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U.S. Department of Health and Human Services

Animal & Veterinary

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DRAFT FUMONISIN GUIDANCE AND BACKGROUND PAPERS AVAILABLE

FDA Veterinarian Newsletter July/August 2000 Volume XV, No IV

The Food and Drug Administration (FDA) announced the availability of a draft guidance document entitled "Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds'' in the June 6, 2000, Federal Register. The purpose of this draft guidance is to identify for the industry maximum fumonisin levels that FDA considers adequate to protect human and animal health, and that are achievable in human foods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.

Fumonisins are naturally occurring toxins produced by the molds Fusarium moniliforme (F. verticillioides), F. proliferatum, and other Fusarium species that are common contaminants of corn. Fumonisins have been linked to a variety of significant adverse health effects in livestock and experimental animals. Although human epidemiological studies are inconclusive at this time, FDA believes that an association between fumonisins and human disease is possible.

FDA considers this guidance to be a prudent public health measure during the development of a better understanding of the human health risk associated with fumonisins and the development of a long-term risk management policy and program by the Agency for the control of fumonisins. Based on information obtained from future national and international workshops on the risk from exposure to fumonisins, FDA will consider whether to establish tolerances, regulatory limits, or action levels, as appropriate, for fumonisins in human foods and animal feeds.

Copies of this draft guidance document may be obtained on the Internet from the FDA/Center for Veterinary Medicine Home Page or by writing or calling the FDA Veterinarian. Comments and suggestions regarding this guidance document should be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All written comments should be submitted by August 7, 2000 and identified with the Docket Number (00D-1277).

Further information about the guidance document may be obtained from the June 6, 2000, Federal Register announcement, or by contacting Dr. Randall A. Lovell, Center for Veterinary Medicine (HFV-222), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-0176 or from Dr. Henry Kim, Center for Food Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 200 C Street SW, Washington, DC 20204, 202-260-0631.

In addition to the draft guidance document, FDA has also released two draft background papers on fumonisins as follows: "Background Paper in Support of Fumonisin Levels in Corn and Corn Products Intended for Human Consumption (from FDA's Center for Food Safety and Applied Nutrition)" and "Background Paper in Support of Fumonisin Levels in Animal Feed" (from FDA's Center for Veterinary Medicine). Copies of these documents also are available on the FDA/CVM Home Page at the Internet address provided above or from the FDA Veterinarian.