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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001389

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: January 15, 2014
 
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
 
Subject: FCN No. 1389 – A mixture containing peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1, 1-diphosphonic acid (CAS Reg. No. 2809-21-4), water (CAS Reg. No 7732-18-5) and optionally sulfuric acid (CAS Reg. No. 7664-93-9), for use as an antimicrobial agent as described below. 
 
Notifier: Alex C. Fergusson, LLC
 
To: Kelly Randolph, D.V.M, M.P.H, Division of Food Contact Notifications (HFS-275)
Through:  Annette M. McCarthy, Ph.D, Senior Science and Policy Staff____
 
The FCS is notified to be used as an antimicrobial agent in:
 
(1) 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 carcasses, parts, trim, and organs;
 
(2) Process water or ice used for washing, rinsing, storing, or cooling whole or cut meat, including carcasses, parts, trim, and organs;
 
(3) 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);
 
(4) Process water or ice used during commercial preparation of fish and seafood; and
 
(5) Process water for washing or chilling fruits and vegetables in food processing facilities.
 
Attached is the Finding of No Significant Impact (FONSI) for FCN 1389. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated January 7, 2014, 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.
 
Talia A. Lindheimer
 
Attachment: Finding of No Significant Impact
File: FCN No. 1389
FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1389), submitted by Alex C. Fergusson, LLC to provide for the safe use of a mixture containing peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1, 1-diphosphonic acid (CAS Reg. No. 2809-21-4), water (CAS Reg. No 7732-18-5) and optionally sulfuric acid (CAS Reg. No. 7664-93-9), for use as an antimicrobial to control microorganisms in process water and ice used in the production and preparation of poultry, meat, pre-formed meat and poultry products, fish and seafood, and fruits and vegetables.
 
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 7, 2014 as summarized below.
 
Peroxyacetic acid, hydrogen peroxide, and acetic acid degrade rapidly in contact with organic matter and are not expected to survive wastewater treatment, nor enter the environment in significant concentrations. The compound of environmental concern is HEDP, which is comparatively stable and is expected to persist in the environment. The Environmental Introduction Concentrations (EICs) for HEDP were estimated for the use of the FCS in processing operations for meat, poultry, fish, processed and preformed meat and/or poultry and fruit and vegetables.  To estimate these EICs for each process, process-specific maximum diluted concentration were used alongside process-specific assumptions.
 
When the FCS is used in meat processing facilities, it was assumed that the wash water (i.e., water that contains the FCS) is used at a rate of 660 gal/min[1]in a large meat processing facility, and that a large plant is estimated to process approximately 5,000 heads/daily (EIC = 4.81 ppm[2].The EA also cites data from the National Agricultural Service, and states that 490 heads may be processed daily at a facility. The rate of 490 heads/day was not used in evaluating the potential environmental impacts of the proposed action as it does not represent standard industry practices at large facilities.
 
When the FCS is used on poultry carcasses, the manner in which it is used and the prescribed use level are both consistent with what is expected for Campylobacter and Salmonella treatments[3] it was not considered in the evaluation of the environmental impacts of this proposed use.. A standard dilution factor of 10 was applied to the maximum concentration of HEDP to estimate the EIC to be 9.6 ppm. In the EA, a dilution factor of 20 is also described, although supporting information was not provided to show that this value is reflective of current industry practices. As this value was not used in the calculation of the EICs and is not supported;
 
The FCS will also be used in processed and preformed meat and/or poultry facilities as well as for seafood processing. A DF of 10 was applied to the maximum diluted concentration of HEDP to estimate the maximum EIC for HEDP at 1.1 ppm for both of these processes. When the FCS is used aboard fishing vessels during the initial evisceration and cleaning of fresh-caught seafood, it is expected that any wastewater from the onboard process will be discharged into the ocean. Therefore an estimation of the EIC for HEDP is deemed insignificant for this use as the solution is expected to be rapidly dispersed in the ocean.
 
A potable water rinse is not required when this FCS is used on fruits and vegetables. As such, a dilution factor was not used since it is assumed that all of the water used in a fruit and vegetable processing plant is treated with the FCS and subsequently discharged. This results in a calculated EIC for HEDP of 4 ppm.
 
In summary, the calculated EICs are below:

Use
HEDP
EIC
Whole or cut meat, including carcasses, parts, trim, and organs
19 ppm
4.8 ppm
Whole or cut poultry carcasses, parts, trim, and organs
96 ppm
9.6 ppm
Processed and pre-formed meat and poultry products
11 ppm
1.1 ppm
Fish and seafood (not including on boat use)
11 ppm
1.1 ppm
Fruits and Vegetables
4 ppm
4 ppm

 
To assess the environmental risk to HEDP for the notified use of the FCS, the highest calculated EIC (poultry processing) was used to estimate a worst-case Expected Environmental Concentration (EEC) of 0.96 ppm. The Human and Environmental Risk Assessment Project (HERA)[4] report was used to assess the potential terestiral impacts of HEDP. The report indicates that HEDP is not toxic to soil-dwelling organisms at levels below 1000 mg/kg soil (1000 ppm). 
 
To assess the aquatic toxicity of HEDP, the ecotoxicity endpoints available in J. Jaworska et. Al were considered.[5]  This study itself contends that the lower toxicity endpoints that were reported (such as those for Selenastrum capricornutm) are attributable to the chelation effect of HEDP, and the associated depletion of nutrients, not to an intrinsic toxic effect.  However, due to the high nutrient environment of treatment sludge, this chelation effect is not deemed relevant.  Rather, eutrophication is the main effect of concern relating to wastewater discharges from food processing plants. Therefore, to assess aquatic risk, the maximum EEC of 0.96 ppm associated with the use of the FCS was compared to the 96-hr LC50 of 3 ppm for Selenastrum capricornutum. 
 
Land application/disposal of treatment sludge is not expected to result in environmental toxicity. Furthermore, no toxic effects from HEDP are expected in the aquatic compartment of the environment.   No extraordinary circumstances have been identified, which would otherwise indicate a significant environmental impact, as a result of the use of the FCS.
 
Prepared by       __________________________________________Date:
Talia A. Lindheimer
Biologist
Office of Food Additive Safety  
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
Approved by      __________________________________________Date:
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] (hide-on washers – 300 gpm; hide-off carcass washer – 170 gpm; head washers – 50 gpm; pre-evisceration cabinets – 70 gpm; and, hot washers – 70 gpm

[2] (19 μg HEDP/g wash water)(454 g wash water/lb)(8.3 lb/gal wash water)(660 gal wash water/min) ÷ (5000 head/960 min)(500 gal total water/head)(8.3 lb/gal)(454 g total water/lb) = 4.81 μg HEDP/g total water effluent.

 
 

[3] See USDA FSIS Federal Register Notice, “New Performance Standards for Salmonella and Campylobacter in Young Chicken and Turkey Slaughter Establishments: Response to Comments and Announcement of Implementation Schedule,” 76 Fed. Reg. 15282; see also FSIS Notice 54-12, “New Performance Standards for Salmonella and Campylobacter in Chilled Carcasses at Young Chicken and Turkey Slaughter Establishments,” dated 9/11/12, available at http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/54-12.pdf.

 
 

[4] Human and Environmental Risk Assessment (HERA) on ingredients of European Household Cleaning Products: Phosphonates (2004). Available at http://www.heraproject.com/files/30-F-04-%20HERA%20Phosphonates%20Full%20web%20wd.pdf

 
 

[5] Jaworska, J.; Van Genderen-Takken, H.; Hanstveit, A.; van de Plassche, E.; Feijtel, T. Environmental risk assessment of phosphonates, used in domestic laundry and cleaning agents in the Netherlands. Chemosphere 2002, 47, 655-665.