ML17363A409
| 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) | |
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Exhibit NWMI-003 Roy W. Brown Statement of Qualifications (Docket No. 50-609-CP) 1 Education, Certifications and Affiliations MA, Business Administration, Webster University, 1987 BS, Radiation Biophysics, University of Kansas, 1978 Years of Experience 39 years total 30+ years in the nuclear medicine industry 9+ years in Health Physics, EHS Work History 2011present, VP, Government Affairs & Strategic Alliances, Curium Pharmaceuticals (and predecessor companies) 20052011, President, Nuclear Medicine Solutions, Inc. 20022005, President, TCI Medical Inc. 20002002, Consultant 19782000, Various positions, Mallinckrodt Relevant Highlights Serves on the European Observatory Working Group on Global Research Reactor Scheduling Member of the White House Office of Science & Technology Policy Committee on the Supply of Medical Radionuclides Serves on several IAEA Coordinated Research Projects on the production of Mo-99, and the Conversion from HEU to LEU for the production of Medical Radionuclides. Served on the Department of Energy Nuclear Science Advisory Committee on Isotopes from 2008-2009 and 2014-2015. Serves on the Board of Directors for the Education & Research Foundation for Nuclear Medicine Roy W. Brown Roy W. Brown Curium, VP, Government Affairs & Strategic Alliances Experience Overview Roy Brown has more than 30 years of experience in the nuclear medicine industry. He currently serves as the co-Chair of the Council on Radionuclide and Radiopharmaceuticals, Inc. (CORAR) Isotope Supply Committee and as the Chairman of the Board for CORAR. He is a member of the Society of Nuclear task force on molybdenum-99 (99Mo), is CuriumAssociation Organization for Economic Cooperation and Development (OECD) Committee on Medical Isotope Supply, serves on the White House Office of Science & Technology Policy Committee on the Supply of Medical Radionuclides, is a member of the European Commission Observatory on the Supply of Medical Isotopes, serves on several International Atomic Energy Agency (IAEA) committees dealing with 99Mo and 133Xe production, is on the European-based Association of Imaging Producers and Imaging Suppliers (AIPES) Reactor and Isotopes Working Group, and serves on the AIPES General Assembly. Mr. Brown currently serves as the Vice President of Government Affairs & Strategic Alliances for Curium. manufacturer, with manufacturing plants in Maryland Heights, Missouri; Petten, Netherlands; and Saclay, France. Curium holds a broad-scope license for its operation in Maryland Heights. The company also has a bulk 99Mo manufacturing plant in the Netherlands. Mr. Browns principal responsibility is development of the -term radionuclide supplies, including 99Mo. He also engages with state and federal legislators, regulatory agencies, and trade associations to educate and advocate on behalf of Curium. Selected Presentations Current Tc-99m Supply Chain Issues and the Effect that LEU Conversion Has Had on the Supply, The Missouri Valley Chapter of SNM Annual Meeting, Overland Park, Kansas, September 16, 2017. Challenges and Opportunities on the Path to LEU Conversion U.S. Department of Energy Mo-99 Topical Symposium Meeting, Montreal, Canada, September 11.
Exhibit NWMI-003 Roy W. Brown Statement of Qualifications (Docket No. 50-609-CP) 2 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. 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. 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. 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. , 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.
Exhibit NWMI-003 Ralph A. Butler, PE Statement of Qualifications (Docket No. 50-609-CP) 3 Education, Certifications, and Affiliations MS, Nuclear Engineering, University of Missouri Columbia BS, Engineering Management, University of Missouri Rolla U.S. NRC Senior Reactor Operator License (30560), Westinghouse PWR Registered Professional Engineer, Missouri (E-20909) Member, American Nuclear Society, since 1983 Past Chair of the National Organization of Test, Research, and Training Reactors (TRTR) Years of Experience 48 years (total) 35+ years of nuclear experience Work History 2000 2017, MURR 1993 2000, DOE/DoS 1989 1992, Consultant (commercial nuclear power) 1981 1989, Union Electric Company 1969 1975, US Navy Relevant Highlights Registered professional engineer (PE) Former NRC licensed Senior Reactor Operator Served on American Nuclear Society Executive Committees for several ANS divisions Awards Recipient, Missouri Honor Award for Distinguished Service in Engineering, University of Missouri College of Engineering, 2008 Recipient (two times), VP Al Gore's National Performance Review Certificate of Appreciation (Hammer Award) Paul Harris Fellow, Rotary International Ralph A. Butler, PE Ralph A. Butler, PE NWMI Senior Advisor Experience Overview Ralph Butler, PE, has over 35 years of nuclear experience in the management, oversight, and operation of Navy, commercial, university, and U.S. Department of Energy (DOE) facilities, both domestic and international. His experience includes power plant and research reactor operations, program management, quality improvement and assessment activities, and independent safety reviews. Mr. Butler is currently serving as a Senior Advisor to Northwest Medical Isotopes, LLC (NWMI) on the licensing and final design of the Radioisotope Production Facility to be constructed in Columbia, Missouri, near the University of Missouri Research Reactor (MURR). Relevant Project Experience University of Missouri Research Reactor Center, Columbia, MO 2000 2017 Executive Director Responsible for the safe, legal, and efficient operation of MW research reactor (MURR), the most powerful university-operated research reactor in the U.S. with a staff of 180. MURR is a multidisciplinary research center with a three-fold mission of promoting interdisciplinary research, providing an education opportunity for students, and providing irradiation and isotope production services to researchers, medical institutions, and private companies worldwide. U.S. Department of Energy (DOE) and Department of State (DoS), Washington, DC 1993 2000 Program Manager, Argonne National Laboratory Maryland office. Program Manager, DOE Office of Nonproliferation and National Security Managed special nuclear material protection, control, and accounting upgrades at four Russian nuclear institutes. Senior Technical Advisor, DoS Advised on matters related to two light water reactors being provided to the Government of the Democratic f Korea, North Korea.
Exhibit NWMI-003 Ralph A. Butler, PE Statement of Qualifications (Docket No. 50-609-CP) 4 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. 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 MechLeading Petty Officer.
Exhibit NWMI-003 Michael R. Corum Statement of Qualifications (Docket No. 50-609-CP) 5 Education, Certifications and Affiliations MS, Nuclear Engineering, University of Tennessee, 1991 BS, Nuclear Engineering, University of Tennessee, 1990 BA, Biology, University of Tennessee, 1981 Years of Experience 36 years (total) 27 years in the nuclear industry Work History 2001 Present, Atkins (member of SNC Lavalin Group) 1982 2001, Various companies Relevant Areas of Expertise Nuclear criticality safety Radiation shielding Packaging and transportation Safety analysis report for packaging (SARP) development Hazardous analysis Reactor core reload analysis Integrated safety analysis Fault tree analysis Qualitative and quantitative methods of hazards assessment Michael R. Corum Michael R. Corum Atkins Vice President, Energy (Nuclear) Experience Overview Michael (Mike) Corum is a subject matter expert with over 27 years of experience in the nuclear industry. His broad experience base in nuclear criticality safety includes expertise in radiation shielding, hazards analysis, packaging and transportation, and core reload analysis. He has extensive experience in both facility support and packaging and transportation (fresh and spent fuel). Additional areas of expertise include integrated safety analysis (ISA), fault tree analysis, qualitative and quantitative methods of hazards assessment, shielding analysis using Monte Carlo N-Particle (MCNP) code, validation and benchmarking of criticality codes, nuclear reactor core design, and reactor physics calculations in support of reload safety analysis efforts. Mr. Corum is an experienced user of MCNP, KENO V.a, KENO VI, the SCALE system (including SAS and CSAS sequences), PHOENIX, and the Advanced Nodal Code (ANC). Since 2012, Mr. Corum has supported Northwest Medical Isotopes, LLC (NWMI) during development of the construction permit and operating license applications for the NWMI Radioisotope Production Facility (RPF). He also provided regulatory support during Advisory Committee on Reactor Safeguards (ACRS) meetings for the construction permit application. His support includes subject matter expertise in criticality safety, shielding, and ISA. In 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.
