96-942. Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers  

  • [Federal Register Volume 61, Number 16 (Wednesday, January 24, 1996)]
    [Rules and Regulations]
    [Pages 1829-1830]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-942]
    
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    
    21 CFR Part 178
    
    [Docket No. 95F-0172]
    
    
    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 disodium 
    decanedioate as a corrosion/rust preventative for greases used as 
    lubricants with incidental food contact. This action is in response to 
    a petition filed by Ciba-Geigy Corp.
    
    DATES: Effective January 24, 1996; written objections and requests for 
    a hearing by February 23, 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 July 20, 1995 (60 FR 37453), FDA announced that a food 
    additive petition 
    
    [[Page 1830]]
    (FAP 5B4466) had been filed by Ciba-Geigy Corp., Seven Skyline Dr., 
    Hawthorne, NY 10532-2188. The petition proposed to amend the food 
    additive regulations in Sec. 178.3570 Lubricants with incidental food 
    contact (21 CFR 178.3570) to provide for the safe use of disodium 
    decanedioate as a corrosion/rust preventative for greases used as 
    lubricants with incidental food contact.
        FDA has evaluated the data in the petition and other relevant 
    material. The agency concludes that the proposed use of the additive is 
    safe, that the additive will have the intended technical effect, and 
    that the regulations in Sec. 178.3570 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 February 23, 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 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 178.3570 is amended in the table in paragraph (a)(3) by 
    revising the entry for ``Disodium decanedioate'' under the heading 
    ``Limitations'' to read as follows:
    
    
    Sec. 178.3570  Lubricants with incidental food contact.
    
    * * * * *
        (a) * * *
        (3) * * *
    
                                                                            
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                   Substances                          Limitiations         
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      *                    *                    *                    *      
                       *                    *                    *          
    Disodium decanedioate (CAS Reg. No.      For use only:                  
     17265-14-4).                                                           
                                             1. As a corrosion inhibitor or 
                                              rust preventative in mineral  
                                              oil-bentonite lubricants at a 
                                              level not to exceed 2 percent 
                                              by weight of the grease.      
                                             2. As a corrosion inhibitor or 
                                              rust preventative only in     
                                              greases at a level not to     
                                              exceed 2 percent by weight of 
                                              the grease.                   
      *                    *                    *                    *      
                       *                    *                    *          
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    * * * * *
    
        Dated: January 3, 1996.
    Fred R. Shank,
    Director, Center for Food Safety and Applied Nutrition.
    [FR Doc. 96-942 Filed 1-23-96; 8:45 am]
    BILLING CODE 4160-01-F
    
    

Document Information

Effective Date:
1/24/1996
Published:
01/24/1996
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule.
Document Number:
96-942
Dates:
Effective January 24, 1996; written objections and requests for a hearing by February 23, 1996.
Pages:
1829-1830 (2 pages)
Docket Numbers:
Docket No. 95F-0172
PDF File:
96-942.pdf
CFR: (1)
21 CFR 178.3570