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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001293

 

Date: June 19, 2013
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
 
Subject: FCN No. 1293 – Oxirane, methyl-, polymer with oxirane for use as a surface active agent in the manufacture of polymeric food-contact materials.
Notifier: Equistar Chemicals, L.P.
 
To: Kenneth McAdams, 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 1293. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated June 4, 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.
 
 
Leah D. Proffitt
 
 
 
 
 
 
 
Attachment:         Finding of No Significant Impact
 
           


 

FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1293), submitted by Equistar Chemicals, L.P., Inc., to provide for the safe use of oxirane, methyl-, polymer with oxirane as a surface active agent in the manufacture of polymeric food-contact materials.
 
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 June 4, 2013 as summarized below.
 
The FCS is intended to be used in a manner consistent with other similar polymeric materials. The FCS is expected to remain with food contact materials through use and disposal by the consumer. Therefore, the primary environmental concern is related to land disposal and combustion at permitted facilities, and recycling practices.
 
Example applications for the material include: (1) use as a dusting agent to coat resin pellets to prevent sticking; (2) use as a low shrink additive for unsaturated polyester-based fiberglass formulations used in repeated use applications; and (3) use as a binder for granulated carbon in water filters intended for repeated-use. Polymers applicable to (1) are not generally included in recycling programs and are, in fact, not typically recycled. The materials described in the second and third applications also are unlikely to be collected for recycling to any appreciable extent. Thus, the primary route of environmental introduction is disposal to landfills or via combustion.
 
To assess the potential impacts of the disposal, waste disposal statistics from EPA’s 2011 Municipal Solid Waste (MSW) Report have been consulted.[1] According to this report, of the total of 249.8 million tons of municipal solid waste (MSW) generated in 2010, 135.7 million tons (54.3%) were land disposed, 29.3 million tons (11.7%) combusted, 64.8 million tons (25.9%) recovered for recycling, and 20.2 million tons (8.75%) composted. However, since articles manufactured with the FCS will primarily be land disposed or combusted, the disposal patterns have been adjusted as follows: 17.7 % of food packaging materials containing the FCS will be combusted annually. This amount is calculated as follows: 11.7 % combusted ÷ (11.7 % combusted + 54.3 % land disposed) = 17.7 % combusted. The remaining 82.3 % will be land disposed. Due to EPA regulations in 40 CFR part 258 governing landfills, releases to the environment from land disposal are not expected. Similarly, given the confidential market volume projections, combustion is not expected to alter emissions from permitted MSW incineration facilities. Thus, we do not expect significant environmental impacts from the use and disposal of the FCS.
 
 
 
 
 
Prepared by     __________________________________________Date: June 19, 2013
Leah D. Proffitt
Biologist
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
 
 
Approved by   __________________________________________Date: June 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



[1]U.S. Environmental Protection Agency. Municipal Solid Waste Generation, Recycling, and Disposal in the United States: Facts and Figures for 2010. EPA-530-F-011-005, November 2011, Washington, DC.