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Environmental Decision Memo for Food Contact Notification No. 1693

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: September 12, 2016

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

Subject: Finding of No Significant Impact for Food Contact Notification (FCN) 1693 for an aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (H2O2) (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), optional sulfuric acid (CAS Reg. No. 7664-93-9) and 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4)

Notifier/Petitioner: Aquagenics Technologies, Inc.

To: Vivian Gilliam, 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 FCN 1693 for 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), optional sulfuric acid (CAS Reg. No. 7664-93-9) and 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4).
After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated August 11, 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


FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1693), submitted by Aquagenics Technologies, Inc., Inc., to provide for the safe use of an aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (H2O2) (CAS Reg. No. 7722-84-1), acetic acid (AA) (CAS Reg. No. 64-19-7), optional sulfuric acid (SA) (CAS Reg. No. 7664-93-9) and 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4); as an antimicrobial agent as specified below.

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, an environmental impact statement will not prepared. This finding is based on information submitted by the notifier in an environmental assessment, dated August 11, 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 subject food-contact substance (FCS) will be used as an antimicrobial agent in the control of microorganisms commonly encountered in food processing and production in the following applications and concentrations:

  1. process water or ice, used for washing, rinsing, or cooling whole or cut meat, including carcasses, parts, trim and organs at concentrations not to exceed 400 ppm PAA, 100 ppm hydrogen peroxide, and 5 ppm HEDP;
  2. process water applied as 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 at concentrations not to exceed 2000 ppm PAA, 500 ppm hydrogen peroxide, and 27 ppm HEDP;
  3. process water or ice used for washing, rinsing, or cooling of processed and preformed meat and poultry (as defined in 21 CFR 170.3(n)(29) and 21 CFR 170.3(n)(34), respectively) at concentrations not to exceed 230 ppm PAA, 57 ppm hydrogen peroxide, and 3 ppm HEDP;
  4. process water or ice used to commercially prepare fish and seafood at concentrations not to exceed 230 ppm PAA, 57 ppm hydrogen peroxide, and 3 ppm HEDP; and
  5. process water that contacts fruits and vegetables in a processing facility at concentrations not to exceed 350 ppm PPA, 88 ppm hydrogen peroxide, and 5 ppm HEDP.

Waste water from the above-described uses will be either discharged 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 after onsite pre-treatment.

The peroxygen components of the FCS (PAA, H2O2) are expected to degrade rapidly in the presence of organic material. Acetic acid readily biodegrades, and sulfuric acid dissociates in the presence of water. Thus, the chemically stable phoshonate HEDP is the component of environmental concern. HEDP is a chelating agent and exhibits unique partitioning behavior such that 80% adsorbs to wastewater treatment sludge, while the remaining 20% stays in the water. With the exception of the use profile associated with the processing of poultry carcasses (number 2 above), all HEDP use levels are below the aquatic ecotoxicity endpoint of 10 ppm. Therefore, the analysis of environmental impacts focuses on the HEDP concentration used in poultry carcasses, i.e. 27 ppm. Applying the 80:20 partitioning factors yields an environmental introduction concentration (EIC) in sludge of 27 ppm x 0.8 = 21.6 ppm and an EIC of 5.4 ppm in water. In order to arrive at the effective environmental concentration (EEC) in water, a 10-fold dilution factor is applied to the HEDP that remains in water to account for dilution upon release to surface water: EIC ÷ 10 = 0.54 ppm.

HEDP shows no toxicity to terrestrial organisms at levels up to 1000 mg/kg soil dry weight (Eisenia foetida, 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 21.6 ppm HEDP or discharge to surface waters of effluent containing 0.54 ppm HEDP. No air releases are expected; therefore, the air component was not analyzed in detail in the EA.

Use of the FCS is not expected to cause a significant impact on resources or energy. The FCS is made in a PAA manufacturing facility with existing fixed costs that would not be increased in a significant way by the manufacture of this FCS. The ingredients used in the manufacture of the FCS are purchased in bulk quantities for several other products already manufactured by the notifier, and this FCS would not pose a significant additional burden on those requirements.

No mitigation measures are needed since no significant adverse impacts are expected from use of the FCS. The alternative of not approving the FCN would be cross-contamination from re-use of marinades.

As evaluated in the EA, the use of the FCS as an antimicrobial agent in food processing will not significantly affect the human environment, and, therefore an environmental impact statement will not be prepared.

Prepared by __________________________________________Date: digitally signed 09-12-2016
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 09-12-2016
Suzanne Hill
Environmental Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration