ML17363A409

NWMI-003 - Statement of Qualifications in Support of Northwest Medical Isotopes, LLC Medical Radioisotope Production Facility Construction Permit Application

ML17363A409
Person / Time
Site:	Northwest Medical Isotopes
Issue date:	12/29/2017
From:	Northwest Medical Isotopes
To:	NRC/OGC
SECY RAS
References
50-609-CP, Construction Permit Mndtry Hrg, RAS 54137
Download: ML17363A409 (15)

Text

Exhibit NWMI-003 Roy W. Brown Roy W. Brown Curium, VP, Government Affairs & Strategic Alliances Experience Overview Education, Certifications and Affiliations MA, Business Administration, Roy Brown has more than 30 years of experience in the Webster University, 1987 nuclear medicine industry. He currently serves as the co-BS, Radiation Biophysics, Chair of the Council on Radionuclide and Radiopharmaceuticals, Inc. (CORAR) Isotope Supply University of Kansas, 1978 Committee and as the Chairman of the Board for Years of Experience CORAR. He is a member of the Society of Nuclear 39 years total Medicines task force on molybdenum-99 (99Mo), is 30+ years in the nuclear medicine Curiums representative to the European Nuclear Energy industry Associations Organization for Economic Cooperation 9+ years in Health Physics, EHS and Development (OECD) Committee on Medical Isotope Supply, serves on the White House Office of Work History Science & Technology Policy Committee on the Supply 2011-present, VP, Government Affairs of Medical Radionuclides, is a member of the European

& Strategic Alliances, Curium Commission Observatory on the Supply of Medical Pharmaceuticals (and predecessor Isotopes, serves on several International Atomic Energy companies) Agency (IAEA) committees dealing with 99Mo and 133Xe 2005-2011, President, Nuclear production, is on the European-based Association of Medicine Solutions, Inc. Imaging Producers and Imaging Suppliers (AIPES) 2002-2005, President, TCI Medical Inc. Reactor and Isotopes Working Group, and serves on the 2000-2002, Consultant AIPES General Assembly.

1978-2000, Various positions, Mr. Brown currently serves as the Vice President of Mallinckrodt Government Affairs & Strategic Alliances for Curium.

Curium is the worlds largest radiopharmaceutical Relevant Highlights manufacturer, with manufacturing plants in Maryland Serves on the European Observatory Heights, Missouri; Petten, Netherlands; and Saclay, Working Group on Global Research France. Curium holds a broad-scope license for its Reactor Scheduling operation in Maryland Heights. The company also has a Member of the White House Office of bulk 99Mo manufacturing plant in the Netherlands.

Science & Technology Policy Mr. Browns principal responsibility is development of Committee on the Supply of Medical the companys strategy for long-term radionuclide Radionuclides supplies, including 99Mo. He also engages with state and Serves on several IAEA Coordinated federal legislators, regulatory agencies, and trade Research Projects on the production associations to educate and advocate on behalf of of Mo-99, and the Conversion from Curium.

HEU to LEU for the production of Medical Radionuclides. Selected Presentations Served on the Department of Energy Current Tc-99m Supply Chain Issues and the Effect that Nuclear Science Advisory Committee LEU Conversion Has Had on the Supply, The Missouri on Isotopes from 2008-2009 and 2014-Valley Chapter of SNM Annual Meeting, Overland Park, 2015.

Kansas, September 16, 2017.

Serves on the Board of Directors for the Education & Research Foundation DOE, 2017, Challenges and Opportunities on the Path for Nuclear Medicine to LEU Conversion, U.S. Department of Energy Mo-99 Topical Symposium Meeting, Montreal, Canada, September 11.

Roy W. Brown Statement of Qualifications (Docket No. 50-609-CP) 1

Exhibit NWMI-003 NAS, 2017a, Current and Future Plans for the Production of Mo-99, Russian National Academy of Sciences-U.S. National Academy of Sciences, Symposium on Mo-99 Production, Vienna, Austria, July 17.

NAS, 2017b, Conversion to Low-Enriched Uranium Based Mo-99 Production, Russian National Academy of Sciences-U.S. National Academy of Sciences, Symposium on Mo-99 Production, Vienna, Austria, July 18.

NAS, 2017c, Regulatory Perspectives from a Tc-99m Generator Manufacturer, Russian National Academy of Sciences-U.S. National Academy of Sciences, Symposium on Mo-99 Production, Vienna, Austria, July 19.

CME Course, 2017, Current Tc-99m Supply Chain Issues and the Effect that LEU Conversion has had on the Supply, Continuing Medical Education, Society of Nuclear Medicine Annual Meeting, Denver, Colorado, June 12.

FNMT, 2017, Molybdenum-99 (Mo-99) Supply Update, 46th Annual Meeting of the Florida Nuclear Medicine Association, Tampa, Florida, May 6.

The Current Supply of Mo-99, Canadian Medical Isotope Working Leaders Group, Ottawa, Canada, April 3, 2017.

Update on Curiums Effort to Convert to Low Enriched Uranium, The European Union Observatory on the Supply of Medical Isotopes, Luxembourg City, Luxembourg, March 28, 2017.

Current Supply Challenges with Mo-99 and Other Medical Radionuclides, American Pharmacists Association Annual Meeting, San Francisco, California, March 25, 2017.

Mo-99 Production and Effective Control of Xe-133 Emissions Comprehensive Test Ban Treaty Organization, Workshop on Signatures of Man-made Isotope Production (WOSMIP VI), Bariloche, Argentina, November 30, 2016.

Roy W. Brown Statement of Qualifications (Docket No. 50-609-CP) 2

Exhibit NWMI-003 Ralph A. Butler, PE Ralph A. Butler, PE NWMI Senior Advisor Experience Overview Education, Certifications, and Affiliations Ralph Butler, PE, has over 35 years of nuclear MS, Nuclear Engineering, University of experience in the management, oversight, and operation Missouri - Columbia of Navy, commercial, university, and U.S. Department BS, Engineering Management, of Energy (DOE) facilities, both domestic and University of Missouri - Rolla international. His experience includes power plant and U.S. NRC Senior Reactor Operator research reactor operations, program management, License (30560), Westinghouse PWR quality improvement and assessment activities, and Registered Professional Engineer, independent safety reviews.

Missouri (E-20909) Mr. Butler is currently serving as a Senior Advisor to Member, American Nuclear Society, Northwest Medical Isotopes, LLC (NWMI) on the since 1983 licensing and final design of the Radioisotope Past Chair of the National Organization Production Facility to be constructed in Columbia, of Test, Research, and Training Missouri, near the University of Missouri Research Reactors (TRTR) Reactor (MURR).

Years of Experience Relevant Project Experience 48 years (total) 35+ years of nuclear experience University of Missouri Research Reactor Center, Columbia, MO 2000 - 2017 Work History Executive Director 2000 - 2017, MURR Responsible for the safe, legal, and efficient operation of 1993 - 2000, DOE/DoS the University of Missouris 10 MW research reactor 1989 - 1992, Consultant (commercial (MURR), the most powerful university-operated nuclear power) research reactor in the U.S. with a staff of 180. MURR 1981 - 1989, Union Electric Company is a multidisciplinary research center with a three-fold 1969 - 1975, US Navy mission of promoting interdisciplinary research, providing an education opportunity for students, and Relevant Highlights providing irradiation and isotope production services to Registered professional engineer (PE) researchers, medical institutions, and private companies Former NRC licensed Senior Reactor worldwide.

Operator U.S. Department of Energy (DOE) and Department of Served on American Nuclear Society State (DoS), Washington, DC 1993 - 2000 Executive Committees for several ANS Program Manager, Argonne National Laboratory divisions Served as overall program manager of Argonnes Maryland office.

Awards Recipient, Missouri Honor Award for Program Manager, DOE Office of Nonproliferation Distinguished Service in Engineering, and National Security Managed special nuclear material protection, control, University of Missouri College of and accounting upgrades at four Russian nuclear Engineering, 2008 institutes.

Recipient (two times), VP Al Gore's National Performance Review Senior Technical Advisor, DoS Certificate of Appreciation (Hammer Advised on matters related to two light water reactors Award) being provided to the Government of the Democratic Peoples Republic of Korea, North Korea.

Paul Harris Fellow, Rotary International Ralph A. Butler, PE Statement of Qualifications (Docket No. 50-609-CP) 3

Exhibit NWMI-003 Consultant, DOE Domestically conducted management and technical evaluations of DOE nuclear facility operations, radioactive waste management policies, and decommissioning activities for the Office of Environmental Management and Nuclear Safety.

Served as senior advisor to Brookhaven National Laboratorys Reactor Division in the development and implementation of a three-year restart project of the high flux beam reactor and with transition to a new management contract.

Rochester Gas & Electric - Rochester, NY 1990 - 1992 Consultant Under contract to manage a $6 million, fixed-price maintenance upgrade project. Responsibilities included design specification research, development of an engineered maintenance analysis relational database, and incorporation of reliability centered maintenance recommendations into enhanced maintenance procedures. As Operations Specialist, duties included performing 10 CFR 50.59 reviews and determining post-maintenance operability testing requirements.

Virginia Power - Richmond, VA 1989 Consultant, Corporate Nuclear Safety Group Served as Principal Engineer leading the independent review of a large backlog of safety documents for the Surry and North Anna nuclear plants. Performed special investigations as requested by utility executives for reactor trips, operational events, design changes, and engineering work requests.

Union Electric Company, Callaway Nuclear Plant - St. Louis, MO 1981 - 1989 Supervising Engineer, Quality Assurance Directed a group of degreed QA engineers responsible for the assessment and evaluation of the Operations, Instrumentation and Controls, Maintenance, and Work Control departments from a technical and legal aspect.

Control Room Supervisor and Refueling Senior Reactor Operator, Operations Department Supervised all activities related to the safe, legal, and efficient operation of the reactor systems and equipment within the Callaway Nuclear Plant. Directed operational activities, including scheduling, authorization, and acceptance of work and test activities; training and scheduling of operations personnel; and the review and revision of plant procedures.

Shift Technical Advisor/Engineer, Independent Safety Engineering Group Provided advanced technical assistance to the operating shift complement during normal and abnormal operating conditions; assisted the operations staff in interpreting and applying the requirements of technical specifications; performed an early review of the planned activities for the upcoming shift to ascertain whether special considerations or precautions were warranted.

Developed the program for the review, evaluation and dissemination of plant and industry operating experience information such as Institute of Nuclear Power Operations (INPO) significant event reports (SER), significant operating experience reports (SOER), and NRC I&E Bulletins and Notices, performed the first Callaway Plant probabilistic risk assessment (PRA), developed procedures for the independent review of various plant departments, and assisted in the development of a listing of reactor trip single point failure components.

U.S. Navy 1969 - 1975 Machinist Mate First Class, USS SCULPIN (SSN-590)

Qualified Engineering Watch Supervisor and Engineroom Supervisor. Served as Mechanical Divisions Leading Petty Officer. Also served as ships welder and diesel engine petty officer.

Ralph A. Butler, PE Statement of Qualifications (Docket No. 50-609-CP) 4

Exhibit NWMI-003 Michael R. Corum Michael R. Corum Atkins Vice President, Energy (Nuclear)

Experience Overview Education, Certifications and Affiliations Michael (Mike) Corum is a subject matter expert with MS, Nuclear Engineering, University of over 27 years of experience in the nuclear industry. His Tennessee, 1991 broad experience base in nuclear criticality safety BS, Nuclear Engineering, University of includes expertise in radiation shielding, hazards Tennessee, 1990 analysis, packaging and transportation, and core reload BA, Biology, University of Tennessee, analysis. He has extensive experience in both facility 1981 support and packaging and transportation (fresh and Years of Experience spent fuel). Additional areas of expertise include integrated safety analysis (ISA), fault tree analysis, 36 years (total) qualitative and quantitative methods of hazards 27 years in the nuclear industry assessment, shielding analysis using Monte Carlo N-Work History Particle (MCNP) code, validation and benchmarking of 2001 - Present, Atkins (member of criticality codes, nuclear reactor core design, and reactor SNC Lavalin Group) physics calculations in support of reload safety analysis 1982 - 2001, Various companies efforts. Mr. Corum is an experienced user of MCNP, KENO V.a, KENO VI, the SCALE system (including Relevant Areas of Expertise SAS and CSAS sequences), PHOENIX, and the Nuclear criticality safety Advanced Nodal Code (ANC).

Radiation shielding Since 2012, Mr. Corum has supported Northwest Packaging and transportation - Safety Medical Isotopes, LLC (NWMI) during development of analysis report for packaging (SARP) the construction permit and operating license development applications for the NWMI Radioisotope Production Hazardous analysis Facility (RPF). He also provided regulatory support Reactor core reload analysis during Advisory Committee on Reactor Safeguards Integrated safety analysis (ACRS) meetings for the construction permit Fault tree analysis application. His support includes subject matter Qualitative and quantitative methods expertise in criticality safety, shielding, and ISA. In of hazards assessment addition, he provides interface support for natural phenomena hazards, external event analysis, fire hazard analysis, radiation protection, and thermal hydraulics.

Mr. Corum became a strategic partner to NWMI for final design phase plan development.

Relevant Project Experience Atkins, Columbia, SC 2001 - present Vice President Operations, Commercial Nuclear and Specialty Engineering Division Vice President Operations (2004 - 2017) - Performs management oversight for the Atkins Nuclear and Specialty Engineering Division. Responsibilities include business financial oversight, strategic decision making, business development, personnel recruitment, contract negotiation, joint marketing ventures, technical capabilities development, and marketing to prospective clients. Functional groups managed include licensing, commercial nuclear business development, reactor core physics, health physics, shielding, radiation protection, reactor thermal hydraulics, criticality safety, risk assessment, probabilistic risk assessment (PRA), reactor severe accident modeling, fire protection, specialty structural engineering, and GLASS software development.

Michael R. Corum Statement of Qualifications (Docket No. 50-609-CP) 5

Exhibit NWMI-003 Core Design Engineer, Westinghouse Electric Co., Pittsburgh, PA (2008 - 2011) - Performed numerous core reload safety analysis calculations for various utility customers while supporting the Westinghouse Core Design group in Pittsburgh. Analyses included moderator temperature coefficient, doppler coefficient and defect, beta-effective, control rod operational limits, shutdown margin, trip reactivity, rod misalignment, dropped rod, dropped bank, single rod withdrawal, rod withdrawal at power, rod bank withdrawal from subcritical, boron dilution accident, post-LOCA (loss of coolant accident) long-term cooling critical boron, rod ejection accident analysis, steam line break analysis, boron design requirements, integral fuel burnable absorber (IFBA) power suppression, locked rotor, and maximum rod power census for LOCA.

Westinghouse Electric Company, Columbia, SC (2004 - present) - Performed numerous nuclear criticality calculations using MCNP to support the nuclear criticality safety evaluation (NCSE) for the boiling water reactor (BWR) fuel bundle inspection area and the fuel assembly storage area. Participated on the design team for the fuel bundle inspection insert and the fuel assembly storage racks. Authored the NCSE for the Columbia Fuel Fabrication Facility (CFFF) BWR fuel bundle inspection area and the fuel assembly storage area to demonstrate double contingency and incorporate requirements of 10 CFR 70.61.

Authored numerous other NCSEs in support of the CFFF Criticality Safety Program recovery effort.

Performed criticality accident alarm system placement calculations, immediate evacuation zone (IEZ) evaluation, and dose assessments for workers using MCNP for the CFFF. Provide continuing criticality safety support to the facility.

Cameco, Port Hope, Ontario (2004 - 2005) - Managed the establishment of a comprehensive criticality safety program at the Cameco Port Hope fuel manufacturing facility. Developed the schedule and allocated the resources necessary to complete the program for Cameco. The program scope included formal procedures to define the criticality safety program and NCSEs to document the safety basis for the proposed fissile material operations in the Slightly Enriched Uranium (SEU) Facility. The NCSEs are completed following a hazards assessment involving Atkins and Cameco process engineers, design engineers, operators, and supervisors.

Zircatec Precision Industries, Port Hope, Ontario (2004 - 2006) - Managed the establishment of a comprehensive criticality safety program at the fuel manufacturing facility. Developed the schedule and allocated the resources necessary to complete the program. The program scope includes formal procedures to define the criticality safety program and NCSEs to document the safety basis for the proposed fissile material operations in the SEU facility. The NCSEs are completed following a hazards assessment, directed by Atkins, involving process engineers, design engineers, operators, and supervisors.

Nuclear Fuel Services, Erwin, TN (2001 - 2004) - Performed numerous nuclear criticality calculations using SCALE 4.3 to support the NCSE for the solvent extraction and uranium-aluminum dissolution operations at the Blended Low Enriched Uranium (BLEU) Processing Facility. Authored NCSEs for the new BLEU processing facility solvent extraction and uranium-aluminum dissolution operations to demonstrate double contingency and incorporate requirements of 10 CFR 70.61. Performed shielding calculations using MCNP to support various operations in the new BLEU Processing Facility.

Performed criticality analysis to support licensing of the RAJ-II BWR fresh fuel container. Employed innovative analysis techniques to define acceptable fuel parameter ranges that allow for future fuel design changes without the need for a shipping container license amendment. Authored Chapter 6 of the RAJ-II Safety Analysis Report (SAR).

Westinghouse Electric Company, Columbia SC and Pittsburgh, PA 1992 - 2001 Engineer/Senior Engineer B/Senior Engineer B, Commercial Nuclear Fuel Division Performed numerous nuclear criticality analyses to demonstrate double contingency of operations.

Supported analyses with KENO V.a/SCALE and MCNP calculations. Also developed fault trees in support of the criticality analyses to demonstrate double contingency protection as part of the ISA process.

Michael R. Corum Statement of Qualifications (Docket No. 50-609-CP) 6

Exhibit NWMI-003 Developed methodology for the Wesflex transfer, storage, and transportation cask criticality design effort.

Coordinated and served as the lead engineer for the criticality effort for the multi-purpose canister system and the first-of-a-kind criticality analysis for the Temelin fresh fuel transfer containers and spent fuel storage racks. Drafted numerous reports and presented technical information to customers, senior staff, and U.S. Nuclear Regulatory Commission (NRC) and U.S. Department of Energy (DOE) officials.

Provided reload core design services to Westinghouse clients in the commercial nuclear power industry.

Performed shielding analyses using MCNP for both transportation casks and nuclear reactor designs.

Westinghouse Savannah River Company, Inc. - Aiken, SC 1991 - 1992 Engineer Performed quantitative risk analysis (PRA) and qualitative hazards assessment support for the solid waste disposal facility at the Savannah River Site. Performed numerous risk assessment analyses, led teams, and authored several SARs. Used techniques and analysis methodology learned from the Process Safety Institute courses on qualitative and quantitative methods of hazards assessment. Developed a Monte Carlo approach for accident analysis of helicopter flights over the Solid Waste Disposal Facility.

University of Tennessee - Knoxville, TN 1988 - 1991 Research Assistant and Graduate Research Assistant United States Air Force - San Antonio, TX, Sacramento, CA, Merced, CA, Blytheville, AR 1982 - 1988 Captain - Bombardment Heavy Wing, Strategic Air Command, Blytheville Air Force Base, AR Wing Instructor, Electronic Warfare Officer (1986 - 1988) - As a member of the Wing Commanders Staff, organized, coordinated, and directed all electronic warfare activity, defensive measures, electronic countermeasures equipment, and electronic combat tactics. Developed and provided training in relation to Operational Readiness Inspections (ORI) and crew combat tactics. Participated in Giant System tests to improve electronic combat systems capability and received a letter of appreciation for contribution.

Training Flight Instructor, Electronic Warfare Officer (1986) - Managed all training activities for the squadron, prepared personnel schedules, and coordinated programs. Cited for excellence at the Squadron Officer School, as one of the prestigious courses outstanding presenters.

Electronic Warfare Officer Instructor (1985 - 1986) - Planned, organized, conducted, and evaluated operational training in relation to interception, analysis, masking, and jamming of enemy electromagnetic activity. Directed airborne defense of the manned bomber leg of the Strategic Air Commands nuclear triad. Maintained mission readiness status by performing combat crew alert duty in support of the global Single Integrated Operational Plan and Emergency War Order operations. Selected to serve as an audit officer for the critical munitions supply accounts.

Navigator/Electronic Warfare Officer (1981 - 1985) - Attained navigator rating and specialized in electronic warfare. Assured quality and continuity of training in Emergency War Order procedures and techniques for B-52 aircraft. Planned, organized, conducted, and evaluated operational training.

Developed countermeasures to defeat enemy ground and airborne weapons, command, and control systems. Represented the 97th Bombardment Wing in the annual Bombing and Navigation Competition, and received the highest score by compiling over 50 error-free runs. Received perfect test scores on Strategic Air Commands most difficult evaluations, the ORI and 1st Combat Evaluation Group.

Michael R. Corum Statement of Qualifications (Docket No. 50-609-CP) 7

Exhibit NWMI-003 Gary Dunford Gary Dunford AEM Consulting, LLC - Managing Partner Experience Overview Education, Certifications and Affiliations BS, Chemical Engineering, Gary Dunford has a strong background in plant University of North Dakota, 1978 operations and providing process engineering support to radioactive/mixed waste facilities. His experience Years of Experience extends into systems engineering applications, flowsheet 38 years (total) development, conduct of operations principles, 38 years at DOE sites operational readiness activities, safety documentation 31 years in waste retrieval preparation, and authorization basis implementation.

technologies at DOE sites Mr. Dunford is noted for his ability to identify innovative solutions to problems and bring diverse groups together Work History to complete projects. He has worked on projects and is 2001 - present, AEM Consulting LLC familiar with the various sites within the U.S.

1997 - 2001, WASTREN, Inc. Department of Energy (DOE) complex, including the 1979 - 2001, Various Hanford Site Hanford Site, Idaho National Laboratory, and Savannah M&O contractors River Site.

Relevant Highlights Mr. Dunford serves as the AEM Consulting, LLC (AEM)

Direct management responsibility for Process Engineering Manager supporting Northwest more than $25M of task-based Medical Isotopes, LLC (NWMI), with responsibility for projects for Hanford tank farms, most developing the radiochemical separation processes, involved preparing or contributing to developing flowsheet conditions, and sizing of process technical studies and reports related equipment for the NWMI Radioisotope Production to Hanford waste retrieval and Facility. Tasks include preparing process flow diagrams, processing piping and instrumentation drawings, and process descriptions. He also provides operations and 10 years of experience with all aspects maintenance and a safety analysis perspective to NWMI.

of day-to-day Hanford tank farms operations, including waste retrieval Mr. Dunford served as the Assistant Manager for Facility and transfer operations Operations and was responsible for the daily operations Key participant in the development of of the Hanford tank farms and readiness activities for new process models to support special activities and projects. Additionally, his staff baseline case planning for the Hanford successfully installed the Tank SY-101 mixer pump, which mitigated DOEs top priority safety issue at the River Protection Project mission time.

Responsible for a 60-person, multi-organizational project team assigned Mr. Dunford served as the Manager of Tank Farms Plant to complete the Tank Waste Engineering, a role that had him overseeing a Remediation System Final Safety multidisciplined engineering organization responsible for Analysis Report, and to communicate the plant, process, and design engineering functions for the results to regulators and the tank farms, grout, and evaporator facilities. He was public responsible for upgrades to ensure that major modifications were properly designed, safely installed, Extensive experience in systems formally tested, and systematically turned over, including engineering, assessments, alternative operational readiness activities.

evaluations, system optimization, and flowsheet development Mr. Dunford developed, marketed, and implemented a project plan and strategies to complete the Hanford Sites first DOE Order-compliant final safety analysis report.

He implemented a prototype risk status and review process to reduce DOEs approval time by half.

Gary Dunford Statement of Qualifications (Docket No. 50-609-CP) 8

Exhibit NWMI-003 Relevant Project Experience AEM Consulting, LLC - Richland, WA 2001 - present Principal Serves as AEM Process Engineering Manager supporting development of the construction permit and operating license applications for the NWMI Radioisotope Production Facility and submittal of those applications to the U.S. Nuclear Regulatory Commission (NRC). Responsibilities include developing the radiochemical separation processes, developing flowsheet conditions, and sizing of process equipment for the facility.

Prepared or contributed to numerous technical studies and reports related to Hanford waste retrieval and processing, including C Farm 100-series tanks, and the alternatives evaluation for retrievals based on deep sludge gas release events.

Prepared or contributed to numerous technical studies and reports related to Hanford baseline case planning, including the River Protection Project (RPP) waste retrieval mission analysis and the Strategic Initiative Analysis plans. Managed the development of two new models integral to Hanford RPP baseline case planning: TOPSim, a dynamic simulation for modeling waste tank retrieval and processing operations, and the Life-Cycle Cost Model (LCCM).

Westinghouse Hanford Company, Richland, WA 1995 - 1997 Manager Final Safety Analysis Report (FSAR) development - Oversaw a multi-organizational team that completed the Tank Waste Remediation System FSAR. Acted as the primary interface with stakeholders, DOE Headquarters, and the Defense Nuclear Facilities Safety Board (DNFSB). Responsible for communicating technical approaches and results to regulators and the public.

Westinghouse Hanford Company - Richland, WA 1993 - 1995 Manager Waste tank upgrade, installation, and testing - Responsible for ensuring that major upgrades to support waste systems operation and waste retrieval and transfer were properly designed, safely installed, formally tested, and systematically turned over, including operational readiness activities.

Westinghouse Hanford Company - Richland, WA 1987 - 1993 Manager, Tank Farms Plant Engineering, and Assistant Manager for Facility Operations Tank Farms operations and engineering - Co-managed an operating staff of over 400 direct report and matrix support personnel. Sponsored and defended the 242-A Evaporator Safety Analysis Report before DOE Headquarters review teams to support 242-A Evaporator restart efforts. Initiated conduct of operations principles into operations and acquired staff to make a step-change improvement in the conduct of operations throughout operations and maintenance. A highlight of this period was the successful installation of the Tank SY-101 mixer pump, which mitigated DOEs top priority safety issue.

Responsible for day-to-day operations and technical support for all tank farms activities, including waste tank retrieval and transfer and waste systems operations.

Rockwell Hanford Operations - Richland, WA 1987 - 1997 Manager, Waste Concentration, and Manager/Engineer, PUREX Shift Engineering Waste Concentration Unit - Responsible for providing process engineering support for radioactive liquid waste concentration, interim storage, and transfer. Oversaw the process engineers design review and startup support for new tank farms construction projects.

PUREX Facility - Responsible for the 24-hour/day process engineering support to the reprocessing facility. Monitored and maintained process chemistry during operations and established facility configurations to support special nuclear materials inventories. Became a Certified Process Engineer for the plants solvent extraction and plutonium processing systems. Managed a series of engineering and supervisory assignments to support Hanford 200 Area processing facilities.

Gary Dunford Statement of Qualifications (Docket No. 50-609-CP) 9

Exhibit NWMI-003 Nicholas F. Fow ler, NWMI CEO Nicholas F. Fowler NWMI Chief Executive Officer Experience Overview Education, Certifications and Affiliations Nicholas Fowler is a serial entrepreneur, active angel M.S., Industrial Engineering and investor, and technology industry veteran. He currently Engineering Management, Stanford serves as Chairman and Chief Executive Office of University, 1981 Northwest Medical Isotopes, LLC (NWMI). Mr. Fowler B.A., Economics, Stanford University, co-founded NWMI in 2010 with a primary mission to 1980 provide a domestic, secure, and reliable supply of Years of Experience molybdenum-99 (99Mo) for medical diagnostics for 36 years (total) ailments such as cancer, heart disease, and bone and kidney disease.

30 years in executive management 13 years as Chief Executive Beginning in 1981, Mr. Fowler spent 25 years with the Hewlett-Packard Company. As Director and General Work History Manager, he led the creation of several major new 2010 - present, Northwest Medical businesses, including notebook computers, personal Isotopes, LLC digital assistants, and internet sales and support.

2004 - present, Orion Ventures, LLC 1981 - 2005, Hewlett Packard Mr. Fowler was the founder or instrumental in the Company growth of numerous startup ventures, including Perpetua Power Source Technologies, Inc. (a world leader in Honors/Affiliations thermoelectric technologies), ZAPS Technologies, Inc.

2014 - present, Oregon State (an innovator in optical spectrophotometric technology University, Executive for the detection of contaminants), Wave Sciences, LLC Commercialization Advisory Council (innovator in signal processing and officer safety) and 2014, District Chairman, Boy Scouts of TryEco, LLC (inventor of starch based superabsorbent America polymers).

2013 Entrepreneur of the Year, City of Corvallis 2013, Committee of Visitors, National Science Foundation Nicholas F. Fowler, NWMI Chief Executive Officer Statement of Qualifications (Docket No. 50-609-CP) 10

Exhibit NWMI-003 Caroly n C. Haass, NWMI C OO Carolyn C. Haass NWMI Chief Operating Officer Experience Overview Education, Certifications and Affiliations BS, Metallurgical Engineering and Ms. Haass is a senior executive with 30 years of Chemistry, Colorado School of Mines, experience in multidisciplinary complex nuclear, 1984 chemical, hazardous, and mixed-waste engineering, procurement, construction, and project management Years of Experience projects for both government and private industry. She 33 years (total) served as a regulator with the U.S. Department of Energy 25 years at DOE sites for more than 10 years. Ms. Haass expertise includes 6 years working with NRC strategic planning and project management of large 7 years radioisotopes production complex nuclear and hazardous waste projects; technology development, project design, construction, Work History and operations; developing long-term life-cycle 2012 - present, Northwest Medical technical, schedule, and cost integrated baselines; and Isotopes, LLC associated risk and issue management. She has extensive 1997 - 2012, Various Hanford Site communications experience in the nuclear and contractors environmental industry, including day-to-day interface 1991 - 1997, U.S. Department of with regulators, safety boards, Congress, stakeholders, Energy tribal nations, public, media, community leaders, and 1985 - 1991, Ebasco, Inc. decision makers.

Relevant Highlights Relevant Project Experience Direct management responsibility for Northwest Medical Isotopes, LLC (NWMI) -

more than $150M of task-based Corvallis, OR 2012 - present projects for commercial and Chief Operating Officer (COO) government nuclear projects Extensive experience in systems COO and co-founder of NWMI with the charge to design, license, construct and operate a medical engineering, assessments, alternative radioisotope production facility. Lead and direct all evaluations, system optimization, and company operations, strategic planning, business flowsheet development development and conflict management with 100+

Responsible for 100+-person, multi- employees and contract staff. Establish and maintain organizational project team, Hanford operating standards, regulatory compliance, and total Tank Farm Pretreatment Project quality management while maintaining a current level of Managed and completed two EISs for knowledge of industry-related trends and compliance the Hanford Nuclear Reservation, standards to ensure a cohesive structure within the including Tank Farms and K-Basins company.

Direct management responsibility for Consultant, URS Corporation/AECOM and all environmental requirements, Fluor Corporation - Richland, WA 2001 - 2012 Hanford Tank Farms Consultant Member of the White House Office of Supported the Hanford River Protection Project (RPP) in Science & Technology Policy strategic planning and the development of new Committee on the Supply of Medical technologies for the cleanup of Hanford tank waste.

Radionuclides Developed business strategies/plans for environmental Council of Radionuclides and cleanup for DOE sites, including Hanford, Idaho, and Radiopharmaceuticals Board Member Savannah River.

Paul Harris Fellow (X4), Rotary International Carolyn C. Haass, NWMI Chief Operating Officer Statement of Qualifications (Docket No. 50-609-CP) 11

Exhibit NWMI-003 Environmental Compliance and Permitting Manager Aqueous Separations Engineering Scale Demonstration Facility (ASESDF) project, Idaho National Engineering and Environmental Laboratory - Supported development of an integrated baseline, including technical, cost, schedule, and environmental strategy required for the design, construction, and commissioning of ASESDF. The ASESDF project involved the design-construction of an engineering-scale demonstration of light water reactor (LWR) fuel preparation and leaching, subsequent aqueous separations, and solidification processes. Responsibilities included compliance with RCRA, CAA, CWA, NEPA, and waste incidental to reprocessing (WIR) determination for first cycle raffinates.

Technical Advisor U.S. Department of Defense (DoD) Chemical Demilitarization/DOE High-Level Tank Waste Treatment -Supported and advised technology development, design, fabrication, commissioning, and testing of processes and equipment; conduct of operations; and ESH&Q projects for the treatment of legacy waste in DoD (chemical demilitarization projects) and DOE Environmental Management (high-level tank waste treatment).

Portage, Inc. - Richland, WA 2001 - 2003 Office Manager Responsibilities included development of operations business plan to win and maintain a work backlog of more than $12 million annually for governmental environmental restoration activities, managed over 25 technical and administrative personnel, and procured contracts for both small and large contracts and for all types of contracting mechanisms. Negotiated contract requirements, ensured contract compliance, and completed performance evaluations.

Technical Advisor Yucca Mountain Environmental Impact Statement (EIS) - Supported preparation and submission of Yucca Mountain EIS for the storage of commercial nuclear power plant spent fuel and immobilized high-level waste generated during the cold war era at DOE sites.

CH2M HILL Hanford Group, Inc. - Richland, WA 1997 - 2001 Regulatory/Stakeholder and Congressional Affairs Director, DOE Hanford Tank Farms Supported efforts to cleanup ~56 Mgal of mixed radioactive and hazardous waste in the Hanford tank farms. Responsibilities include:

• Served as principal liaison between regulatory agencies, stakeholders (Federal Facility Agreement and Consent Orders), congressional staff, media, and community leaders for the Hanford tank farms and associated prime contractors

• Developed, led, and integrated ES&H/regulatory, stakeholder, and congressional strategies and issues to ensure project success; consistent and effective communications were maintained to validate strategic mission objectives; and regulatory requirements were being met

• Maintained direct communication with all levels of management, including company presidents and Senior DOE officials

• Managed and provided oversight of media relationships and events

• Developed/maintained relationships with Federal, State, and local officials and community leaders

• Served on the DOE Emergency Operations/Response Team.

Director, Single Shell Tank (SST) Program and Balance of Mission Strategic Planning Managed program and strategic planning for tank waste retrieval and closure of 149 underground SSTs that contain approximately 40 Mgal of high-level radioactive mixed waste. Project life-cycle costs were estimated to be ~$12-15 billion over 40 years. Specific responsibilities include:

• Formulated strategic plans to meet SST mission closure goals and objectives (e.g., waste retrieval technology development, tank waste retrieval upgrades, risk-based waste retrieval, RCRA closure (seven waste management units)

• Developed project execution plans and project management plans Carolyn C. Haass, NWMI Chief Operating Officer Statement of Qualifications (Docket No. 50-609-CP) 12

Exhibit NWMI-003

• Developed life-cycle cost estimates and managed the allocation and prioritization of financial resources to meet mission requirements

• Conducted RCRA remedial investigations to determine the nature and extent of contamination in support of corrective measure studies for all environmental media (e.g., soil, groundwater)

• Implemented project management requirements (e.g., monthly project performance reporting, earned value management system [EVMS], risk management, staffing/human resources)

• Negotiated and monitored over 20 subcontracts (ranging from $100,000 to $5 million)

U.S. Department of Energy (Richland, WA) 1991 - 1997 Environmental/NEPA Manager, Hanford Tank Farms

• Managed and integrated environmental activities for Hanford tank farms remediation activities, including permitting (RCRA, CWA, CAA), NEPA, regulatory compliance and interface, public involvement/communication, and strategic planning

• Managed and completed 2 EISs and supported development of four additional EISs, and managed completion of 12 environmental assessments (EA) and more than 25 categorical exclusion (CX) determinations for execution of the Hanford cleanup mission

• Developed and implemented communication and public involvement activities

• Maintained strategic interface relationships with key Federal and State decision-makers, congress, stakeholders, tribal nations and media Pretreatment Facility/Construction Project Acquisition Manager, Hanford Tank Farms

• Managed and oversaw all tank waste infrastructure projects acquisitions (tank farms upgrades and line items) and the initial pretreatment module (pretreatment of Hanford tank waste) supporting the tank waste remediation system (TWRS) mission

• Responsibilities included day-to-day management of project planning, design, and construction activities, including baseline and technical management, contract management and procurement, and life-cycle cost and schedule analysis. Project life-cycle costs were in excess of $1 billion.

EBASCO, Inc. (Lakewood, Co) 1985 - 1991 Project Engineer, DoD Rocky Mountain Arsenal Responsible for several projects that were part of a series of multidisciplinary tasks conducted to assess the nature and extent of contamination resulting from over 40 years of various chemical-manufacturing plants. Contaminants included chemical warfare agents, organic solvents, heavy metals, and pesticides. Also:

• Supported development and submission of RCRA remedial investigation for soil and groundwater contamination caused by leaking chemical sewers and contaminated sanitary sewers

• Evaluated and upgraded wastewater treatment system for the removal of organics, pesticides, and fluorides to come into compliance with Federal and State NPDES permit requirements.

Carolyn C. Haass, NWMI Chief Operating Officer Statement of Qualifications (Docket No. 50-609-CP) 13

Exhibit NWMI-003 Steve Reese, PhD Steve Reese, PhD Irradiation Services Manager Experience Overview Education, Certifications and Affiliations PhD, Radiological Health Sciences, Steve Reese is the Director of the Oregon State Colorado State University, 1997 University (OSU) Radiation Center and instructor in the BS, General Science, Department of Nuclear Engineering and Radiation Health Physics. The OSU Radiation Center is a Oregon State University, 1991 multifaceted research facility specializing in research Years of Experience related to the nuclear sciences. The facility houses 22 years (total) unique capabilities, including the 1.1 MW Oregon State 19 years in research reactor TRIGA reactor (OSTR), gamma irradiator, thermal operations hydraulics testing laboratories, radiochemistry 2 years research scientist at DOE site laboratories, and extensive radiological spectral and counting equipment. His research focus includes neutron Work History radiography, Monte Carlo N-Particle (MCNP) code, 1997 - present, Oregon State isotope production, and reactor dosimetry.

University Dr. Reese also holds a Senior Reactor Operating license 1991 - 1993, PNNL for the OSTR. He is certified by the American Board of Relevant Highlights Health Physics and is a member of the Organization of For the last 12 years, Level 2 for Training, Research, and Test Reactor Executive NRC License R-106, as the Director of Committee. Previously, Dr. Reese served as the Reactor the OSU Radiation Center Administrator of the OSTR for seven years. Prior to that, Responsible for 20-year license he served as a Research Scientist at Battelle Pacific renewal, including writing the safety Northwest National Laboratory. Research activities at analysis report, for NRC License R-106 Battelle centered on development of a CR-39 automated counting system for low-energy neutron environments Project coordinator for the and responsibility for nuclear accident dosimetry conversion from HEU to LEU for technical evaluations and measurements.

license R-106, including safety and accident analyses He has served on several committees that involve reactor Extensive experience in research operations, utilization, and safety. With respect to safety, reactor operations, including holding he currently holds positions on the Reactor Safety Senior Reactor Operators license for Committee for Reed College, serving as the chairperson from 2006-2008, and the Reactor Operations Committee 18 years, implementation of the for the OSTR. These committees perform audits of 10 CFR 50.59 change process, and reactor operations, maintenance and surveillance management responsibility for the schedules, emergency planning, Title 10, Code of emergency response plan, physical Federal Regulations, Part 50.59 (10 CFR 50.59) screens security plan, and operator and evaluations, radiation protection, and experiment requalification plan review and approval.

Author of numerous peer-reviewed publications on neutron Dr. Reese has extensive regulatory and license experience. He was responsible for the coordination, radiography, special nuclear submission, and review of a 20-year NRC reactor license materials detection, reactor renewal application and a safety analysis report in support operation, skin dosimetry, reactor of conversion from high-enriched uranium (HEU) fuel to dosimetry, and numerical modelling low-enriched uranium (LEU) fuel, both of which were of research reactors successfully granted/approved in 2008. Additionally, he has a thorough understanding of the process for making modifications to a facility under 10 CFR 50.59.

Steve Reese, PhD Statement of Qualifications (Docket No. 50-609-CP) 14

Exhibit NWMI-003 Reflective of his recognized expertise in research reactor operations, Dr. Reese has served on several federal advisory committees and was requested as a technical expert on several International Atomic Energy Agency (IAEA) missions to support workshops, meetings, or consultancies. He is also active in Test Research and Training Reactors (TRTR), Health Physics Society (HPS), American Nuclear Society (ANS), and American National Standards Institute (ANSI), where he serves on the Research and Advanced Reactor Consensus Committee and is the working group chairperson for two national standards.

Selected Publications Schickler, R.A., and Reese, S.R., 2017, Installation of a Second CLICIT Irradiation Facility at the Oregon State TRIGA Reactor, 2017 International Group on Research Reactors Annual Meeting, Sydney, Australia.

Marcum, W.R., Byfield, P.Y., and Reese, S.R., 2015, Steady State Thermal Hydraulic Analysis of a Molybdenum Production Element for Implementation in TRIGA Reactors, Nuclear Sci and Engr 180, 123-140.

Schickler, R.A., Marcum, W.R., and Reese, S.R., 2013, Comparison of HEU and LEU Neutron Spectra in Irradiation Facilities at the Oregon State TRIGA Reactor, Nuclear Engr and Design 262, 340-349.

Hartman, M.R., Keller, S.T., Reese, S.R., Robinson, B., Stevens, J., Matos, J.E., Marcum, W.R., Palmer, T.S., and Woods, B.G., 2013, Neutronic Analysis of the Oregon State TRIGA Reactor in Support of Conversion from HEU to LEU Fuel, Nuclear Sci and Eng 174, 135-149.

Hamby D.M., Lodwick, C.J., Palmer, T.S., Reese, S.R., Higley, K.A., Caffrey, J.A., Sherbini, S.,

Saba, M., and Bush-Goddard, S.P., 2013, The New VARSKIN 4 Photon Skin Dosimetry Model, Rad Prot Dosimetry, 154(3), 365-363.

Marcum, W.R., Palmer, T.S., Woods, B.G., Keller, S.T., Reese, S.R. and Hartman, M.R., 2012, A Comparison of Pulsing Characteristics of the Oregon State University TRIGA Reactor with FLIP and LEU Fuel, Nuclear Sci and Eng 171, 150-164.

Hamby, D.M., Lodwick, C.J., Palmer, T.S., Reese, S.R., and Higley, K.A., 2011, VARSKIN 4: A computer Code for Skin Contamination Dosimetry, NUREG/CR-6918, U.S. Nuclear Regulatory Commission, Washington, D.C.

Campbell, L., Misner, A., Smith, L.E., Reese, S.R., Robinson., J.A., 2010, High Energy Delayed Gamma Spectroscopy for Plutonium Assay of Spent Fuel, IAEA-CN-184/128, International Atomic Energy Agency, Vienna, Austria.

Marcum, W.R., Woods, B.G., and Reese, S.R., 2010, Experimental and Theoretical Comparison of Fuel Temperature and Bulk Coolant Characteristics in the Oregon State TRIGA Reactor during Steady State Operation, Nuclear Engr and Design 240, 151-159.

Robinson, J.A., Hartman, M.R., and Reese, S.R., 2010, Design, Construction and Characterization of a Prompt Gamma Activation Analysis Facility at the Oregon State University TRIGA Reactor, J Radioanal Nucl Chem 283, 359-369.

Ashbaker, E., Reese, S.R. and Greenwood, L., 2005, Characterization of the Neutron Spectra in Various Oregon State University TRIGA Reactor Irradiation Facilities, Health Physics 89, 74-75.

Steve Reese, PhD Statement of Qualifications (Docket No. 50-609-CP) 15