97-5558. Indirect Food Additives: Paper and Paperboard Components  

  • [Federal Register Volume 62, Number 45 (Friday, March 7, 1997)]
    [Rules and Regulations]
    [Pages 10452-10453]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-5558]
    
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    
    21 CFR Part 176
    
    [Docket No. 96F-0242]
    
    
    Indirect Food Additives: Paper and Paperboard Components
    
    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 additional safe use of 
    perfluoroalkyl substituted phosphate ester acids, ammonium salts formed 
    by the reaction of 2,2-bis[(,-perfluoroC4-
    20alkylthio)methyl]-1,3-propanediol, polyphosphoric acid and ammonium 
    hydroxide, as an oil and water repellant for paper and paperboard 
    intended for use in contact with food. This action is in response to a 
    petition filed by Ciba-Geigy Corp.
    
    DATES: Effective March 7, 1997; written objections and requests for a 
    hearing by April 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-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 July 18, 1996 (61 FR 37483), FDA announced that a food 
    additive petition (FAP 6B4513) had been filed by Ciba-Geigy Corp., P.O. 
    Box 18300, Greensboro, NC 27419-8300. The petition proposed to amend 
    the food additive regulations in Sec. 176.170 Components of paper and 
    paperboard in contact with aqueous and fatty foods (21 CFR 176.170) to 
    provide for the additional safe use of perfluoroalkyl substituted 
    phosphate ester acids, ammonium salts formed by the reaction of 2,2-
    bis[(,-perfluoroC4-20alkylthio)methyl]-1,3-
    propanediol, polyphosphoric acid and ammonium hydroxide, as an oil and 
    water repellant for paper and paperboard intended for use in contact 
    with food.
        FDA has evaluated data in the petition and other relevant material. 
    The agency concludes that the proposed use of the additive in paper and 
    paperboard products in contact with non-alcoholic foods under condition 
    of use C through G as described in Table 2 of Sec. 176.170(c) is safe, 
    that the additive will have the intended technical effect, and, 
    therefore, that Sec. 176.170 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. No comments were received during the 30 day comment 
    period specified in the filing notice for comments on the environmental 
    assessment submitted with the petition.
        Any person who will be adversely affected by this regulation may at 
    any time on or before April 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 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 176
    
        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 176 is amended as follows:
    
    PART 176--INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS
    
        1. The authority citation for 21 CFR part 176 continues to read as 
    follows:
    
        Authority: Secs. 201, 402, 406, 409, 721 of the Federal Food, 
    Drug, and Cosmetic Act (21 U.S.C. 321, 342, 346, 348, 379e).
    
        2. Section 176.170 is amended in the table in paragraph (a)(5) by 
    revising the entry for ``Perfluoroalkyl substituted phosphate ester 
    acids, ammonium salts formed by the reaction of 2,2-
    bis[(,-perfluoroC4-20alkylthio)methyl]-1,3-
    propanediol, polyphosphoric acid and ammonium hydroxide'' under the 
    heading ``Limitations'' to read as follows:
    
    Sec. 176.170  Components of paper and paperboard in contact with 
    aqueous and fatty foods.
    
    * * * * *
        (a) * * *
        (5) * * *
    
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             List of Substances                      Limitations            
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      *                    *                    *                    *      
                       *                    *                    *          
    Perfluoroalkyl substituted           For use only as an oil and water   
     phosphate ester acids, ammonium      repellant at a level not to exceed
     salts formed by the reaction of      0.44 percent perfluoroalkyl       
     2,2-bis[(,-       actives by weight of the finished 
     perfluoroC4-20alkylthio)methyl]-     paper and paperboard in contact   
     1,3-propanediol, polyphosphoric      with non-alcoholic foods under    
     acid and ammonium hydroxide.         condition of use H as described in
                                          Table 2 of paragraph (c) of this  
                                          section; and in contact with food 
                                          of types III, IV-A, V, VII-A, and 
                                          IX described in Table 1 of        
                                          paragraph (c) of this section     
                                          under conditions of use C through 
                                          G as described in Table 2 of      
                                          paragraph (c) of this section.    
      *                    *                    *                    *      
                       *                    *                    *          
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    * * * * *
    
        Dated: February 7, 1997.
    Fred R. Shank,
    Director, Center for Food Safety and Applied Nutrition.
    [FR Doc. 97-5558 Filed 3-6-97; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Effective Date:
3/7/1997
Published:
03/07/1997
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule.
Document Number:
97-5558
Dates:
Effective March 7, 1997; written objections and requests for a hearing by April 7, 1997.
Pages:
10452-10453 (2 pages)
Docket Numbers:
Docket No. 96F-0242
PDF File:
97-5558.pdf
CFR: (1)
21 CFR 176.170