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U.S. Department of Health and Human Services


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Environmental Decision Memo for Food Contact Notification No. 001358

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: November 19, 2013

From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
Subject: FCN 1358 - Polyoxypropylene-polyoxyethylene condensate (CAS Reg. No. 9003-11-6, minimum molecular weight of 1700), as a component of adhesives used in contact with food. 
Notifier: The Dow Chemical Company
To: Elizabeth Furukawa, Ph.D, 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 1358. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated June 26, 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
File:    FCN No. 1358 


A food-contact notification (FCN No. 1358), submitted by The Dow Chemical Company, to provide for the safe use of polyoxypropylene-polyoxyethylene condensate (CAS Reg. No. 9003-11-6, minimum molecular weight of 1700), as a component of adhesives used in contact with food. 
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 June 26, 2013, as summarized below.
The Food Contact Substance (FCS) will be used as a reactant to produce urethane polymer adhesives, and additionally as a surfactant or blending aid of adhesives. There is no expected environmental release upon the use of the FCS to fabricate food-contact materials.  These adhesives are regulated under 21 CFR 175.105 and are intended for use with films and rigid containers. The FCS-containing adhesives will be used on food-contact articles that are not currently recovered for recycling to a significant extent, and therefore it is reasonable to expect that the FCS is expected to be disposed of via conventional trash disposal and primarily by incineration or sanitary landfills.  
When properly disposed into landfills operating in compliance with EPA regulations in 40 CFR Part 258, significant releases of the FCS to the environment are not expected.   Furthermore, market volume information provided in a confidential attachment to the EA supports that the combustion of the FCS in municipal waste combustors are not expected to threaten a violation of applicable emissions laws and regulations (40 CFR Part 60).  As minimal release is expected, no significant environmental impacts are expected.
In the event that an FCS-containing adhesive is used on rigid containers or bottles intended for recycling, we expect it to be used similarly to current products. The FCS is intended to compete with, and in some degree replace, adhesives that are already on the market. Therefore, it is reasonable to expect there will be no significant impact on the current recycling program or an increase in the overall use of adhesives as a result of the authorization of the FCS.
Prepared by     __________________________________________Date: November 19, 2013
Talia A. Lindheimer
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Approved by   __________________________________________Date: November 19, 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