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U.S. Department of Health and Human Services

Food

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Environmental Decision Memo for Food Contact Notification No. 000101

Date: September 18, 2000

 

From: Chemist, Environmental Review Team (ERT)
Division of Product Manufacture and Use (HFS-246)

 

Subject: Premarket Notification FCN No.000101 - Perfluoro-carbon Cured Elastomers Used in Repeat Use Food-Processing Equipment

 

Notifier: DuPont Dow Elastomers L.L.C.
Wilmington, DE 19809

 

 

To: Division of Petition Control (HFS-215)
Attention: Andrew
Through: Team Leader, ERT

 

 

Attached is the Finding of No Significant Impact (FONSI) that we have prepared for the above cited PMN submission. When this notification becomes effective, the FONSI and the notifier's Environmental Assessment (Attachment VI) may be made available to the public. Attachment VII, which contains confidential environmental information, should remain confidential. Please let us know if there is any change in the identity or use of the food contact substance that would be inconsistent with the identity and use described in the FONSI.

 

 

 

John L. Dennison

 

 



 



 

 

Finding of No Significant Impact

A Premarket Notification (FCN No. 000101), submitted by DuPont Dow Elastomers L.L.C., to provide for perfluorocarbon cured elastomers produced by polymerizing perfluoro(methyl vinyl ether) with tetrafluoroethylene and perfluoro(8-cyano-5-methyl-3,6-dioxa-1-octene), followed by curing with trimethylallyl isocyanurate and/or triallyl isocyanurate, and with 2,5-dimethyl-2,5-di(t-butylperoxy) hexane used in the fabrication of articles intended for repeated use in contact with food.

 

 

The Environmental Review Team has determined that allowing this notification to become effective will not significantly affect the quality of the human environment and therefore will not require the preparation of an environmental impact statement. This finding was based on an environmental assessment, dated August 18, 2000, prepared by the notifier.

 

 

 

Prepared by: _________________________________________ Date: September 18, 2000
John L. Dennison, Chemist
Environmental Review Team
Division of Product Manufacture and Use
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration

 

 

 

Approved by: ________________________________________ Date: September 18, 2000
Buzz Hoffmann, Ph.D.,Team Leader
Environmental Review Team
Division of Product Manufacture and Use
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration