Food additives: Adhesives coatings and components— propanediamine, etc.,

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Federal Register: May 14, 1999 (Volume 64, Number 93)Rules and RegulationsPage 26281-26282From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr14my99-4

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

Docket No. 91F-0399Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers

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 1,3-propanediamine, N,N''-1,2-ethanediylbis-, polymer with N-butyl-2,2,6,6-tetramethyl-4- piperidinamine and 2,4,6-trichloro-1,3,5-triazine as a light stabilizer for polypropylene and polyethylene complying with 21 CFR 177.1520. This action responds to a petition filedby 3-V Chemical Corp.

DATES: The regulation is effective May 14, 1999. Submit written objections and requests for a hearing by June 14, 1999. ADDRESSES: Submit written objections to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Julius Smith, Center for Food Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3091.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal Register of January 3, 1992 (57 FR 291), FDA announced that a petition (FAP 1B4277) had been filedby 3-V Chemical Corp., P.O. Box Drawer Y, Georgetown, SC 29442, proposing to amend Sec. 178.2010 Antioxidants and/or stabilizers for polymers (21 CFR 178.2010), to provide for the safe use of 1,3-propanediamine, N,N''-1,2-ethanediylbis-, polymer with N-butyl-2,2,6,6-tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5- triazine as a light stabilizer for polyethylene and polypropylene complying with 21 CFR 177.1520. FDA has evaluated the data in the petition and other relevant material. Based on this information, the agency concludes that the proposed use of the additive is safe, that the additive will have the intended technical effect, and therefore, that the regulations 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. This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

[Page 26282]Any person who will be adversely affected by this regulation may at any time on or before June 14, 1999, 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 178

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 178 is amended as follows:

PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS

1. The authority citation for 21 CFR part 178 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348, 379e.

2. Section 178.2010 is amended in the table in paragraph (b) by alphabetically adding an entry under the headings ``Substances'' and ``Limitations'' to read as follows:

Sec. 178.2010 Antioxidants and/or stabilizers for polymers.

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  (b) * * *

Substances

Limitations

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* * 1,3-Propanediamine, N,N''-1,2-ethanediylbis-, polymer For use only: with N-butyl-2,2,6,6-tetramethyl-4-piperidinamine and 1. At levels not to exceed 0.3 percent by weight of 2,4,6-trichloro-1,3,5-triazine (CAS Reg. No. 136504-96- polypropylene complying with Sec. 177.1520(c) of this 6).

chapter, items 1.1, 1.2, and 1.3. 2. At levels not to exceed 0.2 percent by weight of olefin polymers having a density greater than or equal to 0.94 grams per cubic centimeter and complying with Sec. 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, and 3.2. 3. At levels not to exceed 0.3 percent by weight of olefin polymers having a density less than 0.94 grams per cubic centimeter and complying with Sec. 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, and 4.0. The finished polymers are to contact food only under conditions of use B through H described in Table 2 of Sec. 176.170(c) of this chapter, and when used in contact with fatty foods of Types III, IV-A, V, VII-A, and IX as described in Table 1 of Sec. 176.170(c) of this chapter, the finished articles are to have a volume of at least 18.9 liters (5 gallons).

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Dated: May 3, 1999. L. Robert Lake, Director, Office of Policy, Planning and Strategic Initiatives, Center for Food Safety and Applied Nutrition.

FR Doc. 99-12177Filed5-13-99; 8:45 amBILLING CODE 4160-01-F

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