25

*Original: English*

*September 2021*

**REPORT OF THE MEETING OF THE OIETERRESTRIAL ANIMAL HEALTH STANDARDS COMMISSION**

**Virtual meeting, 7–16 & 23 September 2021**

**________**

The OIE Terrestrial Animal Health Standards Commission (the Code Commission) held its meeting electronically from 7 to 16, and 23 September 2021. The list of participants is attached as **Annex 1**.

The Code Commission thanked the following Members and partner organisations for providing comments on its February 2021 report: Argentina, Australia, Brazil, Burkina Faso, Cameroon, Canada, China (People’s Republic of), Japan, New Zealand, Norway, Singapore, South Africa, Thailand, the United Kingdom (UK), the United States of America (USA), Members of the OIE Asia, Far East and Oceania Region, the African Union Interafrican Bureau for Animal Resources (AU-IBAR) on behalf of African Member Countries of the OIE, Members of the OIE Americas Region, the Comité Veterinario Permanente del Cono Sur (CVP) on behalf of Argentina, Bolivia, Brazil, Chile, Paraguay and Uruguay, the Member States of European Union (EU), the International Coalition for Farm Animal Welfare (ICFAW), and the World Renderers Organization (WRO).

The Code Commission reviewed the Member comments that were submitted on time and supported by a rationale, and amended relevant texts, as appropriate. The Commission did not consider comments where a rationale had not been provided or that were unclear and difficult to interpret. Due to the large volume of work, the Commission did not provide a detailed explanation for accepting or not each of the comments and focused its explanations on the major comments. Where amendments were of an editorial nature, no explanatory text has been provided. The Commission wished to note that not all texts proposed by Members to improve clarity were accepted; in these cases, it considered the text clear as currently written.

Amendments to new or revised text of the OIE *Terrestrial Animal Health**Code* (the *Terrestrial Code*) are presented in the usual manner by ‘double underline’ and ‘~~strikethrough~~’, and the texts are annexed to this report. In previously circulated texts, new amendments proposed at this meeting are highlighted with a coloured background to distinguish them from those proposed previously. 

The Code Commission encouraged Members to refer to previous reports for longstanding issues. The Commission also draws the attention of Members to where the Scientific Commission for Animal Diseases (the Scientific Commission), the Biological Standards Commission (the Laboratories Commission), a Working Group or an *ad hoc*Group have addressed specific comments or questions and proposed answers or amendments. In such cases, the rationale is described in the relevant report of these expert groups and Members are encouraged to review these reports together with the report of the Code Commission. These reports are available on the OIE website. 

Members should note that texts in **Part A (Annexes 4 to 18)** of this report are circulated for Member comments and will be proposed for adoption at the 89th General Session in May 2022. **Part B****(Annex 19 )**are texts circulated for Member comments only. 

All comments on relevant texts in **Part A**and**Part B** must reach OIE Headquarters **by 27 December 2021**for them to be considered by the Code Commission at its February 2022 meeting. Comments received after the due date will not be submitted to the Code Commission for its consideration. In addition, the Code Commission would like to highlight that comments should be submitted through the OIE Delegate of Member Countries or organisations which the OIE has a Cooperative Agreement with. 

All comments should be sent to the OIE Standards Department at **TCC.Secretariat@oie.int******no later than**27 December 2021**. 

The Code Commission strongly encourages Members to participate in the development of the OIE’s international standards by submitting comments on this report. Members are also reminded that comments should be submitted as Word files rather than pdf files because pdf files are difficult to incorporate into the working documents of the Code Commission. Comments should be submitted as specific proposed text changes, supported by a rationale including scientific references, if relevant. Proposed deletions should be shown using ‘~~strikethrough~~’ and additions using ‘double underline’. Members should not use the automatic ‘track-changes’ function provided by word processing software as such changes are lost in the process of collating submissions into the Code Commission’s working documents. Members are also requested **not** to reproduce the full text of a chapter while preparing comments as this is difficult for the Secretariat.

Table of Contents:

1.	Welcome from the Deputy Director General

Dr Matthew Stone, OIE Deputy Director General International Standards and Science (DDG ISS), welcomed the Code Commission and congratulated members on their election. Dr Stone together with Dr Gillian Mylrea, Head of the Standards Department, conducted an induction session at the start of the meeting. This was the final session of the Specialist Commission induction programme that had been implemented as part of the Performance Management System. In previous months induction sessions had been conducted for new Commission members, Presidents and all Commission members and Secretariats to meet each other and share information relevant to this new term.

During this induction session, Dr Stone presented for the consideration of members a discussion on managing the workload, roles and responsibilities, process innovation, and the performance management system. 

Dr Stone recalled that the February 2021 Commission reports had been produced in two parts, A (texts for adoption) and B (texts for comments and information) to ensure early publication of texts that were to be proposed for adoption ahead of the virtual General Session. He noted that the OIE will continue with this approach in 2022. Dr Stone also recalled that Pre-General Session webinars hosted by Commission members to explain the standards being proposed for adoption were well received and will be repeated in future. Dr Stone also encouraged Commission members to conduct webinars in their respective regions for Delegates and relevant Focal Points after the September meeting to explain decisions made. He acknowledged that these webinars would also provide a good way for members to build their networks.

Dr Stone recalled that the proposed new Chapter 7.Z. Animal welfare and laying hen production systems had not been adopted during the 2021 General Session and noted that a number of Members and partner organisations had submitted comments in response to this outcome. Dr Stone indicated that the OIE was exploring a number of different options to find ways to address this very important topic. He indicated that the OIE would discuss possible options with the Code Commission at its February 2022 meeting. 

The members of the Code Commission thanked Dr Stone for this informative presentation. With respect to the laying hens draft chapter, the Commission noted that the decision of the Assembly is part of the standard-setting process and that the Commission will support the OIE to find an approach that meets Member’s expectations. 

The members of the Code Commission thanked Dr Stone and acknowledged the excellent support provided to them by the OIE Secretariat.

Dr Mylrea facilitated a short session on agreed ways of working in which members discussed expectations around behaviour and how they would like to work as a group in the coming three years. The President also shared with the members his expectations for the new term.

2.	Meeting with the Director General

Dr Monique Eloit, the OIE Director General, met the Code Commission on 14 September 2021 and congratulated the new and re-elected members of the Commission. Dr Eloit provided an update on progress in the implementation of the 7th OIE Strategic Plan and highlighted one example of new work that will be undertaken to assess the OIE science system including OIE Reference Centres and expertise in OIE *ad hoc* Groups, Working Groups, and how the OIE can ensure the best use of these networks of experts. Dr Eloit also acknowledged the large workload of the Commission and highlighted that prioritisation of its work programme is critical during this coming period and highlighted that quality of the work is more important than quantity. 

The members of the Code Commission congratulated Dr Eloit for her election for a second term as OIE Director General and expressed the commitment of the Commission to support the achievement of OIE objectives, and specially concurred with favouring quality over quantity in the work programme. Dr Bonbon highlighted some key areas of work that would be prioritised for this new term, notably the need to review some key chapters in Section 5 of the *Terrestrial Code*. 

3.	Adoption of agenda

The proposed agenda was discussed and adopted, taking into consideration the priorities of the work programme and time availability. It is presented in **Annex 2**.

Due to time constraints, the Code Commission did not discuss agenda items 5.1.7. Infection with Mycobacterium tuberculosis complex (Chapter 8.11.); 5.1.8. Infection with equine influenza virus (Chapter 12.6.); 5.1.11. Harmonisation of official recognition of status by the OIE: contagious bovine pleuropneumonia (Chapter 11.5.); 5.1.12. Mers Cov; 5.1.13. Leishmaniosis; 5.1.14.2. Use of terms ‘epizootics/epidemics’, ‘enzootic/endemic’ and ‘pandemic’; 5.1.15. Pet food as safe commodities; 5.1.16. Honey – definitions and provisions on importation; and 7.2.6. Contagious equine metritis (Chapter 12.2.). The Commission agreed to postpone these items until a future meeting.

4.	Cooperation with other Specialist Commissions

4.1.	Scientific Commission for Animal Diseases

The OIE Secretariat updated the Code Commission on relevant ongoing activities of the Scientific Commission. The Scientific Commission, at its September 2021 meeting, will consider a number of topics relevant to the Code Commission’s work programme, and will provide its opinions on a number of points regarding Chapter 8.14. Infection with rabies virus; Chapter 8.15. Infection with Rift Valley fever virus; Chapter 12.7. Equine piroplasmosis; and Chapter 8.X. and Chapter 12.3. on Surra and dourine. The Code Commission, at its February 2022 meeting, will consider the opinion of the Scientific Commission together with other pending issues, in order to progress work on the revision of these chapters.

The Code Commission was provided with an update on the progress of the work to develop case definitions to support notification being conducted by the Scientific Commission. In response to this update, the Code Commission recognised the value of this work and reminded Members that in order to support notification, newly developed case definitions of listed diseases would be published on the OIE Website if they do not conflict with existing OIE Standards. These case definitions would then be considered for inclusion in the relevant disease-specific chapter of the *Terrestrial Code* according to the prioritisation of the Code Commission’s work programme and the standard-setting process. 

The Code Commission acknowledged the rationale provided in the Scientific Commission’s February 2021 report that chronic wasting disease does not meet the criteria for listing, specifically for point 2 of Article 1.2.2. of Chapter 1.2. Criteria for the inclusion of diseases, infections and infestations in the OIE list. The Commission also noted that the Scientific Commission will consider the expert consultation reports and the opinion of the Laboratories Commission on assessments undertaken for paratuberculosis and West Nile virus in accordance with Chapter 1.2.

The Code Commission wished to thank the Scientific Commission for its collaborative work in providing opinions to support the consideration of relevant Member comments received. The Code Commission reminded Members that its consideration of the Scientific Commission contributions is noted under the relevant agenda items of this report and encouraged Members to read this report together with the September 2021 Scientific Commission report.  

4.2.	Biological Standards Commission

The OIE Secretariat provided an  update to the Code Commission on relevant activities of the Laboratories Commission, including recently adopted chapters and those under review in the *Manual of Diagnostic Tests and Vaccines for Terrestrial Animals* (the *Terrestrial Manual*).

The Code Commission considered and discussed the following items relevant to its work programme in relation to work being undertaken by the Laboratories Commission:

· Infection with *Theileria* in small ruminants**(Chapter 14.X.): the Code Commission was informed that the Laboratories Commission will be considering a new draft c**at its September 2021 meeting. The Code Commission agreed it will recommence work on the *Terrestrial Code* draft Chapter 14.X. once the revised *Terrestrial Manual* chapter has been adopted.

· The change of taxonomic name for ‘Newcastle disease virus’: as reported in the Laboratories Commission’s September 2020 report, the Laboratories Commission had proposed to change the name of avian paramyxovirus serotype 1 (APMV-1) to avian orthoavulavirus 1 (AOAV-1) in Chapter 3.3.14. of the *Terrestrial Manual*. However, the Laboratories Commission, at its February 2021 meeting, agreed not to propose this change in the revised draft chapter for adoption after considering several Member comments. To ensure alignment with the corresponding Chapter 10.9. Infection with Newcastle disease virus in the *Terrestrial**Code*, the Code Commission agreed to not make any changes in the current text and to remove this item from its work programme.

4.3.	Aquatic Animals Health Standards Commission

The Code Commission and the Aquatic Animals Health Standards Commission (Aquatic Animals Commission) continued to work together to coordinate their respective work on the revision of the glossary definitions for Competent Authority, Veterinary Authority and Veterinary Services in the *Terrestrial Code* with the Glossary definitions for Competent Authority, Veterinary Authority and Aquatic Animal Health Services in the OIE *Aquatic Animal Health**Code* (the *Aquatic Code*), noting the importance of ensuring alignment of these definitions, except where differences could be well justified (see item 6.1. of this report for more details).

As part of the discussion of the next steps for the revision of Section 4 of the *Terrestrial Code*, the OIE Secretariat provided the Code Commission with a summary report of relevant work completed or planned by the Aquatic Animals Commission. The Code Commission appreciated this information and acknowledged that some of the work of the Aquatic Animals Commission would be helpful for its work given that many of the topics addressed in Section 4 are relevant for both the aquatic and terrestrial domains (refer to item 5.1.1. of this report for more details).

The Code Commission also discussed the need for a review of some chapters in Section 5 and the importance of coordinating this work with parallel work being considered by the Aquatic Animals Commission (refer to item 5.1.3. of this report for more details).

The Code Commission discussed with the OIE Secretariat the need to establish a robust exchange mechanism between the two Commissions for a closer follow up of relevant items in their respective work programmes. 

5.	Code Commission’s work programme 

Comments were received from the EU.

The Code Commission discussed ongoing priority topics on its work programme and pending issues with recently adopted chapters and considered comments and new requests received. The Commission noted that in general, few Members submit comments on the work programme, which outlines the work areas, current and planned, to be undertaken by the Commission. The Commission strongly encouraged Members to provide feedback as to whether they agree with the topics being proposed, as well as their level of prioritisation.

5.1.	Ongoing priority topics 

The Code Commission discussed the progress of a number of ongoing priority topics for which no new or revised text is circulated in this report as below.

**5.1.1.	Revision of Section 4 Disease prevention and control**

Background

The Code Commission had agreed to develop a number of new chapters and to revise some existing chapters of Section 4. Disease prevention and control. To date, a new Chapter 4.18. Vaccination was adopted in 2018, and a revised Chapter 4.4. Zoning and compartmentalisation and a new Chapter 4.19. Official control programmes for listed and emerging diseases were adopted in 2021. Work to revise Chapter 4.6. General hygiene in semen collection and processing centres and Chapter 4.7. Collection and processing of bovine, small ruminant and porcine semen is in progress.

Discussion

The OIE Secretariat presented a summary of the current status of the revision of Section 4, including comments received previously. Taking this into account, the Code Commission reviewed Section 4 and agreed that in addition to the ongoing work to revise Chapters 4.6. and 4.7., high priority should also be given to the revision of Chapter 4.13. Disposal of dead animals and Chapter 4.14. General recommendations on disinfection and disinsection as well as to the development of a new chapter on biosecurity.

The Code Commission made the following comments regarding the scope of the chapters:

**a)	Revision of Chapter 4.13. Disposal of dead animals**

The Code Commission considered that this chapter should not be limited to dead animals but also address all potentially contaminated wastes/products/fomites. 

**b)	Revision of Chapter 4.14. General recommendations on disinfection and disinsection**

The Code Commission had included the revision of Chapter 4.14. in its work programme since February 2017, acknowledging that the chapter needed revision to address disinfection in more detail. The Commission noted that a new Chapter 4.1. Disinfection of aquaculture establishments and equipment of the *Aquatic Code*was adopted**in 2016 and could provide some guidance for the revision of Chapter 4.14. of the *Terrestrial Code*.

The Code Commission noted that Chapter 4.14. is cross-referenced in many parts of the *Terrestrial Code*, including the Glossary definition for ‘stamping-out policy’ and a range of articles on recovery of free status in disease-specific chapters. The Commission also acknowledged that it had received a comment to amend the Glossary definition for ‘disinfection’ to allow ‘fallowing’ to be covered as a disinfection method and noted that the need to revise relevant Glossary definitions would be considered in this work.

**c)	Development of a new chapter on biosecurity**

The development of a new chapter on biosecurity was first included in the Code Commission’s work programme in September 2017, acknowledging that biosecurity is fundamental to disease prevention and control and should be addressed in the *Terrestrial Code*. The Commission also noted that a new chapter on biosecurity for aquaculture establishments in the *Aquatic Code* was adopted in 2021 and this could provide some guidance for this new chapter.

The Code Commission also noted that some chapters in the *Terrestrial Code* and some guidelines developed by other organisations provide some specific recommendations on components of biosecurity to be covered in the new chapter. Moreover, the Commission explained that its work on a definition for swill would be addressed as part of this work (refer to the February 2021 Commission report for more details).

The Code Commission also reminded that it was in the process of revising the use of the word ‘biosecurity’ across the *Terrestrial Code*, and therefore that work would also be related to the development of this new chapter.

The Code Commission requested the OIE Secretariat to prepare terms of reference for these revisions and development, including scope, expertise needed and tentative timeframe, and to report back at its next meeting.

**5.1.2.	Work of the *ad hoc* Group on the Revision of *Terrestrial Code* chapters regarding the collection and processing of semen of animals**

Background 

At its September 2019 meeting, the Code Commission requested that an *ad hoc* group be convened to revise Chapter 4.6. General hygiene in semen collection and processing centres and Chapter 4.7. Collection and processing of bovine, small ruminant and porcine semen, as well as provisions in relevant disease-specific chapters of the *Terrestrial Code* and the *Terrestrial**Manual*. This work had been requested to resolve inconsistencies among the chapters and to ensure that the texts reflected the latest scientific evidence and best practices regarding risk mitigation measures in the collection and processing of semen of animals. The *ad hoc* Group was also requested to consider the inclusion of provisions to address equine semen in these chapters. 

The first meeting of the *ad hoc* Group took place virtually between November–December 2020. The *ad hoc* Group agreed to work on Chapter 4.6. first before starting work on Chapter 4.7. and proposed a revised structure for Chapter 4.6. At its February 2021 meeting, the Code Commission endorsed the work of the *ad hoc* Group and provided further guidance on the holdings and species to be covered in the chapter. 

Update

The *ad hoc* Group met for the second time between May–July 2021 and further developed draft text for Chapter 4.6. 

The Code Commission reviewed the *ad hoc* Group’s report and commended the *ad hoc* Group for its work. The Commission supported the *ad hoc* Group’s recommendation to consult species-specific experts for further information regarding entry protocols, accommodation conditions and general hygiene that should be applied during the collection of semen, notably for equids and cervids. 

The Code Commission supported the proposal of the OIE Secretariat to continue the review of Chapter 4.6. by engaging an expert who will work closely with the Secretariat and a representative of the Commission to further develop the draft text prepared by the *ad hoc* Group, also taking into consideration the advice of the Commission, and to incorporate recommendations from species-specific experts. The Commission agreed that the revised draft text should then be presented to the *ad hoc* Group for comment before being presented to the Commission at a future meeting.

The Code Commission encouraged Members to read the report of the OIE *ad hoc* Group on the Revision of *Terrestrial Code* chapters regarding the collection and processing of semen of animals available on the OIE Website (https://www.oie.int/en/what-we-do/standards/standards-setting-process/ad-hoc-groups/).

**5.1.3.	Revision of Section 5 Trade measures, import/export procedures and veterinary certification**

Background

The Code Commission included the review of Section 5 of the *Terrestrial Code* on Trade measures, import/export procedures and veterinary certification in its work programme in September 2017, acknowledging that some of the chapters have not been updated for some time and may not be adequate to support Members in managing the risks of introduction of diseases through the importation of commodities.

Discussion 

The OIE Secretariat presented to the Code Commission a summary of previous discussions, including comments received previously from Members. Taking this into account, the Commission reviewed the current content of Section 5 and agreed that a revision of Chapters 5.4. to 5.7. should be given priority.

The Code Commission highlighted that the revision of these four chapters (Chapters 5.4., 5.5., 5.6. and 5.7.) should address the entire process of international trade, including measures at origin, in transit, and on arrival. The Commission noted that both live animals and animal products would be addressed.

Recognising that Section 5 of the *Terrestrial Code* and *Aquatic**Code* have many similarities in content and structure and that overarching principles should continue to be aligned between the two *Codes*, the Code Commission requested that this work be done in close collaboration with the Aquatic Animals Commission. 

The Secretariat informed the Code Commission that the Codex had proposed draft guidance on paperless use of electronic certificates, which will be considered for adoption at Step 5 by the 44th Codex Alimentarius Commission (2021) and that the OIE is currently considering its future work on this topic. The Commission noted the importance of e-certification and agreed that e-veterinary certification should also be taken into consideration as part of the review of Section 5.

The Code Commission also discussed other related topics which could be considered during this revision such as risks posed by illegal or informal cross-border trade of commercial and non-commercial animal products, including products delivered via postal or courier services. It also noted that the pathway of waste from international air and seaports could also be considered as part of the revision of relevant chapters (this would also be linked with the new chapter to be developed on biosecurity).

The Code Commission proposed that the OIE Secretariat develop the scope of this work and terms of reference including expertise needed and tentative timeframe, which the Commission will consider at its next meeting.

**5.1.4.	Responsible and prudent use of antimicrobial agents in veterinary medicine (Chapter 6.10.)**

Background

At its February 2019 meeting, the Code Commission agreed to include in its work programme, a review of Chapter 6.10. Responsible and prudent use of antimicrobial agents in veterinary medicine, in response to comments received as well as in light of the revision of some definitions in Chapter 6.9. Monitoring of the quantities and usage patterns of antimicrobial agents used in food-producing animals, adopted in 2018, that could have an impact on Chapter 6.10. The Commission had requested the advice of the OIE Working Group on Antimicrobial Resistance. The Working Group considered this request at its 2019 meeting and recommended that amendments to Chapter 6.10. not be undertaken until work of the Codex Alimentarius Task Force on Antimicrobial Resistance (TFAMR) had progressed, in order to avoid duplication and inconsistencies.

At its February 2021 meeting, the Code Commission was informed that the Codex Code of Practice to Minimize and Contain Foodborne Antimicrobial Resistance (CXC 61-2005) had been adopted at Step 5 at the Codex Alimentarius Commission meeting in November 2020. Noting the progress being made by Codex, the Commission asked that the Working Group provide their views on the review of Chapter 6.10., including expanding the scope of the chapter to non-food producing animals, identifying the main areas of the chapter that would benefit from an update, and the best way to progress this work.

Update 

The Code Commission was informed that the report of the 43rd Session of the Codex Alimentarius Commission (CAC43) noted that following a procedural schedule to finalise the work to revise the Codex Code of Practice to Minimize and Contain Foodborne Antimicrobial Resistance (after a further round of comments (at Step 6), and finalisation by the TFAMR (at Step 7, in October 2021), the text would be proposed for adoption at Step 8 at the CAC44 to be held in November 2021.

The Code Commission was informed that the Working Group, at its April 2021 meeting, had considered the Commission’s request and identified the main areas that it considered should be updated. The Working Group highlighted that given the current chapter is not limited to food producing animals, some additional references to companion animals, such as responsibilities of owners of companion animals, could be considered for inclusion. The Working Group also noted that the addition of elements relating to the environment, although important in the context of AMR, may be outside of the scope of this chapter which is included in Section 6. Veterinary Public Health of the *Terrestrial Code*.

The Code Commission agreed that it would be beneficial to consider explicitly expanding the scope of Chapter 6.10. to companion and leisure animals, and considered that the addition of elements relating to the environment was within the scope of this chapter given that the circulation of antimicrobial agents from veterinary medicinal products and AMR bacteria from animals in the environment may impact animal and public health.

The Code Commission proposed for the Working Group to be asked to review and revise Chapter 6.10. and also to consider whether the other AMR chapters (Chapters 6.7., 6.8., 6.9., and 6.11.) would need to be amended as a consequence of the revision of Chapter 6.10.

The Code Commission commended the Working Group for its advice and willingness to revise the chapter and encouraged Members to refer to the Working Group’s April 2021 report that presents details about its considerations.

**5.1.5.	Revision of animal welfare chapters on transport of animals by land, sea and air (Chapters 7.2., 7.3. and 7.4.)**

The OIE Secretariat presented a proposal to the Code Commission for the revision of the three chapters on animal transport to address gaps in the current scientific knowledge, to reduce duplication and inconsistencies and to improve syntax and layout.

The Code Commission agreed that it was important to review these chapters to ensure they reflect current scientific approaches, in particular the use of animal-based measures to help  animal welfare assessment and acknowledged that this would be a large piece of work. The Commission requested the OIE Secretariat to review the current chapters to determine what articles would need reviewing and the extent of work required to address these issues. The Commission asked the Secretariat to present  an analysis at its February 2022 meeting so it could discuss how to prioritise this work amongst other items on its work programme.

**5.1.6.	Slaughter of animals (Chapter 7.5.)**

Background 

In February 2018, the Code Commission agreed to revise Chapter 7.5. Slaughter of animals and Chapter 7.6. Killing of animals for disease control purposes and requested that an *ad hoc* Group be convened to undertake this work. The *ad hoc* Group met in person and virtually on several occasions since February 2018 to undertake a comprehensive review, starting with Chapter 7.5. The *ad hoc* Group considered Member comments received on a new proposed structure and on articles related to free-moving animals arriving at the slaughterhouse that were circulated for comments in the Commission’s September 2019 report. In 2020, the *ad hoc* Group was reconvened to finalise the new draft articles related to animals arriving at the slaughterhouse in containers. A revised draft chapter was circulated for comments in the Commission’s February 2021 report.

Discussion 

The Code Commission reviewed comments and requested that the *ad hoc* Group be reconvened to consider these and amend the draft chapter, as appropriate. The Commission also requested that the *ad hoc* Group:

‒	review the layout and structure of the two categories: ‘free moving animals’ and ‘animal arriving in containers’ and discuss an alternative approach to avoid duplication and improve readability;

‒	discuss options to include information on specific parameters to use for the different stunning methods recommended in the chapter;

‒	discuss the feasibility to include references to documents from other international organisations.

The Commission requested an update at its February 2022 meeting. 

**5.1.7.	Scrapie (Chapter 14.8.)**

Background

Given that a revision of Chapter 14.8. Scrapie has been on the Code Commission’s work programme for many years, the Code Commission, at its February 2021 meeting, requested the OIE Secretariat to collate all pending issues and to report back to the Commission at this meeting so it could consider a way forward.

Update

The OIE Secretariat presented a summary of previous discussions of the Code Commission and the Scientific Commission on this chapter, including Member comments received since 2011 when the most recent update of this chapter was last adopted.

The Code Commission acknowledged that the Members’ requests covered a broad range of issues, including testing for genetic resistance to scrapie as valid methods for ensuring safe trade, provisions for surveillance to demonstrate freedom, and requests to review the articles on trade of sheep/goats, semen, embryos, milk, among others.

The OIE Secretariat informed the Code Commission that the revision of Chapter 3.8.11. on ‘Scrapie’ in the *Terrestrial Manual* had been included in the Laboratories Commission list for review in its 2021/2022 review cycle and that the Laboratories Commission would consider a draft revised chapter at its September 2021 meeting.

The Code Commission noted that the main pending issue was the assessment of scrapie against the listing criteria in accordance with Chapter 1.2., as reported in the September 2014 report of the Scientific Commission. The Code Commission agreed that this assessment should be considered before starting any work on Chapter 14.8. in the *Terrestrial**Code*.

In line with the Standard Operating Procedure for listing decisions for pathogenic agents of terrestrial animals, the Code Commission requested that the assessment of the pathogenic agent against the criteria for inclusion in the OIE List be presented to the OIE DDG ISS for consideration. 

**5.1.8.	Framework for *Terrestrial Code* standards**

The OIE Secretariat updated the Code Commission on the progress of the work to develop a framework for the development of disease-specific chapters of the *Terrestrial Code* discussed at its February 2021 meeting. The Commission agreed to continue to work with the OIE Secretariat to progress this work and to review progress at its next meeting.

**5.1.9.	Safe commodities Standard Operating Procedure**

Following a discussion at the Code Commission’s February 2021 meeting, the OIE Secretariat presented a draft Standard Operating Procedure (SOP) to be applied internally when assessing commodities for inclusion in the lists of safe commodities in disease-specific chapters of the *Terrestrial Code*. The Code Commission agreed with the proposed approach and requested the OIE Secretariat to apply the draft SOP when assessing some of the safe commodities being proposed for inclusion in the Code to check that it is fit for purpose. The Commission requested that the Secretariat report back to its next meeting whether the draft SOP requires any further edits.

5.2.	Follow-up of recently adopted chapters

The Code Commission discussed specific issues raised in the context of the 88th General Session on a number of texts that were adopted at that General Session. The Commission considered the need and added value of introducing new amendments to recently adopted texts. 

The Code Commission reminded Members that all texts adopted at the 88th General Session had undergone an extensive commenting and review process, where Members had several opportunities to comment and propose modifications, including those of an editorial nature. Given this process, the Commission agreed that reopening recently adopted texts immediately after adoption should be exceptional and be limited to critical issues. The Commission considered some additional comments on the following chapters which had been adopted at the 88th General Session:

· *Introduction to recommendations on Veterinary Services (Chapter 3.1.) and Quality of Veterinary Services (Chapter 3.2.)*

The Code Commission followed up on a comment discussed at its February 2021 meeting that was raised again during the 88th General Session on the need to develop a definition for ‘One Health’ in the context of the *Terrestrial Code* (refer to item 6.2. of this report).

· *Veterinary legislation (Chapter 3.4.)*

The Code Commission considered and agreed with a comment to amend the wording of point (b) of Article 3.4.11. for clarity (refer to item 6.3. of this report). Concerning a comment requesting to include a specific reference to storage of veterinary medicinal products in the same point, the Commission agreed that it was unnecessary as storage was necessarily a part of other processes such as manufacture, wholesale and retail.

· *Containment zone (Article 4.4.7.)*

The Code Commission agreed with a comment to consider amending the text of Article 4.4.7. to clarify that a time limit should be defined for a containment zone. The Code Commission referred to a similar proposal by the Scientific Commission that had been discussed at the Code Commission’s February 2021 meeting. The Code Commission discussed possible ways to address this request and shared a proposed amended text with the Scientific Commission for its consideration. 

· *Official control programmes for listed and emerging diseases (Chapter 4.19.)*

The Code Commission considered a request to amend the second paragraph of Article 4.19.1. to note that ‘official control programmes’ should be continually reviewed. The Commission agreed with the importance of systematic review but did not agree to amend the text noting that this point was already covered in the last paragraph of this article and also in Article 4.19.13.

The Code Commission noted several comments of an editorial nature and agreed that as none were critical to the understanding of the text and that these adopted texts had been circulated for comment on several occasion, no amendments would be made. 

· *Infection with Trypanosoma brucei, T.congolense, T.simiae and T.vivax (Chapter 8.18.)*

In response to a request to include rendered products such as tallow and meat-and-bone meal as safe commodities in Article 4.19.2. given that there is no scientific evidence that these products are not safe for trade, the Code Commission first clarified that this apparent absence of evidence does not constitute evidence that these products are safe and an assessment against the criteria in Chapter 2.2. should be conducted. In addition, the Commission proposed that ‘protein meal’ be assessed as a safe commodity if its proposal to replace ‘meat-and-bone meal’ with ‘protein meal’ in the Glossary (refer to item 6.8. of this report) is adopted.

In response to a request for specific data on genera of species of competent vectors for disease-specific chapters of vector-borne diseases, such as Chapter 8.18., the Code Commission reminded Members that it had provided an explanation to a similar comment in its February 2021 report that it was not always possible to provide a detailed list of competent vectors for every disease and that such a list could even vary by region. The Code Commission highlighted that competency of vectors for OIE listed diseases, infections and infestations are regularly considered by the Scientific Commission and Laboratories Commission. The Code Commission also noted that the Scientific Commission had acknowledged inconsistencies in the requirements for disease freedom for some vector-borne disease chapters, including demonstrating the absence of competent vectors. The Code Commission noted that this issue would be considered when new chapters are developed or reviewed.

· *Infestation with Aethina tumida (Small hive beetle) (Article 9.4.5.)*

In response to comments on the appropriate geographical radius where no apiary has been subject to any restrictions associated with the occurrence of infestation with *A. tumida*, the Code Commission clarified that Article 9.4.5. describes the measures for the safe trade of live bees and points 2 and 3 address bees originating from countries or zones not free from *A. tumida.*These provisions should not be interpreted as requirements for a country or zone to be considered free from *A. tumida.*The recommended 50-km radius was deemed sufficient not as a standalone risk mitigation measure, but in conjunction with systems operating in the exporting country related to its animal health management and implementation of sanitary measures, including surveillance, movement restrictions and disease control measures.

· *Infection with high pathogenicity avian influenza viruses (Chapter 10.4.)*

The Code Commission considered a request to review point 3 of Article 10.4.1. regarding the occurrence of specific low pathogenicity avian influenza (LPAI) subtypes with zoonotic potential. The Commission noted that this issue had been extensively discussed during the revision of the chapter and that the *ad hoc* Group had clearly explained that it was not possible to identify or predict the potential zoonotic behaviour of avian influenza viruses, and that the zoonotic strains of LPAI had been addressed by adding to the OIE list a new entity: ‘Infection of domestic and captive wild birds with low pathogenicity avian influenza viruses having proven natural transmission to humans associated with severe consequences’. The Commission agreed not to amend this point.

· *Infection with peste des petits ruminants virus (Chapter 14.7.)*

The Code Commission noted the recent publication of the ‘FAO/OIE Guidelines for the Control and Prevention of Peste des Petits Ruminants (PPR) in Wildlife Populations (2021)’, aimed at supporting countries in the development and implementation of PPR eradication programmes, including facilitating the integration of the wildlife sector into the national strategic plan. 

In light of this publication, the Code Commission requested the OIE Secretariat to assess, in coordination with the Scientific and Laboratories Commissions, whether additional changes pertaining to wildlife, including incorporating wildlife into the case definition in the chapter, should be considered for Chapter 14.7. The Commission agreed that it would consider a comment to specify the precise reference for Article 1.4.6. regarding historical freedom in Article 14.7.3.when the chapter is next reviewed.

· *Infection with classical swine fever (Chapter 15.2.)*

The Code Commission noted a comment concerning point 6 of Article 15.2.3. regarding the use of vaccination in a country or zone claiming historical freedom, and the lack of specific recommendations on surveillance of vaccinated populations in the chapter. The Commission explained that as there were currently no means to distinguish between vaccinated and infected pigs in accordance with the *Terrestrial Manual*, point 6 may only be satisfied by countries or zones that do not carry out vaccination. The Commission agreed to not modify this chapter at this time and clarified that provisions on surveillance of vaccinated populations would be developed when a reliable means of DIVA is included in the *Terrestrial Manual*.

5.3.	New proposals / requests

**5.3.1.	Request from OIE Working Group on Wildlife: Surveillance of disease of wildlife**

The OIE Secretariat provided the Code Commission with an update regarding the Working Group on Wildlife’s proposal to develop a new chapter in the *Terrestrial Code* on surveillance of disease of wildlife (as reported in its December 2020 report), which linked with the OIE Wildlife Health Framework and the OIE 7th Strategic Plan. The Commission was also provided with a brief analysis on the current recommendations on wildlife disease surveillance in the *Terrestrial Code*. 

The Code Commission acknowledged the request and discussed how this request could be considered in the context of the *Terrestrial Code*. The Commission noted that wildlife is currently covered in chapters describing, among others, surveillance system requirements (notably Chapter 1.4. Animal Health Surveillance), and therefore a new chapter dedicated to surveillance of wildlife health could result in duplication or inconsistencies. The Commission acknowledged that wildlife is dealt with as part of the epidemiology of listed or emerging diseases, with a focus on managing the impact on relevant domestic animal populations or humans, and recognised that some specificities of wildlife as such could be better taken into consideration in the current Chapter 1.4. and potentially in related horizontal and disease-specific chapters. The Commission also noted that, by definition and as described in Article 1.4.1., surveillance is paired with ‘action’ objectives, and that surveillance in wildlife should also have such objectives and be included in the logic of the *Terrestrial Code*. The Commission acknowledged that work on the User's guide may also be needed. The Commission concluded its discussion and advised the OIE Secretariat to take into consideration these points together with the health management expectations  for the better scoping of this proposed work.

The Code Commission highlighted the importance of this topic and reiterated its willingness to work with the Working Group on Wildlife in the scoping of a chapter for the *Terrestrial Code*. However, before its inclusion in the Commission’s work programme, it requested the Working Group on Wildlife to further discuss the purpose and work with the OIE Secretariat to assess any impacts on existing *Terrestrial Code*chapters. The Commission highlighted that this topic and proposal should also be discussed with the other Specialist Commissions and encouraged Members to comment on this work. 

5.4.	Prioritisation of items in the Code Commission’s work programme 

Based on a number of considerations and the progress of different topics made during this meeting (see items 5., 6. and 7. of this report) as well as in coordination with other Specialist Commissions (see item 4. of this report), the Code Commission updated its work programme and discussed the prioritisation of ongoing and future work. 

The updated work programme is presented as Annex 3 for Member comments.

**6.	Texts for comments and proposed for adoption in May 2022**

The Code Commission agreed to propose the following texts for adoption in May 2022, pending its consideration of comments received on these proposals.  

6.1.	Glossary definitions for ‘Competent Authority’, ‘Veterinary Authority’ and ‘Veterinary Services’

Comments received from Argentina, Australia, Canada, China (People’s Republic of), New Caledonia, New Zealand, Switzerland, the AU-IBAR and the EU.

Background

In September 2018, the Code Commission agreed to revise the Glossary definitions for ‘Competent Authority’, ‘Veterinary Authority’ and ‘Veterinary Services’ in the *Terrestrial Code*following Member requests and feedback from the *ad hoc* Group on Veterinary Services (2018 report). The revised definitions were circulated for comments in the Commission’s September 2018 report. The *ad hoc* Group on Veterinary Services considered comments received and proposed additional amendments. Given the importance of ensuring alignment of these definitions in the *Aquatic**Code* and *Terrestrial**Code*, where relevant, the Code Commission and the Aquatic Animals Commission agreed to work together on this matter. Revised definitions for ‘Competent Authority’, ‘Veterinary Authority’ and ‘Veterinary Services’ in the *Terrestrial Code* and ‘Competent Authority’, ‘Veterinary Authority’ and ‘Aquatic Animal Health Services’ in the *Aquatic Code* were circulated for comments in the September 2020 reports of the Code Commission and the Aquatic Animals Commission, respectively.

In preparation for the September 2021 meetings, the Presidents of the Code Commission and the Aquatic Animals Commission met to review all comments received and to consider if additional amendments were needed whilst also considering the importance of aligning these definitions, where relevant. They acknowledged that the comments received indicated some confusion amongst Members as to the intended meaning and use of these terms and that the September 2020 Commission reports did not provide sufficient information about the rationale for the proposed amendments. The Presidents agreed that the proposed definitions did not need significant changes and they proposed to provide a more detailed explanation of the rationale for the proposed amendments, as well as some more detailed information on the use of these terms in each *Code* in the two September 2021 Commission reports.

At the September 2021 meeting, each President informed its respective Commission about these discussions and sought input and agreement from Commission members. 

Discussion

The Code Commission considered the comments received on its September 2020 report as well as the feedback from the President regarding the coordination with the Aquatic Animals Commission. The Code Commission agreed that the proposed amended definitions did not need further substantial edits and the September 2021 meeting report should include a more detailed explanation on the purpose and current use of these definitions, as well as a clearer explanation of the proposed changes. 

The text presented below reflects the opinion of both Commissions and is presented in the September 2021 reports of the Aquatic Animals Commission and Code Commission to ensure a shared understanding in the context of both *Codes*.

***General consideration on Glossary definitions***

The objective of the Glossaries in the *Aquatic* and *Terrestrial**Codes* is to provide definitions of key terms that require precise interpretation for the purpose of their use in the *Codes*. These definitions might deviate from those provided by common dictionary definitions. It is desirable to pursue harmonisation where possible to assist interpretation by users of both *Codes* because Glossary terms should be used consistently throughout all chapters.

The Glossary definitions are expected to be concise and should not contain unnecessary descriptive detail or further elaborations beyond what is necessary to define the term. Further descriptive detail or explanation that may be necessary for the implementation of a standard are provided within the contents of the relevant chapters. 

***Purpose of the definitions of ‘Competent Authority’, ‘Veterinary Authority’ and ‘Veterinary Services’/‘Aquatic Animal Health Services’***

The purpose of these terms in the *Codes* is to differentiate responsibilities for implementation of the OIE standards. It is important to note that the definitions apply only for the purposes of each of the *Codes* and are not intended to dictate the administrative structure, or the naming of governmental authorities, within a Member Country. To achieve this purpose, the definitions must be applicable to the diversity of administrative arrangements among Members and must be sufficiently precise to provide clarity on the responsibilities for the implementation of the standards by relevant governmental authorities or public or private services.

***Current application of these definitions***

The *Terrestrial Code* uses the three terms extensively (‘Competent Authority’, ‘Veterinary Authority’ and ‘Veterinary Services’) across its different sections. The Code Commission considers that these terms are generally applied correctly in the *Terrestrial Code*, as explained above, and in line with the relevant horizontal recommendations in Section 3, Veterinary Services, notably Chapter 3.4. Veterinary legislation. However, the use of the terms will be reviewed once the revised definitions have been adopted.

The *Aquatic Code* currently uses the terms ‘Competent Authority’ and ‘Aquatic Animal Health Services’ but uses ‘Veterinary Authority’ only in certain Glossary definitions and in Section 5, Trade measures, importation/exportation procedures and health certification. This approach was previously adopted (i.e. ‘Competent Authority’ in place of ‘Veterinary Authority’) because governmental responsibilities for aquatic animal health and welfare are not necessarily the responsibility of a veterinary governmental authority/agency. The Aquatic Animals Commission is aware that there are currently some inconsistent and incorrect uses of the terms within the *Aquatic Code*. Proposals to address these issues will be made and proposed for comments once the revised definitions have been adopted. 

***Proposed changes to the definitions of ‘Competent Authority’, ‘Veterinary Authority’ and ‘Veterinary Services’ / ‘Aquatic Animal Health Services’***

A decision was made to revise these definitions because many users found they lacked clarity, which led to contradicting interpretations among Members, with significant discrepancies in the understanding of the terms. It is important to note that the changes proposed to the definitions are not intended to change their meaning or application, only to bring clarity. 

Some cross-references between the *Codes* within these definitions have been removed because they are irrelevant (e.g. references to the *Aquatic Code* within definitions in the *Terrestrial Code*). 

***a)	Competent Authority***

The proposed wording**recognises that, in many countries, more than one governmental authority is responsible for implementing standards of the*Terrestrial* or *Aquatic**Codes*. The term *Competent Authority* is intended to apply to any governmental authority with some responsibility for the implementation of some OIE standards. 

Key changes to the definitions include:

‒**‘responsibility... for implementation’**was deemed simpler, clearer language than the current reference to ‘competence for ensuring implementation’;

‒	‘in the whole or part of the territory’ reflects that under some administrative arrangements government authorities may have responsibility for certain standards over the whole territory of a country, or just over a part of it, e.g. provincial or state authorities;

‒	‘certain standards’ reflects that governmental authorities may have responsibility for a clearly defined area of standards. Responsibility for implementation of other standards of the *Codes* would be part of the mandate of different Competent Authorities within the same country.

These revisions are consistent with Article 3.4.5. on Competent Authorities of the *Terrestrial Code*. There is no equivalent chapter on Veterinary Legislation within the *Aquatic Code*.  

***b)	Veterinary Authority***

The level of detail in the existing definition was deemed unnecessary, and the definition was simplified to make it clearer. This term distinguishes the role of the *Veterinary Authority* as a single Competent Authority that has responsibility for communicating with the OIE and an overarching responsibility for implementation of OIE standards. Examples of the differentiated role for the Veterinary Authority include disease notification requirements or demonstrating compliance with international standards for international trade or for disease free status.****

The Aquatic Animals Commission agreed that it was necessary to include reference to coordinating the implementation of standards ‘by Competent Authorities’ in the Glossary definition of ‘Veterinary Authority’ for the purpose of the *Aquatic Code*. These words add clarity given that ‘Competent Authority’ is the primary term used within the *Aquatic*Code (refer to the section ‘current application of the definitions’ above) and also reflects the fact that the Veterinary Authority itself may not always be the Competent Authority with responsibility for the implementation of the standards of the *Aquatic Code*. The Code Commission did not consider this to be necessary in the definition for Veterinary Authority in the *Terrestrial Code*.

Key changes to the definitions include:

‒	‘comprising veterinarians, other professionals and paraprofessionals’ was removed as these words do not define the term and do not distinguish it from other governmental authorities;

‒	‘primary responsibility’ was included to distinguish the Veterinary Authority from other Competent Authorities;

‒	‘having the responsibility and competence for ensuring or supervising the implementation’ was changed to ‘having the primary responsibility ... for coordinating the implementation’**as this is more concise and direct language and reflects the fact that some standards may not be under the direct responsibility or competence of the Veterinary Authority;

‒	‘implementation of the standards of’ was included to replace ‘animal health and welfare measures, international veterinary certification and other standards of’**as the latter includes unnecessary detail*.*

***c)	Veterinary Services/Aquatic Animal Health Services***

This term covers a broad range of actors that are involved in the implementation of OIE standards and are not necessarily part of governmental authorities or regulatory agencies. This may be the case for standards that involve a complex chain of responsibilities to be appropriately implemented. The definition has been reduced substantially to the key defining elements.

This term does not refer to a defined governmental structure but to a combination of individuals and organisations, public and private, which cannot be individually listed in the definition. 

Key changes to the definitions include:

‒	The word ‘individuals’ was added to ensure that private veterinarians, aquatic animal health professionals, veterinary paraprofessionals and others, would be covered under the definition when appropriate. 

‒	The terms ‘Private sector organisations, aquatic animal health professionals, veterinarians, veterinary paraprofessionals or aquatic animal health professionals’**were removed as these were considered unnecessary, and could exclude other relevant actors.

‒	“that implement animal health and welfare measures and other standards and recommendations’ was changed to ‘that perform activities to implement standards*”*, to better differentiate from the more specific role of responsible government authorities, which are covered by the terms Competent Authority and Veterinary Authority. 

‒	‘implement standards of the*Aquatic Code/Terrestrial Code’*was included to replace ‘*animal*health and welfare measures and other standards and recommendations in the OIE*Terrestrial Code*and the OIE*Aquatic Code’,*as the latter includes unnecessary detail.**

‒	The current reference to the Veterinary Authority within the definition of Veterinary Services was not considered necessary, as the definition for Veterinary Authority is sufficiently clear, and was removed. 

‒	“Private sector organisations, veterinarians, veterinary paraprofessionals or aquatic animal health professionals are normally accredited or approved by the Veterinary Authority to deliver the delegated functions” was deleted to keep the definition simple and to the point, and as these elements are described in the relevant chapters of Section 3 of the *Codes*.

The revised Glossary definitions for ‘Competent Authority’, ‘Veterinary Authority’ and ‘Veterinary Services’ are presented in **Annex 4** for Member comments and are proposed for adoption at the 89th General Session in May 2022.

6.2.	Introduction to Recommendations on Veterinary Services (Article 3.1.1.) and Quality of Veterinary Services (Articles 3.2.3. and 3.2.9.)

Background

A new Chapter 3.1. Introduction to Recommendations on Veterinary Services and a revised Chapter 3.2. Quality of Veterinary Services were adopted at the 88th General Session in May 2021. 

At its February 2021 meeting, in response to comments, the Code Commission had agreed to consider the development of a definition for ‘One Health’ to ensure a shared understanding of the concept of ‘One Health’ in the context of the *Terrestrial Code*, and had requested the OIE Secretariat to consider the possibility of developing a definition of ‘One Health’ in collaboration with the Tripartite and other relevant partners. Similar comments were also raised during the 88th General Session in May 2021. 

Discussion

**Article 3.1.1.**

The Code Commission highlighted that ‘One Health’ is not exclusively the domain of the OIE, and therefore, any definition should be developed in collaboration with the Tripartite and other relevant partners. 

The Code Commission noted that the term ‘One Health’ is only used in Section 3 and not in a specific meaning for the purposes of the *Terrestrial Code*. Therefore, the Commission agreed that the development of a Glossary definition was not appropriate. Nonetheless, the Commission agreed to include some text that explained the meaning of the ‘One Health Approach’ on the first instance where the term was used. To this end, the Commission proposed to add ‘involving all relevant sectors and disciplines across the human-animal-environment interface’ at the end of the first paragraph, noting that this text was aligned with the definition used in the Tripartite Zoonoses Guide. 

**Articles 3.2.3.**

In considering the amendment in Article 3.1.1., the Code Commission reviewed other articles of the chapter where the term ‘One Health approach’ was used, and agreed to add ‘relevant’ before governmental authorities in the second paragraph of Article 3.2.3. 

**Article 3.2.9.**

In point 1(b), the Code Commission agreed with a comment to add a specific reference to the storage of veterinary medicinal products.

The revised Article 3.1.1. and Articles 3.2.3. and 3.2.9. are presented as **Annexes 5 and 6** for Member comments and are proposed for adoption at the 89th General Session in May 2022.

6.3.	Veterinary legislation (Articles 3.4.5. and 3.4.11.)

Background

A revised Chapter 3.4. Veterinary Legislation was adopted at the 88th General Session in May 2021. The chapter had undergone a thorough review and had been circulated five times for comments. 

At this meeting, the Code Commission considered comments received in the context of the 88th General Session, and also introduced changes as a consequence of the revision of the use of the term ‘sanitary measures’ across the *Terrestrial Code*. 

Discussion

**Article 3.4.5.**

In point 1(d), the Code Commission proposed to replace ‘sanitary measures’ with ‘measures and procedures’ it considered that the context did not match with the Glossary definition for ‘sanitary measures’. The Commission noted that as the text was recently adopted, comments on this article would only be considered if referred to this specific amendment.

**Article 3.4.11.**

In point 1(b), the Code Commission agreed to delete the terms ‘safe and effective’, noting that these terms which had been introduced in the version circulated in the Commission February 2021 report and adopted, did not make sense in the context of the paragraph. The Commission noted that safety and efficacy should be addressed in the regulation of all the steps mentioned (i.e. authorisation, importation, manufacture, wholesale, retail, usage of, commerce in, and disposal) and not be referred to independently. The Commission also noted that ‘safety and effectiveness’ are covered in the Glossary definition for ‘veterinary medicinal product’.

The revised Article 3.4.5. and 3.4.11. of Chapter 3.4. Veterinary legislation are presented as **Annex 7** for comments and is proposed for adoption at the 89th General Session in May 2022.

6.4.	Zoonoses transmissible from non-human primates (Chapter 6.12.)

Comments were received from Burkina Faso, Cameroon, Singapore, the USA, the AU-IBAR and the EU.

Background

In February 2019, in response to a request from the European Association of Zoos and Aquaria (EAZA), the Scientific Commission had requested the Working Group on Wildlife to conduct a review of the potential transmission of hepatitis B from gibbons to humans. In its March 2020 meeting report, the Working Group on Wildlife had concluded that hepatitis B was a disease of humans, as the *Hepadnaviridae* strains affecting humans are different from those affecting non-human primates. Moreover, current diagnostic techniques have made it possible to differentiate the different hepatitis B virus strains circulating in humans and non-human primates.

At its February 2021 meeting, the Code Commission considered the Scientific Commission’s proposal to amend this chapter to reflect that hepatitis B is a disease of humans and agreed to revise Articles 6.12.4., 6.12.6. and 6.12.7. The revised articles were circulated for comments in the Code Commission’s February 2021 report.

Discussion

The Code Commission was informed that the corresponding Chapter 3.10.10. Zoonoses transmissible from non-human primates in the *Terrestrial Manual* had been revised to reflect that hepatitis B is a disease of humans, not a zoonotic disease, and adopted in May 2021.

The Code Commission reiterated that, as noted in its February 2021 report, the scope of these proposed amendments was only to address this issue and that the chapter was not open for wider comments. In line with this decision, the Commission agreed not to address other comments.

The Code Commission considered relevant comments and agreed that no additional amendments were needed.

**Article 6.12.7.**

In point 5, the Code Commission did not agree with a comment to reinstate ‘hepatitis B’ and reiterated that the Working Group on Wildlife (March 2020) had concluded that hepatitis B was a disease of humans, as the *Hepadnaviridae* strains affecting humans are different from those affecting non-human primates. It also reiterated that current diagnostic techniques have made it possible to differentiate the different hepatitis B virus strains circulating in humans and non-human primates. 

The revised Articles 6.12.4., 6.12.6. and 6.12.7. of Chapter 6.12. Zoonoses transmissible from non-human primates are presented as **Annex 8** for Member comments and are proposed for adoption at the 89th General Session in May 2022.

6.5.	Stray dog population control (Dog population management) (Chapter 7.7.)

Background

In September 2018, the Code Commission agreed to revise Chapter 7.7. Stray dog population control to ensure it was aligned with the OIE Global Strategy to end human death due to dog-mediated rabies by 2030. 

The *ad hoc* Group on the Revision of Chapter 7.7. Stray dog population control was reconvened for a third time in 2021 via video conference to address comments on the revised draft chapter circulated in the Code Commission’s September 2020 report.

Discussion

The Code Commission considered the *ad hoc* Group’s report, including the revised draft Chapter 7.7., and commended its members for its comprehensive work.

The Code Commission reminded Members that the *ad hoc* Group report detailed the rationale for proposed amendments and responses to comments. The Commission encouraged Members to refer to the *ad hoc* Group’s report when considering the proposed revised chapter presented in Annex 9. The June 2021 *ad hoc* Group report on the Revision of Chapter 7.7. Stray dog population control is available on the OIE Website (https://www.oie.int/en/what-we-do/standards/standards-setting-process/ad-hoc-groups/). 

In addition, the Code Commission made the following additional amendments.

Definitions

The Code Commission noted the *ad hoc* Group’s proposal to replace the current definition of ‘stray dog’ with ‘free-roaming dog’ in the Glossary. The Commission agreed with the Group’s proposed definition which considers all categories of dogs under the scope of the revised chapter. 

**Article 7.7.1.**

The Code Commission agreed to add a reference to Chapter 7.1. in the last sentence of this article as it deemed important to consider the concepts described in that chapter when developing dog population management (DPM). 

**Article 7.7.2.**

The Code Commission decided to move the definitions section from Article 7.7.4., to Article 7.7.2., to align with the format used in other chapters of the *Terrestrial Code*.

**Article 7.7.5.**

In the fifth indent, the Code Commission moved ‘traffic accident’ in front of ‘zoonotic diseases’ to improve readability and consistency.

**Article 7.7.7.**

In the second sentence of point 1, the Code Commission deleted the word ‘level’, when referring to the action plan, as it considered it unnecessary as such plans should be developed at the highest level possible.

**Article 7.7.8.**

In the subtitle, the Code Commission decided to include the term ‘actors’ to cover other participants that may have a role in the development of DPM programmes.

**Article 7.7.9.**

In the sixth indent, the Code Commission decided to modify the text to clarify that licencing is for ‘veterinarians’ and not for the practice of veterinary medicine.

**Article 7.7.11.**

In the first paragraph, the Code Commission agreed to modify the first sentence to indicate that there is a need for assessment and planning at the initial stage of the development of a DPM programme.

**Article 7.7.12.**

In the first paragraph, the Code Commission agreed to modify the first sentence to indicate that there is a need for monitoring and evaluation at the later stages of the development of a DPM programme.

**Article 7.7.15.**

In the last sentence of the last paragraph, the Code Commission replaced the wording proposed by the *ad hoc* Group from ‘sales from the street’ to ‘unregulated sales’ to improve clarity.

**Article 7.7.20.**

In the third paragraph, the Code Commission added a reference to Chapter 7.1. Introduction to the recommendations for animal welfare to highlight the need to ensure that the welfare of dogs is taken into consideration when they are transported.

In the last sentence of the last paragraph, the Code Commission did not agree with the *ad hoc* Group’s proposal, in response to a comment, to replace the term ‘should’ with ‘must’, noting that the use of the term ‘should’ is in line with the language used in the *Terrestrial Code*.

**Article 7.7.21.**

In the first sentence of the first paragraph, the Code Commission deleted the term ‘Veterinary Services’ as provider of veterinary care, noting that other actors may provide this care.

**Article 7.7.23.**

In the first sentence, the Code Commission replaced the word ‘prevalence’ with ‘occurrence’, because prevalence is a defined term in the Glossary used in relation to diseases.

**Article 7.7.26.**

In the first paragraph, the Code Commission discussed the recommendation of the *ad hoc* Group to include a reference to the term ‘five-welfare needs’, in particular the ones related to the conditions that dogs may be subjected to in premises keeping dogs. The Commission agreed to delete this reference given that there is no reference to these needs in the *Terrestrial Code*, noting that the text includes a description of these needs.

The revised Glossary definition of ‘Stray dogs’ is presented in Annex 4 for Member comments.

The revised Chapter 7.7. Stray Dog population control is presented as Annex 9 for Member comments and is proposed for adoption at the 89th General Session in May 2022.

6.6.	Infection with rinderpest virus (Chapter 8.16.)

Comments were received from Cameroon, Burkina Faso, New Zealand, Thailand, the AU-IBAR and the EU.

Background

A thorough review of Chapter 8.16. Infection with rinderpest virus was undertaken by the *ad hoc*Group on Rinderpest (March 2020 report), in response to Member requests and to better clarify the definitions of ‘case’ and ‘suspected case’, the reporting obligations of Members, and the inclusion of measures that should be implemented if there is a re-emergence of rinderpest virus.

The Code Commission had agreed with the Scientific Commission and OIE Secretariat that in this post-eradication era, the priority should be the maintenance of global freedom from rinderpest and its prompt recovery in case of re-emergence, and consequently, the structure of the chapter and trade provisions should be revised to ensure they are aligned with this objective. The revised chapter was circulated for comments for the second time in the Commission’s February 2021 report.

Discussion

**Article 8.16.1.**

In the first paragraph of point 1, the Code Commission further considered a comment discussed at its previous meeting regarding a request to add a footnote referring to the OIE resolution that noted that the manipulation of existing RPV-containing material is forbidden unless authorised by the FAO and OIE. The OIE Secretariat informed the Code Commission that OIE resolutions are not referenced in the *Terrestrial Code.*The Commission agreed that given that OIE resolutions have been adopted by the World Assembly, there was no need to provide a cross-reference to the original resolution. The Commission agreed that given this article includes text that addresses key aspects of what was stated in the resolution, a specific reference to the resolution should not be included. The Commission also amended some text in this paragraph to improve clarity. 

In point 2(b), the Code Commission did not agree with a comment to add ‘and the finding has been confirmed at an OIE reference laboratory’ after ‘identified’ in point (i), and after ‘animal’ in point (ii), and explained that this point is to define what a case is. The way a case should be confirmed is described in Article 8.16.3.

In point 2(b)(iii), the Code Commission did not agree with a comment to delete ‘that are not a consequence of *vaccination*’ after ‘antibodies’. The Commission noted that vaccination had been globally banned since 2008, and therefore, some previously vaccinated animals could be still alive. It also reminded Members of the rationale presented in its February 2021 report that this information may be relevant in the event of re-emergence of rinderpest if emergency vaccination is used.

In response to comments to better differentiate the definition of a ‘suspected case’ from a ‘potential case’, the Code Commission noted that the identification of potential cases was based on the exclusion of other possible causes of ‘stomatitis-enteritis syndrome’ by epidemiological or clinical investigations only, while if other diseases had been ruled out by laboratory investigations, it should be considered a ‘suspected case’. The Commission agreed to amend the text to improve clarity in point 2(c)(i), to replace ‘or’ by ‘and’ before ‘laboratory investigation’; and, in point 3(b), to add ‘clinical or’ before ‘epidemiological considerations’, and delete ‘appropriate laboratory’ before investigation. 

**Article 8.16.2.**

In point 2(a), the Code Commission agreed to delete ‘which have been submitted to the usual chemical and mechanical processes in use in the tanning industry’ at the end of the point, for consistency with the general approach used for ‘safe commodities’ in the *Terrestrial**Code*, noting that Chapter 2.2. Criteria applied by the OIE for assessing the safety of commodities states that for commodities that meet the criteria “it is expected that processing or treatment (i) uses standardised protocols”. 

**Article 8.16.3.**

In the first sentence of the first paragraph, the Code Commission agreed to delete ‘infection’ after ‘rinderpest’ and to replace ‘rinderpest absence’ with ‘absence of infection with RPV’ for consistency with other text of the chapter. 

In the third sentence of the first paragraph, the Code Commission did not agree with a comment to delete ‘potential’ before ‘cases’ as it considered it was needed for clarity. 

**Article 8.16.4.**

In the first sentence, the Code Commission did not agree with a comment to amend the text to avoid redundancy, as it considered that ‘annual report’ referred to the scope of the report, while ‘submitted every year’ referred to the frequency of submission, which would not necessarily be the same.

**Article 8.16.5.**

In the first sentence, the Code Commission agreed to replace ‘notified’ by ‘reported’ for consistency with the Glossary definitions and use of this term in other parts of the *Terrestrial Code* where ‘reporting’ refers to communication to the Veterinary Authority at country level and ‘notification’ refers to the action performed by Veterinary Authorities to the OIE. 

In the first two paragraphs, the Code Commission discussed the feedback from the OIE Secretariat on its query, from February 2021, regarding the legal obligation for the notification of suspected cases of rinderpest. The Commission agreed that, based on the notification obligations stated in Chapter 1.2. and in the OIE Basic Texts, the text as written provided sufficient grounds to establish a disease-specific requirement for mandatory notification of suspected cases for this disease. The Commission requested that the OIE Secretariat consider mechanisms to ensure this is feasible through OIE-WAHIS.

In the fourth paragraph of point 2, the Code Commission did not agree with a comment to replace ‘may’ by ‘should’ for consistency with the changes proposed in Article 8.16.8. The Commission noted that the selection of the disease control measures is the prerogative of Members and clarified that the use of ‘should’ in the context of Article 8.16.8. refers to the compliance with OIE standards in the case that a country chooses to establish a containment zone.

**Article 8.16.6.**

In the first paragraph, in response to a comment proposing a timeframe for the submission of the risk assessment to the OIE, the Code Commission agreed with the Scientific Commission on the importance of having a short time limit for risk assessment showing that all potential pathways for introduction are adequately managed and that all OIE Members should be asked to provide such assessment to be evaluated and approved by the OIE. Nevertheless, it considered that no amendment was needed in the text and this timeframe would be decided by the OIE if and when rinderpest reemerges. 

In the same paragraph, the Code Commission did not agree with a comment requesting to amend the text to clarify how and when the free status of a country would be reinstated if suspended, as it considered the text sufficiently clear for the purposes of the *Terrestrial Code*. 

The Code Commission agreed that the details for processes such as those discussed in the paragraphs above were outside the scope of the *Terrestrial Code* and should not be included in the chapter. The Commission requested the OIE Secretariat to consider the development of the appropriate processes and guidance as part of the OIE Official Status recognition system. 

**Article 8.16.9.**

In the first paragraph, the Code Commission did not agree with a comment to replace ‘free from rinderpest’ by ‘free from infection with RPV’. The Commission explained that the text is the current convention for the *Terrestrial Code*, and ‘rinderpest’ is defined in the first article of the chapter. 

In the second paragraph, the Code Commission did not agree with a comment to reinstate ‘rinderpest’ before ‘free status’, as it considered this unnecessary and referred Members to the rationale provided in its February 2021 report in support of this deletion. 

**Article 8.16.11.**

In point 2, the Code Commission noted a comment regarding the use of the term ‘potential case’, and agreed that due to the changes introduced on Article. 8.16.1., no further amendments were needed. 

**Article 8.16.12.**

In the title of the article, the Code Commission agreed with a comment to delete ‘rinderpest’ before ‘susceptible animals’, as these were already defined in Article 8.16.1.

**Article 8.16.13.**

The Code Commission did not agree with a comment to replace ‘not free from’ by ‘infected with’, and reiterated the rationale presented in its February 2021 report, that countries whose free status have been suspended in accordance with the first paragraph of Article 8.16.6. are covered by this article. 

The revised Chapter 8.16. Infection with rinderpest virus is presented as **Annex 10** for Member comments and is proposed for adoption at the 89th General Session in May 2022.

6.7.	Infection with *Echinococcus granulosus* (Chapter 8.5.) and Infection with *Taenia solium* (Porcine cysticercosis) (Chapter 15.4.) 

Background

In February 2020, the Code Commission considered a request from the World Health Organization (WHO) to update the *Terrestrial Code* Chapters on Infection with *Echinococcus granulosus* (Chapter 8.5.) and Infection with *Taenia solium* (Porcine cysticercosis) (Chapter 15.4.), as well as the corresponding chapters in the *Terrestrial Manual* because of developments in the area of vaccine production and vaccination. 

At its September 2020 meeting, the Code Commission noted that work had commenced to update the corresponding chapters of the *Terrestrial Manual*, and requested the OIE Secretariat to prepare amended versions of Chapters 8.5. and 15.4. of the *Terrestrial Code*, taking into consideration the changes included in the *Terrestrial Manual*, and in consultation with relevant experts.

A revised Chapter 3.10.3. on ‘Cysticercosis (including infection with *Taenia solium*)’ of the *Terrestrial Manual* was adopted in May 2021, and a revised Chapter 3.1.6. on ‘Echinococcosis’ (infection with *Echinococcus granulosus* and with *E. multilocularis*) has been developed and is intended to be presented for adoption in 2022. 

Update

The Code Commission reviewed proposed amendments to Chapter 8.5. Infection with *Echinococcus granulosus* and Chapter 15.4. Infection with *Taenia solium* (Porcine cysticercosis) to reflect the latest modifications included or proposed in the *Terrestrial Manual*., prepared through an electronic consultation with some members of the *ad hoc* Group on Porcine Cysticercosis who had developed the revised draft chapter in 2015. 

The Code Commission also reviewed each chapter and agreed that the text was still relevant and did not need updating except to address the use of vaccination. The Commission agreed to introduce specific provisions to include vaccines as prevention or control tools and to ensure any amendments were aligned with changes in the *Terrestrial Manual* chapters.

Regarding Chapter 15.4., the Code Commission noted that the sections on meat inspection had been removed from the *Terrestrial Manual* as they were not considered relevant for the *Terrestrial Manual*. The Commission considered the text removed from the *Terrestrial Manual* and agreed that no further amendment was needed in Chapter 15.4. of the *Terrestrial Code*.

The revised Chapter 8.5. Infection with *Echinococcus granulosus* and Chapter 15.4. Infection with *Taenia solium* (Porcine cysticercosis) are presented as **Annex 11** and **Annex 12,**respectively, for Member comments and are proposed for adoption at the 89th General Session in May 2022.

6.8.	Bovine spongiform encephalopathy (Chapter 11.4.), Application for official recognition by the OIE of risk status for bovine spongiform encephalopathy (Chapter 1.8.) and Glossary definition for ‘protein meal’

Background

In February 2018, following preliminary work and scientific exchanges, the Code Commission and the Scientific Commission agreed to an in-depth review of Chapter 11.4. Bovine spongiform encephalopathy (BSE). The OIE convened three different *ad hoc* Groups between July 2018 and March 2019: i) an *ad hoc* Group on BSE risk assessment, which met twice, ii) an *ad hoc* Group on BSE surveillance, which met once, and iii) a joint *ad hoc* Group on BSE risk assessment and surveillance, which met once. The Code Commission, at its September 2019 meeting, reviewed the four *ad hoc* Group reports and the opinion of the Scientific Commission regarding the draft revised chapter and circulated a revised draft Chapter 11.4. for comments.

In February 2020, the Code Commission considered comments received on the revised draft Chapter 11.4. and requested that the joint *ad**hoc* Group on BSE risk assessment and surveillance be reconvened to address comments of a technical nature. In June 2020, the joint *ad hoc*Group was convened to address relevant comments and was also requested to review Chapter 1.8. Application for official recognition by the OIE of risk status for bovine spongiform encephalopathy to ensure alignment with the proposed changes in Chapter 11.4.

In September 2020, the Code Commission reviewed the joint *ad hoc* Group report and the revised draft Chapters 11.4. and 1.8. and made some additional amendments and circulated the revised chapters for comments in its September 2020 report. In February 2021, the Commission considered comments received and amended the chapters, as appropriate, and circulated the revised chapters for a third round of comments.

In preparation for the September 2021 meetings, some members of the Code Commission and the Scientific Commission met to discuss key aspects of the revision of Chapters 11.4. and 1.8. to ensure a common understanding of the main concerns raised by Members, the decisions made on the revised chapters and their impact on the official status recognition, as well as on the adapted procedures that will be required. During this meeting, it was agreed that each Commission would address the issues relevant to its meeting and document discussions in their respective reports.

Discussion

a)	**Chapter 11.4. Bovine spongiform encephalopathy**

Comments were received from Argentina, Australia, Brazil, Burkina Faso, Cameroon, Canada, China (People’s Rep. of), Japan, New Zealand, the USA, Members of the OIE Asia, Far East and Oceania Region, the AU-IBAR, the CVP, the EU, and the WRO. 

**General comments**

The Code Commission noted concerns raised by some Members that the proposed concept that two subpopulations (the cattle population born before the date from which the risk of BSE agents being recycled has been negligible and the cattle population born after that date) would be differentiated within a country or zone recognised as either negligible or controlled BSE risk, and the proposal that the recommendations for importation from ‘negligible BSE risk’ and ‘controlled BSE risk’ be merged would increase the administrative burden to the OIE and its Members for official status recognition and create more onerous steps for certification. The Commission .  highlighted that currently used export certificates contain often stricter provisions than those recommended in the *Terrestrial Code*, and often included the age or birthdate of live cattle, and sometimes a maximum age of cattle from which meat is derived, without clear risk mitigation justification; in this regard, the respect by importing countries of the proposed certificates would be a great improvement in terms of trade facilitation. The Commission also noted that for Members having negligible BSE risk status, the cattle population born before the date from which the risk of BSE agents being recycled has been negligible has become extremely small and the impact on trade would not be as significant than presented by the Members. Moreover, the Commission, based on previous considerations and on the *ad hoc* group reports, reminded Members that official status recognition for BSE has always been considered a risk status and not a freedom status, and therefore the concept that different cattle populations and commodities derived from these animals present different risks is not new, rather it is inherent in the OIE’s approach to BSE risk management already applied to official status recognition. 

In response to concerns that the revised BSE provisions may impact Members who currently have a recognised BSE risk status, the Code Commission reminded Members that the potential impact had been  discussed in previous *ad hoc* Group and Scientific Commission reports. In addition, the Code Commission explained that it would be discussed further at the September 2021 meeting of the Scientific Commission. The Code Commission encouraged Members to refer to the September 2021 report of the Scientific Commission for outcomes of its discussion.

The Code Commission considered the text ‘period when the risk of BSE agents being recycled within the cattle population has been demonstrated to be negligible’ and agreed that  the use of the term ‘period’ was not clear. The Commission agreed that ‘date’ (of effective implementation of BSE risk mitigation measures) would be a more appropriate term considering that a period should have a start and end date, the latter being not the case. Accordingly, the Commission proposed to change ‘period’ to ‘date’ throughout Chapter 11.4. as well as in Chapter 1.8., as appropriate. The Code Commission also noted that the Scientific Commission would consider at its September 2021 meeting how to define the date for each Member which has an official BSE risk status and how to communicate this to all Members, and encouraged Members to refer to the report of the meeting.

In response to a comment that the level of surveillance considered appropriate to maintain a negligible risk status is unclear, the Code Commission reminded Members that the rationale for removing the point-based BSE surveillance has been provided in previous *ad hoc* Group, Code Commission and Scientific Commission reports. The Code Commission encouraged Members to refer to the June 2020 report of the *ad hoc* Group on BSE risk assessment and surveillance for relevant information.

The Code Commission agreed with a comment to change ‘foetal’ to ‘fetal’ as this reflected current usage in scientific literature. The Commission noted that this term as well as ‘foetus’ are used in other chapters of the *Terrestrial Code* and should also be amended accordingly. The Commission requested that the OIE Secretariat review the use of these terms in the *Terrestrial Code* in order to determine where they need to be amended and to report back to the Commission at its next meeting.

**Article 11.4.1.**

In point 1, the Code Commission agreed with a comment to move the fourth sentence ‘Oral exposure to contaminated *feed* is the main route of transmission of classical BSE.’ to after the second sentence as it considered the proposed order (description on classical BSE and then description on atypical BSE) improved clarity.

In the same point, the Code Commission did not agree with a comment to amend the last sentence to reflect that the risk of atypical BSE agent being recycled in a cattle population is negligible and reminded Members that the joint *ad hoc* Group on BSE risk assessment and surveillance had concluded that atypical BSE is considered capable of being recycled in a cattle population if cattle are exposed to contaminated feed. The Commission encouraged Members to refer to the relevant information provided in the March 2019 report of the *ad hoc* Group on BSE risk assessment and surveillance.

In point 3(b), the Code Commission agreed with a comment to replace ‘PrPBSE’ with ‘PrPSc’ in order to align with the corresponding Chapter 3.4.5. in the *Terrestrial Manual*.

In point 4(b), the Code Commission agreed with a comment to delete ‘blood and blood products’ from the exclusion from the definition for ‘protein meal’, as it considered that blood is a tissue and is included in the definition of meat. The Commission explained that blood and blood products that went through the rendering process are included in the proposed definition for ‘protein meal’ and hence are considered in the entry and exposure assessments described in Article 11.4.2.

**Article 11.4.1bis.**

In point 7, the Code Commission did not agree with a comment to delete ‘foetal blood’ and reiterated its decision to add ‘foetal blood’ to the list of safe commodities was based on the rationale provided by BSE experts, i.e. i) blood *per se* is considered free of BSE infectivity; ii) even if prions were present in blood due to slaughter practices the placental barrier of bovines would make BSE maternal transmission unlikely; and iii) it is unlikely that cross contamination with potentially infected tissues from a cow occurs during foetal blood collection. The Commission encouraged Members to refer to the June 2020 report of the joint *ad hoc* Group on BSE risk assessment and surveillance where the rationale is reported in more detail.

**Article 11.4.2.**

In the first paragraph, the Code Commission noted comments that ‘Due to its etiological and epidemiological features’ was unnecessary as these features are common to the determination of risk for any disease, and considered that official recognition for BSE considers a risk status and not a freedom status as is the case for other diseases for which the OIE grants official recognition of status, and because of this specificity, this phrase should be kept. However, the Commission proposed to add ‘specific’ before ‘etiological’ for clarity.

In point 1(a)(iii), in response to a comment to delete ‘(not intended for pets)’, the Code Commission proposed to replace it with ‘(except packaged and labelled pet food)’ as it considered that although appropriately packaged and labelled pet food does not need to be taken into consideration, pet food in bulk or raw materials for pet food should be considered in the entry assessment, and the risk of feeding to cattle should be assessed in the subsequent exposure assessment. The Commission proposed a similar amendment in Article 1.8.5.

In point 1(b)(i), under the first indent, the Code Commission agreed with a comment to add ‘and farming’ after ‘production’ to ensure alignment with point 2(a)(i) of the revised Article 1.8.5.

In point 1(d), the Code Commission agreed with comments to delete ‘through the feeding of ruminant-derived protein meal, with indigenous cases arising’, and explained that given the feeding of ruminant-derived protein meal is the principal transmission pathway of BSE agents, the exposure assessment described in the point 1(b) focuses on this pathway; however, the risk estimation described in point 1(d) is a standalone result that combines the conclusions from points 1(a), 1(b) and 1(c). Additionally, the Commission reiterated that the risk for each Member would be assessed, as appropriate, by the *ad hoc* Group on the Evaluation of BSE risk status of Members. This amendment was also made in point 4 of Article 1.8.5.

In the same point, in response to a proposal noted in the June 2021 *ad hoc* Group report on the revision of BSE standards and its impact on the official status recognition and a comment received previously, the Code Commission agreed to add ‘and to determine the date from which the risk of BSE agents being recycled within the cattle population has been negligible’ at the end of the point. The Commission confirmed that this would be the result of the risk estimation, and noted that the addition will ensure alignment with point 4(d) of the revised draft Article 1.8.5.

**Article 11.4.3.**

In the first paragraph, the Code Commission did not agree with a comment to reinstate ‘compartment’ and reminded Members that the OIE grants official status for countries and zones only, and not for compartments. The Commission noted that it had proposed a new Article 11.4.4bis. for a compartment with negligible or controlled BSE risk. The Commission noted that this response also applied to a similar comment submitted for Article 11.4.4.

In the same paragraph, the Code Commission agreed with a comment to reinstate ‘at least’ as it considered the deletion had caused confusion. The Commission reiterated that a Member applying for official recognition of a negligible BSE risk status for a country or zone, may be able to demonstrate that the risk of BSE agents being recycled in the cattle population has been negligible for eight years or more and, in that case, the Member should demonstrate compliance with all four steps of the risk assessment as described in this article for the years that it wished to consider.

In point 1, the Code Commission did not agree with a comment to reinstate the deleted point 1(a) ‘Protein meal derived from ruminants has not been fed to ruminants’, as it was not needed here, since it was covered by the preceding article. It explained that as described in point 1 of Article 11.4.1., oral exposure to contaminated feed is the main route of transmission of classical BSE and therefore the exposure assessment described in point 1(b) of Article 11.4.2. considers the impact of both ‘livestock industry practices preventing cattle from being fed ruminant-derived protein meal’ and ‘specific risk mitigation measures preventing cattle from being fed ruminant-derived protein meal’. The Commission noted that Members need to demonstrate that any assessed risks have been properly mitigated in order to obtain official BSE risk status, and that would imply the prevention of feeding ruminants with ruminant-derived protein meal. The Commission reminded Members that the dossier for each Member would be assessed by the *ad hoc* Group on the Evaluation of BSE risk status of Members. The Commission noted that this response also applies to a similar comment submitted for Article 1.8.5. 

In points 3(b)(i) and 3(i)(ii), the Code Commission considered a comment seeking clarification of these requirements and proposed amended text to align with its new proposal to refer a ‘date’ rather than a ‘period’ (see General comments section above).

