Environmental Decision Memo for Food Contact Notification No. 1694

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FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1694), submitted by Alex C. Ferguson, LLC (AFCO), 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 (AA) (CAS Reg. No. 64-19-7), optional sulfuric acid (SA) (CAS Reg. No. 7664-93-9) and 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4); as an antimicrobial agent as specified below.

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 August 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 subject food-contact substance (FCS) will be used as an antimicrobial agent in the control of microorganisms commonly encountered in food processing and production in the following applications and concentrations:

1800 ppm PAA, 600 H2O2, 12 ppm HEDP in process water or ice used for washing, rinsing, or cooling whole or cut meat including carcasses, parts, trim, and organs;
495 ppm PAA, 165 ppm H2O2, 6 ppm HEDP in process water, brine, or ice used for washing, rinsing, or cooling processed and pre-formed meat as defined in 21 CFR 170.3(n)(29);

Waste water from the above-described uses will be either discharged via onsite wastewater treatment 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 phoshonate 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 HEDP use level associated with processed and pre-formed meat (number 2 above), is below the aquatic ecotoxicity endpoint for HEDP of 10 ppm, the analysis of environmental impacts focuses on the HEDP concentration used in whole or cut meat, i.e. 12 ppm HEDP. Applying the 80:20 partitioning factors yields an environmental introduction concentration (EIC) in sludge of 12 ppm x 0.8 = 9.6 ppm and an EIC of 2.4 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 = 0.24 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 9.6 ppm HEDP or discharge to surface waters of effluent containing 0.24 ppm HEDP. No air releases are expected; therefore, the air component was omitted from discussion.

Use of the FCS is not expected to cause a significant impact on resources or energy. The FCS is made in a PAA manufacturing facility with existing fixed costs that would not be increased in a significant way by the manufacture of this FCS. The ingredients used in the manufacture of the FCS are purchased in bulk quantities for several other products already manufactured by the notifier, and this FCS would not pose a significant additional burden on those requirements.

No mitigation measures are needed since no significant adverse impacts are expected from use of the FCS. The alternative of not approving the FCN would be cross-contamination from re-use of marinades.

As evaluated in the EA, the use of the FCS as an antimicrobial agent in: (1) process water or ice used for washing, rinsing, or cooling whole or cut meat including carcasses, parts, trim, and organs; and (2) in process water, brine, or ice used for washing, rinsing, or cooling processed and pre-formed meat as defined in 21 CFR 170.3(n)(29) will not significantly affect the human environment, and, therefore an environmental impact statement will not be prepared.

Prepared by __________________________________________Date: digitally signed 09-12-2016
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 09-12-2016
Suzanne Hill
Environmental Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration