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Environmental Decision Memo for Food Contact Notification No. 1799

Environmental Decision Memo for Food Contact Notification No. 1799

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: August 14, 2017

To: Anita Chang, Ph.D., Division of Food Contact Notifications (HFS-275)
Through: Mariellen Pfeil, Acting Environmental Team Lead, Office of Food Additive Safety, HFS-255

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

Subject: Finding of No Significant Impact for food-contact notification (FCN) 1799 for an aqueous mixture of peroxyacetic acid (PAA; CAS Reg. No. 79-21-0), hydrogen peroxide (HP; CAS Reg. No. 7722-84- 1), acetic acid (AA; CAS Ref. No. 64-19-7), hydroxyethylidene 1,1-diphosphonic acid (HEDP; CAS Reg. No. 2809-21-4), and optionally, sulfuric acid (SA; CAS Reg. No. 7664-93-9). Trade name "Oxysan."

Notifier: Biosan, LLC

Attached is the Finding of No Significant Impact (FONSI) for FCN 1799, request for use of an aqueous mixture of peroxyacetic acid (PAA), hydrogen peroxide (HP), acetic acid (AA), hydroxyethylidene 1,1-diphosphonic acid (HEDP), and optionally, sulfuric acid (SA), as an antimicrobial in food processing facilities.

After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment (EA), dated June 20, 2017, 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.

Leah D. Proffitt

Attachment: Finding of No Significant Impact


FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1799), submitted by Biosan, LLC., to provide for safe use of use of an aqueous mixture of peroxyacetic acid (PAA), hydrogen peroxide (HP), acetic acid (AA), hydroxyethylidene 1,1-diphosphonic acid (HEDP), and optionally, sulfuric acid (SA), as an antimicrobial in food processing facilities as described below.

The Office of Food Additive Safety has determined that allowing this FCN to become effective will not significantly affect the quality of the human environment and, therefore, an environmental impact statement will not be prepared. This finding is based on information submitted by the submitter in an environmental assessment, dated June 20, 2017. 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 food-contact substance (FCS) is intended to inhibit the growth of undesirable or pathogenic microorganisms, and will be used in food processing facilities throughout the United States, as well as in open water, on-board fish processing. 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. In the case of on-board fish processing, effluent will be released directly to the open ocean. The proposed uses are as follows:

  1. Process water or ice used during commercial preparation of fish and seafood at 230 ppm PAA, 110 ppm HP, and 15 ppm HEDP;
  2. Brines, sauces, and marinades to be applied on the surface or injected info processed or unprocessed, cooked or uncooked whole or cut poultry at 50 ppm PAA, 18 ppm HP, and 6 ppm HEDP; and,
  3. Surface sauces and marinades applied on processed and preformed meat and poultry products as described in 21 CFR 170.(n)(29) and (34) at 50 ppm PAA, 18 ppm HP, and 6 ppm HEDP.

The peroxygen components of the FCS (PAA, HP) are expected to degrade rapidly in the presence of organic material. Sulfuric acid dissociates in the presence of water. Sodium acetate, which is a reaction by-product, is not highly toxic to aquatic organisms, dissociates into hydrogen proton and acetate anion, which readily biodegrades in activated treatment sludge. Thus, the chemically stable phosphonate HEDP is the component of environmental concern. As a conservative, worst-case approach, the analysis of environmental impacts is based on the highest use concentration (i.e. in fish and seafood; item i above) of 15 ppm HEDP.

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. Applying the 80:20 partitioning factors to the above-described worst-case concentration of 15 ppm HEDP yields an effective environmental concentration (EEC) in sludge of 15 ppm x 0.8 = 12 ppm. The aquatic environmental introduction concentration (EIC) is 15 ppm x 0.2 = 3 ppm. In order to arrive at the 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 = EEC). Therefore, the aquatic EEC is 3 ppm ÷ 10 = 0.3 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 12 ppm HEDP. Similarly, discharge to surface waters of effluent containing 0.3 ppm HEDP is not expected to have toxic effects.

Use of the FCS is not expected to cause a significant impact on resources or energy. 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 significant environmental impact.

As evaluated in the EA, the use of the FCS as described in FCN 1799 is not expected to significantly affect the human environment, and, therefore an environmental impact statement will not be prepared.

Prepared by __________________________________________Date: digitally signed 08-14-2017
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 08-14-2017
Mariellen Pfeil
Acting Environmental Team Lead
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration