[Federal Register Volume 61, Number 128 (Tuesday, July 2, 1996)]
[Rules and Regulations]
[Pages 34370-34371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16769]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 93F-0167]


Indirect Food Additives: Polymers

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 Nylon 46 resins, 
which are manufactured by the condensation of 1,4-butanediamine and 
adipic acid, in membrane filters intended to contact beverages 
containing not more than 13 percent alcohol. This action responds to a 
petition filed by DSM Engineering Plastics.

DATES: Effective July 2, 1996; written objections and requests for a 
hearing by August 1, 1996.

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: Julius Smith, Center for Food Safety 
and Applied Nutrition (HFS-216), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3091.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of June 17, 1993 (58 FR 33447), FDA announced that a petition 
(FAP 3B4374) had been filed by DSM Engineering Plastics, 501 Crescent 
Ave., Reading, PA 19512-5051 (currently c/o Keller and Heckman, 1001 G 
St. NW., suite 500 West, Washington, DC 20001). The petitioner proposed 
to amend the food additive regulations in Sec. 177.1500 Nylon resins 
(21 CFR 177.1500) to provide for the safe use of Nylon 46 resins, which 
are manufactured by the condensation of 1,4-butanediamine and adipic 
acid, in membrane filters intended to contact alcoholic beverages.
    FDA has evaluated the data in the petition and other relevant 
material. The agency concludes that the proposed use of the additive is 
safe and that Sec. 177.1500 should therefore 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 August 1, 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 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 177

    Food additives, Food packaging.


[[Page 34371]]


    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 177 is amended as follows:

PART 177--INDIRECT FOOD ADDITIVES: POLYMERS

    1. The authority citation for 21 CFR part 177 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 177.1500 is amended by adding new paragraph (a)(15) and 
in the table in paragraph (b) by adding new entry ``15'' to read as 
follows:


Sec. 177.1500  Nylon resins.

* * * * *
    (a) *  *  *
    (15) Nylon 46 resins (CAS Reg. No. 50327-77-0) are manufactured by 
the condensation of 1,4-butanediamine and adipic acid.
    (b) *  *  *

                                                                                                                                                                                                
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                                                                                                                              Maximum extractable fraction in selected solvents (expressed in   
                                                                 Melting point                                                                  percent by weight of resin)                     
                 Nylon resins                     Specific          (degrees        Solubility in     Viscosity No. (mL/ -----------------------------------------------------------------------
                                                   gravity        Fahrenheit)      boiling 4.2N HCL           g)                       95 percent ethyl                                         
                                                                                                                            Water          alcohol            Ethyl acetate          Benzene    
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                                *                    *                    *                    *                    *                    *                    *                                 
15. Nylon 46 resins for use only in food-      1.18 plus-      551-592            Dissolves in 1     ...................  0.3        0.2                  0.2                   0.3             
 contact membrane filters intended for          minus 0.015                        hour                                                                                                         
 repeated use. The finished membrane filter                                                                                                                                                     
 is intended to contact beverages containing                                                                                                                                                    
 no more than 13 percent alcohol, under                                                                                                                                                         
 conditions of use E, F, and G listed in                                                                                                                                                        
 table 2 of Sec.  176.170(c) of this chapter.                                                                                                                                                   
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* * * * *

    Dated: June 12, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-16769 Filed 7-1-96; 8:45 am]
BILLING CODE 4160-01-F