ML17305A685

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Draft Nwmi SER Appendix B
ML17305A685
Person / Time
Site: Northwest Medical Isotopes
Issue date: 11/01/2017
From:
Research and Test Reactors Licensing Projects Branch
To:
Helvenston E, NRR/DLP, 415-4067
Shared Package
ML17305A657 List:
References
Download: ML17305A685 (9)
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Text

APPENDIX B. REFERENCES

1. Letter NWMI-LTR-2015-003, from Northwest Medical Isotopes, LLC, Re: NRC Project No. 0803 - Northwest Medical Isotopes, LLC, Submittal Part 1 Construction Permit Application For A Radioisotope Production Facility - Withdrawal of Part 1 Application Submitted On November 7, 2014 and Resubmittal of Application, dated February 5, 2015, Agencywide Documents Access and Management System (ADAMS)

Accession No. ML15086A262, ADAMS Package No. ML15086A261.

2. Letter NWMI-LTR-2015-006, from Northwest Medical Isotopes, LLC, Re: NRC Project No. 0803 - Northwest Medical Isotopes, LLC, Submittal Part 2 Construction Permit Application for a Radioisotope Production Facility, dated July 20, 2015, ADAMS Accession No. ML15210A114.
3. Northwest Medical Isotopes, LLC, NRC Project No. 0803 - Northwest Medical Isotopes, LLC, Submittal Part 2 Construction Permit Application for a Radioisotope Production Facility, dated July 20, 2015, ADAMS Package Accession No. ML15210A182.
4. Letter NWMI-LTR-007 from Northwest Medical Isotopes, LLC, Re: Request For Exemption To Submit A Construction Permit Application In Two Parts As Described In 10 CFR 2.101 By Northwest Medical Isotopes, LLC, dated August 9, 2013, ADAMS Accession No. ML13227A295.
5. Letter from U.S. Nuclear Regulatory Commission (S. Lynch), to Northwest Medical Isotopes, LLC, Acceptance Letter for Northwest Medical Isotopes, LLC Regarding Request for Exemption from the Requirements of 10 CFR 2.101(a), dated August 22, 2013, ADAMS Accession No. ML13238A034.
6. Letter from U.S. Nuclear Regulatory Commission, to Northwest Medical Isotopes, LLC, Northwest Medical Isotopes, LLC - Acceptance For Docketing of Part One of The Application For Construction Permit (TAC No. MF6135), dated June 1, 2015, ADAMS Accession No. ML15125A048.
7. Letter from U.S. Nuclear Regulatory Commission, to Northwest Medical Isotopes, LLC, Northwest Medical Isotopes, LLC - Acceptance for Docketing of Part Two of The Application for A Production Facility Construction Permit (TAC No. MF6138), dated December 24, 2015, ADAMS Accession No. ML15341A112.
8. 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.
9. 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.
10. 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.

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References

11. 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.

12. Letter from U.S. Nuclear Regulatory Commission, to Northwest Medical Isotopes, LLC, Northwest Medical Isotopes, LLC. - Request for Additional Information Regarding Application for Construction Permit (TAC Nos. MF6135 and MF6138) and NRC Staff Review Schedule, dated March 28, 2016, ADAMS Accession No. ML16056A122.
13. Letter from U.S. Nuclear Regulatory Commission, to Northwest Medical Isotopes, LLC, Northwest Medical Isotopes, LLC - Request for Additional Information Regarding Application for Construction Permit (TAC No. MF6138), dated September 29, 2016, ADAMS Accession No. ML16236A013.
14. Letter from U.S. Nuclear Regulatory Commission, to Northwest Medical Isotopes, LLC, Northwest Medical Isotopes, LLC - Request for Additional Information for Construction Permit Application Regarding Emergency Response Plan (TAC No. MF6138), dated January 25, 2017, ADAMS Accession No. ML17013A584.
15. Letter from U.S. Nuclear Regulatory Commission, to Northwest Medical Isotopes, LLC, Northwest Medical Isotopes, LLC - Request For Additional Information Regarding Application For Construction Permit (TAC No. MF6138), dated March 29, 2017, ADAMS Accession No. ML17069A408.
16. Letter NWMI-LTR-2016-006 from Northwest Medical Isotopes, LLC, to U.S. Nuclear Regulatory Commission, RE: Docket No. 50-609. Northwest Medical Isotopes, LLC Responses to the U.S. Nuclear Regulatory Commission Environmental Request for Additional information - Letter Dated March 28, 2016, dated April 25, 2016, ADAMS Accession No. ML16123A119.
17. Letter NWMI-LTR-2016-012, from Northwest Medical Isotopes, LLC, RE:

Docket No. 50-609, Northwest Medical Isotopes, LLC Responses to the U.S. Nuclear Regulatory Commission Regarding the Preliminary Safety Analysis Report Request for Additional information (Letter dated September 29, 2016) (TAC No. MF6138), dated November 28, 2016, ADAMS Accession No. ML16344A052, ADAMS Package No. ML16344A049.

18. NWMI-LTR-2017-001, from Northwest Medical Isotopes, LLC, RE: Docket No. 50-609, Northwest Medical Isotopes, LLC Responses to the U.S. Nuclear Regulatory Commission Environmental Request for Additional information - Letter Dated January 25, 2017, dated March 6, 2017, ADAMS Accession No. ML17093A661
19. Letter NWMI-LTR-2017-002, from Northwest Medical Isotopes, LLC, RE: Docket No. 50-609, Northwest Medical Isotopes, LLC Responses to the U.S. Nuclear Regulatory Commission Environmental Request for Additional information - Letter Dated January 25, 2017, dated April 28, 2017, ADAMS Accession No. ML17128A065.

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References

20. Letter NWMI-LTR-2017-003, from Northwest Medical Isotopes, LLC, RE: Docket No.

50-609, Northwest Medical Isotopes, LLC Response to the U.S. Nuclear Regulatory Commission Regarding the Northwest Medical Isotopes, LLC - Request for Additional Information Regarding Application for Construction Permit (Letter dated March 29, 2017)

(TAC No. MF6138), dated April 28, 2017, ADAMS Accession No. ML17128A066, ADAMS Package No. ML17128A053.

21. Advisory Committee on Reactor Safeguards, Northwest Medical Isotopes Subcommittee, Transcript of Advisory Committee on Reactor Safeguards Northwest Medical Isotopes Subcommittee Meeting - July 11, 2017, dated July 11, 2017, ADAMS Accession No. ML17208A865.
22. U.S. Nuclear Regulatory Commission, NUREG-2209, Final Environmental Impact Statement for the Construction Permit for the Northwest Medical Isotopes Radioisotope Production Facility, dated May 31, 2017, ADAMS Accession No. ML17130A862.
23. Nuclear Waste Policy Act of 1982, Public Law No.97-425, 96 Stat. 2201, January 7, 1983.
24. 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.
25. 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.
26. U.S. Nuclear Regulatory Commission, Regulatory Guide 0800, Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR [light-water reactor] Edition, March 9, 2010, ADAMS Accession No.ML100331298.
27. U.S. Department of Energy, Accident Analysis for Aircraft Crash into Hazardous Facilities, DOE-STD-3014-96, October 1996, Reaffirmed May 2006.
28. Terracon, 2011, Preliminary Geotechnical Engineering Report Discovery Ridge-Certified Site Program Lots 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18, Trabue, Hansen

& Hinshaw, Inc. and Terracon Project No. 09105094.1, February 11, 2011.

29. American Society of Civil Engineers. Minimum Design Loads and Associated Criteria for Buildings and Other Structures, ASCE/SEI 7-16, 2016 Edition, Reston, VA.
30. ANSI/ANS-8.1-2014, Nuclear Criticality Safety in Operations with Fissionable Materials Outside Reactors, American Nuclear Society, La Grange Park, Illinois, U.S.A.
31. Attachment 3 to Letter NWMI-LTR-2016-012, from Northwest Medical Isotopes, LLC, Response to the U.S. Nuclear Regulatory Commission Request for Additional Information Regarding the Preliminary Safety Analysis Report and Environmental Review of the Northwest Medical Isotopes, LLC Construction Permit Application Docket No. 50-609 Dated: September 29, 2016 (Document No. NWMl-2016-RAl-004, November 2016) Public Version, dated November 28, 2016, ADAMS Accession No. ML16344A053.

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References

32. 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.
33. ANSI/ANS-8.3-1997 (Reaffirmed in 2012), Criticality Accident Alarm System, American Nuclear Society, La Grange Park, Illinois, U.S.A.
34. 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.
35. ANSI/ANS-8.10-2015, Criteria for Nuclear Criticality Safety Controls in Operations With Shielding and Confinement, American Nuclear Society, La Grange Park, Illinois, U.S.A.
36. ANSI/ANS-8.19-2014, Administrative Practices for Nuclear Criticality Safety, American Nuclear Society, La Grange Park, Illinois, U.S.A.

