November 15, 2001
FINAL GUIDANCE AVAILABLE ON FUMONISIN LEVELS IN HUMAN FOOD AND ANIMAL FEEDS
FDA announced the availability of a final guidance document entitled "Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds" in the November 9, 2001, Federal Register. The purpose of the guidance is to identify for the industry fumonisin levels that FDA considers adequate to protect human and animal health and that are achievable in human foods and animal feeds with the use of good agricultural and good manufacturing practices.
FDA considers this guidance to be a prudent public health measure during the development of a long-term risk management policy and program by the agency for the control of fumonisins in human foods and animal feeds. The Agency is also announcing the availability of the final supporting documents entitled "Background Paper in Support of Fumonisin Levels in Corn and Corn Products Intended for Human Consumption," and "Background Paper in Support of Fumonisin Levels in Animal Feed."
The guidance document is on the FDA Home Page. Single copies of the guidance may be obtained by writing to the Communications Staff, FDA/Center for Veterinary Medicine, 7519 Standish Place, HFV-12, Rockville, MD 20855, 301-827-3800. Please send one self-addressed adhesive label to assist in processing your request. The "Background Paper in Support of Fumonisin Levels in Corn and Corn Products Intended for Human Consumption" and "Background Paper in Support of Fumonisin Levels in Animal Feed" are available for public viewing at the FDA Dockets Management Branch (5630 Fishers Lane, Room 1061, Rockville, MD 20852) between 9 a.m. and 4 p.m. Monday through Friday. Electronic copies are available on the CVM and Fumonisins page.
Written or electronic comments concerning the final guidance and the final supporting documents may be submitted at any time 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.accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm.
Additional information may be found in the November 9, 2001, Federal Register or from Dr. Randall Lovell, Center for Veterinary Medicine (HFV-222), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-0176.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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