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Environmental Decision Memo and EA Revision Sheet for Food Contact Notification No. 1717

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 2, 2017

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

Subject: Food Contact Notification (FCN) 1717 – Ethene, polymer with 1-hexene and 1-propene (CAS Reg. No. 25895-46-9).

Notifier: Japan Polyethylene Corporation

To: Elizabeth Furukawa, Ph.D., Division of Food Contact Notifications (HFS-275)
Through: Suzanne Hill, Environmental Team Supervisor, Office of Food Additive Safety, HFS-255

Attached is the Finding of No Significant Impact (FONSI) for food-contact notification (FCN) 1717.

After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated December 13, 2016, and an EA revision sheet, dated March 2, 2017 may be made available to the public. We will post digital transcriptions of the FONSI, EA revision sheet and the EA 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 (FCS).

Mariellen Pfeil

Attachment: Finding of No Significant Impact; EA Revision Sheet


A food-contact notification (FCN No. 1717), submitted by Center for Regulatory Services, Inc. on behalf of Japan Polyethylene Corporation, to provide for the safe use of Ethene, polymer with 1-hexene and 1-propene (CAS Reg. No. 25895-46-9) as a component of polyolefin film, except for use in contact with infant formula and human milk. The FCS will consist of a minimum of 75 weight % ethene, up to 15 weight% propene, and 15 weight % hexene, with the combined wt % of propene and hexene not exceeding 25 wt %. The finished polyolefin film will consist of no more than 80 weight % of the FCS. The maximum thickness of the polyolefin film containing the FCS is 100 µm. The FCS may be used in contact with all foods under FDA 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, an environmental impact statement will not be prepared. This finding is based on information submitted by the notifier in an environmental assessment (EA), dated December 13, 2016. The EA is incorporated by reference in this Finding of No Significant Impact, and is briefly summarized below. The EA was prepared in accordance with 21 CFR 25.40.

The FCS is intended to improve the heat seal strength at low heat-seal temperatures. The FCS will be manufactured into finished food packaging materials or films. These final materials will be widely distributed across the country, and therefore disposed of nationwide.

Post-consumer disposal of the articles which contain the FCS will be to landfills or municipal solid waste (MSW) combustors complying with 40 CFR Parts 258 and 60, respectively. Materials containing the FCS are not expected to be recycled. No significant effect on the concentrations of and exposures to any substances in air, water or soil are anticipated. Finished articles containing the FCS are expected to be of high molecular weight, and are not volatile or likely to leach. The FCS is comprised of carbon and hydrogen only so will not significantly alter the emissions from properly operating MSW combustion facilities, and incineration of the FCS will not cause municipal waste combustors to threaten a violation of applicable emissions laws and regulations at 40 CFR Parts 60, regulations for mandatory emissions reporting at 40 CFR 98, and/or relevant state and local laws. Based upon an analysis using market volume information provided in the confidential attachment to the EA there are no significant impacts with respect to greenhouse gas emissions resulting from incineration of materials containing the FCS. Thus, the use of the FCS as proposed is not reasonably expected to result in environmental impacts requiring mitigation measures.

The FCS is manufactured from raw materials that are already produced for various uses. It is intended to replace similar polyolefin materials currently used in food contact applications. Thus significant impacts to the use of energy and resources are not anticipated.

No potential adverse environmental effects are identified that would necessitate alternative actions to those proposed. The alternative of not approving the notified action would result in the continued use of the materials that the subject FCS would otherwise replace; such action would have no significant environmental impacts.

As evaluated in the EA, the use of the FCS as described in FCN 1717 will not significantly affect the human environment. Therefore, an environmental impact statement will not be prepared.

Prepared by __________________________________________Date: digitally signed 03-02-2017
Mariellen Pfeil
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________ Date: digitally signed 03-02-2017
Suzanne Hill
Environmental Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

U.S. Food and Drug Administration
Revision Sheet for the December 13, 2016 EA for FCN 1717

Dated: February 13, 2017

U.S. Food and Drug Administration (FDA) in its review of the December 13, 2016 Environmental Assessment (EA) for food contact notification (FCN) 1717 concluded that the action would not constitute a significant impact. This revision, while not making any substantive changes to the EA, is issued to make a minor clarification that should be acknowledged. This revision does not impact our Finding of No Significant Impact (FONSI) and is as follows:

On pages two and four of the EA the notifier cites U.S. EPA report #EPA-530-R-15-002 (Citation: Advancing Sustainable Materials Management: Facts and Figures 2013, Assessing Trends in Material Generation, Recycling and Disposal in the United States, EPA-530-R-15-002, June 2015, available at http://www.epa.gov/epawaste/nonhaz/municipal/pubs/2013_advncng_smm_rpt.pdf). This reference is used to describe the disposal distribution pattern of articles manufactured with the FCS and provide assumptions used in the analysis of greenhouse gas emissions.

EPA has issued more recent statistics regarding disposal patterns for municipal solid waste (see, U.S. EPA, Advancing Sustainable Materials Management: 2014 Tables and Figures. December 2016. Available at https://www.epa.gov/sites/production/files/2016-11/documents/2014_smm_tablesfigures_508.pdf). Upon review of the EPA 2014 report, we find that the disposal pattern of the FCS as described in the EA is still accurately described, i.e. the new statistics do not impact the analysis presented in the December 13, 2016 EA.

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