The U.S. Food and Drug Administration (FDA) today announced new measures to help further protect consumers against the agent thought to cause bovine spongiform encephalopathy (BSE, also known as "mad cow disease"). The Agency is proposing to amend its animal feed regulations to prohibit from use in the food or feed of all animals certain high risk cattle materials that can potentially carry the BSE-infectious agent. All of the proposed prohibitions, except for those related to tallow, have already applied to cattle feed since 1997.
"These additional measures that we proposed today will make an already small risk even smaller by further strengthening the effective measures already in place to protect American consumers from BSE," said Acting FDA Commissioner Dr. Andrew von Eschenbach.
These high risk cattle materials prohibited in the new proposed rule include:
· the brains and spinal cords from cattle 30 months of age and older,
· the brains and spinal cords from cattle of any age not inspected and passed for human consumption,
· the entire carcass of cattle not inspected and passed for human consumption if the brains and spinal cords have not been removed,
· tallow that is derived from the materials prohibited by this proposed rule if the tallow contains more than 0.15 percent insoluble impurities,
· mechanically separated beef that is derived from the materials prohibited by this proposed rule.
Today's proposed regulation builds on a series of firewalls that include FDA's 1997 feed regulation which prohibits the use of certain mammalian-origin proteins in ruminant feed (e.g. for cattle and sheep), but allows these materials to be used in feed for non-ruminant species. The removal of high-risk materials from all animal feed, including pet food, will protect against the transmission of the agent of BSE that could occur either through cross-contamination of ruminant feed with non-ruminant feed or feed ingredients during feed manufacture and transport, or intentional or unintentional misfeeding of non-ruminant feed to ruminants on the farm.
In July 2004, FDA and USDA jointly published an Advance Notice of Proposed Rulemaking (ANPRM) in which FDA announced its tentative conclusion that it should propose banning SRMs in all animal feed. In this ANPRM, FDA asked for comment on this measure and also on other feed control measures such as prohibiting the use of all mammalian and poultry protein in ruminant feed.
FDA also asked for comment on the set of measures that the agency had announced in January 2004 including the elimination of the exemptions for blood and blood products and "plate waste" from the 1997 ruminant feed rule, a prohibition on the use of poultry litter in ruminant feed, and a requirement for dedicated equipment and facilities to prevent cross-contamination.
FDA has carefully analyzed the comments it received on the 2004 ANPRM and has concluded that the other feed control measures discussed in the ANPRM are not needed if the high-risk tissues identified in this proposed rule are excluded from all animal feed channels.
Comprehensive information about FDA's work on BSE and links to other related websites are available at http://www.fda.gov/oc/opacom/hottopics/bse.html.