[Federal Register Volume 64, Number 20 (Monday, February 1, 1999)]
[Rules and Regulations]
[Pages 4785-4786]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2230]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 93F-0151]


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 MXD-6 as 
nonfood-contact layers of multilayer films and rigid plastic containers 
composed of polypropylene food-contact and exterior layers. This action 
is in response to a petition filed on behalf of Mitsubishi Gas Chemical 
Co., Inc.

DATES: This regulation is effective February 1, 1999; written 
objections and requests for a hearing by March 3, 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: Mark A. Hepp, Center for Food Safety 
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3098.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of May 19, 1993 (58 FR 29230), FDA announced that a food 
additive petition (FAP 3B4372) had been filed on behalf of Mitsubishi 
Gas Chemical Co., Inc., c/o 1001 G St. NW., suite 500 West, Washington, 
DC 20001. The petition proposed to amend the food additive regulations 
in Sec. 177.1390 Laminate structures for use at temperatures of 250 
deg.F and above (21 CFR 177.1390) and Sec. 177.1500 Nylon resins (21 
CFR 177.1500) to provide for the safe use of Nylon MXD-6 as a nonfood-
contact component in laminated articles for use in contact with food. 
However, the petition was subsequently amended to restrict the use of 
the subject additive to nonfood-contact layers of: (1) Multilayer films 
and (2) rigid plastic containers composed of polypropylene food-contact 
and exterior layers. This amendment is reflected in this final rule.
     FDA has evaluated data in the petition and other relevant 
material. The agency concludes that the proposed use of the additive as 
a nonfood-contact layer of: (1) Multilayer films and (2) rigid plastic 
containers composed of polypropylene food-contact and exterior layers 
is safe, that the additive will have the intended technical effect, and 
therefore, that 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 March 3, 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:

 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 redesignating paragraph 
(c)(1)(i)(e) as paragraph (c)(1)(i)(f) and adding a new paragraph 
(c)(1)(i)(e) to read as follows:


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

* * * * *
    (c) * * *
    (1) * * *
    (i) * * *
    (e) Nylon MXD-6 resins that comply with item 10.3 of the table in 
Sec. 177.1500(b) of this chapter when extracted with water and heptane 
under the conditions of time and temperature specified for condition of 
use A, as set

[[Page 4786]]

forth in Table 2 of Sec. 176.170(c) of this chapter.
* * * * *
     3. Section 177.1500 is amended in the table in paragraph (b) by 
adding item ``10.3'' to read as follows:


Sec. 177.1500   Nylon resins.

* * * * *
    (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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                                       *                  *                  *                  *                  *                  *                  *
10.3 Nylon MXD-6 resins for use only as        1.220.02
 films and (2) rigid plastic containers
 composed of polypropylene food-contact and
 exterior layers, as defined in Sec.
 177.1520(c), item 1.1(a) and 1.1(b), of this
 chapter. The finished food-contact laminate,
 in the form in which it contacts food, when
 extracted with the food simulating solvent
 or solvents characterizing the conditions of
 the intended use as determined from Table 2
 of Sec.  176.170(c) of this chapter, shall
 yield not more than 0.5 micrograms of m-
 xylylenediamine-adipic acid cyclic monomer
 per square inch of food-contact surface,
 when the food simulating solvent is analyzed
 by any appropriate, properly validated
 method.
 
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    Dated: January 20, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 99-2230 Filed 1-29-99; 8:45 am]
BILLING CODE 4160-01-F