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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001265

 

Date: March 27, 2013
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
 
Subject: FCN No. 1265 – Polymer of dimethyl terephthalate, 1,4-cyclohexanedimethanol, and 2,2,4,4-tetramethyl-1,3-cyclobutanediol containing repeat units consisting of terephthalate esters of 2,2,4,4-tetramethyl-1,3-cyclobutanediol at up to 40 mole percent (expressed as mole percent of the glycol component of the finished copolyesters) and 1,4- cyclohexanedimethanol at no less than 60 mole percent, and, optionally, ≤ 0.5 percent (by weight of the finished resin) trimellitic anhydride as a branching agent, for use in single-use food applications in contact with all foods except V and IX under Conditions of Use C through H.
Notifier: Eastman Chemical Co., Inc.
 
To: Paul Honigfort, 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 1265. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated January 23, 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. 1265), submitted by Eastman Chemical Co., Inc., to provide for the safe use of polymer of dimethyl terephthalate, 1,4-cyclohexanedimethanol, and 2,2,4,4-tetramethyl-1,3-cyclobutanediol containing repeat units consisting of terephthalate esters of 2,2,4,4-tetramethyl-1,3-cyclobutanediol at up to 40 mole percent (expressed as mole percent of the glycol component of the finished copolyesters) and 1,4- cyclohexanedimethanol at no less than 60 mole percent, and, optionally, ≤ 0.5 percent (by weight of the finished resin) trimellitic anhydride as a branching agent, for use in single-use food applications in contact with all foods except V and IX under Conditions of Use C through H.
 
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 23, 2013 as summarized below.
 
The copolymer is intended to be used in place of other polymers currently in use, such as polycarbonate, polyproplylene and PET, for applications other than single-use soda and water bottles, which are widely recycled. Articles made from the FCS will bear the identification code No. 07, “Other,” and are not expected to be used in the manufacture of soda or water bottles. Thus, articles made with the copolymer are not expected to inadvertently enter the recycling stream nor adversely impact recycling rates.
 
Products containing the FCS are expected to replace and be disposed at a rate equivalent to products with similar use profiles. Disposal of products containing the FCS is expected to be the primary route of introduction into the environment. 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. 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: March 27, 2013
Leah D. Proffitt
Biologist
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
 
 
Approved by   __________________________________________Date: March 27, 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.