SEC(2008) 36

COMMISSION STAFF WORKING DOCUMENT

Written comments of the Community on the report of the September 2007 meeting of the Terrestrial Animal Health Standards Commission

EXPLANATORY MEMORANDUM

The OIE Terrestrial Animal Health Standards Commission (or "Terrestrial Code Commission", TCC) met at the OIE Headquarters in Paris in September 2007.

The meeting report has been sent to OIE Member Countries, and some modifications of the Terrestrial Code are proposed for comments.

The Community comments need to reach the OIE Headquarters by 8 February 2008 in order to be considered at the next meeting of the TCC, 10-14 March 2008.

The Commission therefore proposes to the Council to authorise the Commission to present to the OIE, as since 1995, the following written comments in the Annex.

The cover letter to be sent with our response is attached (Doc D1/EB/rd(2007) D/….).

In order to facilitate the examination of the comments of the Community, they have been incorporated in boxes into the OIE reports. In this context, the Community thanks the OIE for providing the electronic version of the Report.

[pic] | UNION EUROPÉENNE Deputy Director General |

Bruxelles, le

D1/EB/mjd (2007) D/413019

Object: Report of the September 2007 Meeting of the Terrestrial Animal Health Standard Commission – Comments of the European Community

Dear Bernard,

Please find attached as an annex to this letter the Community comments on the report of the meeting of Code Commission last September 2007.

We wish to express our admiration in front of the tremendous work of the TAHSC and the OIE in general in its task for better harmonised and useful standards and guidelines.

As usual the comments are inserted in boxes directly in the drafts, and propose deletions, addenda and/or alternative wording, with justification. In case these would not be agreed by the Code Commission at its next meeting in March 2008, it would be useful that we receive justified answers too, so that a real discussion takes place and the drafts can move on more easily.

We thank you for the continued excellent collaboration and trust you will find our comments constructive and useful.

Dr Vida Čadonič Špelič Paola Testori CoggiCVO Slovenia Deputy Director General

Enclosures: 1

Cc: All CVOs Member States, Croatia, Iceland, Norway, Turkey and Switzerland

Dr. B. Vallat

Directeur général OIE

12 Rue de Prony

F-75017 PARIS

ANNEX

[pic]

Original: English

September 2007

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

Paris, 17-28 September 2007

______

The OIE Terrestrial Animal Health Standards Commission (the Code Commission) met at the OIE Headquarters in Paris on 17 - 28 September 2007.

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

The Code Commission reviewed the agenda papers, addressing comments that Members had submitted by 15 August and amending texts in the OIE Terrestrial Animal Health Code (the 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 IV and XVII (General obligations and classical swine fever), amendments made at this meeting (September 2007) are shown with a coloured background to distinguish them from those made prior to the 75th General Session.

Members should note that, unless stated otherwise, texts submitted for comment may be proposed for adoption at the 76th General Session. Depending on the comments received on each text, the Code Commission will identify, in the report of its March 2008 meeting, the texts proposed for adoption in May 2008.

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. 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 February 2008 to be considered at the March 2008 meeting of the Code Commission. Comments should be sent to the International Trade Department at: trade.dept@oie.int.

Dr Thiermann welcomed members of the Code Commission to OIE Headquarters on behalf of Dr Vallat, Director General, who was unable to join the meeting due to mission travel. He stated that Dr Vallat would meet with the Code Commission on his return. Dr Thiermann commented that the Code Commission had a heavy workload for this meeting and thanked members for taking the responsibility to lead the discussion on particular agenda items. He advised members that joint meetings would be held with the Scientific Commission for Animal Diseases (the Scientific Commission) and with the Biological Standards Commission.

The Code Commission acknowledges comments submitted by Australia, Canada, Chinese Taipei, the European Union (EU), Japan, New Zealand, South Africa, Switzerland and the United States of America (USA).

Community comments:

The Community thanks and congratulates the OIE and especially the TAHSC for the tremendous work achieved. It reiterates its will to continue participating in this work as much as possible.

Community general comments are included in Part C of this report and specific comments in each Annex.

The first general comment would be that the answers given by the OIE to the Community's last comments lack some precision and argumentation. The Community tries as much as possible to give rationale to its comments, and if these comments are not taken on board, then it should also be better justified by arguments directly contradicting the rationale or strong enough not to retain them . It should not be felt that some changes of the Code are not motivated by a wish of actual improvement and based upon solid and practical argumentation.

Another general comment concerns the deletion of the word "approved" before "laboratory": even if the definition of laboratory implies official approval, it should be clearly brought to the attention of the Members who read the chapters; thus it seems much preferable to retain the former wording of "approved laboratory".

Finally, it appears that the translation of the drafts in some places differs too much from the English version; this should be addressed after the next TAHSC meeting.

A. MEETING WITH THE DIRECTOR GENERAL

Dr Vallat joined the Code Commission for a discussion on strategic issues. He advised the Code Commission on important developments in Africa, particularly the view of some African Members that the OIE is not addressing the need for ‘commodity-based standards’. Dr Vallat instructed the Code Commission to ensure that Code provisions relevant to trade in commodities be made more visible, perhaps by working with an expert to develop guidelines on using the current Code to support trade on a commodity basis. Clearly the OIE must take into account the disease status of a country. However, if procedures or treatments can be used to manage risk, the Code currently supports export according to appropriate treatments.

On classical swine fever (CSF), Dr Vallat noted that the OIE supports the use of the DIVA principle (differentiating infected and vaccinated animals) but, for the moment, the OIE cannot recommend the use of commercially available marker vaccines in domestic pigs in all situations. The Biological Standards Commission will address this question. The OIE does, however, recommend and support the use of oral vaccines in wild pigs and this approach should be strengthened and be accompanied by systematic surveillance of wildlife for CSF infection based on the standards of the OIE. Dr Vallat noted that a new Code chapter on this topic is needed soon. The Director General noted that according to the current Code , the OIE could not treat CSF in the same way as it treats avian influenza and that the CSF situation in wild pigs should be taken into account in determining the CSF status of a country/zone. In regard to vector borne diseases, Dr Vallat mentioned the worrying situation with bluetongue in Europe and advised his view that vaccination will certainly be needed to prevent disruption of live animal trade. Used correctly, vaccines can help provide conditions for safe trade. Therefore, it would be appropriate that the OIE update its recommendations on the topic of bluetongue vaccines. On rinderpest, the Director General noted Dr Thiermann’s advice that further work is to be done in formatting the chapter and appendix but that no significant change to the text adopted in May was proposed.

On animal welfare, Dr Vallat reminded the Code Commission of the need to take account of the constraints of developing countries when producing Code texts. The OIE should take a practical rather than a philosophical approach and aim to develop standards that can be applied by all OIE Members.

Dr Vallat noted that the Code Commission endorsed the revised OIE PVS Tool. He also commented that the concept of ‘community animal health worker’ is very important in Africa and other regions. The OIE will develop some guidance on this topic, which will be addressed by the ad hoc Group on Evaluation of Veterinary Services.

B. JOINT MEETINGS OF COMMISSIONS

1. Meeting of the Code Commission and the Scientific Commission

a) Definitions of surveillance, monitoring and infection (Chapter 1.1.1.)

The Commissions discussed the difficulties in reaching universal consensus and agreed to use relevant dictionary definitions of these terms, without variation.

A new definition was agreed for infection : ‘the entry and development or multiplication of an infectious agent in the body of man or animals’ (from A Dictionary of Epidemiology 4th Ed. 2001 Edited by John M. Last. Oxford University Press).

b) Requirement for a buffer zone (Chapter 2.2.10.)

The Code Commission discussed the Scientific Commission’s recommendation that it should not be obligatory to require a buffer zone or physical/geographical barrier in Articles 2.2.10.3., 2.2.10.4. and 2.2.10.5. The two Commissions could not reach a consensus and the Code Commission decided not to make these amendments, but welcomes comments from Members on this proposal.

c) Containment zone (Chapter 2.2.10.)

The Commissions jointly examined Members’ comments and agreed to modify existing text in Chapter 2.2.10. as follows:

- An effective containment strategy (not necessarily stamping out) is required.

- The primary outbreak and the likely source of the outbreak should be identified.

- The period to establish a containment zone should read ‘no new cases…within a minimum of two incubation periods…’.

The modified text on containment zone from Chapter 2.2.10. was taken into account in drafting a generic text on containment zone and incorporated into Chapter 1.3.5.

The amended text may be found at Annex VII .

d) Compartmentalisation for vector borne diseases

The Commissions discussed the potential application of the concept of compartmentalisation for vector borne diseases. While the two Commissions did not reach consensus on whether compartmentalisation could be systematically applied to these diseases, it was agreed to add the term ‘ establishment’ in Article 3.8.10.3., to be congruent with the definition of compartmentalisation in the Code .

e) Classical swine fever (Chapter 2.6.7.)

The Commissions discussed the rationale for the Code ’s treatment of classical swine fever (CSF) infection in wildlife, noting that findings of FMD in wildlife affect the FMD status of the country whereas findings of avian influenza (AI) in wild birds do not affect the AI status of the country. It was agreed that the key factor to consider is whether CSF is endemic in the wild pigs or occurring sporadically (e.g. incursions from a neighbouring country). On the basis of discussion between the Director General and the Code Commission, it was decided that findings of CSF infection in wild pigs would continue to be taken into account in determining the status of the country or zone.

f) Checklist on the application of compartmentalisation

It was agreed that no further work need be done on the Checklist on the application of compartmentalisation for AI/ND for the time being.

g) BSE chapters and appendices (Chapter 2.3.13. and Appendices 3.8.4. and 3.8.5.)

