Environmental Decision Memo for Food Contact Notification No. 1698

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FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1698), submitted by Mitsubishi Gas Chemical Co., Inc., to provide for the safe use of trimethylolpropane (CAS Reg. No. 77-99-6), at levels not to exceed 0.45 percent by weight of pigment, as a milling aid and dispersant for pigments used as components of food-contact articles.

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 12, 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 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.

On August 1, 2016, the Council on Environmental Quality (CEQ) issued final guidance on addressing greenhouse gases (GHG) and climate change impacts in EAs and EISs[1]. The GHG emissions resulting from the use and disposal of the FCS relate to the incineration in MSW combustion facilities of articles containing the FCS. Such facilities are regulated by EPA under 40 C.F.R. § 98, which “establishes mandatory GHG reporting requirements for owners and operators of certain facilities that directly emit GHG.” Part 2 of this regulation (40 C.F.R. § 98.2) describes the facilities that must report GHG emissions and sets an annual 25,000 metric ton carbon dioxide equivalent (CO2-e) emission threshold for required reporting. 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.

Furthermore, consumption and subsequent elimination by consumers of minute amounts of the FCS that may migrate to food is not expected to adversely affect the environment: based on migration calculations, the total concentration of the FCS in the diet is estimated to be 68 ppb. It is assumed, as a worst-case, that the FCS is eliminated unchanged and that no dilution occurs upon entry into surface waters (i.e. the expected environmental concentration—EEC—is 68 ppb). Given that the lowest acute ecotoxicity endpoint is 5 ppm (24 h LC50 for sea lamprey), no adverse environmental impacts are expected from this route of introduction.

The notified use of the FCS will not require additional energy resources for the treatment and disposal of wastes as the FCS is expected to compete with, and to some degree replace similar substances already on the market. Manufacture of the FCS will consume energy and resources in amounts comparable to the manufacture of other similar materials.

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 at levels not to exceed 0.45 percent by weight of pigment, as a milling aid and dispersant for pigments used as components of food-contact articles will not cause significant adverse impacts on the human environment. Therefore an environmental impact statement will not be prepared.

Prepared by __________________________________________Date: Digitally signed 11-28-2016
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 11-28-2016
Suzanne Hill
Environmental Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

[1] Available at Final Guidance on the Consideration of Greenhouse Gas Emissions and the Effects of Climate Change in NEPA Reviews