Exhibit NWMI-003 Michael R. Corum Statement of Qualifications (Docket No. 50-609-CP) 6 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.
Exhibit NWMI-003 Michael R. Corum Statement of Qualifications (Docket No. 50-609-CP) 7 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) 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 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 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 st Combat Evaluation Group.
Exhibit NWMI-003 Gary Dunford Statement of Qualifications (Docket No. 50-609-CP) 8 Education, Certifications and Affiliations BS, Chemical Engineering, University of North Dakota, 1978 Years of Experience 38 years (total) 38 years at DOE sites 31 years in waste retrieval technologies at DOE sites Work History 2001 present, AEM Consulting LLC 1997 2001, WASTREN, Inc. 1979 2001, Various Hanford Site M&O contractors Relevant Highlights Direct management responsibility for more than $25M of task-based projects for Hanford tank farms, most involved preparing or contributing to technical studies and reports related to Hanford waste retrieval and processing 10 years of experience with all aspects of day-to-day Hanford tank farms operations, including waste retrieval and transfer operations Key participant in the development of new process models to support baseline case planning for the Hanford River Protection Project mission Responsible for a 60-person, multi-organizational project team assigned to complete the Tank Waste Remediation System Final Safety Analysis Report, and to communicate the results to regulators and the public Extensive experience in systems engineering, assessments, alternative evaluations, system optimization, and flowsheet development Gary Dunford Gary Dunford AEM Consulting, LLC Managing Partner Experience Overview Gary Dunford has a strong background in plant operations and providing process engineering support to radioactive/mixed waste facilities. His experience extends into systems engineering applications, flowsheet development, conduct of operations principles, operational readiness activities, safety documentation preparation, and authorization basis implementation. Mr. Dunford is noted for his ability to identify innovative solutions to problems and bring diverse groups together to complete projects. He has worked on projects and is familiar with the various sites within the U.S. Department of Energy (DOE) complex, including the Hanford Site, Idaho National Laboratory, and Savannah River Site. Mr. Dunford serves as the AEM Consulting, LLC (AEM) Process Engineering Manager supporting Northwest Medical Isotopes, LLC (NWMI), with responsibility for developing the radiochemical separation processes, developing flowsheet conditions, and sizing of process equipment for the NWMI Radioisotope Production Facility. Tasks include preparing process flow diagrams, piping and instrumentation drawings, and process descriptions. He also provides operations and maintenance and a safety analysis perspective to NWMI. Mr. Dunford served as the Assistant Manager for Facility Operations and was responsible for the daily operations of the Hanford tank farms and readiness activities for special activities and projects. Additionally, his staff successfully installed the Tank SY-101 mixer pump, time. Mr. Dunford served as the Manager of Tank Farms Plant Engineering, a role that had him overseeing a multidisciplined engineering organization responsible for the plant, process, and design engineering functions for tank farms, grout, and evaporator facilities. He was responsible for upgrades to ensure that major modifications were properly designed, safely installed, formally tested, and systematically turned over, including operational readiness activities. Mr. Dunford developed, marketed, and implemented a first DOE Order-compliant final safety analysis report. He implemented a prototype risk status and review Exhibit NWMI-003 Gary Dunford Statement of Qualifications (Docket No. 50-609-CP) 9 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, 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 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 supervisory assignments to support Hanford 200 Area processing facilities.
Exhibit NWMI-003 Nicholas F. Fowler, NWMI Chief Executive Officer Statement of Qualifications (Docket No. 50-609-CP) 10 Education, Certifications and Affiliations M.S., Industrial Engineering and Engineering Management, Stanford University, 1981 B.A., Economics, Stanford University, 1980 Years of Experience 36 years (total) 30 years in executive management 13 years as Chief Executive Work History 2010 present, Northwest Medical Isotopes, LLC 2004 present, Orion Ventures, LLC 1981 2005, Hewlett Packard Company Honors/Affiliations 2014 present, Oregon State University, Executive Commercialization Advisory Council 2014, District Chairman, Boy Scouts of America 2013 Entrepreneur of the Year, City of Corvallis 2013, Committee of Visitors, National Science Foundation Nicholas F. Fowler, NWMI CEO Nicholas F. Fowler NWMI Chief Executive Officer Experience Overview Nicholas Fowler is a serial entrepreneur, active angel investor, and technology industry veteran. He currently serves as Chairman and Chief Executive Office of Northwest Medical Isotopes, LLC (NWMI). Mr. Fowler co-founded NWMI in 2010 with a primary mission to provide a domestic, secure, and reliable supply of molybdenum-99 (99Mo) for medical diagnostics for ailments such as cancer, heart disease, and bone and kidney disease. Beginning in 1981, Mr. Fowler spent 25 years with the Hewlett-Packard Company. As Director and General Manager, he led the creation of several major new businesses, including notebook computers, personal digital assistants, and internet sales and support. Mr. Fowler was the founder or instrumental in the growth of numerous startup ventures, including Perpetua Power Source Technologies, Inc. (a world leader in thermoelectric technologies), ZAPS Technologies, Inc. (an innovator in optical spectrophotometric technology for the detection of contaminants), Wave Sciences, LLC (innovator in signal processing and officer safety) and TryEco, LLC (inventor of starch based superabsorbent polymers).
Exhibit NWMI-003 Carolyn C. Haass, NWMI Chief Operating Officer Statement of Qualifications (Docket No. 50-609-CP) 11 Education, Certifications and Affiliations BS, Metallurgical Engineering and Chemistry, Colorado School of Mines, 1984 Years of Experience 33 years (total) 25 years at DOE sites 6 years working with NRC 7 years radioisotopes production Work History 2012 present, Northwest Medical Isotopes, LLC 1997 2012, Various Hanford Site contractors 1991 1997, U.S. Department of Energy 1985 1991, Ebasco, Inc. Relevant Highlights Direct management responsibility for more than $150M of task-based projects for commercial and government nuclear projects Extensive experience in systems engineering, assessments, alternative evaluations, system optimization, and flowsheet development Responsible for 100+-person, multi-organizational project team, Hanford Tank Farm Pretreatment Project Managed and completed two EISs for the Hanford Nuclear Reservation, including Tank Farms and K-Basins Direct management responsibility for all environmental requirements, Hanford Tank Farms Member of the White House Office of Science & Technology Policy Committee on the Supply of Medical Radionuclides Council of Radionuclides and Radiopharmaceuticals Board Member Paul Harris Fellow (X4), Rotary International Carolyn C. Haass, NWMI COO Carolyn C. Haass NWMI Chief Operating Officer Experience Overview Ms. Haass is a senior executive with 30 years of experience in multidisciplinary complex nuclear, chemical, hazardous, and mixed-waste engineering, procurement, construction, and project management projects for both government and private industry. She served as a regulator with the U.S. Department of Energy for more than 10 years. Ms. Haass expertise includes strategic planning and project management of large complex nuclear and hazardous waste projects; technology development, project design, construction, and operations; developing long-term life-cycle technical, schedule, and cost integrated baselines; and associated risk and issue management. She has extensive communications experience in the nuclear and environmental industry, including day-to-day interface with regulators, safety boards, Congress, stakeholders, tribal nations, public, media, community leaders, and decision makers. Relevant Project Experience Northwest Medical Isotopes, LLC (NWMI) Corvallis, OR 2012 present Chief Operating Officer (COO) COO and co-founder of NWMI with the charge to design, license, construct and operate a medical radioisotope production facility. Lead and direct all company operations, strategic planning, business development and conflict management with 100+ employees and contract staff. Establish and maintain operating standards, regulatory compliance, and total quality management while maintaining a current level of knowledge of industry-related trends and compliance standards to ensure a cohesive structure within the company. Consultant, URS Corporation/AECOM and Fluor Corporation Richland, WA 2001 2012 Consultant Supported the Hanford River Protection Project (RPP) in strategic planning and the development of new technologies for the cleanup of Hanford tank waste. Developed business strategies/plans for environmental cleanup for DOE sites, including Hanford, Idaho, and Savannah River.
Exhibit NWMI-003 Carolyn C. Haass, NWMI Chief Operating Officer Statement of Qualifications (Docket No. 50-609-CP) 12 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 ~$1215 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 Exhibit NWMI-003 Carolyn C. Haass, NWMI Chief Operating Officer Statement of Qualifications (Docket No. 50-609-CP) 13 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.
Exhibit NWMI-003 Steve Reese, PhD Statement of Qualifications (Docket No. 50-609-CP) 14 Education, Certifications and Affiliations PhD, Radiological Health Sciences, Colorado State University, 1997 BS, General Science, Oregon State University, 1991 Years of Experience 22 years (total) 19 years in research reactor operations 2 years research scientist at DOE site Work History 1997 present, Oregon State University 1991 1993, PNNL Relevant Highlights For the last 12 years, Level 2 for NRC License R-106, as the Director of the OSU Radiation Center Responsible for 20-year license renewal, including writing the safety analysis report, for NRC License R-106 Project coordinator for the conversion from HEU to LEU for license R-106, including safety and accident analyses Extensive experience in research reactor operations, including holding Senior Reactor Operators license for 18 years, implementation of the 10 CFR 50.59 change process, and management responsibility for the emergency response plan, physical security plan, and operator requalification plan Author of numerous peer-reviewed publications on neutron radiography, special nuclear materials detection, reactor operation, skin dosimetry, reactor dosimetry, and numerical modelling of research reactors Steve Reese, PhD Steve Reese, PhD Irradiation Services Manager Experience Overview Steve Reese is the Director of the Oregon State University (OSU) Radiation Center and instructor in the Department of Nuclear Engineering and Radiation Health Physics. The OSU Radiation Center is a multifaceted research facility specializing in research related to the nuclear sciences. The facility houses unique capabilities, including the 1.1 MW Oregon State TRIGA reactor (OSTR), gamma irradiator, thermal hydraulics testing laboratories, radiochemistry laboratories, and extensive radiological spectral and counting equipment. His research focus includes neutron radiography, Monte Carlo N-Particle (MCNP) code, isotope production, and reactor dosimetry. Dr. Reese also holds a Senior Reactor Operating license for the OSTR. He is certified by the American Board of Health Physics and is a member of the Organization of Training, Research, and Test Reactor Executive Committee. Previously, Dr. Reese served as the Reactor Administrator of the OSTR for seven years. Prior to that, he served as a Research Scientist at Battelle Pacific Northwest National Laboratory. Research activities at Battelle centered on development of a CR-39 automated counting system for low-energy neutron environments and responsibility for nuclear accident dosimetry technical evaluations and measurements. He has served on several committees that involve reactor operations, utilization, and safety. With respect to safety, he currently holds positions on the Reactor Safety Committee for Reed College, serving as the chairperson from 20062008, and the Reactor Operations Committee for the OSTR. These committees perform audits of reactor operations, maintenance and surveillance schedules, emergency planning, Title 10, Code of Federal Regulations, Part 50.59 (10 CFR 50.59) screens and evaluations, radiation protection, and experiment review and approval. Dr. Reese has extensive regulatory and license experience. He was responsible for the coordination, submission, and review of a 20-year NRC reactor license renewal application and a safety analysis report in support of conversion from high-enriched uranium (HEU) fuel to low-enriched uranium (LEU) fuel, both of which were 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.
Exhibit NWMI-003 Steve Reese, PhD Statement of Qualifications (Docket No. 50-609-CP) 15 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 2017 International Group on Research Reactors Annual Meeting, Sydney, Australia. Marcum, W.R., Byfield, P.Y., and Reese, S.R., 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, 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, he 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., 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, 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, computer Code for Skin Contamination Dosimetry,-6918, U.S. Nuclear Regulatory Commission, Washington, D.C. Campbell, L., Misner, A., Smith, L.E., Reese, S.R., Robinson., J.A., 2010, Gamma Spectroscopy for Plutonium Assay of Spent Fuel,-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 OperationNuclear Engr and Design 240, 151-159. Robinson, J.A., Hartman, M.R., and Reese, S.R., 2010, 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, haracterization of the Neutron Spectra in Various Oregon State University TRIGA 89, 74-75.