Environmental Decision Memo for Food Contact Notification No. 1738

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FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1738), submitted by Enviro Tech Chemical Services, Inc., to allow for the safe use of a solution of an aqueous mixture of peroxyacetic acid (PAA), hydrogen peroxide (H2O2), acetic acid (AA), 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP), and optionally sulfuric acid (SA) as an antimicrobial agent in process water or ice used in the production, processing and preparation of meat, fruits, and vegetables.

The Office of Food Additive Safety has determined that allowing this FCN 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 submitter in an environmental assessment, dated January 16, 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 food-contact substance (FCS) will be used in the following concentrations:

1200 ppm PAA, 275 ppm H2O2, and 33 ppm HEDP in process water or ice used for washing, rinsing, or cooling whole or cut meat, including hides, carcasses, parts, trim and organs;
500 ppm PAA, 115 ppm H2O2, and 14 ppm HEDP in process water or ice used for washing or chilling fruits and vegetables in food processing facilities.

The FCS is intended to inhibit the growth of undesirable or pathogenic microorganisms on meat and produce, as described above. 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. The proposed uses in meat and fruits & vegetables yield environmental introduction concentrations (EIC) of 33 ppm and 14 ppm respectively. Applying the 80:20 partitioning factors yields an effective environmental concentration (EEC) in sludge of 33 ppm x 0.8 = 26.4 ppm for meat processing, and 14 ppm x 0.8 = 11.2 ppm for fruits and vegetables. The aquatic EICs for each use are 33 ppm x 0.2 = 6.6 ppm for meat, and 14 ppm x 0.2 = 2.8 ppm for fruits and vegetables. In order to arrive at the 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 = EEC). Therefore, for meat the aquatic EEC is 6.6 ppm ÷ 10 = 0.66; for fruits and vegetables, it is 2.8 ppm ÷ 10 = 0.28 ppm.

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 26.4 ppm or 11.2 ppm HEDP. Similarly, discharge to surface waters of effluent containing 0.66 ppm or 0.28 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 02-17-2017
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 02-17-2017
Suzanne Hill
Environmental Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration