284. The activities of the Biological Standards Commission, which met twice, from 12 to 14 September 2012 and from 20 to 22 February 2013, were presented by Prof. Vincenzo Caporale, President of the Commission (Docs 81 SG/12/CS2 A and B). He thanked the Members of the Commission: Dr Chen Hualan, Vice-President, Dr Rodolfo Rivero, Vice- President, Dr Beverly Schmitt, Dr Paul Townsend and Dr Peter Daniels. He expressed appreciation for the contributions by the other regular participant, Prof. Steven Edwards, Consultant Editor, as well as specialist contributions by OIE experts from Reference Laboratories and Collaborating Centres, and others. Staff at the OIE Headquarters, especially the Scientific and Technical Department, have been unstinting in their support. 285. OIE Reference Centres
The Commission recommended acceptance of the following new applications for OIE Reference Centre status:
– Quality Control of Veterinary Vaccines: African Union Pan African Veterinary Vaccine Centre (AU-PANVAC), Debre-Zeit, ETHIOPIA.
– Swine streptococcosis: Nanjing Agricultural University (NAU), Branch of Swine Streptococcosis Diagnostic Laboratory (BSSDL), Nanjing, Jiangsu Province, CHINA (PEOPLE’S REP. OF).
– Ovine theileriosis: Lanzhou Veterinary Research Institute, Chinese Academy of Agricultural Sciences (CAAS), Vector and Vector-borne Diseases Control Laboratory (VVBDC), Lanzhou, Gansu Province, CHINA (PEOPLE’S REP. OF).
– Q fever: Anses (Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail), Laboratoire de Sophia-Antipolis, Unité de Pathologie des Ruminants, Sophia-Antipolis, FRANCE.
– Cell Cultures: Istituto Zooprofilattico Sperimentale della Lombardia e dell’Emilia Romagna (IZSLER), Brescia, ITALY.
– Foot and mouth disease: Istituto Zooprofilattico Sperimentale della Lombardia e dell’Emilia Romagna (IZSLER), Brescia, ITALY.
– Japanese encephalitis: Rabies Research Laboratory, Division of Viral Disease, Animal and Plant Quarantine Agency (QIA), Ministry of Agriculture, Food and Rural Affairs (MAFRA), Gyeonggi-do, KOREA (REP. OF).
– Swine influenza: Animal Health and Veterinary Laboratories Agency (AHVLA), New Haw, Addlestone, Surrey, Weybridge, UNITED KINGDOM.
At its September meeting, the Commission observed that nominations for replacement experts at OIE Reference Laboratories were most often received from the Head of the Institute housing the laboratory. Given that the designated expert is a key element in the approval of an OIE Reference Laboratory application, the Commission asked the Council if the Delegate, who is responsible for submitting the initial application, should not also be
responsible for notifying all changes at the Reference Laboratory, including proposals for changes of experts. In follow up, Prof. Caporale reported that the OIE was in the process of both formalising the role of the OIE Delegate in the procedure to replace experts at OIE Reference Laboratories and streamlining the procedure itself. Under the proposed procedure, nominations that had been endorsed by the Commission would receive final approval by the Council at one of its three annual meetings. New experts could be approved and the on-line list of OIE Reference Laboratories updated after each Council meeting rather than waiting for approval at the General Session in May of each year. A Resolution on the process is proposed by the Council for adoption.
A number of Delegates had notified changes in the designated expert at OIE Reference Laboratories in their countries. In each case the Commission reviewed the curriculum vitae of the new expert to ensure that he/she had the appropriate expertise. The names of the seventeen new experts were presented by Prof. Caporale to the Assembly for adoption by Resolution.
Over 30 OIE laboratory twinning projects were underway and eight had been completed. Demand and interest in OIE Laboratory Twinning remained high, with at least 10 applications in the pipeline.
Annual reports were received from 189 out of 193 Reference Laboratories and from all 39 Collaborating Centres for diseases of birds, bees and terrestrial mammals. A new annual report template had been used by the Reference Laboratories for the first time. A detailed analysis of the reported activities was included in the report of the February meeting of the Commission (p. 5). All annual reports would shortly be made available on line.
Finally, Prof. Caparole informed the Assembly that the third International Conference of the OIE Reference Centres would be held in Seoul, Korea (Rep. of) from 14 to 16 October 2014, but that funding was still being sought. The agenda for the Conference would be finalised at the next meeting of the Commission in September 2013.
286. Past ad hoc Group meetings
Prof. Caporale summarised the outcomes of the following ad hoc Groups. Details are found in the Reports of the Commission and their annexes.
a) ad hoc Group on Vaccine Quality related to Rabies (see page 3 of Doc. 81 SG/12/CS2 A; the updated vaccine section of the Terrestrial Manual chapter on rabies was circulated for Member Country comment and is one of the texts proposed for adoption by Resolution).
b) ad hoc Group on Biosafety and Biosecurity in Veterinary Laboratories (see Annex 3 of Doc. 81 SG/12/CS2 A).
c) ad hoc Group on Validation of Diagnostic Assays (see Annex 4 of Doc. 81 SG/12/CS2 A). d) ad hoc Group on Vaccine Quality related to Classical Swine Fever (see Annex 6 of
Doc. 81 SG/12/CS2 B).
e) ad hoc Group on Rift Valley Fever (see Annex 3 of Doc. 81 SG/12/CS2 B).
f) ad hoc Brainstorming Group on New Approaches to Diagnosis: Applied Genomics (see Annex 4 of Doc. 81 SG/12/CS2 B).
g) ad hoc Group on Validation of Diagnostic Tests for Wildlife (see Annex 5 of Doc. 81 SG/12/CS2 B).
287. Proposed ad hoc Groups
Following receipt of a large volume of Member Country comments on the proposed Terrestrial Manual chapter on managing biorisk in the veterinary laboratory and animal facilities, it was agreed that the ad hoc Group on Biosafety and Biosecurity in Veterinary Laboratories should be reconvened. Prof. Caporale reported to the Assembly that the Commission had identified the following topics that could be addressed by ad hoc Groups: a) High throughput sequencing and bioinformatics and computational genomics (HTS-
BCG).
b) Shortening the vaccine registration process when simply updating and incorporating relevant strains in equine influenza vaccines.
288. International standardisation/harmonisation a) Diagnostic tests
Prof. Caporale reminded the Assembly of the decision to include a table in the disease-specific chapters of the Terrestrial Manual that lists the diagnostic methods available for the disease in question alongside the purpose for which the assay has been validated. Each chapter that has been updated since this proposal was approved has included such a table; the first of these chapters will be proposed for adoption at this General Session. Prof. Caporale stated that given that the table better reflects testing purposes and practices, it should gradually replace the current list of prescribed and alternative tests that can be found in both the Terrestrial Manual and the Terrestrial Code.
Following consultations with an expert on test validation and with the OIE expert and author of the Terrestrial Manual chapter on Bovine genital campylobacteriosis, the Commission agreed that a monoclonal antibody-based antigen capture enzyme- linked immunosorbent assay (ELISA) for detection of Campylobacter fetus in preputial washings and other diagnostic samples should be included in the Terrestrial Manual. The developers were asked to provide the OIE expert with a step- wise protocol in the Terrestrial Manual style, for inclusion in the chapter in the next revision cycle.
A query from a Member Country regarding the polymerase chain reaction (PCR) test for contagious equine metritis (CEM) had been referred to the OIE experts for advice. The experts felt that the PCR could be included, in due course, in the Terrestrial Manual chapter as a suitable test for animal movement but they were uncertain if there were currently sufficient validation data.
b) OIE Procedure for Registration of Diagnostic Kits
Prof. Caporale reminded the Assembly that according to the OIE procedure, each kit included in the OIE Register must have its registration renewed every 5 years. Prof. Caporale reported that the diagnostic kits ‘BioChek Avian Influenza Antibody test kit’ and ‘Prionics AG – Check Western’ required renewal, and in accordance with the procedure, the appropriate OIE experts had been consulted and recommended that their registration be renewed. The Commission agreed with this recommendation. A third kit, which would soon be reaching the end of the 5-year term, was still under evaluation.
Prof. Caporale proposed that registration of the diagnostic kits ‘BioChek Avian Influenza Antibody test kit’ and ‘Prionics AG – Check Western’ be renewed.
289. OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (mammals, birds and bees)
In accordance with the approved procedure for updating the Terrestrial Manual, a meeting of the Bureau of the Commission and Selected Experts (‘Enlarged Bureau Group’ [EBG]) had been held prior to each Commission meeting, and the Commission reviewed the recommendations of these EBG meetings. In March 2013, 21 chapters that had been reviewed by the EBG and approved by the Commission for circulation to Member Countries were made available online for consultation as the final versions that would be proposed for adoption.
Prof. Caporale presented these revised chapters to the Assembly for adoption. If adopted, the chapters will be published on the OIE web site.
290. Liaison with other Commissions
The Biological Standards Commission provided advice on a number of topics requested by the Scientific Commission and the Code Commission.
291. Update on OFFLU
OFFLU – the OIE/FAO Network of expertise on animal influenza – held two Executive Committee meetings to review and coordinate the progress of ten technical activities. One of the technical activities run at Friedrich-Loeffler Institute, Germany (OIE Reference Laboratory for avian influenza) achieved its objective by developing a universally usable RNA for H5 avian influenza virus targeted PCR assays. In September 2012, the WHO Meeting on Vaccine Composition in the Northern Hemisphere was held in Beijing (China [People’s Rep. of]); the OFFLU network contributed 118 H5 sequences and 17 H9 sequences to help WHO in pandemic preparedness. OFFLU swine influenza virus group paper on “Review of influenza A virus in swine worldwide” was accepted for publication in the journal Zoonoses and Public Health. An editorial highlighting the OFFLU research agenda was due for publication in the journal Influenza and Other Respiratory Viruses. OFFLU developed a modus operandi document detailing the Terms of Reference for the various committees and different positions within its structure. The OFFLU Annual Newsletter for 2012 compiling the achievements for the year had been prepared.
292. OIE Seminar on New Approaches to Diagnosis: Applied Genomics, 7 June 2013, Berlin, Germany
Prof. Caporale reminded the Assembly that a 1-day OIE Symposium would be held on 7 June 2013 during the WAVLD36 Symposium. The theme of the Seminar was: New
Approaches to Diagnosis: Applied Genomics. The Commission had finalised the programme and the list of speakers.
293. Work plan and activities (as of February 2013)
The Commission felt that the service it provides to the OIE could be extended beyond reviewing Reference Centre applications and updating the Terrestrial Manual. Following discussion, the Commission identified three areas on which it proposed to focus:
a) Evaluating the mandated activities of the OIE Reference Laboratories. b) Laboratory PVS.
c) Coordinating the interactions between the Focal Points for Laboratories and the OIE Reference Laboratories.
Details are found in the Report of the February 2013 meeting of the Commission. The Commission emphasised its willingness to support the work of the OIE in these three areas, and in any other area identified by the OIE Headquarters.
294. The President of the OIE thanked Prof. Caporale for his comprehensive presentation and opened the floor to discussion.
295. The Delegate of Chile thanked Prof. Caporale for his excellent presentation. He requested that the chapters that would be presented for adoption by resolution be made available before the General Session to give the Member Countries enough time to provide comments.
296. The Delegate of Ireland, speaking on behalf of the 27 EU Member States, congratulated the Commission for its essential work and, in particular, its continued efforts to modernise and update the Terrestrial Manual. The EU wished to continue its participation in the Enlarged Bureau Group and those ad hoc Groups that are convened under the auspices of the Biological Standards Commission. The EU thanked the Commission for taking account of its comments on the proposed Terrestrial Manual chapters and supported their adoption. The EU noted that certain disease-specific chapters of the Terrestrial Manual contain a case definition, e.g. the current chapter on Newcastle disease and the proposed chapter on dourine. The EU was in agreement with the Code Commission that case definitions should rather be included in the Terrestrial Code, whereas the Terrestrial Manual should contain references to the case definition in the Terrestrial Code, when necessary, to avoid inconsistencies between the two OIE publications that might lead to trade difficulties. The EU was of the opinion that a case definition for dourine should be developed for inclusion in the Terrestrial Code. The EU invited the Commission to specifically review the Terrestrial Manual chapters on American foulbrood of honey bees and Varroosis of honey bees, taking into account the recent revision of the corresponding chapters in the Terrestrial Code. Finally, with regard to the future of prescribed and alternative tests, the EU strongly suggested that the Commission collaborate closely with the Code Commission so as to agree on a coordinated approach for both OIE Standards.
297. The Delegate of Zimbabwe stated that there did not appear to be simple standardised tests to facilitate assessment of imported marine-derived materials for animal feeds with regard to ciguatera toxins and asked if the Commission could provide assistance. She stated that there is a need to address adulteration of meat from species that are not traditionally in the food system and asked if the sequencing technology identified by Prof. Caporale as a future area of activity for the Commission could be used for this purpose.
298. Prof. Caporale, President of the Biological Standards Commission, agreed with the Delegate of Chile that ample time should be given to Member Countries to provide comments on texts that would be presented for adoption. He pointed out that the Commission had recently reviewed the procedure such that Member Countries now receive the texts, a second time, 60 days before the General Session to make comments. In response to the EU’s comment on case definitions, he said that the Biological Standards Commission was already working with the Scientific and Code Commissions and that this collaboration would continue. Case definitions are essential for disease diagnosis and surveillance. Regarding the two chapters on diseases of honey bees, Prof. Caporale assured the EU that they had already been identified for update. For the question of prescribed and alternative tests, he was of the opinion that it would be better to use the concept of a test that is fit for purpose, including for international trade, as this is a scientifically sound approach. In reply to the Delegate of Zimbabwe, Prof. Caporale stated that meat adulteration was a day- to-day problem that the OIE should address.
299. The President of the OIE gave the floor to Dr Bernard Vallat, Director General of the OIE. Dr Vallat commented that the OIE would organise an evaluation of the twinning programme when the time was right to review and improve the OIE policy in this area in collaboration with the Commission. He went on to state that the selection criteria for twinning projects were not only scientifically based but also took into account other geostrategic priorities (regional or global coverage). On a different matter, Dr Vallat stated that the future ad hoc Group on equine influenza vaccines was a priority for the OIE. On the subject of OIE Reference Laboratory quality management systems, Dr Vallat supported the position of the Biological Standards Commission’s and its President and was of the opinion that the Commission should propose for delisting those Reference Laboratories that did not maintain a quality system. He also supported the involvement of the Biological Standards Commission in the training of the OIE National Focal Points for Veterinary Laboratories and in the laboratory component of the PVS Pathway. In response to the Delegate of Chile, Dr Vallat assured the Assembly that all texts that would be proposed for adoption are sent to Member Countries at least 60 days before the General Session; in the event of accidental non-reception of texts, Delegates are invited to contact the OIE Headquarters. In response to the EU, Dr Vallat supported the development of case definitions in all chapters of the Terrestrial Code, which was already underway. Dr Vallat stated that he would ensure that the Specialist Commissions continue to work in collaboration. Finally, in response to the Delegate of Zimbabwe, Dr Vallat mentioned that toxicity of animal products used in feed was addressed by the OIE Animal Production Food Safety Working Group, which works in collaboration with Codex Alimentarius. He added that while to date, this Group has focused on pathogens, it could consider the issue raised if requested by the Member Countries.
300. The Assembly noted the Report of the Biological Standards Commission. Adoption of Draft Resolution No. 24
Newly designated OIE Experts at OIE Reference Laboratories for Terrestrial Animal Diseases
301. The Assembly unanimously adopted Draft Resolution No. 24. The text appears under Resolution No. 24 at the end of this report.
Adoption of Draft Resolution No. 25
Adoption of the new or revised texts for the Manual of Diagnostic Tests and Vaccines
for Terrestrial Animals
302. The Assembly unanimously adopted Draft Resolution No. 25. The text appears under Resolution No. 25 at the end of this report.
Adoption of Draft Resolution No. 26
Register of diagnostic tests validated and certified by the OIE
303. The Assembly unanimously adopted Draft Resolution No. 26. The text appears under Resolution No. 26 at the end of this report.
TH U R S D A Y 3 0 MA Y 2 0 1 3
SIXTH PLENARY SESSION