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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001400

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:
February 7, 2014
 
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
 
Subject: FCN No. 1400 – Chlorine dioxide, as an antimicrobial agent in water used in poultry processing and to wash fruits and vegetables that are not raw agricultural commodities, in an amount not to exceed 3 ppm residual chlorine dioxide.
 
Notifier: Clordisys Solutions, Inc.
 
To: Elizabeth Furukawa, Ph.D., Division of Food Contact Notifications (HFS-275)
Through: Mariellen Pfeil, Environmental Reviewer, Office of Food Additive Safety, HFS-255____
 
Attached is the Finding of No Significant Impact (FONSI) for FCN 1400. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated November 27, 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 

FINDING OF NO SIGNIFICANT IMPACT
 
A food-contact notification (FCN No. 1400), submitted by Clordisys Solutions, Inc., to provide for the safe use of chlorine dioxide (ClO2) as an antimicrobial agent in water used in poultry processing and to wash fruits and vegetables that are not raw agricultural commodities, in an amount not to exceed 3 ppm residual chlorine dioxide.
 
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 in an environmental assessment, dated November 27, 2013 as summarized below.
 
The requested action is for the safe use of chlorine dioxide, generated by the reaction between chlorine gas and a solid matrix of sodium chlorite (“Gas:Solid process”[1]), for use as an antimicrobial agent in water used to process poultry and wash fruits and vegetables that are not raw agricultural commodities in an amount not to exceed 3 ppm. The amount of solution or gas fed to maintain this level will be dependent on the microbiological and organic demand of the water. It is estimated that application rates will be in the range of 4 ppm to 10 ppm. Assuming a maximum application rate of 10 ppm, ClO2 is converted to chlorite and chlorate in a 70:30 ratio, such that:
 
The maximum concentration of chlorite in waste water is 7 ppm (10 ppm x 0.7 = 7 ppm), and
The maximum concentration of chlorate in waste water is 3 ppm (10 ppm x 0.3 = 3 ppm).
 
Waste water will be either pre-treated onsite (i.e. poultry facilities)[2] and further processed at a Publically-Owned Treatment Works (POTW), or simply treated at a POTW (i.e. fruit and vegetable facilities).
 
In calculating the effective environmental concentration (EEC), it is assumed that 50% of total wastewater discharge is treated with the FCS, the receiving stream dilution factor is 10, and chlorite removal via wastewater treatment is 99%
 
EEC for chlorite: 7 ppm * 0.5 * (1-0.99) * (1/10) = 0.0035 ppm
EEC for chlorate: 3 ppm * 0.5 * (1/10) = 0.15 ppm
 
Comparison of these EECs with the LC50 for Daphnia magna shows that the EEC for chlorite (0.0035 ppm) is one order of magnitude below the lower bound of the LC50 range (0.027 - 0.39 ppm), and almost 4 orders of magnitude below the LC50 for chlorate (920 ppm).
 
Any incidental air releases will not exceed 0.03 ppm, and are expected to undergo photodecomposition, as described in EPA’s Final Risk Assessment for Chlorine Dioxide, Case 4023. The air EEC of 0.03 ppm is compared with the LC50 for rats (0.29 mg/L), and is shown to be equivalent to 105 ppm as shown below:
 
(0.29 mg/L) x (24.45 L/mole)* x (1 mole/6.75 g) x (1000 μg/mg) = 105 ppm (μg/g)
*24.45 = volume (liters) of a mole (gram molecular weight) of a gas at 1 atmosphere and at 25°C.
67.5 = molecular weight of ClO2
 
Thus, the air EEC of 0.03 is 4 orders of magnitude lower than the LC50 for rats; therefore we agree that no significant impacts are expected from air releases of ClO2 as a result of the proposed use.
 
Prepared by __________________________________________Date: see electronic signature
Leah D. Proffitt
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
Approved by __________________________________________Date: see electronic signature
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] US Patent No. 6,824,756 B2, Rosenblatt et al., “Process for manufacturing and using a more stable formulation of sodium chlorite,” Nov. 30, 2004
[2] Pursuant to 40 CFR Part 432, Meat and Poultry Processors are subject to industry sector-specific, technology-based standards that are commonly called "Effluent Guidelines and [Pretreatment or Categorical] Standards."