[Federal Register Volume 60, Number 231 (Friday, December 1, 1995)]
[Rules and Regulations]
[Page 61654]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29219]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 93F-0166]


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 pyromellitic 
dianhydride as a modifier in the manufacture of polyethylene 
terephthalate copolymers intended for food-contact applications. This 
action is in response to a petition filed by M. & G. Ricerche S.p.A.

DATES: Effective December 1, 1995; written objections and requests for 
a hearing by January 2, 1996.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Vir D. Anand, Center for Food Safety 
and Applied Nutrition (HFS-216), 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 August 12, 1993 (58 FR 42975), FDA announced that a food 
additive petition (FAP 3B4375) had been filed by M. & G. Ricerche, 
S.p.A., c/o Keller and Heckman, 1001 G St. NW., suite 500 West, 
Washington, DC 20001 (formerly c/o Delta Analytical Corp., 7910 
Woodmont Ave., suite 1000, Bethesda, MD 20814). The petition proposed 
to amend the food additive regulations in Sec. 177.1630 Polyethylene 
phthalate polymers (21 CFR 177.1630) to provide for the safe use of 
pyromellitic dianhydride as a modifier in the manufacture of 
polyethylene terephthalate copolymers intended for food-contact 
applications.
    FDA has evaluated data in the petition and other relevant material. 
The agency concludes that the proposed food additive use in 
polyethylene terephthalate food-contact articles is safe, and the 
regulation in Sec. 177.1630 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 21 CFR 
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 January 2, 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 177.1630 is amended in paragraph (e)(4) by 
alphabetically adding a new substance to paragraph (i) in the ``List of 
Substances and Limitations'' to read as follows:


Sec. 177.1630  Polyethylene phthalate polymers.

* * * * *
    (e) * * *
    (4) * * *
List of Substances and Limitations
    (i) * * *
Ethylene terephthalate copolymers: Prepared by the condensation of 
dimethyl terephthalate or terephthalic acid with ethylene glycol, 
modified with one or more of the following: Azelaic acid, dimethyl 
azelate, dimethyl sebacate, sebacic acid, pyromellitic dianhydride. 
The level of pyromellitic dianhydride shall not exceed 0.5 percent 
by weight of the finished copolymer which may be used under 
conditions of use E through H as described in Table 2 of 
Sec. 176.170(c) of this chapter.
* * * * *

    Dated: November 21, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-29219 Filed 11-30-95; 8:45 am]
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