2_JA 2120320 Sterimist.docx

Justification for Other than Full and Open Competition at or Below the Simplified Acquisition Threshold

Project Title: TOMI Sterimist Ionized Hydrogen Peroxide System

I. Identification of the agency and contracting activity

II. Description of the project, and supplies or services required to meet the agency’s needs A. Project Background The requested product is a Sterimist ionized hydrogen peroxide (iHP) system manufactured by TOMI. This system is used to decontaminate laboratory spaces and equipment within the space and to do so leaving very little mess and with the ability to vent the rooms directly outdoors once the decontamination process is complete.

The current process that we use to decontaminate our BSL-4 laboratories uses formaldehyde gas followed by an ammonium bicarbonate gas to neutralize the formaldehyde prior to venting outside. This process leaves a noxious powdery residue on all surfaces which is very difficult to clean and is detrimental to electronic equipment. The IRF currently has several complex imaging and immunological equipment that are both very expensive and difficult to clean. In addition, we are purchasing new imaging equipment that is not compatible with formaldehyde gas decontamination. The intent in purchasing the Sterimist system is to safely decontaminate our laboratory spaces while reducing the health risk to laboratory personnel and decreasing the potential damage to expensive equipment caused by our current formaldehyde decontamination process.

B. Description of the supplies or services to be purchased The required decontamination system must use a cold plasma technology to produce an ionized hydrogen peroxide gas with a nominal particle size less than 5 um. This system must be easily transportable, expandable and with a guaranteed kill of at least 6-logs. The system must also be programmable and have the ability to be controlled remotely. The inactivating chemical must be compatible with rubber, epoxy finished surfaces, electronics and plastics.

III. Identification of the statutory authority permitting other than full and open competition 41 USC 1901(a)(1) and FAR Part 13.106-1(b): Only one responsible source

IV. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

A. Name and address of the proposed contractor(s) TOMI Environmental Solutions, 8430 Spires Way, Suite N, Frederick, MD 21701

B. Describe why only the requested supply/service will meet the government’s needs In order to effectively and safely decontaminate BSL-4 laboratory spaces we need to use a gas decontamination system. There are three options for this approach, chlorine dioxide, formaldehyde and hydrogen peroxide. Both chlorine dioxide and formaldehyde are highly toxic chemicals that each present a significant risk to human health and are harsh on laboratory equipment.

The use of chlorine dioxide will significantly reduce the life span of any equipment that contains non-stainless steel by causing oxidation (rust) on any exposed surfaces. The use of chlorine dioxide for space decontamination in not typically use in any biocontainment laboratory setting.

The typical means of decontaminating BSL-4 laboratories is through the use of formaldehyde gas. In the United States, regulations require that the formaldehyde gas must be neutralized before venting to the atmosphere. In order to accomplish this task, ammonium bicarbonate is used. However, this process leaves a significant residue on all exposed surfaces. This residue, called melamine, is very noxious and requires respiratory protection in our facility in order to clean decontaminated surfaces. The melamine can also react with metal surfaces, specifically copper, to damage electronics and shorten the effective life-time of equipment.

The use of hydrogen peroxide to decontaminate laboratory spaces is ideal as it is effective, does not leave a residue and can be vented to the atmosphere. However, the use of ‘vaporized’ hydrogen peroxide can be problematic in laboratory spaces as the vapor does not penetrate well into small spaces and can precipitate on surfaces which makes it less predictable. A novel alternative to the use of vaporized hydrogen peroxide is the use of ionized hydrogen peroxide which has the same, or better, killing effect and behaves like a gas to allow for good penetration into small spaces and cavities to provide effective kill and without damaging the equipment.

C. Describe why only the proposed contractor is capable of providing the requested supply/service The Steramist system from TOMI is the only system to our knowledge that meets the fundamental requirements for using ionized hydrogen peroxide for decontamination of BSL-4 laboratory spaces and equipment. Other hydrogen peroxide-based decontamination systems use ‘vaporized’ hydrogen peroxide (VHP) which is a larger particle size with limited penetration and a tendency to condense on cold surfaces. These characteristics of VHP systems makes them unsuitable for our needs in decontaminating our BSL-4 facility. Tomi is local and can provide easy access for support and maintenance of the equipment that we need.