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Original: English

February 2021

REPORT OF THE MEETING OF THE OIE BIOLOGICAL STANDARDS COMMISSION

Virtual meeting, 8–9, 11–12 February 2021

PART B

_______

A virtual meeting of the OIE Biological Standards Commission was held from 8 to 9 and 11 to 12 February 2021. 

The list of participants can be found at Annex 1.

Considering the ongoing COVID-19 pandemic, the 88th Annual General Session will be held virtually from Monday 

24 to Friday 28 May 2021. During the 88th General Session new and revised chapters of the OIE International 

standards (the Aquatic Animal Health Code, the Terrestrial Animal Health Code, the Manual of Diagnostic Tests for 

Aquatic Animals and the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals) will be proposed for 

adoption.

To facilitate this process, the February 2021 meeting report of the Biological Standards Commission will be 

distributed in two parts: Part A provides information about the new and revised texts for the Terrestrial Manual

that will be proposed for adoption at the 88th General Session; and Part B (herewith), will provide information about 

other topics discussed at the Commission's February 2021 meeting including the following items to be proposed for 

adoption: new applications for Reference Centre status and the OIE Register of diagnostic kits, as well as other topics 

for information. 

In preparation for the 88th General Session, the OIE will organise a series of information webinars to ensure that 

Members are well aware of the background and key aspects of the standards being presented for adoption. Attendance 

to these webinars will be by invitation only. Please note that Delegates will soon receive detailed information about 

the virtual 88th General Session, and in particular the process for commenting and adoption of standards.

3.2. Request to include instructional training videos in Terrestrial Manual chapters

An expert currently updating one of the Terrestrial Manual chapters requested permission to include in 

it an instructional training video on a diagnostic technique. The Commission considered that while the 

inclusion of such videos could be a useful way of conveying important information, difficulties would 

arise in evaluating and peer-reviewing the videos, editing them or making them available in multiple 

languages. As such videos could be perceived as being officially endorsed by the OIE, the Commission 

agreed to postpone the discussion to its next meeting in September 2021 when the request could be 

analysed along with the training video in question.
2 Biological Standards Commission/February 2021

3.3. Review of the instructions for authors

Following the Commission’s decision to remove recommendations for conducting target animal batch 

safety tests from the vaccine batch release testing sections of individual disease-specific chapters in the 

Terrestrial Manual, when feasible, the Commission approved text for inclusion in the instructions for 

authors reflecting this decision and providing guidance to authors on this new instruction.

3.4. Update from February 2018 meeting: review of a validation dossier for a quantitative real-time

PCR method for detection of Taylorella equigenitalis directly from swabs

The OIE Reference Laboratory experts had completed their review of a validation dossier for a 

quantitative real-time PCR method for detection of Taylorella equigenitalis directly from swabs. The 

experts evaluated the reproducibility of this method and another quantitative real-time PCR and 

recommended their inclusion in the Terrestrial Manual chapter. The Commission would review the data 

at its next meeting in September 2021 before a final decision can be made. 

3.5. Terrestrial Manual status: update on chapters selected for the 2021/2022 review cycle

The Commission examined the status of chapters that had previously been identified for update in the 

2021/2022 review cycle (see September 2020 report). The Commission identified alternative expert 

reviewers for some of the chapters where the current expert is not available.

4. OIE Reference Centres

4.1. Annual reports of Reference Centre activities in 2020

As of 10 March 2021, 217 out of 224 (97%) Reference Laboratories and 58 out of 59 (97%) Collaborating 

Centres had submitted annual reports for 2020 to the OIE. In accordance with the adopted Procedures 

for designation of OIE Reference Laboratories (the SOPs) (https://www.oie.int/en/scientificexpertise/reference-laboratories/sops/) and the Procedures for designation of OIE Collaborating Centres

http://www.oie.int/en/scientific-expertise/collaborating-centres/sops/, the Commission agreed to review 

all the reports, noting in particular the performance of each Reference Centre with regard to fulfilling the 

Terms of Reference (ToR) to the benefit of OIE Member. The Commission expressed its appreciation 

for the continued support and expert advice given to the OIE by the Reference Centres. 

In accordance with the SOPs, those Reference Centres that were not complying with the performance 

criteria will be asked to provide an explanation of their situation; the Delegate will be in copy of all 

correspondence.

The activities relevant to the Terms of Reference of OIE Reference Centres for terrestrial animals are 

summarised in the following graphics:
Biological Standards Commission/February 2021 3

4.2. Applications for OIE Reference Centre status

The Commission recommended acceptance of the following applications for OIE Reference Centre

status:

OIE Reference Laboratory for avian influenza

Reference Laboratory for Veterinary Quality Control on Poultry Production, Animal Health 

Research Institute, Agriculture research Centre, Ministry of Agriculture and Land Reclamation, 7 

Nadi el Seidst.Dokki, Giza, EGYPT

Tel.: (+202) 33.37.09.57 / 33.35.28.97 / 33.38.01.21

E-mail: araby85@hotmail.com 

Web site: www.ahri.gov.eg

Designated Reference Expert: Dr Abdelsatar Arafa.

100%

100%

89%

89%

89%

64%

89%

100%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

1. Activities within the sphere of competence

2. International harmonisation of regulations

3. Maintenance of a network in same specialty

4. Maintenance of a network in other disciplines

5. Provision of consultant expertise

6. Provision of scientific and technical training

7. Organisation of international scientific meetings

8. Coordination of scientific and technical studies

2020 Collaborating Centre Activities
4 Biological Standards Commission/February 2021

OIE Reference Laboratory for brucellosis (Brucella abortus, B. melitensis)

Department of Brucellosis Research, Animal Health Research Institute, Agricultural Research 

Center, Ministry of Agriculture and Land Reclamation, 7 Nadi El-Said Street, P.O. Box 12618,

Dokki, Giza, EGYPT

Tel.: (+201) 222.28.14.76

E-mail: merhamdy@ahri.gov.eg; merhamdy@hotmail.com

Web site: www.ahri.gov.eg

Designated Reference Expert: Dr Mahmoud Hamdy.

OIE Reference Laboratory for contagious equine metritis

ANSES, Laboratory for Animal Health, Normandy site, Physiopathology and Epidemiology of 

Equine Diseases (PhEED) Unit, RD675, 14430 Dozulé, FRANCE

Tel.: (+33-[0]2) 31.79.22.76

E-mail: sandrine.petry@anses.fr

Designated Reference Expert: Dr Sandrine Petry.

OIE Reference Laboratory for bovine viral diarrhoea

National Reference Laboratory for Bovine viral diarrhea/Mucosal Disease, Friedrich-LoefflerInstitut, Federal Research Institute for Animal Health, Institute of Diagnostic Virology, Südufer 10, 

17493 Greifswald – Insel Riems, GERMANY

Tel.: (+49-38351) 7-1212

E-mail: kerstin.wernike@fli.de

Web site: https://www.fli.de/en/institutes/institute-of-diagnostic-virology-ivd/referencelaboratories/nrl-for-bvdmd/

Designated Reference Expert: Dr Kerstin Wernike.

OIE Reference Laboratory for equine influenza 

Equine Research Institute, Japan Racing Association, 1400-4 Shiba, Shimotsuke, 

Tochigi 329-0412, JAPAN

Tel.: (+81-285) 44.0090 

E-mail: manabu_nemoto@jra.go.jp; nemoto_manabu@equinst.go.jp

Web site: http://japanracing.jp/en/about/jra_organization/jeri.html

Designated Reference Expert: Dr Manabu Nemoto.

OIE Collaborating Centre for Economics of Animal Health

University of Liverpool, Centre of Excellence for Sustainable Food Systems, Global Burden of 

Animal Diseases Programme, Institute of Infection, Veterinary and Ecological Sciences, Liverpool, 

UNITED KINGDOM

Tel.: (+44-151) 794.61.13 

E-mail: j.rushton@liverpool.ac.uk

Web site: www.liverpool.ac.uk

Designated Contact Point: Prof. Jonathan Rushton.

This multi-national OIE Collaborating Centre will include participation from the following 

institutions:

Norwegian Veterinary Institute, P.O. Box 750 Sentrum, 0106 Oslo, NORWAY

Tel: (+47-91) 61.85.87

E-mail: edgar.brun@vetinst.no 

Web site: www.vetinst.no

Designated Contact Point: Dr Edgar Brun.

Utrecht University, Department of Population Health Services, Utrecht, NETHERLANDS

Tel.: (+31-30) 253.10.91 

E-mail: j.a.stegeman@uu.nl

Web site: www.uu.nl

Designated Contact Point: Prof. Arjan Stegeman.
Biological Standards Commission/February 2021 5

Reminder: The Commission reviewed the following OIE Reference Centre applications and 

recommended their acceptance in February 2020 and September 2020, respectively:

OIE Collaborating Centre for Good Beekeeping Management Practices and Biosecurity Measures in the 

Apiculture Sector

Istituto Zooprofilattico Sperimentale delle Regioni Lazio e Toscana “M. Aleandri”, via Appia 

Nuova, 1411 - 00178 Rome, ITALY

Tel.: (+39) 06.79.09.91

Email: izslt@legalmail.it

Website: http://www.izslt.it/

Designated Contact Point: Dr Giovanni Formato.

OIE Reference Laboratory for African swine fever 

National Surveillance and Research Center for Exotic Animal Diseases (National Reference 

Laboratory for African Swine Fever), China Animal Health and Epidemiology Center, 

No. 369 Nanjing Road, Qingdao 266032, CHINA (PEOPLE’S REP. OF)

Tel.: (+86-532) 87.83.91.88 

E-mail: zlwang111@163.com; wangzhiliang@cahec.cn

Designated Reference Expert: Dr Zhiliang Wang.

Both Reference Centres will also be included in the resolutions proposed for adoption in May 2021.

An application had been received for an OIE Reference Laboratory for African horse sickness. Before a 

final decision can be made, the applicant would be asked to provide more detailed information on their 

experience in standardisation and validation of diagnostic tests, and to confirm that the laboratory can 

receive samples from other Members. The Commission noted that the proposed expert is currently listed 

as an expert for four OIE Reference Laboratories, which represents a significant workload and a broad 

range of expertise. The Commission also agreed to seek further information about how the expert 

proposes to manage the broad scope of subjects, about what support there is from the other scientific 

staff at the institution and about a succession plan.

Another application had been received for an OIE Reference Laboratory for foot and mouth disease. The 

applicant laboratory had completed a twinning project a number of years ago and the Commission was 

impressed with its activities and competencies. The Commission felt however, that it was too soon to 

endorse the application, that the laboratory needed to acquire more experience, for example of validating 

tests, and producing and distributing reference reagents. The Commission also questioned whether the 

laboratory operated under the containment level required for the work it would need to perform with

FMD virus. The Commission would welcome a future re-submission after the laboratory has developed 

and strengthened its post-twinning activities.

Finally an application had been received for an OIE Reference Laboratory for avian mycoplasmosis

(Mycoplasma gallisepticum, M. synoviae). The Commission found that the application lacked details on 

the provision of international training and consultations, along with organisation of and participation in 

scientific meetings. The applicant would be asked to review these aspects and resubmit the application.

4.3. Changes of experts at OIE Reference Centres

The Delegate of the Member concerned had submitted to the OIE the following nominations for changes

of experts at OIE Reference Laboratories. The Commission recommended their acceptance:

Contagious bovine pleuropneumonia and contagious caprine pleuropneumonia

Dr Lucia Manso-Silvan to replace Dr François Thiaucourt at the Centre international en recherche 

agronomique pour le développement (CIRAD), Campus International de Baillarguet, Montpellier, 

FRANCE

Heartwater

Dr Valérie Rodrigues to replace Dr Nathalie Vachiery at the Centre international en recherche 

agronomique pour le développement (CIRAD), Campus International de Baillarguet, Montferriezsur-Lez, Montpellier, FRANCE
6 Biological Standards Commission/February 2021

Surra (Trypanosoma evansi)

Dr Nick Van Reet to replace Prof. Philippe Büscher at Institute of Tropical Medicine, Department 

of Parasitology, Antwerp, BELGIUM

The Commission reviewed an additional nomination for a change of expert at an OIE Reference

Laboratory and felt that the nominee, being an epidemiologist rather than a laboratory-based expert on 

disease diagnosis and control, would not fulfil the expectations of an OIE Expert. In accordance with the

proposal to amend the Guidelines for applicants for OIE Reference Laboratory status (see Item 4.5), the 

Commission agreed to request information about the multidisciplinary team to which the nominee 

belongs to determine that all aspects of disease diagnosis and control will be covered and that the required 

level of expertise is available within the Reference Laboratory.

4.4. Review of new and pending applications for laboratory twinning

As of February 2021, 66 projects have been completed, 29 projects are underway and 11 are awaiting

funding before beginning.

One Laboratory Twinning project proposal was presented for the Commission’s review:

● United Kingdom – Sierra Leone for rabies: the Commission supported the technical contents of

this project.

4.5. Follow-up on the consultation with the Council

In February 2020, the Commission had sought the opinion of the Council on three issues. The following 

is a summary of the issues and the proposed way forward.

4.5.1. Appointment of OIE Reference Laboratory experts

The Commission has observed a diversity in the nominations received for OIE Reference 

Laboratory experts. Some Delegates appoint subject-matter experts (technical profile) while 

others appoint the Head of the institution to which the laboratory is associated (management 

profile). The Commission asked if the designation of an OIE Reference Laboratory expert who 

has responsibility for the management of the laboratory, but who is not necessarily a subjectmatter expert, a contravention of the ToR1

? 

Given that it is understood that the designated expert works within a team, the Council agreed 

a management profile for the nominated expert was acceptable if the expertise available within 

the laboratory team provided the required technical aspects. The Council agreed that the 

Commission should amend the Guidelines for applicants for OIE Reference Laboratory status

and the CV template to include a request for information about the team to determine that all 

aspects of disease diagnosis and control are covered and that the required level of expertise is 

available within the Reference Laboratory. 

4.5.2. Applications from private companies for Reference Centre status

The Council informed the Commission that it had no objection, in principle, to applications for 

OIE Reference Centre status from the private sector, but the transparency of the OIE-related 

activities undertaken by such Reference Centres should not be compromised.

To ensure that the same transparency principles as those for public institutions are applied, 

applications from the private sector should provide information on: how the institute is 

integrated into the national Veterinary Services; how the applicant plans to differentiate OIErelated activities from private activities; and how the applicant plans to address the issue of 

transparency of its OIE-related activities. The applicant should also be reminded of the necessity 

to report conflicts of interest to the OIE annually through the Declaration of Interests form.

1 ToRs: Terms of Reference
Biological Standards Commission/February 2021 7

If the applicant is officially designated, the Centre should be periodically monitored by 

responding to the questions on: the profitability of its activities as an OIE Reference Centre as 

opposed to its other activities; on the benefits of being an OIE Reference Centre to the rest of 

its commercial activities or to the Veterinary Services of the host country or to the region; on 

how any conflicts of interest that arise were managed; and on any other relevant matters specific 

to the Centre’s ownership, management structures and work that could create a perception of 

conflict of interest.

The information provided when evaluating an application and when reviewing activities once 

designated should satisfy the Specialist Commission and the OIE that the Centre is complying 

with expectations regarding transparency and the management of conflicts of interest.

The Commission proposed that guidelines be developed on how to evaluate the declared 

conflicts of interest and the practicalities of implementing transparency principles when dealing 

with the private sector.

4.5.3. Lack of testing of international samples by OIE Reference Laboratories 

On analysing the annual reports, the Commission has identified 51 OIE Reference Laboratories 

that did not report any international diagnostic testing on samples. As international testing is 

one of the core functions of an OIE Reference Laboratory, these laboratories were sent a short 

survey to identify the reasons for this lack of international diagnostic testing.

A total of 38 laboratories replied to the questionnaire giving the following reasons: no request 

was received from other countries (25); preference for other OIE Reference Laboratories for 

submission of samples (8); disease was absent in the region in the reporting period (3); and 

difficulty in transporting samples to the Reference Laboratory (2). Some respondents also 

mentioned that the national laboratories use the OIE Reference Laboratories to request reference 

materials, for test method development and validation, and for training and advising on the 

diagnosis of diseases in certain cases. Thus, the samples are mostly being tested at the national 

level, not requiring the testing services of the OIE Reference Laboratory. 

To address this issue, it was agreed that the annual report template could be amended such that 

when a Reference Laboratory clicks “no” to the Question 1: Did your laboratory perform 

diagnostic tests for the specified disease/topic for purposes such as disease diagnosis, screening 

of animals for export, surveillance, etc.?, a follow-up question is asked as to the reason for this 

lack of testing. This way, the Biological Standards or Aquatic Animal Health Standards 

Commissions can understand the situation and decide if further action is needed.

● Reference Laboratories – implementation of the SOPs2

4.6. Follow-up September meeting: further feedback from the Laboratories that are not complying

with the key ToR according to their 2018 annual report

The Commission further reviewed the feedback received from Reference Laboratories that were not 

complying with key performance criteria according to their 2018 annual reports. No response had been 

received from a laboratory that stated that it was no longer permitted to work on the disease in question 

as the country was free from this disease. Several reminders were be sent to the Delegate of the country 

with the laboratory in copy, but no response was received. Another laboratory had still not achieved 

accreditation to ISO 17025 or equivalent quality management system despite requesting two 6-month 

2 SOPs: Standard Operating Procedure
8 Biological Standards Commission/February 2021

extensions to the deadline. Both laboratories will be asked to submit an official letter requesting that their

OIE Reference Laboratory designation be voluntarily revoked in accordance with Article 9 of the Internal 

rules for OIE Reference Centres, with consideration of further steps on the basis of response to this 

request.

4.7. Feedback from the Laboratories that are not complying with the key ToR according to 2019 annual

report

The Commission reviewed the feedback received from 11 Reference Laboratories that were not 

complying with key performance criteria according to their 2019 annual reports. The Commission also 

verified the performance of some of these laboratories as illustrated in their 2020 annual reports. The 

Commission accepted the explanations provided by ten laboratories and was satisfied with the efforts 

taken by those laboratories to address the lack of activity. 

The reason given by one laboratory reporting a low level of activity was the low incidence of disease in 

question in the region. The laboratory will be advised to contact national laboratories in other regions 

where the disease is prevalent and organise proficiency testing with them. 

One laboratory had made many mistakes in filling in the annual report template, which it then corrected 

following receipt of feedback from the Commission in September. The laboratory will be informed that 

reporting is a key part of the ToR and care should be taken when reporting activities to the OIE. 

One laboratory stated that its underperformance in the area of international activities is primarily due to 

its success in expanding diagnostic capacity within the region. The laboratory gave assurances that there 

would be improvements in its performance in the coming years. 

Two laboratories – for Crimean–Congo haemorrhagic fever (CCHF) and for Rift Valley fever (RVF) –

had not submitted annual reports for 2019. The laboratories proposed submitting new applications for 

joint Reference Laboratory designations in partnership with other institutions. The Commission did not 

agree to this request as it no longer accepts applications for joint Reference Laboratory status. As they 

are unable to fulfil the ToR, the laboratories will be asked to consider revoking their OIE Reference 

Laboratory status in accordance with Article 9 of the Internal rules for OIE Reference Centres. This 

withdrawal will mean that there are no OIE Reference Laboratories for CCHF and only one for RVF. 

The Commission is aware of the importance of these two disease in the sub-Saharan Africa region, and 

of the existence of the required capacity in certain laboratories in this region and would encourage 

laboratories having the necessary capacity and expertise to submit applications for OIE Reference 

Laboratory status for these diseases.

One laboratory had not replied to the request for feedback despite several reminders. A final reminder 

letter will be sent to the Delegate of the country with the laboratory in copy. Should no response be 

received by the next meeting, the laboratory’s designation could be revoked in accordance with Article 

9 of the Internal rules for OIE Reference Centres.

4.8. Annual report for Reference Laboratories for Rinderpest: adapted template

As the September 2020 meeting the Commission identified various key elements that would facilitate 

the reporting of activities by laboratories designated for eradicated diseases, and developed a new 

reporting template for the OIE Reference Laboratories for Rinderpest. The new template and guidance 

document were sent to the four OIE Reference Laboratories to use for the annual report of activities in 

2020. 

The Commission reviewed the four annual reports submitted and noted some proposals for improving 

the template, in particular the terminology used.
Biological Standards Commission/February 2021 9

4.9. Further develop the SOPs to include provisions for suspending laboratories and for laboratories

temporarily with no expert

The Procedures for the designation of OIE Reference Laboratories (SOPs) were adopted in 2017 and 

have been implemented by this Commission and the Aquatic Animal Health Standards Commissions 

since then. More recently, it has become apparent that parts of the SOPs need to be updated, for example 

the time line for the achievement of accreditation to a quality management system can be deleted from 

the SOPs as the final deadline of 31 December 2019 is past. Implementation of the SOPs has also 

revealed the need for a procedure for temporary suspension of OIE Reference Laboratory status, for 

example because of temporary lack of diagnostic ability due to construction or restructuring of the 

laboratory’s facilities. The need was also identified for a procedure to be followed when the nomination 

for a replacement expert is not endorsed by the Specialist Commission leaving a laboratory without a 

designated expert for a short period of time. The Commission reviewed and approved text proposed by 

the Secretariat to address these issues. The SOPs would now be reviewed by the Aquatic Animal Health 

Standards Commissions and presented to the Director General for endorsement. If endorsed, the amended 

SOPs would be appended to the report of the next meeting of the Biological Standards Commission and 

uploaded to the web page. 

● Collaborating Centres – implementation of the SOPs

4.10. Postponed from September: feedback on the mapping exercise for the existing Centres against the

list of main focus area and specialties

At the February 2020 meeting, the Commission noted that a Centre in the Americas region had been 

miscategorised based on an analysis of the annual report and proposed a new focus area and speciality 

that better match the Centre’s activities. In accordance with its title, the Centre was asked to concentrate 

on activities related to emergency preparedness and response for animal health emergencies during 

natural disasters such as earthquakes, floods, tsunami, etc., and contingency planning. The Centre agreed 

with the proposed new focus area and speciality, but informed the Commission that it would like to 

broaden the Centre’s activities to include management of health emergencies caused by disasters using 

a multi-hazard approach. At the February 2021 meeting, the Commission accepted the Centre’s 

explanations and proposals; the Centre will continue to be an independent Centre in the region.

Another Centre in the Americas region that was categorised under focus area ‘Training and education’ 

requested the Commission to consider allowing it to also work and report on activities under other focus 

areas including animal health management, animal production and veterinary products. The rationale

provided by the Centre is that it is unique in the region and provides a broad spectrum of technical 

services to Members in the region. The Commission believed that all the four focus areas cannot be 

combined within one Centre and asked the Centre to consider dividing up into separate Centres for each 

focus area; in some cases, the Centre would need to form a consortium with existing Centres in the 

region.

In the Europe region, one Centre that had been asked to form a consortium with another Centre in the 

same country with overlapping activities, agreed to the proposal and requested guidance on how to form 

the consortium. The Centre also asked could it maintain its status for the remaining speciality area ‘food 

safety’ by including ‘feed safety’ in the title to become OIE Collaborating Centre for Food and Feed 

Safety in the region. At the February 2021 meeting, the Commission determined that food safety and 

feed safety are separate and that the Centre would need to submit a separate application for Collaborating 

Centre status for feed safety as this is a new domain. With regard to its food safety mandate, the 

Commission invited the Centre to form a consortium with the already existing Centre in the region. The 

necessary guidance to establish the consortium will be provided.
10 Biological Standards Commission/February 2021

4.11. Follow-up September: feedback from the Centres that are not complying with the key ToR

according to 2019 annual report

The Commission reviewed the feedback received from two Collaborating Centres that were not 

complying with key performance criteria according to their 2019 annual reports. The Commission 

accepted the explanation provided by both Centres. 

The Commission advised the first Centre to better use the annual report template in order to describe all 

the activities covered in their ToR. The report is a way to gain visibility for the Centre’s activities: the 

Commission therefore expects to see evidence that the Centre is playing an active role in collaborative 

research programmes, publishing widely in the area of expertise, and contributing to updating the 

relevant Terrestrial Manual chapters.

For the second Centre, the Commission appreciated the efforts it is taking to improve its performance 

and looks forward to reviewing the 2020 annual report. 

4.12. Follow-up September: feedback on the review of the 5-year work plans received from

Collaborating Centres

Following the September 2020 meeting, 11 Collaborating Centres that had submitted incomplete 5-year 

work plans were asked to provide more information on their profile, networks, international 

collaboration, specific details in their work plans including time frames for activities or missing 

authorisation signatures. Two Centres that submitted identical work plans were asked to submit 

individual workplans or consider merging the Centres into one. Reminders were sent to those Centres 

that had not submitted their work plans. 

At the February 2021 meeting, the Commission reviewed the feedback received from ten Centres and 

approved the corrections to the 5-year work plans. One Centre will be asked to clarify how they plan to 

implement activities that were not completed in year 2020 due to Covid-19 pandemic situation.

Two Centres that had submitted identical workplans, resubmitted thoroughly revised individual work

plans for each Centre and the Commission found them satisfactory.

One Centre that did not provide feedback will be reminded to submit their completed work plan by 

correcting the period to 2020–2024, listing the activities in the activity table under each ToR including

time frames in months, and signing the document.

The Commission reviewed the new 5-year work plans received from Centres that had not previously 

submitted one, and approved the range of activities proposed by two Centres and their relevance to the 

identified main focus areas and specialties. One Centre that is categorised under the focus area ‘Training 

and education’ reported a broad range of activities in their work plan covering other focus areas including 

animal health management, animal production, veterinary products and wildlife health and biodiversity. 

The Centre will be asked to revise the plan to reflect activities in focus area ‘Training and education’; 

the Centre would need to apply for designation as separate Collaborating Centre in the other focus areas 

before 5-year work plans would be requested and review. Four Collaborating Centres that had still not 

submitted a work plan would be sent a reminder.

5. Ad hoc Groups

● Update on activities of ad hoc Groups

5.1. Ad hoc Group on Replacement of the International Standard Bovine Tuberculin

This ad hoc Group has been meeting for the past 5 years, with the primary task to develop a new ISBT3.

This was in recognition that the present bovine international standard, developed and maintained by

WHO, was running out and deteriorating. WHO agreed that it would be appropriate for OIE to develop

the new standard.

3 ISBT: international standard for bovine tuberculin
Biological Standards Commission/February 2021 11

The Group met by video conference on 9 December 2020 and 12 January 2021 to discuss, finalise, and 

endorse a revised version of the protocol used to assess the potency of the candidate tuberculin that had 

been identified as a suitable replacement for the current ISBT.

The decision to revise the original protocol was made to address some concerns raised by external experts

regarding the procedures to evaluate the potency of the candidate tuberculin against the current ISBT, as

well as the methods to conduct data analysis and interpret test results.

The revised protocol describes additional testing procedures to assess the potency of the candidate

tuberculin as well as the preferred method to perform the statistical analysis.

Preliminary results identified some issues with the assigned potencies as compared with the ISBT in 

both trials. The Group discussed several hypotheses that could explain the results and agreed on the need 

to conduct another trial with a new M. bovis AN5 strain to confirm the hypothesis. The results will not 

be ready by May 2021 and, consequently, the new international standards will not be ready for adoption 

at the 88th General Session. The Resolution to adopt the new ISBT will thus be postponed to 2022.

5.2. Expert consultation to review the OIE Terrestrial Manual chapter 3.4.6 Bovine tuberculosis

Work on updating the chapter in the OIE Terrestrial Manual is continuing with the aim of having a draft 

ready for review at the next meeting of the Commission in September this year. Following two rounds 

of Member comment, the chapter could be proposed for adoption in May 2022.

5.3. Ad hoc Group on Sustainable Laboratories, 11 December 2020

The OIE convened a brief virtual meeting of the ad hoc Group on Sustainable Laboratories in December

2020 to inform them of the advancements on the economics component of the project. The Group was

introduced to the Economics Team from the University of Liverpool and the Institute for Infectious

Animal Diseases of Texas A&M University (IIAD), the latter being the OIE Collaborating Centre on

Biological Threat Reduction. The Economics Team briefed the Group on the work done to date, and

discussed the economic sustainability key performance indicators (KPI) proposed for integration into the

PVS4 Sustainable Laboratories Tool.

As main outcomes, the Group expressed its appreciation of the work, proposals, and presentations of the

Economics Team and agreed that the work of the Team’s was advancing well and in the right direction.

The Group provided initial feedback to the Economics Team on which KPIs for economic sustainability

are the most important ones that merit focus moving forward, and on the gaps and missing indicators.

The Group proposed that each KPI should be reviewed in-depth and further consultation with the Group

was needed. As a result, the Economics Team developed an expert elicitation exercise to collect the

Groups’ point of view on the importance and feasibility of each KPI and ranking them regarding

application, importance, availability of data, and benchmarking. Whether the exercise will be conducted

more broadly involving Laboratory Focal Points or OIE Experts is being considered.

The next full AHG virtual meeting is tentatively targeted for the first semester of 2021. During the next

meeting, the experts will discuss the progress on the enhanced tools (improvements made, testing, etc.),

be briefed on the planned pilot remote mission, provide feedback and recommendations, finalise values

and unit costs for the models, and endorse the streamlined data collection and visualisation tools.

4 PVS: Performance of Veterinary Services
12 Biological Standards Commission/February 2021

5.4. Ad hoc Group on the revision of Terrestrial Code chapters regarding the collection and processing

of semen of animals, 9 November 2020 to 15 January 2021

At its September 2019 meeting, the Code Commission had requested that an ad hoc Group be convened 

to revise Terrestrial Code Chapter 4.6 General hygiene in semen collection and processing centres, and 

Chapter 4.7 Collection and processing of bovine, small ruminant and porcine semen, as well as 

provisions in relevant disease-specific chapters of the Terrestrial Code and the Terrestrial Manual, in 

order to resolve inconsistencies among the chapters and ensure that relevant texts reflect the latest 

scientific evidence and best practices regarding risk mitigation measures in the collection and processing 

of semen of animals. The ad hoc Group was also requested to consider the inclusion of provisions to 

address equine semen in these chapters. 

The OIE Secretariat for the Code Commission updated the Biological Standards Commission on the 

work of the ad hoc Group, which had met virtually on two occasions between November and December 

2020. The Group was focusing on Chapter 4.6 before starting any work on Chapter 4.7. The ad hoc

Group had proposed a new draft structure for Chapter 4.6, which had been reviewed and approved by 

the Code Commission, which also provided some further guidance on the holdings and species to be 

covered in the chapter. 

The Code Commission requested that the ad hoc Group be reconvened to continue this important work 

and finalise its report prior to the next meeting of the Commission in September 2021.

6. International Standardisation/Harmonisation

6.1. OIE Register of diagnostic kits

6.1.1. Update on new or renewed applications

The Secretariat for Registration of Diagnostic Kits (OIE SRDK) informed the Commission of 

the current status of the OIE Register of diagnostic kits. At present, there are 13 registered kits; 

four new applications (submitted in 2019 and 2020) and one application for extension of claim 

(submitted in 2020) are in various stages of review. One application (submitted in 2019) was 

withdrawn. 

The Commission endorsed renewal of the Pourquier® IIF Taylorella equigenitalis kit (IDEXX 

Laboratories) for a 5-year period (until 2026). An OIE Resolution will be prepared accordingly 

for the 88th OIE General Session in May 2021.

The Commission also endorsed deferring the renewal of the Rapid MERS-CoV Ag Test 

(BioNote Inc.), and endorsed a List of Questions to be addressed to the manufacturer requesting 

additional information to demonstrate that the Rapid MERS-CoV Ag Test (Bionote Inc.) is still 

fit for the purposes as specified in its 2016 registration, including additional information on the 

test’s specificity and sensitivity, and potential cross-reactivity with COVID-19. 

The Commission endorsed moving the renewal date for the Check&Trace Salmonella (CheckPoints B.V.) to 2025, as this kit had undergone scientific evaluation for an extension of claim 

in 2020. 

One diagnostic kit renewal will commence in 2021 (for renewal in the year 2022): 

Mycobacterium bovis Antibody Test Kit (IDEXX Laboratories). 

6.1.2. Endorsement of updated SOP for OIE Register of diagnostic kits

The OIE SRDK had introduced changes to the Standard Operating Procedure (SOPs) for OIE 

Registration of Diagnostic Kits and the Application Form for the Certification of Diagnostic 

Kits validated as fit for specific purposes (Application Form) after consultation with OIE 

Collaborating Centres and the industry association for animal diagnostic kits. 
Biological Standards Commission/February 2021 13

These changes aimed to bring the guidance in these documents up to date with the application 

of the current procedure, recognising that a more thorough update of the SOP may need to be 

scheduled in the future. The proposed changes to the SOPs concerned principally the addition 

of information regarding provisional recognition, and the allowed timeframe for applicants to 

prepare responses to the Review Panel’s questions. The proposed changes to the Application 

Form related principally to the addition of information to the instructions provided to applicants 

in Sections 2, 3 and 4 to assist applicants in preparing their response, the addition of more 

detailed references to the OIE Terrestrial Manual and Aquatic Manual, and changes to the 

question on the intended purpose of test (Section 2.2.3). 

These changes were endorsed by the BSC and are provided in this document.

The Commission agreed with the proposal and, subject to corresponding endorsement by the 

Aquatic Animal Health Standards Commission and Director General approval, agreed that the 

revised SOP should be posted on the OIE website to replace the current version, so all applicants 

will be fully informed of the new procedure. 

https://www.oie.int/en/scientific-expertise/registration-of-diagnostic-kits/procedure-forsubmission/

https://www.oie.int/en/scientific-expertise/registration-of-diagnostic-kits/downloadapplication-form/ 

7. Resolutions for the General Session

7.1. Resolutions that will be presented in May 2021

The Commission noted that the following resolution would be proposed for adoption at the General 

Session in May 2021:

• A resolution proposing the adoption of the 38 draft chapters for the Terrestrial Manual;

• A resolution proposing the new OIE Collaborating Centres.

The following resolutions would be proposed for adoption by the alternative procedure before the 

General Session in May 2021:

• A resolution proposing the new OIE Reference Laboratories for terrestrial animal diseases;

• A resolution proposing the renewal of an already registered diagnostic kit to the OIE Register.

8. Conferences, Workshops, Meetings

● Future Conferences, Workshops, Meetings

8.1. WAVLD5International Symposium, Lyon, France 2023

The 20th International Symposium of the WAVLD was to have been held in Lyon, France in 23–26 June 

2021. Traditionally, the Biological Standards Commission organises a 1-day seminar held during the

WAVLD Symposium. The OIE is a member of the Scientific Committee of the International Symposium.

Due to the COVID-19 pandemic and travel restrictions and difficulties around visa, air travel and

requirements, the WAVLD Executive board has decided that:

• the face-to-face symposium should not be held as a virtual event;

• the symposium should be postponed and occur in June 2023 in Lyon, France.

5 WAVLD: World Association of Veterinary Laboratory Diagnosticians
14 Biological Standards Commission/February 2021

The One Health concept will be a major theme of the symposium and, given the COVID-19 pandemic,

the spotlight on laboratory diagnosis, and significant work at the OIE related to laboratory sustainability,

emergency preparedness, and resilience, the theme of the OIE seminar is currently proposed to be “The

Veterinary Laboratory Function and COVID-19: How can we apply lessonslearnt for better preparedness

and resilience?” Given the postponement of the event, the finalisation of the agenda and speakers for the

OIE seminar will be postponed until February 2022.

