Prevention, control and eradication of certain transmissible spongiform encephalopathies (TSEs)

PURPOSE: to lay down rules regarding the effective surveillance of transmissible spongiform encephalopathies (TSEs) based on Article 100A. CONTENT: The main objective of the proposal is to create the legal base for the control and prevention of all animal TSEs and for all products, including those not covered by Annex II of the Treaty. the articles of the proposal provide the necessary instruments to reach this goal and in the Annexes the details are worked out as far as possible according to current knowledge. Implementing rules are foreseen where future action can be expected. The provisions are based on the OIE recommendations on BSE and the various scientific opinions available in order to ensure a very high level of protection. In principle, the prevention and control of all animal TSEs with respect to food and feed is covered. Industrial, cosmetic and medicinal products, medical devices and products destined for research, exhibitions and teaching are not included, because there is either no inherent risk for human or animal health or the provisions are covered by sectoral legislation. A general provision to ensure that those products, which are not covered by the Regulation, cannot enter the food and feed chains provides the necessary protection during the production process. An important exception to the above is the exclusion of the animal waste legislation despite the fact that the predominant motivation for this legislation is protection against TSEs. For technical reasons, it was considered beneficial to keep the animal waste legislation separate as a coherent independent set of legislation. The elements of this legislation, such as waste processing standards, validation of processes, approval of establishments, placing on the market of rendered prodcust, etc. are strongly interdependent and form a coherent entity. moreover they are primarily based on general hygiene standards. It is proposed to treat national trade, intr-Community trade, import and export in an equivalent manner. All existing Community rules on TSEs are incorporated in the proposal including preventive measures e.g. feed and SRM bans. A legal base is created for eradication of all TSEs, including scrapie and BSE in sheep, and for trade requirements preventing the spread of BSE by movements of live bovine, ovine and caprine animals. In the absence of scientific advice and international standards on the eradication of scrapie, or on trade rules to prevent the spread of BSE through sheep, no detailed rules are proposed in these areas. The same would apply to eradication of BSE in sheep but following the precautionary principle and the serious consequences of the possible establishment of a BSE reservoir in sheep, detailed rules for BSE eradication in sheep are proposed nevertheless. Community rules for the movement of live breeding sheep and goats related to scrapie already exist. These have been transposed to this proposal, with the exception of the current option for Member States to demand additional guarantees on the basis of a Community approved scrapie control programme. In the past, a policy decision was taken not to proceed withthe approval of national programmes and the subsequent granting of additional guarantees beyond the limited list of diseases for which programmes had already been approved. It was felt that the accumulation of national programmes and additional guarantees would constitute an unjustified barrier to trade and disrupt the internal market. The aforementioned list dopes not include scrapie. Since the proposal at hand has as its objective to harmonise all trade rules relating to TSEs, including scrapie, and offers the legal base for eradication of scrapie, there is no longer a need for nationam programmes for scrapie control. For implementing rules, the management procedure is proposed; for new rules, and amendment of the Annexes, the Regulatory procedure is proposed. This is considered appropriate to give the Commission the necessary tools to 'manage' the BSE crisis.