98-32907. Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers  

  • [Federal Register Volume 63, Number 238 (Friday, December 11, 1998)]
    [Rules and Regulations]
    [Pages 68391-68393]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 98-32907]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    
    21 CFR Part 178
    
    [Docket No. 98F-0291]
    
    
    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 sodium 
    2,2'-methylenebis(4,6-di-tert-butylphenyl)phosphate as a clarifying 
    agent in olefin polymers intended for use in contact with food. This 
    action is in response to a petition filed by Asahi Denka Kogyo K.K.
    
    DATES: The regulation is effective December 11, 1998; written 
    objections and requests for a hearing by January 11, 1999.
    
    ADDRESSES: Submit written objections to the Dockets Management Branch 
    (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
    Rockville, MD 20852.
    
    
    [[Page 68392]]
    
    
    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 May 7, 1998 (63 FR 25212), FDA announced that a food 
    additive petition (FAP 8B4592) had been filed by Asahi Denka Kogyo 
    K.K., 5-2-13, Shirahata, Urawa City, Saitama 336, Japan. The petition 
    proposed to amend the food additive regulations in Sec. 178.3295 
    Clarifying agents for polymers (21 CFR 178.3295) to provide for the 
    expanded safe use of sodium 2,2'-methylenebis(4,6-di-tert-
    butylphenyl)phosphate as a clarifying agent in olefin polymers intended 
    for use in contact with food (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 achieve 
    its intended technical effect, and therefore, that the regulations in 
    Sec. 178.3295 should be amended as set forth below.
        FDA's review of this petition indicates that the additive may 
    contain trace amounts of formaldehyde as an impurity. The potential 
    carcinogenicity of formaldehyde was reviewed by the Cancer Assessment 
    Committee (the Committee) of FDA's Center for Food Safety and Applied 
    Nutrition. The Committee noted that for many years, formaldehyde has 
    been known to be a carcinogen by the inhalation route, but the 
    Committee concluded that these inhalation studies are not appropriate 
    for assessing the potential carcinogenicity of formaldehyde in food. 
    The Committee's conclusion was based on the fact that the route of 
    administration (inhalation) is not relevant to the safety of 
    formaldehyde residues in food and the fact that tumors were observed 
    only locally at the portal of entry (nasal turbinates). In addition, 
    the agency has received literature reports of two drinking water 
    studies on formaldehyde: (1) A preliminary report of a carcinogenicity 
    study purported to be positive by Soffritti et al. (1989), conducted in 
    Bologna, Italy (Ref. 1); and (2) a negative study by Til et al. (1989), 
    conducted in The Netherlands (Ref. 2). The Committee reviewed both 
    studies and concluded, concerning the Soffritti study, ``* * * that 
    data reported were unreliable and could not be used in the assessment 
    of the oral carcinogenicity of formaldehyde'' (Ref. 3). This conclusion 
    is based on a lack of critical detail in the study, questionable 
    histopathological conclusions, and the use of unusual nomenclature to 
    describe the tumors. Based on the Committee's evaluation, the agency 
    has determined that there is no basis to conclude that formaldehyde is 
    a carcinogen when ingested.
        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 previously considered the environmental effects of 
    this rule as announced in the notice of filing for FAP 8B4592 (63 FR 
    25212). No new information or comments have been received that would 
    affect the agency's previous determination that there is no significant 
    impact on the human environment and that an environmental impact 
    statement is not required.
        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.
        Any person who will be adversely affected by this regulation may at 
    any time on or before January 11, 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.
    
    References
    
        The following references have been placed on display in the Dockets 
    Management Branch (address above) and may be seen by interested persons 
    between 9 a.m and 4 p.m., Monday through Friday.
        1. Soffritti, M., C. Maltoni, F. Maffei, and R. Biaggi, 
    ``Formaldehyde: An Experimental Multipotential Carcinogen,'' 
    Toxicology and Industrial Health, vol. 5, No. 5, pp. 699-730, 1989.
        2. Til, H. P., R. A. Woutersen, V. J. Feron, V. H. M. 
    Hollanders, H. E. Falke, and J. J. Clary, ``Two-Year Drinking Water 
    Study of Formaldehyde in Rats,'' Food Chemical Toxicology, vol. 27, 
    No. 2, pp. 77-87, 1989.
        3. Memorandum of Conference concerning ``Formaldehyde;'' Meeting 
    of the Cancer Assessment Committee, FDA, April 24, 1991, and March 
    4, 1993.
    
    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, 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 178.3295 is amended in the table in the entry for 
    ``Sodium 2,2'-methylenebis (4,6-di-tert-butylphenyl)phosphate'' by 
    revising entry ``2.'' under the heading ``Limitations'' to read as 
    follows:
    
    
    Sec. 178.3295   Clarifying agents for polymers.
    
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    [[Page 68393]]
    
    
    
     
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                 Substances                          Limitations
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    Sodium 2,2'-methylenebis(4,6-di-     For use only:
     tert-butylphenyl)phosphate (CAS     1. * * *
     Reg. No. 85209-91-2).               2. As a clarifying agent at levels
                                          not exceeding 0.10 percent by
                                          weight of polypropylene complying
                                          with Sec.  177.1520(c) of this
                                          chapter, items 1.1(a) or 1.1(b)
                                          and of olefin polymers complying
                                          with Sec.  177.1520(c) of this
                                          chapter, items 3.1(a), 3.1(b),
                                          3.1(c), 3.2(a), or 3.2(b) (where
                                          the copolymers contain not less
                                          than 85 weight percent of the
                                          polymer units derived from
                                          polypropylene.) The finished
                                          polymers shall be used in contact
                                          with foods only under conditions
                                          of use A through H described in
                                          Table 2 of Sec.  176.170(c) of
                                          this chapter.
      *                    *                    *                    *
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        Dated: December 1, 1998.
    William K. Hubbard,
    Associate Commissioner for Policy Coordination.
    [FR Doc. 98-32907 Filed 12-10-98; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Effective Date:
12/11/1998
Published:
12/11/1998
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule.
Document Number:
98-32907
Dates:
The regulation is effective December 11, 1998; written objections and requests for a hearing by January 11, 1999.
Pages:
68391-68393 (3 pages)
Docket Numbers:
Docket No. 98F-0291
PDF File:
98-32907.pdf
CFR: (1)
21 CFR 178.3295