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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Issues Draft Guidance for Renderers on Substances Prohibited From Use in Animal Food or Feed

November 25, 2008

The Food and Drug Administration (FDA) today issued a draft guidance document for renderers in response to questions received since the April 25, 2008 announcement of a final rule that strengthens regulations regarding animal feed. This strengthened rule will help to further protect consumers against bovine spongiform encephalopathy (BSE), otherwise known as ‘mad cow disease.’

The purpose of the guidance document is to help rendering firms comply with the rule that becomes effective April 27, 2009. The guidance should also help slaughter facilities and farms supplying offal and dead livestock to the renderers understand their obligations under the rule. A copy of the draft guidance can be found at: http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0597-gdl.pdf.

The added measure of excluding high-risk materials from all animal feeds addresses risks associated with accidental feeding of such material to cattle, which could occur through cross-contamination of ruminant feed, with non-ruminant feed or feed ingredients during manufacture and transport, or through misfeeding of non-ruminant feed to ruminants on the farm.

Interested persons may submit written comments about the guidance document on or before January 26, 2009 to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Electronic comments may be submitted to: http://www.fda.gov/ohrms/dockets/FDMS/SubmissionInformation.htm. Identify all submissions to the docket with the following docket number: 2008-D-0597.

For additional information on BSE and the final rule, please see: http://www.fda.gov/cvm/bsetoc.html.

For questions regarding this draft document, please contact Shannon Jordre at FDA’s Center for Veterinary Medicine, 240-276-9229, shannon.jordre@fda.hhs.gov.


Contact FDA

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

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855