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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001399

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: January 23, 2014
 
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
 
Subject: FCN No. 1399 – Ethylene-vinyl acetate-vinyl alcohol (EVOH) copolymers modified with up to 8 mol% 1,2-epoxypropane, as an internal, non food-contact layer separated from food by one or more layers having a suitable regulatory status for use in direct contact with food in single service and repeated-use food-contact articles both (1) as a stand-alone layer; or (2) at levels of up to 30% in blends with EVOH.
 
Notifier: Kuraray Company, Ltd.
 
To: Tom Zebovitz, Ph.D., Division of Food Contact Notifications (HFS-275)
Through: Mariellen Pfeil, Environmental Reviewer, Office of Food Additive Safety, HFS-255____
 
Attached is the Finding of No Significant Impact (FONSI) for FCN 1399. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated November 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.
 
Leah D. Proffitt
 
Attachment: Finding of No Significant Impact
File: FCN No. 1399
FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1399), submitted by Kuraray Co., Ltd., to provide for the safe use of ethylene-vinyl acetate-vinyl alcohol (EVOH) copolymers modified with up to 8 mol% 1,2-epoxypropane, as an internal, non food-contact layer separated from food by one or more layers having a suitable regulatory status for use in direct contact with food in single service and repeated-use food-contact articles both (1) as a stand-alone layer; or (2) at levels of up to 30% in blends with EVOH..
 
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 in an environmental assessment, dated November 26, 2013 as summarized below.
 
The FCS will be incorporated as a non food-contact layer in food-contact polymers already in use in the market. Articles made with the FCS are not expected to adversely impact recycling rates. The FCS possesses technical properties that make if useful for food-contact applications. Some of those properties include higher orientability, toughness and flexibility.
 
Introduction of the FCS into the environment is expected to occur via land disposal and waste combustion, with approximately 82% being landfilled and 18% incinerated, according to 2011 EPA figures referenced in the EA [1],[2]. Due to EPA’s regulations governing landfills at 40 CFR Part 258, only very small amounts of the FCS or its components are expected to enter the environment. Furthermore, no violations of federal, state or local emissions laws are expected as a result of disposal by permitted solid waste incineration facilities, due to regulations at 40 CFR Parts 60. There are no extraordinary circumstances surrounding manufacture, use, or disposal of the FCS.
 
Similarly, the replacement of other polymers by the FCS is not expected to adversely affect the use of energy and resources, as the manufacture and use of the FCS will consume comparable resources as those substances it is intended to replace. It is important to note that the FCS will not be used in conjunction with PET beverage bottles, in order not to interfere with recycling practices.
 
Prepared by       __________________________________________Date: January 23, 2014
Leah D. Proffitt
Biologist
Office of Food Additive Safety  
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
Approved by      __________________________________________Date: January 23, 2014
Robert I. Merker, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
[1] Municipal Solid Waste in the United States: 2011 Facts and Figures, EPA530-R-13-001, U.S. Environmental Protection Agency, www.epa.gov, May 2013
 
[2] The distribution of disposal patterns is re-calculated from the EPA report based on only the percent land disposed and combusted: % Combusted = 11.7% combusted ÷ (11.7% combusted + 54.3% land disposed) = 17.7% combusted. % Land-disposed = 54.3% land-disposed ÷ (11.7% combusted + 54.3% land disposed) = 82.3% land-disposed.