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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001363

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: December 5, 2013
 
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
 
Subject: FCN No. 1363 – Mixture of peroxyacetic acid, hydrogen peroxide, acetic acid and l-hydroxyethylidine-1,1-diphosphonic acid (HEDP); (Trade name Peracet 15) as an antimicrobial additive in process water and ice used for meat and poultry.
 
Notifier: Craft Chem, Inc.
 
To: Marla Swain, 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 1363. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated November 18, 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. 1363     

FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1363), submitted by Craft Chem, Inc., to provide for the safe use of a mixture of peroxyacetic acid (PAA), hydrogen peroxide (H2O2), acetic acid and l-hydroxyethylidine-1,1-diphosphonic acid (HEDP); (Trade name Peracet 15) as an antimicrobial additive in process water and ice used for 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 November 18, 2013, as summarized below.
 
The FCS will be used as an antimicrobial in the following applications and concentrations:  
Red meat carcasses, parts, trim & organs: PAA: 220 ppm
H2O2: 80 ppm
HEDP: 13 ppm
 
Whole/cut poultry, parts, trim & organs:PAA: 220 ppm
H2O2: 80 ppm
HEDP: 13 ppm
 
The FCS will be used in closed systems in food processing facilities. Waste water, containing the FCS, degradation products 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 is expected to persist in the environment, is the primary compound of concern and the focus of the analysis.
 
The notifier has inserted an error into the effective environmental concentration (EEC) calculations by using pounds as units and multiplying the HEDP concentration by 1000,000,000 to obtain parts-per-billion:
 
Poultry 1.073 lbs/day HEDP ÷ 8,340,000 lbs/day POTW waste water x 1,000,000,000 = 128.65 ppb
 
We correct the EEC calculation by converting pound/pound to mg/kg is as follows to obtain ppm:
1.073 lbs/day HEDP = 772,468 mg/day HEDP
8,340,000 lbs/day POTW waste water/day = 3,782,960 kg POTW waste water/day
Thus, 772,468 mg/day HEDP ÷ 3,782,960 kg POTW waste water/day = 0.204 mg/kg = ppm
 
The correct meat EEC calculation is as follows:
0.5 lbs/day HEDP = 226,796 mg HEDP/day
8,340,000 lbs/dayPOTW waste water/day = 3,782,960 kg POTW waste water/day
Thus, 226,796 mg HEDP/day ÷ 3,782,960 kg POTW waste water/day = 0.06 mg/kg = ppm
 
Therefore, the highest EEC for HEDP is 0.204 ppm from poultry processing. This amount is three orders of magnitude below Daphnia magna EC50 = 527 ppm.  The EA mistakenly cites a Daphnia magna EC50 of 48 ppm. This appears to be a typographical error where the study duration of 48 hours was listed as the EC50 instead of the EC50 of 527 ppm. The environmental finding of no significant impact remains the same, however.
 
According to a Jaworska et. al. study referenced in the EA, the primary adverse effects of HEDP result from chelation of nutrients rather than direct toxicity of HEDP; thus, the above noted EC50 value reflects nutrient chelation. 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. 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. As shown above, the highest EEC (i.e. that associated with use of the FCS in poultry) is three orders of magnitude below any threshold of concern for the most sensitive endpoint and species and therefore has been determined to provide an adequate margin of safety such that no significant effects are anticipated. 
 
Prepared by     __________________________________________Date: December 5, 2013
Leah D. Proffitt
Biologist
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration
  
Approved by   __________________________________________Date: December 5, 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