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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001068

Date:March 15, 2010
From:Biologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 1068– Fatty acids, coco, sesquiesters with polyethylene glycol as antistatic agent for use in the manufacture of Nylon 6 film.
Notifier:Unitika Ltd.
31-3 Uji-Hinojiri
Uji-shi, Ky 611-0021, Japan95358
To:Division of Food Contact Notifications (HFS-275)
Attention: Donna J. Robie, Ph.D.
Through: Annette M. McCarthy, Ph.D.

Attached is the Finding of No Significant Impact (FONSI) for FCN 1068. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated March 8, 2011, and the supplement to the environmental record 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
Supplement to the Environmental Record for Food Contact Notification No. 1068


Finding of No Significant Impact

A food-contact notification (FCN No. 1068), submitted by Unitika Ltd., to provide for the safe use of fatty acids, coco, sesquiesters with polyethylene glycol as antistatic agent for use in the manufacture of Nylon 6 film.

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 8, 2011, and our supplement to the environmental record for FCN 1068, in the notification submitted by the notifier, and other information known to the agency.

 

Prepared by __________________________________________Date: March 15, 2011
Hoshing W. Chang, Ph.D.
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: March 15, 2011
Annette M. McCarthy, Ph.D.
Senior Science and Policy Staff
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration


Supplement to the Environmental Record for Food Contact Notification No. 1068

This document incorporates by reference the notifier's environmental assessment (EA), dated March 8, 2011.

The purpose of this supplement is to ensure the accuracy and completeness of the environmental record and to assist the public in understanding the agency’s basis for preparing a finding of no significant impact (FONSI).

Item 7 contains a reference to an MSDS as the source of to the BOD5 value. The document referenced is “Material Safety Data Sheet (MSDS) for fatty acids, coco, sesquiesters with polyethylene glycol” listed under item 14 “References” in the EA.

 

Prepared by __________________________________________Date: March 15, 2011
Hoshing W. Chang, Ph.D.
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration