Food

Environmental Decision Memo for Food Contact Notification No. 001156

Return to inventory listing: Inventory of Environmental Impact Decisions for Food Contact Substance Notifications or the Inventory of Effective Food Contact Substance Notifications.

See also Environmental Decisions.


Date: February 29, 2012

From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)

To: Division of Food Contact Notifications (HFS-275)
Attention: Kenneth McAdams, Ph.D. 
Through: Annette M. McCarthy, Ph.D, Senior Science and Policy Staff____ 

Subject: FCN No. 1156 – 2-Propenoic acid, butyl ester, polymer with ethene as the basic polymer in the manufacture of single- and repeat-use food-contact articles having a maximum thickness of 210 µm. 

Notifier: LyondellBasell Industries 

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 single-use applications, attached is the Finding of No Significant Impact (FONSI) for FCN 1156. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated January 4, 2012, 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 

Attachment: Finding of No Significant Impact 


FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1156), submitted by LyondellBasell Industries to provide for the safe use of 2-Propenoic acid, butyl ester, polymer with ethene as the basic polymer in the manufacture of single-use food-contact articles having a maximum thickness of 210 µm. 

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 submitted by the notifier in an environmental assessment, dated January 4, 2012. 

Prepared by     __________________________________________Date: February 29, 2012

Leah D. Proffitt

Biologist
Office of Food Additive Safety 
Center for Food Safety and Applied Nutrition
Food and Drug Administration  

Approved by   __________________________________________Date: February 29, 2012

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

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