[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