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Date:  January 2, 1997
FOR IMMEDIATE RELEASE
Contact:  FDA Press Office (Lawrence Bachorik): (301) 443-1130
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The Food and Drug Administration today proposed to prohibit using tissues from ruminants -- animals such as cows, sheep and goats -- in the manufacture of ruminant feeds. Mink tissue would also be prohibited from such feeds.

The proposed regulation is the latest in a series of preventive measures -- including a voluntary industry moratorium -- that FDA, other federal agencies and industry have already taken to protect animals from transmissible degenerative neurological diseases, and to minimize any potential risk that such diseases could be transmitted from animals to humans.

These animal diseases are known as transmissible spongiform encephalopathies (TSEs). Bovine spongiform encephalopathy (BSE) is among the more commonly known of these diseases. TSEs are characterized by a long incubation period, a relatively short clinical course of neurological signs, and 100 percent mortality. Because of concerns that BSE could in the future be identified scientifically as the cause of a new TSE in humans, FDA and USDA officials said the protection of public health depends on the development of a strategy to control possible routes of TSE expansion in food animals.

FDA's proposed regulation would prohibit the use of nearly all potential sources of ruminant and mink protein in feed intended for ruminants. The only exceptions would be bovine blood, ruminant-derived milk and gelatin, since FDA has no information suggesting that milk proteins, gelatin or bovine blood proteins are potentially infective for TSEs.

"This is a precautionary measure -- there have been no reported cases of BSE in this county," said Donna E. Shalala, Secretary of Health and Human Services. "It will add another level of safeguards to protect the U.S. against the potential risk from these diseases."

"If for some reason a case of BSE were to occur in the U.S. -- and it is important to emphasize that not even one case of BSE has ever been found here -- the steps we are taking today would confine it to the individual animal and greatly decrease the potential risk to humans," said FDA Commissioner David A. Kessler, M.D. "In essence, this proposal would build a protective barrier against the spread of BSE."

In addition to prohibiting tissues with the potential to spread TSEs, the proposed rule also requires process and control systems to ensure that ruminant feed does not contain the prohibited tissues.

The first case of BSE was reported in the United Kingdom in 1986. Epidemiological evidence gathered in the U.K. suggests an association between the outbreak of BSE there and the feeding to cattle of protein derived from sheep infected with scrapie, another TSE.

Recently, scientists have postulated an association between BSE and a variant form of Creutzfeldt-Jakob Disease (v-CJD) reported in the U.K. Creutzfeldt-Jakob Disease is a degenerative neurological disorder that affects humans.

The British government on March 20 announced a possible link between BSE and 10 cases of v-CJD. Nine days later, U.S. national livestock organizations and professional health groups announced a voluntary moratorium on the use of ruminant protein in feeds of ruminants. At the same time, FDA committed to expediting regulations addressing issues related to feeding ruminant protein, and on May 14 the FDA published an Advance Notice of Proposed Rulemaking to solicit scientific and economic information and other public comments.

Today's proposed regulation is the product of FDA's evaluation of this information to date. FDA will continue to evaluate additional data and comments related to this proposal.