HHS NEWS

P97-1                           Food and Drug Administration
FOR IMMEDIATE RELEASE           Lawrence Bachorik: (301) 827-6242
January 2, 1997                 
                                Consumer Hotline:  (800) 532-4440
 
FDA PROPOSES PRECAUTIONARY BAN AGAINST RUMINANT-TO-RUMINANT FEEDING
 
     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.
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