ML25045A016
| ML25045A016 | |
| Person / Time | |
|---|---|
| Site: | 99902077 |
| Issue date: | 02/11/2025 |
| From: | Linh Tran NRC/NRR/DANU |
| To: | Wagner C Eden Radioisotopes |
| References | |
| L-2025-LRM-0009 | |
| Download: ML25045A016 (6) | |
Text
From:
Linh Tran Sent:
Tuesday, February 11, 2025 1:39 PM To:
Chris Wagner Cc:
Jim Saldarini; Michael Balazik; Brooke Gallagher; Holly Cruz
Subject:
Eden Radioisotopes, LLC - Audit Plan for the Preapplication Readiness Assessment of Draft PSAR Attachments:
Eden Radioisotope - Draft PSAR Readiness Assessment Audit Plan.pdf
Dear Mr. Wagner:
By letter dated January 17, 2025 (Agencywide Documents Access and Management System Accession No. ML25017A058), Eden Radioisotopes, LLC (Eden) requested that the U.S. Nuclear Regulatory Commission (NRC) staff conduct a preapplication readiness assessment (hereinafter readiness assessment) of the draft preliminary safety analysis report (PSAR) which Eden has prepared in support of its construction permit (CP) application for a medical isotope production facility. Eden also provided an estimated of 260 hours0.00301 days <br />0.0722 hours <br />4.298942e-4 weeks <br />9.893e-5 months <br /> for the NRC staff to conduct the readiness assessment.
The NRC staff, through discussions with Edens Licensing Director Jim Saldarini, has determined that February 25, 2025, through March 27, 2025, would be an appropriate start date and duration for conducting the readiness assessment as part of preapplication interactions regarding Edens draft PSAR.
The readiness assessment is not part of the NRCs official acceptance review process. The readiness assessment will allow the NRC staff to understand the level of detail and identify any major issues or information gaps between the draft PSAR and the technical content required to be included in the CP application submitted to the NRC. Therefore, the observations from the readiness assessment do not predetermine whether the application will be docketed.
The attached readiness assessment plan provides the details and logistics of the readiness assessment activities of Edens draft PSAR.
If you have any questions, please contact Linh Tran at (301) 415-4103 or via email at Linh.Tran@nrc.gov, Michael Balazik at (301) 415-2856 or via email at Michael.Balazik@nrc.gov, or Brooke Gallagher at (301) 415-5280 or via email at Brooke.Gallagher@nrc.gov.
Thank you, Linh Tran, U.S. NRC Non-Power Production and Utilization Facility Licensing Branch (UNPL)
Division of Advanced Reactors and Non-Power Production and Utilization Facilities (DANU)
Office of Nuclear Reactor Regulation (NRR) 301-415-4103 Linh.Tran@nrc.gov Docket No. 99902077 EPID: L-2025-LRM-0009
Hearing Identifier:
NRR_DRMA Email Number:
2727 Mail Envelope Properties (BY5PR09MB4931AF4A57E71A0484D21051F1FD2)
Subject:
Eden Radioisotopes, LLC - Audit Plan for the Preapplication Readiness Assessment of Draft PSAR Sent Date:
2/11/2025 1:38:59 PM Received Date:
2/11/2025 1:38:00 PM From:
Linh Tran Created By:
Linh.Tran@nrc.gov Recipients:
"Jim Saldarini" <jsaldarini@edenrad.com>
Tracking Status: None "Michael Balazik" <Michael.Balazik@nrc.gov>
Tracking Status: None "Brooke Gallagher" <Brooke.Gallagher@nrc.gov>
Tracking Status: None "Holly Cruz" <Holly.Cruz@nrc.gov>
Tracking Status: None "Chris Wagner" <cwagner@edenrad.com>
Tracking Status: None Post Office:
BY5PR09MB4931.namprd09.prod.outlook.com Files Size Date & Time MESSAGE 2189 2/11/2025 1:38:00 PM Eden Radioisotope - Draft PSAR Readiness Assessment Audit Plan.pdf 221556 Options Priority:
Normal Return Notification:
No Reply Requested:
No Sensitivity:
Normal Expiration Date:
EDEN RADIOISOTOPES, LLC - AUDIT PLAN FOR THE PREAPPLICATION READINESS ASSESSMENT OF DRAFT PRELIMINARY SAFETY ANALYIS REPORT FOR A MEDICAL ISOTOPE PRODUCTION FACILITY (EPID: L-2025-LRM-0009)
Applicant Information:
Applicant:
Eden Radioisotopes, LLC Applicant Address:
9400 Holly Ave NE, Suite 202 Albuquerque, NM 87122 Facility Name:
Eden Isotope Production Complex Docket No.:
99902077 Audit Location:
The U.S. Nuclear Regulatory Commission (NRC) staff plans to conduct Eden Radioisotopes, LLC (Eden) preapplication readiness assessment (hereinafter readiness assessment) audit virtually using Edens electronic reference portal (ERP) and communicate via teleconference and/or video conference.
Purpose:
By letter dated January 17, 2025 (Agencywide Documents Access and Management System Accession No. ML25017A058), Eden requested that the NRC staff conduct a readiness assessment of the draft preliminary safety analysis report (PSAR) which Eden has prepared in support of its construction permit (CP) application submission.
The readiness assessment will allow the NRC staff to:
Identify information gaps between the draft PSAR and the technical content required in the version of the report submitted to the NRC.
Identify major technical or policy issues that may adversely impact a timely technical review of the application.
The observations from the readiness assessment will inform Eden in finalizing its CP application and will assist the NRC staff in planning NRC resources in preparation for the application review once the application is formally submitted.
Background:
By letter dated August 7, 2023 (ML23230B208), Eden informed the NRC of its intent to submit license applications for a CP and subsequent operating license (OL) for a medical isotope production facility, called the Eden Isotope Production Complex (EIPC), under Title 10 of the Code of Federal Regulations (10 CFR) Part 50, "Domestic Licensing of Production and Utilization Facilities." The design of the Edens EIPC includes a 2-megawatt light-water reactor (all-target reactor) with hot cells and target fabrication facility expected to be located near Eunice, New Mexico.
Scope of the Readiness Assessment:
The readiness assessment will focus on the Edens Draft PSAR as discussed in its January 17, 2025, letter including the following chapters:
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 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 Information and Other Material Necessary for the Readiness Assessment:
Eden will make available its draft PSAR on Edens ERP. The NRC staff will use ERP to perform the readiness assessment. Access to the ERP is limited to specific NRC staff (e.g., based on NRC email addresses or the use of passwords which will only be assigned to NRC staff directly involved in the readiness assessment on a need-to-know basis), and documents in the ERP is read-only. The conditions associated with the ERP must be maintained throughout the review process. The NRC staff who should be granted access to the ERP are those listed in the Readiness Assessment Audit Team section below. The NRC staff will provide a request to close the ERP at the conclusion of the audit.
Readiness Assessment Audit Team:
Holly Cruz 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 Charley Peabody Nuclear 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 Jeremy Munson Nuclear Engineer (Criticality Shield)
Norbert Carte Senior Electronics Engineer Sheila Ray Senior Electrical Engineer Edward Stutzcage Reactor Scientist (Radiation)
Glenn Tuttle Material Control and Accounting Physical Inspection Analyst Amy Beasten Reactor Engineer (RTR Examiner)
Tom Eck Security Specialist (RTR)
Charles Teal Senior Security Risk Analyst Dong Park Reactor Ops Engineer (QA Inspect)
Edward Robinson Senior Emergency Preparedness Specialist Jamole Skeeter Emergency Preparedness Specialist Langston Lewis Reliability and Risk Analyst James Hammelman Senior Chemical Process Engineer Shawn Harwell Financial Analyst Additional audit team members may be added as needed.
Logistics:
The readiness assessment audit will be conducted during the period of February 25, 2025, through March 27, 2025. An entrance meeting is scheduled for Tuesday, February 25, 2025, to kick-off the audit. An exit meeting will be conducted at the conclusion of the audit.
The NRC staff will charge time for this readiness assessment to the following fee-billable cost activity code number: Docket No. 99902077, EPID No. L-2025-LRM-0009.
Special Requests:
All NRC audit team members will observe appropriate handling and protection of proprietary information throughout the readiness assessment. The NRC and Eden Electronic Reference Portal Information Access Agreement (ML24066A198) shall be reviewed by NRC audit team members.
The NRC staff requests that Eden ensure that its technical staff are available to answer questions during the audit.
NRC Review Approach:
The NRC staff will focus on identifying and documenting technical and regulatory gaps in the draft PSAR chapter/section. These gaps, and other observations relevant to application quality and completeness will be compiled into a final readiness assessment report to Eden after all the sections have been examined.
The NRC staff will conduct the readiness assessment that includes the following aspects:
Part 50, Domestic licensing of production and utilization facilities, of 10 CFR.
The content of the PSAR will be informed by the Interim Staff Guidance 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).
NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Format and Content (ML12251A353).
NRC Project Managers will provide regular status updates to NRC management and Eden, as needed.
Readiness Assessment Observations:
The NRC staff will provide the readiness assessment observations, including any identified technical concerns or major information gaps, to Eden in a publicly available audit summary.
The audit summary will be declared and entered as an official agency record in ADAMS and be made available for public viewing, as appropriate. The NRC staffs expectation is that Eden will consider the observations from the readiness assessment while finalizing its CP application.