Environmental Decision Memo for Food Contact Notification No. 1810

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FINDING OF NO SIGNIFICANT IMPACT

Proposed Action: Food Contact Substance (FCS) Notification (FCN) 1810, submitted by BioSafe Systems LLC for the use of an aqueous mixture of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidine-1, 1-disphosphonic acid (CAS Reg. No. 2809-21-4), and optionally sulfuric acid (CAS Reg. No. 7664-93-9) as an antimicrobial in process water, brine, and ice used in the production and preparation of whole or cut meat. The components of the FCS mixture will not exceed 1800 ppm peroxyacetic acid (PAA), 675 ppm hydrogen peroxide (HP), and 51.4 ppm 1-hydroxyethylidine-1, 1-disphosphonic acid (HEDP) in process water, brine, or ice used for washing, rinsing, or cooling whole or cut meat, including carcasses, parts, trim, and organs.

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 (EIS) will not be prepared. This finding is based on information submitted by the notifier in an environmental assessment (EA), dated August 2, 2017. The EA was prepared in accordance with 21 CFR 25.40. The EA is incorporated by reference in this Finding Of No Significant Impact (FONSI), and is briefly summarized below.

Manufacture of the FCS is not expected to result in environmental introduction, nor adverse environmental impact. When the FCS is used as an antimicrobial at meat processing plants, environmental introduction could occur via wastewater. It is expected that wastewater from an on-site wastewater treatment facility will discharge to a Publicly Owned Treatment Works (POTW) or, if in possession of a National Pollutant Discharge Elimination System (NPDES) permit, directly to surface waters. Land application of sewage treatment sludge could result in terrestrial introduction of the FCS.

As discussed in the EA, complete degradation of the FCS components (except HEDP) is expected during treatment at the on-site wastewater treatment plant or POTW. Specifically, peroxyacetic acid will breakdown into oxygen, water and acetic acid, while hydrogen peroxide will break down into oxygen and water. Acetic acid is expected to dissociate in wastewater and degrade at the wastewater treatment facility/POTW. Sulfuric acid will completely dissociate into sulfate ions and hydrated protons, neither of which are a toxicological or environmental concern at the proposed use levels. As such, the environmental impacts of these FCS components are not considered in further detail in the EA. The EA focuses on the environmental fate and effects of HEDP.

Assuming, as a worst-case, that all the water used in a processing plant is treated with the FCS, the maximum concentration of HEDP in wastewater would be 51.4 ppm (per the specifications of this FCN). Environmental Introduction Concentrations (EICs) were calculated assuming 80 percent of the HEDP partitions to sludge during on-site wastewater treatment (and 20 percent of the HEDP remains in the water). Expected Environmental Concentrations (EECs) were calculated assuming a ten-fold dilution when the disposed wastewater mixes with surface waters. Therefore, the terrestrial EEC for HEDP is 41.1 ppm (51.4 ppm * 0.80) and the aquatic EEC for HEDP is 1.0 ppm ([51.4 ppm * 0.20] / 10).

In evaluation of terrestrial toxicity, HEDP shows no toxicity to earthworms at levels up to 1,000 mg/kg (ppm) soil dry weight (No Observed Effect Concentration [NOEC]) and no toxicity to birds at levels up to 284 mg/kg body weight. As shown in the EA, the terrestrial HEDP EEC in sludge is 41.1 ppm, lower than both terrestrial toxicity levels, therefore there is no toxicity expected from land application of sludge that contains HEDP because of the use of the FCS. In evaluation of the aquatic toxicity of the FCS, the lowest relevant HEDP concentration for aquatic toxicity was determined to be the chronic NOEC of 10 ppm for Daphnia magna. Since the calculated aquatic HEDP EEC is 1.0 ppm and is 10-fold lower than the 10 ppm chronic NOEC for Daphnia magna, the use of the FCS is not expected to have an adverse effect on aquatic organisms per the specifications of this FCN.

As indicated in the EA, we do not expect a net increase in the use of energy and resources from the use of the FCS, nor do we expect adverse environmental effects, which would necessitate alternative actions to that proposed in this FCN. The alternative of not approving the action proposed herein would result in the continued use of materials which the FCS would otherwise replace (i.e., similar HEDP stabilized peroxyacetic acid antimicrobial agents already on the market); such action would have no environmental impact. Furthermore, as the use and disposal of the FCS is not expected to result in significant adverse environmental impacts; mitigation measures are not identified.

As evaluated in the EA, the use of the FCS, as described in FCN 1810, as an antimicrobial agent for use in meat processing, will not significantly affect the quality of the human environment; therefore, an EIS will not be prepared.

Prepared by __________________________________________Date: digitally signed 09-21-2017
Sarah C. Winfield
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: digitally signed 09-21-2017
Mariellen Pfeil
Biologist / Acting Lead, Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration