OIE • 12, rue de Prony • 75017 Paris • France

Tel.: 33 (0)1 44 15 18 88 • Fax: 33 (0)1 42 67 09 87 • www.oie.int • oie@oie.int

Original: English

February 2022

REPORT OF THE MEETING OF THE OIE BIOLOGICAL STANDARDS COMMISSION

Virtual meeting, 7–11 February 2022

PART A – Texts to be proposed for adoption in May 2022

_______

A virtual meeting of the OIE Biological Standards Commission was held from 7 to 11 February 2022. The list of 

participants can be found at Annex 1.

Considering the ongoing COVID-19 pandemic, the 89th Annual General Session will be held in a semi-hybrid format

from Monday 23 to Thursday 26 May 2022. 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 2022 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 89th General Session; and Part B (to be published in April 2022) 

will provide information about other topics discussed at the Commission’s February 2022 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 89th General Session, the OIE will once again organise information webinars to ensure that 

Members are 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 

89th General Session, and in particular the process for the adoption of standards.

1. Welcome 

Dr Montserrat Arroyo, Deputy Director General (International Standards and Science) welcomed the members 

of the Biological Standards Commission. She thanked all members for their contributions, noting the efforts to 

maintain outputs of high quality despite the significant challenges posed by the COVID-19 pandemic. She also 

extended her appreciation to the members’ employing institutions and national governments. Dr Arroyo briefed 

the members on the ongoing process to prepare the 2022 OIE General Session, including the planning of preGeneral Session webinars that will be conducted by the OIE Specialist Commissions to inform Members on the 

revised and new standards being proposed for adoption. The Biological Standards Commission webinar will be 

held on 12 April 2022 from 1.00 to 3.00 pm local time in Paris. She also informed the Commission that the 

Technical Item would be on OIE and Veterinary Services engagement in global, regional and national 

Emergency Management Systems. Dr Arroyo summarised ongoing work on the OIE standards development 

and review system, including the development and planning for digital tools. Finally, she informed the 

Commission of an ‘after-action review’ conducted by the OIE in response to the COVID-19 pandemic.

Dr Monique Eloit, the OIE Director General, met the Commission later in the week and thanked its members 

for their support and commitment to achieving OIE objectives. She recognised the Commission’s efforts and 

adaptability to develop new ways of working to sustain the OIE standard-setting process despite the challenges 

imposed by the COVID-19 pandemic. Dr Eloit provided an update on the 89th OIE General Session preparation 

and informed the Commission of new initiatives to review the OIE Science system. 
2 Biological Standards Commission/February 2022

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).

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

second-round comment and proposal for adoption in May 2022

The Commission reviewed the comments that had been received on the 20 draft chapters that had been 

sent for first-round Member comment in October 2021. The Commission approved 19 for circulation, 

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

Assembly in May 2022.

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

New Zealand, United Arab Emirates, United Kingdom and United States of America.

The 19 chapters and a summary of the main amendments made in response to Member comments are 

provided below:

Glossary: deleted “eggs” and “avian” from the definition of specific antibody negative 

(SAN) so that it refers to animals including their eggs.

1.1.8. Principles of veterinary vaccine production: no comments received on the text circulated, 

which will be put forward for adoption. One Member had submitted comments on another 

section of the chapter: the Commission agreed to include the chapter in the next review cycle 

(2022/2023) so that these comments could be addressed.

2.3.4. Minimum requirements for the production and quality control of vaccines: added “where 

alternative methods exist” to the proposed new text for clarification.

3.1.4. Brucellosis (infection Brucella abortus, B. melitensis, B. suis): in the Summary, clarified that 

clinical signs include infertility and that the organisms are also excreted in urine and semen 

as well as milk and uterine discharges; this point was reiterated in Section A.1.1 Infection 

with Brucella in cattle where a sentence was added stating that Brucella abortus can be shed 

in semen, seminal fluid and urine; updated Section A.1.4 Infection with Brucella in other 

domestic, captive–wild or wild species to correct the scientific name of elk/wapiti and to 

include sika deer (Cervus nippon) as a species where brucellosis is observed, added 

B. abortus in wood bison in Canada as a third reservoir of infection in wild ruminants, and 

added that the sporadic reports of B. melitensis isolation from dogs are associated with

contact with infected sheep or goats or ingestion of placenta or aborted fetuses; in Section 

B.1.2.3 Collection and culture of samples added that milk culture can be valuable for 

screening individual animals as well as herds; in Section B.1.4 Nucleic acid recognition 

methods, clarified that both the updated Bruce-ladder PCR protocol and the modified 

multiplex PCR assay described by Kang et al. (2011)1 can discriminate between B. suis and 

B. canis, and allows the differentiation of B. microti; in Section B.2.5 Enzyme-linked 

immunosorbent assays, agreed that the study by Praud et al. (2012) on porcine serological

tests does not support the text on the sensitivity and specificity of the indirect ELISA2 and 

RBT3 for porcine samples and replaced it with supporting references; in Section B.3.1 

Brucellin skin test, removed reference to the brucellin INRA preparation as it is no longer 

available; in Section C. Requirements for vaccines, replaced references to authorisation, 

1 KANG S.I., HER M., KIM J.W., KIM J.Y., KO K.Y., HA Y.M. & JUNG S.C. (2011). Advanced multiplex PCR assay for 

differentiation of Brucella species. Appl. Environ. Microbiol., 77, 6726–6728.

2 ELISA: Enzyme-linked immunosorbent assay

3 RBT: rose bengal test
Biological Standards Commission/February 2022 3

registration or licensing with “regulatory approval” to be consistent with the other chapters; 

added a new Section C.1.1.5 Vaccination in other species. 

In Section B.2 Serological tests, the Commission did not agree to add that the complement 

fixation test can be impacted by anti-complementary activity with non-inactivated serum 

because anti-complementary activity in serum is not just due to non-inactivated serum.

In Section B.2.3.1.2 Antigen standardisation, did not agree to change the “highest” to the 

“lowest” and vice versa in text stating that the dilutions (in negative goat serum) of the

International standard anti-Brucella melitensis Serum (ISaBmS) that must give a positive 

result and negative result have been established at 1/16 and 1/200. The intent of the sentence 

is to convey that the highest dilution (most dilute) that must be positive is 1/16, i.e. must 

always be positive. A higher dilution may also be positive but this is not a must. A 1/8 

dilution must also be positive, but this is not the highest dilution that must be positive (it is 

lower). Likewise, a 200-fold dilution (1/200) must be negative. A 1/100, a lower dilution, 

can also be negative, but this is not a must. The 1/200 is the lowest dilution that must be 

negative. The statement is about the thresholds for the serum standard being positive or 

negative and these are the minimum standards for analytical sensitivity and specificity with 

this standard.

In Section C.1.1.4 Vaccination in pigs, the Commission did not accept a proposal to include 

a section on Brucella suis strain S2 vaccine, as the majority of OIE Reference Laboratory 

experts felt there was insufficient evidence at this time to include additional information or 

recommendations on the S2 vaccine. The chapter will be proposed for adoption in May, and 

this issue will be further discussed at the next meeting in September 2022.

3.1.6. Echinococcosis (infection with Echinococcus granulosus and with E. multilocularis): 

agreed to use Echinococcus granulosus sensu lato (E. granulosus s.l.) and E. granulosus 

sensu stricto (s.s.) throughout the chapter in accordance with the international consensus on 

terminology to be used in the field of echinococcosis, and to remove most instances of the 

term “hydatid” from the chapter; in the Summary, clarified that the coproantigen approach 

is valuable for epidemiological screening programmes; added that diagnosis in animals can 

be confirmed by DNA sequencing as well as PCR4

; in the Summary and Introduction

correctly referred to genotypes and not strains of Echinococcus; in the Introduction, added 

a statement that the current view is that there are nine species in the genus Echinococcus, 

and clarified the current molecular phylogeny and taxonomy of the G2 genotype and the 

species E. canadensis; also in the Introduction, deleted E. equinus as a species where there 

is no evidence of infections in humans as there are reports of human infection with this 

species; in Table 1. Useful characteristics for identification of Echinococcus species 

amended “polycystic” cysts to “unicystic cysts in the column covering metacestode for

E. oligarthra; in Section A.1 Echinococcus granulosus (sensu lato) replaced “specificity” 

with “predilection” as Echinococcus species are not specific to intermediate hosts; corrected 

the description of Echinococcus vogeli in Section A.4 from “polycystic echinococcosis” to 

“neotropical echinococcosis” as usually presents as a single cyst; added “and identification” 

after “Detection” [of the agent] to the heading in Table 2 Test methods available for the 

diagnosis of echinococcosis and their purpose and added a footnote highlighting that meat 

inspection may not include confirmation that cysts are due to E. granulosus infection; added 

text to Section B.1.2.1 Necropsy indicating that tissues should be deep frozen before 

necropsy to kill any eggs and that E. multilocularis can survive in liquid nitrogen for 

35 years and still be infective; updated Table 3. PCR primers used for coproDNA detection 

to include more recent methods and references; in Section C1.1 Intermediate hosts, replaced 

“reduce transmission of cystic echinococcosis to humans” by “reduce human exposure to 

cystic echinococcosis”, as the parasite is transmitted not the disease.

3.1.8. Foot and mouth disease (infection with foot and mouth disease virus): in the Summary, added 

Seneca Valley virus infection to complete the list of vesicular diseases that cannot be 

differentiated clinically from FMD; added “detection and” to the section on identification of 

the agent in the Summary, and amended Table 1 Test methods available for the diagnosis of 

4 PCR: polymerase chain reaction
4 Biological Standards Commission/February 2022

FMD and their purpose and Section B.1 accordingly, to qualify that it is essential to confirm 

the presence of FMDV following virus isolation; deleted footnote 1 from Table 1 and 

harmonised the style of the remaining two footnotes; in Section B.1 added heart muscle from 

cases with myocarditis to the sample types, and deleted part of the last sentence referring to 

the need for viral isolate for certain tests and studies as it was out of context. 

Two Members had submitted comments on other parts of the chapter that had not been 

circulated. These comments would be addressed by the experts when they review the entire 

chapter in the next review cycle.

3.1.x. Mammalian tuberculosis (infection with Mycobacterium tuberculosis complex): in the 

Summary, added a statement that mammalian tuberculosis is a barrier to trade, added the full 

name of spoligotyping (spacer oligonucleotide typing), and added mycobacterial 

interspersed repeat units – variable number tandem repeat (MIRU-VNTR) as it is a 

commonly used genotyping method; also in the Summary, clarified that vaccination of cattle 

is prohibited in many countries as the vaccine may sensitise animals to the tuberculin skin 

test and other tuberculin-based immunological tests; added text in the Introduction stating 

that Mycobacterium microti has also been found widespread in wild boar and that the 

microscopic test can often give negative results, even in sick animals, due to the limited 

presence of mycobacteria; in Table 1 Test methods available for use in cattle, goats, and 

camelids and their purpose amended the ratings of the tests for detection of immune 

response in goats and camelids, including rating the lateral flow antibody test “+” for all 

species (cattle, goats and camelids); deleted text from Section B.2.2.2.1. Single cervical test

on situations where a high false positive rate is expected because it is beyond interpretation 

of the test itself to its use in the context of control/eradication, which is not in the remit of 

the Terrestrial Manual; corrected the figures in the interpretation of the results of the 

Comparative cervical test (Section B. 2.2.2.2); added a section on interpretation of test 

results in camelids; in Section 3.2. Serology for detection of specific antibodies indicated

that serology is used as a complementary test to the skin test and 15–30 days after skin testing

in camelids.

The Commission did not agree to include another multiplex real-time PCR proposed by one 

Member because, as mentioned in the text, a number of PCR protocols have been reported 

using different targets, primers or methods. In reply to a Member that proposed changing 

the word “anthroponoses”, the Commission noted that the word “zoonosis” tends to be used 

for infections from animals to humans and that “anthroponosis” (also known as “reverse 

zoonosis” or “zooanthroponosis”) can be accepted to describe human-to-animal 

transmission.

3.1.14. Nipah and Hendra virus diseases: in the Summary, added text to highlight the variable and 

nonspecific clinical signs that horses infected with Hendra virus (HeV) can display, and text 

clarifying the role of contact with urine, saliva or birth products from infected flying-foxes 

in transmission to horses and direct contact with bodily fluids for transmission between 

horses; also in the Summary, added that human-to-human transmission of Nipah virus (NiV) 

has been seen in outbreaks in India as well as Bangladesh, and updated the information on 

the recent genetic characterisation of NiV; in the Introduction, clarified the occurrence of 

HeV cases in horses within the geographical range of the Pteropus bats in Australia, added 

information and a reference on clinical signs in humans, specified the likely route of 

transmission from the wildlife reservoir to humans in the Bangladesh outbreaks, and pointed 

out that two henipa-like viruses have been isolated from shrews in the Korea (Rep. of); in 

Section B.2.1.1 Sampling and submission of specimens added a statement that in pregnant 

animals or in cases of abortion, uterus, placenta and fetal tissues should be included because 

it has been deleted from the Summary; in Table 3 Primers used for conventional PCR and 

sequencing of HeV, added a footnote to clarify that the HeV-P gene semi-nested 

conventional PCR also detects HeV-g1 and HeV-g2, but with much lower sensitivity for 

HeV-g2; in Section B.4.2.2. Hendra B-ELISA method, emphasised that other ELISA 

protocols for henipavirus diagnostics in pigs have been published; in Section 4.3 Bead-based 

assays, deleted a sentence on the more stringent biological risk management required for 

ELISAs as all ELISA protocols are now established with recombinant antigen, which is not 

associated with any biosafety risk; in Section C. Requirements for vaccines, added a 

statement that there is no vaccine approved for the prevention of HeV in humans.
Biological Standards Commission/February 2022 5

3.1.22. Tularemia: In the Summary, added a statement on the cause of oropharyngeal and pneumonic 

infections along with information on how the disease spreads and how humans can acquire 

it because this information is relevant to work-safety issues in the laboratory and the 

potential use of Francisella tularensis as a biological agent; in the Introduction, added a 

statement that Type B has been found in possums in Australia; also in the Introduction, 

deleted reference to the living bacteria occurring in faeces and expanded the statement on 

how infection can occur to include contact with sick animals, infected tissues, consumption 

of infected animals, drinking or direct contact of contaminated water; mention of the OIE 

Reference Laboratory was deleted as currently there is none; in Table 1. Test methods 

available for the diagnosis of tularemia and their purpose, the rating for the real-time PCR 

was changed from “+++” to “+” and the rating of the conventional PCR was changed from 

“++” to “+”, both for the purpose “Population freedom from infection” as it is only useful 

in very limited circumstances (e.g. in ticks or other arthropods), but has little or no relevance 

for screening subclinically infected animals, the rating for the conventional PCR was 

changed from “–“ to “+++” for the purpose “Confirmation of clinical cases” as PCR is a 

reliable confirmatory tool as pointed out in the text, and added a footnote emphasising that 

serology is of limited value in susceptible animals, which usually die before development of 

specific antibodies; in Section B.1.3.3 Identification of isolates, added a paragraph and a 

reference on MALDI-TOF MS5 because MALDI-TOF MS is a quick and reliable method 

for the identification of these bacteria; in Section B.2.1 Agglutination tests, updated the

description of the how the antigen is cultured as antigen preparation more typically uses 

formalin and safranine instead of ethanol and crystal violet.

One Member had proposed adding a new section on molecular epidemiology for outbreak 

investigations. The Commission felt that the proposal related not just to this chapter but to 

the Terrestrial Manual in general. The Commission decided to put this comment on hold for 

the present and to consider at the next meeting in September if they would like the topic of 

molecular epidemiology to be covered in the Terrestrial Manual.

3.2.1. Acarapisosis of honey bees (infestation of honey bees with Acarapis woodi): changed 

“infection” to “infestation” throughout the chapter; in the Summary, added that the mites can 

also be found at the base of the bee’s wings, and corrected the maximum number of eggs 

that mites lay from 20 to 14; in the Summary and Introduction, clarified that the mite being 

described is the adult female mite, Introduction, added a sentence on the effects of heavy 

mite infestations in winter months; added “detection and” to the section on identification of 

the agent in the Summary, and amended Table 1 Test methods available and their purpose

and Section B.1 accordingly; clarified that though drones can be found to have a higher 

abundance of mites per bee, the most significant caste affected by Acarapis woodi is the 

worker bee population, which is present in the colony throughout the entire year, including 

the seasons when a colony is most vulnerable: winter and early spring; in Section B.1.1 

Microscopy – dissection of individual bees, changed the freezing interval from ‘24 hours’ to 

‘48 hours’, to ensure that bees have been euthanised.

3.3.9. Fowl cholera: in the Summary, clarified the names of eight LSP6 genotypes: L1–L8; in 

Section C. Requirements for vaccines, replaced references to authorisation, registration or 

licensing with “regulatory approval” to be consistent with the other chapters.

3.3.15. Turkey rhinotracheitis (avian metapneumovirus): in the Summary added that vaccines are 

available for both turkey rhinotracheitis (TRT) and swollen head syndrome (SHS); in the 

Introduction, corrected the statement referring to two new isolates reported from North 

America – the original text referred to genotypes; added a sentence and a reference on coinfection with other viruses and fungi; included some information on clinical signs in 

chickens; in Section C. Requirements for vaccines, replaced references to authorisation, 

registration or licensing with “regulatory approval” to be consistent with the other chapters.

3.6.2. Contagious equine metritis (CEM): in Section A.1 Description and impact of the disease, 

removed the mention of vaccination as there are no vaccines available for CEM; in Section 

A.3 Differential diagnosis, added clitoral fossa, clitoral sinuses and endometrium as they are 

5 MALDI-TOF MS: Matrix assisted laser desorption ionisation time of flight mass spectrometry

6 LSP : Lipopolysaccharide
6 Biological Standards Commission/February 2022

the recommended swabbing sites for mares; added “and identification” to Table 1 Test 

methods available for the diagnosis of contagious equine metritis and their purpose and 

added “Detection and” to the title of Section B.1; added a section on MALDI-TOF; in 

Section B.1.4 Molecular methods, added a sentence clarifying that a minimum of five 

suspect colonies be taken for confirmation by PCR to reduce the possibility of selecting the 

wrong colony; in Section B.1.4.1 Real-time PCR, added two references; in Section B.1.4.2 

Other PCRs, emphasised that other PCRs can only be used if they have been validated to 

OIE Standards (Chapter 1.1.6) as fit for use for defined purposes; in Section B.1.5.2 Semen 

testing, added text and a reference stating that growth of the organism is not always inhibited 

by antibiotics in semen extender.

3.8.11. Scrapie: in the Summary, clarified that epidemiological data suggest atypical scrapie does 

not present like an infectious disease but instead it has a sporadic distribution; still in the 

Summary section on detection of PrPSc in lymphoreticular tissues, included rectoanal 

mucosa-associated lymphoid tissue, third eyelid biopsies and palatine tonsil as they are the 

important tissue samples for biopsies in live animals, while emphasising that such testing is 

not appropriate for detection of atypical scrapie as there is little or no involvement of the 

lymphoreticular system or of a proportion of classical scrapie cases, so they can be used only 

to confirm the presence of infection and cannot be used to prove its absence; in Section A.2. 

Host genetic factors, clarified that there is some evidence suggesting that certain codons 

may be associated with susceptibility to the disease in goats and updated the European Food 

Safety Authority (EFSA) reference; in Section B.3 Genetic screening for resistance, added 

text stating that while a breeding programme for resistance in goats may not be feasible due 

to the low abundance of resistant polymorphisms, screening programmes at the local level 

can help to identify resistant goats to restock affected herds after the application of 

genetically-based selective culling, as it has been applied for decades in sheep.

In the Summary, a suggestion to include text stating that variations at some codons can affect 

susceptibility to atypical scrapie was rejected as it was vague and confusing and did not add 

to the context of the paragraph. Also in the Summary, the proposal that diagnosis is 

confirmed by vacuolation and immune-detection was not accepted as in many countries only 

one method is required: it was agreed to specify that vacuolation is TSE-specific. Finally in 

the Summary, the proposal to change “brain” to “brainstem” was rejected because “brain” 

includes the cerebellum, which is necessary for the detection of atypical scrapie, so 

“brainstem” is incomplete. In Section A.2. Host genetic factors, a proposal to add a table 

grouping alleles by level of susceptibility with an explicit indication of the resistance 

associated to ARR allele was rejected as it was felt to be beyond the scope of the Terrestrial 

Manual, which is for diagnostic tests and not for preventative medicine: the PrP genotype 

has no implication on the diagnostic procedure. Also in Section A.2, a proposal to include a 

reference to a case-control study in goats was rejected because the analysed samples were 

sourced from a restricted geographical area and given the genetic variability of the PrP in 

goats and how difficult it is to identify genetic resistance markers that are applicable 

universally to goat TSEs, it would be inappropriate to mention the reference in the 

Terrestrial Manual as it may mislead readers. In addition the information is of limited value 

as no Veterinary Authority would implement a preventative strategy to eliminate atypical 

scrapie – it is classical scrapie that they try to stamp out. In Section A.3 Strain 

characterisation, a Member commented that the chapter should be amended to reflect the 

biodiversity of classical scrapie strains. In reply, the Commission stressed that the field of 

strain typing in TSEs7 is a specialist subject and beyond the purpose of this Terrestrial 

Manual, which focuses on diagnosis of the disease. The chapter does not describe strain 

characterisation but discrimination between BSE8 and scrapie, which until a few years ago 

was referred to as strain discrimination. To address this, the title of the Section was changed 

to Discrimination between classical scrapie and BSE and the first sentence on strain 

characterisation was deleted. In Section B.1.1 Specimen selection and preparation, a

proposal to add that CNS material is fixed in neutral buffered formalin was rejected as other 

fixatives may also be used. In Section B.1.2 Histological examination, a proposal to add that 

classical scrapie lesions frequently affect “the spinal tract nucleus of the trigeminal nerve”

7 TSEs: transmissible spongiform encephalopathies 

8 BSE: bovine spongiform encephalopathy
Biological Standards Commission/February 2022 7

was rejected as the dorsal nucleus of the vagus nerve, which is mentioned, is the primary 

target area.

3.8.13. Theileriosis in sheep and goats (infection with Theileria lestoquardi, T. luwenshuni and 

T. uilenbergi): changed the rating of the IFAT9 and ELISA from “–” to “++” for the purpose 

“individual animal freedom from infection prior to movement” and added a footnote to 

clarify that for this purpose (animal movement) serology should not be used alone but always 

combined with an agent detection test no comments received.

3.9.3. Classical swine fever (infection with classical swine fever virus) (diagnostic section only): 

in Table 1. Test methods available for the diagnosis of classical swine fever and their 

purpose, clarified that the PCR is a reverse-transcription PCR; in Section C. Requirements 

for vaccines, replaced “authorised”, “licensed” and “registration” with “granted regulatory 

approval” and “approved” to be consistent with the other chapters.

3.10.1. Bunyaviral diseases of animals (excluding Rift Valley fever and Crimean–Congo 

haemorrhagic fever): for Cache Valley virus (CCVV), extended the geographical range from 

North America to the Americas and included goats as one of the main animal species 

affected; updated the information on prevalence including adding a more recent reference; 

for Akabane virus (AKAV), added the information that antibodies have been found in 

horses, donkeys, buffalo, deer, camels, and wild boar, but there are currently no descriptions 

of Akabane-associated illnesses in these species; added text and two references to multiplex 

RT-PCR methods that have been developed for rapid, sensitive detection of multiple 

arboviruses, including AKAV; for Schmallenberg virus (SBV) added cerebellar hypoplasia 

and enlarged thymus as clinical signs; and for Nairobi sheep disease virus (NSDV) added a 

statement that sheep are more susceptible than goats; expanded the information on and the 

protocol for the IFAT.

The Commission did not agree to increase the incubation period for the disease from 2–

5 days to 2–15 days because though there are reports of infections where clinical signs have 

only appeared up to 15 days after the application of infected ticks to the animal, this appeared 

to be due to a delay in the tick establishing feeding, while in experimental inoculations, signs 

appear a maximum of 5 days after infection; neither did the Commission agree to add text 

stating the agent was transmitted transovarially in the tick according to Daubney & Hudson, 

193410: transovarial transmission, where larvae bred from infected adults are themselves 

infectious, has not been demonstrated in any species of tick except Rhipicephalus 

appendiculatus, and Daubney & Hudson (1934) specifically say that they did not observe 

this for Ambylomma variegatum.

A Member commented that the chapter lacks diagnostic details and test protocols. The 

Commission is aware of this situation and intends to address it. The Commission thus agreed 

to put the chapter forward for adoption in May this year, and to ask the contributing experts 

to further update the chapter by including Table 1 Test methods available and their purpose

and protocols; the resulting updated chapter will be added the next review cycle (2022/2023).

3.10.4. Cryptosporidiosis: updated the number of Cryptosporidium species as well as the number of 

genotypes and included a recent reference on taxonomy and molecular epidemiology of 

Cryptosporidium; updated Table 1. Some differences among species within the genus 

Cryptosporidium by including information that was missing and adding new species; as 

potassium dichromate (K2Cr2O7) is toxic, the recommendation to perform all procedures in 

a fume hood or a ducted Class II biosafety cabinet (ducted = vents externally to the room)

was added; in Section 2.3.2.1 Preparation of flotation solution, added information on how 

long the solutions can be kept for once made.

3.10.6. Mange: moved Section 3 Serological tests to Section 1.3 Serological tests and added a 

sentence and references on the development of serodiagnostic methods based on 

recombinant proteins; added cats as a domestic host for Sarcoptes scabei; added horses as a 

9 IFAT = indirect fluorescent antibody test

10 DAUBNEY R. & HUDSON J.R. (1934). Nairobi sheep disease; natural and experimental transmission by ticks other than 

Rhipicephalus appendiculatus. Parasitology, 26, 496–509.
8 Biological Standards Commission/February 2022

species infected with Chorioptic mange; in Section B.2.2.1 Demodecidae, clarified that

Demodex gatoi can be transferred between cats of any age while transfer between other hosts 

occurs only by very close contact between individuals; updated Section C. Requirements for 

vaccines including adding two references.

3.10.7. Salmonellosis: amended the title of Section A.1 to include nomenclature; reinstated Grimont 

& Weill (2007)11 as it includes relevant and current information on Salmonella species; 

clarified that modified semi-solid Rappaport Vassiliadis (MSRV) is an agar and that it has 

been validated for environmental samples; amended Sections B1.1.4 Example test 

procedures for isolation of Salmonella from food, feedstuffs, faecal and environmental 

samples and Section B.2.5.5 Preparation of flagellar antigens, to bring them in line with 

ISO 6579-1; in Sections B.1.2 Quantification methods, B.1.3 Identification of suspect 

colonies, and B.1.4. Immunological and nucleic acid recognition methods, corrected the ISO 

references; in Section C. Requirements for vaccines, replaced references to authorisation, 

registration or licensing with “regulatory approval” to be consistent with the other chapters.

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

To recap, below is a list of the 19 chapters that are proposed for adoption at the 89th General Session in May 2022. 

The chapters can be downloaded from the following address: 

http://web.oie.int/downld/Terr_Manual/MAILING_MARCH_2022.zip

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

Glossary

1. 1.1.8. Principles of veterinary vaccine production

2. 2.3.4. Minimum requirements for the production and quality control of vaccines

3. 3.1.4. Brucellosis (infection with B. abortus, B. melitensis, B. suis)

4. 3.1.6. Echinococcosis (infection with Echinococcus granulosus and with E. multilocularis)

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

6. 3.1.14. Nipah and Hendra virus diseases

7. 3.1.22. Tularemia

8. 3.1.X. Mammalian tuberculosis (infection with Mycobacterium tuberculosis complex)

9. 3.2.1. Acarapisosis of honey bees

10. 3.3.9. Fowl cholera

11. 3.3.15. Turkey rhinotracheitis (avian metapneumovirus) 

12. 3.6.2. Contagious equine metritis

13. 3.8.11. Scrapie

14. 3.8.13 Theileriosis in sheep and goats (infection with Theileria lestoquardi, T. luwenshuni and 

T. uilenbergi)

15. 3.9.3. Classical swine fever (infection with classical swine fever virus)

16. 3.10.1. Bunyaviral diseases of animals (excluding RVF fever and Crimean–Congo haemorrhagic 

fever)

17. 3.10.2. Cryptosporidiosis

18. 3.10.6. Mange

19. 3.10.7. Salmonellosis

_______________

.../Annexes

11 GRIMONT P.A.D. & WEILL F.-X. (2007). Antigenic Formulae of the Salmonella Serovars, Ninth Edition, World Health Organization 

Collaborating Centre for Reference and Research on Salmonella. Institut Pasteur, Paris, France.
Biological Standards Commission/February 2022 9 

Annex 1 

MEETING OF THE OIE BIOLOGICAL STANDARDS COMMISSION

Virtual meeting, 7–11 February 2022

__________

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

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

Prof. Ann Cullinane

(Vice-President) 

Head of the Virology Unit

Irish Equine Centre

Johnstown, Naas

Co. Kildare

IRELAND

ACullinane@irishequinecentre.ie

Dr Satoko Kawaji

(Member) 

Principal Scientist

Division of Infectious Animal Disease 

Research, National Institute of Animal 

Health, Naro

JAPAN

skawaji@affrc.go.jp 

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 Chris Oura

(Member) 

Professor of Veterinary Virology

Faculty of Medical Sciences

The University of the West Indies

TRINIDAD AND TOBAGO

chris.oura@sta.uwi.edu

CONSULTANT EDITOR OF THE TERRESTRIAL MANUAL

Dr 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

_______________
10 Biological Standards Commission/February 2022

Annex 2 

MEETING OF THE OIE BIOLOGICAL STANDARDS COMMISSION

Virtual meeting, 7–11 February 2022

__________

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 2022

3.2. Follow-up from the General Session: Chapter 3.4.12 Lumpy skin disease

3.3. Follow-up from September 2021: conclusions and recommendations from the OIE Scientific and Technical Review

issue on diagnostic test validation science

3.3.1. Progress on development of a template of the validation data requested for addition to a future online list of 

validated tests

3.3.2. Progress on development of a template for a new Terrestrial Manual section on the rationale behind the 

selection of tests included in Table 1. Test methods available and their purpose

3.3.3. Terrestrial Manual validation chapters: chapter 1.6 Principles and methods of validation of diagnostic 

assays for infectious diseases and chapters 2.2.1 to 2.2.8 in Section 2.2 Validation of diagnostic tests

3.4. Follow-up from September 2021: request to update Chapter 3.1.1 Anthrax to include a new easier to produce Bacillus 

anthracis capsule stain

3.5. Member comments on chapters 2.3.1 The application of biotechnology to the development of veterinary vaccines

and 3.1.17 Rabies (infection with rabies virus and other lyssaviruses) 

3.6. Correction to Table 1 Test methods available for the diagnosis of peste des petits ruminants and their purpose of 

Chapter 3.8.9 Peste des petits ruminants (infection with small ruminant morbillivirus) 

3.7. Terrestrial Manual status: update on chapters selected for the 2022/2023 review cycle

4. Liaison with other Commissions

4.1. Horizontal issues among the Specialist Commissions

4.1.1. Review of case definitions

4.2. Scientific Commission for Animal Diseases

4.2.1. Follow-up General Session: emerging recombinant lumpy skin disease virus strains, their correct diagnosis 

and notification)

4.2.2. Review of assessments of diseases against listing criterion 3: delisting assessments

4.3. Terrestrial Animal Health Standards Commission

4.3.1. Updates from the September 2021 Code Commission meeting 

4.3.2. Technical questions on Chapter 11.10 Infection with Theileria annulata, T. orientalis and T. parva

4.3.3. Technical questions on Chapter 8.8 Infection with foot and mouth disease

4.4. Aquatic Animal Health Standards Commission

4.4.1. Nothing for this meeting

5. OIE Reference Centres

5.1. Annual reports of Reference Centre activities in 2021

5.2. Applications for OIE Reference Centre status

5.3. Changes of experts at OIE Reference Centres

5.4. Review of new and pending applications for laboratory twinning
Biological Standards Commission/February 2022 11

5.5. Inconsistencies among OIE Reference Laboratories in results obtained using the real-time RT-PCR for African horse 

sickness

Reference Laboratories – Implementation of the SOPs 

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

according to their 2018 annual report

5.7. Follow-up September: feedback from the Laboratories that are not complying with the key ToR according to 2020 

annual report

5.8. Further develop SOPs to include provisions for suspending laboratories and for handling laboratories that 

temporarily have no designated expert

Collaborating Centres – Implementation of the SOPs

5.9. Follow-up September meeting: feedback on the mapping exercise for the existing Centres against the list of main 

focus area and specialties 

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

report 

5.11. Follow-up September: feedback from the Centres that are not complying with the key ToR according to 2020 annual 

report 

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

Reference Centre networks

5.13. Update on the three Reference Laboratory networks (rabies, PPR and ASF) 

5.14. Outcomes of OIE Reference Centre December 2021 meeting in SADC region

5.15. OIE Training Portal and OIE Training Platform activities: a good example of OIE Collaborating Centre collaboration

5.16. Request to change title of an OIE Collaborating Centre

6. Ad hoc Groups

Update on activities of past ad hoc Groups

6.1. Ad hoc Group on Replacement of the International Standard Bovine Tuberculin: update on the replacement ISBT

7. International Standardisation/Harmonisation

7.1. OIE Register of diagnostic kits: 

7.1.1. Update and review of new or renewed applications

8. Resolutions for the General Session

8.1. List of resolutions that will be presented in May 2022

9. Matters of Interest for consideration or information

9.1. Update on OFFLU

9.2. Update on rinderpest 

9.3. Update on COVID-19

9.4 EuFMD/FAO project for a pre-qualification system for veterinary medicines

9.5. Update on Global Burden of Animal Diseases programme

10. Any other business

10.1. Workplan

10.2. Dates of the next Biological Standards Commission meeting: 5–9 September 2022

11. Meeting review

______________ 
12 Biological Standards Commission/February 2022