October 19, 1999
GUIDANCE AVAILABLE ON DIOXIN IN ANIMAL FEED
The Food and Drug Administration (FDA) announced the availability of a guidance for industry entitled "Dioxin in Anti-Caking Agents Used in Animal Feed and Feed Ingredients'' (#98) in the October 15, 1999, Federal Register. The guidance is intended to notify members of the feed industry of recent findings regarding the presence of dioxins in mined clays that may be used as anti-caking agents in animal feeds and to offer general advice regarding monitoring of these clays.
Approximately two years ago, a multi-agency investigation tracked a previously unknown source of dioxins in the human food supply back to a mined clay anti-caking agent, called ball clay, used in animal feeds and feed ingredients. Together, industry and government moved to swiftly eliminate the use of ball clay in the animal feeds, and thereby, removed a source of dioxins in the human food chain. On October 7, 1997, FDA sent a letter regarding this issue to members of the feed industry. In that letter, we stated that the ultimate origin and the scope of dioxin presence in clay deposits were unknown and, for that reason, mined clay products of all types should be used with caution in the production of animal feeds. We advised companies offering mined clay products for animal feed uses to ensure that their products were not contaminated with dioxins.
Since that time, FDA has been collecting additional data. The information thus far indicates that dioxins can be present in mined clay products other than ball clay and that dioxin congeners other than 2,3,7,8-tetrachlorodibenzodioxin may be present in important amounts. The guidance summarizes the data and suggests the need for increased caution in industry surveillance for dioxins in feed ingredients.
Copies of this guidance document may be obtained on the Internet from our Home Page or by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, 301-594-1755.
Written comments on the guidance document 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. The full title of the guidance document and Docket No. 99D-4201 should be included on the comments.
Further information about the guidance document is included in the October 15, 1999, Federal Register announcement. General questions regarding the guidance document may be directed to Judy A. Gushee, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7500 Standish Place Rockville, MD 20855, 301-827-0150. Scientific questions regarding the guidance document may be directed to Dr. Randall A. 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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