37 ANSI/ANS-8.20-1991 (Reaffirmed in 2015), Nuclear Criticality Safety Training, American Nuclear Society, La Grange Park, Illinois, U.S.A.

38. ANSI/ANS-8.22-1997 (Reaffirmed in 2016), Nuclear Criticality Safety Based on Limiting and Controlling Moderators, American Nuclear Society, La Grange Park, Illinois, U.S.A.
39. ANSI/ANS-8.23-2007 (Reaffirmed in 2012), Nuclear Criticality Accident Emergency Planning and Response, American Nuclear Society, La Grange Park, Illinois, U.S.A.
40. ANSI/ANS-8.24-2007, (Reaffirmed 2012) Validation of Neutron Transport Methods for Nuclear Criticality Safety Calculations, American Nuclear Society, La Grange Park, Illinois, U.S.A.
41. ANSI/ANS-8.26-2007 (Reaffirmed in 2016), Criticality Safety Engineer Training and Qualification Program, American Nuclear Society, La Grange Park, Illinois, U.S.A.
42. EPA 520/1-89-003, Users Guide for COMPLY Code, Revision 2, U.S. Environmental Protection Agency, Washington, DC, October 1989.
43. ANSI/ANS-15.1-2007 (Reaffirmed in 2013), The Development of Technical Specifications for Research Reactors.
44. ANSI/ANS-15.4-2016, Selection and Training of Personnel for Research Reactors, American National Standards Institute/American Nuclear Society, La Grange Park, Illinois, 2009.
45. ANSI/ANS-15.8-1995 (Reaffirmed in 2013), Quality Assurance Program Requirements for Research Reactors.
46. NWMI-2013-CALC-011, Source Term Calculations, Revision A, Northwest Medical Isotopes, LLC, Corvallis, Oregon, February 2015.
47. Regulatory Guide 4.21, Minimization of Contaminated and Radioactive Waste Generation: Life Cycle Planning, June 2008, ML080500187.

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References

48. NWMI-2015-CSE-008 Attachment C to, Northwest Medical Isotopes, LLC - Response to the U.S. Nuclear Regulatory Commission Regarding the Preliminary Safety Analysis Report Request For Additional Information (TAC No. MF6138), dated December 19, 2016, ADAMS Package Accession No. ML16344A049.
49. Northwest Medical Isotopes, LLC, Transmittal of Revision 2 of NWMI-2014-RPT-006, MCNP 6.1 Validations with Continuous Energy ENDF/B-VIL.1 Cross-Sections, dated June 2, 2017, ADAMS Accession No. ML17157B411.
50. U.S. Nuclear Regulatory Commission, NUREG/CR-6361, Criticality Benchmark Guide for Light-Water-Reactor Fuel in Transportation and Storage Packages.
51. U.S. Nuclear Regulatory Commission, NUREG/CR-6698, Guide for Validation of Nuclear Criticality Safety Calculational Methodology, January 2001, ADAMS Accession No. ML050250061.
52. International Handbook of Evaluated Criticality Safety Benchmark Experiments, Organization for Economic Cooperation and Development/Nuclear Energy Agency (OECD/NEA), December 2016.
53. FCSS-ISG-10, Justification for Minimum Margin of Subcriticality for Safety, USNRC, Washington DC, June 2006.
54. NWMI-2015-CRITCALC-006, Hot Cell Tank Pit, Revision A, Northwest Medical Isotopes, LLC, Corvallis, Oregon, 2015.
55. Letter NWMI-LTR-2017-011 from Northwest Medical Isotopes, LLC, to U.S. Nuclear Regulatory Commission, RE: Docket No. 50-609, Northeast Medical Isotopes, LLC, Transmittal of Revision 1 of Chapters 10.0, 11.0, 12.0 (including Appendices 12A, 12b, and 12C) and 14.0 and Revision 2 of Chapters 2.0, 3.0, 6.0, 7.0, 8.0, and 13.0 of NWMl-2013-021, Construction Permit Application for Radioisotope Production, dated August 7, 2018, ADAMS Accession No. ML17221A199, ADAMS Package No. ML17221A370.
56. Attachment 3 to NWMI-2013-021, Rev. 2, Chapter 13.0 - Accident Analysis Construction Permit Application for Radioisotope Production Facility and Chapter 14.0 -

Technical Specifications, dated August 5, 2017, ADAMS Accession No. ML17221A203.

57. Northwest Medical Isotopes, LLC, Response to the U.S. Nuclear Regulatory Commission Request for Additional Information Regarding the Preliminary Safety Analysis Report and Environmental Review, dated November 28, 2016, ADAMS Accession No. ML16344A053.
58. Northwest Medical Isotopes, LLC, NWMI-2017-RAI-002, Rev. 0, Response to the U.S.

Nuclear Regulatory Commission Northwest Medical Isotopes, LLC - Request for Additional Information Regarding Application for Construction Permit (TAC No. MF6138), dated April 28, 2017, ADAMS Accession No. ML17128A067.

59. ANSI/ANS-15.11-2016, Radiation Protection at Research Reactors, American Nuclear Society, La Grange Park, Illinois, 2009.

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References

60. Letter NWMI-LTR-2017-012 from Northwest Medical Isotopes, LLC, to U.S. Nuclear Regulatory Commission, RE: Docket No. 50-609, Northwest Medical Isotopes, LLC, Transmittal of Revision 3 of Chapters 1.0 through 18.0 of NWMl-2013-021, Construction Permit Application for Radioisotope Production, dated September 8, 2017, ADAMS Accession No. ML17257A021, ADAMS Package No. ML17257A019.
61. Letter from U.S. Nuclear Regulatory Commission, to Northwest Medical Isotopes, LLC, Northwest Medical Isotopes, LLC Request for Additional Information Regarding Application for Construction Permit (TAC No. MF6138), dated September 21, 2017, ADAMS Accession No. ML17262A111.
62. No Terracon, 2011, Preliminary Geo technical Engineering Report Discovery Ridge-Certified Site Program Lots 2, 5, 6, 7, 8, 9, JO, 11, 12, 13, 14, 15, 16, 17, and 18, Trabue, Hansen & Hinshaw, Inc. and Terracon Project No. 09105094.1, February 11, 2011.
63. Letter NWMI-LTR-2017-013, from Northwest Medical Isotopes, LLC, to U.S. Nuclear Regulatory Commission, RE: Responses to Advisory Committee on Reactor Safeguard Questions on Docket No. 50-609, Northwest Medical Isotopes, LLC, NWMI-2013-021, Construction Permit Application/or Radioisotope Production, at Meetings on June 19, 2017; July 11, 2017; and August 22 and 23,2017, dated September 18, 2017 ADAMS Accession No. ML17265A048.
64. Letter NWMI-LTR-2017-014, Revision 1 from Northwest Medical Isotopes, LLC, to U.S.

Nuclear Regulatory Commission, RE: Northwest Medical Isotopes, LLC Response to U.S. Nuclear Regulatory Commission Request for Additional Information Regarding Application for Construction Permit (TAC No. MF6138), Docket No. 50-609, dated September 18, 2017, dated September 28, 2017 ADAMS Accession No. ML17283A109.

65. Letter NWMI-LTR-2017-015 from Northwest Medical Isotopes, LLC, to U.S. Nuclear Regulatory Commission, RE: Responses to Advisory Committee on Reactor Safeguards Questions on Docket No. 50..609, Northwest Medical Isotopes, LLC, NWMl-2013-021, Construction Permit Application for Radioisotope Production, at Meeting on September 21, 2017, dated September 28, 2017, ADAMS Accession No. ML17283A108
66. U.S. Nuclear Regulatory Commission, Regulatory Guide 4.1, Radiological Environmental Monitoring For Nuclear Power Plants, Revision 2, June 2009, ADAMS Accession No. ML091310141.
67. Letter NWMI-LTR-2015-006, from Northwest Medical Isotopes, LLC, Attachment 3-Northwest Medical Isotopes, LLC - Part Two, Construction Permit Application, General Information per 10 CFR 50.33, Filing Free Required by 10 CFR 50.30(e) and 10 CFR 170.21, Classified Information Agreement per 10 CFR 50.37, and Chapter 1, July 2015, ADAMS Package No. ML15210A182.
68. 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, Revision 1, April 2012, ADAMS Accession No. ML110120299.

