04-3558. zuChem, Inc.; Filing of Food Additive Petition

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that zuChem, Inc. has filed a petition proposing that the food additive regulations be amended to permit the manufacture of mannitol by fermentation of sugars such as fructose, glucose, or maltose by the action of the microorganism Lactobacillus intermedius (fermentum).

FOR FURTHER INFORMATION CONTACT:

Celeste Johnston, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 202-418-3423.

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 4A4754) has been filed by zuChem Inc., c/o Hyman, Phelps and McNamara, P.C., 700 Thirteenth St. NW., Washington, DC 20005. The petition proposes to amend the food additive regulations in § 180.25 Mannitol (21 CFR 180.25) to permit the manufacture of mannitol by fermentation of sugars such as fructose, glucose, or maltose by the action of the microorganism Lactobacillus intermedius (fermentum).

The agency has determined under 21 CFR 25.32(r) 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: February 9, 2004.

George H. Pauli,

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