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Environmental Decision Memo for Food Contact Notification No. 1691

Environmental Decision Memo for Food Contact Notification No. 1691

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: November 17, 2016

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

Subject: Food Contact Notification (FCN) 1691 – Trimethylolpropane (CAS Reg. No. 77-99-6

Notifier: Henan Billions Chemicals Co. Ltd., Billions Europe Ltd., and Billions America Corporation

To: Hui C. Chang, Ph.D., Division of Food Contact Notifications (HFS-275)
Through: Suzanne Hill, Environmental Team Supervisor, Office of Food Additive Safety, HFS-255

Attached is the Finding of No Significant Impact (FONSI) for food contact notification (FCN) 1691.

After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated August 25, 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 (FCS).

Mariellen Pfeil

Attachment: Finding of No Significant Impact


FINDING OF NO SIGNIFICANT IMPACT

A food contact notification (FCN No. 1691), submitted by Keller and Heckman, LLP on behalf of Henan Billions Chemicals Co. Ltd., Billions Europe Ltd., and Billions America Corporation, to provide for the safe use of Trimethylolpropane (CAS Reg. No. 77-99-6) as a dispersant for pigments, except for use in contact with infant formula and human milk. The FCS will be used (1) at levels up to 0.6 percent by weight of the pigment when the pigment is used as a colorant, complying with 21 CFR 178.3297 (Colorants for Polymers), in all types of polymers; and (2) at levels up to 1.0 percent by weight of the pigment when the pigment is used in inks that may come into contact with food. The finished polymers and inks may contact all food types under Conditions of Use A through H.

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 August 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 FCS is intended to aid in the milling or micronization step in the manufacture of pigments and facilitates the dispersibility of the pigments during the manufacture of materials to which the pigments are added. These final 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. Materials containing the FCS are not expected to be recycled. No significant effect on the concentrations of and exposures to any substances in air, water or soil are anticipated. Worst-case (i.e., no dilution) FCS migration into surface water is 100 fold lower than the lowest acute ecotoxicity endpoint. The FCS is comprised of carbon, oxygen and hydrogen only so 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 Part 60 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 the incineration of the FCS. Thus, the use of the FCS as proposed is not expected to result in environmental impacts requiring mitigation measures.

The FCS is manufactured from raw materials that are already produced for various uses. It is intended to replace an identical material currently used in food contact applications. Thus, significant impacts to use of energy and resource 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 environmental impact.

As evaluated in the EA, the use of the FCS as described in FCN 1691 will not significantly affect the human environment. Therefore, an environmental impact statement will not be prepared.

Prepared by __________________________________________Date: Digitally signed 11-17-2016
Mariellen Pfeil
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________ Date: Digitally signed 11-17-2016
Suzanne Hill
Environmental Team Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration