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FDA Proposes Barring Some Cattle Parts From Medical Products January 12, 2007

Posted by notapundit in US News.
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DOW JONES NEWSWIRES

The U.S. Food and Drug Administration is proposing to limit certain cattle materials used in some medical products in order to keep them free of the agent thought to cause mad-cow disease, the agency said in a news release late Thursday.

The FDA said this is the latest in a series of safeguards regarding mad-cow disease, also known as bovine spongiform encephalopathy or BSE: barring material that is known to have the highest concentrations of prions, the fatal agent in infected cattle.

These materials wouldn’t be available for use as ingredients in medical products or elements of product manufacturing. BSE is a degenerative disease affecting the central nervous system of cattle and is caused by a prion, an infectious protein.

The proposed rule would cover drugs, biologics – such as vaccines – and medical devices intended for use in humans, as well as drugs intended for use in ruminant animals like cattle and sheep, the FDA said. Cattle can get mad-cow disease, while sheep can get a similar disease known as scrapie.

“These measures build on a series of barriers FDA and the U.S. Department of Agriculture have erected to further protect humans from exposure to the fatal agent linked to BSE. This proposed rule adds one more safeguard that will reduce the risk of transmission even further,” said Andrew von Eschenbach, commissioner food and drugs, in the release.

The cattle materials prohibited in the proposed rule are those that pose the highest risk of containing infectious material and include: the brain, skull, eyes and spinal cords from cattle 30 months and older; the tonsils and a portion of the small intestines from all cattle regardless of their age or health; any material from “downer” cattle – those that cannot walk; any material from cattle not inspected and passed for human consumption; fetal calf serum if appropriate procedures haven’t been followed to prevent contamination by materials prohibited by this proposed rule; tallow that contains more than 0.15% insoluble impurities if the tallow is derived from materials prohibited by this proposed rule; and mechanically separated beef.

In its proposal, the FDA would require companies keep records to show that any cattle material used as an ingredient in these medical products or as part of their manufacturing process meet the rule’s requirements.

Research supports a link between mad-cow disease and a human illness called variant Creutzfeldt-Jakob disease.

The human disease was first reported in the U.K. in 1996 and is a rare, degenerative, fatal brain disorder. A large outbreak of vCJD in the U.K. in the late 1990s was tied to feed contaminated with infected cattle parts. Since then, a worldwide ban on supplementing feed rations with cattle proteins was instituted.

In 1997, the FDA banned supplement feed rations with cattle proteins, and in 2005, a final rule bans the use of certain high-risk cattle material in food, dietary supplements and cosmetics.

About 200 cases of vCJD have been identified worldwide, including three cases in the U.S. However, there is no evidence that those three patients contracted the disease in the U.S.

By Debbie Carlson, Dow Jones Newswires

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