STC Number - 96

Geographical BSE risk assessment

Maintained by: European Union
Raised by: Canada; Chile; India
Supported by: United States of America
First date raised: July 2001 G/SPS/R/22 paras. 22-26
Dates subsequently raised: June 2005 (G/SPS/R/37/Rev.1 (EN), paras. 35-36; G/SPS/R/37 (FR, ES), paras. 35-36)
October 2005 (G/SPS/R/39 paras. 226-227)
June 2007 (G/SPS/R/45 paras. 44-45)
Number of times subsequently raised: 3
Relevant documents: Raised orally
Products covered: 0201 Meat of bovine animals, fresh or chilled.; 0202 Meat of bovine animals, frozen.
Primary subject keyword: Animal Health
Keywords: Animal health; Human health; International Standards / Harmonization; Risk assessment; Zoonoses; Bovine Spongiform Encephalopathy (BSE)
Status: Partially resolved
Solution: In June 2007, Canada indicated that the concern had been resolved as it had been overtaken by the OIE's new risk assessment framework and cateogorization system for BSE risk posed by countries.
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

In July 2001, the representative of Canada requested an update on the development, application and future evolution of the EC geographical BSE risk assessment (GBR) process. In Canada's understanding, the GBR rating system had initially been designed as an internal mechanism, then evolved into something that had application to third countries. Canada asked how the system ensured consistency in the application of the risk assessment process, and how a particular assessment could be reviewed as time passed and risks diminished. Canada also asked for an explanation of the process, and how information on internal situations was combined with assessments of external risks. The GBR system seemed to focus disproportionately on risks from the United Kingdom. In light of the information presented by the European Communities on its new TSE regime, Canada wondered how these two mechanisms fit together. Canada also noted that the OIE was developing a system to verify countries' own assessments of their BSE status, and wondered how that would relate to the EC system.

The representative of the United States echoed many of Canada's concerns. The United States had undertaken numerous actions to prevent the introduction of BSE, including an extensive surveillance programme, a ban on feeding MBM to ruminants, and restrictions on imports of certain products from countries affected by BSE or posing an unacceptable risk. After more than ten years of active surveillance at levels above the international standard, the United States had found no evidence of BSE or other TSEs in cattle. The United States was concerned that the European Communities was applying similarly stringent measures to countries that were not affected by the disease or which had significantly different risk factors. This practice lacked scientific justification and ran counter to the existing international standards. The minimum number of neurohistological investigations called for in the EC legislation was far greater than that recommended under the international standard. It was not entirely transparent how country classifications would be determined nor what requirements would be applied in the meantime. The United States was worried that the classification would be based on the EC geographical BSE risk assessments. The United States had submitted detailed comments on the risk assessment methodology and on the draft GBR of the United States, identifying a number of problems with the methodology and with the information related to the United States. In addition, the United States was concerned that many countries might regard the GBR as equivalent to an international standard, although it had no more standing than any other WTO Member's legislation. The United States urged all countries to take the OIE standard into account when developing their own BSE measures.

The representative of the OIE clarified that the OIE would deal only with recognition of BSE freedom, not with the other four categories contained in the BSE chapter of the International Animal Health Code (G/SPS/GEN/266). The WHO/FAO/OIE conference on BSE had concluded that potentially BSE-infected materials had been distributed throughout the world through trade, and that all countries should evaluate their potential exposure in order to protect public health and prevent further dissemination of infectivity. When assessing their internal and external risk factors, countries should take full account of the existing international recommendations, particularly those of the OIE Code. The aim should be to enable reliable categorization into one of the five different BSE statuses specified in the Code. The conference had strongly supported OIE plans to incorporate a risk-based component into the Code Articles on BSE categorization, instead of defining categories based only on incidence of the disease. To help member countries carry out their risk assessment, the Commission on FMD and other Epizootics of the OIE had received the mandate to develop guidelines, taking into account the experience from the GBR assessments. Countries were encouraged to utilise these OIE guidelines for their own internal assessments, bilateral negotiations and third party assessments.

The representative of the European Communities indicated that GBR analyses were based on information provided by interested trading partners to a 1998 questionnaire. The methodology for the GBR had been established by the EC Scientific Steering Committee which was formed by scientists selected by a public tender every four years and was open to nationals of non-European countries. The new BSE-TSE measure was in conformity with the OIE Code, but the GBR pre-dated the current OIE Code. The GBR had been designed to assess the BSE risk of any country and to identify its risk category. The method applied was based on sound scientific criteria that had been widely published. Moreover, the Scientific Steering Committee relied on an evaluation of the files by external experts. This procedure allowed independent and consistent assessments of all files. Any new relevant scientific evidence could be submitted to the Commission and a re-evaluation could be considered once the additional stability measures had been put in place in a country, after a time span of three to five years to take into account the incubation period of BSE. Since stability factors were not the same for all countries, these had to be considered on a case-by-case basis.

An unstable system implied that recycling or propagation of the BSE agent might occur in the country. Three main stability factors were taken into consideration: (a) whether mammalian proteins had been fed to cattle; (b) what types of rendering was used in the country; and (c) removal of specified risk material. Additionally, other factors such as surveillance and training were considered. In certain cases, although there had been imports of cattle or MBM from affected countries, it had been verifiably demonstrated that these had not entered the feed chain, and the risk remained negligible. However, in countries that had an unstable system, if the BSE agent entered the feed chain, it would be recycled and might be propagated. Therefore, sufficient evidence was needed that no potentially infected animals were rendered. The European Communities considered that the GBR reflected the international standard. The link between the consequences of the new TSE regulation and the experiences from the GBR would be discussed on 18 July (paragraph 4 refers). The European Communities would contribute to work in the OIE framework and remained ready to cooperate with Members and provide information. Knowledge about this disease should be shared to minimize trade effects where possible. All GBRs were available at http://europa.eu.int/comm/food/fs/sc/ssc/outcome_en.html.

In June 2005, the representative of India indicated that the EC categorization of India in the suspected list of the geographical BSE risk assessment (GBR) had been a deep cause of concern. The assumptions made by the European Communities while conducting the risk assessment needed to be reconsidered, as BSE had never been reported in Indian cattle and buffalos. Moreover, feeding practices in India did not allow feed of ruminant origin. India had also provided the European Communities with all the technical information required, including, inter alia, health profiles of imported cattle for the last 20 years. All these facts clearly demonstrated the need to upgrade India's status to GBR 1. India had made these concerns known to the European Communities on several occasions, including at the bilateral meeting held on 28 June 2005. The EC categorization had the potential to disrupt India's beef trade not only with EC member States but also with its other trading partners. India strongly urged the European Communities to undertake the reassessment of India's GBR status as a priority.

The representative of the European Communities replied that the BSE import regime in relation to beef and beef products was proportionate, non-discriminatory and science-based. The recent findings of BSE in both the United States and Canada had not led to measures from the European Communities. The European Communities had put in place a framework which allowed EC member States to trade beef and beef products in accordance with strict scientific criteria. The system had been introduced due to insufficient progress in the OIE with the development of an international framework on trade in beef and beef products and BSE. In that context, the European Communities welcomed the recent agreement in the OIE on a revised Terrestrial Animal Health Code and encouraged all OIE members, including India, to work towards country classifications, which would allow the European Communities to abandon its classification. The representative of the European Communities clarified that India's existing classification would not be revisited since it had been carried out on an independent basis by EC scientists. India was categorized as GBR 2, which was a relatively attractive category allowing trade to take place with minimal safeguard measures. If the OIE failed to classify countries, the European Communities would reconsider the existing classification of third countries, including India. The European Communities sympathised with India's problems in relation to the use of the EC classification system by third countries for their own trade. The European Communities did not encourage such practices by third countries.

In October 2005 and February 2006, the representative of Chile noted that while Chile had never registered any cases of BSE, in 2005 the European Food Safety Authority (EFSA) evaluated Chile as being a country where BSE was likely to occur or had been confirmed (category 3). Chile disagreed with EFSA's analysis, particularly the time-frame and some of the data underpinning the analysis. Chile had sent documentation to EFSA and the European Commission but had not received any reply or comment. EFSA's classification cast doubt on the BSE situation in Chile and had negative impacts on Chile's industry. An ad hoc group of the OIE had noted that Chile satisfied requirements for a country provisionally free of BSE. Chile urged EFSA to recognize the OIE evaluation.

The representative of the European Communities noted that while EFSA had classified Chile as a category 3 risk, the European Communities remained open to reassessing the status in the light of the OIE revised code on BSE. If the OIE were to classify Chile as provisionally free, the European Communities would take this into consideration. However only Argentina, Iceland, Singapore and Uruguay were in this particular category. However, even if a country was categorized as a category 3 risk of BSE, trade could still take place if appropriate measures were in place.

In June 2007, the representative of Canada indicated that his authorities considered both of these specific trade concerns, numbers 96 and 107, to be resolved as they had been overtaken by the OIE's new risk assessment framework and categorization system for BSE risk posed by countries. The EC geographical BSE risk assessment had led to concerns regarding the consistency of the risk analysis and the possibility of reviewing risk assessments over time. The EC transitional TSE measures resulted in the classification of countries according to four levels of risk, but only recognized two levels of risk management. The OIE had made amendments to the Animal Health Code, which updated the risk assessment framework and BSE categorization. As previously reported, Canada was recognized as a controlled risk country for BSE. The European Communities had decided to use the new OIE standards.

The representative of the European Communities noted that the EC measures on BSE had always been intended to be interim measures. The European Communities had clearly indicated that the measures would be adapted in light of OIE standards, but that interim measures were required to to protect health while the OIE completed its work. The interim measures had been proportionate, fair and science-based, especially when compared to the measures imposed by other Members. When cases of BSE had occurred in Canada and the United States, the EC measures had not been changed in any way, whereas many other Members had imposed unjustified measures. Now the OIE had completed an excellent job in preparing appropriate standards, and the European Communities had adapted its measures immediately to ensure full conformity with the new OIE standards. This modification had already been notified to the SPS Committee, and the representative noted that the European Communities was the first Member to fully adopt the new OIE Code. Members had voiced their confidence in the international standards earlier, and the European Communities invited all Members to quickly adopt the OIE standards on BSE.