Environmental Decision Memo and EA Revision Sheet for Food Contact Notification No. 1692

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FINDING OF NO SIGNIFICANT IMPACT

Proposed Action: Food-contact notification (FCN) No. 1692, submitted by Henkel Inc., for use of the food-contact substance (FCS) polyester-polyurethane adhesive formulated as follows: (a) polyurethane component prepared from isophthalic acid, diethylene glycol, adipic acid, 4,4'-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8) and hexamethylene diisocyanate homopolymer (CAS Reg. No. 28182-81-2); and (b) polyester-polyol component prepared from isophthalic acid, diethylene glycol, castor oil, propoxylated glycerol, propoxylated trimethylolpropane and caprolactam.

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 (EIS) will not be prepared. This finding is based on information submitted by the notifier in an environmental assessment (EA), dated August 17, 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 intended for use as an adhesive in laminate structures for use at high temperatures, including microwave reheating. The FCS may be applied at a maximum rate of 2.5 pounds per 3000 square feet of food-contact surface. A food-contact layer will separate the adhesive from food and will consist of low density polyethylene with a minimum thickness of 1 mil or another material with equivalent or greater barrier properties under the intended conditions of use (all food types under Conditions of Use B through H as described in Tables 1 and 2^[1]). 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 FCS will improve adhesion between laminated layers, resulting in fewer lamination failures.

Manufacture of the FCS occurs at plants that meet all federal, state and local environmental regulations; and there are no extraordinary circumstances associated with the manufacture of the FCS. After manufacture, the FCS is incorporated entirely into finished food contact articles; any waste materials are expected to be disposed of in accordance to nonhazardous solid waste procedures.

Once the food contact articles are made, they will be widely distributed, used and disposed of nationwide. Disposal of the food contact articles is expected to follow disposal trends for municipal solid waste (MSW), as reported by the U.S. Environmental Protection Agency (EPA). 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 very small portion of the total MSW landfilled and incinerated.

Because of EPA’s regulations governing landfills (40 CFR Part 258) and the marginal amount of the FCS that would be landfilled only very small amounts of the FCS is expected to be introduced to land, and to an even lesser extent water. Similarly, because of the composition of the FCS and the low market volume of the FCS, it is not anticipated that combustion of the FCS would threaten a violation of EPA regulations governing MSW combustion facilities (40 CFR Part 60). However, when the FCS is combusted, the greenhouse gases (GHG) carbon dioxide and nitrous oxide are anticipated to be released. Accordingly, 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 1692 are 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.^[2] When the CEQ GHG threshold is exceeded, quantitative disclosure is warranted. However, as noted, based on the analysis provided in the confidential attachment to the EA, estimated GHG emissions are below the CEQ GHG threshold; therefore quantitative disclosure is not warranted. In sum, because of the above discussion, we do not expect a significant impact to the environment from the use of the FCS as specified in FCN 1692.

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 1692, as an adhesive in the production of laminate structures intended for contact with food, will not significantly affect the quality of the human environment; therefore, an EIS will not be prepared.

Prepared by __________________________________________Date: digitally signed 10-26-2016
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 10-26-2016
Suzanne Hill
Environmental Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

^[1]Food Types & Conditions of Use for Food Contact Substances

^[2] As the FCN was submitted prior to issuance of the final CEQ GHG guidance, the EA follows recommendations in the revised draft guidance