ML21053A260

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Shine Medical Technologies - Geotechnical Audit Topics
ML21053A260
Person / Time
Site: SHINE Medical Technologies
Issue date: 03/11/2021
From: Steven Lynch
NRC/NRR/DANU/UNPL
To: Piefer G
SHINE Medical Technologies
Shared Package
ML21053A259 List:
References
Download: ML21053A260 (3)


Text

OFFICE OF NUCLEAR REACTOR REGULATION REGULATORY AUDIT TOPICS REGARDING GEOTECHNICAL ENGINEERING TOPICS DESCRIBED IN OPERATING LICENSE APPLICATION CONSTRUCTION PERMIT NO. CPMIF-001 SHINE MEDICAL TECHNOLOGIES, LLC SHINE MEDICAL ISOTOPE PRODUCTION FACILITY DOCKET NO. 50-608 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), October 30, 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 (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities.

In response to the RAI 3.4-6, on pages 92 and 93 of the SHINE Supplement No. 6 and Response to Request for Additional Information, it states that the allowable soil bearing pressure for the building foundation is at least 6,000 pounds per square foot. SHINE concludes that the allowable soil bearing pressure is higher than the foundation contact pressures. It also provides settlement evaluation that is based on the structural analysis results with soil subgrade reaction springs supporting the foundation. SHINE concludes that differential and total settlements are not beyond maximum allowable values.

To support the review of the SHINE operating license application, the staff from Office of Nuclear Reactor Regulation will conduct a virtual regulatory audit related to the SHINE response to RAI 3.4-6 during the week of March 15 to confirm that the allowable soil bearing pressure is higher than the foundation contact pressures, and differential and total settlements of foundations will not exceed maximum allowable values. The specific topics below identify areas where additional information is needed for the NRC staff to continue its review of the SHINE geotechnical engineering topics and may become formal requests for additional information following the March 2021 regulatory audit.

Regulatory Basis and Applicable Guidance Documents SHINE geotechnical engineering topics, as described in the SHINE operating license application, is being evaluated using the following regulations in 10 CFR and guidance:

Enclosure 2

  • Section 50.34(b)(2) of 10 CFR Part 50 requires, in part, that an FSAR include a description and analysis of the structures, systems, and components of the facility, with emphasis upon performance requirements, the bases, and the evaluations required to show that safety functions will be accomplished. The description shall be sufficient to permit understanding of the system designs and their relationship to safety evaluations.

The NRC staffs review of the SHINE geotechnical engineering topics is also based on the following:

  • 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)
  • 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
  • Final 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, dated October 17, 2012 (ADAMS Accession No. ML12156A069)
  • 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)

In particular, the requested information in this regulatory audit is intended to support the NRC staff in making the following evaluation findings in Section 3.4, Seismic Damage, of NUREG-1537, Part 2:

  • The SHINE facility has been designed to protect against seismic damage;
  • There is reasonable assurance that the facility structures, systems, and components (SSCs) will perform the necessary safety functions described and analyzed in the SHINE FSAR; and
  • There is reasonable assurance that the consequences of credible seismic events at the facility are considered (or bounded) by the results of the accident analysis, ensuring acceptable protection of the public health and safety.

Audit Topic The NRC staff seeks to confirm SHINEs conclusion that the allowable soil bearing pressure is higher than the foundation contact pressures, and differential and total settlements are not beyond maximum allowable values. The NRC staff requests the following information to support its review:

1. Analysis and/or calculation of ultimate and allowable soil bearing capacity results with details of model and parameters used and justifications. Comparison of the allowable soil bearing capacity with the maximum foundation contact pressure of Seismic Category I structures obtained from structural response analyses under design loading conditions.
2. Analysis and/or calculation of maximum total and differential settlements of the soil underneath foundations of Seismic Category I structures with details of model and parameters used and justifications based on the soil properties obtained from the geotechnical investigation at the site and the soil pressure transferred from the structures. Comparison of the maximum total and differential settlements with the allowable total and differential settlements of the structures.