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Environmental Decision Memo for Food Contact Notification No. 1804

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: October 26, 2017

To: Elizabeth Petro, Ph.D., Division of Food Contact Notifications, HFS-275
Through: Mariellen Pfeil, Acting Environmental Supervisor, Office of Food Additive Safety, HFS-255

From: Biologist, Environmental Team, Division of Biotechnology and GRAS Notice Review, HFS-255

Subject: Finding of No Significant Impact for food-contact notification (FCN) 1804 for chlorine dioxide (CAS Reg. No. 10049-04-4).

Notifier: Selective Micro Technologies, LLC.

Attached is the Finding of No Significant Impact (FONSI) for FCN 1804 for use of Chlorine dioxide, ClO2, (CAS Reg. No. 10049-04-4), as an antimicrobial agent in water used to wash fruits and vegetables that are raw agricultural commodities (RAC). The chlorine dioxide solution will contain at least 90 percent by weight of chlorine dioxide with respect to all chlorine species as determined by Method 4500-ClO2-E.

When used on RAC, the FCS will be applied in the preparing, packing, or holding of food for commercial purposes, consistent with the FD&C Act section 201(q)(1)(B)(i), but not applied for use under 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or (q)(1)(B)(i)(III).

After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment (EA), dated August 8, 2017, may be made available to the public. We will post digital transcriptions of the FONSI and the EA 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. 1804), submitted by Selective Micro Technologies, LLC., to provide for the safe use of chlorine dioxide, ClO2, (CAS Reg. No. 10049-04-4), as an antimicrobial agent in water used to wash fruits and vegetables that are raw agricultural commodities (RAC). The chlorine dioxide solution will contain at least 90 percent by weight of chlorine dioxide with respect to all chlorine species as determined by Method 4500-ClO2-E.

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 be prepared. This finding is based on information submitted by the notifier in an environmental assessment, dated August 8, 2017. 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 agent in water used to wash RAC as defined above. The FCS will be used in an amount not to exceed 3 ppm residual chlorine as determined by Method 4500-ClO2-E. In order to ensure 3 ppm active chlorine, the FCS may be applied at a maximum concentration of 10 ppm. The generation of the ClO2 gas that will be added to water will take place in a microreactor consisting of a semi-permeable-membrane pouch containing starter chemicals. ClO2 is formed upon the addition of a specified volume of water. Spent microreactors are expected to be disposed either to municipal solid waste (MSW) landfills or combustion facilities. Disposal at such permitted facilities is not expected to cause a violation of 40 CFR Parts 258 or 60, respectively. In addition, a greenhouse gas (GHG) analysis provided by the notifier indicates that GHG emissions from combustion of spent microreactors is expected to be far below the 25,000 mT reporting threshold promulgated in 40 CFR 98.2. Waste water from the above-described use will be either discharged ultimately to a publicly-owned treatment works (POTW), or, if in possession of a National Pollutant Discharge Elimination System (NPDES) permit, directly to surface waters after onsite pre-treatment.

Chlorine dioxide undergoes a reduction to chloride, chlorite, and chlorate ions as it is exposed to organic matter; under environmental conditions, ClO2 converts mostly into chlorite ions. The notifier’s effective environmental concentration (EEC) for chlorite (0.0035 ppm) is one degree of magnitude below the lowest ecotoxicity endpoint reported by EPA (EC50 0.027 ppm, Daphnia magna). Similarly, the airborne EEC is assumed to be equal to the use concentration of 10 ppm. The use concentration of 10 ppm is the worst-case air release concentration, since, realistically, ClO2 gas would be diluted by surrounding air. A ClO2 use rate of 10 ppm is equivalent to 0.0276 mg/L ClO2 in the air, which is one degree of magnitude below the acute inhalation endpoint (LC50 rat) of 0.29 mg/L for sodium chlorite.

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 ClO2 generated by other means would be the likely alternative.

Therefore, we find that use of the FCS as an antimicrobial agent to treat fruits and vegetables that are 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 10-26-2017
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 10-30-2017
Mariellen Pfeil
Acting Environmental Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration