[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