Environmental Decision Memo for Food Contact Notification No. 001260

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: March 18, 2013

From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)

Subject: FCN No. 1260 – Ethene, polymer with 1,2,3,4,4a,5,8,8a-octahydro-1,4:5,8-dimethanonaphthalene for use in food-contact articles contacting all food types under Conditions of Use A through H.

Notifier: Mitusi Chemicals, Inc.

To: Vivian Gilliam, 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 1260. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated March 1, 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


A food-contact notification (FCN No. 1260), submitted by Mitsui Chemicals, Inc., to provide for the safe use of ethene, polymer with 1,2,3,4,4a,5,8,8a-octahydro-1,4:5,8-dimethanonaphthalene in food-contact articles contacting all food types 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 March 1, 2013 as summarized below.

The FCS is not among the six resins which carry a Society of Plastics Industry (SPI) Resin Identification Code (RIC) of 1 through 6, indicating readily recyclable items. Those six resins are polyethyleneterephthalate (PETE, RIC 1), high-density polyethylene (HDPE, RIC 2), polyvinyl chloride (PVC or vinyl, RIC 3), low-density polyethylene (LDPE, RIC 4), polypropylene (PP, RIC 5), and polystyrene (PS, RIC 6). Thus, in order to prevent inadvertent recycling, items manufactured from the FCS will be designated with the RIC 7 for “Other.”

According to waste disposal statistics from EPA’s 2010 Municipal Solid Waste (MSW) Report,[1] of the total 249.9 million tons of municipal solid waste (MSW) generated in 2010, 135.7 million tons were land disposed, 29.3 million tons combusted, and 85.0 million tons recovered (a combination of waste recovered for recycling and for composting). Articles manufactured with the FCS are not expected to be recovered for recycling, thus, the disposal pattern is calculated based on only the quantities of MSW that are land disposed or combusted. On this basis, it is estimated that 18% of food packaging materials containing the FCS will be combusted annually. This amount is calculated as follows: 29.3 million tons combusted ÷ (29.3 million tons combusted + 135.7 million tons land disposed) = 18% combusted. The remaining 82% will be land-disposed.

Therefore, due to existing regulations governing landfills and combustion units, no significant environmental impacts are expected from the use and disposal of items manufactured from the FCS.

Prepared by     __________________________________________Date: March 18, 2013

Leah D. Proffitt
Office of Food Additive Safety 
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by   __________________________________________Date: March 18, 2013

Annette M. McCarthy, Ph.D.Senior Science and Policy Staff
Office of Food Additive Safety
Center for Food Safety and Applied NutritionFood 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.

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