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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001384

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: November 13, 2013
 
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
 
Subject: FCN No. 1384 – An aqueous mixture of peroxyacetic acid (PAA), hydrogen peroxide (H2O2), sodium hydroxide, and glycerine as an antimicrobial in process water or ice used in processing meat, poultry, and fruits and vegetables.
 
Notifier: Enviro Tech Chemical Services, Inc.
 
To: Vanee Komolprasert. P.E., 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 1326. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated September 4, 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. 1326
FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1384), submitted by Enviro Tech Chemical Services, Inc., to provide for the safe use of an aqueous mixture of peroxyacetic acid (PAA), hydrogen peroxide (H2O2), sodium hydroxide, and glycerine, as an antimicrobial agent for use in process water and ice used in the production meat, poultry, 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 September 4, 2013, as summarized below.
 
The FCS will be used as an antimicrobial in the following applications and concentrations:
Meat: PAA 400 ppm, H2O2 100 ppm
Poultry: PAA 2000 ppm, H2O2 500 ppm in post-chiller water.  PAA 1000 ppm, H2O2 250 ppm for all other uses
Fruits and Vegetables: PAA 300 ppm, H2O2 75 ppm
 
The FCS is prepared on site (within 1 minute) by adding sodium hydroxide to triacetin and hydrogen peroxide.   Therefore no stabilizers are required, allowing the FCS to be used immediately upon generation, and at higher concentrations. Specifically, the FCS is generated from a PAA precursor (45 wt.% triacetin and 55 wt.% of 50% H2O2) and sodium hydroxide (NaOH). The reaction converts triacetin to PAA at an 87% efficiency level and also yields H2O2, glycerine and residual triacetin (13%).
 
Poultry
The FCS will be used in sprays and the finishing chiller bath of a poultry plant. As stated in the EA, the daily treated water amount to process 250,000 birds is 150,000 gal, and a total water use rate of 1,717,500 gallons per day is expected (6.87 gal/bird x 250,000 birds). In dividing the total daily water amount by the treated amount, a dilution factor of 11.45 is obtained.
 
Meat
Using water-use data from U.S. EPA, and meat processing rates from USDA-NASS and N.C. Department of Environment and Natural Resources, an annual processing amount of 35 million head of beef, at 1,300 lbs each. The numbers of large (66), small (214), and 5% of very small facilities (519 x 0.05 = 26) were added to estimate a representative number of slaughter facilities (306). Dividing the total head per year (35 million) by the number of facilities (306) yields 114,379 head of cattle per facility per year, which equals 519 head/day based on 220 working days per year. An estimated total water use to be 500 gal/head, including 150 gal/head treated process water. Given the daily amount of 519 head/day, total treated water use is 77,850 gal/day. An in-house study of the decay rate of PAA and H2O2 was conducted, compared with dibromodimethylhydantoin (DBDMH) and HOBr, and it was concluded the EEC for both will be 0 ppm, as follows:
 
“To determine the estimated percentage degradation associated with PAA and H2O2 in a meat carcass wash, a study on the persistency of bromine residuals on carcass surfaces with treatments of DBDMH and HOBr is referenced. After bovine are slaughtered, the skin is removed from the carcass and then the carcass is cut in half exposing a layer of adipose tissue. In this study, 220ppm as PAA from Perasan MP-2 was applied to sections of adipose tissue to compare results against the use of DBDMH and HOBr. The 220ppm peracetic acid applied to the adipose tissue had a high recovery at 1 minute time, but degraded before 5 minutes without any recovery of PAA. Due to the fact that rapid degradation occurs on the surfaces of beef adipose tissue within 5 minutes of contact, the EIC for PAA for 1 hour following contact with beef surfaces would be 0 ppm. To determine the percentage of degradation that would occur for H2O2 on a meat carcass wash, we will estimate that the degradation of H2O2 on beef will be similar to poultry due to the organic challenge posed by lipids and adipose tissue. Therefore EIC of H2O2 on a meat carcass wash would be 0 ppm.”
 
The same degradation rates are expected to occur with poultry such that the EIC for PAA and H2O2 used in poultry processing are also expected to be 0 ppm.
 
Fruits and Vegetables
The FCS will be used as a spray, in dip tanks, wash tanks, and brush washers in fruit and vegetable processing facilities. These facilities, unlike most meat and poultry processors, recycle much of their water in flumes or dip tanks.
 
Based on industry estimates and notifier experience, a mean of 1000 gal of wastewater is assumed to be generated per ton of product, and approximately 10% make-up water is assumed to be added to recycled volume per shift. Spray operations use low-flow technology, and, thus, constitute a minor water use.
 
A study of the persistence of PAA and H2O2 residuals on the surfaces of treated fruits and vegetables is referenced. Persistence of PAA and H2O2 was longest on apples at 180 minutes and 240 minutes respectively, so the values from the apple experiment were used to calculate EIC and EEC. The EIC is calculated for 1 hour to be conservative based on persistence of PAA and H2O2 on apples as follows:
 
350ppm PAA x 10% compound remaining (ppm) = 35ppm PAA EIC (EEC = 3.5 ppm)
87.5ppm H2O2 x 60% compound remaining (ppm) = 52.5ppm H2O2 EIC (EEC = 5.25 ppm)
 
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 publicly owned treatment works (POTW), 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. Glycerine and triacetin are, comparatively, more stable and are the focus of the analysis of potential impacts on the environment.
 
According to a study of glycerol (glycerine) sponsored by the Organisation for Economic Cooperation and Development (OECD), 100% of the substance will partition to the water phase, with negligible amounts distributed in soil, air and sediment. Furthermore, it was concluded that glycerol is readily biodegradable at 92% in 30 days, and over 60% in 10 days.[1] The OECD study states that “the weight of evidence indicates that glycerol is of low toxicity to aquatic organisms and this conclusion is supported by QSAR predictions.” With respect to chronic toxicity, the reports states “No long-term aquatic toxicity data is available. Screening studies are available on frog and carp embryos which indicate some effects on growth and hatching rates respectively at very high concentrations of glycerol, >7000 mg/l. However, their ecological relevance is not clear.” OECD’s finding is that glycerol is of low hazard potential. Glycerine for the proposed use is Generally Recognized as Safe and, therefore, no new environmental introduction is anticipated as a result of the proposed use.
 
A U.S. Army Public Health Command study of wildlife toxicity of triacetin concludes that, due to its high water solubility and low vapor pressure, 99% of the compound is expected to hydrolyze rapidly to glycerol and acetic acid, which degrade further to CO2.[2]
Therefore, no significant environmental impacts are anticipated from the proposed use and disposal of the FCS.
 
Prepared by       __________________________________________Date: November 13, 2013
Leah D. Proffitt
Biologist
Office of Food Additive Safety  
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
Approved by      __________________________________________Date: November 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] OECD SIDS Initial Assessment Report for SIAM 14; Glycerol, March 2002; available at http://www.inchem.org/documents/sids/sids/56815.pdf
[2] U.S. Army Public Health Command Public Health Notice, May 2012, Wildlife Toxicity Assessment for Triacetin; Available at http://phc.amedd.army.mil/PHC%20Resource%20Library/WTA_%20Triacetin.pdf