2010-7955. Nisso America, Inc.; Filing of Food Additive Petition

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that Nisso America, Inc., has filed a petition proposing that the food additive regulations for hydroxypropyl cellulose be amended by lowering the minimum viscosity from 145 centipoises (cPs) to 10 cPs and to permit its use as a binder in dietary supplements.

FOR FURTHER INFORMATION CONTACT:

Laura Dye, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1275.

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 0A4780) has been filed by Nisso America, Inc., 45 Broadway, suite 2120, New York, NY 10006. The petition proposes to amend the food additive regulations in § 172.870 Hydroxypropyl cellulose (21 CFR 172.870) by lowering the minimum permitted viscosity of hydroxypropyl cellulose identified in paragraph (a)(1) of this regulation from 145 cPs to 10 cPs and to permit its use as a binder in dietary supplements.

The agency has determined under 21 CFR 25.32(k) 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: March 17, 2010.

Mitchell A. Cheeseman,

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