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.

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Date: February 10, 2017

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

Subject: Finding of No Significant Impact for Food Contact Notification (FCN) 1707 for 1,4-benzenedicarboxylic acid, polymer with 5-amino-1,3,3 trimethylcyclohexanemethanamine and hexahydro-2H-azepin-2-one in single- and repeat-use food-contact applications. (CAS Reg. No. 1105025-82-8).

To: Vivian Gilliam, Consumer Safety Officer, Division of Food Contact Notifications (HFS-275)
Through: Suzanne Hill, Environmental Supervisor, Office of Food Additive Safety, HFS-255

Attached is the Finding of No Significant Impact (FONSI) for FCN 1707 for use of 1,4-benzenedicarboxylic acid, polymer with 5-amino-1,3,3 trimethylcyclohexanemethanamine and hexahydro-2H-azepin-2-one in single- and repeat-use food-contact applications. (CAS Reg. No. 1105025-82-8)

After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated September 27, 2016, 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

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FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1707), submitted by DSM Engineering Plastics B.V., to provide for the safe use of 1,4-benzenedicarboxylic acid, polymer with 5-amino-1,3,3 trimethylcyclohexanemethanamine and hexahydro-2H-azepin-2-one in single- and repeat-use food-contact applications. (CAS Reg. No. 1105025-82-8).

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 prepared. This finding is based on information submitted by the notifier in an environmental assessment, dated September 27, 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 provides improved performance and productivity gains compared with conventional polyamides. Items containing the FCS will be disposed of to landfills or municipal solid waste (MSW) combustion facilities complying with 40 CFR Parts 258 and 60, respectively. The FCS will not significantly alter the emissions from properly operating MSW combustion facilities, and incineration of the FCS will not cause these facilities to threaten a violation of applicable emissions laws and regulations at 40 CFR Part 60 and/or relevant state and local laws. Market volume information provided in a confidential attachment to the EA demonstrates that the FCS will comprise a very small portion of MSW, as compared to overall MSW generated; this comparison uses U.S Environmental Protection Agency’s (EPA) 2013 MSW statistics.

According to information in a confidential attachment to the EA, total annual emissions of greenhouse gases represented as CO2-equivalent (CO2-e) in metric tons (mT), are well below the 25,000 mT GHG reporting threshold described in 40 CFR 98.2. Therefore, no significant impacts are expected from incineration of the FCS at MSW combustion facilities.

Use of the FCS in the fabrication of food-contact materials is not expected to result in a net increase in the use of energy and resources, because the FCS is intended to replace similar substances. Polyamides are not ordinarily used to manufacture bottles; therefore, no impacts on recycling are expected.

No significant environmental impacts are expected from use and disposal of the FCS; therefore, no mitigation measures are needed. The alternative of not allowing the FCN to become effective would be the continued use of the materials that the subject FCS would otherwise replace; such action would have no environmental impact.

Consequently, we find that use of the FCS in single- and repeat-use food-contact applications as described in FCN 1707 will not cause significant adverse impacts on the human environment. Therefore an environmental impact statement will not be prepared.

Prepared by __________________________________________Date: digitally signed 02-10-2017
Leah D. Proffitt
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: digitally signed 02-10-2017
Suzanne Hill
Environmental Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration