[Federal Register Volume 61, Number 167 (Tuesday, August 27, 1996)]
[Notices]
[Pages 44067-44068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-21845]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96F-0293]
Zeneca Inc.; 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
Zeneca Inc., has filed a petition proposing that the food additive
regulations be amended to provide for the safe use of 2-methyl-4,5-
trimethylene-4-isothiazolin-3-one as a preservative for paper and
paperboard coatings used in contact with food.
DATES: Written comments on the petitioner's environmental assessment by
September 26, 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.
[[Page 44068]]
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 6B4516) has been filed by Zeneca Inc.,
Foulkstone 1405, 2d, 1800 Concord Pike, Wilmington, DE 19850-5457. The
petition proposes to amend the food additive regulations in
Sec. 176.170 Components of paper and paperboard in contact with aqueous
and fatty foods (21 CFR 176.170) to provide for the safe use of 2-
methyl-4,5-trimethylene-4-isothiazolin-3-one as a preservative for
paper and paperboard coatings used 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
public display at the Dockets Management Branch (address above) for
public review and comment. Interested persons may, on or before
September 26, 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: August 8, 1996.
Alan M. Rulis,
Director, Office of Premarket Approval, Center for Food Safety and
Applied Nutrition.
[FR Doc. 96-21845 Filed 8-26-96; 8:45 am]
BILLING CODE 4160-01-F
