[Federal Register Volume 61, Number 245 (Thursday, December 19, 1996)]
[Rules and Regulations]
[Pages 66918-66919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32126]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 96F-0205]
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 additional safe use of 3,9-
bis[2-{3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propionyloxy}-1,1-
dimethylethyl]-2,4,8,10-tetraoxaspiro[5.5]undecane as an antioxidant
and/or stabilizer in propylene homopolymer and high-propylene olefin
copolymer articles intended for use in contact with food. This action
is in response to a petition filed by Sumitomo Chemical America, Inc.
DATES: Effective December 19, 1996; written objections and requests for
a hearing by January 21, 1997.
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: 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 3, 1996 (61 FR 34853), FDA announced that a food
additive petition (FAP 6B4510) had been filed by Sumitomo Chemical
America, Inc., c/o Keller and Heckman, 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 additional safe use of
3,9-bis[2-{3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propionyloxy}-1,1-
dimethylethyl]-2,4,8,10-tetraoxaspiro[5.5]undecane intended for use in
contact with food.
FDA has evaluated the data in the petition and other relevant
material. The agency concludes that the proposed use of the additive is
safe, that the food additive will have the intended technical effect,
and therefore, that 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 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 January 21, 1997, 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 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 ``3,9-Bis[2-{3-(3-tert-butyl-4-hydroxy-5-
methylphenyl)propionyloxy}-1,1-dimethylethyl]-2,4,8,10-
tetraoxaspiro[5.5]undecane'' by adding a new entry ``3.'' under the
heading ``Limitations'' to read as follows:
Sec. 178.2010 Antioxidants and/or stabilizers for polymers.
* * * * *
(b) * * *
[[Page 66919]]
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Substances Limitations
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3,9-Bis[2-{3-(3-tert-butyl-4- * * *
hydroxy-5- 3. At levels not to exceed 0.3
methylphenyl)propionyloxy}-1,1- percent by weight of olefin
dimethylethyl]-2,4,8,10- polymers complying with Sec.
tetraoxaspiro[5.5]undecane (CAS 177.1520(c) of this chapter, items
Reg. No. 90498-90-1). 1.1, 3.1, and 3.2, where the
copolymers complying with items
3.1 and 3.2 contain not less than
85 weight percent of polymer units
derived from propylene. The
finished polymer is to be used in
contact with food of types I, II,
IV-B, VI-A, VI-B, VI-C, VII-B, and
VIII under conditions of use A
through H described in Tables 1
and 2 of Sec. 176.170(c) of this
chapter.
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Dated: December 4, 1996.
Fred R. Shank,
Director, Center for Safety and Applied Nutrition.
[FR Doc. 96-32126 Filed 12-18-96; 8:45 am]
BILLING CODE 4160-01-F
