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March 12, 2003

FDA Information for Manufacturers of Animal Feed Mineral Mixes

FDA is alerting firms manufacturing mineral mixes and mineral premixes for use in animal feed that minerals that are by-products or co-products of industrial metal production may contain dioxin. Recently, FDA found that some of these by-products or co-products contained high levels of dioxin, and requested that the specific products be recalled. In March 2002, FDA requested a recall of protected minerals and mineral premixes because of high levels of dioxin. In the 2002 case, the source of the dioxins was related to the high temperature process used in making the protected minerals. The Agency believes that in the current case the process used to produce brass resulted in the dioxin contamination of zinc oxide. FDA will be actively checking these and similar products for dioxin.

Dioxins are ubiquitous, low level environmental contaminants. With cumulative exposure, they are potential carcinogens and may cause reproductive or developmental health problems. Environmental sources of dioxin pollution have been markedly reduced over the past decade. The result has been a significant reduction in overall dioxin exposure to the public. Presently, the primary source of human exposure to dioxins is through food.

Earlier this year, FDA’s food and feed surveillance programs detected elevated levels of dioxin in a feed and traced the dioxin to a mineral component of that feed. The implicated zinc oxide and zinc oxide premixes that were used in livestock, aquaculture, and poultry feed contained extremely high levels of dioxin. A recall of these products and feed containing the zinc oxide has been implemented. An additional mineral component (copper oxide) is also being investigated as a possible source of dioxin. Both mineral components currently under investigation are reclamation products from industrial metal production.

FDA's public health objective is to reduce the level of exposure to dioxin in the animal and human foods by finding and stopping sources of added dioxin from entering the food supply. To further reduce public exposure to dioxins, FDA will continue its food and feed surveillance programs, and continue investigating whether other products from industrial metal production that are used as feed ingredients are a source of dioxin.

Firms or individuals that have questions about this subject may contact Ms.Gloria Dunnavan, Division of Compliance, Center for Veterinary Medicine at 301-827-1168.


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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