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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001286

 

Date: June 25, 2013
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
 
Subject: FCN No. 1286 – An aqueous mixture of peroxyacetic acid (PAA), hydrogen peroxide, acetic acid, 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP), and water as an antimicrobial agent for use in process water and ice used in the production and preparation of fish and seafood, and pre-formed, carcasses, organs, parts, cuts, and trims of meat and poultry products.
 
Notifier: Mason Chemical Co.
 
To: Thomas 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 1286. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated June 21, 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. 1286     


 

FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1286), submitted by Mason Chemical Co., to provide for the safe use of an aqueous mixture of peroxyacetic acid (PAA), hydrogen peroxide, acetic acid, 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP), and water as an antimicrobial agent for use in process water and ice used in the production and preparation of fish and seafood, and pre-formed, carcasses, organs, parts, cuts, and trims of meat and poultry products..
 
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 June 13, 2013, as summarized below.
 
The FCS will be used as an antimicrobial in the following applications and concentrations:  
Fish & seafood:                       PAA: 179 ppm                         Meat & poultry:                       PAA: 220 ppm
                                                H2O2: 67 ppm                                                              H2O2: 82 ppm
                                                Acetic acid: 625 ppm                                                   Acetic acid: 769 ppm
                              HEDP: 10 ppm                                                                        HEDP: 123 ppm
 
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. HEDP, which is comparatively stable and are expected to persist in the environment, is the primary compound of concern and the focus of the analysis.
 
The highest effective environmental concentration (EEC) for HEDP was estimated as 1 ppm from land-based fish and seafood processing (10 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.[1]
 
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, 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. 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.
 
 
 
Prepared by     __________________________________________Date: June 25, 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 25, 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]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