[Federal Register Volume 60, Number 185 (Monday, September 25, 1995)]
[Notices]
[Pages 49414-49415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23596]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95F-0255]


GE Silicones; 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 GE 
Silicones has filed a petition proposing that the food additive 
regulations be amended to provide for the safe use of vinyl-containing 
siloxanes as a coating on paper and paperboard in contact with food and 
to provide for the safe use of 1-ethynyl-1-cyclohexanol as an optional 
inhibitor for the additive. It is also proposed that the regulations be 
amended to increase the level of platinum catalyst used in the 
manufacture of vinyl-containing siloxanes to 200 parts per million 
(ppm).

DATES: Written comments on the petitioner's environmental assessment by 
October 25, 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.

FURTHER INFORMATION CONTACT: Hortense S. Macon, Center for Food Safety 
and Applied Nutrition (HFS-216), Food and Drug Administration, 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 
petition (FAP 5B4475) has been filed by GE Silicones, c/o 700 13th St., 
NW., Washington, DC 20005. 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 vinyl-containing siloxanes as a component of coatings 
for paper and paperboard in contact with food and to provide for the 
safe use of 1-ethynyl-1-cyclohexanol as an optional inhibitor for the 
additive. It is also proposed that the regulations be amended to 
increase the level of platinum catalyst used in the manufacture of 
vinyl-containing siloxane to 200 ppm.
    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 

[[Page 49415]]
public display at the Dockets Management Branch (address above) for 
public review and comment. Interested persons may, on or before (insert 
date 30 days after date of publication in the Federal Register), 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 evidence supporting that finding 
will be published with the regulation in the Federal Register in 
accordance with 21 CFR 25.40(c).

    Dated: September 13, 1995.
Alan M. Rulis,
Acting Director, Office of Premarket Approval, Center for Food Safety 
and Applied Nutrition.
[FR Doc. 95-23596 Filed 9-22-95; 8:45 am]
BILLING CODE 4160-01-F