STC Number - 31

Rules on "specified risk materials" in products of animal origin

Maintained by: European Union
Raised by: United States of America
Supported by: Argentina; Australia; Brazil; Canada; Chile; Colombia; Czech Republic; Mexico; New Zealand; Switzerland; Uruguay
First date raised: October 1997 G/SPS/R/9/Rev.1 (EN), paras. 10-14 ; G/SPS/R/9 (FR, ES), paras. 10-14
Dates subsequently raised: March 1998 (G/SPS/R/10 paras. 13-19)
June 1998 (G/SPS/R/11 paras. 34-38)
July 2001 (G/SPS/R/22 para. 127)
Number of times subsequently raised: 3
Relevant documents: G/SPS/GEN/36 G/SPS/GEN/45 G/SPS/GEN/67 G/SPS/GEN/265
Products covered: 30 Pharmaceutical products; 0511 Animal products not elsewhere specified or included; dead animals of Chapter 1 or 3, unfit for human consumption.; 1516 Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinized, whether or not refined, but not further prepared.
Primary subject keyword: Animal Health
Keywords: Animal health; Human health; International Standards / Harmonization; Zoonoses; Bovine Spongiform Encephalopathy (BSE)
Status: Not reported
Solution:
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

In October 1997, the representative of the United States informed the Committee of his authorities' concerns with both the public health and the trade implications of the EC Decision 97/534 EC, which banned the use of certain specified risk materials in a wide range of products (G/SPS/GEN/36 refers). He noted that public health agencies were concerned that the EC decision, if implemented as originally drafted, might directly or indirectly cause international shortages of needed medical products, which could adversely affect the health of consumers. It could also have a major restrictive impact on Member's trade in tallow, tallow derivatives, gelatine, pharmaceuticals and many food products. The representative of the United States indicated that EC's ban appeared to be more restrictive than necessary to achieve Member's shared public health objectives. By imposing the same restrictions on products sourced from the United States and other regions where BSE is not known to exist as are imposed on products from regions where the presence of BSE is well documented, Decision 97/534/EC did not appear to recognize important difference in regional disease conditions. Canada, Australia, Argentina, Brazil, Uruguay, New Zealand, the Czech Republic, Mexico, Colombia and Chile associated themselves with the concerns expressed by the US representative.

The representative of the European Communities indicated that the EC Commission's decision had followed the opinion of the Scientific Veterinary Committee of October 1996 and had been adopted in July 1997 by the EC Council of Ministers. Following the announcement by the British government in March 1996 of possible transmission of bovine spongiform encephalopathy to humans, scientific evaluation had been intensified in this area. Although there was no proof yet, recent scientific studies had increasingly demonstrated the existence of such possibility. Therefore, the European Communities had decided to increase its level of protection, aiming at reducing the risk, not to zero because this was impossible, but to the minimum. Whereas in the past the European Communities had banned the use of mammalian meat and bone meal to feed ruminants, that feed ban was not effective to insure that the agent would not be transmitted first to the animal population and subsequently eventually to humans through the consumption of infected material. This concern was reflected in the April 1997 decision to reinforce rendering standards.

However, recent inactivation studies had demonstrated that the conditions set by the April decision were not a sufficient safeguard especially in a situation of high degrees of infectivity. This additional uncertainty was taken into account by the "safe-sourcing" principle which consisted of preventing specified risk material which eventually might endanger public health from entering the process by any channel, whether feed, food or cosmetics. In terms of transmissible spongiform encephalopathies (TSE), including BSE, brain, spinal cord and retina were considered to be high risk materials by the European Communities and there were discussions in the EC Multidisciplinary Scientific Committee on whether intestines should also be included in this list. Moreover, the Scientific Committee was considering the need to abolish the 12-month age limit below which there were no prohibitions, implying that all such tissues, irrespective of the age of the animal, would be banned for any use. There were still numerous questions regarding BSE which remained to be answered, and it was for that reason that the EC Commission had decided to take a precautionary approach. The European Communities would respect its international obligations. Any Member which considered itself to be in a situation presenting no risks with regard to TSEs, could present a submission for examination by the EC Scientific Committee. This Committee had already evaluated the applications of certain Members and the EC Commission would consider what action to take in light of this evaluation. The European Communities needed to take into account other TSEs due to the links with BSE and the origin of this disease, believed to have been provoked by the feeding of scrapie-infected material from ovines to the bovine population. However, the origin of the disease might also be endemic in the bovine population and, as a result, recycling could take place through rendering systems which were not effective in de-activating the agent.

The Scientific Committee would also look at the issue of tallow and tallow derivatives in connection with BSE risks, and there was a possibility that, irrespective of the source, tallow derivatives might be characterized as safe provided they were treated under the stringent EC parameters of hydrolysis. The EC Commission was looking at the question of the availability of pharmaceutical products and life-saving types of medicine. However, the representative of the European Communities noted that the SRM ban related strictly to the bovine, ovine and sheep population and, at the moment, only in relation to animals over the age of twelve months. Gelatin or tallow from the porcine species or any other species could be used without difficulty. In addition, the rendering, tallow and gelatine producing industries in Europe were in the process of adjusting to the new requirements which would enter into force on 1 January 1998. Therefore, it was not expected that there would be any lack of available of source materials for the production of life-saving medicines. In the European Communities, products which had been produced with SRMs before 1 January 1998 could not legally be marketed after that date, whether they were of internal or imported origin.

The United States representative indicated that materials from the United States and many other Members did not contain high degrees of infectivity of BSE and that this should be a relevant consideration in this matter. Moreover, whereas it was always possible to comply with any unnecessary measure, one purpose of the SPS Agreement was to avoid having to do so. The representative of Argentina said that his country had first taken a resolution regarding BSE in 1990. He also provided copies of a booklet, which contained a BSE Risk Analysis. In his view, measures which failed to distinguish between countries infected by BSE and countries not infected were contrary to the OIE recommendations and the SPS Agreement.

In March 1998, the representative of the United States recalled the concerns that his and other delegations had expressed in the previous meeting of the Committee with regard to the public health and trade implications of the EC proposed ban on "specified risk materials" (G/SPS/R/9/Rev.1). The United States had since then continued to follow this issue closely and welcomed the EC decision to provide additional time to review all the scientific evidence and other important implications of the proposed measure. The United States was hopeful that the new approach recently proposed by the EC Commission would address the concerns that many Members had raised with respect to this measure. The fundamental view of the United States was that, consistent with Article 6 of the SPS Agreement, the SRM ban should recognize the BSE-free status of the United States and other regions. Products from those regions should not be subject to the ban. There had been no cases of BSE in the United States. Moreover, the United States maintained a rigorous surveillance system and other appropriate measures which surpassed the OIE requirements for establishing BSE-free status.

The representative of Canada indicated that his delegation was also encouraged by the delay in the implementation of the SRM ban and supported the US view that the proposed ban appeared to be moving in the right direction. He also welcomed the EC recognition of differences in the disease status of countries and was encouraged that the EC evaluations were to be based on OIE standards. Canada still had a concern with regard to the EC proposed evaluation process. It was Canada's understanding that the procedure would require a country to answer about 38 questions and that there was a provision in the procedure that when countries were not able to provide an answer because of unavailable scientific information, the EC Scientific Steering Committee would interpret the missing data as a worst case scenario, meaning that assumptions would be used to replace data that was not available. This would have severe implications, and Canada expected that the European Communities would review this provision.

The representative of Australia drew the attention of the Committee to document G/SPS/GEN/45, which contained Australia's comments with regard to the EC SRM ban, and reiterated that his country trusted that the European Communities would appropriately modify the application of this legislation so as not to disrupt trade through placing requirements for the exclusion of SRMs upon countries such as Australia which met agreed international criteria for BSE freedom.

The representative of Brazil noted that Brazilian exports of edible gelatine had been affected by the French decision to impose a specific requirement on all gelatine imports. Brazilian exports to that country had consequently decreased significantly. There was no scientific basis for applying such a decision to countries free of BSE, as was the case of Brazil. The French measure lacked scientific evidence, did not take into account the different status of different regions, and was not in line with Articles 2.2 and 5.6 of the SPS Agreement. It should also be carefully designed on the basis of sound science to effectively address its main concern, public health, and avoid unnecessary disruptions in the supply of safe products. She stressed that BSE had never been registered in the Brazilian territory. The Brazilian Ministry of Agriculture and Food Supply had approved a regulation, which followed the criteria established in Chapter 3.2.13.2 of the OIE Code, recognizing not only that Brazil was free of BSE, but also established specific rules of surveillance and procedures for notification of any suspicious cases of BSE and scrapie (G/SPS/GEN/67). Moreover, caprine and ovine populations were very limited in the Brazilian territory. The Ministry had also prohibited, by means of internal regulation, the feeding of bovine populations with protein of ruminants, with the exception of milk. The same rule applied to imported feedstuffs from ruminant. The Brazilian Animal Health Department conducted continuous surveillance of rabies and other nervous-system diseases of the whole national territory and to date no cases had been diagnosed. Brazil had not imported bovine, caprine and wild animals from BSE-infected countries since 1990. In the case of sheep, the prohibition was effective since 1995. Regarding market access problems faced by Brazilian producers of gelatine, she noted that the raw material employed in the preparation of gelatine had been classified by the OIE as having low risk of transmission of BSE, even in regions where the disease had been notified. The Brazilian product was submitted to temperatures that reached 140°C at different stages of its preparation as required by France. The Brazilian representative stressed that she expected that this information would expedite the removal of unnecessary barriers applied to Brazilian gelatine. She indicated that the EC questionnaire requesting information regarding the rules and composition of animal feeding in Brazil would soon be officially provided to the European authorities.

The representative of Argentina supported the comments by Canada, Australia and Brazil.

The representative of the European Communities indicated that as a consequence of internal discussions and representations made by third countries, the Commission had decided and the Standing Veterinary Committee had approved postponing the application of the SRM decision to enter into force on 1 April 1998. The scientific discussions continued in the European Communities and new scientific evidence had been received from the United Kingdom BSE Advisory Committee with regard to dorsal root ganglia, bone marrow, etc. The outcome of that evaluation had resulted in the EC proposal which was being discussed in the European Communities. The proposal suggested that, instead of having measures in place by 1 April 1998, a further period of transition was necessary and the new requirements would apply as from 1 July 1998. An enlarged list of specified risk materials, including dorsal root ganglia, bone marrow and other intestines, would be included in the provisions. However, if an EC member State or a third country submitted an application for a derogation, this derogation would be rapidly evaluated by the Commission, so that the application of such measures would not enter into force until 1 January 1999. A precondition for the derogation would be the absence of BSE, no native cases of BSE, and the procedure would be within the Scientific Steering Committee and the Scientific Veterinary Committee. A number of submissions had already been received and the Commission expected to receive further submissions in the near future. If there were native cases, like in Switzerland, such countries must apply from 1 July 1998 the short list SRM removal as reflected in the OIE Code. The geographical risk factors would thus be taken into account: there would be different provisions in place or no provisions in place depending on the submission and evaluation by the EC scientists. Ireland and Switzerland were also working on post-mortem methodologies to detect BSE, which might one day become useful tools. However, the Standing Veterinary Committee had not approved the EC proposal by the required qualified majority. The decision was now dependent on the Council of Ministers. The EC representative stressed that, unlike the United States, the European Communities had focused on the parts of the bovine body which had been scientifically identified as containing, or potentially containing the agent, but had never targeted meat as such. In response to the Brazilian statement, he indicated that the provisions in place by France mirrored those for the United Kingdom. Harmonized rules were being discussed in the European Communities, but BSE as such and the question of additional guarantees with regard to Brazil or other countries should be addressed within the framework of the requests for derogations from the expected SRM decision. In response to a question raised by Brazil, he added that if the production was based on skulls, where brain material could be connected, or the vertebral column, where spinal cord could be connected, the issue would be problematic. However, if Brazil could certify that, as claimed, all its production of gelatine was based on hides from animals fit for human consumption, the difficulties faced by Brazil should be easily solved. Repeating that the European Communities had no harmonized system in place, he noted that the French measures should be considered in that light and suggested that the Brazilian delegate should pursue the issue bilaterally with the representative of France.

The representative of Uruguay informed the Committee that Uruguay had been alerted to the fact that the Ministry of Public Health of Italy was restricting or including bovine lungs, or products derived from bovine lungs to be used in the production of pharmaceutical products, in the SRM category. Uruguay was unaware of any EC Commission decision on this issue and noted that this restriction distorted an important Uruguayan trade flow to the European Communities.

In June 1998, the representatives of Argentina, Canada, Chile, Switzerland and the United States sought an update on the BSE-related issue, extensively discussed during the ninth and tenth meetings of the SPS Committee. In particular, these delegations sought information on: (a) the current status of the restriction and the proposed time-frame for implementation; (b) whether the amended version of the regulation would be published and notified to WTO; (c) the criteria on the basis of which a country's BSE-status was to be determined; and (d) how the European Communities would ensure that individual EC member States did not start introducing their own measures.

The representative of the European Communities reported that EC member States were still unable to reach a common position on this issue. Consequently, EC Decision No. 97/934 would not enter into force until 1 January 1999. A suggestion that the list of SRMs be slightly reduced was subject to a scientific review. In the meantime, EC member States, such as the United Kingdom, France, Ireland, Belgium, the Netherlands, Portugal and Luxembourg, had introduced a number of measures. Notification of these national safeguard measures to the WTO had been considered but not yet made. (The concerns expressed by several delegations regarding the lack of notification by EC member States are reported under agenda item 2(c) below.)

The EC representative also reported that the EC Commission was submitting new legislation to the Council for approval, departing from the traditional procedure reserved for safeguards on BSE where the proposal was forwarded to the EC Standing Committee. The legislative proposal would include general provisions in terms of safeguards and control measures with respect to BSE. An important element in elaborating this proposal was the outcome of the recent meeting of the OIE, in particular classification of countries according to four categories of BSE incidence. This would play an important role in the formulation of EC internal policies. On the other hand, the Scientific Veterinary Committee had considered BSE-free status on several occasions and concluded that the United States could not be recognized as BSE-free. This did not mean that BSE was present in US territory, but rather that the country fell into the "low-risk" category, taking into account the presence of risk factors in feeding of meat and bone-meal and in ineffective meat rendering systems, and the absence of an adequate surveillance system in place for a sufficiently long time-period.

The US representative disagreed with the classification of the United States as a "low-risk" country. Furthermore, the United States had not been officially notified of any decision by the European Communities on the disease status of the United States. An official notice to the Chief Veterinary Officer, together with the criteria and scientific basis used by the European Communities to reach this determination, would be most appreciated by the United States. It was the US understanding that the EC Scientific Steering Committee had been unable to date to adopt an opinion on third country BSE-status because of lack of relevant data. The United States was currently preparing a new submission and requested clarification as to whether the Commission was prepared to consider new information in order to reassess its criteria and its application to individual countries. Information on the criteria used by the Commission to carry out its evaluation and deadlines for receipt of submissions was also requested.

The EC representative clarified that, in their view, no country could be designated as BSE-free as such, and confirmed that the Commission had not reached any conclusions with regard to provisions of the directive whose application was suspended until 1 January 1999. This was also the deadline for receipt of submissions. The revision and evaluation procedure was ongoing, and countries should submit further background information. For example, information required to be eligible for a derogation from EC measures was whether the adequate risk management measures were in place. Applications had already been received from a number of EC member States, and Argentina, Australia, Canada, Chile, United States, Japan, New Zealand and the Czech Republic. The EC delegation invited other Members which considered themselves eligible for derogations or less stringent requirements to also send their applications to the Directorate General for Agriculture (DG VI).

In July 2001, the representative of the United States introduced an update to the Secretariat document on specific trade concerns (G/SPS/GEN/204/Rev.1). The United States had examined the issues it had raised in the Committee to determine whether the issues had been resolved. This exercise had shown that the SPS Committee was a useful forum to address and resolve trade issues. The US document presented the US view on the status of the relevant issues, and the United States was prepared to discuss other Members' views on this status.