Text

Meeting Slides for the May 26, 2016 Public Meeting Between Shine Medical Technologies, Inc., and the NRC
	ML16139A593
Person / Time
Site:	SHINE Medical Technologies
Issue date:	05/18/2016
From:	Bartelme J; SHINE Medical Technologies
To:	; Document Control Desk, Office of Nuclear Reactor Regulation
References
	SMT-2016-034
	Download: ML16139A593 (37)
	v • d • e

May 18, 2016 SMT-2016-034 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555

References:

(1) U.S. Nuclear Regulatory Commission, "SHINE Medical Technologies, Inc.

Discussion on Eligible Facilities List and Construction Inspection,"

Meeting Notice, May 11, 2016 (ML16133A094)

Meeting Slides for the May 261h, 2016 Public Meeting between SHINE Medical Technologies. Inc. and the NRC A meeting is scheduled between SHINE Medical Technologies, Inc. (SHINE) and the NRC staff to discuss SHINE's addition to the U.S. Eligible Facilities List and to discuss topics related to construction inspection (Reference 1). provides the SHINE meeting slides.

If you have any questions, please contact me at 608/210-1735.

Very truly yours, Jeff Bartelme Licensing Manager SHINE Medical Technologies, Inc.

Docket No. 50-608 Enclosure cc: Administrator, Region Ill, USNRC Project Manager, USNRC Environmental Project Manager, USNRC Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health 2555 Industrial Drive I Monona, WI 53713 IP (608) 210-1060 IF (608) 210-2504 I www.shinemed.com

ENCLOSURE 1 SHINE MEDICAL TECHNOLOGIES, INC.

MEETING SLIDES FOR THE MAY 26TH, 2016 PUBLIC MEETING BETWEEN SHINE MEDICAL TECHNOLOGIES, INC. AND THE NRC 35 pages follow

Discussion on Eligible Facilities List and Construction Inspection May 26, 2016

SHINE Medical Technologies, Inc.

Dedicated to being the world leader in safe, clean, affordable production of medical tracers and cancer treatment elements.

Leading efforts to establish U.S.

fission-based medical isotope supply that will fill the gap in supply chain caused by exiting foreign reactors.

Highest priority is safely delivering a highly reliable, high-quality supply of medical isotopes that are required by nearly 100,000 patients globally each day, while maintaining a minimal environmental impact.

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Medical Isotopes Molybdenum-99 (Mo-99), the most widely-used medical isotope, decays into technetium-99m, which is used in more than 40 million doses annually Mo-99 cannot be stockpiled, which necessitates a reliable and continuous supply Stress tests and bone scans most common of dozens of uses SHINEs process will also generate iodine-131 and xenon-133 3

Medical Isotope Production and SHINE SHINEs technology and processes have several clear advantages to traditional isotope production methods Accelerator technology replaces nuclear reactor Avoids the use of weapons-grade HEU in a nuclear reactor Reusable liquid target allows for simplified production, recovery, and reusability Radioactivity associated with SHINE process is hundreds of times less than with current medical isotope production processes 4

Site Layout 5

Production Facility Building Layout The SHINE production process consists of an irradiation facility (IF) and a radioisotope production facility (RPF)

The SHINE IF consists of eight subcritical irradiation units (IUs)

The RPF is the portion of the SHINE facility used for:

Preparing target solution; Extracting, purifying, and Irradiation packaging Mo-99; and Facility Radioisotope Recycling and cleaning of Production target solution. Facility 6

General Structural Design Main facility building to withstand external events Seismic (design basis earthquake with 0.2g peak ground acceleration)

Tornado and tornado generated missiles Maximum precipitation and snow load Aircraft impact from the aircraft types that frequent SWRA Preliminary design of structure accommodates these loads with no damage/risk to internal systems Other loads that are typical include dead loads, live loads, wind loads, crane loads, soil pressure loads, liquid loads, and flood loads 7

SHINE Fusion-Fission Process SHINEs Fusion-Fission Coupling An IU consists of a subcritical assembly, a N P neutron driver, and supporting systems D

Major supporting systems include:

Light water pool system (LWPS) T N P N

Neutron Target solution vessel (TSV) off-gas system (TOGS) Driver Primary closed loop cooling system (PCLS) N Neutron Tritium purification system (TPS) Multiplier Primary system at near-atmospheric pressure N N

N Target solution is drained to dump tank via gravity Target Solution Dump tank is criticality-safe by geometry and N N P N

Vessel passively-cooled P N P N N P N P N P N N Redundant, fail-open dump valves P N N P N P N N P N N N TSV is an annular vessel to be constructed of N P N N P U

Zircaloy-4 Natural convection within TSV Radioisotopes in solution 8

SHINE Process Overview 4

5 3

2 6

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1. Target Solution Preparation Target solution prepared from either uranium metal (19.75% enriched) or from recycled uranium oxide Process Uranium metal is converted to uranyl nitrate by dissolution in nitric acid Uranyl nitrate is converted to uranium oxide by the thermal denitration process Uranium oxide is dissolved in sulfuric acid to produce uranyl sulfate target solution Samples are analyzed to ensure uranium concentration and pH meet operating limits Inadvertent criticality prevented through inherent design of equipment (tanks, storage racks, etc.)

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2. Hold Tank One criticality-safe, annular hold tank per TSV Hold tank located below the elevation of the TSV, requiring motive force to move the solution into the TSV Volume limited to liquid fill volume of TSV Samples are analyzed to ensure uranium concentration and pH meet operating limits Valve, pipe, and pump sizing limits the flow rate of solution from the hold tank into the TSV Remains empty during irradiation 11

3. TSV and Irradiation Unit Cell An IU consists of a subcritical assembly, a neutron driver, and supporting TOGS Neutron Driver systems The neutron driver is an electrostatic accelerator with a gas target, creating 14 MeV neutrons from D-T fusion reactions Top of pool Major supporting systems include:

Light water pool system (LWPS) Target Chamber TSV off-gas system (TOGS) of Neutron Driver (Hidden)

Primary closed loop cooling system (PCLS) Subcritical Assembly Support Tritium purification system (TPS) Structure (SASS)

Primary system is at near-atmospheric pressure 12

4. Supercell Mo extraction process Irradiated target solution is passed through a titania column, where the Mo and other fission products are adsorbed onto the titania Mo is then eluted from the column using a base The Mo-bearing solution is dried, re-dissolved with nitric acid, and passed through a second titania column to concentrate the Mo LEU-Modified Cintichem process used to purify the Mo product Product packaging also Extract Purify Package occurs in the supercell 13

5. Recycle Target Solution Tank Post-extraction target solution that will be recycled is transferred to one of three recycle target solution tanks These tanks are located in shielded vaults From here it is transferred to one of the target solution hold tanks Tanks provide buffer capacity for the process 14

6. Target Solution Cleanup:

Uranium Extraction (UREX)

Uranyl nitrate preparation Precipitation of sulfate solids and separation of liquid from solids Solvent extraction process (UREX)

A typical batch requires approximately 4 hours4.62963e-5 days 0.00111 hours 6.613757e-6 weeks 1.522e-6 months to process Solvent is 30 percent by volume TBP in n-dodecane Uranyl nitrate aqueous stream exiting the strip section flows through an anion exchange column which adsorbs the Tc and I Denitration Evaporation of uranyl nitrate Thermal denitration of the liquid to uranium oxide 15

Project Schedule SHINE is starting detailed design of the facility Construction of the production facility building will begin once sufficient design information is available to reduce potential risks of changes Site preparations currently expected early 2017 Operating license (OL) will be prepared once sufficient design information is ready to write the FSAR chapters OL submittal currently planned for mid-2017 Based on review duration estimates provided by the NRC, current scheduled operation of the facility is in late 2019 16

Conclusions SHINE facility operates by using a particle accelerator to drive a subcritical fission target Source term in any confinement area approximately 10,000 times less than a power reactor Decay cooling is passive Production facility building structure designed for protection from external events No containment required nor included Confinement areas protect worker and public health and safety in the event of a design basis accident 17

Design Change Control Process Design change control process is part of the SHINE Configuration Management program The process maintains consistency between Design requirements Physical configuration Facility documentation Implements a portion of the design control requirements of the SHINE QAPD 18

Overview of the Design Change Control Process Process for requesting, screening, evaluating, and approving (or rejecting) design changes Applies only to design changes, not generation of additional details of the design Ensures that design changes receive appropriate technical and management review to:

Ensure safety and environmental impacts are fully understood Assess impacts on the licensing basis and licensing documents Evaluate overall benefits and consequences of the change 19

Design Change Package Consolidates documentation related to a design change Facilitates a more consistent and comprehensive review of the affected documents Ensures the affected documents are updated to be consistent with the design change, such as:

Calculations Technical reports Drawings Licensing basis documentation changes Ensures that design changes are fully implemented prior to closeout 20

Design Change Request

Identify if a proposed activity constitutes a design change Identify Design

Procedurally request a design change Change Request

Design change request is reviewed for safety impacts, completeness, technical accuracy, and initial licensing Review basis effects

Change receives review for approval Approval/

Overall effects of the change are reviewed and it is Rejection approved or rejected 21

Design change package populated with affected documents, Populate including licensing basis review Package

Design change package is reviewed Review

Design change package receives review for approval Approval If Approved If Rejected

Change incorporated into the

Packages are marked as cancelled facility design and licensing

Documents to support the design Implement basis Cancel change are appropriately marked (e.g., cancelled)

Package is verified as complete and closed Close Package 22

Licensing Basis Review Licensing basis is reviewed, including but not limited to:

PSAR, including the Environmental Report SHINE RAI Responses NRC Safety Evaluation Report and Environmental Impact Statement related to Construction Permit (CP)

Markup of changes is developed for incorporation into draft FSAR/as-submitted FSAR Issues Management Report (IMR) is used to track the incorporation of changes into draft FSAR/as-submitted FSAR SHINE CP is reviewed If a change is required, an Amendment Request would be prepared and submitted to the NRC Licensing basis review form is reviewed and approved 23

Conclusions Design change control process ensures that potential deviations from the approved design are appropriately reviewed and approved Effects on safety and the environment Licensing basis effects Overall effects on the facility design, construction, and operation Design change packages consolidate affected documents to facilitate a comprehensive review Change control process ensures that design requirements, physical configuration, and facility documentation remain consistent 24

Inspection Manual Chapter 2550 General Comments SHINE would like clarification on the applicability of the NRCs Construction Inspection Program (CIP) for NPUFs.

Section 2550-01 states, The NPUF CIP applies to all safety related construction activities, including, design, procurement, fabrication, construction, pre-operational testing activities, and development of programs required for operation.

Section 2550-03 states, The NPUF CIP applies to all construction activities, including, the design, procurement, fabrication, construction, and pre-operational testing and operational readiness activities.

Section 2550-06 states, Substantial emphasis is to be placed on the inspection of SSCs that are important to safety.

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Inspection Manual Chapter 2550 General Comments Following Operational Readiness inspections, and the issuance of the Operating License, will SHINE transition to an inspection program similar to IMC 2545, Research and Test Reactor Inspection Program?

Will there be an NPUF Operational Action Matrix similar to the NPUF Construction Action Matrix (Exhibit I) in which SHINE will transition to?

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Inspection Manual Chapter 2550 Section 2550-03, Applicability How will the Commissions current Enforcement Policy for facilities in the construction phase be applied to SHINE?

Subsection 03.03 states, NPUFs will remain within the scope of the Commission's current Enforcement Policy for facilities in the construction phase.

Section 2.2.6, Construction, of the NRC Enforcement Policy references the Changes during Construction (CdC) Process, as developed in ISG-025.

ISG-025, applicable to Part 52 licensees, relies on the preliminary amendment request (PAR) process, which was removed from the SHINE Draft Construction Permit.

The NRCs Enforcement Manual, as it relates to facilities in the construction phase, is specific to reactors. How will the NRC apply the current Enforcement Manual to the SHINE facility during the construction phase?

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Inspection Manual Chapter 2550 Section 2550-04, Definitions The definitions in the IMC are not applicable to the SHINE facility.

The SHINE design does not include IROFS, and the IMC definition of safety-related differs from those definitions in 10 CFR 50.2, ANSI/ANS-15.8, and the SHINE CLB definition.

Will the NRC be inspecting to the SHINE CLB definition of safety-related?

Safety-related SSCs: Those SSCs that are relied upon to remain functional during normal conditions and during and following design basis events to assure:

The integrity of the primary system boundary; The capability to shut down the target solution vessel and maintain the target solution in a safe shut-down condition; The capability to prevent or mitigate the consequences of accidents which could result in potential exposures comparable to the applicable guideline exposures set forth in 10 CFR 20; That all nuclear processes are subcritical, including use of an approved margin of subcriticality; That acute chemical exposures to an individual from licensed material or hazardous chemicals produced from licensed material could not lead to irreversible or other serious, long-lasting health effects to a worker or cause mild transient health effects to any individual located outside the owner controlled area; or That an intake of 30 mg or greater of uranium in soluble form by any individual located outside the owner controlled area does not occur.

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Inspection Manual Chapter 2550 Section 2550-06, Basic Requirements Will the development of the master construction inspection plan be coordinated with SHINE? Will SHINE be allowed an opportunity to review the plan during development?

Subsection 06.02 states, The FSARG will also develop the performance based master construction inspection plan.

What is the content of the master construction inspection plan?

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Inspection Manual Chapter 2550 Section 2550-07, Guidance What is meant by approved design? SHINE interprets this to mean the NRC will inspect to the SHINE-approved final design of the facility?

Subsection 07.02 states, The inspections will also verify that as-built construction meets the approved design.

What is meant by other licensing design commitments? SHINE interprets this to mean the Regulatory Commitments documented in Appendix A of the Safety Evaluation Report related to the SHINE Construction Permit?

Subsection 07.02 states, In addition, the licensees design change and design control process will be reviewed to verify that the design process effectively implements NRC requirements and other licensing design commitments made by the licensee.

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Inspection Manual Chapter 2550 Appendix B, NPUF Construction Inspection Reports Appendix B of IMC 2550 provides direction related to which licensee-identified violations require documenting in the inspection report. Appendix B limits licensee-identified violations to be those identified via a licensee self-assessment or audit. SHINE believes this list is too narrow, and should be expanded to account for issues identified through a SHINE program or process (e.g., QC Inspection).

Section 5.1.a.2 (Page AppB-13) states, Note, finally, that the discussion in this subsection applies to violations identified through licensee audits and self-assessments (i.e., cases in which the NRC's inspection is focused on the licensee's quality assurance efforts), and should not be applied to all licensee-identified violations.

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Inspection Procedure 69020 General Comments How will the NRC provide the Information Needs Request to SHINE?

Will a single Information Needs Request be provided for the entirety of the inspection procedure, or will individual Information Needs Requests be provided for each Appendix?

Will the NRC coordinate with SHINE to determine when an Appendix is ready to be inspected?

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Inspection Procedure 69020 Appendix B, Inspection of Structural Concrete at NPUFs Was the below language meant to guide the inspector in their inspection planning? Is it SHINEs responsibility to notify the NRC of scheduled concrete placement in order to facilitate the inspectors planning, or is it expected that schedule coordination meetings between SHINE and the NRC will allow the inspector to plan accordingly?

Subsection 03.01 states, Before any concrete placement, a specific technical review of concrete-mix designs and supporting material qualifications should be performed. The inspectors should also verify that the batch plant has been inspected and certified before placement of any safety-related concrete.

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Inspection Procedure 69021 Appendix B, Inspection of Requirement 2.2 -

Quality Assurance Program SHINE intends to revise the QAPD as necessary, in accordance with SHINEs Document Control procedure. SHINE will provide the current revision of the SHINE QAPD with the Operating License Application, in order to meet the requirements in 10 CFR 50.34(b)(6)(ii), which requires a description of managerial and administrative controls to be used to ensure safe operation.

Subsection A2.04.02.b states, Examine the most recent revision of the QAPD. Verify that revisions to the QAPD were reviewed and approved in accordance with established requirements.

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Inspection Procedure 69022 Section 69022-02, Inspection Requirements and Guidance Will the NRC make the determination that construction of the SHINE facility is substantially complete, or will SHINE make the determination, and make a notification to the NRC?

Subsection 02.02.a.1 states, The operational readiness inspection should be scheduled after construction is substantially complete, but prior to the issuance of the operating license.

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