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Environmental Decision Memo for Food Contact Notification No. 1823

Environmental Decision Memo for Food Contact Notification No. 1823

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: November 21, 2017

To: Marla Swain, Ph.D., Division of Food Contact Notifications (HFS-275)
Through: Mariellen Pfeil, Acting Environmental Supervisor, 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) 1823 for an aqueous solution of peroxyacetic acid (PAA; CAS Reg. No. 79-21-0), hydrogen peroxide (HP; CAS Reg. No. 7722-84-1), acetic acid (AA; CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP; CAS Reg. No. 2809-21-4), and dipicolinic acid (DPA; CAS Reg. No. 499-83-2), as an antimicrobial agent in the production and preparation of whole or cut poultry and meat, fruits and vegetables, and processed/pre-formed meat and poultry.

Notifier: Brainerd Chemical Co.

Attached is the Finding of No Significant Impact (FONSI) for FCN 1823 for use of an aqueous solution of peroxyacetic acid (PAA; CAS Reg. No. 79-21-0), hydrogen peroxide (HP; CAS Reg. No. 7722-84-1), acetic acid (AA; CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP; CAS Reg. No. 2809-21-4), and dipicolinic acid (DPA; CAS Reg. No. 499-83-2), as an antimicrobial agent in the production and preparation of whole or cut poultry and meat, fruits and vegetables, and processed/pre-formed meat and poultry.

After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment (EA), dated October 16, 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. 1823), submitted by Brainerd Chemical Co., to provide for the safe use of an aqueous solution of peroxyacetic acid (PAA; CAS Reg. No. 79-21-0), hydrogen peroxide (HP; CAS Reg. No. 7722-84-1), acetic acid (AA; CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP; CAS Reg. No. 2809-21-4), and dipicolinic acid (DPA; CAS Reg. No. 499-83-2), as an antimicrobial agent in the production and preparation of whole or cut poultry and meat, fruits and vegetables, and processed/pre-formed meat and poultry, as described 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 be prepared. This finding is based on information submitted by the notifier in an environmental assessment, dated October 16, 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. 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 proposed uses are as follows: 

 Use  PAA ppm HP ppm HEDP ppm  DPA ppm 
 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  2000 1474  14  0.88 
 Process water or ice used for washing, rinsing, or cooling whole or cut meat, including carcasses, parts, trim, and organs  1800  1215  12  0.5
 Water for washing or chilling fruits and vegetables in food processing facilities  350  1000  10  0.25
 Water, brine, or ice used for washing, rinsing, or cooling processed and pre‐formed poultry  230  186  14  0.1
 Water, brine, or ice used for washing, rinsing, or cooling processed and pre‐formed meat  495  355  14  0.1

The peroxygen components of the FCS (PAA, HP) and acetic acid are expected to degrade rapidly in the presence of organic material. Thus, the components of environmental concern are the stabilizers HEDP—a chemically stable phosphonate—and DPA. As a conservative, worst-case approach, the analysis of environmental impacts is based on the highest use concentrations (i.e. in whole or cut poultry) of 14 ppm HEDP and 0.88 ppm DPA.

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 14 ppm HEDP yields an effective environmental concentration (EEC) in sludge of 14 ppm x 0.8 = 11.2 ppm. The aquatic environmental introduction concentration (EIC) is 14 ppm z 2.8 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 2.8 ppm ÷ 10 = 0.28 ppm. For DPA, which is soluble in water and does not partition to sludge, it is assumed that the EIC is equal to the use concentration (0.88 ppm). Therefore, the EEC is 0.088 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 11.2 ppm HEDP. Similarly, discharge to surface waters of effluent containing 0.28 ppm HEDP is not expected to have toxic effects.

There is little information available on DPA itself, so environmental toxicity was assessed using EPA’s ECOSAR program, which estimates effects based on structure-activity relationships and predictions from similar chemical classes. The lowest toxicity endpoints, according to ECOSAR, are a chronic value of 29 mg/L for fish (proxy: pyridine-alpha-acid), and a chronic value of 89 mg/L (proxy: neutral organic SAR). The expected worst-case EEC of 0.088 ppm is 3 orders of magnitude below these concentrations.

Use of the FCS in is not expected to result in a net increase in the use of energy and resources, because the raw materials used in the manufacture of the FCS are already in wide use in other industrial applications.

No significant environmental impacts are expected from use and disposal of the FCS; therefore, mitigation measures have not been identified. The alternative of not allowing the FCN to become effective would be the continued use of the materials that the subject FCS would otherwise replace; such action would have no environmental impact.

Consequently, we find that use of the FCS as an antimicrobial agent in the production and preparation of whole or cut poultry and meat, fruits and vegetables, and processed/pre-formed meat and poultry, as described in FCN 1823, will not cause significant adverse impacts on the human environment. Therefore, an environmental impact statement will not be prepared.

Prepared by __________________________________________Date: digitally signed 11-21-2017
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 11-21-2017

Mariellen Pfeil
Acting Environmental Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration