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Date: December 10, 2013
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
Subject: FCN No. 1370 – Chlorine dioxide, ClO2 [CAS Reg. No. 10049-04-4] to be used as an antimicrobial agent to wash fruits and vegetables that are not raw agricultural commodities. A potable water rinse will no longer be required for those fruits and vegetables that are not further processed by blanching, cooking or canning.
Notifier: CDG Environmental, LLC
To: Hui Chen Chang, 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 1370. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated October 10, 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.
Attachment: Finding of No Significant Impact
File: FCN No. 1370
FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1370), submitted by CDG Environmental, LLC, to provide for the safe use of Chlorine dioxide, ClO2 [CAS Reg. No. 10049-04-4], intended be used as an antimicrobial agent to wash fruits and vegetables that are not raw agricultural commodities. A potable water rinse will no longer be required for those fruits and vegetables that are not further processed by blanching, cooking or canning.
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 October 10, 2013.
Description of the Proposed Action:
The food contact substance (FCS) is intended for use in an amount not to exceed 3 ppm residual chlorine dioxide. The FCS is not authorized for any usage in the processing or packaging of infant food formula or its ingredients, or in the holding and feeding of infant food, (food for infants 0-6 months of age).
This FCN modifies the use of the FCS, as currently authorized under FCN 1011, to remove the requirement for a potable water rinse for fruits and vegetables that are not further processed by blanching, cooking or canning. The removal of the potable water rinse is not expected to result in any significant increase in the use of chlorine dioxide but instead reflects changes in industry practices which reduce the amount of water used in processing.
Introduction of Substances into the Environment:
No environmental release is expected in the manufacture of the FCS. There are no extraordinary circumstances indicative of any adverse environmental impact resulting from manufacture of the FCS and any discharges are in compliance with regulations pertaining to publicly operated treatment works (POTW) operation.
Uses of the FCS generated by the proposed method are identical and substitutive for uses of the FCS by already approved methods. There are no new or significantly different chemical releases resulting from the use of the FCS. Further, the FCS will be reduced by organic matter and microorganisms on or in the food, in process water, or in subsequent wastewater treatment to chlorite (ClO2-), chlorate (ClO3- ), and ultimately to chloride (Cl-) ions. The expected route of disposal for process water from these facilities is via discharge to on-site wastewater treatment systems or into POTWs.
Aquatic release. In the event that chlorite and chlorate ions are present in wastewater, estimated potential environmental introduction concentrations (EICs) and subsequent expected environmental concentrations (EECs) are calculated using the following assumptions:
- Maximum application rate is 10 ppm, which is needed to obtain an at use concentration of 3 ppm
- Chlorine dioxide is completely converted to chlorite and chlorate in a 70/30 ratio
- No chlorite impurity in the FCS
- Average 75% of total plant water is used for processing,
- Approx. 50% of processing water is ClO2 treated,
- Processing plants can achieve an estimated 25% reduction in treated process water by various steps, including elimination of potable water rinsing,
- Chlorite removal/destruction by wastewater treatment at the food processing plant is 99% 
- Dilution factor of 10 into the receiving stream
From this, for every 100 gallons of total plant water effluent, 75 are used for processing when a potable water rinse is included (0.75 x 100 gal = 75 gal processing water), with 37.5 of those gallons being treated with ClO2 (0.50 x 75 gal = 37.5 gal ClO2 treated processing water) and the remaining 37.5 of those gallons being non-ClO2 treated processing water. The final 25 gallons of total plant effluent are non-processing water emissions.
The notifier states in the EA, ‘Processing plants can achieve estimated 25% reduction of treated process water by various steps, including elimination of potable water rinsing’. The removal of a potable water rinse would not reduce the amount of treated process water as a potable water rinse does not contain the regulated antimicrobial. There are two possible interpretations for possible sources of water reduction used to calculate environmental introductions from this statement. In both scenarios the volume of ClO2 treated processing water and the non-processing water remain constant (i.e., 37.5 gal and 25 gal, respectively).
The first, calculates the water reduction as 25% of the 37.5 non-ClO2 treated processing water yielding a total plant effluent of 37.5 gal ClO2 treated processing water + (37.5 gal non-ClO2 treated processing water - 0.25 x 37.5 gal non-ClO2 treated processing water = 28.125 gal) + 25 gal non-processing water = 90.625 gal total plant water effluent.
The second calculates the water reduction as 25% of all processing water yielding a total plant effluent of 37.5 gal ClO2 treated processing water + (37.5 gal non-ClO2 treated processing water - 0.25 x 75 gal all processing water = 18.75 gal) + 25 gal non-processing water = 81.25 gal total plant water effluent. As this represents a more conservative estimation of environmental dilution of FCS residues, this interpretation was utilized for EIC and EEC calculations and replaces those provided in the EA.
Therefore, the calculated EIC for chlorite prior to elimination of potable water rinsing is 10 ppm ClO2 x 0.70 ClO2 to chlorite conversion x 37.5 gal ClO2 treated processing water ÷ 100 gal total plant effluent water x (1 - 0.99 chlorite destruction) = 0.02625 ppm chlorite.
