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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. 001104

Date:June 28, 2011
From:Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety (HFS-255)
Subject:FCN No. 1104 – Bicyclo[2.2.1]hept-2-ene, polymer with ethane as a basic polymer in the production of articles that may contact food to provide a moisture barrier, clarity, and elastomeric properties.
Notifier:Topas Advanced Polymers, Inc.
8040 Dixie Highway
Florence, KY 41042
To:Division of Food Contact Notifications (HFS-275)
Attention: Helen Lee, Ph.D.
Through: Annette M McCarthy, Ph.D., Lead Environmental Review Scientist

Attached is the Finding of No Significant Impact (FONSI) for FCN 1104. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated May 20, 2011, may be made available to the public. We will post digital transcriptions of the FONSI and the environmental assessment on the agency's public website.

Please let us know if there is any change in the identity or use of the food-contact substance.

 

Hoshing W. Chang, Ph.D.

 

Attachment:
Finding of No Significant Impact


Finding of No Significant Impact

A food-contact notification (FCN No. 1104), submitted by Topas Advanced Polymers, Inc., to provide for the safe use of of Bicyclo[2.2.1]hept-2-ene, polymer with ethane as a basic polymer in the production of articles that may contact food to provide a moisture barrier, clarity, and elastomeric properties.

The Office of Food Additive Safety 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, including an environmental assessment, dated May 20, 2011, in the notification submitted by the notifier, and other information known to the agency.

 

Prepared by __________________________________________Date: June 28, 2011
Hoshing W. Chang, Ph.D.
Regulatory Team 2
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: June 28, 2011
Annette M. McCarthy, Ph.D.
Lead Environmental Review Scientist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration