Brussels, 16.1.2008

SEC(2008) 37

COMMISSION STAFF WORKING DOCUMENT

Written comments of the Community on the OIE Aquatic Animal Health Code following the Annual General Session 2007 and prior to the next Aquatic Animal Commission meeting March 2008.

EXPLANATORY MEMORANDUM

The OIE Aquatic Animal Health Standards Commission (AAC) met at the OIE Headquarters in Paris in October 2007.

These proposals for modifications are for eventual adoption or consideration at the next General Session in May 2008.

The Community comments need to reach the OIE Headquarters by 4 February 2008 in order to be considered at the next meeting of the Commission in March 2008.

The Commission therefore proposes to the Council to authorise the Commission to present to the OIE, as since 1995, the following written comments in the Annex before 4 February prior to the meeting referred to above. This is in order to allow the OIE to take the Community comments into account during their meeting in March, prior to submission of the final version at the General Session in May 2008. The cover letter to be sent with our response is attached at Annex A (Doc D/prm D1/2007/D/xxx)).

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

(...PICT...)

| UNION EUROPEENNE |

Bruxelles, le

D(2007) prm D1/2007/D/xxx)

Dear Bernard,

Please find attached as an annex to this letter the Community comments on the report of the meeting of Code Commission with reference to certain Chapters in the OIE Aquatic Animal Health Code. In order to facilitate the examination of the comments of the Community, they have been incorporated in boxes into the OIE reports. In this context, the Community thanks the OIE for providing the electronic version of the Report.

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

Vida Čadonič-Špelič Paola Testori Coggi

Chief Veterinary Officer Deputy Director General

Enclosures: 1

Copy: All CVOs Member States, Iceland, Norway, and Switzerland

Dr. B. Vallat

Directeur général OIE

12 Rue de Prony

F-75017 PARIS

(...PICT...)

Original: English

October 2007

report of the MEETING of the

OIE aquatic animal health STANDARDS COMMISSION

Paris, 1-5 October 2007

_______

The OIE Aquatic Animal Health Standards Commission (hereafter referred to as the “Aquatic Animals Commission”) met at OIE headquarters from 1 to 5 October 2007.

Details of participants and the adopted agenda are at Annexes I and II.

Dr Eva-Maria Bernoth, President of the Aquatic Animals Commission, opened the meeting by reminding members of the extensive work programme for the meeting. Dr Sarah Kahn welcomed the Aquatic Animals Commission members on behalf of Dr Bernard Vallat, Director General, who was unable to attend the opening of the meeting. Dr Kahn conveyed the continuing appreciation of the OIE for the efforts of Aquatic Animals Commission members and the good progress being made in the work programme.

Dr Vallat joined the last day the Aquatic Animals Commission for a discussion of strategic priorities. Dr Vallat indicated that key priorities for the Aquatic Animals Commission include the harmonisation of the OIE Terrestrial Animal Health Code (hereafter referred to as the “Terrestrial Code”) and the OIE Aquatic Animal Health Code (hereafter referred to as the “Aquatic Code”), taking into account the current work to divide the Terrestrial Code into two volumes. In response to Dr Bernoth’s update on progress in developing guidelines for aquatic animal welfare, Dr Vallat confirmed that this topic is sensitive and OIE Members will have diverse opinions. He indicated that the concept should be maintained, even if the recommendations are developed over a period of time. Dr Vallat underlined the importance of the OIE PVS Tool and procedures, and urged the Aquatic Animals Commission to include this as an important work priority. Finally, Dr Vallat reminded the Aquatic Animals Commission of current developments in the inspection of aquatic products for human consumption. In many countries, the official Veterinary Services are responsible for the inspection of aquatic products. Hazards to human health that may be associated with aquatic products include veterinary drug residues and microbial contamination, e.g. Salmonella spp. The Director General urged the Aquatic Animals Commission to involve itself in the OIE’s work on critically important antimicrobials for use in aquaculture animals, perhaps via the establishment of an ad hoc Group, with support from the Scientific and Technical Department. The auditing of inspection systems for aquatic animals and their products is another area for attention.

The Aquatic Animals Commission recognised the contribution of the following Members in providing comments: Australia, Canada, European Union (EU), Japan, New Zealand, the United States of America; and the OIE Reference Laboratory for Infection with Mikrocytos mackini. The President expressed her disappointment at the low number of Members submitting comments and will address this point at the 76th General Session.

The outcome of the Aquatic Animals Commission’s work is presented as Annexes III to XX to this report.

Members are invited to submit their comments to the OIE on Annexes III to XVII of this report prior to 4 February 2008. The comments should be sent preferably by electronic mail to the following address: trade.dept@oie.int. The Aquatic Animals Commission will address the comments received at its next meeting.

The table below summarises the texts – as presented in the Annexes – that are presented for Members’ comment, with a view to proposing them for adoption to the OIE International Committee for adoption at the 76th General Session, depending on comments received (first part), and texts for Members’ information (second part).

Community comment

The Community appreciates the efforts done by the OIE AAC with respect to submitting the report in a reasonable time after the AAC meeting.

However the Community expects that the OIE submits the outcome of the March 2008 meeting as soon as possible after the meeting, in order to allow EU member states to establish their position before the General Session in May 2008.

Annexes for Members’ comments (deadline 4 February 2008) | Annex number |

Definitions (Ch. 1.1.1.) | Annex III |

Diseases listed by the OIE (Ch. 1.2.3.) | Annex IV |

General obligations (Ch. 1.3.1.) | Annex V |

Guidelines for import risk analysis (Ch 1.4.2.) | Annex VI |

Recommendations for transport (Ch 1.5.1.) | Annex VII |

Infectious myonecrosis (Ch 2.3.9.) | Annex VIII |

White tail disease (Ch 2.3.11.) | Annex IX |

Infection with Mikrocytos mackini (Ch. 2.2.5.) | Annex X |

Gyrodactylosis (Gyrodactylus salaris) | Annex XI |

Introduction to the OIE Guidelines for the Welfare of Live Aquatic Animals (Ch X.X.X.) | Annex XII |

Guidelines on the control of aquatic animal health hazards in aquatic animal feed (Ch. X.X.X.) | Annex XIII |

Infection with Batrachochytrium dendrobatidis (Ch. 2.4.1.) | Annex XIV |

Infection with ranavirus (Ch. 2.4.2.) | Annex XV |

Guidelines on the handling and disposal of carcasses and wastes of aquatic animals (Ch X.X.X.) | Annex XVI |

Guidelines for aquatic animal health surveillance (Ch. X.X.X.) | Annex XVII |

Annexes for Members’ information | Annex number |

Report of the ad hoc Group on Aquatic Animal Feeds | Annex XVIII |

Report of the ad hoc Group on Amphibian Diseases | Annex XIX |

Work Plan | Annex XX |

1. Activities and progress of ad hoc Groups

The Aquatic Animals Commission noted the progress made in three ad hoc Groups and the President thanked the chairmen of these Groups (Dr Hill and Professor Katunguka-Rwakishaya) for their contributions. The outputs of these meetings are presented in items 2.2., 2.12, 2.13 and 6.2:

· Ad hoc Group on Aquatic Animal Health Surveillance, 18-20 July 2007

· Ad hoc group on Aquatic Animal Feeds, 29-31 August 2007

· Ad hoc group on Amphibian Diseases, 5-7 September 2007

2. Aquatic Animal Health Code (the Aquatic Code)

2.1. Definitions (Chapter 1.1.1.)

Community comment

The Community has strong reservations with the proposed definition of infestation. Please, see the comments in the specific chapter.

The Aquatic Animals Commission discussed comments from the United States of America on the definition of ‘infestation’ and took into account the proposed definition in the Terrestrial Animal Health Code (the Terrestrial Code) of the term ‘infection’. The Aquatic Animals Commission decided to amend the definition as proposed by the United States of America. The Aquatic Animals Commission modified several other definitions, for example to take into account the inclusion of amphibians into the remit of the OIE and suggestions by the ad hoc Group on Aquatic Animal Health Surveillance, and to delete definitions of terms not subsequently used in the Aquatic Code. Amendments made during this meeting (October 2007) are shown in the usual manner as double underline and strikeout.The amended chapter is at Annex III for Members’ comment, with a view to proposing it to the International Committee for adoption at the 76th General Session in May 2008.

The Aquatic Animals Commission discussed recommendations of an OIE expert on improving the consistency between the Aquatic Code and the Terrestrial Code. The Aquatic Animals Commission noted that a number of modifications are proposed to definitions in the Terrestrial Code and decided to await endorsement of these proposals by Members before considering changes to the definitions in the Aquatic Code.

2.2. Diseases listed by the OIE (Chapter 1.2.3.)

Dr Hill presented disease listing assessments carried out by the ad hoc Group on Amphibian Diseases.

The ad hoc Group had concluded that two diseases of amphibians met the OIE listing criteria: infection with Batrachochytrium dendrobatidis and infection with ranavirus. The assessment is provided in Annex IV of the report of the ad hoc Group (see full report at Annex XIX for Members’ information). The Aquatic Animals Commission agreed to propose those diseases for listing. The updated chapter on diseases listed by the OIE is at Annex IV for Members’ comment, with a view to proposing it them to the International Committee for adoption at the 76th General Session in May 2008. Amendments made during this meeting (October 2007) are shown in the usual manner as double underline and strikeout.

The Aquatic Animals Commission considered Australia’s comments on abalone viral mortality and on abalone viral ganglioneuritis. Dr Berthe briefed the Aquatic Animals Commission on the complexity of these diseases and suggested that an ad hoc Group be convened to address all related matters. The Aquatic Animals Commission agreed with this recommendation. The Aquatic Animals Commission proposed that the Director General convene such an ad hoc Group. The Aquatic Animals Commission decided to refer Australia’s comments to this ad hoc Group.

A re-assessment of the three crustacean diseases still under study, necrotising hepatopancreatitis (NHP), hepatopancreatic parvovirus disease (HPVD) and Mourilyan virus disease (MoVD), will be referred to the ad hoc Group for the Listing of Crustacean Diseases, together with Members’ comments on NHP, HPVD and MoVD. The ad hoc Group will also review the currently listed diseases, spherical baculovirosis, and tetrahedral baculovirosis, as to whether they still meet the criteria for listing, which had previously been questioned by Thailand.

2.3. Obligations and ethics in international trade (Section 1.3.)

The Aquatic Animals Commission considered comments submitted by an OIE expert to improve consistency between the Aquatic Code and the Terrestrial Code. The Aquatic Animals Commission noted that the two Codes are consistent as regards the principle that trade measures should only be imposed in regard to diseases that do not occur in the importing country or, in the case of diseases that occur in importing country, for diseases that are the subject of official controls. The Aquatic Animals Commission noted that several of the expert’s recommendations would need to await the completion of work on restructuring the Terrestrial Code into two volumes. Nonetheless, the Aquatic Animals Commission amended text in Section 1.3 for consistency with the Terrestrial Code. Amendments made during this meeting (October 2007) are shown in the usual manner as double underline and strikeout. The amended text is at Annex V for Members’ comments, with a view to proposing it to the International Committee for adoption at the 76th General Session in May 2008.

2.4. Zoning and Compartmentalisation (Chapter 1.4.4.)

2.5. Aquatic animal health measures applicable before and at departure (Chapter 1.5.2.)

2.6. Aquatic animal health measures applicable on arrival (Chapter 1.5.5.)

For these three agenda items, the Aquatic Animals Commission considered comments of an OIE expert and recent work of the Terrestrial Commission on relevant Terrestrial Code Chapters (Chapter 1.3.5., Chapter 1.4.1., Chapter 1.4.4.). Given the changes proposed to the structure of the Terrestrial Code, the Aquatic Animals Commission decided to defer detailed consideration of these chapters until its next meeting.

2.7. Risk analysis: Guidelines for import risk analysis (Chapter 1.4.2.)

The Aquatic Animals Commission considered the comments provided by an OIE expert and modified Article 1.4.2.4. accordingly. Amendments made during this meeting (October 2007) are shown in the usual manner as double underline and strikeout. The amended text is at Annex VI for Members’ comments, with a view to proposing it to the International Committee for adoption at the 76th General Session in May 2008.

2.8. Recommendations for transport (Chapter 1.5.1.)

Dr Keren Bar-Yaacov (OIE Delegate for Norway) joined the meeting for this item and informed the Aquatic Animals Commission of the background to the text, drafted by Norway, on biosecurity risks during transport of fish by sea. The Aquatic Animals Commission thanked Dr Bar-Yaacov for this very helpful contribution and, after modifying some points in the draft text, agreed that this draft chapter should be sent to Members for consideration. Amendments made during this meeting (October 2007) are shown in the usual manner as double underline and strikeout. The amended text is at Annex VII for Members’ comments, with a view to proposing it to the International Committee for adoption at the 76th General Session in May 2008.

2.9. Disease chapters

Community comment

The Community would agree with the proposed chapters. However, we would like that the OIE takes the comments to the specific chapters into account.

There is an increased concern on how to deal with the imports of aquaculture animals vaccinated against some of the disease listed by the OIE such as Infectious salmon anaemia or Koi carp herpes virus.

To avoid trade disruptions ensuring at the same time a high level of protection, we would suggest to the OIE AAC to include in its working programme how to deal with the trade of aquaculture animals vaccinated against any of the currently listed diseases.

2.9.1. Members’ comments on draft disease chapters

The Aquatic Animals Commission discussed at some length the issue of defining and re-establishing (after a breakdown) the disease free status of a compartment. The Aquatic Animals Commission noted the EU comments but have concerns that these comments only apply in the situation where the compartment is a specific establishment as opposed to compartments comprising several establishments. The Aquatic Animals Commission was also concerned that the proposed text does not address the need to review the biosecurity plan to obtain an understanding of why the breakdown had occurred, and to rectify the fault(s). The Aquatic Animals Commission noted this is a difficult area, and Dr Hill will develop text for discussion at its next meeting.

The Aquatic Animals Commission considered a Member’s comment on the packaging of processed products for retail trade. The International Committee had adopted this text in May 2007, to provide a specific recommendation towards reducing the risk that product destined for human consumption is diverted to higher-risk usage such as feed for aquaculture or bait for recreational fishing..

The Aquatic Animals Commission noted that Members’ reservations about references in the Aquatic Code to publications of the International Council for the Exploration of the Seas (ICES) should be largely addressed via the establishment of an Agreement between the OIE and ICES (see item 8.3.).

The Aquatic Animals Commission discussed the provision that appears in several chapters of the Aquatic Code, to the effect that ‘importing countries should consider imposing measures to ensure that imported products are used as intended’ for purposes of risk management. The Aquatic Animals Commission agreed to amend ‘should’ to ‘may wish to’, for consistency with the Terrestrial Code. This change will be applied across all disease chapters in the Aquatic Code dealing with the concept of product use.

2.9.2. Infectious myonecrosis (Chapter 2.3.9.) and White tail disease (Chapter 2.3.11.)

The Aquatic Animals Commission accepted all amendments circulated in the March 2007 Report. Members’ comments submitted by 6 August were taken into consideration and the texts amended as appropriate. Minor changes were made to ensure consistency with the other disease chapters adopted in May 2007. Amendments are shown in the usual manner as double underline and strikeout. Amendments made at this meeting (October 2007) are shown with a coloured background to distinguish them from those made previously.

The amended texts are at Annexes XIII and IX for Members’ comments, with a view to proposing them to the International Committee for adoption at the 76th General Session in May 2008.

2.9.3. Crayfish plague (Chapter 2.3.7.)

For this agenda item, the Aquatic Animals Commission was joined by Dr David Alderman, an OIE expert on crayfish plague. Dr Alderman had been provided with Members’ comments on the draft chapter that had been circulated with the March 2007 report. The Aquatic Animals Commission discussed with Dr Alderman the difficulties in preparing recommendations for trade in species susceptible to this disease because of its different nature compared with other diseases. Dr Alderman undertook to prepare a revised version of the chapter, in consultation with other crayfish plague experts, in time for the March 2008 meeting of the Aquatic Animals Commission.

2.9.4. Infection with Microcytos mackini (Chapter 2.2.5.)

The Aquatic Animals Commission considered a comment from an OIE expert and amended the text accordingly. Minor changes were made to ensure consistency with other disease chapters adopted in May 2007. Amendments made during this meeting (October 2007) are shown in the usual manner as double underline and strikeout. The amended text is at Annex X for Members’ comments, with a view to proposing it to the International Committee for adoption at the 76th General Session in May 2008.

2.9.5. Gyrodactylosis (Chapter 2.1.14.)

The ad hoc Group on Fish Disease Chapters for the Aquatic Code had considered Members’ comments and had proposed appropriate amendments to the text. The Aquatic Code Commission made further amendments at its meeting and the redrafted chapter is at Annex XI for Members’ comments, with a view to proposing it to the International Committee for adoption at the 76th General Session in May 2008.

The Aquatic Animals Commission considered a Member’s comment that Article 2.1.14.12. is irrelevant and invited the Member to justify this comment.

2.9.6. Draft chapters for amphibian diseases

See agenda item 2.13. below.

2.9.7. Harmonisation of disease chapters

To ensure consistency with other disease chapters, minor editorial changes that had been adopted at the 75th General Session in May 2007 will be applied to other relevant disease chapters in the 2008 Aquatic Code.

2.10. Draft appendices on aquatic animal welfare

Community comment

The Community looks forward to the outcome of the Aquatic Animals Commission work on the OIE Guidelines for the Welfare of Life Aquatic Animals. The Community also wishes to present specific drafting comments given in the amended text of the Introduction to the Guidelines.

The Aquatic Animals Commission expressed its gratitude to the Permanent Animal Welfare Working Group and Professor Håstein for their work in developing OIE Guidelines on the Welfare of Live Aquatic Animals. However, the Aquatic Animals Commission remained concerned that the scientific basis for the guidelines on farmed fish had not yet been clearly established. The Aquatic Animals Commission also considered that the guidelines, as drafted, were still too prescriptive in some places.

The Aquatic Animals Commission decided that the Introduction to the OIE Guidelines for the Welfare of Live Aquatic Animals, which was amended on the basis of Members’ comments and the views of the Aquatic Animals Commission, should be distributed to Members’ for comment. In the interim, one or more members of the Aquatic Animals Commission would continue working on the Guidelines.

The amended text of the Introduction to the Guidelines is at Annex XII for Members’ comments, with a view to proposing it to the International Committee for adoption at the 76th General Session in May 2008.

2.11. Antimicrobial resistance in the field of aquatic animals

Dr Tomoko Ishibashi, Deputy Director of the OIE Scientific and Technical Department, joined the Aquatic Animals Commission for this item. Dr Ishibashi provided an update on developments on this file. She explained that the fourth joint FAO/WHO/OIE Meeting on Critically Important Antimicrobials, to be held on 26 November 2007, will be an important forum to discuss the appropriate balance between animal health needs and public health concerns in the use of antimicrobial products. There will also be an associated stakeholder meeting. Dr Ishibashi identified the 15 experts selected to attend the joint meeting, noting that most of these experts are not involved in aquatic animal health. The Aquatic Animals Commission thanked Dr Ishibashi for this update and decided to keep the matter under review.

2.12. Report of the meeting of the ad hoc Group on Aquatic Animal Feeds

Professor Katunguka-Rwakishaya presented the report of the OIE ad hoc Group on Aquatic Animal Feeds, which met in August 2007 to address Members’ comments on the previously circulated draft Guidelines on the Control of Aquatic Animal Health Hazards in Aquatic Animal Feed. The Aquatic Animals Commission thanked Professor Katunguka-Rwakishaya for chairing this Group and commended the report. The report of the ad hoc Group is at Annex XVIII for Members’ information.

The amended Draft Guidelines on the Control of Aquatic Animal Health Hazards in Aquatic Animal Feed are presented at Annex XIII for Members’ comments, with a view to proposing them to the International Committee for adoption at the 76th General Session in May 2008. Amendments made during this meeting (October 2007) are shown in the usual manner as double underline and strikeout, in Annex XIIIa. Because these amendments also show the numerous editorial changes, a clean version is provided in the same Annex as XIIIb, for easier reading.

2.13. Report of the meeting of the ad hoc Group on Amphibian Diseases

Dr Hill presented the report of the OIE ad hoc Group on amphibian diseases, including the assessment of the responses provided by Members’ to the OIE questionnaire on this topic. The ad hoc Group had concluded that the data in the returned questionnaire very significantly underestimated the current international trade in live amphibians and their products and considered it essential to obtain an accurate picture. The ad hoc Group also recommended publication of the data obtained to increase the awareness of Members’ of the potential spread of amphibian diseases with this trade. The Aquatic Animal Commission agreed to this recommendation and asked the ad hoc Group to submit a draft publication to the Aquatic Animal Commission.

The ad hoc Group drafted disease chapters for the Aquatic Code (Chapter 2.4.1. Infection with Batrachochytrium dendrobatidis and Chapter 2.4.2. Infection with ranavirus) which are provided in Annexes V and VI of the report of the ad hoc Group (see full report at Annex XIX for Members’ information). The Aquatic Animal Commission made minor changes to these draft disease chapters, primarily to make them consistent with other chapters in the Aquatic Code. The drafts chapters are at Annexes XIV and XV for Members’ comments, with a view to propose them to the International Committee for adoption at the 76th General Session in May 2008.

Subsequent to its meeting the ad hoc Group had drafted disease cards for these two diseases for the Aquatic Animal Commission’s comment, with a view to providing finalised versions in time for the Aquatic Animal Commission’s March 2008 meeting. The Aquatic Animals Commission was grateful for this initiative and noted that, if these two diseases are listed in 2008, disease chapters for the Aquatic Manual would also need to be prepared as soon as possible.

The Aquatic Animals Commission agreed to maintain the Model Certificates for Amphibians/Amphibian Products in the current format as drafted by the ad hoc Group, pending a review of Aquatic Animal Health Certificates (see item 2.14.).

The Aquatic Commission considered the question raised by the ad hoc Group of the disease risks associated with transport water and international trade in aquatic plants. The Aquatic Animals Commission considered that the disease risks associated with transport water had been adequately covered in Chapter 1.5.1. (Article 1.5.1.5.). International trade in aquatic plants is outside the mandate of the OIE.

The President of the Aquatic Animals Commission commended the work of this ad hoc Group and thanked Dr Hill for chairing the Group.

2.14. Model Veterinary Certificates

The Aquatic Animals Commission noted a progress report from the Terrestrial Commission regarding the ongoing work of the ad hoc Group on Model Veterinary Certificates. The Aquatic Animals Commission confirmed that it would review the Model Aquatic Animal Health Certificates once the terrestrial equivalent has been finalised.

2.15. Guidelines on handling and disposal of carcasses and wastes of aquatic animals

The Aquatic Animals Commission thanked Professor Katunguka-Rwakishaya for reviewing this topic and preparing the draft text, which has been reformatted by the International Trade Department. The revised text is at Annex XVI for Members’ comments, with a view to proposing it to the International Committee for adoption at the 76th General Session in May 2008.

3. Joint meeting with the President of the Terrestrial Animal Health Standards Animals Commission.

3.1. Harmonising and updating the Aquatic Code and the Terrestrial Code

Dr Kahn represented Dr Thiermann, President of the Terrestrial Commission, who was unable to attend the meeting due to travel duty. Dr Bernoth noted the progress made towards harmonisation of the two Codes. She commented that further progress on the Aquatic Code should await the division of the Terrestrial Code into two volumes as this was likely to entail the revision of some horizontal chapters in the Terrestrial Code.

3.2. Performance, Vision and Strategy (PVS) Tool

Dr Bar-Yaacov joined the meeting for this item. She provided the background to the proposal to modify the OIE Tool for the Evaluation of Performance of Veterinary Services (OIE PVS Tool) to address aquatic animal services. Dr Bar-Yaacov mentioned that she attended the July meeting of the ad hoc Group on the Evaluation of Veterinary Services, which has been responsible for the development of the PVS procedures. She advised the Aquatic Animals Commission that there were some general principles to bear in mind when using the OIE PVS Tool to assess aquatic animal health services.

Dr Bernoth thanked Dr Bar-Yaacov for her valuable input on this item. The Aquatic Animals Commission noted that the OIE has received a request for evaluation of aquatic animal health services. The Aquatic Animals Commission considered that the introduction to the OIE PVS Tool should be revised to provide scope for aquatic animals to be included in an evaluation and to identify the legal basis of such evaluation (i.e. Aquatic Code Chapters 1.4.3.). In addition, general principles should be identified and included in the OIE PVS Tool, to guide assessors on the use of the OIE PVS Tool in the context of evaluating an aquatic animal health system.

Dr Kahn indicated that the Central Bureau will revise the introduction to the OIE PVS Tool and provide an appropriate text for the Aquatic Animals Commission to consider at its next meeting. Dr Bar-Yaacov indicated that she would develop a short text on general principles for the Aquatic Animals Commission to consider at its next meeting. Dr Kahn indicated that Dr Bar-Yaacov would be invited to participate in future OIE activities on the PVS procedures, including the next meeting of the ad hoc Group on the Evaluation of Veterinary Services.

4. Joint meeting with the Publications Department

4.1. Dr Pastoret, Head of OIE Publications Department, and Ms Souryi, Deputy Head of OIE Publications Department, joined the Aquatic Animals Commission for an update on progress with the upcoming publication in the OIE Scientific and Technical Review Series on Changing Trends in Managing Aquatic Animal Disease Emergencies. This review is due for publication in April 2008.

5. The role and activities of the OIE in the field of aquatic animal health

Community Comment

Climate change may be an important factor in the occurrence, distribution and severity of aquatic animal diseases. We would encourage the OIE to set up an ad-hoc working group on this specific issue to asses the relevance of climate change to the full range of OIE programs and objectives.

5.1. International meetings

5.1.1. Regional Commission Conferences

Dr Enriquez, Secretary of the AAHSC, reported on his attendance at the Second Meeting of the Inter-American Committee on Aquatic Animal Health which was held in Vancouver (Canada) in June 2007 and which was organized by the OIE Regional Commission for the Americas in collaboration with Canada as host. He reported on the Technical Resolutions adopted by the International Committee regarding aquatic animal health during the last General Session. Dr. Enriquez provided summaries of the latest developments in the Aquatic Code and Aquatic Manual. Some horizontal changes have been made to all the disease chapters of the Aquatic Code to ensure consistency. He also informed the meeting of the decision of the International Committee to include amphibian diseases in the OIE remit.

The Members of the Regional Commission committee will sponsor translation of the Aquatic Manual into Spanish and provide the funds to do so. The OIE Regional Representation for the Americas will also try to provide funding for a Spanish translation, as soon as possible, of the preliminary English version of the Aquatic Animals Commission Reports.

The Aquatic Animals Commission noted the schedule for the upcoming Regional Commission Conferences and agreed the following representation for follow-up presentations on developments in aquatic animal health:

- Regional Commission for the Middle-East (29 October-1 November 2007): Dr Hill, Vice-President of the Aquatic Animals Commission.

- Regional Commission for Asia, the Far East and Oceania (Queenstown, New Zealand, 26-30 November 2007): Dr Bernoth, President of the Aquatic Animals Commission.

5.1.2. Network of Aquaculture Centres in Asia-Pacific

Dr Bernoth will represent the Aquatic Animals Commission at the Sixth Annual General Meeting of NACA Asia Regional Advisory Group on Aquatic Animal Health, 12-14 December 2007, Bangkok, Thailand. She will report on progress and further development of the Aquatic Code and Aquatic Manual and other new initiatives of the Aquatic Animals Commission.

5.1.3. Other International Conferences

Dr Bernoth has been invited to present on the activities of the OIE in the field of aquatic animal health at the 29th World Veterinary Congress, 27-31 July 2008, Vancouver, British Columbia, Canada. Several members of the Aquatic Animals Commission will attend the 7th Symposium on Diseases in Asian Aquaculture, June 22-26, 2008, Chinese Taipei.

5.2. Cooperation with FAO

The OIE Central Bureau has received a request from the FAO Fisheries and Aquaculture Department to collaborate on a one year project in the seven countries covered by the Zambezi river system (Angola, Botswana, Malawi, Mozambique, Namibia, Zambia and Zimbabwe). The project will increase the capacity of the key national government staff (decision makers and technicians) to undertake surveillance and to diagnose the disease, and will provide the necessary information and extension material to better inform the stakeholders of the risks and of the methods for preventing spread and particularly for how to avoid the introduction of the disease into fish farms. The project would also facilitate the elaboration of a regional emergency preparedness and response strategy related to aquatic health management.

The FAO are also looking at the opportunities for organising a training workshop on aquatic animal health and trade in Eastern Europe, in early 2008, as a component of an ongoing FAO Technical Cooperation Programme project in Bosnia and would like the OIE to participate in these activities and technically contribute to the process.

The Aquatic Animals Commission noted this project and workshop and will continue to work with the OIE Central Bureau to support further strengthening of the collaboration between OIE and FAO.

6. Manual of Diagnostic Tests for Aquatic Animals

Community Comment

The Community would like to thank to the OIE AAC the efforts to be carried out to update the chapters for some not listed diseases such as IPN, Piscirickettsiosis or Spawner-isolated mortality. However, Community considers it important that the OIE AAC includes in its working programme the update o the f the BKD chapter as well.

In addition, we would like to remind that the disinfection chapters in the Aquatic Manual must contain references to disinfestation, as most of listed mollusc diseases are infestations.

6.1. Update from the Consultant Editor

For this agenda item, the Aquatic Animals Commission was joined by Dr David Alderman, Consultant Editor of the Aquatic Manual. Dr Alderman briefed the Aquatic Animals Commission on the status of the next version of the Aquatic Manual. Since the previous meeting, he had introduced a section-numbering system into the template for the disease-specific chapters so that it is easier to cross refer to sections within a chapter. The Aquatic Animals Commission reviewed the template, compared it to the template developed by the ad hoc Group on Aquatic Animal Health Surveillance (see item 6.2 below), and inserted a few amendments. The new template will now be sent to all the authors, including authors of chapters that were not updated in the 2006 edition, with the request that they use it to update their chapters. It is hoped to receive all the updated chapters in the first quarter of 2008, so that they can be edited and sent to Members’ for comment shortly after that date. The next edition of the Aquatic Manual is scheduled to be published in June/July 2009.

Since the 6th edition of the Aquatic Manual some diseases have been de-listed from Chapter 1.2.3. of the Aquatic Code and some Reference Laboratories and designated experts are no longer included in the list. The Aquatic Animals Commission is of the view that there is value in updating chapters for infectious pancreatic necrosis, piscirickettsiosis (Piscirickettsia salmonis) and spawner-isolated mortality virus disease in the Aquatic Manual and seeks nominations of experts from Members’ for this purpose.

The current Aquatic Manual chapter on disinfection of aquaculture establishments is divided into three sections: one each for fish, mollusc and crustacean farms. This means that there is some repetition as the principles and some procedures are common to all three groups. Dr Alderman agreed to rearrange the chapter such that it begins with the general principles and procedures followed by specific procedures for fish, molluscs and crustaceans, e.g. fish eggs, crustacean broodstock, etc. Dr Alderman advised the Aquatic Animals Commission that he has made some progress with what is a substantial task and he hoped to provide the Aquatic Animals Commission with a draft chapter by December 2007.

6.2. Report of the OIE ad hoc Group on Aquatic Animal Health Surveillance

Community Comment

The Community would like to contribute to the development of the disease specific surveillance guidelines with its current surveillance schemes to obtain and maintain the freedom status with regard to VHS and INH. These guidelines can be found in Commission Decision 2001/183/EC laying down the sampling plans and diagnostic methods for the detection and confirmation of certain fish diseases. http://eur-lex.europa.eu/pri/en/oj/dat/2001/l_067/l_06720010309en00650076.pdf

Dr Hill presented the second progress report of the OIE ad hoc Group on Aquatic Animal Health Surveillance. The Aquatic Animal Commission reviewed the report and commends the ad hoc Group for the outstanding efforts that have been made in producing the guidelines on surveillance. The Aquatic Animals Commission examined in detail the proposed appendix on aquatic animal health surveillance for the Aquatic Code as well as the proposed guidelines for the Aquatic Manual (revision of chapter 1.1.4) prepared by the ad hoc Group. The Aquatic Animals Commission noted that the Terrestrial Manual does not provide guidelines on animal health surveillance but rather this information is provided in the Terrestrial Code. In line with harmonising terrestrial and aquatic standards, the Aquatic Animals Commission decided to merge the information on surveillance into one set of guidelines to be appended to the Aquatic Code. The draft text is at Annex XVII for Members’ comments, with a view to proposing it to the International Committee for adoption at the 76th General Session in May 2008.

The Aquatic Animals Commission proposed the development of a practical handbook for aquatic animal health surveillance, using the substantial work done by the ad hoc Group as the basis for this publication. They suggested that the ad hoc Group work on this publication at their next meeting. The Central Bureau indicated the possible availability of an intern to assist in the preparation of this publication.

The Aquatic Animals Commission also reviewed the further development by the ad hoc Group of the specific disease chapter template of the Aquatic Manual. The ad hoc Group recommended that the scientific information necessary to develop appropriate surveillance programmes for the individual diseases be formulated and included in the Aquatic Manual chapters. The Aquatic Animals Commission noted the large amount of epidemiological data that would be required to complete the surveillance part of each disease chapter and concluded that this would be a major task and beyond the scope of the Aquatic Manual chapters. Because the guidelines on surveillance are now to be appended to the Aquatic Code (see above), the Aquatic Animals Commission decided to limit the disease chapters in the Aquatic Manual to diagnostic aspects as is the case in the Terrestrial Manual. Disease-specific surveillance chapters would be prepared as appendices to the Aquatic Code as is the case in the Terrestrial Code.

The Aquatic Animals Commission took note of the comments by the ad hoc Group that the development of guidelines for individual disease chapter authors to follow in specifying the surveillance requirements for individual diseases has also become a major task. The Aquatic Animals Commission clarified that those guidelines are no longer required for the authors of the disease chapters in the Aquatic Manual but rather for the individual disease surveillance chapters to be added to the Aquatic Code and encourages the ad hoc Group to develop these taking into account the approach taken in the Terrestrial Code.

7. OIE Reference Laboratories

The Aquatic Animals Commission had received an application for OIE Reference Laboratory status for abalone viral mortality. Because there are certain unresolved scientific issues regarding this disease complex, the Aquatic Animals Commission decided to await the outcome of the forthcoming meeting of the ad hoc Group on Abalone diseases, to which the proposed expert would be invited to participate (see also item 2.2.).

Following the listing of infectious myonecrosis and white tail disease in May 2007, there is now a need for OIE Reference Laboratories for these two diseases. The Aquatic Animals Commission encourages interested countries to submit applications for OIE Reference Laboratory status through the OIE Delegate. The Aquatic Animals Commission also seeks applications for an OIE Reference Laboratory for viral haemorrhagic septicaemia in North America in view of the recent outbreaks of a new form of this disease in this region.

8. Any other business

8.1. Disease cards

The Aquatic Animals Commission acknowledged the comment from Chinese Taipei on the inconsistency between the disease card and the draft disease chapter in the Aquatic Code for white tail disease and will correct the disease card accordingly.

The Aquatic Animals Commission confirmed its proposition from March 2007 to have disease cards only for emerging and recently listed diseases for which there is not yet an Aquatic Manual chapter, and to discontinue the cards for all the other diseases. Cards for infectious myonecrosis and white tail disease, diseases that were adopted for listing at the General Session in May 2007, are thus available on the web. Cards for the proposed diseases of amphibians are being developed.

8.2. Update of the Aquatic Animals Commission web pages

Dr Hill presented the amended web pages and confirmed that all the information, including the disease list and links to national contingency plans and import risk analyses, is up to date.

8.3. Update on proposed OIE agreement with the International Council for the Exploration of the Seas (ICES)

The Aquatic Animals Commission noted a draft letter of agreement between the OIE and International Council for the Exploration of the Seas (ICES). The Aquatic Animals Commission endorsed this agreement.

8.4. Review of the Aquatic Animals Commission work plan for 2007-2008

The Aquatic Animals Commission reviewed its work plan for the remainder of 2007 and 2008. The updated work plan is at Annex XX for Members’ information

9. Date for next meeting

The Aquatic Animals Commission proposed to meet on 3-7 March 2008.

.../Annexes

Annex I

MEETING OF THE OIE

AQUATIC ANIMAL HEALTH STANDARDS COMMISSION

Paris, 1-5 October 2007

__________

Provisional List of participants

MEMBERS OF THE COMMISSION

Dr Eva-Maria Bernoth(President) Office of the Chief Veterinary Officer, Department of Agriculture, Fisheries and Forestry – Australia, GPO Box 858, Canberra ACT 2601 AUSTRALIA Tel.: (61-2) 62.72.43.28Fax: (61-2) 62.73.52.37Email: eva-maria.bernoth@affa.gov.au | Dr. Barry Hill(Vice-President) CEFAS  Weymouth Laboratory Barrack Road, The Nothe Weymouth, Dorset DT4 8UB UNITED KINGDOM Tel.: (44-1305) 20.66.25 Fax: (44-1305) 20.66.01 E-mail: b.j.hill@cefas.co.uk | Dr Ricardo Enriquez(Secretary General) Patología Animal / Ictiopatología Universidad Austral de Chile Casilla 567 - Valdivia CHILE Tel.: (56-63) 22.11.20 Fax: (56-63) 21.89.18 E-mail: renrique@uach.cl |

Dr Franck BertheSenior Scientific OfficerEuropean Food Safety Authority - EFSAAnimal Health and Animal Welfare unit Largo N. Palli 5/A, 43100 Parma ITALY Tel.: + 39 0521 036 870 Fax: + 39 0521 036 766Email: Franck.Berthe@efsa.europa.eu | Prof. Eli Katunguka-Rwakishaya Director School of Graduate Studies Makerere University, P.O. Box 7062, Kampala UGANDA Tel.: (256.41) 53.0983 54.0564 Fax: (256-41) 533809 email: erkatunguka@vetmed.mak.ac.ug mupgs@muspgs.mak.ac.ug | |

OTHER PARTICIPANTS

Dr. David Alderman16 WillowbrookPreston RdWeymouthDorset, DT3 6PZ UNITED KINGDOM Tel.:Phone +44 1305 833737E-mail : d.j.alderman@btinternet.com | Dr Keren Bar-YaacovChief Veterinary OfficerNorwegian Food Safety Authority, Head OfficeDepartment for health and hygieneP.O.Box 383, N-2381 BrumunddalNORWAY Tel.: + 47 23 21 65 40 Fax : + 47 23 21 68 01 E-mail : postmottak@mattilsynet.noKeren.Bar-Yaacov@mattilsynet.no | Prof. Donald V. Lightner (Crustacean disease expert) Aquaculture Pathology Section, Department of Veterinary Science & Microbiology, University of Arizona, Building 90, Room 202, Tucson, AZ 85721 UNITED STATES OF AMERICA Tel.: (1.520) 621.84.14 Fax: (1-520) 621.48.99E-mail: dvl@u.arizona.edu |

Annex I (contd)

OIE HEADQUARTERS

Dr Bernard Vallat Director General OIE 12, rue de Prony 75017 Paris FRANCE Tel.: 33 - (0)1 44 15 18 88 Fax: 33 - (0)1 42 67 09 87 E-mail: oie@oie.int | Dr Sarah Kahn Head International Trade Department OIE E-mail: s.kahn@oie.int | Dr Tomoko Ishibashi Deputy Head Scientific and Technical Department OIE E-mail: t.ishibashi@oie.int |

Dr Paul-Pierre Pastoret Head Publications Department OIE E-mail: pp.pastoret@oie.int | Ms Annie Souyri Deputy Head Publications Department OIE E-mail: a.souyri@oie.int | Ms Sara Linnane Scientific editor Scientific and Technical Department OIEE-mail: s.linnane@oie.int |

Dr Gillian MylreaChargée de mission International Trade Department OIE E-mail: g.mylrea@oie.int | Dr Leopoldo Stuardo Deputy Head International Trade Department OIE E-mail: l.stuardo@oie.int | Dr Francesco Berlingieri Deputy Head Animal Health Information Department OIE E-mail: f.berlingieri@oie.int |

Annex II

MEETING OF THE OIE

AQUATIC ANIMAL HEALTH STANDARDS COMMISSION

Paris, 1-5 October 2007

__________

Adopted Agenda

1. Activities and progress of ad hoc Groups

2. Aquatic Animal Health Code

2.1. Definitions (Chapter 1.1.1.)

2.2. Diseases listed by the OIE (Chapter 1.2.3.)

2.3. Obligations and ethics in international trade (Chapter 1.3.1.)

2.4. Zoning and compartmentalisation (Chapter 1.4.4.)

2.5. Aquatic animal health measures applicable before and at departure (Chapter 1.5.2.)

2.6. Aquatic animal health measures applicable on arrival (Chapter 1.5.5.)

2.7. Risk analysis – Guidelines for import risk analysis (Chapter 1.4.2.)

2.8. Recommendations for transport (Chapter 1.5.1.)

2.9. Disease chapters

2.10. Draft appendices on aquatic animal welfare

2.11. Antimicrobial resistance in the field of aquatic animals

2.12. Report of the meeting of the ad hoc Group on Aquatic Animal Feeds

2.13. Report of the meeting of the ad hoc Group on Amphibian Diseases

2.14. Model veterinary certificates

2.15. Guidelines on handling and disposal of carcasses and wastes of aquatic animals

3. Joint meeting with the President of the Terrestrial Animal Health Standards Commission

3.1. Harmonising and updating the Aquatic Code and the Terrestrial Code

3.2. Performance, Vision and Strategy (PVS) tool

Annex II (contd)

4. Joint meeting with the Publications Department

4.1. OIE Scientific and Technical Review: Issue on managing aquatic animal disease emergencies

5. The role and activities of the OIE in the field of aquatic animal health

5.1. International meetings

5.1.1. Regional Commissions Conferences

5.1.2. Other meetings

5.2. Cooperation with FAO

6. Manual of Diagnostic Tests for Aquatic Animals

6.1. Update from the Consultant Editor

6.2. Report of the Ad hoc Group on Surveillance: Revision of chapters for the Aquatic Code and Manual

7. OIE Reference Laboratories

8. Any other business

8.1. Disease cards

8.2. Update of the Commission’s web pages

8.3. Update on proposed OIE agreement with the International Council for the Exploration of the Seas (ICES)

8.4. Review of the Aquatic Animals Commission’s work plan for 2007-2008

9. Date of the next meeting

_______________

Annex III

CHAPTER 1.1.1.

DEFINITIONS

Article 1.1.1.1.

Community comment

The Community has strong reservations with the proposed definitions, especially with the proposed definition of infestation. If this definition is to be changed the definition of susceptible species, infection and disease should be as well subjected to discussion.

In addition, in this report, the term "vector" is used without a clear definition of what is meant by vector. A definition of vector is needed. The Community would propose the following definition:

Vector: means a species that is not susceptible to a disease but which is capable of spreading infection by conveying pathogens from one host to another.

Aquatic animals

means all life stages (including eggs and gametes) of fish, molluscs, and crustaceans, and amphibians originating from aquaculture establishments or removed from the wild, for farming purposes, for release into the aquatic environment or for human consumption.

Area of direct transit

means a special area established in a transit country approved by the relevant Competent Authority where aquatic animals stay for a very short time, and where water changes may be made, before further transport to their final destination when passing through the transit territory.

Bias

A tendency of an estimate to differ in a non-random fashion from the true value of a population parameter.

Case definition

A case definition is a set of criteria used to distinguish a case animal or epidemiological unit from a non-case.

Infestation

means the presence in sufficient numbers of a multiplying of a notifiable parasitic, or commensal, agent on or in a host a host so as to cause damage or disease.

Community comment: Proposed definition for "Infestation".

The proposed definition supposes a major change compared to the current one as it removes the reference to the multiplication of the parasite. We would like that the OIE provides a clear explanation of the rationale of such an amendment. Otherwise, the Community would not accept the proposed new definition.

In addition, such major amendment cannot only be done in the definition of infestation. If the explanation to be provided is satisfactory, the amendment should be done in the definition of infection.

Moreover, if this definition is accepted in the General Session 2008, the definition of susceptible species and the list of susceptible species to each listed disease would be challenged.

The Community would propose the following definition for infestation:

"Means the presence of a multiplying parasitic agent on or in aquatic animals"

Offal

means visceral organs, cut-offs, condemned raw material, organs, etc. of aquatic animals.

Outbreak of disease

An outbreak is a substantial increase in the means an occurrence of disease in an aquatic animal above the expected level at a given time in a given population.

Community comment: proposed definition for "outbreak of disease"

We would retain our previous comment: in our view this is not the definition of an outbreak. This is the definition of an epidemic. Please, consider the definition laid down in the Terrestrial Code for outbreak of disease "occurrence of one or more cases of a disease in an epidemiological unit"

Probability sampling

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

Sensitivity

the proportion of true positive tests given in a diagnostic test, i.e. the number of true positive results divided by the number of true positive and false negative results.

Specificity

the probability that absence of infection will be correctly identified by a diagnostic test, i.e. the number of true negative results divided by the number of true negative and false positive results.

Annex III (contd)

Study population

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

- - - - - - - - - - - - - -

text deleted

Annex IV

CHAPTER 1.2.3.

DISEASES LISTED BY THE OIE

Community comment

The Community agrees with the proposed amendments

Preamble: The following diseases are listed by the OIE according to the criteria for listing an aquatic animal disease (see Article 1.2.2.1.) or criteria for listing an emerging aquatic animal disease (see Article 1.2.2.2.).

Article 1.2.3.1.

The following diseases of fish are listed by the OIE:

- Epizootic haematopoietic necrosis

- Infectious haematopoietic necrosis

- Spring viraemia of carp

- Viral haemorrhagic septicaemia

- Infectious salmon anaemia

- Epizootic ulcerative syndrome

- Gyrodactylosis (Gyrodactylus salaris)

- Red sea bream iridoviral disease

- Koi herpesvirus disease.

Article 1.2.3.2.

The following diseases of molluscs are listed by the OIE:

- Infection with Bonamia ostreae

- Infection with Bonamia exitiosa

- Infection with Marteilia refringens

- Infection with Perkinsus marinus

- Infection with Perkinsus olseni

- Infection with Xenohaliotis californiensis

- Abalone viral mortality 1.

Article 1.2.3.3.

The following diseases of crustaceans are listed by the OIE:

- Taura syndrome

- White spot disease

- Yellowhead disease

- Tetrahedral baculovirosis (Baculovirus penaei)

- Spherical baculovirosis (Penaeus monodon-type baculovirus)

- Infectious hypodermal and haematopoietic necrosis

- Crayfish plague (Aphanomyces astaci)

- Necrotising hepatopancreatitis 2

- Infectious myonecrosis

- White tail disease 1

- Hepatopancreatic parvovirus disease 2

- Mourilyan virus disease 2.

Article 1.2.3.4.

The following diseases of amphibians are listed by the OIE:

- Infection with Bactrachochytrium dendrobatidis

- Infection with ranavirus

(...PICT...)

(...PICT...)

1. Listed according to Article 1.2.2.2.

2. Listing of this disease is under study.

- - - - - - - - - - - - - -

text deleted

Annex V

(...PICT...)

CHAPTER 1.3.1.

GENERAL OBLIGATIONS

Community comment

The Community agrees with the proposed amendments but would like that the OIE AAC takes into account its comments.

Article 1.3.1.1.

International trade in aquatic animals and aquatic animal products depends on a combination of health factors that should be taken into account to ensure unimpeded trade, without incurring unacceptable risks to human and aquatic animal health. As a general principle, international trade in aquatic animals and their products from populations known to be infected with a listed disease and considered to be capable of transmitting the disease should only be done with the prior agreement of the importing and exporting countries.

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

These requirements should be included in the model international aquatic animal health certificates approved by the OIE, which form Part 4. of the Aquatic Code.

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

When Members of, or representatives acting on behalf of, a Competent Authority wish to visit another country for matters of professional interest to the Competent Authority of the other country, the latter should be informed.

Article 1.3.1.2.

Community comment

For the sake of harmonisation with the Terrestrial Code, it would be necessary to add the following paragraph as point 4 of this article:

"The international veterinary certificate should not include requirements for disease agents or diseases which are not OIE listed, unless the importing country has identified the disease agent as presenting a significant risk for that country, after conducting a scientifically based import risk analysis according to the guidelines in Section 1.4"

Responsibilities of the importing country

1. The import requirements included in the international aquatic animal health certificate should assure that commodities introduced into the importing country comply with the national level of protection. Importing countries should restrict their requirements to those justified for such level of protection. If these are more strict than the OIE standards, guidelines and recommendations, then they should be based on an import risk analysis.

2. The international aquatic animal health certificate should not include requirements for the exclusion of pathogens or aquatic animal diseases that are present within the territory of the importing country and are not subject to any official control programme. The requirements applying to pathogens or diseases subject to official control programmes in a country, or zone should not provide a higher level of protection on imports than that provided for the same pathogens or diseases by the measures applied within that country, or zone.

Annex V (contd)

3. The transmission by the Competent Authority or Veterinary Administration of certificates or the communication of import requirements to persons other than the Competent Authority or Veterinary Administration of another country necessitates that copies of these documents be also sent to the Competent Authority or Veterinary Administration.

This important procedure avoids delays and difficulties that may arise between traders and Competent Authorities or Veterinary Administrations when the authenticity of the certificates or permits is not established.

This information is usually the responsibility of Veterinary Administrations or other Competent Authorities of the exporting country. However, it can be the responsibility of Veterinary Authorities or other Competent Authorities at the place of origin of the aquatic animals, if different from the exporting country, when it is agreed that the issue of certificates does not require the approval of the Veterinary Administrations or other Competent Authorities.

Article 1.3.1.3.

Community comment

We do not understand the rationale to remove paragraph 1 f). We consider that the information on the nature of biological test and vaccines used in a country is a key element when assessing the epidemiological situation of the exporting country.

Responsibilities of the exporting country

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

a) information on the aquatic animal health situation and national aquatic animal health information systems to determine whether that country is free or has zones or compartments that are free from OIE-listed diseases referred to in this Aquatic Code including the regulations and procedures in force to maintain its free status;

b) regular and prompt information on the occurrence of transmissible listed diseases referred to in this Aquatic Code;

c) for diseases not listed referred to in this Aquatic Code, if there are new findings that are of potential epidemiological significance to other countries;

d) details of the country's ability to apply measures to control and prevent OIE-listed diseases referred to in this Aquatic Code;

e) information on the structure of the Competent Authority and the authority that they exercise;

f) technical information, particularly on biological tests and vaccines applied in all or part of the national territory;

g) identification of the country or location of harvest or production of the product being exported.

2. Competent Authorities of exporting countries should:

a) have official procedures for the authorisation of certifying officials, defining their functions and duties as well as conditions covering possible suspension and termination of their appointment;

b) ensure that the relevant instructions and training are provided to certifying officials;

c) monitor the activities of the certifying officials to verify their integrity and impartiality.

Annex V (contd)

The Head of the Competent Authority of the exporting country is ultimately accountable for the certifying official used in international trade.

Article 1.3.1.4.

Community comment

As the incubation period of the listed diseases is not described in the Aquatic Code, we would kindly suggest to the OIE either:

-Either to define the recognised incubation period for each listed disease

-or to slightly modify the wording in the 2nd paragraph, replacing the reference to recognised incubation period of the disease by "reasonable period"

Finally, in our opinion the last sentence of this article is out of the scope of the OIE AAC remit. We would propose the deletion of that sentence. Therefore last paragraph would read:

In case of suspicion, on reasonable grounds, that an official certificate may be fraudulent, the Competent Authority of the importing country and exporting country should conduct an investigation. Consideration should also be given to notifying any third country(ies) that may have been implicated. All associated consignments should be kept under official control, pending the outcome of the investigation. The Competent Authorities of all countries involved should fully cooperate with the investigation.

Responsibilities in case of an incident occurring after importation

International trade involves a continuing ethical responsibility. Therefore, if within a reasonable period the recognised infective periods of the various diseases subsequent to an export taking place, the Competent Authority becomes aware of the appearance or reappearance of a disease that has been specifically included in the international aquatic animal health certificate or other disease of potential epidemiological importance to the importing country there is an obligation for the Authority to notify the importing country, so that the imported aquatic animals may be inspected or tested and appropriate action be taken to limit the spread of the disease should it have been inadvertently introduced.

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

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

- - - - - - - - - - - - - -

text deleted

Annex VI

CHAPTER 1.4.2.

GUIDELINES FOR IMPORT RISK ANALYSIS

Community comment

The Community agrees with the proposed amendments

Article 1.4.2.1.

Introduction

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

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

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

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

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

(...PICT...)

Article 1.4.2.2.

Hazard identification

Hazard identification involves identifying the pathogenic agents that could potentially produce adverse consequences associated with the importation of a commodity.

Annex VI (contd)

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

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

The evaluation of the Competent Authorities, surveillance and control programmes, and zoning and regionalisation systems are important inputs for assessing the likelihood of hazards being present in the aquatic animalpopulation of the exporting country.

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

Article 1.4.2.3.

Principles of risk assessment

1. Risk assessment should be flexible in order to deal with the complexity of real-life situations. No single method is applicable in all cases. Risk assessment must be able to accommodate the variety of animal commodities, the multiple hazards that may be identified with an importation and the specificity of each disease, detection and surveillance systems, exposure scenarios and types and amounts of data and information.

2. Both qualitative and quantitative risk assessment methods are valid. Although quantitative analysis is recognised to provide deeper insights into a particular problem, qualitative methods may be more relevant when available data are limited as is often the case with aquatic species.

3. The risk assessment should be based on the best available information that is in accord with current scientific thinking. The assessment should be well documented and supported with references to the scientific literature and other sources, including expert opinion.

4. Consistency in risk assessment methods should be encouraged and transparency is essential in order to ensure fairness and rationality, consistency in decision making and ease of understanding by all the interested parties.

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

6. Risk increases with increasing volume of commodity imported.

7. The risk assessment should be amenable to updating when additional information becomes available.Annex VI (contd)

Article 1.4.2.4.

Risk assessment steps

1. Release assessment

Release assessment consists of describing the biological pathway(s) necessary for an importation activity to 'release' (that is, introduce) a hazard into a particular environment, and estimating the likelihood of that complete process occurring. The release assessment describes the likelihood of the 'release' of each of the hazards under each specified set of conditions with respect to amounts and timing, and how these might change as a result of various actions, events or measures. Examples of the kind of inputs that may be required in the release assessment are:

a) Biological factors

– Species, strain or genotype, and age of aquatic animal

– Strain of agent

– Tissue sites of infection and/or contamination

– Vaccination, testing, treatment and quarantine.

b) Country factors

– Incidence/prevalence

– Evaluation of Competent Authorities, surveillance and control programmes, and zoning systems of the exporting country.

c) Commodity factors

– Whether the commodity is alive or dead

– Quantity of commodity to be imported

– Ease of contamination

– Effect of the various processing methods on the pathogenic agent in the commodity

– Effect of storage and transport on the pathogenic agent in the commodity.

If the release assessment demonstrates no significant risk, the risk assessment does not need continue.

2. Exposure assessment

Exposure assessment consists of describing the biological pathway(s) necessary for exposure of humans and aquatic and terrestrial animals in the importing country to the hazards and estimating the likelihood of these exposure(s) occurring, and of the spread or establishment of the hazard.

Annex VI (contd)

The likelihood of exposure to the hazards is estimated for specified exposure conditions with respect to amounts, timing, frequency, duration of exposure, routes of exposure, and the number, species and other characteristics of the human, aquatic animal or terrestrial animal populations exposed. Examples of the kind of inputs that may be required in the exposure assessment are:

a) Biological factors

– Presence of potential vectors or intermediate hosts

– Genotype of host

– Properties of the agent (e.g. virulence, pathogenicity and survival parameters).

b) Country factors

– Aquatic animal demographics (e.g. presence of known susceptible and carrier species, distribution)

– Human and terrestrial animal demographics (e.g. possibility of scavengers, presence of piscivorous birds)

– Customs and cultural practices

– Geographical and environmental characteristics (e.g. hydrographic data, temperature ranges, water courses).

c) Commodity factors

– Whether the commodity is alive or dead

– Quantity of commodity to be imported

– Intended use of the imported aquatic animals or products (e.g. domestic consumption, restocking, incorporation in or use as aquaculture feed or bait)

– Waste disposal practices.

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

3. Consequence assessment

Consequence assessment consists of identifying the potential biological, environmental and economic consequences. A causal process must exist by which exposures to a hazard result in adverse health, environmental or socio-economic consequences. Examples of consequences include:

a) Direct consequences

– Aquatic animal infection, disease, production losses and facility closures

– Adverse, and possibly irreversible, consequences to the environment

– Public health consequences. Annex VI (contd)

b) Indirect consequences

– Surveillance and control costs

– Compensation costs

– Potential trade losses

– Adverse consumer reaction.

