Environmental Decision Memo for Food Contact Notification No. 001247

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Date: February 13, 2013
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)

Subject: FCN No. 1247 – An aqueous mixture of peroxyacetic acid, hydrogen peroxide, acetic acid, l-hydroxyethylidine-1,1-diphosphonic acid, and water as an antimicrobial to control microorganisms in process water and ice used in the production and preparation of fish and seafood, meat, and poultry.
Notifier: Valley Chemical Solutions

To: Kenneth McAdams, 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 1247. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated January 31, 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


A food-contact notification (FCN No. 1247), submitted by Valley Chemical Solutions to provide for the safe use of a mixture of peroxyacetic acid, hydrogen peroxide, acetic acid, 1-hydroxyethylidene-1,1- diphosphonic acid (HEDP), and water, 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 January 31, 2013 as summarized below.

Peroxyacetic acid, hydrogen peroxide, and acetic acid degrade rapidly in contact with organic matter; therefore, the compound of environmental concern is HEDP, which is comparatively stable and is expected to persist in the environment.

The final discharge amounts of HEDP from meat, poultry and fish operations to surrounding water bodies were multiplied by 0.8 in the EA. This is not appropriate. The notifier’s intent was to account for 80-90% adsorption to treatment sludge according to a HERA 2004 study on phosphonates. Based on that assumption, 20% of the HEDP is discharged into surrounding water bodies. Thus, the EEC’s for HEDP were recalculated using a 0.2 multiplier and are estimated at 0.3 ppm (meat), 130 ppb (poultry), and 0.2 ppm (seafood). While the notifier references an EEC of 4.64 ppm calculated by FDA for FCN 691, this value estimates introductions as a result of use in the commercial sterilization of polyethylene terephthalate and high density polyethylene food packaging. As such it was not considered in the evaluation of the environmental impact of the proposed use in this FCN.

The notifier cites data from the aforementioned HERA study demonstrating that the toxic 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[1] 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 10 ppm chronic NOEC for Daphnia magna., in this case, the acute EC50/LC50 values reflect effects from chelation, which is not representative of the current

Prepared by     __________________________________________Date: February 13, 2013
Leah D. Proffitt
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by   __________________________________________Date: February 13, 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] 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.

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