[Federal Register Volume 59, Number 232 (Monday, December 5, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29854]
[[Page Unknown]]
[Federal Register: December 5, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 177
[Docket No. 91F-0198]
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 ethylene/1,3-
phenylene oxyethylene isophthalate/terephthalate copolymer in blends
with polyethylene terephthalate polymers in contact with food. This
action is in response to a petition filed by Mitsui Petrochemical
Industries, Ltd.
DATES: Effective December 5, 1994; written objections and requests for
a hearing by January 4, 1995.
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: Richard H. White, Center for Food
Safety and Applied Nutrition (HFS-216), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-254-9511.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of July 23, 1991 (56 FR 33761), FDA announced that a food
additive petition (FAP 1B4236) had been filed by Mitsui Petrochemical
Industries, Ltd., Kasumigaseki Bldg., P.O. Box 90, 2-5 Kasumigaseki 3-
chome, Chiyoda-ku, Tokyo 100, Japan. The petition proposed that the
food additive regulations in Sec. 177.1345 Ethylene/1,3-phenylene
oxyethylene isophthalate/terephthalate copolymer (21 CFR 177.1345) be
amended to provide for the safe use of ethylene/1,3-phenylene
oxyethylene isophthalate/terephthalate copolymer in blends with
polyethylene terephthalate polymers in contact with food.
FDA has evaluated data in the petition and other relevant material.
The agency concludes that the proposed use of the food additive is safe
and that the regulations in Sec. 177.1345 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 4, 1995, 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 177.1345 is amended by revising the introductory text
and by adding new paragraph (d) to read as follows:
Sec. 177.1345 Ethylene/1,3-phenylene oxyethylene isophthalate/
terephthalate copolymer.
Ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate
copolymer (CAS Reg. No. 87365-98-8) identified in paragraph (a) of this
section may be safely used, subject to the provisions of this section,
as the non-food-contact layer of laminate structures subject to the
provisions of Sec. 177.1395, and in blends with polyethylene
terephthalate polymers complying with Sec. 177.1630.
* * * * *
(d) Limitations. Copolymer blends described above shall not exceed
30 percent by weight of ethylene/1,3-phenylene oxyethylene
isophthalate/terephthalate copolymer. The finished blend may be used in
contact with food only under conditions of use C through G, as
described in Table 2 of Sec. 176.170(c) of this chapter, except that
with food identified as Type III, IV-A, V, VIII-A, and IX in
Sec. 176.170(c), Table 1, the copolymer may be used under condition of
use C at temperatures not to exceed 160 deg.F (71 deg.C).
* * * * *
Dated: November 18, 1994.
Raymond E. Newberry,
Acting Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-29854 Filed 12-2-94; 8:45 am]
BILLING CODE 4160-01-F