4. Risk estimation

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

For a quantitative assessment, the final outputs may include:

– The various populations of aquatic animals and/or estimated numbers of aquaculture establishments or people likely to experience health impacts of various degrees of severity over time

– Probability distributions, confidence intervals, and other means for expressing the uncertainties in these estimates

– Portrayal of the variance of all model inputs

– A sensitivity analysis to rank the inputs as to their contribution to the variance of the risk estimation output

– Analysis of the dependence and correlation between model inputs.

Article 1.4.2.5.

Principles of risk management

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

2. The international standards of the OIE are the preferred choice of sanitary measures for risk management. The application of these sanitary measures should be in accordance with the intentions of the standards or other recommendations of the SPS Agreement.

Article 1.4.2.6.

Risk management components

1. Risk evaluation - the process of comparing the risk estimated in the risk assessment with the Member’s appropriate level of protection.

Annex VI (contd)

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

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

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

Article 1.4.2.7.

Principles of risk communication

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

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

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

4. The principal participants in risk communication include the authorities in the exporting country and other stakeholders such as domestic aquaculturists, recreational and commercial fishermen, conservation and wildlife groups, consumer groups, and domestic and foreign industry groups.

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

(...PICT...)

(...PICT...)

6. Peer review of risk analyses is an essential component of risk communication for obtaining a scientific critique aimed at ensuring that the data, information, methods and assumptions are the best available.

- - - - - - - - - - - - - -

text deleted

Annex VII

CHAPTER 1.5.1.

RECOMMENDATIONS FOR TRANSPORT

Community comment

The Community agrees with the proposed amendments.

However, we would encourage the AAC to draft a specific chapter addressing the specific characteristics of the transport by land.

Finally, the Community reiterates its previous comment:

There are some references in this chapter to welfare. This chapter addresses the transport of aquatic animals including some invertebrates. Is it the intention of of the OIE AAC to draft guidelines on invertebrates' welfare? In our opinion, the title and scope of this appendix should be clarified.

Article 1.5.1.1.

Community comment

This chapter is on "Recommendations for transport". They may be used as a valuable reference when implementing measures related to transport. However, they cannot be made compulsory in all countries. We would propose to remove point 1 of this article or to replace it by the following:

1 These arrangements should be used as guidelines when member countries introduce measures to control the aquatic animal health risks related to the transport of these aquatic animals.

General arrangements

1. These arrangements should be compulsory in all countries either by legislative or regulatory texts and methods of application should be described in a manual available to all concerned.

2. Vehicles (or containers) used for the transport of aquatic animals shall be designed, constructed and fitted in such a way as to withstand the weight of the aquatic animals and water and to ensure their safety and welfare during transportation. Vehicles shall be thoroughly cleansed and disinfected before use according to the guidelines given in the Aquatic Code.

3. Vehicles (or containers) in which aquatic animals are confined during transport by sea or by air shall be secured to maintain optimal conditions for the aquatic animals during transport, and to allow easy access by the attendant.

Article 1.5.1.2.

Particular arrangements for containers

1. The construction of containers intended for transportation of aquatic animals shall be such that the accidental release of water, etc., is prevented during transport.

2. In the case of the transportation of aquatic animals, provision shall be made to enable preliminary observation of the contents of containers.

3. Containers in transit in which there are aquatic animal products shall not be opened unless the Competent Authorities of the transit country consider it necessary. If this is the case, containers shall be subject to precautions to prevent contamination.

4. Containers shall be loaded only with one kind of product or, at least, with products not susceptible to contamination by one another.

5. It rests with each country to decide on the facilities it requires for the transport and importation of aquatic animals and aquatic animal products in containers.

Article 1.5.1.3.

Particular arrangements for the transport of aquatic animals by air

1. The stocking densities for the transport of aquatic animals in containers should be determined by taking the following into consideration when transporting by air:

a) the total volume of available space for each type of aquatic animal;

b) the oxygenation capacity available to supply the containers while on the ground and during all stages of the flight.

Annex VII (contd)

With regard to fish, molluscs and crustaceans, the space reserved for each aquatic animal species in containers that have been fitted for the separate transportation of several aquatic animals or for the transportation of groups of aquatic animals should comply with acceptable densities specified for the species in question.

2. The OIE approved International Air Transport Association (IATA) Regulations for live animals may be adopted if they do not conflict with national legislative arrangements. (Copies of these Regulations are obtainable from the International Air Transport Association, 800 Place Victoria, P.O. Box 113, Montreal, Quebec H4Z 1M1, Canada.)

Article 1.5.1.4.

Disinfection and other sanitary measures

1. Disinfection and all zoo-sanitary work should be carried out in order to:

a) avoid all unjustified inconvenience and to prevent damage or injury to the health of people and aquatic animals;

b) avoid damage to the structure of the vehicle or its appliances;

c) prevent, as far as possible, any damage to aquatic animal products.

2. On request, the Competent Authority shall issue the transporters with a certificate indicating the measures that have been applied to all vehicles, the parts of the vehicle that have been treated, the methods used and the reasons that led to the application of the measures.

In the case of aircraft, the certificate may be replaced, on request, by an entry in the General Declaration of the aircraft.

3. Likewise, the Competent Authority shall issue on request:

a) a certificate showing the date of arrival and departure of the aquatic animals;

b) a certificate to the shipper or exporter, the consignee and transporter or their representatives, indicating the measures applied.

Article 1.5.1.5.

Treatment of transportation water

Water to be used for transportation of aquatic animals should be appropriately treated after transport and/or before discharge in order to minimise the risk of transferring pathogens. The specific recommendations are provided in the chapter of the Aquatic Code on disinfection.

During transportation of aquatic animals, the transporter should not be permitted to evacuate and replace the water in the transport tanks except on specifically designated sites in the national territory. The waste and rinsing water should not be emptied into a drainage system that is directly connected to an aquatic environment where aquatic animals are present. The water from the tanks should therefore either be disinfected by a recognised process (for example, 50 mg iodine or chlorine/litre for one hour), or sprayed over land that does not directly drain into waters containing aquatic animals. Each country shall designate the sites in their national territories where these operations can be carried out.

This Article does not apply to treatment of transport water for transport by sea.

Article 1.5.1.6.

Discharge of infected material

The Competent Authority shall take all practical measures to prevent the discharge of any untreated infective material, including transport water, into internal or territorial waters.

This Article does not apply to transport of aquatic animals by sea.

Article 1.5.1.7.

Particular arrangements for the transport of aquatic animals by well boat

A well boat is boat with integrated tanks to carry live fish in sea water that may operate with open valves to allow exchange of sea water. Therefore, well boats can present a biosecurity risk if the fish being carried are infected. Well boats are inherently difficult to disinfect.

1. Only healthy fish showing no clinical signs of disease on the day of loading should be transported. The well boat must have the capability of full containment of fish during its operation if so required. The stocking densities should be determined by taking both the total volume of available space for each species of fish and the oxygenation/aeration capacity available to supply the fish during all stages of transport into consideration.

2. In exceptional circumstances fish may be transported by well boat from an infected site if this is part of a disease response plan agreed to by the Competent Authority.

3. Provision shall be made to enable preliminary observation of the contents in the well, and monitoring equipment should be available where appropriate.

4. Access by farm staff to the vessel and from the vessel to the farm cages, including the equipment, should be restricted.

5. Well boats shall be loaded with only one type of fish at a time.

6. Well boats may operate with open valves except in designated areas in proximity to aquaculture establishments or areas with protected wild populations. The Competent Authority should designate the areas based upon a risk assessment.

7. Multiple deliveries of fish during the same trip should be avoided. Where unavoidable the order of deliveries should be made to the youngest year class of fish first, taking into account health status. Deliveries should be made to sites of a higher health status first, to a single aquaculture establishment, or establishments of the same health status.

8. In the event of mortality occurring during transport, a contingency plan capable of dealing with full containment and disposal of dead fish, via an approved disposal method, should be available. This plan should be prepared according to the Guidelines on handling and disposal of carcasses and wastes of aquatic animals [in preparation].

9. Well boats should not operate in adverse inclement weather conditions that may force the operation to divert from the agreed route and schedule of transport.

Annex VII (contd)

10. The well boat should be cleaned and where required disinfected to an acceptable standard before re-use. The level of disinfection should be proportional to the risk. Well boats should maintain a disinfection checklist which should be kept with the ship’s log and should be open to audit. It is essential to ensure that all fish are removed from the system before cleaning. All organic matter should be removed through the process of cleaning before disinfection commences. The general principles and specific recommendations as outlined in the Aquatic Manual should be consulted for guidance.

11. When travelling between areas and zones of different health levels, cleaning and if required disinfection procedures should be followed and implemented to a standard approved by the Competent Authority.

- - - - - - - - - - - - - -

text deleted

Annex VIII

CHAPTER 2.3.9.

INFECTIOUS MYONECROSIS

Community comment

The Community agrees with the proposed amendments.

However, we would like that the OIE takes the following comments into account.

Article 2.3.9.1.

For the purposes of the Aquatic Code, infectious myonecrosis (IMN) means infection with infectious myonecrosis virus (IMNV). This virus is similar to members of the family Totiviridae.

Methods for conducting surveillance and diagnosis of IMN are provided in the Aquatic Manual.

Article 2.3.9.2.

Community comment

Two separate lists of susceptible species, one in the Code (susceptible species) and one in the Manual (other susceptible species) is misleading, as they create, in fact, two categories of susceptible species.

For the sake of clarity, we would kindly suggest to the OIE to include all susceptible species to this specific infection in this article.

Scope

The recommendations in this Chapter apply to: Pacific white shrimp (Penaeus vannamei). These recommendations also apply to any other susceptible species referred to in the Aquatic Manual when traded internationally.

For the purposes of this Chapter, the terms shrimp and prawn are used interchangeably.

Article 2.3.9.3.

Community comment

Litra b) should also cover dead animals intended for human consumption since there are other risk mitigation measures included in this provision namely: its intended use for human consumption, packed for direct retail trade, which implies that the likelihood of getting in contact with natural waters is very low, and finally that they will not be intended for further processing, avoiding the possible risk of spreading the disease through the effluents of the processing plants.

Before introducing the concept of vector, as it is mentioned in point 3 it is completely necessary to define what Member Countries should understand with this term.

Commodities

1. When authorising importation or transit of the following commodities, the Competent Authorities should not require any IMN related conditions, regardless of the IMN status of the exporting country, zone or compartment.

a) For the species referred to in Article 2.3.9.2. intended being used for any purpose:

i) commodities treated in a manner that inactivates the disease agent e.g. boiled, canned or pasteurised products and ready to eat meals; and crustacean oil and crustacean meal intended for use in animal feeds commercially sterile canned products;

ii) boiled products (e.g. boiled whole shrimp or tails, lobsters, crabs);

iii) chemically extracted chitin;

iv) crustacean meals or by-products made non-infectious by heating or drying (e.g. flame dried or sun dried);

iiiv) crustacean products made non-infectious through processing as dry feeds (e.g. pelleted or extruded feeds);

ivi) biological samples preserved for diagnostic applications in such a manner as to inactivate the disease agent IMNV (e.g. formalin or alcohol preserved samples).

b) The following products destined for human consumption from species referred to in Article 2.3.9.2. which have been prepared and packaged for direct retail trade in such a way as to minimise the likelihood of alternative uses:

Annex VIII (contd)

i) chemically preserved products (e.g. salted, pickled, marinated, pastes, etc.);.

ii) products that have been heat treated or dried (e.g. ready prepared meals) in a manner to ensure the inactivation of the pathogen.

For the commodities listed in point 1b), Members should may wish to consider introducing internal measures to prevent the commodity being used for any purpose other than for human consumption.

2. When authorising the importation or transit of the commodities of a species referred to in Article 2.3.9.2., other than those listed in point 1 of Article 2.3.9.3., the Competent Authorities should require the conditions prescribed in Articles 2.3.9.7. to 2.3.9.11. relevant to the IMN status of the exporting country, zone or compartment.

3. When considering the importation/transit from an exporting country, zone or compartment not declared free of IMN of any other commodity of a species not covered in Article 2.3.9.2. but which could reasonably be expected to be a potential IMNV carrier vector, the Competent Authorities should conduct a risk analysis in accordance with the recommendations in the Aquatic Code of the risk of introduction, establishment and spread of IMNV, and the potential consequences, associated with the importation of the commodity prior to a decision. The exporting country should be informed of the outcome of this assessment.

Article 2.3.9.4.

Infectious myonecrosis free country

A country may make a self-declaration of freedom from IMN if it meets the conditions in points 1, 2, 3 or 4 below.

If a country shares a zone with one or more other countries, it can only make a self-declaration of freedom from IMN if all the areas covered by the shared water are declared IMN free countries or zones (see Article 2.3.9.5.).

1. A country where none of the susceptible species referred to in Article 2.3.9.2. is present may make a self-declaration of freedom from IMN when basic biosecurity conditions have been continuously met in the country for at least the past 2 years.

OR

2. A country where the susceptible species referred to in Article 2.3.9.2. are present but there has never been no any observed occurrence of the disease for at least the past 10 years despite conditions that are conducive to its clinical expression, as described in Chapter X.X.X. of the Aquatic Manual, may make a self-declaration of freedom from IMN when basic biosecurity conditions have been continuously met in the country for at least the past 2 years.

OR

3. A country where the last observed occurrence of the disease was within the past 10 years, or where the infection status prior to targeted surveillance was unknown, for example (e.g. because of the absence of conditions conducive to its clinical expression, as described in Chapter X.X.X. of the Aquatic Manual), may make a self-declaration of freedom from IMN when:

a) basic biosecurity conditions have been continuously met for at least the past 2 years; and

b) targeted surveillance, as described in Chapters 1.1.4. and X.X.X. of the Aquatic Manual, has been in place for at least the last 2 years without detection of IMNV.

OR

4. A country that has previously made a self-declaration of freedom from IMN but in which the disease is subsequently detected may not make a self-declaration of freedom from IMN again until when the following conditions have been met:

a) on detection of the disease, the affected area was declared an infected zone and a buffer zone was established; and

b) infected populations have been destroyed or removed from the infected zone by means that minimise the risk of further spread of the disease, and the appropriate disinfection procedures (see Aquatic Manual) have been completed; and

c) targeted surveillance, as described in Chapters 1.1.4. and X.X.X. of the Aquatic Manual, has been in place for at least the past 2 years without detection of IMNV; and

d) previously existing basic biosecurity conditions have been reviewed and modified as necessary and have continuously been in place for at least the past 2 years.

In the meantime, part of the non-affected area may be declared a free zone provided that they such part meets the conditions in point 3 of Article 2.3.9.5.

Article 2.3.9.5.

Infectious myonecrosis free zone or free compartment

Community comment

The Community would suggest to the OIE to reconsider its position as regards the issue of defining and re-establishing (after a breakdown) the disease free status of a compartment.

We would argue that for certain compartments, formed by a single establishment, disease free status could be regained if aquatic animal population is removed and disposed off, the establishment is properly disinfected and, where appropriate fallowed, and finally restocked with aquatic animals from a certified free source.

The Community would suggest including a new point 5 in this article that would read:

" a compartment previously declared free from infectious myonecrosis but in which the disease is detected may not be declared free from that disease until the following conditions have been met:

a) the requirements in point 4, or

b) in the case that the compartment is formed by one single farm and it is supplied by water from a spring, borehole or other safe supply independent of the heath status of the surrounding waters and it is equipped with a barrier that prevents the migration of aquatic animals of susceptible species into the compartments or its water supply:

i) infected populations have been safely destroyed or removed from the infected compartment by means that minimise the risk of further spread of the disease, and appropriate disinfection procedures have been completed and followed, when necessary, by fallowing

ii) the compartment is repopulated with aquatic animals from a certified free population.

A zone or compartment within the territory of one or more countries not declared free from IMN may be declared free by the Competent Authority(ies) of the country(ies) concerned if the zone or compartment meets the conditions referred to in points 1, 2, 3 or 4 below.

If a zone or compartment extends over more than one country, it can only be declared an IMN free zone or compartment if all the relevant Competent Authorities confirm that the conditions have been met.

1. A zone or compartment where none of the susceptible species referred to in Article 2.3.9.2. is present may be declared free from IMN when basic biosecurity conditions have been continuously met in the zone or compartment for at least the past 2 years.

OR

2. A zone or compartment where the susceptible species referred to in Article 2.3.9.2. are present but in which there has not been any observed occurrence of the disease for at least the past 10 years despite conditions that are conducive to its clinical expression, as described in Chapter X.X.X. of the Aquatic Manual, may be declared free from IMN when basic biosecurity conditions have been continuously met in the zone or compartment for at least the past 2 years.

OR

3. A zone or compartment where the last observed occurrence of the disease was within the past 10 years, or where the infection status prior to targeted surveillance was unknown, for example because of the absence of conditions conducive to its clinical expression, as described in Chapter X.X.X. of the Aquatic Manual), may be declared free from IMN when:

Annex VIII (contd)

a) basic biosecurity conditions have been continuously met for at least the past 2 years; and

b) targeted surveillance, as described in Chapters 1.1.4. and X.X.X. of the Aquatic Manual, has been in place, through the zone or compartment, for at least the past 2 years without detection of IMNV.

OR

4. A zone previously declared free from IMN but in which the disease is subsequently detected may not be declared free from IMN again until when the following conditions have been met:

a) on detection of the disease, the affected area was declared an infected zone and a buffer zone was established; and

b) infected populations have been destroyed or removed from the infected zone by means that minimise the risk of further spread of the disease, and the appropriate disinfection procedures (see Aquatic Manual) have been completed; and

c) targeted surveillance, as described in Chapters 1.1.4. and X.X.X. of the Aquatic Manual, has been in place for at least the past 2 years without detection of IMNV; and

d) previously existing basic biosecurity conditions have been reviewed and modified as necessary and have continuously been in place for at least the past 2 years.

Article 2.3.9.6.

Maintenance of free status

A country, zone or compartment that is declared free from IMN following the provisions of points 1 or 2 of Articles 2.3.9.4. or 2.3.9.5. (as relevant) may maintain its status as IMN free provided that basic biosecurity conditions are continuously maintained.

A country, zone or compartment that is declared free from IMN following the provisions of point 3 of Articles 2.3.9.4. or 2.3.9.5. (as relevant) may discontinue targeted surveillance and maintain its status as IMN free provided that conditions that are conducive to clinical expression of IMN, as described in Chapter X.X.X. of the Aquatic Manual, exist, and basic biosecurity conditions are continuously maintained.

However, for declared free zones or compartments in infected countries and in all cases where conditions are not conducive to clinical expression of IMN, targeted surveillance needs to be continued at a level determined by the Competent Authority on the basis of the likelihood of infection.

Article 2.3.9.7.

Importation of live aquatic animals from a country, zone or compartment declared free from infectious myonecrosis

When importing live aquat