[Federal Register Volume 60, Number 133 (Wednesday, July 12, 1995)]
[Notices]
[Pages 35914-35915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17093]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95F-0150]


Hoechst Aktiengesellschaft; 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 
Hoechst Aktiengesellschaft has filed a petition proposing that the food 
additive regulations be amended to provide for the safe use of 
polymeric 2,2,4,4-tetramethyl-7-oxa-3,20-diaza-20-(2,3-epoxypropyl)-
dispiro-[5.1.11.2]-heneicosane-21-one as an antioxidant and/or 
stabilizer for polyolefins intended for contact with food.

DATES: Written comments on the petitioner's environmental assessment by 
August 11, 1995.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Daniel N. Harrison, Center for Food 
Safety and Applied Nutrition (HFS-216), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204-0002, 202-418-3080.

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 5B4461) has been filed by Hoechst 
Aktiengesellschaft, c/o 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 safe use of polymeric 2,2,4,4-tetramethyl-
7-oxa-3,20-diaza-20-(2,3-epoxypropyl)-dispiro-[5.1.11.2]-heneicosane-
21-one (CAS Reg. No. 78301-43-6) as an antioxidant and/or stabilizer 
for polyolefins intended for 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 August 
11, 1995, 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 

[[Page 35915]]
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 23, 1995.
 Alan M. Rulis,
 Acting Director, Office of Premarket Approval, Center for Food Safety 
and Applied Nutrition.
[FR Doc. 95-17093 Filed 7-11-95; 8:45 am]
BILLING CODE 4160-01-F