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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

July 14, 1998

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:

  1. 67 - Renderers
  2. 68 - Protein Blenders, Feed Manufacturers, and Distributors
  3. 69 - Feeders of Ruminant Animals With On-Farm Feed Mixing Operations
  4. 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 calling the CVM Communications Staff at 301-594-1755. 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.


Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855