T97-20 Lawrence Bachorik: (301) 827-6242
June 3, 1997
Consumer Hotline: (800) 532-4440
FDA PROHIBITS MAMMALIAN PROTEIN IN SHEEP AND CATTLE FEED
The Food and Drug Administration today announced publication of a final regulation that
prohibits the use of mammalian protein (with certain exceptions) in the manufacture of animal
feeds given to ruminant animals such as cows, sheep and goats. The rule will take effect 60 days
after its publication June 5. The following may be used to answer questions.
This prohibition is a preventive measure designed to protect animals from transmissible
degenerative neurological diseases such as bovine spongiform encephalopathy (BSE) and to
minimize any potential risk to humans. No case of BSE has ever been documented in cattle in the
U.S. But if a case of BSE were ever found here, these measures would prevent the spread of
BSE through feeds by precluding amplification of BSE in U.S. cattle.
In January, FDA proposed a regulation that would have prohibited the feeding of
ruminant protein to other ruminant animals. In a draft rule published April 17, FDA expanded
that prohibition to include nearly all mammalian protein. Like the proposal, however, the final
rule allows the use of products believed to pose a minimal risk of BSE transmission. These
products include blood, blood products, gelatin, milk, milk products, protein derived solely from
swine and equine sources, and inspected meat products which have been offered for human food
and further heat processed for food, such as plate waste from restaurants and other institutions.
By prohibiting nearly all mammalian protein from being used in ruminant feed, FDA
believes it has made the final regulation more practical and effective. Pure pork and pure equine
protein are excluded because these animals are not known to have transmissible spongiform
encephalopathies (TSEs), and because the protein is processed so that it is not contaminated by
potentially infective proteins.
In addition to prohibiting tissues with the potential to spread TSEs such as BSE, the final
regulation also requires process and control systems to ensure that feed for ruminants does not
contain the prohibited mammalian tissue.
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 there and the feeding
to cattle of protein derived from sheep infected with scrapie, another TSE.
Today's final rule caps a period of intense discussion about the most appropriate way to
provide an additional layer of protection against the potential risk from BSE in this country. In
the last year, FDA has sought comment on the best course of action by publishing an Advance
Notice of Proposed Rulemaking, a Proposed Rule and a Draft Rule. The agency has received
more than 1460 formal comments on this issue, and has held two open public meetings to discuss
the most appropriate course of action.
The current state of knowledge concerning TSEs is far from complete. FDA will continue
its close collaboration with the scientific community and with
public health officials, at home and
abroad, on measures to reduce the potential risk of these diseases.
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This is a mirror of the page at HTTP://www.fda.gov/bbs/topics/ANSWERS/ANS00797.html
Federal Register, June 5, 1997: Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed (Final Rule)