CVM Update

The Food and Drug Administration (FDA) announced the availability of a revised guidance for industry entitled "Dioxin in Anti-Caking Agents Used in Animal Feed and Feed Ingredients'' (#98) in the April 19, 2000, Federal Register. This guidance is intended to notify members of the feed industry of recent findings regarding the presence of dioxin congeners that may be present in anti-caking agents and to offer general advice regarding the monitoring of these products. This document has been revised in response to comments on the guidance issued on October 6, 1999. FDA has revised the guidance document by replacing the term "mined clay products" with "clay and non-clay anti-caking products." These changes were made to more accurately reflect the scope of the affected products (clay and non-clay) and to emphasize that our primary concern is for the use of these products (anti-caking) in feed and feed ingredients and not when used as litter or absorbents.

Approximately two years ago, a multi-agency investigation tracked a previously unknown source of dioxins to a clay anti-caking agent, called ball clay, used as an ingredient in animal feeds. Together, industry and government moved swiftly to eliminate the use of ball clay in the animal feeds and thereby remove a source of dioxins in human food.

In an October 7, 1997, letter to members of the feed industry, we stated that the origin and scope of dioxins in clay deposits were unknown and, for this reason, mined clay products of all types should be used with caution in the production of animal feeds. We advised companies offering anti-caking products for animal feed uses to assure that their products were not contaminated with dioxins.

Many industry participants tested clay products used in animal feeds in 1998. Also, in late 1998, FDA collected samples of clay and non-clay anti-caking products from feed and oilseed sites where they were being used. The Environmental Protection Agency (EPA) subjected the samples to the complete analysis for all 17 dioxin and furan congeners of toxicological importance. FDA shared our findings and our future plans with industry.

FDA and EPA are continuing to investigate the sources of the more elevated samples; however, the information thus far indicates the need for continued attention by the industry in the surveillance of clay and non-clay anti-caking feed ingredients.

Copies of this guidance document may be obtained on the Internet from the CVM 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.

Comments and suggestions regarding this guidance document should be submitted to the Dockets Management Branch (HFV-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should be identified with the Docket Number (99D-4201).

Further information about the guidance document is included in the April 19, 2000, Federal Register announcement. General questions regarding this guidance document may be directed to Judy Gushee, Center for Veterinary Medicine (HFV-232), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-0150, e-mail: jgushee@cvm.fda.gov. Scientific questions regarding this guidance document may be directed to Dr. Randall Lovell, Center for Veterinary Medicine (HFV-222), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-0176, e-mail: rlovell@cvm.fda.gov.