Environmental Decision Memo for Food Contact Notification No. 1743

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FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1743), submitted by Agri-Neo, Inc., to allow for the safe use of a solution of an aqueous mixture of peroxyacetic acid (PAA), hydrogen peroxide (H2O2), acetic acid (AA), sulfuric acid (SA), and 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) as an antimicrobial for use as a spray on select edible seeds(e.g. chia, flax, hemp) and nuts (e.g. almond, cashew, and walnut).

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 February 13, 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 manner and concentrations: 229 ppm PAA, 1,043 ppm H2O2, 388 ppm AA, 48 ppm SA, and 25 ppm HEDP on treated shells and nuts. The seeds and nuts shall be subject to either a rinse with potable water or a water-ethanol mixture after treatment. The treated edible seeds can be consumed directly or further processed info flour, protein, or oil. Treated nuts are not intended to be further processed.

The FCS—known commercially as Neo-Pure®--is intended to inhibit the growth of undesirable or pathogenic microorganisms on edible seeds and nuts, as described above. The FCS is applied only once, at a maximum use rate of 4L on Neo-Pure® per 1 metric ton (1000 kg) of seeds or nuts to yield the above-listed concentrations on seeds/nuts. 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. Similarly, ethanol emissions from the optional ethanol-water rinse are expected to be minimal compared with national anthropogenic ethanol emissions. Thus, the chemically stable phosphonate HEDP is the component of environmental concern. It is important to note that the above-cited HEDP use concentration of 25 ppm accounts for adsorption of some HEDP by the seeds. As a conservative, worst-case approach, the analysis of environmental impacts is based on a concentration of 154 ppm HEDP; a theoretical scenario wherein all HEDP is rinsed off the seeds and into effluent.

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. Applying the 80:20 partitioning factors to the above-described worst-case concentration of 154 ppm HEDP yields an effective environmental concentration (EEC) in sludge of 154 ppm x 0.8 = 123.2 ppm. The aquatic environmental introduction concentration (EIC) is 154 ppm x 0.2 = 30.8 ppm. 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, the aquatic EEC is 30.8ppm ÷ 10 = 3.08 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 123.2 ppm HEDP. Similarly, discharge to surface waters of effluent containing 3.08 ppm HEDP is not expected to have toxic effects.

Use of the FCS is not expected to cause a significant impact on resources or energy. The no-action alternative would be treatment via pasteurization, a technology that uses heat and may be expected to consume more energy than the proposed use. 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 or treatment via pasteurization; such action would have no significant environmental impact.

As evaluated in the EA, the use of the FCS as described in FCN 1743 is not expected to significantly affect the human environment, and, therefore an environmental impact statement will not be prepared.

Prepared by __________________________________________Date: digitally signed 04-12-2017
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 04-12-2017
Suzanne Hill
Environmental Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration