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88 SG/12/CS2 A

Original: English

February 2021

REPORT OF THE MEETING OF THE OIE BIOLOGICAL STANDARDS COMMISSION

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

PART A – Texts to be proposed for adoption in May 2021

_______

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 this 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 (herewith) 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 (to be published in April 2021),

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.

1. Welcome

Dr Matthew Stone, Deputy Director General (International Standards and Science) welcomed the Biological

Standards Commission (the Commission), noting that this was the last meeting in the 3-year term, a term during 

which excellent productive output has been maintained despite significant challenges. Dr Stone recognised that 

the OIE has drawn heavily on the Specialist Commissions as it responded to the COVID-19 pandemic, and the 

response has always been in the spirit of goodwill, innovation and scientific excellence. Dr Stone thanked all 

members for their contributions during the term, including the forthcoming meeting, and extended this 

appreciation to the members’ employing institutions and national governments. Dr Stone briefed the members 

on the ongoing design process for a full-virtual OIE General Session. He summarised the ongoing work on the 

OIE standards development and review system, including Standard Operating Procedures development and 

planning for digital tools. Finally, he provided an overview of the OIE’s continuing support to the COVID-19 

pandemic response, including ad hoc Groups, the development and implementation of the OIE Wildlife Health 

Management Framework and the compilation of services under the OIE Supporting Veterinary Services 

Resilience paper.
2 Biological Standards Commission/February 2021

2. Adoption of Agenda

The proposed agenda was presented and adopted. The Agenda can be found at Annex 2.

3. Manual of Diagnostic Tests and Vaccines for Terrestrial Animals

For this Agenda Item, the Commission was joined by Dr Steven Edwards, Consultant Editor of the OIE Manual

of Diagnostic Tests and Vaccines for Terrestrial Animals (Terrestrial Manual).

3.3. Review of Member comments received on draft chapters and their endorsement for circulation for

second-round comment and proposal for adoption in May 2021

Following Member comments that the terminology in Chapter 3.1.6 infection with Echinococcus 

granulosus and with E. multilocularis should be aligned with terms proposed by a WHO1expert group,

and that the vaccine section should be expanded using the Terrestrial Manual vaccine section template, 

the Commission decided to put this chapter on hold and to request the OIE Reference Laboratory to

address these comments with assistance from the WHO experts.

The Commission reviewed the comments that had been received on the 15 draft chapters that had been 

sent for first-round Member comment in October 2020. The Commission approved 14 for circulation, 

some subject to clarification of certain points by the experts, before presenting them for adoption by the 

Assembly in May 2021. At the 88th General Session in May 2021, these 14 chapters and the 24 chapters 

postponed in 2020, will all be proposed for adoption.

Comments had been received from: Australia, Canada, China (People’s Rep. of), European Union, New 

Zealand, Switzerland.

The 14 chapters and a summary of the main amendments made in response to Member comments are

provided below:

1.1.1. Management of veterinary diagnostic laboratories: added a sentence in Section A.1 General 

considerations on the support that veterinary laboratories can bring to national laboratory 

capacity during major human health events; amended text in Section A.2. Accountability and 

oversight to better reflect funding practices in national reference laboratories; in Section A.6.1 

Health and safety added a specific recommendation to protect workers from chemicals, and a 

statement that training staff is key to avoiding accidents; expanded the title of Section A.6.2 

Biosecurity to include biosafety and clarified the text on confidentiality requirements; deleted 

reference to ISO 9001 from Section B.3 Research; amended the title of Section B.4. Disease

surveillance to Information and data for disease surveillance and updated the text 

accordingly; deleted sentences from Section C.3 Finance that were too prescriptive and 

focused on one specific way of running a laboratory.

3.1.3. Bluetongue (infection with bluetongue virus): in the summary, replaced “various other 

Artiodactyla” with “camelids” to clarify the species affected by bluetongue; deleted a sentence 

from the summary and introduction on the economic impact of the disease and trade 

restrictions as this text is beyond the scope of the Terrestrial Manual; deleted mention in the 

summary that the agar gel immunodiffusion test is one of the most frequently used serological 

tests; deleted the words “in Europe” from text referring to a higher incidence of clinical disease 

in cattle infected by serotype 8 as similar behaviour has been demonstrated with serotype 8 in 

North Africa and the Middle East; rejected a proposal to include a statement in Section A.1 

Description of the disease on which serotypes are listed for intervention in one region as it is 

too area specific and disease notification is not covered in the Terrestrial Manual; in Table 1. 

Test methods available and their purpose, amended the ranking of the virus neutralisation test 

1 WHO: World Health Organization
Biological Standards Commission/February 2021 3

for the purpose “Individual animal freedom from infection prior to movement” because 

antibodies to all 27 serotypes would need to be tested to qualify an animal free from infection 

prior to movement, which is not practical; in Section B.1.3.1 Real-time RT-PCR2 deleted the 

proposed amendments to the protocol so that the original method remains unchanged; in 

Section 2.4 Agar gel immunodiffusion explained what is meant by “problem samples”.

3.1.12. Leptospirosis: regarding Leptospira taxonomy, added a reference and a hyperlink in the 

introduction to the latest information on strains, serovars, serogroups and species; in Table 1.

Test methods available and their purpose, purpose “Contribute to eradication policies”,

amended the rating of isolation and identification [of leptospires] as it is difficult and time 

consuming, and for the purpose “Immune status in individual animals or populations postvaccination” amended the rating of the MAT3

as it is not suitable post-vaccination because it 

is not specific to a serovar, cannot differentiate between vaccinates and infected individuals, 

lacks sensitivity for vaccination induced antibodies and is transient, and removed the footnote 

that stated that isolation and typing should be carried out only on those animals that have 

positive serology because strains have been isolated from serologically negative animals; in 

Section A.1.1 Isolation of Leptospira added text that the diagnostic sensitivity of isolation is 

low but that having the strain provides important epidemiological information; rejected a 

request to reinstate a number of references: the Commission reminded Members that the 

Terrestrial Manual is not intended to provide comprehensive reviews of the literature, but 

rather to provide key, up-to-date references as an entry point to the literature for those who 

wish to study further – the Commission aims to limit the number of references in each chapter 

to a maximum of 30; rejected a proposal to change the temperature range for cultivation of 

cultures because no reference was provided; in the description of the MAT, the Commission 

rejected a request to identify counting leptospires in a counting chamber as the gold standard

because it is only part of the procedure and the term “gold standard” is not used the Terrestrial 

Manual.

3.1.23. Vesicular stomatitis: harmonised the nomenclature and abbreviations used for the viruses 

causing vesicular stomatitis, and deleted mention of serotype throughout the chapter; removed 

mention of WAHIS from the summary and introduction because, as the disease is no longer 

listed, WAHIS is not a reliable source of current data; added Senecavirus A to Section B.1.1 

Direct visualisation for differential consideration as outbreaks have been reported in regions 

that also experience VS outbreaks; made technical amendments to the test protocol in Section 

B.1.2 Virus isolation in cell culture; in Section B.1.6 Real-time RT-PCR detection and typing, 

amended the name and some of the sequences given in Table 2. Oligonucleotides target for 

real-time RT-PCR of VSV; made technical amendments to the test protocol in Section B.2.3 

Virus neutralisation. 

3.2.7. Varroosis of honey disease (infestation of honey bees with Varroa spp.): replaced the word 

“phoretic” with “dispersal phase” throughout the chapter as the latter is the correct term; added 

an arrow to Figure 2b to point out the location of the Varroa mite on a bee specimen; added a 

sentence in the introduction clarifying that for the purpose of the Terrestrial Manual, varroosis 

is linked to the detection of Varroa spp., regardless of the occurrence of clinical signs; did not 

agree to a request for clarification of a statement that deformed wing virus is well adapted to 

the life cycle of the Varroa mite because the statement is followed by a literature reference

that would provide the information sought; replaced one of the photographs in Section B. 

Diagnostic techniques as it better illustrates the dorsal aspect of a female V. destructor.

2 RT-PCR: reverse-transcription polymerase chain reaction

3 MAT: microscopic agglutination test
4 Biological Standards Commission/February 2021

3.3.4. Avian influenza (including infection with highly pathogenic avian influenza viruses): agreed

to leave the title of the chapter unchanged as Terrestrial Manual chapters are titled by disease 

name (avian influenza) and in parenthesis the title of the corresponding revised chapter in the 

Terrestrial Code, which is the name of the infection; added a sentence regarding zoonotic 

potential of avian influenza viruses in the introduction; revised the texts to harmonise the 

information on sampling and initial testing in both the avian influenza and Newcastle disease 

chapters so that they are identical; deleted the information on notification obligations for the 

disease and inserted a reference to the Terrestrial Code chapter; elaborated the information to 

clearly state that the presence of multiple basic amino acids at the cleavage site remains the 

genotypic standard for designating high pathogenicity; removed references to specific 

biosafety containment levels from the chapter as these should be determined by biological risk 

analysis; made a number of editorial changes to address various comments on different 

sections of the chapter.

3.3.14. Newcastle disease (infection with Newcastle disease virus): amended the taxonomy 

throughout the chapter based on several Member comments and reverted to the use of virus 

names and not species – therefore, the term “avian paramyxovirus” has been used and a 

statement has been included in the introduction to reflect the new nomenclature; revised the 

texts to harmonise the information on sampling and initial testing in both the avian influenza 

and Newcastle disease chapters so that they are identical; deleted the information on 

notification obligations for the disease and inserted a reference to the Terrestrial Code chapter; 

made other editorial changes as received.

3.4.4. Bovine genital campylobacteriosis: did not agree to add a sentence and reference to Section B 

Diagnostic techniques referring to a genomic island that can be used to discriminate 

Campylobacter fetus subsp. venerealis from C. fetus subsp. fetus as the experts published a 

paper showing that this island can also be present in C. fetus subspecies fetus strains; added 

text to Section B.1.9 Molecular identification of Campylobacter fetus subspecies clarifying 

that PCR is not recommended for primary diagnosis, but that it is possible to perform it from 

Thomann’s transport and enrichment medium after enrichment; did not accept a proposal to 

add a new PCR and a reference to Table 3 Sensitivity and specificity of C. fetus (sub)species 

identification of PCR assays as only two C. hyointestinalis strains, the strain that cross reacts 

the most with C. fetus, had been tested; added text to Section B.2 Serological tests – antibody 

detection that the ELISA4is not considered validated; a significant Member comment on role 

and identification of C. fetus ssp. venerealis biovar intermedius (Cfvi) and on the methods of 

identification used for the C. fetus group will be addressed when the chapter is next updated.

3.5.3. Infection with Trypanosoma equiperdum (dourine in horses): did not agree to delete evidence 

of sexual transmission from the paragraph in the summary on definitive diagnosis as it is 

consistent with the rest of the chapter; added text to Section A Introduction clarifying that 

though nagana, surra and dourine all may present with similar chronic clinical signs, dourine 

initially often presents with the venereal clinical signs that progress to neurological and more 

chronic disease; deleted from the summary and from Section B.1.1 Overview of 

parasitological methods mention of diagnosis depending on evidence of sexual transmission 

as it is an epidemiological observation and not a test method; reinstated a sentence in Section 

B.1.1 on detection of trypanosomes in vaginal and urethral mucus samples as it provides 

important timing details that need to be considered in sample collection to improve testing 

sensitivity; in section B.2.1.1.2 Antigen preparation from in-vivo propagated parasites, 

replaced “trypanosome bodies” with “trypanosomes”; in Section B.2.4 Other serological tests, 

did not agree to reinstate traditional tests, such as radioimmunoassay, agar gel 

immunodiffusion and card agglutination, as they are not fit for purpose; deleted Section B.3 

Confirmation of dourine cases as case definitions should be included in the Terrestrial Code

rather than the Terrestrial Manual.

4 ELISA: enzyme-linked immunosorbent assay
Biological Standards Commission/February 2021 5

3.5.5. Equine encephalomyelitis (Eastern, Western and Venezuelan): replaced the term “Old World” 

with a region-specific description; rejected a proposal that the effect of climate change on the 

vector populations and thus on the prevalence and distribution of mosquito-borne diseases 

should also be covered in this chapter because climate changes is beyond the scope of the 

Terrestrial Manual, which focuses on diagnosis; deleted information on Old World 

alphaviruses as it is not relevant for this chapter about equine encephalomyelitis; added a 

sentence and a reference on the potential transmission of Eastern equine encephalomyelitis 

virus (EEEV) from horses with a transient EEE viraemia to mosquitoes, which could allow 

them to play a role in ongoing transmission; in Section B.1.1 In-vitro and in-vivo culture

deleted text on the use of newly hatched chickens for virus isolation; in Section B.1.2.2 Realtime reverse-transcription PCR, Table 3, added primer/probe sequences for Venezuelan

equine encephalomyelitis along with a reference; in Section B.2.1 Complement fixation, added 

a sentence that the effectiveness of the antigen inactivation treatment should be confirmed 

before working with the antigen.

3.6.1. Myxomatosis: amended the name of the Shope fibroma virus to rabbit fibroma virus, 

throughout the chapter, which is approved by the International Committee on Taxonomy of 

Viruses; added a sentence and references to the introduction on the new genetic variant of 

Myxoma virus isolated from the European brown and Iberian hares; updated Section B.1.6 

Molecular methods – detection of nucleic acid to include a real-time PCR; in Section C

Requirements for vaccines, added a sentence and a reference to a licensed novel trivalent 

recombinant attenuated vaccine.

3.8.6. Porcine reproductive and respiratory syndrome (PRRS): included text on evidence that highly 

pathogenic strains of PRRS virus are also able to infect endothelial cells in lung, heart and 

brain, an attribute that may be of value in characterising new strains; added real-time RT-PCR 

to the summary and to Table 1 Test methods available and their purpose as the test had already 

been included in Section B Diagnostic techniques; reinstated the immunohistochemistry 

method and in-situ hybridisation in Table 1 as such tests can also provide additional 

information on the pathogenesis of a particular strain; in Section B.1.3 Other methods added

text indicating that restriction fragment length polymorphism has been largely discredited as 

a reliable epidemiological tool for PRRS due to the highly error-prone nature of PRRSV 

replication; also in Section B.1.3 Other methods added text on the advantages and drawbacks 

of ORF5 sequencing, along with a protocol for an ORF5 PCR; in Section B.2 Serological tests

clarified the text on the limited diagnostic value of serological tests as results can be influenced 

by maternal antibodies or previous vaccination: to diagnose active infection in an individual 

animal, acute and convalescent serum samples can be tested to demonstrate seroconversion; 

in Section C2.1.1 Biological characteristics included the recommendation to determine the 

full genome sequence of the PRRS master seed virus and to use this reference sequence to 

control the genetic stability of the PRRS modified live virus during the production process or 

during the serial in-vivo passages; in Section C2.1.2 Quality criteria (sterility, purity, freedom 

from extraneous agents) added that the PCR might also be used, as a complement to culture, 

to detect extraneous virus that could be present in the PRRS master seed virus; in Section 

C.2.3.2 Efficacy requirement specified that the interference of maternally derived antibody 

with the efficacy of modified live vaccines needs to be evaluated.

3.9.6. Listeria monocytogenes: added hedgehogs to Table 1. Species with reported isolation of 

Listeria monocytogenes; in the introduction, added text on the presence of the bacterium in 

environmental niches, including soil, water and plants, and qualified that HACCP5as one food 

preparation method to reduce the risk of listeriosis in humans; deleted MALDI-TOF MS6from 

Table 1. Test methods available and their purpose as it is not a test method on its own but 

5 HACCP: hazard analysis critical control points

6 MALDI-TOF MS: matrix-assisted laser desorption ionisation–time of flight mass spectrometry
6 Biological Standards Commission/February 2021

rather an identification method for isolates; clarified the text in Section B.1.1. Bacterial 

isolation methods on the principles of the ISO 11290 Part 1 method; in Section B.1.2 Culturebased identification methods added information on the hybrid sub-lineage of the major lineage 

II (HSL-II) of L. monocytogenes; in Section B.1.6.1 Serotyping and genoserotyping (PCR 

group) amended the number of L. monocytogenes serovars to include a newly identified 

serovar and added text and a reference to a PCR method that can detect it; in Section C 

Requirements for vaccines, added text on safety concerns regarding the use of 

L. monocytogenes vectored vaccines in dogs.

3.9.11. Zoonoses transmissible from non-human primates: updated the reference to the Federation of 

European Laboratory Animal Science Associations; in Section 1. Tuberculosis, added a 

sentence clarifying that tuberculins prepared for use in humans are not of sufficient potency 

to elicit a response in non-human primates; in Section 4. Macacine herpesvirus 1 (Simian 

herpes B virus, Cercopithecine herpesvirus 1) clarified that PCR cannot identify latently 

infected macaques not actively shedding virus.

NB: All amendments made in response to Member comments are highlighted in yellow in the chapters. 

The chapters can be downloaded from the following address: 

http://web.oie.int/downld/Terr_Manual/MAILING_MARCH_2021.zip

Reminder: extract from the report of the September 2020 meeting of the Biological Standards 

Commission. The following 24 chapters are also proposed for adoption:

3.1. Review of comments received on chapters that would have been proposed for adoption in May

2020

As a result of the COVID-19 pandemic, the OIE Council decided, in agreement with the Director

General, that alternative procedures to address key institutional and administrative matters would be

instigated. As a consequence, no new or amended chapters for the Terrestrial Manual were proposed for

adoption in 2020. Chapters that were to be proposed for adoption in 2020 will be proposed for adoption

in May 2021. All relevant texts that were to be proposed for adoption in May 2020, which had been

circulated in the February 2020 report, were open for one additional round of comments. Only substantial

comments that had not been submitted before were considered. As stated in the February 2020 report,

texts (incorporating any revisions resulting from this process) will be circulated with the February 2021

report as the versions to be proposed for adoption in May 2021.

Comments had been received from: China (People’s Rep. of), Chinese Taipei, European Union, India,

New Zealand, Switzerland.

The Commission reviewed the comments and approved the chapters for proposal for adoption at the 88

th

General Session in May 2021. A summary of the main amendments are provided below:

2.1.2. Biotechnology in the diagnosis of infectious diseases: the advantages and strengths of

isothermal amplification were deleted from Section A.3 as they are described in the previous

two paragraphs; the Commission agreed that the techniques described in Section A.4.

Diagnosis by restriction fragment length polymorphisms (RFLP) and related DNA-based

approaches are not front-line diagnostic tools and so changed the title to “Analysis by

restriction fragment length polymorphisms (RFLP) and related DNA-based approaches”. In

Section C.5.1 Coxiella burnetii was added as the causative agent of Q fever.
Biological Standards Commission/February 2021 7

3.1.7. Epizootic haemorrhagic disease (infection with epizootic haemorrhagic disease virus): in the

summary, the number of non-structural proteins coded for by the EHD virus was changed

from “five” to “at least four”, and the time period post-exposure for antibodies to be detectable

was changed from “between 10 and 14 days” to “from 8 days”; still in the summary a request

to change serogroup-specific “RT-PCR” to “real-time RT-PCR” as one of the assays for

detection of EHD virus was rejected as “RT-PCR” covers both conventional and real-time

assays and the Commission did not want to limit the list to real-time RT-PCR; in Sections

B.1.2.1 and B.1.2.2, the target genes of the PCR methods described were corrected; a sentence

in Section C Requirements for vaccines was deleted as it referred to bluetongue and not EHD.

3.1.8. Foot and mouth disease (infection with foot and mouth disease virus) (Method of [vaccine]

manufacture only): no comments received.

3.1.10. Japanese encephalitis (vaccine section): one Member requested reinstatement of the mouse

inoculation test, but the Commission reconfirmed its removal as effective in-vitro methods

exist and the absence of a method from the Terrestrial Manual does not mean that it cannot

be used rather that it is not recommended by the OIE.

3.1.11. Leishmaniosis: minor editorial amendments to improve clarity; included a sentence and a

reference to LAMP7as an alternative method for genetic analysis; added text and a reference

to cross reactions found in dogs with Trypanosoma spp. using ELISA.

3.1.15. Paratuberculosis (Johne’s disease): in the summary reinstated microscopy as one of the

methods for confirming a diagnosis of paratuberculosis as faecal Ziehl–Neelsen staining is

included in Table 1 Test methods available for diagnosis of paratuberculosis and their

purpose; removed mention of the complement fixation test from the summary, and kept

mention of the agar gel immunodiffusion test clarifying that it remains a valuable test for the

detection of paratuberculosis in sheep; maintained deletion of the CFT from Table 1 but added

text to Section 2.2. explicitly stating that the CFT works well on clinically suspect animals,

but does not have sufficient specificity to enable its use in the general population for control

purposes. Thus, the CFT is not recommended for control purposes nor for individual animal

testing prior to international movement.

3.1.21. Trypanosoma evansi infection (surra in all species): added deer to the list of susceptible

species; added a sentence and a reference stating that Trypanosoma evansi was considered a

malignancy of T. brucei as this is an important characteristic of T. evansi; a proposal to delete

the formol gel test was not accepted as it is the method of choice for camels.

3.3.3. Avian infectious laryngotracheitis: one comment received regarding a typo.

3.3.5. Avian mycoplasmosis (M. gallisepticum, M. synoviae): In Section B. 1.3.2. 16s-rDNA-PCR

and denaturing gradient gel electrophoresis a sentence regarding the method’s suitability for

use on DNA extracts from clinical specimens has been reinstated.

3.4.2. Bovine babesiosis: minor editorial amendments to improve clarity; a request to add more upto-date molecular methods for detection of B. bovis and B. bigemina was put on hold as these

methods are not sufficiently validated.

3.4.5. Bovine spongiform encephalopathy: amended text reference to EU legislation and included a

hyperlink.

7 LAMP: loop-mediated isothermal amplification
8 Biological Standards Commission/February 2021

3.4.8. Contagious bovine pleuropneumonia (infection with Mycoplasma mycoides subsp. mycoides):

a suggestion to consult OIE WAHIS interface8for latest disease situation was included as the

Terrestrial Manual is not appropriate place to list the countries that are recognised by the OIE

as officially free of CBPP through adoption of an annual resolution.

3.4.10. Haemorrhagic septicaemia (Pasteurella multocida serotypes 6:b and 6:e): deleted Section

B.1.2.7 because antimicrobial sensitivity testing is not a serotyping method and is not used to

identify HS strains; made minor amendments to the PCR protocols.

3.4.12. Lumpy skin disease (LSD): a request to delete electron microscopy from Table 1 was not

accepted as the text reflects its deficiencies; deleted text in Section B.1.31 referring to PCRbased methods to distinguish between field and vaccine strains because emerging

recombinant vaccine strains may not be recognised using these methods.

3.4.16. Animal trypanosomes of African origin (excluding infection with Trypanosoma evansi and

T. equiperdum): the Commission noted that the taxonomy of Trypanosomes of African origin

remains controversial and acknowledged that some studies considered that T. evansi and T.

equiperdum evolved separately and therefore did not accept the proposal to consider T. evansi

and T. equiperdum as a subspecies of T. brucei; a request to add a sentence on the high

sensitivity and specificity of PCR methods was rejected as it applies to all PCRs and does not

need to be restated here; added text and a reference to an FAO publication regarding the

occurrence of T. ingens in domestic animals; did not agree to the proposal to state that

Trypanosoma lewisi can be found in Rattus rodents as it is a parasite of other rodents.

3.5.8. Equine piroplasmosis: no comments received.

3.6.2. Rabbit haemorrhagic disease: text was added to the introduction to specify the susceptible host

species in North America; a description was added to Section B.1.5 Immunostaining on

findings in bone marrow and one reference was reinstated as it includes a description of renal

mesangial cell positivity.

3.7.4. Contagious caprine pleuropneumonia: no comments received.

3.7.8. Ovine pulmonary adenomatosis (adenocarcinoma): no comments received.

3.7.9. Peste des petitsruminants(infection with small ruminant morbillivirus) (vaccine section only):

no comments received.

3.8.1. African swine fever (infection with African swine fever virus): a sentence that had been

inserted to recognise the existence of moderately virulent strains was modified to remove

mention of the chronic form of the disease; the Commission did not agree to reinstate text on

the role of the carrier and persistently infected wild pigs in eradication programmes as deletion

of this text had been proposed in consultation with the Scientific Commission in September

2019 and no Member had commented on it then; as stated in the paragraph, the biological

basis for the persistence of ASFV is still not well understood, nor is it clear what role

persistence plays in the epidemiology of the disease; and finally the issue of disease control is

not covered in the Terrestrial Manual.

3.9.2. Camelpox: no comments received.

3.9.5. Cysticercosis (including infection with Taenia solium): proposals to add text and references

to genus-specific assays, along with the suggestion to add a new section on detection of taeniid

eggs in environmental samples, food and water were deferred to the next update. Some

discrepancies between the summary and the main text regarding vaccine registration were

corrected, text on signsin pigs and immunocompromised human patientsinfected with various

Taenia species was included in the introduction; technical points on meat inspection were

updated or corrected; missing and updated references were added.

8 http://www.oie.int/en/animal-health-in-the-world/the-world-animal-health-information-system/the-world-animal-healthinformation-system/
Biological Standards Commission/February 2021 9

3.x.xx Middle East respiratory syndrome (infection of dromedary camels with Middle East

respiratory syndrome coronavirus): deleted text from the summary referring to notification as

this issue is not covered in the Terrestrial Manual; also in the summary deleted speculative

text on the risk of spill-over transmission to humans; deleted the text in Section C.

