[Federal Register Volume 61, Number 201 (Wednesday, October 16, 1996)]
[Rules and Regulations]
[Pages 53852-53854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-26516]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 95F-0201]


Indirect Food Additive: 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 poly(trimethyl 
hexamethylene terephthalamide) as a component of articles intended for 
food-contact use. This action is in response to a petition filed by 
Huls Aktiengesellschaft (Huls AG).

DATES: Effective October 16, 1996; written objections and requests for 
a hearing by November 15, 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: Mark A. Hepp, Center for Food Safety 
and Applied Nutrition (HFS-216), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3098.


[[Page 53853]]


SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of August 18, 1995 (60 FR 43157), FDA announced that a food 
additive petition (FAP 2B4328) had been filed by Huls 
Aktiengesellschaft, Marl, Germany (currently c/o Huls America, Inc., 
Turner Pl., P.O. Box 365, Piscataway, NJ 08855-0365). The petition 
proposed to amend the food additive regulations in Sec. 177.1500 Nylon 
resins (21 CFR 177.1500) to provide for the safe use of poly(trimethyl 
hexamethylene terephthalamide) as a component of articles intended for 
food-contact uses. However, the petition was subsequently amended to 
restrict the use of the subject additive to repeat-use articles that do 
not include reusable bottles. Therefore, this final rule will amend the 
regulations to authorize the use of the additive in repeat-use articles 
excluding reusable bottles.
    FDA has evaluated data in the petition and other relevant material. 
The agency concludes that the proposed use of the additive in repeat-
use articles (excluding bottles) is safe and that the additive will 
have the intended technical effect. The agency has also determined, 
with the petitioner's concurrence, that the additive should be listed 
by its classification name, Nylon resin PA 6-3-T. Therefore, 
Sec. 177.1500 will 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 November 15, 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.
    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)(16), in 
the table in paragraph (b) by adding a new entry ``16.'', and in the 
first sentence in paragraph (c)(5)(ii) by removing the word ``resin'' 
the first time it appears and by adding in its place the phrase ``and 
Nylon PA-6-3-T resins'' to read as follows:


Sec. 177.1500  Nylon resins.

* * * * *
    (a) * * *
    (16) Nylon resins PA 6-3-T (CAS Registry No. 26246-77-5) are 
manufactured by the condensation of 50 mol percent 1,4-
benzenedicarboxylic acid, dimethyl ester and 50 mol percent of an 
equimolar mixture of 2,2,4-trimethyl-1,6-hexanediamine and 2,4,4-
trimethyl-1,6-hexanediamine.
    (b) * * *

                                                                                                                                                        
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                                                                                            Maximum extractable fraction in selected solvents (expressed
                                              Melting                                                      in percent by weight of resin)               
                                 Specific      point        Solubility in      Viscosity  --------------------------------------------------------------
         Nylon resins            gravity      (degrees     boiling 4.2N HCl    No. (mL/g)               95 percent                                      
                                            Fahrenheit)                                       Water       ethyl        Ethyl             Benzene        
                                                                                                         alcohol      acetate                           
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            *                    *                    *                    *                    *                    *                    *             
16. Nylon resins PA 6-3-T for  1.12plus-mi          NA    Insoluble after 1        > 110       0.007         0.64        0.003   0                      
 repeated-use (excluding            n0.03                                h.                                                                             
 bottles) in contact with                                                                                                                               
 food of type VIA and VIB                                                                                                                               
 described in Table 1 of Sec.                                                                                                                           
  176.170(c) of this chapter                                                                                                                            
 under conditions of use D                                                                                                                              
 through H described in Table                                                                                                                           
 2 of Sec.  176.170(c) of                                                                                                                               
 this chapter with a hot-fill                                                                                                                           
 temperature limitation of 40                                                                                                                           
 C.                                                                                                                                                     
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[[Page 53854]]

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    Dated: October 3, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-26516 Filed 10-15-96; 8:45 am]
BILLING CODE 4160-01-F