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FDA Proposes Additional BSE Safeguards


Oct. 4, 2005 — The U.S. Food and Drug Administration (FDA) today announced new measures tightening feed regulations designed to prevent the spread of agents thought to cause bovine spongiform encephalopathy (BSE). The agency proposes amending its animal feed regulations to prohibit certain high-risk cattle materials — that could potentially carry the BSE-infectious agent — from use in the food or feed of all animals. All of the proposed prohibitions, except for those related to tallow, have already applied to cattle feed since 1997. With the proposed changes, high risk materials will be prohibited from all animal feed, including pet food.

“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.

Steve Sundlof, FDA director for the Center for Veterinary Medicine, said the new measures to remove certain cattle materials would remove 90% of BSE-related risks present in non-ruminant feeds.

High-risk cattle materials prohibited in the new proposed rule include:

• brains and spinal cords from cattle 30 months of age and older;
• brains and spinal cords from cattle of any age not inspected and passed for human consumption;
• 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% insoluble impurities; and
• mechanically separated beef that is derived from the materials prohibited by this proposed rule.

According to FDA, today’s proposed regulation builds on a series of firewalls that include the agency’s 1997 feed regulation, which prohibited the use of certain mammalian-origin proteins in ruminant feed (e.g. for cattle and sheep), but allowed these materials to be used in feed for non-ruminant species. The removal of high-risk materials from all animal feed, FDA officials stated, 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.

During a press conference, Sundlof said disposing of the 64.3 million pounds (lb.) of high-risk materials from all animal feed would cost approximately $14 million per year.
Sundlof noted a comment period will follow the proposed rule, with a deadline expected to fall on Dec. 19. The agency will then respond to all comments before the rule takes place — most likely in 2006, Sundlof suggested.

Comprehensive information about FDA’s work on BSE and links to other related Web sites are available at www.fda.gov/oc/opacom/hottopics/bse.html.


— Information provided by FDA; compiled by Crystal Albers, Angus Production Inc.

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