It was agreed that an ad hoc Group on BSE would be convened to review Code texts on BSE (Chapter 2.3.13., Appendix 3.8.4. and Appendix 3.8.5.) and the BSE country status questionnaire to ensure congruency. In the course of this work, the ad hoc Group would be asked to review Members’ comments on Appendix 3.8.5. The Commissions agreed that once guidelines and questionnaires for categorisation of countries had been revised, they should be adopted and published in the Code .

h) Commodity-based measures in the Code

On trade in livestock commodities, the Commissions agreed that an expert group should be convened to develop, if possible, an appropriate ‘systems approach’ to make more visible and to give more details on safe commodities, starting with deboned, matured and pH tested beef.

i) Equine influenza (Chapter 2.5.5.)

Article 2.5.5.3. (surveillance for equine influenza) was discussed in light of a Member’s comment. The requirement for surveillance was considered to be too prescriptive and the text was modified accordingly.

j) Approved laboratory

The Scientific Commission requested to use “ laboratory which is approved “ instead of “ approved laboratory ”. As the definition of “ laboratory ” in the Code includes the requirement for approval by the Veterinary Authority, the Code Commission decided to delete the word “ approved ” before “ laboratory ” throughout the Code .

k) Administrative procedure for reconfirmation of disease status of countries / zones

In keeping with the Resolution adopted at the 75th General Session, the Scientific Commission asked the Code Commission to add requirements for annual reconfirmation of country and zone disease status as currently required for FMD. The Code Commission made the appropriate changes.

The amended text may be found at Annexes VII, VIII, IX and XII.

2. Meeting of the Code Commission and the Biological Standards Commission

a) Rabies (Chapter 2.2.5.)

The Commissions discussed the question of whether findings of bat lyssavirus infection should affect the rabies free status of a country, noting the advice of the Scientific Commission that European and Australian bat lyssaviruses should be treated equally. The Commissions agreed that it is important to encourage reporting of lyssaviruses in bats to get a better understanding of how the virus behaves in wildlife and to protect human health. The Code should encourage reporting and at the same time discourage unnecessary impediments to international trade. In the short term, the Commissions agreed that the Code should be amended to the effect that findings of Australian bat lyssaviruses do not affect a country’s rabies free status.

The Commissions noted the policy of the World Health Organization (WHO) that a rabies free country is one that has not reported lyssavirus infection in man or any animal species, including bats, at any time during the previous two years and agreed that the OIE should review the treatment of lyssaviruses in the Code in view of the increasing importance of these emerging viruses.

b) Paratuberculosis (Chapter 2.2.6.)

On paratuberculosis, the Commissions agreed that the Biological Standards Commission would track developments in diagnostic testing. Once effective diagnostic methods are available, the OIE should develop a chapter on paratuberculosis.

c) Bovine tuberculosis (Chapter 2.3.3.)

On bovine tuberculosis, the Biological Standards Commission undertook to examine alternatives to tuberculin testing and draft appropriate text for inclusion in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (the Manual ).

d) Classical swine fever (Chapter 2.6.7.)

On classical swine fever, Dr Edwards advised that the current marker vaccines have shortcomings and it is not yet appropriate to include them in Chapter 2.1.13. of the Manual . However, the Biological Standards Commission will keep this matter under review.

e) Equine rhinopneumonitis (Chapter 2.5.7.)

On equine rhinopneumonitis, the Commissions discussed the proposal of a Member to clarify that ‘clinical signs of equine herpesvirus type 1 (EHV1) infection’ refers to the abortigenic or paralytic forms of infection. The Commissions agreed that EHV1 is virtually ubiquitous and that the Code should not impose unnecessary measures on trade. Clinical signs of EHV1 and EHV4 infection can be indistinguishable. A wide variety of clinical signs may be found in EHV1 infection. Therefore, it was agreed to retain the title of the chapter as Equine rhinopneumonitis.

f) Porcine reproductive and respiratory syndrome

The Commissions discussed the priority to develop a text on porcine reproductive and respiratory syndrome (PRRS) in the chapter, given the serious impact of the disease recently in Asia. PRRS is listed by the OIE and the Manual contains guidance on the disease. Dr Thiermann undertook to raise this with the Director General of the OIE.

g) Equine encephalosis

On equine encephalosis, the Biological Standards Commission advised that this orbivirus infection, which is among the differential diagnoses for African horse sickness, appears to be an emerging disease in Africa. Dr Edwards indicated that the Biological Standards Commission would be examining it further. Dr Thiermann clarified that the Code Commission does not intend to work on this disease at this time.

h) West Nile fever

The Commissions discussed the West Nile fever test requirements. At this time, validated tests are only available for horses and no test has yet been validated for poultry. As ducks and geese pose a risk of transmitting West Nile virus (WNV), the Commissions agreed that the testing requirement should apply to these poultry. The Biological Standards Commission considered that the PCR based test, validated for horses, is likely to be applicable to ducks and geese and they are studying this matter.

The changes to the Code chapter are reflected in Annex XX .

i) Evaluation of veterinary services

The Commissions discussed the revised OIE PVS Tool with particular reference to the new section dealing with the quality of diagnostic laboratories. Dr Edwards expressed some concern that a complete review of diagnostic laboratories may be beyond the scope of a PVS evaluation. The Biological Standards Commission has developed a detailed quality standard for laboratories, including competence in quality assurance systems.

While it is clear that the PVS evaluation does not have the goal of assessing laboratories against the OIE laboratories quality standard, the Biological Standards Commission felt that some expertise on laboratory operation and management should be included in the ad hoc Group on Evaluation of Veterinary Services and that the proposed criteria should be reviewed.

j) Reformatting of the Code and the Manual

The Commissions discussed the proposal to move pertinent sections between the Code and the Manual . The Commissions agreed in principle to the proposal and asked the responsible departments of the OIE to advise on how best to manage this.

C. EXAMINATION OF MEMBERS’ COMMENTS AND WORK OF RELEVANT EXPERT GROUPS

1. General definitions

Community comments:

The Community would point out that the OiE should try to avoid inconsistencies when the general definitions are changed with regard to the definitions in specific chapters. The Community does not believe that just copy and pasting from an epidemiology book achieves clear and correct definitions as far as the Code and its use are concerned.

The Code Commission examined comments from New Zealand, South Africa, the Scientific Commission, the ad hoc Group on Epidemiology and an expert.

a) General definitions (Chapter 1.1.1.)

b) Status report on incorporation of new definitions (Veterinary Authority, etc.)

c) New definition proposed by the Permanent Animal Welfare Working Group (PAWWG)

Submissions were received on the definition ‘ Slaughterhouse/Abattoir, Collecting centre, Flock, Herd, Infection, Laying birds, Monitoring, Notifiable disease, Notification, Clustering, Official veterinary control, Quarantine station, Risk, Risk assessment, Sanitary measure, Surveillance and Veterinary Services’ .

The Code Commission considered that definitions should be harmonized with those in the Aquatic Code and Codex wherever possible. It accepted recommendations on amending and deleting certain definitions and on including some new definitions and made appropriate modifications.

The Code Commission agreed with the PAWWG that there is a need to develop a definition for ‘animal welfare’ in the Code and supported the definition proposed by the PAWWG. The proposed definition is consistent with the general principles for animal welfare contained in the Code (including, for example, the ‘five freedoms’) and also consistent with the approach taken in the Code to date, whereby the texts focus on outcomes rather than the design of systems. It also addresses the concept whereby animal welfare can be ‘good’ or ‘bad’. The Code Commission considered that this definition would be appropriate for inclusion in the Code and amended Article 1.1.1.1. accordingly.

The revised chapter, which is presented at Annex III , is provided to Members for comment.

2. Model certificates

The Code Commission considered comments from Australia, the EU, Japan, New Zealand, Switzerland and an expert.

a) General obligations (Chapter 1.2.1.)

The Code Commission noted that several Members commented positively on the recommendations of the ad hoc Group on Model Veterinary Certificates. However, at least one Member indicated that the proposed requirements are excessive in some respects. The Code Commission recommended that the ad hoc Group continue working on this topic and prepare a revised text, taking into account Members’ comments, for the Code Commission to review at its spring meeting.

The Code Commission examined Members’ comments on the text of the chapter and introduced appropriate changes.

Community comments:

The Community can support the draft changes, but asks the TAHSC to take into account a few specific comments in Annex IV.

b) Notes for guidance on veterinary certificates for international trade in live animals, hatching eggs and products of animal origin (Appendix X.X.X.)

The Code Commission recommended that the ad hoc Group continue working on this topic and prepare a revised text, taking into account Members’ comments, for the Code Commission to review at its spring meeting.

Community comments:

The Community wishes to continue and help in this matter, as the model certificates seem now to be nearly ready for an adoption in May 2008.

c) Other horizontal chapters

An expert provided advice on the harmonisation of several horizontal Code chapters with those in the Aquatic Animal Health Code (see discussion under the agenda item on dividing the Code into two volumes).

Community comments:

The Community can support the draft changes, but asks the TAHSC to take into account a few specific comments in Annex IV.

The revised chapters, which are presented at Annex IV , are provided to Members for comment.

3. Evaluation of Veterinary Services

a) Chapter 1.3.3. and Chapter 1.3.4.

b) Report of the ad hoc Group on the Evaluation of Veterinary Services

c) OIE Tool for the Evaluation of Performance of Veterinary Services (OIE PVS Tool)

The Code Commission noted the report of the ad hoc Group on Evaluation of Veterinary Services ( Annex XXIX ) and concurred with the Group’s recommendations, including on modification of the content and name (‘OIE Tool for the Evaluation of Performance of Veterinary Services’, OIE PVS Tool). The Code Commission noted that the revised PVS Tool would be further discussed at a Seminar for PVS assessors that will take place in Lyon on 20-22 November 2007.

Community comments:

The Community wishes to continue and help in this matter.

A Member sought clarification on the status of the OIE PVS Tool under the SPS Agreement. The Code Commission advised that Chapters 1.3.3. and 1.3.4. are international standards and the OIE PVS Tool is a practical guide on applying these standards.

4. Zoning and compartmentalisation

The Code Commission reviewed comments from the EU, Japan and the ad hoc Group on Epidemiology.

Community comments:

The Community can support the draft changes, but asks the TAHSC to take into account a few specific comments in Annex V.

The Community will soon send to the OIE the outcome of its work on the compartmentalisation concept and its practical implementation for trade.

a) Chapter 1.3.5.

b) General guidelines on the application of compartmentalisation (Appendix X.X.X.)

c) Checklist on the practical application of compartmentalisation for avian influenza and Newcastle disease

d) Use of the compartmentalisation concept for vector borne diseases

The Code Commission examined Members’ comments on Chapter 1.3.5. (Zoning and compartmentalisation), the General guidelines on the application of compartmentalisation (Appendix X.X.X.) and the comments of the ad hoc Group on Epidemiology on the Checklist on the practical application of compartmentalisation for avian influenza and Newcastle disease (the Checklist).

The Code Commission reviewed the text in Chapter 2.2.10. on a containment zone for FMD and included similar text, modified to be generally applicable, in Chapter 1.3.5. The containment zone is considered to be a particular example of zoning. While its establishment depends upon similar general considerations, some specific provisions apply to the establishment of a containment zone. At this stage, the containment zone has been discussed in the context of FMD and Members’ comments address the containment zone for this disease. The Code Commission is of the opinion that a containment zone could be applied to other diseases in the Code and therefore added a generic reference in Chapter 1.3.5.

The Code Commission and the Scientific Commission did not support the proposal of the ad hoc Group on Epidemiology to review the Checklist at its next meeting. The Code Commission agreed that a review could be done at some time in the future but felt that it would be more useful to wait for countries to gain some practical experience in applying compartmentalisation for avian diseases then use this experience in reviewing the document.

The revised chapters and appendices, which are presented at Annex V , are provided to Members for comment.

5. Rabies (Chapter 2.2.5.) (also see meeting with Biological Standards Commission)

Community comments:

The Community can support the draft changes, but asks the TAHSC to take into account a specific comment in Annex VI.

The Code Commission discussed Members’ comments with regard to the status of a free country where bat lyssavirus infection is reported. In the short term, the Code Commission decided to amend the Code to the effect that the presence of Australian bat lyssaviruses does not affect rabies free status (same as for European bat lyssaviruses).

The revised chapter, which is presented at Annex VI , is provided to Members for comment.

6. Foot and mouth disease

The Code Commission reviewed comments from Australia, the EU, Japan, South Africa and the ad hoc Group on Epidemiology.

a) Chapter 2.2.10.

Community comments:

The Community can only approve the proposed changes, if its comments are taken on board.

The Code Commission reviewed Members’ comments and the advice of the ad hoc Group on Epidemiology on Chapter 2.2.10. The Code Commission accepted several recommendations of this Group as it agreed with the rationale proposed.

In the case of containment zone (Article 2.2.10.7.), the Code Commission agreed with the Scientific Commission that ‘two incubation periods’ is the minimum required period to demonstrate the effective establishment of a containment zone.

The Code Commission did not accept a Member’s recommendation to address ‘associated risk’ as it considered that these concepts were already covered by the epidemiological investigation to be carried out by the Veterinary Authority in seeking to establish the containment zone. In regard to the proposal to establish a buffer zone around the containment zone, the Code Commission considered that the general provisions for zoning already address this point.

The Code Commission did not accept the recommendation of the ad hoc Group on Epidemiology to add ‘single case or clustering of cases’ because it considered that this was too narrow in comparison with the previously adopted text.

The Code Commission accepted a Member’s proposal that effective control measures, other than stamping out, could be a basis for the establishment of a containment zone.

In regards to comments regarding a need to demonstrate the effectiveness of vaccination, the Code Commission noted that the definition of vaccination already addresses this point.

In response to requests of some African Members (also see discussion under meeting with the Scientific Commission), the Code Commission decided to continue the work of developing lists of ‘safe commodities’, as currently found in Article 2.3.13.1. (BSE). As a next step, the Code Commission will ask the Director General to convene an expert group to provide more advice on trade in deboned, matured and pH tested beef, and other commodities, from countries/zones that are not free of FMD and other serious diseases.

b) Guidelines on surveillance for foot and mouth disease (Appendix 3.8.7)

Community comments:

The Community can approve the proposed changes.

On surveillance guidelines for FMD, the Code Commission noted but did not accept the recommendation of the ad hoc Group on Epidemiology to replace Article 3.8.7.6. (countries or zones applying for freedom from FMD following an outbreak). The Code Commission considers that the existing text is appropriate. It has been developed over a number of years on the basis of considerable Members’ comments and there is insufficient rationale to make the proposed text amendment.

c) Virus inactivation procedures (Appendix 3.6.2)

Community comments:

The Community can approve the proposed changes.

On the basis of expert advice, the Code Commission added a new article (3.2.6.8) on casings of small ruminants and pigs. The expert advised that these conditions could be extended to cattle, based on the fact that FMDV tropism is similar in cattle and in small ruminants. Given that the original experiment (see Wijnker et al., [2007] Removal of foot-and-mouth disease virus infectivity in salted natural casings by minor adaptation of standardized industrial procedures. International Journal of Food Microbiology , 115 , 214–219) was performed on casings of small ruminants, the Code Commission decided that the application of Article 3.2.6.8. to cattle should be studied further.

The revised chapters and appendices, which are presented at Annex VII , are provided to Members for comment.

7. Rinderpest

a) Chapter 2.2.12.

Community comments:

The Community cannot approve the proposed changes.

b) Guidelines on surveillance for rinderpest (Appendix 3.8.2.)

Community comments:

The Community can approve the proposed changes.

The Code Commission noted that the ad hoc Group on Epidemiology had reviewed Chapter 2.2.12. and Appendix 3.8.2. and had recommended some amendments to the chapter (to include the concept of zoning and to amend Articles 2.2.12.2. and 2.2.12.3.) and had completely rewritten the surveillance guidelines. The Code Commission examined proposals for amendments to this chapter and guidelines. As these amendments resulted in extensive reformatting of the chapter and guidelines, the Code Commission requested that the Scientific Department highlight the changes by double underline and strikeout for the Code Commission to consider at its March meeting.

The revised chapter and appendix, which are presented at Annex VIII , are provided to Members for comment.

8. Contagious bovine pleuropneumonia (Chapter 2.3.15. and Appendix 3.8.3.)

The Code Commission reviewed several recommendations of the ad hoc Group on Epidemiology on Chapter 2.3.15. and noted that the Group recommended revision of the related Appendix 3.8.3. The Code Commission noted that the Scientific Commission is continuing to work on these texts.

Community comments:

The Community can only approve the proposed changes in Chapter 2.3.15, if its comments are taken on board. It approves the changes in Appendix 3.8.3.

The revised chapter and appendix, which are presented at Annex IX , are provided to Members for comment.

9. General guidelines on animal health surveillance (Appendix 3.8.1.)

The Code Commission did not accept a proposal from the ad hoc Group on Epidemiology to modify Article 3.8.1.4. on sampling methods, on the basis that it is too prescriptive. The Code should retain some flexibility to provide for the different conditions that apply in Members’ territories.

10. Bluetongue

The Code Commission considered comments from Australia and South Africa.

a) Chapter 2.2.13.

The Code Commission considered a request to incorporate the concept of compartmentalisation in this chapter. The Code Commission is on the opinion that the word “compartment” cannot simply be inserted after “country” or “zone” in each chapter dealing with vector born diseases. Rather, the concept needs to be introduced on the basis of proper consideration of the epidemiology of the disease.

b) Guidelines on surveillance for bluetongue (Appendix 3.8.10.)

Community comments:

The Community can support the draft changes, but asks the TAHSC to take into account a few specific comments in Annex X.

The Code Commission accepted the concept of compartmentalisation for bluetongue insofar as this applies to an individual establishment (Article 3.8.10.3. was modified). However, the Code Commission saw the need for specific advice how the compartmentalisation could be applied in practice in more than one establishment.

A Member’s recommendation to make reference to the density of the vector population in Article 2.2.13.2. was referred to the Scientific and Technical Department on the basis that it raises a new scientific question and should be studied by appropriate experts.

The Code Commission recommended to the Director General of the OIE to reconvene an ad hoc group on proposing more details on the use of vaccination.

The revised appendix, which is presented at Annex X , is provided to Members for comment.

11. Bovine brucellosis (Chapter 2.3.1.)

The Code Commission reviewed comments from the ad hoc Group on Brucellosis on the text previously circulated, which contained extensive comments from Australia, Canada, Chinese Taipei, the EU, New Zealand, Switzerland and the USA.

The Code Commission noted that a new ad hoc Group will be convened to review Members’ comments and update the chapter accordingly.

12. Bovine tuberculosis (Chapter 2.3.3.)

The Code Commission addressed comments from Australia, New Zealand and the USA.

