[Federal Register Volume 59, Number 64 (Monday, April 4, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-7883]
[[Page Unknown]]
[Federal Register: April 4, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 173
[Docket No. 89F-0031]
Secondary Direct Food Additives Permitted in Food for Human
Consumption; Perfluorinated Ion Exchange Membranes
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 a perfluorinated
ion exchange membrane intended for repeated use in the treatment of
bulk quantities of liquid foods at temperatures up to 70 deg.C (158
deg.C). The membrane is a copolymer of ethanesufonyl fluoride, 2-[1-
[difluoro-[(trifluoroethenyl)oxy]methyl]-1,2,2,2-tetrafluoroethoxy]-
1,1,2,2,-tetrafluoro- with tetrafluoroethylene that is subsequently
treated to hydrolyze the sulfonyl fluoride group to the sulfonic acid.
This action is in response to a petition filed by E. I. du Pont de
Nemours and Co.
DATES: Effective April 4, 1994; written objections and requests for a
hearing by May 4, 1994.
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: Julius Smith, Center for Food Safety
and Applied Nutrition (HFS-216), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-254-9500.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of February 21, 1989 (54 FR 7519), FDA announced that a food
additive petition (FAP 9B4123) had been filed by E.I. du Pont de
Nemours and Co., Wilmington, DE 19898. The petition proposed that the
food additive regulations in part 173 Secondary Direct Food Additives
Permitted in Food for Human Consumption (21 CFR part 173) be amended to
provide for the safe use of a fluorocarbon resin, manufactured by the
reaction of tetrafluoroethylene and perfluoro(4-methyl-3,6-dioxa-7-
octene-1-sulfonyl fluoride), and followed by hydrolysis of the sulfonyl
fluoride group to sulfonic acid, for use as a membrane to process 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 part 173 should be amended by adding new Sec. 173.21 to
subpart A, as set forth below. The additive was described in the filing
noitce by nomenclature commonly used in industry. In accordance with
agency policy, the listing in new Sec. 173.21 uses Chemical Abstracts
nomenclature.
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 May 4, 1994, 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 173
Food additives.
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 173 is amended as follows:
PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR
HUMAN CONSUMPTION
1. The authority citation for 21 CFR part 173 continues to read as
follows:
Authority: Secs. 201, 402, 409 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 342, 348).
2. New Sec. 173.21 is added to subpart A to read as follows:
Sec. 173.21 Perfluorinated ion exchange membranes.
Substances identified in paragraph (a) of this section may be
safely used as ion exchange membranes intended for use in the treatment
of bulk quantities of liquid food under the following prescribed
conditions:
(a) Identity. The membrane is a copolymer of ethanesulfonyl
fluoride, 2-[1-[difluoro-[(trifluoroethenyl)oxy]methyl]-1,2,2,2-
tetrafluoroethoxy]-1,1,2,2,-tetrafluoro-, with tetrafluoroethylene that
has been subsequently treated to hydrolyze the sulfonyl fluoride group
to the sulfonic acid. The Chemical Abstracts Service name of this
polymer is ethanesulfonic acid, 2-[1-[difluoro-
[(trifluoroethenyl)oxy]methyl]-1,2,2,2-tetrafluoroethoxy]-1,1,2,2,-
tetrafluoro-, polymer with tetrafluoroethane (CAS Reg. No. 31175-20-9).
(b) Optional adjuvant substances. The basic polymer identified in
paragraph (a) of this section may contain optional adjuvant substances
required in the production of such basic polymer. These optional
adjuvant substances may include substances used in accordance with
Sec. 174.5 of this chapter.
(c) Conditions of use. (1) Perfluorinated ion exchange membranes
described in paragraph (a) of this section may be used in contact with
all types of liquid foods at temperatures not exceeding 70 deg.C (158
deg.F).
(2) Maximum thickness of the copolymer membrane is 0.007 inch
(0.017 centimeter).
(3) Perfluorinated ion exchange membranes shall be maintained in a
sanitary manner in accordance with current good manufacturing practice
so as to prevent microbial adulteration of food.
(4) To assure their safe use, perfluorinated ionomer membranes
shall be thoroughly cleaned prior to their first use in accordance with
current good manufacturing practice.
Dated: March 24, 1994.
L. Robert Lake,
Acting Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-7883 Filed 4-1-94; 8:45 am]
BILLING CODE 4160-01-F
