ML25115A140
| ML25115A140 | |
| Person / Time | |
|---|---|
| Site: | 99902077 |
| Issue date: | 05/15/2025 |
| From: | Miller A NRC/NRR/DANU/UNPL |
| To: | Wagner C Eden Radioisotopes |
| References | |
| EPID L-2025-LRM-0009 | |
| Download: ML25115A140 (7) | |
Text
Mr. Chris Wagner, Chief Executive Officer Eden Radioisotopes, LLC 9400 Holly Ave. NE, Suite 202 Albuquerque, NM 87122
SUBJECT:
EDEN RADIOISOTOPES, LLC - PRE-APPLICATION READINESS ASSESSMENT OBSERVATIONS ON EDEN DRAFT PRELIMINARY SAFETY ANALYSIS REPORT FOR A MEDICAL ISOTOPE PRODUCTION FACILITY (EPID L-2025-LRM-0009)
Dear Mr. Wagner:
On February 25 - March 27, 2025, the U.S. Nuclear Regulatory Commission (NRC) staff conducted a pre-application readiness assessment (hereinafter readiness assessment) of the draft preliminary safety analysis report (PSAR) which Eden has prepared in support of its construction permit application for a medical isotope production facility.
The readiness assessment is not part of the NRCs official acceptance review process. The staff performed the readiness assessment of Edens draft PSAR to understand the level of detail of the draft PSAR and identify any major issues or information gaps between the draft PSAR and the technical content required to be included in the application submitted to the NRC. Therefore, the observations from the readiness assessment do not predetermine whether the application will be docketed.
The enclosed document provides the NRC staff observations on Edens draft PSAR. Please consider these observations when finalizing your PSAR.
May 15, 2025
C. Wagner If you have any questions or comments about this matter, please contact Linh Tran at (301) 415-4103, or via email at Linh.Tran@nrc.gov or Andrew Miller at (301) 415-1080, or via email at Andrew.Miller@nrc.gov.
Sincerely, Andrew J. Miller, Project Manager Non-Power Production and Utilization Facility Licensing Branch Division of Advanced Reactors and Non-Power Production and Utilization Facilities Office of Nuclear Reactor Regulation Project No. 99902077
Enclosure:
Summary report on the pre-application audit of Eden Radioisotopes, LLC draft PSAR cc w/enclosure: GovDelivery Subscribers Signed by Miller, Andrew on 05/15/25
ML25115A140 NRC-106 OFFICE NRR/DANU/UNPL/PM NRR/DANU/UNPL/LA NRR/DANU/UNPL/TL NAME AMiller NParker MBalazik DATE 4/30/2025 5/5/2025 5/7/2025 OFFICE NRR/DANU/UNPL/ABC NRR/DANU/UNPL/PM NAME EHelvenston AMiller DATE 5/13/2025 5/15/2025
Enclosure
SUMMARY
REPORT ON THE PRE-APPLICATION AUDIT OF EDEN RADIOISOTOPES, LLC DRAFT PRELIMINARY SAFETY ANALYSIS REPORT February 25 - March 27, 2025
1.0 BACKGROUND
On February 25, 2025, through March 27, 2025, the U.S. Nuclear Regulatory Commission (NRC) staff conducted a pre-application readiness assessment (hereinafter readiness assessment) of the draft preliminary safety analysis report (PSAR) prepared by Eden Radioisotopes, LLC (Eden) in support of its anticipated construction permit (CP) application for the Eden Isotope Production Complex. The NRC staff conducted the readiness assessment in accordance with the audit plan provided to Eden on February 11, 2025 (Agencywide Documents Access and Management System Accession No. ML25045A016), and as requested by Eden in its letter dated January 17, 2025 (ML25017A058).
2.0 AUDIT REGULATORY BASES The bases for the audit are the regulations at paragraph (a) of Title 10 of the Code of Federal Regulations (10 CFR) Section 50.34, Contents of applications; technical information, 10 CFR Section 50.35, Issuance of construction permits, 10 CFR Section 50.40, Common standards, and 10 CFR Section 50.50, Issuance of licenses and construction permits. The NRC staff also conducted the audit using the guidance in Interim Staff Guidance [ISG] Augmenting NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: Format and Content, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors (ML12156A069).
3.0 AUDIT PURPOSE AND OBJECTIVES The purpose of this audit was to provide the NRC staff with an opportunity to assess the readiness of the draft PSAR before Eden formally submitted the CP application. This audit allowed the NRC staff to (1) identify any required information that is missing from the application, (2) identify technical or regulatory issues that may complicate the acceptance or technical reviews of the application, and (3) become familiar with the content of the application.
4.0 SCOPE OF THE AUDIT AND AUDIT ACTIVITIES The readiness assessment focused on the following chapters of Edens draft PSAR:
Draft PSAR chapter 1, The Facility Draft PSAR chapter 2, Site Characteristics Draft PSAR chapter 3, Design of Structures, Systems and Component Draft PSAR chapter 4a, Reactor Description Draft PSAR chapter 4b, Radioisotope Production Facility Description Draft PSAR chapter 5a, Reactor Coolant System Draft PSAR chapter 5b, Radioisotope Production Facility Coolant System Draft PSAR chapter 6a, Reactor Engineered Safety Features Draft PSAR chapter 6b, Radioisotope Production Facility Engineered Safety Features Draft PSAR chapter 7a, Reactor I&C [Instrumentation and Control] Systems Draft PSAR chapter 7b, Radioisotope Production Facility I&C Systems Draft PSAR chapter 8, Reactor and Radioisotope Production Facility Electrical Power Systems Draft PSAR chapter 9, Reactor and Radioisotope Production Facility Auxiliary Systems Draft PSAR chapter 10, Experimental Facilities and Utilization Draft PSAR chapter 11, Radiation Protection Program & Waste Management Draft PSAR chapter 12, Conduct of Operations Draft PSAR chapter 13a, Reactor Accident Analysis Draft PSAR chapter 13b, Radioisotope Production Facility Accident Analysis Draft PSAR chapter 14, Technical Specification Draft PSAR chapter 15, Financial Qualifications The readiness assessment was conducted virtually using Edens Electronic Reference Portal and communications via teleconference/video conference.
NRC staff audit team members included:
Edward Helvenston Acting Branch Chief, Licensing Linh Tran Senior Project Manager (responsible for audit logistics)
Michael Balazik Project Manager, Audit Lead (responsible for technical review)
Duane Hardesty Senior Project Manager Brooke Gallagher Project Manager Carol Dye Geologist Jason White Physical Scientist (Meteorologist)
Hosung Ahn Hydrologist Jenise Thompson Geologist Sarah Tabatabai Geophysicist Luissette Candelario-Quintana Civil Engineer Se-Kwon Jung Senior Civil Engineer Nick Hansing Mechanical Engineer Santosh Bhatt Senior Nuclear Engineer Brandon Wise Reactor System Engineer Jo Ambrosini Nuclear Engineer Hanry Wagage Senior Safety and Plant Systems Engineer Brian Lee Senior Safety and Plant Systems Engineer Brian Wagner Reliability and Risk Analyst Sheila Ray Senior Electrical Engineer Edward Stutzcage Reactor Scientist (Radiation)
Glenn Tuttle Material Control and Accounting Physical Inspection Analyst Edward Robinson Senior Emergency Preparedness Specialist Langston Lewis Reliability and Risk Analyst James Hammelman Senior Chemical Process Engineer Shawn Harwell Financial Analyst Frankie Vega Reactor Ops Engineer (Quality Assurance)
Norbert Carte Senior Electronics Engineer Andrew Miller Project Manager Amitava Ghosh Physical Scientist (Hazards Analyst)
Charles Moulton Fire Protection Engineer Logan Crevelt Nuclear Process Engineer Catie Szumski Nuclear Engineer, Nuclear Systems Performance (Training only)
Zee St. Hilaire Nuclear Process Engineer (Training only)
Nicole Cortes Chemical Safety Scientist (Training only)
Jennifer Beaton General Engineer (Training only)
The NRC staff did not acquire any documents during the audit.
5.0
SUMMARY
OF OBSERVATIONS The NRC staffs summary of observations listed below is based on the notes taken during the audit. The main purpose of the audit was to identify issues which could challenge potential acceptance of the PSAR when submitted and potential challenging regulatory or technical issues which may need additional documentation. In particular, the NRC staff noted:
Observations on potential acceptance review issues:
Related to draft PSAR chapter 2, the NRC staff noted that details on the site characteristics, such as seismic hazard analysis inputs and results, design response spectrum, site response analysis inputs, and methodology, would be necessary for the NRC staff to evaluate the sufficiency of the facility design. The NRC staffs observation was based on 10 CFR 50.34(a)(1)(i), which states, in part, that the PSAR must include A description and safety assessment of the site on which the facility is to be located, with appropriate attention to features affecting facility design. The NRC staff informed Eden of this concern during a teleconference on April 10, 2025.
Related to draft PSAR chapter 2, the NRC staff noted that further details on the site characteristics, such as site-specific geotechnical information to demonstrate the stability of subsurface material and the stability of slopes, and an adequate basis on the application of nearby site data to Edens specific site, would be necessary for the NRC staff to evaluate the stability of the facility structures. The NRC staffs observation was based on 10 CFR 50.34(a)(1)(i), which states, in part, that the PSAR must include A description and safety assessment of the site on which the facility is to be located, with appropriate attention to features affecting facility design, and 10 CFR 50.34(a)(4), which states, in part, that the PSAR must include A preliminary analysis of evaluation of the design and performance of structures, systems, and components of the facility with the objective of assessing the risk to public health and safety resulting from operation of the facility, and the adequacy of structures, systems, and components provided for the prevention of accidents and the mitigation of the consequences of accidents. The NRC staff informed Eden of this concern during a teleconference on April 10, 2025.
Related to draft PSAR chapter 13b, the NRC staff noted the need for further details on the integrated safety analysis (ISA) methodology, such as a clear definition of the term credible or an explanation of the deviation from the typically accepted definition of credible as stated in NUREG-1520, Standard Review Plan for Fuel Cycle Facilities License Applications (ML15176A258). These details are necessary to ensure that all credible accident sequences with unacceptable risk are further evaluated to identify potential structures, systems, and components (SSCs), engineered safety features (ESFs), and probable subjects of technical specifications (TSs) needed to prevent the occurrence or mitigate the consequences of accidents, and that all credible initiating events due to failure of SSCs, ESF, and probable subjects of TSs are identified and analyzed. The ISG Augmenting NUREG-1537, Part 1, provides guidance that the ISA methodology described in NUREG-1520 is an acceptable method for demonstrating adequate safety for a medical isotope production facility, e.g., Edens proposed hot cell facility (HCF). If methods used are different than those described in the ISG, the application should provide a safety basis for the NRC staff to determine compliance with regulations. The NRC staffs observation was based on 10 CFR 50.34(a)(4), which states, in part, that the PSAR must include A preliminary analysis of evaluation of the design and performance of structures, systems, and components of the facility with the objective of assessing the risk to public health and safety resulting from operation of the facility, and the adequacy of structures, systems, and components provided for the prevention of accidents and the mitigation of the consequences of accidents. The NRC staff informed Eden of this concern during a teleconference on April 10, 2025.
General observations (the NRC staff does not consider these to be potential acceptance review issues but may seek additional information on specific related items as necessary if a CP application is accepted for review):
There is general inconsistency between the reactor facility (RF) and HCF design criteria (DC) stated in chapter 3 of the draft PSAR and the remaining chapters of the draft PSAR that describe (or sometimes omit) the actual design implementation that corresponds to the specific SSCs. DC should be specified for each SSC that is assumed to perform an operational or safety function. Additionally, the design bases in the PSAR should include references to the applicable standards, guidance, and codes. For example, o
RF DC-3 does not align with draft PSAR section 9a.3.2.2, which states the fire protection system does not perform safety-related functions. Draft PSAR table 3.5-1a categorizes the fire protection system as quality level (QL)-2 (i.e.,
not quality-related) but section 9a.3.1 states that the fire protection program protects SSCs to ensure safe shutdown is not prevented.
o Draft PSAR section 7a.2.1.1 describes the DC applicable to the RF I&C systems using a bulleted list of DC numbers and names, and a summary description of how each DC is addressed in chapter 7. However, the descriptions appear to simply assert that the DC are met rather than providing descriptions of how the DC are met (i.e., providing design basis information).
The NRC staff observed inconsistencies within and between draft PSAR chapters, such as core row designations in chapter 4, identification of limiting safety systems settings between chapter 7 and chapter 14, and I&C functions between chapter 5 and chapter 7.
The NRC staff noted that there appears to be a lack of conservatism in the subcritical mass limit for the HCF in draft PSAR chapter 6b.
The NRC staff noted certain values and content using the annotation [TBD] in draft PSAR chapter 7. This nomenclature was not used in any other chapters of the draft PSAR and it was not clear to the NRC staff if these annotations were intended to denote information that would be provided in the final PSAR, information that would be provided in an operating license application, or something else.
The NRC staff noted that the analysis performed in draft PSAR chapter 4 did not include or bound changes within the core over time. These effects include fuel burnup, mixed target batches, and boron depletion.
The draft PSAR makes many references to similarities to equipment at facilities of similar design for which applications have previously been filed with the Commission.
The draft PSAR states that equipment is used in other research reactors without sufficient detail to make any inference as to its suitability for use in the Eden I&C systems.
Where I&C functions are credited in the safety analysis, an NRC reviewer must verify that all functions credited in the analysis are implemented in the I&C equipment design.
An explicit cross reference of I&C function(s) to the analyses of associated limiting event(s) may help make the review more efficient.
The PSAR should describe the systems and features designed to protect the RF and HCF from damage by fire and external hazards and discuss how the facility meets local fire and building codes. For PSAR references to the pertinent industry standards and PSAR citations of conformance to local building codes, it may be helpful to include specific clauses and criteria used for compliance.
The NRC staff noted that analyses of potential pipeline hazards are not provided in draft PSAR chapter 2.
6.0 EXIT DISCUSSION The NRC staff held a summary meeting with Eden on April 10, 2025. At the meeting, the NRC staff reiterated the purpose of the audit and discussed observations on potential acceptance issues and other general observations, as summarized above. At Edens request, the NRC staff and Eden held two additional meetings on April 30 and May 15, 2025, to further discuss the staffs observations.
7.0 REQUESTS FOR ADDITIONAL INFORMATION RESULTING FROM AUDIT The NRC staff did not use the formal request for additional information process as part of this audit. The NRC staff provided Eden questions and feedback during the audit, which Eden could consider and use to revise its PSAR prior to submittal of the CP application.
8.0 OPEN ITEMS AND PROPOSED CLOSURE PATHS Not applicable. There are no open items as a result of this audit.