01-1868. Avecia, Inc.; Filing of Food Additive Petition

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that Avecia, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of Poly(hexamethylenebiguanide) hydrochloride as a preservative for food-contact paper coating formulations.

FOR FURTHER INFORMATION CONTACT:

Mark Hepp, Center for Food Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3098.

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 1B4726) has been filed by Avecia, Inc., 1405 Foulk Rd., P.O. Box 15457, Wilmington, DE 19850-5457. The petition proposes to amend the food additive regulations in § 176.170 Components of paper and paperboard in contact with aqueous and fatty foods (21 CFR 176.170) and § 176.180 Components of paper and paperboard in contact with dry food (21 CFR 176.180) to provide for the safe use of Poly(hexamethylenebiguanide) hydrochloride as a preservative for food-contact paper coating compositions.

The agency has determined under 21 CFR 25.32(q) 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: January 4, 2001.

Alan M. Rulis,

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