[Federal Register Volume 64, Number 192 (Tuesday, October 5, 1999)]
[Rules and Regulations]
[Pages 53925-53926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25790]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 99F-1422]
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 expanded safe use of 2,4-di-
tert-pentyl-6-[1-(3,5-di-tert-pentyl-2-hydroxyphenyl)ethyl]phenyl
acrylate as an antioxidant and/or stabilizer for polypropylene,
polystyrene, rubber-modified polystyrene, and styrene block copolymers
intended for use in contact with food. This action responds to a
petition filed by Sumitomo Chemical Co., Ltd.
DATES: This regulation is effective October 5, 1999. Submit written
objections and requests for a hearing by November 4, 1999.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Vir D. Anand, Center for Food Safety
and Applied Nutrition (HFS-215), 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 May 26, 1999 (64 FR 28501), FDA announced that a food
additive petition (FAP 9B4661) had been filed by Sumitomo Chemical Co.,
Ltd., c/o Keller and Heckman LLP, 1001 G St. NW., suite 500 West,
Washington, DC 20001. 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 expanded safe use of 2,4-
di-tert-pentyl-6-[1-(3,5-di-tert-pentyl-2-hydroxyphenyl)ethyl]phenyl
acrylate as an antioxidant and/or stabilizer for polypropylene,
polystyrene, rubber-modified polystyrene, and styrene block copolymers
intended for use in contact with food.
FDA has evaluated the data in the petition and other relevant
material. Based on this information, the agency concludes that: (1) The
proposed use of the additive is safe, (2) the additive will achieve its
intended technical effect, and therefore, (3) the regulations in
Sec. 178.2010 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 Sec. 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 previously considered the environmental effects of
this rule as announced in the notice of filing for FAP 9B4661 (64 FR
28501). No new information or comments have been received that would
affect the agency's previous determination that there is no significant
impact on the human environment and that an environmental impact
statement is not required.
This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
Any person who will be adversely affected by this regulation may at
any time on or before November 4, 1999, 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
[[Page 53926]]
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 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: 21 U.S.C. 321, 342, 348, 379e.
2. Section 178.2010 is amended in the table in paragraph (b) by
revising the entry for ``2,4-Di-tert-pentyl-6-[1-(3,5-di-tert-pentyl-2-
hydroxyphenyl)ethyl]phenyl acrylate'' 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- 1. At levels not to exceed 0.2
hydroxyphenyl)ethyl]phenyl percent by weight of polypropylene
acrylate (CAS Reg. No. 123968-25- complying with Sec. 177.1520 of
2). this chapter in contact with food
under conditions of use D through
G as described in Table 2 of Sec.
176.170(c) of this chapter, except
that polypropylene containing the
additive at levels not to exceed
0.075 percent by weight may
contact food under conditions of
use A through H described in Table
2 of Sec. 176.170(c) of this
chapter.
2. At levels not to exceed 1.0
percent by weight of of styrene
block polymers complying with Sec.
177.1810 of this chapter. The
additive is used under conditions
of use D through G as described in
Table 2 of Sec. 176.170(c) of
this chapter.
3. At levels not to exceed 1.0
percent by weight of polystyrene
and rubber modified polystyrene
complying with Sec. 177.1640 of
this chapter in contact with food
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: September 21, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 99-25790 Filed 10-4-99; 8:45 am]
BILLING CODE 4160-01-F