October 20, 1995
FOOD ADDITIVE PETITION FOR RADIATION OF POULTRY FEED
In the September 28, 1995 Federal Register, the FDA announced that the Agency is amending the food additive regulations to provide for the safe use of gamma radiation from cobalt-60 in an absorbed dose range of 2 kiloGrays (kGy) (0.2 Megarads) (Mrad) to 25 kGy (2.5 Mrad), in poultry feed products. This action is in response to a food additive petition filed by Nordion International, Inc., Kanata, Ontario, Canada.
The use of irradiation was evaluated based on its ability to render poultry feeds and poultry feed ingredients salmonella negative. Salmonella is known to cause animal disease. The effect of subclinical cases of salmonella on animal production is difficult to quantitate. There are, however, substantial 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 goal of salmonella negative for animal feed and feed ingredients. FDA has defined salmonella negative as 10 samples from a continuous production lot testing negative for salmonella using the culture procedure described in the 7th edition of FDA's Bacteriological Analytical Manual.
Data submitted by the sponsor indicate that an irradiation dose of 1.0 kGy effectively reduces the salmonella count by 1 log cycle (one decimal reduction). To ensure that irradiation achieves the intended purpose, all portions of the feed must receive at least the minimum absorbed dose. The minimum absorbed dose should be based on initial salmonella concentration using the relationship that 1 kGy reduces salmonella concentration by 1 log cycle. Based on the statistical power of the sampling plan, the minimum dose should be no less than 2 kGy in order to ensure that the salmonella negative definition is met.
Data submitted by the sponsor indicate that irradiation does have a minimal effect on the content of some nutrients such as water soluble vitamins and some amino acids. Feeds treated by irradiation should be formulated to account for such nutritional loss.
FDA has evaluated the data in the petition and other relevant material. The Agency concluded that irradiation of poultry feeds and poultry feed ingredients is safe when the feed is formulated to allow for nutritional loss, and that the regulations should be amended by adding new section (Title 21, Part 579.40.)
This amendment will allow the marketing of irradiation equipment by manufacturers, such as Nordion, for use by the poultry feed industry. Irradiation of poultry feed products is to be performed in a facility licensed by the U.S. Nuclear Regulatory Commission. Irradiators are to be operated in conformance to the requirements of the U.S. Department of Energy (10 CFR 51). The sponsor has indicated that there are currently at least twenty contract irradiation facilities in the U.S. capable of irradiating poultry feed products.
Additional information on this food additive approval is available in the Federal Register announcement or by contacting Dr. Sharon A. Benz, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-594- 1724. Any person who will be adversely affected by this regulation may file written objections on or before October 30, 1995, with the Dockets Management Branch (HFA-305), Food and Drug Administration, Room 1-23, 12420 Parklawn Drive, Rockville, MD 20857.
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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