00-24843. Bayer Co.; Filing of Food Additive Petition; Amendment; Withdrawal in Part

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is amending the filing notice for a food additive petition filed by Bayer Co. to clarify that the petitioner's request to amend the food additive regulations to provide for a more descriptive term in place of “inhibitor of yeast,” for the safe use of dimethyl dicarbonate (DMDC) will also involve adding related limitations to 21 CFR 172.133. The agency is also announcing the withdrawal of the petitioner's additional request to amend the food additive regulations to provide for the safe use of DMDC in noncarbonated juice beverages containing up to and including 100 percent juice.

FOR FURTHER INFORMATION CONTACT:

Martha D. Peiperl, Center for Food Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3077.

SUPPLEMENTARY INFORMATION:

In a notice published in the Federal Register of March 7, 2000 (65 FR 12014), FDA announced that a food additive petition (FAP 0A4718) had been filed by Bayer Co., c/o McKenna & Cuneo LLP, 1900 K St. NW., Washington, DC 20006-1108. The petition proposed to amend the food additive regulations in § 172.133 Dimethyl dicarbonate (21 CFR 172.133) both to provide for the safe use of DMDC in noncarbonated juice beverages containing up to and including 100 percent juice and to provide for a more descriptive term in place of “inhibitor of yeast,” for the safe use of DMDC.

Upon further review of the petition, FDA determined that, if granted, the requested amendment of § 172.133 to provide for a more descriptive term in place of “inhibitor of yeast” for the safe use of DMDC will also require adding related limitations to this regulation. Therefore, FDA is amending the filing notice of March 7, 2000, to indicate that this proposed amendment will involve adding related limitations to § 172.133.

The petitioner's additional request, to amend the food additive regulations to provide for the safe use of DMDC in noncarbonated juice beverages containing up to and including 100 percent juice, was converted to a food contact substance notice (FCN 0035), 21 U.S.C. 348(h)(5). This request to amend the food additive regulations was withdrawn from the petition as of the effective date of FCN 0035 (June 9, 2000).

The agency has determined under 21 CFR 25.30(I) 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: September 14, 2000.

Alan M. Rulis,

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