In point 3(b)(ii), the Code Commission agreed with a request for stricter requirements in the case of the occurrence of indigenous case of classical BSE in an animal younger than eight years, and added ‘any identified source of *infection* has been mitigated and’ after ‘confirmed that’. The Commission considered that the occurrence of an indigenous case of classical BSE born after the date from which the risk of BSE agents being recycled within the cattle population has been negligible does not necessarily reflect a breakdown of effective control measures but rather may be due to isolated pockets of residual infectivity in a complex network of rendering, feed production, distribution and storage (refer to the June 2020 report of the *ad hoc* Group on BSE risk assessment and surveillance for a more detailed rationale). The Commission emphasised that it is essential that the source be properly investigated and any identified issues be rectified.

In point 4, in response to a comment to add provisions to manage the risk associated with cohort animals, the Code Commission reiterated that the complete destruction of all cohort animals would not provide a significant gain in risk reduction, as long as measures including a feed ban and the removal and destruction of tissues listed in Article 11.4.14. had been continuously and effectively implemented, and an effective surveillance system for the detection and investigation of cases was in place. The Commission reminded Members to refer to the July 2018 report of the *ad hoc* Group on BSE risk assessment for more details.

In the same point, the Code Commission did not agree with a comment to add ‘to ensure that the distal ileum, skull, brain, eyes, vertebral column and spinal cord of the case does not enter the animal feed chain’ as it considered that the text was clear as presented and that specifying the risk materials was not needed given that any case of BSE should be disposed of in a biosecure manner. 

**Article 11.4.3bis.**

In the first paragraph, the Code Commission agreed with a comment to add ‘any identified source of *infection* has been mitigated and’ based on the rationale provided above (see point 3(b)(ii) of Article 11.4.3.).

**Article 11.4.4.**

In the first paragraph, the Code Commission did not agree with a comment to replace ‘at least one of these conditions has not been met for the preceding eight years’ with ‘the mandatory eight-year time frame has not yet been met’, as it considered the text clear as written. The Commission explained that a controlled BSE risk status is a step towards the negligible BSE risk status, and that the BSE risk of a country or zone can be considered to be controlled provided all of the conditions described in points 1 to 4 of Article 11.4.3. have been met, but at least one of these conditions has not been met for the preceding eight years. Once all the conditions have been met for eight years or more, the BSE risk of a country or zone can be considered negligible.

**Article 11.4.5.**

In the text of the article, the Code Commission agreed with a comment to delete ‘compartment’, as it considered that by definition, a compartment is a subpopulation with a specific animal health status.

**Deleted Article 11.4.6.**

The Code Commission did not agree with comments to reinstate the deleted Article 11.4.6. The Commission reiterated that two subpopulations (cattle population born before the date from which the risk of BSE agents being recycled has been negligible and cattle population born after that date) are differentiated within a country or zone recognised as negligible  or controlled BSE risk and therefore to merge Article 11.4.6. with Article 11.4.7. is appropriate.

**Article 11.4.7.**

In point 2, the Code Commission agreed with comments to replace ‘the country’ with ‘a country’ noting that the intention of this provision was not that the exported cattle must be born in the exporting country. 

In the same point, the Code Commission proposed to add ‘and kept’ after ‘born’ in response to a comment that pointed out a possibility that the cattle was kept and exposed to protein meal in a country that was different than a country where the cattle was born. The Commission noted that this rationale also applies to similar comments received for Articles 11.4.10., 11.4.12. and 11.4.13.

**Article 11.4.8.**

In the title of the article, the Code Commission proposed to delete ‘compartment’ based on the rationale provided above (see Article 11.4.5).

**Deleted Article 11.4.9.**

The Code Commission did not agree with comments to reinstate the deleted Article 11.4.9. based on the rationale provided above (see General comments).

**Article 11.4.10.**

In point 1, the Code Commission did not agree with a comment to move ‘the cattle from which the *fresh meat* and *meat**products* were derived’ to the end of the chapeau paragraph, because the subject of point 4 is ‘the fresh meat and meat products’ not the cattle.

In point 1, the Code Commission proposed to delete ‘came from a country, *zone* or *compartment* posing a negligible or controlled BSE risk and’ as it considered this text to be redundant.

**Article 11.4.12.**

In point 2, the Code Commission did not agree with comments to delete the whole or latter part of this point as it considered the point relevant and feasible. The Commission explained that for most Members who already have a negligible BSE risk status, the cattle population born before the date from which the risk of BSE agents being recycled has been negligible has become extremely small. The Commission encouraged Members to refer to the Commission’s February 2021 report for more details.

The Code Commission did not agree with a comment to amend points 1 and 2 and add a new third point to demonstrate animals have not been fed protein meal derived from ruminants, as it considered the recommendation sufficient as written and explained that the third proposed requirement would not provide any added value as the recommendation for importation of protein meal,  which is different from the recommendation for importation of cattle described in Article 11.4.7.

In response to a comment to align this article with other similar articles, the Code Commission proposed to delete point 1 and to rephrase point 2. It also reiterated that in accordance with this chapter, only Members with negligible BSE risk can export cattle-derived protein meal.

**Article 11.4.13.**

In the title, the Code Commission did not agree with a comment to delete ‘(except foetal blood)’ based on the same rationale provided above (see Article 11.4.1bis.).

In point 1 and point 2, the Code Commission did not agree with comments to revert to original texts based on a similar rationale provided above (see General comments).

The Code Commission did not agree with a comment to delete points 1 and 2, as it considered the points are relevant and ensure the safe trade of blood and blood products. It encouraged Members to refer to the March 2019 report of the *ad hoc* Group on BSE risk assessment and surveillance for more details on the development of this article.

The Code Commission proposed to merge points 1 and 2 to ensure alignment with the proposal for Article 11.4.12.

**Article 11.4.14.**

In point 1, the Code Commission did not agree with a comment to add ‘and tonsils’ after ‘Distal ileum’ and reminded Members that the March 2019 report of the *ad hoc* Group on BSE risk assessment and surveillance had concluded that the reference to tonsils should be removed. 

In the same point, the Code Commission did not agree with a comment to add ‘or death’ after ‘slaughter’ as it considered this was implied, and that only those tissues from slaughtered animals should be traded.

In point 1(b), the Code Commission did not agree with comments to delete ‘or a negligible BSE risk’ based on the rationale provided above (see General comments).

In point 2, in response to a comment that the commodities are already noted in point 1 and thus are redundant, the Code Commission explained that point 1 and point 2 refer to different products; point 1 is for ingredients of final products such as feed and fertilisers and point 2 is for the final products.

**Article 11.4.16bis.**

In point 3, in response to a comment to clarify the parameters for temperature, time and pressure to safely produce tallow derivatives, the Code Commission informed Members that the *ad hoc* Group on the Revision of BSE standards and its impact on the official status recognition, had considered this comment at its meeting in June 2021. The Commission noted that the *ad hoc* Group had stated that they could not specify any particular parameters because there is a wide variation in the conditions under which these products are commercially produced, based on evidence available in the literature. The *ad hoc* Group agreed to maintain the text as it is, given the absence of no new scientific evidence. The Commission agreed with the position of the *ad hoc* Group.

In the same point, the Code Commission did not agree with a comment to replace the text with ‘have been submitted in a system (as filtration, centrifugation or decantation or others) that guarantees maximum level of tallow’s insoluble impurities of 0.15%’ as it considered that although the proposed procedure is scientifically valid in terms of mitigating the BSE risk, Members do not need to specifically certify it as a BSE risk mitigation measure, since the final products are safe commodities as described in point 5 of Article 11.4.1bis.

The Code Commission agreed with a proposal to move Article 11.4.16bis. before Article 11.4.16., as Article 11.4.15bis. to improve the flow of these articles.

**Article 11.4.17.**

The Code Commission did not agree with a comment to delete this article and emphasised that this article is not intended to be used as an import requirement but rather a recommendation to mitigate the BSE risk of protein meal. In addition this article is referred to in the revised draft Article 1.8.5.

In the chapeau paragraph, the Code Commission did not agree with a comment to replace ‘should’ with ‘may’. It considered that this article describes a recommendation to mitigate the BSE risk, i.e. to reduce BSE infectivity, and the procedure scientifically sound, and thus the recommendation should be described as what ‘should’ be done to mitigate the BSE risk.

In the same paragraph, the Code Commission did not agree with a comment proposing to limit the scope of the article to countries that have reported classical BSE cases in indigenous cattle as it considered that the recommendation is potentially relevant for all countries. 

In response to a comment to replace ‘ruminant proteins’ with ‘any of those commodities listed in point 1 of Article 11.4.14.’, the Commission reiterated that this recommendation should include not only commodities with the greatest BSE infectivity which are described in point 1 of Article 11.4.14. but also protein meal containing ruminant proteins that may contain BSE agents.

**Article 11.4.18.**

In the title, the Code Commission agreed with a comment requesting alignment with Article 1.8.6. and proposed to delete ‘BSE’ from the title of Article 1.8.6.

The Code Commission reminded Members that the Commission, based on the proposal from the *ad hoc* Group on BSE surveillance, had proposed extensive amendments to the article on BSE surveillance, including the removal of provisions on point-based BSE surveillance, as a consequence of redefining the goals of BSE surveillance. The Commission encouraged Members to refer to the October 2018 report of the *ad hoc* Group on BSE surveillance for more details.

The Code Commission agreed with a comment stating that an early warning system and an awareness programme should be sufficient to support a negligible BSE risk status and therefore a targeted active surveillance should not be required. The Commission reiterated that the surveillance proposed for BSE focuses on passive surveillance which is a mechanism to demonstrate that the risk of classical BSE is still low. It highlighted that any good early warning systems do include clinical screening and target subpopulations that are more likely to be positive.

In the first paragraph, in response to a comment to describe the goals of the revised surveillance system, the Code Commission explained that this article describes how surveillance for BSE should be designed and implemented, and does not describe the system for surveillance. The Commission reiterated that the goal of the proposed provisions for surveillance is to detect a potential emergence or re-emergence of classical BSE within the cattle population, and not to assess the effectiveness of mitigation measures such as a feed ban. The Commission encouraged Members to refer to the October 2018 report of the *ad hoc* Group on BSE surveillance and the June 2020 report of the *ad hoc* Group on BSE risk assessment and surveillance for more details.

In point 1(b), the Code Commission agreed with a comment to remove the parentheses around ‘(head shyness)’ as it agreed that low carriage of the head and head shyness are not the same.

In the third paragraph, the Code Commission did not agree with a comment to replace ‘spectrum’ with ‘continuum’ as it considered the text clear as written. 

The Code Commission did not agree with the request to move the last paragraph of point 1 to the last paragraph of point 2, and explained that the text described general aspects of clinical signs of BSE and thus should remain under point 1.

In point 2, the Code Commission agreed with comments to replace ‘symptoms’ with ‘signs’ as it agreed that a symptom is subjective, whereas a sign is objective and observable, and thus ‘sign’ is relevant for animal diseases. The Commission noted that this change would be made throughout this chapter as well as Chapter 1.8., where relevant.

In the same point, the Code Commission did not agree with a comment to delete ‘all’. It clarified that although all animals listed in points 2(a) to 2(d) should be reported to the Veterinary Authority, not all of these animals need to be tested in laboratories. The Commission highlighted that a Member applying for official recognition of a BSE risk status must describe the procedures in place to identify those animals that have been subjected to laboratory testing from those animals reported to the Veterinary Authority. Applying the same rationale, the Commission agreed with a comment to delete the text after point 2(d).

In points 2(c) and 2(d), the Code Commission did not agree with a comment that the text still lacks clarity or may be too restrictive, as it considered the text clear as written.

In point 3(a), the Code Commission did not agree with a comment to amend text to improve clarity, as it considered the text clear as written.

In point 3(c), the Code Commission did not agree with a comment to add ‘to accurately confirm or rule out the presence of BSE agents’ at the end of the point, as it considered this was implied.

In point 3(d), in response to a comment to add ‘classical’ before ‘BSE positive findings’, the Code Commission reiterated its view that all BSE cases need to be followed up in order to properly address the risk of BSE agents being recycled. The Commission explained that the epidemiological investigation should not be limited to trace-back (to identify the source of the contamination) but should also cover trace-forward (to ensure the BSE case does not enter the animal feed chain). The Commission’s rationale also applies to Article 1.8.6.

**b)****Chapter 1.8. Application for official recognition by the OIE of risk status for bovine spongiform encephalopathy**

Comments were received from Argentina, Burkina Faso, Cameroon, Canada, New Zealand, South Africa, the USA, Members of the OIE Asia, Far East and Oceania Region, the AU-IBAR, the EU and the WRO.

**Article 1.8.1.**

In the first paragraph, the Code Commission agreed with a comment to delete ‘of the cattle (*Bos indicus* and *Bos taurus*) population’ and add ‘(*Bos indicus* and *Bos taurus*)’ after ‘within the cattle’ for consistency with Chapter 11.4.

**Article 1.8.2.**

In point 1(b), the Code Commission did not agree with a comment to delete the second ‘indigenous’, as it considered that the information on the year of birth for each imported case of classical BSE does not provide added value in terms of BSE risk assessment.

**Article 1.8.5.**

In the first and second paragraph of point 2, the Code Commission did not agree with a comment that atypical BSE’s capability of being recycled in a cattle population is negligible if cattle were exposed to feed contaminated with its causal agent. The Commission reiterated that it was presented in the March 2019 report of the *ad hoc* Group on BSE risk assessment and surveillance, as discussed above in Article 11.4.1.

In the first paragraph of point 2(a), the Code Commission did not agree with comments to reinstate ‘stock’ or replace ‘dead animals’ with ‘fallen stock’, and explained that ‘dead animals’ is the term commonly used throughout the *Terrestrial Code*. The Commission did not agree with a comment to replace ‘slaughtered animals’ with ‘slaughtered cattle’, as it considered the change would not provide any additional clarity.

In point 2(a)(i), the Code Commission amended the text in response to comments to improve clarity.

In the third paragraph of point 2(a)(ii), the Code Commission did not agree with a comment to delete ‘(i.e. cattle of any age which were found dead or were killed on a farm, during transportation, at livestock markets or auctions, or at a slaughterhouse/abattoir)’ and to create a Glossary definition for ‘fallen stock’, as it noted that ‘fallen stock’ is a term that is only used in the BSE chapters (Chapter 11.4. and Chapter 1.8.) and therefore does not meet the criteria for creating a Glossary definition.

In the last sentence of the same paragraph, the Code Commission did not agree with a comment that information on the extent and frequency of use of fertilisers or composted materials is not relevant, as it considered that quantitative information is useful to understand this practice.

In point 2(a)(iv), the Code Commission did not agree with a comment to delete ‘(classical or atypical)’ as it considered it necessary to include ‘atypical’ here and reiterated that the recycling of not only classical BSE but also atypical BSE should be avoided and that it is important to consider the potential recycling of all BSE agents, including atypical BSE, in the exposure assessment. The Commission noted that this rationale also applies to similar comments submitted for Article 1.8.5.

In the second indent of point 2(b)(ii), the Code Commission agreed with a comment to delete ‘cross-’ to align with point 1 of Article 11.4.14.

In the third and fourth indents of point 2(b)(ii), in response to a comment to clarify this text, the Code Commission explained that the intention of the third indent is to determine whether commodities with the greatest BSE infectivity are removed from ‘fallen stock’ and that ‘animals condemned at ante-mortem inspection’ are subject to a rendering process, whereas the intention of the fourth indent is to determine how ‘fallen stock’, ‘animals condemned at ante-mortem inspection’ and ‘slaughter waste declared as unfit for human consumption’ are disposed of in case that they include the commodities with the greatest BSE infectivity. To clarify the intention, the Commission proposed some amendments in the fourth indent. 

In the first indent of point 2(b)(vi), in response to a comment to delete ‘or a third party’ and stating that a feed ban is the key risk mitigation measure and should have oversight by the Veterinary or Competent Authority, the Code Commission agreed with the rationale and proposed to add ‘approved’ before ‘third party’.

**Article 1.8.6.**

The Code Commission proposed to amend some wording in this article to ensure alignment with the wording in Article 11.4.18.

In point 3(a), the Code Commission proposed to delete ‘how many are involved in testing BSE samples’ as it considered this text was ambiguous and unnecessary.

In point 4, in response to a comment that the current wording still implies active targeted surveillance and enhanced passive surveillance without a target of an acceptable amount of testing, the Code Commission considered the text clear as written, and stressed that the proposed BSE surveillance focuses on passive surveillance which is a mechanism to demonstrate that the risk of classical BSE is still low. Therefore, all animals listed in points 2(a) to 2(d) of Article 11.4.18. should be reported to the Veterinary Authority, but not all of these animals need to be tested in laboratories.

In Table 1, the Code Commission did not agree with  suggestions to improve clarity of the table, as it considered it clear as written.

In Table 2, in response to a comment to improve clarity of ‘Age (in months) at first detection’, the Code Commission proposed to replace ‘at first detection’ with ‘at the time of reporting’.

In Table 2, in response to concerns that completing this table would be an administrative burden, the Code Commission reminded Members that the information specified in Articles 1.8.2. to 1.8.6. should be provided by Members who apply for official recognition of BSE risk status, and is different from the information that should be provided as part of the annual reconfirmation process. The Commission requested the OIE Secretariat to consider providing more information to Members on the revised annual reconfirmation process to ensure it is well understood.

**c)	Glossary definition for ‘protein meal’**

Comments were received from South Africa, the AU-IBAR and the EU.

The Code Commission did not agree with a comment to add ‘milk and milk products’ to the exception because it considered that it is already clear that ‘milk and milk products’ as per the Glossary definition are not included in the definition for protein meal.

The Code Commission proposed to delete ‘blood and blood products’ (see Article 11.4.1.).

The Code Commission requested the OIE Secretariat to review the use of terms ‘meat-and-bone meal’ and ‘greaves’ throughout the *Terrestrial Code* and report back to the Commission at its February 2022 meeting. At that time the Commission will decide where these terms should be replaced with ‘protein meal’. Once the Commission knows the extent of consequential changes required throughout the *Terrestrial Code*, it will decide whether the Glossary definition for protein meal should be proposed for adoption. The Commission also explained that when ‘protein meal’ is adopted as a Glossary definition, point 4(b) of Article 11.4.1. will be deleted.

The revised Chapter 11.4. Bovine spongiform encephalopathy, Chapter 1.8. Application for official recognition by the OIE of risk status for bovine spongiform encephalopathy, and the proposed Glossary definition for ‘protein meal’ are presented as **Annex 13**, **Annex 14** and in **Annex 4**, respectively, for Member comments and are proposed for adoption at the 89th General Session in May 2022.

6.9.	Theileriosis (Chapter 11.10.) and Article 1.3.2.

Comments were received from New Caledonia, New Zealand, Switzerland, Thailand, the AU-IBAR and the EU.

Background

The revised Chapter 11.10. Infection with *Theileria annulata*, *T. orientalis* and *T. parva* was first circulated for comments in September 2017, following the work of the *ad hoc* Group on Theileriosis that met in February 2017. At the Code Commission’s February 2018 meeting, in response to some comments which questioned the listing of some *Theileria* spp., the review of comments was put on hold while expert advice was sought regarding listing.

At its September 2019 meeting, the Code Commission was informed that *T. orientalis* (Ikeda and Chitose) had been assessed by experts against the criteria for listing in accordance with Chapter 1.2. and were found to meet the criteria for listing (refer to Annex 19 of the Scientific Commission’s February 2019 meeting report). Given that the pathogenic agent was found to meet the criteria for listing, the Code Commission agreed to recommence work on the revised chapter.

At its September 2020 meeting, the Code Commission considered comments received previously on the revised Chapter 11.10. and circulated a revised chapter for comments. 

At its February 2021 meeting, the Code Commission agreed to defer its discussion until its September 2021 meeting when they would have received advice from the Scientific and the Laboratories Commissions on selected comments.

The Code Commission noted that the Scientific Commission had acknowledged inconsistencies in the requirements for disease freedom for vector-borne diseases, including demonstrating the absence of competent vectors. The Code Commission considered this issue and agreed that this issue should be considered further before proposing any specific revisions to relevant new or revised chapters.

Discussion

**Article 1.3.2.**

The Code Commission noted that the listed disease ‘Theileriosis’ in Article 1.3.2. should be amended to ‘Infection with *Theileria annulata*, *T. orientalis* and *T. parva*’ to reflect the recent assessments against the listing criteria in accordance with Chapter 1.2., and proposed to amend Article 1.3.2. accordingly.

**General comments**

In response to a comment to include ‘*T. mutans*’, the Code Commission noted that this species could not be added until it has been assessed against the listing criteria in accordance with Chapter 1.2. The Commission asked that this species be proposed for an assessment. 

**Article 11.10.3.**

The Code Commission, in agreement with the Scientific Commission, did not agree with a comment to add ‘and has considered the presence or absence of competent vectors in the epidemiological situation’ at the end of point (b) and to delete point (c). However, the Code Commission did not agree with a proposal from the Scientific Commission to add a requirement that ‘the country or zone has not reported any case of Theileriosis for at least two years’ to point (c). The Commission agreed that, in accordance with chapters on surveillance, if a country demonstrates the absence of competent vectors for a disease and the vector is  essential for the transmission of the disease, the country should be considered free from the disease without having to demonstrate the absence of cases.

Regarding a comment seeking clarification on the use of terms ‘competent vectors’ and ‘competent tick vectors’ in the *Terrestrial Code* and the inclusion of genera or species of competent vectors in this draft chapter as well as other relevant disease-specific chapters, the Code Commission considered that the term ‘competent’ referred to a vector’s capability to transmit the disease and found no added value on further defining these terms for the purpose of the *Terrestrial Code*. The Commission also explained that it was not always possible to provide a detailed list of competent vectors for every disease and that such a list could even vary by region. It also highlighted that the detailed provisions for surveillance for arthropod vectors is provided in Chapter 1.5. In addition, it encouraged Members to refer to the discussion in item 5.2. of this report, on the recently adopted Chapter 8.18. Infection with *Trypanosoma brucei*, *T.congolense*, *T. simiae* and *T. vivax* and item 4.12. of its February 2021 report. 

**Article 11.10.5.**

In point 2, the Code Commission did not agree with a comment to replace ‘35 days’ with ‘40 days’ to allow for the time taken for testing. The Commission explained that the isolation time was primarily intended to detect potential clinical cases (hence a duration of one incubation period) and that provisions on the testing are described in point 4, not in point 2. In the same point, the Commission did not agree with a proposal to add ‘in a herd with bovines that are free from infection with *Theileria*’ after ‘isolated’ and to delete ‘in and establishment where no case of infection with *Theileria* has occurred during the preceding two years’, as it considered that the establishment for isolation needs to be defined in this point and is clear as written.

In point 3, the Code Commission agreed with a comment to replace ‘entrance of the isolation establishment’ with ‘time of entry to the isolation herd’ as it considered that the timing of the acaricide treatment before export is critical but proposed to replace herd with establishment for consistency with wording used in this chapter.

In point 4, with regard to a comment to replace ‘serological and agent identification tests’ with ‘serological or agent identification tests’, the Code Commission noted that the Laboratories Commission had considered that both tests are necessary as neither test is very sensitive. However, the Code Commission acknowledged that Table 1 of Chapter 3.4.14. in the *Terrestrial Manual* recognises some serological and agent identification tests as ‘recommended method’ or ‘suitable method’ for individual animal freedom from infection prior to movement. Therefore, the Code Commission requested that this issue be raised with the Laboratories Commission and report back to the next meeting of the Code Commission.

In the same point, the Code Commission, in agreement with the Laboratories Commission, agreed with a comment that it is impractical to have testing five days prior to shipment, and proposed amended text.

The revised Chapter 11.10. Infection with *Theileria annulata*, *T. orientalis* and *T. parva* and the revised Article 1.3.2. are presented as **Annex 15** and **Annex 16** respectively for Member comments and are proposed for adoption at the 89th General Session in May 2022.

6.10.	Trichomonosis (Chapter 11.11.)

Comments were received from Australia, New Zealand, Switzerland and the EU.

Background

At its September 2020 meeting, the Code Commission revised Articles 11.11.2., 11.11.3. and 11.11.4., to align recommendations with those in Chapter 3.4.15. on ‘Trichomonosis’ of the *Terrestrial Manual*. The amendments made by the Commission were based on the advice of the Reference Laboratory experts for Trichomonosis. The revised articles were circulated for comment in its September 2020 report. However, due to time constraints, the Commission deferred discussions until its September 2021 meeting. 

Discussion

General

In alignment with the changes made in the *Terrestrial Manual*, the Code Commission proposed to replace ‘agent identification test’ with ‘test for the detection of the agent’ throughout the text. 

Article 11.11.2.

In point 2, in response to a comment seeking clarification as to the time period for which no case of trichomonosis has been reported in the herd, the Code Commission explained that this provision meant that the animals in the herd have never had a case of trichomonosis. The Commission also wished to clarify that ‘herd’ (a Glossary defined term) refers to a group of animals, and should be distinguished from ‘establishment’ (a Glossary defined term) which refers to the premises where animals are kept. In point 3, the Commission did not agree with a comment to reinstate ‘of vaginal mucus’, and reminded Members that details of the appropriate samples for the recommended diagnostic tests are provided in Chapter 3.4.15. of the *Terrestrial Manual* and such details are not included in the *Terrestrial Code*. 

The Code Commission agreed that points 2 and 3 should be undertaken in conjunction, and thus proposed to delete ‘and/or’ after point 2. 

Article 11.11.3.

In point 5, the Code Commission did not agree with a comment to reinstate ‘of preputial specimens’ and reminded Members that details of the appropriate samples for the recommended diagnostic tests are provided in Chapter 3.4.15. of the *Terrestrial Manual*. 

The Code Commission proposed to delete ‘and/or’ and to add ‘AND’ after point 2, noting that points 1 and 2 have to be undertaken in conjunction with either of points 3, 4 and 5. 

Article 11.11.4.

The Code Commission proposed to move point 5 to a new point 1 for a more logical flow.

Noting that the original points 3 and 4 have to be undertaken in conjunction and that it was unnecessary to perform a test for the detection of the agent for donor animals fulfilling the original points 1 and 2, the Code Commission proposed to combine the original points 3 and 4 into new point 4.

The revised Chapter 11.11. Trichomonosis is presented as Annex 17 for Member comments and is proposed for adoption at the 89th General Session in May 2022.

6.11.	Terminology: Use of the term ‘sanitary measure’ 

Background

Following the adoption of the Glossary definition of ‘sanitary measure’ at the 87th General Session, the Code Commission requested the OIE Secretariat to assess whether the terms ‘sanitary measure’ and ‘biosecurity’ have been used appropriately in the *Terrestrial Code.*

Discussion

In view of the planned work to develop a new chapter on biosecurity, the Code Commission agreed to include the review of the use of the term ‘biosecurity’ as part of this work.

Regarding the review of the term ‘sanitary measure’, the Code Commission noted that this term has not been appropriately used in the following articles and proposed the following amendments. 

*Veterinary legislation (Chapter 3.4., Article 3.4.5.)*

In point 1(d), the Code Commission proposed to replace ‘sanitary measures’ with ‘measures and procedures’. 

*Official health control of bee diseases (Chapter 4.15., Article 4.15.6.)*

In point 1, the Code Commission proposed to replace ‘sanitary measures’ with ‘procedures’. In line with this amendment, the Commission also proposed to replace ‘measures’ in points 2 and 3 with ‘procedures’.

*Control of biological hazards of animal health and public health importance through ante-and post-mortem meat inspection (Chapter 6.3., Article 6.3.3.)*

In the first sentence, the Code Commission proposed to replace ‘sanitary measures’ with ‘hygiene practices and sanitation’, in accordance with language used by the Codex Alimentarius Commission. 

The revised Articles 4.15.6. of Chapter 4.15. Official health control of bee diseases and Article 6.3.3. of Chapter 6.3. Control of biological hazards of animal health and public health importance through ante- and post-mortem meat inspection, are presented as **Annex 18**, and are proposed for adoption at the 89th General Session in May 2022. 

**7.	Texts circulated for comments**

7.1.	Infection with foot and mouth disease virus (Chapter 8.8.)

Comments were received from Australia, Brazil, Canada, Chinese Taipei, Japan, New Caledonia, New Zealand, Switzerland, Thailand, the USA, Zimbabwe, Members of the OIE Americas Region, the AU-IBAR and the EU.

Background

A revised Chapter 8.8. Infection with foot and mouth disease virus has been circulated three times for Member comments, the last time in the Code Commission’s September 2020 report. At its February 2021 meeting, the Code Commission agreed to defer discussions on this chapter, noting that it was awaiting the opinion of the Scientific Commission on some points, and the recommendations of a joint TAHSC-SCAD Taskforce (the Taskforce) to clarify the term ‘bovine’ as used in the chapter, and to review the use of the terms ‘case’, ‘transmission’, ‘case with clinical signs’ and ‘infection’ in the chapter.

Between June and July 2021, a second meeting of the Taskforce was convened to address the implications of introducing vaccinated animals into an FMD-free country (or zone) where vaccination is not practised (not for direct slaughter), to develop an article on the establishment of a protection zone in line with recently adopted Article 4.4.6., and to address the incursion of African buffalo into an FMD-free country or zone. The Code Commission encouraged Members to refer to the September 2021 report of the Scientific Commission for detailed information on the rationale for some recommendations of the Taskforce.

Discussion

The Code Commission considered Member comments received in February 2021, the recommendations of the Taskforce and a proposal from the OIE Secretariat on the harmonisation of requirements for official recognition and maintenance of free status and endorsement and maintenance of official control programmes to align with recently adopted revisions in Chapters 14.7. Infection with peste des petits ruminants virus and 15.2. Infection with classical swine fever virus.

The Code Commission noted that the *ad hoc*Group on Foot and mouth disease virus had also proposed provisions for the importation of meat of susceptible captive wild animals and wild animals, and meat of domestic small ruminants and pigs from countries or zones infected with FMD virus, where an OIE endorsed official control programme for FMD exists, that had been endorsed by the Scientific Commission at its February 2021 meeting. The Code Commission agreed it will review the recommendations of the *ad hoc*Group at its next meeting in February 2022. 

The Code Commission noted that some comments, such as those related to safe commodities (Article 8.8.1bis.) received in February 2021, were not addressed at this meeting and would be followed-up with, where necessary (within the framework of general discussions on safe commodities Standard Operating Procedure (SOP), when it continues its discussion on Chapter 8.8. at its next meeting in February 2022.

General comments

With regard to the use of the terms ‘infection’ and ‘transmission’, the Taskforce had proposed to keep both terms when describing the demonstration of freedom from FMD: no infection with FMDV in unvaccinated populations and no transmission of FMDV in vaccinated populations. The Taskforce also agreed on the importance of clinical surveillance, mainly in unvaccinated populations, and kept references to ‘clinical signs’ when it was appropriate but removed them when unnecessary. The Taskforce had also proposed to replace ‘case’ with ‘infection with FMDV’ for simplification and harmonisation purposes. The Code Commission agreed with the recommendations of the Taskforce and applied these changes throughout the text where relevant.

The Code Commission agreed with the recommendations of the Taskforce to replace ‘bovines’ with ‘cattle’ for consistency with Chapter 11.4. Bovine spongiform encephalopathy. Consequently, the Commission replaced the term ‘bovines’ by cattle in different parts of the chapter and made reference to water buffaloes in addition to cattle where applicable. 

Additionally, the Code Commission reviewed the harmonisation changes and proposed amendments to Articles 8.8.2., 8.8.3., 8.8.5. and 8.8.39. 

The Code Commission considered that the proposed amendments to the above points would address selected comments on the text.

**Article 8.8.1.**

In point 2, the Code Commission agreed with the recommendations of the Taskforce and proposed to delete ‘suborder ruminantia and of the’, and to add ‘and the subfamilies *bovinae, caprinae*and c*ervidae*’**to better clarify the scope of susceptible animals. It also agreed with the proposal to add a new point 2bis to clarify that the term ‘cattle’ as used in the chapter means animals of the species *Bos taurus*or *Bos indicus.*

In view of the above amendment, the Code Commission did not agree with a comment to add ‘cloven-hooved’ before ‘animals’.

In point 4, the Code Commission proposed to add ‘or any cause for suspicion of previous association or contact with FMDV’ to clearly distinguish the use of the term ‘infection’ from ‘transmission’ in the chapter, and to clarify that transmission could occur not just in the absence of clinical signs, but also if there was an epidemiological link with the FMDV.

In point 6, in response to a comment requesting to provide further elaboration on the persistence and shedding of FMDV and the duration of carrier status, the Code Commission reiterated that it considered this addition to be too detailed for a chapter in the *Terrestrial Code*, and that such information would be more appropriate in the *Terrestrial Manual*. 

In response to a query on the inclusion of point 7 concerning reference to the *Terrestrial Manual*, the Code Commission confirmed that it is a convention to include this point in the disease-specific chapters of the *Terrestrial Code*and it provides a clear link with the *Terrestrial Manual*when appropriate.

**Article 8.8.1bis.**

In point 1, in response to a comment regarding the inclusion of the UHT milk on the list of safe commodities, the Code Commission clarified that this was aligned with the current version of the OIE Technical Disease Card on FMD.

In point 3, the Code Commission proposed to replace ‘meat and bone meal and blood meal’ with ‘protein meal’ for consistency with the proposed new Glossary definition for protein meal (refer to item 6.8. of this report). 

In response to a comment requesting to include the term ‘rendering’ in the Glossary, the Code Commission discussed the proposal and decided to consider this request at its next meeting.

**Article 8.8.2.**

In paragraph 3, the Code Commission, in agreement with the Scientific Commission, did not agree with a comment to relocate the penultimate paragraph of Article 8.8.3. to this paragraph. The Code Commission considered this comment to be addressed with the newly proposed Article 8.8.5bis. on Establishment of a protection zone within a country or zone free from FMD.

In points 1 to 4, the Code Commission reminded Members that the proposed amendments were made as part of the harmonisation work in accordance with recently adopted Chapters 14.7. and 15.2.

In point 5, the Code Commission agreed with the recommendations of the Taskforce, and proposed to delete ‘measures to prevent the introduction of vaccinated animals, except in accordance with Articles 8.8.8., 8.8.9., 8.8.9bis., 8.8.11., and 8.8.11bis. have been effectively supervised’. The Commission noted that the Taskforce considered that the provisions in the draft revised Articles 8.8.11. and 8.8.12. provided the necessary assurances for the safe trade of vaccinated animals into a free country or zone where vaccination is not practised. 

The Code Commission agreed with the proposal of the Taskforce to add point 6 to reflect that vaccination should remain prohibited in the country or zone free from FMD where vaccinated is not practised, although it may have subpopulations of animals that are vaccinated due to the possibility of introducing vaccinated animals.

In the sixth indent, the Code Commission, in agreement with the Scientific Commission, did not accept a comment to add a parenthesis ‘including virological and serological surveillance as appropriate for African buffalo within the collection’, noting that the zoological collection is already subject to surveillance in accordance with point 4(b) which includes surveillance in accordance with Articles 8.8.40. to 8.8.42. demonstrating no infection or transmission of FMDV. Thus, the same conditions would apply to the African buffalo.

Regarding comments pertaining to the possible incursion of stray African buffalo, the Code Commission noted that the Taskforce had recommended specific conditions to be met in order that a country or zone free from FMD may maintain its free status despite an incursion of African buffalo. While the Code Commission considered that the conditions proposed by the Taskforce were logical, it agreed that such provisions were outside the scope of the *Terrestrial Code*, i.e. to provide conditions for specific epidemiological situations such as incursions of African buffalo from neighbouring infected countries or zones. Consequently, the Code Commission proposed to include a statement that it was possible for a country or zone free from FMD to maintain its free status despite an incursion of African buffalo from a neighbouring infected country or zone provided relevant conditions are met and evidence has been submitted to and accepted by the OIE as part of the reassessment of official status in such circumstances, without prescribing the specific conditions. It would be up to the assessment of the Scientific Commission, who is responsible for evaluating a Member’s official disease status to determine whether the free status can be maintained. 

**Article 8.8.3.**

The Code Commission did not agree with a comment to include the reference of point 6 of Article 8.8.40. at the end of the point 1(e), as it considered this to be implicit. 

The Code Commission did not agree with comments to move the penultimate paragraph of Article 8.8.3. to original paragraph 2 (now deleted). It considered this comment would be addressed with the newly proposed Article 8.8.5bis. on Establishment of a protection zone within a country or zone free from FMD.

**Article 8.8.3bis.**

The Code Commission agreed with the recommendation of the Scientific Commission that the two paragraphs at the end of Article 8.8.3. that describe the provisions for changing the vaccination status of a country or zone free from FMD do not fit in Article 8.8.3. and are better placed as a separate Article 8.8.3bis. on Transition of vaccination status in a country or zone free from FMD.

**Article 8.8.4. and Article 8.8.4bis.**

The Code Commission agreed with the Taskforce proposal to delete point 2(a) given that infection with FMDV in the next point would include a ‘case’. In addition, the Commission proposed to replace ‘detected’ with ‘occurred’ in point 2(a) of both articles. 

**Article 8.8.5bis.**

The Code Commission noted that the Taskforce had proposed a new Article 8.8.5bis. on Establishment of a protection zone within a country or zone free from FMD in view of recently adopted Article 4.4.6. 

**Article 8.8.6.**

The Code Commission agreed with a comment to add ‘previously’ before ‘free from FMD’ in the title of the article for consistency with the text within the article and in line with the harmonisation work done for Chapter 15.2. on the equivalent article. 

In paragraph 1, in response to a comment to consider revising the text to address the possibility of establishing multiple containment zones where outbreaks are not epidemiologically linked, the Code Commission agreed with the Scientific Commission that this would be a very exceptional situation and that the current text does not preclude this possibility as long as evidence demonstrates that the incursions are not epidemiologically linked. Therefore, it did not agree to make any further changes to this paragraph. 

In paragraph 2, the Code Commission did not agree with comments requesting to state that the containment zone is not considered to be established until approved by the OIE as this is already mentioned in paragraph 3.

In response to a comment querying the deletion of point 3 of paragraph 2, the Code Commission reiterated its explanation in its September 2020 meeting report that the deletion was to minimise duplication with provisions already in point 3 of Article 4.4.7. and to harmonise with other disease-specific chapters.

In paragraph 3, the Code Commission, in agreement with the Scientific Commission, did not agree with comments to add a reference to Article 4.4.7. noting that the first two paragraphs of Article 8.8.6. make a reference to Article 4.4.7. 

In paragraph 5, the Code Commission agreed with comments and corrected the reference from point 4(a) to point 4(b). 

In the last paragraph, comments were received requesting to increase the time period for the recovery of free status of the containment zone to be achieved from 12 months to 24 months. The Code Commission agreed with the proposal of the Scientific Commission to amend the recovery time to 18 months, in view of the opinion of the Scientific Commission that considering the waiting periods for recovery of status under Article 8.8.7., particularly point 3(b) in which the waiting period is 12 months after the detection of the last case, the recovery of free status of the containment zone was not possible to achieve if the containment zone was established following point 4(b) of Article 4.4.7. It noted the rationale of the Scientific Commission that the intention of the containment zone is for it to be quickly established in the event of FMD outbreaks in a previously free country or zone, to control and eradicate the disease and recover the status as soon as possible. The Code Commission also noted its ongoing discussion with the Scientific Commission concerning the time limit of the containment zone (refer to item 5.2. of this report). 

**Article 8.8.7.**

The Code Commission noted that its proposed amendments to the beginning of points 1 and 2 would address a comment requesting to harmonise the wording used.

Articles 8.8.8. and 8.8.9. (deleted)

In response to comments requesting to include the same requirements for a containment zone as an infected zone, notably in points 1, 2 and 3 of Article 8.8.8., the Code Commission, in agreement with the Scientific Commission, proposed to delete Article 8.8.9. and to include the containment zone in Article 8.8.8. The Code Commission highlighted that a containment zone is considered an infected zone, and therefore added ‘including containment zone’ to the title of Article 8.8.8.

The Code Commission, in agreement with the Scientific Commission, did not agree with a comment to develop different conditions for the inner and outer zones of a containment zone as the outer zone is still part of the risk management area and therefore considered infected as part of the containment zone.

**Article 8.8.9bis and Article 8.8.11.**

The Code Commission did not agree with a comment to delete ‘or not’ in the title of the article and clarified that vaccinated animals may exist in a zone free from FMD where vaccination is not practised, either because the zone has been recently recognised as free without vaccination or as a result of movements in accordance with Article 8.8.11.

In paragraph 1, the Code Commission agreed with comments to delete ‘nearest’, noting that the nearest slaughterhouse/abattoir may not be the most appropriate for slaughter to take place. However, it did not agree with a comment to delete ‘designated’.

In response to a comment requesting to include a new article to provide for the movement of animals from a zone free from FMD where vaccination is practised transiting through a zone free from FMD where vaccination is not practised for export purposes, the Code Commission noted that with the change in Article 8.8.2. that allows the possibility of free status without vaccination to be maintained with the introduction of vaccinated animals into a country or zone free from FMD where vaccination is not practised, the proposal is no longer relevant. Nonetheless, the Code Commission agreed with the recommendation of the Scientific Commission to clarify that whilst vaccinated animals are transiting through an FMD free zone where vaccination is not practised, they should not be in contact with any susceptible animals during transportation to the place of shipment, and proposed a new point 6 in Article 8.8.11.

**Article 8.8.11bis.**

In point 3, the Code Commission did not agree with a comment to replace ‘vehicles/vessels’ by ‘containers’ as it considered that ‘vehicles/vessels’ may be properly sealed. 

**Article 8.8.12.**

In point 5, the Code Commission acknowledged that the text as written could be confusing, and proposed to split the point into two parts so that it was clear that if the animals were isolated in an establishment that is not a quarantine station, there should be no FMD case within a 10-km radius of the establishment. 

**Articles 8.8.15. and Article 8.8.16.**

In point 1(c)(ii), the Code Commission, in agreement with the Scientific Commission, did not agree with comments to specify the use of a DIVA assay, and clarified that this point was applicable to donor males that have not been vaccinated. Consequently, the Code Commission proposed to add ‘have not been vaccinated’ at the beginning of the sentence.

In the same point, the Code Commission also noted that whilst there was a defined lower limit of 21 days after collection of semen for testing the donor males for antibodies, an upper limit was not provided. The Code Commission agreed with the recommendation of the Scientific Commission to provide an upper limit of 60 days, noting that the rationale for this proposal was provided in the February 2020 report of the Scientific Commission.

**Article 8.8.26. (deleted)**

In response to a comment requesting the reinstatement of Article 8.8.26., the Code Commission clarified that it had proposed to delete this article after considering the inclusion of ‘meat-and-bone meal’ as a safe commodity in Article 8.8.1bis. The Commission further clarified that the term ‘protein meal’ has been proposed to replace ‘meat-and-bone meal’ (refer to item 6.8. of this report).

**Article 8.8.31.**

In point 1, in response to a comment requesting further information on ‘any equivalent treatment’, the Code Commission clarified that the current recommendation on canning provides the reference point for the selection of other alternative treatments. 

**Article 8.8.35. and Article 8.8.36.**

The Code Commission noted that Articles 8.8.35. and 8.8.36. concerned inactivation parameters for FMDV and that there should not be any differentiation depending on end-use, i.e. for human or animal consumption. In view of this, the Commission proposed to delete Article 8.8.36., and to have a single Article 8.8.35. on the inactivation of FMDV in milk. 

Given the above amendment, the Code Commission noted that a comment seeking further specification on the time lapse requirement for the 72°C and a definition for desiccation in point 2 of Article 8.8.36. was no longer relevant. Nonetheless, the Code Commission would refer the Member to the Scientific Commission report of February 2021 which addressed this question.

**Article 8.8.39.**

The Code Commission proposed amendments to the article as part of the harmonisation work for disease-specific chapters for which the OIE grants official status recognition, in accordance with recently adopted Chapters 14.7. and 15.2.

**Article 8.8.40.**

In paragraph 4 of point 2, the Code Commission clarified that the addition of the text ‘previously or newly introduced vaccinated animals should be considered in the strategy and design of the surveillance programme’ was in response to the recommendation of the Taskforce to allow for the introduction of vaccinated animals into a country or zone free from FMD where vaccination is not practised. The Taskforce had highlighted the need to modify the surveillance strategy and design to demonstrate the absence of FMDV in the different subpopulations (vaccinated and unvaccinated) following the introduction of vaccinated animals into a country or zone free from FMD where vaccination is not practised. In such a situation, the Member concerned should demonstrate the absence of infection with FMDV in the unvaccinated subpopulation, and that there has been no transmission of FMDV in the newly introduced or previously vaccinated subpopulation. Evidence to demonstrate this should be documented and included in the dossier for the official recognition and maintenance of free status.

The Code Commission agreed with a comment that serological surveys should not only be performed for non-vaccinated susceptible species that do not show reliable clinical signs, but also to susceptible species that show reliable clinical signs but which are not subject to regular and frequent observation such that clinical signs could be missed. Therefore in points 7(a)(iii), 7(b)(iv) and 8(b)(iv), the Code Commission, in agreement with the Scientific Commission, proposed to include ‘husbandry systems that do not allow sufficient observation’. 

In the first indent of point 7(c)(i), in response to comments regarding vaccine matching and potency, the Code Commission agreed with the Scientific Commission that the focus should be on the probability of protection and the different ways to demonstrate an adequate level of protection. The Code Commission agreed with the Scientific Commission’s proposed amendment to better clarify that vaccine with high potency of at least 6PD50 or equivalent is one of the ways to achieve this protection. 

In the second indent of point 7(c)(ii), the Code Commission, in agreement with the Scientific Commission, did not accept comments to delete ‘indirect serological assay (i.e. sera from vaccinated *animals* tested against the field virus)’, noting that this is a way to demonstrate an adequate level of protection.

The revised Chapter 8.8. Infection with foot and mouth disease virus is presented as **Annex 19** for Member comments.

**8.	Date of next meeting**

The next meeting will be held from 1 to 11 February 2022.

__________________________

.../Annexes

OIE •12, rue de Prony • 75017 Paris • FranceTel.: 33 (0)1 44 15 18 88 • Fax: 33 (0)1 42 67 09 87 • www.oie.int • oie@oie.int

2	*OIE Terrestrial Animal Health Standards Commission/September 2021*

*OIE Terrestrial Animal Health Standards Commission/September 2021*3

# image1.gif