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Environmental Decision Memo for Food Contact Notification No. 1650

Return to inventory listing: Inventory of Environmental Impact Decisions for Food Contact Substance Notifications or the Inventory of Effective Food Contact Substance Notifications.

See also Environmental Decisions.

Date: July 11, 2016

From: Mariellen Pfeil, Biologist, Division of Biotechnology and GRAS Notice Review (HFS-255)

Subject: FCN No. 1650 – An aqueous mixture containing peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1, 1-diphosphonic acid (CAS Reg. No. 2809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9).

Notifier: Alex C. Fergusson, LLC (AFCO)

To: Thomas Zebovitz, Ph.D., Consumer Safety Officer, Div. of Food Contact Notifications (HFS-275)

Through: Suzanne Hill, Environmental Supervisor, Office of Food Additive Safety (HFS-255)

Attached is the Finding of No Significant Impact (FONSI) for food contact notification (FCN) 1650.

After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment (EA), dated May 18, 2016 may be made available to the public. We will post digital transcriptions of the FONSI and the EA 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.

Mariellen Pfeil


A food-contact notification (FCN No. 1650), submitted by Alex C. Fergusson, LLC (AFCO) 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 wash water used in the production and preparation of shell eggs.

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 May 18, 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 the production and preparation shell eggs at levels not to exceed 2000 ppm peroxyacetic acid (PAA), 800 ppm hydrogen peroxide (HP), and 96 ppm 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP). The FCS is intended for use in egg 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 96 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 partition into 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 77 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 shell egg processing use is 2.0 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 1650.

Prepared by ____________________________________________Date: digitally signed on 07-11-2016
Mariellen Pfeil
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by ____________________________________________Date: digitally signed on 07-11-2016
Suzanne Hill
Environmental Team Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

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