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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. 001115

Date:August 25, 2011
From:Biologist, Regulatory Team 2
Division of Biotechnology and GRAS Notice Review (HFS-255)
Subject:FCN No. 1115 – Carbonic dichloride, polymer with 4,4′-(1-methylethylidene)bis[phenol], 4-(1-methyl-1-phenylethyl) phenyl ester (polycarbonate resins) in all food-contact applications, except baby nursing bottles and liquid training cups.
Notifier:SABIC Innovative Plastics
9226 Dupont Rd
Washington, WV 26181
To:Division of Food Contact Notifications (HFS-275)
Attention: Vanee Komolprasert, Ph.D.
Through: Annette McCarthy, PhD, Senior Science and Policy Staff ERT

For the requested repeat-use applications, we have reviewed the claim of categorical exclusion for the above referenced notification and have concluded that categorical exclusion is warranted. The claim of categorical exclusion cites the section, 21 CFR 25.32 (j), under which the categorical exclusion is warranted, states compliance with the categorical exclusion criteria, and states that no extraordinary circumstances exist that require the submission of an environmental assessment.

For the remaining requested uses, attached is the Finding of No Significant Impact (FONSI) for FCN 1115. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated July 13, 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.

 

Leah D. Proffitt

 

Attachments:
Finding of No Significant Impact


Finding of No Significant Impact

A food-contact notification (FCN No. 1115), submitted by SABIC Innovative Plastics, to provide for the safe use of 1 Carbonic dichloride, polymer with 4,4′-(1-methylethylidene)bis[phenol], 4-(1-methyl-1-phenylethyl) phenyl ester (polycarbonate resins) in all food-contact applications, except baby nursing bottles and liquid training cups.

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 July 13, 2011, in the notification submitted by the notifier, and other information known to the agency.

 

Prepared by __________________________________________Date: August 25, 2011
Leah D. Proffitt
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: August 25, 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