[Federal Register Volume 60, Number 182 (Wednesday, September 20, 1995)]
[Rules and Regulations]
[Pages 48648-48650]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23248]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 177
[Docket No. 92F-0237]
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 1,1'-sulfonylbis[4-
chlorobenzene] polymer with 4,4'-(1-methylethylidene)bis[phenol]
(maximum 8 percent) and 4,4'-sulfonylbis[phenol] (minimum 92 percent)
as repeat-use articles or components of repeat-use articles that
contact food. This action is in response to a petition filed by BASF
Corp.
DATES: Effective September 20, 1995; written objections and requests
for a hearing by October 20, 1995. The Director of the Office of the
Federal Register approves the incorporation by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51 of a certain publication listed
in Sec. 177.2440, effective September 20, 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: Vir D. Anand, Center for Food Safety
and Applied Nutrition (HFS-216), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3081.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of July 8, 1992 (57 FR 30224), FDA announced that a food
additive petition (FAP 1B4263) had been filed by BASF Corp., 1609
Biddle Ave., Wyandotte, MI 48192-3799. The petition proposed to amend
the food additive regulations in Sec. 177.2440 Polyethersulfone resins
(21 CFR 177.2440) to provide for the safe use of 1,1'-sulfonylbis[4-
chlorobenzene] polymer with 4,4'-(1-methylethylidene)bis[phenol]
(maximum 8 percent) and 4,4'-sulfonylbis[phenol] (minimum 92 percent)
as repeat-use articles or components of repeat-use articles that
contact food.
FDA has evaluated the data in the petition and other relevant
material. The agency concludes that the proposed use of the food
additive is safe and that Sec. 177.2440 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
[[Page 48649]]
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 October 20, 1995, file with the Dockets
Management Branch (address above) written objection 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 objection 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 177.2440 is amended by revising paragraphs (a) and (b)
to read as follows:
Sec. 177.2440 Polyethersulfone resins.
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(a) For the purpose of this section, polyethersulfone resins are:
(1) Poly(oxy-p-phenylenesulfonyl-p-phenylene) resins (CAS Reg. No.
25667-42-9), which have a minimum number average molecular weight of
16,000.
(2) 1,1'-sulfonylbis[4-chlorobenzene] polymer with 4,4'-(1-
methylethylidene)bis[phenol] (maximum 8 percent) and 4,4'-
sulfonylbis[phenol] (minimum 92 percent) (CAS Reg. No. 88285-91-0),
which have a minimum number average molecular weight of 26,000.
(3) In paragraphs (a)(1) and (a)(2) of this section, the minimum
number average molecular weight is determined by reduced viscosity in
dimethyl formamide in accordance with ASTM method D2857-70 (Reapproved
1977), ``Standard Test Method for Dilute Solution Viscosity of
Polymers,'' which is incorporated by reference. Copies may be obtained
from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Division of Petition
Control (HFS-215), Center for Food Safety and Applied Nutrition, 1110
Vermont Ave. NW., suite 1200, Washington, DC, or at the Office of the
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
[[Page 48650]]
(b) The basic resins identified in paragraphs (a)(1) and (a)(2) of
this section may contain optional adjuvant substances described in
Sec. 174.5(d) of this chapter and the following:
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List of substances Limitations
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Diphenylsulfone.................... Not to exceed 0.2 percent as
residual solvent in the finished
basic resin described in paragraph
(a)(1) of this section.
Dimethyl sulfoxide................. Not to exceed 0.01 percent as
residual solvent in the finished
basic resin described in paragraph
(a)(1) of this section.
N-methyl-2-pyrrolidone............. Not to exceed 0.01 percent as
residual solvent in the finished
basic resin described in paragraph
(a)(2) of this section.
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Dated: September 6, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-23248 Filed 9-19-95; 8:45 am]
BILLING CODE 4160-01-F