[Federal Register Volume 61, Number 227 (Friday, November 22, 1996)] [Rules and Regulations] [Pages 59330-59331] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-29874] [[Page 59330]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 177 [Docket No. 95F-0365] Indirect Food Additives: Polymers AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of ethylene/pentene-1 copolymers containing not less than 90 percent of polymer units derived from ethylene as components of articles intended for use in contact with food. This action is in response to a petition filed by Sasol Alpha Olefins. DATES: Effective November 22, 1996; written objections and requests for a hearing by December 23, 1996. ADDRESSES: Submit written objections to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Daniel N. Harrison, Center for Food Safety and Applied Nutrition (HFS-216), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3084. SUPPLEMENTARY INFORMATION: In a notice published in the Federal Register of November 15, 1995 (60 FR 57434), FDA announced that a food additive petition (FAP 5B4482) had been filed by Sasol Alpha Olefins, P.O. Box 5486, Johannesburg 2000, Republic of South Africa. The petition proposed to amend the food additive regulations in Sec. 177.1520 Olefin polymers (21 CFR 177.1520) to provide for the safe use of ethylene/pentene-1 copolymers containing not less than 90 percent of polymer units derived from ethylene as components of articles intended for use in contact with food. FDA has evaluated data in the petition and other relevant material. Based on this information, the agency concludes that the proposed food additive use is safe, that it will achieve its intended technical effect, and therefore, that the regulations in Sec. 177.1520 should be amended as set forth below. In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition are available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the information contact person listed above. As provided in Sec. 171.1(h), the agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection. The agency has carefully considered the potential environmental effects of this action. FDA has concluded that the action will not have a significant impact on the human environment, and that an environmental impact statement is not required. The agency's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Dockets Management Branch (address above) between 9 a.m. and 4 p.m., Monday through Friday. Any person who will be adversely affected by this regulation may at any time on or before December 23, 1996, file with the Dockets Management Branch (address above) written objections thereto. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provisions of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. Three copies of all documents shall be submitted and shall be identified with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday. List of Subjects in 21 CFR Part 177 Food additives, Food packaging. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Director, Center for Food Safety and Applied Nutrition, 21 CFR part 177 is amended as follows: PART 177--INDIRECT FOOD ADDITIVES: POLYMERS 1. The authority citation for 21 CFR part 177 continues to read as follows: Authority: Secs. 201, 402, 409, 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e). 2. Section 177.1520 is amended by adding a new paragraph (a)(3)(i)(a)(3), and in the table in paragraph (c) by revising item 3.1a and by adding a new item 3.1c to read as follows: Sec. 177.1520 Olefin polymers. * * * * * (a) * * * (3) * * * (i) * * * (a) * * * (3) Olefin basic copolymers manufactured by the catalytic copolymerization of ethylene and pentene-1 shall contain not less than 90 weight-percent of polymer units derived from ethylene. * * * * * (c) * * * [[Page 59331]] ------------------------------------------------------------------------ Maximum extractable Maximum soluble fraction fraction Melting point (expressed as (expressed as Olefin (MP) or percent by percent by polymers Density softening point weight of weight of (SP) (Degrees polymer) in N- polymer) in Centigrade) hexane at xylene at specified specified temperatures temperatures ------------------------------------------------------------------------ * * * * * * * 3.1a Olefin 0.85-1.0 ........... 5.5 pct at 50 C 30 pct at 25 C copolymers 0 described in paragraph (a)(3)(i) of this section for use in articles that contact food except for articles used for packing or holding food during cooking; except olefin copolymers described in paragraph (a)(3)(i)( a)(3) of this section and listed in item 3.1c of this table and olefin copolymers described in paragraph (a)(3)(i)( e) of this section and listed in item 3.1b of this table. * * * * * * * 3.1c Olefin Not less ........... ........... copolymers than described 0.92 in paragraph (a)(3)(i)( a)(3) of this section for use in contact with food only under conditions of use B, C, D, E, F, G, and H described in Sec. 176.170(c) of this chapter, Table 2; except that such copolymers when used in contact with food of the types identified in Sec. 176.170(c) , Table 1, under types III, IVA, V, VIIA, and IX, shall be used only under conditions of use D, E, F, and G described in Sec. 176.170(c) of this chapter, Table 2. * * * * * * * ------------------------------------------------------------------------ * * * * * Dated: November 18, 1996. Fred R. Shank, Director, Center for Food Safety and Applied Nutrition. [FR Doc. 96-29874 Filed 11-21-96; 8:45 am] BILLING CODE 4160-01-F