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References

69. U.S. Nuclear Regulatory Commission, Regulatory Guide 8.13, Instruction Concerning Prenatal Radiation Exposure, U.S. Nuclear Regulatory Commission, June 1999, ADAMS Accession No. ML003739505.
70. 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.
71. U.S. Nuclear Regulatory Commission, Regulatory Guide 8.2, Administrative Practices in Radiation Monitoring Surveys and Monitoring, Revision 1, May 2001, ADAMS Accession No. ML110460093.
72. NWMI-2013-CALC-006, Overall Summary Material Balance - MURR Target Batch, Rev. D, Northwest Medical Isotopes, LLC, Corvallis, Oregon, 2015.
73. U.S. Nuclear Regulatory Commission, Regulatory Guide 8.25, Air Sampling in the Workplace, Revision 1 June 1992, ADAMS Accession No. ML003739616.
74. U.S. Nuclear Regulatory Commission, Regulatory Guide 8.29, Instruction Concerning Risks from Occupational Radiation Exposure, Revision 1 February 1996, ADAMS Accession No. ML003739438.
75. U.S. Nuclear Regulatory Commission, Regulatory Guide 8.34, Monitoring Criteria and Methods to Calculate Occupational Radiation Doses, July 1992, ADAMS Accession No. ML090770221.
76. U.S. Nuclear Regulatory Commission Regulatory Guide 8.37, ALARA Levels for Effluents from Materials Facilities, July 1993, ADAMS Accession No. ML003739553.
77. U.S. Nuclear Regulatory Commission Regulatory Guide 8.4, Personnel Monitoring Devices - Direct Reading Pocket Dosimeter, June 2011, ADAMS Accession No. ML101900087.
78. U.S. Nuclear Regulatory Commission, Regulatory Guide 8.7, Instructions for Recording and Reporting Occupational Radiation Dose Data, Revision 2, November 2005, ADAMS Accession No. ML052970092.
79. 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.
80. 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.
81. U.S. Nuclear Regulatory Commission, Regulatory Guide 8.10, Operating Philosophy for Maintaining Occupational Radiation Exposure As Low As Reasonable Achievable, April 1974, ADAMS Accession No. ML13350A207.

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References

82. ANSI N13.1-2011, Sampling and Monitoring Releases of Airborne Radioactive Substances from the Stacks and Ducts of Nuclear Facilities, Health Physics Society, McLean, Virginia, March 2011.
83. ANSI N13.6-2010, Practice for Occupations Radiation Exposure Records Systems, Health Physics Society, McLean, Virginia, August 2010.
84. ANSI N13.11-2009, Personnel Dosimetry Performance - Criteria for Testing, Health Physics Society, McLean, Virginia, January 2009.
85. ANSI N13.27-1981, Performance Requirements for Pocket-Sized Alarm Dosimeters and Alarm Ratemeters, Health Physics Society, McLean, Virginia, April 1981.
86. ANSI N323C-2009, Radiation Protection Instrumentation Testing and Calibration - Air Monitoring Instruments, Institute of Electrical and Electronic Engineers, New York, New York, November 2009.
87. ANSI N13.22, Bioassay Programs for Uranium, Health Physics Society, McLean, Virginia, October 1995.
88. ANSI N13.30, Performance Criteria for Radiobioassay, Health Physics Society, McLean, Virginia, December 2011.
89. ANSI Z-88.2, American National Standard for Respiratory Protection, Revision 15, American National Standards Institute, New York, New York, 2015.
90. CGA G-7, Compressed Air for Human Respiration, Compressed Gas Association, Chantilly, Virginia, October 2011.
91. ASTM E1168-95, Standard Guide for Radiological Protection Training for Nuclear Facility Workers, ASTM International, West Conshohoken, Pennsylvania (R2013).
92. NUREG-1301, Offsite Dose Calculation Manual Guidance: Standard Radiological Effluent Controls for Pressurized Water Reactors, April 1991, ADAMS Accession No. ML091050061.
93. U.S. Nuclear Regulatory Commission, NUREG-1400, Air Sampling in the Workplace, September 1993, ADAMS Accession No. ML13051A671.
94. CGA G-7.1, Commodity Specification for Air, Compressed Gas Association, Chantilly, Virginia, October 2011.
95. U.S. Nuclear Regulatory Commission, Regulatory Guide 2.5, Quality Assurance Program Requirements for Research and Test Reactors, ADAMS Accession No. ML093520099.
96. ANSI/ANS-15.16-2015, Emergency Planning for Research Reactors, American Nuclear Society, La Grange Park, Illinois, U.S.A.

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References

97. U.S. Nuclear Regulatory Commission, Regulatory Guide 2.6, Emergency Planning For Research and Test Reactors and Other Non-Power Production and Utilization Facilities, Revision 2, September 2017, ADAMS Accession No. ML17263A472.
98. U.S. Nuclear Regulatory Commission, Regulatory Guide 1.60, Design Response Spectra for Seismic Design of Nuclear Power Plants, Revision 2, July 2014, ADAMS Accession No. ML13210A432.

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