Safety Evaluation Report

Related to SHINE Medical 

Technologies, Inc. Construction 

Permit Application for a Medical 

Radioisotope Production Facility

Docket Number 50-608

Office of Nuclear Reactor Regulation

NUREG-2189

 

Safety Evaluation Report

Related to SHINE Medical 

Technologies, Inc. Construction 

Permit Application for a Medical 

Radioisotope Production Facility

Docket Number 50-608

Manuscript Completed: October 2015

Date Published: August 2016

Office of Nuclear Reactor Regulation

NUREG-2189

 

iii

ABSTRACT

This safety evaluation report (SER) documents the U.S Nuclear Regulatory Commission (NRC) 

staff’s technical review of the construction permit application submitted by SHINE Medical 

Technologies, Inc. (SHINE or the applicant) for a medical radioisotope production facility to be 

located in Janesville, Wisconsin. The proposed facility would comprise an irradiation facility (IF) 

and radioisotope production facility (RPF) for the irradiation and processing of special nuclear 

material to produce medical radioisotopes, such as molybdenum-99. The IF would consist of 

eight subcritical operating assemblies (or irradiation units [IUs]), which would each be licensed 

as utilization facilities as defined in Title 10 of the Code of Federal Regulations (10 CFR) 50.2, 

“Definitions.” The RPF would consist of three hot cell structures, licensed collectively as a 

production facility, as defined in 10 CFR 50.2. In this SER, the IF and RPF are collectively 

referred to as the SHINE facility. 

The staff’s environmental review of the SHINE construction permit application is documented in 

NUREG-2183, “Final Environmental Impact Statement for the Construction Permit for the 

SHINE Medical Radioisotope Production Facility.” A record of decision will be published at a 

future date concerning the proposed issuance of the construction permit.

This SER presents the results of the staff’s review of the SHINE construction permit application, 

as supplemented by the applicant’s responses to requests for additional information (RAIs), and 

as updated on August 27, 2015. 

The NRC’s Advisory Committee on Reactor Safeguards (ACRS) independently reviewed those 

aspects of the application that concern safety and provided the results of its review to the 

Commission in a report dated October 15, 2015. Appendix D, “Report by the Advisory 

Committee on Reactor Safeguards,” to this SER includes a copy of the report by the ACRS on 

the SHINE construction permit application.

Based upon the review documented in the SER, the staff finds that the preliminary design and 

analysis of the SHINE IF and RPF, including the principal design criteria; design bases; 

information relative to materials of construction, general arrangement, and approximate 

dimensions; and preliminary analysis and evaluation of the design and performance of 

structures, systems, and components (SSCs) of the facility, as described in the SHINE 

preliminary safety analysis report, and as supplemented by responses to RAIs: (1) provides 

reasonable assurance that the final design will conform to the design basis; (2) includes an 

adequate margin of safety; (3) SSCs adequately provide for the prevention of accidents and the 

mitigation of consequences of accidents; and (4) meets applicable regulatory requirements as 

well as NRC guidance. Therefore, the staff recommends that the Commission make the 

necessary findings with respect to the safety of the construction permit in accordance with 

10 CFR 50.35, “Issuance of construction permits”; 50.40, “Common standards”; and 50.50, 

“Issuance of licenses and construction permits.”

v

CONTENTS

Areas of Review ................................................................................ 1-2

Regulatory Basis and Acceptance Criteria......................................... 1-3

Review Procedures ........................................................................... 1-6

Resolving Technical Issues ............................................................... 1-7

Ongoing Research and Development................................................ 1-8

Advisory Committee on Reactor Safeguards Review......................... 1-8

Application Availability ....................................................................... 1-9

NRC Staff Contact Information .......................................................... 1-9

Applicable Regulatory Requirements................................................. 2-9

Regulatory Guidance and Acceptance Criteria .................................. 2-9

Geography and Demography .......................................................... 2-10

Nearby Industrial, Transportation, and Military Facilities.................. 2-11

Meteorology..................................................................................... 2-15

Hydrology ........................................................................................ 2-16

Geology, Seismology, and Geotechnical Engineering ..................... 2-20

Applicable Regulatory Requirements................................................. 3-4

Regulatory Guidance and Acceptance Criteria .................................. 3-4

Design Criteria................................................................................... 3-5
vi

Meteorological Damage..................................................................... 3-7

Water Damage .................................................................................. 3-8

Seismic Damage ............................................................................... 3-9

Systems and Components............................................................... 3-17

4a.1 Areas of Review ................................................................................ 4-1

4a.2 Summary of Application..................................................................... 4-2

4a.3 Regulatory Basis and Acceptance Criteria......................................... 4-2

4a.3.1 Applicable Regulatory Requirements .................................. 4-3

4a.3.2 Regulatory Guidance and Acceptance Criteria.................... 4-3

4a.4 Review Procedures, Technical Evaluation, and Evaluation 

Findings............................................................................................. 4-4

4a.4.1 Summary Description.......................................................... 4-5

4a.4.2 Subcritical Assembly ........................................................... 4-5

4a.4.3 Target Solution.................................................................... 4-5

4a.4.4 Reactivity Control Mechanisms ........................................... 4-9

4a.4.5 Solid Neutron Moderator and Reflector ............................. 4-10

4a.4.6 Subcritical Multiplication Source........................................ 4-10

4a.4.7 Subcritical Assembly Support Structures........................... 4-11

4a.4.8 Neutron Multiplier.............................................................. 4-12

4a.4.9 Neutron Driver................................................................... 4-12

4a.4.10 Target Solution Vessel and Light Water Pool .................... 4-14

4a.4.11 Irradiation Facility Biological Shield ................................... 4-16

4a.4.12 Nuclear Design ................................................................. 4-17

4a.4.13 Thermal-Hydraulic Design................................................. 4-23

4a.4.14 Gas Management System................................................. 4-27

4a.4.15 Probable Subjects of Technical Specifications .................. 4-30

4a.5 Summary and Conclusions.............................................................. 4-30

4b.1 Areas of Review .............................................................................. 4-31

4b.2 Summary of Application................................................................... 4-32

4b.3 Regulatory Basis and Acceptance Criteria....................................... 4-32

4b.4 Review Procedures, Technical Evaluation, and Evaluation 

Findings........................................................................................... 4-32

4b.4.1 Facility and Process Description ....................................... 4-32

4b.4.2 Radioisotope Production Facility Biological Shield ............ 4-34

4b.4.3 Radioisotope Extraction System........................................ 4-35

4b.4.4 Special Nuclear Material Processing and Storage............. 4-36

4b.4.5 Processing of Unirradiated Special Nuclear Material......... 4-38

4b.5 Summary and Conclusions.............................................................. 4-39

5a.1 Areas of Review ................................................................................ 5-1

5a.2 Summary of Application..................................................................... 5-2

5a.3 Regulatory Basis and Acceptance Criteria......................................... 5-3

5a.3.1 Applicable Regulatory Requirements .................................. 5-4
vii

5a.3.2 Regulatory Guidance and Acceptance Criteria.................... 5-4

5a.4 Review Procedures, Technical Evaluation, and Evaluation 

Findings............................................................................................. 5-5

5a.4.1 Summary Description.......................................................... 5-6

5a.4.2 Primary Cooling System...................................................... 5-6

5a.4.3 Secondary Cooling System................................................. 5-9

5a.4.4 Primary Coolant Cleanup .................................................. 5-10

5a.4.5 Primary Coolant Makeup Water System............................ 5-11

5a.4.6 Nitrogen-16 Control........................................................... 5-11

5a.4.7 Auxiliary Systems Using Primary Coolant ......................... 5-12

5a.4.8 Probable Subjects of Technical Specifications .................. 5-12

5a.5 Summary and Conclusions.............................................................. 5-13

5b.1 Areas of Review .............................................................................. 5-14

5b.2 Summary of Application................................................................... 5-14

5b.3 Regulatory Basis and Acceptance Criteria....................................... 5-14

5b.4 Review Procedures, Technical Evaluation, and Evaluation 

Findings........................................................................................... 5-14

5b.5 Summary and Conclusions.............................................................. 5-14

6a.1 Areas of Review ................................................................................ 6-1

6a.2 Summary of Application..................................................................... 6-2

6a.3 Regulatory Basis and Acceptance Criteria......................................... 6-2

6a.3.1 Applicable Regulatory Requirements .................................. 6-3

6a.3.2 Regulatory Guidance and Acceptance Criteria.................... 6-3

6a.4 Review Procedures, Technical Evaluation, and Evaluation 

Findings............................................................................................. 6-4

6a.4.1 Summary Description.......................................................... 6-5

6a.4.2 Confinement........................................................................ 6-6

6a.4.3 Containment...................................................................... 6-16

6a.4.4 Emergency Cooling System.............................................. 6-16

6a.4.5 Probable Subjects of Technical Specifications .................. 6-16

6a.5 Summary and Conclusions.............................................................. 6-18

6b.1 Areas of Review .............................................................................. 6-19

6b.2 Summary of Application................................................................... 6-19

6b.3 Regulatory Basis and Acceptance Criteria....................................... 6-20

6b.3.1 Applicable Regulatory Requirements ................................ 6-21

6b.3.2 Regulatory Guidance and Acceptance Criteria.................. 6-22

6b.4 Review Procedures, Technical Evaluation, and Evaluation 

Findings........................................................................................... 6-22

6b.4.1 Summary Description........................................................ 6-23

6b.4.2 Confinement...................................................................... 6-24

6b.4.3 Containment...................................................................... 6-30

6b.4.4 Emergency Cooling System.............................................. 6-30

6b.4.5 Nuclear Criticality Safety ................................................... 6-30

6b.4.6 Probable Subjects of Technical Specifications .................. 6-42

6b.5 Summary and Conclusions.............................................................. 6-43
viii

7a.1 Areas of Review ................................................................................ 7-1

7a.2 Summary of Application..................................................................... 7-2

7a.3 Regulatory Basis and Acceptance Criteria......................................... 7-2

7a.3.1 Applicable Regulatory Requirements .................................. 7-3

7a.3.2 Regulatory Guidance and Acceptance Criteria.................... 7-3

7a.4 Review Procedures, Technical Evaluation, and Evaluation 

Findings............................................................................................. 7-4

7a.4.1 Summary Description.......................................................... 7-5

7a.4.2 Design of Instrumentation and Control Systems.................. 7-6

7a.4.3 Target Solution Vessel Process Control Description ......... 7-10

7a.4.4 Target Solution Vessel Reactivity Protection System ........ 7-11

7a.4.5 Engineered Safety Features Actuation System ................. 7-12

7a.4.6 Control Console and Display Information .......................... 7-13

7a.4.7 Radiation Monitoring Systems........................................... 7-14

7a.4.8 Probable Subjects of Technical Specifications .................. 7-14

7a.5 Summary and Conclusions.............................................................. 7-15

7b.1 Areas of Review .............................................................................. 7-16

7b.2 Summary of Application................................................................... 7-16

7b.3 Regulatory Basis and Acceptance Criteria....................................... 7-16

7b.3.1 Applicable Regulatory Requirements ................................ 7-17

7b.3.2 Regulatory Guidance and Acceptance Criteria.................. 7-18

7b.4 Review Procedures, Technical Evaluation, and Evaluation 

Findings........................................................................................... 7-19

7b.4.1 Summary Description........................................................ 7-19

7b.4.2 Design of Instrumentation and Control Systems................ 7-20

7b.4.3 Production Facility Process Control Systems .................... 7-20

7b.4.4 Engineered Safety Feature and Alarming.......................... 7-22

7b.4.5 Control Console and Display Instrumentation.................... 7-23

7b.4.6 Radiation Monitoring Systems........................................... 7-24

7b.4.7 Probable Subjects of Technical Specifications .................. 7-24

7b.5 Summary and Conclusions.............................................................. 7-25

8a.1 Areas of Review ................................................................................ 8-1

8a.2 Summary of Application..................................................................... 8-2

8a.3 Regulatory Basis and Acceptance Criteria......................................... 8-3

8a.3.1 Applicable Regulatory Requirements .................................. 8-4

8a.3.2 Regulatory Guidance and Acceptance Criteria.................... 8-4

8a.4 Review Procedures, Technical Evaluation, and Evaluation 

Findings............................................................................................. 8-5

8a.4.1 Normal Electrical Power Systems ....................................... 8-5

8a.4.2 Emergency Electrical Power Systems................................. 8-6

8a.4.3 Probable Subjects of Technical Specifications .................... 8-8

8a.5 Summary and Conclusions................................................................ 8-9

8b.1 Areas of Review .............................................................................. 8-10
ix

8b.2 Summary of Application................................................................... 8-10

8b.3 Regulatory Basis and Acceptance Criteria....................................... 8-10

8b.4 Review Procedures, Technical Evaluation, and Evaluation 

Findings........................................................................................... 8-10

8b.4.1 Normal Electrical Power Systems ..................................... 8-11

8b.4.2 Emergency Electrical Power Systems............................... 8-13

8b.4.3 Probable Subjects of Technical Specifications .................. 8-14

8b.5 Evaluation Findings and Conclusions .............................................. 8-14

9a.1 Areas of Review ................................................................................ 9-1

9a.2 Summary of Application..................................................................... 9-2

9a.3 Regulatory Basis and Acceptance Criteria......................................... 9-4

9a.3.1 Applicable Regulatory Requirements .................................. 9-5

9a.3.2 Regulatory Guidance and Acceptance Criteria.................... 9-5

9a.4 Review Procedures, Technical Evaluation, and Evaluation 

Findings............................................................................................. 9-6

9a.4.1 Heating, Ventilation, and Air Conditioning Systems............. 9-7

9a.4.2 Handling and Storage of Target Solution............................. 9-9

9a.4.3 Fire Protection Systems and Programs............................. 9-10

9a.4.4 Communication Systems................................................... 9-13

9a.4.5 Possession and Use of Byproduct, Source, and 

Special Nuclear Material ................................................... 9-13

9a.4.6 Cover Gas Control in Closed Primary Coolant 

Systems ............................................................................ 9-14

9a.4.7 Other Auxiliary Systems.................................................... 9-14

9a.4.8 Probable Subjects of Technical Specifications .................. 9-15

9a.5 Summary and Conclusion................................................................ 9-16

9b.1 Areas of Review .............................................................................. 9-16

9b.2 Summary of Application................................................................... 9-17

9b.3 Regulatory Basis and Acceptance Criteria....................................... 9-19

9b.4 Review Procedures, Technical Evaluation, and Evaluation 

Findings........................................................................................... 9-19

9b.4.1 Heating, Ventilation, and Air Conditioning Systems........... 9-19

9b.4.2 Handling and Storage of Target Solution........................... 9-19

9b.4.3 Fire Protection Systems and Programs............................. 9-20

9b.4.4 Communication Systems................................................... 9-20

9b.4.5 Possession and Use of Byproduct, Source, and 

Special Nuclear Material ................................................... 9-20

9b.4.6 Cover Gas Control in Closed Primary Coolant 

Systems ............................................................................ 9-21

9b.4.7 Other Auxiliary Systems.................................................... 9-22

9b.4.8 Probable Subjects of Technical Specifications .................. 9-24

9b.5 Summary and Conclusions.............................................................. 9-25
x

Applicable Regulatory Requirements............................................... 11-9

Regulatory Guidance and Acceptance Criteria .............................. 11-10

Radiation Sources ......................................................................... 11-11

Radiation Protection Program........................................................ 11-19

ALARA Program............................................................................ 11-20

Radiation Monitoring and Surveying .............................................. 11-22

Radiation Exposure Control and Dosimetry ................................... 11-25

Contamination Control................................................................... 11-30

Environmental Monitoring.............................................................. 11-31

Radioactive Waste Management Program .................................... 11-34

Radioactive Waste Controls .......................................................... 11-35

Release of Radioactive Waste....................................................... 11-40

Respiratory Protection Program..................................................... 11-41

Probable Subjects of Technical Specifications............................... 11-44

Applicable Regulatory Requirements............................................... 12-4

Regulatory Guidance and Acceptance Criteria ................................ 12-5

Organization.................................................................................... 12-6

Review and Audit Activities.............................................................. 12-8

Procedures.................................................................................... 12-10

Required Actions ........................................................................... 12-11

Reports.......................................................................................... 12-11

Records......................................................................................... 12-12

Emergency Planning ..................................................................... 12-12

Security Planning........................................................................... 12-33

Quality Assurance ......................................................................... 12-33

Operator Training and Requalification ........................................... 12-44

Startup Plan................................................................................... 12-45

Environmental Reports .................................................................. 12-45

Material Control and Accounting Plan............................................ 12-45

13a.1 Areas of Review .............................................................................. 13-1

13a.2 Summary of Application................................................................... 13-2

13a.3 Regulatory Basis and Acceptance Criteria....................................... 13-3

13a.3.1 Applicable Regulatory Requirements ................................ 13-3

13a.3.2 Regulatory Guidance and Acceptance Criteria.................. 13-4

13a.4 Review Procedures, Technical Evaluation, and Evaluation 

Findings........................................................................................... 13-5

13a.4.1 Maximum Hypothetical Accident ....................................... 13-6
xi

13a.4.2 Insertion of Excess Reactivity/Inadvertent Criticality.......... 13-9

13a.4.3 Reduction in Cooling....................................................... 13-11

13a.4.4 Mishandling or Malfunction of Target Solution................. 13-13

13a.4.5 Loss of Electrical Power.................................................. 13-15

13a.4.6 External Events............................................................... 13-15

13a.4.7 Mishandling or Malfunction of Equipment........................ 13-16

13a.4.8 Large Undamped Power Oscillations .............................. 13-18

13a.4.9 Detonation and Deflagration............................................ 13-19

13a.4.10 Unintended Exothermic Chemical Reactions 

Other Than Explosion ..................................................... 13-20

13a.4.11 Primary System Boundary System Interaction 

Events............................................................................. 13-20

13a.4.12 Inadvertent Exposure to Neutrons from the 

Neutron Driver................................................................. 13-21

13a.4.13 Irradiation Facility Fires ................................................... 13-22

13a.4.14 Tritium Purification System (TPS) Design Basis 

Accident.......................................................................... 13-23

13a.4.15 Probable Subjects of Technical Specifications ................ 13-25

13a.5 Summary and Conclusions............................................................ 13-26

13b.1 Areas of Review ............................................................................ 13-27

13b.2 Summary of Application................................................................. 13-28

13b.3 Regulatory Basis and Acceptance Criteria..................................... 13-29

13b.3.1 Applicable Regulatory Requirements .............................. 13-30

13b.3.2 Regulatory Guidance and Acceptance Criteria................ 13-30

13b.4 Review Procedures, Technical Evaluation, and Evaluation 

Findings......................................................................................... 13-31

13b.4.1 Processes Conducted Outside of the Irradiation 

Facility............................................................................. 13-32

13b.4.2 Accident Initiating Events ................................................ 13-34

13b.4.3 Maximum Hypothetical Accident ..................................... 13-37

13b.4.4 Loss of Containment ....................................................... 13-38

13b.4.5 Loss of Normal Electric Power ........................................ 13-38

13b.4.6 External Events............................................................... 13-39

13b.4.7 Mishandling or Malfunction of Equipment........................ 13-40

13b.4.8 Inadvertent Nuclear Criticality in the Radioisotope 

Production Facility........................................................... 13-41

13b.4.9 Radioisotope Production Facility Fire .............................. 13-42

13b.4.10 Analyses of Accidents with Hazardous Chemicals 

Produced from Licensed Material.................................... 13-43

13b.4.11 Probable Subjects of Technical Specifications ................ 13-44

13b.5 Summary and Conclusions............................................................ 13-44

Applicable Regulatory Requirements............................................... 14-3

Regulatory Guidance and Acceptance Criteria ................................ 14-3
xii

Applicable Regulatory Requirements............................................... 15-2

Regulatory Guidance and Acceptance Criteria ................................ 15-2

Financial Ability to Construct the SHINE Facility.............................. 15-3

Financial Ability to Operate the SHINE Facility ................................ 15-5

Financial Ability To Decommission the SHINE Facility..................... 15-5

Foreign Ownership, Control, or Domination (FOCD)........................ 15-6

Nuclear Insurance and Indemnity .................................................... 15-6
xiii

FIGURES

Figure 2.1-1. City of Janesville........................................................................................2-3

Figure 2.2-2. SHINE Facility ― General Location Map ...................................................2-4

Figure 2.2-3. Nearby Industrial and Transportation Facilities ..........................................2-6

TABLES

Table 2.2-1. Total Crash Probability ............................................................................2-13

Table 6a2.2-11-1. Comparison of Unmitigated and Mitigated Radiological Doses for 

IF DBAs ...................................................................................................6-13

Table 6b.2-6-1. Comparison of Unmitigated and Mitigated Radiological Doses for 

RPF DBAs ...............................................................................................6-26

Table 6b-1. Summary of USL Determination ..............................................................6-36

Table 6b-2. Area of Applicability Summary .................................................................6-37

xv

ABBREVIATIONS AND ACRONYMS

°C degrees Celsius

°F degrees Fahrenheit

1/M inverse subcritical multiplication factor

A ampere

AC alternating current

ACI American Concrete Institute

ACRS Advisory Committee on Reactor Safeguards

ADAMS Agencywide Documents Access and Management System

AHR aqueous homogeneous reactor

ALARA as low as is reasonably achievable

ALOHA Areal Locations of Hazardous Atmospheres

ANS American Nuclear Society

ANSI American National Standards Institute

AOA area of applicability

APF assigned protection factor

ASCE American Society of Civil Engineers

ASME American Society of Mechanical Engineers

ASTM American Society for Testing and Materials

BPVC Boiler and Pressure Vessel Code

CAAS criticality accident and alarm system

CAMS continuous air monitoring system

CEUS-SSC Central and Eastern United States Seismic Source Characterization for 

Nuclear Facilities

CFD computational fluid dynamics

CFR Code of Federal Regulations

cm centimeter(s)

COO Chief Operating Officer

COV coefficient of variation

DAC derived air concentration

DBA design-basis accident

DC direct current

DOE U.S. Department of Energy

DOT U.S. Department of Transportation

EAL emergency action level

ED Emergency Director

EIS environmental impact statement

EPA U.S. Environmental Protection Agency

EPIP emergency plan implementing procedure

EPRI Electric Power Research Institute

EPZ Emergency Planning Zone

ERO Emergency Response Organization

ESC emergency support center

ESF engineered safety feature

ESFAS engineered safety feature actuation system

FA Fire Area

FAA Federal Aviation Administration

FCHS facility chilled water supply and distribution system

FHA fire hazards analysis
xvi

ft feet

FMEA failure modes and effects analysis

FOCD foreign ownership, control, or domination

FPS fire protection system

FQ financial qualification

FR Federal Register

FSAR final safety analysis report

FVZ4 facility ventilation Zone 4

GBE best-estimate (mean) soil properties

GLB lower bound soil properties

GUB upper bound soil properties

GDC General Design Criteria (Criterion)

gpm gallons per minute

HAZOPS hazards and operability study

HEPA high-efficiency particulate air

HRA high radiation area

HVAC heating, ventilation, and air conditioning

HVPS high voltage power supply

Hz hertz

I&C instrumentation and control

IAEA International Atomic Energy Agency

ICRP International Commission on Radiation Protection

IE initiating event

IEEE Institute of Electrical and Electronics Engineers

IF irradiation facility

IMR Issue Management Report

IROFS items relied on for safety

ISA integrated safety analysis

ISG interim staff guidance

IU irradiation unit

keff effective neutron multiplication factor

kg/m2 kilograms per square meter

km kilometer(s)

kPa kilopascal(s)

kV kilovolt(s)

kVA kilovoltampere(s)

LANL Los Alamos National Laboratory

lb/ft2 pounds per square foot

LCO limiting conditions of operation

LEU low-enriched uranium

LOOP loss of off-site power

LSSS limiting safety system settings

LWPS light-water pool system

m meter(s)

M&TE measuring and test equipment

MC&A material control and accounting

MCC motor control center

MCNP Monte Carlo N-Particle computer code

MEI maximally exposed individual

MEPS molybdenum extraction and purification system

MeV million electron volts
xvii

mg milligrams

MHA maximum hypothetical accident

mi mile(s)

MIPF Medical Isotope Production Facility

MIPS molybdenum isotope product packaging system

MMI Modified Mercalli Intensity

Mo-99 molybdenum-99

mrem millirem

mrem/hr millirem per hour

MUPS light water pool and primary closed loop cooling make-up system

N-16 nitrogen-16

NCS nuclear criticality safety

NCSE nuclear criticality safety evaluation

NCSP Nuclear Criticality Safety Program

NDAS neutron driver assembly system

NEC National Electrical Code

NFDS neutron flux detection system

NFPA National Fire Protection Association

NGRS noble gas removal system

NRC U.S. Nuclear Regulatory Commission

OLWS organic liquid waste storage and export

ORNL Oak Ridge National Laboratory

PAG protective action guideline (EPA)

PCLS primary closed loop cooling system

PHA preliminary hazard analysis

PMF probable maximum flood

PMP probable maximum precipitation

PSAR preliminary safety analysis report

PSB primary system boundary

psi pounds per square inch

PSTS probably subjects of technical specifications

Pu plutonium

PUREX plutonium and uranium extraction

PVVS process vessel vent system

QA quality assurance

QAP Quality Assurance Plan

QAPD Quality Assurance Program Description

RAI request for additional information

RAMS radiation area monitoring system

RCA radiologically controlled area

RDS radioactive drain system

rem roentgen equivalent man

REMP radiological environmental monitoring program

RICS radiological integrated control system

RLWE radioactive liquid waste evaporation and immobilization system

RLWS radioactive liquid waste storage

RP radiation protection

RPCS radioisotope production facility primary cooling system

RPF radioisotope production facility

RPM Radiation Protection Manager

RTF Radioiodine Test Facility
xviii

RV radiologically controlled area (RCA) ventilation system

RVZ1 radiologically controlled area (RCA) ventilation system Zone 1

RVZ2 radiologically controlled area (RCA) ventilation system Zone 2

RVZ3 radiologically controlled area (RCA) ventilation system Zone 3

RWP radiation work permit

SAR safety analysis report

SASS subcritical assembly support structure

SASSI Structural Analysis Software System Interface

SCAS subcritical assembly system

SCL Saint Charles Lineament

SDG standby diesel generator

SER safety evaluation report

SHINE SHINE Medical Technologies, Inc.

SIXEP site ion exchange effluent plant

SL safety limit

SNM special nuclear material

SRM stack release monitoring

SRWP solid radioactive waste packaging system

SSCs structures, systems, and components

SWRA Southern Wisconsin Regional Airport

TBP tributyl phosphate

TDN thermal denitration

TEDE total effective dose equivalent

TOGS target solution vessel (TSV) off-gas system 

TPCS target solution vessel (TSV) process control system

TPS tritium purification system 

TRCS target solution vessel (TSV) reactivity control system

TRPS target solution vessel (TSV) reactivity protection system 

TS technical specifications

TSPS target solution preparation system

TSV target solution vessel

U-233 uranium-233

U-235 uranium-235

U-238 uranium-238

UNCS uranyl nitrate conversion system

UNP uranyl nitration preparation

UPSS uninterruptible power supply system

UREX uranium extraction

USGS U.S. Geological Survey

VAC volts – alternating current

VDC volts – direct current

VHRA very high radiation area

yr year
1-1

THE FACILITY

This chapter of the safety evaluation report (SER) is a general introduction to the facility and an 

overview of the topics covered in detail in other chapters of this SER, including areas of review, 

regulatory criteria and guidance, review procedures and findings, and conclusions. 

Introduction

This SER documents the results of the U.S Nuclear Regulatory Commission (NRC) staff’s (the 

staff’s) technical review of the construction permit application submitted by SHINE Medical 

Technologies, Inc. (SHINE or the applicant) under Title 10 of the Code of Federal Regulations

(10 CFR) Part 50, “Domestic Licensing of Production and Utilization Facilities,” for a medical 

radioisotope production facility. The proposed facility would consist of an irradiation facility (IF) 

and radioisotope production facility (RPF) for the irradiation and processing of special nuclear 

material to produce medical radioisotopes, such as molybdenum-99. The IF would consist of 

eight subcritical operating assemblies (or irradiation units [IUs]), which would each be licensed 

as utilization facilities as defined 10 CFR 50.2, “Definitions.” The RPF would consist of three hot 

cell structures, licensed collectively as a production facility, as defined in 10 CFR 50.2. In this 

SER, the IF and RPF are collectively referred to as the SHINE facility. An environmental review 

was also performed of the SHINE construction permit application and its evaluation and 

conclusions are documented in an environmental impact statement, published as NUREG-2183, 

“Final Environmental Impact Statement for the Construction Permit for the SHINE Medical 

Radioisotope Production Facility.”

By letter dated March 26, 2013 (Reference 2), SHINE submitted Part 1 of a two-part application 

for a construction permit, which, if granted, would allow SHINE to construct a medical 

radioisotope production facility in Janesville, Wisconsin. The NRC staff acknowledged receipt of 

Part 1 of SHINE’s two-part application for a construction permit under 10 CFR Part 50 in the 

Federal Register (FR) (78 FR 29390) on May 20, 2013. An exemption from certain 

requirements of 10 CFR 2.101, “Filing of application,” paragraph (a)(5) was granted by the 

Commission on March 20, 2013 (Reference 8), in response to a letter from SHINE dated 

February 18, 2013 (Reference 9). The exemption allowed SHINE to submit its construction 

permit application in two parts. Specifically, the exemption allowed SHINE to submit a portion of 

its application for a construction permit up to 6 months prior to the remainder of the application 

regardless of whether or not an environmental impact statement or a supplement to an 

environmental impact statement is prepared. In accordance with 10 CFR 2.101(a)(5), SHINE 

submitted the following in part one of its construction permit application:

• Description and safety assessment of the site required by 10 CFR 50.34, “Contents of 

applications; technical information,” paragraph (a)(1).

• Environmental report required by 10 CFR 50.30, “Filing of applications for licenses; oath 

or affirmation,” paragraph (f).

• Filing fee information required by 10 CFR 50.30(e) and 10 CFR 170.21, “Schedule of 

fees for production or utilization facilities, review of standard referenced design 

approvals, special projects, inspections, and import and export licenses.”
The Facility

1-2

• General information required by 10 CFR 50.33, “Contents of applications; general 

information.”

• Agreement limiting access to classified information required by 10 CFR 50.37, 

“Agreement limiting access to Classified Information.”

The staff conducted a docketing acceptance review of SHINE’s partial application and by letter 

dated June 25, 2013 (Reference 10), determined that Part 1 of SHINE’s application for a 

construction permit was complete and acceptable for docketing. The application was assigned

Docket No. 50-608. A notice of docketing Part 1 of SHINE’s application was published in the 

Federal Register on July 1, 2013 (78 FR 39343).

By letter dated May 31, 2013 (Reference 1), SHINE submitted the second and final part of its 

two-part application for a construction permit pursuant to the regulations contained in 

10 CFR Part 50,” which contained the remainder of the preliminary safety analysis report 

(PSAR) required by 10 CFR 50.34(a), “Preliminary safety analysis report.”

While the staff was conducting its acceptance review of Part 2 of SHINE’s application for a 

construction permit, it identified that the SHINE application did not include a discussion of 

preliminary plans for coping with emergencies, as required by 10 CFR 50.34(a)(10). 

Requirements for this plan are set forth in 10 CFR Part 50, Appendix E, “Emergency Planning 

and Preparedness for Production and Utilization Facilities.” Therefore, the NRC staff requested 

that SHINE provide a preliminary plan for coping with emergencies, as required by 10 CFR 

50.34(a)(10), within 30 days of the date of a letter dated August 28, 2013 (Reference 11), 

otherwise the application would be considered incomplete and unacceptable for docketing.

By letter dated September 25, 2013 (Reference 3), SHINE supplemented its construction permit 

application with a discussion of preliminary plans for coping with emergencies, as required by 

10 CFR 50.34(a)(10), completing its application for a construction permit.

By letter dated December 2, 2013 (Reference 12), the NRC staff informed SHINE that Part 2 of 

its construction permit application, as supplemented, contained the remainder of the PSAR 

required by 10 CFR 50.34(a), was submitted in accordance with the requirements of 10 CFR 

2.101(a)(5), and was placed, in its entirety, under Docket No. 50-608. A notice of docketing was 

published in the Federal Register on December 9, 2013 (78 FR 73897).

Areas of Review

The review of SHINE’s construction permit application consisted of two concurrent reviews: 

(1) a safety review of SHINE’s PSAR and (2) an environmental review of SHINE’s 

environmental report. The staff reviewed the SHINE PSAR against applicable regulatory 

requirements using appropriate regulatory guidance and standards, as discussed below, to 

assess the sufficiency of the preliminary design of the SHINE IF and RPF. As part of this 

review, the staff evaluated descriptions and discussions of SHINE’s structures, systems, and 

components (SSCs), with special attention to design and operating characteristics, unusual or 

novel design features, and principal safety considerations. The preliminary design of the SHINE 

IF and RPF was evaluated to ensure the sufficiency of principal design criteria, design bases, 

and information relative to materials of construction, general arrangement, and approximate 

dimensions, sufficient to provide reasonable assurance that the final design will conform to the 

design bases. In addition, the staff reviewed SHINE’s identification and justification for the 

selection of those variables, conditions, or other items that are determined to be probable 
The Facility

1-3

subjects of technical specifications for the facility, with special attention given to those items that 

may significantly influence the final design. The SSCs were also evaluated to ensure that they 

would adequately provide for the prevention of accidents and the mitigation of consequences of 

accidents. The staff considered the preliminary analysis and evaluation of the design and 

performance of the SSCs of the SHINE facility, including those SSCs shared by both the IF and 

RPF, with the objective of assessing the risk to public health and safety resulting from operation 

of the facility.

In accordance with Section 102(2)(A) (42 [United States Code] U.S.C. § 4332(2)(A)) of the 

National Environmental Policy Act, the staff prepared a Final Environmental Impact Statement 

(EIS) based on its independent assessment of the information provided by SHINE and 

information developed independently by the staff. The staff conducted an independent 

evaluation of the application and conducted a systematic, interdisciplinary review of the potential 

impacts of the proposed action on the human environment and reasonable alternatives to 

SHINE’s proposal. Before development of the Draft EIS, the staff issued a notice of intent and 

invited the public to provide information relevant to the environmental review. The staff also 

provided opportunities for governmental and general public participation during the public 

meeting on the Draft EIS and used publicly available guidance in the development of its Final 

EIS. The Final EIS, published as NUREG-2183, meets the requirements of 10 CFR Part 51, 

“Environmental Protection Regulations for Domestic Licensing and Related Regulatory 

Functions.” 

Regulatory Basis and Acceptance Criteria

The staff reviewed the SHINE PSAR against applicable regulatory requirements, using 

appropriate regulatory guidance and standards, to assess the sufficiency of the preliminary 

facility design and analysis for the issuance of a construction permit. In applying guidance and 

acceptance criteria, the staff used its judgment as to which acceptance criteria were relevant to 

SHINE’s proposed facility, as much of this guidance was originally developed for nuclear 

reactors. The staff evaluated the sufficiency of the SHINE preliminary design, as described in 

the PSAR, based on SHINE’s design methodology and ability to provide reasonable assurance 

that the final design will conform to the design bases and allow adequate margin for safety.

In accordance with paragraph (a) of 10 CFR 50.35, “Issuance of construction permits,” a 

construction permit authorizing SHINE to proceed with construction may be issued if the NRC 

makes the following findings:

(1) The applicant has described the proposed design of the facility, including, but not 

limited to, the principal architectural and engineering criteria for the design, and has 

identified the major features or components incorporated therein for the protection of 

the health and safety of the public.

(2) Such further technical or design information as may be required to complete the safety 

analysis, and which can reasonably be left for later consideration, will be supplied in 

the final safety analysis report (FSAR).

(3) Safety features or components, if any, which require research and development have 

been described by the applicant and a research and development program will be 

conducted that is reasonably designed to resolve any safety questions associated with 

such features or components.
The Facility

1-4

(4) On the basis of the foregoing, there is reasonable assurance that: (i) such safety 

questions will be satisfactorily resolved at or before the latest date stated in the 

application for completion of construction of the proposed facility, and (ii) taking into 

consideration the site criteria contained in 10 CFR Part 100, “Reactor Site Criteria,” the 

proposed facility can be constructed and operated at the proposed location without 

undue risk to the health and safety of the public.

With respect to the last of these findings, the staff notes that the requirements of 

10 CFR Part 100 are specific to nuclear power reactors, and therefore not applicable to the 

SHINE facility. However, the staff evaluated SHINE’s site-specific conditions using site criteria 

similar to 10 CFR Part 100, by using the guidance in NUREG-1537. The staff’s review 

evaluated the geography and demography of the site; nearby industrial, transportation, and 

military facilities; site meteorology; site hydrology; and site geology, seismology, and 

geotechnical engineering to ensure that issuance of the construction permit will not be inimical 

to public health and safety. The staff’s review also evaluated structures, systems, components, 

equipment, and systems designed to ensure safe operation, performance, and shutdown when 

subjected to extreme weather, floods, seismic events, missiles (including aircraft impacts), 

chemical and radiological releases, and loss of offsite power.

The construction permit, if issued, would constitute an authorization for SHINE to proceed with 

construction. The staff’s evaluation of the preliminary design and analysis of the SHINE facility 

does not constitute approval of the safety of any design feature or specification. Such approval 

will be made following the evaluation of the final design of the facility, as described in the FSAR 

as part of SHINE’s operating license application.

In addition to the findings listed in 10 CFR 50.35, a construction permit application must also 

provide sufficient information to allow the Commission to make the following determinations in 

accordance with 10 CFR 50.40, “Common standards,” and 50.50, “Issuance of licenses and 

construction permits”:

(1) There is reasonable assurance: (i) that the construction of the facility will not endanger 

the health and safety of the public, and (ii) that construction activities can be 

conducted in compliance with the Commission’s regulations.

(2) The applicant is technically qualified to engage in the construction of its proposed 

facility in accordance with the Commission’s regulations.

(3) The applicant is financially qualified to engage in the construction of its proposed 

facility in accordance with the Commission’s regulations.

(4) The issuance of a permit for the construction of the facility would not be inimical to the 

common defense and security or to the health and safety of the public.

(5) After weighing the environmental, economic, technical and other benefits of the facility 

against environmental and other costs and considering reasonable available 

alternatives, the issuance of this construction permit, subject to the conditions for 

protection of the environment set forth herein, is in accordance with Subpart A of 

10 CFR Part 51 of the Commission’s regulations and all applicable requirements have 

been satisfied.
The Facility

1-5

(6) The application meets the standards and requirements of the Atomic Energy Act and 

the Commission’s regulations, and that notifications, if any, to other agencies or bodies 

have been duly made.

The staff’s evaluation of SHINE’s preliminary design and analysis was based primarily upon the 

following 10 CFR requirements:

• 10 CFR 50.2, “Definitions.”

• 10 CFR 50.22, “Class 103 licenses; for commercial and industrial facilities.”

• 10 CFR 50.33, “Contents of applications; general information,” paragraph (f).

• 10 CFR 50.34, “Contents of applications; technical information,” paragraph (a), 

“Preliminary safety analysis report.”

• 10 CFR 50.35, “Issuance of construction permits.”

• 10 CFR 50.40, “Common standards.”

• 10 CFR 50.55, “Conditions of construction permits, early site permits, combined 

licenses, and manufacturing licenses.”

• 10 CFR 50.58, “Hearings and report of the Advisory Committee on Reactor Safeguards.”

• 10 CFR Part 50, Appendix C, “A Guide for the Financial Data and Related Information 

Required to Establish Financial Qualifications for Construction Permits and Combined 

Licenses.”

• 10 CFR Part 50, Appendix E, “Emergency Planning and Preparedness for Production 

and Utilization Facilities.”

• 10 CFR 20.1201, “Occupational dose limits for adults.”

• 10 CFR 20.1301, “Dose limits for individual members of the public.”

As required by 10 CFR 50.34(a)(3)(i), SHINE must describe the principal design criteria for its 

facility in the PSAR; however, SHINE is not required to follow 10 CFR Part 50, Appendix A, 

“General Design Criteria [GDCs] for Nuclear Power Plants,” which applies only to nuclear power 

reactors. Nonetheless, SHINE has applied the GDCs to the preliminary design of its facility, as 

appropriate. As such, the staff based its review of SHINE’s principal design criteria, in part, on 

SHINE’s application of the following GDCs, as described in Tables 3.5a-1 “Appendix A to 10 

CFR 50 General Design Criteria Which Have Been Interpreted As They Apply to the SHINE 

Irradiation Facility,” and 3.5b-1 “Baseline and General Design Criteria for Radioisotope 

Production Facility,” of the SHINE PSAR.

Given the similarities in SHINE’s proposed facility and non-power research reactors, the staff 

used established guidance documents and the Commission’s regulations to determine the 

acceptance criteria for demonstrating compliance with 10 CFR regulatory requirements. For 

example, the staff used: 
The Facility

1-6

• NUREG-1537, Part 1, “Guidelines for Preparing and Reviewing Applications for the 

Licensing of Non-Power Reactors, Format and Content,” issued February 1996 

(Reference 4).

• 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 (Reference 5).

• “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 (Reference 6).

• “Final Interim Staff Guidance [ISG] 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 (Reference 7). 

• NUREG-0849, “Standard Review Plan for the Review and Evaluation of Emergency 

Plans for Research and Test Reactors,” issued October 1983 (Reference 52). 

As appropriate, the staff used additional guidance (e.g., NRC regulatory guides, Institute of 

Electrical and Electronics Engineers [IEEE] standards, American National Standards 

Institute/American Nuclear Society [ANSI/ANS] standards, and NRC office instructions) in the 

review of SHINE’s PSAR. The additional guidance was used based on the technical judgment

of the reviewer, as well as references in NUREG-1537, Parts 1 and 2; the ISG Augmenting 

NUREG-1537, Parts 1 and 2; and the SHINE PSAR.

Review Procedures

The staff’s review was tailored to the nature of SHINE’s application and was informed by the 

staff’s ISG Augmenting NUREG-1537, NUREG-1537, as well as other relevant guidance cited 

therein, cited in the application, or used based on the staff’s technical judgment. In particular, 

SHINE’s 10 CFR Part 50 construction permit application only seeks authorization to construct 

the proposed SHINE facility. Therefore, the level of detail needed in the application and the 

staff’s corresponding SER is different than for a combined operating license or an operating 

license. For the purposes of issuing a construction permit, the SHINE facility may be 

adequately described at a functional or conceptual level in the PSAR. As such, SHINE has 

deferred providing many design and analysis details until the submission of its FSAR with its 

operating license application. 

The objective of the staff’s evaluation was to assess the sufficiency of information contained in 

the PSAR for the issuance of a construction permit, in accordance with 10 CFR 50.35(a) and 

10 CFR 50.40. An in-depth evaluation of the SHINE design will be performed following the 

staff’s receipt of SHINE’s FSAR.

The staff’s safety review was also tailored to the unique and novel technology described in 

SHINE’s construction permit application. SHINE proposes to construct an IF and a RPF housed 

within a single building. The proposed IF consists of eight subcritical operating assemblies, 

each of which would be licensed as a utilization facility as defined in 10 CFR 50.2. The 
The Facility

1-7

proposed RPF consists of three “supercells” for the separation of molybdenum-99 (Mo-99) from 

irradiated target solution, plus hot-cell and glove-box structures for processing of irradiated and 

un-irradiated low-enriched uranium (LEU) materials, licensed collectively as a production facility, 

as defined in 10 CFR 50.2. 

Resolving Technical Issues

For those technical areas that require additional information supported by research and 

development (i.e., a maturation of facility design), the staff has several options: 

(1) The staff may determine that such technical issues must be resolved prior to the 

issuance of a construction permit.

(2) The staff may determine that such information may be left until the submission of the 

FSAR.

(3) The staff may require that such technical issues be resolved prior to the completion of 

construction, but after the issuance of the construction permit.

Technical issues that fall within the scope of the first option require additional information be 

provided in order to establish principal design criteria and/or design bases so that the staff may 

have confidence that the final facility design will conform to the design basis. The staff resolves 

such technical issues through requests for additional information (RAIs).

In the second and third options, the staff may also issue RAIs to resolve identified technical 

issues. These types of technical issues are those that require a design maturity beyond what is 

required by 10 CFR 50.34(a) to issue a construction permit. Although determining what 

constitutes a preliminary versus a final design may be somewhat subjective, according to 

10 CFR 50.34, a preliminary design must only include principal design criteria, the design 

bases, general facility arrangement, and approximate dimensions. This information should be 

sufficient to provide reasonable assurance that the final design will conform to the design bases 

with adequate margin for safety. The staff may issue RAIs if it determines that it is necessary 

for the applicant to acknowledge certain technical deficiencies that could impact final design.

Appropriate responses to these RAIs include commitments to resolving these deficiencies either 

in the FSAR or before the completion of construction.

During its review of the SHINE construction permit application, the NRC staff determined that 

additional information was required to complete the review of SHINE’s PSAR and for the staff to 

prepare this SER. Therefore, the staff prepared and issued RAIs dated September 19, 2014, 

January 6, 2015, March 25, 2015, April 15, 2015, and September 24, 2015 (Reference 14, 

Reference 15, Reference 16, Reference 17, and Reference 18, respectively). 

As of September 2015, SHINE acceptably responded to all staff RAIs for developing an SER.

However, the staff has determined that additional information is needed to address certain 

matters related to nuclear criticality safety and radiation protection in the RPF. Appendix A, 

“Permit Conditions and Regulatory Commitments,” to this SER identifies permit conditions that 

the staff recommends be included in a construction permit, if issued to SHINE. The conditions 

are confirmatory in nature and must be satisfied prior to the completion of construction. 

Additional details on the basis and timing of satisfaction for each condition appear in the 

technical evaluations of the SHINE construction permit SER, Chapters 6, “Engineered Safety 

Features,” and 11, “Radiation Protection Program and Waste Management.” 
The Facility

1-8

Additionally, SER Appendix A contains a listing of those elements of design, analysis, and 

administration identified as requiring additional research and development or correction by the 

applicant through its Issues Management Report System. The staff determined that resolution 

of these items is not necessary for the issuance of a construction permit, but the applicant 

should ensure that these items are fully addressed in the FSAR supporting the issuance of an 

operating license. The staff is tracking these items as regulatory commitments and will verify 

their implementation during the review of a SHINE operating license application.

Ongoing Research and Development

The provisions of 10 CFR 50.34(a)(8) allow for ongoing research and development to confirm 

the adequacy of the design of structures, systems, and components to resolve safety questions 

prior to the completion of construction. In accordance with 10 CFR 50.34(a)(8), and as 

described in SHINE PSAR Section 1.3.9, “Research and Development,” and in response to 

RAI G-1, SHINE has identified two ongoing research and development activities: 

(1) Irradiation and corrosion testing at Oak Ridge National Laboratory to study mechanical 

performance of materials, as described in the PSAR.

(2) Precipitation studies at Argonne National Laboratory to ensure precipitation of uranyl 

peroxide in the target solution will not occur, as described in response to RAI G-1.

In support of these activities, SHINE has provided descriptions of affected SSCs, the 

remaining work to be performed, and anticipated schedules for completion. By letter dated 

September 29, 2015 (Reference 104), SHINE has stated that the latest date for completion of 

construction is expected to be December 31, 2022. Based on the schedules provided in 

response to RAI G-1, SHINE’s two research and development activities would be resolved in 

advance of the estimated completion of construction. As described in Appendix A to this SER, 

the staff is tracking these activities and will verify their resolution prior to the completion of 

construction.

Advisory Committee on Reactor Safeguards Review

To support the Advisory Committee on Reactor Safeguards (ACRS) in providing an independent 

review and report to the Commission regarding the SHINE construction permit application, the 

staff presented the results of its safety evaluation to the Radiation Protection and Nuclear 

Materials Subcommittee at four meetings on: June 23, 2015, June 24, 2015, August 19, 2015, 

and September 22, 2015. The staff presented the results of its SHINE construction permit 

application review to the ACRS Full Committee on October 8, 2015. The ACRS issued a letter 

on October 15, 2015, which has been included as Appendix D, “Report by the Advisory 

Committee on Reactor Safeguards,” of this SER, fulfilling the requirement of 10 CFR 50.58, 

“Hearings and report of the Advisory Committee on Reactor Safeguards,” that the ACRS review 

and report on construction permits for a facility of the type described in 10 CFR 50.22, 

“Class 103 licenses; for commercial and industrial facilities.”

The ACRS letter to the Commission recommended that the SHINE construction permit should 

be approved. The ACRS identified two safety concerns that could impact the operation of the 

SHINE facility, if not sufficiently addressed during construction. To address these concerns, the 

ACRS requested and SHINE and the staff provided additional information on (1) the facility’s 

layup capability, and (2) the facility’s ability to withstand potential aircraft impact. The ACRS 
The Facility

1-9

noted that, “nuclear chemical processing facilities need to have built-in capability to support 

layup following unexpected process interruptions. It must be possible to stop the process, 

safely remove materials within the system, clean the system, and place it in a safe condition for 

an extended period in a way that does not challenge the facility piping systems and chemical 

reactors.” During the ACRS subcommittee and full committee meetings, SHINE and the NRC 

staff: (1) provided information addressing the provisions made to address facility layup, and 

(2) clarified the analysis of the SHINE facility’s ability to withstand aircraft impacts. Based on 

discussions during the subcommittee and full committee meetings, the ACRS determined that 

SHINE and the NRC staff provided sufficient information to address facility layup and potential 

aircraft impact, such that it could recommend the issuance of a construction permit. 

Additionally, SHINE clarified the relationship between safety-related SSCs and safety-related 

activities, by defining safety-related activities. SHINE has committed to providing procedures for 

facility layup and an updated quality assurance program description that includes its definition of 

safety-related activities in its FSAR (References 102 and 103). The staff is tracking these 

commitments in Appendix A of this SER. 

Application Availability

Publicly-available documents related to the SHINE construction permit application may be 

obtained online in the ADAMS Public Documents collection at http://www.nrc.gov/readingrm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin 

Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC’s Public 

Document Room (PDR) reference staff at 1-800-397-4209, at 301-415-4737, or by e-mail to 

pdr.resource@nrc.gov. 

The current version of SHINE’s PSAR, submitted August 27, 2015, is publicly available in 

ADAMS, under Accession No. ML15258A431 (Reference 19). Other public documents and 

correspondence related to this application may be found by searching SHINE’s Docket Number, 

50-608, or project number PROJ0792 in ADAMS. Portions of the application or correspondence 

containing sensitive information (e.g., proprietary information) are being withheld form public 

disclosure pursuant to 10 CFR 2.390, “Public inspections, exemptions, requests for 

withholding.”

NRC Staff Contact Information

The project manager for this SER was Steven Lynch, Project Manager, Division of Policy and 

Rulemaking, U.S. Nuclear Regulatory Commission. Mr. Lynch may be contacted regarding this 

SER by telephone at 301-415-1524 or e-mail at Steven.Lynch@nrc.gov. Appendix C, “Principal 

Contributors,” to this SER provides a listing of principal contributors, including areas of technical 

expertise and chapters of authorship.

Summary and Conclusions on Principal Safety Considerations

The staff evaluated descriptions and discussions of the IF and RPF, including probable subjects 

of technical specifications, as described in the SHINE PSAR and supplemented by the 

applicant’s responses to RAIs. On the basis of its review, makes the following findings:

(1) Applicable standards and requirements of the Atomic Energy Act and Commission 

regulations have been met.
The Facility

1-10

(2) Acceptance criteria in or referenced in NUREG-1537 or the ISG Augmenting 

NUREG-1537 have been satisfied.

(3) Required notifications to other agencies or bodies related to this licensing action have 

been duly made. 

(4) The design of the facility includes adequate margins of safety and there is reasonable 

assurance that the final design will conform to the design basis.

(5) There is reasonable assurance that the facility can be constructed in conformity with 

the permit, the provisions of the Atomic Energy Act, and the Commission’s regulations.

(6) SHINE has considered the expected consequences of several postulated accidents. 

The staff has performed conservative analyses of the most serious, hypothetically 

credible and non-credible accidents and determined that the calculated potential 

radiation doses outside the facility site are not likely to exceed the guidelines of 

10 CFR Part 20, “Standards for Protection Against Radiation.” Furthermore, SSCs 

have been designed to provide for the prevention of accidents and the mitigation of 

consequences of accidents.

(7) Releases of radioactive materials and wastes from the facility are not expected to 

result in concentrations outside the limits specified by 10 CFR Part 20, Subpart D, 

Radiation Dose Limits for Individual Members of the Public,” and are as low as is 

reasonably achievable (ALARA).

(8) The financial data demonstrate that SHINE is qualified to engage in the construction of 

its proposed facility in accordance with the Commission’s regulations.

(9) The preliminary emergency plan provides reasonable assurance that SHINE will be 

prepared to assess and respond to emergency events.

(10) The application presents information at a level of detail that is appropriate for general 

familiarization and understanding of the proposed facility.

(11) The application describes the relationship of specific facility design features to the 

major processes that will be ongoing at the facility. This description includes the 

building locations of major process components; drawings illustrating the layout of the 

buildings and structures within the controlled area boundary are used for the 

description.

(12) The application describes the major chemical or mechanical processes involving 

licensable quantities of radioactive material based, in part, on integrated safety 

analysis (ISA) methodology. This description includes the building locations of major 

process components and brief accounts of the process steps.

(13) Issuance of the construction permit will not be inimical to the common defense and 

security or to the health and safety of the public.

Therefore, the staff finds that the preliminary design and analysis of the SHINE IF and RPF, as 

described in the SHINE PSAR, is sufficient and meets the applicable regulatory requirements 

and guidance for the issuance of a construction permit in accordance with 10 CFR 50.35. 
The Facility

1-11

Further technical or design information required to complete the safety analysis may reasonably 

be left for later consideration. Appendix A to this SER identifies certain permit conditions that 

the staff recommends the Commission include, if the construction permit is issued. Additionally, 

Appendix A contains a listing of those elements of design, analysis, and administration identified 

as requiring additional research and development or correction by the applicant through its 

Issues Management Report System. The staff has determined that while resolution of these 

items is not necessary for the issuance of a construction permit, it is the responsibility of the 

applicant to ensure that these items have been full addressed in the FSAR supporting the 

issuance of an operating license. The staff is tracking these items as regulatory commitments 

and will verify their implementation during the review of SHINE’s operating license application.

However, the staff has determined that additional information is needed to address certain 

matters related to nuclear criticality safety and radiation protection in the RPF. Accordingly, the 

staff is proposing that the construction permit be conditioned upon SHINE providing information 

related to nuclear criticality safety and radiation protection, as described in Appendix A of this 

SER. The proposed conditions of the construction permit are confirmatory in nature and must 

be satisfied prior to the completion of construction. Additional details on the basis for each 

condition appear in the technical evaluations SER Chapters 6, “Engineered Safety Features,” 

and 11, “Radiation Protection Program and Waste Management.” 

On the basis of these findings as documented in this SER, the staff recommends that the 

Commission make the following conclusions for the issuance of a construction permit in 

accordance with 10 CFR 50.35, 50.40, and 50.50:

(1) SHINE has described the proposed design of the facility, including, but not limited to, 

the principal architectural and engineering criteria for the design, and has identified the 

major features or components incorporated therein for the protection of the health and 

safety of the public.

(2) Further technical or design information required to complete the safety analysis, which 

can reasonably be left for later consideration, will be supplied in the FSAR.

(3) Safety features or components that require research and development have been 

described by SHINE and a research and development program will be conducted that 

is reasonably designed to resolve any safety questions associated with such features 

or components. 

(4) On the basis of the foregoing, there is reasonable assurance that: (i) such safety 

questions will be satisfactorily resolved at or before the latest date stated in the 

application for completion of construction of the proposed facility, and (ii) taking into 

consideration the site criteria contained in 10 CFR Part 100, the proposed facility can 

be constructed and operated at the proposed location without undue risk to the health 

and safety of the public.

(5) There is reasonable assurance: (i) that the construction of the SHINE facility will not 

endanger the health and safety of the public, and (ii) that construction activities can be 

conducted in compliance with the Commission’s regulations.

(6) SHINE is technically qualified to engage in the construction of its proposed facility in 

accordance with the Commission’s regulations.
The Facility

1-12

(7) SHINE is financially qualified to engage in the construction of its proposed facility in 

accordance with the Commission’s regulations.

(8) The issuance of a permit for the construction of the facility would not be inimical to the 

common defense and security or to the health and safety of the public.

(9) After weighing the environmental, economic, technical and other benefits of the facility 

against environmental and other costs and considering reasonable available 

alternatives, the issuance of this construction permit, subject to the conditions for 

protection of the environment set forth herein, is in accordance with Subpart A, 

“National Environmental Policy Act—Regulations Implementing Section 102(2),” of 

10 CFR Part 51 of the Commission’s regulations and all applicable requirements have 

been satisfied.

(10) The application meets the standards and requirements of the Atomic Energy Act and 

the Commission’s regulations, and that notifications to other agencies or bodies have 

been duly made.

General Description

The staff evaluated the sufficiency of the general description of the SHINE facility, as presented 

in SHINE PSAR Section 1.3, “General Description of the Facility,” in part, by reviewing the 

geographical location of the facility; principal characteristics of the site; principal design criteria, 

operating characteristics, and safety systems; thermal power level; engineered safety features; 

instrumentation control, and electrical systems; coolant and other auxiliary systems; radioactive 

waste management provisions; radiation protection; the general arrangement of major 

structures and equipment; safety features of special interest; and novel facility design 

considerations using the guidance and acceptance criteria from Section 1.3, “General 

Description,” of NUREG-1537, Parts 1 and 2.

SHINE identifies itself as a Wisconsin corporation, a private organization that was created for 

the purpose of designing, constructing, and operating a medical radioisotope production facility 

which will be located on previously undeveloped agricultural property in Rock County, 

Wisconsin, approximately 1 mile south of the corporate boundaries the City of Janesville. 

SHINE developed a new method for producing Mo-99 using accelerator-driven neutron sources 

to induce fission in LEU within a subcritical operating assembly, creating Mo-99 as a byproduct.

The SHINE medical radioisotope production facility consists of an IF and RPF. The IF would 

consist of eight subcritical operating assemblies (or IUs), which would each be licensed as 

utilization facilities as defined in 10 CFR Section 50.2. The RPF would consist of three hot cell 

structures, licensed collectively as a production facility, as defined in 10 CFR 50.2.

The IUs operate as subcritical operating assemblies in a batch mode with an approximate 

week-long operating cycle. Each IU consists of a neutron driver assembly, a subcritical 

assembly system, a light water pool system, a target solution vessel (TSV) off-gas system, and 

other supporting systems. The RPF also operates in a batch mode, and consists of the 

following processes dedicated to the extraction, purification, and packaging of Mo-99 for the end 

users, as well as preparing the target solution for the IU:

• Target solution preparation system (TSPS).

• Molybdenum extraction and purification system (MEPS).
The Facility

1-13

• Uranyl nitrate conversion system (UNCS).

• Noble gas removal system (NGRS).

• Process vessel vent system (PVVS).

• Radioactive liquid waste evaporation and immobilization (RLWE).

• Aqueous radioactive liquid waste storage (RLWS).

• Organic liquid waste storage and export (OLWS).

• Molybdenum isotope product packaging system (MIPS).

• Radioactive drain system (RDS).

In order to produce Mo-99, first, the uranyl sulfate solution is prepared from recycled materials 

and/or from raw feed materials in the RPF. The target solution is then transferred to the TSVs 

within the IF. Once the target solution is in the TSV, the subcritical assembly is operated at full 

power for approximately 5.5 days, at which time the IU is shut down and the irradiated target 

solution is transferred to the RPF for radioisotope extraction. Following initial extraction, the 

Mo-99 is purified and packaged for shipment to customers. The remaining target solution is 

then prepared for further irradiation in the IUs.

As described in greater detail in subsequent chapters, the design of the SHINE facility includes 

engineered safety features to mitigate design basis events or accidents; control and protection 

systems; a Class 1E uninterruptable electrical power supply; primary cooling; ventilation; 

equipment and processes related to handling and storage of target solution, byproduct material, 

and special nuclear material (SNM); a tritium purification system; and fire protection systems.

SHINE has a radioactive waste management program and a radiation protection program.

Shared Facilities and Equipment

The staff evaluated the sufficiency of the evaluation of shared facilities and equipment, as 

presented in SHINE PSAR Section 1.4, “Shared Facilities and Equipment,” using the guidance 

and acceptance criteria from Section 1.4, “Shared Facilities and Equipment,” of NUREG-1537, 

Parts 1 and 2. The acceptance criteria state that comparisons should show that the proposed 

facility would not exceed the safety envelope of similar facilities and that there should be 

reasonable assurance that radiological exposures of the public would not exceed the 

regulations and guidelines of the facility ALARA program.

Consistent with the review procedures of NUREG-1537, Part 2, Section 1.4, the staff confirmed 

that all facilities or equipment shared by the SHINE facility are discussed in the PSAR.

As stated, in part, in SHINE’s PSAR Section 1.4, “[t]he SHINE facility does not share any 

systems or equipment with facilities not covered by this report.” However, the SHINE facility 

building includes both the IF and RPF, which, while functionally separate, share some common 

systems.

The NRC staff finds that all facilities or equipment that will be shared by the SHINE facility

represent new construction on previously undeveloped agricultural property. The interface 

between the IF and RPF, including common systems shared between these facilities, has been 

adequately analyzed in other chapters in the PSAR.

On the basis of its review, the staff has determined that the level of detail provided on shared 

facilities and equipment satisfies the applicable acceptance criteria of NUREG-1537, Part 2, 

Section 1.4, allowing the staff to make the following relevant findings:
The Facility

1-14

(1) There are no facilities, systems, or equipment shared by the SHINE facility that are not 

covered in the SHINE PSAR. 

(2) While the SHINE IF and RPF share a common building and several common systems

(e.g., cooling and electrical systems), the applicant has shown that a malfunction or a 

loss of function of either of these facilities would not affect the operation of the other. 

Neither facility would be damaged as a result of a malfunction or a loss of function of 

the other and both facilities would maintain the capability to be safely shut down or

maintained in a safe condition.

(3) Neither normal operation nor a loss of function of the IF or RPF would lead to 

uncontrolled release of radioactive material from the licensed facility to unrestricted 

areas, or in the event of release, the exposures are analyzed in SER Chapter 13, 

“Accident Analyses,” and are found to be acceptable.

Therefore, the staff finds that the evaluation of shared facilities and equipment, as described in 

SHINE PSAR Section 1.4, is sufficient and meets the applicable regulatory requirements and 

guidance for the issuance of a construction permit in accordance with 10 CFR 50.35. 

Comparison with Similar Facilities

The staff evaluated the sufficiency of the comparison of the SHINE facility with other similar 

facilities, as presented in SHINE PSAR Section 1.5, “Comparison with Similar Facilities,” using 

the guidance and acceptance criteria from Section 1.5, “Comparison with Similar Facilities,” of 

NUREG-1537, Parts 1 and 2.

Consistent with the review procedures of NUREG-1537, Part 2, Section 1.5, the staff confirmed 

that the characteristics of any facilities compared with the proposed facility were similar and 

relevant. The staff also verified that the operating history of licensed facilities cited by the 

applicant demonstrated consistently safe operation, use, and protection of the public.

As stated, in part, in SHINE PSAR Section 1.5.1, “Comparison of Physical Plant Equipment,” 

“the SHINE facility uses new technology for the manufacture of medical radioisotopes. The IU, 

consisting of the neutron driver, subcritical assembly, light water pool, TOGS [target solution 

vessel off-gas system], and other supporting systems represent the new technology. As such, 

there are no similar facilities that compare to the IUs.”

The premise of the SHINE technology is that the IUs will not be operated such that the effective 

neutron multiplication factor (keff) is greater than or equal to 1.0, a range for which nuclear 

reactors are designed, analyzed, and licensed to operate safely. Instead, the IUs will only 

operate in a minimally subcritical range of keff. To operate safely within this margin of 

subcriticality, the IUs are designed with several features of a nuclear reactor except that, by 

design, the TSVs have insufficient reactivity to sustain a chain reaction.

While the NRC staff concludes that the IUs represent new technology, the accelerator and 

neutron multiplier add sufficient external neutrons to the TSV to achieve a fission rate with a 

thermal power level comparable to non-power reactors typically licensed under 10 CFR Part 50 
The Facility

1-15

as utilization facilities.1

 Given this fission power, the IUs also have many safety considerations 

similar to those of non-power reactors, including the following:

• Provisions for removal of fission heat during operation.

• Consideration of decay heat generation after shutdown.

• Reactivity feedback mechanisms similar to non-power reactors.

• Control of fission gas release during operation and subsequent gas management 

engineering safety features.

• Control of radiolytic decomposition of water and generated oxygen and hydrogen gases.

• Control of fission product inventory buildup. 

• Accident scenarios similar to non-power reactors, such as loss of coolant, reactivity 

additions, and release of fission products.

As such, given that SHINE’s proposed IUs closely resemble non-power reactors, which are 

licensed as utilization facilities under 10 CFR Part 50, the NRC staff determined that it would be 

most appropriate to license SHINE’s IUs as utilization facilities under 10 CFR Part 50. 

However, at the time of SHINE’s initial application submission, the IUs could not be licensed as 

utilization facilities because they are not nuclear reactors. Therefore, while 10 CFR Part 50 

would have been appropriate to apply from a technical and licensing review process standpoint, 

the IUs could not be licensed as utilization facilities under the current regulations. 

The NRC staff also considered whether it should review SHINE’s IUs under 10 CFR Part 70, 

“Domestic Licensing of Special Nuclear Material,” which regulates the issuance of licenses to 

receive title to, own, acquire, deliver, receive, possess, use, and transfer special nuclear 

material (SNM). From a regulatory perspective, 10 CFR Part 70 could have been applied 

because SHINE will acquire, receive, possess, use, and transfer SNM. The requirements of 

10 CFR Part 70, Subpart H, “Additional Requirements for Certain Licensees Authorized to 

Possess a Critical Mass of Special Nuclear Material,” could also be applied because SHINE will 

possess a critical mass of SNM, and will engage in an activity that could significantly affect 

public health and safety.

However, the facilities conducting the types of activities typically regulated under 

10 CFR Part 70, generally referred to as fuel cycle facilities, have a common objective of 

avoiding criticality by maintaining a significant margin from criticality under normal operating and 

accident conditions. Specifically, 10 CFR 70.61(d) calls for “... use of an approved margin of 

subcriticality for safety.” SHINE’s IUs have a proposed routine operating margin of subcriticality 

of less than what has been previously approved for other 10 CFR Part 70 licensees. This 

operating state more closely resembles the effective neutron multiplication factor of nuclear 

 1 Non-power reactors currently licensed to operate by the NRC range in thermal power from 5 watts to 

20 megawatts. In the past, the NRC has licensed 12 aqueous homogeneous reactors (AHRs) with thermal power 

levels ranging from 5 watts to 50 kilowatts. An AHR is similar to the SHINE target solution vessel in that both contain 

fissile material in an aqueous solution; the difference is that the target solution vessel has insufficient fissile material 

for a sustained chain reaction.
The Facility

1-16

reactors than fuel cycle facilities. Because SHINE proposes to operate each IU in a manner 

similar to a nuclear reactor, the NRC staff determined that it would be most appropriate to use 

the regulations contained in 10 CFR Part 50 to perform its technical review of the IUs.

Therefore, on October 17, 2014 (79 FR 62329), the NRC issued a direct final rule, which 

became effective December 31, 2014, amending the definition of utilization facility in 

10 CFR 50.2 to include SHINE’s IUs, so that they could be licensed under 10 CFR Part 50: 

Utilization facility means:

(1) Any nuclear reactor other than one designed or used primarily for the formation 

of plutonium or uranium-233 (U–233); or

(2) An accelerator-driven subcritical operating assembly used for the irradiation of 

materials containing special nuclear material and described in the application 

assigned Docket Number 50–608.

The rulemaking allowed the NRC staff to conduct its licensing review of the proposed SHINE 

IUs following regulations designed for technologies with similar radiological, health, and safety 

considerations. Additionally, the rule does not affect the ability of the public to comment and 

request a hearing on the application; and the inclusion of SHINE’s Docket Number as well as a 

description of the SHINE’s IU technology limits the applicability of the rule to SHINE’s proposed 

IUs, ensuring no impact to other existing or future facilities. If, in the future, any applicant 

proposes a technology similar to SHINE’s IUs2

, the Commission would consider that application 

on a case-by-case basis, and assign a distinct Docket Number to each application. Should 

SHINE propose a technology other than the IUs currently described in its PSAR, the rule would 

no longer apply to SHINE, and the NRC staff would pursue an alternative licensing approach.

The SHINE RPF consists of hot cells used to process irradiated target solution for Mo-99 

separation and purification. According to the SHINE PSAR Section 1.5.1, “[t]he hot cell design 

is conventional and is similar to the design used in many other facilities.” The primary chemical 

processes occurring in the hot cells are molybdenum extraction, molybdenum purification, 

uranyl nitrate conversion, uranium extraction, evaporation and thermal denitration, waste 

evaporation and solidification, and tritium purification.”

Regarding molybdenum extraction, there are currently no NRC or U.S. Department of Energy 

(DOE) facilities that use SHINE’s specific process. However, SHINE cites the Site Ion 

Exchange Effluent Plant (SIXEP) in the United Kingdom, which uses clinoptilolite to remove 

cesium and strontium from aqueous process streams, as an example of a facility performing a 

similar process to SHINE’s proposed molybdenum extraction.

According to a paper prepared by Aker Kvaerner Engineering Services, entitled, “Radio Active 

Waste Plants – Back to the Future,” SIXEP has been in operation since 1985 and, “represents 

an early generation of Radwaste plant for the treatment of site magnox sourced liquid effluents,

designed in the late 1970’s, and based on the use of filtration and ion exchange.”

With respect to the molybdenum purification process, SHINE states that its process is similar to 

the Cintichem process developed in the 1950s and 1960s by Union Carbide. Cintichem, 

 2 At this time, the NRC staff does not anticipate receiving any other applications for medical radioisotope production 

facilities that would propose a technology similar to SHINE’s IUs.
The Facility

1-17

licensed by the NRC, operated until 1990 as means to purify Mo-99 for used as a medical 

radioisotope. The primary difference between SHINE’s molybdenum purification process and 

that of Cintichem is a slight change in process chemistry to accommodate the change in 

chemical and isotopic composition due to the switch from highly-enriched uranium to LEU. 

Similar to Cintichem, shielding and confinement will serve as the principal engineered safety 

features designed to reduce worker doses associated with this activity at the SHINE facility.

As stated, in part, in SHINE PSAR Section 1.5.2.3, “Uranyl Nitrate Conversion,” “[t]he 

conversion of uranyl sulfate to uranyl nitrate is necessary to enable fission products to be 

removed from the uranium, in order to recycle the uranium within the target solution loop. The 

conversion step for the uranyl sulfate is not currently used in any NRC or DOE facilities.” 

However, the NRC staff notes that Argonne National Laboratory is conducting research for the 

SHINE project on the conversion of uranyl sulfate solution to uranyl nitrate solution for 

processing in uranium extraction (UREX), as presented at the Mo-99 Topical Meeting, hosted 

by Argonne National Laboratory in Washington, DC from June 24 through 27, 2014.

The SHINE UREX process is a modification of a widely-used uranium and plutonium separation 

and purification process known as plutonium and uranium extraction (PUREX). The PUREX 

process was developed in the late 1940s and uses tributyl phosphate (TBP) to selectively 

remove uranium and plutonium from a nitric acid solution typically containing a host of fission 

product and other actinide contaminants. SHINE lists the principal locations that either currently 

or have historically used the PUREX process:

a. Hanford, Washington

b. Savannah River Site, South Carolina

c. Idaho National Laboratory, Idaho

d. West Valley, New York

e. Radiochemical Engineering Development Center, Oak Ridge National Laboratory, 

Tennessee

f. Sellafield, United Kingdom

g. Mayak, Russia

h. AREVA La Hague site, France

i. Rokkasho, Japan

The staff notes that the PUREX process has traditionally been employed by fuel reprocessing 

facilities (i.e., Hanford, Savanna River and West Valley), in which irradiated fuel goes through 

dissolution, fission product and waste separation, and uranyl and plutonium nitrate purification.

Despite similarities in process, the staff does not consider the SHINE RPF a fuel reprocessing 

facility. While the SHINE UREX process is similar to these facilities, unlike the traditional fuel 

reprocessing facilities, the UREX process used by SHINE will not be separating plutonium from 

its irradiated target solution.

There is currently neither a statutory nor regulatory definition for what does and does not 

constitute a fuel reprocessing facility. While fuel reprocessing plants are considered production 

facilities under 10 CFR Part 50, more specific definitions and interpretations of fuel reprocessing 

facilities have varied over the years, as evidenced in Federal Register Notices, staff-generated 

SECY Papers, and Nuclear Energy Institute white papers (see: 

http://www.nrc.gov/materials/reprocessing.html, “Additional Documents,” and 39 FR 26293).

In 2006, the Commission directed the Advisory Committee on Nuclear Waste and Materials (the 

Committee) to become knowledgeable in the area of spent nuclear fuel reprocessing and define 

the issues most important to the NRC concerning fuel reprocessing facilities. As a result, the 
The Facility

1-18

Committee published a white paper, NUREG-1909, “Background, Status, and Issues Related to 

the Regulation of Spent Nuclear Fuel Recycle Facilities,” in June 2008, representing the only 

current regulatory guidance on this issue. In this white paper, the Committee describes 

“reprocessing” as the separation of spent nuclear fuel into its constituent components (pages xv 

and 152) 3

.

As defined in 10 CFR 72.3, “Definitions,” spent nuclear fuel or spent fuel means “fuel that has 

been withdrawn from a nuclear reactor following irradiation, has undergone at least one year’s 

decay since being used as a source of energy in a power reactor, and has not been chemically 

separated into is constituent elements by reprocessing...”

Based on the definitions of spent nuclear fuel and reprocessing discussed above, it can be 

inferred that only fuel from a nuclear power reactor is considered spent nuclear fuel, and 

therefore, only fuel from a nuclear power reactor may undergo reprocessing. Since the SHINE

RPF will only process the LEU target solution previously irradiated in the IF and will not be 

processing spent nuclear fuel, as defined in 10 CFR 72.3, the staff has concluded that the 

processing of SHINE’s irradiated LEU target solution does not constitute fuel reprocessing. 

Therefore, the SHINE production facility is not a fuel reprocessing facility.

Regarding evaporation and thermal denitration, while there are no NRC-licensed uranyl nitrate 

evaporation and denitration facilities in operation, SHINE has identified fluidized bed thermal 

denitration performed at the previously identified PUREX facilities as a similar process.

SHINE cites the DOE Hanford site with submerged tube forced recirculation evaporator 

operational experience, as used at the SHINE facility. Construction of the Hanford site was 

completed in 1977, and the evaporator is anticipated to operate into at least the 2040s.

SHINE likens its tritium purification system with similar processes conducted at the Savannah 

River Site and Laboratory for Laser Energetics. However, in PSAR Section 1.5.2.7, “Tritium 

Purification System,” SHINE states, in part, that “[d]ue to the sensitive and confidential nature of 

information relating to tritium production and purification, the design and operational details of 

these systems are not published. A comparison of the SHINE system with existing facilities is 

therefore not possible.”

On the basis of its review, the staff has determined that the level of detail provided on 

comparisons with similar facilities satisfies the applicable acceptance criteria of NUREG-1537, 

Part 2, Section 1.5, allowing the staff to make the following findings:

(1) SHINE has compared the design bases and safety considerations with similar 

facilities, as practicable. The history of these facilities demonstrates consistently safe 

operation that is acceptable to the staff.

(2) Aspects of SHINE’s design that are similar to features in other facilities that have been 

found acceptable to the staff, should be expected to perform in a similar manner when 

constructed to that design.

 3 This definition is also generally consistent with the description of reprocessing on the NRC’s public webpage: 

“Reprocessing refers generally to the processes necessary to separate spent nuclear reactor fuel into material that 

may be recycled for use in new fuel and material that would be discarded as waste.” 

(http://www.nrc.gov/materials/reprocessing.html). 
The Facility

1-19

(3) SHINE is using test data and operational experience in designing components and

SHINE cited the actual facilities with similar components, as practicable.

Therefore, the staff concludes that the comparisons with similar facilities, as described in SHINE 

PSAR Section 1.5 is sufficient and meets the applicable regulatory requirements and guidance 

for the issuance of a construction permit consistent with 10 CFR 50.35.

Summary of Operations

The staff evaluated the sufficiency of the comparison of the SHINE Summary of Operations, as 

presented in SHINE PSAR Section 1.6, “Summary of Operations,” using the guidance and 

acceptance criteria from Section 1.6, “Summary of Operations,” of NUREG-1537, Parts 1 and 2.

Consistent with the review procedures of NUREG-1537, Part 2, Section 1.6, the staff verified 

that proposed operations of the SHINE facility had been summarized.

The SHINE facility is capable of producing up to 8200 6-day curies of Mo-99 per week. SHINE 

listed the major operations to be performed in the SHINE facility for this Mo-99 production as 

follows:

• Target solution preparation from raw feed material (uranium metal).

• Target solution preparation from irradiated and processed target solution.

• Irradiation of target solution.

• Mo extraction from irradiated target solution.

• Mo purification.

• Target solution processing (cleanup).

As described above in SER Section 1.3, “General Description,” the uranyl sulfate solution is 

prepared from recycled materials and/or from raw feed materials in the RPF. The target 

solution is then transferred to the TSVs within the IF. Once the target solution is in the TSV, the 

subcritical assembly is operated at full power for approximately 5.5 days, at which time the IU is 

shut down and the irradiated target solution is transferred to the RPF for radioisotope extraction. 

Following initial extraction, the Mo-99 is purified and packaged for shipment to customers. The 

remaining target solution is then prepared for further irradiation in the IUs. 

On the basis of its review, the staff has determined that the level of detail provided on 

comparisons with similar facilities satisfies the applicable acceptance criteria of NUREG-1537, 

Part 2, Section 1.6. The staff also finds that the proposed operating conditions and schedules 

are consistent with the design features of the facility and have been found acceptable to the 

staff. The proposed operations are consistent with the relevant assumptions in later chapters of 

the PSAR, in which any safety implications of the proposed operations are evaluated.

Therefore, the staff concludes that the summary of operations, as described in SHINE PSAR 

Section 1.6 is sufficient and meets the applicable regulatory requirements and guidance for the 

issuance of a construction permit in accordance with 10 CFR 50.35. Further technical or design 

information required to complete the safety analysis may reasonably be left for later 

consideration.
The Facility

1-20

Compliance with the Nuclear Waste Policy Act of 1982

The Nuclear Waste Policy Act provides that the U.S. government is responsible for the 

permanent disposal of high-level radioactive waste and spent nuclear fuel, but the cost of 

disposal should be the responsibility of the generators and owners of such waste and spent fuel. 

The staff evaluated the sufficiency of SHINE’s compliance with the Nuclear Waste Policy Act of 

1982 (Reference 33), as presented in SHINE PSAR Section 1.7, “Compliance with the Nuclear 

Waste Policy Act,” using the guidance and acceptance criteria from Section 1.7, “Compliance 

with the Nuclear Waste Policy Act of 1982,” of NUREG-1537, Parts 1 and 2.

As stated in SHINE PSAR Section 1.7, the SHINE facility does not produce either high-level 

nuclear wastes or spent nuclear fuel. Therefore, the Nuclear Waste Policy Act of 1982 is not 

applicable to this facility. As described in PSAR Chapter 11, “Radiation Protection Program and 

Waste Management,” SHINE has identified commercial disposition pathways for all of its 

radioactive waste.

As described in the American Medical Isotopes Production Act (42 U.S.C. 2065(f)), radioactive 

material resulting from the production of medical radioisotopes that has been permanently 

removed from a reactor or subcritical assembly, and for which there is no further use, is deemed 

to be low-level radioactive waste if it is acceptable under federal requirements for disposal as 

low-level radioactive waste. Since SHINE will be removing radioactive material resulting from 

the production of medical radioisotopes in a subcritical assembly, the staff has determined that 

the SHINE facility will produce low-level radioactive waste and will not produce high-level 

nuclear wastes. As discussed in Chapter 11, “Radiation Protection and Waste Management,” of 

this SER, SHINE has committed to following applicable NRC, DOE, and U.S. Department of 

Transportation regulations for disposal of its radioactive waste. Additionally, SHINE has 

identified licensed commercial disposal sites that can take receipt and dispose of the facility’s 

solid radioactive waste. The staff finds SHINE’s plans for handling radioactive waste 

demonstrate appropriate consideration of regulatory requirements for the types of waste at the 

facility. Further evaluation of SHINE’s plans for handling radioactive waste will occur in the 

review of SHINE’s FSAR.

As defined in 10 CFR 72.3, spent nuclear fuel or spent fuel means “fuel that has been 

withdrawn from a nuclear reactor following irradiation, has undergone at least one year’s decay 

since being used as a source of energy in a power reactor, and has not been chemically 

separated into its constituent elements by reprocessing....” Since SHINE will only be removing 

its target solution from subcritical assemblies, and not be constructing and operating a nuclear 

power reactor from which fuel will be removed, the staff has determined that the SHINE facility 

will not produce spent nuclear fuel.

Therefore, since SHINE will not be producing spent nuclear fuel or high-level nuclear wastes, 

the Nuclear Waste Policy Act of 1982 is not applicable to this facility.

The staff notes that a provision of the American Medical Isotopes Production Act of 2012 

(42 U.S.C. 2065(c)(3)(A)(ii)) states that DOE would take title to, and be responsible for, the final 

disposition of radioactive waste created by the irradiation, processing, or purification of uranium 

leased from DOE for medical radioisotope production, if it determines that the producer 

(e.g., SHINE) does not have access to a disposal path. For example, if a disposal pathway for 

Greater-Than-Class C Low-Level Radioactive Waste does not exist, DOE will be responsible for 

its disposal.
The Facility

1-21

Chapter 11 of the SHINE PSAR describes SHINE’s proposed radioactive waste management 

program, radioactive waste controls, and release of radioactive waste.

Therefore, the staff concludes that SHINE’s description of the applicability of the Nuclear Waste 

Policy Act of 1982 in Section 1.7 of the SHINE PSAR is sufficient, and meets the applicable 

regulatory requirements and guidance for the issuance of a construction permit in accordance 

with 10 CFR 50.35. 

Facility Modifications and History

The staff evaluated the sufficiency of SHINE’s descriptions of facility modifications and history, 

as presented in SHINE PSAR Section 1.8, “Facility Modifications and History,” using the 

guidance and acceptance criteria from Section 1.8, “Facility Modifications and History,” of 

NUREG-1537, Parts 1 and 2.

As stated in SHINE PSAR Section 1.8, “[t]his report is an application for construction of the 

SHINE facility. As there are no existing facilities, there have been no modifications, and there is 

no history to report. Therefore, this section is not applicable to the SHINE facility.”

The staff has determined that there are no existing facilities, there have been no modifications, 

and there is no history to report on the SHINE facility. Therefore, this section is not applicable 

to this facility.

Therefore, the staff concludes that SHINE’s description of facility modifications and history, as 

described in SHINE PSAR Section 1.8, is sufficient and meets the applicable regulatory 

requirements and guidance for the issuance of a construction permit in accordance with 

10 CFR 50.35.

2-1

SITE CHARACTERISTICS

The principal purpose of this chapter of the SHINE Medical Technologies, Inc. (SHINE or the 

applicant) construction permit safety evaluation report (SER) is to describe why the site selected 

is suitable for constructing and operating the SHINE facility. 

This chapter of the SHINE construction permit SER describes the technical review and 

evaluation of the U.S. Nuclear Regulatory Commission (NRC) staff' (the staff) of the preliminary 

design of the SHINE irradiation facility (IF) and radioisotope production facility (RPF) site 

characteristics as presented in Chapter 2, “Site Characteristics,” of the SHINE Preliminary 

Safety Analysis Report (PSAR), as supplemented by the applicant’s responses to requests for 

additional information (RAIs).

SER Chapter 2, “Site Characteristics,” provides an evaluation of SHINE’s site selection as 

presented in SHINE PSAR Sections 2.1, “Geography and Demography;” 2.2, “Nearby Industrial, 

Transportation, and Military Facilities;” 2.3, “Meteorology;” 2.4, “Hydrology;” 2.5, “Geology, 

Seismology, and Geotechnical Engineering;” and 2.6, “References.” 

Areas of Review

SHINE PSAR Sections 2.1 through 2.6 provide the bases for the site selection and describe the 

applicable site characteristics, including geography, demography, meteorology, hydrology, 

geology, seismology, and interaction with nearby installations and facilities. The SHINE site 

comprises two major facilities, the IF and the RPF. Both facilities are collocated on a single site.

The staff reviewed SHINE PSAR Sections 2.1 through 2.6 against applicable regulatory 

requirements using appropriate regulatory guidance and standards to assess the sufficiency of 

the site selection for the SHINE facility. As part of this review, the staff reviewed and evaluated 

descriptions and discussions of SHINE’s bases for the site selection. 

Areas of review for this section included the following:

• The geography and demography descriptions of the site area and facility location used 

to assess the acceptability of the SHINE site.

• The description of locations and routes where potential external hazards or hazardous 

materials present or may reasonably be expected to be present during the projected 

lifetime of the SHINE site. 

• The description of averages and extremes of climatic conditions and regional 

meteorological phenomena that could affect the safe design and siting of the SHINE site.

• The description of the SHINE site and safety-related elevations, structures, and systems 

from the standpoint of hydrologic considerations including the topographic map showing 

the proposed changes to grading and to natural drainage features.
Site Characteristics

2-2

Summary of Application

As stated above, the SHINE site contains two major facilities, the IF (consisting of eight 

irradiation units) and the RPF. Both facilities are to be collocated in a single building on the site.

The SHINE site will be located on agricultural property in the City of Janesville, Rock County, 

Wisconsin. The SHINE site will be located on the south side of the City of Janesville corporate 

boundaries, and the densely populated parts of the city are more than 1 mile (mi) 

(1.6 kilometers [km]) to the north. Approximately 3.7 mi (6.0 km) to the south of the SHINE site 

is the northern city limits of the City of Beloit, Wisconsin, and approximately 60 mi (96.6 km) 

east of the SHINE site is Lake Michigan. The SHINE site is centered at 42° 37’ 26.9” north 

latitude, and 89° 1’ 29.5” west longitude. The City of Janesville, relative to the City of 

Milwaukee, Wisconsin and the City of Chicago, Illinois is shown in Figure 2.1-1.

The site boundaries encompass approximately 91 acres (36.8 hectares) of land. The finished 

site grade elevation is approximately 827 feet (ft) (252 meters [m]) per the North American 

Vertical Datum of 1988. The SHINE site and adjacent ground within a radius of approximately 

1.6 km (1 mi) is generally flat. The area surrounding the site is rural, with most land used for 

agriculture (about 83 percent of Rock County is farmland). The general site location is shown in 

Figure 2.2-2.

The area within 8 km (5 mi) of the SHINE site supports a population estimated to be about 

43,000 people, who mostly live north of the SHINE site in and around the City of Janesville, 

Wisconsin. Specifically, most of the population is located north-northwest (within 1 km [0.6 mi]) 

or northwest (1 to 2 km [0.6 to 1.2 mi]) of the SHINE site; while further from the site (4 to 8 km 

[2.5 to 5 mi]), most of the population is located north of the SHINE site, in and around the City of 

Janesville. 

SHINE estimated the 2050 population surrounding the SHINE site at about 67,000 persons 

(about a 36 percent increase from the 2010 population), with the largest percentage (at about 

70 percent) of increases occurring south of the site. 

The total 2013 population of the City of Janesville was about 63,600 people, although a portion 

of that population lives outside of an 8 km (5 mi) radius from the site.

The nearest permanent residence is located approximately 0.80 km (0.50 mi) northwest of the 

center of the SHINE site. There are permanent residences in two other directions that are only 

slightly farther away; a house located approximately 0.86 km (0.54 mi) north-northwest of the 

center point and a house located approximately 0.94 km (0.59 mi) to the south-southwest. In 

the SHINE PSAR, the joint frequency data indicate that the prevailing wind direction is from the 

west followed by the south, and that wind is from the north-northeast the least. A resident living 

downwind of prevailing wind (i.e., east or north of the site) could be most affected by SHINE’s 

operation. The nearest resident in the easterly direction is located 1.2 km (0.73 mi) to the 

east-northeast, while to the north the nearest resident is also 1.2 km (0.73 mi) from the SHINE 

site. 
Site Characteristics

2-3

Figure 2.1-1. City of Janesville
Site Characteristics

2-4

Figure 2.2-2. SHINE Facility ― General Location Map
Site Characteristics

2-5

In addition to the permanent residents around the SHINE site, there are people who enter this 

area temporarily for activities such as employment, education, recreation, medical care, and 

lodging. SHINE estimated a 2010 total transient population of about 27,600 persons. Most of 

the transient population is either in education (approximately 54 percent) or employment 

(approximately 36 percent). SHINE also estimated a 2010 total weighted transient population of 

about 8,100 persons.

There are several major industrial and transportation facilities located within 8 km (5 mi) of the 

SHINE site. These include industrial facilitates, pipelines, highways, railroads, and an airport, 

which are shown in Figure 2.2-3. 

● Industrial Facilities

- Abitec Corporation 

- Crop Production Services 

- Evonik Goldschmidt Corporation 

- Janesville Jet Center 

- School District of Beloit Turner 

- Seneca Foods Corporation 

- Simmons Manufacturing Co 

- United Parcel Service ● Pipelines

- Alliant Energy Natural Gas Pipelines

- ANR Natural Gas Pipeline ● Highways

- Interstate I-90/39

- U.S. Highways 14 and 51

- Wisconsin State Routes 11 and 26 ● Railroads

- Union Pacific Railroad

- Canadian Pacific Railroad

- Wisconsin & Southern Railroad ● Airports

- Southern Wisconsin Regional Airport 

- Mercy Hospital Heliport

There are no major military facilities located within 8 km (5 mi) of the SHINE site, although 

military aircraft do sometimes utilize the Southern Wisconsin Regional Airport (SWRA).

A small percentage of Rock County is industrial, with the majority of industries in the larger cities 

of Janesville and Beloit. The only planned industrial growth identified within 8 km (5 mi) of the 

SHINE site is expansion of the SWRA. The airport plans to expand runways away from US 51. 

The airport operations are not expected to grow significantly. The Janesville and Beloit 

Comprehensive Plans do not provide details of any planned industrial growth.

SHINE PSAR Section 2.2.2, “Air Traffic,” discusses air traffic located within 10 mi (16 km) of the 

SHINE facility (distance from the center of the SHINE site to the nearest edge of the airway). 

SHINE also describes its analysis of aircraft hazards associated with these airways, including 

approach and holding patterns near its proposed facility. SHINE PSAR Section 2.2.3, “Analysis 

of Potential Accidents at Facilities,” describes the analysis of postulated accidents and possible 

effects that could occur at the SHINE facility, including explosions, flammable vapor clouds, 

toxic chemicals, and fires. 
Site Characteristics

2-6

Figure 2.2-3. Nearby Industrial and Transportation Facilities

SHINE PSAR Section 2.3 describes the general and local climate, including historical averages 

and extremes of climatic conditions and regional metrological phenomena. The SHINE site is 
Site Characteristics

2-7

located in a region with the Köeppen classification, which is a humid continental climate with 

warm summers, snowy winters, and humid conditions. The climate features a large annual 

temperature range and frequent short duration temperature changes. Although there are no 

pronounced dry seasons, most of the annual precipitation falls during the summer. During the 

autumn, winter, and spring, strong synoptic scale surface cyclones and anticyclones frequently 

move across the site region. During the summer, synoptic scale cyclones are usually weaker 

and pass north of the site region. Most air masses that affect the site region are generally of 

polar origin; however, air masses occasionally originate from arctic regions, or the Gulf of 

Mexico. Air masses originating from the Gulf of Mexico generally do not reach the site region 

during winter months. There are occasional episodes of extreme heat or high humidity in the 

summer. The windiest months generally occur during the spring and autumn. The annual 

average number of days with thunderstorms varies from approximately 45 days at the 

southwest corner of the state of Wisconsin, to approximately 35 days at the northeast corner of 

the state. Hail is most frequent in the southwestern and west central portions of the state, and 

is most common during summer months, peaking in late July. Tornadoes are relatively 

infrequent. Winter storms that affect the region generally follow one of three tracks: Alberta, 

Panhandle, or Gulf Coast. During an average winter, the ground is covered with snow about 

60 percent of the time. In addition, the applicant also discusses the potential meteorological 

effects to the SHINE facility and discusses the dispersion analysis of airborne releases, in both 

restricted and unrestricted areas, from routine releases during normal operations and from 

postulated releases resulting from accidents.

SHINE PSAR Section 2.4.1, “Hydrological Description,” identifies the SHINE site surface water, 

groundwater aquifers, types of on-site groundwater use, sources of recharge, present known 

withdrawals and likely future withdrawals, flow rates, travel time, gradients, and other properties 

that affect movement of accidental contaminants in groundwater, groundwater levels beneath 

the site, seasonal and climatic fluctuations, monitoring and protection requirements, and 

man-made changes that have the potential to cause long-term changes in local groundwater 

regime.

In SHINE PSAR Section 2.4.2, “Floods,” the applicant indicates that flooding near the proposed 

SHINE site is very unlikely to be caused by local intense precipitation or by the Rock River or 

unnamed tributary overflowing their banks. The applicant describes its analysis of the potential 

flooding from other natural events, including surges, seiches, tsunami, dam failures, flooding 

caused by landslides, and effects of ice formation on water bodies. The applicant notes that the 

Rock River and the unnamed tributary stream are subject to flooding throughout the year. The 

largest potential for flooding occurs during the spring as a result of precipitation and snow melt. 

Peak flows occur during the winter and are primarily caused by ice jams.

SHINE PSAR Section 2.5.1, “Regional Geology,” describes the regional geology within 

about 322 km (200 mi) of the proposed site, including regional physiography and 

geomorphology; tectonic provinces and structures within the basement rocks; bedrock geology 

including stratigraphy, lithology, and structure; magnetic and gravity geophysical anomalies; and 

surficial geology and glacial history. SHINE PSAR Section 2.5.2, “Site Geology,” describes the 

geology within about 8 km (5 mi) of the proposed site. Specifically, this section describes the 

stratigraphy and depth to bedrock, structural geology, site soils conditions, and non-seismic 

geological hazards. SHINE PSAR Section 2.5.3, “Seismicity,” describes the regional geology 

within about 322 km (200 mi) of the proposed site, including historic earthquakes and felt 

intensities. SHINE PSAR Section 2.5.4, “Maximum Earthquake Potential,” describes the 

historical maximum expected moment magnitude from past earthquakes, and frequency of 

occurrence. SHINE PSAR Section 2.5.5, “Vibratory Ground Motion,” presents an evaluation of 
Site Characteristics

2-8

the earthquake ground shaking expected at the proposed site. Because most of the regional 

geological structures are not considered to be seismically capable, the analysis of earthquake 

ground shaking at the proposed site is based on interpolation of the national seismic hazard 

model. The development of an earthquake ground motion design response spectrum follows 

the procedures set out in the structural codes and standards applicable to Wisconsin. SHINE 

PSAR Section 2.5.6, “Surface Faulting,” presents an evaluation of the earthquake ground 

shaking expected at the proposed site. Because most of the regional geological structures are 

not considered to be seismically capable, the analysis of earthquake ground shaking at the site 

is based on interpolation of the national seismic hazard model. The development of an 

earthquake ground motion design response spectrum follows the procedures set out in the 

structural codes and standards applicable to Wisconsin. SHINE PSAR Section 2.5.7, 

“Liquefaction Potential,” describes the liquefaction potential within the proposed site. 

Regulatory Basis and Acceptance Criteria

The staff reviewed SHINE PSAR Chapter 2 against applicable regulatory requirements, using 

regulatory guidance and standards, to assess the sufficiency of the bases and the information 

provided by SHINE for the selection of the SHINE site for the issuance of a construction permit. 

In accordance with paragraph (a) of Title 10 of the Code of Federal Regulations (10 CFR) 

50.35, “Issuance of construction permits,” a construction permit authorizing SHINE to proceed 

with construction may be issued once the following findings have been made:

(1) SHINE has described the proposed design of the facility, including, but not limited to, 

the principal architectural and engineering criteria for the design, and has identified the 

major features or components incorporated therein for the protection of the health and 

safety of the public. 

(2) Such further technical or design information as may be required to complete the safety 

analysis, and which can reasonably be left for later consideration, will be supplied in 

the final safety analysis report (FSAR).

(3) Safety features or components, if any, which require research and development have 

been described by SHINE and a research and development program will be conducted 

that is reasonably designed to resolve any safety questions associated with such 

features or components. 

(4) On the basis of the foregoing, there is reasonable assurance that: (i) such safety 

questions will be satisfactorily resolved at or before the latest date stated in the 

application for completion of construction of the proposed facility, and (ii) taking into 

consideration the site criteria contained in 10 CFR Part 100, “Reactor Site Criteria,” the 

proposed facility can be constructed and operated at the proposed location without 

undue risk to the health and safety of the public.

With respect to the last of these findings, the staff notes that the requirements of 

10 CFR Part 100 are specific to nuclear power reactors, and therefore not applicable to the 

SHINE facility. However, the staff evaluated SHINE’s site specific conditions using site criteria 

similar to 10 CFR Part 100, by using the guidance in NUREG-1537, Part 1, “Guidelines for 

Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Format and 

Content,” issued February 1996 (Reference 4) 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 (Reference 5). The staff’s review 
Site Characteristics

2-9

evaluated the geography and demography of the site; nearby industrial, transportation, and 

military facilities; site meteorology; site hydrology; and site geology, seismology, and 

geotechnical engineering to ensure that issuance of the construction permit will not be inimical 

to public health and safety. The staff’s review evaluated structures, components, equipment, 

and systems designed to ensure safe operation, performance, and shutdown when subjected to 

extreme weather, floods, seismic events, missiles (including aircraft impacts), chemical and 

radiological releases, and loss of offsite power.

Applicable Regulatory Requirements

The applicable regulatory requirements for the evaluation of the SHINE site characteristics are 

as follows:

• 10 CFR 50.34, “Contents of applications; technical information,” paragraph (a), 

“Preliminary safety analysis report.”

Regulatory Guidance and Acceptance Criteria

In applying guidance and acceptance criteria, the staff used its judgment as to which 

acceptance criteria were relevant to SHINE’s proposed facility, as much of this guidance was 

originally developed for nuclear reactors. Given the similarities in SHINE’s proposed facility and 

non-power research reactors, the staff used established guidance documents and the 

Commission’s regulations to determine the acceptance criteria for demonstrating compliance 

with 10 CFR regulatory requirements. For example, the staff used the following: 

• NUREG-1537, Part 1, “Guidelines for Preparing and Reviewing Applications for the 

Licensing of Non-Power Reactors, Format and Content.”

• NUREG-1537, Part 2, “Guidelines for Preparing and Reviewing Applications for the 

Licensing of Non-Power Reactors, Standard Review Plan and Acceptance Criteria.” 

• “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 (Reference 6).

• “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 (Reference 7).

As stated in the ISG Augmenting NUREG-1537, the staff determined that certain guidance 

originally developed for heterogeneous non-power research and test reactors is applicable to 

aqueous homogenous facilities and production facilities. SHINE used this guidance to inform 

the design of its facility and prepare its PSAR. The staff’s use of reactor-based guidance in its 

evaluation of the SHINE PSAR is consistent with the ISG Augmenting NUREG-1537.

As appropriate, additional guidance (e.g., NRC regulatory guides, Institute of Electrical and 

Electronics Engineers (IEEE) standards, American National Standards Institute/American 

Nuclear Society (ANSI/ANS) standards) has been used in the staff’s review of SHINE’s PSAR. 

The use of additional guidance is based on the technical judgment of the reviewer, as well as 
Site Characteristics

2-10

references in NUREG-1537, Parts 1 and 2; the ISG Augmenting NUREG-1537, Parts 1 and 2; 

and the SHINE PSAR. Additional guidance documents used to evaluate SHINE’s PSAR are 

provided as references in Appendix B, “References,” of this SER.

Review Procedures, Technical Evaluation, and Evaluation Findings

SHINE PSAR Chapter 2 discusses the SHINE site characteristics including the geographical, 

geological, seismological, hydrological, and meteorological characteristics of the site and the 

vicinity in conjunction with present and projected population distributions, industrial facilities and 

land use, and site activities and controls. The staff’s review of the SHINE site considers the site 

characteristics; design and analyses of structures, systems, and components; radiation 

protection and waste management programs; and accident analyses.

The staff performed an evaluation of the technical information presented in SHINE PSAR 

Chapter 2, as supplemented by the applicant’s responses to RAIs, to assess the sufficiency of 

SHINE’s site characteristics for the issuance of a construction permit, in accordance with 

10 CFR 50.35. The sufficiency of the preliminary design and performance of the SHINE facility 

site characteristics is determined by ensuring the design and performance meet applicable 

regulatory requirements, guidance, and acceptance criteria, as discussed in Section 2.3, 

“Regulatory Basis and Acceptance Criteria,” of this SER. A summary of the technical evaluation 

is described in Section 2.5, “Summary and Conclusions.”

Geography and Demography

The staff evaluated the sufficiency of SHINE’s site characteristic geography and demography 

description, as described in SHINE PSAR Section 2.1 using the guidance and acceptance 

criteria from Section 2.1, “Geography and Demography,” of NUREG-1537, Parts 1 and 2, and 

Section 2.1, “Geography and Demography,” of the ISG Augmenting NUREG-1537, Parts 1 

and 2.

Consistent with the review procedures of the ISG Augmenting NUREG-1537, Part 2, 

Section 2.1, the staff compared and verified the SHINE site characteristics geography and 

demography with the bases for the site selection, as presented in SHINE PSAR Section 2.1.

NUREG-1537, Part 1, Section 2.1, states, in part, that the applicant should provide the 

descriptions of the site area and facility location to assess the acceptability of the SHINE site. 

The applicant should provide the following information: (1) specification of the location with 

respect to latitude and longitude, political subdivisions, and prominent natural and manmade 

features of the area; (2) site area map to determine the distance from the facility to the boundary 

lines of the exclusion area, including consideration of the location, distance, and orientation of 

plant structures with respect to highways, railroads, and waterways that traverse or lie adjacent 

to the exclusion area; and (3) a description of population distributions that address population in 

the site vicinity, including transient populations.

NUREG-1537, Part 1, Section 2.3.2, “Site Meteorology,” states that sufficient information should 

be provided “for the dispersion analyses of airborne releases from the facility.” Also, 

NUREG-1537, Part 2, Section 2.1, states that the staff should determine sufficient information is 

provided to conclude that “land use in the area of the facility is sufficiently stable or well enough 

planned that likely potential radiological risks to the public can be analyzed and evaluated with 

reasonable confidence.” Therefore, the staff requested, in RAI 2.1-1 (Reference 14), that the 

applicant provide a tabulation of the distance from the center of the site and/or the expected 
Site Characteristics

2-11

airborne release point to the site boundary in each of the 16 compass directions. This 

requested information would enable the staff to determine whether SHINE meets the applicable 

acceptance criteria of NUREG-1537, Part 2, Section 2.1. 

In response to RAI 2.1-1 (Reference 20), SHINE provided the distances from a release point to 

the site boundary in each of the 16 compass directions. The staff finds the applicant’s response 

supports the dispersion analyses of airborne releases from the facility, and therefore satisfies 

the acceptance criteria of NUREG-1537, Part 2, Section 2.1.

NUREG-1537, Part 2, Section 2.1, states that the PSAR should contain sufficient demographic 

information to allow accurate assessments of the potential radiological impact on the public 

resulting from the siting and operation of the proposed facility. In SHINE PSAR Section 2.1.2.1, 

“Resident Population,” the applicant provided the distance and direction to the three nearest 

residences for use in its assessments of potential radiological impact on the public resulting 

from the siting and operation of the proposed facility. Therefore, in RAI 2.1-2 (Reference 14), 

the staff requested information regarding the distances to the nearest residences in the 

remaining 13 compass directions. In response to RAI 2.1-2 (Reference 20), the applicant 

provided the approximate distance between the SHINE site center and the nearest residence in 

each of the 13 remaining compass directions. Based on its review of the distances provided in 

the SHINE response to RAI 2.1-2 and the PSAR meteorological data, the staff confirmed that 

the nearest resident in the northwest direction is also the critical resident. The staff finds the 

applicant’s response satisfies the acceptance criteria of Part 2, Section 2.1.

The staff reviewed the information provided in SHINE PSAR Section 2.1 and concluded that this 

section of the SHINE PSAR forms the basis for evaluations (e.g., dose calculations) performed 

in other chapters. The distance-direction relationships specified in the PSAR to area 

boundaries, roads, railways, waterways, prevailing winds, and other significant features of the 

area were independently verified using a third-party-supplied map.

On the basis of its review, the staff has determined that the level of detail provided on SHINE’s 

geography and demography demonstrates an adequate design basis and satisfies the 

applicable acceptance criteria of NUREG-1537, Part 2, Section 2.1, allowing the staff to find 

that: (1) the information is sufficiently detailed to provide an accurate description of the 

geography surrounding the facility; (2) the demographic information is sufficient to allow 

accurate assessments of the potential radiological impact on the public resulting from the siting 

and operation of the proposed facility; and (3) there is reasonable assurance that no geographic 

or demographic features render the site unsuitable for operation of the proposed facility.

Therefore, the staff concludes that the SHINE facility’s geography and demography, as 

described in SHINE PSAR Section 2.2 and supplemented by the applicant’s responses to RAIs, 

is sufficient and meets the applicable regulatory requirements and guidance for the issuance of 

a construction permit in accordance with 10 CFR 50.35.

Nearby Industrial, Transportation, and Military Facilities

The staff evaluated the sufficiency of the SHINE site characteristics regarding nearby industrial, 

transportation, and military facility descriptions, as described in SHINE PSAR Section 2.2, using 

the guidance and acceptance criteria from Section 2.2, “Nearby Industrial, Transportation, and 

Military Facilities,” of NUREG-1537, Parts 1 and 2, and Section 2.2, “Nearby Industrial, 

Transportation, and Military Facilities,” of the ISG Augmenting NUREG-1537, Parts 1 and 2.
Site Characteristics

2-12

NUREG-1537, Part 2, does not specifically provide acceptance criteria for evaluating the aircraft 

accident probability posed by airports and airways. Two sources of potential acceptance criteria 

are: (1) NUREG-0800, “Standard Review Plan for the Review of Safety Analysis Reports for 

Nuclear Power Plants: LWR Edition,” Section 3.5.1.6, “Aircraft Hazards,” which states, in part, 

that accidents “...with a probability of occurrence greater than an order of magnitude of 10-7 per 

year should be considered in the design of the plant,” and (2) International Atomic Energy 

Agency (IAEA)-TECDOC-1347, “Consideration of External Events in the Design of Nuclear 

Facilities other than Nuclear Power Plants, with Emphasis on Earthquakes” (Reference 41), 

Section 4.3, “Design Basis for Aircraft Crash,” which has an acceptance criteria for aircraft 

accident probability of less than 10-5 per year. 

Consistent with the review procedures in NUREG-1537, Part 2, Section 2.2, the staff confirmed 

that any hazards to the SHINE facility posed by normal operation and potential malfunctions and 

accidents at the nearby manmade stationary facilities and those related to transportation have 

been described and analyzed to the extent necessary to evaluate the potential radiological risks 

to the facility staff, the public, and the environment.

NUREG-1537, Part 1, Section 2.2, states, in part, that “the applicant should establish whether 

the effects of potential accidents in the vicinity of the facility from present and projected 

industrial, transportation, and military installations and operations should be used in the safety 

analyses and should establish the facility design parameters related to accidents selected. The 

applicant should consider all facilities and activities within 8 km of the facility. Facilities and 

activities at greater distances should be included as appropriate to their significance of accident 

impact on the facility.”

In SHINE PSAR Section 2.2.1, “Locations and Routes,” the applicant provides maps showing 

locations and distance of nearby industrial facilities, pipelines, waterways, highways, railroads, 

airports, and airways from the SHINE site. The staff confirmed that any hazards to the facility 

posed by normal operation and potential malfunctions and accidents at the nearby manmade 

stationary facilities and those related to transportation have been described and analyzed to the 

extent necessary to evaluate the potential radiological risks to the facility staff, the public, and 

the environment.

In SHINE PSAR Section 2.2.2, the applicant describes the air traffic, including airports, airways, 

and military airports and training, approach and holding patterns near the proposed SHINE site, 

and the evaluation and result of its analyses of the aircraft hazards associated with this air 

traffic. In PSAR Section 2.2.2, the applicant also calculated the aircraft crash probabilities due 

to operations at the SWRA. The staff finds acceptable the methodologies utilized by the 

applicant to calculate air craft accident probabilities and independently confirmed the applicant’s 

calculations.

NUREG-1537, Part 2, Section 2.2, states, in part, that “[t]he reviewer should focus on facilities, 

activities, and materials that may reasonably be expected to be present during the projected 

lifetime....” The staff noted that from 2003 to 2012, the Southern Wisconsin AirFest was an 

activity held at the SWRA. Therefore, in RAI 2.2-2(a) (Reference 14), the staff requested 

additional information regarding the Southern Wisconsin AirFest.

In response to RAI 2.2-2(a) (Reference 20), SHINE provided an evaluation of the accident 

probability due to the increased number of takeoffs and landings should the Southern Wisconsin 

AirFest return to the SWRA. The staff finds that the SHINE provided evaluation shows that the 
Site Characteristics

2-13

accident probability due to the addition of a future air show at the SWRA is bounded by the 

current analysis provided in PSAR Section 2.2. 

RAI 2.2-4(a) (Reference 15) requested information regarding why a potential accident during an 

AirFest performance (or rehearsal) would not adversely affect the SHINE facility. In response, 

SHINE indicated that the site exists entirely within the lateral boundaries of the SWRA Class E 

airspace, and that 14 CFR 91.303, “Aerobatic flight,” paragraph (c) prohibits aerobatic flight in 

Class E airspace. Furthermore, according to Department of Transportation Order 8900.1, 

“Flight Standards Information Management System,” (Reference 38), in order to not detract from 

safety or create a hazard to any non-participants or spectators, the location of the SHINE facility 

would need to be taken into consideration by the Federal Aviation Administration (FAA) when 

authorizing any future aviation events at the SWRA. The staff finds that applicant’s response 

provides a sufficient approach to reduce the potential of an accident impacting the facility during 

potential future AirFest events.

In RAI 2.2-2(b) (Reference 14), the staff requested that the applicant provide justification for 

utilizing IAEA-TECDOC-1347, as opposed to NUREG-0800, Section 3.5.1.6 acceptance criteria 

for aircraft accidents. In its response, the applicant states that IAEA-TECDOC-1347 applies 

specifically to nuclear installations that are not nuclear power plants, such as research reactors 

and facilities for fuel conversion, fabrication and reprocessing. Because the SHINE facility is not 

a power reactor, the facility is considered in the scope of IAEA-TECDOC-1347. In addition, the 

applicant states that the use of the acceptance criteria contained in IAEA-TECDOC-1347 is 

appropriate for the design of the SHINE facility. In RAI 2.2-4(b), the staff requested information 

to justify use of the IAEA’s aircraft accident probability of 10-5 yr-1

, as opposed to utilizing an 

aircraft accident threshold probability of 10 -6 yr-1 (Reference 39) as supported by NRC 

precedent and DOE standards on aircraft crashes (DOE-STD-3014-96, “Accident Analysis for 

Aircraft Crash into Hazardous Facilities,” October 1996, Reaffirmed May 2006) (Reference 40).

In response to RAI 2.2-4(b), SHINE provided an updated evaluation of the aircraft hazard using 

an aircraft accident threshold probability of 10-6 per year. The updated evaluation used updated 

aircraft operation flight data from FAA, which indicated fewer operations than were used in the 

PSAR evaluation. The total crash probabilities calculated by the updated SHINE evaluation are 

provided in SER Table 2.2-1.

Table 2.2-1. Total Crash Probability

Large NonMilitary AircraftSmall NonMilitary Aircraft Military Aircraft

Airport 2.9 × 10-7 2.6 × 10-4 1.5 × 10-7

Airways 1.5 × 10-8 1.9 × 10-6 1.6 × 10-7

Total 3.0 × 10-7 2.6 × 10-4 3.1 × 10-7

As Table 2.2-1 indicates, the calculated crash probability (2.6 × 10-4 yr-1

) for small non-military 

aircraft exceeds the threshold probability of 10-6 yr-1

, while the combined probability of all other 

aircraft crashes (6.1 × 10-7 yr-1

) does not exceed the threshold probability. Thus, the 

safety-related structures of the SHINE facility must be designed to withstand the impact of a 

small non-military aircraft. The staff finds that the revised analysis meets NRC precedence and 

is therefore acceptable.

In SHINE PSAR Section 2.2.3, the applicant identifies and describes its analysis of potential

accidents to be considered as design-basis events and the potential effects of those accidents 
Site Characteristics

2-14

on the facility, in terms of design parameters (e.g., overpressure, missile energies) or physical 

phenomena (e.g., impact, flammable or toxic clouds). Design-basis events, internal and 

external to the SHINE facility, are defined as those accidents that have a probability of 

radiological release to the public on the order of magnitude of 10-7 per year, or greater, with the 

potential consequences serious enough to affect the safety of the facility. The following 

accident categories were considered in selecting design-basis events: explosions, flammable 

vapor clouds (delayed ignition), toxic chemicals, and fires. The staff reviewed and finds 

acceptable the methodologies utilized by the applicant to calculate the effects of potential 

accidents involving hazardous materials or activities on site and in the vicinity of the SHINE site. 

The staff also independently confirmed the applicant’s calculations.

NUREG-1537, Part 2, Section 2.2, states, in part, that the PSAR should provide information 

“complete enough for evaluations of potential risks posed by these facilities to the safe 

operation and shutdown of the reactor during its projected lifetime.”

SHINE PSAR Section 2.2.3.1.3, “Toxic Chemicals,” states, “[t]he control room is not 

safety-related. The control room operators are not required to operate safety-related equipment 

to ensure the safety of the public. Therefore, a toxic gas release is not a hazard to the facility.” 

The staff in RAIs 2.2-1 and 2.2-3 (Reference 14), requested that SHINE provide a description of 

why an onsite or offsite toxic gas release during normal operations would not initiate an accident 

that could endanger the public and/or cause damage to the facility, should the control room 

operators become incapacitated. 

In response to these RAIs, the applicant evaluated the potential for an offsite toxic gas release 

within 5 mi (8 km) of the site. Both stationary and mobile sources of hazardous chemicals were 

analyzed. Sources were identified, screened, or evaluated based on Regulatory Guide 1.78, 

“Evaluating the Habitability of a Nuclear Power Plant Control Room During a Postulated 

Hazardous Chemical Release,” guidance (Reference 42) and criteria. The evaluation was 

performed using Version 5.4.4 of the ALOHA (Areal Locations of Hazardous Atmospheres) 

computer program from the National Oceanic and Atmospheric Administration (Reference 43). 

In NUREG-1851, “Safety Evaluation Report for the American Centrifuge Plant in Piketon, Ohio,” 

(Reference 44), the staff determined that the “ALOHA code is well-known ... and acceptable.” 

Approximately 12 different potentially hazardous chemicals were evaluated. Of the chemicals 

evaluated, the applicant determined that only an ammonia release could have a greater 

than 10-6 per year potential to result in an uninhabitable control room; however, the applicant 

also determined that following such an ammonia release, the control room operators would 

have sufficient time (i.e., at least 2 minutes per acceptance criteria in Regulatory Guide 1.78) to 

take protective measures (e.g., shut down the facility). Since the regulatory guide is used for 

other 10 CFR Part 50, “Domestic Licensing of Production and Utilization Facilities,” licensees 

(e.g., nuclear power plants), the staff finds that use of Regulatory Guide 1.78 is appropriate for 

evaluating the SHINE control room habitability.

The staff finds that the applicant’s response to RAI 2.2-1 and RAI 2.2-3 satisfies the acceptance 

criteria of the NUREG-1537, Part 2, Section 2.2.

On the basis of its review, the staff has determined that: (1) the level of detail and analyses 

provided in SHINE PSAR Section 2.2 demonstrates an adequate design basis and satisfy the 

applicable acceptance criteria of NUREG-1537, Part 2, Section 2.2, and (2) the applicant 

discusses all nearby manmade facilities and activities that could pose a hazard to its operations. 

There is reasonable assurance that normal operations of such facilities would not affect SHINE 
Site Characteristics

2-15

operations. In addition, the analyses in PSAR Chapter 13, “Accident Analysis,” of potential 

malfunctions or accidents at nearby manmade facilities and consideration of normal activities at 

those facilities show that safe shutdown would not be prevented, and no undue radiological risk 

to the public, the environment, or the operating staff is predicted. The potential consequences 

of these events at nearby facilities are considered or bounded by applicable accidents analyzed 

in Chapter 13 of SHINE PSAR.

Based on SHINE PSAR Section 2.2, as supplemented by the applicant’s responses to RAIs, the 

staff finds that the applicant’s description of operations and potential accidents at nearby 

manmade facilities and activities (i.e., industrial, transportation, and military sufficient and meets 

the applicable regulatory requirements and guidance for the issuance of a construction permit in 

accordance with 10 CFR 50.35.

Meteorology

The staff evaluated the sufficiency of the applicant’s description of site meteorology, as 

described in SHINE PSAR Section 2.3 using the guidance and acceptance criteria from 

Section 2.3, “Meteorology,” of NUREG-1537, Part 2.

Consistent with the review procedures of the ISG Augmenting NUREG-1537, Part 2, 

Section 2.3, the staff verified that sufficient documented and referenced historical information is 

provided for the necessary analyses of meteorological effects at the proposed site. The staff 

determined that data provided address both short-term conditions applicable to accidental 

releases of radioactive material and long-term averages applicable to releases during normal 

reactor operation. The staff also verified that the predicted frequencies of recurrence and 

intensities of severe weather conditions are documented.

NUREG-1537, Part 1, Section 2.3, states, in part, that “the applicant should describe the 

meteorology of the site and its surrounding areas. Sufficient data on average and extreme 

conditions should be included to permit an independent evaluation.”

SHINE PSAR Section 2.3.1, “General and Local Climate,” provides a general and local climate 

analysis, with respect to historical and annual frequencies of severe weather for the proposed 

site, including the following:

• Identification of region with climate representative of the project site.

• Regional data sources.

• Identification and selection for analysis of weather monitoring stations located within the 

site climate region.

• Extreme wind.

• Tornadoes and waterspouts.

• Water equivalent precipitation extremes.

• Hail, snowstorms and ice storms, thunderstorms and lightning.

• Snowpack and probable maximum precipitation.

• Design dry bulb and wet bulb temperatures.

• Extreme dry bulb temperatures.

• Restrictive dispersion conditions.

• Air quality.

• Climate change.
Site Characteristics

2-16

The staff notes that in response to RAI 3.2-1, the applicant explained that the snowpack load 

data presented in PSAR Sections 2.3.1.2.9, “Snowpack and Probable Maximum Precipitation 

(PMP),” and 3.2.3, “Snow, Ice, and Rain Loading,” are equivalent, since both utilize American 

Society of Civil Engineers Standard ASCE 7-05, “Minimum Design Loads for Buildings and 

Other Structures,” Figure 7-1. (Note, the SHINE response to RAI 3.2-1 pointed out that 

PSAR Sections 2.3.1.2.9 and 19.3.2.3.6 erroneously states the units for the snowpacks in 

inches, when the ASCE 7-05, Figure 7-1 snowpack units actually in pounds per square foot 

(lbs/ft2

). This error has been corrected in the SHINE PSAR. The staff’s evaluation of the 

response to RAI 3.2-1 is in Chapter 3, “Design of Structures, Systems, and Components,” of this 

SER.

In SHINE PSAR Section 2.3.2, “Site Meteorology,” the applicant provided its local climate 

analysis for the dispersion conditions in the vicinity of the proposed site. The applicant provided

the meteorological information to be used in Chapters 11 and 13 for both long-term and 

short-term dispersion calculations. The applicant also provided several alternative sources of 

meteorological information and plans for access to meteorological information during the 

proposed license period.

On the basis of its review, the staff has determined that the level of detail and analyses provided 

in SHINE PSAR Section 2.3 demonstrates an adequate design basis and satisfies the 

acceptance criteria of NUREG-1537, Part 2, Section 2.3, allowing the staff to find that: (1) the 

meteorological history and projections for the proposed site have been prepared in an 

acceptable form, (2) these projections have been factored into the choice of facility location and 

design sufficiently to provide assurance that no weather-related event is likely to cause damage 

to the facility during its lifetime that could release uncontrolled radioactive material to the 

unrestricted area, (3) the meteorological information is sufficient for analyses applicable to and 

commensurate with the risks of the dispersion of airborne releases of radioactive material in the 

unrestricted environment at the proposed site, and (4) the methods and assumptions are 

applied to releases from both normal operations and postulated accidents at the facility.

Based on SHINE PSAR Section 2.3, as supplemented by the applicant’s responses to RAIs, the 

staff finds that the applicant’s description of general, local, and site meteorology sufficient and 

meets the applicable regulatory requirements and guidance for the issuance of a construction 

permit in accordance with 10 CFR 50.35.

Hydrology

The staff evaluated the sufficiency of SHINE’s site characteristic regarding hydrology, as 

described in SHINE PSAR Section 2.4 using the guidance and acceptance criteria from 

Section 2.4, “Hydrology,” of NUREG-1537, Part 2.

Consistent with the review procedures of the NUREG-1537, Part 2, Section 2.4, the staff verified 

that the proposed site was selected with due consideration of potential hydrologic events and 

consequences, including any that could be initiated by either local or distant seismic 

disturbances. In addition, the staff confirmed that the design bases were incorporated into the 

facility design to address predicted hydrologic events, accidental release or leakage of primary 

coolant, and radioactive contamination of ground or surface waters.

NUREG-1537, Part 1, Section 2.4 states, in part, that:
Site Characteristics

2-17

...the applicant should give sufficient information to allow an independent 

hydrologic engineering review to be made of all hydrologically related design 

bases, performance requirements, and bases for operation of structures, 

systems, and components important to safety. Sufficient information should also 

be provided about the water table, groundwater, and surface water features at 

the proposed site for analyses and evaluations in Chapters 11 and 13 of 

consequences of uncontrolled release of radioactive material from pool leakage 

or failure, neutron activation of soils in the vicinity of the proposed [site], or 

deposition and migration of airborne radioactive material released to the 

unrestricted area. 

In SHINE PSAR Section 2.4, the applicant provides a detailed description of hydrological 

characteristics for its proposed site, including floods, probable maximum flood on streams and 

rivers, potential dam failures, probable maximum surge and seiche flooding, probable maximum 

tsunami hazards, ice effects, cooling water canals and reservoirs, channel diversions, 

groundwater contamination considerations, and accidental releases of radioactive liquid 

effluents in ground and surface water. 

SHINE PSAR, Section 2.4.11.2, “Pathways,” provides a particle flow analysis that only 

considers advective groundwater flow and predicts groundwater travel times and flow directions. 

Although the text does mention dispersivity (Section 2.4.11.3), the plume-spreading effects were 

not considered in the transport analysis. The staff concluded that without an understanding of 

the potential width of the contaminant plume, the analysis does not provide sufficient information 

to design a groundwater monitoring network (PSAR Chapter 11) or to evaluate the potential 

consequences of uncontrolled releases (PSAR Chapter 13). For instance, the potentiometric 

surfaces presented in SHINE PSAR Figure 2.4-4, “Simplified Groundwater Table Contours 

Based on Measured Groundwater Elevations in Monitoring Wells,” (Reference 45), suggests 

that any releases at the facility would flow undetected between Monitoring Wells SG-GW4A and 

SM-GW2A. Furthermore, the depth to bedrock may be as deep as 300 feet. Therefore, ample 

information must be presented regarding probable transport depths in order to allow the wells to 

be screened at the interval(s) most likely to detect potential releases. 

In RAI 2.4-1 (Reference 14), the staff requested that the applicant provide additional information 

and analysis on the spreading effects and transport depth of the contaminant plume for the 

design of the groundwater monitoring network presented in PSAR Chapter 11, and ensure that 

the dose limits for individual members of the public, as required by 10 CFR 20.1302(b), have 

been met.

In response to RAI 2.4-1 (Reference 20), the applicant provided information on the test wells 

and referred to the preliminary analysis of advective travel times in groundwater, as described in 

PSAR Section 2.4.11.2 and PSAR Table 2.4-13, “Summary of Parameters Used for Advective 

Travel Time Estimations.” The applicant indicated that there are no plausible liquid release 

pathways from the facility based on their analysis and, therefore, no liquid monitoring is required 

to meet the requirements of 10 CFR 20.1302. The applicant further stated that while no liquid

monitoring is required, it will voluntary conduct groundwater monitoring as part of the 

Community Environmental Monitoring Program to provide the public greater confidence in the 

operation of the plant. Additionally, the applicant stated that the requirements of 

10 CFR 20.1302 will be met as described in PSAR Section 11.1.7, “Environmental Monitoring.” 

The staff finds that the applicant’s response to RAI 2.4-1 provides the requested information 

and, therefore, is acceptable.
Site Characteristics

2-18

SHINE PSAR Table 2.4-13 (Section 2.4.11.2) presents the results of the analysis of 

groundwater travel times from the site to three offsite locations: (1) Rock River (West), (2) Rock 

River Tributary (Southwest), and (3) the nearest water supply well (MF461). The effective 

porosity for the expected case is 30 percent. The staff noted that the reference cited in the table 

for the porosity (Gaffield et al., 2002) indicates that a porosity of 20 percent is most 

representative of Rock County conditions. For example, a porosity of 20 percent would result in 

a travel time from the site to Rock River (West) of 6 years as opposed to 9 years presented in 

the table. 

In RAI 2.4-2 (Reference 14), the staff requested clarification regarding the porosity values used 

in the calculations. In response to RAI 2.4-2 (Reference 21), the applicant stated that the PSAR 

provides a range of porosity values from 10 percent to 30 percent. The 10 percent porosity 

value would provide the shortest groundwater travel time, while the 30 percent porosity value 

would provide the longest groundwater travel time. The applicant used the 10 percent porosity 

value to calculate the conservative advective travel times provided in PSAR Table 2.4-13. The

applicant also stated that, as described in PSAR Section 2.5.2.3, “Site Soil Conditions,” 20

percent effective porosity is not consistent with SHINE site conditions. Thus, the applicant used 

30 percent effective porosity for the expected advective travel time. The staff finds the response 

to RAI 2.4-2 sufficiently clarified the information in PSAR Table 2.4-13 and, therefore, is 

acceptable.

SHINE PSAR Table 2.4-13 (Section 2.4.11.2) presents the results of the travel time analysis. 

The staff noted that an arithmetic average of the hydraulic conductivities was used in the 

expected case calculations. Typically, hydraulic conductivities are represented in a log-normal 

distribution and geometric means are used to represent typical values. 

In RAI 2.4-3 (Reference 14), the staff asked for clarification regarding how hydraulic conductivity 

values were used and requested that the applicant provide the Advanced Aquifer Test Analysis 

Software (AQTESOLV) graphical output for the hydraulic conductivity calculations from the slug 

tests. 

In response to RAI 2.4-3, the applicant indicated that since the calculated arithmetic mean of the 

hydraulic conductivity values was found to be more conservative than the calculated geometric 

mean of the hydraulic conductivity values, “SHINE used the arithmetic mean of the hydraulic 

conductivity values to calculate the expected advective travel times provided in Table 2.4-13.” 

The applicant also clarified that the AQTESOLV graphical outputs for the hydraulic conductivity 

calculations from on-site slug tests were previously provided to the NRC as Appendix F of the 

Preliminary Hydrological Analyses for the Janesville, Wisconsin site, provided as Attachment 23 

to the SHINE Response to Environmental Requests for Additional Information (Reference 31). 

The staff finds that the applicant’s response to RAI 2.4-3 sufficiently clarified the information in 

PSAR Table 2.4-13 and, therefore, is acceptable.

SHINE PSAR Section 2.4.11.2 indicates that travel times through the unsaturated zone had not 

been considered due to the limited information available. The staff noted that an estimation of 

potential lag times through the unsaturated zone, following a release, is important with respect 

to evaluating accident scenarios and designing monitoring frequencies and remedial options.

In RAI 2.4-4 (Reference 14), the staff requested that the applicant provide additional information 

on the bounding estimates for travel time through the unsaturated zone. 
Site Characteristics

2-19

In response to RAI 2.4-4 (Reference 21), the applicant stated that it determined bounding 

estimates for travel time through the unsaturated zone, or vadose zone, based on the estimated 

travel distance (thickness) of the vadose zone and the estimated velocity of groundwater travel 

through the vadose zone. For vertical flow, the travel distance is calculated as the thickness of 

the vadose zone (provided in RAI 2.4-4, Table 2.4-4-1). The applicant used a representative 

vadose zone thickness of 50 feet (15 m). A lower bound vadose zone thickness was estimated 

as 44 ft (13 m), while an upper bound vadose zone thickness was estimated as 71 feet (21 m). 

Bounding estimates for travel time through the vadose zone are provided in the response to 

RAI 2.4-4, Table 2.4-4-2. The staff finds that the applicant’s response to RAI 2.4-4 provides the 

requested information and, therefore, is acceptable.

NUREG-1537, Part 1, Chapter 2 states, in part, “the applicant should discuss and describe the 

...hydrological... characteristics of the site and vicinity in conjunction with present and projected 

population distributions, industrial facilities and land use, and site activities and controls.” 

SHINE PSAR Section 2.4.1.2, “General Setting – Groundwater,” mentions that there are 

irrigation wells operated on properties in the vicinity that have the potential to influence 

groundwater levels. The staff noted that these irrigation wells could also act as pathways for 

bringing any groundwater contamination released by the facility to the surface. The pumping of 

irrigation wells can also have a significant effect on groundwater flow directions.

In RAI 2.4-5 (Reference 14), the staff requested that SHINE provide additional information on 

irrigation well location(s) and its construction and operating parameters. 

In response to RAI 2.4-5 (Reference 21), the applicant provides a list of well construction 

reports and groundwater flow direction for both pumped and non-pumped conditions. 

Consequently, it is not anticipated that withdrawals from wells within an 8-km (5-mi) radius 

would change the flow direction of groundwater on the proposed SHINE site. The applicant 

determined the well with the lowest pumping head was closest to the proposed site. The 

applicant calculated the advective travel times for this well to be 0.1 years (expected 

permeability and porosity assumptions) and 0.01 years (conservative permeability and porosity 

assumptions). The staff finds that the applicant’s response to RAI 2.4-5 provides the requested 

information and, therefore, is acceptable.

On the basis of its review, the staff has determined that the level of detail and analyses provided 

in SHINE PSAR Section 2.4 demonstrates an adequate design basis and satisfies the 

applicable acceptance criteria of NUREG-1537, Part 2, Section 2.4, which allows the staff to find

the following: 

(1) The applicant considered hydrologic events of credible frequency and consequence in 

selecting the facility site. The site is not located where catastrophic hydrologic events 

are credible.

(2) The applicant considered credible hydrologic events in developing the design bases 

for the facility, to mitigate or avoid significant damage so that safe operation and 

shutdown of the facility would not be precluded by a hydrologic event.

(3) The applicant selected combinations of site characteristics and facility design bases to 

provide reasonable assurance that uncontrolled release of radioactive material in the 

event of a credible hydrologic occurrence would be bounded by accidents analyzed in 

PSAR Chapter 13.
Site Characteristics

2-20

(4) The facility design bases give reasonable assurance that contamination of ground and 

surface waters at the site from inadvertent release or leakage of primary coolant, 

neutron activation, or airborne releases would not exceed applicable limits of 

10 CFR Part 20, “Standards for Protection Against Radiation.”

Based on SHINE PSAR Section 2.4, as supplemented by the applicant’s responses to RAIs, the 

staff finds that the applicant’s description of general, local, and site hydrology sufficient and 

meets the applicable regulatory requirements and guidance for the issuance of a construction 

permit in accordance with 10 CFR 50.35.

Geology, Seismology, and Geotechnical Engineering

The staff evaluated the sufficiency of SHINE’s geology, seismology, and geotechnical 

characteristics for its proposed site, as described in SHINE PSAR Section 2.5 using the 

guidance and acceptance criteria from Section 2.5, “Geology, Seismology, and Geotechnical 

Engineering,” of NUREG-1537, Part 2.

Consistent with the review procedures of the NUREG-1537, Part 2, Section 2.5, the staff 

confirmed that the information presented in the SHINE PSAR was obtained from sources of 

adequate credibility and is consistent with other available data, such as data from the 

U.S. Geological Survey (USGS) or in the FSAR of a nearby nuclear power plant. The staff also 

evaluated whether there is reasonable assurance that the seismic characteristics of the site are 

considered in the design bases of structures, systems, and other facility features discussed in 

PSAR Chapter 3, “Design of Structures, Systems, and Components.”

NUREG-1537, Part 1, Section 2.5 states, in part, that “the applicant should detail the seismic 

and geologic characteristics of the [proposed] site and the region surrounding the site. The 

degree of detail and extent of the considerations should be commensurate with the potential 

consequences of seismological disturbance, both to the facility and to the public from 

radioactive releases.”

In SHINE PSAR Section 2.5, the applicant provided descriptions on the regional geologic 

features, the site-specific geologic features, the historical seismic information, the maximum 

earthquake potential, how vibratory ground motion was addressed, the surface faults in the 

region, and the liquefaction potential. 

The regulations in 10 CFR Part 100, Appendix A, “Seismic and Geologic Siting Criteria for 

Nuclear Power Plants,” defines a capable fault as a fault with “[m]ovement at or near the ground 

surface at least once within the past 35,000 years or movement of a recurring nature within the 

past 500,000 years.” Using this definition of capable fault, SHINE PSAR Section 2.5.1.4, 

“Structural Geology,” provides a discussion of 17 major faults and folds in Wisconsin and the six 

surrounding states, and based on lack of evidence for Pleistocene or post-Pleistocene 

displacement, concludes that all but one are not capable. 

In RAI 2.5-1 (Reference 14), the staff requested that the applicant provide additional information 

explaining the basis for the determination that there are no capable faults, and provide 

additional information with respect to the recurring nature of the faults. 

In response to RAI 2.5-1 (Reference 21), the applicant clarified its determination that, with the 

exception of the Wabash Valley liquefaction features, the faults within 322 km (200 mi) show no 
Site Characteristics

2-21

evidence of being capable faults and provided published scientific information to justify this 

claim.

The applicant stated in PSAR Section 2.5.1, that the only capable fault in the Wabash Valley 

liquefaction features region is located approximately 273 km (170 mi) south of the site. At least 

seven Holocene earthquakes and one late Pleistocene earthquake may have generated on the 

order of M 7.5 earthquakes. The applicant’s RAI 2.5-1 response stated that the Wabash Valley

liquefaction features “appear to have originated from earthquakes centered in southern Indiana 

and Illinois, more than 200 miles from the SHINE site.” The staff finds that the applicant’s 

response to RAI 2.5-1 provides the information requested and, therefore, is acceptable.

SHINE PSAR, Section 2.5.1.4.6, “Saint Charles Lineament (SCL),” states, in part, “[s]ince 1974, 

seven earthquakes of magnitude 2.5 or less have been recorded in regions surrounding the 

SCL.” The staff noted that information pertaining to these earthquakes is not provided in the 

summary tables. 

In RAI 2.5-2, (Reference 14), the staff requested that the applicant provide additional 

information regarding seven earthquakes that occurred near the Saint Charles Lineament SCL. 

In response to RAI 2.5-2 (Reference 21), the applicant stated that none of these seven 

earthquakes are listed in the composite earthquake catalog developed for the Central and 

Eastern United States Seismic Source Characterization for Nuclear Facilities (CEUS-SSC) 

Project (Reference 105). Since the seven earthquakes are not in the CEUS-SSC catalog, the 

applicant considered them not of a large enough magnitude or well enough located to indicate 

neotectonic activity along the SCL. Additionally, the applicant determined, based on a 

re-evaluation, that the seven referenced earthquakes do not suggest ongoing activity on the 

SCL, and should not be listed in PSAR Table 2.5-1, “Historic Earthquake Epicenters Located 

Within Approximately 200 Miles (322 km) of the SHINE Site.” Additionally, because there is no 

evidence that any of these earthquakes were felt, SHINE did not include them in PSAR 

Table 2.5-3, “Recorded Earthquake Intensities (Modified Mercalli Intensity – MMI) for 

Earthquakes Within Approximately 200 Miles (322 km) of the SHINE Site.” The staff finds that 

the applicant’s response to RAI 2.5-2 provided the requested additional information and, 

therefore, is acceptable.

SHINE PSAR Section 2.5.2.2, “Structural Geology,” states, in part, “[d]espite the presence of 

the Arch, cross sections from Mudrey et al. (1982), suggest that the Cambrian and Ordovician 

sedimentary rock units beneath the SHINE site probably have very shallow to horizontal dips.

These observations indicate little or no net deformation beneath the SHINE site over about the 

last 500 million years.” The staff’s review of the Bedrock Geology of Wisconsin map referenced 

in the PSAR (Mudrey et al., 1982), failed to locate the cross-sections being referenced in the 

text. 

In RAI 2.5-3 (Reference 14), the staff requested additional information on the cross sections 

associated with Bedrock Geology of Wisconsin in the document referenced in SHINE PSAR 

Section 2.5.2.2. 

In its response (Reference 20), the applicant provided the web link referenced in the document 

(see Reference 46). The staff finds that the applicant’s response to RAI 2.5-3 provided a 

sufficient reference to the requested document and, therefore, is acceptable.

SHINE PSAR Section 2.5.3.1, “Historic Earthquakes,” provides a list of databases and 

references that were used to identify historic earthquakes at the location of the SHINE facility. 
Site Characteristics

2-22

The staff noted that the most recent historic earthquake located within approximately 200 miles

of the SHINE site was in 1985 (PSAR Table 2.5-1, page 2.5-26). Another database that 

includes six more recent earthquakes is compiled by the USGS at 

http://earthquake.usgs.gov/earthquakes. 

In RAI 2.5-4 (Reference 14), the staff requested that the applicant provide additional information 

justifying the exclusion of the earthquake information compiled by the USGS from analysis in 

the PSAR, or provide a reanalysis that takes this information into consideration in the PSAR. 

In response to RAI 2.5-4 (Reference 21), the applicant stated that it relied on the analysis of 

earthquake records used to create the comprehensive earthquake catalog for the CEUS-SSC 

project. Therefore, while the USGS-hosted database includes six post-1985 earthquake 

epicenters, SHINE included only those earthquakes that have passed the robust screening 

process used to prepare the CEUS-SSC catalog in PSAR Table 2.5-1. The staff finds that the 

applicant’s response to RAI 2.5-4 described the bases for the exclusion of the USGS 

earthquake information and, therefore, is acceptable.

NUREG-1537, Part 1, Section 2.5.1, “Regional Geology,” states, in part, “[t]he applicant should 

discuss all geologic and seismic hazards within the region that could affect the facility....” 

SHINE PSAR Section 2.5.2.4, “Non-Seismic Geological Hazards,” states, in part, that “Rock 

County contains carbonate bedrock susceptible to dissolution or karst formation [Reference 

46].” The staff noted that the Rock County Hazard Mitigation Plan indicates that no significant 

sinkholes have been reported in Rock County in recent years. The plan indicates a potential for 

karst features to form in the county, particularly in the eastern third of the county that lies to the 

east of the SHINE site. 

In RAI 2.5-5 (Reference 14), the NRC staff requested that the applicant provide additional 

information regarding regional magnetic and gravity geophysical anomalies to include an 

evaluation of potential karst features at the SHINE site. 

In response to RAI 2.5-5 (Reference 21), the applicant provided two figures which provide 

details of the composite aeromagnetic and Bouguer gravity anomalies in southern Wisconsin. 

The applicant stated that from these figures, the available regional magnetic and Bouguer 

gravity anomalies in southern Wisconsin are suitable only for identifying the major regional fault 

structures with large vertical separations. Regarding sink holes, the applicant stated that small 

sinkholes in parts of Rock County have been reported but not at the proposed site. Because of 

the near-surface geology, the applicant stated that it is very unlikely that a sinkhole would form 

near the SHINE site. The SHINE site has little topographic relief and lacks any geomorphic 

evidence of differential subsidence that may indicate past or ongoing solution of any subsurface 

carbonate rocks and formation of karst features. The staff finds the applicant’s response to 

RAI 2.5-5 provided the requested information and, therefore, is acceptable.

NUREG-1537, Part 1, Section 2.5.7, “Liquefaction Potential,” states that the applicant should 

discuss soil structure. SHINE PSAR Section 2.5.7.1, “Site Soil Conditions,” states that 

geotechnical engineering field investigations were conducted that included standard 

penetrometer test (SPT) blow counts (N-values) measured in 14 boreholes. The staff noted 

that, however, details and an explanation were not given about how and whether these 

investigations were used to develop the soil parameters (engineering properties) listed in SHINE 

PSAR Chapter 3 (Section 3.4.2.6.3.1). 
Site Characteristics

2-23

In RAI 2.5-6 (Reference 14), the staff requested that the applicant provide a report with details 

and results from the geotechnical investigations. 

In response to RAI 2.5-6 (Reference 21), the applicant stated that the Preliminary Geotechnical 

Engineering Report for the SHINE site was previously provided to the NRC as Attachment 26 to 

the SHINE Response to Environmental RAI. The applicant also stated that soil parameters in 

FSAR Section 3.4.2.6.3.1 will be revised to more accurately reflect the results documented in 

the Preliminary Geotechnical Engineering Report. The staff finds the applicant’s response to 

RAI 2.5-6 with a commitment to update the FSAR to accurately and consistently reflect the 

Preliminary Geotechnical Engineering Report acceptable.

On the basis of its review, the staff has determined that the level of detail and analyses provided 

in SHINE PSAR Section 2.5 demonstrates an adequate design basis and satisfies the 

applicable acceptance criteria of NUREG-1537, Part 2, Section 2.5, allowing the staff to find the 

following:

(1) The information on the geologic features and the potential seismic activity at the site 

has been provided in sufficient detail and in a form to be integrated acceptably into the 

design bases for structures, systems, and operating characteristics of the facility.

(2) The information in the PSAR indicates that damaging seismic activity at the proposed 

site during its projected lifetime is very unlikely. Furthermore, if seismic activity were to 

occur, any radiologic consequences are bounded or analyzed in PSAR Chapter 13.

(3) The PSAR shows that there is no significant likelihood that the public would be subject 

to undue radiological risk following seismic activity, therefore, the potential for 

earthquakes does not make the site unsuitable for the proposed facility.

Based on SHINE PSAR Section 2.5, as supplemented by the applicant’s responses to RAIs, the 

staff finds that the applicant’s description of geology, seismology, and geotechnical 

characteristics sufficient and meets the applicable regulatory requirements and guidance for the 

issuance of a construction permit in accordance with 10 CFR 50.35.

Summary and Conclusions

The staff evaluated the descriptions and discussions of the SHINE facility site characteristics, as 

described in Chapter 2 of the SHINE PSAR and supplemented by the applicant’s responses to 

RAIs, and finds that the SHINE facility site characteristics: (1) provide reasonable assurance 

that the final design will conform to the design basis, and (2) meet all applicable regulatory 

requirements and acceptance criteria in NUREG-1537. Based on these findings, the staff has 

made the following conclusions for the issuance of a construction permit in accordance with 

10 CFR 50.35:

(1) SHINE has described the proposed design of the facility, including, but not limited to, 

the principal architectural and engineering criteria for the design, and has identified the 

major features or components incorporated therein for the protection of the health and 

safety of the public.

(2) Such further technical or design information as may be required to complete the safety 

analysis, and which can reasonably be left for later consideration, will be supplied in 

the FSAR.
Site Characteristics

2-24

(3) There is reasonable assurance that, taking into consideration the site criteria contained 

in 10 CFR Part 100, the proposed facility can be constructed and operated at the 

proposed location without undue risk to the health and safety of the public.
3-1

DESIGN OF STRUCTURES, SYSTEMS, AND COMPONENTS

The purpose of structures, systems, and components (SSCs) is to ensure safety of the SHINE 

Medical Technologies, Inc. (SHINE or the applicant) irradiation facility (IF) and radioisotope 

production facility (RPF) and protection of the public. The material presented in this chapter of 

the SHINE Preliminary Safety Analysis Report (PSAR) should emphasize the safety and 

protective functions and related design features that help provide defense in depth against 

uncontrolled release of radioactive material. The bases for the design criteria for some of the 

systems discussed in this chapter may be developed in other chapters of the PSAR.

This chapter of the SHINE construction permit safety evaluation report (SER) describes the 

review and evaluation of the U.S. Nuclear Regulatory Commission (NRC) staff (the staff) of the 

preliminary design of the SHINE IF and RPF SSCs as presented in Chapter 3, “Design of 

Structures, Systems, and Components,” of the SHINE PSAR, as supplemented by the 

applicant’s responses to requests for additional information (RAIs).

Areas of Review

SHINE PSAR Chapter 3 identifies the SSCs considered to ensure facility safety and protection 

of the public. SHINE PSAR Sections 3.1, “Design Criteria,” through 3.5, “Systems and 

Components,” are applicable to both the SHINE IF and RPF. The SSCs that are unique to 

either the IF or RPF are covered in SHINE PSAR Sections 3.5a, “Irradiation Facility,” or 3.5b, 

“Radioisotope Production Facility,” respectively. 

The staff reviewed SHINE PSAR Chapter 3 against applicable regulatory requirements using 

appropriate regulatory guidance and standards to assess the sufficiency of the preliminary 

design criteria of the SHINE facility SSCs. As part of this review, the staff evaluated 

descriptions and discussions of the SHINE facility SSCs, with special attention to design and 

operating characteristics, unusual or novel design features, and principal safety considerations. 

The preliminary design of the SHINE facility SSCs was evaluated to ensure the design criteria; 

design bases; and information relative to materials of construction, general arrangement, and 

approximate dimensions are sufficient to provide reasonable assurance that the final design will 

conform to the design basis. In addition, the staff reviewed SHINE’s identification and 

justification for the selection of those variables, conditions, or other items which are determined 

to be probable subjects of technical specifications for the facility, with special attention given to 

those items that may significantly influence the final design.

Areas of review for this chapter included both SHINE IF and RPF SSCs. Within these review 

areas, the staff assessed the capability of the SSCs to ensure safe facility operation, safe facility 

shutdown and continued safe conditions, response to anticipated transients, response to 

potential accidents analyzed in PSAR Chapter 13, “Accident Analysis,” and control of 

radioactive material discussed in PSAR Chapter 11, “Radiation Protection Program and Waste 

Management.”
Design of Structures, Systems, and Components

3-2

Summary of Application

SHINE PSAR Chapter 3 describes the design bases of SSCs for the IF and RPF established to 

ensure facility safety and protection of the public. With the exception of discussion related to 

IF- or RPF-specific systems, the summary provided below applies to both the IF and RPF.

SHINE PSAR Section 3.1 discusses the use of defense-in-depth practices in the SHINE facility 

and system design. PSAR Section 3.1 also discusses the facility and provides a “road map” 

where the specifics of the design criteria are discussed in detail. PSAR Section 3.2, 

“Meteorological Damage,” includes historical data and predictions as specified in PSAR 

Chapter 2, “Site Characteristics,” and discusses the criteria used to design the SHINE facility to 

withstand wind, tornado, snow and ice, and water damage. The combinations of the 

meteorological loads with other loads (i.e., dead loads and earthquake loads) for the structural 

analysis are provided in PSAR Section 3.4, “Seismic Damage.” PSAR Section 3.3, “Water 

Damage,” provides information on the hydrological conditions found at the facility. PSAR 

Sections 3.4.1, “Seismic Input,” and 3.4.2, “Seismic Analysis of Facility Structures,” provide 

information on seismic input and analysis, including the following items: design response 

spectra, design time histories, critical damping values, seismic analysis methods, soil-structure 

interaction analysis (includes meteorological loads), combination of earthquake components, 

seismic analysis results, assessment of structural seismic stability (includes meteorological 

loads), and structural analysis of facility (includes meteorological loads). PSAR Section 3.4.3, 

“Seismic Qualification of Subsystems and Equipment,” presents the seismic qualification of the 

SHINE facility’s systems and equipment. PSAR Section 3.4.4, “Seismic Instrumentation,” 

discusses SHINE’s seismic instrumentation. PSAR Section 3.4.5.1, “Aircraft Impact Analysis,” 

provides an aircraft impact analysis since the SHINE facility is located near the Southern 

Wisconsin Regional Airport (SWRA). PSAR Section 3.4.5.2, “External Explosions,” provides an 

assessment of external explosions. PSAR Section 3.5, “Systems and Components,” discusses 

SSCs and the criteria used to determine if SSCs are considered safety-related or 

non-safety-related. Additionally, SSCs were classified by three seismic categories (i.e., Seismic 

Category I, Seismic Category II, and Seismic Category III) and two quality levels (i.e., QL-1 and 

QL-2). Safety- related SSCs are classified QL-1 and Seismic Category I; and non-safety-related 

SSCs are classified QL-2 and either Seismic Category II or Seismic Category III. PSAR 

Sections 3.5a, “Irradiation Facility,” and 3.5b, “Radioisotope Production Facility,” lists systems 

that are part of the IF and RPF, respectively. Specifically, SSCs required to operate during 

and/or after design-basis accidents or a design-basis earthquake are discussed in these 

sections or in the system’s PSAR section and include relevant requirements, standards, and 

documentation. 

Additionally, the following SHINE PSAR tables list facility systems and provide references to 

guidance, codes, and standards.

• Table 3.1-1, “Systems List.” 

• Table 3.1-2, “Codes and Standards Used to Guide the Design of the SHINE Facility.” 

• Table 3.1-3, “NRC Guidance Used in the Design of the SHINE Facility.”

Regulatory Basis and Acceptance Criteria

The staff reviewed SHINE PSAR Chapter 3 against applicable regulatory requirements, using 

appropriate regulatory guidance and standards, to assess the sufficiency of the preliminary 

design criteria for the SHINE facility SSCs for the issuance of a construction permit. In 
Design of Structures, Systems, and Components

3-3

accordance with paragraph (a) of 10 CFR 50.35, “Issuance of Construction Permits,” a 

construction permit authorizing SHINE to proceed with construction may be issued once the 

following findings have been made:

(1) SHINE has described the proposed design of the facility, including, but not limited to, 

the principal architectural and engineering criteria for the design, and has identified the 

major features or components incorporated therein for the protection of the health and 

safety of the public.

(2) Such further technical or design information as may be required to complete the safety 

analysis, and which can reasonably be left for later consideration, will be supplied in 

the final safety analysis report (FSAR).

(3) Safety features or components, if any, which require research and development have 

been described by SHINE and a research and development program will be conducted 

that is reasonably designed to resolve any safety questions associated with such 

features or components.

(4) On the basis of the foregoing, there is reasonable assurance that: (i) such safety 

questions will be satisfactorily resolved at or before the latest date stated in the 

application for completion of construction of the proposed facility, and (ii) taking into 

consideration the site criteria contained in 10 CFR Part 100, “Reactor Site Criteria,” the 

proposed facility can be constructed and operated at the proposed location without 

undue risk to the health and safety of the public.

With respect to the last of these findings, the staff notes that the requirements of

10 CFR Part 100 are specific to nuclear power reactors, and therefore not applicable to the 

SHINE facility. However, the staff evaluated SHINE’s site specific conditions using site criteria 

similar to 10 CFR Part 100, by using the guidance in NUREG-1537, Part 1, “Guidelines for 

Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Format and 

Content,” issued February 1996 (Reference 4) 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 (Reference 5). The staff’s review 

evaluated the geography and demography of the site; nearby industrial, transportation, and 

military facilities; site meteorology; site hydrology; and site geology, seismology, and 

geotechnical engineering to ensure that issuance of the construction permit will not be inimical 

to public health and safety. The staff also evaluated structures, components, equipment, and 

systems designed to ensure safe operation, performance, and shutdown when subjected to 

extreme weather, floods, seismic events, missiles (including aircraft impacts), chemical and 

radiological releases, and loss of offsite power.

The staff’s evaluation of the preliminary design criteria for SHINE’s SSCs does not constitute 

approval of the safety of any design feature or specification. Such approval will be made 

following the evaluation of the final design of the SHINE facility SSCs as described in the FSAR 

as part of SHINE’s operating license application.
Design of Structures, Systems, and Components

3-4

Applicable Regulatory Requirements

The applicable regulatory requirements for the evaluation of SHINE’s SSC design criteria are as 

follows:

10 CFR 50.34, “Contents of applications; technical information,” paragraph (a), 

“Preliminary safety analysis report.”

10 CFR 50.40, “Common standards.”

Regulatory Guidance and Acceptance Criteria

In applying guidance and acceptance criteria, the staff used its judgment as to which 

acceptance criteria were relevant to SHINE’s proposed facility, as much of this guidance was 

originally developed for nuclear reactors. Given the similarities in SHINE’s proposed facility and 

non-power research reactors, the staff used established guidance documents and the 

Commission’s regulations to determine the acceptance criteria for demonstrating compliance 

with 10 CFR regulatory requirements. For example, the staff used: 

• NUREG-1537, Part 1, “Guidelines for Preparing and Reviewing Applications for the 

Licensing of Non-Power Reactors, Format and Content,” issued February 1996 

(Reference 4).

• 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 (Reference 5). 

• “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 (Reference 6).

• “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 (Reference 7).

As stated in the ISG Augmenting NUREG-1537, the staff determined that certain guidance 

originally developed for heterogeneous non-power research and test reactors is applicable to 

aqueous homogenous facilities and production facilities. SHINE used this guidance to inform 

the design of its facility and prepare its PSAR. The staff’s use of reactor-based guidance in its 

evaluation of the SHINE PSAR is consistent with the ISG Augmenting NUREG-1537.

As appropriate, additional guidance (e.g., NRC regulatory guides, Institute of Electrical and 

Electronics Engineers (IEEE) standards, American National Standards Institute/American 

Nuclear Society (ANSI/ANS) standards) has been used in the staff’s review of SHINE’s PSAR. 

The use of additional guidance is based on the technical judgment of the reviewer, as well as 

references in NUREG-1537, Parts 1 and 2; the ISG Augmenting NUREG-1537, Parts 1 and 2; 

and the SHINE PSAR. Additional guidance documents used to evaluate SHINE’s PSAR are 

provided as references in Appendix B, “References,” of this SER.
Design of Structures, Systems, and Components

3-5

Review Procedures, Technical Evaluation, and Evaluation Findings

SHINE PSAR Chapter 3 describes the design bases of SSCs for the IF and RPF established to 

ensure facility safety and protection of the public. The technical evaluations provided in 

Sections 3.4.1 through 3.4.4 apply to both the SHINE IF and RPF; Section 3.4.5.1 applies to the 

SHINE IF; and Section 3.4.5.2 applies to the SHINE RPF. The staff’s evaluations consider the 

interface of SSCs between the IF and RPF as part of the technical evaluation.

The staff performed an evaluation of the technical information presented in SHINE PSAR 

Chapter 3, as supplemented by the applicant’s responses to RAIs. The purpose of the review 

was to assess the sufficiency of the preliminary design and performance of the SHINE facility’s 

SSC design criteria for the issuance of a construction permit, in accordance with 

10 CFR 50.35(a). Sufficiency of the preliminary design criteria for SHINE’s SSCs is determined 

by ensuring the design meets applicable regulatory requirements, guidance, and acceptance 

criteria, as discussed in Section 3.3, “Regulatory Basis and Acceptance Criteria,” of this SER. A 

summary of the technical evaluation is SER Section 3.5, “Summary and Conclusion.”

For the purposes of issuing a construction permit, the preliminary design of the SHINE facility 

SSCs may be adequately described at a functional or conceptual level. The staff evaluated the 

sufficiency of the preliminary design of the SHINE facility SSCs based on the applicant’s design 

methodology and ability to provide reasonable assurance that the final design will conform to 

the design bases with adequate margin for safety. As such, the staff’s evaluation of the 

preliminary design of the SHINE facility SSCs does not constitute approval of the safety of any 

design feature or specification. Such approval will be made following the evaluation of the final 

design of the SHINE facility SSCs, as described in the FSAR, as part of SHINE’s operating 

license application.

Design Criteria

The staff evaluated the sufficiency of the design criteria, as described in SHINE PSAR 

Section 3.1 using the guidance and acceptance criteria from Section 3.1, “Design Criteria,” of 

NUREG-1537, Parts 1 and 2.

Consistent with the review procedures of NUREG-1537, Part 2, Section 3.1, the staff compared 

the specified design criteria with the proposed normal operation of the SHINE facility, response 

to anticipated transients, and consequences of accident conditions applicable to the appropriate 

SSCs assumed to function in SHINE PSAR Section 3.1 and other relevant chapters of the 

PSAR.

Section 3.1 of NUREG-1537, Part 2, states that the design criteria should be specified for each 

SSC that is assumed in the PSAR to perform an operational or safety function. Additionally, 

design criteria should include references to applicable up-to-date standards, guides, and codes. 

The design criteria for SSCs should be stipulated as outlined below:

• Design for the complete range of normal facility operating conditions.

• Design to cope with anticipated transients and potential accidents.
Design of Structures, Systems, and Components

3-6

• Design with redundancy to protect against unsafe conditions in case of single failures of 

facility protective and safety systems.

• Design to facilitate inspection, testing, and maintenance.

• Design to limit the likelihood and consequences of fires, explosions, and other potential 

manmade conditions.

• Design with quality standards commensurate with the safety function and potential risks.

• Design bases to withstand or mitigate wind, water, and seismic damage to reactor 

systems and structures.

• Design includes analysis of function, reliability, and maintainability of systems and 

components.

In addition, the applicant should identify the structures, systems, and components by 

function(s), modes of operation, location, type(s) of actuation, relative importance in the control 

of radioactive material and radiation, applicable design criteria, and the chapter and section in 

the PSAR where these design criteria are applied to the specific structure, system, or 

component.

SHINE PSAR Section 3.1 states the SHINE facility and system design are based on 

defense-in-depth practices. Defense-in-depth practices means a design philosophy, applied 

from the outset and through completion of the design, that is based on providing successive 

levels of protection such that health and safety will not be wholly dependent upon any single 

element of the design, construction, maintenance, or operation of the facility. The net effect of 

incorporating defense-in-depth practices is a conservatively designed facility and system that 

will exhibit greater tolerance to failures and external challenges. PSAR Section 3.1 also 

provides sufficient information to guide the staff to the appropriate section of the PSAR where 

the design criteria for specific SSCs are discussed in detail. Additionally, PSAR Section 3.1 

outlines the standards, guides, and codes applied to the design of the SSCs.

On the basis of its review, the staff has determined that the level of detail provided in SHINE 

PSAR Section 3.1 demonstrates SHINE has established adequate design criteria for its 

preliminary design and satisfies the applicable acceptance criteria of NUREG-1537, Part 2, 

Section 3.1. The staff concludes: (1) the design criteria are based on applicable standards, 

guides, codes, and criteria and provide reasonable assurance that the facility SSCs can be built 

and will function as designed and as required by the PSAR; and (2) the design criteria provide 

reasonable assurance that the public will be protected from radiological risks from operation. 

Therefore, the staff finds that the design criteria of the SHINE facility SSCs meet the applicable 

regulatory requirements for the issuance of a construction permit in accordance with 

10 CFR 50.35. Further technical or design information required to complete the safety analysis 

may reasonably be left for later consideration. The staff will confirm that the final design 

conforms to this design basis during the evaluation of SHINE’s FSAR.
Design of Structures, Systems, and Components

3-7

Meteorological Damage

The staff evaluated the sufficiency of the facility design features to cope with wind or other 

meteorological damage, as described in SHINE PSAR Section 3.2 using the guidance and 

acceptance criteria from Section 3.2, “Meteorological Damage,” of NUREG-1537, Part 2.

Consistent with the review procedures of NUREG-1537, Part 2, Section 3.2, the staff considered 

the description of the site meteorology to ensure that all SSCs that could suffer meteorological 

damage are considered, as presented in SHINE PSAR Section 3.2 and other relevant chapters 

of the PSAR. The design criteria are compatible with local architectural and building codes for 

similar structures. The design specifications for SSCs are compatible with the functional 

requirements and capability to retain function throughout the predicted meteorological 

conditions. The methods for determining the wind, tornado, and snow and ice loadings are 

summarized. In PSAR Section 3.4.2.6.3, “Site Design Parameters,” these loads are provided as 

site design parameters rather than as structural design loads. The combinations of the 

meteorological loads with other loads (i.e., dead loads and earthquake loads) for the structural 

analysis are provided in PSAR Section 3.4.

NUREG-1537, Part 1, Section 2.3.1, “General and Local Climate,” states, in part, “[t]he applicant 

should also estimate the weight of the 100-year return period snowpack and the weight of the 

48-hour probable maximum precipitation for the site vicinity, if applicable, as specified by the 

USGS [U.S. Geological Survey]. Using these estimates for Chapter 3, the applicant should 

calculate the design loads on the roof of the building containing the IF and the RPF, and 

compare them with local building codes for similar types of structures.” 

While SHINE PSAR Section 2.3.1.2.9, “Snowpack and Probably Maximum Precipitation (PMP),” 

contains an estimate of the snowpack load and probable maximum precipitation, as described in 

NUREG-1537, the information developed in PSAR Section 2.3.1.2.9 was not used to calculate 

the design loads described in PSAR Section 3.2.3, “Snow, Ice, and Rain Loading.” Therefore, 

in RAI 3.2-1 (Reference 14), the staff asked the applicant to estimate the weight of the 100-year 

return period snowpack and the weight of the 48-hour probable maximum precipitation for the 

site vicinity, if applicable, as specified by the USGS. The staff asked the applicant to calculate 

the design loads on the roof of the building containing the IF and the RPF and compare them 

with local building codes for similar types of structures. The applicant was also asked to provide 

additional information explaining why PSAR Section 3.2.3 does not utilize the snowpack and 

probably maximum precipitation data developed under PSAR Section 2.3.1.2.9 or update PSAR 

Section 3.2.3 with the data in PSAR Section 2.3.1.2.9, accordingly.

In response to RAI 3.2-1 (Reference 21), the applicant identified the location of this information 

in the PSAR and stated that a rain-on-snow surcharge load is not considered in the structural 

analysis because the SHINE facility is located in an area where the ground snow load 

(determined from Figure 7-1 of American Society of Civil Engineers [ASCE] 7-05, “Minimum 

Design Loads for Buildings and Other Structures”) is greater than 20 pounds per square foot 

(lb/ft2

). The applicant also stated that PSAR Sections 2.3.1.2.9 and 19.3.2.3.6, “Snowpack and 

Probable Maximum Precipitation (PMP),” contain an administrative error stating the units for the 

50- and 100-year interval snowpacks are inches. Consistent with Figure 7-1 of ASCE 7-05, the 

units for the 50- and 100-year interval snowpacks are lb/ft2

. SHINE has updated its PSAR to 

resolve this error.

The staff finds this response is consistent with local building codes and industry standard and, 

therefore, satisfies the acceptance criteria of NUREG-1537, Part 2, Section 3.2, and 
Design of Structures, Systems, and Components

3-8

demonstrates an adequate methodology for a preliminary design. The staff will confirm that the 

final design conforms to this design basis during the evaluation of SHINE’s FSAR.

On the basis of its review, the staff has determined that the level of detail provided on 

meteorological damage is adequate and supports the preliminary design and satisfies the 

applicable acceptance criteria of NUREG-1537, Part 2, Section 3.2. The staff concludes: 

(1) the design criteria and designs provide reasonable assurance that SSCs would continue to 

perform their safety functions as specified in the PSAR under potential meteorological damage 

conditions; and (2) the design criteria and designs use local building codes, standards, or other 

applicable criteria to ensure that significant meteorological damage at the facility site is very 

unlikely.

Therefore, the staff finds that the SHINE facility design features for coping with meteorological 

damage are sufficient and meet the applicable regulatory requirements for issuance of a 

construction permit in accordance with 10 CFR 50.35. Further technical or design information 

required to complete the safety analysis may reasonably be left for later consideration. The 

staff will confirm that the final design conforms to this design basis during the evaluation of 

SHINE’s FSAR.

Water Damage

The staff evaluated the sufficiency of the facility design features to cope with predicted 

hydrological conditions, as described in SHINE PSAR Section 3.3 using the guidance and 

acceptance criteria from Section 3.3, “Water Damage,” of NUREG-1537, Part 2.

Consistent with the review procedures of Section 3.3 of NUREG-1537, Part 2, the staff 

considered the site description to ensure that all safety-related SSCs with the potential for 

hydrological (water) damage, including the damage due to a potential inadvertent fire protection 

system (FPS) discharge, are considered in this PSAR section. For any such safety-related 

SSC, the staff reviewed the design bases to verify consequences are addressed and described 

in detail in appropriate chapters of the SHINE PSAR.

SHINE PSAR Section 3.3 provides the design-basis precipitation level (at grade), flood level 

(below grade), and maximum ground water level (below grade) for the SHINE facility. These 

levels are associated with the local probable maximum precipitation (PMP) and the local 

probable maximum flood (PMF) and are quantified in PSAR Section 2.4, “Hydrology.” PSAR 

Section 2.4.2.3, “Effect of Local Intense Precipitation,” states that a local PMP event creates a 

water level about level with grade. The first floor of the building is at least 4 inches (in.) above 

grade; therefore, water will not infiltrate the door openings in the case of a local PMP event. In 

PSAR Section 2.4.3, “Probable Maximum Flood on Streams and Rivers,” SHINE estimates a 

local PMF event creates a water level approximately 50 feet (ft) (15.2 meters [m]) below grade. 

The lowest point of the facility is 29 ft (8.8 m) below grade; therefore, flooding would not cause 

any structural loading in the case of a local PMF event. There is no dynamic force on the 

structure due to precipitation or flooding. The lateral surcharge pressure on the structures due 

to the design PMP water level is calculated and does not govern the design of the below-grade 

walls. The load from water due to discharge of the FPS in the radiologically controlled area 

(RCA) is supported by slabs on grade. Drainage is provided for the mezzanine floor in the RCA 

to ensure that the mezzanine slab is not significantly loaded. The mezzanine floor slab is 

designed to a live load of 125 lb/ft2 (610 kilograms per square meter [kg/m2

]). Therefore, SHINE 

concludes that the mezzanine floor slab is capable of withstanding any temporary water 

collection that may occur while water is draining from the mezzanine floor.
Design of Structures, Systems, and Components

3-9

NUREG-1537, Part 1, Section 3.3, states, in part, that the applicant should specifically describe 

“... (2) the impact on systems resulting from instrumentation and control electrical or mechanical 

malfunction due to water, and (3) the impact on equipment, such as fans, motors, and valves, 

resulting from degradation of the electromechanical function due to water.” The staff noticed 

that PSAR Section 3.3, discusses water damage and PSAR Section 3.3.1.1.2, “Compartment 

Flooding from Fire Protection Discharge,” deals with flooding due to malfunction of the FPS, but 

Section 3.3 did not discuss the effects of discharge of the FPS on SSCs. Therefore, in 

RAI 3.3-1 (Reference 14), the staff asked that the applicant provide information on the effects of 

discharge from the FPS on SSCs. In response to RAI 3.3-1 (Reference 21), the applicant 

stated, in part, that “[t]he safety-related function(s) of SSCs that are subject to the effects of a 

discharge of the fire suppression system will be appropriately protected by redundancy, 

separation, and a fail-safe design of each SSC.” The applicant also stated, in part, that 

“electrical equipment may be protected from unacceptable damage, if wetted by fire sprinkler 

system discharge, by sprinkler water shields or hoods, consistent with National Fire Protection 

Association (NFPA) 13” (Reference 34). Additionally, the applicant indicated that fire 

suppression system discharge in one fire area will not impact safety-related SSCs in adjacent 

fire areas. 

The staff finds this response satisfies the acceptance criteria of NUREG-1537, Part 2, 

Section 3.3, and demonstrates adequate design criteria for a preliminary design. 

On the basis of its review, the staff has determined that the level of detail provided on 

hydrological damage is adequate and supports the preliminary design and satisfies applicable 

acceptance criteria of NUREG-1537, Part 2, Section 3.3. The staff concludes that the design 

criteria and designs would protect against potential hydrological (water) damage and would 

provide reasonable assurance that SSCs would continue to perform required safety functions, 

would not cause unsafe facility operation, would not prevent safe shutdown of the facility, and 

would not cause or allow uncontrolled release of radioactive material. 

Therefore, the staff finds that the facility design features to cope with hydrological damage is 

sufficient and meets the applicable regulatory requirements for issuance of a construction permit 

in accordance with 10 CFR 50.35. 

Seismic Damage

The staff evaluated the sufficiency of the facility design features in the case of a seismic event, 

as described in SHINE PSAR Section 3.4 using the guidance and acceptance criteria from 

Section 3.4, “Seismic Damage,” of NUREG-1537, Part 2.

Consistent with the review procedures of Section 3.4 of NUREG-1537, Part 2, the staff 

considered the site description and historical data to ensure that the appropriate seismic inputs 

have been considered. For any SSC damage, the staff considered the extent to which a 

seismic event would impair the safety function of the SSC.

SHINE PSAR Section 3.4.4 discusses that seismic instrumentation will be solid-state triaxial 

time-history accelerometers at essential locations that enable the prompt processing of the data. 

Additionally, the accelerometers will operate during all modes of facility operation. Maintenance 

and repair procedures will be developed to keep the maximum number of accelerometers in 

service during facility operation. In addition, the accelerometers will include provisions for 

in-service testing, the capability of periodic channel checks during normal facility operation, and 

the capability for in-place functional testing.
Design of Structures, Systems, and Components

3-10

SHINE PSAR Section 3.4.5.1, “Aircraft Impact Analysis,” provides an aircraft impact analysis 

since the SHINE facility is located near the SWRA.

SHINE PSAR Section 3.4.5.2, External Explosions,” provides an assessment of external 

explosions. Since SHINE is not a power reactor, the NRC Regulatory Guide 5.69, “Guidance 

for the Application of Radiological Sabotage Design-Basis Threat in the Design, Development 

and Implementation of a Physical Security Program that Meets 10 CFR 73.55 Requirements,” 

postulated explosions are not considered. Notwithstanding the above, SHINE was assessed for 

accidental explosions due to chemical reactions inside the facility, accidental explosions due to 

storage of hazardous materials outside the facility, and accidental explosions due to external 

transportation including aircraft impact.

SHINE PSAR Section 2.2.3.1.1, “Explosions,” provides the maximum overpressure at any 

safety-related area of the facility from any credible external source is less than 1 pounds per 

square inch (psi) (6.9 kilopascal [kPa]). This safety-related area is within the facility’s seismic 

boundary, and is thus protected by outer walls and roofs consisting of reinforced concrete that is 

strong enough to withstand the postulated external explosions defined in Regulatory 

Guide 1.91, Revision 1, “Evaluations of Explosions Postulated to Occur on Transportation 

Routes Near Nuclear Power Plants.”

NUREG-1537, Part 1, Section 3.4, “Seismic Damage,” states that the applicant should include 

information on the facility seismic design to provide reasonable assurance that the reactor could 

be shut down and maintained in a safe condition or that the consequences of accidents would 

be within the acceptable limits in the event of potential seismic events. To verify that seismic 

design functions are met, the applicant should give the bases for the technical specifications. 

NUREG-1537, Part 2, Section 3.4, states that the application should provide sufficient 

information to conclude that the design to protect against seismic damage provides reasonable 

assurance that the facility SSCs will perform the necessary safety functions described and 

analyzed. On the basis of its review, the staff has determined that the level of detail provided on 

seismic damage is adequate and satisfies the applicable acceptance criteria of NUREG-1537, 

Section 3.4, for a preliminary design.

SHINE PSAR, Section 3.4.2.2, “Soil-Structure Interaction Analysis,” reports that Soil-Structure 

interactions are performed separately for mean, upper bound, and lower bound soil properties to 

represent potential variations of the in situ and backfill soil conditions surrounding the building 

using the computer program Structural Analysis Software System Interface (SASSI). In 

RAI 3.4-1 (Reference 14), the staff asked that the applicant provide: (a) the reference manual 

and revision used for SASSI, (b) additional information explaining whether the geotechnical 

investigations requested above also determined the dynamic soil properties used for the 

soil-structure interaction analyses, and (c) the report with details and results for the 

soil-structure interaction analyses.

In response to RAI 3.4-1 (Reference 21), the applicant stated, in part, that “the soil-structure 

interaction analysis . . . was performed using the SASSI2010 software, Version 1.0. The 

SASSI2010, Version 1.0 User’s Manual contains proprietary information and, therefore, is 

available for NRC review at Sargent and Lundy’s offices.” The soil-structure interaction analysis 

used equivalent linear elastic material properties because the frequency domain analysis 
Design of Structures, Systems, and Components

3-11

method in SASSI requires the use of elastic material properties. The applicant used the 

following approach to determine the equivalent linear material properties for the dynamic 

analyses: 

(1) Shear wave and compression wave test results from Table A-1 of the Preliminary 

Geotechnical Engineering Report . . . were obtained and considered as the 

best-estimate (mean) soil properties (GBE). The soil test results provided mechanical 

properties at low shear strain level.

(2) Free field site response analyses were conducted for input seismic motions using the 

SHAKE2000 computer program to determine the shear strain compatible shear 

modulus and damping values for the design-basis seismic input motion. SHAKE2000 

uses an iterative nonlinear procedure to determine strain compatible soil properties 

from the geotechnical investigation results.

(3) The strain compatible soil properties obtained from the above procedure were input to 

SASSI and seismic analyses using the frequency domain method were conducted to 

determine seismic responses of the structure and to develop in-structure response 

spectra.

Additionally, the applicant stated, in part, that “[o]nly the best-estimate soil case is reported for 

the seismic analysis in [PSAR Section 3.4]. The variation of the soil properties will be 

considered in the final seismic analysis. Upper bound and lower bound soil properties (GUB and 

GLB) . . . and the coefficient of variation (COV) will be determined in accordance with 

[NUREG-0800, “Standard Review Plan for the Review of Safety Analysis Reports for Nuclear 

Power Plants: LWR Edition,” Section 3.7.2, “Seismic System Analysis”], and the results of the 

final seismic analysis will be provided in the FSAR.” The applicant also provided 

Calculation 2013-02413, “Soil-Structure Interaction Analysis of Shine Medical Isotope 

Production Facility for Design Seismic Event,” Revision 0 (Reference 22). Following the receipt 

of SHINE’s FSAR, the staff will confirm that the issue described above has been resolved in the 

final seismic analysis.

The staff finds this response satisfies the acceptance criteria of NUREG-1537, Part 2, 

Section 3.4 and demonstrates adequate design criteria for a preliminary design. 

NUREG-1537, Part 1, Section 3.4, states, in part, that “the applicant should specify and 

describe the SSCs that are required to maintain the necessary safety function if a seismic event 

should occur . . . facility seismic design should provide reasonable assurance that the reactor 

could be shut down and maintained in a safe condition or that the consequences of accidents 

would be within the acceptable limits.” In addition, NUREG-1537, Part 2, Section 3.4, states, in 

part, that the “review should include the designs and design bases of structures, systems, and 

components that are required to maintain function in case of a seismic event at the facility site.” 

The finding required is that the facility design should provide reasonable assurance that the 

reactor can be shut down and maintained in a safe condition. Therefore, in RAI 3.4-2 

(Reference 14), the staff asked that the applicant provide a comprehensive description of the 

SHINE facility structures required to maintain necessary safety functions should a seismic event 

occur.

In response to RAI 3.4-2 (Reference 21), the applicant described the SHINE IF and RPF 

structures necessary to provide safety functions. These structures included the supercells and 

tank farm, which make up the RCA. SASSI Thick concrete walls and roofs encase each 
Design of Structures, Systems, and Components

3-12

irradiation unit (IU) in a concrete vault, which is seismically designed. Additionally, IUs are 

housed within the IF and are separated from the RPF within the seismic boundary, as shown in 

SHINE PSAR Figure 1.3-2, “Production Building Floor Plans Preliminary Arrangement.” SHINE 

PSAR Figure 1.3-2 also shows the control room, battery rooms, uninterruptable power supply 

rooms, and other miscellaneous support rooms to the west. The RCA and these areas to the 

west of the RCA are part of the seismic boundary and are classified as Seismic Category I. 

These areas contain the safety-related SSCs. The applicant described the construction of these 

structures and stated that the concrete walls and slabs are designed for axial, flexural, and 

shear loads consistent with American Concrete Institute (ACI) 349-06, “Code Requirements for 

Nuclear Safety-Related Concrete Structures” (Reference 106). The applicant stated other areas 

of the facility contain non-safety-related equipment and, therefore, those areas are not Seismic 

Category I. 

Further, the applicant stated that during a seismic event, the forces will be transmitted through 

the structural reinforced concrete shear walls to the foundation mat and, ultimately, the soil. 

SHINE PSAR Section 3.4.2.6.4.7, “Soil Pressure,” describes how sub-grade walls of the facility 

are designed to resist the dynamic soil pressure loads that may occur during a seismic event. 

The staff finds this response satisfies the acceptance criteria of NUREG-1537, Part 1 and 2, 

Section 3.4 and demonstrates adequate design criteria for a preliminary design. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

NUREG-1537, Parts 1 and 2, Section 3.4, notes that acceptable seismic performance has been 

established in ANSI/ANS-15.7, “Research Reactor Site Evaluation.” With regard to seismic 

design, Section 3.2(2) of ANSI/ANS 15.7 states, “[r]eactor safety related structures and systems 

shall be seismically designed such that any seismic event cannot cause an accident which will 

lead to dose commitments in excess of those specified in 3.1.”

SHINE PSAR, Section 3.4.2.6.5, “Structural Analysis Model,” reports that a three-dimensional 

finite element structural analysis model of the SHINE facility structure was created using the 

SAP2000 computer program. Additionally, SHINE PSAR, Section 3.4.2.6.6, “Structural Analysis 

Results,” reports structural analysis results were obtained from the SAP2000 model. In 

RAI 3.4-3 (Reference 14), the staff asked that the applicant provide the reference manual and 

revision for the SAP2000 computer program that was used. In RAI 3.4-4 (Reference 14), the 

staff asked that the applicant provide the report with details and results for the SAP2000 finite 

element structural analyses.

In response to RAI 3.4-3 (Reference 21), the applicant stated that “Version 14.1 of the SAP2000 

computer program was used to develop the three-dimensional finite element model of the 

SHINE facility structure. The SAP2000 reference manual contains proprietary information and, 

therefore, is available for NRC review at Sargent and Lundy’s offices.” In response to RAI 3.4-4 

(Reference 21), the applicant provided Calculation 2013-01989, “Conceptual Design of 

Hardened SHINE Facility Structural Elements,” Revision 0, which contains the details and 

results of the SAP2000 finite element analysis.

The staff finds that these responses satisfy the acceptance criteria of NUREG-1537, Part 2, 

Section 3.4, and demonstrate adequate design criteria for a preliminary design. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.
Design of Structures, Systems, and Components

3-13

NUREG-1537, Part 1, Section 3.5, “Systems and Components,” states, in part, that the 

applicant should provide “the design bases for the systems and components required to function 

for safe reactor operation and shutdown.” This should include, at a minimum, the protective and 

safety systems; the electromechanical systems and components associated with emergency 

cooling systems, reactor room ventilation, confinement systems; and other systems that may be 

required to prevent uncontrolled release of radioactive material. The design criteria should 

include the conditions that are important for the reliable operation of the systems and 

components (e.g., dynamic and static loads, number of cyclic loads, vibration, wear, friction, and 

strength of materials).

NUREG-1537, Part 2, Section 3.5, “Systems and Components,” states, in part, that the reviewer 

should conclude there is sufficient information for the design bases of the electromechanical 

systems and components to give reasonable assurance that the facility systems and

components will function as designed to ensure safe operation and safe shutdown of the facility. 

SHINE PSAR, Section 3.4.3 states that seismic qualification of subsystems and equipment was

completed using five methods. In RAI 3.4-5, the staff asked that the applicant provide the 

details and results for seismically qualifying the SHINE facility subsystems and components. 

The staff also requested the applicant include an applicable explanation of whether and how the 

nodal accelerations (at the locations indicated in PSAR Figures 3.4-4 through 3.4-14 

(Reference 35) are used for the dynamic analyses of equipment.

In response to RAI 3.4-5 (Reference 21), the applicant stated that seismic qualification of piping 

systems classified as safety-related will be analyzed using the method identified in SHINE 

PSAR Section 3.4.3. The details of this analysis will be provided in the SHINE FSAR. 

Additionally, the applicant stated that seismic qualification of components was achieved with 

one of the following methods: (1) qualification by analytical methods (including static analysis, 

simplified dynamic analysis, or detailed dynamic analysis); (2) qualification by testing (e.g., pull 

testing); or (3) a combination of the analytical and testing methods. 

The staff finds these responses satisfy the acceptance criteria of NUREG-1537, Part 2, 

Section 3.4 and demonstrate adequate design criteria for a preliminary design. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

NUREG-1537, Part 2, Section 3.4, states that the applicant should demonstrate that all potential 

consequences from a seismic event are within the acceptable limits considered or bounded in 

the accident analyses of Chapter 13 to ensure that conditions due to a seismic event will not 

pose significant risk to the health and safety of the public. In addition, NUREG-1537, Part 1, 

Section 3.4, states that in order to verify that seismic design functions are met, the applicant 

should give the technical specifications necessary to ensure operability, testing, and inspection 

of associated systems, including instrumentation and controls. SHINE PSAR, Section 3.4.4 

states that the seismic instrumentation operates during SHINE facility operation. The 

maintenance and repair procedures will keep the maximum number of instruments in service. 

The inservice testing provisions include periodic channel checks and the capability for in-place 

functional testing. In RAI 3.4-6 (Reference 14), the staff asked that the applicant: (a) provide a 

summary description of the data these instruments record in the event of felt earthquake 

motions (i.e., acceleration time histories); and, (b) provide an explanation of the data retrieval 

and processing procedure(s). Additionally, the staff asked that the applicant clarify whether a 

separate computer is required to view the digitized acceleration time histories and generate 

response spectra.
Design of Structures, Systems, and Components

3-14

In response to RAI 3.4-6 (Reference 20), the applicant stated, in part, that:

. . .neither NUREG-1537 nor the ISG augmenting NUREG-1537 require seismic 

instrumentation for research reactors or isotope production facilities. Seismic 

instrumentation is not required as referenced under 10 CFR Part 50, “Domestic 

Licensing of Production and Utilization Facilities,” Appendix S, “Earthquake 

Engineering Criteria for Nuclear Power Plants,” Section IV(a)(4) to or 

10 CFR Part 100, “Reactor Site Criteria,” Appendix A, “Seismic and Geologic 

Siting Criteria for Nuclear Power Plants,” Section VI(a)(3), since the SHINE 

facility is not a nuclear power plant. Therefore, SHINE has decided not to install 

seismic instrumentation. The applicant stated that an Issues Management 

Report (IMR) has been initiated to remove the reference to installed seismic 

instrumentation from PSAR Section 3.4.4. Should a seismic event be felt at the 

SHINE facility . . . as stated in the SHINE Preliminary Emergency Plan 

[Reference 3]. The operators will place the plant in a safe condition until the 

event can be evaluated and the determination is made that safe operations can 

be commenced. Facility procedures will be used to systematically assess the 

operability and functionality of the plant SSCs. The magnitude of the event will 

be determined using information available from USGS or other authoritative 

source.

In Chapter 13, Section 13a.4.6, “External Events,” of this SER, the staff determined that for 

events that cause facility damage, the damage is within the bounds discussed for other 

accidents and does not result in dose consequences and the consequences of all design-basis 

accident (DBA) external events have been analyzed and shown to be bounded by the maximum 

hypothetical accident (MHA). Therefore, SHINE response to this RAI is acceptable. 

NUREG-1537, Part 2, Section 3.4, states that “[t]he applicant should demonstrate that all 

potential consequences from a seismic event are within the acceptable limits considered or 

bounded in the accident analyses of Chapter 13 to ensure that conditions due to a seismic 

event will not pose a significant risk to the health and safety of the public.” The SHINE site 

location is near the SWRA. SHINE PSAR Section 3.4.5.1 outlines the methodology for 

conducting and evaluating small aircraft impact analyses for the seismic envelope design for 

external hazards. The potential locations for 25 aircraft impact analyses of the SHINE facility 

are listed.

SHINE PSAR Table 3.4-4, “Aircraft Impact Analysis Results,” shows that the performance of all 

barriers is acceptable to prevent transport of radioactive materials to unrestricted areas. 

However, the staff noticed that the engineering report that describes the analyses’ details states 

that all of the results are not referenced. In RAI 3.4-7 (Reference 14), the staff asked that the 

applicant provide the engineering report that describes the aircraft impact analyses’ details that 

reports the results and also asked that the applicant to provide a summary of the results.

In its response to RAI 3.4-7 (Reference 21), the applicant provided Calculation 2013-01911, 

“Evaluation for Aircraft Impact,” Revision 0, which contains the details and results of the aircraft 

impact analyses. The applicant stated that:

Calculation 2013-01911 evaluates the initial design of the SHINE Medical Isotope 

Production Facility at Janesville, Wisconsin for effects of an accidental aircraft 

crash by aircrafts operating through the SWRA. As described in Calculation 

2013-01911, Section 4.1, the Challenger 605 is selected as the design-basis 
Design of Structures, Systems, and Components

3-15

aircraft for performing the evaluations. Calculation 2013-01911, Figures 4.4.1-1 

(A) and 4.4.1-1 (B), show the walls and roof slabs evaluated for the facility. Roof 

panels and walls are two-foot thick reinforced concrete with a design strength of 

5000 psi. Roof slabs are supported on trusses spanning in the east-west 

direction. These trusses are supported on external walls and either on an 

internal wall running in the north-south direction or on a plate girder spanning in 

the north-south direction. 

Evaluations are made for local damage and overall damage in Calculation 

2013-01911, Sections 5.2 and 5.3, respectively. Local damage evaluation 

results show that the two-foot thick reinforced concrete panels do not scab under 

the impact from the engine of the impacting aircraft. Calculation results for 

perforation margin show that the condition of ACI 349-06, Paragraph F.7.2.3, is 

satisfied. Therefore, a punching shear evaluation in the overall response 

assessment is not necessary. 

The overall damage evaluation is performed in Section 5.3 of the calculation, 

considering 25 cases of impact. Calculation 2013-01911, Section 4.4.4, 

describes the impact cases. Calculation 2013-01911, Table 6-1, and SHINE 

PSAR Table 3.4-4 summarize the acceptability of the 25 impact cases, provided 

stated conditions for reinforcement size and spacing, including shear ties, and 

provisions for truss members, including a non-linear analysis in the future to 

show that the acceptability of inelastic deformation, are met.

The staff finds that this response satisfies the acceptance criteria of NUREG-1537, Part 2, 

Section 3.4, and demonstrates adequate design criteria for a preliminary design. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

NUREG-1537, Part 1, Section 3.4 states that the applicant should include information on the 

facility seismic design to provide reasonable assurance that the reactor could be shut down and 

maintained in a safe condition or that the consequences of accidents would be within the 

acceptable limits in the event of potential seismic events. NUREG-1537, Part 2, Section 3.4, 

states that the staff should find sufficient information to conclude that the design to protect 

against seismic damage provides reasonable assurance that the facility SSCs will perform the 

necessary safety functions described and analyzed.

While SHINE’s response to RAI 3.4-1(b) (Reference 21) provided additional information on free 

field site response analyses using the SHAKE2000 computer program, the response did not 

include a reference for the version of the SHAKE2000 computer program used in SHINE’s 

seismic analysis. In RAI 3.4-8 (Reference 16), the staff asked that the applicant provide the 

reference for the version of the SHAKE2000 computer program used in SHINE’s seismic 

analysis. In its response to RAI 3.4-8 (Reference 24), the applicant provided that Version 3.5 of 

the SHAKE2000 computer program was used in the SHINE seismic analysis.

The staff finds this response satisfies the acceptance criteria of NUREG-1537, Part 2, 

Section 3.4 and demonstrates adequate design criteria for a preliminary design. 

NUREG-1537, Part 1, Section 3.4, states, in part, that in order to verify that seismic design 

functions are met, “the applicant should give the bases for technical specifications necessary to 

ensure operability, testing, and inspection of associated systems, including instrumentation and 
Design of Structures, Systems, and Components

3-16

controls, if applicable.” NUREG-1537, Part 2, Section 3.4, states, in part, that, “the applicant 

should demonstrate that the surveillance activities proposed provide reasonable assurance that 

the safety-related functions of the SSCs that are required to respond to, or mitigate the 

consequences of, seismic damage to the facility will be maintained.”

SHINE PSAR Section 3.4.4, states that the seismic instrumentation operates during SHINE 

facility operation. The maintenance and repair procedures will keep the maximum number of 

instruments in service. The in-service testing provisions include periodic channel checks and 

the capability for in-place functional testing.

However, in its response to RAI 3.4-6 (Reference 20), SHINE stated that seismic 

instrumentation will not be installed at the SHINE facility, because it is not required to install 

such instrumentation under 10 CFR Part 50 or 10 CFR Part 100. SHINE instead stated, in part, 

that “procedures will be used to systematically assess the operability and functionality of the 

plant SSCs. The magnitude of the event will be determined using information available from the 

U.S. Geological Survey (USGS) or other authoritative source.”

While the USGS and other authoritative sources could provide information such as the epicenter 

location or focal mechanism for a felt earthquake at the SHINE facility, the staff notes those 

sources cannot provide the acceleration time histories or response spectra experienced at the 

facility needed to conduct post-earthquake quantified evaluations and re-qualifications of the 

facility Seismic Category I and Seismic Category II SSCs. The staff needed additional 

information to determine that the safety-related functions of the SSCs that are required to 

respond to, or mitigate the consequences of, seismic damage to the facility will be maintained. 

Therefore, in RAI 3.4-9 (Reference 16), the staff asked that the applicant provide a discussion of 

the methodology that will be used to develop procedures for post-earthquake evaluations and 

re-qualifications of Seismic Category I and Seismic Category II SSCs without onsite seismic 

instrumentation recording information such as acceleration time histories and response spectra.

In response to RAI 3.4-9 (Reference 24), the applicant stated that seismic instrumentation is not 

required by Section IV(a)(4) of Appendix S to 10 CFR 50 or Section VI(a)(3) of Appendix A to 

10 CFR Part 100, since the SHINE facility is not a nuclear power plant. However, SHINE has 

decided that for asset protection and business operations purposes, non-safety-related seismic 

instrumentation could assist with the timely determination of the accelerations experienced at 

the plant following a seismic event. Therefore, SHINE will acquire and install a 

non-safety-related seismic monitoring system to help establish the acceptability of continued 

operation of the plant following a seismic event. This system will provide acceleration time 

histories or response spectra experienced at the facility to assist in verifying that SSCs 

important to safety at the SHINE facility can continue to perform their safety functions. SHINE 

will provide an explanation of the data retrieval and processing procedure(s) and state whether 

or not a separate computer is required to view the digitized acceleration time histories and 

generate response spectra in the FSAR. Following the receipt of SHINE’s FSAR, the staff will 

confirm that this issue has been resolved.

The staff finds this response satisfies the acceptance criteria of NUREG-1537, Part 2, 

Section 3.4, and demonstrate adequate design criteria for a preliminary design. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

On the basis of its review, the staff has determined that the level of detail provided on seismic 

damage is adequate and supports the preliminary design and satisfies the applicable 
Design of Structures, Systems, and Components

3-17

acceptance criteria of NUREG-1537, Part 2, Section 3.4. The staff concludes that: (1) the 

design criteria and designs should provide reasonable assurance that SSCs would continue to 

perform required safety functions following a seismic event; and (2) the design to protect against 

seismic damage provides reasonable assurance that the consequences of credible seismic 

events will be considered and adequately protect public health and safety.

Therefore, the staff finds that the facility design features to cope with seismic damage is 

sufficient and meets the applicable regulatory requirements and guidance for issuance of a 

construction permit in accordance with 10 CFR 50.35. Further technical or design information 

required to complete the safety analysis may reasonably be left for later consideration. The 

staff will confirm that the final design conforms to this design basis during the evaluation of 

SHINE’s FSAR.

Systems and Components

The staff evaluated the sufficiency of the facility design features for systems and components, 

as described in SHINE PSAR Section 3.5 using the guidance and acceptance criteria from 

Section 3.5 of NUREG-1537, Part 2 and the ISG Augmenting NUREG-1537, Part 2. 

Consistent with the review criteria of NUREG-1537, Part 2, Section 3.5, the staff verified that the 

design bases for the SSCs that are required to ensure safe operation of the facility are 

described in detail in Section 3.5 or other PSAR sections in sufficient detail.

Additionally, SHINE PSAR Section 3.5 states the following:

Sections 3.5a and 3.5b discuss the conditional application of Appendix A to 

10 CFR 50, “General Design Criteria for Nuclear Power Plants,” and 10 CFR 

70.64, “Requirements for New Facilities or New Processes at Existing Facilities,” 

as good design practice. Although not mandatory, these design criteria provide a 

rational basis from which to proceed.

Based on this statement, the staff review also included PSAR Table 3.5a-1, “Appendix A to 

10 CFR 50 General Design Criteria Which Have Been Interpreted as They Apply to the SHINE 

Irradiation Facility,” and PSAR Table 3.5b-1, “Baseline and General Design Criteria for 

Radioisotope Production Facility.”

Further, consistent with the guidance in the ISG augmenting NUREG-1537, Part 2, Section 3.5, 

while compliance with 10 CFR 70.64 is not required for this type of facility, if the applicant can 

adequately address the baseline design criteria in 10 CFR 70.64, it would be found acceptable 

by the staff. Therefore, since the SHINE PSAR compares the facility against the baseline 

design criteria of 10 CFR 70.64, the additional basis of NUREG-1520, “Standard Review Plan 

for the Review of a License Application for a Fuel Cycle Facility,” Section 3.4.3.2, was included 

in the review which encompassed how the design of the facility addresses each baseline design 

criterion.

In 10 CFR 50.2, “Definitions,” safety-related SSCs are defined as follows:

Safety-related structures, systems and components means those structures, 

systems and components that are relied upon to remain functional during and 

following design-basis events to assure:
Design of Structures, Systems, and Components

3-18

(1) The integrity of the reactor coolant pressure boundary; 

(2) The capability to shut down the reactor and maintain it in a safe shutdown 

condition; or, 

(3) The capability to prevent or mitigate the consequences of accidents which 

could result in potential offsite exposures comparable to the applicable 

guideline exposures set forth in § 50.34(a)(1) or § 100.11 of this chapter, as 

applicable.

In 10 CFR 70.4, “Definitions,” items relied on for safety (IROFS) are defined as follows:

Items relied on for safety mean structures, systems, equipment, components, 

and activities of personnel that are relied on to prevent potential accidents at a 

facility that could exceed the performance requirements in § 70.61 or to mitigate 

their potential consequences. This does not limit the licensee from identifying 

additional structures, systems, equipment, components, or activities of personnel 

(i.e., beyond those in the minimum set necessary for compliance with the 

performance requirements) as items relied on for safety.

SHINE PSAR, Section 3.5.1, “Classification of Systems and Components Important to Safety,”

discusses the classification of SSCs. SHINE PSAR, Section 3.5.1.1, “Nuclear Safety 

Classifications for SSCs,” states that SHINE uses a modified definition from 10 CFR 50.2 to 

develop the definition of safety-related SSCs, where appropriate, utilizing a portion of 

10 CFR 70.4. SHINE PSAR, Section 3.5.1.2, “Quality Assurance (Quality Group Classifications 

for SSCs),” discusses how safety-related SSCs and safety-related activities will be classified as 

QL-1. Selected SSCs and activities supporting or protecting the safety function of safety-related 

equipment will be classified as QL-2. The section goes on to state that safety-related SSCs 

shall have “the full requirements of the Quality Assurance Program Description (QAPD) in 

accordance with an approved Quality Assurance Plan (QAP).” In addition, SHINE PSAR 

Section 3.5.2, “Seismic Classification,” states, in part, that safety-related SSCs are Seismic 

Category I. 

Therefore, in RAI 3.5-1 (Reference 14), the staff asked that the applicant: (1) provide the basis 

referencing the definition of safety-related SSCs in 10 CFR 50.2, the basis for using a modified 

definition of safety-related SSCs, the basis for utilizing only a portion of the requirements of 

10 CFR 70.61, “Performance requirements,” and the basis for why the 10 CFR 70.61 

requirements do not encompass SHINE’s modified definition of safety-related SSCs; (2) define 

and provide the basis for the difference between QL-1 and QL-2; and (3) if there are two SSCs 

(i.e., pipe, valve, tank, heat exchanger, etc.) that must meet the same performance 

characteristics but one SSC is governed by QL-1 and the other by QL-2, the staff asked that the 

applicant describe how they will be physically different. Finally, with respect to Seismic 

Category I, the staff asked that the applicant clarify the differences in Seismic Category I 

acceptance criteria under QL-1 and QL-2.

In response to RAI 3.5-1 (Reference 20), the applicant stated that it referenced 10 CFR 50.2 

definition of safety-related because it incorporates specific, measurable attributes that are at 

least equivalent to the definition of safety-related items contained in ANSI/ANS-15.8-1995 

(R2013), “Quality Assurance Program Requirements for Research Reactors.” Section 1.3 of 

ANSI/ANS-15.8-1995 (R2013) states the following:
Design of Structures, Systems, and Components

3-19

Safety-related items. Those physical structures, systems, and components 

whose intended functions are to prevent accidents that could cause undue risk to 

the health and safety of workers and the public, or to the research reactor’s 

programs; and to control or mitigate the consequences of such accidents.

The applicant stated that the reference of the 10 CFR 50.2 definition of safety-related SSCs for 

the IF results in a clear demarcation of safety-related equipment, principally the boundary 

necessary to contain fissile material, the ability to terminate the fission process and ensure its 

safe condition after shutdown, and ensure that releases of materials in accidents are limited to 

ensure 10 CFR Part 20, “Standards for Protection Against Radiation,” regulations are met. 

Further, the applicant asserted when considering the 10 CFR 50.2 definition as written, 

Items (1) and (2) of the definition do not apply to any SSCs in the facility, as SHINE does not 

have a reactor. Components would be classified according to Item (3) alone. Therefore, by 

modifying Items (1) and (2) of the definition, the applicant has incorporated additional SSCs into 

the safety-related classification. The applicant stated that this modified definition and the 

accident analysis process detailed in PSAR Chapter 13 ensures that the health and safety of 

the worker and the public off-site are adequately protected through proper selection of 

safety-related SSCs to prevent accidents and control and mitigate their consequences and by 

ensuring that worker and public doses are less than the limits of 10 CFR Part 20 during potential 

accidents. Finally, the applicant determined that a modification of the definition of safety-related 

will ensure that SSCs important to safety in the RPF are completely encompassed by the 

safety-related definition. SHINE has incorporated chemical and criticality-safety aspects into the 

classification of safety-related SSCs. SHINE is proposing this alternate methodology for 

designating SSCs important to safety for both the IF and RPF based on the SHINE definition of 

safety-related. 

The applicant identified a complete set of initiating events and accidents for the entire facility in 

the Integrated Safety Analysis (ISA) performed for the preliminary design. The ISA will be 

updated as part of the detailed design with any necessary changes and will be renamed the 

“SHINE Accident Analysis,” following issuance of the operating license. The applicant states 

the ISA and the SHINE facility design achieve the following objectives: (1) ensures that the 

complete set of initiating events has been considered; (2) categorizes the initiating events and 

accidents by type, and determines the limiting cases in each group to be quantitatively 

analyzed; (3) meets 10 CFR Part 20 acceptance criteria (i.e., 5 roentgen equivalent man [rem] 

total effective dose equivalent [TEDE] to the worker and 100 millirem [mrem] TEDE to a 

member of the public off-site) for the consequences of each postulated event; (4) ensures the 

necessary SSCs are included in the design to prevent criticality; and, (5) ensures the necessary 

SSCs are included in the design to prevent undue risk to the health and safety of workers and 

the public from accidents involving chemicals produced from licensed material. 

The applicant stated analyses will be performed to identify the SSCs in the facility that are 

necessary to prevent or mitigate accidents, consistent with applicable acceptance criteria. 

Those SSCs will be designated safety-related. The results of the analyses and the designations 

of safety-related SSCs will be included in the PSAR and FSAR. The SSCs meeting the 

provisions of 10 CFR 50.36, “Technical specifications,” will be included in the facility’s technical 

specifications and will be subject to the provisions of 10 CFR 50.90, “Application for amendment 

of license, construction permit, or early site permit.” 

The applicant also provided that a configuration management program will be established to 

evaluate, implement, and track each change to the site, structures, processes, systems, 

equipment, components, computer programs, and activities of personnel that affect the safety 
Design of Structures, Systems, and Components

3-20

analysis or licensing basis. The applicant also stated that following issuance of the operating 

license, changes to the SHINE facility that affect the accident analysis will be resolved using the 

failure modes and effects analysis (FMEA) or another suitable accident analysis technique to 

assure that the SHINE facility configuration is maintained consistent with the licensing basis. 

Changes to the accident analysis will be evaluated under 10 CFR 50.59, “Changes, tests and 

experiments,” to determine if NRC approval is required. If so, 10 CFR 50.90 will be used.

The applicant also provided the following updated definition of safety-related: 

Safety-Related SSCs: Those SSCs that are relied upon to remain functional 

during normal conditions and during and following design basis events to assure:

1. The integrity of the primary system boundary (PSB);

2. The capability to shut down the TSV [target solution vessel] and maintain 

the target solution in a safe shutdown condition;

3. The capability to prevent or mitigate the consequences of accidents which 

could result in potential exposures comparable to the applicable guideline 

exposures set forth in 10 CFR Part 20;

4. That the potential for an inadvertent criticality accident is not credible;**

5. That acute chemical exposures to an individual from licensed material or 

hazardous chemicals produced from licensed material could not lead to 

irreversible or other serious, long-lasting health effects to a worker or 

cause mild transient health effects to any individual located outside the 

owner controlled area; or,

6. That an intake of 30 mg [milligrams] or greater of uranium in soluble form 

by any individual located outside the owner controlled area does not 

occur.

** The applicant later revised this part of the definition in a response to 

RAI 3.5-6, which is discussed below.

Related to quality levels, the applicant provided a revised QAPD, which included an updated 

discussion on the graded approach to quality. The QAPD realigns and redefines the quality 

levels as follows:

• QL-1 shall implement the full measure of the QAPD and shall be applied to 

safety-related SSCs.

• QL-2 will include the non-safety-related quality activities performed by the licensee that 

are deemed necessary by SHINE to ensure the manufacture and delivery of highly 

reliable products and services to meet or exceed customer expectations and 

requirements.

The applicant stated that as a result of further design work and this response, the ISA and ISA 

Summary will be reviewed and updated. Further, the applicant will incorporate additional 

changes into to the SHINE FSAR, as a result of updates to the ISA and ISA Summary. 
Design of Structures, Systems, and Components

3-21

As discussed above, the applicant modified the definition of safety-related in the SHINE PSAR 

to encompass those SSCs that are required for safety in both the IF and the RPF. The 

components meeting the revised safety-related definition are classified as QL-1, and therefore, 

there will be no difference in regards to the quality classification or Seismic Category I 

acceptance criteria for two SSCs that must meet the same performance characteristics.

The staff finds the applicant’s response to RAI 3.5-1, as revised by the response to RAI 3.5-6 

(discussed below) is consistent with: (1) the guidance provided in the ISG augmenting 

NUREG-1537, Part 1, (2) ISA methodologies as described in 10 CFR Part 70, “Domestic 

Licensing of Special Nuclear Material,” and NUREG-1520, and (3) application of the radiological 

and chemical consequence and likelihood criteria contained in the performance requirements of 

10 CFR 70.61. Additionally, the staff finds this response consistent with the ISG augmenting 

NUREG-1537, Part 1, which states, in part, that “[a]pplicants may propose alternate accident 

analysis methodologies, alternate radiological and chemical consequence and likelihood criteria, 

alternate safety features, and alternate methods of assuring the availability and reliability of the 

safety features.” 

NUREG-1537, Part 2, Section 3.5 “Acceptance Criteria,” states, in part, that the design criteria 

should include the “response to transient and potential accident conditions analyzed in the 

safety analysis report (SAR).” 

SHINE PSAR, Section 3.5.2 states, in part, that SSCs that have “[t]he capability to prevent or 

mitigate potential accidents at the facility that could exceed the performance requirements in 

10 CFR 70.61,” are designated Seismic Category I. The performance requirements include 

mitigating the effects of an “acute chemical exposure to an individual from licensed material or 

hazardous chemicals produced from licensed material....” SHINE PSAR Figure 1.3-2 has the 

following notation: “Heavy Outline Denotes Seismic Boundary.” In addition, SHINE PSAR 

Table 3.5-1, “System and Classifications,” (pages 3-52 – 3-55), states that the facility structure 

is safety-related, Seismic Category I, and QL-1. There is no mention of the seismic 

classification of the north and south portions of the building outside the seismic boundary, which 

include chemical storage facilities. The staff noted that this statement appeared to infer that 

these portions of the building are non-seismic and in a postulated design-basis earthquake, they 

could collapse. If all of the access points into the “seismic boundary” are located on the north 

and south sides of the building, it is possible that personnel would not be able get in or out of 

the building after a design-basis earthquake and individuals could be exposed to licensed 

material and/or hazardous chemicals. Therefore, in RAI 3.5-2 (Reference14), the staff asked 

that the applicant provide clarification on the seismic design of the north and south portions of 

the building and address how the 10 CFR 70.61 performance requirements are met.

In response to RAI 3.5-2 (Reference 20), the applicant stated that the RPF building seismic 

portion will be provided with at least two safety-related seismic access points in the final design, 

enabling personnel to exit the building following a seismic event. These exits will ensure that 

personnel will be able to exit the building and, therefore, will not be exposed to licensed 

material, a chemical exposure from licensed material, or hazardous chemicals produced from 

licensed material in excess of the guidelines described in the PSAR. Following the receipt of 

SHINE’s FSAR, the staff will confirm that this issue has been resolved.

The staff finds this response satisfies the acceptance criteria of NUREG-1537, Part 2, 

Section 3.5, and demonstrates adequate design criteria for a preliminary design. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.
Design of Structures, Systems, and Components

3-22

NUREG-1537, Part 2, Section 3.5, “Acceptance Criteria,” states, in part, that the design criteria 

should include “response to transient and potential accident conditions analyzed in the safety 

analysis report (SAR).” 

SHINE PSAR Table 3.5-1 states the following:

Radiologically Controlled Area Ventilation Zone 1 (RVZ1) is safety-related, QL-1, 

and Seismic Category I; 

Radiologically Controlled Area Ventilation Zone 2 (RVZ2) is safety-related, QL-1, 

and Seismic Category I; and 

Radiologically Controlled Area Ventilation Zone 3 (RVZ3) is non-safety-related, 

QL-3, and Seismic Category III. 

SHINE PSAR Section 9a.2.1.1, “Radiologically Controlled Area Ventilation System,” does not 

state that one normally goes through RVZ3 to get to RVZ1 or RVZ2, but such a pathway can be 

inferred from PSAR Figure 1.3-2. Thus, RVZ3 would be used for access and egress after a 

postulated event with a loss of off-site power (LOOP) or a design-basis earthquake with a power 

LOOP.

Therefore, in RAI 3.5-3 (Reference 14), the staff asked that the applicant provide the basis for 

designating the RVZ3 as non-safety-related, QL-3, and Seismic Category III, or provide a 

discussion of the alternate method of access/egress of the RVZ1 and RVZ2.

In response to RAI 3.5-3 (Reference 21), the applicant stated that RVZ3 is designated as 

non-safety-related and QL-2 because it does not meet the SHINE definition of a safety-related 

SSC (See also RAI 3.5-1 response), in that:

1. RVZ3 is not relied upon to maintain the integrity of the primary system 

boundary (PSB).

2. RVZ3 is not relied upon to shut down the target solution vessel (TSV) or 

maintain the target solution in a safe shutdown condition.

3. RVZ3 is not relied upon to prevent or mitigate the consequences of accidents 

which could result in potential exposures comparable to the applicable 

guideline exposures set forth in 10 CFR 20. This function, as it relates to 

ventilation, is accomplished by RCA Ventilation Zone 1 (RVZ1) and RCA 

Ventilation Zone 2 (RVZ2), the ventilation systems used in areas containing 

radiological material.

4. RVZ3 is not relied upon to assure that an inadvertent criticality accident is not 

credible.

5. RVZ3 is not relied upon to assure that acute chemical exposures to an 

individual from licensed material or hazardous chemicals produced from 

licensed material could not lead to irreversible or other serious, long-lasting 

health effects to a worker or cause mild transient health effects to any 

individual located outside the owner controlled area. This function, as it 
Design of Structures, Systems, and Components

3-23

relates to ventilation, is accomplished by RVZ1 and RVZ2, the ventilation 

systems used in areas containing licensed material.

6. RVZ3 is not relied upon to ensure that an intake of 30 mg or greater of 

uranium in soluble form by any individual located outside the owner controlled 

area does not occur. This function, as it relates to ventilation, is 

accomplished by RVZ1 and RVZ2, the ventilation systems used in areas 

containing uranium in soluble form. 

RVZ3 is classified as Seismic Category III because it is a non-safety-related 

system, and does not adversely impact SSCs important to safety that are 

designed to withstand the effects of a design basis earthquake and remain 

functional.

The applicant further stated that contamination would not be expected with a loss-of-offsite 

power because there are no external events that result in both a loss-of-offsite power and a 

radiological release. However, if the RVZ3 fans are not operating during a radiological event, 

then emergency response consistent with the SHINE Preliminary Emergency Plan will evaluate 

and control contamination.

The staff finds that SHINE provided an adequate justification for the classification of the RVZ3 

for preliminary design based on: (1)the response to RAI 3.5-3; (2) the information provided in 

response to RAI 9a2.1-3; (3) the fact that RVZ3 consists only of the airlocks that provide access 

to the RCA; (4) the airlocks are within the RCA boundary and thus within the Seismic Category I 

structure; (5) forced air is supplied to the airlocks via flow control valves (i.e., there are no 

powered fan systems associated with the airlocks, their air supply comes from safety-related 

RCA heating, ventilation, and air conditioning [HVAC] systems); and (6) forced air supplied to 

RVZ3 is then transferred to RVZ2 spaces through engineered airlock door leakage pathways. 

The staff will further evaluate SHINE’s classification of RVZ3 during its evaluation of SHINE’s 

FSAR.

In SHINE PSAR Table 3.5-1, the facility instrument air system, the facility control room, the 

stack release monitoring system, the health physics monitors, the facility breathing air Stack 

Release Monitoring System, the Health Physics Monitors, the Facility Breathing Air system, the 

facility data and communications system, the emergency lighting system, the facility ventilation 

zone 4 system, and the Lighting System are all non-safety-related, QL-3, Seismic Category III 

and the standby diesel generator system is non-safety-related, QL-3, Seismic Category II. In 

addition, the PSAR states that RCA ventilation systems require power to operate.

Therefore, in RAI 3.5-4 (Reference 14), the staff asked that the applicant provide a discussion 

that addresses how facility personnel will be able to determine that the facility is in a safe 

condition (or put the facility in a safe condition) and how the facility will be maintained in a safe 

condition, in the event of a postulated design-basis earthquake with a LOOP and unavailability 

of the systems above.

In response to RAI 3.5-4 (Reference 20), the applicant stated that in the event of a postulated 

design-basis earthquake with a loss-of-offsite power, facility personnel will be able to determine 

if the facility is in a safe condition and maintain it in such a state as necessary using 

safety-related equipment. The SHINE facility control room is part of a safety-related, Seismic 

Category I structure. The applicant also stated that PSAR Table 3.5-1 incorrectly stated that the 

facility control room is a non-safety-related (NSR), Seismic Category III structure and that 
Design of Structures, Systems, and Components

3-24

designation of the facility control room will be corrected in the FSAR. The control room contains 

the necessary safety-related controls and indicators to maintain the facility in a safe condition. 

In the event of a loss-of-offsite power, safety-related equipment either fails to its safe condition 

or is powered by the uninterruptible electrical power supply system (UPSS). The automatic 

safety systems designed to protect the public and maintain the facility in a safe shutdown 

condition operate without operator intervention. The safety-related RCA ventilation isolates, as 

necessary, to contain radioactive releases. The isolation components are fail-safe and move to 

their safe position upon a loss of power. The applicant’s response to RAI 3.5-1 provided the 

SHINE definition of safety-related SSCs. The following systems are not necessary for 

personnel to determine that the facility is in a safe condition or to place the facility in a safe 

condition, and are not defined as safety-related using the SHINE definition of safety-related 

SSCs: facility instrument air system, stack release monitoring system, health physics monitors,

facility breathing air system, facility data and communication system, lighting system, 

emergency lighting system, and FVZ4 standby diesel generator system. The applicant noted 

that none of these systems are used to prevent or mitigate the consequences of accidents, as 

presented in PSAR Chapter 13.

The staff finds the applicant’s response addresses how it will meet the requirements of

10 CFR 50.34(a)(4) and demonstrates adequate design criteria for a preliminary design. The 

staff will confirm that the final design conforms to this design basis during the evaluation of 

SHINE’s FSAR.

SHINE PSAR Section 3.5.2 discusses the use of Seismic Category II SSCs over Seismic 

Category I SSCs (Seismic II/I). SHINE PSAR, Table 3.5a-1 as (pages 3-88 – 3-93) discusses 

how the facility complies with 10 CFR Part 50, Appendix A, “General Design Criteria.” Based on 

SHINE’s proposed implementation of the general design criteria, the NRC staff needs 

clarification on the following considerations with respect to Seismic Categories II/I:

General Design Criterion 1 provides that structures, systems, and components 

important to safety are to be designed, fabricated, erected, and tested to quality 

standards. Thus, General Design Criterion 1 applies to Seismic II/I since the 

Seismic II structures, systems, and components should be properly designed, 

fabricated, and installed to reduce the likelihood of a Seismic Category II 

structure, system, or component coming loose and falling on and damaging a 

Seismic Category I structure, system, or component.

General Design Criterion 2 provides that structures, systems, and components 

important to safety are to be designed to resist the effects of natural phenomena 

like earthquakes. General Design Criterion 2 applies to Seismic II/I because it 

specifies the natural phenomenon (i.e., earthquake) that must be considered in 

the design of these structures, systems, and components. If not considered, an 

earthquake could loosen a Seismic Category II structure, system, or component 

to the extent that it could cause an unsafe condition (i.e., fall on and damage a 

Seismic Category I structure, system, or component).

General Design Criterion 4 provides that structures, systems, and components 

important to safety are to be protected against the effects of internally-generated 

missiles. General Design Criterion 4 applies to Seismic Category II structures, 

systems, and components because it specifies protection against the effects of 

internally-generated missiles (i.e., fall on and damage of a Seismic Category I 

structure, system, or component).
Design of Structures, Systems, and Components

3-25

The staff notes that, based on the considerations above, dropped loads could cause the 

potential release of radioactive materials, a criticality accident, or damage to essential safety 

equipment, which could cause unacceptable radiation exposures.

Therefore, in RAI 3.5-5 (Reference 14), the staff asked that the applicant provide details of the 

SHINE Seismic II/I program that will be put into place, including the Seismic Category II 

structural integrity criteria and the Seismic Category II support criteria.

In response to RAI 3.5-5 (Reference 21), the applicant referred to PSAR Section 3.5.2, which 

states that structures, components, equipment, and systems designated as safety-related are 

classified as Seismic Category I. The applicant put criteria in place for Seismic Category II 

SSCs to ensure that they do not interfere with Seismic Category I SSCs as described below:

Criteria for Seismic Category II Structures

Nonsafety-related structures are designed with the following two general criteria:

1. SSCs in nonsafety-related structures attached to a safety-related 

structure or separated from a safety-related structure by a distance less 

than or equal to the height of the nonsafety-related structure are designed 

for abnormal and extreme environmental loads if the failure of the 

nonsafety-related SSC could result in damage to safety-related SSCs. 

However, if the failure of the nonsafety-related SSC will not result in 

damage to safety-related SSCs, the nonsafety-related SSC need not be 

designed for abnormal and extreme environmental load combinations.

2. Nonsafety-related SSCs separated from a safety-related structure by a 

distance greater than the height of the nonsafety-related structure need 

not be designed for abnormal and extreme environmental load 

combinations.

Criteria for Nonsafety-Related SSCs in Safety-Related Structures

Nonsafety-related SSCs within safety-related structures (i.e., within the 

seismic boundary) are evaluated for II/I interaction. Seismic interaction 

effects to be considered include proximity, differential displacements, 

structural failure and falling, water spray or flood, and fire.

The applicant stated that depending on the type of component, non-safety-related SSCs 

categorized as II/I are evaluated or qualified using the following methods to demonstrate that 

they do not impact safety-related SSCs: 

(1) Detailed evaluation using structural analysis or consideration of seismic loading in the 

development of allowable spans and support configurations.

(2) Anchorage design and analysis to assure that the components do not interact with 

adjacent safety-related SSCs or become missiles during a seismic event.

(3) Qualitative evaluation using considerations such as weight to assess the potential 

impact on safety-related components (e.g., a lightweight object impacting a large 

diameter pipe, or a small bore pipe impacting the rugged casing of a pump).
Design of Structures, Systems, and Components

3-26

(4) Specifications for commodity or architectural items can include requirements for 

performance during a seismic event (e.g., cabinet door swing limits and lighting 

supports designed for seismic loads).

The staff finds the applicant’s response addresses how the applicant will meet the requirements 

in 10 CFR 50.34(a)(4) and demonstrates adequate design criteria for a preliminary design. The 

staff will confirm that the final design conforms to this design basis during the evaluation of 

SHINE’s FSAR.

SHINE PSAR Section 3.5.1 discusses the classification of SSCs. SHINE PSAR Section 3.5.1.1 

states in part, that “SHINE uses a modified definition from 10 CFR 50.2 to develop the definition 

of safety-related SSCs, where appropriate,” and utilizes a portion of 10 CFR 70.4 for the 

definition of IROFS SSCs.

In its responses to RAIs 3.5-1 and 3.5-4, the applicant proposed a six-part definition of 

safety-related SSCs, which modifies the 10 CFR 50.2 definition of safety-related SSCs to 

include performance requirements for SSCs important to safety in the SHINE facility, and 

eliminates the classification of certain SSCs as IROFS. While five of the six parts of this 

modified definition are performance-based, the fourth part of this definition (i.e., “[t]hat the 

potential for an inadvertent criticality accident is not credible”) is not performance-based.

Additional information was needed for the NRC staff to evaluate the adequacy of SHINE’s 

modified definition of safety-related SSCs. Furthermore, additional information was needed for 

the NRC staff to determine the relationship between the definition of a basic component in 

10 CFR 21.3 to SHINE’s proposed definition of safety-related SSCs. Additionally, the NRC staff 

notes that despite SHINE’s statement, this revised definition of safety-related SSCs eliminates 

the classification of certain SSCs as items relied on for safety, the term “IROFS” still appears in 

several places in the SHINE PSAR. Therefore, in RAI 3.5-6 (Reference 16), the staff asked that 

the applicant: 

(1) Provide a performance-based definition for the fourth part (i.e., with respect to 

the credibility of an inadvertent criticality accident) of the six-part definition of 

safety-related SSCs or provide a discussion of why it is not necessary; 

(2) Discuss how SHINE’s definition of safety-related SSCs relates to the 

10 CFR 21.3 definition of basic component (i.e., describe whether SHINE’s 

defined safety-related SSCs can also be considered basic components under 

10 CFR 21.3); and 

(3) Remove references to IROFS from the SHINE PSAR if there are no longer 

SSCs that will bear this designation, or clarify how IROFS will be utilized as 

part of SHINE’s ongoing safety basis.

In its response to RAI 3.5-6 (Reference 24), the applicant referred to the definition of 

safety-related SSCs that was provided in its response to RAI 3.5-1 regarding implementation of 

the requirements of 10 CFR 70.61(d). The applicant further stated that the fourth part of the 

definition of safety-related SSCs was updated to be performance-based and readily applicable 

to SSCs as follows: 

4. That all nuclear processes are subcritical, including use of an approved 

margin of subcriticality;
Design of Structures, Systems, and Components

3-27

The applicant also responded that it considers safety-related SSCs to be basic components, as 

defined in 10 CFR 21.3.

The applicant stated that the SSCs at the SHINE facility will not bear the classification of 

IROFS. PSAR Section 1.3.3, “Principal Design Criteria, Operating Characteristics, and Safety 

Systems,” inadvertently retains references to IROFS and the acronyms and abbreviations list for 

PSAR Chapter 14, “Technical Specifications,” inadvertently retains a definition for the IROFS 

acronym, which is not used elsewhere in the chapter. The applicant provided a revised PSAR 

to remove the inadvertent references to IROFS. However, PSAR Table 3.5b-1 will continue to 

refer to “items relied on for safety” in the context of a direct quotation from 10 CFR 70.64. The 

applicant stated that these items are referred to as safety-related SSCs. 

The staff finds that the response addresses how the applicant will use the aforementioned 

definitions from 10 CFR 50.2, 10 CFR 70.4, and 10 CFR 21.3, and demonstrates adequate 

design criteria for a preliminary design. The staff will confirm that the final design conforms to 

this design basis during the evaluation of SHINE’s FSAR.

In response to RAI 3.5-4, SHINE stated, in part, that the control room is part of a safety-related, 

Seismic Category I structure, but that the other SSCs are not defined as safety-related based on 

SHINE’s definition of safety-related SSCs.

While SHINE’s response to RAI 3.5-4 also states that safety-related systems are automatic and 

would put the facility in a safe condition without operator intervention, there is no discussion on 

how control room operators or other facility personnel will determine the facility is in a safe 

condition or how personnel will maintain the facility in a safe condition. Under the conditions of 

a postulated design-basis earthquake and a loss-of-offsite power (LOOP), the following 

conditions could exist which would inhibit facility personnel from determining that the facility is in 

a safe condition and maintaining the facility in a safe condition using necessary safety-related 

equipment:

• SHINE PSAR Tables 2.3-2 and 2.3-3 show that the outdoor temperature can vary 

between -37 degrees Fahrenheit (°F) and 104°F. While control room ventilation is 

supplied via FVZ4, which is non-safety-related, the control room has no heating, 

ventilation, and air conditioning (HVAC) system, which could impact control room 

habitability and equipment operability.

• The SHINE facility does not include emergency lighting, which could impact the ability of 

facility personnel to assess the facility status and to staff the control room.

• Since the stack release monitoring system is not defined as safety-related, its 

unavailability could impact the ability of facility personnel to determine that there are no 

releases going up the stack.

• Since the health physics monitors are not defined as safety-related, their unavailability 

could impact the ability of facility personnel to assess levels of contamination during 

egress from the facility.

• Since the facility data and communication system is not defined as safety-related, its 

unavailability could impact the ability of control room personnel to determine the facility 

status and communicate with other facility personnel and offsite agencies.
Design of Structures, Systems, and Components

3-28

• In the event of an earthquake, there is the possibility for both onsite and offsite toxic 

releases and smoke from fire. Since the facility breathing air system is not defined as 

safety-related, its unavailability could impact the ability of facility personnel to determine 

the facility status.

The staff also noted that additional information was needed on the design of the SHINE control 

room and other SSCs for the NRC staff to determine the adequacy of the design for the 

prevention of accidents and the mitigation of the consequences of accidents.

Therefore, in RAI 3.5-7 (Reference 16), the staff asked that the applicant provide additional 

information describing how the design of the SHINE control room and other SSCs will allow 

control room operators or other facility personnel to determine the facility is in a safe condition 

or how personnel will maintain the facility in a safe condition in the event of a postulated 

design-basis earthquake with a loss-of-offsite power.

In its response to RAI 3.5-7 (Reference 25), the applicant discussed how the facility is designed 

to be maintained in a safe configuration through the use of safety-related equipment during 

normal operations and as required to prevent or mitigate the consequences of abnormal 

operational transients or design basis accidents. 

The applicant stated that during the detailed design it will demonstrate that the control room will 

be within reasonable temperatures that will ensure safety-related equipment operability and that 

the control room operators can monitor plant conditions. The applicant will describe the method 

chosen to ensure the control room remains within a reasonable temperature range, and the 

reasonable temperature range will be defined in the FSAR.

The applicant stated that the control room will have access to information on the status of 

safety-related plant systems through the display and interface panels for the TSV reactivity 

protection system (TRPS) and radiological integrated control system (RICS), the engineered 

safety features actuation system (ESFAS) operator panel, the radiation monitor displays from 

the radiation area monitoring system (RAMS), the displays and alarms for the criticality accident 

alarm system (CAAS), and the neutron fluxes measured by the neutron flux detection system 

(NFDS) and relayed to the TRPS. These systems are safety-related and powered by the 

UPSS. These systems provide sufficient information to allow personnel in the control room to 

determine that the plant is in a safe condition and maintained in a safe condition.

The applicant described how the control room will have adequate lighting following a seismic 

event or loss of offsite power, which included 8 hours of battery backup power; charging 

capability by the standby diesel generator and normal electrical power supply system (NPSS); 

and, the availability of handheld lights. Additionally, the emergency lighting system (ELTG) was 

added to the systems list provided in PSAR Table 3.1-1. 

The applicant stated that, in addition to the monitoring of the plant conditions through the control 

room instrumentation, personnel will be able to assess releases through the facility stack. The 

primary means of monitoring the facility stack will be with the stack release monitoring (SRM) 

system. This system will provide monitoring of noble gases, aerosols, iodine, and tritium 

effluents. Although non-safety-related, SHINE will add the SRM system to the loads powered 

by the UPSS, and therefore the SRM system will likely be available after a loss of offsite power. 

The nominal connected load and the nominal demand load for the SRM system will be 

determined during detailed design. SHINE will update the UPSS load list provided in PSAR 

Table 8a2.2-1, “UPSS Load List,” in the FSAR to include the SRM system.
Design of Structures, Systems, and Components

3-29

The applicant stated that, as described in Section 7.2.3 of the SHINE Preliminary Emergency 

Plan, if the SRM system or health physics monitors become unavailable due to a design-basis 

earthquake or loss of offsite power, there will be other methods and equipment to perform the 

functions of those systems. These methods and equipment will be maintained by inventory and 

surveillances to ensure availability when required.

The applicant stated that the control room operators and other SHINE personnel will be able to 

communicate with each other and offsite agencies during a seismic event or loss of offsite 

power by having multiple independent communication subsystems available that use different 

technologies to ensure at least one method is available for onsite and offsite communication. 

The applicant stated that, as described in PSAR Section 13b.3, “Analysis of Accidents with 

Hazardous Chemicals Produced from Licensed Material,” potential chemical hazards from 

onsite chemicals associated with licensed materials have been evaluated, which included 

appropriate safety controls to prevent or mitigate the consequences to an acceptable level. 

Offsite chemical hazards have been evaluated in PSAR Section 2.2.3, “Analysis of Potential 

Accidents at Facilities,” and in the applicant’s response to RAI 2.2-3.

The applicant stated that fire areas in the SHINE IF and RPF are separated by three-hour rated 

fire barriers to prevent the spread of a fire throughout the facility. While one fire zone may 

become uninhabitable, the majority of the facility will not be affected. SHINE also has a 

diesel-driven fire pump, which is expected to be available following a loss of offsite power. The 

SHINE fire protection systems and programs are further described in PSAR Section 9a2.3, “Fire 

Protection Systems and Programs.”

The applicant stated the design of the control room and other SSCs will ensure that SHINE 

personnel can assess the safe condition of the facility and ensure that it is maintained in a safe 

shutdown condition following a design-basis earthquake or loss of offsite power.

The staff finds the applicant’s response addresses how it will meet the requirements in 

10 CFR 50.34(a)(4) and demonstrates adequate design criteria for a preliminary design. The 

staff will confirm that the final design conforms to this design basis during the evaluation of 

SHINE’s FSAR.

As required by 10 CFR 50.34(a)(4), an applicant needs to submit “[a] preliminary analysis and 

evaluation of the design and performance of structures, systems, and components of the facility 

with the objective of assessing the risk to public health and safety resulting from operation of the 

facility..., and the adequacy of structures, systems, and components provided for the prevention 

of accidents and the mitigation of the consequences of accidents.”

SHINE PSAR, Table 3.5b-1 (pages 3-102 - 3-106) under the first column, “Baseline Design 

Criteria 10 CFR 70.64,” lists the following criterion:

(7) Utility services. The design must provide for continued operation of 

essential utility services. 

Under the second table column, “As Applied to SHINE,” the stated applicability is: “As Applied 

and Means of Compliance - The SHINE facility provides a standby diesel generator for asset 

protection of selected systems. Refer to SHINE PSAR, Section 8b for detailed information.” 

The staff notes that while SHINE PSAR Table 3.5b-1 refers to PSAR Section 8b, PSAR Section 

8b essentially refers to PSAR Section 8a.
Design of Structures, Systems, and Components

3-30

However, this is classified as non-safety-related and does not have to function after a 

design-basis earthquake. In addition, SHINE PSAR Section 8a2.1.4, “SHINE Facility Loads 

Supported by SDG,” references Table 8a2.1-2, “Standby Diesel Generator Load List,” 

(Reference 36), but unlike PSAR Section 8a2.2.3, “SHINE Facility Systems Served by the Class 

1E UPSS,” which provides a list of what systems are supported by the Class 1E UPSS, it does 

not provide a list of systems supported by the standby diesel generator system.

Therefore, in RAI 3.5b-1 (Reference 14), the staff asked that the applicant provide a list of 

systems supported by the SDG and provide clarification on how Criterion 7, “Utility services,” of 

10 CFR 70.64 is met for the case of a postulated design-basis earthquake with a LOOP.

In its response to RAI 3.5b-1 (Reference 20), the applicant stated that the following systems are 

supported by the standby diesel generator: 

• Tritium purification system

• RVZ1, facility instrument air system

• Facility instrument air system

• FVZ4, emergency lighting system

• Emergency lighting system

• UPSS

• Radioactive drain system (RDS)

• Facility fire detection and suppression 

Additionally, the applicant stated that following are additional loads on the standby diesel 

generator that are not listed as systems in the PSAR: 

• Security system

• Freeze protection

• Raw material storage area heaters

• Emergency Operating Center

The applicant stated that during a loss of normal alternating current (AC) power, Criterion 7 of 

10 CFR 70.64 is met by the UPSS. The safety-related UPSS feeds two 120 volts – alternating 

current (VAC) UPSS Class 1E buses, which provide power to essential equipment and 

instrumentation. The systems served by the Class 1E UPSS are identified in PSAR 

Section 8a2.2.3. The UPSS is capable of delivering required emergency power for the required 

duration during normal and abnormal operation. The UPSS battery chargers associated with 

the UPSS Class 1E battery subsystem are connected to the bus fed by the standby diesel 

generator. The battery chargers provide the required isolation between the non-1E normal 

electrical power supply system and Class 1E 250 volts – direct current (VDC). The AC input 

breakers on both battery chargers and voltage regulating transformers are qualified as isolation 

devices using guidance from the IEEE 384, “IEEE Standard Criteria for Independence of 

Class 1E Equipment and Circuits.”

The staff finds that the response addresses how the applicant meets the requirements in 

10 CFR 50.34(a)(4) and demonstrates adequate design criteria for a preliminary design. The 

staff will confirm that the final design conforms to this design basis during the evaluation of 

SHINE’s FSAR.
Design of Structures, Systems, and Components

3-31

As required by 10 CFR 50.34(a)(4), an applicant needs to submit “[a] preliminary analysis and 

evaluation of the design and performance of structures, systems, and components of the facility 

with the objective of assessing the risk to public health and safety resulting from operation of the 

facility..., and the adequacy of structures, systems, and components provided for the prevention 

of accidents and the mitigation of the consequences of accidents.”

In response to RAI 3.5b-1, SHINE provided the information on the systems supported by the 

SDG, and stated that Criterion 7 of 10 CFR 70.64 is met by the uninterruptible power supply 

chain. The staff needed additional information to evaluate the SDG’s ability to meet Criterion 7 

of 10 CFR 70.64 to determine the adequacy of SSCs provided for the prevention of accidents 

and the mitigation of the consequences of accidents.

Therefore, in RAI 3.5b-2 (Reference 16), the staff asked that the applicant provide additional 

information stating how the standby diesel generator meets Criterion 7 of 10 CFR 70.64, given 

that it and the systems it powers are classified as non-safety-related and how the uninterruptible 

power supply chain meets Criterion 7 of 10 CFR 70.64 during a loss of normal AC power.

In its response to RAI 3.5b-2 (Reference 24), the applicant stated that PSAR Table 3.5b-1 

provides SHINE’s general evaluation of the design bases of the RPF against the baseline 

design criteria specified under 10 CFR 70.64 and general design criteria (GDC) 61, “Fuel 

Storage and Handling and Radioactivity Control”; 62, “Prevention of Criticality in Fuel Storage 

and Handling”; 63, “Monitoring Fuel and Waste Storage”; and 64, “Monitoring Radioactivity 

Releases”; of Appendix A to 10 CFR Part 50, as a good design practice. Criterion 7 of the 

baseline design criteria specified under 10 CFR 70.64 states, “[t]he design must provide for 

continued operation of essential utility services.” The applicant states that while the standby 

diesel generator provides an additional source of power should offsite power be lost, it is not 

safety-related and is not used to meet Criterion 7 of 10 CFR 70.64. The applicant stated that it 

plans to use the UPSS to power safety-related equipment should off-site power be lost and the 

SDG not be available. The UPSS provides continued operation of essential electrical utility 

service at the SHINE facility, and no other essential utilities are identified for the facility. The 

applicant revised the “As Applied and Means of Compliance” discussion provided for Criterion 7 

in PSAR Table 3.5b-1 in the PSAR to be consistent with the discussion provided for 

Criterion 17, “Electric power systems,” in PSAR Table 3.5a-1.

The staff finds that the response addresses how the applicant meets the requirements in 

10 CFR 50.34(a)(4) and demonstrates adequate design criteria for a preliminary design. The 

staff will confirm that the final design conforms to this design basis during the evaluation of 

SHINE’s FSAR.

On the basis of its review, the staff has determined that the level of detail provided on systems 

and components is adequate and supports the preliminary design and satisfies the applicable 

acceptance criteria of NUREG-1537, Part 2, Section 3.5. The staff concludes: (1) the design 

criteria included consideration of the conditions required of the SSCs to ensure safe facility 

operation, including response to transient and potential accident conditions analyzed in the 

PSAR; and (2) the design of the SSCs addressed the applicable baseline design criteria of 

10 CFR 70.64.

Therefore, the staff finds that the facility design features to cope with seismic damage are

sufficient and meet the applicable regulatory requirements and guidance for issuance of a 

construction permit in accordance with 10 CFR 50.35 and 50.40. Further technical or design 

information required to complete the safety analysis may reasonably be left for later 
Design of Structures, Systems, and Components

3-32

consideration. The staff will confirm that the final design conforms to this design basis during 

the evaluation of SHINE’s FSAR.

Summary and Conclusions

The staff evaluated the descriptions and discussions of the SHINE facility’s SSC design criteria, 

as described in Chapter 3 of the SHINE PSAR and supplemented by the applicant’s responses 

to RAIs, and finds that the preliminary design criteria of SHINE’s SSCs, including the principal 

design criteria; design bases; and information relative to materials of construction, general 

arrangement, and approximate dimensions: (1) provide reasonable assurance that the final 

design will conform to the design basis, and (2) meet applicable regulatory requirements and 

acceptance criteria in NUREG-1537 and the ISG augmenting NUREG-1537. 

On the basis of these findings, the staff has made the following conclusions for the issuance of 

a construction permit in accordance with 10 CFR 50.35 and 50.40:

(1) SHINE has described the proposed design criteria of SSCs, including, but not limited 

to, the principal architectural and engineering criteria for the design, and has identified 

the major features or components incorporated therein for the protection of the health 

and safety of the public.

(2) Further technical or design information required to complete the safety analysis of the 

SHINE SSCs may reasonably be left for later consideration in the FSAR.

(3) There is reasonable assurance that, taking into consideration the site criteria contained 

in 10 CFR Part 100, the proposed facility can be constructed and operated at the 

proposed location without undue risk to the health and safety of the public.

(4) There is reasonable assurance: (i) that the construction of the SHINE facility will not 

endanger the health and safety of the public, and (ii) that construction activities can be 

conducted in compliance with the Commission’s regulations.

(5) The issuance of a permit for the construction of the facility would not be inimical to the 

common defense and security or to the health and safety of the public.
4-1

IRRADIATION UNITS AND RADIOISOTOPE PRODUCTION 

FACILITY DESCRIPTION

The facility description addresses the principal features, operating characteristics, and 

parameters of the SHINE Medical Technologies, Inc. (SHINE or the applicant) irradiation units 

(IUs) (which constitute the irradiation facility [IF]) and radioisotope production facility (RPF). An 

IU is an accelerator-driven subcritical operating assembly used for the irradiation of an aqueous 

uranyl sulfate target solution, resulting in the production of molybdenum-99 (Mo-99) and other 

fission products. The primary function of the RPF is to extract, purify, package, and ship 

medical radioisotopes.

This chapter of the SHINE construction permit safety evaluation report (SER) describes the 

review and evaluation by the U.S. Nuclear Regulatory Commission (NRC) staff (the staff) of the 

preliminary design of the SHINE IUs and RPF as presented in Chapter 4, “Irradiation Unit and 

Radioisotope Production Facility Description,” of the SHINE Preliminary Safety Analysis Report 

(PSAR), as supplemented by the applicant’s response to the staff’s requests for additional 

information (RAIs).

4a Irradiation Unit

SER Section 4a, “Irradiation Unit,” provides an evaluation of the preliminary design of SHINE’s 

IU as presented in SHINE PSAR Section 4a2, “Irradiation Facility Description.”

4a.1 Areas of Review

The staff reviewed SHINE PSAR Section 4a2 against applicable regulatory requirements using 

regulatory guidance and standards to assess the sufficiency of the preliminary design and 

performance of the SHINE IU systems. As part of this review, the staff evaluated descriptions 

and discussions of the SHINE IF with special attention to design and operating characteristics, 

unusual or novel design features, and principal safety considerations. The preliminary design of 

the SHINE IU was evaluated to ensure the sufficiency of principal design criteria; design bases; 

and information relative to materials of construction, general arrangement, and approximate 

dimensions, sufficient to provide reasonable assurance that the final design will conform to the 

design basis. In addition, the staff reviewed SHINE’s identification and justification for the 

selection of those variables, conditions, or other items, which are determined to be probable 

subjects of technical specifications for the facility, with special attention given to those items 

which may significantly influence the final design.

Areas of review for this section included the subcritical assemblies, neutron drivers, target 

solution vessel (TSV) and light water pool, biological shield, nuclear design, thermal-hydraulic 

design, and gas management system. Within these review areas, the staff assessed the 

preliminary analysis of the target solution, reactivity control mechanisms, neutron moderator and 

reflector, subcritical multiplication source, subcritical assembly support structure (SASS), 

neutron multiplier, high voltage power supply (HVPS) accelerator, control systems, accelerator 

and differential pumping system, target chamber, normal operating conditions, reactor core 

physics parameter, operating limits, design bases, and heat removal systems.
Irradiation Units and Radioisotope Production Facility Description

4-2

4a.2 Summary of Application

The SHINE facility includes eight IUs and their supporting systems, which the IF comprises. 

Section 4a2 of the SHINE PSAR describes one of the eight IUs. The summary provided below 

applies to all eight IUs.

An IU is an accelerator-driven subcritical operating assembly used for the irradiation of an 

aqueous uranyl sulfate target solution, resulting in the production of Mo-99 and other fission 

products. An accelerator is used to create deuterium-tritium fusion reactions, resulting in the 

formation of high-energy neutrons, which cause various multiplying reactions in the neutron 

multiplier, which then increase the neutron population entering the TSV. The neutron population 

in the TSV leads to fissioning of the uranium solution. 

Each IU consists of a subcritical assembly (SCAS), neutron driver, TSV and light water pool, 

biological shield, and gas management system. The primary fission-product barriers of the IUs 

are the TSV, TSV off-gas management system (TOGS), and TSV dump tank. 

SHINE PSAR Section 4a2 provides the preliminary design of the SHINE IU systems, including 

physical descriptions, design bases, process functions and operation, safety functions, 

interfaces, and probable subjects of technical specifications. 

SHINE PSAR Section 4b, “Radioisotope Production Facility Description,” contains a summary 

description of the RPF. It describes the design of the RPF and the processes employed within 

it, and includes the principal safety considerations that were factored into the RPF design, 

construction, and operation. It also describes the RPF biological shield, the radioisotope 

extraction system, and the special nuclear material (SNM) processing and storage.

4a.3 Regulatory Basis and Acceptance Criteria

The staff reviewed SHINE PSAR Chapter 4 against applicable regulatory requirements, 

guidance, and standards, to assess the sufficiency of the preliminary design and performance of 

the SHINE IF and RPF for the issuance of a construction permit. In accordance with paragraph 

(a) of Title 10 of the Code of Federal Regulations (10 CFR) 50.35, “Issuance of construction 

permits,” a construction permit authorizing SHINE to proceed with construction may be issued 

once the following findings have been made:

(1) SHINE has described the proposed design of the facility, including, but not limited to, 

the principal architectural and engineering criteria for the design, and has identified the 

major features or components incorporated therein for the protection of the health and 

safety of the public.

(2) Such further technical or design information as may be required to complete the safety 

analysis, and which can reasonably be left for later consideration, will be supplied in 

the final safety analysis report (FSAR).

(3) Safety features or components, if any, which require research and development have 

been described by SHINE and a research and development program will be conducted 

that is reasonably designed to resolve any safety questions associated with such 

features or components.
Irradiation Units and Radioisotope Production Facility Description

4-3

(4) On the basis of the foregoing, there is reasonable assurance that: (i) such safety 

questions will be satisfactorily resolved at or before the latest date stated in the 

application for completion of construction of the proposed facility, and (ii) taking into 

consideration the site criteria contained in 10 CFR Part 100, “Reactor Site Criteria,” the 

proposed facility can be constructed and operated at the proposed location without 

undue risk to the health and safety of the public.

With respect to the last of these findings, the staff notes that the requirements of 

10 CFR Part 100 are specific to nuclear power reactors, and therefore not applicable to the 

SHINE facility. However, the staff evaluated SHINE’s site specific conditions using site criteria 

similar to 10 CFR Part 100, by using the guidance in NUREG-1537, Part 1, “Guidelines for 

Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Format and 

Content,” issued February 1996 (Reference 4) and Part 2, “Guidelines for Preparing and 

Reviewing Applications for the Licensing of Non-Power Reactors, Standard Review Plan and 

Acceptance Criteria,” issued February 1996 (Reference 5). The staff’s review evaluated the 

geography and demography of the site; nearby industrial, transportation, and military facilities; 

site meteorology; site hydrology; and site geology, seismology, and geotechnical engineering to 

ensure that issuance of the construction permit will not be inimical to public health and safety.

The staff’s evaluation of the preliminary design of the SHINE IF and RPF does not constitute 

approval of the safety of any design feature or specification. Such approval will be made 

following the evaluation of the final design of the SHINE IF as described in the FSAR as part of 

the SHINE operating license application.

4a.3.1 Applicable Regulatory Requirements

The applicable regulatory requirements for the evaluation of SHINE’s proposed IF and RPF are 

as follows:

• 10 CFR 50.23, “Construction permits.” 

• 10 CFR 50.34, “Contents of applications; technical information,” paragraph (a), 

“Preliminary safety analysis report.”

• 10 CFR 50.35, “Issuance of construction permits.” 

• 10 CFR 50.40, “Common standards.”

• 10 CFR 50.45, “Standards for construction permits, operating licenses, and combined 

licenses.” 

• 10 CFR 70.61, “Performance Requirements.”

4a.3.2 Regulatory Guidance and Acceptance Criteria

In applying guidance and acceptance criteria, the staff used its judgment as to which 

acceptance criteria were relevant to SHINE’s proposed facility, as much of this guidance was 

originally developed for nuclear reactors. Given the similarities in SHINE’s proposed facility and 

non-power research reactors, the staff used established guidance documents and the 
Irradiation Units and Radioisotope Production Facility Description

4-4

Commission’s regulations to determine the acceptance criteria for demonstrating compliance 

with 10 CFR regulatory requirements. For example, the staff used: 

• NUREG-1537, Part 1, “Guidelines for Preparing and Reviewing Applications for the 

Licensing of Non-Power Reactors, Format and Content,” issued February 1996 

(Reference 4).

• 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 (Reference 5).

• “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 (Reference 6).

• “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 (Reference 7).

As stated in the ISG Augmenting NUREG-1537, the staff determined that certain guidance 

originally developed for heterogeneous non-power research and test reactors is applicable to 

aqueous homogenous facilities and production facilities. SHINE used this guidance to inform 

the design of its facility and prepare its PSAR. The staff’s use of reactor-based guidance in its 

evaluation of the SHINE PSAR is consistent with the ISG Augmenting NUREG-1537.

As appropriate, additional guidance (e.g., NRC regulatory guides, Institute of Electrical and 

Electronics Engineers (IEEE) standards, American National Standards Institute/American 

Nuclear Society (ANSI/ANS) standards) has been used in the staff’s review of SHINE’s PSAR. 

The use of additional guidance is based on the technical judgment of the reviewer, as well as 

references in NUREG-1537, Parts 1 and 2; the ISG Augmenting NUREG-1537, Parts 1 and 2; 

and the SHINE PSAR. Additional guidance documents used to evaluate SHINE’s PSAR are 

provided as references in Appendix B of this SER.

4a.4 Review Procedures, Technical Evaluation, and Evaluation Findings

The staff performed an evaluation of the technical information presented in SHINE PSAR 

Section 4a2, as supplemented by the applicant’s responses to RAIs, to assess the sufficiency of 

the preliminary design and performance of SHINE’s IU for the issuance of a construction permit, 

in accordance with 10 CFR 50.35(a). The sufficiency of the preliminary design and performance 

of the SHINE IU is determined by ensuring the design and performance meet applicable 

regulatory requirements, guidance, and acceptance criteria, as discussed in Section 4a.3, 

“Regulatory Basis and Acceptance Criteria,” of this SER. A summary of the technical evaluation 

is described in SER Section 4a.5, “Summary and Conclusion.”

For the purposes of issuing a construction permit, the preliminary design of the SHINE IU may 

be adequately described at a functional or conceptual level. The staff evaluated the sufficiency 

of the preliminary design of the SHINE IU based on the applicant’s design methodology and 

ability to provide reasonable assurance that the final design will conform to the design bases 
Irradiation Units and Radioisotope Production Facility Description

4-5

with adequate margin for safety. As such, the staff’s evaluation of the preliminary design of the 

SHINE IU does not constitute approval of the safety of any design feature or specification. Such 

approval will be made following the evaluation of the final design of the SHINE IU, as described 

in the FSAR, as part of SHINE’s operating license application.

4a.4.1 Summary Description

The staff evaluated the sufficiency of the summary description of the IU, as described in SHINE 

PSAR Section 4a2.1, “Summary Description,” using the guidance and acceptance criteria from 

Section 4a2.1, “Summary Description,” of the ISG Augmenting NUREG-1537, Parts 1 and 2.

Section 4a2.1 of the ISG Augmenting NUREG-1537, Part 2, states that the summary description 

should contain a general overview of the design and important characteristics of operation. 

Based on the information provided in Section 4a2.1 of the SHINE PSAR, the staff finds that the 

summary description of the SHINE IU meets the acceptance criteria of the ISG Augmenting 

NUREG-1537 for the issuance of a construction permit in accordance with 10 CFR 50.35 and 

meets the standards in 10 CFR 50.40.

4a.4.2 Subcritical Assembly

The primary components that make up the SCAS are the TSV and the neutron multiplier, which 

are both supported and positioned by the SASS. The SCAS is submerged in a light water pool 

and located directly beneath the neutron driver assembly (NDAS). The SCAS and the NDAS 

are the primary components of the IU. The SCAS, light water pool, and NDAS are further 

described in SHINE PSAR Sections 4a2.2.5, “Reactor Internals Support Structures”; 4a2.4.2, 

“Light Water Pool”; and 4a2.3, “Neutron Driver”; respectively.

4a.4.3 Target Solution

The staff evaluated the sufficiency of target solution, as described in SHINE PSAR 

Section 4a2.2.1, “Target Solution,” using the guidance and acceptance criteria from 

Section 4a2.2.1, “Reactor Fuel,” of the ISG Augmenting NUREG-1537, Parts 1 and 2. The staff 

notes that, while the target solution is not considered reactor fuel, the target solution is similar in 

nature and behavior to the liquid fuel loading of an aqueous homogeneous reactor (AHR) and, 

therefore, the guidance in the ISG Augmenting NUREG-1537 can be applied.

Consistent with the review procedures of Section 4a2.2.1 of the ISG Augmenting NUREG-1537, 

Part 2, the staff considered whether the information provided adequately described required 

characteristics of the target solution.

As stated in SHINE PSAR Section 4a2.2.1, the target solution is a uranyl sulfate solution with an 

enrichment of 19.75 percent ± 0.2 percent. Uranium concentration is preliminary and subject to 

change until completion of the detailed design. Fuel solution of this composition has been 

analyzed in a number of different research programs, cited in SHINE PSAR Section 4a2.2.1.13, 

“Target Solution History.” Based on these analyses, the chemical and physical characteristics 

of fuel constituents should be compatible with one another. Each irradiation cycle is 5.5 days, 

with some makeup solution expected to be added between cycles to counter process losses. 

Target solution processing is further described in SHINE PSAR Section 4b2.4.1, “Methodology.” 
Irradiation Units and Radioisotope Production Facility Description

4-6

The primary system boundary (PSB) components were designed to be compatible with the 

target solution to avoid corrosion and other unwanted metallurgical effects that could 

compromise the PSB integrity.

Mixing in the TSV takes place by natural convection. The highest heat generation will occur 

near the center of the solution, and the surfaces adjacent to cooling flow will be the coolest. 

Thus, there will be an upward flow through the center of the TSV and a downward flow near the 

cooled surfaces. Detailed analyses of heat generation and cooling flow will be provided in the 

FSAR. 

Non-uniformities, such as non-uniform void distribution, non-uniform temperatures, and 

non-uniform power distribution, are not expected to impact operational limits.

Off-gas formation is handled by the TOGS, as described in SHINE PSAR Section 4a2.8, “Gas 

Management System.” Preliminary calculations indicate that plutonium and poison buildup, 

along with changes in pH, will not be significant. The solution will also be processed through 

the molybdenum extraction and purification system (MEPS) after each irradiation cycle, and 

through the uranyl nitrate conversion system (UNCS) and the uranium extraction (UREX) 

system after a specified number of irradiation cycles. This processing sequence does not result 

in any long-term chemical or physical consequences to the target solution according to research 

conducted at Argonne National Laboratory (ANL) (ANL 2012). 

The ISG Augmenting NUREG-1537, Part 2, Section 4a2.2.1, “Reactor Fuel,” “Acceptance 

Criteria,” states, in part, that the PSAR should include a description of the “various phenomena 

that result in changes to the initial fuel composition...including potential fuel and fission product 

precipitation....” 

SHINE PSAR Section 4a2.2.1.6, “TSV Operating Conditions,” states that there is no 

precipitation out of the target solution; however, International Atomic Energy Agency (IAEA) 

TECDOC-1601, “Homogeneous Aqueous Solution Nuclear Reactors for the Production of 

Mo-99 [Molybdenum-99] and Other Short Lived Radioisotopes,” states that as the fuel solution 

ages, fission products can approach solubility limits.

Therefore, in RAI 4a2.2-5 (Reference 14), because fuel solution concerns are similar to those 

for SHINE’s target solution, the staff asked the applicant to provide information on how close the 

SHINE target solution will be to the solubility limits and to provide additional information 

discussing whether SHINE plans to use catalytic agents to mitigate precipitation, as discussed 

in SHINE PSAR Section 4a2.4.1.1, “Design Considerations.”

In response to RAI 4a2.2-5 (Reference 21), the applicant stated that, as specified in 

Table 4a2.2-1, “Target Solution Chemical and Physical Properties,” of the PSAR, a catalytic 

agent will be used in the target solution but there are no plans to use catalytic agents to mitigate 

fission product precipitation because the small amount of potential precipitation is expected to 

have an insignificant effect on reactivity in the TSV. The applicant also stated that 

Table 4a2.2-1 of the PSAR will be updated with potential fission products precipitate levels and

that the details of the system design to remove the precipitates from the target solution during 

processing (e.g., filter with differential pressure monitoring) will be provided in the FSAR. 
Irradiation Units and Radioisotope Production Facility Description

4-7

The staff finds this response satisfies the acceptance criteria of ISG Augmenting NUREG-1537, 

Section 4a2.2.1, and demonstrates adequate design criteria for a preliminary design. The staff 

will confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR. 

The ISG Augmenting NUREG-1537, Part 2, Section 4a2.2.1 “Acceptance Criteria,” states, in 

part that the PSAR should include information on fuel operating parameters, taking into 

consideration “characteristics that could limit fuel barrier integrity.” This should include 

temperature ranges during startup and normal operation. In RAI 4a2.2-6 (Reference 14), the 

staff asked the applicant to provide the normal temperature range for startup and approach to 

criticality.

In response to RAI 4a2.2-6 (Reference 20), the applicant responded that during startup and 

approach to criticality, the TSV is expected to be at approximately the same temperature as the 

primary closed loop cooling system (PCLS), nominally 68 degrees Fahrenheit (°F), due to the 

small amount of decay heat generation in the target solution and the negligible fission power 

generated during startup. 

The staff finds this response satisfies the acceptance criteria of ISG Augmenting NUREG-1537, 

Section 4a2.2.1 and demonstrates adequate design criteria for a preliminary design. The staff 

will confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR. 

The ISG Augmenting NUREG-1537, Part 2, Section 4a2.2.1 states, in part, that the PSAR 

should include information on fuel operating parameters, taking into consideration 

“characteristics that could limit fuel barrier integrity.” This should include irradiation times and 

burnup. In RAI 4a2.2-7 (Reference 14), the staff asked the applicant to provide the duration of 

the “short irradiation cycle” mentioned in SHINE PSAR Section 4a2.2.1.9, “Chemical and 

Physical Changes in Target Solution,” and the maximum expected burnup.

In response to RAI 4a2.2-7 (Reference 20), the applicant stated that an individual irradiation 

cycle is approximately 5.5 days, and the maximum expected target solution burnup is 0.55 

percent of the initial heavy atoms (mainly uranium-235 [U-235] and uranium-238 [U-238]), which 

would occur after approximately 5 years of operation at maximum power with no target solution 

makeup.

The staff finds this response satisfies the acceptance criteria of ISG Augmenting NUREG-1537, 

Section 4a2.2.1 and demonstrates adequate design criteria for a preliminary design. The staff 

will confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR. 

The ISG Augmenting NUREG-1537, Part 2, Section 4a2.2.1 “Acceptance Criteria,” states, in 

part, that “maintaining fuel barrier integrity should be the most important design objective.” 

SHINE PSAR Section 4a2.2.1.10, “TSV Physical Structure,” mentions a “credible deflagration.” 

A strong deflagration or detonation could compromise the integrity of the primary system 

boundary. In RAI 4a2.2-8 (Reference 14), the staff asked that the applicant provide the 

pressure expected during a “credible deflagration,” and discuss how this value was determined, 

as well as how it compares to the maximum pressure that each component of the primary 

system boundary can withstand.
Irradiation Units and Radioisotope Production Facility Description

4-8

In response to RAI 4a2.2-8 (Reference 21), the applicant stated, in part, that “preliminary 

calculations indicate that the maximum pressure during a credible deflagration is less than 

50 pounds per square inch gauge (psig) and the maximum pressure during a credible 

deflagration was determined by investigating possible modes of failure of the TOGS...the 

calculated peak hydrogen concentration will be below the detonation limit. The deflagration 

pressure was calculated using an adiabatic flame temperature approach, adjusted for constant 

volume conditions, at the point of peak hydrogen concentration.” The applicant committed to 

ensure that the design pressure of each component of the PSB will be greater than the credible 

deflagration pressure determined in the final calculations, which will be performed during 

detailed design. 

The staff finds this response satisfies the acceptance criteria of ISG Augmenting NUREG-1537, 

Section 4a2.2.1 and demonstrates adequate design criteria for a preliminary design. The staff 

will confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

The ISG Augmenting NUREG-1537, Part 2, Section 4a2.2.1 “Acceptance Criteria,” states, in 

part, that the application should provide a summary of the “fuel development, qualification, and 

production program.” This should include discussions on fuel characterization, provide 

information on radiolytic gas production, changes in pH, gas removal, and addition of fuel and 

acid to the vessel along with implications on reactivity.

SHINE PSAR Section 4a2.2.1.13 briefly describes some of the history of uranyl sulfate 

development, but does not describe SHINE’s Target Solution Qualification Program. In RAI 

4a2.2-9 (Reference 14), the staff asked that the applicant provide a description of SHINE’s 

Target Solution Qualification Program, including specific historical target solution data and their 

origin (references) that have been used for validation and safety calculations presented in the 

current SHINE PSAR and to include tests, experiments, and analyses that will be (or have 

been) performed to validate the historical data.

In response to RAI 4a2.2-9, (Reference 21), the applicant provided the SHINE Target Solution 

Qualification Program which contains historical target solution data, the means to produce the 

target solution, an overview of the processes to which the target solution is exposed, limits to 

ensure safe and reliable target solution performance, and the tests and experiments that will be 

and have been performed to validate the target solution characteristics. 

The staff finds this response satisfies the acceptance criteria of ISG Augmenting NUREG-1537, 

Section 4a2.2.1 and demonstrates adequate design criteria for a preliminary design. The staff 

will confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

On the basis of its review, the staff has determined that the level of detail provided on the target 

solution is adequate and supports the preliminary design and satisfied the applicable 

acceptance criteria of NUREG-1537, Part 2, Section 4a2.2.1, allowing the staff to make the 

following relevant findings: (1) the target solution has been described in detail, including design 

limits and bases; (2) the constituents, materials, components, and preparation specifications 

have been appropriately described; (3) the target solution development history has been 

appropriately referenced and described; (4) the information provided on the target solution 

provides reasonable assurance that the fuel can function safely in the TSV without adversely 

affecting the health and safety of the public.
Irradiation Units and Radioisotope Production Facility Description

4-9

Therefore, the staff finds that the information provided on the target solution is sufficient and 

meets the applicable regulatory requirements and guidance for issuance of a construction 

permit in accordance with 10 CFR 50.35.

4a.4.4 Reactivity Control Mechanisms

The staff evaluated the sufficiency of reactivity control mechanisms, as described in SHINE 

PSAR Section 4a2.2.2, “Reactivity Control Mechanisms,” using the guidance and acceptance 

criteria from Section 4a2.2.2, “Control Rods,” of the ISG Augmenting NUREG-1537, Parts 1 

and 2. The staff notes that, while the applicant does not propose to use control rods, the basis 

and underlying principles of the guidance in ISG Augmenting NUREG-1537 can still be applied 

to the proposed reactivity control mechanisms.

Consistent with the review procedures of Section 4a2.2.2 of the ISG Augmenting NUREG-1537, 

Part 2, the staff considered whether the design bases provided adequately define all essential 

characteristics needed for reactivity control. 

According to SHINE PSAR Section 4a2.2.2, the IU is not intended to achieve criticality during 

normal operation, so no control rods are included in the SHINE design. Reactivity is determined 

by seven variables: uranium concentration in the target solution, uranium enrichment, TSV 

fill-volume, target solution temperature, target solution pressure, temperature of the light water 

pool, and temperature of the PCLS. During operation, the last four can be manipulated to 

control reactivity, while the others are generally not altered. The systems used to control 

system reactivity are described in detail in SHINE PSAR Section 7a2.4, “TSV Reactivity 

Protection System,” and Chapter 7, “Instrument and Control Systems,” of this SER, has an 

in-depth evaluation of SHINE’s IU reactivity control systems and engineered safety features 

actuation system.

When an abnormal condition arises that requires the IU to be shut down (e.g., loss of power, 

high flux, high hydrogen concentration), the control system of the neutron driver assembly will 

shut down the accelerator and terminate the reaction, as discussed in SHINE PSAR 

Section 4a2.3. The target solution can also be drained into criticality-safe dump tanks, as 

discussed in SHINE PSAR Section 4a2.4.1, “Target Solution Vessel.”

On the basis of its review, the staff has determined that the level of detail provided on the 

reactivity control mechanisms is adequate and supports the preliminary design and satisfied the 

applicable acceptance criteria of NUREG-1537, Part 2, Section 4a2.2.2, allowing the staff to 

make the following relevant findings: (1) the control and safety systems have been sufficiently 

described and design bases discussed; (2) function and safety-related design bases can be 

achieved by the control and safety system designs; (3) the design descriptions of components 

and materials offer reasonable assurance that these can control and shut down the IU safely 

from any operating condition; and (4) the criticality-safe design of the TSV dump tank should 

ensure an acceptable shutdown reactivity and margin.

Therefore, the staff finds that the information provided on the reactivity control mechanisms is 

sufficient and meets the applicable regulatory requirements and guidance for issuance of a 

construction permit in accordance with 10 CFR 50.35 and 50.40.
Irradiation Units and Radioisotope Production Facility Description

4-10

4a.4.5 Solid Neutron Moderator and Reflector

The staff evaluated the sufficiency of solid neutron moderators and reflectors, as described in 

SHINE PSAR Section 4a2.2.3, “Neutron Moderator and Reflector,” using the guidance and 

acceptance criteria from Section 4a2.2.3, “Solid Neutron Moderator and Reflector,” of the ISG 

Augmenting NUREG-1537, Parts 1 and 2. 

Consistent with the review procedures of Section 4a2.2.3 of the ISG Augmenting NUREG-1537, 

Part 2, the staff considered whether the information on the solid neutron moderators and 

reflectors adequately define all essential characteristics and discuss the required systems. 

SHINE PSAR Section 4a2.2.3 states the neutron multiplier is an aluminum-clad annulus of 

material that serves to improve the neutron population in the TSV. The design features of the 

multiplier are described in SHINE PSAR Section 4a2.2.6, “Neutron Multiplier.” A review of the 

neutron multiplier can be found later in Section 4a.4.8 of this SER. SHINE PSAR 

Section 4a2.2.3 also states no additional solid neutron moderators or reflectors are included in 

the design.

The applicant also states that the light water pool, which surrounds the TSV, provides liquid 

neutron moderation and reflection, as described in SHINE PSAR Section 4a2.4, “Target 

Solution Vessel and Light Water Pool.” A review of the light water pool can be found later in 

Section 4a.4.10, “Target Solution Vessel and Light Water Pool.”

The staff notes that the applicant provided information on design features that, based on their 

function or form, are not solid neutron moderators or reflectors (e.g., graphite) as described in 

the guidance.

The staff has considered the information provided in the PSAR and verified that no solid 

moderators or reflectors are included in the design. Therefore, the staff finds that the 

information provided on neutron moderators and reflectors is sufficient for issuance of a 

construction permit in accordance with 10 CFR 50.35.

4a.4.6 Subcritical Multiplication Source

The staff evaluated the sufficiency of the subcritical multiplication source, as described in 

SHINE PSAR Section 4a2.2.4, “Subcritical Multiplication Source,” using the guidance and 

acceptance criteria from Section 4a2.2.4, “Neutron Startup Source,” of the ISG Augmenting 

NUREG-1537, Parts 1 and 2. 

Consistent with the review procedures of Section 4a2.2.4 of the ISG Augmenting NUREG-1537, 

Part 2, the staff considered whether the information on the subcritical multiplication source 

adequately defines all components and functions.

SHINE PSAR Section 4a2.2.4 describes the subcritical multiplication source as a fixed neutron 

source that is used to monitor reactivity when the neutron driver is not operating. Its output is 

several orders of magnitude less than the neutron driver and is more suitable for performing 

measurements and inverse subcritical multiplication factor (1/M) plots during startup. This 

allows for accurate and reliable measurement of changes in neutron population while filling the 

TSV with target solution. 
Irradiation Units and Radioisotope Production Facility Description

4-11

Specif ic details of the subcritical multiplication source will be provided in the applicant’s FSAR. 

The staff will confirm that the final design conforms to this design basis during the evaluation of 

SHINE’s FSAR.

While the details of the SHINE subcritical multiplication source is not needed to issue a 

construction permit, the staff finds that the applicant’s identification in the PSAR of requiring a 

neutron source for the final design is appropriate. 

Therefore, the staff finds that the information provided on the subcritical multiplication source is 

sufficient and meets the applicable regulatory requirements and guidance for issuance of a 

construction permit in accordance with 10 CFR 50.35.

4a.4.7 Subcritical Assembly Support Structures

The staff evaluated the sufficiency of the SASS, as described in SHINE PSAR Section 4a2.2.5, 

“Subcritical Assembly Support Structure,” using the guidance and acceptance criteria from 

Section 4a2.2.5, “Reactor Internals Support Structures,” of the ISG Augmenting NUREG-1537, 

Parts 1 and 2. 

Consistent with the review procedures of Section 4a2.2.5 of the ISG Augmenting NUREG-1537, 

Part 2, the staff considered whether the information adequately defines a complete support 

system.

SHINE PSAR Section 4a2.2.5 states the SASS maintains the location and shape of the 

aqueous target solution during irradiation. It contains the TSV and supports the TSV dump 

lines, TSV overflow lines, TOGS piping, and associated instrumentation. The SASS also 

functions to force coolant through the cooling paths and acts as an additional fission product 

barrier in the event of a TSV failure. The SASS is designed to conservatively hold the weight of 

all design basis loads, including thermal, seismic, and hydrodynamic loads imposed by the light 

water pool during a seismic event. It is also designed to withstand all thermal and hydraulic 

forces imposed by the coolant loop and target solution. The SASS is operated at pressures 

near atmospheric (a slight pressure differential is required across the SASS to provide cooling 

water flow). The SASS is designed for an internal pressure of 100 pounds per square inch (psi) 

to accommodate forces resulting from a hydrogen deflagration event followed by a failure of the 

TSV integrity. The materials used to construct the SASS are chosen due to their compatibility 

with the chemical environment and demonstrated performance under a neutron flux. 

On the basis of its review, the staff has determined that the level of detail provided on the SASS 

is adequate and supports the preliminary design and satisfied the applicable acceptance criteria 

of NUREG-1537, Part 2, Section 4a2.2.5, allowing the staff to make the following relevant 

findings: (1) the support structure design should hold the weight of all core-related components; 

(2) the support structure design should withstand external forces and effects; and, (3) the 

support structure design should not cause malfunctions or interfere with safe operation or 

shutdown. The staff will confirm that the final design conforms to this design basis during the 

evaluation of SHINE’s FSAR.

Therefore, the staff finds that the information provided on the SASS is sufficient and meets the 

applicable regulatory requirements and guidance for issuance of a construction permit in 

accordance with 10 CFR 50.35.
Irradiation Units and Radioisotope Production Facility Description

4-12

4a.4.8 Neutron Multiplier

The staff evaluated the sufficiency of the neutron multiplier, as described in SHINE PSAR 

Section 4a2.2.6, “Neutron Multiplier.” While the ISG Augmenting NUREG-1537 does not have a 

section dedicated to the neutron multiplier, which is unique to SHINE, the staff assessed 

whether SHINE provided information that satisfies the requirements of 10 CFR 50.34(a)(4).

SHINE PSAR Section 4a2.2.6 states the neutron multiplier is located in the space between the 

neutron driver tritium target chamber and the TSV. It is an annulus of aluminum-clad material 

that moderates and multiplies the fast neutrons from the fusion reactions initiated by the neutron 

driver. Heat deposited in the multiplier is removed by the light water pool system (LWPS). The 

temperature profiles through the multiplier will be determined during detailed design, with 

appropriate design features included to address any thermal expansion and contraction 

expected to occur. Its design lifetime is 30 years, but can be removed and replaced if damaged. 

The construction materials for the proposed design are compatible with the chemical and 

radiation environment. SHINE PSAR Section 4a2.2.6 states that in the event of a cladding 

failure, there are no consequences that would affect the safe operation and shutdown of the 

irradiation system and that a breach of the aluminum cladding will be detected by sampling of 

the LWPS. Contaminated water can be sent for processing via the UNCS. 

The applicant states that the FSAR will contain a more comprehensive description of the 

manufacturing techniques and final dimensions for the neutron multiplier. The staff will confirm 

that the final design conforms to this design basis during the evaluation of SHINE’s FSAR.

While the details of the SHINE neutron driver is not needed to issue a construction permit, the 

staff finds that the applicant’s discussion on the neutron driver is appropriate and provides a 

sufficient level of detail for a PSAR. 

Therefore, the staff finds that the information provided on the neutron multiplier is sufficient and 

meets the applicable regulatory requirements for issuance of a construction permit in 

accordance with 10 CFR 50.35.

4a.4.9 Neutron Driver

The staff evaluated the sufficiency of the NDAS, as described in SHINE PSAR Section 4a2.3. 

While the ISG Augmenting NUREG-1537 does not have a section dedicated to the neutron 

multiplier, which is unique to SHINE, the staff assessed whether SHINE provided information 

that satisfies the requirements of 10 CFR 50.34(a)(4).

SHINE PSAR Section 4a2.3 states the NDAS is an accelerator-driven system that produces 

14 million electron volts (MeV) neutrons via deuterium-tritium fusion reactions. The NDAS is the 

source of neutrons used to generate the neutron fluxes required to create medical radioisotopes

in the TSV, which holds the target solution. These high-energy neutrons enter the target 

solution initiating the resulting subcritical fission reactions. The NDAS is situated above the 

SCAS and mounted to an operating platform attached to the cell wall. The NDAS consists of 

the neutron driver, HVPS, and a control cabinet.

While the ISG Augmenting NUREG-1537 does not have a section on NDAS, which is unique to 

SHINE, the staff assessed that in alignment with 10 CFR 50.34(a)(4), which requires a 

“preliminary analysis and evaluation of the design and performance of structures, systems, and 

components of the facility with the objective of assessing the risk to public health and safety 
Irradiation Units and Radioisotope Production Facility Description

4-13

resulting from operation of the facility..., and the adequacy of structures, systems, and 

components provided for the prevention of accidents and the mitigation of the consequences of 

accidents.” Consistent with 10 CFR 50.34(a)(4), the PSAR should include information regarding 

corrosion control, susceptibility to radiation damage, and the physical description, including 

materials and physical dimensions.

Therefore, in RAI 4a2.3-1 (Reference 14), the staff asked that the applicant provide the physical 

characteristics of the NDAS (e.g., construction materials, dimensions), provide the expected 

activity of the NDAS due to activation of its components at the end of one irradiation cycle and 

at the end of its expected life, and describe what radiation damage concerns there are for 

affected materials and components.

In response to RAI 4a2.3-1 (Reference 20), the applicant provided a preliminary design with the 

description of the materials and dimensions of the NDAS. In addition, the applicant stated that 

the materials or components of the NDAS do not have radiation damage concerns. Materials 

known to have unacceptably low radiation damage thresholds, such as Teflon, will not be used 

in the NDAS which will be made from materials suitable for the expected neutron fluence levels. 

The applicant also stated that the operational lifetime of the NDAS is expected to impact the 

neutron activation of its components at disposal. Approximately 90 percent of the activity 

resulting from activation will be located beneath the pool surface. It is expected that most 

NDAS components will not experience significant radiation damage. Complex electronic 

components will be located outside the IU.

The staff finds this response provided sufficient information to meet the requirements in 

10 CFR 50.34(a)(4) and demonstrates adequate design criteria for a preliminary design. The 

staff will confirm that the final design conforms to this design basis during the evaluation of 

SHINE’s FSAR.

SHINE PSAR Section 4a2.3.3, “Ion Source,” states the 300-kilovolt (kV) HVPS provides voltage 

to the accelerator. The HVPS is controlled via the NDAS control system, as described in 

SHINE PSAR Section 4a2.3.2, “Control System,” and shuts down on an overvoltage greater 

than 320 kV (this is a protective feature and not a safety limit or function). The NDAS control 

system provides the means to energize, monitor, and change NDAS components. 

SHINE PSAR Sections 4a2.3.3, “Ion Source,” 4a2.3.4, “Accelerator,” 4a2.3.5, “Focus Element,” 

4a2.3.6, “Differential Pumping,” and 4a2.3.7, “Target Chamber,” depicts the ion source, 

accelerator, focus element, target chamber, and the three differential pumping stages in the 

NDAS. A schematic is also provided in SHINE PSAR Figure 4a2.3-3, “Schematic of the 

Differential Pumping System as Built at PNL.” Deuterium ions are fed via an ion extractor from 

the ion source to the accelerator. The HVPS powers the 300-kV accelerator, which accelerates 

the ions towards the focus element. The differential pumping stages maintain the pressure 

differential between the accelerator and the target chamber. The target chamber is maintained 

at low pressure and is where the bulk of the deuterium-tritium interactions that drive the 

subcritical reaction occur.

Due to the high voltage involved with the accelerator, there is potential for electromagnetic 

interference. To mitigate this, NDAS components that are exposed to potential electromagnetic 

interference from the accelerator are shielded or otherwise electrically isolated. Other 

components near the accelerator will be similarly shielded. The beam of accelerated ions will 

diverge in the absence of the focusing element. Any failure of the focus element will result in a 

drop in neutron yield. The target chamber is maintained at low pressure and filled with tritium 
Irradiation Units and Radioisotope Production Facility Description

4-14

gas. Neutron yield is typically determined by the purity of the tritium in the chamber, which is 

controlled via the tritium purification system. The ion beam is fully stopped in the chamber 

during normal operation, so any increase in pressure will not change the yield and a sufficient 

decrease in pressure will decrease the yield. The target chamber is surrounded by the SCAS 

and is therefore subject to high neutron flux. The construction materials were chosen to 

mitigate the effects of corrosion and neutron damage. 

SHINE PSAR Section 4a2.3.8, “Process Control Requirements,” states that the TSV process 

control system (TPCS) and TSV reactivity protection system (TRPS) interface with the NDAS 

control system and will trigger the shutdown of the HVPS via safety-related trip circuitry in the 

event of abnormal conditions.

On the basis of its review, the staff has determined that the level of detail provided on the NDAS 

demonstrates an adequate design basis for preliminary design and are sufficient to ensure the 

protection of the public and minimize danger to life or property, consistent with 10 CFR 50.34,

50.35, and 50.40. Failure of any component of the NDAS will result in a conservative, lower flux 

state.

Therefore, the staff finds that the information provided on the NDAS is sufficient and meets the 

applicable regulatory requirements for issuance of a construction permit in accordance with 

10 CFR 50.35 and 50.40.

4a.4.10 Target Solution Vessel and Light Water Pool

The staff evaluated the sufficiency of the TSV and light water pool, as described in SHINE 

PSAR Section 4a2.4. While the ISG Augmenting NUREG-1537 does not have a section 

dedicated to the target solution vessel, which is unique to SHINE, the staff assessed whether 

SHINE provided information that satisfies the requirements of 10 CFR 50.34(a)(4).

The TSV is part of the PSB, which comprises the TSV, the TSV dump tank, and the TOGS. The 

TOGS is described in SHINE PSAR Section 4a2.8. The light-water pool serves multiple 

functions, including heat removal and radiological shielding. 

SHINE PSAR Section 4a2.4.1 describes the physical characteristics of the TSV, including the 

physical dimensions of the TSV and supporting structures. The SHINE PSAR also states that 

the TSV is designed and fabricated following the intent of the American Society of Mechanical 

Engineers (ASME) Boiler and Pressure Vessel Code (BPVC), Section III. Ongoing research at 

Oak Ridge National Laboratory (ORNL) is intended to determine whether the TSV design, 

fabrication process, and construction materials satisfy the requirements described in the code.

In response to RAI 4a2.4-1 (Reference 14), which asked the applicant to provide a discussion of 

the applicable ASME Code and discuss the features of the SHINE design that prevent 

application of the code as written, the applicant responded (Reference 21) that although the 

TSV will be designed and fabricated following the intent of the ASME BPVC, Section III, the 

TSV will not be certified to Section III of the ASME BPVC because its fabrication material is not 

included in ASME BPVC Section II. The applicant added that the results from the irradiation 

and corrosion testing being performed at ORNL will inform the final design of the TSV, which it 

plans to describe in detail in the SHINE FSAR. The results of the testing at ORNL will also 

verify that the stress intensity encountered by the TSV under design loadings during the design 

lifetime does not exceed the allowable stresses of the TSV material, including postulated 

accident loadings, which will be factored into the TSV design parameters.
Irradiation Units and Radioisotope Production Facility Description

4-15

The staff finds this response provided sufficient clarification regarding application of ASME 

BPVC, Section III, and demonstrates adequate design criteria for a preliminary design. The 

staff will confirm that the final design conforms to this design basis during the evaluation of the 

SHINE FSAR.

SHINE PSAR Section 4a2.4.1.5, “Chemical Interactions and Neutron Damage,” states that a 

materials surveillance and inspection program for the TSV and other PSB components will be 

described in the FSAR. In RAI 4a2.4-2 (Reference 14), the staff asked that the applicant 

provide a list of surveillance and inspection requirements, as well as information to show that 

the design will allow the required periodic surveillance and inspections to be performed.

In response to RAI 4a2.4-2, (Reference 21), the applicant committed to provide surveillance and 

inspection capabilities for these components to assess mechanical integrity and to verify that 

corrosion rates are acceptable. 

The staff finds this response provides a commitment to provide surveillance and inspection 

capabilities, and demonstrates adequate design criteria for a preliminary design. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

SHINE PSAR Section 4a2.4.2 states that the TSV will be located inside the light water pool, with 

the top of the TSV 6 feet below the water’s surface. It will be constructed from concrete and 

lined with stainless steel and is designed to withstand the chemical environment of the target 

solution.

SHINE PSAR Section 4a2.4.2.1, “Design of Light Water Pool,” states that the steel liner of the 

light water pool is designed to withstand the chemical environment of the target solution in the 

event of a breach that leaks target solution into the pool. However, the staff is concerned that 

any accumulation or plateout of fission products occurring on the liner surfaces (including 

corners, imperfections on weld points, etc.) could lead to increased local dose rates that might 

challenge the limits in 10 CFR Part 20, “Standards for Protection Against Radiation.” 

Therefore, in RAI 4a2.4-3 (Reference 14), the staff asked that the applicant provide information 

discussing whether the design characteristics of the pool liner preclude any accumulation or 

plateout of fission products that could challenge the limits in 10 CFR Part 20.

In response to RAI 4a2.4-3 (Reference 20), the applicant stated, in part, that under normal 

operating conditions, the target solution does not come in contact with the light water pool or the 

light water pool steel liner. The target solution is located inside the PSB, which consists of the 

TSV, the TOGS, and the TSV dump tank. As described in PSAR Section 4a2.2.1.4, “Primary 

System Boundary,” the PSB components are designed to be compatible with the target solution 

to avoid corrosion and other unwanted metallurgical effects that could lead to compromising the

PSB. Additionally, the TSV is located within the SASS pressure boundary. The SASS, along 

with the PCLS, provides another barrier between the target solution and the light water pool, 

should a leak in the TSV develop. The closed loop design of the PCLS prevents the 

commingling of the PCLS coolant with the water in the light water pool. In the event of a breach 

in which the target solution leaks into the light water pool, the IU cell where the leak is occurring 

would be shut down. The UNCS may then be used to process the contents of the light water 

pool by separating out the uranium and passing the contaminated water on for downstream 

processing. The IU cell would then be decontaminated by wash downs or other suitable means, 

as needed.
Irradiation Units and Radioisotope Production Facility Description

4-16

The staff finds this response provides sufficient information on the TSV, SASS pressure 

boundary, and pool liner design criteria, and demonstrates adequate design criteria for a 

preliminary design. The staff will confirm that the final design conforms to this design basis

during the evaluation of SHINE’s FSAR.

On the basis of its review, the staff has determined that the level of detail provided on the TSV 

and the light water pool demonstrates an adequate design basis for preliminary design and 

satisfies the applicable acceptance criteria of the ISG Augmenting NUREG-1537, Part 2. The 

staff finds that the applicant’s description of the TSV and light water pool, including operating 

limits and operating conditions, is adequate and sufficient to ensure the protection of the public 

and minimize danger to life or property, consistent with 10 CFR 50.34, 50.35, and 50.40. The 

SCAS is conservatively designed to fail to a safe, non-critical geometry and its components are 

adequately designed to withstand operational and credible accidents in the environment. The 

light water pool provides cooling to the TSV and provides an additional layer of protection 

against radiation damage for local components.

Therefore, the staff finds that the information provided on the TSV and light water pool is 

sufficient and meets the applicable regulatory requirements for issuance of a construction permit 

in accordance with 10 CFR 50.35.

4a.4.11 Irradiation Facility Biological Shield

The staff evaluated the sufficiency of the IF biological shield as described in SHINE PSAR 

Section 4a2.4, using the guidance and acceptance criteria from Section 4a2.4, “Biological 

Shield,” of the ISG Augmenting NUREG-1537, Parts 1 and 2. 

Consistent with the review procedures of Section 4a2.4 of the ISG Augmenting NUREG-1537, 

Part 2, the staff considered whether the shield design bases are sufficient to protect the health 

and safety of the public and employees.

The ISG Augmenting NUREG-1537, Part 2, Section 4a2.4 “Acceptance Criteria,” states, in part, 

that “the principal objective of the shield design should be to ensure that the projected 

radiation dose rates and accumulated doses in occupied areas do not exceed the limits of 

10 CFR Part 20, ‘Standards for Protection Against Radiation,’ and the guidelines of the facility’s 

[as low as is reasonably achievable] ALARA program.” Therefore, in RAI 4a2.5-1 

(Reference 14), in order to determine the adequacy of the shielding design, the staff asked that 

the applicant provide a list of the components inside the IU cell that are considered significant 

contributors to the gamma and neutron flux and dose rates at locations that could be occupied,

as well as to the unrestricted environment. 

In response to RAI 4a2.5-1 (Reference 21), the applicant stated that the components inside the 

IU cell that are considered to be significant contributors to the gamma and neutron fluxes are 

the neutron driver and the SCAS. The applicant also provided the magnitude of the 

contributions from both the neutron driver and the SCAS. 

The staff finds this response satisfies the acceptance criteria of the ISG Augmenting 

NUREG-1537, Section 4a2.4 and demonstrates adequate design criteria for a preliminary 

design. The staff will confirm that the final design conforms to this design basis during the 

evaluation of SHINE’s FSAR. 
Irradiation Units and Radioisotope Production Facility Description

4-17

On the basis of its review, the staff has determined that the level of detail provided on the IF 

biological shield is adequate and supports the preliminary design and satisfied the applicable 

acceptance criteria of NUREG-1537, Part 2, Section 4a2.4, allowing the staff to make the 

following relevant findings: (1) The biological shield is designed to meet the goals described in 

SHINE PSAR Chapter 11, “Radiation Protection Program and Waste Management,” as 

discussed in the staff evaluation in Chapter 11 of the SER, and meets or exceeds the 

requirements in 10 CFR Part 20; (2) the proposed materials and configuration are consistent 

with staff-endorsed guidance (American Nuclear Standards Institute [ANSI]/American Nuclear 

Society [ANS]-6.4.2-2006, “Specification for Radiation Shielding Materials”; American Concrete 

Institute [ACI] 349-06, “Code Requirements for Nuclear Safety-Related Concrete Structures and 

Commentary”; and Regulatory Guide 1.69, Revision 1, “Concrete Radiation Shields and Generic 

Shield Testing for Nuclear Power Plants” (Reference 37). 

Therefore, the staff finds that the information provided on the IF biological shield is sufficient and 

meets the applicable regulatory requirements and guidance for issuance of a construction 

permit in accordance with 10 CFR 50.35.

4a.4.12 Nuclear Design

The staff evaluated the sufficiency of the nuclear design as described in SHINE PSAR Section 

4a2.6, “Nuclear Design,” using the guidance and acceptance criteria from Section 4a2.5, 

“Nuclear Design,” of the ISG Augmenting NUREG-1537, Parts 1 and 2. 

Normal Operating Conditions

Consistent with the review procedures of Section 4a2.5 of the ISG Augmenting NUREG-1537, 

Part 2, the staff considered normal operating conditions of the nuclear design to ensure a 

complete, operable core has been analyzed.

SHINE PSAR Section 4a2.6.1 describes SCAS modes of operations. The SCAS operates 

under three modes that are relevant to nuclear design: Mode 1, startup mode; Mode 2, 

irradiation mode; and Mode 3, post-irradiation mode. A fourth mode is described in SHINE 

PSAR Chapter 7, “Instrument and Control Systems,” and is not discussed in this chapter. In 

each case, the IU can be shut down by the control systems (TRPS and TPCS), which will trip on 

high PCLS temperature or high flux. As an additional administrative control, the operators can 

manually dump the contents of the TSV to the dump tanks, although these measures are not 

required for safe shutdown or operation. When shutdown, the neutron driver is de-energized 

and the target solution is held in criticality-safe dump tanks. There are two completely 

independent dump valves, along with independent dump lines and overflow lines. The dump 

valves fail open and can be triggered by the TRPS, TPCS, and the operator. 

The target solution will be processed through the UNCS after it has been through a specified 

number of irradiation cycles. The burn-up after this amount of exposure is very small, with less 

than 0.02 percent of U-235 undergoing fission per irradiation cycle. The applicant estimates 

that xenon and samarium accumulation will reduce operating neutron multiplication and fission 

power by less than 10 percent relative to a system without xenon-135 and samarium-149. 

A complete analysis of the effects of poison and plutonium buildup will be submitted in the 

FSAR. The staff notes that given the small amount of burnup, the effects of poison and 

plutonium buildup can reasonably be left for consideration during review of the FSAR.
Irradiation Units and Radioisotope Production Facility Description

4-18

The proposed design describes the reactivity and reactivity changes of the system during all 

modes of operation, including reactivity worths of the IU components for each mode of 

operation, the worth of water held up outside the TSV and the effects of removing that water, 

and expected changes in reactivity that would occur due to voiding of the cooling system. The 

system interfaces with the TPCS and TRPS to shut down in abnormal conditions (e.g., loss of 

power, high flux, high hydrogen concentration). The physical and administrative controls that 

are designed to prevent a criticality from occurring are sufficient.

Minor power oscillations during operation are expected, but should be small and self-limiting 

due to the low power density and negative temperature coefficients. In the case of a TOGS 

failure, the resulting void collapse will cause a small reactivity increase, but not large enough to 

result in a criticality. A complete analysis of TSV kinetics will be provided in the FSAR. The 

staff notes that this analysis can reasonably be left for consideration during review of the FSAR.

The ISG Augmenting NUREG-1537, Part 2, Section 4a2.5.1, “Normal Operating Conditions,” 

states that the PSAR should give reactivity worths for control rods, reflector units, and other 

in-core components for all anticipated configurations. While some information is presented on 

coefficients of reactivity in SHINE PSAR Section 4a2.6.2.4, “Coefficients of Reactivity,” the staff 

noted that additional information was needed to verify that the SHINE IUs will not become 

critical under any phase of operation. In RAI 4a2.6-3 (Reference 14), the staff asked that the 

applicant compare the reactivity worths of all components in the IU to the margin to criticality in 

the TSV for all phases of operation.

In response to RAI 4a2.6-3 (Reference 21), the applicant stated, in part, that in Mode 1, startup 

conditions:

[T]he TSV is designed to be filled with uranyl sulfate solution to a level that is 

approximately 5 percent by volume below critical.... While the SHINE TSV is not 

a reactor, there are two moveable components identified within the nuclear 

assembly that have the potential for significant reactivity effects. These two 

components are the tritium chamber and the neutron multiplier. Removing the 

neutron multiplier and flooding the tritium chamber with water from the LWPS 

were calculated to both have negative reactivity effects, thus increasing the 

margin to criticality. 

The staff finds this response satisfies the acceptance criteria of ISG Augmenting NUREG-1537, 

Section 4a2.5.1 and demonstrates adequate design criteria for a preliminary design. The staff 

will confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR. 

As the SHINE system transitions from Mode 1, startup conditions, to Mode 2, irradiation 

conditions, the effective neutron multiplication factor (keff) of the system decreases. Replacing 

the neutron multiplier and flooding the tritium chamber with water from the LWPS were 

calculated to both have negative reactivity effects, thus increasing the margin to criticality. The 

staff will confirm that the final design conforms to this design basis during the evaluation of the 

SHINE FSAR.

The SHINE SCAS cooling includes a PCLS and an LWPS cooling loop. The staff notes that a 

pipe break in one of the cooling systems or other means of introducing voids, lowering the 

coolant density in the system, could result in a reactivity insertion. To determine if voiding out 

the cooling system could turn the TSV from a subcritical system into a critical reactor, in 
Irradiation Units and Radioisotope Production Facility Description

4-19

RAI 4a2.6-4 (Reference 14), the staff asked that the applicant provide reactivity worth for 

voiding out the cooling system over the full range from nominal coolant temperature and density 

to a fully voided cooling system.

In response to RAI 4a.2.6-4 (Reference 21), the applicant provided reactivity changes due to 

LWPS and PCLS voids. The data provided shows that for the PCLS, there is a negative 

insertion of reactivity as the percent void increases. In the LWPS, a significant amount of void 

(greater than 20 percent) must be present to add a substantial amount of reactivity at startup 

conditions. The applicant stated, in part, that:

The design will prevent the introduction of a significant amount of void into the 

SCAS, such as the use of a delay tank to vent entrained voids located 

downstream of the LWPS cooling pump. Positive pressures are expected in the 

piping line downstream of the LWPS cooling pump, which will prevent the 

introduction of void since a break in the line would result in the loss of water 

rather than the ingress of air. Flow meters and pressure detection on the LWPS 

are planned, which would also indicate if a significant amount of air entered the 

pump, since the output pressure and flow will decrease. 

The staff finds this response satisfies the acceptance criteria of ISG Augmenting NUREG-1537, 

Section 4a2.5.1 and demonstrates adequate design criteria for a preliminary design. The staff 

will confirm that the final design conforms to this design basis during the evaluation of the 

SHINE FSAR. 

Section 4a2.5.1 of the ISG Augmenting NUREG-1537, Part 2, states that there should be 

systems that are “sufficiently redundant and diverse to control all proposed excess reactivity 

safely and to safely shut down the reactor and maintain it in a shutdown condition.” The SHINE 

IU system relies on dumping the solution to the TSV dump tank under abnormal conditions. 

SHINE PSAR Section 4a2.6.3.6, “Redundancy and Diversity of Shutdown Methods,” states that 

the dump system has redundant dump valves. In RAI 4a2.6-8 (Reference 14), the staff asked 

that the applicant provide additional information on the design drain rate of the TSV when the 

dump valves are open, the delay time from the drain valve open signal until the valves start to 

open, and the duration of time it takes the dump valves to open. 

In response to RAI 4a2.6-8 (Reference 21), the applicant noted that the TSV drain system is 

designed to drain a minimum of 20 gallons per minute (gpm) when the dump valves are open 

(design drain rate is conservatively based on only one drain line available), the delay time 

between the conditions that would trigger a dump signal and the start of the dump valves 

opening will be a maximum of one second, and the duration of time it takes for the dump valves 

to open will be less than 5 seconds.

The staff finds this response satisfies the acceptance criteria of Section 4a2.5.1 of the ISG 

Augmenting NUREG-1537, and demonstrates adequate design criteria for a preliminary design. 

The staff will confirm that the final design conforms to this design basis during the evaluation of 

SHINE’s FSAR. 

Section 4a2.5.1 of the ISG Augmenting NUREG-1537, Part 2, “Acceptance Criteria,” states, in 

part, “the reactivity impacts of radiolytic gas and void formation, fission product gas removal, 

fuel solution and acid addition, and condensate return to the core should be provided.” This 

analysis should also include the evaporation of water. SHINE PSAR Section 4a2.6.1.1, “Gas 

Management System Effects,” states, in part, that “the radiolysis of water in the system causes 
Irradiation Units and Radioisotope Production Facility Description

4-20

an anticipated increase in reactivity during operation....” The SHINE PSAR infers that water is 

constantly leaving the TSV through radiolysis and evaporation. A certain amount of water will 

be held up outside the TSV as it goes through the recombination and condensation process 

before it is returned to the TSV, increasing the reactivity in the system.

In RAI 4a2.6-9 (Reference 14), the staff asked the applicant to provide quantitative estimates of 

the water inventory outside of the TSV, the reactivity increase caused by removing that water 

from the TSV, and the increase in fuel solution concentration.

In response to RAI 4a2.6-9 (Reference 21), the applicant stated that a small percentage of the 

water volume of the TSV may be held up outside of the TSV in the TOGS. The reactivity 

increase caused by removing that water from the TSV during irradiation mode was estimated to 

be small in comparison to the expected subcritical reactivity of the SHINE system during 

irradiation mode. 

The staff finds this response satisfies the acceptance criteria of ISG Augmenting NUREG-1537, 

Section 4a2.5.1 and demonstrates adequate design criteria for a preliminary design. The staff 

will confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

On the basis of its review, the staff has determined that the level of detail provided on normal 

operating characteristics is adequate and supports the preliminary design and satisfied the 

applicable acceptance criteria of NUREG-1537, Part 2, Section 4a2.5.1.

Therefore, the staff finds that the information provided on the normal operating conditions is 

sufficient and meets the applicable regulatory requirements and guidance for issuance of a 

construction permit in accordance with 10 CFR 50.35 and 50.40.

Target Solution Physics Parameters

Consistent with the review procedures of Section 4a2.5 of the ISG Augmenting NUREG-1537, 

Part 2, the staff considered target solution physics parameters of the nuclear design to ensure: 

(1) generally accepted and validated methods have been used for calculations, and 

(2) derivation and adequacy of uncertainties and errors have been considered.

SHINE PSAR Section 4a2.6.2, “Target Solution Physics Parameters,” describes how a variety 

of codes will be used to calculate various nuclear physics parameters. Monte-Carlo N-Particle 

Transport Code-5 (MCNP5) will be used to calculate neutron flux, reactivity, dose rates, neutron 

lifetime, and reaction rates. COUPLE, part of the NRC’s SCALE code, will be used to calculate 

flux-dependent cross-sections and fission yields. ORIGEN will be used to generate source term 

concentrations and activities following various irradiation and decay intervals. The staff has also 

reviewed SHINE’s uncertainty analysis for the calculations using these codes, which was 

submitted in responses to the staff’s RAIs. These calculations will be compared to benchmark 

experiments for validation. 

The ISG Augmenting NUREG-1537, Part 2, Section 4a2.5.2, “Reactor Core Physics 

Parameters,” states, in part, that “the applicant should present information on core physics 

parameters that determine reactor operating characteristics....” The SHINE PSAR did not 

discuss the effects of xenon-135 and samarium-149 on the TSV operation irradiation cycle. 

Therefore, in RAI 4a2.6-5 (Reference 14), the staff asked the applicant to provide an estimate of 

the reactivity due to xenon-135 and samarium-149 over the cycle and its effect on neutron 
Irradiation Units and Radioisotope Production Facility Description

4-21

multiplication and fission power, since the time required to establish equilibrium xenon and 

samarium is significant compared to the length of an irradiation cycle. 

In response to RAI 4a2.6-5 (Reference 21), the applicant stated that the reactivity worth of 

fission product poisons such as xenon and samarium is small compared to the temperature and 

void defects. The staff notes that the applicant committed to provide a complete analysis of the 

effects of poisons in the FSAR. The staff notes that this analysis can reasonably be left for 

consideration during review of the FSAR.

The staff finds this response satisfies the acceptance criteria of ISG Augmenting NUREG-1537, 

Section 4a2.5.2 and demonstrates adequate design criteria for a preliminary design. The staff 

will confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

The ISG Augmenting NUREG-1537, Part 2, Section 4a2.5.2, “Reactor Core Physics 

Parameters,” states, in part, that “the applicant should present information on core physics 

parameters that determine reactor operating characteristics....” 

Therefore, in RAI 4a2.6-6 (Reference 14), the staff asked that the applicant provide an 

uncertainty analysis for the reactivity worths, coefficients, and keff values.

In response to RAI 4a2.6-6 (Reference 21), the applicant stated, in part, that “reactivity worths 

coefficients, and keff values are calculated using MCNP5, version 1.60 ... SHINE does not plan 

to use the absolute keff predictions from MCNP as the basis to determine operating keff of the 

SCAS. Instead, SHINE plans to use a volume margin-to-critical approach coupled with the 

calculated reactivity worth of that volume....” SHINE will also ensure that the detector, source, 

and SCAS geometry result in conservative 1/M plots to ensure that early predictions of critical 

volume are lower than actual critical volume and result in lower actual keff values. A plan to 

validate the neutronics predictions will be included with the FSAR. 

The staff finds this response satisfies the acceptance criteria of ISG Augmenting NUREG-1537, 

Section 4a2.5.2 and demonstrates adequate design criteria for a preliminary design. The staff 

will confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

Preliminary calculations show that target solution void, temperature, and power coefficients will 

generally be negative for all modes of operation. The temperature coefficients for the PCLS and 

LWPS may not be negative during some conditions, but the combined effects of reactivity 

coefficients are expected to result in strong negative feedback. The target solution temperature 

coefficient should be the most significant because the majority of the heat is deposited directly 

in the target solution. The applicant’s analyses show that the combined reactivity coefficients 

should be sufficiently negative over the anticipated range of operating conditions.

On the basis of its review, the staff has determined that the level of detail provided on target 

solution physics parameters is adequate and supports the preliminary design and satisfied the 

applicable acceptance criteria of NUREG-1537, Part 2, Section 4a2.5.2.

Therefore, the staff finds that the information provided on the normal operating conditions is 

sufficient and meets the applicable regulatory requirements and guidance for issuance of a 

construction permit in accordance with 10 CFR 50.35.
Irradiation Units and Radioisotope Production Facility Description

4-22

Operating Limits

Consistent with the review procedures of Section 4a2.5 of the ISG Augmenting NUREG-1537, 

Part 2, the staff considered operating limits of the nuclear design to ensure methods and 

assumptions used in determining operating limits are consistent.

Specific values for operating limits will be provided in the FSAR after the final design is 

complete. However, the SHINE PSAR discusses some requirements. SHINE PSAR Section 

4a2.6.2, “Target Solution Physics Parameters,” describes the need for void coefficients to be 

negative throughout all operating conditions and combined reactivity coefficients should be 

sufficiently negative over the anticipated range of operating conditions. Additionally, the target 

solution burn-up should be minimal in the SCAS. 

SHINE PSAR Section 13a2.1.2, “Insertion of Excess Reactivity/Inadvertent Criticality,” 

discusses the three initiating events that may result in inadvertent insertions of excess reactivity: 

excessive cooldown of the TSV, increased pressure in the TSV, and excess volume of target 

solution. None of these events should result in damage to the PSB. In the event of a loss of 

power, the neutron driver will de-energize and the target solution will be transferred to 

criticality-safe dump tanks.

As previously stated above under “Normal Operating Conditions,” a complete analysis of the 

TSV kinetics and effects of poison and plutonium buildup will be submitted in the FSAR. The 

staff concluded that this analysis can reasonably be left for consideration during review of the 

FSAR. A detailed evaluation of technical specifications, including limiting conditions of 

operations (LCOs) and surveillance requirements, will also be performed during the review of 

the FSAR.

On the basis of its review, the staff has determined that the level of detail provided on operating 

limits is adequate and supports the preliminary design and satisfied the applicable acceptance 

criteria of NUREG-1537, Part 2, Section 4a2.5.3.

Therefore, the staff finds that the information provided on the normal operating limits is sufficient 

and meets the applicable regulatory requirements and guidance for issuance of a construction 

permit in accordance with 10 CFR 50.35.

Nuclear Design Findings

On the basis of its review, the staff has determined the SHINE PSAR gives an adequate 

description of the proposed configuration of the SCAS during the three relevant modes of 

operation. Target solution behavior during operation has been adequately addressed, including 

gaseous fission product buildup and removal, poisons, and power oscillations. Reactivity 

analyses include reactivity values for the in-core components. Analyses of neutron lifetime, 

effective delayed neutron fraction, and coefficients of reactivity are in progress or have been 

completed using methods validated at similar facilities and through experimental 

measurements. Final values for all nuclear physics parameters will be presented in the FSAR.

The staff finds that the applicant’s descriptions of the nuclear design component of the facility 

are adequate and are consistent with 10 CFR 50.34, 50.35, and 50.40. Therefore, the staff 

finds that the applicant’s description of the nuclear design is sufficient for the issuance of a 

construction permit.
Irradiation Units and Radioisotope Production Facility Description

4-23

4a.4.13 Thermal-Hydraulic Design

The staff evaluated the sufficiency of the thermal hydraulic design as described in SHINE PSAR 

Section 4a2.7, “Thermal Hydraulic Design,” using the guidance and acceptance criteria from 

Section 4a2.6, “Thermal-Hydraulic Design,” of the ISG Augmenting NUREG-1537, Parts 1 

and 2. 

Consistent with the review procedures of Section 4a2.6 of the ISG Augmenting NUREG-1537, 

Part 2, the staff reviewed the thermal-hydraulic analyses for completeness and considered 

whether the analyses addressed all issues that affect key parameters (e.g., flow, temperature, 

pressure, power density, pH, and peaking). The staff considered whether the analyses 

submitted show that sufficient cooling capacity exists to prevent target solution overheating and 

loss of target solution barrier for anticipated system operating conditions.

The ISG Augmenting NUREG-1537, Part 2, Section 4a2.6 states, in part, that the applicant 

should discuss possible system “instability following perturbation to the system (including from 

radiolytic gas generation).” Therefore, in RAI 4a2.7-1 (Reference 14), the staff asked that the 

applicant provide a linear stability analysis of the full system and an analysis and discussion of 

the expected bounds of any expected oscillations.

In response to RAI 4a2.7-1 (Reference 21), the applicant provided a linear stability analysis and 

stated, in part, that:

Subcritical accelerator-driven fissile solution systems were found to be 

unconditionally stable in the linear approximation. Perturbations from the TOGS 

can result in pressure changes in the TSV. However, these pressure changes 

only serve to impose a reactivity feedback term and do not alter the [conclusions 

in the analysis]. 

Oscillations in TSV fission power are expected to be the result of coupled system 

oscillations, principally due to potential pressure variations in the TOGS and 

source oscillations from the neutron driver. Pressure variations in the TOGS at 

the TSV are expected to be less than 0.5 psi, and this pressure change has been 

estimated to minimally affect TSV reactivity during irradiation. . . This change in 

reactivity is estimated to result in [a minimal] change in TSV power.

Oscillations in the neutron driver neutron output are expected to be less than 3 

percent from the target neutron output. With a SCAS and no feedback effects, a 

change of 3 percent in the neutron source term would result in a 3-percent 

change in the output of the assembly. Due to negative temperature and void 

reactivity coefficients, the oscillations from this source variation will be less than 3 

percent.

Total oscillations in TSV fission power are expected to be [small] due to potential 

superposition of these sources of oscillation. As described in PSAR Section 

4a2.6.1.2, “TSV Operating Characteristics,” results of transient modeling of 

power oscillations using a dynamic model and reactivity feedback effects will be 

provided with the FSAR.

The staff finds this response satisfies the acceptance criteria of ISG Augmenting NUREG-1537, 

Section 4a2.6 and demonstrates adequate design criteria for a preliminary design. The staff will 
Irradiation Units and Radioisotope Production Facility Description

4-24

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

Heat Removal Systems

SHINE PSAR Section 4a2.7.1.1, “Thermal-Hydraulic Design,” discusses the systems used to 

remove heat during irradiation and shutdown operations. The paths for heat removal from the 

TSV are the PCLS, the LWPS, and the TOGS.

SHINE PSAR Section 4a2.7.1.1.1, “PCLS Cooling Loop,” describes the PCLS cooling loop, 

which circulates water in an upward direction past the TSV heat transfer surfaces using forced 

convective cooling. Energy can also be deposited into the PCLS coolant by neutron and 

gamma radiation. The PCLS cooling water removes heat from the TSV, then flows to reject the 

heat through a heat exchanger in the radioisotope process facility cooling system (RPCS).

SHINE PSAR Section 4a2.7.1.1.2, “LWPS Cooling Loop,” describes the LWPS cooling loop, 

which removes heat from the neutron multiplier and from the neutron driver tritium target 

chamber using forced convective flow. Energy can also be deposited into the LWPS coolant by 

neutron and gamma radiation. The LWPS also removes heat from the light water pool. The

heat loads on the light water pool are energy deposition by neutron and gamma radiation from 

an operating IU and decay heat loads from the dump tank when it contains the irradiated target 

solution. The LWPS cooling water rejects heat to the RPCS. The TOGS operates as a closed 

loop system in which sweep gas is circulated above the top of the TSV liquid level. The gas is 

circulated through a flow loop that removes iodine from the off-gas, recombines 

radiolysis-generated hydrogen and oxygen to keep them below flammable limits, and 

condenses water vapor and returns the liquid water to the TSV. Heat from the condensation 

and recombination processes are transferred through heat exchangers that ultimately reject 

heat to the RPCS. 

The cooling system design basis and details of the PCLS, LWPS, and RPCS are provided in 

SHINE PSAR Chapter 5, “Cooling Systems.” The staff’s evaluation of these systems is in 

Chapter 5, “Cooling Systems,” of this SER.

Coolant Hydraulic Characteristics of the Target Solution

SHINE PSAR Section 4a2.7.2, “Coolant Hydraulic Characteristics of the Target Solution 

Vessel,” provides details on the PCLS. The PCLS volumetric coolant flow rate is 4.7 liters per 

second. The coolant water enters at 20 degrees Celsius (°C) and exits at 26.7 °C. The TSV 

pressure is maintained below the PCLS pressure to prevent leakage out of the TSV in cases 

where the PSB is breached. In the case of leakage of water from the PCLS into the TSV, the 

dilution of the target solution will lead to a negative reactivity insertion. If the breach is large 

enough so that the pressure difference cannot be maintained, then some of the radioactive 

target solution could leak into the PCLS cooling water. The nominal temperature of the solution 

in the TSV is 60 °C. The operating conditions in the TSV should prevent plate out of chemicals 

on the PCLS heat transfer surfaces. A loss or degradation of the PCLS cooling system would 

cause an increase in the target solution temperature. If the target solution temperature rises 

above the allowable limit, the TRPS system will shut down the neutron driver and dump the 

target solution to the TSV dump tank where it will be cooled by natural convection in the light 

water pool. The light water pool is cooled by the LWPS. In cases that the LWPS is not 

operating, the light water pool has a large heat capacity that can be used to remove decay heat 

from the TSV dump tank for long periods of time without active cooling. The heat capacity of 
Irradiation Units and Radioisotope Production Facility Description

4-25

the pool is large enough that the pool temperature will increase by only 11.8 °F from 90 days of 

decay heat load.

The cooling system design basis and details of the PCLS and LWPS are provided in SHINE 

PSAR Chapter 5. The staff’s evaluation of these systems is in Chapter 5 of this SER.

Target Solution Thermal Power Density Distribution

SHINE PSAR Section 4a2.7.3, “Target Solution Thermal Power Density Distribution,” states “[a] 

detailed analysis of the thermal and nuclear parameters of the target solution (power density, 

heat flux, neutron flux, and detailed temperature gradient profile) will be determined during final 

design. For physical properties of the target solution (e.g., pH, uranium density) in the TSV, see 

PSAR Table 4a2.2.1-1.”

The staff notes the fission power density should have peaks in the axial and radial dimensions 

due to neutron transport effects. The radiolysis gas generation source is related to the fission 

power source since the primary mechanism for producing radiolysis gas is slowing down of the 

fission fragments. Neutron and gamma radiation can also be a source of radiolysis gas 

formation. The decay power distribution is not directly related to the fission power distribution 

since the fission products that are the source of decay power will circulate with the target 

solution. The thermal power density distribution should drive gradients in fluid temperature and 

void fraction that enhance natural circulation in the target solution.

The staff has considered the statements in the PSAR and determined, using the guidance in the

ISG Augmenting NUREG-1537, that this information is specifically related to the final design of 

the SHINE facility, and as such, is not necessary for the issuance of a construction permit.

