Environmental Decision Memo for Food Contact Notification No. 1665
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See also Environmental Decisions.
Date: August 5, 2016
From: Biologist, Environmental Team, Division of Biotechnology and GRAS Notice Review (HFS-255)
Subject: Finding of No Significant Impact for Food Contact Notification (FCN) 1665 for chlorine dioxide; CAS Reg. No. 10049-04-4, as an antimicrobial agent used to fumigate fruits and vegetables, including raw agricultural commodities (RAC), in an amount not to exceed 3 ppm residual in the air.
Notifier: Clordisys Solutions, Inc.
To: Elizabeth Furukawa, Ph.D., Division of Food Contact Notifications (HFS-275)
Through: Suzanne Hill, Environmental Supervisor, Office of Food Additive Safety, HFS-255
Attached is the Finding of No Significant Impact (FONSI) for FCN 1665 for chlorine dioxide; CAS Reg. No. 10049-04-4.
After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated July 1, 2016, 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
Finding of No Significant Impact for Food Contact Notification (FCN) 1665 for chlorine dioxide; CAS Reg. No. 10049-04-4, as an antimicrobial agent used to fumigate fruits and vegetables, including raw agricultural commodities (RAC), in an amount not to exceed 3 ppm residual in the air.
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, an environmental impact statement will not prepared. This finding is based on information submitted by the notifier in an environmental assessment, dated July 1, 2016. The EA is incorporated by reference in this Finding of No Significant Impact, and is briefly summarized below. The EA was prepared in accordance with 21 CFR 25.40.
The FCS is intended to be used as an antimicrobial fumigant in closed environments; hence, it is not expected to be released to water resources and impacts to water resources are not discussed in detail in the EA.. The generation of the ClO2 gas will take place in contained, sealed treatment areas such that any releases outside the treatment enclosure would result from unreacted FCS after the treatment process. ClO2 is unstable and any escaped gas is expected to photodegrade to chlorine and oxygen. Therefore, no atmospheric releases of ClO2 are expected from use of the FCS. Chlorite may be expected to form as a degradation product on the surface of food treated with the FCS. It is anticipated that fruits and vegetables that are treated with the FCS may be consumed without a potable water rinse; or they may also be cooked, canned or blanched. Chlorite is expected to decompose during blanching, cooking, or canning. Additionally, any chlorite remaining on fruits and vegetables that are not subject to blanching, cooking, or canning post application of the FCS (i.e. no aqueous rinse step), will be ingested by the consumer. Therefore, we do not expect any environmental releases of chlorite from the proposed use.
Although no ClO2 or its degradate chlorite, is expected to be released, as a worst-case analysis, the expected environmental concentration (EEC) is assumed to be equal to the use concentration of 3 ppm. This concentration can be compared to the LC50 (rat) of 0.29 mg/L for sodium chlorite in EPA’s Reregistration Eligibility Decision (RED) for Chlorine Dioxide and Sodium Chlorite.[1] The notifier assumes the use concentration of 3 ppm is the worst case release concentration, since, realistically, ClO2 gas would be diluted by surrounding air. The acute inhalation toxicity endpoint of 0.29 mg/L converts to 105 ppm, as calculated in the EA, which is much higher than the worst-case EEC of 3 ppm.
Production and use of the FCS is expected to replace existing generation methods; thus, no increase in energy use is expected. Alternatives to the proposed action are not required since no adverse environmental impacts were identified. If the proposed action should not go forward, treatment with chlorine would be the likely alternative.
Therefore, we find that use of the FCS as an antimicrobial fumigant to treat fruits and vegetables, including RAC, in an amount not to exceed 3 ppm residual chlorine dioxide will not cause significant adverse impacts on the human environment. Therefore, an environmental impact statement will not be prepared.
Prepared by __________________________________________Date: digitally signed 08-05-2016
Leah D. Proffitt
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Approved by __________________________________________Date: digitally signed 08-05-2016
Suzanne Hill
Environmental Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
[1] The only inhalation endpoint available in the RED is for sodium chlorite.