Food

Environmental Decision Memo for Food Contact Notification No. 1419

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

Subject: FCN No. 1419 – An aqueous mixture of peroxyacetic acid, hydrogen peroxide, acetic acid, sulfuric acid, and 1-hydroxyethylidine-1,1-diphosphonic acid. The FCS will be used as an antimicrobial additive in process water (processing aid) for poultry products such as:

  1. Post-main chiller (air or water) secondary processing of whole birds, parts and pieces, skin on or off and organs, in the washing, rinsing, cooling and processing of poultry products; and,
  2. Use in pre-air chiller dip tanks and post-main water chiller systems as finishing chillers

Notifier: Enviro Tech Chemical Services, Inc.

To: Vivian Gilliam, Division of Food Contact Notifications (HFS-275)
Through: Leah Proffitt, Environmental Reviewer, Office of Food Additive Safety, HFS-255____

Attached is the Finding of No Significant Impact (FONSI) for FCN 1419. 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.

Mariellen Pfeil

Attachment: Finding of No Significant Impact


FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1419), submitted by Enviro Tech Chemical Services, Inc., to provide for the safe use of an aqueous mixture of peroxyacetic acid (PAA), hydrogen peroxide (H2O2), acetic acid, sulfuric acid, and 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) as an antimicrobial additive in process water (processing aid) for 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 (EA), dated December 20, 2013, as summarized below.

The FCS is intended to be used as a spray or dip application to control microbial growth in process water (processing aid) for poultry products including:

  1. Post-main chiller (air or water) secondary processing of whole birds, parts and pieces, skin on or off and organs, in the washing, rinsing, cooling and processing of poultry products and;
  2. Use in pre-air chiller dip tanks and post-main water chiller systems such as finishing chillers.

The FCS would be intermittently or continuously introduced to the wash water and be limited to a maximum dose of 2,000 ppm as PAA, 770 ppm as H2O2, and 100 ppm as HEDP.

Used as above, the predominant type of discharge would be to an on-site wastewater treatment plant that would discharge to a publicly-owned treatment works (POTW). Treatment of the FCS in this method represents a >99% degradation of the PAA, H2O2, acetic acid and sulfuric acid into the degradation products carbon dioxide, water, oxygen, acetic acid and sulfate.(1,2,3) Further, decay profile data in the EA showed over 90% PAA degradation on contact with chicken halves over a period of 1 hour with greater than 99% degradation after 3 hours and that all of the detectable H2O2 degraded after just 10 minutes.(4)

Given these assumptions the Environmental Introduction Concentrations (EICs) for PAA, H2O2, and HEDP are 200, 0, and 100 ppm, respectively.(5)

As stated in the EA, the daily treated water amount to process 250,000 birds is 163,200 gal, and a total water use rate of 1,717,759 gallons per day is expected (26 L/bird ÷ 3.784 L/gal x 250,000 birds/day). In dividing the total daily water amount by the treated amount, a dilution factor of 10.53 is obtained. Therefore the Estimated Environmental Concentrations (EECs) for PAA, H2O2, and HEDP are 19.0, 0, and 9.5 ppm, respectively.

Waste water containing the FCS, and all process and cleaning water from the facilities for all proposed uses, is expected to be pre-treated at on-site treatment facilities before being discharged to POTWs, and, ultimately, to the environment. The peroxygen compounds (PAA, H2O2) degrade rapidly in contact with organic matter, as described previously. Therefore, they are not expected to survive on-site pre-treatment or treatment in POTWs. HEDP is, comparatively, more stable and is the focus of the analysis of potential impacts on the environment.

The EA cites the Human and Environmental Risk Assessment Project (HERA) to support that the treatment steps at a POTW will remove or decompose at least a portion of any HEDP that remains.(6) The HERA study cites 90% adsorption of HEDP to sewage treatment sludge, and 94% breakdown of HEDP in low ortho-phosphate environments by phosphonate-degrading bacteria in soil or activated sludge. Using what we expect to be the worst-case HEDP EEC, of 9.5 ppm, we have estimated that the amount of HEDP in water discharged from POTWs will be 0.96 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.(7) 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 capricornutum (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, 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 0.96 ppm is approximately 1 order of magnitude lower than the 10 ppm chronic NOEC for Daphnia magna.

Therefore, no significant environmental impacts are anticipated from the proposed use and disposal of the FCS.

Prepared by__________________________________________
Mariellen Pfeil
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by__________________________________________
Robert I. Merker, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration


1 U.S. EPA: Reregistration Eligibility Decision: Peroxy compounds; Case 4072, Doc #EPA-738-F-93-026; Dec. 1993., p. 16, www.epa.gov-REDs-Peroxy_compounds.
2 ECETOC: European Centre for Ecotoxicology and Toxicology of Chemicals, JACC No. 040, "Peracetic Acid and its Equilibrium Solutions"; January 2001
3 ECETOC: European Centre for Ecotoxicology and Toxicology of Chemicals, JACC No. 022, "Hydrogen Peroxide"; January 1993
4 Attachment #7 of the current notification: "The Decay Profile of PAA (2000 ppm) and H2O2 on Poultry", Dec. 2013
5 EIC = use level x % compound remaining after treatment
6 HERA – Human & Environmental Risk Assessment on Ingredients of European Household Cleaning Products: Phosphonates. 06/09/2004. www.heraproject.com - Phosphonatesdisclaimer icon
7 Jaworska, J., H. Van Genderen-Takken, A. Hanstveit, e. van de Plassche, and T. Feijtel. Chemosphere 47:655-665. 2006.

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