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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001234

 

November 2, 2012
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
Through: Annette M. McCarthy, Ph.D, Senior Science and Policy Staff____
 
To: Division of Food Contact Notifications (HFS-275)
Attention: Hui Chen Chang, Ph.D.
 
Subject: FCN No. 1234 – Copolymers and polymers made from the reaction of dimethyl terephthalate or terephthalic acid with a mixture containing 0 to 99 mole percent of ethylene glycol and 100 to 1 mole percent of 1,4-cyclohexanedimethanol (70 percent trans isomer, 30 percent cis isomer) as articles or components of articles intended for contact with food.
 
Notifier: Eastman Chemical Company
 
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 remaining requested uses, attached is the Finding of No Significant Impact (FONSI) for FCN 1234. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated September 21, 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. 1234), submitted by Eastman Chemical Company, to provide for the safe use of copolymers and polymers made from the reaction of dimethyl terephthalate or terephthalic acid with a mixture containing 0 to 99 mole percent of ethylene glycol and 100 to 1 mole percent of 1,4-cyclohexanedimethanol (70 percent trans isomer, 30 percent cis isomer) as articles or components of articles intended for 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, dated September 21, 2012 as summarized below.
 
No significant environmental impacts are expected from disposal at permitted municipal solid waste (MSW) landfills, given EPA’s regulations in 40 C.F.R. Part 258. These regulations require new MSW landfills and lateral expansions of existing units to have composite liners and leachate collection systems to prevent leachate from entering ground and surface water, and to have ground-water monitoring systems. Owners and operators of landfills constructed before October 9, 1993, are not required to retrofit their facilities with liners and leachate collections systems, but must monitor groundwater.
 
Furthermore, based on confidential projected production amounts for 2017, use of the FCS is not anticipated to have a significant effect on total amounts of land disposed PET or PET combusted for energy recovery.
 


 

 
 
Prepared by     __________________________________________Date: November 2, 2012
Leah D. Proffitt
Biologist
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
 
 
Approved by   __________________________________________Date: November 2, 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