Requirements for vaccines as it is speculative and replaced with text on available candidate

vaccines; nomenclature: the Commission agreed to leave the title of the chapter unchanged as

Terrestrial Manual chapters are titled by disease name (Middle East respiratory syndrome)

and in parenthesis the title of the corresponding chapter in the Terrestrial Code, which is the

name of the infection.

NB: All amendments made in response to Member comments are highlighted in yellow in the chapters. 

The chapters can be downloaded from the following address: 

http://web.oie.int/downld/Terr_Manual/MAILING_MARCH_2021.zip

To recap, below is a list of the 38 chapters that are proposed for adoption at the 88th General Session in May 2021. 

The chapters can be downloaded from the following address: 

http://web.oie.int/downld/Terr_Manual/MAILING_MARCH_2021.zip

The chapters are also available on the Delegates website and on the website of the Biological Standards Commission.

1. 1.1.1. Management of veterinary diagnostic laboratories 

2. 2.1.2. Biotechnology in the diagnosis of infectious diseases 

3. 3.1.3. Bluetongue (infection with bluetongue virus) 

4. 3.1.7. Epizootic haemorrhagic disease (infection with epizootic hemorrhagic disease virus) 

5. 3.1.8. Foot and mouth disease (infection with foot and mouth disease virus) 

6. 3.1.10. Japanese encephalitis (vaccine section) 

7. 3.1.11. Leishmaniosis 

8. 3.1.12. Leptospirosis 

9. 3.1.15. Paratuberculosis (Johne’s disease)

10. 3.1.21. Trypanosoma evansi infection (surra in all species) 

11. 3.1.23. Vesicular stomatitis 

12. 3.2.7. Varroosis of honey bees (infestation of honey bees with Varroa spp.) 

13. 3.3.3. Avian infectious laryngotracheitis 

14. 3.3.4. Avian influenza (including infection with high pathogenicity avian influenza viruses) 

15. 3.3.5 Avian mycoplasmosis (M. gallisepticum, M. synoviae) 

16. 3.3.14. Newcastle disease (infection with Newcastle disease virus) 

17. 3.4.2. Bovine babesiosis 

18. 3.4.4. Bovine genital campylobacteriosis 

19. 3.4.5. Bovine spongiform encephalopathy 

20. 3.4.8. Contagious bovine pleuropneumonia (infection with Mycoplasma mycoides subsp. mycoides) 

21. 3.4.11. Haemorrhagic septicaemia 

22. 3.4.12. Lumpy skin disease 

23. 3.4.16 Animal trypanosomes of African origin (excluding infection with Trypanosoma evansi and 

T. equiperdum) 

24. 3.5.3. Infection with Trypanosoma equiperdum (dourine in horses) 

25. 3.5.5. Equine encephalomyelitis (Eastern, Western and Venezuelan) 

26. 3.5.8. Equine piroplasmosis 

27. 3.6.1. Myxomatosis 

28. 3.6.2. Rabbit haemorrhagic disease 

29. 3.7.4. Contagious caprine pleuropneumonia 

30. 3.7.8. Ovine pulmonary adenomatosis (adenocarcinoma) 

31. 3.7.9. Peste des petits ruminants (NB: Vaccine section only) 
10 Biological Standards Commission/February 2021

32. 3.8.1. African swine fever (NB: Introduction only) 

33. 3.8.6. Porcine reproductive and respiratory syndrome 

34. 3.9.2. Camelpox 

35. 3.9.5. Cysticercosis (including infection with Taenia solium) 

36. 3.9.6. Listeria monocytogenes 

37. 3.9.11. Zoonoses transmissible from non-human primates 

38. 3.x.xx Middle East respiratory syndrome (infection of dromedary camels with Middle East respiratory 

syndrome coronavirus) 

_______________

.../Annexes
Biological Standards Commission/February 2021 11

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 Secretariat Officer - BSC,

OIE Science Department

s.linnane@oie.int

Dr Gounalan Pavade

Chargé de mission, OIE Science

Department

g.pavade@oie.int

_______________

Biological Standards Commission/February 2021 13

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. Consultation with the Council: follow-up on Council’s suggestions

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 SOPs to include provisions for suspending laboratories and labs 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. Ad hoc Group on Sustainable Laboratories

5.3. 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
14 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

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: dourine, equine influenza, surra and leishmaniosis 

9.1.2. Standard Operating Procedure 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

10.9. Update on IAEA Zodiac Project

10.10. 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

______________