ML23006A185
| ML23006A185 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 09/19/2022 |
| From: | Michael Balazik NRC/NRR/DANU |
| To: | Bartelme J SHINE Medical Technologies |
| References | |
| L-2019-NEW-0004 | |
| Download: ML23006A185 (7) | |
Text
From: Michael Balazik Sent: Monday, September 19, 2022 8:08 AM To: Jeffrey Bartelme Cc: Holly Cruz; Josh Borromeo
Subject:
SHINE RCIs on Phased Startup Operations Attachments: SHINE MEDICAL TECHNOLOGIES, LLC - REQUEST FOR CONFIRMATORY INFORMATION RELATED TO PHASED STARTUP OPERATIONS (EPID NO. L-2019-NEW-0004).pdf Dr. Gregory Piefer Chief Executive Officer SHINE Technologies, LLC 3400 Innovation Court Janesville, WI 53546
SUBJECT:
SHINE MEDICAL TECHNOLOGIES, LLC - REQUEST FOR CONFIRMATORY INFORMATION RELATED TO PHASED STARTUP OPERATIONS (EPID NO. L-2019-NEW-0004)
Dear Dr. Piefer:
By letter dated July 17, 2019 (Agencywide Documents Access and Management System Accession No. ML19211C044), as supplemented, SHINE Medical Technologies, LLC (SHINE) submitted to the U.S. Nuclear Regulatory Commission (NRC) an operating license application for its proposed SHINE Medical Isotope Production Facility in accordance with the requirements contained in Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities. By letter date January 27, 2022 (ML22027A353), SHINE submitted a supplement to the operating license application describing the impacts of phased startup operations. The phased startup operations application supplement describes new or different information from the full facility system descriptions and analyses provided in the final safety analysis report (FSAR) resulting from the SHINE phased approach to initial facility startup and operations.
During the NRC staffs review of SHINEs operating license application, as supplemented, questions have arisen for which confirmatory information is needed. The enclosed request for confirmatory information (RCI) identifies information needed for the NRC staff to continue its review of the SHINE FSAR, submitted in connection with the operating license application, and prepare a safety evaluation report. The specific technical areas of the SHINE operating license application covered by this RCI is Chapter 9, Auxiliary Systems and Chapter 13b, Radioisotope Production Facility Accident Analysis.
It is requested that SHINE provide responses to the enclosed RCI within 30 days from the date of this letter. To facilitate a timely and complete response to the enclosed RCI, the NRC staff is available to meet with SHINE to clarify the scope of information and level of detail expected to be included in the RCI response. SHINE may coordinate the scheduling and agendas for any such meetings with the responsible project manager assigned to this project.
In accordance with 10 CFR 50.30(b), Oath or affirmation, SHINE must execute its response in a signed original document under oath or affirmation. The response must be submitted in accordance with 10 CFR 50.4, Written communications. Information included in the response that is considered sensitive or proprietary, that SHINE seeks to have withheld from the public, must be marked in accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding. Any information related to safeguards should be submitted in accordance with 10 CFR 73.21, Protection of Safeguards Information: Performance Requirements.
Following receipt of the confirmatory information, the NRC staff will continue its evaluation of the subject chapters and technical areas of the SHINE operating license application.
As the NRC staff continues its review of SHINEs operating license application, additional RCIs for other chapters and technical areas may be developed. The NRC staff will transmit any further questions to SHINE under separate correspondence.
If SHINE has any questions, or needs additional time to respond to this request, please contact me at 301-415-2856, or by email to Michael.Balazik@nrc.gov.
Sincerely, Michael Balazik Michael Balazik, 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 Docket No. 50-608 Construction Permit No. CPMIF-001
Enclosure:
As stated
Hearing Identifier: NRR_DRMA Email Number: 1892 Mail Envelope Properties (PH0PR09MB879546AB189EE9CB2F8105DBEA4D9)
Subject:
SHINE RCIs on Phased Startup Operations Sent Date: 9/19/2022 8:07:43 AM Received Date: 9/19/2022 8:07:00 AM From: Michael Balazik Created By: Michael.Balazik@nrc.gov Recipients:
"Holly Cruz" <Holly.Cruz@nrc.gov>
Tracking Status: None "Josh Borromeo" <Joshua.Borromeo@nrc.gov>
Tracking Status: None "Jeffrey Bartelme" <jeffbartelme@shinefusion.com>
Tracking Status: None Post Office: PH0PR09MB8795.namprd09.prod.outlook.com Files Size Date & Time MESSAGE 3925 9/19/2022 8:07:00 AM SHINE MEDICAL TECHNOLOGIES, LLC - REQUEST FOR CONFIRMATORY INFORMATION RELATED TO PHASED STARTUP OPERATIONS (EPID NO. L-2019-NEW-0004).pdf 155854 Options Priority: Normal Return Notification: No Reply Requested: No Sensitivity: Normal Expiration Date:
OFFICE OF NUCLEAR REACTOR REGULATION REQUEST FOR CONFIRMATORY INFORMATION REGARDING OPERATING LICENSE APPLICATION FOR SHINE MEDICAL TECHNOLOGIES, LLC CONSTRUCTION PERMIT NO. CPMIF-001 SHINE MEDICAL ISOTOPE PRODUCTION FACILITY DOCKET NO. 50-608 By letter dated July 17, 2019 (Agencywide Documents Access and Management System Accession No. ML19211C044), as supplemented, SHINE Medical Technologies, LLC (SHINE) submitted to the U.S. Nuclear Regulatory Commission (NRC) an operating license application for its proposed SHINE Medical Isotope Production Facility in accordance with the requirements contained in Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities. By letter date January 27, 2022 (ML22027A353), SHINE submitted a supplement to the operating license application describing the impacts of phased startup operations. The phased startup operations application supplement describes new or different information from the full facility system descriptions and analyses provided in the final safety analysis report (FSAR) resulting from the SHINE phased approach to initial facility startup and operations.
During the NRC staffs review of the SHINE operating license application, and the review of the supplement for phased startup operations, questions have arisen for which confirmatory information is needed. This request for confirmatory information (RCI) identifies information needed for the NRC staff to continue its review of the SHINE FSAR, submitted as part of the operating license application, and prepare a safety evaluation report. Specific chapters and technical areas of the SHINE operating license application covered by this RCI include the following:
- Chapter 9, Auxiliary Systems
- Chapter 13b, Radioisotope Production facility Accident Analysis Applications for the Licensing of Non-Power Reactors: Format and Content, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors, dated October 17, 2012 (ADAMS Accession No. ML12156A069), and Final Interim Staff Guidance Augmenting NUREG-1537, Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: Standard Review Plan and Acceptance Criteria, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors, dated October 17, 2012 (ADAMS Accession No. ML12156A075). As applicable, additional guidance cited in SHINEs FSAR or referenced in NUREG-1537, Parts 1 and 2, or the ISG Augmenting NUREG-1537, Parts 1 and 2, has been utilized in the review of the SHINE operating license application.
Furthermore, the staff have, where appropriate, also referenced NUREG-1520, Standard Review Plan for Fuel Cycle Facilities License Applications, Revision 2, issued June 2015 Enclosure
(ADAMS Accession No. ML15176A258) as guidance.
Chapter 9, Auxiliary Systems" Applicable Regulatory Requirements and Guidance Documents Paragraph (b) of 10 CFR 50.34, Contents of applications: technical information, states, in part, that the final safety analysis report shall include information that describes the facility, presents the design bases and the limits on its operation, and presents a safety analysis of the structures, systems, and components and of the facility as a whole.
RCI 9-1 By letter dated, May 23, 2022 (ML22094A114), the NRC staff issued audit questions to SHINE related to phased startup and operations approach. The NRC staff was seeking to better understand SHINEs approach to safe load handling of heavy loads during phased startup operations. During a review of information made available during the audit, SHINE provided information in response to the NRC staff audit questions 8.a and 8.b.
Confirm that SHINE will implement the guidance in NUREG-0612, Control of Heavy Loads at Nuclear Power Plants, and safety features defined in FSAR Section 9b.7.2 Material Handling System, prior to lifting any heavy loads in the IF or RPF after the start of Phase 1 operations through the end of Phase 4 operations.
