[Federal Register Volume 62, Number 193 (Monday, October 6, 1997)]
[Notices]
[Pages 52136-52137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-26452]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97F-0412]
Mitsui Petrochemical Industries, Ltd.; Filing of Food Additive
Petition
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that
Mitsui Petrochemical Industries, Ltd., has filed a petition proposing
that the food additive regulations be amended to provide for the safe
use of ethylene/propylene copolymers that contain up to 20 mole-percent
of polymer units derived from propylene, with the remainder of the
polymer consisting of ethylene, and having a minimum viscosity-average
molecular weight of 95,000 and a minimum Mooney viscosity of 13 at up
to 30 percent of other regulated polymer blends.
DATES: Written comments on the petitioner's environmental assessment by
November 5, 1997.
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: Hortense S. Macon, Center for Food
Safety and Applied Nutrition (HFS-215), Food and Drug Administration,
[[Page 52137]]
200 C St. SW., Washington, DC 20204, 202-418-3086.
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 7B4549) has been filed by Mitsui Petrochemical
Industries, Ltd., c/o Keller and Heckman LLP, 1001 G St. NW., suite 500
West, Washington, DC 20001. The petition proposes to amend the food
additive regulations in Sec. 177.1520 Olefin polymers (21 CFR 177.1520)
to provide for the safe use of ethylene/propylene copolymers that
contain up to 20 mole-percent of polymer units derived from propylene,
with the remainder of the polymer consisting of ethylene, and having a
minimum viscosity-average molecular weight of 95,000 and a minimum
Mooney viscosity of 13 at up to 30 percent of other regulated polymer
blends.
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
public display at the Dockets Management Branch (address above) for
public review and comment. Interested persons may, on or before
November 5, 1997 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: September 17, 1997.
Alan M. Rulis
Director, Office of Premarket Approval, Center for Food Safety and
Applied Nutrition.
[FR Doc. 97-26452 Filed 10-3-97; 8:45 am]
BILLING CODE 4160-01-F
