ML23229A227

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Response to SRM-M230814 - Rulemaking - Final Rule - Comment Response Document - Emergency Preparedness for Small Modular Reactors and Other New Technologies
ML23229A227
Person / Time
Issue date: 11/09/2023
From:
Office of Nuclear Material Safety and Safeguards, Office of Nuclear Security and Incident Response
To:
References
NRC-2015-0225, EP SMR ONT, SRM-M230814, RIN 3150-AJ68
Download: ML23229A227 (178)


Text

NRC Response to Public Comments Emergency Preparedness for Small Modular Reactors and Other New Technologies NRC-2015-0225; 3150-AJ68 U.S. Nuclear Regulatory Commission Office of Nuclear Reactor Regulation Office of Nuclear Safety and Incident Response Office of Nuclear Material Safety and Safeguards November 2023

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Abbreviations and Acronyms ACRS Advisory Committee on Reactor Safeguards ADAMS Agencywide Documents Access and Management System AEA Atomic Energy Act of 1954, as amended APA Administrative Procedure Act BDBA beyond-design-basis accident BEIR Biological Effects of Ionizing Radiation (report)

BWR boiling-water reactor CFR Code of Federal Regulations COL combined license (combined construction and operating license)

CPG Comprehensive Preparedness Guide DBA design-basis accident DG draft regulatory guide DOE U.S. Department of Energy EAL emergency action level EP emergency preparedness EPA U.S. Environmental Protection Agency EPZ emergency planning zone ERO emergency response organization ESP early site permit ETE evacuation time estimate FDA U.S. Food and Drug Administration FEMA Federal Emergency Management Agency FIOP Federal Interagency Operational Plan FR Federal Register FRMAC Federal Radiological Monitoring and Assessment Center FRN Federal Register notice GSR general safety requirements IAEA International Atomic Energy Agency IPZ ingestion pathway emergency planning zone ISFSI independent spent fuel storage installation KI potassium iodide LLWR large light-water reactor LNT linear no-threshold LOCA loss-of-coolant accident LWR light-water reactor MACCS MELCOR Accident Consequence Code System mSv millisievert MW megawatt(s)

MW(e) megawatt(s) electric MW(t) megawatt(s) thermal NARAC National Atmospheric Release Advisory Center NEI Nuclear Energy Institute ii

NEIMA Nuclear Energy Innovation and Modernization Act NEPA National Environmental Policy Act non-LWR non-light-water reactor NNSA National Nuclear Security Administration NPUF non-power production or utilization facility NRC U.S. Nuclear Regulatory Commission NRF National Response Framework NRIA Nuclear/Radiological Incident Annex NUREG U.S. Nuclear Regulatory Commission technical report designation OL operating license ONT other new technology ORO offsite response organization PAA Price-Anderson Act PAG protective action guide PRA probabilistic risk assessment RA regulatory analysis RG regulatory guide ROP Reactor Oversight Process RTR research and test reactor SAR safety analysis report SFR sodium-cooled fast reactor SMR small modular reactor SOC statement of considerations SPR Stakeholder Preparedness Review SRM staff requirements memorandum TEDE total effective dose equivalent THIRA Threat and Hazard Identification and Risk Assessment iii

Table of Contents Introduction ................................................................................................................................... 1 A. General Comments on the Proposed Rulemaking .............................................................. 10 B. New Performance-Based Emergency Preparedness Framework10 CFR 50.160(b)(1) .. 18 C. Hazard Analysis of Contiguous or Nearby Facilities10 CFR 50.160(b)(2)....................... 40 D. Scalable Approach for Determining the Plume Exposure Pathway Emergency Planning Zone Size10 CFR 50.160(b)(3) ....................................................................................... 46 E. Requirement To Describe Ingestion Response Planning10 CFR 50.160(b)(4) ............... 79 F. Implementation Schedule .................................................................................................... 85 G. Administrative and Clarifying Changes to the Regulations ................................................. 86 H. Scope of the Proposed Rule ............................................................................................... 89 I. Draft Regulatory Analysis .................................................................................................... 94 J. Information Collection ......................................................................................................... 97 K. Draft Environmental Assessment ........................................................................................ 97 L. Draft Regulatory Guide ....................................................................................................... 98 M. Requests for Extension of the Comment Period ............................................................... 113 N. Additional Comments on the Proposed Rule .................................................................... 114 O. Outside the Scope of the Rulemaking ............................................................................... 124 iv

U.S. NUCLEAR REGULATORY COMMISSION RESPONSE TO PUBLIC COMMENTS RECEIVED ON THE PROPOSED RULE EMERGENCY PREPAREDNESS FOR SMALL MODULAR REACTORS AND OTHER NEW TECHNOLOGIES Introduction This document presents the U.S. Nuclear Regulatory Commissions (NRCs) responses to written public comments received on the proposed rule, Emergency Preparedness for Small Modular Reactors and Other New Technologies, and draft Regulatory Guide (DG)-1350, Performance-Based Emergency Preparedness for Small Modular Reactors, Non-Light-Water Reactors, and Non-Power Production or Utilization Facilities. The NRC published the proposed rule and notice of DG-1350 in the Federal Register on May 12, 2020 (85 FR 28436), for public comment with a 75-day public comment period. On July 21, 2020 (85 FR 44025), the NRC extended the public comment period by an additional 60 days to allow more time for members of the public and other stakeholders to develop and submit their comments.

The NRCs proposed rule would adopt new alternative emergency preparedness (EP) requirements for small modular reactors (SMRs) and other new technologies (ONTs) such as non-light-water reactors (non-LWRs) and certain non-power production or utilization facilities (NPUFs). These alternative requirements would introduce a performance-based, technology-inclusive, risk-informed, and consequence-oriented approach to EP for SMRs and ONTs. The new alternative EP requirements would: (1) continue to provide reasonable assurance that adequate protective measures can and will be implemented by an SMR or ONT licensee, (2) promote regulatory stability, predictability, and clarity, (3) reduce requests for exemptions from EP requirements, (4) recognize advances in design and technological advancements embedded in design features, (5) credit safety enhancements in evolutionary and passive systems, and (6) credit the potential benefits of smaller sized reactors and non-LWRs associated with postulated accidents, including slower transient response times, and relatively small and slow release of fission products.

The proposed rule on EP for SMRs and ONTs and DG-1350 are available from the Federal e-Rulemaking Web site at https://www.regulations.gov/ (Docket ID No. NRC-2015-0225) and through the NRCs Agencywide Documents Access and Management System (ADAMS)

(Accession Nos. ML20133J896 and ML18082A044, respectively).

In developing the final rule and supporting guidance,1 the NRC considered all the comments provided in response to the proposed rule. If, as a result of its review of a public comment, the NRC changed the rule, the supporting statement of considerations (SOC), or the supporting guidance, the NRCs response to the comment indicates where the change occurred.

Comment Overview The NRC received comments from 2,212 individuals and organizations, including 121 unique submissions, 2,087 form letters and form letters with non-substantive additional text, and 4 form 1 DG-1350 has been redesignated as Regulatory Guide (RG) 1.242, Performance-Based Emergency Preparedness for Small Modular Reactors, Non-Light-Water Reactors, and Non-Power Production or Utilization Facilities, issued XXXXXXX 2023 (ADAMS Accession No. ML23226A036).

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letters with additional substantive text. Table 1 identifies all unique submissions, Table 2 identifies form letter submissions, Table 3 identifies form letter submissions with non-substantive additional text, and Table 4 identifies form letter submissions with additional substantive text.2 The NRC reviewed and annotated the comment submissions to identify separate comments within each submission.3 Accordingly, a single submission may have several individual comments associated with it. The NRC gave each individual comment within a submission a unique identifier. The NRCs summaries include this unique identifier to identify which individual comments are addressed by each response.

Table 1. Unique Comment Submissions on EP for SMRs and ONTs Proposed Rule Submission Submission ADAMS Commenter Affiliation No. Abbreviation Accession No.

1 Adrian Egholm Private Citizen AE ML20135H055 2 Gary Hoe Private Citizen GHX ML20139A171 3 Chandra Perkins Private Citizen CPX ML20139A172 4 Tracy McLellan Private Citizen TMX ML20139A174 5 Alan Medsker Private Citizen AMX ML20139A175 6 Dr. Rita Baranwal U.S. Department of DOE1 ML20147A194 Energy (DOE) 7 Jill ZamEk San Luis Obispo SL1 ML20177A318 Mothers for Peace 8 Paul Laudeman Private Citizen PL ML20177A319 9 Sarah Fields Uranium Watch UW1 ML20199M274 10 Charity Colleen Crouse Private Citizen CCR ML20177A385 11 Randolph Sullivan Private Citizen RS ML20177A386 12 James Hopf Private Citizen JH ML20177A387 13 Anthony Devoe Private Citizen AD ML20177A388 14 Traber Schroeder Private Citizen TS ML20177A389 15 Billy Gogesch Private Citizen BGX ML20177A390 16 Robert Steinhaus Private Citizen RT ML20177A391 17 Nancy Bearg Private Citizen NB ML20177A396 18 Kevin and Pam Ward Private Citizen KPW ML20177A392 19 Mark Giese Private Citizen MG ML20177A393 20 Mark Weadick Private Citizen MW ML20177A394 21 Kimberly Mazik Private Citizen KM ML20177A395 22 Anonymous Private Citizen AN1 ML20177A426 23 Denisse B Private Citizen DBX ML20177A427 24 Tim Queeney Private Citizen TQ ML20177A428 25 Anonymous Private Citizen AN2 ML20178A154 26 Thomas McKenna Private Citizen TMY ML20191A271 30 Mitch McFarland Private Citizen MMX ML20192A283 77 Sherrill Futrell Private Citizen SF ML20192A279 2 Appendix A contains a table showing the individual submissions that were bundled together as form letter submissions.

3 The NRC compiled the annotated comment submissions into a single document which may be accessed within ADAMS using accession number ML21209A043.

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Submission Submission ADAMS Commenter Affiliation No. Abbreviation Accession No.

80 Jill ZamEk San Luis Obispo SL2 ML20196L638 Mothers for Peace 81 Bruce Musico Private Citizen BM ML20196L769 82 Dan Barss Private Citizen DBY ML20196L770 85 Herschel Specter Micro-Utilities, Inc. MU ML20202A532 92 Eleanor Dwight Private Citizen ED ML20204A854 97 Harry Kershner Private Citizen HK ML20204A859 U.S. DOE National 105 Jay Tilden Nuclear Security NNSA1 ML20209A069 Administration 111 Bobbie Flowers Private Citizen BF ML20204B021 116 Rebecca Ramsay Private Citizen RR ML20204B013 129 Kevin Callahan The Shoshone- SBT ML20209A425 Bannock Tribes 130 Eric Crews Private Citizen EC ML20209A426 131 Anonymous Private Citizen AN3 ML20209A427 132 Chanceton Ippolito Private Citizen CI ML20209A428 133 Suzanne Sorkin Private Citizen SSX ML20209A429 134 Anonymous Private Citizen AN4 ML20209A430 135 Karla Kelley Private Citizen KK ML20209A431 136 Georgia Morgan Private Citizen GM ML20209A432 137 Lisa Chapnick Private Citizen LC ML20209A420 138 Nora Moosnick Private Citizen NMY ML20209A421 139 Anonymous Private Citizen AN5 ML20209A422 140 Paul Gunter Beyond Nuclear BN ML20209A537 141 Naomi Private Citizen NA ML20211L783 142 Laurie Macintosh Private Citizen LMY ML20211L781 143 Adam Stein Private Citizen AS ML20211L782 144 Pete Gaynor FEMA FEMA ML20213C415 145 Joan Whittemore Private Citizen JW ML20216A404 146 Thomas Arruda Private Citizen TA ML20216A405 147 Thomas Deuring Private Citizen TD ML20216A406 148 Deborah Euerle Private Citizen DE ML20216A407 149 Philip Jensen Private Citizen PJ ML20216A408 150 Anonymous Private Citizen AN6 ML20216A409 151 Raymond Underberg Private Citizen RU ML20216A410 152 Bruce Hlodnicki Private Citizen BH2 ML20216A411 153 Lars Engstrom Private Citizen LEY ML20216A413 154 Geneva Lee Private Citizen GL ML20216A414 155 Mark Duane Private Citizen MDX ML20216A415 156 Barbara & Rob Private Citizen BRM ML20216A416 Matthews 157 Anonymous Private Citizen AN7 ML20216A417 158 Bradley Green Private Citizen BG ML20216A418 159 Dan Schmid Private Citizen DS ML20216A419 160 Taylor White Private Citizen TW ML20216A420 3

Submission Submission ADAMS Commenter Affiliation No. Abbreviation Accession No.

161 Charles Moldenhauer Private Citizen CMZ ML20216A421 162 David Johnson Private Citizen DJ ML20216A422 163 Michael Lyons Private Citizen ML ML20216A423 164 S. Spilman Private Citizen SSY ML20216A425 165 August Bramoff Private Citizen AB ML20216A426 166 William Seldon Private Citizen WSY ML20216A427 167 Lynn & Roger Stapes Private Citizen LRS ML20216A428 168 George Wolfe Private Citizen GW ML20216A429 169 Scott Bean Private Citizen SB ML20216A430 170 Francesca Private Citizen FM ML20216A432 Moldenhauer 171 Marla Dygert Private Citizen MDY ML20216A433 172 Austin Ouellette Private Citizen AO ML20216A434 173 Sean Holland Private Citizen SHY ML20216A435 174 John M Rathbun Private Citizen JR ML20216A424 175 Cory Casanave Private Citizen CCY ML20218A699 176 Von Froehlich Private Citizen VF ML20219A613 177 David Gluck Private Citizen DGY ML20220A523 178 28 nongovernmental Group Comment NGO ML20198M501 organizations 181 Nathan Roser Private Citizen NR ML20232D065 182 Charles Myers Private Citizen CMXA ML20233A681 Pennsylvania 183 David Lafleur Bureau of PBRP ML20238B975 Radiation Protection 184 Anonymous Private Citizen AN8 ML20239B007 186 Herschel Specter Micro-Utilities, Inc. MU2 ML20247J576 187 Matthew Rail Private Citizen MRY ML20252A210 188 Lee St. John Private Citizen LSY ML20253A136 189 Ren Dolnick Private Citizen RD ML20258A100 190 Daniel Farr Private Citizen DF ML20258A140 191 Karl Rabenhorst Private Citizen KR ML20266G313 192 Patrick Mulligan NJDEP NJDEP ML20267A328 193 Anonymous Private Citizen AN9 ML20267A325 194 Marcus Nichol Nuclear Energy NEICL, NELA ML20267A326 Institute 195 A. Gilbert Nuclear Innovation NIA ML20267A327 Alliance 196 Cyrus Afshar NuScale NSCL, NSA ML20268B269 197 Richard Schumacher Private Citizen RS ML20268B270 198 Katie Tubb The Heritage HF ML20269A250 Foundation 199 Kenneth Schrader Private Citizen KS ML20269A251 200 Nicholas McMurray ClearPath CPCL, CLA ML20269A252 201 Peter Lyons Nuclear Matters NM1, NM2 ML20269A253 202 Christopher Chwasz Private Citizen CC ML20269A254 4

Submission Submission ADAMS Commenter Affiliation No. Abbreviation Accession No.

Conference of 203 Kimberly Steves Radiation Control CRCPD ML20269A423 Program Directors, Inc.

U.S. DOE National 204 Dr. Rita Baranwal and NNSA2 ML20269A441 Nuclear Security Jay Tilden Administration 205 Heywood Williams Private Citizen HW ML20272A200 206 Leigh Ford Snake River SRA ML20272A201 Alliance, et al.

207 Margo & Dennis Proksa Private Citizen MDP ML20272A202 208 Ted Stout Private Citizen TSX ML20272A203 209 Angela Leek Iowa Department of IDPH ML20272A204 Public Health 210 Craig Piercy American Nuclear ANS ML20272A205 Society Union of 211 Edwin Lyman Concerned UCS, UCSJT ML20272A206 Scientists Nuclear Energy 212 Tansey Moore Tribal Working NETWG ML20272A207 Group 213 Theresa Kaufmann Private Citizen TKX ML20272A208 214 Sarah Fields Uranium Watch UW2, UWJB, ML20272A270 UWF1, UWF2 215 Ryan Bodolay Private Citizen RB ML20307A004 Table 2. Form Letter Comment Submissions on EP for SMRs and ONTs Proposed Rule Submission Submission ADAMS Commenter Affiliation No. Abbreviation Accession No.

NA Form Comments 1 NA FL1 ML20192A067 (1-500)

NA Form Comments 1 NA FL1 ML20192A079 (501-1,000)

NA Form Comments 1 NA FL1 ML20205L565 (1,001-1,500)

NA Form Comments 1 NA FL1 ML20211L855 (1,501-1,950)

NA Form Comments 1 NA FL1 ML20225A219 (1,951-1,959)

NA Form Comments 1 NA FL1 ML20240A274 (1,960-1,964)

NA Form Comments 1 NA FL1 ML20272A243 (1,965-1,971)

NA Form Comments 1 NA FL1 ML20290A748 (1,972)

Form Comments 1 NA NA FL1 ML20337A375 (1,973) 5

Submission Submission ADAMS Commenter Affiliation No. Abbreviation Accession No.

NA Form Comments 2 NA FL2 ML20272A286 (1-23) 61 Dr. F. Taylor Private Citizen FT ML20192A263 114 Mindy Maxwell Private Citizen MMY ML20204B011 NA Form Comments 1 NA FL1 ML21131A175 (1,974)

Table 3. Form Letter Comment Submissions with Nonsubstantive Additional Text on EP for SMRs and ONTs Proposed Rule Submission Submission ADAMS Commenter Affiliation No. Abbreviation Accession No.

27 Glen Anderson Private Citizen GA ML20192A280 28 Jeannette Bartelt Private Citizen JBX ML20192A281 29 Matthew Sheinin Private Citizen MS ML20192A282 31 Beth Jane Freeman Private Citizen BJF ML20192A284 32 Joseph Magid Private Citizen JM ML20192A285 33 Davis and Rhonda Private Citizen CMX ML20192A286 Costas-Mirza 34 Janice Hallman Private Citizen JHX ML20192A287 35 James Hadcroft Private Citizen JHY ML20192A288 36 Charlie Weaver Private Citizen CW ML20192A289 37 Jill McManus Private Citizen JMX ML20192A290 38 Jennifer Merritt Private Citizen JMY ML20192A291 39 Maxina Ventura Private Citizen MVX ML20192A292 40 Sara Hale Private Citizen SHX ML20192A293 41 Marjorie Oakes Private Citizen MO ML20192A294 42 Bron Lucas Private Citizen BL ML20192A295 43 Mary Ryan-Hotchkiss Private Citizen MR ML20192A296 44 Mark Meeks Private Citizen MMZ ML20192A297 45 Winthrop Southworth Private Citizen WSX ML20192A298 46 Sr. Linda M. Bessom Private Citizen LBX ML20192A299 47 Jef Schultz Private Citizen JSX ML20192A300 48 Felice Nord Private Citizen FN ML20192A301 49 Nancy Hiestand Private Citizen NH ML20192A302 50 Ned Flaherty Private Citizen NF ML20192A303 51 Linda Silversmith Private Citizen LS ML20192A304 52 Sandra Morey Private Citizen SM ML20192A305 55 Neal Steward Private Citizen NSY ML20192A308 56 Michael Marquardt Private Citizen MMA ML20192A258 57 Fred Oswald Private Citizen FO ML20192A259 58 Karen Bonime Private Citizen KB ML20192A260 59 Carol Creech Private Citizen CCX ML20192A261 60 L. Bagley Private Citizen LBY ML20192A262 62 Beverley Birks Private Citizen BB ML20192A264 6

Submission Submission ADAMS Commenter Affiliation No. Abbreviation Accession No.

63 Michael House Private Citizen MH ML20192A265 64 Bruce Hlodnicki Private Citizen BH1 ML20192A266 65 Gabrielle Hecht Private Citizen GHY ML20192A267 66 L. Watchempino Private Citizen LW ML20192A268 67 Patricia Reynolds Private Citizen PRY ML20192A269 68 Bobby Greg Private Citizen BGY ML20192A270 69 Carol Taccetta Private Citizen CT ML20192A271 70 Patty McGrath Private Citizen PMX ML20192A272 71 Steve Dickman Private Citizen SD ML20192A273 72 Virginia Smedberg Private Citizen VS ML20192A274 73 Chris Moore Private Citizen CMY ML20192A275 74 Rick Harlan Private Citizen RH ML20192A276 75 Erlynn Wallace Private Citizen EW ML20192A277 76 Carol Jagiello Private Citizen CJX ML20192A278 78 Jacquelyn Drechsler Private Citizen JD ML20195B143 79 Carol Jagiello Private Citizen CJY ML20195B144 83 Helen Dickey Private Citizen HD ML20197A196 84 Edith Griffin Private Citizen EG ML20199M273 86 Jean Blackwood Private Citizen JBY ML20204A848 87 Jeri Fergus Private Citizen JF ML20204A849 89 Dennis Vieira Private Citizen DV ML20204A851 90 Margaret Johnson Private Citizen MJ ML20204A852 91 Shannin Zevian Private Citizen SZ ML20204A853 93 Ann Ruthsdottir Private Citizen AR ML20204A855 94 Jean Farris Private Citizen JFX ML20204A856 95 T. Cassidy Private Citizen TC ML20204A857 96 Barbara Antonoplos Private Citizen BA ML20204A858 98 Naomi Zuckerman Private Citizen NZ ML20204A860 99 Leslie Potter Private Citizen LP ML20204A861 100 James Fuller Private Citizen JFY ML20204A862 101 Katie Harris Private Citizen KHX ML20204A863 102 Barrie Stebbings Private Citizen BS ML20204A864 103 Don McKelvey Private Citizen DM ML20204A865 104 Phyllis Miller Private Citizen PMY ML20204A846 106 Gail Payne Private Citizen GP ML20204B016 107 Deborah Reade Private Citizen DR ML20204B017 108 Ann Morgan Private Citizen AMY ML20204B018 109 Janice Gintzler Private Citizen JG ML20204B019 110 Jill Simon Private Citizen JSY ML20204B020 112 Donald Goldhamer Private Citizen DGX ML20204B022 113 Gina Zirtzman Private Citizen GZ ML20204B023 115 Tom Kennedy Private Citizen TK ML20204B012 117 Kay Cumbow Private Citizen KC ML20204B014 119 Randall Wayne Private Citizen RW ML20204B031 120 Fay Payton Private Citizen FP ML20205L569 7

Submission Submission ADAMS Commenter Affiliation No. Abbreviation Accession No.

121 Melvin Mackey Private Citizen MMB ML20205L570 122 Linda Marshall Private Citizen LMX ML20205L571 123 Leonard Eiger Private Citizen LEX ML20205L572 124 Wesley Banks Private Citizen WB ML20205L566 125 Dee Halzack Private Citizen DH ML20205L567 126 Kirsten Hopkins Private Citizen KHY ML20205L568 127 Marie Valleroy Private Citizen MVY ML20209A423 128 Karen Froiland Private Citizen KF ML20209A424 179 Harry Bryant Private Citizen HB ML20230A213 180 Cathy Lester Private Citizen CL ML20231A367 185 Shannin Zevian Private Citizen SZX ML20246G623 Table 4. Form Letter Comment Submissions with Substantive Additional Text on EP for SMRs and ONTs Proposed Rule Submission Submission ADAMS Commenter Affiliation No. Abbreviation Accession No.

53 Paul Roden Private Citizen PRX ML20192A306 54 Jerell Lambert Private Citizen JL ML20192A307 88 Patrick Conley Private Citizen PC ML20204A850 118 Fred Bergmann Private Citizen FB ML20204B015 Public Meeting On June 24, 2020, the NRC held a Category 3 public meeting virtually via WebEx to discuss the proposed rule with external stakeholders (see meeting summary at ADAMS Accession No. ML20196L775). The NRCs goal for conducting this meeting was to explain the proposed rule and supporting guidance and answer questions to enable stakeholders to provide informed comments on the proposed rule.

Comment Categorization This comment response document separates the comments into the 17 categories identified below. Within each category, the NRC summarizes comments and responds to the comments.

In general, the NRC addresses each individual comment. However, when similar comments can be readily grouped together, the NRC has binned those comments and treated them as a single comment. The NRCs response addresses the binned comments. The annotated comment number or numbers appear in a parenthetical list at the end of each comment summary to provide a cross-reference aid to the reader.

The comment summaries are grouped in the following categories:

A. General Comments on the Proposed Rulemaking B. New Performance-Based Emergency Preparedness Framework10 CFR 50.160(b)(1)

C. Hazard Analysis of Contiguous or Nearby Facilities10 CFR 50.160(b)(2) 8

D. Scalable Approach for Determining the Plume Exposure Pathway Emergency Planning Zone Size10 CFR 50.160(b)(3)

E. Requirement to Describe Ingestion Response Planning10 CFR 50.160(b)(4)

F. Implementation Schedule G. Administrative and Clarifying Changes to the Regulations H. Scope of the Proposed Rule I. Draft Regulatory Analysis J. Information Collection K. Draft Environmental Assessment L. Draft Regulatory Guide M. Requests for Extension of the Comment Period N. Additional Comments on the Proposed Rule O. Outside the Scope of the Rulemaking 9

A. General Comments on the Proposed Rulemaking General Comments in Support of the Proposed Rulemaking Comment A-1.1: Several commenters expressed support for the proposed rule, stating that the existing EP regulations for SMRs and ONTs are unnecessary, outdated, and do not account for advances in nuclear reactor technology. Several commenters stated that the proposed performance-based approach is necessary for the effective evaluation of new technological and safety advancements in SMR and ONT designs. Two commenters stated that current EP requirements are based on existing large light-water reactors (LLWRs) and are overly prescriptive for modern advanced reactor designs. One commenter wrote that the proposed rule exemplifies the NRCs ability to modernize regulations to account for innovative nuclear technologies. One commenter stated that the NRC should proceed with updating regulations for older reactors, which are safer than current rules would suggest. One commenter wrote that the rationale for existing EP regulations, and the decision to require a 10-mile plume exposure pathway emergency planning zone (EPZ) were guided by the spectrum of possible accidents from existing LLWR technology in 1978. According to the commenter, these regulations have remained unchanged, so the NRC should update EP regulations to meet the risk profile of advanced reactor technologies. (GHX-1, GHX-6, CI-1, TD-1, PJ-1, MDX-1, HF-2, CPCL-1, CLA-1, NM2-1, CRCPD-1, ANS-1)

NRC Response: The NRC agrees with the comments. The comments support the proposed rule and suggest no changes to the proposed rule.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment A-1.2: Several commenters, including a form letter campaign, expressed general support for the proposed rulemaking. The form letter campaign and one commenter expressed support for a performance-based, risk-informed, and consequence-oriented approach to emergency planning. (DS-1, CMZ-1, ML-1, WSY-1, NR-1, RSY-1, CLA-4, FL2-1)

NRC Response: The NRC agrees with the comments. The comments support the proposed rule and suggest no changes to the proposed rule.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment A-1.3: Several commenters wrote that modern SMRs are important to mitigating climate change, reducing greenhouse gas emissions, and lowering usage of carbon-intensive fuel. One commenter stated that after weighing the risks of modern nuclear technologies against global warming and fossil fuels, modern nuclear technologies are well worth the minimal risk they pose. One commenter wrote that the proposed rule would make construction of small reactors more financially feasible and, as a result, help reduce greenhouse gases. One commenter wrote that nuclear power is an important transition technology to cope with carbon emissions. One commenter wrote that nuclear power is critical to combatting climate change and ensuring that the United States is competitive in the nuclear industry. (TS-1, JR-1, KS-2, SHY-1, BG2-1, CCY-1, NM2-3)

NRC Response: The NRC agrees, in part, with the comments. The NRC agrees that it should proceed with the rulemaking. However, the promotion of nuclear power, for any reason, is not one of the purposes of this rulemaking nor is it permissible under the NRCs statutory authority.

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Accordingly, the NRC did not change the rule language in response to these comments.

Comment A-1.4: Several commenters stated that nuclear technology is safe and risks are overstated. Two commenters referenced the Three Mile Island or Fukushima incidents, writing that they were not representative of newer technology. Several commenters noted that the perception of nuclear technology is based on fear and that the public must be educated on the safety of nuclear reactors. One commenter wrote that modern small reactor designs feature state-of-the-art digital systems, passive safety features, and other modern characteristics that largely eliminate dangerous events. One commenter wrote that the likelihood that SMR facilities and other smaller reactors would require a massive evacuation is extremely small. (DJ-1, FM-1, CCY-2, NSCL-1, KS-1)

NRC Response: The NRC agrees, in part, with the comments. The NRC agrees that one goal of this rulemaking is to credit safety enhancements and the potential benefits of smaller sized reactors and non-LWRs associated with postulated accidents. However, notwithstanding whether the risks of nuclear technology are overstated, the NRCs mission is to license and regulate the Nations civilian use of radioactive materials to provide reasonable assurance of adequate protection of public health and safety, promote the common defense and security, and protect the environment. To fulfill this mission, the NRC evaluates the risks associated with commercial nuclear power technologies on a case-by-case basis. This rulemaking provides an EP framework built on that foundational principle.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment A-1.5: One commenter supported the performance-based, risk-informed framework and urged the NRC staff to apply this approach to other topics such as security or accident analysis. (ANS-9)

NRC Response: The NRC agrees, in part, with the comment. The agency is considering performance-based, risk-informed frameworks for some other domains, such as licensing advanced reactors. On a case-by-case basis, and as needed, the NRC will determine the value of adopting additional performance-based, risk-informed frameworks.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment A-1.6: A form letter campaign stated that the proposed requirements do not fully recognize microreactor safety. The commenters suggested that the NRC further refine its EP regulations and guidance to account for the inherent safety of advanced microreactors. (FL2-2, NR-2)

NRC Response: The NRC agrees, in part, with the comments. Microreactors may present accident consequences comparable to existing non-power reactors, which are already not subject to offsite emergency planning requirements. However, this rulemaking addresses EP for all advanced reactors, including microreactors. Both the rule and accompanying guidance are technology inclusive, which provides for the scope of EP to be scaled commensurate to the dose consequence risk for a facility on a case-specific basis and using design-specific and site-specific information. The NRC will consider addressing other microreactor regulations in other advanced reactor rulemaking efforts.

Accordingly, the NRC did not change the rule language in response to these comments.

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General Comments in Opposition to the Proposed Rulemaking Comment A-2.1: Several commenters stated that easing EP requirements will compromise public health and safety and proposed to maintain the existing EP protections. One commenter stated that the nuclear industry has a reckless disregard for public health and safety. One commenter urged the NRC not to put the safety of citizens in jeopardy. (NB-1, MG-1, AN2-1, LC-1, NMY-1, AN5-1, NA-1)

NRC Response: The NRC disagrees with the comments. The NRCs mission is to license and regulate the civilian use of radioactive materials to provide reasonable assurance of adequate protection of public health and safety, promote the common defense and security, and protect the environment. This rulemaking is consistent with the agencys mission. As explained in the NRC Response to Comment A-2.3, the NRC is not reducing EP requirements through this rulemaking. As explained in the NRC Response to Comment A-2.4, the final rules performance-based framework, the NRCs inspection and enforcement program, and the design-specific review process described in the rule provide reasonable assurance that protective actions can and will be taken in the event of a radiological emergency at a facility complying with the final rule.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment A-2.2: Several commenters suggested that the NRC evaluate new SMRs under the existing regulations to prove their safety. The commenters stated that once there is tangible evidence that SMRs are safe, then the NRC can move ahead with the proposed regulation.

One commenter stated that implementing SMRs without evaluating their deficiencies would be sacrificing the safety of the community for the sake of an experiment. Another commenter wrote that the nuclear industry has a poor reputation with the public, and evaluating new SMRs under the existing regulations first would reassure the public of SMR safety. One commenter said that new SMRs need to be tested under a variety of weather, geological, and social conditions before implementation. One commenter said that SMR facilities could potentially be safer, but none have been approved by the NRC, and there is no justification for reducing emergency planning requirements as a result. (AN6-1, JW-1, TA-1, RU-1, SSY-1, LRS-1, MDY-1, MRY-1, UWJB-1)

NRC Response: The NRC agrees, in part, with the comments. The NRC agrees that designers of new nuclear power reactors must prove the safety of their designs but disagrees that this is a reason to revise or postpone this rulemaking. Any reactor design is evaluated under the NRCs current regulations to determine the safety of the design. Under Title 10 of the Code of Federal Regulations (10 CFR) 50.43(e), the NRC will not approve a reactor design for nuclear power plants that differ significantly from evolutionary light-water reactors (LWRs) or that use simplified, inherent, passive, or other innovative means to accomplish their safety functions (i.e., advanced reactors), without the demonstration of the performance of their safety features through either analysis, appropriate test programs, experience, or a combination thereof. This requirement and others implement the Commissions policy on proof-of-performance testing for all advanced reactors (Regulation of Advanced Nuclear Power Plants; Statement of Policy (51 FR 24643, 24648; July 8, 1986)) and its goal of resolving all safety issues before authorizing construction (Licenses, Certificates, and Approvals for Nuclear Power Plants; Final Rule (72 FR 49351, 49566; August 28, 2007)).

This rulemaking acknowledges technological advancements and other differences from LLWRs that are inherent in SMRs and ONTs by, for example, crediting the potential benefits of smaller 12

sized reactors and non-LWRs associated with postulated accidents, including slower transient response times and relatively small and slow release of fission products.

Furthermore, not all current EP requirements apply to SMRs or ONTs. One of the purposes of this rulemaking is to establish an alternative EP framework that reduces the need for future applicants to seek exemptions from NRC regulations while providing the same level of EP as the current EP framework.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment A-2.3: Several commenters expressed opposition to the proposed rule, arguing that nuclear energy is dangerous, and the NRC should not ease associated safety regulations. Two commenters wrote that nuclear power is still too dangerous, and the country should investigate other sources of energy such as wind, solar, or hydroelectric power. Some commenters further stated that nuclear energy is a dirty energy and will harm the environment. One commenter wrote that small reactors are still dangerous and have no safe storage or decommissioning plan.

One commenter wrote with concern over the disposal of nuclear waste. One commenter stated that to promote the use of nuclear power is to vote in favor of the inevitable destruction of the environment. One commenter wrote that the proposed rule is designed to bolster theoretical certainty of SMR designs by claiming inherent safety and passive safety of designs and reinstate what the commenter describes as a false perception that the potential for a severe incident with significant offsite consequences is not mathematically credible. One commenter cited incidents such as Three Mile Island, Chernobyl, and Fukushima as evidence for the impact of accidents and wrote that the use of nuclear energy should be permanently ended. (TMX-1, PRX-1, JL-1, BN-1, BH2-1, LEY-1, AB-1, LSY-1, RD-1, RD-2, HW-1)

NRC Response: The NRC disagrees with the comments. Congress authorized the NRC to license and regulate the civilian use of radioactive materials to provide reasonable assurance of adequate protection of public health and safety. Whether the Nation should pursue other sources of energy is beyond the NRCs authority. Further, the NRC is not reducing safety regulations through this rulemaking. The dose criteria under which predetermined, prompt protective actions (e.g., evacuation, sheltering in place) would be taken are the same under the EP requirements in 10 CFR 50.47(b) and Appendix E, Emergency planning and preparedness for production and utilization facilities, to 10 CFR Part 50, Domestic licensing of production and utilization facilities, and the alternative EP requirements of 10 CFR 50.160, Emergency preparedness for small modular reactors, non-light water reactors, and non-power production or utilization facilities. Therefore, the level of EP is the same under both EP frameworks. Also, the reactor core sizes in SMRs and ONTs are expected to be smaller than those in currently operating LLWRs and are associated with lower power densities, lower probabilities of severe accidents, slower accident progression, and smaller offsite accident consequences per module.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment A-2.4: Several commenters, including a form letter campaign, expressed general opposition to reducing EP requirements. One commenter stated that it is irresponsible to shrink the containment area around nuclear facilities, arguing that the current pandemic is a perfect example of the Government facing significant consequences for disregarding safety standards.

One commenter criticized reduction in EP planning standards, arguing that this is an unnecessary change and that EP needs to be at its most stringent after the past failures of nuclear facilities. The commenter also emphasized the importance of the Federal Emergency Management Agency (FEMA) in EP planning. (AN1-1, MMX-1, ED-1, TSX-1, FL1-1) 13

NRC Response: The NRC disagrees with the comments. The NRC is not reducing its emergency planning standards. The dose criteria under which predetermined, prompt protective actions (e.g., evacuation, sheltering in place) would be taken is the same under the EP requirements in 10 CFR 50.47(b) and Appendix E to 10 CFR Part 50 and the alternative EP requirements of 10 CFR 50.160. Therefore, the level of EP is the same under both EP frameworks.

The final rules performance-based approach to EP provides reasonable assurance of adequate protection of the public health and safety through NRC review of design-specific and site-specific analyses to support a proposed plume exposure pathway EPZ size, review of site-specific emergency plans to ensure compliance, demonstration of emergency response capabilities through drills and exercises by applicants and licensees, analysis of potential hazards, and the NRCs inspection and enforcement program. Additionally, reasonable assurance is also based on the NRCs review of FEMA findings and determination as to whether State, local, and participating Tribal governmental entities emergency plans are adequate, except in cases where plume exposure pathway EPZs do not extend beyond the site boundary. However, not requiring offsite planning activities for facilities with plume exposure pathway EPZs at the site boundary in no way affects the authority that FEMA has for overall emergency management and assistance to Tribal, State, and local response organizations.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment A-2.5: Several commenters expressed concern that the NRC is not fulfilling its duty of protecting the public. One commenter wrote that, instead, the NRC is looking out for the financial interests of the nuclear industry and criticized what the commenter described as a reduction in EP requirements after the Fukushima and Chernobyl accidents. One commenter said that independent safety reviews are a key feature of the NRC, and the proposed rule just falls back on industry knows besta denial of the NRCs core purpose. One commenter called reduced EP regulations for smaller reactors irresponsible and dangerous. Another commenter criticized the proposed rule as fundamentally flawed and technically unsound, writing that it would be inappropriate to allow any facility within the scope of the rule to utilize reduced EP standards. The commenter also wrote that the rule would undermine the NRCs credibility as an independent regulator looking out for the public interest. (PC-1, FB-1, AN7-1, UCS-1)

NRC Response: The NRC agrees, in part, with the comments. As explained in the NRC Response to Comment A-2.3, the NRC is not reducing EP regulations through this rulemaking.

Further, the NRC has a history of successfully implementing performance-based EP standards.

For example, the NRC applies a graded approach to EP for research and test reactors (RTRs).

The NRC agrees that independent safety reviews are fundamental to how the agency regulates.

As explained in the NRC Responses to Comments D-1.3 and D-2.1, the NRC will perform independent safety reviews under the final rule.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment A-2.6: Several commenters and a form letter campaign expressed concern about the environmental dangers of nuclear energy. One commenter urged the NRC not to reduce EP regulations and stated that the nuclear industry is disregarding safety of the environment and water supply under the proposed regulation. Several commenters expressed concern that the proposed rule does not adequately consider climate change. Three commenters stated that a higher frequency of extreme weather events or natural disasters induced by climate change 14

could potentially result in nuclear disasters. One commenter and a form letter campaign stated that EP requirements are more essential than ever for nuclear facilities due to climate change and the natural disasters that could impact them and asserted that it is arbitrary and capricious for the NRC to promulgate an EP rule without taking into account climate change. One commenter echoed these concerns and stated that climate hazards would intersect with the COVID-19 response, and the NRC must consider how a nuclear facility could become understaffed due to a pandemic. (KPW-1, MW-1, JL-2, SL2-3, JW-2, RB-4, FL1-4)

NRC Response: The NRC disagrees with the comments. As explained in the NRC Response to Comment A-2.3, the NRC is not reducing the level of EP for SMRs and ONTs through this rulemaking as compared to current EP requirements for LLWRs. Further, as explained in the NRCs environmental assessment for this rulemaking, the rules provisions either will not affect the physical environment or will not have any noticeable effects. Regarding climate change, NRC regulations require applicants to design and site their facilities to address design basis accidents and external events such as severe weather.

The NRC and licensees have addressed staffing concerns during a pandemic. In 2010, the NRC issued Regulatory Issue Summary 2010-04, Monitoring the Status of Regulated Activities During a Pandemic (ADAMS Accession No. ML100539611), to enhance the NRCs situational awareness of the status of activities under its regulatory authority before and during a pandemic. The NRC has taken many steps to address various challenges associated with the COVID-19 public health emergency, including staffing levels at nuclear power plants, as described on the NRCs public Web site at https://www.nrc.gov/about-nrc/covid-19/index.html.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment A-2.7: Several commenters wrote that the nuclear industry cannot be trusted to regulate itself. One of the commenters said that nuclear companies will choose to make a profit over keeping Americans safe, thus leading to disaster and potential fatalities. The commenter further noted examples in the oil and chemical industry to assert that business executives value profit over the welfare of Americans. One commenter expressed concerns about the nuclear industrys accident record and said that the industry needs to address the failings of its past.

(AO-1, DF-1)

NRC Response: The NRC disagrees with the comments. The nuclear industry does not regulate itself. In 1954, Congress established the Atomic Energy Commission to regulate the civilian use of radioactive materials under the Atomic Energy Act of 1954, as amended (AEA).

In 1974, through the Energy Reorganization Act, Congress abolished the Atomic Energy Commission and established the NRC as an independent agency to regulate civilian use of radioactive materials. All promotional activities were transferred to the Energy Research and Development Administration, which later became the Department of Energy. Notwithstanding the development of the nuclear power industry and changes to that industry over the decades, the NRCs mission to license and regulate the Nations civilian use of radioactive materials to provide reasonable assurance of adequate protection of public health and safety, promote the common defense and security, and protect the environment is unchanged. This rule helps accomplish the agencys mission. The performance-based regimen provides the NRC with enhanced oversight of the competencies important to the protection of public health and safety.

The performance-based framework, inspection and enforcement program, and design-specific review process provide reasonable assurance that protective actions can and will be taken in the event of an emergency.

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Accordingly, the NRC did not change the rule language in response to these comments.

Comment A-2.8: Several commenters expressed general opposition to reducing plume exposure pathway EPZ requirements. One commenter asserted that the NRC should retain the current 10-mile plume exposure pathway EPZ requirements and that the proposed rule is a radical departure from historical nuclear EP. Another commenter asserted that no matter the size or generating capacity of a reactor, extensive and adequate emergency planning is required. (LMY-1, UW2-1)

NRC Response: The NRC agrees, in part, with the comments. The NRC agrees that adequate emergency planning is required for every SMR and ONT. However, not every SMR and ONT needs the same emergency plan. The performance-based approach to EP provided by this rulemaking provides reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency at an SMR or ONT that complies with this final rule, as explained in the NRC Response to Comment A-2.4. Further, the NRC has historically used a graded approach to EP for other applicants and licensees, such as RTRs.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment A-2.9: One commenter expressed concern that the NRC is prioritizing nuclear industry financial interests and subjugating its responsibility of protecting public health and safety. (SF-1)

NRC Response: The NRC disagrees with the comment. The use and regulation of small reactors and other advanced reactor designs and technology have been active topics of discussion between the NRC and a variety of stakeholders for more than 30 years. The NRC developed the framework for the implementation of performance-based EP regulations with input from all stakeholders and is not prioritizing the financial interests of the nuclear industry.

As explained in the NRC Response to Comment A-2.3, the NRC is not reducing EP regulations through this rulemaking. This rule continues to require that the NRC make a finding of reasonable assurance that adequate protective measures can and will be taken in an emergency.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment A-2.10: Two commenters stated that the public is being used as test subjects for the proposed regulation. One commenter stated that the nuclear industry should abide by the existing regulations first and that it cannot be trusted with public safety. (DE-1, VF-1)

NRC Response: The NRC disagrees with the comments. The NRCs mission is to license and regulate the civilian use of radioactive materials to provide reasonable assurance of adequate protection of public health and safety, promote the common defense and security, and protect the environment. This rulemaking is consistent with the agencys mission. As explained in the NRC Response to Comment A-2.3, the NRC is not reducing EP requirements through this rulemaking. The NRC expects that SMRs and ONTs will be designed with advanced safety features to protect the public. Any SMR or ONT complying with the final rule is required to develop, maintain, and, as necessary, implement emergency plans and coordinate with the Federal, Tribal, State and local governments, as applicable. As explained in the NRC Response to Comment A-2.4, this final rule provides reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency at an SMR or ONT that complies with this final rule.

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Accordingly, the NRC did not change the rule language in response to these comments.

Comment A-2.11: Two commenters indicated that the proposed rule is not supported with any technical or scientific evidence. One commenter stated that there is no science that recommends expansion of SMRs. The other commenter wrote that the lack of technical evidence used to curtail EP in the proposed rule directly contradicts how the NRC has historically prioritized public safety planning. (AN8-1, UW2-2)

NRC Response: The NRC disagrees with the comments. The proposed rule included a detailed technical basis for the proposed EP requirements. The NRC developed this technical basis using historical experience, knowledge of technological advancements, and new research.

Emergency preparedness continues to be a fundamental part of the NRCs regulatory structure.

Further, as described in the NRC Response to Comment A-2.3, the NRC is not reducing EP through this rulemaking.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment A-2.12: One commenter said that if the nuclear industry can survive only via the elimination of safety regulations, then the industry is not viable. The commenter further stated that regulations should not be eliminated just because they are too expensive or onerous for the industry. Regulations can and should be evaluated and changed over time as the world and technologies change. (RU-2)

NRC Response: The NRC agrees, in part, with the comment. The NRC agrees that regulations should be assessed for updates as technology changes. This is precisely what the NRC has done in this rulemaking. The current EP regulations in 10 CFR 50.47(b) and Appendix E to 10 CFR Part 50 were initially written more than 40 years ago for the currently operating LLWRs. The expectation of new reactor designs compelled the NRC to reevaluate the EP requirements in light of these technological changes. The resultant performance-based requirements do not eliminate safety regulations. They provide the same level of EP for SMRs and ONTs as the current EP preparedness requirements for LLWRs.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment A-2.13: One commenter stated that there is an internal disagreement between the Department of Energy (DOE) Office of Nuclear Energy and some National Nuclear Security Administration (NNSA) staff regarding the national security risks of the proposed rule. The commenter said that the NRC should give the NNSAs initial arguments more weight than those of the DOE Office of Nuclear Energy as DOE is tainted by its promotional mission. (UCS-4)

NRC Response: The NRC disagrees with the comment. As required by the Administrative Procedure Act (APA), the NRC offers all interested persons an opportunity to participate in rulemakings through public comment. The NRC considers all public comments equally.

Accordingly, the NRC did not change the rule language in response to this comment.

Mixed or Other General Comments on the Proposed Rulemaking Comment A-3.1: A comment urged the NRC to do the right thing. (HK-1)

NRC Response: The comment suggests no changes to the proposed rule.

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Accordingly, the NRC did not change the rule language in response to this comment.

Comment A-3.2: One commenter expressed support for aspects of the proposed rule but requested further consideration of offsite response requirements. (IDPH-1)

NRC Response: The NRC agrees, in part, with the comment. The NRC has considered all aspects of offsite emergency response. A risk-informed and consequence-oriented approach to EP considers the potential consequences from a spectrum of accidents, including those that can result in an offsite radiological release. The result is a graded approach to EP based on site-specific analyses.

Accordingly, the NRC did not change the rule language in response to this comment.

B. New Performance-Based Emergency Preparedness Framework 10 CFR 50.160(b)(1)

General Comments on New Performance-Based Emergency Preparedness Framework Comment B-1.1: Several commenters expressed general support for the performance-based EP framework. Three commenters wrote that the framework is a positive step toward developing performance-based, technology-inclusive, risk-informed, and consequence-oriented regulations. Two commenters wrote that current regulations targeted at LLWRs are outdated, and it is only appropriate to develop a performance-based framework for new technologies.

Two commenters wrote that the proposed EP framework will allow for increased innovation in the nuclear industry. Finally, two commenters wrote that the proposed EP framework would ensure that the NRC evaluates EP on a case-by-case basis, while another commenter praised the approach of the proposed rule in establishing site-specific emergency plans that would allow facilities to allocate resources to any high-consequence areas. (CI-2, CI-3, CI-5, CI-6, SB-1, NIA-5, HF-10, CRCPD-7, RB-2, RB-3)

NRC Response: The NRC agrees, in part, with the comments. The NRC agrees that the proposed rule would offer a performance-based, technology-inclusive, risk-informed, and consequence-oriented EP framework. However, the NRC disagrees with the comment that current EP regulations are outdated. The existing EP regulatory framework is an effective approach that provides reasonable assurance that protective measures can and will be taken in the unlikely event of an accidental radiological release.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment B-1.2: Several commenters opposed the proposed performance-based EP framework. One commenter wrote that the NRC was abandoning defense-in-depth principles for EP in favor of passive or inherent safety. Similarly, one commenter wrote that defense-in-depth approaches, including specified emergency planning zones, established joint planning standards and evaluation criteria, are critical to EP. One commenter wrote that performance-based regulations are inappropriate for unproven technologies. Similarly, one commenter wrote that previous EP regulations assumed technology was failsafe but incidents such as Three Mile Island proved this is not true. The commenter wrote that infallibly engineered safety is a myth. One commenter wrote that the proposed rule assumes current EP regulations emphasize processes and procedures over performance, but performance is always a key component to assuring readiness and competence. The commenter added that a performance-based framework that does not require plans and procedures would be deficient, 18

and reasonable assurance should not be solely based on drills, exercises, and performance objectives. One commenter expressed concern that the proposed rule does not define the required frequency of drills and exercises, and as a result, SMRs and non-LWR licensees would not be required to conduct a full offsite EP drill every 2 years. Finally, one commenter suggested terms such as performance-based, technology-inclusive, risk-informed, and consequence-oriented are vague, undefined, and intended to confuse the public. (BN-3, FEMA-6, DGY-1, KR-4, NJDEP-7, UW2-13, UWJB-9)

NRC Response: The NRC agrees, in part, with the comments. The NRC is not abandoning defense-in-depth. The Commissions Safety Goal Policy Statement (51 FR 30028, 30033; August 21, 1986) includes the following:

A defense-in-depth approach has been mandated in order to prevent accidents from happening and to mitigate their consequences. Siting in less populated areas is emphasized. Furthermore, emergency response capabilities are mandated to provide additional defense-in-depth protection to the surrounding population [emphasis added].

The level and extent of required EP in this rule is based on a graded approach to EP, commensurate with the relative radiological risk, source term, and potential hazards, among other considerations. This approach is consistent with the NRCs approach to EP for other licensees, such as RTRs.

The NRC disagrees that performance-based regulations are inappropriate for unproven technologies. As explained in the NRC Response to Comment A-2.2, under 10 CFR 50.43(e),

the NRC requires the demonstration of the performance of safety features of new reactor designs before approving the designs.

The NRC agrees with the comment that a performance-based approach that does not include plans and procedures would be deficient, and reasonable assurance should not be solely based on drills, exercises, and performance objectives. The NRC Response to Comment A-2.4 describes how the performance-based approach to EP provided by this final rule affords reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency at an SMR or ONT that complies with this final rule.

The NRC disagrees with the comment that terms such as performance-based, technology-inclusive, risk-informed, and consequence-oriented are vague, undefined, and intended to confuse the public. NUREG-2122, Glossary of Risk-Related Terms in Support of Risk-Informed Decisionmaking, issued November 2013 (ADAMS Accession No. ML13311A353), defines performance-based as focusing on measurable outcomes, rather than prescriptive processes, techniques, or procedures, and risk-informed as a characteristic of decisionmaking in which risk results or insights are used together with other factors to support a decision. However, in the final rules SOC, the NRC clarified technology-inclusive in this rule to mean the principle of establishing performance requirements, for any SMR or ONT applicant or licensee to use in its emergency plan, developed using methods of evaluation that are flexible and practicable for application to a variety of reactor technologies. The NRC also clarified the meaning of consequence-oriented as the principle of basing decisions on the scope of EP required on the potential consequences from a spectrum of accidents, including those that could result in an offsite radiological release.

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The NRC agrees that the proposed rule does not define a required frequency for drills and exercises and that SMR and ONT licensees would not be required to conduct a full offsite EP drill every 2 years. However, the exercise cycle frequency adopted by applicants and licensees should afford sufficient time during which ERO members will be provided ample opportunities to demonstrate their emergency response function capabilities listed in 10 CFR 50.160(b)(1)(iii)(A)-(H). Licensees are also required to maintain these capabilities, and maintenance of the capabilities will be demonstrated through drills and exercises. The NRC stated the following in the proposed rules SOC (85 FR 28436, 28466; May 12, 2020):

[The NRC] anticipates that applicants and licensees would adopt an exercise cycle of eight years during which licensees would vary the content of exercise scenarios to provide [emergency response organization (ERO)] members the opportunity to demonstrate proficiency in the key skills necessary to respond to several specific scenario elements. Applicants and licensees would be required to describe exercise scenario elements necessary to demonstrate the emergency response functions in their emergency plans.

In DG-1350, the NRC stated the following:

The staff will evaluate applications using a graded approach based on site-specific consequence analyses. Program elements that may be implemented and evaluated according to a graded approach include periodicity between inspections, drills, exercises, number of performance objectives, and staffing.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment B-1.3: One commenter wrote that current EP requirements are inadequate, and further reducing requirements would be a relinquishment of regulatory responsibility. The commenter added that the SMRs can still have significant consequences, and nearby communities deserve adequate protection. (SL2-4, SL2-5)

NRC Response: The NRC agrees, in part, with the comments. The NRC agrees that communities around nuclear power plants must have adequate protection. The AEA requires the NRC to provide this level of protection through its regulation of commercial nuclear power plants. However, the NRC disagrees that the proposed rule would reduce EP requirements. In the 1980 Emergency Planning Final Rule (45 FR 55402, 55413; August 19, 1980), the NRC stated that the size of the plume exposure pathway EPZ could be determined on a case-by-case basis for gas-cooled nuclear reactors and for reactors with an authorized power level less than 250 megawatts thermal (MW(t)). The NRC explained that this requirement was based on the lower potential hazard from these facilities (i.e., lower radionuclide inventory and longer times to release significant amounts of activity in many scenarios) (45 FR 55402, 55406). Since 1980, the NRC has used a similar graded approach to EP commensurate with the relative radiological risk, source term, and potential hazards, among other considerations, as demonstrated in the existing regulations in 10 CFR 50.47(b), 10 CFR 50.47(c)(2),

10 CFR 70.22(i), and 10 CFR 72.32, Emergency plan. The SMR and ONT final rule continues this approach.

Accordingly, the NRC did not change the rule language in response to these comments.

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Comment B-1.4: One commenter wrote that the proposed EP framework should include a continuous improvement mechanism that would ensure that licensees revise EP planning as new information and techniques become available. The commenter offered the Fukushima accident as an example, in which the facility was originally built to withstand a 10-to-12-meter tsunami, when later research suggested a more severe incident at the site was possible. The commenter cited techniques such as chaos engineering and testing, improved automation, and required retrospective sessions as options to include, and suggested that facilities include budgets for updated analyses and incorporation of the latest research related to EP. (RB-6, RB-7, RB-8)

NRC Response: The NRC agrees, in part, with the comments. The final rule requires, in 10 CFR 50.54(q), that licensees complying with 10 CFR 50.160 maintain the effectiveness of their emergency plans. This requirement, together with the performance-based approach of 10 CFR 50.160, allows licensees to change their plans as technologies and EP change if the plans continue to maintain their effectiveness and meet the requirements of 10 CFR 50.160.

However, the NRC does not require nuclear power plant licensees to continually assess the possibilities for improvements in EP. Under the NRCs regulatory authority, if new information were to indicate the need for improvements, then the NRC can impose requirements that are necessary to provide reasonable assurance of adequate protection. Further, the NRC could impose enhancements beyond what is necessary for adequate protection, if there is a substantial safety benefit that is cost-justified.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment B-1.5: Two commenters wrote that the requirement for applicants to conduct an initial exercise to demonstrate effectiveness of the EP program no later than 18 months before the issuance of an operating license (OL) is unreasonable. One commenter wrote that current experience with the Vogtle Electric Generating Plant, Unit 3, facility suggests the timeframe is unworkable. The commenter added that there is no radiological risk until fuel load, and the timeline should be closer to authorization for fuel load. The other commenter wrote that it is difficult to see how applicants will have established, implemented, and maintained the emergency planning requirements plus the staffing needed 18 months before issuance of an OL as it may not be logistically or financially feasible. (DBY-2, HF-9)

NRC Response: The NRC agrees, in part, with the comments. The NRC agrees that the proposed rules no later than 18 months before the issuance of an OL for a 10 CFR Part 50 applicant or the scheduled date for initial loading of fuel for a 10 CFR Part 52 combined license (COL) holder is not the appropriate timeframe. The 1980 EP Final Rule required an applicant to hold a full-participation emergency planning exercise within 1 year before receiving the OL of a power plant. That 1-year deadline was based on a scheduling decision to balance the desirability for a timely assessment of the adequacy of the emergency plan and the countervailing need to avoid the scheduling and resource burdens created by the opportunity in an OL proceeding for a hearing on the results of a full-participation exercise. This requirement created some difficulty in scheduling the exercise so that it would allow time for a hearing while still being conducted within 1 year of plant readiness to be licensed.

The Commission changed this requirement in 1987 to require a full-participation emergency planning exercise within 2 years before licensing a power plant (Production and Utilization Facilities; Timing Requirements for Full Participation Emergency Preparedness Exercises for Power Reactors Prior to Receipt of an Operating License; Final Rule (52 FR 16823, 16829; May 6, 1987)). The Commission determined that, based on applicants experience 21

implementing the 1-year requirement and a 2-year post-licensing exercise frequency requirement, 2 years provided an appropriate balance.

In the final rule, the NRC changed the no later than 18 months before requirement to within 2 years before to be consistent with the current requirement in Appendix E to 10 CFR Part 50 for LLWRs and provide flexibility to 10 CFR Part 50 OL applicants and 10 CFR Part 52 COL holders.

Accordingly, the NRC revised the rule language in 10 CFR 50.160(c)(1) and 10 CFR 50.160(c)(2) to allow licensees greater flexibility in demonstrating regulatory compliance.

Comment B-1.6: One commenter wrote that the rule should stipulate the involvement of Tribes in EP drills and exercises, stating that these activities would be vastly strengthened with the inclusion of Tribal EMPs [emergency management programs] who have an interest and responsibility for activities within or near EPZs and IPZs [ingestion exposure pathway emergency planning zones]. The commenter stated that Tribes have limited capacity and capabilities, and the NRC should require provisions in the rule that make Federal resources available to Tribes to assist with sampling, assessing, and implementing precautionary actions prior to incidents and before exceeding dose thresholds. Similarly, the commenter wrote that Tribes have limited capacity to assess and implement quarantine and embargo actions, and proactive integration of Tribes to emergency response functions would bolster Tribal response and mitigation strategies. The commenter also suggested changing dissemination of public information requirements in the rule from the public alert and notification system to the public and Tribal alert and notification systems arguing offsite response organizations (OROs) must include coordination with Tribes. (SBT-3, SBT-4, SBT-12, SBT-13, SBT-21)

NRC Response: The NRC agrees, in part, with the comments. The NRC agrees that activities such as drills and trainings are strengthened with the inclusion of Tribal emergency management programs that have an interest in and identified responsibility in the emergency plan. In the final rule, 10 CFR 50.160(b)(1)(iv)(B)(9) requires an emergency plan to describe the drill and exercise program that tests and implements major portions of planning, preparations, and the coordinated response by the onsite response organizations with the ORO within the plume exposure pathway EPZ. If a Tribe is located within the plume exposure pathway EPZ and is part of the planned offsite response to an emergency at the facility, then the applicant or licensee must include that Tribe in its emergency plans description of its drill and exercise program.

Ingestion pathway response activities are implemented in the intermediate and late phases of response to an accident involving the release of radioactive material. Support for intermediate and late phases of radiological emergency response activities is described in the Nuclear/Radiological Incident Annex (NRIA). The NRIA is part of the National Response Framework (NRF) and describes the policies, situations, concepts of operations, and responsibilities of key Federal radiological resources and assets governing the short-term, immediate, and late phases of response activities for incidents involving the release of radioactive materials. It applies when the nature and scope of the incident require a Federal response to supplement the State, Tribal, or local incident response. The Federal Radiological Monitoring and Assessment Center (FRMAC) is one of the key Federal agencies and is responsible for coordinating environmental radiological monitoring, sampling, and assessment response activities. The FRMAC is available to State, Tribal, and local authorities upon request to respond to nuclear or radiological incidents.

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If a Tribe seeks Federal help with EP, such as assistance and coordination with sampling, assessing, and implementing precautionary actions before accidents, then it should contact FEMA. FEMA provides Federal assistance, services, and access to Federal funds to States, territories, and Tribes to train staff and purchase equipment for offsite EP. FEMA provides training on EP on all hazards, including radiological EP, to interested States and Tribes.

Additionally, FEMA provides hands-on expertise to assist with comprehensive all-hazard plan development, training, and exercises. For more information, refer to FEMAs Tribal Policy found at https://www.fema.gov/about/organization/tribes and to FEMAs National Preparedness Web site, https://www.fema.gov/emergency-managers/national-preparedness.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment B-1.7: One commenter suggested improving the emergency plan change process with a performance-based change process. The commenter noted that the proposed rule uses the emergency change plan process under 10 CFR 50.54(q) which is difficult despite recent attempts to improve it. The commenter suggested that any non-administrative change be demonstrated in a drill or exercise as opposed to a paper analysis as required by the process under 10 CFR 50.54(q). Additionally, the commenter stated that the proposed EP framework is not actually performance-based, as the emergency plan must be submitted for review and approval, similar to current requirements. The commenter suggested an approach in which emergency planning is developed, reviewed, questions asked for clarification and then approved when it is demonstrated in an inspected exercise. (RSX-1, RSX-2)

NRC Response: The NRC disagrees with the comments. The suggested approach for approving an emergency plan is not significantly different from the current licensing approach.

An emergency plan is part of the required content of applications under 10 CFR Part 50 and 10 CFR Part 52. The NRC reviews the emergency plan and may ask questions for clarification.

The licensee demonstrates implementation of the emergency plan as part of the required EP inspections, tests, analyses, and acceptance criteria in an inspected exercise for a 10 CFR Part 52 COL holder or in an evaluated exercise within 2 years before the NRC issues a full power Part 50 OL.

As stated in 10 CFR 50.54(q), licensees may make emergency plan changes without NRC approval only if the licensee performs and retains an analysis that the changes do not reduce the effectiveness of the plan. Additionally, 10 CFR 50.54(q) does not prescribe how the licensee performs the analysis. Such analyses could be performed in a variety of ways, such as through research, pilot programs, or during a drill or exercise. Evaluation of the successful demonstration of the changes to the emergency plan would be documented in the analysis.

The NRC cannot rely solely on a demonstration of the plan change, as suggested by the comments. Demonstration of a plan change in an evaluated drill or exercise would show the plans adequacy only under the specific drill or exercise conditions and not the rest of the spectrum of accidents for which the licensee is required to respond. Analysis in addition to the demonstration would be required.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment B-1.8: One commenter asked if an existing LLWR could use the license amendment request process under proposed 10 CFR 50.54(q)(7) to transition to the plume exposure 23

pathway EPZ and IPZ requirements under 10 CFR 50.160 if they can prove the risk for the LLWR is the same as for an SMR with a 10-mile plume exposure pathway EPZ. (BM-14)

NRC Response: An existing LLWR could not use the license amendment request process under 10 CFR 50.54(q)(7) to transition to the EP requirements under 10 CFR 50.160. In the final rule, 10 CFR 50.54(q)(7) is applicable only to SMRs, non-LWRs, and NPUFs licensed after the effective date of the final rule. LLWRs were not included in the scope of this rule, not because of the potential radiological consequence posed by an LLWR, but because an EP licensing framework already exists for LLWRs, and current LLWR licensees have not expressed an interest in changing the current framework. Comments concerning a performance-based, consequence-oriented approach to EP for entities besides SMRs and ONTs are addressed in the NRC responses to comments in Section H.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment B-1.9: One commenter recommended that the NRC should remove as applicable from the proposed rule in 10 CFR 52.17(b)(2)(i) and (ii) and 10 CFR 52.18, Standards for review of applications, as it is an undefined term, inconsistent with comparable FEMA consultation language in those sections, and inconsistent with the memorandum of understanding between FEMA and the NRC, dated December 7, 2015 (ADAMS Accession No. ML15344A371). The commenter also suggested changing that there is not significant impediment to that there is not a significant impediment in 10 CFR 52.18. (BM-21)

NRC Response: The NRC agrees, in part, with the comment. The NRC proposed using the words as applicable in 10 CFR 52.17(b)(2)(i) and (ii) and 10 CFR 52.18 regarding the NRCs consultation with FEMA because, under 10 CFR 50.160, the NRCs consultation with FEMA would not always be necessary. For some applicants and licensees, the rule would allow for a site boundary plume exposure pathway EPZ, which would not require a formal offsite radiological EP program. In that case, NRC consultation with FEMA would not be required.

