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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. 000034

Date: March 31, 2000

 

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

 

Subject: Premarket Notification - FCN No. 000034 - Nylon 6/12 Copolymer Resins for Use in Laminate Films that May Contact Food

 

Notifier: UBE Industries, Ltd., Japan
c/o Center for Regulatory Services
2347 Paddock Lane
Reston, Virginia 20191

 

To: Division of Petition Control (HFS-215)
Attention: Vivian Gilliam
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 should be made public when this notification becomes effective:

1. The FONSI.

2. The revised EA from FAP 8B4569, dated September 20, 1999. Please note that we have made several editorial corrections to the EA.

 

 

 

Hardy J. Chou, Ph.D.

 

 



 



 

 

Finding of No Significant Impact

A Premarket Notification (FCN 000034), submitted by UBE Industries, Ltd., to provide for the safe use of Nylon 6/12 copolymer resins manufactured using at least 80 weight percent epsilon-caprolactam and no more than 20 weight omega-aminododecanoic acid as a component of articles intended for 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 is based on information submitted by the petitioner in an environmental assessment.

 

This action was originally requested by UBE Industries, Ltd. in Food Additive Petition (FAP) 8B4569, as announced in the Federal Register on May 11, 1998 (63 FR, 25864). The food contact use requested in FCN No. 000034 is identical to the food contact use requested in FAP 8B4569. Therefore, the information provided in the environmental assessment for FAP 8B4569 is applicable to this notification.

 

 

 

Prepared by: ______________________________________ Date: March 31, 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: March 31, 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