G/SPS/GEN/1256  
 
20 June 2013  
(13-3219)  Page: 1/6  
Committee on Sanitary and Phytosanitary Measures  Original: English/French/Spanish  
 
 
 PROCEDURES USED BY THE OIE TO DETERMINE THE BSE RISK STATUS 
OF MEMBER COUNTRIES 
COMMUNICATION FROM THE WORLD ORGA NISATION FOR ANIMAL HEALTH (OIE) 
The following communication, received on 14 June 2013, is being circulated at the request of the 
OIE. 
 
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Summary 
To facilitate safe international trade in animals and animal products, the OIE, at the request of 
member countries, may make an official decision on the risk status of countries for BSE (and 
certain other diseases, including foot and mouth disease) according to the provisions of the 
Terrestrial Animal Health Code  (Terrestrial Code ) and specific Resolutions adopted by the World 
Assembly of Delegates of the OIE (Asse mbly). These assessments are based on: 
 internationally agreed procedures for undertaking an import risk assessment; and 
 objective scientific criteria for determining BSE risk status, including requirements for 
disease surveillance and risk mitigation. 
The process of designation of the official BSE risk status of a country is similar to the procedures 
for elaboration of OIE standards. The official BSE risk status of the cattle population of a country is 
determined on the basis of several criteria includ ing the outcome of the risk assessment, and risk 
management including the surveillance plan and re sults, according to the relevant chapters and 
articles of the Terrestrial Code . The scientific assessment is undertaken by an ad hoc  group of 
experts reporting to the OIE Scientific Commission for Animal Diseases (the Scientific Commission). The Scientific Commission reviews the ad hoc  group recommendations, and, if 
required, will also make an in-country assessment to clarify or verify aspects of the assessment. 
The final decision on categorisation is taken by the World Assembly after consideration of this Commission's recommendations. Members countries with an officially recognised BSE risk status must submit an annual reconfirmation to the OIE on activities relevant to surveillance and feed 
controls. The official risk status is subject to annual re-confirmation by the Assembly following the 
procedures described in this paper. 
In 2004 the OIE adopted the first list of countries wi th an officially recognis ed BSE risk status. The 
official list that was adopted in 2013 is at Annex 1. 
  
 G/SPS/GEN/1256 
 
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  1  THE INTERNATIONALLY AGREED PROCEDURES OF THE OIE 
1.1.  An explanatory document outlining the standard operating procedures for official disease 
status evaluations has been compiled, and is regularly updated on the OIE website. 
1.2.  The first step is for the National Delegate of a member country (appointed by the national 
government) to request, on a voluntary basis, an assessment of their BSE risk. The Delegate 
prepares a dossier according to the category of risk (controlled or negligible) for which official recognition is sought, based on the questionnaire in Chapter 1.6. of the Terrestrial Code  and 
relevant provisions in Chapter 11.5 (BSE) and submits it to the OIE. 
1.3.  The Scientific Commission is responsible for making recommendations to the Assembly on 
the BSE risk status of OIE member countries. In this process, the Commission is supported by the OIE ad hoc  Group on the Evaluation of BSE Risk Status of Member Countries (the ad hoc  Group). 
The final decision is taken by the Assembly at the OIE General Session. 
1.4.  The documentation submitted by the applican t country is distributed electronically to the 
members of the ad hoc  Group before the meeting and a hard copy is made available during the 
meeting. All experts engaged are asked to study the dossiers attentively. 
1.5.  The experts may make use of any additional, publicly available data on the applicant country 
in their analysis of the documentation. In the ca se where clarification is needed, the applicant may 
be asked to provide additional informat ion, which should be submitted to the ad hoc  Group to 
finalise the evaluation. Based on the country's compliance with the provisions of the Terrestrial 
Code (in particular Chapter 11.5.), the ad hoc  Group makes a written recommendation to the 
Scientific Commission for consideration. 
1.6.  The Scientific Commission may endorse or reject the recommendation of the ad hoc  Group or 
may defer the decision on the BSE risk status pe nding the submission of additional information 
from the applicant. The submission  of additional information may enable a final decision by the 
Scientific Commission (with or without additional input from the ad hoc  Group). At any step in the 
process, the Commission may request interviews with  representatives of the applicant country, or 
an in-country mission to verify details provided by the applicant country. 
1.7.  After the Scientific Commission's meeting, each applicant member country whose dossier has 
been evaluated by the Commission receives written notification informing them of the outcome of 
their evaluation, and a summary record of the evaluation including reasons for a positive or negative outcome. In the case of a negative outcome, the notification may also indicate 
information gaps and/or specific areas th at should be addressed in the future. 
1.8.  A minimum of 60 days prior to each General Session, the Director General circulates a list of 
the member countries for which the Scientific Commission has recommended recognition of BSE 
risk status, to all OIE member countries. Delegates can submit their comments or objections on 
the outcome of the evaluation in writing to the OIE. Objections, if based on scientific grounds, are referred to the Scientific Commission, which may ask the advice of the ad hoc  Group. We also 
encourage direct dialogue between objectors and applicants, and therefore refer relevant 
objections to the applicant member country for them to provide clarification to the objecting member country, with a copy to OIE Headquarters. If clarification is delayed, the Scientific Commission may decide to withdraw the propos ed recommendation or defer a final decision 
pending the submission of additional evidence. 
1.9.  Delegates have a second opportunity to comme nt on the proposed BSE risk status of member 
countries at the World Assembly, following the report of the Scientific Commission and the 
presentation of a draft resolution on official BSE risk status recognition. 
1.10.  Delegates may prepare amendments, abstain or vote against the adoption of the Resolution 
containing the updated list of officially recognised BSE risk status of member countries. G/SPS/GEN/1256 
 
