[Federal Register Volume 60, Number 226 (Friday, November 24, 1995)]
[Rules and Regulations]
[Pages 57926-57927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28545]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 177
[Docket No. 92F-0086]
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-1,4-
cyclohexylene dimethylene terephthalate copolymer containing up to 5
mole percent (7 weight percent) 1,4-cyclohexylene dimethylene
terephthalate as a base sheet and base polymer for use in food-contact
articles. This action is in response to a petition filed by Eastman
Chemical Co.
DATES: Effective November 24, 1995; written objections and requests for
a hearing by December 26, 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: Diane E. Robertson, Center for Food
Safety and Applied Nutrition (HFS-216), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3089.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of April 13, 1992 (57 FR 12831), FDA announced that a food
additive petition (FAP 2B4318) had been filed by Eastman Chemical Co.,
P.O. Box 511, Kingsport, TN 37662. The petition proposed to amend the
food additive regulations to provide for the safe use of copolyesters
containing up to 5 mole percent (7 weight percent) 1,4-cyclohexylene
dimethylene terephthalate as the base sheet and base polymer for use in
food-contact articles.
FDA has evaluated the data and information in the petition and
concludes that the proposed use of the additive as a base sheet and
base polymer is safe. The agency also concludes that the additive is
currently regulated under Sec. 177.1315 Ethylene-1,4-cyclohexylene
dimethylene terephthalate copolymers (21 CFR 177.1315) and that this
new use should be regulated under the same name. Further, the agency
concludes that both Secs. 177.1315 and 177.1630 Polyethylene phthalate
polymers (21 CFR 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 December 26, 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 177.1315 is amended in the table in paragraph (b) by
adding new entry ``3.'' to read as follows:
Sec. 177.1315 Ethylene-1,4-cyclohexylene dimethylene terephthalate
copolymers.
-* * * * *
(b) Specifications:
[[Page 57927]]
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Maximum
extractable
fractions of the
copolymer in the
finished form at
Ethylene 1,4-cyclohexylene specified
dimethylene terephthalate Inherent viscosity temperatures and Test for Conditions of use
copolymers times (expressed orientability
in micrograms of
the terephthaloyl
moieties/square
centimeter of food-
contact surface)
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* * * * * *
*
3. Ethylene-1,4-cyclohexylene No test required.. For each No test required.. For each
dimethylene terephthalate corresponding corresponding
copolymer is the reaction condition of use, specification,
product of dimethyl must meet may be used as a
terephthalate or terephthalic specifications base sheet and
acid with a mixture containing described in Sec. base polymer in
99 to 95 mole percent of 177.1630(f), accordance with
ethylene glycol and 1 to 5 mole (g), (h), or (j). conditions of use
percent of 1,4- described in Sec.
cyclohexanedimethanol (70 177.1630(f),
percent trans isomer, 30 (g), (h), or (j).
percent cis isomer).
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* * * * *
3. Section 177.1630 is amended by revising paragraphs (a), (b),
and the introductory text of paragraph (j) and by amending paragraph
(e)(4)(ii) by alphabetically adding a new substance to the ``List of
Substances and Limitations'' to read as follows:
Sec. 177.1630 Polyethylene phthalate polymers.
* * * * *-
(a) Polyethylene phthalate films consist of a base sheet of
ethylene terephthalate polymer, ethylene terephthalate-isophthalate
copolymer, or ethylene-1,4-cyclohexylene dimethylene terephthalate
copolyesters described in Sec. 177.1315(b)(3), to which have been added
optional substances, either as constituents of the base sheet or as
constituents of coatings applied to the base sheet.
(b) Polyethylene phthalate articles consist of a base polymer of
ethylene terephthalate polymer, or ethylene-1,4-cyclohexylene
dimethylene terephthalate copolyesters described in
Sec. 177.1315(b)(3), to which have been added optional substances,
either as constituents of the base polymer or as constituents of
coatings applied to the base polymer.
* * * * * -----
(e) * * *
(4) * * *
(ii) * * *
Ethylene-1,4-cyclohexylene dimethylene terephthalate copolyesters
described in Sec. 177.1315(b)(3).
* * * * *
(j) Polyethylene phthalate plastics, composed of ethylene
terephthalate-isophthalate containing a minimum of 98 weight percent of
polymer units derived from ethylene terephthalate, or ethylene-1,4-
cyclohexylene dimethylene terephthalate copolyesters described in
Sec. 177.1315(b)(3), conforming with the specifications prescribed in
paragraph (j)(1) of this section, are used as provided in paragraph
(j)(2) of this section.
Dated: November 10, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-28545 Filed 11-22-95; 8:45 am]
BILLING CODE 4160-01-F