EU written comments on the reports of Terrestrial and Aquatic Animal Health Standard Commission meetings of September 2009, with reference to the Chapters in the OIE Terrestrial and Aquatic Codes, which will be for discussion at their next meetings in February 2010. – Coordination of the EU position - Hoofdinhoud

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COUNCIL OF THE EUROPEAN UNION

Brussels, 18 December 2009

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OUTCOME OF PROCEEDINGS

from:

on:

Subject :

Working Party of Chief Veterinary Officers 8 December 2009

EU written comments on the reports of Terrestrial and Aquatic Animal Health Standard Commission meetings of September 2009, with reference to the Chapters in the OIE Terrestrial and Aquatic Codes, which will be for discussion at their next meetings in February 2010. – Coordination of the EU position

• 1. 

  On the basis of the draft comments provided by the Commission, the Working Party of Chief Veterinary Officers met on 8 December 2009 to agree on a EU position.

2.

The discussion led to the following conclusions:

(a) The Presidency stated that there was an agreement on the texts under examination, as amended at the meeting and that this final version could be forwarded to the OIE¹.

The final version of the EU comments is presented in the Annexes.

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(b) The Working Party adhered to the position traditionally adopted in favour of forwarding letters signed jointly by the Presidency and the Commission to communicate to the OIE the comments to be made on behalf of the Member States¹.

¹         The Commission representative asked that the following statement be entered in the outcome of proceedings:

"The Commission considers that the procedure followed for forwarding the EU comments to the World Organisation for Animal Health (both by the Presidency, on behalf of the Member States, and by the Commission) does not correspond to the procedures usually followed in similar cases (notably in the case of the Codex Alimentarius). The fact that the EU only has observer status with an international organisation does not prevent the Commission on its own from forwarding the EU comments.

The Commission accordingly considers that the procedure followed in the case in question cannot constitute a precedent likely to be invoked for forthcoming OIE sessions or in other similar circumstances".

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Original: English September 2009

REPORT OF THE MEETING OF THE OIE TERRESTRIAL ANIMAL HEALTH STANDARDS COMMISSION

Paris, 7–18 September 2009

The OIE Terrestrial Animal Health Standards Commission (the Code Commission) met at the OIE Headquarters in Paris from 7 to 18 September 2009.

The members of the Code Commission are listed in Annex I and the agenda adopted is in Annex II.

The Code Commission reviewed the documents identified in the agenda, addressing comments that Members had submitted by August 7 2009 and amended texts in the OIE Terrestrial Animal Health Code (the Terrestrial Code) where appropriate. The amendments are shown in the usual manner by double underline and strikeout and may be found in the Annexes to the report. In Annexes XI (collection and processing of laboratory rodent and rabbit embryos /ova), XVIII (Anthrax) and XX (foot and mouth disease), the amendments made at this meeting (September 2009) are shown with a coloured background to distinguish them from those made prior to the 77^th OIE General Session in May 2009.

Members should note that, unless stated otherwise, texts submitted for comment may be proposed for adoption at the 78^th OIE General Session. Depending on the comments received on each text, the Code Commission will identify the texts proposed for adoption in May 2010 in the report of its February 2010 meeting.

The Code Commission strongly encourages Members to participate in the development of the OIE’s international standards by submitting comments on this report. It would be very helpful if comments were submitted as specific proposed text changes, supported by a scientific rationale. Proposed deletions should be indicated in ‘strikeout’ and proposed additions with ‘double underline’. Members should not use the automatic ‘track-change’ function provided by word processing software as such changes are lost in the process of collating Members’ submissions into the Code Commission’s working documents. Comments on this report must reach OIE Headquarters by 8 January 2010 to be considered at the 8 February 2010 meeting of the Code Commission. Comments should be sent to the International Trade Department at: trade.dept@oie.int.

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A. MEETING WITH THE DIRECTOR GENERAL

The Code Commission met with Dr Vallat and discussed a number of important issues.

Standards and guidelines of the OIE: In response to Members’ questions and to avoid confusion, it was decided that all texts in the Codes and Manuals would be considered to be ‘standards’ while texts found outside the Codes and Manuals (for example, on the OIE internet site) would be considered as ‘guidelines’ or ‘recommendations’.

Delisted diseases: the joint meeting discussed and agreed that all chapters and references to diseases no longer listed by the OIE should be removed from the Code. Relevant information on delisted diseases could be maintained in other locations (e.g. on the OIE internet site) but unless these were updated regularly they could become obsolete. However, Dr Vallat noted that references to delisted diseases could be maintained in the Manuals as Members could find this information useful and relevant. The following disease chapters were proposed for deletion (see Annex XXXIII):

Chapter 11.4.      Bovine cysticercosis

Chapter 11.10.    Dermatophilosis

Chapter 12.4.      Epizootic lymphangitis

Chapter 12.12.    Horse mange

Chapter 12.13.    Horse pox

Chapter 15.2.      Atrophic rhinitis of swine

Chapter 15.6.      Teschovirus encephalomyelitis.

On the recognition of country/zone freedom from equine diseases, Dr Vallat noted that an ad hoc group under the SCAD would be convened to address the issue of disease freedom on a disease by disease basis. He also indicated that the ad hoc Group would start with African horse sickness and could then consider glanders.

On the issue of commodity based trade, Dr Vallat emphasised that this is a priority for the OIE and encouraged the Code Commission to continue working on this issue.

Dr Vallat noted that bee diseases are of increasing concern because of the implications for food production and the environment. He noted that an ad hoc group would be convened to review the existing disease chapters to ensure that they address all relevant issues.

The Code Commission examined the Draft 5^th Strategic Plan and provided comments to the Director General.

The Code Commission acknowledged comments submitted by Argentina, Australia, Canada, Chinese Taipei, the European Union (EU), Japan, Korea (Rep. of), Kenya, Kuwait, New Zealand, Philippines, South Africa, Switzerland, Thailand, Uganda and the United States of America (USA). The Code Commission also considered comments provided by an industry association.

B. JOINT MEETING OF THE CODE COMMISSION AND THE SCIENTIFIC COMMISSION

The Code Commission and the Scientific Commission for Animal Diseases (SCAD) held a joint meeting on 9 September 2009 and discussed several important points. Dr William Karesh (Chair of the OIE Wildlife Working Group) attended this meeting. A summary of these discussions appears below.

• 1. 

  Animal health surveillance

Dr Bruckner, President of the SCAD, explained that the OIE Wildlife Working Group and the ad hoc Group on Epidemiology had been asked to provide advice on the development of an OIE policy on wildlife, including aspects relating to surveillance, treatment of wildlife in the relevant disease chapters, and trade implications of finding infection in wild populations. Dr Karesh commented that there was a need to rethink how the OIE refers to pathogens and diseases, reflecting the fact that some important pathogens readily infect multiple species. Dr Karesh also raised the possibility of developing text in the Code on epizootic haemorrhagic disease (EHD), as this

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is an important OIE listed disease of wildlife that affects cattle; it should be taken into account in the diagnosis and management of bluetongue.

• 2. 

  Foot and mouth disease

It was confirmed that the SCAD would consider OIE Members’ comments on modifications to the four disease questionnaires and provide advice to the Code Commission. On compartmentalisation, Dr Thiermann indicated that the Code Commission did not see a need, at this time, for the SCAD to provide advice for eventual inclusion in the Code on the implementation of compartmentalisation for foot and mouth disease (FMD) nor for other specific diseases. On beef casings, Dr Bruckner stated that the SCAD had received advice from experts that confirmed that the procedures used to render small ruminant and porcine casings safe are also effective for beef casings. In reply to the question of the Philippines for advice on the required coverage of an animal population with FMD vaccine, Dr Bruckner stated that it would be difficult to provide definitive advice to cover all situations but that, as already stated in the Terrestrial Code (Article 8.5.44.), as a general rule, at least 80% of the population targeted for vaccination should be vaccinated in order to consider that coverage was adequate.

• 3. 

  Swine vesicular disease

Dr Bruckner indicated that the SCAD would seek advice from an ad hoc group and the OIE Wildlife Working Group to review the comments of OIE Members on this chapter and provide advice to the Code Commission. Dr Kahn confirmed that the International Trade Department would then align the format of the revised swine vesicular disease chapter with the chapter on classical swine fever as adopted at the 77^th OIE General Session in May 2009.

• 4. 

  Avian influenza and Newcastle disease

Dr Thiermann indicated that the Code Commission had modified the recommendations on inactivation in these chapters in response to Member comments. Because some of the scientific references lead to different recommendations on time/temperature for inactivation, the SCAD would be asked to provide further advice.

• 5. 

  Classical swine fever

Dr Bruckner indicated that an expert would be asked to review the articles dealing with surveillance for classical swine fever with an approach similar to that taken to avian influenza and Newcastle disease. This would be referred to the ad hoc Group on Epidemiology.

• 6. 

  Other issues:

Anthrax: the Code Commission incorporated comments from an expert and from the SCAD and made appropriate modifications to Chapter 8.1. The Code Commission also requested additional advice from OIE Delegates regarding practical measures used under field conditions to inactivate B. anthracis spores in dung, manure and bedding.

Bluetongue: SCAD will continue to seek advice from experts on the points raised by Members on maternal transmission and the use of vaccines and would share with the Code Commission in due course.

Brucellosis: an ad hoc group will be convened to provide advice to the OIE, basing its approach on the approach taken to bovine tuberculosis.

African horse sickness: the comment provided by Kenya during the 77^th OIE General Session regarding the use of vaccine for African horse sickness was forwarded to the OIE Biological Standards Commission (BSC) for advice.

Equine influenza and equine viral arteritis: the International Trade Department had forwarded Member comments to four experts for review and their advice would be taken into account by the Code Commission.

Bee diseases: the Code Commission noted that the SCAD would convene an ad hoc group to review bee diseases and related concerns.

Rabies: Dr Knopf advised that an expert had been requested to review the current Terrestrial Code chapter and Member comments on rabies and an ad hoc group would be convened to draft a new/revised chapter on rabies.

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C. EXAMINATION OF MEMBER COMMENTS AND WORK OF RELEVANT EXPERT GROUPS

European Union (EU) Comments

The EU welcomes the work of the OIE TAHSC. Its comments have been incorporated in the Annexes for consideration by the Code Commission in its next meeting of February 2010.

Item 1. Glossary

The Code Commission reviewed comments from the EU, Japan, Kuwait, New Zealand, South Africa, Switzerland and the USA.

Inter alia, the Code Commission modified the definition of quarantine station in order to clarify that the presence of disease or infection in animals in a quarantine station does not affect the health status of the country or zone. The Code Commission deleted from the Glossary the definitions of ‘uncertainty’ and ‘variability’ as the definition of these terms is readily found in dictionaries of epidemiology.

The revised Glossary is provided at Annex III for Member comments.

Communication

In response to Member comments the Code Commission agreed to associate the proposed definitions related to communication with the outline of the draft chapter on communication developed by the ad hoc Group. The Code Commission invited Members to provide comments on the outline and definitions and undertook to forward these comments to the ad hoc Group to be taken into account in the further development of the chapter.

The outline and definitions are provided in Annex III for Member comments.

Item 2. Animal health surveillance (Chapter 1.4.)

The Code Commission reviewed comments of Australia, the EU and Kuwait, as well as advice of the SCAD and the ad hoc Group on Epidemiology, and made appropriate modifications to several articles, including Article 1.4.3. point 2 (e) ‘case definition’. The Code Commission will propose the inclusion of a definition for ‘wildlife’ once it receives advice from the OIE Wildlife Working Group.

The revised Chapter is provided at Annex IV for Member comments. Item 3. Surveillance of arthropod vectors of animal disease (Chapter 1.5.)

The Code Commission reviewed comments from Australia and the EU.

The revised Chapter is provided at Annex V for Member comments.

Item 4. Status for OIE listed diseases (Chapter 1. 6.)

The Code Commission reviewed comments from Argentina and New Zealand and made an appropriate modification to Article 1.6.1. Any changes to the disease status questionnaires in response to Member comments would be provided by the SCAD in due course.

The revised Chapter is provided at Annex VI for Member comments.

Item 5. Import risk analysis (Chapter 2.1. and report of the ad hoc Group)

The Code Commission reviewed a comment from the USA and made a text modification.

The Code Commission noted the report of the OIE ad hoc Group on Import Risk Analysis for Animals and Animal Products (Annex XLI).

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The revised Chapter is provided at Annex VII for Member comments. Item 6. Evaluation of Veterinary Services (Chapters 3.1. and 3.2.)

• a) 

  Draft revisions to Chapters 3.1. and 3.2.

The Code Commission reviewed amendments to Chapters 3.1. and 3.2. that had been proposed by the International Trade Department. The Code Commission supported the text amendments, which should help to highlight the importance of veterinary legislation as a key element of veterinary infrastructure and good governance.

The revised Chapters are provided at Annex VIII for Member comments.

• b) 

  Guidelines on Veterinary Legislation (OIE website)

The Code Commission noted and encouraged Members to review the “Guidelines on Veterinary Legislation”, which may be found on the OIE website at: http://www.oie.int/eng/oie/organisation/A_Guidelines_Vet%20Leg.pdf.

Dr Kahn informed the Code Commission that the first OIE Global Conference on Veterinary Legislation will be held in Djerba (Tunisia) on 6–8 December 2010. The announcement is available at:

http://www.oie.int/Eng/A_LEG_VET2010/ENG_first%20announcement.pdf

• c) 

  PVS Feedback session (9-10 December 2009) and meeting of the ad hoc Group on the Evaluation of Veterinary Services (11 December 2009)

Dr Kahn informed the Code Commission that the OIE was preparing a further revision of the OIE Tool for the Evaluation of Performance of Veterinary Services (OIE PVS Tool) and that the 11 December meeting of the ad hoc Group on the Evaluation of Veterinary Services would be preceded by a two-day seminar on expert experience in the evaluation of Veterinary Services.

Item 7. Design and implementation of systems for animal identification and traceability (Chapter 4.2.)

The Code Commission reviewed comments from Australia. The Code Commission noted that the concept of animal ownership may be very different in developing and developed countries and that the application of Chapter 4.2. needed to be considered in this light. The Code Commission made relevant amendments to the text.

The revised Chapter at Annex IX is provided for Member comments.

Item 8. Zoning and compartmentalisation

The Code Commission discussed the important concept of compartmentalisation and its incorporation in the Terrestrial Code as appropriate. This concept is valuable for disease control as well as for facilitating trade and can contribute to improving food security. The role of the Veterinary Authority in approving the compartment is of critical importance in both cases. Partnership with the private sector is however essential to ensure the correct application of the measures. The biosecurity plan documents the measures and the role of both the Veterinary Authority and the private sector in establishing and maintaining the compartment. If the compartment is being established for the purposes of trade, there must be a negotiation between the veterinary authority of the exporting and the importing country to recognise the correct application of measures. In all cases, the recommendations of the OIE should be followed. However, the OIE will not officially recognise free compartments. At this time the OIE does not propose to provide specific detailed recommendations in the Terrestrial Code on the provisions for implementing disease free compartments. However, practical guidance will be provided outside the Terrestrial Code via documents published on the OIE internet site.

• a) 

  Zoning and compartmentalisation (Chapter 4.3.)

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The Code Commission reviewed comments from the EU and advice of the SCAD and the ad hoc Group on Epidemiology. The Code Commission noted that the SCAD had referred the description of measures and functional aspects of the protection zone to the ad hoc Group on FMD.

The Code Commission modified the text as appropriate, including the addition of appropriate references to wildlife in Article 4.3.2. and of principles for defining a protection zone to Article 4.3.3. The EU recommendations for controls to provide for auditing of animal movements (Article 4.3.3., former point 5) were not accepted as the Code Commission considered that the important issue was the capacity to audit the history of the animals rather than tracing individual movements. However, the Code Commission reiterated the importance of animal identification and traceability for applying the concept of compartmentalisation.

• b) 

  Application of compartmentalisation (Chapter 4.4.)

The Code Commission reviewed comments from the EU and advice of the SCAD and amended Article 4.4.7.

The Code Commission noted that these two chapters could usefully be amalgamated to eliminate the duplication of texts and asked the International Trade Department to undertake this work once the content on compartmentalisation and on protection zones had been finalised.

The revised Chapters 4.3. and 4.4. are provided at Annex X for Member comments.

Item 9.

Semen and embryo chapters (Chapters 4.5. – 4.8. (inclusive) and Chapter 4.10.)

Professor Michel Thibier, Chair of the IETS HASSAC Committee, joined the Code Commission for this agenda item. The Code Commission discussed whether it would be useful to develop a new chapter on the collection and processing of equine semen. In the absence of requests from OIE Members, the Code Commission did not propose to undertake this work in the near future.

• a) 

  Collection and processing of bovine, small ruminant and porcine semen (Chapter 4.5.)

The Code Commission reviewed comments of the EU, extensive comments made by Australia, and the comments made by the USA at the 77^th OIE General Session.

In accordance with Australia’s comments and the advice of Prof. Thibier, the Code Commission renumbered Chapter 4.5. as Chapter 4.6. and made several amendments to the text, including modification of the terms ‘quarantine’, ‘quarantine station’ and ‘pre-quarantine’, the word ‘quarantine’ being replaced by ‘isolation’ throughout the chapter.

The Code Commission considered the recommendations made by the USA at the 77^th OIE General Session regarding testing for Campylobacter fetus subsp. venerealis and for Trichomonas fetus but, in the absence of a structured scientific rationale for the specific number of tests proposed, was not able to make the requested modifications.

The Code Commission decided not to accept the Australian proposal to modify several articles with respect to bluetongue because they were not consistent with the recommendations in Chapter 8.3. (Bluetongue).

As a matter of OIE policy, all references to border disease and Teschovirus encephalomyelitis were deleted from the chapter as these diseases are no longer listed by the OIE.

The revised Chapter is provided at Annex XI for Member comments.

• b) 

  General hygiene in semen collection and processing centres (Chapter 4.6.)

The Code Commission reviewed comments of Australia.

In accordance with Australia’s comments and the advice of Prof. Thibier, the Code Commission renumbered Chapter 4.6. as Chapter 4.5. The Code Commission did not accept the proposal to change

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the title of this chapter, as the title is appropriate to the contents of the chapter. The Code Commission made appropriate modifications to the text in Articles 4.6.1. and 4.6.2.

The revised Chapter is provided at Annex XI for Member comments.

• c) 

  Collection and processing of in vivo derived embryos from livestock and horses (Chapter 4.7.)

The Code Commission reviewed comments of the EU, Kuwait and South Africa.

Modifications were made to Articles 4.7.2. and 4.7.4.

In reply to a question from the EU, the Code Commission was advised by Prof. Thibier that the requirement in Article 4.7.5. for washing of no more than 10 embryos in a batch is the recommendation of the IETS Manual because all the studies demonstrating the safety of washed embryos have been conducted on batches of 10 embryos or less.

The Code Commission referred to the IETS the recommendation of South Africa regarding the listing of Mycobacterium paratuberculosis (in sheep) under category 3 in Article 4.7.14. Prof. Thibier confirmed that the IETS would consider this at its next meeting in January 2010.

The revised Chapter is provided at Annex XI for Member comments.

• d) 

  Collection and processing of in vitro produced embryos/oocytes from livestock and horses (Chapter 4.8.)

The Code Commission reviewed comments of the EU, Kuwait and Sudan (the 77^th OIE General Session).

In response to the EU comment on Articles 4.8.3., 4.8.4. and 4.8.5., the Code Commission advised that the risks associated with in vitro produced (and micro manipulated) embryos and oocytes are different to the risks associated with in vivo produced embryos and oocytes because of the loss of integrity of the zona pellucida and there is less scientific evidence for the in vitro products, hence the different recommendations.

The Code Commission accepted comments of the EU and of Kuwait and modified Article 4.8.2. and Article 4.8.4. accordingly.

The Code Commission did not accept the recommendation of Sudan to add congenital diseases to Chapter 4.8., as these diseases are outside the scope of the Terrestrial Code.

The Code Commission discussed the comments of the EU on the wording in this chapter ‘subject to veterinary restrictions for listed diseases’. The difficulty of determining which diseases on the OIE list should be considered as transmissible via in vitro produced embryos/oocytes, as distinct from in vivo produced embryos (that are the subject of specific IETS recommendations) makes it difficult to quickly resolve this issue. As an interim measure, the Code Commission decided to qualify the reference to listed diseases by adding the words ‘of concern (under study)’ and to ask the IETS to provide a proposed listing of the diseases that the OIE should take into account.

The Code Commission also asked the IETS to revise the articles on in vivo derived embryos in Chapter 8.3. (Bluetongue), Chapter 11.5. (Campylobacteriosis), Chapter 11.16. (Trichomonosis) and Chapter 14.9. (Scrapie).

The Code Commission modified the text of Article 4.8.5. to clarify that the testing described in this article is considered as supplemental to the procedures outlined elsewhere in the chapter.

The revised Chapter is provided at Annex XI for Member comments.

• e) 

  Collection and processing of laboratory rodent and rabbit embryos/ova (Chapter 4.10.) The Code Commission reviewed comments of the EU and Kuwait.

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The Code Commission accepted the recommendation of Kuwait on Article 4.10.2. and that of the EU on Article 4.10.5. and made appropriate modifications.

The revised Chapter is provided at Annex XI for Member comments.

Item 10. Health certification (Chapters 5.1., 5.2. and 5.10.)

The Code Commission reviewed comments from the EU and comments from Canada, Norway and the USA forwarded by the Aquatic Animal Health Standards Commission (Aquatic Animals Commission) in March 2009.

Harmonization of the two Codes is an important objective. However, the Code Commission noted that the Member comments to the Aquatic Animals Commission had not been submitted to the Terrestrial Code Commission. To facilitate the process of review and harmonization, the Commission encouraged Members to ensure that the comments submitted to the two Commissions are consistent.

In response to a comment from the EU, the Code Commission modified the text to exclude conditions for diseases that are not transmitted by the commodity concerned. The Commission also agreed that only one responsible veterinarian should sign the health certificate to avoid confusion in the importing country. The Code Commission noted that substitutions and other changes to certificates were not acceptable and therefore decided to maintain the text in point 8 of Article 5.2.3.

The Commission did not accept the proposed modification of Chapter 5.10. (Note for guidance on veterinary certificates) because the proposed addition of ‘general principles’ is already covered in Chapters 5.1. and 5.2 and the proposed deletions are normal requirements for border control, zoning, etc. However, it asked the Aquatic Animals Commission to consider introducing modifications to the OIE Aquatic Animal Health Code (Aquatic Code) as appropriate.

The revised Chapters are provided at Annex XII for Member comments.

Item 11. The control of hazards of animal health and public health importance in animal feed (Chapter 6.3.)

The Code Commission reviewed comments from Australia and the EU and modified the text as appropriate, including modification of the definition of ‘feed additive’.

Due to lack of specific information, the Code Commission maintained its position not to cover feed for bees in this chapter. It did not accept the proposed Australian modification of the definition of feed ingredients based on the fact that the text in the Terrestrial Code has been substantially harmonized with the Codex Code of Practice on Good Animal Feeding (CAC/RCP 54-2004). It did not accept the proposed addition of monitoring to contamination (point 12 of Article 6.3.4.) because this is covered by point 7 (Sampling and analysis) of Article 6.3.4.

The revised Chapters are provided at Annex XIII for Member comments.

Item 12. The control of hazards of animal health and public health importance in heat treated pet food (draft proposed new chapter)

The Code Commission acknowledged the submission of a draft proposed new chapter on pet food and supporting document by the Delegate of the USA.

The Code Commission considered that all animal feed, including pet food, should be covered in Chapter 6.3. and decided that after adoption of the provisions of the proposed new chapter, the text would be included in Chapter 6.3. and the footnotes deleted.

The proposed new Chapters are provided at Annex XIV for Member comments.

The supporting document is provided at Annex XLIII for information of Members on the international pet food industry, its practices, and the work in progress.

Item 13. Salmonellosis

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• a) 

  Report on the Codex Working Group meeting (Brazil 7–12 September 2009)

In 2007, the Codex Alimentarius Commission agreed that the development of guidelines for the control of Salmonella and Campylobacter in poultry was a priority. Later that year, at its 39^th session, the Codex Committee on Food Hygiene (CCFH) agreed on the approach to be taken in the development of draft Guidelines for control of Campylobacter and Salmonella spp. in chicken meat. The 40^th session of the CCFH requested the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) to provide the necessary scientific advice to ensure that the Guidelines were underpinned with the most robust scientific data. In response the FAO and WHO convened an expert meeting on 4–8 May 2009, in Rome, which the OIE attended.

The Physical Working Group met in Brazil on 7-11 September 2009 to further develop the proposed draft Guidelines for control of Campylobacter and Salmonella in chicken meat. The Working Group reviewed the draft Guidelines taking into account the FAO/WHO Expert meeting report and CAC Member comments.

The Guidelines incorporate a ‘production-to-consumption’ approach and identify all steps in the food chain where control measures could potentially be applied. The Guidelines are divided into three parts, the first on Good Hygiene Practices (GHPs), the second on hazard based controls and the third on risk based control measures. They include references to relevant OIE standards as the primary source of recommendations regarding the primary production phase and it is noted that the Codex Guidelines are supplementary to relevant OIE standards with regard to control measures during primary production. In addition, the Codex Working Group agreed to use OIE definitions where they exist. The proposed Guidelines include OIE definitions for competitive exclusion, epidemiological unit, establishment and flock. The OIE will continue to participate actively in the drafting and revision of the Guidelines according to the CAC procedures.

• b) 

  Biosecurity procedures in poultry production (revised Chapter 6.4.)

The Code Commission reviewed the report of the ad hoc Group on Salmonellosis (Annex XLII), including the revised Chapter 6.4. The Code Commission endorsed the work of the ad hoc Group, which had addressed Member comments and had reduced the amount of detail that was previously in this chapter. The resulting text addresses generically hygiene and biosecurity practices. If additional details on frequency and timing of measures are needed by Members, these could be developed and presented as guidelines outside the Terrestrial Code. Noting that the OIE had received one round of comments from Members on this text, the Code Commission decided to propose the revised chapter for adoption in May 2010.

The revised Chapter is provided at Annex XV for Member comments.

• c) 

  Prevention, detection and control of Salmonella in poultry (Chapter 6.5.)

The Code Commission received comments from the EU and South Africa.

The Code Commission reviewed the work of the ad hoc Group on Salmonellosis, including the revision of Chapter 6.5. The ad hoc Group had addressed Member comments and had also incorporated into Chapter 6.5. the three Articles from Chapter 6.6. (Salmonella Enteritidis and Salmonella Typhimurium in Poultry) thereby deleting Chapter 6.6.

Bearing in mind that the terminology ‘free from at least S. Enteritidis and S. Typhimurium’ was not clear and that concept of freedom from these pathogens has not been defined in the Terrestrial Code, the Code Commission modified Article 6.5.5.

The revised Chapter is provided at Annex XV for Member comments.

Item 14. Introduction to the recommendations for controlling antimicrobial resistance

The Code Commission reviewed comments from the EU and modified the text as appropriate.

The revised Chapter is provided at Annex XVI for Member comments.

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Item 15. Animal welfare

EU comments

The EU welcomes the work of the OIE to improve the existing animal welfare chapters as well as to develop new texts.

In particular, as regard the Draft Chapter on the "Use of animals in research and education", the EU wishes to acknowledge the progress made with the document, especially the inclusion of a specific section addressing the care and accommodation needs of the animals. The EU equally welcomes the number of previous EU comments have been taken into account in the latest draft.

The EU welcomes the work carried out by the OIE on the Draft Chapter on "Animal Welfare and Broiler Chicken Production" and on "Animal Welfare and Beef Cattle Production Systems" and acknowledges in particular their outcome-based approach. However the EU considers that improvements and additional details are needed to bring the draft texts in line with the previously adopted animal welfare chapters. In particular, the draft chapters contain recommendations expressed in broad and imprecise terms that are not easily usable by competent authorities, veterinarians and poultry producers. As a consequence, redrafting in the form of more precise recommendations is strongly suggested.

Specific EU comments on the proposed Draft and Revised Chapters are presented within the texts.

• a) 

  Use of animals in research and education (new draft chapter) and report of the 3^rd meeting of the ad hoc Group on Laboratory Animal Welfare (including OIE discussion paper on air transport of laboratory animals)

The Code Commission considered comments provided by Australia, Canada, Chinese Taipei, the EU, New Zealand, Switzerland and the USA, and from an animal welfare NGO.

The Code Commission acknowledged the work of the ad hoc Group and the extensive detailed information in its report (Annex XXXVIII). Noting that the draft chapter had been sent to Members for comment once and that the ad hoc Group had substantially addressed the comments provided, the Code Commission considered that the chapter could be proposed for adoption at the 78^th OIE General Session. This will be decided in light of the Code Commission’s consideration of Member comments at its February 2010 meeting. The Code Commission also noted that the list of references provided for Member information would not be included in the chapter when proposed for adoption. To facilitate the analysis of the new draft text, the Commission decided to present two versions of the text, one showing modifications in double underline and strikeout, and a second as clean text.

The revised Chapter is provided at Annex XVII for Member comments.

• b) 

  Animal welfare definition (Chapter 7.1.)

The Code Commission reviewed comments provided by Japan and comments submitted in the previous 12 months by the EU, Canada and the USA and during the 77^th OIE General Session. The Code Commission recalled that the definition had been adopted at the 76^th OIE General Session by consensus after lengthy discussion and, given that the comments under consideration could not readily be reconciled, the Code Commission decided that no changes to the definition were warranted.

• c) 

  Stray dog population control (Chapter 7.7.)

The Code Commission reviewed this chapter, which had been presented as an annex to the report of the 8^th meeting of the OIE Animal Welfare Working Group (AWWG), and, to ensure consistency with the rest of the Terrestrial Code, deleted the word ‘guidelines’ from the title and modified the heading of the table.

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The revised Chapter is provided at Annex XVII for Member comments.

• d) 

  Report of the 8th meeting of the OIE Animal Welfare Working Group

The Code Commission noted the report of the 8^th meeting of the AWWG (Annex XXXV). In regard to the future work programme of the AWWG, the Code Commission recommended that the AWWG focus its attention in the next year on the development of new chapters on laboratory animal welfare and on the welfare of livestock in the different production systems (starting with beef cattle and broiler chickens, then proceeding to dairy cattle, laying hens and pigs). In this work, the Code Commission encouraged the AWWG to develop texts of similar brevity to those on animal welfare in broiler chicken production and beef cattle production.

The Code Commission recommended that the highest priority for the AWWG is to finish the work on these new standards. The work on wildlife and the ethics of long distance transport should be deferred pending completion of these new standards.

• e) 

  Report of the OIE Electronic Consultation Group on Poultry Welfare

The Code Commission reviewed the recommendations of the Electronic Consultation Group (Annex XXXIX), which had proposed several amendments to Chapters 7.3., 7.4., 7.5. and 7.6. to address the specific requirements for transporting, killing and slaughtering poultry. The Code Commission acknowledged the thorough work of this group and made a number of modifications to the draft text received from the AWWG. However, the Code Commission expressed its concern that the excessive amount of detail was inappropriate in a standard of this kind. Such detail would be better published as guidelines i.e. outside the Terrestrial Code.

The revised Chapters are provided at Annex XVII for Member comments.

• f) 

  Report of the first meeting of the ad hoc Group on Animal Welfare and Broiler Chicken Production Systems

The Code Commission reviewed the report of the ad hoc Group (Annex XXXVI) and made several modifications to the text of the draft new chapter for clarification and to improve consistency with other Terrestrial Code chapters.

The Code Commission noted that the recommendations were limited to broilers in commercial production systems and do not cover broilers in informal production systems (such as backyard and village flocks). This does not mean to say that welfare is unimportant in backyard production systems. Rather, it reflects the difficulties that Veterinary Services face in making interventions in non commercial flocks. No definition has been proposed for backyard flocks but the Code Commission noted that this term has been used for several years (e.g. in the FAO Recommendations on the Prevention, Control and Eradication of Highly Pathogenic Avian Influenza (HPAI) in Asia, published in September 2004).

The revised Chapter is provided at Annex XVII for Member comments.

• g) 

  Report of the first meeting of the ad hoc Group on Animal Welfare and Beef Cattle Production Systems

The Code Commission reviewed the report of the ad hoc Group (Annex XXXVII).

The revised Chapter is provided at Annex XVII for Member comments.

The Code Commission commends the brevity of the texts on animal welfare in broiler chicken production and beef cattle production and recommends that these should be models for future concise animal welfare standards.

Item 16. Other horizontal chapters

• a) 

  Animal health measures applicable before and at departure (Chapter 5.4.)

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• b) 

  Border posts and quarantine stations in the importing country (Chapter 5.6.)

The Code Commission reviewed comments from Kuwait and South Africa, as well as advice from the SCAD, and modified the definition of quarantine station in the Glossary. The change proposed by Kuwait in Chapter 5.4. had already been adopted at the 77^th OIE General Session. Since the definition of quarantine station was modified, no modifications were required in Chapter 5.6.

Item 17. Anthrax (Chapter 8.1.)

The Code Commission reviewed the comments of Australia, Canada, the EU, Japan, New Zealand and Switzerland, the advice of an expert and comments provided by the SCAD.

On Article 8.1.1. (General Provisions), the Code Commission accepted a recommendation from New Zealand to clarify that the objectives of the recommendations in the chapter encompass animal health, human health and protection of the environment. After discussion with Prof. Thibier the Code Commission also modified the text to clarify that semen and in vivo derived cattle embryos collected and handled in accordance with relevant Terrestrial Code chapters are considered to be safe commodities.

Complementing this modification, the Code Commission included in the General Provisions a reference to the application of the recommendations in this chapter for international trade in commodities other than those considered to be safe.

On New Zealand’s recommendation, the Code Commission modified Article 8.1.6. to reflect that Veterinary Services should not be expected to certify the absence of clinical anthrax in sheep at the time of shearing as there is already certification to this effect for the flock of origin. Moreover, the existing text in points 2 and 3 of Article 8.1.6. is adequate for risk management.

On New Zealand’s recommendation, the Code Commission deleted point 3 (c) in Article 8.1.8. and presented the scientific rationale for point 3 (a) i.e. boiling for 60 minutes, as follows: “Table 1 in Spotts Whitney et al (2003) cites four different studies which demonstrated the destruction of Bacillus anthracis spores through boiling or other moist heat at 100°C for 5, 10 or 17 minutes.”

In response to a question from Japan, the Code Commission concluded that the recommendations in Article 8.1.9. are well supported by a published reference [Spotts Whitney et al (2003)] and the specifications are less prescriptive and more generally applicable than those specified in the WHO Guidelines.

The Code Commission modified points 1 – 4 (inclusive) of Article 8.1.11. in accordance with a comment from Japan. The Code Commission noted the question raised by Canada on the inactivation of spores in manure, dung and bedding. Given that there is no practical option currently available for the inactivation of anthrax spores in these materials, the Code Commission did not modify Article 8.1.12. and instead requested advice from Delegates as to practical alternatives for the treatment of manure, dung and bedding.

In response to a request from Japan for the background and rationale of the amendments proposed to Articles 8.1.14. and 8.1.15., the Code Commission responded that while the procedures cited are difficult to perform and may not always be totally effective, the recommendations are taken from the best currently available scientific references.

The revised chapter is provided at Annex XVIII for Member comments. References were left in the text for information of Members but these will be removed when the text is proposed for adoption.

Item 18. Bluetongue (Chapter 8.3.)

The Code Commission reviewed comments of Australia, the EU and South Africa, as well as advice provided by the SCAD and the International Embryo Transfer Society (IETS).

The Code Commission did not accept the EU recommendation on Article 8.3.1., because even if vaccination is performed and could be considered as a measure able to interrupt the transmission of bluetongue virus, the effectiveness of vaccination cannot be assured in the absence of surveillance. The Code Commission did not accept the EU recommendation to add ‘in vitro produced embryos and oocytes’ as neither the IETS nor the SCAD supported this recommendation. Insufficient scientific studies have been

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conducted to support the safety of such embryos and there is a small amount of evidence that they may be less safe than in vivo derived embryos.

The Code Commission accepted Australia’s recommendation to modify the text of point 2 in Article 8.3.3., but did not accept recommendation to modify point 1 of Article 8.3.3., noting that the critical issue of proximity to an infected country is appropriately addressed.

On the issue of changes to the status of a BTV free country/zone due to the importation of bluetongue seropositive animals (Article 8.3.3.), the Code Commission accepted an EU recommendation (supported by the SCAD) to modify text in point 3 (b) of Article 8.3.3. as it considered that this clarified the relevant provisions.

The Code Commission accepted the EU recommendations (supported by SCAD) to modify points 4 and 5 of Article 8.3.8. to make them consistent with the rest of the chapter.

The recommendation of South Africa on Articles 8.3.11. and 8.3.14. were not supported by SCAD and no changes were made to these texts.

The revised chapter is provided at Annex XIX for Member comments.

Item 19. Foot and mouth disease (Chapter 8.5.)

The Code Commission reviewed comments from Argentina, Chinese Taipei, the EU, Japan, Korea (Rep. of), Kuwait, New Zealand and the USA as well as the Philippines and Uganda (the 77^th OIE General Session). The Code Commission also received advice from the SCAD.

Noting that camelids are not ruminants, the Code Commission did not accept an EU recommendation to modify the text of Article 8.5.1.

In response to a recommendation from Argentina, the Code Commission modified the text in point 3 (c) of Article 8.5.2. and added new text at point 3 in Articles 8.5.3. and at point 4 in Article 8.5.4. and 8.5.5. to strengthen the provisions for protection zones.

The Code Commission agreed with Argentina on the need to modify the Spanish language version of Article 8.5.4. and the International Trade Department agreed to undertake this revision.

The Code Commission discussed the EU comment on Article 8.5.9. and made appropriate modifications to the text for clarification.

The Code Commission accepted a comment from Chinese Taipei on Article 8.5.10. related to the transport of live animals through infected areas and modified the text accordingly but did not accept Chinese Taipei’s recommendation on Article 8.5.20., as this modification had not been supported by the SCAD.

In response to the request of Uganda that Article 8.5.39. be extended to include bovine casings, and noting that the SCAD had received advice from an expert confirming that the procedures used to render small ruminant and porcine casings safe are also effective for beef casings, the Code Commission made an appropriate amendment.

In reply to the question of the Philippines for advice on the required coverage of an animal population with FMD vaccine, the SCAD indicated that it would be difficult to provide definitive advice to cover all situations but that, as a general rule, at least 80% of the population targeted for vaccination should be vaccinated in order to consider that vaccine coverage was adequate (as currently stated in Article 8.5.44.).

In response to a comment of Chinese Taipei on Article 8.5.46. point 2(a), the Code Commission sought advice from the BSC and modified the text accordingly to clarify that the NSP is a population test, not a test for individual animals, and that a positive result should be interpreted in terms of the number of positive animals, not the titre of antibody in the individual animal. On Article 8.5.46. point 2(b) and 2(d) the Code Commission modified the text for clarification as recommended by Chinese Taipei.

Compartmentalisation for FMD

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The Code Commission discussed the comments submitted by the EU, Japan, Korea (Rep. of), New Zealand and the USA regarding compartmentalisation for FMD. Several Members expressed opposition to the application of compartmentalisation to FMD. However, the Code Commission considered that there was still value in continuing to develop this work. The objective of a Member in implementing compartmentalisation may be to aid disease management and control. Notwithstanding the need for bilateral consultations to satisfy trading partners that the compartment is biosecure, the concept could also be of value in facilitating trade.

Dr Vallat has made it clear that the OIE does not intend currently to grant official recognition for FMD (or other disease) free compartments. However, subject to technical feasibility, the Code Commission considered that Members may wish to establish FMD free compartments for the purpose of supporting improvements in animal health status and for facilitating trade.

Noting that the SCAD had supported the concept that a compartment could be established either in an FMD free (with or without vaccination) or in an FMD infected zone, the Code Commission modified Article 8.5.5.bis by deleting ‘where vaccination is practised’ from the chapeau of this article.

The Code Commission noted that the FMD/FMDV surveillance requirements for a compartment are effectively the same as those for a zone. Accordingly, the Code Commission added text to the effect that surveillance in accordance with Chapters 4.3. and 4.4. should be implemented in the country or zone (as appropriate) in which the compartment is located.

Noting that an expert and the ad hoc Group on Epidemiology had developed a checklist for the implementation of a compartment for avian influenza and Newcastle disease (see http://www.oie.int/eng/info_ev/Other%20Files/En_final_Compartmentalisation_AI_ND_10_05_2007.pdf ), the Code Commission considered that it was not necessary at this time to include specific recommendations in the Terrestrial Code on the implementation of compartments for FMD but requested that the SCAD consider the development of a checklist for FMD similar to that provided for AI/ND.

The Code Commission also recommended that the checklist for AI/ND be updated, taking into account comments submitted by the EU.

The revised Chapter is provided at Annex XX for Member comments.

Item 20. Paratuberculosis (Chapter 8.10.)

The Code Commission noted a comment submitted by the EU.

In response to previous requests of Members, the Code Commission discussed with the SCAD the possibility of preparing a support document for guidance of Members. However, in view of the lack of adequate diagnostic tests for paratuberculosis, the Code Commission and the SCAD agreed that this work could not be undertaken in advance of further scientific development.

Noting that the content of Chapter 8.10. had been removed from the Terrestrial Code, the Code Commission decided that it could do no further work on paratuberculosis pending the future development of a supporting document.

Item 21. Rabies (Chapter 8.11.)

The Code Commission reviewed the comments from the EU and referred them to the ad hoc Group on Rabies, which will meet in January 2010 to consider replacing the current Chapter 8.10. The Code Commission undertook that, if possible, it would study the recommendations of the ad hoc Group and the SCAD at its February 2010 meeting.

Item 22. West Nile fever (Chapter 8.16.)

The Code Commission reviewed comments from the EU and the USA.

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The Code Commission accepted the deletion of chicken and turkey chicks under 12 days of age from the list of susceptible species and reorganised the recommendation on importation as appropriate. In making these modifications, the Code Commission took careful note of the following scientific evidence.

“There are only very limited and artificially controlled laboratory studies demonstrating infectivity, but there is absolutely no evidence that this occurs and poses any risk under field conditions. Chickens and turkeys, regardless of age, are a resistant species and as such, artificially laboratory-induced infection should not be used as a basis for imposing trade restrictions. Recommending restrictions on a species (chicks under 12 days old) that have shown not to play any epidemiological role in the transmission of the disease agent is not warranted.

Studies conducted by Swayne et al. (Avian Dis. 2000 Oct-Dec; 44(4) 932-7) showed that while turkeys do develop a viraemia, the level of virus is very low – less than what is needed to effectively infect mosquitoes. The data for that study showed that turkeys are not a significant amplifying host for infecting mosquitoes. Similarly, a study conducted by Senne et al. (Avian Dis. 2000 Jul-Sep; 44(3) 642-9) showed a lack of significant viraemia needed to infect mosquitoes. Another study by Buckley et al. (Virology Journal 2006, Sep; 3:71) failed to isolate either virus or viral RNA from the sera of infected chicks. Furthermore, there is no field evidence which shows that clinical disease develops in chickens or turkeys. Thus, although poultry of any age can become infected with WNV, they do not develop clinical disease, they cannot infect other birds or animals, and they do not act as a reservoir for the virus.”

The revised Chapter is provided at Annex XXI for Member comments.

Item 23. Diseases of bees (Chapters 9.1. – 9.6. (inclusive))

Noting that an ad hoc Group on Bee Diseases would be convened in January 2009 under the SCAD and the BSC, the Code Commission forwarded Member comments to the experts for review.

• a) 

  Chapters 9.1., 9.2. and 9.3.

The Code Commission noted comments from the EU.

The Code Commission modified the text in point 3 of Articles 9.1.2. by adding the words ‘honey for human consumption’.

• b) 

  Small hive beetle infestation (Chapter 9.4.)

The Code Commission reviewed comments from Australia and the EU.

The Code Commission modified the text in point 2 of Article 9.4.2. by adding the words ‘honey for human consumption’.

• c) 

  Chapters 9.5. and 9.6.

The Code Commission reviewed comments from the EU.

The Code Commission modified the text in point 2 of Articles 9.5.2. and 9.6.2. by adding the words ‘honey for human consumption’.

The revised Chapters are provided at Annex XXII for Member comments.

Item 24. Avian influenza (Chapter 10.4.)

The Code Commission reviewed comments of Australia, the EU and the USA, and SCAD advice.

The Code Commission replaced the word ‘container’ by ‘packaging material’ in all articles relating to eggs (Articles 10.4.10, 11, 12, 13 and 14) as containers are defined in the Terrestrial Code and the definition is not appropriate to egg packaging material.

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The Code Commission discussed the comments of the EU and New Zealand on Article 10.4.6. regarding the testing of shipments of live birds other than poultry. The Code Commission considered that the final details of the sampling programme need to be agreed between trading partners and cannot be specified in the Terrestrial Code. However, in order to provide guidance to Members, the Code Commission modified Article 10.4.6. in line with advice from SCAD.

The Code Commission considered but did not accept the EU suggestion to change Articles 10.4.15. and 10.4.21. because these articles are consistent with the articles describing the procedures for the inactivation of AI viruses.

After considering the comments of the USA, the Code Commission decided to merge Articles 10.4.19. and 10.4.20. as the two articles deal with essentially the same risks and recommend the same approaches to risk management. The essential point is freedom of the country, zone or compartment from HPNAI – which applies equally when the country, zone or compartment is free from NAI.

The Code Commission noted recommendations of the USA on Articles 10.4.22. and 10.4.25. and added a reference to poultry meat meal in both articles and a third processing alternative at point 2 (c) of Article 10.4.25.

The revised Chapter is provided at Annex XXIII for Member comments.

Item 25. Newcastle disease (Chapter 10.13.)

The Code Commission reviewed comments from Australia, the EU and the USA.

The Code Commission replaced the word ‘container’ by ‘packaging material’ in all articles relating to eggs (Articles 10.13.8., 9. and 10.) as containers are defined in the Terrestrial Code and the definition is not appropriate to egg packaging material.

The Code Commission considered that the approach to management of risks of avian influenza in poultry meat meal should be applied to the management of risks associated with Newcastle disease virus and accordingly modified Article 10.13.16. and Article 10.13.19. by adding poultry meat meal to the scope of these articles, and added a third alternative to the processing parameters in Article 10.13.19.

The Code Commission noted the wide variation in the conclusions of studies on the inactivation of Newcastle disease viruses. However, based on the explanation provided by a Member and an expert, the Code Commission decided to remove ‘under study’ in Articles 10.13.20. and 10.13.21. and accepted the inclusion of poultry meat meal in Article 10.13.19. (feather meal and poultry meat meal).

The revised Chapter is provided at Annex XXIV for Member comments.

Item 26. Bovine brucellosis (Chapter 8.10.)

The Code Commission reviewed comments from the EU.

The Code Commission noted that an OIE ad hoc Group on Brucellosis will hold a meeting in November under SCAD to review the chapter and forwarded the submitted comments for consideration of experts.

Item 27. Bovine spongiform encephalopathy (Chapter 11.6.)

The Code Commission reviewed comments from Australia and the EU and comments submitted by an industry association.

In response to the EU comment, the Code Commission modified Articles 11.6.3. and 11.6.4. to clarify that providing the importation of cattle is done in accordance with Articles 11.6.7., 8. and 9., such importation would not change the status of the importing country.

In response to the comments from an industry association, Dr Thiermann recalled the decision of OIE Delegates at the 77^th OIE General Session. The Code Commission decided that the articles on gelatine should not be changed.

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In response to the EU comment on Article 11.6.14. and the request for the OIE to provide the scientific justification for considering only the distal ileum as specified risk material, the Code Commission noted that no new scientific information has come to light that would warrant changing the decisions based on the supporting document and reported in the Code Commission report of October 2006. The Commission welcomed the submission of relevant new scientific information.

In response to the comment of Australia on Article 11.6.15., Dr Thiermann clarified that the reason for the difference is that Article 11.6.14. applies to raw commodities whereas Article 11.6.15. refers to the production of gelatin, a very rigorous process that has been demonstrated in peer reviewed scientific studies to produce a safe commodity.

In response to the EU comment on Article 11.6.17., the Code Commission noted that the current text makes reference to Article 11.6.15., and thus limits the manufacturing of di-calcium phosphate (DCP) to vertebral columns from cattle under 30 months of age that have passed ante and post mortem inspection. Skulls are excluded. This recommendation is consistent with the current scientific knowledge on BSE and the safety of DCP produced in this manner has been verified by peer reviewed scientific study.

The Code Commission discussed the EU request to modify Article 11.6.20. but made no changes as it considered that the text was sufficiently clear.

In response to EU comments, the Code Commission added text on the assessment of the birth cohort of a case (Article 11.6.23.), to clarify the correct implementation of provisions on the feed ban.

The revised Chapter is provided at Annex XXV for Member comments.

Item 28. Tuberculosis of bovines and farmed cervidae

• a) 

  Bovine tuberculosis (Chapter 11.7.)

The Code Commission reviewed comments from Canada (the 77^th OIE General Session), the EU and South Africa.

The Code Commission accepted the EU proposal to modify the text of Article 11.7.2. for clarification of the meaning. However, the Code Commission did not accept the comment from South Africa regarding the inadequacy of abattoir monitoring for countries that have been free of bovine tuberculosis for at least five years. The Code Commission is not aware of any scientific evidence supporting this proposition. Moreover, the Code Commission is aware of this method being used with success by at least one OIE Member that has eradicated bovine tuberculosis.

The Code Commission accepted a proposal from the EU to modify Article 11.7.3. to clarify that all cattle in the compartment should be included in the certification.

In response to the comment of the Canadian Delegate regarding the consistency of the texts dealing with free compartments and free herds, the Code Commission confirmed that the requirements for a free compartment were intentionally stricter than those for free herds.

• b) 

  Bovine tuberculosis of farmed cervidae (Chapter 11.8.)

The Code Commission reviewed comments from the EU and accepted a recommendation to make Chapter 11.8 consistent with Chapter 11.7.

The revised Chapters are provided at Annex XXVI for Member comments.

Item 29. Contagious bovine pleuropneumonia (Chapter 11.9.)

The Code Commission reviewed comments from the EU and Kuwait.

The Code Commission discussed an EU comment calling for a definition of domestic cattle. However, rather than addressing this point in Chapter 11.9., the Commission noted that the OIE would have a broader discussion on the definition of the role of wildlife in the epidemiology of several diseases, including the

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implications for country status and trade. The EU comment should be considered in the context of this broader discussion.

In response to the comment of Kuwait, the Code Commission noted that the OIE ad hoc Group on Contagious Bovine Pleuropneumonia had recommended the removal of semen and embryos from the list of safe commodities and that bovine pleuropneumonia was not currently on any IETS list because insufficient scientific studies have been conducted for the IETS to evaluate the safety of embryos. Therefore, the Code Commission did not accept Kuwait’s recommendation.

The revised Chapters are provided at Annex XXVII for Member comments.

Item 30. Enzootic bovine leukosis (Chapter 11.11.)

The Code Commission reviewed comments from New Zealand.

The Code Commission proposed new text with the conditions for a free compartment, following a structure similar to that adopted in the chapter on bovine tuberculosis. The Code Commission also added text specifying which animals are considered to be susceptible to enzootic bovine leukosis, i.e. domestic cattle (Bos indicus and Bos taurus) and replaced the word ‘animal’ with ‘cattle’ as appropriate throughout the chapter.

The revised Chapter is provided at Annex XXVIII for Member comments.

Item 31. Infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (Chapter 11.13.)

The Code Commission reviewed comments from Australia and agreed with the proposal to make reference to testing according to the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals in Article 11.13.7.

The revised Chapter is provided at Annex XXIX for Member comments.

Item 32. Equine diseases (Chapters 12.1., 12.7. and 12.10.)

The Code Commission discussed with Dr Vallat the request of the People’s Republic of China (at the 77^th OIE General Session) for the OIE to consider establishing procedures for the official recognition of Member freedom from certain equine diseases. This matter will be considered by an ad hoc Group established under the SCAD. The Code Commission agreed to follow developments on this issue in collaboration with SCAD.

• a) 

  African horse sickness (Chapter 12.1.)

The Code Commission referred to the BSC a comment from Kenya regarding the use of vaccine for African horse sickness.

• b) 

  Equine influenza (Chapter 12.7.)

The Code Commission reviewed comments from Australia, and the advice of an expert, and modified the text of Article 12.7.6. as appropriate.

• c) 

  Equine viral arteritis (Chapter 12.10.)

The Code Commission reviewed comments from the EU, Kuwait and South Africa, and advice of three experts.

The Code Commission did not accept the recommendation of Kuwait on point 3 of Article 12.10.2., because the period described in this point could vary depending on the timing of the first test (‘not earlier than 7 days after commencing isolation’).

Based on Member comments and expert consultation, several changes were made.

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The revised Chapters 12.7. and 12.10. are provided at Annex XXX for Member comments.

Item 33. Scrapie (Chapter 14.9.)

The Code Commission reviewed comments of Canada, the EU and New Zealand, as well as comments made by the USA at the 77^th OIE General Session.

In response to the EU comment, the Code Commission modified Article 14.9.1. (General Provisions) to express more clearly the OIE’s position that scrapie does not present a risk to human health. In response to the comment of Canada on the safety of semen, the Code Commission included semen in Article 14.9.1. as a safe commodity. The justification for this decision was provided as follows:

Evidence from epidemiological studies and experimental matings of scrapie-affected rams suggests that scrapie is unlikely to be transmitted by semen (Wrathall 2000, Wang et al. 2001, Wrathall et al. 2008). Palmer (1959) failed to transmit scrapie by subcutaneous injection into lambs of semen from a clinically affected ram. The lambs were, however, only observed for 30 months post-inoculation and this observation period would now be considered less than ideal.

Bioassays in mice have failed to detect scrapie infectivity in testis, seminal vesicles and semen of affected rams (Hourrigan et al. 1979, Hourrigan 1990, Hadlow 1991, Hourrigan and Klingsporn 1996). Hourrigan reported the failure to detect infectivity in semen samples from 21 cases of scrapie (Hourrigan 1990). The study by Hadlow et al. (1980) showed that the distribution of scrapie infectivity in goats is essentially the same as in naturally-infected sheep.

Gatti and colleagues were unable to detect PrPsc in seminal plasma of rams with scrapie, suggesting that infectivity was absent (Gatti et al. 2002). The conclusions of this study have recently been confirmed by an experiment in which semen from infected rams was inoculated into scrapie-susceptible transgenic mice expressing the VRQ allele of the sheep prion gene (Sarradin et al. 2008).

The transgenic mouse model used by Sarradin and colleagues (2008) has been shown to be capable of detecting very low levels of infectivity. The study reported by Sarradin and others (2008) demonstrated that scrapie was not transmitted by semen at any time during the incubation period of scrapie in four rams, even from one of the highly susceptible VRQ/VRQ genotype during the clinical stages of the disease.

In reply to the EU question on the justification for the seven-year period stated in Article 14.9.3., the Code Commission pointed out that this recommendation came from the ad hoc Group on Scrapie and had been based on twice the average time period for the scrapie agent to be transmitted from one generation of sheep to the next.

The Code Commission did not agree with the Canadian request to permit the introduction of rams and bucks from establishments other than free establishments, although it had been permitted in the 2008 edition of the Terrestrial Code. There may be a small risk that rams and bucks, if infected with scrapie, could transmit scrapie via saliva and faeces.

Noting the supportive advice of SCAD on the topic of historical freedom, the Code Commission did not accept the EU proposal to adopt numerical testing targets to establish freedom because to prove the absence of a disease of this nature would require testing of a very large number of animals. The concept of historical freedom has been accepted by the OIE and is appropriate in the case of scrapie. However, the Code Commission modified Article 14.9.15. to strengthen the provisions for the formal programme of targeted surveillance. The Code Commission also deleted from Articles 14.9.14. and 14.9.15. references to demonstrating the presence of susceptible genotypes in the population of sheep in the country because, since the chapter was drafted, there had been significant advances in knowledge on the genetics of scrapie susceptibility and it is highly unlikely that any country would have a small ruminant population without susceptible genotypes.

The EU comment on point 2 a) and b) of Article 14.9.3. was not accepted as the requirement for scrapie to be notifiable is already covered in Article 14.9.3. (point 1).

The Code Commission did not accept the recommendation of the USA (the 77^th OIE General Session) to target surveillance for scrapie to all cull sheep rather than to sheep with chronic wasting conditions.

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However, the text in point 2 (b) of Article 14.9.3. was modified to provide that mature sheep found dead on farm should be tested when the numbers of mature culled sheep and goats over 18 months of age were insufficient in the practical situation. In addition, the words ‘under study’ were removed from this point.

In regard to compartments, the Code Commission considered that there is likely to be commercial interest in this approach and the provisions of Article 14.9.4. should be as clear as possible. With this objective, the Code Commission modified the chapeau and several points in this article.

The Code Commission noted the support of SCAD for the EU comment on Article 14.9.6. and agreed to delete the option for placing imported animals in a quarantine station, given that the OIE is unable to provide specific recommendations on the testing and associated parameters.

The Code Commission did not agree to combine Articles 14.9.11. and 14.9.12. as recommended by SCAD; however, it modified the text of Article 14.9.12. to indicate that listed products should not be traded internationally, consistent with the EU comment.

The revised Chapter is provided at Annex XXXI for Member comments.

Item 34. Classical swine fever (Chapter 15.3.)

The Code Commission reviewed comments received from Australia and South Africa, comments made by the Delegate of the USA at the 77^th OIE General Session, and advice of the SCAD.

The Code Commission noted that South Africa’s comment on Article 15.3.2. had already been addressed. As stated at the 77^th OIE General Session, the criterion in point 7 of Article 15.3.2. applies to the determination of status and the text does not need to be repeated in other articles.

The Code Commission accepted the comment of the USA on Article 15.3.3. and made an appropriate modification to the text. The comments of Australia on Article 15.3.22. (procedures for the inactivation of CSF virus in trophies) were referred to the SCAD for advice on the scientific issues raised.

The SCAD confirmed that the articles dealing with surveillance for classical swine fever would be reviewed to ensure consistency with the articles on disease surveillance in Chapter 10.4. (Avian Influenza) and Chapter 10.13. (Newcastle Disease) by the ad hoc Group on Epidemiology.

The revised Chapter is provided at Annex XXXII for Member comments.

Item 35. Swine vesicular disease (Chapter 15.5.)

The Code Commission received extensive comments from the EU, Korea (Rep. of), New Zealand and Thailand.

The Code Commission acknowledged Members’ requests for advice on surveillance and inactivation procedures for swine vesicular disease virus in swine products, similar to the approach taken in Chapter 15.3. (Classical Swine Fever). The Code Commission is awaiting advice from the SCAD, which will convene an ad hoc Group to provide advice on these points. Once the content of the chapter has been agreed, the International Trade Department will align the format of the chapter with that of Chapter 15.3. In the interim, the Code Commission made no changes to Chapter 15.5.

Item 36. Teschovirus encephalomyelitis (Chapter 15.6.)

The Code Commission received comments from the EU.

With agreement of the Director General and the SCAD and noting that this disease is no longer listed by the OIE, the Code Commission proposed to delete the chapter and all references to this disease in the Terrestrial Code.

The deleted Chapters is provided at Annex XXXIII for Member comments.

C. OTHER ISSUES

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Item 37. Private standards for sanitary measures and animal welfare

Dr Sarah Kahn briefed the Code Commission on the current OIE work programme on private standards. The OIE has sent a questionnaire to Members and the replies to the questionnaire will be reviewed by the ad hoc Group on Private Standards, which will hold a meeting on 9-10 November 2009.

Dr Kahn indicated that Dr Vallat had attended the General Assembly of the Codex Alimentarius Commission (CAC) and had made a presentation on, inter alia, private standards. A recording of Dr Vallat’s presentation may be found on the CAC website at:

http://www.codexaudio.net/CAC_32/OriginalVersion/Index_en.html (see file at Thursday Part 1, Dr Vallat starts speaking at 7 minutes into the recording).

The ad hoc Group has been asked to propose an OIE strategy to help Members to avoid trade problems arising from private standards on sanitary measures and on animal welfare.

The Code Commission noted this update and agreed that it would consider the report of the ad hoc Group at the Commission’s February 2010 meeting.

The report of the ad hoc Group is provided at Annex XL or information of Members.

Item 38. Trade in animal products (‘commodities’)

Dr Keith Hamilton (OIE Scientific and Technical Department) briefed the Code Commission on the literature review that has been prepared for the ad hoc Group on Trade in Animal Products (“Commodities”), which will hold its next meeting on 15 October 2009.

In the context of its work on safe commodities and to be consistent with the modification of several chapters to highlight the safe commodities, the Code Commission proposed modifications to the chapters on Rift Valley fever and Aujeszky’s disease.

The Code Commission noted the update provided by Dr Hamilton and undertook to continue working on this issue as a matter of priority at its February 2010 meeting.

The revised Chapters are provided at Annex XXXIV for Member comments.

Item 39. Wildlife disease reporting – update on developments with WAHIS

The Code Commission received comments from South Africa.

Dr Francesco Berlingieri briefed the Code Commission on the development of WAHIS – Wild, which is a supplement to the existing OIE programme for reporting animal diseases. The Code Commission discussed the implications of this redevelopment and agreed that the topic of wildlife diseases and implications for trade should remain as an important issue on the future work programme of the OIE and of the Code Commission.

Item 40. Future work programme of the Code Commission

The Code Commission updated its work programme for 2009–2010, which may be found at Annex XLIV.

Item 41. Other issues

The next meeting of the Code Commission is scheduled for 8–12 February 2010. The deadline for comments to be considered by the Code Commission at this meeting is 8 January 2010.

.../Annexes

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Annex I

MEETING OF THE OIE TERRESTRIAL ANIMAL HEALTH STANDARDS COMMISSION

Paris, 7–18 September 2009

List of participants

MEMBERS OF THE CODE COMMISSION

Dr A. Thiermann

(President)

US Mission to the OECD

19, rue de Franqueville

75016 Paris

FRANCE

Tel.: 33-(0)1 44 15 18 69

E-mail: a.thiermann@oie.int

Dr E. Bonbon

(Vice-President)

Commission européenne

DG SANCO-D1

Rue Froissart 101

1040 Bruxelles

Belgique

Tel: 32-2-2985845

Fax: 32-2-2953144

E-mail:

etienne.bonbon@ec.europa.eu

Dr J. Caetano

(Secretary General)

Director of Animal Programme

Secretaria de Defesa Agropecuaria

Ministerio da Agricultura, Pecuaria e

Abastecimento

Espl. dos Ministerios

Bloco D Anexo B4 -ANDAR

70.043-900 Brasilia DF

BRAZIL

Tel.: (55-61) 321.823.14/321.823.15

E-mail jcaetano@agricultura.gov.br

Dr S.K. Hargreaves

Principal Director of Livestock

and Veterinary Services

Ministry of Agriculture

PO Box CY66

Causeway Harare

ZIMBABWE

Tel.: (263-4) 791.355/722.358

Fax: (263-4) 791.516

E-mail: skhargreaves@zol.co.zw

OTHER PARTICIPANTS

Prof. A.M. Hassan                               Prof. S.C. MacDiarmid

Veterinary Expert                                  Principal International Adviser

Federal Ministry of Animal Resources Risk Analysis, International Coordination and AdAdjunct Pr

and Fisheries                                        Adjunct Professor in Veterinary Biosecurity

Khartoum                                              (Massey University)

SUDAN                                                 Biosecurity New Zealand

Tel.: (249) 912.163.979                        P.O. Box 2526

Fax: (249) 834.75 996                          Wellington

E-mail: ahmedhassan32@hotmail.comNEW ZEALAND

hescobusiness@yahoo.com                Tel.: (64-4) 894.0420

Fax: (64-4) 894.0731

E-mail:

Stuart.MacDiarmid@maf.govt.nz

Prof. Michel Thibier

Professeur Michel THIBIER

Conseil Général de de l'Agriculture de l'Alimentation et des Espaces

Ruraux

Ministère de l'Alimentation, de l'Agriculture et de la Pêche

251 rue de Vaugirard

75732 Paris Cedex 15

FRANCE

Tel: +33 (0)1 49 55 84 33

Fax :+33 (0)1 49 55 81 69

michel.thibier@agriculture.gouv.fr

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Annex I (contd)

OIE HEADQUARTERS

Dr B. Vallat

Director General

12, rue de Prony

75017 Paris

FRANCE

Tel.: 33 (0)1 44 15 18 88

Fax: 33 (0)1 42 67 09 87

E-mail: oie@oie.int

Dr W. Pelgrim

Chargé de mission

OIE

Tel.: 33 (0)1 44 15 18 68

E-mail: w.pelwrim@oie.int

Dr Sarah Kahn

Head

International Trade Department

OIE

Tel.: 33 (0)1 44.15.18.80

E-mail: s.kahn@oie.int

Dr L. Stuardo

Chargé de mission

International Trade Department

OIE

Tel.: 33 (0)1 44 15 18 72

E-mail: l.stuardo@oie.int

Dr Y. Atagi

Deputy Head

International Trade Department

OIE

Tel.: 33 (0)1 44.15.18.92

E-mail: y.atagi@oie.int

Dr Gillian Mylrea

Chargée de mission

International Trade Department

OIE

Tel.: 33 (0)1 44.15.18.67

E-mail: g.mylrea@oie.int

Annex II

MEETING OF THE OIE TERRESTRIAL ANIMAL HEALTH STANDARDS COMMISSION

Paris, 7–18 September 2009

Adopted agenda

1.

Welcome - Director General

A. MEETING WITH THE DIRECTOR GENERAL

B. JOINT MEETING OF THE CODE COMMISSION AND THE SCIENTIFIC

COMMISSION

• 1. 

  Interface of wildlife and livestock how to incorporate the relevant wildlife aspects

into disease-specific chapters

2.

Joint discussion on specific chapters

• a) 

  Animal health surveillance

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• b) 

  Foot and mouth disease
• c) 

  Swine vesicular disease
• d) 

  Avian influenza and Newcastle disease
• e) 

  Classical swine fever
• f) 

  Other issues

C. EXAMINATION OF MEMBER COMMENTS AND WORK OF RELEVANT EXPERT

GROUPS

• 1. 

  Update on reports of other commissions and other relevant activities of the OIE -President of the Commission
• 2. 

  Code revision Item 1   Glossary

Item 2   Animal health surveillance (Chapter 1.4.)

Item 3   Surveillance of arthropod vectors of animal disease (Chapter 1.5.)

Item 4   Status for OIE listed diseases (Chapter 1.6.)

Item 5   Import risk analysis (Chapter 2.1. and report of the ad hoc Group)

Item 6   Evaluation of veterinary services (Chapters 3.1. and 3.2.)

• a) 

  Draft revisions to Chapter 3.1. and 3.2.
• b) 

  Guidelines on veterinary legislation
• c) 

  PVS Feed back session in December 2009

Item 7 Design and implementation of animal systems to achieve animal traceability (Chapter 4.2.)

Item 8 Zoning and compartmentalisation

• a) 

  Zoning and compartmentalisation (Chapter 4.3.)

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• b) 

  Application of compartmentalisation (Chapter 4.4.)

Item 9 Semen and embryo chapters (Chapters 4.5.- 8., 10.)

Item 10 General obligations related to certification (Chapter 5.1.)

Item 11 Control of hazards of animal health and public health importance in animal feed (Chapter 6.3.)

Item 12 Control of hazards of animal health and public health importance in heat treated pet food (new draft Chapter)

Item 13 Salmonellosis

• a) 

  Report on the Codex Working Group meeting (Brazil 7-12 September 2009)
• b) 

  Biosecurity procedures in poultry production (revised Chapter 6.4.)
• c) 

  Prevention, detection and control of Salmonella in poultry (Chapter 6.5.) and Salmonella enteritidis and Salmonella typhimurium in poultry (Chapter 6.6.).

Item 14 Introduction to the recommendations for controlling antimicrobial resistance (Chapter 6.7.)

Item 15 Animal welfare

• a) 

  Use of animals in research and education (new draft chapter) and report of the third meeting of the OIE ad hoc Group on Laboratory Animal Welfare (including OIE discussion paper on air transport of laboratory animals).
• b) 

  Animal welfare definition (Chapter 7.1.)
• c) 

  Stray dog population control (Chapter 7.7.)
• d) 

  Report of the eighth meeting of the OIE Animal Welfare Working Group
• e) 

  Report of the OIE Electronic Consultation Group on Poultry Welfare
• f) 

  Report of the first meeting of the OIE ad hoc Group on Animal Welfare and Broiler Chicken Production Systems

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• g) 

  Report of the first meeting of the OIE ad hoc Group on Animal Welfare and Beef Cattle Production Systems.

Item 16 Other horizontal chapters

• a) 

  Animal health measures applicable before and at departure (Chapter 5.4.)
• b) 

  Border posts and quarantine stations in the importing country (Chapter 5.6.) Item 17 Anthrax (Chapter 8.1.)

Item 18 Bluetongue (Chapter 8.3.)

Item 19 Foot and mouth disease (Chapter 8.5.)

Item 20 Paratuberculosis (Chapter 8.9.)

Item 21 Rabies (Chapter 8.10.)

Item 22 West Nile fever (Chapter 8.16.)

Item 23 Diseases of bees (Chapters 9.1. -6.)

Item 24 Avian influenza (Chapter 10.4.)

Item 25 Newcastle disease (Chapter 10.13.)

Item 26 Bovine brucellosis (Chapter 11.3.)

Item 27 Bovine spongiform encephalopathy (Chapter 11.6.)

Item 28 Bovine tuberculosis (Chapter 11.7.) and Bovine tuberculosis of farmed cervidae (Chapter 11.8.)

Item 29 Contagious bovine pleuropneumonia (Chapter 11.9.)

Item 30 Enzootic bovine leukosis (Chapter 11.11.)

Item 31 Infectious bovine rhinotracheitis/ infectious pustular vulvovaginitis (Chapter 11.13.)

Item 32 Equine diseases

• a) 

  African horse sickness (Chapter 12.1. inactivated vaccine from GS77)
• b) 

  Equine influenza (Chapter 12.7.)

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• c) 

  Equine viral arteritis (Chapter 12.10.)

Item 33 Scrapie (Chapter 14.9., semen/embryo issue with IETS, historical freedom)

Item 34 Classical swine fever (Chapter 15.3.)

Item 35 Swine vesicular disease (Chapter 15.5.)

Item 36 Teschovirus encephalomyelitis (Chapter 15.6.)

C. Other issues

Item 37 Private standards for sanitary measures and animal welfare – update.

Item 38 Trade in Animal Products (“commodities”) – status report.

Item 39 Wildlife disease reporting: update on developments with WAHIS

Item 40 Future work programme of the Code Commission

Item 41 Other issues

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Annex III GLOSSARY

EU Comments

The EU can support the proposed changes but has a comment in relation to Quarantine station.

For the purposes of the Terrestrial Code :

Central Bure auHeadquarte rs

means the Permanent Secretariat of the World Organisation for Animal Health which headquarters are located at:

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: oie@ oie.int WWW: http://www.oie.int

E arly detection syste m

means a system for the timely detection and identification of an incursion or emergence of diseases /infections in a country, zone or compartment . An early detection system should be under the control of the V eterinary Services and should include the following characteristics:

• a. 

  representative coverage of target animal populations by field services;
• b. 

  ability to undertake effective disease investigation and reporting;
• c. 

  access to laboratories capable of diagnosing and differentiating relevant diseases ;
• d. 

  a training programme for veterinarians , veterinary para-professionals , livestock owners/keepers and others involved in handling animals for detecting and reporting unusual animal health incidents;
• e. 

  the legal obligation of private veterinarians to report to the V eterinary A uthority ;
• f. 

  a national chain command.

Qu aran tin e station

means a premises an establishment under the control of the V eterinary A uthority where animals are maintained in isolation with no direct or indirect contact with other animals , to prevent ensure that there is no the transmission of specified pathogen(s) outside the establishment while the animals are undergoing observation for a specified length of time and, if appropriate, testing and treatment. The presence of disease or infection in animals in the quarantine station does not affect the animal health status of the country or zone .

EU comment

The word "outside" in the third line should be changed to "into or out of".

In addition, the proposed new sentence added to the definition is not really part of the definition and relates to imports and therefore implies that this definition of quarantine station is only for imports. As there are other reasons such as export or diagnosis of disease or vaccine virus challenge this could be included in the relevant Chapter 5.6. concerning imports.

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Moreover, this assumption is only valid if the prescriptions of the definition are fulfilled (isolation), thus it should be stated too.

Finally, does this definition also have a consequence on quarantine as part of Artificial Insemination centres?

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.

V ariab ility

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.

text deleted

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Annex III (contd) PROPOSED CHAPTER ON COMMUNICATION

EU Comments

The EU has several comments on this proposed chapter, inserted below.

The adoption of this chapter, which is merely at the first draft stage, will need a full cycle of comments, thus not being possible before May 2011.

General considerations

Introduction

There is a need to institutionalize communication as a discipline within Veterinary Services in order for them to achieve effective internal and external communication. Communication underpins everything that Veterinary Services do including prevention, surveillance, animal welfare, disease response, public health and food safety. The integration/combination of veterinary and communication expertise is essential for effective communication.

Principles

• • 

  Communication is a continuous process
• • 

  Veterinary Services should be mandated and have the authority to communicate
• • 

  Veterinary Services are responsible to plan, implement, monitor, evaluate and revise communication

EU Comments

The VS communicate on animal health and welfare and/or veterinary public health issues. This should be indicated in the two sentences above, by adding the words "on matters on which they have authority".

Moreover, it should be the Veterinary Authority that is responsible for communication. Veterinary Authority should replace Veterinary Services.

• • 

  Importance of joint technical veterinary expertise and professional communication skills when intending to disseminate scientific information
• • 

  Suitable criteria for communication

▫     Transparency

▫     Consistency

▫     Timeliness

▫     Balance

▫     Accuracy

▫     Honesty

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• - 

  Targeted Definitions

Communication

means the discipline of informing, influencing, and motivating individual, institutional and public audiences, preferably on the basis of interactive exchanges, about any issue falling under the mandate of the OIE and the competence of the Veterinary Services.

EU Comments

The word "influencing" is not relevant as the Communication in the intended scope of this chapter is a technical tool to get actions done.

The words "provoking action/reaction from" should be used instead.

Crisis

means a time of great danger, difficulty or uncertainty when problems related to any issue falling under the mandate of the OIE and the competence of the V eterinary Services require immediate action.

EU Comments

This definition is very difficult to understand. A crisis is not a "time" but rather a "situation"; moreover, introducing the notion of "danger" in the definition of crisis makes it very subjective.

Proposed wording:

"means a local, regional or global situation where issues that fall under the mandate of the OIE and the competence of the Veterinary Services are at stake and where economy or public health may be greatly affected, depending of the actions engaged."

Crisis Communic ation

means the process of providing information of potentially incomplete nature within time constraints that allows an individual, affected and/or interested parties, an entire community or the general public to make best possible decisions and be informed of and/or accept policy decisions and rationale behind policy decisions during a crisis.

EU Comments

This definition is very difficult to understand. It should be more simple and straightforward, and use the fact that communication has a definition already.

Proposed wording:

"means a type of communication destined to provide, within the constraints of a crisis, the most accurate and targeted information to an individual, affected and/or interested parties, an entire community or the general public, in order to get the best reactions in view of the managing of the crisis."

Outb re ak c ommunic ation

means the process of communicating in the event of an outbreak . Outbreak communication includes notification .

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Required elements

• • 

  Proper organizational structure within VS

▫ VS should be mandated and have the authority to communicate

▫ Dedicated communication unit

▫ Official contact points

▫ Clearly defined chain of command (governance)

• • 

  Human resources

▫ Qualified personnel

▫ Training

▫ Adequate number (back-up)

▫ Job descriptions

• • 

  Financial and material resources ▫ Budget

▫ Equipment

▪ Office equipment

▪ Technical equipment

▪ Access to the Internet ▫ Suitable premise/accommodation

• • 

  Documentation for demonstration (evidence to demonstrate capabilities) ▫ Policies on communication

▫ Work plans

▫ Communication products

• • 

  Quality assessment and evaluation ▫ Monitoring system in place
• • 

  Consequences For the society

▫ Increased knowledge and awareness ▫ Acceptance of policy decisions

▫ Consequential change of perception, attitude and/or behaviour For VS ▫ Raising the profile/awareness/knowledge

▫ Improve trust/credibility

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Annex IV

CH AP TE R 1.4. ANIMAL HEALTH SURVEILLANCE

EU Comments

The EU can support the proposed changes.

Article 1.4.1. Introduction and objectives

• 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 recommendations may be applied to all diseases , their agents and all susceptible species (including wildlife) 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 recommendations in this chapter 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 recommendations in this chapter.
• 2. 

  Animal health surveillance is an essential tool to detect disease or infection , to monitor disease trends, to facilitate the control of disease or infection , to support claims for freedom from disease or infection , to provide data for use in risk analysis , for animal and/or public health purposes, and to substantiate the rationale for sanitary measures. Both domestic and wild animals are susceptible to certain disease /infection . However, in the presence of appropriate biosecurity measures, disease /infection in wild animals does not imply mean that the same disease /infection is necessarily present in domestic a nimals in the same country or z one . Surveilla nce data underpin the quality of disease status reports and should satisfy information requirements of risk analysis for international trade and for national decision-making. Wildlife may be included because they can serve as reservoirs and as indicators of human and domestic animal and wildlife disease . Wildlife disease /infection surveillance presents specific challenges that may differ significantly from surveillance in livestock.
• 3. 

  Prerequisites to enable an OIE Member to provide information for the evaluation of its animal health status are:
• a. 

  that the Member complies with the provisions of Chapter 3.1. of the Terrestrial Code ;
• 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. of the Terrestrial Code .
• 4. 

  The objectives of this chapter are to:
• a. 

  provide guidance to the type of outputs that a surveillance system should generate;
• b. 

  provide recommendations to assess the quality of disease /infection surveillance systems.

Article 1.4.2.

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Definitions

The following definitions apply for the purposes of this chapter:

Bias: means a tendency of an estimate to deviate in one direction from a true value.

Case definition: means a set of criteria used to classify an animal as a case .

Confidence: in the context of demonstrating freedom from infection , confidence is the probability that the type of surveillance applied would detect the presence of infection if the population were infected. The confidence depends on, among other parameters, the assumed level of infection in an infected population. The term refers to confidence in the ability of the surveillance applied to detect disease /infection , and is equivalent to the sensitivity of the surveillance system.

Probability sampling: means a sampling strategy in which every unit has a known non-zero probability of inclusion in the sample.

Sample: means the group of elements (sampling units) drawn from a population, on which tests are performed or parameters measured to provide surveillance information.

Sampling units: means the unit that is sampled, either in a random survey or in non-random surveillance . This may be an individual animal or a group of animals (e.g. an epidemiological unit ). Together, they comprise the sampling frame.

Sensitivity: means the proportion of truly positive units that are correctly identified as positive by a test.

Specificity: means the proportion of truly negative units that are correctly identified as negative by a test.

Study population: means the population from which surveillance data are derived. This may be the same as the target population or a subset of it.

Surveillance system: means a method of surveillance that may involve one or more component activities that generates information on the health, disease or zoonosis status of animal populations.

Survey: means an investigation in which information is systematically collected, usually carried out on a sample of a defined population group, within a defined time period.

Target population: means the population about which conclusions are to be inferred.

Test: means a procedure used to classify a unit as either positive, negative or suspect with respect to a disease or an i nf ecti on .

Test system: means a combination of multiple tests and rules of interpretation which are used for the same purpose as a test.

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Article 1.4.3. 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 chapter, surveillance activities are classified as being based on: EITHER i. structured population-based surveys, such as:
• - 

  systematic sampling at slaughter ;
• - 

  random surveys;
• - 

  surveys for infection in clinically normal animals , including wildlife; 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;
• - 

  wildlife disease data.

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• c. 

  In addition, surveillance data should be supported by related information, such as:
• i. 

  data on the epidemiology of the disease /infection , including environmental, host population distribution, and climatic information;
• ii. 

  data on animal movements, including transhumance, as well as natural wildlife migrations;
• iii. 

  trading patterns for animals and animal products;
• iv. 

  national animal health regulations, including information on compliance with them and their effectiveness;
• v. 

  history of imports of potentially infected material; and
• vi. 

  biosecurity measures in place;
• vii. 

  the risk likelihood and consequence of disease /infection introduction.
• 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 V eterinary Services (Chapter 3.1.).

• 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. 

  Time frame (or temporal values of surveillance data)

Surveillance should be carried out at a frequency that reflects the biology of the infection and the risk s of its introduction.

• c. 

  Epidemiological unit

The relevant epidemiological unit (s) for the surveillance system should be defined to ensure that it is representative of the population appropriate to meet the objectives of surveillance. 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.

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• d. 

  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 .

• e. 

  Case definition

A clear case definition should be defined developed for each disease /infection under surveillance , using clear criteria and, where they exist, the standards in the T errestrial Code . For wildlife disease /infection surveillance , it is essential to correctly identify and report host animal taxonomy (including genus and species).

EU comment

Replace the word "defined" by "specified".

• f. 

  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 host species, pathogens, varying production and surveilla nce systems, and types and amounts of data and information available.

The methodology used should be based on the best information available. It should also be in accordance with this chapter, 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.

• g. 

  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 surveilla nce data.

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The values of sensitivity and specificity for the tests used should be specified for each species in which they may be used, 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.

• h. 

  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.

• i. 

  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.

• j. 

  Data collection and management

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; this requires effective collaboration among all stakeholders, such as government ministries, non-governmental organisations, and others, particularly for data involving wildlife;
• - 

  the ability of the data processing system to detect missing, inconsistent or inaccurate data, and to address these problems;
• - 

  maintenance of disaggregated data rather than the compilation of summary data;
• - 

  minimisation of transcription errors during data processing and communication.

Article 1.4.4.

Structured population-based surveys

In addition to the principles for surveillance discussed above, the following recommendations 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 t wo following ways:

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• 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.

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 and degree of understanding of the population being studied, the epidemiology of the infection and the resources available.

Data on wild animal population size often do not exist and should be determined before a survey can be designed. The expertise of wildlife biologists may be sought in the gathering and interpretation of such population data. Historical population data should be updated since these may not reflect current populations.

• 3. 

  Sampling

The objective of sampling from a population is to select a subset of units that is representative of the population of interest with respect to the objective of the study. Sampling should provide the best likelihood that the sample will be representative of the population, within the practical constraints imposed by different environments and production systems.

Specimens from wildlife for surveillance may be available from sources such as hunters and trappers, road-kills, wild animal meat markets, sanitary inspection of hunted animals , morbidity-mortality observations by the general public, wildlife rehabilitation centres, wildlife biologists and wildlife agency field personnel, farmers, and other landholders, naturalists and conservationists. Wildlife data such as census data, trends over time, and reproductive success can be used in a manner similar to farm production records for epidemiological purposes.

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• 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.

• 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 1.4.5. Structured non-random surveillance

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).

• 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).

Whenever the responsibility for disease notification falls outside the scope of the V eterinary A uthority , for example in some countries for diseases in wildlife, effective communication and data sharing should be established with the relevant authorities to ensure comprehensive and timely disease reporting.

• 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 .

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• 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 slaughterhouses may provide valuable surveillance data. The sensitivity and specificity of slaughterhouse inspection for detecting the presence of specified diseases under the inspection system in place should be pre-determined. The accuracy of the inspection system will be influenced by:

• i. 

  the training, experience and number of the inspection staff;
• ii. 

  the involvement of the Competent A uthorities in the supervision of ante-mortem and post-mortem inspections;
• iii. 

  the quality of construction of the slaughterhouse , speed of the slaughter chain, lighting quality, etc.; and
• iv. 

  staff morale and motivation for efficient performance.

Slaughterhouse inspections are likely to provide good coverage for particular age groups and geographical areas only. Slaughterhouse surveillance data are subject to biases in relation to target populations (e.g. only animals of a particular class and age are likely to be slaughtered for human consumption in significant numbers). Such biases need to be recognised when analysing surveillance data.

For traceback and analysis of spatial and herd -level coverage, there should be, if possible, an effective identification system that relates animals in the slaughterhouse to their 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.

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• 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 /infection (usually serologically). They are particularly useful for surveillance of for diseases /infections with a strong spatial component, such as vector -borne diseases /infections . 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 /infection .

• 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 standardised case definition is applied. E ducation 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 /infection 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.

• j. 

  Wildlife data

Specimens from wild animals for disease /infection surveilla nce may be available from sources such as hunters and trappers, road-kills, wild animal meat markets, sanitary inspection of hunted animals , morbidity and mortality observations by the general public, wildlife rehabilitation centres, wildlife biologists and wildlife agency field personnel, farmers and other landholders, naturalists and conservationists. Wildlife data such as census data, trends over time, and reproductive success can be used in a manner similar to farm production records for epidemiological purposes.

• 2. 

  Critical elements for structured non-random surveillance

There are 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 sources can, however, be a cost-efficient method of early detection, and may increase the level of confidence or detect a lower level of prevalence compared to random sampling surveys.

• 3. 

  Analytical methodologies

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.

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• 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 a shorter period of time.

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 1.4.6.

Surveillance to demonstrate freedom from disease/ infection

• 1. 

  Requirements to declare a country, zone or compartment free from disease/infection without pathogen specific surveillance

This Article provides general principles for declaring a country, zone or compartment free from disease /infection in relation to the time of last occurrence and in particular for the recognition of historical freedom.

The provisions of this Article are based on the principles described in Article 1.4.3. of this chapter and the following premises:

• - 

  in the absence of disease and vaccination, the animal population would become susceptible over a period of time;
• - 

  the disease agents to which these provisions apply are likely to produce identifiable clinical signs in susceptible animals ;
• - 

  competent and effective V eterinary Services will be able to investigate, diagnose and report disease, if present;
• - 

  disease /infection can affect both wild and domestic animals ;
• - 

  the absence of disease /infection over a long period of time in a susceptible population can be substantiated by effective disease investigation and reporting by a Member.
• a. 

  Historically free

Unless otherwise specified in the relevant disease chapter, a country, zone or compartment may be recognised free from infection without formally applying a pathogen-specific surveilla nce programme when:

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• i. 

  there has never been occurrence of disease , or
• ii. 

  eradication has been achieved or the disease /infection has ceased to occur for at least 25 years, provided that for at least the past 10 years:
• iii. 

  it has been a notifiable disease ;
• iv. 

  an early detection system has been in place for all relevant species;
• v. 

  measures to prevent disease /infection introduction have been in place; no vaccination against the disease has been carried out unless otherwise provided in the Terrestrial Code ;
• vi. 

  infection is not known to be established in wildlife within the country or zone intended to be declared free. A country or zone cannot apply for historical freedom if there is any evidence of infection in wildlife.
• b. 

  Last occurrence within the previous 25 years

Countries, zones or compartments that have achieved eradication (or in which the disease /infection has ceased to occur) within the previous 25 years, should follow the pathogen-specific surveillance requirements in the Terrestrial Code if they exist. In the absence of specific requirements for surveillance in the Terrestrial Code , countries should follow the general recommendations on surveillance to demonstrate animal health status outlined in this chapter provided that for at least the past 10 years:

• i. 

  it has been a notifiable disease ;
• ii. 

  an early detection system has been in place;
• iii. 

  measures to prevent disease /infection introduction have been in place;
• iv. 

  no vaccination against the disease has been carried out unless otherwise provided in the Terrestrial Code ;
• v. 

  infection is not known to be established in wildlife within the country or zone intended to be declared free. A country or zone cannot apply for freedom if there is any evidence of infection in wildlife.
• 2. 

  Recommendations for the discontinuation of pathogen-specific screening after recognition of freedom from infection

A country, zone or compartment that has been recognised as free from infection following the provisions of the Terrestrial Code may discontinue pathogen-specific screening while maintaining the infection-free status provided that:

• a. 

  it is a notifiable disease ;
• b. 

  an early detection system is in place;
• c. 

  measures to prevent disease /infection introduction are in place;

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• d. 

  vaccination against the disease is not applied;
• e. 

  infection is known not to be established in wildlife. It can be difficult to collect sufficient epidemiological data to prove absence of disease /infection in wild animal populations. In such circumstances, a range of supporting evidence should be used to make this assessment.
• 3. 

  Self declaration of disease/infection

Members may make a self declaration that a country, zone or compartment is free from a listed disease , based on the implementation of the provisions of the Terrestrial Code and the Terrestrial Manual - see relevant provisions in Chapter 1.5. The V eterinary A uthority may wish to transmit this information to the OIE Central Bureau , which may publish the information.

• 4. 

  International recognition of disease/infection free status

For diseases for which procedures exist whereby the OIE can officially recognise the existence of a disease /infection free country, zone or compartment , a Member wishing to apply for recognition of this status shall, via its Permanent Delegate, send to the OIE all the relevant documentation relating to the country, zone or compartment concerned. Such documentation should be presented according to the recommendations prescribed by the OIE for the appropriate animal diseases .

• 5. 

  Demonstration of freedom from infection

A surveillance system to demonstrate freedom from infection should meet the following requirements in addition to the general requirements for surveillance outlined in Article 1.4.3. of this chapter.

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 Members) 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. The implications of disease /infection in wildlife for the status of domestic animals in the same country or zone should be assessed in each situation, as indicated in the relevant chapter on each disease in the Terrestrial Code .

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 1.4.7.

Surveillance for distribution and occurrence of infection

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.

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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:

• 1. 

  prevalence or incidence of infection ;
• 2. 

  morbidity and mortality rates;
• 3. 

  frequency of disease /infection risk factors and their quantification;
• 4. 

  frequency distribution of herd sizes or the sizes of other epidemiological units ;
• 5. 

  frequency distribution of antibody titres;
• 6. 

  proportion of immunised animals after a vaccination campaign;
• 7. 

  frequency distribution of the number of days elapsing between suspicion of infection and laboratory confirmation of the diagnosis and/or to the adoption of control measures;
• 8. 

  farm production records;
• 9. 

  role of wildlife in maintenance or transmission of the infection .

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Annex V

CH AP TE R 1.5.

SURVEILLANCE OF ARTHROPOD VECTORS OF ANIMAL DISEASES

EU Comments

The EU can support the proposed changes.

Article 1.5.1. Introduction

V ector -borne diseases are of increasing importance economically and to human and animal health.

Environmental (including climate change), sociological and economical changes may affect the distribution and impact of these diseases .

Improved understanding of the distribution and population dynamics of the vectors is a key element for assessing and managing the risk s associated with vector -borne animal and zoonotic disea ses .

The Terrestrial Code contains recommendations for the surveillance of several vector -borne diseases and general recommendations for animal health surveillance .

The need has arisen to complement these general recommendations on surveillance with additional advice on the surveillance of vectors themselves. This chapter only addresses surveilla nce for arthropod vectors .

For the purpose of trade, it must be noted that there is no conclusive relationship between the presence of a vector(s) and the disease status of a country/zone , and also that the apparent absence of a vector(s) does not by itself confirm vector -free status.

A decision tree for vector surveillance is presented in Figure 1.

Article 1.5.2.

Objectives

The objective of these recommendations is to provide methods for:

• 1. 

  gathering up-to-date information on the spatial and temporal distribution and abundance of vectors of the arthropod-borne OIE-listed diseases and emerging diseases ;
• 2. 

  monitoring changes in the spatial and temporal distribution and abundance of these vectors ;
• 3. 

  collecting relevant data to inform risk assessment (including vector competency) and risk management of these vector -borne di sea ses ;
• 4. 

  detecting the presence of specific vectors or confirming their absence;
• 5. 

  understanding pathways of entry for vectors and vector -borne pathogenic agents.

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Figure 1 Decision Tree for Vector Surveillance

Climate change predictions may guide risk assessment and surveillance planning

Article 1.5.3. Sampling methodology

• 1. 

  Sampling plan
• a. 

  The objective of the surveillance programme should be determined and stated before planning begins.
• b. 

  All available historical data on the vector or the disease for the country or zone should be collated and assessed.
• c. 

  The sampling plan should consider the following: i. the biology and ecology of the vector(s) ,
• ii. 

  the presence, distribution and abundance of the vectors ’ host animal population(s),
• iii. 

  the environmental, climatic, ecological and topographic conditions of relevance to vector ecology,
• iv. 

  the need for a risk assessment to indicate the areas at highest risk of introduction of a vector that is unlikely to be present.
• d. 

  Sampling should be aimed at:

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• i. 

  establishing vector presence or confirming vector absence in the country or zone ,
• ii. 

  describing the distribution of the vector(s) within the country or zone ,
• iii. 

  providing additional information on vector density and spatial/temporal variability (both over the short- and the long-term),
• iv. 

  early detection of vectors or vector -borne pathogenic agents in areas with risk s of entry and establishment.
• e. 

  The sampling plan should be designed to provide appropriate estimates of the indicators listed above. Consideration should be given to the following:

The recommended general approach to sampling is via a three-stage hierarchy:

• i. 

  Stratification based on ecological criteria (where possible), and risk assessment for vector introduction,
• ii. 

  subdivision of strata into spatial sampling units, and
• iii. 

  establishment of actual sampling sites within selected spatial sampling units.

If adequate entomological, epidemiological and historical data and/or expert opinion exists, the sampling plan may be refined or targeted by defining strata which are as homogenous homogeneous as possible with respect to the following known or suspected risk -factors, as appropriate for the country or zone :

• i. 

  domestic or wild populations of host animals preferred by the vector ,
• ii. 

  vector habitat suitability,
• iii. 

  climatic patterns (including seasonal),
• iv. 

  areas endemically and/or epidemically affected by the disease(s) of concern,
• v. 

  areas of known vector occurrences,
• vi. 

  fringe zone(s) around areas of known vector occurrences or other high risk s areas for vector introduction, such as ports,
• vii. 

  areas in which the disease(s) or vector(s) of concern have not been reported currently or historically,
• viii. 

  each stratum (or the whole country or zone , if not stratified) should be divided into spatial sampling units according to standard methodologies such as a grid system,
• ix. 

  the number and size of the spatial sampling units should be defined to provide appropriate estimates of the indicators listed above,

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• x. 

  the number and location of actual sampling sites within each spatial sampling unit also should be defined to provide appropriate estimates of the indicators listed above,
• xi. 

  different levels of sampling intensity (spatial sampling unit size, number of units sampled, number of sites sampled within units, and sampling frequency) may be applied to different strata into which the country or zone has been divided. For example, more intensive sampling might be carried out in strata where vector presence seems most likely, based on biological or statistical criteria.
• 2. 

  Sampling methods

Many sampling methods have been developed for the capture of vector arthropods, and these differ according to the disease /vector system under consideration.

• a. 

  The collection methods used should be adapted as required to ensure reasonable confidence of collecting the vector(s) of concern.
• b. 

  Collection methods should obtain the various developmental stages (such as eggs, larvae, nymphs, adults) and adult age categories, as appropriate to the species in question, required to estimate population survival rates and population dynamics in relation to disease transmission.
• c. 

  Different collection methods may be required to obtain samples from a single vector species, depending on the life stage or place of capture (such as from the environment or from the host animals). The collection method must be appropriate to the species and life stage of interest.

The collection methods should preserve the vector(s) in a manner suitable for their morphological identification or identification with molecular techniques. Where the purpose of sampling is to detect or isolate a pathogenic agent(s), specific protocols should be followed to ensure the samples are suitable for these assays.

• 3. 

  Data management, analysis and interpretation

Data management and analytical methodologies should be done in accordance with Chapter 1.4.

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Annex VI

CH AP TE R 1.6.

STATUS FOR OIE LISTED DISEASES: PROCEDURES FOR SELF DECLARATION AND FOR OFFICIAL RECOGNITION BY THE OIE

EU Comments

The EU can support the proposed changes.

Article 1.6.1.

General principles

Members may wish to make a self declaration as to the freedom of a country, zone or compartment from an OIE listed disease . The Member may inform the OIE of its claimed status and the OIE may publish the claim. Publication does not imply endorsement of the claim. The OIE does not recognise publish self declaration for bovine spongiform encephalopathy (BSE), foot and mouth disease (FMD), rinderpest and contagious bovine pleuropneumonia (CBPP).

Members may request official recognition by the OIE as to:

• 1. 

  the risk status of a country or zone with regard to BSE;
• 2. 

  the freedom of a country or zone from FMD, with or without vaccination;
• 3. 

  the freedom of a country from rinderpest;
• 4. 

  the freedom of a country or zone from CBPP.

The OIE does not grant official recognition for other diseases .

In these cases, Members should present documentation setting out the compliance of the V eterinary Services of the applicant country or zone with the provisions of Chapters 1.1., 3.1. and 3.2. of the Terrestrial Code and with the provisions of the relevant disease chapters in the Terrestrial Code and the Terrestrial Manual .

When requesting official recognition of disease status, the Member should submit to the OIE Scientific and Technical Department a dossier providing the information requested (as appropriate) in Articles 1.6.2. (for BSE), 1.6.3. (for FMD), 1.6.4. (for rinderpest) or 1.6.5. (for CBPP).

The OIE framework for the official recognition and maintenance of disease status is described in Resolution N° XXII (administrative procedures) and Resolution N° XXIII (financial obligations) adopted during the 76th General Session in May 2008.

Article 1.6.2.

Questionnaire on bovine spongiform encephalopathy

GENERAL INTRODUCTION

Acceptance of this submission is based on the compliance of the V eterinary Service of the applicant country, zone or compartment with the provisions of Chapter 3.1. of the Terrestrial Code and the compliance of BSE diagnostic

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laboratories with the provisions of Chapter 1.1.3. of the Terrestrial Manual . Documentary evidence should be provided to support this based on Chapter 3.2. of the Terrestrial Code .

Article 11.6.2. of the Terrestrial Code Chapter on BSE prescribes the criteria to determine the BSE risk status of a the cattle population of a country, zone or compartment . This document is the means whereby a claim for negligible risk (Article 11.6.3.) or controlled risk (Article 11.6.4.) can be made to the OIE.

The document comprises the following:

• • 

  Section 1 – Risk assessment (see point 1 of Article 11.6.2.)
• • 

  Section 2 – Other requirements of points 2 to 4 of Article 11.6.2. o Ongoing awareness programme o Compulsory notification and investigation o Diagnostic capability
• • 

  Section 3 – Surveillance (Article 11.6.2. and Articles 11.6.20. to 11.6.22.)
• • 

  Section 4 – BSE history of the country, zone or compartment (Articles 11.6.3. and 11.6.4.).

N.B. Where, during the completion of this questionnaire, the submitting V eterinary Service provides documentation regarding the legislation under which it is mandated, it should provide the content of any legal act described (in one of the three official languages of OIE), as well as the dates of official publication and implementation. Submitting countries are encouraged to follow the format and numbering used in this document.

SECTION 1: RISK ASSE SSMENT (see point 1 of Article 11.6.2.)

Introduction

The first step in determining the BSE risk status of the cattle population of a country, zone or compartment is to conduct a risk assessment (reviewed annually), based on Sections 2. and 3. and Chapter 4.3. of the Terrestrial Code , identifying all potential factors for BSE occurrence and their historic perspective.

Documentation guidelines

This section provides guidance on the data gathering and presentation of information required to support the risk release and exposure assessments in respect of:

Relea se assessment:

• 1. 

  The potential for the release of the BSE agent through importation of meat-and-bone meal or greaves .
• 2. 

  The potential for the release of the BSE agent through the importation of potentially infected live cattle.
• 3. 

  The potential for the release of the BSE agent through the importation of potentially infected products of bovine origin.

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Exposure a ssessment:

• 4. 

  The origin of bovine carcasses, by-products and slaughterhouse waste, the parameters of the rendering processes and the methods of cattle feed production.
• 5. 

  The potential for the exposure of cattle to the BSE agent through consumption of meat-and-bone meal or greaves of bovine origin.

In each of the five areas of release and exposure assessment that follow, the contributor is guided in terms of the question, the rationale and the evidence required to support the country, zone or compartment status claim.

Release assessment

• 1. 

  The potential for the release of the BSE agent through importation of meat-and-bone meal or greaves

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.

This point is irrelevant if the exposure assessment outlined below in Article 11.6.27. 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 cattle.

E vi dence req ui red :

• a) 

  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
• b) 

  Documentation on annual volume, by country of origin, of meat-and-bone meal , greaves or feedstuffs containing them imported during the past 8 years.
• c) 

  Documentation describing the species composition of the imported meat-and-bone meal , greaves or feedstuffs containing them.
• d) 

  Documentation, from the V eterinary Service of 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 BSE agent, should it be present.
• 2. 

  The potential for the release of the BSE agent through the importation of potentially infected live cattle

Question to be answered: Have live cattle been imported within the past 7 years?

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Rationale: The release risks are dependent on:

• • 

  country, zone or compartment 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 imported cattle in the country, zone or compartment 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 cattle 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;
• • 

  dairy versus meat breeds, where there are differences in exposure in the country, zone or compartment of origin because feeding practices result in greater exposure of one category;
• • 

  age at slaughter . E vi dence req ui red:
• a) 

  Documentation including tables on the country, zone or compartment of origin of imports. This should identify the country, zone or compartment of origin of the cattle, the length of time they lived in that country, zone or compartment and of any other country in which they have resided during their lifetime.

b)   Documentation including tables describing origin and volume of imports.

• c) 

  Documentation demonstrating that risks are periodically reviewed in light of evolving knowledge on the BSE status of the country, zone or compartment of origin.
• 3. 

  The potential for the release of the BSE agent through the importation of potentially infected products of bovine origin

Question to be answered: What products of bovine origin have been imported within the past 7 years?

Rationale: T he release risk s are dependent on:

• • 

  the origin of the cattle products and whether these products contain tissues known to contain BSE infectivity (Article 11.6.13.);
• • 

  country, zone or compartment 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 cattle in the country, zone or compartment 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 cattle 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;

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• • 

  dairy versus meat breeds, where there are differences in exposure in the country, zone or compartment of origin because feeding practices result in greater exposure of one category;
• • 

  age at slaughter . E vi dence req ui red:
• a) 

  Documentation on the country, zone or compartment of origin of imports. This should identify the country, zone or compartment of origin of cattle from which the products were derived, the length of time they lived in that country, zone or compartment and of any other country in which they have resided during their lifetime.
• b) 

  Documentation describing origin and volume of imports.
• c) 

  Documentation demonstrating that risks are periodically reviewed in light of evolving knowledge on the BSE status of the country, zone or compartment of origin.

Exposure assessment

• 4. 

  The origin of bovine carcasses, by-products and slaughterhouse waste, the parameters of the rendering processes and the methods of cattle feed production

Question to be answered: How have bovine carcasses, by-products and slaughterhouse waste been processed over the past 8 years?

Rationale: The overall risk of BSE in the cattle population of a country, zone or compartment 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, zone or compartment is of negligible or controlled BSE risk, it must have demonstrated that appropriate measures have been taken to manage any risks identified. If potentially infected cattle or contaminated materials are rendered, there is a risk that the resulting meat-and-bone meal could retain BSE infectivity. Where meat-and-bone meal is utilized in the production of any cattle feed, the risk of cross-contamination exists.

E vi dence req ui red:

• a) 

  Documentation describing the collection and disposal of fallen stock and materials condemned as unfit for human consumption.
• b) 

  Documentation including tables describing the fate of imported cattle, including their age at slaughter or death .
• c) 

  Documentation describing the definition and disposal of specified risk material, if any.
• d) 

  Documentation describing the rendering process and parameters used to produce meat-and-bone meal and greaves .
• e) 

  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.

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• f) 

  Documentation describing the end use of imported cattle products and the disposal of waste.
• g) 

  Documentation describing monitoring and enforcement of the above.
• 5. 

  The potential for the exposure of cattle to the BSE agent through consumption of meat-and-bone meal or greaves of bovine origin

Question to be answered: Has meat-and-bone meal or greaves of bovine origin been fed to cattle within the past 8 years (Articles 11.6.3. and 11.6.4. in the Terrestrial Code )?

Rationale: If cattle have not been fed products of bovine origin (other than milk or blood) potentially containing meat-and-bone meal or greaves of bovine origin within the past 8 years, meat-and-bone meal and greaves can be dismissed as a risk.

In the case of countries applying for negligible risk status, it will be required to demonstrate that the ruminant feed ban has been effective for at least 8 years following the birth of the youngest case .

E vi dence req ui red:

• a) 

  Documentation describing the use of imported meat-and-bone meal and greaves , including the feeding of any animal species.
• b) 

  Documentation describing the use made of meat-and-bone meal and greaves produced from domestic cattle, including the feeding of any animal species.
• c) 

  Documentation on the measures taken to control cross-contamination of cattle feedstuffs with the meat-and-bone meal and greaves including the risk of cross-contamination during production, transport, storage and feeding.
• d) 

  Documentation, in the form of the following table, on the audit findings in rendering plants and feed mills processing ruminant material or mixed species containing ruminant material, related to the prohibition of the feeding to ruminants of meat-and-bone meal and greaves .

Year (information

should be

provided for

each of the 8

years for

effectiveness is

claimed)

Year 1

Year 2, etc.

Type of

plant

(renderer

or feed

mill)

Renderer

Feed mill

Renderer

Feed mill

Number of plants

processing ruminant material

(A)

Number of plants in

(A) inspected

(B)

Total number of

visual inspections

in (B)

Total

number of plants in (B) with

infractions

Total number of inspected plants in (B) with sampling

Total

number

of plants

in (C)

with

positive

test results

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• e) 

  Documentation, in the form of the following table, on the audit findings in rendering plants and feed mills processing non-ruminant material, related to the prohibition of the feeding of meat-and-bone meal and greaves to ruminants.

• f) 

  Documentation, in the form of the following table, on each plant above processing ruminant material or mixed species containing ruminant material with infractions, specifying the type of infraction and the method of resolution.

Year (information should be provided for each of the 8 years for effectiveness is claimed)

Type of plant

(renderer or feed

mill)

Renderer

Year 1

Feed mill

Renderer

Year 2, etc.

Feed mill

Nature of infraction

Method of resolution

Follow-up results

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• g) 

  Documentation, in the form of the following table, on each plant above processing non-ruminant material with infractions, specifying the type of infraction and the method of resolution.

Year (information should be provided for each of the 8 years for effectiveness is claimed)

• h) 

  Documentation explaining why, in light of the findings displayed in the preceding four tables, it is considered that there has been no significant exposure of cattle to the BSE agent through consumption of meat-and-bone meal or greaves of bovine origin.
• i) 

  Documentation of husbandry practices (multiple species farms) which could lend themselves to cross-contamination of cattle feed with meat-and-bone meal and greaves destined to other species.

SECTION 2: OTHER REQUIREMENTS (see points 2 to 4 of Article 11.6.2.)

• 1. 

  Awareness programme (see point 2 of Article 11.6.2.)

Questi ons to be a nswered:

o Is there an awareness programme?

o What is the target audience?

o What is the curriculum and how long has it been in place?

o Is there a contingency and/or preparedness plan that deals with BSE?

Rationale:

An awareness programme is essential to ensure detection and reporting of BSE, especially in countries of low prevalence and competing differential diagnoses.

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E vi dence req ui red:

• a) 

  Documentation indicating when the awareness programme was instituted and its continuous application and geographical coverage.
• b) 

  Documentation on the number and occupation of persons who have participated in the awareness programme (veterinarians, producers, workers at auctions, slaughterhouses , etc.).
• c) 

  Documentation of materials used in the awareness programme (the manual, supportive documents, or other teaching materials).
• d) 

  Documentation on the contingency plan.
• 2. 

  Compulsory notification and investigation (see point 3 of Article 11.6.2.)

Questi ons to be a nswered:

o What guidance is given to veterinarians, producers, workers at auctions, slaughterhouses , etc.) in terms of the criteria that would initiate the investigation of an animal as a BSE suspect? Have these criteria evolved?

o What were the date and content of the legal act making notification of BSE suspects compulsory?

o What are the measures in place to stimulate notification, such as compensation payments or penalties for not notifying a suspect?

Rationale:

The socio-economic implications associated with BSE require that there be incentives and/or obligations to notify and investigate suspect cases .

Evidence req ui red:

• a) 

  Documentation on the date of official publication and implementation of compulsory notification. Including a brief description of incentives and penalties.
• b) 

  Documentation on the manual of procedures for investigation of suspect animals and follow-up of positive findings.
• 3. 

  Examination in an approved laboratory of brain or other tissues collected within the framework of the aforementioned surveillance system (see point 4 of Article 11.6.2.)

Questi ons to be a nswered:

o Are the diagnostic procedures and methods those described in Chapter 2.4.6. of the Terrestrial Manual ?

o Have these diagnostic procedures and methods been applied through the entire surveillance period?

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Rationale:

The OIE only recognizes for the purpose of this submission samples that have been tested in accordance with the Terrestrial Manual.

E vi dence req ui red:

• a) 

  Documentation as to the approved laboratories where samples of cattle tissues from the country, zone or compartment are examined for BSE. (If this is located outside the country, information should be provided on the cooperation agreement).
• b) 

  Documentation of the diagnostic procedures and methods used.
• c) 

  Documentation that the diagnostic procedures and methods have been applied through the entire surveillance period.

SECTION 3: BSE SURVEILLANCE AND MONITORING SYSTEM (see point 4 of Article 11.6.2.)

Questions to be a nswered:

o Does the BSE surveillance programme comply with the guidelines in Articles 11.6.20. to 11.6.22. of the T errestrial C ode ?

o What were the results of the investigations?

Rati onale:

Point 4 of Article 11.6.2. and Articles 11.6.20. to 11.6.22. prescribe the number of cattle, by subpopulation, that need to be tested in order to ensure the detection of BSE at or above a minimal threshold prevalence.

E vi dence req ui red:

• 1. 

  Documentation that the samples collected are representative of the distribution of cattle population in the country, zone or compartment .
• 2. 

  Documentation of the methods applied to assess the ages of animals sampled and the proportions for each method (individual identification, dentition, other methods to be specified).
• 3. 

  Documentation of the means and procedures whereby samples were assigned to the cattle subpopulations described in Article 11.6.21., including the specific provisions applied to ensure that animals described as clinical met the conditions of point 1 of Article 11.6.21.
• 4. 

  Documentation of the number of animals meeting the conditions in point 1 of Article 11.6.21. as compared to the numbers of clinical samples submitted in previous years in accordance to the former provisions in the T errestrial C ode , and explanation of possible differences.
• 5. 

  Documentation, based on the following table, of all clinically suspect cases notified complying with the definition in point 1 of Article 11.6.21.

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Laboratory identification number

Point of detection

(farm, market channels,

slaughterhouse)

• 6. 

  Documentation according to the following table, that the number of target points applicable to the country, zone or compartment and its BSE surveillance requirements (Type A or type B surveillance as a result of the risk assessment of section 1) are met as described in Articles 11.6.21. and 11.6.22.

SUMMARY TABLE FOR BSE SURVEILLANCE

Year: (complete a separate table for each year of surveillance)

Surveillance subpopulations

• 7. 

  Indicate the number of adult cattle (over 24 months of age) in the country, zone or compartment .

SECTION 4: BSE HISTORY OF THE COUNTRY, ZONE OR COMPARTMENT (see Articles 11.6.3. and 11.6.4.)

Questions to be a nswered:

• • 

  Has BSE occurred in the country, zone or compartment ?
• • 

  How has it been dealt with?

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Rati onale:

The categorization of a country, zone or compartment in either negligible or controlled risk is dependent upon, the outcome of the risk assessment described in section 1, compliance with the provisions described in section 2, the results of surveillance described in section 3, and the history of BSE in the country, zone or compartment . This section provides the opportunity to describe the BSE history in the country, zone or compartment .

E vi dence required:

• 1. 

  Documentation of whether a case of BSE has ever been diagnosed in the country, zone or compartment . In the case of positive BSE findings:
• 2. 

  Documentation on the origin of each BSE case in respect to the country, zone or compartment . Indicate the birth date and place of birth.
• 3. 

  Indicate the most recent year of birth in relation to all BSE cases .
• 4. 

  Documentation that:

o

o

o

o

the case(s) and 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 1.6.3.

Questionnaire on foot and mouth disease

FMD FREE COUNTRY WHERE VACCINATION IS NOT PRACTISED

Report of a Member which applies for recognition of status, under Chapter 8.5. of the Terrestrial A nimal H ealth Code (2009), as a FMD free country not practising vaccination

Please address concisely the following topics. National regulations laws and Veterinary Administration directives may be referred to and annexed as appropriate in one of the OIE official languages.

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• 1. 

  Introduction
• a) 

  Geographical factors. Provide a general description of the country including physical, geographical and other factors that are relevant to FMD dissemination, countries sharing common borders and other countries that although may not be adjacent share a link for the potential introduction of disease . Provide a map identifying the factors above.
• b) 

  Livestock industry. Provide a general description of the livestock industry in the country.
• 2. 

  Veterinary system
• a) 

  Legislation. Provide a list and summary of all relevant veterinary legislation in relation to FMD.
• b) 

  Veterinary Services. Provide documentation on the compliance of the V eterinary Service of the country with the provisions of Chapters 3.1. and 3.2. of the Terrestrial Code and 1.1.3. of the Terrestrial Manual and describe how the Veterinary Services supervise and control all FMD related activities. Provide maps and tables wherever possible.
• c) 

  Role of farmers, industry and other relevant groups in FMD surveillance and control (include a description of training and awareness programmes on FMD).
• d) 

  Role of private veterinary profession in FMD surveillance and control.
• 3. 

  FMD eradication
• a) 

  History. Provide a description of the FMD history in the country, date of first detection, origin of infection , date of eradication (date of last case ), types and subtypes present.
• b) 

  Strategy. Describe how FMD was controlled and eradicated (e.g. stamping-out, modified stamping-out, zoning), provide timeframe for eradication.
• c) 

  Vaccines and vaccination. Was FMD vaccine ever used? If so, when was the last vaccination carried out? What species were vaccinated?
• d) 

  Legislation, organisation and implementation of the FMD eradication campaign. Provide a description of the organizational structure at the different levels. Indicate if detailed operational guidelines exist and give a brief summary.
• e) 

  Animal identification and movement control. Are susceptible animals identified (individually or at a group level)? Provide a description of the methods of animal identification, herd registration and traceability. How are animal movements controlled in the country? Provide evidence on the effectiveness of animal identification and movement controls. Please provide information on pastoralism, transhumance and related paths of movement.
• 4. 

  FMD diagnosis

Provide documentary evidence that the provisions in Chapters 1.1.2., 1.1.3., and 2.1.5. of the Terrestrial Manual are applied. In particular, the following points should be addressed:

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• a) 

  Is FMD laboratory diagnosis carried out in the country? If so, provide a list of approved laboratories. If not, provide the name(s) of and the arrangements with the laboratory(ies) samples are sent to, the follow-up procedures and the time frame for obtaining results.
• b) 

  Provide an overview of the FMD approved laboratories, in particular to address the following points:
• i) 

  Procedures for the official accreditation of laboratories. Give details of internal quality management systems, e.g. Good Laboratory Practice, ISO, etc. that exist in, or planned for, the laboratory system.
• ii) 

  Give details of participation in inter-laboratory validation tests (ring tests).
• iii) 

  Is live virus handled?
• iv) 

  Biosecurity measures applied.
• v) 

  Details of the type of tests undertaken.
• 5. 

  FMD surveillance

Provide documentary evidence that surveillance for FMD in the country complies with the provisions of Articles 8.5.40. to 8.5.46. of the Terrestrial Code and Chapter 2.1.5. of the Terrestrial Manual . In particular, the following points should be addressed:

• a) 

  Clinical suspicion. What are the criteria for raising a suspicion of FMD? What is the procedure to notify (by whom and to whom) and what penalties are involved for failure to report? Provide a summary table indicating, for the past two years, the number of suspect cases , the number of samples tested for FMDV, species, type of sample, testing method(s) and results (including differential diagnosis).
• b) 

  Serological surveillance. Are serological surveys conducted? If so, provide detailed information on the survey design (confidence level, sample size, stratification). How frequently are they conducted? Are wildlife susceptible species included in serological surveys? Provide a summary table indicating, for the past t wo years, the number of samples tested for FMDV, species, type of sample, testing method(s) and results (including differential diagnosis). Provide details on follow-up actions taken on all suspicious and positive results. Provide criteria for selection of populations for targeted surveillance and numbers of animals examined and samples tested. Provide details on the methods applied for monitoring the performance of the surveillance system including indicators.
• c) 

  Livestock demographics and economics. What is the susceptible animal population by species and production systems? How many herds , flock s , etc., of each susceptible species are in the country? How are they distributed (e.g. herd density, etc.)? Provide tables and maps as appropriate.
• d) 

  Wildlife demographics. What susceptible species are present in the country? Provide estimates of population sizes and geographic distribution. What are the measures in place to prevent contact between domestic and wildlife susceptible species?
• e) 

  Slaughterhouses and markets. Where are the major livestock marketing or collection centres? What are the patterns of livestock movement within the country? How are the animals transported and handled during these transactions?

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Annex VI (contd)

• 6. 

  FMD prevention
• a) 

  Coordination with neighbouring countries. Are there any relevant factors about the adjacent countries or zones that should be taken into account (e.g. size, distance from adjacent border to affected herds or animals )? Describe coordination, collaboration and information sharing activities with neighbouring countries.
• b) 

  Import control procedures

From what countries or zones does the country authorize the import of susceptible animals or their products? What criteria are applied to approve such countries or zones ? What controls are applied on entry of such animals and products, and subsequent internal movement? What import conditions and test procedures are required? Are imported animals of susceptible species required to undergo a quarantine or isolation period? If so, for how long and where? Are import permits and health certificates required? What other procedures are used? Provide summary statistics of imports of susceptible animals and their products for the past t wo years, specifying country or zone of origin, species and volume.

• i) 

  Provide a map with the number and location of ports, airports and land crossings. Is the official service responsible for import controls part of the official services, or is it an independent body? If it is an independent body, describe its management structure, staffing levels and resources, and its accountability to the central V eterinary Services . Describe the communication systems between the central authorities and the border inspection posts, and between border inspection posts.
• ii) 

  Provide a description on the methods used for the safe disposal of waste from international traffic, who is responsible and provide a summary, for the past two years, of the quantity disposed of.
• iii) 

  Describe the regulations, procedures, type and frequency of checks at the point of entry into the country and/or their final destination, concerning the import and follow-up of the following:

§    a ni mals ,

§    genetic material (semen and embryos),

§    animal products,

§    veterinary medicinal products (i.e. biologics).

• iv) 

  Describe the action available under legislation, and actually taken, when an illegal import is detected. Provide information on detected illegal imports.
• 7. 

  Control measures and contingency planning
• a) 

  Give details of any written guidelines, including contingency plans, available to the official services for dealing with suspected or confirmed outbreak s of FMD.
• b) 

  Is quarantine imposed on premises with suspicious cases , pending final diagnosis? What other procedures are followed regarding suspicious cases ?

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Annex VI (contd)

• c) 

  In the event of an FMD outbreak :
• i) 

  indicate the sampling and testing procedures used to identify and confirm presence of the causative agent;
• ii) 

  describe the actions taken to control the disease situation in and around any holdings found to be infected with FMD;
• iii) 

  indicate the control and/or eradication procedures (e.g. vaccination, stamping-out, partial slaughter /vaccination, etc.) that would be taken. Include details on antigen and vaccine banks;
• iv) 

  describe the procedures used to confirm that an outbreak has been successfully controlled/eradicated, including any restrictions on restocking;
• v) 

  give details of any compensation payments made available to farmers, etc. when animals are slaughtered for disease control/eradication purposes and their prescribed timetable.
• 8. 

  Compliance with the Terrestrial Code
• a) 

  In addition to the documentary evidence that the provisions of Article 8.5.2. are properly implemented and supervised, the Delegate of the country must submit a declaration indicating:
• i) 

  there has been no outbreak of FMD during the past 12 months;
• ii) 

  no evidence of FMDV infection has been found during the past 12 months;
• iii) 

  no vaccination against FMD has been carried out during the past 12 months,
• b) 

  and should confirm that since the cessation of vaccination no animals vaccinated against FMD have been imported.
• 9. 

  Recovery of status

Countries applying for recovery of status should comply with the provisions of Article 8.5.8. of the Terrestrial Code and provide detailed information as specified in sections 3.a), 3.b), 3.c) and 5.b) of this questionnaire. Information in relation to other sections need only be supplied if relevant.

FMD FREE COUNTRY WHERE VACCINATION IS PRACTISED

Report of a Member which applies for recognition of status, under Chapter 8.5. of the Terrestrial A nimal H ealth Code (2009), as a FMD free country practising vaccination

Please address concisely the following topics. National regulations laws and Veterinary Administration directives may be referred to and annexed as appropriate in one of the OIE official languages.

• 1. 

  Introduction
• a) 

  Geographical factors. Provide a general description of the country including physical, geographical and other factors that are relevant to FMD dissemination, countries sharing common borders and other countries that although may not be adjacent share a link for the potential introduction of disease . Provide a map identifying the factors above.

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Annex VI (contd)

• b) 

  Livestock industry. Provide a general description of the livestock industry in the country.
• 2. 

  Veterinary system
• a) 

  Legislation. Provide a list and summary of all relevant veterinary legislation in relation to FMD.
• b) 

  Veterinary Services. Provide documentation on the compliance of the V eterinary Service of the country with the provisions of Chapters 3.1. and 3.2. of the Terrestrial Code and 1.1.3. of the Terrestrial Manual and describe how the V eterinary Services supervise and control all FMD related activities in the country and in the zone . Provide maps and tables wherever possible.
• c) 

  Role of farmers, industry and other relevant groups in FMD surveillance and control (include a description of training and awareness programmes on FMD).
• d) 

  Role of private veterinary profession in FMD surveillance and control.
• 3. 

  FMD eradication
• a) 

  History. Provide a description of the FMD history in the country, provide date of first detection, origin of infection , date of eradication (date of last case ), types and subtypes present.
• b) 

  Strategy. Describe how FMD was controlled and eradicated (e.g. stamping-out, modified stamping-out, zoning), provide timeframe for eradication.
• c) 

  Vaccines and vaccination. What type of vaccine is used? What species are vaccinated? Provide evidence that the vaccine used complies with Chapter 2.1.5. of the Terrestrial Manual . Describe the vaccination programme, including records kept, and provide evidence to show its effectiveness (e.g. vaccination coverage, serosurveillance, etc.).
• d) 

  Legislation, organisation and implementation of the FMD eradication campaign. Provide a description of the organizational structure at the different levels. Indicate if detailed operational guidelines exist and give a brief summary.
• e) 

  Animal identification and movement control. Are susceptible animals identified (individually or at a group level)? Provide a description of the methods of animal identification, herd registration and traceability, including vaccination data. How are animal movements controlled in the country? Provide evidence on the effectiveness of animal identification and movement controls. Please provide information on pastoralism, transhumance and the related paths of movement.
• 4. 

  FMD diagnosis

Provide documentary evidence that the provisions in Chapters 1.1.2., 1.1.3. and 2.1.5. of the Terrestrial Manual are applied. In particular, the following points should be addressed:

• a) 

  Is FMD laboratory diagnosis carried out in the country? If so, provide a list of approved laboratories. If not, provide the name(s) of and the arrangements with the laboratory(ies) samples are sent to and the follow-up procedures and the timeframe for obtaining results.
• b) 

  Provide an overview of the FMD approved laboratories, in particular to address the following points:

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Annex VI (contd)

• i) 

  Procedures for the official accreditation of laboratories. Give details of internal quality management systems, e.g. Good Laboratory Practice, ISO, etc. that exist in, or planned for, the laboratory system.
• ii) 

  Give details of participation in inter-laboratory validation tests (ring tests).
• iii) 

  Is live virus handled?
• iv) 

  Biosecurity measures applied.
• v) 

  Details of the type of tests undertaken.
• 5. 

  FMD surveillance

Provide documentary evidence that surveillance for FMD in the country complies with the provisions of Articles 8.5.40. to 8.5.46. of the Terrestrial Code and Chapter 2.1.5. of the Terrestrial Manual . In particular, the following points should be addressed:

• a) 

  Clinical suspicion. What are the criteria for raising a suspicion of FMD? What is the procedure to notify (by whom and to whom) and what penalties are involved for failure to report? Provide a summary table indicating, for the past two years, the number of suspect cases , the number of samples tested for FMDV, species, type of sample, testing method(s) and results (including differential diagnosis).
• b) 

  Surveillance. Are serological and virological surveys conducted, in particular applying the provisions of Article 8.5.44.? If so, provide detailed information on the survey design (confidence level, sample size, stratification). How frequently are they conducted? Are wildlife susceptible species included in serological surveys? Provide a summary table indicating, for the past t wo years, the number of samples tested for FMD and FMDV, species, type of sample, testing method(s) and results (including differential diagnosis). Provide details on follow-up actions taken on all suspicious and positive results. Provide criteria for selection of populations for targeted surveillance and numbers of animals examined and samples tested. Provide details on the methods applied for monitoring the performance of the surveillance system including indicators.
• c) 

  Livestock demographics and economics. What is the susceptible animal population by species and production systems? How many herds , flock s , etc., of each susceptible species are in the country? How are they distributed (e.g. herd density, etc.)? Provide tables and maps as appropriate.
• d) 

  Wildlife demographics. What susceptible species are present in the country? Provide estimates of population sizes and geographic distribution. What are the measures in place to prevent contact between domestic and wildlife susceptible species?
• e) 

  Slaughterhouses and markets. Where are the major livestock marketing or collection centres? What are the patterns of livestock movement within the country? How are the animals transported and handled during these transactions?
• 6. 

  FMD prevention
• a) 

  Coordination with neighbouring countries. Are there any relevant factors about the adjacent countries or zones that should be taken into account (e.g. size, distance from adjacent border to affected herds or animals )? Describe coordination, collaboration and information sharing activities with neighbouring countries.
• b) 

  Import control procedures

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From what countries or zones does the country authorize the import of susceptible animals or their products? What criteria are applied to approve such countries or zones ? What controls are applied on entry of such animals and products, and subsequent internal movement? What import conditions and test procedures are required? Are imported animals of susceptible species required to undergo a quarantine or isolation period? If so, for how long and where? Are import permits and health certificates required? What other procedures are used? Provide summary statistics of imports of susceptible animals and their products for the past t wo years, specifying country or zone of origin, species and volume.

• i) 

  Provide a map with the number and location of ports, airports and land crossings. Is the official service responsible for import controls part of the official services, or is it an independent body? If it is an independent body, describe its management structure, staffing levels and resources, and its accountability to the central V eterinary Services . Describe the communication systems between the central authorities and the border inspection posts, and between border inspection posts.
• ii) 

  Provide a description on the methods used for the safe disposal of waste from international traffic, who is responsible and provide a summary, for the past two years, of the quantity disposed of.
• iii) 

  Describe the regulations, procedures, type and frequency of checks at the point of entry into the country and/or their final destination, concerning the import and follow-up of the following:
• - 

  animals ,
• - 

  genetic material (semen and embryos),
• - 

  animal products,
• - 

  veterinary medicinal products (i.e. biologics).
• iv) 

  Describe the action available under legislation, and actually taken, when an illegal import is detected. Provide information on detected illegal imports.
• 7. 

  Control measures and contingency planning
• a) 

  Give details of any written guidelines, including contingency plans, available to the official services for dealing with suspected or confirmed outbreak s of FMD.

b)` Is quarantine imposed on premises with suspicious cases , pending final diagnosis? What other procedures are followed regarding suspicious cases ?

• c) 

  In the event of an FMD outbreak :
• i) 

  indicate the sampling and testing procedures used to identify and confirm presence of the causative agent;
• ii) 

  describe the actions taken to control the disease situation in and around any holdings found to be infected with FMD;

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Annex VI (contd)

• iii) 

  indicate the control and/or eradication procedures (e.g. vaccination, stamping-out, partial slaughter /vaccination, etc.) that would be taken. Include details on antigen and vaccine banks;
• iv) 

  describe the procedures used to confirm that an outbreak has been successfully controlled/eradicated, including any restrictions on restocking;
• v) 

  give details of any compensation payments made available to farmers, etc. when animals are slaughtered for disease control/eradication purposes and their prescribed timetable.
• 8. 

  Compliance with the Terrestrial Code

In addition to the documentary evidence that the provisions of Article 8.5.3. are properly implemented and supervised, the Delegate of the country must submit a declaration indicating 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 Articles 8.5.40. to 8.5.46. 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 .
• 9. 

  Recovery of status

Countries applying for recovery of status should comply with the provisions of Article 8.5.8. of the Terrestrial Code and provide detailed information as specified in sections 3.a), 3.b), 3.c) and 5.b) of this questionnaire. Information in relation to other sections need only be supplied if relevant.

FMD FREE ZONE WHERE VACCINATION IS NOT PRACTISED

Report of a Member which applies for recognition of status, under Chapter 8.5. of the Terrestrial A nimal H ealth Code (2009), as a FMD free zone not practising vaccination

Please address concisely the following topics. National regulations laws and Veterinary Administration directives may be referred to and annexed as appropriate in one of the OIE official languages.

• 1. 

  Introduction
• a) 

  Geographical factors. Provide a general description of the country and the zone including physical, geographical and other factors that are relevant to FMD dissemination, countries or zones sharing common borders and other countries or zones that although may not be adjacent share a link for the potential introduction of disease . The boundaries of the zone must be clearly defined, including a protection zone if applied. Provide a digitalised, geo-referenced map with a precise text description of the geographical boundaries of the z one .
• b) 

  Livestock industry. Provide a general description of the livestock industry in the country and the zone .

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Annex VI (contd)

• 2. 

  Veterinary system
• a) 

  Legislation. Provide a list and summary of all relevant veterinary legislation in relation to FMD.
• b) 

  Veterinary Services. Provide documentation on the compliance of the V eterinary Service of the country with the provisions of Chapters 3.1. and 3.2. of the Terrestrial Code and 1.1.3. of the Terrestrial Manual and describe how the V eterinary Services supervise and control all FMD related activities in the country and in the zone . Provide maps and tables wherever possible.
• c) 

  Role of farmers, industry and other relevant groups in FMD surveillance and control (include a description of training and awareness programmes on FMD).
• d) 

  Role of private veterinary profession in FMD surveillance and control.
• 3. 

  FMD eradication
• a) 

  History. Provide a description of the FMD history in the country and zone , provide date of first detection, origin of infection , date of eradication in the zone (date of last case ), types and subtypes present.
• b) 

  Strategy. Describe how FMD was controlled and eradicated in the zone (e.g. stamping-out, modified stamping-out), provide timeframe for eradication.
• c) 

  Vaccines and vaccination. If vaccination is used in the rest of the country, what type of vaccine is used? What species are vaccinated? Provide evidence that the vaccine used complies with Chapter 2.1.5. of the Terrestrial Manual . Describe the vaccination programme, including records kept, and provide evidence to show its effectiveness (e.g. vaccination coverage, serosurveillance, etc.).
• d) 

  Legislation, organisation and implementation of the FMD eradication campaign. Provide a description of the organizational structure at the different levels. Indicate if detailed operational guidelines exist and give a brief summary.
• e) 

  Animal identification and movement control. Are susceptible animals identified (individually or at a group level)? Provide a description of the methods of animal identification, herd registration and traceability. How are animal movements controlled in and between zones of the same or different status, in particular if the provisions of the Terrestrial Code in Article 8.5.9. are applied? Provide evidence on the effectiveness of animal identification and movement controls. Please provide information on pastoralism, transhumance and the related paths of movement.
• 4. 

  FMD diagnosis

Provide documentary evidence that the provisions in Chapters 1.1.2., 1.1.3. and 2.1.5. of the Terrestrial Manual are applied. In particular, the following points should be addressed:

• a) 

  Is FMD laboratory diagnosis carried out in the country? If so, provide a list of approved laboratories. If not, provide the name(s) of and the arrangements with the laboratory(ies) samples are sent to. Indicate the laboratory(ies) where samples originating from the zone are diagnosed, the follow-up procedures and the time frame for obtaining results.

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Annex VI (contd)

• b) 

  Provide an overview of the FMD approved laboratories, in particular to address the following points:
• a) 

  Procedures for the official accreditation of laboratories. Give details of internal quality management systems, e.g. Good Laboratory Practice, ISO, etc. that exist in, or planned for, the laboratory system.
• b) 

  Give details of participation in inter-laboratory validation tests (ring tests).
• c) 

  Is live virus handled?
• d) 

  Biosecurity measures applied.
• e) 

  Details of the type of tests undertaken.
• 5. 

  FMD surveillance

Provide documentary evidence that surveillance for FMD in the zone complies with the provisions of Articles 8.5.40. to 8.5.46. of the Terrestrial Code and Chapter 2.1.5. of the Terrestrial Manual . In particular, the following points should be addressed:

• a) 

  Clinical suspicion. What are the criteria for raising a suspicion of FMD? What is the procedure to notify (by whom and to whom) and what penalties are involved for failure to report? Provide a summary table indicating, for the past 2 years, the number of suspect cases , the number of samples tested for FMDV, species, type of sample, testing method(s) and results (including differential diagnosis).
• b) 

  Serological surveillance. Are serological surveys conducted? If so, provide detailed information on the survey design (confidence level, sample size, stratification). How frequently are they conducted? Are wildlife susceptible species included in serological surveys? Provide a summary table indicating, for the past 2 years, the number of samples tested for FMDV, species, type of sample, testing method(s) and results (including differential diagnosis). Provide details on follow-up actions taken on all suspicious and positive results. Provide criteria for selection of populations for targeted surveillance and numbers of animals examined and samples tested. Provide details on the methods applied for monitoring the performance of the surveillance system including indicators.
• c) 

  Livestock demographics and economics. What is the susceptible animal population by species and production systems in the country and the zone ? How many herds , flock s , etc., of each susceptible species are in the country? How are they distributed (e.g. herd density, etc.)? Provide tables and maps as appropriate.
• d) 

  Wildlife demographics. What susceptible species are present in the country and the zone ? Provide estimates of population sizes and geographic distribution. What are the measures in place to prevent contact between domestic and wildlife susceptible species?
• e) 

  Slaughterhouses and markets. Where are the major livestock marketing or collection centres? What are the patterns of livestock movement within the country? How are the animals transported and handled during these transactions?

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Annex VI (contd)

• 6. 

  FMD prevention
• a) 

  Coordination with neighbouring countries. Are there any relevant factors about the adjacent countries and zones that should be taken into account (e.g. size, distance from adjacent border to affected herds or animals )? Describe coordination, collaboration and information sharing activities with neighbouring countries and z ones .

If the FMD free zone without vaccination is situated in an FMD infected country or borders an infected country or zone , describe the animal health measures implemented to effectively prevent the introduction of the agent, taking into consideration physical or geographical barriers.

• b) 

  Import control procedures

From what countries or zones does the country authorize the import of susceptible animals or their products into a free zone ? What criteria are applied to approve such countries or zones ? What controls are applied on entry of such animals and products, and subsequent internal movement? What import conditions and test procedures are required? Are imported animals of susceptible species required to undergo a quarantine or isolation period? If so, for how long and where? Are import permits and health certificates required? What other procedures are used? Provide summary statistics of imports of susceptible animals and their products for the past 2 years, specifying country or zone of origin, species and volume.

• i) 

  Provide a map with the number and location of ports, airports and land crossings. Is the official service responsible for import controls part of the official services, or is it an independent body? If it is an independent body, describe its management structure, staffing levels and resources, and its accountability to the central V eterinary Services . Describe the communication systems between the central authorities and the border inspection posts, and between border inspection posts.
• ii) 

  Provide a description on the methods used for the safe disposal of waste from international traffic, who is responsible and provide a summary, for the past 2 years, of the quantity disposed of.
• iii) 

  Describe the regulations, procedures, type and frequency of checks at the point of entry into the country and/or their final destination, concerning the import and follow-up of the following:
• - 

  animals ,
• - 

  genetic material (semen and embryos),
• - 

  animal products,
• - 

  veterinary medicinal products (i.e. biologics).
• iv) 

  Describe the action available under legislation, and actually taken, when an illegal import is detected. Provide information on detected illegal imports.

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Annex VI (contd)

• 7. 

  Control measures and contingency planning
• a) 

  Give details of any written guidelines, including contingency plans, available to the official services for dealing with suspected or confirmed outbreak s of FMD.
• b) 

  Is quarantine imposed on premises with suspicious cases , pending final diagnosis? What other procedures are followed regarding suspicious cases ?
• c) 

  In the event of an FMD outbreak :
• i) 

  indicate the sampling and testing procedures used to identify and confirm presence of the causative agent;
• ii) 

  describe the actions taken to control the disease situation in and around any holdings found to be infected with FMD;
• iii) 

  indicate the control and/or eradication procedures (e.g. vaccination, stamping-out, partial slaughter /vaccination, etc.) that would be taken. Include details on antigen and vaccine banks;
• iv) 

  describe the procedures used to confirm that an outbreak has been successfully controlled/eradicated, including any restrictions on restocking;
• v) 

  give details of any compensation payments made available to farmers, etc. when animals are slaughtered for disease control/eradication purposes and their prescribed timetable.
• 8. 

  Compliance with the Terrestrial Code

In addition to the documentary evidence that the provisions of Article 8.5.4. are properly implemented and supervised, the Delegate of the country must submit a declaration indicating:

• 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 8.5.9.
• 9. 

  Recovery of status

Countries applying for recovery of status should comply with the provisions of Article 8.5.8. of the Terrestrial Code and provide detailed information as specified in sections 3.a), 3.b), 3.c) and 5.b) of this questionnaire. Information in relation to other sections need only be supplied if relevant.

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Annex VI (contd)

FMD FREE ZONE WHERE VACCINATION IS PRACTISED

Report of a Member which applies for recognition of status, under Chapter 8.5. of the Terrestrial A nimal H ealth Code (2009), as a FMD free zone practising vaccination

Please address concisely the following topics. National regulations laws and Veterinary Administration directives may be referred to and annexed as appropriate in one of the OIE official languages.

• 1. 

  Introduction
• a) 

  Geographical factors. Provide a general description of the country and the zone including physical, geographical and other factors that are relevant to FMD dissemination, countries or zones sharing common borders and other countries or zones that although may not be adjacent share a link for the potential introduction of disease . The boundaries of the zone must be clearly defined, including a protection zone if applied. Provide a digitalised, geo-referenced map with a precise text description of the geographical boundaries of the z one .
• b) 

  Livestock industry. Provide a general description of the livestock industry in the country and the zone .
• 2. 

  Veterinary system
• a) 

  Legislation. Provide a list and summary of all relevant veterinary legislation in relation to FMD.
• b) 

  Veterinary Services. Provide documentation on the compliance of the V eterinary Service of the country with the provisions of Chapters 3.1. and 3.2. of the Terrestrial Code and 1.1.3. of the Terrestrial Manual and describe how the V eterinary Services supervise and control all FMD related activities in the country and in the zone . Provide maps and tables wherever possible.
• c) 

  Role of farmers, industry and other relevant groups in FMD surveillance and control (include a description of training and awareness programmes on FMD).
• d) 

  Role of private veterinary profession in FMD surveillance and control.
• 3. 

  FMD eradication
• a) 

  History. Provide a description of the FMD history in the country and zone , provide date of first detection, origin of infection , date of eradication in the zone (date of last case ), types and subtypes present.
• b) 

  Strategy. Describe how FMD was controlled and eradicated in the zone (e.g. stamping-out, modified stamping-out), provide timeframe for eradication.
• c) 

  Vaccines and vaccination. What type of vaccine is used? What species are vaccinated? Provide evidence that the vaccine used complies with Chapter 2.1.5. of the Terrestrial Manual . Describe the vaccination programme in the country and in the zone , including records kept, and provide evidence to show its effectiveness (e.g. vaccination coverage, serosurveillance, etc.).
• d) 

  Legislation, organisation and implementation of the FMD eradication campaign. Provide a description of the organizational structure at the different levels. Indicate if detailed operational guidelines exist and give a brief summary.

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• e) 

  Animal identification and movement control. Are susceptible animals identified (individually or at a group level)? Provide a description of the methods of animal identification, herd registration and traceability, including vaccination data. How are animal movements controlled in and between zones of the same or different status, in particular if the provisions of the Terrestrial Code in Article 8.5.9. are applied? Provide evidence on the effectiveness of animal identification and movement controls. Please provide information on pastoralism, transhumance and the related paths of movement.
• 4. 

  FMD diagnosis

Provide documentary evidence that the provisions in Chapters 1.1.2., 1.1.3. and 2.1.5. of the Terrestrial Manual are applied. In particular, the following points should be addressed:

• a) 

  Is FMD laboratory diagnosis carried out in the country? If so, provide a list of approved laboratories. If not, provide the name(s) of and the arrangements with the laboratory(ies) samples are sent to, the follow-up procedures and the time frame for obtaining results. Indicate the laboratory(ies) where samples originating from the zone are diagnosed.
• b) 

  Provide an overview of the FMD approved laboratories, in particular to address the following points.
• i) 

  Procedures for the official accreditation of laboratories. Give details of internal quality management systems, e.g. Good Laboratory Practice, ISO, etc. that exist in, or planned for, the laboratory system.
• ii) 

  Give details of participation in inter-laboratory validation tests (ring tests).
• iii) 

  Is live virus handled?
• iv) 

  Biosecurity measures applied.
• v) 

  Details of the type of tests undertaken.
• 5. 

  FMD surveillance

Provide documentary evidence that surveillance for FMD in the zone complies with the provisions of Articles 8.5.40. to 8.5.46. of the Terrestrial Code and Chapter 2.1.5. of the Terrestrial Manual . In particular, the following points should be addressed:

• a) 

  Clinical suspicion. What are the criteria for raising a suspicion of FMD? What is the procedure to notify (by whom and to whom) and what penalties are involved for failure to report? Provide a summary table indicating, for the past 2 years, the number of suspect cases , the number of samples tested for FMDV, species, type of sample, testing method(s) and results (including differential diagnosis).
• b) 

  Surveillance. Are serological and virological surveys conducted, in particular applying the provisions of Article 8.5.44.? If so, provide detailed information on the survey design (confidence level, sample size, stratification). How frequently are they conducted? Are wildlife susceptible species included in serological surveys? Provide a summary table indicating, for the past 2 years, the number of samples tested for FMD and FMDV, species, type of sample, testing method(s) and results (including differential diagnosis). Provide details on follow-up actions taken on all suspicious and positive results. Provide criteria for selection of populations for targeted surveillance and numbers of animals examined and samples tested. Provide details on the methods applied for monitoring the performance of the surveillance system including indicators.

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• c) 

  Livestock demographics and economics. What is the susceptible animal population by species and production systems in the country and the zone ? How many herds , flock s , etc., of each susceptible species are in the country? How are they distributed (e.g. herd density, etc.)? Provide tables and maps as appropriate.
• d) 

  Wildlife demographics. What susceptible species are present in the country and in the zone ? Provide estimates of population sizes and geographic distribution. What are the measures in place to prevent contact between domestic and wildlife susceptible species?
• e) 

  Slaughterhouses and markets. Where are the major livestock marketing or collection centres? What are the patterns of livestock movement within the country? How are the animals transported and handled during these transactions?
• 6. 

  FMD prevention
• a) 

  Coordination with neighbouring countries. Are there any relevant factors about the adjacent countries and zones that should be taken into account (e.g. size, distance from adjacent border to affected herds or animals )? Describe coordination, collaboration and information sharing activities with neighbouring countries and z ones .

If the FMD free zone with vaccination is situated in an FMD infected country or borders an infected country or zone , describe the animal health measures implemented to effectively prevent the introduction of the agent, taking into consideration physical or geographical barriers.

• b) 

  Import control procedures

From what countries or zones does the country authorize the import of susceptible animals or their products into a free zone ? What criteria are applied to approve such countries or zones ? What controls are applied on entry of such animals and products, and subsequent internal movement? What import conditions and test procedures are required? Are imported animals of susceptible species required to undergo a quarantine or isolation period? If so, for how long and where? Are import permits and health certificates required? What other procedures are used? Provide summary statistics of imports of susceptible animals and their products for the past 2 years, specifying the country or zone of origin, the species and the volume.

• i) 

  Provide a map with the number and location of ports, airports and land crossings. Is the official service responsible for import controls part of the official services, or is it an independent body? If it is an independent body, describe its management structure, staffing levels and resources, and its accountability to the central V eterinary Services . Describe the communication systems between the central authorities and the border inspection posts, and between border inspection posts.
• ii) 

  Provide a description on the methods used for the safe disposal of waste from international traffic, who is responsible and provide a summary, for the past 2 years, of the quantity disposed of.
• iii) 

  Describe the regulations, procedures, type and frequency of checks at the point of entry into the country and/or their final destination, concerning the import and follow-up of the following:

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Annex VI (contd)

• - 

  animals ,
• - 

  genetic material (semen and embryos),
• - 

  animal products,
• - 

  veterinary medicinal products (i.e. biologics).
• iv) 

  Describe the action available under legislation, and actually taken, when an illegal import is detected. Provide information on detected illegal imports.
• 7. 

  Control measures and contingency planning
• a) 

  Give details of any written guidelines, including contingency plans, available to the official services for dealing with suspected or confirmed outbreak s of FMD.
• b) 

  Is quarantine imposed on premises with suspicious cases , pending final diagnosis? What other procedures are followed regarding suspicious cases ?
• c) 

  In the event of an FMD outbreak :
• i) 

  indicate the sampling and testing procedures used to identify and confirm presence of the causative agent;
• ii) 

  describe the actions taken to control the disease situation in and around any holdings found to be infected with FMD;
• iii) 

  indicate the control and/or eradication procedures (e.g. vaccination, stamping-out, partial slaughter /vaccination, etc.) that would be taken. Include details on antigen and vaccine banks;
• iv) 

  describe the procedures used to confirm that an outbreak has been successfully controlled/eradicated, including any restrictions on restocking;
• v) 

  give details of any compensation payments made available to farmers, etc. when animals are slaughtered for disease control/eradication purposes and their prescribed timetable.
• 8. 

  Compliance with the Terrestrial Code

In addition to the documentary evidence that the provisions of Article 8.5.5. are properly implemented and supervised, the Delegate of the country must submit a declaration indicating:

• a) 

  that there has been no outbreak of FMD for the past 2 years,
• b) 

  no evidence of FMDV circulation for the past 12 months,
• c) 

  surveillance for FMD and FMDV circulation in accordance with Articles 8.5.40. to 8.5.46. is in operation.
• 9. 

  Recovery of status

Countries applying for recovery of status should comply with the provisions of Article 8.5.8. of the Terrestrial Code and provide detailed information as specified in sections 3.a), 3.b), 3.c) and 5.b) of this questionnaire. Information in relation to other sections need only be supplied if relevant.

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Annex VI (contd)

Article 1.6.4.

Questionnaire on rinderpest

RINDERPEST FREE COUNTRY

Report of a Member which applies for recognition of status, under Chapter 8.12. of the Terrestrial A nimal H ealth

Code (2009), as a rinderpest infection free country

Please address concisely the following topics. National regulations laws and Veterinary Administration directives may be referred to and annexed as appropriate in one of the OIE official languages.

• 1. 

  Introduction
• a) 

  Geographical factors. Provide a general description of the country including physical, geographical and other factors that are relevant to rinderpest dissemination, countries sharing common borders and other countries that although may not be adjacent share a link for the potential introduction of disease . Provide a map identifying the factors above.
• b) 

  Livestock industry. Provide a general description of the livestock industry in the country.
• 2. 

  Veterinary system
• a) 

  Legislation. Provide a list and summary of all relevant veterinary legislation in relation to rinderpest.
• b) 

  Veterinary Services. Provide documentation on the compliance of the V eterinary Service of the country with the provisions of Chapters 3.1. and 3.2. of the Terrestrial Code and 1.1.3. of the Terrestrial Manual and describe how the V eterinary Services supervise and control all rinderpest related activities. Provide maps and tables wherever possible.
• c) 

  Role of farmers, industry and other relevant groups in rinderpest surveillance and control (include a description of training and awareness programmes on rinderpest).
• d) 

  Role of private veterinary profession in rinderpest surveillance and control.
• 3. 

  Rinderpest eradication
• a) 

  History. Provide a description of the rinderpest history in the country, date of first detection, origin of infection , date of eradication (date of last case ), lineage(s) present.
• b) 

  Strategy. Describe how rinderpest was controlled and eradicated (e.g. stamping-out, modified stamping-out, zoning), provide timeframe for eradication.
• c) 

  Vaccines and vaccination. Was rinderpest vaccine ever used? If so, when was the last vaccination carried out? What species were vaccinated? Has heterologous vaccine been used in cattle, buffalo or yak?

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• d) 

  Legislation, organisation and implementation of the rinderpest eradication campaign. Provide a description of the organizational structure at the different levels. Indicate if detailed operational guidelines exist and give a brief summary.
• e) 

  Animal identification and movement control. Are susceptible animals identified (individually or at a group level)? Provide a description of the methods of animal identification, herd registration and traceability. How are animal movements controlled in the country? Provide evidence on the effectiveness of animal identification and movement controls. Please provide information on pastoralism, transhumance and related paths of movement.
• 4. 

  Rinderpest diagnosis

Provide evidence that a system is in place for the rapid confirmation of a suspected outbreak i.e. that the provisions in Chapters 1.1.2., 1.1.3. and 2.1.15. of the Terrestrial Manual are applied. In particular, the following points should be addressed:

• a) 

  Is rinderpest laboratory diagnosis carried out in the country? If so, provide a list of approved laboratories. If not, provide the name(s) of and the arrangements with the laboratory(ies) samples are sent to, the follow up procedures and the time frame for obtaining results.
• b) 

  Provide an overview of the rinderpest approved laboratories, in particular to address the following points:
• i) 

  Procedures for the official accreditation of laboratories. Give details of internal quality management systems, e.g. Good Laboratory Practice, ISO, etc. that exist in, or planned for, the laboratory system.
• ii) 

  Give details of participation in inter-laboratory validation tests (ring tests).
• iii) 

  Is live virus handled?
• iv) 

  Biosecurity measures applied.
• v) 

  Details of the type of tests undertaken.
• 5. 

  Rinderpest surveillance

Provide documentary evidence that surveillance for rinderpest in the country complies with the provisions of Articles 8.12.20. to 8.12.27. of the Terrestrial Code and Chapter 2.1.15. of the Terrestrial Manual . In particular, the following points should be addressed:

• a) 

  Clinical suspicion. What are the criteria for raising a suspicion of rinderpest? What is the procedure to notify (by whom and to whom) and what penalties are involved for failure to report? Provide a summary table indicating, for the past 2 years, the number of suspect cases , the number of samples tested for rinderpest virus, species, type of sample, testing method(s) and results (including differential diagnosis). In particular, provide evidence of compliance with the provisions of Articles 8.12.20. to 8.12.27. of the Terrestrial Code .

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Annex VI (contd)

• b) 

  Serological surveillance. Are serological surveys conducted? If so, provide detailed information on the survey design in accordance with Articles 8.12.20. to 8.12.27. of the Terrestrial Code ¹. Are wildlife susceptible species included in serological surveys? If not, explain the rationale. Provide a summary table indicating, for the past 2 years, the number of samples tested for rinderpest virus, species, type of sample, testing method(s) and results (including differential diagnosis). Provide details on follow-up actions taken on all suspicious and positive results. Provide criteria for selection of populations for targeted surveillance and numbers of animals examined and samples tested. Provide details on the methods applied for monitoring the performance of the surveillance system including indicators.
• c) 

  Livestock demographics and economics. What is the susceptible animal population by species and production systems? How many herds , flock s , etc., of each susceptible species are in the country? How are they distributed (e.g. herd density, etc.)? Provide tables and maps as appropriate.
• d) 

  Wildlife demographics. What susceptible species are present in the country? Provide estimates of population sizes and geographic distribution. What are the measures in place to prevent contact between domestic and wildlife susceptible species?
• e) 

  Slaughterhouses and markets. Where are the major livestock marketing or collection centres? What are the patterns of livestock movement within the country? How are the animals transported and handled during these transactions.
• 6. 

  Rinderpest prevention
• a) 

  Coordination with neighbouring countries. Are there any relevant factors about the adjacent countries that should be taken into account (e.g. size, distance from adjacent border to affected herds or animals )? Describe coordination, collaboration and information sharing activities with neighbouring countries.
• b) 

  Import control procedures

From what countries or zones does the country authorize the import of susceptible animals or their products? What criteria are applied to approve such countries or zones ? What controls are applied on entry of such animals and products, and subsequent internal movement? What import conditions and test procedures are required? Are imported animals of susceptible species required to undergo a quarantine or isolation period? If so, for how long and where? Are import permits and health certificates required? What other procedures are used? Provide summary statistics of imports of susceptible animals and their products for the past 2 years, specifying country or zone of origin, species and volume.

• i) 

  Provide a map with the number and location of ports, airports and land crossings. Is the official service responsible for import controls part of the official services, or is it an independent body? If it is an independent body, describe its management structure, staffing levels and resources, and its accountability to the central V eterinary Services . Describe the communication systems between the central authorities and the border inspection posts, and between border inspection posts.
• ii) 

  Describe the regulations, procedures, type and frequency of checks at the point of entry into the country and/or their final destination, concerning the import and follow-up of the following:

17701/09                                                                                             LT/hl                          87

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Annex VI (contd)

• - 

  animals ,
• - 

  genetic material (semen and embryos),
• - 

  animal products,
• - 

  veterinary medicinal products (i.e. biologics).
• iii) 

  Describe the action available under legislation, and actually taken, when an illegal import is detected. Provide information on detected illegal imports.
• 7. 

  Control measures and contingency planning
• a) 

  Give details of any written guidelines, including contingency plans, available to the official services for dealing with suspected or confirmed outbreak s of rinderpest.
• b) 

  Is quarantine imposed on premises with suspicious cases , pending final diagnosis? What other procedures are followed regarding suspicious ca ses ?
• c) 

  In the event of a rinderpest outbreak :
• i) 

  indicate the sampling and testing procedures used to identify and confirm presence of the causative agent;
• ii) 

  describe the actions taken to control the disease situation in and around any holdings found to be infected with rinderpest;
• iii) 

  indicate the control and/or eradication procedures (e.g. vaccination, stamping-out, partial slaughter /vaccination, etc.) that would be taken;
• iv) 

  describe the procedures used to confirm that an outbreak has been successfully controlled/eradicated, including any restrictions on restocking;
• v) 

  give details of any compensation payments made available to farmers, etc. when animals are slaughtered for disease control/eradication purposes and their prescribed timetable.
• 8. 

  Compliance with the Terrestrial Code

The Delegate of the country must submit documentary evidence that the provisions of Article 8.12.2. or point 1 of Article 1.4.6. (historical freedom) of the Terrestrial Code have been properly implemented and supervised.

• 9. 

  Recovery of status

Countries applying for recovery of status should comply with the provisions of Article 8.12.3. of the Terrestrial Code and provide detailed information as specified in sections 3.a), 3.b), 3.c) and 5.b) of this questionnaire. Information in relation to other sections need only be supplied if relevant.

Article 1.6.5. Questionnaire on contagious bovine pleuropneumonia

CBPP FREE COUNTRY

Report of a Member which applies for recognition of status, under Chapter 11.9. of the Terrestrial A nimal H ealth

Code (2009), as a CBPP free country

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Annex VI (contd)

Please address concisely the following topics. National regulations laws and Veterinary Administration directives may be referred to and annexed as appropriate in one of the OIE official languages.

• 1. 

  Introduction
• a) 

  Geographical factors. Provide a general description of the country including physical, geographical and other factors that are relevant to CBPP dissemination, countries sharing common borders and other countries that although may not be adjacent share a link for the potential introduction of disease . Provide a map identifying the factors above.
• b) 

  Livestock industry. Provide a general description of the livestock industry in the country.
• 2. 

  Veterinary system
• a) 

  Legislation. Provide a list and summary of all relevant veterinary legislation in relation to CBPP.
• b) 

  Veterinary Services. Provide documentation on the compliance of the V eterinary Service of the country with the provisions of Chapters 3.1. and 3.2. of the Terrestrial Code and 1.1.3. of the Terrestrial Manual and describe how the V eterinary Services supervise and control all CBPP related activities. Provide maps and tables wherever possible.
• c) 

  Role of farmers, industry and other relevant groups in CBPP surveillance and control (include a description of training and awareness programmes on CBPP).
• d) 

  Role of private veterinary profession in CBPP surveillance and control.
• 3. 

  CBPP eradication
• a) 

  History. Provide a description of the CBPP history in the country, date of first detection, origin of infection , date of eradication (date of last case ).
• b) 

  Strategy. Describe how CBPP was controlled and eradicated (e.g. stamping-out, modified stamping-out, zoning), and provide timeframe for eradication.
• c) 

  Vaccines and vaccination. Was CBPP vaccine ever used? If so, when was the last vaccination carried out?
• d) 

  Legislation, organisation and implementation of the CBPP eradication campaign. Provide a description of the organizational structure at the different levels. Indicate if detailed operational guidelines exist and give a brief summary.
• e) 

  Animal identification and movement control. Are susceptible animals identified (individually or at a group level)? Provide a description of the methods of animal identification, herd registration and traceability. How are animal movements controlled in the country? Provide evidence on the effectiveness of animal identification and movement controls. Please provide information on pastoralism, transhumance and the related paths of movement.
• 4. 

  CBPP diagnosis

Provide documentary evidence that the provisions in Chapters 1.1.2., 1.1.3. and 2.4.9. of the Terrestrial Manual are applied. In particular, the following points should be addressed:

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Annex VI (contd)

• a) 

  Is CBPP laboratory diagnosis carried out in the country? If so, provide a list of approved laboratories. If not, provide the name(s) of and the arrangements with the laboratory(ies) samples are sent to, the follow-up procedures and the time frame for obtaining results.
• b) 

  Provide an overview of the CBPP approved laboratories, in particular to address the following points:
• i) 

  Procedures for the official accreditation of laboratories. Give details of internal quality management systems, e.g. Good Laboratory Practice, ISO, etc. that exist in, or planned for, the laboratory system.
• ii) 

  Give details of participation in inter-laboratory validation tests (ring tests).
• iii) 

  Biosecurity measures applied.
• iv) 

  Details of the type of tests undertaken including procedures to isolate and identify M. mycoides subsp. mycoides SC as opposed to M. mycoides subsp. mycoides LC.
• 5. 

  CBPP surveillance

Provide documentary evidence that surveillance for CBPP in the country complies with the provisions of Articles 11.9.12. to 11.9.17. of the Terrestrial Code and Chapter 2.4.9. of the Terrestrial Manual . In particular, the following points should be addressed:

• a) 

  Clinical surveillance. What are the criteria for raising a suspicion of CBPP? What is the procedure to notify (by whom and to whom) and what penalties are involved for failure to report? Provide a summary table indicating, for the past 2 years, the number of suspect cases , the number of samples tested for CBPP agent, species, type of sample, testing method(s) and results (including differential diagnosis).
• b) 

  Slaughterhouses, slaughter slabs, abattoirs. What are the criteria for raising a suspicion of CBPP lesion? What is the procedure to notify (by whom and to whom)? Provide a summary table indicating, for the past 2 years, the number of suspect cases , the number of samples tested for CBPP agent, species, type of sample, testing method(s) and results (including differential diagnosis).
• c) 

  Provide details on training programmes for personnel involved in clinical and slaughter facilities surveillance , and the approaches used to increase community involvement in CBPP surveillance programmes.
• d) 

  For countries where a significant proportion of animals are not slaughtered in controlled abattoirs , what are the alternative surveillance measures applied to detect CBPP (e.g. active clinical surveilla nce programmes, laboratory follow-up).
• e) 

  Livestock demographics and economics. What is the susceptible animal population by species and production systems? How many herds of each susceptible species are in the country? How are they distributed (e.g. herd density, etc.)? Provide tables and maps as appropriate.
• f) 

  Slaughterhouses and markets. Where are the major livestock marketing or collection centres? What are the patterns of livestock movement within the country? How are the animals transported and handled during these transactions?

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Annex VI (contd)

• g) 

  Provide a description of the means employed during the 2 years preceding this application to rule out the presence of any Mmm SC strain in the susceptible population. Provide criteria for selection of populations for targeted surveillance and numbers of animals examined and samples tested. Provide details on the methods applied for monitoring the performance of the surveillance system including indicators.
• 6. 

  CBPP prevention
• a) 

  Coordination with neighbouring countries. Are there any relevant factors about the adjacent countries that should be taken into account (e.g. size, distance from adjacent border to affected herds or animals )? Describe coordination, collaboration and information sharing activities with neighbouring countries.
• b) 

  Import control procedures

From what countries or zones does the country authorize the import of susceptible animals ? What criteria are applied to approve such countries or zones ? What controls are applied on entry of such animals , and subsequent internal movement? What import conditions and test procedures are required? Are imported animals of susceptible species required to undergo a quarantine or isolation period? If so, for how long and where? Are import permits and health certificates required? What other procedures are used? Provide summary statistics of imports of susceptible animals for the past 2 years, specifying country or zone of origin, species and volume.

• i) 

  Provide a map with the number and location of ports, airports and land crossings. Is the official service responsible for import controls part of the official services, or is it an independent body? If it is an independent body, describe its management structure, staffing levels and resources, and its accountability to the central V eterinary Services . Describe the communication systems between the central authorities and the border inspection posts, and between border inspection posts.
• ii) 

  Describe the regulations, procedures, type and frequency of checks at the point of entry into the country and/or their final destination, concerning the import and follow-up of the following:

§ a ni mals ,

§ veterinary medicinal products (i.e. biologics).

• iii) 

  Describe the action available under legislation, and actually taken, when an illegal import is detected. Provide information on detected illegal imports.
• 7. 

  Control measures and contingency planning
• a) 

  Give details of any written guidelines, including contingency plans, available to the official services for dealing with suspected or confirmed outbreak s of CBPP.
• b) 

  Is quarantine imposed on premises with suspicious cases , pending final diagnosis? What other procedures are followed regarding suspicious cases ?
• c) 

  In the event of a CBPP outbreak :

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Annex VI (contd)

• i) 

  indicate the sampling and testing procedures used to identify and confirm presence of the causative agent;
• ii) 

  describe the actions taken to control the disease situation in and around any holdings found to be infected with CBPP;
• iii) 

  indicate the control and/or eradication procedures (e.g. vaccination, stamping-out, partial slaughter /vaccination, etc.) that would be taken;
• iv) 

  describe the procedures used to confirm that an outbreak has been successfully controlled/eradicated, including any restrictions on restocking;
• v) 

  give details of any compensation payments made available to farmers, etc. when animals are slaughtered for disease control/eradication purposes and their prescribed timetable.
• 8. 

  Compliance with the Terrestrial Code

In addition to the documentary evidence that the provisions of Article 11.9.3. are properly implemented and supervised, the Delegate of the country must submit a declaration indicating:

• a) 

  no clinical CBPP has been detected for at least 2 years;
• b) 

  no CBPP vaccines have been used for at least 2 years in any susceptible species;
• c) 

  the country operates both clinical surveillance and disease reporting systems for CBPP adequate to detect clinical disease if it were present;
• d) 

  all clinical and pathological evidence suggestive of CBPP is investigated by field and laboratory methods (including serological assessment) to refute a possible diagnosis of CBPP;
• e) 

  there are effective measures in force to prevent the re-introduction of the disease .
• 9. 

  Recovery of status

Countries applying for recovery of status should comply with the provisions of Article 11.9.4. of the Terrestrial Code and provide detailed information as specified in sections 3.a), 3.b), 3.c), 5.b), 5.c) and 5.d) of this questionnaire. Information in relation to other sections need only be supplied if relevant.

CBPP FREE ZONE

Report of a Member which applies for recognition of status, under Chapter 11.9. of the Terrestrial A nimal H ealth

Code (2009), as a CBPP free zone

Please address concisely the following topics. National regulations laws and Veterinary Administration directives may be referred to and annexed as appropriate in one of the OIE official languages.

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• 1. 

  Introduction
• a) 

  Geographical factors. Provide a general description of the country including physical, geographical and other factors that are relevant to CBPP dissemination, countries sharing common borders and other countries that although may not be adjacent share a link for the potential introduction of disease . Provide a map identifying the factors above. The boundaries of the zone must be clearly defined. Provide a digitalised, geo-referenced map with a precise text description of the geographical boundaries of the zone .
• b) 

  Livestock industry. Provide a general description of the livestock industry in the country.
• 2. 

  Veterinary system
• a) 

  Legislation. Provide a list and summary of all relevant veterinary legislation in relation to CBPP.
• b) 

  Veterinary Services. Provide documentation on the compliance of the V eterinary Service of the country with the provisions of Chapters 3.1. and 3.2. of the Terrestrial Code and 1.1.3. of the Terrestrial Manual and describe how the V eterinary Services supervise and control all CBPP related activities. Provide maps and tables wherever possible.
• c) 

  Role of farmers, industry and other relevant groups in CBPP surveillance and control (include a description of training and awareness programmes on CBPP).
• d) 

  Role of private veterinary profession in CBPP surveillance and control.
• 3. 

  CBPP eradication
• a) 

  History. Provide a description of the CBPP history in the zone , date of first detection, origin of infection , date of eradication (date of last case ).
• b) 

  Strategy. Describe how CBPP was controlled and eradicated in the zone (e.g. stamping-out, modified stamping-out, zoning) and provide timeframe for eradication.
• c) 

  Vaccines and vaccination. Was CBPP vaccine ever used? In the entire country? If vaccination was used, when was the last vaccination carried out? Where in the country?
• d) 

  Legislation, organisation and implementation of the CBPP eradication campaign. Provide a description of the organizational structure at the different levels. Indicate if detailed operational guidelines exist and give a brief summary.
• e) 

  Animal identification and movement control. Are susceptible animals identified (individually or at a group level)? Provide a description of the methods of animal identification, herd registration and traceability. How are animal movements controlled in the zone ? Provide evidence on the effectiveness of animal identification and movement controls. Please provide information on pastoralism, transhumance and the related paths of movement.
• 4. 

  CBPP diagnosis

Provide documentary evidence that the provisions in Chapters 1.1.2., 1.1.3. and 2.4.9. of the Terrestrial Manual are applied. In particular, the following points should be addressed:

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Annex VI (contd)

• a) 

  Is CBPP laboratory diagnosis carried out in the country? If so, provide a list of approved laboratories. If not, provide the name(s) of and the arrangements with the laboratory(ies) samples are sent to, the follow-up procedures and the time frame for obtaining results.
• b) 

  Provide an overview of the CBPP approved laboratories, in particular to address the following points:
• i) 

  Procedures for the official accreditation of laboratories. Give details of internal quality management systems, e.g. Good Laboratory Practice, ISO, etc. that exist in, or planned for, the laboratory system.
• ii) 

  Give details of participation in inter-laboratory validation tests (ring tests).
• iii) 

  Biosecurity measures applied.
• iv) 

  Details of the type of tests undertaken including procedures to isolate and identify M. mycoides subsp. mycoides SC as opposed to M. mycoides subsp. mycoides LC.
• 5. 

  CBPP surveillance

Provide documentary evidence that surveillance for CBPP in the country complies with the provisions of Articles 11.9.12. to 11.9.17. of the Terrestrial Code and Chapter 2.4.9. of the Terrestrial Manual . In particular, the following points should be addressed:

• a) 

  Clinical surveillance. What are the criteria for raising a suspicion of CBPP? What is the procedure to notify (by whom and to whom) and what penalties are involved for failure to report? Provide a summary table indicating, for the past 2 years, the number of suspect cases , the number of samples tested for CBPP agent, species, type of sample, testing method(s) and results (including differential diagnosis).
• b) 

  Slaughterhouses, slaughter slabs, abattoirs. What are the criteria for raising a suspicion of CBPP lesion? What is the procedure to notify (by whom and to whom)? Provide a summary table indicating, for the past 2 years, the number of suspect cases , the number of samples tested for CBPP agent, species, type of sample, testing method(s) and results (including differential diagnosis).
• c) 

  Provide details on training programmes for personnel involved in clinical and slaughter facilities surveillance , and the approaches used to increase community involvement in CBPP surveillance programmes.
• d) 

  For countries where a significant proportion of animals in the zone are not slaughtered in controlled abattoirs , what are the alternative surveillance measures applied to detect CBPP (e.g. active clinical surveillance programme, laboratory follow-up).
• e) 

  Livestock demographics and economics. What is the susceptible animal population by species and production systems? How many herds of each susceptible species are in the zone ? How are they distributed (e.g. herd density, etc.)? Provide tables and maps as appropriate.
• f) 

  Slaughterhouses and mark ets . Where are the major livestock marketing or collection centres? What are the patterns of livestock movement within the country and the zone ? How are the animals transported and handled during these transactions?

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Annex VI (contd)

• g) 

  Provide a description of the means employed during the 2 years preceding this application to rule out the presence of any Mmm SC strain in the susceptible population of the zone . Provide criteria for selection of populations for targeted surveillance and numbers of animals examined and samples tested. Provide details on the methods applied for monitoring the performance of the surveillance system including indicators.
• 6. 

  CBPP prevention
• a) 

  Coordination with neighbouring countries and zones . Are there any relevant factors about the adjacent countries and zones that should be taken into account (e.g. size, distance from adjacent border to affected herds or animals )? Describe coordination, collaboration and information sharing activities with neighbouring countries and zones . If the CBPP free zone is situated in a CBPP infected country or borders an infected country or zone , describe the animal health measures implemented to effectively prevent the introduction of the agent, taking into consideration physical or geographical barriers.
• b) 

  Import control procedures

From what countries or zones does the country authorize the import of susceptible animals ? What criteria are applied to approve such countries or zones ? What controls are applied on entry of such animals , and subsequent internal movement? What import conditions and test procedures are required? Are imported animals of susceptible species required to undergo a quarantine or isolation period? If so, for how long and where? Are import permits and health certificates required? What other procedures are used? Provide summary statistics of imports of susceptible animals for the past 2 years, specifying country or zone of origin, species and volume.

• i) 

  Provide a map with the number and location of ports, airports and land crossings. Is the official service responsible for import controls part of the official services, or is it an independent body? If it is an independent body, describe its management structure, staffing levels and resources, and its accountability to the central V eterinary Services . Describe the communication systems between the central authorities and the border inspection posts, and between border inspection posts.
• ii) 

  Describe the regulations, procedures, type and frequency of checks at the point of entry into the zone and/or their final destination, concerning the import and follow-up of the following:

§ a ni mals ,

§ veterinary medicinal products (i.e. biologics).

• iii) 

  Describe the action available under legislation, and actually taken, when an illegal import is detected. Provide information on detected illegal imports.
• 7. 

  Control measures and contingency planning
• a) 

  Give details of any written guidelines, including contingency plans, available to the official services for dealing with suspected or confirmed outbreak s of CBPP.
• b) 

  Is quarantine imposed on premises with suspicious cases , pending final diagnosis? What other procedures are followed regarding suspicious cases ?

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Annex VI (contd)

• c) 

  In the event of a CBPP outbreak :
• i) 

  indicate the sampling and testing procedures used to identify and confirm presence of the causative agent;
• ii) 

  describe the actions taken to control the disease situation in and around any holdings found to be infected with CBPP;
• iii) 

  indicate the control and/or eradication procedures (e.g. vaccination, stamping-out, partial slaughter /vaccination, etc.) that would be taken;
• iv) 

  describe the procedures used to confirm that an outbreak has been successfully controlled/eradicated, including any restrictions on restocking;
• v) 

  give details of any compensation payments made available to farmers, etc. when animals are slaughtered for disease control/eradication purposes.
• 8. 

  Compliance with the Terrestrial Code

In addition to the documentary evidence that the provisions of Article 11.9.3. are properly implemented and supervised, the Delegate of the country must submit a declaration indicating that in the zone :

• a) 

  no clinical CBPP has been detected for at least 2 years;
• b) 

  no CBPP vaccines have been used for at least 2 years in any susceptible species;
• c) 

  the country operates both clinical surveillance and disease reporting systems for CBPP adequate to detect clinical disease if it were present in the zone ;
• d) 

  all clinical and pathological suggestive of CBPP is investigated by field and laboratory methods (including serological assessment) to refute a possible diagnosis of CBPP;
• e) 

  there are effective measures in force to prevent the re-introduction of the disease .
• 9. 

  Recovery of status

Countries applying for recovery of status should comply with the provisions of Article 11.9.4. of the Terrestrial Code and provide detailed information as specified in sections 3.a), 3.b), 3.c), 5.b), 5.c) and 5.d) of this questionnaire. Information in relation to other sections need only be supplied if relevant.

• 1. 

  Accounts of the ages for eruption of the incisor teeth vary markedly and are clearly dependent on species, breed, nutritional status and nature of the feed. Therefore, for the purposes of serosurveillance, it should be noted that a) cattle having only one pair of erupted permanent central incisor teeth are aged between 21 and 36 months (Asian buffalos 24-48 months) and b) cattle having only two pairs of erupted permanent central incisor teeth are aged between 30 and 48 months (Asian buffalos 48-60 months).

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Annex VII

CH AP TE R 2.1

IMPORT RISK ANALYSIS

EU Comments

The EU can support the proposed change.

Article 2.1.1.

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 risk s 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 informal procedure for dispute mediation.

Chapter 2.2. provides recommendations 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).

F ig. 1. The four components of risk analysis

The risk assessment is the component of the analysis which estimates the risk s associated with a hazard . Risk assessments may be qualitative or quantitative. For many diseases , particularly for those diseases listed in this T errestrial Code where there are well developed internationally agreed standards, there is broad agreement concerning the likely risk s . 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.

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The process of import risk analysis usually needs to take into consideration the results of an evaluation of V eterinary Services , zoning, compartmentalisation and surveillance systems in place for monitoring of animal health in the ex porting country . These are described in separate Chapters in the T errestrial Code .

Article 2.1.2. 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.

H azard 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 V eterinary 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 ex porting country .

An importing country may decide to permit the importation using the appropriate sanitary standards recommended in the Terrestrial Code , thus eliminating the need for a risk assessment .

Article 2.1.3. Principles of risk assessment

• 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. Although quantitative assessment is recognised as being able to provide deeper insights into a particular problem, qualitative methods may be more relevant when available data are limited.
• 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.

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Annex VII (contd)

Article 2.1.4.

Risk assessment steps

• 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 V eterinary Services , surveillance and control programmes and zoning and compartmentalisation systems of the ex porting 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 does not need to continue.

• 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:

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• 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 risk s 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.

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For a quantitative assessment, the final outputs may include:

• - 

  estimated numbers of herds , flock s , 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 2.1.5. Principles of risk management

• 1. 

  Risk management is the process of deciding upon and implementing measures to achieve the Member's appropriate level of protection, whilst at the same time ensuring that negative effects on trade are minimized. The objective is to manage risk appropriately to ensure that a balance is achieved between a country's desire to minimize the likelihood or frequency of disease incursions and their consequences and its desire to import commodities and fulfil its obligations under interna tiona l 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 2.1.6. Risk management components

• 1. 

  Risk evaluation - the process of comparing the risk estimated in the risk assessment with the Member's appropriate level of protection.
• 2. 

  Option evaluation - the process of identifying, evaluating the efficacy and feasibility of, and selecting measures to reduce the risk associated with an importation in order to bring it into line with the Members 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.

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Article 2.1.7.

Principles of risk communication

• 1. 

  Risk communication is the process by which information and opinions regarding hazards and risk s 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 ex porting 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.

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Annex VIII

CH AP TE R 3.1. VETERINARY SERVICES

EU Comments

The EU can support the proposed changes.

Article 3.1.1.

The quality of the V eterinary Services depends on a set of factors, which include fundamental principles of an ethical, organisational, legislative and technical nature. The V eterinary 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 V eterinary Services of a Member is important to the establishment and maintenance of confidence in its international veterinary certificates by the V eterinary Services of other Members.

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 V eterinary Services , or by an authority or agency on behalf of the V eterinary Services . In all cases, the V eterinary Services retain ultimate responsibility for the application of these principles.

These fundamental principles are presented in Article 3.1.2. Other factors affecting quality are described in Volume 1 of the Terrestrial Code (notification, principles of certification, etc.).

The quality of V eterinary Services, including veterinary legislation, can be measured through an evaluation, whose general principles are described in Article 3.1.3. and in Article 3.1.4.

Recommendations on the evaluation of V eterinary Services, including legislation, are described in Chapter 3.2.

EU comment

EU suggest to add the word "veterinary" before the word "legislation" to be consistent.

A procedure for evaluating V eterinary Services by OIE experts, on a voluntary basis, is described in Article 3.1.5.

Article 3.1.2. Fundamental principles of quality

The V eterinary Services shall comply with the following principles to ensure the quality of their activities:

• 1. 

  Professional judgement

The personnel of V eterinary Services should have the relevant qualifications, scientific expertise and experience to give them the competence to make sound professional judgements.

• 2. 

  Independence

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Care should be taken to ensure that V eterinary Services ' personnel are free from any commercial, financial, hierarchical, political or other pressures which might affect their judgement or decisions.

• 3. 

  Impartiality

The V eterinary 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 V eterinary 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 V eterinary Services should at all times act in an objective, transparent and non-discriminatory manner.

6.    Veterinary legislation

Veterinary legislation is a fundamental element of quality as it supports good governance and provides the legal framework for all key activities of the veterinary services.

Legislation should be suitably flexible to allow for judgements of equivalence and efficient responses to changing situations. In particular, it 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.

67. General organisation

The V eterinary 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 V eterinary Services when they are in charge of veterinary public health activities.

The V eterinary 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 the 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 V eterinary Services should define and document the responsibilities and structure of the organisation (in particular the chain of command) in charge of issuing internationa l veterina ry certifica tes .

Each position within the V eterinary 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.

78. Quality policy

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The V eterinary 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 recommendations for the quality and evaluation of V eterinary Services propose a suitable reference system, which should be used if a Member choose to adopt a quality system.

89. Procedures and standards

The V eterinary 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 outbreak s ;
• 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 V eterinary Services should comply with these standards when applying animal health measures and when issuing interna tional veterinary certificates .

910. Information, complaints and appeals

The V eterinary A uthority should undertake to reply to legitimate requests from V eterinary A uthorities of other Members or any other authority, in particular ensuring that any requests for information, complaints or appeals that they may present are dealt with in a timely manner.

A record should be maintained of all complaints and appeals and of the relevant action taken by the V eteri na ry S ervi ces .

1011. Documentation

The V eterinary Services should have at their disposal a reliable and up-to-date documentation system suited to their activities.

1112. Self-evaluation

The V eterinary Services should undertake periodical self-evaluation especially by documenting achievements against goals, and demonstrating the efficiency of their organisational components and resource adequacy.

A procedure for evaluating V eterinary Services by OIE experts, on a voluntary basis, is described in Article 3.1.5.

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1213. Communication

V eterinary Services should have effective internal and external systems of communication covering administrative and technical staff and parties affected by their activities.

1314. Human and financial resources

Responsible authorities should ensure that adequate resources are made available to implement effectively the above activities.

Article 3.1.3.

For the purposes of the Terrestrial Code , every Member should recognise the right of another Member to undertake, or request it to undertake, an evaluation of its V eterinary Services where the initiating Member 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 V eterinary Services should be conducted having regard to the OIE recommendations on the evaluation of V eterinary Services presented in Chapter 3.2.

A Member has the right to expect that the evaluation of its V eterinary Services will be conducted in an objective manner. A Member undertaking evaluation should be able to justify any measure taken as a consequence of its evaluation.

Article 3.1.4.

A Member which intends to conduct an evaluation of another Member's V eterinary 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 V eterinary Services by another Member, and following bilateral agreement of the evaluation process and criteria, a Member 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 3.1.1. and in Article 3.1.2. It should also take into consideration the specific circumstances regarding quality, as described in Article 3.1.1., prevailing in the countries concerned.

The outcome of the evaluation conducted by a Member 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 which has undergone the evaluation. The evaluation report should detail any findings which affect trade prospects. The Member which conducts the evaluation should clarify in detail any points of the evaluation on request.

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In the event of a dispute between two Members over the conduct or the conclusions of the evaluation of the V eterinary Services , the matter should be dealt with having regard to the procedures set out in Article 5.3.8.

Article 3.1.5. Evaluation facilitated by OIE experts under the auspices of the OIE

The OIE has established procedures for the evaluation of the V eterinary Services of a Member, upon request by the Member.

The World Assembly of OIE Delegates endorses a list of approved experts to facilitate the evaluation process.

Under these procedures, the Director General of the OIE recommends an expert(s) from that list.

The expert(s) facilitate(s) the evaluation of the V eterinary Services of the Member based on the provisions in Chapter 3.2., using the OIE Tool for the E valuation of Performance of V eterinary Services (OIE PV S Tool ).

The expert(s) produce(s) a report in consultation with the V eterinary Services of the Member.

The report is submitted to the Director General of the OIE and, with the consent of the Member, published by the OIE.

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CHAPTER 3.2.

EVALUATION OF VETERINARY SERVICES

EU Comments

The EU can support the proposed changes.

Article 3.2.1. General considerations

• 1. 

  Evaluation of V eterinary 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 3.1.

• 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 recommendations which can be practically applied to the evaluation of V eterinary Services . These are relevant for evaluation of the V eterinary Services of one country by those of another country for the purposes of risk analysis in international trade . The recommendations are also applicable for evaluation by a country of its o wn V eterinary Services – the process known as self-evaluation – and for periodic re-evaluation. These recommendations should be used by OIE experts when facilitating an evaluation under the auspices of the OIE, following a request of a Member. In applying these recommendations on the evaluation, the OIE Tool for the E valuation of Performance of V eterinary Services (OIE PV S Tool ) should be used.

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 V eterinary Services of the ex porting 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 o wn V eterinary 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 V eterinary 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 of resources, management capability, legislative and administrative infrastructures, independence in the exercise of official functions and history of performance history, including disease reporting.
• 5. 

  Good governance is the key to cCompetence, and integrity and are qualities on which others base their confidence in individuals or organisations. Mutual confidence between relevant official V eterinary 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 ex porting country than at the importing country .

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• 6. 

  Although quantitative data can be provided on V eterinary 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 V eterinary Services . Evaluation should take into consideration any quality systems used by V eteri na ry S ervi ces .
• 7. 

  An importing country has a right of assurance that information on sanitary/zoosanitary situations provided by the V eterinary Services of an ex porting country is objective, meaningful and correct. Furthermore, the V eterinary Services of the importing country are entitled to expect validity in the veterinary certification of export.
• 8. 

  An ex porting 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 V eterinary Services , an evaluation of that body should be carried out to ensure that the registration/licensing of veterinarians and authorisation of veterinary para-professi onals is included.

Article 3.2.2. Scope

• 1. 

  In the evaluation of V eterinary Services , the following items may be considered, depending on the purpose of the evaluation:

o   organisation, structure and authority of the V eterina ry Services ;

o   human resources;

o   material (including financial) resources;

o   veterinary legislation and functional capabilities and legislative support;

o   animal health and veterinary public health controls;

o   formal quality systems including quality policy;

o   performance assessment and audit programmes;

o   participation in OIE activities and compliance with OIE Members’ obligations.

• 2. 

  To complement the evaluation of V eterinary Services , the legislative framework, organisational structure and functioning of the veterinary statutory body should also be considered.
• 3. 

  Article 3.2.14. outlines appropriate information requirements for:

o self-evaluation by the V eterinary A uthority which perceives a need to prepare information for national or international purposes;

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o evaluation by a prospective or actual importing country of the V eterinary Services of a prospective or actual exporting count ry ;

o verification or re-verification of an evaluation in the course of a visit to the exporting country by the i mporting count ry ;

o evaluation by third parties such as OIE PVS experts or regional organisations.

Article 3.2.3. Evaluation criteria for the organisational structure of the Veterinary Services

• 1. 

  A key element in the evaluation is the study of the organisation and structure of the official V eterinary Services . The V eterinary 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 V eterinary 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 V eterinary 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 V eterinary 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 V eterinary A uthority alone speaks for the country as far as official international dialogue is concerned. This is also particularly important to cases where zoning and compartmentalisation are being applied. The responsibilities of the V eterinary A uthority should be made clear in the process of evaluation of V eterinary Servi ce s .
• 6. 

  The V eterinary A uthority is defined in the Glossary of the Terrestrial Code . As some countries have some relevant roles of the V eterinary A uthority 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 V eterinary A uthority 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 V eterinary A uthority has 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 organisational and functional standards that apply to the V eterinary A uthority should also apply to the service providers.

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Article 3.2.4.

Evaluation criteria for quality systems

• 1. 

  The V eterinary 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 V eterinary Services other internationally recognised quality standards, the V eterinary 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 V eterinary 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 3.2.5.

Evaluation criteria for human resources

• 1. 

  The V eterinary 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 V eterinary 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 V eterinary 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 V eterinary 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 V eterinary 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 V eterinary 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.

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Article 3.2.6. Evaluation criteria for material resources

• 1. 

  Financial

Actual yearly budgetary information regarding the V eterinary Services should be available and should include the details set out in the model questionnaire outlined in Article 3.2.14. 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 nongovernment sources of revenue available to veterina rians in their official responsibilities.

• 2. 

  Administrative
• a. 

  Accommodation

The V eterinary Services should be accommodated in premises suitable for efficient performance of their functions. The component parts of the V eterinary 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 V eterinary 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 V eterinary 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 V eterinary 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 V eterinary A uthority , to permit reporting of changes in national disease status consistent with OIE recommendations and to allow bilateral contact on urgent matters with counterpart V eterinary A uthorities in trading-partner countries.

• c. 

  Transport systems

The availability of sufficient reliable transport facilities is essential for the performance of many functions of V eterinary Services . This applies particularly to the field services components of animal health activities (e.g. emergency response visits). Otherwise, the V eterinary 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.

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• 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 V eterinary Services , which would include official governmental laboratories and other laboratories accredited by the V eterinary 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 V eterinary 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 3.2.7. Legislation and fFunctional capabilities and legislative support

• 1. 

  Animal health and veterinary public health

The V eterinary A uthority should be able to demonstrate that it has the capacity, supported by appropriate legislation, to exercise control over all animal health matters. These controls should include, where appropriate, compulsory notification of prescribed animal diseases, inspection, movement controls through systems which provide adequate traceability, registration of facilities, quarantine of infected premises/areas, testing, treatment, destruction of infected animals or contaminated materials, controls over the use of veterinary medicines, etc. The scope of the legislative controls should include domestic animals and their reproductive material, animal products, wildlife as it relates to the transmission of diseases to humans and domestic animals , and other products subject to veterinary inspection. Arrangements should exist for cooperation with the V eterinary A uthorities of the neighbouring countries for the control of animal diseases in border areas and for establishing linkages to recognise and regulate transboundary activities. Information on the veterinary public health legislation covering the production of products of animal origin for national consumption may be also considered in the evaluation.

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• 2. 

  Export/import inspection

The V eterinary A uthority should have appropriate legislation and adequate capabilities to prescribe the methods for control and to exercise systematic control over the import and export processes of animals and animal products in so far as this control relates to sanitary and zoosanitary matters. The evaluation should also involve the consideration of administrative instructions to ensure the enforcement of importing country requirements during the pre-export period.

In the context of production for export of foodstuffs of animal origin, the V eterinary A uthority should demonstrate that comprehensive legislative provisions are available for the oversight by the relevant authorities of the hygienic process and to support official inspection systems of these commodities which function to standards consistent with or equivalent to relevant Codex Alimentarius and OIE standards.

Control systems should be in place which permit the exporting V eterinary A uthority to approve export premises. The V eterinary Services should also be able to conduct testing and treatment as well as to exercise controls over the movement, handling and storage of exports and to make inspections at any stage of the export process. The product scope of this export legislation should include, inter alia , animals and animal products (including animal semen, ova and embryos), and animal feedstuffs.

The V eterinary A uthority should be able to demonstrate that they have adequate capabilities and legislative support for zoosanitary control of imports and transit of animals , animal products and other materials which may introduce animal diseases . This could be necessary to support claims by the V eterinary Services that the animal health status of the country is suitably stable, and that cross-contamination of exports from imports of unknown or less favourable zoosanitary status is unlikely. The same considerations should apply in respect of veterinary control of public health. The V eterinary Services should be able to demonstrate that there is no conflict of interest when certifying veterinarians are performing official duties.

Legislation should also provide the right to deny and/or withdraw official certification. Penalty provisions applying to malpractice on the part of certifying officials should be included.

The V eterinary Services should demonstrate that they are capable of providing accurate and valid certification for exports of animals and animal products, based on Chapters 5.1. and 5.2. of the Terrestrial Code . They should have appropriately organised procedures which ensure that sanitary/animal health certificates are issued by efficient and secure methods. The documentation control system should be able to correlate reliably the certification details with the relevant export consignments and with any inspections to which the consignments were subjected.

Security in the export certification process, including electronic documentation transfer, is important. A system of independent compliance review is desirable, to safeguard against fraud in certification by 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.

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Article 3.2.8.

Animal health controls

• 1. 

  Animal health status

An updated assessment of the present animal disease status of a country is an important and necessary procedure. For this undertaking, studies of the OIE publications such as World A nimal H ealth , the Bulletin and Disease I nformation must be fundamental reference points. The evaluation should consider the recent history of the compliance of the country with its obligations regarding international notification of animal diseases . In the case of an OIE Member, failure to provide the necessary animal health reports consistent with OIE requirements will detract from the overall outcome of the evaluation of the country.

An exporting country should be able to provide further, detailed elaboration of any elements of its animal disease status as reported to the OIE. This additional information will have particular importance in the case of animal diseases which are foreign to or strictly controlled in the importing country or region. The ability of the V eterinary Services to substantiate elements of their animal disease status reports with surveillance data, results of monitoring programmes and details of disease history is highly relevant to the evaluation. In the case of evaluation of the V eterinary Services of an ex porting country for international trade purposes, an importing country should be able to demonstrate the reasonableness of its request and expectations in this process.

• 2. 

  Animal health control

Details of current animal disease control programmes should be considered in the evaluation. These programmes would include epidemiological surveillance, official government-administered or officially-endorsed, industry-administered control or eradication programmes for specific diseases or disease complexes, and animal disease emergency preparedness. Details should include enabling legislation, programme plans for epidemiological surveillance and animal disease emergency responses, quarantine arrangements for infected and exposed animals or herds , compensation provisions for animal owners affected by disease control measures, training programmes, physical and other barriers between the free country or zone and those infected, incidence and prevalence data, resource commitments, interim results and programme review reports.

• 3. 

  National animal disease reporting systems

The presence of a functional animal disease reporting system which covers all agricultural regions of the country and all veterinary administrative control areas should be demonstrated.

An acceptable variation would be the application of this principle to specific zones of the country. In this case also, the animal disease reporting system should cover each of these zones. Other factors should come to bear on this situation, e.g. the ability to satisfy trading partners that sound animal health controls exist to prevent the introduction of disease or export products from regions of lesser veterinary control.

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Article 3.2.9. Veterinary public health controls

• 1. 

  Food hygiene

The V eterinary A uthority should be able to demonstrate effective responsibility for the veterinary public health programmes relating to the production and processing of animal products. If the V eterinary A uthority does 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 V eterinary A uthority 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 V eterinary Services , there should be appropriately qualified personnel whose responsibilities include the monitoring and control of zoonotic diseases and, where appropriate, liaison with medical authorities.

• 3. 

  Chemical residue testing programmes

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 V eterinary Services , there should be appropriate provision to ensure that the results of such programmes are made available to the V eterinary Services for assessment. This process should be consistent with the standards set by the Codex Alimentarius Commission or with alternative requirements set by the importing country where the latter are scientifically justified.

• 4. 

  Veterinary medicines

It should be acknowledged that primary control over veterinary medicinal products may not rest with the V eterinary A uthority in some countries, owing to differences between governments in the division of legislative responsibilities. However, for the purpose of evaluation, the V eterinary A uthority 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 V eterinary 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 Commission or with alternative requirements set by the importing country where the latter are scientifically justified.

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• 5. 

  Integration between animal health controls and veterinary public health

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.

V eterinary 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 3.2.10. Performance assessment and audit programmes

• 1. 

  Strategic plans

The objectives and priorities of the V eterinary 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.

V eterinary 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 V eterinary 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 V eterinary Services and of the corporate body itself. The existence of such a body can be important to the establishment of international confidence in the V eterinary Services .

An important feature when demonstrating the integrity of the V eterinary Services is their ability to take corrective action when miscertification, fraud or corruption has occurred.

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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 V eterinary 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 V eterinary 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 V eterinary Services or of particular functions or roles of the V eterinary 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 V eterinary Services or elements of their role or function, and details of any subsequent implementation of recommendations contained in these reports should be available. The

V eterinary 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 V eterinary 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

V eterinary 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 V eterinary 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 V eterinary Services .

• g. 

  Trade performance history

In the evaluation of the V eterinary 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.

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Article 3.2.11. Participation in OIE activities

Questions on a country's adherence to its obligations as a member of the OIE are relevant to an evaluation of the V eterinary Services of the country. Self-acknowledged inability or repeated failure of a Member 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 V eterinary Services and sanitary/zoosanitary status for evaluation purposes.

Article 3.2.12. Evaluation of veterinary statutory body

• 1. 

  Scope

In the evaluation of the veterinary statutory body , the following items may be considered, depending on the purpose of the evaluation:

• a. 

  objectives and functions;
• b. 

  legislative basis, autonomy and functional capacity;
• c. 

  the composition and representation of the body's membership;
• d. 

  accountability and transparency of decision-making;
• e. 

  sources and management of funding;
• f. 

  administration of training programmes and continuing professional development for veterinarians and veterinary para-professionals .
• 2. 

  Evaluation of objectives and functions

The veterinary statutory body should define its policy and objectives, including detailed descriptions of its powers and functions such as:

• a. 

  to regulate veterinarians and veterinary para-professionals through licensing and/or registration of such persons;
• b. 

  to determine the minimum standards of education (initial and continuing) required for degrees, diplomas and certificates entitling the holders thereof to be registered as veterina rians and veterinary para -professionals ;
• c. 

  to determine the standards of professional conduct of veterinarians and veterinary para-professionals and to ensure these standards are met.

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• 3. 

  Evaluation of legislative basis, autonomy and functional capacity

The veterinary statutory body should be able to demonstrate that it has the capacity, supported by appropriate legislation, to exercise and enforce control over all veterinarians and veterinary para-professionals . These controls should include, where appropriate, compulsory licensing and registration, minimum standards of education (initial and continuing) for the recognition of degrees, diplomas and certificates, setting standards of professional conduct and exercising control and the application of disciplinary procedures.

The veterinary statutory body should be able to demonstrate autonomy from undue political and commercial interests.

Where applicable, regional agreements for the recognition of degrees, diplomas and certificates for veteri na rians and veteri na ry pa ra-professi onals should be demonstrated.

• 4. 

  Evaluation of membership representation

Detailed descriptions should be available in respect of the membership of the veterinary statutory body and the method and duration of appointment of members. Such information includes:

• a. 

  veterinarians designated by the V eterinary A uthority , such as the Chief Veterinary Officer;
• b. 

  veterinarians elected by members registered by the veterina ry sta tutory body ;
• c. 

  veterinarians designated or nominated by the veterinary association(s);
• d. 

  representative(s) of veterinary para-professions;
• e. 

  representative(s) of veterinary academia;
• f. 

  representative(s) of other stakeholders from the private sector;
• g. 

  election procedures and duration of appointment; h.   qualification requirements for members.
• 5. 

  Evaluation of accountability and transparency of decision-making

Detailed information should be available on disciplinary procedures regarding the conducting of enquiries into professional misconduct, transparency of decision-making, publication of findings, sentences and mechanisms for appeal.

Additional information regarding the publication at regular intervals of activity reports, lists of registered or licensed persons including deletions and additions should also be taken into consideration.

• 6. 

  Evaluation of financial sources and financial management

Information regarding income and expenditure, including fee structure(s) for the licensing/registration of persons should be available.

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• 7. 

  Evaluation of training programmes and programmes for continuing professional development, for veterinarians and veterinary para-professionals

Descriptive summary of continuing professional development, training and education programmes should be provided, including descriptions of content, duration and participants; documented details of quality manuals and standards relating to Good Veterinary Practice should be provided.

Article 3.2.13.

• 1. 

  The V eterinary 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 V eterinary Services of an ex porting 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 3.2.14. The V eterinary 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 3.2.14.

This article outlines appropriate information requirements for the self-evaluation or evaluation of the V eterinary Services of a country.

• 1. 

  Organisation and structure of Veterinary Services
• a. 

  National Veterinary Authority

Organisational chart including numbers, positions and numbers of vacancies.

• b. 

  Sub-national components of the Veterinary Authority

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.

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• 2. 

  National information on human resources
• a. 

  Veterinarians
• i. 

  Total numbers of veterinarians registered/licensed by the V eterinary 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 V eterinary Services to perform official veterinary functions [Describe accreditation standards, responsibilities a nd/ or limitations applying to these private veterinarians. ] ;

§ other veteri na rians .

• iii. 

  Animal health:

Numbers associated with farm livestock sector on a majority time basis in a veterinary capacity, by geographical area [Show categories and numbers to differentiate staff involved in field service, laboratory, administration, import/ ex port and other functions, as a pplicable.] :

§ full time government veterinarians : national and sub-national;

§ part time government veterinarians : national and sub-national;

§ other veteri na rians .

• iv. 

  Veterinary public health:

Numbers employed in food inspection on a majority time basis, by commodity [Show categories and numbers to differentiate staff involved in inspection, laboratory and other functions, as a pplicable.] :

§    full time government veterinarians : national and sub-national;

§    part time government veterinarians : national and sub-national;

§    other veteri na rians .

• v. 

  Numbers of veterinarians relative to certain national indices:

§    per total human population;

§    per farm livestock population, by geographical area;

§    per livestock farming unit, by geographical area.

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• vi. 

  Veterinary education:

§ number of veterinary schools;

§ length of veterinary course (years);

§ international recognition of veterinary degree. vii. Veterinary professional associations.

• b. 

  Graduate personnel (non-veterinary)

Details to be provided by category (including biologists, biometricians, economists, engineers, lawyers, other science graduates and others) on numbers within the V eterinary A uthority and available to the V eteri na ry A uthority .

• c. 

  Veterinary para-professionals employed by the Veterinary Services i. Animal health:

§ Categories and numbers involved with farm livestock on a majority time basis:

§ by geographical area;

§ proportional to numbers of field Veterinary Officers in the V eterinary Services , by geographical area.

§ E ducation/training details.

• ii. 

  Veterinary public health:

§ Categories and numbers involved in food inspection on a majority time basis:

§ meat inspection: export meat establishments with an export function and domestic meat establishments (no export function);

§    dairy inspection;

§   other foods.

§   Numbers in import/export inspection.

§    E ducation/training details.

• d. 

  Support personnel

Numbers directly available to V eterinary 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.

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• 3. 

  Financial management information
• a. 

  Total budgetary allocations to the V eterinary A uthority for the current and past two fiscal years: i. for the national V eterinary A uthority ;
• ii. 

  for each of any sub-national components of the V eterinary A uthority ; 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 V eterinary Services .
• d. 

  Total allocation proportionate of national public sector budget. [This data may be necessary for comparative assessment with other countries which should tak e into account the contex ts 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 V eterinary Services (national and sub-national) in the country.

• b. 

  Communications

Summary of the forms of communication systems available to the V eterinary 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 V eterinary Services . In addition provide details of transport means available part-time.
• ii. 

  Details of annual funds available for maintenance and replacement of motor vehicles.

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ANNEX 1                                  DG B I                                        EN

Annex VIII (contd)

• 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 V eterinary Services .
• ii. 

  Numbers of veterinary diagnostic laboratories operating in the country:

§ government operated laboratories;

§ private laboratories accredited by government for the purposes of supporting official or officially-endorsed animal health control or public health testing and monitoring programmes and import/export testing.

• iii. 

  Descriptive summary of accreditation procedures and standards for private laboratories .
• iv. 

  Human and financial resources allocated to the government veterinary laboratories , including staff numbers, graduate and post-graduate qualifications and opportunities for further training.
• v. 

  List of diagnostic methodologies available against major diseases of farm livestock (including poultry ).
• vi. 

  Details of collaboration with external laboratories including international reference laboratories and details on numbers of samples submitted.
• vii. 

  Details of quality control and assessment (or validation) programmes operating within the veterinary laboratory service.
• viii. 

  Recent published reports of the official veterinary laboratory service which should include details of specimens received and foreign animal disease investigations made.
• ix. 

  Details of procedures for storage and retrieval of information on specimen submission and results.
• x. 

  Reports of independent reviews of the laboratory service conducted by government or private organisations (if available).
• xi. 

  Strategic and operational plans for the official veterinary laboratory service (if available).
• b. 

  Research laboratories (laboratories engaged primarily in research)
• i. 

  Numbers of veterinary research laboratories operating in the country:

§ government operated laboratories ;

§ private laboratories involved in full time research directly related to animal health and veterinary public health matters involving production animal species.

• ii. 

  Summary of human and financial resources allocated by government to veterinary research.
• iii. 

  Published programmes of future government sponsored veterinary research.
• iv. 

  Annual reports of the government research laboratories .