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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001267

 

Date: April 1, 2013
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
 
Subject: FCN 1267 - 2-Propenoic acid, 2-methyl-, polymer with butyl 2-propenoate (CAS Reg. No 25035-82-9) for use as a pressure sensitive adhesive (PSA) or component of a PSA used as the food contact surface of labels and/or tapes applied to food, compliant with 21 175.125(a) or (b), under Conditions of use E through G.
Notifier: The Dow Chemical Company
 
To: Vivian Gilliam, Division of Food Contact Notifications (HFS-275)
Through: Annette M. McCarthy, Ph.D, Senior Science and Policy Staff____
 
 
 Attached is the Finding of No Significant Impact (FONSI) for FCN 1267. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated March 21, 2013, 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.
 
 
Talia A. Lindheimer
 
 
 
 
 
 
 
Attachment:         Finding of No Significant Impact
 


 

FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1267), submitted by The Dow Chemical Company, to provide for the safe use 2-Propenoic acid, 2-methyl-, polymer with butyl 2-propenoate (CAS Reg. No 25035-82-9), as a pressure sensitive adhesive (PSA) or component of a PSA used as the food contact surface of labels and/or tapes applied to food, compliant with 21 CFR 175.125 (a) or (b), under Conditions of Use E through G.
 
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 (EA), dated March 21, 2013, as summarized below.
 
The Food Contact Substance (FCS) will be used as or added to Pressure Sensitive Adhesives (PSAs) to be used with the foods listed in the PSA regulations found at 21 CFR 175.125. Types of PSAs include stickers and tapes that are applied directly to the surfaces of fruits and vegetables. The stickers are not intended to be used jointly with plastic wraps or food packaging papers. As such the FCS is expected to be disposed of via conventional trash disposal and primarily by incineration or sanitary landfills. The FCS is intended to either compete with PSAs already on the market or be used in conjunction with the previously authorized PSAs. No increase in the overall use of PSAs is expected as a result of the authorization of the FCS.
 
 When properly disposed into landfills operating in compliance with EPA regulations in 40 CFR Part 258 governing landfills, significant releases of the FCS to the environment would not be expected.   Furthermore, according to confidential market volume information as provided in Attachment 10 to the EA, the disposal of the FCS will not significantly alter emissions from municipal solid waste combustors or threaten a violation of 40 CFR Part 60, which regulate MSW combustion units.   As minimal release is expected, no significant environmental impacts are expected as a result of the proposed action. 
 
 
Prepared by     __________________________________________Date: April 1, 2013
Talia A. Lindheimer
Biologist
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
Approved by   __________________________________________Date: April 1, 2013
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