Community comments:

The Community cannot support the proposed changes. A new chapter for TB in deer should be drafted.

The request of two Members to modify references to diagnostic testing for tuberculosis were referred to the Biological Standards Commission.

In regard to a Member’s comment about the role of wildlife reservoirs, the Code Commission noted that the role of wildlife as animal disease reservoirs will be addressed by the OIE Working Group on Wildlife Diseases. However, the Code Commission proposed to make a number of amendments throughout Chapter 2.3.3., including the addition of farmed deer (multiple species) in the scope of the chapter. The comment from a Member regarding the need for a free country to conduct ongoing tuberculin testing and a comment regarding acceptable disease prevalence were addressed via appropriate amendments to Article 2.3.3.2. The proposal to refer to the importing country’s free status in introducing the import measures to be applied was not accepted. The Code Commission instead reminded Members that countries are not expected to apply import measures in regard to diseases that occur within their territories and that are not the subject of official control or eradication programmes.

In response to a comment from a Member, Article 2.3.3.10 was added to the chapter providing measures in regard to the importation of antler velvet of farmed deer. The time/temperature specified is a current industry standard for processing of antler velvet and was supported by the advice of an expert.

Article 2.3.3.2. was modified in response to comments of several Members, to reflect a more stringent approach to surveillance. The rationale for this change is that freedom is not equivalent to ‘low prevalence’. It is recognised that the sensitivity of surveillance systems means that surveillance can yield negative results but not be sufficiently sensitive to detect very low prevalence of infection. For this reason, such statements as Article 2.3.3.2. 3. should be phrased in terms of surveillance sensitivity. If the surveillance programme detects a case of infection, when confirmed, ‘free status’ will be lost and must be regained through the appropriate steps, as is currently the case for other diseases such as FMD and CSF.

The revised chapter, which is presented at Annex XI , is provided to Members for comment.

13. Bovine spongiform encephalopathy

The Code Commission considered comments from Canada, the EU, Japan, New Zealand and the USA. Members of the Scientific and Technical Department participated in the discussion.

a) Chapter 2.3.13.

Comments of the Community:

The Community would like the Code Commission to take into account its previous comments.

The Code Commission corrected an anomaly that had been found in Article 2.3.13.4. with an appropriate text modification. Article 2.3.13.15. (2) on the production of gelatine was modified to remove the reference to vertebrae (exclusion of skulls from cattle over 12 months of age was maintained in the text) and paragraph 3 was removed completely.

Article 2.3.13.16. was modified by splitting the sections dealing with tallow and dicalcium phosphate, to reflect the different risk management considerations for the two commodities (see Grobben et al., [2006] Inactivation of transmissible spongiform encephalopathy agents during the manufacture of dicalcium phosphate from bone. Veterinary Record , 158 , 361–366).

b) Risk assessment recommendations (Appendix 3.8.5.)

Members’ comments on Appendix 3.8.5. (risk assessment for BSE) were not addressed. The preferred approach would be to combine Appendix 3.8.5. with the BSE risk assessment questionnaire as discussed with the Scientific Commission. The Code Commission noted that an ad hoc Group will be convened to review all relevant BSE texts, including Members’ comments prior to developing single questionnaire and guidelines on the categorisation of countries.

The principle of combining the questionnaire with recommendations on risk assessment should also apply to FMD, rinderpest and CBPP.

The revised chapter and appendix, which are presented at Annex XII , are provided to Members for comment.

14. Equine influenza (Chapter 2.5.5.)

In response to a Member’s request for the rationale supporting 21 days residency requirement (Articles 2.5.5.6. and 2.5.5.7.), the Code Commission commented that there is no new scientific evidence, and recalled that the issue had been raised in May 2007, at which time it requested input from Members on this point. No such input has been received and therefore the Code Commission sees no reason to modify the recommendation.

The Community reiterates its request for data justifying the change that was made in May 2007, from 14 to 21 days in articles 6 and 7 if "there is no new scientific evidence". The explanation above is not satisfactory and should be reverse: it is not up to the Member Countries to justify their question; it's up to the TAHSC to give them answers.

The notation ‘under study’ was removed from Article 2.5.5.4. (semen) in light of expert advice, endorsed by the Scientific Commission, that semen is not a vehicle for the transmission of equine influenza.

The revised chapter, which is presented at Annex XIII , is provided to Members for comment.

15. Equine diseases (other than equine influenza and AHS)

a) Equine rhinopneumonitis (Chapter 2.5.7.)

Community comments:

The Community can approve the proposed change.

See discussion under Meeting with Biological Standards Commission.

b) Equine viral arteritis (Chapter 2.5.10.)

The Code Commission reviewed comments from a Member. The Code Commission recognised the need for isolation for live horses and made appropriate changes to the chapter as shown in Appendix 2.5.14. The Code Commission also incorporated a modification to Articles 2.5.10.2 and 2.5.10.3. to indicate that testing of a stallion should be conducted while he was in isolation.

Community comments:

The Community can approve the proposed changes but reiterates its former comments, while giving the OIE proposals for modifications in Annex XIV.

The revised chapters, which are presented at Annex XIV , are provided to Members for comment.

16. African horse sickness

a) Chapter 2.5.14.

Community comments:

The Community supports the proposed changes, but still cannot accept the chapter unless its only but essential comment is taken into account.

The Code Commission reviewed comments from Australia, the EU, New Zealand, South Africa, Switzerland and the USA. Appropriate changes were made in the chapter.

Comments from two Members questioning the feasibility of a seasonally free zone were forwarded to the Scientific Commission for expert opinion.

b) Guidelines on surveillance for African horse sickness (Appendix 3.8.X.)

The Code Commission reviewed comments from the EU, New Zealand, South Africa, Switzerland and the USA and made changes to the text accordingly.

The Code Commission amended text in the introduction of Appendix 3.8.X. referring to the issue of demonstrating country status rather than applying for recognition of free status. This change will also be applied to the bluetongue, CSF and AI chapters.

The revised chapter and appendix, which are presented at Annex XV , are provided to Members for comment.

17. African swine fever (Chapter 2.6.6.)

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

The Code Commission amended text of several articles to provide the text in full rather than rely upon cross references to other articles and to make the format of this chapter consistent with that of the CSF Chapter.

Community comments:

The Community can approve the proposed changes, but requests the TAHSC to take into account its comment in article 7. Furthermore, it should be defined what is meant by "adjacent country". Guidelines should be developed for the surveillance of African Swine Fever, and of its vectors.

The revised chapter, which is presented at Annex XVI , is provided to Members for comment.

18. Classical swine fever (also see discussion with the Biological Standards Commission)

a) Chapter 2.6.7.

Community comments:

The Community cannot approve the proposed changes unless its comments are taken into account. The answer given by the TAHSC to the Community former comments is not satisfactory at all, because it focuses on theory and not practice. It is clearly stated in the paragraph A of this report: "The OIE should take a practical rather than a philosophical approach and aim to develop standards that can be applied by all OIE Members". Thus maybe the chapter should be redirected to the relevant ad hoc group.

b) Guidelines on surveillance for classical swine fever (Appendix 3.8.8.)

The Code Commission reviewed comments from Australia, Canada, the EU, Japan, South Africa and the USA.

The text of several articles was modified to address Members’ recommendations, including on the use of vaccines for which OIE validated standards (as per Chapter I.1.3. of the Terrestrial Manual ) are available to differentiate infected and vaccinated pigs; and on the minimum residency period in relation to health certification of live pigs. Text in Appendix 3.8.8. was amended to reflect a Member’s recommendations on surveillance.

The revised chapter and appendix, which are presented at Annex XVII , are provided to Members for comment.

19. Avian influenza

a) Chapter 2.7.12.

b) Guidelines on the inactivation of avian influenza virus (Appendix 3.6.5.)

c) Guidelines on surveillance for avian influenza (Appendix 3.8.9.)

Community comments:

The Community can support the changes but would like its comments taken on board.

The Code Commission considered comments from the EU, Japan, South Africa, the USA and the ad hoc Group on Epidemiology.

In response to a Member’s comment, the Code Commission reiterated that the central concept is to require reporting of LPNAI and HPNAI in poultry for trade purposes, while reporting of HPNAI in wild birds is necessary for global surveillance purposes. For practical purposes, the Code Commission has adopted a definition of poultry as including all birds used to produce eggs or meat for consumption, in addition to other commercial activities described in Article 2.7.12.1. (2). The definition was therefore not modified.

A Member raised the concern that low pathogenic AI strains other than H5 and H7 might mutate into highly pathogenic subtypes and should, therefore, be included as notifiable strains. However, examinations of all highly pathogenic isolates since 1959 show that all were either H5 or H7. Based on expert advice, the Code Commission reiterated that low pathogenic subtypes should be limited to the H5 and H7 subtypes. There is no basis to include H9 subtypes or any other H subtypes. Nevertheless, there are recommendations (Article 2.7.12.18.) for measures to mitigate risk from low pathogenic notifiable subtypes in meat.

The Code Commission did not accept the recommendation of two Members that findings of antibodies to avian influenza be considered criteria for determining infection, recalling its previous advice that further investigations should be conducted to identify the source of the antibodies. Findings of antibodies should not be considered as an occurrence of infection if further investigation fails to isolate the virus or to detect viral RNA.

In response to a Member’s comment, the Code Commission did not accept that the definition for “non-poultry” had been expanded and that there is, therefore, no reason to change the measures recommended in Article 2.7.12.6. to manage the NAI risk posed by birds other than poultry.