The EIC for chlorite following elimination of potable water rinsing is calculated as 10 ppm ClO2 x 0.70 ClO2 to chlorite conversion x 37.5 gal ClO2 treated processing water ÷ 81.25 gal total plant effluent water x (1 - 0.99 chlorite destruction) = 0.03231 ppm chlorite.
The EICs for chlorate prior to and following elimination of potable water rinsing are calculated similarly. EECs are calculated using the 10-fold dilution factor. EIC and EEC data are summarized in Table 1.
|Compound||EIC (w/ rinse)
|EIC (w/o rinse)
|EEC (w/ rinse)
|EEC (w/o rinse)
Airborne release. Any off-gassed chlorine dioxide is expected to be negligible and readily decomposed by organic exposure or photochemical decomposition.
Terrestrial release. No adverse environmental effects are expected from the terrestrial release of water from fruit and vegetable processing used in irrigation of agronomic crops following on-site primary treatment.
Environmental Effects of Released Substances:
U.S. EPA aquatic toxicity endpoints for chlorite and chlorate are presented in EA Tables 3 and 4 , respectively. The calculated risk quotient (RQ) (EEC / lowest toxicity endpoint) estimates of the environmental risk for both chlorite and chlorate are given in Table 2.
|a freshwater invertebrates
b aquatic plants – green algae
|Compound||EEC (w/ rinse)
|EEC (w/o rinse)
|Chlorate||0.112500||0.138462||133 b||< 0.001||< 0.001|
The RQ’s calculated for chlorite and chlorate are below or slightly above the target level of concern for all species, RQ = 0.1. While the RQ for chlorite exceeds the target RQ, it does so in a minimal way and given the ambiguity of the notifier’s assumption relating to the water use reduction calculation, deference to the more conservative calculation, and the use of rough calculations rather than accurate measurements, it is unlikely from this evaluation that the proposed action will result in significant environmental impacts.
Use of Resources and Energy:
Production of the FCS will replace existing methods of chlorine dioxide generation, and is not expected to result in increased use of natural resources. Overall, the manufacture of the FCS, its application, and use are all expected to use less energy than the already existing methods of chlorine dioxide generation. Additionally, resource savings will be seen by the reductions of water usage and in the volume of wastewater generated.
Alternative Actions / Mitigation:
No potential adverse environmental effects have been identified which would necessitate mitigation measures or alternative actions to that proposed.
In conclusion, no significant environmental impacts are anticipated from the proposed use and disposal of the FCS.
Prepared by __________________________________________Date: ____________
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
 Werdefhoff, K.S. and P.C. Singer. Chlorine Dioxide Effects on THMpp, TOXFP, and the formation of Inorganic By-Products. Journal AWWA, Sept. 1987.div>
 Details of Industrial Water Use and Potential Savings by Sector: Appendix F. Preserved Fruits and Vegetables (SIC 203), http://www.pacinst.org/wp-content/uploads/2013/02/appendix_f3.pdf
 Water Saving Factsheet: Process Fruit and Vegetable Industry, Environment Report 2005, Australian Food and Grocery Council, 2006. http://pdf.aigroup.asn.au/environment/7082_WPA_fact_sheet FRUIT.pdf
 United States-Asia Environmental Partnership; Civil Engineering Research Foundation, Clean Technologies in US Industries: Focus on Food Processing.
 Fruit and Vegetable Processing, Food Processing Environmental Assistance Center, Purdue University, West Lafayette, IN. http://www.fpeac.org/fruit/cornflowchart.html
 Fruit and Vegetable Processing—Reducing Water and Wastewater Costs, Accepta, Advanced Environmental Technologies, 2013.
 Overview of Chlorine Dioxide (CIO2), Howard Alliger, August 2001.</div> <div>http://www.grandcircuitinc.com/sites/default/files/Howard Alliger-An_Overall_View_Cl02.pdf
Toxicological Profile for Chlorine Dioxide and Chlorite, Agency for Toxic Substances and Disease Registry, http://www.atsdr.cdc.gov/toxprofiles/tp160.pdf
 FDA letter to Gary Burin, Technology Sciences Group, Inc. dated September 25, 2013
 This ambiguity was discovered after acceptance of the EA. It was decided that the worst-case interpretation would be utilized to evaluate environmental introductions of possible FCS residues.
 Specific to EA Table 4, 7.3 mg/L is, numerically, the lowest chlorate LC50. However, upon reviewing the EPA risk assessment that provides this value for chlorate, all reported aquatic toxicity LC50’s are >1000 mg/L with a single exception. As stated in the risk assessment, “Woodiwiss et al. (1974) (summarized in Appendix L) reported a 48-hour LC50 of 7.3 mg/L in brown trout for chlorate, which indicates that brown trout could be considerably more sensitive to chlorate than other fish species. No other studies in brown trout were located, and sufficient information was not available in the publication to allow for an evaluation of data quality.” The uncertainty EPA has with the dependability of this value of 7.3 mg/L deems it inappropriate to use as the lowest toxicity value for risk comparison. The next lowest aquatic toxicity value identified by EPA is 133 mg/L. This is reported in the chlorate risk assessment as an EC50 derived from a core 96-hour study in green algae. Therefore FDA agrees with the notifier’s use of 133 mg/l as the endpoint to use for chlorate.