Environmental Decision Memo for Food Contact Notification No. 1704

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FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1704), submitted by Akzo Nobel Coatings, Inc., to provide for the safe use of dimethyl ether (DME) (CAS Reg. No. 115-10-6), as a solvent/processing aid in the production of poultry collagen used in processed meat products, where the residual level of the FCS in collagen is 3 ppm.

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 October 4, 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 will be used to extract collagen from high-fat content animal skins (specifically poultry) in a closed-loop process that recovers and reintroduces used DME, and consumes less energy than conventional extraction methods that rely on heated water.

The FCS will be produced and used in Europe; thus any potential impacts resulting from manufacture and use are under the jurisdiction of a foreign nation and outside the scope of this action.

The only potential for impacts in the U.S. is from releases of trace amounts (max. 3 ppm) of DME from collagen imported into the U.S. DME is a gas at all ambient conditions, and has been shown to have a short lifetime (approx. 5 days)[1] when released to the environment. Furthermore, DME is not listed as a greenhouse gas in Section 19(i) of Executive Order 13514. Therefore, due to the FCS’s short lifetime and low global warming potential, no adverse environmental effects are expected from releases of trace amounts of DME from imported collagen.

Compared with conventional processes, DME-based collagen extraction requires less time, and consumes less energy and water. DME is also recycled at a rate of almost 100% in a closed-loop system which further contributes to reduced energy use versus traditional processes. Since no adverse environmental effects were identified, no mitigation measures are required or discussed. The alternative to not allowing the FCN to become effective would be the continued use of conventional collagen extraction processes which may use more harmful chemicals, expend more energy for the heating of water used in the process, and generate more waste water.

Consequently, we find that use of the FCS as a solvent/processing aid in the production of poultry collagen used in processed meat products, where the residual level of the FCS in collagen is 3 ppm, will not cause significant adverse impacts on the human environment. Therefore 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

[1] Lifetime is defined as the amount of time it takes a substance to decrease to 36.8% of its original concentration.

See page 28,182 of D. A. Good et.al. “Lifetimes and global warming potentials for dimethyl ether and for fluorinated ethers;” Journal of Geophysical Research Vol. 103, No. D21, pp. 28,181-28,186; November 20, 1998.