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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. 001051

Date: February 14, 2010
From: Biologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject: FCN No. 1051 – Ethylene/propylene copolymers as the basic polymer used in the production of articles intended to contact food.
Notifier: LyondellBasell Industries
3801 West Chester Pike
Newtown Square, Pennsylvania 19073
To: Division of Food Contact Notifications (HFS-275)
Attention: Thomas C Zebovitz, Ph.D.
Through: William H Lamont, Acting Supervisor, ERT

The food-contact substance (FCS) is ethylene/propylene copolymers polymerized in the presence of propylene homopolymers, complying with 21 C.F.R. § 177.1520(c), Item 1.1, to produce an inseparable blend of the two polymers. The notifier submitted a claim of categorical exclusion under 21 CFR 25.32(j) for repeat-use applications. We have reviewed the claim of categorical exclusion and have concluded that categorical exclusion is warranted. The claim of categorical exclusion cites the section—21 CFR 25.32(j)—under which 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. Also, the notifier submitted an environmental assessment for the proposed single-use applications of the FCS. We have reviewed the environmental assessment, and we have prepared the attached Finding of No Significant Impact (FONSI) for FCN 1051. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated January 12, 2011, may be made available to the public. We shall 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.

 

Attachments:
Finding of No Significant Impact


Finding of No Significant Impact

A food contact notification (FCN No. 1051), submitted by LyondellBasell Industries, to provide for the safe use of ethylene/propylene copolymers polymerized in the presence of propylene homopolymers, complying with 21 C.F.R. § 177.1520(c), Item 1.1, to produce an inseparable blend of the two polymers as the basic polymer used in the production of articles intended to contact 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 submitted by the notifier, in an environmental assessment, dated January 12, 2011, separate confidential information attached to the notification, and other information known to the agency.

 

Prepared by __________________________________________Date: February 14, 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: February 14, 2011
William H. Lamont, Chemist
Acting Supervisor, Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration