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Date: April 30, 2017
From: Mariellen Pfeil, Biologist / Acting Lead, Environmental Review Team, Division of Biotechnology & GRAS Notice Review / Office of Food Additive Safety, HFS-255
Subject: Finding of No Significant Impact for Food Contact Notification (FCN) 1745 – 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) and 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP; CAS Reg. No. 2809-21-4) for use as an antimicrobial agent in process water used in the production of meat and poultry.
Notifier: Ecolab, Inc.
To: Elizabeth S. Furukawa, Ph.D., Consumer Safety Officer, Div. of Food Contact Notifications, Office of Food Additive Safety, HFS-275
Attached is the Finding of No Significant Impact (FONSI) food contact notification (FCN) 1745.
After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated Jan. 30, 2017, may be made available to the public. We will post digital transcriptions of the FONSI and the environmental assessment on the agency's public website.
Please let us know if there is any change in the identity or use of the food-contact substance.
Attachment: Finding of No Significant Impact
FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1745), submitted by Ecolab, Inc. to provide for the safe use of an aqueous mixture of peroxyacetic acid, hydrogen peroxide, acetic acid and 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) for use as an antimicrobial agent in process water used in the production of meat and poultry.
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 January 30, 2017 (with a 4/30/2017 FDA annotation). 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 used in the production of meat and poultry. The components of the FCS will not exceed 2000 ppm peroxyacetic acid, 1474 ppm hydrogen peroxide, and 118 ppm 1-hydroxyethylidene-1,1-diphosphonic acid in spray, wash, rinse, dip, chill, and scald water for whole or cut and poultry or meat including carcasses, parts, trim and organs. The FCS is intended for use in meat and poultry 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 118 ppm. 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.
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 94.4 ppm, therefore there is no toxicity expected from land application of sludge that contains HEDP as a result of the use of the FCS.
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 or poultry 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 meat and poultry is not expected to have a significant environmental impact; therefore, an environmental impact statement will not be prepared for FCN 1745.
Prepared by __________________________________________Date: digitally signed 04-30-2017
Biologist / Acting Lead
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration