Terrestrial Animal Health Code
Terrestrial Animal Health Code
Terrestrial Animal Health Code
Organisation Mondiale de la Santé Animale World Organisation for Animal Health Organización Mundial de Sanidad Animal
TERRESTRIAL
ANIMAL HEALTH
CODE
ISBN 92-9044-635-8
© Copyright
WORLD ORGANISATION FOR ANIMAL HEALTH 2005
12, rue de Prony, 75017 Paris, FRANCE
Telephone: 33-(0)1 44 15 18 88
Fax: 33-(0)1 42 67 09 87
Electronic mail: [email protected]
WWW: http://www.oie.int
All World Organisation for Animal Health (OIE) publications are protected by international copyright
law. Extracts may be copied, reproduced, translated, adapted or published in journals, documents, books,
electronic media and any other medium destined for the public, for information, educational or
commercial purposes, provided prior written permission has been granted by the OIE. The designations
and denominations employed and the presentation of the material in this publication do not imply the
expression of any opinion whatsoever on the part of the OIE concerning the legal status of any country,
territory, city or area or of its authorities, or concerning the delimitation of its frontiers and boundaries.
Foreword
The aim of the Terrestrial Animal Health Code (hereafter referred to as the Terrestrial Code) is to assure the
sanitary safety of international trade in terrestrial animals (mammals, birds and bees) and their products. This is
achieved through the detailing of health measures to be used by the veterinary authorities of importing and exporting
countries to avoid the transfer of agents pathogenic for animals or humans, while avoiding unjustified sanitary barriers.
The health measures in the Terrestrial Code (in the form of standards, guidelines and recommendations) have been
formally adopted by the OIE International Committee, the general assembly of all Delegates of OIE Member
Countries, which constitutes the organisation's highest decision-making body. This 14th edition incorporates the
modifications to the Terrestrial Code agreed by the OIE International Committee during the 73rd General Session
in May 2005. These include revised chapters and appendices on the following subjects: general definitions, notification
and epidemiological information, zoning and compartmentalisation, criteria for listing diseases, foot and mouth disease,
bluetongue, Rift Valley fever, bovine tuberculosis, bovine spongiform encephalopathy, classical swine fever and avian
influenza. Appendices on bovine and small ruminant semen, general surveillance for animal health and surveillance
systems for bovine spongiform encephalopathy, foot and mouth disease, classical swine fever and avian influenza have
also been included. This edition includes four specific animal welfare guidelines (land and sea transport, killing for
disease control purposes and slaughter for human consumption) and revised appendices on the use of antimicrobials.
The development of these standards, guidelines and recommendations is the result of the continuous work of one of the
OIE Specialist Commissions, the OIE Terrestrial Animal Health Standards Commission (in brief 'Terrestrial Code
Commission'). This Commission, which comprises six elected members experienced in regulatory veterinary science
drawn from all OIE regions, meets several times yearly to address its work programme. The Commission draws upon
the expertise of internationally renowned specialists to prepare draft texts for new chapters and appendices of the
Terrestrial Code or to revise existing chapters and appendices in the light of advances in veterinary science. The views
of the Delegates of Member Countries are systematically sought through the circulation of draft and revised texts. As
well, the Terrestrial Code Commission collaborates closely with the OIE Aquatic Animal Health Standards
Commission on issues needing a harmonised approach, and with the Biological Standards Commission and the
Scientific Commission for Animal Diseases to ensure the Terrestrial Code Commission is utilising the latest scientific
information in its work.
The World Trade Organization (WHO) Agreement on the Application of Sanitary and Phytosanitary Measures
(SPS Agreement) conferred on the OIE new responsibilities under international law by specifing 'the standards,
guidelines and recommendations developed under the auspices of the OIE' as the international standards for animal
health and zoonoses. The SPS Agreement is aimed at establishing a multilateral framework of rules and disciplines to
guide the development, adoption and enforcement of sanitary measures in order to minimise their negative effects on
international trade. Essentially, two options are available to Member Countries to provide a scientific justification for
an import health measure. The first, and most encouraged by the WTO, is for veterinary authorities to base their
import health measures on the OIE's international standards, guidelines and recommendations. Where these do not
exist, or in cases where a government chooses to apply stricter measures, the importing country must be able to show
that its measure is based on a scientific assessment of the potential health risks. Guidelines for conducting risk
analyses are described in the Terrestrial Code. The Terrestrial Code thus forms an integral part of the regulatory
reference system established by the WTO.
The Terrestrial Code is published annually in the three official OIE languages (English, French and Spanish), and
more recently in Russian. The contents of the Terrestrial Code are available on the OIE Web site at
http://www.oie.int.
The User's Guide, which follows the foreword, is designed to help veterinary authorities and other interested parties to
use the various chapters of the Terrestrial Code efficiently and effectively, and to promote equitable access by all
developing and developed countries to the world market in animals and animal products, according to their animal
health status.
We wish to thank the members of the Terrestrial Code Commission for their hard work, Delegates and the members
of Working Groups and Ad hoc Groups and other Commissions for their expert advice, and also the staff of OIE
Headquarters for their dedication in producing this 14th edition of the Terrestrial Code.
Dr B. Vallat Dr A. Thiermann
Director General President
World Organisation for Animal Health Terrestrial Code Commission
July 2005
A. General remarks
1. The purpose of this guide is to assist the Veterinary Administrations of OIE Member Countries to use the
Terrestrial Animal Health Code (hereafter referred to as the Terrestrial Code) in developing their animal
health measures applicable to imports and exports of animals and animal products.
2. The recommendations in each of the chapters in Part 2. of the Terrestrial Code are designed to prevent the
disease in question being introduced into the importing country, taking into account the nature of the commodity
and the animal health status of the exporting country. This means that, correctly applied, the recommendations
ensure that the intended importation can take place with an optimal level of animal health security, incorporating
the latest scientific findings and available techniques.
3. The recommendations in the Terrestrial Code make reference only to the animal health situation in the
exporting country, and assume that either the disease is either not present in the importing country or is the
subject of a control or eradication programme. Therefore, when determining its import measures, an importing
country should do so in a way that is consistent with the principle of national treatment and the other provisions
of the WTO SPS Agreement. An importing country is always free to authorise the importation of animals or
animal products into its territory under conditions either more or less stringent than those recommended by the
Terrestrial Code, but this must be based on a scientific risk analysis and done in accordance with the country's
obligations under the SPS Agreement.
4. To avoid confusion, key terms and expressions used in the Terrestrial Code are defined in Chapter 1.1.1.
When preparing model international veterinary certificates, the importing country should endeavour to use these
terms and expressions in accordance with the definitions given in the Terrestrial Code.
5. In general, at the head of each chapter relating to a specific disease (in Part 2 of the Terrestrial Code ), there is
an article listing either the commodities that the OIE considers capable of transmitting the disease through
international trade or those not considered to present a risk. The articles following deal with each of these
commodities in the first group, where necessary taking into account the status of the exporting territory. Where
there is no article for a particular category of commodity, it means that the OIE has not yet been able to develop
a recommendation on the subject and import measures for that commodity should be based on a risk analysis.
6. In many of the Terrestrial Code chapters, the use of diagnostic tests and vaccines is recommended. In each case,
a reference in the first article of the chapter is made to the relevant section in the OIE Manual of Diagnostic
Tests and Vaccines for Terrestrial Animals (hereafter referred to as the Terrestrial Manual). A table
summarising the recommended diagnostic tests may be found in Appendix 3.1.1. of the Terrestrial Code.
7. The importing country is always free to authorise the importation of animals or animal products into its territory
under conditions less stringent than those recommended by the Terrestrial Code, due, for example, to the
enzootic nature of the disease in its own territory or the special importance of the intended importation. It may
also impose stricter sanitary conditions. If the importing country is a Member of the World Trade Organization,
it must ensure that in either case it respects its obligations under the terms of the Agreement on the Application
of Sanitary and Phytosanitary Measures.
8. Section 1.2. of the Terrestrial Code deals with obligations and ethics in international trade. Each Veterinary
Administration should have a sufficient number of copies of the Terrestrial Code to allow all veterinarians
directly involved in such trade to familiarise themselves with the contents. In addition, diagnostic laboratories and
vaccine production units should be fully conversant with the technical recommendations in the Terrestrial Manual.
9. When, in some parts of this Terrestrial Code, the term “(under study)” is applied to an Article or part of an
Article, the meaning is that the text has not been adopted by the OIE International Committee and is not part
of the Terrestrial Code. Accordingly, that recommendation need not be applied by Member Countries.
10. The complete text of the Terrestrial Code has been made available on the OIE Web site (address:
http://www.oie.int) to ensure wider access.
These three OIE publications inform Veterinary Administrations on the animal health situation worldwide.
Importing countries can thus have an overview of the animal health status, disease occurrence and control programmes
in exporting countries. If it considers the data available at the international level to be insufficient, the importing
country should contact the exporting country directly, or through the OIE Central Bureau, to obtain additional
information.
1. An international veterinary certificate is a document, drawn up by the exporting country in accordance with the
terms of Chapter 1.2.1. and Chapter 1.2.2. of the Terrestrial Code, describing the animal health requirements
and, where appropriate, public health requirements for the exported commodity. The assurance given to the
importing country that diseases will not be introduced through the importation of animals or animal products
depends on the quality of the exporting country's veterinary infrastructure and the rigour with which international
veterinary certificates are issued in the exporting country.
2. International veterinary certificates are intended to facilitate trade and should not be used to impede it by
imposing unjustified health conditions. In all cases, the exporting country and the importing country shall refer to
the health conditions recommended in the Terrestrial Code before agreeing on the terms of the certificate. It
would be irresponsible and contrary to the principles of encouraging international trade to insist on guarantees as
to the absence of commonly found infections that are present in the importing country. There may be exceptions to
this general rule, such as for example when the importing country is implementing control programmes for certain
diseases, when the aim is to avoid introducing new strains of disease agents, or when animals to be imported are
intended for elite nucleus herds or flocks which are free of certain diseases and subject to stricter control measures.
3. The steps to be followed when drafting international veterinary certificates are as follows:
a) list the diseases against which the importing country is justified in seeking protection;
b) list the health requirements for each of these diseases, which can be determined by referring to the relevant
articles in the Terrestrial Code. The Terrestrial Code provides for various levels of sanitary status in the
case of many diseases: disease free country or zone, disease free herd, vaccinated or non vaccinated herd;
c) use the model international veterinary certificates presented in Part 4. of the Terrestrial Code as a general
framework, adapting the contents and form of the paragraphs as required, for example by devoting more
space to details of the herd of origin.
4. As stated in Article 1.2.2.2. of the Terrestrial Code, it is important that international veterinary certificates
are kept as simple as possible and are clearly worded, so as to avoid any misunderstanding of the requirements of
importing countries. The same article gives advice on how to draft certificates so as to ensure the validity of their
contents and prevent forgery.
In order to avoid any misunderstanding of the requirements, it is often advisable to prepare notes of guidance to assist
importers and exporters. The notes should set out all the conditions involving importation measures to be applied before
and after importation, as well as during transport and unloading, legal obligations and operational procedures. The
attention of exporters should also be drawn to the rules governing air transport of animals and animal products.
The notes of guidance should also set out in detail the health certification requirements to be included in the documents
accompanying the consignment to its destination.
PART 3 APPENDICES
Appendix 3.4.1. Hygiene and disease security procedures in poultry breeding flocks 379
and hatcheries
Appendix 3.4.2. Hygiene and disease security procedures in apiaries 387
Appendix 3.4.3. Hygiene precautions, identification, blood sampling and 390
vaccination
Appendix 4.1.5. Model passport for international movement of competition horses 591
Appendix 4.1.6. Model International veterinary certificate for birds 607
Appendix 4.1.7. Model international veterinary certificate for day-old birds and 611
hatching eggs
Appendix 4.1.8. Model international veterinary certificate for rabbits 615
Appendix 4.1.9. Model international veterinary certificate for bees and 619
brood-combs
GENERAL PROVISIONS
CHAPTER 1.1.1.
GENERAL DEFINITIONS
Article 1.1.1.1.
Acceptable risk
means a risk level judged by each Member Country to be compatible with the protection of animal
and public health within its territory.
Animal
means a mammal, bird or bee.
Antimicrobial agent
means a naturally occurring, semi-synthetic or synthetic substance that exhibits antimicrobial activity
(kill or inhibit the growth of micro-organisms). Anthelmintics and substances classed as disinfectants
or antiseptics are excluded from this definition.
Apiary
means a hive or group of hives whose management allows them to be considered as a single
epidemiological unit.
Approved
means officially approved, accredited or registered by the Veterinary Administration.
Approved abattoir
means premises used for the slaughter of animals for human consumption or animal feeding and
approved by the Veterinary Administration for export purposes.
Beehive
means a structure for the keeping of honey bee colonies that is being used for that purpose,
including frameless hives, fixed frame hives and all designs of moveable frame hives (including
nucleus hives), but not including packages or cages used to confine bees for the purpose of transport
or isolation.
Border post
means any airport, or any port, railway station or road check-point open to international trade of
commodities, where import veterinary inspections can be performed.
Breeding birds
means birds kept for the purpose of producing hatching eggs.
Buffer zone
means a zone established to protect the health status of animals in a free country or free zone, from
those in a country or zone of a different animal health status, using measures based on the
epidemiology of the disease under consideration to prevent spread of the causative pathogenic agent
into a free country or free zone. These measures may include, but are not limited to, vaccination,
movement control and an intensified degree of disease surveillance.
Case
means an individual animal infected by a pathogenic agent, with or without clinical signs.
Central Bureau
means the Permanent Secretariat of the World Organisation for Animal Health which headquarters
are:
12, rue de Prony, 75017 Paris, FRANCE
Telephone: 33-(0)1 44 15 18 88
Fax: 33-(0)1 42 67 09 87
Electronic mail: [email protected]
WWW: http://www.oie.int
Collecting centre
means premises or place in which animals for breeding or rearing or animals for slaughter coming from
different establishments or markets are collected together and which is:
a) under the control of an Official Veterinarian;
b) not located in an infected zone;
c) used only for animals for breeding or rearing or animals for slaughter which meet the conditions of
this Terrestrial Code;
d) disinfected before and after use.
Collection centre
means a facility approved by the Veterinary Administration for the collection of embryos/ova and
used exclusively for donor animals which meet the conditions of this Terrestrial Code.
Commodity
means animals, products of animal origin intended for human consumption, for animal feeding, for
pharmaceutical or surgical use or for agricultural or industrial use, semen, embryos/ova, biological
products and pathological material.
Compartment
means one or more establishments under a common biosecurity management system containing an
animal subpopulation with a distinct health status with respect to a specific disease or specific diseases
for which required surveillance, control and biosecurity measures have been applied for the purpose
of international trade.
Competent Authority
means the Veterinary Services, or other Authority of a Member Country, having the responsibility and
competence for ensuring or supervising the implementation of the animal health measures or other
standards in the Terrestrial Code.
Day-old birds
means birds aged not more than 72 hours after hatching.
Disease
means the clinical and/or pathological manifestation of infection.
Disinfection
means the application, after thorough cleansing, of procedures intended to destroy the infectious or
parasitic agents of animal diseases, including zoonoses; this applies to premises, vehicles and different
objects which may have been directly or indirectly contaminated.
Disinfestation
means the application of procedures intended to eliminate arthropods which may cause diseases or are
potential vectors of infectious agents of animal diseases, including zoonoses.
Emerging disease
means a new infection resulting from the evolution or change of an existing pathogenic agent, a
known infection spreading to a new geographic area or population, or a previously unrecognized
pathogenic agent or disease diagnosed for the first time and which has a significant impact on animal
or public health.
Epidemiological unit
means a group of animals with a defined epidemiological relationship that share approximately the
same likelihood of exposure to a pathogen. This may be because they share a common environment
(e.g. animals in a pen), or because of common management practices. Usually, this is a herd or a
flock. However, an epidemiological unit may also refer to groups such as animals belonging to residents
of a village, or animals sharing a communal animal handling facitity. The epidemiological relationship
may differ from disease to disease, or even strain to strain of the pathogen.
Eradication
means the elimination of a pathogenic agent from a country or zone.
Establishment
means the premises in which animals are kept.
Exporting country
means a country from which commodities are sent to another country.
Flock of birds
means any group of birds continuously housed in one building or part of a building separated from
other parts of that building by a solid partition and having its own ventilation system, or, in the case
of free range birds, any group of birds having common access to one or more buildings or houses.
More than one flock of birds may exist in one establishment.
Free compartment
means a compartment in which the absence of the animal pathogen causing the disease under
consideration has been demonstrated by all requirements specified in this Terrestrial Code for free
status being met.
Free zone
means a zone in which the absence of the disease under consideration has been demonstrated by the
requirements specified in this Terrestrial Code for free status being met. Within the zone and at its
borders, appropriate official veterinary control is effectively applied for animals and animal products, and
their transportation.
Fresh meat
means meat that has not been subjected to any treatment irreversibly modifying its organoleptic and
physicochemical characteristics. This includes frozen meat, chilled meat, minced meat and
mechanically recovered meat.
Greaves
means the protein-containing residue obtained after the partial separation of fat and water during the
process of rendering.
Hatching eggs
means fertilised bird eggs, suitable for incubation and hatching.
Hazard
means a biological, chemical or physical agent in, or a condition of, an animal or animal product with
the potential to cause an adverse health effect.
Hazard identification
means the process of identifying the pathogenic agents which could potentially be introduced in the
commodity considered for importation.
Importing country
means a country that is the final destination to which commodities are sent.
Incidence
means the number of new cases or outbreaks of a disease that occur in a population at risk in a
particular geographical area within a defined time interval.
Incubation period
means the longest period which elapses between the introduction of the pathogen into the animal
and the occurrence of the first clinical signs of the disease.
Infected zone
means a zone in which the absence of the disease under consideration has not been demonstrated by
the requirements specified in this Terrestrial Code being met.
Infection
means the presence of the pathogenic agent in the host.
Infective period
means the longest period during which an affected animal can be a source of infection.
International trade
means importation, exportation and transit of commodities.
Laboratory
means a properly equipped institution staffed by technically competent personnel under the control
of a specialist in veterinary diagnostic methods, who is responsible for the validity of the results. The
Veterinary Administration approves and monitors such laboratories with regard to the diagnostic tests
required for international trade.
Laying birds
means birds kept for the purpose of producing eggs not intended for hatching.
Listed diseases
means the list of transmissible disease agreed by the OIE International Committee and set out in
Chapter 2.1.1. of this Terrestrial Code.
Market
means a market which is:
a) placed under the control of an Official Veterinarian;
b) not located in an infected zone;
c) used only for animals for breeding or rearing or animals for slaughter which conform with the
conditions provided in this Terrestrial Code;
d) disinfected before and after use.
Meat
means all edible parts of an animal.
Meat-and-bone meal
means the solid protein products obtained when animal tissues are rendered, and includes any
intermediate protein product other than peptides of a molecular weight less than 10,000 daltons and
amino-acids.
Meat products
means meat that has been subjected to a treatment irreversibly modifying its organoleptic and
physicochemical characteristics.
Milk
means the normal mammary secretion of milking animals obtained from one or more milkings
without either addition to it or extraction from it.
Milk product
means the product obtained by any processing of milk.
Monitoring
means the continuous investigation of a given population or subpopulation, and its environment, to
detect changes in the prevalence of a disease or characteristics of a pathogenic agent.
Notifiable disease
means a disease listed by the Veterinary Administration, and that, as soon as detected or suspected,
must be brought to the attention of the Veterinary Authority, in accordance with national regulations.
Notification
means the procedure by which:
a) the Veterinary Administration informs the Central Bureau,
b) the Central Bureau informs Veterinary Administrations,
of the occurrence of an outbreak of disease or infection, according to the provisions of Chapter 1.1.2.
of this Terrestrial Code.
Official Veterinarian
means a veterinarian authorised by the Veterinary Administration of the country to perform certain
designated official tasks associated with animal health and/or public health and inspections of
commodities and, when appropriate, to certify in conformity with the provisions of Section 1.2. of this
Terrestrial Code.
Pathological material
means samples obtained from live or dead animals, containing or suspected of containing infectious
or parasitic agents, to be sent to a laboratory.
Place of shipment
means the place where the commodities are loaded into the vehicle or handed to the agency that will
transport them to another country.
Population
means a group of units sharing a common defined characteristic.
Prevalence
means the total number of cases or outbreaks of a disease that are present in a population at risk, in a
particular geographical area, at one specified time or during a given period.
Quality
is defined by International Standard ISO 8402 as 'the totality of characteristics of an entity that bear
on its ability to satisfy stated and implied needs'.
Quarantine station
means a facility under the control of the Veterinary Authority where a group of animals is maintained
in isolation, with no direct or indirect contact with other animals, in order to undergo observation
for a specified length of time and, if appropriate, testing and treatment.
Risk
means the likelihood of the occurrence and the likely magnitude of the consequences of an adverse
event to animal or human health in the importing country during a specified time period, as a result of a
hazard.
Risk analysis
means the process composed of hazard identification, risk assessment, risk management and risk
communication.
Risk assessment
means the evaluation of the likelihood and the biological and economic consequences of entry,
establishment, or spread of a pathogenic agent within the territory of an importing country.
Risk communication
is the interactive exchange of information on risk among risk assessors, risk managers and other
interested parties.
Risk management
means the process of identifying, selecting and implementing measures that cen be applied to reduce
the level of risk.
Sanitary measure
means any measure applied to protect animal or human health or life within the territory of the
Member Country from risks arising from the entry, establishment or spread of a hazard. [Note: A
detailed definition of sanitary measure may be found in the Agreement on the Application of Sanitary and
Phytosanitary Measures of the World Trade Organization.]
Specific surveillance
means the surveillance targeted to a specific disease or infection.
Stamping-out policy
means carrying out under the authority of the Veterinary Administration, on confirmation of a disease,
the killing of the animals which are affected and those suspected of being affected in the herd and,
where appropriate, those in other herds which have been exposed to infection by direct animal to
animal contact, or by indirect contact of a kind likely to cause the transmission of the causal
pathogen. All susceptible animals, vaccinated or unvaccinated, on an infected premises should be
killed and their carcasses destroyed by burning or burial, or by any other method which will eliminate
the spread of infection through the carcasses or products of the animals killed.
This policy should be accompanied by the cleansing and disinfection procedures defined in this
Terrestrial Code.
The term modified stamping-out policy should be used in communications to the OIE whenever the
above animal health measures are not implemented in full and details of the modifications should be
given.
Subpopulation
means a distinct part of a population identifiable according to specific common animal health
characteristics.
Surveillance
means the investigation of a given population or subpopulation to detect the presence of a pathogenic
agent or disease; the frequency and type of surveillance will be determined by the epidemiology of the
pathogenic agent or disease, and the desired outputs.
Surveillance zone
means a zone established within, and along the border of, a free zone separating the free zone from an
infected zone.
The surveillance zone should have an intensified degree of surveillance.
Terrestrial Code
means the OIE Terrestrial Animal Health Code.
Terrestrial Manual
means the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals.
Transit country
means a country through which commodities destined for an importing country are transported or in
which a stopover is made at a border post.
Transparency
means the comprehensive documentation of all data, information, assumptions, methods, results,
discussion and conclusions used in the risk analysis. Conclusions should be supported by an objective
and logical discussion and the document should be fully referenced.
Uncertainty
means the lack of precise knowledge of the input values which is due to measurement error or to
lack of knowledge of the steps required, and the pathways from hazard to risk, when building the
scenario being assessed.
Unit
means an individually identifiable element used to describe, for example, the members of a population
or the elements selected when sampling; examples of units include individual animals, herds, flocks
and apiaries.
Vaccination
means the successful immunisation of susceptible animals through the administration of a vaccine
comprising antigens appropriate to the disease to be controlled.
Variability
means a real-world complexity in which the value of an input is not the same for each case due to
natural diversity in a given population.
Vehicle
Veterinarian
means a person registered or licensed by the relevant Veterinary statutory body of a country to practice
veterinary medicine/science in that country.
Veterinary Administration
means the governmental Veterinary Service having authority in the whole country for implementing
the animal health measures and international veterinary certification process which the OIE
recommends, and supervising or auditing their application.
Veterinary Authority
means a Veterinary Service, under the authority of the Veterinary Administration, which is directly
responsible for the application of animal health measures in a specified area of the country. It may
also have responsibility for the issuing or the supervision of the issuing of international veterinary
certificates in that area.
Veterinary para-professional
means a person who, for the purposes of this Terrestrial Code, is authorised by the Veterinary statutory
body to carry out certain designated tasks (dependent upon the category of veterinary para-professional)
in a country, and delegated to them under the responsibility and direction of a veterinarian. The tasks
authorized for each category of veterinary para-professional should be defined by the Veterinary statutory
body depending on qualifications and training, and according to need.
Veterinary Services
means the Veterinary Administration, all the Veterinary Authorities, and all persons authorised,
registered or licensed by the Veterinary statutory body.
Zone/region
means a clearly defined part of a country containing an animal subpopulation with a distinct health
status with respect to a specific disease for which required surveillance, control and biosecurity
measures have been applied for the purpose of international trade.
Zoonosis
means any disease or infection which is naturally transmissible from animals to humans.
NOTIFICATION AND
EPIDEMIOLOGICAL INFORMATION
Article 1.1.2.1.
For the purposes of this Terrestrial Code and in terms of Articles 5, 9 and 10 of the Statutes, every
Member Country of the OIE shall recognise the right of the Central Bureau to communicate directly with
the Veterinary Administration of its territory or territories.
All notifications and all information sent by the OIE to the Veterinary Administration shall be regarded as
having been sent to the country concerned and all notifications and all information sent to the OIE by the
Veterinary Administration shall be regarded as having been sent by the country concerned.
Article 1.1.2.2.
1. Countries shall make available to other countries, through the OIE, whatever information is
necessary to minimise the spread of important animal diseases and to assist in achieving better
worldwide control of these diseases.
2. To achieve this, countries shall comply with the notification requirements specified in Article 1.1.2.3.
3. To assist in the clear and concise exchange of information, reports shall conform as closely as
possible to the official OIE disease reporting format.
4. Recognising that scientific knowledge concerning the relationship between disease agents and diseases
is constantly developing and that the presence of an infectious agent does not necessarily imply the
presence of a disease, countries shall ensure through their reports that they comply with the spirit and
intention of paragraph 1 above.
5. In addition to notifying new findings in accordance with Article 1.1.2.3., countries shall also provide
information on the measures taken to prevent the spread of diseases; including quarantine measures
and restrictions on the movement of animals, animal products and biological products and other
miscellaneous objects which could by their nature be responsible for transmission of disease. In the
case of diseases transmitted by vectors, the measures taken against such vectors shall also be
specified.
Article 1.1.2.3.
Article 1.1.2.4.
1. The Veterinary Administration of a territory in which an infected zone was located shall inform the
Central Bureau when this zone is free from the disease.
2. An infected zone for a particular disease shall be considered as such until a period exceeding the
infective period specified in this Terrestrial Code has elapsed after the last reported case, and when full
prophylactic and appropriate animal health measures have been applied to prevent possible
reappearance or spread of the disease. These measures will be found in detail in the various chapters
of Section 2.2. of this Terrestrial Code.
3. A country may be considered to regain freedom from a specific disease when all conditions given in
the relevant chapters of this Terrestrial Code have been fulfilled.
4. The Veterinary Administration of a country which sets up one or several free zones shall inform the
OIE giving necessary details, including the criteria on which the free status is based, the requirements
for maintaining the status and indicating clearly the location of the zones on a map of the country.
Article 1.1.2.5.
1. The Central Bureau shall send by telegram, fax, e-mail or Disease Information to the Veterinary
Administrations concerned, all notifications received as provided in Articles 1.1.2.2. to 1.1.2.4.
2. The Central Bureau shall dispatch to the Delegates information on new outbreaks of listed diseases.
3. The Central Bureau, on the basis of information received and of any official communication, shall
prepare an annual report concerning the application of this Terrestrial Code and its effects on
international trade.
Article 1.1.2.6.
All telegrams or faxes sent by Veterinary Administrations in pursuance of Articles 1.1.2.3. and 1.1.2.5. shall
receive priority in accordance with the circumstances. Communications by telephone, telegram or fax,
sent in the case of exceptional urgency when there is danger of spread of a notifiable epizootic disease,
shall be given the highest priority accorded to these communications by the International Arrangements
of Telecommunications.
CHAPTER 1.2.1.
GENERAL OBLIGATIONS
Article 1.2.1.1.
International trade in animals and animal products depends on a combination of factors which should be
taken into account to ensure unimpeded trade, without incurring unacceptable risks to human and animal
health.
Because of the likely variations in animal health situations, various options are offered by the Terrestrial
Code. The animal health situation in the exporting country, in the transit country or countries and in the
importing country should be considered before determining the requirements which have to be met for
trade. To maximise harmonisation of the sanitary aspects of international trade, Veterinary Administrations
of Member Countries should base their import requirements on the OIE standards, guidelines and
recommendations.
These requirements should be included in the model certificates approved by the OIE which form Part 4
of this Terrestrial Code.
Certification requirements should be exact and concise, and should clearly convey the wishes of the
importing country. For this purpose, prior consultation between Veterinary Administrations of importing and
exporting countries is useful and may be necessary. It enables the setting out of the exact requirements so
that the signing veterinarian can, if necessary, be given a note of guidance explaining the understanding
between the Veterinary Administrations involved.
When Members of a Veterinary Administration wish to visit another country for matters of professional
interest to the Veterinary Administration of the other country, the latter should be informed.
Article 1.2.1.2.
1. The import requirements included in the international veterinary certificate should assure that
commodities introduced into the importing country comply with the national level of protection that it
has chosen for animal and human health. Importing countries should restrict their requirements to
those justified for such level of protection.
2. The international veterinary certificate should not include requirements for the exclusion of pathogens
or animal diseases which are present within the territory of the importing country and are not subject to
any official control programme. The requirements applying to pathogens or diseases subject to official
control programmes in a country or zone should not provide a higher level of protection on imports
than that provided for the same pathogens or diseases by the measures applied within that country or
zone.
3. The international veterinary certificate should not include requirements for disease agents or diseases
which are not OIE listed, unless the importing country has identified the disease agent as presenting a
significant risk for that country, after conducting a scientifically based import risk analysis according
to the guidelines in Section 1.3.
4. The transmission by the Veterinary Administration of certificates or the communication of import
requirements to persons other than the Veterinary Administration of another country, necessitates
that copies of these documents are also sent to the Veterinary Administration. This important
procedure avoids delays and difficulties which may arise between traders and Veterinary
Administrations when the authenticity of the certificates or permits is not established.
This information is usually the responsibility of Veterinary Administrations. However, it can be the
responsibility of Veterinary Authorities at the place of origin of the animals when it is agreed that the
issue of certificates does not require the approval of the Veterinary Administration.
Article 1.2.1.3.
1. An exporting country should be prepared to supply the following information to importing countries on
request:
a) information on the animal health situation and national animal health information systems to
determine whether that country is free or has free zones of listed diseases, including the
regulations and procedures in force to maintain its free status;
b) regular and prompt information on the occurrence of transmissible diseases;
c) details of the country's ability to apply measures to control and prevent the relevant listed
diseases;
d) information on the structure of the Veterinary Services and the authority which they exercise;
e) technical information, particularly on biological tests and vaccines applied in all or part of the
national territory.
2. Veterinary Administrations of exporting countries should:
a) have official procedures for authorisation of certifying veterinarians, defining their functions
and duties as well as conditions covering possible suspension and termination of the
appointment;
b) ensure that the relevant instructions and training are provided to certifying veterinarians;
c) monitor the activities of the certifying veterinarians to verify their integrity and impartiality.
3. The Head of the Veterinary Service of the exporting country is ultimately accountable for veterinary
certification used in international trade.
Article 1.2.1.4.
International trade involves a continuing ethical responsibility. Therefore, if within the recognised incubation
periods of the various diseases subsequent to an export taking place, the Veterinary Administration becomes
aware of the appearance or reappearance of a disease which has been specifically included in the
international veterinary certificate, there is an obligation for the Administration to notify the importing country,
so that the imported stock may be inspected or tested and appropriate action be taken to limit the spread
of the disease should it have been inadvertently introduced.
Equally, if a disease condition appears in imported stock within a time period after importation consistent
with the recognised incubation period of the disease, the Veterinary Administration of the exporting country
should be informed so as to enable an investigation to be made, since this may be the first available
information on the occurrence of the disease in a previously free herd. The Veterinary Administration of the
importing country should be informed of the result of the investigation since the source of infection may
not be in the exporting country.
CERTIFICATION PROCEDURES
Article 1.2.2.1.
Certification should be based on the highest possible ethical standards, the most important of which is
that the professional integrity of the certifying veterinarian must be respected and safeguarded.
It is essential not to include in the requirements additional specific matters which cannot be accurately
and honestly signed by a veterinarian. For example, these requirements should not include certification of
an area as being free from non-notifiable diseases the occurrence of which the signing veterinarian is not
necessarily informed about. Equally, to ask certification for events which will take place after the
document is signed is unacceptable when these events are not under the direct control and supervision of
the signing veterinarian.
Certification of freedom from diseases based on purely clinical freedom and herd history is of limited
value. This is also true of diseases for which there is no specific diagnostic test, or the value of the test as
a diagnostic aid is limited.
The note of guidance referred to in Article 1.2.1.1. is not only to inform the signing veterinarian but also
to safeguard professional integrity.
Article 1.2.2.2.
Article 1.2.2.3.
Certifying veterinarians
1. be authorised by the Veterinary Administration of the exporting country to sign international veterinary
certificates;
2. only certify matters that are within their own knowledge at the time of signing the certificate, or that
have been separately attested by another competent party;
3. sign only at the appropriate time certificates that have been completed fully and correctly; where a
certificate is signed on the basis of supporting documentation, the certifying veterinarian should be
in possession of that documentation before signing;
4. have no conflict of interest in the commercial aspects of the animals or animal products being
certified and be independent from the commercial parties.
Article 1.2.2.4.
Electronic certification
1. Certification may be provided by electronic documentation sent directly from the Veterinary
Administration of the exporting country to the Veterinary Administration of the importing country. Such
systems also normally provide an interface with the commercial organisation marketing the commodity
for provision of information to the certifying authority. The certifying veterinarian must have access
to all information such as laboratory results and animal identification data.
3. The Veterinary Administration must have in place systems for the security of electronic certificates
against access by unauthorised persons or organisations.
4. The certifying veterinarian must be officially responsible for the secure use of his/her electronic
signature.
RISK ANALYSIS
CHAPTER 1.3.1.
GENERAL CONSIDERATIONS
Article 1.3.1.1.
Introduction
The importation of animals and animal products involves a degree of disease risk to the importing country.
This risk may be represented by one or several diseases or infections.
The principal aim of import risk analysis is to provide importing countries with an objective and defensible
method of assessing the disease risks associated with the importation of animals, animal products, animal
genetic material, feedstuffs, biological products and pathological material. The analysis should be
transparent. This is necessary so that the exporting country is provided with clear reasons for the imposition
of import conditions or refusal to import.
Transparency is also essential because data are often uncertain or incomplete and, without full
documentation, the distinction between facts and the analyst's value judgements may blur.
This Chapter alludes to the role of the OIE with respect to the Agreement on the Application of Sanitary
and Phytosanitary Measures (the so-called SPS Agreement) of the World Trade Organization (WTO),
provides definitions and describes the OIE in-house procedure for settlement of disputes.
Chapter 1.3.2. provides guidelines and principles for conducting transparent, objective and defensible risk
analyses for international trade. The components of risk analysis described in that Chapter are hazard
identification, risk assessment, risk management and risk communication (Figure 1).
Fig. 1. The four components of risk analysis
The risk assessment is the component of the analysis which estimates the risks associated with a hazard.
Risk assessments may be qualitative or quantitative. For many diseases, particularly for those diseases listed
in this Terrestrial Code where there are well developed internationally agreed standards, there is broad
agreement concerning the likely risks. In such cases it is more likely that a qualitative assessment is all that
is required. Qualitative assessment does not require mathematical modelling skills to carry out and so is
often the type of assessment used for routine decision making. No single method of import risk
assessment has proven applicable in all situations, and different methods may be appropriate in different
circumstances.
The process of import risk analysis usually needs to take into consideration the results of an evaluation of
Veterinary Services, zoning, compartmentalisation and surveillance systems in place for monitoring of
animal health in the exporting country. These are described in separate Chapters in this Terrestrial Code.
Article 1.3.1.2.
The Agreement on the Application of Sanitary and Phytosanitary Measures and role and
responsibility of the OIE
The SPS Agreement encourages WTO Members to base their sanitary measures on international standards,
guidelines and recommendations, where they exist. Members may choose to adopt a higher level of
protection than that provided by international texts if there is a scientific justification or if the level of
protection provided by the relevant international texts is considered to be inappropriate. In such
circumstances, Members are subject to obligations relating to risk assessment and to a consistent approach
of risk management.
The SPS Agreement encourages Governments to make a wider use of risk analysis: WTO Members shall
undertake an assessment as appropriate to the circumstances of the actual risk involved.
The SPS Agreement recognises the OIE as the relevant international organisation responsible for the
development and promotion of international animal health standards, guidelines, and recommendations
affecting trade in live animals and animal products.
Article 1.3.1.3.
OIE shall maintain its existing voluntary in-house mechanisms for assisting Member Countries to resolve
differences. In-house procedures which will apply are that:
1. Both parties agree to give the OIE a mandate to assist them in resolving their differences.
2. If considered appropriate, the Director General of the OIE recommends an expert, or experts, and a
chairman, as requested, agreed by both parties.
3. Both parties agree on the terms of reference and working programme, and to meet all expenses
incurred by the OIE.
4. The expert or experts are entitled to seek clarification of any of the information and data provided by
either country in the assessment or consultation processes, or to request additional information or
data from either country.
5. The expert or experts shall submit a confidential report to the Director General, who will transmit it
to both parties.
Article 1.3.2.1.
Introduction
An import risk analysis begins with a description of the commodity proposed for import and the likely
annual quantity of trade. It must be recognised that whilst an accurate estimate of the anticipated quantity
of trade is desirable to incorporate into the risk estimate, it may not be readily available, particularly where
such trade is new.
Hazard identification is an essential step which must be conducted before the risk assessment.
The risk assessment process consists of four interrelated steps. These steps clarify the stages of the risk
assessment, describing them in terms of the events necessary for the identified potential risk(s) to occur,
and facilitate understanding and evaluation of the outputs. The product is the risk assessment report which
is used in risk communication and risk management.
The relationships between risk assessment and risk management processes are outlined in Figure 1.
Fig. 1. The relationship between risk assessment and risk management processes
Article 1.3.2.2.
Hazard identification
The hazard identification involves identifying the pathogenic agents which could potentially produce
adverse consequences associated with the importation of a commodity.
The potential hazards identified would be those appropriate to the species being imported, or from which
the commodity is derived, and which may be present in the exporting country. It is then necessary to identify
whether each potential hazard is already present in the importing country, and whether it is a notifiable disease
or is subject to control or eradication in that country and to ensure that import measures are not more
trade restrictive than those applied within the country.
Hazard identification is a categorisation step, identifying biological agents dichotomously as potential
hazards or not. The risk assessment may be concluded if hazard identification fails to identify potential
hazards associated with the importation.
The evaluation of the Veterinary Services, surveillance and control programmes and zoning and
compartmentalisation systems are important inputs for assessing the likelihood of hazards being present in
the animal population of the exporting country.
An importing country may decide to permit the importation using the appropriate sanitary standards
recommended in this Terrestrial Code, thus eliminating the need for a risk assessment.
Article 1.3.2.3.
1. Risk assessment should be flexible to deal with the complexity of real life situations. No single method
is applicable in all cases. Risk assessment must be able to accommodate the variety of animal
commodities, the multiple hazards that may be identified with an importation and the specificity of each
disease, detection and surveillance systems, exposure scenarios and types and amounts of data and
information.
2. Both qualitative risk assessment and quantitative risk assessment methods are valid.
3. The risk assessment should be based on the best available information that is in accord with current
scientific thinking. The assessment should be well-documented and supported with references to the
scientific literature and other sources, including expert opinion.
4. Consistency in risk assessment methods should be encouraged and transparency is essential in order to
ensure fairness and rationality, consistency in decision making and ease of understanding by all the
interested parties.
5. Risk assessments should document the uncertainties, the assumptions made, and the effect of these on
the final risk estimate.
6. Risk increases with increasing volume of commodity imported.
7. The risk assessment should be amenable to updating when additional information becomes available.
Article 1.3.2.4.
1. Release assessment
Release assessment consists of describing the biological pathway(s) necessary for an importation
activity to 'release' (that is, introduce) pathogenic agents into a particular environment, and estimating
the probability of that complete process occurring, either qualitatively (in words) or quantitatively (as
a numerical estimate). The release assessment describes the probability of the 'release' of each of the
potential hazards (the pathogenic agents) under each specified set of conditions with respect to
amounts and timing, and how these might change as a result of various actions, events or measures.
Examples of the kind of inputs that may be required in the release assessment are:
a) Biological factors
- species, age and breed of animals
- agent predilection sites
- vaccination, testing, treatment and quarantine.
b) Country factors
- incidence/prevalence
- evaluation of Veterinary Services, surveillance and control programmes and zoning systems
of the exporting country.
c) Commodity factors
- quantity of commodity to be imported
- ease of contamination
- effect of processing
- effect of storage and transport.
If the release assessment demonstrates no significant risk, the risk assessment conclude.
2. Exposure assessment
Exposure assessment consists of describing the biological pathway(s) necessary for exposure of
animals and humans in the importing country to the hazards (in this case the pathogenic agents)
released from a given risk source, and estimating the probability of the exposure(s) occurring, either
qualitatively (in words) or quantitatively (as a numerical estimate).
The probability of exposure to the identified hazards is estimated for specified exposure conditions
with respect to amounts, timing, frequency, duration of exposure, routes of exposure (e.g. ingestion,
inhalation, or insect bite), and the number, species and other characteristics of the animal and human
populations exposed. Examples of the kind of inputs that may be required in the exposure
assessment are:
a) Biological factors
- properties of the agent.
b) Country factors
- presence of potential vectors
- human and animal demographics
- customs and cultural practices
- geographical and environmental characteristics.
c) Commodity factors
- quantity of commodity to be imported
- intended use of the imported animals or products
- disposal practices.
If the exposure assessment demonstrates no significant risk, the risk assessment may conclude at this
step.
3. Consequence assessment
Consequence assessment consists of describing the relationship between specified exposures to a
biological agent and the consequences of those exposures. A causal process must exist by which
exposures produce adverse health or environmental consequences, which may in turn lead to
socio-economic consequences. The consequence assessment describes the potential consequences of
a given exposure and estimates the probability of them occurring. This estimate may be either
qualitative (in words) or quantitative (a numerical estimate). Examples of consequences include:
a) Direct consequences
- animal infection, disease, and production losses
- public health consequences.
b) Indirect consequences
- surveillance and control costs
- compensation costs
- potential trade losses
- adverse consequences to the environment.
4. Risk estimation
Risk estimation consists of integrating the results from the release assessment, exposure assessment,
and consequence assessment to produce overall measures of risks associated with the hazards
identified at the outset. Thus risk estimation takes into account the whole of the risk pathway from
hazard identified to unwanted outcome.
For a quantitative assessment, the final outputs may include:
- estimated numbers of herds, flocks, animals or people likely to experience health impacts of
various degrees of severity over time;
- probability distributions, confidence intervals, and other means for expressing the uncertainties in
these estimates;
- portrayal of the variance of all model inputs;
- a sensitivity analysis to rank the inputs as to their contribution to the variance of the risk
estimation output;
- analysis of the dependence and correlation between model inputs.
Article 1.3.2.5.
1. Risk assessment is the process of deciding upon and implementing measures to achieve the Member
Country's appropriate level of protection, whilst at the same time ensuring that negative effects on
trade are minimised. The objective is to manage risk appropriately to ensure that a balance is
achieved between a country's desire to minimise the likelihood or frequency of disease incursions
and their consequences and its desire to import commodities and fulfil its obligations under
international trade agreements.
2. The international standards of the OIE are the preferred choice of sanitary measures for risk
management. The application of these sanitary measures should be in accordance with the intentions in
the standards.
Article 1.3.2.6.
1. Risk evaluation - the process of comparing the risk estimated in the risk assessment with the Member
Country's appropriate level of protection.
2. Option evaluation - the process of identifying, evaluating the efficacy and feasibility of, and selecting
measures in order to reduce the risk associated with an importation in line with the Member
Country's appropriate level of protection. The efficacy is the degree to which an option reduces the
likelihood and/or magnitude of adverse health and economic consequences. Evaluating the efficacy
of the options selected is an iterative process that involves their incorporation into the risk assessment
and then comparing the resulting level of risk with that considered acceptable. The evaluation for
feasibility normally focuses on technical, operational and economic factors affecting the
implementation of the risk management options.
3. Implementation - the process of following through with the risk management decision and ensuring
that the risk management measures are in place.
4. Monitoring and review - the ongoing process by which the risk management measures are
continuously audited to ensure that they are achieving the results intended.
Article 1.3.2.7.
1. Risk communication is the process by which information and opinions regarding hazards and risks are
gathered from potentially affected and interested parties during a risk analysis, and by which the
results of the risk assessment and proposed risk management measures are communicated to the
decision-makers and interested parties in the importing and exporting countries. It is a multidimensional
and iterative process and should ideally begin at the start of the risk analysis process and continue
throughout.
2. A risk communication strategy should be put in place at the start of each risk analysis.
3. The communication of the risk should be an open, interactive, iterative and transparent exchange of
information that may continue after the decision on importation.
4. The principal participants in risk communication include the authorities in the exporting country and
other stakeholders such as domestic and foreign industry groups, domestic livestock producers and
consumer groups.
5. The assumptions and uncertainty in the model, model inputs and the risk estimates of the risk
assessment should be communicated.
6. Peer review is a component of risk communication in order to obtain scientific critique and to ensure
that the data, information, methods and assumptions are the best available.
Article 1.3.3.1.
The quality of the Veterinary Services depends on a set of factors, which include fundamental principles of
an ethical, organisational and technical nature. The Veterinary Services shall conform to these fundamental
principles, regardless of the political, economic or social situation of their country.
Compliance with these fundamental principles by the Veterinary Services of a Member Country is
important to the establishment and maintenance of confidence in its international veterinary certificates by
the Veterinary Services of other Member Countries.
The same fundamental principles should apply in countries where the responsibility for establishing or
applying certain animal health measures, or issuing some international veterinary certificates is exercised by an
organisation other than the Veterinary Services, or by an authority or agency on behalf of the Veterinary
Services. In all cases, the Veterinary Services retain ultimate responsibility for the application of these
principles.
These fundamental principles are presented in Article 1.3.3.2. The remaining factors of quality are
described in Part 1. (notification, principles of certification, etc.) and the document entitled “Guidelines
for the evaluation of Veterinary Services” included in Chapter 1.3.4.
The quality of Veterinary Services can be measured through an evaluation, whose general principles are
described in Article 1.3.3.3. and in Article 1.3.3.4.
Article 1.3.3.2.
The Veterinary Services shall comply with the following principles to ensure the quality of their activities:
1. Professional judgement
The personnel of Veterinary Services should have the relevant qualifications, scientific expertise and
experience to give them the competence to make sound professional judgements.
2. Independence
Care should be taken to ensure that Veterinary Services' personnel are free from any commercial,
financial, hierarchical, political or other pressures which might affect their judgement or decisions.
3. Impartiality
The Veterinary Services should be impartial. In particular, all the parties affected by their activities
have a right to expect their services to be delivered under reasonable and non-discriminatory
conditions.
4. Integrity
The Veterinary Services should guarantee that the work of each of their personnel is of a consistently
high level of integrity. Any fraud, corruption or falsification should be identified and corrected.
5. Objectivity
The Veterinary Services should at all times act in an objective, transparent and non-discriminatory
manner.
6. General organisation
The Veterinary Services must be able to demonstrate by means of appropriate legislation, sufficient
financial resources and effective organisation that they are in a position to have control of the
establishment and application of animal health measures, and of international veterinary certification
activities. Legislation should be suitably flexible to allow for judgements of equivalence and efficient
responses to changing situations. In particular, they should define and document the responsibilities
and structure of the organisations in charge of the animal identification system, control of animal
movements, animal disease control and reporting systems, epidemiological surveillance and
communication of epidemiological information.
A similar demonstration should be made by Veterinary Services when they are in charge of veterinary
public health activities.
The Veterinary Services should have at their disposal effective systems for animal disease surveillance
and for notification of disease problems wherever they occur, in accordance with the provisions of
this Terrestrial Code. Adequate coverage of animal populations should also be demonstrated. They
should at all times endeavour to improve their performance in terms of animal health information
systems and animal disease control.
The Veterinary Services should define and document the responsibilities and structure of the
organisation (in particular the chain of command) in charge of issuing international veterinary
certificates.
Each position within the Veterinary Services which has an impact on their quality should be described.
These job descriptions should include the requirements for education, training, technical knowledge
and experience.
7. Quality policy
The Veterinary Services should define and document their policy and objectives for, and commitment
to, quality, and should ensure that this policy is understood, implemented and maintained at all levels
in the organisation. Where conditions allow, they may implement a quality system corresponding to
their areas of activity and appropriate for the type, range and volume of work that they have to
perform. The guidelines for the quality and evaluation of Veterinary Services propose a suitable
reference system, which should be used if a Member Country choose to adopt a quality system.
8. Procedures and standards
The Veterinary Services should develop and document appropriate procedures and standards for all
providers of relevant activities and associated facilities. These procedures and standards may for
example relate to:
a) programming and management of activities, including international veterinary certification
activities;
b) prevention, control and notification of disease outbreaks;
c) risk analysis, epidemiological surveillance and zoning;
d) inspection and sampling techniques;
e) diagnostic tests for animal diseases;
f) preparation, production, registration and control of biological products for use in the diagnosis
or prevention of diseases;
g) border controls and import regulations;
h) disinfection and disinfestation;
i) treatments intended to destroy, if appropriate, pathogens in animal products.
Inasmuch as the OIE has adopted standards on these matters, the Veterinary Services should comply
with these standards when applying animal health measures and when issuing international veterinary
certificates.
Article 1.3.3.3.
For the purposes of this Terrestrial Code, every Member Country should recognise the right of another
Member Country to undertake, or request it to undertake, an evaluation of its Veterinary Services where the
initiating Member Country is an actual or a prospective importer or exporter of commodities and where the
evaluation is to be a component of a risk analysis process which is to be used to determine or review
sanitary measures which apply to such trade.
Any evaluation of Veterinary Services should be conducted having regard to the OIE Guidelines for the
evaluation of Veterinary Services presented in Chapter 1.3.4. of this Terrestrial Code.
A Member Country has the right to expect that the evaluation of its Veterinary Services will be conducted
in an objective manner. A Member Country undertaking evaluation should be able to justify any measure
taken as a consequence of its evaluation.
Article 1.3.3.4.
A Member Country which intends to conduct an evaluation of another Member Country's Veterinary
Services should give them notice in writing. This notice should define the purpose of the evaluation and
details of the information required.
On receipt of a formal request for information to enable an evaluation of its Veterinary Services by another
Member Country, and following bilateral agreement of the evaluation process and criteria, a Member
Country should expeditiously provide the other country with meaningful and accurate information of the
type requested.
The evaluation process should take into account the fundamental principles and other factors of quality
laid down in Article 1.3.3.1. and in Article 1.3.3.2. It should also take into consideration the specific
circumstances regarding quality, as described in Article 1.3.3.1., prevailing in the countries concerned.
The outcome of the evaluation conducted by a Member Country should be provided in writing as soon as
possible, and in any case within 4 months of receipt of the relevant information, to the Member Country
which has undergone the evaluation. The evaluation report should detail any findings which affect trade
prospects. The Member Country which conducts the evaluation should clarify in detail any points of the
evaluation on request.
In the event of a dispute between two Member Countries over the conduct or the conclusions of the
evaluation of the Veterinary Services, the matter should be dealt with having regard to the procedures set
out in Article 1.3.1.3.
Article 1.3.4.1.
General considerations
1. Evaluation of Veterinary Services is an important element in the risk analysis process which countries
may legitimately use in their policy formulations directly applying to animal health and sanitary
controls of international trade in animals, animal-derived products, animal genetic material and animal
feedstuffs.
Any evaluation should be carried out with due regard for Chapter 1.3.3. of this Terrestrial Code.
2. In order to ensure that objectivity is maximised in the evaluation process, it is essential for some
standards of discipline to be applied. The OIE has developed these guidelines which can be
practically applied to the evaluation of Veterinary Services. These are relevant for evaluation of the
Veterinary Services of one country by those of another country for the purposes of risk analysis in
international trade. The guidelines are also applicable for evaluation by a country of its own Veterinary
Services – the process known as self-evaluation or self-assessment – and for periodic re-evaluation.
In carrying out a risk analysis prior to deciding the sanitary/zoosanitary conditions for the
importation of a commodity, an importing country is justified in regarding its evaluation of the Veterinary
Services of the exporting country as critical.
3. The purpose of evaluation may be either to assist a national authority in the decision-making process
regarding priorities to be given to its own Veterinary Services (self-evaluation) or to assist the process
of risk analysis in international trade in animals and animal-derived products to which official sanitary
and/or zoosanitary controls apply.
4. In both situations, the evaluation should demonstrate that the Veterinary Services have the capability
for effective control of the sanitary and zoosanitary status of animals and animal products. Key
elements to be covered in this process include resource adequacy, management capability, legislative
and administrative infrastructures, independence in the exercise of official functions and
performance history, including disease reporting.
5. Competence and integrity are qualities on which others base their confidence in individuals or
organisations. Mutual confidence between relevant official Veterinary Services of trading partner
countries contributes fundamentally to stability in international trade in animals and animal-related
products. In this situation, scrutiny is directed more at the exporting country than at the importing
country.
6. Although quantitative data can be provided on Veterinary Services, the ultimate evaluation will be
essentially qualitative. While it is appropriate to evaluate resources and infrastructure (organisational,
administrative and legislative), it is also appropriate to place emphasis on the evaluation of the quality
of outputs and performance of Veterinary Services. Evaluation should take into consideration any
quality systems used by Veterinary Services.
7. An importing country has a right of assurance that information on sanitary/zoosanitary situations
provided by the Veterinary Services of an exporting country is objective, meaningful and correct.
Furthermore, the Veterinary Services of the importing country are entitled to expect validity in the
veterinary certification of export.
8. An exporting country is entitled to expect that its animals and animal products will receive reasonable
and valid treatment when they are subjected to import inspection in the country of destination. The
country should also be able to expect that any evaluation of its standards and performance will be
conducted on a non-discriminatory basis. The importing country should be prepared and able to
defend any position which it takes as a consequence of the evaluation.
9. As the Veterinary statutory body is not a part of the Veterinary Services, an evaluation of that body
should be carried out to ensure that the registration/licensing of veterinarians and authorisation of
veterinary para-professionals is included.
Article 1.3.4.2.
Scope
1. In the evaluation of Veterinary Services, the following items may be considered, depending on the
purpose of the evaluation:
- organisation, structure and authority of the Veterinary Services;
- human resources;
- material (including financial) resources;
- functional capabilities and legislative support;
- animal health and veterinary public health controls;
- formal quality systems including quality policy;
- performance assessment and audit programmes;
- participation in OIE activities and compliance with OIE Member Countries’ obligations.
2. To complement the evaluation of Veterinary Services, it is necessary to also consider the organisation
structure and functioning of the Veterinary statutory body.
3. Article 1.3.4.14. outlines appropriate information requirements for:
- self-evaluation by national Veterinary Services which perceive a need to prepare information for
national or international purposes;
- evaluation by a prospective or actual importing country of the Veterinary Services of a prospective
or actual exporting country;
- verification or re-verification of an evaluation in the course of a visit to the exporting country by
the importing country.
Article 1.3.4.3.
1. A key element in the evaluation is the study of the organisation and structure of the official
Veterinary Services. The Veterinary Services should define and set out their policy, objectives and
commitment to quality systems and standards. These organisational and policy statements should be
described in detail. Organisational charts and details of functional responsibilities of staff should be
available for evaluation. The role and responsibility of the Chief Veterinary Officer/Veterinary
Director should be clearly defined. Lines of command should also be described.
2. The organisational structure should also clearly set out the interface relationships of government
Ministers and departmental Authorities with the Chief Veterinary Officer/Veterinary Director and
the Veterinary Services. Formal relationships with statutory authorities and with industry organisations
and associations should also be described. It is recognised that Services may be subject to changes in
structure from time to time. Major changes should be notified to trading partners so that the effects
of re-structuring may be assessed.
3. Organisational components of Veterinary Services which have responsibility for key functional
capabilities should be identified. These capabilities include epidemiological surveillance, disease
control, import controls, animal disease reporting systems, animal identification systems, traceability
systems, animal movement control systems, communication of epidemiological information, training,
inspection and certification. Laboratory and field systems and their organisational relationships
should be described.
4. To reinforce the reliability and credibility of their services, the Veterinary Services may have set up
quality systems that correspond with their fields of activity and to the nature and scale of activities
that they carry out. Evaluation of such systems should be as objective as possible.
5. The Veterinary Administration alone speaks for the country as far as official international dialogue is
concerned. This is also particularly important to cases where zoning and regionalisation are being
applied. The responsibilities of the national Veterinary Administration and all Veterinary Authorities in
that country should be made clear in the process of evaluation of Veterinary Services.
6. A Veterinary Authority is defined in Chapter 1.1.1. of this Terrestrial Code. As some countries have
some official Veterinary Authority roles vested in autonomous sub-national (state/provincial,
municipal) government bodies, there is an important need to assess the role and function of these
Services. Details of their roles, relationship (legal and administrative) to each other and to the
national Veterinary Services should be available for evaluation. Annual reports, review findings and
access to other information pertinent to the animal health activities of such bodies should also be
available.
7. Similarly, where the national Veterinary Services have arrangements with other providers of relevant
services such as universities, laboratories, information services, etc., these arrangements should also
be described. For the purposes of evaluation, it is appropriate to expect that the quality of
organisational and functional standards which apply to Veterinary Services should also apply to the
services of these other providers.
Article 1.3.4.4.
1. The Veterinary Services should demonstrate a commitment to the quality of the processes and outputs
of their services. Where services or components of services are delivered under a formal quality
systems programme which is based on OIE recommended standards or, especially in the case of
laboratory components of Veterinary Services other internationally recognised quality standards, the
Veterinary Services undergoing evaluation should make available evidence of accreditation, details of
the documented quality processes and documented outcomes of all relevant audits undertaken.
2. Where the Veterinary Services undergoing evaluation make large use of formal quality systems in the
delivery of their services, it is appropriate that greater emphasis be placed on the outcomes of
evaluation of these quality systems than on the resource and infrastructural components of the
services.
Article 1.3.4.5.
1. The Veterinary Services should demonstrate that their human resource component includes an integral
core of full-time civil service employees. This core must include veterinarians. It should also include
administrative officials and veterinary para-professionals. The human resources may also include
part-time and private sector veterinarians and veterinary para-professionals. It is essential that all the
above categories of personnel be subject to legal disciplinary provisions. Data relating to the resource
base of the Veterinary Services undergoing evaluation should be available.
2. In addition to raw quantitative data on this resource base, the functions of the various categories of
personnel in the Veterinary Services should be described in detail. This is necessary for analysis and
estimation of the appropriateness of the application of qualified skills to the tasks undertaken by the
Veterinary Services and may be relevant, for example, to the roles of veterinarians and veterinary
para-professionals in field services. In this case, the evaluation should provide assurances that disease
monitoring is being conducted by a sufficient number of qualified, experienced field veterinarians
who are directly involved in farm visits; there should not be an over-reliance on veterinary
para-professionals for this task.
3. Analysis of these data can be used to estimate the potential of the Veterinary Services to have reliable
knowledge of the state of animal health in the country and to support an optimal level of animal
disease control programmes. A large population of private veterinarians would not provide the
Veterinary Services with an effective epizootiological information base without legislative (e.g.
compulsory reporting of notifiable diseases) and administrative (e.g. official animal health
surveillance and reporting systems) mechanisms in place.
4. These data should be assessed in close conjunction with the other information described in this
Chapter. For example, a large field staff (veterinarians and veterinary para-professionals) need fixed,
mobile and budgetary resources for animal health activities in the livestock farming territory of the
country. If deficiencies are evident, there would be reason to challenge the validity of epizootiological
information.
Article 1.3.4.6.
1. Financial
Actual yearly budgetary information regarding the Veterinary Services should be available and should
include the details set out in the model questionnaire outlined in Article 1.3.4.14. Information is
required on conditions of service for veterinary staff (including salaries and incentives) and should
provide a comparison with the private sector and perhaps with other professionals. Information
should also be available on non-government sources of revenue available to veterinarians in their
official responsibilities.
2. Administrative
a) Accommodation
The Veterinary Services should be accommodated in premises suitable for efficient performance
of their functions. The component parts of the Veterinary Services should be located as closely as
possible to each other at the central level, and in the regions where they are represented, in
order to facilitate efficient internal communication and function.
b) Communications
The Veterinary Services should be able to demonstrate that they have reliable access to effective
communications systems, especially for animal health surveillance and control programmes.
Inadequate communications systems within the field services components of these programmes
or between outlying offices and headquarters, or between the Veterinary Services and other
relevant administrative and professional services, signify an inherent weakness in these
programmes. Adequate communications systems between laboratories and between field and
laboratory components of the Veterinary Services should also be demonstrated.
Examples of types of communications which should be routinely available on an adequate
country-wide basis are national postal, freight and telephone networks. Rapid courier services,
facsimile and electronic data interchange systems (e.g. e-mail and Internet services) are examples
of useful communication services which, if available, can supplement or replace the others. A
means for rapid international communication should be available to the national Veterinary
Services, to permit reporting of changes in national disease status consistent with OIE
recommendations and to allow bilateral contact on urgent matters with counterpart Veterinary
Services in trading-partner countries.
c) Transport systems
The availability of sufficient reliable transport facilities is essential for the performance of many
functions of Veterinary Services. This applies particularly to the field services components of
animal health activities (e.g. emergency response visits). Otherwise, the Veterinary Services cannot
assure counterpart services in other countries that they are in control of the animal health
situation within the country.
Appropriate means of transport are also vital for the satisfactory receipt of samples to be tested
at veterinary laboratories, for inspection of imports and exports, and for the performance of
animals and animal product inspection in outlying production or processing establishments.
3. Technical
Details available on laboratories should include resources data, programmes under way as well as
those recently completed and review reports on the role or functions of the laboratory. Information
as described in the model questionnaire should be used in the evaluation of laboratory services.
a) Cold chain for laboratory samples and veterinary medicines
Adequate refrigeration and freezing systems should be available and should be used throughout
the country to provide suitable low temperature protection for laboratory samples in transit or
awaiting analysis, as well as veterinary medical products (e.g. vaccines) when these are required
for use in animal disease control programmes. If these assurances cannot be given, it may be
valid to discount many types of test results, as well as the effectiveness of certain disease control
programmes and the export inspection system in the country undergoing evaluation.
b) Diagnostic laboratories
Analysis of the laboratory service component of Veterinary Services, which would include official
governmental laboratories and other laboratories accredited by the Veterinary Services for
specified purposes, is an essential element of the evaluation process. The quality of the
veterinary diagnostic laboratories of a country underpins the whole control and certification
processes of the zoosanitary/sanitary status of exported animals and animal products, and
therefore these laboratories should be subject to rigid quality assurance procedures and should
use international quality assurance programmes (wherever available) for standardising test
methodologies and testing proficiency. An example is the use of International Standard Sera for
standardising reagents.
This emphasis is valid whether one relates it to the actual testing performed on individual
export consignments or to the more broad and ongoing testing regimes which are used to
determine the animal health and veterinary public health profiles of the country and to support
its disease control programmes. For the purposes of evaluation, veterinary diagnostic
laboratories include those which are concerned with either animal health or veterinary public
health activities. The Veterinary Services must approve and designate these laboratories for such
purposes and have them audited regularly.
c) Research
The scope of animal disease and veterinary public health problems in the country concerned,
the stages reached in the controls which address those problems and their relative importance
can be measured to some degree by analysis of information on government priorities and
programmes for research in animal health. This information should be accessible for evaluation
purposes.
Article 1.3.4.7.
officials and by private individuals or corporations. The certifying veterinarian should have no
conflict of interest in the commercial aspects of the animals or animal product being certified and be
independent from the commercial parties.
Article 1.3.4.8.
Article 1.3.4.9.
1. Food hygiene
The national Veterinary Services should be able to demonstrate effective responsibility for the
veterinary public health programmes relating to the production and processing of animal products. If
the national Veterinary Services do not exercise responsibility over these programmes, the evaluation
should include a comprehensive review of the role and relationship of the organisations (national,
state/provincial, and municipal) which are involved. In such a case, the evaluation should consider
whether the national Veterinary Services can provide guarantees of responsibility for an effective
control of the sanitary status of animal products throughout the slaughter, processing, transport and
storage periods.
2. Zoonoses
Within the structure of Veterinary Services, there should be appropriately qualified personnel whose
responsibilities include the monitoring and control of zoonotic diseases and, where appropriate,
liaison with medical authorities.
Adequacy of controls over chemical residues in exported animals, animal products and feedstuffs
should be demonstrated. Statistically-based surveillance and monitoring programmes for
environmental and other chemical contaminants in animals, in animal-derived foodstuffs and in
animal feedstuffs should be favourably noted. These programmes should be coordinated nationwide.
Correlated results should be freely available on request to existing and prospective trading partner
countries. Analytical methods and result reporting should be consistent with internationally
recognised standards. If official responsibility for these programmes does not rest with the Veterinary
Services, there should be appropriate provision to ensure that the results of such programmes are
made available to the Veterinary Services for assessment.
4. Veterinary medicines
It should be acknowledged that primary control over veterinary medicinal products may not rest with
the Veterinary Authorities in some countries, owing to differences between governments in the
division of legislative responsibilities. However, for the purpose of evaluation, the Veterinary Services
should be able to demonstrate the existence of effective controls (including nationwide consistency
of application) over the manufacture, importation, export, registration, supply, sale and use of
veterinary medicines, biologicals and diagnostic reagents, whatever their origin. The control of
veterinary medicines has direct relevance to the areas of animal health and public health.
In the animal health sphere, this has particular application to biological products. Inadequate
controls on the registration and use of biological products leave the Veterinary Services open to
challenge over the quality of animal disease control programmes and over safeguards against animal
disease introduction in imported veterinary biological products.
It is valid, for evaluation purposes, to seek assurances of effective government controls over
veterinary medicines in so far as these relate to the public health risks associated with residues of
these chemicals in animals and animal-derived foodstuffs. This process should be consistent with the
standards set by the Codex Alimentarius or with alternative requirements set by the importing country
where the latter are scientifically justified.
The existence of any organised programme which incorporates a structured system of information
feedback from inspection in establishments producing products of animal origin, in particular meat
or dairy products, and applies this in animal health control should be favourably noted. Such
programmes should be integrated within a national disease surveillance scheme.
Veterinary Services which direct a significant element of their animal health programmes specifically
towards minimising microbial and chemical contamination of animal-derived products in the human
food chain should receive favourable recognition in the evaluation. There should be evident linkage
between these programmes and the official control of veterinary medicines and relevant agricultural
chemicals.
Article 1.3.4.10.
1. Strategic plans
The objectives and priorities of the Veterinary Services can be well evaluated if there is a published
official strategic plan which is regularly updated. Understanding of functional activities is enhanced if
an operational plan is maintained within the context of the strategic plan. The strategic and
operational plans, if these exist, should be included in the evaluation.
Veterinary Services which use strategic and operational plans may be better able to demonstrate
effective management than countries without such plans.
2. Performance assessment
If a strategic plan is used, it is desirable to have a process which allows the organisation to assess its
own performance against its objectives. Performance indicators and the outcomes of any review to
measure achievements against pre-determined performance indicators should be available for
evaluation. The results should be considered in the evaluation process.
3. Compliance
Matters which can compromise compliance and adversely affect a favourable evaluation include
instances of inaccurate or misleading official certification, evidence of fraud, corruption, or
interference by higher political levels in international veterinary certification, and lack of resources
and poor infrastructure.
It is desirable that the Veterinary Services contain (or have a formal linkage with) an independent
internal unit/section/commission the function of which is to critically scrutinise their operations.
The aim of this unit should be to ensure consistent and high integrity in the work of the individual
officials in the Veterinary Services and of the corporate body itself. The existence of such a body can
be important to the establishment of international confidence in the Veterinary Services.
An important feature when demonstrating the integrity of the Veterinary Services is their ability to
take corrective action when miscertification, fraud or corruption has occurred.
A supplementary or an alternative process for setting performance standards and application of
monitoring and audit is the implementation of formal quality systems to some or all activities for
which the Veterinary Services are responsible. Formal accreditation to international quality system
standards should be utilised if recognition in the evaluation process is to be sought.
4. Veterinary Services administration
a) Annual reports
Official government annual reports should be published, which provide information on the
organisation and structure, budget, activities and contemporary performance of the Veterinary
Services. Current and retrospective copies of such reports should be available to counterpart
Services in other countries, especially trade partners.
b) Reports of government review bodies
The reports of any periodic or ad hoc government reviews of Veterinary Services or of particular
functions or roles of the Veterinary Services should be considered in the evaluation process.
Details of action taken as a consequence of the review should also be accessible.
c) Reports of special committees of enquiry or independent review bodies
Recent reports on the Veterinary Services or elements of their role or function, and details of any
subsequent implementation of recommendations contained in these reports should be available.
The Veterinary Services concerned should recognise that the provision of such information need
not be detrimental to the evaluation outcome; in fact, it may demonstrate evidence of an
effective audit and response programme. The supplying of such information can reinforce a
commitment to transparency.
d) In-service training and development programme for staff
In order to maintain a progressive approach to meeting the needs and challenges of the
changing domestic and international role of Veterinary Services, the national administration
should have in place an organised programme which provides appropriate training across a
range of subjects for relevant staff. This programme should include participation in scientific
meetings of animal health organisations. Such a programme should be used in assessing the
effectiveness of the Services.
e) Publications
Veterinary Services can augment their reputation by demonstrating that their staff publish
scientific articles in refereed veterinary journals or other publications.
f) Formal linkages with sources of independent scientific expertise
Details of formal consultation or advisory mechanisms in place and operating between the
Veterinary Services and local and international universities, scientific institutions or recognised
veterinary organisations should be taken into consideration. These could serve to enhance the
international recognition of the Veterinary Services.
g) Trade performance history
In the evaluation of the Veterinary Services of a country, it is pertinent to examine the recent
history of their performance and integrity in trade dealings with other countries. Sources of
such historical data may include Customs Services.
Article 1.3.4.11.
Questions on a country's adherence to its obligations as a member of the OIE are relevant to an
evaluation of the Veterinary Services of the country. Self-acknowledged inability or repeated failure of a
Member Country to fulfil reporting obligations to the OIE will detract from the overall outcome of the
evaluation. Such countries, as well as non-member countries, will need to provide extensive information
regarding their Veterinary Services and sanitary/zoosanitary status for evaluation purposes.
Article 1.3.4.12.
In the evaluation of the Veterinary statutory body, the following items may be considered, depending on the
purpose of the evaluation:
- human resources, including the composition and representation of the body's membership;
- institutional arrangements, accountability and transparency of decision-making;
- sources and management of funding;
- functional capabilities, including the ability to enforce its decisions (for example regarding
registration requirements, standards of conduct, and disciplinary procedures);
- administration of continuing professional development and education programmes for veterinarians
and veterinary para-professionals;
- legislative basis, including autonomy.
Article 1.3.4.13.
1. The Veterinary Services of a country may undertake self-evaluation against the above criteria for such
purposes as national interest, improvement of internal efficiency or export trade facilitation. The way
in which the results of self-evaluation are used or distributed is a matter for the country concerned.
2. A prospective importing country may undertake an evaluation of the Veterinary Services of an exporting
country as part of a risk analysis process, which is necessary to determine the sanitary or zoosanitary
measures which the country will use to protect human or animal life or health from disease or pest
threats posed by imports. Periodic evaluation reviews are also valid following the commencement of
trade.
3. In the case of evaluation for the purposes of international trade, the authorities of an importing country
should use the principles elaborated above as the basis for the evaluation and should attempt to
acquire information according to the model questionnaire outlined in Article 1.3.4.14. The Veterinary
Services of the importing country are responsible for the analysis of details and for determining the
outcome of the evaluation after taking into account all the relevant information. The relative ranking
of importance ascribed, in the evaluation, to the criteria described in this Chapter will necessarily vary
according to case-by-case circumstances. This ranking should be established in an objective and
justifiable way. Analysis of the information obtained in the course of an evaluation study must be
performed in as objective a manner as possible. The validity of the information should be established
and reasonableness should be employed in its application. The assessing country must be willing to
defend any position taken on the basis of this type of information, if challenged by the other party.
Article 1.3.4.14.
This Article outlines appropriate information requirements for the self-evaluation or evaluation of the
Veterinary Services of a country.
1. Organisation and structure of Veterinary Services
a) National Veterinary Services
Organisational chart including numbers, positions and numbers of vacancies.
b) Sub-national Veterinary Services
Organisational charts including numbers, positions and number of vacancies.
c) Other providers of Veterinary Services
Description of any linkage with other providers of Veterinary Services.
2. National information on human resources
a) Veterinarians
i) Total numbers of veterinarians registered/licensed by the Veterinary statutory body of the
country:
ii) Numbers of:
- full time government veterinarians: national and sub-national;
- part time government veterinarians: national and sub-national;
- private veterinarians authorised by the Veterinary Services to perform official veterinary
functions; [Describe accreditation standards, responsibilities and/or limitations applying to
these private veterinarians.]
- other veterinarians.
- Education/training details.
d) Support personnel
Numbers directly available to Veterinary Services per sector (administration, communication,
transport).
e) Descriptive summary of the functions of the various categories of staff mentioned above
f) Veterinary, veterinary para-professionals, livestock owner, farmer and other relevant associations
g) Additional information and/or comments.
3. Financial management information
a) Total budgetary allocations to the Veterinary Services for the current and past two fiscal years:
i) for the national Veterinary Services;
ii) for each of any sub-national veterinary authorities;
iii) for other relevant government-funded institutions.
b) Sources of the budgetary allocations and amount:
i) government budget;
ii) sub-national authorities;
iii) taxes and fines;
iv) grants;
v) private services.
c) Proportional allocations of the amounts in a) above for operational activities and for the
programme components of Veterinary Services.
d) Total allocation proportionate of national public sector budget. [This data may be necessary for
comparative assessment with other countries which should take into account the contexts of the importance
of the livestock sector to the national economy and of the animal health status of the country.]
e) Actual and proportional contribution of animal production to gross domestic product.
4. Administration details
a) Accommodation
Summary of the numbers and distribution of official administrative centres of the Veterinary
Services (national and sub-national) in the country.
b) Communications
Summary of the forms of communication systems available to the Veterinary Services on a
nation-wide and local area bases.
c) Transport
i) Itemised numbers of types of functional transport available on a full-time basis for the
Veterinary Services. In addition provide details of transport means available part-time.
ii) Details of annual funds available for maintenance and replacement of motor vehicles.
5. Laboratory services
a) Diagnostic laboratories (laboratories engaged primarily in diagnosis)
i) Descriptive summary of the organisational structure and role of the government veterinary
laboratory service in particular its relevance to the field Veterinary Services.
ii) Numbers of veterinary diagnostic laboratories operating in the country:
- government operated laboratories;
- Descriptive summary of the analytical methodologies used and their consistency with
internationally recognised standards.
iv) Veterinary medicines
- Descriptive summary of the administrative and technical controls involving
registration, supply and use of veterinary pharmaceutical products especially including
biological products. This summary should include a focus on veterinary public health
considerations relating to the use of these products in food-producing animals.
- Role and function in these programmes of the national Veterinary Services and other
Veterinary Services to be described in summary form.
8. Quality systems
a) Accreditation
Details and evidence of any current, formal accreditation by external agencies of the Veterinary
Services of any components thereof.
b) Quality manuals
Documented details of the quality manuals and standards which describe the accredited quality
systems of the Veterinary Services.
c) Audit
Details of independent (and internal) audit reports which have been undertaken of the
Veterinary Services of components thereof.
9. Performance assessment and audit programmes
a) Strategic plans and review
i) Descriptive summary and copies of strategic and operational plans of the Veterinary Services
organisation.
ii) Descriptive summary of corporate performance assessment programmes which relate to
the strategic and operational plans - copies of recent review reports.
b) Compliance
Descriptive summary of any compliance unit which monitors the work of the Veterinary Services
(or elements thereof).
c) Annual reports of the national Veterinary Services
Copies of official annual reports of the national (sub-national) Veterinary Services.
d) Other reports
i) Copies of reports of official reviews into the function or role of the Veterinary Services
which have been conducted within the past three years.
ii) Descriptive summary (and copy of reports if available) of subsequent action taken on
recommendations made in these reviews.
e) Training
i) Descriptive summary of in-service and development programmes provided by the
Veterinary Services (or their parent Ministries) for relevant staff.
ii) Summary descriptions of training courses and duration.
iii) Details of staff numbers (and their function) who participated in these training courses in
the last three years.
f) Publications
Bibliographical list of scientific publications by staff members of Veterinary Services in the past
three years.
g) Sources of independent scientific expertise
List of local and international universities, scientific institutions and recognised veterinary
organisations with which the Veterinary Services have consultation or advisory mechanisms in
place.
10. Membership of the OIE
State if country is a member of the OIE and period of membership.
11. Other assessment criteria
Article 1.3.5.1.
Introduction
For the purposes of this Terrestrial Code, ‘zoning’ and ‘regionalisation’ have the same meaning.
Given the difficulty of establishing and maintaining a disease free status for an entire country, especially
for diseases the entry of which is difficult to control through measures at national boundaries, there may
be benefits to Member Countries in establishing and maintaining a subpopulation with a different animal
health status within national boundaries. Subpopulations may be separated by natural or artificial
geographical barriers, or in certain animal industries, by the application of appropriate management
systems, including biosecurity management.
Zoning and compartmentalisation are procedures implemented by a country under the provisions of this
Chapter with a view to defining subpopulations of different animal health status within its territory for the
purpose of disease control and/or international trade. Compartmentalisation applies to a subpopulation when
management systems related to biosecurity are applied, while zoning applies when a subpopulation is
defined on a geographical basis.
This Chapter is to assist OIE Member Countries to establish and maintain different subpopulations within
their national boundaries using the procedures of compartmentalisation and zoning. It also outlines a
process for trading partners to follow in achieving recognition of such subpopulation. These procedures are
best implemented by trading partners through establishing parameters and gaining agreement on the
necessary measures prior to disease outbreaks.
Separate requirements will be developed for each disease for which the application of zoning or
compartmentalisation is considered appropriate.
Article 1.3.5.2.
General considerations
Before trade in animals or their products may occur, an importing country needs to be satisfied that its
animal health status will be appropriately protected. In most cases, the import regulations developed will
rely in part on judgements made about the effectiveness of sanitary procedures undertaken by the
exporting country, both at its boundaries and within its territory.
The benefits of zoning and compartmentalisation may include a contribution to disease control or
eradication within Member Countries, and to the safety of international trade. Zoning may encourage the
more efficient use of resources within certain parts of a country to allow trade in certain commodities from
that zone in accordance with this Terrestrial Code. Compartmentalisation may allow safe trade due to the
functional separation of a subpopulation from other domestic or wild animals through biosecurity
measures, which a zone (through geographical separation alone) would not achieve. Following a disease
outbreak, compartmentalisation may be able to take advantage of epidemiological linkages despite diverse
geographical locations, to facilitate disease control.
The Veterinary Services of an exporting country which is establishing a zone or compartment within its territory
for international trade purposes should clearly define the subpopulation in accordance with the measures
stipulated in the relevant Chapters in this Terrestrial Code and should be able to explain to the Veterinary
Services of an importing country the basis for its claim of a distinct animal health status for the zone or
compartment in such terms.
The procedures used to establish and maintain the distinct health status of a zone or compartment should be
appropriate to the particular circumstances, and will depend on the epidemiology of the disease,
environmental factors, applicable biosecurity measures (including movement controls, use of natural and
artificial boundaries, commercial management and husbandry practices), and surveillance and monitoring.
The exporting country should be able to demonstrate, through detailed documentation published through
official channels, that it has implemented the measures stipulated in this Terrestrial Code for establishing
and maintaining such a zone or compartment.
An importing country should recognise the existence of this zone or compartment when the appropriate
measures recommended in this Terrestrial Code are applied.
Article 1.3.5.3.
The exporting country should conduct a practical assessment of the resources needed and available to
establish and maintain a zone or compartment for international trade purposes. These include the human and
financial resources, and the technical capability of the Veterinary Services (and of the relevant industry, in
the case of a compartment).
Article 1.3.5.4.
In conjunction with the above considerations, defining a zone or compartment should be based on the
application of the following principles.
1. The extent of a zone and its limits should be established by the Veterinary Administration on the basis
of natural, artificial or legal boundaries, and made public through official channels.
3. Animals and herds belonging to subpopulations need to be clearly recognizable as such. The Veterinary
Administration must document in detail the measures taken to ensure the identification of the
subpopulation and the recognition and maintenance of its health status.
4. The requirements necessary to preserve the distinct health status of a zone or compartment must be
appropriate to the particular disease and will depend on the epidemiology of the disease,
environmental factors, biosecurity management, animal husbandry practices, control measures and
surveillance.
5. Thus defined, the zones and compartments constitute the relevant subpopulations for the application of
the recommendations in Part 2 of this Terrestrial Code.
Article 1.3.5.5.
There is no single sequence of steps which must be followed in defining a zone or a compartment. The steps
that the Veterinary Services of the importing country and the exporting country choose and implement will
generally depend on the circumstances existing within a country and at its borders. The recommended
steps are:
1. For zoning
a) The exporting country identifies a geographical area within its territory which it considers to
contain an animal subpopulation with a distinct health status with respect to a specific
disease/specific diseases, based on surveillance and monitoring.
b) The exporting country identifies the procedures which are being, or could be, employed to
distinguish such an area epidemiologically from other parts of its territory, in accordance with
the measures stipulated in this Terrestrial Code.
c) The exporting country provides the information above to the importing country, and explains that
the area can be treated as an epidemiologically separated zone for international trade purposes.
d) The importing country determines whether it may accept such an area as a zone for the
importation of animals and animal products, taking into account:
i) an evaluation of the exporting country's Veterinary Services;
ii) the result of a risk assessment based on the information provided by the exporting country and
its own research;
iii) its own animal health situation with respect to the disease(s) concerned; and
iv) other relevant OIE standards.
e) The importing country notifies the exporting country of the result of its determination and the
underlying reasons, within a reasonable period of time, being either:
i) recognition of the zone;
ii) request for further information; or
iii) rejection of the area as a zone for international trade purposes.
f) An attempt should be made to resolve any differences of opinion over the definition of the
zone, either in the interim or finally, by using an agreed mechanism to reach consensus (such as
the OIE dispute settlement mechanism).
g) The importing country and the exporting country may enter into a formal agreement defining the
zone.
2. For compartmentalisation
a) Based on discussions with the relevant enterprise/industry, the exporting country identifies within
its territory one or more establishments or other premises owned by an enterprise(s) which
operates under a common biosecurity management system, and which it considers contains an
identifiable animal subpopulation with a distinct health status with respect to a specific
disease/specific diseases; and that this status is maintained through a partnership between the
relevant enterprise/industry and the Veterinary Services of the exporting country.
b) The exporting country examines the ‘biosecurity management manual’ produced by the
enterprise/industry for such establishment(s), and confirms through an audit that:
i) such establishment(s) is(are) epidemiologically closed throughout its routine operating
procedures as a result of effective implementation of its ‘biosecurity management manual’;
and
ii) the surveillance and monitoring programme in place is appropriate to verify the free status
of such establishment(s) with respect to such disease(s).
c) The exporting country identifies such an enterprise to be a free compartment, in accordance with the
measures stipulated in this Terrestrial Code.
d) The exporting country provides the information above to the importing country, and explains that
such an enterprise can be treated as an epidemiologically separated compartment for international
trade purposes.
e) The importing country determines whether it may accept such an enterprise as a compartment
taking into account:
i) an evaluation of the exporting country's Veterinary Services;
ii) the result of a risk assessment based on the information provided by the exporting country and
its own research;
iii) its own animal health situation with respect to the disease(s) concerned; and
iv) other relevant OIE standards.
f) The importing country notifies the exporting country of the result of its examination and the
underlying reasons, within a reasonable period of time, being either:
i) recognition of the compartment;
ii) request for further information; or
iii) rejection of such an enterprise as a compartment for international trade purposes.
g) An attempt should be made to resolve any differences of opinion over the definition of the
compartment, either in the interim or finally, by using an agreed mechanism to reach consensus
(such as the OIE dispute settlement mechanism).
h) The importing country and the exporting country may enter into a formal agreement defining the
compartment.
Article 1.3.6.1.
Introduction
The importation of animals and animal products involves a degree of risk to the animal health status of an
importing country. The estimation of that risk and the choice of the appropriate risk management option(s)
are made more difficult by differences among the animal health and production systems in OIE Member
Countries. It is now recognised that significantly different animal health and production systems can
provide equivalent animal and human health protection for the purpose of international trade, with benefits
to both the importing country and the exporting country.
These guidelines are to assist OIE Member Countries to determine whether sanitary measures arising from
different animal health and production systems may provide the same level of animal and human health
protection. They discuss principles which might be utilised in a judgement of equivalence, and outline a
step-wise process for trading partners to follow in facilitating a judgement of equivalence. These
guidelines are applicable whether equivalence applies at the level of specific measures or on a
systems-wide basis, and whether equivalence applies to specific areas of trade or commodities, or generally.
Article 1.3.6.2.
General considerations
Before trade in animals or their products may occur, an importing country must be satisfied that its animal
health status will be appropriately protected. In most cases, the risk management measures drawn up will rely
in part on judgements made about the animal health and production system(s) in the exporting country and
the effectiveness of sanitary procedures undertaken there. Systems operating in the exporting country may
differ from those in the importing country and from those in other countries with which the importing
country has traded. Differences may be with respect to infrastructure, policies and/or operating
procedures, laboratory systems, approaches to the pests and diseases present, border security and internal
movement controls.
International recognition of the legitimacy of different approaches to achieving the importing country's
appropriate level of protection (ALOP) has led to the principle of equivalence being included in trade
agreements, including the Agreement on Application of Sanitary and Phytosanitary Measures (the SPS
Agreement) of the World Trade Organization (WTO).
Benefits of applying equivalence may include:
1. minimising costs associated with international trade by tailoring animal health measures to local
circumstances;
2. maximising animal health outcomes for a given level of resource input;
3. facilitating trade by achieving the required health protection through less trade restrictive sanitary
measures; and
4. decreased reliance on relatively costly commodity testing and isolation procedures in bilateral or
multilateral agreements.
The Terrestrial Code recognises equivalence by recommending alternative sanitary measures for many diseases
and pathogenic agents. Equivalence may be gained, for example, by enhanced surveillance and
monitoring, by the use of alternative test, treatment or isolation procedures, or by combinations of the
above. To facilitate the judgement of equivalence, Member Countries should base their sanitary measures
on OIE standards, guidelines and recommendations.
It is essential to apply a scientific risk analysis to the extent practicable in establishing the basis for a
judgement of equivalence.
Article 1.3.6.3.
requirement level may require that the specific measure be judged in its context through examination
of infrastructure and programmes.
Article 1.3.6.4.
In conjunction with the above considerations, judgement of the equivalence of sanitary measures should be
based on application of the following principles:
1. an importing country has the right to set the level of protection it deems appropriate (its ALOP) in
relation to human and animal life and health in its territory; this ALOP may be expressed in
qualitative or quantitative terms;
2. the importing country should be able to describe the reason for each sanitary measure i.e. the level of
protection intended to be achieved by application of the identified measure against a hazard;
3. an importing country should recognise that sanitary measures different from the ones it has proposed
may be capable of providing the same level of protection;
4. the importing country should, upon request, enter into consultations with the exporting country with the
aim of facilitating a judgement of equivalence;
5. any sanitary measure or combination of sanitary measures can be proposed for judgement of
equivalence;
6. an interactive process should be followed that applies a defined sequence of steps, and utilises an
agreed process for exchange of information, so as to limit data collection to that which is necessary,
minimise administrative burden, and facilitate resolution of claims;
7. the exporting country should be able to demonstrate objectively how the alternative sanitary measure(s)
proposed as equivalent will provide the same level of protection;
8. the exporting country should present a submission for equivalence in a form that facilitates judgement
by the importing country;
9. the importing country should evaluate submissions for equivalence in a timely, consistent, transparent
and objective manner, and according to appropriate risk assessment principles;
10. the importing country should take into account any knowledge of and prior experience with the
Veterinary Administration or other Competent Authority of the exporting country;
11. the exporting country should provide access to enable the procedures or systems which are the subject
of the equivalence judgement to be examined and evaluated upon request of the importing country;
12. the importing country should be the sole determinant of equivalence, but should provide to the
exporting country a full explanation for its judgement;
13. to facilitate a judgement of equivalence, Member Countries should base their sanitary measures on
relevant OIE standards;
14. to allow the judgement of equivalence to be reassessed if necessary, the importing country and the
exporting country should keep each other informed of significant changes to infrastructure, health
status or programmes which may bear on the judgement of equivalence; and
15. an importing country should give positive consideration to a request by an exporting developing
country for appropriate technical assistance that would facilitate the successful completion of a
judgement of equivalence.
Article 1.3.6.5.
There is no single sequence of steps which must be followed in all judgements of equivalence. The steps
that trading partners choose will generally depend on the circumstances and their trading experience. The
interactive sequence of steps described below may be useful for all sanitary measures irrespective of their
categorisation as infrastructure, programme design/implementation or specific technical requirement
components of an animal health and production system.
This sequence assumes that the importing country is meeting its obligations under the WTO SPS Agreement
and has in place a transparent measure based either on an international standard or a risk analysis.
1. the exporting country identifies the measure(s) for which it wishes to propose an alternative
measure(s), and requests from the importing country a reason for its sanitary measure in terms of the
level of protection intended to be achieved against a hazard(s);
2. the importing country explains the reason for the measure(s), in terms which would facilitate
comparison with an alternative sanitary measure(s) and consistent with the principles set out in these
guidelines;
3. the exporting country demonstrates the case for equivalence of an alternative sanitary measure(s) in a
form which facilitates analysis by an importing country;
4. the exporting country responds to any technical concerns raised by the importing country by providing
relevant further information;
b) the expected effect of the alternative sanitary measure(s) on all relevant hazards;
c) OIE standards;
6. the importing country notifies the exporting country of its judgement and the underlying reasons within a
reasonable period of time:
7. an attempt should be made to resolve any differences of opinion over judgement of a case, either
interim or final, by using an agreed mechanism to reach consensus (e.g. the OIE dispute settlement
mechanism), or by referral to an agreed expert;
8. depending on the category of measures involved, the importing country and the exporting country may
enter into a formal equivalence agreement giving effect to the judgement or a less formal
acknowledgement of the equivalence of a specific measure(s) may suffice.
An importing country recognising the equivalence of an exporting country's alternative sanitary measure(s) needs
to ensure that it acts consistently with regard to applications from third countries for recognition of
equivalence applying to the same or very similar measure(s). Consistent action does not mean however
that a specific measure(s) proposed by several exporting countries should always be judged as equivalent as
a measure(s) should not be considered in isolation but as part of a system of infrastructure, policies and
procedures.
IMPORT/EXPORT PROCEDURES
CHAPTER 1.4.1.
Article 1.4.1.1.
1. Countries should only authorise the exportation from their territory of animals for breeding, rearing or
slaughter which are correctly identified and which meet the requirements of the importing country.
2. Biological tests and/or vaccinations required by the importing country should be carried out in
accordance with the recommendations in the Terrestrial Code and Terrestrial Manual, as well as
disinfection and disinfestation procedures.
3. Observation of the animals before leaving the country may be carried out either in the establishment
where they were reared, or in a quarantine station. When they have been found to be clinically healthy
and free from diseases listed by the OIE by an Official Veterinarian during the period of observation,
the animals should be transported to the place of shipment in specially constructed vehicles, previously
cleansed and disinfected. This must be done without delay and without the animals coming into
contact with other susceptible animals, unless these animals have animal health guarantees similar to
those of the transported animals.
4. The transportation of the animals for breeding or rearing or animals for slaughter from the establishment
of origin to the point of departure from the exporting country shall be carried out in conformity with
the conditions agreed between the importing country and exporting country.
Article 1.4.1.2.
Countries should only undertake the export from its territory of:
a) semen,
b) embryos/ova,
c) hatching eggs,
from artificial insemination centres, collection centres or farms which meet the requirements of the importing
country.
Article 1.4.1.3.
Countries exporting animals, semen, embryos/ova or hatching eggs should inform the country of
destination and where necessary the transit countries if, after exportation, a disease listed by the OIE occurs
within the incubation period of that particular disease, in the establishment of origin, or in an animal which
was in a collecting centre, or in a market, at the same time as the exported animals.
Article 1.4.1.4.
Before the departure of animals, semen, embryos/ova, hatching eggs and brood-combs of bees, an Official
Veterinarian should, within the 24 hours prior to shipment, provide an international veterinary certificate
conforming with the models approved by the OIE (as shown in Part 4 of this Terrestrial Code) and
worded in the languages agreed upon between the exporting country and the importing country, and, where
necessary, with the transit countries.
Article 1.4.1.5.
2. The Veterinary Authority referred to in point 1 above shall take necessary measures to:
a) prevent the shipment of animals affected or suspected of being affected with any disease listed
by the OIE or with any other infectious disease;
b) avoid entry into the vehicle of possible vectors or causal agents of infection.
Article 1.4.1.6.
1. Countries should only authorise the export from their territory of meat and products of animal origin
intended for human consumption, which are fit for human consumption. They must be
accompanied by an international veterinary certificate conforming with the models approved by the OIE
(as shown in Part 4. of this Terrestrial Code). These must be worded in the languages agreed upon
between the exporting country and the importing country, and, where necessary, with the transit countries.
2. Products of animal origin intended for use in animal feeding, or for pharmaceutical or surgical or
agricultural or industrial use, should be accompanied by an international veterinary certificate
conforming with the models approved by the OIE (as shown in Part 4. of this Terrestrial Code).
Article 1.4.2.1.
1. Any country through which the transit of animals is required, and which normally conducts
commercial transactions with the exporting country, should not refuse transit, subject to the
reservations mentioned below and on condition that advance notice is given of the proposed transit
to the Veterinary Administration and Veterinary Authority in charge of border posts.
This advance notice shall state the species and number of animals, the methods of transport and the
border posts of entry and exit in accordance with a previously arranged and authorised itinerary in the
transit country.
2. Any country through which transit is to take place may refuse if it considers that certain diseases
exist in the exporting country, or in a transit country which precedes it in the itinerary, which are capable
of being transmitted to its own animals.
3. Any transit country may require the presentation of international veterinary certificates. Such a country
may, in addition, cause an examination to be made by an Official Veterinarian of the health status of
animals in transit, except in cases where transport in sealed vehicles or containers is a condition of
transit.
4. Any transit country may refuse passage through its territory of animals presented at one of its border
posts if an examination carried out by an Official Veterinarian shows that the animal or consignment of
animals in transit is affected by or infected with any of the notifiable epizootic diseases, or if the
international veterinary certificate is inaccurate and/or unsigned.
In these circumstances, the Veterinary Administration of the exporting country shall be informed
immediately, thereby providing an opportunity for checking the findings or correcting the certificate.
If the diagnosis of an epizootic disease is confirmed, or if the certificate cannot be corrected, the
animal or consignment of animals in transit shall either be returned to the exporting country or be
slaughtered or destroyed.
5. This Article does not apply to bees that are transported in securely closed vehicles or containers.
Article 1.4.2.2.
1. Any transit country may require railway wagons and road vehicles used for the transit of animals
through its territory to be so constructed as to prevent the escape and dispersion of excrement.
2. The unloading of animals in transit shall be permitted in the territory of the transit country only for
purposes of watering and feeding or for welfare or other essential reasons. This must be under the
effective control of an Official Veterinarian of the transit country, who should ensure that the animals
have no contact with any other animals. The importing country shall be informed of any unforeseen
unloading in the transit country.
Article 1.4.2.3.
Article 1.4.2.4.
Vessels stopping in a port or passing through a canal or other navigable waterway situated in the territory
of a country, on their way to a port situated in the territory of another country, must comply with the
conditions required by the Veterinary Administrations, especially to prevent the risk of introduction of
diseases transmitted by insects.
Article 1.4.2.5.
1. If, for reasons beyond the control of its captain, a ship or aircraft calls or lands somewhere other
than at a port or airport, or at a port or airport other than that at which it should normally call or
land, the captain of the ship or aircraft shall immediately notify the nearest Veterinary Authority or
other public authority of the new port of call or place of landing.
2. As soon as the Veterinary Authority is notified of the calling or landing place, it shall take appropriate
action.
3. Except for the circumstances mentioned in point 5 below, the animals and the attendants on board
the ship or aircraft shall not be permitted to leave the vicinity of the docking or landing place. The
removal from the vicinity, of any equipment, bedding or feedstuffs accompanying them shall not be
permitted.
4. When the measures prescribed by the Veterinary Authority have been carried out, the ship or aircraft
shall be permitted, for animal health purposes, to proceed to the port or airport at which it would
normally have called or landed. If there are technical reasons why this cannot be done, it may be
permitted to proceed to a port or an airport that is more suitable.
5. In an emergency, the captain of the ship or aircraft shall take all necessary measures to maintain the
health and safety of the passengers, crew, attendants and animals on board.
Article 1.4.3.1.
1. Countries and their Veterinary Administrations shall, wherever possible, take the necessary action to
ensure that the border posts and quarantine stations in their territory shall be provided with an adequate
organisation and sufficient equipment for the application of the measures recommended in the
Terrestrial Code.
2. Each border post and quarantine station shall be provided with facilities for the feeding and watering of
animals.
Article 1.4.3.2.
When justified by the amount of international trade and by the epidemiological situation, border posts and
quarantine stations shall be provided with a Veterinary Service comprising personnel, equipment and
premises as the case may be and, in particular, means for:
a) making clinical examinations and obtaining specimens of material for diagnostic purposes from live
animals or carcasses of animals affected or suspected of being affected by an epizootic disease, and
obtaining specimens of animal products suspected of contamination;
b) detecting and isolating animals affected by or suspected of being affected by an epizootic disease;
c) carrying out disinfection and possibly disinfestation of vehicles used to transport animals and animal
products.
In addition to this, each port and international airport should ideally be provided with equipment for the
sterilisation or incineration of swill or any other material dangerous to animal health.
Article 1.4.3.3.
When required for the transit of commodities in international trade, airports shall be provided, as soon as
possible, with areas of direct transit. These must, however, comply with the conditions required by
Veterinary Administrations, especially to prevent the risk of introducing diseases transmitted by insects.
Article 1.4.3.4.
Each Veterinary Administration, when requested, shall make available for the Central Bureau and any
interested country on request:
a) a list of border posts, quarantine stations, approved abattoirs and storage depots in its territory which are
approved for international trade;
b) the period of time required for notice to be given for the application of the arrangements contained
in point 2 of Articles 1.4.4.1. to 1.4.4.4.;
c) a list of airports in its territory which are provided with an area of direct transit.
Article 1.4.4.1.
1. An importing country should only accept into its territory animals which have been subjected to a
health examination by an Official Veterinarian of the exporting country and which are accompanied by
an international veterinary certificate provided by the Veterinary Authority of the exporting country.
2. An importing country may require adequate advance notice regarding the proposed date of entry into
its territory of animals, stating the species, quantity, means of transport and the name of the border
post to be used.
In addition, importing countries shall publish a list of the border posts equipped to conduct control
operations related to importation and enabling the importation and transit procedures to be carried
out in the quickest and most effective way.
3. An importing country may prohibit the introduction into its territory of animals if it considers that
certain diseases exist in the exporting country, or transit countries which precede it in the itinerary, which
are capable of being transmitted to its own animals. In the case of transit countries, the prohibition
should not apply to bees which are transported in securely closed vehicles or containers.
4. An importing country may prohibit the introduction into its territory of animals if these are found, on
examination at the border post by an Official Veterinarian, to be affected by, suspected of being
affected by or infected with a disease capable of being transmitted to the animals in its territory.
Animals which are not accompanied by an international veterinary certificate conforming with the
requirements of the importing country may also be refused entry.
In these circumstances, the Veterinary Administration of the exporting country shall be informed
immediately, thereby providing an opportunity for confirming the findings or correcting the
certificate.
However, the importing country may prescribe that the importation be placed immediately in
quarantine in order to carry out clinical observation and biological examinations with a view to
establishing a diagnosis.
If the diagnosis of an epizootic disease is confirmed, or if the certificate cannot be corrected, the
importing country may take the following measures:
a) return the animals to the exporting country, if this measure does not involve transit through a third
country;
b) slaughter and destroy in cases where return to the exporting country would be dangerous from the
health point of view or impossible from a practical point of view.
5. Animals, accompanied by a valid international veterinary certificate and found to be healthy by the
Veterinary Authority at the border post, shall be permitted to be imported and transported in
accordance with the requirements of the importing country to the point of destination.
Article 1.4.4.2.
b) embryos/ova,
c) hatching eggs,
d) brood-combs of bees,
which are accompanied by an international veterinary certificate.
2. An importing country may require adequate advance notice regarding the proposed date of entry into
its territory of any consignment of the above-mentioned products, stating the species, quantity,
nature and packaging of the products, and the name of the border post to be used.
3. A country may prohibit the importation of the above-mentioned products into its territory if it
considers that certain diseases exist in the exporting country, or in the transit countries which precede it
in the itinerary, which are capable of being introduced by these products into its territory.
4. A country may prohibit the introduction into its territory of the above-mentioned products
presented at one of its border posts, if they are not accompanied by an international veterinary certificate
complying with the requirements of the importing country.
In these circumstances, the Veterinary Administration of the exporting country shall be notified at once,
and the products may be returned to the exporting country or placed in quarantine and/or destroyed.
Article 1.4.4.3.
1. An importing country should only accept into its territory meat and products of animal origin intended
for human consumption which comply with point 1. of Article 1.4.1.6.
2. An importing country may require adequate advance notice regarding the proposed date of entry into
its territory of a consignment of meat or products of animal origin intended for human consumption
together with information on the nature, quantity and packaging of the meat or products, and the
name of the border post to be used.
3. If inspection of the consignment shows that the meat or the products of animal origin intended for
human consumption might be a danger to the health of persons or animals, or if the international
veterinary certificate is not correct or does not apply to the products, the Veterinary Authority of the
importing country may cause the meat or products to be returned or be subjected to adequate treatment
to ensure that they are save. When the products are not returned, the Veterinary Administration of the
exporting country shall be informed immediately, thereby providing an opportunity for confirming the
findings.
Article 1.4.4.4.
1. An importing country should only accept into its territory products of animal origin intended for use in
animal feeding, or for pharmaceutical or surgical or agricultural or industrial use which are
accompanied by an international veterinary certificate provided by the relevant Veterinary Authority of
the exporting country.
2. An importing country may require adequate advance notice regarding the proposed date of entry into
its territory of a consignment of products of animal origin intended for use in animal feeding, or for
pharmaceutical or surgical or agricultural or industrial use, together with information on the nature,
quantity and packaging of these products, and the name of the border post to be used.
3. An importing country may prohibit the importation into its territory of products of animal origin
intended for use in animal feeding, or for pharmaceutical or surgical or agricultural or industrial use if
it considers that certain diseases exist in the exporting country, which are capable of being introduced
by these products. There may also be prohibition of transit through countries where these diseases
exist, except where the transport is carried out in sealed vehicles or containers.
4. When the international veterinary certificates have been examined and found to be correct, the
importation of the above-mentioned products shall be permitted.
5. An importing country may require that the products of animal origin intended for use in animal
feeding, or for pharmaceutical or surgical or agricultural or industrial use, be consigned to
establishments approved by the Veterinary Administration and under its supervision.
6. If inspection of the consignment shows that the products are capable of endangering the health of
persons or animals, or if the international veterinary certificates are not correct or do not apply to the
products, the Veterinary Authorities of the importing country may either return the products to the
exporting country or cause them to be made safe.
When the products are not returned, the Veterinary Administration of the exporting country shall be
informed immediately, thereby providing an opportunity for confirming the findings or correcting
the certificate.
Article 1.4.4.5.
On the arrival at a border post of a vehicle transporting an animal or animals infected with any disease listed
by the OIE, the vehicle shall be considered as contaminated, and the Veterinary Authority shall apply the
following measures:
1. unloading of the vehicle and immediate transportation of the animal or animals, in a leak-proof vehicle
direct to:
a) an establishment approved by the Veterinary Administration for the slaughter of the animal or
animals and the destruction or possibly sterilisation of their carcasses; or
b) a quarantine station or, in the absence of a quarantine station, to a place assigned in advance which
is well isolated and near the border post;
2. unloading of the vehicle and immediate transportation of the litter, forage and any other potentially
contaminated material to an establishment assigned in advance for their destruction, and strict
application of the animal health measures required by the importing country;
3. disinfection of:
a) all baggage of the attendants;
b) all parts of the vehicle which were used in the transport, feeding, watering, moving and unloading
of the animal or animals;
4. disinfestation, in cases where any insect vector diseases are present.
Article 1.4.4.6.
On the arrival at a border post of a vehicle transporting an animal or animals suspected of being affected with
any disease listed by the OIE, the vehicle shall be considered as being contaminated, and the Veterinary
Authority may apply the measures provided in Article 1.4.4.5.
Article 1.4.4.7.
The vehicle shall no longer be considered as contaminated when the measures prescribed by the Veterinary
Authority in accordance with Article 1.4.4.5. have been carried out.
The vehicle may then be allowed to enter.
Article 1.4.4.8.
Ships and aircraft should not be refused access to a port or airport for animal health reasons in cases of
emergency.
Nevertheless, the ship or aircraft should be subjected to all of the animal health measures which the port
or airport Veterinary Authority may consider necessary.
Article 1.4.4.9.
1. An aircraft transporting animals or animal products need not be regarded as coming from an infected
zone solely because it landed in such a zone at one or more airports as long as these airports are not
infected.
This should be considered direct transit provided no offloading of animals and animal products takes
place.
2. Any aircraft coming from a foreign country where animal diseases transmitted by insect vectors are
present shall be subjected to disinfestation immediately after landing, except when such disinfestation
was carried out immediately before departure or during the flight.
INTERNATIONAL TRANSFER
AND LABORATORY CONTAINMENT
OF ANIMAL PATHOGENS
Article 1.4.5.1.
Object
Article 1.4.5.2.
Introduction
1. The consequences of the introduction into a country of an infectious disease or an animal pathogen
or new strain of animal pathogen from which it is currently free, are potentially very serious. This is
because animal health, human health, the agricultural economy and trade may all be adversely
affected to a greater or a lesser degree. Countries will already have in place a range of measures, such
as requirements for pre-import testing and quarantine, to prevent such introductions through the
importation of live animals or their products.
2. However, there is also the risk that disease may occur as a result of the accidental release of animal
pathogens from laboratories that are using them for various purposes such as research, diagnosis or
the manufacture of vaccines. Such pathogens may already occur in the country or they may have
been imported deliberately or inadvertently. It is therefore necessary to have in place measures to
prevent their accidental release. These measures may be applied either at national borders by
prohibiting or controlling the importation of specified pathogens or their carriers (see
Article 1.4.5.7.) or within national boundaries by specifying the conditions under which laboratories
must handle them. In practice, a combination of external and internal controls is likely to be applied
depending on the risk to animal health posed by the pathogen in question.
Article 1.4.5.3.
Purpose
1. To provide guidance on the laboratory containment of animal pathogens according to the risk they
pose to animal health and the agricultural economy of a country, particularly when the disease they
cause is not enzootic.
3. Where animal pathogens also pose a risk to human health, guidance on their laboratory containment
should be sought from the Terrestrial Manual and other relevant published documents.
Article 1.4.5.4.
1. Animal pathogens should be categorised on the risk they pose to animal health, should they be
introduced into a country or accidentally released from a laboratory. In categorising pathogens into
four groups according to containment requirements, the following factors should be taken into
account: the organism's pathogenicity, the biohazard it presents, its ability to spread, the economic
aspects and the availability of prophylactic and therapeutic treatments.
2. Some pathogens need to be transmitted by specific vectors or require intermediate hosts to complete
their life cycles before they can infect animals and cause disease. In countries where such vectors or
intermediate hosts do not occur, or where climatic or environmental factors mitigate against their
survival, the pathogen poses a lower risk to animal health than in countries where such vectors or
intermediate hosts occur naturally or could survive.
3. When categorising animal pathogens into specific groups, the following criteria should be taken into
account:
a) Group 1 animal pathogens
Disease producing organisms which are enzootic but not subject to official control.
b) Group 2 animal pathogens
Disease producing organisms which are either exotic or enzootic but subject to official control
and which have a low risk of spread from the laboratory.
i) They do not depend on vectors or intermediate hosts for transmission.
ii) There is a very limited or no transmission between different animal species.
iii) Geographical spread if released from the laboratory is limited.
iv) Direct animal to animal transmission is relatively limited.
v) The need to confine diseased or infected non-diseased animals is minimal.
vi) The disease is of limited economic and/or clinical significance.
c) Group 3 animal pathogens
Disease producing organisms which are either exotic or enzootic but subject to official control
and which have a moderate risk of spread from the laboratory.
i) They may depend on vectors or intermediate hosts for transmission.
ii) Transmission between different animal species may readily occur.
iii) Geographical spread if released from the laboratory is moderate.
iv) Direct animal to animal transmission occurs relatively easily.
v) The statutory confinement of diseased, infected and in-contact animals is necessary.
vi) The disease is of severe economic and/or clinical significance.
vii) Prophylactic and/or therapeutic treatments are not readily available or of limited benefit.
d) Group 4 animal pathogens
Disease producing organisms which are either exotic or enzootic but subject to official control
and which have a high risk of spread from the laboratory.
i) They may depend on vectors or intermediate hosts for transmission.
ii) Transmission between different animal species may occur very readily.
iii) Geographical spread if released from the laboratory is widespread.
Article 1.4.5.5.
Containment levels
1. The principal purpose of containment is to prevent the escape of the pathogen from the laboratory
into the national animal population. Some animal pathogens can infect man. In these instances the
risk to human health may demand additional containment than would otherwise be considered
necessary from purely animal health considerations.
2. The level of physical containment and biosecurity procedures and practices should be related to the
group into which the pathogen has been placed, and the detailed requirements should be appropriate
to the type of organism (i.e. bacterium, virus, fungus or parasite). The lowest containment level will
be required for pathogens in group 1 and the highest level for those in group 4. Guidance on the
containment requirements for groups 2, 3 and 4 is provided in Table 1.
3. Arthropods may be pathogens or vectors for pathogens. If they are a vector for a pathogen being
used in the laboratory, the appropriate containment level for the pathogen will be necessary in
addition to the containment facilities for the arthropod.
Article 1.4.5.6.
1. A laboratory should be allowed to possess and handle animal pathogens in group 3 or 4 only if it can
satisfy the relevant authority that it can provide containment facilities appropriate to the group.
However, depending on the particular circumstances of an individual country, the authority might
decide that the possession and handling of certain pathogens in group 2 should also be controlled.
The authority should first inspect the facilities to ensure they are adequate and then issue a licence
specifying all relevant conditions. There should also be a requirement for appropriate records to be
kept and for the authority to be notified if it is suspected that a material being handled contains a
pathogen not covered by the licence. The authority should visit the laboratory periodically to ensure
licence conditions are being complied with. It is important that authority staff carrying out the visit
should not have any contact with species susceptible to the pathogens being handled at the
laboratory for a specified period after visiting the laboratory. The length of this period will depend
on the pathogen.
2. Licences should specify:
a) how the pathogen is to be transported and the disposal of the packaging;
b) the name of the person responsible for the work;
c) whether the pathogen may be used in vivo (and if so whether in laboratory animals or other
animals) and/or only in vitro;
d) how the pathogen and any experimental animals should be disposed of when the work is
completed;
e) limitations on contact by laboratory staff with species susceptible to the pathogens being used;
f) conditions for the transfer of pathogens to other laboratories;
g) specific conditions relating to the appropriate containment level and biosecurity procedures and
practices.
Article 1.4.5.7.
1. The importation of any animal pathogen, pathological material or organisms carrying the pathogen
should be permitted only under an import licence issued by the relevant authority. The import
licence should contain conditions appropriate to the risk posed by the pathogen and, in relation to
air transport, the appropriate standards of the International Air Transport Association concerning
the packaging and transport of hazardous substances. The import licence for group 2, 3 or 4 should
only be granted to a laboratory that is licensed to handle the particular pathogen as in Article 1.4.5.6.
2. When considering applications to import pathological material from other countries, the authorities
should have regard to the nature of the material, the animal from which it is derived, the
susceptibility of that animal to various diseases and the animal health situation of the country of
origin. It may be advisable to require that material is pre-treated before import to minimise the risk
of inadvertent introduction of a pathogen.
Table 1. Guidance on the laboratory requirements for the different containment groups
CONTAINMENT GROUP
REQUIREMENTS OF THE
2 3 4
LABORATORY
A) Laboratory siting and structure
1. Not next to known fire hazard Yes Yes Yes
2. Workplace separated from other
Yes Yes Yes
activities
3. Personnel access limited Yes Yes Yes
4. Protected against entry/exit of
Yes Yes Yes
rodents and insects
Yes and Yes and
5. Liquid effluent must be sterilised
monitored monitored
6. Isolated by airlock. Continuous
Yes Yes
internal airflow
7. Input and extract air to be filtered Single for input,
Single on extract
using HEPA or equivalent double for extract
8. Mechanical air supply system with
Yes Yes
fail-safe system
9. Laboratory sealable to permit
Yes Yes
fumigation
10. Incinerator for disposal of carcasses
Available Yes Yes on site
and waste
Table 1. Guidance on the laboratory requirements for the different containment groups (contd)
CONTAINMENT GROUP
REQUIREMENTS OF THE
2 3 4
LABORATORY
B) Laboratory facilities
11. Class 1/2/3 exhaust protective
Yes Yes Yes
cabinet available
Yes with Yes with
12. Direct access to autoclave Yes
double doors double doors
13. Specified pathogens stored in
Yes Yes Yes
laboratory
14. Double ended dunk tank required Preferable Yes
15. Protective clothing not worn outside
Yes Yes Yes
laboratory
16. Showering required before exiting
Yes
laboratory
17. Safety Officer responsible for
Yes Yes Yes
containment
18. Staff receive special training in the
Yes Yes Yes
requirements needed
C) Laboratory discipline
19. Warning notices for containment
Yes Yes Yes
area
20. Laboratory must be lockable Yes Yes Yes
21. Authorised entry of personnel Yes Yes Yes
22. On entering all clothing removed and
Yes Yes
clean clothes put on
23. On exiting all laboratory clothes
removed, individual must wash and Yes
transfer to clean side
24. Individual must shower prior to
Yes
transfer to clean side
25. All accidents reported Yes Yes Yes
D) Handling of specimens
26. Packaging requirements to be advised
Yes Yes Yes
prior to submission
27. Incoming packages opened by
Yes Yes Yes
trained staff
28. Movement of pathogens from an
approved laboratory to another Yes Yes Yes
requires a licence
29. Standard Operating Procedures
Yes Yes Yes
covering all areas must be available
CHAPTER 1.5.1.
GENERAL CONSIDERATIONS
Article 1.5.1.1.
All products, including biologicals for veterinary use, derived from animals have some capacity to transmit
animal disease. The level of this capacity depends on the inherent nature of the products, their source, the
treatment that they might have undergone, and the purpose for which they are intended. Biologicals for in
vivo use in particular will have the highest probability of exposure to animals and as such present the
highest risk. Products used for in vitro purposes can introduce disease into animal populations through
deliberate or inadvertent use in vivo, contamination of other biologicals, or spread by other means. Even
products for diagnosis and research have the potential for close contact with animals. Exotic
micro-organisms, some highly pathogenic, which may be held for research and diagnostic purposes in
countries free from infection or the diseases they cause, could possibly contaminate other biological
products.
Veterinary Administrations of importing countries shall make available specific procedural requirements for
approval or licensing of biologicals for veterinary use. They may limit supply to registered institutions or
in vitro use or for non-veterinary purposes where such assurance cannot be provided.
Article 1.5.2.1.
Introduction
Risk analysis for veterinary vaccines has to be founded on the principles of quality assurance, which
includes quality control, in the production of veterinary vaccines. These recommendations are focused
mainly on the risk related to the contamination of vaccines by infectious agents particularly in regard to
the risk of importing exotic diseases. The major risk of introducing a disease into a country is through
importation of live animals or animal products and rarely through veterinary vaccines. Veterinary vaccines
can however be contaminated by disease agents if master seeds, strains, cell cultures, animals or
ingredients of animal origin such as foetal calf serum used in production are contaminated or if cross
contamination occurs during the production process.
Article 1.5.2.2.
Principles
Exporting countries and importing countries should agree on a system of classification of risks associated with
veterinary vaccines taking into account factors such as purification procedures which have been applied.
Exporting countries and importing countries should agree on risk analysis models to address specific issues
and products. Such risk analysis models should include a scientific risk assessment and formalised
procedures for making risk management recommendations and communicating risk. The regulation of
veterinary vaccines should include the use of either qualitative or quantitative models.
Risk analysis should be as objective and transparent as possible. Step risk and scenario tree methods
should be used in risk assessment whenever appropriate, as they identify the critical steps in the
production and use of the products where risks arise and help to characterise those risks.
The same conclusions about risk analysis may be reached by differing methods. Where methods may
differ in countries, the concept of equivalence should apply wherever possible and the methods should be
validated to ensure they are of comparable sensitivity.
Article 1.5.2.3.
Manufacturing practices
The manufacture of veterinary vaccines has special characteristics which should be taken into
consideration when implementing and assessing the quality assurance system. Due to the large number of
animal species and related pathogenic agents, the variety of products manufactured is very wide and the
volume of manufacture is often low; hence, work on a group basis is common. Moreover, because of the
very nature of this manufacture (cultivation steps, lack of terminal sterilisation, etc.), the products must be
particularly well protected against contamination and cross contamination. The environment must also be
protected especially when the manufacture involves the use of pathogenic or exotic biological agents and
the worker must be particularly well-protected when the manufacture involves the use of biological agents
pathogenic to man.
These factors, together with the inherent variability of immunological products, means that the role of the
quality assurance system is of the utmost importance. It is important that vaccines should be
manufactured in accordance with a recognised codified system that includes specifications regarding
equipment, premises, qualification of personnel as well as quality assurance and regular inspections.
A commonly agreed system of facility inspection carried out by qualified and specialised inspectors must
be in place to assure confidence.
Article 1.5.2.4.
The manufacturer or Veterinary Administration of the exporting country should make available to the
importing country the pharmacopoeia it uses. For the importing country it is necessary to have documented
both the quality control methods used and the source of each batch of starting materials. The key steps of
the manufacturing process of veterinary vaccines should be described in detail to help risk analysis. Risk
analysis has to be focused on the quality and safety parts of the application file. Laboratory safety testing
should cover target and non-target organisms to obtain sufficient biological data. All test procedures used
should correspond with the state of scientific knowledge at the time and should be validated.
The description of the method of preparation of the finished product should include an adequate
characterisation of the substances needed to prepare the working seeds, the description of the treatments
applied to starting materials to prevent contamination, and a statement of the stages of manufacture at
which sampling is carried out for process control tests.
The results of control tests during production and on finished product, as well as the sensitivity of these
tests, have to be available for risk analysis. The stepwise procedures of the control tests should also be
available.
Article 1.5.2.5.
To assist in risk analysis, countries should establish a system of categorisation of veterinary vaccines
taking into account criteria such as pathogens used as active ingredients, their inherent characteristics and
the risk they pose.
In case of live vectored vaccines, the safety of the vector to the targeted and non-targeted species and to
human beings must be assessed. Special attention should be paid to potential tissue tropism or host range
modification of the recombinant.
Article 1.5.2.6.
Vaccinovigilance
Exporting countries and importing countries should ensure that a reliable system of vaccinovigilance (post
licensing monitoring) is established to identify, at the earliest stage, any serious problems encountered
from the use of veterinary vaccines. Vaccinovigilance should be ongoing and an integral part of all
regulatory programmes for veterinary vaccines, especially live vaccines.
Article 1.5.2.7.
Risk communication
Reliable data in support of applications submitted in importing countries should be provided by the
manufacturer or the Veterinary Administration of the exporting country. Relevant data on risk analysis,
changes in animal health situations and vaccinovigilance should be shared by Veterinary Administrations on
a continuous basis.
Article 1.5.3.1.
Introduction
For the purpose of this chapter, the term ‘biologicals’ means ‘biologicals for veterinary use other than
veterinary vaccines’.
Article 1.5.3.2.
Categorisation of biologicals
Categorisation provides a means of facilitating risk analysis for the international trade in biologicals.
The categorisation system should take into account the source, the nature and the stated purpose of the
biologicals. By conducting generic risk analyses, and by developing generic certification and quality
assurance, continued supply of products can be made available without the need for repeated risk
assessments that are expensive and consume significant resources. Once made, the risk assessment can be
linked to appropriate manufacturing and testing parameters. Categories of biologicals for veterinary use
into which generic risk assessments could apply may include (not in order of risk):
1. synthetic material;
2. amino acids, alcohols, esters, sugars and vitamins;
3. cosmetics;
4. plant extracts and processed biochemicals of plant origin;
5. products derived by microbial fermentation;
6. diagnostic, analytical and immunochemical kits for in vitro use;
7. material of human origin;
8. therapeutics;
9. implantables of animal origin;
10. antibodies and immunoglobulins;
11. deoxyribonucleic acid (DNA), ribonucleic acid (RNA), restriction enzymes and other products of
molecular biology;
12. cell-lines and hybridomas;
13. animal proteins, hormones, enzymes, albumins, tissue extracts and culture media containing animal
material;
14. animal serum;
15. micro-organisms (conventional or genetically modified);
16. probiotics;
17. preserved specimens, microscope slides and smears.
All of these materials may contain pathogens depending on their source and processing procedures.
Article 1.5.3.3.
When undertaking risk analysis for biologicals, Veterinary Administrations should follow the Terrestrial
Manual. The manufacturer or the Veterinary Administration of the exporting country should make available
detailed information, in confidence if necessary, on the source of the materials used in the manufacture of
the product (e.g. substrates). They should make available details of the method of manufacture (and
where appropriate inactivation) of the substrates and component materials, the quality assurance
procedures for each step in the process, final product testing regimes, and the pharmacopoeia with which
the product must conform in the country of origin. They should also make available challenge organisms,
their biotypes and reference sera, and other means of appropriate product testing.
Article 1.5.3.4.
Risk analysis should be as objective and transparent as possible and should be performed in accordance
with Section 1.3. of the Terrestrial Code, and certification in line with Section 1.2. of the Terrestrial Code. Of
necessity, assessment of the country and commodity factors and risk reduction measures will be based
largely on manufacturers' data. These data depend on quality assurance at all stages of manufacture, rather
than on testing of the final product alone.
Domestic exposure may be influenced by the approved usage of the product. Veterinary Administrations
may place limits on usage of some products (e.g. restricting usage to institutions of appropriate
biosecurity).
Article 1.5.3.5.
Biocontainment
Suitable biocontainment may be necessary for many forms of biologicals. In particular, the importation of
exotic micro-organisms should be carried out in accordance with Chapter 1.4.5.
RECOMMENDATIONS APPLICABLE TO
SPECIFIC DISEASES
CHAPTER 2.1.1.
Article 2.1.1.1.
The criteria for the inclusion of a disease in the OIE List are as follows:
Basic criteria Parameters (at least one 'yes' answer means that
the criterion has been met)
International Spread Has international spread been proven on three or
more occasions? OR
Are more than three countries with populations of
susceptible animals free of the disease or facing
impending freedom (based on the Terrestrial Code
provisions, especially Appendix 3.8.1)? OR
Do OIE annual reports indicate that a significant
number of countries with susceptible populations have
reported absence of the disease for several consecutive
years?
Significant Spread within Naïve Populations Does the disease exhibit significant mortality at the
level of a country or zone/compartment? AND/OR
Does the disease exhibit significant morbidity at the
level of a country or zone/compartment?
Zoonotic Potential Has transmission to humans been proven? (with the
exception of artificial circumstances) AND
Is human infection associated with severe
consequences? (death or prolonged illness)
Emerging Diseases Is there rapid spread and/or apparent zoonotic
properties?
Article 2.1.1.2.
The criteria in Article 2.1.1.1. above are applied according to the decision-making model shown below:
Article 2.1.1.3.
- Q fever
- Rabies
- Rift Valley fever
- Rinderpest
- Trichinellosis
- Tularemia
- Vesicular stomatitis
- West Nile fever.
2. The following diseases are included within the category of cattle diseases:
- Bovine anaplasmosis
- Bovine babesiosis
- Bovine genital campylobacteriosis
- Bovine spongiform encephalopathy
- Bovine tuberculosis
- Bovine viral diarrhoea
- Contagious bovine pleuropneumonia.
- Enzootic bovine leukosis
- Haemorrhagic septicaemia
- Infectious bovine rhinotracheitis/infectious pustular vulvovaginitis
- Lumpy skin disease
- Malignant catarrhal fever
- Theileriosis
- Trichomonosis
- Trypanosomosis (tsetse-transmitted).
3. The following diseases are included within the category of sheep and goat diseases:
- Caprine arthritis/encephalitis
- Contagious agalactia
- Contagious caprine pleuropneumonia
- Enzootic abortion of ewes (ovine chlamydiosis)
- Maedi–visna
- Nairobi sheep disease
- Ovine epididymitis (Brucella ovis)
- Peste des petits ruminants
- Salmonellosis (S. abortusovis)
- Scrapie
- Sheep pox and goat pox.
4. The following diseases are included within the category of equine diseases:
- African horse sickness
- Contagious equine metritis
- Dourine
- Equine encephalomyelitis (Eastern)
- Equine encephalomyelitis (Western)
- Equine infectious anaemia
- Equine influenza
- Equine piroplasmosis
- Equine rhinopneumonitis
- Equine viral arteritis
- Glanders
- Surra (Trypanosoma evansi)
- Venezuelan equine encephalomyelitis.
5. The following diseases are included within the category of swine diseases:
- African swine fever
- Classical swine fever
- Nipah virus encephalitis
- Porcine cysticercosis
- Porcine reproductive and respiratory syndrome
- Swine vesicular disease
- Transmissible gastroenteritis.
6. The following diseases are included within the category of avian diseases:
- Avian chlamydiosis
- Avian infectious bronchitis
- Avian infectious laryngotracheitis
- Avian mycoplasmosis (M. gallisepticum)
- Avian mycoplasmosis (M. synoviae)
- Duck virus hepatitis
- Fowl cholera
- Fowl typhoid
- Highly pathogenic avian influenza
- Infectious bursal disease (Gumboro disease)
- Marek's disease
- Newcastle disease
- Pullorum disease
- Turkey rhinotracheitis.
7. The following diseases are included within the category of lagomorph diseases:
- Myxomatosis
- Rabbit haemorrhagic disease.
8. The following diseases are included within the category of bee diseases:
- Acarapisosis of honey bees
- American foulbrood of honey bees
- European foulbrood of honey bees
- Small hive beetle infestation (Aethina tumida)
- Tropilaelaps infestation of honey bees
- Varroosis of honey bees.
9. The following diseases are included within the category of other diseases:
- Camelpox
- Leishmaniosis.
CHAPTER 2.2.1.
ANTHRAX
Article 2.2.1.1.
There is no evidence that anthrax is transmitted by animals before the onset of clinical and pathological
signs. Early detection of outbreaks, quarantine of affected premises, destruction of diseased animals and
fomites, and implementation of appropriate sanitary procedures at abattoirs and dairy factories will ensure
the safety of products of animal origin intended for human consumption.
For the purposes of this Terrestrial Code, the incubation period for anthrax shall be 20 days.
Anthrax should be notifiable in the whole country.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.2.1.2.
Article 2.2.1.3.
Article 2.2.1.4.
Article 2.2.1.5.
Article 2.2.1.6.
Article 2.2.1.7.
AUJESZKY'S DISEASE
Article 2.2.2.1.
The Aujeszky's disease (AD) free or provisionally free status of a country or zone can only be determined
if the following conditions are fulfilled:
1. a risk analysis has been conducted identifying all potential factors for AD occurrence and their
historic perspective;
2. AD is notifiable in the whole country, and all clinical cases suggestive of AD are subjected to field
and laboratory investigations;
3. an on-going awareness programme is in place to encourage reporting of all cases suggestive of AD in
susceptible species;
4. the Veterinary Administration has current knowledge of, and authority over, all establishments
containing pigs in the whole country;
5. domestic pigs are properly identified when leaving their establishment of origin with an indelible mark
giving the identification number of their herd of origin; a reliable tracing back procedure is in place
for all pigs leaving their establishment of origin.
An AD infected establishment means an establishment in which the virus has been isolated or identified, or a
positive serological result (total or gE antibodies) has been confirmed in a laboratory.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.2.2.2.
1. Qualification
A country or zone may be considered free from the disease without formally applying a specific
surveillance programme (historical freedom) if the disease has not been reported for at least 25 years,
and if for at least the past 10 years:
a) it has been a notifiable disease;
b) an early detection system has been in place;
c) measures to prevent the introduction of the AD virus into the country or zone have been in
place;
d) no vaccination against the disease has been carried out;
e) infection is not known to be established in wild swine, or measures have been implemented to
prevent any transmission of the AD virus from wild swine to domestic pigs.
A country or zone which does not meet the conditions of the above paragraph may be considered
free from AD when:
f) animal health regulations to control the movement of commodities listed in Article 2.2.2.6. in
order to prevent the introduction of infection into the establishments of the country or zone have
been in place for at least 2 years;
g) vaccination against AD has been banned for all domestic pigs in the country or zone for at least
2 years;
h) if AD has never been reported in the country or zone, serological surveys, with negative results,
have been conducted on a representative sample of all pig establishments in conformity with the
guidelines in Appendix 3.8.X. (under study) no more than 3 years prior to qualification; the
serological surveys should be directed at the detection of antibodies to the whole virus, and
based on the breeding pig population or, for establishments that contain no breeding pigs, on a
comparable number of fattening pigs; or
i) if AD has been reported in the country or zone, a surveillance and control programme has been
in place to detect every infected establishment and eradicate AD from it; the surveillance
programme should be carried out in conformity with the guidelines in Appendix 3.8.X. (under
study) and demonstrate that no establishments within the country or zone have had any clinical,
virological or serological evidence of AD for at least 2 years.
In order for a country to reach free status, all of its zones must have reached AD free status.
In countries or zones with wild swine, measures should be implemented to prevent any transmission
of the AD virus from wild swine to domestic pigs.
2. Maintenance of free status
In order to maintain its free status, a country or zone should comply with the following
requirements:
a) periodic serological surveys directed at the detection of antibodies to the whole AD virus
should be carried out on a statistically significant number of breeding pigs, in conformity with
the guidelines in Appendix 3.8.X. (under study);
b) the importation of the commodities listed in Article 2.2.2.6. into the country or zone is carried out
in conformity with the import conditions contained in the relevant Articles of the present
Chapter;
c) the ban on AD vaccination remains in force;
d) measures aimed at preventing the transmission of the AD virus from wild swine to domestic
pigs remain in force.
3. Recovery of free status
Should an AD outbreak occur in an establishment of a free country or zone, the status of the country
or zone may be restored if either:
a) all the pigs in the outbreak have been slaughtered; and, during and after the application of this
measure, an epidemiological investigation including clinical examination, and serological and/or
virological testing has been carried out in all pig establishments which have been directly or
indirectly in contact with the infected establishment and in all pig establishments located within a
5-kilometre radius of the outbreak, demonstrating that these establishments are not infected, or
b) vaccination with gE- deleted vaccines has been applied and:
i) a serological testing procedure (differential ELISA) has been implemented in the
establishments where vaccination has been applied to demonstrate the absence of infection;
ii) the movement of pigs from these establishments has been banned, except for immediate
slaughter, until the above procedure has demonstrated the absence of infection;
iii) all vaccinated animals have been slaughtered;
iv) during and after the application of the measures described in points i) to iii) above, a
thorough epidemiological investigation including clinical examination and serological
and/or virological testing has been carried out in all pig establishments which have been
directly or indirectly in contact with the infected establishment and in all pig establishments
located within a 5-kilometre radius of the outbreak, demonstrating that these establishments
are not infected.
Article 2.2.2.3.
1. Qualification
A country or zone may be considered as provisionally free from AD if the following conditions are
complied with:
a) animal health regulations to control the movement of commodities listed in Article 2.2.2.6. in
order to prevent the introduction of infection into the establishments of the country or zone have
been in place for at least 2 years;
b) if AD has never been reported in the country or zone, a serological survey, with negative results,
has been conducted on a representative sample of all pig establishments in conformity with the
guidelines in Appendix 3.8.X. (under study) (at a level of confidence not sufficient to meet
requirements for freedom); the serological survey should be directed at the detection of
antibodies to the whole virus, and based on the breeding pig population or, for establishments
that contain no breeding pigs, on a comparable number of fattening pigs; or
c) if AD has been reported in the country or zone, a surveillance and control programme has been
in place to detect infected establishments and eradicate AD from these establishments, the herd
prevalence rate in the country or zone has not exceeded 1% for at least 3 years (the sampling
procedure described in point 1)e) of the definition of ‘AD free establishment’ should be applied
within the establishments of the country or zone), and at least 90% of the establishments in the
country or zone are qualified free;
d) in countries or zones with wild swine, measures should be taken to prevent any transmission of
the AD virus between wild swine and domestic pigs.
2. Maintenance of provisionally free status
In order to maintain its provisionally free status, a country or zone should comply with the following
requirements:
a) the measures described in points 1)b) and 1)d) above should be continued;
b) the percentage of infected establishments remains <1%;
c) the importation of the commodities listed in Article 2.2.2.6. into the country or zone is carried out
in conformity with the import conditions contained in the relevant Articles of the present
Chapter.
3. Recovery of provisionally free status
Should the percentage of infected establishments exceed 1% in a provisionally free country or zone,
the status of the country or zone is cancelled and may be restored only once the percentage of
infected establishments has remained <1% for at least 6 months, and this result is confirmed by a
serological survey conducted in conformity with point 1)c) above.
Article 2.2.2.4.
Countries and zones which do not fulfil the conditions to be considered free or provisionally free of AD
should be considered as infected.
Article 2.2.2.5.
AD free establishment
1. Qualification
To qualify as free from AD, an establishment should satisfy the following conditions:
a) it is under the control of the Veterinary Authority;
b) no clinical, virological or serological evidence of AD has been found for at least one year;
c) the introduction of pigs, semen and embryos/ova into the establishment is carried out in
conformity with the import conditions for these commodities contained in the relevant Articles of
the present Chapter;
d) vaccination against AD has not been carried out in the establishment for at least 12 months, and
any previously vaccinated pigs are free from gE antibodies;
e) a number of breeding pigs from the establishment has been subjected, with negative results, to
serological tests to the whole AD virus, applying a sampling procedure set out in conformity
with the guidelines in Appendix 3.8.X. (under study); these tests must have been carried out on
two occasions, at an interval of 2 months; for establishments that contain no breeding pigs, the
tests should be carried out only once on a comparable number of fattening or weaning pigs;
f) a surveillance and control programme has been in place to detect infected establishments located
within a 5-kilometre radius of the establishment and no establishment is known to be infected
within this zone.
2. Maintenance of free status
For establishments located in an infected country or zone, the testing procedure described in point 1)e)
above should be carried out every 4 months.
For establishments located in a provisionally free country or zone, the testing procedure described in
point 1)e) above should be carried out every year.
3. Recovery of free status
Should a free establishment become infected, or should an outbreak occur within a 5-kilometre radius
of a free establishment, the free status of the establishment should be suspended until the following
conditions are met:
a) in the infected establishment:
i) all the pigs in the establishment have been slaughtered, or
ii) at least 30 days after removal of all infected animals, all breeding animals have been
subjected to a serological test to the whole AD virus, with negative results, on
two occasions, at an interval of 2 months;
b) in other establishments located in the 5-kilometre radius zone: a number of breeding pigs from
each establishment has been subjected, with negative results, to serological tests to the whole AD
virus (non vaccinated establishments) or to gE antibodies (vaccinated establishments), applying the
sampling procedure described in point 1e) above.
Article 2.2.2.6.
Veterinary Administrations of countries shall consider whether there is a risk with regard to AD in
accepting importation or transit through their territory, from other countries, of the following commodities:
1. domestic and wild swine;
2. semen of domestic and wild swine;
Article 2.2.2.7.
When importing from AD free countries or zones, Veterinary Administrations should require:
for domestic pigs
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of AD on the day of shipment;
2. come from an establishment located in an AD free country or zone;
3. have not been vaccinated against AD.
Article 2.2.2.8.
When importing from AD provisionally free countries or zones, Veterinary Administrations should require:
for domestic pigs for breeding or rearing
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of AD on the day of shipment;
2. have been kept exclusively in AD free establishments since birth;
3. have not been vaccinated against AD;
4. were subjected to a serological test to the whole AD virus, with negative results, within 15 days prior
to shipment.
Article 2.2.2.9.
When importing from AD infected countries or zones, Veterinary Administrations should require:
for domestic pigs for breeding or rearing
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of AD on the day of shipment;
2. were kept exclusively in AD free establishments since birth;
3. have not been vaccinated against AD;
4. were isolated in the establishment of origin or a quarantine station, and were subjected to a serological
test to the whole AD virus, with negative results, on two occasions, at an interval of not less than
30 days between each test, the second test being performed during the 15 days prior to shipment.
Article 2.2.2.10.
When importing from AD provisionally free countries or zones or AD infected countries or zones,
Veterinary Administrations should require:
Article 2.2.2.11.
When importing from AD free countries or zones, Veterinary Administrations should require:
for wild swine
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of AD on the day of shipment;
2. were captured in an AD free country or zone;
3. have not been vaccinated against the disease;
4. were isolated in a quarantine station, and were subjected to a serological test to the whole AD virus,
with negative results, on two occasions, at an interval of not less than 30 days between each test, the
second test being performed during the 15 days prior to shipment.
Article 2.2.2.12.
When importing from AD free countries or zones, Veterinary Administrations should require:
for semen of pigs
the presentation of an international veterinary certificate attesting that:
1. the donor animals:
a) showed no clinical sign of AD on the day of collection of the semen;
b) were kept in an establishment or artificial insemination centre located in an AD free country or zone
at the time of semen collection;
2. the semen was collected, processed and stored in conformity with the provisions of Appendix 3.2.2.
Article 2.2.2.13.
When importing from AD provisionally free countries or zones, Veterinary Administrations should require:
Article 2.2.2.14.
When importing from AD infected countries or zones, Veterinary Administrations should require:
for semen of pigs
the presentation of an international veterinary certificate attesting that:
1. the donor animals:
a) were kept in an AD free establishment for at least 6 months prior to entering the artificial
insemination centre;
b) have been kept for at least 4 months prior to semen collection in the artificial insemination centre
which has the status of AD free establishment, and where all boars are subjected to a serological
test to the whole AD virus, with negative results, every 4 months;
c) were subjected to a serological test to the whole AD virus, with negative results, within 10 days
prior to or 21 days after semen collection;
d) showed no clinical sign of AD on the day of collection;
2. the semen was collected, processed and stored in conformity with the provisions of Appendix 3.2.2.
Article 2.2.2.15.
When importing from AD free countries or zones, Veterinary Administrations should require:
for in vivo derived embryos of pigs
the presentation of an international veterinary certificate attesting that:
1. the donor females:
a) showed no clinical sign of AD on the day of collection of the embryos;
b) were kept in an establishment located in an AD free country or zone prior to collection;
2. the embryos were collected, processed and stored in conformity with the provisions of
Appendix 3.3.1.
Article 2.2.2.16.
When importing from AD provisionally free countries or zones, Veterinary Administrations should require:
Article 2.2.2.17.
When importing from AD infected countries or zones, Veterinary Administrations should require:
for in vivo derived embryos of pigs
the presentation of an international veterinary certificate attesting that:
1. the donor females:
a) showed no clinical sign of AD on the day of collection of the embryos;
b) were kept in an AD free establishment for at least 3 months prior to collection;
c) were subjected to a serological test to the whole AD virus, with negative results, within 10 days
prior to collection;
2. the embryos were collected, processed and stored in conformity with the provisions of
Appendix 3.3.1.
Article 2.2.2.18.
When importing from AD free countries or zones, Veterinary Administrations should require:
for offal (head, and thoracic and abdominal viscera) of pigs or products containing pig offal
the presentation of an international veterinary certificate attesting that the entire consignment of offal or
products containing pig offal comes from animals which come from establishments located in an AD free
country or zone.
Article 2.2.2.19.
When importing from AD provisionally free countries or zones or from AD infected countries or zones,
Veterinary Administrations should require:
for offal (head, and thoracic and abdominal viscera) of pigs
the presentation of an international veterinary certificate attesting that the entire consignment of offal comes
from animals:
1. which have been kept in an AD free establishment since birth;
2. which have not been in contact with animals from establishments not considered free from AD during
their transport to the approved abattoir and therein.
Article 2.2.2.20.
When importing from AD provisionally free countries or zones or from AD infected countries or zones,
Veterinary Administrations should require:
for products containing pig offal (head, and thoracic and abdominal viscera)
the presentation of an international veterinary certificate attesting that:
1. either the entire consignment of offal used to prepare the products complied with the conditions
referred to in Article 2.2.2.19.; or
2. the products have been processed to ensure the destruction of the AD virus; and
3. the necessary precautions were taken after processing to avoid contact of the products with any
source of AD virus.
ECHINOCOCCOSIS/HYDATIDOSIS
Article 2.2.3.1.
Article 2.2.3.2.
LEPTOSPIROSIS
Article 2.2.4.1.
Under study.
RABIES
Article 2.2.5.1.
For the purposes of this Terrestrial Code, the incubation period for rabies shall be 6 months, and the infective
period in domestic carnivores starts 15 days before the onset of the first clinical signs and ends when the
animal dies.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.2.5.2.
Article 2.2.5.3.
When importing from rabies free countries, Veterinary Administrations should require:
for domestic mammals, and wild mammals reared under confined conditions
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of rabies on the day of shipment;
2. were kept since birth or for the 6 months prior to shipment in a rabies free country or were
imported in conformity with the regulations stipulated in Articles 2.2.5.5., 2.2.5.6. or 2.2.5.7.
Article 2.2.5.4.
When importing from rabies free countries, Veterinary Administrations should require:
for wild mammals not reared under confined conditions
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of rabies on the day of shipment;
2. have been captured in a rabies free country, at a sufficient distance from any infected country. The
distance should be defined according to the species exported and the reservoir species in the infected
country.
Article 2.2.5.5.
When importing from countries considered infected with rabies, Veterinary Administrations should require:
for dogs and cats
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of rabies within 48 hours of shipment;
AND EITHER
2. were vaccinated against rabies:
a) not less than 6 months and not more than one year prior to shipment in the case of a primary
vaccination, which should have been carried out when the animals were at least 3 months old;
b) not more than one year prior to shipment in the case of a booster vaccination;
c) with an inactivated virus vaccine;
3. were identified by a permanent mark (including a microchip) before the vaccination (their
identification number shall be stated in the certificate);
4. were subjected not less than 3 months and not more than 24 months prior to shipment to an
antibody test as prescribed in the Terrestrial Manual with a positive result equivalent to at least
0.5 IU/ml;
OR
5. have not been vaccinated against rabies or do not meet all the conditions set out in points 1), 2), 3)
and 4) above; in such cases, the importing country may require the placing of the animals in a quarantine
station located on its territory, in conformity with the conditions stipulated in its animal health
legislation.
Article 2.2.5.6.
When importing from countries considered infected with rabies, Veterinary Administrations should require:
for domestic ruminants, equines and pigs
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of rabies on the day of shipment;
2. were kept for the 6 months prior to shipment in an establishment where separation from wild and
feral animals was maintained and where no case of rabies was reported for at least 12 months prior to
shipment.
Article 2.2.5.7.
When importing from countries considered infected with rabies, Veterinary Administrations should require:
for laboratory reared rodents and lagomorphs, and lagomorphs or wild mammals (other than non-human
primates) reared under confined conditions
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of rabies on the day of shipment;
2. were kept since birth, or for the 12 months prior to shipment, in an establishment where no case of
rabies was reported for at least 12 months prior to shipment.
Article 2.2.5.8.
When importing from countries considered infected with rabies, Veterinary Administrations should require:
for wild mammals not belonging to the orders of primates or carnivores and not reared under confined
conditions
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of rabies on the day of shipment;
2. were kept in a quarantine station for the 6 months prior to shipment.
Article 2.2.5.9.
When importing from countries considered infected with rabies, Veterinary Administrations should require:
for frozen semen of dogs
the presentation of an international veterinary certificate attesting that the donor animals showed no clinical
sign of rabies during the 15 days following collection of the semen.
PARATUBERCULOSIS
Article 2.2.6.1.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
HEARTWATER
Article 2.2.7.1.
Article 2.2.7.2.
Veterinary Administrations of countries free from heartwater may prohibit importation or transit through
their territory, from countries considered infected with heartwater, of domestic and wild ruminants.
Article 2.2.7.3.
When importing from countries considered infected with heartwater, Veterinary Administrations should
require:
2. were subjected to a diagnostic test for heartwater with negative results during the 15 days prior to
shipment;
3. were treated with acaricides prior to shipment and were completely free of ticks.
Article 2.2.8.1.
When importing from countries considered infested with new world or old world screwworm, Veterinary
Administrations should require:
c) all animals have been prophylactically treated again by dipping or spraying as in point 2) above.
Article 2.2.8.2.
1. The floor of the quarantine area and the vehicles must be thoroughly sprayed with an officially
approved larvicide before and after each use.
2. The transit route must be the most direct, with no stopover without prior permission of the importing
country.
Article 2.2.8.3.
1. On arrival at the importation point, all animals must be thoroughly inspected for wounds and
possible new world or old world screwworm infestation under the supervision of an Official
Veterinarian.
2. The bedding material of the vehicle and the quarantine area should immediately be gathered and
burned following each consignment.
Article 2.2.8.4.
The larval stage of the new world or old world screwworm fly is dependent on live animals and cannot
survive for any length of time in dead tissue or animal products; therefore, restrictions on these products
are not considered necessary.
TRICHINELLOSIS
(Trichinella spiralis)
Article 2.2.9.1.
Article 2.2.9.2.
Article 2.2.9.3.
A country or zone may be considered free from trichinellosis in domestic swine when:
1. trichinellosis is notifiable in the country;
2. there is in force an effective disease reporting system shown to be capable of capturing the
occurrence of cases;
AND EITHER:
3. it has been ascertained that Trichinella infection does not exist in the domestic swine population of
the country or zone under consideration; this is established by the regular surveillance of the swine
population using an approved testing procedure, which provided negative results when:
a) within a 5-year period, a serological survey was conducted on a statistically based sample size
from within the slaughter sow population sufficient to provide at least 95% confidence of
detecting trichinellosis if it was present at a prevalence exceeding 0.02%, and
during this 5-year period, continuous testing was conducted on a statistically based sample size
from within the annual slaughter swine population sufficient to provide at least 95% confidence
of detecting trichinellosis if it is present at a prevalence exceeding 0.01%, following which:
b) a serological survey is carried out every third year on the slaughter sow population sufficient to
provide at least 95% confidence of detecting trichinellosis if it is present at a prevalence
exceeding 0.2%; during this time the number of samples in the slaughter swine population could
be reduced to detect at the 0.5% level on an annual basis;
OR
4. in the country or zone under consideration, the following conditions are met:
a) trichinellosis has not been reported in the domestic swine population for at least 5 years;
b) wild susceptible species are subjected to a regular surveillance programme, and no clinical,
serological or epidemiological evidence of trichinellosis has been found;
5. the regular surveillance described in point 3) above is carried out and should be concentrated where
infestation was last identified, and/or where the feeding of swill to swine occurs;
6. any suspicion of disease is followed at the field level by traceback, quarantine and laboratory testing;
7. if trichinellosis is confirmed, the infected premises remains under official veterinary control and is
subjected to disease control measures using a stamping-out policy and rodent control;
9. any human outbreaks of trichinellosis are investigated to determine the animal source.
Article 2.2.9.4.
Article 2.2.9.5.
the presentation of an international veterinary certificate attesting that the entire consignment of meat:
AND
3. has been processed to ensure the destruction of all the larvae of the parasite.
Article 2.2.10.1.
For the purposes of this Terrestrial Code, the incubation period for foot and mouth disease (FMD) shall be
14 days.
For the purposes of this Chapter, ruminants include animals of the family of Camelidae.
For the purposes of this Chapter, a case includes an animal infected with FMD virus (FMDV).
For the purposes of international trade, this Chapter deals not only with the occurrence of clinical signs
caused by FMDV, but also with the presence of infection with FMDV in the absence of clinical signs.
The following defines the occurrence of FMDV infection:
1. FMDV has been isolated and identified as such from an animal or a product derived from that
animal, or
2. viral antigen or viral RNA specific to one or more of the serotypes of FMDV has been identified in
samples from one or more animals showing clinical signs consistent with FMD, or epidemiologically
linked to a confirmed or suspected outbreak of FMD, or giving cause for suspicion of previous
association or contact with FMDV, or
3. antibodies to structural or nonstructural proteins of FMDV that are not a consequence of
vaccination, have been identified in one or more animals showing clinical signs consistent with
FMD, or epidemiologically linked to a confirmed or suspected outbreak of FMD, or giving cause for
suspicion of previous association or contact with FMDV.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.2.10.2.
To qualify for inclusion in the existing list of FMD free countries where vaccination is not practised, a
country should:
1. have a record of regular and prompt animal disease reporting;
2. send a declaration to the OIE stating that:
a) there has been no outbreak of FMD during the past 12 months;
b) no evidence of FMDV infection has been found during the past 12 months;
c) no vaccination against FMD has been carried out during the past 12 months,
and supply documented evidence that surveillance for both FMD and FMDV infection in
accordance with Appendix 3.8.7. is in operation and that regulatory measures for the prevention and
control of FMD have been implemented;
3. not have imported since the cessation of vaccination any animals vaccinated against FMD.
The country will be included in the list only after the submitted evidence has been accepted by the OIE.
Article 2.2.10.3.
To qualify for inclusion in the list of FMD free countries where vaccination is practised, a country should:
1. have a record of regular and prompt animal disease reporting;
2. send a declaration to the OIE that there has been no outbreak of FMD for the past 2 years and no
evidence of FMDV circulation for the past 12 months, with documented evidence that:
a) surveillance for FMD and FMDV circulation in accordance with Appendix 3.8.7. is in
operation, and that regulatory measures for the prevention and control of FMD have been
implemented;
b) routine vaccination is carried out for the purpose of the prevention of FMD;
c) the vaccine used complies with the standards described in the Terrestrial Manual.
The country will be included in the list only after the submitted evidence has been accepted by the OIE.
If an FMD free country where vaccination is practised wishes to change its status to FMD free country
where vaccination is not practised, the country should wait for 12 months after vaccination has ceased
and provide evidence showing that FMDV circulation has not occurred during that period.
Article 2.2.10.4.
An FMD free zone where vaccination is not practised can be established in either an FMD free country
where vaccination is practised or in a country of which parts are infected. Susceptible animals in the FMD
free zone should be separated from the rest of the country, if infected, and from neighbouring infected
countries by a buffer zone, or physical or geographical barriers, and animal health measures that effectively
prevent the entry of the virus should be implemented. A country in which an FMD free zone where
vaccination is not practised is to be established should:
1. have a record of regular and prompt animal disease reporting;
2. send a declaration to the OIE stating that it wishes to establish an FMD free zone where vaccination
is not practised and that:
a) there has been no outbreak of FMD during the past 12 months;
b) no evidence of FMDV infection has been found during the past 12 months;
c) no vaccination against FMD has been carried out during the past 12 months;
d) no vaccinated animal has been introduced into the zone since the cessation of vaccination,
except in accordance with Article 2.2.10.8.;
3. supply documented evidence that surveillance for both FMD and FMDV infection in accordance
with Appendix 3.8.7. is in operation in the FMD free zone where vaccination is not practised;
4. describe in detail:
a) regulatory measures for the prevention and control of both FMD and FMDV infection,
b) the boundaries of the FMD free zone and, if applicable, the buffer zone,
c) the system for preventing the entry of the virus (including the control of the movement of
susceptible animals) into the FMDV free zone (in particular if the procedure described in
Article 2.2.10.8. is implemented),
and supply documented evidence that these are properly implemented and supervised.
The free zone will be included in the list of FMD free zones where vaccination is not practised only after
the submitted evidence has been accepted by the OIE.
Article 2.2.10.5.
An FMD free zone where vaccination is practised can be established in either an FMD free country where
vaccination is not practised or in a country of which parts are infected. Susceptible animals in the free
zone where vaccination is practised should be separated from the rest of the country, if infected, and
from neighbouring infected countries by a buffer zone, or physical or geographical barriers, and animal
health measures that effectively prevent the entry of the virus should be implemented.
Vaccination of zoo animals, animals belonging to rare species or breeds, or animals in research centres as
a precaution for conservation purposes is an example of implementation of an FMD free zone or
compartment where vaccination is practised.
A country in which an FMD free zone where vaccination is practised is to be established should:
1. have a record of regular and prompt animal disease reporting;
2. send a declaration to the OIE that it wishes to establish an FMD free zone where vaccination is
practised, where there has been no outbreak of FMD for the past 2 years and no evidence of FMDV
circulation for the past 12 months, with documented evidence that surveillance for FMD and FMDV
circulation in accordance with Appendix 3.8.7. is in operation;
3. supply documented evidence that the vaccine used complies with the standards described in the
Terrestrial Manual;
4. describe in detail:
a) regulatory measures for the prevention and control of both FMD and FMDV circulation,
b) the boundaries of the FMD free zone where vaccination is practised and, if applicable, the buffer
zone,
c) the system for preventing the entry of the virus into the FMD free zone (in particular if the
procedure described in Article 2.2.10.8. is implemented),
and supply evidence that these are properly implemented and supervised;
5. supply documented evidence that it has a system of intensive and frequent surveillance for FMD in
the FMD free zone where vaccination is practised.
The free zone will be included in the list of FMD free zones where vaccination is practised only after the
submitted evidence has been accepted by the OIE.
If a country that has an FMD free zone where vaccination is practised wishes to change the status of the
zone to FMD free zone where vaccination is not practised, a waiting period of 12 months after
vaccination has ceased is required and evidence must be provided showing that FMDV infection has not
occurred in the said zone during that period
Article 2.2.10.6.
An FMD infected country is a country that does not fulfil the requirements to qualify as either an FMD
free country where vaccination is not practised or an FMD free country where vaccination is practised.
An FMD infected zone is a zone that does not fulfil the requirements to qualify as either an FMD free
zone where vaccination is not practised or an FMD free zone where vaccination is practised.
Article 2.2.10.7.
1. When an FMD outbreak or FMDV infection occurs in an FMD free country or zone where
vaccination is not practised, one of the following waiting periods is required to regain the status of
FMD free country or zone where vaccination is not practised:
a) 3 months after the last case where a stamping-out policy and serological surveillance are applied in
accordance with Appendix 3.8.7., or
b) 3 months after the slaughter of all vaccinated animals where a stamping-out policy, emergency
vaccination and serological surveillance are applied in accordance with Appendix 3.8.7., or
c) 6 months after the last case or the last vaccination (according to the event that occurs the latest),
where a stamping-out policy, emergency vaccination not followed by the slaughtering of all
vaccinated animals, and serological surveillance are applied in accordance with Appendix 3.8.7.,
provided that a serological survey based on the detection of antibodies to nonstructural proteins
of FMDV demonstrates the absence of infection in the remaining vaccinated population.
Where a stamping-out policy is not practised, Article 2.2.10.4. applies.
2. When an FMD outbreak or FMDV infection occurs in an FMD free country or zone where
vaccination is practised, one of the following waiting periods is required to regain the status of FMD
free country or zone where vaccination is practised:
a) 6 months after the last case where a stamping-out policy, emergency vaccination and serological
surveillance in accordance with Appendix 3.8.7. are applied, provided that the serological
surveillance based on the detection of antibodies to nonstructural proteins of FMDV
demonstrates the absence of virus circulation, or
b) 18 months after the last case where a stamping-out policy is not applied, but emergency vaccination
and serological surveillance in accordance with Appendix 3.8.7. are applied, provided that the
serological surveillance based on the detection of antibodies to nonstructural proteins of
FMDV demonstrates the absence of virus circulation.
Article 2.2.10.8.
Transfer directly to slaughter of FMD susceptible animals from an infected zone to a free zone
within a country
FMD susceptible animals should only leave the infected zone if moved by mechanised transport to the
nearest designated abattoir located in the buffer zone directly to slaughter.
In the absence of an abattoir in the buffer zone, live FMD susceptible animals can be transported to the
nearest abattoir in a free zone directly to slaughter only under the following conditions:
1. no FMD susceptible animal has been introduced into the establishment of origin and no animal in the
establishment of origin has shown clinical signs of FMD for at least 30 days prior to movement;
2. the animals were kept in the establishment of origin for at least 3 months prior to movement;
3. FMD has not occurred within a 10-kilometre radius of the establishment of origin for at least
3 months prior to movement;
4. the animals must be transported under the supervision of the Veterinary Authority in a vehicle, which
was cleansed and disinfected before loading, directly from the establishment of origin to the abattoir
without coming into contact with other susceptible animals;
5. such an abattoir is not approved for the export of fresh meat;
6. vehicles and the abattoir must be subjected to thorough cleansing and disinfection immediately after
use.
All products obtained from the animals and any products coming into contact with them must be
considered infected, and treated in such a way as to destroy any residual virus in accordance with
Appendix 3.6.2.
Animals moved into a free zone for other purposes must be moved under the supervision of the
Veterinary Authority and comply with the conditions in Article 2.2.10.11.
Article 2.2.10.9.
When importing from FMD free countries where vaccination is not practised or FMD free zones where
vaccination is not practised, Veterinary Administrations should require:
for FMD susceptible animals
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of FMD on the day of shipment;
2. were kept in an FMD free country or zone where vaccination is not practised since birth or for at
least the past 3 months.
Article 2.2.10.10.
When importing from FMD free countries where vaccination is practised or from FMD free zones where
vaccination is practised, Veterinary Administrations should require:
for domestic ruminants and pigs
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of FMD on the day of shipment;
2. were kept in an FMD free country since birth or for at least the past 3 months; and
3. have not been vaccinated and were subjected, with negative results, to tests for antibodies against
FMD virus, when destined to an FMD free country or zone where vaccination is not practised.
Article 2.2.10.11.
When importing from FMD infected countries or zones, Veterinary Administrations should require:
for domestic ruminants and pigs
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of FMD on the day of shipment;
2. were kept in the establishment of origin since birth, or
a) for the past 30 days, if a stamping-out policy is in force in the exporting country, or
b) for the past 3 months, if a stamping-out policy is not in force in the exporting country,
and that FMD has not occurred within a 10-kilometre radius of the establishment of origin for the
relevant period as defined in points a) and b) above; and
3. were isolated in an establishment for the 30 days prior to shipment, and all animals in isolation were
subjected to diagnostic tests (probang and serology) for evidence of FMDV infection with negative
results at the end of that period, and that FMD did not occur within a 10-kilometre radius of the
establishment during that period; or
4. were kept in a quarantine station for the 30 days prior to shipment, all animals in quarantine were
subjected to diagnostic tests (probang and serology) for evidence of FMDV infection with negative
results at the end of that period, and that FMD did not occur within a 10-kilometre radius of the
quarantine station during that period;
5. were not exposed to any source of FMD infection during their transportation from the quarantine
station to the place of shipment.
Article 2.2.10.12.
When importing from FMD free countries where vaccination is not practised or FMD free zones where
vaccination is not practised, Veterinary Administrations should require:
b) were kept in an FMD free country or zone where vaccination is not practised for at least
3 months prior to collection;
2. the semen was collected, processed and stored in conformity with the provisions of Appendix 3.2.1.
or Appendix 3.2.2., as relevant.
Article 2.2.10.13.
When importing from FMD free countries where vaccination is not practised or FMD free zones where
vaccination is not practised, Veterinary Administrations should require:
a) showed no clinical sign of FMD on the day of collection of the semen and for the following
30 days;
b) were kept in an FMD free country or zone where vaccination is not practised for at least
3 months prior to collection;
2. the semen was collected, processed and stored in conformity with the provisions of Appendix 3.2.1.
or Appendix 3.2.2., as relevant.
Article 2.2.10.14.
When importing from FMD free countries where vaccination is practised or from FMD free zones where
vaccination is practised, Veterinary Administrations should require:
Article 2.2.10.15.
When importing from FMD infected countries or zones, Veterinary Administrations should require:
for semen of domestic ruminants and pigs
the presentation of an international veterinary certificate attesting that:
1. the donor animals:
a) showed no clinical sign of FMD on the day of collection of the semen;
b) were kept in an establishment where no animal had been added in the 30 days before collection,
and that FMD has not occurred within 10 kilometres for the 30 days before and after collection;
c) have not been vaccinated and were subjected, not less than 21 days after collection of the
semen, to tests for antibodies against FMD virus, with negative results; or
d) had been vaccinated at least twice, with the last vaccination not more than 12 and not less than
one month prior to collection;
2. no other animal present in the artificial insemination centre has been vaccinated within the month prior
to collection;
3. the semen:
a) was collected, processed and stored in conformity with the provisions of Appendix 3.2.1. or
Appendix 3.2.2., as relevant.
b) was subjected, with negative results, to a test for FMDV infection if the donor animal has been
vaccinated within the 12 months prior to collection;
c) was stored in the country of origin for a period of at least one month following collection, and
during this period no animal on the establishment where the donor animals were kept showed
any sign of FMD.
Article 2.2.10.16.
Irrespective of the FMD status of the exporting country or zone, Veterinary Administrations should authorise
without restriction on account of FMD the import or transit through their territory of in vivo derived
embryos of cattle subject to the presentation of an international veterinary certificate attesting that the
embryos were collected, processed and stored in conformity with the provisions of Appendix 3.3.1. or
Appendix 3.3.3., as relevant.
Article 2.2.10.17.
When importing from FMD free countries where vaccination is not practised or FMD free zones where
vaccination is not practised, Veterinary Administrations should require:
for in vitro produced embryos of cattle
the presentation of an international veterinary certificate attesting that:
1. the donor females:
a) showed no clinical sign of FMD at the time of collection of the oocytes;
b) were kept in a country or zone free from FMD at the time of collection;
2. fertilisation was achieved with semen meeting the conditions referred to in Articles 2.2.10.12.,
2.2.10.13., 2.2.10.14. or 2.2.10.15., as relevant;
3. the oocytes were collected, and the embryos were processed and stored in conformity with the
provisions of Appendix 3.3.2. or Appendix 3.3.3., as relevant.
Article 2.2.10.18.
When importing from FMD free countries where vaccination is practised or from FMD free zones where
vaccination is practised, Veterinary Administrations should require:
for in vitro produced embryos of cattle
the presentation of an international veterinary certificate attesting that:
1. the donor females:
a) showed no clinical sign of FMD at the time of collection of the oocytes;
b) were kept in a country or zone free from FMD for at least 3 months prior to collection;
c) if destined for an FMD free country or zone where vaccination is not practised:
i) have not been vaccinated and were subjected, with negative results, to tests for antibodies
against FMD virus, or
ii) had been vaccinated at least twice, with the last vaccination not less than one month and
not more than 12 months prior to collection;
2. no other animal present in the establishment has been vaccinated within the month prior to collection;
3. fertilization was achieved with semen meeting the conditions referred to in
Articles 2.2.10.12., 2.2.10.13., 2.2.10.14. or 2.2.10.15., as relevant;
4. the oocytes were collected, and the embryos were processed and stored in conformity with the
provisions of Appendix 3.3.2. or Appendix 3.3.3., as relevant.
Article 2.2.10.19.
When importing from FMD free countries where vaccination is not practised or FMD free zones where
vaccination is not practised, Veterinary Administrations should require:
for fresh meat of FMD susceptible animals
the presentation of an international veterinary certificate attesting that the entire consignment of meat comes
from animals which:
1. have been kept in the FMD free country or zone where vaccination is not practised since birth, or
which have been imported in accordance with Article 2.2.10.9., Article 2.2.10.10. or Article 2.2.10.11.;
2. have been slaughtered in an approved abattoir and have been subjected to ante-mortem and
post-mortem inspections for FMD with favourable results.
Article 2.2.10.20.
When importing from FMD free countries where vaccination is practised or from FMD free zones where
vaccination is practised, Veterinary Administrations should require:
for fresh meat of cattle and buffalo (Bubalus bubalis) (excluding feet, head and viscera)
the presentation of an international veterinary certificate attesting that the entire consignment of meat comes
from animals which:
1. have been kept in the FMD free country or zone where vaccination is practised since birth, or which
have been imported in accordance with Article 2.2.10.9., Article 2.2.10.10. or Article 2.2.10.11.;
2. have been slaughtered in an approved abattoir and have been subjected to ante-mortem and
post-mortem inspections for FMD with favourable results.
Article 2.2.10.21.
When importing from FMD free countries where vaccination is practised or from FMD free zones where
vaccination is practised, Veterinary Administrations should require:
for fresh meat or meat products of pigs and ruminants other than cattle and buffalo
the presentation of an international veterinary certificate attesting that the entire consignment of meat comes
from animals which:
1. have been kept in the FMD free country or zone where vaccination is practised since birth, or which
have been imported in accordance with Article 2.2.10.9., Article 2.2.10.10. or Article 2.2.10.11.;
2. have been slaughtered in an approved abattoir and have been subjected to ante-mortem and
post-mortem inspections for FMD with favourable results.
Article 2.2.10.22.
When importing from FMD infected countries or zones, where an official control programme exists,
involving compulsory systematic vaccination of cattle, Veterinary Administrations should require:
for fresh meat of cattle and buffalo (Bubalus bubalis) (excluding feet, head and viscera)
the presentation of an international veterinary certificate attesting that the entire consignment of meat:
1. comes from animals which:
a) have remained in the exporting country for at least 3 months prior to slaughter;
b) have remained, during this period, in a part of the country where cattle are regularly vaccinated
against FMD and where official controls are in operation;
c) have been vaccinated at least twice with the last vaccination not more than 12 months and not
less than one month prior to slaughter;
d) were kept for the past 30 days in an establishment, and that FMD has not occurred within a
10-kilometre radius of the establishment during that period;
e) have been transported, in a vehicle which was cleansed and disinfected before the cattle were
loaded, directly from the establishment of origin to the approved abattoir without coming into
contact with other animals which do not fulfil the required conditions for export;
f) have been slaughtered in an approved abattoir:
i) which is officially designated for export;
ii) in which no FMD has been detected during the period between the last disinfection carried
out before slaughter and the shipment for export has been dispatched;
g) have been subjected to ante-mortem and post-mortem inspections for FMD with favourable
results within 24 hours before and after slaughter;
2. comes from deboned carcasses:
a) from which the major lymphatic nodes have been removed;
b) which, prior to deboning, have been submitted to maturation at a temperature above + 2°C for
a minimum period of 24 hours following slaughter and in which the pH value was below 6.0
when tested in the middle of both the longissimus dorsi.
Article 2.2.10.23.
When importing from FMD infected countries or zones, Veterinary Administrations should require:
for meat products of domestic ruminants and pigs
the presentation of an international veterinary certificate attesting that:
1. the entire consignment of meat comes from animals which have been slaughtered in an approved
abattoir and have been subjected to ante-mortem and post-mortem inspections for FMD with
favourable results;
2. the meat has been processed to ensure the destruction of the FMD virus in conformity with one of
the procedures referred to in Article 3.6.2.1.;
3. the necessary precautions were taken after processing to avoid contact of the meat products with any
potential source of FMD virus.
Article 2.2.10.24.
When importing from FMD free countries or zones (where vaccination either is or is not practised),
Veterinary Administrations should require:
for milk and milk products intended for human consumption and for products of animal origin (from
FMD susceptible animals) intended for use in animal feeding or for agricultural or industrial use
the presentation of an international veterinary certificate attesting that these products come from animals
which have been kept in the country or zone since birth, or which have been imported in accordance with
Article 2.2.10.9., Article 2.2.10.10. or Article 2.2.10.11.
Article 2.2.10.25.
When importing from FMD infected countries or zones where an official control programme exists,
Veterinary Administrations should require:
for milk, cream, milk powder and milk products
the presentation of an international veterinary certificate attesting that:
1. these products:
a) originate from herds or flocks which were not infected or suspected of being infected with
FMD at the time of milk collection;
b) have been processed to ensure the destruction of the FMD virus in conformity with one of the
procedures referred to in Article 3.6.2.5. and in Article 3.6.2.6.;
2. the necessary precautions were taken after processing to avoid contact of the products with any
potential source of FMD virus.
Article 2.2.10.26.
When importing from FMD infected countries, Veterinary Administrations should require:
for blood and meat-meals (from domestic or wild ruminants and pigs)
the presentation of an international veterinary certificate attesting that the manufacturing method for these
products included heating to a minimum internal temperature of 70°C for at least 30 minutes.
Article 2.2.10.27.
When importing from FMD infected countries, Veterinary Administrations should require:
for wool, hair, bristles, raw hides and skins (from domestic or wild ruminants and pigs)
the presentation of an international veterinary certificate attesting that:
1. these products have been processed to ensure the destruction of the FMD virus in conformity with
one of the procedures referred to in Article 3.6.2.2., Article 3.6.2.3. and Article 3.6.2.4.;
2. the necessary precautions were taken after collection or processing to avoid contact of the products
with any potential source of FMD virus.
Veterinary Administrations can authorise, without restriction, the import or transit through their territory
of semi-processed hides and skins (limed hides, pickled pelts, and semi-processed leather - e.g. wet blue
and crust leather), provided that these products have been submitted to the usual chemical and
mechanical processes in use in the tanning industry.
Article 2.2.10.28.
When importing from FMD infected countries or zones, Veterinary Administrations should require:
for straw and forage
the presentation of an international veterinary certificate attesting that these commodities:
1. are free of grossly identifiable contamination with material of animal origin:
2. have been subjected to one of the following treatments, which, in the case of material sent in bales,
has been shown to penetrate to the centre of the bale:
a) either to the action of steam in a closed chamber such that the centre of the bales has reached a
minimum temperature of 80°C for at least 10 minutes,
b) or to the action of formalin fumes (formaldehyde gas) produced by its commercial solution at
35-40% in a chamber kept closed for at least 8 hours and at a minimum temperature of 19°C;
OR
3. have been kept in bond for at least 3 months (under study) before being released for export.
Article 2.2.10.29.
When importing from FMD free countries or zones (where vaccination either is or is not practised),
Veterinary Administrations should require:
for skins and trophies derived from FMD susceptible wild animals
the presentation of an international veterinary certificate attesting that these products are derived from
animals that have been kept in such a country or zone since birth, or which have been imported from a
country or zone free of FMD (where vaccination either is or is not practised).
Article 2.2.10.30.
When importing from FMD infected countries or zones, Veterinary Administrations should require:
for skins and trophies derived from FMD susceptible wild animals
the presentation of an international veterinary certificate attesting that these products have been processed to
ensure the destruction of the FMD virus in conformity with the procedures referred to in Article 3.6.2.7.
1 [Note: International veterinary certificates for animal products coming from infected countries or zones
may not be required if the products are transported in an approved manner to premises controlled and
approved by the Veterinary Administration of the importing country for processing to ensure the
destruction of the FMD virus in conformity with the procedures referred to in Article 3.6.2.2.,
Article 3.6.2.3. and Article 3.6.2.4.]
VESICULAR STOMATITIS
Article 2.2.11.1.
For the purposes of this Terrestrial Code, the incubation period for vesicular stomatitis (VS) shall be 21 days.
Standards for diagnostic tests are described in the Terrestrial Manual.
Article 2.2.11.2.
VS free country
Article 2.2.11.3.
Veterinary Administrations of countries shall consider whether there is a risk with regard to VS in accepting
importation or transit through their territory, from other countries, of ruminants, swine, Equidae, and
their semen and embryos.
Article 2.2.11.4.
Article 2.2.11.5.
4. were protected from insect vectors during quarantine and transportation to the place of shipment.
Article 2.2.11.6.
When importing from countries considered infected with VS, Veterinary Administrations should require:
for domestic cattle, sheep, goats, pigs and horses
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of VS on the day of shipment;
2. were kept, since birth or for the past 21 days, in an establishment where no case of VS was officially
reported during that period; or
3. were kept in a quarantine station for the 30 days prior to shipment and were subjected to a diagnostic
test for VS with negative results at least 21 days after the commencement of quarantine;
4. were protected from insect vectors during quarantine and transportation to the place of shipment.
Article 2.2.11.7.
When importing from countries considered infected with VS, Veterinary Administrations should require:
for wild bovine, ovine, caprine, porcine and equine animals and deer
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of VS on the day of shipment;
2. were kept in a quarantine station for the 30 days prior to shipment and were subjected to a diagnostic
test for VS with negative results at least 21 days after the commencement of quarantine;
3. were protected from insect vectors during quarantine and transportation to the place of shipment.
Article 2.2.11.8.
When importing from VS free countries or zones, Veterinary Administrations should require:
for in vivo derived embryos of ruminants, swine and horses
Article 2.2.11.9.
When importing from countries or zones considered infected with VS, Veterinary Administrations should
require:
RINDERPEST
Article 2.2.12.1.
For the purposes of this Terrestrial Code, the incubation period for rinderpest shall be 21 days.
Ban on vaccination against rinderpest means a ban on administering a rinderpest vaccine to any
susceptible species and a heterologous vaccine against rinderpest to any large ruminants or pigs.
1. Animal not vaccinated against rinderpest means:
a) for large ruminants and pigs: an animal that has received neither a rinderpest vaccine nor a
heterologous vaccine against rinderpest.
b) for small ruminants: an animal that has not received a rinderpest vaccine.
2. The following defines the occurrence of rinderpest virus infection:
a) rinderpest virus has been isolated and identified as such from an animal or a product derived
from that animal, or
b) viral antigen or viral RNA specific to rinderpest has been identified in samples from one or
more animals showing one or more clinical signs consistent with rinderpest, or
epidemiologically linked to an outbreak of rinderpest, or giving cause for suspicion of association
or contact with rinderpest, or
c) antibodies to rinderpest virus antigens which are not the consequence of vaccination, have been
identified in one or more animals with either epidemiological links to a confirmed or suspected
outbreak of rinderpest in domestic or wild animals, or showing clinical signs consistent with
recent infection with rinderpest.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.2.12.2.
To be considered free from infection, a country should meet the requirements contained in
Appendix 3.8.2.
Should a localised rinderpest outbreak occur in an infection free country, the waiting period before
infection free status can be regained shall be as follows:
1. 6 months after the last case where stamping-out without vaccination and serological surveillance are
applied; or
2. 6 months after the slaughtering of the last vaccinated animal where stamping-out complemented by
emergency vaccination (vaccinated animals should be clearly identified with a permanent mark) and
serological surveillance are applied; or
3. 12 months after the last case or last vaccination (whichever occurs later) where emergency vaccination
without slaughter (vaccinated animals should be clearly identified with a permanent mark) and
serological surveillance are applied.
Article 2.2.12.3.
To be considered free from the disease, a country or a zone should meet the requirements contained in
Appendix 3.8.2.
Article 2.2.12.4.
To be considered provisionally free from the disease, a country or a zone should meet the requirements
contained in Appendix 3.8.2.
Article 2.2.12.5.
When the requirements for acceptance as an infection free country, a disease free country or zone, or a
provisionally free country or zone are not fulfilled, a country or zone shall be considered as infected.
Article 2.2.12.6.
Veterinary Administrations of countries shall consider whether there is a risk with regard to rinderpest in
accepting importation or transit through their territory, from other countries, of the following commodities:
1. ruminants and swine;
2. semen of ruminants and swine;
3. embryos/ova of ruminants and swine;
4. products of animal origin (from ruminants and swine);
5. pathological material and biological products (see Chapter 1.4.5. and Section 1.5.).
For the purposes of this Chapter, ruminants include animals of the family of Camelidae.
Article 2.2.12.7.
When importing from infection free countries, Veterinary Administrations should require:
for ruminants and swine
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of rinderpest on the day of shipment;
2. remained in an infection free country since birth or for at least 30 days prior to shipment.
Article 2.2.12.8.
When importing from disease free countries or zones, Veterinary Administrations should require:
for domestic ruminants and swine, and wild ruminants and swine reared under confined conditions
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of rinderpest on the day of shipment;
2. were kept in a disease free country or zone since birth or for at least the past 3 months;
3. have not been vaccinated against rinderpest;
4. were kept isolated in their establishment of origin for the 30 days prior to shipment and were
subjected to a diagnostic test for rinderpest on two occasions with negative results, at an interval of
not less than 21 days;
5. were not exposed to any source of infection during their transportation from the establishment of
origin to the place of shipment.
Article 2.2.12.9.
When importing from disease free countries or zones, Veterinary Administrations should require:
for wild ruminants and swine not reared under confined conditions
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of rinderpest on the day of shipment;
2. come from a disease free country or zone;
3. have not been vaccinated against rinderpest;
4. were kept in a quarantine station for the 30 days prior to shipment and were subjected to a diagnostic
test for rinderpest on two occasions with negative results, at an interval of not less than 21 days;
5. were not exposed to any source of infection during their transportation from the quarantine station to
the place of shipment.
Article 2.2.12.10.
When importing from provisionally free countries or zones, Veterinary Administrations should require:
for domestic ruminants and swine, and wild ruminants and swine reared under confined conditions
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of rinderpest on the day of shipment;
2. were kept in the establishment of origin since birth or for at least 21 days before introduction into the
quarantine station referred to in point 3) below;
3. have not been vaccinated against rinderpest, were isolated in a quarantine station for the 30 days prior
to shipment, and were subjected to a diagnostic test for rinderpest on two occasions with negative
results, at an interval of not less than 21 days.
Article 2.2.12.11.
When importing from infected countries or zones, Veterinary Administrations should require:
for domestic ruminants and swine, and wild ruminants and swine reared under confined conditions
the presentation of an international veterinary certificate attesting that:
1. in the country or zone, routine vaccination is carried out for the purpose of the prevention of
rinderpest;
2. rinderpest has not occurred within a 10-kilometre radius of the establishment of origin of the animals
destined for export for at least 21 days prior to their shipment to the quarantine station referred to in
point 3)b) below;
3. the animals:
a) showed no clinical sign of rinderpest on the day of shipment;
b) were kept in the establishment of origin since birth or for at least 21 days before introduction into
the quarantine station referred to in point c) below;
c) have not been vaccinated against rinderpest, were isolated in a quarantine station for the 30 days
prior to shipment, and were subjected to a diagnostic test for rinderpest on two occasions with
negative results, at an interval of not less than 21 days;
d) were not exposed to any source of infection during their transportation from the quarantine
station to the place of shipment;
4. rinderpest has not occurred within a 10-kilometre radius of the quarantine station for 30 days prior to
shipment.
Article 2.2.12.12.
When importing from disease or infection free countries, or from disease free zones, Veterinary
Administrations should require:
for semen of domestic ruminants and swine
the presentation of an international veterinary certificate attesting that:
1. the donor animals:
a) showed no clinical sign of rinderpest on the day of collection of the semen;
b) were kept in a disease or infection free country, or disease free zone, for at least 3 months prior
to collection;
2. the semen was collected, processed and stored in conformity with the provisions of either
Appendix 3.2.1. or Appendix 3.2.2., as relevant.
Article 2.2.12.13.
When importing from provisionally free countries or zones, Veterinary Administrations should require:
for semen of domestic ruminants and swine
the presentation of an international veterinary certificate attesting that:
1. the donor animals:
a) showed no clinical sign of rinderpest on the day of collection of the semen;
b) were vaccinated against rinderpest before the ban referred to in point 3)a) of Appendix 3.8.2.; or
c) have not been vaccinated against rinderpest, and were subjected to a diagnostic test for
rinderpest on two occasions with negative results, at an interval of not less than 21 days within
the 30 days prior to collection;
2. the semen was collected, processed and stored in conformity with the provisions of either
Appendix 3.2.1. or Appendix 3.2.2., as relevant.
Article 2.2.12.14.
When importing from infected countries or zones, Veterinary Administrations should require:
for semen of domestic ruminants and swine
the presentation of an international veterinary certificate attesting that:
1. in the country or zone, routine vaccination is carried out for the purpose of the prevention of
rinderpest;
2. the donor animals:
a) showed no clinical sign of rinderpest on the day of collection of the semen;
b) were kept in an establishment where no rinderpest susceptible animals had been added in the
21 days before collection, and that rinderpest has not occurred within 10 kilometres of the
establishment for the 21 days before and after collection;
c) were vaccinated against rinderpest for at least 3 months prior to collection; or
d) have not been vaccinated against rinderpest, and were subjected to a diagnostic test for
rinderpest on two occasions with negative results, at an interval of not less than 21 days within
the 30 days prior to collection;
3. the semen was collected, processed and stored in conformity with the provisions of either
Appendix 3.2.1. or Appendix 3.2.2., as relevant.
Article 2.2.12.15.
When importing from disease or infection free countries, or from disease free zones, Veterinary
Administrations should require:
for in vivo derived embryos of domestic ruminants and swine
the presentation of an international veterinary certificate attesting that:
1. the donor females were kept in an establishment located in a disease or infection free country, or in a
disease free zone, at the time of collection;
2. the embryos were collected, processed and stored in conformity with the provisions of
Appendix 3.3.1. or Appendix 3.3.3., as relevant.
Article 2.2.12.16.
When importing from provisionally free countries or zones, Veterinary Administrations should require:
for in vivo derived embryos of domestic ruminants and swine
the presentation of an international veterinary certificate attesting that:
1. the donor females:
a) showed no clinical sign of rinderpest at the time of collection and for the following 21 days;
b) were kept in an establishment where no rinderpest susceptible animals had been added in the
21 days before collection of the embryos;
c) were vaccinated against rinderpest before the ban referred to in point 3a) of Appendix 3.8.2.; or
d) have not been vaccinated against rinderpest, and were subjected to a diagnostic test for
rinderpest on two occasions with negative results, at an interval of not less than 21 days within
the 30 days prior to collection;
2. the embryos were collected, processed and stored in conformity with the provisions of
Appendix 3.3.1. or Appendix 3.3.3., as relevant.
Article 2.2.12.17.
When importing from infected countries or zones, Veterinary Administrations should require:
for in vivo derived embryos of domestic ruminants and swine
the presentation of an international veterinary certificate attesting that:
1. in the country or zone, routine vaccination is carried out for the purpose of the prevention of
rinderpest;
2. the donor females:
a) and all other animals in the establishment showed no clinical sign of rinderpest at the time of
collection and for the following 21 days;
b) were kept in an establishment where no rinderpest susceptible animals had been added in the
21 days before collection of the embryos;
c) were vaccinated against rinderpest for at least 3 months prior to collection; or
d) have not been vaccinated against rinderpest, and were subjected to a diagnostic test for
rinderpest on two occasions with negative results, at an interval of not less than 21 days within
the 30 days prior to collection;
3. the embryos were collected, processed and stored in conformity with the provisions of
Appendix 3.3.1. or Appendix 3.3.3., as relevant.
Article 2.2.12.18.
When importing from infection free countries, Veterinary Administrations should require:
for fresh meat or meat products of ruminants and swine
the presentation of an international veterinary certificate attesting that the entire consignment comes from
animals which have been kept in the country since birth or for at least 3 months prior to slaughter.
Article 2.2.12.19.
When importing from disease free countries or zones, Veterinary Administrations should require:
for fresh meat or meat products of domestic ruminants and swine
the presentation of an international veterinary certificate attesting that:
1. the entire consignment comes from animals which have been kept in the country or zone since birth
or for at least 3 months prior to slaughter;
2. the animals were slaughtered in an approved abattoir located in a disease free zone.
Article 2.2.12.20.
When importing from provisionally free countries or zones, Veterinary Administrations should require:
Article 2.2.12.21.
When importing from infected countries or zones, Veterinary Administrations should require:
for fresh meat (excluding offal) of domestic ruminants and swine
the presentation of an international veterinary certificate attesting that the entire consignment of meat:
1. comes from a country or zone where routine vaccination is carried out for the purpose of the
prevention of rinderpest;
2. comes from animals which:
a) showed no clinical sign of rinderpest within 24 hours before slaughter;
b) have remained in the country or zone for at least 3 months prior to slaughter;
c) were kept in the establishment of origin since birth or for at least 30 days prior to shipment to the
approved abattoir, and that rinderpest has not occurred within a 10-kilometre radius of the
establishment during that period;
d) were vaccinated against rinderpest at least 3 months prior to shipment to the approved abattoir;
e) had been transported, in a vehicle which was cleansed and disinfected before the animals were
loaded, directly from the establishment of origin to the approved abattoir without coming into
contact with other animals which do not fulfil the required conditions for export;
f) were slaughtered in an approved abattoir in which no rinderpest has been detected during the
period between the last disinfection carried out before slaughter and the date on which the
shipment has been dispatched;
3. comes from deboned carcasses from which the major lymphatic glands have been removed.
Article 2.2.12.22.
When importing from provisionally free countries or zones, or from infected countries or zones,
Veterinary Administrations should require:
for meat products of domestic ruminants and swine
the presentation of an international veterinary certificate attesting that:
1. only fresh meat complying with the provisions of Article 2.2.12.20. or Article 2.2.12.21., as relevant,
has been used in the preparation of the meat products; or
2. the meat products have been processed to ensure the destruction of the rinderpest virus in conformity
with one of the procedures referred to in Article 3.6.2.1.;
3. the necessary precautions were taken after processing to avoid contact of the meat products with any
possible source of rinderpest virus.
Article 2.2.12.23.
When importing from infection free countries, or from disease free countries or zones, Veterinary
Administrations should require:
for milk and milk products intended for human consumption and for products of animal origin (from
rinderpest susceptible animals) intended for use in animal feeding or for agricultural or industrial use
the presentation of an international veterinary certificate attesting that these products come from animals
which have been kept in the country or zone since birth or for at least 3 months.
Article 2.2.12.24.
When importing from provisionally free countries or zones, or from infected countries or zones,
Veterinary Administrations should require:
for milk and cream
the presentation of an international veterinary certificate attesting that:
1. these products:
a) originate from herds or flocks which were not subjected to any restrictions due to rinderpest at
the time of milk collection;
b) have been processed to ensure the destruction of the rinderpest virus in conformity with one of
the procedures referred to in Article 3.6.2.5. and in Article 3.6.2.6.;
2. the necessary precautions were taken after processing to avoid contact of the products with any
potential source of rinderpest virus.
Article 2.2.12.25.
When importing from provisionally free countries or zones, or from infected countries or zones,
Veterinary Administrations should require:
for milk products
the presentation of an international veterinary certificate attesting that:
1. these products are derived from milk complying with the above requirements;
2. the necessary precautions were taken after processing to avoid contact of the milk products with a
potential source of rinderpest virus.
Article 2.2.12.26.
When importing from provisionally free countries or zones, or from infected countries or zones,
Veterinary Administrations should require:
for blood and meat-meals (from domestic or wild ruminants and swine)
the presentation of an international veterinary certificate attesting that the manufacturing method for these
products included heating to a minimum internal temperature of 70°C for at least 30 minutes.
Article 2.2.12.27.
When importing from provisionally free countries or zones, or from infected countries or zones,
Veterinary Administrations should require:
for wool, hair, bristles, raw hides and skins (from domestic or wild ruminants and swine)
the presentation of an international veterinary certificate attesting that:
1. these products have been processed to ensure the destruction of the rinderpest virus in conformity
with one of the procedures referred to in Article 3.6.2.2., Article 3.6.2.3. and Article 3.6.2.4.;
2. the necessary precautions were taken after processing to avoid contact of the products with any
potential source of rinderpest virus.
Veterinary Administrations can authorise, without restriction, the import or transit through their territory
of semi-processed hides and skins (limed hides, pickled pelts, and semi-processed leather -e.g. wet blue
and crust leather), provided that these products have been submitted to the usual chemical and
mechanical processes in use in the tanning industry.
Article 2.2.12.28.
When importing from provisionally free countries or zones, or from infected countries or zones,
Veterinary Administrations should require:
for hooves, claws, bones and horns, hunting trophies and preparations destined for museums (from
domestic or wild ruminants and swine)
the presentation of an international veterinary certificate attesting that these products:
1. were completely dried and had no trace on them of skin, flesh or tendon; and/or
2. have been adequately disinfected.
1 [Note: International veterinary certificates for animal products coming from provisionally free countries
or zones, or infected countries or zones, may not be required if the products are transported in an approved
manner to premises controlled and approved by the Veterinary Administration of the importing
country for processing to ensure the destruction of the rinderpest virus as described in Article 3.6.2.2.,
Article 3.6.2.3. and Article 3.6.2.4.]
BLUETONGUE
Article 2.2.13.1.
For the purposes of the Terrestrial Code, the infective period for bluetongue virus (BTV) shall be 60 days.
The global BTV distribution is currently between latitudes of approximately 50°N and 35°S but is known
to be expanding in the northern hemisphere.
In the absence of clinical disease in a country or zone within this part of the world, its BTV status should
be determined by an ongoing surveillance and monitoring programme (in accordance with
Appendix 3.8.1.) designed in accordance with the epidemiology of the disease, i.e. focusing on climatic
and geographical factors, the biology and likely competence of Culicoides and/or serology of susceptible
animals. The programme may need to be adapted to target parts of the country or zone at a higher risk
due to historical, geographical and climatic factors, ruminant population data and Culicoides ecology, or
proximity to enzootic or incursional zones as described in 3.8.1.
All countries or zones adjacent to a country or zone not having free status should be subjected to similar
surveillance. The surveillance should be carried out over a distance of at least 100 kilometres from the
border with that country or zone, but a lesser distance could be acceptable if there are relevant ecological
or geographical features likely to interrupt the transmission of BTV.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.2.13.2.
1. A country or a zone may be considered free from BTV when bluetongue is notifiable in the whole
country and either:
a) the country or zone lies wholly north of 50°N or south of 35°S, and is not adjacent to a country
or zone not having a free status; or
b) a surveillance and monitoring programme in accordance with Appendix 3.8.1. has demonstrated
no evidence of BTV in the country or zone during the past 2 years; or
c) a surveillance and monitoring programme has demonstrated no evidence of Culicoides likely to
be competent BTV vectors in the country or zone.
2. A BTV free country or zone in which surveillance and monitoring has found no evidence that
Culicoides likely to be competent BTV vectors are present will not lose its free status through the
importation of vaccinated, seropositive or infective animals, or semen or embryos/ova from infected
countries or zones.
3. A BTV free country or zone in which surveillance and monitoring has found evidence that Culicoides
likely to be competent BTV vectors are present will not lose its free status through the importation
of vaccinated or seropositive animals from infected countries or zones, provided:
a) the animals have been vaccinated in accordance with the Terrestrial Manual at least 60 days prior
to dispatch with a vaccine which covers all serotypes whose presence in the source population
has been demonstrated through a surveillance and monitoring programme in accordance with
Appendix 3.8.1., and that the animals are identified in the accompanying certification as having
been vaccinated; or
b) the animals are not vaccinated, and a surveillance and monitoring programme in accordance
with Appendix 3.8.1. has been in place in the source population for a period of 60 days
immediately prior to dispatch, and no evidence of BTV transmission has been detected.
4. A BTV free country or zone adjacent to an infected country or zone should include a zone in which
surveillance is conducted in accordance with Appendix 3.8.1. Animals within this zone must be
subjected to continuing surveillance. The boundaries of this zone must be clearly defined, and must
take account of geographical and epidemiological factors that are relevant to BTV transmission.
Article 2.2.13.3.
A BTV seasonally free zone is a part of an infected country or zone for which for part of a year,
surveillance and monitoring demonstrate no evidence either of BTV transmission or of adult Culicoides
likely to be competent BTV vectors.
For the application of Articles 2.2.13.7., 2.2.13.10. and 2.2.13.14., the seasonally free period is taken to
commence the day following the last evidence of BTV transmission (as demonstrated by the surveillance
and monitoring programme), or of the cessation of activity of adult Culicoides likely to be competent BTV
vectors.
For the application of Articles 2.2.13.7., 2.2.13.10. and 2.2.13.14., the seasonally free period is taken to
conclude either:
1. at least 28 days before the earliest date that historical data show bluetongue virus activity has
recommenced; or
2. immediately if current climatic data or data from a surveillance and monitoring programme indicate
an earlier resurgence of activity of adult Culicoides likely to be competent BTV vectors.
A BTV seasonally free zone in which surveillance and monitoring has found no evidence that Culicoides
likely to be competent BTV vectors are present will not lose its free status through the importation of
vaccinated, seropositive or infective animals, or semen or embryos/ova from infected countries or zones.
Article 2.2.13.4.
A BTV infected country or zone is a clearly defined area where evidence of BTV has been reported
during the past 2 years.
Article 2.2.13.5.
Veterinary Administrations of countries shall consider whether there is a risk with regard to BTV infection
in accepting importation or transit through their territory, from other countries, of the following
commodities:
1. ruminants and other BTV susceptible herbivores;
2. semen of these species;
3. embryos/ova of these species;
4. pathological material and biological products (from these species) (see Chapter 1.4.5. and Section 1.5.).
Other commodities should be considered as not having the potential to spread BTV when they are the
subject of international trade.
Article 2.2.13.6.
When importing from BTV free countries or zones, Veterinary Administrations should require:
for ruminants and other BTV susceptible herbivores
the presentation of an international veterinary certificate attesting that:
1. the animals were kept in a BTV free country or zone since birth or for at least 60 days prior to
shipment; or
2. the animals were kept in a BTV free country or zone for at least 28 days, then were subjected, with
negative results, to a serological test to detect antibody to the BTV group according to the Terrestrial
Manual and remained in the BTV free country or zone until shipment; or
3. the animals were kept in a BTV free country or zone for at least 7 days, then were subjected, with
negative results, to an agent identification test according to the Terrestrial Manual, and remained in
the BTV free country or zone until shipment; or
4. the animals:
a) were kept in a BTV free country or zone for at least 7 days;
b) were vaccinated in accordance with the Terrestrial Manual 60 days before introduction into the
free country or zone against all serotypes whose presence in the source population has been
demonstrated through a surveillance and monitoring programme as described in
Appendix 3.8.1.;
c) were identified as having been vaccinated; and
d) remained in the BTV free country or zone until shipment;
AND
5. if the animals were exported from a free zone, either:
a) did not transit through an infected zone during transportation to the place of shipment; or
b) were protected from attack from Culicoides likely to be competent BTV vectors at all times
when transiting through an infected zone; or
c) had been vaccinated in accordance with point 4) above.
Article 2.2.13.7.
When importing from BTV seasonally free zones, Veterinary Administrations should require:
for ruminants and other BTV susceptible herbivores
the presentation of an international veterinary certificate attesting that the animals:
1. were kept during the seasonally free period in a BTV seasonally free zone for at least 60 days prior to
shipment; or
2. were kept during the BTV seasonally free period in a BTV seasonally free zone for at least 28 days
prior to shipment, and were subjected during the residence period in the zone to a serological test to
detect antibody to the BTV group according to the Terrestrial Manual, with negative results, carried
out at least 28 days after the commencement of the residence period; or
3. were kept during the BTV seasonally free period in a BTV seasonally free zone for at least 14 days
prior to shipment, and were subjected during the residence period in the zone to an agent
identification test according to the Terrestrial Manual, with negative results, carried out at least
14 days after the commencement of the residence period; or
4. were kept during the seasonally free period in a BTV seasonally free zone, and were vaccinated in
accordance with the Terrestrial Manual 60 days before introduction into the free country or zone
against all serotypes whose presence in the source population has been demonstrated through a
surveillance and monitoring programme in accordance with Appendix 3.8.1., were identified as
having been vaccinated and remained in the BTV free country or zone until shipment;
AND
5. if the animals were exported from a free zone, either:
a) did not transit through an infected zone during transportation to the place of shipment, or
b) were protected from attack from Culicoides likely to be competent BTV vectors at all times
when transiting through an infected zone; or
c) were vaccinated in accordance with point 4) above.
Article 2.2.13.8.
When importing from BTV infected countries or zones, Veterinary Administrations should require:
for ruminants and other BTV susceptible herbivores
the presentation of an international veterinary certificate attesting that the animals:
1. were protected from attack from Culicoides likely to be competent BTV vectors for at least 60 days
prior to shipment; or
2. were protected from attack from Culicoides likely to be competent BTV vectors for at least 28 days
prior to shipment, and were subjected during that period to a serological test according to the
Terrestrial Manual to detect antibody to the BTV group, with negative results, carried out at least
28 days after introduction into the quarantine station; or
3. were protected from attack from Culicoides likely to be competent BTV vectors for at least 14 days
prior to shipment, and were subjected during that period to an agent identification test according to
the Terrestrial Manual, with negative results, carried out at least 14 days after introduction into the
quarantine station; or
4. were vaccinated in accordance with the Terrestrial Manual at least 60 days before shipment, against all
serotypes whose presence in the source population has been demonstrated through a surveillance
and monitoring programme in accordance with Appendix 3.8.1., and were identified in the
accompanying certification as having been vaccinated; or
5. are not vaccinated, a surveillance and monitoring programme in accordance with Appendix 3.8.1. has
been in place in the source population for a period of 60 days immediately prior to shipment, and no
evidence of BTV transmission has been detected;
AND
6. were protected from attack from Culicoides likely to be competent BTV vectors during transportation
to the place of shipment; or
7. were vaccinated 60 days before shipment or had antibodies against all serotypes whose presence in
the zones of transit has been demonstrated through a surveillance and monitoring programme in
accordance with Appendix 3.8.1.
Article 2.2.13.9.
When importing from BTV free countries or zones, Veterinary Administrations should require:
Article 2.2.13.10.
When importing from BTV seasonally free zones, Veterinary Administrations should require:
for semen of ruminants and other BTV susceptible herbivores
the presentation of an international veterinary certificate attesting that:
1. the donor animals:
a) were kept during the BTV seasonally free period in a seasonally free zone for at least 60 days
before commencement of, and during, collection of the semen; or
b) were subjected to a serological test according to the Terrestrial Manual to detect antibody to the
BTV group, with negative results, at least every 60 days throughout the collection period and
between 21 and 60 days after the final collection for this consignment; or
c) were subjected to an agent identification test according to the Terrestrial Manual on blood
samples collected at commencement and conclusion of, and at least every 7 days (virus isolation
test) or at least every 28 days (PCR test) during, semen collection for this consignment, with
negative results;
2. the semen was collected, processed and stored in conformity with the provisions of Appendix 3.2.1.
Article 2.2.13.11.
When importing from BTV infected countries or zones, Veterinary Administrations should require:
for semen of ruminants and other BTV susceptible herbivores
the presentation of an international veterinary certificate attesting that:
1. the donor animals:
a) were protected from attack from Culicoides likely to be competent BTV vectors for at least
60 days before commencement of, and during, collection of the semen; or
b) were subjected to a serological test according to the Terrestrial Manual to detect antibody to the
BTV group, with negative results, at least every 60 days throughout the collection period and
between 21 and 60 days after the final collection for this consignment; or
c) were subjected to an agent identification test according to the Terrestrial Manual on blood
samples collected at commencement and conclusion of, and at least every 7 days (virus isolation
test) or at least every 28 days (PCR test) during, semen collection for this consignment, with
negative results;
2. the semen was collected, processed and stored in conformity with the provisions of Appendix 3.2.1.
Article 2.2.13.12.
Regardless of the bluetongue status of the exporting country, Veterinary Administrations of importing countries
should require:
for in vivo derived bovine embryos/oocytes
the presentation of an international veterinary certificate attesting that the embryos/oocytes were collected,
processed and stored in conformity with the provisions of Appendix 3.3.1. or Appendix 3.3.3., as
relevant.
Article 2.2.13.13.
When importing from BTV free countries or zones, Veterinary Administrations should require:
for in vivo derived embryos of ruminants (other than bovines) and other BTV susceptible herbivores
the presentation of an international veterinary certificate attesting that:
1. the donor females:
a) were kept in a BTV free country or zone for at least the 60 days prior to, and at the time of,
collection of the embryos; or
b) were subjected to a serological test according to the Terrestrial Manual to detect antibody to the
BTV group, between 21 and 60 days after collection, with negative results; or
c) were subjected to an agent identification test according to the Terrestrial Manual on a blood
sample taken on the day of collection, with negative results;
2. the embryos were collected, processed and stored in conformity with the provisions of
Appendix 3.3.1.
Article 2.2.13.14.
When importing from BTV seasonally free zones, Veterinary Administrations should require:
for in vivo derived embryos/oocytes of ruminants (other than bovines) and other BTV susceptible
herbivores and for in vitro produced bovine embryos
the presentation of an international veterinary certificate attesting that:
1. the donor females:
a) were kept during the seasonally free period in a seasonally free zone for at least 60 days before
commencement of, and during, collection of the embryos/oocytes; or
b) were subjected to a serological test according to the Terrestrial Manual to detect antibody to the
BTV group, between 21 and 60 days after collection, with negative results; or
c) were subjected to an agent identification test according to the Terrestrial Manual on a blood
sample taken on the day of collection, with negative results;
2. the embryos/oocytes were collected, processed and stored in conformity with the provisions of
Appendix 3.3.1.
Article 2.2.13.15.
When importing from BTV infected countries or zones, Veterinary Administrations should require:
for in vivo derived embryos/oocytes of ruminants (other than bovines) and other BTV susceptible
herbivores and for in vitro produced bovine embryos
a) were protected from attack from Culicoides likely to be competent BTV vectors for at least
60 days before commencement of, and during, collection of the embryos/oocytes; or
b) were subjected to a serological test according to the Terrestrial Manual to detect antibody to the
BTV group, between 21 and 60 days after collection, with negative results; or
c) were subjected to an agent identification test according to the Terrestrial Manual on a blood
sample taken on the day of collection, with negative results;
2. the embryos/oocytes were collected, processed and stored in conformity with the provisions of
Appendix 3.3.1.
Article 2.2.13.16.
When transporting animals through BTV infected countries or zones, Veterinary Administrations should
require strategies to protect animals from attack from Culicoides likely to be competent BTV vectors
during transport, taking into account the local ecology of the vector.
2. loading, transporting and unloading animals at times of low vector activity (i.e. bright sunshine, low
temperature);
3. ensuring vehicles do not stop en route during dawn or dusk, or overnight, unless the animals are held
behind insect proof netting;
4. darkening the interior of the vehicle, for example by covering the roof and/or sides of vehicles with
shadecloth;
5. monitoring for vectors at common stopping and offloading points to gain information on seasonal
variations;
6. using historical, ongoing and/or BTV modelling information to identify low risk ports and transport
routes.
Article 2.2.14.1.
For the purposes of this Terrestrial Code, the infective period for Rift Valley fever (RVF) shall be 30 days.
The historic distribution of RVF is the sub-Saharian African continent, Madagascar and the Arabian
Peninsula.
Countries or zones within the historic distribution of RVF or adjacent to those that are historically
infected should be subjected to surveillance.
Epidemics of RVF may occur in infected areas after flooding. They are separated by inter-epidemic
periods that may last for several decades in arid areas and, during these periods, the prevalence of
infection in humans, animals and mosquitoes can be difficult to detect.
In the absence of clinical disease, the RVF status of a country or zone within the historically infected
regions of the world should be determined by a surveillance and monitoring programme (carried out in
accordance with Appendix 3.8.1.) focusing on mosquitoes and serology of susceptible mammals. The
programme should concentrate on parts of the country or zone at high risk because of historical,
geographic and climatic factors, ruminant and mosquito population distribution, and proximity to areas
where epidemics have recently occurred.
Article 2.2.14.2.
A country or a zone may be considered free from RVF infection when the disease is notifiable in animals
throughout the country and either:
1. the country or zone lies outside the historically infected regions, and not adjacent to historically
infections; or
The provisions of the last paragraph of Article 2.2.14.1. may need to be complied with on a continuous
basis in order to maintain freedom from infection, depending on the geographical location of the country
or zone.
A RVF infection free country or zone in which surveillance and monitoring has found no evidence that
RVF infection is present will not lose its free status through the importation of permanently marked
seropositive animals or those destined for direct slaughter.
Article 2.2.14.3.
A RVF disease free country or zone is a country or zone that is not infection free (see Article 2.2.14.2.)
but in which disease has not occurred in humans or animals in the past 6 months provided that climatic
changes predisposing to outbreaks of RVF have not occurred during this time.
Article 2.2.14.4.
A RVF infected country or zone with disease is one in which clinical disease in humans or animals has
occurred within the past 6 months.
Article 2.2.14.5.
Veterinary Administrations of countries shall consider whether there is a risk with regard to RVF infection
in accepting importation or transit through their territory from other countries of the following
commodities:
1. live ruminants;
2. meat and meat products of domestic and wild ruminants.
Other commodities should be considered as not having the potential to spread RVF when they are the
subject of international trade.
Article 2.2.14.6.
When importing from RVF infection free countries or zones, Veterinary Administrations should require:
for ruminants
the presentation of an international veterinary certificate attesting that the animals:
1. were kept in a RVF free country or zone since birth or for at least 30 days prior to shipment, and
2. if the animals were exported from a free zone, either:
a) did not transit through an infected zone during transportation to the place of shipment; or
b) were protected from mosquito attack at all times when transiting through an infected zone.
Article 2.2.14.7.
When importing from RVF infection free countries or zones, Veterinary Administrations should require:
for meat and meat products of domestic and wild ruminants
the presentation of an international veterinary certificate attesting that the products are derived from animals
which remained in the RVF infection free country/free zone since birth or for the last 30 days.
Article 2.2.14.8.
When importing from RVF infected countries/zones without disease, Veterinary Administrations should
require:
for ruminants
the presentation of an international veterinary certificate attesting that the animals:
1. showed no evidence of RFV on the day of shipment;
2. were kept in a RVF infected country/zone free of disease since birth or for the last 6 months
providing that climatic changes predisposing to outbreaks of RVF have not occurred during this time;
OR
3. were vaccinated against RVF at least 21 days prior to shipment with modified live virus vaccine;
OR
4. were held in a mosquito-proof quarantine station for at least 30 days prior to shipment during which
the animals showed no clinical signs of RVF and were protected from mosquitoes between
quarantine and the place of shipment and at the place of shipment;
AND
5. did not transit through an infected zone with disease during transportation of the place of shipment.
Article 2.2.14.9.
When importing from RVF infected countries or zones without disease, Veterinary Administrations should
require:
for meat and meat products of domestic and wild ruminants
the presentation of an international veterinary certificate attesting that:
1. the products are derived from animals which:
a) remained in the RVF disease free country/zone since birth or for the last 30 days;
b) were slaughtered in an approved abattoir and were subjected to ante-mortem and post-mortem
inspections for RVF with favourable results;
2. the carcasses from which the products were derived were submitted to maturation at a temperature
above +2°C for a minimum period of 24 hours following slaughter.
Article 2.2.14.10.
When importing from RVF infected countries or zones with disease, Veterinary Administrations should
require:
for ruminants
the presentation of an international veterinary certificate attesting that the animals:
1. showed no evidence of RVF on the day of shipment;
2. were vaccinated against RVF at least 21 days prior to shipment with modified live virus vaccine;
OR
3. were held in a mosquito-proof quarantine station for at least 30 days prior to shipment during which
the animals showed no clinical signs of RVF and were protected from mosquito attack between
quarantine and the place of shipment and at the place of shipment.
Article 2.2.14.11.
When importing from RVF infected countries or zones with disease, Veterinary Administrations should
require:
for meat and meat products of domestic and wild ruminants
the presentation of an international veterinary certificate attesting that the carcasses:
1. are from animals which have been slaughtered in an approved abattoir and have been subjected to
ante-mortem and post-mortem inspections for RVF with favourable results; and
2. have been fully eviscerated and submitted to maturation at a temperature above +2°C for a
minimum period of 24 hours following slaughter.
Article 2.2.14.12.
When importing from RVF infected countries or zones with disease, Veterinary Administrations should
require:
for in vivo derived embryos of ruminants
the presentation of an international veterinary certificate attesting that the donor animals:
1. showed no evidence of RVF within the period from 28 days prior to 28 days following collection of
the embryos;
2. were vaccinated against RVF at least 21 days prior to collection with modified live virus vaccine;
OR
3. were serologically tested on the day of collection and at least 14 days following collection and
showed no significant rise in titre.
JAPANESE ENCEPHALITIS
Article 2.2.15.1.
For the purposes of this Terrestrial Code, the incubation period for Japanese encephalitis shall be 21 days.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.2.15.2.
When importing from countries or zones infected with Japanese encephalitis, Veterinary Administrations
should require:
for horses
EITHER
2. were kept for the 21 days prior to shipment, in an insect-proof quarantine station and were protected
from insect vector attack during their transportation from the quarantine station to the place of
shipment;
OR
3. were vaccinated against Japanese encephalitis not less than 7 days and no more than 12 months prior
to shipment.
TULAREMIA
Article 2.2.16.1.
For the purposes of this Terrestrial Code, the incubation period for tularemia (in hares, genus Lepus) shall be
15 days.
Standards for diagnostic tests are described in the Terrestrial Manual.
Article 2.2.16.2.
A country may be considered free from tularemia when it has been shown that tularemia has not been
present for at least the past 2 years and when bacteriological or serological surveys in previously infected
zones have given negative results.
Article 2.2.16.3.
Article 2.2.16.4.
Veterinary Administrations of tularemia free countries may prohibit importation or transit through their
territory, from countries considered infected with tularemia, of live hares.
Article 2.2.16.5.
When importing from countries considered infected with tularemia, Veterinary Administrations should
require:
for live hares
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of tularemia on the day of shipment;
2. were not kept in a tularemia infected zone;
3. have been treated against parasites (ticks); and
CATTLE DISEASES
CHAPTER 2.3.1.
BOVINE BRUCELLOSIS
Article 2.3.1.1.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.3.1.2.
To qualify as free from bovine brucellosis, a country or zone shall satisfy the following requirements:
2. the entire cattle population of a country or zone is under official veterinary control and it has been
ascertained that the rate of brucellosis infection does not exceed 0.2% of the cattle herds in the
country or zone under consideration;
3. the serological tests for bovine brucellosis are periodically conducted in each herd, with or without
the ring test;
4. no animal has been vaccinated against bovine brucellosis for at least the past 3 years;
6. animals introduced into a free country or zone shall only come from herds officially free from
bovine brucellosis or from herds free from bovine brucellosis. This condition may be waived for
animals which have not been vaccinated and which, prior to entry into the herd, were isolated and
were subjected to the serological tests for bovine brucellosis with negative results on two occasions,
with an interval of 30 days between each test. These tests are not considered valid in female animals
which have calved during the past 14 days.
In a country where all herds of cattle have qualified as officially free from bovine brucellosis and
where no reactor has been found for the past 5 years, the system for further control may be decided
by the country concerned.
Article 2.3.1.3.
To qualify as officially free from bovine brucellosis, a herd of cattle shall satisfy the following
requirements:
1. it is under official veterinary control;
2. it contains no animal which has been vaccinated against bovine brucellosis during at least the past
3 years;
3. it only contains animals which have not showed evidence of bovine brucellosis infection during the
past 6 months, all suspect cases (such as animals which have prematurely calved) having been
subjected to the necessary laboratory investigations;
4. all cattle over the age of one year (except castrated males) were subjected to serological tests with
negative results on two occasions, at an interval of 12 months between each test; this requirement is
maintained even if the entire herd is normally tested every year or testing is conducted in conformity
with other requirements established by the Veterinary Administration of the country concerned;
5. additions to the herd shall only come from herds officially free from bovine brucellosis. This
condition may be waived for animals which have not been vaccinated, come from a herd free from
bovine brucellosis, provided that negative results were shown following a buffered Brucella antigen
test and the complement fixation test during the 30 days prior to entry into the herd. Any recently
calved or calving animal should be retested after 14 days, as tests are not considered valid in female
animals which have calved during the past 14 days.
Article 2.3.1.4.
To qualify as free from bovine brucellosis, a herd of cattle shall satisfy the following requirements:
1. it is under official veterinary control;
2. it is subjected to either a vaccination or a non-vaccination regime;
3. if a live vaccine is used in female cattle, vaccination must be carried out between 3 and 6 months of
age, in which case these female cattle must be identified with a permanent mark;
4. all cattle over the age of one year are controlled as provided in paragraph 4) of the definition of a
herd of cattle officially free from bovine brucellosis; however, cattle under 30 months of age which
have been vaccinated using a live vaccine before reaching 6 months of age, may be subjected to a
buffered Brucella antigen test with a positive result, with the complement fixation test giving a
negative result;
5. all cattle introduced into the herd come from a herd officially free from bovine brucellosis or from a
herd free from bovine brucellosis, or from a country or zone free from bovine brucellosis. This
condition may be waived for animals which have been isolated and which, prior to entry into the
herd, were subjected to the serological tests for bovine brucellosis with negative results on
two occasions, with an interval of 30 days between each test. These tests are not considered valid in
female animals which have calved during the past 14 days.
Article 2.3.1.5.
Article 2.3.1.6.
Article 2.3.1.7.
c) were kept in a herd free from bovine brucellosis, showed no clinical sign of bovine brucellosis
on the day of collection and were subjected to the buffered Brucella antigen and complement
fixation tests with negative results during the 30 days prior to collection; or
3. the semen was collected, processed and stored in conformity with the provisions of Appendix 3.2.1.
Article 2.3.1.8.
the presentation of an international veterinary certificate attesting that the embryos were collected, processed
and stored in conformity with the provisions of Appendix 3.3.1. or Appendix 3.3.3., as relevant.
Article 2.3.1.9.
b) were kept in a herd officially free from bovine brucellosis and were subjected to tests as
prescribed in Appendix 3.1.1.;
2. the oocytes were fertilised with semen meeting the conditions referred to in Appendix 3.2.1.;
3. the embryos/oocytes were collected, processed and stored in conformity with the provisions of
Appendix 3.3.1., Appendix 3.3.2. or Appendix 3.3.3., as relevant.
Article 2.3.2.1.
Article 2.3.2.2.
Article 2.3.2.3.
Article 2.3.2.4.
c) were kept in an establishment or artificial insemination centre where no case of bovine genital
campylobacteriosis has been reported;
2. the culture of semen and preputial specimens for the presence of the causal agent of bovine genital
campylobacteriosis proved negative.
BOVINE TUBERCULOSIS
Article 2.3.3.1.
The recommendations in this Chapter are intended to manage the human and animal health risks
associated with Mycobacterium bovis (M. bovis) infection in cattle (Bos taurus, B. indicus and B. grunniens) and
buffalo (Bubalus bubalis).
When authorising import or transit of the following commodities, Veterinary Administrations should comply
with the requirements prescribed in this Chapter relevant to the status of bovine tuberculosis in the
exporting country, zone or compartment:
1. live animals;
2. semen, ova and in vivo derived embryos collected and handled in accordance with the
recommendations of the International Embryo Transfer Society;
3. meat and meat products;
4. milk and milk products.
Standards for diagnostic tests are described in the Terrestrial Manual.
Article 2.3.3.2.
To qualify as free from bovine tuberculosis, a country, zone or compartment should satisfy the following
requirements:
1. bovine tuberculosis is a notifiable disease in the country;
2. regular and periodic testing of all cattle and buffalo herds has shown that at least 99.8% of the herds
and 99.9% of the animals in the country, zone or compartment have been found free from bovine
tuberculosis for 3 consecutive years;
3. a surveillance programme should be in place to detect bovine tuberculosis in the country, zone or
compartment, through monitoring at slaughter based on the inspection described in Article 2.3.3.8.;
4. cattle and buffalo introduced into a country, zone or compartment free from bovine tuberculosis
should be accompanied by a certificate from an Official Veterinarian attesting that they come from a
country, zone or compartment or herd free from bovine tuberculosis.
Article 2.3.3.3.
To qualify as free from bovine tuberculosis, a herd of cattle or buffalo should satisfy the following
requirements:
1. the herd is in a country, zone or compartment free from bovine tuberculosis and is certified free by the
Veterinary Administration; or
Article 2.3.3.4.
Article 2.3.3.5.
Article 2.3.3.6.
b) were kept in an artificial insemination centre free from bovine tuberculosis in a country, zone or
compartment free from bovine tuberculosis and which only accepts animals from free herds in a
free country, zone or compartment; or
c) showed negative results to tuberculin tests carried out annually and were kept in a herd free
from bovine tuberculosis;
2. the semen was collected, processed and stored in conformity with the provisions of Appendix 3.2.1.
Article 2.3.3.7.
Article 2.3.3.8.
Article 2.3.3.9.
Article 2.3.4.1.
Article 2.3.4.2.
1. Qualification
To qualify as free from enzootic bovine leukosis (EBL), a country or zone must satisfy the following
requirements for at least 3 years:
a) all tumours, suspected to be lymphosarcoma, are reported to the Veterinary Authority, and are
examined at a laboratory by appropriate diagnostic techniques;
b) all animals with tumours in which EBL has been confirmed or cannot be ruled out are traced
back to the herds in which they have been kept since birth; all cattle over 24 months of age in
these herds are subjected to an individual diagnostic test for EBL;
c) at least 99.8% of the herds are qualified as EBL free.
2. Maintenance of free status
For a country or zone to maintain its EBL free status:
a) a serological survey must be carried out annually on a random sample of the cattle population of
the country or zone sufficient to provide a 99% level of confidence of detecting EBL if it is
present at a prevalence rate exceeding 0.2% of the herds;
b) all imported bovines (except for slaughter) comply with the provisions of Article 2.3.4.4.;
c) all imported bovine semen and embryos/ova fulfil the requirements referred to in
Article 2.3.4.5. and in Article 2.3.4.6., respectively.
Article 2.3.4.3.
1. Qualification
To qualify as free from EBL, a herd must satisfy the following requirements:
a) there has been no evidence of EBL either clinical, post-mortem, or as a result of a diagnostic
test for EBL within the previous 2 years;
b) all animals over 24 months of age have been subjected to a diagnostic test for EBL on
two occasions with negative results, at an interval of not less than 4 months during the
preceding 12 months;
c) animals introduced into the herd after the first test have fulfilled the conditions of
Article 2.3.4.4.;
d) all bovine semen and embryos/ova introduced into the herd after the first test have fulfilled the
conditions referred to in Article 2.3.4.5. and in Article 2.3.4.6., respectively.
2. Maintenance of free status
For a herd to maintain its EBL free status, the animals in the herd over 24 months of age on the day
of sampling must be subjected to a diagnostic test for EBL with negative results at intervals of no
more than 36 months and the conditions referred to in points 1)a), 1)c) and 1)d) above continue to
be fulfilled.
3. Suspension and restoration of free status
If in an EBL free herd any animals react positively to a diagnostic test for EBL or a virological test
(under study) for bovine leukosis virus, the status of the herd shall be suspended until the following
measures have been taken:
a) the animals which have reacted positively, and their progeny since the last negative test, must be
removed from the herd immediately; however, any animal within the progeny which has been
subjected to a PCR test with negative results (under study) may be retained in the herd;
b) the remaining animals must have been subjected to a diagnostic test for EBL carried out as
described in point 1)b) above with negative results at least 4 months after removal of the
positive animals and their progeny.
Article 2.3.4.4.
Article 2.3.4.5.
Article 2.3.4.6.
Article 2.3.5.1.
For the purposes of this Terrestrial Code, the incubation period for infectious bovine
rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV) shall be 21 days.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.3.5.2.
1. Qualification
To qualify as free from IBR/IPV, a country or zone must satisfy the following requirements:
a) the disease or suspicion of the disease is notifiable;
b) no animal has been vaccinated against IBR/IPV for at least 3 years;
c) at least 99.8% of the herds are qualified as free from IBR/IPV.
2. Maintenance of free status
For a country or zone to maintain its status free from IBR/IPV:
a) a serological survey should be carried out annually on a random sample of the cattle population
of the country or zone sufficient to provide a 99% level of confidence of detecting IBR/IPV if
it is present at a prevalence rate exceeding 0.2% of the herds;
b) all imported bovines comply with the provisions of Article 2.3.5.4.;
c) all imported bovine semen and embryos/ova fulfil the requirements referred to in
Articles 2.3.5.6. or 2.3.5.7., and in Article 2.3.5.8., respectively.
Article 2.3.5.3.
1. Qualification
To qualify as free from IBR/IPV, a herd of cattle must satisfy the following requirements:
a) all the animals in the herd have been subjected to a diagnostic test for IBR/IPV on a blood
sample on two occasions with negative results, at an interval of not less than 2 months and not
more than 12 months; or
b) if the herd contains only dairy cattle of which at least a quarter are lactating cows, each of the
latter has been subjected to a diagnostic test on individual milk samples carried out on
three occasions at intervals of 2 months with negative results;
c) animals introduced into the herd after the first tests referred to in point a) or point b) as
relevant have been:
i) kept in an IBR/IPV free herd; or
ii) placed in isolation for a period of 30 days, and during this period have been subjected to a
diagnostic test for IBR/IPV on a blood sample on two occasions with negative results, at
an interval of not less than 21 days;
d) all bovine semen and embryos/ova introduced into the herd after the first tests referred to in
point a) or point b) as relevant have fulfilled the conditions provided in Articles 2.3.5.6. or
2.3.5.7. and in Article 2.3.5.8., respectively.
2. Maintenance of free status
For a herd to maintain its status free from IBR/IPV, it must be subjected to the following tests with
negative results:
EITHER
a) diagnostic tests for IBR/IPV on blood samples for all the animals repeated at maximum
intervals of 12 months; in herds composed entirely of fattening animals, blood sampling may be
limited to animals sent for slaughter;
OR
b) diagnostic tests on individual milk samples from all lactating cows repeated at intervals of
6 months; Veterinary Administrations applying an IBR/IPV eradication programme may extend
these intervals (under study) if more than 98% of herds have been free from the disease for at
least 3 years; and
c) diagnostic tests on blood samples for IBR/IPV of all breeding bulls repeated at maximum
intervals of 12 months;
AND
d) diagnostic tests on blood samples for IBR/IPV of all cattle having aborted after more than
3 months of gestation.
Animals introduced into the herd must satisfy the conditions provided in point 1)c) above, and semen and
embryos/ova used in the herd must satisfy the conditions provided in Articles 2.3.5.6. or 2.3.5.7. and in
Article 2.3.5.8., respectively.
Article 2.3.5.4.
Article 2.3.5.5.
for cattle intended for herds not qualified as free from IBR/IPV
2. were vaccinated with an inactivated virus vaccine not less than one month and not more than
6 months prior to shipment.
Article 2.3.5.6.
1. the donor animals were kept in an IBR/IPV free herd at the time of collection of the semen;
2. the semen was collected, processed and stored in conformity with the provisions of Appendix 3.2.1.
Article 2.3.5.7.
1. the donor animals were kept in an IBR/IPV free herd at the time of collection of the semen; or
2. the donor animals were held in isolation during the period of collection and for the 30 days following
collection and were subjected to a diagnostic test for IBR/IPV on a blood sample taken at least
21 days after collection of the semen, with negative results; or
3. if the serological status of the bull is unknown or if the bull is serologically positive, an aliquot of
each semen collection was subjected to a virus isolation test, with negative results; and
4. the semen was collected, processed and stored in conformity with the provisions of Appendix 3.2.1.
Article 2.3.5.8.
for embryos/ova
the presentation of an international veterinary certificate attesting that the embryos/ova were collected,
processed and stored in conformity with the provisions of Appendix 3.3.1., Appendix 3.3.2. or
Appendix 3.3.3., as relevant.
TRICHOMONOSIS
Article 2.3.6.1.
Article 2.3.6.2.
Article 2.3.6.3.
Article 2.3.6.4.
4. the donor animals were subjected to a direct microscopic and cultural examination of preputial
specimens with negative results;
5. the semen was collected, processed and stored in conformity with the provisions of Appendix 3.2.1.
BOVINE ANAPLASMOSIS
Article 2.3.7.1.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.3.7.2.
When importing from countries considered infected with bovine anaplasmosis, Veterinary Administrations
of free countries should require:
for cattle
2. were, since birth, kept in a zone known to be free of bovine anaplasmosis for the previous 2 years;
OR
4. were subjected to a diagnostic test for bovine anaplasmosis with negative results during 30 days prior
to shipment; and
5. were treated with an effective drug such as oxytetracycline for 5 consecutive days at a dose of
22 mg/kg (under study);
AND
6. were treated with an acaricide and, if necessary, a repellant against biting insects prior to shipment
and were completely free of ticks.
BOVINE BABESIOSIS
Article 2.3.8.1.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.3.8.2.
When importing from countries considered infected with bovine babesiosis, Veterinary Administrations of
free countries should require:
for cattle
2. were, since birth, resident in a zone known to be free of bovine babesiosis for the previous 2 years;
OR
4. were subjected to a diagnostic test for bovine babesiosis with negative results during 30 days prior to
shipment; and
5. were treated with an effective drug such as imidocarb as a single dose injection at 2 mg/kg or
amicarbalide at 10 mg/kg (under study);
AND
6. were treated with an acaricide prior to shipment and were completely free of ticks.
BOVINE CYSTICERCOSIS
Article 2.3.9.1.
Article 2.3.9.2.
DERMATOPHILOSIS
Article 2.3.10.1.
Article 2.3.10.2.
When importing from countries considered infected with dermatophilosis, Veterinary Administrations
should require:
for ruminants and equines
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of dermatophilosis on the day of shipment;
2. were treated with acaricides prior to shipment and were completely free of ticks.
THEILERIOSIS
Article 2.3.11.1.
For the purposes of the Terrestrial Code, theileriosis is defined as a highly fatal disease in cattle and
buffaloes caused by Theileria parva and T. annulata.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.3.11.2.
When importing from countries considered infected with theileriosis, Veterinary Administrations of free
countries should require:
for cattle
2. were, since birth, kept in a zone known to be free of theileriosis for the previous 2 years;
OR
4. were subjected to a diagnostic test for theileriosis with negative results during the 30 days prior to
shipment (under study); and
AND
6. were treated with an acaricide prior to shipment and were completely free of ticks.
HAEMORRHAGIC SEPTICAEMIA
(Pasteurella multocida serotypes 6:b and 6:e)
Article 2.3.12.1.
For the purposes of this Terrestrial Code, haemorrhagic septicaemia (HS) is defined as a highly fatal disease
in cattle and buffaloes caused by specific serotypes of Pasteurella multocida designated as 6:B and 6:E. The
incubation period for the disease shall be 90 days (active and latent carriers occur).
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.3.12.2.
Article 2.3.12.3.
A zone may be considered free of the disease if it can be established that HS has not been present for at
least the past 3 years and if the following conditions are met:
1. the disease is notifiable in the whole country;
2. the zone shall be delineated by natural or artificial barriers;
3. the introduction of animals into the zone shall be carried out in conformity with the provisions of
Articles 2.3.12.6. or 2.3.12.7.
Article 2.3.12.4.
A zone shall be considered as infected with HS until at least 6 months have elapsed after the confirmation
of the last case and the completion of a stamping-out policy and disinfection procedures.
Article 2.3.12.5.
Veterinary Administrations of HS free countries may prohibit importation or transit through their territory,
from countries considered infected with HS, of cattle and buffaloes.
Article 2.3.12.6.
When importing from HS free countries or zones, Veterinary Administrations should require:
for cattle and buffaloes
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of HS on the day of shipment; and
2. were kept in a country or zone free from HS since birth or for at least 6 months.
Article 2.3.12.7.
When importing from countries considered infected with HS, Veterinary Administrations should require:
for cattle and buffaloes
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of HS on the day of shipment; and
2. were kept in a quarantine station for 3 months prior to shipment; and
3. were examined for the presence of the causative organism in the naso-pharynx, in conformity with
the procedures described in the Terrestrial Manual, on four occasions, at weekly intervals during the
last month in quarantine with negative results; and
4. were vaccinated not less than 30 days prior to shipment (under study); or
5. showed a positive reaction to the passive mouse protection test (under study) conducted during
pre-shipment quarantine.
Article 2.3.13.1.
The recommendations in this Chapter are intended to manage the human and animal health risks
associated with the presence of the bovine spongiform encephalopathy (BSE) agent in cattle (Bos taurus
and B. indicus) only.
1. When authorising import or transit of the following commodities and any products made from these
commodities and containing no other tissues from cattle, Veterinary Administrations should not require
any BSE related conditions, regardless of the BSE risk status of the cattle population of the exporting
country, zone or compartment:
a) milk and milk products;
b) semen and in vivo derived cattle embryos collected and handled in accordance with the
recommendations of the International Embryo Transfer Society;
c) hides and skins;
d) gelatin and collagen prepared exclusively from hides and skins;
e) protein-free tallow (maximum level of insoluble impurities of 0.15% in weight) and derivatives
made from this tallow;
f) dicalcium phosphate (with no trace of protein or fat);
g) deboned skeletal muscle meat (excluding mechanically separated meat) from cattle 30 months of
age or less, which were not subjected to a stunning process, prior to slaughter, with a device
injecting compressed air or gas into the cranial cavity, or to a pithing process, and which were
subject to ante-mortem and post-mortem inspections and were not suspect or confirmed BSE
cases; and which has been prepared in a manner to avoid contamination with tissues listed in
Article 2.3.13.13.;
h) blood and blood by-products, from cattle which were not subjected to a stunning process, prior
to slaughter, with a device injecting compressed air or gas into the cranial cavity, or to a pithing
process.
2. When authorising import or transit of other commodities listed in this Chapter, Veterinary
Administrations should require the conditions prescribed in this Chapter relevant to the BSE risk
status of the cattle population of the exporting country, zone or compartment.
Standards for diagnostic tests are described in the Terrestrial Manual.
Article 2.3.13.2.
The BSE risk status of the cattle population of a country, zone or compartment should be determined on
the basis of the following criteria:
1. the outcome of a risk assessment (which is reviewed annually), based on Section 1.3. of this Terrestrial
Code, identifying all potential factors for BSE occurrence and their historic perspective:
a) Release assessment
Release assessment consists of assessing the likelihood that a transmissible spongiform
encephalopathy (TSE) agent has been introduced into the cattle population from a pre-existing
TSE in the indigenous ruminant population or via commodities potentially contaminated with a
TSE agent, through a consideration of the following:
i) the presence or absence of animal TSE agents in the country or zone or compartment and, if
present, their prevalence based on the outcomes of surveillance;
vi) imported products of ruminant origin for human consumption, which may have contained
tissues listed in Article 2.3.13.13. and may have been fed to cattle;
Surveillance and other epidemiological investigations (especially surveillance for BSE conducted
on the cattle population) relevant to the above should be taken into account in carrying out the
assessment.
b) Exposure assessment
If the release assessment identifies a risk factor, an exposure assessment should be conducted,
consisting of assessing the likelihood of exposure of the BSE agent to cattle, through a
consideration of the following:
ii) the use of ruminant carcasses (including from fallen stock), by-products and
slaughterhouse waste, the parameters of the rendering processes and the methods of
animal feed manufacture;
iii) the feeding or not of ruminants with meat-and-bone meal and greaves derived from
ruminants, including measures to prevent cross-contamination of animal feed;
iv) the level of surveillance for BSE conducted on the cattle population to that time and the
results of that surveillance;
2. on-going awareness programme for veterinarians, farmers, and workers involved in transportation,
marketing and slaughter of cattle to encourage reporting of all cases showing clinical signs consistent
with BSE in target sub-populations as defined in Appendix 3.8.4.;
3. the compulsory notification and investigation of all cattle showing clinical signs consistent with BSE;
4. the examination in an approved laboratory of brain or other tissues collected within the framework of
the aforementioned surveillance and monitoring system.
When the risk assessment (which takes into account the surveillance referred to in the release and exposure
assessments above) demonstrates non-negligible risk, the country should conduct Type A surveillance in
accordance with Appendix 3.8.4.
When the risk assessment (which takes into account the surveillance referred to in the release and exposure
assessments above) demonstrates negligible risk, the country should conduct Type B surveillance in
accordance with Appendix 3.8.4.
Article 2.3.13.3.
Commodities from the cattle population of a country, zone or compartment pose a negligible risk of
transmitting the BSE agent, should the following conditions be met:
1. a risk assessment, as described in point 1) of Article 2.3.13.2., has been conducted in order to identify
the historical and existing risk factors, and the country has demonstrated that appropriate generic
measures have been taken for the relevant period of time defined below to manage all risks
identified;
2. the country has demonstrated that Type B surveillance in accordance with Appendix 3.8.4. is in
place;
3. EITHER:
a) there has been no case of BSE, or any case of BSE has been demonstrated to have been
imported and has been completely destroyed, and
i) the criteria in points 2) to 4) of Article 2.3.13.2. have been complied with for at least
7 years; and
ii) it has been demonstrated, through an appropriate level of control and audit, that for at
least 8 years meat-and-bone meal or greaves derived from ruminants has not been fed to
ruminants;
OR
b) the last indigenous case of BSE was reported more than 7 years ago; and
i) the criteria in points 2) to 4) of Article 2.3.13.2. have been complied with for at least
7 years; and
ii) it has been demonstrated, thorough an appropriate level of control and audit, that for at
least 8 years meat-and-bone meal and greaves derived from ruminants has not been fed to
ruminants; and
iii) all BSE cases, as well as:
- all the progeny of female cases, born within 2 years prior to or after clinical onset of
the disease, and
- all cattle which, during their first year of life, were reared with the BSE cases during
their first year of life, and which investigation showed consumed the same potentially
contaminated feed during that period, or
- if the results of the investigation are inconclusive, all cattle born in the same herd as,
and within 12 months of the birth of, the BSE cases,
if alive in the country, zone or compartment, are permanently identified, and their movements
controlled, and, when slaughtered or at death, are completely destroyed.
Article 2.3.13.4.
Commodities from the cattle population of a country, zone or compartment pose a controlled risk of
transmitting the BSE agent, should the following conditions be met:
1. a risk assessment, as described in point 1) of Article 2.3.13.2., has been conducted in order to identify
the historical and existing risk factors, and the country has not demonstrated that appropriate generic
measures have been taken for the relevant period of time defined below to manage all risks
identified;
2. the country has demonstrated that Type A surveillance in accordance with Appendix 3.8.4. is in
place;
3. EITHER:
a) there has been no case of BSE or any case of BSE has been demonstrated to have been imported
and has been completely destroyed, the criteria in points 2) to 4) of Article 2.3.13.2. are
complied with, and it can be demonstrated, through an appropriate level of control and audit,
that meat-and-bone meal and greaves derived from ruminants has not been fed to ruminants, but at
least one of the following two conditions applies:
i) the criteria in points 2) to 4) of Article 2.3.13.2. have not been complied with for 7 years;
ii) it cannot be demonstrated that controls over the feeding of meat-and-bone meal or greaves
derived from ruminants to ruminants have been in place for 8 years;
OR
b) there has been an indigenous case of BSE reported, the criteria in points 2) to 4) of
Article 2.3.13.2. are complied with, and it can be demonstrated, through an appropriate level of
control and audit that meat-and-bone meal and greaves derived from ruminants have not been fed
to ruminants, but at least one of the following two conditions applies:
i) the criteria in points 2) to 4) of Article 2.3.13.2. have not been complied with for 7 years;
ii) it cannot be demonstrated that controls over the feeding of meat-and-bone meal and greaves
derived from ruminants to ruminants have been in place for 8 years;
AND
iii) all BSE cases, as well as:
- all the progeny of female cases, born within 2 years prior to or after clinical onset of
the disease, and
- all cattle which, during their first year of life, were reared with the BSE cases during
their first year of life, and which investigation showed consumed the same potentially
contaminated feed during that period, or
- if the results of the investigation are inconclusive, all cattle born in the same herd as,
and within 12 months of the birth of, the BSE cases,
if alive in the country, zone or compartment, are permanently identified, and their movements
controlled, and, when slaughtered or at death, are completely destroyed.
Article 2.3.13.5.
The cattle population of a country, zone or compartment poses an undetermined BSE risk if it cannot be
demonstrated that it meets the requirements of another category.
Article 2.3.13.6.
When importing from a country, zone or compartment posing a negligible BSE risk, Veterinary
Administrations should require:
for all commodities from cattle not listed in point 1) of Article 2.3.13.1.
the presentation of an international veterinary certificate attesting that the country, zone or compartment
complies with the conditions in Article 2.3.13.3.
Article 2.3.13.7.
When importing from a country, zone or compartment posing a controlled BSE risk, Veterinary
Administrations should require:
for cattle
the presentation of an international veterinary certificate attesting that:
1. the country, zone or compartment complies with the conditions in Article 2.3.13.4.;
2. cattle selected for export are identified by a permanent identification system enabling them to be
traced back to the dam and herd of origin, and are not exposed cattle as described in point 3) b) iii)
of Article 2.3.13.4.;
3. in the case of a country, zone or compartment with an indigenous case, cattle selected for export were
born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and
greaves derived from ruminants had been effectively enforced.
Article 2.3.13.8.
When importing from a country, zone or compartment with an undetermined BSE risk, Veterinary
Administrations should require:
for cattle
the presentation of an international veterinary certificate attesting that:
1. the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants has been
banned and the ban has been effectively enforced;
2. all BSE cases, as well as:
a) all the progeny of female cases, born within 2 years prior to or after clinical onset of the disease,
and
b) all cattle which, during their first year of life, were reared with the BSE cases during their first
year of life, and, which investigation showed consumed the same potentially contaminated feed
during that period, or
c) if the results of the investigation are inconclusive, all cattle born in the same herd as, and within
12 months of the birth of, the BSE cases,
if alive in the country, zone or compartment, are permanently identified, and their movements
controlled, and, when slaughtered or at death, are completely destroyed;
3. cattle selected for export:
a) are identified by a permanent identification system enabling them to be traced back to the dam
and herd of origin and are not the progeny of BSE suspect or confirmed females;
b) were born at least 2 years after the date from which the ban on the feeding of ruminants with
meat-and-bone meal and greaves derived from ruminants was effectively enforced.
Article 2.3.13.9.
When importing from a country, zone or compartment posing a negligible BSE risk, Veterinary
Administrations should require:
for fresh meat and meat products from cattle (other than those listed in point 1) of Article 2.3.13.1.)
the presentation of an international veterinary certificate attesting that:
1. the country, zone or compartment complies with the conditions in Article 2.3.13.3.;
2. ante-mortem and post-mortem inspections were carried out on all cattle from which the fresh meat or
meat products originate.
Article 2.3.13.10.
When importing from a country, zone or compartment posing a controlled BSE risk, Veterinary
Administrations should require:
for fresh meat and meat products from cattle (other than those listed in point 1) of Article 2.3.13.1.)
the presentation of an international veterinary certificate attesting that:
1. the country, zone or compartment complies with the conditions in Article 2.3.13.4.;
2. ante-mortem and post-mortem inspections were carried out on all cattle from which the fresh meat
and meat products originate;
3. cattle from which the fresh meat and meat products destined for export originate were not subjected to
a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial
cavity, or to a pithing process;
4. the fresh meat and meat products do not contain:
a) the tissues listed in Article 2.3.13.13.,
b) mechanically separated meat from the skull and vertebral column from cattle over 30 months of
age,
all of which have been completely removed in a manner to avoid contamination of the fresh meat and
meat products.
Article 2.3.13.11.
When importing from a country, zone or compartment with an undetermined BSE risk, Veterinary
Administrations should require:
for fresh meat and meat products from cattle (other than those listed in point 1) of Article 2.3.13.1.)
the presentation of an international veterinary certificate attesting that:
1. the cattle from which the fresh meat and meat products originate:
a) are not suspect or confirmed BSE cases;
b) have not been fed meat-and-bone meal or greaves;
c) were subjected to ante-mortem and post-mortem inspections;
d) were not subjected to a stunning process, prior to slaughter, with a device injecting compressed
air or gas into the cranial cavity, or to a pithing process;
2. the fresh meat and meat products do not contain:
a) the tissues listed in Article 2.3.13.13.,
Article 2.3.13.12.
Ruminant-derived meat-and-bone meal or greaves, or any commodities containing such products, which
originate from a country, zone or compartment defined in Articles 2.3.13.4. and 2.3.13.5. should not be
traded between countries.
Article 2.3.13.13.
1. From cattle of any age originating from a country, zone or compartment defined in Articles 2.3.13.4.
and 2.3.13.5., the following commodities, and any commodity contaminated by them, should not be
traded for the preparation of food, feed, fertilisers, cosmetics, pharmaceuticals including biologicals,
or medical devices: tonsils and distal ileum, and protein products derived thereof. Food, feed,
fertilisers, cosmetics, pharmaceuticals or medical devices prepared using these commodities should
also not be traded.
2. From cattle that were at the time of slaughter over 30 months of age originating from a country, zone
or compartment defined in Article 2.3.13.4., the following commodities, and any commodity
contaminated by them, should not be traded for the preparation of food, feed, fertilisers, cosmetics,
pharmaceuticals including biologicals, or medical devices: brains, eyes, spinal cord, skull, vertebral
column and derived protein products. Food, feed, fertilisers, cosmetics, pharmaceuticals or medical
devices prepared using these commodities should also not be traded.
3. From cattle that were at the time of slaughter over 12 months of age originating from a country, zone
or compartment defined in Article 2.3.13.5., the following commodities, and any commodity
contaminated by them, should not be traded for the preparation of food, feed, fertilisers, cosmetics,
pharmaceuticals including biologicals, or medical devices: brains, eyes, spinal cord, skull, vertebral
column and derived protein products. Food, feed, fertilisers, cosmetics, pharmaceuticals or medical
devices prepared using these commodities should also not be traded.
Article 2.3.13.14.
iv) filtration,
Article 2.3.13.15.
for tallow and dicalcium phosphate (other than protein-free tallow as defined in Article 2.3.13.1.) intended
for food, feed, fertilisers, cosmetics, pharmaceuticals including biologicals, or medical devices
2. a country, zone or compartment posing a controlled BSE risk, and it originates from cattle which have
been subjected to ante-mortem and post-mortem inspection and has not been prepared using the
tissues listed in point 2) of Article 2.3.13.13.
Article 2.3.13.16.
for tallow derivatives (other than those made from protein-free tallow as defined in Article 2.3.13.1.)
intended for food, feed, fertilisers, cosmetics, pharmaceuticals including biologicals, or medical devices
1. they originate from a country, zone or compartment posing a negligible BSE risk; or
2. they have been produced by hydrolysis, saponification or transesterification using high temperature
and pressure.
Article 2.3.14.1.
For the purposes of this Terrestrial Code, the incubation period for lumpy skin disease (LSD) shall be
28 days.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.3.14.2.
Article 2.3.14.3.
Veterinary Administrations of LSD free countries may prohibit importation or transit through their
territory, from countries considered infected with LSD, of the following commodities:
1. domestic and wild animals of the bovine species;
2. semen of animals of the bovine species.
Article 2.3.14.4.
When importing from LSD free countries, Veterinary Administrations should require:
for domestic bovines
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of LSD on the day of shipment;
2. come from an LSD free country.
Article 2.3.14.5.
When importing from LSD free countries, Veterinary Administrations should require:
for wild bovines
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of LSD on the day of shipment;
2. come from an LSD free country;
if the country of origin has a common border with a country considered infected with LSD:
3. were kept in a quarantine station for the 28 days prior to shipment.
Article 2.3.14.6.
When importing from countries considered infected with LSD, Veterinary Administrations should require:
for domestic bovines
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of LSD on the day of shipment;
2. were not vaccinated against LSD during the 30 days prior to shipment; or
3. were vaccinated against LSD not more than 3 months prior to shipment;
4. were kept since birth, or for the past 28 days, in an establishment where no case of LSD was officially
reported during that period; or
5. were kept in a quarantine station for the 28 days prior to shipment.
Article 2.3.14.7.
When importing from countries considered infected with LSD, Veterinary Administrations should require:
for wild bovines
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of LSD on the day of shipment;
2. were kept in a quarantine station for the 28 days prior to shipment.
Article 2.3.14.8.
When importing from LSD free countries, Veterinary Administrations should require:
for semen of bovines
the presentation of an international veterinary certificate attesting that the donor animals:
1. showed no clinical sign of LSD on the day of collection of the semen and for the following 28 days;
2. were kept in an LSD free country.
Article 2.3.14.9.
When importing from countries considered infected with LSD, Veterinary Administrations should require:
for semen of bovines
the presentation of an international veterinary certificate attesting that the donor animals:
1. showed no clinical sign of LSD on the day of collection of the semen and for the following 28 days;
2. were kept in the exporting country for the 28 days prior to collection, in an establishment or artificial
insemination centre where no case of LSD was officially reported during that period, and that the
establishment or artificial insemination centre was not situated in an LSD infected zone.
Article 2.3.14.10.
When importing from LSD free countries, Veterinary Administrations should require:
for products of animal origin (from bovines) intended for agricultural or industrial use
the presentation of an international veterinary certificate attesting that these products come from animals
which have been kept in an LSD free country since birth or for at least the past 28 days.
Article 2.3.14.11.
When importing from countries considered infected with LSD, Veterinary Administrations should require:
for products of animal origin (from bovines) intended for agricultural or industrial use
the presentation of an international veterinary certificate attesting that these products have been processed to
ensure the destruction of the LSD virus.
Article 2.3.14.12.
When importing from countries considered infected with LSD, Veterinary Administrations should require:
for raw hides of bovines
the presentation of an international veterinary certificate attesting that these products were stored for at least
40 days before shipment.
Article 2.3.15.1.
For the purposes of this Terrestrial Code, the incubation period for contagious bovine pleuropneumonia
(CBPP) shall be 6 months.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.3.15.2.
To be declared free from either disease or infection by the OIE, a country should meet the requirements
contained in Appendix 3.8.3.
Article 2.3.15.3.
To be declared free from either disease or infection by the OIE, a zone defined according to the
provisions of Chapter 1.3.5. should meet the requirements contained in Appendix 3.8.3.
Article 2.3.15.4.
When the requirements for acceptance as a CBPP free country or zone are not fulfilled, a country or zone
shall be considered as infected.
Article 2.3.15.5.
Veterinary Administrations of CBPP free countries may prohibit importation or transit through their
territory, from countries considered infected with CBPP, of domestic and wild bovidae.
Article 2.3.15.6.
When importing from CBPP free countries, Veterinary Administrations should require:
for domestic bovidae
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of CBPP on the day of shipment;
2. were kept in a CBPP free country since birth or for at least the past 6 months.
Article 2.3.15.7.
When importing from CBPP free countries, Veterinary Administrations should require:
for wild bovidae
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of CBPP on the day of shipment;
2. come from a CBPP free country;
if the country of origin has a common border with a country considered infected with CBPP:
3. were kept in a quarantine station for the 6 months prior to shipment.
Article 2.3.15.8.
When importing from CBPP infected countries, Veterinary Administrations should require:
for bovidae for breeding
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of CBPP on the day of shipment;
2. were subjected to the complement fixation test for CBPP with negative results, on two occasions,
with an interval of not less than 21 days and not more than 30 days between each test, the second
test being performed within 14 days prior to shipment;
3. were isolated from other domestic bovidae from the day of the first complement fixation test until
shipment;
4. were kept since birth, or for the past 6 months, in an establishment where no case of CBPP was
officially reported during that period, and that the establishment was not situated in a CBPP infected
zone;
5. have not been vaccinated against CBPP; or
6. were vaccinated using a vaccine complying with the standards described in the Terrestrial Manual not
more than 4 months prior to shipment. In this case, the condition laid down in point 2) above is not
required.
Article 2.3.15.9.
When importing from CBPP infected countries, Veterinary Administrations should require:
for bovidae for slaughter
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of CBPP on the day of shipment;
2. were kept since birth, or for the past 6 months, in an establishment where no case of CBPP was
officially reported during that period, and that the establishment was not situated in a CBPP infected
zone.
Article 2.3.15.10.
When importing from CBPP infected countries, Veterinary Administrations should require:
Article 2.3.15.11.
When importing from CBPP infected countries, Veterinary Administrations should require:
for fresh meat of bovidae
the presentation of an international veterinary certificate attesting that the entire consignment of meat comes
from animals:
1. which showed no lesion of CBPP;
2. which have been slaughtered in an approved abattoir and have been subjected to ante-mortem and
post-mortem inspections for CBPP with favourable results.
Article 2.3.15.12.
When importing from CBPP free countries, Veterinary Administrations should require:
for in vivo derived or in vitro produced embryos/oocytes of bovidae
the presentation of an international veterinary certificate attesting that:
1. the donor animals:
a) showed no clinical sign of CBPP on the day of collection of the embryos/oocytes;
b) were kept in a CBPP free country since birth or for at least the past 6 months;
2. the oocytes were fertilised with semen meeting the conditions referred to in points a) and b) above
and in Appendix 3.2.1.;
3. the embryos/oocytes were collected, processed and stored in conformity with the provisions of
Appendix 3.3.1., Appendix 3.3.2. or Appendix 3.3.3., as relevant.
Article 2.3.15.13.
When importing from CBPP infected countries, Veterinary Administrations should require:
for in vivo derived or in vitro produced embryos/oocytes of bovidae
the presentation of an international veterinary certificate attesting that:
1. the donor animals:
a) showed no clinical sign of CBPP on the day of collection of the embryos/oocytes;
b) were subjected to the complement fixation test for CBPP with negative results, on
two occasions, with an interval of not less than 21 days and not more than 30 days between
each test, the second test being performed within 14 days prior to collection;
c) were isolated from other domestic bovidae from the day of the first complement fixation test
until collection;
d) were kept since birth, or for the past 6 months, in an establishment where no case of CBPP was
reported during that period, and that the establishment was not situated in a CBPP infected zone;
e) have not been vaccinated against CBPP; or
f) were vaccinated using a vaccine complying with the standards described in the Terrestrial Manual
not more than 4 months prior to collection; in this case, the condition laid down in point b)
above is not required;
2. the oocytes were fertilised with semen meeting the conditions referred to in points a) to f) above and
in Appendix 3.2.1.;
3. the embryos/oocytes were collected, processed and stored in conformity with the provisions of
Appendix 3.3.1., Appendix 3.3.2. or Appendix 3.3.3., as relevant.
CHAPTER 2.4.1.
OVINE EPIDIDYMITIS
(Brucella ovis)
Article 2.4.1.1.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.4.1.2.
To qualify as free from ovine epididymitis, a sheep flock shall satisfy the following requirements:
1. it is under official veterinary control;
2. all sheep in the flock showed no clinical evidence of ovine epididymitis during the past year;
3. all sheep in the flock are permanently identified.
If some or all the males in the flock are vaccinated, the flock should still be regarded as free.
Article 2.4.1.3.
Article 2.4.1.4.
Article 2.4.2.1.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.4.2.2.
1. Qualification
To qualify as officially free from caprine and ovine brucellosis, a country or zone must satisfy the
following requirements:
a) the occurrence or suspected occurrence of caprine and ovine brucellosis has been notifiable for
at least 5 years; and
b) all flocks of sheep and goats in the country or zone are under official veterinary control; and either
c) 99.8% of these flocks are qualified as officially free from caprine and ovine brucellosis; or
d) no case of brucellosis in sheep or goats has been reported for at least 5 years, and no sheep or
goat has been vaccinated against the disease for at least 3 years.
2. Maintenance of officially free status
For a country or zone to maintain its status as officially free from caprine and ovine brucellosis, a
serological survey should be carried out every year in the establishments or abattoirs on a
representative sample of the caprine and ovine flocks of the country or zone sufficient to provide at
least a 99% level of confidence of detecting caprine and ovine brucellosis if it is present at a
prevalence rate exceeding 0.2% of the flocks.
However, for a country or zone qualified as officially free under paragraph 1)d) above, maintenance
testing is not required.
Article 2.4.2.3.
Sheep or goat flock officially free from caprine and ovine brucellosis
1. Qualification
To qualify as officially free from caprine and ovine brucellosis, a sheep or goat flock must satisfy the
following requirements:
a) it is under official veterinary control;
b) no clinical, bacteriological or immunological evidence of caprine and ovine brucellosis has been
found for at least one year;
c) it contains only sheep or goats not vaccinated against brucellosis or permanently identified
animals which were vaccinated more than 2 years ago;
d) all sheep and goats over 6 months of age on the day of sampling have been subjected to a
diagnostic test for brucellosis with negative results on two occasions, at an interval of not more
than 12 months and not less than 6 months; however, for flocks situated in a country or zone
qualified as officially free under point 1)d) of Article 2.4.2.2., testing is not required;
e) when qualified, it contains only sheep and goats born therein or introduced in conformity with
the provisions of Article 2.4.2.5.
2. Maintenance of officially free status
For a flock to maintain its status as officially free from caprine and ovine brucellosis, a sample of the
animals in the flock must be subjected each year to a diagnostic test for brucellosis, with negative
results.
For a flock containing up to 1,000 animals, the sample must include:
a) all non-castrated males over 6 months of age;
b) all the animals introduced into the flock since the previous test;
c) 25% of the pubescent females; the number of females included in the sample should not be less
than 50, unless the flock contains fewer than 50 females, in which case all pubescent females
should be included.
For a flock containing more than 1,000 animals, a serological survey should be carried out every year
on a representative sample of the animals in the flock sufficient to provide a 99% level of confidence
of detecting caprine and ovine brucellosis if it is present at a prevalence rate exceeding 0.2%.
Control tests must be carried out at up to 3-year intervals if the flock is situated in a zone where 99%
of flocks are officially free from caprine and ovine brucellosis and the remainder are submitted to an
eradication programme.
However, for flocks situated in a country or zone qualified as officially free under point 1)d) of
Article 2.4.2.2., maintenance testing is not required.
Whatever the periodicity of control tests and the way the status has been obtained, sheep and goats
must only be introduced into the flocks in conformity with the provisions of Article 2.4.2.5.
3. Suspension and recovery of officially free status
If a sheep or goat reacts positively to a diagnostic test for caprine and ovine brucellosis, the status of
flock officially free from brucellosis shall be suspended and may not be recovered unless the
following requirements have been fulfilled:
a) all infected and in-contact animals were eliminated from the flock as soon as the result of the
diagnostic test was known;
b) all the remaining sheep and goats in the flock over 6 months of age on the day of sampling have
been subjected to a diagnostic test for caprine and ovine brucellosis, with negative results, on
two occasions, at an interval of not less than 3 months.
Article 2.4.2.4.
1. Qualification
To qualify as free from caprine and ovine brucellosis, a sheep or goat flock must satisfy the following
requirements:
a) it is under official veterinary control;
b) no clinical, bacteriological or immunological evidence of caprine and ovine brucellosis has been
found for at least one year;
c) if all or some of the sheep or goats have been vaccinated against caprine and ovine brucellosis,
this was performed before 7 months of age;
d) all non-vaccinated sheep and goats over 6 months of age, and all vaccinated ones over
18 months of age on the day of sampling have been subjected to a diagnostic test for brucellosis
with negative results on two occasions, at an interval of not more than 12 months and not less
than 6 months;
e) when qualified, it contains only sheep and goats born therein or introduced in conformity with
the provisions of Article 2.4.2.6.
2. Maintenance of free status
For a flock to maintain its status as free from caprine and ovine brucellosis, a sample of the animals
in the flock must be subjected each year to a diagnostic test for brucellosis with negative results.
For a flock containing up to 1,000 animals, the sample should include:
a) all non-castrated males over 18 months of age if vaccinated, and over 6 months of age if
unvaccinated;
b) all animals introduced into the flock since the previous control;
c) 25% of the pubescent females except vaccinated females less than 18 months of age; the
number of females included in the sample should not be less than 50, unless the flock contains
fewer than 50 females, in which case all pubescent females should be included in the sample.
For a flock containing more than 1,000 animals, a serological survey should be carried out every year
on a representative sample of the animals in the flock, excluding vaccinated females less than
18 months of age, sufficient to provide a 99% level of confidence of detecting caprine and ovine
brucellosis if it is present at a prevalence rate exceeding 0.2%.
Sheep and goats must only be introduced into the flock in conformity with the provisions of
Article 2.4.2.6.
3. Suspension and recovery of free status
If a sheep or goat over 18 months of age, if vaccinated, or over 6 months of age, if not vaccinated,
reacts positively to a diagnostic test for caprine and ovine brucellosis, the status of flock free from
brucellosis shall be suspended, and may not be recovered unless the following requirements have
been fulfilled:
a) all infected and in-contact animals were eliminated from the flock as soon as the result of the
diagnostic test was known;
b) all the remaining sheep and goats in the flock over 18 months of age if vaccinated, and over
6 months of age if not vaccinated on the day of sampling, have been subjected to a diagnostic
test for caprine and ovine brucellosis with negative results on two occasions, at an interval of
not less than 3 months.
4. Change of status
For a flock free from caprine and ovine brucellosis to qualify as officially free, the flock must fulfil
the following requirements for at least 2 years:
a) it has been free from caprine and ovine brucellosis;
b) vaccination against brucellosis has not been practised;
c) any sheep or goats introduced into the flock satisfied the provisions of Article 2.4.2.5.;
and at the end of the period, all sheep and goats over 6 months of age on the day of sampling have
been subjected to a diagnostic test for caprine and ovine brucellosis, with negative results.
Article 2.4.2.5.
Article 2.4.2.6.
Article 2.4.2.7.
Article 2.4.2.8.
b) were kept in a sheep or goat flock officially free from caprine and ovine brucellosis; or
c) were kept in a sheep or goat flock free from caprine and ovine brucellosis, and were subjected
to two different diagnostic tests for caprine and ovine brucellosis on the same blood sample
with negative results during the 30 days prior to collection;
2. the semen was collected, processed and stored in conformity with the provisions of Appendix 3.2.1.
Article 2.4.2.9.
CONTAGIOUS AGALACTIA
Article 2.4.3.1.
CAPRINE ARTHRITIS/ENCEPHALITIS
Article 2.4.4.1.
Article 2.4.4.2.
MAEDI-VISNA
Article 2.4.5.1.
Article 2.4.5.2.
Article 2.4.6.1.
For the purposes of this Terrestrial Code, contagious caprine pleuropneumonia (CCPP) is defined as a
disease of goats caused by Mycoplasma capricolum subsp. capripneumoniae. The incubation period for the
disease shall be 45 days (chronic carriers occur).
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.4.6.2.
A country may be considered free from CCPP when it has been shown that CCPP is not present and that
one year has elapsed after the slaughter of the last affected animal for countries in which a stamping-out
policy is practised.
Article 2.4.6.3.
A zone shall be considered as infected with CCPP until at least 45 days have elapsed after the
confirmation of the last case and the completion of a stamping-out policy and disinfection procedures.
Article 2.4.6.4.
Veterinary Administrations of CCPP free countries may prohibit importation or transit through their
territory, from countries considered infected with CCPP, of domestic and wild goats, and may prohibit
importation into their territory, from countries considered infected with CCPP, of semen of domestic and
wild goats and of embryos/ova of domestic goats.
Article 2.4.6.5.
When importing from CCPP free countries, Veterinary Administrations should require:
for domestic goats
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of CCPP on the day of shipment;
2. were kept in a CCPP free country since birth or for at least 3 months.
Article 2.4.6.6.
When importing from CCPP free countries, Veterinary Administrations should require:
Article 2.4.6.7.
When importing from countries considered infected with CCPP, Veterinary Administrations should
require:
for domestic goats
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of CCPP on the day of shipment;
2. were subjected to a complement fixation test for CCPP with negative results, on two occasions, with
an interval of not less than 21 days and not more than 30 days between each test, the second test
being performed within 14 days prior to shipment (under study);
3. were isolated from other domestic goats from the day of the first complement fixation test until
shipment;
4. were kept since birth, or for at least the past 45 days, in an establishment where no case of CCPP was
officially reported during that period, and that the establishment of origin was not situated in a CCPP
infected zone;
5. have not been vaccinated against CCPP; or
6. were vaccinated not more than 4 months prior to shipment. In this case, point 2) above is not
required (under study).
Article 2.4.6.8.
When importing from countries considered infected with CCPP, Veterinary Administrations should
require:
for goats for immediate slaughter
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of CCPP on the day of shipment;
2. were kept since birth, or for at least the past 45 days, in an establishment where no case of CCPP was
officially reported during that period, and that the establishment of origin was not situated in a CCPP
infected zone.
Article 2.4.6.9.
When importing from countries considered infected with CCPP, Veterinary Administrations should
require:
Article 2.4.6.10.
When importing from countries considered infected with CCPP, Veterinary Administrations should
require:
for fresh meat of goats
the presentation of an international veterinary certificate attesting that the entire consignment of meat comes
from animals:
1. which originate from establishments free of CCPP;
2. which have been slaughtered in an approved abattoir and have been subjected to an ante-mortem
inspection for CCPP with favourable results; and
3. which showed no lesion of CCPP at the post-mortem inspection.
Article 2.4.7.1.
For the purposes of this Terrestrial Code, the following information should be considered with regard to
the incubation period for enzootic abortion of ewes (EAE).
Susceptible animals become infected through ingestion of infectious materials. In lambs and
non-pregnant ewes, the infection remains latent until conception. Ewes exposed to infection late in
pregnancy may not exhibit signs of infection until the subsequent pregnancy. Countries should take
account of these risk factors.
Standards for diagnostic tests are described in the Terrestrial Manual.
Article 2.4.7.2.
Article 2.4.7.3.
To qualify as free from EAE infection, a sheep flock or goat herd shall satisfy the following requirements:
1. it is under official veterinary surveillance;
2. all sheep and goats showed no clinical evidence of EAE infection during the past 2 years;
3. a statistically valid number of sheep and goats over 6 months of age were subjected to a diagnostic
test for EAE with negative results within the past 6 months;
4. all sheep or goats are permanently identified;
5. no sheep or goat has been added to the flock or herd since 30 days prior to the flock or herd test
referred to in point 3) above unless:
a) either the additions were isolated from other members of the flock or herd in the establishment
of origin for a minimum period of 30 days and then were subjected to a diagnostic test for EAE
with negative results, before entry into the new flock or herd; or
b) they originated from an establishment of equal health status.
Article 2.4.7.4.
SCRAPIE
Article 2.4.8.1.
Scrapie is a neurodegenerative disease of sheep and goats. The main mode of transmission is from mother
to offspring immediately after birth and to other susceptible neonates exposed to the birth fluids and
tissues of an infected animal. Transmission occurs at a much lower frequency to adults exposed to the
birth fluids and tissues of an infected animal. A variation in genetic susceptibility of sheep has been
recognised. The incubation period of the disease is variable, however it is usually measured in years. The
duration in incubation period can be influenced by a number of factors including host genetics and strain of
agent.
The recommendations in the present chapter are not intended, or sufficient, to manage the risks
associated with the potential presence of the bovine spongiform encephalopathy agent in small ruminants.
Standards for diagnostic tests are described in the Terrestrial Manual.
Article 2.4.8.2.
The scrapie status of a country, a zone or an establishment can be determined on the basis of the following
criteria:
1. the outcome of a risk assessment identifying all potential factors for scrapie occurrence and their
historic perspective, in particular the:
a) epidemiological situation concerning all animal transmissible spongiform encephalopathies
(TSE) in the country, zone or establishment;
b) importation or introduction of small ruminants or their embryos/oocytes potentially infected
with scrapie;
c) extent of knowledge of the population structure and husbandry practices of sheep and goats in
the country or zone;
d) feeding practices, including consumption of meat-and-bone meal or greaves derived from
ruminants;
e) importation of meat-and-bone meal or greaves potentially contaminated with an animal TSE or
feedstuffs containing either;
f) the origin and use of ruminant carcasses (including fallen stock), by-products and
slaughterhouse waste, the parameters of the rendering processes and the methods of animal
feed manufacture;
2. an on-going awareness programme for veterinarians, farmers, and workers involved in
transportation, marketing and slaughter of sheep and goats to facilitate recognition and encourage
reporting of all animals with clinical signs compatible with scrapie;
3. a surveillance and monitoring system including the following:
a) official veterinary surveillance, reporting and regulatory control in accordance with the
provisions of Chapter 3.8.1.;
b) a Veterinary Administration with current knowledge of, and authority over, all establishments
which contain sheep and goats in the whole country;
c) compulsory notification and clinical investigation of all sheep and goats showing clinical signs
compatible with scrapie;
d) examination in an approved laboratory of appropriate material from sheep and goats older than
18 months displaying clinical signs compatible with scrapie taking into account the guidelines in
Appendix X.X.X. (under study);
e) maintenance of records including the number and results of all investigations for at least 7 years.
Article 2.4.8.3.
Countries or zones may be considered free from scrapie if within the said territory:
1. a risk assessment, as described in point 1) of Article 2.4.8.2., has been conducted, and it has been
demonstrated that appropriate measures have been taken for the relevant period of time to manage
any risk identified;
AND EITHER
2. the country or the zone have demonstrated historical freedom taking into account the guidelines in
Appendix 3.8.6.;
OR
3. for at least 7 years, a surveillance and monitoring system as referred to in Article 2.4.8.2. has been in
place, and no case of scrapie has been reported during this period;
OR
4. for at least 7 years, a sufficient number of investigations has been carried out annually, to provide a
95% level of confidence of detecting scrapie if it is present at a prevalence rate exceeding 0.1% out
of the total number of all chronic wasting conditions in the population of sheep and goats older than
18 months of age (under study) and no case of scrapie has been reported during this period; it is
assumed that the occurrence rate of chronic wasting conditions within the population of sheep and
goats older than 18 months of age is at least 1%;
OR
5. all establishments containing sheep or goats have been accredited free as described in Article 2.4.8.4.;
AND
6. the feeding to sheep and goats of meat-and-bone meal or greaves potentially contaminated with an
animal TSE has been banned and effectively enforced in the whole country for at least 7 years;
AND
7. introductions of sheep and goats, semen and embryos/oocytes from countries or zones not free
from scrapie are carried out in accordance with Articles 2.4.8.6., 2.4.8.7., 2.4.8.8. or 2.4.8.9., as
relevant.
For maintenance of country or zone free status, the investigations referred to in point 4) above should be
repeated every 7 years.
Article 2.4.8.4.
An establishment may be considered eligible for accreditation as a scrapie free establishment if:
1. in the country or zone where the establishment is situated, the following conditions are fulfilled:
a) the disease is compulsorily notifiable;
b) a surveillance and monitoring system as referred to in Article 2.4.8.2. is in place;
c) affected sheep and goats are slaughtered and completely destroyed;
d) the feeding to sheep and goats of meat-and-bone meal or greaves potentially contaminated with an
animal TSE has been banned and effectively enforced in the whole country;
e) an official accreditation scheme is in operation under the supervision of the Veterinary
Administration, including the measures described in point 2) below;
2. in the establishment the following conditions have been complied with for at least 7 years:
a) sheep and goats should be permanently identified and records maintained, to enable trace back
to their establishment of birth;
b) records of movements of sheep and goats in and out of the establishment are established and
maintained;
c) introductions of animals are allowed only from establishments of an equal or higher stage in the
process of accreditation; however, rams and bucks complying with the provisions in point 2) of
Article 2.4.8.8. may also be introduced;
d) an Official Veterinarian inspects sheep and goats in the establishment and audits the records at
least once a year;
e) no case of scrapie has been reported;
f) sheep and goats of the establishment should have no direct or indirect contact with sheep or
goats from establishments of a lower status;
g) all culled animals over 18 months of age are inspected by an Official Veterinarian, and a
proportion of those exhibiting neurological or wasting signs are tested in a laboratory for
scrapie. The selection of the animals to be tested should be made by the Official Veterinarian.
Animals over 18 months of age that have died or have been killed for reasons other than
routine slaughter should also be tested (including ‘fallen’ stock and emergency slaughter).
Article 2.4.8.5.
Regardless of the scrapie status of the exporting country, Veterinary Administrations should authorise
without restriction the import or transit through their territory of meat (excluding materials as referred to
in Article 2.4.8.11.), milk, milk products, wool and its derivatives, hides and skins, tallow, derivatives made
from this tallow and dicalcium phosphate originating from sheep and goats.
Article 2.4.8.6.
When importing from countries not considered free from scrapie, Veterinary Administrations should
require:
for sheep and goats for breeding or rearing
the presentation of an international veterinary certificate attesting that the animals come from a zone or an
establishment free from scrapie as described in Article 2.4.8.3. and in Article 2.4.8.4.
Article 2.4.8.7.
When importing from countries or zones not considered free from scrapie, Veterinary Administrations
should require:
for sheep and goats for slaughter
the presentation of an international veterinary certificate attesting that:
1. in the country or zone:
a) the disease is compulsorily notifiable;
b) a surveillance and monitoring system as referred to in Article 2.4.8.2. is in place;
c) affected sheep and goats are slaughtered and completely destroyed;
2. the sheep and goats selected for export showed no clinical sign of scrapie on the day of shipment.
Article 2.4.8.8.
When importing from countries or zones not considered free from scrapie, Veterinary Administrations
should require:
for semen of sheep and goats
the presentation of an international veterinary certificate attesting that:
1. in the country or zone:
a) the disease is compulsorily notifiable;
b) a surveillance and monitoring system as referred to in Article 2.4.8.2. is in place;
c) affected sheep and goats are slaughtered and completely destroyed;
d) the feeding of sheep and goats with meat-and-bone meal or greaves potentially contaminated with
an animal TSE has been banned and effectively enforced in the whole country;
2. the donor animals:
a) are permanently identified, to enable trace back to their establishment of origin;
b) have been kept since birth in establishments in which no case of scrapie had been confirmed
during their residency;
c) showed no clinical sign of scrapie at the time of semen collection;
3. the semen was collected, processed and stored in conformity with the provisions of Appendix 3.2.1.
Article 2.4.8.9.
When importing from countries or zones not considered free from scrapie, Veterinary Administrations
should require:
for embryos/oocytes of sheep and goats
the presentation of an international veterinary certificate attesting that:
1. in the country or zone:
a) the disease is compulsorily notifiable;
b) a surveillance and monitoring system as referred to in Article 2.4.8.2. is in place;
c) affected sheep and goats are slaughtered and completely destroyed;
d) the feeding to sheep and goats of meat-and-bone meal or greaves potentially contaminated with
animal TSE has been banned and effectively enforced in the whole country;
b) have been kept since birth in establishments in which no case of scrapie had been confirmed
during their residency;
3. the embryos/oocytes were collected, processed and stored in conformity with the provisions of
Appendix 3.3.1.
Article 2.4.8.10.
Meat-and-bone meal containing any sheep or goat protein, or any feedstuffs containing that type of
meat-and-bone meal, which originate from countries not considered free of scrapie should not be traded
between countries for ruminant feeding.
Article 2.4.8.11.
When importing from countries or zones not considered free from scrapie, Veterinary Administrations
should require:
for skulls including brains, ganglia and eyes, vertebral column including ganglia and spinal cord, tonsils,
thymus, spleen, intestine, adrenal gland, pancreas, or liver, and protein products derived therefrom, from
sheep and goats
2. the materials come from sheep and goats that showed no clinical sign of scrapie on the day of
slaughter.
Article 2.4.8.12.
for ovine and caprine materials destined for the preparation of biologicals
the presentation of an international veterinary certificate attesting that the products originate from sheep and
goats born and raised in a scrapie free country, zone or establishment.
Article 2.4.9.1.
For the purposes of this Terrestrial Code, the incubation period for the peste des petits ruminants (PPR) shall
be 21 days.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.4.9.2.
A country may be considered free from PPR when it has been shown that PPR has not been present for
at least the past 3 years.
This period shall be 6 months after the slaughter of the last affected animal for countries in which a
stamping-out policy is practised with or without vaccination against PPR.
Article 2.4.9.3.
Article 2.4.9.4.
Veterinary Administrations of PPR free countries may prohibit importation or transit through their
territory, from countries considered infected with PPR, of the following commodities:
1. domestic and wild ruminants;
2. semen of ruminants;
3. embryos/ova of ruminants;
4. fresh meat of domestic and wild ruminants;
5. meat products of domestic and wild ruminants which have not been processed to ensure the
destruction of the PPR virus;
6. products of animal origin (from ruminants) intended for use in animal feeding or for agricultural or
industrial use which have not been processed to ensure the destruction of the PPR virus;
7. products of animal origin (from ruminants) intended for pharmaceutical or surgical use which have
not been processed to ensure the destruction of the PPR virus;
8. pathological material and biological products (from ruminants) which have not been processed to
ensure the destruction of the PPR virus.
Article 2.4.9.5.
When importing from PPR free countries, Veterinary Administrations should require:
for domestic small ruminants
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of PPR on the day of shipment;
2. were kept in a PPR free country since birth or for at least the past 21 days.
Article 2.4.9.6.
When importing from PPR free countries, Veterinary Administrations should require:
for wild ruminants
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of PPR on the day of shipment;
2. come from a PPR free country;
if the country of origin has a common border with a country considered infected with PPR:
3. were kept in a quarantine station for the 21 days prior to shipment.
Article 2.4.9.7.
When importing from countries considered infected with PPR, Veterinary Administrations should require:
for domestic small ruminants
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of PPR on the day of shipment;
2. were kept since birth, or for the past 21 days, in an establishment where no case of PPR was officially
reported during that period, and that the establishment was not situated in a PPR infected zone;
and/or
3. were kept in a quarantine station for the 21 days prior to shipment;
4. have not been vaccinated against PPR; or
5. were vaccinated against PPR:
a) not less than 15 days and not more than 4 months prior to shipment in the case of animals for
breeding or rearing; or
b) not less than 15 days and not more than 12 months prior to shipment in the case of animals for
slaughter.
Article 2.4.9.8.
When importing from countries considered infected with PPR, Veterinary Administrations should require:
Article 2.4.9.9.
When importing from PPR free countries, Veterinary Administrations should require:
for semen of domestic small ruminants
the presentation of an international veterinary certificate attesting that the donor animals:
1. showed no clinical sign of PPR on the day of collection of the semen and during the following
21 days;
2. were kept in a PPR free country for not less than 21 days prior to collection.
Article 2.4.9.10.
When importing from countries considered infected with PPR, Veterinary Administrations should require:
for semen of domestic small ruminants
the presentation of an international veterinary certificate attesting that the donor animals:
1. showed no clinical sign of PPR on the day of collection of the semen and during the following
21 days;
2. were kept in the exporting country for the 21 days prior to collection, in an establishment or artificial
insemination centre where no case of PPR was officially reported during that period, and that the
establishment or artificial insemination centre was not situated in a PPR infected zone;
3. have not been vaccinated against PPR; or
4. were vaccinated against PPR.
Article 2.4.9.11.
When importing from PPR free countries, Veterinary Administrations should require:
for embryos of domestic small ruminants and cervids
the presentation of an international veterinary certificate attesting that:
1. the donor females were kept in an establishment located in a PPR free country at the time of collection
of the embryos;
2. the embryos were collected, processed and stored in conformity with the provisions of
Appendix 3.3.1.
Article 2.4.9.12.
When importing from countries considered infected with PPR, Veterinary Administrations should require:
Article 2.4.9.13.
When importing from PPR free countries, Veterinary Administrations should require:
for fresh meat or meat products of domestic small ruminants
the presentation of an international veterinary certificate attesting that the entire consignment of meat comes
from animals:
1. which have been kept in the country since birth, or have been imported from a PPR free country;
2. which have been slaughtered in an approved abattoir and have been subjected to ante-mortem and
post-mortem inspections for PPR with favourable results.
Article 2.4.9.14.
When importing from countries considered infected with PPR, Veterinary Administrations should require:
for meat products of domestic small ruminants
the presentation of an international veterinary certificate attesting that:
1. the entire consignment of meat products comes from animals which have been slaughtered in an
approved abattoir and have been subjected to ante-mortem and post-mortem inspections for PPR with
favourable results;
2. the meat products have been processed to ensure the destruction of the PPR virus;
3. the necessary precautions were taken after processing to avoid contact of the meat with any source
of PPR virus.
Article 2.4.9.15.
When importing from PPR free countries, Veterinary Administrations should require:
for products of animal origin (from small ruminants) intended for use in animal feeding or for agricultural
or industrial use
the presentation of an international veterinary certificate attesting that these products come from animals
which have been kept in a PPR free country since birth or for at least the past 21 days.
Article 2.4.9.16.
When importing from PPR free countries, Veterinary Administrations should require:
for products of animal origin (from small ruminants) intended for pharmaceutical or surgical use
the presentation of an international veterinary certificate attesting that these products come from animals:
1. which have been kept in a PPR free country since birth or for at least the past 21 days;
2. which have been slaughtered in an approved abattoir and have been subjected to ante-mortem and
post-mortem inspections for PPR with favourable results.
Article 2.4.9.17.
When importing from countries considered infected with PPR, Veterinary Administrations should require:
for meal and flour from blood, meat, defatted bones, hooves, claws and horns (from small ruminants)
the presentation of an international veterinary certificate attesting that these products have been processed
using heat treatment to ensure the destruction of the PPR virus.
Article 2.4.9.18.
When importing from countries considered infected with PPR, Veterinary Administrations should require:
for hooves, claws, bones and horns, hunting trophies and preparations destined for museums (from small
ruminants)
the presentation of an international veterinary certificate attesting that these products:
1. were completely dried and had no trace on them of skin, flesh or tendon; and/or
2. have been adequately disinfected.
Article 2.4.9.19.
When importing from countries considered infected with PPR, Veterinary Administrations should require:
for wool, coarse hair and other hair (from small ruminants)
the presentation of an international veterinary certificate attesting that these products:
1. come from animals which have not been kept in a PPR infected zone; or
2. have been processed to ensure the destruction of the PPR virus, in premises controlled and
approved by the Veterinary Administration of the exporting country.
Article 2.4.9.20.
When importing from countries considered infected with PPR, Veterinary Administrations should require:
for raw hides and skins (from small ruminants)
the presentation of an international veterinary certificate attesting that these products:
1. come from animals which have not been kept in a PPR infected zone; or
2. have been adequately disinfected.
Article 2.4.9.21.
When importing from countries considered infected with PPR, Veterinary Administrations should require:
for products of animal origin (from small ruminants) intended for pharmaceutical or surgical use
the presentation of an international veterinary certificate attesting that these products:
1. have been processed to ensure the destruction of the PPR virus; or
2. come from animals which did not come from a PPR infected zone;
3. come from animals which have been slaughtered in an approved abattoir and have been subjected to
ante-mortem and post-mortem inspections for PPR with favourable results.
Article 2.4.10.1.
For the purposes of this Terrestrial Code, the incubation period for sheep pox and goat pox shall be 21 days.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.4.10.2.
A country may be considered free from sheep pox and goat pox when it has been shown that sheep pox
and goat pox has not been present for at least the past 3 years.
This period shall be 6 months after the slaughter of the last affected animal for countries in which a
stamping-out policy is practised with or without vaccination against sheep pox and goat pox.
Article 2.4.10.3.
A zone shall be considered as infected with sheep pox and/or goat pox until:
1. at least 21 days have elapsed after the confirmation of the last case and the completion of a
stamping-out policy and disinfection procedures, or
2. 6 months have elapsed after the clinical recovery or death of the last affected animal if a stamping-out
policy was not practised.
Article 2.4.10.4.
Veterinary Administrations of sheep pox and goat pox free countries may prohibit importation or transit
through their territory, from countries considered infected with sheep pox and goat pox, of domestic
sheep and goats.
Article 2.4.10.5.
When importing from sheep pox and goat pox free countries, Veterinary Administrations should require:
for domestic sheep and goats
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of sheep pox or goat pox on the day of shipment;
2. were kept in a sheep pox and goat pox free country since birth or for at least the past 21 days.
Article 2.4.10.6.
When importing from countries considered infected with sheep pox and goat pox, Veterinary
Administrations should require:
for domestic sheep and goats
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of sheep pox or goat pox on the day of shipment;
2. were kept since birth, or for the past 21 days, in an establishment where no case of sheep pox and goat
pox was officially reported during that period, and that the establishment was not situated in a sheep
pox and goat pox infected zone; or
3. were kept in a quarantine station for the 21 days prior to shipment;
4. have not been vaccinated against sheep pox and goat pox; or
5. were vaccinated using a vaccine complying with the standards described in the Terrestrial Manual not
less than 15 days and not more than 4 months prior to shipment (the nature of the vaccine used,
whether inactivated or modified live virus, and the virus types and strains included in the vaccine
shall also be stated in the certificate).
Article 2.4.10.7.
When importing from sheep pox and goat pox free countries, Veterinary Administrations should require:
for semen of sheep and goats
the presentation of an international veterinary certificate attesting that the donor animals:
1. showed no clinical sign of sheep pox or goat pox on the day of collection of the semen and for the
following 21 days;
2. were kept in a sheep pox and goat pox free country.
Article 2.4.10.8.
When importing from countries considered infected with sheep pox and goat pox, Veterinary
Administrations should require:
for semen of sheep and goats
the presentation of an international veterinary certificate attesting that the donor animals:
1. showed no clinical sign of sheep pox or goat pox on the day of collection of the semen and for the
following 21 days;
2. were kept in the exporting country for the 21 days prior to collection, in an establishment or artificial
insemination centre where no case of sheep pox and goat pox was officially reported during that period,
and that the establishment or artificial insemination centre was not situated in a sheep pox and goat pox
infected zone;
3. have not been vaccinated against sheep pox and goat pox; or
4. were vaccinated using a vaccine complying with the standards described in the Terrestrial Manual (the
nature of the vaccine used, whether inactivated or modified live virus, and the virus types and strains
included in the vaccine shall also be stated in the certificate).
Article 2.4.10.9.
When importing from countries considered infected with sheep pox and goat pox, Veterinary
Administrations should require:
for skins, fur, wool and hair (from sheep or goats)
the presentation of an international veterinary certificate attesting that these products:
1. come from animals which have not been kept in a sheep pox and goat pox infected zone; or
2. have been processed to ensure the destruction of the sheep pox and goat pox virus, in premises
controlled and approved by the Veterinary Administration of the exporting country.
EQUINE DISEASES
CHAPTER 2.5.1.
Article 2.5.1.1.
For the purposes of this Chapter, 'infected establishment' means premises in which equines infected with
contagious equine metritis (CEM) are kept. The establishment shall be considered infected until 2 months
have elapsed since the confirmation of the last case and after the premises have been adequately cleansed
and disinfected.
Standards for diagnostic tests are described in the Terrestrial Manual.
Article 2.5.1.2.
Article 2.5.1.3.
2. have been protected against any possibility of contagion since the beginning of the tests.
DOURINE
Article 2.5.2.1.
For the purposes of this Terrestrial Code, the incubation period for dourine shall be 6 months.
Standards for diagnostic tests are described in the Terrestrial Manual.
Article 2.5.2.2.
A country formerly infected with dourine may be considered free again when:
1. a stamping-out policy has been practised for affected animals;
2. no clinical case of dourine has been observed during the past 2 years;
3. breeding horses have been subjected to a diagnostic test for dourine with negative results performed
annually over a 2-year period.
Article 2.5.2.3.
When importing from dourine free countries for the past 6 months, Veterinary Administrations should
require:
for equines
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of dourine on the day of shipment;
2. were kept since birth, or for the 6 months prior to shipment, in a country which has been free from
dourine for not less than the past 6 months.
Article 2.5.2.4.
When importing from countries considered infected with dourine, Veterinary Administrations should
require:
for equines
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of dourine on the day of shipment;
2. were kept for the 6 months prior to shipment in an establishment where no case of dourine was
officially reported during that period;
3. were subjected to a diagnostic test for dourine with negative results during the 15 days prior to
shipment.
Article 2.5.2.5.
When importing from dourine free countries for the past 6 months, Veterinary Administrations should
require:
for semen of equines
the presentation of an international veterinary certificate attesting that the donor animals were kept since
birth, or for the 6 months prior to collection of the semen, in a country which has been free from dourine
for not less than the past 6 months.
Article 2.5.2.6.
When importing from countries considered infected with dourine, Veterinary Administrations should
require:
for semen of equines
the presentation of an international veterinary certificate attesting that:
1. the donor animals:
a) were kept for the 6 months prior to collection of the semen in an establishment or artificial
insemination centre where no case of dourine was reported during that period;
b) were subjected to a diagnostic test for dourine with negative results;
2. the microscopic examination of the semen for dourine was negative.
EQUINE ENCEPHALOMYELITIS
(Eastern and Western)
Article 2.5.3.1.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.5.3.2.
Article 2.5.4.1.
Article 2.5.4.2.
1. the animals showed no clinical sign of equine infectious anaemia (EIA) on the day of shipment and
during the 48 hours prior to shipment;
2. for breeding animals only, no case of EIA has been associated with any premises where the animals
were kept during the 3 months prior to shipment;
3. the animals were subjected to a diagnostic test for EIA with negative results during the 30 days prior
to shipment.
Article 2.5.4.3.
1. the animals showed no clinical sign of EIA on the day of shipment and during the 48 hours prior to
shipment;
2. no case of EIA has been associated with any premises where the animals were kept during the
3 months prior to shipment;
3. the animals were subjected to a diagnostic test for EIA with negative results during the 30 days prior
to shipment (the negative response to the serological test remains valid for 120 days).
EQUINE INFLUENZA
Article 2.5.5.1.
For the purposes of this Terrestrial Code, the infective period for equine influenza shall be 14 days and the
incubation period 5 days.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.5.5.2.
1. Qualification
To qualify as free from equine influenza, a country must satisfy the following requirements:
a) the disease is notifiable;
b) vaccination against equine influenza is not authorised, except for equines intended for export;
c) no clinical case of the disease has been reported for at least one year;
d) a serological survey has been carried out on a representative sample of the equine population of
the country (excluding imported vaccinated equines) sufficient to provide at least a 99% level of
confidence of detecting the disease if it is present at a prevalence rate exceeding 5%.
2. Maintenance of free status
For a country to maintain its status as free from equine influenza:
a) no clinical case of the disease has been reported since the achievement of the serological survey
referred to in point 1)d) above;
b) all imported equines comply with the provisions of Article 2.5.5.3.
Article 2.5.5.3.
d) the animals have been vaccinated in accordance with the recommendations in the Terrestrial
Manual.
EQUINE PIROPLASMOSIS
Article 2.5.6.1.
Article 2.5.6.2.
for equines
2. were subjected to diagnostic tests for equine piroplasmosis (Babesia equi and B. caballi) with negative
results during the 30 days prior to shipment;
3. were treated against ticks within the 7 days prior to shipment (the importing country may decide to
import only during seasons when ticks are not active on its territory).
Article 2.5.6.3.
Veterinary Administrations of importing countries should consider the possibility of importing competition
horses on a temporary basis and which are positive to the testing procedure referred to in point 2) of
Article 2.5.6.2. under the following safeguards:
1. the horses are accompanied by a passport in conformity with the model contained in
Appendix 4.1.5.;
3. the horses are kept in an area where necessary precautions are taken to control ticks and that is under
the direct supervision of the Veterinary Authority;
4. the horses are regularly examined for the presence of ticks under the direct supervision of the
Veterinary Authority.
EQUINE RHINOPNEUMONITIS
Article 2.5.7.1.
Article 2.5.7.2.
GLANDERS
Article 2.5.8.1.
For the purposes of this Terrestrial Code, the incubation period for glanders shall be 6 months.
Standards for diagnostic tests are described in the Terrestrial Manual.
Article 2.5.8.2.
Article 2.5.8.3.
When importing from glanders free countries, Veterinary Administrations should require:
for equines
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical evidence of glanders on the day of shipment;
2. were kept since birth, or for the past 6 months prior to shipment, in the exporting country; or
3. were subjected to the mallein test and/or the complement fixation test for glanders with negative
results during the 15 days prior to shipment.
Article 2.5.8.4.
When importing from countries considered infected with glanders, Veterinary Administrations should
require:
for equines
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of glanders on the day of shipment;
2. were kept for the 6 months prior to shipment in an establishment where no case of glanders was
officially reported during that period;
3. were subjected to the mallein test and the complement fixation test for glanders with negative results
during the 15 days prior to shipment.
Article 2.5.8.5.
When importing from countries considered infected with glanders, Veterinary Administrations should
require:
for equines for immediate slaughter
the presentation of an international veterinary certificate attesting that the animals showed no clinical sign of
glanders on the day of shipment. (See also Article 2.5.8.2.)
HORSE POX
Article 2.5.9.1.
Article 2.5.10.1.
The infective period for equine viral arteritis (EVA) shall be 28 days for mares and geldings. The health
status of seropositive stallions should be checked to ensure that they do not shed equine arteritis virus in
their semen.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.5.10.2.
Article 2.5.10.3.
Article 2.5.10.4.
the presentation of an international veterinary certificate attesting that the animal donors:
1. were kept for the 30 days prior to semen collection in an establishment where no equine has shown
any clinical sign of EVA during that period;
3. were subjected between 6 and 12 months of age to a diagnostic test for EVA on a blood sample with
negative results, immediately vaccinated for EVA and regularly revaccinated; or
4. were subjected to a diagnostic test for EVA on a blood sample with negative results within 14 days
prior to semen collection, and had not been used for natural breeding from the time of the taking of
the blood sample to the time of semen collection; or
5. have been subjected to a diagnostic test for EVA with positive results and then:
a) either were test mated within one year prior to semen collection to two mares which showed
negative results to two diagnostic tests on blood samples collected at the time of test mating
and again 28 days after the test mating,
b) or were subjected to a virus isolation test with negative results (under study), carried out on
semen collected within one year prior to collection of the semen to be exported.
Article 2.5.10.5.
the presentation of an international veterinary certificate attesting that the animal donors:
2. were subjected to a diagnostic test for EVA on a blood sample with negative results not less than
14 days after semen collection; or
3. were subjected between 6 and 12 months of age to a diagnostic test for EVA on a blood sample with
negative results, immediately vaccinated for EVA and regularly revaccinated; or
4. have been subjected to a diagnostic test for EVA with positive results and then:
a) either were test mated within one year prior to, or as soon as possible after, semen collection to
two mares which showed negative results to two diagnostic tests on blood samples collected at
the time of test mating and again 28 days after the test mating;
b) or were subjected to a virus isolation test with negative results (under study), carried out on
semen collected within one year prior to collection of the semen to be exported, or on the
semen to be exported.
HORSE MANGE
Article 2.5.11.1.
Article 2.5.11.2.
Article 2.5.12.1.
For the purposes of this Terrestrial Code, the infective period for Venezuelan equine encephalomyelitis
(VEE) shall be 14 days, and the incubation period 5 days.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.5.12.2.
Article 2.5.12.3.
Veterinary Administrations of VEE free countries may prohibit importation or transit through their
territory, from countries considered infected with VEE, of domestic and wild equines, and may prohibit
the importation into their territory, from countries considered infected with VEE, of semen and
embryos/ova of domestic and wild equines.
Article 2.5.12.4.
When importing from VEE free countries, the Veterinary Administrations of importing countries should
require:
for domestic and wild equines
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of VEE on the day of shipment;
2. have not, during the past 6 months, been in any country in which VEE has occurred in the last
2 years;
3. have not been vaccinated against VEE within 60 days prior to shipment.
Article 2.5.12.5.
When importing from countries considered infected with VEE, the Veterinary Administrations of importing
countries should require:
1. vaccinated animals:
a) were vaccinated against VEE not less than 60 days prior to shipment and were clearly identified
with a permanent mark at the time of vaccination;
b) were kept in a quarantine station in the country of origin under official veterinary supervision for
3 weeks prior to shipment and remained clinically healthy during that period; any animal which
showed a rise in temperature (taken daily) was subjected to a blood test for virus isolation, with
negative results;
c) were protected from insect vectors during transportation to and from the quarantine station and
during the quarantine period;
2. unvaccinated animals:
a) were kept in a quarantine station in the country of origin under official veterinary supervision for
3 weeks prior to shipment and remained clinically healthy during that period; any animal which
showed a rise in temperature (taken daily) was subjected to a blood test for virus isolation, with
negative results;
b) were subjected to a diagnostic test for VEE with negative results conducted not less than
14 days after the commencement of quarantine;
c) were protected from insect vectors during transportation to and from the quarantine station and
during the quarantine period;
In addition, animals may be isolated in the importing country for 7 days under official veterinary
supervision. Any animal which shows a rise in temperature (taken daily) shall be subjected to a blood test
for virus isolation.
EPIZOOTIC LYMPHANGITIS
Article 2.5.13.1.
Article 2.5.13.2.
Article 2.5.14.1.
For the purposes of this Terrestrial Code, the infective period for African horse sickness (AHS) shall be
40 days for domestic horses.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.5.14.2.
A country may be considered free from AHS when the disease is notifiable in the country, and when no
clinical, serological (in non-vaccinated animals) or epidemiological evidence of AHS has been found for
the past 2 years. Also, when no domestic horse or other equine has been vaccinated against the disease
during the past 12 months.
Article 2.5.14.3.
A zone of a country may be considered free from AHS when the disease is notifiable in the whole country
and when no clinical, serological (in non-vaccinated animals) or epidemiological evidence of AHS has
been found in the zone during the past 2 years. Also, when no domestic horse or other equine has been
vaccinated against the disease during the past 12 months. The free zone must be clearly delineated by
substantial geographical barriers if possible. The animal health regulations to prevent the movement of
domestic horses and other equines into the free zone from an infected country or infected zone must be
published and rigorously implemented, with notification to the OIE in conformity with the provisions of
Article 1.1.2.4. of Section 1.1. of this Terrestrial Code. Regular inspection and supervision of movement of
domestic horses and other equines should be made in the free zone to ensure freedom from AHS.
If an AHS free country or zone imports domestic horses or other equines from an infected country or
infected zone, the importing country or zone will not be considered infected, provided that the importation
has been carried out in conformity with the provisions of Article 2.5.14.8.
Article 2.5.14.4.
The boundary between the infected zone and a free country or zone shall not be limited by national
frontiers, must be clearly defined and must take account of geographical and ecological factors as well as
all epizootiological factors which are relevant to this disease. The area of the zone should be extended or
reduced if necessary to satisfy the following factors:
a) Epizootiology of the disease
AHS is a non-contagious disease. It can be readily transmitted by the parenteral injection of infective
blood or organ emulsion. The main natural mode of transmission is by female midges of the genus
Culicoides of which C. imicola appears to be the most significant vector. In areas with a temperate
climate, the peak incidence of disease occurs in the late summer and early autumn. Its prevalence is
directly influenced by climatic conditions favouring insect breeding and outbreaks are abruptly
curtailed by severe frost.
b) Ecological factors
A severe frost involving 3 periods of temperature of -3°C lasting a minimum of 2-3 hours each,
during a 3-week period (under study) would eliminate both adult midges and hatching larvae of
Culicoides species in the area. During an outbreak, the percentage of infected midges is extremely low.
Although an infected midge may harbour a relatively large amount of virus, the potential for spread
of disease by this means over long distances is extremely low.
c) Geographical factors
The activity of the midge vectors is significantly reduced at high altitudes. The presence of mountain
ranges at the boundary of an infected zone will provide a natural barrier to the movement of vectors.
Extensive areas of arid terrain would also serve as a natural barrier.
d) The factors to be taken into account in delineating the extent of an infected zone should include:
i) the presence or otherwise of the insect vector throughout the year;
ii) the presence or absence of frost severe enough to eliminate the vector;
iii) the presence of mountain ranges or areas of arid terrain acting as a natural barrier to the
movement of insect vectors.
Within and at the border of the infected zone there must be effective veterinary control of domestic
horses and other equines and their transportation. The regulations must be published and rigorously
implemented.
No domestic horse or other equine may be moved out of the infected zone except in conformity with the
provisions of Article 2.5.14.8.
All vaccinated domestic horses or other equines in the infected zone must be clearly identified with a
permanent mark at the time of vaccination.
A country or zone of a country may be restored to AHS free status if:
1. the disease has been notifiable in the whole country for at least 2 years;
2. no clinical, serological (in non-vaccinated animals) and/or epidemiological evidence of AHS has been
found in the country or zone during the last 2 years;
3. no equine has been vaccinated against the disease in the country or zone during the past 12 months;
4. no equine has been imported from infected countries or zones except in conformity with the
provisions of Article 2.5.14.8.;
5. a system making notifiable any mortality in equines has been in force for at least 2 years, and any
dead equine has been investigated so as to confirm the absence of AHS;
6. documented evidence that all the above conditions have been fulfilled should be sent to the OIE.
Article 2.5.14.5.
Veterinary Administrations of countries shall consider whether there is a risk with regard to AHS in
accepting importation or transit through their territory, from other countries, of the following commodities:
1. animals of the family of Equidae;
2. equine semen;
3. equine embryos.
Article 2.5.14.6.
When importing from AHS free countries or zones, Veterinary Administrations should require:
for domestic horses
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of AHS on the day of shipment;
2. have not been vaccinated against AHS within 2 months of export;
3. were kept in an AHS free country or zone since birth or for at least the past 2 months.
Article 2.5.14.7.
When importing from AHS free countries or zones, Veterinary Administrations should require:
for other equines
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of AHS on the day of shipment;
2. have not been vaccinated against AHS within 2 months of export;
3. were kept in an AHS free country or zone since birth or for at least the past 2 months;
if the animal originates from a zone or country adjacent to an infected zone or a country considered
infected with AHS:
4. were kept in a quarantine station for 60 days prior to shipment and were subjected to the diagnostic
test for AHS with negative results;
5. were protected from insect vectors during quarantine and transportation to the place of shipment.
Article 2.5.14.8.
When importing from countries considered infected with AHS or from AHS infected zones, Veterinary
Administrations should require:
for domestic horses
the presentation of an international veterinary certificate attesting that the animals:
1. have been exported only during seasons when the insect vectors are at a low level of activity;
2. showed no clinical sign of AHS on the day of shipment;
3. were kept in a quarantine station for a minimum period of 40 days immediately prior to shipment;
4. have been vaccinated against AHS at least 2 months prior to export and have been clearly identified
with a permanent mark; or
5. were not vaccinated and were subjected to the diagnostic test for AHS within 10 days prior to
shipment with negative results; and
6. were protected from insect vectors during quarantine and transportation to the place of shipment.
Article 2.5.14.9.
When importing from AHS free countries or zones, Veterinary Administrations should require:
for semen of domestic horses
the presentation of an international veterinary certificate attesting that the donor animals:
1. showed no clinical sign of AHS on the day of collection of the semen and for the following 40 days;
2. had not been vaccinated against AHS within 2 months of the day of collection;
3. were kept in an AHS free country or zone for at least 40 days prior to collection.
Article 2.5.14.10.
When importing from countries considered infected with AHS or from AHS infected zones, Veterinary
Administrations should require:
for semen of domestic horses
the presentation of an international veterinary certificate attesting that the donor animals:
1. were kept in a quarantine station for at least 40 days prior to collection of the semen;
2. were protected from insect vectors during quarantine;
3. showed no clinical sign of AHS on the day of collection and for the following 40 days;
4. have been vaccinated against AHS at least 2 months prior to the day of collection; or
5. were not vaccinated and were subjected to the diagnostic test for AHS at least 10 days after
collection with negative results.
Article 2.5.14.11.
When importing from AHS free countries or zones, Veterinary Administrations should require:
for embryos of domestic horses
the presentation of an international veterinary certificate attesting that:
1. the donor females:
a) have not been vaccinated against AHS within the 2 months prior to collection;
b) were kept in an AHS free country or zone for at least the 40 days prior to, and at the time of,
embryo collection;
2. the embryos were collected, processed and stored in conformity with the provisions of
Appendix 3.3.1.
Article 2.5.14.12.
When importing from countries considered infected with AHS or from AHS infected zones, Veterinary
Administrations should require:
SWINE DISEASES
CHAPTER 2.6.1.
Article 2.6.1.1.
Article 2.6.1.2.
2. were kept in the exporting country, since birth or for the 6 months prior to shipment, in an
establishment where no case of atrophic rhinitis was officially reported during the past year.
PORCINE BRUCELLOSIS
Article 2.6.2.1.
Article 2.6.2.2.
To qualify as free from porcine brucellosis, a herd of pigs shall satisfy the following requirements:
1. it is under official veterinary control;
2. it contains no animal found to be infected with porcine brucellosis during the past 3 years; all
suspected cases are subjected to laboratory investigation;
3. all cattle kept in the same establishment are officially free or free from brucellosis.
Article 2.6.2.3.
Article 2.6.2.4.
Article 2.6.2.5.
ENTEROVIRUS ENCEPHALOMYELITIS
(previously Teschen/Talfan disease)
Article 2.6.3.1.
For the purposes of this Terrestrial Code, the incubation period for enterovirus encephalomyelitis shall be
40 days.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.6.3.2.
A country may be considered free from enterovirus encephalomyelitis when it has been shown that
enterovirus encephalomyelitis has not been present for at least the past 3 years.
This period shall be 6 months after the slaughter of the last affected animal for countries in which a
stamping-out policy is practised with or without vaccination against enterovirus encephalomyelitis.
Article 2.6.3.3.
Article 2.6.3.4.
Article 2.6.3.5.
When importing from enterovirus encephalomyelitis free countries, Veterinary Administrations should
require:
for domestic pigs
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of enterovirus encephalomyelitis on the day of shipment;
2. were kept in a country free from enterovirus encephalomyelitis since birth or for at least the past
40 days.
Article 2.6.3.6.
When importing from enterovirus encephalomyelitis free countries, Veterinary Administrations should
require:
for wild pigs
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of enterovirus encephalomyelitis on the day of shipment;
2. come from a country free from enterovirus encephalomyelitis;
if the country of origin has a common border with a country considered infected with enterovirus
encephalomyelitis:
3. were kept in a quarantine station for the 40 days prior to shipment.
Article 2.6.3.7.
When importing from countries considered infected with enterovirus encephalomyelitis, Veterinary
Administrations should require:
for domestic pigs
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of enterovirus encephalomyelitis on the day of shipment;
2. were kept since birth, or for the past 40 days, in an establishment where no case of enterovirus
encephalomyelitis was officially reported during that period, and that the establishment of origin was
not situated in an enterovirus encephalomyelitis infected zone; or
3. were kept in a quarantine station for the 40 days prior to shipment;
4. have not been vaccinated against enterovirus encephalomyelitis; or
5. were vaccinated against enterovirus encephalomyelitis, not less than 30 days and not more than
one year prior to shipment (the nature of the vaccine used, whether inactivated or modified live
virus, and the virus types and strains included shall also be stated in the certificate).
Article 2.6.3.8.
When importing from countries considered infected with enterovirus encephalomyelitis, Veterinary
Administrations should require:
Article 2.6.3.9.
When importing from enterovirus encephalomyelitis free countries, Veterinary Administrations should
require:
for semen of pigs
the presentation of an international veterinary certificate attesting that the donor animals:
1. showed no clinical sign of enterovirus encephalomyelitis on the day of collection of the semen;
2. were kept in a country free from enterovirus encephalomyelitis for not less than 40 days prior to
collection.
Article 2.6.3.10.
When importing from countries considered infected with enterovirus encephalomyelitis, Veterinary
Administrations should require:
for semen of pigs
the presentation of an international veterinary certificate attesting that the donor animals:
1. showed no clinical sign of enterovirus encephalomyelitis on the day of collection of the semen;
2. were kept in the exporting country, for the 40 days prior to collection, in an establishment or artificial
insemination centre where no case of enterovirus encephalomyelitis was officially reported during that
period, and that the establishment or artificial insemination centre was not situated in an enterovirus
encephalomyelitis infected zone.
Article 2.6.3.11.
When importing from enterovirus encephalomyelitis free countries, Veterinary Administrations should
require:
for fresh meat of pigs
the presentation of an international veterinary certificate attesting that the entire consignment of meat comes
from animals:
1. which have been kept in a country free from enterovirus encephalomyelitis since birth or for at least
the past 40 days;
2. which have been slaughtered in an approved abattoir and have been subjected to ante-mortem and
post-mortem inspections for enterovirus encephalomyelitis with favourable results.
Article 2.6.3.12.
When importing from countries considered infected with enterovirus encephalomyelitis, Veterinary
Administrations should require:
for fresh meat of pigs
the presentation of an international veterinary certificate attesting that the entire consignment of meat comes
from animals:
1. which have not been kept in an enterovirus encephalomyelitis infected zone;
2. which have been slaughtered in an approved abattoir not situated in an enterovirus encephalomyelitis
infected zone and have been subjected to ante-mortem and post-mortem inspections for enterovirus
encephalomyelitis with favourable results.
Article 2.6.3.13.
When importing from countries considered infected with enterovirus encephalomyelitis, Veterinary
Administrations should require:
for meat products of pigs
the presentation of an international veterinary certificate attesting that:
1. the entire consignment of meat products comes from animals which have been slaughtered in an
approved abattoir and have been subjected to ante-mortem and post-mortem inspections for
enterovirus encephalomyelitis with favourable results;
2. the meat products have been processed to ensure the destruction of the enterovirus encephalomyelitis
virus;
3. the necessary precautions were taken after processing to avoid contact of the meat with any source
of enterovirus encephalomyelitis virus.
Article 2.6.3.14.
When importing from enterovirus encephalomyelitis free countries, Veterinary Administrations should
require:
for products of animal origin (from pigs) intended for use in animal feeding or for agricultural or
industrial use
the presentation of an international veterinary certificate attesting that these products come from animals
which have been kept in a country free from enterovirus encephalomyelitis since birth or for at least the
past 40 days.
Article 2.6.3.15.
When importing from countries considered infected with enterovirus encephalomyelitis, Veterinary
Administrations should require:
for meal and flour from blood, meat, defatted bones, hooves and claws (from pigs)
the presentation of an international veterinary certificate attesting that these products have been processed
using heat treatment to ensure the destruction of enterovirus encephalomyelitis virus.
Article 2.6.3.16.
When importing from countries considered infected with enterovirus encephalomyelitis, Veterinary
Administrations should require:
for bristles
the presentation of an international veterinary certificate attesting that these products have been processed to
ensure the destruction of enterovirus encephalomyelitis virus, in premises controlled and approved by the
Veterinary Administration of the exporting country.
TRANSMISSIBLE GASTROENTERITIS
Article 2.6.4.1.
For the purposes of this Terrestrial Code, the infective period for transmissible gastroenteritis (TGE) shall be
40 days.
Standards for diagnostic tests are described in the Terrestrial Manual.
Article 2.6.4.2.
Article 2.6.4.3.
Article 2.6.4.4.
AND EITHER
2. the donor animals have been resident for at least 40 days on an artificial insemination centre, and all the
pigs on this artificial insemination centre were free from clinical signs of TGE during the 12 months
prior to collection;
and
3. for fresh semen, the donor animals were subjected to a diagnostic test for TGE with negative results
during the 30 days prior to collection;
4. for frozen semen, the donor animals were subjected to a diagnostic test for TGE with negative
results at least 14 days after collection;
OR
5. the donor animals have been resident since birth in a country in which TGE is officially notifiable
and no clinical case has been recorded in the previous 3 years;
and in all situations:
6. the semen was collected, processed and stored in conformity with the provisions of Appendix 3.2.2.
Article 2.6.5.1.
For the purposes of this Terrestrial Code, the incubation period for swine vesicular disease (SVD) shall be
28 days.
Standards for diagnostic tests are described in the Terrestrial Manual.
Article 2.6.5.2.
A country may be considered free from SVD when it has been shown that SVD has not been present for
at least the past 2 years.
This period may be 9 months for countries in which a stamping-out policy is practised.
Article 2.6.5.3.
Article 2.6.5.4.
Veterinary Administrations of SVD free countries may prohibit importation or transit through their
territory, from countries considered infected with SVD, of the following commodities:
1. domestic and wild pigs;
2. semen of pigs;
3. fresh meat of domestic and wild pigs;
4. meat products of domestic and wild pigs which have not been processed to ensure the destruction of
the SVD virus;
5. products of animal origin (from pigs) intended for use in animal feeding or for agricultural or
industrial use which have not been processed to ensure the destruction of the SVD virus;
6. products of animal origin (from pigs) intended for pharmaceutical or surgical use which have not
been processed to ensure the destruction of the SVD virus;
7. pathological material and biological products (from pigs) which have not been processed to ensure the
destruction of the SVD virus.
Article 2.6.5.5.
When importing from SVD free countries, Veterinary Administrations should require:
for domestic pigs
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of SVD on the day of shipment;
2. were kept in an SVD free country since birth or for at least the past 6 weeks.
Article 2.6.5.6.
When importing from SVD free countries, Veterinary Administrations should require:
for wild pigs
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of SVD on the day of shipment;
2. come from an SVD free country;
if the country of origin has a common border with a country considered infected with SVD:
3. were kept in a quarantine station for the 6 weeks prior to shipment.
Article 2.6.5.7.
When importing from countries considered infected with SVD, Veterinary Administrations should require:
for domestic pigs
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of SVD on the day of shipment;
2. were kept since birth, or for the past 6 weeks, in an establishment where no case of SVD was officially
reported during that period, and that the establishment was not situated in an SVD infected zone;
3. were kept in a quarantine station for the 28 days prior to shipment and were subjected to the virus
neutralisation test for SVD with negative results during that period.
Article 2.6.5.8.
When importing from countries considered infected with SVD, Veterinary Administrations should require:
for wild pigs
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of SVD on the day of shipment;
2. were kept in a quarantine station for the 28 days prior to shipment and were subjected to the virus
neutralisation test for SVD with negative results during that period.
Article 2.6.5.9.
When importing from SVD free countries, Veterinary Administrations should require:
Article 2.6.5.10.
When importing from countries considered infected with SVD, Veterinary Administrations should require:
for semen of pigs
the presentation of an international veterinary certificate attesting that:
1. the donor animals:
a) showed no clinical sign of SVD on the day of collection of the semen and were subjected to the
virus neutralisation test for SVD with negative results;
b) were kept in the exporting country for the 28 days prior to collection, in an establishment or
artificial insemination centre where no case of SVD was officially reported during that period, and
that the establishment or artificial insemination centre was not situated in an SVD infected zone;
2. the semen was collected, processed and stored in conformity with the provisions of Appendix 3.2.2.
Article 2.6.5.11.
When importing from SVD free countries, Veterinary Administrations should require:
for fresh meat of pigs
the presentation of an international veterinary certificate attesting that the entire consignment of meat comes
from animals:
1. which have been kept in an SVD free country since birth or for at least the past 28 days;
2. which have been slaughtered in an approved abattoir and have been subjected to ante-mortem and
post-mortem inspections for SVD with favourable results.
Article 2.6.5.12.
When importing from countries considered infected with SVD, Veterinary Administrations should require:
for fresh meat of pigs
the presentation of an international veterinary certificate attesting that the entire consignment of meat comes
from animals:
1. which have not been kept in an SVD infected zone;
2. which have been slaughtered in an approved abattoir not situated in an SVD infected zone and have
been subjected to ante-mortem and post-mortem inspections for SVD with favourable results.
Article 2.6.5.13.
When importing from countries considered infected with SVD, Veterinary Administrations should require:
for meat products of pigs
the presentation of an international veterinary certificate attesting that:
1. the entire consignment of meat products comes from animals which have been slaughtered in an
approved abattoir and have been subjected to ante-mortem and post-mortem inspections for SVD
with favourable results;
2. the meat products have been processed to ensure the destruction of the SVD virus;
3. the necessary precautions were taken after processing to avoid contact of the meat with any source
of SVD virus.
Article 2.6.5.14.
When importing from SVD free countries, Veterinary Administrations should require:
for products of animal origin (from pigs) intended for use in animal feeding or for agricultural or
industrial use
the presentation of an international veterinary certificate attesting that these products come from animals
which have been kept in an SVD free country since birth or for at least the past 6 weeks.
Article 2.6.5.15.
When importing from SVD free countries, Veterinary Administrations should require:
for products of animal origin (from pigs) intended for pharmaceutical or surgical use
the presentation of an international veterinary certificate attesting that these products come from animals:
1. which have been kept in an SVD free country since birth or for at least the past 6 weeks;
2. which have been slaughtered in an approved abattoir and have been subjected to ante-mortem and
post-mortem inspections for SVD with favourable results.
Article 2.6.5.16.
When importing from countries considered infected with SVD, Veterinary Administrations should require:
for meal and flour from blood, meat, defatted bones, hooves and claws (from pigs)
the presentation of an international veterinary certificate attesting that these products have been processed to
ensure the destruction of the SVD virus.
Article 2.6.5.17.
When importing from countries considered infected with SVD, Veterinary Administrations should require:
for bristles (from pigs)
the presentation of an international veterinary certificate attesting that these products have been processed to
ensure the destruction of the SVD virus, in premises controlled and approved by the Veterinary
Administration of the exporting country.
Article 2.6.5.18.
When importing from countries considered infected with SVD, Veterinary Administrations should require:
for fertilisers of animal origin (from pigs)
the presentation of an international veterinary certificate attesting that these products:
1. do not come from an SVD infected zone; or
2. have been processed to ensure the destruction of the SVD virus.
Article 2.6.5.19.
When importing from countries considered infected with SVD, Veterinary Administrations should require:
for products of animal origin (from pigs) intended for pharmaceutical or surgical use
the presentation of an international veterinary certificate attesting that these products:
1. have been processed to ensure the destruction of the SVD virus;
2. come from animals which have not been kept in an SVD infected zone;
3. come from animals which have been slaughtered in an approved abattoir and have been subjected to
ante-mortem and post-mortem inspections for SVD with favourable results.
Article 2.6.6.1.
For the purposes of this Terrestrial Code, the infective period for African swine fever (ASF) shall be 40 days
(under study). Survivors of ASF can be carriers for life and the causative virus can be present in their
excretions.
Standards for diagnostic tests are described in the Terrestrial Manual.
Article 2.6.6.2.
A country may be considered free from ASF when it has been shown that ASF has not been present for
at least the past 3 years. Any importation of live pigs, semen, embryos/ova and animal products of pig
origin shall take place in conformity with the provisions of the Articles of this Chapter.
This period shall be 12 months for countries previously infected and in which a stamping-out policy is
practised and it has been demonstrated that the disease is absent from the domestic or wild pig
population.
Article 2.6.6.3.
A zone of a country may be considered free from ASF when the disease is notifiable in the whole country
and when no clinical, serological or epidemiological evidence of ASF has been found in the zone during
the past 3 years in domestic or wild pigs.
This period shall be 12 months for a zone previously infected, in which a stamping-out policy is practised
and it has been demonstrated that the disease is absent from any domestic or wild pig population.
The free zone must be clearly delineated and the animal health regulations to prevent the movement of
domestic or wild pigs into the free zone from an infected country or infected zone must be published and
rigorously implemented, with notification to the OIE in conformity with Article 1.1.2.4. of Section 1.1. of
this Terrestrial Code. Regular inspection and supervision of movement should be made of pigs in the free
zone to ensure freedom from ASF.
Article 2.6.6.4.
A zone shall be considered as infected with ASF for 3 years after the last outbreak. This period shall be
12 months for zones in which a stamping-out policy has been practised and it has been demonstrated that
the disease is absent from any domestic or wild pig population.
The boundary between the infected zone and the free zone or free country shall not be limited by national
frontiers.
Article 2.6.6.5.
Veterinary Administrations of countries should consider whether there is a risk regarding ASF in accepting
importation or transit through their territory, from other countries, of the following commodities:
1. domestic and wild pigs, particularly of the Sus, Potamochoerus, Phacochoerus and Hylochoerus genera;
2. semen of domestic and wild pigs;
3. embryos/ova of domestic and wild pigs;
4. fresh meat of domestic and wild pigs;
5. meat products of domestic and wild pigs which have not been processed to ensure the destruction of
the ASF virus;
6. products of animal origin (from pigs) intended for use in animal feeding or for agricultural or
industrial use which have not been processed to ensure the destruction of the ASF virus;
7. products of animal origin (from pigs) intended for pharmaceutical or surgical use which have not
been processed to ensure the destruction of the ASF virus;
8. pathological material and biological products (from pigs) which have not been processed to ensure the
destruction of the ASF virus.
Article 2.6.6.6.
When importing from ASF free countries or zones, Veterinary Administrations should require:
for domestic pigs
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of ASF on the day of shipment;
2. were kept in an ASF free country or zone since birth.
Article 2.6.6.7.
When importing from ASF free countries or zones, Veterinary Administrations should require:
for wild pigs
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of ASF on the day of shipment;
2. come from an ASF free country or zone;
if the country of origin has a common border with a country or zone considered infected with ASF:
3. were kept in a quarantine station for the 40 days prior to shipment;
4. were subjected to diagnostic tests for ASF with negative results.
Article 2.6.6.8.
When importing from countries considered infected with ASF, Veterinary Administrations should require:
for domestic pigs
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of ASF on the day of shipment;
2. were kept since birth, or for the past 40 days, in an establishment where no case of ASF was officially
reported during that period, that the establishment was situated in an ASF free zone, and that the
animals which were introduced into that establishment did not originate from a country or zone
infected with ASF;
3. were subjected to diagnostic tests for ASF with negative results.
Article 2.6.6.9.
When importing from countries considered infected with ASF, Veterinary Administrations should require:
for wild pigs
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of ASF on the day of shipment;
2. were kept for the 40 days prior to shipment in a quarantine station, where no case of ASF was officially
reported during that period, that the quarantine station was situated in an ASF free zone, and that the
animals which were introduced into that zone originated only from ASF free countries or zones;
3. were subjected to diagnostic tests for ASF with negative results.
Article 2.6.6.10.
When importing from ASF free zones, Veterinary Administrations should require:
for semen, embryos or ova of pigs
the presentation of an international veterinary certificate attesting that:
1. the donor animals:
a) showed no clinical sign of ASF on the day of collection of the semen or of the embryos/ova;
b) were kept in an ASF free country or zone for at least the 40 days prior to collection, and
originated only from ASF free countries or zones;
2. the semen, embryos or ova were collected, processed and stored in conformity with the provisions
of Appendix 3.2.2. and Appendix 3.3.1., respectively.
Article 2.6.6.11.
When importing from countries considered infected with ASF, Veterinary Administrations should require:
for semen of pigs
the presentation of an international veterinary certificate attesting that:
1. the donor animals:
a) showed no clinical sign of ASF on the day of collection of the semen;
b) were kept in the exporting country for the 40 days prior to collection, in an establishment or
artificial insemination centre where no case of ASF was officially reported during that period, and
that the establishment or artificial insemination centre was situated in an ASF free zone, and that the
animals did not originate from a zone infected with ASF;
c) were subjected to diagnostic tests for ASF with negative results;
2. the semen was collected, processed and stored in conformity with the provisions of Appendix 3.2.2.
Article 2.6.6.12.
When importing from ASF free zones, Veterinary Administrations should require:
for fresh meat of pigs
the presentation of an international veterinary certificate attesting that the entire consignment of meat comes
from animals:
1. which have been kept in an ASF free country or zone since birth;
2. which have been slaughtered in an approved abattoir situated in an ASF free country or zone and
which only receives animals from an ASF free country or zone;
3. which have been subjected to ante-mortem and post-mortem inspections for ASF with favourable
results.
Article 2.6.6.13.
When importing from ASF free zones, Veterinary Administrations should require:
for meat products of pigs
the presentation of an international veterinary certificate attesting that these products:
1. have been processed from meat complying with the provisions referred to in Article 2.6.6.12.;
2. have been processed in meat processing plants situated in an ASF free country or zone, and in which
only meat of animals from an ASF free country or zone is processed.
Article 2.6.6.14.
When importing from countries considered infected with ASF, Veterinary Administrations should require:
for meat products of pigs
the presentation of an international veterinary certificate attesting that:
1. the entire consignment of meat products comes from animals which have been slaughtered in an
approved abattoir and have been subjected to ante-mortem and post-mortem inspections for ASF with
favourable results;
2. the meat products have been processed to ensure the destruction of the ASF virus;
3. the necessary precautions were taken after processing to avoid contact of the meat with any source
of ASF virus.
Article 2.6.6.15.
When importing from ASF free zones, Veterinary Administrations should require:
for products of animal origin (from pigs) intended for use in animal feeding or for agricultural or
industrial use
the presentation of an international veterinary certificate attesting that these products come from animals:
1. which have been kept in an ASF free country since birth;
2. which have been slaughtered in an approved abattoir situated in an ASF free country or zone and
which only receives animals from an ASF free country or zone;
3. which have been subjected to ante-mortem and post-mortem inspections for ASF with favourable
results.
Article 2.6.6.16.
When importing from ASF free zones, Veterinary Administrations should require:
for products of animal origin (from pigs) intended for pharmaceutical or surgical use
the presentation of an international veterinary certificate attesting that these products come from animals:
1. which have been kept in an ASF free country since birth;
2. which have been slaughtered in an approved abattoir situated in an ASF free country or zone and
which only receives animals from an ASF free country or zone;
3. which have been subjected to ante-mortem and post-mortem inspections for ASF with favourable
results.
Article 2.6.6.17.
When importing from countries considered infected with ASF, Veterinary Administrations should require:
for meal and flour from blood, meat, defatted bones, hooves and claws (from pigs)
the presentation of an international veterinary certificate attesting that these products have been processed to
ensure the destruction of the ASF virus in approved plants, and that the necessary precautions were taken
after processing to avoid contact of the product with any source of ASF virus.
Article 2.6.6.18.
When importing from countries considered infected with ASF, Veterinary Administrations should require:
for bristles (from pigs)
the presentation of an international veterinary certificate attesting that these products have been processed to
ensure the destruction of the ASF virus in premises controlled and approved by the Veterinary
Administration of the exporting country, and that the necessary precautions were taken after processing to
avoid contact of the products with any source of ASF virus.
Article 2.6.6.19.
When importing from countries considered infected with ASF, Veterinary Administrations should require:
for products of animal origin (from pigs) intended for pharmaceutical or surgical use
the presentation of an international veterinary certificate attesting that:
1. these products:
a) have been processed to ensure the destruction of the ASF virus; or
b) come from animals which have not been kept in a country or zone infected with ASF;
c) come from animals which have been slaughtered in an approved abattoir situated in an ASF free
zone and have been subjected to ante-mortem and post-mortem inspections for ASF with
favourable results; and
2. the necessary precautions were taken after processing to avoid contact of the products with any
source of ASF virus.
Article 2.6.7.1.
The pig is the only natural host for classical swine fever (CSF) virus. The definition of pigs includes all
varieties of Sus scrofa, both domestic breeds and wild boar. A distinction is made between farmed and
permanently captive pigs, and free-living pigs. Farmed and permanently captive pigs of any breed will
hereafter be referred to as domestic pigs. Free-living pigs of any breed will hereafter be referred to as wild
pigs. Extensively kept pigs may fall into either of these categories or may alternate between the two.
Pigs exposed to CSF virus prenatally may be persistently infected throughout life and may have an
incubation period of several months before showing signs of disease. Pigs exposed postnatally have an
incubation period of 7-10 days, and are usually infective between post-infection days 5 and 14, but up to
3 months in cases of chronic infections.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.6.7.2.
The CSF status of a country or zone can only be determined after considering the following criteria both
in domestic and wild pigs:
1. a risk assessment has been conducted, identifying all potential factors for CSF occurrence and their
historic perspective;
2. CSF should be notifiable in the whole country and all clinical signs suggestive of CSF should be
subjected to field and/or laboratory investigations;
3. an on-going awareness programme should be in place to encourage reporting of all cases suggestive
of CSF;
4. the Veterinary Administration should have current knowledge of, and authority over, all establishments
containing pigs in the whole country;
5. the Veterinary Administration should have current knowledge about the population and habitat of
wild pigs in the whole country.
Article 2.6.7.3.
Article 2.6.7.4.
A country or zone may be considered free from the disease in domestic and wild pigs after
conducting a risk assessment as referred to in Article 2.6.7.2. but without formally applying a specific
surveillance programme (historical freedom) if the country or zone complies with the provisions of
Appendix 3.8.8.
A country or zone which does not meet the conditions of point 1 above may be considered free from
CSF in domestic and wild pigs after conducting a risk assessment as referred to in Article 2.6.7.2. and
surveillance in accordance with Appendix 3.8.8., and when:
a) it is a notifiable disease;
AND EITHER
b) where a stamping-out policy without vaccination has been practised for CSF control, no outbreak
has been observed in domestic pigs for at least 6 months; or
c) where a vaccination strategy has been adopted, with or without a stamping-out policy, vaccination
against CSF has been banned in all domestic pigs in the country or zone for at least one year,
unless there are validated means of distinguishing between vaccinated and infected pigs; if
vaccination has occurred in the past 5 years, surveillance in accordance with Appendix 3.8.8. has
been in place for at least 6 months to demonstrate absence of infection within the population of
domestic pigs 6 months to one year old, and no outbreak has been observed in domestic pigs for
at least 12 months;
AND
d) CSF infection is not known to occur in the wild pig population and surveillance of wild pigs
indicates that there is no residual infection.
Article 2.6.7.5.
Country or zone free of CSF in domestic pigs but with infection in the wild pig population
Requirements in point 2) of Article 2.6.7.4., as relevant, are complied with, but CSF infection is known to
occur in wild pigs. Additional conditions for the free status are that in the country or zone:
1. a programme for the management of CSF in wild pigs is in place, and CSF wild pig control areas are
delineated around every CSF case reported in wild pigs, taking into account the measures in place to
manage the disease in the wild pig population, the presence of natural boundaries, the ecology of the
wild pig population, and an assessment of the risk of disease spread;
2. biosecurity measures are applied to prevent transmission from wild pigs to domestic pigs;
3. surveillance in accordance with Appendix 3.8.8. is carried out in the domestic pig population, with
negative results.
Article 2.6.7.6.
Should a CSF outbreak occur in an establishment of a free country or zone (free in domestic and wild pigs,
or free in domestic pigs only), the status of the country or zone may be restored at least 30 days after
completion of a stamping-out policy which should include the following measures:
1. a CSF domestic pig control area (including an inner protection area of at least 3-kilometre radius and
an outer surveillance area of at least 10-kilometre radius) should be delineated around the outbreak,
taking into account the control measures applied, the presence of natural and administrative
boundaries, and an assessment of the risk of disease spread;
2. all the pigs have been killed and their carcasses destroyed, and disinfection has been applied within the
establishment;
3. in the protection area around a CSF outbreak:
a) a risk assessment should be carried out to determine the likelihood of CSF infection in
neighbouring establishments; when a significant risk is indicated, a stamping-out policy of all
domestic pigs within a radius of at least 0.5 kilometre may be applied;
b) an immediate clinical examination of all pigs in all pig establishments situated within the
protection area has been carried out;
4. in the surveillance area around a CSF outbreak, all sick pigs should be subjected to laboratory tests for
CSF;
5. surveillance in accordance with Appendix 3.8.8. has been carried out in all pig establishments that have
been directly or indirectly in contact with the infected establishment and in all pig establishments located
within the CSF domestic pig control area, demonstrating that these establishments are not infected;
6. measures aimed at preventing any virus spread by live pigs, pig semen and pig embryos,
contaminated material, vehicles, etc. have been implemented.
If emergency vaccination has been practised within the CSF domestic pig control area, recovery of the
free status can not occur before all the vaccinated pigs have been slaughtered, unless there are validated
means of distinguishing between vaccinated and infected pigs.
Article 2.6.7.7.
A country or zone may be considered free from CSF in wild pigs when:
1. the domestic pig population in the country or zone is free from CSF infection;
2. surveillance in accordance with Appendix 3.8.8. has been in place to determine the CSF status of the
wild pig population in the country, and in the country or zone:
a) there has been no clinical, nor virological evidence of CSF in wild pigs during the past
12 months;
b) no seropositive wild pigs have been detected in the age class 6-12 months during the past
12 months;
3. there has been no vaccination in wild pigs for the past 12 months;
4. the feeding of swill to wild pigs is forbidden, unless the swill has been treated to destroy any CSF
virus that may be present in conformity with one of the procedures referred to in Article 3.6.4.1.;
5. imported wild pigs comply with the relevant requirements set forth in the present chapter.
A zoning approach can only be adopted if there is a wild pig population that is isolated from other wild
pigs.
Article 2.6.7.8.
When importing from countries or zones free of CSF in domestic and wild pigs, Veterinary
Administrations should require:
for domestic pigs
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of CSF on the day of shipment;
2. were kept in a country or zone free of CSF in domestic and wild pigs since birth or for at least the
past 3 months;
3. have not been vaccinated against CSF, nor are they the progeny of vaccinated sows, unless there are
validated means of distinguishing between vaccinated and infected pigs.
Article 2.6.7.9.
When importing from countries or zones free of CSF in domestic pigs but with infection in the wild pig
population, Veterinary Administrations should require:
for domestic pigs
the presentation of an international veterinary certificate attesting that the animals:
1. were kept in a country or zone free of CSF in domestic pigs since birth or for at least the past
3 months;
2. have not been vaccinated against CSF, nor are they the progeny of vaccinated sows, unless there are
validated means of distinguishing between vaccinated and infected pigs;
3. come from an establishment which is not located in a CSF wild pig control area as defined in
Article 2.6.7.5., and has undergone surveillance to verify absence of CSF in accordance with
Appendix 3.8.8.;
4. have had no contact with pigs introduced into the establishment during the past 40 days;
5. showed no clinical sign of CSF on the day of shipment.
Article 2.6.7.10.
When importing from countries or zones with CSF infection in domestic pigs, Veterinary Administrations
should require:
for domestic pigs
the presentation of an international veterinary certificate attesting that the animals:
1. have not been vaccinated against CSF nor are they the progeny of vaccinated sows, unless there are
validated means of distinguishing between vaccinated and infected pigs;
2. were kept since birth, or for the past 3 months, in an establishment not situated in a CSF domestic or
wild pig control area as defined in Article 2.6.7.5. and in Article 2.6.7.6.;
3. were isolated in a quarantine station for at least 40 days;
4. were subjected during that period of quarantine to a virological test, and a serological test performed
at least 21 days after entry into the quarantine station, with negative results;
Article 2.6.7.11.
When importing from countries or zones free of CSF in domestic and wild pigs, Veterinary
Administrations should require:
for wild pigs
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of CSF on the day of shipment;
2. have been captured in a country or zone free from CSF in domestic and wild pigs;
3. have not been vaccinated against CSF, unless there are validated means of distinguishing between
vaccinated and infected pigs;
and, if the zone where the animal has been captured is adjacent to a zone with infection in wild pigs:
4. were kept in a quarantine station for 40 days prior to shipment, and were subjected to a virological
test, and a serological test performed at least 21 days after entry into the quarantine station, with
negative results.
Article 2.6.7.12.
When importing from countries or zones free of CSF in domestic and wild pigs, Veterinary
Administrations should require:
for semen of domestic pigs
the presentation of an international veterinary certificate attesting that:
1. the donor animals:
a) were kept in a country or zone free of CSF in domestic and wild pigs since birth or for at least
the past 3 months;
b) showed no clinical sign of CSF on the day of collection of the semen;
2. the semen was collected, processed and stored in conformity with the provisions of Appendix 3.2.2.
Article 2.6.7.13.
When importing from countries or zones free of CSF in domestic pigs but with infection in the wild pig
population, Veterinary Administrations should require:
for semen of domestic pigs
the presentation of an international veterinary certificate attesting that:
1. the donor animals:
a) have been kept in an artificial insemination centre which is not located in a CSF wild pig control
area and is regularly monitored to verify absence of CSF in accordance with Appendix 3.8.8.;
b) were isolated in the artificial insemination centre for at least 40 days prior to collection;
c) showed no clinical sign of CSF on the day of collection of the semen and for the following
40 days;
2. the semen was collected, processed and stored in conformity with the provisions of Appendix 3.2.2.
Article 2.6.7.14.
When importing from countries or zones considered infected with CSF in domestic pigs, Veterinary
Administrations should require:
for semen of domestic pigs
the presentation of an international veterinary certificate attesting that:
1. the donor animals:
a) showed no clinical sign of CSF on the day of collection of the semen and for the following
3 months;
b) have not been vaccinated against CSF, and were subjected to a serological test performed at
least 21 days after collection, with negative results;
2. the semen was collected, processed and stored in conformity with the provisions of Appendix 3.2.2.
Article 2.6.7.15.
When importing from countries or zones free of CSF in domestic and wild pigs, Veterinary
Administrations should require:
for in vivo derived embryos of pigs
the presentation of an international veterinary certificate attesting that:
1. the donor females showed no clinical sign of CSF on the day of collection of the embryos;
2. the embryos were collected, processed and stored in conformity with the provisions of
Appendix 3.3.1.
Article 2.6.7.16.
When importing from countries or zones free of CSF in domestic pigs but with infection in the wild pig
population, Veterinary Administrations should require:
for in vivo derived embryos of pigs
the presentation of an international veterinary certificate attesting that:
1. the donor females:
a) were kept for at least 40 days prior to collection in an establishment which is not located in a CSF
domestic or wild pig control area and is regularly monitored to verify absence of CSF in
accordance with Appendix 3.8.8.;
b) showed no clinical sign of CSF on the day of collection of the embryos;
2. the embryos were collected, processed and stored in conformity with the provisions of
Appendix 3.3.1.
Article 2.6.7.17.
When importing from countries considered infected with CSF in domestic pigs, Veterinary Administrations
should require:
Article 2.6.7.18.
When importing from countries or zones free of CSF in domestic and wild pigs, Veterinary
Administrations should require:
for fresh meat of domestic pigs
the presentation of an international veterinary certificate attesting that the entire consignment of meat comes
from animals which:
1. have been kept in a country or zone free of CSF in domestic and wild pigs since birth or for at least
the past 3 months;
2. have been slaughtered in an approved abattoir, have been subjected to ante-mortem and post-mortem
inspections and have been found free of any sign suggestive of CSF.
Article 2.6.7.19.
When importing from countries or zones free of CSF in domestic pigs but with infection in the wild pig
population, Veterinary Administrations should require:
for fresh meat of domestic pigs
the presentation of an international veterinary certificate attesting that the entire consignment of meat comes
from animals which:
1. were kept in a country or zone free of CSF in domestic pigs since birth or for at least the past
3 months;
2. were kept in an establishment which was not located in a CSF wild pig control area and had undergone
surveillance to verify absence of CSF in accordance with Appendix 3.8.8.;
3. have been slaughtered in an approved abattoir not located in a CSF control area, have been subjected
to ante-mortem and post-mortem inspections and have been found free of any sign suggestive of
CSF.
Article 2.6.7.20.
When importing from countries or zones free of CSF in domestic and wild pigs, Veterinary
Administrations should require:
Article 2.6.7.21.
Article 2.6.7.22.
iv) processing only products meeting the conditions laid down in point a) above;
OR
2. have been processed in an establishment approved by the Veterinary Administration for export
purposes and regularly inspected by the Veterinary Authority so as to ensure the destruction of the
CSF virus in conformity with one of the procedures referred to in Article 3.6.4.2.
Article 2.6.7.23.
1. come from a country or zone free of CSF in domestic and wild pigs; or
2. have been processed in an establishment approved by the Veterinary Administration for export
purposes and regularly inspected by the Veterinary Authority so as to ensure the destruction of the
CSF virus.
Article 2.6.7.24.
1. come from a country or zone free of CSF in domestic and wild pigs; or
2. come from establishments situated in a country or zone free of CSF in domestic pigs but with
infection in wild pigs, but not located in a CSF control area; or
3. have been processed in an establishment approved by the Veterinary Administration for export
purposes and regularly inspected by the Veterinary Authority so as to ensure the destruction of the
CSF virus.
AVIAN DISEASES
CHAPTER 2.7.1.
Article 2.7.1.1.
For the purposes of this Terrestrial Code, the incubation period for infectious bursal disease shall be 7 days.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.7.1.2.
Article 2.7.1.3.
When importing from countries considered infected with infectious bursal disease, Veterinary
Administrations of importing countries should require:
for day-old birds
the presentation of an international veterinary certificate attesting that the day-old birds:
1. come from establishments which are regularly inspected by the Veterinary Authority and from
hatcheries which comply with the standards referred to in Appendix 3.4.1.;
2. have not been vaccinated against infectious bursal disease; or
3. were vaccinated against infectious bursal disease (the nature of the vaccine used and the date of
vaccination shall also be stated in the certificate);
Article 2.7.1.4.
MAREK'S DISEASE
Article 2.7.2.1.
For the purposes of this Terrestrial Code, the incubation period for Marek's disease (MD) shall be 4 months.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.7.2.2.
Article 2.7.2.3.
Article 2.7.2.4.
3. come from establishments in which vaccination against MD is practised (the nature of the vaccine used
and the date of vaccination shall also be stated in the certificate);
4. were shipped in clean and unused packages.
Article 2.7.2.5.
Article 2.7.2.6.
AVIAN MYCOPLASMOSIS
(Mycoplasma gallisepticum)
Article 2.7.3.1.
Article 2.7.3.2.
To qualify as free from avian mycoplasmosis, an establishment shall satisfy the following requirements:
1. it is under official veterinary control;
2. it contains no bird which has been vaccinated against avian mycoplasmosis;
3. 5% of the birds, with a maximum of 100 birds of different age groups present in the establishment, are
subjected to the serum-agglutination test with negative results at the age of 10, 18 and 26 weeks, and
thereafter at 4-week intervals (the results of at least the last two tests carried out on adult birds
should be negative);
4. all birds introduced into the flocks come from an establishment free from avian mycoplasmosis.
Article 2.7.3.3.
Article 2.7.3.4.
Article 2.7.3.5.
AVIAN CHLAMYDIOSIS
Article 2.7.4.1.
Article 2.7.4.2.
Veterinary Administrations of countries free from avian chlamydiosis may prohibit importation or transit
through their territory, from countries considered infected with avian chlamydiosis, of birds of the
Psittacidae family.
Article 2.7.4.3.
Article 2.7.5.1.
Article 2.7.5.2.
Article 2.7.5.3.
Article 2.7.5.4.
Article 2.7.6.1.
For the purposes of this Terrestrial Code, the incubation period for avian infectious bronchitis shall be
50 days.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.7.6.2.
Article 2.7.6.3.
Article 2.7.6.4.
Article 2.7.7.1.
For the purposes of this Terrestrial Code, the incubation period for avian infectious laryngotracheitis (ILT)
shall be 14 days (chronic carriers occur).
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.7.7.2.
Article 2.7.7.3.
Article 2.7.7.4.
AVIAN TUBERCULOSIS
Article 2.7.8.1.
Article 2.7.8.2.
Article 2.7.8.3.
Article 2.7.8.4.
Article 2.7.8.5.
Article 2.7.9.1.
For the purposes of this Terrestrial Code, the incubation period for duck virus hepatitis (DVH) shall be
7 days.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.7.9.2.
Article 2.7.9.3.
Article 2.7.9.4.
Article 2.7.10.1.
For the purposes of this Terrestrial Code, the incubation period for duck virus enteritis (DVE) shall be 7 days
(chronic carriers occur).
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.7.10.2.
Article 2.7.10.3.
Article 2.7.10.4.
FOWL CHOLERA
Article 2.7.11.1.
For the purposes of this Terrestrial Code, the incubation period for fowl cholera (FC) shall be 14 days
(chronic carriers occur).
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.7.11.2.
Article 2.7.11.3.
Article 2.7.11.4.
AVIAN INFLUENZA
Article 2.7.12.1.
1. For the purposes of this Terrestrial Code, avian influenza in its notifiable form (NAI) is defined as an
infection of poultry caused by any influenza A virus of the H5 or H7 subtypes or by any AI virus
with an intravenous pathogenicity index (IVPI) greater than 1.2 (or as an alternative at least 75%
mortality) as described below. NAI viruses can be divided into highly pathogenic notifiable avian
influenza (HPNAI) and low pathogenicity notifiable avian influenza (LPNAI):
a) HPNAI viruses have an IVPI in 6-week-old chickens greater than 1.2 or, as an alternative, cause
at least 75% mortality in 4-to 8-week-old chickens infected intravenously. H5 and H7 viruses
which do not have an IVPI of greater than 1.2 or cause less than 75% mortality in an
intravenous lethality test should be sequenced to determine whether multiple basic amino acids
are present at the cleavage site of the haemagglutinin molecule (HA0); if the amino acid motif is
similar to that observed for other HPNAI isolates, the isolate being tested should be considered
as HPNAI;
b) LPNAI are all influenza A viruses of H5 and H7 subtype that are not HPNAI viruses.
2. Poultry is defined as ‘all birds reared or kept in captivity for the production of meat or eggs for
consumption, for the production of other commercial products, for restocking supplies of game, or
for breeding these categories of birds’.
3. For the purposes of international trade, this Chapter deals not only with the occurrence of clinical
signs caused by NAI virus, but also with the presence of infection with NAI virus in the absence of
clinical signs.
a) HPNAI virus has been isolated and identified as such or viral RNA specific for HPNAI has
been detected in poultry or a product derived from poultry; or
b) LPNAI virus has been isolated and identified as such or viral RNA specific for LPNAI has
been detected in poultry or a product derived from poultry; or
c) antibodies to H5 or H7 subtype of NAI virus that are not a consequence of vaccination have
been detected in poultry. In the case of isolated serological positive results, NAI infection may
be ruled out on the basis of a thorough epidemiological investigation that does not demonstrate
further evidence of NAI infection.
For the purposes of the Terrestrial Code, ‘NAI free establishment’ means an establishment in which the
poultry have shown no evidence of NAI infection, based on surveillance in accordance with
Appendix 3.8.9.
For the purposes of the Terrestrial Code, the incubation period for NAI shall be 21 days.
Standards for diagnostic tests, including pathogenicity testing, are described in the Terrestrial Manual. Any
vaccine used should comply with the standards described in the Terrestrial Manual.
Article 2.7.12.2.
The NAI status of a country, a zone or a compartment can be determined on the basis of the following
criteria:
1. the outcome of a risk assessment identifying all potential factors for NAI occurrence and their historic
perspective;
2. NAI is notifiable in the whole country, an on-going NAI awareness programme is in place, and all
notified suspect occurrences of NAI are subjected to field and, where applicable, laboratory
investigations;
3. appropriate surveillance is in place to demonstrate the presence of infection in the absence of clinical
signs in poultry, and the risk posed by birds other than poultry; this may be achieved through an
NAI surveillance programme in accordance with Appendix 3.8.9.
Article 2.7.12.3.
A country, zone or compartment may be considered free from NAI when it has been shown that neither
HPNAI nor LPNAI infection has been present in the country, zone or compartment for the past 12
months, based on surveillance in accordance with Appendix 3.8.9. The surveillance may need to be
adapted to parts of the country or existing zones or compartments depending on historical or geographical
factors, industry structure, population data, or proximity to recent outbreaks.
If infection has occurred in a previously free country, zone or compartment, free status can be regained:
1. In the case of HPNAI infections, 3 months after a stamping-out policy (including disinfection of all
affected establishments) is applied, providing that surveillance in accordance with Appendix 3.8.9. has
been carried out during that three-month period.
2. In the case of LPNAI infections, poultry may be kept for slaughter for human consumption subject
to specified conditions or a stamping-out policy applied; in either case, 3 months after the disinfection of
all affected establishments, providing that surveillance in accordance with Appendix 3.8.9. has been
carried out during that three-month period.
Article 2.7.12.4.
A country, zone or compartment may be considered free from HPNAI when it has been shown that
HPNAI infection has not been present in the country, zone or compartment for the past 12 months,
although its LPNAI status may be unknown, when, based on surveillance in accordance with
Appendix 3.8.9., it does not meet the criteria for freedom from NAI but any NAI virus detected has not
been identified as HPNAI virus. The surveillance may need to be adapted to parts of the country or zones
or compartments depending on historical or geographical factors, industry structure, population data, or
proximity to recent outbreaks.
If infection has occurred in a previously free country, zone or compartment, free status can be regained
3 months after a stamping-out policy (including disinfection of all affected establishments) is applied, providing
that surveillance in accordance with Appendix 3.8.9. has been carried out during that three-month period.
Article 2.7.12.5.
When importing from an NAI free country, zone or compartment, Veterinary Administrations should require:
Article 2.7.12.6.
Regardless of the NAI status of the country, zone or compartment of origin, Veterinary Administrations
should require:
for live birds other than poultry
the presentation of an international veterinary certificate attesting that the birds:
1. showed no clinical sign of infection with a virus which would be considered NAI in poultry on the
day of shipment;
2. were kept in isolation approved by the Veterinary Services since they were hatched or for the 21 days
prior to shipment and showed no clinical sign of infection with a virus which would be considered
NAI in poultry during the isolation period;
3. were subjected to a diagnostic test 7 to 14 days prior to shipment to demonstrate freedom from
infection with a virus which would be considered NAI in poultry;
4. are transported in new containers.
Article 2.7.12.7.
When importing from an NAI free country, zone or compartment, Veterinary Administrations should require:
for day-old live poultry
the presentation of an international veterinary certificate attesting that the poultry:
1. were kept in an NAI free country, zone or compartment since they were hatched;
2. were derived from parent flocks which had been kept in an NAI free country, zone or compartment for
21 days prior to and at the time of the collection of the eggs.
Information concerning the vaccination status of the poultry and the parent flocks (including the dates of
vaccination and the vaccine used) should be included in the veterinary certificate.
Article 2.7.12.8.
When importing from an HPNAI free country, zone or compartment, Veterinary Administrations should
require:
for day-old live poultry
the presentation of an international veterinary certificate attesting that the poultry:
1. were kept in an HPNAI free country, zone or compartment since they were hatched;
2. were derived from parent flocks which had been kept in an NAI free establishment for 21 days prior
to and at the time of the collection of the eggs;
3. are transported in new containers.
Information concerning the vaccination status of the poultry and the parent flocks (including the dates of
vaccination and the vaccine used) should be included in the veterinary certificate.
Article 2.7.12.9.
When importing from an NAI free country, zone or compartment, Veterinary Administrations should require:
for hatching eggs
the presentation of an international veterinary certificate attesting that the eggs:
1. came from an NAI free country, zone or compartment;
2. were derived from parent flocks which had been kept in an NAI free country, zone or compartment for
21 days prior to and at the time of the collection of the eggs.
Information concerning the vaccination status of the parent flocks (including the dates of vaccination and
the vaccine used) should be included in the veterinary certificate.
Article 2.7.12.10.
When importing from an HPNAI free country, zone or compartment, Veterinary Administrations should
require:
for hatching eggs
the presentation of an international veterinary certificate attesting that the eggs:
1. came from an HPNAI free country, zone or compartment;
2. were derived from parent flocks which had been kept in an NAI free establishment for 21 days prior
to and at the time of the collection of the eggs;
3. are transported in new packing material.
Information concerning the vaccination status of the parent flocks (including the dates of vaccination and
the vaccine used) should be included in the veterinary certificate.
Article 2.7.12.11.
When importing from an NAI free country, zone or compartment, Veterinary Administrations should require:
for eggs for human consumption
the presentation of an international veterinary certificate attesting that the eggs come from an NAI free
country, zone or compartment.
Article 2.7.12.12.
When importing from an HPNAI free country, zone or compartment, Veterinary Administrations should
require:
Article 2.7.12.13.
When importing from an NAI free country, zone or compartment, Veterinary Administrations should require:
for egg products
the presentation of an international veterinary certificate attesting that the egg products come from, and were
processed in, an NAI free country, zone or compartment.
Article 2.7.12.14.
Regardless of the NAI status of the country, zone or compartment of origin, Veterinary Administrations
should require:
for egg products
the presentation of an international veterinary certificate attesting that the egg products:
1. are derived from eggs which meet the requirements of Articles 2.7.12.9., 2.7.12.10., 2.7.12.11. or
2.7.12.12.; or
2. were processed to ensure the destruction of NAI virus (under study), and the necessary precautions
were taken after processing to avoid contact of the commodity with any source of NAI virus.
Article 2.7.12.15.
When importing from an NAI free country, zone or compartment, Veterinary Administrations should require:
for poultry semen
the presentation of an international veterinary certificate attesting that the donor poultry:
1. showed no clinical sign of NAI on the day of semen collection;
2. were kept in an NAI free country, zone or compartment for the 21 days prior to and at the time of
semen collection.
Article 2.7.12.16.
When importing from an HPNAI free country, zone or compartment, Veterinary Administrations should
require:
for poultry semen
the presentation of an international veterinary certificate attesting that the donor poultry:
1. came from an HPNAI free country, zone or compartment;
2. were kept in an NAI free establishment for 21 days prior to and at the time of semen collection.
Information concerning the vaccination status of the donor flocks (including the dates of vaccination and
the vaccine used) should be included in the veterinary certificate.
Article 2.7.12.17.
Regardless of the NAI status of the country, zone or compartment of origin, Veterinary Administrations
should require:
for semen of birds other than poultry
the presentation of an international veterinary certificate attesting that the donor birds:
1. were kept in isolation approved by the Veterinary Services for the 21 days prior to semen collection;
2. showed no clinical sign of infection with a virus which would be considered NAI in poultry during
the isolation period;
3. were tested between 7 and 14 days prior to semen collection and shown to be free of NAI infection.
Article 2.7.12.18.
When importing from an NAI free country, zone or compartment, Veterinary Administrations should require:
for fresh meat of poultry
the presentation of an international veterinary certificate attesting that the entire consignment of fresh meat
comes from birds:
1. which have been kept in an NAI free country, zone or compartment since they were hatched or for the
past 21 days;
2. which have been slaughtered in an approved abattoir and have been subjected to ante-mortem and
post-mortem inspections for NAI with favourable results.
Article 2.7.12.19.
When importing from an HPNAI free country, zone or compartment, Veterinary Administrations should
require:
for fresh meat of poultry
the presentation of an international veterinary certificate attesting that the entire consignment of fresh meat
comes from birds:
1. which have been kept in an establishment since they were hatched or for the past 21 days and in which
there has been no evidence of NAI in the past 21 days;
2. which have been slaughtered in an approved abattoir and have been subjected to ante-mortem and
post-mortem inspections for NAI with favourable results.
Article 2.7.12.20.
Regardless of the NAI status of the country, zone or compartment of origin, Veterinary Administrations
should require:
Article 2.7.12.21.
Regardless of the NAI status of the country, zone or compartment of origin, Veterinary Administrations
should require:
for products of poultry origin intended for use in animal feeding, or for agricultural or industrial use
the presentation of an international veterinary certificate attesting that:
1. these commodities come from birds which have been kept in an NAI free country, zone or compartment
since they were hatched or for the past 21 days; or
2. these commodities have been processed to ensure the destruction of NAI virus (under study);
3. the necessary precautions were taken to avoid contact of the commodity with any source of NAI virus.
Article 2.7.12.22.
Regardless of the NAI status of the country, zone or compartment of origin, Veterinary Administrations
should require:
for feathers and down (from poultry)
the presentation of an international veterinary certificate attesting that:
1. these commodities come from birds which have been kept in an NAI free country, zone or compartment
since they were hatched or for the past 21 days; or
2. these commodities have been processed to ensure the destruction of NAI virus (under study);
3. the necessary precautions were taken to avoid contact of the commodity with any source of NAI virus.
Article 2.7.12.23.
Regardless of the NAI status of the country, zone or compartment, Veterinary Administrations should require
for the importation of:
meat or other products from birds other than poultry
the presentation of an international veterinary certificate attesting that:
1. the commodity has been processed to ensure the destruction of NAI virus (under study);
2. the necessary precautions were taken after processing to avoid contact of the commodity with any
source of NAI virus.
NEWCASTLE DISEASE
Article 2.7.13.1.
For the purposes of this Terrestrial Code, the incubation period for Newcastle disease (ND) shall be 21 days.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.7.13.2.
ND free country
A country may be considered free from ND when it has been shown that ND has not been present for at
least the past 3 years.
This period shall be 6 months after the slaughter of the last affected animal for countries in which a
stamping-out policy is practised with or without vaccination against ND.
Article 2.7.13.3.
ND infected zone
Article 2.7.13.4.
Veterinary Administrations of ND free countries may prohibit importation or transit through their
territory, from countries considered infected with ND, of the following commodities:
1. domestic and wild birds;
2. day-old birds;
3. hatching eggs;
4. semen of domestic and wild birds;
5. fresh meat of domestic and wild birds;
6. meat products of domestic and wild birds which have not been processed to ensure the destruction of
the ND virus;
7. products of animal origin (from birds) intended for use in animal feeding or for agricultural or
industrial use.
Article 2.7.13.5.
Article 2.7.13.6.
Article 2.7.13.7.
When importing from countries considered infected with ND, Veterinary Administrations should require:
for domestic birds
the presentation of an international veterinary certificate attesting that the birds:
1. showed no clinical sign of ND on the day of shipment;
2. come from an establishment which is regularly inspected by the Veterinary Authority;
3. come from an establishment free from ND and not situated in an ND infected zone; or
4. were kept in a quarantine station since they were hatched or for the 21 days prior to shipment and
were subjected to a diagnostic test for ND with negative results;
5. have not been vaccinated against ND; or
6. were vaccinated against ND using a vaccine complying with the standards described in the Terrestrial
Manual (the nature of the vaccine used and the date of vaccination shall also be stated in the
certificate).
Article 2.7.13.8.
When importing from countries considered infected with ND, Veterinary Administrations should require:
for wild birds
the presentation of an international veterinary certificate attesting that the birds:
1. showed no clinical sign of ND on the day of shipment;
2. were kept in a quarantine station since they were hatched or for at least the 21 days prior to shipment;
3. were subjected to a diagnostic test for ND with negative results before entry into quarantine.
Article 2.7.13.9.
Article 2.7.13.10.
When importing from countries considered infected with ND, Veterinary Administrations should require:
for day-old birds
the presentation of an international veterinary certificate attesting that the day-old birds:
1. come from hatcheries which are regularly inspected by the Veterinary Authority;
2. come from hatcheries free from ND and not situated in an ND infected zone;
3. have not been vaccinated against ND; or
4. were vaccinated against ND using a vaccine complying with the standards described in the Terrestrial
Manual (the nature of the vaccine used and the date of vaccination shall also be stated in the
certificate).
Article 2.7.13.11.
Article 2.7.13.12.
When importing from countries considered infected with ND, Veterinary Administrations should require:
for hatching eggs
the presentation of an international veterinary certificate attesting that the hatching eggs:
1. have been disinfected in conformity with the procedures referred to in Appendix 3.4.1.;
2. come from establishments or hatcheries which are regularly inspected by the Veterinary Authority;
3. come from establishments or hatcheries free from ND and not situated in an ND infected zone;
4. come from establishments or hatcheries in which birds were not vaccinated against ND; or
5. come from establishments or hatcheries in which birds were vaccinated against ND (the nature of the
vaccine used and the date of vaccination shall also be stated in the certificate).
Article 2.7.13.13.
Article 2.7.13.14.
When importing from countries considered infected with ND, Veterinary Administrations should require:
for semen of domestic and wild birds
the presentation of an international veterinary certificate attesting that the donor birds:
1. showed no clinical sign of ND on the day of collection of the semen;
2. had not been vaccinated using ND live virus vaccine at any time before collection;
3. were kept in the exporting country, in an establishment which was regularly inspected by the Veterinary
Authority;
4. were kept in an establishment free from ND and not situated in an ND infected zone.
Article 2.7.13.15.
Article 2.7.13.16.
When importing from countries considered infected with ND, Veterinary Administrations should require:
for fresh meat of poultry
the presentation of an international veterinary certificate attesting that the entire consignment of meat comes
from birds:
1. which have been kept in an establishment free from ND and not situated in an ND infected zone;
2. which have been slaughtered in an approved abattoir not situated in an ND infected zone and have
been subjected to ante-mortem and post-mortem inspections for ND with favourable results.
Article 2.7.13.17.
When importing from countries considered infected with ND, Veterinary Administrations should require:
1. the entire consignment of meat products comes from birds which have been slaughtered in an approved
abattoir and have been subjected to ante-mortem and post-mortem inspections for ND with
favourable results;
2. the meat products have been processed to ensure the destruction of the ND virus;
3. the necessary precautions were taken after processing to avoid contact of the meat with any source
of ND virus.
Article 2.7.13.18.
for products of animal origin (from birds) intended for use in animal feeding or for agricultural or
industrial use
the presentation of an international veterinary certificate attesting that these products come from birds which
have been kept in an ND free country since they were hatched or for at least the past 21 days.
Article 2.7.13.19.
When importing from countries considered infected with ND, Veterinary Administrations should require:
for meal and flour from meat and feather (from birds)
the presentation of an international veterinary certificate attesting that these products have been processed
using heat treatment to ensure the destruction of the ND virus.
Article 2.7.13.20.
When importing from countries considered infected with ND, Veterinary Administrations should require:
the presentation of an international veterinary certificate attesting that these products have been processed to
ensure the destruction of the ND virus.
LAGOMORPH DISEASES
CHAPTER 2.8.1.
MYXOMATOSIS
Article 2.8.1.1.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.8.1.2.
2. were kept since birth, or for the 6 months prior to shipment, in an establishment where no case of
myxomatosis was officially reported during that period.
Article 2.8.1.3.
the presentation of an international veterinary certificate attesting that the skins and fur were treated (dried
and tanned) to ensure the destruction of the myxomatosis virus.
Article 2.8.2.1.
For the purposes of this Terrestrial Code, the infective period for rabbit haemorrhagic disease (RHD) shall be
60 days.
Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.
Article 2.8.2.2.
A country may be considered free from RHD when it has been shown that the disease has not been
present for at least one year, that no vaccination has been carried out in the previous 12 months, and that
virological or serological surveys in both domestic and wild rabbits have confirmed the absence of the
disease.
This period may be reduced to 6 months after the last case has been eliminated and disinfection procedures
completed in countries adopting a stamping-out policy, and where the serological survey confirmed that the
disease had not occurred in the wild rabbits.
Article 2.8.2.3.
An establishment may be considered free from RHD when it has been shown, by serological testing, that
the disease has not been present for at least one year, and that no vaccination has been carried out in the
previous 12 months. Such establishments should be regularly inspected by the Veterinary Authority.
A previously infected establishment may be considered free when 6 months have elapsed after the last case
has been eliminated, and after:
1. a stamping-out policy has been adopted and carcasses have been disposed of by burning;
2. the rabbitry has been thoroughly disinfected and kept empty for at least 6 weeks;
3. the rabbitry is properly fenced to prevent the straying of wild lagomorphs into the rabbitry.
Article 2.8.2.4.
Veterinary Administrations of RHD free countries may prohibit importation or transit through their
territory, from countries considered infected with RHD, of live rabbits, semen, meat and non-treated
pelts.
Article 2.8.2.5.
When importing from RHD free countries, Veterinary Administrations of importing countries should require:
Article 2.8.2.6.
When importing from RHD free countries, Veterinary Administrations of importing countries should require:
for day-old rabbits destined for breeding
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of RHD on the day of shipment;
2. were born from female rabbits which had been kept in a country free from RHD for at least the past
60 days.
Article 2.8.2.7.
When importing from countries considered infected with RHD, Veterinary Administrations of importing
countries should require:
for domestic rabbits destined for breeding or pharmaceutical or surgical or agricultural or industrial use
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of RHD on the day of shipment;
AND
2. were kept in a RHD free establishment where no clinical case of RHD was found when inspected by
an Official Veterinarian immediately prior to shipment;
OR
3. were kept in an establishment where no case of RHD was reported during the 60 days prior to
shipment and no clinical case of RHD was found when inspected by an Official Veterinarian
immediately prior to shipment; and
4. were kept in an establishment where no animal has been vaccinated against RHD; and
5. were kept in an establishment where breeding rabbits (at least 10% of the animals) were subjected to
the serological test for RHD with negative results during the 60 days prior to shipment; and
6. have not been vaccinated against RHD; or
7. were vaccinated against RHD immediately before shipment (the nature of the vaccine used and the
date of vaccination shall also be stated in the certificate).
Article 2.8.2.8.
When importing from countries considered infected with RHD, Veterinary Administrations of importing
countries should require:
Article 2.8.2.9.
When importing from countries considered infected with RHD, Veterinary Administrations of importing
countries should require:
for domestic rabbits destined for immediate slaughter
the presentation of an international veterinary certificate attesting that the animals:
1. showed no clinical sign of RHD on the day of shipment;
2. were kept in an establishment where no case of RHD was reported during the 60 days prior to
shipment.
Article 2.8.2.10.
When importing from countries considered infected with RHD, Veterinary Administrations of importing
countries should require:
for semen
the presentation of an international veterinary certificate attesting that the donor animals:
1. showed no clinical sign of RHD on the day of collection of the semen;
2. were subjected to the serological test for RHD with negative results during the 30 days prior to
collection.
Article 2.8.2.11.
When importing from countries considered infected with RHD, Veterinary Administrations of importing
countries should require:
for domestic rabbit meat
the presentation of an international veterinary certificate attesting that the meat comes from animals which:
1. were kept in establishments where no case of RHD was reported during the 60 days prior to transport
to the approved abattoir;
2. were subjected to ante-mortem inspections for RHD with favourable results;
3. showed no lesions of RHD at post-mortem inspections.
Article 2.8.2.12.
When importing from RHD free countries, Veterinary Administrations of importing countries should require:
for non-treated pelts
the presentation of an international veterinary certificate attesting that the pelts come from rabbits which had
been kept in a country free from RHD for at least 60 days before slaughter.
Article 2.8.2.13.
When importing from countries considered infected with RHD, Veterinary Administrations of importing
countries should require:
for pelts
the presentation of an international veterinary certificate attesting that the pelts were subjected to a drying
treatment for at least one month and a formalin-based treatment by spraying at a 3% concentration, or by
fumigation carried out in conformity with one of the methods described in Appendix 3.4.1., not more
than 7 days prior to shipment.
BEE DISEASES
CHAPTER 2.9.1.
Article 2.9.1.1.
For the purposes of this chapter, acarapisosis, acarine disease or tracheal mite infestation is a disease of
the adult honey bee Apis mellifera L., and possibly of other Apis species (such as Apis cerana). It is caused
by the Tarsonemid mite Acarapis woodi (Rennie). The mite is an internal obligate parasite of the
respiratory system, living and reproducing mainly in the large prothoracic trachea of the bee. Early signs
of infection normally go unnoticed, and only when infection is heavy does it become apparent; this is
generally in the early spring. The infection spreads by direct contact from adult bee to adult bee, with
newly emerged bees under 10 days old being the most susceptible. The mortality rate may range from
moderate to high.
Standards for diagnostic tests are described in the Terrestrial Manual.
Article 2.9.1.2.
The acarapisosis status of a country or zone/compartment (under study) can only be determined after
considering the following criteria:
1. a risk assessment has been conducted, identifying all potential factors for acarapisosis occurrence and
their historic perspective;
2. acarapisosis should be notifiable in the whole country or zone/compartment (under study) and all
clinical signs suggestive of acarapisosis should be subjected to field and laboratory investigations;
3. an on-going awareness programme should be in place to encourage reporting of all cases suggestive
of acarapisosis;
4. the Veterinary Administration or other Competent Authority with responsibility for the health of honey
bees should have current knowledge of, and authority over, all domesticated apiaries in the whole
country.
Article 2.9.1.3.
surveillance programme if the country or zone/compartment (under study) complies with the
provisions of Appendix 3.8.1.
2. Free status as a result of an eradication programme
A country or zone/compartment (under study) which does not meet the conditions of point 1 above
may be considered free from acarapisosis after conducting a risk assessment as referred to in
Article 2.9.1.2. and when:
a) the Veterinary Administration or other Competent Authority with responsibility for the health of
honey bees has current knowledge of, and authority over, all domesticated apiaries existing in
the country or zone/compartment (under study);
b) acarapisosis is notifiable in the whole country or zone /compartment (under study), and any
clinical cases suggestive of acarapisosis are subjected to field and laboratory investigations;
c) for the 3 years following the last reported case of acarapisosis, annual surveys supervised by the
Veterinary Administration, with negative results, have been carried out on a representative sample
of apiaries in the country or zone/compartment (under study) to provide a confidence level of at
least 95% of detecting acarapisosis if at least 1% of the apiaries were infected at a within-apiary
prevalence rate of at least 5% of the hives; such surveys may be targeted towards apiaries, areas
and seasons with a higher likelihood of disease;
d) to maintain free status, an annual survey supervised by the Veterinary Administration, with
negative results, is carried out on a representative sample of apiaries in the country or
zone/compartment (under study) to indicate that there has been no new cases; such surveys may
be targeted towards areas with a higher likelihood of disease;
e) (under study) there is no self-sustaining feral population of A. mellifera or other possible host
species in the country or zone/compartment (under study);
f) the importation of the commodities listed in this Chapter into the country or zone/compartment
(under study) is carried out in conformity with the recommendations of this Chapter.