In response to a Member’s comment to remove ‘under study’ from Articles 2.7.12.21., 22. and 23. dealing with products of poultry origin, the Code Commission decided to refer the request to an expert for advice including the application of the application of Appendix 3.6.5. to Newcastle disease.

A request from a Member to test a statistically representative sample of birds in large consignments for avian influenza and Newcastle disease was also referred for expert advice.

In response to a Member’s comment that the Code should specify that new containers should also be sanitized, the Code Commission advised its view that new containers would not be expected to be contaminated.

In conclusion, the Code Commission noted that no substantive new scientific issues had been raised by Members on the avian influenza chapter, nor on the appendix, suggesting that the issues raised during the last few years have been largely addressed and these texts can be considered as stabilised.

The revised chapter and appendix, which are presented at Annex XVIII , are provided to Members for comment.

20. Newcastle disease

a) Chapter 2.7.13.

b) Guidelines on surveillance for Newcastle disease (Appendix 3.8.X.)

c) Guidelines on the inactivation of the Newcastle disease virus

Community comments:

The Community can support the changes but would like its comments taken on board.

The Code Commission considered comments from Canada, Chinese Taipei, the EU, Japan, New Zealand, South Africa, Switzerland, the USA and the ad hoc Group on Epidemiology (which reviewed the chapter to make it consistent with Chapter 2.7.12. on avian influenza).

The Code Commission accepted a proposal to improve the definition of Newcastle disease and modified Article 2.7.13.1. accordingly. In the same article, the definition of ‘poultry’ was modified to align with the definition in Chapter 2.7.12. on avian influenza. Guidance was also provided on the appropriate trade response to reports of infection with vNDV.

A Member’s recommendation to modify Article 2.7.13.2. by including a reference to risk assessment was not accepted. The Code Commission considered that risk assessment is needed for avian influenza because of its zoonotic nature and the large number of epidemiological factors that need to be taken into account in determining the status of a country, zone or compartment. Members may choose to conduct a risk assessment for Newcastle disease but it is not necessary to specify that this should be done.

Article 2.7.13.7. was deleted to make the chapter congruent with the avian influenza chapter and because the Code Commission considered that trade in this commodity was unlikely to occur in practice.

The Code Commission made a number of amendments to the chapter and to Appendix 3.8.X., with a view to making these texts more consistent with equivalent texts on avian influenza.

On the inactivation of Newcastle disease virus (NDV), the Code Commission reviewed advice provided by experts and noted that it is feasible to develop time/temperature parameters for the inactivation of NDV. However, the advice would need to be further developed and formatted in a manner that is appropriate to the Code . The Code Commission decided to request an expert to prepare a draft text.

The revised chapter and appendix, which are presented at Annex XIX , are provided to Members for comment.

21. West Nile fever (Chapter 2.X.XX.) (Also see discussion with Biological Standards Commission)

Community comments:

The Community acknowledges the work of the TAHSC on this chapter but cannot support this draft. The whole Chapter should remain under study, and Guidelines for surveillance should be drafted and presented at the same time. The ad hoc group should include more experts than at present, and the Community would be happy to help in this regard.

The Code Commission addressed comments from Australia, Canada, the EU, Japan, New Zealand, South Africa, Switzerland and the USA.

The Code Commission accepted a Member’s recommendation to delete most of the opening Article because this information is well covered in the Manual . The Code Commission did not accept a proposal to include human cases as a determinant of a country’s West Nile fever (WNF) status as this approach is not taken in the Code for most of other zoonotic diseases. A list of commodities that are safe for trade was added at the beginning of this chapter. In response to Members’ commenting that it would be difficult to establish a compartment for WNF, as it affects equidae and is transmitted by vectors, the Code Commission noted that similar issues would be faced in establishing a compartment for other vector borne diseases, such as bluetongue and African horse sickness. A number of other amendments were made, including modifying the references to WNF vectors to read ‘likely to be competent’.

The revised chapter, which is presented at Annex XX , is provided to Members for comment.

22. Draft guidelines on the design and implementation of identification system to achieve animal traceability

Community comments:

The Community can support the changes but would like its comments taken on board.

The Code Commission addressed comments from Canada, the EU, Japan, New Zealand and the USA.

In response to Members’ proposals to include commercial and zootechnical aspects in the desired outcomes of an identification system to achieve animal traceability, the Code Commission decided to instead include the term ‘animal husbandry’.

The Code Commission forwarded the amended text to the Animal Production Food Safety Working Group (APFSWG) for further consideration.

The revised appendix, which is presented at Annex XXI , is provided to Members for comment.

23. Guidelines on the control of hazards of animal health and public health importance in animal feed

Community comments:

The Community welcomes the TAHSC work in this field but believes that still more clarity is needed in particular for the definitions.

The Code Commission addressed comments from Australia, Canada, the EU, New Zealand and the USA.

The Code Commission modified the scope of the guidelines to include all terrestrial animals, not just food producing animals, and made several other modifications in response to Members’ comments.

The Code Commission forwarded the amended text to the APFSWG for further consideration, including for the APFSWG to verify any text changes required in view of the changed scope.

The revised appendix, which is presented at Annex XXII , is provided to Members for comment.

24. Guidelines on the detection, control and prevention of Salmonella Enteritidis and S . Typhimurium in poultry producing eggs for human consumption (Appendix 3.10.2.)

Community comments:

The Community welcomes the TAHSC work in this field and wishes to participate more.

The Code Commission welcomed the comments of Australia, Canada, the EU, Japan, South Africa and the USA on these draft Guidelines.

The Code Commission considered most, but not all, Members’ comments. The Code Commission did not agree with a Member’s recommendation that the guidelines not contain provisions on egg hygiene and collection. Rather, the Code Commission considered that the guidelines should cover all activities on the farm, including egg hygiene and collection.

The Code Commission recommended that the ad hoc Group continue working on this topic and prepare a revised text, taking into account Members’ comments, for the Code Commission to review at its spring meeting. The ad hoc Group should commence drafting guidelines on the detection, control and prevention of Salmonella in broilers. It should also review the Code Chapter on hygiene and disease security procedures in poultry breeding flocks and hatcheries to assure consistency between the texts.

The Code Commission forwarded the Members’ comments to the APFSWG for further consideration, prior to forwarding it to the ad hoc Group.

25. Animal welfare

Community position:

The Community thanks the OIE Code Commission for its work that improves the clarity and applicability of the Guidelines on the transport, slaughter and humane killing of animals and appreciates that many of the previous Community comments have been taken into account in the revised appendices.

Furthermore, the Community welcomes the improvements of the text of the draft guidelines on dog population control and wishes to present further comments as inserted in revised Annex.

The Community strongly supports the OIE work and initiatives in the development of new standards.

a) Guidelines on the transport of animals by sea and land

b) Ad hoc Group on slaughter and humane killing

c) Draft guidelines on dog population control

d) Update on 2 nd OIE Global Conference on Animal Welfare 2008

e) Update from PAWWG meeting 5-7 September 2007

- animal production systems

- control of dog populations

- laboratory animals

- wildlife harvest

The Code Commission reviewed Members’ comments on current and proposed texts and the recommendations of the PAWWG in response to these comments. Comments had been provided on existing Code appendices by Australia, the EU and South Africa and on the discussion paper on animal production systems by Canada and the USA.

The Code Commission generally supported the PAWWG’s recommendations and made some additional amendments.

Draft guidelines on dog population control (comments received from Canada, the EU, Japan, New Zealand and the USA.)

Dr Thiermann informed the Code Commission of the process used to develop the guidelines, including the important role played by the PAWWG. The guidelines fall within the OIE mandates for protection of animal health, public health and animal welfare. One of the primary objectives of the guidelines is to help developing countries deal with the serious human health risks posed by free ranging dogs carrying rabies and other zoonoses. The Code Commission considers it particularly important that these guidelines should address issues faced by developing countries and regretted that no comments on the draft texts had been received from any such countries. The Code Commission strongly urges developing Members to offer comment on the revised text, as it is in those countries where there is the greatest need for intervention in the control of dog populations.

The revised appendices, which is presented at Annex XXIII , is provided to Members for comment. The report of the fifth meeting of the Working Group on Animal Welfare is presented at Annex XXVIII for information.

26. Infectious bursal disease (IBD)

A Member requested that the Code Commission reconsider the submission of the revised IBD Chapter that had been presented at the 69th General Session in 2001. The Code Commission decided not to resubmit the chapter, in the absence of new scientific information on the transmissibility of IBD virus through poultry meat, as had been requested in the Code Commission report of December 2003. The Code Commission decided that only in the event of new scientific information supporting a lack of the transmission of IBD virus through meat would this matter be re-examined.

27. Small hive beetle

Community comments:

The Community welcomes this draft Chapter and can support this proposal provided some comments are taken on board.

Dr Thiermann outlined the history to this longstanding issue. Draft chapters had been provided by Members in 2005 and in 2006. In addition, a Member had provided a risk assessment on small hive beetle in 2005. The Code Commission considered that the two draft chapters were not significantly different and decided to propose the original text for consideration of Members.

The draft chapter, which is presented at Annex XXIV , is provided to Members for comment.

28. Leptospirosis (Chapter 2.2.4.)

The Code Commission reviewed comments provided by Australia and New Zealand.

In regard to leptospirosis, the Code Commission noted that this is an important disease in some Members and presents a risk to human health. However, the development of a chapter at this time is not a priority because the disease is virtually ubiquitous and international trade is not considered to increase the risks to human or animal health. Rather than leave a title and no chapter in the Code , the Code Commission decided to delete the title.

29. Paratuberculosis (Chapter 2.2.6.)

The Code Commission asked the Biological Standards Commission to monitor scientific developments on diagnostic testing for paratuberculosis. Once the testing methodology is improved the Code Commission will ask the Scientific Commission to prepare a chapter on paratuberculosis for inclusion in the Code .

D. OTHER ISSUES

30. Commodity-based measures in the Code (also see discussions with the Director General and with the Scientific Commission)

Community comments:

The Community strongly welcomes the OIE work in this field and wishes to participate.

In response to Members’ comments and mindful of the recommendation made at the OIE/AU-IBAR/FAO Seminar of OIE Delegates from the OIE’s Regional Commissions for Africa and for the Middle East: “Implementation of Animal Health Standards: the Quest for Solutions” Cairo, 11-13 October 2004, the Code Commission noted that further development of commodity-based measures for trade is a priority for the OIE.

The Code Commission discussed the need to devote more attention to making more visible and expanding the commodity specific recommendations in the Code . Specific recommendations on the safety of commodities, including from countries/zones that are not free of certain diseases, can be found in the Code . One example of this approach is the provision of a list of safe commodities, as currently found in Article 2.3.13.1. (BSE). However, the Code Commission concluded that an effort needs to be placed on the development of additional recommendations as appropriate.

While the eradication of diseases is the ultimate goal, there are diseases and country situations where this is not feasible in the short term. Therefore the intention of the Code Commission is to work with experts and with the Scientific Department in identifying all relevant scientific information available to expand on the recommendation of measures to render commodities safe for trade when originating from countries or zones that are not free of disease. Notwithstanding the importance of developing commodity standards, the quality and credibility of Veterinary Services and disease surveillance remain paramount.

The Code Commission reviewed a paper prepared by an OIE expert and agreed to place the document on the OIE internet site for guidance of Members. It is presented at Annex XXV for information.

As a next step, the Code Commission will ask the Director General to convene an expert group to provide advice on trading deboned, matured and pH tested beef, and other commodities, from countries/zones that are not free of FMD and other serious diseases.

31. Division of the Code into two volumes

Community comments: The Community welcomes the TAHSC work in this field.

The Code Commission noted the progress report prepared by the Secretariat and advice provided by an expert. The Code Commission endorsed the proposed approach and recommended some improvements. An outline of the planned approach to the restructuring of the Code may be found at Annex XXVI .

32. Report of OIE/FAO ad hoc meeting on the Guide to Good Farming Practice

Community comments: The Community welcomes the TAHSC work in this field.

The Code Commission welcomed the report of the OIE/FAO ad hoc Group meeting on the Guide to Good Farming Practice. The Code Commission advised that this document should not be included in the Code ; rather, it should be published jointly by OIE and FAO. The document was forwarded to the APFSWG for further consideration. The report of the ad hoc Group is presented at Annex XXX for information.

33. Other documents:

a) The Role of the Veterinary Services in Food Safety

Community comments: The Community welcomes the TAHSC work in this field.

The Code Commission welcomed this concise and explanatory document and forwarded it to the APFSWG for further consideration.

b) Report of the OIE ad hoc Group on the Notification of Terrestrial Animal Diseases/Pathogenic Agents

The Code Commission was provided with the report of the 5th meeting of this ad hoc Group, but did not have time to review it. The Code Commission will review the report at its March meeting.

The report is appended for Members’ information and comments at Annex XXXI .

34. Future work programme

Community comments: The Community thanks the OIE for this very useful document. .

The updated work programme is shown in Annex XXVII .

35. Others

The next meeting of the Code Commission is scheduled for 10–14 March 2008.

Annex I

MEETING OF THE OIE

TERRESTRIAL ANIMAL HEALTH STANDARDS COMMISSION

Paris, 17–28 September 2007

1 Welcome-President of the Commission

2. Meeting with Director General

3. Joint meetings of commissions

- Meeting of the Code Commission and the Scientific Commissions

- Meeting of the Code Commission and the Biological Standards Commission

4. Examination of Member Countries’ comments and work of relevant Expert Groups

Item 1 General definitions

1. General definitions (Chapter 1.1.1.)

2. Status report on incorporation of new definitions (Veterinary authority, etc.)

3. New definition proposed by Permanent Animal Welfare Working Group (PAWWG)

Item 2 Model Certificates

4. General obligations (Chapter 1.2.1.)

5. Notes for Guidance on Veterinary Certificates for International Trade in Live Animals, Hatching Eggs and Products of Animal Origin (Appendix X.X.X)

6. Other horizontal chapters

Item 3 Evaluation of Veterinary Services

a) Chapter 1.3.3., Chapter 1.3.4.

b) Report of the ad hoc Group on the Evaluation of Veterinary Services

c) OIE Tool for the Evaluation of Performance of Veterinary Services (OIE PVS Tool)

Item 4 Zoning and compartmentalisation

7. Chapter 1.3.5.

8. General guidelines on the application of compartmentalisation (Appendix X.X.X)

9. Checklist on the practical application of compartmentalisation for avian influenza and Newcastle disease

10. Use of the compartmentalisation concept for vector borne diseases

Item 5 Rabies (Chapter 2.2.5.)

Item 6 Foot and mouth disease

11. Chapter 2.2.10

12. Guidelines on Surveillance for foot and mouth disease (Appendix 3.8.7)

13. Virus inactivation procedures (Appendix 3.6.2)

Item 7 Rinderpest

14. Chapter 2.2.12.

15. Guidelines on surveillance for rinderpest (Appendix 3.8.2.)

Item 8 Contagious bovine pleuropneumonia (Chapter 2.3.15. and Appendix 3.8.3.)

Item 9 General guidelines on animal health surveillance (Appendix 3.8.1.)

Item 10 Bluetongue

16. Chapter 2.2.13.

17. Guidelines on surveillance for bluetongue (Appendix 3.8.10.)

Item 11 Bovine brucellosis (Chapter 2.3.1.)

Item 12 Bovine tuberculosis (Chapter 2.3.3.)

Item 13 Bovine spongiform encephalopathy

a) Chapter 2.3.13.

b) Risk assessment recommendations (Appendix 3.8.5.)

Item 14 Equine influenza (Chapter 2.5.5.)

Item 15 Equine diseases (other than equine influenza and AHS)

a) Equine rhinopneumonitis (Chapter 2.5.7.)

b) Equine viral arteritis (Chapter 2.5.10.)

Item 16 African horse sickness

18. Chapter 2.5.14.

19. Guidelines on surveillance for African horse sickness (Appendix 3.8.X.)

Item 17 African swine fever (Chapter 2.6.6.)

Item 18 Classical swine fever

20. Chapter 2.6.7.

21. Guidelines on surveillance for classical swine fever (Appendix 3.8.8.)

Item 19 Avian influenza

22. Chapter 2.7.12.

23. Guidelines on the inactivation of avian influenza virus (Appendix 3.6.5.)

24. Guidelines on surveillance for avian influenza (Appendix 3.8.9.)

Item 20 Newcastle disease

25. Chapter 2.7.13.

26. Guidelines on surveillance for Newcastle disease (Appendix 3.8.X.)

27. Guidelines on the inactivation of the Newcastle disease virus

Item 21 West Nile fever (Chapter 2.X.XX.)

Item 22 Draft guidelines on the design and implementation of identification system to achieve animal traceability

Item 23 Guidelines on the control of hazards of animal health and public health importance in animal feed

Item 24 Guidelines on the detection, control and prevention of Salmonella Enteritidis and S . Typhimurium in poultry producing eggs for human consumption (Appendix 3.10.2.)

Item 25 Animal welfare

a) Guidelines on the transport of animals by sea and land

b) Ad hoc Group on slaughter and humane killing

c) Draft guidelines on dog population control

d) Update on 2nd OIE Global Conference on Animal Welfare 2008

e) Update from PAWWG meeting 5-7 September 2007

- animal production systems

- control of dog populations

- laboratory animals

- wildlife harvest

Item 26 Infectious bursal disease (IBD)

Item 27 Small hive beetle

Item 28 Leptospirosis (Chapter 2.2.4.)

Item 29 Paratuberculosis (Chapter 2.2.6.)

5. Other issues

Item 30 Commodity based measures in the Code

Item 31 Division of the Code into two volumes

Item 32 Report of OIE/FAO ad hoc Group meeting on Guide to Good Farming Practice

Item 33 Other documents

a) The Role of the Veterinary Services in Food Safety

b) Report of the OIE ad hoc Group on the Notification of Terrestrial Animal Diseases / Pathogenic Agents

Item 34 Future work programme

Item 35 Others

______________________

Annex II

MEETING OF THE OIE

TERRESTRIAL ANIMAL HEALTH STANDARDS COMMISSION

Paris, 17–28 September 2007

__________

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 W.-A. Valder (Vice President) Specialist in Public Veterinary Services Graue Burgstr. 79 D-53332 Bornheim GERMANY Tel.: (49)-(0)-2227-5850 E-mail: wolf-arno.valder@freenet.de | Prof. S.C. MacDiarmid (Secretary General) Principal International Adviser Risk Analysis, International Coordination and AdAdjunct Professor in Zoonoses and Animal Health, Adjunct Professor in Veterinary Biosecurity (Massey University) Biosecurity New Zealand P.O. Box 2526 Wellington NEW ZEALAND Tel.: (64-4) 894.0420 Fax: (64-4) 894.0731 E-mail: Stuart.MacDiarmid@maf.govt.nz |

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 | Prof. A.M. Hassan Veterinary Expert Federal Ministry of Animal Resources and Fisheries Khartoum SUDAN Tel.: (249) 912.163.979 Fax: (249) 834.75 996 E-mail: ahmedhassan32@hotmail.com hescobusiness@yahoo.com | Dr J. Caetano 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 |

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. Droppers Chargé de mission OIE Tel.: 33 (0)1 44 15 18 68 E-mail: w.droppers@oie.int | Dr S. 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 Chargé de mission International Trade Department OIE Tel.: 33 (0)1 44.15.18.92 E-mail: y.atagi@oie.int |

Annex III

CHAPTER 1.1.1. GENERAL DEFINITIONS

Community comments:

The Community can only support the draft changes, if the specific comments below are taken into account. It would point out that the OiE should try to avoid inconsistencies when the general definitions are changed with regard to the definitions in specific chapters. The Community does not believe that just copy and pasting from an epidemiology book achieves clear , correct and practically applicable definitions.

Article 1.1.1.1.

For the purposes of the Terrestrial Code :

Animal welfare

means the state of animal as regards its attempts to cope with its environment and includes both the extent of failure to cope and the ease or difficulty in coping.

Community comments:

The Community welcomes the definition of animal welfare and suggests further reflections as to consider the critical link between animal welfare and animal health, the mental state of the animals and their behavioural needs.

Approved abattoir

means premises used for the slaughter of animals for human consumption or animal feeding and approved by the Veterinary Authority for export purposes.

Area of direct transit

means a special area established in a transit country , approved by the relevant Veterinary Authority and placed under its immediate control, where animals stay for a short time pending further transport to their final destination.

Breeding birds

means birds kept for the purpose of producing hatching eggs .

Collecting centre

means a premise or a place where animals for breeding or rearing or animals for slaughter from different establishments or markets are collected together.

Community comments:

The definition of collecting centre should not be deleted at any cost. It can be a very important critical point as regards disease epidemiology, surveillance and control, and it cannot be assimilated with a market as in the majority of these centres there is no commercial activity.

Commodity

means live animals , products of animal origin, animal genetic material, intended for human consumption, for animal feeding, for pharmaceutical or surgical use or for agricultural or industrial use, semen, embryos/ova, biological products and pathological material .

Flock of birds

means any group of birds continuously housed in one building or part of a building separated from other parts of that building by a solid partition and having its own ventilation system, or, in the case of free range birds, any group of birds having common access to one or more buildings or More than one flock of birds may exist in one establishment .

Flock

means a number of animals of one kind kept together under human control or a congregation of gregarious wild animals. For the purposes of the Terrestrial Code , a flock is usually regarded as an epidemiological unit .

Herd

means a number of animals of one kind kept together under human control or a congregation of gregarious wild animals. For the purposes of the Terrestrial Code , a herd or flock is usually regarded as an epidemiological unit .

Community comments:

The same definition applies for flock and herd, so they should be in the same paragraph:

Flock or Herd

means a number of animals of one kind kept together under human control or a congregation of gregarious wild animals. For the purposes of the Terrestrial Code , a flock or herd is usually regarded as an epidemiological unit .

Infected country

means a country in which the absence of the disease under consideration has not been demonstrated by the requirements specified in the Terrestrial Code being met.

Community comments:

The Community cannot support this proposal as this definition seems overly severe, especially in the case of vector borne diseases, emerg ing diseases or any diseases for which no guidelines for surveillance have been adopted in the Terrestrial Code. The Community proposes the following wording:

Infected country

means a country in which an infection of the disease under consideration has been confirmed according to the OiE terrestrial Code or Manual.

There should still be the possibility of an "unknown status" when you have a country which has not proved its freedom but has not confirmed disease either.

Infection

means the presence of the pathogenic agent in the host entry and development or multiplication of an infectious agent in the body of men or animals .

Community comments:

The Community, although the above definition may be correct, feels that there are some practical problems. For example one could find the agent by PCR with no obvious multiplication or can find FMD virus in probang samples in simple carrier animals; nevertheless, in susceptible animals, this would be considered as a case of infection. While the Community agrees that in principle development or multiplication is consubstantial with infection, this may be difficult to prove very quickly, and will affect definition of case and also infection in specific disease chapters.

The current definition, by using the word "host", links the susceptible animal to the specific agent and thus implies that the agent "lives" i.e. multiplies. By changing it to try to improve matters, the reverse could be achieved.

The Community's opinion is to keep the current definition, or to add to the new definition the following words: ", detected in accordance with the OIE Manual of Standards".

Laying birds

means birds kept for the purpose of producing eggs not intended for hatching.

Monitoring

means the continuous investigation of intermittent performance and analysis of routine measurements, aimed at changes in the environment or health status of a given population or subpopulation , and its environment, to detect changes in the prevalence of a disease or characteristics of a pathogenic agent .

Community comments:

This definition in English seems very unclear and should be revised. At least, the word "detecting" should be added after "aimed at" and the words "and/or observations" should be added after the word “measurements”.

Official veterinary control

means that the Veterinary Services knows the location of the animals and the identity of their owner or responsible keeper and is able to apply appropriate animal health measures, as required.

Community comments:

A definition of control should remain, even if amended, in order to define the disease control strategy.

Quarantine station

means a facility place under the control of the Veterinary Services where animals are maintained in isolation with no direct or indirect contact with other animals, to prevent the transmission of specified pathogen(s) while the animals are undergoing observation for a specified length of time and, if appropriate, testing and treatment.

Community comments:

If the word "facility" might be too precise, the word "place" is too vague. The word "premises" could be a good alternative.

Risk

means the likelihood of the occurrence and the likely magnitude of the consequences of an adverse event to animal or human health in the importing country during a specified time period, as a result of a hazard .

Risk assessment

means the evaluation of the likelihood and the biological and economic consequences of entry, establishment, or and spread of a pathogenic agent hazards within the territory of an importing country .

Community comments:

The word "or" should not be deleted, as it is possible to assess the risk of introduction only for example. The word " hazard " should be written without "s" and in italic.

Sanitary measure

means any a measure applied , such as those described in various chapters of the Terrestrial Code , designed to protect animal or human health or life within the territory of the Member Country from risks arising from the entry, establishment or spread of a hazard . [Note: A detailed definition of sanitary measure may be found in the Agreement on the Application of Sanitary and Phytosanitary Measures of the World Trade Organization.

Surveillance

means the investigation of a given population or subpopulation to detect the presence of a pathogenic agent or disease ; the frequency and type of surveillance will be determined by the epidemiology of the pathogenic agent or disease , and the desired outputs the systematic ongoing collection, collation, and analysis of data and the timely dissemination of information to those who need to know so that action can be taken .

Veterinary Services

means the governmental and non-governmental organisations that implement animal health and welfare measures and other standards and guidelines in the Terrestrial Code in the country. The Veterinary Services are under the overall control and direction of the Veterinary Authority . Private sector organisations or veterinarians are normally accredited or approved to deliver functions by the Veterinary Authority .

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Annex IV

CHAPTER 1.2.1. GENERAL OBLIGATIONS

Community comments:

The Community can support the draft changes, but asks the TAHSC to take into account the few specific comments below.

Article 1.2.1.1.

Safety of I i nternational trade in animals and animal products depends on a combination of factors which should be taken into account to ensure unimpeded trade, without incurring unacceptable risks to human and animal health.

Because of differences between countries in their the likely variations in animal health situations, various options are offered by the Terrestrial Code . The animal health situation in the exporting country , in the transit country or countries and in the importing country should be considered before determining the requirements which have to be met for trade. To maximise harmonisation of the sanitary aspects of international trade , Veterinary Authorities of Member s Countries should base their import requirements on the OIE standards , and guidelines and recommendations .

These requirements should be included in the model certificates approved by the OIE which form are included in Part 4 of the Terrestrial Code .

Certification requirements should be exact and concise, and should clearly convey the wishes of the importing country . For this purpose, prior consultation between Veterinary Authorities of importing and exporting countries is useful and may be necessary. It enables the setting out of the exact requirements so that the signing veterinarian can, if necessary, be given a note of guidance explaining the understanding between the Veterinary Authorities involved.

When Members officials of a Veterinary Authority wish to visit another country for matters of professional interest to the Veterinary Authority of the other country, the latter should be informed.

Article 1.2.1.2.

Responsibilities of the importing country

28. The import requirements included in the international veterinary certificate should assure that commodities introduced into the importing country comply with the national level of protection that it has chosen for animal and human health. Importing countries should restrict their requirements to those justified for such level of protection. If these are stricter than the OIE standards, they should be based on an import risk analysis .The international veterinary certificate should not include requirements for the exclusion of pathogens or animal diseases which are present within the territory of in the importing country and are not subject to any official control programme . The requirements applying to pathogens or diseases subject to official control programmes in a country or zone should not provide a higher level of protection on imports than that provided for the same pathogens or diseases by the measures applied within that country or zone . The measures imposed on imports to manage the risks posed by a specific pathogen or disease should not require a higher level of protection than that provided by measures applied as part of the official control programme operating within the importing country .

29. The international veterinary certificate should not include requirements for disease agents measures against pathogens or diseases which are not OIE listed, unless the importing country has identified the disease agent as presenting a significant risk for that country, after conducting a scientifically based import risk analysis according o the guidelines in Section 1.3 demonstrated through import risk analysis , carried out in accordance with Section 1.3., that the pathogen or disease poses a significant risk to the importing country .

30. The transmission by the Veterinary Authority of certificates or the communication of import requirements to persons other than the Veterinary Authority of another country, necessitates that copies of these documents are also sent to the Veterinary Authority . This important procedure avoids delays and difficulties which may arise between traders and Veterinary Authorities when the authenticity of the certificates or permits is not established.

This information is usually the responsibility of Veterinary Authorities . However, it can be issued by private sector veterinarians at the place of origin of the animals when this practice is the subject of appropriate approval and authentication by the Veterinary Authority .

Article 1.2.1.3.

Responsibilities of the exporting country

31. An exporting country should , on request, be prepared to supply the following information to importing countries on request :

32. information on the animal health situation and national animal health information systems to determine whether that country is free or has free zones of listed diseases , including the regulations and procedures in force to maintain its free status;

Community comments:

Where this information on the animal health situation has been provided to the OiE for an official recognition of status , this should be enough for the importing country to avoid unnecessary duplication of work.

33. regular and prompt information on the occurrence of transmissible notifiable diseases ;

34. details of the country's ability to apply measures to control and prevent the relevant listed diseases ;

35. information on the structure of the Veterinary Services and the authority which they exercise;

36. technical information, particularly on biological tests and vaccines applied in all or part of the national territory.

37. Veterinary Authorities of exporting countries should:

38. have official procedures for authorisation of certifying veterinarians , defining their functions and duties as well as conditions covering possible suspension and termination of the appointment;

39. ensure that the relevant instructions and training are provided to certifying veterinarians ;

40. monitor the activities of the certifying veterinarians to verify their integrity and impartiality.

41. The Head of the Veterinary Service of the exporting country is ultimately accountable for veterinary certification used in international trade .

Article 1.2.1.4.

Responsibilities in case of an incident occurring after related to importation

1. International trade involves a continuing ethical responsibility. Therefore, if within the recognised incubation periods of the various diseases subsequent to an export taking place, the Veterinary Authority becomes aware of the appearance or reappearance of a disease which has been specifically included in the international veterinary certificate , there is an obligation for the Administration to notify the importing country , so that the imported stock may be inspected or tested and appropriate action be taken to limit the spread of the disease should it have been inadvertently introduced.

2. Equally, if a disease condition appears in imported stock within a time period after importation consistent with the recognised incubation period of the disease , the Veterinary Authority of the exporting country should be informed so as to enable an investigation to be made, since this may be the first available information on the occurrence of the disease in a previously free herd. The Veterinary Authority of the importing country should be informed of the result of the investigation since the source of infection may not be in the exporting country .

3. In case of suspicion, on reasonable grounds, that an official certificate may be fraudulent, the Veterinary Authority of the importing country and exporting country should conduct an investigation. Consideration should also be given to notifying any third country(ies) that may have been implicated. All associated consignments should be kept under official control, pending the outcome of the investigation. The Veterinary Authorities of all countries involved should fully cooperate with the investigation. If the certificate is found to be fraudulent, every effort should be made to identify those responsible so that appropriate action can be taken according to the relevant legislation.

Community comments:

The last sentence does not seem relevant to the Code , and should be deleted.

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Annex IV (contd)

CHAPTER 1.3.2. GUIDELINES FOR IMPORT RISK ANALYSIS

Community comments:

The Commission supports the addition of compartmentalisation in the Figure 1, but the words "zoning and" should not be deleted, as both zoning and compartmentalisation are essential. This must be corrected.

Article 1.3.2.1.

Introduction

An import risk analysis begins with a description of the commodity proposed for import and the likely annual quantity of trade. It must be recognised that whilst an accurate estimate of the anticipated quantity of trade is desirable to incorporate into the risk estimate, it may not be readily available, particularly where such trade is new.

Hazard identification is an essential step which must be conducted before the risk assessment .

The risk assessment process consists of four interrelated steps. These steps clarify the stages of the risk assessment , describing them in terms of the events necessary for the identified potential risk(s) to occur, and facilitate understanding and evaluation of the outputs. The product is the risk assessment report which is used in risk communication and risk management .

The relationships between risk assessment and risk management processes are outlined in Figure 1.

Fig. 1. The relationship between risk assessment and risk management processes

[pic]

Annex IV (contd)

Article 1.3.2.2.

Hazard identification

The hazard identification involves identifying the pathogenic agents which could potentially produce adverse consequences associated with the importation of a commodity .

The potential hazards identified would be those appropriate to the species being imported, or from which the commodity is derived, and which may be present in the exporting country . It is then necessary to identify whether each potential hazard is already present in the importing country , and whether it is a notifiable disease or is subject to control or eradication in that country and to ensure that import measures are not more trade restrictive than those applied within the country.

Hazard identification is a categorisation step, identifying biological agents dichotomously as potential hazards or not. The risk assessment may be concluded if hazard identification fails to identify potential hazards associated with the importation.

The evaluation of the Veterinary Services , surveillance and control programmes and zoning and compartmentalisation systems are important inputs for assessing the likelihood of hazards being present in the animal population of the exporting country .

An importing country may decide to permit the importation using the appropriate sanitary standards recommended in the Terrestrial Code , thus eliminating the need for a risk assessment .

Article 1.3.2.3.

Principles of risk assessment

42. 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.

43. Both qualitative risk assessment and quantitative risk assessment methods are valid.

44. 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.

45. 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.

46. Risk assessments should document the uncertainties , the assumptions made, and the effect of these on the final risk estimate.

47. Risk increases with increasing volume of commodity imported.

48. The risk assessment should be amenable to updating when additional information becomes available.

Article 1.3.2.4.

Risk assessment steps

49. 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:

50. Biological factors

51. species, age and breed of animals

52. agent predilection sites

53. vaccination, testing, treatment and quarantine.

54. Country factors

55. incidence/prevalence

56. evaluation of Veterinary Services , surveillance and control programmes and zoning systems of the exporting country .

57. Commodity factors

58. quantity of commodity to be imported

59. ease of contamination

60. effect of processing

61. effect of storage and transport.

If the release assessment demonstrates no significant risk , the risk assessment conclude.

62. 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:

63. Biological factors

64. properties of the agent.

65. Country factors

66. presence of potential vectors

67. human and animal demographics

68. customs and cultural practices

69. geographical and environmental characteristics.

70. Commodity factors

71. quantity of commodity to be imported

72. intended use of the imported animals or products

73. disposal practices.

If the exposure assessment demonstrates no significant risk , the risk assessment may conclude at this step.

74. 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:

75. Direct consequences

76. animal infection , disease , and production losses

77. public health consequences.

78. Indirect consequences

79. surveillance and control costs

80. compensation costs

81. potential trade losses

82. adverse consequences to the environment.

83. Risk estimation

Risk estimation consists of integrating the results from the release assessment, exposure assessment, and consequence assessment to produce overall measures of risks associated with the hazards identified at the outset. Thus risk estimation takes into account the whole of the risk pathway from hazard identified to unwanted outcome.

For a quantitative assessment, the final outputs may include:

- estimated numbers of herds, flocks, animals or people likely to experience health impacts of various degrees of severity over time;

- probability distributions, confidence intervals, and other means for expressing the uncertainties in these estimates;

- portrayal of the variance of all model inputs;

- a sensitivity analysis to rank the inputs as to their contribution to the variance of the risk estimation output;

- analysis of the dependence and correlation between model inputs.

Article 1.3.2.5.

Principles of risk management

84. Risk assessment is the process of deciding upon and implementing measures to achieve the Member Country's appropriate level of protection, whilst at the same time ensuring that negative effects on trade are minimised. The objective is to manage risk appropriately to ensure that a balance is achieved between a country's desire to minimise the likelihood or frequency of disease incursions and their consequences and its desire to import commodities and fulfil its obligations under international trade agreements.

85. The international standards of the OIE are the preferred choice of sanitary measures for risk management . The application of these sanitary measures should be in accordance with the intentions in the standards.

Article 1.3.2.6.

Risk management components

86. Risk evaluation - the process of comparing the risk estimated in the risk assessment with the Member Country's appropriate level of protection.

87. Option evaluation - the process of identifying, evaluating the efficacy and feasibility of, and selecting measures in order to reduce the risk associated with an importation in line with the Member Country's appropriate level of protection. The efficacy is the degree to which an option reduces the likelihood and/or magnitude of adverse health and economic consequences. Evaluating the efficacy of the options selected is an iterative process that involves their incorporation into the risk assessment and then comparing the resulting level of risk with that considered acceptable. The evaluation for feasibility normally focuses on technical, operational and economic factors affecting the implementation of the risk management options.

88. Implementation - the process of following through with the risk management decision and ensuring that the risk management measures are in place.

89. Monitoring and review - the ongoing process by which the risk management measures are continuously audited to ensure that they are achieving the results intended.

Article 1.3.2.7.

Principles of risk communication

1. Risk communication is the process by which information and opinions regarding hazards and risks are gathered from potentially affected and interested parties during a risk analysis , and by which the results of the risk assessment and proposed risk management measures are communicated to the decision-makers and interested parties in the importing and exporting countries . It is a multidimensional and iterative process and should ideally begin at the start of the risk analysis process and continue throughout.

2. A risk communication strategy should be put in place at the start of each risk analysis .

3. The communication of the risk should be an open, interactive, iterative and transparent exchange of information that may continue after the decision on importation.

4. The principal participants in risk communication include the authorities in the exporting country and other stakeholders such as domestic and foreign industry groups, domestic livestock producers and consumer groups.

5. The assumptions and uncertainty in the model, model inputs and the risk estimates of the risk assessment should be communicated.

6. Peer review is a component of risk communication in order to obtain scientific critique and to ensure that the data, information, methods and assumptions are the best available.

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