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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001362

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 30, 2013
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
 
Subject: FCN 1362: An aquatic mixture of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), glycerol (CAS Reg. No. 56-81-5), and optionally acetic acid (CAS Reg. No. 64-19-7) or sulfuric acid (CAS Reg. No. 7664-93-9) for use as an antimicrobial agent on meat, poultry, fish and seafood, and fruits and vegetables that are not raw agricultural commodities.
Notifier: Eltron Research and Development, Inc.
 
To: Paul Honigfort, 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 this Interim Safety Determination. After this becomes effective, copies of this FONSI and the notifier's environmental assessment, dated August 16, 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.
 
 
Talia A. Lindheimer
 
 
 
 
 
 
 
Attachment:         Finding of No Significant Impact
 
File:    FCN 1362
 

 

FINDING OF NO SIGNIFICANT IMPACT
 
A food-contact notification (FCN No. 1362), submitted by Eltron Research and Development, Inc., to provide for the safe use of an aquatic mixture of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), glycerol (CAS Reg. No. 56-81-5), and optionally acetic acid (CAS Reg. No. 64-19-7) or sulfuric acid (CAS Reg. No. 7664-93-9) for use as an antimicrobial agent on meat, poultry, fish and seafood, and fruits and vegetables that are not raw agricultural commodities.
 
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 August 16, 2013, as summarized below.
 
The Food Contact Substance (FCS) will be used as an antimicrobial in meat, poultry, onboard and land-based fish processing, and with fruits and vegetables that are not raw agricultural commodities.  The maximum diluted use levels of the components of the FCS for each individual process are as follows:
 

Table 1: At-Use Concentrations of the FCS
Component
Meat (ppm)
Poultry (ppm)
Fish (ppm)
Fruits and Vegetable (ppm)
PAA
400
1000
190
80
H2O2
280
700
140
60
acetic acid
2500
7000
1220
500
glycerol
360
900
170
80
sodium sulfate/acetate
1300
1300
160
260

 
For each process, a dilution factor (DF) was conservatively applied to the process-specific at-use concentration for each chemical in order to estimate the environmental introduction concentrations (EICs). The EA refers to a DF of 10 was for poultry and fish processing, a DF of 3[1] for meat processing, and a DF of 2 for fruit and vegetable processing. We were unable to confirm that the DF of 2 was representative of current industry practices for fruit and vegetable processing, as these facilities have reduced overall water use. Therefore, we took the conservative step of recalculating the EIC assuming that no dilution occurs (DF=1). The calculations conservatively assume that all of the water (both treated and untreated) that is sent to the POTW will contain the maximum starting concentration of the FCS; as it is assumed that there will be no reduction during food processing nor will there be any degradation of the FCS. Table 2 below provides the environmental introduction concentrations (EICs) each compound at each type of processing facility, including the revised EIC for fruit and vegetable processing.
 

Table 2: EICs for Each Individual Process (ppm)
Component
Meat (ppm)
Poultry (ppm)
Fish (ppm)
Fruits and Vegetable (ppm)
PAA
134
100
19
80
H2O2
94
70
14
60
acetic acid
834
700
120
500
glycerol
120
90
18
80
sodium sulfate/acetate
434
130
61
260

 
 
As PAA and H2O2 are expected to degrade rapidly in the presence of organic materials to oxygen, carbon dioxide and water, these compounds are not expected to survive wastewater treatment.[2] Acetic acid and sodium acetate are not expected to be persistent as these are readily biodegradable and are expected to undergo photodegredation. Glycerol’s low log Kow (-1.76) supports its low sorption to soil and that it is not expected to bioaccumulate. As glycerol is also expected to undergo rapid biodegradation, it is reasonably expected that glycerol will not survive wastewater treatment. Sulfates are a component of the sulfur cycle and are either incorporated into living organisms, reduced to sulfides, deposited as sulfur, or re-oxidized in the atmosphere and oceans. We do not expect that there will be significant introductions of sulfur to the environment since it will undergo treatment at POTWs before discharge and any that survives will be incorporated into the sulfur cycle.
 
For the above reasons, it is reasonable to assume that these compounds will not be present in the effluent of POTWs, and therefore not introduced to the environment.   In the event that the FCS survives wastewater treatment, the environmental fate properties of the FCS support that the notified use is expected to result in little or no introductions of the FCS to the environment, and as a result, we do not expect significant environmental impacts from the use of these compounds.
 
The FCS is intended to be used as a replacement for other PAA disinfectant products on the market. Therefore, no increase in use of resources or energy is expected.
 
No significant environmental impacts have been identified as a result of the use of the FCS, which would otherwise require the preparation of an environmental impact statement.
 
Prepared by     _________________________________________Date: 12/30/2013
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] (450gal/head total discharge water)/(150gal/head process water)]
[2] EPA: Reregistration Eligibility Decision: Peroxy compounds; EPA Case 4072. Doc #738-F-93-026; Dec. 1993. http://www.epa.gov/oppsrrd1/REDs/old_reds/peroxy_compounds.pdf