Environmental Decision Memo for Food Contact Notification No. 1684

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FINDING OF NO SIGNIFICANT IMPACT

Proposed Action: Food-contact notification (FCN) No. 1684, submitted by Asahi Kasei Corporation, for use of the food-contact substance (FCS) 2-Propenoic acid, 2-methyl-, polymer with ethenylbenzene and methyl 2-methyl-2-propenoate (CAS Reg. No. 25035-81-8) as a component of food packaging films for use at a maximum thickness of 50 μm in contact with dry foods with surface containing no fat or oil (i.e., Food Type VIII) under Conditions of Use E and F, as described in Tables 1 and 2, respectively. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.

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 August 8, 2016. The EA is incorporated by reference in this Finding of No Significant Impact (FONSI), and is briefly summarized below. The EA was prepared in accordance with 21 CFR 25.40.

The FCS is a basic resin for use as a component of food packaging films. The FCS is manufactured in Japan, and there are no extraordinary circumstances associated with the manufacture of the FCS. Therefore, the evaluation in the EA focuses on the use and disposal of food contact articles made with the FCS, which will occur nationwide. The food contact articles in which the FCS will be used are not expected to be recycled (to any significant extent). Consequently, the FCS is expected to be primarily land disposed (80.4% of the FCS) and secondarily, incinerated (19.6% of the FCS).

Based on confidential market volume information provided in a confidential attachment to the EA, the FCS will make up a small portion of the total municipal solid waste (MSW) landfilled and incinerated. Both the marginal amount of the FCS landfilled compared to all MSW landfilled, as well as the Environmental Protection Agency’s (EPA) regulations governing landfills (40 CFR Part 258), result in negligible amounts (if any) of the FCS expected to enter the environment (land, and to an even lesser extent water). Additionally, as the FCS is a high molecular weight polymer, no significant quantities are expected to volatilize or release into the air upon use and disposal of the FCS. Further, the products of complete combustion for the FCS are not expected to alter the emissions from properly operating MSW combustors, and therefore not expected to threaten a violation of 40 CFR 60 (and, as discussed above, the FCS will make up a very small portion of the total MSW combusted).

The greenhouse gas (GHG) carbon dioxide is anticipated to be released upon combustion of the FCS, therefore an estimation of GHG emissions is included in a confidential attachment to the EA. Total estimated GHG emissions resulting from the use of the FCS per FCN 1684 are well below the 25,000 metric tons carbon dioxide equivalents (CO2-e) or more per year threshold established by the Council on Environmental Quality (CEQ) in their revised draft guidance.^[1] When the CEQ GHG threshold is exceeded, quantitative disclosure is warranted. Based on the analysis provided in a confidential attachment to the EA, estimated GHG emissions are well below the CEQ GHG threshold; therefore, quantitative disclosure is not warranted.

As indicated in the EA, we do not expect a net increase in the use of energy and resources from the use of the FCS, nor do we expect adverse environmental effects, which would necessitate alternative actions to that proposed in this FCN. The alternative of not approving the action proposed herein would result in the continued use of the materials which the FCS would otherwise replace; such action would have no environmental impact. Furthermore, as the use and disposal of the FCS is not expected to result in significant adverse environmental impacts; mitigation measures are not identified.

As evaluated in the EA, the use of the FCS, as described in FCN 1684, as a component of food packaging films, will not significantly affect the quality of the human environment; therefore, an environmental impact statement will not be prepared.

Prepared by __________________________________________Date: digitally signed 10-14-2016
Sarah C. Winfield
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: digitally signed 10-14-2016
Suzanne Hill
Environmental Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

^[1] As the FCN was submitted prior to issuance of the final guidance, the EA follows recommendations in the revised draft guidance.