Environmental Decision Memo and EA Revision Sheet for Food Contact Notification No. 1688

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FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1688), submitted by PeroxyChem, LLC to provide for the safe use of an aqueous mixture of peroxyacetic acid, hydrogen peroxide, acetic acid, 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP), and, optionally, sulfuric acid as an antimicrobial agent in process water and ice used in the production and preparation of meat including processed and pre-formed meat.

The Office of Food Additive Safety has determined that allowing this food contact notification (FCN) 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 July 29, 2016. The environmental assessment (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) is intended for use as an antimicrobial agent in process water and ice used in the production and preparation of meat including processed and pre-formed meat. The components of the FCS mixture will not exceed: (1) for washing, rinsing, or cooling whole or cut meat: 1800 ppm PAA, 1215 ppm hydrogen peroxide (HP), and 121.5 ppm HEDP; and (2) for washing, rinsing, storing, or cooling processed and preformed meat 495 ppm PAA, 335 ppm HP, and 33.5 ppm HEDP. The FCS is intended for use in meat processing facilities throughout the United States. The need for the FCS is to reduce or eliminate pathogenic and non-pathogenic microorganisms that may be present on food.

Introduction of Substances into the Environment as a Result of Use
It is expected that wastewater from an on-site wastewater treatment facility will discharge to a publically-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 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, the HEDP environmental introduction concentrations (EICs) would be 121.5 and 33.5 ppm for meat processing and processed and preformed meat processing, respectively. Expected environmental concentrations (EECs) were calculated assuming, as a worst-case scenario, that wastewater containing the FCS is discharged directly to surface water following on-site wastewater treatment with 80 percent HEDP partitioning to sewage treatment sludge.

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 EEC in sludge is 97.2 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 calculated HEDP EEC resulting from meat processing use is 2.4 ppm and is approximately 5-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 shell eggs is not expected to have a significant environmental impact; therefore, an environmental impact statement will not be prepared for FCN 1688.

Prepared by ____________________________________________Date: digitally signed 10-25-2016
Mariellen Pfeil
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by ____________________________________________Date: digitally signed 10-25-2016
Suzanne Hill
Environmental Team Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

U.S. Food and Drug Administration
Revision Sheet for the July 29, 2016 EA for FCN 1688
Dated: October 25, 2016

U.S. Food and Drug Administration (FDA) in its review of the Environmental Assessment (EA) of July 29, 2016 for food contact notification (FCN) 1688 concluded that the action will not constitute a significant impact. This revision is issued to make a minor change and clarification that should be acknowledged, while not making any substantive changes to the EA. This revision does not impact our Finding of No Significant Impact (FONSI) and is as follows:

In Item 8, on page 7, in the discussion relating to the chelation effects of HEDP, the notifier states, “Although FDA has previously noted that uncertainties intrinsic to its derivation make the usefulness of NOEC/NOEL debatable, the agency has previously indicated that a NOEC for Daphnia magna is an appropriate benchmark for environmental toxicology.” This statement is incorrect and incomplete. FDA did not make the determination that NOEC for Daphnia magna is the appropriate benchmark for environmental toxicology for HEDP. FDA has accepted this endpoint for HEDP based on analysis in the Jaworska, et.al (2002) study cited in the EA. Additionally, as this sentence is written, it could be interpreted more broadly that FDA will accept NOEC as an environmental toxicity endpoint for any substance. Therefore, as the EA already correctly attributes the acceptability of the HEDP toxicity endpoint to the Jaworska, et.al 2002 study, this sentence and the associated footnote shall be disregarded when reviewing this EA.