FDA Proposes Additional Feed Regulations

October 4, 2005 - 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). 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.

In a media conference call, Dr. Stephen Sundlof, director, FDA's Center for Veterinary Medicine, said the amount of proposed prohibited material is "relatively small," about 64.3 million pounds. In an advanced notice of proposed rulemaking (ANPR) released jointly by FDA and the U.S. Department of Agriculture in July 2004, the agency proposed banning an estimated 2.1 billion pounds of specified risk materials (SRMs) in all animal feed. Sundlof explained that SRMs have a different definition by USDA than the "cattle materials prohibited from animal feeds" addressed in this new proposed regulation.

In the July 2004 ANPR, FDA asked for comments on banning SRMs in all animal feed and also on other feed control measures such as prohibiting the use of all mammalian and poultry protein in ruminant feed. The agency also asked for comments 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 carefully analyzed the comments it received on the 2004 ANPR and concluded that the other feed control measures discussed in the ANPR are not needed if the high-risk tissues identified in this proposed rule are excluded from all animal feed channels. According to Sundlof, the proposed rule released today will remove 90 percent of infectivity possible in animal feed and will apply mostly to renderers.

Today's proposed regulation builds on a series of firewalls that include FDA's 1997 feed regulation that 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. According to FDA, 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.

Comments on the proposed rule will be due 75 days following publication in the Federal Register, or December 19, 2005. The proposed rule can be found here.


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