Environmental Decision Memo and EA Revision Sheet for Food Contact Notification No. 1718

Return to inventory listing: Inventory of Environmental Impact Decisions for Food Contact Substance Notifications or the Inventory of Effective Food Contact Substance Notifications.

FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN 1718), submitted by Keller and Heckman on behalf of DIC Corporation to provide for the safe use of polyurethane adhesive formulated with:

Polyester resins prepared by the reaction of a mixture of acids and alcohols listed in 21 C.F.R. § 175.300 (b)(3)(vii);
Isocyanate hardeners consisting of one or more of the following (1) m-xylylene diisocyanate (CAS Reg. No. 3634-83-1), (2) m- xylylene diisocyanate-trimethylol propane prepolymer (CAS Reg. No. 51852-81-4), (3) 2-ethyl-1-hexanol reaction products with 1,6-diisocyanatohexane, (4) 1,6-diisocyanatohexane (CAS Reg. No. 822-06-0), and (5) prepolymers of them.
Optional use, in either the urethane hardener or polyester resin portions of the resin, of trimethoxysilane coupling agents containing amino, epoxy, ether, or mercapto groups comprising not more than 3 percent by weight of the cured adhesive and/or the triethoxysilane coupling agent described in the notification.
(d) An inorganic filler must be included in the adhesive as described in the notification.

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, dated October 25, 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 food contact substance (FCS) is for use as an adhesive and oxygen barrier in laminate structures that are intended for use in contact with food.

The adhesive may be used at levels up to 5 g/m2 for conventional films, and up to 3.5 g/m2 for metalized films. A food-contact layer consisting of co-polymer polypropylene with a minimum thickness of 70 micrometers or another material with equivalent or greater barrier properties will separate the adhesive from food. The finished article may contact all types of food under Conditions of Use A through H. The finished food contact articles containing the FCS are not for use in contact with infant formula and breast milk.

The polyurethane food-contact substance is needed to provide for an alternative laminating adhesive.

There are no extraordinary circumstances associated with the manufacture of the FCS.

The FCS will be sold to manufacturers engaged in the production of laminated films. Food-contact articles produced with the FCS will be utilized in patterns corresponding to the national population density and will be widely distributed across the country. Therefore, it is anticipated that disposal will occur nationwide, with about 80% of the materials being land disposal sites, and about 20% combusted.

Impacts to the Environment as a Result of Use and Disposal

No environmental release is expected upon the use of the FCS to fabricate food-contact materials as the subject substance is to be entirely incorporated into the food-contact article. Food contact articles containing the FCS are expected to be disposed of either by land disposal in a landfill or by combustion at a municipal solid waste (MSW) combustion facility.

Land Disposal
Because of the Environmental Protection Agency’s (EPA’s) regulations governing landfills (40 CFR Part 258), only extremely small amounts , if any, of the FCS is expected to enter the environment as a result of the landfill disposal of food-contact articles manufactured with the FCS. Therefore, no significant environmental impacts are anticipated resulting from land disposal of the FCS.

Combustion
Based on the proposed use of the FCS, chemical composition, and confidential market volume information, combustion of the FCS will not cause municipal solid waste combustors to threaten a violation of applicable emissions laws and regulations such as 40 CFR Part 60 and/or relevant state and local laws.

MSW combustion facilities that emit 25,000 metric tons carbon dioxide equivalents (CO2-e) or more per year are required to report their greenhouse gas (GHG) emission per the Environmental Protection Agency’s Greenhouse Gas Reporting Program (EPA GHGRP) which is cited at 40 CFR 98.2. To evaluate the significance of the environmental impact of these GHG emissions, we refer to the Council on Environmental Quality (CEQ) regulations under 40 CFR 1508.27, which defines 'significantly' as it relates to assessing the intensity of an environmental impact in NEPA documents. 40 CFR 1508.27(b)(10) states, that when evaluating intensity of an impact, one should consider "whether the action threatens a violation of Federal, State, or local law or requirements imposed for the protection of the environment." GHG emissions from MSW combustion facilities are regulated under 40 CFR 98.2.

The FCS consists of carbon, oxygen, hydrogen, and nitrogen and optionally silicon. As the FCS consists of carbon and nitrogen, the GHGs carbon dioxide and nitrous oxide are anticipated to be released upon combustion of the FCS. As such, an estimation of GHG emissions is included in a confidential attachment to the EA. The amount of GHG emissions that result from the combustion of food contact articles manufactured from the FCS are below the regulated 25,000 annual metric ton threshold for EPA GHGRP. Therefore, no significant environmental impacts are anticipated resulting from combustion of the FCS in MSW facilities.

Recycling
Food contact articles manufactured with the FCS are not expected to be recovered for recycling; therefore the FCS is not expected to have an impact on current or future recycling programs. This conclusion is supported by the Canadian Plastics Industry Association Packaging Industry Report of 2013 which demonstrates that recycling of multilaminate films in North America is negligible. Because recycling of food-contact materials containing the FCS will be negligible, and the intended use is not expected to impact recycling operations, significant environmental impacts are not anticipated.

Use of Resources and Energy

The FCS will replace similar materials now on the market for use in the same food packaging applications. Use of the FCS will consume energy and resources in amounts comparable to the manufacture and use of similar adhesives. As such, partial replacement by the FCS is not expected to have any adverse impact on the use of energy and resources as manufacture of the subject substance. Additionally, as recycling of multi-laminate films in North America is negligible, the FCS will not have an impact on current or future recycling programs.

Mitigation Measures

No significant adverse environmental impacts are expected to result from the use and disposal of the FCS. Therefore, mitigation measures are not identified in the EA.

Alternatives to the Proposed Action

No potential adverse environmental effects were identified in the EA that would necessitate alternative actions for the proposed use in this FCN. If the proposed action is not approved, the result would be the continued use of the materials that the FCS would replace. Such action would have no environmental impact.

As evaluated in the EA, the proposed use of the FCS as an adhesive and oxygen barrier in laminate structures intended for use in contact with food, as described in FCN 1718 will not significantly affect the human environment; therefore, an environmental impact statement will not be prepared.

Prepared by __________________________________________Date: digitally signed 01-19-2017
Antonetta Thompson-Wood
Physical Scientist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: digitally signed 01-19-2017
Suzanne Hill
Environmental Team Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

U.S. Food and Drug Administration Revision Sheet for the October 25, 2016 EA for FCN 1718

Dated: January 19, 2017

U.S. Food and Drug Administration (FDA) in its review of the Environmental Assessment (EA) of October 25, 2016 for food contact notification (FCN) 1718 concluded that the action will not constitute a significant impact. This revision is issued to make a minor change and clarification that should be acknowledged, while not making any substantive changes to the EA. This revision does not impact our Finding of No Significant Impact (FONSI) and is as follows:

On page 1, paragraph 1, item (d), the last sentence should read "(d) An inorganic filler must be included in the adhesive as described in the notification".