[Federal Register: August 28, 1998 (Volume 63, Number 167)] [Notices] [Page 46053] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr28au98-108] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 97F-0213] Asahi Denka Kogyo K.K.; 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 Asahi Denka Kogyo K.K. to indicate that the petitioned additive, phosphorous acid, cyclic neopentanetetrayl bis(2,6-di-tert-butyl-4-methylphenyl)ester is for use as an antioxidant and/or stabilizer in polypropylene homopolymer and copolymers not to exceed 0.25 percent by weight of polypropylene homopolymer and copolymers in contact with food. The previous filing notice indicated that the proposed additive was for use in olefin copolymers and polypropylene in contact with certain food categories. DATES: Written comments on the petitioner's environmental assessment by September 28, 1998. ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane., rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Hortense S. Macon, Center for Food Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3086. SUPPLEMENTARY INFORMATION: In a notice published in the Federal Register of June 9, 1997 (62 FR 31433), FDA announced that a food additive petition (FAP 7B4542) had been filed by Asahi Denka Kogyo K.K., Shirahata 5-Chome, Urawa City, Saitama 366, Japan, proposing that Sec. 178.2010 Antioxidants and/or stabilizers for polymers (21 CFR 178.2010) be amended to provide for the expanded safe use of phosphorous acid, cyclic neopentanetetrayl bis(2,6-di-tert-butyl-4- methylphenyl)ester for use: (1) At levels not to exceed 0.25 percent by weight of olefin copolymers complying with Sec. 177.1520 (21 CFR 177.1520) in contact with foods of types I, II, III, IV-B, VI-B, and VIII, as described in Table 1, and under conditions of use B through H, described in Table 2 of Sec. 176.170(c) (21 CFR 176.170(c)), of this chapter, and with food types IV-A, V, VI-A, VI-C, VII-A, and IX, under conditions of use C through G, as described in Sec. 176.170(c), Tables 1 and 2, respectively; and (2) at levels not to exceed 0.10 percent by weight of either olefin copolymers or polypropylene complying with Sec. 177.1520, which may be used only in contact with foods of types IV-A, V, VI-C, VII-A, and IX, under conditions of use H, as described in Sec. 176.170(c) of this chapter, Tables 1 and 2, respectively. Upon further review of the petition, the agency noted that the data presented in the petition address use of the subject additive only in polypropylene homopolymer and polypropylene copolymers. The agency also noted that the data in the petition in combination with the data for those applications of the additive currently listed in Sec. 178.2010, apply to the use of the subject additive in polypropylene homopolymer and copolymers in contact with all food types under conditions of use B through H as described in Table 2 of Sec. 176.170(c). Based on this information, the petitioner agreed to amend its request. Therefore, FDA is amending the filing notice of June 9, 1997, to state that the petitioner requests that the food additive regulations be amended to permit use of the subject additive in polypropylene homopolymer and copolymers for all food types under conditions of use B through H. The potential environmental impact of this action is being reviewed. To encourage public participation consistent with regulations promulgated under the National Environmental Policy Act (40 CFR 1501.4(b)), the agency is placing the environmental assessment submitted with the petition that is the subject of this notice on display at the Dockets Management Branch (address above) for public review and comment. Interested persons may, on or before September 28, 1998, submit to the Dockets Management Branch (address above) written comments. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday. FDA will also place on public display any amendments to, or comments on, the petitioner's environmental assessment without further announcement in the Federal Register. If, based on its review, the agency finds that an environmental impact statement is not required and this petition results in a regulation, the notice of availability of the agency's finding of no significant impact and the evidence supporting that finding will be published with the regulation in the Federal Register in accordance with 21 CFR 25.40(c). Dated: August 6, 1998. Laura M. Tarantino, Acting Director, Office of Premarket Approval, Center for Food Safety and Applied Nutrition. [FR Doc. 98-23103 Filed 8-27-98; 8:45 am] BILLING CODE 4160-01-F