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U.S. Department of Health and Human Services

Animal & Veterinary

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BSE Compliance Program Issued

FDA Veterinarian Newsletter November/December 2003 Volume XVIII, No 6

FDA has released a Compliance Program (CP) entitled "BSE/Ruminant Feed Ban Inspections." This Compliance Program is intended to assist both Agency and State investigators in determining compliance with the FDA regulation prohibiting the use of most animal proteins in ruminant feeds (21 CFR Part 589.2000 of the Code of Federal Regulations.)

Dr. Stephen F. Sundlof, Director of FDA's Center for Veterinary Medicine, said "FDA issued this CP to help provide guidance and instructions for conducting inspections under the ruminant feed rules. These inspections are extremely important in FDA's efforts to help prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE) through feed in the United States, should a case of BSE ever be found in this country."

The success of the inspection program depends on a multitude of State investigators in addition to FDA investigators. In fact, the majority of the inspections have been conducted by State investigators for FDA. This Compliance Program provides comprehensive instructions for FDA and State investigators to help ensure that BSE inspections are conducted in a uniform manner and are of high quality.

The CP is posted on the CVM Home Page that can be found by clicking here. Single copies of the CP may be obtained from the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855. Please send one self-addressed adhesive label to assist in processing your request.

The CP represents the FDA's current thinking on the subject. It does not create or confer any rights for or on any person and will not operate to bind FDA or the public. Alternative methods may be used as long as they satisfy the requirements of the applicable statutes and regulations.

This CP is being issued as a Level 1 guidance consistent with FDA's good guidance practices (GGPs) regulation. It is being implemented immediately without prior public comment because of the Agency's urgent need to provide guidance in conducting inspections. However, pursuant to GGPs, FDA requests comments on the guidance and will revise the document, if appropriate. Comments will be considered by the Agency in the development of future policy.

Written comments on the CP may be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments may be submitted to: http://www.accessdata3.fda.gov/BSEInspect fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. Comments should be identified with the full title of the guidance document and Docket Number 2003D-0498.

Technical questions about the Compliance Program may be directed to Dr. Neal Bataller, Center for Veterinary Medicine, HFV-230, Food and Drug Administration, 7500 Standish Place, Rm. E441, Rockville, MD 20855, 301-827-0163, nbatalle@cvm.fda.gov.