[Federal Register Volume 61, Number 129 (Wednesday, July 3, 1996)]
[Notices]
[Pages 34852-34853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16976]
-----------------------------------------------------------------------
[[Page 34853]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96F-0205]
Sumitomo Chemical America, Inc.; Filing of Food Additive Petition
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that
Sumitomo Chemical America, Inc., has filed a petition proposing that
the food additive regulations be amended 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.
DATES: Written comments on the petitioner's environmental assessment by
August 2, 1996.
ADDRESSES: Submit written comments 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: Under the Federal Food, Drug, and Cosmetic
Act (sec. 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food
additive petition (FAP 6B4510) has been filed by Sumitomo Chemical
America, Inc., c/o Keller and Heckman, 1001 G St. NW., suite 500 West,
Washington, DC 20001. The petition proposes 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 as an antioxidant
and/or stabilizer in propylene homopolymer and high-propylene olefin
copolymer articles intended for use in contact with food.
The potential environmental impact of this action is being
reviewed. To encourage public participation consistent with regulations
promulgated under the National Environmental Policy Act (40 CFR
1501.4(b)), the agency is placing the environmental assessment
submitted with the petition that is the subject of this notice on
display at the Dockets Management Branch (address above) for public
review and comment. Interested persons may, on or before August 2,
1996, submit to the Dockets Management Branch (address above) written
comments. Two copies of any comments are to be submitted, except that
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the office above between 9 a.m. and 4
p.m., Monday through Friday. FDA will also place on public display any
amendments to, or comments on, the petitioner's environmental
assessment without further announcement in the Federal Register. If,
based on its review, the agency finds that an environmental impact
statement is not required and this petition results in a regulation,
the notice of availability of the agency's finding of no significant
impact and the evidence supporting that finding will be published with
the regulation in the Federal Register in accordance with 21 CFR
25.40(c).
Dated: June 17, 1996.
George H. Pauli,
Acting Director, Office of Premarket Approval, Center for Food Safety
and Applied Nutrition.
[FR Doc. 96-16976 Filed 7-2-96; 8:45 am]
BILLING CODE 4160-01-F
