JA_EWI_2016.docx

Environmental Waste lnternational's Microwave Waste Sterilization Maintenance Service Contract

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

In accordance with the authority granted under FAR Part 13, this request for a noncompetitive acquisition is hereby submitted for consideration for acquisition approval.

1. IDENTIFICATION OF THE AGENCY AND THE CONTRACTING ACTIVITY:

Requesting Agency:

USDA, APHIS, PPQ, NPGQC

BARC-East, Bldg. 580 Beltsville, Maryland 20705

Contracting Activity:

USDA, APHIS, MRPBS, ASD

Minneapolis Procurement Branch Butler Square, Fifth Floor

02/26/2016

100 North 6th Street

Minneapolis, MN 55403

2. NATURE AND/OR DESCRIPTION OF THE ACTION BEING APPROVED:

The United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Plant Protection and Quarantine (PPQ), National Plant Germplasm Quarantine Center (NPGQC), Beltsville, MD requests a noncompetitive procurement purchase order with Environmental Waste International for monthly maintenance, testing, certification, and a five year extended warranty to repair/replace the system's failed components in order to meet the original performance standards for the Microwave Waste Sterilization System. This system sterilizes High Containment effluent that might be contaminated with exotic plant pathogens or Ag Select Agents. This sole source service is requested through Requisition 796476.

3. A DESCRIPTION OF THE SUPPLIES, EQUIPMENT, OR SERVICES REQUIRED TO MEET AGENCY NEEDS (INCLUDING THE ESTIMATED VALUE OF THE ACQUISITION INCLUSIVE OF OPTIONS):

Environmental Waste International (EWI) will provide all necessary labor, parts and equipment to perform the required monthly maintenance, repairs, testing, and periodic certification to NPGQC's FS6000 Microwave Waste Sterilization System. The maintenance visit will be conducted by EWI employees who will be onsite for a minimum 2 days every other month completing the inspection/maintenance on the minimum of the following system components:

1. Panel Mate E-Pro Control Screen - The operator interface system (Control Touch System) will be inspected for proper process monitoring/control functions. Each screen/graphic will be inspected/tested for correct primary process parameters including real-time values and set points.

2.

3. Pumps - Sump Pumps Pl and P2, and all system pump seals will be inspected for leaks and all pumps will be operated to ensure proper operation.

4. Pipe Inspection -All stainless steel piping and firings will be inspected for tightness and leaks. All leaks will be repaired. Pressure relief valves will be tested for proper operation and venting pressure.

5. Air Actuated Valves (14) -solenoids for each valve will be tested to confirm that is working properly; any solenoids found to require cleaning will be taken apart, cleaned and reassembled. All manual valves will be inspected for position and operation.

6. Heat Exchanger Pressure Test - The shell and tube heat exchanger will be inspected and pressure tested to verify containment integrity.

7. Heaters -The electric heaters will be inspected for proper output and correct sequence of operation.

8. Patented Microwave System -The microwave interlocks and safety circuits will be checked and any required maintenance will be performed. EWI will also check the magnetrons and power supplies for required output. Any component found to be malfunctioning will be replaced.

8. Compressed Airline Units - All airline filters and compressors will be inspected; check and drain the oil and water filters.

9. Air Conditioning Units (2) - complete the required maintenance on the air conditioning units; replace filters, drain piping and blowers. Verify temperature output for cooling the magnetrons and power supplies.

I 0. Control Panel Indicators - Verify operation of all sequence indicator lights and replace defective units.

11. Alarm Diagnostics -Verify the accuracy and sensing of all alarm conditions.

12. Calibration -The pressure and temperature sensors will be tested to ensure they are still properly calibrated; calibration will be performed on any sensor found out of calibration.

13. Test Run -The complete microwave system will be monitored for at least one complete run for proper sequence of operation and required sterilization temperature.

14. Make minor system adjustments as requested by the USDA.

· EWI has been servicing (Contract Number AG-6395-P-10-0367) and maintaining the specialized microwave system since it was installed at NPGQC and certifying the system for deactivating Ag Select Agents and other plant pathogens. All past contracts were issued with a sole source purchase order. This service will need to be continued indefinitely due to the Ag Select Agent program at NPGQC or until the Microwave Waste Sterilization System is replaced with a steam sterilizer. The Extended Yearly Warranty will cover all parts, materials, travel, supervision, and labor required to repair/replace the systems' failed components in order for the waste sterilization system to meet the original performance standards. The

Extended Warranty quote per year is based on a five year warranty. The original Performance Standards include:

1. The system can sterilize the entire 500 gallon batched effluent up to a temperature of 285 degrees F for thirty seconds.

2. The system can process 2000 gallons per day - minimum of four batches.

3. The discharge water will be less than 140 degrees F.

4. The microwave waste sterilization system shall operate automatically.

5. Minimum of six magnetrons operating during a sterilization cycle.

The requested 5 year service contract is for a base year with four option years. The base service contract period is from September 1, 2016 through August 30, 2017.

4. IDENTIFICATION OF THE STATUATORY AUTHORITY PERMITTING NONCOMPETITIVE ACQUISITIONS:

The National Plant Germplasm Quarantine Center (NPGQC) in Beltsville, Maryland, is a critical mission APHIS facility that operates 24/7. The Phase I and II Planned Expansion construction at NPGQC is complete and includes a 16,000 square foot BSL-3AG High Containment Laboratory and Greenhouse and associated BSL-3AG biological waste treatment system. The biological waste treatment system sterilizes High Containment effluent that could be contaminated with exotic plant pathogens or Select Agents. The deactivation system was installed to satisfy the APHIS Select Agent Regulations (7 CFR 331) and the CDC Select Agents Regulations (42 CFR Part 73) in order to guarantee the bio-security and bio-containment of Select Agents at NPGQC. The system was designed and built by EWI to specifically meet the requirements of the USDA Bio-security Policies and Procedures for BSL-3 pathogens.

The FS6000 Microwave Waste Water sterilizer was designed and manufactured by Environmental Waste International (EWI), utilizing their patented “Reverse Polymerization" process. The "Reverse Polymerization" process utilizes microwave energy to break down carbon molecules, in the case of waste water it is used to sterilize the water. This was the first microwave system built for sterilizing waste water/contaminated effluent by EWI and to date no other company has built a similar system to deactivate Ag Select Agents or has the capability to maintain the EWI microwave system at NPGQC. The microwave components are covered under EWI's "Microwave Delivery System" patent number CA2659510 and the complete process as it applies to sterilizing waste water is covered under patent CA2529608 and patent pending 20070131603. EWI is the only company with the technical expertise to properly diagnosis microwave system malfunctions. Other manufacturers and service providers do not offer microwave sterilization technology and are not capable of maintaining/repairing the unique waste sterilization system.

The uniqueness of the system, lack of qualified competitors, and the patented microwave technology supports a sole source contract award rather than a full and open competition. Currently the proposed contract action is for services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302.

5. A DEMONSTRATION THAT THE PROPOSED CONTRACTOR'S UNIQUE QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES USE OF THE AUTHORITY CITED:

A Comparison Study of Alternatives for the BSL-3 Sterilizer Equipment was prepared by Ellerbe Becket and Greenhorne & O'Mara, Inc., and was used as part of the selection process. The study included design proposals from Waste Reduction, Inc., Anchor Autoclave, Environmental Ware International, and Kinetics Group (WHE). The biological waste deactivation system was designed to perform pre-programmed thermal deactivation of aqueous biological waste containing plant pathogens. All systems must be capable of heating the effluent up to a temperature of 285 degrees F for thirty seconds. Environmental Waste International (EWI) was awarded the contract (Contract Number 50-32KW-3-006) to design, furnish, and install a biological waste treatment system at the USDA-APHIS National Plant Germplasm Quarantine Center in Beltsville, Maryland.

