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Environmental Decision Memo for Food Contact Notification No. 1715

Environmental Decision Memo for Food Contact Notification No. 1715

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: December 22, 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) 1715 for an aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (H2O2) (CAS Reg. No. 7722-84-1), and 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4)

Notifier: Seeler Industries, Inc.

To: Ken McAdams, Ph.D., 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 1717 for an aqueous mixture of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), 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 October 21, 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. 1715), submitted by Seeler Industries, 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), and 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), as an antimicrobial agent in process water or ice used in the processing of meat, poultry, fish and seafood, shell eggs, fruit and vegetables.

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 (EA), dated October 21, 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 process water or ice used in the processing of meat, poultry, fish and seafood, shell eggs, fruit and vegetables:

  1. 2000 parts per million (ppm) PAA, 773 ppm HP, and 118 ppm 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 or in water for washing shell eggs.
  2. 460 ppm PAA, 177 ppm HP, and 27 ppm HEDP in spray, wash, rinse, dip, chiller water, or scald water for meat carcasses, parts, trim, and organs.
  3. 495 ppm PAA, 190 ppm HP, and 29 ppm HEDP in process water or ice for washing, rinsing, or cooling of processed and pre-formed meat products.
  4. 230 ppm PAA, 88 ppm HP, and 14 ppm HEDP in water or ice used for washing, rinsing, or cooling processed and pre-formed poultry products or in the commercial preparation of fish and seafood.
  5. 350 ppm PAA, 135 ppm HP, and 21 ppm HEDP in water or ice for washing or chilling fruits and vegetables in food processing facilities.

Waste water from the above-described use will be either discharged 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. Thus, the chemically stable phosphonate 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. The analysis of environmental impacts focuses on the highest HEDP use concentration, i.e. 118 ppm in poultry processing and shell egg processing (see 1. above). Applying the 80:20 partitioning factors yields an environmental introduction concentration (EIC) in sludge of 118 ppm x 0.8 = 94.4 ppm and an EIC of 118 ppm x 0.2 = 23.6 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 = 2.4 ppm EEC.

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 94.4 ppm HEDP or discharge to surface waters of effluent containing 2.4 ppm HEDP. No air releases are expected; therefore, impacts to air resources were 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 expected to compete with, and to some extent replace, similar antimicrobial agents already on the market. No mitigation measures are needed since no significant adverse impacts are expected from use of the FCS. The alternative to not allowing the FCN to become effective would be continued use of currently approved antimicrobial agents; such action would have no environmental impact.

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

Prepared by __________________________________________Date: digitally signed 12-22-2016
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 12-23-2016
Suzanne Hill
Environmental Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration