Environmental Decision Memo for Food Contact Notification No. 1763

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FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1763), submitted by Kuraray Co., Inc., to provide for the safe use of 2-methylene-1,3-propanediol (MPDiol)-modified ethylene-vinylalcohol (EVOH) copolymer (CAS Reg. No. 1485481-35-3) as a component of films, bottles, and molded articles that may contact food types A through H at levels not to exceed 3 percent in the manufacture of MPDiol-modified EVOH copolymers.

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 February 22, 2017. 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 used to manufacture modified EVOH copolymers that have the same superior gas barrier properties as unmodified EVOH, thereby preventing oxygen from entering the packaging and spoiling its contents. Items containing the FCS are expected to be land disposed, combusted, or recycled proportionately with disposal patterns described in U.S. Environmental Protection Agency’s (EPA) report “Advancing Sustainable Materials Management: Facts and Figures 2014.” Discarded items will go 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) 2014 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.

No significant environmental impacts are expected from use and disposal of the FCS; therefore, mitigation measures have not been identified. 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 as a component of films, bottles, and molded articles that may contact food types A through H, as described in FCN 1763, will not cause significant adverse impacts on the human environment. Therefore, an environmental impact statement will not be prepared.

Prepared by __________________________________________Date: digitally signed 04-04-2017
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 04-04-2017
Suzanne Hill
Environmental Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration