ML21089A334

Shine Medical Technologies, LLC - Summary of Audit Related to Geotechnical Topics

ML21089A334
Person / Time
Site:	SHINE Medical Technologies
Issue date:	04/07/2021
From:	Steven Lynch NRC/NRR/DANU/UNPL
To:	Piefer G SHINE Medical Technologies
Lynch S
References
EPID L-2019-NEW-0004
Download: ML21089A334 (8)

Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 7, 2021 Dr. Gregory Piefer, Chief Executive Officer SHINE Medical Technologies, LLC 101 East Milwaukee Street, Suite 600 Janesville, WI 53545

SUBJECT:

SHINE MEDICAL TECHNOLOGIES, LLC -

SUMMARY

OF AUDIT RELATED TO GEOTECHNICAL TOPICS (EPID NO. L-2019-NEW-0004)

Dear Dr. Piefer:

By letter dated July 17, 2019 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML19211C044), as supplemented by letters dated November 14, 2019 (ADAMS Accession No. ML19337A275), March 27, 2020 (ADAMS Accession No. ML20105A295), August 28, 2020 (ADAMS Accession No. ML20255A027),

November 13, 2020 (ADAMS Accession No. ML20325A026), December 10, 2020 (ADAMS Accession No. ML20357A084), and December 15, 2020 (ADAMS Accession No. ML21011A264), 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 Part 50, Domestic Licensing of Production and Utilization Facilities.

To enhance the review of geotechnical topics associated with the SHINE operating license application the NRC staff conducted a regulatory audit on March 16, 2021. A summary of the regulatory audit is enclosed.

G. Piefer If SHINE has any questions please contact me at 301-415-1524, or by electronic mail at Steven.Lynch@nrc.gov.

Sincerely, Steven T. Lynch Steven T. Lynch, Senior 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 cc: See next page

SHINE Medical Technologies, LLC Docket No. 50-608 cc:

Jeff Bartelme Licensing Manager SHINE Medical Technologies, LLC 101 East Milwaukee Street, Suite 600 Janesville, WI 53545 Nathan Schleifer General Counsel SHINE Medical Technologies, LLC 101 East Milwaukee Street, Suite 600 Janesville, WI 53545 Christopher Landers Director, Office of Conversion National Nuclear Security Administration, NA 23 U.S. Department of Energy 1000 Independence Avenue, SW Washington, DC 20585 Mark Paulson Supervisor Radiation Protection Section Wisconsin Department of Health Services P.O. Box 2659 Madison, WI 53701-2659 Test, Research and Training Reactor Newsletter Attention: Amber Johnson Dept. of Materials Science and Engineering University of Maryland 4418 Stadium Drive College Park, MD 20742-2115 Mark Freitag City Manager P.O. Box 5005 Janesville, WI 53547-5005 Bill McCoy 1326 Putnam Avenue Janesville, WI 53546 Alfred Lembrich 541 Miller Avenue Janesville, WI 53548

ML21089A334 NRR-106 OFFICE NRR/DANU/PM NRR/DANU/LA NRR/DEX/BC NRR/DANU/BC (A) NRR/DANU/PM NAME SLynch NParker JColaccino DHardesty SLynch DATE 4/2/2021 4/5/2021 4/5/2021 4/7/2021 4/7/2021 OFFICE OF NUCLEAR REACTOR REGULATION REGULATORY AUDIT

SUMMARY

REGARDING GEOTECHNICAL TOPICS DESCRIBED IN OPERATING LICENSE APPLICATION SHINE MEDICAL TECHNOLOGIES, LLC CONSTRUCTION PERMIT NO. CPMIF-001 SHINE MEDICAL ISOTOPE PRODUCTION FACILITY DOCKET NO. 50-608 Location: SHINE Medical Technologies, LLC, Janesville, Wisconsin Audit Date: March 16, 2021 Audit Team Members: Steven Lynch, Senior Project Manager Zuhan Xi, Geotechnical Engineer Amitava Ghosh, Geotechnical Engineer Joseph Colaccino, Chief, Structural, Civil, and Geotechnical Engineering Branch Licensee Representatives: Jeff Bartelme, SHINE Director of Licensing Jim Costedio, SHINE Vice President of Regulatory Affairs and Quality Abbey Donahue, SHINE Structural Engineering Manager Marc Anderson, Sargent & Lundy Joshua Bickett, Sargent & Lundy Jonathan Dean, Sargent & Lundy David Nielson, Sargent & Lundy

1.0 BACKGROUND

By letter dated July 17, 2019 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML19211C044), as supplemented by letters dated November 14, 2019 (ADAMS Accession No. ML19337A275), March 27, 2020 (ADAMS Accession No. ML20105A295), August 28, 2020 (ADAMS Accession No. ML20255A027),

November 13, 2020 (ADAMS Accession No. ML20325A026), December 10, 2020 Enclosure

(ADAMS Accession No. ML20357A084), and December 15, 2020 (ADAMS Accession No. ML21011A264), 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. This regulatory audit was intended to assist the NRC staff in its review of the geotechnical topics described in the SHINE final safety analysis report (FSAR), submitted as part of SHINEs operating license application.

This audit supported the NRC staffs review of the licensees geotechnical topics program using the applicable 10 CFR requirements, as well as the guidance contained in NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Format and Content, issued February 1996 (ADAMS Accession No. ML042430055),

and NUREG-1537, Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Standard Review Plan and Acceptance Criteria, issued February 1996 (ADAMS Accession No. ML042430048). The NRC staff is also using the Final 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, 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.

The audit was conducted in accordance with the audit plan and associated topics (ADAMS Package No. ML21053A259).

2.0 AUDIT ACTIVITIES AND OBSERVATIONS Entrance Briefing The NRC staff discussed the goals and objectives of the audit at the entrance briefing, which focused on gaining a better understanding of SHINE geotechnical topics. In addition, it was discussed that the regulatory audit may identify additional information that would be required to be docketed to support the basis of the licensing decision and allow NRC staff to more efficiently gain insights on the operating license application. Further, the NRC staff indicated that the information gained from the audit review would assist the NRC staff to better focus any requests for additional information (RAIs) needed to support the review.

Review of Audit Information SHINE made the documents listed in Table 1, Audit Review Documents, available on its electronic reading room for NRC staff to review in preparation for the regulatory audit discussions. The documents included the evaluation of ultimate bearing capacity and allowable soil bearing capacity, as well as a calculation package for the structural design of the SHINE facility, including a detailed total settlement analysis and the predicted subgrade modulus of the site soils for the structural analysis.

Table 1, Audit Review Documents Document No. Title Revision Date Golder Report #8 of Geotechnical Calculations, Bearing 1 08/03/2012 Project No. 113-81051 Capacity, and Settlement Sargent & Lundy Report SHINE Facility Structural Design 8 01/27/2021 CALC-2017-1000 Summary of Observations The NRC staff reviewed the documents listed in Table 1 to verify information provided in SHINEs response to RAI 3.4-6, provided by letter dated December 15, 2020 (ADAMS Accession No. ML21011A264). Specifically, the NRC staff sought to confirm that the allowable soil bearing pressure is higher than the foundation contact pressures and that differential and total settlements are not beyond maximum allowable values. The NRC staff focused its audit review on the Golder Report #8, as well as Attachment P, Evaluation of Soil Subgrade Modulus, and Attachment X, DL and LL Diagram for Geotechnical Calculations, of Sargent &

Lundy Report CALC-2017-1000.

The NRC staff examined the analyses and calculations in the reference documents and confirmed that that the soil properties used for the analysis are proper and conservative. For SHINEs bearing capacity evaluation, the NRC staff noted that the calculation method is widely accepted and used by the industry. The NRC staff acknowledged that the assumption of a small foundation size in the calculation leads to a conservative estimate of the bearing capacity.

For SHINEs settlement calculation, the NRC staff noted that the total settlement was evaluated by three different recognized methods.

The NRC staff conducted a regulatory audit teleconference on March 16, 2021, with SHINE to better understand how the analyses and calculations provided in the electronic reading room support the information provided by SHINE in its response to RAI 3.4-6. The following topics were discussed during the teleconference:

allowable soil bearing capacities, including the predicted maximum foundation contact pressure from structural response analyses; allowable settlement limits; settlement profile in consideration of loading variation over the mat foundation, rigidity of mat foundation, and subgrade soil material; and soil depth of influence used in settlement analysis.

Based on the review of the information provided to the NRC staff to review via the internet portal and the discussion at the audit teleconference on March 16, 2021, the NRC staff found that SHINE provided an evaluation of ultimate and allowable bearing capacities that is conservative and acceptable to support information provided in the FSAR and agreed upon revisions to the FSAR and RAI response.

Exit Briefing On March 16, 2021, the NRC staff held an exit meeting with the licensee. No issues or concerns were identified by the licensee during the audit exit briefing. The NRC staff indicated the audit was concluded.

3.0 RESULTS OF REGULATORY AUDIT During the regulatory audit, SHINE provided clarification and/or justification of the information provided in its response to RAI 3.4-6 and additional detail related to the NRC staff discussion topics. As a result of these discussions, SHINE agreed to revise its application materials as follows:

1) Clarify the net allowable static bearing pressure in FSAR Section 3.4.2.6.3.1, Soil Parameters, provide information on the predicted maximum foundation contact pressure from the structural response analyses under design loading conditions, and verify the maximum pressure that can be enveloped by the allowable soil bearing capacity.

2) Supplement the response to RAI 3.4-6 to include the information that the facility structure is designed to accommodate the potential differential and total settlements of the foundation of the facility structure and, consequently, that there are no allowable settlement limits.

Since SHINE agreed to voluntarily supplement the FSAR and the response to RAI 3.4-6, the NRC staff did not identify any outstanding issues following the conclusion of this regulatory audit.