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Date: November 4, 2016

From: Physical Scientist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS‐255)

Subject: Finding of No Significant Impact for FCN No. 1713 – 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 (CAS Reg. No. 2809‐21‐4)

Notifier: Brainerd Chemical Company

To: Vanee Komolprasert Ph.D., Division of Food Contact Notifications (HFS‐275)
Through: Suzanne Hill, Environmental Team Supervisor, Office of Food Additive Safety, HFS 255

Attached is the Finding of No Significant Impact (FONSI) for FCN 1713.

After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated September 27, 2016, 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.

Antonetta Thompson‐Wood

Attachment: Finding of No Significant Impact

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FINDING OF NO SIGNIFICANT IMPACT

A food‐contact notification (FCN No. 1713), submitted by Brainerd Chemical Company to provide for the safe use of 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 (CAS Reg. No. 2809‐21‐4), as an antimicrobial agent in process water and ice used in the production and preparation of whole or cut poultry and meat.

The Office of Food Additive Safety has determined that allowing food contact notification (FCN) 1713 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 environmental assessment (EA), dated September 27, 2016, as summarized below. 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 and ice used in the production and preparation of whole or cut poultry and meat. When used as intended, the components of the FCS mixture will not exceed:

1. 2000 ppm peroxyacetic acid (PAA), 750 ppm hydrogen peroxide (HP), and 136 ppm 1‐ hydroxyethylidine‐ 1,1‐diphosphonic acid (HEDP) in spray, wash, rinse, dip, chiller water, low temperature (e.g., less than 40°F) immersion baths, or scald water for whole or cut poultry carcasses, parts, trim, and organs; and
2. 1800 ppm PAA, 675 ppm HP, and 33 ppm HEDP in process water or ice used for washing, rinsing, or cooling whole or cut meat, including carcasses, parts, trim, and organs.

The antimicrobial agent is intended for use in meat and poultry processing plants and packaging facilities throughout the United States.

The antimicrobial agent is needed to reduce or eliminate pathogenic and non‐pathogenic microorganisms that may be present on the food or in the process water or ice used during production.

Introduction of Substances into the Environment as a Result of Use

The waste process water containing the FCS is expected to be disposed of through the processing plant’s onsite wastewater treatment facility before discharge either to surface waters under National Pollution Discharge Elimination System (NPDES) permitting or to a publicly owned treatment works (POTW).

Treatment of the process water at an on‐site wastewater treatment plant or POTW is expected to result in complete degradation of PAA, hydrogen peroxide, and acetic acid. Specifically, the 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 onsite treatment facility or POTW. As such, the environmental impacts of these substances are not expected to be introduced into the environment to any significant extent as a result of the proposed use of the FCS. Therefore, the EA focuses on the environmental impacts of HEDP.

As large‐scale facilities do not typically process more than one type of animal, the calculated environmental introduction concentration (EIC) of HEDP for poultry (i.e., 136 ppm) was determined to be the worst‐case concentration for all meat and poultry facilities using the FCS. 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]). The maximum EEC in sludge is 108.8 ppm, therefore the FCS is not expected to have any terrestrial environmental toxicity concerns at levels at which it is expected to be present in sludge or soil.

Aquatic Ecotoxicity

The lowest relevant HEDP endpoint for aquatic toxicity was determined to be the chronic NOEC of 10 ppm for Daphnia magna. The conservatively estimated EEC of 2.7 ppm is 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

Use of the FCS will not require additional energy resources for treatment and disposal of waste solution, as the components readily degrade. The raw materials that are used in production of the mixture are commercially‐manufactured materials that are produced for use in a variety of chemical reactions and production processes. Energy used specifically for the production of the mixture components is not significant.

Alternatives to the Proposed Action

No potential adverse environmental effects were identified in the EA that would necessitate alternative actions for the proposed use in this Food Contact Notification. 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 have no environmental impact. The addition of the antimicrobial agent to the options available to food processers is not expected to increase the use of peroxyacetic acid antimicrobial products.

As evaluated in the EA, the proposed use of the FCS as an antimicrobial agent in process water and ice used in the production and preparation of whole or cut poultry and meat, as described in FCN 1713, is not expected to have a significant environmental impact; therefore, an environmental impact statement will not be prepared.

Prepared by __________________________________________Date: Digitally signed 11-09-2016
Antonetta Thompson‐Wood
Physical Scientist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: Digitally signed 11-04-2016
Suzanne Hill
Environmental Team Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration