Environmental Decision Memo for Food Contact Notification No. 1727

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FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1727), submitted by CraftChem, Inc., to provide for the safe use of an aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (H2O2) (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and optionally sulfuric acid (CAS Reg. No. 7664-93-9); as an antimicrobial agent in process water used to wash raw and processed fruits and vegetables in food-processing facilities.

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 November 17, 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 subject food-contact substance (FCS) will be used as an antimicrobial agent in process water used to wash raw and processed fruits and vegetables in food-processing facilities. The components of the FCS mixture will not exceed 350 ppm PAA, 117 ppm H2O2, and 4 ppm HEDP.

Waste water from the above-described use will be either discharged ultimately to a publicly-owned treatment works (POTW), or, if in possession of a National Pollutant Discharge Elimination System (NPDES) permit, directly to surface waters after onsite pre-treatment.

The peroxygen components of the FCS (PAA, H2O2) are expected to degrade rapidly in the presence of organic material. Acetic acid readily biodegrades, and sulfuric acid dissociates in the presence of water. Thus, the chemically stable phosphonate HEDP is the component of environmental concern. HEDP is a chelating agent and exhibits unique partitioning behavior such that 80% adsorbs to wastewater treatment sludge, while the remaining 20% stays in the water. Since the proposed HEDP use level of 4 ppm is below the aquatic ecotoxicity endpoint for HEDP of 10 ppm, the analysis of environmental impacts focuses on the HEDP use concentration. Applying the 80:20 partitioning factors yields an environmental introduction concentration (EIC) in sludge of 4 ppm x 0.8 = 3.2 ppm and an EIC of 0.8 ppm in water. In order to arrive at the effective environmental concentration (EEC) in water, a 10-fold dilution factor is applied to the HEDP that remains in water to account for dilution upon release to surface water: EIC ÷ 10 = 0.08 ppm EEC.

HEDP shows no toxicity to terrestrial organisms at levels up to 1000 mg/kg soil dry weight (Eisenia foetida, No Observed Effect Concentration; NOEC), and the lowest relevant endpoint for aquatic toxicity was determined to be the chronic NOEC of 10 ppm for Daphnia magna. Therefore, there is no toxicity expected from land application of sludge containing 3.2 ppm HEDP or discharge to surface waters of effluent containing 0.08 ppm HEDP. No air releases are expected; therefore, impacts to air resources were not analyzed in detail in the EA.

Use of the FCS is not expected to cause a significant impact on resources or energy. The FCS is expected to compete with, and to some extent replace, similar antimicrobial agents already on the market. No mitigation measures are needed since no significant adverse impacts are expected from use of the FCS. The alternative to not allowing the FCN to become effective would be continued use of currently approved antimicrobial agents; such action would have no environmental impact.

As evaluated in the EA, the use of the FCS as an antimicrobial agent in process water used to wash raw and processed fruits and vegetables in food-processing facilities will not significantly affect the human environment, and, therefore an environmental impact statement will not be prepared.

Prepared by __________________________________________Date: digitally signed 12-06-2016
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 12-08-2016
Suzanne Hill
Environmental Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration