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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Veterinarian Newsletter March/April 1998 Volume XIII, No II

Preventing Bovine Spongiform Encephalopathy (BSE) should be a high priority for anyone who has a role to play in food safety or animal health, whether it is the renderer of slaughtered animals, livestock producer, feed manufacturer, or any person in between. One way to help ensure that BSE does not occur in the U.S. is to make everyone acutely aware of their individual responsibility in protecting the public health. It is an educational initiative which must involve all levels of FDA's internal and external customers.

BSE has had a devastating effect on the cattle and rendering industries in the United Kingdom where it was first diagnosed in 1986. BSE poses a serious risk to human health, as well as animal health, since recent evidence has shown a strong link between BSE and the occurrence of new variant Creutzfeldt-Jacob Disease. On August 4, 1997, the regulation published under 21 CFR 589.2000 became effective. This regulation is designed to prevent the establishment and amplification of undetected BSE, often referred to as "Mad Cow Disease," through animal feed by prohibiting the use of certain proteins derived from mammalian tissue in feeding ruminant animals.

FDA is expecting 100 percent compliance with this new regulation, which affects renderers, protein blenders, feed manufacturers including FDA-licensed manufacturers, all other commercial feed manufacturers, distributors including retailers, on-farm feed mixers, and ruminant feeders. On January 29, 1998, CVM issued a nationwide assignment to all FDA field offices to implement our enforcement approach of education, a strong inspectional presence, and taking selected enforcement actions for repeated and/or egregious violations. State governments will cooperate in this effort, and in many cases, have already undertaken educational initiatives related to this regulation.

The assignment includes: 1) inspecting firms in each affected segment of the industry, and 2) tracing shipments forward and backward in the chain from renderer to producer, to verify that prohibited material is properly labeled and used. FDA expects that as close to 100 percent of the affected parties as possible will be inspected in the next two years. These inspections will provide an opportunity to educate the affected industries, measure the extent of compliance, and identify areas that may need additional educational focus.