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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA GUIDANCE ON BSE FEED REGULATION AVAILABLE

FDA Veterinarian Newsletter September/October 1998 Volume XIII, No V

FDA’s Center for Veterinary Medicine (CVM) has released a guide intended to answer questions about "Animal Proteins Prohibited from Animal Feed", the BSE feed regulation. The guide, titled "Questions and Answers -- BSE Feed Regulation" (Guidance Document 76) is intended to supplement the Small Entity Compliance Guides for the regulation, specifically the following FDA Guidance for Industry documents:

67 - Renderers
68 - Protein Blenders, Feed Manufacturers, and Distributors
69 - Feeders of Ruminant Animals With On-Farm Feed Mixing Operations
70 - Feeders of Ruminant Animals Without On-Farm Feed Mixing Operations

FDA’s final rule (21 CFR 589.2000) became effective August 4, 1997, and prohibits the feeding of certain mammalian protein to ruminant animals. It is designed to prevent the establishment and amplification through feed of bovine spongiform encephalopathy (BSE) in the United States.

Recently, CVM cosponsored a national satellite teleconference to show feed mill managers how to comply with the BSE rule, and to help assure them that an FDA inspection would find their mill in compliance. Questions and answers from the teleconference will be available soon, and posted on CVM’s Internet Home Page, completely separate from this guidance document.

The guide is available through the CVM Internet Home Page or by contacting the FDA Veterinarian. Additional information regarding this document may be obtained by contacting Gloria Dunnavan, Center for Veterinary Medicine, Division of Compliance, HFV-230, 7500 Standish Place, Rockville, MD 20855, 301-594-1726.