Environmental Decision Memo for Food Contact Notification No. 1647

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FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1647), submitted by Keller and Heckman LLP on behalf of Sumitomo Chemical Co., Ltd., to provide for the safe use of a copolymer of 4-hydroxybenzoic acid, 4,4'-dihydroxybiphenyl, terephthalic acid, and isophthalic acid (CAS Reg. No. 60088-52-0) for use as a component of articles used in contact with all types of food, except for use in contact with infant formula and breast 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, dated March 14, 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 provide a product that has high thermal and chemical stability and excellent mechanical properties to the marketplace. The FCS will be manufactured into thermoformed or injection molded food-contact articles (excluding beverage bottles). 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 combustors complying with 40 CFR Parts 258 and 60, respectively. No significant effect on the concentrations of and exposures to any substances in air, water or soil are anticipated. Finished articles containing the FCS are expected to be of high molecular weight, and are not volatile or likely to leach. The FCS is comprised of carbon, hydrogen and oxygen only so will not significantly alter the emissions from properly operating MWC units, 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, the expected CO2-e emissions fall below the CEQ threshold for quantitative disclosure. Thus the use of the FCS as proposed is not reasonably 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 similar crystalline PET polymers currently used in food packaging 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 1647 will not significantly affect the human environment. Therefore an environmental impact statement will not be prepared.

Prepared by ____________________________________________Date: digitally signed on 05-12-2016
Mariellen Pfeil
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by ____________________________________________Date: digitally signed on 05-18-2016
Suzanne Hill
Environmental Team Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration