95-8773. Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers  

  • [Federal Register Volume 60, Number 69 (Tuesday, April 11, 1995)]
    [Rules and Regulations]
    [Pages 18352-18353]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 95-8773]
    
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    21 CFR Part 178
    
    [Docket No. 91F-0499]
    
    
    Indirect Food Additives: Adjuvants, Production Aids, and 
    Sanitizers
    
    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 2,4-di-tert-pentyl-
    6-[1-(3,5-di-tert-pentyl-2-hydroxyphenyl)ethyl]phenyl acrylate as an 
    antioxidant in the manufacture of polystyrene and rubber-modified 
    polystyrene articles that contact food. This action is in response to a 
    petition filed by Sumitomo Chemical America, Inc.
    
    DATES: Effective April 11, 1995; written objections and requests for a 
    hearing by May 11, 1995.
    
    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:  Daniel N. Harrison, Center for Food 
    Safety and Applied Nutrition (HFS-216), Food and Drug Administration, 
    200 C St. SW., Washington, DC 20204, 202-254-9500.
    
    SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
    Register of January 30, 1992 (57 FR 3633), FDA announced that a food 
    additive petition (FAP 2B4295) had been filed by Sumitomo Chemical 
    America, Inc., 345 Park Ave., New York, NY 10154. The petition proposed 
    to amend the food additive regulations in Sec. 178.2010 Antioxidants 
    and/or stabilizers for polymers (21 CFR 178.2010) to provide for the 
    safe use of 2,4-di-tert-pentyl-6-[1-(3,5-di-tert-pentyl-2-
    hydroxyphenyl)ethyl]phenyl acrylate as an antioxidant in the 
    manufacture of polystyrene and rubber-modified polystyrene articles 
    that contact food.
        FDA has evaluated data in the petition and other relevant material. 
    The agency concludes that the proposed food additive use is safe, and 
    that the regulations in Sec. 178.2010(b) 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 May 11, 1995, 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 
    [[Page 18353]] 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: Secs. 201, 402, 409, 721 of the Federal Food, Drug, 
    and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).
    
         2. Section 178.2010 is amended in the table in paragraph (b) for 
    the entry ``2,4-di-tert-pentyl-6-[1-(3,5-di-tert-pentyl-2-
    hydroxyphenyl)ethyl]phenyl acrylate'' by adding a new entry ``3.'' 
    under the heading ``Limitations'' to read as follows:
    
    
    Sec. 178.2010  Antioxidants and/or stabilizers for polymers.
    
    * * * * *
        (b) * * *
    
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                 Substances                          Limitations            
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                          *      *      *      *      *                     
    2,4-Di-tert-pentyl-6-[1-(3,5-di-     For use only:                      
     tert-pentyl-2-                                                         
     hydroxyphenyl)ethyl]phenyl                                             
     acrylate (CAS Reg. No.123968-25-                                       
     2)..                                                                   
                                         * * *                              
                                          3. At levels not to exceed 0.5    
                                          percent by weight of polystyrene  
                                          and rubber-modified polystyrene   
                                          complying with Sec. 177.1640 of   
                                          this chapter in contact with all  
                                          food types under conditions of use
                                          D through G as described in Table 
                                          2 of Sec. 176.170(c) of this      
                                          chapter.                          
                          *      *      *      *      *                     
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        Dated: April 3, 1995.
    L. Robert Lake,
    Director, Office of Policy, Planning and Strategic Initiatives, Center 
    for Food Safety and Applied Nutrition.
    [FR Doc. 95-8773 Filed 4-10-95; 8:45 am]
    BILLING CODE 4160-01-F
    
    

Document Information

Effective Date:
4/11/1995
Published:
04/11/1995
Department:
Health and Human Services Department
Entry Type:
Rule
Action:
Final rule.
Document Number:
95-8773
Dates:
Effective April 11, 1995; written objections and requests for a hearing by May 11, 1995.
Pages:
18352-18353 (2 pages)
Docket Numbers:
Docket No. 91F-0499
PDF File:
95-8773.pdf
CFR: (1)
21 CFR 178.2010