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  1.11.  Decisions to categorise OIE member countries for BSE risk status and other designated 
diseases are formally adopted by resolution of the World Assembly. In most cases these 
Resolutions are adopted unanimously after discussion. 
2  ASSESSMENT BASED ON OBJE CTIVE SCIENTIFIC CRITERIA 
2.1.  The Terrestrial Code  sets out the requirements to be considered in the assessment of a 
country's BSE risk, including a questionnaire (see Chapter 1.6.) requesting specific information for evaluating applications for official recognition. The three levels of BSE risk recognised by the OIE 
are: negligible BSE risk, controlled BSE risk, or undetermined BSE risk. 
2.2.  The experts in the ad hoc  Group are appointed by the OIE Director General on the basis of 
scientific excellence and geographical balance. All members of the ad hoc  Group are internationally 
renowned BSE experts who have been active in the field for decades and have an in depth 
knowledge of the science of BSE and the BSE hi story of countries and regions of the world. 
2.3.  The members of the Scientific Commission and the ad hoc  Group must comply with OIE 
requirements and procedures on confidentiality and conflict of interest. 
2.4.  For reasons of confidentiality, the BSE do ssiers submitted to the OIE are not distributed to 
other OIE member countries, regardless of the outcome of the assessment. Similarly, rejected applications always remain strictly confidential to the member country applicant. However, OIE 
member countries may request the dossier and s eek additional information directly from the 
applicant member in the context of bilateral negotiations. 
2.5.  Article 5.3.5 (point 11) of the Terrestrial Code  recommends that exporting countries provide 
access to procedures and systems that are the su bject of an equivalence judgment upon request 
of the importing country. The same principle applies to decisions on official status. 
3  THE SIGNIFICANCE OF AN OFFICIAL DECISION ON BSE RISK STATUS 3.1.  OIE member countries may make a self-declaration as to the freedom of a country, zone or 
compartment from OIE listed diseases. However, the OIE does not publish self-declaration for BSE 
or a short list of other diseases that are the subject of the OIE procedure for official recognition of disease status. 
3.2.  The OIE considers that all resolutions adopted by the World Assembly, including those 
dealing with the official recognition of risk status for BSE, fall into the SPS Agreement definition of "standards, guidelines and recommendations". The official recognition of a country's BSE risk status is an affirmation that the country meets the standards set out in the Terrestrial Code . When 
importing cattle or products of bovine origin, WTO Members should apply measures that are 
appropriate to the official BSE risk  status of the exporting country and the provisions in this Code. 
4  MAINTENANCE OF THE OFFICIAL BSE RISK STATUS 
4.1.  In order to maintain a "negligible risk" or "controlled risk" status, member countries must 
notify the OIE of any changes in the epidemiological situation and other significant events related to BSE. In addition, OIE member countries must submit an annual reconfirmation relevant to the 
risk assessment, including changes in legislation, importation of animals and commodities, controls 
at feed mills, and BSE surveillance. 
4.2.  The Scientific Commission is responsible for reviewing the official BSE status of member 
countries. 
4.3.  For highly contagious diseases such as FMD, the OIE suspends an official disease-free status 
upon receiving notification of a disease outbreak. However for a non-contagious disease such as BSE, a new case does not automatically lead to suspension of risk status. Rather, the maintenance 
of an official BSE risk status remains dependent on continued compliance with OIE standards 
(subject to annual re-evaluation) and reporting as described above. G/SPS/GEN/1256 
 
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  4.4.  In the case of countries in the neg ligible risk category, any evidence of new, 
epidemiologically significant findings, including the detection of a case in an indigenous animal, is 
evaluated very carefully by the OIE. Providing that the situation complies with the provisions in the Terrestrial Code , the status may be maintained. For example, a "negligible risk" country that 
reports a case of BSE in an indigenous bovine animal may maintain this status providing that the 
case occurred in an animal born more than 11 years ago, and that all other relevant Terrestrial 
Code provisions are satisfied. In the case of a "controlled risk" country which has reported cases of 
BSE, the status would not change if a small number of new cases were reported, provided that 
there is no significant change in the epidemiology of BSE and the effective application of risk mitigation measures in the country. 
4.5.  In general, the detection of BSE cases demo nstrates that the surveillance system is working 
as it should. 
4.6.  After consultation with the Scientific Commission, the OIE informs all member countries of 
the suspension or re-instatement of an official disease status via publication of a notice on the OIE 
website. 
Sources of information cited in this paper  Terrestrial Animal Health Code  
Chapter 1.6 Provisions on official recognition of  a member country's risk status for BSE (and 
other diseases), including the Questionnaire to be used in applications for recognition of BSE risk status: http://www.oie.int/index.php?id=169& L=0&htmfile=chapitre_1.1.6.htm  
Chapter 11.5 on BSE: 
http://www.oie.int/index.php?id= 169&L=0&htmfile=chapitre_1.11.5.htm  
 OIE procedures for official recognition of disease status: " http://www.oie.int/en/animal-
health-in-the-world/official-disease-status/official-recognition-policy-and-procedures/ " 
Resolutions of the OIE World Assembly of Delegates 
Recognition of the contagious bovine pleuropneumonia disease status of member countries - 
Resolution No. 20 of the 81st General Session (2013) 
"http://www.oie.int/en/about-us/key-texts/reso lutions-and-recommendations/resolutions-
adopted-by-the-oie-international-committee/ " 
Financial obligations - Resolution No. 26 of the 80th General Session (2012) 
http://www.oie.int/fileadmin/Home/eng/A bout_us/docs/pdf/A_ RESO_2012_Public.pdf  
 Procedures for member countries for the official recognition and maintenance of disease 
status of certain animal diseases or risk status of bovine spongiform encephalopathy and for the endorsement of a national offici al control programme 30 of the 81
st General Session 
(2013) 
"http://www.oie.int/en/animal-health -in-the-world/official-disease -status/bse/list-of-bse-risk-
status/ " 
 BSE Internet portal: http://www.oie.int/en/animal-heal th-in-the-worl d/bse-portal/  
 BSE annual reconfirmation form: Available for download at: " http://www.oie.int/en/animal-
health-in-the-world/official-disease-status/bse/ " 
 
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  ANNEX 1 
RESOLUTION NO. 20 
RECOGNITION OF THE BOVINE SPONGIFORM ENCEPHALOPATHY RISK STATUS 
OF MEMBER COUNTRIES 
CONSIDERING THAT 
 1. During the 67
th General Session the OIE World Assembly of Delegates (Assembly) established 
a procedure for annually updating a list of Me mber Countries, categorised by their bovine 
spongiform encephalopathy (BSE) risk according to the provisions of the Terrestrial Animal 
Health Code  (Terrestrial Code ), 
 
2. During the 80th General Session, the Assembly adopted Resolution No. 25, which specified 
and updated the procedure for Member Countries to follow to achieve official recognition and maintenance of status of certain diseases, 
 
3. During the 80
th General Session, the Assembly adopted Resolution No. 26, which specified 
and updated the financial implications for Member Countries applying for evaluation of official 
recognition or re-instatement of disease status to meet part of the costs defrayed by the OIE 
in the evaluation process, 
 4. Information published by the OIE is derived from declarations made by the OIE Delegate of 
Member Countries. The OIE is not responsible for publication and maintenance of Member 
Countries disease status based on inaccurate information or non-reporting of changes in epidemiological status or other significant events subsequent to the time of declaration of the 
BSE risk status. 
 THE ASSEMBLY 
 
RESOLVES THAT  1. The Director General publish the following list of Member Countries recognised as having a 
negligible BSE risk in accordan ce with Chapter 11.5. of the Terrestrial Code : 
 Argentina 
Australia 
Austria Belgium 
Brazil 
Chile Colombia Denmark 
Finland Iceland 
India 
Israel Italy 
Japan 
Netherlands New Zealand Norway 
Panama Paraguay 
Peru 
Singapore Slovenia 
Sweden 
United States of America Uruguay 
 
2. The Director General publish the following list of Member Countries recognised as having a 
controlled BSE risk in accordance with Chapter 11.5. of the Terrestrial Code : 
 Bulgaria 
Canada 
Chinese Taipei Costa Rica Croatia 
Cyprus 
Czech Republic Estonia 
France Germany 
Greece 
Hungary Ireland Korea (Rep. of) 
Latvia 
Lichtenstein Lithuania 
Luxembourg Malta 
Mexico 
Nicaragua Poland Portugal 
Slovakia 
Spain Switzerland 
United Kingdom 
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  AND 
 
3. The Delegates of these Member Countries shall immediately notify the Headquarters if BSE 
occurs in their countries or their territories. 
 
 
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(Adopted by the World Assembly of Delegates of the OIE on 28 May 2013) 
 
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