[Federal Register Volume 60, Number 69 (Tuesday, April 11, 1995)]
[Rules and Regulations]
[Pages 18352-18353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-8773]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 178
[Docket No. 91F-0499]
Indirect Food Additives: Adjuvants, Production Aids, and
Sanitizers
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 2,4-di-tert-pentyl-
6-[1-(3,5-di-tert-pentyl-2-hydroxyphenyl)ethyl]phenyl acrylate as an
antioxidant in the manufacture of polystyrene and rubber-modified
polystyrene articles that contact food. This action is in response to a
petition filed by Sumitomo Chemical America, Inc.
DATES: Effective April 11, 1995; written objections and requests for a
hearing by May 11, 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: Daniel N. Harrison, 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 January 30, 1992 (57 FR 3633), FDA announced that a food
additive petition (FAP 2B4295) had been filed by Sumitomo Chemical
America, Inc., 345 Park Ave., New York, NY 10154. The petition proposed
to amend the food additive regulations in Sec. 178.2010 Antioxidants
and/or stabilizers for polymers (21 CFR 178.2010) to provide for the
safe use of 2,4-di-tert-pentyl-6-[1-(3,5-di-tert-pentyl-2-
hydroxyphenyl)ethyl]phenyl acrylate as an antioxidant in the
manufacture of polystyrene and rubber-modified polystyrene articles
that contact food.
FDA has evaluated data in the petition and other relevant material.
The agency concludes that the proposed food additive use is safe, and
that the regulations in Sec. 178.2010(b) 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 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 11, 1995, 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
[[Page 18353]] between 9 a.m. and 4 p.m., Monday through Friday.
List of Subjects in 21 CFR Part 178
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 178 is amended as follows:
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND
SANITIZERS
1. The authority citation for 21 CFR part 178 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 178.2010 is amended in the table in paragraph (b) for
the entry ``2,4-di-tert-pentyl-6-[1-(3,5-di-tert-pentyl-2-
hydroxyphenyl)ethyl]phenyl acrylate'' by adding a new entry ``3.''
under the heading ``Limitations'' to read as follows:
Sec. 178.2010 Antioxidants and/or stabilizers for polymers.
* * * * *
(b) * * *
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Substances Limitations
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* * * * *
2,4-Di-tert-pentyl-6-[1-(3,5-di- For use only:
tert-pentyl-2-
hydroxyphenyl)ethyl]phenyl
acrylate (CAS Reg. No.123968-25-
2)..
* * *
3. At levels not to exceed 0.5
percent by weight of polystyrene
and rubber-modified polystyrene
complying with Sec. 177.1640 of
this chapter in contact with all
food types under conditions of use
D through G as described in Table
2 of Sec. 176.170(c) of this
chapter.
* * * * *
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Dated: April 3, 1995.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 95-8773 Filed 4-10-95; 8:45 am]
BILLING CODE 4160-01-F