Chapter 13b, Radioisotope Production facility Accident Analysis Applicable Regulatory Requirements and Guidance Documents Subparagraph (a)(3) of 10 CFR Part 50.57, Issuance of operating license, states that an operating license may be issued upon finding that, There is reasonable assurance (i) that the activities authorized by the operating license can be conducted without endangering the health and safety of the publicThe NRC staff is reviewing the SHINE operating license application, using the applicable regulations, as well as the guidance contained in NUREG-1537 and its associated ISG. Interim Staff Guidance Augmenting NUREG-1537, Part 2 provides additional guidance regarding the use of NUREG-1537.
SHINE FSAR section 13b.1.2, Accident Initiating Events, describes that preventative or mitigative controls are identified to reduce the overall risk of the evaluated accident scenarios to within acceptable limits.
Interim Staff Guidance Augmenting NUREG-1537, Part 2, section 13b.1, Radioisotope Production Facility Accident Analysis Methodology, states, in part, that an application may be found acceptable if the applicant demonstrates that the proposed equipment and facilities to prevent or mitigate accidents are adequate to protect health and minimize danger to life or property, and that proposed procedures to prevent or mitigate accidents are adequate to protect health and minimize danger to life or property. The acceptance criteria within this section includes, in part, the following:
- For a radioisotope production facility, one means by which the results of the accident analysis may demonstrate adequate safety is by proposing and justifying alternate performance criteria that the NRC staff determines to demonstrate adequate safety; and 2
- NUREG-1520, Section 3.4, provides additional criteria for adherence to the safety program and ISA performance.
NUREG-1520 section 3.4.3.1, Safety Program and Integrated Safety Analysis Commitments, states, in part, that human factors practices should be incorporated into the safety program sufficiently to ensure that management measures perform their functions. The general methodology presented within NUREG-1520 Chapter 3, Appendix E, Human Factors Engineering for Personnel Activities, is an appropriate approach for supporting the reliability of administrative controls.
NUREG-1520 Chapter 3, Appendix E includes, in part, the following:
Section H - Training Program Development The applicants training program development should address all personnel activities. The training program development indicates how the knowledge and skill requirements of personnel will be evaluated, how the training program development will be coordinated with the other activities of the HFE design process, and how the training program will be implemented in an effective manner consistent with human factors principles and practices.
The training program development should address the areas of review and acceptance criteria described in Chapter 11 of this SRP and should result in a training program that provides personnel with qualifications commensurate with their activities.
The SHINE phased startup operations application supplement describes in section 13b.1.2 that phased startup operations result in certain accident sequences within the Radioisotope Production Facility (RPF) being modified based upon increased likelihood. One such accident sequence is listed as being Heavy load drop onto the radioactive liquid waste immobilization (RWLI) shielded enclosure or supercell. Furthermore, it is also stated that One new credited specific administrative control is required to prevent phased startup operation accident sequences in the RPF.
In order to better understand the modified accident sequence and credited specific administrative control described above, the staff reviewed TECRPT-2020-0016, SHINE Safety Analysis Summary Report, Revision 5, Section 4.1.2, and the preventative controls for event 13b.2.7-A. Appendix E of that report indicates that one of the reliability management measures for the associated preventative controls includes training.
In reviewing the submitted FSAR, RAI responses, and phased startup operations application supplement, the staff did not locate information related to the training of crane operators on specific administrative controls. This is a concern within the context of phased startup operations because a training of such individuals appears to be being credited to support the reliability of a specific administrative control that, in turn, is being credited to address an accident sequence affected by phased startup operations.
RCI HFE-1 By letter dated, August 23, 2022 (ML22061A212), the NRC staff issued audit questions to SHINE related to phased startup and operations approach. During an audit discussion on August 25, 2022, SHINE indicated that crane operators 3
will consist of either operations or maintenance personnel and, furthermore, that their training and qualification process will include coverage of both the specific administrative controls and procedures that are associated with crane-related lifting and rigging operations.
Confirm the accuracy of this information regarding the training of crane operators.
4