Environmental Decision Memo for Food Contact Notification No. 1654

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FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1654), submitted by Enviro Tech Chemical Services, 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 in: (1) brines, sauces, and marinades to be applied on the surface or injected into processed or unprocessed, cooked or uncooked whole or cut poultry or parts and pieces and (2) surface sauces and marinades applied on processed and preformed meat and poultry products as described in 21 CFR 170.3(n)(29) and (34).

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 April 11, 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 in brines and marinades applied or injected in commercially processed meat and poultry products. The need for the action arises from the fact that brines and marinades are recovered and re-applied over a four-hour period, and may otherwise become contaminated if not treated with an antimicrobial.

At the end of a four-hour use period, unused brine is 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, , and acetic acid readily biodegrades; 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. Based on confidential information submitted with the EA, the worst-case HEDP concentration discharged after four hours is 6.05 ppm; this value is assumed to be the environmental introduction concentration (EIC). Applying the 80:20 partitioning factors yields an effective environmental concentration (EEC) in sludge of 6.05 x 0.8 = 4.84 ppm. For 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 x 0.2) ÷ 10 = 0.121 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 4.84 ppm HEDP or discharge to surface waters of effluent containing 0.121 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) brines, sauces, and marinades to be applied on the surface or injected into processed or unprocessed, cooked or uncooked whole or cut poultry or parts and pieces and (2) surface sauces and marinades applied on processed and preformed meat and poultry products as described in 21 CFR 170.3(n)(29) and (34) will not significantly affect the human environment, and, therefore an environmental impact statement will not be prepared.

Prepared by __________________________________________Date: Digitally signed 05-12-2016
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 05-16-2016
Suzanne Hill
Environmental Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration