ML14120A473
| ML14120A473 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 05/02/2014 |
| From: | Steven Lynch Research and Test Reactors Licensing Branch |
| To: | |
| Lynch S | |
| Shared Package | |
| ML14120A482 | List: |
| References | |
| Download: ML14120A473 (8) | |
Text
May 2, 2014 APPLICANT: SHINE Medical Technologies, Inc.
SUBJECT:
SUMMARY
OF MARCH 19 AND 20, 2014, MEETING WITH SHINE MEDICAL TECHNOLOGIES, INC.
On March 19 and 20, 2014, a series of Category 1 public meetings were held between the U.S.
Nuclear Regulatory Commission (NRC) staff and representatives of SHINE Medical Technologies, Inc. (SHINE) at NRC Headquarters, One White Flint North, 11555 Rockville Pike, Rockville, Maryland. The purpose of these meetings was to discuss the licensing and technical aspects associated with the SHINEs construction permit application. Portions of these meetings were closed to the public to discuss proprietary information related to the specifics of design and operation of SHINEs proposed medical radioisotope production facility. A list of attendees at each meeting is provided as Enclosure 1.
The NRC staff opened the meeting beginning at 9:00 a.m. on March 19, 2014, by emphasizing the importance of communication between SHINE and the NRC. SHINE responded, remarking that it had a positive experience working with the NRC and appreciated the NRCs time and feedback. SHINE then transitioned into a presentation on its proposed facility design changes and the impact these changes would have on its preliminary safety analysis report (PSAR).
SHINE proposed nine changes in order to enhance safety, optimize resources, improve constructability, and facilitate efficient operations and maintenance. SHINEs design changes proposed to eliminate a crane in the supercell area, reduce the height of the radioisotope production facility, reduce the thickness of the of the radioisotope production facilitys roof, relocate the noble gas storage, eliminate a crane in the radioisotope production facility tank farm area, optimize equipment layout in the irradiation facility, resize the irradiation facility crane, relocate bulk chemical storage, and relocate normal switchgear. Further details on this discussion are included in the presentation slides (ADAMS Accession No. ML14070A236).
During the portion of the meeting closed to the public, SHINE went into proprietary-level detail related to the specific design and layout of its proposed design changes. A meeting dedicated to the discussion of security-related information was also held the afternoon of March 19, 2014.
Due to the sensitive nature of material covered in this meeting, it was entirely closed to the public. Discussions during this meeting focused on the development of a safeguards information program and design considerations that could impact the development of SHINEs physical security plan.
On March 20, 2014, two meetings were held to cover discussion topics related to SHINEs irradiation facility and radioisotope production facility, respectively. No formal presentations were made at these meetings; however, the list of discussion topics covered during these meetings has been provided as Enclosure 2. These meetings allowed SHINE to provide additional information on aspects of its application that NRC staff felt required additional clarification. NRC staff used the information provided in these meetings to better inform and develop their formal requests for additional information.
A portion of each of the meetings held on March 20, 2014, were closed to the public to discuss proprietary details of those discussion topics that could not be completely addressed in the open portion of the meeting.
Please direct any inquiries to Steven Lynch at 301-415-1524 or Steven.Lynch@nrc.gov.
/RA/
Steven T. Lynch, Project Manager Research and Test Reactor Licensing Branch Division of Policy and Rulemaking Office of Nuclear Reactor Regulation Docket No. 50-608 : List of Attendees : Discussion Topics cc:
Mr. James Costedio Licensing Manager SHINE Medical Technologies, Inc.
2555 Industrial Drive Monona, WI 53713
Pkg: ML14120A482; Notice: ML14063A588; Summary: ML14120A473 NRC-001 OFFICE DPR/PRLB/PM DPR/PRLB/LA DPR/PRLB/BC DPR/PRLB/PM NAME SLynch PBlechman AAdams SLynch DATE 05/01/2014 05/01/2014 05/01/2014 05/02/2014 LIST OF ATTENDEES MARCH 19, 2014, MEETING WITH SHINE MEDICAL TECHNOLOGIES, INC.
9:00 A.M - 12:00 P.M.
Name Organization Vann Bynum SHINE Medical Technologies, Inc.
Jim Costedio SHINE Medical Technologies, Inc.
Eric Van Abel SHINE Medical Technologies, Inc.
Bill Hennessy SHINE Medical Technologies, Inc.
Katrina Pitas SHINE Medical Technologies, Inc.
Devon Engleman SHINE Medical Technologies, Inc.
Steve Lynch U.S. Nuclear Regulatory Commission Lawrence Kokajko U.S. Nuclear Regulatory Commission Mirela Gavrilas U.S. Nuclear Regulatory Commission Linh Tran U.S. Nuclear Regulatory Commission Alexander Adams U.S. Nuclear Regulatory Commission Mary Adams U.S. Nuclear Regulatory Commission Kimberly Gambone U.S. Nuclear Regulatory Commission Maria Guardiola U.S. Nuclear Regulatory Commission Cassandra Frasier U.S. Nuclear Regulatory Commission Robert Hoffman U.S. Nuclear Regulatory Commission Joan Olmstead U.S. Nuclear Regulatory Commission Michelle Moser U.S. Nuclear Regulatory Commission Larry Harris U.S. Nuclear Regulatory Commission Maitri Banerjee U.S. Nuclear Regulatory Commission Tarek Zaki U.S. Nuclear Regulatory Commission Thomas Boyle U.S. Nuclear Regulatory Commission Victoria Huckabay U.S. Nuclear Regulatory Commission Mitzi Young U.S. Nuclear Regulatory Commission Donna-Beth Howe U.S. Nuclear Regulatory Commission Joseph Staudenmeier U.S. Nuclear Regulatory Commission Matthew Panicker U.S. Nuclear Regulatory Commission J. Stewart Bland Chesapeake Nuclear Thomas Essig Chesapeake Nuclear Terry Gitnick Information Systems Labs Inc.
Diane Mlynarczyk Information Systems Labs Inc.
Abe Weitzberg Information Systems Labs Inc.
Greg Hofer Information Systems Labs Inc.
Dan Cronin University of Florida Enclosure 1
LIST OF ATTENDEES MARCH 20, 2014, MEETING WITH SHINE MEDICAL TECHNOLOGIES, INC.
9:00 A.M - 12:00 P.M.
Name Organization Richard Vann Bynum SHINE Medical Technologies, Inc.
Jim Costedio SHINE Medical Technologies, Inc.
Eric Van Abel SHINE Medical Technologies, Inc.
Bill Hennessy SHINE Medical Technologies, Inc.
Katrina Pitas SHINE Medical Technologies, Inc.
Devon Engleman SHINE Medical Technologies, Inc.
Steve Lynch U.S. Nuclear Regulatory Commission Linh Tran U.S. Nuclear Regulatory Commission Alexander Adams U.S. Nuclear Regulatory Commission Mary Adams U.S. Nuclear Regulatory Commission Kimberly Gambone U.S. Nuclear Regulatory Commission Maria Guardiola U.S. Nuclear Regulatory Commission Greg Chapman U.S. Nuclear Regulatory Commission Patrick Isaac U.S. Nuclear Regulatory Commission Mitzi Young U.S. Nuclear Regulatory Commission Christopher Tripp U.S. Nuclear Regulatory Commission Soly Soto U.S. Nuclear Regulatory Commission Donna-Beth Howe U.S. Nuclear Regulatory Commission Jason Lising U.S. Nuclear Regulatory Commission Larry Harris U.S. Nuclear Regulatory Commission Robert Hoffman U.S. Nuclear Regulatory Commission Kevin Morrissey U.S. Nuclear Regulatory Commission Patricia Silva U.S. Nuclear Regulatory Commission Jeremy Munson U.S. Nuclear Regulatory Commission Matthew Panicker U.S. Nuclear Regulatory Commission Thomas Essig Chesapeake Nuclear Greg Hofer Information Systems Labs Inc.
Terry Gitnick Information Systems Labs Inc.
Ray Vollert Information Systems Labs Inc.
Stephen Marschke Information Systems Labs Inc.
John Atchison Information Systems Labs Inc.
William Newmyer Nuclear Associates LIST OF ATTENDEES MARCH 20, 2014, MEETING WITH SHINE MEDICAL TECHNOLOGIES, INC.
1:00 P.M - 4:00 P.M.
Name Organization Vann Bynum SHINE Medical Technologies, Inc.
Jim Costedio SHINE Medical Technologies, Inc.
Eric Van Abel SHINE Medical Technologies, Inc.
Bill Hennessy SHINE Medical Technologies, Inc.
Katrina Pitas SHINE Medical Technologies, Inc.
Devon Engleman SHINE Medical Technologies, Inc.
Steve Lynch U.S. Nuclear Regulatory Commission Linh Tran U.S. Nuclear Regulatory Commission Alexander Adams U.S. Nuclear Regulatory Commission Patrick Isaac U.S. Nuclear Regulatory Commission Ray Skarda U.S. Nuclear Regulatory Commission Mark Blumberg U.S. Nuclear Regulatory Commission Joseph Staudenmeier U.S. Nuclear Regulatory Commission Mitzi Young U.S. Nuclear Regulatory Commission Thomas Boyle U.S. Nuclear Regulatory Commission Jason Lising U.S. Nuclear Regulatory Commission Robert Hoffman U.S. Nuclear Regulatory Commission Mirela Gavrilas U.S. Nuclear Regulatory Commission Donna-Beth Howe U.S. Nuclear Regulatory Commission Tarek Zaki U.S. Nuclear Regulatory Commission Thomas Essig Chesapeake Nuclear Stephen Alexander Information Systems Labs Inc.
Terry Gitnick Information Systems Labs Inc.
John Atchison Information Systems Labs Inc.
Greg Hofer Information Systems Labs Inc.
William Newmyer Nuclear Associates Discussion Topics for SHINE Meeting Thursday, March 20, 2014 Radioisotope Production Facility
- Identification of each potential accident sequence, including the consequence; likelihood of occurrence; and mitigation or prevention of each potential accident sequence.
- Aspects of the quality assurance and procurement programs and measures assuring long term reliability and availability of engineered controls
- Identification and justification of subcritical margin used for nuclear criticality safety evaluations, accident analyses, and development of safety controls
- Applicability of heterogeneous effects
- Configuration management program, including details on the configuration control process and procedures; and assurance that changes to NCS basis are incorporated into safety-basis documentation.
- Potential for planned exceptions to the double contingency principle
- Controlled parameters (e.g., moderator, concentration, mass, density, enrichment, reflection, interaction, volume, etc.)
- Accident sequences resulting in high or intermediate consequences
- Quality assurance measures applied to design, procurement, construction, operation, maintenance, inspection, testing, and modification of items relied on for safety
- Identification and reliability of passive and active engineered items relied on for safety
- Adequate segregation and isolation between chemicals stored onsite, including the identification of incompatible chemicals and their storage and use locations Enclosure 2
Discussion Topics for SHINE Meeting Thursday, March 20, 2014 Irradiation Facility
- The extent and effect of potential nonuniformities of power, void, temperature, or chemical species within the target solution vessel (TSV) that may limit operating conditions
- Pressure excursions within the TSV
- The uncertainty in the radiolysis rate and the impact this uncertainty may have on sizing of systems in the irradiation units
- Reactivity insertions by the cooling system
- Validation of radiolytic gas formation calculations
- Uncertainty associated with estimated keff values in the irradiation units
- Types of chemicals and radioactive or contaminated materials contained within fire areas
- Facility design modifications based on as low as reasonably achievable (ALARA) considerations