The contract included a five year extended warranty that stated EWI would provide all labor and repair or replace the system’s failed components if the microwave system failed to operate to the USDA's accepted standard. The system, designed and built by EWI, is still the only current system in the United States utilizing microwave technology to deactivate Ag Select Agents. This system was designed specifically to meet USDA's requirements and utilizes proprietary FS6000 EPROM cards, control circuits, and programmable logic controllers controlling 14 magnetrons.

The required waste treatment preventive maintenance, repair, testing, and certification can only be accomplished by EWI. Other manufactures, including those in the study, do not offer similar microwave sterilization technology and are not capable of maintaining/repairing the unique waste sterilization system.

They would have to sub the work to EWI to perform the required EPROM testing, and preventive maintenance. The microwaves are generated by magnetrons with EWI’s patented proprietary modifications that boost the intensity of the microwave radiation and prevent the magnetrons from interfering with each other. EWI is the only company with the technical expertise to properly diagnosis microwave system malfunctions.

As stated above, EWI is the only company with the technical expertise to properly diagnose microwave system malfunctions. Other manufactures and service providers do not offer microwave sterilization technology and are not capable of maintaining/repairing the unique waste sterilization system. Other unique qualifications include:

· The complete system is controlled by a Program Logic Controller (PLC) with proprietary software designed by EWI, due to the complexity of the system and the potential hazards if there are software issues, should only be addressed by EWI personnel.

· Only individuals trained by EWI should perform work on the patented "Microwave Delivery System", someone not familiar with the system could cause serious harm to personnel, equipment, and nearby government property.

· The system utilizes microwave components specific to EWI's design.

· Pressure control is vital to the operation of the system, maintaining the process to control and maintain the correct pressures is vital to the proper operation and testing of the overall system.

· Part of the microwave delivery system is a proprietary microwave power supply that generates the high voltage to generate the microwave energy. Each microwave power supply generates 5,000 VDC and transmits this voltage to the magnetron; only individuals familiar with the design (EWI) should perform maintenance on this type of equipment.

6. A DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE SOLICITED FROM AS MANY POTENTIAL SOURCES AS IS PRACTICABLE, INCLUDING WHETHER A NOTICE WAS, OR WILL BE, PUBLICIZED AS REQUIRED BY FEDERAL ACQUISITION REGULATION (FAR) SUBPART 5.2, AND IF NOT, WHICH EXCEPTION UNDER FAR 5.202 APPLIES:

As mentioned in Item # 5 above, a Comparison Study of Alternatives for the BSL-3 Sterilizer Equipment was prepared by Ellerbe Becket and Greenhorne & O'Mara, Inc., and was used as part of the initial waste sterilization equipment selection process. The study included design proposals from Waste Reduction, Inc., Anchor Autoclave, Environmental Waste International, and Kinetics Group (WHE). The microwave waste sterilization system was selected from the other three traditional steam sterilization systems. The other three manufacturers did not have the technology to design a microwave system nor the expertise to maintain such a system. They were also not willing to go through all of the testing to certify that their design could deactivate Ag Select Agents.

Service contractors that work on NPGQC's traditional laboratory steam sterilizers (Steris, Beat Star, and Getinge) were asked if they could provide the required service. All parties agreed that they would not attempt to service the EWI microwave waste sterilization system nor were they willing to accept the liability of the system not functioning correctly. They did not want to be responsible for the possible release of potentially harmful agricultural pathogens into the surrounding environment. The specialized processing tank alone is beyond their normal service capability. The high heat and pressure stainless steel vessel is fed from the heat exchanger with preheated effluent and houses six electric heaters and fourteen magnetrons. The tank is insulated and fitted with a climate controlled cabinet (fan forced chilled water cooling to temper the magnetrons) housing the microwave detection safety sensors. The processing tanks contain numerous temperature and pressure sensors along with pneumatic air feed and bleed fixtures to maintain required pathogen deactivation conditions. The contractors would not be willing to service the batch tank without technical help from EWI.

This was also true with the control and power cabinet that contains the graphically user interfaced programmable logic controller manufactured by Allen Bradley. The state-of-the- art control system is outfitted with I/O modules and additional control functions which are performed through expansion modules networked via Ethernet connection hubs using the device net protocol. The local contractors do not have the technical capability to work on the logic controllers, perform microwave control repair, and the diagnostic capability to service the patented microwave power supplies. Once again they would have to contract the service work out to EWI. EWI holds the rights to the operating program.

There have been recent advances in the use of microwave technology by manufactures for the disposal of medical waste but not for the sterilization of hazardous liquid effluent. Companies such as Pollution Engineering, Sanitec International, and researchers at NASA Ames Research Center are using microwave incineration to process biological wastes. Microwaves assist in the disinfection of medical waste. EWI also has such a system for processing medical waste. The medical waste is heated until only carbon residue is left. They modified their microwave technology to meet our liquid effluent requirement. The ability to guarantee that a liquid batch system has been sterilized throughout without any stratification than to process material into a solid waste is much more difficult than the process to sterilize medical wastes.

Applied microwave technology systems are being used instead of traditional incineration to reduce air emissions. I am unaware of any other microwave system that is used to deactivate plant or animal pathogens in a liquid waste stream. Most traditional systems on the market do not reach the 285 degree level that we need for pathogen destruction. These companies at the current time will not attempt to service other manufactures' sterilization systems and accept the liability associated with the required certification. The ability to heat the waste to 285 degrees for thirty seconds is critical to ensure that the waste is safe for disposal.

7. A DETERMINATION BY THE CONTRACTING OFFICER THAT THE ANTICIPATED COST TO THE GOVERNMENT WILL BE FAIR AND REASONABLE, AND THE BASIS FOR THAT DETERMINATION:

The anticipated price is fair and reasonable considering the level of service that will be obtained. The contractor will extend the warranty as per their original five year warranty, in that if the system fails to operate of the accepted standards of the USDA per the original purchase contract, they will repair or replace the system's failed components to return the system to performance standards. The monthly maintenance pricing has remained the same as last year.

8. A DESCRIPTION OF THE MARKET RESEARCH CONDUCTED (FAR PART 10) AND THE RESULTS, OR AN EXPLANATION OF THE REASON MARKET RESEARCH WAS NOT PERFORMED:

The requirement was posted as a special notice on 5/23/2016, stating that we intend to issue a sole source contract to EWI. There have been no responses or inquiries to date.

9. ANY OTHER FACTS SUPPORTING THE USE OF OTHER THAN FULL AND OPEN COMPETITION - FAR 6.303-2(a)(9): ·

Subject has been well-covered in the narrative above.

10. A LISTING OF SOURCES, IF ANY, THAT EXPRESSED, IN WRITING, AN INTEREST IN THE ACQUISITION:

None.

11. A STATEMENT OF THE ACTIONS, IF ANY. THE AGENCY MAY TAKE TO REMOVE OR OVERCOME ANY BARRIERS TO COMPETITION BEFORE ANY SUBSEQUENT ACQUISITION FOR THE SUPPLIES, EQUIPMENT, OR SERVICES REQUIRED:

There are no current actions that can be taken at the present time to overcome the limited expertise with servicing the microwave waste sterilization system with proprietary software designs and components.

Someone not familiar with the system could cause serious harm to personnel and equipment. A potential breach in our containment of Select Agent pathogens due to faulty serviced equipment could jeopardize our Select Agent certification and our ability to work on such pathogens for APHIS.

12. I HEREBY CERTIFY THAT THE INFORMATION PROVIDED IN TIDS JOFOC IS ACCURATE AND COMPLETE TO THE BEST OF MY KNOWLEDGE AND BELIEF.

Patricia Simon Date Paul Perry Date Contracting Officer Facility Manager Minneapolis Procurement Branch PPQ, NPGQC, Beltsville, MD

02/16/2016