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Environmental Decision Memo for Food Contact Notification No. 1769

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.

Date: April 13, 2017

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

Subject: Finding of No Significant Impact for Food Contact Notification (FCN) 1769

Notifier: Dover Chemical Corporation

To: Jessica Urbelis, Ph.D., 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) 1769.

After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated January 23, 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


A food-contact notification (FCN No. 1769), submitted by Dover Chemical Corporation, to provide for the safe use of Phosphorous acid, triphenyl ester, polymer with α-hydro-ɷ-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl esters (CAS Reg. No. 1227937-46-3). The FCS is intended for use as a thermal stabilizer at levels not to exceed 0.20% by weight in linear low density polyethylene (LLDPE), high density polyethylene (HDPE), polypropylene (PP), and high impact polystyrene (HIPS) used as components of polymeric food contact articles in contact with all types of food under FDA Conditions of Use A through H. The FCS may be used in conjunction with triisopropanolamine (CAS Reg. No. 122-20-3) at a maximum use level of 1.5% by weight of the FCS. The FCS is not for use in contact with infant formula and human milk.

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 23, 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 improve the thermal stability of plastic polymers. The FCS will be used in the manufacture of LLDPE, HDPE, PP and HIPS polymers which will be manufactured into finished food contact articles, such as food packaging, storage containers, drinking cups, utensils and plates. These articles will be widely distributed across the country, and therefore disposed of nationwide. The EA focuses on the environmental impacts that may occur from the disposal of the finished food contact articles containing the FCS.

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. Leaching of the FCS into the environment as a result of landfill disposal is unlikely in light of the U.S. Environmental Protection Agency’s (EPA’s) regulations governing municipal solid waste landfills. The FCS is comprised of carbon, hydrogen and phosphorous and will not significantly alter the emissions from properly operating MSW combustion facilities, and 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 disposal of food contact articles containing the FCS is not reasonably expected to result in significant environmental impacts. As no significant impacts were identified, mitigation measures are not required.

The FCS is manufactured from raw materials that are already produced for various uses. It is intended to replace similar phosphite stabilizers currently used in food contact applications. Thus significant impacts to the use of energy and resources or to polymer recycling programs 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 evaluated in the EA, the use of the FCS as described in FCN 1769 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
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

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