97-14602. Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers  

  • [Federal Register Volume 62, Number 107 (Wednesday, June 4, 1997)]
    [Rules and Regulations]
    [Pages 30455-30456]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-14602]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    
    21 CFR Part 178
    
    [Docket No. 96F-0369]
    
    
    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 expanded safe use of 
    triisopropanolamine as a component of phosphorous acid, cyclic 
    butylethyl propanediol, 2,4,6-tri-tert-butylphenyl ester, as a 
    stabilizer for olefin polymers intended for use in contact with food. 
    This action is in response to a petition filed by General Electric Co.
    
    DATES: Effective June 4, 1997; written objections and requests for a 
    hearing by July 7, 1997.
    
    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: Vir D. Anand, Center for Food Safety 
    and Applied Nutrition (HFS-215), 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 October 11, 1996 (61 FR 53379), FDA announced that a food 
    additive petition (FAP 6B4522) had been filed by General Electric Co., 
    One Lexan Lane, Mt. Vernon, IN 47620-9364. 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 
    expanded safe use of triisopropanolamine as a component of phosphorous 
    acid, cyclic butylethyl propanediol, 2,4,6-tri-tert-butylphenyl ester, 
    as a stabilizer for olefin polymers intended for use in contact with 
    food.
        FDA has evaluated data in the petition and other relevant material. 
    The agency concludes that: (1) The proposed use of the additive is 
    safe, (2) the additive will achieve its intended technical effect, and 
    (3) the regulations in Sec. 178.2010 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 July 7, 1997, 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 objection 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: 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) by 
    revising the entry for ``Phosphorous acid, cyclic butylethyl 
    propanediol, 2,4,6-tri-tert-butylphenyl ester'' under the headings 
    ``Substances'' and ``Limitations'' to read as follows:
    
    
    Sec. 178.2010  Antioxidants and/or stabilizers for polymers.
    
    * * * * *
        (b) * * *
    
    [[Page 30456]]
    
    
    
                                                                                                                    
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                           Substances                                              Limitations                      
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    Phosphorous acid, cyclic butylethyl propanediol, 2,4,6-  For use only:                                          
     tri-tert-butylphenyl ester (CAS Reg. No. 161717-32-4),  1. At levels not to exceed 0.2 percent by weight of    
     which may contain not more than 1 percent by weight of   olefin polymers complying with Sec.  177.1520(c) of   
     triisopropanolamine (CAS Reg. No. 122-20-3).             this chapter, items 1.1, 1.2, or 1.3, and items 2.1,  
                                                              2.2, or 2.3 (where the density of these polymers is   
                                                              not less than 0.94 gram per cubic centimeter), and    
                                                              items 3.1 or 3.2, provided that the finished polymer  
                                                              contacts foods of types I, II, and VI-B as described  
                                                              in Table I of Sec.  176.170(c) of this chapter only   
                                                              under conditions of use B, C, D, E, F, G, and H as    
                                                              described in Table 2 of Sec.  176.170(c) of this      
                                                              chapter.                                              
                                                             2. At levels not to exceed 0.1 percent by weight of    
                                                              olefin polymers complying with Sec.  177.1520(c) of   
                                                              this chapter, items 1.1, 1.2, or 1.3, that contact    
                                                              food of types III, IV, V, VI-A, VI-C, VII, VIII, and  
                                                              IX as described in Table 1 of Sec.  176.170(c) of this
                                                              chapter, only under conditions of use C, D, E, F, and 
                                                              G as described in Table 2 of Sec.  176.170(c) of this 
                                                              chapter.                                              
      *                    *                    *                    *                    *                    *    
                                                                 *                                                  
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        Dated: May 15, 1997.
    Fred R. Shank,
    Director, Center for Food Safety and Applied Nutrition.
    [FR Doc. 97-14602 Filed 6-3-97; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Effective Date:
6/4/1997
Published:
06/04/1997
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule.
Document Number:
97-14602
Dates:
Effective June 4, 1997; written objections and requests for a hearing by July 7, 1997.
Pages:
30455-30456 (2 pages)
Docket Numbers:
Docket No. 96F-0369
PDF File:
97-14602.pdf
CFR: (1)
21 CFR 178.2010