[Federal Register Volume 59, Number 27 (Wednesday, February 9, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-2881]
[[Page Unknown]]
[Federal Register: February 9, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 177
[Docket No. 93F-0058]
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
polymethylmethacrylate/poly(trimethoxysilylpropyl)methacrylate
copolymers as components of surface primers used in conjunction with
regulated silicone polymers in repeat-use, food-contact applications.
This action is in response to a petition filed by General Electric Co.
DATES: Effective February 9, 1994; written objections and requests for
a hearing by March 11, 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: Andrew J. Zajac, 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 April 22, 1993 (58 FR 21583), FDA announced that a food
additive petition (FAP 3B4362) had been filed by General Electric Co.,
c/o 700 13th St. NW., suite 1200, Washington, DC 20005. The petition
proposed that the food additive regulations be amended to provide for
the safe use of polymethylmethacrylate/
poly(trimethoxysilylpropyl)methacrylate copolymers as surface primers
with silicone polymers regulated in Sec. 175.300 Resinous and polymeric
coatings (21 CFR 175.300) and Sec. 177.2600 Rubber articles intended
for repeated use (21 CFR 177.2600).
FDA has evaluated data in the petition and other relevant material
and concludes that the proposed use of polymethylmethacrylate/
poly(trimethoxysilylpropyl)methacrylate copolymer is safe and that the
regulations should be amended by adding new Sec. 177.2465 (21 CFR
177.2465) 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 March 11, 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 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. New Sec. 177.2465 is added to subpart C to read as follows:
Sec. 177.2465 Polymethylmethacrylate/
poly(trimethoxysilylpropyl)methacrylate copolymers.
Polymethylmethacrylate/poly(trimethoxysilylpropyl) methacrylate
copolymers (CAS Reg. No. 26936-30-1) may be safely used as components
of surface primers used in conjunction with silicone polymers intended
for repeated use and complying with Sec. 175.300 of this chapter and
Sec. 177.2600, in accordance with the following prescribed conditions.
(a) Identity. For the purpose of this section,
polymethylmethacrylate/poly(trimethoxysilylpropyl)methacrylate
copolymers are produced by the polymerization of methylmethacrylate and
trimethoxysilylpropylmethacrylate.
(b) Conditions of use. (1) The polymethylmethacrylate/
poly(trimethoxysilylpropyl)methacrylate copolymers are used at levels
not to exceed 6.0 percent by weight of the primer formulation.
(2) The copolymers may be used in food contact applications with
all food types under conditions of use B through H as described in
Table 2 of Sec. 176.170(c) of this chapter.
Dated: January 31, 1994.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-2881 Filed 2-8-94; 8:45 am]
BILLING CODE 4160-01-F