95-29219. Indirect Food Additives: Polymers  

  • [Federal Register Volume 60, Number 231 (Friday, December 1, 1995)]
    [Rules and Regulations]
    [Page 61654]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 95-29219]
    
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    
    21 CFR Part 177
    
    [Docket No. 93F-0166]
    
    
    Indirect Food Additives: Polymers
    
    AGENCY: Food and Drug Administration, HHS.
    
    ACTION: Final rule.
    
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    SUMMARY: The Food and Drug Administration (FDA) is amending the food 
    additive regulations to provide for the safe use of pyromellitic 
    dianhydride as a modifier in the manufacture of polyethylene 
    terephthalate copolymers intended for food-contact applications. This 
    action is in response to a petition filed by M. & G. Ricerche S.p.A.
    
    DATES: Effective December 1, 1995; written objections and requests for 
    a hearing by January 2, 1996.
    
    ADDRESSES: Submit written objections to the Dockets Management Branch 
    (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
    Rockville, MD 20857.
    
    FOR FURTHER INFORMATION CONTACT: Vir D. Anand, Center for Food Safety 
    and Applied Nutrition (HFS-216), Food and Drug Administration, 200 C 
    St. SW., Washington, DC 20204, 202-418-3081.
    
    SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
    Register of August 12, 1993 (58 FR 42975), FDA announced that a food 
    additive petition (FAP 3B4375) had been filed by M. & G. Ricerche, 
    S.p.A., c/o Keller and Heckman, 1001 G St. NW., suite 500 West, 
    Washington, DC 20001 (formerly c/o Delta Analytical Corp., 7910 
    Woodmont Ave., suite 1000, Bethesda, MD 20814). The petition proposed 
    to amend the food additive regulations in Sec. 177.1630 Polyethylene 
    phthalate polymers (21 CFR 177.1630) to provide for the safe use of 
    pyromellitic dianhydride as a modifier in the manufacture of 
    polyethylene terephthalate copolymers intended for food-contact 
    applications.
        FDA has evaluated data in the petition and other relevant material. 
    The agency concludes that the proposed food additive use in 
    polyethylene terephthalate food-contact articles is safe, and the 
    regulation in Sec. 177.1630 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 21 CFR 
    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 January 2, 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 177.1630 is amended in paragraph (e)(4) by 
    alphabetically adding a new substance to paragraph (i) in the ``List of 
    Substances and Limitations'' to read as follows:
    
    
    Sec. 177.1630  Polyethylene phthalate polymers.
    
    * * * * *
        (e) * * *
        (4) * * *
    List of Substances and Limitations
        (i) * * *
    Ethylene terephthalate copolymers: Prepared by the condensation of 
    dimethyl terephthalate or terephthalic acid with ethylene glycol, 
    modified with one or more of the following: Azelaic acid, dimethyl 
    azelate, dimethyl sebacate, sebacic acid, pyromellitic dianhydride. 
    The level of pyromellitic dianhydride shall not exceed 0.5 percent 
    by weight of the finished copolymer which may be used under 
    conditions of use E through H as described in Table 2 of 
    Sec. 176.170(c) of this chapter.
    * * * * *
    
        Dated: November 21, 1995.
    Fred R. Shank,
    Director, Center for Food Safety and Applied Nutrition.
    [FR Doc. 95-29219 Filed 11-30-95; 8:45 am]
    BILLING CODE 4160-01-F
    
    

Document Information

Effective Date:
12/1/1995
Published:
12/01/1995
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule.
Document Number:
95-29219
Dates:
Effective December 1, 1995; written objections and requests for a hearing by January 2, 1996.
Pages:
61654-61654 (1 pages)
Docket Numbers:
Docket No. 93F-0166
PDF File:
95-29219.pdf
CFR: (2)
21 CFR 176.170(c)
21 CFR 177.1630