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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. 000068

Date: July 21, 2000

 

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

 

Subject: Premarket Notification- FCN 000068 - Propylene-butene-1Copolymers for Use in Blends with Polypropylene and High-Propylene Olefin Copolymers Intended to Contact Food

 

Notifier: Mitsui Chemical, Inc., Japan
c/o Keller and Heckman LLP
Washington, DC 20001

 

To: Division of Petition Control (HFS-215)
Attention: Edward Machuga, Ph.D.
Through: Team Leader, ERT

 

 

Attached to this memorandum is the Finding of No Significant Impact (FONSI) for the above cited premarket notification. The following environmental documents may be made public when this notification becomes effective:

 

1. This FONSI.

 

2. The revised EA from FAP 8B4590 dated January 12, 2000. Please note that the notifier transmitted a revised page 12, with the July 14, 2000, letter. The revised page should replace page 12 of the EA dated January 12, 2000. This page was modified to remove information regarding the market and production volumes, which was placed in Confidential Attachment 1. Attachment 1 should not 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.

 

 

Hardy J. Chou, Ph.D.

 

 



 



 

 

Finding of No Significant Impact

A Premarket Notification (FCN No. 000068), submitted by Mitsui Chemical, Inc. for the safe use of propylene-butene-1 copolymers for use in blends with polypropylene and high-propylene olefin copolymers intended for 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 is based on a revised environmental assessment prepared by Mitsui Chemicals, Inc., for Food Additive Petition (FAP) 8B4590.

 

This action was originally requested by Mitsui Chemicals, Inc., in FAP 8B4590, as announced in the Federal Register on May 7, 1998 (63 FR 25213). The food contact use requested in FCN 000068 is identical to the food contact use requested in FAP 8B4590. Therefore, the information provided in the revised EA for FAP 8B4590 is applicable to this notification

 

 

 

Prepared by: ____________________________________________ Date: July 21, 2000
Hardy J. Chou, Ph.D., 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: July 21, 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