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FDA Draft Compliance Guide on New Feed Rules Now Available

Tuesday, November 25, 2008

(American Meat Institute)

The Food and Drug Administration’s (FDA) draft compliance guide for industry on the agency’s regulations to prohibit the use of certain cattle materials in animal feed is now available.  The document will publish Nov.26 in the Federal Register, and will be available for comment during the next 60 days.

On April 25, 2008, FDA published a final rule establishing a new regulation prohibiting  the following materials in animal feed: the entire carcass of bovine spongiform encephalopathy (BSE)-positive cattle; the brains and spinal cords from cattle 30 months of age and older; the entire carcass of cattle not inspected and passed for human consumption that are 30 months of age or older from which brains and spinal cords were not removed; tallow that is derived  from BSE-positive cattle; tallow that is derived from other materials prohibited by this rule that contains more than 0.15 percent insoluble  impurities; and mechanically separated beef that is derived from the  materials prohibited by this rule.

The final rule is scheduled to go into effect April 27, 2009.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

To view this draft guidance, click here: http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0597-gdl.pdf.

Submit written comments on this guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments may also be submitted electronically on the Internet at http://www.regulations.gov.

All written comments should be identified with Docket No. FDA2008-D-0597.

For questions regarding this draft guidance document, contact Shannon Jordre, Division of Compliance (HFV-230), U.S. Food and Drug Administration, Center for Veterinary Medicine, 7519 Standish Place, MPN-4, Rockville, MD 20855, (240) 276-9229.


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