Article 2.9.1.4.
Regardless of the acarapisosis status of the exporting country, Veterinary Administrations should authorise
without restriction the import or transit through their territory of the following commodities:
1. honey bee semen and honey bee venom;
2. used equipment associated with beekeeping;
3. honey, beeswax, honey bee-collected pollen, propolis and royal jelly.
Article 2.9.1.5.
Article 2.9.1.6.
Article 2.9.2.1.
For the purposes of this Chapter, American foulbrood is a disease of the larval and pupal stages of the
honey bee Apis mellifera and other Apis spp., and occurs in most countries where such bees are kept.
Paenibacillus larvae subsp. larvae, the causative organism, is a bacterium that can produce over one billion
spores in each infected larva. The spores are very long-living and extremely resistant to heat and chemical
agents, and only the spores are capable of inducing the disease.
Combs of infected apiaries may show distinctive clinical signs which can allow the disease to be diagnosed
in the field. However, subclinical infections are common and require laboratory diagnosis.
For the purposes of this Terrestrial Code, the incubation period for American foulbrood shall be 15 days (not
including the wintering period which may vary according to country).
Article 2.9.2.2.
The American foulbrood status of a country or zone/compartment (under study) can only be determined
after considering the following criteria:
1. a risk assessment has been conducted, identifying all potential factors for American foulbrood
occurrence and their historic perspective;
2. American foulbrood should be notifiable in the whole country or zone/compartment (under study)
and all clinical signs suggestive of American foulbrood should be subjected to field and/or
laboratory investigations;
3. an on-going awareness programme should be in place to encourage reporting of all cases suggestive
of American foulbrood;
4. the Veterinary Administration or other Competent Authority with responsibility for the health of honey
bees should have current knowledge of, and authority over, all domesticated apiaries in the country.
Article 2.9.2.3.
A country or zone/compartment (under study) may be considered free from the disease after
conducting a risk assessment as referred to in Article 2.9.2.2. but without formally applying a specific
surveillance programme if the country or zone/compartment (under study) complies with the
provisions of Appendix 3.8.1.
Article 2.9.2.4.
Regardless of the American foulbrood status of the exporting country, Veterinary Administrations should
authorise without restriction the import or transit through their territory of honey bee semen and honey
bee venom.
Article 2.9.2.5.
Article 2.9.2.6.
Article 2.9.2.7.
Article 2.9.2.8.
Veterinary Administrations of importing countries officially free from American foulbrood should require:
for honey, honey bee-collected pollen, beeswax, propolis and royal jelly
the presentation of an international veterinary certificate attesting that the products:
1. were collected in a country or zone/compartment (under study) free from American foulbrood; or
2. have been processed to ensure the destruction of both bacillary and spore forms of P. larvae larvae, in
conformity with one of the procedures referred to in Appendix XXX (under study).
Article 2.9.3.1.
For the purposes of this Chapter, European foulbrood is a disease of the larval and pupal stages of the
honey bee Apis mellifera and other Apis spp., and occurs in most countries where such bees are kept. The
causative agent is the non-sporulating bacterium Melissococcus pluton. Subclinical infections are common
and require laboratory diagnosis. Infection remains enzootic because of mechanical contamination of the
honeycombs. Recurrences of disease can therefore be expected in subsequent years.
For the purposes of this Terrestrial Code, the incubation period for European foulbrood shall be 15 days (not
including the wintering period which may vary according to country).
Standards for diagnostic tests are described in the Terrestrial Manual.
Article 2.9.3.2.
The European foulbrood status of a country or zone/compartment (under study) can only be determined
after considering the following criteria:
1. a risk assessment has been conducted, identifying all potential factors for European foulbrood
occurrence and their historic perspective;
2. European foulbrood should be notifiable in the whole country or zone/compartment (under study)
and all clinical signs suggestive of European foulbrood should be subjected to field and laboratory
investigations;
3. an on-going awareness programme should be in place to encourage reporting of all cases suggestive
of European foulbrood;
4. the Veterinary Administration or other Competent Authority with responsibility for the health of honey
bees should have current knowledge of, and authority over, all apiaries in the whole country.
Article 2.9.3.3.
b) European foulbrood is notifiable in the whole country or zone/compartment (under study), and
any clinical cases suggestive of European foulbrood are subjected to field and laboratory
investigations;
c) for the 3 years following the last reported isolation of the European foulbrood agent, an annual
survey supervised by the Veterinary Administration, with negative results, have been carried out
on a representative sample of apiaries in the country or zone/compartment (under study) to
provide a confidence level of at least 95% of detecting European foulbrood if at least 1% of the
apiaries were infected at a within-apiary prevalence rate of at least 5% of the hives; such surveys
may be targeted towards areas with the last reported isolation of the European foulbrood agent;
d) to maintain free status, an annual survey supervised by the Veterinary Administration, with
negative results, is carried out on a representative sample of hives in the country or
zone/compartment (under study) to indicate that there has been no new isolations; such surveys
may be targeted towards areas with a higher likelihood of isolation;
e) (under study) there is no self-sustaining feral population of A. mellifera or other possible host
species in the country or zone/compartment (under study);
f) the importation of the commodities listed in this Chapter into the country or zone/compartment
(under study) is carried out in conformity with the recommendations of this Chapter.
Article 2.9.3.4.
Regardless of the European foulbrood status of the exporting country, Veterinary Administrations should
authorise without restriction the import or transit through their territory of honey bee semen and honey
bee venom.
Article 2.9.3.5.
Article 2.9.3.6.
Article 2.9.3.7.
Article 2.9.3.8.
Article 2.9.4.1.
For the purposes of this Chapter, varroosis is a disease of the honey bee Apis mellifera L. It is caused by
the Korea and Japan haplotypes of the mite Varroa destructor, the original hosts of which are the Korea
and Japan haplotypes of Apis cerana (under study). The mite is an ectoparasite of adults and brood of
Apis mellifera L. Early signs of infection normally go unnoticed, and only when infection is heavy does it
become apparent. The infection spreads by direct contact from adult bee to adult bee, and by the
movement of infested bees and bee brood. The mite can also act as a vector for viruses of the honey bee.
The number of parasites steadily increases with increasing brood activity and the growth of the bee
population, especially late in the season when clinical signs of infestation can first be recognised. The life
span of the mite depends on temperature and humidity but, in practice, it can be said to last from some
days to a few months.
Article 2.9.4.2.
The varroosis status of a country or zone/compartment (under study) can only be determined after
considering the following criteria:
1. a risk assessment has been conducted, identifying all potential factors for varroosis occurrence and
their historic perspective;
2. varroosis should be notifiable in the whole country or zone/compartment (under study) and all clinical
signs suggestive of varroosis should be subjected to field and laboratory investigations;
3. an on-going awareness programme should be in place to encourage reporting of all cases suggestive
of varroosis;
4. the Veterinary Administration or other Competent Authority with responsibility for the health of honey
bees should have current knowledge of, and authority over, all domesticated apiaries in the country.
Article 2.9.4.3.
A country or zone/compartment (under study) may be considered free from the disease after
conducting a risk assessment as referred to in Article 2.9.4.2. but without formally applying a specific
surveillance programme (historical freedom) if the country or zone/compartment (under study)
complies with the provisions of Appendix 3.8.1.
Article 2.9.4.4.
Regardless of the varroosis status of the exporting country, Veterinary Administrations should authorise
without restriction the import or transit through their territory of the following commodities:
1. honey bee semen, honey bee eggs and honey bee venom;
2. extracted honey and beeswax (not in the form of honeycomb).
Article 2.9.4.5.
Article 2.9.4.6.
2. have originated from queens in a quarantine station and were inspected and found free of
Varroa destructor.
Article 2.9.4.7.
2. contains no live honey bees or bee brood and has been held away from contact with live honey bees
for at least 7 days prior to shipment; or
3. has been treated to ensure the destruction of Varroa destructor, in conformity with one of the
procedures referred to in Appendix XXX (under study).
Article 2.9.4.8.
for honey-bee collected pollen, beeswax (in the form of honeycomb), comb honey and propolis
2. contain no live honey bees or bee brood and has been held away from contact with live honey bees
for at least 7 days prior to shipment; or
3. have been treated to ensure the destruction of Varroa destructor, in conformity with one of the
procedures referred to in Appendix XXX (under study).
Article 2.9.5.1.
For the purposes of this Chapter, Tropilaelaps infestation of the honey bee Apis mellifera L. is caused by
the mite Tropilaelaps clareae and T. koenigerum. The mite is an ectoparasite of brood of Apis mellifera L.,
Apis laboriosa and Apis dorsata, and cannot survive for periods of more than 7 days away from bee brood.
Early signs of infection normally go unnoticed, but the growth in the mite population is rapid leading to
high hive mortality. The infection spreads by direct contact from adult bee to adult bee, and by the
movement of infested bees and bee brood. The mite can also act as a vector for viruses of the honey bee.
Standards for diagnostic tests are described in the Terrestrial Manual.
Article 2.9.5.2.
The Tropilaelaps status of a country or zone/compartment (under study) can only be determined after
considering the following criteria:
1. a risk assessment has been conducted, identifying all potential factors for Tropilaelaps occurrence and
their historic perspective;
2. Tropilaelaps infestation should be notifiable in the whole country or zone/compartment (under study)
and all clinical signs suggestive of Tropilaelaps infestation should be subjected to field and laboratory
investigations;
3. an on-going awareness programme should be in place to encourage reporting of all cases suggestive
of Tropilaelaps infestation;
4. the Veterinary Administration or other Competent Authority with responsibility for the health of honey
bees should have current knowledge of, and authority over, all domesticated apiaries in the country.
Article 2.9.5.3.
b) Tropilaelaps infestation is notifiable in the whole country or zone/compartment (under study), and
any clinical cases suggestive of Tropilaelaps infestation are subjected to field and laboratory
investigations;
c) for the 3 years following the last reported case of Tropilaelaps infestation, an annual survey
supervised by the Veterinary Administration, with negative results, have been carried out on a
representative sample of apiaries in the country or zone/compartment (under study) to provide a
confidence level of at least 95% of detecting Tropilaelaps infestation if at least 1% of the apiaries
were infected at a within-apiary prevalence rate of at least 5% of the hives; such surveys may be
targeted towards areas with a higher likelihood of infestation;
d) to maintain free status, an annual survey supervised by the Veterinary Administration, with
negative results, is carried out on a representative sample of apiaries in the country or
zone/compartment (under study) to indicate that there has been no new cases; such surveys may
be targeted towards areas with a higher likelihood of disease;
e) (under study) there is no self-sustaining feral population of A. mellifera, A. dorsata or
A. laboriosa, or other possible host species in the country or zone/compartment (under study);
f) the importation of the commodities listed in this Chapter into the country or zone/compartment
(under study) is carried out, in conformity with the recommendations of this Chapter.
Article 2.9.5.4.
Regardless of the status of the exporting country with regard to Tropilaelaps infestation, Veterinary
Administrations should authorise without restriction the import or transit through their territory of the
following commodities:
1. honey bee semen, honey bee eggs and honey bee venom;
2. extracted honey and beeswax (not in the form of honeycomb).
Article 2.9.5.5.
Article 2.9.5.6.
Article 2.9.5.7.
Article 2.9.5.8.
OTHER DISEASES
CHAPTER 2.10.1.
ZOONOSES TRANSMISSIBLE
FROM NON-HUMAN PRIMATES
Article 2.10.1.1.
Introduction
There are about 180 different species of non-human primates belonging to 2 suborders which are split
into 12 families. The tree shrew family (previously considered as belonging to the primates) has not been
included in these recommendations.
All non-human primate species are included in Appendix I or Appendix II of the Convention on
International Trade in Endangered Species of Wild Fauna and Flora (CITES) and may be transported
internationally only if accompanied by the permits or certificates required under CITES.
Most imported non-human primates are destined for research, educational or breeding purposes.
Public health and safety are the primary issues of concern in the importation and keeping of non-human
primates. This is especially true where close contact between humans and animals, their body fluids,
faeces and tissues is likely to occur. Minimising the risk requires well-trained personnel and the following
of stringent personal hygiene standards.
The risk of carrying zoonotic pathogens is related to the taxonomic position and the region of origin of
the species concerned. It can be considered to increase from prosimians to marmosets and tamarins, then
to other New World monkeys, to Old World monkeys and apes. The risk of carrying zoonotic agents is
also greater in wild-caught non-human primates than in captive-bred animals which have been maintained
in a well-defined environment under veterinary supervision. For non-human primates taken from the
wild, usually only very limited health related information can be given by the supplier and by the
Veterinary Administration of the exporting country.
Most diseases referred to in this Chapter are not included in the OIE List, and there is, consequently, no
requirement to report them on a regular basis within the OIE animal disease reporting system. However,
the requirement to report exceptional epidemiological events remains in effect.
Standards for diagnostic tests are described in the Terrestrial Manual (under study).
Article 2.10.1.2.
General recommendations
Veterinary Administrations of exporting countries should issue international veterinary certificates only upon
presentation of valid CITES documentation.
Veterinary Administrations should make sure that the animals are individually identified by approved
methods that avoid transmission of disease (see Appendix 3.4.3.).
For reasons of public health, Veterinary Administrations of importing countries should not authorise the
import of non-human primates for the purpose of being kept as pets.
In the case of a non-human primate being imported directly from a country within the natural range of
the animal's species concerned, and where only limited health guarantees can be given, Veterinary
Administrations of importing countries should place more emphasis on quarantine procedures and less on
veterinary certification. As a matter of principle, limited health guarantees given by the supplier or the
Veterinary Administration of the country of origin should not constitute an obstacle to imports, but very
strict post import quarantine requirements should be imposed. Particularly, the quarantine should meet
the standards set in Appendix 3.5.1., and should be of sufficient length to minimise the risk of
transmission of diseases where tests are not readily available or of limited value.
Veterinary Administrations of importing countries may reduce the quarantine requirements for non-human
primates imported from premises with permanent veterinary supervision provided that the animals were
born or have been kept for at least 2 years on these premises, are individually identified and accompanied
by proper certification issued by qualified officials, and the official certification is supplemented by a
complete documentation of the clinical history of each animal and its group of origin.
In cases where it is necessary to import non-human primates which are known or suspected to be carriers
of a zoonotic disease, the import should not be restricted by any of these recommendations, provided
that the Veterinary Administration of the importing country requires the placing of the animals in an
establishment located on its territory which has been approved to receive them and which meets the
standards set in Appendix 3.5.1.
Article 2.10.1.3.
Article 2.10.1.4.
Veterinary Administrations of importing countries should require for shipments which originate from the wild
or other sources where they were not subjected to permanent veterinary supervision:
1. the presentation of the documentation referred to in Article 2.10.1.3.;
2. the immediate placement of the animals in a quarantine station meeting the standards set in
Appendix 3.5.1. for at least 12 weeks; and during this quarantine:
a) all animals to be monitored daily for signs of illness and, if necessary, be subjected to a clinical
examination;
b) all animals dying for any reason to be subjected to complete post-mortem examination at a
laboratory approved for this purpose;
c) any cause of illness or death to be determinated before the group to which the animals belong is
released from quarantine;
d) animals to be subjected to the following diagnostic tests and treatments in accordance with
Appendix 3.4.3.:
Disease/agent Animal groups Schedule Methods
Hepatitis B Gibbons and great First test during first Serological tests for
apes week; second test after anti-hepatitis B core antigen
3 to 4 weeks and for hepatitis B surface
antigen, and additional
parameters as appropriate.
Tuberculosis Marmosets and Two tests at an interval Skin test or serology. Of the
(Mycobacterium tamarins of 2 to 4 weeks skin tests, the Mantoux test is
hominis and the most reliable of all and
M. bovis) Prosimians, New At least three tests at has the advantage over others
World monkeys, intervals of 2 to in that the size of the
Old World 4 weeks reaction to the test is related
monkeys, gibbons to the severity of infection.
and great apes Skin tests in marmosets,
tamarins or small prosimians
should be performed in the
abdominal skin rather than in
the eyelid. In some species
(e.g. orang utan), skin tests
for tuberculosis are notorious
for false positive results.
Comparative tests using both
mammalian and avian PPD,
together with cultures,
radiography and ELISA may
eliminate confusion.
Other bacterial All species Daily test for 3 days Faecal culture. The fresh
pathogens within the first 5 days faeces or rectal swabs have to
(Salmonella, after arrival, and at least be cultured immediately or to
Shigella, Yersinia one or two more tests be placed immediately in the
and others as at intervals of 2 to transportation medium.
appropriate) 4 weeks
Endo- and All species At least two tests, one Testing methods and
ectoparasites of which should be at antiparasitic treatment as
the start, the other appropriate to species of
towards the end of the animal and parasitic agent.
quarantine
In addition, Veterinary Administrations of importing countries should recognize the public health importance
of other zoonoses such as measles, hepatitis A, monkey pox, Marburg disease or Ebola/Reston etc., even
though this Article does not recommend specific testing or treatment protocols for these agents during
the quarantine period. Veterinary Administrations should recognize that, if animals are infected, the
importation and spread of many such agents will be best controlled by the detection of clinical signs of
disease during the quarantine period if this is correctly implemented during a 12-week period. For some
viral zoonoses, e.g. Herpes B, current diagnostic testing is not reliable, and for others, e.g. herpes viruses
or retroviruses, which can be latent and relatively ubiquitous, producing life-long infections in some
species, the diagnosis and exclusion of such infected animals may not be possible for the purposes of
importation. Therefore, the precautions described in Article 2.10.1.7. must be strictly applied when
handling such non-human primates in order to protect human health and safety.
Article 2.10.1.5.
Certification and quarantine requirements for marmosets and tamarins from premises under
veterinary supervision
Bacterial All species Daily test for 3 days Faecal culture. (See further
pathogens within the first 5 days comments in the Table of
(Salmonella, after arrival Article 2.10.1.4.)
Shigella, Yersinia
and others as
appropriate)
Endo- and All species At least two tests, one Testing methods and
ectoparasites of which should be at antiparasitic treatment as
the start, the other appropriate to species of
towards the end of the animal and parasitic agent.
quarantine
Veterinary Administrations of importing countries should not normally require any tests for viral diseases or
for tuberculosis. However, stringent precautions to ensure human health and safety should be followed as
recommended in Article 2.10.1.7.
Article 2.10.1.6.
Certification and quarantine requirements for other non-human primates from premises under
veterinary supervision
for prosimians, New World monkeys, Old World monkeys, gibbons and great apes from premises under
veterinary supervision
1. the presentation of an international veterinary certificate attesting that the shipment meets the
requirements specified in Article 2.10.1.3., and that the animals:
a) are either born in the premises of origin or have been kept there for at least 2 years;
b) come from premises which are under permanent veterinary supervision, and where a suitable
health monitoring programme is followed, including microbiological and parasitological tests as
well as necropsies;
c) have been kept in buildings and enclosures in which no case of tuberculosis has occurred during
the last 2 years prior to shipment;
d) come from premises in which no case of tuberculosis or other zoonoses including rabies has
occurred during the last 2 years prior to shipment in the building where the animals were kept;
e) were subjected to a tuberculosis test on two occasions with negative results, at an interval of at
least 2 weeks between each test during the 30 days prior to shipment;
f) were subjected to a diagnostic test for pathogenic enteric bacteria including Salmonella, Shigella
and Yersinia;
g) were subjected to diagnostic tests for, and appropriate treatment against, endo- and
ectoparasites;
h) were subjected to a diagnostic test for hepatitis B virus and their current status documented
(gibbons and great apes only);
2. the placement of the animals in a quarantine station for at least 30 days, and during this period:
a) all animals to be monitored daily for signs of illness and, if necessary, subjected to a clinical
examination;
b) all animals dying for any reason to be subjected to complete post-mortem examination at a
laboratory approved for this purpose;
c) any cause of illness or death to be determinated before the group to which the animals belong is
released from quarantine;
d) animals to be subjected to the following diagnostic tests and treatments in accordance with
Appendix 3.4.3.:
Other bacterial All species Daily test for 3 days Faecal culture. (See further
pathogens within the first 5 days comments in the Table of
(Salmonella, after arrival, and Article 2.10.1.4.)
Shigella, Yersinia another test at least
and others as 1 week later
appropriate)
Endo- and All species At least two tests, one Testing methods and
ectoparasites of which should be at antiparasitic treatment as
the start, the other appropriate to species of
towards the end of the animal and parasitic agent.
quarantine
Veterinary Administrations of importing countries should not normally require any tests for viral diseases.
However, stringent precautions to ensure human health and safety should be followed as recommended
in Article 2.10.1.7.
Article 2.10.1.7.
The presence in most non-human primates of some zoonotic agents is almost unavoidable, even after
release from quarantine. The relevant Authorities should, therefore, encourage the management of
institutions whose staff are exposed to non-human primates or their body fluids, faeces or tissues
(including when performing necropsies) to comply with the following guidelines:
1. to provide staff with training in the proper handling of primates, their body fluids, faeces and tissues,
with respect to zoonoses containment and personal safety;
2. to inform their staff that certain species should be considered lifetime as having lifelong infections
with some zoonotic agents, e.g. macaques with Herpes B virus;
3. to ensure that the staff follows personal hygiene practices, including the use of protective clothing,
and the prohibition of eating, drinking and smoking in potentially infective areas;
4. to implement a screening programme for personnel health, including monitoring for tuberculosis,
pathogenic enteric bacteria and endoparasites and other agents that are deemed necessary;
5. to implement an immunisation programme as appropriate, including e.g. tetanus, measles,
poliomyelitis, rabies, hepatitis A and B, and other diseases endemic in the area of origin of the
non-human primates;
6. to develop guidelines for the prevention and treatment of zoonoses that may be transmitted by bites
and scratches, e.g. rabies and herpes viruses;
7. to issue to their staff a card which states that they work with non-human primates or with their body
fluids, faeces or tissues, and which may be presented to the medical profession in case of illness;
8. to dispose of carcasses, body fluids, faeces and tissues in a manner which is not detrimental to public
health.
SALMONELLA ENTERITIDIS
AND SALMONELLA TYPHIMURIUM
IN POULTRY
Article 2.10.2.1.
Article 2.10.2.2.
Article 2.10.2.3.
2. come from a flock of birds within the establishment in which no evidence of Salmonella enteritidis or
Salmonella typhimurium has been detected and have had no contact with hatching eggs or material from
poultry flocks which do not comply with this standard;
3. come from an establishment which complies with the hygiene and disease security procedures referred
to in Appendix 3.4.1.;
4. were shipped in clean and unused packages.
APPENDICES
APPENDIX 3.1.1.
NOTE
In many of the Terrestrial Code chapters relating to specific diseases, the reader is referred to the Terrestrial
Manual for information on OIE standards for the relevant diagnostic tests and vaccines.
However, some readers of the Terrestrial Code may need to know which diagnostic tests are recommended
by the OIE for use in the international trade of animals or animal products, without requiring the details of
how these tests should be performed.
The tables in this Appendix have been included to meet this need. These tables show, for each OIE listed
diseases, the diagnostic tests which can be used when the Terrestrial Code recommends a testing procedure.
These tests should be performed according to the specifications in the Terrestrial Manual, in order to
avoid any differences between the exporting and importing countries in the interpretation of results.
In the tables, the diagnostic tests have been divided into two categories - 'prescribed tests' and 'alternative
tests' (a similar categorisation is made in the Terrestrial Manual). The 'prescribed tests' are those which are
considered optimal for determining the health status of animals before shipment. 'Alternative tests' do not
demonstrate the absence of infection in the tested animals with the same level of confidence as the
prescribed tests do. However, the OIE Terrestrial Animal Health Standards Commission considers that
an 'alternative test', chosen by mutual agreement between the importing and exporting countries, can provide
valuable information for evaluating the risks of any proposed trade in animals or animal products. The
disease for which the Terrestrial Code does not require any test are not included in the tables.
ABBREVIATIONS
Terrestrial Terrestrial
Disease Prescribed Alternative
Code Manual
name tests tests
chapter No. chapter No.
OIE listed diseases
Multiple species
2.2.2. 2.2.2. Aujeszky's disease ELISA, VN _
2.2.4. 2.2.4. Leptospirosis _ MAT
2.2.5. 2.2.5. Rabies VN ELISA
2.2.6. 2.2.6. Paratuberculosis _ DTH, ELISA
2.2.7. 2.2.7. Heartwater _ ELISA, IFA
New world screwworm
(Cochliomyia hominivorax) and
2.2.8. 2.2.8. _ Agent id.
old world screwworm
(Chrysomya bezziana)
2.2.9. 2.2.9. Trichinellosis Agent id. ELISA
2.2.10. 2.1.1. Foot and mouth disease1 ELISA, VN CF
2.2.11. 2.1.2. Vesicular stomatitis CF, ELISA, VN _
2.2.12. 2.1.4. Rinderpest ELISA VN
Agent id., AGID,
2.2.13. 2.1.9. Bluetongue VN
ELISA, PCR
2.2.14. 2.1.8. Rift Valley fever _ HI, ELISA, PRN
2.2.16. 2.8.2. Tularemia _ Agent id.
Cattle
BBAT, CF,
2.3.1. 2.3.1 . Bovine brucellosis _
ELISA, FPA
Bovine genital
2.3.2. 2.3.2. Agent id. _
campylobacteriosis
2.3.3. 2.3.3. Bovine tuberculosis Tuberculin test _
2.3.4. 2.3.4. Enzootic bovine leukosis AGID, ELISA PCR
Infectious bovine
VN, ELISA,
rhinotracheitis/
2.3.5. 2.3.5. Agent id. _
infectious pustular
(semen only)
vulvovaginitis
2.3.6. 2.3.6. Trichomonosis Agent id. Mucus agg.
2.3.7. 2.3.7. Bovine anaplasmosis _ CF, Agg. card
2.3.8. 2.3.8. Bovine babesiosis _ ELISA, IFA
2.3.9. 2.3.9. Bovine cysticercosis _ Agent id.
2.3.11. 2.3.11. Theileriosis Agent id., IFA _
2.3.12. 2.3.12. Haemorrhagic septicaemia _ Agent id.
2.3.14. 2.1.7. Lumpy skin disease _ VN
Terrestrial Terrestrial
Disease Prescribed Alternative
Code Manual
name tests tests
chapter No. chapter No.
OIE listed diseases (contd)
Contagious bovine
2.3.15. 2.1.6. CF, ELISA _
pleuropneumonia
Sheep and goats
Ovine epididymitis (Brucella
2.4.1. 2.4.1. CF ELISA
ovis)
Caprine and ovine brucellosis
2.4.2. 2.4.2. BBAT, CF Brucellin test
(excluding Brucella ovis)
2.4.4. 2.4.4. Caprine arthritis/encephalitis AGID, ELISA _
2.4.5. 2.4.5. Maedi-visna AGID, ELISA _
Contagious caprine
2.4.6. 2.4.6. CF _
pleuropneumonia
2.4.7. 2.4.7. Enzootic abortion of ewes _ CF
2.4.9. 2.1.5. Peste des petits ruminants VN ELISA
2.4.10. 2.1.10. Sheep pox and goat pox _ VN
Equines
2.5.1. 2.5.1. Contagious equine metritis Agent id. _
2.5.2. 2.5.2. Dourine CF IFA, ELISA
Equine encephalomyelitis
2.5.3. 2.5.3. _ HI, CF, PRN
(Eastern and Western)
2.5.4. 2.5.4. Equine infectious anaemia AGID ELISA
2.5.5. 2.5.5. Equine influenza _ HI
2.5.6. 2.5.6. Equine piroplasmosis IFA, ELISA CF
2.5.7. 2.5.7. Equine rhinopneumonitis _ VN
2.5.8. 2.5.8. Glanders Mallein test, CF _
VN, Agent id.
2.5.10. 2.5.10. Equine viral arteritis _
(semen only)
Venezuelan equine
2.5.12. 2.5.12. _ HI, CF, PRN
encephalomyelitis
2.5.14. 2.1.11. African horse sickness CF, ELISA VN
Swine
2.6.2. 2.6.2. Porcine brucellosis ELISA BBAT, FPA
Enterovirus
2.6.3. 2.6.3. _ VN
encephalomyelitis
2.6.4. 2.6.4. Transmissible gastroenteritis _ VN, ELISA
2.6.5. 2.1.3. Swine vesicular disease VN ELISA
2.6.6. 2.1.12. African swine fever ELISA IFA
Terrestrial Terrestrial
Disease Prescribed Alternative
Code Manual
name tests tests
chapter No. chapter No.
OIE listed diseases (contd)
NPLA, FAVN,
2.6.7. 2.1.13. Classical swine fever _
ELISA
Birds
2.7.1. 2.7.1. Infectious bursal disease _ AGID, ELISA
2.7.2. 2.7.2. Marek's disease _ AGID
Avian mycoplasmosis
2.7.3. 2.7.3. _ Agg., HI
(Mycoplasma gallisepticum)
Fowl typhoid and Pullorum
2.7.5. 2.7.5. _ Agg., Agent id.
disease
2.7.6. 2.7.6. Avian infectious bronchitis _ VN, HI, ELISA
Avian infectious AGID, VN,
2.7.7. 2.7.7. _
laryngotracheitis ELISA
Tuberculin test,
2.7.8. 2.7.8. Avian tuberculosis _
Agent id.
2.7.12. 2.1.14. Avian influenza _ AGID, HI
2.7.13. 2.1.15. Newcastle disease _ HI
Lagomorphs
2.8.1. 2.8.1. Myxomatosis _ AGID, CF, IFA
2.8.2. 2.8.3. Rabbit haemorrhagic disease _ HI
1 Please refer to the Terrestrial Manual's chapters to verify which method is prescripted
APPENDIX 3.2.1.
Article 3.2.1.1.
General considerations
Article 3.2.1.2.
Article 3.2.1.3.
1. The semen collection facilities should include separate and distinct areas for accommodating resident
animals, for semen collection, for feed storage, for manure storage, and for the isolation of suspect
animals.
2. Only animals associated with semen production should be permitted to enter the semen collection
facilities. Other species of animals may be resident at the centre, if necessary for the movement or
handling of the donors and teasers or for security, but contact with the donors and teasers should be
minimised. All animals resident at the semen collection facilities must meet the minimum health
requirements for donors.
3. The donors and teasers should be adequately isolated to prevent the transmission of diseases from
farm livestock and other animals. Measures should be in place to prevent the entry of wild animals
susceptible to OIE-listed ruminant diseases transmissible via semen.
4. Personnel at the centre should be technically competent and observe high standards of personal
hygiene to preclude the introduction of pathogenic organisms. Special protective clothing and
footwear for use only at the semen collection facilities should be provided and worn at all times
inside.
5. Visitors to the semen collection facilities should be kept to a minimum, and visits should be subject
to formal authorisation and control. Equipment for use with the livestock should be dedicated to the
semen collection facilities or disinfected prior to entry. All equipment and tools brought on to the
premises must be examined and treated if necessary to ensure that they cannot introduce disease.
6. Vehicles used for transport of animals to and from the semen collection facilities should not be
allowed to enter the facilities.
7. The semen collection area should be cleaned daily after collection. The animals’ accommodation and
semen collection areas should be cleaned and disinfected at least once a year.
8. Fodder introduction and manure removal should be done in a manner which poses no significant
animal health risk.
Article 3.2.1.4.
1. The semen laboratory should be physically separated from the semen collection facilities, and include
separate areas for artificial vagina cleaning and preparation, semen evaluation and processing, semen
pre-storage and storage. Entry to the laboratory should be prohibited to unauthorised personnel.
2. The laboratory personnel should be technically competent and observe high standards of personal
hygiene to preclude the introduction of pathogenic organisms during semen evaluation, processing
and storage.
3. Visitors to the laboratory should be kept to a minimum, and visits should be subject to formal
authorisation and control.
4. The laboratory should be constructed with materials that permit effective cleaning and disinfection.
5. The laboratory should be regularly cleaned. Work surfaces for semen evaluation and processing
should be cleaned and disinfected at the end of each workday.
6. The laboratory should be treated against rodents and insects on a regular basis as needed to control
these pests.
7. The storage rooms and individual semen containers should be easy to clean and disinfect.
8. Only semen collected from donors having a health status equivalent to or better than the donors at
the semen collection facilities should be processed in the laboratory.
Article 3.2.1.5.
Bulls and teaser animals can enter an artificial insemination centre only if they fulfil the requirements laid
down by the Veterinary Administration.
1. Pre-quarantine
The animals should comply with the following requirements prior to entry into isolation at the
quarantine station.
a) Bovine brucellosis
The animals should comply with point 3 or 4 of Article 2.3.1.5. of the Terrestrial Code.
b) Bovine tuberculosis
The animals should comply with point 3 or 4 of Article 2.3.3.4. of the Terrestrial Code.
c) Bovine viral diarrhoea-mucosal disease (BVD-MD)
The animals should be subjected to the following tests:
i) a virus isolation test or a test for virus antigen, with negative results;
ii) a serological test to determine the serological status of every animal.
d) Infectious bovine rhinotracheitis-infectious pustular vulvovaginitis (IBR/IPV)
If the artificial insemination centre is to be considered as IBR/IPV free, the animals should either:
i) come from an IBR/IPV free herd as defined in Article 2.3.5.3.; or
ii) be subjected, with negative results, to a serological test for IBR/IPV on a blood sample.
e) Bluetongue
The animals should comply with Article 2.2.13.6., 2.2.13.7. or 2.2.13.8. of the Terrestrial Code,
depending on the bluetongue status of the country of origin of the animals.
2. Testing in the quarantine station prior to entering the semen collection facilities
Prior to entering the semen collection facilities of the artificial insemination centre, bulls and teaser
animals should be kept in a quarantine station for at least 28 days. The animals should be subjected to
diagnostic tests as described below a minimum of 21 days after entering the quarantine station, except
for Campylobacter fetus subsp. venerealis and Trichomonas foetus, for which testing may commence after
7 days in quarantine. All the results should be negative except in the case of BVD-MD antibody
serological testing (see point 2b)i) below).
a) Bovine brucellosis
The animals should be subjected to a serological test with negative results.
b) BVD-MD
i) All animals should be tested for viraemia as described in point 1c) above.
Only when all the animals in quarantine test negative for viraemia, may the animals enter
the semen collection facilities upon completion of the 28-day quarantine period.
ii) After 21 days in quarantine, all animals should be subjected to a serological test to
determine the presence or absence of BVD-MD antibodies.
iii) Only if no sero-conversion occurs in the animals which tested seronegative before entry
into the quarantine station, may any animal (seronegative or seropositive) be allowed entry
into the semen collection facilities.
iv) If sero-conversion occurs, all the animals that remain seronegative should be kept in
quarantine over a prolonged time until there is no more seroconversion in the group for a
period of 3 weeks. Serologically positive animals may be allowed entry into the semen
collection facilities.
c) Campylobacter fetus subsp. venerealis
i) Animals less than 6 months old or kept since that age only in a single sex group prior to
quarantine should be tested once on a preputial specimen, with a negative result.
ii) Animals aged 6 months or older that could have had contact with females prior to
quarantine should be tested three times at weekly intervals on a preputial specimen, with a
negative result in each case.
d) Trichomonas foetus
i) Animals less than 6 months old or kept since that age only in a single sex group prior to
quarantine, should be tested once on a preputial specimen, with a negative result.
ii) Animals aged 6 months or older that could have had contact with females prior to
quarantine should be tested three times at weekly intervals on a preputial specimen, with a
negative result in each case.
e) IBR-IPV
If the artificial insemination centre is to be considered as IBR/IPV free, the animals should be
subjected, with negative results, to a diagnostic test for IBR/IPV on a blood sample. If any
animal tests positive, the animal should be removed immediately from the quarantine station and
the other animals of the same group should remain in quarantine and be retested, with negative
results, not less than 21 days after removal of the positive animal.
f) Bluetongue
The animals should comply with Article 2.2.13.9., 2.2.13.10. or 2.2.13.11. of the Terrestrial Code,
depending on the bluetongue status of the country of origin of the animals.
3. Testing for BVD-MD prior to the initial dispatch of semen from each serologically positive bull
Prior to the initial dispatch of semen from BVD-MD serologically positive bulls, a semen sample
from each animal should be subjected to a virus isolation or virus antigen ELISA test for BVD-MD.
In the event of a positive result, the bull should be removed from the centre and all of its semen
destroyed.
4. Testing of frozen semen for IBR/IPV in artificial insemination centres not considered as IBR/IPV
free
Each aliquot of frozen semen should be tested as per Article 2.3.5.7.
5. Testing programme for bulls and teasers resident in the semen collection facilities
All bulls and teasers resident in the semen collection facilities should be tested at least annually for
the following diseases, with negative results, where the country of origin is not free:
a) Bovine brucellosis
b) Bovine tuberculosis
c) BVD-MD
Animals negative to previous serological tests should be retested to confirm absence of
antibodies.
Should an animal become serologically positive, every ejaculate of that animal collected since the
last negative test should be either discarded or tested for virus with negative results.
d) Campylobacter fetus subsp. venerealis
i) A preputial specimen should be cultured.
ii) Only bulls on semen production or having contact with bulls on semen production need to
be tested. Bulls returning to collection after a lay off of more than 6 months should be
tested not more than 30 days prior to resuming production.
e) Bluetongue
The animals should comply with the provisions referred to in Article 2.2.13.9., 2.2.13.10. or
2.2.13.11. of the Terrestrial Code, depending on the bluetongue status of the country of origin of
the animals.
f) Trichomonas foetus
i) A preputial specimen should be cultured.
ii) Only bulls on semen production or having contact with bulls on semen production need to
be tested. Bulls returning to collection after a lay off of more than 6 months should be
tested not more than 30 days prior to resuming production.
g) IBR-IPV
If the artificial insemination centre is to be considered as IBR/IPV free, the animals should
comply with the provisions in point 2)c) of Article 2.3.5.3.
Article 3.2.1.6.
Rams/bucks and teaser animals can enter an artificial insemination centre only if they fulfil the requirements
laid down by the Veterinary Administration.
1. Pre-quarantine
The animals should comply with the following requirements prior to entry into isolation at the
quarantine station.
a) Caprine and ovine brucellosis
The animals should comply with Article 2.4.2.6.
b) Ovine epididymitis
The animals should comply with Article 2.4.1.3.
c) Contagious agalactia
The animals should comply with points 1 and 2 of Article 2.4.3.1.
d) Peste des petits ruminants
The animals should comply with points 1, 2, 4 and 5 of Article 2.4.9.7.
e) Contagious caprine pleuropneumonia
The animals should comply with Article 2.4.6.5. or Article 2.4.6.7., depending on the CCPP
status of the country of origin of the animals.
f) Caseous lymphadenitis
The animals should be free from clinical signs for the past 12 months.
g) Paratuberculosis
The animals should be free from clinical signs for the past 2 years.
h) Scrapie
If the animals do not originate from a scrapie free country or zone as defined in Article 2.4.8.3.,
the animals should comply with points 1 and 2 of Article 2.4.8.8.
i) Maedi-visna
The animals should comply with Article 2.4.5.2.
j) Caprine arthritis/encephalitis
The animals should comply with Article 2.4.4.2.
k) Bluetongue
The animals should comply with Article 2.2.13.6., 2.2.13.7. or 2.2.13.8., depending on the
bluetongue status of the country of origin of the animals.
l) Tuberculosis
In the case of goats, the animals should be subject to a single or comparative tuberculin test,
with negative results.
m) Border disease
The animals should be subject to a viral agent isolation test with negative results.
2. Testing in the quarantine station prior to entering the semen collection facilities
Prior to entering the semen collection facilities of the artificial insemination centre, rams/bucks and
teasers should be kept in a quarantine station for at least 28 days. The animals should be subjected to
diagnostic tests as described below a minimum of 21 days after entering the quarantine station, with
negative results.
a) Caprine and ovine brucellosis
The animals should be subject to testing as described in point 1 b) or c) of Article 2.4.2.8.
b) Ovine epididymitis
The animals and semen should be subject to testing as described in points 1d) and 2 of
Article 2.4.1.4.
c) Maedi-visna or CAE
The animals should be subjected to a serological test.
d) Bluetongue
The animals should comply with the provisions referred to in Article 2.2.13.9., 2.2.13.10. or
2.2.13.11., depending on the bluetongue status of the country of origin of the animals.
3. Testing programme for rams/bucks and teasers resident in the semen collection facilities
All rams/bucks and teasers resident in the semen collection facilities should be tested at least
annually for the following diseases, with negative results, where the country of origin is not free:
a) caprine and ovine brucellosis;
b) ovine epididymitis;
c) Maedi-visna or CAE;
d) tuberculosis (for goats only);
e) bluetongue.
Article 3.2.1.7.
Observation of the recommendations described in the Articles below will very significantly reduce the
likelihood of the semen being contaminated with common bacteria which are potentially pathogenic.
Article 3.2.1.8.
The objective is to keep the animals in a satisfactory state of cleanliness, particularly of the lower thorax
and abdomen.
1. Whether on pasture or housed, the animal should be kept under hygienic conditions. If housed, the
litter must be kept clean and renewed as often as necessary.
2. The coat of the animal should be kept clean.
3. For bulls, the length of the tuft of hairs at the preputial orifice, which is invariably soiled, should be
cut to about 2 cm. The hair should not be removed altogether, because of its protective role. If cut
too short, irritation of the preputial mucosa may result because these hairs aid the drainage of urine.
4. The animal should be brushed regularly, and where necessary on the day before semen collection,
paying special attention to the underside of the abdomen.
5. In the event of obvious soiling, there should be careful cleaning, with soap or a detergent, of the
preputial orifice and the adjoining areas, followed by thorough rinsing and drying.
6. When the animal is brought into the collection area, the technician must make sure that it is clean,
and that it is not carrying any excessive litter or particles of feed on its body or its hooves, for such
materials are always heavily contaminated.
Measures similar to the above should be adapted to rams and bucks.
Article 3.2.1.9.
1. The floor of the mounting area should be easy to clean and to disinfect. A dusty floor should be
avoided.
2. The hindquarters of the teaser, whether a dummy or a live teaser animal, must be kept clean. A
dummy must be cleaned completely after each period of collection. A teaser animal must have its
hindquarters cleaned carefully before each collecting session. The dummy or hindquarters of the
teaser animal should be sanitized after the collection of each ejaculate. Disposable plastic covers may
be used.
3. The hand of the person collecting the semen must not come into contact with the animal’s penis.
Disposable gloves should be worn by the collector and changed for each collection.
4. The artificial vagina must be cleaned completely after each collection. It should be dismantled, its
various parts washed, rinsed and dried, and kept protected from dust. The inside of the body of the
device and the cone should be disinfected before re-assembly using approved disinfection techniques
such as those involving the use of 70° ethyl or 98-99° isopropyl alcohol, ethylene oxide or steam.
Once re-assembled, it should be kept in a cupboard which is regularly cleaned and disinfected.
5. The lubricant used should be clean. The rod used to spread the lubricant must be clean and should
not be exposed to dust between successive collections.
6. The artificial vagina should not be shaken after ejaculation, otherwise lubricant and debris may pass
down the cone to join the contents of the collecting tube.
7. When successive ejaculates are being collected, a new artificial vagina should be used for each
mounting. The vagina should also be changed when the animal has inserted its penis without
ejaculating.
8. The collecting tubes should be sterile, and either disposable or sterilised by autoclaving or heating in
an oven at 180°C for at least 30 minutes. They should be kept sealed to prevent exposure to the
environment while awaiting use.
9. After semen collection, the tube should be left attached to the cone and within its sleeve until it has
been removed from the collection room for transfer to the laboratory.
Article 3.2.1.10.
Conditions applicable to the handling of semen and preparation of semen samples in the
laboratory
1. Diluents
a) All receptacles used should have been sterilised.
b) Buffer solutions employed in diluents prepared on the premises should be sterilized by filtration
(0.22 µm) or by autoclaving (121°C for 30 minutes) or be prepared using sterile water before
adding egg yolk (if applicable) or equivalent additive and antibiotics.
c) If the constituents of a diluent are supplied in commercially available powder form, the water
used must have been distilled or demineralised, sterilized (121°C for 30 minutes or equivalent),
stored correctly and allowed to cool before use.
d) When egg yolk is used, it should be separated from eggs using aseptic techniques. Alternatively,
commercial egg yolk prepared for human consumption or egg yolk treated by, for example,
pasteurisation or irradiation to reduce bacterial contamination, may be used. Other additives
must also be sterilized before use.
e) Diluent should not be stored for more than 72 hours at +5°C before use. A longer storage
period is permissible for storage at -20°C. Storage vessels should be stoppered.
f) A mixture of antibiotics should be included with a bactericidal activity at least equivalent to that
of the following mixtures in each ml of frozen semen: either gentamicin (250 µg), tylosin
(50 µg), lincomycin-spectinomycin (150/300 µg) or penicillin (500 IU), streptomycin (500 µg),
lincomycin-spectinomycin (150/300 µg).
The names of the antibiotics added and their concentration should be stated in the international
veterinary certificate.
2. Procedure for dilution and packing
a) The tube containing freshly collected semen should be sealed as soon as possible after
collection, and kept sealed until processed.
b) After dilution and during refrigeration, the semen should also be kept in a stoppered container.
c) During the course of filling receptacles for dispatch (such as insemination straws), the
receptacles and other disposable items should be used immediately after being unpacked.
Materials for repeated use should be sterilised with alcohol, ethylene oxide, steam or other
approved sterilisation techniques.
d) If sealing powder is used, care should be taken to avoid its being contaminated.
1 The ICAR international standards on straws are contained in Recording Guidelines - Appendices
to the international agreement of recording practices. Section 9, Appendix B relating to semen
straw identification.
The text of this document is available at the following web site: www.icar.org
PORCINE SEMEN
Article 3.2.2.1.
2. The centre should be under the direct supervision and sanitary control of an Official Veterinarian.
3. The centre should be under the overall supervision of the Veterinary Administration, which is
responsible for routine visits to check the health and welfare of animals, and the procedures and
prescribed records at the centre at least every 6 months.
4. Only swine associated with semen production should be permitted to enter the centre. Other species
of livestock may exceptionally be resident on the centre, provided that they are kept physically apart
from the swine.
5. Swine on the centre should be adequately isolated from farm livestock on adjacent land or buildings
for instance by natural or artificial means.
6. The entry of visitors should be strictly controlled. Personnel at a centre should be technically
competent and observe high standards of personal hygiene to preclude the introduction of
pathogenic organisms. Protective clothing and footwear for use only on the centre should be
provided.
7. Individual semen containers and storage rooms should be capable of being disinfected.
Article 3.2.2.2.
1. Boars should only enter an artificial insemination centre if they fulfil the requirements laid down by the
Veterinary Administration.
2. The semen from boars with genetic defects or associated with genetic defects in near relatives may
not be eligible for export.
3. Boars must be clinically healthy and physiologically normal and must pass pre-entry tests within the
30 days prior to entry into isolation at an artificial insemination centre. The prescribed diseases and tests
are listed in point 2. of Article 3.2.2.3.
4. Boars must remain in isolation at an artificial insemination centre for a period of at least 30 days before
being retested to meet the standards listed in Article 3.2.2.3. Boars may only enter the stud on the
successful completion of these tests and must be clinically healthy.
Article 3.2.2.3.
1. Definitions
Prescribed tests cover a minimal range of diseases from which all boars on an artificial insemination
centre must be free.
Routine tests are tests applied at regular intervals to confirm the continued freedom from disease of
the stud.
2. Prescribed tests
a) Bovine tuberculosis
Boars to give negative results to intradermal tuberculin tests with mammalian tuberculin in
accordance with the Terrestrial Manual.
b) 1Brucellosis (B. abortus, B. suis)
Boars to give negative results to serological tests in accordance with the Terrestrial Manual.
3. Routine tests
a) 1Swine vesicular disease
Boars to give negative results to a serum-neutralisation test in accordance with the Terrestrial
Manual (see also Articles 2.6.5.9. and 2.6.5.10. of this Terrestrial Code).
Routine tests to be applied at least every 12 months.
b) 1African swine fever
Boars to give negative results to enzyme-linked immunoabsorbent assay and indirect
immunofluorescent tests in accordance with the Terrestrial Manual (see also Articles 2.6.6.10.
and 2.6.6.11. of this Terrestrial Code).
Routine tests to be applied at least every 6 months.
c) 1Enterovirus encephalomyelitis (ex Teschen disease)
Boars to meet certification standards in Articles 2.6.3.9. or 2.6.3.10. of this Terrestrial Code.
Routine tests to be applied at least every 12 months.
d) 1Vesicular stomatitis
Boars to give negative results to a complement fixation test in accordance with the Terrestrial
Manual.
Routine tests to be applied at least every 12 months.
Claims of country freedom from some viral and bacterial infections of swine may be given consideration
providing such claims are backed by serological survey data and epidemiological investigation.
Article 3.2.2.4.
Artificial insemination centres may be required by the Veterinary Administration to include in their veterinary
prophylactic programmes a number of other diseases, either through vaccination or by requiring negative
results to serological tests.
Additionally, some importing countries may require assurances of freedom from a disease (for example:
classical swine fever, Aujeszky's disease) based on negative serology or other biological tests. The range of
infections to be covered is extensive and beyond the capacity of artificial insemination centres to support
totally. Thus, only optional tests remain to be applied and interpreted by bilateral agreement when
importation of semen is being considered.
Where a disease is covered by a Chapter in this Terrestrial Code, the testing requirements of the Chapter
should be followed.
Records of the progeny of a donor boar should be maintained as far as possible to determine that he is
not associated with any genetic defect. The records of the boar should indicate his fertility. The semen
must be obtained from a boar with a normal libido.
Article 3.2.2.5.
Whenever milk, egg yolk or any other animal protein is used in preparing the semen diluent, the product
must be free of pathogens or sterilised; milk heat-treated at 92°C for 3-5 minutes, eggs from SPF flocks
when available. The inclusion of penicillin, streptomycin, polymixin etc. is permitted, provided that this is
declared in the international veterinary certificate.
Article 3.2.2.6.
Semen for export should be stored separately in fresh liquid nitrogen in sterilised flasks for at least
28 days.
The examination of ejaculates, and the dilution and freezing of semen must be carried out in a laboratory
maintaining the hygienic standards set by the Veterinary Administration. The pre-sperm fraction should not
be included in material to be stored. Only semen of a health standard equivalent to that produced in an
artificial insemination centre should be handled.
Semen straws or pellets shall be code marked in line with national standards.
Containers must be sealed before export and accompanied by an international veterinary certificate listing the
contents.
1 In countries where the diseases marked with an asterisk have not occurred and where country
freedom is claimed in accordance with the criteria set out in the relative chapter of this
Terrestrial Code, the pre-entry/post-entry and routine tests may be dispensed with.
APPENDIX 3.3.1.
Article 3.3.1.1.
Aims of control
The purpose of official sanitary control of in vivo derived embryos intended for movement internationally
is to ensure that specific pathogenic organisms, which could be associated with embryos, are controlled
and transmission of infection to recipient animals and progeny is avoided.
Article 3.3.1.2.
The embryo collection team is a group of competent technicians, including at least one veterinarian, to
perform the collection, processing and storage of embryos. The following conditions should apply:
1. The team should be supervised by a team veterinarian.
2. The team veterinarian is responsible for all team operations which include verification of donor
health status, sanitary handling and surgery of donors and disinfection and hygienic procedures.
3. The team veterinarian should be specifically approved for this purpose by an Official Veterinarian.
4. Team personnel should be adequately trained in the techniques and principles of disease control.
High standards of hygiene should be practiced to preclude the introduction of infection.
5. The collection team must have adequate facilities and equipment for:
a) collecting embryos;
b) processing and treatment of embryos at a permanent site or mobile laboratory;
c) storing embryos.
These facilities need not necessarily be at the same location.
6. The collection team must keep a record of its activities, which must be maintained for inspection by
the approving authority for a period of at least 2 years after the embryos have been exported.
7. The collection team should be subjected to inspection at least once a year by an Official Veterinarian
to ensure compliance with sanitary collection, processing and storage of embryos.
8. The collection team must not operate in an infected zone with regard to foot and mouth disease
(except for the collection of in vivo derived bovine embryos), rinderpest, peste des petits ruminants,
contagious bovine pleuropneumonia, African horse sickness, African swine fever and classical swine
fever.
Article 3.3.1.3.
The processing laboratory used by the embryo collection team may be mobile or permanent. It is a facility
in which embryos are recovered from collection media, examined and subjected to any required
treatments such as washing before freezing, storage and quarantine, pending results of diagnostic
procedures.
A permanent laboratory may be part of a specifically designed collection and processing unit, or a suitably
adapted part of an existing building. It may be on the premises where the donor animals are kept. In
either case, the laboratory should be physically separated from animals. Both mobile and permanent
laboratories should have a clear separation between dirty areas (animal handling) and the clean processing
area.
Additionally:
1. The laboratory should be under the direct supervision of the team veterinarian and regularly
inspected by an Official Veterinarian.
2. While embryos for export are being handled prior to their storage in ampules, vials or straws, no
embryos of a lesser health status should be processed.
3. The laboratory should be protected against rodents and insects.
4. The processing laboratory should be constructed with materials which permit its effective cleansing
and disinfection. This should be done following each occasion on which embryos are processed.
5. The laboratory must not be situated in an infected zone with regard to foot and mouth disease (except
for the collection of in vivo derived bovine embryos), rinderpest, peste des petits ruminants,
contagious bovine pleuropneumonia, African horse sickness, African swine fever and classical swine
fever.
Article 3.3.1.4.
1. Donor animals
a) The Veterinary Administration should have knowledge of, and authority over, the herd/flock of
origin of the donor animals.
b) At the time of collection, donor animals should be clinically inspected by a veterinarian
responsible to the team veterinarian and certified to be free of clinical signs of diseases not
included in Category 1 of the IETS classification1.
c) The herd of origin must not be situated in an infected zone for the 30 days (60 days in the case of
camelids) before and after embryo collection, with regard to foot and mouth disease (except for
the collection of in vivo derived bovine embryos), rinderpest, peste des petits ruminants,
contagious bovine pleuropneumonia, African horse sickness, African swine fever and classical
swine fever.
d) The donor animals should not have been imported from another country during the previous
60 days and should have been in the herd of origin for at least 30 days prior to collection.
2. Semen donors
a) Semen used to inseminate donor animals artificially should have been produced and processed
in accordance with the provisions of Appendix 3.2.1. or Appendix 3.2.2., as relevant.
b) When the donor of the semen used to inseminate donor females for embryo production is no
longer living, and when the health status of the semen donor concerning a particular infectious
disease or diseases of concern was not known at the time of semen collection, additional tests
may be required of the inseminated donor female after embryo collection to verify that these
infectious diseases were not transmitted. An alternative may be to subject an aliquot of semen
from the same collection date to testing.
c) Where natural service or fresh semen is used, donor sires should meet the same health
requirements as donor females.
Article 3.3.1.5.
Risk management
With regard to disease transmission, transfer of in vivo derived embryos is a very low risk method for
moving animal genetic material. Irrespective of animal species, there are three phases in the embryo
transfer process that determine the final level of risk:
1. The first phase, which is applicable to diseases not included in Category 1 of the IETS classification1,
comprises the potential for embryo contamination and depends on:
a) the disease situation in the exporting country and/or zone;
b) the health status of the herds/flocks and the donors from which the embryos are collected;
c) the pathogenic characteristics of the specified disease agents.
2. The second phase covers risk mitigation by use of internationally accepted procedures for processing
of embryos which are set out in the IETS Manual2. These include the following:
a) The embryos must be washed at least ten times with at least 100-fold dilutions between each
wash, and a fresh pipette for transferring the embryos through each wash.
b) Only embryos from the same donor should be washed together.
c) Sometimes, for example when inactivation or removal of certain virus (e.g. bovine
herpesvirus-1, and Aujeszky's disease virus) is required, the standard washing procedure should
be modified to include additional washes with the enzyme trypsin, as described in the IETS
Manual2.
d) The zona pellucida of each embryo, after washing, must be examined over its entire surface area
at not less than 50X magnification to ensure that it is intact and free of adherent material.
[NOTE: All shipments of embryos must be accompanied by a statement signed by the team veterinarian
certifying that these embryo processing procedures have been completed.]
3. The third phase, which is applicable to diseases not included in Category 1 of the IETS classification,
encompasses the risk reductions resulting from:
a) post-collection surveillance of the donors and donor herds based on the recognized incubation
periods of the diseases of concern to determine retrospectively the health status of donors whilst
the embryos are stored (in species where effective cryopreservation is possible) in the exporting
country;
b) testing of embryo-collection (flushing) fluids and non-viable embryos, or other samples such as
blood, for presence of specified disease agents.
Article 3.3.1.6.
1. Media
Any biological product of animal origin used in the media and solutions for collection, processing,
washing or storage of embryos should be free of pathogenic micro-organisms. Media and solutions
used in the collection, freezing and storage of embryos should be sterilized by approved methods
according to the IETS Manual2 and handled in such a manner as to ensure that sterility is maintained.
Antibiotics should be added to collection, processing, washing and storage media as recommended in
the IETS Manual2.
2. Equipment
a) All equipment used to collect, handle, wash, freeze and store embryos should be sterilized prior
to use as recommended in the IETS Manual2.
b) Used equipment should be transferred between countries for re-use by the embryo collection
team only if cleaning and disinfection procedures appropriate to the disease risk concerned are
followed.
Article 3.3.1.7.
1. The examination of embryos and collection or washing fluids can be requested by an importing
country. Tests may be carried out on these samples to confirm the absence of pathogenic organisms,
or to assess whether the degree of quality control of the collection team is at an acceptable level:
a) Embryos/oocytes
Where the viable, zona intact embryos are intended for export, all non-fertilized oocytes and
degenerated or zona compromised embryos collected from a donor should be washed
according to the IETS Manual2 and pooled for possible testing. Only embryos/oocytes from
one donor should be processed simultaneously.
b) Collection fluids
The collection fluid should be placed in a sterile, closed container and, if there is a large amount,
it should be allowed to stand undisturbed for one hour. The supernatant fluid should then be
removed and the bottom 10-20 ml, along with accumulated debris, decanted into a sterile bottle.
If a filter is used in the collection of embryos/oocytes then any debris that is retained on the
filter must be rinsed into the retained fluid.
c) Washing fluids
The last four washes of the embryos/oocytes (washes 7, 8, 9 and 10) should be pooled (IETS
Manual2).
d) Samples
The samples referred to above should be stored at 4°C and tested within 24 hours. If this is not
possible, then samples should be stored frozen at -70°C or lower.
2. When treatment of the viable embryos is modified to include additional washings with the enzyme
trypsin (see paragraph 2c) in Article 3.3.1.5.), the procedure should be carried out according to the
IETS Manual2. It should be noted that such enzymatic treatment is not necessarily always beneficial
and it should not be regarded as a general disinfectant. It may also have adverse effects on embryo
viability, for instance in the case of equine embryos where the embryonic capsule could be damaged
by the enzyme.
Article 3.3.1.8.
1. Embryos should be frozen in fresh liquid nitrogen and then stored in fresh liquid nitrogen in cleaned
and disinfected tanks or containers.
2. The embryos should be stored in sealed sterile ampoules, vials or straws under strict hygienic
conditions at a storage place approved by the Veterinary Administration of the exporting country where
there is no risk of contamination of the embryos.
3. Only embryos from the same donor should be stored together in the same ampoule, vial or straw.
4. Ampoules, vials or straws must be sealed at the time of freezing (or prior to export where
cryopreservation is not possible), and they should be clearly identified by labels according to the
standardised system recommended in the IETS Manual2
5. Liquid nitrogen containers should be sealed under the supervision of the Official Veterinarian prior to
shipment from the exporting country.
6. Embryos must not be exported until the appropriate veterinary certification documents are
completed.
Article 3.3.1.9.
The herd of origin should be free of clinical signs of swine vesicular disease, brucellosis and pathogenic
enterovirus encephalomyelitis.
[NOTE: The development of effective cryopreservation methods for zona pellucida-intact porcine embryos is still at a
very early stage.]
Article 3.3.1.10.
The herd of origin should be free of clinical signs of sheep pox, goat pox, brucellosis and bluetongue.
Article 3.3.1.11.
The recommendations apply principally to embryos from animals continuously resident in national equine
populations and therefore may be found to be unsuitable for those from equines routinely involved in
events or competitions at the international level. For instance, in appropriate circumstances horses
travelling with an international veterinary certificate (e.g. competition horses) may be exempt from this
condition where mutually agreed upon on a bilateral basis between the respective Veterinary
Administrations.
Article 3.3.1.12.
South American camelid embryos recovered from the uterine cavity by the conventional non-surgical
flushing technique at 6.5 to 7 days post-ovulation are almost invariably at the hatched blastocyst stage,
and thus the zona pellucida has already been shed. Since the embryos do not enter the uterus and cannot
be recovered before 6.5 to 7 days, it would be unrealistic to stipulate for South American camelids that
only zona pellucida-intact embryos can be used in international trade. It must also be noted that pathogen
interaction studies with South American camelid embryos have not yet been carried out.
The herd of origin should be free of clinical signs of vesicular stomatitis, bluetongue, brucellosis and
tuberculosis.
[NOTE: The development of cryopreservation methods for camelid embryos is still at a very early stage.]
Article 3.3.1.13.
The recommendations apply principally to embryos derived from animals continuously resident in
national domestic or ranched cervid populations and therefore may be found to be unsuitable for those
from cervids in feral or other circumstances related to biodiversity or germplasm conservation efforts.
The herd of origin should be free of clinical signs of brucellosis and tuberculosis.
1 Based on available research and field information, the Research Subcommittee of the
International Embryo Transfer Society (IETS) has categorised some diseases based on their
relative risk of dissemination by properly processed and handled in vivo derived embryos.
Appendix 3.3.5. contains the list of IETS categorised diseases.
Article 3.3.2.1.
The embryo production team is a group of competent technicians, including at least one veterinarian, to
perform the collection and processing of ovaries/oocytes and the production and storage of in vitro
fertilised (IVF) embryos. The following conditions should apply:
1. The team should be supervised by a team veterinarian.
2. The team veterinarian is responsible for all team operations which include hygienic collection of
ovaries and oocytes and all other procedures involved in the production of embryos intended for
international movement.
3. The team veterinarian should be specifically approved for this purpose by an Official Veterinarian.
4. Team personnel should be adequately trained in the techniques and principles of disease control.
High standards of hygiene should be practised to preclude the introduction of infection.
5. The production team must have adequate facilities and equipment for:
a) collecting oocytes;
b) processing of oocytes and embryos;
c) storing embryos.
6. The collection team must keep a record of its activities, which must be maintained for inspection by
the approving authority for a period of at least 2 years after the embryos have been exported.
7. The production team should be subjected to regular inspection by an Official Veterinarian to ensure
compliance with sanitary collection and processing of oocytes and production and storage of
embryos.
8. The production team must not operate in an infected zone for foot and mouth disease and rinderpest.
Article 3.3.2.2.
The processing laboratory is a premises in which oocytes which have been recovered from ovaries are
then matured and fertilised, and embryos are further cultured in vitro. It may be contiguous with the
oocyte recovery area or may be at a separate location.
Embryos so produced may also be subjected to any required treatments such as washing before freezing,
storage and quarantine in this laboratory.
Additionally:
1. The laboratory should be under the direct supervision of the team veterinarian and regularly
inspected by an Official Veterinarian.
2. While embryos for export are being produced prior to their storage in ampules, vials or straws, no
oocyte/embryo of a lesser health status should be recovered or processed in the laboratory.
4. The processing laboratory should be constructed with materials which permit its effective cleansing
and disinfection. This should be done following each occasion on which embryos are processed.
5. The laboratory must not be situated in an infected zone for foot and mouth disease or rinderpest.
Article 3.3.2.3.
Oocytes for the production of IVF embryos are obtained from donors in one of two ways: individual
collection or batch collection. The recommended sanitary conditions for these differ.
Individual collection usually involves the aspiration of oocytes from the ovaries of live animals on the
farm where the donor animal resides or at the laboratory. Occasionally oocytes may also be recovered
from individual live donors by aspiration from surgically excised ovaries. When oocytes are recovered
from individual live animals, the procedures for these donors should follow the recommendations set out
in Article 3.3.1.4.
Cleaning and sterilisation of equipment is especially important and must be carried out between each
donor in accordance with the requirements of the Procedures Manual of the International Embryo
Transfer Society (IETS)2.
Batch collection usually involves the removal of ovaries from slaughtered animals at an abattoir but may
alternatively involve the surgical removal of ovaries from live donors; these ovaries are then transported
to the laboratory where oocytes are removed by aspiration. Batch collection involving abattoir derived
ovaries has the disadvantage that it is usually impractical to relate ovaries which are transported to the
laboratory to the donors which were slaughtered at the abattoir. Nevertheless, it is critical to ensure that
only healthy tissues are obtained and that they are removed from the donors in a hygienic manner.
Additionally:
1. The Veterinary Administration should have knowledge of, and authority over, the herd(s) of origin of
the donor animals.
2. The donor females should not originate from an infected zone for foot and mouth disease or
rinderpest and the removal of any tissue should not take place in an infected zone for foot and mouth
disease or rinderpest.
3. The abattoir should be officially approved and under the supervision of a veterinarian whose
responsibility it is to ensure that ante-mortem and post-mortem inspections of potential donor
animals are carried out and to certify them to be free of signs of contagious diseases of concern
transmissible to cattle.
4. The donor females should not have been designated for compulsory slaughter for a notifiable disease
and other animals of a lesser health status must not be slaughtered at the same time as donors from
which ovaries and other tissues will be removed.
6. Batches of ovaries should not be transported to the processing laboratory before confirmation has
been obtained that ante and post-mortem inspection of donors has been satisfactorily completed.
7. Equipment for removal and transport of ovaries and other tissues should be cleaned and sterilised
before use and exclusively used for these purposes.
Article 3.3.2.4.
The main approach for ensuring IVF embryos are free of pathogenic organisms is the testing of
non-viable oocytes/embryos and associated co-culture cells, fluid and media.
Tests may also be used to assess whether quality control procedures being applied in the processing
laboratory are acceptable.
Tests may be carried out on the following materials to confirm the absence of pathogenic organisms
which are of concern to the importing country:
a) non-viable oocytes/embryos: all non-viable oocytes/embryos at any stage of the production line
from batches intended for export should be pooled for testing;
b) in vitro maturation medium prior to mixing the oocytes with semen for the fertilisation process;
c) embryo culture medium taken immediately prior to embryo storage.
These samples should be stored at 4°C and tested within 24 hours. If this is not possible, then the
samples should be stored frozen at -70°C or lower.
In the case of oocyte recovery from individual animals or batch collection from live donors, monitoring
of clinical health status and post collection testing of donors for diseases of concern may be considered.
Additionally:
1. Semen used to fertilise oocytes in vitro should meet the health requirements and standards set out in
Appendix 3.2.1.
When the donor of the semen used to fertilise the oocytes is no longer living, and when the health
status of the semen donor concerning a particular infectious disease or diseases of concern was not
known at the time of semen collection, additional tests on the spare IVF embryos may be required to
verify that these infectious diseases were not transmitted. An alternative may be to subject an aliquot
of semen from the same collection date to testing.
2. Any biological product of animal origin, including co-culture cells and media constituents, used in
oocyte recovery, maturation, fertilisation, culture, washing and storage should be free of living
pathogenic micro-organisms. Media should be sterilised by approved methods according to the IETS
Manual2 and handled in such a manner as to ensure that sterility is maintained. Antibiotics should be
added to all fluids and media as recommended in the IETS Manual2.
3. All equipment used to recover, handle, culture, wash, freeze and store oocytes/embryos should be
cleaned and sterilised prior to use as recommended in the IETS Manual2.
Article 3.3.2.5.
1. After the culture period is finished but prior to freezing, storage and transport, the embryos should
be subjected to washing and other treatments similar to those specified for in vivo derived embryos in
accordance with the IETS Manual2.
2. Only embryos from the same donor, in the case of individual animal recovery, or from the same
batch collection, should be washed together.
3. The zona pellucida of each embryo must be examined over its entire surface area at not less than
50X magnification and certified to be intact.
4. The IVF embryos should be stored in sealed sterile ampules, vials or straws and then frozen in fresh
liquid nitrogen or other cryoprotectant in cleaned and sterilised containers under strict hygienic
conditions at a storage place, approved by the Veterinary Administration of the exporting country, where
no risk of contamination of the embryos can occur.
5. Only embryos from the same individual donor or batch collection should be stored together in the
same ampule, vial or straw.
6. Ampules, vials or straws must be sealed at the time of freezing and should be labelled according to
the IETS Manual2.
7. Liquid nitrogen containers should be sealed prior to shipment from the exporting country.
8. Embryos must not be exported until the appropriate veterinary certification documents are
completed.
Article 3.3.2.6.
When micromanipulation of the embryos is to be carried out, this should be done after completion of the
treatments described in Article 3.3.2.5. and conducted in accordance with Appendix 3.3.3.
1 Where transportation of in vitro maturing (IVM) oocytes is intended, the conditions outlined in
this Appendix are also applicable.
An up-to-date list of relevant scientific publications is available on the IETS Website Homepage
at http://www.iets.uiue.edu where the link entitled 'Embryo-Pathogen Research and Reference
Lists' may be visited.
Article 3.3.3.1.
Introduction
Appendix 3.3.1. recommends official sanitary control measures for the international movement of intact,
in vivo derived bovine embryos, and likewise Appendix 3.3.2. recommends measures for in vitro fertilized
bovine embryos/in vitro maturing oocytes. Neither of those Appendices covers embryos which have been
subjected to biopsy, splitting, transgene injection, intracytoplasmic sperm injection (ICSI), nuclear
transplantation or other micromanipulations which breach the integrity of the zona pellucida. Such
embryos are subsequently referred to here as 'micromanipulated embryos'.
It should be noted that complete removal of granulosa cells prior to micromanipulation of oocytes,
zygotes and embryos is necessary to avoid lowering their health status.
To bring micromanipulated embryos within the scope of the above mentioned Appendices, the following
conditions shall apply:
Article 3.3.3.2.
1. Prior to any micromanipulation which involves breaching the zona pellucida, all embryos/oocytes
must be collected and processed according to the sanitary conditions laid down in Appendix 3.3.1.
(in vivo derived embryos) or produced according to the sanitary conditions laid down in
Appendix 3.3.2. (in vitro fertilised bovine embryos/in vivo maturing oocytes).
2. Responsibility for the embryos/oocytes must remain with the embryo collection team (in vivo derived
embryos) or with the embryo production team (in vitro fertilised bovine embryos), and all processing
involving micromanipulation should be carried out in an approved processing laboratory under
supervision of an approved team veterinarian (see Articles 3.3.1.2. and 3.3.1.3., and Articles 3.3.2.1.
and 3.3.2.2., as relevant).
3. Donor animals must comply with the conditions laid down in Article 3.3.1.4. (in vivo derived
embryos) or Article 3.3.2.3. (in vitro fertilised bovine embryos/in vivo maturing oocytes), whichever is
appropriate. The criteria for testing samples to ensure that embryos are free of pathogenic organisms
are laid down in Article 3.3.1.5. and Article 3.3.2.4. respectively, and these should be followed.
4. All embryos to be micromanipulated must be washed according to the protocols laid down in the
IETS Manual (1998)1 and they must be observed to have an intact zona pellucida before and after
washing. Only embryos from the same donor, or, in the case of some in vitro produced embryos (see
Appendix 3.3.2.) from the same batch collection, should be washed together at the same time. After
washing, but before micromanipulation, the zona pellucida of each embryo should be examined over
its entire surface area at not less than 50X magnification and certified to be intact and free of
adherent material.
5. If surrogate zonae are used, they should be of bovine origin and the embryos/oocytes from which
they are obtained should be treated in the same manner as if they were in vivo derived or in vitro
produced embryos intended for international movement.
Article 3.3.3.3.
The term ‘micromanipulation’ covers several different procedures and a variety of specialised
microsurgical instruments and other equipment may be used. However, from the standpoint of animal
health, any cutting, penetrating or breaching of the integrity of the zona pellucida is an action that can
alter the health status of an embryo. To maintain health status during and after micromanipulation, the
following conditions should apply:
1. Media
Any product of animal origin, including co-culture cells and media constituents, used in the
collection of embryos, oocytes or other cells, and in their micromanipulation, culture, washing and
storage should be free of pathogenic micro-organisms (including transmissible spongiform
encephalopathy agents, sometimes called prions). All media and solutions should be sterilized by
approved methods according to the IETS Manual1 and handled in such a manner as to ensure that
sterility is maintained. Antibiotics should be added to all fluids and media as recommended in the
IETS Manual1.
2. Equipment
Equipment (e.g. microsurgical instruments which have direct contact with embryos) should either be
of the single-use type (disposed of after each embryo) or should be effectively sterilised between
embryos in accordance with recommendations in the IETS Manual1.
3. Nuclei for transfer
a) Where it is intended to transplant nuclei derived from pre-hatching stage (i.e. zona pellucida
intact) embryos, the parent embryos from which those nuclei are derived should fulfil the
conditions of this Appendix. Where nuclei derived from other types of donor cell (e.g.
post-hatching stage embryos, embryonic, fetal and adult cells, including
spermatozoa/spermatids for ICSI) are to be transplanted, the parent embryo, fetus or animal
from which those donor cells originate, and the methods whereby they are derived, including
cell culture, should comply with the relevant animal health standards recommended elsewhere
in this Terrestrial Code and in the Terrestrial Manual.
b) Where it is intended to transplant a nucleus into an oocyte (for ICSI), or into an enucleated
oocyte (for nuclear transfer), those oocytes should be collected, cultured and manipulated
according to the recommendations in this Appendix and/or in Appendix 3.3.2.
Article 3.3.3.4.
The importing country may request that tests2 be carried out on certain samples or that embryos are treated
to ensure that specified pathogenic organisms are absent.
1. Samples
Samples to be tested may include those referred to in Article 3.3.1.7. and/or in Article 3.3.2.4. Where
cells other that from zona pellucida-intact embryos (e.g. somatic or sperm cells) are used as donors
of nuclei for transplantation, then samples or cultures of those donor cells may also be tested.
2. Treatments
Treatments of embryos with the enzyme trypsin or other substances proven to inactivate or remove
pathogenic organisms, and which are harmless to the embryo, may be requested, but these also
should be applied prior to any micromanipulation, and according to the IETS Manual1.
Article 3.3.3.5.
Micromanipulated embryos should be stored, quarantined and transported according to the conditions
laid down in Article 3.3.1.8. or in points 4, 5, 6, 7 and 8 of Article 3.3.2.5. Veterinary certification
documents should identify all micromanipulations, where and when they were carried out.
2 If the samples mentioned above in point 1. of Article 3.3.3.4. are to be tested for pathogenic
agents, then the microbiological techniques in current use for those agents would be
appropriate.
Article 3.3.4.1.
Maintenance of laboratory animal colonies of specific genotypes requires intensive breeding management
within specialised premises. They may be kept in a gnotobiotic environment, in either a 'germfree' system
or a 'barrier' room (usually with defined flora), in a conventional colony, or under undefined conditions.
In both the germfree and barrier systems, the animals are raised in a controlled environment according to
protocols that attempt to eliminate potential sources of microbiological contamination. The primary
difference is that the barrier maintained animals have been inoculated with known (defined) microbes1
using a cocktail of non-pathogenic flora, whereas germfree animals are kept free from both pathogenic
and non-pathogenic microbes.
A second category is where laboratory animals are kept in closed, conventional colonies within which
known pathogens may exist. Here, less rigid colony management protocols are used to control potential
sources of contamination, but implementation of simple aseptic precautions (e.g. autoclaving of feed and
bedding) should allow animals to be maintained in a microbiologically defined system. Finally, laboratory
animals may live in environments with undefined microbiological conditions (e.g. non-restricted colonies,
free-ranging animals).
Disease testing and donor animal/embryo handling requirements can therefore be considered as being of
three distinct types, depending on the type of colony being dealt with, i.e. defined floral, conventional and
undefined. The health status of all colonies should be confirmed quarterly by bacteriological, virological,
parasitological, serological and immunohistochemical tests on pre-designated sentinel animals or other
representative animals of the colony (e.g. older breeding males which have sired multiple litters).
Article 3.3.4.2.
5. It is the responsibility of the chief embryologist (i.e. laboratory supervisor) to ensure that the
embryos are properly stored in sterile, sealed containers (e.g. ampules or straws). In addition, the
containers must be correctly identified using a standard format which includes embryo
species/genotype, cryopreservation date, number and stage of embryos, container number and
indication of any specialised procedure (e.g. in vitro fertilisation, micromanipulation) or condition
(e.g. germfree, microbiologically defined).
Article 3.3.4.3.
1. The veterinarian, certified in laboratory animal care or laboratory animal accredited, must ensure that
the required colony health profiling procedures are implemented, and the results are reviewed and
properly recorded before shipment of embryos. He/she is also responsible for confirming that
proper animal management/sanitation conditions have been maintained.
2. The veterinarian is responsible for certifying that the embryo handling procedures and laboratory
conditions were maintained in accordance with the IETS Manual2.
3. The veterinarian must supervise all quarantine practices to protect against unwanted contamination
and spread of disease, and to ensure that valid results are generated.
4. The veterinarian must authorise all embryo shipments, ensuring that the correct veterinary
certification documents and embryo collection records are completed and included in the shipments.
Article 3.3.4.4.
Sentinel animals in each donor colony should be subjected to routine monthly microbial screening.
Testing for specific pathogens is species dependent and will undoubtedly also be influenced by geographic
location. Recommendations regarding specific microbial agents to be tested for in mice, rats, cotton rats,
hamsters, guinea pigs, gerbils and rabbits have been published elsewhere3.
Article 3.3.4.5.
2. Conventional conditions
a) Animals maintained under these conditions generally represent closed colonies whose health
status is routinely profiled. They may have been exposed to various pathogens, resulting in the
isolation of infectious agents, positive antibody titres or even active clinical disease. However,
prior to embryo collection there should be familiarity with the pathogen(s) of particular concern
in the colony.
b) Reproductive tracts (uteri, oviducts and/or ovaries) should be removed at a separate site and
then taken into the embryo laboratory. These procedures should be performed by separate
technicians or, at the very minimum, their protective clothing should be changed between
locations. If the animals are to be handled in the laboratory, the tracts should be dissected out
within a biological safety cabinet. This will help protect against the possible shedding of
pathogens into the laboratory itself.
c) Once the reproductive tracts have been removed, embryo recovery should be performed under
aseptic conditions. Embryos must be inspected (>100x) for the presence of cracks in the zona
pellucida and only zona-intact embryos should be kept. They must then be washed using the
standard 10-step procedure, described in the IETS Manual2. This guideline could be waived in
the future if sufficient research evidence from embryo-pathogen interaction studies warranted
it.
d) Embryos derived from animals that have positive antibody titres or other evidence of specific
pathogens should only be transferred into a new colony via a quarantine system, using
microbiologically defined recipient females. As an additional safeguard, if there is any
uncertainty about the donor or disease status of the embryos, quarantining of recipients should
be applied. In certain situations where embryos might have been exposed to bacterial infection
(e.g. mycoplasma), they should be cultured in a medium containing an appropriate antibiotic for
24 h pre-freezing, or post-thawing and prior to transfer.
e) If the embryos were not handled in the recommended manner, this must be indicated on the
shipment records, and mandatory quarantining of the recipient dam and offspring should be
imposed by the recipient institution until their health status is confirmed. The recipient dam
should then be tested post-weaning for pathogens, and introduction of the progeny into the
colony should only take place if test results are satisfactory.
e) Cryopreserved embryos must be stored in the exporting laboratory until such time as the
necessary disease screening of tissues and fluids is completed. All embryos from these animals
must be transferred into a colony via a quarantine system, as discussed above. In addition to
testing the recipient dam, all offspring should be tested at 12 weeks of age and/or individuals
from successive generations should be tested before their introduction into breeding colonies
outside the quarantine facility.
Article 3.3.4.6.
1 Recommendations for the health monitoring of mouse, rat, hamster, guineapig and
rabbit breeding colonies.- Report of the Federation of European Laboratory Animal Science
Associations (FELASA), Working Group on Animal Health accepted by the FELASA Board of
Management, November 1992.
3 Schiewe M.C., Hollifield V.M., Kasbohm L.A. & Schmidt P.M. (1995) - Embryo importation
and cryobanking strategies for laboratory animals and wildlife species. Theriogenology, 43, 97-104.
Article 3.3.5.1.
In 2004, the Research Subcommittee of the International Embryo Transfer Society (IETS) Health and
Safety Advisory Committee again reviewed available research and field information on infectious diseases
which have been studied regarding the risk of their transmission via in vivo derived embryos. As a result of
this review, the IETS has categorised the following diseases and pathogenic agents into four categories.
Please note that this categorisation applies only to in vivo derived embryos.
The following methodology is used by the Research Subcommittee to categorise infectious diseases with
regard to the risk of their transmission:
1. Research procedures used to handle and process the embryos will comply with criteria that have
been set out by A. Bielanksi and W.C.D. Hare in Appendix A of the IETS Manual1.
2. The data used by the Subcommittee to categorise or re-categorise diseases will have been published
in peer-reviewed articles in reputable scientific journals. This is to ensure that scientific procedures
and results, as well as the interpretation of results, have undergone another level of review.
3. Decisions regarding disease categorisation are based on a consensus judgement which is taken
annually by the Subcommittee. The names of members of the Subcommittee who are present when
the decisions are made are recorded, as are the names of any others whose opinions were solicited in
the decision making process.
4. Questions considered in the decision-making process include the following:
a) What is the nature of the disease? For example, is the causal agent a uterine pathogen? Does it
occur in blood? Does it persist in blood? Do asymptomatic shedders occur? What is the
minimum infective dose?
b) Has the causal agent been found in the ovarian/oviductal/uterine (OOU) environment?
c) Is the causal agent’s presence in the OOU environment incidental or is it a consequence of the
pathogenesis of the disease?
d) Is the causal agent’s presence in the OOU environment consistent with obtaining viable
embryos?
e) Has the causal agent been found in flushing fluids?
f) Has the causal agent been found to penetrate or cross the intact zona pellucida (ZP)?
g) Has the causal agent been found to adhere to the ZP?
h) Is the causal agent removed by washing the embryo?
i) Will special treatments (e.g. with trypsin) remove or inactivate the causal agent?
j) How many embryos have been transferred with or without disease transmission?
k) What is the accumulated evidence for non-transmission of the disease by embryo transfer?
l) What evidence is there that the disease could be transmitted by embryo transfer?
m) Have negative (or positive) results been duplicated by the same or different investigators?
n) Has evidence been accumulated for different animal species as well as for a range of different
types and strains of the causal agent?
Article 3.3.5.2.
Category 1
Category 1 diseases or pathogenic agents are those for which sufficient evidence has accrued to show that
the risk of transmission is negligible provided that the embryos are properly handled between collection
and transfer according to the IETS Manual1.
The following diseases or pathogenic agents are in category 1:
- Bluetongue (cattle)
- Bovine spongiform encephalopathy (cattle)
- Brucella abortus (cattle)
- Enzootic bovine leukosis
- Foot and mouth disease (cattle)
- Infectious bovine rhinotracheitis: trypsin treatment required
- Aujeszky's disease (pseudorabies) (swine): trypsin treatment required.
Article 3.3.5.3.
Category 2
Category 2 diseases are those for which substantial evidence has accrued to show that the risk of
transmission is negligible provided that the embryos are properly handled between collection and transfer
according to the IETS Manual1, but for which additional transfers are required to verify existing data.
The following diseases are in category 2:
- Bluetongue (sheep)
- Classical swine fever (hog cholera)
- Scrapie (sheep).
Article 3.3.5.4.
Category 3
Category 3 diseases or pathogenic agents are those for which preliminary evidence indicates that the risk
of transmission is negligible provided that the embryos are properly handled between collection and
transfer according to the IETS Manual1, but for which additional in vitro and in vivo experimental data are
required to substantiate the preliminary findings.
The following diseases or pathogenic agents are in category 3:
- Bovine immunodeficiency virus
- Bovine spongiform encephalopathy (goats)
- Bovine viral diarrhea virus (cattle)
- Campylobacter fetus (sheep)
- Caprine arthritis/encephalitis
- Foot and mouth disease (swine, sheep and goats)
- Haemophilus somnus (cattle)
Article 3.3.5.5.
Category 4
Category 4 diseases or pathogenic agents are those for which studies have been done, or are in progress,
that indicate:
1. that no conclusions are yet possible with regard to the level of transmission risk; or
2. the risk of transmission via embryo transfer might not be negligible even if the embryos are properly
handled according to the IETS Manual1 between collection and transfer.
The following diseases or pathogenic agents are in category 4:
- African swine fever
- Akabane (cattle)
- Bovine anaplasmosis
- Bluetongue (goats)
- Border disease (sheep)
- Bovine herpesvirus-4
- Ovine epididymitis (Brucella ovis)
- Chlamydia psittaci (cattle, sheep)
- Enterovirus (cattle, swine)
- Escherichia coli 09:K99 (cattle)
- Leptospira borgpetersenii serovar hardjobovis (cattle)
- Leptospira sp. (swine)
- Maedi-visna (sheep)
- Mycobacterium bovis (cattle)
- Mycoplasma spp. (swine)
- Parainfluenza-3 virus (cattle)
- Parvovirus (swine)
- Scrapie (goats)
- Trichomonas foetus (cattle)
- Porcine circovirus (type 2) (pigs)
- Ureaplasma/Mycoplasma spp. (cattle, goats)
BIOSECURITY IN ESTABLISHMENTS
APPENDIX 3.4.1.
Article 3.4.1.1.
1. The choice of a suitably isolated geographical location, taking into account the direction of the
prevailing winds, facilitates hygiene and disease control. The establishment should be surrounded by a
security fence and a gateway to control traffic and access to the site. A sign indicating restricted entry
should be posted at the entrance.
2. Poultry breeding establishments should be single purpose - single species enterprises, and ideally an all
in all out single age group principle should be adopted whenever possible.
3. Where several flocks are maintained on one establishment, the individual flocks should be managed as
separate entities.
4. Buildings housing poultry or those used to store feed or eggs should be free of vermin and not
accessible to wild birds.
5. Poultry houses should be constructed so that all surfaces inside the buildings are of an impervious
smooth material so that cleaning and disinfection can be carried out adequately.
6. The area immediately surrounding the poultry houses should be free from vegetation and debris and
ideally this should consist of an area of concrete or other similar material. An exception to this would
be trees for heat control, with the exception of fruit trees which could be attractive to birds.
7. Domestic animals should not be permitted access to poultry houses.
8. Appropriate disease security precautions, which could include showering and changing facilities,
should be adopted for all visitors to the establishment and for all staff entering individual poultry
houses.
9. When a poultry house or establishment is depopulated, all manure should be removed from the
houses and effective cleaning and disinfection procedures applied. Bacteriological monitoring of the
efficacy of disinfection procedures is recommended. When necessary, rodent and insect control
procedures should also be carried out.
10. Repopulation of poultry houses or establishments should only be made from poultry flocks of known
high health status and which are regularly monitored for salmonella and other poultry pathogens.
11. All feed used in poultry houses and establishments should be monitored for salmonella prior to use.
The use of pelletised feeds or feeds subjected to other salmonella decontamination procedures is
recommended. Feed should be stored in clean closed containers.
12. The water supply to poultry houses should be of a satisfactory potable status.
13. Sick and dead birds should be removed from poultry houses as soon as possible and effective and
safe disposal procedures implemented.
14. Full records relating to mortality, disease diagnosis, treatments and vaccinations should be
maintained on an individual flock basis within the establishment. Such records should be readily
available for inspection.
Article 3.4.1.2.
1. The litter in the laying house should be kept dry and in good condition. The nest box litter should be
clean and adequate in quantity.
2. Eggs should be collected at frequent intervals of not less than twice per day and placed in clean
disinfected containers.
3. Dirty, broken, cracked, leaking and dented eggs should be collected in a separate container and
should not be used for hatching purposes.
4. The clean eggs should be sanitised as soon as possible after collection. The methods of sanitisation
are described in Article 3.4.1.7.
5. The sanitised eggs should be stored in a clean, dust free room used exclusively for this purpose and
kept at a temperature of 13-15°C (55°-60°F) and at a relative humidity of 70-80%.
6. The eggs should be transported to the hatchery in new or clean cases which have been fumigated or
sanitised with a liquid disinfectant (see Table I). The cleaning and disinfection of vehicles must be a
regular part of the hatchery routine.
Article 3.4.1.3.
1. The choice of a suitably isolated geographical location facilitates hygiene and disease control. The
building should be located as far as possible from other buildings housing livestock and poultry in
particular, and the direction of the prevailing winds should be taken into consideration.
2. The design of the hatchery should be based on suitable work flow and air circulation principles. It
should be constructed so that there is a one way flow for the movement of eggs and chicks, and the
air flow also follows this same one way direction.
3. The hatchery buildings should include physical separation of all work areas. If possible, separate
ventilation should be provided for these work areas, namely, the rooms for:
a) egg receiving and egg storage;
b) egg traying;
c) fumigation;
d) setting or initial incubation;
e) hatching;
f) sorting, sexing and placing chicks in boxes;
g) material storage, including egg and chick boxes, egg flats, box pads, chemicals and other items;
h) facilities for washing equipment and disposal of waste;
Article 3.4.1.4.
1. The area adjacent to the hatchery buildings should be surrounded by a security fence and a gateway
to control all traffic.
2. Wild birds, domestic and wild animals must be excluded from the hatchery area. When necessary, a
specific programme for fly control should be implemented.
3. The hatchery area should be maintained free from all hatchery waste, garbage of all kinds and
discarded equipment.
4. Approved disposal methods and adequate drainage must be available.
5. All hatchery equipment, tables and horizontal surfaces in rooms must be promptly and thoroughly
vacuumed, cleaned, washed, scrubbed, rinsed with clean water and finally disinfected with an
approved disinfectant.
Article 3.4.1.5.
1. Clean coveralls or overalls, hats and footwear must be provided for all personnel and visitors
entering the establishment or the hatchery.
2. A disinfectant foot-bath for footwear is necessary and the disinfectant solution should be changed
frequently. Washing the hands in disinfectant solution or with soap and water should be required.
3. Personnel and visitors should have no direct contact with other poultry or poultry products.
Article 3.4.1.6.
1. Egg handlers in the hatchery should wash their hands with soap and water and change to clean outer
garments before handling hatching eggs received from the poultry farm.
2. Chick sexers and chick handlers must wash and disinfect their hands and change into clean
protective clothing and boots before commencing work and between different lots of chicks.
3. Day-old chicks or other poultry must be delivered or distributed in new chick boxes; or in used
boxes made of suitable material which have been thoroughly cleaned and disinfected or fumigated.
4. The chicks should be delivered directly from the hatchery by personnel wearing clean, disinfected
outer clothing. Outer clothing should be changed or disinfected between each delivery.
5. The delivery truck must be cleaned, and disinfected before loading each consignment of chicks.
Article 3.4.1.7.
