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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001379

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: January 15, 2014
 
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
 
Subject: FCN No. 1379 – An aqueous solution of peroxyacetic acid (PAA), hydrogen peroxide (H2O2), acetic acid, and 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) as an antimicrobial agent to treat process water or ice as a spray, wash, rinse, dip, chiller water, or scald water for whole or cut poultry including parts, trim, and organs.
 
Notifier: Synergy Technologies
 
To: Tom Zebovitz Ph.D., Division of Food Contact Notifications (HFS-275)
Through: Annette M. McCarthy, Ph.D, Senior Science and Policy Staff____
 
Attached is the Finding of No Significant Impact (FONSI) for FCN 1379. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated December 20, 2013, 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
File: FCN No. 1379
FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1379), submitted by Synergy Technologies, to provide for the safe use of an aqueous solution of peroxyacetic acid (PAA), hydrogen peroxide  (H2O2), acetic acid, and 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) as an antimicrobial agent to treat process water or ice as a spray, wash, rinse, dip, chiller water, or scald water for whole or cut poultry including parts, trim, and organs.
 
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 December 20, 2013, as summarized below.
 
The FCS is intended to inhibit the growth of undesirable or pathogenic microorganisms in process water and ice used to prepare whole or cut poultry including parts, trim, and organs, and will be used at the following concentrations:               
PAA:      2000 ppm
H2O2:     728 ppm
HEDP:    13.3 ppm
 
The FCS will be used in closed systems in poultry processing facilities. Following on-site pre-treatment, waste water, containing the FCS and all process and cleaning water from the facilities, is expected to be discharged to publicly owned treatment works (POTW) before ultimately being discharged into the environment. PAA and H2O2 degrade rapidly in contact with organic matter; therefore, they are not expected to survive treatment in POTWs. HEDP, which is comparatively stable and is expected to persist in the environment, is the primary compound of concern and the focus of the analysis.
 
The FCS concentrate will be diluted on site to the proposed use concentrations noted above. Maximum component concentration in the undiluted product is as follows:
PAA = 15.3%
H2O2 = 5.5%
Acetic acid = 42%
HEDP = 0.10% (1000 ppm)
 
It is estimated that 250,000 poultry carcasses are processed per day, with each carcass using 8 gal of water for a total of 1.25 million gal per day, of which 36.2 gal are concentrated FCS. As shown below in the calculations below, this results in an HEDP environmental introduction concentration (EIC) of 32 ppb. Applying a 10-fold dilution factor yields an effective environmental concentration (EEC) of 3.2 ppb for HEDP.
 
Given the percent breakdown of FCS components, the 36.2 gal of concentrate weighs 333 lbs or 151.2 kg, such that:
PAA = 15.3% of 151.2 kg = 23.1 kg
H2O2 = 5.5% of 151.2 kg = 8.3 kg
Acetic acid = 42% of 151.2 kg = 63.5 kg
HEDP = 0.10% of 151.2 kg = 0.151 kg
 
Assuming that 100% of these components is discharged in the 1.25 million gallons (= 4.74 mill L) effluent to a POTWs yields the following EICs:
PAA = 23,100 g/4.74 mill L = 4,873 g/1 mill L = 4.87 mg/L = ppm
H2O2 = 8,300 g/4.74 mill L = 1,751 g/1 mill L = 1.75 mg/L* = ppm
Acetic acid = 63,500g/4.74 mill L = 13,396 g/ 1 mill L = 13.4 mg/L* = ppm
HEDP = 151 g/4.74 mill L = 31.9 g/1 mill L = 0.032 mg/L = 32 ppb (÷10 = 3.2 ppb EIC)
 
*The EA mistakenly states 1.75 g/L = ppm, and 13.4 g/L = ppm
 
According to a Jaworska et. al. study, referenced in the EA, that reflects the agency’s current understanding of HEDP, the primary adverse effects of HEDP result from chelation of nutrients rather than direct toxicity of HEDP. Chelation is not toxicologically relevant in the current evaluation because eutrophication, not nutrient depletion, has been demonstrated to be the controlling toxicological mode when evaluating wastewater discharges from food processing facilities. The lowest short-term LC50 values published for Selenastrum capricornutm (3 ppm), Daphnia magna (165 ppm), and Crassostrea virginica (89 ppm) are acute toxicity endpoints considered to result from this chelation effect. These values are not relevant when excess nutrients are present as expected in food processing wastewaters. The lowest relevant endpoint for food processing uses was determined by Jaworska et al. in the HERA study to be the chronic NOEC of 10 ppm for Daphnia magna. Although the uncertainties intrinsic to its derivation make the usefulness of the NOEC/NOEL debatable, even to the point that it has been recommended that they be abandoned and replaced by other statistics such as EC50/LC50 [1], in this case, the acute EC50/LC50 values reflect effects from chelation, which is not representative of the current high-nutrient situation where eutrophication and not nutrient depletion is the primary concern. Therefore, while NOEC values are not ideal, they were used to evaluate the environmental impact as they are the only relevant toxicity values currently available. The EEC of 3.2 ppb is 2 orders of magnitude lower than the 10 ppm chronic NOEC for Daphnia magna. Thus no significant environmental impacts are anticipated from the proposed use and disposal of the FCS.
 
Prepared by       __________________________________________Date: January 15, 2014
Leah D. Proffitt
Biologist
Office of Food Additive Safety  
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
Approved by      __________________________________________Date: January 15, 2014
Annette M. McCarthy, Ph.D.
Senior Science and Policy Staff
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration


[1] Blok, J. and F. Balk, 1995. "Environmental Regulation in the European Community," in Fundamentals of Aquatic Toxicology: Effects, Environmental Fate, and Risk Assessment, (GM Rand, Ed.), Taylor & Francis, New York, 1995, chapter 27. NOEC determinations are likely more statistically variant (uncertain) than EC50 determinations.