01-47. Troy Corp.; Filing of Food Additive Petition; Amendment

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 Troy Corp. to indicate that the petitioner has proposed that the food additive regulations be amended to provide for the safe use of butanedioic acid, sulfo-1,4-diisodecyl ester, ammonium salt as a surface active agent in adhesives, in pressure-sensitive adhesives, and in paper and paperboard intended to contact food.

FOR FURTHER INFORMATION CONTACT:

Mark A. 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:

In a notice published in the Federal Register of July 2, 1999 (64 FR 36021), FDA announced that a food additive petition (FAP 9B4678) had been filed by Troy Corp., c/o S. L. Graham & Associates, 1801 Peachtree Lane, Bowie, MD 20721. The petition proposed to amend the food additive regulations in § 175.125 Pressure-sensitive adhesives (21 CFR 175.125) to provide for the safe use of butanedioic acid, sulfo-1,4-diisodecyl ester, ammonium salt as a surface active agent in pressure sensitive adhesives.

Subsequent to the publication of the filing notice, the petition was amended to include a proposal to further amend the food additive regulations in 21 CFR 175.105 Adhesives, 21 CFR 176.170 Components of paper and paperboard in contact with aqueous and fatty food, 21 CFR 176.180 Components of paper and paperboard in contact with dry foods, and 21 CFR 178.3400 Emulsifiers and/or surface active agents to provide for the safe use of butanedioic acid, sulfo-1,4-diisodecyl ester, ammonium salt as a surface active agent in adhesives, and in paper and paperboard intended to contact food.

Therefore, FDA is amending the filing notice of July 2, 1999, to indicate that the petitioner requests that the food additive regulations be amended to provide for the safe use of butanedioic acid, sulfo-1,4-diisodecyl ester, ammonium salt as a surface active agent in adhesives, in pressure sensitive adhesives, and in paper and paperboard intended to contact food.

The agency had previously determined under 21 CFR 25.32(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: November 22, 2000.

Alan M. Rulis,

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