July 9, 2004
FDA and USDA Request Comments and Scientific Information on Possible New BSE Safeguards
Today, the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) announced that they will publish an advance notice of proposed rulemaking ( ANPRM ) -- that requests comments and scientific information on several additional measures related to animal feed under consideration to help prevent the spread of bovine spongiform encephalopathy (BSE, also known as “Mad Cow Disease”) in the United States. Some of these measures include:
removing specified risk materials (SRMs) from all animal feed, including pet food, in order 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 tentatively concluded that it should propose to remove SRMs from all animal feed and is currently working on a proposal to accomplish this goal. Comments on the issues raised by FDA in the ANPRM are due to FDA 30 days after they publish in the Federal Register.
FDA’s 1997 ruminant feed rule has been a 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.
After a BSE-positive cow was detected in late December 2003, FDA announced its plans to publish interim final rules on BSE that would take effect immediately upon publication. For animal feed, FDA stated that the rule would eliminate the present exemption in the ruminant feed rule that allows mammalian blood and blood products to be fed to other ruminants as a protein source, ban the use of "poultry litter" as a feed ingredient for ruminant animals, and ban the use of "plate waste" as a feed ingredient for ruminants. In addition, FDA said that to further minimize the possibility of cross-contamination of ruminant and non-ruminant animal feed, the rule would require equipment, facilities, or production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed.
On February 4, 2004 , shortly after FDA announced its plans to publish interim final rules on BSE, an International Review Team (IRT) convened by USDA issued a report and additional actions to protect the public against BSE.
The proposed actions were significantly different from those FDA announced in late January. Some of those proposals would make some of FDA’s actions unnecessary. Rather than publishing a regulation that would take effect automatically, USDA and FDA are soliciting public comment on the IRT’s suggestions, as well as other measures designed to protect North America against BSE. By seeking comment on the IRT’s recommendations, the agencies hope to put into effect the most comprehensive, science-based improvements possible.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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