[Federal Register Volume 63, Number 247 (Thursday, December 24, 1998)]
[Notices]
[Pages 71294-71295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-34112]


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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 1,2-dibromo-2,4-
dicyanobutane as an antimicrobial agent 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. The petition proposed 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

[[Page 71295]]

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, in a notice published in the Federal Register of July 2, 
1998 (63 FR 36246), FDA amended the filing notice of February 12, 1993, 
to indicate that the petitioner requests that the food additive 
regulations be amended to provide for the additional 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.
    Additionally, subsequent to publication of the filing notice of 
July 2, 1998, the petitioner amended the petition to request the use of 
1,2-dibromo-2,4-dicyanobutane as an antimicrobial agent 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 July 2, 1998, to 
indicate that the petitioner requests that the food additive 
regulations be amended to provide for the safe use of 1,2-dibromo-2,4-
dicyanobutane as an antimicrobial agent 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: December 11, 1998.
Eugene C. Coleman,
Acting Director, Office of Premarket Approval, Center for Food Safety 
and Applied Nutrition.
[FR Doc. 98-34112 Filed 12-23-98; 8:45 am]
BILLING CODE 4160-01-F