Sanitisation means:
a) fumigation with formaldehyde, or
b) spraying with or immersion in an egg shell disinfectant in accordance with the manufacturers
instructions, or
c) made hygienic by another method approved by the Veterinary Authorities.
Formaldehyde gas has been used for many years for the disinfection of hatching eggs and hatchery
equipment. As a fumigant, formaldehyde gas has proved to be a very effective means of destroying
micro-organisms on eggs, egg cases, chick boxes, hatching machines and other hatchery equipment,
provided these items have been subjected to preliminary cleaning. When the correct mixture of formalin
and potassium permanganate is used, a dry brown powder will remain after the reaction is completed.
At the present time, there is lack of uniform opinion on the optimum concentration of formaldehyde
required for the sanitisation of eggs and hatchery equipment. In general, three levels of concentration
have been used. Also, two methods of use have been adopted.
1. Method 1
a) Concentration A
53 ml formalin (37.5%) and 35 g potassium permanganate per m³ of space.
This can be expressed as:
5.25 oz by volume (148.5 ml) formalin (37.5%) and 3.5 oz by weight (98 g) potassium
permanganate per 100 ft³ (2.8 m³) of space.
b) Concentration B
43 ml formalin (37.5%) and 21 g potassium permanganate per m³ of space.
This can be expressed as:
4 oz by volume (120 ml) formalin (37.5%) and 2 oz (60 g) potassium permanganate per 100 ft³
(2.8 m³) of space.
c) Concentration C
45 ml formalin (40%) and 30 g potassium permanganate per m³ of space.
This can be expressed as:
4.5 oz by volume formalin and 3 oz potassium permanganate per 100 ft³.
d) Procedure
Fumigation of hatching eggs and equipment should be carried out in a special chamber or in a
room or building constructed of impermeable material which can be made as airtight as
possible. A fan is necessary to circulate the gas during fumigation and to expel it after
fumigation is completed.
The total volume of the room is determined accurately from the internal measurements. The
space occupied by trays, or eggs, or articles to be fumigated, is to be disregarded. The quantities
of materials required are based on the total volume.
Place in the centre of the floor, one or preferably several large metal basins, metal trays or
containers of earthenware, enamelware, asbestos or other non-inflammable material.
PLASTIC OR POLYETHYLEN CONTAINERS ARE NOT TO BE USED due to the
heat generated by the chemical reaction. To avoid possible fire hazards, the containers should
slope outwards. Also, the containers must be large enough so that the two chemicals occupy no
more than one quarter of the volume of the container. Preferably, the container should have a
capacity of at least 10 times the volume of the total ingredients.
The eggs should be placed on wire racks, in wire baskets or on cup-type egg flats stacked in a
manner that will permit air circulation and exposure to the formaldehyde gas.
An electric or hot water heater should be available in the chamber to maintain the temperature
at 75°-100°F (24°-38°C). Water pans or other equipment should be available to provide a
relative humidity of 60-80%.
Place required amount of potassium permanganate into the containers BEFORE adding the
formalin.
Pour the required amount of formalin onto the potassium permanganate in the containers.
Leave the chamber as quickly as possible and close the door. Some operators may wish to use a
gas mask when pouring the formalin into the containers.
The door of the chamber should be securely closed and permanently labelled to prevent
accidental opening.
The fans should be operated to circulate the formaldehyde and the fumigation time should be
20 minutes.
After 20 minutes, the gas should be expelled through a controlled vent leading to the outside of
the building.
The door may be opened to facilitate expelling the formaldehyde to the outside.
2. Method 2
An alternative method to the above is to use formaldehyde gas produced by the evaporation of
paraformaldehyde. Proprietary preparations are available and the operation is carried out by placing
the requisite amount of powder on a pre-heated hot plate.
In this method it is necessary to ensure that the relative humidity of the chamber is sufficiently high
(60-80%).
Ten g paraformaldehyde powder or pellet is used per m³ of space.
3. Warning
In carrying out fumigation, the following points should be borne in mind:
a) Caution is necessary when formalin and potassium permanganate are mixed together in large
amounts because of the risk of personal injury and fire through careless use. Formaldehyde gas
causes irritation to the eyes and nose of the operator and the use of a gas mask is advised.
b) Effective fumigation depends on optimum conditions of temperature and humidity.
Formaldehyde gas rapidly loses its efficiency at low temperatures or in a very dry atmosphere.
Article 3.4.1.8.
After fumigation for 20 minutes, the ventilators should be opened to the normal operating position
in order to release the gas.
Warning
Do not fumigate eggs that have been incubated for 24 to 96 hours, as this can result in embryo
mortality.
This is a common practice in certain areas and under certain conditions. The eggs should be
fumigated after being transferred from the setting machine to the hatching machine and before 10%
of the chicks have begun to break the shell. After transfer of the eggs, the hatching machines are
permitted to return to normal operating temperatures and humidity. The ventilators are closed and
fumigation is conducted with the fans running. In some countries, the standard amounts of formalin
(53 ml) and potassium permanganate (35 g) per m³ are used. Fumigation time is 20 minutes. In other
countries, 0.8 cc formalin (37.5%) is added to 0.4 g potassium permanganate for each ft³ of space; or
25 ml formalin to 12.5 g potassium permanganate per m³. Fumigation time is 20 minutes.
Following removal of all the eggs or the chicks and the subsequent cleaning and disinfection of the
empty machine, the disinfected egg trays are replaced and the machine prepared for the next batch of
incubating eggs.
The doors and ventilators should be closed and the temperature and humidity returned to normal
operating levels. Fumigation time should be at least 3 hours or preferably overnight, using the
standard amounts of formalin and potassium permanganate (Concentration A).
The machines should be well ventilated before use to remove any residual fumigant.
Warning
The above fumigation procedure applies to a machine in which there are no hatching eggs. Eggs and
chicks cannot be fumigated using the above fumigation time.
This can be achieved with a 25% solution of ammonium hydroxide using an amount not more than
one half the volume of formalin used. The ammonia can be spread on the floor of the machine and
the doors closed quickly.
Article 3.4.1.9.
1. At the present time the only method for monitoring poultry breeding flocks and hatcheries for
salmonella is by means of bacteriological examination of samples obtained from these establishments.
2. Samples for bacteriological monitoring of poultry flocks are obtained in the case of rearing flocks from
the premises in which the birds are housed or in the case of adult laying birds either from the
premises in which the birds are housed or from the hatchery to which the hatching eggs from that
flock are consigned.
3. The samples to be taken are:
a) on the premises in which birds are housed - fresh faeces (each sample at least 1 gram), dead or
culled birds, or in the case of day-old birds the chick box liners;
b) at the hatchery - meconium, dead in shell and culled chicks.
Additionally, it is recommended that environmental samples such as drag swabs, litter, feather, down
and dust, are also taken in both the premises and the hatchery at a similar frequency. Where the
laying flock is sampled only on the premises, environmental sampling of the hatchery is required.
4. The total number of samples to be taken on each occasion is shown in Table 2 and is based on the
random statistical sample required to give a probability of 95% to detect one positive sample given
that infection is present in the population at a level of 5% or greater.
5. All samples should be selected at random to represent the house or in the case of samples taken at
the hatchery to represent the hatching eggs from that poultry flock.
a) Rearing flocks
Where birds are moved from the rearing premises other than direct to laying accomodation, a
further sample should be taken 3 weeks before such movement.
The laying flocks should be sampled at least at monthly intervals during the laying period.
7. All samples should be fully marked and identified as to the date of sampling and the flock to which
the samples relate.
8. Samples should be stored in a refrigerator at between 1°C and 4°C until they are dispatched to the
laboratory (not more than 5 days).
9. All samples should be examined in a laboratory authorised for that purpose by the Veterinary
Authorities.
Article 3.4.2.1.
Article 3.4.2.2.
Permanent official sanitary surveillance of apiaries should be under the authority of the Veterinary
Administration and should be performed either by representatives of this Administration or by
representatives of an approved organisation, with the possible assistance of bee-keepers specially trained
to qualify as ‘health inspectors and advisers’.
The official surveillance service thus established should be entrusted with the following tasks:
1. visit apiaries:
a) annual visits during the most appropriate periods for the detection of diseases;
b) unexpected visits to apiaries where breeding or transport operations are carried out for trade or
transfer to other regions, or any other purpose whereby diseases could be spread, as well as to
apiaries located in the vicinity;
c) special visits for sanitary surveillance to sectors where breeding apiaries have been approved for
export purposes;
2. collect the samples required for the diagnosis of contagious diseases and despatch them to an official
laboratory; the results of laboratory examinations must be communicated within the shortest delay to
the Veterinary Authority;
3. apply hygiene measures, comprising, in particular, treatment of colonies of bees, as well as disinfection
of the equipment and possibly the destruction of affected or suspect colonies and of the
contaminated equipment so as to ensure rapid eradication of any outbreak of a contagious disease.
Article 3.4.2.3.
b) no case of any other contagious disease of bees included in this Terrestrial Code has been
reported for at least the past 8 months within a radius of 5 kilometres;
2. have received, for at least the past 2 years, visits by a health inspector and adviser, carried out at least
3 times a year (in spring, during the breeding period and in autumn), for the systematic examination
of the hives containing bees and of all the apicultural equipment, and for the collection of samples to
be sent to an official laboratory.
Bee-keepers must:
3. immediately notify the Veterinary Authority of any suspicion of a contagious disease of bees in the
breeding apiary and in other apiaries in the vicinity;
4. not introduce into the apiary any bee (including larval stages) or apicultural material or product
originating from another apiary unless health control has been previously performed by the
Veterinary Authority;
5. apply special breeding and despatch techniques to ensure protection against any outside
contamination, especially for the breeding and sending of queen-bees and accompanying bees and to
enable retesting in the importing country;
6. collect at least every 10 days, during the breeding and despatch period, samples from breeding
material, brood-combs, queen-bees and bees (including possibly separately raised accompanying
bees), to be sent to an official laboratory.
Article 3.4.2.4.
Veterinary Administrations of exporting countries are requested to regulate the use of products and means for
sanitation and disinfection of apicultural equipment in their own country, taking into account the following
guidelines.
1. Any apicultural equipment kept in an establishment which has been recognised as being affected with a
contagious disease of bees shall be subjected to sanitary measures ensuring the elimination of
pathogens.
2. In all cases, these measures comprise the initial cleaning and scraping of the equipment, followed by
sanitation or disinfection depending on the disease concerned.
3. The kind of equipment (hives, small hives, combs, extractor, small equipment, appliances for
handling or storage) shall also be taken into account in the choice of procedures to be applied.
5. The products and means used for sanitation and disinfection shall be recognised as being effective by
the Veterinary Authority. They shall be used in such a manner as to exclude any risk of contaminating
the equipment which could eventually affect the health of bees or adulterate the products of the hive.
6. When these procedures are not performed, the products shall be kept away from the bees and any
contact with apicultural equipment and products must be prevented.
7. Waste water from the cleaning, sanitation and disinfection of apicultural equipment shall be kept away
from the bees at all times and disposed of in a sewer or in an unused well.
Article 3.4.2.5.
This Certificate covers hives containing bees, swarms, consignments of bees (worker bees or drones),
queen bees (with accompanying bees), brood-combs, royal cells, etc.
This document shall be prepared in accordance with the model contained in Appendix 4.1.9.
Article 3.4.3.1.
The use of microchip implanters, needles and syringes in a wide range of routine veterinary procedures
relative to identification, blood sampling, vaccination and the injection of medicinal products or devices is
now commonplace.
Unsterilised equipment and the use of opened vials of vaccine and medicinal products for different herds
should be unacceptable professionally.
The use of unsterilised and contaminated equipment (microchip implanters, needles, syringes, etc.) or
products is of special importance for different herds and animals to be exported. It is a requirement,
particularly applicable for animals to be exported, that care is taken to ensure the sterility of all equipment
and veterinary products associated with the conditions of the export certificate.
These precautions have particular importance for teams of veterinarians and para-veterinarians.
The range of organisms capable of being transmitted includes viruses, bacteria and protozoa. The list of
infectious agents transmissible in the context of this Appendix continues to expand for all species of
animals.
QUARANTINE RECOMMENDATIONS
APPENDIX 3.5.1.
Article 3.5.1.1.
General Principles
The present Appendix defines the standards to be followed in the case of a non-human primate being
imported directly from a country within the natural range of the animal's species concerned, and where
only limited health guarantees can be given, or in cases where Article 2.10.1.2., last paragraph, applies.
Quarantine programmes are designed to both facilitate the detection of communicable diseases and to
make accurate assessments of the overall health status of individuals and/or groups entering a new
population. Prudence dictates that for public health and safety the infectious disease status of all incoming
animals is considered at best uncertain.
Quarantines are defined by their duration and by the activities and procedures practised to assess health
status.
The minimal duration of the quarantine period, as defined by Articles 2.10.1.4. , 2.10.1.5. and 2.10.1.6. of
Chapter 2.10.1., may be extended until any adverse events during the quarantine period are fully
investigated and resolved, and no evidence of transmission of infectious agents within the quarantined
group exists.
Quarantine activities and procedures should be directed towards defining as much as possible the health
status of quarantined animals, while protecting persons and other animals from inadvertent exposure to
communicable agents and providing for the health and well-being of quarantined animals. Therefore
quarantine practices should:
1. encompass measures which effectively isolate animals or groups of animals thereby preventing the
spread of communicable diseases;
Article 3.5.1.2.
Management policies
Management should restrict access to the quarantine facility to authorised and essential personnel, who do
not pose a communicable disease risk to non-human primates.
Management should instruct personnel about the potential risks of working in the quarantine facility, and
the need to conduct all activities in a safe manner. There should be periodic retraining of personnel.
Management may prohibit persons who may be at increased risk of acquiring infections or for whom an
infection might be unusually hazardous from the quarantine facility. Management may require other
personnel health promotion activities, such as those mentioned in point 5. of Article 2.10.1.7.
Article 3.5.1.3.
1. The construction or location, and the operation of the quarantine facility should provide for strict
segregation and isolation of quarantined animals from other animals and from personnel not
essential to the operation of the quarantine.
2. Methods to attain this isolation include:
a) The use of security measures such as physical barriers and procedural access control systems.
b) As part of the security system, a hazard warning sign should be posted at the entrance to the
quarantine stating that exposure to infectious diseases may occur in the quarantine. The names
and telephone numbers of contact persons responsible for the quarantine area should be
provided, and all special requirements for entering the quarantine area should be listed.
c) The implementation of an effective rodent, feral animal, and insect control programme, which
does not pose a health risk to the quarantined animals.
d) The complete physical separation of groups of quarantined animals from other groups of
quarantined animals to prevent exposure to and the introduction of infectious agents from one
group to another during the quarantine period. As a rule, only animals arriving in one shipment
from the same exporter should be grouped together. Animals may not be exchanged between
groups or groups mixed during the quarantine period, unless the newly formed group restarts
the entire quarantine process.
3. The quarantine facility should be designed to allow for the secure holding of quarantined animals and
to allow for the safe, easy and efficient cleaning and decontamination of the animal holding area and
the access area during and after use.
a) A quarantine facility should consist of a minimum of two discrete areas physically separated
from the outside and from each other, including an access area where clothes, footwear and
protective articles are changed, and where locker, hand-washing and, if possible, showering
facilities are provided.
Procedures should be in place to prevent the cross-contamination of clothes and footwear worn
outside the quarantine facility from potentially contaminated protective clothing worn inside the
animal holding area.
b) Animal holding room wall, floor, and ceiling surfaces should be water resistant to facilitate
cleaning and disinfecting. Any holes or penetrations in these surfaces should be sealed or be
capable of being sealed to facilitate fumigation or space decontamination. Doors to animal
rooms should open inward, and should always be kept closed when animals are present. Any
windows should be closed and sealed, unless the facility is sufficiently separated (distance,
fences, other means of separation) from non-quarantined area.
c) In facilities that are operated with the windows closed and sealed, a ventilation system should be
operated and monitored in such a manner to assure the provision of an optimal isolation of
these animals, while also providing for their health and comfort. The direction of the airflow in
the quarantine facility should be inward from the outside of the quarantine facility, to quarantine
access areas, to animal holding rooms. Air exhausted or re-circulated within the facility must be
filtered. In addition, exhaust air should be dispersed away from the building and other occupied
areas. Heating, ventilating, and air-conditioning systems should be designed so that their
operation can be continued, even at reduced capacity in the event of electrical or other support
system failure.
d) If floor drains are present, their drain traps should always be filled with water or a suitable
disinfectant.
e) A hand washing sink should be available in the animal holding room for personnel usage.
f) Adequate equipment and space should be available both in the animal holding area and in the
quarantine facility in general for the adequate decontamination and the proper disposal or
processing and storing of all supplies and equipment used in the quarantine.
Article 3.5.1.4.
1. Eating, drinking, smoking and storing of food for human use should not be permitted in the
quarantine facility.
2. All staff entering the quarantine should wear (preferably disposable) protective clothing and devices.
3. Protective clothing, gloves, and mucus membrane protection should not be used in more than one
quarantine animal holding room. This may require the changing of protective clothing by staff as
they go between rooms in the performance of their duties.
4. Foot or shoe baths should be provided and used at the exits of the animal holding area and of each
animal holding room. They should be changed often enough to remain fresh and free of organic
matter.
5. Showering after contact with non-human primates, their body waste or secretions or at a minimum
before leaving the quarantine facility is highly recommended.
6. Intermittent and frequent hand washing while working in the quarantine facility is highly
recommended. This is especially important as protective gloves may become inadvertently torn or
ruptured.
7. Baseline serum samples from quarantine personnel should be collected and stored. Additional serum
samples may be collected periodically, as an aid to epidemiological investigations.
8. Management should encourage quarantine staff developing signs of illness to seek medical attention.
Article 3.5.1.5.
1. If a quarantine facility maintains more than one animal holding room, husbandry practices should be
designed so as to minimise the risk of transmission of zoonotic diseases between rooms. In
particular, there should be separate cleaning tools and other animal care equipment for each room.
All cages and other non-disposable equipment should be decontaminated when removed from the
room.
2. All husbandry and animal care procedures should be carefully performed to minimise the creation of
aerosols and limit the spread of potentially infectious materials, while also providing for the
appropriate care and well-being of the animals concerned.
Waste, uneaten food, and other potentially contaminated materials leaving the quarantine area must
be suitably contained, while being transported to a site of physical or chemical decontamination, or
incineration.
3. Work surfaces should always be decontaminated after use or whenever soiled. Equipment should not
be stored on the floor.
4. Care should be taken to avoid scratches, bites or other injuries from non-human primates through
anaesthesia, tranquillisation or physical restraint of the animals during handling. Physical restraint
should only be performed by personnel knowledgeable and experienced in handling non-human
primates, and it should never be done by persons working alone.
5. Caution must be used to prevent injury to personnel or the spread of infectious materials between
animals through the use of potentially contaminated needles, scalpels, or other sharp instruments,
particularly during the disposal of these items. Only single use disposable syringes and needles,
scalpel blades, and other sharp items should be used. They should never be recapped, bent, broken
or otherwise manipulated by hand, and they should be discarded into puncture-resistant containers
kept as close to the work site as practical. Containers should be decontaminated before disposal.
6. If multiple-dose vials of materials or medications are used, care must be taken to avoid
contamination of such vials and their contents between uses.
7. Dead animals should be removed from their animal holding room and taken to a dedicated necropsy
room in a sealed, impervious, leakproof container or bag.
8. Responsible quarantine officials should immediately notify the Veterinary Administration of any
severe and/or unusual illnesses and deaths occurring in quarantined non-human primates.
9. After animals are removed from quarantine, a thorough decontamination of the animal holding
room is necessary whether there is a history of communicable disease presence in the room or not.
APPENDIX 3.6.1.
GENERAL RECOMMENDATIONS ON
DISINFECTION AND DISINSECTISATION
Article 3.6.1.1.
Veterinary Administrations are requested to draw up regulations in their respective countries concerning
the use of disinfectants and insecticides on the basis of the principles described below:
1. The choice of disinfectants and of procedures for disinfection should be made taking into account the
causal agents of infection and the nature of the premises, vehicles and objects which are to be treated.
2. Disinfectants and insecticides should be authorised only after thorough tests have been carried out
under field condition.
3. The following should be considered:
a) few universal disinfectants exist;
b) whereas hypochlorite, which is very often used, may be regarded as a universal disinfectant, its
effectiveness is diminished by prolonged storage and it is therefore necessary to check its
activity before use; a concentration of 0.5% active chlorine appears necessary for satisfactory
disinfection;
c) foot and mouth disease virus is easily destroyed by a high or low pH but the disinfectants used
may be caustic or corrosive in concentrated form;
d) tubercle bacillus is very resistant to disinfectants and a high concentration is required to destroy
the organism, as well as prolonged action;
e) no matter what substances are used, disinfection techniques should comprise the following:
i) thorough soaking of bedding and litter as well as faecal matter with the disinfectant;
ii) washing and cleaning by careful brushing and scrubbing of the ground, floors and walls;
iii) then further washing with the disinfectant;
iv) washing and disinfecting the outside of vehicles; these procedures will be carried out, if
possible, with liquids applied under pressure and the washing, disinfecting or destroying of
articles used for tying up the animals (ropes, reins, etc.) should not be omitted.
Article 3.6.2.1.
Meat
For the inactivation of viruses present in meat, one of the following procedures should be used:
1. Canning
Meat is subjected to heat treatment in a hermetically sealed container to reach an internal core
temperature of at least 70°C for a minimum of 30 minutes or to any equivalent treatment which has
been demonstrated to inactivate the FMD virus.
2. Thorough cooking
Meat, previously deboned and defatted, shall be subjected to heating so that an internal temperature
of 70°C or greater is maintained for a minimum of 30 minutes.
After cooking, it shall be packed and handled in such a way that it cannot be exposed to a source of
virus.
3. Drying after salting
When rigor mortis is complete, the meat must be deboned, salted with cooking salt (NaCl) and
completely dried. It must not deteriorate at ambient temperature.
‘Drying’ is defined in terms of the ratio between water and protein which must not be greater than
2.25:1.
Article 3.6.2.2.
For the inactivation of viruses present in wool and hair for industrial use, one of the following procedures
should be used:
1. industrial washing, which consists of the immersion of the wool in a series of baths of water, soap
and sodium hydroxyde (soda) or potassium hydroxyde (potash);
2. chemical depilation by means of slaked lime or sodium sulphide;
3. fumigation in formaldehyde in a hermetically sealed chamber for at least 24 hours. The most
practical method is to place potassium permanganate in containers (which must NOT be made of
plastic or polyethylene) and add commercial formalin; the amounts of formalin and potassium
permanganate are respectively 53 ml and 35 g per cubic metre of the chamber;
4. industrial scouring which consists of the immersion of wool in a water-soluble detergent held at
60-70°C;
5. storage of wool at 18°C for 4 weeks, or 4°C for 4 months, or 37°C for 8 days.
Article 3.6.2.3.
Bristles
For the inactivation of viruses present in bristles for industrial use, one of the following procedures
should be used:
Article 3.6.2.4.
For the inactivation of viruses present in raw hides and skins for industrial use, the following procedure
should be used: salting for at least 28 days in sea salt containing 2% sodium carbonate.
Article 3.6.2.5.
For the inactivation of viruses present in milk and cream for human consumption, one of the following
procedures should be used:
1. a sterilisation process applying a minimum temperature of 132°C for at least one second (ultra-high
temperature [UHT]), or
2. if the milk has a pH less than 7.0, a sterilisation process applying a minimum temperature of 72°C
for at least 15 seconds (high temperature - short time pasteurisation [HTST]), or
3. if the milk has a pH of 7.0 or over, the HTST process applied twice.
Article 3.6.2.6.
For the inactivation of viruses present in milk for animal consumption, one of the following procedures
should be used:
2. HTST combined with another physical treatment, e.g. maintaining a pH 6 for at least one hour or
additional heating to at least 72°C combined with dessication;
Article 3.6.2.7.
Skins and trophies from wild animals susceptible to foot and mouth disease
For the inactivation of viruses present in skins and trophies from wild animals susceptible to FMD, one
of the following procedures should be used prior to complete taxidermal treatment:
1. boiling in water for an appropriate time so as to ensure that any matter other than bone, horns,
hooves, claws, antlers or teeth is removed;
2. gamma irradiation at a dose of at least 20 kiloGray at room temperature (20°C or higher);
3. soaking, with agitation, in a 4% (w/v) solution of washing soda (sodium carbonate - Na2CO3)
maintained at pH 11.5 or above for at least 48 hours;
4. soaking, with agitation, in a formic acid solution (100 kg salt [NaCl] and 12 kg formic acid per 1,000
litres water) maintained at below pH 3.0 for at least 48 hours; wetting and dressing agents may be
added;
5. in the case of raw hides, salting for at least 28 days with sea salt containing 2% washing soda (sodium
carbonate - Na2CO3).
Article 3.6.3.1.
Meat-and-bone meal
The following procedure should be used to reduce the infectivity of any transmissible spongiform
encephalopathy agents which may be present during the production of meat-and-bone meal containing
ruminant proteins
1. The raw material should be reduced to a maximum particle size of 50 mm before heating.
2. The raw material should be heated under saturated steam conditions to a temperature of not less
than 133°C for a minimum of 20 minutes at an absolute pressure of 3 bar.
Article 3.6.4.1.
Swill
For the inactivation of classical swine fever (CSF) virus likely to be present in swill, one of the following
procedures should be used:
1. the swill should be maintained at a temperature of at least 90°C for at least 60 minutes, with
continuous stirring, or
2. the swill should be maintained at a temperature of at least 121°C for at least 10 minutes at an
absolute pressure of 3 bar.
Article 3.6.4.2.
Meat
For the inactivation of viruses present in meat, one of the following procedures should be used:
1. Heat treatment
Meat shall be subjected to one of the following treatments:
a) heat treatment in a hermetically sealed container with a Fo value of 3.00 or more;
b) heat treatment at a minimum temperature of 70°C, which must be reached throughout the
meat.
2. Natural fermentation and maturation
The meat should be subjected to a treatment consisting of natural fermentation and maturation
having the following characteristics:
a) an aw value of not more than 0.93, or
b) a pH value of not more than 6.0.
Hams should be subjected to a natural fermentation and maturation process for at least 190 days and
loins for 140 days.
3. Dry cured pork meat
a) Italian style hams with bone-in should be cured with salt and dried for a minimum of 313 days.
b) Spanish style pork meat with bone-in should be cured with salt and dried for a minimum of 252
days for Iberian hams, 140 days for Iberian shoulders, 126 days for Iberian loin, and 140 days
for Serrano hams.
ANIMAL WELFARE
APPENDIX 3.7.1.
Article 3.7.1.1.
1. That there is a critical relationship between animal health and animal welfare.
2. That the internationally recognised ‘five freedoms’ (freedom from hunger, thirst and malnutrition;
freedom from fear and distress; freedom from physical and thermal discomfort; freedom from pain,
injury and disease; and freedom to express normal patterns of behaviour) provide valuable guidance
in animal welfare.
3. That the internationally recognised ‘three Rs’ (reduction in numbers of animals, refinement of
experimental methods and replacement of animals with non-animal techniques) provide valuable
guidance for the use of animals in science.
4. That the scientific assessment of animal welfare involves diverse elements which need to be
considered together, and that selecting and weighing these elements often involves value-based
assumptions which should be made as explicit as possible.
5. That the use of animals in agriculture and science, and for companionship, recreation and
entertainment, makes a major contribution to the wellbeing of people.
6. That the use of animals carries with it an ethical responsibility to ensure the welfare of such animals
to the greatest extent practicable.
7. That improvements in farm animal welfare can often improve productivity and food safety, and
hence lead to economic benefits.
8. That equivalent outcomes (performance criteria), rather than identical systems (design criteria), be
the basis for comparison of animal welfare standards and guidelines.
Article 3.7.1.2.
1. Welfare is a broad term which includes the many elements that contribute to an animal’s quality of
life, including those referred to in the ‘five freedoms’ listed above.
2. The scientific assessment of animal welfare has progressed rapidly in recent years and forms the basis
of these guidelines.
3. Some measures of animal welfare involve assessing the degree of impaired functioning associated
with injury, disease, and malnutrition. Other measures provide information on animals’ needs and
affective states such as hunger, pain and fear, often by measuring the strength of animals’
preferences, motivations and aversions. Others assess the physiological, behavioural and
immunological changes or effects that animals show in response to various challenges.
4. Such measures can lead to criteria and indicators that help to evaluate how different methods of
managing animals influence their welfare.
Article 3.7.2.1.
Responsibilities
Once the decision to transport animals by sea has been made, the welfare of animals during their
transport is paramount and is the joint responsibility of all people involved. These guidelines may also be
applied to the transport of animals by water within a country.
The management of animals at post-discharge facilities is outside the scope of this Appendix.
The roles of each of those responsible are defined below:
1. Exporters, owners of animals and managers of facilities are jointly responsible for the general health
of the animals and their fitness for the journey.
2. The exporter has overall responsibility for the organisation, carrying out and completion of the
journey, regardless of whether duties are subcontracted to other parties during transport. The
exporter is also responsible for ensuring that equipment and medication are provided as appropriate
for the species and journey, and for the presence during the journey of at least one animal handler1
competent for the species being transported. The exporter is also responsible for ensuring
compliance of the animals with any required veterinary certification and, in the case of animals for
export, any other requirements of the importing country and the exporting country.
3. Business or buying/selling agents have a joint responsibility with owners for the selection of animals
that are fit to travel. They have a joint responsibility with masters of vessels and managers of facilities
at the start and at the end of the journey for the availability of suitable facilities for the assembly,
loading, transport, unloading and holding of animals, and for emergencies.
4. Animal handlers are responsible for the humane handling and care of animals, especially during
loading and unloading. To carry out these responsibilities, they should have the authority to take
prompt action.
5. The exporter, the shipping company and the master of the vessel are jointly responsible for planning
the journey to ensure the care of the animals, including:
a) choosing appropriate vessels and ensuring that competent animal handlers are available for
loading and caring for animals throughout the journey;
b) developing and keeping up to date contingency plans to address emergencies (including adverse
weather conditions) and minimise stress during transport;
c) correct loading of the ship, regular inspections during the journey and for appropriate responses
to problems arising;
d) disposal of carcasses according to international law.
6. To carry out these responsibilities, the people involved should be competent regarding transport
regulations, equipment usage, humane handling and the care of animals.
7. Managers of facilities during loading of the animals are responsible for:
a) providing suitable premises for loading the animals;
b) providing competent animal handlers to load the animals in a manner that causes minimum
stress and injury;
c) providing appropriate facilities for emergencies;
d) providing facilities and veterinarians or competent animal handlers capable of killing animals
humanely when required.
8. Managers of facilities at the end of the journey are responsible for:
a) providing suitable facilities for unloading the animals onto transport vehicles for immediate
movement or securely holding the animals in lairage, with shelter, water and feed, when
required, for transit;
b) providing competent animal handlers to unload the animals with minimum stress and injury;
c) minimising the opportunities for disease transmission while the animals are in the facilities;
d) providing appropriate facilities for emergencies;
e) providing facilities and veterinarians or competent animal handlers capable of killing animals
humanely when required.
9. The responsibilities of the Competent Authority of the exporting country include:
a) establishing minimum standards for animal welfare, including requirements for inspection of
animals before and during their travel, and for certification and record keeping;
b) approving facilities, containers, vehicles/vessels for the holding and transport of animals;
c) setting competence standards for animal handlers and managers;
d) ensuring that the vessel transporting animals meets the required standards, including those of
the importing country;
e) implementation of the standards, including through accreditation of / interaction with other
organisations and Competent Authorities;
f) monitoring and evaluating health and welfare performance, including the use of any veterinary
medications.
10. The responsibilities of the Competent Authority of the importing country include:
a) establishing minimum standards for animal welfare, including requirements for inspection of
animals after their travel, and for certification and record keeping;
b) approving facilities, containers and vehicles for the unloading, holding and transport of animals;
c) setting competence standards for animal handlers and managers;
d) implementation of the standards, including through accreditation of / interaction with other
organisations and Competent Authorities;
e) ensuring that the exporting country is aware of the required standards for the vessel transporting
the animals;
f) monitoring and evaluating health and welfare performance, including the use of any veterinary
medications.
11. Veterinarians are responsible for the humane handling and treatment of animals during the journey.
To carry out these responsibilities, they should have the authority to act and report independently.
The veterinarian should meet with the Master, Chief Officer and the senior animal handler on a daily
basis.
Article 3.7.2.2.
Competence
1. All people handling animals or who are otherwise responsible for animals during journeys, should be
competent according to their responsibilities listed in Article 3.7.2.1. Competence in areas other than
animal welfare would need to be addressed separately. Competence may be gained through formal
training and/or practical experience.
2. This competence should be demonstrated through a current certificate in one of the OIE official
languages from an independent body accredited by a Competent Authority.
3. Assessment of competence for animal handlers should at a minimum address knowledge, and ability
to apply that knowledge, in the following areas:
c) animal behaviour, general signs of disease, and indicators of poor animal welfare such as stress,
pain and fatigue, and their alleviation;
f) appropriate methods of animal handling during transport and associated activities such as
assembling, loading, and unloading;
h) species-specific aspects of animal handling and care, including feeding, watering and inspection;
4. Assessment of competence for exporters should at a minimum address knowledge, and ability to
apply that knowledge, in the following areas:
a) planning a journey, including appropriate space allowances, and feed, water and ventilation
requirements;
c) appropriate methods of animal handling during transport and associated activities such as
cleaning and disinfection, assembling, loading, and unloading;
d) species-specific aspects of animal handling and care, including appropriate equipment and
medication;
Article 3.7.2.3.
1. General considerations
a) Adequate planning is a key factor affecting the welfare of animals during a journey.
b) Before the journey starts, plans should be made in relation to:
i) type of transport vessel required;
ii) route, taking into account distance, expected weather and sea conditions;
iii) nature and duration of journey;
iv) daily care and management of the animals;
v) avoiding the mixing of animals from different sources in a single pen group;
vi) provision of appropriate equipment and medication for the numbers and species carried;
vii) emergency response procedures.
c) Preconditioning may be required, e.g. for dry food, and unfamiliar methods of supply of feed
and water.
d) Where there is a potential for spread of infectious disease, and when requested by the Veterinary
Authority of the importing country, animals should be vaccinated against diseases to which they are
likely to be exposed at their destination.
e) There should be planning for water and feed availability during the journey. Feed should be of
appropriate quality and composition for the species, age, condition of the animals, etc.
f) Extreme weather conditions are hazards for animals undergoing transport and require
appropriate vessel design to minimise risks. Special precautions should be taken for animals that
have not been acclimatised or which are unsuited to either hot or cold conditions. In some
extreme conditions of heat or cold, animals should not be transported at all.
g) Behaviour-modifying or other medication should not be used routinely during transport. Such
medicines should only be administered when a problem exists in an individual animal, and
should be administered by a veterinarian or other person who has been instructed in their use
by a veterinarian. Treated animals should be placed in a dedicated area.
h) There should be an emergency management plan that identifies the important adverse events
that may be encountered during the journey, the procedures for managing each event and the
action to be taken in an emergency. For each important event, the plan should document the
actions to be undertaken and the responsibilities of all parties involved, including
communications and record keeping.
2. Vessel and container design and maintenance
a) Vessels used for the sea transport of animals should be designed, constructed and fitted as
appropriate to the species, size and weight of the animals to be transported. Special attention
should be paid to the avoidance of injury to animals through the use of secure smooth fittings
free from sharp protrusions and the provision of non-slip flooring. The avoidance of injury to
animal handlers while carrying out their responsibilities should be emphasised.
b) Vessels should be designed to permit thorough cleaning and disinfection, and the management of
faeces and urine.
c) Vessels should be maintained in good mechanical and structural condition.
d) Vessels should have adequate ventilation to meet variations in climate and the
thermo-regulatory needs of the animal species being transported. The ventilation system should
be capable of operating when the vessel is stationary and the air flow should be adjustable.
e) The feeding and watering system should be designed to permit adequate access to feed and
water appropriate to the species, size and weight of the animals, and to minimise soiling of pens.
f) Vessels should be designed so that the faeces or urine from animals on upper levels do not soil
animals on lower levels, or their feed or water.
g) Loading and stowage of feed and bedding should be carried out in such a way to ensure
protection from fire hazards, the elements and sea water.
h) Where appropriate, suitable bedding, such as straw or sawdust, should be added to vessel floors
to assist absorption of urine and faeces, provide better footing for animals and protect animals
(especially young animals) from hard or rough flooring surfaces and adverse weather conditions.
i) The above principles apply also to containers used for the transport of animals.
3. Special provisions for transport in road vehicles on roll-on/roll-off vessels or for containers
a) Road vehicles and containers should be equipped with a sufficient number of adequately
designed, positioned and maintained securing points enabling them to be securely fastened to
the vessel.
b) Road vehicles and containers should be secured to the ship before the start of the sea journey to
prevent them being displaced by the motion of the vessel.
c) Vessels should have adequate ventilation to meet variations in climate and the
thermo-regulatory needs of the animal species being transported, especially where the animals
are transported in a secondary vehicle/container on enclosed decks.
4. Space allowance
a) The number of animals which should be transported on a vessel and their allocation to different
pens on the vessel should be determined before loading.
b) The amount of space required, including headroom, depends on the species of animal and
should allow the necessary thermoregulation. Each animal should be able to assume its natural
position for transport (including during loading and unloading) without coming into contact
with the roof or upper deck of the vessel. When animals lie down, there should be enough
space for every animal to adopt a comfortable, normal lying posture.
c) Calculations for the space allowance for each animal should be carried out, using the figures
given in these guidelines or, in their absence, in a relevant national or international document.
The size of pens will affect the number of animals in each.
d) The same principles apply when animals are transported in containers.
5. Ability to observe animals en route
a) Animals should be positioned to enable them to be observed regularly during the journey to
ensure their safety and good welfare.
b) To allow an adequate inspection of animals en route, it should be possible for each animal to be
clearly observed by the animal handler or other responsible person.
6. Emergency response procedures
Appropriate contingency plans to address emergencies should be prepared in advance.
Article 3.7.2.4.
Documentation
1. Animals should not be loaded until the documentation required to that point is complete.
Article 3.7.2.5.
Pre-journey period
1. General considerations
a) Before each journey, vessels should be thoroughly cleaned and treated for animal and public
health purposes, using chemicals approved by the Competent Authority. When cleaning is
necessary during a journey, this should be carried out with the minimum of stress to the
animals.
b) In some circumstances, animals may require pre-journey assembly. In these circumstances, the
following points should be considered:
i) For animals such as pigs which are susceptible to motion sickness, and in order to reduce
urine and faeces production during the journey, a short period of feed deprivation prior to
loading is desirable.
ii) When animals will be provided with a novel diet or method of water provision during or
after transport, an adequate period of pre-exposure is necessary. Preconditioning to the
feed to be used on the vessel may be necessary in such cases.
c) Pre-journey holding areas should be designed to:
i) securely contain the animals;
ii) maintain an environment safe from hazards, including predators and disease;
iii) protect animals from exposure to adverse weather conditions; and
iv) allow for rest, watering and feeding.
Compatible groups should be selected before transport to avoid adverse animal welfare
consequences. The following guidelines should be applied when assembling groups of animals:
a) animals of different species should not be mixed unless they are judged to be compatible;
b) animals of the same species can be mixed unless there is a significant likelihood of aggression;
aggressive individuals should be segregated;
c) young or small animals may need to be separated from older or larger animals, with the
exception of nursing mothers with young at foot;
d) animals with horns or antlers should not be mixed with animals lacking horns or antlers;
e) animals reared together should be maintained as a group; animals with a strong social bond,
such as a dam and offspring, should be transported together.
3. Fitness to travel
a) Animals should be inspected before travel and those found unfit to travel by farm staff, animal
handlers or veterinarians should not be loaded onto a vessel.
b) Humane and effective arrangements should be made by the owner or agent for the handling
and care of any animal rejected as unfit to travel.
ii) those that are unable to stand unaided and bear weight on each leg;
iv) those that cannot be moved without causing them additional suffering;
vi) females travelling without young which have given birth within the previous 48 hours;
vii) pregnant animals which would be in the final 10% of their gestation period at the planned
time of unloading.
d) Risks during transport can be reduced by selecting animals best suited to the conditions of
travel and those that are acclimatised to expected weather conditions.
e) Animals at risk, and requiring better conditions and additional attention during transport
include:
f) Hair or wool length needs consideration in relation to the weather conditions expected.
Article 3.7.2.6.
Loading
1. Experienced supervision
a) Loading should be carefully planned as it has the potential to be the cause of poor welfare in
transported animals.
b) Loading should be supervised by the Competent Authority and managed by an animal handler(s).
Animal handlers should ensure that animals are loaded quietly and without unnecessary noise,
harassment or force, and that untrained assistants or spectators do not impede the process.
c) Ventilation during loading and the journey should provide for fresh air, and the removal of
excessive heat, humidity and noxious fumes (such as ammonia and carbon monoxide). Under
warm and hot conditions, ventilation should allow for the adequate convective cooling of each
animal. In some instances, adequate ventilation can be achieved by increasing the space
allowance for animals.
2. Facilities
a) The facilities for loading including the collecting area at the wharf, races and loading ramps
should be designed and constructed to take into account of the needs and abilities of the
animals with regard to dimensions, slopes, surfaces, absence of sharp projections, flooring,
sides, etc.
b) All loading facilities should be properly illuminated to allow the animals to be easily inspected
by the animal handler(s), and to allow the animals’ ease of movement at all times.
a) Goads (aids for encouraging animals to move) should not be used on animals that have little or
no room to move.
b) Useful and permitted goads include panels, flags, plastic paddles, flappers (a length of cane with
a short strap of leather or canvas attached), plastic bags and metallic rattles; they should be used
in a manner sufficient to encourage and direct movement of the animals but without physical
contact with them.
c) Unsuitable goads such as large wooden sticks, sticks with sharp ends, lengths of metal piping,
fencing wire or heavy leather belts should not be used to strike animals.
d) The use of goads which administer electric shocks should be discouraged, and restricted to that
necessary to assist movement of the animal. If such use is necessary, it should be limited to the
hindquarters of pigs and large ruminants, and never on sensitive areas such as the eyes, mouth,
ears, anogenital region or belly. Such instruments should not be used on horses, sheep and
goats of any age, or on calves or piglets.
e) The use of well trained dogs to help with the loading of some species may be acceptable.
f) Manual lifting is permissible for young animals that may have difficulty negotiating ramps, but
the lifting of animals by their tail, head, horns, ears, limbs, wool or hair should not be permitted.
Article 3.7.2.7.
Travel
1. Inspections
a) Animal handler(s) should check the consignment immediately before departure to ensure that
the animals have been loaded according to the load plan. Each consignment should be checked
again within 24 hours.
b) Adjustments should be made to the stocking density within 48 hours of departure and as
appropriate during the journey.
c) Each pen of animals should be observed on a daily basis for normal behaviour, health and
welfare, and the correct operation of ventilation, watering and feeding systems. There should
also be a night patrol. Any necessary corrective action should be undertaken promptly.
d) Adequate access to suitable feed and water should be ensured for all animals in each pen.
2. Sick and injured animals
a) Sick or injured animals should be segregated/isolated.
b) Sick or injured animals should be treated promptly and appropriately, and veterinary advice
should be sought if necessary. All drugs and products should be used in accordance with the
manufacturer’s or veterinarian’s recommendations.
c) A record of treatments carried out and their outcomes should be kept.
d) When euthanasia is necessary, the person responsible for the animals must ensure that it is
carried out humanely, and results in immediate death. When necessary, assistance should be
sought from a veterinarian or other person(s) competent in euthanasia procedures.
Recommendations for specific species are described in Appendix 3.7.6. on humane killing of
animals for disease control purposes.
3. Cleaning and disinfection
a) Vessels and containers used to carry the animals should be cleaned before re-use through the
physical removal of manure and bedding by scraping, washing and flushing vessels and
containers with water. This should be followed by disinfection when there are concerns about
disease transmission.
b) Manure, litter and bedding should be disposed of in such a way as to prevent the transmission
of disease and in compliance with all relevant health and environmental legislation.
c) Where cleaning or disinfestation is necessary during travel, it should be carried out with the
minimum stress to the animals.
Article 3.7.2.8.
1. General considerations
a) The required facilities and the principles of animal handling detailed in Article 3.7.2.6. apply
equally to unloading, but consideration should be given to the likelihood that the animals will be
fatigued.
b) Unloading should be carefully planned as it has the potential to be the cause of poor welfare in
transported animals.
c) A livestock vessel should have priority attention when arriving in port and have priority access
to a berth with suitable unloading facilities. As soon as possible after the ship’s arrival at the
port and acceptance of the consignment by the Competent Authority, animals should be unloaded
into appropriate facilities.
d) The accompanying veterinary certificate and other documents should meet the requirements of
the importing country. Veterinary inspections should be completed as quickly as possible.
e) Unloading should be supervised by the Competent Authority and managed by a competent animal
handler(s). The animal handlers should ensure that animals are unloaded quietly and without
unnecessary noise, harassment or force, and that untrained assistants or spectators do not
impede the process.
2. Facilities
a) The facilities for unloading including the collecting area at the wharf, races and unloading ramps
should be designed and constructed to take into account of the needs and abilities of the
animals with regard to dimensions, slopes, surfaces, absence of sharp projections, flooring,
sides, etc.
b) All unloading facilities should be properly illuminated to allow the animals to be easily inspected
by the animal handler(s), and to allow the animals’ ease of movement at all times.
c) In case of emergencies, port facilities should provide animals with appropriate care and
comfort, adequate space, access to quality feed and clean drinking water, and shelter from
extreme weather conditions.
3. Sick and injured animals
a) In some cases, where animals are non-ambulatory due to fatigue, injury or sickness, it may be in
the best welfare interests of the animal to be treated or euthanased aboard the vessel.
b) If unloading is in the best welfare interests of animals that are fatigued, injured or sick, there
should be appropriate facilities and equipment for the humane unloading of such animals.
These animals should be unloaded in a manner that causes the least amount of suffering. After
unloading, appropriate facilities and treatments should be provided for sick or injured animals.
Article 3.7.2.9.
1. The welfare of the animals should be the first consideration in the event of a refusal to import.
2. When a shipment has been refused import, the Competent Authority of that country should make
available suitable isolation facilities to allow the unloading of animals from a vessel and their secure
holding, without posing a risk to the health of the national herd, pending resolution of the situation.
In this situation, the priorities should be:
a) the Competent Authority of the importing country should provide urgently in writing the reasons
for the refusal;
b) in the event of a refusal for animal health reasons, the Competent Authority of the importing
country should provide urgent access to an OIE-appointed veterinarian(s) to assess the animals’
health status with regard to the importing country’s concerns, and the necessary facilities and
approvals to expedite the required diagnostic testing;
c) the Competent Authority of the importing country should provide access to allow continued
assessment of the ongoing health and welfare situation;
d) if the matter cannot be promptly resolved, the Competent Authority of the exporting country and
the importing country should call on the OIE to mediate.
3. In the event that the animals are required to remain on the vessel, the priorities should be:
a) the Competent Authority of the importing country should allow reprovision of the vessel with water
and feed as necessary;
b) the Competent Authority of the importing country should provide urgently in writing the reasons
for the refusal;
c) in the event of a refusal for animal health reasons, the Competent Authority of the importing
country should provide urgent access to an OIE-appointed veterinarian(s) to assess the animals’
health status with regard to the importing country’s concerns, and the necessary facilities and
approvals to expedite the required diagnostic testing;
d) the Competent Authority of the importing country should provide access to allow continued
assessment of the ongoing health and welfare situation;
e) if the matter cannot be urgently resolved, the Competent Authorities of the exporting country and
the importing country should call on the OIE to mediate.
4. The OIE should utilise its dispute settlement mechanism to identify a mutually agreed solution
which will address the animal health and welfare issues in a timely manner.
Article 3.7.2.10.
Cattle are sociable animals and may become agitated if they are singled out. Social order is usually
established at about two years of age. When groups are mixed, social order has to be re-established and
aggression may occur until a new order is established. Crowding of cattle may also increase aggression as
the animals try to maintain personal space. Social behaviour varies with age, breed and sex; Bos indicus
and B. indicus-cross animals are usually more temperamental than European breeds. Young bulls, when
moved in groups, show a degree of playfulness (pushing and shoving) but become more aggressive and
territorial with age. Adult bulls have a minimum personal space of six square metres. Cows with young
calves can be very protective, and handling calves in the presence of their mothers can be dangerous.
Goats should be handled calmly and are more easily led or driven than if they are excited. When goats are
moved, their gregarious tendencies should be exploited. Activities which frighten, injure or cause agitation
to animals should be avoided. Bullying is particularly serious in goats. Housing strange goats together
could result in fatalities, either through physical violence, or subordinate goats being refused access to
food and water.
Sheep are sociable animals with good eyesight and tend to “flock together”, especially when they are
agitated. They should be handled calmly and their tendency to follow each other should be exploited
when they are being moved. Sheep may become agitated if they are singled out for attention and will
strive to rejoin the group. Activities which frighten, injure or cause agitation to sheep should be avoided.
They can negotiate steep ramps.
Pigs have poor eyesight, and may move reluctantly in strange surroundings. They benefit from well lit
loading bays. Since they negotiate ramps with difficulty, these should be as level as possible. Ideally, a
hydraulic lift should be used for greater heights. Pigs also negotiate steps with difficulty. A good
‘rule-of-thumb’ is that no step should be higher than the pig’s front knee.
Horses in this context include all solipeds, donkeys, mules, hinnies and zebra. They have good eyesight
and a very wide angle of vision. They may have a history of loading resulting in good or bad experiences.
Good training should result in easier loading, but some horses can prove difficult, especially if they are
inexperienced or have associated loading with poor transport conditions. In these circumstances, two
experienced handlers can load an animal by linking arms or using a strop below its rump. Blindfolding
may even be considered. Ramps should be as shallow as possible. Steps are not usually a problem when
horses mount a ramp, but they tend to jump a step when descending, so steps should be as low as
possible. Horses benefit from being individually stalled, but may be transported in compatible groups.
When horses are to travel in groups, their shoes should be removed.
Camelids in this context comprise llamas, alpacas, guanaco and vicuna. They have good eyesight and, like
sheep, can negotiate steep slopes, though ramps should be as shallow as possible. They load most easily in
a bunch as a single animal will strive to rejoin the others. Whilst they are usually docile, they have an
unnerving habit of spitting in self-defence. During transport, they usually lie down. They frequently
extend their front legs forward when lying, so gaps below partitions should be high enough so that their
legs are not trapped when the animals rise.
1 An animal handler is a person with a knowledge of the behaviour and needs of animals which,
with appropriate experience and a professional and positive response to an animal’s needs,
results in effective management and good welfare; their competence should be demonstrated
through independent assessment and certification.
Article 3.7.3.1.
Responsibilities
The welfare of animals during their transport is the joint responsibility of all people involved.
The roles of each of those responsible are defined below:
1. Owners and managers of animals are responsible for the general health of the animals and their
fitness for the journey, and their welfare during the journey, regardless of whether duties are
subcontracted to other parties during transport. They are also responsible for ensuring compliance
with any required veterinary or other certification, and for the presence during the journey of at least
one animal handler1 competent for the species being transported, with the authority to take prompt
action. They are also responsible for ensuring that equipment and veterinary assistance are provided
as appropriate for the species and journey.
2. Business agents or buying/selling agents have a joint responsibility with owners for the selection of
animals that are fit to travel. They have a joint responsibility with market owners and managers of
facilities at the start and at the end of the journey for the availability of suitable facilities for the
assembly, loading, transport, unloading and holding of animals, and for emergencies.
3. Animal handlers are responsible for the humane handling and care of the animals, especially during
loading and unloading, and for maintaining a journey log. In the absence of a separate animal
handler, the driver is the animal handler.
4. Transport companies, vehicle owners and drivers are responsible for planning the journey to ensure
the care of the animals:
a) transport companies and vehicle owners are responsible for choosing appropriate vehicles and
ensuring that properly trained staff are available for loading and caring for animals;
b) transport companies and vehicle owners are responsible for developing and keeping up to date
contingency plans to address emergencies and minimise stress during transport;
c) transport companies and vehicle owners are responsible for producing a journey plan which
includes a loading plan, journey duration and location of resting places;
d) drivers are responsible for loading only those animals which are fit to travel, for their correct
loading into the vehicle and their inspection during the journey, and for appropriate responses
to problems arising.
5. Managers of facilities at the start and at the end of the journey and at resting points are responsible
for:
a) providing suitable premises for loading, unloading and securely holding the animals, with water
and feed when required, until further transport, sale or other use (including rearing or
slaughter);
b) providing competent animal handlers to load, unload, drive and hold animals in a manner that
causes minimum stress and injury;
c) minimising the opportunities for disease transmission;
d) providing appropriate facilities, with water and feed when required;
e) providing appropriate facilities for emergencies;
f) providing facilities for washing and disinfecting vehicles after unloading;
g) providing facilities and competent staff to allow the humane killing of animals when required;
h) ensuring proper rest times and minimal delay during stops.
6. The responsibilities of Competent Authorities include:
a) establishing minimum standards for animal welfare, including requirements for inspection of
animals before, during and after their travel, and appropriate certification and record keeping;
b) approving facilities, containers and vehicles for the transport of animals;
c) setting standards for the competence of drivers, animal handlers and managers;
d) ensuring appropriate awareness and training of drivers, animal handlers and manager;
e) implementation of the standards, including through accreditation of / interaction with other
organisations;
f) monitoring and evaluating the effectiveness of standards of health and other aspects of welfare;
g) monitoring and evaluating the use of veterinary medications.
7. All individuals, including veterinarians, involved in transporting animals and the associated handling
procedures should receive appropriate training and be competent to meet their responsibilities.
Article 3.7.3.2.
Competence
1. All people handling animals, or who are otherwise responsible for animals during journeys, should be
competent according to their responsibilities listed in Article 3.7.3.1. Competence may be gained
through formal training and/or practical experience. Competence in areas other than animal welfare
would need to be addressed separately.
2. The competence of animal handlers should be demonstrated through a current certificate from an
independent body, accredited by the Competent Authority. The certificate should be in one of the OIE
official languages if the international transport of animals is involved.
3. The assessment of the competence of animal handlers should at a minimum address knowledge, and
ability to apply that knowledge, in the following areas:
a) planning a journey, including appropriate space allowance, and feed, water and ventilation
requirements;
b) responsibilities for animals during the journey, including loading and unloading;
c) sources of advice and assistance;
d) animal behaviour, general signs of disease, and indicators of poor animal welfare such as stress,
pain and fatigue, and their alleviation;
e) relevant authorities and applicable transport regulations, and associated documentation
requirements;
f) general disease prevention procedures, including cleaning;
Article 3.7.3.3.
1. General considerations
a) Adequate planning is a key factor affecting the welfare of animals during a journey.
b) Before the journey starts, plans should be made in relation to:
i) preparation of animals for the journey;
ii) choice of road or rail;
iii) nature and duration of the journey;
iv) vehicle / container design and maintenance, including roll-on roll-off vessels;
v) required documentation;
vi) space allowance;
vii) rest, water and feed;
viii) observation of animals en route;
ix) control of disease; and
x) emergency response procedures.
c) Regulations concerning drivers (for example, maximum driving periods) should be harmonised
with maximum transport journey intervals appropriate for the species.
2. Preparation of animals for the journey
a) When animals are to be provided with a novel diet or method of water provision during
transport, an adequate period of adaptation should be planned.
b) Animals should be exposed to appropriate contact with humans and handling conditions
(including methods of restraint) prior to transport to reduce their fearfulness and improve their
approachability (see Article 3.7.3.5.).
c) Behaviour-modifying compounds (such as tranquillisers) should not be used routinely during
transport. Such compounds should only be administered when a problem exists in an individual
animal, and should be administered by a veterinarian or other person who has been instructed
in their use by a veterinarian.
3. Nature and duration of the journey
The maximum duration of a journey should be determined according to:
a) the ability of the animals to cope with the stress of transport (such as very young, old, lactating
or pregnant animals);
b) the animals’ previous transport experience;
c) the onset of fatigue;
d) the need for special attention;
c) When animals lie down, they should all be able to adopt a comfortable, normal lying posture
which allows necessary thermoregulation.
d) When animals are standing, they should have sufficient space to adopt a balanced position.
e) The amount of headroom necessary depends on the species of animal. Each animal should be
able to assume its natural position for transport (including during loading and unloading)
without coming into contact with the roof or upper deck of the vehicle.
f) Calculations according to the space allowance permitted for each animal should be carried out
using the figures given in Appendix XXX or, in their absence, in a relevant national or
international document. The size of already established groups will affect the number and size
of the pens, and the distribution of animals in pens on the vehicle.
g) Other factors which may influence space allowance include:
i) vehicle / container design;
ii) length of journey;
iii) need to provide feed and water on the vehicle;
iv) quality of roads;
v) expected weather conditions.
7. Rest, water and feed
a) There should be planning for the availability of suitable water and feed during the journey. Feed
should be of appropriate quality and composition for the species, age, condition of the animals,
climatic conditions, etc.
b) Animals should be rested at resting points at appropriate intervals during the journey. The type
of transport and species being transported should determine the frequency of rest stops and
whether the animals are unloaded. There should be planning for water and feed availability
during rest stops.
8. Ability to observe animals en route in relation to journey duration
a) Animals should be positioned to enable each animal to be observed regularly during the journey
to ensure their safety and good welfare.
b) If the animals are in crates or on multi-tiered vehicles which do not allow free access for
observation, for example where the roof of the tier is too low (i.e. less than 1.3 m), animals
cannot be inspected adequately, and serious injury or disease could go undetected. In these
circumstances, a shorter journey duration should be allowed, and the maximum duration will
vary according to the rate at which problems arise in the species and under the conditions of
transport.
9. Control of disease
As animal transport is often a significant factor in the spread of infectious diseases, journey planning
should take the following into account:
a) mixing of animals from different sources in a single consignment should be minimised;
b) contact at resting points between animals from different sources should be avoided;
c) when possible, animals should be vaccinated against diseases to which they are likely to be
exposed at their destination;
d) medications used prophylactically or therapeutically should only be administered by a
veterinarian or other person who has been instructed in their use by a veterinarian.
10. Emergency response procedures
Appropriate contingency plans to address emergencies should be prepared in advance.
Article 3.7.3.4.
Documentation
Article 3.7.3.5.
Pre-journey period
1. General considerations
a) Pre-journey rest is necessary if the welfare of animals has become poor during the collection
period because of the physical environment or the social behaviour of the animals.
b) Feed and water should be provided pre-journey if the journey duration is greater than the
normal inter-feeding and drinking interval for the animal. Recommendations for specific species
are described in detail in Article 3.7.3.10.
c) When animals will be provided with a novel diet or method of water provision during or after
transport, an adequate period of pre-exposure is necessary.
d) Before each journey, vehicles and containers should be thoroughly cleaned and, if necessary,
treated for animal health and public health purposes, using methods approved by the Competent
Authority. When cleaning is necessary during a journey, this should be carried out with the
minimum of stress to the animals.
e) Where an animal handler believes that there is a significant risk of disease among the animals to
be loaded or significant doubt as to their fitness to travel, the animals should be inspected by a
veterinarian.
2. Selection of compatible groups
Compatible groups should be selected before transport to avoid adverse animal welfare
consequences. The following guidelines should be applied when assembling groups of animals:
a) animals reared together should be maintained as a group; animals with a strong social bond
should be transported together;
b) animals of the same species should not be mixed if there is a significant likelihood of
aggression; aggressive individuals should be segregated (recommendations for specific species
are described in detail in Article 3.7.3.10.); for some species, animals from different groups
should not be mixed because poor welfare occurs unless they have established a social structure;
c) young or small animals should be separated from older or larger animals, with the exception
that dam and offspring should be transported together;
d) animals with horns or antlers should not be mixed with animals lacking horns or antlers;
e) animals of different species should not be mixed unless they are judged to be compatible.
3. Shelter in the assembly/holding area
Assembly/holding areas should be designed to:
a) securely hold the animals;
b) maintain a safe environment from hazards, including predators and disease;
c) protect animals from exposure to severe weather conditions;
d) allow for maintenance of social groups, and
e) allow for rest, and appropriate water and feed.
4. Effect of travel experience, long and short term
a) Consideration should be given to an animal’s previous transport experience, training and
conditioning as these may reduce fear and stress in animals. Animals that are carefully and
regularly transported may show less adverse responses to transport.
b) Exposure to familiar personnel should reduce the fearfulness of animals and improve their
approachability during transport procedures.
5. Fitness to travel
a) Each animal should be inspected by a veterinarian or an animal handler to assess fitness to
travel. Animals found unfit to travel should not be loaded onto a vehicle, except for transport
to receive veterinary treatment.
b) Humane and effective arrangements should be made by the owner or agent for the handling
and care of any animal rejected as unfit to travel.
c) Animals that are unfit to travel include:
i) those that are sick, injured, weak, disabled or fatigued;
ii) those that are unable to stand unaided and bear weight on each leg;
Article 3.7.3.6.
Loading
1. Experienced supervision
a) Since loading has been shown to be the procedure most likely to be the cause of poor welfare in
transported animals, the methods to be used should be carefully planned.
b) Loading should be supervised by animal handlers. These animal handlers should ensure that
animals are loaded quietly and without unnecessary noise, harassment or force, and that
untrained assistants or spectators do not impede the process.
c) When containers are loaded onto a vehicle, this should be carried out in such a way to avoid
poor animal welfare.
2. Facilities
a) The facilities for loading including the collecting area, races and loading ramps should be
designed and constructed to take into account the needs and abilities of the animals with regard
to dimensions, slopes, surfaces, absence of sharp projections, flooring, etc.
b) Loading facilities should be properly illuminated to allow the animals to be observed by the
animal handler(s), and to allow the animals’ ease of movement at all times. Facilities should
provide uniform lighting directly over approaches to sorting pens, chutes, loading ramps, with
brighter lighting inside vehicles / containers, in order to minimise baulking. Dim lighting may
be advantageous for the catching of poultry and some other animals.
c) Ventilation during loading and the journey should provide for fresh air, the removal of
excessive heat, humidity and noxious fumes (such as ammonia and carbon monoxide), and the
prevention of accumulations of ammonia and carbon dioxide. Under warm and hot conditions,
ventilation should allow for the adequate convective cooling of each animal. In some instances,
adequate ventilation can be achieved by increasing the space allowance for animals.
3. Goads and other aids
The following principles should apply:
a) Animals which have little or no room to move should not be subjected to physical force or
goads and other aids which compel movement.
b) Useful and permitted aids include panels, flags, plastic paddles, flappers (a length of cane with a
short strap of leather or canvas attached), plastic bags and metallic rattles; they should be used
in a manner sufficient to encourage and direct movement of the animals but without physical
contact with them.
c) Painful procedures (including whipping, tail twisting, use of nose twitches, pressure on eyes,
ears or external genitalia), or the use of unsuitable goads or other aids (including sticks with
sharp ends, lengths of metal piping, fencing wire or heavy leather belts), should not be used to
move animals.
d) The use of goads which administer electric shocks should be discouraged, and restricted to that
necessary to assist movement of the animal. Such use should be limited to battery-powered
goads on the hindquarters of adult pigs and cattle, and never on sensitive areas such as the eyes,
mouth, ears, anogenital region or belly. Such instruments should not be used on other animals.
e) The use of well trained dogs to help with the loading of some species may be acceptable.
f) The throwing or dropping of animals, or their lifting or dragging by their tail, head, horns, ears,
limbs, wool, hair or feathers, should not be permitted. The manual lifting of small animals is
permissible.
Article 3.7.3.7.
Travel
1. General considerations
a) Drivers and animal handlers should check the load immediately before departure to ensure that
the animals have been properly loaded. Each load should be checked again early in the trip and
adjustments made as appropriate. Periodic checks should be made throughout the trip.
b) Drivers should utilise smooth, defensive driving techniques, without sudden turns or stops, to
minimise uncontrolled movements of the animals.
2. Methods of restraining or containing animals
a) Methods of restraining animals should be appropriate to the species involved and the training
of the individual animal.
b) Recommendations for specific species are described in detail in Article 3.7.3.10.
3. Regulating the environment within vehicles or containers
a) Animals should be protected against harm from hot or cold conditions during travel. Effective
ventilation procedures for maintaining the animals’ environment within vehicles or containers
will vary according to whether conditions are cold, hot and dry or hot and humid, but in all
conditions a build-up of noxious gases should be prevented. Specific temperature and humidity
parameters are described in detail in Appendix XXX.
b) The animals’ environment in hot weather can be regulated by the flow of air produced by the
movement of the vehicle. In warm and hot weather, the duration of journey stops should be
minimised and vehicles should be parked under shade, with maximal ventilation.
c) To minimise slipping and soiling, and maintain a healthy environment, urine and faeces should
be removed from floors when necessary and disposed of in such a way as to prevent the
transmission of disease and in compliance with all relevant health and environmental legislation.
4. Sick, injured and dead animals
a) A driver or animal handler finding sick, injured or dead animals should act according to a
predetermined emergency response plan.
b) If possible, sick or injured animals should be segregated.
c) Ferries (roll-on roll-off) should have procedures to treat sick or injured animals during the
journey.
d) In order to reduce the likelihood that animal transport will increase the spread of infectious
disease, contact between transported animals, or the products of the transported animals, and
other farm animals should be minimised.
e) During the journey, when disposal of a dead animal becomes necessary, this should be carried
out in such a way as to prevent the transmission of disease and in compliance with all relevant
health and environmental legislation.
f) When euthanasia is necessary, the driver or animal handler should ensure that it is carried out
humanely, and results in immediate death. When necessary, assistance should be sought from a
veterinarian or other person(s) competent in euthanasia procedures. Recommendations for
specific species are described in Appendix 3.7.6. on humane killing of animals for disease
control purposes.
5. Water and feed requirements
a) If journey duration is such that feeding or watering is required or if the species requires feed or
water throughout, access to suitable feed and water for all the animals carried in the vehicle
should be provided. There should be adequate space for all animals to move to the feed and
water sources and due account taken of likely competition for feed.
b) Recommendations for specific species are described in detail in Article 3.7.3.10.
6. Rest periods and conditions including hygiene
a) Animals that are being transported should be rested at appropriate intervals during the journey
and offered feed and water, either on the vehicle or, if necessary, unloaded into suitable
facilities.
b) Suitable facilities should be used en route, when resting requires the unloading of the animals.
These facilities should meet the needs of the particular animal species and should allow access
of all animals to feed and water.
7. In-transit observations
a) Animals being transported by road should be observed soon after a journey is commenced and
whenever the driver has a rest stop (with a maximum interval of 5 hours). After meal breaks and
refuelling stops, the animals should be observed immediately prior to departure.
b) Animals being transported by rail should be observed at each scheduled stop nearest to 5 hours
since the last observation. The responsible rail transporter should monitor the progress of trains
carrying animals and take all appropriate action to minimise delays.
c) During stops, it should be ensured that the animals continue to be properly confined, have
appropriate feed and water, and their physical condition is satisfactory.
Article 3.7.3.8.
1. General considerations
a) The required facilities and the principles of animal handling detailed in Article 3.7.3.6. apply
equally to unloading, but consideration should be given to the likelihood that the animals will be
fatigued.
b) Unloading should be supervised by an animal handler with knowledge and experience of the
behavioural and physical characteristics of the species being unloaded. Animals should be
unloaded from the vehicle into appropriate facilities as soon as possible after arrival at the
destination but sufficient time should be allowed for unloading to proceed quietly and without
unnecessary noise, harassment or force.
c) Facilities should provide all animals with appropriate care and comfort, adequate space and
ventilation, access to feed (if appropriate) and water, and shelter from extreme weather
conditions.
d) For details regarding the unloading of animals at a slaughterhouse, see Appendix 3.7.5. on
slaughter of animals for human consumption.
2. Sick and injured animals
a) An animal that has become sick, injured or disabled during a journey should be appropriately
treated or humanely killed (see Appendix 3.7.6. on humane killing of animals for disease control
purposes). When necessary, veterinary advice should be sought in the care and treatment of
these animals.
b) At the destination, the animal handler during transit should ensure that responsibility for the
welfare of sick, injured or disabled animals is transferred to a suitable person.
c) There should be appropriate facilities and equipment for the humane unloading of animals that
are non-ambulatory due to fatigue, injury or sickness. These animals should be unloaded in a
manner that causes the least amount of suffering. After unloading, separate pens and other
appropriate facilities should be available for sick or injured animals.
d) Feed, if appropriate, and water should be available for each sick or injured animal.
3. Addressing disease risks
The following should be taken into account in addressing the greater risk of disease due to animal
transport and the possible need for segregation of transported animals at the destination:
a) increased contact among animals, including those from different sources and with different
disease histories;
b) increased shedding of pathogens and increased susceptibility to infection related to stress and
impaired defences against disease, including immunosuppression;
c) exposure of animals to pathogens which may contaminate vehicles, resting points, markets, etc.
4. Cleaning and disinfection
a) Vehicles, crates, containers, etc. used to carry the animals should be cleaned before re-use
through the physical removal of manure and bedding by scraping, washing and flushing vehicles
and containers with water and detergent. This should be followed by disinfection when there are
concerns about disease transmission.
b) Manure, litter and bedding should be disposed of in such a way as to prevent the transmission
of disease and in compliance with all relevant health and environmental legislation.
c) When disposal of a dead animal becomes necessary, this should be carried out in such a way as
to prevent the transmission of disease and in compliance with all relevant health and
environmental legislation.
d) Establishments like livestock markets, slaughterhouses, resting sites, railway stations, etc. where
animals are unloaded should be provided with appropriate areas for the cleaning and disinfection
of vehicles.
e) Where disinfestation is necessary, it should be carried out with the minimum stress to the
animals.
Article 3.7.3.9.
1. The welfare of the animals should be the first consideration in the event of a refusal to allow the
completion of the journey.
2. When the animals have been refused import, the Competent Authority of that country should make
available suitable isolation facilities to allow the unloading of animals from a vehicle and their secure
holding, without posing a risk to the health of national herd or flock, pending resolution of the
situation. In this situation, the priorities should be:
a) the Competent Authority of the importing country should provide urgently in writing the reasons
for the refusal;
b) in the event of a refusal for animal health reasons, the Competent Authority of the importing
country should provide urgent access to a veterinarian, where possible an OIE veterinarian(s)
appointed by the Director General, to assess the animals’ health status with regard to the
importing country’s concerns, and the necessary facilities and approvals to expedite the required
diagnostic testing;
c) the Competent Authority of the importing country should provide access to allow continued
assessment of the health and other aspects of the welfare of the animals;
d) if the matter cannot be promptly resolved, the Competent Authorities of the exporting country and
the importing country should call on the OIE to mediate.
3. In the event that a Competent Authority requires the animals to remain on the vehicle, the priorities
should be:
a) the Competent Authority should allow reprovisionsing of the vehicle with water and feed as
necessary;
b) the Competent Authority should provide urgently in writing the reasons for the refusal;
c) in the event of a refusal for animal health reasons, the Competent Authority should provide
urgent access to an independent veterinarian(s) to assess the animals’ health status, and the
necessary facilities and approvals to expedite the required diagnostic testing;
d) the Competent Authority should provide access to allow continued assessment of the health and
other aspects of the welfare of the animals;
4. The OIE should utilise its dispute settlement mechanism to identify a mutually agreed solution
which will address animal health and any other welfare issues in a timely manner.
Article 3.7.3.10.
(To be developed)
1 An animal handler is a person with a knowledge of the behaviour and needs of animals which,
with appropriate experience and a professional and positive response to an animal’s needs,
results in effective management and good welfare; their competence should be demonstrated
through independent assessment and certification.
Article 3.7.4.1.
Livestock containers
1. Design
a) General principles of design
The container should:
- conform to the size of the standard pallet of the aircraft that will be used to transport
animals; the common sizes are: 224 x 318 cm (88 x 125 in.) and 244 x 318 cm
(96 x 125 in.);
- not be constructed of material that could be harmful to the animals health or welfare;
- allow observation of the animals and be marked on opposite sides with the International
Air Transport Association (IATA) symbols which indicate animals and the upright
position;
- allow emergency access to animals;
- allow the animal to stand in its normal position without touching the roof of the container
or, in the case of open containers, the restraining nets, and provide at least 10 cm (4 in.)
clearance above the animal's head when standing in its normal position; in the case of
horses, provide sufficient space above the horses head (21 cm, 8 in. recommended) to
allow for the movement required to maintain the horses balance;
- protect the animals from adverse weather;
- ensure animals stand on a suitable floor to prevent slipping or injury;
- have adequate strength to ensure the safety of the animals and to prevent the animals from
escaping;
- ensure doors can be opened and closed easily, but be secured so that they cannot be
opened accidentally;
- be free of any nails, bolts and other protrusions or sharp edges that could cause injuries;
- be designed to minimise the risk of any opening or space entrapping any portion of the
animals body;
- if reusable, crates should be constructed of impermeable material that is easily cleaned and
disinfected;
- ensure faeces and urine cannot escape from the crate; this requires a minimum upturn of
20 cm but it must not block any ventilation openings;
- if designated for stacking be stable, not block any ventilation space and prevent urine and
faeces from leaking into the containers below when stacked;
- allow for a facility for provision of water and possibly food during transportation of longer
than 6 hours duration.
b) Ventilation
The container design should:
- provide adequate ventilation taking into consideration the species stocking density,
maximum temperature and humidity of the points of departure, destination, and any
interim technical stops;
- allow the normal resting or sleeping position to be assumed for certain species and juvenile
animals;
- ensure there is no dead air space in the container;
- provide ventilation openings on the walls equal to at least 16% of the wall area; this may be
reduced if the container has an open top;
- in the case of two-tiered containers, ventilation in the sides should be for cattle equivalent
to not less than 20% of the floor area of each deck, and for pigs and sheep up to 40% of
the floor area of each deck;
- have ventilation openings on all four sides of the crate except that two walls may have
reduced ventilation space and the other walls have increased space where required by the
positioning of the crates during transportation and/or the ventilation pattern of the
aircraft;
- ensure that any internal supports or dividers do not block the cross ventilation;
- not have a solid wall above the height of the animal's head in normal resting position;
- in those species where the mouth is normally held near the floor, have at least 25 cm
(10 in.) of ventilation space at the level of the animal's head; this opening should be divided
in two with a maximum height for any opening of 13 cm; in all containers, there should be
a sufficiently large ventilation opening at a height of 25 cm to 30 cm (10 to 11 in.) above
floor level on all four sides to allow for circulation;
- have some physical means of ensuring the ventilation space is not blocked, such as the use
of cleats (wedges) or allowing space between the outside of the container and the pallet.
2. Species requirements
In general, fractious animals or animals in late pregnancy should not be transported by air (see
Article 3.7.4.2.).
a) Horses
Should be transported in containers and be separated from each other if they are more than
145 cm (57 in.) in height.
Crates used to transport horses should:
- be strong enough to prevent unruly horses from breaking or escaping from the container
under any circumstances;
- in the case of multi-horse containers, have partitions of sufficient strength and size to
separate the horses and to support each horse's weight;
- adjust to allow mare and foal to travel together;
- provide the same percentage of open space for ventilation as required in point 1 above,
divided between the two side walls; however, if the access doors are constructed in such a
manner that they may be left open during the flight, the door space may be included in the
ventilation space;
- be constructed to minimise noise;
- allow access to the head during the flight;
- have the front end notched and padded to accept the neck of the animal;
Article 3.7.4.2.
Heavily pregnant animals should not be carried except under exceptional circumstances. Pregnant animals
should not be accepted when the last service or exposure to a male prior to departure has exceeded the
following time given here for guidance only:
Where service dates or date of last exposure to a male are not available, the animals should be examined
by a veterinarian to ensure that pregnancy is not so advanced that animals are likely to give birth during
transport or suffer unnecessarily.
Any animal showing udder engorgement and slackening of the pelvic ligament should be refused.
Article 3.7.4.3.
Stocking density
The current stocking densities agreed by the International Air Transport Association (IATA) should
continue to be accepted. However, the graphs giving the space requirements should be extended to take
into account animals larger and smaller than those dealt with currently.
1. General considerations
When calculating stocking rates, the following should be taken into account:
a) it is essential that accurate weights of animals are obtained in view of the limitations imposed by
the load capabilities of the aircraft and the space required per animal;
b) in narrow bodied aircraft, there is a loss of floor area in the upper tier of two-tier penning due
to the contours of the aircraft;
c) space available should be calculated on the inside measurements of the crates or penning system
used, not on the floor space of the aircraft;
d) multi-tiered crates, high outdoor temperatures at departure, arrival or stopover points, or
extreme length of the trip will require an increase in the amount of space per animal; a
10% decrease in stocking density is recommended for trips in excess of 24 hours;
e) special attention should be paid to the transport of sheep in heavy wool which require an
increase in space allotted per animal and to pigs which have limited ability to dissipate heat;
f) animals confined in groups, especially in pens, should be stocked at a high enough density to
prevent injuries at take-off, during turbulence and at landing, but not to the extent that
individual animals cannot lie down and rise without risk of injury or crushing;
g) in multi-tiered shipments, it should be recognized that the ventilation and cooling capacity of
the aircraft is the limiting factor, especially in narrow bodied aircraft. Ventilation capacity varies
on each individual aircraft and between aircraft of the same model.
2. Guidelines for stocking densities
The following table gives stocking density guidelines for different domestic species:
Article 3.7.4.4.
Article 3.7.4.5.
1. Disinfection
a) Those parts of the interior of the aircraft destined for the carriage of animals should be
thoroughly cleaned of all foreign matters using methods acceptable to aircraft management
before being loaded.
b) These parts should be sprayed with a disinfectant
i) suitable for the diseases which could be carried by the animals;
ii) that does not cause problems with the aircraft;
iii) that will not leave a residue hazardous to the animals being transported.
If in doubt, the airline should be consulted on the suitability of the disinfectant. A mechanical
nebuliser should be used to minimise the amount of disinfectant used.
Suggested disinfectants currently in use are:
iv) 4% sodium carbonate and 0.1% sodium silicate;
v) 0.2% citric acid.
c) All removeable equipment, penning and containers including loading ramps should be
thoroughly cleaned and disinfected in accordance with the requirements of both the exporting
and importing countries.
d) After disinfection, all equipment to be replaced in the aircraft should be washed with clean water
to remove any traces of disinfectant to avoid any damage to the aircraft structures.
2. Disinsectisation
Where disinsectisation is required, the country requesting the action should be consulted for
appropriate procedures.
Article 3.7.4.6.
Radiation
Radioactive materials must be separated from live animals by a distance of at least 0.5 metre for journeys
not exceeding 24 hours, and by a distance of at least 1.0 metre for journeys longer than 24 hours
(reference: Technical instructions on storage and loading-separation of the International Civil Aviation
Organisation). Special care should be taken with regard to pregnant animals, semen and embryos/ova.
Article 3.7.4.7.
Tranquilization
Experience has shown that there is considerable risk in sedating animals transported by air. Tranquilizers
reduce the ability of the animals to respond to stress during transportation. In addition, the reaction of
various species to tranquilization cannot always be foreseen. For these reasons, routine tranquilization is
not recommended. Tranquilizers should only be used when a specific problem exists, and should be
administered by a veterinarian or by a person who has been instructed in their use. Persons using these
drugs should understand the full implications of the effects of the drug in air transport, e.g. certain
animals such as horses and elephants should not go down in containers. Drugs should only be
administered during the flight with the knowledge and consent of the captain.
In all cases, when tranquilizers are used, a note should be attached to the container stating the generic
name of the drug used, the dose and the time given.
Article 3.7.4.8.
Destruction of carcasses
In the event of any animal death on board, the competent authority of the airport of destination should
be notified in advance of landing.
Carcasses should be disposed of under the supervision of and to the satisfaction of the Veterinary
Authority of the country the aircraft is in.
The method of disposal should be based on the risk of introducing a controlled disease.
For carcasses which represent a high risk of introducing disease, the following is recommended:
1. destruction by incineration, rendering or deep burial under the supervision of the Veterinary
Authority;
2. if removed from the airport site, transportation in a closed, leakproof container.
Article 3.7.4.9.
Emergency slaughter
Emergency slaughter of animals in aircraft should, in general, only occur when the safety of the aircraft,
crew or other animals are involved.
Every aircraft transporting animals should have a method of killing the animals with minimum pain and
someone trained in that method.
In all cases when horses or other large animals are to be carried, the method of killing should be discussed
with the airline during the planning stages. Suitable methods are:
1. Captive bolt stunner, followed by an injection of a lethal chemical
a) Operator should be trained to use the captive bolt stunner on the species or type of animal
being transported.
b) An expert should determine that the type of captive bolt pistol is adequate for all the animals
being transported.
c) Some airlines and countries may prohibit the carriage of captive bolt pistols.
d) The user should recognise that the noise associated with the captive bolt may excite other
animals.
e) The requirement that the captive bolt pistol is accurately centered may be difficult to achieve
with an excited animal.
2. Injection of a chemical
a) Various chemicals may be used to sedate, immobilize or kill animals.
b) Central nervous system depressants such as barbiturate euthanasia solutions must be injected
directly into a vein to be effective. This is not normally practical for anyone but an experienced
veterinarian or an especially trained and experienced attendant, where the animal is sufficiently
fractious to require euthanasia.
c) Sedatives such as promazine and its derivatives may make the animal more fractious (see
Article 3.7.4.7.).
d) Immobilizing solutions such as succinylcholine are not humane.
3. Firearms
Airlines do not permit the use of firearms which discharge a free bullet because of the danger to the
aircraft.
Article 3.7.4.10.
Waste material which contains anything of animal origin including food, litter, manure, or animal feed
should be handled, collected and disposed of in a manner that ensures it will not be fed to livestock. It
should be collected in specified areas, and stored and transported in closed, leakproof containers.
Some importing countries legislation may prohibit or restrict the use of hay or straw during the
transportation period. Unloading of hay, straw, other animal feed and litter may be restricted or
prohibited by in transit countries.
Article 3.7.4.11.
Article 3.7.5.1.
General principles
1. Object
These guidelines address the need to ensure the welfare of food animals during pre-slaughter and
slaughter processes, until they are dead.
These guidelines apply to those domestic animals commonly slaughtered in slaughterhouses, that is:
cattle, buffalo, sheep, goats, deer, horses, pigs, ratites and poultry. Other animals, wherever they have
been reared, should be managed to ensure that their transport, lairaging, restraint and slaughter is
carried out without causing undue stress to the animals; the principles underpinning these guidelines
apply also to these animals.
2. Personnel
Persons engaged in the unloading, moving, lairaging, care, restraining, stunning, slaughter and
bleeding of animals play an important role in the welfare of those animals. For this reason, there
should be a sufficient number of personnel, who should be patient, considerate, competent and
familiar with thee guidelines outlined in the present Appendix and their application within the
national context.
The management of the slaughterhouse and the Veterinary Services should ensure that
slaughterhouse staff carry out their tasks in accordance with the principles of animal welfare.
3. Animal behaviour
Animal handlers should be experienced and competent in handling and moving farm livestock, and
understand the behaviour patterns of animals and the underlying principles necessary to carry out
their tasks.
The behaviour of individual animals or groups of animals will vary, depending on their breed, sex,
temperament and age and the way in which they have been reared and handled. Despite these
differences, the following behaviour patterns which are always present to some degree in domestic
animals, should be taken into consideration in handling and moving the animals.
Most domestic livestock are kept in herds and follow a leader by instinct.
Animals which are likely to be hostile to each other in a group situation should not be mixed at
slaughterhouses.
The desire of some animals to control their personal space should be taken into account in designing
facilities.
Domestic animals will try to escape if an animal handler approaches closer than a certain distance.
This critical distance, which defines the flight zone, varies among species and individuals of the same
species, and depends upon previous contact with humans. Animals reared in close proximity to
humans i.e. tame have no flight zone, whereas those kept in free range or extensive systems may
have flight zones which may vary from one metre to many metres. Animal handlers should avoid
sudden penetration of the flight zone which may cause a panic reaction which could lead to
aggression or attempted escape.
Animal handlers should use the point of balance at an animal’s shoulder to move animals, adopting a
position behind the point of balance to move an animal forward and in front of the point of balance
to move it backward.
Domestic animals have wide-angle vision but only have limited forward binocular vision and poor
perception of depth. This means that they can detect objects and movements beside and behind
them, but can only judge distances directly ahead.
Although all domestic animals have a highly sensitive sense of smell, they react in different ways to
the smells of slaughterhouses. Smells which cause fear or other negative responses should be taken
into consideration when managing animals.
Domestic animals can hear over a greater range of frequencies than humans and are more sensitive
to higher frequencies. They tend to be alarmed by constant loud noise and by sudden noises, which
may cause them to panic.
Article 3.7.5.2.
1. General considerations
The following principles should apply to unloading animals, moving them into lairage pens, out of
the lairage pens and up to the slaughter point:
a) The conditions of the animals should be assessed upon their arrival for any animal welfare
problems.
b) Injured or sick animals, requiring immediate slaughter, should be killed humanely at the site
where they are found.
c) The use of force on animals that have little or no room to move should not occur.
d) The use of instruments which administer electric shocks (e.g. goads and prods) and their power
output should be restricted to that necessary to assist movement of the animals. If such use is
necessary, it should be limited to the hindquarters of pigs and large ruminants, and never on
sensitive areas such as the eyes, mouth, ears, anogenital region or belly. Such instruments should
not be used on horses, sheep and goats of any age, or on calves or piglets, nor on animals that
have little or no room to move.
e) Performance standards should be established in which numerical scoring is used to evaluate the
use of such instruments and to measure the percentage of animals moved with an electric
instrument. In properly designed and constructed facilities with competent animal handlers, it
should be possible to move 75% or more of the animals without the use of electric instruments.
f) Useful and permitted aids for moving animals include panels, flags, plastic paddles, flappers (a
length of cane with a short strap of leather or canvas attached), plastic bags and metallic rattles;
they should be used in a manner sufficient to encourage and direct movement of the animals
but without physical contact with them.
g) Shouting or yelling at animals to encourage them to move should not occur as such actions may
make the animals agitated, leading to crowding or falling.
h) Implements which cause pain and suffering such as large sticks, sticks with sharp ends, metal
piping, fencing wire or heavy leather belts should not be used to move animals.
i) Animals should be grasped or lifted in a manner which avoids pain or suffering and physical
damage (e.g. bruising, fractures, dislocations). In the case of quadrupeds, manual lifting by a
person should only be used in young animals or small species, and in a manner appropriate to
the species; grasping or lifting such animals only by their wool, hair, feet, neck, ears or tails
causing pain or suffering should not be permitted, except in an emergency where animal welfare
or human safety may otherwise be compromised.
j) Conscious animals should not be thrown or dragged.
k) Animals should not be forced to move at a speed greater than their normal walking pace, in
order to minimise injury through falling or slipping. Performance standards should be
established where numerical scoring of the prevalence of animals slipping or falling is used to
evaluate whether animal moving practices and/or facilities should be improved. In properly
designed and constructed facilities with competent animal handlers, it should be possible to
move 99% of animals without their falling.
l) Animal handlers should not force an animal to walk over the top of other animals.
m) Under no circumstances should animal handlers resort to violent acts to move animals, such as
crushing or breaking animals’ tails, grasping animals’ eyes or pulling them by their ears. Animal
handlers should never apply an injurious object or irritant substance to sensitive areas such as
eyes, mouth, ears, anogenital region or belly.
2. Provisions relevant to animals delivered in containers
a) Containers in which animals are transported should be handled with care, and should not be
thrown, dropped or knocked over. Where possible, they should be loaded and unloaded
horizontally and mechanically.
b) Animals delivered in containers with perforated or flexible bottoms should be unloaded with
particular care in order to avoid injury. Where appropriate, animals should be unloaded from
the containers individually.
c) Animals which have been transported in containers should be slaughtered as soon as possible;
mammals and ratites which are not taken directly upon arrival to the place of slaughter should
have drinking water available to them from appropriate facilities at all times. Delivery of poultry
for slaughter should be scheduled such that they are not deprived of water at the premises for
longer than 12 hours. Animals which have not been slaughtered within 12 hours of their arrival
should be fed, and should subsequently be given moderate amounts of food at appropriate
intervals.
3. Provisions relevant to restraining and containing animals
a) Provisions relevant to restraining animals for stunning or slaughter without stunning, to help
maintain animal welfare, include:
i) provision of a non-slip floor;
ii) avoidance of excessive pressure applied by restraining equipment that causes struggling or
vocalisation in animals;
iii) equipment engineered to reduce noise of air hissing and clanging metal;
iv) absence of sharp edges in restraining equipment that would harm animals;
v) avoidance of jerking or sudden movement of restraining device.
b) Methods of restraint causing avoidable suffering, such as the following, should not be used in
conscious animals because they cause severe pain and stress:
i) suspending or hoisting animals (other than poultry) by the feet or legs;
ii) indiscriminate and inappropriate use of stunning equipment;
iii) mechanical clamping of an animal’s legs or feet (other than shackles used in poultry and
ostriches) as the sole method of restraint;
iv) breaking legs, cutting leg tendons or blinding animals in order to immobilise them;
v) severing the spinal cord, for example using a puntilla or dagger, to immobilise animals
using electric currents to immobilise animals, except for proper stunning.
Article 3.7.5.3.
1. General considerations
The lairage should be designed and constructed to hold an appropriate number of animals in relation
to the throughput rate of the slaughterhouse without compromising the welfare of the animals.
In order to permit operations to be conducted as smoothly and efficiently as possible without injury
or undue stress to the animals, the lairage areas should be designed and constructed so as to allow
the animals to move freely in the required direction, using their behavioural characteristics and
without undue penetration of their flight zone.
The following guidelines may help to achieve this.
2. Design of lairages
a) The lairage should be designed to allow a one-way flow of animals from unloading to the point
of slaughter, with a minimum of abrupt corners to negotiate.
b) In red meat slaughterhouses, pens, passageways and races should be arranged in such a way as
to permit inspection of animals at any time, and to permit the removal of sick or injured animals
when considered to be appropriate, for which separate appropriate accommodation should be
provided.
c) Each animal should have room to stand up and lie down and, when confined in a pen, to turn
around. The lairage should have sufficient accommodation for the number of animals intended
to be held. Drinking water should always be available to the animals, and the method of delivery
should be appropriate to the type of animal held. Troughs should be designed and installed in
such a way as to minimise the risk of fouling by faeces, without introducing risk of bruising and
injury in animals, and should not hinder the movement of animals.
d) Holding pens should be rectangular rather than square, to allow as many animals as possible to
stand or lie down against a wall. Where feed troughs are provided, they should be sufficient in
number and feeding space to allow adequate access of all animals to feed. The feed trough
should not hinder the movement of animals.
e) Where tethers, ties or individual stalls are used, these should be designed so as not to cause
injury or distress especially when the animals are lying down, standing up, drinking and feeding.
f) Passageways and races should be either straight or slightly curved, as appropriate to the animal
species. Passageways and races should have solid sides, but when there is a double race, the
shared partition should allow adjacent animals to see each other. For pigs and sheep,
passageways should be wide enough to enable two or more animals to walk side by side for as
long as possible. At the point where passageways are reduced in width, this should be done by a
means which prevents excessive bunching of the animals.
g) Animal handlers should be positioned alongside races and passageways on the inside radius of
any curve, to take advantage of the natural tendency of animals to circle an intruder. Where
one-way gates are used, they should be of a design which avoids bruising. Races should be
horizontal but where there is a slope, they should be constructed to allow the free movement of
animals without injury.
h) There should be a waiting pen, with a level floor and solid sides, between the holding pens and
the race leading to the point of stunning or slaughter, to ensure a steady supply of animals for
stunning or slaughter and to avoid having animal handlers trying to rush animals from the
holding pens. The waiting pen should preferably be circular, but in any case, so designed that
animals cannot be trapped or trampled.
i) Ramps or lifts should be used for loading and unloading of animals where there is a difference
in height or a gap between the floor of the vehicle and the unloading area. The ramp should be
well drained, non-slippery and adjustable to facilitate easy movement of animals without causing
distress or injury.
