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: November 28, 2016

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

Subject: Finding of No Significant Impact for Food Contact Notification (FCN) 1685 for copolymer of glycidyl methacrylate and ethylene glycol dimethacrylate with 1,6-diaminohexane or ethylenediamine, as a solid support for the ionic immobilization of enzyme preparations used in the production of wheat and corn-based sweeteners, sugar solutions, and artificial sweeteners, except for use in contact with infant formula or ingredients used for making infant formula. The FCS is intended for use in repeat-use applications.

Notifier: Purolite Corporation.

To: Marla Swain, Ph.D., 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 FCN 1685 for copolymer of glycidyl methacrylate and ethylene glycol dimethacrylate with 1,6-diaminohexane or ethylenediamine.

After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated August 9, 2016, may be made available to the public. We will post digital transcriptions of the FONSI and the environmental assessment 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.

Leah D. Proffitt

Attachment: Finding of No Significant Impact

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FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1685), submitted by Purolite Corporation, to provide for the safe use of a copolymer of glycidyl methacrylate and ethylene glycol dimethacrylate with 1,6-diaminohexane or ethylenediamine, as a solid support for the ionic immobilization of enzyme preparations used in the production of wheat and corn-based sweeteners, sugar solutions, and artificial sweeteners. The FCS is intended for use in repeat-use applications.

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 August 9, 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.

At the end of the immobilized enzyme's useful lifetime 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 generated in 2013, compared with U.S Environmental Protection Agency's 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] According to this guidance, GHG emissions should be quantified and used as a proxy for assessing potential climate change impacts from an action. However, as the FCN was submitted prior to the issuance of the final CEQ GHG guidance, the EA follows recommendations found in the December 2014 revised draft guidance. Based on information included in a confidential attachment to the EA, GHG emissions from incineration of the FCS are expected to fall below the 25,000 mT reporting threshold mentioned in the draft guidance document. Therefore, incineration of the FCS at MSW combustion facilities is not expected to significantly contribute to climate change.

The use of the FCS in the manufacture of food is not expected to result in a net increase in the use of energy and resources since the FCS is intended to be used in place of other enzyme support materials currently on the market for use in the production of food and/or food additives. Manufacture of the FCS will consume energy and resources in amounts comparable to the manufacture of other similar materials. The raw materials that are used in the manufacture of the FCS are commercially manufactured chemicals that are produced for use in various chemical reactions and used for production purposes. 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. Since no significant environmental impacts were identified, no mitigation is required or discussed.

Therefore, we find that use of the FCS as a solid support for the ionic immobilization of enzyme preparations used in the production of wheat and corn-based sweeteners, sugar solutions, and artificial sweeteners will not cause significant adverse impacts on the human environment and 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

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^[1] Available at CEQ Releases Final Guidance on Greenhouse Gases and Climate Change