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

In this amended proposal for a Council Regulation laying down rules for the prevention and control of certain transmissable spongiform encephalopathies, the Commission accepted 40 of the European Parliament's 51 amendments in full, in part or after reformulation. Against this background, the main changes to the original proposal relate to the following: - comitology: the originally proposed use of the manangement procedure for adopting implementing measures has been replaced by the regulatory procedure in accordance with Council Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission; - epidemio-surveillance and use of rapid tests for the detection of TSEs: one of the main issues raised by the European Parliament relates to a wider but responsible use of rapid post-mortem tests and this has been acknowledged in the amended proposal. The need to define all ruminant fallen stock (dead-on-farm animas) as BSE suspect animals, has been debated. The amended proposal extends the definition of suspect animals to include only those fallen and emergency slaughtered animals that have tested positive in the monitoring programme is seen as a balanced and justified public health measure. The definition of suspect animals requested by the Council is also clarified. Furthermore, a definition of the rapid diagnostic test has been introduced. However, the text has been slightly reformulated to create the possibility for delegating the evaluation, not the approval, of such tests to an external body if such a need would arise in future. A further important principle when laying down rules for the use of rapid tests, is their statutory approval for each distinct purpose by the Commission through a regulatory procedure. This condition following good legal practice has been introduced in all articles referring to rapid, diagnostic tests, rather than both its definition and the related articles as requested by the European Parliament. Finally, other amendments relate to the monitoring of TSEs providing for use of the rapid tests in the annual monitoring programmes, and of implementing rules reinforcing the protocol for confirming the disease by laboratory tests; - classification of countries according to BSE status: the amended proposal now more clearly recognises the relevance of the BSE criteria and risk factors recommended by the OIE. Moreover, a link has been established with the results of the annual monitoring programme by use of the rapid test and the possibility has been created to require statistically valid large-scale sampling in those circumstances where doubt exists on the BSE status of countries; - specified risk material (SRM): a review under a comitology procedure of the age limits for SRM (i.e the animal tissues being most at risk of harbouring the agent) removal in view of the statisitcal probability of the occurrence of BSE in the slaughter population has been introduced. However, the restraint of an annual review and the proposed deadline for the first review of 01.01.2001 has been changed into 'regular' reviews. The principles of granting derogations from the provisions on SRM removal in high risk areas and for taking account of an effective feed ban, is brought under co-decision; - feed ban: the extension of the feed ban has been brought under the comitology procedure but the text in the Annex has been reformulated to allow for extending the feed ban regardless of BSE status of the country concerned. Another amendment ensures that the feed ingredients banned for feeding are also not stored, dispatched or imported. Finally, it is proposed to derogate gelatine derived from hides and skins from the ban, but to extend the ban to feeding bovine blood products to ruminants; - disease eradication: a requirement has been added providing for an obligation for the Member States to inform the Commission of all TSE suspect cases on a regular basis. Furthermore, the European Parliament's amendments suggesting whole herd slaughter for BSE in cattle have been taken into account on condition that derogation is possible in those cases where the Commission under a Comitology procedure has approved equivalent measures; - conditions for marketing animals: the duration of the 'scrapie-free' period has been extended; - various: these amendments include an exception from the ban on certain slaughter techniques only granted in BSE free countries and finally, live animals for research have been excluded from the scope of the proposal.