3. Construction of lairages
a) Lairages should be constructed and maintained so as to provide protection from unfavourable
climatic conditions, using strong and resistant materials such as concrete and metal which has
been treated to prevent corrosion. Surfaces should be easy to clean. There should be no sharp
edges or protuberances which may injure the animals.
b) Floors should be well drained and not slippery; they should not cause injury to the animals' feet.
Where necessary, floors should be insulated or provided with appropriate bedding. Drainage
grids should be placed at the sides of pens and passageways and not where animals would have
to cross them. Discontinuities or changes in floor patterns or texture which could cause
baulking in the movement of animals should be avoided.
c) Lairages should be provided with adequate lighting, but care should be taken to avoid harsh
lights and shadows, which frighten the animals or affect their movement. The fact that animals
will move more readily from a darker area into a well-lit area might be exploited by providing
for lighting that can be regulated accordingly.
d) Lairages should be well ventilated, and the air flow should be arranged so that odours and
draughts do not adversely affect the health and welfare of the animals.
e) Care should be taken to protect the animals from excessively or potentially disturbing noises,
for example by avoiding the use of noisy hydraulic or pneumatic equipment, and muffling noisy
metal equipment by the use of suitable padding, or by minimising the transmission of such
noise to the areas where animals are held and slaughtered.
f) Where animals are kept in outdoor lairages without natural shelter or shade, they should be
protected from the effects of adverse weather conditions.
Article 3.7.5.4.
Animals in lairages should be cared for in accordance with the following guidelines:
1. As far as possible, established groups of animals should be kept together. Each animal should have
enough space to stand up, lie down and turn around. Animals hostile to each other should be
separated.
2. Where tethers, ties or individual stalls are used, they should allow animals to stand up and lie down
without causing injury or distress.
3. Where bedding is provided, it should be maintained in a condition that minimises risks to the health
and safety of the animals, and sufficient bedding should be used so that animals do not become
soiled with manure.
4. Animals should be kept securely in the lairage, and care should be taken to prevent them from
escaping and from predators.
5. Suitable drinking water should be available to the animals on their arrival and at all times to animals
in lairages unless they are to be slaughtered without delay.
6. If animals are not to be slaughtered as soon as possible, suitable feed should be available to the
animals on arrival and at intervals appropriate to the species. Unweaned animals should be
slaughtered as soon as possible.
7. In order to prevent heat stress, animals subjected to high temperatures, particularly pigs and poultry,
should be cooled by the use of water sprays, fans or other suitable means.
8. The lairage area should be well lit in order to enable the animals to see clearly without being dazzled.
During the night, the lights should be dimmed.
9. The condition and state of health of the animals in a lairage should be inspected at least every
morning and evening by a veterinarian or, under the latter’s responsibility, by another competent
person. Animals which are sick, weak, injured or showing visible signs of distress should be treated
or humanely killed immediately.
10. Lactating dairy animals should be slaughtered as soon as possible. Dairy animals with obvious udder
distension should be milked to minimise udder discomfort.
11. Pregnant animals giving birth during the journey or in the lairage should be slaughtered as soon as
possible or provided with conditions which are appropriate for suckling and the welfare of the
newborn.
12. Animals with horns or tusks capable of injuring other animals, if aggressive, should be penned
separately.
Recommendations for specific species are described in detail in Articles 3.7.5.5. to 3.7.5.8.
Article 3.7.5.5.
body heat production because of foetal immaturity, and an increased incidence of infections due to a lack
of colostrum.
Article 3.7.5.6.
Summary of acceptable handling and restraining methods and the associated animal welfare
issues
Article 3.7.5.7.
Stunning methods
1. General considerations
The competence of the operators, and the appropriateness and effectiveness of the method used for
stunning are the responsibility of the management of the slaughterhouse, and should be checked
regularly by a Competent Authority.
Persons carrying out stunning should be properly trained and competent, and should ensure that:
a) the animal is adequately restrained;
b) animals in restraint are stunned as soon as possible;
c) the equipment used for stunning is maintained and operated properly in accordance with the
manufacturer's recommendations, in particular with regard to the species and size of the animal;
d) the instrument is applied correctly;
e) stunned animals are bled out (slaughtered) as soon as possible;
f) animals are not stunned when slaughter is likely to be delayed.
In addition, such persons should be able to recognise when an animal is not correctly stunned and
should take appropriate action.
2. Mechanical stunning
Cattle
The optimum position for cattle is at the intersection of two imaginary lines drawn from the rear of the
eyes to the opposite horn buds.
Pigs
The optimum position for pigs is just above the eyes and directing the shot down the line of the spinal
cord.
Sheep
The optimum position for hornless sheep and goats is on the midline, just above the eyes and directing
the shot down the line of the spinal cord.
Goats
The optimum position for heavily horned sheep and horned goats is behind the poll, aiming towards the
angle of the jaw.
Horses
Place the muzzle at right angles to the frontal surface well above the point where imaginary lines from eye
to ear cross.
Signs of correct stunning using a mechanical instrument are as follows:
a) the animal collapses immediately and does not attempt to stand up;
b) the body and muscles of the animal become tonic (rigid) immediately after the shot;
c) normal rhythmic breathing stops; and
d) the eyelid is open with the eyeball facing straight ahead and is not rotated.
3. Electrical stunning
a) General considerations
An electrical device should be applied to the animal in accordance with the following guidelines.
Electrodes should be designed, constructed, maintained and cleaned regularly to ensure that the
flow of current is optimal and in accordance to manufacturing specification. They should be
placed so that they span the brain. The application of electrical currents which bypass the brain
is unacceptable unless the animal has been stunned. The use of a single current leg-to-leg is
unacceptable as a stunning method.
If, in addition, it is intended to cause cardiac arrest, the electrodes should either span the brain
and immediately thereafter the heart, on the condition that it has been ascertained that the
animal is adequately stunned, or span brain and heart simultaneously.
Electrical stunning equipment should not be applied on animals as a means of guidance,
movement, restraint or immobilisation, and shall not deliver any shock to the animal before the
actual stunning or killing.
Electrical stunning apparatus should be tested prior to application on animals using appropriate
resistors or dummy loads to ensure the power output is adequate to stun animals.
The apparatus should incorporate a device which monitors and displays stunning current
delivered to the animals.
Appropriate measures, such as removing excess wool or wetting the skin only at the point of
contact, can be taken to minimise impedance of the skin and facilitate effective stunning.
The stunning apparatus required for electrical stunning should be provided with adequate
power to achieve continuously the minimum current level recommended for stunning as
indicate in the table below.
In all cases, the correct current level shall be attained within one second of the initiation of stun
and maintained at least for between one and three seconds and in accordance with the
manufacturer's instructions.
b) Electrical stunning of birds using a waterbath
In the case of birds suspended on a moving line, measures should be taken to ensure that the
birds are not wing flapping at the entrance of the stunner. The birds should be secure in their
shackle, but there should not be undue pressure on their shanks.
Waterbaths for poultry should be adequate in size and depth for the type of bird being
slaughtered, and their height should be adjustable to allow for the head of each bird to be
immersed. The electrode immersed in the bath should extend the full length of the waterbath.
Birds should be immersed in the bath up to the base of their wings.
The waterbath should be designed and maintained in such a way that when the shackles pass
over the water, they are in continuous contact with the earthed rubbing bar.
The control box for the waterbath stunner should incorporate an ammeter which displays the
total current flowing through the birds.
The shackle-to-leg contact should be wetted preferably before the birds are inserted in the
shackles. In order to improve electrical conductivity of the water it is recommended that salt be
added in the waterbath as necessary.
Using waterbaths, birds are stunned in groups and different birds will have different
impedances. The voltage should be adjusted so that the total current is the required current per
bird as shown in the table hereafter, multiplied by the number of birds in the waterbath at the
same time. The following values have been found to be satisfactory when employing a 50 Hertz
sinusoidal alternating current.
While a lower current may also be satisfactory, the current shall in any case be such as to ensure
that unconsciousness occurs immediately and lasts until the bird has been killed by cardiac
arrest or by bleeding. When higher electrical frequencies are used, higher currents may be
required.
Every effort shall be made to ensure that no conscious or live birds enter the scalding tank.
In the case of automatic systems, until fail-safe systems of stunning and bleeding have been
introduced, a manual back-up system should be in place to ensure that any birds which have
missed the waterbath stunner and/or the automatic neck-cutter are immediately stunned and/or
killed immediately, and they are dead before entering scald tank.
To lessen the number of unstunned birds, reaching neck cutters, steps should be taken to
ensure that small birds do not go on the line amongst bigger birds and that these small birds are
stunned separately.
4. Gas stunning
a) Stunning of pigs by exposure to carbon dioxide (CO2)
The concentration of CO2 for stunning should be preferably 90% by volume but in any case no
less than 80% by volume. After entering the stunning chamber, the animals should be conveyed
to the point of maximum concentration of the gas and be kept until they are dead or brought
into a state of insensibility which lasts until death occur due to bleeding. Ideally, pigs should be
exposed to this concentration of CO2 for 3 minutes.
In any case, the concentration of the gas should be such that it minimises as far as possible all
stress of the animal prior to loss of consciousness.
The chamber in which animals are exposed to CO2 and the equipment used for conveying them
through it shall be designed, constructed and maintained in such a way a to avoid injury or
unnecessary stress to the animals. The animal density within the chamber should be such to
avoid stacking animals on top of each others.
The conveyor and the chamber shall be adequately lit to allow the animals to see their
surroundings and, if possible, each other.
It should be possible to inspect the CO2 chamber whilst it is in use, and to have access to the
animals in emergency cases.
The chamber shall be equipped to continuously measure and display register at the point of
stunning the CO2 concentration and the time of exposure, and to give a clearly visible and
audible warning if the concentration of CO2 falls below the required level.
All animals should be bled by incising both carotid arteries, or the vessels from which they arise (e.g.
chest stick). However, when the stunning method used causes cardiac arrest, the incision of all of
these vessels is not necessary from the point of animal welfare.
It should be possible for staff to observe, inspect and access the animals throughout the bleeding
period. Any animal showing signs of recovering consciousness should be restunned.
After incision of the blood vessels, no scalding carcass treatment or dressing procedures should be
performed on the animals for at least 30 seconds, or in any case until all brain-stem reflexes have
ceased.
Article 3.7.5.8.
Summary of acceptable stunning methods and the associated animal welfare issues
Article 3.7.5.9.
Summary of acceptable slaughter methods and the associated animal welfare issues
Article 3.7.5.10.
1. The restraining methods which work through immobilisation by injury such as ‘puntilla’, breaking
legs and ‘leg tendon cutting’, cause severe pain and stress in animals. Those methods are not
acceptable in any species.
2. The use of the electrical stunning method with a single application leg to leg is ineffective and
unacceptable in any species, as it is likely to be painful. The animal welfare concerns are:
a) accidental pre-stun electric shocks;
b) inadequate current and voltage;
c) wrong electrode positioning;
d) recovery of consciousness.
3. The slaughter method of brain stem severance by piercing through the eye socket or skull bone is
not acceptable in any species.
Article 3.7.6.1.
General principles
This Appendix is based on the premise that a decision to kill the animals has been made.
1. All personnel involved in the humane killing of animals should have the relevant skills and
competencies.
2. As necessary, operational procedures should be adapted to the specific circumstances operating on
the premises and should address, apart from animal welfare, operator safety, biosecurity and
environmental aspects.
3. Following the decision to kill the animals, killing should be carried out as quickly as possible and
normal husbandry should be maintained until the animals are killed.
4. The handling and movement of animals should be minimised and when done, it should be done in
accordance with the guidelines described below.
5. Animal restraint should be sufficient to facilitate effective killing, and in accordance with animal
welfare and operator safety requirements; when restraint is required, killing should follow with
minimal delay.
6. When animals are killed for disease control purposes, methods used should result in immediate death
or immediate loss of consciousness lasting until death; when loss of consciousness is not immediate,
induction of unconsciousness should be non-aversive and should not cause anxiety, pain, distress or
suffering in the animals.
7. For animal welfare considerations, young animals should be killed before older animals; for
biosecurity considerations, infected animals should be killed first, followed by in-contact animals, and
then the remaining animals.
8. There should be continuous monitoring of the procedures to ensure they are consistently effective
with regard to animal welfare, operator safety and biosecurity.
9. When the operational procedures are concluded, there should be a written report describing the
practices adopted and their effect on animal welfare, operator safety and biosecurity.
10. To the extent possible to minimise public distress, killing of animals and carcass disposal should be
carried out away from public view.
11. These general principles should also apply when animals need to be killed for other purposes such as
after natural disasters.
Article 3.7.6.2.
Organisational structure
Disease control contingency plans should be in place at a national level and should contain details of
management structure, disease control strategies and operational procedures; animal welfare
considerations should be addressed within these disease control contingency plans. The plans should also
include a strategy to ensure that an adequate number of personnel trained in the humane killing of animals
is available.
Disease control contingency plans should address the animal welfare issues that may result from animal
movement controls.
The operational activities should be led by an official veterinarian who has the authority to appoint the
personnel in the specialist teams and ensure that they adhere to the required animal welfare and
biosecurity standards. When appointing the personnel, he/she should ensure that the personnel involved
has the required competencies.
The official veterinarian should be responsible for all activities across one or more affected premises and
should be supported by coordinators for planning (including communications), operations and logistics to
facilitate efficient operations.
The official veterinarian should provide overall guidance to personnel and logistic support for operations
on all affected premises to ensure consistency in adherence to the OIE animal welfare and animal health
guidelines.
A specialist team, led by a team leader answerable to the official veterinarian, should be deployed to work
on each affected premises. The team should consist of personnel with the competencies to conduct all
required operations; in some situations, personnel may be required to fulfil more than one function. Each
team should contain a veterinarian.
In considering the animal welfare issues associated with killing animals, the key personnel, their
responsibilities and competencies required are described in Article 3.7.6.3.
Article 3.7.6.3.
1. Team leader
a) Responsibilities
i) plan overall operations on an affected premises;
ii) determine and address requirements for animal welfare, operator safety and biosecurity;
iii) organise, brief and manage team of people to facilitate humane killing of the relevant
animals on the premises in accordance with national regulations and these guidelines;
iv) determine logistics required;
v) monitor operations to ensure animal welfare, operator safety and biosecurity requirements
are met;
vi) report upwards on progress and problems;
vii) provide a written report at the conclusion of the killing, describing the practices adopted
and their effect on animal welfare.
b) Competencies
i) appreciation of animal welfare and the underpinning behavioural, anatomical and
physiological processes involved in the killing process;
ii) skills to manage all activities on premises and deliver outcomes on time;
iii) awareness of psychological effects on farmer, team members and general public;
iv) effective communication skills.
2. Veterinarian
a) Responsibilities
i) determine and implement the most appropriate killing method to ensure that animals are
killed without avoidable pain and distress;
ii) determine and implement the additional requirements for animal welfare, including the
order of killing;
iii) minimise the risk of disease spread within and from the premises through the supervision
of biosecurity procedures;
iv) continuously monitor animal welfare and biosecurity procedures;
v) in cooperation with the leader, prepare a written report at the conclusion of the killing,
describing the practices adopted and their effect on animal welfare.
b) Competencies
i) ability to assess animal welfare, especially the effectiveness of stunning and killing and to
correct any deficiencies;
ii) ability to assess biosecurity risks.
3. Animal handlers
a) Responsibilities
i) review on-site facilities in terms of their appropriateness;
ii) design and construct temporary animal handling facilities, when required;
iii) move and restrain animals.
b) Competencies
An experience of animal handling in emergency situations and in close confinement is required.
4. Slaughterers
a) Responsibilities
A humane killing of animals through effective stunning and killing should be ensured.
b) Competencies
i) when required by regulations, licensed to use necessary equipment or licensed to be
slaughterers;
ii) competent to use and maintain relevant equipment;
iii) competent to use techniques for the species involved;
iv) competent to assess effective stunning and killing.
5. Carcass disposal personnel
a) Responsibilities
An efficient carcass disposal (to ensure killing operations are not hindered) should be ensured.
b) Competencies
The personnel should be competent to use and maintain available equipment and apply
techniques for the species involved.
6. Farmer/owner/manager
a) Responsibilities
i) assist when requested.
b) Competencies
i) specific knowledge of his/her animals and their environment.
Article 3.7.6.4.
Many activities will need to be conducted on affected premises, including the humane killing of animals.
The team leader should develop a plan for humanely killing animals on the premises which should include
consideration of:
1. minimising handling and movement of animals;
2. killing the animals on the affected premises; however, there may be circumstances where the animals
may need to be moved to another location for killing; when the killing is conducted at an abattoir,
the guidelines in the Chapter on slaughter of animal for human consumption should be followed;
3. the species, number, age and size of animals to be killed, and the order of killing them;
4. methods of killing the animals, and their cost;
5. housing and location of the animals;
6. the availability and effectiveness of equipment needed for killing of the animals;
7. the facilities available on the premises that will assist with the killing;
8. biosecurity and environmental issues;
9. the health and safety of personnel conducting the killing;
10. any legal issues that may be involved, for example where restricted veterinary drugs or poisons may
be used, or where the process may impact on the environment; and
11. the presence of other nearby premises holding animals.
In designing a killing plan, it is essential that the method chosen be consistently reliable to ensure that all
animals are humanely and quickly killed.
Article 3.7.6.5.
The methods are described in the order of mechanical, electrical and gaseous, not in an order of
desirability from an animal welfare viewpoint.
Article 3.7.6.6.
Free bullet
1. Introduction
a) A free bullet is a projectile fired from a shotgun, rifle, handgun or purpose-made humane killer.
b) The most commonly used firearms for close range use are:
i) humane killers (specially manufactured/adapted single-shot weapons);
ii) shotguns (12, 16, 20, 28 bore and .410);
iii) rifles (.22 rimfire);
iv) handguns (various calibres from .32 to .45).
c) The most commonly used firearms for long range use are rifles (.22, .243, .270 and .308).
d) A free bullet used from long range should be aimed to penetrate the skull or soft tissue at the
top of the neck of the animal, to cause irreversible concussion and death and should only be
used by properly trained and competent marksmen.
2. Requirements for effective use
a) The marksman should take account of human safety in the area in which he/she is operating.
b) The marksman should ensure that the animal is not moving and in the correct position to
enable accurate targeting and the range should be as short as possible (5 –50 cm for a shotgun)
but the barrel should not be in contact with the animal’s head.
c) The correct cartridge, calibre and type of bullet for the different species age and size should be
used. Ideally the ammunition should expand upon impact and dissipate its energy within the
cranium.
d) Shot animals should be checked to ensure the absence of brain stem reflexes.
3. Advantages
a) Used properly, a free bullet provides a quick and effective method for killing.
b) It requires minimal or no restraint and can be use to kill from a distance.
c) It is suitable for killing agitated animals in open spaces.
4. Disadvantages
a) The method is potentially dangerous to humans and other animals in the area.
b) It has the potential for non-lethal wounding.
c) Destruction of brain tissue may preclude diagnosis of some diseases.
d) Leakage of bodily fluids may present a biosecurity risk.
e) Legal requirements may preclude or restrict use.
f) There is a limited availability of competent personnel.
5. Conclusions
The method is suitable for cattle, sheep, goats and pigs, including large animals in open spaces.
Figure 1. The optimum shooting position for cattle is at the intersection of two imaginary lines drawn
from the rear of the eyes to the opposite horn buds.
Figure 2. The optimum shooting position for hornless sheep and goats is on the midline, just above the
eyes and directing the shot down the line of the spinal cord.
Figure 3. The optimum shooting position for heavily horned sheep and horned goats is behind the poll.
Figure 4. The optimum shooting position for pigs is just above the eyes and directing the shot down the
line of the spinal cord.
Article 3.7.6.7.
1. Introduction
A penetrating captive bolt is fired from a gun powered by either compressed air or a blank cartridge.
There is no free projectile.
The captive bolt should be aimed on the skull in a position to penetrate the cortex and mid-brain of
the animal. The impact of the bolt on the skull produces unconsciousness. Physical damage to the
brain caused by penetration of the bolt may result in death, however pithing or bleeding should be
performed as soon as possible after the shot to ensure the death of the animal.
2. Requirements for effective use
a) For cartridge powered and compressed air guns, the bolt velocity and the length of the bolt
should be appropriate to the species and type of animal, in accordance with the manufacturer’s
recommendations.
b) Captive bolt guns should be frequently cleaned and maintained in good working condition.
c) More than one gun may be necessary to avoid overheating and a back-up gun should be
available in the event of an ineffective shot.
d) Animals should be restrained; at a minimum they should be penned for cartridge powered guns
and in a race for compressed air guns.
e) The operator should ensure that the animal's head is accessible.
f) The operator should fire the captive bolt at right angles to the skull in the optimal position (see
figures 1, 3 & 4. The optimum shooting position for hornless sheep is on the highest point of
the head, on the midline and aim towards the angle of the jaw).
g) To ensure the death of the animal, pithing or bleeding should be performed as soon as possible
after stunning.
h) Animals should be monitored continuously after stunning until death to ensure the absence of
brain stem reflexes.
3. Advantages
a) Mobility of cartridge powered equipment reduces the need to move animals.
b) The method induces an immediate onset of a sustained period of unconsciousness.
4. Disadvantages
a) Poor gun maintenance and misfiring, and inaccurate gun positioning and orientation may result
in poor animal welfare.
Article 3.7.6.8.
1. Introduction
A non-penetrating captive bolt is fired from a gun powered by either compressed air or a blank
cartridge. There is no free projectile.
The gun should be placed on the front of the skull to deliver a percussive blow which produces
unconsciousness in cattle (adults only), sheep, goats and pigs, and death in poultry and neonate
sheep, goats and pigs. In mammals, bleeding should be performed as soon as possible after the blow
to ensure the death of the animal.
2. Requirements for effective use
a) For cartridge powered and compressed air guns, the bolt velocity should be appropriate to the
species and type of animal, in accordance with the manufacturer’s recommendations.
b) Captive bolt guns should be frequently cleaned and maintained in good working condition.
c) More than one gun may be necessary to avoid overheating and a back-up gun should be
available in the event of an ineffective shot.
d) Animals should be restrained; at a minimum mammals should be penned for cartridge powered
guns and in a race for compressed air guns; birds should be restrained in cones, shackles,
crushes or by hand.
e) The operator should ensure that the animal's head is accessible.
f) The operator should fire the captive bolt at right angles to the skull in the optimal position
(figures 1-4).
g) To ensure death in non-neonate mammals, bleeding should be performed as soon as possible
after stunning.
h) Animals should be monitored continuously after stunning until death to ensure the absence of
brain stem reflexes.
3. Advantages
a) The method induces an immediate onset of unconsciousness, and death in birds and neonates.
b) Mobility of equipment reduces the need to move animals.
4. Disadvantages
a) As consciousness can be regained quickly in non-neonate mammals, they should be bled as
soon as possible after stunning.
b) Laying hens in cages have to be removed from their cages and most birds have to be restrained.
c) Poor gun maintenance and misfiring, and inaccurate gun positioning and orientation may result
in poor animal welfare.
d) Post stun convulsions may make bleeding difficult and hazardous.
e) Difficult to apply in agitated animals; such animals may be sedated in advance of the killing
procedure.
f) Repeated use of a cartridge powered gun may result in over-heating.
g) Bleeding may present a biosecurity risk.
5. Conclusions
a) The method is suitable for poultry, and neonate sheep, goats and pigs.
b) If bleeding does not present a biosecurity issue, this is a suitable method for cattle (adults only),
and non-neonate sheep, goats and pigs.
Article 3.7.6.9.
Maceration
1. Introduction
Maceration, utilising a mechanical apparatus with rotating blades or projections, causes immediate
fragmentation and death in day-old poultry and embryonated eggs.
2. Requirements
a) Maceration requires specialised equipment which should be kept in excellent working order.
b) The rate of introducing the birds should not allow the equipment to jam, birds to rebound from
the blades or the birds to suffocate before they are macerated.
3. Advantages
a) Procedure results in immediate death.
b) Large numbers can be killed quickly.
4. Disadvantages
a) Specialised equipment is required.
b) Macerated tissues may present a biosecurity issue.
5. Conclusion
The method is suitable for killing day-old poultry and embryonated eggs.
Article 3.7.6.10.
1. Introduction
A two stage application of electric current comprises firstly an application of current to the head by
scissor-type tongs, immediately followed by an application of the tongs across the chest in a position
that spans the heart.
The application of sufficient electric current to the head will induce ‘tonic/clonic’ epilepsy and
unconsciousness. Once the animal is unconscious, the second stage will induce ventricular fibrillation
(cardiac arrest) resulting in death. The second stage (the application of low frequency current across
the chest) should only be applied to unconscious animals to prevent unacceptable levels of pain.
a) The stunner control device should generate a low frequency (30–60 Hz) current with a
minimum voltage of 250 volts true RMS under load.
b) Appropriate protective clothing (including rubber gloves and boots) should be worn.
d) Two team members are required, the first to apply the electrodes and the second to manipulate
the position of the animal to allow the second application to be made.
e) A stunning current should be applied via scissor-type stunning tongs in a position that spans the
brain for a minimum of 3 seconds; immediately following the application to the head, the
electrodes should be transferred to a position that spans the heart and the electrodes applied for
a minimum of 3 seconds.
f) Electrodes should be cleaned regularly and after use, to enable optimum electrical contact to be
maintained.
g) Animals should be monitored continuously after stunning until death to ensure the absence of
brain stem reflexes.
3. Advantages
a) The application of the second stage minimises post-stun convulsions and therefore the method
is particularly effective with pigs.
4. Disadvantages
b) The electrodes must be applied and maintained in the correct positions to produce an effective
stun and kill.
c) Most stunner control devices utilise low voltage impedance sensing as an electronic switch prior
to the application of high voltages; in unshorn sheep, contact impedance may be too high to
switch on the required high voltage (especially during stage two).
d) The procedure may be physically demanding, leading to operator fatigue and poor electrode
placement.
5. Conclusion
The method is suitable for calves, sheep and goats, and especially for pigs (over one week of age).
Article 3.7.6.11.
1. Method 1
Method 1 comprises the single application of sufficient electrical current to the head and back, to
simultaneously stun the animal and fibrillate the heart. Provided sufficient current is applied in a
position that spans both the brain and heart, the animal will not recover consciousness.
a) Requirements for effective use
i) The stunner control device should generate a low frequency (30–60 Hz) current with a
minimum voltage of 250 volts true RMS under load.
ii) Appropriate protective clothing (including rubber gloves and boots) should be worn.
iii) Animals should be individually and mechanically restrained close to an electrical supply as
the maintenance of physical contact between the stunning electrodes and the animal is
necessary for effective use.
iv) The rear electrode should be applied to the back, above or behind the heart, and then the
front electrode in a position that is forward of the eyes, with current applied for a
minimum of 3 seconds.
v) Electrodes should be cleaned regularly between animals and after use, to enable optimum
electrical contact to be maintained.
vi) Water or saline may be necessary to improve electrical contact with sheep.
vii) An effective stun and kill should be verified by the absence of brain stem reflexes.
b) Advantages
i) Method 1 stuns and kills simultaneously.
ii) It minimises post-stun convulsions and therefore is particularly effective with pigs.
iii) A single team member only is required for the application.
iv) Non-invasive technique minimises biosecurity risk.
c) Disadvantages
i) Method 1 requires individual mechanical animal restraint.
ii) The electrodes must be applied and maintained in the correct positions to produce an
effective stun and kill.
iii) Method 1 requires a reliable supply of electricity.
d) Conclusion
Method 1 is suitable for calves, sheep, goats, and pigs (over one week of age).
2. Method 2
Method 2 stuns and kills by drawing inverted and shackled poultry through an electrified waterbath
stunner. Electrical contact is made between the ‘live’ water and earthed shackle and, when sufficient
current is applied, poultry will be simultaneously stunned and killed.
a) Requirements for effective use
i) A mobile waterbath stunner and a short loop of processing line are required.
ii) A low frequency (30-60 Hz) current applied for a minimum of 3 seconds is necessary to
stun and kill the birds.
iii) Poultry need to be manually removed from their cage, house or yard, inverted and shackled
onto a line which conveys them through a waterbath stunner with their heads fully
immersed.
iv) The required minimum currents to stun and kill dry birds are:
- Quail - 100 mA/bird
- Chickens – 160 mA/bird
- Duck & Geese – 200 mA/bird
- Turkey – 250 mA/bird.
A higher current is required for wet birds.
v) An effective stun and kill should be verified by the absence of brain stem reflexes.
b) Advantages
i) Method 2 stuns and kills simultaneously.
ii) It is capable of processing large numbers of birds reliably and effectively.
iii) This non-invasive technique minimises biosecurity risk.
c) Disadvantages
i) Method 2 requires a reliable supply of electricity.
ii) Handling, inversion and shackling of birds are required.
d) Conclusion
Method 2 is suitable for large numbers of poultry.
3. Method 3
Method 3 comprises the single application of sufficient electrical current to the head of poultry in a
position that spans the brain, causing unconsciousness; this is followed by a killing method
(Article 3.7.6.17.).
a) Requirements for effective use
i) The stunner control device should generate sufficient current (more than 300 mA/bird) to
stun.
ii) Appropriate protective clothing (including rubber gloves and boots) should be worn.
iii) Birds should be restrained, at a minimum manually, close to an electrical supply.
iv) A stunning current should be applied in a position that spans the brain for a minimum of
3 seconds; immediately following this application, the birds should be killed
(Article 3.7.6.17.).
v) Electrodes should be cleaned regularly and after use, to enable optimum electrical contact
to be maintained.
vi) Birds should be monitored continuously after stunning until death to ensure the absence of
brain stem reflexes.
b) Advantages
Non-invasive technique (when combined with neck dislocation) minimises biosecurity risk.
c) Disadvantages
i) Method 3 requires a reliable supply of electricity.
ii) The electrodes must be applied and maintained in the correct position to produce an
effective stun.
d) Conclusion
Method 3 is suitable for small numbers of poultry.
Article 3.7.6.12.
1. Introduction
Controlled atmosphere killing is performed by exposing animals to a predetermined gas mixture,
either by placing them in a gas-filled container or apparatus (Method 1) or by the gas being
introduced into a poultry house (Method 2).
Inhalation of carbon dioxide (CO2) induces respiratory and metabolic acidosis and hence reduces the
pH of cerebrospinal fluid (CSF) and neurones thereby causing unconsciousness and, after prolonged
exposure, death.
2. Method 1
a) Requirements for effective use in a container or apparatus
i) Containers or apparatus should allow the required gas concentration to be maintained and
accurately measured.
ii) When animals are exposed to the gas individually or in small groups in a container or
apparatus, the equipment used should be designed, constructed, and maintained in such a
way as to avoid injury to the animals and allow them to be observed.
iii) Animals should be introduced into the container or apparatus after it has been filled with
the required CO2 concentration, and held in this atmosphere until death is confirmed.
iv) Team members should ensure that there is sufficient time allowed for each batch of
animals to die before subsequent ones are introduced into the container or apparatus.
v) Containers or apparatus should not be overcrowded and measures are needed to avoid
animals suffocating by climbing on top of each other.
b) Advantages
i) CO2 is readily available.
ii) Application methods are simple.
c) Disadvantages
i) The need for special equipment
ii) The aversive nature of high CO2 concentrations
iii) No immediate loss of consciousness
iv) The risk of suffocation due to overcrowding
v) Difficulty in verifying death while the animals are in the container or apparatus.
d) Conclusion
Method 1 is suitable for use in poultry and neonatal sheep, goats and pigs.
3. Method 2
a) Requirements for effective use in a poultry house
i) Prior to introduction of the CO2, the poultry house should be appropriately sealed to allow
control over the gas concentration.
ii) The house should be gradually filled with CO2 so that all birds are exposed to a
concentration of >40% until they are dead; a vaporiser may be required to prevent
freezing.
iii) Devices should be used to accurately measure the gas concentration at the highest level of
birds.
b) Advantages
i) Applying gas to birds in situ eliminates the need to manually remove live birds.
ii) CO2 is readily available.
iii) Gradual raising of CO2 concentration minimises the aversiveness of the induction of
unconsciousness.
c) Disadvantages
i) It is difficult to determine volume of gas required to achieve adequate concentrations of
CO2 in some poultry houses.
ii) It is difficult to verify death while the birds are in the poultry house.
d) Conclusion
Method 2 is suitable for use in poultry in closed-environment sheds.
Article 3.7.6.13.
1. Introduction
CO2 may be mixed in various proportions with nitrogen or an inert gas eg argon, and the inhalation
of such mixtures leads to hypercapnic-hypoxia and death when the oxygen concentration by volume
is ?2%. This method involves the introduction of animals into a container or apparatus containing
the gases. Such mixtures do not induce immediate loss of consciousness, therefore the aversiveness
of various gas mixtures containing high concentrations of CO2 and the respiratory distress occurring
during the induction phase, are important animal welfare considerations.
Pigs and poultry appear not to find low concentrations of CO2 strongly aversive, and a mixture of
nitrogen or argon with <30% CO2 by volume and <2% O2 by volume can be used for killing
poultry and neonatal sheep, goats and pigs.
2. Requirements for effective use
a) Containers or apparatus should allow the required gas concentrations to be maintained, and the
O2 and CO2 concentrations accurately measured.
b) When animals are exposed to the gases individually or in small groups in a container or
apparatus, the equipment used should be designed, constructed, and maintained in such a way
as to avoid injury to the animals and allow them to be observed.
c) Animals should be introduced into the container or apparatus after it has been filled with the
required gas concentrations (with <2% O2), and held in this atmosphere until death is
confirmed.
d) Team members should ensure that there is sufficient time allowed for each batch of animals to
die before subsequent ones are introduced into the container or apparatus.
e) Containers or apparatus should not be overcrowded and measures are needed to avoid animals
suffocating by climbing on top of each other.
3. Advantages
Low concentrations of CO2 cause little aversiveness and, in combination with nitrogen or an inert
gas, produces a fast induction of unconsciousness.
4. Disadvantages
a) A properly designed container or apparatus is needed.
b) It is difficult to verify death while the animals are in the container or apparatus.
c) There is no immediate loss of consciousness.
d) Exposure times required to kill are considerable.
5. Conclusion
The method is suitable for poultry and neonatal sheep, goats and pigs.
Article 3.7.6.14.
1. Introduction
This method involves the introduction of animals into a container or apparatus containing nitrogen
or an inert gas such as argon. The controlled atmosphere produced leads to unconsciousness and
death from hypoxia.
Research has shown that hypoxia is not aversive to pigs and poultry, and it doesn’t induce any signs
of respiratory distress prior to loss of consciousness.
2. Requirements for effective use
a) Containers or apparatus should allow the required gas concentrations to be maintained, and the
O2 concentration accurately measured.
b) When animals are exposed to the gases individually or in small groups in a container or
apparatus, the equipment used should be designed, constructed, and maintained in such a way
as to avoid injury to the animals and allow them to be observed.
c) Animals should be introduced into the container or apparatus after it has been filled with the
required gas concentrations (with <2% O2), and held in this atmosphere until death is
confirmed.
d) Team members should ensure that there is sufficient time allowed for each batch of animals to
die before subsequent ones are introduced into the container or apparatus.
e) Containers or apparatus should not be overcrowded and measures are needed to avoid animals
suffocating by climbing on top of each other.
3. Advantages
Animals are unable to detect nitrogen or inert gases, and the induction of hypoxia by this method is
not aversive to animals.
4. Disadvantages
a) A properly designed container or apparatus is needed.
b) It is difficult to verify death while the animals are in the container or apparatus.
c) There is no immediate loss of consciousness.
d) Exposure times required to kill are considerable.
5. Conclusion
The method is suitable for poultry and neonatal sheep, goats and pigs.
Article 3.7.6.15.
Lethal injection
1. Introduction
A lethal injection using high doses of anaesthetic and sedative drugs causes CNS depression,
unconsciousness and death. In practice, barbiturates in combination with other drugs are commonly
used.
2. Requirements for effective use
a) Doses and routes of administration that cause rapid loss of consciousness followed by death
should be used.
b) Prior sedation may be necessary for some animals.
c) Intravenous administration is preferred, but intraperitoneal or intramuscular administration may
be appropriate, especially if the agent is non-irritating.
d) Animals should be restrained to allow effective administration.
e) Animals should be monitored to ensure the absence of brain stem reflexes.
3. Advantages
a) The method can be used in all species.
b) Death can be induced smoothly.
4. Disadvantages
a) Restraint and/or sedation may be necessary prior to injection.
b) Some combinations of drug type and route of administration may be painful, and should only
be used in unconscious animals.
c) Legal requirements may restrict use to veterinarians.
5. Conclusion
The method is suitable for killing small numbers of cattle, sheep, goats, pigs and poultry.
Article 3.7.6.16.
1. Introduction
An anaesthetic agent which can be mixed with poultry feed or water may be used to kill poultry in
houses. Poultry which are only anaesthetised need to be killed by another method such as cervical
dislocation.
2. Requirements for effective use
a) Sufficient quantities of anaesthetic need to be ingested rapidly for effective response.
b) Intake of sufficient quantities is facilitated if the birds are fasted or water is withheld.
c) Must be followed by killing (see Article 3.7.6.17.) if birds are anaesthetised only.
3. Advantages
a) Handling is not required until birds are anaesthetised.
b) There may be biosecurity advantages in the case of large numbers of diseased birds.
4. Disadvantages
a) Non-target animals may accidentally access the medicated feed or water when provided in an
open environment.
b) Dose taken is unable to be regulated and variable results may be obtained..
c) Animals may reject adulterated feed or water due to illness or adverse flavour.
d) The method may need to be followed by killing.
e) Care is essential in the preparation and provision of treated feed or water, and in the disposal of
uneaten treated feed/water and contaminated carcasses.
5. Conclusion
The method is suitable for killing large numbers of poultry in houses.
Article 3.7.6.17.
1 The only preclusion against the use of this method for neonates is the design of the stunning
tongs that may not facilitate their application across such a small-sized head/body.
APPENDIX 3.8.1.
Article 3.8.1.1.
1. In general, surveillance is aimed at demonstrating the absence of disease or infection, determining the
occurrence or distribution of disease or infection, while also detecting as early as possible exotic or
emerging diseases. The type of surveillance applied depends on the desired outputs needed to support
decision-making. The following guidelines may be applied to all diseases, their agents and susceptible
species as listed in the Terrestrial Code, and are designed to assist with the development of
surveillance methodologies. Except where a specific surveillance method for a certain disease or
infection is already described in the Terrestrial Code, the guidelines in this Appendix may be used to
further refine the general approaches described for a specific disease or infection. Where detailed
disease/infection-specific information is not available, suitable approaches should be based on the
guidelines in this Appendix.
2. Animal health surveillance is an essential component necessary to detect diseases, to monitor disease
trends, to control endemic and exotic diseases, to support claims for freedom from disease or infection,
to provide data to support the risk analysis process, for both animal health and/or public health
purposes, and to substantiate the rationale for sanitary measures. Surveillance data underpin the
quality of disease status reports and should satisfy information requirements for accurate risk analysis
both for international trade as well as for national decision-making.
3. Essential prerequisites to enable a Member Country to provide information for the evaluation of its
animal health status are:
a) that the particular Member Country complies with the provisions of Chapter 1.3.3. of the
Terrestrial Code on the quality and evaluation of the Veterinary Services;
b) that, where possible, surveillance data be complemented by other sources of information (e.g.
scientific publications, research data, documented field observations and other non-survey data);
c) that transparency in the planning and execution of surveillance activities and the analysis and
availability of data and information, be maintained at all times, in accordance with Chapter 1.1.2.
of the Terrestrial Code.
4. The objectives of this Appendix are to:
a) provide guidance to the type of outputs that a surveillance system should generate;
b) provide guidelines to assess the quality of disease surveillance systems.
Article 3.8.1.2.
Definitions
Test: A procedure used to classify a unit as either positive, negative or suspect with respect to an infection
or disease.
Test system: A combination of multiple tests and rules of interpretation which are used for the same
purpose as a test.
Article 3.8.1.3.
Principles of surveillance
1. Types of surveillance
a) Surveillance may be based on many different data sources and can be classified in a number of
ways, including:
i) the means by which data are collected (active versus passive surveillance);
ii) the disease focus (pathogen-specific versus general surveillance); and
iii) the way in which units for observation are selected (structured surveys versus non-random
data sources).
b) In this Appendix, surveillance activities are classified as being based on:
EITHER
i) structured population-based surveys, such as:
- systematic sampling at slaughter;
- random surveys;
OR
ii) structured non-random surveillance activities, such as:
- disease reporting or notifications;
- control programmes/health schemes;
- targeted testing/screening;
- ante-mortem and post-mortem inspections;
- laboratory investigation records;
- biological specimen banks;
- sentinel units;
- field observations;
- farm production records.
c) In addition, surveillance data should be supported by related information, such as:
i) data on the epidemiology of the infection, including environmental, host population
distribution, and climatic information;
ii) data on animal movements and trading patterns for animals and animal products;
iii) national animal health regulations, including information on compliance with them and
their effectiveness;
iv) history of imports of potentially infected material; and
v) biosecurity measures in place.
d) The sources of evidence should be fully described. In the case of a structured survey, this
should include a description of the sampling strategy used for the selection of units for testing.
For structured non-random data sources, a full description of the system is required including
the source(s) of the data, when the data were collected, and a consideration of any biases that
may be inherent in the system.
2. Critical elements
In assessing the quality of a surveillance system, the following critical elements need to be addressed
over and above quality of Veterinary Services (Chapter 1.3.3.).
a) Populations
Ideally, surveillance should be carried out in such a way as to take into account all animal species
susceptible to the infection in a country, zone or compartment. The surveillance activity may cover
all individuals in the population or part of them. When surveillance is conducted only on a
subpopulation, care should be taken regarding the inferences made from the results.
Definitions of appropriate populations should be based on the specific recommendations of the
disease chapters of the Terrestrial Code.
b) Epidemiological unit
The relevant epidemiological unit for the surveillance system should be defined and documented
to ensure that it is representative of the population. Therefore, it should be chosen taking into
account factors such as carriers, reservoirs, vectors, immune status, genetic resistance and age,
sex, and other host criteria.
c) Clustering
Infection in a country, zone or compartment usually clusters rather than being uniformly or
randomly distributed through a population. Clustering may occur at a number of different levels
(e.g. a cluster of infected animals within a herd, a cluster of pens in a building, or a cluster of
farms in a compartment). Clustering should be taken into account in the design of surveillance
activities and the statistical analysis of surveillance data, at least at what is judged to be the most
significant level of clustering for the particular animal population and infection.
d) Case and outbreak definitions
Clear and unambiguous case and outbreak definitions should be developed and documented for
each pathogen under surveillance, using, where they exist, the standards in the Terrestrial Code.
e) Analytical methodologies
Surveillance data should be analysed using appropriate methodologies, and at the appropriate
organisational levels to facilitate effective decision making, whether it be planning interventions
or demonstrating status.
Methodologies for the analysis of surveillance data should be flexible to deal with the
complexity of real life situations. No single method is applicable in all cases. Different
methodologies may be needed to accommodate the relevant pathogens, varying production and
surveillance systems, and types and amounts of data and information available.
The methodology used should be based on the best available information that is in accord with
current scientific thinking. The methodology should be in accordance with this Appendix and
fully documented, and supported by reference to the scientific literature and other sources,
including expert opinion. Sophisticated mathematical or statistical analyses should only be
carried out when justified by the proper amount and quality of field data.
Consistency in the application of different methodologies should be encouraged and
transparency is essential in order to ensure fairness and rationality, consistency in decision
making and ease of understanding. The uncertainties, assumptions made, and the effect of these
on the final conclusions should be documented.
f) Testing
Surveillance involves the detection of disease or infection by the use of appropriate case
definitions based on the results of one or more tests for evidence of infection or immune status.
In this context, a test may range from detailed laboratory examinations to field observations and
the analysis of production records. The performance of a test at the population level (including
field observations) may be described in terms of its sensitivity and specificity and predictive
values. Imperfect sensitivity and/or specificity will have an impact on the conclusions from
surveillance. Therefore, these parameters should be taken into account in the design of
surveillance systems and analysis of surveillance data.
The values of sensitivity and specificity for the tests used should be specified, and the method
used to determine or estimate these values should be documented. Alternatively, where values
for sensitivity and/or specificity for a particular test are specified in the Terrestrial Manual, these
values may be used as a guide.
Samples from a number of animals or units may be pooled and subjected to a testing protocol.
The results should be interpreted using sensitivity and specificity values that have been
determined or estimated for that particular pool size and testing procedure.
g) Quality assurance
Surveillance systems should incorporate the principles of quality assurance and be subjected to
periodic auditing to ensure that all components of the system function and provide verifiable
documentation of procedures and basic checks to detect significant deviations of procedures
from those documented in the design.
h) Validation
Results from animal health surveillance systems are subject to one or more potential biases.
When assessing the results, care should be taken to identify potential biases that can
inadvertently lead to an over-estimate or an under-estimate of the parameters of interest.
The success of a surveillance system is dependent on a reliable process for data collection and
management. The process may be based on paper records or computerised. Even where data
are collected for non-survey purposes (e.g. during disease control interventions, inspections for
movement control or during disease eradication schemes), the consistency and quality of data
collection and event reporting in a format that facilitates analysis, is critical. Factors influencing
the quality of collected data include:
- the distribution of, and communication between, those involved in generating and
transferring data from the field to a centralised location;
- the ability of the data processing system to detect missing, inconsistent or inaccurate data,
and to address these problems;
Article 3.8.1.4.
In addition to the principles for surveillance discussed above, the following guidelines should be used
when planning, implementing and analysing surveys.
1. Types of surveys
Surveys may be conducted on the entire target population (i.e. a census) or on a sample. A sample
may be selected in either of the two following ways:
a) non-probability based sampling methods, such as:
i) convenience;
ii) expert choice;
iii) quota;
b) probability based sampling methods, such as:
i) simple random selection;
ii) cluster sampling;
iii) stratified sampling;
iv) systematic sampling.
Non-probability based sampling methods will not be discussed further.
Periodic or repeated surveys conducted in order to document disease freedom should be done using
probability based sampling methods so that data from the study population can be extrapolated to
the target population in a statistically valid manner.
The sources of information should be fully described and should include a detailed description of the
sampling strategy used for the selection of units for testing. Also, consideration should be made of
any biases that may be inherent in the survey design.
2. Survey design
The population of epidemiological units should first be clearly defined; hereafter sampling units
appropriate for each stage, depending on the design of the survey, should be defined.
The design of the survey will depend on the size and structure of the population being studied, the
epidemiology of the infection and the resources available.
3. Sampling
The objective of sampling from a population is to select a subset of units from the population that is
representative of the population with respect to the object of the study such as the presence or
absence of infection. Sampling should be carried out in such a way as to provide the best likelihood
that the sample will be representative of the population, within the practical constraints imposed by
different environments and production systems. In order to detect the presence of an infection in a
population of unknown disease status, targeted sampling methods that optimise the detection of
infection can be used. In such cases, care should be taken regarding the inferences made from the
results.
4. Sampling methods
When selecting epidemiological units from within a population, probability sampling (e.g. simple
random selection) should be used. When this is not possible, sampling should provide the best
practical chance of generating a sample that is representative of the target population.
In any case, the sampling method used at all stages should be fully documented and justified.
5. Sample size
In general, surveys are conducted either to demonstrate the presence or absence of a factor (e.g.
infection) or to estimate a parameter (e.g. the prevalence of infection). The method used to calculate
sample size for surveys depends on the purpose of the survey, the expected prevalence, the level of
confidence desired of the survey results and the performance of the tests used.
Article 3.8.1.5.
Surveillance systems routinely use structured non-random data, either alone or in combination with
surveys.
1. Common non-random surveillance sources
A wide variety of non-random surveillance sources may be available. These vary in their primary
purpose and the type of surveillance information they are able to provide. Some surveillance systems
are primarily established as early detection systems, but may also provide valuable information to
demonstrate freedom from infection. Other systems provide cross-sectional information suitable for
prevalence estimation, either once or repeatedly, while yet others provide continuous information,
suitable for the estimate of incidence data (e.g. disease reporting systems, sentinel sites, testing
schemes). Surveillance systems routinely use structured non-random data, either alone or in
combination with surveys.
a) Disease reporting or notification systems
Data derived from disease reporting systems can be used in combination with other data
sources to substantiate claims of animal health status, to generate data for risk analysis, or for
early detection. Effective laboratory support is an important component of any reporting
system. Reporting systems relying on laboratory confirmation of suspect clinical cases should
use tests that have a high specificity. Reports should be released by the laboratory in a timely
manner, with the amount of time from disease detection to report generation minimized (to
hours in the case of introduction of a foreign animal disease).
b) Control programmes / health schemes
Animal disease control programmes or health schemes, while focusing on the control or
eradication of specific diseases, should be planned and structured in such a manner as to
generate data that are scientifically verifiable and contribute to structured surveillance.
c) Targeted testing / screening
This may involve testing targeted to selected sections of the population (subpopulations), in
which disease is more likely to be introduced or found. Examples include testing culled and
dead animals, swill fed animals, those exhibiting clinical signs, animals located in a defined
geographic area and specific age or commodity group.
d) Ante-mortem and post-mortem inspections
Inspections of animals at abattoirs may provide valuable surveillance data. The sensitivity and
specificity of the particular slaughterhouse inspection system for detecting the presence of
infectious agents of surveillance interest under the particular inspection arrangements applying
in a country should be pre-determined by the Competent Authority if the data is to be fully
utilised. The accuracy of the inspection system will be influenced by:
i) the level of training and experience of the staff doing the inspections, and the ratio of staff
of different levels of training;
ii) the involvement of the Competent Authorities in the supervision of ante-mortem and
post-mortem inspections;
iii) the quality of construction of the abattoir, speed of the slaughter chain, lighting quality, etc;
and
iv) staff morale/motivation for accurate and efficient performance.
Abattoir inspections are likely to provide good coverage only for particular age groups and
geographical areas. Abattoir surveillance data are subject to obvious biases in relation to target
and study populations (e.g. only animals of a particular class and age may be slaughtered for
human consumption in significant numbers). Such biases need to be recognized when analysing
surveillance data.
Both for traceback in the event of detection of disease and for analysis of spatial and herd-level
coverage, there should be, if possible, an effective identification system that relates each animal
in the abattoir to its locality of origin.
e) Laboratory investigation records
Analysis of laboratory investigation records may provide useful surveillance information. The
coverage of the system will be increased if analysis is able to incorporate records from national,
accredited, university and private sector laboratories. Valid analysis of data from different
laboratories depends on the existence of standardised diagnostic procedures and standardised
methods for interpretation and data recording. As with abattoir inspections, there needs to be a
mechanism to relate specimens to the farm of origin.
f) Biological specimen banks
Specimen banks consist of stored specimens, gathered either through representative sampling
or opportunistic collection or both. Specimen banks may contribute to retrospective studies,
including providing support for claims of historical freedom from infection, and may allow
certain studies to be conducted more quickly and at lower cost than alternative approaches.
g) Sentinel units
Sentinel units/sites involve the identification and regular testing of one or more of animals of
known health/immune status in a specified geographical location to detect the occurrence of
disease (usually serologically). They are particularly useful for surveillance of diseases with a
strong spatial component, such as vector-borne diseases. Sentinel units provide the opportunity
to target surveillance depending on the likelihood of infection (related to vector habitats and
host population distribution), cost and other practical constraints. Sentinel units may provide
evidence of freedom from infection, or provide data on prevalence and incidence as well as the
distribution of disease.
h) Field observations
Clinical observations of animals in the field are an important source of surveillance data. The
sensitivity and specificity of field observations may be relatively low, but these can be more
easily determined and controlled if a clear, unambiguous and easy to apply standardised case
definition is applied. Education of potential field observers in application of the case definition
and reporting is an important component. Ideally, both the number of positive observations
and the total number of observations should be recorded.
i) Farm production records
Systematic analysis of farm production records may be used as an indicator of the presence or
absence of disease at the herd or flock level. In general, the sensitivity of this approach may be
quite high (depending on the disease), but the specificity is often quite low.
2. Critical elements for structured non-random surveillance
There is a number of critical factors which should be taken into account when using structured
non-random surveillance data such as coverage of the population, duplication of data, and sensitivity
and specificity of tests that may give rise to difficulties in the interpretation of data. Surveillance data
from non-random data sources may increase the level of confidence or be able to detect a lower level
of prevalence with the same level of confidence compared to structured surveys.
3. Analytical methodologies
Different methodologies may be used for the analysis of non-random surveillance data.
Different scientifically valid methodologies may be used for the analysis of non-random surveillance
data. Where no data are available, estimates based on expert opinions, gathered and combined using
a formal, documented and scientifically valid methodology may be used.
4. Combination of multiple sources of data
The methodology used to combine the evidence from multiple data sources should be scientifically
valid, and fully documented including references to published material.
Surveillance information gathered from the same country, zone or compartment at different times may
provide cumulative evidence of animal health status. Such evidence gathered over time may be
combined to provide an overall level of confidence. For instance, repeated annual surveys may be
analysed to provide a cumulative level of confidence. However, a single larger survey, or the
combination of data collected during the same time period from multiple random or non-random
sources, may be able to achieve the same level of confidence in just one year.
Analysis of surveillance information gathered intermittently or continuously over time should, where
possible, incorporate the time of collection of the information to take the decreased value of older
information into account. The sensitivity, specificity and completeness of data from each source
should also be taken into account for the final overall confidence level estimation.
Article 3.8.1.6.
Freedom from infection implies the absence of the pathogenic agent in the country, zone or
compartment. Scientific methods cannot provide absolute certainty of the absence of infection.
Demonstrating freedom from infection involves providing sufficient evidence to demonstrate (to a
level of confidence acceptable to Member Countries) that infection with a specified pathogen is not
present in a population. In practice, it is not possible to prove (i.e., be 100% confident) that a
population is free from infection (unless every member of the population is examined simultaneously
with a perfect test with both sensitivity and specificity equal to 100%). Instead, the aim is to provide
adequate evidence (to an acceptable level of confidence), that infection, if present, is present in less
than a specified proportion of the population.
However, finding evidence of infection at any level in the target population automatically invalidates
any freedom from infection claim unless otherwise stated in the relevant disease Chapter.
Evidence from targeted, random or non-random data sources, as stated before, may increase the
level of confidence or be able to detect a lower level of prevalence with the same level of confidence
compared to structured surveys.
Article 3.8.1.7.
Surveillance to determine distribution and occurrence of infection or of other relevant health related
events is widely used to assess progress in the control or eradication of selected diseases and pathogens
and as an aid to decision making. It has, however, relevance for the international movement of animals
and products when movement occurs among infected countries.
In contrast to surveillance to demonstrate freedom from infection, surveillance used to assess progress in
control or eradication of selected diseases and pathogens is usually designed to collect data about a
number of variables of animal health relevance, for example:
7. frequency distribution of the number o days elapsing between suspicion of infection and laborator
confirmation of the diagnosis and/or to the adoption of control measures;
vi) all clinical evidence suggestive of rinderpest within the zone is investigated by field and
laboratory methods (including serological assessment) to refute a possible diagnosis of
rinderpest;
vii) there are effective measures in force to prevent the re-introduction of the disease into the
zone from the remainder of the country and from other countries.
The declaration of zones to be free from rinderpest will not remove the requirement for the
country to subsequently meet the criteria for declaration of freedom from rinderpest disease for
the country as a whole; if it wishes to achieve that status, it will have to meet all the
requirements specified earlier before it can apply for a declaration of freedom from rinderpest
disease for the entire country.
Should there be a localised temporary outbreak of disease due to re-introduction of rinderpest
to a country or zone which is within 2 years of meeting the requirements for declaration of
freedom fromrinderpest disease, that country may take special measures (including intensive
perifocal vaccination) to eradicate the outbreak. In such circumstances, it will then require at
least one year from the date of the last case or the last vaccination (whichever occurs later)
before the country or zone becomes eligible to apply for a declaration of freedom from
rinderpest disease.
In making such an application under these special circumstances, the country must satisfy the
OIE Scientific Commission for Animal Diseases that the outbreak did not represent endemic
infection and that the disease has been eradicated by the actions taken.
c) Freedom from rinderpest infection
A country which has not vaccinated against rinderpest for at least 10 years and has throughout
that period had no evidence of rinderpest disease or rinderpest virus infection may be declared
free from rinderpest infection by the OIE based on conclusions of the OIE Scientific
Commission for Animal Diseases, provided that the country has had throughout that period
and maintains permanently an adequate disease reporting system.
OR
A country which has either vaccinated against rinderpest within the last 10 years or has had
clinical evidence of rinderpest, may be declared by the OIE to be free from rinderpest infection
if the following criteria are met:
i) it should have been declared free from rinderpest disease at least one year earlier, and
continues to meet the requirements for this status;
ii) there should have been an effective serosurveillance system in operation for a period of at
least 2 years, and the findings must have been consistent with freedom from infection.
This serosurveillance must include other susceptible domestic stock in addition to cattle;
iii) investigations into infection in wild susceptible species must be carried out where these
species occur in significant numbers. Where there are opportunities, sampling should be
done when possible. Additional strategic sampling of domestic stock should be done in
areas adjacent to large game populations to enhance the possibilities of detecting the
presence of virus in the game. The findings must be consistent with freedom from
infection.
On meeting these criteria, a country may apply to the OIE to be declared free from rinderpest
infection.
Declaration of freedom from rinderpest infection can only be made for the country as a whole,
and not for zones within a country.
Should there be a localised, temporary outbreak of disease due to re-introduction of rinderpest
to a country which is within one year of meeting the requirements for declaration of freedom
from rinderpest infection, that country may take special measures to stamp out the outbreak
(excluding the use of vaccine). In such circumstances, the country must wait at least one year
from the date of the last case before it becomes eligible to apply for declaration of freedom
from rinderpest infection. During this year there should be an effective sero-surveillance system
in operation in order to prove that the virus has not been disseminated.
In making such an application under these special circumstances, the country must satisfy the
OIE Scientific Commission for Animal Diseases that the outbreak did not represent endemic
infection and that the disease has been eradicated by the actions taken.
In order to maintain this status, the country must continue to operate an efficient disease
reporting system which would detect rinderpest if it occurred.
Fig. 1. Requirements for the declaration of freedom from rinderpest disease and
freedom from rinderpest infection
°If a country wants to be declared free from rinderpest infection at the end of year 4, serological
surveillance of unvaccinated animals must be in operation at the end of year 2, in order to prove that
there has been no sero-positive case in the country for at least 2 years.
4. Epidemiological methods
a) Definition of sampling units
A sampling unit for the purposes of disease investigation and surveillance is defined as a group
of animals in sufficiently close contact that individuals within the group are at approximately
equal risk of coming in contact with the virus if there should be an infectious animal within the
group In most circumstances, the sampling unit will be a herd which is managed as a unit by an
individual or a community, but it may also be other epidemiologically appropriate groupings
which are subject to regular mixing, such as all animals belonging to residents of a village. In the
areas where nomadic or transhumant movements exist, the sampling unit can be the permanent
bore holes, wells or waterpoints. Sampling units should normally be defined so that their size is
not less than 50 animals or more than 1,000.
b) Criteria for stratification of host populations
Any disease surveillance activities must be conducted on populations stratified according to the
management system, and by herd size where this is variable. Herds, or other sampling units,
should be selected by proper random statistical selection procedures from each stratum.
The composition and method of selection of the Expert Panel shall be such as to ensure both a high
level of expertise in evaluating the evidence and total independence of the Panel in reaching
conclusions concerning the disease status of a particular country.
SURVEILLANCE
FOR CONTAGIOUS BOVINE PLEUROPNEUMONIA
1. Introduction
The Ad hoc Group on Contagious Bovine Pleuropneumonia (CBPP) Surveillance Systems held a
meeting on 7-9 June 1993 with the purpose of formulating these standards, which describe
surveillance systems suited to the declaration of countries and zones free of disease and free of
infection. Background information is contained in the report of the meeting. In order to write these
standards, the Group reviewed the following:
a) epidemiological and non-disease factors influencing the choice of CBPP surveillance systems;
b) sampling and surveillance strategies;
c) diagnostic methods applicable to CBPP surveillance systems;
d) the implications of CBPP vaccination for surveillance systems.
This last point was the subject of lengthy discussions during the meeting of the OIE Committee in
May 1994. A revised text was submitted at the following meeting of the Committee (May 1995),
which requested that a small group of experts formulate revised proposals. The present text is the
product of their consensus.
2. Definition and purposes of surveillance
Disease surveillance is necessary to provide evidence that a country or zone is free from a disease or
infection.
Disease surveillance should be implemented by both:
a) a system of reporting any signs of disease activity which come to the notice of Veterinary
Services or livestock owners; and,
b) an active programme of examination of statistically selected samples from host populations in
order to detect clinical signs or other indications of the occurrence of disease or transmission of
infection.
In either case, suspicion of disease activity should be followed by quarantine, confirmatory diagnostic
work and any necessary disease control measures. Surveillance thus implies that official action will
follow from the discovery of evidence of disease or infection. It can be contrasted with monitoring,
in which the gathering of data from the field takes place similarly, but no official action based on the
findings is implied in the data-gathering activity.
Within the context of pleuropneumonia, specific measures need to be implemented, such as an
exhaustive inspection of all lungs of bovines throughout the country or zone.
3. Steps to be taken to declare a country free from contagious bovine pleuropneumonia
The current goal in CBPP control is to achieve freedom from disease in particular countries and later
of entire world regions, with the ultimate aim of achieving global eradication. It is therefore
necessary to institute a system for verifying the steps towards these short and long-term aims, and to
assist countries which wish to trade in livestock or livestock products, but face difficulties due to the
presence or past occurrence of CBPP.
In conformity with the general principles for assessing disease status developed by the OIE, a
four-stage process should be applied:
- intention to eradicate pleuropneumonia: the longest phase, depending on prevalence of the
disease in the country or zone, geographical, socio-economic and administrative conditions, and
the capacity of the animal health infrastructure.
- once a country is free from CBPP and that disease is unlikely to be re-introduced, the country
can declare itself provisionally free from disease, provided it meets the criteria listed below;
- declaration of freedom from clinical CBPP, after international verification carried out under the
auspices of the OIE;
- declaration of freedom from CBPP, where a country meets more stringent surveillance and
control criteria.
The last three stages are strictly covered by the epidemiological surveillance methods of the OIE.
The sequence of operations differs both in terms of tactics and duration depending on whether or
not the country wishing to eradicate CBPP practises vaccination.
'Disease' in the context of declaration of freedom means that the particular pathogenic agent is
present and causes significant pathological effects on animals which become infected with the agent.
Thus 'freedom from disease' means that there is no evidence in animals within the country or zone
of any pathological effects occurring (including clinical signs) due to the presence of the agent, and
from all the evidence pathogenic strains of the particular agent have been eliminated.
COUNTRIES PRACTISING VACCINATION
The process is summarised in the following chart:
Fig. 1. Requirements for the declaration of freedom from disease and freedom from CBPP
The specific criteria proposed for each stage of this process are as follows:
a) Provisional freedom from disease
For a country to declare the whole or a zone of its territory provisionally free from disease, it
must fulfil certain conditions, which are:
i) no clinical or pathological evidence of CBPP should have been detected for at least 3 years;
ii) there is an effective Veterinary Service which is able to monitor the animal health situation
in the country;
iii) there is effective meat inspection at approved abattoirs, and effective surveillance of
populations in which significant numbers of slaughtered susceptible livestock are not
subject to meat inspection;
iv) all evidence suggestive of CBPP is investigated by field and laboratory methods (including
serological and microbiological assessment) to refute a possible diagnosis of CBPP;
v) there is an effective reporting system, both from the field to the central veterinary
authority, and by that body to the OIE;
vi) there is an effective system to prevent the introduction of infection, including appropriate
border control, quarantine etc.;
vii) if vaccination has been used, all vaccination against CBPP has ceased by the date of
declaration; the OIE and neighbouring countries having been notified in writing, giving the
date from which vaccination was discontinued.
b) Freedom from clinical CBPP
A country which has declared itself or a zone to be provisionally free from disease may be
declared by the OIE free from clinical CBPP, provided that the following criteria are met:
i) no clinical or pathological evidence of CBPP has been detected for at least 5 years;
ii) no CBPP vaccination has taken place for at least 2 years;
iii) the country operates surveillance and disease reporting systems for CBPP adequate to
detect disease if it were present, and ensures that veterinary staff are adequately trained in
the recognition of CBPP;
iv) all susceptible livestock at recognised abattoirs are subject to meat inspection procedures
adequate to detect lung lesions, with diagnostic procedures to refute a possible diagnosis of
CBPP;
v) there has been a programme of surveillance (using serological, pathological and
microbiological techniques) for at least 2 years on any populations of susceptible domestic
livestock where more than 10% of slaughtering is not subject to adequate meat inspection
procedures;
vi) all evidence suggestive of CBPP is investigated by field and laboratory methods (including
serological and microbiological assessment) to refute a possible diagnosis of CBPP;
vii) there are effective measures in force to prevent re-introduction of the disease.
On meeting these criteria, a country may apply to the OIE for all, or a zone, of its territory to
be declared free from clinical CBPP.
An Expert Panel for the Verification of Disease Status of the OIE will evaluate the application
and decide whether or not to approve it. In coming to its decision, the Expert Panel will
consider evidence presented by the country and will gather information on the extent to which
the criteria are met. This information-gathering will usually include sending members of the
Panel to make a field visit to the country. The Expert Panel will report its findings to the OIE
Scientific Commission for Animal Diseases. The Commission will report its conclusions
annually to the International Committee for endorsement.
To maintain this status, a country must continue to meet these requirements until it is declared
free from CBPP, and must report to the OIE an annual summary of developments.
Should there be a localised temporary outbreak of disease due to re-introduction of CBPP to a
country which has met, or is within 2 years of meeting, the requirements for a declaration of
freedom from clinical CBPP, that country should implement a stamping-out policy, which may
be supported by intensive perifocal vaccination, to eradicate the outbreak. In such
circumstances if no vaccination was carried out, it will then require at least one year from the
date of the last case before the country becomes eligible to apply for a declaration of freedom
from clinical CBPP. If vaccination was used, this period is extended to 2 years from the date of
the last case or the last vaccination (whichever occurs later). In making an application under
these special circumstances, it must be shown that the outbreak did not represent endemic
infection, and that the disease has been eradicated by the actions taken.
The declaration of zones to be free from clinical CBPP will not remove the requirement for the
country subsequently to meet the criteria for declaration of freedom from clinical CBPP for the
country as a whole; if it wishes to achieve that status, it will have to meet all of the requirements
specified above before it can apply for a declaration of freedom from clinical CBPP for the
entire country.
c) Freedom from CBPP
A country or a zone of its territory which has within the last 10 years either vaccinated against
CBPP, or found clinical or pathological evidence of CBPP, may be declared by the OIE to be
free from CBPP if the following criteria are met:
i) it has been declared free from clinical CBPP at least 2 years earlier, and continues to meet
the requirements for this status;
ii) there has been effective abattoir surveillance for at least 4 years, covering all susceptible
domestic livestock;
iii) use has been made of diagnostic procedures capable of differentiating Mycoplasma mycoides
from other bovine Mycoplasma infections in the investigation of respiratory disease, and the
findings are consistent with freedom from M. mycoides infection;
iv) there has been a programme of surveillance, including serological, pathological and
microbiological components, for at least 3 years on any populations of susceptible
domestic livestock where more than 10% of slaughter stock are not subject to adequate
meat inspection procedures.
On satisfying these criteria, a country may apply to the OIE to be declared free from CBPP.
An Expert Panel for the Verification of Disease Status of the OIE will evaluate the application
and decide whether or not to approve it. In coming to its decision, the Expert Panel will
consider evidence presented by the country and will gather information on the extent to which
the criteria are met. This information-gathering will usually include sending members of the
Panel to make a field visit to the country.
The Expert Panel will report its findings to the OIE Scientific Commission for Animal
Diseases. The Commission will report its conclusions annually to the International Committee
for endorsement.
In the special case of a country or zone which has been considered to be continuously free from
CBPP for at least 10 years, and meets all of the following requirements:
v) has not vaccinated against CBPP for at least 10 years;
vi) throughout that period found no clinical or pathological evidence of CBPP infection;
vii) had throughout that period, and undertakes to maintain permanently, an adequate disease
surveillance and reporting system, covering all susceptible domestic livestock;
iii) a stamping-out policy is implemented after any CBPP outbreaks. Within the framework of
the declaration, a minimum period of 12 months will be required after the last sick or
in-contact herd has been slaughtered;
iv) an epidemiological investigation, including serological tests, has been carried out to
determine the prevalence of the disease in the country or infected zone. Special attention
should be given to screening animals transported into or out of the infected herds during
the 6 months preceding detection of the outbreak(s);
v) a system of livestock identification and movement control has been set up in the country
or zone for the purposes of CBPP control and surveillance as follows:
- all herds are officially registered and all animals of susceptible species aged over
12 months are individually identified;
- before being moved, other than for immediate slaughter, all animals of susceptible
species are to be clinically inspected and serologically tested for CBPP;
vi) all animals of susceptible species in herds or establishments within a 3-km radius of an
outbreak, and any animals with a possible epidemiological link, are individually identified,
placed in quarantine for at least 6 months, and
- during the quarantine period, animals in the aforementioned herds or establishments are
not to be moved other than to an officially approved abattoir, where they are to be
immediately slaughtered and subjected to sanitary inspection after slaughter;
- microbiological tests should be carried out on animals presenting lesions suggestive of
CBPP;
vii) surveillance is carried out in abattoirs in the contaminated country. Any lesion suggestive
of CBPP should be examined microbiologically and, if the result is positive, the herd of
origin must be found and subjected to serological testing;
viii) the diagnostic tests used in the country or zone comply with OIE standards and are
conducted in a nationally approved laboratory.
b) Freedom from contagious bovine pleuropneumonia
A country or zone may be declared by the OIE to be free from CBPP 2 years after the last
infected and in-contact herds have been slaughtered if the conditions listed in paragraphs a)i) to
a)viii) continue to be met.
4. Epidemiological methods
a) Surveillance systems
In demonstrating that a country or zone is free of disease, it is necessary to conduct a
surveillance programme which would have a very high probability of detecting the disease if it
were present. Surveillance for CBPP will include a combination of clinical, pathological,
serological and microbiological methods, built around an epidemiological surveillance approach.
The mix of procedures used will depend on the specific circumstances of the country or zone.
The most efficient means of detecting CBPP is through effective meat inspection procedures at
abattoirs followed by laboratory examination of suspect lesions. Where a very high proportion
of susceptible domestic livestock are slaughtered in controlled abattoirs, this will provide a very
sensitive surveillance system covering the whole population. It is possible that structured
investigation of a statistical sample of carcasses might be used to augment the routine meat
inspection procedures.
Where large numbers of susceptible livestock are exported for slaughter, it may be necessary to
obtain meat inspection data from the importing country.
Where a significant proportion of susceptible domestic livestock are not subject to meat
inspection at the abattoir, then it will be necessary to use alternative surveillance methods based
on the examination of samples of herds so as to achieve a standard probability of detection.
Animals in sampled herds would be subjected to clinical examination for signs of CBPP, but
not all infected animals exhibit clinical signs. Serological testing can be useful in identifying
infected herds, but due to the limitations of the currently available serological tests, and the
possibility that the disease may be present at very low prevalence, such surveillance systems are
not very efficient in proving freedom from disease, and require large numbers of herds to be
sampled.
b) Definition of sampling units
A sampling unit for the purposes of disease investigation and surveillance is defined as a group
of animals in sufficiently close contact that individuals in the group would be at approximately
equal risk of coming into contact with the disease agent if there were an infectious animal within
the group. In most circumstances, the sampling unit would be a herd which is managed as a unit
by an individual or a community, but there may be other epidemiologically appropriate
groupings which are subject to regular mixing, such as all the animals belonging to residents of a
village. Sampling units should normally be defined so that the majority of units contain between
50 and 1,000 animals.
disease is observed in a livestock population, then the diagnosis of CBPP should be considered
and confirmed or rejected on the basis of further pathological, microbiological or serological
investigations.
f) Gross pathology
The lung lesions of CBPP are distinctive. Consequently, abattoir meat inspection is the most
practical single method for maintaining CBPP surveillance. The pleura and lungs should be
examined by palpation and section. A mixture of acute lesions and chronic lesions (sequestra)
may be found in the same herd or even the same animal. In case of chronic infection,
post-mortem diagnosis may be the only way of detecting asymptomatic animals, which may not
react to serological tests.
g) Serological diagnosis
The serological test of choice is the complement fixation test (CFT). The specificity of this test
can be as high as 99.5%, but the frequency of false positive reactions may temporarily be higher
in certain herds. The sensitivity of the test is limited, and it may fail to identify four classes of
animals:
i) animals in the very early stages of the disease;
ii) animals in the very late stages of the disease (the CFT appears to fail to detect 30% of
animals containing sequestra);
iii) animals with massive lesions, where the antibodies produced are overwhelmed by the
antigen;
iv) animals which have been treated in the early stages of the disease may fail to develop a
detectable serological response.
Despite these limitations, the CFT is a useful herd test.
The CFT reaction after vaccination is inconstant and short-lived (generally less than 3 months).
An indirect enzyme linked immunosorbent assay (ELISA) is under field evaluation in several
countries. It is at least as sensitive as the CFT, but as with other ELISA systems, increased
sensitivity can only be achieved at the expense of specificity, and vice versa. It is a useful tool to
measure the efficacy of vaccination programmes, as the detectable response is more reliable
than the CFT, and may persist for as long as one year after vaccination.
Monoclonal and competitive ELISA systems are being developed and should offer higher
specificity.
The passive haemagglutination test, while not used routinely, may have a place in serological
diagnosis. It is more sensitive than the CFT in early and late stages of disease, but the specificity
is lower. It has a potential role as a screening test.
The slide agglutination test is simple to perform and could be used as a pen-side test. It is more
sensitive than the CFT in the early stages of the disease, but it lacks specificity.
h) Culture and identification of the causative organism
It is desirable that all diagnoses are confirmed by isolation of the causative organism. It may
prove difficult to isolate Mycoplasma from chronic lesions and also after animals have been
treated with anti-microbial drugs.
The causative organism is normally identified by growth inhibition tests and/or the
immunofluorescence test. Closely related Mycoplasma may cause cross-reactions in these tests.
Several new techniques which may overcome this problem are being developed, and these
include immunobinding, immunoperoxidase and polymerase chain reaction (PCR) tests. These
need further evaluation.
Article 3.8.4.1.
Introduction
1. Depending on the risk category of a country, zone or compartment with regard to bovine spongiform
encephalopathy (BSE), surveillance for BSE may have one or more goals:
a) detecting BSE, to a pre-determined design prevalence, in a country, zone or compartment;
b) monitoring the evolution of BSE in a country, zone or compartment;
c) monitoring the effectiveness of a feed ban and/or other risk mitigation measures, in
conjunction with auditing;
d) supporting a claimed BSE status;
e) gaining or regaining a higher BSE status.
2. When the BSE agent is present in a country or zone, the cattle population will comprise the following
sectors, in order of decreasing size:
a) cattle not exposed to the infective agent;
b) cattle exposed but not infected;
c) infected cattle, which may lie within one of three stages in the progress of BSE:
i) the majority will die or be killed before reaching a stage at which BSE is detectable by
current methods;
ii) some will progress to a stage at which BSE is detectable by testing before clinical signs
appear;
iii) the smallest number will show clinical signs.
3. The BSE status of a country, zone or compartment cannot be determined only on the basis of a
surveillance programme but should be determined in accordance with all the factors listed in
Article 2.3.13.2. The surveillance programme should take into account the diagnostic limitations
associated with the above sectors and the relative distributions of infected cattle among them.
4. With respect to the distribution and expression of the BSE agent within the sectors described above,
the following four subpopulations of cattle have been identified for surveillance purposes:
a) cattle over 30 months of age displaying behavioural or clinical signs consistent with BSE;
b) cattle over 30 months of age that are non-ambulatory, recumbent, unable to rise or to walk
without assistance; cattle over 30 months of age sent for emergency slaughter or condemned at
ante-mortem inspection (casualty, emergency slaughter or downer cattle);
c) cattle over 30 months of age which are found dead on farm, during transport or at an abattoir
(fallen stock);
d) cattle over 36 months of age at routine slaughter.
5. A gradient is used to describe the relative value of surveillance applied to each subpopulation.
Surveillance should focus on the first subpopulation, but investigation of other subpopulations will
help to provide an accurate assessment of the BSE situation in the country, zone or compartment. All
countries should sample at least three of the four subpopulations. This approach is consistent with
Appendix 3.8.1. on general guidelines for animal health surveillance.
Article 3.8.4.2.
1. Cattle over 30 months of age displaying behavioural or clinical signs consistent with BSE
Cattle affected by illnesses that are refractory to treatment, and displaying progressive behavioural
changes such as excitability, persistent kicking when milked, changes in herd hierarchical status,
hesitation at doors, gates and barriers, as well as those displaying progressive neurological signs
without signs of infectious illness are candidates for examination. These behavioural changes, being
very subtle, are best identified by those who handle animals on a daily basis. Since BSE causes no
pathognomonic clinical signs, all countries with cattle populations will observe individual animals
displaying clinical signs consistent with BSE. It should be recognised that cases may display only
some of these signs, which may also vary in severity, and such animals should still be investigated as
potential BSE affected animals. The rate at which such suspicious cases are likely to occur will differ
among epidemiological situations and cannot therefore be predicted reliably.
This subpopulation, particularly cattle over 30 months of age, is the one exhibiting the highest
prevalence. The recognition greatly depends on the owner’s awareness and observation of suspect
animals. The reporting of these suspect animals when at the farm will depend on the owner’s
motivation based on cost and socio-economic repercussions.
2. Cattle over 30 months of age that are non-ambulatory, recumbent, unable to rise or to walk without
assistance; cattle over 30 months of age sent for emergency slaughter or condemned at ante-mortem
inspection (casualty or emergency slaughter, or downer cattle)
These cattle may have exhibited some of the clinical signs listed above which were not recognised as
being consistent with BSE. Experience in countries where BSE has been identified indicates that this
subpopulation is the one demonstrating the second highest prevalence. For that reason, it is the
second most appropriate population to target in order to detect BSE.
3. Cattle over 30 months of age which are found dead on farm, during transport or at an abattoir (fallen
stock)
These cattle may have exhibited some of the clinical signs listed above prior to death, but were not
recognised as being consistent with BSE. Experience in countries where BSE has been identified
indicates that this subpopulation is the one demonstrating the third highest prevalence.
4. Cattle over 36 months of age at routine slaughter
Experience in countries where BSE has been identified indicates that this subpopulation is the one
demonstrating the lowest prevalence. For that reason, it is the least appropriate population to target
in order to detect BSE. However, sampling in this subpopulation may be an aide in monitoring the
progress of the epizootic and the efficacy of control measures applied, because it offers continuous
access to a cattle population of known class, age structure and geographical origin. Testing of routine
slaughter cattle 36 months of age or less is of relatively very little value (Table 2).
Within each of the above subpopulations, countries may wish to target cattle identifiable as imported
from countries or zones not free from BSE, cattle which have consumed potentially contaminated
feedstuffs from countries or zones not free from BSE, offspring of BSE affected cows and cattle
which have consumed feedstuffs potentially contaminated with other TSE agents.
When establishing a surveillance strategy, authorities must take into account inherent difficulties of
obtaining samples on farm. These difficulties include higher cost, necessity for education and
motivation of owners, counteracting potentially negative socio-economic implication. Authorities
must find ways to overcome these difficulties.
Article 3.8.4.3.
In order to implement efficiently a maintenance surveillance strategy for BSE, a country must use
good quality data (or reliable estimates) concerning the age distribution of its adult cattle population
and the number of cattle tested for BSE stratified by age and by subpopulation. The application of
the following procedure will allow the detection of BSE prevalence of at least one case per 50,000 in
the adult cattle population, at a confidence level of 95% in the country, zone or compartment of
concern. This Appendix utilises Tables 1 and 2 to determine a desired surveillance point target and
the point values of surveillance samples collected.
Maintenance surveillance should focus on the higher prevalence subpopulations (especially clinical
suspects). The number of clinical suspect samples taken annually should approximate the number of
samples taken annually from clinical suspect cases during the time taken to reach the country, zone or
compartment’s BSE status (to a maximum of 7 years).
Article 3.8.4.4.
The total points for samples collected may be accumulated over a period of a maximum of
7 consecutive years to achieve the target number of points determined in Table 1.
Table 2. Surveillance point values for samples
collected from animals in the given subpopulation and age category
Surveillance subpopulation
Routine Fallen Casualty Clinical
Slaughter2 stock3 slaughter4 suspect5
Age >1 year and <2years
0.01 0.2 0.4 N/A
Age >2 years and <4 years (young adult)
0.1 0.2 0.4 260
Age >4 years and <7 years (middle adult)
0.2 0.9 1.6 750
Age >7 years and <9 years (older adult)
0.1 0.4 0.7 220
Age >9 years (aged)
0.0 0.1 0.2 45
Surveillance points remain valid for 7 years (the 95th percentile of the incubation period).
Article 3.8.4.5.
To monitor the evolution of BSE in a country, zone or compartment once it is detected, a more intensive
sampling method needs to be used to determine disease prevalence. For countries that have determined
that BSE exists within their cattle population, the goal of surveillance shifts from one of detection to one
of monitoring the extent and evolution of the disease, and monitoring the effectiveness of control
measures such as feed bans and policies for the removal of specified risk materials.
Article 3.8.5.1.
Introduction
The first step in determining the bovine spongiform encephalopathy (BSE) risk status of the cattle
population of a country or zone is to conduct a risk assessment (reviewed annually), based on Section 1.3. of
this Terrestrial Code, identifying all potential factors for BSE occurrence and their historic perspective.
1. Release assessment
Release assessment consists of assessing the likelihood that a transmissible spongiform
encephalopathy (TSE) agent has been introduced via the importation of the following commodities
potentially contaminated with a TSE agent:
a) meat-and-bone meal or greaves;
b) live animals;
c) animal feed and feed ingredients;
d) products of animal origin for human consumption.
2. Exposure assessment
Exposure assessment consists of assessing the likelihood of exposure of the BSE agent to cattle,
through a consideration of the following:
a) epidemiological situation concerning all animal TSE agents in the country or zone;
b) recycling and amplification of the BSE agent through consumption by cattle of meat-and-bone
meal or greaves of ruminant origin, or other feed or feed ingredients contaminated with these;
c) the origin and use of ruminant carcasses (including fallen stock), by-products and
slaughterhouse waste, the parameters of the rendering processes and the methods of animal
feed manufacture;
d) implementation and enforcement of feed bans, including measures to prevent
cross-contamination of animal feed.
The following guidelines are intended to assist Veterinary Services in conducting such a risk assessment.
Article 3.8.5.2.
The potential for the release of the BSE agent through importation of meat-and-bone meal or
greaves
This point is irrelevant if the exposure assessment outlined below in Article 3.8.5.5. indicates that
meat-and-bone meal or greaves has not been fed, either deliberately or accidentally, in the past 8 years.
Nevertheless, documentation should be provided on the control systems (including relevant legislation) in
place to ensure that meat-and-bone meal or greaves has not been fed to ruminants.
Assumption: That meat-and-bone meal or greaves of ruminant origin plays the only significant role in BSE
transmission.
Question to be answered: Has meat-and-bone meal, greaves, or feedstuffs containing either been imported
within the past 8 years? If so, where from and in what quantities?
Rationale: Knowledge of the origin of meat-and-bone meal, greaves or feedstuffs containing either
meat-and-bone meal or greaves, is necessary to assess the risk of release of BSE agent. Meat-and-bone meal and
greaves originating in countries of high BSE risk pose a higher release risk than that from low risk
countries. Meat-and-bone meal and greaves originating in countries of unknown BSE risk pose an unknown
release risk.
Evidence required:
- Documentation to support claims that meat-and-bone meal, greaves or feedstuffs containing either
meat-and-bone meal or greaves have not been imported, OR
- Where meat-and-bone meal, greaves or feedstuffs containing them have been imported, documentation
of country of origin and, if different, the country of export.
- Documentation on annual volume, by country of origin, of meat, greaves or feedstuffs containing
them imported during the past 8 years.
- Documentation describing the composition (on a species and class of stock basis) of the imported
meat-and-bone meal, greaves or feedstuffs containing them.
- Documentation, from the country of production, supporting why the rendering processes used to
produce meat-and-bone meal, greaves or feedstuffs containing them would have inactivated, or
significantly reduced the titre of TSE agent, should it be present.
- Documentation describing the fate of imported meat-and-bone meal and greaves.
Article 3.8.5.3.
The potential for the release of the BSE agent through the importation of live animals potentially
infected with a TSE
Assumptions:
- Countries which have imported ruminants from countries infected with animal TSEs are more likely
to experience BSE.
- Cattle pose the only known risk although other species are under stud.
- Animals imported for breeding may pose a greater risk than animals imported for slaughter because
of the hypothetical risk of maternal transmission and because they are kept to a greater age than
animals imported for slaughter.
- Risk is influenced by the date at which imports occurred, relative to the BSE status of the country of
origin.
- Risk is proportional to volume of imports (Article 1.3.2.3.).
Question to be answered: Have live animals been imported within the past 7 years?
Rationale: The release risks are dependent on:
- country of origin and its BSE status, which will change as more data become available; this may
result from the detection of clinical disease, or following active surveillance, or assessment of
geographical BSE risk;
- feeding and management of the animals in the country of origin;
- use to which the commodity has been put as apart from representing risk of developing clinical
disease, the slaughter, rendering and recycling in meat-and-bone meal of imported animals represents a
potential route of exposure of indigenous livestock even if meat-and-bone meal and greaves, or
feedstuffs containing them, have not been imported;
- species;
- dairy versus meat breeds, where there are differences in exposure in the country of origin because
feeding practices result in greater exposure of one category;
- age at slaughter.
Evidence required:
- Documentation on the country of origin of imports. This should identify the country of breeding of
animals, the length of time they lived in that country and of any other country in which they have
resided during their lifetime.
- Documentation describing origins, species and volume of imports.
- Documentation describing the fate of imported animals, including their age at slaughter.
- Documentation demonstrating that risks are periodically reviewed in light of evolving knowledge on
the BSE status of the country of origin.
Article 3.8.5.4.
The potential for the release of the BSE agent through the importation of products of animal
origin potentially infected with a TSE
Assumptions:
- Semen, embryos, hides and skins or milk are not considered to play a role in the transmission of
BSE.
- Countries which have imported products of animal origin from countries with animal TSEs are more
likely to experience BSE.
- Risk is influenced by the date at which imports occurred, relative to the animal TSE status of the
country of origin.
- Risk is proportional to volume of imports (Article 1.3.2.3.).
Question to be answered: What products of animal origin have been imported within the past 7 years?
Rationale: The release risks are dependent on:
- the species of origin of the animal products and whether these products contain tissues known to
contain BSE infectivity (Article 2.3.13.13.);
- country of origin and its animal TSE status, which will change as more data become available; this
may result from the detection of clinical disease, or following active surveillance, or assessment of
geographical BSE risk;
- feeding and management of the animals in the country of origin;
- use to which the commodity has been put as apart from representing risk of developing clinical
disease, the slaughter, rendering and recycling in meat-and-bone meal of imported animals represents a
potential route of exposure of indigenous livestock even if meat-and-bone meal and greaves, or
feedstuffs containing them, have not been imported;
- species;
- dairy versus meat breeds, where there are differences in exposure in the country of origin because
feeding practices result in greater exposure of one category;
- age at slaughter.
Evidence required:
- Documentation on the country of origin of imports. This should identify the country of breeding of
animals, the length of time they lived in that country and of any other country in which they have
resided during their lifetime.
- Documentation describing origins, species and volume of imports
- Documentation describing the end use of imported animal products, and the disposal of waste
- Documentation demonstrating that risks are periodically reviewed in light of evolving knowledge on
the BSE status of the country of origin.
Article 3.8.5.5.
The potential for the exposure of cattle to the BSE agent through consumption of
meat-and-bone meal or greaves of ruminant origin
Assumptions:
- That the consumption by bovines of meat-and-bone meal or greaves of ruminant origin plays the only
significant role in BSE transmission.
- That commercially-available products of animal origin used in animal feeds may contain
meat-and-bone meal or greaves of ruminant origin.
- Milk and blood are not considered to play a role in the transmission of BSE.
Question to be answered: Has meat-and-bone meal or greaves of ruminant origin been fed to cattle within the
past 8 years (Articles 2.3.13.3. and 2.3.13.4. in the Terrestrial Code)?
Rationale: If cattle have not been fed products of animal origin (other than milk or blood) potentially
containing meat-and-bone meal or greaves of ruminant origin within the past 8 years, meat-and-bone meal and
greaves can be dismissed as a risk.
Article 3.8.5.6.
Assumptions:
- BSE may have originated from scrapie of sheep. Countries with scrapie may be at greater risk than
those which have demonstrated scrapie freedom.
- Theoretically, scrapie in small ruminants might mask the presence of BSE and no field methods are
available to differentiate between different TSEs.
- Available evidence suggests there is no link between chronic wasting disease of cervids and BSE.
- It has been suggested that transmissible mink encephalopathy may be an indicator of a hitherto
undefined and hypothetical TSE of cattle.
- If a hypothetical ‘spontaneous’ TSE of cattle is assumed to occur, it must also be assumed to occur
in all countries at a similar rate.
Question to be answered: Have other animal TSEs been identified in the country? What surveillance is there
for TSEs?
Rationale: Surveillance programmes generate a picture of the epidemiological situation of animal TSE. The
greater the surveillance effort, the greater the power of the information. Adequately targeted surveillance
for BSE, such as described in Appendix 3.8.4., provides more powerful information than generic animal
disease surveillance.
Evidence required: Documentation on awareness and surveillance programmes targeting all TSEs of
livestock, their legal basis, scale, duration, and data generated.
Article 3.8.5.7.
The origin of animal waste, the parameters of the rendering processes and the methods of
animal feed production
Assumptions:
- TSE of livestock have long incubation periods and insidious onset of signs, so cases may escape
detection.
- Pre-clinical TSE cannot be detected by any method and may enter rendering, in particular if specified
risk materials are not removed.
- Tissues most likely to contain high titres of TSE infectivity (brain, spinal cord, eyes) may not be
harvested for human consumption and may be rendered.
- TSE of livestock may manifest in sudden death, chronic disease, or recumbency, and may be
presented as fallen stock or materials condemned as unfit for human consumption.
- TSE agent survival in rendering is affected by the method of processing. Adequate rendering
processes are described in Appendix 3.6.3.
- TSE agent is present at much higher titres in central nervous system and reticulo-endothelial tissues
(so-called ‘Specified Risk Materials’, or SRM).
Question to be answered: How has animal waste been processed over the past 8 years?
Rationale: If potentially infected animals or contaminated materials are rendered, there is a risk that the
resulting meat-and-bone meal could retain TSE infectivity.
Where meat-and-bone meal is utilized in the production of any animal feeds, the risk of cross-contamination
exists.
Evidence required:
- Documentation describing the collection and disposal of fallen stock and materials condemned as
unfit for human consumption.
- Documentation describing the definition and disposal of specified risk material, if any.
- Documentation describing the rendering process and parameters used to produce meat-and-bone meal
and greaves.
- Documentation describing methods of animal feed production, including details of ingredients used,
the extent of use of meat-and-bone meal in any livestock feed, and measures that prevent
cross-contamination of cattle feed with ingredients used in monogastric feed.
- Documentation describing monitoring and enforcement of the above.
Article 3.8.5.8.
The overall risk of BSE in the cattle population of a country or zone is proportional to the level of known
or potential exposure to BSE infectivity and the potential for recycling and amplification of the infectivity
through livestock feeding practices. For the risk assessment to conclude that the cattle population of a
country or zone is free from BSE risk, it must have demonstrated that appropriate measures have been
taken to manage any risks identified.
Article 3.8.6.1.
Introduction
This Appendix outlines principles for declaring a country or zone free from scrapie.
An essential prerequisite to provide the guarantees required for the recognition of freedom from
disease/infection is that the Veterinary Services of the Member Country comply with the provisions of
Chapter 1.3.3. on evaluation of Veterinary Services, and, if relevant, with the provisions of Chapter 1.3.5.
on zoning and compartmentalisation.
The provisions of this Appendix are based on the principles developed in Appendix 3.8.1. and the
following premises:
1. the sheep population of the country or zone includes a range of genotypes known to be susceptible to
scrapie;
2. the Veterinary Services have the competence, capacity and mandate to investigate, diagnose and report
scrapie, if present;
3. the absence of scrapie over a long period of time can be substantiated by effective disease
investigation and reporting by the Veterinary Services of an OIE Member Country.
Article 3.8.6.2.
1. Historically free
A country or zone may be recognised free from scrapie without having applied the requirements of
Article 2.4.8.3. when:
a) scrapie has been notifiable for at least 25 years, and
b) a formal programme of targeted surveillance and monitoring can be documented as having been
in place for at least 10 years, and
c) the presence of a range of scrapie susceptible genotypes in this sheep population can be
documented, and
d) appropriate measures to prevent scrapie introduction can be documented as having been in
place for at least 25 years, and
i) either scrapie has never been reported; or
ii) no case of scrapie has been reported for at least 25 years.
Article 3.8.7.1.
Introduction
This Appendix defines the principles and provides a guide for the surveillance of foot and mouth disease
(FMD) in accordance with Appendix 3.8.1. applicable to countries seeking recognition from the OIE for
freedom from FMD, either with or without the use of vaccination. This may be for the entire country or a
zone or compartment within the country. Guidance for countries seeking reestablishment of freedom from
FMD for the whole country or a zone or a compartment, either with or without vaccination, following an
outbreak, as well as guidelines for the maintenance of FMD status are provided. These guidelines are
intended to expand on and explain the requirements of Chapter 2.2.10. Applications to the OIE for
recognition of freedom should follow the format and answer all the questions posed by the
“Questionnaire on FMD” available from the OIE Central Bureau.
The impact and epidemiology of FMD differ widely in different regions of the world and therefore it is
impossible to provide specific guidelines for all situations. It is axiomatic that the surveillance strategies
employed for demonstrating freedom from FMD at an acceptable level of confidence will need to be
adapted to the local situation. For example, the approach to proving freedom from FMD following an
outbreak caused by a pig-adapted strain of FMD virus (FMDV) should differ significantly from an
application designed to prove freedom from FMD for a country or zone where African buffaloes
(Syncerus caffer) provide a potential reservoir of infection. It is incumbent upon the applicant country to
submit a dossier to the OIE in support of its application that not only explains the epidemiology of FMD
in the region concerned but also demonstrates how all the risk factors are managed. This should include
provision of scientifically-based supporting data. There is therefore considerable latitude available to
Member Countries to provide a well-reasoned argument to prove that the absence of FMDV infection (in
non-vaccinated populations) or circulation (in vaccinated populations) is assured at an acceptable level of
confidence.
Surveillance for FMD should be in the form of a continuing programme designed to establish that the
whole territory or part of it is free from FMDV infection/circulation.
For the purposes of this Appendix, virus circulation means transmission of FMDV as demonstrated by
clinical signs, serological evidence or virus isolation.
Article 3.8.7.2.
1. A surveillance system in accordance with Appendix 3.8.1. should be under the responsibility of the
Veterinary Administration. A procedure should be in place for the rapid collection and transport of
samples from suspect cases of FMD to a laboratory for FMD diagnoses as described in the
Terrestrial Manual.
2. The FMD surveillance programme should:
a) include an early warning system throughout the production, marketing and processing chain for
reporting suspicious cases. Farmers and workers who have day-to-day contact with livestock, as
well as diagnosticians, should report promptly any suspicion of FMD. They should be
supported directly or indirectly (e.g. through private veterinarians or veterinary para-professionals)
by government information programmes and the Veterinary Administration. All suspect cases of
FMD should be investigated immediately. Where suspicion cannot be resolved by
epidemiological and clinical investigation, samples should be taken and submitted to an approved
laboratory. This requires that sampling kits and other equipment are available for those
responsible for surveillance. Personnel responsible for surveillance should be able to call for
assistance from a team with expertise in FMD diagnosis and control;
b) implement, when relevant, regular and frequent clinical inspection and serological testing of
high-risk groups of animals, such as those adjacent to an FMD infected country or zone (for
example, bordering a game park in which infected wildlife are present).
An effective surveillance system will periodically identify suspicious cases that require follow up and
investigation to confirm or exclude that the cause of the condition is FMDV. The rate at which such
suspicious cases are likely to occur will differ between epidemiological situations and cannot
therefore be predicted reliably. Applications for freedom from FMDV infection/circulation should,
in consequence, provide details of the occurrence of suspicious cases and how they were investigated
and dealt with. This should include the results of laboratory testing and the control measures to
which the animals concerned were subjected during the investigation (quarantine, movement
stand-still orders, etc.).
Article 3.8.7.3.
Surveillance strategies
1. Introduction
The target population for surveillance aimed at identifying disease and infection should cover all the
susceptible species within the country or zone to be recognised as free from FMDV
infection/circulation.
The strategy employed may be based on randomised sampling requiring surveillance consistent with
demonstrating the absence of FMDV infection/circulation at an acceptable level of statistical
confidence. The frequency of sampling should be dependent on the epidemiological situation.
Targeted surveillance (e.g. based on the increased likelihood of infection in particular localities or
species) may be an appropriate strategy. The applicant country should justify the surveillance strategy
chosen as adequate to detect the presence of FMDV infection/circulation in accordance with
Appendix 3.8.1. and the epidemiological situation. It may, for example, be appropriate to target
clinical surveillance at particular species likely to exhibit clear clinical signs (e.g. cattle and pigs). If a
Member Country wishes to apply for recognition of a specific zone or compartment within the country
as being free from FMDV infection/circulation, the design of the survey and the basis for the
sampling process would need to be aimed at the population within the zone or compartment.
For random surveys, the design of the sampling strategy will need to incorporate an
epidemiologically appropriate design prevalence. The sample size selected for testing will need to be
large enough to detect infection/circulation if it were to occur at a predetermined minimum rate.
The sample size and expected disease prevalence determine the level of confidence in the results of
the survey. The applicant country must justify the choice of design prevalence and confidence level
based on the objectives of surveillance and the epidemiological situation, in accordance with
Appendix 3.8.1. Selection of the design prevalence in particular clearly needs to be based on the
prevailing or historical epidemiological situation.
Irrespective of the survey design selected, the sensitivity and specificity of the diagnostic tests
employed are key factors in the design, sample size determination and interpretation of the results
obtained. Ideally, the sensitivity and specificity of the tests used should be validated for the
vaccination/infection history and production class of animals in the target population.
Irrespective of the testing system employed, surveillance design should anticipate the occurrence of
false positive reactions. If the characteristics of the testing system are known, the rate at which these
false positives are likely to occur can be calculated in advance. There needs to be an effective
procedure for following up positives to ultimately determine with a high level of confidence, whether
they are indicative of infection/circulation or not. This should involve both supplementary tests and
follow-up investigation to collect diagnostic material from the original sampling unit as well as herds
which may be epidemiologically linked to it.
The principles involved in surveillance for disease/infection are technically well defined. The design of
surveillance programmes to prove the absence of FMDV infection/circulation needs to be carefully
followed to avoid producing results that are either insufficiently reliable to be accepted by the OIE
or international trading partners, or excessively costly and logistically complicated. The design of any
surveillance programme, therefore, requires inputs from professionals competent and experienced in
this field.
2. Clinical surveillance
Clinical surveillance aims at detecting clinical signs of FMD by close physical examination of
susceptible animals. Whereas significant emphasis is placed on the diagnostic value of mass
serological screening, surveillance based on clinical inspection should not be underrated. It may be
able to provide a high level of confidence of detection of disease if a sufficiently large number of
clinically susceptible animals is examined.
Clinical surveillance and laboratory testing should always be applied in series to clarify the status of
FMD suspects detected by either of these complementary diagnostic approaches. Laboratory testing
may confirm clinical suspicion, while clinical surveillance may contribute to confirmation of positive
serology. Any sampling unit within which suspicious animals are detected should be classified as
infected until contrary evidence is produced.
A number of issues must be considered in clinical surveillance for FMD. The often underestimated
labour intensity and the logistical difficulties involved in conducting clinical examinations should not
be underestimated and should be taken into account.
Identification of clinical cases is fundamental to FMD surveillance. Establishment of the molecular,
antigenic and other biological characteristics of the causative virus, as well as its source, is dependent
upon disclosure of such animals. It is essential that FMDV isolates are sent regularly to the regional
reference laboratory for genetic and antigenic characterization.
3. Virological surveillance
Virological surveillance using tests described in the Terrestrial Manual should be conducted:
a) to monitor at risk populations;
b) to confirm clinically suspect cases;
c) to follow up positive serological results;
d) to test “normal” daily mortality, to ensure early detection of infection in the face of vaccination
or in establishments epidemiologically linked to an outbreak.
4. Serological surveillance
Serological surveillance aims at detecting antibodies against FMDV. Positive FMDV antibody test
results can have four possible causes:
a) natural infection with FMDV;
b) vaccination against FMD;
c) maternal antibodies derived from an immune dam (maternal antibodies in cattle are usually
found only up to 6 months of age but in some individuals and in some species, maternal
antibodies can be detected for considerably longer periods);
d) heterophile (cross) reactions.
It is important that serological tests, where applicable, contain antigens appropriate for detecting
antibodies against viral variants (types, subtypes, lineages, topotypes, etc.) that have recently occurred
in the region concerned. Where the probable identity of FMDVs is unknown or where exotic viruses
are suspected to be present, tests able to detect representatives of all serotypes should be employed
(e.g. tests based on nonstructural viral proteins – see below).
It may be possible to use serum collected for other survey purposes for FMD surveillance. However,
the principles of survey design described in this Appendix and the requirement for a statistically valid
survey for the presence of FMDV should not be compromised.
The discovery of clustering of seropositive reactions should be foreseen. It may reflect any of a series
of events, including but not limited to the demographics of the population sampled, vaccinal
exposure or the presence of field strain infection. As clustering may signal field strain infection, the
investigation of all instances must be incorporated in the survey design. If vaccination cannot be
excluded as the cause of positive serological reactions, diagnostic methods should be employed that
detect the presence of antibodies to nonstructural proteins (NSPs) of FMDVs as described in the
Terrestrial Manual.
The results of random or targeted serological surveys are important in providing reliable evidence
that FMDV infection is not present in a country or zone. It is therefore essential that the survey be
thoroughly documented.
Article 3.8.7.4.
Countries applying for freedom from FMD for the whole country or a zone or a compartment
where vaccination is not practised
In addition to the general conditions described in Chapter 2.2.10., a Member Country applying for
recognition of FMD freedom for the country or a zone or a compartment where vaccination is not practised
should provide evidence for the existence of an effective surveillance programme. The strategy and design
of the surveillance programme will depend on the prevailing epidemiological circumstances and will be
planned and implemented according to general conditions and methods in this Appendix, to demonstrate
absence of FMDV infection, during the preceding 12 months in susceptible populations. This requires the
support of a national or other laboratory able to undertake identification of FMDV infection through
virus/antigen/genome detection and antibody tests described in the Terrestrial Manual.
Article 3.8.7.5.
Countries, zones or compartments applying for freedom from FMD where vaccination is
practised
In addition to the general conditions described in Chapter 2.2.10., a Member Country applying for
recognition of country or zone or compartment freedom from FMD with vaccination should show evidence
of an effective surveillance programme planned and implemented according to general conditions and
methods in this Appendix. Absence of clinical disease in the country, zone or compartment for the past
2 years should be demonstrated. Furthermore, surveillance should demonstrate that FMDV has not been
circulating in any susceptible population during the past 12 months. This will require serological
surveillance incorporating tests able to detect antibodies to NSPs as described in the Terrestrial Manual.
Vaccination to prevent the transmission of FMDV may be part of a disease control programme. The level
of herd immunity required to prevent transmission will depend on the size, composition (e.g. species) and
density of the susceptible population. It is therefore impossible to be prescriptive. However, the aim
should, in general, be to vaccinate at least 80% of the susceptible population. The vaccine must comply
with the Terrestrial Manual. Based on the epidemiology of FMD in the country, zone or compartment, it may
be that a decision is reached to vaccinate only certain species or other subsets of the total susceptible
population. In that case, the rationale should be contained within the dossier accompanying the
application to the OIE for recognition of status.
Article 3.8.7.6.
Countries, zones or compartments re-applying for freedom from FMD where vaccination is
either practised or not practised, following an outbreak
In addition to the general conditions described in Chapter 2.2.10., a country re-applying for country, zone
or compartment freedom from FMD where vaccination is practised or not practised should show evidence
of an active surveillance programme for FMD as well as absence of FMDV infection/circulation. This
will require serological surveillance incorporating, in the case of a country, zone or compartment practising
vaccination, tests able to detect antibodies to NSPs as described in the Terrestrial Manual.
Four strategies are recognised by the OIE in a programme to eradicate FMDV infection following an
outbreak:
2. slaughter of all clinically affected and in-contact susceptible animals and vaccination of at-risk
animals, with subsequent slaughter of vaccinated animals;
3. slaughter of all clinically affected and in-contact susceptible animals and vaccination of at-risk
animals, without subsequent slaughter of vaccinated animals;
The time periods before which an application can be made for re-instatement of freedom from FMD
depends on which of these alternatives is followed. The time periods are prescribed in Article 2.2.10.7.
In all circumstances, a Member Country re-applying for country, zone or compartment freedom from FMD
with vaccination or without vaccination should report the results of an active surveillance programme
implemented according to general conditions and methods in this Appendix.
Article 3.8.7.7.
The recommended serological tests for FMD surveillance are described in the Terrestrial Manual.
Animals infected with FMDV produce antibodies to both the structural proteins (SP) and the
nonstructural proteins (NSP) of the virus. Tests for SP antibodies to include SP-ELISAs and the virus
neutralisation test (VNT). The SP tests are serotype specific and for optimal sensitivity should utilise an
antigen or virus closely related to the field strain against which antibodies are being sought. Tests for NSP
antibodies include NSP I-ELISA 3ABC and the electro-immunotransfer blotting technique (EITB) as
recommended in the Terrestrial Manual or equivalent validated tests. In contrast to SP tests, NSP tests can
detect antibodies to all serotypes of FMD virus. Animals vaccinated and subsequently infected with FMD
virus develop antibodies to NSPs, but in some, the titre may be lower than that found in infected animals
that have not been vaccinated. Both the NSP I-ELISA 3ABC and EITB tests have been extensively used
in cattle. Validation in other species is ongoing. Vaccines used should comply with the standards of the
Terrestrial Manual insofar as purity is concerned to avoid interference with NSP antibody testing.
Serological testing is a suitable tool for FMD surveillance. The choice of a serosurveillance system will
depend on, amongst other things, the vaccination status of the country. A country, which is free from
FMD without vaccination, may choose serosurveillance of high-risk subpopulations (e.g. based on
geographical risk for exposure to FMDV). SP tests may be used in such situations for screening sera for
evidence of FMDV infection/circulation if a particular virus of serious threat has been identified and is
well characterised. In other cases, NSP testing is recommended in order to cover a broader range of
strains and even serotypes. In both cases, serological testing can provide additional support to clinical
surveillance. Regardless of whether SP or NSP tests are used in countries that do not vaccinate, a
diagnostic follow-up protocol should be in place to resolve any presumptive positive serological test
results.
In areas where animals have been vaccinated, SP antibody tests may be used to monitor the serological
response to the vaccination. However, NSP antibody tests should be used to monitor for FMDV
infection/circulation. NSP-ELISAs may be used for screening sera for evidence of infection/circulation
irrespective of the vaccination status of the animal. All herds with seropositive reactors should be
investigated. Epidemiological and supplementary laboratory investigation results should document the
status of FMDV infection/circulation for each positive herd. Tests used for confirmation should be of
high diagnostic specificity to eliminate as many false positive screening test reactors as possible. The
diagnostic sensitivity of the confirmatory test should approach that of the screening test. The EITB or
another OIE-accepted test should be used for confirmation.
Information should be provided on the protocols, reagents, performance characteristics and validation of
all tests used.
1. The follow-up procedure in case of positive test results if no vaccination is used in order to establish
or re-establish FMD free status without vaccination
Any positive test result (regardless of whether SP or NSP tests were used) should be followed up
immediately using appropriate clinical, epidemiological, serological and, where possible, virological
investigations of the reactor animal at hand, of susceptible animals of the same epidemiological unit
and of susceptible animals that have been in contact or otherwise epidemiologically associated with
the reactor animal. If the follow up investigations provide no evidence for FMDV infection, the
reactor animal shall be classified as FMD negative. In all other cases, including the absence of such
follow-up investigations, the reactor animal should be classified as FMD positive.
2. The follow-up procedure in case of positive test results if vaccination is used in order to establish or
re-establish FMD free status with vaccination
In case of vaccinated populations one has to exclude that positive test results are indicative of virus
circulation. To this end the following procedure should be followed in the investigation of positive
serological test results derived from surveillance conducted on FMD vaccinated populations.
The investigation should examine all evidence that might confirm or refute the hypothesis that the
positive results to the serological tests employed in the initial survey were not due to virus
circulation. All the epidemiological information should be substantiated and the results should be
collated in the final report.
It is suggested that in the primary sampling units where at least one animal reacts positive to the NSP
test, the following strategy(ies) should be applied:
a) Following clinical examination, a second serum sample should be taken from the animals tested
in the initial survey after an adequate interval of time has lapsed, on the condition that they are
individually identified, accessible and have not been vaccinated during this period. Antibody
titres against NSP at the time of retest should be statistically either equal to or lower than those
observed in the initial test if virus is not circulating.
The animals sampled should remain in the holding pending test results and should be clearly
identifiable. If the three conditions for retesting mentioned above cannot be met, a new
serological survey should be carried out in the holding after an adequate period of time,
repeating the application of the primary survey design and ensuring that all animals tested are
individually identified. These animals should remain in the holding and should not be
vaccinated, so that they can be retested after an adequate period of time.
b) Following clinical examination, serum samples should be collected from representative numbers
of cattle that were in physical contact with the primary sampling unit. The magnitude and
prevalence of antibody reactivity observed should not differ in a statistically significant manner
from that of the primary sample if virus is not circulating.
c) Following clinical examination, epidemiologically linked herds should be serologically tested and
satisfactory results should be achieved if virus is not circulating.
d) Sentinel animals can also be used. These can be young, unvaccinated animals or animals in
which maternally conferred immunity has lapsed and belonging to the same species resident
within the positive initial sampling units. They should be serologically negative if virus is not
circulating. If other susceptible, unvaccinated ruminants (sheep, goats) are present, they could
act as sentinels to provide additional serological evidence.
Laboratory results should be examined in the context of the epidemiological situation. Corollary
information needed to complement the serological survey and assess the possibility of viral circulation
includes but is not limited to:
The entire investigative process should be documented as standard operating procedure within the
surveillance programme.
Key:
ELISA Enzyme-linked immunosorbent assay
VNT Virus neutralisation test
NSP Nonstructural protein(s) of foot and mouth disease virus (FMDV)
3ABC NSP antibody test
EITB Electro-immuno transfer blotting technique (Western blot for NSP antibodies of FMDV)
OP Oesophageal-pharyngeal sample
SP Structural protein test
S No evidence of FMDV
Article 3.8.8.1.
Introduction
This Appendix defines the principles and provides a guide for the surveillance of classical swine fever
(CSF) in accordance with Appendix 3.8.1., applicable to countries seeking recognition of freedom from
CSF. This may be for the entire country or a zone within the country. Guidance for countries seeking
reestablishment of freedom from CSF for the whole country or a zone, following an outbreak, as well as
guidelines for demonstrating the maintenance of CSF free status are also provided. This Appendix
complements Chapter 2.6.7.
The impact and epidemiology of CSF differ widely in different regions of the world, and it is, therefore,
impossible to provide specific guidelines for all situations. It is axiomatic that the surveillance strategies
employed for demonstrating freedom from CSF at an acceptable level of confidence will need to be
adapted to the local situation. For example, the approach must be tailored in order to prove freedom
from CSF for a country or zone where wild pigs provide a potential reservoir of infection, or where CSF is
present in adjacent countries. The method must examine the epidemiology of CSF in the region
concerned and adapt to the specific risk factors encountered. This should include provision of
scientifically based supporting data. There is, therefore, latitude available to Member Countries to provide
a well-reasoned argument to prove that absence of classical swine fever virus (CSFV) infection is assured
at an acceptable level of confidence.
Surveillance for CSF should be in the form of a continuing programme designed to establish that the
whole country or zone is free from CSFV infection. Consideration should be given to the specific
characteristics of CSF epidemiology which include: the role of swill feeding and the impact of different
production systems on disease spread, the role of semen in transmission of the virus, the lack of
pathognomonic gross lesions and clinical signs, the frequency of clinically inapparent infections, the
occurrence of persistent and chronic infections, and the genotypic, antigenic, and virulence variability
exhibited by different strains of CSFV. Serological cross-reactivity with other pestiviruses has to be taken
into consideration when interpreting data from serological surveys. A common route by which ruminant
pestiviruses can infect pigs is the use of vaccines contaminated with bovine viral diarrhoea virus (BVDV).
For the purposes of this Appendix, virus infection means presence of CSFV as demonstrated directly by
virus isolation, the detection of virus antigen or virus nucleic acid, or indirectly by seroconversion which is
not the result of vaccination.
Article 3.8.8.2.
1. A surveillance system in accordance with Appendix 3.8.1. should be under the responsibility of the
Veterinary Administration. A procedure should be in place for the rapid collection and transport of
samples to an accredited laboratory as described in the Terrestrial Manual.
2. The CSF surveillance programme should:
a) include an early warning system throughout the production, marketing and processing chain for
reporting suspicious cases. Farmers and workers, who have day-to-day contact with livestock, as
well as diagnosticians, should report promptly any suspicion of CSF to the Veterinary Authority.
They should be supported directly or indirectly (e.g. through private veterinarians or veterinary
para-professionals) by government information programmes and the Veterinary Administration.
Since many strains of CSFV do not induce pathognomonic gross lesions or clinical signs, cases
in which CSF cannot be ruled out should be immediately investigated employing clinical,
pathological, and laboratory diagnosis. This requires that sampling kits and other equipment are
available to those responsible for surveillance. Personnel responsible for surveillance should be
able to call for assistance from a team with expertise in CSF diagnosis, epidemiological
evaluation, and control;
b) implement, when relevant, regular and frequent clinical inspections and serological testing of
high-risk groups of animals (for example, where swill feeding is practised), or those adjacent to
a CSF infected country or zone (for example, bordering areas where infected wild pigs are
present).
An effective surveillance system will periodically identify suspicious cases that require follow-up and
investigation to confirm or exclude that the cause of the condition is CSFV. The rate at which such
suspicious cases are likely to occur will differ between epidemiological situations and cannot,
therefore, be reliably predicted. Recognitions for freedom from CSFV infection should, as a
consequence, provide details of the occurrence of suspicious cases and how they were investigated
and dealt with. This should include the results of laboratory testing and the control measures to
which the animals concerned were subjected during the investigation (quarantine, movement
stand-still orders, etc.).
Article 3.8.8.3.
Surveillance strategies
1. Introduction
The target population for surveillance aimed at identifying disease and infection should include
domestic and wild pig populations within the country or zone to be recognised as free from CSFV
infection. Such surveillance may involve opportunistic testing of samples submitted for other
purposes, but a more efficient and effective strategy is one which includes targeted surveillance.
Depending on the local epidemiological situation, targeted surveillance could be considered as more
effective than a randomized surveillance strategy. Surveillance is targeted to the pig population which
presents the highest risk of infection (for example, swill fed farms, pigs reared outdoors or farms in
proximity to infected wild pigs). Each country will need to identify its individual risk factors. These
may include: temporal and spatial distribution of past outbreaks, pig movements and demographics,
etc.
For reasons of cost, the longevity of antibody levels, as well as the existence of clinically inapparent
infections and difficulties associated with differential diagnosis of other diseases, serology is often
the most effective and efficient surveillance methodology. In some circumstances, which will be
discussed later, clinical and virological surveillance may also have value.
The country should justify the surveillance strategy chosen as adequate to detect the presence of
CSFV infection in accordance with Appendix 3.8.1. and the epidemiological situation. Cumulative
survey results in combination with the results of passive surveillance, over time, will increase the level
of confidence in the surveillance strategy. If a Member Country wishes to apply for recognition by
other Member Countries of a specific zone within the country as being free from CSFV infection, the
design of the surveillance strategy and the basis for any sampling process would need to be aimed at
the population within the zone.
For random surveys, the design of the sampling strategy will need to incorporate epidemiologically
appropriate design prevalence. The sample size selected for testing will need to be large enough to
detect infection if it were to occur at a predetermined minimum rate. The sample size and expected
disease prevalence determine the level of confidence in the results of the survey. The country must
justify the choice of design prevalence and confidence level based on the objectives of surveillance
and the epidemiological situation, in accordance with Appendix 3.8.1. Selection of the design
prevalence in particular clearly needs to be based on the prevailing or historical epidemiological
situation.
Irrespective of the survey design selected, the sensitivity and specificity of the diagnostic tests
employed are key factors in the design, sample size determination and interpretation of the results
obtained. Ideally, the sensitivity and specificity of the tests used should be validated for the
vaccination/infection history and production class of animals in the target population.
Irrespective of the testing system employed, the surveillance system design should anticipate the
occurrence of false positive reactions. This is especially true of the serological diagnosis of CSF
because of the recognized cross-reactivity with ruminant pestiviruses. There needs to be an effective
procedure for following up positives to ultimately determine with a high level of confidence, whether
or not they are indicative of CSFV infection. This should involve confirmatory and differential tests
for pestiviruses, as well as further investigations concerning the original sampling unit as well as
animals which may be epidemiologically linked.
2. Clinical and virological surveillance
Beyond their role in targeted surveillance, clinical and virological surveillance for CSF has two aims:
a) to shorten the period between introduction of CSF virus into a disease free country or zone and its
detection, and b) to confirm that no unnoticed outbreaks have occurred.
One element of clinical surveillance involves the detection of clinical signs of CSF by close physical
examination of susceptible animals. The spectrum of disease signs and gross pathology seen in CSF
infections, along with the plethora of other agents that can mimic CSF, renders the value of clinical
examination alone somewhat inefficient as a surveillance tool. Nevertheless, clinical presentation
should not be ignored as a tool for early detection; in particular, any cases where clinical signs or
lesions consistent with CSF are accompanied by high morbidity and/or mortality should be
investigated without delay. In CSFV infections involving low virulence strains, high mortality may
only be seen in young animals.
In the past, clinical identification of cases was the cornerstone of early detection of CSF. However,
emergence of low virulence strains of CSF, as well as new diseases - in particular post-weaning
multisystemic wasting syndrome and porcine dermatitis and nephropathy syndrome have made such
reliance less effective, and, in countries where such diseases are common, can add significant risk of
masking the presence of CSF. In zones or countries where such diseases exist, careful clinical and
virological surveillance of such cases should be applied.
Clinical signs and pathology of CSF infection will also vary considerably, depending on the strain of
virus as well as host factors, such as age, nutrition and health status. These factors, along with the
compounding effects of concurrent infections and disease caused by ruminant pestiviruses, dictate
the need for laboratory testing in order to clarify the status of CSF suspects detected by clinical
monitoring. The difficulties in detecting chronic disease manifested by non-specific clinical signs and
delayed seroconversion and seronegativity, in persistently infected piglets, both of which may be
clinically normal, makes virological investigation essential. As part of a herd investigation, such
animals are likely to be in a minority and would not confound a diagnosis based on serology.
Individually or as part of recently mixed batches, such animals may, however, escape detection by
this method. A holistic approach to investigation, taking note of herd history, pig, personnel and
vehicle movements and disease status in neighbouring zones or countries, can also assist in targeting
surveillance in order to increase efficiency and enhance the likelihood of early detection.
The labour-intensive nature of clinical, pathological and virological investigations, along with the
smaller ‘window of opportunity’ inherent in virus, rather than antibody detection, has, in the past,
resulted in greater emphasis being placed on mass serological screening as the best method for
surveillance. However, surveillance based on clinical and pathological inspection and virological
testing should not be underrated. If targeted at high risk groups in particular, it provides an
opportunity for early detection that can considerably reduce the subsequent spread of disease. Herds
predominated by adult animals, such as nucleus herds and artificial insemination studs, are
particularly useful groups to monitor, since infection by low virulence viruses in such groups may be
clinically inapparent, yet the degree of spread may be high.
Clinical and virological monitoring may also provide a high level of confidence of rapid detection of
disease if a sufficiently large number of clinically susceptible animals is examined. In particular,
molecular detection methods are increasingly able to offer the possibility of such large-scale
screening for the presence of virus, at reasonable cost.
Wild pigs and, in particular, those with a wholly free-living existence, rarely present the opportunity
for clinical observation, but should form part of any surveillance scheme and should, ideally, be
monitored for virus as well as antibody.
Vaccine design and diagnostic methodologies, and in particular methods of virus detection, are
increasingly reliant on up-to-date knowledge of the molecular, antigenic and other biological
characteristics of viruses currently circulating and causing disease. Furthermore, epidemiological
understanding of the pathways of spread of CSFV can be greatly enhanced by molecular analyses of
viruses in endemic areas and those involved in outbreaks in disease free areas. It is therefore essential
that CSFV isolates are sent regularly to the regional OIE Reference Laboratory for genetic and
antigenic characterisation.
3. Serological surveillance
Serological surveillance aims at detecting antibodies against CSFV. Positive CSFV antibody test
results can have five possible causes:
a) natural infection with CSFV;
b) legal or illegal vaccination against CSF;
c) maternal antibodies derived from an immune sow (maternal antibodies) are usually found only
up to 4.5 months of age, but, in some individuals, maternal antibodies can be detected for
considerably longer periods;
d) cross-reactions with other pestiviruses;
e) non-specific reactors.
The infection of pigs with other pestiviruses may complicate a surveillance strategy based on
serology. Antibodies to bovine viral diarrhoea virus (BVDV) and Border disease virus (BDV) can
give positive results in serological tests for CSF, due to common antigens. Such samples will require
differential tests to confirm their identity. Although persistently infected immunotolerant pigs are
themselves seronegative, they continuously shed virus, so the prevalence of antibodies at the herd
level will be high. Chronically infected pigs may have undetectable or fluctuating antibody levels.
It may be possible to use sera collected for other survey purposes for CSF surveillance. However, the
principles of survey design described in this Appendix and the requirement for statistical validity
should not be compromised.
The discovery of clustering of seropositive reactions should be foreseen. It may reflect any of a series
of events, including but not limited to the demographics of the population sampled, vaccinal
exposure or the presence of infection by field strains or other pestiviruses. Because clustering may
signal field strain infection, the investigation of all instances must be incorporated in the survey
design. Clustering of positive animals is always epidemiologically significant and therefore should be
investigated.
In countries or zones that are moving towards freedom, serosurveillance can provide valuable
information on the disease status and efficacy of any control programme. Targeted serosurveillance
of young stock will indicate whether newly circulating virus is present, although the presence of
maternal antibody will also need to be considered. If conventional attenuated vaccine is currently
being used or has been used in the recent past, serology aimed at detecting the presence of field virus
will likewise need to be targeted at unvaccinated animals and after the disappearance of maternal
antibody. General usage in such situations may also be used to assess levels of vaccine coverage.
Vaccines also exist which, when used in conjunction with dedicated serological tests, may allow
discrimination between vaccinal antibody and that induced by field infection. Such tools, described in
the Terrestrial Manual, will need to be fully validated. They do not confer the same degree of
protection as that provided by conventional vaccines, particularly with respect to preventing
transplacental infections. Furthermore, serosurveillance using such differentiation requires cautious
interpretation on a herd basis.
The results of random or targeted serological surveys are important in providing reliable evidence
that no CSFV infection is present in a country or zone. It is therefore essential that the survey be
thoroughly documented.
Article 3.8.8.4.
Article 3.8.8.5.
Countries, zones or compartments applying for freedom from FMD where vaccination is
practised
1. In addition to the general conditions described in Chapter 2.6.7., a Member Country seeking
recognition of CSF freedom for the country or a zone, whether or not vaccination had been
practised, should provide evidence for the existence of an effective surveillance programme. The
strategy and design of the surveillance programme will depend on the prevailing epidemiological
circumstances and will be planned and implemented according to the general conditions and
methods described in this Appendix, to demonstrate the absence of CSFV infection in domestic and
wild pig populations. This requires the support of a national or other laboratory able to undertake
identification of CSFV infection through virus detection and serological tests described in the
Terrestrial Manual.
2. The objective of surveillance in this instance is to demonstrate that the two subpopulations are
effectively separated by measures that ensure the biosecurity of domestic pigs. To this end, a
biosecurity programme which includes but is not limited to the following provisions should be
implemented:
a) a programme for the management of CSF in wild pigs;
b) delineation of CSF wild pig control areas around every CSF case reported in wild pigs;
c) assessment of the presence and mitigative role of natural boundaries;
d) documentation of the ecology of the wild pig population;
e) proper containment of domestic pigs;
f) control of movement of vehicles with cleaning and disinfection as appropriate;
g) control of personnel entering into the establishments and awareness of risk of fomite spread;
h) prohibition of introduction to the establishments of hunted animals and products;
i) registry of animal movements into and out of establishments;
j) information and training programmes for farmers, hunters, processors, veterinarians, etc.
3. The biosecurity programme implemented would also require internal and external monitoring by the
Veterinary Authorities. These elements should include but are not limited to:
a) periodic clinical and serological monitoring of herds in the country or zone, and adjacent wild
pig populations following these guidelines;
b) herd registration;
c) official accreditation of biosecurity programme;
d) periodic monitoring and review.
4. Monitoring the CSF status of wild populations will be of value in assessing the degree of risk they
pose to the CSF free domestic population. The design of a monitoring system for wild pigs is
dependent on several factors such as the organisation of the Veterinary Services and resources
available. The occurrence of CSF in wild pigs may vary considerably among countries. Surveillance
design should be scientifically based and the Member Country must justify its choice of design
prevalence and level of confidence based on Appendix 3.8.1.
5. The geographic distribution and approximate size of wild pig populations need to be assessed as a
prerequisite for designing a monitoring system. Sources of information may include wildlife
conservation organisations, hunter associations and other available sources. The objective of a
surveillance programme when the disease is already known to exist should be to determine the
geographic distribution and the extent of the infection.
Article 3.8.8.6.
c) animals used to re-populate affected establishments and any establishments where contiguous
culling is carried out;
d) wild pig populations in the area of the outbreak.
In all circumstances, a Member Country seeking reestablishment of country or zone freedom from
CSF with vaccination or without vaccination should report the results of an active and passive
surveillance programme in which the pig population undergoes regular clinical, pathological,
virological, and/or serological examination, planned and implemented according to the general
conditions and methods described in these guidelines. The surveillance should be based on a
statistically representative sample of the populations at risk.
2. Country or zone free of CSF in wild pigs
While the same principles apply, surveillance in wild pigs presents challenges beyond those
encountered in domestic populations in each of the following areas:
a) determination of the distribution, size and movement patterns associated with the wild pig
population;
b) assessment of the possible presence of CSF within the population;
c) determination of the practicability of establishing zone.
The design of a monitoring system for wild pigs is dependent on several factors such as the
organisation of the Veterinary Services and resources available. The geographic distribution and
approximate size of wild pig populations need to be assessed as a prerequisite for designing a
monitoring system. Sources of information may include wildlife conservation organisations, hunter
associations and other available sources. The objective of a surveillance programme is to determine
the geographic distribution and estimation of target population.
Estimates of wild pig population can be made using advanced methods (radio tracking, linear
transect method, capture/recapture) or traditional methods based on the number of animals that can
be hunted to allow for natural restocking (hunting bags).
For implementation of the monitoring programme, it will be necessary to define the limits of the
territory over which wild pigs range in order to delineate the epidemiological units within the
monitoring programme. It is often difficult to define epidemiological units for wild animals. The
most practical approach is based on natural and artificial barriers.
The monitoring programme should also include animals found dead, road kills, animals showing
abnormal behaviour or exhibiting gross lesions during dressing.
There may be situations where a more targeted surveillance programme can provide additional
assurance. The criteria to define high risk areas for targeted surveillance can be:
- areas with past history of CSF;
- sub-regions with high wild pig density;
- border regions with CSF affected countries or zones;
- areas of contact between sub-populations;
- picnic and camping areas;
- around farms with free-ranging pigs;
- special risk areas determined by local Veterinary Authorities;
- garbage dumps.
Article 3.8.9.1.
Introduction
This Appendix defines the principles and provides a guide for the surveillance of notifiable avian
influenza (NAI) in accordance with Appendix 3.8.1., applicable to countries seeking recognition for a
declared NAI status, with or without the use of vaccination. This may be for the entire country, zone or
compartment. Guidance for countries seeking free status following an outbreak and for the maintenance of
NAI status are provided. This Appendix complements Chapter 2.7.12.
The presence of avian influenza viruses in wild birds creates a particular problem. In essence, no country
can declare itself free from avian influenza (AI) in wild birds. However, the definition of NAI in
Chapter 2.7.12. refers to the infection in poultry only and this Appendix was developed under this
definition.
The impact and epidemiology of NAI differ widely in different regions of the world and therefore it is
impossible to provide specific guidelines for all situations. It is axiomatic that the surveillance strategies
employed for demonstrating freedom from NAI at an acceptable level of confidence will need to be
adapted to the local situation. Variables such as the frequency of contacts of poultry with wild birds,
different biosecurity levels and production systems and the commingling of different susceptible species
including domestic waterfowl require specific surveillance strategies to address each specific situation. It is
incumbent upon the country to provide scientific data that explains the epidemiology of NAI in the
region concerned and also demonstrates how all the risk factors are managed. There is therefore
considerable latitude available to Member Countries to provide a well-reasoned argument to prove that
absence of NAI virus (NAIV) infection is assured at an acceptable level of confidence.
Surveillance for NAI should be in the form of a continuing programme designed to establish that the
country, zone or compartment, for which application is made, is free from NAIV infection.
Article 3.8.9.2.
1. A surveillance system in accordance with Appendix 3.8.1. should be under the responsibility of the
Veterinary Administration. In particular:
a) a formal and ongoing system for detecting and investigating outbreaks of disease or NAI infection
should be in place;
b) a procedure should be in place for the rapid collection and transport of samples from suspect
cases of NAI to a laboratory for NAI diagnosis as described in the Terrestrial Manual;
c) a system for recording, managing and analysing diagnostic and surveillance data should be in
place.
2. The NAI surveillance programme should:
a) include an early warning system throughout the production, marketing and processing chain for
reporting suspicious cases. Farmers and workers, who have day-to-day contact with poultry, as
well as diagnosticians, should report promptly any suspicion of NAI to the Veterinary Authority.
They should be supported directly or indirectly (e.g. through private veterinarians or veterinary
para-professionals) by government information programmes and the Veterinary Administration. All
suspected cases of NAI should be investigated immediately. Where suspicion cannot be
resolved by epidemiological and clinical investigation, as is frequently the case with low
pathogenicity notifiable avian influenza (LPNAI) virus infections, samples should be taken and
submitted to an approved laboratory. This requires that sampling kits and other equipment are
available for those responsible for surveillance. Personnel responsible for surveillance should be
able to call for assistance from a team with expertise in NAI diagnosis and control. In cases
where potential public health implications are suspected, notification to the appropriate public
health authorities is essential;
b) implement, when relevant, regular and frequent clinical inspection, serological and virological
testing of high-risk groups of animals, such as those adjacent to an NAI infected country, zone
or compartment, places where birds and poultry of different origins are mixed, such as live bird
markets, poultry in close proximity to waterfowl or other sources of NAIV.
An effective surveillance system will periodically identify suspicious cases that require follow up and
investigation to confirm or exclude that the cause of the condition is NAIV. The rate at which such
suspicious cases are likely to occur will differ between epidemiological situations and cannot therefore be
predicted reliably. Applications for freedom from NAIV infection should, in consequence, provide details
of the occurrence of suspicious cases and how they were investigated and dealt with. This should include
the results of laboratory testing and the control measures to which the animals concerned were subjected
during the investigation (quarantine, movement stand-still orders, etc.).
Article 3.8.9.3.
Surveillance strategies
1. Introduction
The target population for surveillance aimed at identification of disease and infection should cover all
the susceptible poultry species within the country, zone or compartment. Active and passive
surveillance for NAI should be ongoing. The frequency of active surveillance should be at least every
6 months. Surveillance should be composed of random and targeted approaches using virological,
serological and clinical methods.
The strategy employed may be based on randomised sampling requiring surveillance consistent with
demonstrating the absence of NAIV infection at an acceptable level of confidence. The frequency of
sampling should be dependent on the epidemiological situation. Random surveillance is conducted
using serological tests described in the Terrestrial Manual. Positive serological results should be
followed up with virological methods.
Targeted surveillance (e.g. based on the increased likelihood of infection in particular localities or
species) may be an appropriate strategy. Virological and serological methods should be used
concurrently to define the NAI status of high risk populations.
A country should justify the surveillance strategy chosen as adequate to detect the presence of NAIV
infection in accordance with Appendix 3.8.1. and the prevailing epidemiological situation. It may, for
example, be appropriate to target clinical surveillance at particular species likely to exhibit clear
clinical signs (e.g. chickens). Similarly, virological and serological testing could be targeted to species
that may not show clinical signs (e.g. ducks).
If a Member Country wishes to declare freedom from NAIV infection in a specific zone or
compartment, the design of the survey and the basis for the sampling process would need to be aimed
at the population within the zone or compartment.
For random surveys, the design of the sampling strategy will need to incorporate epidemiologically
appropriate design prevalence. The sample size selected for testing will need to be large enough to
detect infection if it were to occur at a predetermined minimum rate. The sample size and expected
disease prevalence determine the level of confidence in the results of the survey. The applicant
country must justify the choice of design prevalence and confidence level based on the objectives of
surveillance and the epidemiological situation, in accordance with Appendix 3.8.1. Selection of the
design prevalence in particular clearly needs to be based on the prevailing or historical
epidemiological situation.
Irrespective of the survey approach selected, the sensitivity and specificity of the diagnostic tests
employed are key factors in the design, sample size determination and interpretation of the results
obtained. Ideally, the sensitivity and specificity of the tests used should be validated for the
vaccination/infection history and the different species in the target population.
Irrespective of the testing system employed, surveillance system design should anticipate the
occurrence of false positive reactions. If the characteristics of the testing system are known, the rate
at which these false positives are likely to occur can be calculated in advance. There needs to be an
effective procedure for following up positives to ultimately determine with a high level of
confidence, whether they are indicative of infection or not. This should involve both supplementary
tests and follow-up investigation to collect diagnostic material from the original sampling unit as well
as flocks which may be epidemiologically linked to it.
The principles involved in surveillance for disease/infection are technically well defined. The design of
surveillance programmes to prove the absence of NAIV infection/circulation needs to be carefully
followed to avoid producing results that are either insufficiently reliable to be accepted by the OIE
or international trading partners, or excessively costly and logistically complicated. The design of any
surveillance programme, therefore, requires inputs from professionals competent and experienced in
this field.
2. Clinical surveillance
Clinical surveillance aims at the detection of clinical signs of NAI at the flock level. Whereas
significant emphasis is placed on the diagnostic value of mass serological screening, surveillance
based on clinical inspection should not be underrated. Monitoring of production parameters, such as
increased mortality, reduced feed and water consumption, presence of clinical signs of a respiratory
disease or a drop in egg production, is important for the early detection of NAIV infection. In some
cases, the only indication of LPNAIV infection may be a drop in feed consumption or egg
production.
Clinical surveillance and laboratory testing should always be applied in series to clarify the status of
NAI suspects detected by either of these complementary diagnostic approaches. Laboratory testing
may confirm clinical suspicion, while clinical surveillance may contribute to confirmation of positive
serology. Any sampling unit within which suspicious animals are detected should be classified as
infected until evidence to the contrary is produced.
Identification of suspect flocks is vital to the identification of sources of NAIV and to enable the
molecular, antigenic and other biological characteristics of the virus to be determined. It is essential
that NAIV isolates are sent regularly to the regional Reference Laboratory for genetic and antigenic
characterization.
3. Virological surveillance
Virological surveillance using tests described in the Terrestrial Manual should be conducted:
d) to test ‘normal’ daily mortality, to ensure early detection of infection in the face of vaccination
or in establishments epidemiologically linked to an outbreak.
4. Serological surveillance
Serological surveillance aims at the detection of antibodies against NAIV. Positive NAIV antibody
test results can have four possible causes:
a) natural infection with NAIV;
b) vaccination against NAI;
c) maternal antibodies derived from a vaccinated or infected parent flock are usually found in the
yolk and can persist in progeny for up to 4 weeks;
d) positive results due to the lack of specificity of the test.
It may be possible to use serum collected for other survey purposes for NAI surveillance. However,
the principles of survey design described in these guidelines and the requirement for a statistically
valid survey for the presence of NAIV should not be compromised.
The discovery of clusters of seropositive flocks may reflect any of a series of events, including but
not limited to the demographics of the population sampled, vaccinal exposure or infection. As
clustering may signal infection, the investigation of all instances must be incorporated in the survey
design. Clustering of positive flocks is always epidemiologically significant and therefore should be
investigated.
If vaccination cannot be excluded as the cause of positive serological reactions, diagnostic methods
to differentiate antibodies due to infection or vaccination should be employed.
The results of random or targeted serological surveys are important in providing reliable evidence
that no NAIV infection is present in a country, zone or compartment. It is therefore essential that the
survey be thoroughly documented.
5. Virological and serological surveillance in vaccinated populations
The surveillance strategy is dependent on the type of vaccine used. The protection against AI is
haemagglutinin subtype specific. Therefore, two broad vaccination strategies exist: 1) inactivated
whole AI viruses, and 2) haemagglutinin expression-based vaccines.
In the case of vaccinated populations, the surveillance strategy should be based on virological and/or
serological methods and clinical surveillance. It may be appropriate to use sentinel birds for this
purpose. These birds should be unvaccinated, AI virus antibody free birds and clearly and
permanently identified. The interpretation of serological results in the presence of vaccination is
described in Article 3.8.9.7.
Article 3.8.9.4.
1. Countries declaring freedom from NAI or HPNAI for the country, zone or compartment
In addition to the general conditions described in the Terrestrial Code, a Member Country declaring
freedom from NAI or highly pathogenic notifiable avian influenza (HPNAI) for the entire country,
or a zone or a compartment should provide evidence for the existence of an effective surveillance
programme. The strategy and design of the surveillance programme will depend on the prevailing
epidemiological circumstances and should be planned and implemented according to general
conditions and methods described in this Appendix, to demonstrate absence of NAIV or HPNAIV
infection, during the preceding 12 months in susceptible poultry populations (vaccinated and
non-vaccinated). This requires the support of a laboratory able to undertake identification of NAIV
or HPNAIV infection through virus detection and antibody tests described in the Terrestrial Manual.
This surveillance may be targeted to poultry population at specific risks linked to the types of
production, possible direct or indirect contact with wild birds, multi-age flocks, local trade patterns
including live bird markets, use of possibly contaminated surface water, and the presence of more
than one species on the holding and poor biosecurity measures in place.
Article 3.8.9.5.
In addition to the general conditions described in Chapter 2.7.12., a country re-declaring for country, zone
or compartment freedom from NAI or HPNAI virus infection should show evidence of an active
surveillance programme depending on the epidemiological circumstances of the outbreak to demonstrate
the absence of the infection. This will require surveillance incorporating virus detection and antibody tests
described in the Terrestrial Manual. The use of sentinel birds may facilitate the interpretation of
surveillance results.
A Member Country declaring freedom of country, zone or compartment after an outbreak of NAI or
HPNAI (with or without vaccination) should report the results of an active surveillance programme in
which the NAI or HPNAI susceptible poultry population undergoes regular clinical examination and
active surveillance planned and implemented according to the general conditions and methods described
in these guidelines. The surveillance should at least give the confidence that can be given by a randomized
representative sample of the populations at risk.
Article 3.8.9.6.
The declaration of NAI free establishments requires the demonstration of absence of NAIV infection.
Birds in these establishments should be randomly tested using virus detection or isolation tests, and
serological methods, following the general conditions of these guidelines. The frequency of testing should
be based on the risk of infection and at a maximum interval of 21 days.
Article 3.8.9.7.
Poultry infected with NAI virus produce antibodies to haemagglutinin (HA), neuraminidase (NA),
nonstructural proteins (NSPs), nucleoprotein/matrix (NP/M) and the polymerase complex proteins.
Detection of antibodies against the polymerase complex proteins will not be covered in this Appendix.
Tests for NP/M antibodies include direct and blocking ELISA, and agar gel immunodiffusion (AGID)
tests. Tests for antibodies against NA include the neuraminidase inhibition (NI), indirect fluorescent
antibody and direct ELISA tests. For the HA, antibodies are detected in haemagglutination inhibition
(HI) and neutralization (SN) tests. The HI test is reliable in avian species but not in mammals. The SN
test can be used to detect subtype specific antibodies to the haemagglutinin and is the preferred test for
mammals and some avian species. The AGID test is reliable for detection of NP/M antibodies in
chickens and turkeys, but not in other avian species. As an alternative, blocking ELISA tests have been
developed to detect NP/M antibodies in all avian species.
The HI and NI tests can be used to subtype AI viruses into 15 haemagglutinin and 9 neuraminidase
subtypes. Such information is helpful for epidemiological investigations and in categorization of AI
viruses.
Poultry can be vaccinated with a variety of AI vaccines including inactivated whole AI virus vaccines, and
haemagglutinin expression-based vaccines. Antibodies to the haemagglutinin confer subtype specific
protection. Various strategies can be used to differentiate vaccinated from infected birds including
serosurveillance in unvaccinated sentinel birds or specific serological tests in the vaccinated birds.
AI virus infection of unvaccinated birds including sentinels is detected by antibodies to the NP/M,
subtype specific HA or NA proteins, or NSP. In poultry vaccinated with haemagglutinin expression-based
vaccines, antibodies are detected to the specific HA, but not any of the other AI viral proteins. Infection
is evident by antibodies to the NP/M or NSP, or the specific NA protein of the field virus. Poultry
vaccinated with inactivated whole AI vaccines may develop low titres of antibodies to NSP, but the titre
in infected birds will be markedly higher. Alternatively, usage of a vaccine strain with a different NA
subtype than the field virus can allow differentiation of vaccinated from infected birds (DIVA) by
detection of subtype specific NA antibodies of the field virus. Vaccines used should comply with the
standards of the Terrestrial Manual.
All flocks with seropositive results should be investigated. Epidemiological and supplementary laboratory
investigation results should document the status of NAI infection/circulation for each positive flock.
A confirmatory test should have a higher specificity than the screening test and sensitivity at least
equivalent than that of the screening test.
Information should be provided on the performance characteristics and validation of tests used.
1. The follow up procedure in case of positive test results if vaccination is used
In case of vaccinated populations, one has to exclude the likelihood that positive test results are
indicative of virus circulation. To this end, the following procedure should be followed in the
investigation of positive serological test results derived from surveillance conducted on
NAI-vaccinated poultry. The investigation should examine all evidence that might confirm or refute
the hypothesis that the positive results to the serological tests employed in the initial survey were not
due to virus circulation. All the epidemiological information should be substantiated and the results
should be collated in the final report.
Knowledge of the type of vaccine used is crucial in developing a serological based strategy to
differentiate infected from vaccinated animals.
a) Inactivated whole AI virus vaccines can use either homologous or heterologous neuraminidase
subtypes between the vaccine and field strains. If poultry in the population have antibodies to
NP/M and were vaccinated with inactivated whole AI virus vaccine, the following strategies
should be applied:
i) sentinel birds should remain NP/M antibody negative. If positive for NP/M antibodies,
indicating AI virus infection, specific HI tests should be performed to identify H5 or H7
AI virus infection;
ii) if vaccinated with inactivated whole AI virus vaccine containing homologous NA to field
virus, the presence of antibodies to NSP could be indicative of infection. Sampling should
be initiated to exclude the presence of NAIV by either virus isolation or detection of virus
specific genomic material or proteins;
iii) if vaccinated with inactivated whole AI virus vaccine containing heterologous NA to field
virus, presence of antibodies to the field virus NA or NSP would be indicative of infection.
Sampling should be initiated to exclude the presence of NAIV by either virus isolation or
detection of virus specific genomic material or proteins.
2. The follow up procedure in case of positive test results indicative of infection for determination of
infection due to HPNAI or LPNAI virus
The detection of antibodies indicative of a NAI virus infection as indicated in point a)i) above will
result in the initiation of epidemiological and virological investigations to determine if the infections
are due to HPNAI or LPNAI viruses.
Virological testing should be initiated in all antibody-positive and at risk populations. The samples
should be evaluated for the presence of AI virus, by virus isolation and identification, and/or
detection of influenza A specific proteins or nucleic acids (Figure 2). Virus isolation is the gold
standard for detecting infection by AI virus and the method is described in the Terrestrial Manual. All
AI virus isolates should be tested to determine HA and NA subtypes, and in vivo tested in chickens
and/or sequencing of HA proteolytic cleavage site of H5 and H7 subtypes for determination of
classification as HPNAI, LPNAI or LPAI (not notifiable) viruses. As an alternative, nucleic acid
detection tests have been developed and validated; these tests have the sensitivity of virus isolation,
but with the advantage of providing results within a few hours. Samples with detection of H5 and
H7 HA subtypes by nucleic acid detection methods should either be submitted for virus isolation,
identification, and in vivo testing in chickens, or sequencing of nucleic acids for determination of
proteolytic cleavage site as HPNAI or LPNAI viruses. The antigen detection systems, because of low
sensitivity, are best suited for screening clinical field cases for infection by Type A influenza virus
looking for NP/M proteins. NP/M positive samples should be submitted for virus isolation,
identification and pathogenicity determination.
Laboratory results should be examined in the context of the epidemiological situation. Corollary
information needed to complement the serological survey and assess the possibility of viral
circulation includes but is not limited to:
The entire investigative process should be documented as standard operating procedure within the
epidemiological surveillance programme.
The above diagram indicates the tests which are recommended for use in the investigation of poultry
flocks.
Key:
AGID Agar gel immunodiffusion
DIVA Differentiating infected from vaccinated animals
ELISA Enzyme-linked immunosorbant assay
HA Haemagglutinin
HI Haemagglutination inhibition
NA Neuraminidase
NI Neuraminidase inhibition
NP/M Nucleoprotein and matrix protein
NSP Nonstructural protein
SN Serum neutralization
S No evidence of NAIV
ANTIMICROBIAL RESISTANCE
APPENDIX 3.9.1.
Article 3.9.1.1.
Objective
Article 3.9.1.2.
4. Targeted surveillance is conducted through an active sampling scheme designed to meet programme
objectives. Passive surveillance is conducted when samples are submitted to a laboratory for testing
from sources outside the programme.
Article 3.9.1.3.
1. General aspects
Surveillance of antimicrobial resistance at regular intervals or ongoing monitoring of prevalence
changes of resistant bacteria of animal, food, environmental and human origin, constitutes a critical
part of a strategy aimed at limiting the spread of antimicrobial resistance and optimising the choice of
antimicrobials used in therapy.
Monitoring of bacteria from products of animal origin intended for human consumption collected at
different steps of the food chain, including processing, packing and retailing, should also be
considered.
2. Sampling strategies
a) General
i) Sampling should be conducted on a statistical basis. The sampling strategy should assure:
- the sample representativeness of the population of interest;
- the robustness of the sampling method.
ii) The following criteria are to be considered:
- sample size;
- sample source (animal, food, animal feed);
- animal species;
- category of animal within species (age group, production type);
- stratification within category;
- health status of the animals (healthy, diseased);
- random sample (targeted, systematic);
- sample specimens (faecal, carcass, processed food).
b) Sample size
The sample size should be:
i) large enough to allow detection of existing resistance,
ii) not excessively large to avoid waste of resources.
Details are provided in table 1. Sampling fall follow standard operating procedures.
3. Sample sources
a) Animals
Each Member Country should examine its livestock production systems and decide, after risk
analysis, the relative importance of antimicrobial resistance and its impact on animal and human
health.
Categories of livestock that should be considered for sampling include cattle and calves,
slaughter pigs, broiler chickens, layer hens and/or other poultry and farmed fish.
b) Zoonotic bacteria
i) Salmonella
Salmonella should be sampled from cattle, pigs, broilers and other poultry. For the purpose
of facilitating sampling and reducing the concurrent costs, samples should preferably be
taken at the abattoir. Surveillance and monitoring programmes may also use bacterial
isolates from designated national laboratories originating from other sources.
Isolation and identification of bacteria and bacterial strains should follow internationally
accepted procedures.
All Salmonella isolates should be serotyped and, where appropriate, phage-typed according
to standard methods used at the nationally designated laboratories.
ii) Campylobacter
Campylobacter jejuni and C. coli can be isolated from the same samples as commensal
bacteria. Isolation and identification of these bacteria should follow internationally
accepted procedures. Campylobacter isolates should be identified to the species level.
Validated methods with appropriate reference strains are expected to become available in
the near future.
c) Commensal bacteria
Escherichia coli and enterococci are common commensal bacteria. These bacteria are considered to
constitute a reservoir of antimicrobial resistance genes, which may be transferred to pathogenic
bacteria causing disease in animals or humans. It is considered that these bacteria should be
isolated from healthy animals, preferably at the abattoir, and be monitored for antimicrobial
resistance.
a) Countries should designate a national reference centre that assumes the responsibility to:
i) coordinate the activities related to the resistance surveillance and monitoring programmes;
i) raw data;
Article 3.9.2.1.
Purpose
These guidelines are intended for use by OIE Member Countries to collect objective and quantitative
information to evaluate usage patterns by animal species, antimicrobial class, potency and type of use in
order to evaluate antimicrobial exposure.
Article 3.9.2.2.
Objectives
The information provided in these guidelines is essential for risk analyses and planning, can be helpful in
interpreting resistance surveillance data and can assist in the ability to respond to problems of
antimicrobial resistance in a precise and targeted way. This information may also assist in evaluating the
effectiveness of efforts to ensure prudent use and mitigation strategies (for example, by identifying
changes in prescribing practices for veterinarians) and to indicate where alteration of antimicrobial
prescribing practices might be appropriate, or if changes in prescription practice have altered the pattern
of antimicrobial use.
The continued collection of this basic information will also help give an indication of trends in the use of
animal antimicrobials over time and the role of these trends in the development of antimicrobial
resistance in animals.
For all OIE Member Countries, the minimum basic information collected should be the annual weight in
kilograms of the active ingredient of the antimicrobial(s) used in food animal production. In addition, the
type of use (therapeutic or growth promotion) and route of administration (parenteral or oral
administration) should be recorded.
Member Countries may wish to consider, for reasons of cost and administrative efficiency, collecting
medical, food animal, agricultural and other antimicrobial use data in a single programme. A consolidated
programme would also facilitate comparisons of animal use with human use data for relative risk analysis
and help to promote optimal usage of antimicrobials.
Article 3.9.2.3.
v) Further subdivision of these figures by season and region by a Member Country may be
useful (Note: This may be especially management conditions, or where animals are moved from one
locality to another during production).
vi) Further breakdown of data for analysis of antimicrobial use at the regional, local, herd and
individual veterinarian level may be possible using veterinary practice computer
management software as part of specific targeted surveys or audits. Analysis of this
information with the local or regional context could be useful for individual practitioners
and practices where specific antimicrobial resistance has been identified and feedback is
required.
b) Classes of antimicrobials
Nomenclature of antimicrobials should comply with international standards where available.
Decisions need to be made on what classes of antimicrobials should be considered and what
members of various antimicrobial classes should be included in the data collection programme.
These decisions should be based on currently known mechanisms of antimicrobial activity and
resistance of the particular antimicrobial and its relative potency.
c) Species and production systems
Countries should keep a register of all animal use of antimicrobials for individual food animal
species (cattle, sheep, goats, pigs, poultry, horses and fish) and for specific diseases. This will
help to identify possible nonauthorised usage.
3. Other important information
Breakdown of farm livestock into species and production categories, including total live weights,
would be most useful in any risk analysis or for comparison of animal antimicrobial use with human
medical use within and between countries. For example, the total number of food animals by
category and their weight in kilograms for food production per year (meat, dairy and draught cattle,
and meat, fibre, poultry and dairy sheep) in the country would be essential basic information.
Article 3.9.3.1.
Purpose
These guidelines provide guidance for the responsible and prudent use of antimicrobial agents in
veterinary medicine, with the aim of protecting both animal and human health. The Competent Authorities
responsible for the registration and control of all groups involved in the production, distribution and use
of veterinary antimicrobials have specific obligations.
Prudent use is principally determined by the outcome of the marketing authorisation procedure and by
the implementation of specifications when antimicrobials are administered to animals.
Article 3.9.3.2.
Prudent use includes a set of practical measures and recommendations intended to prevent and/or reduce
the selection of antimicrobial-resistant bacteria in animals to:
1. maintain the efficacy of antimicrobial agents and to ensure the rational use of antimicrobials in animals
with the purpose of optimising both their efficacy and safety in animals;
2. comply with the ethical obligation and economic need to keep animals in good health;
3. prevent, or reduce, as far as possible, the transfer of micro-organisms (with their resistance
determinants) within animal populations;
5. prevent or reduce the transfer of resistant micro-organisms or resistance determinants from animals
to humans;
6. maintain the efficacy of antimicrobial agents used in human medicine and prolong the usefulness of
the antimicrobials;
7. prevent the contamination of animal-derived food with antimicrobial residues that exceed the
established maximum residue limit (MRL);
8. protect consumer health by ensuring the safety of food of animal origin with respect to residues of
antimicrobial drugs, and the ability to transfer antimicrobial drug resistant micro-organisms to
humans.
Article 3.9.3.3.
1. Marketing authorisation
The national regulatory authorities are responsible for granting marketing authorisation. This should
be done in accordance with the provisions of the Terrestrial Code. They have a significant role in
specifying the terms of this authorisation and in providing the appropriate information to the
veterinarian.
2. Submission of data for the granting of the marketing authorisation
The pharmaceutical industry has to submit the data requested for the granting of the marketing
authorisation. The marketing authorisation is granted only if the criteria of safety, quality and efficacy
are met. An assessment of the potential risks and benefits to both animals and humans resulting
from the use of antimicrobial agents in food-producing animals should be carried out. The evaluation
should focus on each individual antimicrobial product and the findings not be generalised to the
class of antimicrobials to which the particular active principle belongs. Guidance on usage should be
provided for all dose ranges or different durations of treatment that are proposed.
3. Market approval
Regulatory authorities should attempt to expedite the market approval process of a new
antimicrobial in order to address a specific need for the treatment of disease.
4. Registration procedures
Countries lacking the necessary resources to implement an efficient registration procedure for
veterinary medicinal products (VMPs), and whose supply principally depends on imports from
foreign countries, should undertake the following measures:
a) check the efficacy of administrative controls on the import of these VMPs;
b) check the validity of the registration procedures of the exporting and manufacturing country as
appropriate;
c) develop the necessary technical co-operation with experienced authorities to check the quality
of imported VMPs as well as the validity of the recommended conditions of use.
Regulatory authorities of importing countries should request the pharmaceutical industry to provide
quality certificates prepared by the Competent Authority of the exporting and manufacturing country
as appropriate. All countries should make every effort to actively combat the manufacture,
advertisement, trade, distribution and use of unlicensed and counterfeit bulk active pharmaceutical
ingredients and products.
5. Quality control of antimicrobial agents
Quality controls should be performed:
a) in compliance with the provisions of good manufacturing practices;
b) to ensure that analysis specifications of antimicrobial agents used as active ingredients comply
with the provisions of approved monographs;
c) to ensure that the quality and concentration (stability) of antimicrobial agents in the marketed
dosage form(s) are maintained until the expiry date, established under the recommended storage
conditions;
d) to ensure the stability of antimicrobials when mixed with feed or drinking water;
e) to ensure that all antimicrobials are manufactured to the appropriate quality and purity in order
to guarantee their safety and efficacy.
c) the degree of cross-resistance within the class of antimicrobials and between classes of
antimicrobials;
d) the pre-existing level of resistance in the pathogens of human health concern (baseline
determination) in both animals and humans.
8. Establishment of acceptable daily intake, maximum residue level and withdrawal periods for
antimicrobial compounds
a) When setting the acceptable daily intake (ADI) and MRL for an antimicrobial substance, the
safety evaluation should also include the potential biological effects on the intestinal flora of
humans.
b) The establishment of an ADI for each antimicrobial agent, and an MRL for each animal-derived
food, should be undertaken.
c) For each VMP containing antimicrobial agents, withdrawal periods should be established in order
to produce food in compliance with the MRL, taking into account:
i) the MRL established for the antimicrobial agent under consideration;
ii) the composition of the product and the pharmaceutical form;
iii) the target animal species;
iv) the dosage regimen and the duration of treatment;
v) the route of administration.
d) The applicant should provide methods for regulatory testing of residues in food.
9. Protection of the environment
An assessment of the impact of the proposed antimicrobial use on the environment should be
conducted. Efforts should be made to ensure that the environmental impact of antimicrobial use is
restricted to a minimum.
10. Establishment of a summary of product characteristics for each veterinary antimicrobial product
(VAP)
The summary of product characteristics contains the information necessary for the appropriate use
of VAPs and constitutes the official reference for their labelling and package insert. This summary
should contain the following items:
a) active ingredient and class;
b) pharmacological properties;
c) any potential adverse effects;
d) target animal species and age or production category;
e) therapeutic indications;
f) target micro-organisms;
g) dosage and administration route;
h) withdrawal periods;
i) incompatibilities;
j) shelf-life;
k) operator safety;
l) particular precautions before use;
m) particular precautions for the proper disposal of un-used or expired products;
n) information on conditions of use relevant to the potential for selection of resistance.
b) Specific surveillance
Specific surveillance to assess the impact of the use of a specific antimicrobial may be
implemented after the granting of the marketing authorisation. The surveillance programme
should evaluate not only resistance development in target animal pathogens, but also in
food-borne pathogens and/or commensals. Such surveillance will also contribute to general
epidemiological surveillance of antimicrobial resistance.
12. Supply and administration of the antimicrobial agents used in veterinary medicine
The relevant authorities should ensure that all the antimicrobial agents used in animals are:
The relevant authorities should develop effective procedures for the safe collection and destruction
of unused or expired VAPs.
All advertising of antimicrobials should be controlled by a code of advertising standards, and the
relevant authorities must ensure that the advertising of antimicrobial products:
a) complies with the marketing authorisation granted, in particular regarding the content of the
summary of product characteristics;
The training of users of antimicrobials should involve all the relevant organisations, such as
regulatory authorities, pharmaceutical industry, veterinary schools, research institutes, veterinary
professional organisations and other approved users such as food-animal owners. This training
should focus on:
c) the need to observe responsible use recommendations for the use of antimicrobial agents in
animal husbandry in agreement with the provisions of the marketing authorisations.
15. Research
Article 3.9.3.4.
Article 3.9.3.5.
1. Retailers distributing VAPs should only do so on the prescription of a veterinarian or other suitably
trained person authorised in accordance with national legislation, and all products should be
appropriately labelled.
2. The guidelines on the responsible use of antimicrobials should be reinforced by retail distributors
who should keep detailed records of:
a) date of supply;
b) name of prescriber;
c) name of user;
d) name of product;
e) batch number;
f) quantity supplied.
3. Distributors should also be involved in training programmes on the responsible use of
antimicrobials, as defined in point 14 of Article 3.9.3.3.
Article 3.9.3.6.
Responsibilities of veterinarians
The concern of the veterinarian is to promote public health and animal health and welfare. The
veterinarian’s responsibilities include preventing, identifying and treating animal diseases. The promotion
of sound animal husbandry methods, hygiene procedures and vaccination strategies (good farming
practice) can help to minimise the need for antimicrobial use in food-producing animals.
Veterinarians should only prescribe antimicrobials for animals under their care.
1. Use of antimicrobial agents
The responsibilities of veterinarians are to carry out a proper clinical examination of the animal(s)
and then:
a) only prescribe antimicrobials when necessary;
b) make an appropriate choice of the antimicrobial based on experience of the efficacy of
treatment.
2. Choosing an antimicrobial agent
a) The expected efficacy of the treatment is based on:
i) the clinical experience of the veterinarian;
ii) the activity towards the pathogens involved;
iii) the appropriate route of administration;
iv) known pharmacokinetics/tissue distribution to ensure that the selected therapeutic agent is
active at the site of infection;
v) the epidemiological history of the rearing unit, particularly in relation to the antimicrobial
resistance profiles of the pathogens involved.
Should a first-line antimicrobial treatment fail or should the disease recur, a second line
treatment should ideally be based on the results of diagnostic tests.
To minimise the likelihood of antimicrobial resistance developing, it is recommended that
antimicrobials be targeted to pathogens likely to be the cause of infection.
On certain occasions, a group of animals that may have been exposed to pathogens may need to
be treated without recourse to an accurate diagnosis and antimicrobial susceptibility testing to
prevent the development of clinical disease and for reasons of animal welfare.
b) Use of combinations of antimicrobials should be scientifically supported. Combinations of
antimicrobials may be used for their synergistic effect to increase therapeutic efficacy or to
broaden the spectrum of activity.
3. Appropriate use of the antimicrobial chosen
A prescription for antimicrobial agents should indicate precisely the treatment regime, the dose, the
treatment intervals, the duration of the treatment, the withdrawal period and the amount of drug to
be delivered, depending on the dosage and the number of animals to be treated.
The off-label use of a veterinary antimicrobial drug may be permitted in appropriate circumstances
and should be in agreement with the national legislation in force including the withdrawal periods to
be used. It is the veterinarian’s responsibility to define the conditions of responsible use in such a
case including the therapeutic regimen, the route of administration, and the duration of the
treatment.
4. Recording
Records on veterinary antimicrobial drugs should be kept in conformity with national legislation.
Information records should include the following:
a) quantities of medication used;
b) a list of all medicines supplied to each food-producing animal holding;
c) a list of medicine withdrawal period;
d) a record of antimicrobial susceptibilities;
e) comments concerning the response of animals to medication;
f) the investigation of adverse reactions to antimicrobial treatment, including lack of response due
to antimicrobial resistance. Suspected adverse reactions should be reported to the appropriate
regulatory authorities.
Veterinarians should also periodically review farm records on the use of VAPs to ensure compliance
with their directions and use these records to evaluate the efficacy of treatment regimens.
5. Labelling
All medicines supplied by a veterinarian should be labelled according to national legislation.
6. Training
Veterinary professional organisations should participate in the training programmes as defined in
point 14 of Article 3.9.3.3. It is recommended that veterinary professional organisations develop for
their members species-specific clinical practice guidelines on the responsible use of VAPs.
Article 3.9.3.7.
1. Food-animal producers with the assistance of a veterinarian are responsible for implementing health
and welfare programmes on their farms (good farming practice) in order to promote animal health
and food safety.
2. Food-animal producers should:
a) draw up a health plan with the attending veterinarian that outlines preventative measures
(feedlot health plans, mastitis control plans, endo- and ectoparasite control and vaccination
programmes, etc.);
b) use antimicrobial agents only on prescription, and according to the provisions of the prescription;
c) use antimicrobial agents in the species, for the uses and at the dosages on the approved/registered
labels and in accordance with product label instructions or the advice of a veterinarian familiar
with the animals and the production site;
d) isolate sick animals, when appropriate, to avoid the transfer of pathogens; dispose of dead or
dying animals promptly under conditions approved by the relevant authorities;
e) comply wit the storage conditions of antimicrobials in the rearing unit, according to the
provisions of the leaflet and package insert;
f) address hygienic conditions regarding contacts between people (veterinarians, breeders, owners,
children) and the animals treated;
g) comply with the recommended withdrawal periods to ensure that residue levels in
animal-derived food do not present a risk for the consumer;
h) dispose of surplus antimicrobials under safe conditions for the environment; medicines should
only be used within the expiry date, for the condition for which they were prescribed and, if
possible, in consultation with the prescribing veterinarian;
i) maintain all the laboratory records of bacteriological and susceptibility tests; these data should
be made available to the veterinarian responsible for treating the animals;
j) keep adequate records of all medicines used, including the following:
i) name of the product/active substance and batch number;
ii) name of prescriber and/or the supplier;
iii) date of administration;
iv) identification of the animal or group of animals to which the antimicrobial agent was
administered;
v) clinical conditions treated;
vi) dosage;
vii) withdrawal periods;
viii) result of laboratory tests;
ix) effectiveness of therapy;
k) inform the responsible veterinarian of recurrent disease problems.
Article 3.9.4.1.
Guidelines for analysing the risks to animal and public health from antimicrobial resistant
micro-organisms of animal origin
1. Introduction
The use of antimicrobials for therapy, prophylaxis and growth promotion in animals can reduce their
efficacy in animal and human medicine, through the development of antimicrobial resistant strains of
pathogenic micro-organisms. This risk may be represented by the loss of therapeutic efficacy of one
or several antimicrobial drugs and includes the emergence of multi-resistant micro-organisms.
2. Objective
The principal aim of risk analysis for antimicrobial resistance in micro-organisms from animals is to
provide Member Countries with a transparent, objective and scientifically defensible method of
assessing and managing the human and animal health risks associated with the development of
resistance arising from the use of antimicrobials in animals.
3. The risk analysis process
The principles of risk analysis are described in Section 1.3. of this Terrestrial Code.
A qualitative risk assessment should always be undertaken. Its outcome will determine whether
progression to a quantitative risk assessment is feasible and/or necessary.
4. Hazard identification
For the purposes of this Appendix, the hazard is the resistance determinant that emerges as a result
of the use of a specific antimicrobial in animals. This definition reflects the development of
resistance in a species of pathogenic micro-organisms, as well as the development of a resistance
determinant that may be passed from one species of micro-organisms to another. The conditions
under which the hazard might produce adverse consequences include any scenarios through which
humans or animals could become exposed to a pathogen which contains that resistance determinant,
fall ill and then be treated with an antimicrobial that is no longer effective because of the resistance.
5. Risk assessment
The assessment of the risk to human and animal health from antimicrobial-resistant micro-organisms
resulting from the use of antimicrobials in animals should examine:
a) the likelihood of emergence of resistant micro-organisms arising from the use of
antimicrobial(s), or more particularly, production of the resistance determinants if transmission
is possible between micro-organisms;
b) consideration of all pathways and their importance, by which humans could be exposed to these
resistant micro-organisms or resistance determinants, together with the possible degree of
exposure;
c) the consequences of exposure in terms of risks to human and/or animal health.
Article 3.9.4.2.
Article 3.9.4.3.
4. Exposure assessment
The following factors should be considered in the exposure assessment:
- prevalence and trends of resistant micro-organisms in clinically ill and clinically unaffected
animals
- prevalence of resistant micro-organisms in feed /the animal environment
- animal-to-animal transmission of the resistant micro-organisms
- number/percentage of animals treated
- dissemination of resistant micro-organisms from animals (animal husbandry methods,
movement of animals)
- quantity of antimicrobial(s) used in animals
- treatment regimens (dose, route of administration, duration)
- survival capacity of resistant micro-organisms
- exposure of wild life to resistant micro-organisms
- disposal practices for waste products and the opportunity for animal exposure to resistant
micro-organisms or resistance determinants in those products
- capacity of resistant micro-organisms to become established in animal intestinal flora
- exposure to resistance determinants from other sources
- dose, route of administration and duration of treatment
- pharmacokinetics (metabolism, bioavailability, access to intestinal flora)
- cycling of resistant micro-organisms between humans, animals and the environment.
5. Consequence assessment
The following factors should be considered in the consequence assessment:
- dose-response relationships
- variation in disease susceptibility of exposed populations and subgroups of the populations
- variation and frequency of animal health effects resulting from loss of efficacy of antimicrobials
- changes in practices resulting from reduced confidence in antimicrobials
- associated cost
- perceived future usefulness of the drug (time reference).
6. Risk estimation
The following factors should be considered in the risk estimation:
- number of therapeutic failures due to resistant micro-organisms
- animal welfare
- economic cost
- deaths (total per year; probability per year or lifetime for a random member of the population or
a member of a specific more exposed sub-population)
- incidence of resistance observed in animals.
7. Risk management options and risk communication
Risk management options and risk communication have to be continuously monitored and reviewed
in order to ensure that the objectives are being achieved.
The relevant recommendations (Articles 1.3.2.5., 1.3.2.6. and 1.3.2.7.) in the Terrestrial Code apply.
A range of risk management options is available to minimize the emergence and spread of
antimicrobial resistance and these include both regulatory and non-regulatory risk management
options, such as the development of codes of practice concerning the use of antimicrobials in animal
husbandry. Risk management decisions need to consider fully the implications of these different
options for human health and animal health and welfare and also take into account economic
considerations and any associated environmental issues. Effective control of certain bacterial diseases
of animals will have the dual benefit of reducing the risks linked to antimicrobial resistance, in cases
where the bacterial disease under consideration has also developed antimicrobial resistance.
Appropriate communication with all stakeholders is essential throughout the risk assessment
process.
APPENDIX 4.1.1.
I. OWNER
II. DESCRIPTION
Species of animal:.................................................................................................................................................
Sex: .........................................................................................................................................................................
Breed: .....................................................................................................................................................................
Colour: ...................................................................................................................................................................
.................................................................................................................................................................................
.................................................................................................................................................................................
.................................................................................................................................................................................
Countries visited...................................................................................................................................................
over the past 2 years ............................................................................................................................................
as declared by the owner.....................................................................................................................................
(give dates).............................................................................................................................................................
.................................................................................................................................................................................
.................................................................................................................................................................................
I the undersigned declare herewith that I have vaccinated the animal described in Part II against
rabies as shown below. The animal was found to be healthy on the day of vaccination.
2. .........................
3. ........................
I the undersigned declare herewith that I have taken a blood sample from the animal described in
Part II and have received the following result from the official diagnostic laboratory which has
carried out the neutralising antibody titration test (see note 4).
Date of sampling Name and address of the Result of the Name (in capital letters)
(dd/mm/yy) official diagnostic antibody titration test and
laboratory (in International Units signature of the
[IU]/ml) veterinarian
(see note 6)
Date Name (in capital letters) and Name (in capital letters) and
(dd/mm/yy) signature of the veterinarian signature of the Official
(see note 6) Veterinarian
NOTE
1. The identification number stated in the certificate should be identical to that which can be found on
the animal. When electronic identification is used, the type of microchip and the name of the
manufacturer should be specified.
2. Only inactivated virus vaccines are authorised for international movements of dogs and cats.
3. In the case of a primary vaccination, the animal should have been vaccinated not less than 6 months
and not more than 1 year prior to its introduction into the importing country; the vaccination should
have been carried out when the animal was at least 3 months old.
In the case of a booster vaccination, the animal should have been vaccinated not more than 1 year
prior to its introduction into the importing country.
4. The animal should have been subjected not less than 3 months and not more than 24 months prior
to its introduction into the importing country, to a neutralising antibody titration test. It should be
carried out by an official diagnostic laboratory approved by the Competent Authority of the
exporting country. The animal's serum should contain at least 0.5 International Units (IU)/ml.
5. The clinical examination referred to in Part VI of the certificate must be carried out within 48 hours
of shipment.
The Competent Authority of the importing country may require the placing of the animals which
do not comply with any of the above-mentioned conditions in a quarantine station located on its
territory; the conditions of stay in quarantine are laid down by the legislation of the importing
country.
6. If the veterinarian whose name and signature appear on the certificate is not an official veterinarian,
his signature must be authenticated in the relevant column by the signature and stamp of an official
veterinarian. The expression 'Official Veterinarian' means a civil service veterinarian or a specially
appointed veterinarian, as authorised by the Veterinary Administration of the country.
7. If so required, the certificate should be written in the language of the importing country. In such
circumstances, it should also be written in a language understood by the certifying veterinarian.
The undersigned Official Veterinarian certifies that the animal/s described above and examined on this
day:
Official stamp:
Signature: ..................................................................................................................................................
2 These conditions are agreed between the Veterinary Services of the importing and exporting
countries in accordance with the options provided in this Terrestrial Code.
Species: .............................................................................................................................................................................
Breed: ................................................................................................................................................................................
Name: ...............................................................................................................................................................................
Date of birth: ...................................................................................................................................................................
Place of birth: ..................................................................................................................................................................
Registered entry in the herd/stud book: .....................................................................................................................
Date of approval of animal for artificial insemination purposes: ...........................................................................
............................................................................................................................................................................................
Name and address of exporter (artificial insemination centre or exporting owner): ..........................................
............................................................................................................................................................................................
............................................................................................................................................................................................
V. Sanitary information
Official stamp:
Signature: ..................................................................................................................................................
2 These conditions are agreed between the Veterinary Services of the importing and exporting
countries in accordance with the options provided in this Terrestrial Code.
Marks and
Species Age Sex Breed
description
The undersigned Official Veterinarian certifies that the animal/s described above and examined on this
day:
Official stamp:
Signature: ..................................................................................................................................................
2 These conditions are agreed between the Veterinary Services of the importing and exporting
countries in accordance with the options provided in this Terrestrial Code.
INTRODUCTION
The object is to establish criteria which will assist in the unrestricted movement of competition horses
between countries or zones of countries, while still protecting the health status of the respective countries
or zones. To achieve this aim, it is intended that the passport of any competition horse shall serve as a
unique identification document including harmonised information in the form of records of vaccinations
and results of laboratory tests.
In addition to the passport, a separate veterinary certificate may be required by the importing country.
1. Details of ownership
Information regarding the name and address of the owner of the horse should be indicated
according to Appendix A, and be authenticated by the National Federation issuing the passport.
The horse should be identified by the competent authority according to Appendices B and C.
3. Movement records
The identification of the horse should be checked at each time it is required by rules and regulations
and recorded in accordance with Appendix D.
4. Vaccination record
All vaccinations should be recorded according to Appendix E (equine influenza only) and
Appendix F (all other vaccinations).
The result of every test undertaken for a transmissible disease will be recorded according to
Appendix G.
Appendix H is a document which outlines the basic health requirements which apply to the international
movement of competition horses.
For the movement of competition horses between countries or zones of countries with a different health
status, Veterinary Services may require additional veterinary certification.
The reverse side of Appendix H lists diseases which may be considered for inclusion in the veterinary
certificate.
Appendix A
Date Cachet de la
d'enregistrement Nationalité Fédération
Nom du Adresse du Signature du
par du équestre nationale
propriétaire propriétaire propriétaire
la Fédération propriétaire et signature
équestre nationale officielle
Appendix B
(1) N° d'identification :
Identification No.:
N° de identificación:
Appendix C
Tête :
Head:
Cabeza:
Ant. G. : Ant. D. :
Foreleg L.: Foreleg R.:
Ant. I.: Ant. D.:
Post. G. : Post. D. :
Hindleg L.: Hindleg R.:
Post. I.: Post. D.:
Appendix D
Purpose of control
Signature, name (in capital letters) and
Date Town and country (event, veterinary certificate,
status of official verifying the identification
etc.)
Appendix E
Numéro de
lot Name (in capital letters) and signature of
Country Nom
Date Place Batch the veterinarian
Name
Fecha Lugar number Nombre (en letras mayúsculas) y firma del
País Nombre
Número de veterinario
lote
Appendix F
Numéro de
lot Name (in capital letters) and
Nom Maladie(s)
Date Place Country Batch signature of the veterinarian
Name Disease(s)
Fecha Lugar País number Nombre (en letras mayúsculas)
Nombre Enfermedad(es)
Número de y firma del veterinario
lote
Appendix G
Official
Name (in capital
Transmissible laboratory to
letters) and
Date diseases Type of test Result of test which
signature of
tested for sample
Veterinarian
transmitted
Laboratorio
Enfermedades Nombre (en letras
Tipo de Resultado del oficial que ha
Fecha transmisibles mayúsculas) y firma
examen examen analizado la
examinadas del veterinario
muestra
Appendix H
Je soussigné certifie(1) que le cheval décrit dans le passeport n° .......... délivré par .......... satisfait aux conditions
suivantes :
I, the undersigned, certify(1) that the horse described in the Passport No. .......... issued by .......... meets the
following requirements:
El que suscribe certifica(1) que el caballo descrito en el pasaporte n° .......... extendido por .......... cumple con los
siguientes requisitos:
(a) il a été examiné ce jour, ne présente aucun signe clinique de maladie et est apte au transport ;
(a) it has been examined today, shows no clinical sign of disease and is fit for transport;
(a) ha sido examinado hoy, no presenta ningún signo clínico de enfermedad y se encuentra en condiciones de ser
transportado;
(b) il n'est pas destiné à l'abattage dans le cadre d'un programme national d'éradication d'une maladie
transmissible ;
(b) it is not intended for slaughter under a national programme of transmissible disease eradication;
(b) no ha sido destinado al sacrificio sanitario en el marco de un programa nacional de erradicación de una
enfermedad transmisible;
(c) il ne provient pas d'une écurie mise en interdit pour des raisons zoosanitaires et n'a pas été en contact avec des
équidés d'une écurie de ce type ;
(c) it does not come from a holding which was subject to prohibition for animal health reasons nor had contact
with equidae from a holding which was subject to such prohibition;
(c) no procede de una cuadra sujeta a interdicción por razones zoosanitarias ni ha estado en contacto con équidos
procedentes de una cuadra sujeta a interdicción;
(d) à ma connaissance, après avoir dûment enquêté, il n'a pas été en contact avec des équidés atteints d'une maladie
transmissible au cours des 15 jours précédant l'embarquement.
(d) to the best of my knowledge and after due inquiry, it has not been in contact with equidae suffering from
transmissible disease during 15 days prior to embarkation.
(d) según me consta, tras haber efectuado las indagaciones pertinentes, no ha estado en contacto con équidos
afectados de enfermedades transmisibles durante los 15 días anteriores a su embarque.
For special epizootic reasons a separate Name (in capital letters) and
Date Place veterinary certificate accompanies this signature
passport. of official veterinarian
(1) Ce document doit être signé dans les 48 heures précédant le déplacement international du
cheval.
(1) The document should be signed within the 48 hours prior to international movement of the
horse.
(1) Este documento debe ser firmado 48 horas antes del desplazamiento internacional del
caballo.
1 For the movement of competition horses between countries or zones of countries with a different health
status, Veterinary Services may require additional veterinary certification.
The undersigned Official Veterinarian certifies that the birds described above and examined on this day:
Official stamp:
Signature: ..................................................................................................................................................
1 These conditions are agreed between the Veterinary Services of the importing and exporting
countries in accordance with the options provided in this Terrestrial Code.
The undersigned Official Veterinarian certifies that the day-old birds1 or hatching eggs1:
Official stamp:
Signature: ..................................................................................................................................................
2 These conditions are agreed between the Veterinary Services of the importing and exporting
countries in accordance with the options provided in this Terrestrial Code.
The undersigned Official Veterinarian certifies that the animal/s described above and examined on this
day:
Official stamp:
Signature: ..................................................................................................................................................
1 These conditions are agreed between the Veterinary Services of the importing and exporting
countries in accordance with the options provided in this Terrestrial Code.
I. Identification
Peculiarities Characteristics
Breed
Kind1 Number and Marks or age
variety Packing Accompanying
or weight or
material products
surface, etc.
II. Origin
III. Destination
a) at the time of shipment, the exported bees and/or brood-combs showed no symptom of any of the
contagious bee diseases listed by the OIE;
b) the breeding apiary of origin is officially approved and controlled by the Authority of the zone
responsible for the application of the sanitary measures and special breeding techniques
recommended by the OIE;
c) the breeding apiary of origin has been recognised as being free from contagious bee diseases for at
least the past 2 years with regard to varroosis and for at least the past 2 years with regard to the other
bee diseases listed by the OIE;
d) in the zone of origin, the arrangements for sanitary surveillance, as recommended by the OIE, have
been continuously applied for at least the past 2 years under the control of the veterinary service or
of a sanitary service operating under its authority;
e) the packing material and accompanying products come directly from the exporting breeding apiary
and have not been in contact with diseased bees or brood-combs, nor with any products or
equipment which are contaminated or extraneous to the exporting apiary.
Official stamp:
Signature: ..................................................................................................................................................
1 Hive with bees, swarm, consignment of bees (worker bees, drones), queen bees, brood-combs,
royal cells, etc.
APPENDIX 4.2.1.
............................................................................................................................................................................................
a) the meat1, packages of meat1 referred to above is/are stamped, thereby attesting that all the meat
comes from animals or birds slaughtered in abattoirs;
Official stamp:
Signature: ..................................................................................................................................................
2 These conditions are agreed between the Veterinary Services of the importing and exporting
countries in accordance with the options provided in this Terrestrial Code.
The above mentionned products are being sent from (place of dispatch) ...........................................................
to (country and place of destination) ...........................................................................................................................
Nature and identification of means of transport: ......................................................................................................
............................................................................................................................................................................................
Name and address of exporter: ....................................................................................................................................
............................................................................................................................................................................................
Name and address of consignee: ..................................................................................................................................
............................................................................................................................................................................................
............................................................................................................................................................................................
The undersigned Official Veterinarian certifies that the products described above satisfy the following
requirements1:
Official stamp:
Signature: ..................................................................................................................................................
1 These conditions are agreed between the Veterinary Services of the importing and exporting
countries in accordance with the options provided in this Terrestrial Code.