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Date: March 23, 2016

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

Subject: FCN No. 1641 – 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 (HEDP) (CAS Reg. No. 2809-21-4), dipicolinic acid (CAS Reg. No. 499-83-2), and sodium hydroxide (CAS Reg. No. 1310-73-2); as an antimicrobial agent in: (1) process water applied as a 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) process water, ice, or brine used for washing, rinsing, or cooling of processed and preformed meat as defined in 21 CFR 170.3(n)(29) and poultry as defined in 21 CFR 170.3(n)(34).

Notifier: Solvay Chemicals, Inc.

To: Marla D. Swain, Division 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) 1641. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated February 10, 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.

Leah D. Proffitt

Attachment: Finding of No Significant Impact

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FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1641), submitted by Solvay Chemicals, Inc., to provide for the safe use of 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 (HEDP) (CAS Reg. No. 2809-21-4), dipicolinic acid (CAS Reg. No. 499-83-2), and sodium hydroxide (CAS Reg. No. 1310-73-2); as an antimicrobial agent in: (1) process water applied as a 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) process water, ice, or brine used for washing, rinsing, or cooling of processed and preformed meat as defined in 21 CFR 170.3(n)(29) and poultry as defined in 21 CFR 170.3(n)(34).

The Office of Food Additive Safety has determined that allowing this notification 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, dated February 10, 2016, as summarized below.

The FCS is intended to inhibit the growth of undesirable or pathogenic microorganisms, and will be used as a wash in food processing throughout the United States, as follows:

1. In process water applied as a 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. The components of the food-contact substance mixture will not exceed: 2000 ppm peroxyacetic acid, 933 ppm hydrogen peroxide, 120 ppm 1-hydroxyethylidene-1, 1-diphosphonic acid (HEDP) and 0.5 ppm dipicolinic acid (DPA) in spray, wash, rinse, dip, chiller water, low-temperature (e.g., less than 40°F) immersion baths, scald water for whole or cut poultry carcasses, parts, trim, skin on or off, and organs;
2. Process water, ice, or brine used for washing, rinsing, or cooling of processed and preformed meat as defined in 21 CFR 170.3(n)(29) and poultry as defined in 21 CFR 170.3(n)(34). The components of the food-contact substance mixture will not exceed: 230 ppm peroxyacetic acid, 107 ppm hydrogen peroxide, 14 ppm 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) and 0.1 ppm dipicolinic acid in process water, ice, or brine used for washing, rinsing, or cooling of processed and preformed meat as defined in 21 CFR 170.3(n)(29) and poultry as defined in 21 CFR 170.3(n)(34).

Disposal will be via onsite wastewater treatment ultimately to a publicly-owned treatment works (POTW), or, if in possession of a National Pollutant Discharge Elimination System (NPDES) permit, directly to surface waters. Analysis of impacts is based on the worst case/highest use level, i.e., poultry at 2000 ppm PAA, 933 ppm H2O2, 0.5 ppm DPA, and 120 ppm HEDP.

As the peroxygen compounds (PAA, H2O2) are expected to degrade rapidly in the presence of organic matter, and acetic acid and sulfuric acid readily dissociate in the environment, the components of environmental concern are DPA and the phosphonate HEDP. HEDP adsorbs at 80% to wastewater treatment sludge, and 20% to the aquatic environment. Therefore, the expected environmental concentration (EEC) for HEDP is as follows:

EECwater = 2.4 ppm
EECsludge = 96 ppm

Pursuant to papers by Jaworska et. al. and HERA (referenced in footnotes 15 and 16 in the EA), HEDP shows no toxicity to terrestrial organisms at levels up to 1000 mg/kg soil dry weight (No Observed Effect Concentration; NOEC), and the lowest relevant endpoint for aquatic toxicity was determined to be the chronic NOEC of 10 ppm for Daphnia magna. Therefore, there is no toxicity expected from land application of sludge containing 96 ppm HEDP or discharge of effluent containing 2.4 ppm HEDP.

DPA does not exhibit any partitioning behavior; thus, the EEC is assumed to be the use concentration of 0.5 ppm diluted 10-fold to 0.05 ppm.

USEPA’s ECOSAR (Ecological Structure Activity Relationships) estimates for DPA yield the following endpoints for fish (LC50 = 322 mg/L), freshwater invertebrates (LC50 = 89 mg/L for the Daphnid) and algae (EC50 = 111 mg/L for green algae). The EEC for DPA is 0.05 ppm. This value is >1000-fold lower than the predicted toxicity values for DPA. Therefore, the aquatic risks for the intended uses of DPA are expected to be negligible.

Therefore, the proposed use of the FCS as an antimicrobial solution in (1) process water applied as a 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) process water, ice, or brine used for washing, rinsing, or cooling of processed and preformed meat does not present significant adverse environmental impacts.

Prepared by __________________________________________Date: digitally signed 03-23-2016
Leah D. Proffitt
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: digitally signed 03-25-2016
Suzanne Hill
Environmental Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration