[Federal Register Volume 64, Number 164 (Wednesday, August 25, 1999)]
[Rules and Regulations]
[Pages 46271-46272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21963]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 96F-0176]


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 6/12 
copolymer resins as nonfood-contact layers of laminated films and rigid 
multilaminate constructions with polypropylene outer layers intended 
for use in contact with food. This action is in response to a petition 
filed by Toray Industries (America) Inc.

DATES: The regulation is effective August 25, 1999; written objections 
and requests for a hearing by September 24, 1999.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Vivian M. Gilliam, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3167.

SUPPLEMENTARY INFORMATION:  In a notice published in the Federal 
Register of August 27, 1996 (61 FR 44067), FDA announced that a food 
additive petition (FAP 6B4505) had been filed by Toray Industries 
(America) Inc., c/o Keller and Heckman, 1001 G St. NW., suite 500 West, 
Washington, DC 20001. The petition proposed to amend the food additive 
regulations in Part 177 Indirect Food Additives: Polymers (21 CFR part 
177) to provide for the safe use of Nylon 6/12 copolymers for use as a 
non-food contact layer of laminated articles intended for use with 
food.
    FDA has evaluated data in the petition and other relevant material. 
Based on this information, the agency concludes that: (1) The proposed 
use of the additive as a non-food contact layer of laminated films and 
rigid multilaminate constructions where the outer layers are made of 
polypropylene is safe, (2) the additive will achieve its intended 
technical effect, and (3) the regulations in Secs. 177.1390 and 
177.1500 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.
    This final rule contains no collections 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 September 24, 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.

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:

[[Page 46272]]

PART 177--INDIRECT FOOD ADDITIVES: POLYMERS

    1. The authority citation for 21 CFR part 177 continues to read as 
follows:

     Authority: 21 U.S.C. 321, 342, 348, 379e.

     2. Section 177.1390 is amended by revising paragraph (c)(1)(i)(f) 
to read as follows:


Sec. 177.1390  Laminate structures for use at temperatures of 250 
deg.F and above.

* * * * *
    (c) * * *
    (1) * * *
    (i) * * *
    (f) Nylon 6/12 resins (CAS Reg. No. 25191-04-2) complying with item 
13.3 of the table in Sec. 177.1500(b), for use as nonfood-contact 
layers of laminated films and in rigid multilaminate constructions with 
polypropylene outer layers. Laminate structures with authorized food-
contact materials yield no more than 0.15 milligrams of epsilon-
caprolactam and 0.04 milligrams of omega-laurolactam per square inch 
when extracted with 95 percent ethanol at 121  deg.C (250  deg.F) for 2 
hours.
* * * * *
    3. Section 177.1500 is amended in the table in paragraph (b) by 
adding item ``13.3'' in numerical order to read as follows:


Sec. 177.1500   Nylon resins.

* * * * *
    (b) * * *

 
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                                                                     Maximum extractable fraction in selected
                                                                    solvents (expressed in percent by weight of
                          Melting point   Solubility   Viscosity                      resin)
   Nylon       Specific      (degrees     in boiling    No. (mL/ -----------------------------------------------
   resins      gravity     Fahrenheit)     4.2N HCl        g)                 95 percent
                                                                     Water       ethyl       Ethyl      Benzene
                                                                                alcohol     acetate
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*            *            *              *                 *          *           *           *           *
 13.3 Nylon  1.13