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{{#Wiki_filter:UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 8, 2021 Dr. Gregory Piefer, Chief Executive Officer SHINE Medical Technologies, LLC 101 East Milwaukee Street, Suite 600 Janesville, WI 53545
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==SUBJECT:==
SHINE MEDICAL TECHNOLOGIES, LLC - REQUEST FOR ADDITIONAL INFORMATION RELATED METEOROLOGICAL DATA, COOLING SYSTEMS, AND PHYSICAL SECURITY PLAN (EPID NO. L-2019-NEW-0004)
 
==Dear Dr. Piefer:==
 
By {{letter dated|date=July 17, 2019|text=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 (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities.
During the NRC staffs review of SHINEs operating license application, questions have arisen for which additional information is needed. The enclosed request for additional information (RAI) identifies information needed for the NRC staff to continue its review of the SHINE final safety analysis report (FSAR), submitted as part of the operating license application, and prepare a safety evaluation report. The specific chapters of the SHINE operating license application covered by this RAI includes the following:
* Chapter 2, Site Characteristics
* Chapter 4, Irradiation Unit and Radioisotope Production Facility Description
* Physical Security Plan  to this letter contains publicly available RAIs related to SHINE FSAR Chapters 2 and 4. Enclosure 2 to this letter contains non-public security-related information related to SHINEs physical security plan. It is requested that SHINE provide responses to the enclosed RAI within 30 days from the date of this letter. 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
 
G. Piefer                                      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 additional 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 RAIs 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 301-415-1524, or by electronic mail at Steven.Lynch@nrc.gov.
Sincerely, Steven T.            Digitally signed by Steven T. Lynch Lynch                Date: 2021.04.08 17:55:42 -04'00' 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
 
==Enclosures:==
 
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
 
PKG: ML21089A000                                    NRR-088 OFFICE        NRR/DANU/PM    NRR/DANU/LA    NRR/DANU/BC NRR/DANU/BC (A) NRR/DANU/PM NAME          SLynch          NParker        TTate      DHardesty      SLynch DATE          3/31/2021        4/1/2021        4/08/2021  4/08/2021      4/08/2021 OFFICE OF NUCLEAR REACTOR REGULATION REQUEST FOR ADDITIONAL 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|date=July 17, 2019|text=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 (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities.
During the NRC staffs review of the SHINE operating license application, questions have arisen for which additional information is needed. This request for additional information (RAI) identifies information needed for the NRC staff to continue its review of the SHINE final safety analysis report (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 RAI include the following:
* Chapter 2, Site Characteristics
* Chapter 4, Irradiation Unit and Radioisotope Production Facility Description Applicable Regulatory Requirements and Guidance Documents The NRC staff is reviewing the SHINE operating license application, which describes the SHINE irradiation facility, including the irradiation units, and radioisotope production facility, 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 Enclosure 1
 
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.
For the purposes of this review, the term reactor, as it appears in NUREG-1537, the ISG Augmenting NUREG-1537, and other relevant guidance can be interpreted to refer to SHINEs irradiation unit, irradiation facility, or radioisotope production facility, as appropriate within the context of the application and corresponding with the technology described by SHINE in its application. Similarly, for the purposes of this review, the term reactor fuel, as it appears in the relevant guidance listed above, may be interpreted to refer to SHINEs target solution.
Responses to the following RAI are needed to continue the review of the SHINE operating license application.
 
Chapter 2 - Site Characteristics SHINE FSAR Section 2.3, Meteorology The following regulatory requirement is applicable to RAIs 2.3-1 and 2.3-2:
Paragraph (a)(1) of 10 CFR 20.1301, Dose Limits for Individual Members of the Public, states, in part, that [e]ach license shall conduct operations such that [t]he total effective dose equivalent to individual members of the public from the licensed operation does not exceed 0.1 rem (1 mSv) in a year.
The requests for information that follow are intended to confirm that SHINE has provided and developed sufficient analyses applicable to and commensurate with the risks of the dispersion of airborne releases of radioactive material in the unrestricted environment at the site, and any doses received by members of the public are within the regulatory limits of 10 CFR Part 20, Standards for Protection against Radiation.
RAI 2.3-1        The acceptance criteria for Section 2.3, Meteorology, of NUREG-1537, Part 2, states, in part, that the information on meteorology, and local weather conditions is sufficient to support dispersion analyses for postulated airborne releases.
As stated, in part, in Section 2.3.2.2, Local Data Sources, of the SHINE FSAR,
[s]urface meteorological data were available from the Southern Wisconsin Regional Airport (SWRA) in Janesville, Wisconsin (NOAA station identifier KJVL), and were used to support relative atmospheric concentration and radiological dose assessments. Regulatory Guide (RG) 1.23, Meteorological Monitoring Programs for Nuclear Power Plants, provides guidance for designing and operating an onsite meteorological measurements program, including the resolution and specification for meteorological instrumentation. Although there is no requirement that SHINE use RG 1.23, or follow the guidance therein, the RG provides the basis for the meteorology data used in NRC-approved atmospheric dispersion models. With this in mind, the NRC staff developed the following information requests to confirm the quality and appropriate use of the meteorological data from the SWRA in SHINEs dispersion modeling:
: a. SHINE has provided wind direction, as shown in the Annual Wind Rose data from the SWRA in Figure 2.3 of the SHINE FSAR, only by wind direction sector (N, NNW, NW, etc.), and not discrete degrees, resulting in wind directions being recorded every 22.5 degrees.
Discuss and account for any bias introduced by using wind direction sector rather than discrete wind direction degrees.
: b. Wind speed instrumentation at National Weather Service stations or airfields may have insufficient resolution at lower wind speeds which could result in underestimated X/Q values.
Discuss the resolution of the SWRA wind speed instrumentation and its acceptability for accurately calculating the X/Q values.
: c. As discussed in FSAR Section 2.3.2.5, Atmospheric Stability, SHINE determined stability classes using the Turner 1964 method. However, the vertical temperature difference is the preferred method for determining Pasquill stability classes for NRC licensing purposes, as specified in RG 1.145, Atmospheric Dispersion Models for Potential Accident Consequence Assessments at Nuclear Power Plants, Revision 1, Section 1.1, Meteorological Data Input.
Discuss any differences in the parameters and approach SHINE used to determine atmospheric stability via the Turner 1964 method as compared to the vertical temperature difference method. Discuss any bias introduced into the dispersion results by using the Turner 1964 method.
RAI 2.3-2      The acceptance criteria for Section 2.3 of NUREG-1537, Part 2, states, in part, that [h]istorical summaries of local meteorological data based on available onsite measurements and National Weather Service station summaries or summaries from other nearby sources are presented.
As stated in part, in Section 2.3.2.2 of the SHINE FSAR, [s]urface meteorological data were available from the Southern Wisconsin Regional Airport (SWRA) in Janesville, Wisconsin (NOAA station identifier KJVL) and were used to support relative atmospheric concentration and radiological dose assessments. However, the NRC staff is seeking additional information to confirm that the data used by SHINE is representative of onsite conditions for the facility.
Discuss the representativeness of the offsite meteorological measurements for the local conditions at the SHINE site, specifically addressing the dispersion characteristics of the modeled releases. Note any differences in dispersion characteristics between the SHINE site and the Southern Wisconsin Regional Airport.
The information requested in RAIs 2.3-1 and 2.3-2 is necessary to support the NRC staffs evaluation findings, consistent with Section 2.3 of NUREG-1537, Part 2. Specifically, the requested information is intended to support the NRC staffs determination that meteorological information presented by SHINE in its FSAR is sufficient to support analyses applicable to and commensurate with the risks of the dispersion of airborne releases of radioactive material in the unrestricted environment at the site. The methods and assumptions are applied to releases from both normal facility operations and postulated accidents at the facility.
 
Chapter 4 - Irradiation Unit and Radioisotope Production Facility Description RAI 4a-15  Paragraph (b)(2) of Section 50.34, Contents of applications; technical information, to 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 ISG to NUREG-1537, Part 2, Section 4a2.6, "Thermal-Hydraulic Design, states that the criteria for the thermal-hydraulic design should include that there be no coolant flow instability in any cooling coil that could lead to a decrease in cooling, and that the departure from nucleate boiling (DNB) ratio should be no less than 2.0 along a cooling coil. The NRC staff did not identify information in the FSAR to confirm that that any primary closed loop cooling system (PCLS) heat transfer surface, under any design conditions, will not undergo DNB.
Clarify whether any PCLS cooling surface, considering all system design conditions, could exceed critical heat flux resulting in DNB. If so, explain how such a condition is prevented and mitigated. If not, explain how much margin is available to avoid DNB in the worse-case scenario.
This information is necessary to confirm that primary coolant hydraulics and thermal conditions have been specified for the SHINE facility, consistent with the evaluation findings in the ISG to NUREG-1537, Part 2, Section 4a2.6. The analysis provided by the applicant should consider the various approaches and systems for heat removal, such as the cooling coils, the pool, and the gas management system. The analyses should give the limiting conditions of the features that ensure barrier integrity.}}

Revision as of 20:25, 8 September 2021

Shine Medical Technologies, LLC - Request for Additional Information Related to Meteorological Data, Cooling Systems, and Physical Security
ML21089A001
Person / Time
Site: SHINE Medical Technologies
Issue date: 04/08/2021
From: Steven Lynch
NRC/NRR/DANU/UNPL
To: Piefer G
SHINE Medical Technologies
Lynch S
Shared Package
ML21089A000 List:
References
EPID L-2019-NEW-0004
Download: ML21089A001 (9)
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