? UNITED STATES ENVIRONMENTAL PROTECTION AGENCYWASHINGTON, DC 20460

OFFICE OF CHEMICAL SAFETYAND POLLUTION PREVENTION

February 14. 2012

Paul LorcheimClorDiSys Solutions, Inc.5 Concord RoadLebanon, NJ 08833

Subject: ClorDiSys Sterilization System CSI CD CartridgeEPA Registration Number: 80802-1Letter Date: October 14, 2011EPA Receipt Date: November 16, 2011

Dear Mr. Lorcheim:

The label amendment, submitted in connection with registration under section of the federalInsecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, is acceptable.

Proposed label amendment:

• Add potato storage areas to list of approved use sites on cartridge label• Add Appendix K - illustrating which types of potato spoilage bacteria cartridge is

effective against, and what concentration of chlorine dioxide gas to use - to SystemsOperations Guides for ClorDiSys Sterilization Systems, which contain detailed useinstructions and list of claims against specific potato spoilage organisms.

Should you have any questions or comments concerning this letter, please contact Eliza Blairvia email at blair.eliza(q),epa.sov or by telephone at (703) 308-7279.

A stamped copy the label is enclosed for your record.

Sincerely,

' ' ' v - i ft • '•3msha HarrisIjoduct Manager (32)Regulatory Management Branch IIAntimicrobials Division (751 OP)

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Appendix K.Specialized

Applications

in this appendix. . .

Guidance and cycle development for specializedapplications

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Background and ProcessFundamentalsChlorine dioxide (CD) is a greenish-yellow gas and is a single-electron-transfer oxidizing agent with a chlorine-likeodor. CD has been recognized since the beginning of the century for its disinfecting properties; these propertieshave led to the widespread use of CD in the treatment of drinking water. Beyond this and numerous other aqueousapplications, the sporicidal properties of gaseous CD were demonstrated in 1986. Subsequent to these initialstudies, it has been shown that gaseous CD is a rapid and effective sterilant active against bacteria, yeasts, molds,and viruses. The rapid sterilizing activity of CD is present at ambient temperature and at relatively low gasconcentrations. Chlorine dioxide has also been found to be extremely effective against tuber causing diseasesleading to potato spoilage in storage areas.

Guidance on Development ofSterilization ProcessesTubers:

To control the spread of late blight, soft rot, pink rot, black scurf and other tuber disease causing organism onpotatoes in potato storage areas:

Chlorine dioxide gas for use on tubers going into storage should be utilized at the optimal concentration level of200-400 ppm. The gas can be injected directly into the potato storage area or into the plenum as part of the airstream feeding the storage area.