9. Liaison with other Commissions

9.1. Horizontal issues among the Specialist Commissions

9.1.1. Update on case definitions

In February 2020, the OIE Secretariat drafted a concept note on case definitions to inform the

Specialist Commissions of the need to revise or develop case definitions of OIE-listed terrestrial

animal diseases to support Member notification. In September 2020, the first tranche of nine

priority diseases was approved by the Scientific Commission following consultation with the

Code Commission: theileriosis in cattle, equine influenza, surra (Trypansoma evansi), 

leishmaniosis, dourine (Trypanosoma equiperdum), Crimean–Congo haemorrhagic fever, 

Nipah virus encephalitis, Q fever and tularemia.

The Biological Standards Commission was presented with a Table showing the status of the 

nine diseases in the first tranche. Four case definitions were presented to the Biological 

Standards Commission: equine influenza, dourine, surra and leishmaniosis. The Commission 

commended the progress made and provided some comments on the case definition for infection 

with equine influenza virus for consideration by the Scientific Commission, and encouraged the 

OIE Secretariat to continue with the development of case definitions for OIE-listed diseases on 

the workplan.

9.1.2. SOP for determining if a pathogenic agent of terrestrial animals meets the OIE definition for an

emerging disease

According to Article 1.1.4. of the Terrestrial Code, Veterinary Authorities shall notify the OIE 

when an emerging disease has been detected in a country, zone or compartment, and send 

periodic reports subsequent to a notification for the time necessary to have reasonable certainty 

that the disease has been eradicated or the situation has become stable, or until sufficient 

scientific information is available to determine whether it meets the criteria for inclusion in the 

OIE List as described in Chapter 1.2.

Despite the fact that a definition for emerging disease is provided in the Glossary of the 

Terrestrial Code, there is no systematic process to determine that an emerging disease of 

terrestrial animals meets the definition for an emerging disease, and as a result Members are not 

consistent in their interpretation of the definition, which has caused inconsistencies regarding 

notifications of emerging diseases from Members.

In order to facilitate the reporting of emerging diseases of terrestrial animals by Members with 

a transparent and consistent approach, further guidance to Members, beyond the definition for 

emerging disease, as to when a disease can be considered to meet the OIE definition of an 

emerging disease, is needed. Furthermore, the means through which the information on 

emerging diseases notified by Members is considered by the OIE and the process to determine 

the outcomes described in Article 1.1.4. requires elaboration.

To solve this issue, the OIE developed an SOP that describes the sequence of steps for the 

determination of an emerging disease, and roles and responsibilities of relevant entities. To 

facilitate its implementation, the SOP is supported by a guidance document for the interpretation 

of the definition for emerging diseases.

Both the SOP and the guidance document were presented to the Biological Standards 

Commission for information and comment. The Commission provided feedback for 

consideration by the Scientific Commission.
Biological Standards Commission/February 2021 15

The Commission was informed that the SOP will be available in the OIE website after Scientific 

Commission’s consideration and Director General approval. 

9.2. Scientific Commission for Animal Diseases

9.2.1. Feedback on review of Collaborating Centre application on Economics of Animal Health

The Scientific Commission was asked its view on an application received for an OIE 

Collaborating Centre on Economics of Animal Health (Europe region). The Scientific

Commission was informed that the application is a milestone within the OIE-led project Global 

Burden of Animal Disease (GBADs) (https://oiebulletin.com/?p=11531&lang=fr). The 

Scientific Commission noted that determining the global burden of animal disease is an 

important tool to justify funding of disease control programmes and also contributes to the risk 

assessment process informing, in particular, the consequence assessment step. Furthermore, the 

development of uniform methodologies to estimate the economic impact of disease will allow 

valid comparisons between different regions. The Scientific Commission noted that overlaps 

might be present between the proposed Collaborating Centre and the Risk Analysis & Modelling 

OIE Collaborating Centre Consortium based at the Royal Veterinary College and the Animal 

and Plant Health Agency (UK). The Scientific Commission fully endorsed the proposal, and 

recommended links be established with other OIE Collaborating Centres working in the field of

epidemiology.

9.3. Terrestrial Animal Health Standards Commission

Matters discussed between the Terrestrial Animal Health Standards Commission and the Biological

Standards Commission

9.3.1. Updates from the September 2020 Code Commission meeting

The Biological Standards Commission was updated by the Secretariat on the current topics 

under review by the Code Commission, and provided the Secretariat of the Code Commission 

with an update of the Terrestrial Manual chapters under review.

9.3.2. Questions on draft Chapter 12.7 Infection with Theileria equi and Babesia caballi (equine 

piroplasmosis)

In draft Chapter 12.7 Infection with Theileria equi and Babesia caballi (equine piroplasmosis), 

Article 12.7.5 Recommendations for the importation of equids, the Biological Standards 

Commission agreed with a comment that Veterinary Authorities should require the presentation 

of an international veterinary certificate attesting that the animals were subjected to a serological 

and agent identification test with molecular techniques for the detection of T. equi and 

B. caballi. This recommendation aligns with the Terrestrial Manual chapter and was stated 

previously by the Biological Standards Commission: “The Biological Standards Commission 

emphasised that positive serology findings without clinical or pathological signs would require 

a combination of tests to confirm infection in a subclinically infected carrier. A combination of 

PCR and serological tests is essential to determine whether an animal is free from infection”

(from report of the February 2020 meeting).

9.3.3. Question on Chapter 8.3 Infection with bluetongue virus

The Biological Standards Commission was informed that the IETS6 has amended the 

categorisation of bluetongue under the current IETS embryo categorisation system relating to 

disease risks in in-vivo derived bovine embryos. Category 1 was amended to state: Bluetongue 

virus, excepting BTV-8 and BTV-8 be added to category 4. The Commission, in consultation 

with an OIE Reference Laboratory expert, determined that the changes would not have an 

impact on the Terrestrial Manual chapter.

6 IETS : International Embryo Transfer Society
16 Biological Standards Commission/February 2021

9.3.4. Question on Chapter 11.10 Infection with Theileria annulata, T. orientalis and T. parva

For Chapter 11.10 Infection with Theileria annulata, T. orientalis and T. parva, Article 11.10.5 

Recommendations for importation from countries or zones not free from infection with 

Theileria, the Code Commission had received technical questions on diagnostic methods and 

timing of tests. The Biological Standards Commission referred these technical questions to the 

Reference Laboratory expert for advice.

9.3.5. Question on Chapter 10.4 Infection with high pathogenicity avian influenza viruses

The Code Commission had received a comment requesting the development of a procedure to 

identify low pathogenic avian influenza viruses having proven natural transmission to humans 

and causing severe consequences. The question arose due to the proposed modification of the 

OIE listed diseases to include zoonotic low pathogenicity avian influenza viruses and how to 

differentiate between high pathogenicity and low pathogenicity avian influenza with zoonotic 

potential. The Biological Standards Commission noted that the current Terrestrial Manual

chapter, which had been thoroughly revised and updated and would be proposed for adoption 

this May, contains the procedures and criteria for assessment of pathogenicity.

9.3.6. Question on Chapter 12.2 Infection with Taylorella equigenitalis (contagious equine metritis)

In Chapter 12.2 Infection with Taylorella equigenitalis, Article 12.2.4 Recommendations for 

importation of stallions or mares, the Biological Standards Commission agreed to clarify that 

horses were subjected to T. equigenitalis identification tests (culture for T. equigenitalis or 

molecular testing), with negative results. The Commission did not agree with the proposal to 

replace “horses” with “the donor stallion” in the following sentence because the Article covers 

stallions or mares.

9.4. Aquatic Animal Health Standards Commission

9.2.1. Feedback on review of Collaborating Centre application on Economics of Animal Health

The Commission was impressed with this strong application and was pleased that aquatics was 

one of the central targeted areas of activity. The Commission fully endorsed the application. 

10. Matters of Interest for Information

10.1. Update on OFFLU

The Commission was briefed on the OFFLU7’s contribution to the WHO Consultation on the 

Composition of Influenza Virus Vaccines of data on avian influenza (AI) and swine influenza (SI) for

the period February to September 2020. A significant amount of genetic and antigenic data on zoonotic

animal influenza viruses was shared with WHO at the September 2020 vaccine composition meeting.

Animal health laboratories in countries representing Africa, Asia, Oceania, Americas and Europe

contributed sequence data for 50 H5, 13 H7 and 29 H9 subtypes and antigenic data for selected AI

viruses. Additionally, a summary of H1 and H3 global swine influenza A virus events with genetic and

antigenic analyses was submitted. These data were used by WHO to update the candidate vaccine viruses

for production of human vaccines against zoonotic viruses of concern. The data collection for the

February 2021 WHO meeting is currently underway.

Due to COVID-19 pandemic situation, several short OFFLU Committee meetings were arranged to bring

together the core group of experts to discuss the strategic and operational activities of the network. The

OFFLU executive committee held discussion with various technical activity leaders (avian, swine,

equine, wildlife, epidemiology, socioeconomics) to elaborate the OFFLU work plan to deliver in 2021.

7 OFFLU: Joint OIE-FAO Network of Expertise on Animal Influenza.
Biological Standards Commission/February 2021 17

Equine influenza experts participated in the OIE panel of equine influenza expert meeting virtually in

April 2020 to update the vaccine recommendations for the equine industry in 2020.

The swine influenza experts met virtually in December 2020 and shared data about the global swine

influenza situation in pig populations by providing regional and country-specific reports from Asia,

Europe, and Americas.

10.2. Update on rinderpest

The Commission was informed that the FAO8-OIE JAC9 had its 16th meeting on 8 December 2020 by

videoconference hosted by FAO. There were no new research applications or RHF10 applications for

review by the JAC at that meeting. The Committee received an update on the status of the application 

from India for an RHF, which has reached the stage where a site inspection is required before further

discussion. The JAC was also updated on the activities of the RHF network. Since the Sequence and

Destroy project was completed, there has been little to report from The Pirbright Institute, United

Kingdom. CIRAD11, France, has established a vaccine seed bank for global use with support from FAO.

FADDL12, USA, has been validating virus inactivation methods of extracted and lyophilised materials to

meet the requirements of the Federal Select Agent Program and PIADC13 Biosafety, in order to proceed

with a Sequence and Destroy project. The extension of shelf-life of LA-AKO RP vaccine from 4 to

5 years was officially approved by the national authority of Japan. IVDC14, China (People’s Rep. of),

will seek approval from the FAO-OIE Rinderpest Secretariat for a Sequence and Destroy project. The

online secure database system that is hosted by the OIE and serves as the global inventory for RVCM15

is undergoing maintenance due to a malfunction that does not impact its security.

The Commission was informed that the OIE is preparing a call for proposals to undertake a risk

assessment of rinderpest re-introduction 10 years after its eradication, considering the current distribution

of RVCM and emerging technologies. This work will include a review of progress done in sequestration

and destruction over the past 10 years. At present, seven countries hold RVCM outside an RHF. Vietnam

is expected to destroy its RVCM during the firstsemester of 2021. Finally, the Commission wasinformed

that FAO and OIE are in the process of signing a co-branding agreement applicable to past and future

rinderpest communication materials.

10.3. Update on COVID-19

The Commission was updated on the activities of the OIE in response to COVID-19. The OIE remains

fully mobilised and is working with its network of experts and partners, including WHO and FAO, to

support its Members in responding to this One Health crisis by taking a multi-sectoral approach. Through

the support of the ad hoc Group on COVID-19 and the human–animal interface, the OIE is regularly

assessing the reports of both natural and experimental infection in animals to inform the development of

risk-based guidance. This includes regularly reviewing and updating the Questions and Answers Page

on the COVID-19 Portal, a list of events reported by OIE Members of natural infection of animals with

SARS-CoV-2 and the OIE Technical Factsheet on Infection of animals with SARS-CoV-2. The 

Commission was also updated on the work of the OIE ad hoc Group on COVID-19 and safe trade in 

8 FAO: Food and Agriculture Organization of the United Nations.

9 JAC: Joint Advisory Committee for Rinderpest

10 RHF: rinderpest holding facility

11 CIRAD: Centre de coopération internationale en recherche agronomique pour le développement (Agricultural Research for 

Development).

12 FADDL: Foreign Animal Disease Diagnostic Laboratory.

13 PIADC: Plum Island Animal Disease Center

14 IVDC: National Institute for Viral Disease Control and Prevention

15 RVCM: rinderpest virus containing materials
18 Biological Standards Commission/February 2021

animals and animal products that was considering the risk to human health posed by international trade 

in mink pelts. In response to the reported outbreaks in mink, the OIE developed Guidelines for working

with farmed animals of species susceptible to infection with SARS-CoV-2 and has formed a joint OIE

and FAO advisory group on viral evolution of SARS-CoV-2 in animals.

In December 2020, the OIE hosted two global webinars for OIE Delegates, OIE Laboratories Focal

Points and key partners to share experiences on the impact of COVID-19 on veterinary laboratories and

to identify challenges, innovations and opportunities that arose during the pandemic. Presentations were

given by OIE Members to demonstrate how veterinary laboratories were able to support the public health

response to COVID-19 by testing human specimens for SARs-CoV-2, both at the individual laboratory

level and through a network of laboratories. The interactive discussions focused on strengthening the

One Health Concept and what lessons have been identified from the pandemic from which we can learn

for the future both for animal and public health emergencies. The OIE is currently consolidating the

outputs of the webinars into a report and a short policy brief to share with the participants and the OIE’s

network. The report and summary policy brief will be used to inform the OIE Sustainable Laboratories

initiative and other capacity building work of the OIE and to continue to advocate for the inclusion of

Veterinary Services in whole-of-government frameworks for emergencies and disasters.

Lastly, the OIE is continuing to work on a future programme called the OIE Wildlife Health Management

Framework which aims to anticipate, reduce, and manage risk of spill over events of pathogens between

wildlife, livestock, and humans at the animal/human/environment interface.

10.4. Global Laboratory Leadership Programme

Historically, the OIE has provided workforce development opportunities to National Focal Points for

Veterinary Laboratories in the form of regional seminars. To enhance and extend the OIE’s training

offering for laboratory systems leaders, the OIE partnered with WHO to found the GLLP16, in

collaboration with the CDC17, the APHL18, the ECDC19 and FAO.

The GLLP Partnership will enable the OIE to provide a more comprehensive laboratory systems

workforce development offering to Veterinary Services’ stakeholders and to expand access for

Veterinary Services staff. GLLP will complement existing face-to-face training and provide access to

virtual training through the OIE’s Training Portal. The aim of the OIE’s involvement in this partnership

is to ensure that animal health laboratory leaders can benefit from laboratory leadership training, that

their context and needs are included and addressed, and that they have access to training materials, both

through the OIE Training Portal and through WHO’s Health Security Learning Platform.

To support the application of the GLLP’s Laboratory Leaders Competency Framework, in 2020 the OIE

mobilised the expertise of more than 40 OIE experts representing all 5 OIE Regions, from more than

eight OIE Reference Centres, the OIE Biological Standards Commission, and OIE Partner WAVLD.

These experts supported the development of the GLLP Learning Package materials (three Sections

(Laboratory Management, Laboratory Leadership, and Laboratory Systems), nine units and 42 modules).

All material has a strong One Health focus. The modules are focused on laboratory surveillance, outbreak

investigation, preparedness, response, recovery, biosafety, biosecurity, shipment of dangerous goods,

laboratory systems, leadership, communication, and management. The GLLP Learning Package

materials will be available in 2021. Materials include instructor’s guides, participant’s guides, slide

decks, programme implementation guide and mentoring guide in both face-to-face and virtual learning

formats, targeted at health laboratory system management and leadership.

16 GLLP: Global Laboratory Leadership Programme

17 CDC: Centers for Disease Control and Prevention (United States of America)

18 APHL: Association of Public Health Laboratories (United States of America)

19 ECDC: European Centre for Disease Prevention and Control
Biological Standards Commission/February 2021 19

10.5. Sustainable laboratories data analysis and advocacy paper

With the generous support of Global Affairs Canada, the OIE is undertaking a project to address

laboratory biosafety and biosecurity, innovation, and resource sustainability to reduce biological threats.

The OIE is analysing PVS Pathway data to inform a position paper on the investment needs for

sustainable laboratories, and will hold a technical consultation to establish the research agenda for

evidence-based biosafety in low-resource settings. The OIE is expanding the PVS Sustainable

Laboratories toolbox with economic and laboratory management expertise, supporting Laboratory

Twinning Projects, and exploring open innovation as an approach to addressing laboratory sustainability

challenges. Specific information on the biosafety research roadmap, the open innovation, and laboratory

twinning is available in dedicated sections of this report.

Under this project, economic and laboratory management experts are advising the OIE on the internal

validity of the PVS Sustainable Laboratory Tool, analysing data collected through the past PVS

Sustainable Laboratories missions and will develop a position paper on Investment Needs for Sustainable

Laboratories. To date, a detailed assessment of the current tool’s calculations and formulae to provide an

evidence-based review of the internal validity of the model has been completed; a guide on how

laboratories can demonstrate value to their clients by highlighting benefit streams for the private sector,

government, research partners, and donors according to the different functions a laboratory may serve at

national, regional, and international levels, and economic analysis tools that can be used for these clients

have been developed; and a literature review and expert consultation to inform the choice of indicators

and identify data gaps has been undertaken. The next steps of the project are:

• Development of a proposal for future sustainability analysis

• Construction of models using the pre-existing data and missing parameters

• Arguments developed on the value of the laboratory expressed beyond being a service provider to the

veterinary services and sustainability can be expressed in a form beyond an investment appraisal or

currency amount

• Development of a position paper detailing the specific investment needs for laboratories and

laboratory networks. Topics may include:

o challenges for sustainability as revealed through analysis of past PVS Laboratory Missions

o additional KPIs and other metrics necessary to evaluate laboratory sustainability

o best practices to ensure consistent and high-quality outputs from revised tools and PVS mission

methodology

o case studies of how strategic and operational considerations contribute to “successful” and

sustainable laboratories

o recommendations for implementing the OIE’s suite of tools in the real-world context of existing

laboratories.

Given the challenges related to in-person missions and meetings during the COVID-19 pandemic, many

activities of the project are unable to be implemented as planned. To innovate and find solutions during

this challenging time, the OIE is developing the online PVS Sustainable Laboratories Tool where data

entry, calculations, visualisations, and tools are available through an online portal and database. A virtual

tool through an online portal will provide improved access to the inputs and outputs of the PVS

Sustainable Laboratories missions and increase access for end users in remote areas or in areas that are

difficult access for security, geographical, physical, or health-related reasons.
20 Biological Standards Commission/February 2021

10.6. VICH: Brief report on the 39th VICH Steering Committee Meeting and 13th VICH Outreach

Forum meeting (16–19 November 2020)

The Commission was updated on the 39th VICH Steering Committee and the 13th VICH Outreach Forum 

(VOF), which took place electronically from 16 to 19 November 2020. 

The 13th meeting of the VOF, chaired by the OIE, drew over 90 participants representing 22 national 

regulatory agencies and animal health industry organisations. Following updates on VICH activities and 

related OIE activities, the VOF members took advantage of an open Q&A session. An online training 

webinar organised with the aim of better understanding of VICH Guideline 27 (Antimicrobial Resistance 

– Guidance on pre-approval information for registration of new veterinary medicinal products for food 

producing animals with respect to antimicrobial resistance) was held electronically for VOF members 

on 9 February 2021.

The Commission was informed that that the VICH Steering Committee adopted VICH Guideline GL59 

(Biologicals) LABST – Harmonisation of criteria to waive laboratory animal batch safety testing for 

vaccines for veterinary use for implementation in VICH Members by November 2021. This Guideline 

completes the series of three VICH Biologicals Guidelines on harmonising criteria to waive target and 

laboratory animal batch safety testing, with the aim of reducing the need for these tests and improving 

animal welfare. 

In addition, the Commission was informed that the document VICH’s priorities for its 5th phase (2021 

– 2025), concerning VICH’s next strategy, was adopted. The document underlines the importance to 

foster effective cooperation with the OIE, particularly with regard to the OIE’s strategic focus on 

promoting good governance of veterinary medicinal products for OIE Members with the possibility to 

apply the harmonised technical requirements established in VICH Guidelines. 

The 40th Steering Committee meeting is planned for 15 to 18 November 2021 in the offices of the 

European Medicines Agency (EMA) in Amsterdam.

10.7. Biosafety research road map

The Group, which is linked to the sustainable laboratories project, was convened to look at all aspects of

biosafety to improve understanding and to identify the gaps in the knowledge on biosafety issues. To 

begin, the Group selected ten organisms and looked into activities that are typically undertaken with 

these organisms in laboratories to try to understand the biosafety precautions used and if there is any 

scientific basis for these precautions. The Group divided it into four subgroups: one Group focused on 

respiratory pathogens, one on zoonoses, one on viral haemorrhagic fevers, and the other on miscellaneous

diseases and pathogens. A consultant has been hired to research the literature and gather baseline 

information on each organism. Each subgroup will look at two or three organisms in each category to

focus on any gaps in the literature and identify the processes associated with each organism that might 

generate biosafety risks. This process is ongoing and the group continues to communicate offline.

10.8. Update on IAEA20 Zodiac21 Project

The Zodiac project is an IAEA initiative to establish a comprehensive, multisectoral and 

multidisciplinary approach to the timely detection of zoonotic diseases and prevention of their spread. 

The aim is to strengthen the ability of the IAEA and key partner organisations to support Member States 

in preparing for, and responding to, outbreaks of zoonotic diseases.

The Commission was briefed on discussions between the OIE, FAO, and WHO through the Tripartite 

Secretariat mechanism and between IAEA and OIE directly. The OIE acted on the Commission’s 

recommendation to ensure significant consultation at the strategic level through several meetings with 

IAEA, WHO, and FAO. IAEA has approached OIE to inform that following approval at the Board of 

Governors meeting in November 2020, IAEA had begun to implement the Zodiac Project. IAEA also 

wishes to establish an MOU with the OIE to cooperate “to better support countries through our respective 

programmes and to achieve synergy including in the implementation of the Zodiac Project.” The OIE 

would aim through the development of the MOU to better understand the scope of the project so that 

20 IAEA: International Atomic Energy Agency

21 ZODIAC: Zoonotic Disease Integrated Action
Biological Standards Commission/February 2021 21

further discussions can be held at the operational and technical levels to avoid duplication, maximise the 

efficiency of resource management and ensure sustainability. The areas of overlap with OIE activities 

and other international players’ activities and mandates highlighted by the Commission in Sept 2020 

remain in the Zodiac proposal. The MOU proposal made by IAEA will be examined in 2021.

10.9. Ad hoc Group on alternative strategies for the control and elimination of Mycobacterium

tuberculosis complex infection in livestock

The meeting of the OIE ad hoc Group on Alternative Strategies for the Control and Elimination of

Mycobacterium tuberculosis complex Infection in Livestock was held via videoconference on

29 September 2020.

The ad hoc Group was convened to:

• Consider and address three of the ten priorities set out in the Roadmap for Zoonotic Tuberculosis22.

The three priorities are: i) the need to reduce the TB prevalence in livestock; ii) the development of

policies and guidelines for surveillance and control of TB in animals; and iii) the implementation

of community-based interventions to reduce burden of TB in humans and livestock, recognizing

the cultural and socioeconomic realities of each setting;

• Explore and recommend actionable strategies to control TB in livestock other than by test and

slaughter.

Keys issues and outcomes of the meeting

• The Group noted that wildlife was not considered along with livestock as a target animal population

of TB control strategies in the ToR, and acknowledged that the control of TB in wildlife requires a

set of measures different from those in livestock. To keep the scope of work narrow and avoid

adding complexity, the Group agreed to not include wildlife in the ToR.

• The Group agreed that there is a need to develop innovative strategies for controlling TB in

livestock in economically disadvantaged areas where slaughter is not an option and the zTB burden

in humans is unacceptably high. However, the Group noted that another key challenge to be

addressed in these areas is the lack of expertise and technical capacity, and suggested also

considering ways to improve the efficient use of existing tools by the Veterinary Services rather

than focusing solely on innovation. It also acknowledged that ‘one size does not fit all’ and that

selected TB control strategies would need to be flexible and adaptable to the changing conditions

of real-world scenarios.

• The Group agreed to clarify that these TB control strategies can also refer to locally applicable

interventions (i.e. at herd level) that may be scaled up to cover larger areas while taking into account

the relevant socioeconomic and cultural settings.

• The Group recognised that one of the critical tasks of this initiative is to elicit expert opinion on TB

control strategies by means of interviews with external experts other than ad hoc Group members.

The Group reviewed a draft list of questions for expert elicitation, and finalised a first tranche of

external experts to be interviewed.

A formal survey tool is being developed. Interviews with external experts will be conducted during 2021.

22 The Roadmap for Zoonotic Tuberculosis is a multisectoral roadmap that details ten priorities for addressing zoonotic 

tuberculosis in people and animals. It has jointly been developed by WHO, OIE, FAO and the International Union Against 

Tuberculosis and Lung Disease (Union).
22 Biological Standards Commission/February 2021

A follow-up ad hoc Group meeting is planned in 2021 to discuss the results of the survey and formulate

recommendations on new control strategies to control TB in livestock.

11. Any Other Business

11.1. Work plan

The updated work plan was agreed and can be found at Annex 3.

11.2. Dates of the next Biological Standards Commission meeting

The Commission noted the dates for its next meeting: 6–9 September 2021.

_______________

.../Annexes
Biological Standards Commission/February 2021 23

Annex 1

MEETING OF THE OIE BIOLOGICAL STANDARDS COMMISSION

Paris, 8–9, 11–12 February 2021

__________

List of participants

MEMBERS

Prof. Emmanuel Couacy-Hymann

(President)

Professor of Virology, Central

Laboratory for Animal Diseases

(LANADA/CLAD)

BP 206 Bingerville

CÔTE D’IVOIRE

chymann@gmail.com

Prof. Ann Cullinane

(Member)

Head of the Virology Unit

Irish Equine Centre

Johnstown

Naas

Co. Kildare

IRELAND

ACullinane@irishequinecentre.ie

Dr Franck Berthe

(Vice-President)

Senior Livestock Specialist, Food and

Agriculture Global Practice, World

Bank, 1818 H Street NW, Washington,

DC 20433

UNITED STATES OF AMERICA

fberthe1@worldbank.org

Dra. Ana Maria Nicola

(Member)

Head, Brucellosis Department

(OIE/FAO Laboratory/Reference

Center), General Directorate of

Laboratories and Technical Control,

National Service of Agri-Food Health

and Quality (SENASA), Talcahuano

1660, CP1640 Martínez, Buenos Aires

ARGENTINA

anicola@senasa.gob.ar

nicolaana@hotmail.com

Dr John Pasick

(Vice-President)

Formerly Canadian Food Inspection

Agency, National Centre for Foreign

Animal Disease, 1015 Arlington Street

Winnipeg, Manitoba R3E 3M4

CANADA

jmpasic55@gmail.com

Dr Joseph S. O’Keefe

(Member)

Head, Animal Health Laboratory,

Ministry for Primary Industries,

P.O. Box 40-742

Upper Hutt, 5140

NEW ZEALAND

Joseph.O’Keefe@mpi.govt.nz

okeefej@mpi.govt.nz

CONSULTANT EDITOR OF THE TERRESTRIAL MANUAL

Prof. Steven Edwards

c/o OIE 12 rue de Prony

75017 Paris

FRANCE

steve@cabanas.waitrose.com

OIE HEADQUARTERS

Dr Gregorio Torres

Head, OIE Science Department

g.torres@oie.int

Ms Sara Linnane

Scientific Officer – International 

Standards, OIE Science Department

s.linnane@oie.int

Dr Gounalan Pavade

Scientific Coordinator, OIE Science

Department

g.pavade@oie.int

_______________

25 Biological Standards Commission/February 2021

Annex 2

MEETING OF THE OIE BIOLOGICAL STANDARDS COMMISSION

Paris, 8–9, 11–12 February 2021

__________

Agenda

1. Welcome 

2. Adoption of Agenda

3. Manual of Diagnostic Tests and Vaccines for Terrestrial Animals

3.1. Review of Member comments received on draft chapters and their endorsement for circulation for second-round 

comment and proposal for adoption in May 2021

3.2. Request to include instructional training videos in Terrestrial Manual chapters

3.3. Review of the instructions for authors

3.4. Update from February 2018 meeting: review of a validation dossier for a quantitative real-time polymerase chain 

reaction method for detection of Taylorella equigenitalis directly from swabs

3.5. Terrestrial Manual status: update on chapters selected for the 2021/2022 review cycle

4. OIE Reference Centres 

4.1. Annual reports of Reference Centre activities in 2020

4.2. Applications for OIE Reference Centre status

4.3. Changes of experts at OIE Reference Centres

4.4. Review of new and pending applications for laboratory twinning

4.5. Follow-up on the consultation with the Council

Reference Laboratories – Implementation of the SOPs

4.6. Follow-up September meeting: further feedback from the Laboratories that are not complying with the key ToR 

according to their 2018 annual report

4.7. Feedback from the Laboratories that are not complying with the key ToR according to 2019 annual report

4.8. Annual report for Reference Laboratories for Rinderpest: adapted template

4.9. Further develop the SOPs to include provisions for suspending laboratories and for laboratories temporarily with no 

expert

Collaborating Centres – Implementation of the SOPs

4.10. Postponed from September: feedback on the mapping exercise for the existing Centres against the list of main focus 

area and specialties

4.11. Follow-up September: feedback from the Centres that are not complying with the key ToR according to 2019 annual 

report

4.12. Follow-up September: feedback on the review of the 5-year work plans received from Collaborating Centres

5. Ad hoc Groups

Update on activities of ad hoc Groups

5.1. Ad hoc Group on Replacement of the International Standard Bovine Tuberculin (ISBT) and revision of the OIE 

Terrestrial Manual Chapter 3.4.6 Bovine tuberculosis

5.2. Expert consultation to review the OIE Terrestrial Manual chapter 3.4.6 Bovine tuberculosis

5.3. Ad hoc Group on Sustainable Laboratories, 11 December 2020

5.4. Ad hoc Group on the revision of Terrestrial Code chapters regarding the collection and processing of semen of 

animals, 9 November 2020 to 15 January 2021
26 Biological Standards Commission/February 2021

6. International Standardisation/Harmonisation

6.1. OIE Register of diagnostic kits

6.1.1. Update and review of new or renewed applications

6.1.2. Endorsement of updated SOP for OIE Register of diagnostic kits

7. Resolutions for the General Session

7.1. Resolutions that will be presented in May 2021

8. Conferences, Workshops, Meetings

Future Conferences, Workshops, Meetings 

8.1. WAVLD International Symposium, Lyon, France 2023

9. Liaison with other Commissions

9.1. Horizontal issues among the Specialist Commissions

9.1.1. Update on case definitions

9.1.2. SOP for determining if a pathogenic agent of terrestrial animals meets the OIE definition for an emerging 

disease

9.2. Scientific Commission for Animal Diseases

9.2.1. Feedback on review of Collaborating Centre application on Economics of Animal Health

9.3. Terrestrial Animal Health Standards Commission

9.3.1. Updates from the September 2020 Code Commission meeting

9.3.2. Questions on Chapter 12.7 Infection with Theileria equi and Babesia caballi (equine piroplasmosis)

9.3.3. Question on Chapter 8.3 Infection with bluetongue virus

9.3.4. Question on Chapter 11.10 Infection with Theileria annulata, T. orientalis and T. parva

9.3.5. Question on Chapter 10.4 Infection with high pathogenicity avian influenza viruses

9.3.6. Question on Chapter 12.2 Infection with Taylorella equigenitalis (contagious equine metritis)

9.4. Aquatic Animal Health Standards Commission

9.4.1. Feedback on review of Collaborating Centre application on Economics of Animal Health

10. Matters of Interest for Consideration or Information

10.1. Update on OFFLU

10.2. Update on rinderpest 

10.3. Update on COVID-19

10.4. Global Laboratory Leadership Programme

10.5. Sustainable laboratories data analysis and advocacy paper

10.6. VICH: Brief report on the 39th VICH Steering Committee Meeting and 13th VICH Outreach Forum meeting (16–

19 November 2020)

10.7. Biosafety research road map

10.8. Update on IAEA Zodiac Project

10.9. Ad hoc Group on alternative strategies for the control and elimination of Mycobacterium tuberculosis complex 

infection in livestock

11 Any Other Business

11.1. Work plan 

11.2. Dates of the next Biological Standards Commission meeting

______________
27 Biological Standards Commission/February 2021

Annex 3

Work Programme for the OIE Biological Standards Commission

Subject Issue Status and Action

Updating the 

Terrestrial Manual

1) Circulate the chapters approved by the BSC to Member Countries 

for second-round comment February/March 2021

2) Remind authors of the chapters identified previously for update but 

not yet received and invite authors of chapters newly identified for 

update

On-going

3) Convene virtual expert consultation to update chapter 1.1.4 on 

biosafety/biosecurity April 2021

4) Continual communication with Working Group on Wildlife to identify 

needs for specific diagnosis of wildlife diseases Ongoing

Consultation with the 

Council on Reference 

Centres

1) Inform the Aquatic Animals Commission of the consultation with the 

Council and outcome for feedback before implementation of the 

recommendations (appointment of Reference Laboratory experts; 

applications from the private sector; lack of testing of international 

samples)

September 2021

Collaborating Centres

1) Implementation of the adopted SOPs:

a) identify “miscategorised” Collaborating Centres and write to them to 

resolve the situation. March 2021

b) review new “map” that has resulted from the mapping exercise September 2021

c) send feedback to those Centres that need to complete or submit their

5-year work plans March 2021

2) Send feedback to Centres re: review of annual reports for 2018 and 

2019 March 2021

3) In-depth review of all annual reports for activities in 2020 based on 

the performance criteria to identify any that are not complying April–July for September 2021

Reference Laboratories

1) Send feedback to labs re: review of annual reports for 2018 and 

2019 March 2021

2) In-depth review of all annual reports for activities in 2020 based on 

the performance criteria to identify any that are not complying April–July for September 2021

4) Seek the opinion of the Aquatic Animals Commission on the 

proposed amendments to the SOPs for Reference Laboratories re: 

provisions for suspending laboratories and for laboratories 

temporarily with no expert

September 2021

Reference Centre Networks

1) Follow up with the three newly launched Reference Laboratory 

networks (ASF, PPR and rabies) On-going
Annex 3 (contd) Work Programme for the OIE Biological Standards Commission

28 Biological Standards Commission/February 2021

Subject Issue Status and Action

Standardisation/

Harmonisation

1) Project to extend the list of OIE approved reference reagents On-going

2) Update two of the existing guidelines, and include the template as 

an annex for the data to be submitted with a request for approval to 

be added to the list of approved reagents

For September 2021

3) Project to develop Replacement International Standard Bovine 

Tuberculin: finalise report and propose for adoption For September 2021

Ad hoc Groups

1) Ad hoc Group on Sustainable Laboratories First semester 2021

2) Ad hoc Group on the revision of Terrestrial Code chapters 

regarding the collection and processing of semen of animals

Final report for September 

2021

Projects

1) Veterinary Biobanking (project) Ongoing 

2) High Throughput Sequencing and Bioinformatics and 

Computational Genomics (HTS-BCG) On hold awaiting funding

Conferences, Workshops 

and Meetings with 

participation by BSC 

Members

1) Biosafety research roadmap Ongoing

2) WAVLD OIE seminar: theme and programme and speakers June 2023

Covid-19 Engage with changes associated with post-pandemic reviews On-going

Performance Engaging with the ongoing processes around performance issues with 

Reference Labs On-going

Twinning Programme Assess the status of the post-twinning labs: dashboard. Gather 

feedback from the labs, way forward. Review geographical distribution September 2021

Develop laboratory 

standards for emerging 

diseases

1) Discuss the Terrestrial Code chapter once adopted with the aim of 

introducing a corresponding chapter for the Terrestrial Manual After May 2022

__________
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