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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Approves Food Additive Petition For Formaldehyde

April 9, 1996

FDA announced that the Agency is amending the food additive regulations to provide for the safe use of formaldehyde (37 percent aqueous solution), at the rate of 5.4 pounds per ton (2.5 kilograms per ton) as an antimicrobial food additive for maintaining complete poultry feeds salmonella negative for up to 14 days. This action is in response to a food additive petition filed by Anitox Corp, Buford, Georgia.

Salmonella is known to cause animal disease. The effect of subclinical cases of salmonella on animal production is difficult to quantitate. However, there are circumstantial data suggesting a potential link between the organisms in feed and organisms causing human and animal salmonellosis. For this reason in 1990, FDA announced a salmonella negative goal for animal feed and feed ingredients.

The availability of compounds that can control re-contamination of a feed with salmonella is important to achieving the goal of salmonella negative for animal feed and feed ingredients. In the September 28, 1995 Federal Register, FDA defined salmonella negative as 10 samples, from a production lot, testing negative for salmonella using the culture procedure described in the 7th Edition of FDA's Bacteriological Analytical Manual.

FDA has evaluated the data in the food additive petition for formaldehyde and other relevant material. The Agency concluded that formaldehyde (37 percent aqueous solution) is safe when used at the rate of 5.4 pounds (2.5 kilograms) per ton of poultry feed, and that the regulations should be amended in Title 21, Part 573.460.

Additional information on this food additive approval is available in the Federal Register announcement or by contacting Dr. Daniel G. McChesney, Center for Veterinary Medicine (HFV-222), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-594-1728. Any person who will be adversely affected by this regulation may file written objections on or before May 9, 1996, with the Dockets Management Branch (HFA-305), Food and Drug Administration, Room 1-23, 12420 Parklawn Drive, Rockville, MD 20857.


Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855