Environmental Decision Memo for Food Contact Notification No. 1666

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FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1666), submitted by Valley Chemical Solutions to provide for the safe use of an aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9) for use as an antimicrobial agent in process water, brine, or ice for poultry and meat (including livestock and game) products.

The Office of Food Additive Safety has determined that allowing food contact notification (FCN) 1666 to become effective will not significantly affect the quality of the human environment and, therefore, will not require the preparation of an environmental impact statement. This finding is based on information submitted by the notifier in an EA dated June 22, 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 FCS will be used as an antimicrobial agent in process water, brine, or ice for poultry and meat (including livestock and game) products. The components of the FCS mixture in process water, brine, or ice, will not exceed:

2000 parts per million (ppm) PAA, 750 ppm HP, and 10 ppm HEDP in spray, mist, wash, rinse, dip, chiller water, and scald water for meat and poultry carcasses, parts, trim, and organs.
495 ppm PAA, 186 ppm HP, and 2.5 ppm HEDP for washing, rinsing, or cooling processed and pre-formed meat and poultry products.

The FCS is intended for use in meat and poultry processing plants throughout the United States.

The antimicrobial agent is needed to reduce or eliminate pathogenic microorganisms that may be present on the poultry and meat products. Extending the antimicrobial treatment concentration range allows processing plants more flexibility in utilizing and managing dose-responsive interventions.

Introduction of Substances into the Environment as a Result of Use

It is expected that wastewater from on-site wastewater treatment facilities will discharge to publically-owned treatment works (POTWs) or, if in possession of a National Pollutant Discharge Elimination System (NPDES) permit, directly to surface waters. Land application of sewage treatment sludge will result in terrestrial introduction of the FCS.

As discussed in the EA, complete degradation of PAA, HP, AA and sulfuric acid is expected during treatment at the on-site wastewater treatment plant or POTW. Specifically, PAA will breakdown into oxygen, water and acetic acid, while hydrogen peroxide will break down into oxygen and water. Acetic acid is not expected to concentrate in the wastewater discharged to the 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, in the very worst-case, that all of the water used in a processing plant is treated with the FCS at the highest use level concentration (i.e., 10 ppm), the HEDP environmental introduction concentrations (EICs) following on-site wastewater treatment with 80 percent HEDP partition into sewage treatment sludge would be 2 ppm and 8 ppm for the aqueous and sludge compartments, respectively. The expected environmental concentration (EEC), calculated assuming, as a worst-case scenario, that wastewater containing the FCS is discharged directly to surface water with a conservative 10-fold dilution factor is 0.2 ppm.

Terrestrial Ecotoxicity

HEDP shows no toxicity to terrestrial organisms at levels up to 1,000 mg/kg (ppm) soil dry weight (No Observed Effect Concentration [NOEC]). As shown in the EA, the maximum expected environmental concentration (EEC) in sludge is 8 ppm, therefore there is no toxicity expected from land application of sludge that contains HEDP as a result of the use of the FCS.

Aquatic Ecotoxicity

In evaluation of the aquatic toxicity of the FCS, the lowest relevant HEDP endpoint for aquatic toxicity was determined to be the chronic NOEC of 10 ppm for Daphnia magna. The worst-case (i.e., highest HEDP use level) calculated HEDP EEC resulting from processing of meat and poultry is 0.2 ppm and is approximately 50-fold lower than the 10 ppm chronic NOEC for Daphnia magna, therefore use of the FCS is not expected to have an adverse effect on aquatic organisms.

Use of Resources and Energy

The notified use of the FCS mixture will not require additional energy resources for the treatment and disposal of wastes as the FCS is expected to compete with, and to some degree replace similar HEDP stabilized peroxy antimicrobial agents already on the market. The manufacture of the antimicrobial agent will consume comparable amounts of energy and resources as similar products, and the raw materials used in the production of the mixture are commercially manufactured materials that are produced for use in a variety of chemical reactions and processes.

Alternatives to the Proposed Action

No potential adverse environmental effects were identified in the EA that would require evaluation of reasonable alternatives for the proposed use in this FCN. If the proposed action is not approved, the result would be the continued use of the currently marketed antimicrobial agents that the subject FCS would replace. Such action would not have a significant environmental impact.

As evaluated in the EA, the proposed use of the FCS as an antimicrobial agent for use in the processing of meat and poultry and the processing of preformed meat and poultry, as described in FCN 1666, is not expected to have a significant environmental impact; therefore, an environmental impact statement will not be prepared.

Prepared by ____________________________________________Date: digitally signed 09-14-2016
Mariellen Pfeil
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by ____________________________________________Date: digitally signed 09-15-2016
Suzanne Hill
Environmental Team Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration