03-11496. Food Steris Corp.; Filing of Food Additive Petition

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that Steris Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of ionizing radiation for the control of microbial contamination on dietary supplements up to a maximum absorbed dose of 30 kiloGray (kGy).

FOR FURTHER INFORMATION CONTACT:

Lane A. Highbarger, Center for Food Safety and Applied Nutrition (HFS-255), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 202-418-3032.

SUPPLEMENTARY INFORMATION:

Under the Federal Food, Drug, and Cosmetic Act (sec. 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food additive petition (FAP 2M4741) has been filed by Steris Corp., P.O. Box 147, St. Louis, MO 63166. The petition proposes that the food additive regulations in part 179 Irradiation in the Production, Processing and Handling of Food (21 CFR part 179) be amended to provide for the safe use of ionizing radiation for the control of microbial contamination on dietary supplements, and ingredients used in the manufacture of dietary supplements, up to a maximum absorbed dose of 30 kGy.

The agency has determined under 21 CFR 25.32(j) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

Dated: April 16, 2003.

Alan M. Rulis,

Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition.