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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. 000032

Date: March 9, 2000

 

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

 

Subject: Premarket Notification FCN No. 000032 for use of alpha-(dinonylphenyl)-omega-hydroxypoly(oxy-1,2-ethanediyl) as a component in coatings for paper and paperboard

 

Notifier: BASF Corporation
Charlotte Technical Center
Charlotte, NC 28273

 

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

 

 

Attached is the Finding of No Significant Impact (FONSI) that we have prepared for the above cited PMN submission. The Environmental Assessment (EA) dated April 30, 1999 was prepared by the notifier in accordance with previous 21 CFR 25.31 a(b)(1). When this notification becomes effective, the EA and FONSI should be made available to the public. 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. 000032), submitted by BASF Corporation, to provide for the safe use of alpha-(dinonylphenyl)-omega-hydroxypoly(oxy-1,2-ethanediyl), containing 21 moles of ethylene oxide per mole of dinonylphenyl as a component in coatings for paper and paperboard at levels not to exceed 0.05% by weight of finished coatings.

 

 

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 action was originally requested in a threshold of regulation exemption request (TOR No. 210). The food contact use requested in the notification is identical to the use requested in TOR No. 210. Therefore, the information presented in the environmental assessment for TOR No. 210 is applicable to this notification, and this Finding of No Significant Impact is based on that information.

 

 

 

Prepared by: ___________________________________________ Date: March 9, 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: March 9, 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