[Federal Register Volume 61, Number 113 (Tuesday, June 11, 1996)]
[Rules and Regulations]
[Pages 29474-29476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14697]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 177
[Docket No. 92F-0357]
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 polysulfone resins
identified as 1,1'-sulfonylbis[4-chlorobenzene] polymer with 4,4'-(1-
methylethylidene)bis[phenol] (minimum 92 percent) and 4,4'-
sulfonylbis[phenol] (maximum 8 percent) (CAS Reg. No. 88285-91-0)
consisting of basic resins produced when a mixture of 4,4'-
isopropylidenediphenol (minimum 92 percent) and 4,4'-
sulfonylbis[phenol]
[[Page 29475]]
(maximum 8 percent) is made to react with 4,4'-dichlorodiphenyl sulfone
in such a way that the finished resins have a minimum number average
molecular weight of 26,000, as determined by osmotic pressure in
dimethylformamide, as an article or component of articles for use in
contact with food. This action responds to a food additive petition
filed by BASF Corp.
DATES: Effective June 11, 1996; written objections and requests for a
hearing by July 11, 1996.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
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, 202-418-3094.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of November 17, 1992 (57 FR 54247), FDA announced that a food
additive petition (FAP 1B4262) had been filed by BASF Corp., 1609
Biddle Ave., Wyandotte, MI 48192-3799. The petition proposed to amend
the food additive regulations in Sec. 177.1655 Polysulfone resins (21
CFR 177.1655) to provide for the safe use of a polysulfone resin
consisting of 1,1'-sulfonylbis[4-chlorobenzene] polymer with 4,4'-(1-
methylethylidene)bis[phenol] and 4,4'-sulfonylbis[phenol], as an
article or component of articles intended for use in contact with food.
FDA has evaluated the data in the petition and other relevant
material. Based upon its review, the agency concludes that the food
additive is more appropriately identified as 1,1'-sulfonylbis[4-
chlorobenzene] polymer with 4,4'-(1-methylethylidene)bis[phenol]
(minimum 92 percent) and 4,4'-sulfonylbis[phenol] (maximum 8 percent)
(CAS Reg. No. 88285-91-0). FDA is therefore adopting this name for the
food additive in this final rule. The petitioner also requested an
amendment to the petition to adopt a 0.01 percent (100 parts per
million) limit for the residual solvent, N-methyl-2-pyrrolidone, in the
finished basic resin. The agency agrees that this is appropriate
limitation and, based upon the available data, concludes that the
proposed food additive use is safe and that the additive will achieve
its intended technical effect. Therefore, FDA further concludes that
Sec. 177.1655 should be amended to revise paragraph (a), and in the
table in paragraph (b) to add N-methyl-2-pyrrolidone and to revise the
limitations.
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 July 11, 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 177.1655 is amended by revising paragraph (a) and the
table in paragraph (b) to read as follows:
Sec. 177.1655 Polysulfone resins.
* * * * *
(a) For the purpose of this section, polysulfone resins are:
(1) Poly(oxy-p-phenylenesulfonyl-p-phenyleneoxy-p-
phenyleneisopropylidene-p-phenylene) resins (CAS Reg. No. 25154-01-2)
consisting of basic resins produced when the disodium salt of 4,4'-
isopropylidenediphenol is made to react with 4,4'-dichlorodiphenyl
sulfone in such a way that the finished resins have a minimum number
average molecular weight of 15,000, as determined by osmotic pressure
in monochlorobenzene; or
(2) 1,1'-Sulfonylbis[4-chlorobenzene] polymer with 4,4'-(1-
methylethylidene)bis[phenol] (minimum 92 percent) and 4,4'-
sulfonylbis[phenol] (maximum 8 percent) (CAS Reg. No. 88285-91-0)
produced when a mixture of 4,4'-isopropylidenediphenol (minimum 92
percent) and 4,4'-sulfonylbis[phenol] (maximum 8 percent) is made to
react with 4,4'-dichlorodiphenyl sulfone in such a way that the
finished resin has a minimum number average molecular weight of 26,000,
as determined by osmotic pressure in dimethylformamide.
* * * * *
(b) * * *
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List of substances Limitations
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Dimethyl sulfoxide........................ Not to exceed 50 parts per
million as residual solvent
in finished basic resin in
paragraph (a)(1) of this
section.
[[Page 29476]]
Monochlorobenzene......................... Not to exceed 500 parts per
million as residual solvent
in finished basic resin in
paragraph (a)(1) of this
section.
N-methyl-2-pyrrolidone.................... Not to exceed 0.01 percent
(100 parts per million) as
residual solvent in
finished basic resin in
paragraph (a)(2) of this
section.
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* * * * *
Dated: May 17, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-14697 Filed 6-10-96; 8:45 am]
BILLING CODE 4160-01-F
