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U.S. Department of Health and Human Services

Animal & Veterinary

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Consent Decree of Permanent Injunction Filed Against X-Cel Feeds, Inc. Based on Violations of 1997 Animal Feed Rule

FDA Veterinarian Newsletter July/August 2003 Volume XVIII, No 4

On July 11, 2003, FDA announced the filing of a Consent Decree of Permanent Injunction against X-Cel, Feeds Inc., and individual officers based on violations of the Food, Drug, and Cosmetic Act. In the Consent Decree, the Firm and officers admitted liability for introducing adulterated and misbranded animal feeds into interstate commerce and agreed to implement measures to correct the violations under FDA’s supervision.
X-Cel, a feed manufacturer headquartered in Tacoma, Washington, failed to comply with FDA regulations (the 1997 Animal Feed Rule) designed to prevent the establishment and spread of Bovine Spongiform Encephalopathy (BSE, also known as “Mad Cow Disease”) should it ever be found in the United States and FDA regulations concerning the manufacture of medicated feeds.

“No case of BSE has ever been documented in the U.S., despite aggressive surveillance, said FDA Commissioner Mark B. McClellan, M.D., Ph.D. “FDA’s animal feed regulations provide a firewall against BSE, and we are committed to strictly enforcing the rules that protect Americans from this disease.”

The Department of Justice, Civil Division, Office of Consumer Litigation and the United States Attorney’s Office of the Western District of Washington filed the Consent Decree in the United States District Court of the Western District in Tacoma, Washington. It permanently enjoins X-Cel from manufacturing animal feeds in violation of the Food, Drug, and Cosmetic Act and requires the firm, its officers, and employees to take specific steps to avoid future violations including, implementing clean-out procedures, obtaining protein supplier certifications and implementing standard operating procedures for compliance until it satisfies FDA that it has corrected its problems.

FDA’s animal feed regulations protect the United States from the potential threat of BSE by prohibiting the use of certain proteins derived from mammalian tissue in the feed for cattle and other ruminant animals.

In addition, FDA and the State regulatory agencies have increased the number of inspections of renderers, animal feed manufacturers, and other firms responsible for keeping prohibited mammalian protein out of cattle and other ruminant feed. U.S. industry compliance with the 1997 Animal Feed Rule currently exceeds 99 percent.
In order to prevent the establishment and spread of BSE in the United States the Animal Feed Rule requires animal feed manufacturers to: (1) take measures (including cleaning) to prevent contamination of ruminant feeds with mammalian proteins prohibited in ruminant feeds; (2) maintain sufficient records to track the mammalian proteins prohibited in ruminant feeds through their receipt, processing, and distribution; and (3) label animal feeds that contain mammalian proteins prohibited in ruminant feed with the required cautionary statement “Do not feed to cattle or other ruminants.”