[Federal Register Volume 63, Number 127 (Thursday, July 2, 1998)]
[Notices]
[Page 36246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17548]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 92F-0443]


Dow Corning Corp.; Filing of Food Additive Petition; Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is amending the filing 
notice for a food additive petition filed by Dow Corning Corp. to 
indicate that the petitioner has also proposed that the food additive 
regulations be amended to provide for the safe use of 
tetramethyltetravinylcyclotetrasiloxane as an optional polymerization 
inhibitor in the manufacture of dimethylpolysiloxane coatings produced 
by cross-linking a vinyl-containing dimethylpolysiloxane with 
methylhydrogen-containing polysiloxane and dimethylmethylhydrogen 
polysiloxane polymers using a platinum catalyst.

FOR FURTHER INFORMATION CONTACT: Julius Smith, Center for Food Safety 
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3091.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of February 12, 1993 (58 FR 8290), FDA announced that a 
petition (FAP 3B4346) had been filed by Dow Corning Corp., P.O. Box 
994, Midland, MI 48686-0994, proposing to amend Sec. 175.300 Resinous 
and polymeric coatings (21 CFR 175.300), Sec. 175.320 Resinous and 
polymeric coatings for polyolefin films (21 CFR 175.320), and 
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 
dimethylpolysiloxane coatings produced by cross-linking a vinyl-
containing dimethylpolysiloxane with methylhydrogen-containing 
polysiloxane and dimethylmethylhydrogen polysiloxane polymers using a 
platinum catalyst. The petition also proposed that the food additive 
regulations be amended to provide for the safe use of 3,5-dimethyl-1-
hexyne-3-ol, 1-ethynylcyclohexene, bis(methoxymethyl)ethyl maleate and 
methylvinyl cyclosiloxane as optional polymerization inhibitors. 
Additionally, the petition proposed that the regulations be amended to 
provide for the safe use of 5-chloro-2-methyl-4-isothiazolin-3-one and 
2-methyl-4-isothiazolin-3-one mixture, optionally containing magnesium 
nitrate, as an antimicrobial agent for emulsion-based silicone coating 
formulations.
    Subsequent to publication of the filing notice, the petitioner 
amended the petition to request the use of 
tetramethyltetravinylcyclotetrasiloxane as an optional polymerization 
inhibitor in the manufacture of dimethylpolysiloxane coatings produced 
by cross-linking a vinyl-containing dimethylpolysiloxane with 
methylhydrogen-containing polysiloxane and dimethylmethylhydrogen 
polysiloxane polymers using a platinum catalyst.
    Therefore, FDA is amending the filing notice of February 12, 1993, 
to indicate that the petitioner requests that the food additive 
regulations be amended to provide for the safe use of 
tetramethyltetravinylcyclotetrasiloxane as an optional polymerization 
inhibitor in the manufacture of dimethylpolysiloxane coatings produced 
by cross-linking a vinyl-containing dimethylpolysiloxane with 
methylhydrogen-containing polysiloxane and dimethylmethylhydrogen 
polysiloxane polymers using a platinum catalyst.
    The agency has determined under 21 CFR 25.32(i) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

    Dated: June 11, 1998.
Laura M. Tarantino,
Acting Director, Office of Premarket Approval, Center for Food Safety 
and Applied Nutrition.
[FR Doc. 98-17548 Filed 7-1-98; 8:45 am]
BILLING CODE 4160-01-F