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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. 000060

Date: May 15, 2000

 

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

 

Subject: Premarket Notification FCN No. 000060 - Amines, Bis(Hydrogenated Rape-oil Alkyl) Methyl, N-oxides for use as an Antioxidant in Polypropylene Polymers

 

Notifier: GE Specialty Chemicals
1 Lexan Lane
Mt. Vernon, Indiana 47620

 

To: Division of Petition Control (HFS-215)
Attention: Julius Smith
Through: Team Leader, ERT (HFS-246)

 

 

Attached is the Finding of No Significant Impact (FONSI) for the above cited premarket notification. The FONSI and the notifier's Evironmental Assessment, dated April 18, 2000, should be made public when this notification becomes effective.

 

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.

 

 

 

 

Sylvia G. Matson

 

 

 



 



 

 

Finding of No Significant Impact

A premarket notification (FCN No. 000060), submitted by GE Specialty Chemicals Corporation, for the safe use of bis(hydrogenated rape-oil alkyl) methyl, N-oxides for use as an antioxidant in polypropylene for single as well as repeated use applications in contact with all food types.

 

 

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 is based on an environmental assessment dated April 18, 2000, prepared by the notifier.

 

 

 

Prepared by____________________________________________ Date: May 15, 2000
Sylvia G. Matson, Program Specialist
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: December 8, 2000
Buzz L. 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