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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. 001119

Date:November 30, 2011
From:Biologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 1119 – Butanoic acid, 3-hydroxy-, (3R)-, polymer with 4-hydroxybutanoic acid (CAS Reg. No. 125495-90-1) and butanoic acid, 3-hydroxyl-, homopolymer (CAS Reg. No. 29435-48-1) as components of polymers used in articles that may contact food.
Notifier:Telles LLC
650 Suffolk Street, Suite 100
Loweel, MA 01854
To:Division of Food Contact Notifications (HFS-275)
Attention: Elizabeth Sánchez Furukawa, Ph.D., Ph.D.
Through: Annette M McCarthy, PhD, Lead Environmental Review Scientist

Attached is the Finding of No Significant Impact (FONSI) for FCN 1119. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated September 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. 1119), submitted by telles LLC, to provide for the safe use of butanoic acid, 3-hydroxy-, (3R)-, polymer with 4-hydroxybutanoic acid and butanoic acid, 3-hydroxyl-, homopolymer as components of polymers used in articles that may contact food as components of articles that may contact food.

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 September 20, 2011, in the notification submitted by the notifier, and other information known to the agency.

 

Prepared by __________________________________________Date: Movember 30, 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: November 30, 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