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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:
• 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;
• An interim final FDA rule that prohibits the use of certain cattle-derived materials in human food (including dietary supplements) and cosmetics; and
• 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," 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 ANPR 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 rules.

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:
• 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;
• requiring dedicated equipment or facilities for handling and storing feed and ingredients during manufacturing and transportation, to prevent cross contamination;
• prohibiting the use of all mammalian and poultry protein in ruminant feed, to prevent cross contamination; and
• 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.

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