News Release
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FOR IMMEDIATE RELEASE Friday, July 9, 2004 |
Contact: FSIS Press Office (202) 401-4541
APHIS Press Office (301) 734-7799
FDA Media Relations (301) 827-6242 |
USDA and HHS Strengthen Safeguards Against Bovine Spongiform Encephalopathy
HHS Secretary Tommy G. Thompson and Agriculture Secretary Ann M.
Veneman today announced three actions being taken to further
strengthen existing safeguards that protect consumers against the
agent that causes bovine spongiform encephalopathy (BSE, also known
as “mad cow disease”).
The three documents on display today include:
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A joint USDA Food Safety & Inspection Service (FSIS), USDA
Animal and Plant Health Inspection Service (APHIS) and Food and
Drug Administration (FDA) notice that asks for public comment on
additional preventive actions that are being considered
concerning BSE;
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An interim final FDA rule that prohibits the use of certain
cattle-derived materials human food (including dietary
supplements) and cosmetics; and
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A proposed FDA rule on recordkeeping requirements for the
interim final rule relating to this ban.
“Today’s actions continue our strong commitment to
public health protections against BSE,” Secretary Thompson
said. “Although our current rules are strong, when it comes
to public health and safety we cannot be content with the status
quo. We must continue to make sure the public is
protected to the greatest extent possible.”
“This administration is committed to science-based measures
to enhance and protect public health,” Secretary Veneman
said. “The advance notice of proposed rulemaking will
allow the public the opportunity to provide their
input.”
“The series of firewalls already in place offer excellent
protection against BSE,” said Acting Commissioner of the Food
and Drug Administration, Dr. Lester M. Crawford. “With
these additional measures, we will make a strong system even
stronger by putting into effect the most comprehensive,
science-based improvements possible.”
The steps already taken have been effective in protecting the
American consumer from exposure to BSE. Import controls on
live cattle and certain ruminant products were put in place more
than 15 years ago. In 1997, FDA finalized its animal
feed ban, which has been the critical safeguard to stop the spread
of BSE through the U.S. cattle population by prohibiting the
feeding of most mammalian protein to cattle and other ruminant
animals. USDA implemented additional measures in January to
ensure that no cattle tissues known to be high risk for carrying
the BSE agent are included in USDA-regulated products. Finally, as
became evident last December, there is a contingency response plan,
developed over the past several years, that is launched immediately
to contain any potential damage after a BSE positive animal is
found.
To allow interested parties and stakeholders the opportunity to
comment on the additional regulatory and policy measures under
consideration, USDA’s APHIS and FSIS, along with the FDA,
developed an advance notice of proposed rulemaking that includes
several additional actions the federal government is considering
regarding BSE.
The Advance Notice of Proposed Rulemaking (ANPRM) also provides the
public a succinct report on the work of the international review
team (IRT) convened by Secretary Veneman to review the U.S.
response to the single case of BSE in the United States (in a cow
imported from Canada), along with a summary of the many actions
already taken by each agency on BSE.
USDA’s FSIS continues to seek and address comments on actions
taken in relation to the BSE mitigation measures and put in place
in January 2004. FSIS is also specifically seeking comments
on whether a country's BSE status should be taken into account
when determining whether a country’s meat inspection system
is equivalent to the U.S. regulations including the provisions in
the FSIS interim final rule.
USDA’s APHIS is specifically seeking comments on the
implementation of a national animal identification system. In
April, USDA announced the availability of $18 million in Commodity
Credit Corporation funding to expedite development of a national
animal identification system, which is currently underway.
APHIS is inviting comments on when and under what circumstances the
program should move from voluntary to mandatory, and which species
should be covered now and over the long term.
The ANPRM also requests comment on the following measures related
to animal feed, which is regulated by FDA:
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removing specified risk materials (SRM’s) from all animal
feed, including pet food, to control the risks of cross
contamination throughout feed manufacture and distribution and on
the farm due to misfeeding;
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requiring dedicated equipment or facilities for handling and
storing feed and ingredients during manufacturing and
transportation, to prevent cross contamination;
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prohibiting the use of all mammalian and poultry protein in
ruminant feed, to prevent cross contamination; and
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prohibiting materials from non-ambulatory disabled cattle and dead
stock from use in all animal feed.
FDA has reached a preliminary conclusion that it should propose to
remove SRM’s from all animal feed and is currently working on
a proposal to accomplish this goal. Comments on these issues raised
in the ANPRM are due to FDA next month.
FDA today also issued an interim final rule that prohibits the use
of cattle-derived materials that can carry the BSE-infectious agent
in human foods, including certain meat-based products
and dietary supplements, and in cosmetics. These
high–risk cattle-derived materials include SRM’s that
are known to harbor concentrations of the infectious agent for BSE,
such as the brain, skull, eyes, and spinal cord of cattle 30 months
of age or older, and a portion of the small intestine and tonsils
from all cattle, regardless of their age. Prohibited
high-risk bovine materials also include material from
non-ambulatory disabled cattle, the small intestine of all cattle,
material from cattle not inspected and passed for human
consumption, and mechanically separated beef.
This action is consistent with the recent interim final rule issued
by USDA declaring these materials to be inedible (unfit for human
food) and prohibiting their use as human food.
FDA’s interim final rule, in conjunction with interim final
rules issued by FSIS in January 2004, will minimize human exposure
to materials that scientific studies have demonstrated are likely
to contain the BSE agent when derived from cattle that are infected
with the disease. Consumption of products contaminated with
the agent that causes BSE is the likely cause of a similar disease
in people called variant Creutzfeldt-Jakob disease.
Although FDA’s interim final rule has the full force
and effect of law and takes effect immediately upon publication in
the Federal Register, FDA is also asking for public comment
on it.
In conjunction with the publication of the interim final rule, FDA
is also proposing to require that manufacturers and processors of
FDA-regulated human food and cosmetics containing cattle-derived
material maintain records showing that prohibited materials are not
used in their products. FDA is taking this action because records
documenting the absence of such materials are important to ensure
compliance with requirements of the interim final
rule.
Publication of this USDA-FDA notice, as well as the two FDA
documents, is scheduled for mid-July in the Federal
Register.
Comments should be submitted as directed in the addresses section
of each document. Each document also provides information
about how and where comments received may be viewed.
Note to Reporters: USDA news releases, program announcements and
media advisories are available on the Internet. Go to the
APHIS home page at http://www.aphis.usda.gov and click on the
“News” button.
HHS news releases are available online at www.hhs.gov; FDA news releases can be
found at www.fda.gov, which will
also provide links to the documents discussed in this release.
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Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.
Last Revised: July 9, 2004