[Federal Register Volume 62, Number 201 (Friday, October 17, 1997)]
[Rules and Regulations]
[Pages 53957-53958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-27527]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 93F-0111]


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 6/66 
copolymers as components of nonfood-contact layers of multilayer food 
packaging used at temperatures that do not exceed 212  deg.F. This 
action is in response to a petition filed by Allied-Signal, Inc.

DATES: The regulation is effective October 17, 1997; written objections 
and requests for a hearing by November 17, 1997.

ADDRESS: 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: 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 3, 1993 (58 FR 26325), FDA announced that a food 
additive petition (FAP 3B4369) had been filed by Allied-Signal, Inc., 
c/o 1100 G St. NW., Washington, DC 20001 (presently 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 
Sec. 177.1395 Laminate structures for use at temperatures between 120 
deg.F and 250  deg.F (21 CFR 177.1395) to provide for the safe use of 
Nylon 6/66 copolymers complying with 21 CFR 177.1500(b), item 4.2, as 
components of nonfood-contact layers of multilayer food packaging used 
at temperatures that do not exceed 100  deg.C (212  deg.F).

    In reviewing the environmental assessment (EA), the agency found 
that the petitioner's proposed regulation was much broader than the 
proposed use covered in the EA. Whereas the analysis in the EA 
considered only the use of Nylon 6/66 copolymers in laminate films, the 
petitioner proposed the use of these copolymers in laminate structures, 
which includes the use in laminate films. In a subsequent communication 
with the agency, the petitioner agreed that the proposed regulation 
should be narrowed to state specifically that the intended use of Nylon 
6/66 copolymers is in laminate films. Therefore, this regulation limits 
the use of these copolymers to laminate films, which is consistent with 
the proposed use covered in the EA.
    FDA has evaluated 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 
therefore, that the regulations in Sec. 177.1395 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.
    Any person who will be adversely affected by this regulation may at 
any time on or before November 17, 1997, 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: 21 U.S.C. 321, 342, 348, 379e.

    2. Section 177.1395 is amended in the table in paragraph (b)(4) by 
revising the entry for ``Nylon 6/66 resins complying with 
Sec. 177.1500(b), item 4.2 * * *'' to read as follows:

Sec. 177.1395  Laminate structures for use at temperatures between 120 
deg.F and 250  deg.F.

* * * * *
    (b) * * *
    (4) * * *

[[Page 53958]]



                                                                                                                
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                       Substances                                              Limitations                      
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  *                    *                    *                    *                    *                    *    
                                                             *                                                  
Nylon 6/66 resins complying with Sec.  177.1500(b),      For use only with:                                     
 item 4.2 of this chapter (CAS Reg. 24993-04-2).         1. Nonalcoholic foods at temperatures not to exceed    
                                                          82.2 C (180 F). Laminate structures with authorized   
                                                          food-contact materials yield no more than 0.15        
                                                          milligram of epsilon-caprolactam per square inch when 
                                                          extracted with water at 82.2 C (180 F) for 5 hours.   
                                                         2. Nonalcoholic foods at temperatures not to exceed 100
                                                          C (212 F). Laminate films with authorized food-contact
                                                          materials yield no more than 0.15 milligram of epsilon-
                                                          caprolactam per square inch when extracted with water 
                                                          at 100 C (212 F) for 5 hours.                         
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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    Dated: September 30, 1997.
Janice F. Oliver,
Deputy Director for Systems and Support, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 97-27527 Filed 10-16-97; 8:45 am]
BILLING CODE 4160-01-F