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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. 001085

Date:May 4, 2011
From:Biologist, Regulatory Team B, Division of Biotechnology and GRAS Notice Review,
Office of Food Additive Safety (HFS-255)
Subject:FCN No. FCN No. 1085– Hexanedioic acid, polymer with 12-aminododecanoic acid, hexahydro-2H-azepin-2-one, and 1,6-hexanediamine as a component of multi-layer laminate food-contact articles used in contact with all types of food.
Notifier:UBE America, Inc.
28345 Beck Road, Suite 104
Wixom, MI 48393
To:Division of Food Contact Notifications (HFS-275)
Attention: Thomas C. Zebovitz, Ph.D.
Through: Annette M. McCarthy, Ph.D., Lead Environmental Review Scientist

Attached is the Finding of No Significant Impact (FONSI) for FCN 1085. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated March, 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. 1085), submitted by UBE America, Inc, to provide for the safe use of hexanedioic acid, polymer with 12-aminododecanoic acid, hexahydro-2H-azepin-2-one, and 1,6-hexanediamine as a component of multi-layer laminate food-contact articles used in contact with all types of 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, including an environmental assessment, dated March, 2011, in the notification submitted by the notifier, and other information known to the agency.

 

Prepared by __________________________________________Date: May 4, 2011
Hoshing W. Chang, Ph.D.
Regulatory Team B
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: May 4, 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