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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001284

 

Date: June 19, 2013
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
 
Subject: FCN No. 1284 – An aqueous mixture of peroxyacetic acid, hydrogen peroxide, acetic acid, 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP), water, and optionally, sulfuric acid, used as an antimicrobial to control microorganisms in process water and ice used in the production and preparation of meat, poultry, fish and seafood, and fruits and vegetables.
 
Notifier: Diversey, Inc.
 
To: Anita Chang, PhD., 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 1284. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated May 13, 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
 
cc:       HFS-255 Proffitt
File:    FCN No. 1284     


 

FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1284), submitted by Diversey Inc., to provide for the safe use of an aqueous mixture of peroxyacetic acid, hydrogen peroxide, acetic acid, 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP), water, and optionally, sulfuric acid as an antimicrobial to control microorganisms in process water and ice used in the production and preparation of fish and seafood, meat, and poultry.
 
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 May 13, 2013, as summarized below.
The FCS will be used as an antimicrobial in the following applications and concentrations:  
·         Process water or ice used for washing, rinsing, storing, or cooling whole or cut meat, including carcasses, parts, trim, and organs, at levels not to exceed 400 ppm peroxyacetic acid, 280 ppm hydrogen peroxide, and 20 ppm HEDP;
 
·         Process water, ice, or brine, used for washing rinsing storing or cooling of processed and pre-formed meat as defined in 21 CFR § 170.3(n)(29) and poultry as defined in 21 CFR § 170.3(n)(34), at levels not to exceed 230 ppm peroxyacetic acid, 280 ppm hydrogen peroxide, 12 ppm sulfuric acid, and 14 ppm HEDP;
 
·         Process water applied as a spray, wash, rinse, dip, chiller water, low-temperature (e.g. less than 40 F) immersion baths, or scald water for whole or cut poultry, at levels not to exceed 2000 ppm peroxyacetic acid and 136 ppm HEDP;
 
·         Process water or ice used to commercially prepare fish and seafood, at levels not to exceed 230 ppm peroxyacetic acid, 280 ppm hydrogen peroxide, 12 ppm sulfuric acid, and 14 ppm HEDP, and;
 
·         Process water that contacts fruits and vegetables in a food processing facility, at levels not to exceed 210 ppm peroxyacetic acid, 280 ppm hydrogen peroxide, 12 ppm sulfuric acid, and 10 ppm HEDP.
 
The FCS will be used in closed systems in food processing facilities. 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.  Peroxyacetic acid, hydrogen peroxide, and acetic acid degrade rapidly in contact with organic matter; therefore, they are not expected to survive treatment in POTWs. Therefore, HEDP and sulfate anion (from sulfuric acid), which are comparatively stable and are expected to persist in the environment, are the primary compounds of concern and the focus of the analysis.
 
The environmental introduction concentrations were calculated for HEDP and sulfate for all uses. Sulfate anion is naturally occurring and ubiquitous due to the abundance of sulfur in the environment.[1] Sulfate has been detected at frequencies between 89.9% and 100% in surface and groundwater sites in the EPA National Ambient Water Quality Assessment program (surface water median conc. 20 ppm; 99th percentile 680 ppm).[2] Assuming a dilution factor of 10, the highest EEC for sulfate from the above-described proposed uses of the FCS is 1.26 ppm from meat processing. This amount is below the median and 99th percentile concentrations of sulfate in surface water. Therefore, no significant effects are anticipated.
 
The highest effective environmental concentration (EEC) for HEDP was estimated as 0.68 ppm from poultry (6.8 ppm environmental introduction concentration ÷ dilution factor 10). The final discharge amounts of HEDP from all uses are below the chronic NOEC of 10 ppm for Daphnia magna (see below). This is especially the case when one multiplies these amounts by 0.2 to account for 80-90% adsorption to treatment sludge according to a 2004 HERA study on phosphonates.[3]
 
According to the aforementioned HERA study, 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. Therefore, while lower acute toxicity EC50/LC50 data are available, 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[4] 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. All of the EECs associated with use of the FCS are below any threshold of concern for any species based on the most sensitive endpoint and speciesTherefore, no significant effects are anticipated., in this case, the acute EC50/LC50 values reflect effects from chelation, which is not representative of the current
 
 
 
 
Prepared by     __________________________________________Date: June 19, 2013
Leah D. Proffitt
Biologist
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
 
 
Approved by   __________________________________________Date: June 19, 2013
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]Contaminant Candidate List Regulatory Determination Support Document for Sulfate, USEPA, July 2003, Table 3-1: Abundance of sulfur in different environments: occurrence in freshwater, 5.5 ppm
[2]Contaminant Candidate List Regulatory Determination Support Document for Sulfate, USEPA, July 2003,Table 3-3: Sulfate detections and concentrations in streams and ground water
[3]Human & Environmental Risk Assessment on ingredients of European household cleaning products: Phosphonates; available at http://www.heraproject.com/files/30-F-04-%20HERA%20Phosphonates%20Full%20web%20wd.pdf
[4]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.