Thermal-Hydraulic Methodology

SHINE PSAR Section 4a2.7.4, “Thermal-Hydraulic Methodology,” discusses the applicant’s use 

of a correlation-based thermal-hydraulic methodology for safety calculations in the FSAR for 

calculations involving fluid flow and convective heat transfer. The heat transfer in structures will 

be used to solve conduction heat transfer equations. The nuclear heat generation rates will be 

calculated using MCNP5. Detailed thermal-hydraulic design optimization calculations will use 

Computational Fluid Dynamics (CFD) software, including Fluent and CFX, which includes 

volumetric heat and gas generation sources. The calculations are used to estimate the steady 

state target solution temperature, which is determined by the balance of the heat generation and 

the heat removal to the heat transfer surfaces by natural circulation flows caused by 

temperature and void fraction gradients. The results of experiments performed at the University 

of Wisconsin – Madison, using electric heaters and bubble injection to simulate the effects of 

volumetric heating and gas generation, will be used to determine the expected range of heat 

transfer coefficients and void fractions. They were also used to validate CFD calculations. 

Details of the methodologies including validation of the methods and calculation results will be 

provided in the SHINE FSAR.

Impact of Operating Conditions on Thermal-Hydraulics

SHINE PSAR Section 4a2.7.5, “Impact of Operating Conditions on Thermal-Hydraulics,” states 

the heat removal and recombination capacities of the TOGS will determine the pressure of the 

gas space and target solution for a fixed TSV power. During steady-state operation, feedback 

effects on the power generation will determine the operating power and pressure where there is 
Irradiation Units and Radioisotope Production Facility Description

4-26

a balance between the gas and water vapor generation in the TSV and the heat removal and 

recombination capacity of the TOGS. It is also possible that the system may operate in 

oscillatory mode with operating conditions that vary but stay within safety limits. SHINE 

provided a stability analysis of the accelerator-driven system that was performed by Los Alamos 

National Laboratory (LANL) and documented in the report LA-UR-14-28684, “Stability of Fissile 

Solution Systems.” The LANL stability analysis showed that the system is stable across the 

expected range of operation and any oscillations should be damped. Driven bounded reactivity 

or source strength oscillations will also result in a bounded response. The target solution is 

expected to be stable with respect to chemical and physical properties during an irradiation 

cycle. Void formation in the target solution will be caused by radiolysis gas formation. The 

effects of the voids on nuclear and heat transfer performance of the system will be accounted 

for in the final design. The void formation should enhance the heat transfer in the TSV due to 

increased natural circulation flows due to buoyancy effects. The natural circulation should also 

help prevent large non-uniformities in temperature and solution concentration. Target solution 

pressure, temperature, pH, and solution concentration, will be monitored and maintained 

throughout the cycle. The hydrogen concentration in the cover gas will also be monitored and 

maintained through the cycle.

Cooling System Design Bases

SHINE PSAR Section 4a2.7.6, “Cooling System Design Bases,” discusses the thermal-hydraulic 

design systems described above that provide heat removal from the TSV. The cooling system 

design basis and details of the PCLS and LWPS are provided in SHINE PSAR Chapter 5. The 

staff’s evaluation of these systems is in Chapter 5 of this SER.

Cooling Performance

SHINE PSAR Section 4a2.7.7, “Cooling Performance,” discusses generation of small amounts 

of radiolysis gases in the PCLS coolant since it is exposed to radiation from the TSV. The 

system is designed so that large pockets of gas will not accumulate and lead to significant void 

fractions in the region of the TSV.

Bulk Boiling of the Target Solution

SHINE PSAR Section 4a2.7.8, “Bulk Boiling of the Target Solution,” discusses monitoring of the 

target solution temperature. The temperature and flow of the PCLS loop is also monitored to 

ensure adequate cooling of the TSV. The TRPS system will shut down the neutron driver and 

dump the target solution to the TSV dump tank. This should prevent boiling in the TSV. If 

boiling were to occur due to unforeseen circumstances, the target solution and off gases will still 

be confined within the PSB and will not present a radiation hazard.
Irradiation Units and Radioisotope Production Facility Description

4-27

Thermal-Hydraulic Design Findings

The staff has reviewed the thermal-hydraulic design of the IU. The thermal-hydraulic design 

considers the dominant design for heat removal, cover gas control, and target solution control. 

On the basis of its review, the staff has determined that the SHINE facility has considered all 

significant heat loads and has provided adequate heat removal capacity and heat transfer area 

to remove the heat loads and maintain the TSV fluid conditions under normal and abnormal 

conditions. The heat transfer coefficients that would be required to maintain the assumed 

design conditions should be achievable. Adequate heat removal through natural circulation and 

convection within the pool is also provided for decay heat generation in the TSV dump tank. 

The fluid and structures temperatures and heat fluxes eliminate concerns about critical heat flux 

in all cases. The TOGS has the recombination and condensation capacity to control the cover 

gas operating conditions and maintain them within normal operating parameters. The potential 

technical specifications that have been proposed are adequate to maintain operating conditions 

within acceptable limits. 

The staff finds that the applicant’s descriptions of the thermal-hydraulic design for the facility are 

adequate and are consistent with 10 CFR 50.34 and 10 CFR 50.35. Therefore, the staff finds 

that the applicant’s descriptions of the thermal-hydraulic design are sufficient for the issuance of 

a construction permit.

4a.4.14 Gas Management System

The staff evaluated the sufficiency of the preliminary design of the SHINE gas management 

system, as described in SHINE PSAR Section 4a2.8, “Gas Management System,” by using the 

guidance and acceptance criteria from Section 4a2.7, “Gas Management System,” of the ISG 

Augmenting NUREG-1537, Parts 1 and 2.

Consistent with the review procedures of Section 4a2.7 of the ISG Augmenting NUREG-1537, 

Part 2, the staff evaluated the design of the gas management system and associated analysis 

for safe operation and compliance with all applicable chemical and radiological release criteria.

SHINE PSAR Section 4a2.8 describes the TOGS, which removes gaseous fission products and 

radiolytic gasses from the TSV during operation of the irradiation unit. The hydrogen 

recombiners prevent the hydrogen concentration from reaching a level where a deflagration or 

detonation could occur. This also serves to conserve water in the system. The TOGS also 

condenses water vapor and returns the water to the TSV. The construction materials used for 

the TOGS must be compatible with the expected chemical environment, and no credible 

scenarios should result in a loss of confinement as a consequence of corrosion. The geometry 

of the TOGS should preclude criticality even if filled with the target solution.

Consistent with the review procedures of the ISG Augmenting NUREG-1537, Part 2, 

Section 4a2.7, the staff should confirm that the design of the gas management system and the 

associated analysis are sufficient to provide reasonable assurance of safe operation of the 

reactor and compliance with all applicable chemical and radiological release criteria. 

Therefore, in RAI 4a2.8-1 (Reference 14), the staff asked that the applicant provide the TSV 

operating condition envelope and design assumptions for the TSV off-gas recombiner system, 

including assumed design margins.
Irradiation Units and Radioisotope Production Facility Description

4-28

In response to RAI 4a2.8-1 (Reference 21), the applicant provided the TSV operating envelope, 

the TOGS design assumptions for the gas leaving the TSV headspace during normal operation, 

and the assumed design margins of the TOGS components.

The staff finds this response satisfies the acceptance criteria of ISG Augmenting NUREG-1537, 

Section 4a2.7 and demonstrates adequate design criteria for a preliminary design. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

In RAI 4a2.8-2 (Reference 14), the staff asked that the applicant provide the basis for an “alert 

to the operator” at a hydrogen concentration of 2.5 percent and automatic shutdown of the 

neutron driver at 3 percent and to discuss whether there is sufficient margin to the deflagration 

limits at these values. The staff also asked the applicant to provide information indicating where 

the measurement of the hydrogen concentration is taken.

In response to RAI 4a2.8-2 (Reference 21), the applicant stated, in part, that:

. . . normal operation of the TOGS maintains hydrogen concentrations at or 

below 2 percent in the off-gas. The alarm setpoint of 2.5 percent is slightly 

higher than normal operating conditions to provide advanced warning of 

abnormal conditions to the operator prior to reaching the trip setpoint, while not 

resulting in excessive alarms that distract the operators in the control room. The 

hydrogen concentration trip point of 3 percent provides approximately 33 percent 

margin to the lower flammability limit of 4 percent. The hydrogen concentration 

trip point ensures that the initial hydrogen concentration in the TOGS is 

sufficiently low in the event of an abnormal condition, such as a blower 

malfunction.

The margin to the deflagration limit is sufficient because it is not expected that 

the hydrogen concentration would reach 4 percent in the event of a failure of a 

single active component (i.e., a blower) if the initial concentration is below 

3 percent. After a blower failure is detected, such as through reduced flow, the 

TRPS would trip the TSV and neutron driver. A peak hydrogen concentration of 

3.9 percent is estimated to occur in the case of a failure of a single active 

component (blower).

The staff notes that the hydrogen recombiner should be capable of preventing a hydrogen 

deflagration or detonation. The system will alert the operator of high hydrogen concentration if it 

reaches 2.5 percent by volume. Should the recombiner fail to prevent the rise of hydrogen 

concentration, the neutron driver will be shut down when the concentration reaches 3 percent. 

The applicant’s analysis shows that this will provide sufficient margin to the lower flammability 

limit in the event of an abnormal condition such as a blower failure. The staff further notes that 

as long as sensors accurately capture the highest hydrogen concentration, both the alarm and 

the trip set-points would correspond to hydrogen concentrations below the upward propagation 

flammability limit in steam-saturated air of 4.1 percent listed in NUREG/CR-2726: “Light Water 

Reactor Hydrogen Manual.” The system design pressure has not yet been specified but the 

applicant has stated the system will be designed to withstand system pressures expected during 

credible TSV power fluctuations and hydrogen deflagrations. The applicant committed to 

perform calculations during detailed design that will ensure there is sufficient margin to 

deflagration limits.
Irradiation Units and Radioisotope Production Facility Description

4-29

The staff finds this response satisfies the acceptance criteria of ISG Augmenting NUREG-1537, 

Section 4a2.7 and demonstrates adequate design criteria for a preliminary design. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

SHINE PSAR Table 4a2.8-1, “TSV Off-Gas System Major Components,” states that the 

condenser in the TSV off-gas condenser has a greater than 15 percent heat transfer margin. 

Since vapor pressure of water changes rapidly with temperature in the vicinity of 140 °F, for 

example, increasing the water temperature from 140 °F to 150 °F increases the vapor pressure 

by approximately 33 percent, the staff was concerned that non-condensable gas can 

significantly degrade the condensation efficiency in comparison to the condensation of pure 

steam.

Therefore, in RAI 4a2.8-4 (Reference 14), the staff asked that the applicant provide the TSV 

and off-gas system operating conditions and assumptions used to calculate the 15-percent 

margin. 

In response to RAI 4a2.8-4 (Reference 21), the applicant provided the TSV operating envelope 

and TOGS design assumptions for the gas leaving the TSV headspace during normal operation. 

The applicant stated, in part, that:

[An] analysis of the TSV off-gas condenser heat transfer capabilities will be 

performed during the final design of the system. The condenser analysis will 

document the inputs and assumptions to the design of the TSV off-gas 

condenser, including consideration for bounding operating pressures and 

temperatures, corresponding steam vapor pressure, expected non-condensable 

gas concentrations, the impact on condenser performance, and operational 

degradation during the life of the condenser. The required TSV off-gas 

condenser specifications will be determined based on the bounding inputs and 

conservative assumptions. Then, an additional 15-percent design margin will be 

applied to the heat transfer area.

The staff finds this response satisfies the acceptance criteria of ISG Augmenting NUREG-1537, 

Section 4a2.7 and demonstrates adequate design criteria for a preliminary design. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

SHINE PSAR Section 4a2.8.5, “Abnormal Conditions,” states that a pressure safety valve is 

connected to the TOGS piping to passively prevent an over pressurization within the PSB, 

which may cause structural damage to the IU. Since the TOGS system contains radioactive 

fission products, in RAI 4a2.8-5, the staff asked that the applicant provide information indicating 

whether the relief valve discharge passes through a system capable of filtering or scrubbing out 

radioactive fission products and provide a description of such a system if it exists. 

In response to RAI 4a2.8-5 (Reference 21), the applicant stated, in part, that:

[it] plans on connecting the pressure safety valve connected to the TOGS piping 

to the noble gas removal system (NGRS). The final design of the NGRS will 

ensure the system contains a relief volume capable of receiving gas from TOGS 

in the event of an over-pressurization. Relief gases in the NGRS will be sampled 

and held for decay. Upon completion of an appropriate decay period, the gases 
Irradiation Units and Radioisotope Production Facility Description

4-30

in the NGRS will again be analyzed for radioactivity, and released to the process 

vessel vent system (PVVS). In the PVVS, the off-gas is mixed with other process 

vessel exhaust gases, scrubbed through an acid-gas scrubber (caustic scrub 

solution), and vented to Radiological Controlled Area Ventilation System Zone 1 

(RVZ1), and exhausted out the facility stack following high-efficiency particulate 

air (HEPA) and charcoal filtration. This process will ensure that the radioactive 

release and dose requirements of 10 CFR Part 20 are met.

The staff finds this response satisfies the acceptance criteria of ISG Augmenting NUREG-1537, 

Section 4a2.7 and demonstrates adequate design criteria for a preliminary design. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

On the basis of its review, the staff has determined that the level of detail provided on the gas 

management system is adequate and supports the preliminary design. The staff finds that the 

preliminary design of the SHINE gas management system, as described in SHINE PSAR 

Section 4a2.8, is sufficient and meets the guidance and satisfies regulatory requirements for the 

issuance of a construction permit in accordance with 10 CFR 50.35. Further technical or design 

information required to complete the safety analysis may reasonably be left for later 

consideration. The staff will confirm that the final design conforms to this design basis during 

the evaluation of SHINE’s FSAR.

Therefore, the staff finds that the information provided on the gas management system is 

sufficient and meets the applicable regulatory requirements and guidance for issuance of a 

construction permit in accordance with 10 CFR 50.35

4a.4.15 Probable Subjects of Technical Specifications

In accordance with 10 CFR 50.34(a)(5), the staff evaluated the sufficiency of the applicant’s 

identification and justification for the selection of those variables, conditions, or other items 

which are determined to be probable subjects of technical specifications for the SHINE IU, with 

special attention given to those items which may significantly influence the final design.

Based on the information provided in PSAR Table 14a2-1, “SHINE Facility Proposed 

Parameters for Technical Specifications,” the staff finds that identification and justification of the 

proposed limiting conditions of operations for the gas management system is sufficient and 

meets the applicable regulatory requirements for the issuance of a construction permit in 

accordance with 10 CFR 50.35. A detailed evaluation of technical specifications, including 

limiting conditions of operations and surveillance requirements, will be performed during the 

review of the SHINE FSAR.

4a.5 Summary and Conclusions

As described in SHINE PSAR Section 4a2.1, the IU is an accelerator-driven subcritical 

operating assembly used for the irradiation of an aqueous uranyl sulfate target solution, 

resulting in the production of Mo-99 and other fission products. The summary and conclusions 

provided below apply to the eight IUs that are part of SHINE’s IF.

The staff evaluated the descriptions and discussions of SHINE’s IUs, as described in SHINE 

PSAR Section 4a2 and supplemented by the applicant’s responses to RAIs, and finds that the 

preliminary design of SHINE’s IU, including the principal design criteria, design bases, and 
Irradiation Units and Radioisotope Production Facility Description

4-31

information relative to materials of construction, general arrangements, provides reasonable 

assurance that the final design will conform to the design basis and meets all applicable 

regulatory requirements and acceptance criteria in or referenced in ISG Augmenting 

NUREG-1537. The IUs are designed to operate with a minimum heat load during normal 

operation, which would promptly lessen by at least an order of magnitude following IU 

shutdown. This, coupled with the absence of long-lived fission product build-up following 

shutdown, indicates that operation of this facility would pose a minimal risk to the health and 

safety of the public.

The staff finds that the applicant’s description of the SCAS and its components, including 

operating limits and operating conditions, is consistent with 10 CFR 50.34 and 10 CFR 50.35. 

On the basis of its review, the staff has determined that the level of detail provided on the SCAS 

demonstrates an adequate design basis for preliminary design and satisfies the applicable 

acceptance criteria of the ISG Augmenting NUREG-1537, Part 2. Therefore, the staff concludes 

that the applicant’s descriptions of the equipment, facilities, and procedures are adequate for 

the granting of a construction permit.

On the basis of these findings, the staff has made the following conclusions for the issuance of

a construction permit in accordance with 10 CFR 50.35 and 50.40:

(1) SHINE has described the proposed design of the IU, including, but not limited to, the 

principal architectural and engineering criteria for the design, and has identified the 

major features or components incorporated therein for the protection of the health and 

safety of the public.

(2) Further technical or design information required to complete the safety analysis of the 

IU may be reasonably left for later consideration in the FSAR.

(3) There is reasonable assurance that, taking into consideration the site criteria contained 

in 10 CFR Part 100, the proposed facility can be constructed and operated at the 

proposed location without undue risk to the health and safety of the public.

(4) There is reasonable assurance: (i) that the construction of the SHINE facility will not 

endanger the health and safety of the public, and (ii) that construction activities can be 

conducted in compliance with the Commission’s regulations.

(5) The issuance of a permit for the construction of the facility would not be inimical to the 

common defense and security or to the health and safety of the public.

4b Radioisotope Production Facility

SER Section 4b, “Radioisotope Production Facility,” provides an evaluation of the preliminary 

design of SHINE’s RPF as presented in SHINE PSAR Section 4b, “Radioisotope Production 

Facility Description.”

4b.1 Areas of Review

The staff reviewed SHINE PSAR Section 4b against applicable regulatory requirements using 

regulatory guidance and standards to assess the sufficiency of the preliminary design and 

performance of the SHINE RPF systems. As part of this review, the staff evaluated descriptions 

and discussions of the SHINE RPF, with special attention to design and operating 
Irradiation Units and Radioisotope Production Facility Description

4-32

characteristics, unusual or novel design features, and principal safety considerations. The 

preliminary design of the SHINE RPF was evaluated to ensure the sufficiency of principal 

design criteria; design bases; and information relative to materials of construction, general 

arrangement, and approximate dimensions, sufficient to provide reasonable assurance that the 

final design will conform to the design basis. In addition, the staff reviewed SHINE’s 

identification and justification for the selection of those variables, conditions, or other items, 

which are determined to be probable subjects of technical specifications for the facility, with 

special attention given to those items which may significantly influence the final design.

Areas of review for this section included the facility and process description, the RPF biological 

shield, the radioisotope extraction system, and SNM processing and storage.

4b.2 Summary of Application

The summary provided in SER Section 4a.2, “Summary of Application,” applies to both the IUs 

and the RPF.

4b.3 Regulatory Basis and Acceptance Criteria

The regulatory basis and acceptance criteria provided in SER Section 4a.3, “Regulatory Basis 

and Acceptance Criteria,” applies to both the SHINE IF and RPF.

4b.4 Review Procedures, Technical Evaluation, and Evaluation Findings

The staff performed an evaluation of the technical information presented in SHINE PSAR 

Section 4b to assess the sufficiency of the preliminary design and performance of SHINE’s RPF 

for the issuance of a construction permit, in accordance with 10 CFR 50.35(a). The sufficiency 

of the preliminary design and performance of SHINE’s RPF is demonstrated by following 

applicable regulatory requirements, guidance, and acceptance criteria, as discussed in 

Section 4a.3 of this SER. A summary of this technical evaluation is described in SER 

Section 4b.5, “Summary and Conclusion.”

For the purposes of issuing a construction permit, the preliminary design of the SHINE RPF may 

be adequately described at a functional or conceptual level. The staff evaluated the sufficiency 

of the preliminary design of the SHINE RPF based on the applicant’s design methodology and 

ability to provide reasonable assurance that the final design will conform to the design bases 

with adequate margin for safety. As such, the staff’s evaluation of the preliminary design of 

SHINE’s RPF does not constitute approval of the safety of any design feature or specification. 

Such approval will be made following the evaluation of the final design of SHINE’s RPF, as

described in the FSAR, as part of SHINE’s operating license application.

4b.4.1 Facility and Process Description

The staff evaluated the sufficiency of SHINE’s facility and process description of its RPF, as 

described in SHINE PSAR Section 4b.1, “Facility and Process Description,” using the guidance 

and acceptance criteria from Section 4b.1, “Facility and Process Description,” of the ISG 

Augmenting NUREG-1537, Parts 1 and 2.

Consistent with the review procedures of Section 4b.1 of the ISG Augmenting NUREG-1537, 

Part 2, the information submitted in SHINE PSAR Section 4b.1 is descriptive in nature and 

requires no technical analysis. The information in this section served as background for more 
Irradiation Units and Radioisotope Production Facility Description

4-33

detailed descriptions in later sections of the application. However, the staff considered whether 

the information presented in this section was consistent with other sections of the application.

SHINE PSAR Section 4b.1 contains a summary description of the RPF. It includes the principal 

safety considerations that were factored into the RPF design, construction, and operation. The 

design bases and functions of the systems and components are presented in sufficient detail to 

allow a clear understanding and to ensure that the RPF can be operated for its intended 

purpose and within regulatory limits for ensuring the health and safety of the operating staff and 

the public. Drawings and diagrams are provided to allow a clear and general understanding of 

the physical RPF features and of the processes involved. The primary function of the facility is 

to extract, purify, package, and ship medical radioisotopes. The primary fission product barrier 

in the RPF consists of vessels and associated piping, which contain the irradiated SNM and 

fission products (in solid, liquid or gaseous form) during the separation process.

The summary includes the names, amounts, and chemical and physical forms of the SNM that 

will be in process. The SHINE PSAR includes a list of byproduct materials (identity and 

amounts) in the RPF process solutions, finished products, and wastes from the process.

The SHINE PSAR also includes a detailed description of the design and construction of the 

equipment that will be used while processing SNM outside the IF. It includes enough detail to 

identify materials that may have moderating, reflecting, or other nuclear-reactive properties.

The summary describes the chemical and physical forms of SNM in process, including the 

maximum amounts of SNM in process in various building locations.

The SHINE PSAR presents a summary description of the raw materials, byproducts, wastes, 

and finished products of the RPF. This information includes data on expected levels of trace 

impurities or contaminants (particularly fission products or transuranic elements) characterized 

by identity and concentration.

The SHINE PSAR contains a general description of the design basis and implementation of any 

criticality safety features of the RPF for establishing and maintaining a nuclear criticality safety 

program. The staff evaluation of the criticality safety program is discussed in more detail in 

Section 6b.4.5, “Nuclear Criticality Safety,” of this SER.

The SHINE PSAR contains a description of the design basis and implementation of any 

hazardous chemical safety features of the RPF for establishing and maintaining a hazardous 

chemical safety program. The staff evaluation of the chemical safety program is discussed in 

more detail in Section 13b.4.1, “Processes Conducted Outside of the Irradiation Facility” and 

Section 13b.4.10, “Analyses of Accidents with Hazardous Chemicals Produced from Licensed 

Material,” of this SER.

Based on the information provided in SHINE PSAR Section 4b.1, the staff finds that the 

summary description of the facility and process of the SHINE RPF meets the acceptance criteria 

of the ISG Augmenting NUREG-1537 for the issuance of a construction permit in accordance 

with 10 CFR 50.35 and 50.40.
Irradiation Units and Radioisotope Production Facility Description

4-34

4b.4.2 Radioisotope Production Facility Biological Shield

The staff evaluated the sufficiency of SHINE’s RPF biological shield, as described in SHINE 

PSAR Section 4b.2, “Radioisotope Production Facility Biological Shield,” using the guidance 

and acceptance criteria from Section 4b.2, “Processing Facility Biological Shield,’’ of the ISG 

Augmenting NUREG-1537, Parts 1 and 2, which refers to Section 4.4, “Biological Shield,” of 

NUREG-1537, Parts 1 and 2.

Consistent with the review procedures of Section 4.4 of NUREG-1537, Part 2, the staff 

considered whether the objectives of the shield design bases are sufficient to protect the health 

and safety of the public and the facility staff, and that the design achieves the design bases.

SHINE PSAR 4b.2 states the production facility biological shield provides a barrier to protect 

SHINE facility personnel, members of the public, and various components and equipment of the 

SHINE facility by reducing radiation exposure. The RPF receives the irradiated target solution 

from the IU cell and distributes the target solution to various downstream processes. The target 

solution has a fission product activity that is defined in SHINE PSAR Chapter 11. The major 

areas outside of the IU cell that the target solution and by-product material occupy are as 

follows: Supercell (for molybdenum [Mo] extraction, purification, and packaging); Process 

tanks; Pipe chases; Waste processing cells; UREX cell; Thermal denitration (TDN) cell; Pump 

room hot cell; PVVS cell; and NGRS shielded cell.

SHINE PSAR Section 4b.2.2, “Biological Shield Design Basis,” describes the shield design, 

which includes a detailed description of the design and construction of the RPF biological shield. 

The shielding design basis, including calculations that were used to prescribe the required form 

and substance of the shield, are provided. The shield design also describes the functional 

design of the biological shield, showing entry and exit facilities for products, wastes, process 

equipment, and operating staff.

SHINE PSAR 4b.2.3.3 states “[t]he biological shield requires a number of penetrations, inserts, 

and other features where the bulk shielding materials are reduced in thickness, or where the 

materials used in the penetration are less dense than the surrounding bulk material. Each 

penetration is designed with well-demonstrated techniques of non-linear paths, supplemental 

shielding, location in areas of low-incident radiation, and other methods to reduce streaming and 

leakage to ensure 10 CFR Part 20 limits are met.”

SHINE PSAR Section 9a.2.1.1, “Radiologically Controlled Area Ventilation System,” includes a 

detailed description of the ventilation system for the biological shield structure, including: (1) the 

design basis and function; (2) the design and location of vent ducting, filters, and fans; 

(3) details on vent system operating limits under both normal and emergency operating 

conditions; and (4) the design basis and function of all filtering and sequestration systems 

provided to control release of particulate and gaseous airborne radioactive contaminants to the 

environment under normal and emergency operating conditions. The RPF hot cells are 

ventilated with systems that are independent of the occupied zone ventilations. RPF hot cells 

are isolated from the building heating, ventilation, and air conditioning system upon detection of 

a leak, to prevent the spread of contamination.

The staff notes that all of the essential physical and operational features of the biological shield 

that are required to prevent the release of radioactive material and to maintain radiation levels 

below applicable radiation exposure limits prescribed in 10 CFR Part 20 for the protection of the 

facility personnel and the public are identified in SHINE PSAR Section 4b.2, and will be included 
Irradiation Units and Radioisotope Production Facility Description

4-35

in the technical specifications that will be provided in SHINE FSAR Chapter 14, “Technical 

Specifications.”

On the basis of its review, the staff determined that the biological shield analysis in the SHINE 

PSAR offers reasonable assurance that the shield designs will limit exposures from the RPF 

sources of radiation so as not to exceed the limits of 10 CFR Part 20 and the guidelines of the 

facility ALARA program. The design offers reasonable assurance that the shield can be 

successfully installed with no radiation streaming or other leakage that would exceed the limits 

of 10 CFR Part 20 and the guidelines of the facility ALARA program. RPF components are 

sufficiently shielded to avoid significant radiation-related degradation or malfunction. Limiting 

conditions for operation and surveillance requirements for the shield will be included in technical 

specifications to be provided in Chapter 14 of the SHINE FSAR.

Based on the information provided in SHINE PSAR Section 4b.2, the staff finds that the 

description of the biological shield of the SHINE RPF meets the acceptance criteria of 

NUREG-1537 and the ISG Augmenting NUREG-1537 for the issuance of a construction permit 

in accordance with 10 CFR 50.35 and 50.40.

4b.4.3 Radioisotope Extraction System

The staff evaluated the sufficiency of SHINE’s RPF Radioisotope Extraction System, as 

described in SHINE PSAR Section 4b.3, “Radioisotope Extraction System,” using the guidance 

and acceptance criteria from Section 4b.3, “Radioisotope Extraction System,” of the ISG 

Augmenting NUREG-1537, Parts 1 and 2.

Consistent with the review procedures of Section 4b.3 of the ISG Augmenting NUREG-1537, 

Part 2, the staff considered whether the information provided a clear understanding of the 

processes and is consistent with the information in other sections of the PSAR (e.g., accident 

analyses, engineered safety features, technical specifications).

SHINE PSAR Section 4b.3 provides the design, detailed description and the following 

processing details about the MEPS:

• Process description, including process functions; safety functions; primary system 

interfaces; the process sequence, including molybdenum extraction and concentration 

and purification process sequences; and process equipment.

• Physical, chemical, and radioisotope properties of the target solution, including 

(proprietary) volumes in process and (proprietary) radioactive inventory in process.

• Criticality control features of the MEPS, provided through inherently safe geometrical 

design of MEPS equipment.

• Shielding and radiological protection features of the MEPS. The MEPS processes will 

be performed in shielded hot cells, which keeps worker exposure to radiation within the 

regulatory limits of 10 CFR 20.1201 and 20.1301. The processes are remotely, 

manually controlled, and performed with tele-manipulators, with minimal automated 

sequences. Radiation monitors and alarms are used to monitor release of radiological 

materials, monitor high background gamma dose levels, and to detect criticality events. 

Piping that contains potentially-radiological material is routed through shielded pipe 
Irradiation Units and Radioisotope Production Facility Description

4-36

chases to limit the worker exposure to radiation. Tanks within the MEPS are inside 

shielded hot cells, so additional tank shielding is not required.

On the basis of its review, the staff determined that the MEPS process descriptions in SHINE 

PSAR Section 4b.3 provide a detailed account of the SNM in process, along with any included 

fission-product radioactivity. The description of the post-irradiation processing after the target 

solution is removed from the IF gives a clear understanding that these operations can be 

conducted safely in this facility. The MEPS processing facilities and apparatus are described in 

sufficient detail to provide confidence that the SNM and byproduct material can be controlled 

throughout the process so that the health and safety of the public will be protected. The 

criticality control measures provided throughout the MEPS process are consistent with a 

double-contingency principal, and the MEPS provides suitable defense-in-depth for the 

contained processes. The double contingency principle is defined in 10 CFR 70.4, “Definitions,” 

to mean “that process designs should incorporate sufficient factors of safety to require at least 

two unlikely, independent, and concurrent changes in process conditions before a criticality 

accident is possible.” ANSI/ANS-8.1-1983, “Nuclear Criticality Safety in Operations with 

Fissionable Materials Outside Reactors,” further provides that “[p]roper application of the double 

contingency principle provides assurance that no single error or loss of a control will lead to the 

possibility of a criticality accident.”

Sufficient engineered safety features have been developed that provide safe margins for all 

safety-related process variables. The staff notes that SHINE PSAR Section 4b.3 provides a 

complete description, including diagrams and drawings, in sufficient detail to give a clear 

understanding of the extraction and purification process and how the process can be performed 

safely within regulatory limits. 

Based on the information provided in Section 4b.3 of the SHINE PSAR, the staff finds that the 

description of SHINE’s Radioisotope Extraction System meets the acceptance criteria of ISG 

Augmenting NUREG-1537 for the issuance of a construction permit in accordance with 

10 CFR 50.35 and 50.40.

4b.4.4 Special Nuclear Material Processing and Storage

SHINE PSAR Section 4b.4 describes the processing components and procedures involved in 

handling, processing, and storing SNM. The processing and storage of SNM is conducted in 

the production facility building and the waste staging and shipping building. SNM is used 

throughout the radiologically controlled area in both unirradiated and irradiated forms for the 

production of medical radioisotopes. Mo-99 is extracted from the irradiated SNM in the MEPS. 

Following Mo-99 extraction, the processing of irradiated SNM is performed in the UNCS. When 

cleanup of solution is required, the UNCS converts spent target solution in the form of uranyl 

sulfate into uranyl nitrate, separates the uranium from fission products and transuranic isotopes 

in the UREX process, and recovers uranium in the form of uranium oxide in the TDN process. 

The uranium oxide is loaded into cans and then returned to the target solution preparation 

system. Irradiated SNM is stored in criticality-safe tanks between irradiation cycles. 

SHINE PSAR Section 4b.4.1, “Processing of Irradiated Special Nuclear Material,” discusses the 

processing of irradiated SNM in greater detail.
Irradiation Units and Radioisotope Production Facility Description

4-37

Processing of Irradiated Special Nuclear Material

The staff evaluated the sufficiency of the SHINE RPF irradiated SNM processing and storage, 

as described in SHINE PSAR Section 4b.4.1, “Processing of Irradiated Special Nuclear 

Material,” using the guidance and acceptance criteria from Section 4b.4.1, “Processing of 

Irradiated Special Nuclear Material,” of the ISG Augmenting NUREG-1537, Parts 1 and 2.

Consistent with the review procedures of Section 4b.4.1 of the ISG Augmenting NUREG-1537, 

Part 2, the staff considered whether the information provided a clear understanding of the 

processes and is consistent with the information in other sections of the PSAR (e.g., accident 

analyses, engineered safety features, technical specifications).

SHINE PSAR Table 4b.4-1, “Estimated RPF Special Nuclear Material Inventory,” (non-public), 

specifies the chemical form, physical form, and inventory in pounds and kilograms. This 

information is not public because it is security-related information and withheld from public 

disclosure in accordance with 10 CFR 2.390, “Public inspections, exemptions, requests for 

withholding.” Tables 4b.4-6 through 4b.4-11 list the physical and chemical properties of the 

recycled target solution, spent target solution, UREX feed, TDN feed, UREX raffinate, and TDN 

product.

SHINE PSAR Section 4b.4.1 presents a summary description of the processes. Figures 4b.4-1 

(proprietary), “Uranyl Nitrate Preparation (UNP) Process Flow Diagram,” 4b.4-2, “Uranium 

Extraction (UREX) Process Flow Diagram,” and 4b.4-3, “Thermal Denitration (TDN) Process 

Flow Diagram,” present process flow diagrams of the uranyl nitrate preparation, uranium 

extraction, and TDN processes, respectively. This information includes data on expected levels 

of radioactivity, broken down by radionuclide (particularly volatile and long-lived fission products 

and transuranic elements). The radionuclide inventory is projected with decay time and 

tabulated at various times throughout the process. The description identifies points in the 

process where major separations are performed and describes the pathways of the separated 

radionuclides and other constituents.

SHINE PSAR Section 4b.4.1, along with Figures 4b.3-1, “Molybdenum Extraction Process Flow 

Diagram,” through 4b.4-7, “Uranium Metal/Oxide Storage Rack Assembly,” provide a clear 

description of the process systems and components to allow a good understanding that the 

facility can be operated safely within regulatory limits. The processing components are 

compatible with the process material contained to withstand the effects of corrosion and 

radiation. The processing system is designed to manage fission-product and radiolysis gases 

that evolve in the process.

SHINE PSAR Section 4b.4.1.3, “Criticality Control Features,” states that the UNCS prevents 

inadvertent criticality through the inherently-safe design of equipment that handles the irradiated 

SNM. A detailed description of the Criticality Safety Program is provided in SHINE PSAR 

Section 6b.3, “Nuclear Criticality Control.”

SHINE PSAR Section 4b.4.1.2.2, “Hazardous Material,” and Table 4b.4-12, “UNCS Hazardous 

Chemicals Inventory,” identify hazardous chemicals that are used in the UNCS process. SHINE 

will have chemical inventory controls, including separation of chemicals based on the potential 

for exothermic reactions. These controls, in addition to procedures controlling the processing of 

irradiated SNM, will include measures to prevent accidents. These procedures and controls will 

be described in the FSAR. All of the essential physical and operational features of the 

irradiated SNM processing system that are required to prevent the release of radioactive 
Irradiation Units and Radioisotope Production Facility Description

4-38

material and to maintain radiation levels below applicable radiation exposure limits prescribed in 

10 CFR Part 20, for the protection of the staff and the public, will be identified and included in 

the technical specifications in SHINE FSAR Chapter 14.

On the basis of its review, the staff determined that the process descriptions in SHINE PSAR 

Section 4b.4.1, together with the included tables and figures, provide a detailed account of the 

SNM in process along with fission-product radioactivity. The process descriptions for the uranyl 

nitrate preparation, UREX, and TDN processes are sufficient to provide a clear understanding 

that these operations can be conducted safely in the RPF. The staff determined that the UNCS 

processing facilities and apparatus have been described in sufficient detail to provide 

confidence that the SNM and byproduct material can be controlled throughout the process so 

that the health and safety of the public will be protected. The staff determined that the criticality 

control measures provided are consistent with the double-contingency principal, and the UNCS 

processing facility provides suitable defense-in-depth for the contained processes.

Based on the information provided in Section 4b.4.1 of the SHINE PSAR, the staff finds that the 

description of SHINE RPF irradiated SNM processing and storage meets the acceptance criteria 

of ISG Augmenting NUREG-1537 for the issuance of a construction permit in accordance with 

10 CFR 50.35.

4b.4.5 Processing of Unirradiated Special Nuclear Material

The staff evaluated the sufficiency of the SHINE RPF unirradiated SNM processing and storage, 

as described in SHINE PSAR Section 4b.4.2, “Processing of Unirradiated Special Nuclear 

Material,” using the guidance and acceptance criteria from Section 4b.4.2, “Processing of 

Unirradiated Special Nuclear Material,” of the ISG Augmenting NUREG-1537, Parts 1 and 2.

Consistent with the review procedures of Section 4b.4.2 of the ISG Augmenting NUREG-1537, 

Part 2, the staff considered whether the information provided a clear understanding of the 

processes and is consistent with the information in other sections of the PSAR (e.g., accident 

analyses, engineered safety features, technical specifications).

SHINE PSAR Section 4b.4.2 states that unirradiated SNM will be received in the form of low 

enriched uranium metal. Shipments of SNM will be received at the facility in solid form from a 

U.S. Department of Energy supplier. The shipments will consist of uranium metal enriched to 

19.75 ± 0.2 percent U-235. The SNM will be manually transported in approved transport 

containers and stored criticality-safe in those containers consistent with packaging limitations for 

use. The approved transport container is an NRC-licensed Type B shipping package. The 

SNM will be manually transferred to the uranium metal receipt area and removed from the 

transport containers and stored in uranium metal storage cans in criticality-safe configuration 

within the uranium metal storage rack. During the receipt process, the uranium metal receipt 

inspections will be performed. The uranium metal will be dissolved in nitric acid within the 

uranium metal dissolution tank (1-TSPS-02T) to provide makeup solution for uranium losses 

within the process. Once dissolution is complete, the uranyl nitrate solution will be transferred 

to the recycle uranyl nitrate hold tank (1-UNCS-06T) for further processing and conversion to 

uranium oxide by the thermal denitrator (1-UNCS-08T). The uranium oxide produced from the 

dissolution of unirradiated uranium metal will be stored in uranium oxide storage cans in 

criticality-safe configuration within the uranium oxide storage rack in the uranium oxide storage 

area. Unirradiated SNM in the form of uranium oxide may be received for initial startup and 

recharging and will be stored in uranium oxide storage cans in criticality-safe configuration 
Irradiation Units and Radioisotope Production Facility Description

4-39

within the uranium oxide storage rack in the uranium oxide storage area. Uranium oxide will be 

stored for future production of uranyl sulfate target solution. 

SHINE PSAR Sections 4b.4.2.2, “Uranium Metal Receipt,” through 4b.4.2.5, “Uranium Oxide 

Storage,” describe the operations involving SNM before it is used as target solution in the IF. 

The process descriptions include detailed procedures used in each operation, including a 

description of the quantity, physical form and chemical form of the SNM involved in each 

operation, and enough detail to enable development and analysis of potential accident 

sequences in SHINE PSAR Chapter 13, “Accident Analysis.” 

SHINE PSAR Section 4b.4.2.6, “Unirradiated SNM Related Equipment,” describes process 

equipment associated with processing unirradiated SNM. System components are 

criticality-safe by design. The target solution hold tank glovebox, uranium receipt ventilation 

hood, and TDN interface glovebox will be designed and fabricated consistent with American 

Glovebox Society code AGS-G00-2007, “Guideline for Gloveboxes,” 2007. Nominal sizes and 

specifications of tanks, uranium metal storage rack, uranium oxide storage rack, uranium metal 

storage can, and uranium oxide storage can are provided in the proprietary version of SHINE 

PSAR Chapter 4. 

All of the essential physical and operational features of the unirradiated SNM processing system 

that are required to prevent the release of radioactive material and to maintain radiation levels 

below applicable radiation exposure limits prescribed in 10 CFR Part 20, for the protection of 

facility staff and the public, will be identified and included in the technical specifications in 

SHINE FSAR Chapter 14.

On the basis of its review, the staff determined that process descriptions in SHINE PSAR 

Section 4b.4 provide a detailed account of the SNM in process. Each operation with SNM in 

receipt, transport, storage and preparation for use is described in sufficient detail to show that 

there is reasonable assurance that these operations can be conducted safely. The storage, 

transport and processing facilities, and apparatus have been described in sufficient detail to 

provide confidence that the SNM can be controlled throughout the process so that the health 

and safety of the public will be protected. The criticality control measures provided are 

consistent with a double-contingency principal and the processing facility provides suitable 

defense-in-depth for the contained processes.

Based on the information provided in Section 4b.4.2 of the SHINE PSAR, the staff finds that the 

summary description of SHINE RPF unirradiated SNM processing and storage meets the 

applicable regulatory requirements and acceptance criteria of the ISG Augmenting 

NUREG-1537 for the issuance of a construction permit in accordance with 10 CFR 50.35.

4b.5 Summary and Conclusions

The staff evaluated the descriptions and discussions of SHINE’s RPF, as described in SHINE 

PSAR Section 4b, and finds that the preliminary design of SHINE’s RPF, including the principal 

design criteria, design bases, and information relative to materials of construction and general 

arrangements, provides reasonable assurance that the final design will conform to the design 

basis and meets all applicable regulatory requirements and acceptance criteria in or referenced 

in the ISG Augmenting NUREG-1537. 
Irradiation Units and Radioisotope Production Facility Description

4-40

On the basis of these findings, the staff has made the following conclusions for the issuance of 

a construction permit in accordance with 10 CFR 50.35 and 50.40:

(1) SHINE has described the proposed design of the IU, including, but not limited to, the 

principal architectural and engineering criteria for the design, and has identified the 

major features or components incorporated therein for the protection of the health and 

safety of the public.

(2) Further technical or design information required to complete the safety analysis of the 

IU may be reasonably left for later consideration in the FSAR.

(3) There is reasonable assurance that, taking into consideration the site criteria contained 

in 10 CFR Part 100, the proposed facility can be constructed and operated at the 

proposed location without undue risk to the health and safety of the public.

(4) There is reasonable assurance that: (i) the construction of the SHINE facility will not 

endanger the health and safety of the public, and (ii) construction activities can be 

conducted in compliance with the Commission’s regulations.

(5) The issuance of a permit for the construction of the facility would not be inimical to the 

common defense and security or to the health and safety of the public.
5-1

COOLING SYSTEMS

The principal purpose of the cooling systems is to safely remove fission and decay heat from 

the target solution and dissipate it to the environment under normal and accident conditions. 

Cooling systems, including auxiliary and subsystems that use and contribute to the heat load of 

the primary or secondary cooling systems, should be shown to safely remove and transfer heat 

to the environment from all significant heat sources identified in the SHINE Medical 

Technologies, Inc. (SHINE or the applicant) Preliminary Safety Analysis Report (PSAR). The 

design of the cooling systems is based on interdependent parameters, including thermal power 

level, type and form of special nuclear material, neutronic physics, and radiation shielding.

This chapter of the SHINE construction permit safety evaluation report (SER) describes the 

review and evaluation of the U.S. Nuclear Regulatory Commission (NRC) staff (the staff) of the 

preliminary design of the SHINE irradiation facility (IF) and radioisotope production facility (RPF) 

cooling systems as presented in Chapter 5, “Cooling Systems,” of the SHINE PSAR, as 

supplemented by the applicant’s responses to requests for additional information (RAIs).

5a Irradiation Unit Cooling Systems

SER Section 5a, “Irradiation Unit Cooling Systems,” provides an evaluation of the preliminary 

design of SHINE’s irradiation unit (IU) cooling systems, as presented in SHINE PSAR 

Section 5a2, “Irradiation Unit Cooling Systems,” within which, SHINE describes the primary 

cooling system, secondary cooling system, primary coolant cleanup, primary coolant makeup 

water system, nitrogen-16 (N-16) control, and auxiliary systems using primary coolant.

5a.1 Areas of Review

SHINE PSAR Sections 5b, “Radioisotope Production Facility Cooling Systems,” and 5a2.3, 

“Secondary Cooling System,” describe the radioisotope process facility cooling system (RPCS), 

which serves as a secondary cooling system for the IUs and provides cooling to the RPF. 

Therefore, the areas of review related to the RPCS presented in this section are applicable to 

both the SHINE IUs and RPF.

The staff reviewed PSAR Section 5a, “Irradiation Unit Cooling Systems,” against applicable 

regulatory requirements using appropriate regulatory guidance and standards to assess the 

sufficiency of the preliminary design of the SHINE IU cooling systems. As part of this review, 

the staff evaluated descriptions and discussions of SHINE’s IU cooling systems, with special 

attention to design and operating characteristics, unusual or novel design features, and principal 

safety considerations. The preliminary design of SHINE’s IU cooling systems was evaluated to 

ensure the sufficiency of principal design criteria, design bases, and information relative to 

materials of construction, general arrangement, and approximate dimensions, sufficient to 

provide reasonable assurance that the final design will conform to the design bases. In 

addition, the staff reviewed SHINE’s identification and justification for the selection of those 

variables, conditions, or other items that are determined to be probable subjects of technical 

specifications for the facility, with special attention given to those items that may significantly 

influence the final design. The staff also considered the preliminary analysis and evaluation of 

the design and performance of the structures, systems, and components (SSCs) of the SHINE 

facility, including those SSCs shared by both the IF and RPF, with the objective of assessing the 

risk to public health and safety resulting from operation of the facility.
Cooling Systems

5-2

Areas of review for this section included IU primary and secondary cooling systems, primary 

coolant cleanup and makeup water systems, N-16 control, and auxiliary systems using primary 

coolant. Within these review areas, the staff assessed the following capabilities of SHINE’s IU 

cooling systems:

• The capability of the primary coolant system to remove fission and decay heat during 

normal operation, possible accident conditions and shut down, and transfer such heat to 

the secondary coolant system.

• The capability of the primary coolant system to provide shielding.

• The capability of the secondary coolant system to provide controlled heat dissipation to 

the environment.

• The capability of the primary coolant cleanup system to maintain high water quality to 

limit corrosion of essential components and the concentrations of particulates and 

dissolved contaminants that might become radioactive by neutron irradiation and to 

maintain high transparency of the water for observation of submerged operational and 

utilization components.

• The capability of the primary coolant makeup water system to replenish coolant, as 

necessary, to maintain operability.

• The capability of the primary coolant system to prevent uncontrolled leakage or 

discharge of contaminated coolant to the unrestricted environment.

• The capability of the primary coolant system to cool auxiliary systems, as required.

5a.2 Summary of Application

As stated above and described in SHINE PSAR Sections 5b and 5a2.3, the RPCS serves as a 

secondary cooling system for the IUs and provides cooling to the RPF. Therefore, the summary 

provided below applies to both the IF and RPF.

The IU cooling systems include the primary cooling system and secondary cooling system. The 

primary cooling system comprises the primary closed-loop cooling system (PCLS) and 

light-water pool system (LWPS). The PCLS and LWPS provide the heat removal to the IU 

equipment that is submerged within the light water pool. There are eight IUs and each of the 

IUs includes a PCLS and LWPS. The secondary cooling system is referred to as the RPCS. 

The RPCS removes heat from the LWPS/PCLS and transfers it to the facility chilled water 

supply and distribution system (FCHS). The RPCS is a closed loop system that provides 

cooling water to all of the process areas within the radiologically controlled area (RCA). The 

thermal partitions between the LWPS/PCLS and RPCS cooling systems are the heat 

exchangers at the system interfaces. The primary coolant cleanup loops provide treatment of 

the PCLS and LWPS coolant to meet water quality limits. The light water pool and primary 

closed loop cooling make-up system (MUPS) provides makeup water to the PCLS and LWPS 

cooling loops. In addition to providing secondary cooling function for the IF, the RPCS also 

provides cooling to the RPF. There is no independent N-16 control system. 
Cooling Systems

5-3

SHINE PSAR Section 5a provides the preliminary design of the SHINE IU cooling systems, 

including physical descriptions, design bases, process functions and operation, safety functions, 

interfaces, and probable subjects of technical specifications. There is no independent N-16 

control system and IU auxiliary systems are not cooled by the primary coolant system. The 

preliminary design of the SHINE IU cooling systems is supported by the following PSAR figures, 

which show flow paths between system components:

• Figure 5a2.1-1, “Cooling Systems Heat Flow Pathway Diagram.”

• Figure 5a2.2-1, “LWPS Process Flow Diagram.”

• Figure 5a2.2-2, “PCLS Process Flow Diagram.”

• Figure 5a2.4-1, “Primary Coolant Cleanup Loop Flow Diagram.”

Additionally, the following PSAR tables describe specifications, components, and interfaces of 

the IU cooling systems. The specifications provide nominal values for different parameters, and 

the component tables provide descriptions and the codes or standards to which the components 

are designed.

• Table 5a2.2-1, “PCLS Specifications.”

• Table 5a2.2-2, “LWPS Specifications.”

• Table 5a2.2-3, “PCLS and LWPS Components.”

• Table 5a2.2-4, “PCLS and LWPS System Interfaces.”

• Table 5a2.3-1, “RPCS Specifications.”

• Table 5a2.3-2, “RPCS Components.”

• Table 5a2.3-3, “RPCS Interfaces.”

• Table 5a2.5-1, “MUPS Specifications.”

5a.3 Regulatory Basis and Acceptance Criteria

As previously stated and described in SHINE PSAR Sections 5b and 5a2.3, the RPCS serves 

as a secondary cooling system for the IUs and provides cooling to the RPF. Therefore, the 

regulatory basis and acceptance criteria provided below apply to both the SHINE IF and RPF.

The staff reviewed SHINE PSAR Section 5a against applicable regulatory requirements, using 

appropriate regulatory guidance and standards, to assess the sufficiency of the preliminary 

design and performance of SHINE’s IU cooling systems for the issuance of a construction 

permit. In accordance with paragraph (a) of Title 10 of the Code of Federal Regulations

(10 CFR) 50.35, “Issuance of construction permits,” a construction permit authorizing SHINE to 

proceed with construction may be issued once the following findings have been made:

(1) SHINE has described the proposed design of the facility, including, but not limited to, 

the principal architectural and engineering criteria for the design, and has identified the 

major features or components incorporated therein for the protection of the health and 

safety of the public.

(2) Such further technical or design information as may be required to complete the safety 

analysis, and which can reasonably be left for later consideration, will be supplied in 

the final safety analysis report (FSAR).

(3) Safety features or components, if any, which require research and development have 

been described by SHINE and a research and development program will be conducted 
Cooling Systems

5-4

that is reasonably designed to resolve any safety questions associated with such 

features or components. 

(4) On the basis of the foregoing, there is reasonable assurance that: (i) such safety 

questions will be satisfactorily resolved at or before the latest date stated in the 

application for completion of construction of the proposed facility, and (ii) taking into 

consideration the site criteria contained in 10 CFR Part 100, “Reactor Site Criteria,” the 

proposed facility can be constructed and operated at the proposed location without 

undue risk to the health and safety of the public.

With respect to the last of these findings, the staff notes that the requirements of 

10 CFR Part 100 are specific to nuclear power reactors, and therefore not applicable to the 

SHINE facility. However, the staff evaluated SHINE’s site specific conditions using site criteria

similar to 10 CFR Part 100, by using the guidance in NUREG-1537, Part 1, “Guidelines for 

Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Format and 

Content,” issued February 1996 (Reference 4) and Part 2, “Guidelines for Preparing and 

Reviewing Applications for the Licensing of Non-Power Reactors, Standard Review Plan and 

Acceptance Criteria,” issued February 1996 (Reference 5). The staff’s review evaluated the 

geography and demography of the site; nearby industrial, transportation, and military facilities; 

site meteorology; site hydrology; and site geology, seismology, and geotechnical engineering to 

ensure that issuance of the construction permit will not be inimical to public health and safety.

The staff’s evaluation of the preliminary design of SHINE’s IU cooling systems does not 

constitute approval of the safety of any design feature or specification. Such approval will be 

made following the evaluation of the final design of SHINE’s IU cooling systems, as described in 

the FSAR, as part of SHINE’s operating license application.

5a.3.1 Applicable Regulatory Requirements

The applicable regulatory requirements for the evaluation of SHINE’s IU cooling systems are as 

follows:

• 10 CFR 50.34, “Contents of applications; technical information,” paragraph (a), 

“Preliminary safety analysis report.”

• 10 CFR 50.40, “Common Standards.”

• 10 CFR 20.1201, “Occupational dose limits for adults.”

• 10 CFR 20.1301, “Dose limits for individual members of the public.”

5a.3.2 Regulatory Guidance and Acceptance Criteria

In applying guidance and acceptance criteria, the staff used its judgment as to which 

acceptance criteria were relevant to SHINE’s proposed facility, as much of this guidance was 

originally developed for nuclear reactors. Given the similarities in SHINE’s proposed facility and 

non-power research reactors, the staff used established guidance documents and the 

Commission’s regulations to determine the acceptance criteria for demonstrating compliance 

with 10 CFR regulatory requirements. For example, the staff used the following: 
Cooling Systems

5-5

• NUREG-1537, Part 1, “Guidelines for Preparing and Reviewing Applications for the 

Licensing of Non-Power Reactors, Format and Content,” issued February 1996 

(Reference 4).

• 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 (Reference 5).

• “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 (Reference 6).

• “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 (Reference 7).

As stated in the ISG Augmenting NUREG-1537, the staff determined that certain guidance 

originally developed for heterogeneous non-power research and test reactors is applicable to 

aqueous homogenous facilities and production facilities. SHINE used this guidance to inform 

the design of its facility and prepare its PSAR. The staff’s use of reactor-based guidance in its 

evaluation of the SHINE PSAR is consistent with the ISG Augmenting NUREG-1537.

As appropriate, additional guidance (e.g., NRC regulatory guides, Institute of Electrical and 

Electronics Engineers [IEEE] standards, American National Standards Institute/American 

Nuclear Society [ANSI/ANS] standards) has been used in the staff’s review of SHINE’s PSAR. 

The use of additional guidance is based on the technical judgment of the reviewer, as well as 

references in NUREG-1537, Parts 1 and 2; the ISG Augmenting NUREG-1537, Parts 1 and 2; 

and the SHINE PSAR. Additional guidance documents used to evaluate SHINE’s PSAR are 

provided as references in Appendix B of this SER.

5a.4 Review Procedures, Technical Evaluation, and Evaluation Findings

As described in SHINE PSAR Sections 5b and 5a2.3, the RPCS serves as a secondary cooling 

system for the IUs and provides cooling to the RPF. The technical evaluation of this system 

provided below in Section 5a.4.3, “Secondary Cooling System,” applies to both the SHINE IF 

and RPF. The staff’s review of the RPCS considers the interface of this system between the IF 

and RPF.

The staff evaluated the technical information presented in SHINE PSAR Section 5a, as 

supplemented by the applicant’s responses to RAIs, to assess the sufficiency of the preliminary 

design and performance of SHINE’s IU cooling systems for the issuance of a construction 

permit, in accordance with 10 CFR 50.35(a). Additionally, the staff reviewed portions of 

sections throughout the PSAR that dealt with SSCs requiring cooling from the RPCS. The 

sufficiency of the preliminary design and performance of SHINE’s IU cooling systems is 

determined by ensuring the design and performance meet applicable regulatory requirements, 

guidance, and acceptance criteria, as discussed in Section 5a.3, “Regulatory Basis and 

Acceptance Criteria,” of this SER. A summary of the staff’s findings is in SER Section 5a.5, 

“Summary and Conclusion.”
Cooling Systems

5-6

For the purposes of issuing a construction permit, the preliminary design of the SHINE cooling 

systems may be adequately described at a functional or conceptual level. The staff evaluated 

the sufficiency of the preliminary design of the SHINE cooling systems based on the applicant’s 

design methodology and ability to provide reasonable assurance that the final design will 

conform to the design bases with adequate margin for safety. As such, the staff’s evaluation of 

the preliminary design of SHINE’s cooling systems does not constitute approval of the safety of 

any design feature or specification. Such approval will be made following the evaluation of the 

final design of SHINE’s cooling systems, as described in the FSAR, as part of SHINE’s 

operating license application.

5a.4.1 Summary Description

The staff evaluated the sufficiency of SHINE’s summary description of its IU cooling systems, as 

described in SHINE PSAR Section 5a2.1, “Summary Description,” using the guidance and 

acceptance criteria from Section 5.1, “Summary Description,” of NUREG-1537, Parts 1 and 2, 

and Section 5a2.1, “Summary Description,” of the ISG Augmenting NUREG-1537, Parts 1 

and 2.

As stated, in part, in Section 5a2.1 of the ISG Augmenting NUREG-1537, Part 2, the summary 

description of the cooling systems should include the type of coolant, type of cooling system, 

type of coolant flow in the primary and secondary cooling systems and the method of heat 

disposal to the environment, capability to provide sufficient heat removal for continuous 

operation at full licensed power, and any special or facility-unique features. SHINE PSAR 

Section 5a2.1 provides descriptions of the primary and secondary cooling systems, primary 

coolant cleanup and makeup water systems, and N-16 control.

Based on the information provided in Section 5a2.1 of the SHINE PSAR, the staff finds that the 

summary description of the SHINE IU cooling systems meets the applicable regulatory 

requirements and acceptance criteria of NUREG-1537 and ISG Augmenting NUREG-1537 for

the issuance of a construction permit in accordance with 10 CFR 50.35.

5a.4.2 Primary Cooling System

The staff evaluated the sufficiency of the preliminary design of SHINE’s primary cooling system, 

as described in SHINE PSAR Section 5a2.2, “Primary Cooling System,” in part, by reviewing the 

design basis, PCLS process functions, system process and safety functions, probable subjects 

of technical specifications, primary cooling system components and interfaces, PCLS cooling 

functions and operation, LWPS cooling functions and operation, instrumentation and sampling, 

secondary cooling system interaction, and radiation exposure protection using the guidance and 

acceptance criteria from Section 5.2, “Primary Coolant System,” of NUREG-1537, Parts 1 

and 2, and Section 5a2.2, “Primary Cooling System,” of the ISG Augmenting NUREG-1537, 

Parts 1 and 2.

Consistent with the review procedures of the ISG Augmenting NUREG-1537, Part 2, 

Section 5a2.2, the staff compared the preliminary design and operating characteristics of the 

primary cooling system with the bases for the design, as presented in SHINE PSAR 

Section 5a2.2 and other relevant chapters of the PSAR.

The ISG Augmenting NUREG-1537, Part 1, Section 5a2, “Aqueous Homogeneous Reactor 

[AHR] Cooling System,” states, in part, that “the applicant should give the design bases, 

descriptions, and functional analyses of the AHR cooling systems. The principal purpose of the 
Cooling Systems

5-7

cooling systems is to safely remove the fission heat and decay heat...and dissipate it to the 

environment.” As described in SHINE PSAR Section 5a2.2, each PCLS is designed to remove 

heat from each IU during full-power operation. The LWPS is also designed to remove heat from 

each IU during full-power operation. The light water pool is designed to passively remove decay 

waste heat (post-IU shut down) during design-basis accidents that result in a loss of PCLS and 

LWPS active cooling. A small amount of heat is also removed by the target solution vessel 

off-gas system. Based on the total heat load of the facility during normal operation and the 

thermal inertia of the light water pool, the staff finds the passive removal of decay heat 

sufficient. As such, active heat removal from the IUs is not required for emergency cooling.

The applicant stated that the RPCS provides cooling to both the IUs and the RPF and shutdown 

of the RPCS may leave some facility components without access to the passive cooling 

provided by the light water pools. For example, after shutdown of the IUs, hydrogen production 

will continue for some time at reduced rates and the off-gas condensers may require continued 

cooling. The applicant did not provide an analysis of this operational scenario and other 

scenarios that may require additional cooling. However, the NRC staff determined that since 

the RPCS does not support safety-related SSCs, the analysis can reasonably be deferred for 

consideration of a final design presented in the FSAR.

SHINE PSAR Section 5a2.2 provides a discussion of leak detection and allowable leakage 

limits, and specifies the inclusion of schematic and flow diagrams of the system, showing such 

essential components as the heat source, heat sink, pumps, piping, valves, control and safety 

instrumentation, interlocks, and other related subsystems.

In SHINE PSAR Section 5a2.2.9, “Secondary Cooling System Interaction,” Section 5a2.3.5, 

“RPCS Cooling Functions and Operation,” and Section 5a2.3.9, “Instrumentation and Control,” 

pressure, flow, temperature, conductivity, and radiation detection instrumentation are discussed, 

with pressure being the apparent measurement used to identify system leaks. The staff 

concluded that SHINE should provide additional information to enable the staff to evaluate the 

adequacy of pressure measurement to identify system leaks and to evaluate instrumentation for 

cooling system functions. Requested information addresses the acceptance criteria of the ISG 

Augmenting NUREG-1537, Part 2, Section 5a2.2, “Primary Cooling System,” related to the 

sufficiency of cooling system instrumentation, sensors, and control systems and demonstrate 

the adequacy of the design basis of the SHINE primary cooling system.

Therefore, in RAI 5a2.2-1 (Reference 14), staff asked the applicant to discuss the ability of 

pressure measurements to identify the presence of small leaks and address how the location of 

leaks would be determined.

In response to RAI 5a2.2-1 (Reference 20), the applicant stated that there were no plans to use 

pressure measurements to detect the presence of small leaks in the RPCS. The applicant 

stated that the pressure in the RPCS is greater than the pressure in the PCLS and LWPS to 

prevent the transfer of contaminated liquid in the event of a heat exchanger leak and the 

pressure measurement instrumentation on the PCLS, LWPS, and RPCS ensures that this 

function is maintained. An alarm will notify the operators if pressures for the PCLS, LWPS, or 

RPCS are outside of their allowable ranges.

SHINE stated that the location of small leaks out of the RPCS to the environment will be 

detected through one of the following methods:

• Rise in the level in the expansion tank (PCLS) or pool (LWPS) for that system over time.
Cooling Systems

5-8

• Periodic sampling and analysis for contaminants is performed on the PCLS and LWPS. 

The presence of contaminants (such as corrosion inhibitor agents from the RPCS) 

implies possible leakage and will be investigated.

• Visual detection during building walk downs of accessible areas.

The applicant stated that these three methods also assist in identifying a specific leaking heat 

exchanger or component. The staff finds this response addresses the acceptance criteria of the 

ISG Augmenting NUREG-1537, Part 2, Section 5a2.2, and demonstrates an adequate design 

basis for a preliminary design. The staff will confirm that the final design conforms to this design 

basis during the evaluation of SHINE’s FSAR.

In RAI 5a2.2-2 (Reference 14), the staff requested additional detail on the instrumentation for 

the cooling system functions to determine whether the intended functions are performed. This 

information was needed to address the acceptance criteria of the ISG Augmenting 

NUREG-1537, Part 2, Section 5a2.2, “Primary Cooling System,” related to the sufficiency of 

cooling system instrumentation, sensors, and control systems and demonstrate the adequacy of 

the design basis of the SHINE primary cooling system.

In response to RAI 5a2.2-2 (Reference 20), the applicant committed to install adequate 

instrumentation to identify and quantify leakage rates, including very small leaks. 

Instrumentation will have the capability to identify leak locations as they relate to allowable 

leakage limits and the safety functions of the systems. The details on the type and accuracy of 

the instrumentation will be provided in the FSAR. The staff finds this response addresses the 

acceptance criteria of the ISG Augmenting NUREG-1537, Part 2, Section 5a2.2, and 

demonstrates an adequate design basis for a preliminary design. The staff will confirm that the 

final design conforms to this design basis during the evaluation of SHINE’s FSAR.

SHINE PSAR Section 5a.2.2.2, “PCLS Process Functions,” indicates that water quality will be 

maintained to reduce corrosion and scaling, but this section does not indicate how this will be 

done. The staff determined that additional information was needed to evaluate the impact of 

potentially toxic additives used to maintain water quality on corrosion and scaling. Chemicals 

are commonly added to nuclear plant water systems to adjust nuclear reactivity (e.g., boric 

acid), to control pH (e.g., lithium hydroxide, ammonia/amines), to remove oxygen 

(e.g., hydrazine), or as a biocide (e.g., chlorine). 

Therefore, in RAI 5a2.2-3 (Reference 14), the staff requested that the applicant provide a list of 

all potentially toxic chemicals expected to be on the SHINE site for water quality control or for 

other purposes, including locations and quantities. This information is necessary to 

demonstrate the adequacy of the design basis of the SHINE primary cooling system and satisfy 

the acceptance criteria of the ISG augmenting NUREG-1537, Part 2, Section 5a2.2, which 

states, in part, that “[t]he primary coolant should provide a chemical environment that limits 

corrosion of the primary coolant barrier, control and safety rod surfaces, reactor vessels or 

pools, and other essential components.” 

In response to RAI 5a2.2-3 (Reference 20), the applicant stated that chemical additives will not 

be used in the primary coolant systems, the PCLS, or the LWPS. Filters and ion exchange 

resins will be used to remove contaminants and to maintain water quality parameters. As 

described in a letter dated October 4, 2013 (Reference 31), SHINE stated that the potentially 

toxic chemicals used to maintain water quality in the secondary water systems may include 

non-phosphate buffers (e.g., lithium hydroxide, boric acid, sodium sulfite, sodium lauroyl 
Cooling Systems

5-9

sarcosinate, or others to be determined during detailed design). The quantities of chemicals 

needed for the secondary water systems are expected to be small (i.e., less than 5 pounds), 

and will be stored in appropriate chemical storage areas, segregated from incompatible 

chemicals, consistent with Safety Data Sheets. The chemical storage areas are shown in 

PSAR Figure 1.3-2, “Production Building Floor Plans Preliminary Arrangement.” Toxic 

chemicals used for other purposes are described in PSAR Section 13b.3.2.2, “Chemical Source 

Term Analysis.” Those chemicals and amounts are provided in PSAR Table 13b.3-1, “Bounding 

Inventory [pounds] (lbs.) of Significant Process Chemicals.”

The staff finds this response satisfies the acceptance criteria of the ISG Augmenting 

NUREG-1537, Part 2, Section 5a2.2 and demonstrates an adequate design basis for a 

preliminary design. The staff will confirm that the final design conforms to design bases during 

the evaluation of SHINE’s FSAR.

On the basis of its review, the staff has determined that the level of detail provided on SHINE’s 

primary cooling system demonstrates an adequate design basis for a preliminary design and 

satisfies the applicable acceptance criteria of NUREG-1537, Part 2, Section 5a2.2, allowing the 

staff to make the following findings: (1) the primary cooling system and components provide

reasonable assurance of the maintenance of the system boundary integrity, (2) the system to 

remove fission heat from the IUs is sufficient, (3) the system has been designed to avoid a 

loss-of-coolant that would lead to system boundary failure, (4) appropriate passive cooling has 

been incorporated into the design, (5) the chemical quality of the primary coolant will limit 

corrosion, and (6) systems are present to control hydrogen concentrations.

Therefore, the staff finds that the preliminary design of the SHINE primary coolant system, as 

described in SHINE PSAR Section 5a2.2 and supplemented by the applicant’s responses to 

RAIs, is sufficient and meets the applicable regulatory requirements and guidance for the 

issuance of a construction permit in accordance with 10 CFR 50.35 and 50.40. Further 

technical or design information required to complete the safety analysis may reasonably be left 

for later consideration. The staff will confirm that all aspects of the final design conform to the 

design basis during the evaluation of SHINE’s FSAR.

5a.4.3 Secondary Cooling System

The staff evaluated the sufficiency of the preliminary design of SHINE’s secondary cooling 

system (RPCS), as described in SHINE PSAR Section 5a2.3, in part, by reviewing the design 

basis, process functions, RPCS components and interfaces, RPCS cooling functions and 

operation, cooling control, loss of cooling, component functions and locations; instrument and 

control; and other uses of the RPCS using the guidance and acceptance criteria from 

Section 5.3, “Secondary Coolant System,” of NUREG-1537, Parts 1 and 2, and 5a2.3, 

“Secondary Cooling System,” of the ISG Augmenting NUREG-1537, Parts 1 and 2.

Consistent with the review procedures of the ISG Augmenting NUREG-1537, Part 2, 

Section 5a2.3, the staff verified that all IU conditions requiring heat transfer from the PCLS to 

the RPCS have been discussed. The SHINE PSAR states that the RPCS is a 

non-safety-related system and is not needed in the event of an accident.

On the basis of its review, the staff has determined that the level of detail provided on the RPCS 

demonstrates an adequate design basis for a preliminary design and satisfies the applicable 

acceptance criteria of NUREG-1537, Part 2, Section 5a2.3, allowing the staff to make the 

following findings: (1) the design features of the RPCS will allow the transfer of the necessary 
Cooling Systems

5-10

heat from the primary cooling system, and (2) the location and design specifications of the 

RPCS ensure that malfunctions will not lead to IU or RPF damage.

Therefore, the staff finds that the preliminary design of the SHINE secondary cooling system, as 

described in SHINE PSAR Section 5a2.3, is sufficient and meets the applicable regulatory 

requirements and guidance for the issuance of a construction permit in accordance with 

10 CFR 50.35. The staff will confirm that the final design conforms to this design basis during 

the evaluation of SHINE’s FSAR.

5a.4.4 Primary Coolant Cleanup

Section 5a2.4, “Primary Coolant Cleanup,” identifies the process function and flows, and the 

cleanup loop components, control and instrumentation. The staff evaluated the sufficiency of 

the preliminary design of SHINE’s primary coolant cleanup system, as described in SHINE 

PSAR Section 5a2.4 by reviewing the design basis, process functions, process flow, system 

specifications, cleanup loop control and instrumentation, cleanup loop components, and 

maintenance and coolant testing of SHINE’s primary coolant cleanup system using the 

guidance and acceptance criteria from Section 5.4, “Primary Coolant Cleanup System,” of 

NUREG-1537, Parts 1 and 2, and Section 5a2.4, “Primary Coolant Cleanup System,” of the ISG 

Augmenting NUREG-1537, Parts 1 and 2.

Consistent with the review procedures of the ISG Augmenting NUREG-1537, Part 2, 

Section 5a2.4, the staff compared the design bases for the primary coolant water quality with 

the design bases by which the primary coolant cleanup system will achieve its requirements. 

The SHINE PSAR states that primary coolant cleanup system is part of the PCLS and 

light-water pool system and is not an independent system.

On the basis of its review, the staff has determined that the level of detail provided on the RPCS 

demonstrates an adequate design basis for a preliminary design and satisfies the applicable 

acceptance criteria of NUREG-1537, Part 2, Section 5a2.4, allowing the staff to make the 

following findings: (1) the design bases and functional descriptions of the primary water cleanup 

system provide reasonable assurance that the required water quality can be achieved; and 

(2) the system has been designed in accordance with the requirements of 10 CFR Part 20, 

“Standards for Protection Against Radiation,” and as low as is reasonably achievable (ALARA) 

program guidelines.

Therefore, the staff finds that the preliminary design of the SHINE IU primary coolant cleanup, 

as described in SHINE PSAR Section 5a2.4, is sufficient and meets the applicable regulatory 

requirements and guidance for the issuance of a construction permit in accordance with 

10 CFR 50.35. The staff will confirm that the final design conforms to this design basis during 

the evaluation of SHINE’s FSAR.
Cooling Systems

5-11

5a.4.5 Primary Coolant Makeup Water System

The staff evaluated the sufficiency of the preliminary design of SHINE’s MUPS, as described in 

SHINE PSAR Section 5a2.5, “Primary Coolant Makeup Water System,” in part, by reviewing 

design basis, process functions, process flow, design specifications, MUPS control and 

instrumentation, and MUPS components of SHINE’s primary coolant makeup water system 

using the guidance and acceptance criteria from Section 5.5, “Primary Coolant Makeup Water 

System,” of NUREG-1537, Parts 1 and 2, and Section 5a2.5, “Primary Coolant Makeup Water 

System,” of the ISG Augmenting NUREG-1537, Parts 1 and 2.

Consistent with the review procedures of the ISG Augmenting NUREG-1537, Part 2, 

Section 5a2.5, the staff compared the design bases and functional requirements for replenishing 

primary coolant, including the quantity and quality of water, the activities or functions that 

remove primary coolant, and the systems or procedures to accomplish water makeup with the 

acceptance criteria.

On the basis of its review, the staff has determined that the level of detail provided on the MUPS 

demonstrates an adequate design basis for a preliminary design and satisfies the applicable 

acceptance criteria of NUREG-1537, Part 2, Section 5a2.5, allowing the staff to make the 

following relevant findings: (1) The design bases, functional descriptions, and procedures for 

the MUPS give reasonable assurance that the quantity and quality of water required will be 

provided; (2) the system is designed to prevent overfilling of the primary cooling system; and 

(3) the system is designed to prevent contamination.

Therefore, the staff finds that the preliminary design of the SHINE MUPS, as described in 

Section 5a2.5 of the SHINE PSAR, is sufficient and meets the applicable regulatory 

requirements and guidance for the issuance of a construction permit in accordance with 

10 CFR 50.35. The staff will confirm that the final design conforms to this design basis during 

the evaluation of SHINE’s FSAR.

5a.4.6 Nitrogen-16 Control

The staff evaluated the sufficiency of the preliminary design of SHINE’s N-16 control, as 

described in SHINE PSAR Section 5a2.6, “Nitrogen-16 Control,” using the guidance and 

acceptance criteria of Section 5a2.6, “Nitrogen-16 Control,” of the ISG Augmenting 

NUREG-1537, Parts 1 and 2. As stated in SHINE PSAR Section 5a2.6, “[t]here is no 

independent N-16 control system. The radiation dose from N-16 is mitigated by the IU cell walls 

and shielding around the PCLS/LWPS components in the primary cooling enclosures and the 

administrative controls defined by the radiation protection program.” 

Consistent with the review procedures of the ISG Augmenting NUREG-1537, Part 2, 

Section 5a2.6, the staff evaluated the design basis of the systems that control personnel 

exposures to N-16 to confirm that an independent N-16 control system was not necessary.

On the basis of its review, the staff has determined that the level of detail provided on N-16 

control (i.e., proposed administrative controls and the preliminary design of the IU cell walls and 

shielding around the PCLS/LWPS) demonstrates an adequate design basis for a preliminary 

design and satisfies the applicable acceptance criteria of NUREG-1537, Part 2, Section 5a2.6. 

The staff finds that an independent N-16 system is not necessary. However, the design bases 
Cooling Systems

5-12

and features of those systems for N-16 control give reasonable assurance that those systems 

can function as proposed to reduce potential doses to personnel, meet 10 CFR Part 20 

requirements, and be consistent with the facility’s ALARA program.

Therefore, the staff finds that the proposed administrative controls and preliminary design of the 

SHINE IU cell walls and shielding, as described in Section 5a2.6 of the SHINE PSAR, is 

sufficient for N-16 control and meets the applicable regulatory requirements and guidance for

the issuance of a construction permit in accordance with 10 CFR 50.35. The staff will confirm 

that the final design conforms to this design basis during the evaluation of SHINE’s FSAR.

5a.4.7 Auxiliary Systems Using Primary Coolant

The staff evaluated the sufficiency of the preliminary design of SHINE’s auxiliary systems using 

primary coolant, as described in SHINE PSAR Section 5a2.7, “Auxiliary Systems Using Primary 

Coolant,” using the guidance and acceptance criteria of Section 5a2.7, “Auxiliary Systems Using 

Primary Coolant,” of the ISG Augmenting NUREG-1537, Parts 1 and 2. As stated in SHINE 

PSAR Section 5a2.7, “[t]he SHINE facility IU auxiliary systems do not utilize the primary cooling 

system for cooling duty. Therefore, this section does not apply to the SHINE facility.”

Consistent with the review procedures of the ISG Augmenting NUREG-1537, Part 2, 

Section 5a2.7, the staff verified that no auxiliary systems in which potentially damaging 

temperature increases or excessive radiation exposures were predicted, relied on cooling or 

shielding using primary coolant.

On the basis of its review, the staff has determined that, based on the preliminary design of the 

SHINE auxiliary systems, there are no auxiliary systems that require or utilize primary coolant 

for cooling duty. Therefore, the staff concluded that Section 5a2.7 of the ISG Augmenting 

NUREG-1537 does not apply to the SHINE facility. The staff will confirm that the final design 

maintains the separation of the auxiliary systems from the primary coolant, consistent with the 

design basis in the PSAR or an additional evaluation will be performed to verify the acceptance 

criteria in the ISG is met for the auxiliary system using primary coolant.

5a.4.8 Probable Subjects of Technical Specifications

In accordance with 10 CFR 50.34(a)(5), the staff evaluated the sufficiency of the applicant’s 

identification and justification for the selection of those variables, conditions, or other items 

which are determined to be probable subjects of technical specifications for the SHINE cooling 

systems, with special attention given to those items which may significantly influence the final 

design.

SHINE PSAR Section 5a2.2.4, “Technical Specification Operating Parameters,” states that 

“[t]here are no technical specification parameters identified for the PCLS or the LWPS.” PSAR 

Sections 5a2.3.3, “Technical Specification Operating Parameters,” and 5a2.4.4, “System 

Specifications,” indicate that there are no technical specification parameters identified for the 

RPCS, PCLS or the LWPS cleanup, also PSAR Section 5a2.4.4 states that “Tables 5a2.2-1 and 

5a2.2-2 [provide] specifications of the primary coolant cleanup system. The specifications in 

Tables 5a2.2-1 and 5a2.2-2 ensure normal operation of the primary coolant cleanup system 

without adversely affecting normal operation of other associated systems.”
Cooling Systems

5-13

However, the staff notes that SHINE identified potential limiting conditions for operation (LCOs) 

based on the flow and temperature of the PCLS, as well as the temperature and level of the 

LWPS in Table 14a2-1, “SHINE Facility Proposed Parameters for Technical Specifications.”

Based on the information provided in Sections 5a2.2.4, 5a2.3.3, and 5a2.4.4, as well as 

Table 14a2-1 of the SHINE PSAR, the staff finds that identification and justification of the 

proposed LCOs for the PCLS and LWPS is sufficient and meets the applicable regulatory 

requirements for the issuance of a construction permit in accordance with 10 CFR 50.35. A 

detailed evaluation of technical specifications, including LCOs and surveillance requirements,

will be performed during the review of SHINE’s operating license application.

5a.5 Summary and Conclusions

As described in SHINE PSAR Sections 5b and 5a2.3, the RPCS serves as a secondary cooling 

system for the IUs and provides cooling to the RPF. The summary and conclusions provided 

below apply to both the IF and RPF.

The staff evaluated descriptions and discussions of SHINE’s cooling systems, including 

probable subjects of technical specifications, as described in SHINE PSAR Section 5a and 

supplemented by the applicant’s responses to RAIs, and finds that the preliminary design of 

SHINE’s cooling systems, including the principal design criteria, design bases, and information 

relative to materials of construction, general arrangement, and approximate dimensions: 

(1) provides reasonable assurance that the final design will conform to the design basis, and 

(2) meets all applicable regulatory requirements and acceptance criteria in or referenced in 

NUREG-1537 and ISG Augmenting NUREG-1537. The staff further notes that the IUs are 

designed to operate with a minimal heat load during normal operation, which would promptly 

lessen by at least an order of magnitude following IU shut down. This, coupled with the 

absence of long-lived fission product build-up following shut down, indicates that operation of 

this facility would pose a minimal risk to the health and safety of the public.

On the basis of these findings, the staff has made the following conclusions for the issuance of 

a construction permit in accordance with 10 CFR 50.35 and 50.40:

(1) SHINE has described the proposed design of the cooling systems, including, but not 

limited to, the principal architectural and engineering criteria for the design, and has 

identified the major features or components incorporated therein for the protection of 

the health and safety of the public.

(2) Further technical or design information required to complete the safety analysis of the 

cooling systems may reasonably be left for later consideration in the FSAR.

(3) Taking into consideration the site criteria contained in 10 CFR Part 100, the proposed 

facility can be constructed and operated at the proposed location without undue risk to 

the health and safety of the public.

(4) There is reasonable assurance: (i) that the construction of the SHINE facility will not 

endanger the health and safety of the public, and (ii) that construction activities can be 

conducted in compliance with the Commission’s regulations.

(5) The issuance of a permit for the construction of the facility would not be inimical to the 

common defense and security or to the health and safety of the public.
Cooling Systems

5-14

5b Radioisotope Production Facility Cooling Systems

SER Section 5b, “Radioisotope Production Facility Cooling Systems,” provides an evaluation of 

the preliminary design of SHINE’s RPF cooling systems as presented in SHINE PSAR 

Section 5b, “Radioisotope Production Facility Cooling Systems.”

5b.1 Areas of Review

SHINE PSAR Sections 5b and 5a2.3 describe the RPCS, which serves as a secondary cooling 

system for the IUs and provides cooling to the RPF. Therefore, the areas of review related to 

the RPCS presented in SER Section 5a.1, “Areas of Review,” are applicable to both the SHINE 

IUs and RPF.

5b.2 Summary of Application

As stated above and described in SHINE PSAR Sections 5b and 5a2.3, the RPCS serves as a 

secondary cooling system for the IUs and provides cooling to the RPF. Therefore, the summary 

provided in SER Section 5a.2, “Summary of Application,” applies to both the IUs and RPF.

5b.3 Regulatory Basis and Acceptance Criteria

As previously stated and described in SHINE PSAR Sections 5b and 5a2.3, the RPCS serves 

as a secondary cooling system for the IUs and provides cooling to the RPF. Therefore, the 

regulatory basis and acceptance criteria provided in SER Section 5a.3, “Regulatory Basis and 

Acceptance Criteria,” apply to both the SHINE IF and RPF.

5b.4 Review Procedures, Technical Evaluation, and Evaluation Findings

As described in SHINE PSAR Sections 5b and 5a2.3, the RPCS serves as a secondary cooling 

system for the IUs and provides cooling to the RPF. The technical evaluation of this system is 

provided above in SER Section 5a.4.3, “Secondary Cooling System,” and applies to both the 

SHINE IF and RPF. The staff’s review of the RPCS considers the interface of this system 

between the IF and RPF as part of its technical evaluation. Since the RPCS is not considered 

safety-related, there was no identification of probable subjects of technical specifications for this 

system.

5b.5 Summary and Conclusions

As described in SHINE PSAR Sections 5b and 5a2.3, the RPCS serves as a secondary cooling 

system for the IUs and provides cooling to the RPF. The summary and conclusions provided in 

SER Section 5a.5, “Summary and Conclusions,” apply to both the IF and RPF.
6-1

ENGINEERED SAFETY FEATURES

Engineered safety features (ESFs) are active or passive features designed to mitigate the 

consequences of accidents and to keep radiological exposures to the public, the facility staff, 

and the environment within acceptable values at the SHINE Medical Technologies, Inc. (SHINE

or the applicant) irradiation facility (IF) and radioisotope production facility (RPF). The concept 

of ESFs evolved from the defense-in-depth philosophy of multiple layers of design features to 

prevent or mitigate the release of radioactive materials to the environment during accident 

conditions. The need for ESFs is determined by SHINE’s accident analysis.

This chapter of the SHINE construction permit safety evaluation report (SER) describes the 

review and evaluation of the U.S. Nuclear Regulatory Commission (NRC) staff (the staff) of the 

preliminary design of the SHINE IF and RPF ESFs as presented in Chapter 6, “Engineered 

Safety Features,” of the SHINE Preliminary Safety Analysis Report (PSAR), as supplemented 

by the applicant’s responses to requests for additional information (RAIs).

6a Irradiation Facility Engineered Safety Features

SER Section 6a, “Irradiation Facility Engineered Safety Features,” provides an evaluation of the 

preliminary design of SHINE’s IF ESFs, as presented in SHINE PSAR Section 6a2, “Irradiation 

Facility Engineered Safety Features,” within which, features designed to mitigate consequences 

of accidents and events in order to keep radiological exposures within acceptable values are 

described.

6a.1 Areas of Review

The staff reviewed PSAR Section 6a2 against applicable regulatory requirements using 

appropriate regulatory guidance and standards to assess the sufficiency of the preliminary 

design and performance of the SHINE IF ESFs. As part of this review, the staff evaluated 

descriptions and discussions of the SHINE IF ESFs, with special attention to design and 

operating characteristics, unusual or novel design features, and principal safety considerations. 

The preliminary design of the SHINE IF ESFs was evaluated to ensure the sufficiency of 

principal design criteria; design bases; and information relative to materials of construction, 

general arrangement, and approximate dimensions, sufficient to provide reasonable assurance 

that the final design will conform to the design basis. In addition, the staff reviewed SHINE’s 

identification and justification for the selection of those variables, conditions, or other items, 

which are determined to be probable subjects of technical specifications for the facility, with 

special attention given to those items which may significantly influence the final design.

Areas of review for this section included a summary description of the IF ESFs, as well as a 

detailed description of the IF confinement. Within these review areas, the staff assessed, in 

part, the design bases and functional descriptions of the required mitigative features of the 

confinement ESFs; drawings, schematic drawings and tables of important design and operating 

parameters, and specifications for confinement ESFs; necessary ESF equipment included as 

part of the confinement fabrication specifications; description of control and safety 

instrumentation, including locations and functions of sensors, readout devices, monitors and 

isolation components, as applicable; and the required limitations on the release of confined 

effluents to the environment.
Engineered Safety Features

6-2

6a.2 Summary of Application

PSAR Section 6a2.2.1.2, “Confinement Systems and Components,” provides additional details 

on the specific SSCs making up the confinement system for the IF. This includes information on 

the mitigation of uncontrolled releases occurring within an irradiation unit (IU) cell, target 

solution vessel off gas system (TOGS) shielded cell, and the tritium purification system (TPS) 

glovebox by the confinement system. PSAR Section 6a2.2.1.3, “Functional Components,” 

provides a brief description on the failure state of active components of the confinement system 

during upset conditions or in adverse conditions. This section also discusses single failure 

events, redundancy and independencies of design of systems, and components required to 

perform a safety function. PSAR Section 6a2.2.1.4, “Confinement Components,” identifies and 

provides details on the components associated with the secondary confinement barrier of the IU 

cells, TOGS shielded cell, or TPS glovebox. This section also provides references to design, 

fabrication, and testing codes that will be used for the development of components. PSAR 

Section 6a2.2.1.5, “Engineered Safety Feature Test Requirements,” describes general 

approaches to testing requirements and features for ESF components and systems. PSAR 

Section 6a2.2.1.6, “Design Basis,” provides a general discussion of codes and standards to be 

used for the SHINE facility and supporting ESFs with cross references to PSAR Chapter 3, 

“Design of Structures, Systems, and Components”; Chapter 4, “Irradiation Unit and 

Radioisotope Production Facility Description”; Chapter 7, “Instrument and Control Systems”;

Chapter 9, “Auxiliary Systems”; and Chapter 14, “Technical Specifications.” As discussed in 

SHINE PSAR Sections 6a2.2.2, “Containment,” and 6a2.3, “Emergency Cooling System,” the 

SHINE facility does not have a containment, nor does it have an emergency core cooling 

system.

Additionally, PSAR Table 6a2.1-1, “Summary of IF Design Basis Accidents and ESF Provided 

for Mitigation,” summarizes the three design-basis accidents (DBAs) mitigated by the 

confinement ESF, including a list of structures, systems, and components (SSCs) that provide 

an ESF.

6a.3 Regulatory Basis and Acceptance Criteria

The staff reviewed SHINE PSAR Section 6a2 against applicable regulatory requirements, using 

appropriate regulatory guidance and standards, to assess the sufficiency of the preliminary 

design and performance of the SHINE IF ESFs for the issuance of a construction permit. In 

accordance with paragraph (a) of Title 10 of the Code of Federal Regulations (10 CFR) 50.35, 

“Issuance of Construction Permits,” a construction permit authorizing SHINE to proceed with 

construction may be issued once the following findings have been made:

(1) SHINE has described the proposed design of the facility, including, but not limited to, 

the principal architectural and engineering criteria for the design, and has identified the 

major features or components incorporated therein for the protection of the health and 

safety of the public.

(2) Such further technical or design information as may be required to complete the safety 

analysis, and which can reasonably be left for later consideration, will be supplied in 

the final safety analysis report (FSAR).

(3) Safety features or components, if any, which require research and development have 

been described by SHINE and a research and development program will be conducted 
Engineered Safety Features

6-3

that is reasonably designed to resolve any safety questions associated with such 

features or components.

(4) On the basis of the foregoing, there is reasonable assurance that: (i) such safety 

questions will be satisfactorily resolved at or before the latest date stated in the 

application for completion of construction of the proposed facility, and (ii) taking into 

consideration the site criteria contained in 10 CFR Part 100, “Reactor Site Criteria,” the 

proposed facility can be constructed and operated at the proposed location without 

undue risk to the health and safety of the public.

With respect to the last of these findings, the staff notes that the requirements of 

10 CFR Part 100 are specific to nuclear power reactors, and therefore not applicable to the 

SHINE facility. However, the staff evaluated SHINE’s site specific conditions using site criteria 

similar to 10 CFR Part 100, by using the guidance in NUREG-1537. The staff’s review 

evaluated the geography and demography of the site; nearby industrial, transportation, and 

military facilities; site meteorology; site hydrology; and site geology, seismology, and 

geotechnical engineering to ensure that issuance of the construction permit will not be inimical 

to public health and safety.

The staff’s evaluation of the preliminary design of the SHINE IF ESFs does not constitute 

approval of the safety of any design feature or specification. Such approval will be made 

following the evaluation of the final design of the SHINE IF ESFs as described in the FSAR as 

part of SHINE’s operating license application.

6a.3.1 Applicable Regulatory Requirements

The applicable regulatory requirements for the evaluation of SHINE’s IF ESFs are as follows:

• 10 CFR 50.34, “Contents of applications; technical information,” paragraph (a), 

“Preliminary safety analysis report.”

• 10 CFR 50.40, “Common Standards.”

• 10 CFR 20.1201, “Occupational dose limits for adults.”

• 10 CFR 20.1301, “Dose limits for individual members of the public.”

6a.3.2 Regulatory Guidance and Acceptance Criteria

In applying guidance and acceptance criteria, the staff used its judgment as to which 

acceptance criteria were relevant to SHINE’s proposed facility, as much of this guidance was 

originally developed for nuclear reactors. Given the similarities in SHINE’s proposed facility and 

non-power research reactors, the staff used established guidance documents and the 

Commission’s regulations to determine the acceptance criteria for demonstrating compliance 

with 10 CFR regulatory requirements. For example, the staff used: 

• NUREG-1537, Part 1, “Guidelines for Preparing and Reviewing Applications for the 

Licensing of Non-Power Reactors, Format and Content,” issued February 1996 

(Reference 4).
Engineered Safety Features

6-4

• 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 (Reference 5). 

• “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 (Reference 6).

• “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 (Reference 7).

As stated in the ISG Augmenting NUREG-1537, the staff determined that certain guidance 

originally developed for heterogeneous non-power research and test reactors is applicable to 

aqueous homogenous facilities and production facilities. SHINE used this guidance to inform 

the design of its facility and prepare its PSAR. The staff’s use of reactor-based guidance in its 

evaluation of the SHINE PSAR is consistent with the ISG Augmenting NUREG-1537.

As appropriate, additional guidance (e.g., NRC regulatory guides, Institute of Electrical and 

Electronics Engineers (IEEE) standards, American National Standards Institute/American 

Nuclear Society (ANSI/ANS) standards) has been used in the staff’s review of SHINE’s PSAR. 

The use of additional guidance is based on the technical judgment of the reviewer, as well as 

references in NUREG-1537, Parts 1 and 2; the ISG Augmenting NUREG-1537, Parts 1 and 2; 

and the SHINE PSAR. Additional guidance documents used to evaluate SHINE’s PSAR are 

provided as references in Appendix B of this SER.

6a.4 Review Procedures, Technical Evaluation, and Evaluation Findings 

The staff performed an evaluation of the technical information presented in SHINE PSAR 

Section 6a2, as supplemented by the applicant’s responses to RAIs, to assess the sufficiency of 

the preliminary design and performance of the SHINE IF ESFs for the issuance of a 

construction permit, in accordance with 10 CFR 50.35(a). Sufficiency of the preliminary design 

and performance of the SHINE IF ESFs is determined by ensuring the design and performance 

meet applicable regulatory requirements, guidance, and acceptance criteria, as discussed in 

Section 6a.3, “Regulatory Basis and Acceptance Criteria,” of this SER. While the technical 

evaluation of these systems provided in this section is specific to the SHINE IF, the staff’s 

review considers the interface of these systems between the IF and RPF as part of its technical 

evaluation. A summary of the technical evaluation is described in SER Section 6a.5, “Summary 

and Conclusions.”

For the purposes of issuing a construction permit, the preliminary design of the SHINE IF ESFs 

may be adequately described at a functional or conceptual level. The staff evaluated the 

sufficiency of the preliminary design of the SHINE IF ESFs based on the applicant’s design 

methodology and ability to provide reasonable assurance that the final design will conform to 

the design bases with adequate margin for safety. As such, the staff’s evaluation of the 

preliminary design of the SHINE IF ESFs does not constitute approval of the safety of any 

design feature or specification. Such approval will be made following the evaluation of the final 

design of the SHINE IF ESFs, as described in the FSAR, as part of SHINE’s operating license 

application.
Engineered Safety Features

6-5

6a.4.1 Summary Description

The staff evaluated the sufficiency of SHINE’s summary description of its IF ESFs, as described 

in SHINE PSAR Section 6a2.1, “Summary Description,” and supplemented by the applicant’s 

responses to RAIs, using the guidance from Section 6.1, “Summary Description,” of 

NUREG-1537, Parts 1 and 2.

NUREG-1537, Part 1, Section 6.1, “Summary Description,” states:

In this section of the SAR, the applicant should briefly describe all of the ESFs in 

the facility design and summarize the postulated accidents they are designed to 

mitigate. These summaries should include the design bases and performance 

criteria and contain enough information for an overall understanding of the 

functions of the ESFs and the reactor conditions under which the equipment or 

systems must function.

Simple block diagrams and drawings may be used to show the location, basic 

function, and relationship of each ESF to the facility. Detailed drawings, 

schematic diagrams, data, and analyses should be presented in subsequent 

sections of this chapter for specific ESFs.

NUREG-1537, Part 2, Section 6.1, “Summary Description,” states:

In this section of the SAR, the applicant should briefly describe all the ESFs in 

the facility design and summarize the postulated accidents whose consequences 

could be unacceptable without mitigation. A specific postulated accident 

scenario should indicate the need for each ESF. The details of the accident 

analyses should be given in Chapter 13 of the SAR and the detailed discussions 

of the ESFs in Section 6.2 of the SAR. These summaries should include the 

design bases, the performance criteria, and the full range of reactor conditions, 

including accident conditions, under which the equipment or systems must 

maintain function.

The applicant may submit simple block diagrams and drawings that show the 

location, basic function, and relationship of each ESF to the facility. The 

summary description should contain enough information for an overall 

understanding of the functions and relationships of the ESFs to the operation of 

the facility. Detailed drawings, schematic diagrams, data, and analyses should 

be presented in Section 6.2 of the SAR for each specific ESF.

The ISG Augmenting NUREG-1537, Part 1, Section 6a2, “Aqueous Homogeneous Reactor 

Engineered Safety Features,” states, in part: “... the guidance in this section is general enough 

to apply to any type of reactor facility, as long as the unique features of each are addressed and 

appropriate ESFs are provided to ensure that operations are conducted within safe limits.”

The information in SHINE PSAR Section 6a2 forms the basis for evaluations performed in 

PSAR Chapter 13, “Accident Analysis.” PSAR Section 6a2.1 provides PSAR Table 6a2.1-1, 

which describes the ESFs required to maintain the confinement function during three design 

basis accidents (DBAs) analyzed in SHINE PSAR Chapter 13. However, the staff determined 

that while Section 6a2.1 of the SHINE PSAR contains a description of the ESFs for the IF, it did 

not contain enough information for an overall understanding of the functions of the ESFs.
Engineered Safety Features

6-6

Therefore, in RAI 6a2.1-1 (Reference 14), the staff requested that the applicant provide a 

description of the conditions under which ESFs must function; block diagrams and drawings to 

clarify the location, basic function, and the relationship of each ESF to the facility; whether the 

target solution preparation systems (TSPSs) are part of the IF or the RPF; and whether any 

valves or piping located in the target solution preparation system room are considered part of 

the confinement boundary for either or both the IF or the RPF.

In response to RAI 6a2.1-1 (Reference 21), the applicant stated the conditions under which the 

ESFs were required to operate included: mishandling or malfunction of target solution; 

mishandling or malfunction of equipment affecting the PSB; and Tritium Purification System 

(TPS) DBA. The postulated accidents could potentially result in releases of radioactive 

materials with high radiation fields in the IU cells, primary cooling (PCLS and LWPS) rooms, 

TOGS shielded cells, and TPS gloveboxes. Additionally, the applicant stated that structures 

and components will be designed to perform their confinement function under adverse 

conditions for the duration of the accident, including: expected radiation exposure levels, acidic 

chemical environment, and capable of performing in environments determined from the fire 

hazards analysis. Additionally, the applicant provided a new block diagram, PSAR Figure 

6a2.1-1-1, showing the basic function and relationship of the SSCs providing the confinement 

ESF in the IF to the facility, as well as the relationship between each ESF SSC in the 

confinement. The SSCs in providing in the confinement ESF are: IU cells, including penetration 

seals, RVZ1 ductwork up to bubble-tight isolation dampers, Bubble-tight isolation dampers, 

Isolation valves on piping systems penetration the IU cells, TOGS shielded cells, including 

penetration seals, Engineered Safety Features Actuation System (ESFAS), Double-walled pipe 

used for the TPS, TPS gloveboxes, and TPS confinement system. Further, the applicant stated 

the TSPS is part of the RPF and valves and piping located inside the TSPS room are not 

expected to be part of the confinement boundary for either the IF or the RPF.

The staff finds this response satisfies the acceptance criteria of NUREG-1537, Part 2, 

Section 6.1 and demonstrates adequate design criteria for a preliminary design. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

On the basis of its review, the staff has determined that the level of detail provided in the 

summary description of the SHINE IF ESFs demonstrates an adequate design basis for a 

preliminary design.

Therefore, the staff finds that the summary description of the SHINE IF ESFs, as described in 

SHINE PSAR Section 6a2.1, is sufficient and meets the applicable regulatory requirements and 

guidance for the issuance of a construction permit in accordance with 10 CFR 50.35. The staff 

will confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

6a.4.2 Confinement

The staff evaluated the sufficiency of the preliminary design of the SHINE confinement and 

related systems as described in SHINE PSAR 6a.2.2.1, “Confinement,” in part, by reviewing 

confinement mitigation requirements, the defined confinement envelope, and detailed 

descriptions of the ESFs associated with confinement. Additionally, the staff evaluated the 

passive and active ESF components, under normal and upset operational conditions. The 

functional requirements, design bases, probable subjects of technical specifications, and testing 

requirements were also evaluated for sufficiency.
Engineered Safety Features

6-7

Consistent with the review procedures of NUREG-1537, Part 2, Section 6.2.1, “Confinement,” 

the staff: (1) reviewed the accident scenarios analyzed in PSAR Chapter 13 and evaluated 

whether the confinement will sufficiently mitigate consequences; (2) reviewed design and 

functional bases against analyzed accidents; and (3) compared diffusion and dispersion of 

released airborne radionuclides.

SHINE PSAR, Section 6a2.2.1.2, “Confinement System and Components,” states, in part, that 

“[t]his ESF effectively reduces the amount of ductwork in the confinement volume that needs to 

remain intact to achieve IU cell, TOGS shielded cell, or TPS glovebox confinement.”

In RAI 6a2.2-2 (Reference 14), the staff asked the applicant to provide clarification regarding the 

meaning of this sentence.

In response to RAI 6a2.2-2 (Reference 20), the applicant stated, in part, that:

PSAR Section 6a2.2.1.2 provides a discussion of the IF confinement systems 

and components that help to mitigate the consequences of a potential accident. 

These confinement systems and components include bubble-tight isolation 

dampers that isolate the ductwork into and out of a confinement area following a 

confinement isolation signal resulting from high radiation. PSAR Figure 9a2.1-1 

shows typical cell isolation dampers adjacent to their respective cells. 

The applicant also stated, in part, that:

...[its] design locates the isolation dampers as close as practical to the 

confinement area. When the isolation dampers for a cell or glovebox close on 

the receipt of a confinement isolation signal, the spread of contamination is 

limited to that cell or glovebox plus the small amount of ductwork between the 

cell or glovebox and its isolation dampers. Ductwork downstream of an isolation 

damper therefore does not need to remain intact to achieve confinement of the 

IU cell, TOGS shielded cell, or TPS glovebox. Since contamination is prevented 

from spreading through the ventilation system, the total potential for leakage is 

reduced by minimizing the amount of ductwork in contact with contaminated 

material following a design basis accident.

The staff finds this response provides sufficient clarification of the aforementioned statement 

found in PSAR Section 6a2.2.1.2.

SHINE PSAR, Section 6a2.2.1.2, “Confinement System and Components,” states, in part, that 

“[a] failure of the TPS outside the glovebox is mitigated by the TPS confinement system. The 

TPS confinement system uses isolation valves to stop a tritium leak outside the glovebox when 

a leak is detected.” The staff needed additional information to determine the adequacy of the 

design of the TPS confinement system.

Therefore, in RAI 6a2.2-3 (Reference 14), the staff asked the applicant to provide additional 

information on the design and function of the TPS confinement system, including on the ability 

of the system to stop tritium leaks outside of the glovebox.

In response to RAI 6a2.2-3 (Reference 21), the applicant stated, in part, that:

...the TPS confinement system boundaries consist of: 
Engineered Safety Features

6-8

• the TPS gloveboxes, including the pressure protection bubbler and glovebox 

airlock; 

• the outer jacket of double-walled piping that transfers tritium outside of 

gloveboxes; and 

• the TPS confinement isolation valves that isolate portions of the tritium 

system upon loss of integrity to limit tritium releases.

The applicant further stated, in part, that:

...tritium outside the glovebox is contained in piping normally under vacuum, 

which assists in reducing the potential for releases. Pressure detection is 

expected be used to monitor for a leak in these lines, since an unexpected 

increase in pressure indicates a potential leak. Once the pressure rises past the 

allowable set points, isolation valves will close in order to reduce the potential 

amount of tritium released. The confinement isolation valve closure time will be 

accounted for in the accident analysis and the assumed value will be bounding. 

The only significant portion of the tritium inventory that is not in a confinement 

area or double-walled piping is the tritium in the neutron drivers. The evaluation 

of the release of tritium from the neutron drivers is described in Subsection 

13a2.2.12.3. Isolation valves will isolate the NDAS from the TPS should a leak in 

NDAS be detected. 

The applicant also stated that isolation valve locations will be determined during detailed 

design and provided in the FSAR. The staff finds this response provides sufficient detail 

regarding the TPS confinement system and demonstrates adequate design criteria for a 

preliminary design. Valve location details required to complete the evaluation may be 

reasonably left for later consideration and will be submitted in the FSAR. The staff will 

confirm that the final design conforms to this design basis during the evaluation of 

SHINE’s FSAR.

SHINE PSAR, Section 6a2.2.1.3, “Functional Requirements,” states, in part, “[a]ctive 

confinement components are designed to fail into a safe state if conditions such as loss of 

signal, loss of power, or adverse environments are experienced.” In order to determine the 

adequacy of the SHINE design to withstand and mitigate adverse environments, the staff 

needed additional information; therefore, in RAI 6a2.2-4 (Reference 14), the staff asked the 

applicant to provide information on the assumed “adverse environments” and how components 

are designed to accommodate for them.

In response to RAI 6a2.2-4 (Reference 21), the applicant stated, in part, that:

...the assumed adverse environments for the active confinement components in 

the IF are due to the release of radioactive materials. These assumed adverse 

environments are high radiation fields in the IU cells, primary cooling (PCLS and 

LWPS) rooms, TOGS shielded cells, and TPS gloveboxes, and acidic 

environments in the PCLS and LWPS. The active confinement components (e.g., 

isolation dampers, isolation valves) will be designed to perform their functions 

under the expected radiation conditions for the duration of the accident. The 

active confinement components that may be exposed to acidic environments 

(e.g., isolation valves on PCLS and LWPS) due to target solution release will be 

chemically compatible with the target solution. Except for dampers credited for 

isolation during postulated fires, ESF components in the IF are not expected to 
Engineered Safety Features

6-9

experience adverse temperature or pressure environments due to the low 

temperature and low pressure nature of the SHINE IF processes. Dampers that 

are credited to perform isolation functions during postulated fires will be capable 

of performing the required level of isolation in the potential environments (e.g., 

elevated temperature) determined from the FHA.

The staff finds this response provides sufficient detail regarding “adverse environments” and the 

method used to determine design of components. The staff finds this response demonstrates 

adequate design criteria for a preliminary design. The staff will confirm that the final design 

conforms to this design basis during the evaluation of SHINE’s FSAR.

SHINE PSAR, Section 6a2.2.1.3, “Functional Requirements,” states:

Mechanical, instrumentation, and electrical systems and components are 

designed to ensure that a single failure, in conjunction with an initiating event, 

does not result in the loss of the system’s ability to perform its intended safety 

function. The single failure considered is a random failure and any consequential 

failures in addition to the initiating event for which the system is required and any 

failures that are a direct or consequential result of the initiating event. 

To understand the meaning of the second sentence above, the staff needed additional 

information. Therefore, in RAI 6a2.2-5 (Reference 14), the staff asked the applicant to: 

(1) provide clarification regarding the meaning of the second sentence; and (2) provide the basis 

for how the system design meets the single-failure criterion stated, or provide the reference to 

the section of the PSAR, which describes that basis.

In response to RAI 6a2.2-5 (Reference 20), the applicant stated that PSAR Subsection 

6a2.2.1.3 contains an administrative error. SHINE subsequently revised this statement in the 

PSAR to read as follows:

Safety-related mechanical, instrumentation, and electrical systems and 

components are designed to ensure that a single failure of an active component, 

in conjunction with an initiating event, does not result in the loss of the system’s 

ability to perform its intended safety functions. The single failure considered is a 

random failure."

SHINE PSAR, Section 6a2.2.1.4, “Confinement Components,” discusses the “secondary

confinement barrier of the IU cells,” but does not define or fully describe this term. Therefore, in 

RAI 6a2.2-6 (Reference 14), the staff asked the applicant to explain precisely what comprises 

the “secondary confinement barrier of the IU cells.”

In response to RAI 6a2.2-6 (Reference 20), the applicant stated PSAR Section 6a2.2.1.4 

contains an administrative error. The facility has a primary and a secondary fission product 

barrier. The primary fission product barrier is the primary system boundary, while the secondary 

fission product barrier is designated the confinement boundary or barrier, or just confinement. 

The facility does not have a “secondary confinement barrier.” The use of the phrase “secondary 

confinement barrier” was an administrative error. SHINE has corrected this error in its PSAR.

SHINE PSAR, Section 6a2.2.1.4, “Confinement Components,” indicates that the details of the 

TPS confinement system will be left to the FSAR. To determine whether it is reasonable to 

provide details of the TPS confinement system in the FSAR, the staff needed additional 
Engineered Safety Features

6-10

information. Therefore, in RAI 6a2.2-7 (Reference 14), the staff asked the applicant to provide 

the rationale for leaving the details of TPS confinement to the FSAR.

In response to RAI 6a2.2-7 (Reference 21), the applicant noted that the TPS confinement 

system is described in the response to RAI 6a2.2-1. The applicant further provided that the 

details of the components that comprise the TPS are described in Subsection 9a2.7.1 of the 

PSAR. Isolation valve locations will be determined during detailed design and provided in the 

FSAR. The specific valve locations will be dependent on the final design and layout of the 

system. However, the applicant also states that valve locations and number will be sufficient to 

limit consequences from accidents to less than 10 CFR Part 20 limits. 

The staff finds this response is sufficient for a preliminary design. The staff will confirm that the 

final design conforms to this design basis during the evaluation of SHINE’s FSAR.

SHINE PSAR, Section 6a2.2.1.4, “Confinement Components,” mentions systems that are “open 

to the IU cell, TOGS shielded cell atmosphere, or TPS glovebox,” but does not identify them. 

Therefore, in RAI 6a2.2-8 (Reference 14), the staff asked the applicant to identify the systems 

that are open to the IU cell, TOGS shielded cell atmosphere, or TPS glovebox.

In response to RAI 6a2.2-8 (Reference 20), the applicant indicated that PSAR Subsection 

6a2.2.1.4 states, “For systems open to the IU cell, TOGS shielded cell atmosphere, or TPS 

glovebox, redundant isolation valves are provided.” The applicant indicated that this statement:

...describes the design requirement of the confinement system to ensure that no 

system creates a direct path from the atmosphere inside of the IU cell, TOGS 

shielded cell, or TPS glovebox to outside the cell or glovebox. A direct path 

would represent an unacceptable source of leakage from the respective 

confinement area during an accident, and proper isolation capability is required 

to ensure a complete confinement barrier. The sentence refers to systems that 

are normally open to the atmosphere, or may be open for maintenance or other 

operations when confinement capabilities are required (e.g., when an irradiated 

target solution batch is present in the IU cell, IU cell confinement capability is 

required). 

The applicant further stated, in part, that “based on preliminary design, the Light Water Pool 

System (LWPS) and RVZ1 are normally open systems to the IU cell atmosphere; RVZ1 is 

normally open to the TOGS shielded cell atmosphere; and RVZ1 and the nitrogen supply from 

the Inert Gas Control System (IGS) are connected to the TPS glovebox atmosphere.” 

The staff finds this response provides sufficient detail regarding the open systems for a 

preliminary design and it is reasonable to leave further details for submission as part of the final 

design in the FSAR. The staff will confirm that the final design conforms to this design basis 

during the evaluation of SHINE’s FSAR.

SHINE PSAR, Table 6a2.2-1, “Irradiation Facility Confinement Safety Functions” (page 6a2-9), 

references isolation valves on piping systems, but the applicant did not identify the valves, 

provide a list of the valves or reference a schematic which details the isolation valves. 

Therefore, in RAI 6a2.2-9 (Reference 14), the staff asked the applicant to provide a list, 

schematic or reference to a list of the isolation valves.
Engineered Safety Features

6-11

In response to RAI 6a2.2-9 (Reference 21), the applicant stated that PSAR Subsection 

6a2.2.1.4:

...describes confinement components of systems normally open to the IU cells, 

TOGS shielded cells, and TPS glovebox. The IU cells and TOGS shielded cells 

will have RVZ1 inlet and outlet bubble-tight isolation dampers to achieve the 

confinement boundary. A schematic of RVZ1 is shown in PSAR Figure 9a2.1-1. 

As shown in PSAR Figure 4a2.1-1, the IU cell has penetrations for the PCLS and 

LWPS. These systems provide cooling to the TSV, and both systems will be 

provided with isolation valves for confinement. TPS confinement is achieved by 

the TPS Confinement System. The TPS will also contain isolation valves. As 

described in the response to RAI 6a2.2-1, the necessary locations of isolations 

valves will be determined from the accident analysis during detailed design, and 

will include valves that isolate the NDAS from the TPS should a leak in NDAS be 

detected. Additional detail regarding the TPS isolation valves is also provided in 

the response to RAI 6a2.2-3. Additional isolation valve details will be developed 

during detailed design, and the FSAR will be updated with a list, details, or 

locations of these isolation valves. 

The staff finds this response is sufficient for a preliminary design and that it is reasonable to 

leave the requested details until the final design is submitted in the FSAR. The staff will confirm 

that the final design conforms to this design basis during the evaluation of SHINE’s FSAR.

NUREG-1537, Part 1, Section 6.2.1, “Confinement,” states, in part, that “[f]or the confinement to 

function as an ESF, the design bases for the consequence-mitigation functions should be 

derived from the accident analyses in SAR Chapter 13.” NUREG-1537, Part 2, Section 6.2.1, 

“Confinement,” Acceptance Criteria, states, in part, “[t]o be considered an ESF, design features 

must exist to mitigate the consequences of specific accident scenarios.”

SHINE PSAR, Section 6a2.2, “Irradiation Facility Engineered Safety Features Detailed 

Description,” contains a list of initiating events (IEs) that were included for the DBA review. The 

staff noted that a subsequent list identifies IEs, which do not have radiological consequences 

that require mitigation by ESFs. However, Section 6a2.2 did not explain the basis for the 

determination of which IEs do not have radiological consequences. Therefore, in RAI 6a2.2-10 

(Reference 14), the staff asked the applicant to provide the basis for this determination and a 

reference to the basis or analysis, which supports this determination or to the section(s) of 

SHINE PSAR that contain(s) such an analysis.

In response to RAI 6a2.2-10 (Reference 20), the applicant stated that the bases for the 

determination of which initiating events have radiological consequences are provided in 

Section 13a2.2 of the PSAR. SHINE has included a table in PSAR Section 6a2.2 that provides 

a reference to the FSAR Chapter 13 subsection where the specific radiological consequence 

analysis can be found for each initiating event. 

The staff finds this response satisfies the acceptance criteria of NUREG-1537, Part 2, 

Section 6.2.1 and demonstrates adequate design criteria for a preliminary design. It is 

reasonable to leave the requested details until the final design is submitted in the FSAR. The 

staff will confirm that the final design conforms to this design basis during the evaluation of 

SHINE’s FSAR.
Engineered Safety Features

6-12

NUREG-1537, Part 1, Section 6.2.1, “Confinement,” states, in part, “[t]he discussion of 

mitigative effects should contain a comparison of potential radiological exposures to the facility 

staff and the public with and without the ESF”

NUREG-1537, Part 2, Section 6.2.1, “Confinement,” Evaluation Findings, states, in part, that:

[t]his section of the SAR should contain sufficient information for the following 

types of conclusions, which will be included in the safety evaluation report:

• The scenarios for all potential accidents at the reactor facility have been 

analyzed by the applicant and reviewed by the staff. Mitigation of 

consequences by a confinement system has been proposed in the SAR 

analyses for any accident that could lead to potential unacceptable 

radiological exposures to the public, the facility staff, or the environment.

• The staff has reviewed the designs and functional descriptions of the 

confinement ESF; they reasonably ensure that the consequences will be 

limited to the levels found acceptable in the accident analyses of Chapter 13 

of the SAR.

• The designs and functional descriptions of the confinement ESF reasonably 

ensure that control of radiological exposures or releases during normal 

operation will not be degraded by the ESF.

SHINE PSAR, Section 6a2.2.1, “Confinement,” did not contain a comparison of potential 

radiological exposures to the facility staff and the public with and without the ESF. Therefore, in 

RAI 6a2.2-11 (Reference 14), the staff asked the applicant to provide the comparative study or 

reference the section of SHINE PSAR, which provides this information.

In response to RAI 6a2.2-11 (Reference 21), the applicant stated that PSAR Table 6a2.1-1 

“provides the IF DBAs that are mitigated by the IF confinement ESF. The IF maximum 

hypothetical accident (MHA) is also mitigated by the same confinement ESFs, as it is an 

extension of the mishandling or malfunction of target solution.” The applicant also provided 

PSAR Table 6a2.2-11-1, which contains a comparative study of the ESFs for mitigating these IF 

DBAs. For the unmitigated consequences, the applicant stated in part, that they “assumed 

none of the active ESFs functioned. The only active ESF components in the confinement 

credited for mitigating these accidents are the bubble-tight isolation dampers. The remaining 

assumptions and input values used to calculate the doses are the same between the 

unmitigated and mitigated cases. The unmitigated and mitigated radiation doses to workers at 

the SHINE facility are the same, as no active ESF components are credited in the accident 

analysis for the workers.”
Engineered Safety Features

6-13

Table 6a2.2-11-1. Comparison of Unmitigated and Mitigated

Radiological Doses for IF DBAs

Event

Unmitigated Public Dose (rem) Mitigated Public Dose (rem)

Site Boundary Nearest Resident Site Boundary Nearest Resident

TEDE Thyroid TEDE Thyroid TEDE Thyroid TEDE Thyroid

Target Solution

Release into the IU

Cell (IF Postulated

MHA)

1.65 1.58 2.30 × 10-1 2.21 × 10-1 1.65 × 10-2 1.58 × 10-2 2.30 × 10-3 2.21 × 10-3

Mishandling or

Malfunction of

Target Solution 2.19 × 10-1 1.58 3.06 × 10-2 2.21 × 10-1 2.19 × 10-3 1.58 × 10-2 3.06 × 10-4 2.21 × 10-3

Mishandling or

Malfunction of

Equipment Affecting 

the PSB

1.59 7.03 × 10-2 2.23 × 10-1 9.84 × 10-3 1.59 × 10-2 7.03 × 10-4 2.23 × 10-3 9.84 × 10-5

TPS Design

Basis 5.6 × 10-2 --- 8 × 10-3 --- 5.6 × 10-4 --- 8 × 10-5 ---

The applicant also indicated that the leak path factors in PSAR Chapter 13 for the DBA of the 

TPS were incorrect in relation to the provided doses and that it revised the TPS DBA described 

in PSAR Chapter 13 to correct the discrepancy and provide the reduced public doses. 

The staff finds this response satisfies the acceptance criteria of NUREG-1537, Part 2, 

Section 6.2.1 and demonstrates adequate design criteria for a preliminary design. It is 

reasonable to leave the requested details until the final design is submitted in the FSAR. The 

staff will confirm that the final design conforms to this design basis during the evaluation of 

SHINE’s FSAR.

NUREG-1537, Part 1, Section 6.2.1,”Confinement,” states, in part, that “[a] schematic diagram 

of the system should be presented showing the blowers, dampers, filters, other components 

necessary for operation of the system and flow paths.” The staff noted that SHINE PSAR, 

Section 6a2.2.1, “Confinement,” does not contain or reference the confinement ESF HVAC 

system schematic diagram. Therefore, in RAI 6a2.2-12 (Reference 14), the staff asked the 

applicant to provide the schematic diagram(s) for this system.

In response to RAI 6a2.2-12 (Reference 20), the applicant stated that PSAR Figures 9a2.1-1 

and 9a2.1-2 provide schematic diagrams showing the ESF heating, ventilation, and air 

conditioning (HVAC) systems, including blowers, dampers, filters, other components necessary 

for operation of the system, and flow paths.

The staff finds this response satisfies the acceptance criteria of NUREG-1537, Part 2, 

Section 6.2.1 and demonstrates adequate design criteria for a preliminary design. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

NUREG-1537, Part 1, Section 6.2.1, “Confinement,” states, in part, that “[a]utomatic and manual 

trip circuits, bypasses, interlocks, and special I&C [instrumentation and control] systems for the 

ESF system should be described briefly in this section and in detail in Chapter 7.” 

NUREG-1537, Part 2, Section 6.2.1, “Confinement,” Areas of Review, states, in part, that “[t]he 

reviewer should evaluate... [Thus, this section should contain a]...description of control and 
Engineered Safety Features

6-14

safety instrumentation, including the locations and functions of sensors, readout devices, 

monitors, and isolation components, as applicable.”

SHINE PSAR, Section 6a2.2.1, “Confinement,” discusses the confinement ESF system, but the 

staff did not find a description of the automatic and manual trip circuits, bypasses, interlocks, 

and special I&C systems. Therefore, in RAI 6a2.2-13 (Reference 14), the staff asked the 

applicant to provide a brief description of automatic and manual trip circuits, bypasses, 

interlocks, and special I&C systems, including relevant schematics or functional block diagrams, 

or reference(s) to their location in PSAR Chapter 7.

In response to RAI 6a2.2-13 (Reference 20), the applicant stated, in part, that:

...these confinement boundaries include passive barriers (e.g., walls) and active 

components (e.g., isolation dampers, isolation valves). The active components 

required to function to maintain the confinement barrier in an accident are 

Engineered Safety Features (ESFs) and they are actuated by the Engineered 

Safety Features Actuation System (ESFAS). A description of the ESFAS is 

provided in PSAR Section 7a2.5. No special I&C systems are employed in ESF 

actuation. A discussion of the automatic and manual trip circuits of the ESFAS is 

provided in PSAR Subsection 7a2.5.4. A typical ESF circuit is provided in PSAR 

Figure 7a2.5-1, an example ESFAS panel is provided in PSAR Figure 7a2.5-2, 

and the ESFAS operator control panel is provided in PSAR Figure 7a2.5-3. 

These figures represent the current schematics for the ESFAS. A description of 

the ESFAS interlocks and bypasses, if any, will be determined as a part of 

detailed design and provided in the FSAR. An IMR has been initiated to track the 

inclusion of a description of the ESFAS interlocks and bypasses, if any, in the 

FSAR.

The staff finds this response satisfies the acceptance criteria of NUREG-1537, Part 2, 

Section 6.2.1 and demonstrates adequate design criteria for a preliminary design. It is 

reasonable to leave description of the ESFAS interlocks and bypasses, if included in the final 

design, as part of the detailed design to be provided in the FSAR. The staff will confirm that the 

final design conforms to this design basis during the evaluation of SHINE’s FSAR.

NUREG-1537, Part 1, Section 6.2.1, “Confinement,” states, in part, that “[p]eriodic functional 

testing of damper closure, room isolation, minimum airflow rates, automatic system shutdown 

and startup, and activation setpoints should be required and specified. See Chapter 14, 

“Technical Specifications,” of this format and content guide, for details on what technical 

specification requirements should be identified and justified in this section.”

NUREG-1537, Part 2, Section 6.2.1, “Confinement,” Areas of Review, states, in part, that “[t]he 

reviewer should evaluate...[Thus, this section should describe]... [s]urveillance methods and 

intervals included in the technical specifications that ensure operability and availability of the 

confinement ESFs, when required.”

SHINE PSAR, Section 6a2.2.1.5, “Engineered Safety Feature Test Requirements,” states, in 

part, that “[e]ngineered safety features are periodically tested to ensure that ESF components 

maintain operability....” However, the staff noted that plans for testing ESF functionality as well 

as operability were not fully described. Therefore, in RAI 6a2.2-14a (Reference 14), the staff 

asked the applicant to describe planned tests of ESFs for “functionality” as well as “operability” 
Engineered Safety Features

6-15

(an example would be leak tightness), including preoperational, as well as post-commissioning 

testing.

In response to RAI 6a2.2-14a (Reference 20), the applicant stated:

Of the two terms “operable” and “functional,” “operable” is the more restrictive 

condition, applying only to SSCs described in the TS. A component or system is 

operable when it is capable of performing its intended function. To be operable, 

an SSC must be able to perform its design basis function, and be in compliance 

and in-frequency for the TS surveillances. “Functionality” is generally only 

applied to non-TS SSCs, and is therefore not specifically defined in the same 

manner as “operability,” but usually refers to the ability of non-TS SSCs to 

perform their design functions. ESF SSCs will be tested pre-operationally and 

following receipt of an OL via TS surveillances, to ensure that the assumptions 

made in PSAR Chapter 13 are valid. SHINE’s current planned tests for ESF 

components, both pre-operational and post-commissioning, are as follows:

• Penetration seals, isolation valves, bubble-tight isolation dampers, 

gloveboxes, and other components that are relied upon to maintain the 

confinement boundary will be leak tested;

• Isolation valves, bubble-tight dampers, and other equipment relied upon to 

change position in response to an ESFAS signal will be tested for freedom of 

movement and correct position indication in response to manual and 

automatic ESFAS signals;

• Additional testing will be conducted based on applicable vendor 

recommendations; and

• Intervals of testing will be included in the TS and may be based on factors 

such as manufacturer recommendations, industry operating experience, 

equipment reliability, or plant risk.

The staff finds this response satisfies the acceptance criteria of NUREG-1537, Part 2, 

Section 6.2.1 and demonstrates adequate design criteria for a preliminary design. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

On the basis of its review, the staff has determined that the level of detail provided on 

confinement is adequate and supports the preliminary design and satisfied the applicable 

acceptance criteria of NUREG-1537, Part 2, Section 6.2.1, allowing the staff to conclude:

(1) The scenarios for potential accidents at the facility have been analyzed by the 

applicant and reviewed by the staff. Mitigation of consequences by a confinement 

system has been proposed in the SAR analyses for any accident that could lead to 

potential unacceptable radiological exposures to the public, the facility staff or the 

environment. The preliminary designs and functional descriptions of the confinement 

ESF reasonably ensure that the consequences will be limited to the levels found 

acceptable in the accident analyses of PSAR Chapter 13.

(2) The radiological consequences from accidents to the public, the environment, and the 

facility staff will be reduced by the proposed confinement ESF to values that do not 

exceed the applicable limits of 10 CFR Part 20 and are as far below the regulatory 

limits as can be reasonably achieved.
Engineered Safety Features

6-16

Therefore, the staff finds that the preliminary design of the SHINE confinement ESFs, as 

described in PSAR Section 6a2.2 and supplemented by the applicant’s responses to RAIs, is 

sufficient and meets the applicable regulatory requirements and guidance for the issuance of a 

construction permit in accordance with 10 CFR 50.35 and 50.40. Further technical or design 

information required to complete the safety analysis may reasonably be left for later 

consideration in the FSAR. The staff will confirm that the final design conforms to this design 

basis during evaluation of SHINE’s FSAR.

6a.4.3 Containment

The staff evaluated the sufficiency of SHINE’s treatment of containment, as described in SHINE 

PSAR Section 6a2.2.2, “Containment,” using the guidance and acceptance criteria of Section 

6.2.2, “Containment,” of NUREG-1537, Parts 1 and 2. As stated in SHINE PSAR Section 6a2.2, 

“The SHINE facility does not employ a containment feature. Due to the low temperature and 

power level of facility operations, the safety analysis demonstrates that confinement features 

are adequate to mitigate potential accidents.” 

Based on the information provided on the preliminary design of the SHINE facility and evaluated 

in Section 6a.4.2, above, the staff finds that the SHINE confinement features are adequate to 

mitigate potential accidents and a containment feature is not necessary.

6a.4.4 Emergency Cooling System

The staff evaluated the sufficiency of SHINE’s treatment of emergency cooling systems, as 

described in SHINE PSAR Section 6a2.3, “Emergency Cooling System,” using the guidance 

and acceptance criteria of Section 6.2.3, “Emergency Core Cooling System,” of NUREG-1537, 

Parts 1 and 2. SHINE PSAR Section 6a2.3, with reference to PSAR Chapter 13, states, 

“[d]ecay heat removal during accident scenarios is provided by the safety-related light water 

pool. No emergency core cooling system is required for the SHINE facility to mitigate the 

consequences of an accident.”

Based on the information provided on the preliminary design of the SHINE facility, including the 

information provided in Sections 6a2.3 and 13a of the SHINE PSAR, the staff finds that an 

emergency cooling system is not required to mitigate the consequences of an accident at the 

SHINE facility.

6a.4.5 Probable Subjects of Technical Specifications

In accordance with 10 CFR 50.34(a)(5), the staff evaluated the sufficiency of the applicant’s 

identification and justification for the selection of those variables, conditions, or other items 

which are determined to be probable subjects of technical specifications for the SHINE IF ESFs, 

and gave special attention to those items which may significantly influence the final design. 

NUREG-1537, Part 1, Section 6.2.1, “Confinement,” states, in part, that “[p]eriodic functional 

testing of damper closure, room isolation, minimum airflow rates, automatic system shutdown 

and startup, and activation setpoints should be required and specified. See Chapter 14, 

“Technical Specifications,” of this format and content guide, for details on what technical 

specification requirements should be identified and justified in this section.”

NUREG-1537, Part 2, Section 6.2.1, “Confinement,” Areas of Review, states, in part, that “[t]he 

reviewer should evaluate... [Thus, this section should describe]... [s]urveillance methods and 

intervals included in the technical specifications that ensure operability and availability of the 
Engineered Safety Features

6-17

confinement ESFs, when required.” SHINE PSAR, Section 6a2.2.1.6, “Design Bases,” states, 

in part, that “[p]otential variables, conditions, or other items that will be probable subjects of a 

technical specification associated with the IF confinement systems and components are 

provided in Chapter 14.” The staff noted it needed additional information on the probable 

subjects of technical specifications to determine the adequacy of the IF confinement systems 

and components.

Therefore, in RAI 6a2.2-14b (Reference 14), the staff asked the applicant to provide the 

information on the probable subjects of technical specification requirements, including periodic 

functional testing of damper closure, room isolation, minimum airflow rates, automatic system 

shutdown and startup, and activation setpoints, in the appropriate location(s) in Section 6a2 that 

is specified in NUREG-1537, Part 1, Chapter 14.

In response to RAI 6a2.2-14b (Reference 20), the applicant stated, in part, that the ESF function 

for both the IF and RPF:

. . . consists of confinement systems, ventilation systems, and control systems. 

Post-accident mitigation is accomplished by confinement of radioactive or 

hazardous material to controlled areas to mitigate the consequences of design 

basis accidents (DBAs). This confinement occurs by shutting isolation dampers 

in the ventilation systems or isolation valves in lines penetrating the confinement 

area when parameters are determined to be outside predefined limits. This 

function is known as the ESF function. The control systems that perform this 

function are known as the ESFAS in the IF, and the Radiological Integrated 

Control System (RICS) in the RPF.

Probable subjects of proposed TS for the IF and RPF ESF confinement systems 

are provided in PSAR Table 14a2-1, Section 3.4, and are also referenced for the 

RPF specifically in Subsection PSAR 14b.3.2. Per PSAR Table 14a2-1, the 

following Confinement Limiting Conditions of Operation (LCOs) will be 

developed:

• TPS glove box system or confinement (IF)

• IU and TOGS shielded cell confinement isolation valves (IF)

• Confinement isolation valves (RPF)

Probable subjects of proposed TS for the IF and RPF ESF ventilation systems 

are provided in PSAR Table 14a2-1, Section 3.5, and are also referenced for the 

RPF specifically in PSAR Subsection 14b.3.3. Per PSAR Table 14a2-1, the 

following LCOs will be developed:

• RVZ1 and RVZ2 isolation dampers (IF and RPF)

Probable subjects of proposed TS for ESF control and actuation are provided in 

PSAR Table 14a2-1 Sections 3.2 and 3.9 of, and are also referenced for the RPF 

specifically in PSAR Subsections 14b.3.1 and 14b.3.5. Per PSAR Table 14a2-1, 

the following LCOs will be developed:

• ESFAS input to the TRPS, including the required operable channels per 

future TS Table 3.2.1 (i.e., TS Table 3.2.1 will include channel(s) monitored, 
Engineered Safety Features

6-18

number of channels required, allowable value, nominal setpoint, permissible 

bypass, or other conditions) (IF)

• RICS (initiates the isolation functions necessary to achieve confinement in 

the RPF)

The probable subjects of TS for ESF equipment are described above. Specific 

details related to these probable subjects, such as periodic functional testing of 

damper closure, room isolation, minimum airflow rates, automatic system 

shutdown and startup, and activation setpoints will be provided in the SHINE TS, 

which will be provided as part of the SHINE [operating license] OL Application.

The staff finds this response satisfies the acceptance criteria of NUREG-1537, Part 2, 

Section 6.2.1 and demonstrates adequate design criteria for a preliminary design. 

Additionally, SHINE PSAR Section 6a2.4, “Irradiation Facility Engineered Safety Features 

Technical Specifications,” states, in part, that “potential variables, conditions, or other items that 

will be probable subjects of technical specifications associated with the IF ESFs are provided in 

Chapter 14.”

Based on the information provided in PSAR Chapters 6a and 14, as well as PSAR Table 14a2-1 

and supplemented by the response to RAI 6a2.2-14(b), the staff finds that the identification and 

justification for the selection of those variables, conditions, or other items which are determined 

to be probable subjects of technical specifications for the SHINE IF ESFs are sufficient and 

meet the applicable regulatory requirements and acceptance criteria of NUREG-1537 for the 

issuance of a construction permit in accordance with 10 CFR 50.35. A detailed evaluation of 

technical specifications, including LCOs and surveillance requirements, will be performed during 

the review of the SHINE operating license application.

6a.5 Summary and Conclusions

The staff evaluated the descriptions and discussions of SHINE’s IF ESFs, including probable 

subjects of technical specifications, as described in SHINE PSAR Section 6a2 and 

supplemented by the applicant’s responses to RAIs, and finds that the preliminary design of 

SHINE’s IF ESFs, including the principal design criteria; design bases; and information relative 

to materials of construction, general arrangement, and approximate dimensions: (1) provides 

reasonable assurance that the final design will conform to the design basis, and (2) meets all 

applicable regulatory requirements and acceptance criteria in NUREG-1537. 

On the basis of these findings, the staff has made the following conclusions for the issuance of 

a construction permit in accordance with 10 CFR 50.35 and 50.40:

(1) SHINE has described the proposed design of IF ESF systems, including, but not 

limited to, the principal architectural and engineering criteria for the design, and has 

identified the major features or components incorporated therein for the protection of 

the health and safety of the public.

(2) Further technical or design information required to complete the safety analysis of the 

IF ESFs may reasonably be left for later consideration in the FSAR.
Engineered Safety Features

6-19

(3) There is reasonable assurance that taking into consideration the site criteria contained 

in 10 CFR 100, the proposed facility can be constructed and operated at the proposed 

location without undue risk to the health and safety of the public.

(4) There is reasonable assurance: (i) that the construction of the SHINE facility will not 

endanger the health and safety of the public, and (ii) that construction activities can be 

conducted in compliance with the Commission’s regulations.

(5) The issuance of a permit for the construction of the facility would not be inimical to the 

common defense and security or to the health and safety of the public.

6b Radioisotope Production Facility Engineered Safety Features

SER Section 6b, “Radioisotope Production Facility Engineered Safety Features,” provides an 

evaluation of the preliminary design of SHINE’s RPF ESFs, as presented in SHINE PSAR 

Section 6b, “Radioisotope Production Facility Engineered Safety Features,” within which, SHINE 

describes RPF ESFs and nuclear criticality control.

6b.1 Areas of Review

The staff reviewed SHINE PSAR Section 6b against applicable regulatory requirements using 

appropriate regulatory guidance and standards to assess the sufficiency of the preliminary 

design and performance of SHINE’s RPF ESFs. As part of this review, the staff evaluated 

descriptions and discussions of SHINE’s RPF ESFs, with special attention to design and 

operating characteristics, unusual or novel design features, and principal safety considerations. 

The preliminary design of SHINE’s RPF ESF systems was evaluated to ensure the sufficiency 

of principal design criteria, design bases, and information relative to materials of construction, 

general arrangement, and approximate dimensions, sufficient to provide reasonable assurance

that the final design will conform to the design basis. In addition, the staff reviewed SHINE’s 

identification and justification for the selection of those variables, conditions, or other items 

which are determined to be probable subjects of technical specifications for the facility, with 

special attention given to those items which may significantly influence the final design.

Areas of review for this section included a summary description of the RPF ESFs, as well as a 

description of the RPF confinement and nuclear criticality safety analysis. Within these review 

areas, the staff assessed, in part, confinement system and components, functional requirements 

of confinement, management of the nuclear criticality safety program, planned responses to 

criticality accidents, criticality-safety controls, nuclear criticality safety evaluations, and the 

criticality accident alarm system (CAAS).

6b.2 Summary of Application

In PSAR Section 6b.1, SHINE briefly describes the SSCs that constitute the confinement ESFs

in the RPF design and summarizes the postulated accidents whose consequences could be 

unacceptable without mitigation. As described in greater detail in PSAR Chapter 13b, specific 

postulated accident scenarios indicate the need for the confinement ESFs.

In PSAR Section 6b.2, SHINE described, in detail, the confinement ESF SSCs that will be 

incorporated into the RPF design. The HVAC and air exhaust systems RVZ1 and RVZ2 are 

associated with the confinement and are designed to change configuration or operating mode in 

response to several potential accidents analyzed in Chapter 13b and thereby mitigate its 
Engineered Safety Features

6-20

consequences. They are considered part of the confinement ESF and are discussed in PSAR 

Section 6b.2. The confinement ESF SSCs are passive and active features designed to mitigate 

the consequences of accidents and to keep the radiological and chemical exposures to the 

public, the facility staff, and the environment within acceptable values. PSAR Sections 6b.2 and 

9a2.1 provides the details of design, initiation, and operation of confinement ESF SSCs that are 

provided to mitigate the DBAs discussed in PSAR Section 6b.1. This includes chemical storage 

areas outside the RCA.

In PSAR Section 6b.3, the applicant states that its nuclear criticality safety program (NCSP) for 

the design, construction, and operation of the RPF will be consistent with applicable American 

National Standards Institute/American Nuclear Society (ANSI/ANS) standards as endorsed by 

Regulatory Guide 3.71, “Nuclear Criticality Safety Standards for Fuels and Material Facilities” 

(Reference 75). The standards committed to include ANSI/ANS-8.1-1998, “Nuclear Criticality 

Safety in Operations with Fissionable Materials Outside Reactors,” ANS-8.3-1997, “Criticality 

Accident Alarm System,” ANS-8.7-1998, “Nuclear Criticality Safety in the Storage of Fissile 

Materials,” ANS-8.10-1983, “Criteria for Nuclear Criticality Safety Controls in Operations With 

Shielding and Confinement,” ANS-8.20-1991, “Nuclear Criticality Safety Training,”

ANS-8.21-1995, “Use of Fixed Neutron Absorbers in Nuclear Facilities Outside Reactors,”

ANS-8.23-2007, “Nuclear Criticality Accident Emergency Planning and Response,”

ANS-8.24-2007, “Validation of Neutron Transport Methods for Nuclear Criticality Safety 

Calculations,” and ANS-8.26-2007, “Criticality Safety Engineer Training and Qualification 

Program” (References 62-70).

Commitments related to the design of the facility and its SSCs are described in PSAR Section 

6b.3, to ensure that subcriticality will be maintained with an acceptable margin under normal 

and credible abnormal conditions. These commitments include preference for passive over 

active engineered controls and engineered over administrative controls; adherence to the 

double contingency principle (DCP); and performance of documented and independently 

reviewed NCS evaluations (NCSEs) to identify significant parameters that will be controlled 

within each process. The dominant controlled parameters are geometry and mass, although 

interaction and neutron absorption are also mentioned. The NCSEs will be the basis for SSCs 

and administrative controls relied on to ensure subcriticality. The appropriate margin of 

subcriticality depends, in part, on using a calculational methodology that is validated for use 

within a demonstrated area of applicability (AOA). The staff reviewed the licensee’s 

programmatic commitments for the NCSP against the acceptance criteria in ISG Section 6b.3, 

and determined that it met the guidance applicable to construction. The staff’s review of the 

applicant’s computer code validation report is in Section 6b.4.5 of this SER. 

6b.3 Regulatory Basis and Acceptance Criteria

The staff reviewed SHINE PSAR Section 6b against applicable regulatory requirements, using 

appropriate regulatory guidance and standards, to assess the sufficiency of the preliminary 

design and performance of SHINE’s I&C systems for the issuance of a construction permit. In 

accordance with paragraph (a) of 10 CFR 50.35, “Issuance of Construction Permits,” a 

construction permit authorizing SHINE to proceed with construction may be issued once the 

following findings have been made:

(1) SHINE has described the proposed design of the facility, including, but not limited to, 

the principal architectural and engineering criteria for the design, and has identified the 

major features or components incorporated therein for the protection of the health and 

safety of the public.
Engineered Safety Features

6-21

(2) Such further technical or design information as may be required to complete the safety 

analysis, and which can reasonably be left for later consideration, will be supplied in 

the FSAR.

(3) Safety features or components, if any, which require research and development have 

been described by SHINE and a research and development program will be conducted 

that is reasonably designed to resolve any safety questions associated with such 

features or components.

(4) On the basis of the foregoing, there is reasonable assurance that: (i) such safety 

questions will be satisfactorily resolved at or before the latest date stated in the 

application for completion of construction of the proposed facility, and (ii) taking into 

consideration the site criteria contained in 10 CFR Part 100, the proposed facility can 

be constructed and operated at the proposed location without undue risk to the health 

and safety of the public.

With respect to the last of these findings, the staff notes that the requirements of 

10 CFR Part 100 are specific to nuclear power reactors, and therefore not applicable to the 

SHINE facility. However, the staff evaluated SHINE’s site specific conditions using site criteria 

similar to 10 CFR Part 100, by using the guidance in NUREG--1537. The staff’s review 

evaluated the geography and demography of the site; nearby industrial, transportation, and 

military facilities; site meteorology; site hydrology; and site geology, seismology, and 

geotechnical engineering to ensure that issuance of the construction permit will not be inimical 

to public health and safety.

The staff’s evaluation of the preliminary design of SHINE’s RPF ESFs does not constitute 

approval of the safety of any design feature or specification. Such approval will be made 

following the evaluation of the final design of SHINE’s RPF ESFs as described in the FSAR as 

part of SHINE’s operating license application.

6b.3.1 Applicable Regulatory Requirements

The applicable regulatory requirements for the evaluation of SHINE’s RPF ESFs are as follows:

• 10 CFR 50.34, “Contents of applications; technical information,” paragraph (a), 

“Preliminary safety analysis report.”

• 10 CFR 50.40, “Common Standards.”

• 10 CFR 20.1201, “Occupational dose limits for adults.”

• 10 CFR 20.1301, “Dose limits for individual members of the public.”

In addition to any radiological hazards associated with operations in a production facility, 

10 CFR Part 70, Subpart H, “Additional Requirements for Certain Licensees Authorized to 

Possess a Critical Mass of Special Nuclear Material,” specifies limits regarding exposure to 

hazardous chemicals. Although not a requirement for 10 CFR Part 50 licenses, these limits 

were considered when reviewing this section of the SHINE PSAR.
Engineered Safety Features

6-22

6b.3.2 Regulatory Guidance and Acceptance Criteria

In applying guidance and acceptance criteria, the staff used its judgment as to which 

acceptance criteria were relevant to SHINE’s proposed facility, as much of this guidance was 

originally developed for nuclear reactors. Given the similarities in SHINE’s proposed facility and 

non-power research reactors, the staff used established guidance documents and the 

Commission’s regulations to determine the acceptance criteria for demonstrating compliance 

with 10 CFR regulatory requirements. For example, the staff used: 

• NUREG-1537, Part 1.

• NUREG-1537, Part 2.

• Final ISG Augmenting NUREG-1537, Part 1.

• Final ISG Augmenting NUREG-1537, Part 2.

As stated in the ISG Augmenting NUREG-1537, the staff determined that certain guidance 

originally developed for heterogeneous non-power research and test reactors is applicable to 

aqueous homogenous facilities and production facilities. SHINE used this guidance to inform 

the design of its facility and prepare its PSAR. The staff’s use of reactor-based guidance in its 

evaluation of the SHINE PSAR is consistent with the ISG Augmenting NUREG-1537.

As appropriate, additional guidance (e.g., NRC regulatory guides, IEEE standards, ANSI/ANS 

standards) has been used in the staff’s review of SHINE’s PSAR. The use of additional 

guidance is based on the technical judgment of the reviewer, as well as references in 

NUREG-1537, Parts 1 and 2; the ISG Augmenting NUREG-1537, Parts 1 and 2; and the SHINE 

PSAR. Additional guidance documents used to evaluate SHINE’s PSAR are provided as 

references in Appendix B of this SER.

6b.4 Review Procedures, Technical Evaluation, and Evaluation Findings

The staff performed an evaluation of the technical information presented in SHINE PSAR 

Section 6b, as supplemented by the applicant’s responses to RAIs, to assess the sufficiency of 

the preliminary design and performance of the SHINE RPF ESFs for the issuance of a 

construction permit, in accordance with 10 CFR 50.35(a). Sufficiency of the preliminary design 

and performance of the SHINE RPF ESFs is determined by ensuring the design and 

performance meet applicable regulatory requirements, guidance, and acceptance criteria, as 

discussed in Section 6b.3, “Regulatory Basis and Acceptance Criteria,” of this SER. While the 

technical evaluation of these systems provided in this section is specific to the SHINE RPF, the 

staff’s review considers the interface of these systems between the IF and RPF as part of a 

comprehensive technical evaluation. A summary of the results of the staff’s technical evaluation 

is described in Section 6b.5, “Summary and Conclusion.”

For the purposes of issuing a construction permit, the preliminary design of the SHINE RPF 

ESFs may be adequately described at a functional or conceptual level. The staff evaluated the 

sufficiency of the preliminary design of the SHINE RPF ESFs based on the applicant’s design 

methodology and ability to provide reasonable assurance that the final design will conform to 

the design bases with adequate margin for safety. As such, the staff’s evaluation of the 

preliminary design of the SHINE RPF ESFs does not constitute approval of the safety of any 

design feature or specification. Such approval will be made following the evaluation of the final 

design of the SHINE RPF ESFs, as described in the FSAR, as part of SHINE’s operating 

license application.
Engineered Safety Features

6-23

6b.4.1 Summary Description

The staff evaluated the sufficiency of SHINE’s summary description of its RPF ESFs, as 

described in SHINE PSAR Section 6b.1, “Summary Description,” using the guidance from 

Section 6.1, “Summary Description,” of NUREG-1537, Parts 1 and 2.

In PSAR Section 6b.1, SHINE briefly describes the SSCs that constitute the confinement ESFs 

in the RPF design and summarizes the postulated accidents whose consequences could be 

unacceptable without mitigation. As described in greater detail in PSAR Chapter 13b, specific 

postulated accident scenarios indicate the need for the confinement ESFs. The details of the 

accident analyses are given in PSAR Chapter 13b, and the detailed discussions of the 

confinement ESFs in PSAR Section 6b.2. The confinement ESF summary includes the design 

bases, the performance criteria, and the full range of RPF conditions, including accident 

conditions, under which the confinement ESF SSCs must maintain function. 

According to Chapter 13 of 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’” (Reference 6), the following DBAs are to be addressed for the RPF:

a. Critical equipment malfunction.

b. Inadvertent nuclear criticality in the RPF.

c. RPF fire.

d. Accidents with hazardous chemicals.

e. External events.

These DBAs encompass loss-of-offsite power (LOOP) and operator errors (See SER 

Section 13b).

SHINE states that two of the DBAs – b., and e. above – do not have consequences that require 

mitigation by the confinement ESFs. The remaining two DBAs – a. and d. above – require the 

confinement ESF SSCs to mitigate consequences.

The confinement ESF SSCs provide active and passive protection against the potential release 

of radioactive materials or chemicals to the environment following a design basis accident. The 

confinement ESF SSCs provide for active isolation of piping and HVAC systems penetrating 

confinement boundaries in certain post-accident conditions.

PSAR Section 6b.2 and its subsections describe the confinement ESF and its modes of 

initiation and operation, and describe the SSCs in detail. The confinement ESF consists of the 

following SSCs:

• Hot cells, including penetration seals.

• RCA ventilation system Zone 1 (RVZ1) (including ductwork up to filters and filters) and 

Zone 2 (RVZ2).

• Bubble-tight isolation dampers.

• Tank vaults.

• Radiological integrated controls system (RICS).

• Isolation valves on piping systems penetrating hot cells.
Engineered Safety Features

6-24

PSAR Table 6b.2-2, “Radioisotope Production Facility Confinement Safety Functions,” shows 

the location, basic function, and relationship of the confinement ESF to the facility. The 

summary description contained enough information for an overall understanding of the function 

and relationship of the ESF to the operation of the facility.

On the basis of its review, the staff has determined that the summary description of the SHINE 

RPF ESFs demonstrates an adequate design basis for a preliminary design.

Therefore, the staff finds that the summary description of the SHINE RPF ESFs, as described in 

SHINE PSAR Section 6b.1, is sufficient and meets the applicable regulatory requirements and 

guidance for the issuance of a construction permit in accordance with 10 CFR 50.35. Further 

technical or design information required to complete the safety analysis may reasonably be left 

for later consideration. The staff will confirm that the final design conforms to the described 

design basis during the evaluation of SHINE’s FSAR.

6b.4.2 Confinement

The staff evaluated the sufficiency of the preliminary design of the SHINE confinement and 

related systems as described in SHINE PSAR 6b.2.1, “Confinement,” in part, by reviewing 

confinement mitigation requirements, the defined confinement envelope, and detailed 

descriptions of the ESFs associated with confinement. Additionally, the staff evaluated the 

passive and active ESF components, under normal and upset operational conditions. The 

functional requirements, design bases, probable subjects of technical specifications, and testing 

requirements were also evaluated for sufficiency.

Consistent with the review procedures of NUREG-1537, Part 2, Section 6.2.1, “Confinement,” 

the staff: (1) reviewed the accident scenarios analyzed in PSAR Chapter 13 and evaluated 

whether the confinement will sufficiently mitigate consequences; (2) reviewed design and 

functional bases against analyzed accidents; and, (3) compared diffusion and dispersion of 

released airborne radionuclides. More specifically, the staff evaluated the following elements of 

SHINE’s confinement:

• Design bases and functional description of the required mitigative features of the 

confinement ESF SSCs, derived from the accident scenarios.

• Drawings, schematic diagrams, and tables of important design and operating 

parameters and specifications for the confinement ESF SSCs, including the following:

­ seals, gaskets, filters, and penetrations (e.g., electrical, experimental, air, and 

water)

­ necessary ESF equipment included as part of the confinement

­ fabrication specifications for essential and safety-related components

• Discussion and analyses, keyed to drawings, of how the structure provides the 

necessary confinement analyzed in PSAR Chapter 13, with cross reference to other 

PSAR sections for discussion of normal operations including Section 4b, “Radioisotope 

Production Facility Description,” and Chapter 11, “Radiation Protection and Waste 

Management.”
Engineered Safety Features

6-25

• Discussion of the required limitations on release of confined effluents to the 

environment.

• Surveillance methods and intervals will be included in the FSAR technical specifications 

that ensure operability and availability of the confinement ESF SSCs.

In PSAR Section 6b.2, SHINE described in detail the confinement ESF SSCs that will be 

incorporated into the RPF design. The HVAC and air exhaust systems RVZ1 and RVZ2 are 

associated with the confinement and are designed to change configuration or operating mode in 

response to several potential accidents analyzed in Chapter 13b and thereby mitigate its 

consequences. They are considered part of the confinement ESF and are discussed in PSAR 

Section 6b.2. The confinement ESF SSCs are passive and active features designed to mitigate 

the consequences of accidents and to keep the radiological and chemical exposures to the 

public, the facility staff, and the environment within acceptable values. PSAR Section 6b.2 

provides the details of design, initiation, and operation of confinement ESF SSCs that are 

provided to mitigate the DBAs discussed in PSAR Section 6b.1. This includes chemical storage 

areas outside the RCA.

Confinement in the radioisotope production facility includes the low-leakage boundary 

surrounding radioactive or hazardous chemical materials released during an accident, and parts 

of RVZ1 and RVZ2. The boundary and parts of RVZ1 and RVZ2 localize releases of radioactive 

or hazardous materials to controlled areas and mitigate the consequences of DBAs. Adequate 

shielding and RCA ventilation (RV) minimize the hazards normally associated with radioactive 

or chemical materials. A design objective of confinement is to minimize reliance on 

administrative or complex active engineering controls and provide a confinement system that is 

as simple and fail-safe as reasonably possible.

The RPF confinement areas include hot cell enclosures for process operations and trench and 

vault enclosures for process tanks and piping. Confinement is achieved through RV, RICS, and 

biological shielding provided by the steel and concrete structures comprising the walls, roofs, 

and penetrations of the hot cells. Shielding of the hot cells is discussed in detail in PSAR 

Section 4b.2.

The RV serving the RCA, outside of the IF, includes components whose functions are 

designated as nonsafety-related and safety-related. The ductwork, the isolation dampers, and 

the filter trains of RVZ1 are designated as safety-related. 

The hot cells employ a combination passive-active confinement methodology. During normal 

operation, passive confinement is achieved through the contiguous boundary between the 

hazardous materials and the surrounding environment and is credited with confining the 

hazards generated as a result of DBAs.

This boundary includes the biological shield (created by the physical construction of the cell 

itself) and the extension of that boundary through the RVZ1. The intent of the passive boundary 

is to confine hazardous materials while also preventing the introduction of external energy 

sources that could disturb the hazardous materials from their steady-state condition. The extent 

of this passive confinement boundary extends from the upstream side of the intake high 

efficiency particulate air (HEPA) filter to the final downstream HEPA filter prior to exiting the 

building.
Engineered Safety Features

6-26

In the event of a DBA that results in a release inside the hot cells, radioactive material would be 

confined by the biological shield and physical walls of the cell itself. Each line that connects 

directly to the hot cell atmosphere and penetrates the hot cell is provided with redundant 

isolation valves to prevent releases of gaseous or other airborne radioactive material. 

Confinement isolation valves on piping penetrating the hot cell are located as close as practical 

to the confinement boundary and active isolation valves are designed to take the position that 

provides greater safety upon loss of actuating power.

To mitigate the consequences of an uncontrolled release occurring within a hot cell, as well as 

the off-site consequences of releasing fission products through the ventilation system, the 

confinement barrier utilizes an active component in the form of bubble-tight isolation dampers 

(safety-related) on the inlet and outlet ventilation ports of each hot cell. This ESF effectively 

reduces the amount of ductwork in the confinement volume that needs to remain intact to 

achieve hot cell confinement. These dampers close automatically (fail-closed) upon loss of 

power or receipt of a confinement isolation signal generated by the RICS. Following an initiating 

event, the RICS isolates the hot cells. Additional detail on the RICS is provided in PSAR 

Section 7b.

However, in the discussion of SHINE’s mitigative effects, the staff noted the absence of a 

confinement ESF effectiveness comparison. Therefore, the staff issued RAI 6b.2-6 

(Reference 14) requesting that SHINE provide a mitigative study of the confinement ESF 

effectiveness. This information was necessary for the staff to determine that SHINE had met 

the acceptance criteria of NUREG-1537, Part 2, Section 6.2.1, which states, that “[t]he 

discussion of mitigative effects should contain a comparison of potential radiological exposures 

to the facility staff and the public with and without the ESF.”

In response to RAI 6b.2-6 (Reference 21), SHINE provided a comparative study of the ESFs for 

mitigating RPF DBAs, as presented in Table 6b.2-6-1, “Comparison of Unmitigated and 

Mitigated Radiological Doses for RPF DBAs.” For unmitigated consequences, SHINE only 

credited the bubble-tight isolation dampers, assuming none of the active ESFs are functioning.

Table 6b.2-6-1. Comparison of Unmitigated and Mitigated

Radiological Doses for RPF DBAs

Event

Unmitigated Public Dose (rem) Mitigated Public Dose (rem)

Site Boundary Nearest Resident Site Boundary Nearest Resident

TEDE Thyroid TEDE Thyroid TEDE Thyroid TEDE Thyroid

Release of Inventory

Stored in NGRS Storage

Tanks (RPF MHA)

8.20 × 10-1 --- 1.15 × 10-1 --- 8.20 × 10-2 --- 1.15 × 10-2 ---

Critical Equipment 

Malfunction: Loss 

of Piping or Tank 

Integrity

2.19 × 10-1 1.58 3.06 × 10-2 2.21 × 10-1 2.19 × 10-3 1.58 × 10-2 3.06 × 10-4 2.21 × 10-3

 Critical Equipment

 Malfunction: Inadvertent

 Release from NGRS 8.17 × 10-1 --- 1.14 × 10-1 --- 8.17 × 10-2 --- 1.14 × 10-2 ---

RPF Fire 8.77 × 10-3 1.60 × 10-1 1.23 × 10-3 2.24 × 10-2 8.77 × 10-4 1.60 × 10-2 1.23 × 10-4 2.24 × 10-3
Engineered Safety Features

6-27

The staff finds this response satisfies the acceptance criteria of NUREG-1537, Part 2, 

Section 6.2.1 and demonstrates adequate design criteria for a preliminary design. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

Overall performance assurance of the active confinement components at the SHINE facility is 

achieved through factory testing and in-place testing. Duct and housing leak tests will be 

performed consistent with ASME N511, “Standard for In-Service Testing of Nuclear Air 

Treatment, Heating, Ventilating, and Air Conditioning Systems” (Reference 73), with minimum 

acceptance criteria as specified in ASME AG-1-2009, “Code on Nuclear Air and Gas 

Treatment.”

Active confinement components are designed to fail into a safe state if conditions such as loss 

of signal, loss of power, or adverse environments are experienced. Mechanical, 

instrumentation, and electrical systems and components required to perform their intended 

safety function in the event of a single failure, are designed to include sufficient redundancy and 

independence such that a single failure of any active component does not result in a loss of the 

capability of the system to perform its safety functions.

Mechanical, instrumentation, and electrical systems and components are designed to ensure 

that a single failure, in conjunction with an initiating event, does not result in the loss of the 

system’s ability to perform its intended safety function. The single failure considered is a 

random failure and any consequential failures in addition to the initiating event for which the 

system is required and any failures that are a direct or consequential result of the initiating 

event.

The design of safety-related systems (including protection systems) is consistent with IEEE 

Standard 379-2000, “IEEE Standard Application of the Single-Failure Criterion to Nuclear Power 

Generating Station Safety Systems” (Reference 71), and NRC Regulatory Guide 1.53, Revision 

2, “Application of the Single-Failure Criterion to Nuclear Power Plant Protection Systems” 

(Reference 72), in the application of the single-failure criterion.

The following components are associated with the confinement barriers of the hot cells, tank 

vaults and pipe trenches, as described in PSAR Section 6b. Their specific materials, 

construction, and installation and operating requirements are evaluated based on the safety 

analysis. 

Bubble-tight isolation dampers, designed, constructed and tested consistent with

ASME AG-1-2009, Section DA, “Dampers and Louvers”:

• Maintain their functional integrity.

• Maintain their rated leak-tightness following a seismic event.

• Maintain their structural integrity under fan shut-off pressure.

• Provide bubble-tight isolation upon receipt of a control signal or, in the event of loss of 

actuator power, by closure of actuator.
Engineered Safety Features

6-28

• Provide bubble-tight isolation when using manual actuator or when locked closed with 

power actuator removed.

• Relay damper full-open and full-closed position for control and indication by the use of 

limit switches.

Dampers will be butterfly type, blade and frame fabricated of heavy-gage stainless steel. Total 

leakage is based on bubble solution test as outlined in ASME AG-1-2009, Section DA-5141.

Ventilation ductwork and ductwork support materials will meet the requirements of 

ASME AG-1-2009, Article SA-3000, “Materials.” Supports are designed and fabricated 

consistent with the requirements of ASME AG-1-2009, Section SA, “Ductwork.”

Low leakage seals will be provided on each penetration through the hot cells. For systems 

open to the hot cell atmosphere, redundant isolation valves will be provided.

The ESFs will be tested to ensure that ESF components will maintain operability and can 

provide adequate confidence that the system will perform satisfactorily in service during 

postulated events. In reviewing SHINE’s ESF testing, the staff determined that additional 

information was needed in order to satisfy the criteria of NUREG-1537, Part 1, Section 6.2.1, 

which states, in part, that “[p]eriodic functional testing of damper closure, room isolation, 

minimum airflow rates, automatic system shutdown and startup, and activation setpoints should 

be required and specified.” Therefore, in RAI 6b.2-11 (Reference 14), the staff requested, in 

part, that SHINE describe preoperational and post-commissioning testing for ESF components.

In response to this RAI (Reference 20), SHINE provided the following list of planned 

preoperational and post-commissioning tests for ESF components:

• Penetration seals, isolation valves, bubble-tight isolation dampers, gloveboxes, and 

other components that are relied upon to maintain the confinement boundary will be leak 

tested.

• Isolation valves, bubble-tight dampers, and other equipment relied upon to change 

position in response to an ESFAS signal will be tested for freedom of movement and 

correct position indication in response to manual and automatic ESFAS signals.

• Additional testing will be conducted based on applicable vendor recommendations.

• Intervals of testing will be included in the TS and may be based on factors such as 

manufacturer recommendations, industry operating experience, equipment reliability, or 

plant risk.

The staff finds this response satisfies the acceptance criteria of NUREG-1537, Part 2, 

Section 6.2.1 and demonstrates adequate design basis for a preliminary design. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

To the extent possible, the RICS and the confinement ESF whose operation it initiates, will be 

designed to permit testing during plant operation. Testing actuation devices and actuated 

equipment may be done individually or in groups to avoid negative impact to plant operations.
Engineered Safety Features

6-29

The design basis of the RVZ1 and RVZ2 are discussed in PSAR Section 9a2.1.1. The design 

basis of the hot cells is discussed in PSAR Section 4b.2. The ESF-related design basis of the 

RICS is discussed in PSAR Section 7b.4.1.

NRC staff determined that the need for the specified confinement ESF has been properly 

identified. The confinement ESF will not interfere with normal operations or safe RPF 

shutdown. The confinement ESF design features ensure that the system is available and 

operable when it is required for mitigating accident consequences. The minimum design goal of 

the confinement ESFs is to reduce below regulatory limits the potential radiological and 

chemical exposures to the facility staff and members of the public for the accidents discussed at 

the beginning of this chapter for the radioisotope production facility. The design of the 

confinement does not transfer radiological risk to the health and safety of the public in order to 

reduce potential exposures to the facility staff. 

PSAR Section 6b shows that the confinement ESF reduces predicted radiological exposures 

and releases from applicable potential accidents to acceptable levels. The staff examined all 

accident scenarios analyzed in PSAR Section 13b that could lead to significant radiological or 

chemical exposures or releases and verified that consequences can be sufficiently mitigated by 

the confinement ESF. The staff confirmed that the design and functional bases of the 

confinement ESF are derived from the accidents analyzed. The staff compared the dispersion 

and diffusion of released airborne radionuclides discussed in PSAR Chapters 6 and 13, with 

methods described in PSAR Chapter 11, as applicable.

The staff determined that PSAR Section 13b contains sufficient information to conclude that 

scenarios for all potential accidents at the radioisotope production facility, with consequences 

greater than the design bases, have been analyzed by the applicant. Mitigation of 

consequences by a confinement system has been proposed in the PSAR analyses for any 

accident that could lead to potential unacceptable radiological or chemical exposures to the 

public, the facility staff, or the environment. The staff reviewed the designs and functional 

descriptions of the confinement ESF; the designs and functional descriptions reasonably ensure 

that accident consequences will be limited to the levels found acceptable in the accident 

analyses of PSAR Section 13b. The staff concluded that the designs and functional 

descriptions of the confinement ESF reasonably ensure that control of radiological and chemical 

exposures or releases during normal operation will not be degraded by the ESF. The staff 

determined that the radiological consequences from accidents to the public, the environment, 

and the facility staff will be reduced by the confinement ESF to values that do not exceed the 

applicable limits of 10 CFR Part 20 and the chemical exposure criteria specified in PSAR 

Section 3.5b.

On the basis of its review, the staff has determined that the level of detail provided on 

confinement is adequate and supports the preliminary design and satisfied the applicable 

acceptance criteria of NUREG-1537, Part 2, Section 6.2.1, allowing the staff to make the 

following relevant findings: 

(1) The scenarios for potential accidents at the facility have been analyzed by the 

applicant and reviewed by the staff. Mitigation of consequences by a confinement 

system has been proposed in the SAR analyses for any accident that could lead to 

potential unacceptable radiological exposures to the public, the facility staff, or the 

environment. The preliminary designs and functional descriptions of the confinement 

ESF reasonably ensure that the consequences will be limited to the levels found 

acceptable in the accident analyses of PSAR Chapter 13.
Engineered Safety Features

6-30

(2) The radiological consequences from accidents to the public, the environment, and the 

facility staff will be reduced by the proposed confinement ESF to values that do not 

exceed the applicable limits of 10 CFR Part 20 and are as far below the regulatory 

limits as can be reasonably achieved.

Therefore, the staff finds that the preliminary design of the SHINE confinement ESFs, as 

described in PSAR Section 6b.2.1 and supplemented by the applicant’s responses to RAIs, is 

sufficient and meets the applicable regulatory requirements and guidance for the issuance of a 

construction permit in accordance with 10 CFR 50.35 and 50.34. Further technical or design 

information required to complete the safety analysis may reasonably be left for later 

consideration in the FSAR. The staff will confirm that the final design conforms to this design 

basis during evaluation of SHINE’s FSAR.

6b.4.3 Containment

The staff evaluated the sufficiency of SHINE’s treatment of containment, as described in SHINE 

PSAR Section 6b.2.2, “Containment,” using the guidance and acceptance criteria of Section 

6.2.2, “Containment,” of NUREG-1537, Parts 1 and 2. SHINE PSAR Section 6b.2.2 states that 

the SHINE RPF does not employ a containment feature. Due to the low temperature and power 

level of facility operations, the safety analysis demonstrates that confinement features are 

adequate to mitigate potential accidents. PSAR Section 6b.2.1 is provided to describe the use 

of confinements as an ESF for the RPF. 

On the basis of its review, the staff determined that, because SHINE provides a confinement 

ESF to keep the potential risk to the public from accidents at the RPF low, containment is not 

required for normal operation or accident mitigation. The safety analyses in PSAR Section 13b 

show that confinement provides sufficient mitigation for accidents and containment is not 

necessary.

6b.4.4 Emergency Cooling System

The staff evaluated the sufficiency of SHINE’s treatment emergency cooling systems, as 

described in SHINE PSAR Section 6b.2.3, “Emergency Cooling System,” using the guidance 

and acceptance criteria of Section 6.2.3, “Emergency Core Cooling System.” As stated in 

SHINE PSAR Section 6b.2.3, “[t]here is no emergency cooling system associated with the RPF 

side of the SHINE facility[.]”

Based on a review of the accident analysis provided in SHINE PSAR Section 13b, the staff finds 

that there are no accidents requiring emergency cooling, and therefore, an emergency cooling 

system is not required to mitigate the consequences of an accident in the RPF.

6b.4.5 Nuclear Criticality Safety

The staff evaluated the sufficiency of SHINE’s nuclear criticality safety design criteria and 

methods, as described in SHINE PSAR Section 6b.3, “Nuclear Criticality Safety,” and 

supplemented by the applicant’s responses to RAIs, and the applicant’s Nuclear Criticality 

Safety (NCS) Manual, computer code validation report, and a sampling of preliminary NCS 

calculations and evaluations using the guidance and acceptance criteria from Section 6b.3 of 

the ISG Augmenting NUREG-1537, Part 2, which is based on Chapter 5, “Nuclear Criticality 

Safety,” of NUREG-1520 (Reference 60). Specifically, the pertinent sections of Section 6b.3 of 
Engineered Safety Features

6-31

the ISG Augmenting NUREG-1537, Part 2, are drawn from Section 5.4.3, “Regulatory 

Acceptance Criteria,” of NUREG-1520, Rev. 1. 

Consistent with the review procedures of the ISG Augmenting NUREG-1537, Part 2, 

Section 6b.3, “Nuclear Criticality Safety,” the staff reviewed the applicant’s NCS program, 

including organization and administration, management measures, and technical practices, as 

well as the preliminary criticality safety evaluations. For the purposes of issuing a construction 

permit, the staff determined that it was not necessary for SHINE’s Nuclear Criticality Safety 

Program (NCSP) to meet all of the acceptance criteria provided in Section 6b.3 of the ISG 

Augmenting NUREG-1537, Part 2. The staff’s review of SHINE PSAR Section 6b.3 evaluated 

adequacy of pertinent commitments to the design of processes within the SHINE RPF.

Since the design and analyses of the SHINE facility are in preliminary stages, the scope of the 

staff’s evaluation focused on the NCS design criteria and methods that will be utilized to perform 

NCS analyses and design the facility in a manner to maintain subcriticality of fissile material 

processes outside of the irradiation facility. This section of the SER pertains to the analysis and 

design methodologies used to ensure the RPF will remain subcritical under normal and credible 

abnormal conditions by an acceptable margin. While the staff’s review concluded that the 

applicant may proceed with construction, additional information is required to confirm the 

adequacy of the design. Therefore, the staff recommends the inclusion of conditions, described 

below and listed in Appendix A of this SER, in the SHINE construction permit in order for the 

staff to confirm the adequacy of the identified safety features and components of the SHINE 

facility. All conditions of the construction permit must be satisfied prior to the installation of 

certain components and before the completion of construction. Any such further technical or 

design information outside of the scope of these construction permit conditions and as may be 

required to complete the safety analysis of the SHINE facility can reasonably left for later 

consideration during the evaluation of SHINE’s FSAR, as part of the review of an operating 

license application.

During the course of reviewing SHINE’s nuclear criticality safety-program, the staff needed

additional information to evaluate the adequacy of SHINE’s principal design criteria and design 

bases, in accordance with the requirements of 10 CFR 50.34(a)(4). Therefore, in RAIs 6b.3-1 

through 34 (References 14, 16, and 18), the staff requested that the applicant provide 

information to satisfy the acceptance criteria of the ISG Augmenting NUREG-1537, Part 2, 

Section 6b.3. As discussed below, these RAIs covered topics such as SHINE’s treatment of 

controlled parameters, application of the double-contingency principal, and ability to 

demonstrate that, under normal and abnormal credible conditions, all nuclear processes remain 

subcritical.

The applicant commits to including in its design a Criticality Accident Alarm System (CAAS) 

beginning on page 6b-19 of the PSAR. The applicant stated that the CAAS will be consistent 

with ANSI/ANS-8.3-1997 as modified by Regulatory Guide 3.71 (Reference 75). The applicant 

stated the CAAS will be appropriate for the facility for the type of radiation detected, the 

intervening shielding, and the magnitude of the minimum accident of concern, and that the 

CAAS will be designed to remain operational during design basis accidents. The applicant 

further stated that emergency power will be provided to the CAAS via an uninterruptible power 

supply. While the staff determined that these commitments met the necessary acceptance 

criteria to allow SHINE to proceed with construction, additional information is needed to confirm 

the adequacy of the design of the CAAS, including the methods for determining detector 

placement, consistent with the guidance in the ISG Augmenting NUREG-1537 and in 

accordance with the requirements of 10 CFR 70.24, prior to the completion of construction. 
Engineered Safety Features

6-32

Specifically, the design must provide reasonable assurance that the CAAS will have the 

capability of detecting the minimum accident of concern given the shielding designed into the 

facility. 

Therefore, the staff recommends that the construction permit include a condition that 

requires, prior to the completion of construction, SHINE submit periodic reports to the 

NRC, at intervals not to exceed 6 months from the date of the construction permit. As 

described in the proposed permit conditions in Appendix A of this SER, these reports 

shall provide the technical basis for the design of the CAAS, including a description of 

the methodology for determining detector placement.

The applicant committed to establishing an NCSP meeting the requirements of 

ANSI/ANS-8.1-1998 (Reference 62), and ANSI/ANS-8.19-2005 (Reference 76), as well as the 

other standards listed in SHINE PSAR Section 6.b.3. To ensure subcriticality, the applicant 

committed to perform a validation of its calculational method consistent with the acceptance 

criteria listed in the ISG, as discussed in detail below. Using those methods, the applicant 

stated that it would establish Safety Limits (SLs) for processes in the RPF to meet the DCP with 

a conservative margin. Limiting Safety System Settings (LSSSs) will be calculated to provide 

conservative margin below the SL to account for measurement uncertainty, operating 

characteristics of control systems, and accuracy of control instruments, for each parameter for 

which an SL is specified and for which monitoring instruments are used. In addition to LSSSs, 

the applicant will also establish Limiting Conditions for Operations (LCOs) to ensure operations 

are maintained within safe limits. Further evaluation of SHINE’s probable subjects of technical 

specifications is provided in Section 6b.4.6, “Probable Subjects of Technical Specifications.”

On PSAR page 1-4, the applicant states that the RPF is maintained with keff ≤ 0.95. Beginning 

on page 6b-17, the applicant discusses proposed equipment and how SHINE will maintain the 

process equipment in a subcritical state, based on MCNP analyses. In response to RAI 6b.3-1 

(Reference 21), the applicant stated, in part, that it used MCNP to determine preliminary 

criticality safety limits and does not currently plan to use other methods for determination of 

criticality safety limits. Staff finds that the commitments to using either ANSI/ANS standards 

endorsed in RG-3.71 or performing specific analyses using the widely accepted MCNP code to 

be consistent with NRC guidance and industry practice and therefore acceptable. 

In addition to the SLs, LSSSs, and LCOs discussed on pages 14b-2 and 14b-3 of the PSAR, in 

its response to RAI 6b.3-2 (Reference 21), the applicant stated that administrative controls will 

be established to ensure that engineered controls and control systems will be designed, 

implemented, and maintained to ensure they are available and reliable to perform their function 

when needed. Management measures identified through the accident analysis process, 

including safety and operating limits, will be included in the Administrative Controls section of 

the SHINE Technical Specifications (TS) or described in the FSAR and implemented through 

SHINE procedures. These administrative controls will ensure that safety-related SSCs are 

available and reliable to perform their functions when needed. Management measures are 

administrative in nature and may be finalized subsequent to the completion of construction.

The SHINE quality assurance program is described in the SHINE QAPD. This program is 

intended to ensure the long-term reliability and availability of engineered controls through robust 

design control, verification, change control, and procurement. The SHINE configuration 

management program is intended to ensure the design and licensing basis requirements of 

plant SSCs are properly reflected in plant documents such as drawings, calculations, equipment 

specifications, procedures, and software, and that these documents properly reflect the physical 
Engineered Safety Features

6-33

plant SSC configuration. SSCs identified as engineered NCS safety controls (geometry, 

absorbers, etc.) will be designated as safety-related. In response to RAI 6b.3-7 (Reference 21), 

the applicant stated that the SHINE configuration management program is intended to ensure 

that criticality safety controls defined in the NCSEs will not be changed without appropriate 

review by a qualified criticality safety engineer. Procedures will be developed and put in place 

prior to operation so that personnel will not change NCS controls without proper NCS review.

The change management program will include incorporating NCS controls into operating 

procedures and equipment drawings and identifying them as such to ensure they are not 

changed or removed without proper NCS review. Prior to implementing a change, an evaluation 

must conclude that the entire process will remain subcritical, with an approved margin for safety, 

under normal and credible accident conditions. Changes to NCS controls will be documented in 

the appropriate NCSE. In response to RAI 6b.3-2 (Reference 21), the applicant stated that 

procedures will be developed and put in place prior to operation so that personnel will not 

change NCS controls without proper NCS review by a qualified person. The applicant stated 

that changes that involve or could affect SNM will be evaluated under 10 CFR 50.59. This 

program will permit changes to the facility or procedures as described in the FSAR and the 

conduct of tests or experiments not described in the FSAR if prior NRC approval pursuant to 

10 CFR 50.90 is not required. Such changes include new or modified SSCs, computer 

programs, processes, operating procedures, and administrative controls. In Table 6b.3-2, the 

applicant identifies configuration control and change management as required NCS program 

elements. The above process for NCS change management is consistent with the endorsed 

standard ANSI/ANS-8.19-1996 (Reference76), and is therefore acceptable to the staff.

Staff finds the applicant’s commitments to using the NCS program to establish and maintain 

NCS safety and operating limits, including verification and configuration management to be 

adequate. The applicant committed to administrative controls (management measures) to 

ensure that NCS controls are designed, implemented and maintained to ensure they are 

available and reliable. These commitments meet the guidance in the ISG, and the staff 

therefore finds them acceptable. The staff will verify SHINE’s fulfillment of these conditions in 

the FSAR.

Because the SHINE facility will be licensed under 10 CFR Part 50, the performance 

requirements in 10 CFR 70.61 do not explicitly apply. However, as described in Section 6b of 

the ISG Augmenting NUREG-1537, the NRC staff determined that the performance 

requirements of 10 CFR 70.61 can be used to demonstrate adequate safety for an RPF. These 

requirements ensure subcriticality under normal and credible abnormal conditions and are 

drawn from ANSI/ANS-8.1-1998. Therefore, the staff concluded that there is a need to define 

what is considered a credible criticality scenario and, consistent with risk-informed regulation, 

define acceptable risk to the public for credible scenarios. Page 1-4 of the PSAR states, in part, 

that safety-related SSCs “will assure...that the potential for an inadvertent criticality is not 

credible.” This was clarified in the applicant’s response to RAI 6b.3-25 (Reference 25) to mean 

that SSC’s will be utilized to ensure credible criticality sequences will be “highly unlikely.” In the 

response to RAI 13b.1-1, the applicant established, in Table 13b.1-1-2, “Likelihood Index Limit 

Guidelines”, an event frequency associated with highly unlikely consistent with the values found 

in NUREG-1520 (Reference 60). In response to RAIs 6b.3-3 and 6b.3-25, the applicant 

provided the basis for considering a criticality sequence to be “not credible” consistent with the 

three criteria found on page 3-27 of NUREG-1520, Revision 1. Therefore, the staff finds the 

applicant’s definition of the terms “not credible, unlikely, and highly unlikely” to be acceptable. 
Engineered Safety Features

6-34

While the staff finds SHINE’s method of determination of “not credible” criticality sequences is 

sufficient to proceed with construction, additional information is necessary to confirm the 

adequacy of SHINE’s analysis of criticality sequences prior to the completion of construction. 

Specifically, SHINE’s analysis needs to provide the technical justification for its designations of 

“not credible” criticality sequences (e.g., accumulations of uranium in the process ventilation 

system and intermixing of neutron driver deuterium in SNM processes), such that all relevant 

process hazards have been adequately considered. 

Therefore, the staff recommends that prior to the completion of construction, SHINE 

shall submit periodic reports to the NRC, at intervals not to exceed 6 months from the 

date of the construction permit. As described in the proposed permit conditions in 

Appendix A of this SER, these reports shall provide the basis for determining that 

criticality events are “not credible” for RPF processes even though fissile materials may 

be present.

 

The ISG for NUREG-1537, Part 2, includes acceptance criteria for technical practices to ensure 

that sufficient NCS controls developed in NCSEs are identified for each process. The staff 

considers the technical practices for each controlled parameter and associated design criteria, 

including the preferred hierarchy of controls, to be part of the design basis of the proposed 

facility. 

 

On page 1-4 of the PSAR, the applicant commits that, for operations in the RPF, the facility is 

designed to meet the requirements of ANSI/ANS-8.1-1998 (Reference 62), including adherence 

to the double contingency principle. The double contingency principle states “process design 

should incorporate sufficient factors of safety to require at least two unlikely, independent, and 

concurrent changes in process conditions before a criticality accident is possible.” The 

applicant stated that each process that has criticality accident sequences meets the double 

contingency principle. In response to RAI 6b.3-13 (Reference 21), the applicant stated that 

there are currently no planned exceptions to compliance with the double contingency principle. 

In its response to RAI 6.3-14 (Reference 21), the applicant stated that when a single NCS 

control is capable of controlling two or more criticality controlled parameters, another control will 

be identified to provide double contingency protection.

In response to RAI 6b.3-10 (Reference 21), the applicant revised its discussion that tank 

1-TSPS-01T met double contingency through geometry and concentration after the staff had 

determined that concentration was not an independent control for the tank. The applicant also 

stated that double contingency is met by geometry and the configuration management program. 

However, configuration management is not an independent control as it simply ensures the 

availability of the geometry control. In response to RAIs 6b.3-24 and 6b.3-30 (Reference 25 

and Reference 29), the applicant clarified that double contingency will be satisfied by the tank 

geometry and the criticality safe sump/drain system should the tank sustain a leak. Acceptable 

logic for double contingency was also noted in the other accident sequences in the NCSE 

provided in response to RAI 6b.3-30.

Based on SHINE’s responses to these RAIs, the staff finds that the applicant’s commitments to 

the double contingency principle are adequate, but that verification of its proper implementation 

should be addressed consistent with the proposed construction permit conditions as the design 

is finalized. 

The applicant committed to ANSI/ANS-8.1-1998 (Reference 62), which requires that processes 

be shown to be subcritical under normal and credible abnormal conditions. Obtaining 
Engineered Safety Features

6-35

reasonable assurance that processes will be subcritical requires that calculational methods be

validated against experimental data and an acceptable margin of subcriticality provided. 

Ensuring subcriticality with an acceptable margin is part of the design basis for the RPF. 

Determining the bias, uncertainty in the bias, and an administrative margin are all necessary 

tasks in setting a USL that ensures an adequate margin of subcriticality. For the purpose of 

demonstrating subcriticality, the calculated keff must satisfy keff + 2σ ≤ USL, where σ is the 

calculated standard deviation. On page 6b-11 of the PSAR, the applicant stated that the facility 

will be designed to meet ANSI/ANS-8.24-2007 (Reference 69). The applicant proposed use of 

an administrative margin of subcriticality (MoS) for the RPF of 0.05. The stated basis for this 

choice of MoS was the ISG for NUREG-1537, Part 2.

Staff reviewed the validation report submitted in response to RAIs 6b.3-23 (Reference 25 and 

28) to confirm that the USL determination will adequately address the materials and 

enrichments that are of concern for criticality safety as well as any bias and uncertainty present 

in the modeling. The applicant modeled 140 criticality benchmark experiments using MCNP 6.1 

and the ENDF/B-VII.1 continuous energy group cross section library. The modeling was 

performed on the Atkins’ Linux computer cluster. The software and hardware are managed with 

the Atkins NS System’s configuration control. The results of the modeled experiments were 

compiled and analyzed consistent with methods outlined in NUREG/CR-6698, “Guide for 

Validation of Nuclear Criticality Safety Calculational Methodology” (Reference 77). Using this 

guidance, the staff verified the applicant’s correct application of statistical methodology.

In addition, the staff noted that the experiments selected for the validation had limited data for 

the specific enrichment used in the calculations (21wt% 235U) and for one particular material 

type (uranyl sulfate). With regard to sulfur, staff used the TSUNAMI sensitivity/uncertainty 

module in the SCALE-6.1 code package to determine the sensitivity of keff to sulfur cross section 

uncertainties as a function of enrichment in various benchmarks included in the validation 

report. Staff determined that sulfur has, at most, a minor effect on system reactivity and has a 

very low integral sensitivity coefficient as compared to other nuclides in the benchmarks. A 

similar evaluation was done for boron, which was included in the area of applicability (AOA) 

definition table but appeared to be underrepresented in the benchmark experiments, with similar 

results. In both cases, staff determined that uranium sulfate and boron were adequately 

represented in the experiments chosen for benchmarks.

The applicant evaluated its selected 140 benchmarked experiments in three separate data sets: 

intermediate enriched uranium (14.7 to 36 wt% 235U), low to intermediate enriched uranium 

(10 to 36 wt% 235U), and low to high enriched uranium (10 to 94 wt% 235U). The applicant noted 

that only 4 of 54 experiments in the intermediate enriched uranium data set were less than 

30 wt% 235U and, as such, the combined 84 low and intermediate enriched experiments were 

considered to more accurately bound the SHINE enrichment and materials. The combined data 

set evaluated all 140 benchmark experiments together. When evaluating the data, the applicant 

set positive biases to zero in calculating the USL, consistent with the guidance in 

NUREG/CR-6698.

The applicant initially included four experiments from the IEU-SOL-THERM-001 data set in its 

validation benchmark suite. Whereas most of the benchmarks analyzed had either a small 

positive bias (overestimating the experimental keff) or at worst a very slight negative bias 

(underestimating the experimental keff), the 4 benchmarks from the IEU-SOL-THERM-001 

benchmark set had a negative bias of up 2.9 percent in keff. The applicant subsequently 

considered the benchmark set to be unreliable and dropped the 4 benchmarks from its 

validation as being outliers. Staff noted that the applicant committed to the validation 
Engineered Safety Features

6-36

methodology in ANSI/ANS-8.24-2007 (Reference 69), to which the NRC took two exceptions in 

Regulatory Guide 3.71 (Reference 75). With regard to dismissal of outliers, Regulatory Guide 

3.71 states, in part, that “rejection of outliers should be based only on the inconsistency of the 

data with known physical behavior, rather than on statistical methods ... The rejection of outliers, 

without a physical basis for doing so, may lead to a failure to consider all available information 

on possible contributions to the bias.” Although questions had been raised concerning the 

benchmark evaluation for this data set (International Handbook of Evaluated Criticality Safety 

Benchmark Experiments (IHECSBE)), the reason for the observed negative bias was not 

confirmed. In response to RAI 6b.3-34 (Reference 101), the applicant initially indicated there 

was a likely discrepancy in the specification of the critical volume in the benchmark evaluation 

that could explain the calculated negative bias. The applicant stated that it had been in contact 

with the International Criticality Safety Benchmark Evaluation Project (ICSBEP) staff and stated 

that the ICSBEP staff was not currently recommending IEU-SOL-THERM-001 for use in 

validation pending more detailed investigation of the apparent error. However, the applicant 

subsequently revised its response to RAI 6b.3-34, and clarified that the discrepancy appeared 

to be in the benchmark model used, and not in the experiment. Therefore, consistent with the 

above criteria in Regulatory Guide 3.71, the four IEU-SOL-THERM-001 experiments are no 

longer considered outliers and will be included in a future revision to the validation because they 

reflect materials most similar to those used at the SHINE facility. Pending revision of the 

validation report to include the four experiments, SHINE committed to increase its minimum 

margin of subcriticality to 0.06 to bound any possible reduction in the USL resulting from the 

inclusion of these experiments. The staff’s independent analysis using the USLSTATS module 

from the SCALE computer code indicated the inclusion of the four benchmarks, as originally 

modeled, reduced the overall USL by approximately 0.8 percent. Therefore, the 

additional 1 percent subcritical margin would be sufficient to bound the effect once the four 

benchmarks are reevaluated, and SHINE’s response to the RAI is therefore acceptable.

The USL determination for each data set is shown in Table 5 of the current validation report 

(Atkins-NS-DAC-SHN-15-03, Rev. 1) without the four IEU-SOL-THERM-001 benchmarks 

included, and is repeated below:

Table 6b-1. Summary of USL Determination

Enrichment Bias

Bias 

Uncertainty USL

Intermediate 0.0025 0.0109 0.9391

Low to Intermediate 0.0020 0.0078 0.9422

Low, Intermediate, High 0.0011 0.0091 0.9409

The applicant established the USL for RPF operations as the USL for the intermediate 

enrichment data set. The applicant considered this to be a conservative choice, since that was 

the lowest USL for all the data sets considered. The staff considers this the most appropriate 

choice because it is the intermediate enrichment range that most closely corresponds to the 

proposed SHINE activities. The applicant then established the area of applicability (AOA) of the 

benchmarks in Table 9 of the validation report (recreated below in Table 6b-2) using the full 

data set of 140 benchmark experiments, with the exception that it limited the enrichment range 

to that of the intermediate enrichment cases. The staff performed additional analysis using the 

TSUNAMI code to determine the sensitivity of the benchmark correlation to variations in the 

enrichment. Based on its analysis, the staff determined that benchmarks across the entire 

combined enrichment range would be applicable for validation. In addition, the staff compared 

the AOAs determined using each of the three data sets and determined that there were no 
Engineered Safety Features

6-37

significant differences when only the intermediate enrichment data was included. Therefore, the 

staff finds the applicant’s methods for determination of the USL and AOA acceptable.

Staff noted that Section 6b.3 of the PSAR did not include the technical practices for each 

controlled parameter as described on pages 72 – 74 of the ISG for NUREG-1537, Part 2. The 

technical practices, which describe requirements for the use of each controlled parameter (both 

in establishing controls for the parameter and for modeling it in criticality analysis), are part of 

the principal design criteria for the RFP. The margin provided by conservatively modeling 

controlled parameters is part of the overall margin of subcriticality that gives reasonable 

assurance that all processes will be subcritical under normal and credible abnormal conditions. 

Initially, the details of how NCSEs will handle the controlled parameters were not included in the 

PSAR, and not included in the NCS Manual submitted in response to RAI 6b.3-30 

(Reference 29) The applicant did submit some representative analysis (discussed below) that 

illustrated how the parameters were dealt with in specific cases, but these were not reviewed in 

detail. Therefore, additional information was requested, and in response to RAI 6b.3-31 

(Reference 101), the applicant subsequently committed to meet the acceptance criteria for the 

use of each parameter in the ISG, and thus adequately responded to the staff’s requests for 

additional information on this subject.

Table 6b-2. Area of Applicability Summary

Parameter Area of Applicability

Fissile Material UO2, UH3, Metal, UO2(NO3)2, UF4, U-ZrH, UO2F2, UxOy, 

UO2SO4

Fissile Material Form Solid and Solution

H/235U ratio 0 ≤ H/235U ≤ 1400

Average Neutron Energy 

Causing Fission (MeV) 0.0027 ˂ ANECF ˂ 1.46

Enrichment 10 to 36 wt% 235U

Moderating Materials None, Water, Nitric Acid, Sulfuric Acid, Hydrocarbon, CF2

Reflecting Materials None, Water, Concrete, BeO, Hydrocarbon Material, Iron, 

Graphite

Absorber Materials Boron, Aluminum, Steel, Stainless Steel, Hydrocarbon 

Material

Geometry Homogenous and Heterogeneous Spheres, Hemispheres, 

Cylinders, Cuboids, Single Unit and Arrays

The staff noted that Section 6b.3 of the PSAR did not include the technical practices for each 

controlled parameter as described on pages 72 – 74 of the ISG for NUREG-1537, Part 2. The 

technical practices, which describe requirements for the use of each controlled parameter (both 

in establishing controls for the parameter and for modeling it in criticality analysis), are part of 

the principal design criteria for the RFP. The margin provided by conservatively modeling 

controlled parameters is part of the overall margin of subcriticality that gives reasonable 

assurance that all processes will be subcritical under normal and credible abnormal conditions. 

Initially, the details of how NCSEs will handle the controlled parameters was absent from the 

PSAR, and was not included in the NCS Manual submitted in response to RAI 6b.3-30 

(Reference 29). The applicant did submit some representative analysis (discussed below) that 

illustrated how the parameters were dealt with in specific cases, but these were not reviewed in 

detail. Therefore, additional information was requested, and in response to RAI 6b.3-31 

(Reference 101), the applicant subsequently committed to meet the acceptance criteria for the 

use of each parameter in the ISG, and thus adequately responded to the staff’s requests for 

additional information on this subject.
Engineered Safety Features

6-38

On page 6b-12 of the PSAR, the applicant stated that heterogeneous effects are not considered 

applicable because the uranium enrichment is less than 20 wt%. In the response to RAI 6b.3-6 

(Reference 21), the applicant elaborates by quoting LA-12808, “Nuclear Criticality Safety 

Guide,” such that heterogeneous effects can be ignored for uranium above 6 percent 

enrichment. Staff concluded that this response was insufficient as some guidance, specifically, 

Figures 22 through 25 of LA-10860-MS, “Critical Dimensions of Systems Containing U-235, 

Pu-239, and U-233,” showed heterogeneity can have effects at greater than 6 percent 

enrichment. Therefore, additional information was requested, and in response to RAI 6.3-27 

(Reference 25), the applicant stated it will consider heterogeneity effects when establishing 

NCS controls and limits, where such are credible and relevant. Staff finds SHINE’s commitment 

to the consideration of heterogeneity acceptable to develop the NCS controls and limits to be 

provided in the FSAR. The staff will confirm that SHINE adequately considers heterogeneity in 

NCS controls and limits in the evaluation of SHINE’s FSAR.

In response to RAI 6b.3-16 (Reference 21), the applicant stated that specifics of mass control 

have not yet been defined and will be determined as part of the detailed design. However, it 

stated that if mass is used as a controlled parameter, determinations of mass will be based on 

either weighing the material and assuming the entire mass is SNM or conducting physical 

measurements to establish the actual weight percent of SNM in the material. The staff finds 

these are consistent with the commitments for mass control in the ISG Augmenting 

NUREG-1537, and are therefore acceptable.

The applicant’s response to RAI 6b.3-17 (Reference 21) stated that preliminary criticality 

scoping safety assessments assume theoretical densities of dry and moderated fissile solids 

and that SHINE does not anticipate utilizing density as a control for criticality safety 

purposes. The staff finds the applicant’s commitments regarding density controls to be 

consistent with the guidance in the ISG Augmenting NUREG-1537, and therefore acceptable.

The applicant’s response to RAI 6b.3-18 (Reference 21) stated that SHINE plans to assume an 

enrichment of 21 percent to conservatively address uranium enrichment. In response to 

RAI 6b.3-29 (Reference 25), the applicant stated that enrichment will be independently verified 

upon receipt. The details of how enrichment is verified will be determined prior to operation. 

Because the material should be, generally, slightly less than 20 percent enriched, the 

enrichment will not be further controlled throughout the facility design. The staff finds that these 

details are not necessary for construction and may be reasonably left for consideration in 

SHINE’s operating license application.

The applicant’s response to RAI 6b.3-19 (Reference 21) stated that preliminary criticality safety 

assessments have been performed using worst-case credible reflection conditions and that 

reflection will not be a controlled parameter. The staff finds the applicant’s commitments 

regarding reflection to be consistent with the guidance in the ISG Augmenting NUREG-1537, 

and therefore acceptable.

In response to RAI 6b.3-8 (Reference 21), the applicant stated that preliminary criticality scoping 

safety assessments include optimum moderation conditions. In response to RAI 6b.3-28 

(Reference 25), the applicant states that if it uses moderation as a controlled parameter, it will 

meet the acceptance criteria outlined in NUREG-1520. The staff finds the applicant’s 

commitments regarding moderation as a controlled parameter to be consistent with the 

guidance, and therefore acceptable.
Engineered Safety Features

6-39

In response to RAI 6b.3-9 (Reference 21), the applicant stated that preliminary criticality scoping 

safety assessments have been performed at optimum concentration, with the exception of the 

evaluation for the liquid waste processing tanks. The liquid waste processing tanks are the only 

tanks or vessels at the SHINE facility that are not criticality-safe by geometry where fissionable 

material exists outside the TSV. The staff finds this response to be acceptable because these 

tanks are not expected to ever contain an appreciable amount of fissionable material. SHINE 

will apply limits on uranium concentration to these tanks to ensure that uranium-bearing solution 

which exceeds the NCS limit is prevented from entering non-favorable geometry vessels.

 

On page 6b-16 of the PSAR, the applicant states that interaction may be used as a controlled 

parameter if engineered controls are used to maintain minimum separation. Enhanced 

administrative controls are used where engineered controls are not feasible. In response to RAI 

6b.3-10 (Reference 21), the applicant stated that preliminary criticality scoping safety 

assessments use interaction control in conjunction with geometry control related to arrays of 

cylindrical tanks and storage rack arrays. These geometric designs control the spacing 

between storage locations in racks and the spacing of tanks containing fissile material. The 

structural integrity of the features will be designed such that proper spacing between fissile 

material units is maintained during normal and credible abnormal conditions. The staff 

concludes that these commitments are consistent with guidance in the ISG Augmenting 

NUREG-1537, and the staff therefore finds them acceptable.

On page 6b-16, the applicant states that use of neutron absorption as a controlled parameter is 

acceptable by following ANSI/ANS-8.21-1995 (Reference 67). Neutron spectra will be 

considered in the evaluation of absorber effectiveness. The applicant does not commit to

ANSI/ANS-8.5-1986 as it does not anticipate using raschig rings. As such, staff finds the 

applicant’s commitments regarding neutron absorption as a control to be consistent with the 

guidance in the ISG Augmenting NUREG-1537, and therefore acceptable.

In response to RAI 6b.3-21 (Reference 21), the applicant stated that the preliminary criticality 

scoping safety assessments use volume control as a controlled parameter. Volume control 

entails assuming an optimum concentration in a spherical geometry of fissile material, as well as 

full water reflection and allows for criticality safety to be demonstrated without regard to 

geometric shape. These commitments are consistent with guidance in the ISG and the staff 

therefore finds them acceptable.

The applicant did make several additional commitments in its PSAR regarding implementation 

of the various controlled parameters. Page 1-4 of the PSAR describes the preferred hierarchy 

of controls as follows:

 

a) The facility and equipment is designed so that significant quantities of fissionable 

material cannot be placed in a favorable configuration for criticality.

b) Engineered controls.

c) Administrative controls (e.g., limitations on allowed movements and processes involving 

special nuclear material [SNM]).
Engineered Safety Features

6-40

Page 6b-11 contains an essentially equivalent list:

a) Passive engineered.

b) Active engineered.

c) Enhanced administrative.

d) Simple administrative.

The two lists are equivalent, as geometry is almost always controlled passively, and therefore 

incorporates both the preference for passive control and preferred reliance on geometry. The 

lists are consistent with the guidance in the ISG Augmenting NUREG-1537, Part 2, and 

therefore the staff finds these commitments acceptable. The staff will verify SHINE’s 

commitments to using volume as a controlled parameter in the evaluation of SHINE’s FSAR.

The applicant submitted the following NCS analyses and calculations in the form of preliminary 

criticality scoping safety assessments. The NCS analyses and calculations do not necessarily 

contain all elements that would be required for construction and operation of the facility. It is 

anticipated that additional hazards and controls will be identified as the facility and process 

design develops. The analyses submitted were:

• ATKINS-NS-DAC-SHN-15-04, Rev. 0, “Single Parameter Subcritical Limits for 

Homogeneous 21 wt% 235U Uranyl Sulfate, Uranium Oxide, and Uranium Metal.”

• ATKINS-NS-DAC-SHN-15-2, Rev. 0, “Criticality Safety Calculations for the Preliminary 

Design of Annular Tanks for the SHINE Medical Isotope Facility.”

• ATKINS-NS-TR-SHN-15-06, Rev. 1, “Criticality Safety Evaluation for the SHINE Target 

Solution Preparation System.”

The staff determined that a detailed review of these preliminary analyses was not necessary for

the issuance of a construction permit, and therefore did verify that the NCS calculations fell 

within the AOA established in the validation report. However, due to SHINE’s preferential 

reliance on passive engineered NCS features, additional information is necessary to confirm the 

adequacy of the implementation of SHINE’s NCS design criteria prior to the completion of 

construction. Specifically, SHINE’s RPF design must provide reasonable assurance that all 

RPF processes will remain subcritical under all normal and credible abnormal conditions. 

Therefore, the staff recommends that the construction permit include a condition that 

requires that, prior to the completion of construction, SHINE submit periodic reports to 

the NRC, at intervals not to exceed 6 months from the date of the construction permit. 

As described in the proposed permit conditions in Appendix A of this SER, these reports 

shall provide summaries of the criticality safety analysis for the affected processes that

include the following: (1) a list of identified criticality hazards, (2) a list of controlled 

parameters, (3) a description of evaluated normal and abnormal conditions, (4) a 

description of the licensee’s approach to meeting the double contingency principle, and 

(5) a list of anticipated passive and active engineered controls, including any 

assumptions, to ensure the process(es) will remain subcritical under normal and credible 

abnormal conditions. 

Following the review of the SHINE’s preliminary NCS Manual and a preliminary review of the 

NCSEs, the staff noted inconsistencies in the applicant’s treatment of fissile isotopes other than 

U-235. Notably, on pages 4b-4 and -5 of the PSAR, the applicant states that small quantities of 
Engineered Safety Features

6-41

Pu-239 and U-233 may be present in recycled target solution. These nuclides are generally 

accepted as being more reactive than U-235 at thermal neutron energies. However, staff noted 

that there was no mention of these nuclides in the preliminary NCSEs and NCS manual 

provided in response to RAI 6b.3-30 (Reference 25 and 29). The staff’s modeling of the SHINE 

systems using the SCALE code determined that inclusion of these nuclides in SHINE’s NCS 

analysis may result in a statistically significant increase in keff. While the staff finds that SHINE’s 

preliminary NCS analyses and calculations are sufficient to allow SHINE to proceed with 

construction, due to SHINE’s inconsistent treatment of fissile isotopes, additional information is 

necessary to confirm the adequacy of the implementation of SHINE’s NCS design criteria prior 

to the completion of construction. Specifically, SHINE’s RPF design must provide reasonable 

assurance that all RPF processes will remain subcritical under all normal and credible abnormal 

conditions. 

Therefore, the staff recommends that the construction permit include a condition that 

requires that, prior to the completion of construction, SHINE submit periodic reports to 

the NRC, at intervals not to exceed 6 months from the date of the construction permit. 

As described in the proposed permit conditions in Appendix A of this SER, these reports 

shall provide the relevant NCSEs that address the reactivity contributions from all fissile 

isotopes or SHINE shall apply an additional subcritical margin to account for neglecting 

these nuclides. The treatment of fissile nuclides other than U-235, whether through the 

NCSEs or the addition of subcritical margin, shall demonstrate that all RPF processes 

will remain subcritical under all normal and credible abnormal conditions.

On the basis of its review, including the confirmatory permit conditions listed above, the staff 

finds that the level of detail provided on nuclear criticality safety for the RPF satisfies the 

applicable acceptance criteria of NUREG-1537, Part 2, Section 6b.3, allowing the staff to make, 

with reasonable assurance, the following relevant findings, subject to the satisfaction of the 

permit conditions in this section of the SER: 

(1) The applicant will have in place an NCS program.

(2) The applicant will have in place personnel who are qualified to develop, implement, 

and maintain the NCS program consistent with the facility organization and 

administration and management measures.

(3) The applicant’s conduct of operations will be based on NCS technical practices, which 

will ensure that the fissile material will be possessed, stored, and used safely.

(4) The applicant will develop, implement, and maintain a criticality accident alarm system 

that meets applicable acceptance criteria. 

Therefore, the staff finds that SHINE’s NCS program, as described in PSAR Section 6b.3 and 

supplemented by the applicant’s responses to RAIs, is sufficient and meets the applicable 

regulatory requirements and guidance for the issuance of a construction permit in accordance 

with 10 CFR 50.35, subject to the aforementioned conditions. Those safety features and 

components requiring additional information to confirm adequacy of design have been identified 

for inclusion as conditions in the SHINE construction permit. The proposed conditions must be 

satisfied prior to the completion of construction. Further technical or design information outside 

of the scope of these construction permit conditions and as may be required to complete the 
Engineered Safety Features

6-42

safety analysis of the SHINE facility, including information tracked through regulatory 

commitments, can reasonably be left for later consideration during the evaluation of SHINE’s 

FSAR, as part of the review of an operating license application.

6b.4.6 Probable Subjects of Technical Specifications

In accordance with 10 CFR 50.34(a)(5), the staff evaluated the sufficiency of the applicant’s 

identification and justification for the selection of those variables, conditions, or other items 

which are determined to be probable subjects of technical specifications for the SHINE RPF 

ESFs, with special attention given to those items which may significantly influence the final 

design.

SHINE PSAR Sections 6b.2.1.6, “Design Bases,” 6b.2.4, “Radioisotope Production Facility 

Engineered Safety Features Technical Specifications,” and 6b.3.2, “Technical Specifications,” 

state that potential variables, conditions, or other items that will be probable subjects of a 

technical specification associated with the RPF confinement systems and components, ESFs, 

and nuclear criticality safety are provided in SHINE PSAR Chapter 14. However, in Tables 

6b.1-1, “Summary of RPF Design Basis Accidents and ESF Provided for Mitigation,” 6b.2-1, 

“Radioisotope Production Facility Design Basis Accident Consequence Determination,” 6b.2-2, 

“Radioisotope Production Facility Confinement Safety Functions,” 6b.3-1, “Tanks Subject to 

Criticality-Safety Controls,” and 6b.3-2, “Nuclear Criticality Safety Program Elements and 

Requirement Bases,” SHINE identified structures systems and components, events, and 

programs likely to be addressed by technical specifications.

In Table 14a2-1, “SHINE Facility Proposed Parameters for Technical Specifications,” SHINE 

identified the criticality safety design, including the condition of criticality safe sumps, and RPF 

confinement isolation valves as likely to be the subject of LCOs.

In PSAR Section 14b.2.1, “Safety Limits for Processing Irradiated Special Nuclear Material 

Outside of the Reactor,” SHINE stated that “SLs are derived for criticality accident prevention 

based on the Nuclear Criticality Safety Program, and also from an Integrated Safety Analysis 

(ISA). Limits are specified, using the double-contingency principal, to avoid a criticality accident. 

Limits are set with a conservative margin.”

In response to RAI 6b.2-9 (Reference 21), the applicant stated the ESF function for both the IF 

and RPF consists of confinement systems, ventilation systems, and control systems. 

Post-accident mitigation is accomplished by confinement of radioactive or hazardous material to 

controlled areas to mitigate the consequences of design basis accidents (DBAs). This 

confinement occurs by shutting isolation dampers in the ventilation systems or isolation valves 

in lines penetrating the confinement area when parameters are determined to be outside 

predefined limits. This function is known as the ESF function. The control systems that perform 

this function are known as the ESFAS in the IF, and the Radiological Integrated Control System 

(RICS) in the RPF.
Engineered Safety Features

6-43

Probable subjects of proposed TS for the IF and RPF ESF confinement systems are provided in 

PSAR Table 14a2-1, Section 3.4, and are also referenced for the RPF specifically in PSAR 

Section 14b.3.2. Per PSAR Table 14a2-1, the following Confinement LCOs will be developed:

• TPS glove box system or confinement (IF)

• IU and TOGS shielded cell confinement isolation valves (IF)

• Confinement isolation valves (RPF)

Probable subjects of proposed TS for the IF and RPF ESF ventilation systems are provided in 

PSAR Table 14a2-1, Section 3.5, and are also referenced for the RPF specifically in PSAR 

Subsection 14b.3.3. Per PSAR Table 14a2-1, the following LCOs will be developed:

• RVZ1 and RVZ2 isolation dampers (IF and RPF)

Probable subjects of proposed TS for ESF control and actuation are provided in PSAR Table 

14a2-1, and are also referenced for the RPF specifically in PSAR Subsections 14b.3.1 and 

14b.3.5. Per PSAR Table 14a2-1, the following LCOs will be developed:

• ESFAS input to the TRPS, including the required operable channels per future TS 

Table 3.2.1 (i.e., TS Table 3.2.1 will include channel(s) monitored, number of channels 

required, allowable value, nominal setpoint, permissible bypass, or other conditions) (IF).

• RICS (initiates the isolation functions necessary to achieve confinement in the RPF)

The probable subjects of TS for ESF equipment are described above. Specific details related to 

these probable subjects, such as periodic functional testing of damper closure, room isolation, 

minimum airflow rates, automatic system shutdown and startup, and activation setpoints will be 

provided in the SHINE TS, which will be provided as part of the SHINE operating license 

application.

Based on the information provided in PSAR Chapters 6b and 14, as well as PSAR Table 14a2-1 

and supplemented by the response to RAI 6b.2-9, the staff finds that the identification and 

justification for the selection of those variables, conditions, or other items which are determined 

to be probable subjects of technical specifications for the SHINE RPF ESFs are sufficient and 

meet the applicable regulatory requirements and acceptance criteria of NUREG-1537 for the 

issuance of a construction permit in accordance with 10 CFR 50.35. A detailed evaluation of 

technical specifications, including LCOs and surveillance requirements, will be performed during 

the review of the SHINE operating license application.

6b.5 Summary and Conclusions

The staff evaluated the descriptions and discussions of SHINE’s RPF ESFs, including probable 

subjects of technical specifications, as described in SHINE PSAR Section 6b and supplemented 

by the applicant’s response to RAIs, and finds that the preliminary design of SHINE’s RPF 

ESFs, including the principal design criteria; design bases; and information relative to materials 

of construction, general arrangement, and approximate dimensions: (1) provides reasonable 

assurance that the final design will conform to the design basis, and (2) meets all applicable 

regulatory requirements and acceptance criteria in NUREG-1537. 
Engineered Safety Features

6-44

On the basis of these findings and subject to the conditions identified above, the staff has made 

the following conclusions for the issuance of a construction permit in accordance with 

10 CFR 50.35 and 50.40:

(1) SHINE has described the proposed design of the RPF ESF systems, including, but not 

limited to, the principal architectural and engineering criteria for the design, and has 

identified the major features or components incorporated therein for the protection of 

the health and safety of the public.

(2) Further technical or design information required to complete the safety analysis will be 

supplied in the FSAR.

(3) There is reasonable assurance that: (i) safety questions will be satisfactorily resolved 

at or before the latest date stated in the application for completion of construction of 

the proposed facility, and (ii) taking into consideration the site criteria contained in 

10 CFR Part 100, the proposed facility can be constructed and operated at the 

proposed location without undue risk to the health and safety of the public.

(4) There is reasonable assurance: (i) that the construction of the SHINE facility will not 

endanger the health and safety of the public, and (ii) that construction activities can be 

conducted in compliance with the Commission’s regulations.

(5) The issuance of a permit for the construction of the facility would not be inimical to the 

common defense and security or to the health and safety of the public.
7-1

INSTRUMENT AND CONTROL SYSTEMS

Instrument and control (I&C) systems comprise the sensors, electronic circuitry, displays, and 

actuating devices that provide the information and means to safely control the SHINE Medical 

Technologies, Inc. (SHINE or the applicant) irradiation facility (IF) and radioisotope production 

facility (RPF) and to avoid or mitigate accidents. Together, the IF and RPF constitute the 

SHINE facility.

Instruments are provided to monitor, indicate, and record such operating parameters as neutron 

flux density, target solution temperature, coolant flow and temperature, and radiation intensities 

in selected areas around the SHINE facility. Certain l&C systems will automatically shut down 

the SHINE irradiation units (IUs) when a safety parameter reaches a predetermined set point. 

I&C subsystems may also be designed to actuate engineered safety features (ESFs) upon the 

detection of abnormal conditions.

This chapter of the SHINE construction permit safety evaluation report (SER) describes the 

review and evaluation of the U.S. Nuclear Regulatory Commission (NRC) staff (the staff) of the 

preliminary design of the SHINE IF and RPF I&C systems as presented in Chapter 7, 

“Instrument and Control Systems,” of the SHINE Preliminary Safety Analysis Report (PSAR), as 

supplemented by the applicant’s responses to requests for additional information (RAIs).

7a Irradiation Facility Instrument and Control Systems

SER Section 7a, “Irradiation Facility Instrumentation and Control Systems,” provides an 

evaluation of the preliminary design of SHINE’s IF I&C systems as presented in SHINE PSAR 

Section 7a2, “Irradiation Facility Instrument and Control Systems,” within which, SHINE 

describes the design of I&C systems, target solution vessel (TSV) process control system, TSV 

reactivity protection system, ESFs, ESF actuation system (ESFAS), control console and display 

information, and radiation monitoring systems.

7a.1 Areas of Review

The staff reviewed SHINE PSAR Section 7a2 against applicable regulatory requirements using 

appropriate regulatory guidance and standards to assess the sufficiency of the preliminary 

design and performance of SHINE’s IF I&C systems. As part of this review, the staff evaluated 

descriptions and discussions of SHINE’s IF I&C systems, with special attention to design and 

operating characteristics, unusual or novel design features, and principal safety considerations. 

The preliminary design of SHINE’s IF I&C systems was evaluated to ensure the sufficiency of 

principal design criteria, design bases, and information relative to materials of construction, 

general arrangement, and approximate dimensions sufficient to provide reasonable assurance 

that the final design will conform to the design basis. In addition, the staff reviewed SHINE’s 

identification and justification for the selection of those variables, conditions, or other items that 

are determined to be probable subjects of technical specifications for the facility, with special 

attention given to those items that may significantly influence the final design.

Areas of review for this section included IF I&C control systems, process control descriptions, 

reactivity protection system, ESFAS, control console and display information, and radiation 

monitoring systems. Within these review areas, the staff assessed the preliminary analysis of 

I&C systems needed to monitor key parameters and variables, maintain parameters and 
Instrument and Control Systems

7-2

variables within prescribed operating ranges, alert operators when operating ranges are 

exceeded, assure safety limits are not exceeded, and initiate mitigating systems and 

components important to safety.

7a.2 Summary of Application

SHINE utilizes independent I&C systems to protect and control the neutron driver and TSV 

associated with each irradiation unit in the IF. The I&C systems in the IF include reactivity 

protection systems, reactivity control systems, radiation detection systems, ESFAS, and control 

room and instrument displays.

SHINE PSAR Section 7a2 provides the preliminary design of the I&C systems, the TSV process 

control description, the TSV reactivity protection system, the ESFAS, the control console and 

display information, and the radiation monitoring systems.

7a.3 Regulatory Basis and Acceptance Criteria

The staff reviewed SHINE PSAR Section 7a2 against applicable regulatory requirements, using 

appropriate regulatory guidance and standards, to assess the sufficiency of the preliminary 

design and performance of SHINE’s I&C systems for the issuance of a construction permit. In 

accordance with paragraph (a) of Title 10 of the Code of Federal Regulations (10 CFR) 50.35, 

“Issuance of construction permits,” a construction permit authorizing SHINE to proceed with 

construction may be issued once the following findings have been made:

(1) SHINE has described the proposed design of the facility, including, but not limited to, 

the principal architectural and engineering criteria for the design, and has identified the 

major features or components incorporated therein for the protection of the health and 

safety of the public.

(2) Such further technical or design information as may be required to complete the safety 

evaluation, and which can reasonably be left for later consideration, will be supplied in 

the final safety analysis report (FSAR).

(3) Safety features or components, if any, which require research and development have 

been described by SHINE and a research and development program will be conducted 

that is reasonably designed to resolve any safety questions associated with such 

features or components. 

(4) On the basis of the foregoing, there is reasonable assurance that: (i) such safety 

questions will be satisfactorily resolved at or before the latest date stated in the 

application for completion of construction of the proposed facility, and (ii) taking into 

consideration the site criteria contained in 10 CFR Part 100, the proposed facility can 

be constructed and operated at the proposed location without undue risk to the health 

and safety of the public.

With respect to the last of these findings, the staff notes that the requirements of 

10 CFR Part 100 are specific to nuclear power reactors, and therefore not applicable to the 

SHINE facility. However, the staff evaluated SHINE’s site specific conditions using site criteria 

similar to 10 CFR Part 100, by using the guidance in NUREG-1537. The staff’s review 

evaluated the geography and demography of the site; nearby industrial, transportation, and 
Instrument and Control Systems

7-3

military facilities; site meteorology; site hydrology; and site geology, seismology, and 

geotechnical engineering to ensure that issuance of the construction permit will not be inimical 

to public health and safety.

The staff’s evaluation of the preliminary design of SHINE’s I&C systems does not constitute 

approval of the safety of any design feature or specification. Such approval will be made 

following the evaluation of the final design of SHINE’s I&C systems, as described in the FSAR 

as part of SHINE’s operating license application.

7a.3.1 Applicable Regulatory Requirements

The applicable regulatory requirements for the evaluation of SHINE’s IF I&C systems are as 

follows:

10 CFR 50.34, “Contents of applications; technical information,” paragraph (a), 

“Preliminary safety analysis report.”

As required by 10 CFR 50.34(a)(3)(i), SHINE must describe the principal design criteria for its 

facility in the PSAR; however, SHINE is not required to follow 10 CFR Part 50, Appendix A, 

“General Design Criteria [GDCs] for Nuclear Power Plants,” as this appendix only applies to 

nuclear power reactors. Nonetheless, SHINE has applied several of the GDCs to the 

preliminary design of its I&C systems in the IF. As such, the staff based its review, in part, on 

SHINE’s application of the following GDCs to its I&C systems:

• GDC 2, “Design Bases for Protection Against Natural Phenomena.”

• GDC 4, “Environmental and Dynamic Effects Design Bases.”

• GDC 5, “Sharing of Structures, Systems, and Components.”

• GDC 10, “Reactor Design.”

• GDC 12, “Suppression of Reactor Power Oscillations.”

• GDC 13, “Instrumentation and Control.”

• GDC 15, “Reactor Coolant System Design.”

• GDC 16, “Containment Design.”

• GDC 17, “Electric Power Systems.”

• GDC 19, “Control Room.”

• GDC 20, “Protection System Functions.”

• GDC 21, “Protection System Reliability and Testability.”

• GDC 22, “Protection System Independence.”

• GDC 23, “Protection System Failure Modes.”

• GDC 24, “Separation of Protection and Control Systems.”

• GDC 25, “Protection System Requirements for Reactivity Control Malfunctions.”

• GDC 26, “Reactivity Control System Redundancy and Capability.”

• GDC 27, “Combined Reactivity Control Systems Capability.”

• GDC 28, “Reactivity Limits.”

• GDC 29, “Protection Against Anticipated Operational Occurrences.”

7a.3.2 Regulatory Guidance and Acceptance Criteria

In applying guidance and acceptance criteria, the staff used its judgment as to which 

acceptance criteria were relevant to SHINE’s proposed facility, as much of this guidance was 

originally developed for nuclear reactors. Given the similarities in SHINE’s proposed facility and 
Instrument and Control Systems

7-4

non-power research reactors, the staff used established guidance documents and the 

Commission’s regulations to determine the acceptance criteria for demonstrating compliance 

with 10 CFR regulatory requirements. For example, the staff used: 

• NUREG-1537, Part 1, “Guidelines for Preparing and Reviewing Applications for the 

Licensing of Non-Power Reactors, Format and Content,” issued February 1996 

(Reference 4).

• 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 (Reference 5).

• “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 (Reference 6).

• “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 (Reference 7).

As stated in the ISG Augmenting NUREG-1537, the staff determined that certain guidance 

originally developed for heterogeneous non-power research and test reactors is applicable to 

aqueous homogenous facilities and production facilities. SHINE used this guidance to inform 

the design of its facility and prepare its PSAR. The staff’s use of reactor-based guidance in its 

evaluation of the SHINE PSAR is consistent with the ISG Augmenting NUREG-1537.

As appropriate, additional guidance (e.g., NRC regulatory guides, Institute of Electrical and 

Electronics Engineers [IEEE] standards, American National Standards Institute/American 

Nuclear Society [ANSI/ANS] standards) has been used in the staff’s review of SHINE’s PSAR. 

The use of additional guidance is based on the technical judgment of the reviewer, as well as 

references in NUREG-1537, Parts 1 and 2; the ISG Augmenting NUREG-1537, Parts 1 and 2; 

and the SHINE PSAR. Additional guidance documents used to evaluate SHINE’s PSAR are 

provided as references in Appendix B of this SER.

7a.4 Review Procedures, Technical Evaluation, and Evaluation Findings 

The staff performed an evaluation of the technical information presented in SHINE PSAR 

Section 7a, as supplemented by responses to RAIs, to assess the sufficiency of the preliminary 

design and performance of SHINE’s IF I&C systems for the issuance of a construction permit, in 

accordance with 10 CFR 50.35(a). The staff determined that the sufficiency of preliminary 

design and performance of SHINE’s IF I&C systems is determined by ensuring the design and 

performance meet applicable regulatory requirements, guidance, and acceptance criteria. 

While the technical evaluation of these systems provided in this section is specific to the SHINE 

IF, the staff’s review considers the interface of these systems between the IF and RPF as part 

of a comprehensive technical evaluation. The results of this technical evaluation are 

summarized in Section 7a.5, “Summary and Conclusions.”
Instrument and Control Systems

7-5

For the purposes of issuing a construction permit, the preliminary design of the SHINE I&C 

systems may be adequately described at a functional or conceptual level. The staff evaluated 

the sufficiency of the preliminary design of the SHINE I&C systems based on the applicant’s 

design methodology and ability to provide reasonable assurance that the final design will 

conform to the design bases with adequate margin for safety. As such, the staff’s evaluation of 

the preliminary design of SHINE’s I&C systems does not constitute approval of the safety of any 

design feature or specification. Such approval will be made following the evaluation of the final 

design of SHINE’s I&C systems, as described in the FSAR, as part of SHINE’s operating license 

application.

7a.4.1 Summary Description

The staff evaluated the sufficiency of SHINE’s summary description of its IF I&C systems, as 

described in SHINE PSAR Section 7a2.1, “Summary Description,” using the guidance and 

acceptance criteria from Section 7.1, “Summary Description,” of NUREG-1537, Parts 1 and 2.

As stated in Section 7.1 of NUREG-1537, Part 1, the description of the I&C systems should, in 

part, summarize the “technical aspects, safety, philosophy, and objectives of the I&C system 

design,” including discussions on types of instruments and classifications of systems.

Section 7a2.1 of the SHINE PSAR provides brief descriptions of the types of equipment, types 

of parameters monitored, and the types of reactivity control measures for the principal irradiation 

facility I&C systems, including the TSV reactivity protection systems (TRPS), the TSV reactivity 

control systems (TRCS), the ESFAS, and control room instruments and displays. The principal 

IF I&C systems are briefly described in SHINE PSAR Sections 7a2.1.1 through 7a2.1.5, as 

discussed below. Additionally, a description of the human-machine interface is provided in 

SHINE PSAR Section 7a2.6, “Control Console and Display Information.” 

Based on the flexibility in the design details and the ability to review design once it is completed 

the staff determined that descriptions of actuating logic for the TSVs are not necessary for the 

issuance of a construction permit. Such logic will be evaluated in the SHINE FSAR. 

SHINE PSAR Section 7a2.1.1, “Reactivity Protection Systems,” introduces the TRPS, a digital 

control system covering the TSV and entire primary system boundary. The TRPS is responsible 

for monitoring various essential inputs and has the ability to mitigate abnormal or accident 

conditions through automated protective actions. The protective actions include opening the 

TSV dump valves, de-energizing the neutron driver, closing the TSV fill valves, and closing the 

TSV dump tank outlet valves. This system is classified as a safety-related system. Additional 

details of the TRPS design is provided in SHINE PSAR Section 7a2.4, “TSV Reactivity 

Protection System,” and Figures 7a2.1-1, “Safety Approach for TSV Shutdown,” and 7a2.2-1, 

“I&C System Block Diagram for Irradiation Facility.”

SHINE PSAR Section 7a2.1.2, “Reactivity Control Systems,” introduces the TRCS as the TSV 

process control system (TPCS) used for control of normal operations, startup, and shutdown of 

the neutron driver, and the TSV residing in the IU cell. This system is a separate digital control 

system and is independent from the TRPS. The TPCS is non-safety-related and is further 

described in SHINE PSAR Section 7a2.3, “TSV Process Control Description.”

SHINE PSAR Section 7a2.1.3, “Reactivity Detection Systems,” briefly describes the 

independent neutron flux detection system (NFDS), which is the primary means for monitoring 

the reactivity and power of the sub-critical assembly system (SCAS). The NFDS measures 
Instrument and Control Systems

7-6

neutron flux outside of the TSV and provides input to the TPCS and TRPS. These are 

redundant and independent signal channels that represent the neutron flux in the SCAS. The 

NFDS has independent high flux trip settings that are input signals to the TRPS. Should the 

neutron flux measured at the detectors exceed the allowable operating conditions, the NFDS 

triggers the TRPS to perform its protective action. There is a separate independent NFDS for 

each IU cell in the SHINE facility. This system is further described in PSAR Section 7a2.4.3, 

“NFDS Description.”

SHINE PSAR Section 7a2.1.4, “Engineered Safety Features Actuation System,” briefly 

describes the ESFAS as consisting of two independent, safety-related, analog relay trains. 

Upon sensing essential parameters outside predefined limits, the ESFAS is designed to 

automatically activate the ESF mitigative actions for the affected IU cell and TSV off gas system 

(TOGS) shielded cell. During activation, the ESFAS isolates systems that penetrate the IU cell 

and TOGS shielded cell boundaries, including the bubble-tight dampers in the radiologically 

controlled area (RCA) ventilation system Zone 1 (RVZ1) cells. In addition, the ESFAS signals 

the TRPS to actuate its trip mechanisms. The ESFAS can isolate any individual IU cell or all of 

the IU cells or any combination, depending on the need. This system is further described in 

PSAR Section 7a2.5, “Engineered Safety Features Actuation System.”

SHINE PSAR Section 7a2.1.5, “Control Room and Instrument Displays,” briefly describes the IF 

centralized control room, from which each IU within the IF is monitored and controlled. The 

SHINE PSAR states that the TRPS and the TPCS each have independent and electrically 

isolated, dedicated operator workstations, complete with annunciation, alarm, and operator 

interface displays. The work stations are housed in two consoles, which are redundant in 

nature and can be operated simultaneously and independently. This system is further 

described in PSAR Section 7a2.6.

Additionally, the control room houses the annunciation for the radiation monitoring that occurs 

throughout the IF and the RPF. The IF and RPF utilize a continuous air monitoring system 

(CAMS) and radiation area monitoring system (RAMS) for continuous radiological monitoring. 

The RAMS and CAMS are strategically placed throughout the facility to alert personnel of any 

potential radiation hazards. These systems are further described in PSAR Section 7a2.7, 

“Radiation Monitoring Systems.”

On the basis of its review, the staff has determined that the level of detail provided in the 

summary description of the SHINE IF I&C systems demonstrates an adequate design basis for

a preliminary design and satisfies the applicable acceptance criteria discussed in NUREG-1537, 

Part 2, Section 7.1.

Therefore, the staff finds that the summary description of the SHINE IF I&C systems, as

described in SHINE PSAR Section 7a2.1, is sufficient and meets the applicable regulatory 

requirements and guidance for the issuance of a construction permit in accordance with 

10 CFR 50.35. Further technical or design information required to complete the safety analysis 

may reasonably be left for later consideration. The staff will confirm that the final design 

conforms to this design basis during the evaluation of SHINE’s FSAR.

7a.4.2 Design of Instrumentation and Control Systems

The staff evaluated the sufficiency of the design of SHINE’s IF I&C systems, as described in 

SHINE PSAR Section 7a2.2, “Design of Instrumentation and Control Systems,” and 

supplemented by responses to RAIs, in part, by reviewing the design criteria, design basis 
Instrument and Control Systems

7-7

requirements, system description, and system performance analysis of SHINE’s I&C systems, 

as described below, using the guidance and acceptance criteria from Section 7.2, “Design of 

Instrumentation and Control Systems,” NUREG-1537, Parts 1 and 2.

As stated in Section 7.2.1, “Design Criteria,” of NUREG-1537 Part 1, the “applicant should [in 

part] discuss the criteria for developing the design bases for the I&C systems,” including the 

“basis for evaluating the reliability and performance of the I&C systems[.]”

Section 7a2.2.1, “Design Criteria,” of the SHINE PSAR indicates that the IF design criteria were 

adopted from analogous design criteria in nuclear power plants and adapted for applicability to 

the unique design of the SHINE facility. The specific design criteria and design bases used by 

the applicant are summarized in SHINE PSAR Table 7a2.2-1, “Design Criteria for the TSV 

Instrumentation and Control System.”

The staff reviewed SHINE PSAR Section 7a2.2 consistent with NUREG-1537, Part 1, 

Section 7.2.2, “Design-Basis Requirements,” which states, in part, that the “design bases for the 

I&C system, subsystems, and components should include the following, as applicable:

• The range of values that monitored variables may exhibit for normal operation, shutdown 

conditions, and for postulated accidents.

• The specification of precision and accuracy requirements for the instruments, control 

subsystems, or components. . .”

Design basis requirements for the SHINE IF I&C systems are discussed in SHINE PSAR 

Table 7a2.2-1.

During its review, the staff noted that SHINE PSAR Table 7a2.2-2, “IF Verification Matrix Design 

Criteria, Bases, Description” (Sheet 9 of 10) states, in part, that “the amount and rate of 

reactivity increases during the fill and irradiation processes are limited through physical and 

control system design to ensure that the effects of postulated reactivity accidents can neither: 

(1) result in damage to the primary system boundary greater than limited local yielding; nor, 

(2) sufficiently disturb the target solution vessel, its support structures or other target solution 

vessel internals to impair significantly the capability to drain the target solution vessel.” 

However, the staff determined that additional information was needed for these statements to 

determine if the design provides reasonable assurance that the design criteria will be met. This 

information is necessary to satisfy the design bases described in NUREG-1537, Part 1, 

Section 7.2, “Design-Basis Requirements,” and demonstrate the adequacy of the design basis 

of the SHINE I&C systems.

Therefore, in RAI 7a2.2-1 (Reference 14), the staff requested additional information for the 

statements in SHINE PSAR Table 7a2.2-2 (Sheet 9 of 10). In particular, the staff requested 

information for details on the anticipated accuracy for the reactivity control and the criteria for 

determining that draining of the TSV is not impaired. 

In its response to RAI 7a2.2-1 (Reference 21), the applicant stated the following:

Part 1 of NUREG-1537 . . . states, in part, that the design bases for the 

instrument and control (I&C) system, subsystems, and components should 

include the range of values that monitored variables may exhibit for normal 

operation, shutdown conditions, and for postulated accidents. SHINE will 
Instrument and Control Systems

7-8

monitor neutron flux and process variables during the entire fill (Mode 1) and 

irradiation (Mode 2) process. Neutron flux is plotted to obtain the 1/M versus the 

fill volume (height) during the fill process and continuously monitored during the 

irradiation process to ensure that measured parameters do not exceed 

acceptable limits. Reactivity in the TSV will only be directly controlled during the 

startup process and when the target solution is drained. The nominal margin to 

critical (e.g., five percent by volume) will be controlled through the 1/M process. 

The expected accuracies for the parameters used for reactivity monitoring are 

provided in Table 7a2.2-1-1. The expected ranges of variables for normal 

operation and postulated accidents are also provided in the table. The accuracy 

of the overall margin to critical during startup is described in the SHINE 

Response to RAI 7a2.3-1.

During the irradiation (Mode 2) process, the control system does not directly 

control the reactivity. The physical design and characteristics of the subcritical 

assembly (e.g., natural convection cooling design, nuclear feedback coefficients) 

determine the reactivity response. The target solution does not require reactivity 

monitoring after it is transferred into the TSV dump tank during Mode 3, because 

it is contained in a criticality-safe geometry and is passively cooled by the light 

water pool.

The draining of the TSV is monitored by valve position indication on the TSV 

dump valves and TSV level instrumentation. Only one of the two dump valves is 

required to function to meet the required drain rate for the TSV. Periodic 

surveillance testing will be performed to verify the draining of the TSV is not 

impaired by observing the rate of TSV level decrease following opening of the 

TSV dump valves, which will be compared to the required rate. Discrepancies 

identified during surveillance testing (e.g., significant decrease in flow rate) will 

be placed into the Corrective Action Program.

Additionally, in its response to RAI 7a2.2-1 (Reference 21), the applicant provided PSAR 

Table 7a2.2-1-1, “Reactivity Monitoring Variables, Ranges, and Accuracies (Design Basis for 

Reactivity Control and Protection Trips-Nominal),” which gives the range and accuracies of the 

monitored variables. The applicant further stated that the nominal margin to critical volume in 

the TSV is, for example, 5 percent. The staff finds these figures demonstrate that the 

anticipated range of values will be monitored by the planned equipment and is acceptable.

Regarding the overall accuracy or uncertainty, the applicant’s response to RAI 7a2.2-1 

references the response to RAI 7a2.3-1, which then references the response to RAI 4a2.6-6,

(all contained in Reference 21), which cites an example of overall uncertainty of 30 percent. 

The staff finds that this response provides information on precision and accuracy as discussed 

in the design-basis criteria discussed in NUREG-1537, Part 1, Section 7.2, and is therefore 

acceptable. The staff will confirm that the final design conforms to this design basis during the 

evaluation of SHINE FSAR.

As stated in Section 7.2.3, “System Description,” of NUREG-1537, Part 1, the system 

description should, in part, “include equipment and major components as well as block, logic, 

and schematic diagrams.”

SHINE PSAR Section 7a2.2.3, “System Description,” further describes IF I&C systems, 

equipment, and major components. Block, logic, and schematic diagrams are provided in 
Instrument and Control Systems

7-9

PSAR Figure 7a2.2-1, “I&C System Block Diagram for Irradiation Facility.” The applicant also 

provides hardware and software descriptions, as well as software flow diagrams for digital 

computer systems.

Descriptions of system operational and support requirements, operator interface requirements, 

and methodology and acceptance criteria used to establish and calibrate the trip or actuation 

setpoints or interlock functions are not necessary for the issuance of a construction permit. 

Evaluation of these requirements will occur during the review of SHINE’s FSAR.

As stated in Section 7.2.4, “System Performance Analysis,” of NUREG-1537, Part 1, the 

applicant should, in part, “conduct a performance analysis of the proposed I&C system to 

ensure the design criteria and design bases are met and license requirements for the 

performance of the system are specified.”

SHINE PSAR Section 7a2.2.4, “System Performance Analysis,” presents an analysis of how the 

system design meets the design criteria and design bases for the TRPS. The discussion 

touches on accuracy, reliability, adequacy, and timeliness of I&C system action, trip setpoint 

drift, redundancy, independence, and how the single-failure criterion is to be met to ensure safe 

operation and safe shutdown of the affected IU. The PSAR sections listed below provide 

information on various design aspects:

• 7a2.2.4.1, “IU Trip Design Basis.”

• 7a2.2.4.1.1, “Safety Functions and Corresponding Protective/Mitigative Actions for 

Design Basis Events.”

• 7a2.2.4.1.2, “Variables Monitored to Control Protective/Mitigative Action.”

• 7a2.2.4.1.3, “Variable Monitored Having Spatial Dependence.”

• 7a2.2.4.1.4, “Range of Transient and Steady-State Conditions During Normal, Abnormal, 

and Accident Conditions.”

• 7a2.2.4.1.5, “Functional Degradation of Safety System Performance.”

• 7a2.2.4.2, “Analysis.”

• 7a2.2.4.2.1, “TSV Trip Function Conformance to Applicable Criteria.”

• 7a2.2.4.2.1.1, “General Functional Requirement Conformance.”

• 7a2.2.4.2.1.2, “Single Failure Criterion Conformance.”

• 7a2.2.4.2.1.3, “Independence for Control and IU Trip Conformance.”

• 7a2.2.4.2.1.4, “Derivation of System Inputs Conformance.”

• 7a2.2.4.2.1.5, “Requirements on Bypassing Trip Functions Conformance.”

• 7a2.2.4.2.1.6, “Requirements on Setpoint Determination and Multiple Setpoint 

Conformance.”
Instrument and Control Systems

7-10

• 7a2.2.4.2.1.7, “Requirements for Completion of Trip Conformance.”

• 7a2.2.4.2.1.8, “Requirements for Manual Control of Trip Conformance.”

The staff finds that the level of detail provided on systems performance analysis satisfies the 

criteria of NUREG-1537, Part 2, Section 7.2, and demonstrates an adequate design basis for a 

preliminary design. A more detailed evaluation of information (e.g., ranges of transient and 

steady-state conditions and requirements for multiple setpoints and trip criteria) will occur during 

the review of SHINE’s FSAR, at which time the staff will confirm that the final design conforms 

to this design basis.

On the basis of its review, the staff has determined that the level of detail provided in the design 

of the SHINE IF I&C systems demonstrates an adequate design basis for a preliminary design 

and satisfies the applicable acceptance criteria of NUREG-1537, Part 2, Section 7.2.

Therefore, the staff finds that the design of the SHINE IF I&C systems, as described in SHINE 

PSAR Section 7a2.2, is sufficient and meets the applicable regulatory requirements and 

guidance for the issuance of a construction permit in accordance with 10 CFR 50.35. Further 

technical or design information required to complete the safety analysis (e.g., information 

related to the design of instrument and control systems designed to prevent an inadvertent 

criticality event) may reasonably be left for later consideration. The staff will confirm that the 

final design conforms to the design basis during the evaluation of SHINE’s FSAR.

7a.4.3 Target Solution Vessel Process Control Description

The staff evaluated the sufficiency of the preliminary design of SHINE’s TPCS, as described in 

SHINE PSAR Section 7a2.3, “TSV Process Control Description,” and supplemented by the 

applicant’s responses to RAIs, in part, by reviewing the description, process control systems, 

and sequence and interlock summary of SHINE’s TPCS using the guidance and acceptance 

criteria from Section 7.3, “Reactor Control System,” of NUREG-1537, Parts 1 and 2.

Consistent with the review procedures in NUREG-1537, Part 2, Section 7.3, the staff confirmed 

that TPCS information for all normal functions and systems described in other chapters of the 

PSAR are addressed in this section and verified that all design bases are justified, as presented 

in SHINE PSAR Section 7a2.3 and other relevant chapters of the PSAR.

NUREG-1537, Part 2, Section 7.3 states, in part, that the “RCS [Reactor Control System] 

[should be] designed to provide for the reliable control of the reactor power level, rate of change 

of power levels . . . during reactor startup, the full range of normal operation, and shutdown.”

Section 7a2.3 of the SHINE PSAR describes the preliminary design of the TPCS, including 

descriptions of the four operational modes.

In its review, the staff noted that PSAR Section 7a2.3.2.1, “Mode 1 - Startup Mode,” states that 

the startup process calculates the subcritical multiplication factor M from the neutron flux level 

and plots 1/M versus the fill volume (height). This is then compared to a graph of predicted 

acceptance values for the same parameter. However, it was not clear how bias and 

uncertainties associated with the benchmarking of criticality calculations, together with the 

expected variability in process parameters and instrumentation readings were being considered.
Instrument and Control Systems

7-11

Therefore, in RAI 7a2.3-1 (Reference 14), the staff requested additional information regarding 

the uncertainties in the computations described in SHINE PSAR Section 7a2.3.2.1, including a 

quantitative estimate of the expected overall uncertainty in their subcritical reactivity values 

during startup. This information is necessary to demonstrate the adequacy of the design basis 

of the SHINE TPCS and satisfy the acceptance criteria of NUREG-1537, Part 2, Section 7.3, 

which states, in part, that the “RCS should give continuous indication of the neutron flux from 

subcritical source multiplication level through the licensed maximum power range.”

In its response to RAI 7a2.3-1 (Reference 21), the applicant stated:

The SHINE Response to RAI 4a2.6-6 discusses the uncertainties in keff and 

subcritical reactivity during startup. As discussed in that response, SHINE plans 

to use a volume margin to critical approach, which will determine the target 

solution volume below critical during startup and calculate the subcritical 

reactivity by multiplying this volume margin to critical by the reactivity worth per 

volume. By using this approach, the bias of criticality calculations is eliminated 

from the calculation process.

Regarding the overall accuracy or uncertainty, the applicant’s response to RAI 7a2.2-1 cites an 

example of overall uncertainty of 30 percent. The staff finds this value to be acceptable, 

considering the values in PSAR Table 7a2.2-1-1, and satisfies the acceptance criteria of 

NUREG-1537, Part 2, Section 7.3, by demonstrating an adequate design basis in support for a 

preliminary design, which is commensurate with the precision and accuracy of the variable 

being measured. The staff will confirm that the final design conforms to this design basis during 

the evaluation of SHINE’s FSAR.

On the basis of its review, the staff has determined that the level of detail provided on the TPCS 

demonstrates an adequate design basis for a preliminary design and satisfies the applicable 

acceptance criteria of NUREG-1537, Part 2, Section 7.3, allowing the staff to make the relevant 

finding that the applicant has described the normal operating modes of the facility.

Therefore, the staff finds that the preliminary design of the SHINE TPCS, as described in SHINE 

PSAR Section 7a2.3 and supplemented by the applicant’s response to an RAI, is sufficient and 

meets the applicable regulatory requirements and guidance for the issuance of a construction 

permit in accordance with 10 CFR 50.35. Further technical or design information required to 

complete the safety analysis may reasonably be left for later consideration. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

7a.4.4 Target Solution Vessel Reactivity Protection System

The staff evaluated the sufficiency of the preliminary design of SHINE’s TRPS, as described in 

SHINE PSAR Section 7a2.4 and supplemented by the applicant’s responses to RAIs, in part, by 

reviewing the description and performance analysis of SHINE’s TRPS using the guidance and 

acceptance criteria from Section 7.4, “Reactor Protection System,” of NUREG-1537, Parts 1 

and 2.

Consistent with the review procedures in NUREG-1537, Part 2, Section 7.4, the staff compared 

the design bases for the TRPS with the PSAR description of possible hazards to the facility or 

personnel that could be prevented or mitigated by timely protective action, as presented in 

SHINE PSAR Section 7a2.3 and other relevant chapters of the PSAR.
Instrument and Control Systems

7-12

During its review, the staff noted that SHINE PSAR Section 7a2.4.1, “TRPS Description,” states 

that the only nuclear trips are on high neutron flux, source range, and high range. However, 

there are no apparent anticipatory trip(s) provided for high startup rates or short periods, which 

are usually needed to adequately limit the fission reaction during high-reactivity transients.

Therefore, in RAI 7a2.4-1 (Reference 14), the staff requested analyses supporting the adequacy 

of the trips described in SHINE PSAR, Section 7a2.4.1, to avoid a possibly unacceptable high 

reactivity transient, considering uncertainties and possible reactivity insertion events. 

Additionally, the applicant was requested to explain why a period trip in the source range would 

not be necessary, noting that the source range period is already provided. This information is 

necessary to demonstrate the adequacy of the design basis of the SHINE TRPS and satisfy the 

acceptance criteria of NUREG-1537, Part 2, Section 7.4, which states, in part, that “the reactor 

[SHINE facility] should have operable protection capability in all operating modes and 

conditions, as analyzed in the SAR.”

In response to RAI 7a2.4-1 (Reference 20), the applicant stated, in part, that “[t]ransient 

behavior will be analyzed using a transient system model currently being completed. Transient 

systems modeling will be used for the adequacy of the current nuclear trips to prevent 

unacceptably high reactivity transients as well as to verify protection capability in all operating 

modes, including determining if there is a need for a period trip during filling operations.” The 

results of this analysis will be used as part of the detailed design and provided in the FSAR.

The staff finds that this response satisfies the acceptance criteria of NUREG-1537, Part 2, 

Section 7.4, and demonstrates an adequate design basis for a preliminary design. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

On the basis of its review, the staff has determined that the level of detail the applicant provided 

on the TRPS demonstrates an adequate design basis for a preliminary design and satisfies the 

applicable acceptance criteria of NUREG-1537, Part 2, Section 7.4, allowing the staff to make 

the following relevant findings: (1) the preliminary design reasonably ensures that the design 

bases can be achieved, (2) the TRPS is designed to maintain function or to achieve safe 

shutdown, and (3) the TRPS is designed to prevent or mitigate hazards to the facility or escape 

of radiation.

Therefore, the staff finds that the preliminary design of the SHINE TRPS, as described in SHINE 

PSAR Section 7a2.4 and supplemented by the applicant’s response to an RAI, is sufficient and 

meets the applicable regulatory requirements and guidance for the issuance of a construction 

permit in accordance with 10 CFR 50.35. Further technical or design information required to 

complete the safety analysis may reasonably be left for later consideration. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

7a.4.5 Engineered Safety Features Actuation System

The staff evaluated the sufficiency of the preliminary design of SHINE’s IF ESFAS, as described 

in SHINE PSAR Section 7a2.5, in part, by reviewing the description and performance analysis 

of SHINE’s ESFAS using the guidance and acceptance criteria from Section 7.5, “Engineered 

Safety Features Actuation Systems,” of NUREG-1537, Parts 1 and 2.
Instrument and Control Systems

7-13

Consistent with the review procedures in NUREG-1537, Part 2, Section 7.5, the staff compared 

the design criteria and bases of the ESFAS with the ESFs and accident scenarios, as well as 

comparing the design and functional descriptions of the ESFAS with the applicable criteria and 

functions in NUREG-1537, Part 2, Chapters 6, “Engineered Safety Features,” and 13, “Accident 

Analysis.”

On the basis of its review, the staff has determined that the level of detail provided on the 

ESFAS demonstrates an adequate design basis for a preliminary design and satisfies the 

applicable acceptance criteria of NUREG-1537, Part 2, Section 7.5, allowing the staff to make 

the following relevant findings: (1) the applicant has analyzed postulated accident scenarios at 

the facility, including accidents for which consequence mitigation by the ESFAS is required or 

planned, (2) the applicant has considered the environments in which the ESFs are expected to 

operate, and (3) the design considerations of the ESFAS give reasonable assurance that the 

final design of the system will detect changes in measured parameters as designed and will 

initiate timely actuation of the applicable ESF.

Therefore, the staff finds that the preliminary design of the SHINE ESFAS, as described in 

SHINE PSAR Section 7a2.5, is sufficient and meets the applicable regulatory requirements and 

guidance for the issuance of a construction permit in accordance with 10 CFR 50.35. Further 

technical or design information required to complete the safety analysis may reasonably be left 

for later consideration. The staff will confirm that the final design conforms to this design basis

during the evaluation of SHINE’s FSAR.

7a.4.6 Control Console and Display Information

The staff evaluated the sufficiency of the preliminary design of SHINE’s control console and 

display information, as described in SHINE PSAR Section 7a2.6, in part, by reviewing the 

operator interface description; control room and display access; operator interface data entry; 

display interface hardware and software; human factors engineering; static annunciator and 

fixed status display; alarm and event display; human machine interface; and display 

independence using the guidance and acceptance criteria from Section 7.6, “Control Console 

and Display Instruments,” of NUREG-1537, Parts 1 and 2.

Consistent with the review procedures of NUREG-1537, Part 2, Section 7.6, the staff compared 

the design bases and functional requirements of the control console and display information 

with other facility systems. These systems are designed to display the critical measurement 

values, provide annunciator functions, and provide a dynamic interface.

On the basis of its review, the staff has determined that the level of detail provided on the 

control console and display information demonstrates an adequate design basis for a 

preliminary design and satisfies the applicable acceptance criteria of NUREG-1537, Part 2, 

Section 7.6, allowing the staff to make the following finding: the applicant has indicated that 

systems important to the safe and effective operation of the facility (i.e., TRPS and TPCS) will 

be displayed at the control console.

Therefore, the staff finds that the preliminary design of the SHINE control console and display 

information, as described in SHINE PSAR Section 7a2.6, is sufficient and meets the applicable 

regulatory requirements and guidance for the issuance of a construction permit in accordance 

with 10 CFR 50.35. Further technical or design information required to complete the safety 

analysis may reasonably be left for later consideration. The staff will confirm that the final 

design conforms to this design basis during the evaluation of SHINE’s FSAR.
Instrument and Control Systems

7-14

7a.4.7 Radiation Monitoring Systems

The staff evaluated the sufficiency of the preliminary design of SHINE’s radiation monitoring 

systems, as described in SHINE PSAR Section 7a2.7, in part, by reviewing the descriptions and 

locations of SHINE’s radiation monitoring equipment using the guidance and acceptance criteria 

from Section 7.7, “Radiation Monitoring Systems,” of NUREG-1537, Parts 1 and 2.

Consistent with the review procedures of NUREG-1537, Part 2, Section 7.7, the staff confirmed 

that the design bases for the radiation monitoring systems and equipment I&Cs are consistent 

with giving reliable indication of the presence of radiation or release of radioactive material in

the various areas monitored and in the monitored effluent streams from the facility.

On the basis of its review, the staff has determined that the level of detail provided on the 

radiation monitoring systems demonstrates an adequate design basis for a preliminary design 

and satisfies the applicable acceptance criteria of NUREG-1537, Part 2, Section 7.7, allowing 

the staff to make the following relevant findings: (1) the preliminary design of the radiation 

monitoring system has been described and is applicable to the anticipated sources of radiation, 

(2) the PSAR discusses all likely radiation and radioactive sources anticipated at the SHINE 

facility and describes equipment, systems, and devices that will give reasonable assurance that 

all such sources will be identified and accurately evaluated, and (3) the radiation monitoring 

systems described in the PSAR give reasonable assurance that dose rates and effluents at the 

facility will be acceptably detected, and that the health and safety of the facility staff, 

environment, and public will be acceptably protected.

Therefore, the staff finds that the preliminary design of the SHINE radiation monitoring systems, 

as described in SHINE PSAR Section 7a2.7 is sufficient and meets the applicable regulatory 

requirements and guidance for the issuance of a construction permit in accordance with 

10 CFR 50.35. Further technical or design information required to complete the safety analysis 

may reasonably be left for later consideration. The staff will confirm that the final design 

conforms to this design basis during the evaluation of SHINE’s FSAR.

7a.4.8 Probable Subjects of Technical Specifications

In accordance with 10 CFR 50.34(a)(5), the staff evaluated the sufficiency of the applicant’s 

identification and justification for the selection of those variables, conditions, or other items 

which are determined to be probable subjects of technical specifications for the SHINE facility 

I&C systems, with special attention given to those items which may significantly influence the 

final design.

Section 7a2.2.4, “System Performance Analysis,” of the SHINE PSAR states that “potential 

variables, conditions, or other items that will be probable subjects of technical specifications 

associated with the IF instrumentation and control systems are provided in Chapter 14.” 

Similarly, PSAR Sections 7a2.6.9, “TRPS/TPCS and Display Independence,” and 7a2.7.4.3, 

“Audible and Visual Alarm Devices,” indicate that probable subjects of technical specifications 

associated with the TRPS, TPCS, and display instrumentation and radiation monitoring 

instrumentation are provided in PSAR Chapter 14, “Technical Specifications.” SHINE PSAR 

Section 14a2.6, “Administrative Controls,” lists hot cell audible and visual warnings as part of 

the facility’s as low as is reasonably achievable (ALARA) program, which will be covered by 

administrative controls in the technical specifications.
Instrument and Control Systems

7-15

Based on the information provided in Sections 7a2.2.4, 7a2.6.9, 7a2.7.3, “Radiation Monitor 

Locations,” and 14a2.6 of the SHINE PSAR, the staff finds that the identification and justification 

of hot cell audible and visual warnings as part of the SHINE facility’s ALARA program as a 

probable subject of technical specifications for the SHINE IF I&C systems is sufficient and 

meets the applicable regulatory requirements for the issuance of a construction permit in 

accordance with 10 CFR 50.35. A detailed evaluation of technical specifications, including 

limiting conditions for operation (LCOs) and surveillance requirements, will be performed during 

the review of SHINE’s operating license application.

7a.5 Summary and Conclusions

The staff evaluated descriptions and discussions of SHINE’s IF I&C systems, including probable 

subjects of technical specifications, as described in Section 7a2 of the SHINE PSAR and 

supplemented by the applicant’s responses to RAIs, and finds that the preliminary design of 

SHINE’s IF I&C systems, including the principal design criteria, design bases, and information 

relative to materials of construction, general arrangement, and approximate dimensions: 

(1) provides reasonable assurance that the final design will conform to the design basis, and 

(2) meets all applicable regulatory requirements and acceptance criteria in NUREG-1537. The 

staff further notes that any modifications to the preliminary design of the SHINE I&C systems 

and operating procedures can be readily implemented in the final design and after facility 

construction activities have been completed.

 

On the basis of these findings, the staff has made the following conclusions for the issuance of 

a construction permit in accordance with 10 CFR 50.35:

(1) SHINE has described the proposed design of IF I&C systems, including, but not limited 

to, the principal architectural and engineering criteria for the design, and has identified 

the major features or components incorporated therein for the protection of the health 

and safety of the public.

(2) Further technical or design information required to complete the safety analysis of the 

IF I&C systems may reasonably be left for later consideration in the FSAR.

(3) There is reasonable assurance that, taking into consideration the site criteria contained 

in 10 CFR Part 100, the proposed facility can be constructed and operated at the 

proposed location without undue risk to the health and safety of the public.

7b Radioisotope Production Facility Instrument and Control Systems

Section 7b, “Radioisotope Production Facility Instrumentation and Control Systems,” provides 

an evaluation of the preliminary design of SHINE’s RPF I&C systems as presented in SHINE 

PSAR Section 7b, “Radioisotope Production Facility Instrument and Control Systems,” within 

which, SHINE describes the design of instrumentation and control systems, production facility 

process control systems, ESFs and alarming, control console and display instrumentation, and 

radiation monitoring systems.
Instrument and Control Systems

7-16

7b.1 Areas of Review

The staff reviewed Section 7b, “Radioisotope Production Facility Instrument and Control 

System,” of the SHINE PSAR against applicable regulatory requirements using appropriate 

regulatory guidance and standards to assess the sufficiency of the preliminary design and 

performance of SHINE’s RPF I&C systems. As part of this review, the staff evaluated 

descriptions and discussions of SHINE’s RPF I&C systems, with special attention to design and 

operating characteristics, unusual or novel design features, and principal safety considerations. 

The preliminary design of SHINE’s RPF I&C systems was evaluated to ensure the sufficiency of 

principal design criteria, design bases, and information relative to materials of construction, 

general arrangement, and approximate dimensions, sufficient to provide reasonable assurance 

that the final design will conform to the design basis. In addition, the staff reviewed SHINE’s 

identification and justification for the selection of those variables, conditions, or other items 

which are determined to be probable subjects of technical specifications for the facility, with 

special attention given to those items which may significantly influence the final design.

Areas of review for this section included RPF I&C process control descriptions, ESFs and 

alarming, control console and display information, and radiation monitoring systems. Within 

these review areas, the staff assessed the preliminary analysis of I&C systems needed to 

monitor key parameters and variables, maintain parameters and variables within prescribed 

operating ranges, alert operators when operating ranges are exceeded, assure safety limits are 

not exceeded, and initiate mitigating systems and components important to safety.

7b.2 Summary of Application

The SHINE RCA integrated control system (RICS) monitors and controls both safety-related 

and non-safety-related components within the RPF.

Section 7b of the SHINE PSAR provides the preliminary design of the RPF I&C systems, 

including the RPF process control systems, ESFs and alarming, control console and display 

information, and radiation monitoring systems. 

7b.3 Regulatory Basis and Acceptance Criteria

The staff reviewed SHINE PSAR Section 7b against applicable regulatory requirements, using 

appropriate regulatory guidance and standards, to assess the sufficiency of the preliminary 

design and performance of SHINE’s I&C systems for the issuance of a construction permit. In 

accordance with paragraph (a) of 10 CFR 50.35, a construction permit authorizing SHINE to 

proceed with construction may be issued once the following findings have been made:

(1) SHINE has described the proposed design of the facility, including, but not limited to, 

the principal architectural and engineering criteria for the design, and has identified the 

major features or components incorporated therein for the protection of the health and 

safety of the public.

(2) Such further technical or design information as may be required to complete the safety 

analysis, and which can reasonably be left for later consideration, will be supplied in 

the FSAR. 

(3) Safety features or components, if any, which require research and development have 

been described by SHINE and a research and development program will be conducted 
Instrument and Control Systems

7-17

that is reasonably designed to resolve any safety questions associated with such 

features or components.

(4) On the basis of the foregoing, there is reasonable assurance that: (i) such safety 

questions will be satisfactorily resolved at or before the latest date stated in the 

application for completion of construction of the proposed facility, and (ii) taking into 

consideration the site criteria contained 10 CFR Part 100, the proposed facility can be 

constructed at the proposed location without undue risk to the health and safety of the 

public.

With respect to the last of these findings, the staff notes that the requirements of 

10 CFR Part 100 are specific to nuclear power reactors, and therefore not applicable to the 

SHINE facility. However, the staff evaluated SHINE’s site specific conditions using site criteria 

similar to 10 CFR Part 100, by using the guidance in NUREG-1537. The staff’s review 

evaluated the geography and demography of the site; nearby industrial, transportation, and 

military facilities; site meteorology; site hydrology; and site geology, seismology, and 

geotechnical engineering to ensure that issuance of the construction permit will not be inimical 

to public health and safety.

The staff’s evaluation of the preliminary design of SHINE’s I&C systems does not constitute 

approval of the safety of any design feature or specification. Such approval will be made 

following the evaluation of the final design of SHINE’s I&C systems as described in the FSAR as 

part of SHINE’s operating license application.

7b.3.1 Applicable Regulatory Requirements

The applicable regulatory requirements for the evaluation of SHINE’s RPF I&C systems are as 

follows:

10 CFR 50.34, “Contents of applications; technical information,” paragraph (a), 

“Preliminary safety analysis report.”

As required by 10 CFR 50.34(a)(3)(i), SHINE must describe the principal design criteria for its 

facility in the PSAR; however, SHINE is not required to follow 10 CFR Part 50, Appendix A, 

“General Design Criteria for Nuclear Power Plants,” as this appendix only applies to nuclear 

power reactors. Nonetheless, SHINE has applied several of the GDCs to the preliminary design 

of its I&C systems in the RPF. As such, the staff based its review, in part, on SHINE’s 

application of the following GDCs to its I&C systems:

• GDC 2, “Design Bases for Protection Against Natural Phenomena.”

• GDC 4, “Environmental and Dynamic Effects Design Bases.”

• GDC 5, “Sharing of Structures, Systems, and Components.”

• GDC 10, “Reactor Design.”

• GDC 12, “Suppression of Reactor Power Oscillations.”

• GDC 13, “Instrumentation and Control.”

• GDC 15, “Reactor Coolant System Design.”

• GDC 16, “Containment Design.”

• GDC 17, “Electric Power Systems.”

• GDC 19, “Control Room.”

• GDC 20, “Protection System Functions.”
Instrument and Control Systems

7-18

• GDC 21, “Protection System Reliability and Testability.”

• GDC 22, “Protection System Independence.”

• GDC 23, “Protection System Failure Modes.”

• GDC 24, “Separation of Protection and Control Systems.”

• GDC 25, “Protection System Requirements for Reactivity Control Malfunctions.”

• GDC 26, “Reactivity Control System Redundancy and Capability.”

• GDC 27, “Combined Reactivity Control Systems Capability.”

• GDC 28, “Reactivity Limits.”

• GDC 29, “Protection Against Anticipated Operational Occurrences.”

7b.3.2Regulatory Guidance and Acceptance Criteria

In applying guidance and acceptance criteria, the staff used its judgment as to which 

acceptance criteria were relevant to SHINE’s proposed facility, as much of this guidance was 

originally developed for nuclear reactors. Given the similarities in SHINE’s proposed facility and 

non-power research reactors, the staff used established guidance documents and the 

Commission’s regulations to determine the acceptance criteria for demonstrating compliance 

with 10 CFR regulatory requirements. For example, the staff used: 

• NUREG-1537, Part 1.

• NUREG-1537, Part 2.

• Final ISG Augmenting NUREG-1537, Part 1.

• Final ISG Augmenting NUREG-1537, Part 2.

As stated in the ISG Augmenting NUREG-1537, the staff determined that certain guidance 

originally developed for heterogeneous non-power research and test reactors is applicable to 

aqueous homogenous facilities and production facilities. SHINE used this guidance to inform 

the design of its facility and prepare its PSAR. The staff’s use of reactor-based guidance in its 

evaluation of the SHINE PSAR is consistent with the ISG Augmenting NUREG-1537.

As appropriate, additional guidance (e.g., NRC regulatory guides, IEEE standards, ANSI/ANS 

standards) has been used in the staff’s review of SHINE’s PSAR. The use of additional 

guidance is based on the technical judgment of the reviewer, as well as references in 

NUREG-1537, Parts 1 and 2; the ISG Augmenting NUREG-1537, Parts 1 and 2; and the SHINE 

PSAR. Additional guidance documents used to evaluate SHINE’s PSAR are provided as 

references in Appendix B of this SER.
Instrument and Control Systems

7-19

7b.4 Review Procedures, Technical Evaluation, and Evaluation Findings

The staff performed an evaluation of the technical information presented in Section 7b of 

SHINE’s PSAR, as supplemented by the applicant’s responses to RAIs, to assess the 

sufficiency of the preliminary design and performance of SHINE’s RPF I&C systems for the 

issuance of a construction permit, in accordance with 10 CFR 50.35(a). As discussed in 

Section 7b.3, “Regulatory Basis and Acceptance Criteria,” of this SER, the staff has determined 

that the sufficiency of preliminary design and performance of SHINE’s RPF I&C systems is 

determined by ensuring the design and performance meet applicable regulatory requirements, 

guidance, and acceptance criteria. While the technical evaluation of these systems provided in 

this section is specific to the SHINE RPF, the staff’s review considers the interface of these 

systems between the IF and RPF as part of a comprehensive technical evaluation. The results 

of this technical evaluation are summarized in Section 7b.5, “Summary and Conclusions.”

For the purposes of issuing a construction permit, the preliminary design of the SHINE I&C 

systems may be adequately described at a functional or conceptual level. The staff evaluated 

the sufficiency of the preliminary design of the SHINE I&C systems based on the applicant’s 

design methodology and ability to provide reasonable assurance that the final design will 

conform to the design bases with adequate margin for safety. As such, the staff’s evaluation of 

the preliminary design of SHINE’s I&C systems does not constitute approval of the safety of any 

design feature or specification. Such approval will be made following the evaluation of the final 

design of SHINE’s I&C systems, as described in the FSAR, as part of SHINE’s operating license 

application.

7b.4.1 Summary Description

The staff evaluated the sufficiency of SHINE’s summary description of its RPF I&C systems, as 

described in SHINE PSAR Section 7b.1, “Summary Description,” using the guidance and 

acceptance criteria from Section 7b.1, “Summary Description,” of the ISG Augmenting 

NUREG-1537, Parts 1 and 2.

As stated in Section 7b.1 of the ISG Augmenting NUREG-1537, Part 1, the description of the 

I&C systems should, in part, summarize the “description of the I&C systems, including the 

design bases; the safety, considerations, and objectives; the operational characteristics of the 

production facility that determine or limit the I&C design; and the ways in which the various 

subsystems constitute the whole and interact to contribute to its essential functions. This 

summary should also include schematic, logic, and flow diagrams illustrating the various 

subsystems.”

Section 7b.1 of the SHINE PSAR provides a summary description of the RPF I&C systems that 

includes the design bases; the safety, considerations, and objectives; the operational 

characteristics of the RPF that determine or limit the I&C design; and the ways in which the 

various subsystems constitute the whole and interact to contribute to its essential functions.

The summary description references schematic, logic, and flow diagrams illustrating the various 

subsystems. The staff finds that each RPF I&C system was designed to perform functions 

commensurate with the complexity of the processes therein. The principal RPF I&C systems 

are briefly described in SHINE PSAR Sections 7b.1.1 through 7b.1.4, and include the RICS 

(Safety-Related/ESF), RICS Description (Process Control), Radiation Monitoring, and Control 

Room and Instrument Displays.
Instrument and Control Systems

7-20

On the basis of its review, the staff has determined that the level of detail provided in the 

summary description of the SHINE RPF I&C systems demonstrates an adequate design basis 

for a preliminary design and satisfies the applicable acceptance criteria of the ISG Augmenting 

NUREG-1537, Part 2, Section 7b.1.

Therefore, the staff finds that the summary description of the SHINE RPF I&C systems, as 

described in SHINE PSAR Section 7b.1, is sufficient and meets the applicable regulatory 

requirements and guidance for the issuance of a construction permit in accordance with 

10 CFR 50.35. Further technical or design information required to complete the safety analysis 

may reasonably be left for later consideration. The staff will confirm that the final design 

conforms to this design basis during the evaluation of SHINE’s FSAR.

7b.4.2 Design of Instrumentation and Control Systems

The staff evaluated the sufficiency of the design of SHINE’s RPF I&C systems, as described in 

SHINE PSAR Section 7b.2, “Design of Instrumentation and Control Systems,” in part, by 

evaluating the design criteria, design basis requirements, system description, and system 

performance analysis of SHINE’s RPF I&C systems using the guidance and acceptance criteria 

from Section 7b.2, “Design of Instrumentation and Control Systems,” of the ISG Augmenting 

NUREG-1537, Parts 1 and 2.

On the basis of its review, the staff has determined that the level of detail provided in design of 

the SHINE RPF I&C systems demonstrates an adequate design basis for a preliminary design 

and satisfies the applicable acceptance criteria of the ISG Augmenting NUREG-1537, Part 2, 

Section 7b.2.

Therefore, the staff finds that the design of the SHINE RPF I&C systems, as described in 

SHINE PSAR Section 7b.2, is sufficient and meets the applicable regulatory requirements and 

guidance for the issuance of a construction permit in accordance with 10 CFR 50.35. Further 

technical or design information required to complete the safety analysis may reasonably be left 

for later consideration. The staff will confirm that the final design conforms to this design basis 

during the evaluation of SHINE’s FSAR.

7b.4.3 Production Facility Process Control Systems

The staff evaluated the sufficiency of the preliminary design of SHINE’s RPF process control 

system, as described in SHINE PSAR Section 7b.3, “Production Facility Process Control 

Systems,” and supplemented by the applicant’s responses to RAIs, in part, by reviewing the 

valve position mimic tables, pump controls, IU cell transfers, fresh target solution loading, and 

recycled target solution loading of SHINE’s RPF process control system using the guidance and 

acceptance criteria from Section 7b.3, “Process Control Systems,” of the ISG Augmenting 

NUREG-1537, Parts 1 and 2.

Consistent with the review procedures in the ISG Augmenting NUREG-1537, Part 2, 

Section 7b.3, the staff confirmed that RPF process control system information for all normal 

functions and systems described in other chapters of the PSAR is addressed in this section and 

verified that all design bases are justified, as presented in SHINE PSAR Section 7b.3 and other 

relevant chapters of the PSAR.
Instrument and Control Systems

7-21

During its review, the staff noted that SHINE PSAR, Section 7b.3 states, in part, that the RICS 

“[m]onitors and controls inter-equipment process fluid transfers in the RPF. For transport 

requiring a pump, the RICS controls the ability of the pump to be energized, and for specific 

transfers, provides controlled fluid flow transfers....”

The staff determined that the application provided insufficient information for the staff to 

conclude that the RPF instrumentation would be adequate to detect excessive deviations from 

critical process variables. Therefore, the staff issued RAI 7b.3-1 (Reference 14), in which the 

staff requested that the applicant provide additional information regarding the adequacy of the 

facility’s instrumentation to detect deviations from nominal concentrations and quantities of 

fissile materials, should they occur. This information is necessary to demonstrate the adequacy 

of the design basis of the SHINE RPF instrumentation and satisfy the acceptance criteria of the 

ISG Augmenting NUREG-1537, Part 2, Section 7b.3, which states, in part, that “[t]he system 

should be designed with sufficient control of reactivity for all required production and SNM fuel 

reconditioning process operations....”

In its response to RAI 7b.3-1 (Reference 20), the applicant stated the following:

Except for the liquid waste processing tanks downstream of the raffinate hold 

tank (1-UNCS-05T), the RPF tanks that contain fissile materials are designed to 

be criticality-safe for the most reactive uranium concentration, as described in 

Subsection 6b.3.1 of the PSAR. If these RPF tanks are over-filled, the excess 

liquid is contained in criticality-safe geometry configurations. Liquid that overfills 

these tanks is controlled through the use of sumps and drains to the 

criticality-safe sump catch tank.

Before liquid is transferred downstream of the raffinate hold tank (to the liquid 

waste storage tank), the absence of appreciable quantities of fissile material is 

verified, as described in Subsection 9b.7.3.2.2 of the PSAR. This verification will 

include appropriate interlocks or other means to prevent the transfer until the 

verification is completed.

Therefore, the RICS does need to control deviations from nominal concentrations 

and quantities for the purpose of criticality safety. However, the SHINE facility 

will contain appropriate instrumentation to adequately monitor the transfer of 

liquids in the IF and RPF, including tank level indication, flow indication, and leak 

detection, to prevent tank overfills and identify leaks.

The staff finds that this response satisfies the acceptance criteria of the ISG Augmenting 

NUREG-1537, Part 2, Section 7b.3, and demonstrates an adequate design basis for a 

preliminary design. The staff will confirm that the final design conforms to this design basis 

during the evaluation of SHINE’s FSAR.

Based on the information provided in Section 7b.3 of the SHINE PSAR, as supplemented by the 

applicant’s responses to RAIs, the staff finds that the preliminary design of the SHINE RPF 

process controls is sufficient and meets the applicable regulatory requirements and acceptance 

criteria of NUREG-1537 for the issuance of a construction permit in accordance with 

10 CFR 50.35. Further technical or design information required to complete the safety analysis 

may reasonably be left for later consideration in the FSAR.
Instrument and Control Systems

7-22

7b.4.4 Engineered Safety Feature and Alarming

The staff evaluated the sufficiency of the preliminary design of SHINE’s RPF ESF and alarming, 

as described in SHINE PSAR Section 7b.4, “Engineered Safety Feature and Alarming,” as 

supplemented by the applicant’s responses to RAIs, by reviewing the system description, 

annunciation and display, and system performance and analysis of SHINE’s ESF and alarming 

using the guidance and acceptance criteria from Section 7.5, of NUREG-1537, Parts 1 and 2.

Consistent with the review procedures of NUREG-1537, Part 2, Section 7.5, the staff compared 

the design criteria and bases of the ESFAS with the ESFs and accident scenarios, as well as 

compared the design and functional descriptions of the ESFAS with the applicable criteria and 

functions in Chapters 6, “Engineered Safety Features,” and 13, “Accident Analysis.”

Section 7.5 of NUREG-1537, Part 2, states, in part, that “[t]he range and sensitivity of ESF 

actuation system sensors should be sufficient to ensure timely and accurate signals to the 

actuation devices.”

During its review, the staff noted that SHINE PSAR, Section 7b.4.1.2.3, “Uranyl Nitrate 

Conversion System Over Temperature Alarm,” states, in part, that “[t]he RICS monitors the 

temperature of each UNCS [uranyl nitrate conversion system] in the RPF with independent 

redundant sensors. These sensors measure the temperature at the outlet of the UNCS.” 

However, the staff noted that there was insufficient information to confirm the applicant’s 

assertion. Therefore, the staff issued RAI 7b.4-1 (Reference 14), in which the staff requested 

that the applicant provide additional information to justify how the location of temperature 

sensors at the outlet of the UNCS is representative of the process. This information is 

necessary to demonstrate the adequacy of the design basis of the SHINE RPF ESF and 

alarming and satisfy the acceptance criteria of NUREG-1537, Part 2, Section 7.5, which states, 

in part, that “[t]he range and sensitivity of ESF actuation system sensors should be sufficient to 

ensure timely and accurate signals to the actuation devices.”

In its response to RAI 7b.4-1 (Reference 20), the applicant explained that temperature sensors 

will be located at appropriate points representative of the UNCS process, sufficient to ensure 

safe and reliable operation of the system. Specific temperature sensor locations will be 

determined during the detailed design and will be provided in the FSAR. Examples of 

temperature sensor locations, which will be verified as appropriate during detailed design, 

include the following:

(1) Upstream of the uranyl nitrate conversion tank (1-UNCS-01T-A/B) to monitor the feed 

from the molybdenum extraction and purification system (MEPS).

(2) Downstream of the uranyl nitrate conversion tank (1-UNCS-01T-A/B) to measure 

average temperature and prevent bulk boiling and extra vapor input to the vent stack.

(3) Downstream of the heat exchanger for the uranyl nitrate conversion tank 

(1-UNCS-01T-A/B).

(4) Upstream of the extraction contactors (1-UNCS-01Z).

(5) Downstream of the recycle uranyl nitrate hold tank (1-UNCS-06T).
Instrument and Control Systems

7-23

(6) At the uranyl nitrate evaporator vessel (1-UNCS-07T).

(7) At the thermal denitrator (1-UNCS-08T).

The staff finds that this response satisfies the acceptance criteria of NUREG-1537, Part 2, 

Section 7.5, and demonstrates an adequate design basis for a preliminary design. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

On the basis of its review, the staff has determined that the level of detail provided on the RPF 

ESF and alarming demonstrates an adequate design basis for a preliminary design and satisfies 

the applicable acceptance criteria of NUREG-1537, Part 2, Section 7.5, allowing the staff to 

make the following findings: (1) the applicant has analyzed postulated accident scenarios at the 

facility, including accidents for which consequence mitigation by the RPF ESF and alarming is 

required or planned, (2) the applicant has considered the environments in which the ESFs are 

expected to operate, and (3) the design considerations of the RPF ESF and alarming give 

reasonable assurance that the final design of the system will detect changes in measured 

parameters as designed and will initiate timely actuation of the applicable ESF.

Therefore, the staff finds that the preliminary design of the SHINE RPF ESF and alarming, as 

described in SHINE PSAR Section 7b.4 is sufficient and meets the applicable regulatory 

requirements and guidance for the issuance of a construction permit in accordance with 

10 CFR 50.35. Further technical or design information required to complete the safety analysis 

may reasonably be left for later consideration. The staff will confirm that the final design 

conforms to this design basis during the evaluation of SHINE’s FSAR.

7b.4.5 Control Console and Display Instrumentation

The staff evaluated the sufficiency of the preliminary design of SHINE’s RPF control console 

and display information, as described in SHINE PSAR Section 7b.5, “Control Console and 

Display Instrumentation,” using the guidance and acceptance criteria from Section 7.6, “Control 

Console and Display Instruments,” of NUREG-1537, Parts 1 and 2, and Section 7b.5, “Control 

Console and Display Instruments,” of the ISG Augmenting NUREG-1537.

Consistent with the review procedures of NUREG-1537, Part 2, Section 7.6, the staff compared 

the design bases and functional requirements of the control console and display information 

with other facility systems.

SHINE PSAR Section 7b.5 describes the control console or human machine interface (HMI) for 

the RPF, located in the SHINE Medical Isotope Production Facility (MIPF) control room, as an 

extension of the RICS, discussed in more detail in SHINE PSAR Sections 7b.2.1, “Design 

Criteria;” 7b.2.2, “Design Bases;” 7b.2.3, “System Description;” 7b.2.4, “System Performance 

Analysis;” 7b.2.5, “Conclusion;” 7b.3, “Production Facility Process Control Systems;” and 7b.4, 

“Engineered Safety Feature and Alarming. The RICS is used for RPF monitoring and process 

control. In addition, this PSAR section discusses alarms and annunciators for the RPF CAMS, 

RAMS, and criticality accident alarm system (CAAS), discussed in more detail in SHINE PSAR 

Section 7b.6, “Radiation Monitoring Systems.”

On the basis of its review, the staff has determined that the level of detail provided on the 

control console and display information demonstrates an adequate design basis for a 

preliminary design and satisfies the applicable acceptance criteria of NUREG-1537, Part 2, 
Instrument and Control Systems

7-24

Section 7.6, allowing the staff to make the following relevant finding: the applicant has indicated 

that systems important to the safe and effective operation of the facility (i.e., RICS, CAMS, 

RAMS, and CAAS) will be displayed at the control console.

Therefore, the staff finds that the preliminary design of the SHINE control console and display 

information, as described in SHINE PSAR Section 7b.5, is sufficient and meets the applicable 

regulatory requirements and guidance for the issuance of a construction permit in accordance 

with 10 CFR 50.35. Further technical or design information required to complete the safety 

analysis may reasonably be left for later consideration. The staff will confirm that the final 

design conforms to this design basis during the evaluation of SHINE’s FSAR.

7b.4.6 Radiation Monitoring Systems

The staff evaluated the sufficiency of the preliminary design of SHINE’s radiation monitoring 

systems, as described in SHINE PSAR Section 7b.6, in part, by reviewing the descriptions and 

locations of SHINE’s radiation monitoring equipment described in SHINE PSAR Section 7a2.7, 

as well as the description of the CAAS using the guidance and acceptance criteria from 

Section 7.7, “Radiation Monitoring Systems,” of NUREG-1537, Parts 1 and 2.

Consistent with the review procedures of NUREG-1537, Part 2, Section 7.7, the staff confirmed 

that the design bases for the radiation monitoring systems and equipment I&Cs are consistent 

with giving reliable indication of the presence of radiation or release of radioactive material in 

the various areas monitored and in the monitored effluent streams from the facility.

On the basis of its review, the staff has determined that the level of detail provided on the 

radiation monitoring systems demonstrates an adequate design basis for a preliminary design 

and satisfies the applicable acceptance criteria of NUREG-1537, Part 2, Section 7.7, allowing 

the staff to make the following relevant findings: (1) the preliminary design of the radiation 

monitoring system has been described and is applicable to the anticipated sources of radiation, 

(2) the PSAR discusses all likely radiation and radioactive sources anticipated at the SHINE 

facility and describes equipment, systems, and devices that will give reasonable assurance that 

all such sources will be identified and accurately evaluated, and (3) the radiation monitoring 

systems described in the PSAR give reasonable assurance that dose rates and effluents the 

facility will be acceptably detected, and that the health and safety of the facility staff, 

environment, and public will be acceptable protected.

Therefore, the staff finds that the preliminary design of the SHINE radiation monitoring systems, 

as described in SHINE PSAR Section 7b.6 is sufficient and meets the applicable regulatory 

requirements and guidance for the issuance of a construction permit in accordance with 

10 CFR 50.35. Further technical or design information required to complete the safety analysis 

may reasonably be left for later consideration. The staff will confirm that the final design 

conforms to this design basis during the evaluation of SHINE’s FSAR.

7b.4.7 Probable Subjects of Technical Specifications

In accordance with 10 CFR 50.34(a)(5), the staff evaluated the sufficiency of the applicant’s 

identification and justification for the selection of those variables, conditions, or other items 

which are determined to be probable subjects of technical specifications for the SHINE facility 

I&C systems, with special attention given to those items which may significantly influence the 

final design.
Instrument and Control Systems

7-25

SHINE PSAR Section 7b.2.4, “System Performance Analysis,” states, in part, that “potential 

variables, conditions, or other items that will be probable subjects of technical specifications 

associated with the RPF instrumentation and control systems are provided in Chapter 14.” 

Similarly, Sections 7b.3, “Production Facility Process Control Systems,” 7b.4.3, “System 

Performance Analysis,” and 7b.5.1, “System Description,” indicate that probable subjects of 

technical specifications associated with the production facility process control systems, RICS, 

and control console and displays are provided in Chapter 14. Table 14a2-1, “SHINE Facility 

Proposed Parameters for Technical Specifications,” lists the RICS as an LCO for critical 

equipment malfunctions as described in Section 13b.2.4, “Critical Equipment Malfunction,” of 

the PSAR.

Based on the information provided in Sections 7b.2.4, 7b.3, 7b.4.3, 7b.5.1, and Table 14a2-1 of 

the SHINE PSAR, the staff finds that the identification and justification of the RICS as an LCO 

for the SHINE RPF is sufficient and meets the applicable regulatory requirements and 

acceptance criteria of NUREG-1537 for the issuance of a construction permit in accordance with 

10 CFR 50.35. A detailed evaluation of technical specifications, including LCOs and 

surveillance requirements, will be performed during the review of SHINE’s operating license 

application.

7b.5 Summary and Conclusions

The staff evaluated descriptions and discussions of SHINE’s RPF I&C systems, including 

probable subjects of technical specifications, as described in Section 7b of the SHINE PSAR 

and supplemented by the applicant’s responses to RAIs, and finds that preliminary design of 

SHINE’s RPF I&C systems, including the principal design criteria, design bases, and information 

relative to materials of construction, general arrangement, and approximate dimensions: 

(1) provides reasonable assurance that the final design will conform to the design basis, and 

(2) meets all applicable regulatory requirements and acceptance criteria in NUREG-1537.

On the basis of these findings, the staff has made the following conclusions for the issuance of 

a construction permit in accordance with 10 CFR 50.35:

(1) SHINE has described the proposed design of the SHINE facility I&C systems, 

including, but not limited to, the principal architectural and engineering criteria for the 

design, and has identified the major features or components incorporated therein for 

the protection of the health and safety of the public.

(2) Further technical or design information required to complete the safety analysis of the 

SHINE facility I&C systems may reasonably be left for later consideration in the FSAR.

(3) There is reasonable assurance that, taking into consideration the site criteria contained 

in 10 CFR Part 100, the proposed facility can be constructed and operated at the 

proposed location without undue risk to the health and safety of the public.

8-1

ELECTRICAL POWER SYSTEMS

Electrical power systems are designed for operation of the SHINE Medical Technologies, Inc. 

(SHINE or the applicant), irradiation facility (IF) and radioisotope production facility (RPF). In 

addition to normal electrical service, emergency electrical service ensures that, given a loss of 

normal electric service, sufficient power will be available to mitigate accidents in order to: 

(1) shut down the facility and maintain it in a safe shutdown condition, and (2) prevent or 

minimize the offsite release of radioactivity in excess of applicable regulatory requirements and 

guidance.

This chapter of the SHINE construction permit safety evaluation report (SER) describes the 

review and evaluation of the U.S. Nuclear Regulatory Commission (NRC) staff (the staff) of the 

preliminary design of the SHINE IF and RPF electrical power systems, as presented in Chapter 

8, “Electrical Power Systems,” of the SHINE Preliminary Safety Analysis Report (PSAR), as 

supplemented by the applicant’s response to the staff’s request for additional information (RAI).

8a Irradiation Unit Electrical Power Systems

SER Section 8a, “Irradiation Facility Electrical Power Systems,” provides an evaluation of the 

preliminary design of SHINE’s IF electrical power systems as presented in SHINE PSAR 

Section 8a2, “Irradiation Unit Electrical Power Systems,” within which SHINE describes the 

irradiation unit (IU) normal electrical power systems and emergency electrical power systems.

8a.1 Areas of Review

As described in SHINE PSAR Sections 8b.1, “Normal Electrical Power Systems,” and 8b.2, 

“Emergency Electrical Power Systems,” respectively, the SHINE facility has one common 

normal electrical power system and one common emergency electrical power system, which 

serve both the IF and the RPF. Therefore, the areas of review described below are applicable 

to both the SHINE IF and RPF.

The staff reviewed PSAR Chapter 8 against applicable regulatory requirements using regulatory 

guidance and standards to assess the sufficiency of the preliminary design of the SHINE facility 

electrical power systems. As part of this review, the staff evaluated descriptions and 

discussions of SHINE’s electrical power systems, with special attention to design and operating 

characteristics, unusual or novel design features, and principal safety considerations. The 

preliminary design of SHINE’s electrical power systems was evaluated to ensure the sufficiency 

of principal design criteria; design bases; and information relative to materials of construction, 

general arrangement, and approximate dimensions, sufficient to provide reasonable assurance 

that the final design will conform to the design bases. In addition, the staff reviewed SHINE’s 

identification and justification for the selection of those variables, conditions, or other items that 

are determined to be probable subjects of technical specifications for the facility, with special 

attention given to those items that may significantly influence the final design.

Areas of review for this section included normal and emergency electrical power systems. 

Within these review areas, the staff assessed the preliminary analysis of the normal electrical 

power systems to ensure the safe operation and shutdown of the SHINE IUs, including the 

response of the facility to interruptions of normal electrical service, the ability of the facility to be 

maintained in a safe condition with and without the availability of normal electrical service, the 

monitoring and control of routine releases, and the prevention of uncontrolled releases of 
Electrical Power Systems

8-2

radioactive material in the event that normal electrical power service is interrupted. The staff 

examined the ranges of power required, schematic diagrams, design and performance 

specifications, deviations from guidance and their justifications, and probable subjects for 

technical specifications.

The staff also assessed the preliminary design and analysis of the SHINE emergency electrical 

power systems, including the design and functions of the emergency electrical power systems 

and their support of related systems required for protecting the health and safety of the public. 

8a.2 Summary of Application

As stated above and described in SHINE PSAR Sections 8b.1 and 8b.2, the SHINE facility has 

one common normal electrical power system and one common emergency electrical power 

system, which serve both the IF and the RPF. Therefore, the summary provided below applies 

to both the IF and RPF.

The normal electrical power supply consists of 480-volts alternating current (VAC) offsite power 

service from the local utility, Alliant Energy, and an onsite commercial standby diesel generator 

(SDG). The normal power is used for normal operation and normal shutdown of the facility. 

The parts of the normal electrical power supply are described in detail in SHINE PSAR 

Sections 8a2.1.1, “SHINE Facility Off-site Power Service,” through 8a2.1.12, “SHINE Facility 

Irradiation Units.” SHINE PSAR Section 8a2.1.2, “SHINE Facility Power Distribution System,” 

provides a description of the distribution and outdoor lighting systems. The facility power 

distribution system voltages are 480Y/277 VAC and 208Y/277 VAC, 3-phase, 60 hertz (Hz). 

The SDG and the loads supported by the SDG are described in SHINE PSAR Sections 8a2.1.3, 

“SHINE Facility Standby Diesel Generator,” and 8a2.1.4, “SHINE Facility Loads Supported by 

SDG.” SHINE PSAR Section 8a2.1.5, “Power Distribution Equipment,” provides a description of 

the power distribution equipment in the facilities. The remaining subsections of SHINE PSAR 

Section 8a2.1 also cover distribution systems, motor control centers (MCCs), distribution 

panels, and other electrical components. The SHINE PSAR also provides a description of the 

grounding systems, lightning protection system, cathodic protection system, freeze protection, 

cable and raceway components, and raceway and cable routing.

SHINE PSAR Section 8a2.1 states the design basis of the normal electrical power system is to 

provide sufficient and reliable power to all systems and components requiring electrical power 

for normal operations and for safe shutdown of the facility. The normal electrical power system 

is not safety-related, but it supports safety-related systems during normal operations. During an 

event of loss of normal power, a safety-related, uninterruptible power supply system (UPSS) will 

provide power to the safety-related systems and components. 

SHINE PSAR Section 8a2.2 states the emergency electrical power is the temporary substitute 

of normal electric power in the event of a loss-of-offsite power (LOOP). Emergency electrical 

systems are designed to prevent damage to IUs and releases of radioactive material to the 

environment. While the IUs are designed for passive shutdown, if normal electrical service is 

interrupted, certain IU functions require emergency electrical power for maintaining the facility in 

a safe condition following shutdown. As described in SHINE PSAR Section 8a2.2, the 

emergency electrical power system consists of the UPSS and is designed to provide reliable 

power for the safety-related equipment required for facility instrumentation, control, monitoring, 

and other vital functions needed for shutdown of the SHINE facility. The UPSS contains a 

250-volts-direct current (VDC) battery subsystem, battery chargers, inverters, bypass voltage 

regulating transformers, distribution panels, and other distribution equipment necessary to 
Electrical Power Systems

8-3

maintain power to safety-related AC or DC loads. The UPSS will be expected to provide 

emergency power to safety-related loads for the duration necessary per the PSAR analysis. 

PSAR Section 8a2.2.3, “SHINE Facility Systems Served by the Class 1E UPSS,” provides the 

list of the SHINE facility systems served by the Class 1E UPSS. The systems specifically 

associated with the RPF that are served by the UPSS are the process vessel vent system 

(PVVS), the continuous air monitoring system (CAMS), and the criticality accident alarm system 

(CAAS). All other systems associated with the RPF are designed to fail safe in the event of a 

LOOP. 

8a.3 Regulatory Basis and Acceptance Criteria

As previously stated and described in SHINE PSAR Sections 8b.1 and 8b.2, the SHINE facility 

has one common normal electrical power system and one common emergency electrical power 

system, respectively. Therefore, the regulatory basis and acceptance criteria provided below 

apply to both the IF and RPF.

The staff reviewed SHINE PSAR Sections 8a2 and 8b against applicable regulatory 

requirements, using regulatory guidance and standards, to assess the sufficiency of the 

preliminary design and performance of SHINE’s electrical power systems for the issuance of a 

construction permit. In accordance with paragraph (a) of Title 10 of the Code of Federal 

Regulations (10 CFR) 50.35, “Issuance of Construction Permits,” a construction permit 

authorizing SHINE to proceed with construction may be issued once the following findings have 

been made:

(1) SHINE described the proposed design of the facility, including, but not limited to, the 

principal architectural and engineering criteria for the design, and has identified the 

major features or components incorporated therein for the protection of the health and 

safety of the public. 

(2) Such further technical or design information as may be required to complete the safety 

analysis, and which can reasonably be left for later consideration, will be supplied in 

the final safety analysis report (FSAR). 

(3) Safety features or components, if any, which require research and development have 

been described by SHINE and a research and development program will be conducted 

that is reasonably designed to resolve any safety questions associated with such 

features or components. 

(4) On the basis of the foregoing, there is reasonable assurance that: (i) such safety 

questions will be satisfactorily resolved at or before the latest date stated in the 

application for completion of construction of the proposed facility, and (ii) taking into 

consideration the site criteria contained in 10 CFR Part 100, the proposed facility can 

be constructed and operated at the proposed location without undue risk to the health 

and safety of the public.

With respect to the last of these findings, the staff notes that the requirements of 

10 CFR Part 100 are specific to nuclear power reactors, and therefore not applicable to the 

SHINE facility. However, the staff evaluated SHINE’s site specific conditions using site criteria 

similar to 10 CFR Part 100, by using the guidance in NUREG-1537. The staff’s review 

evaluated the geography and demography of the site; nearby industrial, transportation, and 

military facilities; site meteorology; site hydrology; and site geology, seismology, and 
Electrical Power Systems

8-4

geotechnical engineering to ensure that issuance of the construction permit will not be inimical 

to public health and safety.

The staff’s evaluation of the preliminary design of SHINE’s electrical power systems does not 

constitute approval of the safety of any design feature or specification. Such approval will be 

made following the evaluation of the final design of SHINE’s electrical power systems, as 

described in the FSAR as part of SHINE’s operating license application.

8a.3.1 Applicable Regulatory Requirements

The applicable regulatory requirements for the evaluation of SHINE’s electrical power systems 

are as follows:

10 CFR 50.34, “Contents of applications; technical information,” paragraph (a), 

“Preliminary safety analysis report.”

8a.3.2 Regulatory Guidance and Acceptance Criteria

In applying guidance and acceptance criteria, the staff used its judgment as to which 

acceptance criteria were relevant to SHINE’s proposed facility, as much of this guidance was 

originally developed for nuclear reactors. Given the similarities in SHINE’s proposed facility and 

non-power research reactors, the staff used established guidance documents and the 

Commission’s regulations to determine the acceptance criteria for demonstrating compliance 

with 10 CFR regulatory requirements. For example, the staff used: 

• NUREG-1537, Part 1, “Guidelines for Preparing and Reviewing Applications for the 

Licensing of Non-Power Reactors, Format and Content,” issued February 1996 

(Reference 4); 

• 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 (Reference 5); 

• “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 (Reference 6); and

• “Final Interim Staff Guidance [ISG] 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 (Reference 7).

As stated in the ISG Augmenting NUREG-1537, the staff determined that certain guidance 

originally developed for heterogeneous non-power research and test reactors is applicable to 

aqueous homogenous facilities and production facilities. SHINE used this guidance to inform 

the design of its facility and prepare its PSAR. The staff’s use of reactor-based guidance in its 

evaluation of the SHINE PSAR is consistent with the ISG Augmenting NUREG-1537.
Electrical Power Systems

8-5

As appropriate, additional guidance (e.g., NRC regulatory guides, Institute of Electrical and 

Electronics Engineers (IEEE) standards, American National Standards Institute/American 

Nuclear Society (ANSI/ANS) standards) has been used in the staff’s review of SHINE’s PSAR. 

The use of additional guidance is based on the technical judgment of the reviewer, as well as 

references in NUREG-1537, Parts 1 and 2; the ISG Augmenting NUREG-1537, Parts 1 and 2; 

and the SHINE PSAR. Additional guidance documents used to evaluate SHINE’s PSAR are 

provided as references in Appendix B of this SER.

8a.4 Review Procedures, Technical Evaluation, and Evaluation Findings

As described in SHINE PSAR Sections 8b.1 and 8b.2, the SHINE facility has one common 

normal electrical power system and one common emergency electrical power system that serve 

both the IF and the RPF. While the technical evaluation of these systems provided in this 

section is specific to the SHINE IF, the staff’s review considers the interface of these systems 

between the IF and RPF as part of a comprehensive technical evaluation.

The staff performed an evaluation of the technical information presented in SHINE PSAR 

Section 8a2, as supplemented by the applicant’s responses to RAIs, to assess the sufficiency of 

the preliminary design and performance of SHINE’s electrical power systems in the IF for the 

issuance of a construction permit, in accordance with 10 CFR 50.35(a). The sufficiency of the 

preliminary design and performance of the SHINE IU is determined by ensuring the design and 

performance meet applicable regulatory requirements, guidance, and acceptance criteria, as 

discussed in Section 8a.3, “Regulatory Basis and Acceptance Criteria,” of this SER. A summary 

of the technical evaluation is described in SER Section 8a.5, “Summary and Conclusion.”

For the purposes of issuing a construction permit, the preliminary design of the SHINE normal 

and emergency power systems may be adequately described at a functional or conceptual 

level. The staff evaluated the sufficiency of the preliminary design of the SHINE normal and 

emergency electrical power systems based on the applicant’s design methodology and ability to 

provide reasonable assurance that the final design will conform to the design bases with 

adequate margin for safety. As such, the staff’s evaluation of the preliminary design of SHINE’s 

electrical power systems does not constitute approval of the safety of any design feature or 

specification. Such approval will be made following the evaluation of the final design of SHINE’s 

electrical power systems, as described in the FSAR, as part of SHINE’s operating license 

application.

8a.4.1 Normal Electrical Power Systems

The staff evaluated the sufficiency of the preliminary design of SHINE’s normal electrical power 

systems, as described in SHINE PSAR Section 8a2.1, using the guidance and acceptance 

criteria from Section 8.1, “Normal Electrical Power Systems,” of NUREG-1537, Parts 1 and 2. 

The staff review included the off-site power service, power distribution system, standby diesel 

generator and supported loads, distribution equipment, facility grounding system, lightning 

protection system, cathodic protection system, freeze protection, and cable and raceway 

components and routing. 

Consistent with the review procedures in NUREG-1537, Part 2, Section 8.1, “Normal Electrical 

Power Systems,” the staff: (1) compared the design bases of the normal IU electrical systems 

with the requirements of IU systems and components that rely on electrical power, (2) confirmed 

that the design characteristics and components of the normal IU electrical system could provide 

the projected range of services, (3) analyzed possible malfunctions, accidents, and interruptions 
Electrical Power Systems

8-6

of electrical services to determine their effect on safe facility operation, and (4) determined if 

proposed redundancy of electrical circuits are sufficient to ensure safe IU operation and 

shutdown and to avoid uncontrolled release of radioactive material.

On the basis of its review, the staff has determined that the level of detail provided on SHINE’s 

normal electrical power systems demonstrates an adequate design basis for a preliminary 

design and satisfies the applicable acceptance criteria of NUREG-1537, Part 2, Section 8.1, 

allowing the staff to make the following relevant findings: (1) the design bases and functional 

characteristics of the normal electrical power systems will support all required loads, and (2) the 

design of the normal electrical power system provides that, in the event of the loss or 

interruption of electrical power, the facility can be safely shut down and maintained in a safe 

shutdown condition.

Therefore, the staff finds that the preliminary design of the SHINE normal electrical power 

systems in the IF, as described in SHINE PSAR Section 8a2.1, is sufficient and meets the 

applicable regulatory requirements and guidance for of the issuance of a construction permit in 

accordance with 10 CFR 50.35. Further technical or design information required to complete 

the safety analysis (e.g., the design and location of electrical wiring that prevents inadvertent 

electromagnetic interference between the electrical power service and safety-related 

instrumentation and control circuits) may reasonably be left for later consideration. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

8a.4.2 Emergency Electrical Power Systems

The staff evaluated the sufficiency of the preliminary design of SHINE’s emergency electrical 

power systems in the IF, as described in PSAR Section 8a2.2 and supplemented by a response 

to a RAI using the guidance and acceptance criteria from Section 8.2, “Emergency Electrical 

Power Systems,” of NUREG-1537, Parts 1 and 2.

Consistent with the review procedures of NUREG-1537, Part 2, Section 8.2, the staff compared 

the design bases of the emergency electrical power system with the requirements for 

emergency electrical power for IU systems and components requiring electrical power and 

compared the design and functional characteristics with the design bases to verify compatibility. 

The staff review included the Class 1E UPSS; 250-VDC, Class 1E battery subsystem; 

nonsafety-related loads, maintenance and testing; surveillance methods; seismic qualification; 

independence; single-failure criterion; safe shutdown of the IU; and monitoring systems on 

UPSS.

The staff noted that SHINE PSAR, Section 8a2.2.1, “Class 1E UPSS,” references SHINE PSAR 

Figure 8a2.2-1, “One-Line Diagram – Uninterruptible Electrical Power Supply System” 

(Reference 47), for UPSS components configuration. SHINE PSAR Section 8a2.1.11, 

“Raceway and Cable Routing,” states, in part, “Non-Class 1E circuits are electrically isolated 

from Class 1E circuits by isolation devices in accordance with IEEE 384 (IEEE, 2008).” 

SHINE PSAR, Figure 8a2.2-1 shows the Class 1E/non-Class 1E boundaries for UPSS 

Divisions A and B as horizontal dashed lines with arrows pointing upward toward what the 

annotation indicates is the non-Class 1E side. For both divisions, the drawing shows the 

Class 1E/non-Class 1E boundaries to be situated between the first load circuit breakers from 
Electrical Power Systems

8-7

the respective facility 480-VAC SDG bus supplying each division’s Class 1E battery charger and 

Class 1E 480V-208Y/120V voltage-regulating transformer and the respective input/supply circuit 

breakers for those battery chargers and voltage-regulating transformers.

Class 1E isolation devices are located and designed to function to isolate non-Class 1E circuits 

with sustained overloads or faults from otherwise unaffected Class 1E circuits powered from a 

common source to preserve the continuity of power to the otherwise unaffected Class 1E 

circuits. Because the SDG buses normally provide power to both Class 1E and non-Class 1E 

loads, then theoretically, all the non-Class 1E load circuit breakers from the SDG busses, or 

their respective local supply breakers, could be considered Class 1E isolation devices that must 

trip open to clear faults or sustained overloads on the non-Class1E loads to preserve continuity 

of power to the Class 1E loads.

However, based on the information provided in the SHINE PSAR, it was not clear which circuit 

breakers are considered Class 1E isolation devices. The staff must know which circuit breakers 

serve as Class 1E isolation devices, because even though they may be enclosed in the 

switchgear for non-Class 1E busses, and are considered physically part of the non-Class 1E 

portion of the electrical power distribution system, they must perform a Class 1E function, and 

therefore, be classified as Class 1E themselves.

Accordingly, in RAI 8a2.2-1 (Reference 14), the staff requested that the applicant provide 

additional information to further explain the design approach to Class 1E isolation and to 

designate which circuit breakers in the electrical power distribution systems for the SHINE 

facility are to serve as Class 1E isolation devices. Additionally, the staff requested that the 

applicant explain the bases for those designations, how the type of circuit breakers designated 

as Class 1E isolation devices will be reasonably assured of meeting the specifications for such 

devices consistent with IEEE Std. 384-2008, “IEEE Standard Criteria for Independence of Class 

1E Equipment and Circuits,” (IEEE 2008). This information is necessary to demonstrate the 

adequacy of the design basis of the SHINE emergency electrical power system and satisfy the 

acceptance criteria of NUREG-1537, Part 2, Section 8.2, which states, in part, that “[a]ny 

non-safety-related uses of an emergency electrical power system should not interfere with 

performance of its safety-related functions.”

In its response to RAI 8a2.2-1 (Reference 21), the applicant stated the following: 

The 480-VAC SDG buses shown on Figure 8a2.1-1 and Figure 8a2.2-1 of the 

PSAR are non-Class 1E buses. These buses provide the normal power supply 

to the Class 1E systems and are not designed to maintain continuity of power to 

the Class 1E systems upon a loss of off-site power (LOOP) or a fault on the 

buses. Therefore none of the circuit breakers on these buses are considered 

Class 1E isolation devices that must trip open to clear faults or sustained 

overloads on the non-Class 1E loads.

The Class 1E isolation devices are described in PSAR Section 8a2.2.2 and 

shown in PSAR Figure 8a2.2-1 as “Class 1E Battery Charger A,” “Voltage 

Regulating Xfmr Assembly A Class 1E,” “Class 1E Battery Charger B,” and 

“Voltage Regulating Xfmr Assembly B Class 1E.” These devices isolate the 

Class 1E 250 volts-direct current (VDC) and Class 1E 120 VAC UPSS busses 

from the non-Class 1E 480 VAC SDG busses.
Electrical Power Systems

8-8

The Class 1E battery chargers and voltage regulating transformers are Class 1E 

isolation devices that meet the requirements of Section 6.1.2.3 of IEEE 

Std. 384-2008 (IEEE 2008) by limiting the input current to an acceptable value 

under faulted conditions.

During detailed design, the Class 1E battery chargers and voltage regulating 

transformers are to be specified to include electrical isolation requirements in 

accordance with IEEE 384-2008. The suppliers of these devices are to submit 

test reports to demonstrate compliance with the electrical isolation requirements 

of IEEE 384-2008. An IMR [Issue Management Report] has been initiated to 

track receipt of these reports.

The staff finds that this response satisfies the acceptance criteria of NUREG-1537, Part 2, 

Section 8.2, and demonstrates an adequate design basis for a preliminary design. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

On the basis of its review, the staff has determined that the level of detail provided on SHINE’s 

emergency electrical power systems demonstrates an adequate design basis for a preliminary 

design and satisfies the applicable acceptance criteria of NUREG-1537, Part 2, Section 8.2, 

allowing the staff to make the following relevant findings: (1) the design bases and functional 

characteristics of the IU emergency electrical power systems are sufficient for the necessary 

range of safety-related services, (2) the design and operating characteristics of the source of 

emergency electrical power are basic and reliable, ensuring availability if needed, and (3) the 

design of the emergency electrical power system should not interfere with safe facility shutdown 

or lead to IU damage if the system malfunctions during normal IU operation.

Therefore, the staff finds that the preliminary design of the SHINE emergency electrical power 

systems in the IF, as described in SHINE PSAR Section 8a2.2 and supplemented by the 

applicant’s response to an RAI, is sufficient and meets the applicable regulatory requirements 

and guidance for of the issuance of a construction permit in accordance with 10 CFR 50.35. 

Further technical or design information required to complete the safety analysis (e.g., the 

adequacy of emergency electrical power system design features that ensure availability, 

including the mechanisms of startup, source of generator fuel, routing of wiring, and methods of 

isolation from normal services), may reasonably be left for later consideration. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

8a.4.3 Probable Subjects of Technical Specifications

As stated above and described in SHINE PSAR Sections 8b.1 and 8b.2, the SHINE facility has 

one common normal electrical power system and one common emergency electrical power 

system, which serve both the IF and the RPF. Therefore, the evaluation of probable subjects of 

technical specifications provided below applies to both the IF and RPF.

In accordance with 10 CFR 50.34(a)(5), the staff evaluated the sufficiency of the applicant’s 

identification and justification for the selection of those variables, conditions, or other items 

which are determined to be probable subjects of technical specifications for the SHINE electrical 

power systems, with special attention given to those items which may significantly influence the 

final design.
Electrical Power Systems

8-9

Section 8a2.1.14, “Technical Specifications,” of the SHINE PSAR states that “[t]here are no 

potential variables, conditions, or other items that will be probable subjects of a technical 

specification associated with the normal electrical power system.” Section 8a2.2.12, “Technical 

Specifications,” and Section 8b.3, “Radioisotope Production Facility Electrical Power Systems 

Technical Specifications,” indicate that probable subjects of technical specifications associated 

with the emergency electrical power system are provided in PSAR Chapter 14, “Technical

Specifications.” SHINE PSAR Section 14b.3.4, “Emergency Electrical Power,” states that the 

“power supply is listed as a [limiting condition for operation] pursuant to 10 CFR 50.36(c)(1).”

Based on the information provided in Sections 8a2.1.14, 8a2.2.12, 8b.3, and 14b.3.4 of the 

SHINE PSAR, the staff finds that the identification and justification of the power supply as a 

limiting condition for operation (LCO) for the SHINE emergency electrical power systems is 

sufficient and meets the applicable regulatory requirements for of the issuance of a construction 

permit in accordance with 10 CFR 50.35. A detailed evaluation of technical specifications, 

including LCOs and surveillance requirements, will be performed during the review of SHINE’s 

operating license application.

8a.5 Summary and Conclusions

The staff evaluated descriptions and discussions of SHINE’s electrical power systems in the IF, 

including probable subjects of technical specifications, as described in PSAR Section 8a2 and 

supplemented by the applicant’s responses to RAIs, and finds that the preliminary design of 

SHINE’s electrical power systems in the IF, including the principal design criteria; design bases; 

and information relative to materials of construction, general arrangement, and approximate 

dimensions: (1) provides reasonable assurance that the final design will conform to the design 

basis, and (2) meets all applicable regulatory requirements and acceptance criteria in or 

referenced in NUREG-1537. 

On the basis of these findings, the staff has made the following conclusions for of the issuance 

of a construction permit in accordance with 10 CFR 50.35:

(1) SHINE described the proposed design of electrical power systems in the IF, including, 

but not limited to, the principal architectural and engineering criteria for the design, and 

has identified the major features or components incorporated therein for the protection 

of the health and safety of the public.

(2) Further technical or design information required to complete the safety analysis of the 

electrical power systems in the IF may reasonably be left for later consideration the 

FSAR.

(3) There is reasonable assurance that, taking into consideration the site criteria contained 

in 10 CFR Part 100, the proposed facility can be constructed and operated at the 

proposed location without undue risk to the health and safety of the public.

8b Radioisotope Production Facility Electrical Power Systems

SER Section 8b, “Radioisotope Production Facility Electrical Power Systems,” provides an 

evaluation of the preliminary design of SHINE’s RPF electrical power systems as presented in 

SHINE PSAR Section 8b, “Radioisotope Production Facility Electrical Power Systems.”
Electrical Power Systems

8-10

8b.1 Areas of Review

As described in SHINE PSAR Sections 8b.1 and 8b.2, respectively, the SHINE facility has one 

common normal electrical power system and one common emergency electrical power system, 

which serve both the IF and the RPF. Therefore, the areas of review described in SER Section 

8a.1, “Areas of Review,” are applicable to both the SHINE IF and RPF.

8b.2 Summary of Application

As stated above and described in SHINE PSAR Sections 8b.1 and 8b.2, the SHINE facility has 

one common normal electrical power system and one common emergency electrical power 

system, which serve both the IF and the RPF. Therefore, the summary of these systems 

provided in SER Section 8a.2, “Summary of Application,” is applicable to both the SHINE IF and 

RPF.

8b.3 Regulatory Basis and Acceptance Criteria

As previously stated and described in SHINE PSAR Sections 8b.1 and 8b.2, the SHINE facility 

has one common normal electrical power system and one common emergency electrical power 

system, respectively. Therefore, the regulatory basis and acceptance criteria provided in SER 

Section 8a.3, “Regulatory Basis and Acceptance Criteria,” applies to both the IF and RPF.

8b.4 Review Procedures, Technical Evaluation, and Evaluation Findings

As described in SHINE PSAR Sections 8b.1 and 8b.2, the SHINE facility has one common 

normal electrical power system and one common emergency electrical power system that serve 

both the IF and the RPF. While the technical evaluation of these systems provided in this 

section is specific to the SHINE IF, the staff’s review considers the interface of these systems 

between the IF and RPF as part of a comprehensive technical evaluation. The staff notes that 

PSAR Section 8b has no unique content. The staff evaluated the content of PSAR Section 8a2 

as it pertains to the preliminary design of functions and equipment necessary for RPF electrical 

power loads.

The staff performed an evaluation of the technical information presented in SHINE PSAR 

Section 8a2, as supplemented by the applicant’s responses to RAIs, to assess the sufficiency of 

the preliminary design and performance of SHINE’s electrical power systems in the RPF for of 

the issuance of a construction permit, in accordance with 10 CFR 50.35(a). The sufficiency of 

the preliminary design and performance of the SHINE IU is determined by ensuring the design 

and performance meet applicable regulatory requirements, guidance, and acceptance criteria, 

as discussed in Section 8a.3, “Regulatory Basis and Acceptance Criteria,” of this SER. A 

summary of the technical evaluation is described in SER Section 8b.5, “Evaluation Findings and 

Conclusion.”

For the purposes of issuing a construction permit, the preliminary design of the SHINE normal 

and emergency power systems may be adequately described at a functional or conceptual 

level. The staff evaluated the sufficiency of the preliminary design of the SHINE normal and 

emergency electrical power systems based on the applicant’s design methodology and ability to 

provide reasonable assurance that the final design will conform to the design bases with 

adequate margin for safety. As such, the staff’s evaluation of the preliminary design of SHINE’s 

electrical power systems does not constitute approval of the safety of any design feature or 

specification. Such approval will be made following the evaluation of the final design of SHINE’s 
Electrical Power Systems

8-11

electrical power systems, as described in the FSAR, as part of SHINE’s operating license 

application.

8b.4.1 Normal Electrical Power Systems

The staff evaluated the sufficiency of the preliminary design of SHINE’s normal electrical power 

systems in the RPF, as described in SHINE PSAR Section 8a2.1, using the guidance and 

acceptance criteria from Section 8.1 of NUREG-1537, Parts 1 and 2. The staff reviewing 

included the off-site power service; power distribution system; standby diesel generator and 

supported loads; distribution equipment; facility grounding system; lightning protection system; 

cathodic protection system; freeze protection; and cable and raceway components and routing.

Consistent with the review procedures of NUREG-1537, Part 2, Section 8.1, the staff:

(1) Compared the design basis of the normal electrical systems in the RPF with the 

requirements discussed in other chapters of the PSAR, specifically Sections 4b, 

“Radioisotope Production Facility Description;” 5b, “Radioisotope Production Facility 

Cooling Systems;” 7b, “Radioisotope Production Facility Instrument & Control System;” 

9b, “Radioisotope Production Facility Auxiliary Systems;” and 13b, “Radioisotope 

Production Facility Accident Analyses;” 

(2) Confirmed that the design characteristics and components of the RPF normal electrical 

systems could provide the projected range of services; 

(3) Analyzed possible malfunctions, accidents, and interruptions of electrical services to 

determine their effect on the safe RPF operation and shutdown; and 

(4) Determined that the proposed redundancy of electrical circuits is sufficient to ensure 

safe RPF operation and shutdown and to avoid uncontrolled release of radioactive 

material.

The staff reviewed SHINE PSAR Section 4b to verify that the design and functional 

characteristics of the RPF are commensurate with the design basis. PSAR Tables 4b.3-1, “Mo 

Extraction and Purification System Interfaces;” 4b.4-2, “System Interfaces - Uranyl Nitrate 

Preparation;” 4b.4-3, “System Interfaces - Uranium Extraction;” and 4b.4-4, “System 

Interfaces - Thermal Denitration;” provide the system interfaces between the normal electrical 

power system and the processes within the RPF.

The staff reviewed SHINE PSAR Section 5b, “Radioisotope Production Facility Cooling 

Systems,” to verify the information on normal electrical power systems related to the RPF for 

consistency with the information provided in Section 8b. The radioisotope process facility 

cooling system (RPCS) provides cooling to the RPF. PSAR Section 5a2.3.10, “RPCS Other 

Users,” and Table 5a2.3-3, “RPCS Interfaces,” describe the processes within the RPF that 

require cooling water. SHINE PSAR Table 5a2.3-3 describes the interface between the RPCS 

and the normal electrical power system.

The staff reviewed SHINE PSAR Section 7b, “Radioisotope Production Facility Instrument and 

Control System,” to verify compliance with the electrical wiring to prevent inadvertent 

electromagnetic interference between the electrical power system and the safety-related 

instrumentation and control circuits. Based on NRC Regulatory Guide 1.180, Revision 1, 

“Guidelines for Evaluating Electromagnetic and Radio-Frequency Interference in Safety Related 
Electrical Power Systems

8-12

Instrumentation and Control Systems” (Reference 48), the staff finds that the preliminary design 

and location of the electrical wiring will prevent inadvertent electromagnetic interference 

between the electrical power system and the safety-related instrumentation and control circuits. 

As discussed in SER Section 8a.4.1, a more detailed evaluation of this information will occur 

during the review of SHINE’s FSAR.

Additionally, the staff evaluated the design criteria for instrumentation and control systems in the 

RPF to ensure the proper electrical standards are used in the systems. SHINE PSAR 

Table 7b.2-1, “Design Criteria for the RPF Instrumentation and Control System,” provides the 

electrical codes used for the design of the RPF instrumentation and control system.

The staff reviewed SHINE PSAR Section 9b, “Radioisotope Production Facility Auxiliary 

Systems,” to verify the design basis of the RPF auxiliary systems. The auxiliary systems that 

interface with the normal electrical power system are: the PVVS, the noble gas removal system 

(NGRS), the radioactive liquid waste evaporation and immobilization system (RLWE) 

equipment, the radioactive liquid waste storage (RLWS), and the radioactive drain system 

(RDS).

The staff reviewed PSAR Section 13b.2, “Analyses of Accidents with Radiological 

Consequences,” to analyze any possible malfunction, accidents, and interruption of electrical 

services to determine their effect on safe facility operation on safe shutdown. The PSAR 

describes two accidents that could end up with radiological consequences; the release of 

inventory stored in the NGRS storage tanks (considered maximum hypothetical accident (MHA) 

in the RPF), and fire in the RPF due to an electrical equipment failure. Ducts and electrical 

cable penetrations will be sealed to limit the release of radioactive materials in an MHA event. 

In addition, to prevent the event of a fire in the RPF, SHINE will separate power and control 

cables for redundant trains and electrical cables will be qualified to IEEE Std. 1202, “IEEE 

Standard for Flame-Propagation Testing of Wire and Cable” (Reference 51), to ensure limited 

combustibility and limit the potential for fire ignition, growth, and spread.

The staff reviewed PSAR Section 8a2.1, “Normal Electrical Power Systems,” to verify that the 

content of the PSAR meets the applicable criteria described in Chapter 8 of NUREG-1537. 

Normal electrical power systems at the RPF are designated for safe operations and shutdown of 

the facility. The proposed RPF is designated for fail-safe passive shutdown in the event of a 

LOOP. The normal electrical power systems consist of the off-site power system, PSAR 

Section 8a2.1.1, and onsite normal power systems, PSAR Sections 8a2.1.2 through 8a2.1.12, 

including the SDG, PSAR Section 8a2.1.3.

PSAR Section 8a2.1.1 describes the off-site power service. The SHINE PSAR provides a 

description of the substation. The system consists of a 12 kilovolts (kV) single, independent 

off-site circuit that feeds two utility owned 12kV - 480Y/277 VAC 3-phase transformers at 

2000 kilovolt ampere (kVA) each. The loads connected to each transformer will be 

approximately 1500 kVA. A description of the loads that will be connected in each transformer 

is provided in PSAR Table 8a2.1-1, “Standby Diesel Generator Load List.”

PSAR Section 8a2.1.3, “SHINE Facility Standby Diesel Generator,” provides a description of the 

SDG that will supply power to selected loads in the event of a LOOP. SHINE stated that the 

availability of the SDG is not required for any of the safety functions in the SHINE facility.

The staff reviewed the cable and raceway components, as described in SHINE PSAR 

Section 8a2.1.10, “Cable and Raceway Components,” and the raceway and cable routing, as 
Electrical Power Systems

8-13

described in SHINE PSAR Section 8a2.1.11, “Raceway and Cable Routing,” using the National 

Fire Protection Association (NFPA) 70, National Electric Code (NEC) (Reference 49), as well as 

local codes for the design, installation, and separation of the cable raceway components. 

SHINE proposes to separate safety-related and nonsafety-related cables and raceway 

consistent with IEEE Std. 384 (Reference 50). The applicant also stated that the design will be 

consistent with the guidance in Regulatory Guide 1.180, Revision 1 (Reference 48), with the 

intention of preventing inadvertent electromagnetic interference between the electrical power 

system and safety-related instrumentation and control circuits in the final design. A more 

detailed evaluation of this information will occur during the review of SHINE’s FSAR to ensure 

the design is consistent with the guidance.

On the basis of its review, the staff has determined that the level of detail provided on SHINE’s 

normal electrical power systems in the RPF demonstrates an adequate design basis for a 

preliminary design and satisfies the applicable acceptance criteria of NUREG-1537, Part 2, 

Section 8.1, allowing the staff to make the following relevant findings: (1) the design bases and 

functional characteristics of the normal electrical power systems will support all required loads 

and (2) the design of the normal electrical power system provides that, in the event of the loss 

or interruption of electrical power, the facility can be safely shut down and maintained in a safe 

shutdown condition.

Therefore, the staff finds that the preliminary design of the SHINE normal electrical power 

systems in the RPF, as described in SHINE PSAR Section 8a2.1, is sufficient and meets the 

applicable regulatory requirements and guidance for of the issuance of a construction permit in 

accordance with 10 CFR 50.35. Further technical or design information required to complete 

the safety analysis (e.g., the design and location of electrical wiring that prevents inadvertent 

electromagnetic interference between the electrical power service and safety-related 

instrumentation and control circuits) may reasonably be left for later consideration. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

8b.4.2 Emergency Electrical Power Systems

The staff evaluated the sufficiency of the preliminary design of SHINE’s emergency electrical 

power systems in the RPF, as described in SHINE PSAR Section 8a2.2 and supplemented by a 

response to a RAI, in part, by reviewing the Class 1E UPSS; 250–VDC, Class 1E, battery 

subsystem; nonsafety-related loads, maintenance and testing; surveillance methods; seismic 

qualification; independence; single-failure criterion; and monitoring systems on the UPSS; using 

the guidance and acceptance criteria from Section 8.2 of NUREG-1537, Parts 1 and 2.

Consistent with the review procedures of NUREG-1537, Part 2, Section 8.2, the staff reviewed: 

(1) the design bases of the emergency electrical power systems, (2) the design and operating 

characteristics of the UPSS and equipment using IEEE standards to verify independence and 

isolation of circuits, for single failure criteria, and for seismic qualification of the equipment, and 

(3) the design of the emergency electrical power system.
Electrical Power Systems

8-14

On the basis of its review, the staff has determined that the level of detail provided on SHINE’s 

emergency electrical power systems demonstrates an adequate design basis for a preliminary 

design and satisfies the applicable acceptance criteria of NUREG-1537, Part 2, Section 8.2, 

allowing the staff to make the following relevant findings: 

(1) The design bases and functional characteristics of the RPF emergency electrical 

power systems are sufficient to provide the necessary range of safety-related services.

(2) The design and operating characteristics of the source of emergency electrical power 

are basic and reliable, ensuring availability if needed.

(3) The design of the emergency electrical power system should not interfere with safe 

facility shutdown or lead to RPF damage if the system malfunctions during normal RPF 

operation.

Therefore, the staff finds that the preliminary design of the SHINE emergency electrical power 

systems in the RPF, as described in SHINE PSAR Section 8a2.2 and supplemented by the 

applicant’s response to an RAI, is sufficient and meets the applicable regulatory requirements 

and guidance for of the issuance of a construction permit in accordance with 10 CFR 50.35. 

Further technical or design information required to complete the safety analysis (e.g., hydrogen 

generation rates) may reasonably be left for later consideration. The staff will confirm that the 

final design conforms to this design basis during the evaluation of SHINE’s FSAR.

8b.4.3 Probable Subjects of Technical Specifications

As stated above and described in SHINE PSAR Sections 8b.1 and 8b.2, the SHINE facility has 

one common normal electrical power system and one common emergency electrical power 

system, which serve both the IF and the RPF. Therefore, the evaluation of probable subjects of 

technical specifications provided in SER Section 8a.4.3, “Probable Subjects of Technical 

Specifications,” applies to both the IF and RPF.

8b.5 Evaluation Findings and Conclusions

The staff evaluated descriptions and discussions of SHINE’s electrical power systems in the 

RPF, including probable subjects of technical specifications, as described in PSAR Section 8a2 

and 8b.3 and supplemented by the applicant’s responses to RAIs, and finds that the preliminary 

design of SHINE’s electrical power systems in the RPF, including the principal design criteria; 

design bases; and information relative to materials of construction, general arrangement, and 

approximate dimensions: (1) provides reasonable assurance that the final design will conform 

to the design basis, and (2) meets all applicable regulatory requirements and acceptance 

criteria in or referenced in NUREG-1537. 

On the basis of these findings, the staff has made the following conclusions for of the issuance 

of a construction permit in accordance with 10 CFR 50.35:

(1) SHINE described the proposed design of electrical power systems in the RPF, 

including, but not limited to, the principal architectural and engineering criteria for the 

design, and has identified the major features or components incorporated therein for 

the protection of the health and safety of the public.
Electrical Power Systems

8-15

(2) Further technical or design information required to complete the safety analysis of the 

electrical power systems in the RPF may reasonably be left for later consideration the 

FSAR.

(3) There is reasonable assurance that, taking into consideration the site criteria contained 

in 10 CFR Part 100, the proposed facility can be constructed and operated at the 

proposed location without undue risk to the health and safety of the public.

9-1

AUXILIARY SYSTEMS

The preliminary design description of the auxiliary systems in the PSAR focuses on those 

structures, systems, components, and associated equipment that constitute the auxiliary safety 

systems and includes the overall design bases, system classifications, functional requirements, 

and system architecture. The auxiliary systems are designed for operation of the SHINE 

Medical Technologies, Inc. (SHINE or the applicant), irradiation facility (IF) and radioisotope 

production facility (RPF).

This chapter of the SHINE construction permit safety evaluation report (SER) describes the 

review and evaluation by the U.S. Nuclear Regulatory Commission (NRC) staff (the staff) of the 

preliminary design of the SHINE auxiliary systems as presented in Chapter 9, “Auxiliary 

Systems,” of the SHINE Preliminary Safety Analysis Report (PSAR), and supplemented by the 

applicant’s responses to requests for additional information (RAIs).

9a Irradiation Facility Auxiliary Systems

SER Section 9a, “Irradiation Facility Auxiliary Systems,” provides an evaluation of the 

preliminary design of SHINE’s IF auxiliary systems as presented in SHINE PSAR Section 9a2, 

“Irradiation Facility Auxiliary Systems.” 

9a.1 Areas of Review

The staff reviewed SHINE PSAR Section 9a2 against applicable regulatory requirements using 

regulatory guidance and standards to assess the sufficiency of the preliminary design and 

performance of SHINE’s irradiation facility auxiliary systems. As part of this review, the staff 

evaluated descriptions and discussions of SHINE’s auxiliary systems, with special attention to 

design and operating characteristics, unusual or novel design features, and principal safety 

considerations. The preliminary design of SHINE’s auxiliary systems was evaluated to ensure 

the sufficiency of principal design criteria; design bases; and information relative to materials of 

construction, general arrangement, and approximate dimensions, sufficient to provide 

reasonable assurance that the final design will conform to the design basis. In addition, the staff 

reviewed SHINE’s identification and justification for the selection of those variables, conditions, 

or other items which are determined to be probable subjects of technical specifications for the 

facility, with special attention given to those items which may significantly influence the final 

design. The following sections of the SER describe the areas reviewed.

Section 9a.4.1, “Heating, Ventilation, and Air Conditioning Systems,” provides an evaluation of 

SHINE’s radiologically controlled area and non-radiological area ventilation systems. Within 

these review areas, the staff assessed the characteristics and functions of the systems, the 

sources of radioactive materials that could become airborne during the full range of operation, 

and the way the systems are designed to affect the distribution and concentration of those 

materials, the features of the systems designed to limit exposures of personnel to radiation in 

the restricted area as a result of the full range of facility operation, the features of the HVAC 

system and associated facility structure designed to prevent inadvertent or uncontrolled release 

of airborne radioactive material to areas outside the radiologically controlled area (RCA) and to 

the unrestricted environment.
Auxiliary Systems

9-2

Section 9a.4.2, “Handling and Storage of Target Solution,” provides an evaluation of SHINE’s 

program for handling and storage of special nuclear material (SNM) and byproducts within the 

target solution and within the irradiation facility. Within this review area, the staff assessed the 

equipment, systems, methods, and administrative procedures for receipt of uranium, the 

systems and methods for movement, physical control, and storage of target solution within the 

facility, including analyses to prevent criticality.

Section 9a.4.3, “Fire Protection Systems and Programs,” provides an evaluation of SHINE’s fire 

protection system. Within this review area, the staff assessed the potential causes and 

consequences of fires at the facility, the fire protection plans and protective equipment used to 

limit the consequences of a fire, including defense in depth in the event of escalation of a fire, 

the passive designs or protective barriers planned to limit fire consequences, including features 

of the facility that could affect a safe facility shutdown or release radioactive material in the 

event of a continuing fire, the source of facility fire protection brigades and their training and the 

summary of the more detailed discussions of these personnel and offsite fire protection forces in 

the facility emergency plan, and compliance with local and national fire and building codes 

applicable to fire protection.

Section 9a.4.4, “Communication Systems,” provides an evaluation of SHINE’s communication 

systems between essential areas of the SHINE facility, as well as locations remote to the 

facility. Within this review area, the staff assessed the methods of communication between all 

necessary locations during the full range of facility operations and during emergencies.

Section 9a.4.5, “Possession and Use of Byproduct, Source, and Special Nuclear Material,” 

provides an evaluation of SHINE’s auxiliary systems within the IF that normally interact with 

byproduct, source, and SNM. Within this review area, the staff assessed the types and 

quantities of radionuclides authorized, the general types of processing, or packaging for 

shipments, the provisions for controlling and disposing of radioactive wastes, including special 

drains for liquids and chemicals, and air exhaust hoods for airborne materials, and the 

provisions for radiation protection, including shielding materials and radiation survey methods. 

The applicant has deferred submittal of Section 9a.4.6, “Cover Gas Control in Closed Primary 

Coolant Systems,” which will be provided and will be reviewed in the FSAR. 

Section 9a.4.7, “Other Auxiliary Systems,” provides an evaluation of SHINE’s other auxiliary 

systems in the IF that are not described in other chapters of SHINE PSAR. Within this review 

area, the staff assessed the systems description, including drawings and specifications of 

principal components and any special materials, operational analysis and safety function, and 

instrumentation and control requirements not described in SHINE PSAR Chapter 7, “Instrument 

and Control Systems.”

9a.2 Summary of Application

Section 9a2.1, “Heating, Ventilation, and Air Conditioning Systems,” of SHINE’s PSAR 

describes the radiologically controlled area (RCA) and non-radiological area ventilation systems. 

The heating, ventilation, and air conditioning (HVAC) systems provide ventilation to three areas 

in the radiologically controlled area (RCA) called RVZ1 (i.e., RCA ventilation zone 1), RVZ2, and 

RVZ3. RVZ1 includes the irradiation unit (IU) cells and the hot cells. RVZ2 includes operating 

areas, workrooms, and fume hoods. RVZ3 includes areas where contamination is not expected 

to occur under normal operating conditions. Thus, RVZ1 encompasses those areas with the 

highest potential for contamination with RVZ2 and RVZ3 encompassing areas of lesser potential 
Auxiliary Systems

9-3

contamination (RVZ3 being the least). Therefore, RVZ3 is maintained at a higher pressure than 

RVZ2, which is maintained at a higher pressure than RVZ1 so that airflow is toward areas of 

increasing contamination potential.

The HVAC system also provides ventilation to the non-RCA called FVZ4 (facility ventilation 

zone 4). 

The facility chilled water supply and distribution system (FCHS), is a closed-loop air-cooled 

chilled water system that provides cooling water to the cooling coils that are located outside the 

RCA boundary. The FCHS also supplies water to the radioisotope production facility cooling 

system (RPCS) heat exchangers.

The facility heating water system (FHWS) provides heated water (via a gas-fired boiler) to the 

RCA and non-RCA of the SHINE facility.

Testing of the HVAC systems will be done as appropriate. Technical specifications are 

discussed in PSAR Chapter 14, “Technical Specifications.”

Section 9a2.2, “Handling and Storage of Target Solution,” of SHINE PSAR describes the 

handling and storage of SNM and byproducts in the target solution within the IF. The 

preparation of the target solution is located outside of the IU cell. The piping used for transfer of 

the target solution to the IF cell includes penetrations of the cell through redundant sets of 

isolation valves. Target solution must meet the chemical property requirements discussed in 

PSAR Section 4a2.2.1 before it is transferred from the target solution hold tank to the target 

solution vessel. If the target solution is not within the required chemical specifications, 

operators make appropriate adjustments while the target solution is being prepared in the 

Target Solution Preparation System (TSPS). The storage and process tanks in the TSPS use 

double-contingency, criticality-safe controls. 

Section 9a2.3, “Fire Protection Systems and Programs,” of SHINE PSAR provides a description 

of the facility fire protection system (FFPS), which includes systems for early detection and 

notification of a fire, and provides the capability to extinguish fires in any SHINE facility area, to 

protect SHINE facility personnel and limit fire damage. The SHINE fire hazards analysis (FHA) 

is discussed in SHINE PSAR Section 9a2.3.4, “Fire Hazards Analysis.” SHINE Fire Protection 

Training Plan and Emergency Plan will be submitted with the SHINE FSAR. Technical 

specifications are discussed in SHINE PSAR Chapter 14.

Section 9a2.4, “Communication Systems,” of SHINE PSAR provides a description of the 

communication systems, which includes a normal communication system with paging, alarming, 

and party-line-type voice communications. A private exchange line, which is powered 

separately from the normal communications system, serves as a backup to the normal 

communications system. The communication system also includes a sound-powered phone 

system which operates without a power source and is not affected by loss of power to the 

facility, and a radio system operating on ultra-high frequency bands. The applicant stated that 

the SHINE FSAR will provide more detailed descriptions of the communication systems, 

including drawings and specifications. The applicant also stated that the systems will be tested, 

as appropriate, and that it has been determined that the communications systems will not be in 

the technical specifications for the SHINE facility.

Section 9a2.5, “Possession and Use of Byproduct, Source, and Special Nuclear Material,” of 

SHINE PSAR provides a description of the byproduct, source, and SNM used in the IF. The 
Auxiliary Systems

9-4

review of the TPS is provided in SER Section 9a2.7, “Other Auxiliary Systems.” The byproduct 

material present in the TSPS and the Target Solution Vessel (TSV) are fission products. The 

review of the TSPS is provided in SER Section 9b.2.5, “Possession and Use of Byproduct, 

Source, and Special Nuclear Material,” and the review of the TSV is provided in SER 

Section 4a2.4, “Target Solution Vessel and Light Water Pool.” Neutron multiplication occurs 

within the neutron multiplier, which is a part of the Subcritical Assembly System (SCAS). The 

review of the SCAS in provided in SER Chapter 4. The SNM is the small amount of plutonium 

(Pu) produced during the neutron irradiation.

In SHINE PSAR Section 9a2.6, “Cover Gas Control in Closed Primary Coolant Systems,” the 

applicant stated that the primary closed loop cooling system (PCLS) is a closed loop cooling 

system that provides cooling to the TSV. Details for the cover gas control will be provided in the 

SHINE FSAR.

Section 9a2.7, “Other Auxiliary Systems,” of SHINE PSAR describes the Tritium Purification 

System (TPS), whose purpose is to remove impurities in the tritium, after it has been used in the 

neutron driver assembly system (NDAS) so that it can be reused. The TPS process steps are 

conducted inside of two gloveboxes that are sized such that one glovebox can accommodate 

the process needs of all eight NDAS neutron drivers. Since tritium is hydrogen and is 

flammable, the glovebox is operated in a nitrogen environment during TPS operation. The 

glovebox atmosphere is cooled via a water chiller system. The glovebox atmosphere is 

monitored/alarmed for oxygen. The area around the gloveboxes and the TPS piping is 

monitored/alarmed for tritium to detect any leaks. In addition, TPS piping is maintained at 

sub-atmospheric pressures.

SHINE PSAR Section 9b contains a summary description of the RPF auxiliary systems. It 

describes the design of the RPF auxiliary systems and the processes employed within it, 

includes the principal safety considerations that were factored into the RPF design, 

construction, and operation.

9a.3 Regulatory Basis and Acceptance Criteria

The regulatory basis and acceptance criteria provided below apply to both the IF and the RPF.

The staff reviewed SHINE PSAR Sections 9a.2 and 9b against applicable regulatory 

requirements, using regulatory guidance and standards, to assess the sufficiency of the 

preliminary design and performance of SHINE’s auxiliary systems for the issuance of a 

construction permit. In accordance with paragraph (a) of Title 10 of the Code of Federal 

Regulations (10 CFR) 50.35, “Issuance of Construction Permits,” a construction permit 

authorizing SHINE to proceed with construction may be issued once the following findings have 

been made:

(1) SHINE has described the proposed design of the facility, including, but not limited to, 

the principal architectural and engineering criteria for the design, and has identified the 

major features or components incorporated therein for the protection of the health and 

safety of the public. 

(2) Such further technical or design information as may be required to complete the safety 

analysis, and which can reasonably be left for later consideration, will be supplied in 

the final safety analysis report (FSAR). 
Auxiliary Systems

9-5

(3) Safety features or components, if any, which require research and development have 

been described by SHINE and a research and development program will be conducted 

that is reasonably designed to resolve any safety questions associated with such 

features or components. 

(4) On the basis of the foregoing, there is reasonable assurance that: (i) such safety 

questions will be satisfactorily resolved at or before the latest date stated in the 

application for completion of construction of the proposed facility, and (ii) taking into 

consideration the site criteria contained in 10 CFR Part 100, the proposed facility can 

be constructed and operated at the proposed location without undue risk to the health 

and safety of the public.

With respect to the last of these findings, the staff notes that the requirements of 

10 CFR Part 100 are specific to nuclear power reactors, and therefore not applicable to the 

SHINE facility. However, the staff evaluated SHINE’s site specific conditions using site criteria 

similar to 10 CFR Part 100, by using the guidance in NUREG-1537. The staff’s review 

evaluated the geography and demography of the site; nearby industrial, transportation, and 

military facilities; site meteorology; site hydrology; and site geology, seismology, and 

geotechnical engineering to ensure that issuance of the construction permit will not be inimical 

to public health and safety.

The staff’s evaluation of the preliminary design of SHINE’s auxiliary systems does not constitute 

approval of the safety of any design feature or specification. Such approval will be made 

following the evaluation of the final design of SHINE’s auxiliary systems as described in the 

FSAR as part of SHINE’s operating license application

9a.3.1 Applicable Regulatory Requirements

The applicable regulatory requirements for the evaluation of SHINE’s auxiliary systems are as 

follows:

• 10 CFR 50.34, “Contents of applications; technical information,” paragraph (a), 

“Preliminary safety analysis report.”

• 10 CFR 50.40, "Common Standards.”

9a.3.2 Regulatory Guidance and Acceptance Criteria

In applying guidance and acceptance criteria, the staff used its judgment as to which 

acceptance criteria were relevant to SHINE’s proposed facility, as much of this guidance was 

originally developed for nuclear reactors. Given the similarities in SHINE’s proposed facility and 

non-power research reactors, the staff used established guidance documents and the 

Commission’s regulations to determine the acceptance criteria for demonstrating compliance 

with 10 CFR regulatory requirements. For example, the staff used: 

• NUREG-1537, Part 1, “Guidelines for Preparing and Reviewing Applications for the 

Licensing of Non-Power Reactors, Format and Content,” issued February 1996 

(Reference 4).
Auxiliary Systems

9-6

• 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 (Reference 5).

• “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 (Reference 6).

• “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 (Reference 7).

As stated in the ISG Augmenting NUREG-1537, the staff determined that certain guidance 

originally developed for heterogeneous non-power research and test reactors is applicable to 

aqueous homogenous facilities and production facilities. SHINE used this guidance to inform 

the design of its facility and prepare its PSAR. The staff’s use of reactor-based guidance in its 

evaluation of the SHINE PSAR is consistent with the ISG Augmenting NUREG-1537.

As appropriate, additional guidance (e.g., NRC regulatory guides, Institute of Electrical and 

Electronics Engineers (IEEE) standards, American National Standards Institute/American 

Nuclear Society (ANSI/ANS) standards) has been used in the staff’s review of SHINE’s PSAR. 

The use of additional guidance is based on the technical judgment of the reviewer, as well as 

references in NUREG-1537, Parts 1 and 2; the ISG Augmenting NUREG-1537, Parts 1 and 2; 

and the SHINE PSAR. Additional guidance documents used to evaluate SHINE’s PSAR are 

provided as references in Appendix B of this SER.

9a.4 Review Procedures, Technical Evaluation, and Evaluation Findings

The staff performed an evaluation of the technical information presented in SHINE PSAR 

Section 9a2, as supplemented by the applicant’s responses to RAIs, to assess the sufficiency of 

the preliminary design and performance of SHINE’s auxiliary systems in the IF for the issuance 

of a construction permit, in accordance with 10 CFR 50.35(a). The sufficiency of the preliminary 

design and performance of SHINE’s auxiliary systems is determined by ensuring the design and 

performance meet applicable regulatory requirements, guidance, and acceptance criteria, as 

discussed in Section 9a.3, “Regulatory Basis and Acceptance Criteria,” of this SER. A summary 

of the technical evaluations is described in SER Section 9a.5, “Summary and Conclusions.”

For the purposes of issuing a construction permit, the preliminary design of the SHINE auxiliary 

systems may be adequately described at a functional or conceptual level. The staff evaluated 

the sufficiency of the preliminary design of the SHINE auxiliary systems based on the 

applicant’s design methodology and ability to provide reasonable assurance that the final design 

will conform to the design bases with adequate margin for safety. As such, the staff’s evaluation 

of the preliminary design of SHINE’s auxiliary systems does not constitute approval of the safety 

of any design feature or specification. Such approval will be made following the evaluation of 

the final design of SHINE’s auxiliary systems, as described in the FSAR, as part of SHINE’s 

operating license application.
Auxiliary Systems

9-7

9a.4.1 Heating, Ventilation, and Air Conditioning Systems

The staff evaluated the sufficiency of the preliminary design of SHINE’s heating, ventilation, and 

air conditioning (HVAC) systems, as described in SHINE PSAR Section 9a2.1, by reviewing the 

radiologically controlled and non-radiological areas ventilation system, the chilled water supply 

and distribution system, the heating water system, using the guidance and acceptance criteria 

from Section 9.1, “Heating, Ventilation, and Air Conditioning Systems,” of NUREG-1537, Parts 1 

and 2.

Consistent with the review procedures in NUREG-1537, Part 2, Section 9.1, the staff evaluated 

SHINE’s HVAC system for all operations and functions during the full range of facility 

operations. The staff compared the design bases with requirements from other chapters of the 

PSAR, including Chapters 4, “Irradiation Unit And Radioisotope Production Facility Description,” 

Chapter 6, “Engineered Safety Features,” Chapter 7, “Instrumentation and Control Systems,” 

Chapter 11, “Radiation Protection Program and Waste Management,” and Chapter 13, 

“Accident Analysis,” to determine whether the HVAC system designs agree with the acceptance 

criteria for the full range of facility operations. 

NUREG-1537, Part 2, Section 9.1, “Heating, Ventilation, and Air Conditioning Systems,” 

Acceptance Criteria, states, in part: “The design and operating features of the system should 

ensure that no uncontrolled release of airborne radioactive material to the unrestricted 

environment could occur.” 

SHINE PSAR, Section 9a2.1.1, “Radiologically Controlled Area Ventilation System,” states that 

RCA Zone 2 Supply Air supplies air to RCA Ventilation System Zone 2 and RCA Ventilation 

System Zone 3, but there is no mention of where RCA Ventilation System Zone 1 gets its supply 

air from. SHINE PSAR, Figure 9a2.1-2, has an arrow after the supply fans that states: “Supply 

Air Flows to Additional Rooms, but provides no clarification as to what rooms/areas receive the 

air. PSAR, Figure 9a2.1-1 has an arrow going into the irradiation unit cell and an arrow going 

into the hot cell. Both arrows have the following statement: “Transfer Air from Zone 2.” It is not 

clear if the supply to the irradiation unit and hot cells is via dedicated ductwork or from ambient 

air drawn from the room. The staff also noted that while SHINE Section 9a2.1.2, 

“Non-Radiological Area Ventilation System,” discusses the Facility Ventilation Zone 4 (FVZ4) 

system and further states that this is a non-radiological controlled area ventilation system, 

additional information, on the potential for contamination in this area, was needed to determine 

the adequacy of the FVZ4 ventilation system.

Therefore, in RAI 9a2.1-1 (Reference 14), the staff requested that PSAR Section 9a2, and the 

flow diagrams (Figures 9a2.1-1 and 9a2.1-2) be revised to clarify the ambiguities with respect to 

the operation of RCA Ventilation System Zone 1 (RVZ1) and RCA Ventilation System Zone 2 

(RVZ2), and provide an additional flow diagram for RCA Ventilation System Zone 3 (RVZ3). 

In response to RAI 9a2.1-1 (Reference 21), the applicant provided some additional details of the 

operation of RVZ1, RVZ2, and RVZ3.

The staff noted that while Section 9a2.1.2, “Non-Radiological Area Ventilation System,” 

discusses the Facility Ventilation Zone 4 (FVZ4) system and further states that this is a 

non-radiological controlled area ventilation system, the staff needed additional information on 

the potential for contamination in this area to determine the adequacy of the FVZ4 ventilation. 

Therefore, in RAI 9a2.1-2 (Reference 14), the staff requested additional information on the 
Auxiliary Systems

9-8

FVZ4 ventilation system, including information on where the system exhausts, whether there 

are any radiation detectors on the exhaust, and a FVZ4 flow diagram.

In RAI 9a2.1-3 (Reference 17), the staff delineated how the applicant’s response to RAI 9a2.1-2 

does not supply sufficient information about the configuration and function of RVZ1, RVZ2, and 

RVZ3. In response (Reference 26), the applicant provided the necessary information with 

descriptions of each system, a revised flow chart of the RCA HVAC showing the 

interrelationship between RVZ1, RVZ2, and RVZ3 and a marked-up general arrangement 

showing the areas ventilated by RVZ1, RVZ2, RVZ3, and FVZ4.

Included in the response was the pressure relationship between the four HVAC zones and 

ambient atmospheric pressure as follows:

PRVZ1 < PRVZ2 < PRVZ3 < Pambient < PFVZ4

The applicant also clarified that RVZ3 consisted of only the airlocks, provided a list of the 

airlocks, and provided the location (including labeling) of the airlocks on the marked-up general 

arrangement, which clearly showed that the airlocks are within the Seismic Category I RCA 

boundary. Finally, the applicant stated that the airlocks do not have fans to maintain their air 

pressure, but rather airflow control valves that are supplied by the RVZ2 air-handling units with 

the RVZ3 exhausted air being transferred into the RVZ2 ventilated area. The applicant further 

clarified their function by stating that the airlocks are the tertiary confinement zone for the RCA.

While the applicant’s responses to the above RAIs are sufficient, there are still the issues of 

control room habitability and RVZ3 safety classification as discussed in SER Section 3.5. The 

staff will confirm that the final design conforms to the design basis of NUREG-1537, Part 2, 

Section 9.1, during the evaluation of SHINE’s FSAR.

The staff finds that the level of detail provided on SHINE’s heating, ventilation, and air 

conditioning systems demonstrates an adequate design basis for a preliminary design and 

satisfies the applicable acceptance criteria of NUREG-1537, Part 2, Section 9.2, allowing the 

staff to make the following relevant findings: 

• A review of the design bases and functional and safety characteristics of the HVAC 

systems shows that the proposed systems are adequate to control the release of 

airborne radioactive effluents during the full range of facility operations in compliance 

with the regulations.

• The applicant has discussed all sources of radioactive material that could become 

airborne in the facility from a full range of facility operations. The analyses demonstrate 

that the radioactive material is controlled by the HVAC system and could not 

inadvertently escape from the RCA. They show that the distributions and concentrations 

of the airborne radionuclides in the facility are limited by operation of the HVAC system 

so that during the full range of facility operations, no potential occupational exposures 

would exceed the design bases derived in Chapter 11 of SHINE PSAR.

• The applicant has considered the height and flow rate of the stack that exhausts facility 

air to the unrestricted environment for the design-basis dose rates derived in Chapter 11 

of SHINE PSAR for the maximum exposed personnel in the unrestricted environment.
Auxiliary Systems

9-9

• The HVAC system is an integral part of a confinement system at the facility. The design 

of the confinement system and analysis of its operation ensure that it will function to limit 

normal airborne radioactive material to the extent analyzed in this chapter and 

Chapter 11 of SHINE PSAR. The potential radiation doses will not exceed the limits of 

10 CFR Part 20 and are consistent with the facility as low as is reasonably achievable 

(ALARA) program.

Therefore, the staff finds that the preliminary design of the SHINE heating, ventilation, and air 

conditioning systems, as described in SHINE PSAR Section 9a2.1, is sufficient and meets the 

applicable regulatory requirements and guidance for the issuance of a construction permit in 

accordance with 10 CFR 50.35 and 50.40. However, the staff is tracking SHINE’s responses to 

RAIs 9a2.1-1 through 9a2.1-3 (including Table 9a2.1-3-1, and Figures 9a2.1-2-1, 9a2.1-3-1, and 

9a2.1-3-2) as regulatory commitments in Appendix A of this SER and will confirm their

resolution in the SHINE FSAR. The staff will confirm that the final design conforms to this 

design basis during the evaluation of SHINE’s FSAR.

9a.4.2 Handling and Storage of Target Solution

The staff evaluated the sufficiency of the preliminary design of SHINE’s handling and storage of 

the target solution, as described in SHINE PSAR Section 9a2.2, by reviewing the preparation, 

storage and handling of the target solution, the equipment used for loading/unloading the TSV 

with target solution, and the storage of SNM, using the guidance and acceptance criteria from 

Section 9.2, “Handling and Storage of Reactor Fuel,” of NUREG-1537, Parts 1 and 2.

Consistent with the review procedures of NUREG-1537, Part 2, Section 9.2, the staff evaluated 

the systems and methods used to handle and store new and irradiated target solution, 

compared the design bases in this and other chapters of the PSAR (such as Chapters 4, 6, 11, 

and 13) with the requirements of 10 CFR 50.34(a) and 10 CFR Part 20, and focused on the 

design features that control radiation and prevent criticality.

On the basis of its review, the staff has determined that the level of detail provided on SHINE’s 

handling and storage of the target solution demonstrates an adequate design basis for a 

preliminary design and satisfies the applicable acceptance criteria of NUREG-1537, Part 2, 

Section 9.2, allowing the staff to make the following relevant findings: 

(1) As evaluated in SER Section 6b3, the analyses show that fuel storage features will 

ensure that criticality cannot occur. Plans to implement the applicable requirements of 

10 CFR 70.24 for criticality monitoring are acceptable.

(2) Tanks, pumps, and procedures for inserting and removing target solution from the 

TSVs are specially designed to avoid loss or damage to target solution. 

(3) As evaluated in SER Chapter 11, methods for assessing irradiated fuel radioactivity 

and potential exposure rates are adequate to avoid overexposure of the staff. 

Methods for shielding and storing irradiated fuel give reasonable assurance that 

potential personnel doses will not exceed the regulatory limits of 10 CFR Part 20 and 

are consistent with the facility ALARA program.

Therefore, the staff finds that the preliminary design of the SHINE handling and storage of the 

target solution in the IF, as described in SHINE PSAR Section 9a2.2, is sufficient and meets the 

applicable regulatory requirements and guidance for the issuance of a construction permit in 
Auxiliary Systems

9-10

accordance with 10 CFR 50.35 and 50.40. Further technical or design information required to 

complete the safety analysis may reasonably be left for later consideration. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR and that technical specifications will contain limitations on storage conditions necessary 

to ensure sub-criticality and to administratively and physically control the target solution.

9a.4.3 Fire Protection Systems and Programs

The staff evaluated the sufficiency of the preliminary design of SHINE’s fire protection systems 

and programs, as described in SHINE PSAR Section 9a2.3, in part, by reviewing the design 

bases, components of the system, and the fire hazard analysis, using the guidance and 

acceptance criteria from Section 9.3, “Fire Protection Systems and Programs,” of NUREG-1537, 

Parts 1 and 2.

Consistent with the review procedures of NUREG-1537, Part 2, Section 9.3, the staff evaluated 

the discussions of potential fires; provisions for early detection, including during those times

when areas are not occupied; methods for isolating, suppressing, and extinguishing fires; 

passive features designed into the facility to limit fire consequences; response organization 

training and availability to fight fires as detailed in the emergency plan; designs of facility 

systems that can ensure safe facility shutdown in the event of fire; and potential radiological 

consequences to the public, the staff, and the environment if firefighting efforts are 

unsuccessful.

The Fire Protection Training Plan and the Emergency Plan will be reviewed when the SHINE 

FSAR is submitted.

As part of its evaluation, the staff issued RAIs to the applicant. The RAIs and applicant’s 

responses are summarized below.

In RAI 9a2.3-1 (Reference 14), the staff requested that the applicant identify which fire detection 

and suppression systems are necessary to prevent or mitigate high or intermediate 

consequence accidents and describe and commit to applying management measures that will 

assure that these systems and components are constructed, procured, installed, and tested to 

ensure that they will be available and reliable to perform their intended functions when needed.

In response to RAI 9a2.3-1 (Reference 21), the applicant stated that there are no fire detection 

or suppression systems that are credited with prevention and/or mitigation of potential accident 

scenarios. The applicant went on to state that the fire protection program will be designed, 

constructed, and maintained consistent with the applicable National Fire Protection Association 

(NFPA) standards. Finally, the applicant stated that the fire protection program will be included 

in the Administrative Controls section of the SHINE technical specifications, and that the fire 

protection system components are subject to the SHINE Quality Assurance Program, as 

described in the SHINE Quality Assurance Program Description (QAPD). The staff finds that 

this response satisfies the acceptance criteria of NUREG-1537, Part 2, Section 9.3. The staff 

will confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

Because of the configuration of Fire Area 6 (a long “L” shaped corridor), in RAI 9a2.3-2 

(Reference 14), the staff requested additional information on personnel evacuation.
Auxiliary Systems

9-11

In response to RAI 9a2.3-2 (Reference 21), the applicant responded that the corridor has fire 

detection and water suppression and the egress distances meet the requirements of the 

International Building Code (IBC) and the Life Safety Code (LSC). The staff finds that this 

response satisfies the acceptance criteria of NUREG-1537, Part 2, Section 9.3. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

The staff noted that Fire Areas (FA) 1 and 3 utilize gaseous fire suppression systems, which 

could result in asphyxiation during a release. Therefore, in RAI 9a2.3-3 (Reference 14), the 

staff requested that the applicant provide clarification on how potential asphyxiation during a 

release of the gaseous suppression systems has been addressed.

In response to RAI 9a2.3-3 (Reference 21), the applicant responded that automatic gaseous fire 

suppression systems will be equipped with a pre-discharge alarm system and a discharge delay 

to permit personnel egress. In addition, warning signs will be affixed in appropriate locations for 

areas protected by an automatic gaseous fire suppression system. The staff finds that this 

response satisfies the acceptance criteria of NUREG-1537, Part 2, Section 9.3. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

The staff noted that in radiation areas, the smoke detection capability of ionization detectors 

could be adversely affected and that photoelectric smoke detector capability can be affected in 

areas of dust/particulates. Therefore, in RAI 9a2.3-4 (Reference 14), the staff requested 

clarification on the basis of choosing detectors, and what maintenance program will be used to 

assure that the detectors function properly.

In response to RAI 9a2.3-4 (Reference 21), the applicant stated that fire detection systems are 

designed, installed, located, inspected, tested, and maintained consistent with NFPA 72, 

“National Fire Alarm and Signaling Code.” The applicant further stated that it would ensure that 

appropriate fire detection equipment is placed in radiation areas and areas of dust/particulates. 

The staff finds that this response satisfies the acceptance criteria of NUREG-1537, Part 2, 

Section 9.3. The staff will confirm that the final design conforms to this design basis during the 

evaluation of SHINE’s FSAR.

The staff noted that the neutron moderation capability of firefighting foam is not discussed in the 

SHINE PSAR. Therefore, in RAI 9a2.3-5 (Reference 14), the staff requested information on the 

moderation capabilities of firefighting foams because local fire departments may use foam as 

part of their firefighting repertoire. The staff also requested information on foam, if any, that can 

or will be used in the facility and what training is proposed for the fire brigade and for offsite fire 

departments that may provide assistance.

In response to RAI 9a2.3-5 (Reference 21), the applicant responded that there are no 

firefighting foam systems within the RCA in the current design of the facility. The applicant 

added that discussions have been initiated with Rock County Emergency Management. The 

Rock County 911 Communications Center will have a response information binder specific to 

emergency response at the SHINE facility. The applicant also stated that it will ensure that the 

response information binder specific to emergency response at the SHINE facility does not 

allow off-site fire support organizations to use firefighting foam within the SHINE RCA, and will 

ensure that the Rock County 911 Communications Center’s SHINE-specific response 

information binder provides specific guidance on the use of firefighting foam at the SHINE 

facility. Finally, the applicant stated that periodic training will be provided to both SHINE fire 
Auxiliary Systems

9-12

brigade members and off-site fire support organizations regarding permitted manual fire 

suppression techniques at the SHINE facility.

The staff noted that the Boiler Room (FA-17), which has a natural gas pipeline supplying the 

boiler, is adjacent (i.e., shares a common wall) to the Fire Brigade/Hazmat Room (FA-16) that 

contains the Fire Zone Panels. Therefore, in RAI 9a2.3-6 (Reference 14), the staff requested 

additional information on the potential for a fire in the Boiler Room and asked the applicant to 

provide, in its response, the effects of the pipeline gas combustible load (until the pipeline can 

be shut off outside the Boiler Room) on the FA-17 and on the rest of the building. 

In response to RAI 9a2.3-6 (Reference 21), the applicant responded that the walls, floors, and 

ceilings of the FA-17 boundary have a 3-hour fire resistive rating as required by a high 

combustible loading in the room and where an adjacent room contains equipment or systems 

from a different safety train. The 3-hour fire barrier provides adequate time for operators to 

manually isolate the natural gas supply, if required. The applicant further stated that the 

potential release of natural gas into FA-17 will be limited by the installation of safety controls, as 

required by Wisconsin Administrative Code Chapter SPS 341.

While the above response is sufficient for the issuance of a construction permit, at the operating 

license stage, the effects of the pipeline gas combustible load (until the pipeline can be shut off 

outside the boiler room) on the boiler room and adjacent fire areas needs to be discussed in the 

FSAR. The staff will confirm that the final design conforms to this design basis during the 

evaluation of SHINE’s FSAR.

The staff noted that SHINE PSAR Figure 9a2.3-1 indicates that there are fire zones inside of 

FA-1 and FA-2. However, the fire zones are not numbered. In RAI 9a2.3-7 (Reference 14), the 

staff requested information indicating whether the fire zones will be numbered, and whether the 

fire zone numbers will be unique. Additionally, the staff requested that the applicant provide 

information indicating whether the FHA will provide assessments of each fire zone.

In response to RAI 9a2.3-7 (Reference 21), the applicant stated that each fire zone will be 

uniquely numbered and as the detailed design is completed, the FHA will be revised and 

updated. Also, the final FHA will provide an assessment of each fire zone. 

On the basis of its review, the staff has determined that the level of detail provided on SHINE’s 

fire protection systems and programs demonstrates an adequate design basis for a preliminary 

design and satisfies the applicable acceptance criteria of NUREG-1537, Part 2, Section 9.2, 

allowing the staff to make the following relevant findings: (1) the fire protection plan for 

preventing fires ensures that the facility meets local and national fire and building codes, (2) the 

systems designed to detect and combat fires at the facility can function as described and limit 

damage and consequences at any time, (3) the potential radiological consequences of a fire will 

not prevent safe facility shutdown, and (4) any release of radioactive material as a result of fire 

would not cause radiation exposures that exceeded the requirements of 10 CFR Part 20.

Therefore, the staff finds that the preliminary design of the SHINE fire protection systems and 

programs, as described in SHINE PSAR Section 9a2.3, is sufficient and meets the applicable 

regulatory requirements and guidance for the issuance of a construction permit in accordance 

with 10 CFR 50.35 and 50.40. Further technical or design information required to complete the 

safety analysis may reasonably be left for later consideration. The staff will confirm that the final 

design conforms to this design basis during the evaluation of SHINE’s FSAR.
Auxiliary Systems

9-13

9a.4.4 Communication Systems

The staff evaluated the sufficiency of the preliminary design of SHINE’s communication 

systems, as described in SHINE PSAR Section 9a2.4, in part, by reviewing the on-site and 

off-site communication systems, using the guidance and acceptance criteria from Section 9.4, 

“Communication Systems” of NUREG-1537, Parts 1 and 2.

Consistent with the review procedures of NUREG-1537, Part 2, Section 9.4, the staff evaluated 

the design bases; system description; operational analysis and safety function; and required 

technical specifications and their bases, including testing and surveillance.

On the basis of its review, the staff has determined that the level of detail provided on SHINE’s 

communication systems demonstrates an adequate design basis for a preliminary design and 

satisfies the applicable acceptance criteria of NUREG-1537, Part 2, Section 9.4, allowing the 

staff to make the following relevant findings: (1) the facility communication systems are 

designed to provide two-way communication between all locations essential for safe facility 

operation, (2) the communication systems allow the operator on duty to communicate with 

supervisory and health physics personnel, and (3) the communication systems allow a 

facility-wide announcement of an emergency and have provisions for summoning emergency 

assistance from designated personnel. 

Therefore, the staff finds that the preliminary design of the SHINE communications systems, as 

described in SHINE PSAR Section 9a2.4, is sufficient and meets the applicable regulatory 

requirements and guidance for the issuance of a construction permit in accordance with 

10 CFR 50.35. Further technical or design information required to complete the safety analysis 

may reasonably be left for later consideration. The staff will confirm that the final design 

conforms to this design basis during the evaluation of SHINE’s FSAR.

9a.4.5 Possession and Use of Byproduct, Source, and Special Nuclear Material

The staff evaluated the sufficiency of the preliminary design of SHINE’s program for possession 

and use of byproduct, source, and special nuclear material in the IF, as described in SHINE 

PSAR Section 9a2.5, in part, by reviewing how byproduct materials, source material, and SNM 

are generated and processed, using the guidance and acceptance criteria from Section 9.5, 

“Possession and Use of Byproduct, Source, and Special Nuclear Material,” of NUREG-1537, 

Parts 1 and 2.

Consistent with the review procedures of NUREG-1537, Part 2, Section 9.5, the staff evaluated 

the design bases; system description; operational analysis and safety function; and required 

technical specifications and their bases, including testing and surveillance.

On the basis of its review, the staff has determined that the facility design with respect to the 

byproduct, source, and SNM used in the IF demonstrates an adequate design basis for a 

preliminary design and satisfies the applicable acceptance criteria of NUREG-1537, Part 2, 

Section 9.5, allowing the staff to make the following relevant findings: 

(1) The auxiliary facilities and systems are designed for the possession and use of 

byproduct materials produced by the facility. The design bases include limits on 

potential personnel exposures that are in compliance with 10 CFR Part 20 and are 

consistent with the facility ALARA program. 
Auxiliary Systems

9-14

(2) The applicant has described the authorized spaces for use of the material and, to 

ensure that radiation exposures are acceptably limited, the design features specify 

upper limits on source strengths of radionuclides authorized for possession or use in 

the facility under the 10 CFR Part 50 license.

(3) Design features provide reasonable assurance that uncontrolled release of radioactive 

material to the unrestricted environment will not occur.

Therefore, the staff finds that the preliminary design of the SHINE program for the possession 

and use of byproduct, source, and SNM in the IF, as described in SHINE PSAR Section 9a2.5, 

is sufficient and meets the applicable regulatory requirements and guidance for the issuance of 

a construction permit in accordance with 10 CFR 50.35. Further technical or design information

required to complete the safety analysis may reasonably be left for later consideration. The 

staff will confirm that the final design conforms to this design basis during the evaluation of 

SHINE’s FSAR.

9a.4.6 Cover Gas Control in Closed Primary Coolant Systems

The staff evaluated the sufficiency of SHINE’s description of cover gas control in the primary 

coolant systems as presented in SHINE PSAR Section 9a2.6, “Cover Gas Control in Closed 

Primary Coolant Systems,” using the guidance and acceptance criteria from Section 1.6, “Cover 

Gas Control in Closed Primary Coolant Systems,” of NUREG-1537, Parts 1 and 2.

As stated in SHINE PSAR Section 1.8, “The PCLS is a closed loop cooling system that provides 

cooling to the TSV. Details for the cover gas control in the PCLS cooling water tank 

(1-PCLS-01T) will be provided in the FSAR.”

The staff finds that information on SHINE PSAR Section 9a2.6 pertains to the operations of the 

SHINE facility, and specific details are not necessary for the issuance of a construction permit. 

Therefore, the staff has deferred a more detailed evaluation of this section until the receipt of an 

FSAR supporting an operating license application.

9a.4.7 Other Auxiliary Systems

As described in Section 9.a2.7 of SHINE’s PSAR, the Tritium Purification System (TPS) is the 

only other auxiliary system in the IF. The staff evaluated the sufficiency of the preliminary 

design of SHINE’s TPS, as described in SHINE PSAR Section 9a2.7, in part, by reviewing the 

TPS process, and off-normal and accident scenarios, using the guidance and acceptance 

criteria from Section 9.7, “Other Auxiliary Systems,” of NUREG-1537, Parts 1 and 2.

Consistent with the review procedures of NUREG-1537, Part 2, Section 9.7, the staff compared 

the design and functional descriptions of TPS with the design bases. In addition, the staff 

reviewed the discussion and analyses of the functions and potential malfunctions with respect to 

safe facility operation and shutdown, the effect on facility safety systems, and the potential for 

TPS to initiate or affect the uncontrolled release of radioactive material.

The applicant performed an analysis of the TPS and determined that the system design, 

function, and potential malfunctions would not result in an uncontrolled release of radioactivity. 

The TPS was reviewed as part of the development of the ISA for potential as design basis 

accidents (DBAs) or initiating events (IEs). The guidance in NUREG-1520, “Standard Review 

Plan for the Review of a License Application for a Fuel Cycle Facility,” Revision 1 
Auxiliary Systems

9-15

(Reference 60), and NUREG-1537, Part 1, was used in this evaluation. The results of this 

evaluation (TPS accident analysis) are discussed in PSAR Chapter 13. The staff evaluation of 

the TPS accident analysis is provided in SER Chapter 13. 

On the basis of its review, the staff has determined that the level of detail provided on SHINE’s 

other auxiliary system demonstrates an adequate design basis for a preliminary design and 

satisfies the applicable acceptance criteria of NUREG-1537, Part 2, Section 9.7, allowing the 

staff to make the following relevant findings: (1) the system has been designed to perform the 

functions required by the design bases, (2) the functions and potential malfunctions, that could 

affect facility operations or initiate uncontrolled release of radioactive material, have been 

considered in the design of the system, and (3) the technical specifications and their bases 

proposed in the PSAR give reasonable assurance that the system will be operable, as required 

by the design bases.

Therefore, the staff finds that the preliminary design of SHINE auxiliary systems, as described in 

SHINE PSAR Section 9a2.7, is sufficient and meets the applicable regulatory requirements and 

guidance for of the issuance of a construction permit in accordance with 10 CFR 50.35. Further 

technical or design information required to complete the safety analysis may reasonably be left 

for later consideration. The staff will confirm that the final design conforms to this design basis 

during the evaluation of SHINE’s FSAR.

9a.4.8 Probable Subjects of Technical Specifications

In accordance with 10 CFR 50.34(a)(5), the staff evaluated the sufficiency of the applicant’s 

identification and justification for the selection of those variables, conditions, or other items 

which are determined to be probable subjects of technical specifications for the SHINE IF 

auxiliary systems, with special attention given to those items which may significantly influence 

the final design.

SHINE PSAR Table 14a2-1, “SHINE Facility Proposed Parameters for Technical 

Specifications,” provides potential variables, conditions, or other items that will be the probable 

subjects of technical specifications. With respect to SHINE IF auxiliary systems, information is 

provided on: (1) heating, ventilation, and air conditioning systems, (2) fire protection system,

and (3) possession and use of byproduct, source, and special nuclear material. Additionally, in 

PSAR Section 14a2.6, SHINE lists its fire protection program as an administrative control that 

will be provided in the technical specifications.

In PSAR Section 9a2.4.3, “Technical Specifications,” SHINE states that there are no potential 

variables, conditions, or other items that will be probable subjects of a technical specification 

associated with the communication systems.

Based on the information provided in PSAR Sections 9a2.4.3 and 14a2.6, as well as Table 

14a2-1, the staff finds that the identification and justification of SHINE’s PSTS meets the 

applicable regulatory requirements for of the issuance of a construction permit in accordance 

with 10 CFR 50.35. A detailed evaluation of technical specifications, including LCOs and 

surveillance requirements, will be performed during the review of SHINE’s operating license 

application.
Auxiliary Systems

9-16

9a.5 Summary and Conclusion

The staff evaluated the descriptions and discussions of SHINE’s irradiation facility auxiliary 

systems, as described in SHINE PSAR Section 9a2 and supplemented by the applicant’s 

responses to RAIs, and finds that the preliminary design of SHINE’s IF auxiliary systems, 

including the principal design criteria, design bases, and information relative to materials of 

construction, general arrangements, provides reasonable assurance that the final design will 

conform to the design basis and meets all applicable regulatory requirements and acceptance 

criteria in or referenced in NUREG-1537. 

On the basis of these findings, the staff has made the following conclusions for the issuance of 

a construction permit in accordance with 10 CFR 50.35:

(1) SHINE has described the proposed design of the auxiliary systems, including, but not 

limited, the principal architectural and engineering criteria for the design, and has 

identified the major features or components incorporated therein for the protection of 

the health and safety of the public.

(2) Further technical or design information required to compete the safety analysis of the 

auxiliary systems may be reasonably left for later consideration in the FSAR.

(3) There is reasonable assurance that, taking into consideration the site criteria contained 

in 10 CFR Part 100, the proposed facility can be constructed and operated at the 

proposed location without undue risk to the health and safety of the public.

(4) There is reasonable assurance: (i) that the construction of the SHINE facility will not 

endanger the health and safety of the public, and (ii) that construction activities can be 

conducted in compliance with the Commission’s regulations.

(5) The issuance of a permit for the construction of the facility would not be inimical to the 

common defense and security or to the health and safety of the public.

9b Radioisotope Production Facility Auxiliary Systems

SER Section 9b, “Radioisotope Production Facility Auxiliary Systems,” provides an evaluation of 

the preliminary design of SHINE’s RPF auxiliary systems as presented in SHINE PSAR Section 

9b, “Radioisotope Production Facility Auxiliary Systems.” 

9b.1 Areas of Review

The staff reviewed SHINE PSAR Section 9b against applicable regulatory requirements using 

regulatory guidance and standards to assess the sufficiency of the preliminary design and 

performance of SHINE’s radioisotope production facility auxiliary systems. As part of this 

review, the staff evaluated descriptions and discussions of SHINE’s auxiliary systems, with 

special attention to design and operating characteristics, unusual or novel design features, and 

principal safety considerations. The preliminary design of SHINE’s auxiliary systems was 

evaluated to ensure the sufficiency of principal design criteria; design bases; and information 

relative to materials of construction, general arrangement, and approximate dimensions, 

sufficient to provide reasonable assurance that the final design will conform to the design basis. 

In addition, the staff reviewed SHINE’s identification and justification for the selection of those 

variables, conditions, or other items which are determined to be probable subjects of technical
Auxiliary Systems

9-17

specifications for the facility, with special attention given to those items which may significantly 

influence the final design. The following sections of the SER describe the areas reviewed.

Section 9b.4.1, “Heating, Ventilation, and Air Conditioning Systems,” states that the SHINE 

facility has one heating, ventilation, and air conditioning system which serve both the IF and the 

RPF. Therefore, the review and evaluation described in SER Section 9a.4.1 “Heating, 

Ventilation, and Air Conditioning,” is applicable to both the SHINE IF and RPF.

Section 9b.4.2, “Handling and Storage of Target Solution,” provides an evaluation of SHINE’s 

program for handling and storage of special nuclear material (SNM) and byproducts within the 

target solution and within the radioisotope production facility. Within this review area, the staff 

assessed the equipment, systems, methods, and administrative procedures for receipt of 

uranium, the systems and methods for movement, physical control, and storage of target 

solution within the facility, including analyses to prevent criticality.

Section 9b.4.3, “Fire Protection Systems and Programs,” states that the SHINE fire protection 

systems and programs serve both the IF and the RPF. Therefore, the review and evaluation 

described in SER Section 9a.4.3 “Fire Protection Systems and Programs,” is applicable to both 

the SHINE IF and RPF.

Section 9b.4.4, “Communication Systems,” states that the communication system is common to 

both the IF and the RPF. Therefore, the review and evaluation described in SER Section 9a.4.4 

“Communication Systems,” is applicable to both the SHINE IF and RPF.

Section 9b.4.5, “Possession and Use of Byproduct, Source, and Special Nuclear Material,” 

provides an evaluation of SHINE’s auxiliary systems within the RPF that normally interact with 

byproduct, source, and SNM. Within this review area, the staff assessed the types and 

quantities of radionuclides authorized, the rooms, spaces, equipment, and procedures to be 

used, the general types of uses, such as research and development, processing, or packaging 

for shipment, the provisions for controlling and disposing of radioactive wastes, including special 

drains for liquids and chemicals, and air exhaust hoods for airborne materials, the relationship 

between these auxiliary facility designs and the physical security and emergency plans, and 

required technical specifications and their bases, including testing and surveillance.

Section 9b.4.6, “Cover Gas Control in Closed Primary Coolant Systems,” provides an evaluation 

of SHINE’s systems within the RPF that handle radioactive gases from process vessels. Within 

this area, the staff assessed the design bases, system description, including drawings and 

specifications of principal components and any special materials, operational analysis and 

safety function, instrumentation and control requirements not described in SHINE PSAR 

Chapter 7, “Instrument and Control Systems,” and required technical specifications and their 

bases, including testing and surveillance.

Section 9b.4.7, “Other Auxiliary Systems,” provides an evaluation of SHINE’s other auxiliary 

systems in the RPF that are not described in other chapters of SHINE’s PSAR. Within this 

review area, the staff assessed the molybdenum isotope product packaging system and the 

radiologically controlled area material handling.

9b.2 Summary of Application

As discussed in SHINE PSAR Section 9b.1, “Heating, Ventilation, and Air Conditioning 

Systems,” the SHINE facility has one heating, ventilation, and air conditioning system that 
Auxiliary Systems

9-18

serves both the IF and the RPF. Therefore, the summary provided in SER Section 9a.2 is 

applicable to both the SHINE IF and RPF. 

SHINE PSAR Section 9b.2 discusses the handling and storage of the target solution while it is 

in the RPF. This section includes the target solution lifecycle, dissolution of uranium metal, 

target solution preparation, shipment and receipt of SNM, target solution preparation and 

handling equipment, storage of SNM, and criticality control.

As discussed in SHINE PSAR Section 9b.3, “Fire Protection Systems and Programs,” the 

SHINE facility has one fire protection system and program. Therefore, the summary provided in 

SER Section 9a.3 is applicable to both the SHINE IF and RPF.

As discussed in SHINE PSAR Section 9b.4, “Communication Systems,” the SHINE facility has a 

common communication system which serves both the IF and the RPF. Therefore, the 

summary provided in SER Section 9a.4 is applicable to both the SHINE IF and RPF. 

SHINE PSAR Section 9b.5, “Possession and Use of Byproduct, Source, and Special Nuclear 

Material,” describes the generation of byproduct material by the fission and irradiation of target 

solution in the TSV and the systems that process byproduct material in the RPF. The eight 

auxiliary systems that process byproduct material in the RPF are as follows:

• Target Solution Preparation System (TSPS).

• Radioactive Drain System (RDS).

• Aqueous Radioactive Liquid Waste Storage System (RLWS).

• Radioactive Liquid Waste Immobilization System (RLWE).

• Process Vessel Vent System (PVVS).

• Molybdenum Isotope Product Packaging System (MIPS).

• Solid Radioactive Waste Packaging (SRWP).

• Noble Gas Removal System (NGRS).

SHINE PSAR Section 9b.6, “Cover Gas Control in Closed Primary Coolant Systems,” discusses 

systems that handle radioactive gases from process vessels. These are the PVVS and the 

NGRS. The PVVS collects and treats the off-gases from process vessels in the SHINE facility. 

The PVVS collects off-gases from each vented vessel containing a significant quantity of 

radioactive material in the RPF, and receives noble gases from the NGRS after a period of 

decay. The PVVS consists of an acid gas scrubber loop and a blower to vent treated gases out 

of the RCA. The NGRS receives the cover gas from the target solution vessel off gas system 

(TOGS), which consists of eight separate vessels. This gas is primarily air, with small quantities 

of krypton, xenon, and iodine radioisotopes. The gases are compressed and stored in one of 

five noble gas decay tanks for at least 40 days. This allows the short-lived radioisotopes to 

largely decay. The stored gases can then be vented through the PVVS to the RCA ventilation 

zone 1 (RVZ1) system for monitored release through the stack.

SHINE PSAR Section 9b.7, “Other Auxiliary Systems,” describes the auxiliary systems in the 

RPF not captured in other chapters of the PSAR. These include the MIPS Packaging System 

(MIPS) and the Radiologically Control Area Material Handling (RMHS). The MIPS receives the 

purified Mo-99 (now called the “Mo-99 product”) from the molybdenum extraction and 

purification system (MEPS). Once the Mo-99 product is in the MIPS shielded supercells, it 

undergoes assay and quality control procedures. The final Mo-99 product is then placed in a 

Mo-99 product shipping container. The RMHS includes overhead cranes, fork trucks, hand 
Auxiliary Systems

9-19

trucks, carts, and master-slave manipulators that are used to move or manipulate radioactive 

material within the RCA.

9b.3 Regulatory Basis and Acceptance Criteria

The regulatory basis and acceptance criteria provided in SER Section 9a.3, “Regulatory Basis 

and Acceptance Criteria,” applies to the auxiliary systems in both the IF and RPF.

9b.4 Review Procedures, Technical Evaluation, and Evaluation Findings

The staff performed an evaluation of the technical information presented in SHINE PSAR 

Section 9b, as supplemented by the applicant’s responses to RAIs, to assess the sufficiency of 

the preliminary design and performance of SHINE’s auxiliary systems in the RPF for the 

issuance of a construction permit, in accordance with 10 CFR 50.35(a). The sufficiency of the 

preliminary design and performance of SHINE’s auxiliary systems is demonstrated by ensuring 

the applicable regulatory requirements, guidance, and acceptance criteria, as discussed in 

Section 9a.3, “Regulatory Basis and Acceptance Criteria,” of this SER are met. The results of 

this technical evaluation are summarized in SER Section 9b.5, “Summary and Conclusion.”

For the purposes of issuing a construction permit, the preliminary design of the SHINE auxiliary 

systems may be adequately described at a functional or conceptual level. The staff evaluated 

the sufficiency of the preliminary design of the SHINE auxiliary systems based on the 

applicant’s design methodology and ability to provide reasonable assurance that the final design 

will conform to the design bases with adequate margin for safety. As such, the staff’s evaluation 

of the preliminary design of SHINE’s auxiliary systems does not constitute approval of the safety 

of any design feature or specification. Such approval will be made following the evaluation of 

the final design of SHINE’s auxiliary systems, as described in the FSAR, as part of SHINE’s 

operating license application.

9b.4.1 Heating, Ventilation, and Air Conditioning Systems

As stated before, the review and evaluation described in SER Section 9a.4.1 “Heating, 

Ventilation, and Air Conditioning,” is applicable to both the SHINE IF and RPF.

9b.4.2 Handling and Storage of Target Solution

The staff evaluated the sufficiency of the preliminary design of SHINE’s handling and storage of 

the target solution, as described in SHINE PSAR Section 9b.2, by reviewing the preparation, 

storage and handling of the target solution, the equipment used for loading/unloading the TSV 

with target solution, systems, components, and methods for radiation shielding and for 

protecting irradiated target solution from damage during removal from the IF, movement within 

the RPF, and the storage of SNM, using the guidance and acceptance criteria from Section 9.2, 

“Handling and Storage of Reactor Fuel,” of NUREG-1537, Parts 1 and 2.

Consistent with the review procedures of NUREG-1537, Part 2, Section 9.2, the staff evaluated 

the systems and methods used to handle and store new and irradiated target solution, 

compared the design bases in this and other chapters of the PSAR (such as Chapters 4, 6, 11, 

and 13) to the requirements of 10 CFR 50.34(a) and 10 CFR Part 20, and focused on the 

design features that control radiation and prevent criticality.
Auxiliary Systems

9-20

On the basis of its review, the staff has determined that the level of detail provided on SHINE’s 

handling and storage of the target solution within the RPF demonstrates an adequate design 

basis for a preliminary design and satisfies the applicable acceptance criteria of NUREG-1537, 

Part 2, Section 9.2, allowing the staff to make the following relevant findings:

(1) As discussed in Section 6b.3 of this SER, the staff has determined that the design of 

systems, components, and methods for handling, moving, and storing target solution 

outside the IF will provide reasonable assurance that under normal and credible 

abnormal conditions, all nuclear processes will be subcritical, including use of an 

NRC-approved margin of sub-criticality for safety. 

(2) The systems, components, and methods for handling, moving, and storing target 

solution, including insertion and removal from the IF, are designed to prevent damage 

to the target solution.

(3) The design of systems, components, and methods for handling, moving, and storing 

target solution demonstrate that the facility staff and the public are protected from 

radiation and that radiation exposures do not exceed the requirements of 10 CFR 

Part 20 and are consistent with the facility ALARA program.

Therefore, the staff finds that the preliminary design of the SHINE handling and storage of the 

target solution in the RPF, as described in SHINE PSAR Section 9b.2, is sufficient and meets 

the applicable regulatory requirements and guidance for of the issuance of a construction permit 

in accordance with 10 CFR 50.35 and 50.40. Further technical or design information required to 

complete the safety analysis may reasonably be left for later consideration. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR and that technical specifications will contain limitations on storage conditions necessary 

to ensure sub-criticality and to administratively and physically control the target solution.

9b.4.3 Fire Protection Systems and Programs

As stated before, the review and evaluation described in SER Section 9a.4.3 “Fire Protection 

Systems and Programs,” is applicable to both the SHINE IF and RPF.

9b.4.4 Communication Systems

As stated before, the review and evaluation described in SER Section 9a.4.4 “Communication 

Systems,” is applicable to both the SHINE IF and RPF.

9b.4.5 Possession and Use of Byproduct, Source, and Special Nuclear Material

The staff evaluated the sufficiency of the preliminary design of SHINE’s program for possession 

and use of byproduct, source, and special nuclear material in the RPF, as described in SHINE 

PSAR Section 9b.5, by reviewing how byproduct materials, source material, and SNM are 

generated and processed; the types and quantities of radionuclides authorized; the rooms, 

spaces, equipment, and procedures to be used; the general types of uses, such as research 

and development, processing, or packaging for shipment; the provisions for controlling and 

disposing of radioactive wastes, including special drains for liquids and chemicals, and air 

exhaust hoods for airborne materials; the relationship between these auxiliary facility designs 

and the physical security and emergency plans, required technical specifications and their 

bases, including testing and surveillance, using the guidance and acceptance criteria from 
Auxiliary Systems

9-21

Section 9.5, “Possession and Use of Byproduct, Source, and Special Nuclear Material,” of 

NUREG-1537, Parts 1 and 2.

Consistent with the review procedures of NUREG-1537, Part 2, Section 9.5, the staff 

evaluated the design bases, system description, operational analysis and safety 

function, and required technical specifications and their bases, including testing and 

surveillance.

• The staff compared the design bases for the auxiliary systems that process byproduct 

material in the RPF with the commitments developed in other chapters of SHINE PSAR, 

especially Chapters 11, “Radiation Protection and Waste Management,” and 12, 

“Conduct of Operations,” and evaluated agreement with the acceptance criteria of 

NUREG-1537, Part 2, Section 9.5..

On the basis of its review, the staff has determined that the facility design with respect to the 

byproduct, source, and SNM that will be used in the RPF demonstrates an adequate design 

basis for a preliminary design and satisfies the applicable acceptance criteria of NUREG-1537, 

Part 2, Section 9.5, allowing the staff to make the following relevant findings: 

(1) The auxiliary facilities and systems are designed for the possession and use of 

byproduct materials produced by the facility. The design bases include limits on 

potential personnel exposures that are in compliance with 10 CFR Part 20 and are 

consistent with the facility ALARA program. 

(2) The design features provide reasonable assurance that uncontrolled release of 

radioactive material to the unrestricted environment will not occur.

Therefore, the staff finds that the preliminary design of the SHINE program for the possession 

and use of byproduct, source, and SNM in the RPF, as described in SHINE PSAR Section 9b.5, 

is sufficient and meets the applicable regulatory requirements and guidance for the issuance of 

a construction permit in accordance with 10 CFR 50.35. Further technical or design information 

required to complete the safety analysis may reasonably be left for later consideration. The 

staff will confirm that the final design conforms to this design basis during the evaluation of 

SHINE’s FSAR.

9b.4.6 Cover Gas Control in Closed Primary Coolant Systems

SHINE PSAR Section 9b.6, “Cover Gas in Closed Primary Coolant Systems,” states that there 

are no primary coolant systems in the RPF and thus, this section of the PSAR discusses 

systems that handle radioactive gases from process vessels. These systems are the Process 

Vessel Vent System (PVVS) and the Noble Gas Removal System (NGRS). The PVVS collects 

and treats the off-gases from process vessels in the SHINE facility. The PVVS also collects 

off-gases from each vented vessel containing a significant quantity of radioactive material in the 

RPF, and receives noble gases from the NGRS after a period of decay. The NGRS receives 

the cover gas from the target solution vessel off gas system (TOGS). The staff evaluated the 

sufficiency of the preliminary design of SHINE’s cover gas control systems as described in 

SHINE PSAR Section 9b.6, by reviewing the (PVVS) and the NGRS, using the guidance and 

acceptance criteria from Section 9.6, “Cover Gas Control in Closed Primary Coolant Systems,” 

of NUREG-1537, Parts 1 and 2.
Auxiliary Systems

9-22

Consistent with the review procedures of NUREG-1537, Part 2, Section 9.6, the staff evaluated 

the cover gas control systems to ensure that:

• The design and functional description conforms to the design bases.

• The design, functions, and potential malfunctions of NGRS should not cause accidents 

to the facility or uncontrolled release of radioactivity.

• In the event radioactive material is released by the operation of NGRS, potential 

radiation exposures should not exceed the limits of 10 CFR Part 20 and should be 

consistent with the facility ALARA program.

On the basis of its review, the staff has determined that the level of detail provided on SHINE’s 

cover gas control systems satisfies the applicable acceptance criteria of NUREG-1537, Part 2, 

Section 9.6, allowing the staff to make the following relevant findings:

(1) The PVVS and NGRS are designed to capture and treat the expected off-gases at 

their anticipated concentrations of constituents under normal and accident conditions, 

and that the design-basis pressures can be maintained.

 

(2) Processing, storing, and recombining of radiolytic gases, as well as safe disposal of 

spent scrubber solutions, HEPA filters, and charcoal filters, have been incorporated 

into the design to ensure the safety of the facility and personnel.

(3) The PVVS and NGRS have been designed to perform the functions required by the 

design bases.

(4) Functions and potential malfunctions that could affect facility operations have been 

considered in the design of the system. No analyzed functions or malfunctions could 

initiate a facility accident, prevent safe facility shutdown, or initiate uncontrolled release 

of radioactive material. 

Therefore, the staff finds that the preliminary design of the SHINE cover gas control system as 

described in SHINE PSAR Section 9b.6, is sufficient and meets the applicable regulatory 

requirements and guidance for the issuance of a construction permit in accordance with 

10 CFR 50.35 and 50.40. Further technical or design information required to complete the 

safety analysis may reasonably be left for later consideration. The staff will confirm that the final 

design conforms to this design basis during the evaluation of SHINE’s FSAR and that technical 

specifications will contain limitations on storage conditions necessary to ensure sub-criticality 

and to administratively and physically control the target solution.

9b.4.7 Other Auxiliary Systems

The staff evaluated the sufficiency of the preliminary design of SHINE’s other auxiliary systems 

in the RPF, as described in SHINE PSAR Section 9b.7, by reviewing the following systems, 
Auxiliary Systems

9-23

using the guidance and acceptance criteria from Section 9.7, “Other Auxiliary Systems,” of 

NUREG-1537, Parts 1 and 2:

• Molybdenum Isotope Product Packaging System (MIPS).

• RCA Material Handling System (RMHS).

• Radioactive Liquid Waste Evaporation and Immobilization System (RWLE).

• Aqueous Radioactive Liquid Waste Storage System (RLWS).

• Solid Radioactive Waste Packaging System (SWRP).

• Radioactive Drain System (RDS).

• Material Handling System (MHS).

• Facility Potable Water System (FPWS).

• Facility Instrument Air System (FIAS).

• Facility Compressed Air System (FCAS).

• Facility Breathing Air System (FBAS).

• Facility Inert Gas System (FIGS).

• Facility Roof Drain Systems (FRDS).

• Facility Sanitary Drains System (FSDS).

• Facility Acid Reagent Storage and Distribution System (FARS).

• Facility Alkaline Reagent Storage and Distribution System (FSRS).

• Facility Organic Reagent Storage and Distribution System (FORS).

• Organic Liquid Waste Storage and Export (OLWS).

• Off-Normal and Accident Scenarios.

Consistent with the review procedures of NUREG-1537, Part 2, Section 9.7, the staff compared 

the design and functional descriptions of other auxiliary systems with their design bases. In 

addition, the staff reviewed the discussion and analyses of the functions and potential 

malfunctions with respect to safe facility operation and shutdown, the effect on facility safety 

systems, and the potential for these auxiliary systems to initiate or affect the uncontrolled 

release of radioactive material.

As part of its evaluation, the staff issued RAIs to the applicant. The RAIs and the applicant’s 

responses are summarized below.

Due to the size and weight of the shields and equipment that need to be moved, and the 

inventory of tritium and uranium onsite, in RAI 9b.7-1 (Reference 14), the staff requested that 

the applicant provide additional assessments demonstrating the implementation of the 

requirements of ASME B30.2 and CMAA 70 to ensure that dropped, toppled, rolled or otherwise 

off-normal load events do not result in the loss of safety function or the release of radioactivity to 

the public. The applicant responded (Reference 21) that the guidance provided in 

NUREG-0612, “Control of Heavy Loads at Nuclear Power Plants: Resolution of Generic 

Technical Activity A-36” (Reference 78), would be utilized and that a heavy load will be defined 

as a load that, if dropped, may cause radiological consequences that challenge 10 CFR Part 20 

limits. In addition, the applicant stated that the heavy load limit, and the associated load drop 

analysis, will be determined during detailed design and provided in the FSAR. The staff finds 

that SHINE’s commitment to following the guidance in NUREG-0612 in final design is 

acceptable and will confirm that the final design conforms to this design basis during the 

evaluation of SHINE’s FSAR.

With respect to the consequences that may result from inadvertent criticality during materials 

handling, in RAI 9b.7-2 (Reference 14), the staff requested that the applicant provide additional 
Auxiliary Systems

9-24

details on how the equipment will be designed to prevent inadvertent criticality and provide an 

assessment of why technical specifications are not needed or describe preliminary plans for 

technical specification safety limits and surveillance requirements. The applicant responded 

(Reference 21) that safety evaluations will be performed for systems that handle fissile material 

within the facility. In addition, the design for these systems will comply with the requirements for 

criticality safety detailed in ANSI/ANS-8.7-1998 (Reference 64) and the PSAR. The applicant 

further stated that administrative controls and maintenance will be applied to these systems to 

ensure reliability and availability. In addition, the applicant stated that in the FSAR, safety limits 

that are applicable for material handling activities will be included in the Technical Specifications 

(TS) and Surveillance Requirements (SR) will be developed to ensure criticality control is 

maintained during material handling activities. 

On the basis of its review, the staff has determined that the level of detail provided on SHINE’s 

other auxiliary system demonstrates an adequate design basis for a preliminary design and 

satisfies the applicable acceptance criteria of NUREG-1537, Part 2, Section 9.7, allowing the 

staff to make the following relevant findings: (1) the system has been designed to perform the 

functions required by the design bases, (2) the functions and potential malfunctions, that could 

affect facility operations or initiate uncontrolled release of radioactive material, have been 

considered in the design of the system, and (3) the technical specifications and their bases 

proposed in the PSAR give reasonable assurance that the system will be operable, as required 

by the design bases.

Therefore, the staff finds that the preliminary design of SHINE auxiliary systems, as described in 

SHINE PSAR Section 9b.7, is sufficient and meets the applicable regulatory requirements and 

guidance for the issuance of a construction permit in accordance with 10 CFR 50.35. Further 

technical or design information required to complete the safety analysis may reasonably be left 

for later consideration. The staff will confirm that the final design conforms to this design basis 

during the evaluation of SHINE’s FSAR.

9b.4.8 Probable Subjects of Technical Specifications

In accordance with 10 CFR 50.34(a)(5), the staff evaluated the sufficiency of the applicant’s 

identification and justification for the selection of those variables, conditions, or other items 

which are determined to be probable subjects of technical specifications for the SHINE RPF 

auxiliary systems, with special attention given to those items which may significantly influence 

the final design. The evaluation of the technical specifications is provided in SER Chapter 14.

SHINE PSAR Table 14a2-1, “SHINE Facility Proposed Parameters for Technical 

Specifications,” provides potential variables, conditions, or other items that will be the probable 

subjects of technical specifications. With respect to SHINE RPF auxiliary systems, information 

is provided on (1) heating, ventilation, and air conditioning systems, and (2) possession and use 

of byproduct, source, and special nuclear material, and (3) the noble gas removal system.

In PSAR Section 9b.7, “Other Auxiliary Systems,” SHINE states that there are no potential 

variables, conditions, or other items that will be probable subjects of a technical specification 

associated with the communication systems.

Based on the information provided in PSAR Section 9b.7, as well as Table 14a2-1, the staff 

finds that the identification and justification of SHINE’s PSTS meets the applicable regulatory 

requirements for of the issuance of a construction permit in accordance with 10 CFR 50.35. A 
Auxiliary Systems

9-25

detailed evaluation of technical specifications, including LCOs and surveillance requirements,

will be performed during the review of SHINE’s operating license application.

9b.5 Summary and Conclusions

The staff evaluated the descriptions and discussions of SHINE’s radioisotope production facility 

auxiliary systems, as described in SHINE PSAR Section 9b and supplemented by the 

applicant’s responses to RAIs, and finds that the preliminary design of SHINE’s RPF auxiliary 

systems, including the principal design criteria, design bases, and information relative to 

materials of construction, general arrangements, provides reasonable assurance that the final 

design will conform to the design basis and meets all applicable regulatory requirements and 

acceptance criteria in or referenced in NUREG-1537. 

On the basis of these findings, the staff has made the following conclusions for the issuance of 

a construction permit in accordance with 10 CFR 50.35 and 50.40:

(1) SHINE has described the proposed design of the auxiliary systems, including, but not 

limited, the principal architectural and engineering criteria for the design, and has 

identified the major features or components incorporated therein for the protection of 

the health and safety of the public.

(2) Further technical or design information required to compete the safety analysis of the

auxiliary systems may be reasonably left for later consideration in the FSAR.

(3) There is reasonable assurance that, taking into consideration the site criteria contained 

in 10 CFR Part 100, the proposed facility can be constructed and operated at the 

proposed location without undue risk to the health and safety of the public.

(4) There is reasonable assurance: (i) that the construction of the SHINE facility will not 

endanger the health and safety of the public, and (ii) that construction activities can be 

conducted in compliance with the Commission’s regulations.

(5) The issuance of a permit for the construction of the facility would not be inimical to the 

common defense and security or to the health and safety of the public.

10-1

EXPERIMENTAL FACILITIES

SHINE Medical Technologies, Inc. (SHINE or the applicant) Preliminary Safety Analysis Report 

(PSAR) Chapter 10, “Experimental Facilities,” states that the SHINE facility “does not contain 

experimental facilities as described in NUREG-1537 and the Final Interim Staff Guidance 

Augmenting NUREG-1537.” 

The staff evaluated the descriptions and discussions of the SHINE facility in the PSAR and finds 

that the preliminary design of the SHINE facility does not contain experimental facilities. The 

staff concluded that an evaluation of the guidelines of ISG Augmenting NUREG-1537, Part 2 

and NUREG-1537, Part 2 is not required because:

(1) SHINE proposes to produce medical radioisotopes and has not described 

experimental, educational, or other service uses for its facility.

(2) There are no experimental facilities penetrating, located near, or that are an integral 

part of the irradiation units or radioisotope production facility, as described in the 

SHINE PSAR. 

11-1

RADIATION PROTECTION PROGRAM AND 

WASTE MANAGEMENT

The purposes of the radiation protection program and waste management provisions are to 

ensure safety of the SHINE Medical Technologies, Inc. (SHINE or the applicant) irradiation 

facility (IF) and radioisotope production facility (RPF) and protection of the public. The radiation 

protection program and waste management provisions, identified by the analyses in the SHINE 

Preliminary Safety Analysis Report (PSAR), should be conducted using the appropriate 

methods and engineering design criteria. 

This chapter of the SHINE construction permit safety evaluation report (SER) describes the 

review and evaluation of the U.S. Nuclear Regulatory Commission (NRC) staff (the staff) of the 

preliminary design of the SHINE radiation protection program and waste management 

provisions as presented in Chapter 11, “Radiation Protection Program and Waste 

Management,” of the SHINE PSAR, as supplemented by the applicant’s response to requests 

for additional information (RAIs).

Areas of Review

SHINE PSAR Chapter 11, “Radiation Protection Program and Waste Management,” identifies 

the aspects of the radiation protection program and waste management provisions considered 

to ensure facility safety and protection of the public. SHINE PSAR Chapter 11 is applicable to 

both the SHINE IF and RPF. 

The staff reviewed PSAR Chapter 11 against applicable regulatory requirements using 

regulatory guidance and standards to assess the sufficiency of the preliminary design criteria of 

the SHINE facility radiation protection program and waste management provisions. As part of 

this review, the staff evaluated descriptions and discussions of the SHINE facility radiation 

protection program and waste management provisions, with special attention to design and 

operating characteristics, unusual or novel design features, and principal safety considerations. 

The preliminary design of the SHINE facility radiation protection program and waste 

management provisions were evaluated to ensure the design criteria, design bases, and 

information relative to construction is sufficient to provide reasonable assurance that the final 

design will conform to the design basis. In addition, the staff reviewed SHINE’s identification 

and justification for the selection of those variables, conditions, or other items which are 

determined to be probable subjects of technical specifications for the facility, with special 

attention given to those items which may significantly influence the final design.

Areas of review for this section included both the SHINE IF and RPF program. Within these 

review areas, the staff assessed the following:

• The capability of the program to identify and discuss all expected radiation and 

radioactive sources, to include airborne, liquid, solid sources, and radioactive wastes.

• The design and effectiveness of the radiation protection program required by 

10 CFR 20.1101.

• The ability to maintain worker and public doses and radiological releases through an as 

low as is reasonably achievable (ALARA) program, including: (1) a description of the 
Radiation Protection Program and Waste Management

11-2

methods to establish, change, and manage policy for the ALARA program; and (2) a 

description of how the ALARA program is implemented for all activities at the facility to 

maintain radiation doses of all personnel and releases of effluents to the unrestricted 

area ALARA.

• The procedures and equipment at the facility for routinely monitoring and sampling 

workplaces and other accessible locations to identify and control potential sources of 

radiation exposure and releases of radioactive materials.

• The design bases for the equipment and procedures utilized for controlling radiation 

exposures to personnel and releases of radioactive materials from the facility.

• The capability of the dosimetry and other methods to effectively assess exposure to 

radiation and radioactive materials.

• The capability of the program for contamination control to meet all applicable 

requirements of the regulations and the facility ALARA program.

• The capability of the environmental monitoring program to: (1) comply with any 

commitments made by the applicant; (2) establish preoperational baselines used to 

ascertain natural background so that the radiological impact of facility operation on the 

environment can be determined; (3) promote compliance with environmental quality 

requirements through the facility policy and, procedures; (4) ensure that the written plans 

and the bases of procedures for implementing the environmental monitoring programs, 

including changes, are reviewed for adequacy and approved by authorized personnel; 

and (5) establish the environmental surveillance program, including information on the, 

selection of sampling and other program parameters.

• The capability to manage radioactive wastes to include: (1) philosophy of and approach 

to management of the wastes; (2) organization of the management function; (3) program 

staffing and position descriptions, and program personnel responsibilities and 

qualifications as discussed in the format and content guide; (4) any review and audit 

committees related to radioactive waste management; (5) training for staff; (6) plans for 

shipping, disposal, and long-term storage; (7) program documentation and records, 

including availability and retention; (8) audits of the effectiveness of the program; 

(9) bases of procedures; and (10) bases of technical specifications.

• The effectiveness of the radioactive waste control plans at the facility to include methods 

to decrease and eventually minimize the formation of radioactive wastes.

• The methods of characterizing the possible effluents, references to the applicable 

regulations that establish limits for release, descriptions of the identities and amounts of 

radionuclides in the effluents, the release points, and the characteristics of the 

environment to which they are released.
Radiation Protection Program and Waste Management

11-3

Summary of Application

As stated above and described in SHINE PSAR Chapter 11, the radiation protection program 

and waste management provisions are established to ensure facility safety and protection of the 

public.

PSAR Section 11.1.1.1, “Airborne Radioactive Sources,” notes that gaseous activity from the 

TSV will be handled by the Tritium Purification System (TPS) and the TSV Off Gas System 

(TOGS). The noble gas removal system (NGRS) and the process vessel vent system (PVVS), 

which are located in the RPF, will also be used to contain and control airborne activity in the 

facility. All gas treatment systems either exhaust to another treatment system or to the 

radiologically controlled area ventilation system exhaust. In addition to the major airborne 

activity source term within the irradiation units (IUs), an estimated 15 Curies (Ci) of Ar-41 

(T1⁄2 = 1.8 hours) is also produced. To ensure containment of these airborne radioactive 

materials, the heating, ventilation, and air conditioning (HVAC) systems described in PSAR 

Chapter 9a2.1, consist of three stages (designated RVZ1, RVZ2, and RVZ3) to remove airborne 

activity from areas of the facility having the lowest concentration (RVZ3) and cycle it to the 

increasingly higher concentration areas (RVZ2 and RVZ1, respectively). Exhaust air from these 

zones will be pulled through high-efficiency particulate air (HEPA) filters and carbon adsorbers 

to minimize the potential for airborne contamination. In addition the above-mentioned sources 

of airborne activity, N-16 (T1⁄2 = 7.1 seconds) is produced through neutron activation of natural 

nitrogen in the primary coolant loops. The N-16 is contained within the coolant loops; however, 

its decay, accompanied by 6.1 and 7.1 MeV gamma rays, requires shielding design 

consideration for worker safety. Gaseous activity released from the TSV and process 

operations will be collected and sent to the NGRS, which consists primarily of five 100-gallon 

decay tanks and is located in a shielded cell. The gases will be held for 40 days post-irradiation 

to allow short lived fission and activation products to decay to levels that meet regulatory limits 

for release to the environment. The estimated annual dose from airborne effluent releases is 

below 10 mrem. The processes will be remotely controlled, manually controlled, or performed 

with telemanipulators, with minimal automated sequences. Radiation monitors and alarms will 

be used to monitor for release of radiological materials and ambient exposure rates. Gases and 

liquids that contain potentially-radiological material will be transferred through shielded pipe 

chases to limit the exposure of individuals to radiation.

PSAR Section 11.1.1.2, “Liquid Radioactive Sources,” states with the exception of two sources 

(N-16 production and fresh, unirradiated uranyl sulfate solution) all liquid wastes are associated 

with irradiated uranyl sulfate as a target solution. The values in Table 11.1-5 related to IF 

operation show estimated activity of fission products to be present in the subcritical assembly 

system (consisting of the TSV, neutron multiplier, and support structure). Slightly lower 

activities are estimated in the Uranyl Nitrate conversion system (UNCS) that will be handled in 

the RPF portion of the SHINE facility with other sources being either lower in activity or were not 

estimated pending completion of the final safety analysis report (FSAR). This contains the 

majority of byproduct material within the facility; specifically, the fission products generated in 

the TSV. Each of the two waste storage tanks can hold a maximum of 21 TSV batches of 

raffinate. The PSAR states that certain details, such as concentrations and solubilities of major 

liquid sources, will be provided in the FSAR. The PSAR also states that there will be no 

radioactive liquid discharges to the environment from the SHINE facility. 

PSAR Section 11.1.1.3, “Solid Radioactive Sources,” identifies several categories of solid 

radioactive sources expected during operations. On the low end of this activity spectrum is 

enriched uranium feed material. It is converted from a metallic form to an oxide and then to 
Radiation Protection Program and Waste Management

11-4

uranyl sulfate where it enters the irradiation process. The other end of the activity spectrum 

includes spent extraction columns, spent filters, solidified liquid waste and irradiated 

components. Licensed radioactive waste disposal sites that can take receipt and dispose of 

solid radioactive waste are identified in Table 11.2-1 of the PSAR. 

PSAR Section 11.1.2, “Radiation Protection Program,” addresses the following radiation 

protection program elements: responsibilities of key program personnel; staffing of the radiation 

protection program; radiation protection program independence; radiation safety committee; 

written radiation protection procedures; radiation protection training; and radiation safety audits. 

SHINE stated that the radiation protection program responsibility will be vested in the Radiation 

Protection Manager (RPM) and that this individual will report to the Environment, Safety, and 

Health Manager who reports to the Chief Operating Officer (COO). A separate reporting chain 

to the COO is provided for the Plant Manager and his subordinates. This assures separation of 

the radiation safety function from the facility operating component(s), thereby facilitating 

independent radiation safety decisions. This section of the PSAR further stated that in the 

context of written radiation protection procedures, radiation work permits will be developed 

consistent with Regulatory Guide 8.10 whenever the RPM considers them necessary or for any 

activities involving licensed materials not covered by operating procedures and where 

radioactivity levels are likely to exceed airborne activity limits. PSAR 11.1.2 also stated that 

radiation protection training will be developed consistent with Regulatory Guides 8.10, 8.13, and 

8.29, as well as ASTM E1168-95, “Radiological Protection Training for Nuclear Facility 

Workers.” SHINE committed to conduct audits of the radiation protection program at least 

annually.

PSAR Section 11.1.3, “ALARA Program,” states the radiation protection manager (RPM) is 

responsible for implementing the ALARA program and ensuring that adequate resources are 

committed to make the program effective. The RPM will prepare an annual ALARA program 

evaluation report that will review: trends in radiation exposures and effluent release data; the 

results of audits and inspections; the use, maintenance, and surveillance of equipment used for 

exposure and effluent control; and other issues that may influence program effectiveness. The 

program will facilitate interactions between radiation protection and operations personnel, 

particularly through use of the Radiation Safety Committee, where both organizations are 

represented. The applicant committed to the ALARA as applied to plant design, where designs 

are reviewed, updated, and modified as experience is gained. Specifically included in these 

reviews will be shielding, ventilation, and monitoring instrument designs as they relate to traffic 

control, security, access control, and health physics. Additionally, the location of equipment and 

routing of piping containing radioactive fluids is reviewed as part of the design effort to ensure 

that significant sources are adequately shielded and properly routed to minimize exposure of 

personnel. SHINE has indicated that lessons-learned from industry practices and operating 

experience shared by the NRC in the form of generic communications are incorporated into the 

facility design. The design considerations noted in PSAR Section 11.1.3 emphasize remote 

handling capabilities, use of high reliability of components as a means of reducing maintenance 

requirements, and reducing component access and removal times to reduce radiation exposure. 

Specific examples cited by SHINE that assist in maintaining exposures ALARA include:

• Design provisions for maintenance of target solution and light water pool chemistry 

conditions, such that corrosion and resulting activation product source terms are 

minimized.

• Features to allow draining, flushing, and decontaminating equipment and piping.
Radiation Protection Program and Waste Management

11-5

• Design of equipment to minimize the creation and buildup of radioactive material and to 

ease flushing of crud traps.

• Shielding for personnel protection during maintenance or repairs and during 

decommissioning.

• Means and adequate space for the use of movable shielding.

• Separation of more highly radioactive equipment from less radioactive equipment and 

separate shielded compartments for adjacent items of radioactive equipment.

• Shielded access hatches for installation and removal of plant components.

• Design features, such as the means to provide surface decontamination within hot cells.

• Means and adequate space for the use of remote operations, maintenance, and 

inspection equipment.

• Separating clean areas from potentially contaminated ones.

• Locating equipment, instruments, and sampling stations that require routine 

maintenance, calibration, operation, or inspection, to promote ease of access and 

minimize occupancy time in radiation areas.

• Laying out plant areas to allow remote or mechanical operation, service, monitoring, or 

inspection of contaminated equipment.

• Providing, where practicable, for movement of equipment or components requiring 

service to a lower radiation area.

PSAR Section 11.1.4, “Radiation Monitoring and Surveying,” discusses the applicant’s plan to 

use continuous air monitors (CAMs) to provide indications of airborne activity levels in the RCA. 

The CAMs will be supplemented, when needed, by a portable air sampler followed by laboratory 

analysis. Tritium sampling will be conducted in each IU, the TPS glovebox room, and from 

stack effluent. Continuous monitoring of the plant stack releases will be annunciated in the 

control room. SHINE proposes that the production processes will result in zero liquid releases; 

however, continuous monitoring of closed loop systems will be performed. Radiation area 

monitors will be located at unspecified areas and provide indications of exposure rates to the 

control room. At each control point (entrance/exit to the RCA), SHINE has proposed having one 

or more of the following available: a portal monitor, a frisker, a hand and foot monitor, and a 

small article monitor, the latter being used to conduct free-release surveys of tools and similar 

equipment. Additionally, criticality accident and alarm system (CAAS) monitors (gamma and 

neutron detectors with local and control room annunciation) will be provided (locations to be 

included in the FSAR). Also in PSAR Section 11.1.4, the applicant states that radiation surveys 

will be performed to ascertain radiation levels and concentrations that may be present in the 

facility and to detect releases of radioactive material from facility equipment and operations. 
Radiation Protection Program and Waste Management

11-6

Specific surveillance program details were not provided in the PSAR. It was noted, however, 

that survey and monitoring programs will be consistent with the guidance provided in: 

• Regulatory Guide 8.2, “Guide for Administrative Practices in Radiation Monitoring” 

(Reference 80).

• Regulatory Guide 8.7, “Instructions for Recording and Reporting Occupational Radiation 

Exposure Data” (Reference 81).

• Regulatory Guide 8.9, “Acceptable Concepts, Models, Equations, and Assumptions for a 

Bioassay Program” (Reference 82).

• Regulatory Guide 8.24, “Health Physics Surveys During Enriched Uranium-235 

Processing and Fuel Fabrication” (Reference 83).

• Regulatory Guide 8.34, “Monitoring Criteria and Methods To Calculate Occupational 

Radiation Doses” (Reference 84).

PSAR Section 11.1.5, “Radiation Exposure Control and Dosimetry,” defines a Restricted Area 

(defined in 10 CFR 20) to primarily include the RCA and also states that most other restricted 

areas are within the physical structure of the SHINE facility; however, the PSAR notes that 

radioactive material may be temporarily stored in areas outside of the main facility, such as the 

waste staging and shipping building. The applicant has also defined a Controlled Area (also 

defined in 10 CFR Part 20) to include any area beyond the main reception area, but outside of 

the Restricted Area. The applicant also states that members of the public cannot directly enter 

the Controlled Area and must be processed by security and given authorization to enter. SHINE 

has defined an Unrestricted Area for which no access control is exercised and access is not 

limited in any way. This includes all areas outside of the Controlled Area. SHINE recognized 

that the dose in an Unrestricted Area from external sources may not exceed 0.02 mSv (2 mrem) 

in any one hour, and that doses to members of the public may not exceed 100 mrem/year 

above background consistent with 10 CFR 20.1301. The PSAR includes definitions for a 

Radiation Area, Airborne Radioactivity Area, and a High Radiation Area as contained in 

10 CFR 20. Also defined by SHINE (but not in 10 CFR Part 20) is a Contaminated Area. Such 

an area is defined by the presence of removable surface contamination of 0.33 Bq/100 cm2

(20 dpm/100 cm2

) of alpha activity or 16.7 Bq/100 cm2 (1000 dpm/100 cm2) of beta activity. 

Access to the Restricted Area occurs via one of the Control Points where dosimetry and 

protective clothing and equipment are issued. All personnel entering the Restricted Area must 

be properly trained, unless they are escorted by someone who has been trained. Within the 

Restricted Area, a number of High Radiation Areas (HRAs) exist. Access to HRAs will be 

controlled by a combination of administrative methods and a combination of active and passive 

barriers. 

PSAR Section 11.1.5 also states that any personnel entering the Restricted Area will be 

required to wear a beta-gamma dosimetry device in a manner consistent with the 

manufacturer’s directions. Devices will be exchanged quarterly. Exposure control includes 

performing an investigation (and documentation) of any individual exposure greater than 25 

percent of the SHINE administrative limits. The RPM is informed of such exposures. PSAR 

Section 11.1.5 also addresses internal dose assessments. The applicant proposes to use a 

combination of air concentration measurements, measurements of radionuclides in the body, 

and radionuclides in excreta to assess internal dose. SHINE will assume that the measured air 
Radiation Protection Program and Waste Management

11-7

concentration is equal to the inhaled concentration, unless respiratory protective equipment is 

used in accordance with 10 CFR 20.1703 or the intake is determined based on excreta sample 

measurements or whole body counting. PSAR Section 11.1.5 also discusses additional 

facilities, including: locker and change rooms for male and female employees to change into 

clothing suitable for RCA entry; a first aid station to treat injured personnel; a personnel 

decontamination area, and storage areas for anti-contamination clothing; respiratory protective 

equipment; and radiation protection supplies.

PSAR Section 11.1.6, “Contamination Control Equipment and Facility Layout General Design 

Considerations for 10 CFR 20.1406,” addresses design considerations to prevent spread of 

contamination to the facility and the environment for the following: (1) shielded compartments 

and hot cells; (2) monitoring and controlled entry/egress to the Restricted Area; (3) piping 

considerations; (4) a light water pool; and (5) process tanks.

PSAR Section 11.1.7, “Environmental Monitoring,” discusses the applicant’s proposed 

radiological environmental monitoring program (REMP) that routinely includes direct exposure 

monitoring, air sampling and groundwater sampling. Provisions are included for sampling of

other environmental media (termed biota sampling) when triggered by pre-defined off-normal 

releases, should they occur. A preoperational REMP will be conducted and include 

thermoluminescent dosimeters, air, groundwater, and biota in order to establish baseline values, 

which can be referenced by the operational REMP.

PSAR Section 11.2.1, “Radioactive Waste Management Program,” defines the goals of the 

waste management program as: minimizing waste generation, minimizing exposure of 

personnel, and protecting the general public and environment. The applicant discusses the 

following aspects of the program: (1) responsibilities of management and supervisory positions; 

(2) operating procedures; (3) record keeping and document controls; and (4) waste 

management audits.

PSAR Section 11.2.2, “Radioactive Waste Controls,” contains a commitment to describe the 

operational procedures to be used to identify, characterize, and separately treat the different 

waste streams in the FSAR. PSAR Section 11.2.2.1 states that a waste minimization program 

will exist within the radioactive waste management program. PSAR Section 11.2.2.2 presents 

the preliminary identification of waste streams and the proposed controls. 

PSAR Section 11.2.3, “Release of Radioactive Waste,” describes “release” as processing and 

packaging wastes as required to meet the waste acceptance criteria at an established disposal 

facility. Processes are utilized to segregate specific radionuclides important to waste 

classification so to reduce the waste classification of the larger volume of wastes. Several of 

the solid waste streams are packaged then stored in the waste staging and shipping building to 

allow decay of the contents to occur, reducing the waste classification, as well as the radiation 

level of the packages at final disposal. PSAR Section 11.2.3 restates that there are no liquid 

radioactive effluent discharges from the facility. Liquid wastes are processed by ion exchange 

to remove specific radionuclides important to waste classification and by evaporation to 

concentrate the bottoms prior to solidification and disposal. Gaseous wastes from the NGRS 

are held for a minimum of 40 days of decay, sampled and evaluated against release criteria and 

- if sufficiently below the limits - released through a monitored stack.

PSAR Section 11.3, “Respiratory Protection Program,” states that a respiratory protection 

program will be used only when the HVAC or other engineering controls cannot be applied to 

control the intake of radioactive material. The applicant first made reference to these 
Radiation Protection Program and Waste Management

11-8

engineered controls represented by the HVAC system described in Section 9a2.1 of the PSAR. 

The respiratory protection program includes the following elements: (1) air sampling; 

(2) surveys and, when necessary, bioassays; (3) performance testing of respirators for 

operability; (4) written procedures for all key program elements; and (5) determination by a 

physician that the individual user is medically fit to use respiratory protection equipment. The 

applicant also references applicable regulations, industry standards, and provides additional 

information regarding elements of the proposed respiratory protective equipment fit testing 

program.

Additionally, the following PSAR tables provide information on the radiation protection program 

and waste management provisions:

• Tables 11.1-1 through Table 11.1-3 lists the TSV source term parameters, limiting and 

bounding radionuclide inventories, and activity for select radionuclides following 

shutdown.

• Table 11.1-4 through Table 11.1-6 lists various airborne, liquid, and solid radioactive 

sources that are expected to be associated with plant operation, including the IF and 

RPF components.

• Table 11.1-7 provides administrative radiation exposure limits.

• Table 11.1-8 provides the proposed environmental thermoluminescent dosimeters 

locations.

• Table 11.1-9 shows the radionuclides being released with Xe-133 comprising more than 

94percent of the emissions by activity.

• Table 11.2-1 provides a summary of waste types, the waste classification at the time of 

generation, and anticipated volume.

• Table 11.2-2 through 11.2-7 provides waste methodology for various components and 

waste streams.

• Table 4b.4-1 of the PSAR lists estimated special nuclear material (SNM) inventory in the 

RPF.

Regulatory Basis and Acceptance Criteria

As previously stated and described in SHINE PSAR Chapter 11, the radiation protection 

program and waste management provisions are established to ensure facility safety and 

protection of the public. Therefore, the regulatory basis and acceptance criteria provided below 

apply to both the IF and RPF.

The staff reviewed SHINE PSAR Chapter 11 against applicable regulatory requirements, using 

regulatory guidance and standards, to assess the sufficiency of the preliminary design of the 

SHINE radiation protection program and waste management provisions for the issuance of a 

construction permit. In accordance with paragraph (a) of Title 10 of the Code of Federal 

Regulations (10 CFR) 50.35, “Issuance of Construction Permits,” a construction permit 
Radiation Protection Program and Waste Management

11-9

authorizing SHINE to proceed with construction may be issued once the following findings have 

been made:

(1) SHINE has described the proposed design of the facility, including, but not limited to, 

the principal architectural and engineering criteria for the design, and has identified the 

major features or components incorporated therein for the protection of the health and 

safety of the public.

(2) Such further technical or design information as may be required to complete the safety 

analysis, and which can reasonably be left for later consideration, will be supplied in 

the final safety analysis report (FSAR). 

(3) Safety features or components, if any, which require research and development have 

been described by SHINE and a research and development program will be conducted 

that is reasonably designed to resolve any safety questions associated with such 

features or components. 

(4) On the basis of the foregoing, there is reasonable assurance that: (i) such safety 

questions will be satisfactorily resolved at or before the latest date stated in the 

application for completion of construction of the proposed facility taking into 

consideration the site criteria contained in 10 CFR Part 100, and (ii) the proposed 

facility can be constructed and operated at the proposed location without undue risk to 

the health and safety of the public.

With respect to the last of these findings, the staff notes that the requirements of 

10 CFR Part 100 are specific to nuclear power reactors, and therefore not applicable to the 

SHINE facility. However, the staff evaluated SHINE’s site specific conditions using site criteria 

similar to 10 CFR Part 100, by using the guidance in NUREG-1537. The staff’s review 

evaluated the geography and demography of the site; nearby industrial, transportation, and 

military facilities; site meteorology; site hydrology; and site geology, seismology, and 

geotechnical engineering to ensure that issuance of the construction permit will not be inimical 

to public health and safety.

The staff’s evaluation of the preliminary design of the SHINE radiation protection program and 

waste management provisions does not constitute approval of the safety of any design feature 

or specification. Such approval will be made following the evaluation of the final design of the 

SHINE radiation protection program and waste management provisions as described in the 

FSAR as part of SHINE’s operating license application.

Applicable Regulatory Requirements

The applicable regulatory requirements for the evaluation of the SHINE radiation protection 

program and waste management provisions are as follows:

• 10 CFR Part 20, “Standards for Protection Against Radiation.”

• 10 CFR 50.34, “Contents of applications; technical information,” paragraph (a), 

“Preliminary safety analysis report.”

• 10 CFR 50.40, “Common Standards.”
Radiation Protection Program and Waste Management

11-10

Regulatory Guidance and Acceptance Criteria

In applying guidance and acceptance criteria, the staff used its judgment as to which 

acceptance criteria were relevant to SHINE’s proposed facility, as much of this guidance was 

originally developed for nuclear reactors. Given the similarities in SHINE’s proposed facility and 

non-power research reactors, the staff used established guidance documents and the 

Commission’s regulations to determine the acceptance criteria for demonstrating compliance 

with 10 CFR regulatory requirements. For example, the staff used: 

• NUREG-1537, Part 1, “Guidelines for Preparing and Reviewing Applications for the 

Licensing of Non-Power Reactors, Format and Content,” issued February 1996 

(Reference 4).

• 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 (Reference 5).

• “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 (Reference 6).

• “Final Interim Staff Guidance [ISG] 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 (Reference 7).

As stated in the ISG Augmenting NUREG-1537, the staff determined that certain guidance 

originally developed for heterogeneous non-power research and test reactors is applicable to 

aqueous homogenous facilities and production facilities. SHINE used this guidance to inform 

the design of its facility and prepare its PSAR. The staff’s use of reactor-based guidance in its 

evaluation of the SHINE PSAR is consistent with the ISG Augmenting NUREG-1537.

As appropriate, additional guidance (e.g., NRC regulatory guides, Institute of Electrical and 

Electronics Engineers (IEEE) standards, American National Standards Institute/American 

Nuclear Society (ANSI/ANS) standards) has been used in the staff’s review of SHINE’s PSAR. 

The use of additional guidance is based on the technical judgment of the reviewer, as well as 

references in NUREG-1537, Parts 1 and 2; the ISG Augmenting NUREG-1537, Parts 1 and 2; 

and the SHINE PSAR. Additional guidance documents used to evaluate SHINE’s PSAR are 

provided as references in Appendix B of this SER.

Review Procedures, Technical Evaluation, and Evaluation Findings

As described in SHINE PSAR Chapter 11, the radiation protection program and waste 

management provisions are established to ensure facility safety and protection of the public. 

Therefore, the regulatory basis and acceptance criteria provided below applies to both the IF 

and RPF.

The staff performed an evaluation of the technical information presented in SHINE PSAR 

Chapter 11, as supplemented by the applicant’s responses to RAIs, to assess the sufficiency of 
Radiation Protection Program and Waste Management

11-11

the radiation protection program and waste management provisions for the issuance of a 

construction permit, in accordance with 10 CFR 50.35(a). Sufficiency of the radiation protection 

program and waste management provisions is demonstrated by acknowledgement and 

commitments to applicable regulatory requirements, guidance, and acceptance criteria, as 

discussed in Section 11.3, “Regulatory Basis and Acceptance Criteria,” of this SER. The results 

of this technical evaluation are summarized in SER Section 11.5, “Summary and Conclusion.”

For the purposes of issuing a construction permit, the radiation protection program and waste 

management provisions may be adequately described at a functional or conceptual level. The 

staff evaluated the sufficiency of the radiation protection program and waste management 

provisions based on the applicant’s design methodology and ability to provide reasonable 

assurance that the final design will conform to the design bases with an adequate margin for 

safety. As such, the staff’s evaluation of the preliminary design of the SHINE radiation 

protection program and waste management provisions does not constitute approval of the 

safety of any design feature or specification. Such approval will be made following the 

evaluation of the final design of the SHINE radiation protection program and waste management 

provisions, as described in the FSAR, as part of SHINE’s operating license application.

Radiation Sources

The staff evaluated the information provided on the radiation sources, as described in SHINE 

PSAR Section 11.1.1, “Radiation Sources,” using the guidance and acceptance criteria from 

Section 11.1.1, “Radiation Sources,” of NUREG-1537, Parts 1 and 2.

Consistent with the review procedures of NUREG 1537, Part 2, Section 11.1.1, the staff 

evaluated the discussion of potential sources of radiation in the facility, as presented in SHINE 

PSAR Section 11.1.1 and other relevant chapters of the PSAR. The staff compared the 

description of the types of radioactive materials present with the applicable process description, 

including radionuclide inventories and mass balances and chemical and physical forms, to verify 

that all radioactive materials associated with the process have been identified. The staff 

reviewed the description and discussion of all sources of radiation to verify that they are 

described in sufficient detail to provide the bases for the design and assessment of personnel 

protective measures and radiation doses. The staff confirmed that all solid sources of radiation 

at the facility are described and discussed in sufficient detail to permit evaluation of all 

significant radiological exposures related to normal operation, utilization, maintenance, and 

radioactive waste management including processing and shipment.

Although technically it is a part of the Chapter 4 material that describes features of the IU, RAI 

4a2.5-1 and its response are discussed in this section because of the impact of shield thickness 

on occupational radiation exposures. 

The ISG Augmenting NUREG-1537, Part 2, Section 4a2.4, “Biological Shield,” Acceptance 

Criteria, states, in part, that “[t]he principal objective of the shield design should be to ensure 

that the projected radiation dose rates and accumulated doses in occupied areas do not exceed 

the limits of 10 CFR Part 20, ‘Standards for Protection Against Radiation,’ and the guidelines of 

the facility’s ALARA (as low as [is] reasonably achievable) program discussed in Chapter 11 of 

the SAR.”

SHINE PSAR, Section 4a2.5.2.2, “Geometry and Configuration,” states that the side wall of the 

IU cell biological shield consists of standard density concrete that is 6.0 feet (1.8 meters) thick 

and that the dose rates on the external surface of the shield wall is expected to be less than 
Radiation Protection Program and Waste Management

11-12

1.0 millirem/hour. PSAR Section 4a2.5.3.1, “Shielding Calculations,” notes that the Monte-Carlo 

N-Particle (MCNP) Transport Code was used to determine the required shield thickness. PSAR 

Section 4a2.5.4, “Analysis,” states, in part, that analysis is performed to: (1) give detailed 

results of both neutron and gamma-ray dose rates at locations that could be occupied as well as 

to the unrestricted environment; and (2) include shield penetrations and voids, such as 

beamports, thermal columns, and irradiation rooms or vaults, as well as the shielding of piping 

and other components that could contain radioactive materials or allow radiation streaming.

In RAI 4a2.5-1 (Reference 14), the staff asked the applicant to provide a list of the components 

inside the irradiation unit cell that are considered significant contributors (and the magnitude of 

these contributions) to the gamma and neutron flux and dose rates impinging on the interior 

shield wall. For each component, the applicant was requested to describe the key assumptions 

included in the MCNP (or other computer code) radiation transport modeling used to determine 

shield wall thickness.

In response to RAI 4a2.5-1 (Reference 21), the applicant stated the components inside the IU 

cell that are considered to be significant contributors to the gamma and neutron fluxes are the 

neutron driver and the Subcritical Assembly System. The applicant stated, in part, that “[t]he 

interior surface of the IU shield wall was partitioned into two foot by two foot sections above the 

light water pool, and the neutron and gamma flux and dose rates in each section were 

calculated. The doses below the light water pool are not required for shielding purposes as this 

portion of the IU cell is below grade and there are no areas where personnel would normally be 

present below grade near the IU cell.” The applicant provided key assumptions, inputs, neutron 

and gamma dose rates, and fluxes impinging in the 1.8 m thick shield wall for the assertion that 

the dose rate at the exterior of the wall was <1 mrem/hr. The staff was able to determine 

through its qualitative assessment that concrete shielding provided for the IU cells was sufficient 

to reduce the average and peak dose rates at the interior of the shield wall from the neutron 

driver during operation to <1 mrem/hr at the wall exterior. A dose rate of 1 mrem/hr is below the 

limit in 10 CFR 20.1301(a)(2) of 2 mrem in any hour for an unrestricted area. From a radiation 

protection perspective, members of the public could occupy such areas without restriction. The 

staff found that a 1 mrem/hr dose rate was therefore acceptable from a design perspective for 

occupational exposure considerations. The staff will confirm that the final design conforms to 

this design basis during the evaluation of the SHINE FSAR.

The regulations in 10 CFR 50.34(a)(3)(i) require that preliminary design information provided for 

the facility include principal design criteria. SHINE PSAR, Section 11.1.1.1, “Airborne 

Radioactive Sources,” presents information on the management of airborne radioactive sources. 

It states that predicted personnel dose rates (including maintenance activity) due to airborne 

radioactivity and associated methodology will be presented in the FSAR for the SHINE facility. 

In RAI 11.1-1 (Reference 14), the staff asked the applicant to provide design information in 

sufficient detail (including key assumptions) to demonstrate the manner in which airborne 

radioactive material concentrations to which workers may be exposed (especially during 

maintenance activities) will be controlled in order to meet the derived air concentrations 

contained in 10 CFR Part 20, Appendix B, “Annual Limits on Intake (ALIs) and Derived Air 

Concentrations (DACs) of Radionuclides for Occupational Exposure; Effluent Concentrations; 

Concentrations for Release to Sewerage.” The staff further clarified the request by specifically 

asking the applicant to provide the following: 

(a) The expected airborne radioactive material concentrations (partitioned into 

noble gases, radioiodines, and particulates) associated with normal 

operations of the facility compared to their respective derived air 
Radiation Protection Program and Waste Management

11-13

concentrations in various areas that could be occupied by workers. Use 

definitions for airborne radioactivity areas similar to the following in terms of 

the derived air concentrations: Zone 1 (<0.01 – 1.0 derived air concentration), 

Zone 2 (1.0 - 10 derived air concentrations), and Zone 3 (>10 derived air 

concentrations); 

(b) The expected airborne radioactive material concentrations associated with 

facility accidents compared to their respective derived air concentrations in 

various areas that could be occupied by workers; and 

(c) Key assumptions associated with (a) and (b) above, including: 

(i) The basis for the production rate data in PSAR, Table 11.1-9, “Target 

Solution Vessel (TSV), Noble Gas and Iodine Production Rates, Annual 

Releases, and Effluent Concentration Limits (ECL) Fraction at the Site 

Boundary after 960 Hours of Noble Gas Removal System (NGRS) 

Holdup”; 

(ii) A description of leakage pathways (including holdup and 

filtration/adsorption) from the point of production to the point of worker 

exposure; and 

(iii) For the ventilation system: Key parameters and assumptions associated 

with the estimates of airborne radioactive material concentrations in work 

areas.

In response to RAI 11.1-1(a) (Reference 21), the applicant stated that the facility design 

maintains airborne radioactive material concentrations very low in normally occupied areas. 

Confinement and ventilation systems are designed to protect workers from sources of airborne 

radioactivity during normal operation and minimize worker exposure during maintenance 

activities, keeping with the ALARA principles outlined in 10 CFR 20. The applicant also stated 

that they have qualitatively assessed anticipated derived air concentrations for airborne 

radioactive material (noble gases, radioiodines, and particulates), above grade and within the 

RCA at the SHINE facility, during normal operations. The applicant provided PSAR 

Figure 11.1-1-1 as an illustrative depiction of this assessment. Partitioning of airborne 

radioactive material concentrations associated with normal operations into noble gases, 

radioiodines, and particulates will be provided in the FSAR. An issues management report 

(IMR) has been initiated to track the inclusion of this information in the FSAR. The staff 

estimated the dose equivalent associated with the Zone 1 concentrations (up to 1.0 derived air 

concentration (DAC)) was 5 rem/yr. The staff concluded that although this dose equivalent 

meets the annual occupational dose limits in 10 CFR 20.1201, it is not clear that such 

concentrations, if allowed to persist on a regular basis, would be considered ALARA. The upper 

limit for Zone 1 concentrations needs to be further evaluated at the FSAR stage to determine if 

additional measures, such as occupancy limitations, need to be applied as ALARA measures. 

In response to RAI 11.1-1(b) (Reference 21), the applicant provided Table 11.1-1-1, showing 

the expected airborne radioactive material concentrations associated with facility accidents 

compared to their respective DACs. The occupational airborne concentration for each 

radionuclide was compared to the DAC contained in Appendix B to 10 CFR 20. A sum of 

fractions method was used to calculate values for noble gases, radioiodines, and particulates for 

each accident scenario. The DAC values are for areas that could be occupied by workers and 

are applicable throughout the RCA of the SHINE production facility building. Evacuation of the 

workers is to be completed within 10 minutes, as described in PSAR Tables 13a2.2.1-2 and 
Radiation Protection Program and Waste Management

11-14

13b.2.1-2. The staff notes the maximum expected concentrations under accident conditions 

would result in a maximum dose that is within 10 CFR 20 limits and EPA Protective Action 

Guidelines.

In response to RAI 11.1-1(c) (Reference 21), the applicant indicated Table 11.1-9 provides the 

basis for the production rate data which consists of a single TSV operating at the licensed 

power limit. Cumulative fission yields were used to account for both instantaneous fission 

products and decay chain products that would be produced over the course of the entire 

operational cycle. All fission was assumed to occur by thermal neutrons in U-235. Fission of 

transmuted Pu-239 and fast neutron fission of U-238 were assumed to be negligible in 

comparison to U-235 fission rates. A total energy yield for neutron-induced fission of 

200 MeV/fission was used. Decay constants for individual isotopes were used to convert the 

generation rate (atoms/sec) to a fission product activity generation rate (Ci/sec) for each 

radionuclide. The annual releases provided in Table 11.1-9 assume eight TSVs are in 

operation.

Further, the applicant stated that during normal operation, there are no significant anticipated 

leakage pathways for worker exposure in normally occupied areas to airborne radioactive 

material. Normally occupied areas within the RCA will be serviced by RVZ2 and RVZ3. 

Positive pressure will be maintained in normally occupied areas relative to RVZ1 areas, which 

potentially contain airborne radioactive materials. See PSAR Subsection 9a2.1.1 and the 

discussion of key parameters of the ventilation system below for additional information on the 

RV within the SHINE facility. For the leakage pathway to workers during accident events, 

excluding the TPS DBA, the applicant assumed that a maximum of 10 percent of the airborne 

release would escape from the confinement area (e.g., TOGS shielded cell, IU cell, noble gas 

storage cell, hot cells) penetrations prior to the evacuation. Also, for the releases involving 

target solution and the release from the TOGS, the applicant assumed that only 25 percent of 

the available source term is released from the TSV, piping, or TSV dump tank prior to 

evacuation of the facility (0.1 x 0.25 = 0.025). This assumption is made based on the systems 

operating near atmospheric pressure, leading to non-energetic releases, the slow pumping rate 

of the solution from the TSV dump tanks, and the maximum evacuation time for the facility being 

10 minutes. For the TPS DBA, no reduction was credited for confinement features for workers, 

resulting in a leak path factor of 1.0. Regarding key parameters of the ventilation system during 

normal operations, the applicant states that ventilation within the SHINE facility is a oncethrough system with cascading ventilation zones designed to protect workers from exposure to 

airborne radioactive material. RVZ2 areas will receive outside air through the RVZ2SA air 

handling units and exhaust through the RVZ2 exhaust header, which will be maintained at a 

negative pressure relative to outside air. RVZ2 areas are expected to receive a small fraction of 

air from RVZ3, which also receives its supply air from the RVZ2SA air handing units. Areas 

serviced by RVZ1 (e.g., IU cells, hot cells) will be maintained at a negative pressure in relation 

to RVZ2 to prevent leakage of airborne radioactive material into normally occupied areas (see 

Subsection 9a2.1.1 of the PSAR for additional information on the RV). Regarding key 

parameters of the ventilation system during accident conditions, the applicant states that during 

an accident event in areas of the facility serviced by RVZ1, bubble-tight isolation dampers in the 

RVZ1 exhaust will close. No components of the RV (e.g., dampers or filters) are credited with 

reducing worker exposure during accident events.

While the staff finds that SHINE’s preliminary analysis of expected airborne radioactivity 

concentrations meet the dose requirements of 10 CFR Part 20 and EPA Protective Action 

Guidelines and are sufficient to proceed with construction, due to the significant source term

proposed in the liquid waste storage system and operator presence near the Molybdenum 
Radiation Protection Program and Waste Management

11-15

Extraction and Purification System (MEPS), additional information is needed before construction 

is completed to confirm the adequacy of the design of SHINE’s supercells and tank 

vaults. Specifically, SHINE’s design must sufficiently shield personnel from the materials 

contained within the liquid waste storage tanks and MEPS to meet the proposed administrative 

limits for dose rate in normally occupied areas. 

Therefore, the staff recommends that the construction permit include a condition that 

requires, prior to the completion of construction, SHINE submit periodic reports to the 

NRC, at intervals not to exceed 6 months from the date of the construction permit. As 

described in the proposed permit conditions in Appendix A of this SER, these reports 

shall provide the design information on the RPF supercells, tank vaults containing the 

liquid waste storage tanks, evaporation hot cells, and liquid waste solidification hot cells 

demonstrating shielding, and occupancy times within the RPF are consistent with as low 

as is reasonably achievable practices and dose requirements of 10 CFR Part 20.

As required by 10 CFR 50.34(a)(3)(i), the preliminary design information provided for the facility 

shall include principal design criteria. As specified in 10 CFR 20.1101(d), “[t]o implement the 

ALARA requirements of § 20.1101 (b), and notwithstanding the requirements in § 20.1301 of 

this part, a constraint on air emissions of radioactive material to the environment, excluding 

Radon-222 and its daughters, shall be established by licensees other than those subject to 

§ 50.34a, such that the individual member of the public likely to receive the highest dose will not 

be expected to receive a total effective dose equivalent in excess of 10 mrem (0.1 mSv) per 

year from these emissions.” As stated in 10 CFR 20.1301, each licensee shall conduct 

operations so that the 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.

SHINE PSAR Section 11.1.1.1, “Airborne Radioactive Sources,” presents information on the 

public doses to the Maximally Exposed Individual (MEI). Consistent with the guidance in NRC 

Regulatory Guide 4.20, “Constraint on Releases of Airborne Radioactive Materials to the 

Environment for Licensees other than Power Reactors” (Reference 85), the effluent 

concentration values are compared with the effluent concentration limits in 10 CFR Part 20, 

Appendix B, Table 2 for showing compliance with the requirements of 10 CFR 20.1101(d). 

These concentration limits, however, only account for environmental pathway doses attributed 

to the inhalation pathway. Other environmental pathways, such as for radioiodine accumulation 

via the air-pasture grass-milk pathway, merit evaluation in the calculation of the total effective 

dose equivalent to individual members of the public. NRC Regulatory Guide 1.109, “Calculation 

of Annual Doses to Man from Routine Releases of Reactor Effluents for the Purpose of 

Evaluating Compliance with 10 CFR Part 50, Appendix I,” (Reference 86), may be used as a 

reference for evaluating environmental pathway doses, as needed. 

In order for the NRC staff to determine the adequacy of SHINE’s conduct of operations and 

implementation of ALARA requirements, additional information was needed on the total effective 

dose equivalent to individual members of the public, considering all environmental pathways, to 

demonstrate compliance with 10 CFR 20.1301. 

Therefore, in RAI 11.1-9 (Reference 15), the staff asked the applicant to provide design basis 

dose calculations for the MEI, considering all age groups and all applicable pathways, 

examining, in particular, the closest recipients in each of the sixteen (16) meteorological sectors. 

The environmental pathway dose assessment should include, but not necessarily be limited to, 

the cow and goat milk from the two dairy operations noted in PSAR Section 11.1.7.2.3.
Radiation Protection Program and Waste Management

11-16

In response to RAI 11.1-9 (Reference 23), the applicant prepared an analysis of the total 

effective dose equivalent (TEDE) to individual members of the public, considering possible 

environmental pathways for airborne releases, to demonstrate compliance with 

10 CFR 20.1301, as well as 10 CFR 20.1101(d). The applicant stated that the facility does not 

have liquid effluent pathways from the Radiologically Controlled Area (RCA). The applicant 

provided the design basis dose calculation for the MEI and the nearest full-time resident for 

normal operations in an attachment to the response titled, “Assessment of Dose to the Public 

due to Normal Gaseous Effluent Releases (ATKINS-NS-DAC-SHN-15-01, Revision 0).” The 

assessment analyzed releases using the GENII2 computer code, version 2.10.1. The analysis 

considered doses in each of the 16 meteorological sectors. Within 5 miles of the SHINE facility, 

there are both dairy and goat production. The analysis considered consumption of goat and 

cow milk and determined goat milk consumption was more limiting; therefore, the total doses 

are reported for the consumption of only goat milk. As shown in the calculation, the annual 

doses for the MEI and nearest full-time resident were calculated to be 9.0 mrem and 0.6 mrem, 

respectively.

As noted in RAI 11.1-9 (Reference 23), the effluent concentration limits (ECL) in 10 CFR 

Part 20, Appendix B, Table 2 only account for environmental pathway doses attributed to the 

inhalation pathway. The GENII2 computer code accounts for this pathway and other pathways, 

such as the meat ingestion, milk ingestion, and leafy vegetable ingestion pathways. As 

described in 10 CFR 20.1302(b), it is acceptable to demonstrate compliance with the annual 

dose limit in 10 CFR 20.1301 by calculating the TEDE to the individual likely to receive the 

highest dose from the licensed operation and comparing this to the annual dose limit. The 

applicant used this method to demonstrate compliance with the annual dose limit in 

10 CFR 20.1301. The applicant also provided updates to PSAR Chapter 11 and 19 as a result 

of the response.

The response provided the requested environmental pathway dose analysis that addressed the 

100 mrem/yr public dose limit and the ALARA provision of 10 CFR 20.1101(d). After reviewing 

SHINE's assessment, the staff concluded that the pedigree of the GENII2 computer code was 

not in question; rather, it was the specification of certain input parameters. Specifically, 

additional questions remained regarding the methods used for deposition for radioiodines. 

Following additional discussions, in its response to RAI 13a2.2-5 (letter dated May 20, 2015), 

SHINE committed to do additional analyses in the FSAR to show compliance with 

10 CFR 20.1101(d), addressing effluent source term reflecting final design engineering controls, 

updated meteorological dispersion and deposition, radioiodine species and depositing fractions, 

and a final dose assessment. SHINE issued an Issues Management Report (IMR) to track the 

inclusion of this issue in the FSAR. The staff is keeping track of this commitment in Appendix A 

of this SER.

SHINE PSAR Section 11.1.1.1, “Airborne Radioactive Sources,” states that “[t]he tritium 

purification system and neutron driver are designed such that the estimated annual doses to the 

maximally exposed individual (MEI) and the nearest resident are below the regulatory limits 

specified in 10 CFR 20.1101(d).” However, additional information was needed for the 

NRC staff to determine the adequacy of SHINE’s implementation of the applicable limits of 

10 CFR Part 20. Therefore, in RAI 11.1-11 (Reference 17), the staff asked the applicant to 

clarify that all the activities in the SHINE Radioisotope Production Facility are designed to meet 

the requirements of 10 CFR 20.1101(d), as the current statement in the SHINE PSAR only 

applies to the tritium purification system and neutron driver. 
Radiation Protection Program and Waste Management

11-17

In response to RAI 11.1-11, (Reference 26),the applicant stated that, in addition to the design of 

the Tritium Purification System (TPS) and the neutron driver, all activities in the IF and RPF are 

designed to meet the dose constraint specified in 10 CFR 20.1101(d). SHINE has revised 

PSAR Section 11.1.1.1 to clarify that activities in the IF and RPF are designed such that the 

estimated annual doses to the MEI and the nearest resident are below the dose constraint 

specified in 10 CFR 20.1101(d). The staff finds that this response sufficiently clarified SHINE’s 

intent to comply with dose constraints in 10 CFR 20.1101(d) for the activities in the IF and RPF 

and demonstrates an adequate methodology for a preliminary design.

SHINE PSAR Section 11.1.1 (page 11-2), states that special nuclear material inventories are 

tabulated in Tables 4b.4-1 and 4b.4-13 for the SHINE Radioisotope Production Facility (RPF). 

The amount of U-235 represented in Table 4b.4-1 (based on the inventory of special nuclear 

material and the level of enrichment) does not seem to agree with the amount of U-235 process 

inventory specified in Table 4b.4-13. Therefore, in RAI 11.1-14 (Reference 17), the staff asked 

the applicant to specify the quantity of special nuclear material and U-235 processed at one 

time in the RPF, ensuring that the values in Tables 4b.4-1 and 4b4-13 are consistent.

In response to RAI 11.1-14 (Reference 26), the applicant provided the RPF inventory of SNM, 

which includes: storage, preparation processes, awaiting reuse in the TSV or other 

processing/adjustment, active extraction processes, Uranyl Nitrate Conversion System (UNCS) 

processes, and waste streams and packaged waste. The applicant discussed how Table 4b.4-1 

represents an estimate of the total SNM inventory within the RPF at one time. The applicant 

then discussed that the values in Table 4b.4-13 of the PSAR specify only a per batch quantity of 

the fissile isotopes uranium-233, uranium-235, and plutonium-239, rather than a total inventory 

(e.g., eight batches of recycled target solution can be contained within the eight target solution 

hold tanks). Based on this information, the applicant stated that the values in Table 4b.4-1 and 

Table 4b.4-13 provide alternate means to estimate the quantity of SNM in the RPF, and are not 

inconsistent. The staff finds this response clarified the values in Tables 4b.4-1 and 4b.4-13 and 

demonstrates an adequate methodology for a preliminary design. 

SHINE PSAR Section 11.1.1, (page 11-2) contains a commitment to implement sufficient 

shielding to ensure direct exposure rates do not exceed 0.25 mrem/hr, except during tank 

transfers. The staff determined it needed additional information on the dose rates that will occur 

during the tank transfers to ensure consistency with ALARA and the dose limits. Therefore, in 

RAI 11.1-15(a) (Reference 17), the staff asked the applicant to explain why dose rates during 

tank transfers that exceed 0.25 mrem/hr are acceptable and consistent with ALARA principles. 

The RAI asked SHINE to explain why shielding will not be used for the tank transfers.

In response to RAI 11.1-15(a) (Reference 26), the applicant stated that it is committed to an 

operating philosophy that maintains occupational exposures to radiation consistent with ALARA 

principles. These ALARA principles include limiting exposure through temporary and 

permanent shielding of radioactive material, providing sufficient distance between personnel 

and radioactive material, and limiting the time personnel are exposed to radioactive material. 

SHINE stated that the facility will be designed to the goal of 0.25 mrem/hr for normally occupied 

locations during normal operations, which includes routine, planned tank transfers. For 

example, SHINE evaluated the shielding requirements for the operator workstation of the Mo-99 

extraction Supercell assuming target solution is being transferred through the cell for the 

extraction process. Shielding thickness was set to meet the goal of 0.25 mrem/hr during this 

process. SHINE stated that some areas in the SHINE facility, such as areas where target 

solution piping transitions into a hot cell, may have dose rates that locally exceed 0.25 mrem/hr 

during some solution transfers. The increased dose rates will be monitored by RP staff and the 
Radiation Protection Program and Waste Management

11-18

areas will be posted appropriately. The staff finds this response clarified that the tank transfer 

shielding design is consistent with ALARA principles, and is therefore acceptable.

Additionally, SHINE PSAR Section 11.1.1.1 provides annual dose estimates for the maximum 

exposed member of the public, but does not state whether the dose rate limit in 10 CFR 

20.1301 will also be met. Therefore, in RAI 11.1-15(b) (Reference 17), the staff asked the 

applicant to demonstrate that in addition to meeting the annual dose limit, the dose rate limit in 

10 CFR 20.1301 will also be met.

In response to RAI 11.1-15(b) (Reference 26), the applicant states that annual doses to the 

public were calculated and were determined to be below the annual dose limit from airborne 

effluents in 10 CFR 20.1301 of 0.1 rem/yr and below the 10 CFR 20.1101 ALARA air emissions 

annual dose constraint of 0.01 rem/yr. Exposures are due to the periodic release of decayed 

noble gases in the NGRS to the PVVS and normal continuous releases of Ar-41 from IU cells. 

PVVS and the IU cells are connected to RVZ1, which exhausts to the atmosphere through the 

facility exhaust stack. SHINE expects the Ar-41 releases to be continuous during operation and 

calculated such releases to result in less than 1 mrem TEDE to the MEI over the course of a 

year. SHINE estimated the total dose to the MEI at 9.0 mrem over an entire year. Based on 

this, SHINE estimates that the unrestricted area dose rate will be less than 0.0009 rem in any 

one hour, well below the 10 CFR 20.1301 dose rate limit of 0.002 rem in any one hour.

The staff finds that based on assumed releases from the NGRS, SHINE’s design of the NGRS 

demonstrates an ability to meet the requirements in 10 CFR 20.1301. The staff will confirm that 

the final design conforms to this design basis during the evaluation of SHINE’s FSAR.

SHINE PSAR Section 11.1.1.2, (page 11-3 and 11-4) “Liquid Radioactive Sources,” describes 

liquid radioactive sources at the SHINE facility. However, the staff determined it needed 

additional information to determine the adequacy of the design of the SHINE facility to protect 

workers and the public from radiation exposures due to liquid radioactive sources. Therefore, in 

RAI 11.1-16 (Reference 17), the staff asked the applicant to provide a description of the safety 

features in place to prevent exposures to liquid radioactive sources, (e.g., regular maintenance, 

shielding, berms).

In response to RAI 11.1-16 (Reference 26), the applicant stated there are safety features in 

place to prevent exposures to liquid radioactive sources. The primary barriers to preventing 

worker exposure to liquid radioactive sources are prevention of leakage and shielding. SHINE 

stated that the systems that contain radioactive liquids will be made from corrosion-resistant 

materials based on the chemical composition of the materials they contain, to minimize the 

potential for leaks. The applicant stated that it will have a Preventive Maintenance Program for 

components such as valves to identify, prevent, and correct leakage. Significant radioactive 

liquid sources (e.g., the irradiated target solution material, UREX process, and raffinate waste 

liquid from UREX) will be located in shielded cells, underground vaults, and trenches. SHINE 

also stated that berms will be used as needed in conjunction with other leak collection safety 

features to direct and contain radioactive liquid leak flows and reduce potential for personnel 

exposure should a leak occur.

The staff finds this response adequately describes safety features that will be in place to prevent 

exposures to liquid radioactive sources to meet the acceptance criteria in NUREG-1537, 

Section 11.1.1, and is therefore acceptable for a preliminary design.
Radiation Protection Program and Waste Management

11-19

On the basis of its review, the staff has determined that the level of detail provided for the 

preliminary design satisfies the applicable acceptance criteria of NUREG-1537, Part 2, 

Section 11.1.1, allowing the staff to make the following relevant findings: (1) potential radiation 

sources and associated doses including the inventories, chemical and physical forms, and 

locations of radioactive materials, and other facility radiation and operational parameters related 

to radiation safety presented in the PSAR have been sufficiently described; (2) the bases for 

identifying potential radiation safety hazards with the process and facility descriptions have been 

compared to verify that such hazards were accurately and comprehensively identified; and 

(3) the PSAR identifies the potential radiation safety hazards associated with the SHINE facility 

and provides an acceptable basis for the development of the radiation protection program.

Therefore, with the exception of the aforementioned construction permit condition, the staff finds 

that the radiation sources of the SHINE facility meets the applicable regulatory requirements 

and acceptance criteria of NUREG-1537 for the issuance of a construction permit in accordance 

with 10 CFR 50.35 and 50.40.

Radiation Protection Program

The staff evaluated the information provided on the radiation sources, as described in SHINE 

PSAR Section 11.1.2, “Radiation Protection Program,” using the guidance and acceptance 

criteria from Section 11.1.2, “Radiation Protection Program,” of NUREG 1537, Parts 1 and 2.

Consistent with the review procedures of NUREG-1537, Part 2, Section 11.1.2, the staff 

evaluated: (1) the roles, responsibilities, authorities, organization, and staffing of the radiation 

protection organization; (2) the roles, responsibilities, authorities, staffing, and operation of 

committees responsible for the review and audit of the radiation protection program; (3) the 

effectiveness and comprehensiveness of the radiation protection training program; (4) radiation 

protection plans and information that form the bases of procedures and the management 

systems employed to establish and maintain them; (5) the effectiveness and 

comprehensiveness of the program for independent oversight reviews and audits of the 

radiation protection program; (6) the effectiveness and comprehensiveness of the process to 

evaluate the radiation protection program to improve the program and the process to examine 

problems and incidents at the facility; and (7) the management of records relating to the 

radiation protection program.

Although it is also a part of the Chapter 9 material that discusses RCA material handling, 

RAI 11.1-2 and its response are discussed in this section because of the importance of having 

appropriately trained radiation workers. 

SHINE PSAR, Section 9b.7.2, “RCA Material Handling,” provides information on the equipment 

used to move or manipulate radioactive material within the RCA, but there is no discussion or 

reference to the training/qualification of personnel who operate the equipment. In addition, as 

required by 10 CFR 71.5, “Transportation of licensed material,” any facility that transports and 

delivers shipments from across state lines must assure that its personnel, who are expected to 

handle radioactive materials, are adequately trained and qualified in accordance with U.S. 

Department of Transportation regulations in 49 CFR Part 172, “Hazardous Materials Table, 

Special Provisions, Hazardous Materials Communications, Emergency Response Information, 

Training Requirements, And Security Plans,” Subpart H, “Training.”

Therefore, in RAI 11.1-2 (Reference 14), the staff asked the applicant to provide additional 

information clarifying whether the training and qualification program for radiation workers will 
Radiation Protection Program and Waste Management

11-20

include elements to assure that personnel who are expected to handle radioactive materials are 

adequately trained and qualified in accordance with 49 CFR Part 172, Subpart H.

In response to RAI 11.1-2 (Reference 20), the applicant responded that in accordance with 

10 CFR 71.5, the SHINE Training Program will include elements to assure that radiation 

workers expected to handle radioactive materials are adequately trained and qualified in 

accordance with Subpart H of 49 CFR Part 172. The staff finds this response sufficiently 

provided the applicant’s intent to ensure radiation workers will be appropriate training and 

qualified in accordance with Subpart H of 49 CFR Part 172. 

SHINE PSAR Section 11.1.2.1.5, (pg. 11-8) “Commitment to Written Radiation Protection 

Procedures,” states that radiation work permits (RWPs) will be used for both routine and 

non-routine activities. The NRC staff determined it needed additional information to determine 

the adequacy of the organization of SHINE’s radiation protection program procedures. The 

description of RWPs appears contradictory because it requires RWPs for routine activities which 

should already be covered by existing operating procedures. Therefore, in RAI 11.1-17 

(Reference 17), the staff asked the applicant to clarify the conditions under which RWPs will be 

used and clarify under what conditions routine activities, typically covered by existing operating 

procedures, would also require RWPs.

In response to RAI 11.1-17 (Reference 26), the applicant stated that all work in the RCA will be 

performed under a RWP, including any activity in the RCA covered by an existing operating 

procedure. The applicant also revised PSAR Section 11.1.2.1.5 to clarify that all work 

performed in the RCA is performed consistent with an RWP. The staff finds this response 

sufficiently provided the applicant’s intent to conduct work under a RWP.

On the basis of its review, the staff has determined that the level of detail provided on the 

radiation protection program is adequate and satisfies the applicable acceptance criteria of 

NUREG-1537, Part 2, Section 11.1.2, allowing the staff to make a finding that the applicant’s 

commitments to develop and conduct a radiation protection program as presented in the PSAR: 

(1) will likely comply with applicable requirements; and (2) gives reasonable confidence that 

management’s commitment to radiation protection in all activities will protect the facility staff the 

environment, and the public from unacceptable exposure to radiation.

Therefore, the staff finds that the radiation protection program is sufficient and meets the 

applicable regulatory requirements and guidance for issuance of a construction permit in 

accordance with 10 CFR 50.35.

ALARA Program

The staff evaluated the sufficiency of the provisions at the facility for maintaining worker and 

public doses and radiological releases ALARA, as described in SHINE PSAR Section 11.1.3, 

“ALARA Program,” using the guidance and acceptance criteria from Section 11.1.3, “ALARA 

Program,” of NUREG-1537, Part 2.

Consistent with the review procedures of Section 11.1.3 of NUREG-1537, Part 2, the staff 

considered the elements of the ALARA program to ensure: (1) radiation doses received by 

facility staff and members of the public are maintained as low as is reasonably achievable; 

(2) the highest levels of facility management are committed to the ALARA program; 

(3) exposure records are periodically reviewed, analyzed for trends and factors, and methods 

evaluated for reducing exposures; and (4) sufficient emphasis and resources are given to 
Radiation Protection Program and Waste Management

11-21

ALARA considerations during design, construction, operation, maintenance, and disposal 

activities.

The staff’s review determined that the ALARA program proposed by SHINE consisted of two 

primary components: (1) overall program considerations (including design, construction, and 

operations policies); and (2) program design considerations. In terms of ALARA policies, the 

PSAR states that SHINE will update and modify facility design and layout as experience is 

gained related to plant design and layout regarding traffic control, security, access control and 

health physics. Regarding program design considerations, the PSAR notes that key operational 

elements of equipment and facility design to maintain exposures ALARA have been considered, 

for example: (1) locating equipment, instruments, and sampling stations that require routine 

maintenance such that easy access is promoted and occupancy time is minimized; (2) locating 

redundant component containing radioactive material in separate compartments so that the 

operating component does not cause significant radiation exposure to individuals performing 

maintenance on the shutdown component; and (3) providing adequate space to store and utilize 

mobile shielding when needed.

SHINE PSAR, Section 11.1.2, “Radiation Protection Program,” and Section 11.1.3, “ALARA 

Program,” discuss SHINE’s commitment to the radiation protection program implementation and 

the proposed content of the ALARA program. Responsibilities of the plant manager and the 

environment, safety and health manager (and his subordinate, the radiation protection manager) 

are outlined with regard to the control of occupational radiation exposure. Both individuals 

report to the chief operating officer, providing the needed separation of the radiation protection 

component from the operating component. 

The staff noted that missing from the PSAR, however, was the commitment to develop a 

management policy statement(s) that demonstrates SHINE’s commitment to maintaining 

occupational and public radiation exposures ALARA. Therefore, in RAI 11.1-3 (Reference 14), 

the staff asked the applicant to provide such a commitment to develop an ALARA policy 

statement(s).

In response to RAI 11.1-3 (Reference 20), the applicant stated that the SHINE Radiation 

Protection Program will include a management policy statement, demonstrating SHINE’s 

responsibility to maintain occupational and public radiation exposures ALARA. SHINE initiated 

an IMR to track the inclusion of an ALARA policy statement in the Radiation Protection 

Program. Following the receipt of SHINE’s FSAR, staff will confirm that this issue has been 

resolved.

SHINE PSAR Section 11.1.3.2.1, “General Design Considerations for ALARA Exposures,” 

indicates that ALARA is applied to the general design considerations and methods without any 

explanation. Therefore, in RAI 11.1-12 (Reference 17), the staff asked the applicant to describe 

how ALARA is applied to the general design considerations and methods.

In response to RAI 11.1-12 (Reference 26), the applicant stated that general design 

considerations and methods to maintain in-plant radiation exposures ALARA at the SHINE 

facility are consistent with the recommendations of Regulatory Guide 8.8, “Information Relevant 

to Maintaining Occupational Radiation Exposure as Low as Practicable (Nuclear Reactors)” 

(Reference 87). SHINE also stated that ALARA design considerations are described in PSAR 

Sections 11.1.3.2.1, 11.1.3.2.2, and 11.1.3.2.3. The staff finds this response adequately 

describes how ALARA is applied to meet the acceptance criteria in NUREG-1537, Part 2, 

Section 11.1.3.
Radiation Protection Program and Waste Management

11-22

SHINE PSAR Section 11.1.3.2, “ALARA Program Design Considerations,” states in part, that 

“[t]he basic management philosophy guiding the SHINE facility design effort so that radiation 

exposures are ALARA can be expressed as: [d]esign structures, systems and components to 

reduce the radiation fields and control streaming, thereby reducing radiation exposure during 

operation, maintenance, and inspection activities.” However, additional information was needed 

for the NRC staff to determine whether the design of structures, systems, and components to 

reduce radiation fields and control streaming are designed to meet ALARA requirements. 

Therefore, in RAI 11.1-13 (Reference 17), the staff asked the applicant to describe how the 

ALARA concepts of time, distance and shielding are incorporated into the design of structures, 

system and components for employee work stations.

In response to RAI 11.1-13 (Reference 26), the applicant stated that employee work stations 

within the RCA will be designed using the ALARA concepts of time, distance, and shielding to 

minimize employee exposures. The applicant further described how time, distance and 

shielding concepts would be integrated into employee work stations. The applicant also 

provided PSAR Section 11.1.1, which states that the goal for the normal operations dose rate 

for normally occupied locations in the facility is 0.25 mrem/hr at the surface, which is 

inconsistent with Subsections 3.5a.10.2.2 and 3.5b.1.9.2.2 with respect to the design dose rate 

of 0.25 mrem/hr at 12 in. from the surface. SHINE has revised PSAR Section 11.1.1 to state 

that the goal for the normal operations dose rate for normally occupied locations in the facility is 

0.25 mrem/hr at 12 in. from the surface of the shielding. 

On the basis of its review, the staff has determined that the level of detail provided on the 

ALARA program satisfies the applicable acceptance criteria of NUREG-1537, Part 2, 

Section 11.1.3, and is consistent with applicable guidance contained in Regulatory Guide 8.8 

(Reference 87), and Regulatory Guide 8.10, “Operating Philosophy for Maintaining 

Occupational Radiation Exposures As Low As Practicable” (Reference 88). Thus, the staff 

makes the following relevant findings: (1) the applicant has clearly defined an ALARA program 

that has guided the design of plant features to ensure occupational and public exposures will be 

maintained at the lowest practicable level; (2) the applicant has designated a responsible 

individual for developing the ALARA program and formally evaluating its effectiveness annually; 

and (3) a number of ALARA features have been included in plant design, such as attention to 

shielding to avoid radiation streaming situations, inclusion of maintenance features that provide 

for remote handling and flushing of components, features that minimize build-up of radioactive 

material in pipes, tanks, and other components, and separation of components and use of 

shielding whenever practical. 

Therefore, the staff finds that the ALARA program is sufficient and meets the applicable 

regulatory requirements and guidance for issuance of a construction permit in accordance with 

10 CFR 50.35 and 50.40.

Radiation Monitoring and Surveying

The staff evaluated the sufficiency of the radiation monitoring equipment and the performance of 

radiation surveys, as described in SHINE PSAR Section 11.1.4, “Radiation Monitoring and 

Surveying,” using the guidance and acceptance criteria from Section 11.1.4, “Radiation 

Monitoring and Surveying,” of NUREG-1537, Part 2.

Consistent with the review procedures of Section 11.1.4 of NUREG-1537, Part 2, the staff 

considered the design of the instrumentation systems used for both routine and special radiation 

monitoring and sampling to ensure compliance with the applicable acceptance criteria. The 
Radiation Protection Program and Waste Management

11-23

staff evaluated the positions of air sampling or monitoring equipment to measure airborne 

concentrations of radioactive material to which people are exposed. The staff considered 

whether radiation monitoring and alarms, as described in the PSAR, provide adequate warning 

and coverage and are of sufficient sensitivity to ensure that any significant increase in radiation 

exposure rates or concentration of airborne radioactive material within the restricted area, 

controlled area (if present), or in the unrestricted area would be detected and would initiate 

appropriate annunciation or action. The staff coordinated this review with the Chapter 7, 

“Instrument and Control Systems,” review and evaluated the design of the radiation 

instrumentation systems used for radiation monitoring and dosimetry to verify compliance with 

the acceptance criteria. The staff also considered whether these radiation monitors and alarm 

systems will be maintained, operated, calibrated, and subjected to surveillance in compliance 

with the appropriate standards and are addressed in the technical specifications. Finally, the 

staff reviewed the facility warning and annunciator systems to ensure they are designed to alert 

personnel to a radiological hazard or abnormal condition in sufficient time to enable them to 

respond in a planned appropriate manner. The staff also confirmed that the interface between 

the radiation monitoring system and the engineered safety features (as discussed in Chapter 6) 

and the discussion of the radiation monitoring system in the emergency plan are appropriate.

The applicant has stated that several different types of sampling and monitoring equipment will 

be located at points within the RCA, at control points where exits from the RCA occur, and at 

the plant stack where effluents may be released. The applicant notes that continuous air 

monitors (CAMs) will be used in the controlled and restricted areas of the facility; however, the 

specific locations and number of such CAMs were not provided. Airborne tritium sampling is 

proposed in PSAR 11.1.4.1 for each of the IU cells, and the tritium purification system glovebox 

room. The stack release monitor will provide continuous monitoring of noble gases and 

continuous sampling of radioiodines, particulates, and tritium. Control point monitoring will be 

performed using a combination of portal monitors, friskers, hand/foot monitors, and small article 

(hand tools) monitors. The staff notes that details vary in terms of their level of specificity; 

however, the commitments and general descriptions are sufficient for the PSAR and, therefore, 

are acceptable.

Regarding radiation surveys, the applicant has stated that written procedures will be developed 

to orchestrate the surveillance program and that it will ensure compliance with the requirements 

of Subparts C, F, L, and M of 10 CFR Part 20. The applicant has also stated that the guidance 

of several Regulatory Guides (8.2, 8.7, 8.9, 8.24, and 8.34) (References 80-84, respectively) will 

be met when the program is implemented. These commitments and general descriptions are 

viewed as sufficient for the PSAR and, therefore, are acceptable.

SHINE PSAR Section 11.1.4.1, “Radiation Monitoring,” provides an overview of the survey and 

monitoring program and indicates that radiation area monitors (RAMs) will be used at the 

SHINE facility. However, there was neither information on oversight and implementation of the 

radiation monitoring program nor the location or conditions that will be present for these 

monitors to be installed. Therefore, the NRC staff determined that additional information was

needed to determine the adequacy of the design of the SHINE facility to ensure that air, liquids, 

solids, and reactor radiation beams and effluents are monitored and sampled as necessary.

Further information was also needed to determine that radiation monitoring equipment will have 

the appropriate calibration and maintenance to ensure that contamination monitoring 

procedures performed at the control point meet 10 CFR Part 20 requirements regarding the 

performance of radiation surveys.
Radiation Protection Program and Waste Management

11-24

Therefore, in RAI 11.1-18 (Reference 17), the staff asked the applicant to: (a) provide additional 

information on the location and conditions that will result in the instillation of RAMs and provide 

sufficient information to determine if RAMs will be used in locations where exposures may 

exceed administrative limits under normal operations or credible accident conditions, as 

determined by the Integrated Safety Analysis or equivalent means; (b) describe the function or 

program (e.g., radiation protection program) that is responsible for implementing the radiation 

survey and monitoring program and will have written procedures that specify the types, times, 

and methods for radiation sampling and monitoring; (c) specify the alarm levels or identify the 

function or program (e.g., radiation protection program) responsible for setting these limits and 

the methodology to be used to establish these values (e.g., administrative limits; and (d) provide 

additional information to clarify which group (e.g., the radiation protection program) is 

responsible for maintaining and checking the radiological monitoring equipment.

In response to RAI 11.1-18 (Reference 26), SHINE stated that will provide the requested 

information in the radiation protection program in the FSAR as part of the detailed design. The 

staff finds this information is largely procedural in nature and therefore acceptable to submit with 

the FSAR.

SHINE PSAR Section 6b.2.1.2, (page 6b-5) “Confinement System and Components,” and 

Table 6b.1-1, “Summary of RPF Design Basis Events and ESF Provided for Mitigation,” indicate 

that the confinement systems for the hot cell and the radiological integrated control system 

(RICS) are considered safety-related systems, structures and components (SSCs). In order to 

assess whether SHINE’s radiation monitoring systems are adequately designed to remain 

available and reliable for the engineered safety features, in RAI 11.1-19 (Reference 17), the 

staff asked the applicant to: (1) clarify whether the items used for the RICS for the hot cells and 

other potentially high radiation areas are safety-related SSCs, and (2) demonstrate that 

radiation monitors (e.g., CAMS and RAMS) used as SSCs or for SSCs have appropriate 

controls (e.g., management measures) to ensure they remain available and reliable.

In response to RAI 11.1-19 (Reference 17), the applicant stated the RICS initiates engineered 

safety features (ESF) actuation for RPF hot cells and other isolable areas (e.g., noble gas 

shielded cell, RVZ2 isolation) that require isolation upon measured parameters exceeding 

setpoints as determined in the safety analysis. Safety-related confinement isolation actuation 

by RICS is described in PSAR Section 6b.2.1. SHINE also stated that RAMS is a safety-related 

system and the components of RAMS necessary for the RICS safety-related confinement 

isolation function are safety-related. However, SHINE has not classified the CAMS as safetyrelated since it is not credited with providing safety-related information for confinement isolation 

actuation. SHINE revised PSAR Sections 7a2.7.4.3 and 7b.1.3 of the PSAR to remove the 

reference to CAMS providing input to RICS for ESF functions. The staff finds the response 

clarifies the classification and function of the RICS, RAMS and CAMS, to meet the acceptance 

criteria in NUREG-1537 Section 11.1.4.

On the basis of its review, the staff has determined that the level of detail provided on radiation 

monitoring and surveying satisfies the applicable acceptance criteria of NUREG-1537, Part 2, 

Section 11.1.4, allowing the staff to make the following relevant findings: (1) the fixed and 

portable equipment used for radiation monitoring and sampling inside the facility are appropriate 

for the tasks needed to be performed; (2) the general types of monitoring and surveillance 

equipment appear appropriate to the facility; and (3) the commitments to implement a program 

consistent with the Regulatory Guides noted above give reasonable assurance that radioactive 

material and associated radiation exposures will be detected, monitored, and sampled 

consistent with 10 CFR Part 20 requirements and the facility ALARA program.
Radiation Protection Program and Waste Management

11-25

Therefore, the staff finds that the design of radiation monitoring and surveying provisions is 

sufficient and meets the applicable regulatory requirements and guidance for issuance of a 

construction permit in accordance with 10 CFR 50.35 and 50.40.

Radiation Exposure Control and Dosimetry

The staff evaluated the sufficiency of the radiation exposure control and dosimetry provisions, 

as described in SHINE PSAR Section 11.1.5, “Radiation Exposure Control and Dosimetry,” 

using the guidance and acceptance criteria from Section 11.1.5, “Radiation Exposure Control 

and Dosimetry,” of NUREG-1537, Part 2 and the ISG Augmenting NUREG-1537, Part 2. 

Consistent with the review criteria of NUREG-1537, Part 2, Section 11.1.5, the staff examined 

the facility exposure control and dosimetry programs for both external exposures and internal 

exposures to facility personnel, the environment, and the public to confirm that plans and the 

bases of procedures for the control of external dose to workers and the public consider 

equipment and equipment design, shielding, radiation monitors and alarms, personnel 

protective equipment, and external radiation monitoring dosimetry. The staff also considered 

whether procedures for the control of internal exposure consider equipment and equipment 

design, engineered controls, personnel protective equipment, radiation monitors, alarms and 

samplers, bioassay methods, frequency, and action levels, and the models and methods used 

for internal dose evaluation. The staff reviewed the engineered controls used to ensure 

radiation protection safety for each of the sources of radiation and radioactive material 

described in Section 11.1.1. The staff considered whether radiation protection measures have 

been implemented for sources of radiation and radioactive material. The staff confirmed that 

the radiation dose limits and bases are identified and the plans and programs to control doses 

are documented. The staff reviewed the descriptions of facility exposure conditions and 

methods used to derive administrative radiation dose limits. The staff evaluated whether the 

radiation protection engineered controls (e.g., the provisions of shielding, ventilation systems, 

remote handling systems) have been designed to reduce the potential for uncontrolled exposure 

or release and have been incorporated in the facility. The staff also considered how records will 

be kept to establish the conditions under which individuals were exposed to radiation. 

SHINE PSAR, Section 11.1.3, “ALARA Program,” states, in part, that the “ALARA concept is 

also incorporated into the design of the facility. The plant is divided into radiation zones with 

radiation levels that are consistent with the access requirements for those areas. Areas where 

on-site personnel spend significant amounts of time are designed to maintain the lowest dose 

rates reasonably achievable.” However, the staff determined that additional information was 

needed on the radiation zones to determine their consistency with ALARA. Therefore, in RAI 

11.1-4 (Reference 14), the staff asked the applicant to provide the radiation zone designations 

based on a consideration of neutron and gamma dose rates for locations that could be 

occupied, as well as the unrestricted environment as referenced in SHINE PSAR, 

Section 4a2.5.4. 

In response to RAI 11.1-4 (Reference 21), the applicant stated that it will use radiation area 

designations, as defined in 10 CFR 20, including consideration for neutron and gamma dose 

rates: unrestricted area, radiation areas, high radiation areas (HRAs), and very high radiation 

areas (VHRAs). The applicant further stated that the facility will be designed and constructed so 

that the measurable dose rate in the normally occupied and unrestricted area due to activities at 

the plant will be less than the limits of 10 CFR 20.1301(a)(2). The staff finds this response 

provides zone designations based on a consideration of neutron and gamma dose rates 

consistent with ALARA, and is therefore acceptable.
Radiation Protection Program and Waste Management

11-26

The regulations in 10 CFR 20.1902, “Posting requirements,” define the manner in which various 

radiological control areas should be demarcated. Included therein are requirements for 

Radiation Areas, High Radiation Areas, Very High Radiation Areas and Airborne Radioactivity 

Areas. SHINE PSAR, Section 11.1.5.1.1, “Radiological Zones,” Item b, “Restricted Area,” 

defines the types of restricted areas to be used for the purpose of radiological control. All of the 

posting requirements noted above have been included, except for a Very High Radiation Area.

Therefore, in RAI 11.1-5 (Reference 14), the staff asked the applicant to provide either: (a) a 

commitment that all Very High Radiation Areas included in the plant design will meet the 

requirements of 10 CFR Part 20, Subpart G, “Control of Exposure From External Sources in 

Restricted Areas,” or (b) Provide a basis for not including Very High Radiation Areas in the plant 

design (i.e., why such controls will not be necessary).

In response to RAI 11.1-5, the applicant stated that, in addition to those types of restricted areas 

defined in Subsection 11.1.5.1.1.b of the PSAR, very high radiation areas included in the facility

design will be posted in accordance with the requirements of 10 CFR 20. Specifically, very high 

radiation areas will meet the requirements of 10 CFR 20, Subpart G. SHINE updated the PSAR 

to include a definition of very high radiation areas in the list of restricted area types provided in 

Subsection 11.1.5.1.1.b. The staff finds this response is consistent with the requirements of 

10 CFR 20.1902, and is, therefore, acceptable.

SHINE PSAR 11.1.5.1.1, (page 11-19) “Radiological Zones,” describes radiation zones that 

have varied definitions and span of control. However, the NRC staff determined additional 

information was needed to understand how these radiological zones operate and would be used 

to: (1) control the spread of contamination, (2) control personnel access to avoid unnecessary 

exposure of personnel to radiation, and (3) control access to radioactive sources present in the 

facility. Therefore, in RAI 11.1-20 (Reference 17), the staff asked the applicant to provide 

additional information describing how the radiological zones are defined, how they work, how 

each zone is physically separated from other zones, and how the zones are maintained.

In response to RAI 11.1-20 (Reference 26), the applicant referenced the response to 

RAI 9a2.1-3, which provides additional information describing how the RCA ventilation zones 

are defined, how they work, how each zone is physically separated from other zones, and how 

the zones are maintained. Additionally, the applicant referenced PSAR Subsection 11.1.5.1.1, 

which describes radiation areas in the RCA with respect to varying radiation levels and varying 

contamination levels. SHINE also referenced its previous responses to RAIs 11.1-1 and 11.1-4 

for additional information on anticipated radiation areas and airborne radioactive material 

concentration zones (Reference 14). The staff finds this response describes how radiological 

zones are defined and would operate, and is therefore acceptable.

SHINE PSAR 11.1.5.2, “Access and Egress Control,” refers to active and passive engineered 

safeguards to control access to high radiation areas. However, the NRC staff determined that 

additional information was needed to determine the adequacy of the design of entry control 

devices to alert workers to, or prevent unauthorized entry to specified radiation areas, as 

appropriate. Therefore, in RAI 11.1-21 (Reference 17), the staff asked the applicant to: (a) 

provide a description of the active and passive safety systems that are used to control access to 

high radiation areas; and (b) clarify whether the “engineered safeguards” discussed in PSAR 

Section 11.1.5.2, are security-related, consistent with the guidance in NUREG-1537, 

Section 12.8, “Security Planning.”
Radiation Protection Program and Waste Management

11-27

In response to RAI 11.1-21(a) (Reference 26), the applicant stated that active and passive 

safety features will be provided to control access to high radiation areas in accordance with 

10 CFR 20.1601. These safety features include: personnel access door interlocks, audible and 

visual warnings, and shielding in the form of engineered physical barriers. The applicant 

revised PSAR Section 11.1.5.2 to include the safety features used to control access to high 

radiation areas described above. 

In response to RAI 11.1-21(b), the applicant referenced PSAR Section 11.1.5.2, which states:

Because there are high radiation areas in the facility, access to those areas is 

physically prevented due to radiation level. Access control is by a combination of 

administrative methods and active as well as passive engineered safeguards.

The applicant stated that the term “engineered safeguards” discussed above is not 

security-related, consistent with the guidance provided in NUREG-1537 Section 12.8, 

Regulatory Guide 5.59 (Reference 56), and Regulatory Issue Summary 2005-31, “Control of 

Security-Related Sensitive Unclassified Non-Safeguards Information Handled by Individuals, 

Firms, and Entities Subject to NRC Regulation of the Use of Source, Byproduct, and Special 

Nuclear Material” (Reference 89). The applicant further stated that the access control program, 

described in PSAR Section 11.1.5.2, ensures that: (a) signs, labels, and other access controls 

are properly posted and operative; (b) restricted areas are established to prevent the spread of 

contamination and are identified with appropriate signs; and (c) step-off pads, change facilities, 

protective clothing facilities, and personnel monitoring instruments are provided in sufficient 

quantities and locations.

The staff finds this response provides a description of the active and passive safety systems 

used to control access to high radiation areas and clarifies whether the “engineered safeguards” 

discussed in PSAR Section 11.1.5.2, are security-related, and is therefore acceptable. 

SHINE PSAR Section 9a2.1.1, (page 9a2-2) “Radiologically Controlled Area Ventilation 

System,” indicates the automatic cell ventilation dampers are safety-related. However, the NRC 

staff determined that additional information was needed to determine the adequacy of the 

design basis for the SHINE automatic cell ventilation dampers to ensure ALARA considerations 

are maintained. Therefore, in RAI 11.1-22(a) (Reference 17), the staff asked the applicant to 

identify the management measures required to ensure the safety-related dampers remain 

available and reliable to ensure radiation doses are maintained ALARA and within regulatory 

limits.

In response to RAI 11.1-22(a) (Reference 26), the applicant stated that isolation damper 

operability will be controlled by TS, as specified by Item 3.5 of PSAR Table 14a2-1. SHINE

further stated that its Quality Assurance Program, Preventive Maintenance Program, and TS 

surveillance activities will ensure the dampers remain available and reliable to ensure radiation 

doses are maintained ALARA and within regulatory limits.

The staff finds this response provides a design basis for the SHINE automatic cell ventilation 

dampers to ensure ALARA considerations are maintained, and is therefore acceptable. The 

staff will confirm that the final design conforms to this design basis during the evaluation of 

SHINE’s FSAR.

SHINE PSAR Section 9a2.1.1, (page 9a2-3) “Radiologically Controlled Area Ventilation 

System,” indicates that flow control valves will maintain constant pressure for the fume hoods. 

However, the NRC staff determined that additional information was needed to determine that 
Radiation Protection Program and Waste Management

11-28

the appropriate minimum pressure gradient will be maintained across the fume hood threshold. 

Therefore, in RAI 11.1-22(b) (Reference 17), the staff asked the applicant to demonstrate that a 

minimum pressure gradient will be maintained across the fume hood threshold consistent with 

guidance in Regulatory Guide 8.24, “Health Physics Surveys During Enriched Uranium-235 

Processing and Fuel Fabrication” (Reference 83).

In response to RAI 11.1-22(b) (Reference 26), the applicant stated it would follow the guidance 

provided in Regulatory Guide 8.24 for fume hood operations and maintenance involving 

uranium-235 processing. Issues identified during fume hood surveys, operations, and 

maintenance would be placed in the SHINE Corrective Action Program. SHINE would terminate 

fume hood work if parameters are found to be below acceptable levels, as specified in 

Regulatory Guide 8.24.

The staff finds this response discusses how the minimum pressure gradient will be maintained 

across the fume hood threshold consistent with Regulatory Guide 8.24.

The ISG Augmenting NUREG-1537, Part 2, Section 11.1, “Radiation Protection,” states, in part:

[I]ndividuals who are not workers, as defined in 10 CFR 70.4, may be permitted 

to perform ongoing activities...in the controlled areas if the licensee...[p]rovides 

training that satisfies 10 CFR 19.12(a)(1)-(5) to these individuals and ensures 

that they are aware of the risks associated with accidents involving the licensed 

activities as determined by the ISA...

While SHINE PSAR Section 13b.2.1.2, “Identification of Initiating Events and Causes,” 

discusses a rupture of five noble gas storage tanks, it does not identify the credible accident 

events that could initiate this accident sequence. Therefore, in RAI 11.1-23 (Reference 17), the 

staff asked the applicant to identify the potential credible accident sequences that could result in 

the radiological maximum hypothetical accident (MHA). The staff asked the applicant to provide 

sufficient information to describe the initiating events and demonstrate that the consequences 

are calculated for both the credible unmitigated conditions (without SSCs) and mitigated 

conditions (with SSCs). Furthermore, in RAI 11.1-24, the staff requested that SHINE 

recalculate the MHA for both the worker and the public excluding mitigation, as well as justify 

the assumptions use to mitigate the MHA.

In response to RAI 11.1-23 (Reference 17), the applicant responded that they have identified a 

MHA consistent with the guidance provided in Parts 1 and 2 of NUREG-1537, and Parts 1 and 2 

of the ISG augmenting NUREG-1537. The guidance on the MHA is primarily described in 

Chapter 13 of NUREG-1537 and Sections 13a2 and 13b of the ISG. In Section 13a2 of Part 1

of the ISG, it is stated that the MHA selected should bound all credible potential accidents at the 

facility and that the MHA may be a non-mechanistic failure assumed to establish outer limit 

consequence, but the scenario need not be entirely credible. In Section 13b.1.2 of Part 2 of the 

ISG, under the evaluation findings for the MHA, it is stated that the MHA is not considered a 

credible event for the facility. The applicant considers the rupture of five noble gas storage 

tanks simultaneously to not be an entirely credible event and is a means to establish an outer 

limit consequence. Therefore, the applicant did not identify potential credible accident 

sequences that could result in the radiological MHA. SHINE provided the mitigated dose 

consequences for the MHA in Subsection 13b.2.1.7 of the PSAR. The applicant did not 

calculate the MHA dose consequences for both the worker and the off-site public excluding 

mitigation because there is no regulatory requirement to do so. In addition, the SHINE 

response to RAI 13b.1-3 (Reference 25) provides a detailed accident sequence description for 
Radiation Protection Program and Waste Management

11-29

the MHA, from the initiating event through the sequence’s mitigated consequences. The staff 

finds this response adequately describes the MHA, and is therefore acceptable. Additional 

analysis of the MHA is provided in Chapter 13, “Accident Analysis,” of this SER.

SHINE PSAR Section 13b.2.1.1, (page 13b-5) “Initial Conditions and Assumptions,” identifies 

systems that are mitigative without designating them as safety-related structures, systems, and 

components. Therefore, in RAI 11.1-25 (Reference 17), the staff asked the applicant to 

designate all mitigative or preventive systems relied on as safety-related structures, systems, 

and components, and designate appropriate management measures. The staff asked the 

applicant to provide a commitment to evaluate all credible accidents under unmitigated 

conditions and implement safety-related SSCs, as applicable, and management measures to 

ensure intermediate and high consequence events comply with the performance requirements 

of 10 CFR 70.61 (or equivalent).

In response to RAI 11.1-25 (Reference 26), the applicant stated the SSCs which are required to 

mitigate the MHA described in PSAR Section 13b.2.1 to meet the dose requirements specified 

in 10 CFR 20 include RVZ1 (including isolation dampers), RVZ2, the structure and confinement 

seals of the noble gas shielded cell (as part of the confinement boundary), and the RAMS. As 

described in the response to RAI 13b.1-3, the SSCs SHINE credited to perform a preventative 

function are the process tanks and piping (i.e., the integrity of the NGRS storage tanks and 

interconnecting piping), and the administrative control credited with helping to prevent this event 

(i.e., Conduct of Operations Program). SHINE stated that safety-related SSCs and 

administrative controls required to prevent and mitigate the events are described in the 

response to RAI 13b.1-1 (Reference 21). The staff finds this response designates mitigative 

and preventive systems relied on as safety-related SSCs, and is therefore acceptable.

In summary, the applicant’s PSAR and supplemental information provided in response to the 

RAI, provides sufficient information for the staff to determine that the proposed definitions for 

Unrestricted Areas, Restricted Areas, and Controlled Areas are appropriate and consistent with 

10 CFR 20. The staff was also able to determine that the definition of Radiation Area and other 

area posting requirements contained in 10 CFR 20.1902 have been met. SHINE has committed 

to implement the requirements of Subpart G of 10 CFR 20 for HRAs and VHRAs that will be 

included in facility design.

The applicant has proposed an approach to the control of external exposures that includes a 

trigger point for investigating off-normal exposures at 25 percent of their administrative limit 

(10 percent of the occupational limits in Subpart C of 10 CFR 20). The investigation level thus 

becomes: 5 rem/yr x 10% x 25% = 125 mrem. The investigation process that is proposed by 

SHINE when this trigger point is reached should ensure that an adequate review process takes 

place and lessons-learned developed. The staff qualitatively determined that this investigative 

process was adequate.

Regarding internal exposure assessment, the applicant proposes to use a mixture of air 

sampling and bioassay determinations that are prescribed by 10 CFR 20.1204. The staff has 

determined that this process, coupled with the necessary sampling, monitoring, and analysis 

processes, should be adequate for quantification of internal exposure. The staff notes, 

however, that in order to implement the aspects of internal dose evaluations that are described 

in PSAR Sections 11.1.5.6.c – 11.1.5.6.e. Prior to issuing the operating license NRC approval 

is required as stated in 10 CFR 20.1204(c).
Radiation Protection Program and Waste Management

11-30

Additionally, the staff reviewed the support facilities (locker and change rooms, first aid area, 

and a personnel decontamination area) proposed by SHINE, which should be adequate for

operational needs.

On the basis of its review, the staff has determined that the level of detail provided on radiation 

exposure control and dosimetry provisions, is adequate and supports the preliminary design and 

satisfies the applicable acceptance criteria of NUREG-1537, Part 2, Section 11.1.5, allowing the 

staff to make the following relevant findings: (1) program for posting and access control 

regarding Restricted Area, Controlled Area, and Unrestricted Area definitions, proposed access 

controls, and area radiological posting methodology is sufficient to meet the requirements of 

10 CFR 20; (2) proposed dosimetry program meets the requirements of 10 CFR Part 20 and is 

acceptable, provided that prior NRC approval is received for internal dose evaluations that use 

the provisions of 10 CFR Part 20.1204(c); and (3) the provisions incorporated for locker and 

change rooms, a decontamination facility, and storage areas for radiation protection equipment 

and supplies, although discussed in conceptual terms, are considered acceptable for design 

purposes.

Therefore, the staff finds that the facility design features for radiation exposure control and 

dosimetry provisions meets the applicable regulatory requirements and guidance for issuance of 

a construction permit in accordance with 10 CFR 50.35 and 50.40. Further technical or design 

information required to complete the safety analysis may reasonably be left for later 

consideration. 

Contamination Control

The staff evaluated the sufficiency of the radiation exposure control and dosimetry provisions, 

as described in SHINE PSAR Section 11.1.6, “Contamination Control Equipment and Facility 

Layout General Design Considerations for 10 CFR 20.1406,” using the guidance and 

acceptance criteria from Section 11.1.6, “Contamination Control,” of NUREG-1537, Part 2. 

Consistent with the review criteria of NUREG-1537, Part 2, Section 11.1.6, the staff considered 

the elements of the contamination control program to ensure: 

(1) The program scope demonstrates understanding of problems caused by radioactive 

contamination.

(2) Procedures will be established to prevent radioactive contamination.

(3) The bases of procedures show that routine monitoring of locations, equipment, and 

personnel for contamination will be established and maintained.

(4) Bases of procedures show that no materials, equipment, or personnel will be permitted 

to leave an area known to be or suspected of being contaminated without being 

appropriately monitored.

(5) Contamination control program includes provisions to avoid, prevent, and remedy the 

occurrence and the spread of contamination.

(6) Contamination control training is established as part of comprehensive radiation 

protection and radioactive waste management training, as needed.
Radiation Protection Program and Waste Management

11-31

(7) Contamination control program includes provisions for recordkeeping in accordance 

with 10 CFR Part 20 regarding occurrence and spread of contamination, sufficient in 

content and retention for cleanup of contamination, maintenance, and planning for 

eventual decommissioning of the facility.

The staff notes that the design features described in PSAR Section 11.1.6 emphasized 

containment of radioactive material and leak detection. Design features included in SHINE 

PSAR Section 11.1.3 included examples that would also assist in meeting the requirements of 

10 CFR 20.1406. Specifically, PSAR Section 11.1.3 described features that: (1) allowed 

draining, flushing, and decontaminating equipment and piping; and (2) design of equipment to 

minimize the creation and buildup of radioactive material and to ease flushing of crud traps. 

The applicant proposed procedures to be used for contamination control and monitoring of 

personnel and equipment leaving the Restricted Area is consistent with industry practice and 

should enable an adequate contamination control program to be implemented. The staff has 

determined that the design features related to radioactive material containment and periodic 

decontamination when necessary, together with the proposed contamination control and 

monitoring program, are acceptable.

On the basis of its review, the staff has determined that the level of detail provided on 

contamination control satisfies the applicable acceptance criteria of NUREG 1537, Part 2, 

Section 11.1.6, allowing the staff to make the following relevant finding: the description and 

level of detail on the contamination control program will acceptably meet the requirements of 

10 CFR 20.1406.

Therefore, the staff finds that the design of radiation monitoring and surveying provisions meets 

the applicable regulatory requirements and guidance for issuance of a construction permit in 

accordance with 10 CFR 50.35

Environmental Monitoring

The staff evaluated the sufficiency of the radiation exposure control and dosimetry provisions, 

as described in SHINE PSAR Section 11.1.7, “Environmental Monitoring,” using the guidance 

and acceptance criteria from Section 11.1.7, “Environmental Monitoring,” of NUREG-1537, 

Part 2 and the ISG Augmenting NUREG-1537, Part 2. 

Consistent with the review criteria of NUREG-1537, Part 2, Section 11.1.7, the staff evaluated 

whether the PSAR section discussed the environmental quality commitments that the program 

should address and the standards that were used in development of the program. The staff 

reviewed the methods used to establish the preoperational baseline conditions. The staff 

performed a qualitative review to evaluate the sufficiency of the methods and techniques to 

sample and analyze the radiological effect of facility operation. The staff considered if the 

environmental monitoring program would be capable of detecting and assessing a significant 

radiological impact on the environment from the facility.

SHINE PSAR, Section 11.1.7.2.2.1, “Air Sampling Locations,” discusses the proposed air 

monitoring program. When discussing the equipment that will be used for air sampling, the 

applicant uses the term CAM (continuous air monitor). The conventional use of the term 

“continuous air monitor” denotes equipment that both samples and quantifies the activity on the 

sample media (i.e., real-time monitoring). Normally, CAMS are not used for such purposes and 

the NRC guidance document, NUREG-1301, “Offsite Dose Calculation Manual Guidance: 

Standard Radiological Effluent Controls for Pressurized Water Reactors” (Reference 90), that 
Radiation Protection Program and Waste Management

11-32

the applicant cites, does not specify CAMs for environmental air sampling. Therefore, in 

RAI 11.1-6 (Reference 14), the staff asked the applicant to clarify whether the term “air 

monitoring” is intended to refer to sample collection followed by laboratory analysis or real-time 

air monitoring.

In response to RAI 11.1-6 (Reference 21), the applicant stated that it inappropriately used the 

term “CAM” to refer to a continuous air sampler in PSAR Subsection 11.1.7.2.2.1. SHINE will 

employ continuous air samplers at the stated locations, with the samples collected and analyzed 

in a laboratory. SHINE corrected the terminology in PSAR Subsection 11.1.7.2.2.1, 

Table 11.1-8, and Figure 11.1-3. 

SHINE PSAR, Section 11.1.7.2.3, “Ingestion Pathway (Biota Monitoring),” discusses the 

proposed monitoring program for the ingestion pathway. This section notes that because 

radioiodine and particulate activity is not expected to be present in measureable quantities in 

effluent releases, biota sampling will only be included if certain conditions are met. These 

conditions include: (a) the presence of radioiodine or particulates on an environmental air 

sample, or (b) effluent releases of radioiodine or particulates that would result in a dose at the 

property line of 1 millirem/year or more. The PSAR also notes that dairy production takes 

places 0.5 miles from the facility and goat milk production occurs 0.7 miles from the facility. 

Given the presence of cow and goat milk production so close to the SHINE facility, it is apparent 

that routine milk sampling as part of the radiological environmental monitoring program is 

warranted because: (1) the proposed sampling of effluents and the environment may not result 

in timely recognition of an environmental impact issue if an off-normal release occurs in the 

beginning of a sample period (presumably a one-week interval), considering the remaining 

collection period and subsequent laboratory analysis; (2) milk, especially goat milk, is a more 

sensitive indicator of radioiodine impact on the environment; and (3) routine milk sampling could 

also demonstrate the adequacy of inplant controls. Beyond the regulatory requirements aspect, 

milk pathway sampling provides an opportunity to establish a relationship with neighboring 

dairies that can foster confidence in plant operations.

Therefore, in RAI 11.1-7 (Reference 14), the staff asked the applicant to provide additional 

information regarding exclusion of ingestion pathway monitoring and determine whether it is 

appropriate to add milk sampling to the radiological environmental monitoring program. This 

RAI was asked to satisfy the acceptance criteria of NUREG-1537, Part 2, Section 11.1.7, 

“Environmental Monitoring,” Acceptance Criteria, which states that “[t]he methods and 

techniques to sample and analyze the radiological effect of facility operation should be 

complete, applicable, and of sufficient validity that the environmental impact can be 

unambiguously assessed.”

In response to RAI 11.1-7 (Reference 20), the applicant determined it is appropriate to add 

routine milk sampling to the environmental monitoring program for a 5 year monitoring period. 

Continued sampling beyond the initial 5 year period will be determined based upon the results 

of the sampling program. The staff finds this response provides an appropriate method to 

sample and analyze the radiological effect of facility operation to meet the acceptance criteria in 

NUREG-1537, Part 2, Section 11.1.7.

The large number (40) of direct exposure monitoring stations (e.g., thermoluminescent 

dosimeter) recommended in NRC guidance documents for nuclear power plants is noted in 

SHINE PSAR, Section 11.1.7.2.1, “Direct Radiation Monitoring,” as well as a statement 

regarding why that number of monitoring stations does not appear warranted for the SHINE 

facility. As a result, the applicant proposed nine direct radiation-monitoring locations, based on 
Radiation Protection Program and Waste Management

11-33

the smaller source term compared to nuclear power plants. Only four direct monitoring 

locations were proposed at the site boundary (north, east, south, and west). However, 

additional information was needed for the NRC staff to determine whether the number of direct 

monitoring locations should be based on source term alone or whether consideration should 

also be given to the variability of wind direction and the expected “signal-to-noise ratio” (plant 

contribution versus background). Additional direct monitoring stations would provide more 

statistical power to the analysis, enhancing the ability to monitor the impact on the environment 

from the SHINE facility. The staff notes that such a relatively small number of monitoring 

locations decreases the probability of detecting the impact of effluent releases associated with 

normal and off-normal operations, and accidents.

Therefore, in RAI 11.1-8 (Reference 14), the staff asked the applicant to provide additional 

information further justifying use of only four direct monitoring locations, or propose additional 

monitoring locations at the site boundary and special interest areas, such as population centers 

and nearby residences and schools.

In response to RAI 11.1-8 (Reference 20), SHINE proposed adding 15 direct 

radiation-monitoring stations to the 9 proposed in PSAR Subsection 11.1.7.2.1, for a total of 24 

direct radiation-monitoring stations. The applicant stated PSAR Figure 11.1-3 and Table 11.1-8 

will be updated in the FSAR to include the additional direct radiation-monitoring stations 

described above. Following the receipt of SHINE’s FSAR, staff will confirm that SHINE has 

fulfilled this commitment.

The proposed Radiological Environmental Monitoring Program (REMP), as described in the 

PSAR and amended by the RAI responses cited above, is generally consistent with NRC 

guidance that includes the following (as principal examples):

• Regulatory Guide 4.1, “Radiological Environmental Monitoring For Nuclear Power 

Plants” (Reference 91).

• Regulatory Guide 4.15, “Quality Assurance for Radiological Monitoring Programs 

(Inception Through Normal Operations to License Termination)—Effluent Streams and 

the Environment (Reference 92).

• NUREG-1301, “Offsite Dose Calculation Manual Guidance: Standard Radiological 

Effluent Controls for Pressurized Water Reactors,” (and the companion NUREG-1302 on 

the same subject for Boiling Water Reactors) (Reference 90).

The term “generally consistent” is used due to the fact that all of the above-cited references 

relate to the development and conduct of REMPs for nuclear power plants. As recognized by 

the applicant, many of the REMP elements had to be adjusted to be more applicable to SHINE’s 

medical radioisotope production facility. The staff finds these adjustments, as noted in the 

above discussion, to be acceptable.

On the basis of its review, the staff has determined that the level of detail provided on 

environmental monitoring is adequate for the preliminary design and satisfies the applicable 

acceptance criteria of NUREG 1537, Part 2, Section 11.1.7, allowing the staff to make the 

following relevant findings: (1) the environmental monitoring program described is appropriate 

to the facility and its projected impact; and (2) the proposed REMP is consistent with the 

applicable portions of the aforementioned regulatory guidance.
Radiation Protection Program and Waste Management

11-34

Therefore, the staff finds that the design of environmental monitoring is sufficient and meets the 

applicable regulatory requirements and guidance for issuance of a construction permit in 

accordance with 10 CFR 50.35 and 50.40.

Radioactive Waste Management Program

The staff evaluated the sufficiency of the radioactive waste management program, as described 

in SHINE PSAR Section 11.2.1, “Radioactive Waste Management Program,” using the guidance 

and acceptance criteria from Section 11.2.1, “Radioactive Waste Management Program,” of 

NUREG-1537, Part 2 and the ISG Augmenting NUREG-1537, Part 2. 

Consistent with the review criteria of NUREG-1537, Part 2, Section 11.2.1, the staff evaluated 

how the radioactive waste management program fits into the facility’s overall management 

structure, how such wastes are identified and segregated effectively, how the waste 

management organization, with support from the radiation protection organization will ensure 

that radioactive wastes are continuously controlled from formation to ultimate safe disposal, and 

what organizational entities are assigned responsibilities in the radioactive waste management 

program.

The staff review of PSAR Section 11.2.1 included review of PSAR Chapter 12, “Conduct of 

Operations” to assure consistent integration, and review of applicable parts of Sections 9b to 

assure the systems design included features needed to sample waste streams to obtain the 

information required by the regulations. 

The staff notes the introductory paragraph in PSAR Section 11.2 contains a commitment to 

comply with all applicable local and national regulations for managing radioactive wastes. This 

commitment was supplemented by SHINE’s response to RAI 11.2-6, which provided a list of 

federal regulations and regulatory guidance to be followed by SHINE. The staff has determined 

that the waste management program described in SHINE PSAR Section 11.2.1 describes a 

sufficient administrative structure to assure releases of gaseous and solid wastes are in 

accordance with the regulations. The requirements contained in 10 CFR 20, Subpart K focus 

primarily on the information needed to adequately identify and characterize radioactive material 

for transportation and disposal. PSAR Section 9b.7.3.1.2 identifies sampling capabilities 

needed to obtain data required by the regulations. PSAR Section 11.2.1.3 assigns 

responsibilities to Waste Management/Operations Management for maintaining working 

knowledge of waste disposal requirements and for the procedures and processes needed to 

ship wastes for disposal. 

PSAR Section 11.2.1 contains a commitment to develop an official charter describing the 

authority, duties, and responsibilities of personnel in the waste management organization for the 

FSAR. PSAR Chapter 12, Appendix 12 D commits to describing the Conduct of Operations 

program in the FSAR. Following the receipt of SHINE’s FSAR, staff will confirm that this 

information has been provided.

SHINE PSAR Section 11.1.1.2 (page 11-4), “Liquid Radioactive Sources,” indicates that solid 

waste will be sent to disposal facilities. However, the NRC staff determined that additional 

information was needed to determine the adequacy of SHINE’s management of radioactive 

wastes. Therefore, in RAI 11.2-7 (Reference 17), the staff asked the applicant to provide 

additional information indicating that these disposal facilities will have appropriate licenses for 

managing radioactive wastes (i.e., licensed disposal facilities).
Radiation Protection Program and Waste Management

11-35

In response to RAI 11.2-7 (Reference 26), the applicant stated that the disposal facilities 

referred to in PSAR Subsection 11.1.1.2 will have appropriate licenses for managing radioactive 

waste (i.e., licensed disposal facilities). The staff finds this response adequately demonstrates 

a commitment to comply with applicable regulations for managing radioactive wastes, and is 

acceptable.

SHINE PSAR Sections 11.2.3.1, 11.2.3.2, and 11.2.3.3, describe the control of solid, liquid and 

gaseous waste streams. However, the NRC staff determined that additional information was 

needed to determine the adequacy of SHINE’s control of waste streams. Therefore, in RAI 

11.2-8 (Reference 17), the staff asked the applicant to provide a description of the survey or 

monitoring equipment [e.g., continuous air monitoring system (CAMS) and radiation area 

monitoring system (RAMS)] and program that will be used to ensure wastes remain in these 

designated controls/processes and identify any loss of control or unplanned releases.

In response to RAI 11.2-8 (Reference 26), the applicant stated that the CAMS equipment is 

described in PSAR Section 7a2.7.4.1, and the RAMS equipment is described in PSAR Section 

7a2.7.4.2. SHINE stated that its RP Program will ensure wastes remain in these designated 

controls/processes, and identify any loss of control or unplanned releases. The staff finds this 

response provides an adequate description of how waste streams will be controlled. The staff 

will review SHINE’s RP Program to verify SHINE’s waste stream controls in the FSAR.

On the basis of its review, the staff has determined that the level of detail provided on the 

radioactive waste management program supports the preliminary design and satisfies the 

applicable acceptance criteria of NUREG 1537, Part 2, Section 11.2.1, allowing the staff to 

make the following relevant findings: (1) personnel will be appropriately structured to perform 

functions under the program in accordance with the requirements; and (2) facility systems are 

designed in a manner that will provide the capability to obtain the data needed to comply with 

the requirements.

Therefore, the staff finds that the radioactive waste management program meets the applicable 

regulatory requirements and guidance for issuance of a construction permit in accordance with 

10 CFR 50.35 and 50.40. Further evaluation of the waste management program and its 

integration into the overall conduct of operations will occur following the receipt of the FSAR 

submitted with the operating license application.

Radioactive Waste Controls

The staff evaluated the sufficiency of the radiation exposure control and dosimetry provisions, 

as described in SHINE PSAR Section 11.2.2, “Radioactive Waste Controls,” using the guidance 

and acceptance criteria from Section 11.2.2, “Radioactive Waste Controls,” of NUREG-1537, 

Part 2 and the ISG Augmenting NUREG-1537, Part 2. 

Consistent with the review criteria in NUREG-1537, Part 2, Section 11.1.5, the staff examined 

how all processes and procedures that could produce radioactive waste material will be 

evaluated. The staff considered whether appropriate monitoring and sampling will be performed 

and sufficient analyses will be completed to assess the extent of the radiation exposure from 

waste products. The staff reviewed whether the applicant sufficiently described methods to: (1) 

avoid inadvertent exposure of personnel or uncontrolled escape of the radioactive materials; (2) 

define and maintain continuous control of radioactive materials that require treatment and 

management as waste; and (3) reduce the quantities of radioactive waste.
Radiation Protection Program and Waste Management

11-36

The staff notes the purpose of the SHINE facility is to produce Mo-99 by fissioning uranium in a 

liquid uranium sulfate solution and extracting Mo-99 from the resulting fission products. 

Because both the volume and the radioactivity content of fission products, other than Mo-99, far 

exceeds that of the Mo-99 product, waste management activities and control are an important 

aspects of the overall operation. Regarding waste minimization, review of PSAR Section 11.2.1 

confirms that waste minimization programmatic efforts are part of annual audits of the waste 

management program. The staff reviewed the description of the waste streams presented in 

SHINE PSAR Section 11.2.2.2 and the evaluations contained therein identifying the required 

capabilities for adequate packaging of the wastes for transportation and disposal. The 

evaluations of the systems generating these waste streams and processing them through 

packaging are presented in SER Chapters 4 and 9.

The Mo-99 extraction columns are a frequent (400 target solution volumes per year) and initially 

highly radioactive solid waste generated by the proposed SHINE facility. As a supplement to 

material presented in SHINE PSAR, Section 9b.7.2, “RCA Material Handling,” and Section 11.2, 

“Radioactive Waste Management,” additional information is needed on criteria for the handling 

of this waste stream and the handling of the extraction column in and from the supercells to the 

shielded vaults and further to packaging and shipping for disposal. This information is needed 

for the NRC staff to ascertain SHINE’s ability to meet the regulatory requirements regarding 

hazardous material identification in shipping papers (10 CFR Part 20, Subpart K, “Waste 

Disposal”), and conformance with ALARA goals.

Therefore, in RAI 11.2-1 (Reference 14), the staff asked the applicant to provide the following 

information so that staff could assess compliance with the ALARA requirement of 

10 CFR Part 20: 

(a) Describe the inlet and outlet connections of the Mo-99 columns that permit frequent 

remote replacement while providing leak-tightness and preventing the spread of 

contamination during replacement. Provide the estimated dose rate from an extraction 

column at time of removal and after 2 weeks storage in the supercell; 

(b) Provide information on the material handling methods of moving shielded containers of 

an extraction column from the supercell to the shielded vaults at the other end of the 

facility from the supercells. If this material handling includes movement by crane, 

include a load drop in the accident analyses or justify why such an event need not be 

considered; 

(c) Clarify how long extraction columns are maintained in shielded vault storage. SHINE 

PSAR, Table 11.2-3, “Waste Methodology for Columns,” says approximately 400 days of 

decay are required to be Class A; PSAR, Section 9b.7.5.4.2, “Solid Radioactive Waste 

Handling Hot Cell,” says they are transferred to the storage vault for an additional 6 

months.; 

(d) Provide information on the transfer of an extraction column into one of the six separate 

shielded storage vaults shown on figures presented in SHINE PSAR, Chapter 1, “The 

Facility”; and, 

(e) Clarify, whether there are any differences between the handling of the Mo-99 columns.

In response to RAI 11.2-1(a) (Reference 21), the applicant stated that:

The inlet and outlet connectors are a quick-disconnect style specifically designed 

for use with remote manipulators in hot cell environments. Radiation and wear-
Radiation Protection Program and Waste Management

11-37

resistant seals provide leak tightness. Automatic valves built into the connectors 

close when the connector is separated, which significantly reduces the leakage 

of contaminated fluids from the process lines and columns. As the target solution 

is washed from the extraction column (by an acid wash, water wash, and strip 

solution) prior to the column being removed, there will be significantly lower 

levels of contamination present in the column and lines during disconnection than 

during extraction steps. Means will be provided to capture the small leakage of 

liquid that will occur during the disconnection of the connectors. The estimated 

dose rate for an extraction column at the time of removal is approximately 6,700 

rem/hr at 3 feet unshielded. The peak dose rate drops to approximately 340 

rem/hr at 3 feet unshielded after 2 weeks of storage in the supercell.

In response to RAI 11.2-1(b) (Reference 21), the applicant stated that:

The material handling methods involved in the transfer of an extraction column 

from the supercell to the shielded vaults are described in Part d of the SHINE 

Response to this RAI. 

The applicant stated that they will ensure safe load handling guidance is applied to the 

movement, as described in the SHINE Response to RAI 9b.7-1.

In response to RAI 11.2-1(c) (Reference 21), the applicant stated that:

Following storage in the supercell for no less than two weeks after use, the 

extraction columns will be maintained in shielded vault storage for approximately 

six months. The columns will then be transferred to the solid radioactive waste 

handling hot cell for packaging in approved containers. The containers will be 

transferred to the Waste Staging and Shipping Building for storage until they reach 

the requirements for Class A waste and can be shipped for disposal. Preliminary 

calculations indicate that a total decay time of approximately 400 days will be 

needed for the columns to reach the requirements for Class A waste. At least two 

weeks of this time will be spent in the supercell, approximately six months in 

shielded vaults, and the remaining time (approximately 200 days) will be spent in 

the Waste Staging and Shipping Building.

In response to RAI 11.2-1(e), the applicant stated that it plans to perform the following steps for 

the transfer of an extraction column from a supercell to a shielded storage vault: 

After removing an extraction column from the process, it is decayed for a 

minimum of two weeks in the supercell on a decay storage rack. Several 

extraction columns that have decayed for a minimum of two weeks are planned 

to be transported out of the cell in one transfer to reduce personnel exposure and 

the number of transfer operations. The number of extraction columns transferred 

will be limited based on transfer container capacity. The transfer container will 

be shielded to ensure personnel doses are maintained ALARA and within 

procedural limits during the transfer.

When several extraction columns are to be transferred, a transfer container will 

be placed on a transfer cart. The radiation levels in the supercell will be checked 

to ensure they are below procedural limits that permit opening the supercell 

shield door. The shield door, which opens to the lower section of the extraction 
Radiation Protection Program and Waste Management

11-38

cell, will then be opened. The transfer cart will be moved into the extraction area 

of the supercell. The transfer container will then be raised to the transfer system 

hatch and sealed to reduce the potential for contamination of the lower section of 

the extraction cell.

The supercell shield door will then be closed, and the hatch will be opened. The 

supercell manipulators will be used to move several extraction columns to the 

transfer container and the hatch will be closed. The radiation levels in the 

supercell will be checked to ensure they are below procedural limits that permit 

opening the supercell shield door. The shield door will be opened, and the 

transfer container will be detached and lowered from the hatch. The transfer cart 

will then be removed from the supercell and the shield door will be closed. 

Before leaving the contaminated area boundary, the transfer cart and the exterior 

surfaces of the transfer container will be checked to ensure surface 

contamination is below procedural limits. If contamination is found, the transfer 

container and cart will be decontaminated in accordance with health physics 

procedures before being released. 

The transfer cart will then be moved to the shielded storage vault. Any checks 

required prior to removing the storage vault shield plug, such as radiation level, 

will be made and verified within procedural limits. The overhead crane will then 

be used to remove the shield plug. An engineered lifting device will then be used 

to lower the shielded container into the shielded cell.

The overhead crane will then be used to replace the shielded storage vault shield 

plug, and the transfer cart will be returned to its storage location.

In response to RAI 11.2-1(d), the applicant stated that all of the columns will be handled in the 

same manner, namely: (1) stored in the supercell for no less than 2 weeks after use; (2) 

transferred to the storage vault for additional decay time, currently planned for 6 months; (3) 

transferred to the solid radioactive waste handling hot cell in approved containers; and (4) 

transferred to the waste staging and shipping building prior to being shipped offsite.

The staff finds the information in the PSAR as supplemented by this response, complies with 

the requirements in 10 CFR Part 20, Subpart K and is consistent with SHINE’s commitment to 

ALARA and demonstrates an adequate methodology for a preliminary design. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

SHINE PSAR, Section 4b.4.1.1.4.1, “Uranyl Nitrate Preparation Process Sequence,” explains 

part of the process for reusing target solution and states that the solid salts discharged from the 

centrifuge are moved to solid radioactive waste packaging in a 55-gallon drum. PSAR, Section 

11.2.2.2.6, “Target Solution Clean-up,” identifies that this waste stream is Class B. There is no 

discussion of the radiation levels emanating from these drums, no discussion of sealing the 

drums during handling to prevent spills, and no discussion of design features implemented to 

assure doses to workers are ALARA during these evolutions. PSAR, Table 11.2-6, “Waste 

Methodology for [ ]” (the rest of the table name is withheld as proprietary information), identifies 

that the waste stream must be sampled for waste characterization prior to solidification, but 

there is no discussion of how this is accomplished in an ALARA manner.
Radiation Protection Program and Waste Management

11-39

Therefore, in RAI 11.2-2 (Reference 14), the staff asked the applicant to provide discussion of 

the design features and design review procedures used to assure that the ALARA 

considerations committed to in SHINE PSAR, Section 11.1.3, “ALARA Program,” are effectively 

implemented for each of the identified waste streams and the handling operations required 

during their processing.

In response to 11.2-2 (Reference 21), the applicant stated that PSAR Subsection 11.1.2.1 

discusses SHINE’s commitment to the implementation of an ALARA program. The applicant 

also provided the preliminary design features of the Uranyl Nitrate Preparation (UNP) waste 

streams. The applicant also stated they will more fully specify waste handling for the UNP 

subsystem with respect to design features used to assure that ALARA considerations are 

effectively implemented during detailed design, and provide those details in the FSAR. An IMR 

has been initiated to track the inclusion of this information in the FSAR. Further, the applicant 

states that while the SRWP system design has not been finalized, the design of the radiation 

shielding for tanks, walls, hot cells, and the drums will ensure the dose rates are within the 

regulatory limits of 10 CFR 20.1201 and 10 CFR 20.1301, and that the dose rates in normally 

occupied areas meet (to the extent practicable) the facility goal of 0.25 mrem/hr. These design 

features will also ensure that ALARA objectives to minimize exposure to facility workers during 

waste handling and transfer operations are met. Radiation monitors will be located at operations 

areas to detect and warn of changes in radiation levels. A design review of the final SRWP 

system design will be performed to ensure that transfer and processing of the sulfate sludge will 

be done in an ALARA manner. The design review will be proceduralized, and these procedures 

will evaluate general design considerations and methods to maintain radiation exposures 

ALARA consistent with the recommendations of Regulatory Guide 8.8. Following the receipt of 

SHINE’s FSAR, staff will confirm that these issues have been resolved.

The staff finds this response demonstrates an adequate methodology for a preliminary design. 

The staff will confirm that the final design conforms to this design basis during the evaluation of 

SHINE’s FSAR.

The staff identified some errors and inconsistencies regarding liquid waste quantities and 

generation in Tables 11.2-1 and 11.2-5 and, in RAIs 11.2-3 and 11.2-4 (Reference 14), asked 

the applicant to correct or justify the inconsistent values. In response to RAI 11.2-3 and 11.2-4, 

the applicant committed to revise Tables 9b.7-7, 11.2-1 and 11.2-5 with corrected values. 

Additionally, the applicant provided a liquid waste process flow diagram and discussed the liquid 

waste streams. SHINE has since updated the PSAR with a revised tables. The staff finds 

these responses demonstrate an adequate methodology for a preliminary design. The staff will 

confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

SHINE PSAR Chapter 11 states that disposal sites have established waste acceptance criteria. 

The inputs to the consolidated radioactive liquid waste tanks are a mixture of strong acids and 

bases, chemicals in solution, and water, all containing fission products. This chemical mixture is 

then concentrated through evaporation to reduce the volume of waste to be solidified for 

packaging and disposal. In RAI 11.2-5 (Reference 14), the staff asked the applicant to provide 

references that support the validity of the assumption that the evaporator concentrates of the 

consolidated liquid waste stream can be solidified on Portland cement to meet the waste 

acceptance criteria of the potential disposal sites.

In response to RAI 11.2-5 (Reference 26), the applicant stated that it plans to adjust the pH of 

the consolidated radioactive liquid waste prior to evaporation and solidification using Portland 
Radiation Protection Program and Waste Management

11-40

cement as the solidification agent. As discussed in SHINE’s RAI response, the Electric Power 

Research Institute (EPRI) has addressed the issue of cement solidification in Topical Report 

NP-2900. Table F-1 of EPRI NP-2900 presents the type and amount of solidification agent to 

be used with various types of waste streams found in the nuclear power industry. The table 

specifically addresses the use of Portland cement as a solidification agent and addresses 

solidification of sodium sulfate waste streams which typically are generated by the neutralization 

of sodium hydroxide with sulfuric acid prior to solidification. Appendix D of EPRI NP-2900 

discusses leach rate tests of solidified waste. Appendix D provides significant data on leach 

rate tests of cement solidified sodium sulfate waste streams. Figure 1 of Appendix D indicates 

that if the weight percent of sodium sulfate in the solidified waste is eight weight percent or less, 

then leaching is in compliance with federal regulations, even for samples immersed in water. 

The applicant stated that the facility design is for waste streams with low concentrations of solid 

species that are below eight weight percent, as shown in the modified Table 9b.7-7 provided in 

the SHINE Response to RAI 11.2-4. Even after a volume reduction factor of 1.5, the contents of 

species other than water are not expected to exceed eight weight percent. Therefore, the 

applicant anticipates that the solidification process with cement will be successful and meet the 

acceptance criteria of potential waste disposal sites. SHINE will use the guidance included in 

EPRI NP-2900 in detailed design and in developing facility operating procedures for 

pre-treatment and cement solidification of liquid radwaste. SHINE’s operating procedures will 

implement the requirements of the facility solidification Process Control Program (PCP). SHINE 

will perform solidification demonstration test runs using non-licensed materials during facility 

commissioning.

The staff finds this response supports the validity of the assumption that the evaporator 

concentrates of the consolidated liquid waste stream can be solidified on Portland cement to 

meet the waste acceptance criteria of the potential disposal sites, and is therefore acceptable.

The staff notes that descriptions of the plans and procedures to provide reasonable assurance 

that radioactive wastes will be controlled at all times in a manner that protects the environment 

and the health and safety of the facility staff and the public will be presented in the FSAR. The 

staff finds this can reasonably be left for later consideration when it will be supplied in the FSAR.

On the basis of its review, the staff has determined that the level of detail provided on the 

radioactive waste controls satisfies the applicable acceptance criteria of NUREG 1537, Part 2, 

Section 11.2.2, allowing the staff to make the following relevant findings: (1) appropriate 

controls are described for radioactive waste management on the waste streams and products 

designed to prevent uncontrolled exposures or escape of radioactive waste; and (2) the 

applicant has described programmatic measures to evaluate the generation of radioactive 

wastes at the facility to define actions to maintain and control waste generation. 

Therefore, the staff finds that the design of radioactive waste controls meets the applicable 

regulatory requirements and guidance for issuance of a construction permit in accordance with 

10 CFR 50.35 and 50.40. Further evaluation of the radioactive waste controls plans and 

procedures will occur following the receipt of the FSAR submitted with the operating license 

application.

Release of Radioactive Waste

The staff evaluated the sufficiency of the radioactive effluents, as described in SHINE PSAR 

Section 11.2.3, “Release of Radioactive Waste,” using the guidance and acceptance criteria 
Radiation Protection Program and Waste Management

11-41

from Section 11.2.3, “Release of Radioactive Waste,” of NUREG-1537, Part 2 and the ISG 

Augmenting NUREG-1537, Part 2. 

Consistent with the review criteria of NUREG-1537, Part 2, Section 11.2.3, the staff evaluated 

the discussions on radioactive effluents for compliance with the regulations in Subpart K of 

10 CFR Part 20.

The staff notes the evaluation of the adequacy of controls on gaseous releases is presented in 

SER Section 11.4.4 and Section 11.4.7. According to PSAR Section 11.2.3, there will be no 

liquids containing radioactive effluents discharged to the sanitary sewer. Further, several liquid 

waste streams will be solidified on-site to meet shipping and waste acceptance criteria. 

The applicant has identified the requirements for adequate packaging of solid wastes for 

disposal and has committed to comply with 10 CFR 20, Subpart K and the waste acceptance 

criteria for the potential waste disposal sites. The description of procedures to be implemented 

to assure compliance with the requirements will be discussed in the FSAR. Review of the 

tables in PSAR Section 11.2 reveals acknowledgement of the requirements for waste 

characterization. Review of the system designs and capabilities for sampling necessary for 

waste characterization is presented in SER Section 9b4.7.

On the basis of its review, the staff has determined that the level of detail provided on the 

release of radioactive waste supports the preliminary design and satisfies the applicable 

acceptance criteria of NUREG 1537, Part 2, Section 11.2.3, allowing the staff to make the 

following relevant findings: (1) radionuclides have been sufficiently identified by quantities, 

other relevant characteristics, release points, and relevant environmental parameters; and 

(2) releases of radioactive effluents will likely be sufficiently be managed, controlled, and 

monitored so that limits in applicable regulations would not be exceeded.

Therefore, the staff finds that the design for release of radioactive waste is sufficient and meets 

the applicable regulatory requirements and guidance for issuance of a construction permit in 

accordance with 10 CFR 50.35 and 50.40. Further evaluation of the release of radioactive 

waste procedures will occur following the receipt of the FSAR submitted with the operating 

license application.

Respiratory Protection Program

The staff evaluated the sufficiency of the respiratory protection program, as described in SHINE 

PSAR Section 11.3, “Respiratory Protection Program,” using the guidance and acceptance 

criteria from Section 11.3, “Respiratory Protection Program,” of the ISG Augmenting 

NUREG-1537, Part 2. 

Consistent with the review criteria in NUREG-1537, Part 2, Section 11.3, the staff examined 

whether the respiratory protection program provides adequate protection of personnel from 

airborne concentrations exceeding the limits of Appendix B to 10 CFR Part 20. The staff 

reviewed the proposed radiation protection equipment for providing the appropriate degree of 

personal protection. The staff evaluated the description of respirator selection, training, fit 

testing, storage, maintenance, repair, and quality assurance.

The staff notes the respiratory protection program proposed by SHINE is consistent with the 

hierarchy of protection intended by Subpart H of 10 CFR 20, (i.e., HVAC system considerations 

first, followed by the use of respiratory protective equipment) only when HVAC controls are not 
Radiation Protection Program and Waste Management

11-42

practical or are ineffective. The applicant stated that only NIOSH-certified respiratory equipment 

will be used and that written procedures will be prepared for all key program elements. The 

program will include a review by a physician to certify that an individual is medically fit to wear 

respiratory protective equipment and that quantitative fit testing will be performed. Regarding 

respirator quantitative fit testing, PSAR Section 11.3 states that “...a minimum fit factor of at 

least 10 times the ... assigned protection factor (APF) for negative pressure devices, and....at 

least 500 times the APF for any positive pressure, continuous flow, and pressure-demand 

devices...” Because the APF is typically 1000 for the latter devices, to require demonstration of 

a fit APF of 500,000 (i.e., 500 x 1000) may be beyond the capabilities of most quantitative fit 

testing methods. Prior to issuing the operating license, this matter needs to be reviewed in light 

of the guidance contained in Regulatory Guide 8.15, “Acceptable Programs for Respiratory 

Protection” (Reference 98), and related documents and appropriate clarification included in the 

FSAR.

PSAR Section 9a2.1.1 indicates that air which passes from radiation controlled area ventilation 

Zone 2 (RVZ2) to radiation controlled ventilation Zone 1 (RVZ1) is first passed through HEPA 

filtration. This implies that the zones are isolated from each other and that air is filtered between 

each zone. Therefore, in RAI 11.3-1 (Reference 17), the staff asked the applicant to provide 

additional information to clarify whether each zone can be isolated from the other zones 

automatically using the automatic isolation dampers and whether the air is filtered between each 

zone.

In response to RAI 11.3-1 (Reference 26), the applicant stated that RVZ1 areas draw supply air 

from adjacent RVZ2 spaces. RVZ1 area air inlets are equipped with automatic isolation 

dampers (fail closed), manual isolation dampers, and non-credited HEPA filters. The air inlet 

HEPA filter ensures that if an RVZ1 area were to see a flow reversal, the air stream would be 

filtered. Should high radiation levels be detected within an RVZ1 area, ESFAS (IF) or RICS 

(RPF) would generate a confinement isolation signal, closing the corresponding bubble-tight 

isolation dampers on the air inlet and exhaust outlet for each affected RVZ1 area. SHINE states 

that this automatic isolation provides isolation between the affected RVZ1 area and the adjacent 

RVZ2 space. Confinement barrier penetrations are sealed, as necessary, to reduce leakage. 

However, SHINE expects some leakage between zones even after the isolation described 

above, and potential leakage is accounted for in safety analysis calculations, as described in 

PSAR Chapter 13. RVZ1 exhaust can also be isolated downstream of the filter trains on high 

radiation levels in RVZ1. SHINE states that this point of RVZ1 isolation does not isolate RVZ1 

from the other zones; however, it provides an additional means to reduce releases to the 

environment. Also, should high radiation levels be detected within RVZ2, RICS would generate

a signal for confinement isolation at the RCA boundary, which would close bubble-tight isolation 

dampers in the supply duct at the RCA boundary and in the RVZ2 exhaust duct downstream of 

the final filters. SHINE states that this automatic isolation does not isolate RVZ2 from other 

zones directly; however, it would reduce the potential releases to the environment. SHINE 

states that there are no automatic isolations necessary or provided for RVZ3 or FVZ4.

The staff finds this response clarifies whether each zone can be isolated from the other zones 

automatically using the automatic isolation dampers and whether the air is filtered between each 

zone to meet the acceptance criteria of the ISG Augmenting NUREG-1537, Section 11.3.

SHINE PSAR Section 9a2.1.1 (page 9a2-2) indicates that the ventilation air in the exhaust 

header is tested before being exhausted to the stack. However, the NRC staff determined that

additional information was needed to determine the adequacy of the ventilation system at the 

SHINE facility. Therefore, in RAI 11.3-2 (Reference 17), the staff asked the applicant to provide 
Radiation Protection Program and Waste Management

11-43

additional information to demonstrate that the tests will verify some pre-defined differential 

pressure gradient across the filters and measure the level of contamination following the filters. 

In response to RAI 11.3-2 (Reference 26), the applicant referenced PSAR Section 9a2.1.1, 

which states that the exhaust from the cells collects in an RVZ1 system duct header and then 

draws through final, testable, HEPA filters and carbon adsorbers prior to discharge into the 

exhaust stack. SHINE PSAR Section 9a2.1.1 also that states that the exhaust air collects in an 

RVZ2 exhaust header and then draws through final, testable, HEPA filters and carbon 

adsorbers prior to discharge into the exhaust stack.

SHINE clarified that PSAR Section 9a2.1.1 states that HEPA filters and carbon adsorbers are 

testable, not that ventilation air in the exhaust header is tested before being exhausted to the 

stack. SHINE stated that it will test the pressure differential across HEPA filters and 

decontamination efficiencies of carbon adsorbers to ensure adequate operation and minimize 

the potential for contamination downstream of the exhaust filter housings. SHINE also indicated 

it will ensure differential pressure instruments are installed to allow for filter monitoring. SHINE’s 

operators will periodically monitor differential pressure and compare the measurement to a 

pre-defined allowed pressure gradient. If monitoring or testing indicate filter or charcoal 

adsorber replacement is necessary, SHINE will initiate an IMR to ensure corrective actions are 

taken (e.g., filter replacement).

The staff finds this response describes the tests SHINE will perform to verify the differential 

pressure gradient across the filters and measure the level of contamination following the filters, 

and is therefore acceptable.

SHINE PSAR Section 9a2.1.1 (page 9a2-3) states that fume hood exhaust ducts are controlled 

automatically to compensate for changes in pressure drops for loading of filters. However, the 

NRC staff determined that additional information was needed to determine the adequacy of the 

ventilation system at the SHINE facility. Therefore, in RAI 11.3-3 (Reference 17), the staff 

asked the applicant to justify that an acceptable differential pressure will be maintained across 

facility air filters.

In response to RAI 11.3-3 (Reference 26), the applicant stated that it will monitor fume hood 

exhaust for adequate airflow consistent with the ventilation survey guidance provided in 

Regulatory Guide 8.24 (Reference 83). If monitoring indicates deficient airflow, SHINE will 

initiate an IMR for corrective action (e.g., filter replacement). SHINE will include the 

requirements for monitoring in its RP Program. The staff finds this response commits to an 

acceptable approach to maintaining differential pressure across facility air filters, and is 

therefore acceptable.

SHINE PSAR Sections 9a2.1.1 and 11.3, “Respiratory Protection Program,” do not provide the 

minimum flow velocity at openings, maximum differential pressure across filters, or types of 

filters to be used. Therefore, in RAI 11.3-4 (Reference 17), the staff asked the applicant to 

describe the criteria for the ventilation and containment systems, including minimum flow 

velocity at openings in these systems, maximum differential pressure across filters, and types of 

filters to be used.

In response to RAI 11.3-4 (Reference 26), the applicant stated that the facility does not have a 

containment feature, but uses confinement to minimize the release and spread of radioactive 

contamination. The design basis for confinement is described in PSAR Section 6a2.2.1. The 

applicant added that it will follow the ventilation survey guidance in Regulatory Guide 8.24 for 
Radiation Protection Program and Waste Management

11-44

fume hood and glovebox operations and maintenance involving uranium-235 processing. This 

guidance includes monthly surveys to determine that airflow velocities in hoods preclude the 

escape of airborne uranium and to minimize potential intake by workers, as well as surveys of 

negative pressure maintained in gloveboxes. SHINE will provide the specific criteria for the 

ventilation systems, including minimum flow velocity at openings in these systems, maximum 

differential pressure across filters, and types of filters to be used will be determined in the 

FSAR. SHINE has initiated an IMR to track inclusion of this information in the FSAR. The staff 

finds this response adequately describe the criteria for the ventilation and containment systems

for construction, and is therefore acceptable.

On the basis of its review, the staff has determined that SHINE has committed to an acceptable 

radiation protection program that includes a program to control airborne concentration of 

radioactive material with engineering controls and respiratory protection. The level of detail 

provided on the respiratory protection program satisfies the applicable acceptance criteria of the 

ISG Augmenting NUREG-1537, Part 2, Section 11.2.2, allowing the staff to make the following 

relevant finding: the program is generally consistent (given the level of detail available at the 

facility design stage) with Regulatory Guide 8.15 and Subpart H and Appendix A of 

10 CFR Part 20.

Therefore, the staff finds that the design of respiratory protection program meets the applicable 

regulatory requirements and guidance for issuance of a construction permit in accordance with 

10 CFR 50.35 and 50.40. Further evaluation of the respiratory protection program and 

quantitative fit testing will occur following the receipt of the FSAR submitted with the operating 

license application.

Probable Subjects of Technical Specifications

In accordance with 10 CFR 50.34(a)(5), the staff evaluated the sufficiency of the applicant’s 

identification and justification for the selection of those variables, conditions, or other items 

which are determined to be probable subjects of technical specifications for the radiation 

protection program and waste management provisions, with special attention given to those 

items which may significantly influence the final design.

Based on the information provided in Table 14a2-1 of the SHINE PSAR, the staff finds that 

identification and justification of the proposed conditions related to radiation protection or waste 

management (e.g., LCOs for the Radiation Monitoring Systems and Effluents, conditions related 

to design features of the noble gas decay tank storage cell) are sufficient and meet the 

applicable regulatory requirements for the issuance of construction permit in accordance with 

10 CFR 50.35. A detailed evaluation of technical specifications, including LCOs and 

surveillance requirements, will be performed during the review of SHINE’s operating license 

application.

Summary and Conclusions

The staff evaluated the descriptions and discussions of the SHINE facility radiation protection 

program and waste management provisions, as described in PSAR Chapter 11 and 

supplemented by the applicant’s responses to RAIs, and finds that the preliminary design 

criteria of the radiation protection program and waste management provisions, including the 

principal design criteria, design bases, and information relative to materials of construction, 

general arrangement, and approximate dimensions: (1) provides reasonable assurance that the 

final design will conform to the design basis, and (2) meets all applicable regulatory 
Radiation Protection Program and Waste Management

11-45

requirements and acceptance criteria discussed in NUREG-1537 and the ISG augmenting 

NUREG-1537. Based on these findings, the staff has made the following conclusions regarding 

issuance of a construction permit in accordance with 10 CFR 50.35 and 10 CFR 50.40:

(1) SHINE has described the proposed facility design criteria for radiation protection and 

waste management, including, but not limited to, the principal architectural and 

engineering criteria for the design, and has identified the major features or 

components incorporated therein for the protection of the health and safety of the 

public.

(2) Further technical or design information required to complete the safety analysis of the 

radiation protection program and waste management provisions may reasonably be 

left for later consideration the FSAR.

(3) There is reasonable assurance that, taking into consideration the site criteria contained 

in 10 CFR Part 100, the proposed facility can be constructed and operated at the 

proposed location without undue risk to the health and safety of the public.

(4) There is reasonable assurance: (i) that the construction of the SHINE facility will not 

endanger the health and safety of the public, and (ii) that construction activities can be 

conducted in compliance with the Commission’s regulations.

(5) The issuance of a permit for the construction of the facility would not be inimical to the 

common defense and security or to the health and safety of the public.

12-1

CONDUCT OF OPERATIONS

The conduct of operations involves the administrative aspects of facility operation, the 

organizational structure, the functional responsibilities, levels of authority, and interface for 

establishing, executing, and verifying the organizational structure, staffing, and selection and 

training of personnel.

This chapter of the SHINE construction permit safety evaluation report (SER) describes the 

review and evaluation of the U.S. Nuclear Regulatory commission (NRC) staff (the staff) of the 

preliminary design of the SHINE conduct of operations as presented in Chapter 12, “Conduct of 

Operations,” of the SHINE PSAR, as supplemented by the applicant’s response to requests for 

additional information (RAIs).

Areas of Review

SHINE PSAR Chapter 12 describes the conduct of operations for the IUs and RPF; therefore, 

the areas of review related to conduct of operations presented in this section are applicable to 

both the IUs and RPF.

The staff reviewed SHINE PSAR Chapter 12 against applicable regulatory requirements using

regulatory guidance and standards to assess the sufficiency of the preliminary design of the 

SHINE conduct of operations program. The following sections of the SER describe the areas 

reviewed as specified in NUREG-1537, Part 2, and the ISG Augmenting NUREG-1537, Part 2. 

Section 12.4.1, “Organization,” provides an evaluation of the SHINE organizational structure. 

Within this review area, the staff assessed the organizational structure, responsibilities of 

individuals and groups, staffing for reactor operations, selection and training of personnel, 

organizational aspects of radiation protection, and radioisotope production facility safety 

program.

Section 12.4.2, “Review and Audit Activities,” provides an evaluation of the SHINE composition 

and qualification of the SHINE committee members, charter and rules of the committees, 

conduct of the review functions, and conduct of the audit functions.

Section 12.4.3, “Procedures”, provides an evaluation of the SHINE procedures, and procedural 

controls, to include the minimum topics for which procedures are required, the process for the 

review and approval of procedures, and the process for making substantive, minor, and 

temporary changes to procedures.

Section 12.4.4, “Required Actions,” usually provides an evaluation on actions to be taken after a 

reportable event or a violation of the facility safety limits; however, as this subject is specific to 

operations of the facility, the applicant has deferred submittal of this section until the FSAR.

Section 12.4.5, “Reports,” usually provides an evaluation on the submission of timely 

information to the NRC in the form of annual reports and special reports (e.g., reportable events, 

violations of safety limits, changes in key personnel, changes in transient or accident analysis); 

however, as this subject is specific to operations of the facility, the applicant has deferred 

submittal of this section until the FSAR.
Conduct of Operations

12-2

Section 12.4.6, “Records,” usually provides an evaluation on facility records, including review 

and retention guidelines; however, as this subject is specific to operations of the facility, the 

applicant has deferred submittal of this section until the FSAR.

Section 12.4.7, “Emergency Planning,” provides an evaluation of the SHINE Preliminary 

Emergency Plan. The Preliminary Emergency Plan discusses those necessary provisions for 

coping with radiological emergencies and minimizing the consequences of accidents at facilities. 

The staff evaluation included the review of plans, design features, facilities, functions, and 

equipment necessary to address the provisions for coping with radiological emergencies at the 

facility.

Section 12.4.8, “Security Planning,” usually provides an evaluation of the SHINE Physical 

Security Plan; however, the applicant since security planning is not required until the submission 

of a FSAR per 10 CFR 50.34(b), SHINE has deferred submittal of this section.

Section 12.4.9, “Quality Assurance,” provides an evaluation of the SHINE quality assurance 

program to be applied to the design, fabrication, construction, and testing of the structures, 

systems, and components of the facility.

Section 12.4.10, “Operator Training and Requalification,” usually provides an evaluation of the 

operator training and requalification plan; however, as this subject is specific to operations of the 

facility, the applicant has deferred submittal of this section until the FSAR.

Section 12.4.11, “Startup Plan,” usually provides an evaluation of the proposed tests to 

determine operability and the timing of a report that summarizes the results of the startup tests; 

however, as this subject is specific to operations of the facility, the applicant has deferred 

submittal of this section until the FSAR.

Section 12.4.12, “Environmental Reports,” has been superseded by Chapter 19, “Environmental 

Review.” As such, the staff’s evaluation of SHINE’s environmental report was not within the 

scope of this chapter of the SER. The staff’s evaluation of SHINE’s environmental report, 

submitted as Chapter 19, “Environmental Review,” of the SHINE PSAR, is documented in 

NUREG-2183, “Environmental Impact Statement for the Construction Permit for the SHINE 

Medical Radioisotope Production Facility.”

Section 12.4.13, “Material Control and Accounting Plan,” usually provides an evaluation of the 

proposed material control and accounting (MC&A) plan; however, as this subject is specific to 

operations of the facility, the applicant has deferred submittal of this section until the FSAR.

Summary of Application 

SHINE PSAR Section 12.1, “Organization,” describes the organizational structure, functional 

responsibilities, levels of authority, and interfaces for establishing, executing, and verifying the 

organizational structure. The organizational structure includes internal and external functions 

for SHINE, including interface responsibilities for multiple organizations. 

SHINE PSAR Section 12.2, “Review and Audit Activities,” discusses review and audit activities. 

The Plant Manager is responsible to establish review and audit committees and ensures that 

the appropriate technical expertise is available for review and audit activities. These activities 

are summarized and reported to Executive Management. Independent audits of the SHINE 

facility are conducted periodically.
Conduct of Operations

12-3

SHINE PSAR Section 12.3, “Procedures,” provides a description of the operating procedures. 

Operating procedures provide appropriate direction to ensure that the facility is operated 

normally within its design basis, and in compliance with technical specifications. Operating 

procedures are written, reviewed, and approved by appropriate management, as well as 

controlled and monitored to ensure that the content is technically correct and the wording and 

format are clear and concise. The SHINE policy on use of procedures is documented. The 

extent of detail in a procedure is dependent on the complexity of the task; the experience, 

education, and training of the users; and the potential significance of the consequences of error. 

The process for making changes and revisions to procedures is documented. A controlled copy 

of all operations procedures is maintained in the control room or equivalent area. Activities and 

tasks are performed consistent with approved implementing procedures.

SHINE PSAR Sections 12.4, “Required Actions,” 12.5, “Reports,” 12.6, “Records,” Section 12.8, 

“Security Planning,” 12.10, “Operator Training and Requalification,” 12.11, “Startup Plan,” and 

12.13, “Material Control and Accountability Program,” are specific to operations of the facility, 

and as such, the applicant has deferred submittal of this information until the FSAR.

SHINE PSAR Section 12.7, “Emergency Planning,” consists of the SHINE Preliminary 

Emergency Plan, Revision 0, which describes the necessary provisions that are established for 

coping with radiological emergencies and minimizing the consequences of accidents at the 

facility. The SHINE Emergency Response Organization (ERO) is defined, including the roles, 

responsibilities and interfaces with other organizations. The emergency classification system 

describes the classifications based on a range of events described in SHINE PSAR Chapter 13. 

The emergency action levels provide specific parameters that are intended to activate 

appropriate portions of the SHINE ERO and initiate protective actions for an event. The plan 

also discusses whether any radiological emergencies would necessitate establishing an 

Emergency Planning Zone (EPZ). A general discussion is provided on the organizational 

response to emergencies. An overview is provided on emergency facilities and equipment 

necessary to respond to emergencies. Additionally, actions needed to restore the facility to a 

safe condition following emergency conditions are discussed.

SHINE PSAR Section 12.9, “Quality Assurance,” provides a description of the quality assurance 

(QA) program to be applied to the design, fabrication, construction, and testing of the structures, 

systems, and components of the facility. The applicant provided the SHINE Quality Assurance 

Program Description (QAPD) in Appendix C of Chapter 12 of the PSAR.

SHINE PSAR Section 12.4.12, “Environmental Reports,” has been superseded by Chapter 19, 

“Environmental Review,” and is therefore vacated. As such, SHINE submitted its environmental 

report as Chapter 19 of its PSAR. The staff’s evaluation of this is documented in NUREG-2183, 

“Environmental Impact Statement for the Construction Permit for the SHINE Medical 

Radioisotope Production Facility.”

Regulatory Basis and Acceptance Criteria

As previously stated, SHINE PSAR Chapter 12 describes the conduct of operations for the IF 

and RPF; therefore, the regulatory basis and acceptance criteria provided below apply to both 

the IF and RPF.

The staff reviewed SHINE PSAR Chapter 12 against applicable regulatory requirements, using 

regulatory guidance and standards, to assess the sufficiency of the preliminary design and 

performance of the SHINE organization for the issuance of a construction permit. In 
Conduct of Operations

12-4

accordance with paragraph (a) of Title 10 of the Code of Federal Regulations (10 CFR) 50.35, 

“Issuance of Construction Permits,” a construction permit authorizing SHINE to proceed with 

construction may be issued once the following findings have been made:

(1) SHINE has described the proposed design of the facility, including, but not limited to, 

the principal architectural and engineering criteria for the design, and has identified the 

major features or components incorporated therein for the protection of the health and 

safety of the public. 

(2) Such further technical or design information as may be required to complete the safety 

analysis, and which can reasonably be left for later consideration, will be supplied in 

the final safety analysis report (FSAR). 

(3) Safety features or components, if any, which require research and development have 

been described by SHINE and a research and development program will be conducted 

that is reasonably designed to resolve any safety questions associated with such 

features or components. 

(4) On the basis of the foregoing, there is reasonable assurance that: (i) such safety 

questions will be satisfactorily resolved at or before the latest date stated in the 

application for completion of construction of the proposed facility, and (ii) taking into 

consideration the site criteria contained in part 100 of this chapter, the proposed facility 

can be constructed and operated at the proposed location without undue risk to the 

health and safety of the public.

With respect to the last of these findings, the staff notes that the requirements of 

10 CFR Part 100 are specific to nuclear power reactors, and therefore not applicable to the 

SHINE facility. However, the staff evaluated SHINE’s site specific conditions using site criteria 

similar to 10 CFR Part 100, by using the guidance in NUREG-1537. The staff’s review 

evaluated the geography and demography of the site; nearby industrial, transportation, and 

military facilities; site meteorology; site hydrology; and site geology, seismology, and 

geotechnical engineering to ensure that issuance of the construction permit will not be inimical 

to public health and safety.

The staff’s evaluation of the preliminary design of the SHINE organization does not constitute 

approval of the safety of any design feature or specification. Such approval will be made 

following the evaluation of the final design of the SHINE organization, as described in the FSAR 

as part of the SHINE operating license application.

Applicable Regulatory Requirements

The applicable regulatory requirements for the evaluation of the SHINE organization are as

follows:

• 10 CFR 50.34, “Contents of applications; technical information,” paragraph (a), 

“Preliminary safety analysis report.”

• 10 CFR 50.40, “Common standards.”

• 10 CFR Part 50, Appendix E, Part II, “Preliminary Safety Analysis Report.”
Conduct of Operations

12-5

Regulatory Guidance and Acceptance Criteria

In applying guidance and acceptance criteria, the staff used its judgment as to which 

acceptance criteria were relevant to SHINE’s proposed facility, as much of this guidance was 

originally developed for nuclear reactors. Given the similarities in SHINE’s proposed facility and 

non-power research reactors, the staff used established guidance documents and the 

Commission’s regulations to determine the acceptance criteria for demonstrating compliance 

with 10 CFR regulatory requirements. For example, the staff used: 

• NUREG-1537, Part 1, “Guidelines for Preparing and Reviewing Applications for the 

Licensing of Non-Power Reactors, Format and Content,” issued February 1996 

(Reference 4).

• 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 (Reference 5).

• “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 (Reference 6).

• “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 (Reference 7).

As stated in the ISG Augmenting NUREG-1537, the staff determined that certain guidance 

originally developed for heterogeneous non-power research and test reactors is applicable to 

aqueous homogenous facilities and production facilities. SHINE used this guidance to inform 

the design of its facility and prepare its PSAR. The staff’s use of reactor-based guidance in its 

evaluation of the SHINE PSAR is consistent with the ISG Augmenting NUREG-1537.

As appropriate, additional guidance (e.g., NRC regulatory guides, Institute of Electrical and 

Electronics Engineers (IEEE) standards, American National Standards Institute/American 

Nuclear Society (ANSI/ANS) standards) has been used in the staff’s review of SHINE’s PSAR. 

The use of additional guidance is based on the technical judgment of the reviewer, as well as 

references in NUREG-1537, Parts 1 and 2; the ISG Augmenting NUREG-1537, Parts 1 and 2; 

and the SHINE PSAR. Additional guidance documents used to evaluate SHINE’s PSAR are 

provided as references in Appendix B of this SER.

Review Procedures and Technical Evaluation

As previously stated, SHINE PSAR Chapter 12 describes the conduct of operations for the IUs 

and RPF; therefore, the technical evaluation of the SHINE conduct of operations, described in 

SHINE PSAR Chapter 12, applies to both the IUs and RPF.

The staff evaluated the technical information presented in SHINE PSAR Chapter 12, as 

supplemented by the applicant’s response to RAIs, to assess the sufficiency of the preliminary 

design and performance of the SHINE conduct of operations for the issuance of a construction 
Conduct of Operations

12-6

permit, in accordance with 10 CFR 50.35(a). The sufficiency of the preliminary design and 

performance of the SHINE conduct of operations is determined by ensuring the design and 

performance meet applicable regulatory requirements, guidance, and acceptance criteria, as 

discussed in SER Section 12.3, “Regulatory Basis and Acceptance Criteria.” The results of this 

technical evaluation are summarized in SER Section 12.5, “Summary and Conclusions.”

Organization

The staff evaluated the sufficiency of the preliminary design of the SHINE organization, as 

described in SHINE PSAR Section 12.1, in part by reviewing the organizational structure, the 

responsibilities of individuals and groups, the staffing for operations, the selection and training of 

personnel, the organizational aspects of radiation protection, and the production facility safety 

program, using the guidance and acceptance criteria from Section 12.1, “Organization,” of ISG 

Augmenting NUREG-1537, Parts 1 and 2, and of NUREG-1537, Parts 1 and 2.

Consistent with the review criteria in Chapter 14, “Technical Specifications,” of NUREG-1537, 

Part 2, Section 12.1, and ANSI/ANS 15.1-2007, “The Development of Technical Specifications 

for Research Reactors,” Reaffirmed April 24, 2013, the staff evaluated the description of the 

SHINE review and audit activities to ensure that the PSAR provides a basis for the technical 

specification requirements for the organization activities.

The review procedures of NUREG-1537, Part 1, Section 12.1.1, “Structure,” state that the 

description of the organizational structure should include the radiation safety function and 

indicate how the staff implementing that function interacts with the staff responsible for reactor 

operations and the top administrative officials. The multilevel chart should show the relationship 

of the review and audit function to the organizational structure. The persons implementing the 

review and audit function should communicate with the management of the reactor facility, but 

should report to an organizational level above this management to ensure independence of the 

review and audit function.”

The SHINE PSAR provides the functional organization in Figure 12.1-1, and PSAR, Section 

12.1, “Structure,” states, in part, that “[t]he staff implementing the radiation safety function 

supports on-shift plant operations and interacts with Executive Management through the chain 

of command.” However, the organization chart does not include the review and audit function or 

the radiation safety function.

Therefore, in RAI 12.1-1 (Reference 14), the staff requested that the applicant:

a) Include the review and audit committee and the radiation safety function in the 

organization chart. 

b) Describe the responsibilities of the review and audit committee and the radiation safety 

function under PSAR Section 12.1.2, “Responsibility.” 

Additionally, the applicant was requested to ensure that the responsibility for the safe operation 

of the facility and for the protection of the health and safety of the staff and the public is clearly 

shown in Section 12.1.2 of the PSAR.

In its revised response to RAI 12.1-1 (Reference 99), the applicant stated that the SHINE 

Review and Audit Committee will report to the Chief Operating Officer and the SHINE radiation 

safety function (Radiation Protection Supervisor) will report to the Environmental Safety and 
Conduct of Operations

12-7

Health Manager. The applicant also provided an updated Operational Organization Chart 

showing the reporting and communication lines of the Review and Audit Committee and the 

Radiation Protection Supervisor. A revised figure 12.1-1 was provided via Revision 1 of the 

SHINE response to RAI 12.1-1 (Reference 99). An update to the PSAR on May 21, 2015 

included a description of the SHINE management levels (Reference 32).

The staff reviewed Figure 12.1-1 and the information to be included in Section 12.1.2 of the 

SHINE FSAR to determine whether it is acceptable by evaluating the new figure and reviewing 

the information against the requirements of NUREG-1537. 

The staff finds the new Figure 12.1-1 and the information to be acceptable for the issuance of a 

construction permit because the new figure and information describe and show the review and 

audit committee and the radiation safety function and describe their responsibilities. SHINE has 

revised its PSAR in include this information.

NUREG-1537, Part 2, Section 12.1, “Organization,” Acceptance Criteria, states, in part, that 

“[t]he applicant should discuss the training of personnel, should reference the operator training 

program and the operator requalification program, and should include a review of compliance

with the requirements of 10 CFR Part 55” [“Operators’ Licenses”].

SHINE PSAR, Section 12.1.4, “Selection and Training Of Personnel,” states, in part, that 

“SHINE establishes and maintains formal and informal indoctrination and training programs for 

personnel performing, verifying, or managing facility operation activities to ensure that suitable 

proficiency is achieved and maintained. The Training Manager (TM) is responsible to the PM 

[Plant Manager] for development and implementation of training that ensures satisfactory 

operational behavior and performance in the areas of nuclear, industrial, and radiological 

safety.” However, SHINE PSAR, Section 12.1.4, does not include a reference to the operator 

requalification program or a review of compliance with the requirements of 10 CFR Part 55, as 

applicable.

Additional information was required for the staff to make a determination on the acceptability of 

the training of personnel. In RAI 12.1-2 (Reference 14), the staff requested that the applicant:

a) Include a reference to the operator training program and the operator requalification 

program. 

b) Provide a review of SHINE’s compliance with the requirement of 10 CFR Part 55, as 

applicable

c) Indicate if minimum requirements exist for the facility staff.

In response to RAI 12.1-2 (Reference 20), the applicant stated that the SHINE will do the 

following: 

a) State that the licensed operator training program, including the requalification training 

program, will be developed and implemented in accordance with 10 CFR Part 55 as it 

pertains to non-power facilities.

b) State that SHINE will comply with the requirements of 10 CFR Part 55 as it pertains to 

non-power facilities.

c) Provide the required minimum qualifications for facility staff. 

On the basis of its review, the staff has determined that the level of detail provided on the 

SHINE organization activities is adequate and supports the applicable acceptance criteria of 
Conduct of Operations

12-8

NUREG-1537, Part 2, Section 12.1, allowing the staff to make a finding that the applicant’s 

commitments to develop and conduct organization activities provide reasonable assurance that 

the SHINE organization activities will comply with applicable requirements and be consistent 

with guidance.

Therefore, the staff finds the information to be included in SHINE FSAR Section 12.1, 

supplemented by the applicant’s response to two RAIs, is sufficient and meets the applicable 

regulatory requirements and guidance for the issuance of a construction permit in accordance 

with 10 CFR 50.35. Further information required to complete the review may reasonably be left 

for later consideration. Following receipt of the SHINE FSAR, the staff will confirm that the 

above issues have been resolved.

Review and Audit Activities

The staff evaluated the sufficiency of the preliminary design of the SHINE review and audit 

activities, as described in SHINE PSAR Section 12.2, in part, by reviewing the composition and 

qualification of the committee members, charter and rules of the committee, conduct of the 

review function, and conduct of the audit function, using the guidance and acceptance criteria 

from Section 12.2, “Review and Audit Activities,” of NUREG-1537, Parts 1 and 2.

Consistent with the review criteria in Chapter 14 of NUREG-1537, Part 2, Section 12.2, and 

ANSI/ANS 15.1-2007, the staff evaluated the description of the SHINE review and audit 

activities to ensure that the PSAR provides a basis for the technical specification requirements 

for the review and audit function.

While the above referenced PSAR sections described adequate review and audit activities, 

some further clarifications were needed. 

NUREG-1537, Part 1, Section 12.2, “Review and Audit Activities,” notes that the applicant 

should explicitly state who holds the approval authority and should specify how the review and 

audit committees communicate and interact with facility management and corporate 

management.

SHINE PSAR, Section 12.2, “Review and Audit Activities,” discusses the establishment of the 

review and audit committees and states they report to Executive Management. However, 

approval authority is not addressed. Therefore, in RAI 12.2-1 (Reference 14), the staff 

requested that the applicant provide the following additional information:

a) State who holds approval authority.

b) Provide additional detail on how the review and audit committees interact with 

management.

In an updated response to RAI 12.1-1 (Reference 99), the applicant provided the following 

information: 

a) The Chief Operating Officer holds approval authority for review and audit activities. 

b) The review and audit committees’ interaction with facility management was detailed.

SHINE updated its PSAR to incorporate the above details of who has approval authority and 

how the review and audit committees interact with facility management.
Conduct of Operations

12-9

NUREG-1537, Part 2, Section 12.2, “Review and Audit Activities,” Acceptance Criteria, states, 

in part, that “[t]he applicant should give the details of the review function...The reviews should 

include 10 CFR 50.59 [“Changes, tests, and experiments”] safety reviews.” SHINE PSAR, 

Section 12.2.3, “Review Function,” did not include this in the list of items required to be 

reviewed. In RAI 12.2-2 (Reference 14), the staff requested that the applicant add 

10 CFR 50.59 safety reviews to the list of items to be reviewed or justify their exclusion.

In response to RAI 12.2-2 (Reference 20), the applicant stated that, the list of items in PSAR 

Section 12.2.3 requiring review by the SHINE review and audit committee will be updated in the 

SHINE FSAR to include 10 CFR 50.59 safety reviews. SHINE updated Section 12.2.3 of its 

PSAR to add “10 CFR 50.59 safety reviews” to the list of items requiring review by the SHINE 

review and audit committee.

NUREG-1537, Part 2, Section 12.2, “Review and Audit Activities,” Acceptance Criteria, states, 

in part, that “[t]he applicant should give the details of the audit function. The minimum list of 

items to be audited should be that given in ANSI/ANS 15.1-1990 [‘The Development of 

Technical Specifications for Research Reactors’],.... The audit of facility operations should 

include items such as organization and responsibilities, training, reactor operations, procedures, 

logs and records, experiments, health physics, technical specification compliance, and 

surveillances.”

In addition, NUREG-1537, Part 1, Section 12.2.4, “Audit Function,” states, in part, that “[t]he 

applicant should list and discuss the items that must be audited by the committee. In addition to 

audits by the facility committee, the licensee may consider entering into an auditing agreement 

with other non-power reactor facilities to bring in staff members from other non-power reactors 

to perform an audit.”

SHINE PSAR, Section 12.2.4, “Audit Function,” includes a list of examples of activities to be 

audited, but did not include details addressing the items above. Therefore, in RAI 12.2-3 

(Reference 14), the staff asked the applicant to provide additional information expanding PSAR 

Section 12.2.4 to include the details addressing the items above, or justify their exclusion.

In response to RAI 12.2-3 (Reference 20), the applicant stated it will update Section 12.2.4 to 

expand on the description of SHINE activities to be audited, the audit frequencies, and 

information on the reporting of audit findings. SHINE stated they will work to establish 

relationships with other entities to participate in audits of the facility. SHINE has since updated 

Section 12.2.4 of the PSAR with this information.

On the basis of its review, the staff has determined that the level of detail provided on the 

SHINE review and audit activities is adequate and supports the applicable acceptance criteria of 

NUREG-1537, Part 2, Section 12.2, allowing the staff to make a finding that the applicant’s 

commitments to develop and conduct review and audit activities provide reasonable assurance 

that the SHINE review and audit activities will comply with applicable requirements.

Therefore, the staff finds the information to be included in SHINE FSAR Section 12.2, as 

supplemented by the applicant’s response to three RAIs, is sufficient and meets the applicable 

regulatory requirements and guidance for the issuance of a construction permit in accordance 

with 10 CFR 50.35. Further information required to complete the review may reasonably be left 

for later consideration. Following receipt of the SHINE FSAR, the staff will confirm that the 

above issues have been resolved.
Conduct of Operations

12-10

Procedures

The staff evaluated the sufficiency of the preliminary design of the SHINE procedures, as 

described in SHINE PSAR Section 12.3, using the guidance and acceptance criteria from 

Section 12.3, “Procedures,” in NUREG-1537, Part 1 and 2.

Consistent with the review criteria of Chapter 14 of NUREG-1537, Part 2, Section 12.3, and 

ANSI/ANS 15.1-2007, the staff evaluated the description of the SHINE procedure activities to 

ensure that the PSAR provides a basis for the technical specification requirements for 

procedures.

While the above referenced PSAR sections described adequate procedure activities, some 

further clarification was needed. 

NUREG-1537, Part 1, Section 12.3, “Procedures,” states, in part, that “[t]he applicant should 

discuss the basic topics that the procedures do or will cover...The applicant should discuss the 

methodology used for developing procedures, including the approval process. The applicant 

should also discuss the process required to make changes to procedures including substantive 

and minor permanent changes, as defined in ANSI/ANS 15.1[-2007 (Reference 55)], and 

temporary deviations to deal with special or unusual circumstances during operation. The 

applicant should note that 10 CFR 50.59 may apply to changes to procedures.”

NUREG-1537, Part 2, Section 12.3, “Procedures,” Acceptance Criteria, states, in part, that “[t]he 

applicant should discuss the method for the review and approval of procedures. The method 

should involve staff from reactor operations, radiation protection, and reactor administration and 

the review committee, as appropriate to the procedure under review and approval.” Section 

12.3 also states, in part, that “[t]he applicant should propose a method for making changes to 

procedures. This method should cover minor changes with little or no safety significance, 

substantive changes that are safety significant, and temporary deviations caused by operational 

needs.” SHINE PSAR, Section 12.3, “Procedures,” discusses operating procedures and the 

procedure program. It generally discusses the use of procedures and that the process for 

making changes and revisions is documented. However, additional detail was needed for the 

staff to assess the adequacy of the SHINE preliminary operating procedures and procedure 

program.

Therefore, in RAI 12.3-1 (Reference 14), the staff asked that the applicant:

a) Discuss the basic topics the procedures address or will cover.

b) Discuss the method for the review and approval of procedures.

c) Discuss the process required to make changes to procedures noting that 10 CFR 50.59 

may apply to changes to procedures.

In response to RAI 12.3-1 (Reference 20), the applicant provided the following:

a) A list of the basic topics that SHINE procedures will cover, which will be developed 

consistent with Section 2.5 of the SHINE QAPD.

b) A description of the method for the initial review and approval of procedures activities 

listed in Part (a) of the SHINE response to RAI 12.3-1 was given. The applicant stated 

that this same method also applies when there are substantive changes to the 

procedures.
Conduct of Operations

12-11

c) A discussion concerning the process required to make changes to procedures. The 

applicant stated that revisions to procedures related to activities listed in Part (a) of the 

SHINE Response to RAI 12.3-1 are initiated and tracked via the SHINE Information 

Management System.

Procedure revisions will receive a technical review, which will include a screening for 

10 CFR 50.59 applicability, and will then be reviewed and approved as described in Part (b) of 

the SHINE response to RAI 12.3-1.

SHINE updated Section 12.3 of the PSAR to expand on the description of the applicant’s 

method for the review and approval of procedures.

On the basis of its review, the staff has determined that the level of detail provided on the 

SHINE review procedure activities is adequate for the issuance of a construction permit and 

supports the applicable acceptance criteria of NUREG -1537, Part 2, Section 12.3.

Therefore, the staff finds the information to be included in SHINE FSAR Section 12.3, as 

supplemented by the applicant’s response to an RAI, is sufficient to meet the applicable 

regulatory requirements and guidance for the issuance of a construction permit in accordance 

with 10 CFR 50.35. Further information required to complete the review may reasonably be left 

for later consideration. Following receipt of the SHINE FSAR, the staff will confirm that the 

above issues have been resolved.

Required Actions

The staff evaluated the sufficiency of the preliminary design of the SHINE required actions, as 

described in SHINE PSAR Section 12.4, using the guidance and acceptance criteria from 

Section 12.4, “Required Actions,” in NUREG-1537, Part 1 and 2.

As stated in SHINE PSAR Section 12.4, “[r]equired actions to be taken in the event of a violation 

of a facility safety limit or the occurrence of a reportable event will be developed for the FSAR.”

The staff has considered the statement in the PSAR and determined, using the guidance in 

NUREG-1537, that this information is specific to the operation of the SHINE facility, and as 

such, is not necessary for the issuance of a construction permit.

Therefore, the staff finds deferring its review on required actions, as described in SHINE 

PSAR Section 12.4, can reasonably be left for later consideration in the evaluation of the SHINE 

FSAR.

Reports

The staff evaluated the sufficiency of the preliminary design of the SHINE reports, as described 

in SHINE PSAR Section 12.5, using the guidance and acceptance criteria from Section 12.5, 

“Reports,” in NUREG-1537, Part 1 and 2.

As stated in SHINE PSAR Section 12.5, “[a] detailed discussion of reports that will be submitted 

to the NRC will be provided in the FSAR.”
Conduct of Operations

12-12

The staff has considered the statement in the PSAR and determined, using the guidance in 

NUREG-1537, that this information is specific to the operation of the SHINE facility, and as 

such, is not necessary for the issuance of a construction permit.

Therefore, the staff finds deferring its review on reports, as described in SHINE PSAR 12.5, can 

reasonably be left for later consideration in the evaluation of the SHINE FSAR.

Records

The staff evaluated the sufficiency of the preliminary design of the SHINE records, as described 

in SHINE PSAR Section 12.6, using the guidance and acceptance criteria from Section 12.6, 

“Records,” in NUREG-1537, Part 1 and 2.

As stated in SHINE PSAR Section 12.6, “[t]he SHINE records management program defines the 

process for managing SHINE records. The records management program includes the 

identification, generation, authentication, maintenance, and disposition of records. A detailed 

discussion of records management will be provided in the FSAR.”

The staff has considered the statement in the PSAR and determined, using the guidance in 

NUREG-1537, that this information is specific to the operation of the SHINE facility, and as 

such, is not necessary for the issuance of a construction permit.

Therefore, the staff finds deferring its review on records, as described in SHINE PSAR 12.6, can 

reasonably be left for later consideration in the evaluation of the SHINE FSAR.

Emergency Planning

The staff evaluated the sufficiency of the SHINE Preliminary Emergency Plan against applicable 

regulatory requirements using regulatory guidance and standards to assess the sufficiency of 

the preliminary emergency plan. 

The regulations in 10 CFR Part 50, Appendix E, Part II, “The Preliminary Safety Analysis 

Report,” (PSAR) state that the PSAR should address the site layout and location, consideration 

of access routes, surrounding population distribution, land use, and jurisdictional boundaries. 

NUREG-1537, Part 2, Chapter 12, “Conduct of Operations,” Section 12.1, “Introduction,” 

provides the guidelines for reviewing applications and references NUREG-0849 (Reference 52) 

for the review and evaluation of emergency plans at non-power reactors. The planning 

standard provided in NUREG-0849, Section 1.0, “Introduction,” calls for the emergency plan to 

provide a description of the facility – in this case the TSV - including authorized power level, 

location, and access routes to the facility. The owner and operator of the facility should be 

identified, and the objectives of the emergency plan explained.

The staff reviewed the information provided in Section 1.0, “Introduction,” of the SHINE 

Preliminary Emergency Plan, including associated figures, site layout, and maps provided in the 

application. 

In the course of reviewing the SHINE construction permit application, the NRC staff determined 

that additional information was required to prepare a safety evaluation report. In an RAI dated 

September 19, 2014 (Reference 14), the staff requested that the applicant provide a legible 

figure of the facility and/or an electronic copy that could be manipulated to facilitate resolution of 

building names/numbers and labels, roads and parking lots, site boundaries showing fences 
Conduct of Operations

12-13

and gates, major site features, access routes, and water bodies within approximately 1 mile of 

the site. 

In an October 15, 2014, response to RAI-12.7-1 (Reference 20), the applicant provided a legible 

copy of Figure 1-1 of the SHINE Preliminary Emergency Plan, including building 

names/numbers and labels, roads and parking lots, site boundaries showing fences and gates, 

and major site features, including access routes. The applicant also stated there are no bodies 

of water within one mile of the SHINE site. 

The staff reviewed the response to RAI 12.7-1 and concluded that the information provided is 

consistent with the guidelines in NUREG-0849. Therefore, this RAI is closed.

The staff finds the information in the application concerning the site layout and location, 

consideration of access routes, surrounding population distribution, land use, and jurisdictional 

boundaries, authorized power level, identification of the owner and operator of the facility, and 

an explanation of the objectives of the emergency plan are acceptable and meet the relevant 

requirements of 10 CFR Part 50, Appendix E, Section II, and the planning standard and criteria 

provided in the applicable guidance. The staff concludes that this preliminary information meets 

the applicable regulatory requirements and acceptance criteria and is therefore sufficient for the 

issuance of a construction permit. Further evaluation of this information will occur following the 

receipt of SHINE’s Final Safety Analysis Report (FSAR) submitted with the SHINE operating 

license application.

There are no specific regulatory requirements in 10 CFR 50, Appendix E, Part II, “The 

Preliminary Safety Analysis Report,” related to definitions. NUREG-1537, Part 2, Chapter 12, 

“Conduct of Operations,” Section 12.2, “Definitions,” provides the guidelines for reviewing 

applications and references NUREG-0849 for the review and evaluation of emergency plans at 

non-power reactors. Section 2.0, “Definitions,” of NUREG-0849, states that the emergency plan 

should provide definitions for terms that are unique to the facility and should include phrases 

with meanings specific to the facility. 

The staff reviewed the terms defined as having special meaning and the list of acronyms and 

abbreviations provided in the SHINE Preliminary Emergency Plan, Revision 0, and observed the 

use of these terms, acronyms, and abbreviations throughout the document.

The staff found the defined terms, acronyms, and abbreviations to be complete and used 

consistently throughout the document. The staff finds the information acceptable and 

determined that the definitions, acronyms, and abbreviations are consistent with the guidelines 

provided in NUREG-0849, Section 2.0, “Definitions.” The staff concludes that the preliminary 

information provided meets the applicable regulatory requirements and acceptance criteria and 

is therefore sufficient for the issuance of a construction permit. Further evaluation of this 

information will occur following the receipt of the SHINE FSAR and emergency plan submitted 

for the operating license.

The regulations in 10 CFR Part 50, Appendix E, Part II, Section A require a description of the 

onsite and offsite organizations for coping with emergencies and the means for notification in 

the event of an emergency, and of persons assigned to the emergency organization. The 

guidance in NUREG-0849 and NUREG-1537, Part 2, Section 3.0, “Organization and 

Responsibilities,” identifies criteria for evaluating the emergency organization including the 

onsite emergency organization and any augmentation from offsite groups, and the identification, 
Conduct of Operations

12-14

by normal everyday title, of all persons or groups that will fill positions in the emergency 

organization. These criteria include:

• A description of the emergency planning functions of Federal, State, and local 

government agencies, and identification of the assistance they would provide and of the 

applicant’s emergency organization, including augmentation of the operations staff to 

provide assistance during an emergency, recovery from the emergency, and maintaining 

emergency preparedness.

• The arrangements and written agreements with local support organizations that would 

augment and extend the capability of the facility's emergency organization.

• A block diagram illustrating the interrelationship of the facility emergency organization to 

the total emergency response effort. Specification of the interface between the onsite 

emergency organization and offsite local support organizations and agencies.

• The identification by title of the individuals in charge of directing emergency operations; 

for coordinating emergency preparedness planning, updating emergency plans and 

procedures, and coordinating plans with other supporting organizations; for relating 

information about the emergency to the news media and the public, and of the individual 

in charge of both onsite and offsite radiological assessments including a line of 

succession, and responsibilities and authorities and those responsibilities which may not 

be delegated (such as notification and protective action decisions). 

• The identification by title of the individuals providing onsite and offsite dose assessments 

and recommended protective actions, authorizing reentry into radiological controlled 

areas or portions of the facility that may have been evacuated during the emergency; 

terminating an emergency and initiating recovery actions and informing the emergency 

organization of planned organizational actions or changes, and authorizing volunteer 

emergency workers to incur radiation exposures in excess of normal occupational limits.

• The identification by title of the individuals who will declare an alert or site area 

emergency, activate the onsite ERO during all shifts, promptly notify offsite response 

authorities that an alert of site area emergency has been declared, notify the NRC 

Operations Center, initiate onsite and offsite protective actions, request support from 

offsite organizations, and either terminate the emergency or enter recovery mode.

The staff reviewed Section 3.0, “Organization and Responsibilities,” of the SHINE Preliminary 

Emergency Plan, Rev. 0, to evaluate the emergency organization, and in an RAI letter dated 

September 19, 2014 (Reference14), submitted six RAIs related to this subsection. The 

applicant’s responses to RAI 12.7-2 through 12.7-7 are contained in Reference 20. 

In RAI 12.7-2, the staff requested that the applicant clarify if letters of agreements, with 

developed procedures for emergency response with local emergency response agencies, would 

be submitted with the SHINE operating license application. In response, the applicant 

confirmed that letters of agreement with local support organizations who could augment and 

extend the capability of the facility’s emergency organization will be provided in the emergency 

plan, which will be provided as part of the SHINE operating license application. The applicant 

initiated an IMR to ensure the letters of agreement are provided. The staff finds this to be an 

acceptable response for the issuance of a construction permit. This issue has been identified 
Conduct of Operations

12-15

as a regulatory commitment in Appendix A of this SER. Following receipt of the SHINE 

Emergency Plan and FSAR prepared for the operating license, the staff will confirm that this 

issue has been resolved.

In RAI 12.7-3, the staff requested that the applicant clarify if the Operators and ERO staff 

positions will be filled by the same individuals and to describe the positions, duties, and 

responsibilities of the ERO staff. In response, the applicant stated that the positions, duties, and 

responsibilities of the ERO staff will be described in the SHINE Emergency Plan submitted with 

the SHINE operating license application. The applicant initiated an IMR to ensure the positions, 

duties, and responsibilities of the ERO staff are described in the SHINE Emergency Plan and 

provided as part of the SHINE operating license application. The staff finds this to be an 

acceptable response for the issuance of a construction permit. This issue has been identified 

as a regulatory commitment in Appendix A of this SER. Following receipt of the SHINE 

Emergency Plan and FSAR submitted with the SHINE operating license application, the staff 

will confirm that this issue has been resolved.

In RAI 12.7-4, the staff requested that the applicant describe the actions the on-shift operators 

will take if they cannot ensure that their activities can be placed in a safe condition before 

reporting to the on-site assembly area. In response to RAI 12.7-4, the applicant stated that 

equipment operators in the field would either place their activities in a safe condition or take 

whatever possible actions and report to the on-site assembly area and to the Emergency 

Director (ED).

However, the applicant’s response to RAI 12.7-4 did not address on-shift operator actions, such 

as the actions taken by the shift supervisor, senior facility operator, and facility operator. In 

follow-up RAI 12.7-35, dated January 6, 2015 (Reference 15), the staff requested that the 

applicant address the actions of the on-shift operators. In response to RAI 12.7-35 

(Reference 22), the applicant stated they would revise Section 3.3 of the SHINE Emergency 

Plan to clarify this issue. The applicant initiated an IMR to ensure the emergency plan was 

appropriately revised to address this issue. The staff is tracking this issue as a regulatory 

commitment in Appendix A of this SER. Following receipt of the SHINE Emergency Plan and 

FSAR submitted for the operating license, the staff will confirm that this issue has been 

resolved.

In RAI 12.7-36 dated March 25, 2015 (Reference 16), the staff requested that the applicant 

provide additional information on the actions on-shift operators will take if an emergency was 

declared, considering design basis, beyond design basis, security, and unplanned onsite and 

offsite events, if their activities could not be placed in a safe condition. The staff also requested 

that the applicant describe the programmatic processes for individuals as well as the safety 

systems necessary to maintain safe shutdown. In response to RAI 12.7-36 (Reference 48), the 

applicant stated they have initiated three IMRs to ensure the SHINE Emergency Plan provided 

as part of the SHINE operating license application will address these issues. The staff is 

tracking this issue as a regulatory commitment in Appendix A of this SER. Following receipt of 

the SHINE Emergency Plan and FSAR submitted for the operating license, the staff will confirm 

that these issues have been resolved.

In RAI 12.7-5, the staff requested that the applicant clarify the lines of succession for the shift 

supervisor if the shift supervisor is acting as the ED. In response to RAI 12.7-5, the applicant 

clarified that the senior licensed operator onsite will assume the role. The staff finds the 

response to be acceptable for the issuance of a construction permit. 
Conduct of Operations

12-16

In RAI 12.7-6, the staff requested that the applicant describe a line of succession for the 

responsibilities of the Emergency Preparedness Manager. In response to RAI 12.7-6, the 

applicant clarified that the Emergency Preparedness Manager is part of the SHINE 

management team and the responsibilities are outside the actual ERO framework and no line of 

succession will be required. The applicant stated that the Emergency Preparedness Manager is 

responsible for overall emergency plan maintenance and coordination, and that this position 

could respond to emergencies as part of the ERO. The staff finds the response to be 

acceptable for the issuance of a construction permit.

In RAI 12.7-7, the staff noted that the applicant did not include the Emergency Preparedness 

Manager in organization charts. In response to RAI 12.7-7, the applicant clarified that the 

responsibilities of the Emergency Preparedness Manager fits within the Chief Operating 

Officer‘s (COO’s) chain of command, but there is no direct reporting relationship to the COO. 

The applicant also clarified that the Emergency Preparedness Manager is not in the line of 

succession for the ED. The staff finds this to be an acceptable response for the issuance of a 

construction permit

Emergency planning is programmatic and the information in this subsection pertains to the 

operations of the SHINE facility. Specific details regarding the organization and responsibilities 

are not necessary for the issuance of a construction permit. In the responses to RAIs 12.7-2, 

RAI 12.7-3, and RAIs 12.7-4/RAI 12.7-35, the applicant has stated it would provide additional 

information regarding the organization and responsibilities in the SHINE Emergency Plan and 

FSAR submitted with the operating license application. Therefore, the staff has deferred a more 

detailed evaluation of this subsection until receipt of the SHINE Emergency Plan and FSAR 

supporting an operating license. Following receipt of the SHINE Emergency Plan and FSAR for 

the operating license, staff will confirm that these issues have been resolved. The regulatory 

commitments for the emergency plan and FSAR related to this subject are briefly summarized 

below:

• The SHINE Emergency Plan provided as part of the SHINE operating license application 

will include letters of agreement made with local support organizations. 

• The SHINE Emergency Plan provided as part of the SHINE operating license application 

will describe the positions, duties, and responsibilities of the ERO staff.

• The SHINE Emergency Plan, Section 3.3 will be revised to clarify the actions that 

on-shift operators will take if they cannot ensure their activities can be placed in a safe 

condition before reporting to on-site assembly areas. 

• The SHINE Emergency Plan provided with the SHINE operating license application will 

describe the actions on-shift operators will take if their activities cannot be placed in a 

safe condition considering a design basis, beyond design-basis, security, and unplanned 

events. The SHINE Emergency Plan will also address the programmatic process for 

individuals to follow, as well as the safety systems necessary to maintain safe shutdown 

in the event of an emergency.

Based on the discussion above, the staff concludes that the information provided in the SHINE 

Preliminary Emergency Plan, Rev. 0, Section 3.0, “Organization and Responsibility,” is sufficient 

for the issuance of a construction permit. Further evaluation of this subsection will occur 
Conduct of Operations

12-17

following the receipt of the SHINE Emergency Plan and FSAR submitted with the operating 

license application.

The regulations in 10 CFR Part 50, Appendix E, Part II, require that a PSAR provide sufficient 

information to ensure the compatibility of the proposed emergency plan with onsite areas and 

the proposed design features. Section C requires that protective measures be taken within the 

site boundary to protect health and safety in the, event of an accident. Section H requires a 

preliminary analysis reflecting the need to include methods for identifying the degree of 

seriousness and potential scope of radiological consequences of emergency situations within 

and outside the site boundary and assessing/recommending protective actions. 

The acceptance criteria in NUREG- 0849, Section 4.0, “Emergency Classification System,” and 

from NUREG-1537, Part 2, Section 12.7, “Emergency Planning,” Sub-section 4.0, “Emergency 

Classification System,” state, in part, that the emergency plan should contain:

• An emergency classification system consistent with the planning standard.

• The emergency plan implementing procedures (EPIPs) should be contained in an 

appendix to the emergency plan. 

• The emergency plan should include both an alert and site area emergency classification.

• The emergency plan should identify the classification of each accident identified in the 

emergency plan.

The staff reviewed Section 4.0, “Emergency Classification System,” of the SHINE preliminary 

Emergency Plan which states the classification scheme will be based on three guidance 

documents (Regulatory Guide 2.6 [Reference 53], ANSI/ANS-15.16-2008 [Reference 56], and 

NUREG-0849 [Reference 52]), will cover the range of events described in Chapter 13 of the 

PSAR and that a listing of EPIPs, by title, will be provided with the FSAR. In RAI 12.7-8, dated 

September 19, 2014 (Reference 14), the staff requested that the applicant provide a listing by 

title, and description, of implementing procedures for each class of emergency consistent with

NUREG-0849 or to explain why this information is not necessary. In response to RAI 12.7-8 

(Reference 20), the applicant stated that it would provide an Appendix to the Emergency Plan, 

listing by title, with description, EPIPs for each class of emergency in the SHINE Emergency 

Plan provided as part of the SHINE operating license application. The staff finds this to be an 

acceptable response for the issuance of a construction permit. The applicant initiated an IMR to 

ensure an appendix containing a listing of EPIPs with descriptions for each class of emergency 

is provided with the SHINE Emergency Plan submitted for the SHINE operating license 

application. The staff is tracking this issue as a regulatory commitment in Appendix A of this 

SER. 

Emergency planning is programmatic and the information in this subsection pertains to the 

operations of the SHINE facility. While specific details regarding the emergency classification 

scheme are not necessary for the issuance of a construction permit, RAIs were necessary to 

confirm the adequacy of the scope of information provided in the preliminary emergency plan. 

In the response to RAI 12.7-8, the applicant stated it will provide an Appendix to the SHINE 

Emergency Plan submitted with the operating license application that lists, by title, with 

description, the EPIPs for each class of emergency. Therefore, the staff has deferred a more 

detailed evaluation of this subsection until receipt of the SHINE Emergency Plan and FSAR 
Conduct of Operations

12-18

supporting an operating license. SHINE’s regulatory commitment is being tracked to ensure 

that EPIPs are provided. Following receipt of the SHINE Emergency Plan and FSAR for the 

operating license, staff will confirm that this issue has been resolved. The regulatory 

commitment for the emergency plan related to this subject is briefly summarized below:

• The SHINE Emergency Plan provided as part of the SHINE operating license application 

will include an appendix to the emergency plan that lists the EPIPs by title and 

description.

The staff concludes that the information provided in the SHINE Preliminary Emergency Plan, 

Rev. 0, Section 4.0, “Emergency Classification System,” is not necessary to meet regulatory 

requirements and acceptance criteria for the issuance of a construction permit. Further 

evaluation of this subsection will occur following the receipt of the SHINE Emergency Plan and 

FSAR submitted with the SHINE operating license application.

The regulations in 10 CFR Part 50, Appendix E, Part II, Section H require a preliminary analysis 

reflecting the need to include methods for identifying the degree of seriousness and potential 

scope of radiological consequences of emergency situations within and outside the site 

boundary and assessing recommended protective actions. 

The acceptance criteria in NUREG-0849, Section 5.0, “Emergency Action Levels,” and from 

NUREG-1537, Part 2, Section 12.7, “Emergency Planning,” Sub-section 5.0, “Emergency Action 

Levels,” state, in part, that:

• The emergency action levels (EALs) should be appropriate to the specific facility and 

consistent with the emergency classes discussed in Section 12.7.4, and to the extent 

possible, specify the effluent monitors used to project dose rates and radiological 

effluent releases at the site boundary.

• The EALs should be comparable to the U.S. Environmental Protection Agency’s 

protective action guides (PAGs) described in EPA 400-R-92-001.

The staff reviewed Section 5.0, “Emergency Action Levels,” of the SHINE Preliminary 

Emergency Plan and submitted three RAIs (Reference 14) related to EALs. The applicant’s 

responses to RAI 12.7-9 through 12.7-11 are contained in Reference 20. 

In RAI 12.7-9, the staff requested that the applicant explain why an inadvertent criticality event 

in an unshielded area was not considered in the accident analyses. In its response, the 

applicant clarified its approach to the consideration of a criticality event regardless of whether 

the accident occurs inside or outside a shielded area and committed to revise Table 5-1, 

“Postulated Accidents for the SHINE Facility Emergency Classification, Maximum Off-site and 

Worker Dose, and Corresponding Emergency Action Level,” as appropriate. The staff finds this 

to be an acceptable response for the issuance of a construction permit and is tracking this issue 

as a regulatory commitment in Appendix A of this SER. Following receipt of the SHINE 

Emergency Plan and FSAR submitted for the operating license, the staff will confirm that this 

issue has been resolved.

In RAI 12.7-10, the staff noted that Table 5-1 did not include a full list of EALs for each accident 

condition and requested that the applicant confirm that Table 5-1 would be provided with a full 

list of EALs for each accident condition. In response to RAI 12.7-10, the applicant committed to 

revise Table 5.1 to include a full list of EALs for each accident condition, in the SHINE 
Conduct of Operations

12-19

Emergency Plan submitted for the SHINE operating license application. The staff finds this to 

be an acceptable response for the issuance of a construction permit and is tracking this issue as 

a regulatory commitment in Appendix A of this SER. Following receipt of the SHINE Emergency 

Plan and FSAR submitted for the operating license, the staff will confirm that this issue has 

been resolved.

In RAI 12.7-11, the staff requested that the applicant specify effluent monitors that would be 

used to project dose rates and radiological effluent releases and include EALs to initiate 

protective actions per the guidance in NUREG-0849. In response to RAI 12.7-11, the applicant 

stated that the specific values/setpoints used for emergency classification will be provided in the 

SHINE Emergency Plan submitted as part of the SHINE operating license application. The 

applicant initiated an IMR to ensure the specific values/setpoints are provided with the SHINE 

Emergency Plan, submitted with the SHINE operating license application. The staff finds this to 

be an acceptable response for the issuance of a construction permit and is tracking this issue as 

a regulatory commitment in Appendix A of this SER. Following receipt of the SHINE Emergency 

Plan and FSAR submitted with the SHINE operating license application, staff will confirm that 

this issue has been resolved.

Emergency planning is programmatic and the information in this subsection pertains to the 

operations of the SHINE facility. While specific details regarding the EALs are not necessary for

the issuance of a construction permit, RAIs were necessary to confirm the adequacy of the 

scope of information provided in the preliminary emergency plan. In the responses to RAI 

12.7-9, 12.7-10, and 12.7-11, the applicant has stated it will revise the SHINE Emergency Plan 

submitted with the operating license application to consider a criticality event, to identify EALs 

for each identified accident condition, and to identify specific values/set points. Therefore, the 

staff has deferred a more detailed evaluation of this subsection until receipt of the SHINE 

Emergency Plan and FSAR supporting an operating license. SHINE’s regulatory commitments 

are being tracked to ensure these issues are resolved in the emergency plan and FSAR 

submitted for the operating license. Following receipt of the SHINE Emergency Plan and FSAR 

for the operating license, the staff will confirm that these issues have been resolved. The 

regulatory commitments for the emergency plan related to this subject are briefly summarized 

below:

• The SHINE Emergency Plan provided as part of the SHINE operating license application 

will include a revised Table 5-1 that considers a criticality event.

• The SHINE Emergency Plan provided as part of the SHINE operating license application 

will include a revised Table 5.1, “Postulated Accidents for the SHINE Facility, 

Emergency Classification, Maximum Off-site and Worker Dose, and Corresponding 

Emergency Action Level,” that provides a full list of EALs for each accident condition.

• The SHINE Emergency Plan provided as part of the SHINE operating license application 

will provide specific values/setpoints for emergency classification. 

The staff concludes that the information provided in the SHINE Preliminary Emergency Plan, 

Revision 0, Section 5.0, “Emergency Action Levels,” is not necessary to meet regulatory 

requirements and acceptance criteria for the issuance of a construction permit. Further 

evaluation of this subsection will occur following the receipt of the SHINE Emergency Plan and 

FSAR submitted with the SHINE operating license application.
Conduct of Operations

12-20

The regulations in 10 CFR Part 50, Appendix E, Part II, Section H require a preliminary analysis 

reflecting the need to include methods for identifying the degree of seriousness and potential 

scope of radiological consequences of emergency situations within and outside the site 

boundary, including the capabilities for dose projection and dispatch of radiological monitoring 

teams within the EPZs. 

The acceptance criteria from NUREG- 0849, Section 6.0 for the “Emergency Planning Zones,” 

NUREG-1537, Part 2, Section 12.7, “Emergency Planning,” Section 6.0, “Emergency Planning 

Zones,” and in Regulatory Guide 2.6 supplementing ANSI/ANS-15.16-2008, Section 3.6 state,

in part, that: 

• The emergency plan should identify the EPZ.

• The emergency plan should provide an acceptable basis for the EPZ.

• The size of the EPZ should be established so that the dose to individuals beyond the 

EPZ is not projected to exceed the PAGs.

The potential radiological hazards to the public associated with the operation of research and 

test reactors and fuel facilities licensed under 10 CFR Part 50 involve considerations different 

than those associated with nuclear power reactors. As endorsed by Regulatory Guide 2.6, 

ANSI/ANS-15.16 describes an acceptable approach for emergency planning commensurate 

with the potential risk involved for facilities of various authorized power level. This approach to 

an acceptable EPZ size is also described in NUREG-0849, Appendix II, and was adopted by the 

applicant.

The staff reviewed Section 6.0, “Emergency Planning Zones,” of the SHINE preliminary 

Emergency Plan, which states the applicant could not define a credible accident scenario that 

would result in radiological emergencies that involve an off-site plume exposure exceeding 

1 rem whole body or 5 rem thyroid. Therefore, the applicant did not identify EPZs for the SHINE 

facility. 

In RAI 12.7-12 dated September 19, 2014 (Reference 14), the staff noted that the applicant had 

not identified the size of the EPZ consistent with the criteria in the cited guidance in 

ANSI/ANS-15.16 and in NUREG-0849. In response to RAI 12.7-12 (Reference 21), the 

applicant responded by stating, in part, that:

SHINE has performed calculations as part of the accident analysis, and the 

calculation results are described in Chapter 13 of the PSAR. SHINE has 

concluded that the radiological releases and consequences to workers and the 

public are maintained within 10 CFR 20 limits (i.e., 100 millirem to the general 

public and five rem to the worker). For this reason, Section 6.0 of the SHINE 

Preliminary Emergency Plan [Reference 3] states, in part, that:

“As described in Chapter 13 of the SHINE PSAR (Reference 11.8), no 

credible accident scenarios at the SHINE facility result in radiological 

emergencies that involve an off-site plume exposure exceeding 1 rem 

whole body or 5 rem thyroid. Therefore, in accordance with ANSI/ANS15.16-2008 (Reference 11.1) and NUREG-0849 (Reference 11.3), no 

EPZs have been identified for the SHINE facility.”

Based on the above information, SHINE concludes that an emergency planning 

zone (EPZ) is not required at the SHINE facility, and the guidance and 
Conduct of Operations

12-21

information contained in ANSI/ANS-15.16-2008 and NUREG-0849 align with this 

position. There is no radiological emergency which would result in off-site plume 

exposures exceeding one rem whole body or five rem thyroid. 

The staff understands the applicant’s position that there may not be a radiological emergency 

resulting in an off-site plume that would exceed the criteria established for establishing an EPZ 

beyond the operational site boundary. However, consistent with the guidance in 

ANSI/ANS-15.16, for a facility with the anticipated authorized power level of the SHINE facility,

an acceptable EPZ size would be the operational boundary. For the purposes of issuing a 

construction permit, the staff finds it sufficient for SHINE to adequately describe the 

considerations used to determine the EPZ for the site. The staff will further evaluate SHINE’s 

characterization of its EPZ following the guidance in ANSI/ANS-15.16 after the receipt of the 

SHINE Emergency Plan and FSAR supporting an operating license. 

Emergency planning is programmatic and the information in this subsection pertains to the 

operations of the SHINE facility. While the specific details regarding the emergency planning 

zone are not necessary for the issuance of a construction permit, RAIs were necessary to 

confirm the adequacy of the scope of information provided in the preliminary emergency plan. 

Therefore, the staff has deferred a more detailed evaluation of this subsection until receipt of the 

SHINE Emergency Plan and FSAR supporting an operating license application.

The staff concludes that the information provided in the SHINE Preliminary Emergency Plan, 

Revision 0, Section 6.0, “Emergency Planning Zones,” of the SHINE preliminary Emergency 

Plan,” is not necessary to meet regulatory requirements and acceptance criteria for the issuance 

of a construction permit. Further evaluation of this subsection will occur following the receipt of 

the SHINE Emergency Plan and FSAR submitted with the SHINE operating license application. 

The regulations in 10 CFR 50 Appendix E, Part II, “The Preliminary Safety Analysis Report,” 

Sections C, D, and E, require that emergency response measures be identified for each 

emergency. These response measures should be related to the emergency class and action 

levels that specify what measures are to be implemented. NUREG-1537, Part 2, Chapter 12, 

“Conduct of Operations,” Section 12.7, “Emergency Response,” provides the guidelines for 

reviewing applications and references NUREG-0849, which provides the guidelines for the 

review and evaluation of emergency plans at non-power reactors. In particular, NUREG-0849, 

Section 7.0, “Emergency Response,” provides criteria for emergency response measures that 

should be identified for each emergency. NUREG-0849 and NUREG-1537, Part 2, acceptance 

criteria included the review and evaluation of:

• The notification information for emergency response including the actions to notify and 

mobilize the emergency organization and the applicable offsite support organizations for 

each emergency class and the location of current notification lists. Initial and follow-up 

emergency messages to the NRC and to offsite authorities, as applicable, should 

include: caller information such as name, title, and telephone number, a description of 

the emergency event, date and time of incident initiation, the location of the incident and 

the emergency class, quantity and type of radionuclides released or expected to be 

released, and the impact of releases and recommended offsite emergency actions. A 

method to ensure that offsite authorities have received the initial message and that it is 

authentic and that appropriate follow-up messages to offsite authorities are issued 

promptly. 
Conduct of Operations

12-22

• The methods for gathering and processing information for assessment actions should be 

described in the emergency plan, and PAGS are available and used by the appropriate 

personnel in a timely manner.

• The actions that could be taken to mitigate or correct the problem for each emergency 

class should be summarized in the emergency plan.

• The emergency plan should describe protective actions appropriate for the emergency 

class and should include: conditions for either partial or complete onsite evacuation, 

evacuation routes, and primary and alternate assembly areas; methods to ensure 

personnel accountability and the segregation of potentially contaminated personnel; 

protective measures and exposure guidelines for emergency personnel; provisions for 

isolating and access control of facility areas to minimize exposures to radiation and the 

spread of radioactive contamination; and the methods for monitoring radiation dose rates 

and contamination levels, both onsite and offsite, including provisions for transmitting 

collected information and data to those responsible for accident assessment.

• The emergency plan should describe the ability to promptly and effectively assess a 

release of radioactive material or hazardous chemicals including a description of 

procedures for estimating or measuring the release rate or source term; a description of 

the computer codes used to project doses along with supporting justifications, and 

discuss the validity of assumptions, and describe the method for assessing collateral 

damage to the facility.

The staff reviewed Section 7.0, “Emergency Response,” of the SHINE Emergency Plan to 

evaluate the applicant’s emergency preparedness, and in an RAI dated September 19, 2014 

(Reference 14), submitted nine RAIs related to this subsection. The staff determined that the 

applicant did not adequately describe emergency response measures for each class of 

emergency and specify what measures should be implemented to promptly and effectively 

assess the release of radioactive material or hazardous chemicals. The applicant’s responses 

to RAI 12.7-13 through 12.7-21 are contained in Reference 20. 

In RAI 12.7-13, the staff requested that the applicant clarify who has the responsibility to classify 

an emergency event and to incorporate the clarification into the next revision of the SHINE 

Emergency Plan. In response to RAI 12.7-13, the applicant stated that the ED has the 

responsibility to classify an emergency event, and that clarifying language will be provided in the 

SHINE Emergency Plan submitted with the SHINE operating license application. The applicant 

initiated an IMR to ensure the clarifying language is provided in the SHINE Emergency Plan. 

The staff finds this to be an acceptable response for the issuance of a construction permit. This 

issue has been identified as a regulatory commitment in Appendix A of this SER. Following 

receipt of the SHINE Emergency Plan and FSAR, the staff will confirm that this issue has been 

resolved.

In RAI 12.7-14, the staff requested a summary description of those actions that the applicant 

could take to mitigate or correct the problem for each emergency class. In response to RAI 

12.7-14, the applicant stated that a summary description of those actions that could be taken to 

mitigate or correct the problem for each class of emergency will be provided with the SHINE 

Emergency Plan, provided as part of the SHINE operating license application. The applicant 

initiated an IMR to ensure the summary descriptions are provided in the SHINE Emergency 

Plan. The staff finds this to be an acceptable response for the issuance of a construction 
Conduct of Operations

12-23

permit. This issue has been identified as a regulatory commitment in Appendix A of this SER. 

Following receipt of the SHINE Emergency Plan and FSAR submitted for the operating license, 

the staff will confirm that this issue has been resolved. 

In RAI 12.7-15, the staff requested that the applicant describe the method(s) to assess collateral 

damage to the facility. In response to RAI 12.7-15, the applicant stated they will describe the 

methods for assessing collateral damage to the SHINE facility in the SHINE Emergency Plan 

submitted with the SHINE operating license application. The applicant initiated an IMR to 

ensure the methods for assessing collateral damage to the facility are described in the SHINE 

Emergency Plan. The staff finds this to be an acceptable response for the issuance of a 

construction permit. This issue has been identified as a regulatory commitment in Appendix A of 

this SER. Following receipt of the SHINE Emergency Plan and FSAR submitted for the 

operating license, the staff will confirm that this issue has been resolved. 

In RAI 12.7-16, the staff requested that the applicant confirm that alternate assembly areas and 

evacuation routes will be provided in the FSAR. In response to RAI 12.7-16, the applicant 

clarified that alternate assembly areas and evacuation routes will be identified in the SHINE 

Emergency Plan, provided as part of the SHINE operating license application. The staff finds 

this to be an acceptable response for the issuance of a construction permit. This issue has 

been identified as a regulatory commitment in Appendix A of this SER. Following receipt of the 

SHINE Emergency Plan and FSAR, staff will confirm that this issue has been resolved. No IMR 

was initiated by the applicant.

In RAI 12.7-17, the staff requested that the applicant describe the “contamination controls” that 

will be in place throughout the facility and in close proximity to a contaminated area, or describe 

where this information can be found in the emergency plan. In response to RAI 12.7-17, the 

applicant stated that they will include this information in the SHINE Emergency Plan submitted 

with the SHINE operating license application. The applicant initiated an IMR to ensure that 

contamination controls are described in the SHINE Emergency Plan. The staff finds this to be 

an acceptable response for the issuance of a construction permit. This issue has been 

identified as a regulatory commitment in Appendix A of this SER. Following receipt of the 

SHINE Emergency Plan and FSAR submitted for the operating license, the staff will confirm that 

this issue has been resolved.

In RAI 12.7-18, the staff requested that the applicant define the thresholds for categorizing 

personnel being surveyed and evacuated through control points as “contaminated” and 

“decontaminated” before release. In response to RAI 12.7-18, the applicant stated that these 

thresholds will be defined in the SHINE EPIPs. The applicant initiated an IMR to ensure that the 

thresholds to categorize personnel being surveyed and evacuated through control points as 

“contaminated,” and to be decontaminated before release, is defined in the SHINE EPIPs. The 

staff finds this to be an acceptable response for the issuance of a construction permit. This 

issue has been identified as a regulatory commitment in Appendix A of this SER. Following 

receipt of the SHINE Emergency Plan and FSAR, staff will confirm that this issue has been 

resolved.

In RAI 12.7-19, the staff requested that the applicant describe protective measures and 

exposure guidelines for emergency personnel. In response to RAI 12.7-19, the applicant stated 

they will include protective measures and exposure guidelines for emergency personnel in the 

SHINE Emergency Plan submitted with the SHINE operating license application. The applicant 

initiated an IMR to track the inclusion of protective measures and exposure guidelines for 

emergency personnel in the SHINE Emergency Plan. The staff finds this to be an acceptable 
Conduct of Operations

12-24

response for the issuance of a construction permit. This issue has been identified as a 

regulatory commitment in Appendix A of this SER. Following receipt of the SHINE Emergency 

Plan and FSAR, the staff will confirm that this issue has been resolved.

In RAI 12.7-20 the staff requested that the applicant describe the methods that would be used to 

transmit radiation dose rates and contamination levels to onsite and offsite individuals involved 

in accident assessment. In response to RAI 12.7-20, the applicant stated that the methods for 

transmitting radiation dose rates and contamination levels onsite and offsite to those personnel 

involved in accident assessment will be described in the SHINE Emergency Plan submitted with 

the SHINE operating license application. The applicant initiated an IMR to ensure a description 

of these methods is provided in the SHINE Emergency Plan. The staff finds this to be an 

acceptable response for the issuance of a construction permit. This issue has been identified 

as a regulatory commitment in Appendix A of this SER. Following receipt of the SHINE 

Emergency Plan and FSAR submitted for the operating license, the staff will confirm that this 

issue has been resolved.

In RAI 12.7-21, the staff requested that the applicant provide the valid computer code(s) that will 

be used to project doses or concentrations to the public or environment including the 

assumptions made for purposes of analysis and the supporting justification. In response to RAI 

12.7-21, the applicant stated that they do not plan to provide real-time dose projections. The 

applicant clarified that actual indications from installed instruments will be used for emergency 

classifications. Dose projections will be based on worst-case accident scenarios/calculations. 

The staff finds this to be an acceptable response for the issuance of a construction permit. 

Following receipt of the SHINE Emergency Plan and FSAR, the staff will confirm that this issue 

has been resolved.

Emergency planning is programmatic and the information in this subsection pertains to the 

operations of the SHINE facility. Therefore, while specific details regarding emergency 

response are not necessary for the issuance of a construction permit, RAIs were necessary to 

confirm the adequacy of the scope of information provided in the preliminary emergency plan. 

In the responses to RAIs 12.7-13 through RAI 12.7-21, the applicant states that it will provide 

additional information regarding emergency response in the SHINE Emergency Plan and FSAR 

submitted with the operating license application. Therefore, the staff has deferred a more 

detailed evaluation of this subsection until receipt of the SHINE Emergency Plan and FSAR 

supporting the application for an operating license. These issues are being tracked as

regulatory commitments in Appendix A of this SER. Following receipt of the SHINE Emergency 

Plan and FSAR for the operating license, the staff will confirm that these issues have been 

resolved. The regulatory commitments for the emergency plan and FSAR related to this subject 

are briefly summarized below:

• The SHINE Emergency Plan submitted for the operating license will be revised to clarify 

that the ED will have the responsibility to declare an emergency event. 

• The SHINE Emergency Plan submitted for the operating license will describe those 

actions that could be taken to mitigate or correct the problem for each class of 

emergency.

• The SHINE Emergency Plan submitted for the operating license will be revised to 

describe the methods for assessing collateral damage to the SHINE facility. 
Conduct of Operations

12-25

• The SHINE Emergency Plan submitted for the operating license will describe the 

contamination controls used throughout the facility and in close proximity to a 

contaminated area.

• The applicant stated that the EPIPs will define the threshold to categorize surveyed 

personnel evacuated through control points as “contaminated,” and to be 

decontaminated prior to release in accordance with Section V of Appendix E to 

10 CFR 50 and the EPIPs. 

• The SHINE Emergency Plan submitted for the operating license will include protective 

measures and exposure guidelines for emergency personnel. 

• The SHINE Emergency Plan submitted for the operating license will describe the 

methods for transmitting radiation dose rates and contamination levels to both onsite 

and offsite accident assessment personnel.

The staff finds that the information provided in the SHINE Preliminary Emergency Plan, 

Revision 0, Section 7.0, “Emergency Response,” is not necessary to meet regulatory 

requirements and acceptance criteria for the issuance of a construction permit. Further 

evaluation of this subsection will occur following the receipt of the SHINE Emergency Plan and 

FSAR submitted for the operating license application.

The regulations in 10 CFR Part 50, Appendix E, Part II, require that a PSAR provide sufficient 

information to ensure the proposed emergency plan is compatible with proposed design 

features. Section H requires there is an onsite facility for use in assessing the consequences of 

a potential radiological accident. The acceptance criteria for information on emergency facilities 

and equipment from NUREG-0849 are:

• The emergency plan describes an ESC.

• Representative types of monitoring and sampling equipment that would be used for 

accident assessment and their location are described. For each type of accident 

identified, the emergency plan should describe the means of detecting the accident, the 

means of detecting any release of radioactive material or hazardous chemicals incident 

to the processing of licensed material, and the means of alerting operating staff.

• The sampling and monitoring equipment types should include portable and fixed 

radiation monitors, sampling equipment, equipment for personnel monitoring, equipment 

for specific radionuclide identification and analysis, and to assess the release to the 

environment of radioactive or hazardous chemicals incident to the processing of license 

material. The plan should also describe nonradiological monitors or indicators such as 

fire detectors, earthquake sensors, etc.

• The emergency plan should identify those measures that would be used to provide 

assistance to injured persons or those exposed to radiation. The capability to 

decontaminate, administer first aid, transport injured personnel, and arrange for 

treatment should be described including a description of both onsite and offsite services 

that support emergency response such as first aid personnel, firefighters, law 

enforcement assistance, and ambulance service. A list and description of both onsite 

and offsite emergency facilities, by location and purpose should be provided.
Conduct of Operations

12-26

• The emergency plan should identify the emergency communications systems that would 

be available to communicate instructions and information both onsite and offsite 

throughout the course of an emergency.

The staff reviewed Section 8.0, “Emergency Facilities and Equipment,” of the SHINE 

Preliminary Emergency Plan to ensure emergency facilities and equipment will be available, and 

in an RAI dated September 19, 2014 (Reference 14), submitted seven RAIs related to this 

subsection. The applicant’s responses to RAI 12.7-22 through 12.7-28 are contained in 

Reference 20. 

In RAI 12.7-22, the staff requested a more complete description of the ESC since Sections 7.2.2 

and 8.2 of the SHINE Preliminary Emergency Plan, Rev. 0, do not clearly describe whether the 

ESC is either a fixed area or mobile, nor were the capabilities and equipment described. In 

response to RAI 12.7-22, the applicant stated they will provide a more complete description of 

the ESC including its primary location, back-up location, capabilities, equipment, and size in the 

SHINE Emergency Plan to be submitted as part of the SHINE operating license application. 

The staff finds this to be an acceptable response for the issuance of a construction permit. The 

applicant initiated an IMR for this topic and the staff has identified this as a regulatory 

commitment in Appendix A of this SER. Following receipt of the SHINE Emergency Plan and 

FSAR, the staff will confirm that this issue has been resolved.

In RAI 12.7-23, the staff requested that the applicant describe the means of detecting accident 

conditions, the means of detecting any release of radioactive material or hazardous materials, 

and the means of alerting the operations staff of an accident. The staff asked the applicant to 

confirm that for each accident identified in Table 5-1 of the SHINE Preliminary Emergency Plan, 

Revision 0, the means of detecting accident conditions, the means of detecting any release of

radioactive material or hazardous materials, and the means of alerting the operations staff of the 

accident conditions be provided in the FSAR. In response to RAI 12.7-23, the applicant stated 

that for each accident identified in Table 5.1 of the SHINE Preliminary Emergency Plan, the 

applicant will provide the means of detecting accident conditions, the means of detecting 

release of either radioactive or hazardous materials, and the means of alerting the operations 

staff of the accident conditions with the FSAR. The staff finds this to be an acceptable response 

for the issuance of a construction permit. The applicant initiated an IMR for this topic to update 

the SHINE Emergency Plan to include the requested information. The staff has identified this 

as a regulatory commitment in Appendix A of this SER. Following receipt of the SHINE 

Emergency Plan and FSAR, staff will confirm that this issue has been resolved.

In RAI 12.7-24, the staff requested that the applicant describe in the emergency plan the 

specific facility locations of first aid equipment. In response to RAI 12.7-24, the applicant stated 

they will describe the locations of first aid equipment in the SHINE Emergency Plan provided as 

part of the SHINE operating license application. The staff finds this to be an acceptable 

response for the issuance of a construction permit. The applicant initiated an IMR for this topic 

to ensure the location of first aid equipment is described in the SHINE Emergency Plan. The 

staff has identified this as a regulatory commitment in Appendix A of this SER. Following 

receipt of the SHINE Emergency Plan and FSAR for the operating license, the staff will confirm 

that this issue has been resolved.

RAI 12.7-25 requested that the applicant identify the facilities, and to provide the written letters 

of agreement with hospitals to ensure the medical staff is prepared to handle radiological 

emergencies. In response to RAI 12.7-25, the applicant stated they will identify the facilities in 

which arrangements have been made to ensure that medical services are available and that the 
Conduct of Operations

12-27

medical staff are prepared to handle radiological emergencies in the emergency plan submitted 

with the SHINE operating license application. The staff finds this to be an acceptable response 

for the issuance of a construction permit. The applicant initiated an IMR to ensure the facilities 

are identified and written agreements are provided as part of the SHINE operating license

application. The staff is tracking this item as a regulatory commitment in Appendix A of this 

SER. Following receipt of the SHINE Emergency Plan and FSAR, the staff will confirm that this 

issue has been resolved.

In RAI 12.7-26, the staff requested that the applicant describe who will be responsible for 

decontaminating an ambulance, medical personnel, and the medical facility and identify the 

procedures, and their location, that will be used for decontamination of emergency medical 

services/equipment/personnel. In response to RAI 12.7-26, the applicant stated they will 

identify the responsible person and the location of procedures for decontamination of 

emergency medical services/equipment/personnel in the SHINE Emergency Plan, provided as 

part of the SHINE operating license application. The staff finds this to be an acceptable 

response for the issuance of a construction permit. The applicant initiated an IMR for this topic 

which the staff is tracking as a regulatory commitment in Appendix A of this SER. Following 

receipt of the SHINE Emergency Plan and FSAR, staff will confirm that this issue has been 

resolved

In RAI 12.7-27, the staff requested that the applicant confirm that a description of the backup 

off-site communications system be provided in the FSAR. In response to RAI 12.7-27, the 

applicant stated they will provide a description of the backup off-site communications system in 

the SHINE Emergency Plan provided as part of the SHINE operating license application. The 

staff finds this to be an acceptable response for the issuance of a construction permit. The staff 

is tracking this issue as a regulatory commitment in Appendix A of this SER. Following receipt 

of the SHINE Emergency Plan and FSAR, the staff will confirm that this issue has been 

resolved.

The SHINE Preliminary Emergency Plan, Revision 0, Section 8.6, “Contingency Planning,” 

addresses arrangements made with alternate facilities and sources of alternate equipment. In 

RAI 12.7-28 the staff requested that the applicant confirm that arrangements will have been 

made with alternate facilities and to ensure the availability of equipment from multiple sources. 

In the response to RAI 12.7-28, the applicant stated they will confirm that arrangements have 

been made with alternate facilities and that sources of alternate equipment are available, if 

needed, in the SHINE Emergency Plan submitted as part of the operating license application. 

The staff finds this to be an acceptable response for the issuance of a construction permit. The 

applicant initiated an IMR for this topic. The staff is tracking this issue as a regulatory 

commitment in Appendix A of this SER. Following receipt of the SHINE Emergency Plan and 

FSAR, staff will confirm that this issue has been resolved.

Emergency planning is programmatic and the information in this subsection pertains to the 

operations of the SHINE facility. While specific details regarding emergency facilities and 

equipment are not necessary for the issuance of a construction permit, RAIs were necessary to 

confirm the adequacy of the scope of information provided in the preliminary emergency plan. 

In the response to RAIs 12.7-22 through RAI 12.7-28, the applicant has stated it will provide 

additional information regarding emergency facilities and equipment in the SHINE Emergency 

Plan and FSAR submitted with the operating license application. Therefore, the staff has 

deferred a more detailed evaluation of this subsection until receipt of the SHINE Emergency 

Plan and FSAR supporting an operating license. Following receipt of the SHINE Emergency 

Plan and FSAR for the operating license, staff will confirm that these issues have been 
Conduct of Operations

12-28

resolved. The regulatory commitments for the emergency plan and FSAR related to this subject 

are briefly summarized below:

• The SHINE Emergency Plan submitted as part of the operating license will provide a 

complete description of the ESC including its primary location, back-up location, 

capabilities, and size.

• Table 5.1 of the SHINE Emergency Plan will be revised to provide the means of 

detecting accident conditions, the means of detecting a release of either radioactive or 

hazardous materials, and the means of alerting the operations staff of the accident 

conditions.

• The SHINE Emergency Plan submitted as part of the operating license application will 

specifically describe the location of first aid equipment.

• The applicant will confirm that arrangements have been made with alternate facilities, 

and ensure alternate sources of equipment as part of the SHINE operating license

application.

• The SHINE Emergency Plan submitted as part of the operating license application will 

describe both who has the responsibility for decontaminating an ambulance, medical 

personnel, and medical facility, and the location of the procedures for decontamination of 

emergency medical services/equipment/personnel. [No IMR initiated by applicant].

• The SHINE Emergency Plan submitted as part of the operating license application will 

describe the backup off-site communications system.

• The SHINE Emergency Plan submitted as part of the operating license application will 

include written Letters of Agreement with alternate facilities that will describe services, 

equipment, and provisions to be provided in the event of an emergency.

The staff concludes that the information provided in the SHINE Preliminary Emergency Plan, 

Rev. 0, Section 8.0, “Emergency Facilities and Equipment,” is not necessary to meet regulatory 

requirements and acceptance criteria for the issuance of a construction permit. Further 

evaluation of this information will occur following the receipt of the SHINE Emergency Plan and 

FSAR submitted with the operating license application.

The regulations in 10 CFR Part 50, Appendix E, Part II, Section C require that a PSAR provide 

sufficient information on protective measures to be taken within the site boundary to protect 

human health and safety in the event of an accident. Section H requires that a PSAR provide a 

preliminary analysis to identify the scope of potential radiological accidents. The acceptance 

criteria for information on recovery from NUREG-0849, Appendix 12.2 and NUREG-1537, Part 2 

include:

• The emergency plan specifies that recovery procedures will be written and approved as 

required.

• The emergency plan describes the procedures for promptly determining the actions 

necessary to reduce any ongoing releases of radioactive material or hazardous 
Conduct of Operations

12-29

chemicals incident to the processing of licensed material and to prevent further 

incidents.

• The emergency plan describes the provisions for promptly and effectively accomplishing 

required restoration plans.

The staff reviewed Section 9.0, “Recovery,” of the SHINE Preliminary Emergency Plan to 

ensure that the applicant considered the recovery phase of an accident, and in a RAI letter 

dated September 19, 2014 (Reference 14), submitted three RAIs related to this subsection. 

The applicant’s responses to RAI 12.7-29 through 12.7-31 are contained in Reference 20. 

In RAI 12.7-29, the staff requested that the applicant explain the bases for presenting a 

recovery condition that is different than that provided by the guidance. In response to RAI 

12.7-29, the applicant stated that it would clarify its characterization of recovery in the SHINE 

Emergency Plan submitted as part of the SHINE operating license application. The staff finds 

this to be an acceptable response for the issuance of a construction permit. The applicant 

initiated an IMR for this topic which the staff has identified as a regulatory commitment in 

Appendix A of this SER. Following receipt of the SHINE Emergency Plan and FSAR submitted 

for the SHINE operating license application, the staff will confirm that this issue has been 

resolved.

In RAI 12.7-30, the staff requested that the applicant identify the section within the SHINE 

Preliminary Emergency Plan that described the SHINE plans to restore the facility after an 

accident and to recover after an emergency. The staff also requested that the applicant 

describe the methods and responsibilities for assessing both the damage to the facility and the 

status of the facility’s capabilities to safely control radioactive material or hazardous chemicals. 

In response to RAI 12.7-30, the applicant stated they would describe in the SHINE Emergency 

Plan, provided as part of the SHINE operating license application, the methods and 

responsibilities for assessing the damage to the facility and status of the facility’s capabilities to 

safely control radioactive material or hazardous chemicals associated with the process. The 

staff finds this to be an acceptable response for the issuance of a construction permit. The 

applicant initiated an IMR for this topic which the staff has identified as a regulatory commitment 

in Appendix A of this SER. Following receipt of the SHINE Emergency Plan and FSAR, staff will 

confirm that this issue has been resolved.

In RAI 12.7-31, the staff requested that the applicant identify who will write and approve the 

recovery plans and procedures, what elements will be included, and to identify the location of 

the plans. In response to RAI 12.7-31, the applicant initiated an IMR to ensure an explanation is 

provided in the SHINE Emergency Plan submitted with the SHINE operating license application. 

The staff finds this to be an acceptable response for the issuance of a construction permit. This 

issue has been identified as a regulatory commitment in Appendix A of this SER. Following 

receipt of the SHINE Emergency Plan, the staff will confirm that this issue has been resolved.

Emergency planning is programmatic and the information in this subsection pertains to the 

operations of the SHINE facility. While specific details regarding recovery are not necessary for

the issuance of a construction permit, RAIs were necessary to confirm the adequacy of the 

scope of information provided in the preliminary emergency plan. In the responses to RAIs 

12.7-29, RAI 12.7-30, and RAI 12.7-31, the applicant has stated it would provide additional 

information regarding recovery in the SHINE Emergency Plan and FSAR submitted with the 

operating license application. Therefore, the staff has deferred a more detailed evaluation of 

this subsection until receipt of the SHINE Emergency Plan and FSAR supporting an operating 
Conduct of Operations

12-30

license application. The regulatory commitments for the emergency plan related to this subject 

are briefly summarized below:

• Section 9.0 of the SHINE Emergency Plan submitted as part of the operating license

application will be revised to clarify the characterization of recovery.

• The SHINE Emergency Plan submitted as part of the operating license application will 

describe the methods and responsibilities for assessing the damage to the SHINE facility 

and status of the facility’s capabilities to safely control radioactive material or hazardous 

chemicals associated with the process.

• The SHINE Emergency Plan submitted as part of the operating license application will 

describe who will write and who will approve recovery plans and procedures, what 

elements will be included, and where the plans will be kept.

Following receipt of the SHINE Emergency Plan and FSAR for the operating license, staff will 

confirm that these issues have been resolved.

The staff concludes that the information provided in the SHINE Preliminary Emergency Plan, 

Revision 0, Section 9.0, “Recovery,” is not necessary to meet regulatory requirements and 

acceptance criteria for the issuance of a construction permit. Further evaluation of this 

information will occur following the receipt of the SHINE Emergency Plan and FSAR submitted 

with the operating license application.

Appendix E, Part II, Section F of 10 CFR Part 50 describes the requirement for both employee 

training for those employees required to respond to an emergency and for nonemployees who 

might be called upon in the event of an emergency. The acceptance criteria for information on 

training from NUREG-0849 and the ISG for NUREG-1537, Part 2 include:

• The emergency plan should describe initial and periodic training for emergency 

response employees assigned functions for decision making and instructions, accident 

assessment, radiological monitoring and analysis teams, and for personnel involved in 

first aid and rescue, medical support, police, security, and ambulance and firefighting 

personnel.

• The emergency plan should describe the conduct of annual onsite emergency drills, 

include provisions for drill critiques including timely evaluation of observer comments 

and correction of identified deficiencies, and discuss the development of written 

scenarios for the conduct of annual action drills.

• The emergency plan should provide for a biennial review and update of the emergency 

plan and implementing procedures and agreements with offsite support organizations 

and agencies that includes review and approval by those responsible for emergency 

planning, incorporating modifications resulting from drill results or changes to the facility, 

and timely forwarding changes to the plan and implementing procedures, and 

agreements to the appropriate individuals, agencies, and supporting organizations.

• The emergency plan should describe the provisions to ensure the operational readiness 

of emergency communications and emergency health physics equipment including the 
Conduct of Operations

12-31

required maintenance and minimum calibration frequency, functional testing, and 

inventory of equipment and supplies.

The staff reviewed Section 10.0, “Maintaining Emergency Preparedness,” of the SHINE 

Preliminary Emergency Plan to evaluate the applicant’s maintenance of emergency 

preparedness and in a RAI letter dated September 19, 2014 (Reference 14), submitted three 

RAIs related to this subsection. The applicant’s responses to RAI 12.7-32 through 12.7-34 are 

contained in Reference 20.

In RAI 12.7-32, the staff requested that the applicant confirm that the list of specific training 

topics described in Subsection 10.1.2 of the SHINE Preliminary Emergency Plan, Revision 0, 

will include training targeted to the following personnel: 

• Those responsible for decision-making and transmitting emergency information and 

instructions.

• Those responsible for accident assessment, radiological monitoring and analysis teams.

• Those involved in first aid and rescue, medical support and police, security, ambulance 

and firefighting personnel. 

In response to RAI 12.7-32, the applicant stated they will update Section 10.1 of the SHINE 

Preliminary Emergency Plan to list training targeted to personnel responsible for decision 

making; for transmitting emergency information and instructions; for accident assessment; 

radiological monitoring and analysis teams; and personnel associated with first aid and rescue 

medical support, and police, security, ambulance, and firefighting personnel, in the SHINE 

Emergency Plan provided for the SHINE operating license application and FSAR. The applicant 

initiated an IMR to track the update to Section 10.1 of the emergency plan. The staff finds this 

to be an acceptable response for the issuance of a construction permit. This issue has been 

identified as a regulatory commitment in Appendix A of this SER. Following receipt of the 

SHINE Emergency Plan and FSAR, staff will confirm that this issue has been resolved.

In RAI 12.7-33, the staff requested that the applicant describe how emergency drills 

demonstrate personnel protection measures during fires, medical emergencies, mitigation 

activities, search and rescue, and other similar events, and to identify where this information can 

be found in the emergency plan. 

In response to RAI 12.7-33, the applicant stated that it will describe how emergency drills 

demonstrate personnel protection measures such as controlling and minimizing hazards to 

individuals during fires, medical emergencies, mitigation activities, and search and rescue in the 

SHINE Emergency Plan provided as part of the SHINE operating license application. The 

applicant initiated an IMR to ensure a description of how emergency drills demonstrate 

personnel protection measures is provided in the SHINE Emergency Plan submitted for the 

operating license application. The staff finds this to be an acceptable response for the issuance 

of a construction permit. This issue has been identified as a regulatory commitment in 

Appendix A of this SER. Following receipt of the SHINE Emergency Plan and FSAR, the staff 

will confirm that this issue has been resolved.

In RAI 12.7-34, the staff requested that the applicant provide information on the frequency, 

performance objectives, and plans for the emergency response training that will be provided to 

workers. The staff requested information on the general content and topics for training 
Conduct of Operations

12-32

programs to be given to both onsite and offsite emergency response personnel; and the 

administration of the training program including responsibility for training, positions requiring 

training, schedule, frequency, use of team training, hours required for training/retraining, 

required training for onsite personnel who are not member of the emergency planning staff, and 

special instruction and tours provided to offsite personnel who might be asked to respond in the 

event of an emergency. 

In response to RAI 12.7-34, the applicant stated it will provide information on the topics and 

general content of the training programs for both onsite and offsite personnel, provide details on 

the administration of the training program, on training on the use of protective equipment, on 

training for onsite personnel who are not members of the emergency staff, and on training for 

offsite personnel such as fire, police, and medical staff who might be called upon to assist in an 

emergency as part of the SHINE operating license application. The applicant initiated an IMR to 

ensure this information will be provided in the SHINE Emergency Plan submitted with the 

operating license application. The staff finds this to be an acceptable response for the issuance 

of a construction permit. This issue has been identified as a regulatory commitment in 

Appendix A of this SER. Following receipt of the SHINE Emergency Plan and FSAR, staff will 

confirm that this issue has been resolved.

Emergency planning is programmatic and the information in this subsection pertains to the 

operations of the SHINE facility. While specific details regarding maintenance of emergency 

preparedness are not necessary for the issuance of a construction permit, RAIs were necessary 

to confirm the adequacy of the scope of information provided in the preliminary emergency plan. 

In the responses to RAIs 12.7-32, RAI 12.7-33, and RAI 12.7-34, the applicant has stated it will 

provide additional information regarding maintaining emergency preparedness in the SHINE 

Emergency Plan and FSAR submitted with the operating license application. Therefore, the 

staff has deferred a more detailed evaluation of this subsection until receipt of the SHINE 

Emergency Plan and FSAR supporting an operating license. The regulatory commitments for 

the emergency plan and FSAR related to this subject are briefly summarized below:

• Section 10.1 of the SHINE Emergency Plan provided as part of the operating license

application will include training targeted to personnel responsible for decision making, 

accident assessment, and for radiological monitoring and analysis teams; and for 

personnel involved in first aid and rescue, medical support, and training for police, 

security, ambulance, and firefighting personnel.

• The SHINE Emergency Plan provided as part of the operating license application will 

demonstrate how emergency drills demonstrate personnel protection measures, 

including controlling and minimizing hazards to individuals during fires, medical 

emergencies, mitigation activities, search and rescue and other similar events.

• The SHINE Emergency Plan provided as part of the operating license application will 

provide the topics and general content of the training programs for both onsite and 

offsite emergency response personnel; the administration of the training program 

including responsibility for training, identification of positions requiring training, use of 

team and hours of training; training on the use of protective equipment such as 

respirators, protective clothing, monitoring devices, and other equipment used in 

emergency response; training for onsite staff who are not members of the emergency 

staff; and special instructions/tours the licensee would offer to non-licensee emergency 

personnel such as fire, police, and medical staff, and other non-licensee emergency 
Conduct of Operations

12-33

personnel who might be asked to provide emergency assistance to ensure they know 

the emergency plan, assigned duties, and effective response to an actual emergency. 

Following receipt of the SHINE Emergency Plan and FSAR for the operating license, staff will 

confirm that these issues have been resolved.

The staff concludes that the information provided in the SHINE Preliminary Emergency Plan, 

Rev. 0, Section 10.0, “Maintaining Emergency Preparedness,” is not necessary to meet 

regulatory requirements and acceptance criteria for the issuance of a construction permit. 

Further evaluation of this information will occur following the receipt of the SHINE Emergency 

Plan and FSAR submitted with the operating license application.

Security Planning

The staff evaluated the sufficiency of SHINE’s treatment of security planning, as described in 

SHINE PSAR Section 12.8, using the guidance and acceptance criteria from Section 12.8, 

“Security Planning,” in NUREG-1537, Part 1 and 2.

SHINE did not submit a security plan for its construction permit application. As stated in SHINE 

PSAR Section 12.8, “[t]he security plan will be developed using the guidance provided in 

Regulatory Guide 5.59, Revision 1 [Reference 56].”

A security plan is not required by regulation to be submitted for a construction permit 

application. Therefore, the staff considers SHINE’s commitment to develop its security plan 

using Regulatory Guide 5.59, Revision 1 to be acceptable. The staff will review SHINE’s 

security plan upon receipt as part of the SHINE FSAR.

Quality Assurance

The staff evaluated the sufficiency of the preliminary design of the SHINE QAPD, as described 

in Appendix C of SHINE PSAR Chapter 12, in part, by reviewing how the relevant requirements 

of 10 CFR 50.34(a)(7) were satisfied and by using the guidance and acceptance criteria from 

Section 12.9, “Quality Assurance,” of NUREG-1537, Parts 1 and 2, which provides a basis for 

the staff’s review of QA programs based on ANSI/ANS-15.8. The following is an evaluation of 

the SHINE QAPD as described in Appendix C of SHINE PSAR Chapter 12.

Section 12.9, “Quality Assurance,” of SHINE PSAR states that the “SHINE QA-1, Quality 

Assurance Program Description (QAPD), is based on ANSI/ANS 15.8-1995 [Reference 57] )

(ANSI/ANS, 1995), ‘Quality Assurance Program Requirements for Research Reactors,’ with 

guidance from Regulatory Guide 2.5, Revision 1.” However, it is not clear to what extent

ANSI/ANS 15.8-1995 has been applied to the development of the SHINE QAPD for the facility. 

Therefore, in RAI 12C.1-1 (Reference 14) the staff requested that the applicant confirm to what 

extent the SHINE QAPD implemented the guidance provided in ANSI/ANS-15.8-1995 across 

the facility, identifying and justifying any deviations from the guidance. In response to RAI 

12C.1-1 (Reference 20), the applicant stated, in part, that according to Regulatory Guide 2.5 

(Reference 58) ANSI/ANS-15.8-1995 provides an acceptable method of complying with the 

program requirements of 10 CFR 50.34, and was used by SHINE for developing the QAPD for 

the entire facility. The staff reviewed the SHINE response to RAI 12C.1-1 and determined that 

additional information was required to complete the review. Therefore, staff issued additional 

RAIs on January 6, 2015 (Reference 15).
Conduct of Operations

12-34

In RAI 12C.1-3, part (a) (Reference 15), the staff requested that the applicant further clarify its 

response to RAI 12C.1-1, by explaining whether SHINE had verified that ANSI/ANS-15.8-1995 

is sufficient for use in the development of the SHINE QAPD. In response to RAI 12C.1-3, part 

(a) (Reference 22) the applicant stated that SHINE had revised the Executive Summary of the 

SHINE QAPD to state that “SHINE had determined that ANSI/ANS 15.8-1995 is appropriate to 

use in the design of the facility even though the standard was written for research reactors.” 

The staff reviewed the SHINE response to RAI 12C.1-3, part (a), and determined that additional 

information was required to complete the review.

In RAI 12C.1-5 (Reference 16), the staff requested that the applicant further clarify its response 

to RAI 12C.1-3, part (a), by explaining if SHINE had determined whether ANSI/ANS 15.8-1995 

is sufficient for use in the development of the SHINE QAPD, which is to be applied in the 

design, fabrication, construction, and operation of the SHINE facility. 

The applicant’s response to RAI 12C.1-5 (Reference 24), indicated that SHINE had revised the 

Executive Summary of the SHINE QAPD to state that “SHINE has determined that 

ANSI/ANS-15.8-1995 is sufficient for use in the development of the SHINE QAPD, which is to 

be applied to the design, fabrication, construction, and operation of the SHINE facility.” 

The staff reviewed the SHINE response to RAI 12C.1-5 and verified that the revised Executive 

Summary of the SHINE QAPD was appropriately updated, based on the RAI response. The 

staff finds that the Executive Summary adequately describes the application of guidance 

provided in ANSI/ANS-15.8-1995 in the development of the SHINE QAPD. 

In RAI 12C.1-3, part (b) (Reference 15), the staff requested the applicant to clarify if the “SHINE 

QA-1” referred to in the first paragraph of Section 12.9 of the SHINE PSAR is, in fact, SHINE 

QAPD document number 2000-09-01. In response to RAI 12C.1-3 (Reference 22), the 

applicant stated that the naming convention of the QAPD had been changed from 

“SHINE-QA-1,” to document number 2000-09-01. SHINE updated Section 12.9 of the PSAR to 

refer to the current naming convention of the SHINE QAPD (Reference 32). The staff considers 

this RAI resolved. 

Section 1.1, “Scope,” of SHINE QAPD describes the administrative and engineered controls to 

be used during the design, construction, and operation of the facility.

In RAI 12C.5-1 (Reference 15), the staff requested that SHINE provide additional information 

regarding the quality assurance requirements that apply during the decommissioning phase. In 

response to RAI 12C.5-1 (Reference 22), the applicant stated that they had removed the term 

“decommissioning” from Sections 1.1 and 1.2 of the QAPD, and revised Section 5, 

“Decommissioning,” of the SHINE QAPD, to state that it will be updated at a later date. The 

SHINE commitment to update the QAPD at a later date, to address the requirements for 

decommissioning, is acceptable to the staff as this guidance is not necessary for the design and 

construction phases of the facility’s life.

The SHINE QA program, as described in Section 1.2, “Application,” of the SHINE QAPD, will be 

applied to SHINE activities, consistent with their importance to safety and reliability. Such 

activities will include, at a minimum, those related to irradiation unit safety and protection 

system, material processing safety, criticality safety, engineered safety features, and applicable 

radiation monitoring systems. SHINE will apply a graded approach to those items and activities 

that could affect the quality of safety-related SSCs and other components not designated as 

safety-related. SHINE activities affecting quality include siting, designing, purchasing, 
Conduct of Operations

12-35

fabricating, handling, shipping, receiving, storing, cleaning, erecting, installing, repairing, 

maintaining, modifying, inspecting, testing, and operating.

The staff determined that the description of the SHINE QA program application met the 

guidance provided in Section 12.9 of NUREG-1537, Parts 1 and 2, and ANSI/ANS-15.8-1995, 

and is therefore acceptable.

In Section 1.3, “Definitions,” the SHINE QAPD provided a list of key definitions used throughout 

the document. In RAI 12C.1-4 (Reference 15), the staff requested that the applicant clarify what 

definition of “safety-related” was provided in the SHINE stand-alone Administrative Procedure 

(AP) 2000-10-01, and where that definition was included in the SHINE QAPD. In addition, the 

staff requested additional information discussing why it was acceptable to maintain key 

definitions that were used in the SHINE QAPD, in a stand-alone administrative procedure. The 

applicant responded (Reference 22) that the following definition for safety-related SSCs was 

provided in the SHINE AP 2000-10-01 and revised Section 1.3 of the QAPD to include it, as 

follows:

Safety-related SSC – those SSCs that are relied upon to remain functional during 

normal conditions and during and following design basis events to assure:

1. The integrity of the primary system boundary;

2. The capability to shutdown the target solution vessel (TSV) and maintain the 

target solution in a safe shutdown (SSD) condition;

3. The capability to prevent or mitigate the consequences of accidents which 

could result in potential exposures comparable to the applicable guideline 

exposures set forth in 10 CFR 20;

4. That the potential for an inadvertent criticality accident is not credible;

5. That acute chemical exposures to an individual from licensed material or 

hazardous chemicals produced from licensed material could not lead to 

irreversible or other serious, long-lasting health effects to a worker or cause 

mild transient health effects to any individual located outside the owner 

controlled area; or

6. That an intake of 30 mg or greater of uranium in soluble form by any 

individual located outside the owner controlled area does not occur.

In the same response, the applicant also stated that Section 1.3 of the QAPD was revised to 

include all applicable ANSI/ANS-15.8-1995 (R2013) definitions. The response also stated that 

all definitions included in the SHINE QAPD are consistent with those provided in Section 1.3 of 

ANSI/ANS-15.8-1995 (R2013), with the following exceptions:

1. Modified the definition of “commissioning” by replacing the word “reactor” with 

“irradiation facility.”

2. The definition of “experiment” was not included in the SHINE QAPD.

3. Modified the definition of “management” by replacing the words “research 

reactor” with “SHINE.”

4. The definitions of “non-power reactor,” “research reactor,” and “test reactor” 

were not included in the SHINE QAPD.

5. The definition of “safety-related SSCs” was modified as described above.

The inclusion of applicable ANSI/ANS-15.8-1995 definitions in the revised SHINE QAPD 

addressed staff’s concern with maintaining key definitions in a stand-alone administrative 
Conduct of Operations

12-36

procedure, thus allowing for appropriate control of definitions that are important to establishing 

the QA program at SHINE. The modification of the definition of “commissioning” and 

“management” as described above is acceptable to the staff, as these changes are appropriate 

for the SHINE facility, which does not meet the definition of a “reactor.” The exclusion of the 

definition of experiment is acceptable, as the applicant has stated no experimentation will be 

necessary for the proposed operation of the facility. Further, the exclusion of definitions of 

“non-power reactor,” “research reactor,” and “test reactor” is also acceptable to the staff 

because these definitions do not apply to SHINE.

In RAI 12C.1-6, part (a) (Reference 16), the staff asked the applicant to clarify the basis for not 

including the definition of “experiment” in the QAPD, since conduct of experiments and use of 

experimental equipment are discussed in Sections 2.10 and 2.19 of the QAPD, respectively. 

The applicant’s response to RAI 12C.1-6, part (a) (Reference 24), indicated that SHINE did not 

plan on conducting experiments or utilizing experimental equipment, and the definition of 

“experiment” was, therefore, not included in the SHINE QAPD. Further, SHINE had revised 

Section 2.10 to remove the phrase “experiment fabrication” and had removed Section 2.19, 

Experimental Equipment, from the SHINE QAPD. The staff reviewed the SHINE response to 

RAI 12C.1-6, part (a) and verified that the SHINE QAPD was appropriately updated, based on 

the RAI response. The staff finds the SHINE response to be acceptable.

In RAI 12C.1-6, part (b) (Reference 16), the staff asked the applicant to provide additional 

information regarding the definitions of “audit,” as used in the SHINE QAPD Sections 2.7, 

“Control of Purchased Items and Services,” and 2.7.3, “Verification Activities,” and 

“assessment,” as used in Section 2.18, “Assessment,” and provide clarification as to the 

difference between the two definitions. The applicant’s response to RAI 12C.1-6, part (b) 

(Reference 24), stated that the SHINE definitions of “assessment” and “audit” are identical and 

SHINE used the terms interchangeably. SHINE further stated that they define both 

“assessment” and “audit” as “[a] planned and documented activity performed to determine by 

investigation, examination, or evaluation of objective evidence the adequacy of and compliance 

with established procedures, instructions, drawings, and other applicable documents, and the 

effectiveness of implementation.” The staff finds the applicant’s response to be acceptable.

In RAI 3.5-6, part (a) (Reference 16), the staff asked the applicant to provide a 

performance based definition for the fourth part (i.e., ‘[t]hat the potential for an inadvertent 

criticality accident is not credible”) of the six-part definition of the “safety-related SSCs,” or 

provide a discussion as to why it is not necessary. Further, in part (b) of the same RAI, the staff 

asked the applicant to discuss how the SHINE definition of “safety-related SSCs” aligns with the 

definition of “basic component” provided in 10 CFR 21.3. The applicant’s response to 

RAI 3.5-6, part (a) (Reference 24), stated that SHINE had revised the definition of 

“safety-related,” to read:

Safety-related SSCs: Those SSCs that are relied upon to remain functional

during normal conditions and during and following design basis events to assure:

1. The integrity of the primary system boundary;

2. The capability to shutdown the target solution vessel (TSV) and maintain 

the target solution in a safe shutdown (SSD) condition;

3. The capability to prevent or mitigate the consequences of accidents which 

could result in potential exposures comparable to the applicable guideline 

exposures set forth in 10 CFR 20;

4. That all nuclear processes are subcritical, including use of an approved 
Conduct of Operations

12-37

margin of criticality;

5. That acute chemical exposures to an individual from licensed material or 

hazardous chemicals produced from licensed material could not lead to 

irreversible or other serious, long-lasting health effects to a worker or

cause mild transient health effects to any individual located outside the 

owner controlled area; or

6. That an intake of 30 mg or greater of uranium in soluble form by any 

individual located outside the owner controlled area does not occur.

The staff verified that the SHINE QAPD was appropriately updated, based on the RAI response. 

The staff finds the SHINE response to be acceptable as it provides performance based criteria 

for acceptability.

Further, the SHINE response to RAI 3.5-6, part (b), stated that SHINE considers safety-related 

SSCs, as defined in part (a) of the RAI response, to be basic components, as defined 

in 10 CFR 21.3. The staff reviewed the SHINE response to RAI 3.5-6, part (b) and found that 

the SHINE proposed definition of “safety-related structures, systems, and components” and 

treatment of “basic component” are acceptable in providing a link to SHINE’s QAPD for Part 21 

requirements.

The SHINE QAPD is a top-level policy document that describes the requirements and tasks 

assigned to the various organizational elements, to achieve the SHINE objectives in assurance 

of quality. The SHINE overall philosophy regarding the achievement and assurance of quality is 

described in the QAPD, while implementing documents assign more specific responsibilities and 

duties for conducting activities within the scope of the QAPD.

Section 2.1, “Organization,” of the SHINE QAPD describes the SHINE organizational structure, 

functional responsibilities, levels of authority, and lines of communication for establishing, 

executing, and verifying implementation of activities within the scope of the QAPD.

The Quality Manager is responsible for the development and verification of implementation of 

the QAPD. The Quality Manager reports to the Chief Operating Officer (COO), an adequately 

authoritative level of management. The Quality Manager also has the ability and responsibility 

to report to Chief Executive Officer (CEO), who has overall responsibility for the SHINE QA 

program. The SHINE QAPD further establishes that the CEO delegates the necessary 

responsibility and authority, to ensure that quality is achieved and maintained by those who 

have been assigned responsibility for performing work, and that quality achievement is verified 

by persons not directly performing the work.

The QAPD establishes that the COO has access to work areas and encourages managers and 

employees to identify problems, initiate, recommend, or provide corrective action, and ensure 

corrective action implementation.

The SHINE QAPD establishes independence between the organizations responsible for 

performing a function and oversight activities performed by the quality organization (i.e., quality 

assurance and quality control).

The staff determined that the SHINE organizational controls are consistent with the guidance 

provided in Section 12.9 of NUREG-1537, Parts 1 and 2, and ANSI/ANS-15.8-1995, and 

therefore acceptable.
Conduct of Operations

12-38

The SHINE QAPD documents the requirements for establishing, implementing, and managing 

the QA program. The program implements a graded approach to quality, as described in 

Enclosure 2 of the SHINE QAPD. Quality Level (QL)-1 classification implements the full 

measure of the SHINE QAPD and will be applied to all safety-related SSCs. QL-2 classification 

will include the non-safety related activities performed by SHINE, and that are deemed 

necessary to ensure the manufacture and delivery of highly reliable products and services, to 

meet or exceed customer requirements and expectations.

All SHINE activities and tasks will be performed consistent with approved implementing 

procedures. SHINE procedures will be delineated, managed, and maintained by the Quality 

Manager, with support from SHINE staff.

The program provides for the appropriate and necessary indoctrination and training of personnel 

who perform activities affecting quality, to ensure that suitable proficiency is achieved and 

maintained. When required, qualification and selection of personnel will be conducted 

consistent with requirements established in applicable SHINE procedures. The scope of 

indoctrination will include administrative and technical objectives, as well as the requirements of 

applicable codes, standards, and the SHINE QAPD. Records of personnel training and 

qualification will be maintained.

In RAI 12C.E2-6, part (a) (Reference 16), the staff asked the applicant to clarify if the QL-1 

classification applies to safety-related activities, as well as safety-related SSCs. In addition, in 

part (b) of the same RAI, the staff asked SHINE to clarify how the definition of the QL-2 

classification is based on safety significance considerations. Further, in part (c) of the same 

RAI, the staff asked SHINE to explain if the QL-2 classification is intended to be applied only to 

selected non-safety related SSCs and activities. 

The SHINE response to RAI 12C.E2-6 (Reference 24), part (a) indicated that SHINE had 

revised the definition of the QL-1 classification to apply to safety-related activities, as well as 

safety-related SSCs. The staff reviewed the SHINE response to RAI 12C.E2-6, part (a) and 

verified that the revised definition of the QL-1 classification in Enclosure 2 of the SHINE QAPD 

was appropriately updated, based on the RAI response.

The SHINE response to RAI 12C.E2-6, part (b) indicated that SHINE had revised the definition 

of the QL-2 classification, to be based on safety significance considerations and the application 

of the full scope of the SHINE QAPD to the activities affecting quality. Further, the response 

stated that SHINE had added a new QL-3 classification, to be applied to non-safety related 

SSCs or activities that do not support or protect the safety function of safety-related SSCs or 

activities. The staff reviewed the SHINE response to RAI 12C.E2-6, part (b) and verified that 

the revised definition of the QL-2 classification and the new definition of the QL-3 classification 

were appropriately included in Enclosure 2 of the SHINE QAPD, based on the RAI response.

In response to RAI 12C.E2-6, part (c), SHINE stated that the QL-2 classification is intended to 

be applied only to selected non-safety related SSCs and activities. The staff reviewed the 

SHINE response to RAI 12C.E2-6, part (c), and found it to be acceptable.

The staff finds that the revised QL-1, QL-2, and QL-3 classifications adequately represent 

a graded approach to quality, as described in Section 2.2 and Enclosure 2 of the SHINE QAPD. 

The staff determined that the SHINE programmatic controls are consistent with the guidance 

provided in Section 12.9 of NUREG-1537, Parts 1 and 2, and ANSI/ANS-15.8-1995.
Conduct of Operations

12-39

In Section 2.3, “Design Control,” the SHINE QAPD establishes a design control process to 

control the design, design changes, and modifications subject to the provisions of the QAPD. 

The SHINE QAPD states that procedures will identify the process and include the provisions for 

the control of design documents, control of software, and implementation of required rules, 

regulations, codes, and standards.

As described below, the staff determined that the SHINE design controls are consistent with 

the guidance provided in Section 12.9 of NUREG-1537, Parts 1 and 2, and ANSI/ANS-15.8.

Section 2.3.1, “Design Requirements,” of the SHINE QAPD establishes that applicable design 

inputs, including design bases, performance requirements, regulatory requirements, codes, and 

standards, are to be identified and documented.

Section 2.3.2, “Design Process,” states that SHINE is responsible for identifying and controlling 

the design interfaces and will coordinate activities among participating organizations. The 

applicability of standardized or previously proven designs, with respect to meeting pertinent 

design inputs, will be verified for each application. Deviations from the established design 

inputs will be documented and controlled.

The design organization will ensure that final design is relatable to the design input by adequate 

documentation. Computer design programs used to develop any portion of the facility design or 

to analyze the design will be controlled. When a design program must be developed, the 

program will be controlled to ensure that it is fully documented and validated. When changes to 

previously validated computer programs are made, documented re-validation will be performed 

for the change and include appropriate benchmark testing.

Section 2.3.3, “Design Verification,” describes how the SHINE independent design reviews will 

be performed to verify the adequacy of design. Design verification will be performed by 

competent persons other than those who designed the item. Design verification will be 

completed prior to reliance upon the component, system, structure, or computer program to 

perform its function in operations. Qualification testing will be defined in formal test plans and 

will include appropriate acceptance criteria. Testing will demonstrate the adequacy of 

performance that simulates the most adverse design conditions. Test results will be 

documented and verified to have met the test requirements.

Section 2.3.4, “Design Documents and Records,” describes the SHINE process to ensure that 

design documents and records will provide evidence that the design and design verification 

processes were performed. Such documents and records will be collected, stored, and 

maintained for the life of the safety-related item.

Section 2.3.5, “Commercial Grade Items,” states that SHINE will have procedures in place, to 

provide for reviews and evaluations of commercial grade items, to be used in safety-related 

applications. If a commercial grade item is modified or selected by special inspection and/or 

testing to requirements that are more restrictive than the supplier’s published product 

description, the item will be identified in a different manner that is traceable to a documented 

description of the difference.

Section 2.3.6, “Change Control,” describes how modifications to the SHINE facility’s SSCs will 

be procedurally controlled. Design changes will be documented, justified, and subject to control 

measures commensurate with those applied to the original design. These measures will include 

assurance that the design analyses for SSCs or computer codes are still valid. When a 
Conduct of Operations

12-40

significant design change is necessary because of an incorrect design, the design organization 

will review and modify the design process and verification procedure, as necessary.

In Section 2.4, “Procurement Document Control,” the SHINE QAPD describes a process to 

ensure that procurement documents contain sufficient technical and quality requirements to 

ensure that the items and services satisfy the needs of SHINE. The SHINE QAPD stipulates 

that procurement documents at all procurement levels identify the documentation required to be 

submitted for information, review, or approval by SHINE. The procurement documents will 

require access to the supplier’s facility and records by designated individuals. Procurement 

documents will require the supplier to report non-conformances associated with the items or 

services being procured.

The staff determined that the SHINE procurement document controls are consistent with 

the guidance provided in Section 12.9 of NUREG-1537, Parts 1 and 2, and 

ANSI/ANS-15.8-1995, and therefore acceptable. 

Section 2.5, “Procedures, Instructions, and Drawings,” describes the SHINE measures to 

ensure that quality activities are based on documented instructions, procedures, or drawings, as 

appropriate. These documents will include or reference appropriate quantitative or qualitative 

acceptance criteria for determining that activities have been satisfactorily accomplished.

The staff determined that the SHINE controls for instructions, procedures, and drawings are 

consistent with the guidance provided in Section 12.9 of NUREG-1537, Parts 1 and 2, and 

ANSI/ANS-15.8-1995, and therefore acceptable.

Section 2.6, “Document Control,” describes the SHINE process to control the review, approval, 

and distribution of documents, including changes thereto, which prescribe activities affecting 

quality. The program and implementing procedures will establish the requirements for 

identification, review and approval, and distribution of documents. Major changes to controlled 

documents will be reviewed and approved by the same organizations that performed the review 

of the original issue.

The staff determined that the SHINE document controls are consistent with the guidance 

provided in Section 12.9 of NUREG-1537, Parts 1 and 2, and ANSI/ANS-15.8-1995, and 

therefore acceptable.

Section 2.7, “Control of Purchased Items and Services,” describes the SHINE measures to 

ensure that purchased items and services conform to procurement documents. These 

measures include supplier evaluation and selection, source surveillance and inspection, and 

audits and review of supplier documents, as applicable.

The staff determined that the SHINE controls for purchased items and services are consistent 

with the guidance provided in Section 12.9 of NUREG-1537, Parts 1 and 2, and 

ANSI/ANS-15.8-1995, and therefore acceptable.

As described, in Section 2.7.1, “Supplier Selection,” the SHINE QAPD requires that the 

selection of suppliers be based on evaluation of their capabilities to provide items or services 

consistent with the requirements of the procurement documents.

In Section 2.7.2, “Work Control,” the SHINE QAPD requires that measures be established to 

control the supplier’s performance. Controls may include review of test plans and supplier’s 
Conduct of Operations

12-41

submitted documents, source surveillance and inspection, and other technical and

administrative interfaces with the supplier, consistent with the procurement documents.

Section 2.7.3, “Verification Activities,” states that SHINE will require that suppliers verify and 

provide evidence of the quality of their products. SHINE will establish methods to control and 

approve supplier-generated documents. Based on the complexity of the product and 

importance to safety, SHINE will independently verify the quality of supplier’s product using 

source surveillances, inspections, audits, or review of supplier’s non-conformances, 

dispositions, waivers, and corrective actions.

Section 2.7.4, “Item or Service Acceptance,” describes the SHINE process to ensure that 

purchased items and services conform to procurement specifications. SHINE will use one or 

more of the following methods to accept and item or service: supplier Certificate of 

Conformance, source verification, receiving inspection, or post-installation test. Receiving 

inspection will include, as appropriate, verification by objective evidence such features as proper 

configuration, identification and cleanliness, shipping damage, and indication of fraud or 

counterfeit.

Section 2.8, “Identification and Control of Items,” describes the SHINE measures for item 

identification, traceability, and control purposes. The type of identification is established by 

specifications, codes, or standards. Items, including materials, will be identified by appropriate 

means. Where physical identification on the item is either impractical or insufficient, physical 

separation will be used. Items having a limited shelf and service life will be identified and 

controlled.

The staff determined that the SHINE controls for identification of items are consistent with

the guidance provided in Section 12.9 of NUREG-1537, Parts 1 and 2, and 

ANSI/ANS-15.8-1995.

Section 2.9, “Control of Special Processes,” describes the SHINE measures to ensure that 

approved special process procedures are used by qualified personnel, and consistent with

specified codes and standards, including acceptance criteria for the process. Special processes 

at SHINE will be controlled by instructions, procedures, drawings, checklists, travelers, or other 

appropriate means. Records for qualified personnel, processes, and equipment associated with 

special processes will be maintained, as appropriate.

The staff determined that the SHINE controls for special processes are consistent with the 

guidance provided in Section 12.9 of NUREG-1537, Parts 1 and 2, and ANSI/ANS-15.8-1995.

Section 2.10, “Inspections,” describes the SHINE inspection process to verify the quality and 

conformance of the item to specified requirements. The inspection process will be applicable to 

procurement, construction, modification, maintenance, and experiment fabrication. Inspections 

will be performed by persons other than those who performed the work being inspected, but 

may be from the same organization. Measuring and Test Equipment (M&TE) used to perform 

inspections will be identified in inspection documentation, for traceability of inspection results. 

Only items that have passed the required inspections and tests will be used, installed, or 

operated. Inspection results will be documented. Acceptance of items will be documented and 

approved by authorized personnel. Verification of conformance of work activities for the 

purpose of acceptance will be performed by qualified personnel.
Conduct of Operations

12-42

SHINE will determine the need for formal training and conduct such training, as required, to 

qualify inspection and test personnel. SHINE will provide on-the-job training, as appropriate. 

Records of inspection personnel’s qualification will be established and maintained by SHINE or 

the appropriate contractor.

The staff determined that the SHINE controls for inspection are consistent with the guidance 

provided in Section 12.9 of NUREG-1537, Parts 1 and 2, and ANSI/ANS-15.8-1995, and 

therefore acceptable.

Section 2.11, “Test Control,” describes the SHINE measures to demonstrate that SSCs will 

perform satisfactorily in service. Test results will be documented and evaluated by a 

responsible authority to ensure that test requirements have been satisfied. Computer programs 

to be used for operational control will be tested consistent with an approved verification and 

validation plan and will demonstrate required performance over the range of operation of the 

controlled function or process.

The staff determined that the SHINE controls for testing are consistent with the guidance 

provided in Section 12.9 of NUREG-1537, Parts 1 and 2, and ANSI/ANS-15.8-1995, and 

therefore acceptable.

Section 2.12, “Control of Measuring and Test Equipment,” describes the SHINE measures to 

ensure that tools, gauges, instruments, and other M&TE used for activities affecting quality are 

controlled, calibrated, or adjusted at specified periods, to maintain accuracy within specified 

limits.

Out-of-calibration devices will be tagged and segregated, until calibration has been restored. 

Records of calibration traceable to individual M&TE will be maintained. Calibration and control 

measures will not be required when normal commercial equipment provides adequate accuracy.

The staff determined that the SHINE controls for M&TE are consistent with the guidance 

provided in Section 12.9 of NUREG-1537, Parts 1 and 2, and ANSI/ANS-15.8-1995.

In Section 2.13, “Handling, Storage, and Shipping,” the SHINE QAPD requires that handling, 

storage, and shipping of items be performed consistent with work and inspection instructions, 

drawings, specifications, shipping instructions, or other pertinent documents or procedures.

The staff determined that the SHINE controls for handling, storage, and shipping are consistent 

with the guidance provided in Section 12.9 of NUREG-1537, Parts 1 and 2, and 

ANSI/ANS-15.8-1995 and therefore acceptable.

In Section 2.14, “Inspection, Test, and Operating Status,” the SHINE QAPD requires that the 

status of inspection and test activities be identified on the items or in documents traceable to the 

items. Identification of inspection and test status will ensure that required inspection and test 

were performed and prevent inadvertent installation or operation of items that have not passed 

the required inspections or tests.

The staff determined that the SHINE controls for inspection, test, and operating status are 

consistent with the guidance provided in Section 12.9 of NUREG-1537, Parts 1 and 2, and 

ANSI/ANS-15.8-1995 and therefore acceptable.
Conduct of Operations

12-43

In Section 2.15, “Control of Nonconforming Items and Services,” the SHINE QAPD described 

the necessary measures to control nonconforming items, to prevent their inadvertent use or 

installation. These controls include measures for identification, documentation, evaluation, 

segregation (as appropriate), and disposition of nonconforming items. Recommended 

dispositions, such as “use-as-is,” “reject,” “repair,” or “rework,” will be identified, documented, 

and approved.

SHINE will document the technical justification for the acceptability of a nonconforming item 

dispositioned as “repair” or “use-as-is.” Non-conformances to design requirements of items 

dispositioned as “repair” or “use-as-is” will be subject to design control measures commensurate 

with those applied to the original design. Nonconforming items dispositioned as “repair” or 

“rework” will be re-examined consistent with applicable procedures and appropriate acceptance 

criteria.

The staff determined that the SHINE controls for nonconforming items and services are 

consistent with the guidance provided in Section 12.9 of NUREG-1537, Parts 1 and 2, and 

ANSI/ANS-15.8-1995 and therefore acceptable.

In Section 2.16, “Corrective Actions,” the SHINE QAPD requires that conditions adverse to 

quality be identified promptly and corrected as soon as practical. The corrective actions will be 

consistent with the design requirements, unless those requirements were faulty.

In the case of a significant condition adverse to quality, the cause of the condition will be 

investigated and corrective action to prevent recurrence will be taken.

The staff determined that the SHINE controls for corrective action are consistent with 

the guidance provided in Section 12.9 of NUREG-1537, Parts 1 and 2, and 

ANSI/ANS-15.8-1995 and therefore acceptable.

In Section 2.17, “Quality Records,” the SHINE QAPD describes the necessary measures to 

ensure that, at minimum, sufficient records of the following activities be maintained and 

appropriately stored: inspection and test results, results of quality assurance reviews, quality 

assurance procedure, and engineering reviews and analyses for design or changes and 

modifications. The SHINE records system or systems will be defined, implemented, and 

enforced consistent with written procedures, instructions, or other documentation.

Some records will be maintained by or for the plant owner for the life of the item while it is 

installed in the plant or stored for future use. Such records will be classified consistent with

applicable documented classification criteria. Other records will be retained for a shorter period, 

as determined by SHINE.

Records will be stored in a location that provides damage prevention from moisture, 

temperature, and pestilence. Provisions will be specified for special processed records such as 

radiographs, photographs, negatives, microfilm, and magnetic media, to prevent damage. 

SHINE requires that records that be maintained by a supplier be accessible to SHINE.

The staff determined that the SHINE controls for quality records are consistent with the 

guidance provided in Section 12.9 of NUREG-1537, Parts 1 and 2, and ANSI/ANS-15.8-1995, 

and therefore acceptable.
Conduct of Operations

12-44

In Section 2.18, “Assessments,” the SHINE QAPD describes the necessary measures for 

conducting periodic assessments of quality-affecting activities during design, construction, 

modification, and operations, to evaluate the effectiveness of the quality program 

implementation.

Assessments will be performed consistent with written procedures or checklists. Assessment 

results will be documented and reviewed by the management personnel responsible for the 

area assessed. Management of the assessed organization will investigate adverse findings and 

schedule corrective actions. The adequacy of the responses will be evaluated by the assessing 

organization. Assessment records will include plans, reports, written replies, and records of 

completion of corrective actions.

SHINE requires that personnel conducting assessments have the requisite training and 

experience.

The staff determined that the SHINE controls for assessments are consistent with the guidance 

provided in Section 12.9 of NUREG-1537, Parts 1 and 2, and ANSI/ANS-15.8-1995 and 

therefore acceptable.

Section 3, “Facility Operations,” of the SHINE QAPD describes the elements of a quality 

assurance program for conduct of operation at the SHINE facility. The SHINE QAPD also

establishes that some requirements of the QA program for operations may be found in other 

documents, such as the Training Program, Emergency Plan, Security Plan, Technical 

Specifications, and the Radiation Protection Program, and would not be duplicated in the quality 

assurance program.

The information provided in Section 3, “Facility Operations,” of the SHINE QAPD, including its 

subsections, pertains to the operations of the SHINE facility, and specific details are not 

necessary for the issuance of a construction permit. Therefore, the staff has deferred a more 

detailed evaluation of this section until the receipt of an FSAR supporting an operating license 

application.

Section 5, “Decommissioning,” of the SHINE QAPD, pertains to decommissioning of the SHINE 

facility, and is not necessary for the issuance of a construction permit. SHINE stated in Section 

5 of the SHINE QAPD that this section would be updated at a later date. Therefore, the staff 

has deferred the review of this section until the receipt of an FSAR supporting an operating 

license application. Following receipt of the SHINE FSAR, staff will confirm that this issue has 

been resolved.

On the basis of its review, the staff has determined the information to be included in SHINE 

FSAR Section 12.9, “Quality Assurance,” is sufficient and meet the applicable regulatory 

requirements and guidance for the issuance of a construction permit in accordance with 

10 CFR 50.35. 

Operator Training and Requalification

The staff evaluated the sufficiency of the SHINE operator training and requalification program, 

as described in SHINE PSAR Section 12.10, using the guidance and acceptance criteria from 

Section 12.10, “Operator Training and Requalification,” in NUREG-1537, Part 1 and 2.
Conduct of Operations

12-45

As stated in SHINE PSAR Section 12.10, “[t]he SHINE facility operator training and 

requalification program will be described in the FSAR.”

Per 10 CFR 50.34(b), the applicant does not need to address operator training considerations 

until the submission of its FSAR. As such, the staff has determined that it is not necessary for 

SHINE to submit an operator training and requalification program for its construction permit 

application. SHINE’s operator training and requalification will be reviewed and evaluated when 

SHINE submits an FSAR for an operating license application.

Therefore, the staff finds that the review of SHINE’s operator training and requalification 

program, as described in SHINE PSAR 12.10, can reasonably be left for later consideration in 

the evaluation of the SHINE FSAR.

Startup Plan

The staff evaluated the sufficiency of the preliminary design of the SHINE startup plan, as 

described in SHINE PSAR Section 12.11, using the guidance and acceptance criteria from 

Section 12.11, “Startup Plan,” in NUREG-1537, Part 1 and 2.

As stated in SHINE PSAR Section 12.11, “The startup plan will be described in the FSAR.”

The staff has considered this statement in the PSAR and determined, using the guidance in 

NUREG-1537, that this information is specific to the operation of the SHINE facility, and as 

such, is not necessary for the issuance of a construction permit.

Therefore, the staff finds deferring its review of the startup plan, as described in SHINE PSAR 

Section 12.11, can reasonably be left for later consideration in the evaluation of the SHINE 

FSAR.

Environmental Reports

Section 12.4.12, “Environmental Reports,” has been superseded by Chapter 19, “Environmental 

Review.” 

SHINE’s environmental report was provided as Chapter 19 of the SHINE PSAR.

Results of the staff’s review of the environmental report is provided in the environmental impact 

statement contained in NUREG-2183, “Environmental Impact Statement for the Construction 

Permit for the SHINE Medical Radioisotope Production.”

Material Control and Accounting Plan

The staff evaluated the sufficiency of the preliminary design of the SHINE material control and 

accounting (MC&A) plan, as described in SHINE PSAR Section 12.13, using the guidance and 

acceptance criteria from Section 12.13, “Material Control and Accounting Plan,” in the ISG 

Augmenting NUREG-1537, Parts 1 and 2.

As stated in SHINE PSAR Section 12.13, “[t]he material, control, and accountability program will 

be provided in the FSAR.”
Conduct of Operations

12-46

The staff has considered the statement in the PSAR and determined that since SHINE has not 

requested a license for special nuclear material during construction, a material control and

accounting plan is not necessary at this time. A material control and accounting plan will be 

necessary when SHINE applies for a license to possess special nuclear material.

Therefore, the staff finds deferring its review of SHINE’s material control and accounting plan, 

as described in SHINE PSAR 12.13, can reasonably be left for later consideration in the 

evaluation of the SHINE FSAR or if SHINE applies for a license to possess special nuclear 

material.

Summary and Conclusions

SHINE PSAR Chapter 12 describes the conduct of operations for the IF and RPF, therefore, the 

technical evaluation of the SHINE conduct of operations, described in SHINE PSAR, Chapter 

12, applies to both the IUs and RPF.

The staff evaluated the descriptions and discussions of the SHINE organization, including 

probable subjects of technical specifications, as described in Chapter 12 of the SHINE PSAR 

and supplemented by the applicant’s responses to RAIs, and finds that the preliminary design of 

the SHINE organization meets the applicable guidelines of ISG Augmenting NUREG-1537, 

Part 2 and NUREG-1537, Part 2, as follows:

• The staff finds the information related to the review of SHINE PSAR Section 12.2, along 

with the responses to RAIs, is sufficient and meets the applicable regulatory 

requirements and guidance for the issuance of a construction permit. SHINE stated it 

would provide the remaining requested information in the SHINE FSAR. Therefore, 

further evaluation of this section will occur following the receipt of the SHINE FSAR, 

supporting an operating license application.

• The staff finds the information related to the review of SHINE PSAR Section 12.3, along 

with the responses to an RAI, is sufficient and meets the applicable regulatory 

requirements and guidance for the issuance of a construction permit. SHINE stated it 

would provide the remaining requested information in the SHINE FSAR. Therefore, 

further evaluation of this section will occur following the receipt of the SHINE FSAR, 

supporting an operating license application.

• The staff finds the information on required actions, reports, and records may reasonably 

be left for later consideration in the FSAR.

• The staff identified commitments related to the review of SHINE PSAR Section 12.7, 

“Emergency Planning,” and the SHINE Preliminary Emergency Plan. The staff noted 

that the information in this section pertains more specifically to the operations of the 

SHINE facility, and the commitment items are not necessary to be resolved for the 

issuance of a construction permit. SHINE stated that it would provide the requested 

information in the SHINE Emergency Plan and FSAR supporting an operating license 

application. The staff finds that the information in this section meets the regulatory 

requirements and acceptance criteria for the issuance of a construction permit. Further 

evaluation of this section will occur following the receipt of the SHINE FSAR and 

Emergency Plan supporting an operating license application. 
Conduct of Operations

12-47

• The staff finds the information on security planning may reasonably be left for later 

consideration in the FSAR.

• The staff finds the information to be included in SHINE PSAR Section 12.9, “Quality 

Assurance,” is sufficient and meet the applicable regulatory requirements and guidance 

for the issuance of a construction permit, however, due to limited information provided in 

the SHINE PSAR regarding the SHINE quality assurance program requirements during 

operations and decommissioning, further evaluation of the SHINE QAPD will occur 

following the receipt of the SHINE FSAR.

• The staff finds the information on the operator training and requalification program, 

startup plan, and MC&A plan may reasonably be left for later consideration in the FSAR.

On the basis of these findings, the staff has made the following conclusions for of the issuance 

of a construction permit in accordance with 10 CFR 50.35 and 50.40:

(1) There is reasonable assurance that, taking into consideration the site criteria contained 

in 10 CFR Part 100, the proposed facility can be constructed and operated at the 

proposed location without undue risk to the health and safety of the public.

(2) There is reasonable assurance: (i) that the construction of the SHINE facility will not 

endanger the health and safety of the public, and (ii) that construction activities can be 

conducted in compliance with the Commission’s regulations.

(3) The issuance of a permit for the construction of the facility would not be inimical to the 

common defense and security or to the health and safety of the public.

13-1

ACCIDENT ANALYSES

The accident analysis shows that the health and safety of the public and workers are protected, 

potential radiological and non-radiological consequences have been considered in the event of 

malfunctions, and the facility is capable of accommodating disturbances in the functioning of 

structures, systems, and components. Additionally, the accident analysis demonstrates that the 

facility design features, safety limits, limiting safety system settings, and limiting conditions for 

operation have been selected to ensure that no credible accident could lead to unacceptable 

radiological consequences to people or the environment.

The accidents analyzed range from such anticipated events as a loss of normal electrical power 

to a postulated fission-product release with radiological consequences that exceed those of any 

accident considered to be credible. This limiting accident is named the maximum hypothetical 

accident (MHA). Because the MHA is not expected to occur, the scenario need not be entirely 

credible. The initiating event and the scenario details need not be analyzed, but the potential 

consequences should be analyzed and evaluated.

The accident analysis establishes safety limits for facility operations and provides a technical 

basis for control of those limits through technical specifications.

This chapter of the SHINE construction permit safety evaluation report (SER) describes the 

review and evaluation of the U.S. Nuclear Regulatory Commission (NRC) staff (the staff) of the 

preliminary accident analysis of the SHINE irradiation facility (IF) and radioisotope production 

facility (RPF), as presented in Chapter 13, “Accident Analysis,” of the SHINE Preliminary Safety 

Analysis Report (PSAR), as supplemented by the applicant’s responses to requests for 

additional information (RAIs). Together the IF and RPF constitute the SHINE facility.

13a Irradiation Facility Accident Analyses

Section 13a, “Irradiation Facility Accident Analysis,” provides an evaluation of the preliminary 

accident analysis of SHINE’s IF as presented in PSAR Section 13a2, “Irradiation Facility 

Accident Analysis,” within which, SHINE describes accident-initiating events and scenarios, as 

well as the accident analysis and determination of consequences.

13a.1 Areas of Review

The staff reviewed SHINE PSAR Section 13a2 against the applicable regulatory requirements 

described in NRC regulatory guidance and standards to assess the sufficiency of the 

preliminary accident analysis. As part of this review, the staff evaluated descriptions and 

discussions of SHINE’s accident analysis, with special attention to design and operating 

characteristics, unusual or novel design features, and principal safety considerations. The 

preliminary accident analysis was evaluated to ensure the sufficiency of principal design criteria; 

design bases; and information relative to materials of construction, general arrangement, and 

approximate dimensions sufficient to provide reasonable assurance that the final design will 

conform to the design basis. In addition, the staff reviewed SHINE’s identification and 

justification for the selection of those variables, conditions, or other items that are determined to 

be probable subjects of technical specifications for the facility, with special attention given to 

those items that may significantly influence the final design. Structures, systems, and 

components (SSCs) were also evaluated to ensure that they would adequately provide for the 
Accident Analysis

13-2

prevention of accidents and the mitigation of consequences of accidents. The staff considered 

the preliminary analysis and evaluation of the design and performance of the SSCs of the 

SHINE facility, including those SSCs shared by both the IF and RPF, with the objective of 

assessing the risk to public health and safety resulting from operation of the facility.

Areas of review for this section included accident-initiating events and scenarios, as well as the 

accident analysis and determination of consequences. Within these areas of review, the staff 

assessed the maximum hypothetical accident, target solution release into the irradiation unit 

(IU) cell, excess reactivity insertion accident, inadvertent criticality events, reduction in cooling, 

mishandling or malfunction of target solution, loss of off-site power, external events, mishandling 

or malfunction of equipment affecting the primary system boundary, large un-damped power 

oscillations, detonation and deflagration in the primary system boundary, unintended exothermic 

chemical reactions other than detonation, primary system boundary system interaction events, 

and facility-specific events.

13a.2 Summary of Application

The SHINE IF design has features that are important for understanding the accident analysis. 

The SHINE IF contains eight Irradiation Units (IUs). Each IU contains a neutron driver, a Target 

Solution Vessel (TSV), a TSV dump tank, and a TSV off-gas system (TOGS) which are all 

surrounded by thick concrete shielding. The TSV and TSV dump tank sit in the light water pool. 

The light water pool is a large pool of water that is cooled by the light water pool system 

(LWPS). The LWPS removes heat from the neutron driver accelerator target chamber, the 

neutron multiplier, and any other heat load on the pool such as radiation energy deposition. The 

primary closed loop cooling system (PCLS) circulates water past heat transfer surfaces to cool 

the TSV. The TOGS is in a concrete shielded cell. The TOGS circulates sweep gas through 

the gas space of the TSV. It recombines hydrogen and oxygen generated in the TSV by 

radiolysis and condenses water vapor from the TSV. The atmosphere in the TOGS shielded 

cell and above the light water pool is connected by ducts to the radiologically controlled area 

(RCA) ventilation Zone 1 (RVZ1). These ducts are a path for airborne radiation to escape from 

the IU and move into the ventilation system should a release from the TOGS occur. There are 

isolation dampers on the ducts that close in the event of a high radiation signal. There are also 

penetrations in the IUs that can be leakage paths for airborne radioactivity in the IU atmosphere 

to the RCA where the IUs are located. The building atmosphere in RVZ1 is vented to the 

outside through high-efficiency particulate air (HEPA) and charcoal filters.

SHINE PSAR Section 13a2 describes accident-initiating events and scenarios, as well as the 

accident analysis and determination of consequences for the SHINE IF. The application 

provides details on event categories covering credible accidents related to the IF, including the 

target solution and the accelerator; the maximum hypothetical accident intended to bound all 

credible accidents; limiting accidents; target solution release into the irradiation unit (IU) cell; 

excess reactivity insertion accident; inadvertent criticality events; reduction in cooling; 

mishandling or malfunction of target solution; loss of off-site power; external events; mishandling 

or malfunction of equipment affecting the primary system boundary; large un-damped power 

oscillations; detonation and deflagration in the primary system boundary; unintended exothermic 

chemical reactions other than detonation; primary system boundary system interaction events; 

and facility-specific events.
Accident Analyses

13-3

13a.3 Regulatory Basis and Acceptance Criteria

The staff reviewed SHINE PSAR Section 13a2 against applicable regulatory requirements, 

regulatory guidance, and standards, to assess the sufficiency of the preliminary accident 

analysis for the issuance of a construction permit. In accordance with paragraph (a) of Title 10 

of the Code of Federal Regulations (10 CFR) 50.35, “Issuance of Construction Permits,” a 

construction permit authorizing SHINE to proceed with construction may be issued once the 

following findings have been made:

(1) SHINE has described the proposed design of the facility, including, but not limited to, 

the principal architectural and engineering criteria for the design, and has identified the 

major features or components incorporated therein for the protection of the health and 

safety of the public. 

(2) Such further technical or design information as may be required to complete the safety 

analysis, and which can reasonably be left for later consideration, will be supplied in 

the final safety analysis report (FSAR).

(3) Safety features or components, if any, which require research and development have 

been described by SHINE and a research and development program will be conducted 

that is reasonably designed to resolve any safety questions associated with such 

features or components. 

(4) On the basis of the foregoing, there is reasonable assurance that: (i) such safety 

questions will be satisfactorily resolved at or before the latest date stated in the 

application for completion of construction of the proposed facility, and (ii) taking into 

consideration the site criteria contained in 10 CFR Part 100, the proposed facility can 

be constructed and operated at the proposed location without undue risk to the health 

and safety of the public.

With respect to the last of these findings, the staff notes that the requirements of 

10 CFR Part 100 are specific to nuclear power reactors, and therefore not applicable to the 

SHINE facility. However, the staff evaluated SHINE’s site specific conditions using site criteria 

similar to 10 CFR Part 100, by using the guidance in NUREG-1537. The staff’s review 

evaluated the geography and demography of the site; nearby industrial, transportation, and 

military facilities; site meteorology; site hydrology; and site geology, seismology, and 

geotechnical engineering to ensure that issuance of the construction permit will not be inimical 

to public health and safety.

The staff’s evaluation of the preliminary accident analysis does not constitute approval of the 

safety of any design feature or specification. Such approval will be made following the 

evaluation of the final design of the SHINE facility as described in the FSAR as part of SHINE’s 

operating license application.

13a.3.1 Applicable Regulatory Requirements

The applicable regulatory requirements for the evaluation of SHINE’s preliminary accident 

analysis are as follows:

• 10 CFR 50.34, “Contents of applications; technical information,” paragraph (a), 

“Preliminary safety analysis report.”
Accident Analysis

13-4

• 10 CFR 50.40, “Common Standards.”

• 10 CFR 20.1201, “Occupational dose limits for adults.”

• 10 CFR 20.1301, “Dose limits for individual members of the public.”

13a.3.2 Regulatory Guidance and Acceptance Criteria

In applying guidance and acceptance criteria, the staff used its judgment as to which 

acceptance criteria were relevant to SHINE’s proposed facility, as much of this guidance was 

originally developed for nuclear reactors. Given the similarities in SHINE’s proposed facility and 

non-power research reactors, the staff used established guidance documents and the 

Commission’s regulations to determine the acceptance criteria for demonstrating compliance 

with 10 CFR regulatory requirements. For example, the staff used: 

• NUREG-1537, Part 1, “Guidelines for Preparing and Reviewing Applications for the 

Licensing of Non-Power Reactors, Format and Content,” issued February 1996 

(Reference 4).

• 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 (Reference 5).

• “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 (Reference 6).

• “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 (Reference 7).

As stated in the ISG Augmenting NUREG-1537, the staff determined that certain guidance 

originally developed for heterogeneous non-power research and test reactors is applicable to 

aqueous homogenous facilities and production facilities. SHINE used this guidance to inform 

the design of its facility and prepare its PSAR. The staff’s use of reactor-based guidance in its 

evaluation of the SHINE PSAR is consistent with the ISG Augmenting NUREG-1537.

As appropriate, additional guidance (e.g., NRC regulatory guides, Institute of Electrical and 

Electronics Engineers (IEEE) standards, American National Standards Institute/American 

Nuclear Society (ANSI/ANS) standards) has been used in the staff’s review of SHINE’s PSAR. 

The use of additional guidance is based on the technical judgment of the reviewer, as well as 

references in NUREG-1537, Parts 1 and 2; the ISG Augmenting NUREG-1537, Parts 1 and 2; 

and the SHINE PSAR. Additional guidance documents used to evaluate SHINE’s PSAR are 

provided as references in Appendix B of this SER.
Accident Analyses

13-5

13a.4 Review Procedures, Technical Evaluation, and Evaluation Findings

The staff performed an evaluation of the technical information presented in SHINE PSAR 

Section 13a2, as supplemented by the applicant’s responses to RAIs, to assess the sufficiency 

of the preliminary design and performance of SHINE’s accident analysis in the IF for the 

issuance of a construction permit, in accordance with 10 CFR 50.35(a). The sufficiency of the 

SHINE preliminary accident analysis is determined by whether the design and performance 

meet applicable regulatory requirements, guidance, and acceptance criteria, as discussed in 

Section 13a.3, “Regulatory Basis and Acceptance Criteria,” of this SER. While the technical 

evaluation of preliminary accident analysis provided in this section is specific to the SHINE IF, 

the staff’s review considers the interface of accident scenarios between the IF and RPF as part 

of a comprehensive technical evaluation. The results of this technical evaluation are 

summarized in SER Section 13a.5, “Summary and Conclusions.”

For the purposes of issuing a construction permit, the preliminary accident analysis may be 

adequately described at a conceptual level. The staff evaluated the sufficiency of the 

preliminary accident analysis based on the applicant’s design methodology and ability to provide 

reasonable assurance that the final design will conform to the design bases with adequate 

margin for safety. As such, the staff’s evaluation of the preliminary accident analysis does not 

constitute approval of the safety of any design feature or specification. Such approval will be 

made following the evaluation of the final design of the SHINE facility, as described in the 

FSAR, as part of SHINE’s operating license application.

For SER Sections 13a.4.1 through 13a.4.14, the staff evaluated the sufficiency of the 

preliminary identification, analysis, and determination of consequences of accident-initiating 

events and scenarios, as described in SHINE PSAR Sections 13a2.1 and 13a2.2, in part, by 

reviewing the maximum hypothetical accident, inadvertent criticality events, reduction in cooling, 

mishandling or malfunction of target solution, loss of off-site power, external events, mishandling 

or malfunction of equipment affecting the primary system boundary, large undamped power 

oscillations, detonation and deflagration in the primary system boundary, unintended exothermic 

chemical reactions other than detonation, primary system boundary system interaction events, 

and facility-specific events, using the guidance and acceptance criteria from Sections 13a2, 

“Aqueous Homogeneous Reactor Accident Analyses,” and 13a2.1, “Accident-Initiating Events 

and Scenarios,” of the ISG Augmenting NUREG-1537, Parts 1 and 2.

For SER Sections 13a.4.1 through 13a.4.14, consistent with the review procedures in the ISG 

Augmenting NUREG-1537, Part 2, Sections 13a2 and 13a2.1, the staff followed the sequence 

of events in each accident scenario from initiation to stabilization. The staff evaluated credible 

accidents; instruments, controls and automatic protective systems assumed to be operating 

normally before an initiating event; the identification of single malfunctions; the discussion of 

sequence of events and components and systems damaged during the accident scenario; 

mathematical models and analytical methods employed; radiation source term; and that 

potential radiation consequences to the facility staff and public were presented and compared 

with acceptable limits. Additionally, the staff assessed whether the integrity of the primary 

system boundary would be maintained under credible accidents analyzed, determined whether 

all analyzed credible accidents have been categorized, confirmed that the applicant analyzed 

potential power instabilities, and confirmed that loss of normal electrical power and consequent 

reduction in cooling would not challenge the primary system boundary. Also, as described in 

SHINE PSAR Sections 13a2.1.12 and 13a2.2.12, “Facility-Specific Events,” the applicant 

evaluated the SHINE facility for initiating events and possible design basis accidents that are 

possible because of the unique design features of the facility as specified by NUREG-1537 and 
Accident Analysis

13-6

the ISG. The applicant identified and analyzed possible events and accidents that fall under this 

category. The applicant analyzed the consequences of the facility-specific initiating events and 

accidents proposed in the accident-initiating events section of the PSAR. These events are 

presented in Sections 13a.4.12 – 13a.4.14 in this SER.

13a.4.1 Maximum Hypothetical Accident

As described in SHINE PSAR Sections 13a2.1.1, “Maximum Hypothetical Accident,” and 

13a2.2.1, “Target Solution Release into the IU Cell,” SHINE considered an MHA for the IF as 

well as the RPF. While an evaluation of the MHA for the IF is provided below, the RPF 

postulated MHA, as described in SHINE PSAR 13b.2.1, “Maximum Hypothetical Accident in the 

RPF,” provides the bounding consequences to the public and is therefore considered the MHA 

for the SHINE facility. An evaluation of the RPF postulated MHA is provided in SER section 

13b.4.3 of this SER.

SHINE postulated a non-specific large rupture of the TSV or dump tank for a single IU as the 

MHA for the Irradiation Facility (IF). Hypothetical causes for the rupture include corrosion, 

overpressure, maintenance or operational errors. However, as stated in SHINE PSAR, Section 

13a2.1.1.1, “Initial Conditions and Assumptions,” “[b]ecause the SHINE facility is being 

designed to withstand external events ... scenarios that involve multiple IUs are not analyzed 

further.” However, the staff noted that a group of similar systems or components failing

together, as a result of a single external event, is still considered a single failure. Therefore, in 

RAI 13a2.1-1 (Reference 14), the staff requested that SHINE provide the basis for rejecting 

events that could affect multiple irradiation units. The ISG Augmenting NUREG-1537, Part 2, 

Section 13a2.1 recommends that external events affecting more than one unit be considered as 

a maximum hypothetical accident.

In response to this RAI (Reference 20) SHINE stated that the facility was designed as a robust 

structure to protect equipment contained within the seismic envelope from external events such 

as aircraft impact, tornado, flood, earthquake, or tornado missile, thus making an initiating event 

involving one or more irradiation units not credible. SHINE provided additional details on the 

robust design of the primary system boundary in response to RAI 13a.2.1-2 (Reference 20) by 

describing the application of relevant portions of American Society of Mechanical Engineers 

(ASME) Boiler and Pressure Vessel Code (BPVC) sections to the design of TSV, TOGS, and 

TSV dump tank.

The staff finds these responses satisfy the recommendation of the ISG Augmenting 

NUREG-1537, Part 2, Section 13a2.1 and demonstrate an adequate design basis to protect the 

irradiation units from external events and to ensure the integrity of the primary system boundary 

for a preliminary design. The staff will confirm that the final design conforms to this design basis 

during the evaluation of SHINE’s FSAR.

For the analysis of the MHA, the following initial conditions were assumed, among others: (1) 

the presence of the maximum radioisotope inventory in the TSV, (2) the IU cell penetrations are 

sealed to be within design specifications, and (3) deactivation of the neutron driver. In the MHA 

scenario, the inventory of the TSV is instantaneously dumped into the IU cell and no credit is 

taken for light water pool scrubbing and the airborne material is released to the IU cell 

atmosphere. Fission products can be released to the environment through the facility stack 

through the RCA ventilation Zone 1 (RVZ1) flow path. The barriers to release are the filters in 

the RVZ1 and the inlet and outlet dampers of the IU cell. The isolation dampers close due to a 
Accident Analyses

13-7

high radiation signal after about 1 percent of the airborne activity is released to RVZ1. The 

RVZ1 exhaust is equipped with two trains of HEPA filters and carbon adsorber beds that have 

assumed efficiencies of 99 percent for particulates and 95 percent for halogens. These 

efficiencies are expected to be degraded values compared to filter design values. For the MHA, 

it is assumed that 10 percent of the airborne activity is released to the RCA due to the leakage 

characteristics of the IU cell penetrations during the assumed 10 minute worker exposure time. 

This is the dominant dose to the workers. Radiation alarms are assumed to be operating and 

facility personnel are assumed to evacuate the area if an area radiation alarm is activated. 

Evacuation occurs after 25 percent of the activity leaves the TOGS. 

There are five parameters used by the applicant to calculate the airborne and respirable source 

terms that affect the total effective dose equivalent (TEDE). The material at risk (MAR) is the 

total radionuclide source for the accident. The source term for the analysis is the TSV inventory 

after a certain number of irradiation cycles at a conservative power level and maximum fission 

product carryover. The damage ratio (DR) is the fraction of the MAR impacted by the accident 

scenario. The DR for the MHA is 1.0. The leak path factor (LPF) is the fraction of the 

radionuclide that is made airborne. The airborne release fraction (ARF) is the fraction of the 

material that can be suspended in the atmosphere as an aerosol and is subject to airborne 

transport. The respirable fraction (RF) is the fraction of airborne particles and aerosols that can 

be transported through the air and inhaled into the human respiratory system and is assumed to 

include all particles 10 microns and smaller. NRC staff requested, and SHINE provided the 

technical basis for these parameters in RAIs 13a2.2-1, 13a2.2-5, and 13a2.2-6 (References 14, 

and 16, respectively), and their associated responses (References 21, 27 and 24, respectively). 

This information is necessary to satisfy the acceptance criteria in the ISG Augmenting 

NUREG-1537, Part 2, Section 13a2, “Aqueous Homogeneous Reactor Accident Analyses,” 

which states that the applicant should include a systematic analysis and discussion of credible 

accidents for determining the limiting event in each category. The mathematical models and 

analytical methods employed, including assumptions, approximations, validation, and 

uncertainties, should be clearly stated in this analysis. The staff finds that the technical basis 

provided by SHINE satisfies the requirements discussed in the ISG Augmenting NUREG-1537, 

Part 2, Section 13a2 and demonstrates an adequate design basis for a preliminary design. The 

staff will confirm that the final design conforms to this design basis during the evaluation of 

SHINE’s FSAR.

The elevation of the exhaust stack is 66 feet above the site grade. The site boundary is 

approximately 300-350 yards from the exhaust stack and the nearest residence is 0.5 miles 

from the facility.

In the course of review of SHINE’s description of the radiological dose consequence analysis, 

the staff determined that additional information was needed to determine the adequacy of 

SHINE’s radiological dose consequence analysis. Therefore, in RAIs 13a2.2-4 and 13a2.2-7 

(References 14 and 17), the staff requested that SHINE provide information on dose 

calculations, including a description of the methods and codes used, important input parameter 

values, and calculated values of dose components. This information was necessary to satisfy 

the requirements discussed in the ISG Augmenting NUREG-1537, Part 2, Section 13a2, related 

to the demonstration of a systematic analysis of accidents, as described above. In response to 

these RAIs, (Reference 21 and 24), SHINE provided information related to important 

assumptions for radiological dose calculations, dose calculation methodology, internal dose, 

external dose equivalent, organ dose, off-site dose, input parameter values, and dose 

calculation results. The staff finds that descriptions of methods and codes used, input 

parameter values, and calculated values of dose components provided by SHINE in response to 
Accident Analysis

13-8

these RAIs satisfies the requirements discussed in the ISG Augmenting NUREG-1537, Part 2, 

Section 13a2 and demonstrates an adequate design basis for a preliminary design. The staff 

will confirm that the final design conforms to this design basis during the evaluation of SHINE’s 

FSAR.

SHINE calculated that the dose consequences of the MHA are calculated to be within the 

regulatory limits of 10 CFR Part 20. A TEDE of 3.06 rem was calculated for the workers at the 

facility. This on-site dose is less than the 5 rem regulatory limit specified in 10 CFR 20.1201. A 

TEDE of 0.0165 rem is calculated for a member of the public at the site boundary, and a TEDE 

of 0.0023 rem is calculated at the nearest residence. The off-site doses are less than the 0.1 

rem regulatory limit specified in 10 CFR 20.1301. The NRC staff will confirm these calculations 

prior to issuing an operating license, but the results do not need to be confirmed for issuing a 

construction permit.

Because the assumptions of the scenario are bounding, the doses calculated will likely not be 

exceeded by any accident considered credible. The applicant has also examined more realistic 

assumptions about operating time and release fractions that decreased the source term 

significantly, compared to the one calculated for the MHA, lowering the maximum doses by a 

factor of 2 for workers and a factor of 7.5 for members of the public. The staff finds that for the 

IF MHA, the health and safety of the facility staff and the public are protected. 

On the basis of its review, the staff has determined that the level of detail provided on SHINE’s 

MHA demonstrates an adequate design basis for a preliminary design and satisfies the 

applicable acceptance criteria of the ISG Augmenting NUREG-1537, Part 2, Section 13a2, 

allowing the staff to make the following relevant findings: 

(1) The facility power and power density are sufficiently low such that insufficient energy is 

available to drive a large energetic release of radioactive material, as could occur in a 

nuclear power reactor. The analysis of the MHA is sufficiently conservative in that it 

does not take credit for certain mechanisms that would limit the release of fission 

products in a credible release. Any credible release from the irradiation units will go 

into the light water pool, which should provide scrubbing and control the release rates 

of iodine and bromine. The predominant form of iodine in the light water pool and its 

volatility will depend on the pH of the pool, which will be evaluated during the final 

design of the LWPS. The pH of an aqueous solution generally determines whether 

iodine is in a non-volatile (I-) or volatile (I2) form. In acidic conditions I2 is preferred 

resulting in transfer of iodine to the gaseous phase. If organics are present they can 

react with iodine to form organic iodides some of which can also transfer to the 

gaseous phase. Judging from the behavior of organic iodine Radioiodine Test Facility 

(RTF) tests described in the Behavior of Iodine Project Final Summary Report, 

NEA/CSNI/R(2011)11 (https://www.oecd-nea.org/nsd/docs/2011/csni-r2011-11.pdf), 

the organic iodide concentration seems to follow the same trends as I2. The organic 

iodide concentration decreases along with the reduction in the molecular iodine (I2) 

concentration with increasing pH. This reduction of the organic iodide concentration 

suggests that controlling pH would similarly control the organic iodide production and 

potential release to the gas phase. The radiolytic degradation of certain organics was 

also observed to influence pH. The RTF experiments were intended to represent 

containment sump water. It is therefore possible that additional reactions may alter the 

organic iodide behavior observed in the RTF tests. The potential for change in 

releases should be examined in more detail considering composition of and the 

organic contaminants expected in the TSV solution when final design information 
Accident Analyses

13-9

becomes available in the operating license review. While the applicant has not 

provided the anticipated pH of the light water pool in the IU following the postulated 

accident in which the entire contents of the TSV are released, the volume of the pool 

would increase the pH of the mixture, limiting potential releases by this pathway. 

Iodine releases would also be controlled by adsorption on the walls of the light water 

pool, as well as the mixing in the pool and transport of iodine to the gas space. 

(2) The exposure time of workers is assumed to be 10 minutes which is conservative for 

workers trained to evacuate in the event of a radiological release.

(3) For the preliminary design, the air handling and filtering systems are assumed to 

function as designed and described in the SHINE PSAR. Realistic methods were used 

to compute external radiation doses and dose commitments resulting from inhalation 

by the facility staff. As described in SHINE PSAR Chapter 11, “Radiation Protection 

Program and Waste Management,” and supplemented by responses to RAIs, realistic 

but conservative methods are used to compute potential doses and dose commitments 

to the public in the unrestricted area. The methods of calculating doses from 

inhalation or ingestion (or both) and direct shine of gamma rays from dispersing 

plumes of airborne radioactive material are appropriate for a preliminary facility design.

(4) An MHA, which is an accident that would release fission products from target solution 

and would have consequences greater than any credible accident, has been analyzed. 

The MHA scenario is credible, but the combination of bounding conditions analyzed 

are beyond what is assumed for design basis accidents. The IF MHA serves as a 

bounding accident analysis for the IF.

(5) Because the assumptions of the scenario are bounding, the doses calculated will likely 

not be exceeded by any accident considered credible. The applicant has also 

examined more realistic assumptions about operating time and release fractions that 

decreased the source term significantly compared to the one calculated for the MHA, 

lowering the maximum doses by a factor of 2 for workers and a factor of 7.5 for 

members of the public. Thus, even for the IF MHA, the health and safety of the facility 

staff and the public are protected.

Based on the above, the staff finds that the preliminary analysis of the MHA, as described in 

SHINE PSAR Sections 13a2.1.1 and 13a2.2.1, and supplemented by the applicant’s responses 

to RAIs, is sufficient and meets the applicable regulatory requirements and guidance for the 

issuance of a construction permit in accordance with 10 CFR 50.35 and 50.40. Further 

technical or design information required to complete the safety analysis may reasonably be left 

for later consideration. The staff will confirm that the final design conforms to the design basis 

during the evaluation of SHINE’s FSAR.

13a.4.2 Insertion of Excess Reactivity/Inadvertent Criticality

In SHINE PSAR Sections 13a2.1.2, “Insertion of Excess Reactivity/Inadvertent Criticality,” and 

13a2.2.2, “Excess Reactivity Insertion Accident,” the applicant examined modes of operation 

including the fill process, the cold target solution prior to starting the neutron driver, and 

irradiation operations after the neutron driver is activated. The TSV is expected to operate in a 

subcritical condition during all modes of operation through a combination of automatic safety 

systems and administrative controls, including a passive standpipe overflow system and fill rate 
Accident Analysis

13-10

limits. The keff is expected to be at a maximum at the end of the filling mode. The keff will be 

reduced during irradiation operations due to void and temperature feedback in the target 

solution.

SHINE selected and analyzed three potential events, which could result in the insertion of 

excess reactivity:

A. Increase in the target solution density during operations due to void collapse.

B. Reduction in the target solution temperature due to excessive cooling.

C. Injection of additional target solution beyond the targeted fill volume during startup and 

irradiation operations. 

SHINE PSAR Section 13a2.1.2.1, “Identification of Causes, Initial Conditions, and 

Assumptions,” discusses the insertion of excess reactivity. Since the system is over-moderated, 

decreasing the density of the coolant or introducing voids in the primary closed loop cooling 

system (PCLS) would result in a negative reactivity insertion. In its review of SHINE’s analysis 

of potential events which could result in an insertion of excess reactivity, the staff determined 

that additional information was necessary to determine whether certain events had been 

considered, which could result in an insertion of reactivity and/or inadvertent criticality event. 

Therefore, in RAIs 13a2.1-3 through 5 and 13a2.2-2 (Reference 14), the staff requested that 

SHINE provide additional information on: (1) whether a decrease in coolant density or 

introduction of voids in the PCLS has been analyzed as a possible accident scenario, (2) 

whether a TOGS condenser heat exchanger (HX) failure or recombiner HX failure and water 

ingress had been considered as a possible accident scenario, (3) the expected reactivity 

insertion, following the maximum credible deflagration, and (4) what features limit a temperature 

drop in the subcritical assembly to 5 degrees C to prevent a criticality event. This information is 

necessary to satisfy the requirements discussed in the ISG Augmenting NUREG-1537, Part 2, 

Section 13a2, “Aqueous Homogeneous Reactor Accident Analyses,” which states that the 

applicant should include a systematic analysis and discussion of credible accidents for 

determining the limiting event in each category. The mathematical models and analytical 

methods employed, including assumptions, approximations, validation, and uncertainties, 

should be clearly stated in this analysis.

In response to RAI 13a2.1-3 (Reference 21), SHINE performed a calculation of the expected 

reactivity changes due to voiding out the PCLS from nominal coolant temperature and density to 

a fully voided cooling system and found that there is a negative insertion of reactivity as the 

percent of voids increased. The highest keff for both Mode 1 and Mode 2 conditions occurred 

when there were no voids present in the PCLS.

In response to RAI 13a2.1-4 (Reference 21), SHINE stated that the TOGS condenser heat 

exchanger failure and recombiner heat exchanger failure and water ingress had been 

considered as possible accident scenarios. SHINE performed calculations showing that these 

events would result in a dilution of the TSV solution and rise in TSV solution level, resulting in a 

reactivity decrease.

In response to RAI 13a2.1-5 (Reference 21), SHINE calculated the expected reactivity insertion 

from the maximum credible deflagration and found that the increase in solution concentration 

due to water loss combined with the maximum deflagration event did not result in a keff greater 

than that occurring during cold startup. The calculation was performed using MCNP5, 

version 1.60, and the SHINE best-estimate neutronics model.
Accident Analyses

13-11

In response to RAI 13a2.2.-2 (Reference 20), SHINE described two features that limit the 

temperature drop in the subcritical assembly during startup: temperature detection of the PCLS 

and neutron flux monitoring of the subcritical assembly. Furthermore, SHINE stated that 

“[a]ssuming the least negative initial reactivity and the limiting TSV temperature reactivity 

coefficient, the TSV temperature would have to drop approximately 6°C before reaching 

criticality.”

The staff finds these responses satisfy the requirements discussed in the ISG Augmenting 

NUREG-1537, Part 2, Section 13a2 and demonstrate an adequate design basis to protect the 

irradiation units from an insertion of reactivity event and inadvertent criticality event for a 

preliminary design. The staff will confirm that the final design conforms to this design basis 

during the evaluation of SHINE’s FSAR.

On the basis of its review, the staff has determined that the level of detail provided on SHINE’s 

insertion of reactivity and inadvertent criticality events demonstrates an adequate design basis 

for a preliminary design and satisfies the applicable acceptance criteria of the ISG Augmenting 

NUREG-1537, Part 2, Section 13a2, allowing the staff to make the following relevant findings: 

(1) Reactivity insertion events have been identified and analyzed. None of these events 

would lead to challenges to the integrity of the primary system boundary or increase 

the release of radiation from the irradiation units. The SHINE irradiation units are 

designed to operate with a significant margin to criticality in all modes of operation. 

The physical design features, safety system trips, technical specifications and 

administrative controls will ensure that the system remains subcritical in all modes of 

operation. There is no scenario that allows a large and rapid reactivity insertion similar 

to a control rod ejection event in a reactor. While SHINE did not analyze an event that 

would cause a criticality, in the unlikely event that all safety trips and administrative 

controls failed and resulted in a SHINE IU criticality, the response of critical aqueous 

homogenous reactors to reactivity insertions is well understood and should not lead to 

any challenges to the integrity of the primary system boundary.

(2) There are no dose consequences identified for either on-site workers or the public. 

The consequences of excess reactivity insertion accidents have been analyzed and 

shown to be bounded by the MHA. Radiation doses to the public and staff will be 

within acceptable limits, and the health and safety of the staff and public will be 

adequately protected.

Therefore, the staff finds that the preliminary analysis of the insertion of reactivity and 

inadvertent criticality events, as described in SHINE PSAR Sections 13a2.1.2 and 13a2.2.2, and 

supplemented by the applicant’s responses to RAIs, is sufficient and meets the applicable 

regulatory requirements and guidance for the issuance of a construction permit in accordance 

with 10 CFR 50.35 and 50.40. Further technical or design information required to complete the 

safety analysis may reasonably be left for later consideration. The staff will confirm that the final 

design conforms to the design basis during the evaluation of SHINE’s FSAR.

13a.4.3 Reduction in Cooling

In SHINE PSAR Sections 13a2.1.3 and 13a2.2.3, “Reduction in Cooling,” the applicant 

evaluated a reduction in cooling to the neutron driver, the neutron multiplier, and to the TSV, 

which contains the target solution. The IU and TSV are cooled by the PCLS and the LWPS. 
Accident Analysis

13-12

The PCLS removes heat from the TSV by circulation coolant. The LWPS cools the pool 

surrounding the TSV. 

Several scenarios were identified that would lead to a reduction in cooling event including a 

loss-of-offsite-power (LOOP) event, flow blockages, equipment malfunctions or damage, or 

operator errors. The applicant postulated reduction in cooling events with both operating and 

de-energized neutron drivers. The applicant performed a detailed analysis of three potential 

scenarios that could result in a reduction in cooling:

A. A LOOP resulting in a loss of the PCLS, LWPS and the neutron driver.

B. Loss of PCLS due to a blockage, malfunction, damage, or operator error with the 

neutron driver still operating.

C. Loss of PCLS and LWPS due to an electrical failure or operator error with the neutron 

driver still operating. 

The staff determined that these scenarios cover a representative sample of possible reduction 

in cooling scenarios and should provide representative results for the range of safety margins 

and consequences seen in actual reduction of cooling events during facility operations. For all 

of these scenarios the TRPS system trips on a loss of cooling and target solution is transferred 

to the TSV dump tank. However, the staff determined that additional information was needed to 

understand the basis for SHINE PSAR Section 13a2.1.3.1, “Identification of Causes, Initial 

Conditions, and Assumptions,” stating that Scenario C was a low probability event not expected 

to occur during the facility lifetime. Therefore, SHINE was asked to provide a technical basis for 

this claim in RAI 13a2.1-6 (Reference 14). This information is necessary to satisfy the 

requirements discussed in the ISG Augmenting NUREG-1537, Part 2, Section 13a2, which 

states that the applicant should include a systematic analysis and discussion of credible 

accidents for determining the limiting event in each category. The mathematical models and 

analytical methods employed, including assumptions, approximations, validation, and 

uncertainties, should be clearly stated in this analysis.

In response to RAI 13a2.1-6 (Reference 21), SHINE stated that multiple unlikely simultaneous 

failures would be required to result in continued operation of the neutron driver during the loss 

or reduced PCLS and LWPS flow. The neutron driver would be de-energized during both a 

LOOP and during a loss or reduction of PCLS flow below the trip setpoint.

The staff finds that this response satisfies the requirements discussed in the ISG Augmenting 

NUREG-1537, Part 2, Section 13a2 and demonstrates an adequate design basis to protect the 

irradiation units from a reduction in cooling event for a preliminary design. The staff will confirm 

that the final design conforms to this design basis during the evaluation of SHINE’s FSAR.

On the basis of its review, the staff has determined that the level of detail provided on SHINE’s 

reduction of cooling scenarios demonstrates an adequate design basis for a preliminary design 

and satisfies the applicable acceptance criteria of the ISG Augmenting NUREG-1537, Part 2, 

Section 13a2, allowing the staff to make the following relevant findings: 

(1) Reduction in cooling events have been identified and analyzed. The level of decay 

heat produced by the target solution is relatively low compared to the heat removal 

capabilities of the cooling systems. The relatively large volume of water in the light 

water pool provides an adequate heat sink and heat removal capacity whether or not 

the LWPS system is operable.
Accident Analyses

13-13

(2) There are no dose consequences for either on site workers or the public. The 

consequences of reduction in cooling events have been analyzed and shown to be 

bounded by the MHA. Radiation doses to the public and staff will be within acceptable 

limits, and the safety and health of the staff and public will be adequately protected.

Therefore, the staff finds that the preliminary analysis of the reduction in cooling scenarios, as 

described in SHINE PSAR Sections 13a2.1.3 and 13a2.2.3, and supplemented by the 

applicant’s response to an RAI, is sufficient and meets the applicable regulatory requirements 

and guidance for the issuance of a construction permit in accordance with 10 CFR 50.35 and 

50.40. Further technical or design information required to complete the safety analysis may 

reasonably be left for later consideration. The staff will confirm that the final design conforms to 

the design basis during the evaluation of SHINE’s FSAR.

13a.4.4 Mishandling or Malfunction of Target Solution

SHINE PSAR Sections 13a2.1.4 and 13a2.2.4, “Mishandling or Malfunction of Target Solution,” 

describe the IF as containing a liquid uranyl sulfate target solution that may include radioactive 

fission products. This accident category includes events that involve the mishandling of the 

target solution and the failure of the primary system boundary within the IF. The solution may 

be contained within the target solution hold tank, the TSV, TSV dump tank, or any of associated 

piping in the system. The applicant considered four general scenarios that qualitatively differ by 

where the target solution goes. In the TSV overfill scenario, the excess target solution goes into 

the dump tank and there is no leakage outside of the primary pressure boundary. A TSV or 

dump tank leak into the light water pool was considered where the solution enters the pool and 

pool cooling system. Fission products in the pool could also enter the IU atmosphere above the 

pool and be released into RVZ1 and the RCA as in the MHA for the IF. The release rate is 

much slower than the MHA and credit is given for fission product scrubbing in the pool. A TSV 

leak into the primary cooling system would allow radioactive water to exit the IU cell, but still 

remain in the closed PCLS. The PCLS is normally operating at a higher pressure than the TSV, 

so the expected direction of leakage is from the PCLS to the TSV. 

A dump tank pipe leak in the IU cell atmosphere was considered to be the limiting event in this 

category. In this event, there would not be fission product scrubbing by the pool. This event is 

similar but less severe than the MHA since the leak rate is slower than the instantaneous loss of 

all target solution in the MHA. Assumptions used in the accident analysis are:

• The scenario analyzed by the applicant starts with a pipe break in the TSV dump tank 

outlet piping and 25 percent of the inventory is released into the IU cell gas space. 

• The facility is evacuated after 25 percent of the TSV inventory enters the IU cell. 

• A high radiation signal activates the isolation dampers after 1 percent of the total activity 

is released into RVZ1.

• The airborne activity is filtered before being released to the environment.

• Ten percent of the activity in the shielded cell is released into the RCA through 

penetration leakage.
Accident Analysis

13-14

• Radiation alarms in the facility are operating to notify personnel in the area of the 

release.

• Facility personnel evacuate the area when the radiation alarm activates.

The airborne activity is released to an IU cell gas space. One percent of the activity is released 

to RVZ1 before the IU cell isolation dampers are closed. The airborne activity in RVZ1 is 

released to the environment through HEPA and carbon adsorber beds with assumed removal 

efficiencies of 99 percent or particulates and 95 percent of halogens. Ten percent of the IU cell 

activity is released to the RCA through IU cell penetrations.

The dose consequences of the TSV dump tank exit piping rupture are calculated to be within 

the regulatory limits of 10 CFR Part 20. A TEDE of 1.50 rem is calculated for the workers at the 

facility. This on-site dose is less than the 5 rem regulatory limit specified in 10 CFR 20.1201. A 

TEDE of 0.0022 rem is calculated for a member of the public at the site boundary, and a TEDE 

of 0.0003 rem is calculated at the nearest residence. The off-site doses are less than the 0.1 

rem regulatory limit specified in 10 CFR 20.1301.

On the basis of its qualitative review, the staff finds that the level of detail provided on SHINE’s 

mishandling or malfunction of target solution event demonstrates an adequate design basis for

a preliminary design and satisfies the applicable acceptance criteria of the ISG Augmenting 

NUREG-1537, Part 2, Section 13a2, allowing the staff to make the following relevant findings: 

(1) Mishandling and malfunction of the target solution scenarios have been identified and 

analyzed. The facility power and power density are sufficiently low such that 

insufficient energy is available to drive a large energetic release of radioactive 

material, as could occur in a nuclear power reactor. Any release in this scenario will 

enter into the gas space of the IU. Iodine releases would be controlled by adsorption 

on the walls of the light water pool, as well as the mixing in the pool and transport of 

iodine to the gas space. 

(2) The exposure time of workers is assumed to be 10 minutes, which is conservative for 

workers trained to evacuate in the event of a radiological release.

(3) The applicant adequately considered the consequences of target solution mishandling 

and malfunction events. Because the assumptions of this scenario are bounding, the 

doses calculated for this event are conservative. More realistic assumptions about the 

release fractions would decrease the source term significantly compared to the source 

term assumed for this scenario. The consequences of the IF mishandling or 

malfunction of target solution event have been analyzed and shown to be bounded by 

the MHA. Radiation doses to the public and staff will be within acceptable limits, and 

the safety and health of the staff and public will be adequately protected.

Therefore, the staff finds that the preliminary analysis of the IF mishandling or malfunction of 

target solution event, as described in SHINE PSAR Sections 13a2.1.4 and 13a2.2.4, is sufficient 

and meets the applicable regulatory requirements and guidance for the issuance of a 

construction permit in accordance with 10 CFR 50.35 and 50.40. Further technical or design 

information required to complete the safety analysis may reasonably be left for later 

consideration. The staff will confirm that the final design conforms to the design basis during 

the evaluation of SHINE’s FSAR.
Accident Analyses

13-15

13a.4.5 Loss of Electrical Power

In SHINE PSAR Sections 13a2.1.5 and 13a2.2.5, “Loss of Off-Site Power,” the applicant 

examined a total LOOP to the facility for an extended period of time with conservative operating 

conditions as an event that bounds all other loss of power events in the facility. An 

uninterruptable power supply system (UPSS) is available to supply battery power for essential 

loads for at least 2 hours. The neutron driver shuts down on LOOP. The UPSS powers the 

TOGS to remove hydrogen generated by radiolysis. The UPSS does not provide power for the 

heat removal systems connected to the TOGS. The decay heat is low and can be transferred to 

the light water pool through natural convection. The heat capacity of the pool is large enough 

that the pool temperature will increase by only 11.8 °F from 90 days of decay heat load. 

On the basis of its review, the staff has determined that the level of detail provided in SHINE’s 

LOOP analysis demonstrates an adequate design basis for a preliminary design and satisfies 

the applicable acceptance criteria of the ISG Augmenting NUREG-1537, Part 2, Section 13a2, 

allowing the staff to make the following relevant finding: 

There are no dose consequences for either on site workers or the public. While the 

applicant has not provided an analysis of the impact of the loss of the heat removal 

systems on the integrity of the TOGS pressure boundary, the event would still be 

bounded by the MHA. The consequences of reduction in cooling events from loss of 

offsite power have been analyzed and shown to be bounded by the MHA. Radiation 

doses to the public and staff will be within acceptable limits, and the safety and health of 

the staff and public will be adequately protected.

Therefore, the staff finds that the preliminary analysis of the IF LOOP, as described in SHINE 

PSAR Sections 13a2.1.5 and 13a2.2.5, is sufficient and meets the applicable regulatory 

requirements and guidance for the issuance of a construction permit in accordance with 

10 CFR 50.35 and 50.40. Further technical or design information required to complete the 

safety analysis may reasonably be left for later consideration. The staff will confirm that the final 

design conforms to the design basis during the evaluation of SHINE’s FSAR.

13a.4.6 External Events

In SHINE PSAR Sections 13a2.1.6 and 13a2.2.6, “External Events,” the applicant has identified 

seismic events, tornados or high winds, and a small aircraft crash as external events that can 

affect the IF. These are treated as design basis accidents for the facility. Flooding has been 

ruled out due to the site location. The SHINE facility has been designed to survive design basis 

earthquake, tornado and wind loads including missiles, and aircraft impacts and keep the facility 

safety functions intact.

On the basis of its review, the staff has determined that the level of detail provided on SHINE’s 

external events discussion demonstrates an adequate design basis for a preliminary design and 

satisfies the applicable acceptance criteria of the ISG Augmenting NUREG-1537, Part 2, 

Section 13a2, allowing the staff to make the following relevant finding: 

Chapters 2, “Site Characteristics,” and 3, “Design of Structures, Systems, and 

Components,” of the PSAR adequately discuss the preliminary design of the SHINE 

facility and its ability to withstand external events and the potential associated accidents. 

The SHINE facility is adequately designed to accommodate these events. For events 

that cause facility damage, the damage is within the bounds discussed for other 
Accident Analysis

13-16

accidents in this chapter and does not result in dose consequences. The consequences 

of all DBA external events have been analyzed and shown to be bounded by the MHA. 

Radiation doses to the public and staff will be within acceptable limits, and the safety 

and health of the staff and public will be adequately protected.

Therefore, the staff finds that the preliminary analysis of external events, as described in SHINE 

PSAR Sections 13a2.1.6 and 13a2.2.6, is sufficient and meets the applicable regulatory 

requirements and guidance for the issuance of a construction permit in accordance with 

10 CFR 50.35 and 50.40. Further technical or design information required to complete the 

safety analysis may reasonably be left for later consideration. The staff will confirm that the final 

design conforms to the design basis during the evaluation of SHINE’s FSAR.

13a.4.7 Mishandling or Malfunction of Equipment

In SHINE PSAR Sections 13a2.1.7 and 13a2.2.7, “Mishandling or Malfunction of Equipment 

Affecting the PSB,” the applicant examined scenarios where mishandling of malfunction of 

equipment could lead to an accident where workers or the public are exposed to radiation. This

includes scenarios where the PSB is not maintained. Some of those that could lead to a 

release of the target solution have already been examined in Section 13a2.1.4 of the PSAR. 

This section examines scenarios that could lead to radiation exposure including the release of 

radioactive gases. 

The malfunctions of three systems were identified for further analysis. Events involving the 

Neutron Driver Assembly System (NDAS) and the tritium purification system (TPS) were 

identified as possible scenarios. Those scenarios include inadvertent actuation of the neutron 

driver, misalignment of the accelerator, and loss of tritium. There are specific design and safety 

system features that minimize the potential for events involving those systems. They are not 

the limiting events but they are analyzed further in facility specific events category which is 

described in PSAR Section 13a2.1.12.

A scenario where there is an inadvertent purge of the radioactive gases from the TOGS has 

been determined to be the limiting event in this category. The TOGS contains an inventory of 

radioactive fission product gases that build up over the irradiation cycle. Part of the iodine is 

removed by the zeolite beds that are part of the TOGS system. Gas is purged from the TOGS 

to the Noble Gas Removal System after an irradiation cycle. This scenario assumes that a 

malfunction or human error releases radioactive gas in one IU from the TOGS into the shielded 

cell that encloses the TOGS. Assumptions used in the accident analysis are:

• The scenario analyzed by the applicant starts with a pipe rupture in the TOGS and the 

complete release of the off gas into the TOGS shielded cell. 

• The facility is evacuated after 25 percent of the TOGS radioactivity enters the shielded 

cell. 

• A high radiation signal activates the isolation dampers after 1 percent of the total activity 

is released into RVZ1.

• The airborne activity is filtered before being released to the environment.
Accident Analyses

13-17

• Ten percent of the activity in the shielded cell is released into the RCA through 

penetration leakage.

• Radiation alarms in the facility are operating to notify personnel in the area of the 

release.

• Facility personnel evacuate the area when the radiation alarm activates.

The radioactive gas is released to a TOGS cell gas space. One percent of the activity is 

released to RVZ1 before the IU cell isolation dampers are closed. The airborne activity in RVZ1 

is released to the environment through HEPA and carbon adsorber beds with assumed removal 

efficiencies of 99 percent of particulates and 95 percent of halogens. Ten percent of the IU cell 

activity is released to the RCA through IU cell penetrations.

The applicant calculated that the dose consequences of the TOGS piping rupture are calculated 

to be within the regulatory limits of 10 CFR Part 20. A TEDE of 1.87 rem is calculated for the 

workers at the facility. This on-site dose is less than the 5 rem regulatory limit specified in 

10 CFR 20.1201. A TEDE of 0.0159 rem is calculated for a member of the public at the site 

boundary, and a TEDE of 0.0022 rem is calculated at the nearest residence. The off-site doses 

are less than the 0.1 rem regulatory limit specified in 10 CFR 20.1301.

On the basis of its review, the staff has determined that the level of detail provided on 

mishandling or malfunction of equipment demonstrates an adequate design basis for a 

preliminary design and satisfies the applicable acceptance criteria of the ISG Augmenting 

NUREG-1537, Part 2, Section 13a2, allowing the staff to make the following relevant findings:

(1) Mishandling and malfunction of equipment scenarios have been identified and 

analyzed. The facility power and power density are sufficiently low such that 

insufficient energy is available to drive a large energetic release of radioactive 

material, as could occur in a nuclear power reactor. Any release in this scenario will 

enter into the gas space of the IU. Iodine releases would be controlled by adsorption 

on the walls of the light water pool, as well as the mixing in the pool and transport of 

iodine to the gas space. 

(2) The exposure time of workers is assumed to be 10 minutes, which should be 

conservative for workers trained to evacuate in the event of a radiological release.

(3) The applicant adequately considered the consequences of target solution mishandling 

and malfunction events. Because the assumptions of the scenario are bounding, the 

doses calculated for this event will be conservative. More realistic assumptions about 

the release fractions would decrease the source term significantly compared to the 

source term assumed for this scenario. The consequences of the IF mishandling or 

malfunction of equipment affecting the PSB event have been analyzed and shown to 

be bounded by the MHA. Radiation doses to the public and staff will be within 

acceptable limits, and the safety and health of the staff and public will be adequately 

protected.

Therefore, the staff finds that the preliminary analysis of mishandling or malfunction of 

equipment events, as described in SHINE PSAR Sections 13a2.1.7 and 13a2.2.7, is sufficient 

and meets the applicable regulatory requirements and guidance for the issuance of a 

construction permit in accordance with 10 CFR 50.35 and 50.40. Further technical or design 
Accident Analysis

13-18

information required to complete the safety analysis may reasonably be left for later 

consideration. The staff will confirm that the final design conforms to the design basis during 

the evaluation of SHINE’s FSAR.

13a.4.8 Large Undamped Power Oscillations

SHINE PSAR Sections 13a2.1.8 and 13a2.2.8, “Large Undamped Power Oscillations,” describe 

the conditions when power oscillations may occur in the TSV in response to natural fluctuations 

in the target solution that result in fluctuations in reactivity. The size of the power oscillations 

will be determined by the physical characteristics of the system and any control inputs or 

changes to the TSV boundary conditions including the neutron driver, the primary heat 

exchanger, the autocatalytic recombiner, and the condenser. However, the operating conditions 

of the TSV and TOGS should not lead to large undamped power oscillations. 

The applicant identified radiolytic bubble formation and transport, target solution spatial 

variations and circulation, neutron driver variation, and excessive reactivity insertions as 

possible causes of oscillations. The SHINE TSV operates at power densities significantly below 

the 1.8 kWt/L threshold observed to cause significant power oscillations in aqueous 

homogeneous reactors. The low operating power density and the subcritical driven operation 

should prevent large power oscillations. However, the NRC staff determined that additional 

information was necessary to verify that the TSV would not become critical during operation. 

Therefore, in RAI 13a2.1-7 (Reference 14), the NRC staff requested that SHINE provide the 

expected magnitude of potential power oscillations, and a description of the mechanisms that 

are in place to ensure that they are “self-limiting.” This information is necessary to satisfy the 

requirements discussed in the ISG Augmenting NUREG-1537, Part 2, Section 13a2, which 

states that the applicant should include a systematic analysis and discussion of credible 

accidents for determining the limiting event in each category. In response to this RAI 

(Reference 21), SHINE provided a stability analysis of the accelerator driven system that was 

performed by Los Alamos National Laboratory (LANL) and documented in the report 

LA-UR-14-28684, “STABILITY OF FISSILE SOLUTION SYSTEMS.” The LANL stability 

analysis showed that the system is stable across the expected range of operation and any 

oscillations should be damped. Driven bounded reactivity or source strength oscillations will 

also result in a bounded response. The system is expected to be stable to bounded 

perturbations. However, feedback effects from the recombiner and condenser were not 

included in the stability analysis and will need to be evaluated during the evaluation of the final 

design of the SHINE facility. The staff finds that this response satisfies the requirements 

discussed in the ISG Augmenting NUREG-1537, Part 2, Section 13a2 and demonstrates an 

adequate design basis to protect the irradiation units from a large undamped power oscillation 

for a preliminary design. 

On the basis of its review, the staff has determined that the level of detail provided on large 

undamped power oscillations demonstrates an adequate design basis for a preliminary design 

and satisfies the applicable acceptance criteria of the ISG Augmenting NUREG-1537, Part 2, 

Section 13a2, allowing the staff to make the following relevant finding:

The applicant has evaluated potential unstable (growing), large undamped power 

oscillations and demonstrated that these oscillations are either not possible, or, if they 

develop, can be readily detected and suppressed so that the IU reaches a stable state. 

There are no dose consequences for either on site workers or the public for these events. 
Accident Analyses

13-19

The consequences of large undamped power oscillations have been analyzed and shown to 

be bounded by the MHA. Radiation doses to the public and staff will be within acceptable 

limits, and the safety and health of the staff and public will be adequately protected.

Therefore, the staff finds that the preliminary analysis of large undamped power oscillations, as 

described in SHINE PSAR Sections 13a2.1.8 and 13a2.2.8, is sufficient and meets the 

applicable regulatory requirements and guidance for the issuance of a construction permit in 

accordance with 10 CFR 50.35 and 50.40. Further technical or design information required to 

complete the safety analysis (e.g., feedback effects from the recombiner and condenser) may 

reasonably be left for later consideration. The staff will confirm that the final design conforms to

the design basis during the evaluation of SHINE’s FSAR.

13a.4.9 Detonation and Deflagration

In SHINE PSAR Sections 13a2.1.9 and 13a2.2.9, “Detonation and Deflagration in Primary 

System Boundary,” the applicant analyzed the effects of a possible hydrogen detonation or 

deflagration within the primary system boundary on the IF. Irradiating the target solution 

produces significant quantities of hydrogen and oxygen through radiolysis and small amounts of 

fission product gases. The TOGS is designed to control the level of hydrogen and oxygen so 

that a deflagration or detonation does not occur. The hydrogen and oxygen is recombined, 

condensed, and returned as water to the TSV by the TOGS. The applicant has identified failure 

or degradation of the TOGS as an initiating event that could lead to a deflagration or detonation.

The primary system boundary is designed to be capable of withstanding all credible 

deflagrations and detonations. However, if the primary system did fail, there could be a 

radioactive release into the IU and the evolution of the event would be similar to the Mishandling 

or Malfunction of Target Solution scenario.

On the basis of its review, the staff has determined that the level of detail provided on 

detonation and deflagration events demonstrates an adequate design basis for a preliminary 

design and satisfies the applicable acceptance criteria of the ISG Augmenting NUREG-1537, 

Part 2, Section 13a2, allowing the staff to make the following relevant finding:

The applicant has evaluated the consequences of potential deflagration or detonation of 

combustible gases within the primary boundary. The assumptions regarding the impact of 

potential explosions on primary boundary integrity are valid. There are no dose 

consequences for either on site workers or the public for these events. The consequences 

of detonation or deflagration events have been analyzed and shown to be bounded by the 

MHA. Radiation doses to the public and staff will be within acceptable limits, and the safety 

and health of the staff and public will be adequately protected.

Therefore, the staff finds that the preliminary analysis of detonation and deflagration events, as 

described in SHINE PSAR Sections 13a2.1.9 and 13a2.2.9, is sufficient and meets the 

applicable regulatory requirements and guidance for the issuance of a construction permit in 

accordance with 10 CFR 50.35 and 50.40. Further technical or design information required to 

complete the safety analysis may reasonably be left for later consideration. The staff will 

confirm that the final design conforms to the design basis during the evaluation of SHINE’s 

FSAR.
Accident Analysis

13-20

13a.4.10 Unintended Exothermic Chemical Reactions Other Than Explosion

As described in SHINE PSAR Sections 13a2.1.10 and 13a2.2.10, “Unintended Exothermic 

Chemical Reactions Other than Detonation,” there is no potential for the target solution to 

undergo any significant exothermic chemical reactions. While the zirconium TSV could react 

with oxygen or steam at high temperature, operating conditions should preclude conditions 

where there would be a significant reaction rate.

On the basis of its review, the staff has determined that the level of detail provided on 

unintended exothermic chemical reactions other than explosions demonstrates an adequate 

design basis for a preliminary design and satisfies the applicable acceptance criteria of the ISG 

Augmenting NUREG-1537, Part 2, Section 13a2, allowing the staff to make the following 

relevant finding:

Since there is no potential for the target solution to undergo any significant exothermic 

chemical reactions, there are no dose consequences for either on site workers or the public 

for these events. The consequences of these events have been analyzed and shown to be 

bounded by the MHA. Radiation doses to the public and staff will be within acceptable 

limits, and the safety and health of the staff and public will be adequately protected.

Therefore, the staff finds that the preliminary analysis of unintended exothermic chemical 

reactions other than explosions, as described in SHINE PSAR Sections 13a2.1.10 and 

13a2.2.10, is sufficient and meets the applicable regulatory requirements and guidance for the 

issuance of a construction permit in accordance with 10 CFR 50.35 and 50.40. Further 

technical or design information required to complete the safety analysis may reasonably be left 

for later consideration. The staff will confirm that the final design conforms to the design basis 

during the evaluation of SHINE’s FSAR.

13a.4.11 Primary System Boundary System Interaction Events

As described in SHINE PSAR Sections 13a2.1.11 and 13a2.2.11, “Primary System Boundary 

System Interaction Events,” the applicant considered events that could result from system 

interactions within the IF and interactions between the IF and RPF. The PSB is located within 

the IF and consists of the TSV, the TSV dump tank, and the TOGS. An event affecting the IF 

would have to cause a breach of the PSB to have dose consequences to workers or the public.

The applicant considered three categories of system interactions in the PSAR:

(1) functional interactions

(2) spatial interactions

(3) human-intervention interactions

Functional interactions are interactions between systems that have a common interface. An 

example in this category is the RPCS, which provides the cooling for the water for many safety 

system heat exchangers including the PLCS, LWPS, and TOGS heat removal systems. A 

failure in the RPCS could affect all of the systems that rely on it. Spatial interactions are 

interactions that can occur between systems that do not have a common interface but they are 

located within close proximity of each other. An example of this is that the failure of one system 

can damage another system that is nearby. Human-intervention interactions are human errors 

made in one system that can cause an adverse effect in another system. An example is that a 

failure in the fuel mixing system can cause an excess reactivity event in the TSV.
Accident Analyses

13-21

The applicant identified that the events considered in this category have been considered and 

bounded by events in other categories and will not be discussed further.

One event that has not been analyzed in detail is an opening of the pressure safety valve on the 

PSB. The pressure safety valve is connected to the TOGS piping to passively prevent an over 

pressurization within the PSB, which may cause structural damage. The setpoint of the 

pressure safety valve will not exceed the design pressure of the PSB components. While the 

details of the system, including the setpoint value are not available in the PSAR, they will be 

provided in the FSAR. Since the TOGS system contains radioactive fission products, an event 

which causes the safety valve to open would allow fission products to exit the PSB and 

discharged to the Noble Gas Removal System (NGRS). SHINE intends to design the NGRS so 

that it has enough volume to receive the gas from the TOGS in an overpressure event and stay 

within pressure design limits. Although this event may not be as limiting as the events analyzed 

in the accident analysis, it may be more credible and occur with a higher probability. Therefore, 

an overpressure event that opens the pressure relief valve and discharges radioactive gas 

should be identified and analyzed in the FSAR to demonstrate the capability of the system to 

mitigate an overpressure event.

On the basis of its review, the staff has determined that the level of detail provided on primary 

system boundary system interaction events demonstrates an adequate design basis for a 

preliminary design and satisfies the applicable acceptance criteria of the ISG Augmenting 

NUREG-1537, Part 2, Section 13a2, allowing the staff to make the following relevant finding:

There are no dose consequences for either on site workers or the public for these events. 

The consequences of PSB interaction events have been analyzed and shown to be 

bounded by the MHA. Radiation doses to the public and staff will be within acceptable 

limits, and the safety and health of the staff and public will be adequately protected.

Therefore, the staff finds that the preliminary analysis of primary system boundary system 

interaction events, as described in SHINE PSAR Sections 13a2.1.11 and 13a2.2.11, is sufficient 

and meets the applicable regulatory requirements and guidance for the issuance of a 

construction permit in accordance with 10 CFR 50.35 and 50.40. Further technical or design 

information required to complete the safety analysis may reasonably be left for later 

consideration. The staff will confirm that the final design conforms to the design basis during 

the evaluation of SHINE’s FSAR.

13a.4.12 Inadvertent Exposure to Neutrons from the Neutron Driver

As described in SHINE PSAR Sections 13a2.1.12.1 and 13a2.2.12.1, “Inadvertent Exposure to 

Neutrons from the Neutron Driver,” each irradiation unit contains a neutron driver, a neutron 

multiplier, and the subcritical uranyl sulphate contained in the TSV. These are all sources of 

neutrons during operations. The unexpected presence of personnel in the IU cell during 

operation of the neutron driver could expose those personnel to significant doses of neutron 

radiation. The applicant considered possible ways that this could occur and concluded that the 

event could be caused by either failure to control access to the IU cell during operation or failure 

to control neutron driver operation during maintenance.

The IU is shielded during normal operations by 6-foot thick concrete walls. Access is available 

to the unit through the IU cell concrete shield plug or the personnel access door. Personnel are 

only expected to be in the IU during maintenance activities when the driver is not operating. 

The possible scenarios that may occur under the failure to control access initiating event include 
Accident Analysis

13-22

inadvertently removing the concrete shield plug or inadvertently opening the personnel access 

door. The scenario for the failure to control neutron driver operation involves personnel in the 

opened IU cell during maintenance activities while the neutron driver is inadvertently activated.

On the basis of its review, the staff has determined that the level of detail provided on 

inadvertent exposure to neutrons from the neutron driver demonstrates an adequate design 

basis for a preliminary design and satisfies the applicable acceptance criteria of the ISG 

Augmenting NUREG-1537, Part 2, Section 13a2, allowing the staff to make the following 

relevant findings:

(1) The applicant has prevented the possible exposure of workers to neutron radiation 

from the neutron driver through safety controls including an interlock system for the 

neutron driver personnel access door and administrative controls on access to the IU 

and operation of the neutron driver.

(2) There are no dose consequences for either on site workers or the public for these 

events. The consequences of these events have been analyzed and shown to be 

bounded by the MHA. Radiation doses to the public and staff will be within acceptable 

limits, and the safety and health of the staff and public will be adequately protected.

Therefore, the staff finds that the preliminary analysis of inadvertent exposure to neutrons from 

the neutron driver, as described in SHINE PSAR Sections 13a2.1.12.1 and 13a2.2.12.1,is 

sufficient and meets the applicable regulatory requirements and guidance for the issuance of a 

construction permit in accordance with 10 CFR 50.35 and 50.40. Further technical or design 

information required to complete the safety analysis may reasonably be left for later 

consideration. The staff will confirm that the final design conforms to the design basis during 

the evaluation of SHINE’s FSAR.

13a.4.13 Irradiation Facility Fires

As described in SHINE PSAR Sections 13a2.1.12.2 and 13a2.2.12.2, “Irradiation Facility Fires,” 

the IF contains the IUs, the TOGS cells, the cooling system, and other related electrical and 

mechanical systems. In addition to combustibles related to the equipment, there is also the 

potential for hydrogen to be in the area.

The applicant identified potential fire events in the IF that could occur during operations and 

maintenance activities and lead to radioactive releases. Fires that started inside the IF and 

external fires that propagate into the IF were considered. Both in-situ and transient sources of 

combustible material were considered as fuel sources for the fire. 

On the basis of its review, the staff has determined that the level of detail provided on Irradiation 

Facility Fires demonstrates an adequate design basis for a preliminary design and satisfies the 

applicable acceptance criteria of the ISG Augmenting NUREG-1537, Part 2, Section 13a2, 

allowing the staff to make the following relevant finding:

Fires are expected to be contained within the IF with no releases to the public. There are no 

dose consequences for either on site workers or the public for these events. The 

consequences of these events have been analyzed and shown to be bounded by the MHA. 

Radiation doses to the public and staff will be within acceptable limits, and the safety and 

health of the staff and public will be adequately protected.
Accident Analyses

13-23

Therefore, the staff finds that the preliminary analysis of irradiation facility fires, as described in 

SHINE PSAR Sections 13a2.1.12.2 and 13a2.2.12.2, is sufficient and meets the applicable 

regulatory requirements and guidance for the issuance of a construction permit in accordance 

with 10 CFR 50.35 and 50.40. Further technical or design information required to complete the 

safety analysis may reasonably be left for later consideration. The staff will confirm that the final 

design conforms to the design basis during the evaluation of SHINE’s FSAR.

13a.4.14 Tritium Purification System (TPS) Design Basis Accident

As described in SHINE PSAR Sections 13a2.1.12.3 and 13a2.2.12.3, “Tritium Purification 

System (TPS) Design Basis Accident,” the TPS contains and processes the tritium that is used 

in the neutron drivers. Tritium is delivered to the SHINE facility in Department of Transportation 

(DOT) approved containers. Those containers are loaded into the TPS glove boxes, which are 

located in the IF. The system purifies and delivers the gas containing the tritium to the 

accelerator target chamber. The TPS has two independent isotope separation subsystems that 

share a common supply and return piping system that supplies tritium to the neutron driver. The 

release of tritium from the TPS can result in radiation doses to workers and the public.

The applicant identified piping failure, equipment malfunctions, and human errors as possible 

initiating events that cause a release of tritium. Important conditions and assumptions that are 

important to the safety of the system are:

• The TPS process equipment is operated through a programmable logic 

controller/process automation controller (PLC/PAC). The process will be performed in 

semi-batch process steps of treating the contaminated flush gas and purifying the 

contaminated tritium gas. The process steps and local operator interfaces will be 

controlled and monitored by the PLC system.

• Two independent TPS glove boxes form a confinement boundary around the two isotope 

separation systems. Double-walled pipe forms a confinement boundary around the TPS 

supply and return tritium piping to and from the neutron drivers.

• The glove box atmosphere is inerted with nitrogen and oxygen levels are monitored.

• The piping to and from the neutron driver accelerator system (NDAS) is double-walled 

and designed to maintain its integrity during normal and accident conditions.

• Leakage of tritium from the system will be into either the double-wall piping or glovebox 

confinement.

• Leakage of tritium from the glove box enclosure or the external piping is detected by the 

RAMS or other leakage detection systems to ensure facility personnel are protected.

• The TPS glove boxes and piping are seismically designed and protected from external 

events by building design.

• Automatic isolation valves are installed in the system to isolate sections of the system to 

minimize system release.
Accident Analysis

13-24

• Tritium is delivered in robust DOT approved containers and transported in engineered 

transport containers, and is only handled inside the TPS glove boxes or a transfer 

confinement.

• TPS piping to and from the NDAS units is normally operated at sub-atmospheric 

pressures.

The applicant considered several possible scenarios including a loss of TPS system integrity 

inside the glove box or double-wall piping, loss of confinement integrity, mishandling or dropping 

of a TPS ambient molecular sieve bed (AMSB) during maintenance, release of tritium during a 

transfer operation, and fire.

A loss of TPS system integrity because of a pipe break in a neutron driver was determined to be 

the limiting event since the only significant tritium inventory that is not in double walled piping or 

an engineered confinement is in the neutron drivers. The TPS has isolation features to mitigate 

large releases of tritium and no active single failure can cause a large release. A pipe break on 

a neutron driver would be expected to release less than 15 percent of the driver tritium inventory 

for all IUs because of automatic isolation valves, but a loss of the entire inventory is assumed 

for this accident. Isolation dampers on the RCA ventilation system will automatically close on 

high radiation signals. The sequence of events for the postulated scenario is as follows:

• A release of the tritium in the neutron driver system directly to the irradiation unit cell.

• A high radiation signal (e.g., loss of vacuum in TPS piping) or other actuation signal 

activates the bubble-tight isolation dampers after approximately one percent of the 

material is released to the RVZ1, and actuates isolation of tritium supply and return 

piping.

• The airborne activity is filtered prior to being released to the environment through the 

RVZ1 system until the bubble-tight dampers are closed.

• Alarms are available locally or in the control room to notify facility personnel of radiation 

leakage due to loss of TPS integrity.

• Facility personnel evacuate the immediate area upon actuation of the radiation area 

monitor alarms.

No credit is given for the confinement of the IU cell for the worker dose calculation and all of the 

activity is assumed to be released to RVZ1. The airborne activity in RVZ1 is released to the 

environment without credit for any decontamination. 

The applicant determined that the dose consequences of the loss of TPS integrity are calculated 

to be within the regulatory limits of 10 CFR Part 20. A TEDE of 2.4 rem is calculated for the 

workers at the facility. This on-site dose is less than the 5 rem regulatory limit specified in 

10 CFR 20.1201. A TEDE of 5.6e-4 rem is calculated for a member of the public at the site 

boundary, and a TEDE of 8.0e-5 rem is calculated at the nearest residence. The off-site doses 

are less than the 0.1 rem regulatory limit specified in 10 CFR 20.1301.

On the basis of its review, the staff has determined that the level of detail provided on TPS 

design basis accident demonstrates an adequate design basis for a preliminary design and 
Accident Analyses

13-25

satisfies the applicable acceptance criteria of the ISG Augmenting NUREG-1537, Part 2, 

Section 13a2, allowing the staff to make the following relevant findings:

(1) The tritium release in this scenario will enter into the gas space of the IU. The tritium 

release rate should be controlled by the mixing of the tritium in the gas space.

(2) The exposure time of workers is assumed to be 10 minutes, which should be 

conservative for workers trained to evacuate in the event of a radiological release.

(3) The applicant adequately considered the consequences of a tritium purification system 

accident. Because the assumptions of the scenario are bounding, the doses 

calculated for this event will be conservative. More realistic assumptions for the 

release fractions would decrease the source term significantly compared to the source 

term assumed for this scenario. The consequences of the IF tritium purification 

system accident have been analyzed and shown to be bounded by the MHA. 

Radiation doses to the public and staff will be within acceptable limits, and the safety 

and health of the staff and public will be adequately protected.

Therefore, the staff finds that the preliminary analysis of the IF tritium purification system 

accident, as described in SHINE PSAR Sections 13a2.1.12.3 and 13a2.2.12.3, is sufficient and 

meets the applicable regulatory requirements and guidance for the issuance of a construction 

permit in accordance with 10 CFR 50.35 and 50.40. Further technical or design information 

required to complete the safety analysis may reasonably be left for later consideration. The 

staff will confirm that the final design conforms to the design basis during the evaluation of 

SHINE’s FSAR.

13a.4.15 Probable Subjects of Technical Specifications

In accordance with 10 CFR 50.34(a)(5), the staff evaluated the sufficiency of the applicant’s 

identification and justification for the selection of those variables, conditions, or other items 

which are determined to be probable subjects of technical specifications supporting the SHINE 

accident analysis, with special attention given to those items which may significantly influence 

the final design.

SHINE PSAR Section 13a2.2.2.7, “Safety Controls,” identifies uranium enrichment and 

concentration as probable subjects of technical specifications to address excess reactivity 

insertion accidents. Section 13a2.2.2.7 also includes procedural controls of start-up as an 

administrative control.

SHINE PSAR Section 13a2.2.8, “Large Undamped Power Oscillation,” lists negative 

temperature and void coefficients, as well as TSV thermal power limits as probable subjects of 

technical specifications required to address large undamped power oscillations.

SHINE PSAR Section 13a2.2.10, “Unintended Exothermic Chemical Reactions Other Than 

Detonation,” identifies uranium enrichment and concentration as probable subjects of technical 

specifications to prevent the effects of PSB interaction events. 

SHINE PSAR Section 13a2.2.12.1, “Inadvertent Exposure to Neutrons from the Neutron Driver,” 

identifies the use of accelerator audible/visual warnings as a probable administrative technical 

specification to prevent an inadvertent exposure to neutrons from the accelerator.
Accident Analysis

13-26

SHINE PSAR Section 13a2.2.12.2, “Irradiation Facility Fire Event,” identifies limited tritium 

inventory based on TPS fixed glovebox volume and deuterium source vessel integrity program 

as probable administrative technical specifications to prevent irradiation facility fire events.

SHINE PSAR Section 13a2.2.12.3, “Tritium Purification System Design Basis Accident,” lists 

engineered transport enclosures or containers and TPS system sampling, inspection, testing 

and operating procedures as probable administrative technical specifications to prevent a TPS 

design basis accident.

Based on the information provided in Section 13a2.2 of the SHINE PSAR, the staff finds that 

identification and justification of the proposed technical specifications is sufficient and meets the 

applicable regulatory requirements for the issuance of a construction permit in accordance with 

10 CFR 50.35. A detailed evaluation of technical specifications, including LCOs and 

surveillance requirements, will be performed during the review of SHINE’s operating license 

application.

13a.5 Summary and Conclusions

The staff evaluated descriptions and discussions of SHINE’s IF accident analysis, including 

probable subjects of technical specifications, as described in SHINE PSAR Section 13a2 and 

supplemented by the applicant’s responses to RAIs, and finds that the preliminary accident 

analysis, including the principal design criteria; design bases; information relative to materials of 

construction, general arrangement, and approximate dimensions; and preliminary analysis and 

evaluation of the design and performance of structures, systems, and components of the facility: 

(1) provides reasonable assurance that the final design will conform to the design basis, (2) 

includes an adequate margin of safety, (3) structures, systems, and components adequately 

provide for the prevention of accidents and the mitigation of consequences of accidents, and (4) 

meets all applicable regulatory requirements and acceptance criteria in or referenced in ISG 

Augmenting NUREG-1537.

The staff further notes that the applicant has proposed and analyzed a set of accidents that 

should be representative of the possible range of events that may happen in an operating 

facility. The proposed set was the result of a detailed analysis of the facility design and 

identification of potential initiating events that can test possible vulnerabilities in the facility 

design. The analyzed set of accidents provides insights into the challenges to the safety 

systems and defense in depth features of the facility and consider how the potential accidents 

might be prevented or mitigated by administrative controls, engineered safety systems, and 

trained personnel actions.

SHINE used International Commission on Radiation Protection (ICRP) Publication 30, “Limits 

for Intakes of Radionuclides by Workers,” (ICRP 30) to calculate dose to members of the public 

in the preliminary accident analysis because ICRP 30 forms part of the basis for 10 CFR 

Part 20, and there is no regulatory requirement to use any guidance other than ICRP 30. 

However, SHINE acknowledges that ICRP Publication 72, “Age-dependent Doses to Members 

of the Public from Intake of Radionuclides: Part 5 Compilation of Ingestion and Inhalation Dose 

Coefficients,” (ICRP 72) provides dose coefficients based on newer bio-kinetic models and data 

than ICRP 30. Therefore, as described in response to RAI 13a2.2-5 (Reference 27), SHINE will 

update the accident analysis calculations to use dose conversion factors (DCFs) from ICRP 72 

and will calculate dose effects to ensure that the dose limits in 10 CFR 20.1301 are met. The 

staff is tracking this as a regulatory commitment in Appendix A of this SER.
Accident Analyses

13-27

The proposed features of the design, including the engineered safety features keep the 

radiation doses below acceptable limits and adequately protect the workers and the public for all 

proposed accidents. The safety systems are single failure proof and follow the defense in depth 

philosophy. The applicant has also proposed an MHA that uses conservative assumptions. 

The calculated dose release consequences of the MHA bound all other accidents. The 

proposed preliminary features of the design including administrative controls, engineered safety

features, and trained personnel actions keep the radiation doses below acceptable limits and 

adequately protect the workers and the public for the MHA. Therefore, the proposed preliminary 

accident analysis of the IU and the calculated consequences show that the design, including the 

engineered safety features adequately protect workers and the public.

On the basis of these findings, the staff has made the following conclusions for the issuance of 

a construction permit in accordance with 10 CFR 50.35 and 50.40:

(1) SHINE has described the proposed design of the systems supporting the accident 

analysis, including, but not limited to, the principal architectural and engineering criteria 

for the design, and has identified the major features or components incorporated 

therein for the protection of the health and safety of the public.

(2) Further technical or design information required to complete the safety analysis of the 

cooling systems may reasonably be left for later consideration in the FSAR.

(3) There is reasonable assurance that, taking into consideration the site criteria contained 

in 10 CFR Part 100, the proposed facility can be constructed and operated at the 

proposed location without undue risk to the health and safety of the public.

(4) There is reasonable assurance: (i) that the construction of the SHINE facility will not 

endanger the health and safety of the public, and (ii) that construction activities can be 

conducted in compliance with the Commission’s regulations.

(5) The issuance of a permit for the construction of the facility would not be inimical to the 

common defense and security or to the health and safety of the public.

13b Radioisotope Production Facility Accident Analysis

Section 13b, “Radioisotope Production Facility Accident Analysis,” provides an evaluation of the 

preliminary accident analysis of SHINE’s RPF as presented in PSAR Section 13b, 

“Radioisotope Production Facility Accident Analysis,” within which, SHINE describes 

accident-initiating events and scenarios, as well as the accident analysis and determination of 

consequences.

13b.1 Areas of Review

The staff reviewed SHINE PSAR Section 13b against applicable regulatory requirements using 

appropriate regulatory guidance and standards to assess the sufficiency of the preliminary 

accident analysis. As part of this review, the staff evaluated descriptions and discussions of 

SHINE’s accident analysis, with attention to design and operating characteristics, unusual or 

unique design features, and principal safety considerations. The preliminary accident analysis 

was evaluated to ensure the sufficiency of principal design criteria; design bases; and general 

information relative to materials of construction, arrangement of structures and components, 

and approximate dimensions, as needed, sufficient to provide reasonable assurance that the 
Accident Analysis

13-28

final design will conform to the design basis. In addition, the staff reviewed SHINE’s 

identification and justification for the selection of those variables, conditions, or other items that 

are important to safety and that are determined to be probable subjects of technical 

specifications for the facility. Structures, systems, and components were also evaluated to 

ensure that they would adequately provide for the prevention of accidents and the mitigation of 

consequences of accidents. The staff considered the preliminary analysis and evaluation of the 

design and performance of SSCs of the SHINE facility, including those SSCs shared by both the 

IF and RPF, with the objective of assessing the risk to public health and safety resulting from 

operation of the facility.

Areas of review for this section included accident analysis methodology, accidents with 

radiological consequences, and accidents with hazardous chemicals. Within these areas of 

review, the staff assessed processes conducted outside the IF; accident initiating events; the 

maximum hypothetical accident; loss of containment; external events; critical equipment 

malfunction; inadvertent nuclear criticalities; RPF fire; and chemical accident descriptions, 

mitigated and unmitigated consequences, and safety controls.

13b.2 Summary of Application

The accident analysis for the Radioisotope Production Facility (RPF) establishes safety limits 

and designates safety controls for facility operations in the RPF. A technical basis for control of 

those limits is provided in the PSAR and in supporting information for the integrated safety 

analysis. Some portion of this technical basis is expected to be included in technical 

specifications. The accidents analyzed in this chapter also support the establishment of the 

design basis limits for the SSCs in the RPF processes. The RPF design has design features 

and analysis assumptions that are important for understanding the bases of the accident 

analysis as it applies to the design of the facility. The applicant has identified, through a 

systematic process, a variety of event types that are expected to be prevented or mitigated to 

acceptable limits for the credible accidents related to the RPF. All accident scenarios and 

analyses for the construction permit are based on the preliminary design of the facility and are 

considered preliminary from an operating licensing and final design standpoint.

SHINE PSAR Section 13b describes accident analysis methodology, accidents with radiological 

consequences, and accidents with hazardous chemicals for the SHINE RPF. The application 

provides details on processes conducted outside the IF; accident initiating events; the maximum 

hypothetical accident; loss of containment; external events; critical equipment malfunction; 

inadvertent nuclear criticalities; RPF fire; and chemical accident descriptions, consequences, 

controls, and surveillance requirements. SHINE PSAR Section 13b.1.2 and Table 13b.1-1-4, 

“Potential Accident Sequences,” which was provided in response to RAI 13b.1-1 

(Reference 21), discuss initiating events that could accidentally release fission products from 

irradiated fuel while in process, in storage, or while being transferred within the facility. 

Section 13b.2.5 of the PSAR discusses the potential for a criticality incident with un-irradiated 

SNM. An accidental criticality is shown to be highly unlikely, as the facility has been designed 

with passive engineering design features and other safety related controls to prevent criticality 

and assure that processes remain subcritical. Additionally, administrative controls and 

safety-related (SR) SSCs provide control on enrichments and target solution uranium 

concentration to further prevent inadvertent criticality. Section 13b.2.5 identifies areas within the 

RPF where an inadvertent criticality is possible and discusses controls that are used to reduce 

the likelihood of an inadvertent criticality. Additional criticality safety analysis discussion and 

review is in Section 6b of this SER.
Accident Analyses

13-29

The RPF design basis is supported by information provided in SHINE PSAR Section 13b 

through discussions related to the use of Integrated Safety Analysis (ISA) methodology, 

determination of anticipated events, demonstration of acceptable risk, and the determination 

and designation of the safety controls needed for the risk demonstration. The analysis 

performed by the applicant considers the radiological consequences, chemical consequences, 

fire analysis, and criticality status of credible accidents in the radioisotope production facility. 

The applicant provided the following basis for the identification and evaluation of accident 

scenarios in the RPF:

• Hazard and operability studies (HAZOPS) and preliminary design hazard analyses 

(PHA) performed using guidance consistent with NUREG-1520 (Reference 60).

• The list of accidents identified in the Final Interim Staff Guidance (ISG) Augmenting 

NUREG-1537.

• Experience of the hazard analysis team.

• Current preliminary design and design basis evaluations in the preliminary safety 

analysis report (PSAR) for the processes in the radioisotope production facility.

• The determination of safety controls needed to prevent or mitigate accidents.

13b.3 Regulatory Basis and Acceptance Criteria

The staff reviewed SHINE PSAR Section 13b against applicable regulatory requirements, 

regulatory guidance, and standards, to assess the sufficiency of the preliminary accident 

analysis for the issuance of a construction permit. In accordance with paragraph (a) of 

10 CF 50.35, “Issuance of Construction Permits,” a construction permit authorizing SHINE to 

proceed with construction may be issued once the following findings have been made:

(1) SHINE has described the proposed design of the facility, including, but not limited to, 

the principal architectural and engineering criteria for the design, and has identified the 

major features or components incorporated therein for the protection of the health and 

safety of the public. 

(2) Such further technical or design information, as may be required to complete the 

safety analysis, and which can reasonably be left for later consideration, will be 

supplied in the FSAR.

(3) Safety features or components, if any, which require research and development have 

been described by SHINE and a research and development program will be conducted 

that is reasonably designed to resolve any safety questions associated with such 

features or components. 

(4) On the basis of the foregoing, there is reasonable assurance that: (i) such safety 

questions will be satisfactorily resolved at or before the latest date stated in the 

application for completion of construction of the proposed facility, and (ii) taking into 

consideration the site criteria contained in 10 CFR Part 100, the proposed facility can 

be constructed and operated at the proposed location without undue risk to the health 

and safety of the public.
Accident Analysis

13-30

With respect to the last of these findings, the staff notes that the requirements of 

10 CFR Part 100 are specific to nuclear power reactors, and therefore not applicable to the 

SHINE facility. However, the staff evaluated SHINE’s site specific conditions using site criteria 

similar to 10 CFR Part 100, by using the guidance in NUREG-1537. The staff’s review 

evaluated the geography and demography of the site; nearby industrial, transportation, and 

military facilities; site meteorology; site hydrology; and site geology, seismology, and 

geotechnical engineering to ensure that issuance of the construction permit will not be inimical 

to public health and safety.

The staff’s evaluation of the preliminary accident analysis does not constitute approval of the 

safety of any design feature or specification. Such approval will be made following the 

evaluation of the final design of the SHINE facility as described in the FSAR as part of SHINE’s 

operating license application.

13b.3.1 Applicable Regulatory Requirements

The applicable regulatory requirements for the evaluation of SHINE’s preliminary accident 

analysis are as follows: 

• 10 CFR 50.34, “Contents of applications; technical information,” paragraph (a),

“Preliminary safety analysis report.”

• 50.40, “Common Standards.”

• 10 CFR 20.1201, “Occupational dose limits for adults.”

• 10 CFR 20.1301, “Dose limits for individual members of the public.”

13b.3.2 Regulatory Guidance and Acceptance Criteria

In applying guidance and acceptance criteria, the staff used its judgment as to which 

acceptance criteria were relevant to SHINE’s proposed facility, as much of this guidance was 

originally developed for nuclear reactors. Given the similarities in SHINE’s proposed facility and 

non-power research reactors, the staff used established guidance documents and the 

Commission’s regulations to determine the acceptance criteria for demonstrating compliance 

with 10 CFR regulatory requirements. For example, the staff used: 

• NUREG-1537, Part 1.

• NUREG-1537, Part 2.

• Final ISG Augmenting NUREG-1537, Part 1.

• Final ISG Augmenting NUREG-1537, Part 2.

As stated in the ISG Augmenting NUREG-1537, the staff determined that certain guidance 

originally developed for heterogeneous non-power research and test reactors is applicable to 

aqueous homogenous facilities and production facilities. SHINE used this guidance to inform 

the design of its facility and prepare its PSAR. The staff’s use of reactor-based guidance in its 

evaluation of the SHINE PSAR is consistent with the ISG Augmenting NUREG-1537.

As appropriate, additional guidance (e.g., NRC regulatory guides, IEEE standards, ANSI/ANS 

standards) has been used in the staff’s review of SHINE’s PSAR. The use of additional 
Accident Analyses

13-31

guidance is based on the technical judgment of the reviewer, as well as references in 

NUREG-1537, Parts 1 and 2; the ISG Augmenting NUREG-1537, Parts 1 and 2; and the SHINE 

PSAR. Additional guidance documents used to evaluate SHINE’s PSAR are provided as 

references in Appendix B of this SER.

The staff has determined that the use of Integrated Safety Analysis (ISA) methodologies as 

described in 10 CFR Part 70 and NUREG-1520, “Standard Review Plan for the Review of a 

License Application for a Fuel Cycle Facility” (Reference 60), application of the radiological and 

chemical consequence and likelihood criteria contained in the performance requirements of 

10 CFR 70.61, and establishment of management measures are an acceptable way of 

demonstrating adequate safety for the radioisotope production facility. Applicants are free to 

propose alternate accident analysis methodologies, to propose alternate radiological and 

chemical consequence and likelihood criteria, to propose alternate safety features, and to 

propose alternate methods of assuring the availability and reliability of the safety features.

As used in Section 13b and elsewhere in this SER, the term “performance requirements” is not 

intended to suggest that 10 CFR Part 50 licensees are required to comply with the performance 

requirements found in 10 CFR 70.61, only that their use as accident consequence and 

likelihood criteria for the SHINE RPF would be found acceptable by NRC staff. Alternate 

accident consequence and likelihood criteria 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 to minimize 

danger to life or property.

13b.4 Review Procedures, Technical Evaluation, and Evaluation Findings

The staff evaluated the technical information presented in SHINE PSAR Section 13b, as 

supplemented by the applicant’s responses to RAIs, to assess the sufficiency of the preliminary 

design and performance of SHINE’s accident analysis in the RPF for the issuance of a 

construction permit, in accordance with 10 CFR 50.35(a). The sufficiency of the SHINE 

preliminary accident analysis is determined by ensuring the design and performance meet 

applicable regulatory requirements, guidance, and acceptance criteria, as discussed in Section 

13b.3, “Regulatory Basis and Acceptance Criteria,” of this SER. While the technical evaluation 

of preliminary accident analysis provided in this section is specific to the SHINE RPF, the staff’s 

review considers the interface of accident scenarios between the IF and RPF as part of a 

comprehensive technical evaluation. The results of this technical evaluation are summarized in 

SER Section 13b.5, “Summary and Conclusions.”

For the purposes of issuing a construction permit, the preliminary accident analysis may be 

adequately described at a conceptual level. The staff evaluated the sufficiency of the 

preliminary accident analysis based on the applicant’s design methodology and ability to provide 

reasonable assurance that the final design will conform to the design bases with adequate 

margin for safety. As such, the staff’s evaluation of the preliminary accident analysis does not 

constitute approval of the safety of any design feature or specification. Such approval will be 

made following the evaluation of the final design of the SHINE facility, as described in the 

FSAR, as part of SHINE’s operating license application.

For SER Sections 13b.4.1 through 13b.4.10, the staff evaluated the sufficiency of the 

preliminary identification, analysis, and determination of consequences of accident-initiating 

events and scenarios, as described in SHINE PSAR Sections 13b.1, “Radioisotope Production 
Accident Analysis

13-32

Facility Accident Analysis,” and 13b.2, “Analyses of Accidents with Radiological 

Consequences,” in part, by reviewing the processes conducted outside of the irradiation facility, 

accident initiating events, maximum hypothetical accident, loss of containment, external events, 

loss of normal electric power, mishandling or malfunction of equipment, inadvertent nuclear 

criticality in the RPF, and RPF fire, using the guidance and acceptance criteria from Section 

13b.1, “Radioisotope Production Facility Accident Analysis Methodology,” of the ISG 

Augmenting NUREG-1537, Parts 1 and 2.

For SER Sections 13b.4.1 through 13b.4.10, consistent with the review procedures of the ISG 

Augmenting NUREG-1537, Part 2, Section 13b.1, the staff reviewed SHINE’s accident 

methodology and analysis and followed the sequence of events in each accident scenario from 

initiation to stabilization. The staff evaluated the maximum hypothetical accident; credible 

accidents; instruments, controls and automatic protective systems assumed to be operating 

normally before an initiating event; the identification of single malfunctions; the discussion of 

sequence of events and components and systems damaged during the accident scenario; 

mathematical models and analytical methods employed; radiation source term; and that 

potential radiation consequences to the facility staff and public were presented and compared 

with acceptable limits.

13b.4.1 Processes Conducted Outside of the Irradiation Facility

The processes that occur within the radioisotope production facility were evaluated by the 

applicant through the performance of an Integrated Safety Analysis (ISA) and expected 

generation of an ISA Summary. As part of the ISA analysis, the applicant evaluated the 

hazards associated with the processes in the radioisotope production facility. Section 13b.1.1 of 

the PSAR (Reference 13) contains information that provides assurance that all potential 

accidents at the RPF that could reach unmitigated and uncontrolled consequences of concern 

have been considered and their consequences adequately evaluated. SHINE considered 

postulated accidents in the categories identified below. 

A summary of the evaluations for the radioisotope production facility falls into the following 

categories:

• Operations with Special Nuclear Material (SNM)

­ Irradiated target solution processing for radioisotope extraction

­ Irradiated target solution processing for reuse or for waste disposal

­ Processing with unirradiated SNM

• Radiochemical operations

• Operations with hazardous chemicals

In the course of reviewing SHINE’s accident methodology, the staff determined that additional 

information was necessary to evaluate the adequacy of SHINE’s methodology for determining 

the sequence of events in an accident scenario, including the qualifications of the ISA team. 

Therefore, RAI 13b.1-3 (Reference 16) was issued, in part, to satisfy the requirements 

discussed in the ISG Augmenting NUREG-1537, Part 2, Section 13b.1.2, “Accident Initiating 

Events,” which states that information in the PSAR should allow the reviewer to follow the 

sequence of events in the accident scenario from initiation to a stabilized condition. In response 

to this RAI (Reference 25), the applicant provided information that describes the ISA team that 

performed the preliminary ISA analysis of the radioisotope production facility. The staff 
Accident Analyses

13-33

reviewed the makeup of the ISA team provided and the applicable experience and expertise of 

the ISA team members. Team members were qualified in the areas of chemical safety, 

criticality safety, fire safety, and radiological safety, and multiple members were qualified, 

trained ISA team leaders, as required. The composition of the ISA team makeup and 

qualifications was consistent with the guidance of NUREG-1520 (Reference 60) and followed 

the requirements of 10 CFR 70.62(c)(2). The staff review finds that the team performing the 

preliminary ISA analysis, as described in response to RAI 13b.1-3 (Reference 25), to be 

acceptable as it contained members with technical expertise, ISA methodology 

knowledgeability, and operationally experienced personnel.

The applicant used two types of hazard assessment methods to evaluate the hazards of the 

RPF processes in the facility. These methods are a HAZOPS, and a PHA. A HAZOPS focuses 

on the evaluation of potential process upsets or deviations, which leads to identification of 

potential accidents and scenarios of concern which serve as input to the PHA and the 

identification of process safety controls. The PHA focuses on evaluating facility and external 

events that are common to the radioisotope production facility.

For the ISA methodology, the applicant provided likelihood and initiating event data for its 

preliminary ISA evaluations of the radioisotope production facility design. SHINE’s radiological 

consequence analysis utilized requirements similar to the requirements of 10 CFR 70.61. For 

the radiological events, the applicant uses 10 CFR Part 20 dose criteria rather than the 10 

CFR 70.61 performance criteria. Given that the 10 CFR Part 20 criteria are more conservative 

than the 10 CFR 70.61 requirements, the staff finds that alternate approach acceptable. 

Consistent with the ISG guidance for chemical performance criteria, the applicant followed 

10 CFR 70.61 limits. SHINE performed a PHA and HAZOPS on processes conducted outside 

the irradiation facility, and will provide the results of these evaluations in an ISA Summary for 

the RPF to be submitted as part of their application for an operating license. 

However, in the course of reviewing SHINE’s ISA process, the NRC staff determined that 

additional information was needed to assess the adequacy of SHINE’s ISA process to its 

accident analysis. Therefore, in RAIs 13b.1-1 and 13b.1-2 (Reference 14), the staff requested 

that SHINE provide additional information on its accident sequences to understand how an ISA 

was performed for each process or process segment in the RPF. (See ISG Augmenting 

NUREG-1537, Part 2, Section 13b.1, “Radioisotope Production Facility Accident Analysis 

Methodology,” which states that “an integrated safety analysis should be performed for each 

process or process segment” in the RPF). In response to these RAIs (Reference 21), and in a 

revision to PSAR Chapter 13, (Reference 61), SHINE provided a preliminary ISA Summary 

based on the current design of the facility that identified accident sequences with high or 

intermediate consequences, and designated safety-related structures systems and components 

(SR-SSCs) to prevent or mitigate the credible hazards to acceptable consequences. The 

majority of these SR-SSCs are passive and active engineered controls that will be constructed 

or installed during the construction permit phase of the SHINE project. SHINE PSAR Chapter 3, 

as supplemented by responses to RAIs, provided standards and reliability criteria for the 

passive and active engineered controls. While administrative controls requiring the 

performance of operator actions were briefly described in the responses to RAIs 13b.1-1 and 

13b.1-2, the management measures needed to justify their availability and reliability for 

performing their safety functions, as needed, were not described in detail. The staff finds that 

the preliminary ISA Summary provided by SHINE satisfies the requirements of the ISG 

Augmenting NUREG-1537, Part 2, Section 13b.1, and demonstrates an adequate design basis 

for a preliminary design. The staff will confirm that additional analyses and details on the ISA 
Accident Analysis

13-34

process and specific technical topics, such as on administrative controls and supporting 

management measures, conforms to this design basis during the evaluation of SHINE’s FSAR.

On the basis of its review, the staff has determined that the level of detail provided on processes 

conducted outside of the irradiation facility demonstrates an adequate design basis for a 

preliminary design and satisfies the applicable acceptance criteria of the ISG Augmenting 

NUREG-1537, Part 2, Section 13b.1, allowing the staff to make the following relevant findings: 

(1) The use of ISA methodologies as described in 10 CFR Part 70 and ISG Augmenting 

NUREG-1537, application of the radiological and chemical consequence and likelihood 

criteria contained in the performance requirements of 10 CFR 70.61 and 

10 CFR Part 20, and establishment of management measures demonstrate adequate 

safety for the radioisotope production facility. 

(2) The staff also finds that the definitions of highly unlikely, unlikely and credible are 

consistent with the guidance in NUREG-1520 and are acceptable for use in the ISA 

analysis. 

(3) The preliminary ISA performed by the applicant provides the basis to establish that the 

design of the facility including the associated structures, systems, and components 

can adequately assure that acceptable risk to the workers, public and the environment 

can be established and maintained. The evaluations performed by the applicant have 

resulted in the conditions needed to designate passive and active engineered safety 

features needed for the safe operation of this section of the facility and for the 

processes performed in this section of the facility.

(4) Evaluations performed by the applicant will ensure that all nuclear processes will be 

subcritical during normal and credible abnormal operating conditions and that high 

consequence accidents are controlled to be highly unlikely, and that intermediate 

consequence accidents are controlled to be unlikely.

Therefore, the staff finds that the preliminary analysis of processes conducted outside of the 

irradiation facility, as described in SHINE PSAR Sections 13b.1.1, and supplemented by the 

applicant’s responses to RAIs, is sufficient and meets the applicable regulatory requirements 

and guidance for the issuance of a construction permit in accordance with 10 CFR 50.35 and 

50.40. Further technical or design information required to complete the safety analysis may 

reasonably be left for later consideration. The staff will confirm that the final design conforms to 

the design basis during the evaluation of SHINE’s FSAR.

13b.4.2 Accident Initiating Events

The staff reviewed the two types of hazard assessment methods the applicant selected to 

evaluate the hazards of the facility by evaluating specific accidents scenarios of various 

technical types. These methods are a HAZOPS and a PHA. The HAZOPS focused on the 

evaluation of potential process upsets or deviations, which leads to identification of potential 

initiating events (IEs) and scenarios of concern and served as input to the PHA and the 

identification of process controls. The PHA focused on evaluating facility and external events 

that are common to the IF and RPF. These methods are typical methods used for the 

evaluation of hazards in fuel cycle facilities. The staff review included evaluation of the 

completeness of the hazards evaluated for the radioisotope production facility, as well as the 
Accident Analyses

13-35

determination of the preliminary likelihoods and consequences for each accident sequence 

event.

For the RPF, SHINE also analyzed an accident scenario with consequences exceeding all 

credible accidents, called the Maximum Hypothetical Accident (MHA). In the RPF, the MHA 

was identified as a release of inventory stored in the Noble Gas Removal System (NGRS) 

tanks, resulting in a maximum release of radiological material to the workers and individual 

members of the public.

The RPF accident analyses included all processes involving greater than critical mass (as 

defined in 10 CFR 70.4) quantities of SNM. The performance criteria in 10 CFR 70.61, 

“Performance Requirements,” categorize accidents according to severity of consequences. 

These performance criteria require that high-consequence accidents to be rendered highly 

unlikely to occur through the application of in-depth preventive and mitigative measures. Other 

accidents with less than high consequences, as defined in 10 CFR 70.61, require fewer or 

less-strict protective measures. 

SHINE’s RPF accident analyses identified structures, systems, components that SHINE has 

designated as SR-SSCs. SHINE intends to include the SR-SSCs in operating license technical 

specifications and apply the management measures needed to assure that the SSC’s 

availability and reliability is well established and maintained.

The preliminary accident analyses for the operations with special nuclear material (SNM) in the 

radioisotope production facility included the following types of events:

• MHA

• External events

• Critical equipment malfunction

• RPF fire

• Chemical accidents.

In the course of reviewing SHINE’s RPF accident analysis, the staff determined that additional 

information was necessary to evaluate the adequacy of SHINE’s identification and analysis of 

accident sequences, from the initiating events through the sequence’s mitigated consequences. 

Therefore, RAI 13b.1-3 (Reference 16) was issued, in part, to request that SHINE provide 

detailed accident sequence descriptions for at least four of the sequences, from the initiating 

events through the sequence’s mitigating consequences. This information was necessary to 

understand how the PSAR allows the staff to follow the sequence of events in the accident 

scenario from initiation to a stabilized condition. (See NUREG-1537, Part 2, Section 13b.1.2, 

“Accident Initiating Events”). In response to this RAI (Reference 25), the applicant 

systematically analyzed and evaluated events in each category and identified the limiting event 

for each type for detailed quantitative analysis of the possible consequences. The limiting event 

in each category had consequences that exceed all others in that category. The applicant 

addressed the likelihood of occurrence for both the initiating events and the safety control 

failures in a qualitative manner consistent with the proposed methodology provided in the 

response to RAI 13b.1-3. Quantitative analysis of probability is not required and was not 

provided other than frequency of occurrence for certain external events. NRC staff reviewed 

SHINE’s systematic analysis and discussion of credible accidents for determining the general 

types of accident sequences in each category, and finds that the response to RAI 13b.1-3 

satisfies the requirements discussed in the ISG Augmenting NUREG-1537, Part 2, 
Accident Analysis

13-36

Section 13b.1.1 and demonstrates an adequate design basis for a preliminary design. 

Demonstration of meeting the risk-informed performance criteria was supported by the use of 

tables from NUREG-1520 (Reference 60) that provided initiating event and failure likelihood 

scoring data, as well as a matrix for evaluating acceptability of the overall accident sequence 

risk. The staff will confirm that the final design conforms to this design basis during the 

evaluation of SHINE’s FSAR. 

On the basis of its review, the staff has determined that the level of detail provided on processes 

conducted outside of the irradiation facility demonstrates an adequate design basis for a 

preliminary design and satisfies the applicable acceptance criteria of the ISG Augmenting 

NUREG-1537, Part 2, Section 13b.1, allowing the staff to make the following relevant findings: 

(1) SHINE has implemented an adequate preliminary safety program similar to the safety 

program in 10 CFR 70.62, including accident analysis and the future application of 

management measures as described in Chapter 12 of the PSAR, “Conduct of 

Operations” (Reference 13). 

(2) There is reasonable assurance that SHINE has addressed all significant credible 

accidents involving internal facility processes, abnormal events, and process 

deviations and credible external events that could result in serious adverse 

consequences to workers, the facility, the public, and the environment.

(3) SHINE has identified designated engineered and administrative safety features

necessary to provide preventive or mitigative measures that give reasonable 

assurance that the facility will operate in compliance with the performance 

requirements proposed by the applicant. 

(4) For the RPF, the results of the accident analysis demonstrate, in a preliminary manner, 

adequate safety by meeting the performance requirements proposed by the applicant 

for demonstrating acceptable risk. 

(5) Information in the PSAR and in responses to staff RAIs allowed NRC staff to review 

the sequence of events in the accident scenario from initiation to a stabilized condition.

(6) NRC staff has reasonable assurance that all credible accidents at the RPF were 

considered and evaluated during the preliminary design stage. The demonstrations of 

the risk associated with credible accidents were shown to be adequate to prevent the 

release of radioactive materials, in amounts exceeding regulatory limits, to 

uncontrolled areas as a result of credible accidents.

(7) The applicant has considered the consequences to the public and the workers for all 

credible chemical accidents at the radioisotope production facility that reach the 

intermediate or high consequence thresholds as defined by the applicant consistent 

with the guidance in the ISG. 

Therefore, the staff finds that the preliminary analysis of accident initiating events, as described 

in SHINE PSAR Sections 13b.1.2, and supplemented by the applicant’s responses to RAIs, is 

sufficient and meets the applicable regulatory requirements and guidance for the issuance of a 

construction permit in accordance with 10 CFR 50.35 and 50.40. The staff will confirm that the 

final design conforms to the design basis during the evaluation of SHINE’s FSAR.
Accident Analyses

13-37

13b.4.3 Maximum Hypothetical Accident

As described in SHINE PSAR Sections 13a2.1.1, “Maximum Hypothetical Accident,” and 

13a2.2.1, “Target Solution Release into the IU Cell,” SHINE considered an MHA for the IF as 

well as the RPF. While an evaluation of the MHA for the IF is provided in SER Section 13a.4.1, 

the RPF postulated MHA, as described in SHINE PSAR 13b.2.1, “Maximum Hypothetical 

Accident in the RPF,” provides the bounding consequences to the public and is therefore 

considered the MHA for the SHINE facility. An evaluation of the RPF postulated MHA is 

provided below.

For the RPF, SHINE analyzed an accident scenario with consequences exceeding all credible 

accidents, called the Maximum Hypothetical Accident (MHA). In the RPF, the MHA was 

identified as a release of inventory stored in the Noble Gas Removal System (NGRS) tanks, 

resulting in a maximum release of radiological material to the workers and individual members 

of the public.

The applicant demonstrated that the dose consequences of the MHA are calculated to be within 

the regulatory limits of 10 CFR Part 20. A TEDE of 3.59 rem calculated for the workers at the 

facility. This on-site dose is less than the 5 rem regulatory limit specified in 10 CFR 20.1201. A 

TEDE of 0.0820 rem is calculated for a member of the public at the site boundary, and a TEDE 

of 0.0115 rem is calculated at the nearest residence. The off-site doses are less than the 0.1 

rem regulatory limit specified in 10 CFR 20.1301. 

Because the assumptions of the scenario are bounding, the doses calculated will likely not be 

exceeded by any accident considered credible. The applicant has also examined more realistic 

assumptions about operating time and release fractions that decreased the source term 

significantly compared to the one calculated for the MHA. The staff finds that for the MHA, the 

health and safety of the facility staff and the public are protected. 

On the basis of its review, the staff has determined that the level of detail provided on SHINE’s 

MHA demonstrates an adequate design basis for a preliminary design and satisfies the 

applicable acceptance criteria of the ISG Augmenting NUREG-1537, Part 2, Section 13b.1, 

allowing the staff to make the following relevant findings: 

(1) The exposure time of workers is assumed to be 10 minutes, which is conservative for 

workers trained to evacuate in the event of a radiological release.

(2) For the preliminary design, the confinement and engineered safety features are 

assumed to function as designed and radioactive material is held up temporarily in the 

facility and then released under controlled conditions. Realistic but conservative 

methods are used to compute potential doses and dose commitments to the public in 

uncontrolled areas and to compute external radiation doses and dose commitments 

resulting from inhalation by the facility staff. Methods of calculating doses from 

inhalation or ingestion (or both) and direct exposure to gamma rays from dispersing 

plumes of airborne radioactive material are applicable and no less conservative than 

those developed in Chapter 11 of the PSAR.

(3) The applicant has considered the consequences to the public and the facility staff of all 

credible accidents at the radioisotope production facility. An MHA, which, for this 

facility, is a release of inventory stored in the NGRS tanks with consequences greater 

than any credible accident, has been analyzed. The MHA, however, is not considered 
Accident Analysis

13-38

to be a credible event for this facility. The RPF MHA serves as a bounding accident 

analysis for the entire SHINE facility.

(4) Because the assumptions of the scenario are bounding, the doses calculated will likely 

not be exceeded by any accident considered credible. The applicant has also 

examined more realistic assumptions about operating time and release fractions that 

decreased the source term significantly compared to the one calculated for the MHA. 

Thus, even for the RPF MHA, whose consequences bound all credible accidents 

possible at the facility, the health and safety of the facility staff and the public are 

protected.

Therefore, the staff finds that the preliminary analysis of the MHA, as described in SHINE PSAR 

Section 13b.2.1, is sufficient and meets the applicable regulatory requirements and guidance for

the issuance of a construction permit in accordance with 10 CFR 50.35. Further technical or 

design information required to complete the safety analysis may reasonably be left for later 

consideration. The staff will confirm that the final design conforms to the design basis during 

the evaluation of SHINE’s FSAR.

13b.4.4 Loss of Containment

SHINE PSAR Sections 6a2.2.2, and 6b.2.2, “Containment,” state, in part, that “[t]he SHINE 

facility does not employ a containment feature. Due to the low temperature and power level of 

facility operations, the safety analysis demonstrates that confinement features are adequate to 

mitigate potential accidents.” In PSAR Section 13b.2.2, “Loss of Containment,” SHINE further 

states that “[t]he use of confinements as an ESF [engineered safety feature] in the RPF is 

described in [PSAR] Section 6b.2.1. Control of the target solution is performed by piping 

systems and tanks. A loss of the integrity of piping systems or tanks containing target solution 

within the RPF is addressed in [PSAR] Subsection 13b.2.4.”

On the basis of its review, the staff has determined that the SHINE confinement features are 

adequate to mitigate potential accidents and a containment feature is not necessary. SHINE 

demonstrates an adequate design basis for a preliminary design and satisfies the applicable 

acceptance criteria of the ISG Augmenting NUREG-1537, Part 2, Section 13b.1.

Therefore, the staff finds that the loss of containment event, as described in SHINE PSAR 

Section 13b.2.2, is sufficient and meets the applicable regulatory requirements and guidance for

the issuance of a construction permit in accordance with 10 CFR 50.35 and 50.40. The staff will 

confirm that the final design conforms to the design basis during the evaluation of SHINE’s 

FSAR.

13b.4.5 Loss of Normal Electric Power

SHINE PSAR Sections 13b.2.1 and 13b.2.4 discuss the events that could result from the 

sudden loss of normal electrical power. As stated, in part, in SHINE PSAR Section 13b.2.4, 

“[t]he isolation dampers are of a fail-safe design, and close on...a loss of power. The total 

release to RVZ1 through the bubble-tight isolation dampers during the accident is assumed to 

be no more than 10 percent of the airborne activity in the noble gas storage cell based on 

design characteristics of the dampers and the response of the RAMs.”

On the basis of its review, the staff has determined that the level of detail provided on SHINE’s 

loss of normal electrical power demonstrates an adequate design basis for a preliminary design 
Accident Analyses

13-39

and satisfies the applicable acceptance criteria of the ISG Augmenting NUREG-1537, Part 2, 

Section 13b.1, allowing the staff to make the following relevant findings: 

(1) All SR-SSCs are returned to a safe condition in a de-energized state. Any requirement 

for emergency cooling or ventilation functions is provided as intended in the facility 

design.

(2) The loss of normal electrical power will not result in an unsafe condition for either the 

facility staff or members of the public in uncontrolled areas. Chapter 8 of the PSAR 

describes emergency power to the facility. The emergency supply will power the 

safety-related equipment and systems required to operate after the loss of normal 

power.

Therefore, the staff finds that the loss of normal electrical power event, as described in SHINE 

PSAR Sections 13b.2.1 and 13b.2.4, is sufficient and meets the applicable regulatory 

requirements and guidance for the issuance of a construction permit in accordance with 

10 CFR 50.35 and 50.40. Further technical or design information required to complete the 

safety analysis may reasonably be left for later consideration. The staff will confirm that the final 

design conforms to the design basis during the evaluation of SHINE’s FSAR.

13b.4.6 External Events 

In SHINE PSAR Section 13b.2.3, the applicant has identified seismic events, tornados or high 

winds, and a small aircraft crash as external events that can affect the RPF. These are treated 

as design basis accidents for the facility. Flooding has been ruled out due to the site location. 

The SHINE facility has been designed to survive design basis earthquake, tornado and wind 

loads including missiles, and aircraft impacts and keep the facility safety functions intact.

On the basis of its review, the staff has determined that the level of detail provided on SHINE’s 

external events demonstrates an adequate design basis for a preliminary design and satisfies 

the applicable acceptance criteria of the ISG Augmenting NUREG-1537, Part 2, Section 13a2, 

allowing the staff to make the following relevant finding: 

Chapters 2 and 3 of the PSAR discuss the design of the RPF structures, systems, and 

components to withstand external events and the potential associated accidents. The 

radioisotope production facility is designed to withstand the effects of these events. 

Process operations could continue, provided that there would not be undue risk to the 

health and safety of the staff, the public, and the environment. Consequences of natural 

external events that cause facility damage (e.g., seismic events that damage the 

confinement or containment) are within the bounds discussed for other accidents in this 

chapter with a resulting dose consequence less than analyzed for the MHA. Therefore, 

exposure to the staff and the public is within acceptable limits, and external events do 

not pose an unacceptable risk to the health and safety of the public. 

Therefore, the staff finds that the preliminary analysis of external events, as described in SHINE 

PSAR Section 13b.2.3 is sufficient and meets the applicable regulatory requirements and 

guidance for the issuance of a construction permit in accordance with 10 CFR 50.35. Further 

technical or design information required to complete the safety analysis may reasonably be left 

for later consideration. The staff will confirm that the final design conforms to the design basis 

during the evaluation of SHINE’s FSAR.
Accident Analysis

13-40

13b.4.7 Mishandling or Malfunction of Equipment 

SHINE PSAR Section 13b.2.4 presents the evaluation of a malfunction or mishandling of 

equipment (including vessel/line/valve failures, valve misalignments, and other process 

equipment failures) that leads to a loss of control of radiological material within the RPF.

Processes conducted within the RPF include the target solution preparation, molybdenum 

extraction, molybdenum purification, molybdenum packaging, uranyl nitrate conversion, target 

solution cleanup (UREX), thermal denitration, waste processing, noble gas decay storage, and 

process vessel vent gas treatment. Most of the associated process piping, vessels, and 

components are located within hot cells or other enclosures. However, transfer between the 

major processes is via transfer piping located along pipe trenches in the RPF. The 

liquid/aqueous radiological process streams that traverse the RPF are the target solution, uranyl 

nitrate solution, and UREX raffinate. Gaseous transfer lines are also present to transfer off 

gases from the IF to the NGRS for decay storage. Other process streams exist; however, the 

above processes represent the greatest radiological risk. Equipment malfunctions, including a 

loss of integrity of these solution and gas lines, presents the possibility of a radiological release 

at various locations in the RPF.

The molybdenum extraction, purification, and packaging takes place within the three separate 

sections of a hot cell referred to as a supercell. There are three supercells within the RPF that 

are operated in parallel, but independently, to process separate batches of irradiated target 

solution to extract, purify, and package the molybdenum product. The liquid and solid waste 

processing, pumping equipment, and storage tanks are located in hot cells and vaults located 

within the RPF. The NGRS equipment is located within a separate shielded cell within the RPF. 

Section 13b.2.4 addresses the potential for an inadvertent release of radiological material along 

the transfer lines throughout the RPF and within process hot cells and shielded cells due to a 

malfunction of critical equipment. The discussion includes initial conditions and assumptions, 

identification of causes, sequences of events, damage to equipment, quantitative evaluation of 

accident evolution, radiation source term analysis, radiological consequence analysis, and 

safety controls. NRC staff reviewed this discussion and the ISA Summary information in Tables 

13b.1-1-4, “Potential Accident Sequences,” and 13b.1-2-1, “Accident Sequences and 

Associated IROFS,” and determined that the designated SR-SSCs will be available and reliable 

to control accident consequences and likelihoods to the standards proposed in PSAR 

Section 1.2.4, “Design Features and Design Bases.”

SHINE calculated the dose consequences of a loss of control of radiological material within the 

RPF to be within the regulatory limits of 10 CFR Part 20. A TEDE of 3.58 rem is calculated for 

the workers at the facility. This on-site dose is less than the 5 rem regulatory limit specified in 

10 CFR 20.1201. A TEDE of 0.0817 rem is calculated for a member of the public at the site 

boundary, and a TEDE of 0.014 rem is calculated at the nearest residence. The off-site doses 

are less than the 0.1 rem regulatory limit specified in 10 CFR 20.1301.

On the basis of its review, the staff has determined that the level of detail provided on SHINE’s 

loss of control of radiological material within the RPF event demonstrates an adequate design 

basis for a preliminary design and satisfies the applicable acceptance criteria of the ISG 

Augmenting NUREG-1537, Part 2, Section 13b.1, allowing the staff to make the following 

relevant findings: 
Accident Analyses

13-41

(1) The exposure time of workers is assumed to be 10 minutes, which should be 

conservative for workers trained to evacuate in the event of a radiological release.

(2) The applicant adequately considered the consequences of loss of control of 

radiological material within the RPF events. The consequences of the RPF 

mishandling or malfunction events have been analyzed and shown to be bounded by 

the MHA. Radiation doses to the public and staff will be within acceptable limits, and 

the safety and health of the staff and public will be adequately protected.

Therefore, the staff finds that the preliminary analysis of the RPF mishandling or malfunction 

events, as described in SHINE PSAR Section 13b.2.4 is sufficient and meets the applicable 

regulatory requirements and guidance for the issuance of a construction permit in accordance 

with 10 CFR 50.35 and 50.40. Further technical or design information required to complete the 

safety analysis may reasonably be left for later consideration. The staff will confirm that the final 

design conforms to the design basis during the evaluation of SHINE’s FSAR.

13b.4.8 Inadvertent Nuclear Criticality in the Radioisotope Production Facility

In SHINE PSAR Section 13b.2.5.2, “Identification of Causes,” SHINE discussed four distinct 

types of postulated criticality scenarios for which engineered controls an design features have 

been designed to prevent:

(1) Accumulation of metal or oxide fissile material outside of a radiation shielded area of 

the facility, resulting in an inadvertent criticality.

(2) Accumulation of irradiated solution within a radiation shielded area of the facility, 

resulting in an inadvertent criticality.

(3) Accumulation of un-irradiated solution outside of a radiation shielded area of the 

facility, resulting in an inadvertent criticality.

(4) Accumulation of metal or oxide fissile material within a radiation shielded area of the 

facility, resulting in an inadvertent criticality.

Since SHINE considers an inadvertent criticality event in the RPF as highly unlikely, as it would 

be prevented by multiple passive safety-related SSCs and administrative controls under an 

approved margin of subcriticality, no radiological consequence analysis was performed for a 

radiological consequence analysis.

On the basis of its review, the staff has determined that the level of detail provided on SHINE’s 

inadvertent criticality events discussion demonstrates an adequate design basis for a 

preliminary design and satisfies the applicable acceptance criteria of the ISG Augmenting 

NUREG-1537, Part 2, Section 13a2, allowing the staff to make the following relevant finding: 

Since inadvertent criticality events in the RPF are highly unlikely, it is not necessary to 

perform a radiological consequence analysis. The health and safety of the staff and public 

will be adequately protected as a result of multiple passive safety-related SSCs and 

administrative controls designed to prevent a criticality event under an approved margin of 

subcriticality.
Accident Analysis

13-42

Therefore, the staff finds that the preliminary analysis of inadvertent criticality events, as 

described in SHINE PSAR Sections 13b.2.5, is sufficient and meets the applicable regulatory 

requirements and guidance for the issuance of a construction permit in accordance with 

10 CFR 50.35 and 50.40. Further technical or design information required to complete the 

safety analysis may reasonably be left for later consideration. The staff will confirm that the final 

design conforms to the design basis during the evaluation of SHINE’s FSAR.

13b.4.9 Radioisotope Production Facility Fire

As described in SHINE PSAR Section 13b.2.6, the RPF contains processes associated with 

extraction and purification of the Mo-99 product from irradiated target solution, preparation and 

recycling of the target solution, and waste processing. Individual chemical processes are 

located in hot cells and glove boxes which are connected via piping located in pipe trenches 

throughout the RPF. The equipment and processes in the RPF present a potential for fire. 

Ignition and fuel sources in this area are primarily small in nature, with the greatest hazards 

located within process enclosures. In addition to combustibles related to the equipment, there is 

also the potential for the accumulation of hydrogen in a noble gas storage tank.

The applicant identified potential fire events in the RPF that could occur during operations and 

maintenance activities and lead to radioactive releases. Fires that started inside the RPF and 

external fires that propagate into the RPF were considered. Both in-situ and transient sources 

of combustible material were considered as fuel sources for the fire. 

The dose consequences of a fire within the RPF is calculated to be within the regulatory limits of 

10 CFR Part 20. A TEDE of 0.578 rem is calculated for the workers at the facility. This on-site 

dose is less than the 5 rem regulatory limit specified in 10 CFR 20.1201. A TEDE of 0.000877 

rem is calculated for a member of the public at the site boundary, and a TEDE of 0.000123 rem 

is calculated at the nearest residence. The off-site doses are less than the 0.1 rem regulatory 

limit specified in 10 CFR 20.1301.

On the basis of its review, the staff has determined that the level of detail provided on RPF fires 

demonstrates an adequate design basis for a preliminary design and satisfies the applicable 

acceptance criteria of the ISG Augmenting NUREG-1537, Part 2, Section 13b.1, allowing the 

staff to make the following relevant findings:

(1) The exposure time of workers is assumed to be 10 minutes, which should be 

conservative for workers trained to evacuate in the event of a radiological release.

(2) The applicant adequately considered the consequences of fires within the RPF. The 

consequences of the RPF fire event have been analyzed and shown to be bounded by 

the MHA. Radiation doses to the public and staff will be within acceptable limits, and 

the safety and health of the staff and public will be adequately protected.

Therefore, the staff finds that the preliminary analysis of RPF fires, as described in SHINE 

PSAR Sections 13b.2.6, is sufficient and meets the applicable regulatory requirements and 

guidance for the issuance of a construction permit in accordance with 10 CFR 50.35 and 50.40. 

Further technical or design information required to complete the safety analysis may reasonably 

be left for later consideration. The staff will confirm that the final design conforms to the design 

basis during the evaluation of SHINE’s FSAR.
Accident Analyses

13-43

13b.4.10 Analyses of Accidents with Hazardous Chemicals Produced from Licensed Material

The staff evaluated the sufficiency of the analysis of accidents with hazardous chemicals 

produced from licensed material, as described in SHINE PSAR Section 13b.3, “Analyses of 

Accidents with Hazardous Chemicals Produced from Licensed Material,” in part, by reviewing 

the chemical process description, chemical accidents description and consequences estimates 

using the guidance and acceptance criteria from Section 13b.2, “Chemical Process Safety for 

the Radioisotope Processing Facility,” of the ISG Augmenting NUREG-1537, Parts 1 and 2.

Consistent with the review guidance of the ISG Augmenting NUREG-1537, Part 2, 

Section 13b.2, the staff determined whether the PSAR adequately evaluated the chemical 

safety of the planned licensed activities and whether the PSAR identified appropriate 

engineered safety features for construction. 

NRC staff’s chemical process safety review examined the preliminary process description, 

information on preliminary process equipment sizes, the description of the hazard analysis, the 

identified chemical safety-related accidents with their estimated consequences, and identified 

engineered safety features. The staff also considered the scale of the proposed operation, 

historical information on accidents for similar facilities (e.g., fuel cycle facilities) and operations, 

and the general nature of the facility. The staff review focused on determining whether SHINE’s 

proposed design would be adequate to protect against releases and chemical exposures of 

licensed material, hazardous chemicals produced from licensed material, and chemical hazards 

that could affect the safety of licensed material. 

The 2013 memorandum of understanding between the NRC and the Occupational Safety and 

Health Administration directs the NRC to oversee chemical safety issues related to: 

(1) radiation risks of licensed materials, (2) chemical risks of licensed materials, and (3) plant 

conditions that affect or may affect the safety of licensed materials and thus increase radiation 

risk to workers, the public, and the environment. The NRC does not oversee plant conditions 

that do not affect or involve the safety of licensed materials.

PSAR Section 13b described the potential accidents that could be caused by process 

deviations, operator errors or other events internal to the facility and credible external events, 

including natural phenomena. NRC staff reviewed the accident analysis and concurred with 

SHINE’s identification of the confinement system as an engineered safety feature important for 

the mitigation of accidents with hazardous chemicals. The staff also noted that the chemical 

safety analysis would be updated in the FSAR and would reflect the finalized process design. 

NRC staff confirmed that the standards used to assess the consequences to an individual and 

the public from acute chemical exposure are appropriate for the inhalation exposure pathway. 

NRC staff reviewed the chemical process ESFs described in PSAR Section 6b (i.e.,

confinement), and agree that it would reduce the consequences of accidents involving chemical 

hazards and licensed materials.

NRC staff determined that the PSAR analyzes the chemical safety of the proposed activity 

consistent with the existing level of design.

The staff’s review of the preliminary analysis of accidents with hazardous chemicals in 

conjunction with the SHINE’s identification of the confinement system as an ESF allows the staff 

to make the following finding:
Accident Analysis

13-44

SHINE’s preliminary accident analysis in the PSAR has adequately described and 

assessed accident consequences that could result from the handling, storage, or 

processing of licensed materials and that could have potentially significant chemical 

consequences and effects. The PSAR has also identified an ESF (confinement system) 

that will mitigate the consequences of accidents involving hazardous chemicals and 

licensed material. There is reasonable assurance that (1) the questions about chemical 

safety related to licensed material processing can be resolved in the FSAR and (2) the 

facility can be constructed and operated without undue risk to the health and safety of the 

public from chemical hazards associated with licensed material.

Further technical or design information required to complete the safety analysis may reasonably 

be left for later consideration. The staff will confirm that the final design conforms to the design 

basis during the evaluation of SHINE’s FSAR.

13b.4.11 Probable Subjects of Technical Specifications

In accordance with 10 CFR 50.34(a)(5), the staff evaluated the sufficiency of the applicant’s 

identification and justification for the selection of those variables, conditions, or other items 

which are determined to be probable subjects of technical specifications supporting the SHINE 

accident analysis, with special attention given to those items which may significantly influence 

the final design.

SHINE PSAR Table 13b.2.5-1, “Safety-Related SSCs and Technical Specification 

Administrative Controls to Prevent Criticality Accidents,” lists probable administrative technical 

specification controls to prevent criticality events, including controls placed on solution sampling, 

filters, differential pressure monitors, and a solvent control program.

SHINE PSAR Section 13b.2.6.8, “Safety Controls,” lists installed combustible loading in the RPF 

and process enclosures is low; administrative control of the admission and storage of transient 

combustible materials and the performance of hot work is maintained in the RPF; and use of 

and storage of flammable and combustible liquids and gases is consistent with the facility fire 

protection program as probable administrative technical specification controls to ensure 

10 CFR Part 20 dose limits are not exceeded during an RPF fire event.

SHINE PSAR Section 13b.3.4, “Chemical Process Surveillance Requirements,” states that 

“[p]otential variables, conditions, or other items that will be probable subjects of a technical

specification associated with chemical processes controls are provided in Chapter 14.” PSAR 

Sections 14b.2, “Safety Limits and Limiting Safety System Settings,” and 14b.2.5 “Limiting 

Conditions for Operation,” provide the guidelines to be followed for selecting safety limits (SLs), 

limiting safety system settings (LSSSs), and Limiting Conditions for Operation (LCOs) for 

radiochemical and chemical processing in the SHINE RPF.

Based on the information provided in PSAR Table 13b.2.5-1, as well as Sections 13b.2.6.8, 

13b.3.4, 14b.2, and 14b.3 of the SHINE PSAR, the staff finds that identification and justification 

of the proposed technical specifications, SLs, LSSSs, and LCOs is sufficient and meets the 

applicable regulatory requirements for the issuance of a construction permit in accordance with 

10 CFR 50.35. A detailed evaluation of technical specifications, including LCOs and 

surveillance requirements, will be performed during the review of SHINE’s operating license 

application.

13b.5 Summary and Conclusions
Accident Analyses

13-45

The staff evaluated descriptions and discussions of SHINE’s RPF accident analysis, including 

probable subjects of technical specifications, as described in SHINE PSAR Section 13b and 

supplemented by the applicant’s responses to RAIs, and finds that the preliminary accident 

analysis, including the principal design criteria; design bases; information relative to materials of 

construction, general arrangement, and approximate dimensions; and preliminary analysis and 

evaluation of the design and performance of structures, systems, and components of the facility: 

(1) provides reasonable assurance that the final design will conform to the design basis, (2) 

includes an adequate margin of safety, (3) structures, systems, and components adequately 

provide for the prevention of accidents and the mitigation of consequences of accidents, and (4) 

meets all applicable regulatory requirements and acceptance criteria in or referenced in ISG 

Augmenting NUREG-1537.

The staff further notes that SHINE PSAR Section 13b contains sufficient information to conclude 

that the engineered safety features would be expected to function as designed to perform their 

safety functions, and radioactive and chemical hazards associated with SNM can be prevented 

or mitigated to levels that are acceptable. Realistic, but conservative methods, were used to 

compute or estimate potential doses and dose commitments to the public in uncontrolled areas 

and to compute external radiation doses and dose commitments resulting from inhalation by the 

facility workers. Methods of calculating doses from inhalation or ingestion (or both) and direct 

exposure to gamma rays from dispersing plumes of airborne radioactive material are applicable 

and no less conservative than those developed in Chapter 11 of the PSAR.

On the basis of these findings, the staff has made the following conclusions for the issuance of 

a construction permit in accordance with 10 CFR 50.35 and 50.40:

(1) SHINE has described the proposed design of the systems supporting the accident 

analysis, including, but not limited to, the principal architectural and engineering criteria 

for the design, and has identified the major features or components incorporated 

therein for the protection of the health and safety of the public.

(2) Further technical or design information required to complete the safety analysis of the 

cooling systems may reasonably be left for later consideration the FSAR.

(3) There is reasonable assurance that, taking into consideration the site criteria contained 

in 10 CFR Part 100, the proposed facility can be constructed and operated at the 

proposed location without undue risk to the health and safety of the public.

(4) There is reasonable assurance: (i) that the construction of the SHINE facility will not 

endanger the health and safety of the public, and (ii) that construction activities can be 

conducted in compliance with the Commission’s regulations.

(5) The issuance of a permit for the construction of the facility would not be inimical to the 

common defense and security or to the health and safety of the public.

14-1

TECHNICAL SPECIFICATIONS

The principal purpose of the Technical Specifications (TS) is to maintain system performance 

and safe operation. This is accomplished by addressing limiting or enveloping conditions of 

design and operation ensuring that emphasis is placed on the safety of the public, the facility 

staff, and the environment. The TS are typically derived from the facility descriptions and safety 

considerations contained in the safety analysis report (SAR).

This chapter evaluates the probable subjects of TS (PSTS) for the SHINE irradiation facility (IF) 

and radioisotope production facility (RPF) as presented in Chapter 14, “Technical 

Specifications,” of the PSAR, as supplemented by the applicant’s responses to requests for 

additional information (RAIs).

Areas of Review

SHINE PSAR Chapter 14, “Technical Specifications,” provides an evaluation of the PSTS 

identified in the preliminary design of the SHINE facility. SHINE PSAR Section 14a2 covers the 

PSTS for the IF and Section 14b covers PSTS for the RPF.

The staff reviewed SHINE PSAR Chapter 14 against applicable regulatory requirements using 

regulatory guidance and standards to assess the sufficiency of the preliminary design for the 

SHINE facility. The staff reviewed SHINE’s identification and justification for the selection of 

those variables, conditions, or other items which are determined to be probable subjects of 

technical specifications for the facility, with special attention given to those items which may 

significantly influence the final design.

Specific areas of review for this chapter included those PSTS identified in the SHINE IF and 

RPF. Within these review areas, the staff assessed whether the applicant identified PSTS, 

including relevant safety limits, limiting control settings, limiting conditions for operation, 

surveillance requirements, design features that affect function, availability, or reliability of 

structures, systems, or components (SSCs) identified as PSTS, as well as management or 

administrative measures would ensure the availability of SSCs identified as PSTS.

Summary of Application

As stated above and described in SHINE PSAR Section 14, the purpose of the TS is to maintain 

system performance and safe operation emphasizing the safety of the public, the facility staff, 

and the environment. The summary provided below applies to both the IF and RPF (together, 

the SHINE facility).

PSAR Sections 14a2 and 14b identify the variables and conditions that are PSTS for the SHINE 

facility. These may change with the operating license application. These variables and 

conditions are based on the preliminary design of the SHINE facility. SHINE will submit formal 

TS with the operating license application as required by 10 CFR 50.36.

These proposed variables have been identified on the premise that this material presents a 

sound framework upon which a final, complete set of TS can be provided with the operating 

license application. As stated in SHINE PSAR Section 14a2.1, “Introduction,” the format and 

content of the TS will be written with the guidance provided in ANSI/ ANS 15.1, “The 
Technical Specifications

14-2

Development of Technical Specifications for Research Reactors” (ANSI/ANS 2007) (Reference 

55). The TS will comply with the regulations in 10 CFR 50.36, “Technical Specifications.” While 

SHINE is not a fuel reprocessing facility, Technical Specifications for SSCs located inside of the 

SHINE RPF will follow the relevant portions of 10 CFR 50.36 pertaining to fuel reprocessing 

facilities, as described in the ISG Augmenting NUREG-1537, Part 1, Section 14b, “Radioisotope 

Production Facility Technical Specifications” (Reference 4). 

Regulatory Basis and Acceptance Criteria

As previously stated, the TS provide an envelope to maintain system performance and safe 

operation, and are typically derived from the facility descriptions and safety considerations 

contained in the SAR. Therefore, the regulatory basis and acceptance criteria provided below 

apply to both the SHINE IF and RPF.

The staff reviewed Chapter 14 of SHINE’s PSAR against applicable regulatory requirements, 

using regulatory guidance and standards, to assess the sufficiency of the preliminary design 

and performance of SHINE’s facility for the issuance of a construction permit. In accordance 

with paragraph (a) of 10 CFR 50.35, “Issuance of Construction Permits,” a construction permit 

authorizing SHINE to proceed with construction may be issued once the following findings have 

been made:

(1) SHINE has described the proposed design of the facility, including, but not limited to, 

the principal architectural and engineering criteria for the design, and has identified the 

major features or components incorporated therein for the protection of the health and 

safety of the public.

(2) Such further technical or design information as may be required to complete the safety 

analysis, and which can reasonably be left for later consideration, will be supplied in 

the final safety analysis report.

(3) Safety features or components, if any, which require research and development have 

been described by SHINE and SHINE has identified, and there will be conducted, a 

research and development program reasonably designed to resolve any safety 

questions associated with such features or components.

(4) On the basis of the foregoing, there is reasonable assurance that: (i) such safety 

questions will be satisfactorily resolved at or before the latest date stated in the 

application for completion of construction of the proposed facility, and (ii) taking into 

consideration the site criteria contained in part 100, the proposed facility can be 

constructed and operated at the proposed location without undue risk to the health and 

safety of the public.

With respect to the last of these findings, the staff notes that the requirements of 

10 CFR Part 100 are specific to nuclear power reactors, and therefore not applicable to the 

SHINE facility. However, the staff evaluated SHINE’s site specific conditions using site criteria 

similar to 10 CFR Part 100, by using the guidance in NUREG-1537. The staff’s review 

evaluated the geography and demography of the site; nearby industrial, transportation, and 

military facilities; site meteorology; site hydrology; and site geology, seismology, and 

geotechnical engineering to ensure that issuance of the construction permit will not be inimical 

to public health and safety.
Technical Specifications

14-3

The staff’s evaluation of the preliminary design criteria for the SHINE facility’s PSTS does not 

constitute approval of the safety of any design feature or specification. Such approval will be 

made following the evaluation of the final design of the SHINE facility TS, as described in the 

FSAR as part of SHINE’s operating license application.

Applicable Regulatory Requirements

The applicable regulatory requirements for the evaluation of SHINE’s PSTS are as follows:

• 10 CFR 50.34, “Contents of applications; technical information,” paragraph (a), 

“Preliminary safety analysis report.”

Regulatory Guidance and Acceptance Criteria

In applying guidance and acceptance criteria, the staff used its judgment as to which 

acceptance criteria were relevant to SHINE’s proposed facility, as much of this guidance was 

originally developed for nuclear reactors. Given the similarities in SHINE’s proposed facility and 

non-power research reactors, the staff used established guidance documents and the 

Commission’s regulations to determine the acceptance criteria for demonstrating compliance 

with 10 CFR regulatory requirements. For example, the staff used: 

• NUREG-1537, Part 1, “Guidelines for Preparing and Reviewing Applications for the 

Licensing of Non-Power Reactors, Format and Content,” issued February 1996 

(Reference 4).

• 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 (Reference 5).

• “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 (Reference 6).

• “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 (Reference 7).

As stated in the ISG Augmenting NUREG-1537, the staff determined that certain guidance 

originally developed for heterogeneous non-power research and test reactors is applicable to 

aqueous homogenous facilities and production facilities. SHINE used this guidance to inform 

the design of its facility and prepare its PSAR. The staff’s use of reactor-based guidance in its 

evaluation of the SHINE PSAR is consistent with the ISG Augmenting NUREG-1537.

As appropriate, additional guidance (e.g., NRC regulatory guides, Institute of Electrical and 

Electronics Engineers (IEEE) standards, American National Standards Institute/American 

Nuclear Society (ANSI/ANS) standards) has been used in the staff’s review of SHINE’s PSAR. 

The use of additional guidance is based on the technical judgment of the reviewer, as well as 

references in NUREG-1537, Parts 1 and 2; the ISG Augmenting NUREG-1537, Parts 1 and 2; 
Technical Specifications

14-4

and the SHINE PSAR. Additional guidance documents used to evaluate SHINE’s PSAR are 

provided as references in Appendix B of this SER. 

Review Procedures, Technical Evaluation, and Evaluation Findings

As described in SHINE PSAR Section 14, this section evaluates the SHINE PSTS based on the 

preliminary design of the SHINE facility. The TS will be submitted with the operating license 

application as required by 10 CFR 50.36. These PSTS have been formulated on a sound 

framework upon which a final, complete set of specifications can be developed with the 

operating license application. The technical evaluation applies to both the SHINE IF and RPF.

The staff performed an evaluation of the PSTS presented in SHINE PSAR Section 14, as 

supplemented by the applicant’s responses to RAIs, to assess the sufficiency of the preliminary 

design and performance of the SHINE facility for the issuance of a construction permit, in 

accordance with 10 CFR 50.35(a). The sufficiency of the SHINE facility’s PSTS is determined 

by ensuring the design and performance meet applicable regulatory requirements, guidance, 

and acceptance criteria, as discussed in Section 14.3, “Regulatory Basis and Acceptance 

Criteria,” of this SER. The results of this technical evaluation are summarized in SER 

Section 14.5, “Summary and Conclusions.”

For the purposes of issuing a construction permit, the identification of the SHINE facility PSTS 

may be adequately described at a functional or conceptual level. The staff evaluated the 

sufficiency of the preliminary design of the SHINE facility based on the applicant’s design 

methodology and ability to provide reasonable assurance that the final design will conform to 

the design bases with adequate margin for safety. As such, the staff’s evaluation of the 

preliminary design of the SHINE facility does not constitute approval of the safety of any design 

feature or specification. Such approval will be made following the evaluation of the final design 

of the SHINE facility, as described in the FSAR, as part of SHINE’s operating license 

application.

In accordance with 10 CFR 50.34(a)(5), the staff evaluated the sufficiency of the applicant’s 

identification and justification for the selection of those variables, conditions, or other items 

which are determined to be probable subjects of technical specifications for the SHINE facility, 

with special attention given to those items which may significantly influence the final design.

Consistent with the review procedures of NUREG 1537, Part 2, Chapter 14, “Technical 

Specifications,” and the ISG Augmenting NUREG-1537, Part 2, Section 14b, the staff confirmed 

that the PSTS and basis were determined from the analysis in the PSAR and confirmed that 

each PSTS is supported by appropriate references to PSAR analyses and statements.

SHINE PSAR Table 4a2-1, “SHINE Facility Proposed Parameters for Technical Specifications,” 

groups anticipated safety limits and limiting safety system settings by chapter, including the 

bases for the identification and selection of each parameter. Further explanation and analysis 

of selected parameters is provided in relevant chapters of the SHINE PSAR. The staff’s 

evaluations of SHINE’s PSTS are provided in the corresponding chapters of this SER.

The SHINE facility has been designed such that normal operation within the limits of technical 

specifications will not result in off-site radiation exposure in excess of the limits provided in 

10 CFR Part 20. 

In the IF, safety limits (SLs) will be placed on important process variables, as necessary to 

reasonably preserve the integrity of the primary system boundary (PSB) and prevent the 
Technical Specifications

14-5

uncontrolled release of radioactivity. SLs may also be established for the character and quality 

of the target solution. For irradiated and unirradiated special nuclear material outside of the 

TSV, SLs are derived for criticality accident prevention. Limits are specified, using the 

double-contingency principal, to avoid a criticality accident with conservative margins of 

subcriticality. Safety limits will also be developed for radiochemical and chemical processing, 

according to the regulations in 10 CFR 50.36.

Limiting conditions for operation (LCOs) in both the IF and RPF are derived from the safety 

analyses and are implemented through administrative or engineered controls to ensure safe 

operation of the facility.

Surveillance requirements for both the IF and RPF will be provided in TS submitted for the 

SHINE operating license application.

While, administrative controls will be provided in the SHINE operating license application, 

Section 14a2.6, “Administrative Controls,” of SHINE’s PSAR identifies proposed subjects of 

administrative controls, including criticality safety, as low as reasonably achievable 

considerations, waste container procurement and transport, fire protection, solvent control, 

tritium control, light water coolant activity monitoring, and chemical control.

Based on the information provided in SHINE PSAR Chapter 14, as well as other chapters of the 

SHINE PSAR, the staff finds that identification and justification of the proposed technical 

specifications is sufficient and meets the applicable regulatory requirements for the issuance of 

a construction permit in accordance with 10 CFR 50.35. A detailed evaluation of technical 

specifications, including SLs, LSSSs, LCOs, surveillance requirements, and administrative 

controls, will be performed during the review of SHINE’s operating license application.

Summary and Conclusions

As described in SHINE PSAR Section 14, this section identifies the SHINE PSTS based on the 

preliminary design of the SHINE facility. These PSTS have been formulated on a sound 

framework upon which a final, complete set of specifications can be developed with the 

operating license application. The summary and conclusions provided below apply to both the 

SHINE IF and RPF.

The staff evaluated the descriptions and discussions of the SHINE facility’s PSTS, as described 

in Chapter 14 and other relevant chapters of the SHINE PSAR, and finds that the PSTS of the 

SHINE’s SSCs meet all applicable regulatory requirements and acceptance criteria in 

NUREG-1537 and the ISG augmenting NUREG-1537. Based on these findings, the staff has 

made the following conclusions for the issuance of a construction permit in accordance with 

10 CFR 50.35:

(1) Further technical or design information required to complete the safety analysis of the 

SHINE TS may reasonably be left for later consideration the FSAR.

(2) There is reasonable assurance that, taking into consideration the site criteria contained 

in 10 CFR Part 100, the proposed facility can be constructed and operated at the 

proposed location without undue risk to the health and safety of the public.

15-1

FINANCIAL QUALIFICATIONS

Financial qualifications establish whether an applicant is financially qualified to own, construct, 

operate, and decommission a non-power production or utilization facility. Financial 

qualifications related to the issuance of a construction permit include estimates of construction 

costs, estimates of fuel cycle costs, and sources to cover costs.

This chapter of the SHINE Medical Technologies, Inc. (SHINE or the applicant) construction 

permit safety evaluation report (SER) describes the review and evaluation of the U.S. Nuclear 

Regulatory Commission (NRC) staff (the staff) of SHINE’s financial qualifications, as presented 

in Chapter 15, “Financial Qualifications,” of the SHINE PSAR, as supplemented by the 

applicant’s responses to requests for additional information (RAIs).

Areas of Review

SER Chapter 15, “Financial Qualifications,” provides an evaluation of SHINE’s financial ability to 

construct its proposed facility, as presented in SHINE PSAR Chapter 15, within which, SHINE 

describes its financial ability to construct, operate and decommission the SHINE facility and 

provides information regarding foreign ownership, control, or domination (FOCD), as well as 

nuclear insurance and indemnity.

The staff reviewed PSAR Section 15.1, “Financial Ability to Construct the SHINE Facility,” 

against applicable regulatory requirements using regulatory guidance and standards to assess 

the sufficiency of the financial qualification (FQ) related to the construction of the SHINE facility. 

As part of this review, the staff evaluated information and discussions of SHINE’s FQ, with 

special attention to the financial ability of the applicant to cover costs of construction.

Areas of review for this section included estimates of construction costs, estimates of fuel cycle 

costs, and sources to cover costs. SHINE provided additional information related to its financial 

ability to operate and decommission the SHINE facility. The additional information provided is 

not required by 10 CFR 50.33(f)(1) and is outside the scope of the financial qualifications 

necessary for issuing a construction permit, and therefore, will be evaluated further during the 

review of SHINE’s operating license application.

Summary of Application

PSAR Section 15.1 presents information related to SHINE’s financial ability to construct its 

facility, including discussions demonstrating that it possesses, or has reasonable assurance of 

obtaining, the funds necessary to cover estimated construction costs and related fuel cycle 

costs. This section also provides budgetary estimates based on the preliminary design of the 

SHINE facility and the various committed sources of financing, including equity, debt and 

government grants. 

PSAR Section 15.2, “Financial Ability to Operate the SHINE Facility,” presents information 

demonstrating that SHINE possesses, or has reasonable assurance of obtaining, the funds 

necessary to cover estimated operating costs for the duration of the license. SHINE provides 

estimates for the total annual operating costs for each of the first 5 years of operation of the 

facility. 
Financial Qualifications

15-2

PSAR Chapter 15.3, “Financial Ability to Decommission the SHINE Facility,” presents 

information indicating how reasonable assurance will be provided that funds will be available to 

decommission the facility. 

PSAR Sections 15.4, “Foreign Ownership, Control, or Domination,” presents information 

regarding the makeup of the private corporation, from shareholders to board members. 

PSAR Section 15.5, “Nuclear Insurance and Indemnity,” presents information indicating that 

SHINE is covered by the insurance and financial protection requirements of the Price-Anderson 

Act, pursuant to Section 170 of the Atomic Energy Act (AEA) of 1954, as amended.

Additional information related to SHINE’s financial qualifications, related to the requirements of 

10 CFR 50.33, was submitted by letter dated March 26, 2013, as most recently updated by 

letter dated September 16, 2015 (Reference 100).

As required by 10 CFR 50.33(f)(1), areas of review for this section included estimates of 

construction costs, estimates of fuel cycle costs, and sources to cover costs. The additional 

information SHINE provided related to its financial ability to operate and decommission the 

SHINE facility is outside the scope of the financial qualifications necessary for issuing a 

construction permit, and therefore, will be evaluated further during the review of SHINE’s 

operating license application. 

Regulatory Basis and Acceptance Criteria

The staff reviewed SHINE PSAR Chapter 15 against applicable regulatory requirements, using 

regulatory guidance and standards, to assess the sufficiency of SHINE’s FQ for the issuance of 

a construction permit in accordance with the requirements of the Atomic Energy Act of 1954, as 

amended, and Title 10 of the Code of Federal Regulations (10 CFR).

Applicable Regulatory Requirements

The applicable regulatory requirements for the evaluation of the SHINE’s FQ are as follows:

• 10 CFR 50.33, “Contents of applications; general information.”

• 10 CFR 50.40, “Common standards.”

• 10 CFR Part 50, Appendix C, “A Guide for the Financial Data and Related Information 

Required to Establish Financial Qualifications for Construction Permits and Combined 

Licenses.”

Regulatory Guidance and Acceptance Criteria

In applying guidance and acceptance criteria, the staff used its judgment as to which 

acceptance criteria were relevant to SHINE’s proposed facility, as much of this guidance was 

originally developed for nuclear reactors. Given the similarities in SHINE’s proposed facility and 

non-power research reactors, the staff used established guidance documents and the 

Commission’s regulations to determine the acceptance criteria for demonstrating compliance 

with 10 CFR regulatory requirements. For example, the staff used: 
Financial Qualifications

15-3

• NUREG-1537, Part 1, “Guidelines for Preparing and Reviewing Applications for the 

Licensing of Non-Power Reactors, Format and Content,” issued February 1996 

(Reference 4).

• 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 (Reference 5).

• “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 (Reference 6).

• “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 (Reference 7).

Review Procedures, Technical Evaluation, and Evaluation Findings

As described in SHINE PSAR Chapter 15, for the purposes of issuing a construction permit, 

financial qualifications establish SHINE’s financial ability to construct its facility, including 

discussions demonstrating that it possesses, or has reasonable assurance of obtaining, the 

funds necessary to cover estimated construction costs and related fuel cycle costs. The 

technical evaluation provided below in Sections 15.4.1 through 15.4.5 applies to the SHINE 

facility.

The staff performed an evaluation of the financial information presented in SHINE PSAR 

Section 15, as supplemented by information provided in letter dated September 16, 2015, and 

the applicant’s responses to RAIs, to assess the sufficiency of SHINE’s FQ for the issuance of a 

construction permit, in accordance with 10 CFR 50.33 and Appendix C to 10 CFR Part 50. The 

sufficiency of SHINE’s financial qualification information is demonstrated by compliance with 

applicable regulatory requirements, guidance, and acceptance criteria, as discussed in Section 

15.3, “Regulatory Basis and Acceptance Criteria,” of this SER. The results of this technical 

evaluation are summarized in SER Section 15.5, “Summary and Conclusions.”

As stated above, areas of review for this section included estimates of construction costs, 

estimates of fuel cycle costs, and sources to cover costs. The additional information SHINE 

provided related to its financial ability to operate and decommission the SHINE facility, as well 

as information related to FOCD and nuclear insurance and indemnity is outside the scope of the 

financial qualifications necessary for issuing a construction permit, and therefore, will be 

evaluated further during the review of SHINE’s operating license application.

Financial Ability to Construct the SHINE Facility

The staff evaluated the sufficiency of SHINE’s financial ability to construct the SHINE facility, as 

described in SHINE PSAR Section 15.1, “Financial Ability To Construct the SHINE Facility,” 

using the guidance and acceptance criteria from Section 15.1, “Financial Ability to Construct a 

Non-power Reactor,” of NUREG-1537, Parts 1 and 2, and the ISG Augmenting NUREG-1537, 

Parts 1 and 2.
Financial Qualifications

15-4

Consistent with the review procedures of NUREG 1537, Part 2, Section 15.1, the staff evaluated 

the applicant’s estimates of construction cost, including calculations of the design architect or 

the engineering company, and construction bids; estimates of fuel cycle costs related to the 

target solution; sources of construction funding, including the amounting of funding that is 

committed, and the amount that is potentially available; and a breakdown of costs into major 

cost elements, such as material and labor, and include a detailed schedule of construction 

activity in today’s dollars.

In the course of reviewing SHINE’s estimates of construction costs, the staff determined that 

additional information was necessary on the bases for the total production plant costs, support 

facility costs, plant equipment, and 1-year supply of uranium inventory, in order to determine the 

adequacy of SHINE’s estimated construction costs. This information was necessary to 

demonstrate compliance with 10 CFR Part 50, Appendix C.I.A.1, “Estimate of Construction 

Costs,” which states that the estimate of construction costs for production and utilization 

facilities other than nuclear power reactors should be itemized by categories of cost in sufficient 

detail to permit an evaluation of its reasonableness. Therefore, in RAI FA-1 (Reference 14), 

SHINE was asked to provide additional information on the bases from which its construction 

cost estimates were derived.

In response to RAI FA-1 (Reference 20), and pursuant to 10 CFR 50.33(f)(1) and 10 CFR 

Part 50, Appendix C, Section I.A.1, “Estimate of construction costs,” the applicant outlined the 

projected costs for the construction of the proposed facility in Table FA-1-1, “Revised Estimate 

of Construction Costs.”

The applicant described the basis for each element of the estimate in the table. According to 

the application, the total plant production plant costs and plant equipment cost estimates were 

prepared by M.A. Mortenson Company (Mortenson), SHINE’s construction consultant. The 

consultant is an established construction company that provides planning, program 

management, preconstruction, general contracting, construction management, design-build, and 

turnkey development across a variety of industries. The support facility costs estimate uses 

standard construction cost of $130-135/square foot and includes items such as a parking lot, 

utility hookups, and architect fees. 

Additionally, according to the SHINE PSAR, as further clarified in response to RAI FA-1, the 

initial price of low enriched uranium was provided by the U.S. Department of Energy, National 

Nuclear Security Administration Production Office at Y-12 National Security Complex in Oak 

Ridge, Tennessee. The price provided was used by SHINE as the basis to calculate an 

approximate cost for a one year supply.

The staff finds this response demonstrates an adequate basis for SHINE’s construction cost 

estimates and satisfies the requirements of 10 CFR 50.33(f)(1) and 10 CFR Part 50, 

Appendix C, Section I.A.1.

Pursuant to 10 CFR Part 50, Appendix C, I.A.2, “Source of construction funds” and as described 

in SHINE PSAR Section 15.1, SHINE has obtained financing for its development and 

construction project using various sources of financing, including equity, debt and government 

grants. As of the time of this evaluation, SHINE has received at least $58 million in 

commitments, including:

a. Cost sharing agreement with the DOE/NNSA: $25 million

b. Equity financing raised to-date: $11.4 million
Financial Qualifications

15-5

c. Alliant Energy shared savings program loan: $4.8 million

d. State of Wisconsin Enterprise Zone Tax Credits: $11.2 million

e. City of Janesville loan packages/guarantees: $4.6 million

f. 90 acres of land for the building site provided by Janesville: $1.0 million

In addition to these commitments, SHINE is in the process of obtaining additional equity capital 

investments. SHINE expects to finance the construction of the facility under either a short-term 

lease, debt agreement, or both.

On the basis of its review, the staff has determined the level of detail provided on SHINE’s 

financial qualifications for construction is reasonable and satisfies the applicable acceptance 

criteria of NUREG-1537, Part 2, Section 15.1 and the ISG Augmenting NUREG-1537, Part 2, 

Section 15.1, allowing the staff to make the following relevant findings: (1) the applicant has 

supplied financial information for construction and fuel cycle costs; and (2) there is reasonable 

assurance that funds will be made available to construct and cover fuel cycle costs for the 

facility and that the financial status of the applicant regarding construction and fuel cycle costs is 

in accordance with the requirements of 10 CFR 50 33(f).

Therefore, the staff finds that SHINE’s FQ for construction, as described in SHINE PSAR 

Section 15.1, meets the applicable regulatory requirements and guidance for of the issuance of 

a construction permit in accordance with 10 CFR 50.33 and 50.40.

Financial Ability to Operate the SHINE Facility

The staff evaluated the sufficiency of SHINE’s financial ability to operate the SHINE facility, as 

described in SHINE PSAR Section 15.2, “Financial Ability to Operate the SHINE Facility,” using 

the guidance and acceptance criteria from Section 15.2, “Financial Ability to Operate a 

Non-power Reactor,” of NUREG-1537, Parts 1 and 2, and the ISG Augmenting NUREG-1537, 

Parts 1 and 2.

As stated above, areas of review for a construction permit included estimates of construction 

costs, estimates of fuel cycle costs, and sources to cover costs as required by 

10 CFR 50.33(f)(1). The additional information SHINE provided related to its financial ability to 

operate the SHINE facility is outside the scope of the financial qualifications necessary for 

issuing a construction permit, and therefore, will be evaluated further during the review of 

SHINE’s operating license application.

Financial Ability to Decommission the SHINE Facility

The staff evaluated the sufficiency of SHINE’s financial ability to decommission the SHINE 

facility, as described in SHINE PSAR Section 15.3, “Financial Ability to Decommission the 

SHINE Facility,” using the guidance and acceptance criteria from Section 15.3, “Financial Ability 

to Decommission a Non-power Reactor,” of NUREG-1537, Parts 1 and 2, and the ISG 

Augmenting NUREG-1537, Parts 1 and 2.

As stated above, areas of review for a construction permit included estimates of 

construction costs, estimates of fuel cycle costs, and sources to cover costs as required by 

10 CFR 50.33(f)(1). The additional information SHINE provided related to its financial ability to 

decommission the SHINE facility is outside the scope of the financial qualifications necessary 

for issuing a construction permit, and therefore, will be evaluated further during the review of 

SHINE’s operating license application.
Financial Qualifications

15-6

Foreign Ownership, Control, or Domination (FOCD)

The staff evaluated the sufficiency of SHINE’s description of FOCD considerations, as 

presented in SHINE PSAR Section 15.4, “Foreign Ownership, Control, or Domination (FOCD),” 

using the regulations at 10 CFR 50.33(d) and guidance and acceptance criteria from Section 

15.4, “Foreign Ownership, Control, or Domination (FOCD),” of NUREG-1537, Parts 1 and 2, and 

the ISG Augmenting NUREG-1537, Parts 1 and 2.

Consistent with 10 CFR 50.33(d) and the guidance in the ISG Augmenting NUREG-1537, the 

staff confirmed whether the application included “a statement as to whether the applicant is 

owned, controlled, or dominated by an alien, foreign corporation, or foreign government.”

According to the SHINE PSAR, SHINE states that it “is a private, closely held corporation that 

currently has approximately 25 shareholders...All [ ] current shareholders holding 1 percent or 

more of SHINE’s stock are U.S. citizens or entities owned or controlled by U.S. citizens. All of 

our current employees holding stock options are U.S. citizens.”

Furthermore, SHINE states that “One of the six directors on SHINE’s Board is a Canadian 

citizen with U.S. permanent resident status. The appointment of one citizen of Canada as a 

director of SHINE has no material impact on SHINE’s current compliance with the requirements 

regarding FOCD in 10 CFR 50.38. SHINE is not acting as an agent or representative of another 

person in filing the [construction permit] CP application.”

On the basis of its review, the staff has determined the level of detail provided on FOCD 

considerations for construction is reasonable and satisfies the requirements of 10 CFR 50.33(d) 

and 50.38. Specifically, the staff finds that SHINE is not owned, controlled, or dominated by an 

alien, foreign corporation, or foreign government.

Therefore, the staff finds that SHINE’s FOCD considerations for construction, as described in 

SHINE PSAR Section 15.4, meet the applicable statutory and regulatory requirements and 

guidance for of the issuance of a construction permit in accordance with 10 CFR 50.35 and 

50.40.

Nuclear Insurance and Indemnity

The staff evaluated the sufficiency of SHINE’s nuclear insurance and indemnity considerations, 

as described in SHINE PSAR Section 15.5, “Nuclear Insurance and Indemnity,” using the 

guidance and acceptance criteria from Section 15.5, “Nuclear Insurance and Indemnity,” of 

NUREG-1537, Parts 1 and 2, and the ISG Augmenting NUREG-1537, Parts 1 and 2.

As stated above, areas of review for a construction permit included estimates of 

construction costs, estimates of fuel cycle costs, and sources to cover costs as required by 

10 CFR 50.33(f)(1). At this time, SHINE has not requested to possess special nuclear material. 

Therefore, the staff will further evaluate the additional information SHINE provided related to 

nuclear insurance and indemnity during the review of SHINE’s operating license application or 

when SHINE applies for a license under 10 CFR Part 70 to possess special nuclear material. 

The construction permit is conditioned such that an operating license will not be issued by the 

Commission unless SHINE submits proof of financial protection and executes an indemnity 

agreement as required by Section 170 of the AEA. 
Financial Qualifications

15-7

Summary and Conclusions

The staff evaluated the descriptions and discussions of SHINE FQ, as described in 

Chapter 15 of the SHINE PSAR, as supplemented by information provided in letter dated 

September 16, 2015, and the applicant’s responses to RAIs, and finds that SHINE has: 

(1) supplied financial information for construction and fuel cycle costs, and (2) provided 

reasonable assurance that funds will be made available to construct and cover fuel cycle costs 

for the facility and that the financial status of the applicant regarding construction and fuel cycle 

costs is in accordance with the requirements of 10 CFR 50 33(f), and therefore, meets all 

applicable regulatory requirements and acceptance criteria in NUREG-1537 and the ISG 

augmenting NUREG-1537. The staff also concluded that SHINE is not subject to foreign 

ownership, control, or domination and that SHINE has provided sufficient information regarding 

nuclear indemnity and insurance for purposes of a construction permit where no materials 

license is held. 

Therefore, the staff has concluded that SHINE has demonstrated adequate FQ for construction, 

for the issuance of a construction permit in accordance with 10 CFR 50.35 and 50.40.

16-1

OTHER LICENSE CONSIDERATIONS

SHINE Medical Technologies, Inc. (SHINE or applicant) Preliminary Safety Analysis Report 

(PSAR) Chapter 16, “Other License Considerations,” states that SHINE will utilize “new and 

appropriately-qualified components and systems to conduct production operations. Discussions 

regarding used components and systems are not applicable to the SHINE facility.” Additionally, 

SHINE states that its proposed facility will “not contain equipment or facilities associated with 

direct medical administration of radioisotopes or other radiation-based therapies.”

The staff evaluated the descriptions and discussions of the SHINE facility in the PSAR, and 

finds that the preliminary design of the SHINE facility does not contain prior use components. 

The staff concluded that an evaluation of the guidelines of Interim Staff Guidance (ISG)

Augmenting NUREG-1537, Part 2 and NUREG-1537, Part 2 is not required because:

(1) All equipment to be installed in the facility is new and purpose built. No prior use 

components are used in the construction of the IF, RFP, or their support systems; and

(2) The facility will not contain equipment of facilities associated with direct medical 

administration of radioisotopes or other radiation-based therapies.

17-1

DECOMMISSIONING AND POSSESSION-ONLY 

LICENSE AMENDMENTS

SHINE Medical Technologies, Inc. (SHINE or applicant) Preliminary Safety Analysis Report 

(PSAR) Chapter 17, “Decommissioning and Possession-Only License Amendments,” states that 

decommissioning information is not required for a construction permit application. As such, the 

SHINE PSAR does not include a decommissioning plan or report.

The staff evaluated this PSAR chapter and concludes that 10 CFR 50.33(k) requires an 

applicant for an operating license to submit a decommissioning report. Because SHINE is a 

construction permit applicant and is not seeking a possession-only license, no decommissioning 

information need be provided in the PSAR or evaluated for the issuance of a construction 

permit.

18-1

HIGHLY ENRICHED TO LOW ENRICHED URANIUM 

CONVERSIONS

SHINE Medical Technologies, Inc. (SHINE or applicant) Preliminary Safety Analysis Report 

(PSAR) Chapter 18, “Highly Enriched to Low Enriched Uranium Conversion,” states that the 

SHINE facility is “a new facility that uses low enriched uranium.” As such, descriptions of 

uranium conversion are not applicable.

The staff evaluated the descriptions of the SHINE facility in the PSAR, and finds that the 

preliminary design of the SHINE facility does not utilize highly enriched uranium. The staff 

concluded that an evaluation of uranium conversion guidelines of Interim Staff Guidance (ISG)

Augmenting NUREG-1537, Part 2 and NUREG-1537, Part 2 is not required because SHINE’s 

facility will only utilize low enriched uranium as target material in the target solution vessel.

A-1

APPENDIX A. POST CONSTRUCTION PERMIT ACTIVITIES –

CONSTRUCTION PERMIT CONDITIONS AND FINAL SAFETY 

ANALYSIS REPORT COMMITMENTS

A.1 Construction Permit Conditions 

The NRC staff (the staff) has determined that additional information is needed to address

certain matters related to nuclear criticality safety and radiation protection in the Radioisotope 

Production Facility (RPF). Therefore, the staff recommends that SHINE’s construction permit, 

should one be granted, be conditioned such that prior to the completion of construction, SHINE 

shall submit periodic reports to the NRC, at intervals not to exceed 6 months from the date of 

the construction permit, providing the information set forth below. These conditions are 

confirmatory in nature and must be satisfied prior to the completion of construction. Additional 

details on the basis for each condition appear in the technical evaluations of the SHINE 

construction permit SER, Chapters 6 and 11, “Radiation Protection Program and Waste 

Management.” 

Proposed

Permit

Condition

SER 

Section Description

1 6b.4.5 The technical basis for the design of the criticality accident 

alarm system (CAAS), including a description of the 

methodology for determining detector placement. The 

technical basis shall demonstrate that the CAAS will meet the 

requirements of 10 CFR 70.24(a) and the commitments listed 

on page 6b-19 of the Preliminary Safety Analysis Report, 

Revision 0.

2 6b.4.5 The basis for determining that criticality events are “not 

credible” for radioisotope production facility (RPF) processes 

even though fissile materials may be present. The basis shall 

demonstrate that the each such event satisfies the definition 

of “not credible,” as described in the SHINE integrated safety 

analysis Summary. 

3 6b.4.5 Summaries of the criticality safety analysis for the affected 

processes that include the following: (1) a list of identified 

criticality hazards, (2) a list of controlled parameters, (3) a 

description of evaluated normal and abnormal conditions, 

(4) a description of the licensee’s approach to meeting the 

double contingency principle, and (5) a list of anticipated 

passive and active engineered controls, including any 

assumptions, to ensure the process(es) will remain subcritical 

under normal and credible abnormal conditions. The 

criticality safety analysis summaries shall demonstrate that all 

RPF processes will remain subcritical under all normal and 

credible abnormal conditions and will satisfy the double 

contingency principle.
Appendix A

A-2

Proposed

Permit

Condition

SER 

Section Description

4 6b.4.5 The relevant nuclear criticality safety evaluations (NCSEs) 

shall address the reactivity contributions from all fissile 

isotopes or SHINE shall apply an additional subcritical margin 

to account for neglecting these nuclides. The treatment of 

fissile nuclides other than U-235, whether through the NCSEs 

or the addition of subcritical margin, shall demonstrate that all 

RPF processes will remain subcritical under all normal and 

credible abnormal conditions.

5 11.4.1 The design information on the RPF supercells, tank vaults 

containing the liquid waste storage tanks, evaporation hot 

cells, and liquid waste solidification hot cells demonstrating 

shielding, and occupancy times within the RPF are consistent 

with as low as is reasonably achievable practices and dose 

requirements of 10 CFR Part 20.
Appendix A

A-3

A.2 Regulatory Commitments Identified in Response to Requests for 

Additional Information

In response to requests for additional information, the applicant has identified elements of 

design, analysis, and administration that require additional research and development or 

correction. SHINE is tracking the status of these items through its Issues Management Report 

(IMR) System. The staff determined that resolution of these items is not necessary for the 

issuance of a construction permit, but the applicant should ensure that these items are fully 

addressed in the FSAR supporting the issuance of an operating license. The staff is tracking 

these items as regulatory commitments and will verify their implementation during the review of 

a SHINE operating license application.

The following regulatory commitments, as identified in SHINE’s response to RAIs, are the 

responsibility of the applicant, and have not yet been fulfilled:

RAI

Number

Date and 

ADAMS 

Accession 

Number for 

SHINE 

Response to RAI Description

3.4-1 December 3, 2014

ML14356A527

An IMR has been initiated to track the inclusion of the final seismic 

analysis results into the FSAR. Specifically, the coefficient of 

variation (COV) will be determined consistent with Section 3.7.2 of 

NUREG-0800, and the results of the final seismic analysis will be 

provided in the FSAR.

3.4-5 December 3, 

2014

ML14356A527

An IMR has been initiated to track seismic qualification of piping 

subsystems for inclusion in the FSAR. SHINE facility piping 

subsystems that are classified as safety-related will be analyzed 

using the dynamic analysis method identified in Subsection 3.4.3 of 

the PSAR, and details of the analysis will be provided in the FSAR. 

3.4-5 December 3, 2014

ML14356A527

An IMR has been initiated to track the inclusion of seismic 

qualification of components in the FSAR. Seismic qualification of 

components in the SHINE facility will be consistent with the one or 

more of the methods: qualification by analytical methods only, 

qualification by tests, and combined methods of qualification. SHINE 

will update Subsection 3.4.3 in the FSAR to include a discussion of 

which seismic qualification method is used for which type of 

component.

3.4-9 April 10, 2015

ML15120A248

An IMR has been initiated to track the inclusion of a description of the 

seismic monitoring system, as discussed below, in the FSAR. SHINE 

has decided that for asset protection and business operations 

purposes, nonsafety-related seismic instrumentation could assist with 

the timely determination of the accelerations experienced at the plant 

following a seismic event. Therefore, SHINE will acquire and install a 

nonsafety-related seismic monitoring system to help establish the 

acceptability of continued operation of the plant following a seismic 

event. This system will provide acceleration time histories or 

response spectra experienced at the facility to assist in verifying that 

structures, systems, and components (SSCs) important to safety at 
Appendix A

A-4

RAI

Number

Date and 

ADAMS 

Accession 

Number for 

SHINE 

Response to RAI Description

the SHINE facility can continue to perform their safety functions. 

SHINE will provide an explanation of the data retrieval and processing 

procedure(s) and state whether or not a separate computer is 

required to view the digitized acceleration time histories and generate

response spectra in the FSAR.

3.5-2 October 15, 2014

ML14296A189

An IMR has been issued to track the addition of the seismic access 

point(s) during final design. The production building seismic portion 

will be provided with at least two safety-related seismic access points 

in the final design, enabling personnel to exit the building following a 

seismic event. These exits will ensure that personnel will be able to 

exit the building and, therefore, will not be exposed to licensed 

material, a chemical exposure from licensed material, or hazardous 

chemicals produced from licensed material in excess of the guidelines 

described in the PSAR.

3.5-7 May 1, 2015

ML15131A464

An IMR has been initiated to track the inclusion of the following 

information in the FSAR. During detailed design, SHINE will 

demonstrate that the Control Room will be within reasonable 

temperatures following a LOOP. Reasonable temperatures are those 

that will ensure safety-related equipment operability and will ensure 

that the Control Room Operators can monitor plant conditions 

following a LOOP. The reasonable temperature range will be 

determined during detailed design. SHINE will describe the method 

chosen to ensure the Control Room remains within a reasonable 

temperature range, and define the reasonable temperature range, in 

the FSAR.

3.5-7 May 1, 2015

ML15131A464

An IMR has been initiated to track the inclusion of the following 

information in the FSAR. SHINE will update the UPSS load list 

provided in Table 8a2.2-1 of the PSAR in the FSAR to include the 

SRM system. The primary means of monitoring the facility stack will 

be with the Stack Release Monitoring (SRM) system. This system will 

provide monitoring of noble gases, aerosols, iodine, and tritium 

effluents. Although nonsafety-related, SHINE will add the SRM 

system to the loads powered by the UPSS, and therefore the SRM 

system will likely be available after a LOOP. The nominal connected 

load and the nominal demand load for the SRM system will be 

determined during detailed design.

4a2.2-5 December 3, 2014

ML14356A527

An IMR has been initiated to track the inclusion of the following 

information in the FSAR: SHINE will update Table 4a2.2-1 of the 

PSAR with potential fission product precipitate levels and provide 

details on removing potential precipitates from the target solution in 

the FSAR.

4a2.8-2 December 3, 2014

ML14356A527

An IMR has been initiated to track completion of the following 

calculations: SHINE will perform calculations during detailed design 

that will ensure there is sufficient margin to deflagration limits.
Appendix A

A-5

RAI

Number

Date and 

ADAMS 

Accession 

Number for 

SHINE 

Response to RAI Description

4a2.8-3 October 15, 2014

ML14296A189

An IMR has been initiated to ensure the final list of automatic trips is 

provided in the FSAR. It is expected that these trip inputs will include 

primary system pressure, sweep gas flow, and hydrogen 

concentration measurements. SHINE will provide a final list of 

automatic trips in Section 4a2.8 of the FSAR.

4a2.8-4 December 3, 2014

ML14356A527

An IMR has been initiated to ensure that the analysis of the TSV offgas condenser heat transfer capabilities is performed consistent with

the conditions and assumptions described: the condenser analysis 

will document the inputs and assumptions to the design of the TSV 

off-gas condenser, including consideration for bounding operating 

pressures and temperatures, corresponding steam vapor pressure, 

expected non-condensable gas concentrations, the impact on 

condenser performance, and operational degradation during the life of 

the condenser. The required TSV off-gas condenser specifications 

will be determined based on the bounding inputs and conservative 

assumptions. Then, an additional 15 percent design margin will be 

applied to the heat transfer area.

4a2.8-6 October 15, 2014

ML14296A189

An IMR has been initiated to track the inclusion of the results in the 

FSAR. During detailed design, SHINE will verify that there is no 

significant amount of NOx gas in the TSV off-gas that could impact 

the TOGS, and the results will be described in the FSAR.

5a2.2-2 October 15, 2014

ML14296A189

An IMR has been issued to ensure the FSAR contains this 

information. SHINE will install adequate instrumentation to identify 

and quantify leakage rates, including very small leaks, and will have 

the ability to identify leak locations as they relate to allowable leakage 

limits and the safety functions of the systems. The details on the type 

and accuracy of the instrumentation will be provided in the FSAR.

6a2.2-1 December 3, 2014

ML14356A527

An IMR has been initiated to track the inclusion of the isolation valve 

locations in the FSAR, specifically, a diagram of the TPS showing the 

gloveboxes and double-walled tritium piping is provided in Figure 

9a2.7-1 of the PSAR. Isolation valve locations will be determined 

during detailed design and provided in the FSAR.

6a2.2-3 December 3, 2014

ML14356A527

An IMR has been initiated to track the inclusion of the isolation valve 

locations in the FSAR. The only significant portion of the tritium 

inventory that is not in a confinement area or double-walled piping is 

the tritium in the neutron drivers. The evaluation of the release of 

tritium from the neutron drivers is described in Subsection 

13a2.2.12.3. Isolation valves will isolate the NDAS from the TPS 

should a leak in NDAS be detected. Isolation valve locations will be 

determined during detailed design and provided in the FSAR.

6a2.2-7 December 3, 2014

ML14356A527

IMR has been initiated to track the inclusion of the isolation valve 

locations in the FSAR. The TPS confinement system is described in 

the SHINE Response to RAI 6a2.2-1. Details of the components that 

comprise the TPS are described in Subsection 9a2.7.1 of the PSAR. 
Appendix A

A-6

RAI

Number

Date and 

ADAMS 

Accession 

Number for 

SHINE 

Response to RAI Description

Isolation valve locations will be determined during detailed design and 

provided in the FSAR. The specific valve locations will be dependent 

on the final design and layout of the system. However, the valves 

locations and number will be sufficient to limit consequences from 

accidents to less than 10 CFR 20 limits.

6a2.2-9 December 3, 2014

ML14356A527

An IMR has been initiated to track the inclusion of the following 

information in the FSAR. TPS confinement is achieved by the TPS 

Confinement System. The TPS will also contain isolation valves. As 

described in the SHINE Response to RAI 6a2.2-1, the necessary 

locations of isolations valves will be determined from the accident 

analysis during detailed design, and will include valves that isolate the 

NDAS from the TPS should a leak in NDAS be detected. Additional 

detail regarding the TPS isolation valves is also provided in the 

SHINE Response to RAI 6a2.2-3. Additional isolation valve details 

will be developed during detailed design, and the FSAR will be 

updated with a list, details, or locations of these isolation valves.

6a2.2-13 October 15, 2014

ML14296A189

An IMR has been initiated to track the inclusion of a description of the 

ESFAS interlocks and bypasses, if any, in the FSAR. A description of 

the ESFAS interlocks and bypasses, if any, will be determined as a 

part of detailed design and provided in the FSAR.

6b.2-8 October 15, 2014

ML14296A189

An IMR has been initiated to track the inclusion of a description of 

channels used in RPF ESF actuation that can be bypassed, RICS 

interlocks (if any), schematics, and functional block diagrams in the 

FSAR.

6b.3-28 May 1, 2015

ML15131A464

An IMR has been initiated to track the inclusion of the following 

information in the FSAR. SHINE will update Subsection 6b.3.1 of the 

PSAR in the FSAR to include a description of the use of moderation 

as a controlled parameter, as described below. If SHINE uses 

moderation as a controlled parameter, the following acceptance 

criteria from NUREG-1520 for moderation control will be met: 

• SHINE will follow ANSI/ANS-8.22-1997 (R2011). 

• When process variables can affect the moderation, the accident 

analysis shows the process variables to be controlled by either 

safety-related SSCs or licensing basis administrative items.

• Moderation is measured by using instrumentation subject to facility 

administrative controls.

• The design of physical structures prevents the ingress of 

moderators.

• When moderation needs to be sampled, dual independent sampling 

methods are used.

• Firefighting procedures for use in a moderation-controlled area 

evaluate the use of moderator material.

• After evaluation of all credible sources of moderation for the 

potential for intrusion into a moderation-controlled area, the ingress 

of moderation is prevented or controlled.
Appendix A

A-7

RAI

Number

Date and 

ADAMS 

Accession 

Number for 

SHINE 

Response to RAI Description

6b.3-29 May 1, 2015

ML15131A464

An IMR has been initiated to track the inclusion of the following 

information in the FSAR. SHINE will perform an analysis regarding 

the receipt of uranium with incorrect enrichment and will consider 

criticality events in the accident analysis associated with receiving the 

incorrect enrichment. These actions will be performed during detailed 

design and the analysis results will be included in the FSAR.

6b.3-29 May 1, 2015

ML15131A464

An IMR has been initiated to track the inclusion of the following 

information in the FSAR. SHINE will update Subsection 6b.3.1 of the 

PSAR in the FSAR to include a description of the use of enrichment 

as a controlled parameter, as described below. SHINE considers 

enrichment to be a controlled parameter. In order to ensure no out-ofspec materials are utilized, SHINE will independently verify uranium 

enrichment upon receipt. Once a shipment of uranium material is 

independently verified to assure enrichment is within specifications, 

then enrichment is no longer a controlled parameter for this material. 

7a2.4-1 October 15, 2014

ML14296A189

An IMR has been initiated to ensure the results of the transient 

analysis are provided in the FSAR. The current TRPS design uses a 

high neutron flux trip from source range measurements during TSV fill 

operations and from high range measurements during irradiation 

operations. Transient behavior will be analyzed using a transient 

system model currently being completed. Transient systems 

modeling will be used for the adequacy of the current nuclear trips to 

prevent unacceptably high reactivity transients as well as verify 

protection capability in all operating modes, including determining if 

there is a need for a period trip during filling operations. The results of 

this analysis will be used as part of detailed design.

8a2.2-1 December 3, 2014

ML14356A527

An IMR has been initiated to track receipt of the test reports. During 

detailed design, the Class 1E battery chargers and voltage regulating 

transformers are to be specified to include electrical isolation 

requirements consistent with IEEE 384-2008. The suppliers of these 

devices are to submit test reports to demonstrate compliance with the 

electrical isolation requirements of IEEE 384-2008.

9a2.1-1 December 3, 2014

ML14356A527

An IMR has been initiated to track the inclusion of the following 

information in the FSAR. RVZ3 areas include the RCA airlocks and 

additional areas which will be defined during detailed design. SHINE 

will identify the additional RVZ3 areas and provide an RVZ3 flow 

diagram in the FSAR.

9a2.3-5 December 3, 2014

ML14356A527

An IMR has been initiated to ensure the Rock County 911 

Communications Center’s SHINE-specific response information 

binder provides specific guidance on the use of firefighting foam at the 

SHINE facility.

9a2.3-7 December 3, 2014

ML14356A527

An IMR has been initiated to ensure that each fire zone is uniquely 

numbered, and the final FHA provides an assessment of each fire 
Appendix A

A-8

RAI

Number

Date and 

ADAMS 

Accession 

Number for 

SHINE 

Response to RAI Description

zone. As detailed design is completed, the Fire Hazards Analysis 

(FHA) will be revised and updated.

9b.7-1 December 3, 2014

ML14356A527

An IMR has been initiated to track the inclusion of the following 

information into the FSAR: A heavy load will be defined as a load 

that, if dropped, may cause radiological consequences that challenge 

10 CFR 20 limits. The heavy load limit, and the associated load drop 

analysis, will be determined during detailed design and provided in 

the FSAR. 

11.1-1 December 3, 2014

ML14356A527

An IMR has been initiated to track the inclusion of the following 

information in the FSAR: Partitioning of airborne radioactive material 

concentrations associated with normal operations into noble gases, 

radioiodines, and particulates will be provided in the FSAR.

11.1-3 October 15, 2014

ML14296A189

An IMR has been initiated to track the inclusion of an ALARA policy 

statement in the Radiation Protection Program. The SHINE Radiation 

Protection Program will include a management policy statement, 

demonstrating SHINE’s responsibility to maintain occupational and 

public radiation exposures ALARA. 

11.1-8 October 15, 2014

ML14296A189

An IMR has been initiated to track the selection of these locations and 

their inclusion in the FSAR. Three direct radiation-monitoring stations 

will be placed in special interest areas such as population centers, 

nearby residences, or schools. The specific locations will be selected 

at a later date and provided in the FSAR.

11.1-8 October 15, 2014

ML14296A189

An IMR has been initiated to track the update to Figure 11.1-3 in the 

FSAR. SHINE will update Figure 11.1-3 of the PSAR in the FSAR to 

include the additional direct radiation-monitoring stations described 

above. A total of 16 direct radiation-monitoring stations will be located 

at the site boundary in each of the 16 compass directions from the 

site center. The site boundary is depicted in Figure 11.1-3 of the 

PSAR.

11.1-8 October 15, 2014

ML14296A189

An IMR has been initiated to track the inclusion of the 15 additional 

direct radiation-monitoring stations described above in the REMP. 

The nine direct radiation-monitoring locations described in Table 11.1-

8 of the PSAR are part of the SHINE Radiological Environmental 

Monitoring Program (REMP).

11.1-18 May 14, 2015

ML15147A211

An IMR has been initiated to track the inclusion of the following 

information in the RP Program and in the FSAR. SHINE will provide 

the following information in the RP Program and in the FSAR, as part 

of detailed design: (1) Information on the location and conditions 

which will result in the installation of radiation area monitors (RAMs); 

and (2) Sufficient information showing that the RAMs will be used in 

locations where exposures may exceed administrative limits under 

normal operations or credible accident conditions, as determined by 

the accident analysis.
Appendix A

A-9

RAI

Number

Date and 

ADAMS 

Accession 

Number for 

SHINE 

Response to RAI Description

11.1-18 May 14, 2015

ML15147A211

An IMR has been initiated to track the inclusion of the following 

information in the RP Program. The requirements for radiation 

surveying and monitoring will be specified in the RP Program. 

Implementing procedures for the RP Program will specify the types, 

times, and methods for radiation sampling and monitoring.

11.1-18 May 14, 2015

ML15147A211

An IMR has been initiated to track the inclusion of the following 

information in the RP Program. Settings for alarm level limits and the 

methodology to be used to establish these values (e.g., administrative 

limits) will be specified in the RP Program.

11.1-18 May 14, 2015

ML15147A211

An IMR has been initiated to track the inclusion of the following 

information in the RP Program. The maintenance and calibration 

requirements for radiological monitoring equipment will be specified in 

the RP Program.

11.2-2 December 3, 2014

ML14356A527

An IMR has been initiated to track the inclusion of the following 

information in the FSAR. Subsection 11.1.2.1 of the PSAR discusses 

SHINE's commitment to the implementation of an ALARA program. 

The design features of the Uranyl Nitrate Preparation (UNP) waste 

streams, while preliminary, are provided below. The UNP subsystem 

process is used to convert uranyl sulfate from the spent target 

solution into uranyl nitrate. A step in this process involves pumping 

the reaction product slurry from the uranyl nitrate conversion tank to 

the uranyl nitrate centrifuge. The centrifuge provides separation of 

precipitated sulfates from the uranyl nitrate solution. The sulfate 

sludge is transferred at the centrifuge discharge to the Solid 

Radioactive Waste Packaging (SRWP) system. The preliminary 

concept for transfer of the sulfate sludge to the SRWP system 

involves moving the sulfate sludge (sulfate solid concentration of 50 

percent by weight) from the centrifuge discharge to shielded 55-gallon 

drums. The centrifuge discharge and the drum loading area will be 

inside a shielded area of the facility. The loaded drums will be sealed 

inside the shielded area in order to prevent spills during handling and 

remotely moved to the waste evaporation hot cell. Following 

evaporation, the waste will be moved to the liquid waste solidification 

hot cell for further processing, remote sampling for waste 

characterization, and surface decontamination activities and 

packaging. All process steps will be performed consistent with written 

procedures which incorporate ALARA practices. The operators will 

be trained in the procedures and ALARA features. Storage of the 

processed waste for the final decay time and shipment consolidation 

will be in the Waste Staging and Shipping Building. SHINE will more 

fully specify waste handling for the UNP subsystem with respect to 

design features used to assure that ALARA considerations are 

effectively implemented during detailed design, and provide those 

details in the FSAR.
Appendix A

A-10

RAI

Number

Date and 

ADAMS 

Accession 

Number for 

SHINE 

Response to RAI Description

11.2-4 December 3, 2014

ML14356A527

An IMR has been initiated to track the inclusion of the following 

information in the FSAR. The generation rates, chemical properties, 

and radiological properties of these two streams (volumes for liquid 

waste and NGRS condensate) will be determined during detailed 

design and provided in the FSAR.

11.2-4 December 3, 2014

ML14356A527

An IMR has been initiated to ensure the equipment downstream of the 

liquid waste storage tanks is specified in detailed design, and is sized 

to allow processing of one tank while the other is filling in order to 

maintain the buffer storage capacity.

11.2-4 December 3, 2014

ML14356A527

An IMR has been initiated to ensure the exact dimensions of the 

Waste Staging and Shipping Building are determined during detailed 

design and provided in the FSAR.

11.2-4 December 3, 2014

ML14356A527

An IMR has been initiated to ensure the final design of the Waste 

Staging and Shipping Building incorporates criteria for shielding 

requirements such that the site dose limits of 10 CFR 20 are met.

11.3-4 May 14, 2015

ML15147A211

An IMR has been issued to track inclusion of the following information 

in the FSAR. The specific criteria for the ventilation systems, 

including minimum flow velocity at openings in these systems, 

maximum differential pressure across filters, and types of filters to be 

used will be determined in detailed design and provided in the FSAR.

12.1-2 October 15, 2014

ML14296A189

An IMR has been initiated to track this update. The required minimum 

qualifications for facility staff will be provided in the FSAR.

12.7-2 October 15, 2014

ML14296A189

An IMR has been initiated to ensure letters of agreement made with 

local support organizations are provided with the SHINE Emergency 

Plan. SHINE will provide letters of agreement made with local 

support organizations that would augment and extend the capability 

of the facility’s emergency organization with the SHINE Emergency 

Plan, which will be provided as part of the SHINE OL Application.

12.7-3 October 15, 2014

ML14296A189

An IMR has been initiated to ensure a description of the positions, 

duties, and responsibilities of the ERO Staff are provided in the 

SHINE Emergency Plan. SHINE will describe the positions, duties, 

and responsibilities of the ERO Staff in the SHINE Emergency Plan, 

provided as part of the SHINE OL Application.

12.7-8 October 15, 2014

ML14296A189

An IMR has been initiated to ensure an appendix containing a listing 

of EPIPs with descriptions for each class of emergency is provided 

with the SHINE Emergency Plan. Consistent with the requirements of 

Section 4.0 of NUREG-0849 (Reference 19), an appendix to the 

SHINE Emergency Plan, listing by title, with description, emergency 

plan implementing procedures (EPIPs) for each class of emergency, 

will be provided with the SHINE Emergency Plan, provided as part of 

the SHINE OL Application.

12.7-9 October 15, 2014

ML14296A189

An IMR has been issued to track these changes: (1) Table 5-1 will be 

supplemented with the changes as described in the RAI response and 

provided in the SHINE Emergency Plan, provided as part of the 
Appendix A

A-11

RAI

Number

Date and 

ADAMS 

Accession 

Number for 

SHINE 

Response to RAI Description

SHINE OL Application; and (2) the SHINE EPIPs will contain the 

changes described in RAI responses. Consistent with Section V of 

Appendix E to 10 CFR 50, procedures for emergency response will be 

submitted to the NRC no less than 180 days before the scheduled 

issuance of the SHINE OL.

12.7-11 October 15, 2014

ML14296A189

An IMR has been initiated to ensure the specific values/setpoints are 

provided with the SHINE Emergency Plan. The specific 

values/setpoints such as effluent monitor used for emergency 

classification will be provided in the SHINE Emergency Plan, provided 

as part of the SHINE OL Application.

12.7-13 October 15, 2014

ML14296A189

An IMR has been initiated to ensure the clarifying language is 

provided with the SHINE Emergency Plan with regard to whose 

responsibility it is to classify an emergency event. Clarifying language 

will be provided with the SHINE Emergency Plan, provided as part of 

the SHINE OL Application.

12.7-14 October 15, 2014

ML14296A189

An IMR has been initiated to ensure the summary descriptions are 

provided in the SHINE Emergency Plan. Consistent with the 

requirements of Section 7.0 of NUREG-0849 (Reference 19), a 

summary description of those actions that could be taken to mitigate 

or correct the problem for each class of emergency will be provided 

with the SHINE Emergency Plan, provided as part of the SHINE OL 

Application.

12.7-15 October 15, 2014

ML14296A189

An IMR has been initiated to ensure a description of the methods for 

assessing collateral damage to the facility is provided in the SHINE 

Emergency Plan. A description of the methods for assessing 

collateral damage to the SHINE facility will be provided with the 

SHINE Emergency Plan, provided as part of the SHINE OL 

Application.

12.7-17 October 15, 2014

ML14296A189

An IMR has been initiated to ensure a description of the 

contamination controls is provided in the SHINE Emergency Plan. 

SHINE will describe the contamination controls that will be in place 

throughout the facility and in close proximity to the contaminated area 

in the SHINE Emergency Plan, provided as part of the SHINE OL 

Application.

12.7-18 October 15, 2014

ML14296A189

An IMR has been initiated to ensure the threshold to categorize 

personnel being surveyed and evacuated through control points as 

“contaminated,” and to be decontaminated before release, is defined 

in the SHINE EPIPs. SHINE will define the threshold to categorize 

personnel being surveyed and evacuated through control points as 

“contaminated,” and to be decontaminated before release, in the 

SHINE EPIPs. Consistent with Section V of Appendix E to 10 CFR 50, 

procedures for emergency response will be submitted to the NRC no 

less than 180 days before the scheduled issuance of the SHINE OL.
Appendix A

A-12

RAI

Number

Date and 

ADAMS 

Accession 

Number for 

SHINE 

Response to RAI Description

12.7-19 October 15, 2014

ML14296A189

An IMR has been initiated to track the inclusion of protective 

measures and exposure guidelines for emergency personnel in the 

SHINE Emergency Plan. SHINE will include protective measures and 

exposure guidelines for emergency personnel in the SHINE 

Emergency Plan, provided as part of the SHINE OL Application.

12.7-20 October 15, 2014

ML14296A189

An IMR has been initiated to ensure a description of the methods is 

provided in the SHINE Emergency Plan. SHINE will describe the 

methods for transmitting radiation dose rates and contamination 

levels onsite and offsite to the element of the emergency organization 

responsible for accident assessment in the SHINE Emergency Plan, 

provided as part of the SHINE OL Application.

12.7-22 October 15, 2014

ML14296A189

An IMR has been initiated to ensure a more complete and clear 

description of the ESC is provided in the SHINE Emergency Plan. 

SHINE will provide a more complete and clear description of the 

Emergency Support Center (ESC), such as its primary location, backup location, capabilities, equipment, and size, in the SHINE 

Emergency Plan, provided as part of the SHINE OL Application.

12.7-23 October 15, 2014

ML14296A189

An IMR has been initiated to track the update to the SHINE 

Emergency Plan. Specifically, for each accident identified in Table 5.1 

of the SHINE Preliminary Emergency Plan, SHINE will provide the 

means of detecting accident conditions, the means of detecting any 

release of radioactive material or hazardous materials, and the means 

of alerting the operations staff of the accident conditions with the 

FSAR. 

12.7-24 October 15, 2014

ML14296A189

An IMR has been initiated to ensure a description of where the first 

aid equipment is located is provided in the SHINE Emergency Plan. 

SHINE will describe where in the facility the first aid equipment is 

located in the SHINE Emergency Plan, provided as part of the SHINE 

OL Application.

12.7-25 October 15, 2014

ML14296A189

An IMR has been initiated to ensure facilities are identified and written 

agreements are provided as part of the SHINE OL Application. 

SHINE will identify the facilities in which arrangements have been 

made to ensure that medical services are available and the medical 

staff is prepared to handle radiological emergencies in the SHINE 

Emergency Plan, provided as part of the SHINE OL Application. 

SHINE will submit the written Letter of Agreement(s) with hospitals to 

ensure that medical services are available and the medical staff is 

prepared to handle radiological emergencies as part of the SHINE OL 

Application.

12.7-26 October 15, 2014

ML14296A189

An IMR has been initiated to ensure a description of whose 

responsibility it is for decontaminating the ambulance, medical 

personnel, and the medical facility, and a description of where the 

procedures for decontamination of emergency medical 

services/equipment/personnel can be found, is provided in the SHINE 
Appendix A

A-13

RAI

Number

Date and 

ADAMS 

Accession 

Number for 

SHINE 

Response to RAI Description

Emergency Plan. SHINE will describe whose responsibility it is for 

decontaminating the ambulance, medical personnel, and the medical 

facility, and will describe where the procedures for decontamination of 

emergency medical services/equipment/personnel can be found, in 

the SHINE Emergency Plan, provided as part of the SHINE OL 

Application.

12.7-28 October 15, 2014

ML14296A189

An IMR has been issued to track the information request needs 

associated with contingency planning. SHINE will confirm that 

arrangements have been made with alternate facilities and ensure 

that sources of alternate equipment are available, if necessary, in the 

SHINE Emergency Plan, provided as part of the SHINE OL 

Application. SHINE will submit the written Letters of Agreement with 

those alternate facilities, describing services, equipment, and 

provisions to be provided in an emergency, if necessary, as part of 

the SHINE OL Application.

12.7-29 October 15, 2014

ML14296A189

An IMR has been initiated to track the update to Section 9.0 of the 

SHINE Emergency Plane. SHINE will provide a revision to Section 

9.0 of the SHINE Preliminary Emergency Plan, removing [“as closely 

as possible”] from the SHINE characterization of recovery, in the 

SHINE Emergency Plan, provided as part of the SHINE OL 

Application.

12.7-30 October 15, 2014

ML14296A189

An IMR has been initiated to ensure a description of the methods and 

responsibilities for assessing the damage to the facility and status of 

the facility’s capabilities to safely control radioactive material or 

hazardous chemicals associated with the process is provided in the 

SHINE Emergency Plan. SHINE will describe the methods and 

responsibilities for assessing the damage to the facility and status of 

the facility’s capabilities to safely control radioactive material or 

hazardous chemicals associated with the process in the SHINE 

Emergency Plan, provided as part of the SHINE OL Application.

12.7-31 October 15, 2014

ML14296A189

An IMR has been initiated to ensure such an explanation is provided 

in the SHINE Emergency Plan. SHINE will explain who will write and 

who will approve the recovery plans and procedures, what elements 

will be included, and where the plans will be kept in the SHINE 

Emergency Plan, provided as part of the SHINE OL Application.

12.7-32 October 15, 2014

ML14296A189

An IMR has been initiated to track the update to Section 10.1 of 

SHINE Preliminary Emergency Plan. SHINE will provide an update to 

Section 10.1 of the SHINE Preliminary Emergency Plan to include 

training targeted to personnel responsible for decision making; 

personnel responsible for transmitting emergency information and 

instructions; personnel responsible for accident assessment; 

radiological monitoring and analysis teams; first aid and rescue 

personnel; medical support personnel; and police, security, 

ambulance, and firefighting personnel, in the list of specific training 
Appendix A

A-14

RAI

Number

Date and 

ADAMS 

Accession 

Number for 

SHINE 

Response to RAI Description

topics in the SHINE Emergency Plan, provided as part of the SHINE 

OL Application.

12.7-33 October 15, 2014

ML14296A189

An IMR has been initiated to ensure a description of how emergency 

drills demonstrate personnel protection measures is provided in the 

SHINE Emergency Plan. SHINE will describe how emergency drills 

demonstrate personnel protection measures, including controlling and 

minimizing hazards to individuals during fires, medical emergencies, 

mitigation activities, search and rescue, and other similar events in 

the SHINE Emergency Plan, provided as part of the SHINE OL 

Application.

12.7-34 October 15, 2014

ML14296A189

An IMR has been initiated to ensure the information below are 

provided in the SHINE Emergency Plan, as part of the SHINE OL 

Application: a) The topics and general content of the training 

programs for onsite and offsite emergency response personnel; b) 

The administration of the training program including responsibility for 

training, the positions to be trained, the schedule for training, the 

frequency of retraining, the use of team training, and the estimated 

number of hours of initial training and retraining; c) The training to be 

provided on the use of protective equipment such as respirators, 

protective clothing, monitoring devices, and other equipment used in 

emergency response; d) The training program for onsite personnel 

who are not members of the emergency staff; and e) Any special 

instructions and orientation tours that the licensee would offer to fire, 

police, medical, and other non-licensee emergency personnel who 

may be required to respond to an emergency to ensure that they 

know the emergency plan, assigned duties, and effective response to 

an actual emergency.

12.7-35 February 6, 2015 

ML15043A404

An IMR has been initiated to track the inclusion of the following in the 

SHINE Emergency Plan: Description of the actions the on-shift 

operators, to include the actions the Shift Supervisor, Senior Facility 

Operator, and Facility Operator, as applicable, will take if they cannot 

ensure their activities can be placed in a safe condition before 

reporting to the on-site assembly area.

12.7-36 April 10, 2015

ML15120A248

An IMR has been initiated to ensure a description of the actions that 

will be taken by on-shift operators if they cannot ensure their activities 

can be placed in a safe condition in the event of an emergency is 

provided in the SHINE Emergency Plan. SHINE will describe the 

actions that will be taken by on-shift operators if they cannot ensure 

their activities can be placed in a safe condition in the event of an 

emergency in the SHINE Emergency Plan, which will be provided as 

part of the SHINE Operating License (OL) Application. 

12.7-36 April 10, 2015

ML15120A248

An IMR has been initiated to ensure a description of the actions that 

will be taken by on-shift operators to ensure their activities are placed 

or remain in a safe condition following a design-basis, beyond design-
Appendix A

A-15

RAI

Number

Date and 

ADAMS 

Accession 

Number for 

SHINE 

Response to RAI Description

basis, security, unplanned (e.g., a radiological release or chemical 

spill), or other type of on-site or off-site event is provided in the SHINE 

Emergency Plan. SHINE will describe the actions that will be taken 

by on-shift operators to ensure their activities are placed or remain in 

a safe condition following a design-basis, beyond design basis, 

security, unplanned (e.g., a radiological release or chemical spill), or 

other type of on-site or off-site event in the SHINE Emergency Plan, 

which will be provided as part of the SHINE OL Application.

12.7-36 April 10, 2015

ML15120A248

An IMR has been initiated to ensure a description of the programmatic 

processes for individuals and their activities, as well as the safety 

systems necessary to maintain safe shutdown in the event of an 

emergency, is provided in the SHINE Emergency Plan. SHINE will 

describe the programmatic processes for individuals and their 

activities, as well as the safety systems necessary to maintain safe 

shutdown in the event of an emergency, in the SHINE Emergency 

Plan, which will be provided as part of the SHINE OL Application.

12C.3 October 15, 2014

ML14296A189

An IMR has been initiated to ensure the SHINE QAPD, provided as 

part of the SHINE OL Application, identifies the documents, 

procedures, and activities which satisfy program requirements, and 

which specific requirements are considered to be satisfied by such 

documents, procedures, and activities. SHINE will identify the 

documents, procedures, and activities which satisfy program 

requirements, and which specific requirements are considered to be 

satisfied by such documents, procedures, and activities, in the SHINE 

QAPD, provided as part of the SHINE OL Application.

13a2-G December 3, 2014

ML14356A527

An IMR has been initiated to track that accident analysis assumptions 

are accounted for in the final design of the SHINE facility. Accident 

analysis assumptions will be accounted for in the design of the SHINE 

facility.

13a2-G December 3, 2014

ML14356A527

An IMR has been issued to ensure release fractions are verified in the 

as constructed facility. As described in Section 3.5 of the PSAR, 

SSCs that are determined to have safety significance are tested 

commensurate with the criteria set forth in ANSI/ANS 15.8 1995 

(R2013) as implemented by the SHINE Quality Assurance Program 

Description (QAPD). This testing will include vendor testing, receipt 

inspection and testing, and as-constructed local and overall leak rate 

testing to verify the design release fractions in the as-constructed 

SHINE facility.

13a2.2-5 May 20, 2015

ML15140A734

An IMR has been issued to track the inclusion of the following 

information in the FSAR. SHINE will ensure that a consistent 

methodology is applied to the final dose calculations. With the FSAR, 

SHINE will provide a description of the following:

• methodology used to derive the site-specific atmospheric dispersion 

and deposition (χ/Q and D/Q) values
Appendix A

A-16

RAI

Number

Date and 

ADAMS 

Accession 

Number for 

SHINE 

Response to RAI Description

• the evaluation of input parameters related to agricultural storage 

times, growing periods, and intake delays appropriate for the SHINE 

site

• selection and use of radioiodine partitioning factors applied in the 

calculations

• applied DCFs for the appropriate iodine species

• dry and wet deposition effects

• source term assumptions and methodology

• final dose calculation results

• credited engineered controls

13b.1-1 December 3, 2014

ML14356A527

An IMR has been generated to ensure assumptions made in the 

calculation of chemical source terms and concentrations are verified 

during detailed design and that the final results are incorporated into 

the FSAR.

13b.1-3 May 1, 2015

ML15131A464

An IMR has been initiated to track the inclusion of the following 

information in the FSAR. The specific human actions credited to 

prevent or mitigate accidents will be identified during detailed design 

and provided with the FSAR.

13b.1-3 May 1, 2015

ML15131A464

An IMR has been initiated to correct the mitigated likelihood in the 

accident analysis. The preventer-type controls are the Process Tanks 

and Piping and the Conduct of Operations Program. The sum of 

these controls results in a mitigated likelihood of -4. Table 13b.1-1-4 

lists a mitigated likelihood for this scenario of -6; however, this 

number is based on SHINE inadvertently double-counting preventive 

controls for robust process tanks.

13b.1-3 May 1, 2015

ML15131A464

An IMR has been initiated to track the inclusion of the following 

information in the accident analysis. SHINE will evaluate an 

exothermic decomposition of ion exchange resin in contact with nitric 

acid scenario in the accident analysis during final design.

13b.1-3 May 1, 2015

ML15131A464

An IMR has been initiated correct the unmitigated consequences to 

the off-site public in the accident analysis. The accident analysis and 

Table 13b.1-1-4 list an unmitigated consequence to the public of IC, 

which is based only on the prompt effects of a criticality.

13b.1-3 May 1, 2015

ML15131A464

An IMR has been initiated to clarify the reporting of an LT IC mitigated 

consequence for workers for “Criticality” Initiating Event Scenario 5, 

found in Table 13b.1-1-4, since this consequence estimate only 

applies to criticalities within shielded areas. The mitigated 

consequences for this scenario are an estimated HC event for 

workers due to the proximity of workers to a postulated unshielded 

criticality accident.
Appendix A

A-17

A.3 Fulfilled Regulatory Commitments Identified in Response to Requests 

for Additional Information

SHINE has fulfilled several regulatory commitments initially identified in responses to RAIs. 

Details of SHINE’s fulfillment of these regulatory commitments, as verified by the staff, are 

provided below:

RAI

Number

Date and ADAMS 

Accession 

Number

for SHINE 

Response to RAI Description

Details of Fulfillment 

and ADAMS 

Accession Number

1.3-1 October 15, 2014

ML14296A189

The Final Safety Analysis Report (FSAR) will 

be updated to correct Figure 1.3-3 

“Production Building Sections Preliminary 

Arrangement,” of the Preliminary Safety 

Analysis Report (PSAR), which indicates 

containment features exist within the SHINE 

facility.

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)

2.2-3 February 6, 2015

ML15043A404

An IMR has been initiated to track the 

updates to Subsection 2.2.3.1.3 and Table 

2.2-4 in the FSAR. SHINE will update 

Subsection 2.2.3.1.3 of the PSAR in the 

FSAR to include a description of the off-site 

toxic gas release analysis. SHINE will also 

update Table 2.2-4 of the PSAR in the FSAR 

to include the chemicals and corresponding 

quantities considered in the off-site toxic gas 

release analysis.

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)

2.2-4 February 6, 2015

ML15043A404

An IMR has been initiated to track the update 

to Subsection 2.2.2.5 in the FSAR. SHINE 

will update Subsection 2.2.2.5 of the PSAR 

in the FSAR to include a description of the 

updated evaluation of the aircraft hazard. 

Subsections 2.2.2.1 through 2.2.2.4 of the 

PSAR do not require updates as a result of 

the updated evaluation of the aircraft hazard.

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)

2.4-5 December 3, 2014

ML14356A527

An IMR has been initiated to track the update 

to Table 2.4-13 in the FSAR. SHINE will 

update Table 2.4-13 of the PSAR in the 

FSAR to include well UJ792 as an additional 

example receptor.

Incorporated into PSAR 

via SMT-2015-019

(see ML15161A336)

2.5-6 December 3, 2014

ML14356A527

An IMR has been initiated to track the 

revision to Subsection 3.4.2.6.3.1 in the 

FSAR. SHINE will revise Subsection 

3.4.2.6.3.1 in the FSAR as follows to more 

accurately reflect the results of the 

geotechnical engineering investigations 

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)
Appendix A

A-18

RAI

Number

Date and ADAMS 

Accession 

Number

for SHINE 

Response to RAI Description

Details of Fulfillment 

and ADAMS 

Accession Number

documented in the Preliminary Geotechnical 

Engineering Report for the SHINE site: 

(1) SHINE will revise the name of the bearing 

pressure soil parameter provided in 

Subsection 3.4.2.6.3.1 of the PSAR to “net 

allowable static bearing capacity” to facilitate 

consistency with Section 7.2.1 of the 

Preliminary Geotechnical Engineering Report 

for the SHINE site, and (2) SHINE will revise 

the unit weight provided in Subsection 

3.4.2.6.3.1 of the PSAR to 121 lb/ft3 to 

represent the bulk (moist) unit weight. This 

bulk unit weight is equivalent to the minimum 

(dry) density values (118 lb/ft3) provided in 

Figures C-12, C-13, and C-14 of the 

Preliminary Geotechnical Engineering Report 

for the SHINE site multiplied by the average 

moisture content (three percent) provided in 

Table C-1 of the Preliminary Geotechnical 

Engineering Report for the SHINE site.

3.2-1 December 3, 2014

ML14356A527

Sections 2.3.1.2.9 and 19.3.2.3.6, 

“Snowpack and Probable Maximum 

Precipitation (PMP),” contain an 

administrative error stating the units for the 

50- and 100-year interval snowpacks are 

inches. Consistent with Figure 7-1 of ASCE 

7-05, the units for the 50- and 100-year 

interval snowpacks are lb/ft2. 

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)

3.4-6 October 15, 2014

ML14296A189

An IMR has been initiated to remove the 

reference to installed seismic instrumentation 

from Subsection 3.4.4. “Seismic 

Instrumentation.” Neither NUREG-1537 nor 

the Interim Staff Guidance (ISG) augmenting 

NUREG-1537 require seismic 

instrumentation for research reactors or 

isotope production facilities. Seismic 

instrumentation is not required as referenced 

under Section IV(a)(4) of Appendix S to 10 

CFR 50 or Section VI(a)(3) of Appendix A to 

10 CFR 100, since the SHINE facility is not a 

nuclear power plant.

As described in the 

SHINE Response to 

RAI 3.4-9, SHINE has 

determined that for 

asset protection and 

business operations 

purposes, a 

nonsafety-related 

seismic monitoring 

system will be installed 

to help establish the 

acceptability of 

continued operation of 

the plant following a 

seismic event.
Appendix A

A-19

RAI

Number

Date and ADAMS 

Accession 

Number

for SHINE 

Response to RAI Description

Details of Fulfillment 

and ADAMS 

Accession Number

3.5-1 October 15, 2014

ML14296A189

As a result of further design work and this 

response, SHINE plans to review and update 

the ISA and ISA Summary. As 

recommended in Section 2.5 of 

NUREG-1513 (Reference 14), SHINE is 

assembling a knowledgeable and 

experienced team to perform the review and 

update. An IMR has been initiated to track 

any necessary PSAR changes associated 

with the results of this analysis.

Necessary PSAR 

changes, resulting from 

the ISA revision, were 

described, and 

provided, via 

SMT-2014-040 

(see ML14356A527).

3.5-4 October 15, 2014

ML14296A189

An IMR has been initiated to track the 

correction of the Facility Control Room 

designation in the FSAR. The SHINE 

Facility Control Room is part of a safetyrelated, Seismic Category I structure. Table 

3.5-1 of the PSAR contains an administrative 

error, stating the Facility Control Room is a 

nonsafety-related, Seismic Category III 

structure. SHINE will correct the designation 

of the Facility Control Room in the FSAR.

Incorporated into PSAR 

via SMT-2015-012 

(see ML15120A248)

3.5b-2 April 10, 2015

ML15120A248

An IMR has been initiated to track the 

revision to Table 3.5b-1 in the FSAR. SHINE 

will revise the “As Applied and Means of 

Compliance” discussion provided for 

Criterion 7 in Table 3.5b-1 in the FSAR as 

shown below. The revised discussion is 

consistent with the “As Applied and Means of 

Compliance” discussion provided for 

Criterion 17, Electric power systems, in 

Table 3.5a-1 of the PSAR.

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)
Appendix A

A-20

RAI

Number

Date and ADAMS 

Accession 

Number

for SHINE 

Response to RAI Description

Details of Fulfillment 

and ADAMS 

Accession Number

4a2.6-2 October 15, 2014

ML14296A189

An IMR has been initiated to track the 

correction of Subsection 4a2.6.1. The text 

should read “will be transferred.” The 

sentence in Subsection 4a2.6.1 of the PSAR 

will be corrected in the FSAR to read: “If at 

any time during the filling process, neutron 

flux, TSV fill volume, or target solution 

temperatures are determined to be outside 

allowable parameters, the entire contents of 

the TSV will be transferred to the TSV dump 

tank via gravity by opening the TSV dump 

valves.”

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)

4a2.8-2 December 3, 2014

ML14356A527

An IMR has been initiated to track the 

inclusion of the following information in the 

FSAR: SHINE will update the description of 

the TSV dimensions in the FSAR to include 

an increased the headspace of the TSV by 

increasing the TSV internal height.

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)

4b-1 October 15, 2014

ML14296A189

An IMR has been initiated to track the 

correction of the typographical error. The 

FSAR will be updated to correct the 

typographical error contained in Subsection 

4b.1.3.3.3.3 of the PSAR. SHINE PSAR, 

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)
Appendix A

A-21

RAI

Number

Date and ADAMS 

Accession 

Number

for SHINE 

Response to RAI Description

Details of Fulfillment 

and ADAMS 

Accession Number

page 4b-9, contains a typographical error: 

“ursanium oxide” should be “uranium oxide.”

4b-2 October 15, 2014

ML14296A189

An IMR has been initiated to track the 

correction of the typographical error. The 

FSAR will be updated to correct the 

typographical error contained in Subsection 

4b.4.1.1.4.1 of the PSAR. SHINE PSAR, 

page 4b-29, contains an apparent 

typographical error: the text in Section 

4b.4.1.1.4.1(b) reads: “The sulfuric acid 

washes of” should be corrected to read: “The 

sulfuric acid washes off.”

SHINE has reviewed 

the wording and 

determined the wording 

in the PSAR is correct. 

See Revision 1 of the 

SHINE Response to 

RAI 4b-2, provided via 

Enclosure 1 of 

SMT-2015-019 

(see ML15161A336).

6a2.2-5 October 15, 2014

ML14296A189

An IMR has been initiated to track the 

correction to Subsection 6a2.2.1.3. 

Subsection 6a2.2.1.3 of the PSAR contains 

an administrative error. SHINE will revise the 

statement in the FSAR as follows: "Safetyrelated mechanical, instrumentation, and 

electrical systems and components are 

designed to ensure that a single failure of an 

active component, in conjunction with an 

initiating event, does not result in the loss of 

the system’s ability to perform its intended 

safety functions. The single failure 

considered is a random failure."

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)

6a2.2-6 October 15, 2014

ML14296A189

An IMR has been initiated to address the 

error. The SHINE facility has a primary and 

a secondary fission product barrier. The 

primary fission product barrier is the primary 

system boundary. The secondary fission 

product barrier is designated the 

confinement boundary or barrier, or just 

confinement. The SHINE facility does not 

have a “secondary confinement barrier.” The 

use of the phrase “secondary confinement 

barrier” was an administrative error.

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)

6a2.2-10 October 15, 2014

ML14296A189

An IMR has been initiated to track the 

inclusion of the table in Section 6a2.2 of the 

FSAR. The bases for the determination of 

which initiating events have radiological 

consequences are provided in Section 

13a2.2 of the PSAR. SHINE will include the 

following table in Section 6a2.2 of the FSAR, 

Incorporated into PSAR 

via SMT-2015-019

(see ML15161A336)
Appendix A

A-22

RAI

Number

Date and ADAMS 

Accession 

Number

for SHINE 

Response to RAI Description

Details of Fulfillment 

and ADAMS 

Accession Number

providing a reference to the Chapter 13 

subsection where the specific radiological 

consequence analysis can be found for each 

initiating event.

6b.2-2 October 15, 2014

ML14296A189

An IMR has been initiated to track the 

correction to Subsection 6b.2.1.3. 

Subsection 6b.2.1.3 of the PSAR contains an 

administrative error. SHINE will revise the 

statement in the FSAR as follows: “Safetyrelated mechanical, instrumentation, and 

electrical systems and components are 

designed to ensure that a single failure of an 

active component, in conjunction with an 

initiating event, does not result in the loss of 

the system’s ability to perform its intended 

safety functions. The single failure 

considered is a random failure.”

Incorporated into PSAR 

via SMT-2015-019

(see ML15161A336)

6b.2-3 October 15, 2014

ML14296A189

An IMR has been initiated to track the 

inclusion of the revised sentence in the 

FSAR. The sentence in Subsection 6b.2.1.4 

of the PSAR, which states that systems open 

to the hot cell atmosphere are provided with 

redundant isolation valves, will be revised in 

the FSAR to state the following: “Systems 

open to the hot cell atmosphere that 

represent a potential unacceptable source of 

leakage are provided with redundant 

isolation valves.”

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)

6b.2-5 October 15, 2014

ML14296A189

An IMR has been initiated to track the 

inclusion of the table in Section 6b.2 of the 

FSAR. The bases for the determination of 

which initiating events have radiological and 

chemical consequences are provided in 

Section 13b.2 and Section 13b.3 of the 

PSAR. In the RPF, ESFs are used to 

mitigate both the radiological and chemical 

consequences of accidents. SHINE will 

include the following table in Section 6b.2 of 

the FSAR, providing a reference to the 

Chapter 13 subsection where the specific 

consequence analysis can be found for each 

initiating event.

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)
Appendix A

A-23

RAI

Number

Date and ADAMS 

Accession 

Number

for SHINE 

Response to RAI Description

Details of Fulfillment 

and ADAMS 

Accession Number

6b.2-6 December 3, 2014

ML14356A527

An IMR has been initiated to track correction 

of the following in the FSAR. Table 6b.1-1 of 

the PSAR provides the RPF DBAs that are 

mitigated by the RPF confinement ESF. The 

RPF MHA is also mitigated by the same 

confinement ESFs, as it is an extension of a 

critical equipment malfunction scenario. 

Section 6b.2 of the PSAR contains an 

administrative error stating that an RPF fire 

does not have consequences that require 

mitigation by ESFs.

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)

6b.3-1 December 3, 2014

ML14356A527

An IMR has been initiated to track the 

inclusion of the reference manual in the 

SHINE OL Application. Specifically, the 

reference manual will contain information 

such as methodology and assumptions. 

SHINE will create the reference manual as 

part of the nuclear criticality safety program 

during detailed design, and will be provided 

as part of the SHINE OL Application.

SHINE provided the 

Nuclear Criticality 

Safety Reference 

Manual via SMT2015-036 

(see ML15222A231).

6b.3-6 December 3, 2014

ML14356A527

An IMR has been initiated to track the update 

to Section 6b.3. SHINE will update Section 

6b.3 of the PSAR in the FSAR to add 

clarification to the statement justifying the 

use of homogeneous uranium conditions 

instead of heterogeneous effects.

Via the SHINE 

Response to RAI 

6b.3-27, provided via 

Enclosure 1 of 

SMT-2015-014 (see 

ML15131A464), SHINE 

stated that 

heterogeneity effects 

will be considered when 

establishing NCS 

controls and limits. 

SHINE revised 

Subsection 6b.3.1 of 

the PSAR to reflect 

consideration of 

heterogeneity effects 

via SMT-2015-019 
Appendix A

A-24

RAI

Number

Date and ADAMS 

Accession 

Number

for SHINE 

Response to RAI Description

Details of Fulfillment 

and ADAMS 

Accession Number

(see ML15161A336).

6b.3-10 December 3, 2014

ML14356A527

An IMR has been initiated to track the 

correction to Subsection 6b.3.1. Subsection 

6b.3.1 of the PSAR contains an 

administrative error, which states: “... and a 

layer of neutron absorbing material integral 

to the tank construction. The second, 

independent criticality-safety control is that 

the most reactive concentration of uranium in 

any tank results in kef f ≤ 0.95, based on 

MCNP analyses.” SHINE will revise the 

above statement in the FSAR to read: “The 

second control is the configuration 

management program. Favorable geometry 

vessels have been shown to remain 

subcritical for all credible abnormal process 

conditions at the optimum concentration of 

fissile material and changes in design 

dimensions during operation. The only way 

to cause the favorable geometry vessels to 

become critical would be to replace the 

vessels with a design that is not favorable 

geometry. This process upset is prevented 

by the configuration management program. 

Therefore, all favorable geometry vessels 

comply with the double contingency principle

without need to control concentration.”

Via the SHINE 

Response to RAI 

6b.3-24, provided via 

Enclosure 1 of 

SMT-2015-014 (see 

ML15131A464), SHINE 

provided clarification on 

how the design for the 

favorable geometry 

tanks adheres to the 

double contingency 

principle. SHINE 

revised Subsection 

6b.3.1 of the PSAR to 

reflect this clarification 

via SMT-2015-019 

(see ML15161A336).

6b.3-24 May 1, 2015

ML15131A464

An IMR has been initiated to track the 

inclusion of the following information in the 

FSAR. The double contingency principle is 

met for this potential change in process 

conditions because 1-TSPS-01T is a 

favorable geometry tank and any solution 

leakage from the tank would enter a 

favorable geometry sump. This leakage 

would be surveilled via leak detection and 

alarm and would be self-revealing. SHINE 

will update Subsection 6b.3.1 of the PSAR in 

the FSAR to provide clarification on how the 

design for the favorable geometry tanks 

adheres to the double contingency principle, 

as described above.

Incorporated into PSAR 

via SMT-2015-019

(see ML15161A336)
Appendix A

A-25

RAI

Number

Date and ADAMS 

Accession 

Number

for SHINE 

Response to RAI Description

Details of Fulfillment 

and ADAMS 

Accession Number

9a2.1-3 May 14, 2015

ML15147A211

An IMR has been initiated to address the 

following error. RVZ3 areas are directly 

supplied air via the RCA supply AHUs 

described above. A small amount of air is 

also transferred from FVZ4 to RVZ3 via the 

use of airlock doors. The SHINE Response 

to RAI 3.5-3 (SHINE’s December 3, 2014 

letter, ML14356A528) contains an 

administrative error, describing RVZ3 areas 

as being supplied by RVZ3 fans. There are 

no RVZ3 fans in the design of the SHINE 

facility.

No action to be taken 

here. IMR initiated to 

identify error. 

Addressed in SHINE 

Response to RAI 

9a2.1-3.

11.1-5 October 15, 2014

ML14296A189

An IMR has been initiated to track the 

inclusion of very high radiation areas in the 

list of restricted area types. The FSAR will 

be updated to include a definition of very 

high radiation areas in the list of restricted 

area types provided in Subsection 

11.1.5.1.1.b.

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)

11.1-6 December 3, 2014

ML14356A527

An IMR has been initiated to track the 

correction in Subsection 11.1.7.2.2.1, Table 

11.1-8, and Figure 11.1-3. SHINE 

inappropriately used the term “CAM” to refer 

to a continuous air sampler in Subsection 

11.1.7.2.2.1 of the PSAR. SHINE will 

employ continuous air samplers at the stated 

locations, with the samples collected and 

analyzed in a laboratory. SHINE will correct 

the terminology in Subsection 11.1.7.2.2.1, 

Table 11.1-8, and Figure 11.1-3 of the PSAR 

in the FSAR.

Incorporated into PSAR 

via Enclosure 1 of 

SMT-2015-019

(see ML15161A336)

11.1-13 May 14, 2015

ML15147A211

An IMR has been initiated to address the 

following inconsistency. Subsection 11.1.1 

of the PSAR states that the goal for the 

normal operations dose rate for normally 

occupied locations in the facility is 0.25 

mrem/hr at the surface, which is inconsistent 

with Subsections 3.5a.10.2.2 and 

3.5b.1.9.2.2 with respect to the design dose 

rate of 0.25 mrem/hr at 12 in. from the 

surface.

No additional action to 

be taken here. IMR 

initiated to identify 

error. Addressed via 

the SHINE Response to 

RAI 11.1-13 and 

incorporated into PSAR 

(see ML15147A211).
Appendix A

A-26

RAI

Number

Date and ADAMS 

Accession 

Number

for SHINE 

Response to RAI Description

Details of Fulfillment 

and ADAMS 

Accession Number

11.2-3 October 15, 2014

ML14296A189

An IMR has been initiated to track the 

revision to Table 11.2-5. SHINE will revise 

Table 11.2-5 of the PSAR in the FSAR to 

require sampling the storage tank after it is 

filled and mixed, as follows:

Incorporated into PSAR 

via SMT-2015-019

(see ML15161A336)

11.2-3 October 15, 2014

ML14296A189

An IMR has been initiated to track the 

revision to Table 11.2-5. SHINE will revise 

Table 11.2-5 in the FSAR to show an influent 

volume of approximately 52,000 gallons per 

year, or roughly 1040 gallons per week 

based on 50 weeks of operation per year.

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)

11.2-3 October 15, 2014

ML14296A189

An IMR has been initiated to track the 

revision to Table 11.2-5. SHINE will revise 

Table 11.2-5 in the FSAR to show an influent 

volume of approximately 35,000 gallons per 

year, or roughly 700 gallons per week based 

on 50 weeks of operation per year.

Incorporated into PSAR 

via SMT-2015-019

(see ML15161A336)

11.2-3 October 15, 2014

ML14296A189

An IMR has been initiated to track the 

revision to Table 11.2-1. SHINE will revise 

Table 11.2-1 of the PSAR in the FSAR to 

show an influent volume of approximately 

52,000 gallons per year of liquid waste, 

consistent with the revision to Table 11.2-5 

described above.

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)

11.2-4 December 3, 2014

ML14356A527

An IMR has been initiated to track the 

revision to Table 11.2-1. SHINE will revise 

Table 11.2-1 of the PSAR in the FSAR to 

show an influent volume of approximately 

52,000 gallons per year of liquid waste. The 

waste volumes provided in the last six rows 

of Table 11.2-1 will be revised as follows:

Incorporated into PSAR 

via SMT-2015-019

(see ML15161A336). 

Revised to reflect 

Revision 1 of the 

SHINE Response to 

RAI 11.2-4, provided 

via Enclosure 3 of 

SMT-2015-004 

(see ML15043A404).
Appendix A

A-27

RAI

Number

Date and ADAMS 

Accession 

Number

for SHINE 

Response to RAI Description

Details of Fulfillment 

and ADAMS 

Accession Number

11.2-4 December 3, 2014

ML14356A527

An IMR has been initiated to track the 

revision to Table 9b.7-7. Table 9b.7-7 of the 

PSAR provides the waste stream chemical 

characterizations. To be consistent with the 

revision to Table 11.2-1, SHINE will revise 

the waste volumes provided in Table 9b.7-7 

in the FSAR, as follows:

Incorporated into PSAR 

via SMT-2015-019 (see 

ML15161A336). 

Revised to reflect 

Revision 1 of the 

SHINE Response to 

RAI 11.2-4, provided 

via Enclosure 3 of 

SMT-2015-004 

(see ML15043A404).

11.2-4 December 3, 2014

ML14356A527

An IMR has been initiated to track the update 

to Figure 9b.7-5 in the FSAR. A liquid 

process flow diagram is provided as Figure 

9b.7-5 of the PSAR. Figure 11.2-4-1, below, 

provides a modified version of Figure 9b.7-5 

showing expected liquid waste generation 

rates and chemical and radiological 

properties for the liquid waste streams, 

washes, rinses, and chemical additions that 

flow to the liquid waste storage tanks 

(1-RLWS-01TA/B). Figure 11.2-4-1 also 

shows tank capacities, processing flow rates, 

a location for interfacing with temporary 

mobile systems if needed, and an estimate 

of the area needed for decay in storage. 

SHINE will update Figure 9b.7-5 of the 

PSAR in the FSAR to incorporate the 

process details described above.

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)
Appendix A

A-28

RAI

Number

Date and ADAMS 

Accession 

Number

for SHINE 

Response to RAI Description

Details of Fulfillment 

and ADAMS 

Accession Number

11.2-4 December 3, 2014

ML14356A527

An IMR has been initiated to track the 

revision to Table 9b.7 7. Table 9b.7-7 of the 

PSAR provides the waste stream chemical 

characterizations and the expected liquid 

waste generation rates. Table 9b.7-7 will be 

revised in the FSAR to be consistent with the 

waste generation rates in the corrected 

Table 11.2-1.

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336). 

Revised to reflect 

Revision 1 of the 

SHINE Response to 

RAI 11.2-4, provided 

via Enclosure 3 of 

SMT-2015-004 

(see ML15043A404).

12.1-1 October 15, 2014

ML14296A189

An IMR has been initiated to track the update 

to Subsection 12.1.2 and Figure 12.1-1. 

SHINE will update Subsection 12.1.2 in the 

FSAR to provide a description of the SHINE 

management levels, consistent with Section 

6.1.1 of ANSI/ANS-15.1-2007. SHINE will 

also update Figure 12.1-1 in the FSAR to 

include the SHINE Review and Audit 

Committee and the Radiation Protection 

Supervisor in the SHINE organizational 

chart.

A description of the 

SHINE management 

levels was incorporated 

into the PSAR via SMT2015-019 (see 

ML15161A336). The 

review/audit 

committees were 

included in the SHINE 

organizational chart 

(Figure 12.1-1) via 

Revision 1 of the 

SHINE Response to 

RAI 12.1-1, provided 

via SMT-2015-039

(See ML15258A348).

12.1-1 October 15, 2014

ML14296A189

An IMR has been initiated to track the update 

to Subsection 12.1.2. SHINE will update 

Subsection 12.1.2 in the FSAR to 

incorporate the responsibilities described 

above. Responsibility for the safe operation 

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)
Appendix A

A-29

RAI

Number

Date and ADAMS 

Accession 

Number

for SHINE 

Response to RAI Description

Details of Fulfillment 

and ADAMS 

Accession Number

of the SHINE facility shall be with the chain 

of command established in the SHINE 

functional organization chart. Individuals at 

the various management levels, in addition 

to having responsibility for the policies and 

operation of the SHINE facility, shall be 

responsible for safeguarding the public and 

facility personnel from undue radiation 

exposures and for adhering to all 

requirements of the operating license and 

technical specifications.

12.1-2 October 15, 2014

ML14296A189

An IMR has been initiated to ensure this 

information is added to the FSAR. The 

FSAR will state that the licensed operator 

training program, including the requalification 

training program, will be developed and 

implemented consistent with 10 CFR 55 as it 

pertains to non-power facilities (e.g., 10 CFR 

55.40(d)).

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)

12.1-2 October 15, 2014

ML14296A189

An IMR has been initiated to ensure this 

information is added to the FSAR. The 

FSAR will state that SHINE will comply with 

the requirements of 10 CFR 55 as it pertains 

to non-power facilities (e.g., 10 CFR 

55.40(d), 10 CFR 55.53(j), 10 CFR 55.53(k), 

10 CFR 55.61(b)(5)). The FSAR will 

describe how SHINE complies with 10 CFR 

55 requirements.

Incorporated into PSAR 

via SMT-2015-019

(see ML15161A336)

12.2-1 October 15, 2014

ML14296A189

An IMR has been initiated to track the update 

to Section 12.2. The Plant Manager (PM) 

holds approval authority for review and audit 

activities. SHINE will update Section 12.2 in 

the FSAR to specify this approval authority.

Section 12.2 of the 

PSAR was revised via 

Revision 1 of the 

SHINE Response to 

RAI 12.2-1, provided 

via SMT-2015-039, to 

state the Chief 

Operating Officer 

(COO) holds approval 

authority for review and 

audit activities

(see ML15258A348).

12.2-1 October 15, 2014

ML14296A189

An IMR has been initiated to track the update 

to Section 12.2. SHINE will update Section 

12.2 in the FSAR to incorporate the detail 

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)
Appendix A

A-30

RAI

Number

Date and ADAMS 

Accession 

Number

for SHINE 

Response to RAI Description

Details of Fulfillment 

and ADAMS 

Accession Number

below of how the review and audit 

committees interact with facility 

management. The review and audit 

committees will interact with facility 

management through the dissemination of 

meeting minutes and meeting reports. 

Consistent with Section 6.2.3 of 

ANSI/ANS-15.1-2007 (Reference 18), 

SHINE will submit a written report or minutes 

of the findings and recommendations of the 

review group to Level 1 management and 

the review and audit group members in a 

timely manner after the review has been 

completed. Consistent with Section 6.2.4 of 

ANSI/ANS-15.1-2007, SHINE will 

immediately report deficiencies uncovered 

that affect nuclear safety to Level 1 

management. SHINE will also submit a 

written report of the findings of the audit to 

Level 1 management and the review and 

audit group members within 3 months after 

the audit has been complete.

12.2-2 October 15, 2014

ML14296A189

An IMR has been initiated to track the 

inclusion of 10 CFR 50.59 safety reviews in 

the list. The FSAR will be updated to include 

10 CFR 50.59 safety reviews in the list of 

items in Subsection 12.2.3 requiring review 

by the SHINE review and audit committee.

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)

12.2-3 October 15, 2014

ML14296A189

An IMR has been initiated to track the update 

to Subsection 12.2.4. SHINE will update 

Subsection 12.2.4 in the FSAR to expand on 

the description of the SHINE audit function. 

SHINE will work to establish relationships 

with other entities to participate in audits of 

the facility. The audit of the facility operations 

will include items such as organization and 

responsibilities, training, IF and RPF 

operations, procedures, logs and records, 

experiments, health physics, technical 

specification compliance, surveillances, audit 

frequencies, and deficiencies.

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)

12.3-1 October 15, 2014

ML14296A189

An IMR has been initiated to track the update 

to Section 12.3. SHINE will update Section 

12.3 in the FSAR to expand on the 

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)
Appendix A

A-31

RAI

Number

Date and ADAMS 

Accession 

Number

for SHINE 

Response to RAI Description

Details of Fulfillment 

and ADAMS 

Accession Number

description of the SHINE method for the 

review and approval of procedures. 

Consistent with Section 6.4 of 

ANSI/ANS-15.1-2007 (Reference 18), 

SHINE shall prepare, review, and approve 

written procedures prior to initiating any of 

the activities listed in Part (a) of the SHINE 

Response to RAI 12.3-1. The procedures 

shall be reviewed by the SHINE review and 

audit committee and approved by Level 2 

management or designated alternates, and 

such reviews and approvals shall be 

documented in a timely manner. Substantive 

changes to procedures related to activities 

listed in Part (a) of the SHINE Response to 

RAI 12.3-1 shall be made effective only after 

documented review by the SHINE review 

and audit committee and approval by Level 2 

management or designated alternates. Minor 

modifications to the original procedure that 

do not change their original intent may be 

made by Level 3 management or higher, but 

the modifications must be approved by Level 

2 or designated alternates. Temporary 

deviations from the procedures may be 

made by the responsible shift manager 

(Level 3 management) or higher individual 

present, in order to deal with special or 

unusual circumstances or conditions. Such 

deviations shall be documented and reported 

within 24 hours or the next working day to 

Level 2 management or designated 

alternates. Review and approval of SHINE 

procedures shall be documented in a timely 

manner, consistent with the SHINE 

Document Control procedure.

12C.1-3 February 6, 2015 

ML15043A404

An IMR has been initiated to track the update 

to Section 12.9 in the FSAR. SHINE will 

update Section 12.9 of the PSAR in the 

FSAR to refer to the current naming 

convention of the SHINE QAPD.

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)

13a2.1-2 October 15, 2014

ML14296A189

An IMR has been initiated to track the 

correction to Table 4a2.8-1 in the FSAR. 

PSB Piping Table 4a2.8-1 of the PSAR 

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)
Appendix A

A-32

RAI

Number

Date and ADAMS 

Accession 

Number

for SHINE 

Response to RAI Description

Details of Fulfillment 

and ADAMS 

Accession Number

contains an administrative error, stating that 

the TSV Off-Gas Condenser 

(1-TOGS-01A-A-H) and the TSV Off-Gas 

Recombiner Condenser (1-TOGS-01A-A-H) 

will be designed and fabricated to meet 

ASME BPVC, Section VIII and ASME B31.3, 

“Process Piping.” ASME B31.3 does not 

apply to the design and fabrication of the 

TSV Off-Gas Condenser and the TSV 

Off-Gas Recombiner Condenser. SHINE will 

correct the applicable codes and standards 

provided in Table 4a2.8-1 for the TSV OffGas Condenser and the TSV Off-Gas 

Recombiner Condenser in the FSAR.

13a2.1-8 December 3, 2014

ML14356A527

An IMR has been initiated to track the 

revision to Subsection 13a2.1.1.1 in the 

FSAR. SHINE will revise Subsection 

13a2.1.1.1 of the PSAR in the FSAR to state 

that the postulated MHA in the IF is the loss 

of TSV integrity.

Incorporated into PSAR 

via SMT-2015-019 

(see ML15161A336)

19.2-1 October 15, 2014

ML14296A189

An IMR has been initiated to address 

equipment material used during construction. 

The SHINE Response to Transportation 

Request #3 (SHINE October 4, 2013, letter, 

ML13303A887) contains an administrative 

error stating that during construction of the 

SHINE facility, SHINE intends to have a 

concrete batch plant located on site. A 

concrete batch plant will not be located on 

the proposed SHINE site during construction. 

Although SHINE has not yet selected the 

source of construction materials, including 

concrete, and designated routes to the 

SHINE site have not yet been determined, 

SHINE expects all construction materials will 

be shipped to the project site by commercial 

truck, utilizing Interstate, U.S., State, and 

County Highways. SHINE does not expect 

deliveries of construction materials, including 

concrete, to go through residential or 

sensitive areas.

No additional action to 

be taken here. IMR 

initiated to identify 

error. Addressed via 

the SHINE Response to 

RAI 19.2-1.

19.2-2 October 15, 2014

ML14296A189

An IMR has been initiated to address 

whether the preoperational phase was 

included within the construction phase or the 

No additional action to 

be taken here. IMR 

initiated to identify 
Appendix A

A-33

RAI

Number

Date and ADAMS 

Accession 

Number

for SHINE 

Response to RAI Description

Details of Fulfillment 

and ADAMS 

Accession Number

operational phase. SHINE did not include 

the preoperational phase described in 

Section 19.2 of the PSAR, between the end 

date of construction activities and the date of 

commercial operation, in either the 

construction phase or the operational phase 

described in Section 19.4 of the PSAR.

error. Addressed via 

the SHINE Response to 

RAI 19.2-2.

19.2-4 October 15, 2014

ML14296A189

An IMR has been initiated to address the 

following: the facility bounding dimensions 

provided in Subsection 19.4.1.2 of the PSAR 

and used in the visual impact assessment 

were based on an earlier facility design, and 

are not current. Additionally, the conceptual 

renderings of the SHINE facility provided in 

Figure 19.4.1-1 of the PSAR were based on 

an earlier facility design, and are not current.

No additional action to 

be taken here. IMR 

initiated to identify 

error. Addressed via 

the SHINE Response to 

RAI 19.2-4.

19.2-4 October 15, 2014

ML14296A189

An IMR has been initiated to address the 

following: as stated in Table 19.4.1 1 of the 

PSAR, 14.54 ac. (5.88 ha) will be temporarily 

disturbed during construction. Section 19.2 

of the PSAR contains an administrative error, 

stating 25.1 ac. would be temporarily 

disturbed during construction.

No additional action to 

be taken here. IMR 

initiated to identify 

error. Addressed via 

the SHINE Response to 

RAI 19.2-4.

19.2-5 October 15, 2014

ML14296A189

An IMR has been initiated to address the 

following: Section 19.2 of the PSAR 

contains an administrative error stating 

decommissioning activities require a peak 

number of 257 workers. As stated in 

Subsection 19.4.7.1 of the PSAR, the 

decommissioning phase will involve a peak 

number of 261 workers. Revising the peak 

number of workers during the 

decommissioning phase from 257 to 261 

does not affect the data, calculations, or 

analyses provided in Chapter 19 of the 

PSAR.

No additional action to 

be taken here. IMR 

initiated to identify 

error. Addressed via 

the SHINE Response to 

RAI 19.2-5.

19.4-1 October 15, 2014

ML14296A189

An IMR has been initiated to address the 

following: the SHINE Responses to Air 

Quality Requests #1 and #5 (SHINE’s 

October 4, 2013 letter, ML13303A887) 

contain an administrative error stating 25.67 

acres of land will be permanently converted 

to industrial facilities during construction 

No additional action to 

be taken here. IMR 

initiated to identify 

error. Addressed via 

the SHINE Response to 

RAI 19.4-1.
Appendix A

A-34

RAI

Number

Date and ADAMS 

Accession 

Number

for SHINE 

Response to RAI Description

Details of Fulfillment 

and ADAMS 

Accession Number

activities. As described in Table 19.4.1-1 of 

the PSAR, SHINE will permanently convert 

25.85 acres of land to industrial facilities 

during construction activities (25.67 acres of 

agricultural land and 0.18 acres of open 

space).

19.4-2 February 6, 2015 

ML15043A404

An IMR has been initiated to address the 

following error. Subsection 19.4.11.2.1 of 

the PSAR contains an administrative error, 

stating that the release of the inventory 

stored in the Noble Gas Removal System 

(NGRS) storage tanks scenario results in a 

total effective dose equivalent (TEDE) of 

7.98 × 10-2 rem at the site boundary and 

1.12 × 10-2 rem for the nearest resident. 

Subsection 13b.2.1.7 of the PSAR correctly 

describes the radiological consequences due 

to a release of inventory stored in the NGRS 

storage tanks. As described in Subsection 

13b.2.1.7, the TEDE to a member of the 

public for the maximum hypothetical accident 

(MHA) in the radioisotope production facility 

(RPF) is 8.20 × 10-2 rem (site boundary) and 

1.15 × 10-2 rem (nearest resident).

No additional action to 

be taken here. IMR 

initiated to identify 

error. Addressed via 

the SHINE Response to 

RAI 19.4-2.
Appendix A

A-35

A.4 Regulatory Commitments Identified Through Meeting with Advisory 

Committee on Reactor Safeguards

Following the meeting on September 22, 2015, with the Radiation Protection and Nuclear 

Materials Subcommittee of the Advisory Committee on Reactor Safeguards, SHINE identified 

elements of design, analysis, and administration that require additional information. SHINE is 

tracking the status of these items through its Issues Management Report (IMR) System. The 

staff determined that resolution of these items is not necessary for the issuance of a 

construction permit, but the applicant should ensure that these items are fully addressed in the 

FSAR supporting the issuance of an operating license. The staff is tracking these items as 

regulatory commitments and will verify their implementation during the review of a SHINE 

operating license application.

The following regulatory commitments, as identified by SHINE, are the responsibility of the 

applicant, and have not yet been fulfilled:

Date and ADAMS 

Accession Number 

for Correspondence Description

September 28, 2015

ML15271A314

SHINE will provide its strategy for addressing an extended shutdown of the 

SHINE facility.

September 28, 2015 

ML15271A290

SHINE will provide an appropriate definition of “safety-related activities.” 

SHINE will update Section 1.3 of the Quality Assurance Program Description 

(QAPD) to include this definition, and provide the updated QAPD as part of 

the SHINE Operating License (OL) Application.
Appendix A

A-36

A.5 Ongoing Research and Development

The provisions of 10 CFR 50.34(a)(8) allow for ongoing research and development to confirm 

the adequacy of the design of structures, systems, and components to resolve safety questions 

prior to the completion of construction. In accordance with 10 CFR 50.34(a)(8), and as 

described in SHINE PSAR Section 1.3.9, “Research and Development,” and in response to RAI 

G-1, SHINE has identified two ongoing research and development activities, as described 

below. The staff is tracking these activities and will verify their resolution prior to the completion 

of construction.

RAI 

Number

Date and ADAMS 

Accession Number 

for 

Correspondence Description

G-1

October 15, 2014

ML14296A189

Irradiation and corrosion testing at Oak Ridge National 

Laboratory to study mechanical performance of materials, 

as described in the PSAR

G-1

October 15, 2014

ML14296A189

Precipitation studies at Argonne National Laboratory to 

ensure precipitation of uranyl peroxide in the target solution 

will not occur.
B-1

APPENDIX B. REFERENCES

1. Letter SMT-2013-023 from SHINE Medical Technologies, Inc., “Part Two of the SHINE 

Medical Technologies, Inc. Application for Construction Permit,” dated May 31, 2013, 

Agencywide Documents Access and Management System (ADAMS) Accession 

No. ML13172A361).

2. Letter SMT-2013-012 from SHINE Medical Technologies, Inc., “Part One of the SHINE 

Medical Technologies, Inc. Application for Construction Permit,” dated March 26, 2013, 

ADAMS Accession No. ML13088A192.

3. Letter SMT-2013-033, from SHINE Medical Technologies, Inc., “Submittal of the SHINE 

Medical Technologies, Inc. Preliminary Emergency Plan,” dated September 25, 2013, 

ADAMS Accession No. ML13269A378.

4. NUREG-1537, Part 1, “Guidelines for Preparing and Reviewing Applications for the 

Licensing of Non-Power Reactors, Format and Content,” February 1996, ADAMS 

Accession No. ML042430055.

5. NUREG-1537, Part 2, “Guidelines for Preparing and Reviewing Applications for the 

Licensing of Non-Power Reactors, Standard Review Plan and Acceptance Criteria,” 

February 1996, ADAMS Accession No. ML042430048.

6. “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,” October 17, 2012, ADAMS Accession No. ML12156A069.

7. “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,” October 17, 2012, ADAMS Accession 

No. ML12156A075.

8. Letter from U.S. Nuclear Regulatory Commission (S. Lynch), to SHINE Medical 

Technologies, Inc. (R. Bynum), “Exemption from Certain Requirements of 10 CFR 

2.101(a)(5), Regarding the Submission of a Construction Permit Application in Two 

Parts,” dated March 20, 2013, ADAMS Accession No. ML13072B195. 

9. Letter SMT-2013-010 from SHINE Medical Technologies, Inc., “Request for Exemption 

to Submit Application for Construction Permit in Two Parts,” dated February 18, 2013, 

ADAMS Accession No. ML13051A007. 

10. Letter from U.S. Nuclear Regulatory Commission (S. Lynch), to SHINE Medical 

Technologies, Inc. (R. Bynum), “Acceptance of Docketing of Part One of the Application 

for Construction Permit,” dated June 25, 2013, ADAMS Accession No. ML13150A280. 

11. Letter from U.S. Nuclear Regulatory Commission (S. Lynch), to SHINE Medical 

Technologies, Inc. (R. Bynum), “Status of the Acceptance Review of Part Two of the 
Appendix B

B-2

Application for Construction Permit,” dated August 28, 2013, ADAMS Accession 

No. ML13233A356. 

12. Letter from U.S. Nuclear Regulatory Commission (S. Lynch), to SHINE Medical 

Technologies, Inc. (R. Bynum), “Acceptance for Docketing of Part Two of the Application 

for Construction Permit,” dated December 2, 2013, ADAMS Accession No. 

ML13316B387. 

13. SHINE Medical Technologies, Inc., “Preliminary Safety Analysis Report,” dated 

June 16, 2015, ADAMS Package Accession No. ML15175A274. 

14. Letter from U.S. Nuclear Regulatory Commission (A. Adams), to SHINE Medical 

Technologies, Inc. (R. Bynum), “Request for Additional Information Regarding 

Application for Construction Permit,” dated September 19, 2014, ADAMS Accession 

No. ML14195A159. 

15. Letter from U.S. Nuclear Regulatory Commission (D. Hardesty for A. Adams), to SHINE 

Medical Technologies, Inc. (R. Bynum), “Request for Additional Information Regarding 

Application for Construction Permit,” dated January 6, 2015, ADAMS Accession 

No. ML15005A407. 

16. Letter from U.S. Nuclear Regulatory Commission (A. Adams), to SHINE Medical 

Technologies, Inc. (R. Bynum), “Request for Additional Information Regarding 

Application for Construction Permit,” dated March 25, 2015, ADAMS Accession 

No. ML15055A116. 

17. Letter from U.S. Nuclear Regulatory Commission (S. Lynch), to SHINE Medical 

Technologies, Inc. (R. Bynum), “Request for Additional Information Regarding 

Application for Construction Permit,” dated April 15, 2015, ADAMS Accession 

No. ML15099A607. 

18. Letter from U.S. Nuclear Regulatory Commission (A. Adams), to SHINE Medical 

Technologies, Inc. (R. Bynum), “Request for Additional Information Regarding 

Application for Construction Permit,” dated September 24, 2015 ADAMS Accession 

Package No. ML15259A164.

19. Application from SHINE Medical Technologies, Inc., “Preliminary Safety Analysis 

Report,” dated August 27, 2015, ADAMS Accession Package No. ML15258A431.

20. Letter SMT-2014-033 from SHINE Medical Technologies, Inc., “Application for 

Construction Permit, Response to Request for Additional Information,” dated 

October 15, 2014, ADAMS Package Accession No. ML14296A189. 

21. Letter SMT-2014-040 from SHINE Medical Technologies, Inc., “Application for 

Construction Permit, Response to Request for Additional Information,” dated 

December 3, 2014, ADAMS Package Accession No. ML14356A527. 

22. Letter SMT-2015-004 from SHINE Medical Technologies, Inc., “Application for 

Construction Permit, Response to Request for Additional Information,” dated 

February 6, 2015, ADAMS Package Accession No. ML15043A404.
Appendix B

B-3

23. Letter SMT-2015-008 from SHINE Medical Technologies, Inc., “Application for 

Construction Permit, Response to Request for Additional Information 11.1-9,” dated 

March 23, 2015, ADAMS Package Accession No. ML15092A397. 

24. Letter SMT-2015-012 from SHINE Medical Technologies, Inc., “Application for 

Construction Permit, Response to Request for Additional Information,” dated 

April 10, 2015, ADAMS Package Accession No. ML15120A248. 

25. Letter SMT-2015-014 from SHINE Medical Technologies, Inc., “Application for 

Construction Permit, Response to Request for Additional Information,” dated 

May 1, 2015, ADAMS Package Accession No. ML15131A464. 

26. Letter SMT-2015-018 from SHINE Medical Technologies, Inc., “Application for 

Construction Permit, Response to Request for Additional Information,” dated 

May 14, 2015, ADAMS Package Accession No. ML15147A211. 

27. Letter SMT-2015-020 from SHINE Medical Technologies, Inc., “Application for 

Construction Permit, Response to Request for Additional Information 13a2.2-5,” dated 

May 20, 2015, ADAMS Package Accession No. ML15140A734. 

28. Letter SMT-2015-033 from SHINE Medical Technologies, Inc., “Application for 

Construction Permit, Response to Request for Additional Information,” dated 

June 19, 2015, ADAMS Package Accession No. ML15183A292. 

29. Letter SMT-2015-036 from SHINE Medical Technologies, Inc., “Application for 

Construction Permit, Response to Request for Additional Information 6b.3-30,” dated 

June 19, 2015, ADAMS Package Accession No. ML15222A231. 

30. Letter SMT-2015-037 from SHINE Medical Technologies, Inc., “Application for 

Construction Permit, Response to Request for Additional Information,” dated 

August 7, 2015, ADAMS Package Accession No. ML15236A140. 

31. Letter SMT-2013-034 from SHINE Medical Technologies, Inc., “Application for 

Construction Permit, Response to Environmental Requests for Additional Information,” 

dated October 4, 2013, ADAMS Accession No. ML13303A887. 

32. Letter SMT-2015-019 from SHINE Medical Technologies, Inc., “SHINE Medical 

Technologies, Inc. Preliminary Safety Analysis Report Revisions Resulting from Request 

for Additional Information,” dated May 21, 2015, ADAMS Accession No. ML15161A336.

33. Nuclear Waste Policy Act of 1982, Public Law No. 97-425, 96 Stat. 2201, 

January 7, 1983. 

34. National Fire Protection Association, “Standard for the Installation of Sprinkler Systems,” 

NFPA 13, 2013 Edition, Quincy, MA. 

35. SHINE Medical Technologies v. 0 - Chapter 03 - Figures 3.4-001 through 3.4-014, dated 

May 31, 2013, ADAMS Accession No. ML13172A291.
Appendix B

B-4

36. SHINE PSAR, Section 8a2.1.4, “SHINE Facility Loads Supported by SDG,” references 

Table 8a2.1-2, “Standby Diesel Generator Load List,” dated May 31, 2013, ADAMS 

Accession No. ML13172A270, page 8a2-6.

37 U.S. Nuclear Regulatory Commission Regulatory Guide 1.69, Revision 1, “Concrete 

Radiation Shields and Generic Shield Testing for Nuclear Power Plants,” dated 

May 2009, ADAMS Accession No. ML090820425.

38. U.S. Department of Transportation, Federal Aviation Administration, “Flight Standards 

Information Management System (FSIMS),” Order 8900.1, September 13, 2007.

39. U.S. Nuclear Regulatory Commission, “Memorandum and Order, In the Matter of Private 

Fuel Storage L.L.C.,” CLI-05-19, dated September 9, 2005, ADAMS Accession 

No. ML052520232.

40. U.S. Department of Energy, “Accident Analysis for Aircraft Crash into Hazardous 

Facilities,” DOE-STD-3014-96, October 1996, Reaffirmed May 2006.

41. International Atomic Energy Agency, “Consideration of External Events in the Design of 

Nuclear Facilities other than Nuclear Power Plants, with Emphasis on Earthquakes,” 

IAEA-TECDOC-1347, March 2003.

42. U.S. Nuclear Regulatory Commission, Regulatory Guide 1.78, Revision 1, “Evaluating 

the Habitability of a Nuclear Power Plant Control Room During a Postulated Hazardous 

Chemical Release,” December 2001, ADAMS Accession No. ML013100014.

43. National Oceanic and Atmospheric Administration, ALOHA® (Areal Locations of 

Hazardous Atmospheres), Version 5.4.4, Technical Documentation, Technical 

Memorandum NOS OR&R 43, November 2013.

44. U.S. Nuclear Regulatory Commission, “Safety Evaluation Report for the American 

Centrifuge Plant in Piketon, Ohio,” Docket No. 70-7004, NUREG-1851, September 2006.

45. SHINE Medical Technologies v. 0 - Chapter 02 - Figures 2.4-001 through 2.4-011, 

SHINE PSAR Figure 2.4-4, “Simplified Groundwater Table Contours Based on 

Measured Groundwater Elevations in Monitoring Wells,” dated May 31, 2013, ADAMS 

Accession No. ML13172A288.

46. “Bedrock Geologic Map of Wisconsin,” prepared by Mudrey et al., published in 1982, is 

available for download from the Wisconsin Geological and Natural History Survey’s 

website (http://wgnhs.uwex.edu/pubs/download_m078paper/).

47. SHINE Medical Technologies v. 0 - Chapter 08 - Figure 8a2.2-001, SHINE PSAR, 

Section 8a2.2.1, “Class 1E UPSS,” references SHINE PSAR Figure 8a2.2-1, “One-Line 

Diagram – Uninterruptible Electrical Power Supply System,” dated May 31, 2013, 

ADAMS Accession No. ML13172A298.

48. U.S. Nuclear Regulatory Commission, Regulatory Guide 1.180, “Guidelines for 

Evaluating Electromagnetic and Radio-Frequency Interference in Safety Related 
Appendix B

B-5

Instrumentation and Control Systems”, Revision 1, October 2003, ADAMS Accession 

No. ML032740277.

49. National Fire Protection Association (NFPA) 70-2008, “National Electric Code”

50. IEEE Std. 384-2008, “IEEE Standard Criteria for Independence of Class 1E Equipment 

and Circuits.”

51. IEEE Std. 1202, “IEEE Standard for Flame-Propagation Testing of Wire and Cable” 

52. NUREG-0849, “Standard Review Plan for the Review and Evaluation of Emergency 

Plans for Research and Test Reactors,” issued October 1983, ADAMS Accession 

No. ML062190191.

53. U.S. Nuclear Regulatory Commission, Regulatory Guide 2.6, “Emergency Planning for 

Research and Test Reactors,” revised March 1983, ADAMS Accession No. 

ML003740234. 

54. ANSI/ANS-15.16-2008, “Emergency Planning for Research Reactors,” revised 

September 23, 2008.

55. ANSI/ANS 15.1-2007, “The Development of Technical Specifications for Research 

Reactors,” Reaffirmed April 24, 2013.

56. U.S. Nuclear Regulatory Commission, Regulatory Guide 5.59, “Standard Format and 

Content for a Licensee Physical Security Plan for the Protection of Special Nuclear 

Material of Moderate or Low Strategic Significance,” Revision 1, February 1983, ADAMS 

Accession No. ML003739253. 

57. ANSI/ANS-15.8-1995, “Quality Assurance Program Requirements for Research 

Reactors.”

58. U.S. Nuclear Regulatory Commission, Regulatory Guide 2.50, “Quality Assurance 

Program Requirements for Research and Test Reactors”, Revision 1, June 2010, 

ML101650030. 

59. U.S. Nuclear Regulatory Commission, NUREG-2183, “DRFC Environmental Impact 

Statement for the Construction Permit for the SHINE Medical Radioisotope Production 

Facility Draft Report for Comment,” dated May 31, 2015, ADAMS Accession 

No. ML15127A241.

60. U.S. Nuclear Regulatory Commission, NUREG-1520, Revision 1, “Standard Review 

Plan for the Review of a License Application for a Fuel Cycle Facility,” 

May 2010, ADAMS Accession No. ML101390110.

61. SHINE Medical Technologies v. 0 - Chapter 13 – “Accident Analysis,” dated 

December 3, 2014, ADAMS Accession No. ML14356A465. 
Appendix B

B-6

62. ANSI/ANS-8.1-1998 (Reaffirmed in 2007), “Nuclear Criticality Safety in Operations with 

Fissionable Materials Outside Reactors,” American Nuclear Society, La Grange Park, 

Illinois, U.S.A.

63. ANSI/ANS-8.3-1997 (Reaffirmed in 2003), “Criticality Accident Alarm System” American 

Nuclear Society, La Grange Park, Illinois, U.S.A.

64. ANSI/ANS-8.7-1998 (Reaffirmed in 2007), “Nuclear Criticality Safety in the Storage of 

Fissile Materials,” American Nuclear Society, La Grange Park, Illinois, U.S.A.

65. ANSI/ANS-8.10-1983 (Reaffirmed in 2005), “Criteria for Nuclear Criticality Safety 

Controls in Operations With Shielding and Confinement,” American Nuclear Society, 

La Grange Park, Illinois, U.S.A.

66. ANSI/ANS-8.20-1991 (Reaffirmed in 2005), “Nuclear Criticality Safety Training,” 

American Nuclear Society, La Grange Park, Illinois, U.S.A.

67. ANSI/ANS-8.21-1995 (Reaffirmed in 2001), “Use of Fixed Neutron Absorbers in Nuclear 

Facilities Outside Reactors,” American Nuclear Society, La Grange Park, Illinois, U.S.A.

68. ANSI/ANS-8.23-2007, “Nuclear Criticality Accident Emergency Planning and Response,” 

American Nuclear Society, La Grange Park, Illinois, U.S.A.

69. ANSI/ANS-8.24-2007 (Reaffirmed in 2012), “Validation of Neutron Transport Methods for 

Nuclear Criticality Safety Calculations,” American Nuclear Society, La Grange Park, 

Illinois, U.S.A.

70. ANSI/ANS-8.26-2007, “Criticality Safety Engineer Training and Qualification Program,” 

American Nuclear Society, La Grange Park, Illinois, U.S.A.

71. IEEE Std 379-2000, “IEEE Standard Application of the Single-Failure Criterion to 

Nuclear Power Generating Station Safety Systems,” Institute of Electrical and 

Electronics Engineers, Piscataway, NJ, 2000. 

72. U.S. Nuclear Regulatory Commission, Regulatory Guide 1.53, “Application of the 

Single-Failure Criterion to Safety Systems,” November 2003, ADAMS Accession 

No. ML033220006. 

73. ASME N511, “Standard for In-Service Testing of Nuclear Air Treatment, Heating, 

Ventilating, and Air Conditioning Systems”

74. ASME AG-1-2009, “Code on Nuclear Air and Gas Treatment”

75. U.S. Nuclear Regulatory Commission, Regulatory Guide 3.71, Revision 2, “Nuclear 

Criticality Safety Standards for Fuels and Material Facilities,” December 2010, ADAMS 

Accession No. ML103210345. 

76. ANSI/ANS-8.19-2005, “Administrative Practices for Nuclear Criticality Safety,” American 

Nuclear Society, La Grange Park, Illinois, U.S.A.
Appendix B

B-7

77. U.S. Nuclear Regulatory Commission, NUREG/CR-6698, “Guide for Validation of 

Nuclear Criticality Safety Calculational Methodology,” January 2001 ADAMS Accession 

No. ML050250061.

78. U.S. Nuclear Regulatory Commission, “Control of Heavy Loads at Nuclear Power 

Plants,” NUREG-0612, July 1980, ADAMS Accession No. ML070250180. 

80. U.S. Nuclear Regulatory Commission, Regulatory Guide 8.2, “Guide for Administrative 

Practices in Radiation Monitoring,” Rev 1., May 2001, ADAMS Accession No. 

ML110460093.

81. U.S. Nuclear Regulatory Commission, Regulatory Guide 8.7, “Instructions for Recording 

and Reporting Occupational Radiation Exposure Data,” Rev. 2, November 2005, 

ADAMS Accession No. ML052970092.

82. U.S. Nuclear Regulatory Commission, Regulatory Guide 8.9, “Acceptable Concepts, 

Models, Equations, and Assumptions for a Bioassay Program,” July 1993, ADAMS 

Accession No. ML003739554.

83. U.S. Nuclear Regulatory Commission, Regulatory Guide 8.24, “Health Physics Surveys 

During Enriched Uranium-235 Processing and Fuel Fabrication,” Rev. 2, June 2012, 

ADAMS Accession No. ML110400305.

84. U.S. Nuclear Regulatory Commission, Regulatory Guide 8.34, “Monitoring Criteria and 

Methods To Calculate Occupational Radiation Doses,” July 1992, ADAMS Accession 

No. ML090770221.

85. U.S. Nuclear Regulatory Commission, Regulatory Guide 4.20, “Constraint on Releases 

of Airborne Radioactive Materials to the Environment for Licensees other than Power 

Reactors,” Rev. 1, April 2012, ADAMS Accession No. ML110120299.

86. U.S. Nuclear Regulatory Commission, Regulatory Guide 1.109, “Calculation of Annual 

Doses to Man from Routine Releases of Reactor Effluents for the Purpose of Evaluating 

Compliance with 10 CFR Part 50, Appendix I,” Rev. 1, October 1977, ADAMS Accession 

No. ML003740384.

87. U.S. Nuclear Regulatory Commission, Regulatory Guide 8.8, “Information Relevant to 

Maintaining Occupational Radiation Exposure as Low as Practicable (Nuclear 

Reactors),” July 1973, ADAMS Accession No. ML13350A229.

88. U.S. Nuclear Regulatory Commission, Regulatory Guide 8.10, “Operating Philosophy for 

Maintaining Occupational Radiation Exposures As Low As Practicable,” April 1974, 

ADAMS Accession No. ML13350A207.

89. Regulatory Issue Summary 2005-31, “Control of Security-Related Sensitive Unclassified 

Non-Safeguards Information Handled by Individuals, Firms, and Entities Subject to NRC 

Regulation of the Use of Source, Byproduct, and Special Nuclear Material,” December 

2005, ADAMS Accession No. ML053480073.
Appendix B

B-8

90. NUREG-1301, “Offsite Dose Calculation Manual Guidance: Standard Radiological 

Effluent Controls for Pressurized Water Reactors,” April 1991, ADAMS Accession 

No. ML091050061. 

91. U.S. Nuclear Regulatory Commission, Regulatory Guide 4.1, “Radiological 

Environmental Monitoring For Nuclear Power Plants,” Rev. 2, June 2009, ADAMS 

Accession No. ML091310141.

92. U.S. Nuclear Regulatory Commission, Regulatory Guide 4.15, “Quality Assurance for 

Radiological Monitoring Programs (Inception Through Normal Operations to License 

Termination)—Effluent Streams and the Environment,” Rev. 2, July 2007, ADAMS 

Accession No. ML071790506.

93. U.S. Nuclear Regulatory Commission, Regulatory Guide 1.143, “Design Guidance for 

Radioactive Waste Management Systems, Structures, and Components Installed in 

Light-Water-Cooled Nuclear Power Plants,” Rev. 2, November 2001, ADAMS Accession 

No. ML013100305.

94. NUREG/BR-0204, Rev. 2, “Instructions for Completing NRC’s Uniform Low-Level 

Radioactive Waste Manifest,” July 1998, ADAMS Accession No. ML071870172.

95. U.S. Nuclear Regulatory Commission, Information Notice No. 90-09, “Extended Interim 

Storage of Low Level Radioactive Waste by Fuel Cycle and Materials Licensees,” 

February 5, 1990. 

96. U.S. Nuclear Regulatory Commission, Regulatory Issue Summary 2008-12, 

“Considerations for Extended Interim Storage of Low-Level Radioactive Waste by Fuel 

Cycle and Materials Licensees,” May 9, 2008, ADAMS Accession No. ML073330725.

97. U.S. Nuclear Regulatory Commission, Regulatory Issue Summary 2011-09, “Available 

Resources Associated with Extended Storage of Low-Level Radioactive Waste,” 

August 16, 2011, ADAMS Accession No. ML111520042. 

98. U.S. Nuclear Regulatory Commission, Regulatory Guide 8.15, “Acceptable Programs 

For Respiratory Protection,” October 1976, ADAMS Accession No ML003739512. 

99. Letter SMT-2015-039 from SHINE Medical Technologies, Inc., “SHINE Medical 

Technologies, Inc. Application for Construction Permit Preliminary Safety Analysis 

Report Revisions,” dated August 27, 2015, ADAMS Accession No. ML15258A348.

100. Letter SMT-2015-046 from SHINE Medical Technologies, Inc., “Updated General 

Information for SHINE Medical Technologies, Inc.,” dated September 16, 2015, ADAMS 

Accession No. ML15259A272.

101. Letter SMT-2015-040 from SHINE Medical Technologies, Inc., “SHINE Medical 

Technologies, Inc. Application for Construction Permit Response to Request for 

Additional Information,” dated September 2, 2015, ADAMS Accession No. 

ML15247A067.
Appendix B

B-9

102. Letter from SHINE Medical Technologies, Inc., “SHINE Medical Technologies. Inc. 

Application for Construction Permit, SHINE Strategy for Extended Plant Shutdowns,” 

dated September 28, 2015, ADAMS Accession No. ML15271A314.

103. Letter from SHINE Medical Technologies, Inc., “SHINE Medical Technologies, Inc. 

Application for Construction Permit, SHINE-Definition of ‘Safety-Related Activities,’” 

dated September 28, 2015, ADAMS Accession No. ML15271A290.

104. Letter from SHINE Medical Technologies, Inc., “Updated Construction Permit 

Completion Dates for SHINE Medical Technologies, Inc.,” dated September 29, 2015, 

ADAMS Accession No. ML15272A395.

105. NUREG-2115, “Central and Eastern United States Seismic Source Characterization for 

Nuclear Facilities,” January 2012, ADAMS Accession No. ML12048A804.

106. American Concrete Institute Committee 349-06, “Code Requirements for Nuclear 

Safety-Related Concrete Structures,” American Concrete Institute, 2007.

C-1

APPENDIX C. PRINCIPAL CONTRIBUTORS

Name Chapter Area of Expertise

Adams, Mary 4, 9 Project Management

Alexander, Stephen 7, 8 Instrumentation and Controls

Atchison, John 5, 6, 9 Mechanical Engineering, 

Back, David 2 Seismic

Barss, Daniel 12 Emergency Preparedness

Bland, J. Stuart 7, 11 Radiation Protection

Boyle, Thomas 4, 13 Neutronics

Chapman, Gregory 6, 11 Radiation Protection, Criticality 

Safety

Cintron-Rivera, Jorge 8 Electrical Engineering

Downs, James 9 Fire Protection

Essig, Thomas 11 Radiation Protection

Gitnick, Mary T. Project Management

Gorden, Milton 2 Seismic

Guardiola, Maria 13 Chemical Safety

Hammelman, James 13 Chemical Safety

Harwell, Shawn 15 Financial Qualifications

Heysel, Christopher 6 Civil/Structural Engineering

Hofer, Gregory 3, 9, 14 Mechanical Engineering

Huckabay, Victoria 12 Quality Assurance

Lynch, Steven 1, 14 Project Management

Marschke, Stephen 2 Environmental Engineering

McIlvaine, James 11 Radiation Protection

Mlynarczyk, Diane 12 Quality Assurance

Morrissey, Kevin 6, 13 Accident Analysis

Munson, Jeremy 6 Criticality Safety

Prescott, Paul 12 Quality Assurance

Rodriguez, Michael 12 Emergency Preparedness

Salay, Michael 4, 13 Accident Analysis

Skarda, J. Raymond 4, 13 Thermal Fluids, Neutronics

Sherbini, Sami 13 Dose Analysis

Smith, Jim 4, 9, 13 Radiation Protection

Soto-Lugo, Soly 12 Quality Assurance

Staudenmeier, Joseph 4, 13 Thermal Fluids, Neutronics

Tripp, Christopher 6 Criticality Safety

Tuttle, Glenn 12 Material Control and Accounting

Vollert, Frank 3 Civil Engineering

Weitzberg, Abe 5, 7 Thermal Hydraulics, Neutronics

Zaki, Tarek 4, 13 Project Management

D-1

APPENDIX D. REPORT BY THE ADVISORY COMMITTEE ON 

REACTOR SAFEGUARDS
Appendix D

D-2
Appendix D

D-3
Appendix D

D-4
Appendix D

D-5





NUREG-2189 Safety Evaluation Report Related to SHINE Medical Technologies, Inc. 

Construction Permit Application for a Medical Radioisotope Production Facility