Final rule adds layer of protection against BSE

Published on June 01, 2008
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To further strengthen existing safeguards against bovine spongiform encephalopathy, the Food and Drug Administration has issued a rule amending its regulations to prohibit the use of certain cattle-origin materials in the food or feed of all animals.

Previously the U.S. ruminant feed regulation prohibited the use of certain mammalian-origin proteins in ruminant feed but allowed them in feed for nonruminant animals.

The final rule becomes effective April 27, 2009, one year after publication in the April 25 Federal Register. (The 12-month implementation period is needed to allow the livestock, meat, rendering, and feed industries time to adapt their practices to comply with the new regulation.) In crafting the rule, the FDA considered more than 840 comments it received following publication of the proposed rule Oct. 6, 2005.

Dr. Bernadette Dunham, director of the FDA Center for Veterinary Medicine, told JAVMA, "The combination of the 1997 and the 2008 BSE rules further protects the U.S. cattle population from the already low risk of BSE. The rule protects animals and consumers against BSE by prohibiting the use of most mammalian protein in the manufacture of animal feeds given to ruminant animals and by removing high-risk materials from all animal feed."

Materials prohibited in all animal feed by the new regulation include the following:

  • the entire carcass of BSE-positive cattle
  • the brains and spinal cords from cattle 30 months of age and older
  • the entire carcass of cattle not inspected and passed for human consumption that are 30 months of age or older from which brains and spinal cords were not removed
  • tallow that is derived from BSE-positive cattle
  • tallow that is derived from other materials prohibited by this rule that contains more than 0.15 percent insoluble impurities
  • mechanically separated beef that is derived from the materials prohibited by this rule

Dr. Gatz Riddell, executive vice president of the American Association of Bovine Practitioners, said, "The most recent regulation will serve to prevent any accidental feeding of (high-risk) ingredients to cattle which might have previously been contained in feeds intended for other species. The rendering and feed industries will bear the majority of the changes imposed by this additional safeguard but the impact should realistically be negligible.

"This regulation is yet another preventative measure to ensure the wholesomeness of animal feeds and safeguard against BSE transmission in the U.S. cattle industry. The additional safeguard will provide assurances to global customers regarding the United States stance on the safety of American beef products."

The April 25, 2008, Federal Register notice summarizes the comments FDA received from many stakeholder groups and the agency's responses. Many comments questioned the need for these additional controls, given the high compliance with the FDA's 1997 feed rule and the low prevalence of BSE in this country. On the other end of the spectrum were stakeholders who favored a ban on all ruminant-derived material in all animal feed. Other concerns were related to the increased financial and record-keeping burden; the difficulty of ensuring complete removal of brain and spinal cord from dead cattle; disposal of materials; and adverse effects on humans, animals, and the environment.

On the basis of stakeholder comments, the FDA made modifications before issuing the final rule. A statement was added to specify that the purpose of a new section of the rule is to prohibit use of certain cattle-origin materials in the food or feed of all animals to further reduce the risk of the spread of BSE within the United States.

In the definition of "cattle materials prohibited in animal feed" the rule now includes the entire carcass of BSE-positive cattle. Also, the FDA has prohibited use of the entire carcass of cattle that are 30 months of age or older, that have not been inspected and passed for human consumption, and from which brain and spinal cord have not been effectively removed or otherwise excluded from animal feed.

The rule was further revised to require renderers to develop and maintain written procedures for determining the age of dead cattle and for removing their brains and spinal cords. The procedures must be made available for FDA inspection.

Given international trade obligations, the FDA also added a provision authorizing the agency to designate a country as not being subject to the new requirements in this rule if the country provides sufficient scientific evidence to support its claimed BSE risk status.

In its December 2005 response to the proposed rule, the AVMA had said the proposal achieved a proper balance between BSE risk reduction and negative impacts on the environment (such as carcass disposal) and animal disease surveillance activities. The AVMA expressed concern, however, that the balance may not be appropriate if the estimates and assumptions in the proposal were inaccurate. In the final rule, the FDA explains how those issues are adequately addressed.

Also in its 2005 response, the AVMA had applauded the FDA decision not to prohibit use of blood and blood products such those as in colostrum replacers. Earlier, in response to the FDA's 2004 Advance Notice of Proposed Rulemaking, the Association had summarized the importance of those products for animal health and welfare.

To view the 40-page final rule in the April 25 Federal Register, go to (PDF, 282 Kb).

For further information, contact Dr. Burt Pritchett, Center for Veterinary Medicine (HFV-222), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855; phone, (240) 453-6860; or e-mail, burt [dot] pritchettatfda [dot] hhs [dot] gov.