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

See also Environmental Decisions.

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Date: April 13, 2017

From: Biologist, Division of Biotechnology and GRAS Notice Review (HFS-255)

Subject: Finding of No Significant Impact for Food Contact Notification (FCN) 1770

Notifier: Dover Chemical Corporation

To: Kenneth McAdams, Consumer Safety Officer, Division of Food Contact Notifications (HFS-275)
Through: Suzanne Hill, Environmental Supervisor, Office of Food Additive Safety (HFS-255)

Attached is the Finding of No Significant Impact (FONSI) for food-contact notification (FCN) 1770.

After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated January 24, 2017 may be made available to the public. We will post digital transcriptions of the FONSI and the EA on the agency's public website.

Please let us know if there is any change in the identity or use of the food-contact substance (FCS).

Mariellen Pfeil

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FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1770), submitted by Diam Bouchage SAS, to provide for the safe use of Polyurethane resin produced by reacting a mixture of 2,4-toluene diisocyanate (CAS Reg. No. 584-84-9) and 2,6-toluene diisocyanate (CAS Reg. No. 91-08-7) with polyoxyethylene­polyoxypropylene glyceryl ether (CAS Reg. No. 9082-00-2) and 1,4-butanediol (CAS Reg. No. 110-63-4). The FCS is intended for use as a binder or adhesive in the manufacture of agglomerated cork stoppers that function as closures for alcoholic beverage containers, i.e., Food Types VI-A and VI-C, under FDA Conditions of Use D through G. The FCS is subject to the maximum use level 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 will not be prepared. This finding is based on information submitted by the notifier in an environmental assessment (EA), dated January 24, 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 intended to bind the closure components (e.g., natural cork granules and synthetic particles) together while maintaining the desired viscoelastic properties of the stopper. Finished materials will be widely distributed across the country, and therefore disposed of nationwide.

Post-consumer disposal of the articles which contain the FCS will be to landfills or municipal solid waste (MSW) combustors complying with 40 CFR Parts 258 and 60, respectively or recycled. No significant effect on the concentrations of and exposures to any substances in air, water or soil are anticipated. Recycling is not anticipated. Due to EPA’s regulations governing landfills at 40 CFR Part 258, leaching into the environment of the FCS or its components as a result of land disposal of articles manufactured with the FCS is not anticipated. The FCS is comprised of carbon, oxygen, hydrogen and nitrogen so will not significantly alter the emissions from properly operating MSW combustion facilities. Further incineration of the FCS will not cause municipal waste combustors to threaten a violation of applicable emissions laws and regulations at 40 CFR Parts 60, regulations for mandatory emissions reporting at 40 CFR 98, and/or relevant state and local laws. Based upon an analysis using market volume information provided in the confidential attachment to the EA there are no significant impacts with respect to greenhouse gas emissions resulting from incineration of materials containing the FCS. Thus, the use of the FCS as proposed is not reasonably expected to result in significant environmental impacts.

The FCS is manufactured from raw materials that are already produced for various uses. It is intended for use in closures which will be used in place of similar articles already on the market for use in food-contact applications, such as 100% synthetic, i.e., plastic, bottle closures. Additionally, the FCS is intended to replace similar binders used to manufacture agglomerated corks. Thus, significant impacts to the use of energy and resources are not anticipated.

No potential adverse environmental effects are identified that would necessitate alternative actions to those proposed. The alternative of not approving the notified action would result in the continued use of the materials that the subject FCS would otherwise replace; such action would have no significant environmental impacts. As no significant impacts were identified, mitigation measures are not required.

As evaluated in the EA, the use of the FCS as described in FCN 1770 will not significantly affect the human environment. Therefore, an environmental impact statement will not be prepared.

Prepared by __________________________________________Date: digitally signed 04-13-2017
Mariellen Pfeil
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: digitally signed 04-13-2017
Suzanne Hill
Environmental Team Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration