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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001374

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 14, 2013
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
 
Subject: FCN No. 1374 – Phosphonic acid, [[3,5-bis(1, 1-dimethylethyl)-4-hydroxyphenyl]methyl]-, diethyl ester, as an antioxidant/stabilizer for all polyester polymers at levels not to exceed 1100 ppm (0.11%), and for contact with all food types and under conditions of use A through H.
Notifier: Toyobo Co., Ltd.
 
To: Kelly Randolph, Ph.D., DVM, 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 1374. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated September 3, 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. 1374), submitted by Toyobo Co., Ltd., to provide for the safe use of phosphonic acid, [[3,5-bis( 1, 1-dimethylethyl)-4-hydroxyphenyl]methyl]-, diethyl ester, as an antioxidant/stabilizer for all polyester polymers at levels not to exceed 1100 ppm (0.11%), and for contact with all food types and under conditions of use A 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 September 3, 2013 as summarized below.
 
The FCS will be incorporated as an antioxidant/stabilizer in food-contact polymers already in use in the market. Articles made with the FCS are not expected to 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. Recycling and disposal of products containing the FCS are expected to be the primary routes of introduction into the environment. To assess the potential impacts of the disposal, waste disposal statistics from EPA’s 2010 Municipal Solid Waste (MSW) Report have been consulted.[1] According to this report, of the total of 250 million tons of municipal solid waste (MSW) generated in 2010, 135 million (54.2%) were land disposed, 29 million (11.7%) combusted, 65 million (26%) recovered for recycling, and 20 million tons (8%) composted. Due to EPA regulations in 40 CFR part 258 governing MSW landfills, and in 40 CFR Part 60 governing municipal waste combustion (MWC) units, releases to the environment from land disposal and combustion are not expected. Thus, we do not expect significant environmental impacts from the use and disposal of the FCS.
 
 Prepared by     __________________________________________Date: November 14, 2013
Leah D. Proffitt
Biologist
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
 Approved by   __________________________________________Date: November 14, 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] Municipal Solid Waste Generation, Recycling, and Disposal in the United States: Facts and Figures for 2010. http://www.epa.gov/osw/nonhaz/municipal/pubs/msw_2010_rev_factsheet.pdf.