Accordingly, the NRC did not change the rule language in response to this part of the comment.

However, the NRC agrees that the word a was missing from proposed 10 CFR 52.18 and revised the text to read, there is not a significant impediment in the final rule.

Comment B-1.10: One commenter noted that the proposed rule requires applicants to describe the data link that will provide information to the NRC, but does not provide any guidance on safety parameters, type of information that should be provided, or timeframe for activation of the Emergency Response Data System following an event. (DBY-3)

NRC Response: The NRC disagrees with the comment. As described in the proposed rule SOC (85 FR 28436, 28450), applicants and licensees choosing to follow 10 CFR 50.160 will be required to describe in their emergency plans the data links with the NRC for use in emergencies. Specific parameters to be reported will be determined for the specific technology during the license application process under 10 CFR Part 50 or 10 CFR Part 52. The NRC will review each applicants data transmission capabilities on a case-specific basis.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment B-1.11: One commenter asked if the proposed rule should define safe condition, including it in 10 CFR 50.2, Definitions. (DBY-4) 24

NRC Response: In the proposed rule SOC (85 FR 28436, 28447), the NRC defined safe conditions to mean the facility has been restored to a radiologically safe and stable condition.

The NRC kept the definition in the final rule SOC and added it to DG-1350.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment B-1.12: One commenter recommended that emergency plans should avoid calling on local elected officials to be the principal decisionmaker regarding sheltering and evacuation as this may lead to over-evacuation. In addition, the commenter noted that local elected officials frequently change. (MU-13)

NRC Response: The NRC disagrees with the comment. Nuclear power plant licensees are required to have in place emergency plans that specify the OROs responsible for coping with emergencies. State, local, and Tribal officials designate OROs and decisionmakers. Nuclear power plant licensees recommend protective actions to the OROs and decisionmakers. Only State, local, and Tribal officials have the authority to make decisions concerning public health and safety for their jurisdictions. The NRC does not have the authority to determine who makes these decisions.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment B-1.13: One commenter stated that performance objectives under 10 CFR 50.160(b)(1)(iii) may become confused with existing EP Reactor Oversight Process (ROP) indicators. The commenter suggested clarifying in the proposed rule and guidance that the requirements in 10 CFR 50.160(b)(1)(iii) are not part of the ROP, but instead are maintained for review as part of routine inspections. (NEIA-27)

NRC Response: The NRC agrees, in part, with the comment. The performance objectives under 10 CFR 50.160(b)(1)(iii) could be confused with EP ROP performance indicators.

However, the NRC currently does not know what the ROP will be for SMRs and ONTs. This means that, at this time, the NRC does not know what the relationship will be between 10 CFR 50.160 and the ROP.

Accordingly, the NRC revised the SOC to state that the agency will monitor the licensees performance objectives and metrics, without referencing the ROP.

NRC Question: Would an 8-year exercise cycle (as is currently required for LLWRs) be appropriate for SMRs or ONTs choosing to comply with the performance-based approach? If not, would an alternative cycle length be appropriate?

Comment B-2.1: Several commenters noted that the current 8-year exercise cycle is effective, with some commenters stating that it would provide the same level of reasonable assurance.

(NJDEP-18, NEIA-8, CRCPD-17, CRCPD-18, IDPH-9)

NRC Response: The NRC agrees, in part, with the comments. The 8-year requirement in Appendix E to 10 CFR Part 50 for LLWRs has proven to be appropriate and effective for those reactors. However, the NRC is not requiring licensees to adopt an 8-year cycle or any exercise frequency. As a performance-based approach to EP, the rule provides performance objectives without prescribing deterministic methods to meet those objectives. Drills and exercises are one example of this approach. Licensees must have performance objectives under 10 CFR 50.160(b)(1)(ii). Performance objectives measure emergency response performance 25

(i.e., compliance with requirements). Those requirements include, at a minimum, the capability to demonstrate the emergency response functions listed in 10 CFR 50.160(b)(1)(iii)(A)-(H).

Licensees demonstrate those capabilities through drills and exercises required under 10 CFR 50.160(b)(1). So, even without required exercise cycles or frequencies, licensees will have to perform drills and exercises to meet these requirements. The NRC will monitor the performance objectives and metrics to ensure that licensees maintain adequate emergency planning and preparedness.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment B-2.2: One commenter suggested that the length of the exercise cycle should be reduced given that design elements associated with SMRs and ONTs are still being refined.

(SBT-20)

NRC Response: The NRC agrees, in part, with the comment. The length of the exercise cycle in 10 CFR 50.160 could be less than the 8-year requirement in Appendix E to 10 CFR Part 50 for LLWRs. However, the NRC is not requiring licensees to adopt any exercise frequency. As a performance-based approach to EP, the rule provides performance objectives without prescribing deterministic methods to meet those objectives. As explained in the NRC Response to Comment B-2.1, drills and exercises are one example of this approach. The NRC will monitor the performance objectives and metrics to ensure that licensees maintain adequate emergency planning and preparedness.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment B-2.3: One commenter expressed support for conducting an offsite EP drill every 2 years with completion of the full suite of EP exercises over an 8-year cycle. The commenter asserted that the drill and exercise cycle should compensate for the turnover of key personnel at the facility and with State, Tribal, and local authorities. The commenter also noted that as SMR and ONT operational history is established, lessons learned may be incorporated. The commenter also wrote that drills and exercises should include interfacing between onsite staff and offsite authorities. (UCSJT-8)

NRC Response: The NRC agrees, in part, with the comment. The NRC agrees that licensees using the performance-based EP approach in 10 CFR 50.160 will need to demonstrate through drills and exercises capabilities such as communications with OROs and making protective action recommendations to OROs as conditions warrant. These requirements are found under 10 CFR 50.160(b)(1)(iii). However, the NRC disagrees that it needs to require an offsite drill every 2 years and a full exercise cycle every 8 years. As a performance-based approach to EP, the rule provides performance objectives without prescribing deterministic methods to meet those objectives. As explained in the NRC Response to Comment B-2.1, drills and exercises are one example of this approach. The NRC will monitor the performance objectives and metrics to ensure that licensees maintain adequate emergency planning and preparedness.

The NRC disagrees with the comment stating that the drill and exercise cycle should compensate for the turnover of key personnel at the facility and with State, Tribal and local authorities. In 10 CFR 50.160(b)(1)(iii)(E), the NRC requires applicants and licensees to establish staffing for the facility necessary to implement the roles and responsibilities in 10 CFR 50.160(b)(1)(iii). Regulatory Guide (RG) 1.242 states in part that the emergency plan should describe the process used to train, before assigning roles and responsibilities, as well as retrain, the emergency response team members.

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Accordingly, the NRC did not change the rule language in response to this comment.

NRC Question: The NRC is therefore considering aligning the discussion of the EP framework in this rule with its other risk-informed, performance-based regulations and considering eliminating the use of the descriptors dose-based and consequence-oriented, but intends no change to the meaning of the proposed regulations. Would such a change impact the clarity and predictability of the regulations?

Comment B-3.1: Several commenters supported the use of risk-informed regulations, and two commenters supported the elimination of the descriptors dose-based and consequence-oriented. Several commenters added that the risk-informed framework is not as clear as the regulations under 10 CFR 50.47(b), which could lead to inconsistencies in implementation. One commenter said that use of the term risk-informed would more clearly allow for consideration of the public, environmental, and economic risks of an offsite radiological release. One commenter wrote that alignment would not impact the clarity and predictability of the proposed regulations if the final rule acknowledges the alignment and makes clear that terms have been subsumed by new terminology. Finally, one commenter wrote that risks should be inclusive of stakeholder interests and not limited to certain dose values or measures.

(NJDEP-11, NEIA-1, CRCPD-10, IDPH-5)

NRC Response: The NRC agrees, in part, with the comments. Risk-informed regulation is an approach to regulatory decisionmaking that considers a combination of risk insights such as engineering analysis, defense-in-depth, safety margins, and performance history to establish requirements. A performance-based regulatory framework focuses on measurable outcomes, specifies requirements to be met, and provides flexibility to an applicant or licensee regarding the information or approach needed to satisfy those requirements. A risk-informed, performance-based EP framework, by design, will be less defined than the current EP regulations in 10 CFR 50.47(b) and Appendix E to 10 CFR Part 50. How a licensee implements the risk-informed, performance-based EP requirements will depend on the design of the licensees facility, so one licensee may implement the requirements differently than another licensee. That is not inconsistent implementation or regulation because every licensee will be required to satisfy the same requirements. Different does not mean inconsistent.

The NRC did not remove dose-based and consequence-oriented from the rule because those terms are appropriate and beneficial descriptors that define the risk insights used to develop the final rule. These risk insights include the risks of an offsite radiological release because a risk-informed and consequence-oriented approach considers the potential consequences from a spectrum of accidents, including those that could result in an offsite radiological release. The result is a graded approach to EP based on site-specific analyses.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment B-3.2: One commenter wrote that it would be misleading to remove dose-based from the regulations as the proposed rule would still fundamentally base EP requirements on dose. (UCS-17)

NRC Response: The NRC agrees, in part, with the comment. The NRC did not remove the term dose-based from the SOC for the final rule. The term is used in the SOC to describe, in part, the EP framework suggested in SECY-11-0152, Development of an Emergency Planning 27

and Preparedness Framework for Small Modular Reactors, dated October 28, 2011 (ADAMS Accession No. ML112570439). As stated in the NRC Response to Comment B-3.1, dose-based describes one of the specific risk insights used to develop the final rule. However, the NRC disagrees that the final rule is fundamentally based on dose. The level and extent of required EP in this rule are based on a graded approach to EP, commensurate with the relative radiological risk, source term, and potential hazards, among other considerations. This approach is consistent with the NRCs approach to EP for other licensees, such as RTRs.

Accordingly, the NRC did not change the rule language in response to this comment.

Offsite and Onsite Emergency Preparedness Planning Comment B-4.1: Several commenters criticized the proposed rules offsite emergency planning requirements and the impact they would have on public health and safety. One commenter wrote that without appropriate offsite planning, there will be no mechanism for radiological assessment and formulation of protective action recommendations. As a result, decisionmakers will not be able to evaluate offsite radiological consequences and make decisions to reduce public exposure to radiation. One commenter stated that SMR facilities would be sited close to residential areas, and as a result, it would be unwise to allow for reduced offsite planning requirements. The commenter also recommended that the NRC should prioritize public health and safety instead of relief from the regulatory burden and increased regulatory stability and predictability. The commenter wrote that, instead, regulatory stability and predictability are maintained by ensuring that communities have offsite emergency planning. One commenter wrote that some basic offsite planning should occur regardless of plume exposure pathway EPZ size, and the rule should include additional requirements related to ingestion planning. One commenter wrote that SMRs may have higher electricity production costs per unit than LLWRs, and this drives cost cutting, which may come at the expense of safety. The commenter wrote that, as a result, the NRC should not shrink and eliminate offsite emergency planning, especially considering that multiunit SMR facilities could have the same combined radiological source term as other larger reactors. Finally, one commenter wrote that because of the unique nature of nuclear power, public health and safety concerns warrant more robust offsite EP requirements than the proposed rule provides. (BF-1, GM-1, BN-2, FEMA-1, NJDEP-4, IDPH-10, UW2-24, UW2-25, UW2-30, UW2-61, UW2-62, UW2-63)

NRC Response: The NRC disagrees with the comments. The NRC is not eliminating offsite EP with this rulemaking. State and local comprehensive all-hazards emergency response plans are tested by real events almost daily across the United States. The hazards that prompt the implementation of these response actions are sometimes immediately dangerous to life and health. These responses are frequently ad hoc responses and save lives. As described in the NRC Response to Comment B-7.2, communities can still develop and maintain radiological response capabilities without an NRC requirement for an offsite plume exposure pathway EPZ.

This rulemaking allows for a site boundary plume exposure pathway EPZ, but the applicant or licensee must justify such a plume exposure pathway EPZ. This rulemaking does not guarantee that a licensee will have a site boundary plume exposure pathway EPZ. Licensees and applicants that successfully justify a site boundary plume exposure pathway EPZ would not include a General Emergency declaration in their emergency plans. Therefore, no prompt protective offsite radiological response measures or training would be required by the NRC for Tribal, State, and local government organizations.

Accordingly, the NRC did not change the rule language in response to these comments.

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Comment B-4.2: One commenter wrote that the rule should ensure that Tribes are consulted on a government-to-government basis and fully integrated into EP requirements. The commenter wrote that the rule could potentially exclude Tribes that fall outside plume exposure pathway EPZs but have cultural, historic, or administrative ties to the area of potential effect.

The commenter requested that the NRC address this by requiring consultation and coordination with Tribal governments throughout the development of emergency planning and integrating the NRCs Tribal Protocol Manual into requirements. The commenter offered an example of the IPZ requirements in the rule, stating that the approach requires government-to-government consultation with Tribal authorities. The commenter also wrote that any provision of the rule stipulating involvement of Tribal authorities must be negotiated with the Tribe directly and not through a non-governmental applicant. The commenter recommended that the NRC include provisions in the rule for the inclusion of Tribal government health and safety responsibilities that fall outside of State jurisdictions to clarify lines of authority and responsibility. The commenter also suggested that the NRC modify the event classification and mitigation portion of the proposed rule, arguing that applicants and licensees will be able to establish their own emergency classification scheme for determining whether to notify Tribes. Additionally, the commenter wrote that any modifications to plume exposure pathway EPZ sizes, including expansion beyond the administrative site boundary, must be shared with Tribes in face-to-face consultations on a government-to-government basis. (SBT-1, SBT-2, SBT-11, SBT-15, SBT-17, SBT-18, SBT-25, SBT-26, SBT-27, SBT-28)

NRC Response: The NRC agrees, in part, with the comments. Regarding government-to-government consultation, the NRC consults in good faith with Tribes on agency actions that have substantial direct effects on Tribes, as well as those regulatory actions for which Tribal consultation is required under Federal statute. Under the NRCs Tribal Policy Statement (82 FR 2404, 2416; January 9, 2017), The NRC will provide timely notice and consult in good faith with Tribal governments on NRCs regulatory actions that have substantial direct effects on one or more Indian Tribes as well as those regulatory actions for which Tribal consultation is required under Federal statute. The NRC also follows NUREG-2173, Revision 1, Tribal Protocol Manual, issued July 2018 (ADAMS Accession No. ML18214A663) on all communication with Tribes.

The NRC disagrees with the commenters assertion that the rule could potentially exclude Tribes that fall outside plume exposure pathway EPZs but have cultural, historic, or administrative ties to the area of potential effect. The NRC will offer consultation to Tribes that have cultural, historic, or administrative ties to the area of potential effect through the licensing proceeding consistent with Federal statutes and the NRCs Tribal Policy Statement.

The NRC disagrees with the commenters suggestion that the NRC serve as a neutral entity for licensee event classification and mitigation communications with Tribes during an emergency.

Because of the potential need to take immediate action offsite in the event of a significant radiological accident, notifications to appropriate OROs must go directly from the facility licensee to affected OROs. Adding the NRC to licensee communications with Tribes would degrade the timeliness of this required capability to promptly declare and classify emergency conditions and notify OROs of recommended protective actions such as evacuation or sheltering. As a result, potential delays in implementing offsite protective actions could negatively affect public health and safety.

The NRC agrees that in licensing actions in which the applicant proposes to comply with 10 CFR 50.160 and which have a substantial direct effect on one or more Tribes, the Tribe(s) need 29

to be consulted in those licensing actions. The NRCs guidance for reviewing applications that would comply with 10 CFR 50.160 will direct the NRC staff to consider, consistent with the Tribal Policy Statement, whether the action may have a substantial direct effect on one or more Tribes. The NRC also revised DG-1350 to include a statement to inform potential applicants that they may need to reach out to States or the NRC or another Federal agency, as applicable, to coordinate with Tribes to obtain information to meet the NRCs application requirements for emergency planning. Part of this coordination could be determining whether, and if so, how, the Tribes would be notified during an emergency under the applicants emergency classification scheme.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment B-4.3: One commenter wrote that the proposed rule does not include mitigation capability demonstration, which is a critical regulatory requirement. Additionally, the commenter said that consideration of integrating safeguards incidents into emergency response seems to be missing and suggested that the rule require demonstration of response capabilities that address hostile action and integrated emergency response. (RSX-3, RSX-8)

NRC Response: The NRC disagrees with the comments. The proposed rule did include a mitigation capability demonstration requirement. Proposed 10 CFR 50.160(b)(1)(iii) describes the emergency response functions that licensee emergency response teams must have the capability to successfully demonstrate in drills or exercises. The first required response function is event classification and mitigation, which is the ability to assess, classify, monitor, and repair facility malfunctions in accordance with the emergency plan to return the facility to safe conditions.

The NRC also disagrees with the comment that integrating safeguards incidents into emergency response is missing. In the proposed rule, 10 CFR 50.160(b)(1)(iv)(A)(2) requires applicants and licensees to be capable of implementing their approved emergency response plan in conjunction with their safeguards contingency plan. As explained in the proposed rule SOC,

[L]icensees should coordinate security-related and emergency response activities to ensure an adequate and efficient response to a radiological event.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment B-4.4: One commenter suggested that core damage assessment should be considered a recovery or planning effort rather than a response capability because regulatory oversight of exercises has shown that core damage assessment is of little value during response. Radiological assessment is sufficient to determine the impact on the facility and public during response. Additionally, the commenter wrote that reentry has little value in ensuring reasonable assurance that the emergency plan can and will be implemented and suggested it be required for mitigation efforts only. (RSX-5, RSX-6)

NRC Response: The NRC agrees, in part, with the comments. The NRC disagrees that core damage assessment as a response capability is of little value during response and that radiological assessment is sufficient to determine the impact on a facility and the public during response. Core damage assessment is a key input to radiological dose assessment and projection. The amount of core damage relates directly to the amount of source term for release: the greater the source term, the greater the magnitude of the release and the greater potential impact to the public. Therefore, the NRC requires licensees to have the capability to assess core damage.

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The NRC agrees that reentry can be a mitigative action. However, the NRC disagrees with the suggestion that reentry be required for mitigation efforts only and that it has little value in ensuring reasonable assurance that the emergency plan can and will be implemented. Reentry can occur as a response action, such as augmenting the on-shift ERO during a hostile-action-based emergency or implementing diverse and flexible mitigation capabilities. To support these efforts, licensees need to demonstrate the required coordination with OROs on offsite reentry points, including the conditions necessary to allow reentry. These conditions include establishing access control points to issue dosimetry and train reentering individuals on its use, developing stay times for restricted areas to prevent exceeding exposure limits, providing escorts trained in the use of dosimetry, and providing monitoring and decontamination for exiting individuals.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment B-4.5: One commenter wrote that past evacuation time estimates (ETEs) for new reactor license applications have included consideration of the evacuation of people within the site boundary, while the proposed rule seems to require consideration only of those outside the site boundary. In addition, the commenter wrote that ETE requirements should include special events that occur within the plume exposure pathway EPZ that warrant special consideration to maintain consistency with NUREG/CR-7002, Revision 1, Criteria for Development of Evacuation Time Estimate Studies, issued February 2021 (ADAMS Accession No. ML21013A504). (BN-19, BM-20)

NRC Response: The NRC agrees with the comments. ETEs are a calculation of the time to evacuate various sectors and distances within the facilitys plume exposure pathway EPZ. This includes the nuclear power plant site location, as described in NUREG/CR-7002, Revision 1.

While the proposed rule language provides for development of an ETE of the areas beyond the site boundary and within the EPZ, the phrase areas beyond the site boundary could be interpreted to exclude the area within the site boundary. For this reason, the NRC revised the rule language by removing the phrase, beyond the site boundary and to clarify that the ETE study area encompasses the entire area within the plume exposure pathway EPZ, including the area within the plant site boundary. In addition, the NRC revised DG-1350, Section C.7(e), to refer to NUREG/CR-7002, Revision 1, which provides guidance for considering special events, such as the construction of new reactors, and other activities within the plume exposure pathway EPZ in the development of an ETE study.

Accordingly, the NRC removed beyond the site boundary and from 10 CFR 50.160(b)(1)(iv)(B)(4).

Comment B-4.6: One commenter wrote that current ETE guidance in NUREG/CR-7002 is based on an evacuation of a 10-mile plume exposure pathway EPZ, and the proposed rule and guidance should be updated to limit the scope of the ETE study in line with site-specific ETE requirements to reduce unnecessary burden. (NEIA-28)

NRC Response: The NRC agrees with the comment. In February 2021, the NRC published NUREG/CR-7002, Revision 1, which contains new guidance for preparing ETEs for scalable plume exposure pathway EPZ sizes. This revised guidance will assist applicants and licensees in developing ETEs that are commensurate with site-specific plume exposure pathway EPZs.

The NRC staff revised DG-1350, Section C.7(e), to refer to NUREG/CR-7002, Revision 1.

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Accordingly, the NRC did not change the rule language in response to this comment.

Comment B-4.7: One commenter suggested improvements to the proposed rule to ensure that EP planning standards are performance-based. The commenter noted that the proposed rule focuses on drills as the primary method to demonstrate maintenance of effective response capabilities and that drills should be one means of achieving compliance with the rules performance-based requirements. The commenter recommended that the NRC adopt language from DG-1350 specifying that the NRC staff will evaluate applications using a graded approach based on site-specific consequences including periodicity between inspections, drills, exercises, number of performance objectives, and staffing. The commenter wrote that this would allow the performance-based framework to adapt to new technologies and new methods for demonstrating response capabilities. (NEIA-7)

NRC Response: The NRC agrees, in part, with the comment. The proposed rule SOC included language that described how the NRC will evaluate applications using a graded approach to EP based on site-specific characteristics and consequences. The NRC disagrees that the proposed rules performance-based regulatory approach does not have clear measurable outcomes. The desired measurable outcomes for this rule are the successful demonstration of the emergency response functions listed in 10 CFR 50.160(b)(1)(iii) during drills or exercises. In addition, the proposed set of required planning activities in 10 CFR 50.160(b)(1)(iv) accounts for those EP-related activities not readily observable or effectively measured through drills and exercises. The NRC will determine licensee compliance with these requirements through the NRCs inspection program.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment B-4.8: One commenter wrote that 10 CFR 50.33(g)(2)(i)(A) in the proposed rule requires applicants and licensees to submit emergency plans for governmental entities within the plume exposure pathway EPZ, which seems to be arbitrary and insufficient. The commenter wrote that FEMA and other Federal entities with an interest in the plume exposure pathway EPZ, such as land administered by other Federal agencies (including the Bureau of Land Management, Forest Service, and National Parks Service), navigable waterways, and Federal highways, should be included in these requirements. (UW2-55, UW2-56)

NRC Response: The NRC disagrees with the comments. The Federal Governments responses to various emergencies, including radiological emergencies, are described in the NRF, one of the five National Planning Frameworks constituting the National Preparedness System required by Presidential Policy Directive 8, National Preparedness, dated March 30, 2011. The Federal Interagency Operational Plans (FIOPs) describe how the Federal Government aligns resources and delivers core capabilities to implement the National Planning Frameworks. Incident annexes to the FIOPs, such as the NRIA to the Response and Recovery FIOP, address concepts of operations, roles, responsibilities, critical tasks, or resources for a unique threat or hazard that requires additional information not addressed by the FIOPs. The NRIA describes the policies, situations, concepts of operations, and responsibilities of key Federal radiological resources and assets governing the early, immediate, and late phases of response for incidents involving a release of radioactive materials. It applies to incidents of a nature and scope that require a Federal response to supplement the State, Tribal, or local incident response. FEMAs Web site, at https://www.fema.gov/emergency-managers/national-preparedness, contains more information on these topics.

Accordingly, the NRC did not change the rule language in response to these comments.

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Comment B-4.9: One commenter provided general support for the proposed rules requirements, writing that it would reflect safety enhancements and current methodologies for plume exposure pathway EPZ size, onsite and offsite emergency planning, and the number of emergency response staff needed. (DOE1-6)

NRC Response: The NRC agrees with the comment. The rulemaking appropriately reflects safety enhancements and current methodologies for plume exposure pathway EPZ size and onsite and offsite emergency planning, including emergency response staffing.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment B-4.10: One commenter suggested that the proposed rule should treat public information capabilities as a component of the response rather than a planning requirement.

(RSX-4)

NRC Response: The NRC disagrees with the comment. Although 10 CFR 50.160(b)(1)(iv) is titled, Planning activities, the public information capabilities required in that section are also components of the licensees response. Having the capability to prepare and issue public information during emergencies is part of the licensees planning for emergencies, and issuing that information during an emergency is part of the licensees response. Under 10 CFR 50.160(b)(1)(iv)(A)(1), licensees must maintain the capability to prepare and issue public information during emergencies. The issuance of public information during emergencies involves, for example, developing press releases and addressing the media, including social media. Under 10 CFR 50.160(b)(1)(iv)(B)(7), which applies when the licensee has a plume exposure pathway EPZ beyond the site boundary, the emergency plan must contain a description of the means by which public information is provided to the members of the public concerning emergency planning information, public alert notification system, and any prompt actions that need to be taken by the public. This provision requires the licensee to distribute to the public information concerning offsite emergency planning information, such as the actions to take if someone hears a siren or evacuation routes. During an emergency, the licensee would need to keep the media and OROs apprised of the emergency by providing initial and updated information.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment B-4.11: One commenter stated that the proposed rule would replace 15 of the 16 planning standards under 10 CFR 50.47(b) and Appendix E to 10 CFR Part 50 with 11 new planning requirements under 10 CFR 50.160(b)(1)(iv)(B) for applicants with a plume exposure pathway EPZ beyond the site boundary. As a result, the commenter asked why an applicant with a 10-mile plume exposure pathway EPZ would be eligible for reduced planning requirements under the proposed rule despite requiring the same 10-mile plume exposure pathway EPZ as those facilities with more extensive planning requirements under current rules.

The commenter requested clarification of the situation, including whether an offsite IPZ would also be required. (BM-12)

NRC Response: The NRC disagrees with the comment. In the proposed rule, the NRC did not attempt to match each regulatory requirement contained in 10 CFR 50.47(b) and Appendix E to 10 CFR Part 50. The current EP planning standards in 10 CFR 50.47(b) were developed for LLWRs, and the requirements in Appendix E to 10 CFR Part 50 were developed for LLWRs and non-power reactors. With its risk-informed, performance-based approach, this final rule 33

recognizes advances in design and technological advancements embedded in design features of SMRs and ONTs; credits safety enhancements in evolutionary and passive systems; and credits the potential benefits of smaller sized reactors and non-LWRs associated with postulated accidents, including slower transient response times and relatively small and slow release of fission products. Although the two sets of EP requirements are different, the level of EP is the same under 10 CFR 50.160 and the current EP requirements.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment B-4.12: One commenter wrote that the proposed rule should allow facilities to scale offsite EP considerations when a facility is sited within a large land area owned by a Federal or State entity, which the public cannot access. (NEIA-15)

NRC Response: The NRC agrees, in part, with the comment. The NRCs case-by-case and design-specific review process plus the performance-based EP framework of 10 CFR 50.160 allow applicants and licensees to propose site-specific methods of meeting the applicable requirements of 10 CFR 50.160. Given the particular facts and circumstances of the application, an applicant or licensee also can request exemptions from requirements. So, the NRC allows applicants and licensees to propose scaled offsite emergency plans and does not need to explicitly address the situation described in the comment.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment B-4.13: One commenter supported the proposed rules approach to drills and exercises, writing that it allows the appropriate flexibility for applicants to determine drill and exercise requirements, with NRC approval, in a performance-based and technology-neutral manner. The commenter noted that not explicitly prescribing drills or exercises in the rule language or RG is consistent with the NRCs performance-based, technology-neutral approach.

(NNSA2-14)

NRC Response: The NRC agrees with the comment. The rules approach to drills and exercises allows applicants and licensees appropriate flexibility to meet the rule requirements in a performance-based and technology-neutral (i.e., technology-inclusive) manner.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment B-4.14: One commenter stated that the proposed rules emergency planning requirements do not consider the possibility of multiple emergency scenarios that could impact an SMR or ONT and the surrounding area. The commenter offered examples of unforeseen events such as a fire, flood, hurricane, explosion, seismic event, terrorist attack, national conflict, or cyber threats. (UW2-45)

NRC Response: The NRC disagrees with the comment. Although not called out specifically, the example emergency scenarios in the comment would be addressed both in existing regulations under 10 CFR 100.20, Factors to be considered when evaluating sites, and in this rule. Under 10 CFR 100.20, nuclear power plant applicants must evaluate various hazards at a site, including human-related hazards (e.g., airports, dams, transportation routes, military and chemical facilities) and physical characteristics of the site, including seismology, meteorology, geology, and hydrology. Terrorist attacks and cybersecurity threats are outside the scope of this rulemaking because they would be addressed by an applicants physical security and cybersecurity plans, respectively.

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Under 10 CFR 50.160(b)(1)(iii)(A), applicants and licensees must be capable of assessing and classifying facility malfunctions that could occur from a range of initiating conditions. As described in RG 1.242, the emergency plan should describe how the licensee will classify the events that would warrant an emergency declaration and the associated emergency action levels (EALs) and immediate actions to provide an appropriate graded response. RG 1.242 provides sample EALs, such as External Hazards or Natural Phenomena, which includes initiating conditions like natural phenomena (e.g., high windspeeds, high/low ultimate heat sink, seismic), technical hazards (e.g., hazardous gases, hostile-action-based event, fire), and hazardous chemical releases incident to the processing of licensed material. Also, 10 CFR 50.160(b)(2) requires applicants and licensees to submit a hazard analysis of contiguous or nearby facilities, such as industrial, military, and transportation facilities, along with any credible hazards that could adversely impact the implementation of emergency plans.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment B-4.15: One commenter expressed support for the proposed revisions to 10 CFR 50.10(a)(1)(vii), which would include onsite emergency facilities necessary to comply with 10 CFR 50.160 requirements within the scope of items for which a construction permit or limited work authorization is necessary to commence construction. (UW2-50)

NRC Response: The comment supports the proposed rule and suggests no changes to the proposed rule.

Accordingly, the NRC did not change the rule language in response to this comment.

NRC Question: Are there additional emergency response functions that the NRC should consider for incorporation in this proposed rulemaking?

Comment B-5.1: Two commenters noted that the proposed rule does not appear to contain adequate performance objectives to implement a true performance-based approach, and as a result, it is difficult to comment on any additional emergency response functions. (NJDEP-17, CRCPD-16)

NRC Response: The NRC disagrees with the comments. The rule contains performance-based provisions that require the applicant or licensee to establish performance objectives based on the applicants or licensees facilitys design. Based on the performance objectives, the applicant or licensee develops performance metrics to measure performance (i.e., determining when or how successful performance is achieved), and the NRC evaluates the metrics to ensure they are acceptable. The NRC or the industry may develop future additional guidance related to performance objectives for specific designs or classes of designs.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment B-5.2: Two commenters indicated that the proposed rule contains the appropriate emergency response functions. One commenter stated that the proposed rule does not require any additional emergency response functions. The other commenter noted that the emergency response functions listed in the proposed rule cover the important components of offsite response coordination. (NEIA-6, IDPH-7a) 35

NRC Response: The NRC agrees with the comments. The emergency response functions in the rule are appropriate for the performance-based approach to EP for SMRs and ONTs.

Accordingly, the NRC did not change the rule language in response to these comments.

NRC Question: Are there any planning activities that should be added to or removed from the NRCs proposed list?

Comment B-6.1: Two commenters stated that the proposed rule has the potential to cause confusion with existing planning standards, and the proposed performance-based approach is not a true performance-based approach but rather a hybrid approach. One commenter wrote that it is unclear what measurable outcomes under 10 CFR 50.160 replace the old deterministic planning standards under 10 CFR 50.47(b). As a result, planning standards may need to be removed or added to make the methodology a strictly performance-based approach.

(NJDEP-19, CRCPD-8, CRCPD-19)

NRC Response: The NRC agrees, in part, with the comments. The NRC agrees that the rule is not entirely performance-based. As explained in the proposed rule SOC, some EP-related activities, called planning activities in the rule, are not readily observable or effectively measured through drills and exercises. Some of these planning activities may not be performance based, but the rule is, on the whole and in comparison to the current EP requirements in 10 CFR 50.47(b) and Appendix E to 10 CFR Part 50 performance-based.

The NRC disagrees that the rule has the potential to cause confusion with the planning standards in 10 CFR 50.47(b). The rule clearly states that applicants and licensees must use either the EP framework of 10 CFR 50.47(b) and Appendix E to 10 CFR Part 50 or the requirements in 10 CFR 50.160.

Accordingly, the NRC did not change the rule language in response to these comments.

Offsite Response Organization Participation Comment B-7.1: Several commenters suggested that the proposed rule require that OROs be included in emergency planning activities, regardless of a facilitys plume exposure pathway EPZ size. One commenter noted that under the proposed rule a site boundary plume exposure pathway EPZ effectively eliminates the need for full participation exercises to test the capacity of state and local governments. The commenter explained that these exercises allow for evaluation of response capabilities and help refine and train response personnel. The commenter added that a site boundary plume exposure pathway EPZ results in the degradation of operational readiness and hampers refinement and continuous improvement of emergency plans, and that they do not believe a site boundary plume exposure pathway EPZ provides for defense in depth for the full spectrum of accident scenarios and unforeseen issues. Another commenter agreed with this commenters argument. Another commenter stated that given that SMRs and ONTs are new technologies with a limited operational history, OROs should continue to be involved in emergency planning for these facilities. According to the commenter, the consequences of a site boundary plume exposure pathway EPZ include no established relationships with local and state responders; no trained and practiced means to reduce dose that is projected to be below the 1 rem total effective dose equivalent (TEDE) threshold. The commenter asserted that without appropriate drills and exercises the risk of delays, errors and inefficiencies in response activities increases. One commenter stated that the NRC does not seem to understand that it is not just the applicant and licensee that are the foundation of 36

emergency planning, but also State and local governments and surrounding community organizations that must be trained and prepared for emergencies. (AS-3, FEMA-4, FEMA-13, FEMA-14, NJDEP-5, NJDEP-6, UW2-8, UW2-9, UW2-10, UW2-43, UW2-44)

NRC Response: The NRC disagrees with the comments. This rule is a risk-informed, consequence-oriented EP framework. A risk-informed and consequence-oriented approach considers the potential consequences from a spectrum of accidents, including those that could result in an offsite radiological release. The outcome is a graded approach to EP based on site-specific analyses. Part of this graded approach is a scalable plume exposure pathway EPZ size that is based on the NRCs review of an applicants or licensees site-specific analysis of the accident likelihood and source term, timing of the accident sequence, and meteorology.

One potential result of this EP framework is a site boundary plume exposure pathway EPZ if the applicants or licensees analysis can support one. Even in this scenario, the applicant or licensee would be required to establish an emergency classification scheme with criteria to determine the need for notification of Tribal, State, and local agencies in emergencies. If the classification scheme does not reach a severity level that would require notification of Tribal, State, and local agencies of the need to take a protective action, such as with a site boundary plume exposure pathway EPZ, then Tribal, State, and local government organizations would not need training on specialized actions in response to an event, other than providing onsite firefighting, law enforcement, and ambulance response. This is risk-informed decisionmaking.

The NRC is not saying that radiological support and training of OROs is abandoned. As described in the NRC Response to Comment B-7.2, communities can still develop and maintain radiological response capabilities without an NRC requirement for an offsite plume exposure pathway EPZ.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment B-7.2: Several commenters stated that, under the proposed rule, the NRC approval of a facility with a site boundary plume exposure pathway EPZ would leave Tribal, State, local, and Federal agencies with an all-hazards approach to EP, which would not be sufficient preparation to respond to an emergency event. Several commenters wrote that it would be unrealistic to expect that an all-hazards approach would be coordinated or effective in responding to a radiological emergency. One commenter suggested that the proposed rule merely assumes that State and local governments will respond to an accident because they are required to by State law. The commenter asserted that this is an ad hoc approach that does not ensure that the full range of necessary actions will be taken and makes it likely any response will be uncoordinated. Another commenter specifically agreed with this argument. Additionally, two commenters suggested that radiological incidents pose unique circumstances that OROs may not be prepared to confront with an all-hazards approach. One commenter agreed that while the probability of a significant radiological release from an SMR or ONT facility is low, an all-hazards approach would not sufficiently address the unique nature of a radiological incident.

One commenter said that the NRC is assuming a large, coordinated Federal response will be available to respond to an offsite emergency, but this could be problematic if multiple disasters or a broader national emergency occurs. Two commenters wrote that they support a risk-informed approach to emergency planning, and a minimum level of training and support for OROs should remain regardless of the plume exposure pathway EPZ size. Additionally, one commenter suggested this coordination could be conducted through ingestion pathway requirements as detailed in the proposed rule but more detail is required to ensure clearer understanding of the expected level of licensee coordination with the offsite organizations and the requirements for demonstration of the adequacy of these required coordination efforts.

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One commenter stated that the NRC has previously misrepresented FEMAs views on an all-hazards approach to emergency planning. The commenter asserted that the NRC has cited FEMAs Comprehensive Preparedness Guide (CPG)-101, Developing and Maintaining Emergency Operations Plans, issued November 2010, as evidence that all-hazards planning is just as effective as dedicated radiological emergency planning. The commenter stated that CPG-101 actually recommends hazard-specific procedures and planning. The commenter noted that this is also reflected in CPG-201, Threat and Hazard Identification and Risk Assessment (THIRA) and Stakeholder Preparedness Review (SPR) Guide, issued May 2018, which recommends preparing for specific threats. (BN-4, FEMA-12, NJDEP-2, NJDEP-10, CRCPD-2, IDPH-2, IDPH-3, UW2-47, UW2-48, UWF1-2, UWF1-4, UWF2-3, UWF2-4, UWF2-5, UWJB-5)

NRC Response: The NRC disagrees with the comments. The NRC is not required to assume an offsite radiological release will happen but also does not assume that the probability of an offsite release is zero. EP is risk informed rather than risk based. The risk-informed and consequence-oriented framework of 10 CFR 50.160 considers the potential consequences from a spectrum of accidents, including those that could result in an offsite radiological release and those that could not. The outcome is a graded approach to EP based on site-specific analyses.

Part of this graded approach is a scalable plume exposure pathway EPZ size that is based on the NRCs review of an applicants or licensees site-specific analysis of the accident likelihood and source term, timing of the accident sequence, and meteorology. One potential result of this EP framework is a site boundary plume exposure pathway EPZ if the applicants or licensees analysis can support one.

Whether the NRC requires offsite radiological EP depends on the size of the plume exposure pathway EPZ. If the NRC finds acceptable a site-specific analysis supporting a site boundary plume exposure pathway EPZ, then the NRC will not require a formal offsite radiological emergency plan. This approach is risk-informed decisionmaking. This approach does not abandon radiological support and training of OROs. Communities can still develop and maintain radiological response capabilities without an NRC requirement for an offsite plume exposure pathway EPZ. FEMAs CPG-101 provides guidance for developing offsite emergency plans and understanding risk-informed planning and preparedness. FEMAs CPG-201 provides communities with additional guidance for conducting a risk assessment and presents the basic steps of the process. Together, these two CPGs provide a risk-informed basis for the offsite planning effort, as well as encourage the engagement of the whole community to address risks that might impact a jurisdiction.

As described in the NRC Response to Comment B-4.8, the NRIA to the Response and Recovery FIOP in the NRF provides the Federal Governments response activities for incidents involving a release of radioactive materials. The NRIA also identifies the Federal response capability inventory, which includes radiological assets, resources, and teams available for OROs. The OROs are encouraged to incorporate Federal assets that may be used in State, local, and Tribal government emergency plans.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment B-7.3: One commenter recommended that emergency plans should clearly document the contacts and arrangements made with outside organizations, State and local governments, and other organizations. (DBY-5) 38

NRC Response: The NRC agrees, in part, with the comment. Under 10 CFR 50.160(b)(1)(iv)(B)(1), the emergency plan must describe the following:

contacts and arrangements made and documented with local, State, Tribal and Federal governmental agencies, as applicable, with responsibilities for coping with emergencies, including the identification of the principal coordinating agencies, and the coordinated reviews of changes in offsite and onsite planning and preparation.

As explained in RG 1.242, this requirement means that the emergency plan should describe the contacts and arrangements made for various OROs. This description should document the relevant emergency planning and preparations, roles, and responsibilities, including references to or attachments of agreements with the OROs. Together, the rule language and guidance address this comment. However, consistent with the performance-based nature of this rule, the NRC did not place in the rule text the prescriptive requirement suggested by the comment.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment B-7.4: Regarding drills and exercises, one commenter asked what standards would apply to offsite organizations. (DBY-6)

NRC Response: The comment assumes that the NRC would establish standards for the performance of drills and exercises by OROs. The proposed rule did not intend to define drill and exercise standards for OROs. The current Memorandum of Understanding between FEMA and the NRC describes FEMAs responsibilities as having the lead role in offsite emergency planning and preparedness activities, including assessing offsite emergency plans and preparedness and making findings and determinations as to the adequacy of the plans and whether they can be implemented (e.g., adequacy and maintenance of procedures, training, resources, staffing levels and qualifications, and equipment). FEMAs findings and determinations will be based on the review of plans and exercise results.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment B-7.5: One commenter wrote that the 1-rem TEDE over 96 hours0.00111 days <br />0.0267 hours <br />1.587302e-4 weeks <br />3.6528e-5 months <br /> criterion leaves uncertainty as to the level of offsite engagement required by licensees to demonstrate drill and exercise functions. (IDPH-7b)

NRC Response: The NRC disagrees with the comment. The need for and level of offsite engagement required by licensees to demonstrate drill and exercise functions will be determined by the size of the plume exposure pathway EPZ. The applicant or licensee will document the details of ORO engagement needs in the emergency plan. Thus, the level of engagement by OROs will be established when the NRC approves the emergency plan and issues a license. If the plume exposure pathway EPZ is at the site boundary, such that the NRC will not require offsite radiological response plans, certain capabilities that the NRC requires the licensee to demonstrate in drills or exercises will require ORO engagement to enable the licensee to demonstrate the capability. For example, 10 CFR 50.160(b)(1)(iii)(B) requires the capability to recommend protective actions to offsite authorities as conditions warrant.

Additionally, 10 CFR 50.160(b)(1)(iii)(C) requires the capability to make notifications to organizations who may have responsibilities for responding during emergencies. The specifics of OROs participation will be captured in the emergency plan.

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Accordingly, the NRC did not change the rule language in response to this comment.

Comment B-7.6: One commenter wrote that the proposed rule does not include requirements involving doctors and hospitals outside the plume exposure pathway EPZ as was the case for the development of the Blue Castle Holdings facility plume exposure pathway EPZ. (UW2-57)

NRC Response: The NRC disagrees with the comment. Under 10 CFR 50.160(b)(1)(iv)(B)(1),

emergency plans must describe contacts and arrangements made and documented with local, State, Tribal, and Federal governmental agencies, as applicable, with responsibilities for coping with emergencies. As explained in RG 1.242, these agencies include medical and other response organizations. The regulations do not place a limit on the distance from the licensees site for providers of resources identified as being needed in an applicants or licensees emergency plan. The applicant or licensee must justify the travel time to or by the resource provider or provide the resource themselves. The latter situation occurs when a facility does not have an offsite fire department in close proximity, and the licensee provides an onsite fire department.

Accordingly, the NRC did not change the rule language in response to this comment.

C. Hazard Analysis of Contiguous or Nearby Facilities10 CFR 50.160(b)(2)

General Comments on the Hazard Analysis of Contiguous or Nearby Facilities Comment C-1.1: Several commenters suggested defining some key terms more clearly in the proposed rule to improve regulatory certainty and consistency for applicants. Specifically, one commenter wrote that it is unclear what could be considered a credible hazard. One commenter suggested defining the terms nearby and adversely impact with respect to the hazard analysis to reduce uncertainty for applicants, while other commenters wrote that the NRC should better define terms such as facility, nearby, less severe, more severe, more probable, and less probable. Specifically, one commenter proposed that the NRC define the difference between more and less severe accidents, as well as the term less probable but more severe. The commenter explained that it is often the case that an accident with low probability due to multiple system failures nevertheless has very benign consequences. (DBY-7, NSA-3, NSA-4, ANS-6)

NRC Response: The NRC disagrees with the comments. Because this rule is performance based, the NRC is allowing applicants and licensees to determine which facilities are nearby and which hazards may adversely impact the implementation of the emergency plan, as those terms are used in 10 CFR 50.160(b)(2). Some of the comments concern terms used in the proposed rule Federal Register notice (FRN) to describe the plume exposure pathway EPZ size determination analysis. In response to other comments on the proposed rule (see the NRC Response to Comment D-2.1), the NRC removed the phrase spectrum of credible accidents from the plume exposure pathway EPZ size determination analysis rule text in 10 CFR 50.33(g)(2) and, as a result, removed less severe, less probable, and more severe from the final rule SOC.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment C-1.2: One commenter suggested removing the hazard analysis or clarifying its intended scope and relationship to other requirements. Specifically, the commenter wrote that the hazard analysis is redundant to the requirements in 10 CFR 100.20(b) and associated 40

application requirements such as 10 CFR 52.79(a)(1)(iv), which already require a hazard analysis and ensure that the risk from hazards is low. Additionally, the commenter wrote that the requirement suggests a hazard might arise at a nearby facility simultaneously with a licensees need to implement emergency plans, which is an unlikely scenario. Additionally, the commenter wrote that examples for the hazard analysis offered in the proposed rule, specifically notifying contiguous or nearby facilities regarding emergencies and providing for protective actions for the other facilitys personnel, are not relevant to a hazard analysis requirement.

Finally, the commenter wrote that any credible hazard should inform the plume exposure pathway EPZ size determination and emergency planning as a credible accident scenario. As a result, it is unclear why an additional hazard analysis is required. The commenter wrote that if the NRC does retain the hazard analysis requirement, then it should be clearly explained in relation to other regulatory requirements and guidance. (NSA-20, NSA-21, NSA-22, NSA-25)

NRC Response: The NRC disagrees with the comments. The intended scope of this rules hazard analysis is to assess those hazards presented by a facility that is on the same site as, contiguous to, or near the applicants or licensees facility that could adversely impact the implementation of the applicants or licensees emergency plan and, therefore, require additional EP considerations relative to an independently sited facility. For example, a nuclear power facility could be sited contiguous to or near an industrial facility to supply process heat or electrical power, or an SMR could be used to power a desalination facility located on the same site. The hazards of the non-NRC-licensed facility must be factored into the EP program of the nuclear facility to provide reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency at the nuclear facility. These hazards may not be included in the hazard analyses described in 10 CFR 100.20(b) or the application requirements in 10 CFR 52.79(a)(1)(iv).

The NRC disagrees that a hazard arising at a nearby facility simultaneously with a licensees need to implement its emergency plan is too unlikely a scenario to be considered credible.

Events such as external hazards or natural phenomena that could affect both facilities and other case-by-case events would need to be included in the hazard analysis.

The NRC disagrees that any credible hazard should inform the plume exposure pathway EPZ size determination and emergency planning as a credible accident scenario. A credible hazard is not necessarily a credible accident scenario. The accidents used to determine plume exposure pathway EPZ size are accidents at the facility. Although a hazard analysis considers hazards from the nuclear unit, the hazard analysis primarily focuses on the hazards presented by other nonnuclear, nonlicensed facilities. The hazard analysis is used to help develop planning activities or emergency response functions to address any credible hazard that would adversely impact the implementation of emergency plans.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment C-1.3: One commenter wrote that it is understood that a hazard analysis would be conducted during the siting review and asked if it is intended that EALs include the potential for nearby hazards to create an emergency. The commenter suggested the requirement be remanded to the appropriate licensing requirements and be included in EAL considerations but not necessarily an emergency planning effort. Another commenter wrote that the hazard analysis should be conducted before allowing the facility to proceed with proposed emergency plans. The commenter added that it should include hazards such as floodplains, proximity to coastline, fault lines, and seasonal weather patterns due to the concentration of cities and manufacturing near coastal areas. (RSX-7, CI-4) 41

NRC Response: The NRC agrees, in part, with the comments. Although a hazard analysis is conducted under 10 CFR Part 100, Reactor site criteria, for the siting of a nuclear power reactor, that siting hazard analysis is not the same as the hazard analysis required by 10 CFR 50.160(b)(2). The hazard analysis performed for this rule evaluates hazards that have the potential to negatively impact the implementation of the emergency plan and not those hazards that could create an emergency. The NRC agrees that EALs include the potential for nearby hazards to create an emergency; however, the EALs may not be specific to the identified nearby hazard. For example, flooding from a dam failure could be a nearby hazard but flooding from a dam failure may not be the only potential source of flooding. A break in a cooling water system pipe could also be a source of flooding. Therefore, the licensee may have a generic flooding EAL instead of a specific dam failure EAL.

The NRC disagrees that the hazard analysis should be conducted before a facility proceeds with proposed emergency plans. The hazard analysis is part of the emergency plan and likely would need to be performed before the completion of the emergency plan. Nevertheless, the NRC does not require the order in which an applicant or licensee creates the content of its application. The NRC disagrees that the hazard analysis required by 10 CFR 50.160(b)(2) should include hazards such as floodplains, proximity to coastline, fault lines, and seasonal weather patterns due to the concentration of cities and manufacturing near coastal areas.

These types of hazards would be evaluated in the siting hazard analysis or environmental impact assessment.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment C-1.4: Two commenters suggested that the proposed rule should require a hazard analysis and emergency planning for multiple-unit or mixed facilities. Both commenters cited the Fukushima incident as an event where a natural disaster compromised more than one reactor. One commenter noted that SMRs are often sited in close proximity to each other and responding to an incident at one reactor is vastly different from responding to multiple events at several reactors. Another commenter stated that multimodule planning is necessary despite design and safety justifications for individual modules. (NJDEP-9, UCSJT-5)

NRC Response: The NRC agrees with the comments. The hazard analysis required by 10 CFR 50.160(b)(2) includes any credible hazard that would adversely impact the implementation of the emergency plan. As explained in RG 1.242, the analysis should include the site-specific hazards posed by multimodular and nuclear units and nearby, adjacent, or contiguous facilities that could complicate the licensees emergency response. Further, each module source term must be part of the aggregate considered in the dose consequence analysis for determining the spectrum of accidents for the entire facility as part of the EPZ sizing determination.

Accordingly, the NRC did not change the rule language in response to these comments.

NRC Question: To what extent should this analysis be harmonized with or rely upon the analysis conducted under 10 CFR 100.20, Factors to be considered when evaluating sites, for man-related hazards?

Comment C-2.1: Several commenters recommended that the regulations under 10 CFR Part 100 should apply to SMRs and ONTs. One commenter suggested that an applicant should be able to rely on and reference the requirements under 10 CFR 100.20 and 42

10 CFR 100.21, Non-seismic site criteria, to meet the proposed rules hazard analysis requirements. The commenter also wrote that the NRC should also be aware that the draft guidance under development for the currently in-progress rulemaking on Alternative Physical Security Requirements for Advanced Reactors will likely include a hazard analysis focused on assessing impacts to security-related design features. (NJDEP-20, NJDEP-21, NEIA-10, CRCPD-20, CRCPD-21, IDPH-11 IDPH-12)

NRC Response: The NRC agrees, in part, with the comments. The NRC agrees that 10 CFR Part 100 should apply to SMRs and ONTs within the scope of this rule, and it already does apply to them. Part 100 applies to power and testing reactors, as those terms are defined in 10 CFR 100.3, licensed under 10 CFR Part 50 or 10 CFR Part 52.

The NRC disagrees that an SMR or ONT applicant should be able to rely on and reference the analysis required under 10 CFR Part 100 to meet the hazard analysis requirement in 10 CFR 50.160(b)(2). The 10 CFR Part 100 analysis evaluates the effects of certain external hazards on the design, operation, and engineering of the site and facility, whereas the hazard analysis under 10 CFR 50.160(b)(2) would assess the effects of certain hazards on the implementation of the applicants emergency plan. Although the two analyses may use some of the same inputs, they serve different purposes. Therefore, it is unlikely that an SMR or ONT applicant could rely on or reference the analysis required under 10 CFR Part 100 to meet the hazard analysis requirement in 10 CFR 50.160(b)(2).

Although the Alternative Physical Security Requirements for Advanced Reactors rulemaking (Docket Number NRC-2017-0227, RIN 3150-AK19) may involve a hazard analysis that assesses the impacts on security-related design features, it probably would not be a hazard analysis like the one in 10 CFR 50.160(b)(2). The hazard analyses in the two rulemakings will apply to different licensee programs (physical security and EP) and likely focus on different types of hazards.

Accordingly, the NRC did not change the rule language in response to these comments.

NRC Question: What kinds of facilities might be located contiguous or nearby to SMRs or ONTs?

Comment C-3.1: One commenter expressed support for the hazard analysis requirements and urged that the hazard analysis include consideration of Tribal customs in any planned or actual land use to alleviate potential cultural and religious risks or perceptions. (SBT-22)

NRC Response: The NRC agrees, in part, with the comment. Facilities contiguous to or near an SMR or ONT could have hazards with the potential to adversely impact the emergency planning, and the implementation of those plans, not only of the SMR or ONT but also State, local, and Tribal governments located near the SMR or ONT. For this reason, the NRC is requiring an applicant or licensee to include in its application a hazard analysis under 10 CFR 50.160(b)(2). However, this hazard analysis would not consider land use as suggested by the comment. The analysis would focus on potential hazards that could adversely impact the implementation of emergency plans at the SMR or ONT facility. Land use issues are addressed by the NRC through the National Environmental Policy Act (NEPA) process during licensing reviews.

Accordingly, the NRC did not change the rule language in response to this comment.

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Comment C-3.2: One commenter supplied several online sources describing applications that could involve a nearby or contiguous facility, including the International Atomic Energy Agency (IAEA) Web page, information on nonelectric applications, a World Nuclear Organization Web page, and information on Nuclear Process Heat for Industry. (NEIA-11)

NRC Response: The NRC reviewed the information provided in response to this Specific Request for Comment. The Web sites described some facilities that could be located on the same site as or near an SMR or ONT and were not mentioned in the proposed rule FRN.

However, any hazards presented by these nonnuclear facilities would be evaluated by the hazard analysis required by the rule.

Accordingly, the NRC did not change the rule language in response to this comment.

NRC Question: Should the NRC change the scope of the hazard analysis? If so, how should the scope of the hazard analysis change?

Comment C-4.1: Two commenters indicated that the NRC should not change the scope of the hazard analysis. (NJDEP-22, CRCPD-22)

NRC Response: The NRC agrees with the comments. The scope of the hazard analysis in the proposed rule would be sufficient to evaluate the potential adverse impacts on a licensees implementation of its emergency plan from hazards presented by facilities located on the same site as, contiguous to, or near the SMR or ONT.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment C-4.2: One commenter indicated that the scope of the hazard analysis should be expanded to support a native dietary and ethnographic study of wildlife and plants consumed in Native American diets or tied to religious ceremonies. In addition, the commenter wrote that the proposed rule should include site-specific hazards, associated or not associated with nonnuclear facilities, that require expansion of existing emergency plans. Finally, the commenter urged enhancement of the notification process to Federally recognized Tribes that may be located within or near the plume exposure pathway EPZ or IPZ. (SBT-23, SBT-24)

NRC Response: The NRC disagrees with the comments. The NRC disagrees that the scope of the hazard analysis should be expanded. Analysis of the potential effects of a reactor site on the environment such as native dietary and ethnographic study of wildlife and plants consumed in Native American diets or tied to religious ceremonies is performed under 10 CFR Part 51, Environmental protection regulations for domestic licensing and related regulatory functions, and is outside the scope of this rulemaking.

The NRC disagrees that the notification process to Federally recognized Tribes located within or near the plume exposure pathway EPZ or IPZ should be enhanced. Under 10 CFR 50.160(b)(1)(iv)(B)(1), the emergency plan must include the contacts and arrangements made and documented by the applicant or licensee with local, State, Tribal, and Federal governmental agencies, as applicable, with responsibilities for coping with emergencies. Under 10 CFR 50.160(b)(1)(iv)(B)(2), the emergency plan must describe the means by which the licensee would notify these organizations in the event of an emergency. Therefore, if a Federally recognized Tribe has a responsibility for coping with emergencies within the scope of the applicants or licensees emergency plan, then the licensee would notify that Tribe as applicable to the Tribes responsibilities during a given emergency. The regulations do not 44

place a limit on the distance from the licensees site for providers of resources identified as being needed in an applicants or licensees emergency plan.

The comment that the rule should include site-specific hazards, associated or not associated with nonnuclear facilities, that require expansion of existing emergency plans is outside the scope of this rulemaking because this rulemaking does not propose any changes to existing emergency plans. However, under the requirements of 10 CFR 50.54(q) and 10 CFR 50.160, licensees complying with 10 CFR 50.160 are required to maintain the effectiveness of their emergency plans, which includes updating a hazard analysis, as necessary.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment C-4.3: One commenter suggested flexibility in determining which hazards should be assessed as part of the licensing process, specifically for hazards that may not be immediately present. The commenter offered the example of a facility able to accommodate six modules but initially licensed with just two modules, writing that the applicant should be able to conduct a hazard analysis referencing only two modules and update it later as other units are added. The commenter also offered the example of a dual-purpose facility initially licensed with only one form of production. (NEIA-12)

NRC Response: The NRC agrees, in part, with the comment. The NRC issues individual licenses for reactors, notwithstanding the reactors configurations. For example, an applicant that submits one application for three reactor licensesto be constructed modularly or on contiguous siteswill result in three separate docket numbers, three separate license numbers (if all three are issued licenses), etc. The hazard analysis for that application could consider future reactors on, contiguous to, or near that site, but a future license application would still need a hazard analysis specific for that application. So, if a licensee holds licenses for three modules and wants to add another reactor at the site, then that licensee would need to submit a license application for the additional reactor and that additional application would be required to include a hazard analysis applicable to that proposed reactor. In addition, the licensee would need to update its hazard analyses for the existing three reactors to reflect the fourth reactor as required under 10 CFR 50.160(b)(1)(i) and 10 CFR 50.54(q)(2)(ii). These provisions require a licensee to maintain the effectiveness of its emergency plan. Similarly, if a nonnuclear facility is added to a reactor site or a contiguous or nearby site after the NRC licenses the reactor, then the licensee would need to update its hazard analysis as required under 10 CFR 50.160(b)(1)(i) and 10 CFR 50.54(q)(2)(ii).

Accordingly, the NRC did not change the rule language in response to this comment.

Comment C-4.4: To adjust the scope of the hazard analysis, one commenter suggested clarifying the definitions of nearby and credible hazards, which could be subjective. (HF-6)

NRC Response: The NRC disagrees with the comment. Because this rule is performance based, the NRC is allowing applicants and licensees to determine which facilities are nearby and which hazards are credible. The NRC will review the applicants or licensees use of those terms when the NRC reviews the applicants or licensees emergency plan and whether the hazards would adversely impact the implementation of the emergency plan.

Accordingly, the NRC did not change the rule language in response to these comments.

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Comment C-4.5: One commenter urged the NRC to consider unknowns and uncertainties in developing guidelines for SMRs and ONTs given their limited operational history. The commenter suggested expanding the hazard analysis to include low-probability events, security considerations, combined emergency scenarios, and other beyond-design-basis events.

(UCSJT-4)

NRC Response: The NRC agrees, in part, with the comment. Low-probability events, combined emergency scenarios, and other beyond-design-basis events can include different types of hazards and events. Certain categories of low-probability events, combined emergency scenarios, and other beyond-design-basis events would be included in the case-by-case determinations of a hazard analysis, and other types of these events would be part of the analysis used to determine the size of the plume exposure pathway EPZ. These are two different types of analyses with different purposes. However, security considerations are not within the scope of this rule.

Accordingly, the NRC did not change the rule language in response to these comments.

D. Scalable Approach for Determining the Plume Exposure Pathway Emergency Planning Zone Size10 CFR 50.160(b)(3)

General Comments on the Scalable Approach for Determining the Plume Exposure Pathway Emergency Planning Zone Size Comment D-1.1: Several commenters, including a form letter campaign, expressed support for a risk-informed, performance-based, and consequence-oriented approach to plume exposure pathway EPZs that reflects the advanced safety features and reduced source terms of SMRs and ONTs. Several commenters wrote that the proposed rule would introduce plume exposure pathway EPZ size requirements that would be commensurate with the risk posed by SMR technology. Several commenters wrote that the proposed rule would still retain a high level of EP protection to the public. A couple of commenters wrote that appropriate regulations for advanced technologies would have a positive impact on the development of clean energy and climate change. One commenter wrote that linking a specific plume exposure pathway EPZ size to power reactor levels, as called for by some commenters, is an arbitrary and deterministic framework. A form letter campaign contended that the NRC has decades of experience regulating hundreds of small-scale reactors with no serious release to date and therefore is well suited to regulate SMRs and other advanced reactors. One commenter highlighted progress toward the Tennessee Valley Authority Clinch River early site permit (ESP), which includes plume exposure pathway EPZ sizing in alignment with the proposed rule. One commenter suggested that the NRC study modeling failure and size the EP plan appropriately. (AMX-1, DOE1-1, DOE1-5, JH-3, GHX-2, BGX-1, AS-1, CMXA-1, NIA-1, NIA-2, CLA-2, NM1-1, NM1-2, NM2-2, NM1-3, NNSA2-1, FL2-3)

NRC Response: The NRC agrees, in part, with the comments. The performance-based, technology-inclusive, risk-informed, and consequence-oriented approach to EP requirements for SMRs and ONTs are commensurate with the potential consequences to public health and safety posed by these facilities. However, the NRC did consider power level along with other factors such as accident source term, fission product release, and associated dose characteristics. The credits for smaller sized reactors are framed in the potential benefits associated with postulated accidents, including slower transient response times, and relatively small and slow release of fission products.

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Accordingly, the NRC did not change the rule language in response to these comments.

Comment D-1.2: Several commenters supported a scalable plume exposure pathway EPZ size for SMRs and ONTs to expand the countrys nuclear energy capabilities and reduce the use of combustible energy sources. Several commenters stated that SMRs and advanced nuclear technologies should not be overregulated and emphasized the need for scalable plume exposure pathway EPZ requirements to increase adoption of nuclear energy. Several commenters also related this to the role of nuclear energy in combatting climate change. One commenter said that all emergency planning activities should be informed by what is necessary to meet the consistent and objective public exposure limit and that a reduced potential source term should be considered in all plans, which could be addressed by having smaller plume exposure pathway EPZ sizes and response plans. Another commenter said that the proposed rule will reduce unnecessary public and private costs associated with larger-than-necessary EPZs and reduce costs for other Federal, State, and local agencies. Finally, one commenter suggested that the proposed rule would have a positive impact on the economic viability, commercialization, and deployment of the new advanced nuclear plants. (AE-1, AMX-2, JH-3, TS-2, TQ-1, TQ-3, GL-1, NR-3, NIA-3, NNSA2-8)

NRC Response: The NRC agrees, in part, with the comments. Licensees emergency plans under 10 CFR 50.160 will be informed by the source term and limits on the publics exposure to dose. Objectives for the final rule include provisions for reasonable assurance that adequate protective measures can and will be taken by an SMR or ONT licensee in the event of a radiological emergency at the facility and that the rule will promote regulatory stability, predictability, and clarity. However, the promotion of nuclear power, for any reason, is not one of the purposes of this rulemaking nor is it permissible under the NRCs statutory authority.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment D-1.3: Several commenters, including a form letter campaign, expressed opposition to what they described as the reduction or elimination of plume exposure pathway EPZ requirements for SMRs. Several commenters wrote that the proposal would be a significant risk to public health and safety. Several commenters, including a form letter campaign, stated that the proposed regulation would reverse over 40 years of emergency planning protections. One commenter suggested that the proposed changes have met opposition within the NRC and FEMA as well. One commenter wrote that the proposed requirements would put communities and the environment at risk in favor of untested and hypothetical technologies. One commenter said that the proposed rule would allow licensees to essentially determine their own plume exposure pathway EPZ size and eliminate offsite emergency planning, while a form letter campaign stated that the NRC is opening the door to any nuclear facility eliminating emergency planning based on a risk calculation. One commenter claimed that reducing the size of plume exposure pathway EPZs for SMRs and ONTs would not provide stability, predictability, and clarity; instead, that comes from the NRCs historic reliance on plume exposure pathway EPZs and offsite emergency plans. One commenter called the proposed approach arbitrary and not protective of public health and safety. One commenter asserted that the nuclear industry is not a safe form of energy production and never will be. The commenter stated that the NRC should require strong emergency planning for nuclear reactors. (KM-1, JL-3, JL-4, SL2-2, BRM-1, SRA-1, SRA-3, UW2-15, UW2-23, UW2-46, UW2-51, UW2-52, UW2-64, UCSJT-1, FL1-3, FL1-9)

NRC Response: The NRC disagrees with the comments. The NRC is preparing for the evolving future of advanced nuclear power reactors, which includes the development of a 47

graded approach to EP for SMRs and ONTs. While EP continues to evolve, the NRCs mission, values, and Principles of Good Regulation remain the grounding forces for the agency to ensure that the publics health and safety are maintained.

The NRC disagrees that the rule is a radical departure from current radiological EP requirements when using a scalable approach. First, the applicant or licensee has the option to use the current EP framework instead of 10 CFR 50.160. Second, the performance-based EP framework provides requirements for determining the size of the plume exposure pathway EPZ and describing ingestion response planning in the emergency plan, which would apply the same dose standard for predetermined, prompt protective measures to SMR or ONT facilities as is required of the current operating LLWR and non-power reactor facilities. The scalable methodology in the final rule is consistent with NUREG-0396/EPA 520/1-78-016, Planning Basis for the Development of State and Local Government Radiological Emergency Response Plans in Support of Light Water Nuclear Power Plans, issued December 1978 (ADAMS Accession No. ML051390356), which is also the basis for the current EP requirements for operating LLWRs.

The rules performance-based EP framework for SMR and ONT facilities under 10 CFR 50.33(g)(2) requires each applicant or licensee to justify to the NRC the technical basis for the applicants or licensees proposed plume exposure pathway EPZ size. The applicants or licensees justification analysis for the plume exposure pathway EPZ size must include an assessment of the likelihood of facility-specific accidents in association with public dose consequences. One of the requirements is that projected doses are within the 1-rem TEDE per 96-hour criterion, which must be used in the analysis for the determination of the plume exposure pathway EPZ area, with consideration of conditions such as demography, topography, land characteristics, access routes, and jurisdictional boundaries for an offsite plume exposure pathway EPZ.

The applicant or licensee must use a systematic assessment employing a method that is deterministic, mechanistic, or a combination of these methods in a risk-informed rather than risk-based approach to arrive at the required consideration of the likelihood of accidents. The NRC reviews the applicants or licensees assessment of licensing-basis events, event likelihood, and public dose consequences as part of the NRCs safety review of the license application, which the NRC expects to be the typical form of a request to use the EP framework of 10 CFR 50.160. The NRCs determination of the acceptability of the applicants or licensees assessment supports the separate review of the applicants or licensees emergency plans.

The NRC disagrees that the requirements of the rule would place communities and the environment at risk in favor of untested and hypothetical technologies. The NRC has regulatory processes to address new technologies. As explained in the NRC Response to Comment A-2.2, under 10 CFR 50.43(e), the NRC requires the demonstration of the performance of safety features of new reactor designs before approving the designs.

The NRC maintains that the risks posed by SMRs and ONTs are consistently and commensurately lower in comparison with the well understood radiological risks associated with other reactors operating power levels. These SMR and ONT designs are expected to demonstrate increased safety margins for the smaller source terms, thereby reducing the radiological risk to the public.

Accordingly, the NRC did not change the rule language in response to these comments.

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Comment D-1.4: Several commenters requested that the rule maintain the 10-mile plume exposure pathway EPZ boundary for SMRs and ONTs. Several commenters stated that this would best protect public safety, with one commenter writing that this would be an appropriate approach given that SMRs are still an unproven technology. (DBX-1, SSX-1, AN4-1, KK-1, UW2-58, UW2-60)

NRC Response: The NRC disagrees with the comments. The NRC has long permitted options besides a 10-mile plume exposure pathway EPZ for utilization facilities other than LLWRs because the radiological hazards to the public associated with these facilities operations involve considerations different than those associated with LLWRs. Regulations under the current EP framework in 10 CFR 50.33(g) and 10 CFR 50.47(c)(2) provide that the size of plume exposure pathway EPZs for gas-cooled nuclear reactors and for reactors with an authorized power level less than 250 MW(t) may be determined on a case-by-case basis because of the lower potential hazard from these facilities (i.e., lower radionuclide inventory and longer times to release significant amounts of activity in many scenarios).

The NRC has licensed several small reactors with a reduced plume exposure pathway EPZ size of 5 miles (8 kilometers). These reactors include the Fort St. Vrain Nuclear Generating Station high-temperature gas-cooled reactor (842 MW(t)), the Big Rock Point boiling-water reactor (BWR) (240 MW(t)), and the La Crosse BWR (165 MW(t)). Additionally,Section I.3 of Appendix E to 10 CFR Part 50 states that the plume exposure pathway EPZs for facilities other than power reactors, such as RTRs, may also be determined on a case-by-case basis.

Because of the very low potential hazard to the public, RTRs do not have a 10-mile plume exposure pathway EPZ.

The performance-based EP framework includes the determination of a scalable plume exposure pathway EPZ size instead of a fixed 10-mile plume exposure pathway EPZ size for all reactor technology designs. The scalability of the plume exposure pathway EPZ area is based on dose consequence criteria; accident likelihood and source term; timing of the accident sequence; meteorology; and the need for predetermined, prompt protective measures. An applicant or licensee must propose and justify a plume exposure pathway EPZ size as part of its emergency plan, and the NRC must approve the entire emergency plan before the licensee will be able to implement the emergency plan.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment D-1.5: Several commenters stated that the proposed plume exposure pathway EPZ size requirements as written would prevent FEMA from evaluating and assessing the adequacy of offsite emergency plans. Additionally, two commenters wrote that the proposed rule would allow facilities to eliminate emergency planning outside the site boundary with limited oversight from FEMA, endangering public safety and health. One commenter stated support for reducing the size of the plume exposure pathway EPZ for SMRs but found that a plume exposure pathway EPZ at the site boundary would hinder Federal oversight and FEMAs ability to determine offsite reasonable assurance that the public health and safety are protected. One commenter said that in addition to a lack of oversight from FEMA, the proposed regulations do not clearly describe the process for establishing plume exposure pathway EPZs and would rely on the licensee to provide an estimate of the source term, the full spectrum of credible accidents, and the hazard analysis. Finally, one commenter opposed the proposed scalable approach and suggested that FEMA, in addition to Federal, State, and local entities, must be involved in protective measures for EP. (FEMA-2, SRA-2, MDP-1, UCSJT-6, TKX-1, UW2-14) 49

NRC Response: The NRC disagrees with the comments. The risk-informed and consequence-oriented framework of 10 CFR 50.160 considers the potential consequences from a spectrum of accidents, including those that could result in an offsite radiological release and those that could not. The outcome is a graded approach to EP based on site-specific analyses.

Part of this graded approach is a scalable plume exposure pathway EPZ size that is based on the NRCs review of an applicants or licensees site-specific analysis of the accident likelihood and source term, timing of the accident sequence, and meteorology. One potential result of this EP framework is a site boundary plume exposure pathway EPZ if the applicants or licensees analysis can support one.

Whether the NRC requires offsite radiological EP is based on the size of the plume exposure pathway EPZ. If the NRC finds acceptable a site-specific analysis supporting a site boundary plume exposure pathway EPZ, then the NRC will not require a formal offsite radiological emergency plan and FEMA evaluation of those plans. This approach is no different than the current one involving facilities such as RTRs. The NRC may find that the applicants or licensees analysis does not support a site boundary plume exposure pathway EPZ, thereby requiring offsite radiological EP. This is risk-informed decisionmaking.

The NRC is not saying that communities surrounding a nuclear facility with a site boundary plume exposure pathway EPZ could not have emergency response plans. Communities can still develop and maintain response capabilities, including radiological response capabilities, without an NRC requirement for an offsite plume exposure pathway EPZ. FEMAs CPG-101 provides guidance for developing offsite emergency plans and understanding risk-informed planning and preparedness. FEMAs CPG-201 provides communities with additional guidance for conducting a risk assessment and presents the basic steps of the process. Together, these two CPGs provide a risk-informed basis for the offsite planning effort, as well as encourage the engagement of the whole community to address risks that might impact a jurisdiction.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment D-1.6: One commenter wrote that emergency planning for SMRs and ONTs is necessary despite the low risk posed by nuclear reactors because minimal emergency planning may cause the public to over-evacuate, emergency planning offers defense-in-depth protection against unforeseen events, and the public demands some form of emergency planning.

However, the commenter highlighted the Fukushima incident as an example of excessive action leading to unnecessary fatalities. The commenter also stated that authorities recommended 50-mile evacuations during the Fukushima incident due to concerns about spent fuel pools, but this was unwarranted given the nature of the limited risk posed by spent fuel pools.

Accordingly, the commenter said that if SMR or ONT designs include a spent fuel pool, emergency plans should make it clear that plans developed for accidents involving the reactor core encompass accidents originating in the spent fuel pool. (MU-1, MU-10)

NRC Response: The NRC disagrees with the comments. The decisions for evacuation and sheltering during an event are made and implemented by OROs, which include government officials. The NRC does not have the authority to mandate that the public take protective actions such as sheltering or evacuation during an event. However, the NRC requires its licensees to provide technical information and protective action recommendations to those government officials and OROs. The plume exposure pathway EPZ sizes are established for use in emergency planning to ensure that prompt and effective actions can be taken for public protection, whether on site or off site, as applicable. OROs are responsible for implementing appropriate protective actions such as sheltering or evacuation for beyond the site boundary 50

plume exposure pathway EPZs, when necessary. Protective action implementation for a site boundary plume exposure pathway EPZ is the sole responsibility of the licensee. The proposal for plume exposure pathway EPZ size determination includes several factors, such as low dose consequence that considers accident likelihood and source term, timing of the accident sequence, and meteorology. Regarding the spent fuel pool comment, please refer to NRC Response to Comment D-1.12.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment D-1.7: One commenter stated that the rationale for smaller plume exposure pathway EPZs for SMRs is based on the assertion that SMRs have smaller source terms. However, the commenter said that this ignores the likelihood that multiple SMR modules would be grouped together in a single facility and would therefore not have a smaller source term. The commenter offered the example of NuScales plans to build 12 50-megawatt (MW) reactors in a single chamber, which would be larger than many commercially operating nuclear reactors.

Additionally, the commenter said that small reactor modules produce more spent fuel than traditional reactors per unit of electricity, so a dozen small modular reactors operating on various schedules would result in a significant amount of very hot spent fuel in the pool at any given time. The commenter stated that the NRC cannot ignore the cumulative size and impacts of these reactors. (SRA-12, SRA-13, SRA-14, SRA-15, SRA-16)

NRC Response: The NRC disagrees with the comments. The final rule requires that applicants and licensees account for multiple reactors at a single SMR facility, as described in the NRC Response to Comment C-1.4. The final rule also requires that applicants and licensees consider all radionuclide sources, including spent fuel pools, as described in the NRC Response to Comment D-1.12.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment D-1.8: Two commenters noted that the NRC cites previous examples of small LWR and non-LWR applicants who requested exemptions from emergency planning requirements for a reduced plume exposure pathway EPZ. However, one commenter stated that in none of these examples did the NRC authorize a site boundary plume exposure pathway EPZ. One commenter highlighted that both NRC and FEMA regulations recognize the potential for smaller plume exposure pathway EPZ sizes on a case-by-case basis; however, the commenter is unaware of the NRC licensing any commercial facility with a site boundary plume exposure pathway EPZ. The commenter stated that it does not support a 0-mile or site boundary plume exposure pathway EPZ due to the lack of offsite EP and stated that there are unique challenges accompanying a response to a radiological emergency at nuclear power facilities. Another commenter said that FEMA has previously expressed concern about a site boundary plume exposure pathway EPZ for commercial nuclear reactor facilities. As a result, the commenter suggested that the proposed methodology does not maintain the same level of protection as a 10-mile plume exposure pathway EPZ and that a methodology for plume exposure pathway EPZ sizing that accounts for nontechnical variables is more appropriate. (FEMA-8, FEMA-10, UWF2-2)

NRC Response: The NRC agrees, in part, with the comments. The NRC agrees that it has not licensed a commercial nuclear power reactor facility with a plume exposure pathway EPZ area only at or within the facilitys site boundary. The NRC disagrees that the EP program permitted under 10 CFR 50.160 would not provide the same level of protection as a 10-mile plume exposure pathway EPZ. Although the NRC allows for a scalable plume exposure pathway EPZ 51

size under 10 CFR 50.33(g)(2), that approach does not guarantee that the plume exposure pathway EPZ will be less than 10 miles. More importantly, for any plume exposure pathway EPZ under 10 CFR 50.33(g)(2) and 10 CFR 50.160, the NRC applies to SMRs and ONTs the same dose standard for predetermined, prompt protective actions (e.g., evacuation, sheltering) as is required of the current operating LLWRs. As a result, the dose consequence to the public would be similar, and therefore, human health impacts would be similar. By maintaining this consistency, the regulations in 10 CFR 50.33(g)(2) and 10 CFR 50.160 afford the same level of protection of the public health and safety as the current regulatory framework does.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment D-1.9: One commenter stated that the proposed rule should consider the capabilities of Tribes near plume exposure pathway EPZs including personnel, resources, and budgets, and also consider how plume exposure pathway EPZs impact the ancestral lands of Tribes that have been relocated. Additionally, the commenter wrote that the NRC should develop a policy for site familiarization training to develop proactive relationships and coordination with Tribes if there is a need for an EP response. (NETWG-1, NETWG-2, NETWG-3)

NRC Response: The NRC disagrees with the comments. For an applicant to receive a license, the NRC must first make a finding of reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency. When applicable, the NRC makes this determination in consultation with FEMA, which includes a review of FEMAs determination of the adequacy of offsite EP. In the final rule, 10 CFR 50.33(g)(2)(i) and (ii) requires an applicant to submit the emergency response plans of State, local, and participating Tribal governmental entities in the United States that are wholly or partially within the plume exposure pathway EPZ. FEMA reviews these plans and makes a determination of reasonable assurance that adequate offsite protective measures can and will be taken in a radiological emergency. If FEMAs review of a given Tribes emergency plan reveals a deficiency that prevents a finding of reasonable assurance (e.g., lack of dedicated personnel, lack of available resources), the applicant would need to determine how to address the deficiency noted in FEMAs evaluation of the Tribes emergency plan. This process would include government-to-government consultation involving the Tribes, FEMA, and the NRC, as appropriate.

Regarding Tribes with ancestral ties to a plume exposure pathway EPZ, the NRC will engage in outreach and consultation with the Tribes on EP during individual licensing proceedings in accordance with the agencys Tribal Policy Statement and Tribal Protocol Manual.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment D-1.10: One commenter and a form letter campaign suggested that the plume exposure pathway EPZ size should be expanded rather than reduced and provided the Fukushima incident as an example. The form letter campaign stated that current emergency planning requirements under 10 CFR 50.33 have been proven to be inadequate in real-world situations. The commenters highlighted that the radiation exposure from the Fukushima disaster expanded beyond 10 miles, and the U.S. Government recommended that U.S. citizens within 50 miles evacuate. The commenters also explained that there are still restrictions on consumption of crops and food located more than 1,000 miles from Chernobyl. (GM-2, FL1-7)

NRC Response: The NRC disagrees with the comments. The NRC addressed similar comments and requests in a petition for rulemaking designated as PRM-50-104 (ADAMS 52

Accession No. ML12048B004). The petitioner requested that the NRC amend its regulations to expand existing plume exposure pathway EPZs around nuclear power plants and create a new type of plume exposure pathway EPZ. The NRC denied the petition, concluding that the current size of the plume exposure pathway EPZs is appropriate for existing reactors and proposed new reactors and that emergency plans will provide an adequate level of protection of the public health and safety in the event of an accident at a nuclear power plant (Emergency Planning Zones; Petition for rulemaking; denial (79 FR 19501; April 9, 2014)).

In comparison with current operating reactors, SMR and ONT designs that must be approved by the NRC in a license application are expected to include technological advancements embedded in design features; safety enhancements in evolutionary and passive systems; smaller sized source terms that may provide potential benefits associated with postulated accidents, including slower transient response times; and relatively small and slow release of fission products. Such design features could provide for the EP planning necessary to reflect the lower potential radiological hazards associated with the operation of these facilities compared to LLWRs. Additionally, these features would become inputs to the site-specific analysis that would provide the basis for establishing plume exposure pathway EPZ sizes.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment D-1.11: Two commenters expressed concern over reducing plume exposure pathway EPZ sizes given the lack of operational history for SMRs. One commenter said that plume exposure pathway EPZs are designed to provide a defense-in-depth approach to low-probability and high-consequence events. The commenter wrote that as a result it would not be appropriate to reduce plume exposure pathway EPZ requirements given that the NRC has not approved any SMR designs and there is so little data on SMR technology. The other commenter asked if the European Union was already running this modular design with reduced offsets; the commenter expressed that it would be more comfortable with the proposed regulations if this was the case. If not, the commenter proposed that a reactor be built with the existing safety regulations and demonstrate safe operation for a few years before the NRC revises the regulations. (WSY-2, NJDEP-1)

NRC Response: The NRC disagrees with the comments. The NRC is not currently aware of an SMR or ONT facility licensed in the European Union under a performance-based EP framework similar to the one in this rulemaking. The NRC disagrees that the absence of operational design data makes SMR and ONT designs unsafe because there are regulatory requirements for one-of-a-kind reactors to demonstrate that they can operate safely. As explained in the NRC Response to Comment A-2.2, 10 CFR 50.43(e) requires the demonstration of the performance of safety features of new reactor designs before approving the designs, and the NRC is maintaining its defense-in-depth philosophy with this rulemaking.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment D-1.12: One commenter said that the NRC is not considering accidents and radioactive releases associated with the storage of nuclear fuel in spent fuel pools. The commenter discussed concerns about the types of thin-walled canisters that hold irradiated fuel.

The commenter cited Holtec cannisters and noted that both the NRC and Holtec have expressed concerns about the canister that was not designed for cracks to be found, repaired, maintained, or monitored to prevent radioactive leaks. (UW2-7) 53

NRC Response: The NRC disagrees with the comment. In the analysis for determining the spectrum of accidents to be used in support of the facilitys emergency plan, the applicant or licensee must consider all radionuclide sources as explained in the NRC Response to Comment C-1.4. Depending on the design of the facility, this analysis could include a spent fuel pool. Comments concerning the design of spent fuel canisters are outside the scope of this rulemaking.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment D-1.13: One commenter supported the proposed approach, noting that current regulations are designed for LLWRs and do not address the advances in designs and safety offered by SMRs and ONTs. The commenter suggested that the current 10-mile plume exposure pathway EPZ standard is based on NUREG-0396, which applied design, source term, risk, and consequence analyses information using available analytical tools that reflected the characteristics of large LWR technologies. The commenter highlighted that SMR developers are incorporating advanced safety designs with inherent, passive safety features to improve plant resistance to design-basis and beyond design-basis accidents [BDBAs] and to assure any potential offsite dose is minimized. As a result, the commenter wrote that the probability of a significant release of radioactive material is projected to be significantly lower compared to the probability for LLWRs, and the NRCs approach relies on an analysis of projected offsite dose from a range of design-specific potential accidents with radiological releases to establish a pre-determined plume exposure pathway EPZ to inform protective actions. (DOE1-2)

NRC Response: The NRC agrees with the comment. The NRC agrees that certain existing regulations and guidance are focused on LLWRs and non-power reactors. The NRC also agrees that the alternative EP requirements and guidance recognize advances in design and technological advancements embedded in design features, credit safety enhancements in evolutionary and passive systems, and credit the potential benefits of smaller sized reactors and non-LWRs associated with postulated accidents, including slower transient response times, and relatively small and slow release of fission products.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment D-1.14: One commenter asked if an LLWR with a 10-mile plume exposure pathway EPZ could use the exemption request process to replace plume exposure pathway EPZ requirements under 10 CFR 50.47, Emergency plans, with the requirements under 10 CFR 50.160 if the facility is located adjacent to an SMR with a 10-mile plume exposure pathway EPZ. The commenter stated that this assumes that an LLWR and SMR have the same offsite radiological risks which justifies a 10-mile plume exposure pathway EPZ. The commenter requested that the answer be based on a purely technical comparison between the LLWR and the SMR, rather than merely citing the definition and exclusion of LLWRs in the proposed 50.160 licensing rule. (BM-13)

NRC Response: An existing LLWR could not use the exemption process under 10 CFR 50.12, Specific exemptions, to transition to the EP requirements under 10 CFR 50.160. Large LWRs were not included in the scope of this rule, not because of the potential radiological consequence posed by a LLWR, but because an EP licensing framework already exists for LLWRs and current LLWR licensees have not expressed an interest in changing the current framework. Comments concerning a performance-based, consequence-oriented approach to 54

EP for entities besides SMRs and ONTs are addressed in the NRC responses to comments in Section H of this document.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment D-1.15: One commenter stated that the proposed rule would turn over responsibility for establishing plume exposure pathway EPZs to nuclear facilities themselves and suggested that the NRC is opting out of its responsibility to protect public health and safety. (RR-1)

NRC Response: The NRC disagrees with the comment. The AEA authorizes the NRC to license and regulate the Nations civilian use of radioactive materials to provide reasonable assurance of adequate protection of public health and safety and to promote the common defense and security and to protect the environment. This rule implements the agencys authority. The performance-based regimen provides the NRC with enhanced oversight of the competencies important to the protection of public health and safety. The performance-based framework, inspection and enforcement program, and design-specific review process provide reasonable assurance that protective actions can and will be taken in the event of an emergency. Regarding the plume exposure pathway EPZ, 10 CFR 50.33(g)(2) requires an applicant to perform an analysis to justify its proposed plume exposure pathway EPZ size for the facility. The NRC must approve the applicants proposal. Additionally, the NRC determines if the final safety report in the application contains the safety and risk analyses of dose consequence assessments of the spectrum of accidents necessary to meet EP requirements.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment D-1.16: One commenter expressed concern for the accuracy of plume exposure pathway EPZ models, arguing that they constitute educated guesses on the likelihood of future events and cannot consider the impacts of risk associated with cultural or religious values.

Additionally, the commenter said that models rely on assumptions and past data and cannot necessarily predict how people will react to an incident. The commenter suggested that the proposed plume exposure pathway EPZ approach could result in an EP response that is too narrow, focusing on modeled predictions rather than the area actually impacted by an incident.

The commenter urged the NRC to understand [their] concerns for the health and safety of [the]

Tribal community stating that both the licensee and NRC have a regulatory and fiduciary obligation to respond rapidly to a nuclear accident regardless of where the modeled plume exposure pathway EPZ is in comparison to the actual plume location. (SBT-7)

NRC Response: The NRC agrees, in part, with the comment. The process to determine the area of a plume exposure pathway EPZ includes a dose consequence analysis using information from a site-specific analysis to provide the necessary information on postulated accident likelihood, source terms, timing of accident sequences, and meteorology. The applicant is also required to use dose assessment modeling predictions that are compared to the 1-rem TEDE over 96-hour acceptance criterion. The size and area of an offsite plume exposure pathway EPZ also consider local emergency response needs and capabilities as they are affected by such conditions as demography, topography, access routes, and jurisdictional boundaries. Therefore, the NRC disagrees that this rule could result in a narrow EP focus. To the extent that an applicants proposed plume exposure pathway EPZ would encompass Tribal lands, the NRC would consult with the Tribe(s) during the licensing process to ensure consideration of Tribal concerns.

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Appendix A to the guidance document accompanying this rule, RG 1.242, provides guidance on the consequence analyses that support the plume exposure pathway EPZ size determination, including consideration of uncertainty. In general, when implementing risk-informed decisionmaking, the NRC expects that appropriate consideration of uncertainty will be given in the analyses used to support the decision and in the interpretation of the findings of those analyses. To support decisions on whether the plume exposure pathway EPZ meets the regulatory requirements, the supporting assessment should clearly explain how uncertainties in factors such as accident likelihood, source terms, and meteorology would affect the result.

Regarding the response to a nuclear accident, a licensee is required to implement prompt protective measures within the site boundary, and OROs are responsible for implementing protective measures beyond the site boundary. This response would be based on actual site-specific data for the accident where a defense-in-depth dose savings posture would be taken to account for deviations from model predictions.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment D-1.17: One commenter stated that current EP regulations and guidance direct licensees to use design-basis accidents (DBAs) and other severe accidents to determine plume exposure pathway EPZ size, but the lower postulated offsite releases of advanced reactors has created the possibility for adversary actions that could result in larger offsite releases than those modeled for DBAs. (CC-1)

NRC Response: The NRC disagrees with the comment. As part of the SAR, license applicants must include licensing-basis events in the required analysis to obtain the spectrum of accidents that are considered for the facilitys emergency response plans. Emergency preparedness requires the knowledge of the potential dose consequences, accident timing, and radiological release characteristics that are derived from such a spectrum of accidents, which includes severe accidents. The description of the postulated accident scenarios for the facility results from the risk assessment analysis in determining the range of events including DBAs and potential severe accidents that are beyond design basis.

In SECY-05-0010, Recommended Enhancements of Emergency Preparedness and Response at Nuclear Power Plants in Post-9/11 Environment, dated January 10, 2005 (ADAMS Accession No. ML042720354), the NRC staff affirmed that a terrorist act cannot affect core physics and cause melt sequences to occur faster or create a larger source term than those previously analyzed and identified enhancements to improve the implementation of emergency plans in response to security events, many of which were added to the NRCs regulations and guidance in 2011 (Enhancements to Emergency Preparedness Regulations; Final Rule (76 FR 72560, 72600; November 23, 2011)).

Accordingly, the NRC did not change the rule language in response to this comment.

Comment D-1.18: One commenter suggested that the NRC include a new provision requiring that licensees define a long-term relocation planning zone where the intermediate protective action guide (PAG) of 2 rem in the first year would be exceeded following an incident. The commenter stated that such incidents are likely to result in substantial offsite areas that would exceed the criterion even if they would not cause early-phase PAG to be exceeded off site. The commenter stated that licensees should work together with Federal, Tribal, State, and local authorities to develop contingency plans that would ensure long-term relocations of the public within relevant zones. (UCS-15) 56

NRC Response: The NRC disagrees with the comment. The NRC does not have the authority to make public protective action decisions or develop regulations for defining a long-term relocation planning zone in association with the U.S. Environmental Protection Agency (EPA)

PAG limits. State, local, and participating Tribal governments are responsible for ensuring timely and safe long-term relocations of the public within a plume exposure pathway EPZ that is beyond the licensees site boundary. These organizations have the authority to make decisions concerning public health and safety.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment D-1.19: One commenter explained that emergency planning and plume exposure pathway EPZs are an educational process that involves the public and Federal, State, and Tribal governments and helps build working relationships. The commenter stated that the proposed rule would curtail or eliminate this process and said that the needs of the reactor owners should not take [precedent] over the health and safety of local communities. (UW2-26)

NRC Response: The NRC disagrees with the comment. The final rule provides an alternative EP framework, including a scalable plume exposure pathway EPZ size. A scalable plume exposure pathway EPZ size will be a site-specific plume exposure pathway EPZ, which means the size of the plume exposure pathway EPZ will depend on factors unique to each SMR and ONT. Every applicant and licensee using 10 CFR 50.160 must provide a site-specific dose consequence analysis for NRC approval. Notwithstanding the size of the plume exposure pathway EPZ, the rule applies the same dose standard for predetermined, prompt protective actions to SMR or ONT facilities as is required of the current operating LLWR and non-power reactor facilities.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment D-1.20: One commenter suggested that the proposed plume exposure pathway EPZ requirements do not describe how conditions such as demography, topography, access routes, and jurisdictional boundaries will be assessed and considered, nor does it state how emergency response needs, capabilities, and conditions will be taken into consideration.

(UW2-59)

NRC Response: The NRC disagrees with the comment. The requirement cited in the comment is proposed 10 CFR 50.33(g)(2)(i)(B) and (ii), which would require the following for a plume exposure pathway EPZ that extends beyond the site boundary:

[The] exact configuration of the plume exposure pathway EPZ surrounding the facility shall be determined in relation to the local emergency response needs and capabilities as they are affected by such conditions as demography, topography, land characteristics, access routes, and jurisdictional boundaries.

The comment suggests that local emergency response needs and capabilities would be assessed separately from demography, topography, land characteristics, access routes, and jurisdictional boundaries. That interpretation is not the intent of this requirement. Instead, the final rule under 10 CFR 50.33(g)(2)(ii)(B) and (iii) requires the applicant or licensee to determine the configuration of the offsite plume exposure pathway EPZ by determining the impact of demography, topography, land characteristics, access routes, and jurisdictional boundaries on local emergency response needs and capabilities. For example, plume exposure pathway EPZ 57

boundaries that run through the middle of schools or hospitals, or that arbitrarily carve out small portions of governmental jurisdictions, should be avoided.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment D-1.21: A form letter campaign stated that emergency planning is the very last line of defense to protect public health and safety, and recommended, citing the National Academy of Sciences seventh review of the Biological Effects of Ionizing Radiation (BEIR VII), that there is no safe level of radiation exposure. (FL1-5)

NRC Response: The NRC disagrees with the comment. The NRC licenses and regulates the Nations civilian use of radioactive materials to provide reasonable assurance of adequate protection of public health and safety, to promote the common defense and security, and to protect the environment. Insofar as emergency planning and preparedness requirements are concerned, nuclear facility licenses are issued only when the NRC makes a finding that the state of EP provides reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency at the facility.

In SECY-05-0202, Staff Review of the National Academies Study of the Health Risks from Exposure to Low Levels of Ionizing Radiation (BEIR VII), dated October 29, 2005 (ADAMS Accession No. ML052640532), the NRC staff affirmed the following:

The major conclusion is that current scientific evidence is consistent with the hypothesis that there is a linear, no-threshold dose response relationship between exposure to ionizing radiation and the development of cancer in humans. This conclusion is consistent with the system of radiological protection that the NRC uses to develop its regulations. Therefore, the NRCs regulations continue to be adequately protective of public health and safety and the environment. Consequently, none of the findings in the BEIR VII report warrant initiating any immediate change to NRC regulations or Federal Guidance.

Accordingly, the NRC did not change the rule language in response to this comment.

Definitions Comment D-2.1: Several commenters requested that the NRC define the phrase, spectrum of credible accidents. Two commenters stated that a vague definition would allow individual licensees to determine what credible accidents are, and one commenter suggested that licensees may fudge their analyses to ensure the plume exposure pathway EPZ remains at or close to the site boundary. One commenter also suggested this would lead to additional work for the NRC staff in negotiating with applicants and analyzing the proposed plume exposure pathway EPZ size. Another commenter said that without a clear definition of the phrase, the whole basis of this proposed rule is weak and subject to interpretation and confusion in the future. One commenter wrote that the proposed approach for determining plume exposure pathway EPZ size is less prescriptive and technology-neutral but could benefit from a clearer description of what is considered a credible accident. One commenter suggested that the NRC develop a solid technical basissupported by robust independent peer review and extensive public engagement, before incorporating it into regulations. One commenter said that the definition should include numeric frequency thresholds and a listing of hazards to consider as well as guidance on which extreme external events are credible.

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One commenter wrote that the term is defined only in the proposed rules SOC, and the rule implies that this definition is similar to one defined in the current EP planning basis, but the definition in the SOC is not equivalent to the full spectrum of accidents referred to in NUREG-0396 or the spectrum of radiological incidents referred to in NUREG-0654, Revision 2, and therefore the comparison is not clear. Additionally, the commenter stated that the division between less severe and more severe BDBAs was based on a distinction between basemat melt-through accidents, which would result in relatively small atmospheric releases, and accidents resulting in containment failure or bypass causing relatively large atmospheric releases, but that it is not clear if this distinction would relate to non-LWRs.

(DBY-1, NSA-2, CRCPD-3, NNSA2-13, ANS-4, ANS-5, UCS-5, UCS-6, UCS-7, UCS-9)

NRC Response: The NRC agrees, in part, with the comments. The NRC disagrees with the comments that this rule should provide a regulatory definition of credible accident. The need to define credible accidents or the spectrum of credible accidents is out of the scope of this rule.

An applicant that complies with 10 CFR 50.160 must submit for NRC approval the analysis used to establish the size of the plume exposure pathway EPZ as part of the license application, which the NRC expects to be the typical form of a request to use the EP framework of 10 CFR 50.160. The determination of licensing-basis events, including whether accidents are credible for the facility, is a part of the safety analysis for the facility. As part of the SAR required for the facilitys license application, the applicant describes the postulated accident scenarios for the facility and also describes a summary of the probabilistic risk assessment (PRA) for a range of events, including potential severe accidents. The NRC reviews the applicants assessment of licensing-basis events, event likelihood, and public dose consequences as part of the agencys safety review of the license application. The NRCs determination of the acceptability of the applicants assessment supports the separate review of the applicants emergency plan.

The NRC agrees with comments that there is need for clarification of the plume exposure pathway EPZ size determination requirements and has revised the text in the final rule to provide more detail. In lieu of providing regulatory definitions of credible accident or spectrum of credible accidents, the NRC changed the rule text to clarify the requirement by listing the major considerations for the radiological consequence analysis to be used in determining the appropriate plume exposure pathway EPZ size for the facility. Specifically, the NRC replaced the phrase from the release of radioactive materials, resulting from a spectrum of credible accidents for the facility with the phrase from the release of radioactive materials from the facility considering accident likelihood and source term, timing of the accident sequence, and meteorology. To meet the requirements of this rule with respect to the analysis that aids in the determination of the plume exposure pathway EPZ, applicants may use the collection of accident scenarios and associated dose consequence assessment analyses as described in the SAR and information in the facility-specific PRA to provide the necessary information on accident likelihood, source terms, timing of accident sequences, and meteorology. Source terms are used to determine dose consequences. Timing of the accident sequence facilitates determining if prompt protective measures are warranted. Meteorology input is essential in determining the weather conditions that impact dose consequences due to atmospheric transport and dispersion of the radioactive plume.

In addition, the NRC added a second subpart to the regulatory text to clarify that the plume exposure pathway EPZ is also the area where predetermined, prompt protective measures are necessary. This rule provision adds a functional criterion to the EPZ to be consistent with the planning basis approach in NUREG-0396 and Federal guidance contained in EPA-400/R-17/001, PAG ManualProtective Action Guides and Planning Guidance for Radiological 59

Incidents (2017 PAG Manual). The NRC provides more detail on the basis for this provision in the final rule SOC.

In DG-1350, Appendices A and B, the NRC provided additional details on developing the consequence analysis that aids in the determination of the facilitys plume exposure pathway EPZ size. The NRC revised Appendix A to DG-1350 to add Section A-3.1, Event Selection, in RG 1.242, which discusses the applicants consideration of accident likelihood.

Accordingly, the NRC changed the rule and guidance in response to these comments.

Comment D-2.2: One commenter urged the NRC to require consideration of both credible and noncredible accidents in order to protect citizens from all potential hazards. The commenter stated that this is necessary because the NRC does not have design or operational histories for SMRs, non-LWRs, or other facilities to make reliable determinations that certain accidents are credible and others are not-credible. (UW2-29, UW2-53)

NRC Response: The NRC disagrees with the comments. The primary objective of EP and planning is to provide reasonable assurance that adequate protective measures can and will be implemented should there be an accidental release of radioactive materials from a licensed facility. Preparation, planning, and implementation of the necessary predetermined, prompt protective measures in the emergency plan require understanding of the radiological release characteristics, potential consequences, and timing of accident sequence derived from a spectrum of accidents, including BDBAs.

In the final rule, 10 CFR 50.33(g)(2) requires that the applicant must submit, as part of its license application, an analysis that considers accident likelihood and source term, timing of the accident sequence, and meteorology to establish the plume exposure pathway EPZ size. The applicant may use event likelihood to determine whether to include postulated accidents in the spectrum of accidents, which are subsequently evaluated by the NRC to support the applicants emergency plan submitted under 10 CFR 50.160. For example, facilities that use a maximum hypothetical accident should ensure that the estimated release is bounding for any event at the facility (see Chapter 13, Accident Analyses, in NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, issued February 1996 (ADAMS Accession No. ML042430055)).

The applicant can provide analytical justification to the NRC showing that accidents that are likely not credible can be excluded from the spectrum of accidents used for EP and planning. A technical basis for the screening of any identified release scenarios from quantitative consideration (for example, based on low likelihood or very long accident progression times) would need to be provided. The Commission explained the following in the Reactor Site Criteria Including Seismic and Earthquake Engineering Criteria for Nuclear Power Plants final rule (61 FR 65157, 65177; December 11, 1996):

It is worth noting that events having the very low likelihood of about 10-6 per reactor year or lower have been regarded in past licensing actions to be incredible, and as such, have not been required to be incorporated into the design basis of the plant.

However, the size of the plume exposure pathway EPZ does not preclude the applicant from expanding its emergency response planning to include scenarios that could be noncredible, if they ever were to happen.

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Accordingly, the NRC did not change the rule language in response to these comments.

Comment D-2.3: One commenter stated that the proposed rule should also consider BDBAs in order to prepare for a radiological accident outside the site boundary. The commenter suggested that the post-September 11, 2001, threat environment includes BDBA threats from cyberterrorism, nation-state threats, and home-grown terrorism, which should be accounted for in EP preparations. The commenter criticized the use of an all-hazards approach and wrote that the Federal Government cannot be expected to provide the necessary support in a timely fashion without understanding the needs of local jurisdictions. The other commenter requested that spectrum of credible accidents include a spectrum of sabotage attacks resulting in core melt and containment breach when determining EP requirements and the plume exposure pathway EPZ size. (FEMA-11, UCS-10)

NRC Response: The NRC agrees, in part, with the comments. As part of the SAR, license applicants must include licensing-basis events in the required analysis to obtain the spectrum of accidents that are considered for the facilitys emergency response plans. EP requires the knowledge of the potential dose consequences, accident timing, and radiological release characteristics that are derived from accidents evaluated as licensing basis events. The description of the postulated accident scenarios for the facility takes information from the risk assessment analysis in determining the range of events, including DBA and potential severe accidents that are beyond the design basis. See the NRC Response to Comment D-2.2 for more information on this topic. See the NRC Response to Comment D-1.17 regarding the consideration within the emergency planning basis of the potential consequences of terrorist events.

Accordingly, the NRC did not change the rule language in response to these comments.

Regulatory Criteria Comment D-3.1: Several commenters proposed an alternative graded approach for determining plume exposure pathway EPZ sizes. One commenter provided a 2020 report from Sandia National Laboratory that proposed five categories of plume exposure pathway EPZ sizes ranging from no plume exposure pathway EPZ if the projected dose is less than 1 rem at the site boundary to 10 miles if the projected dose is greater than or equal to 1 rem at 5 miles. One commenter cited previous variations in plume exposure pathway EPZ sizes for operating nuclear reactors to suggest that the NRC determine plume exposure pathway EPZ size by dividing the facilitys size (MW(t)) by 100. The commenter explained that NUREG-1935, State-of-the-Art Reactor Consequence Analyses Report, issued November 2012 (ADAMS Accession No. ML12332A057), demonstrates that a 10-mile plume exposure pathway EPZ is overly conservative; therefore, the approach would be sufficient and could be scaled if future consequence analyses were to justify changes. One commenter recommended that SMR and ONT facilities following a case-by-case determination process have a plume exposure pathway EPZ of no less than 10 miles and an IPZ no less than 50 miles. The commenter also recommended that the NRC require licensees and applicants to demonstrate capabilities in coordination with Tribes in relation to the size of the plume exposure pathway EPZ.

One commenter suggested that SMRs and non-LWRs with a thermal output of less than 20 MW should be eligible for a 2-mile plume exposure pathway EPZ. Additionally, a plume exposure pathway EPZ smaller than 2 miles should be available to facilities as long as FEMA, the NRC, and local authorities all agree that the alternate plume exposure pathway EPZ would provide an 61

adequate response in the case of an emergency. The commenter wrote that this methodology should include a plume exposure pathway EPZ sizing methodology that accounts for the possibility of accidents affecting more than one module, provides an appropriate IPZ, and maintains offsite drills every 2 years with the full suite of EP exercises every 8 years. One commenter recommended that the NRC consider developing alternative approaches to determining plume exposure pathway EPZ size than in the current proposal such as developing smaller plume and ingestion pathway EPZs applicable to all SMR and ONT facilities. The commenter wrote that this would acknowledge safety improvements in SMRs and provide a safety margin for unforeseen emergencies or issues, and this would allow the NRC to be more conservative due to a lack of operational history for SMR technologies and theoretical credible accident scenarios. (SBT-8, CLA-12, CRCPD-6, UCSJT-2, UWF1-1, UWJB-11)

NRC Response: The NRC agrees, in part, with the comments. The NRC agrees with the comments suggesting a scalable approach to sizing plume exposure pathway EPZs. The proposed rule described the history behind the development of the scalable approach, including the options that existed, were considered or used in the past, and are currently available for determining the size of the plume exposure pathway EPZ. The NRCs scalable approach to sizing a licensees plume exposure pathway EPZ is based on several factors as described in the NRC Response to Comment D-1.4. The NRC also agrees that the scalable approach should account for the possibility of accidents affecting more than one module, as described in the NRC Response to Comment D-1.7, and provide an appropriate IPZ. As described in the final rule SOC, the IPZ-related requirements of 10 CFR 50.160 would be appropriate for SMRs and ONTs.

The NRC disagrees that applicants and licensees should be required to demonstrate EP capabilities in coordination with Tribes to help determine the size of the plume exposure pathway EPZ. However, applicants and licensees are required to describe in their emergency plans the drill and exercise program that tests and implements major portions of planning, preparations, and the coordinated response by the onsite response organizations with the OROs within the plume exposure pathway EPZ, which would include Tribes that are identified in the emergency plan as having emergency response responsibilities. Identification of these Tribes would occur during the licensing of the facility, during which the NRC would follow its Tribal Protocol Manual and Tribal Policy Statement to communicate with potentially affected Tribes.

The NRC disagrees with using fixed-sized EPZs to accommodate technology-inclusive SMR and ONT designs, and that the rules scalability approach to plume exposure pathway EPZ sizing area is less conservative than what is currently required of LLWRs and non-power reactors. See the NRC Response to Comment D-1.8 for more information on this topic.

Additionally, 10 CFR 50.33(g)(2)(ii)(B) and (iii) require that the exact configuration of the plume exposure pathway EPZ be determined in relation to local emergency response needs and capabilities, as they are affected by such conditions as demography, topography, land characteristics, access routes, and jurisdictional boundaries.

The NRC disagrees that the scalable plume exposure pathway EPZ size or variable-distance approach in the rule is purely risk based. The rule requires applicants to perform an analysis for NRC approval of the scalable plume exposure pathway EPZ size for the SMR or ONT facility.

The analysis evaluates the expected public dose projected from the release of radioactive materials from the facility considering accident likelihood and other essential criteria, such as source term, timing of the accident sequence, and meteorology, against the criterion of 1-rem TEDE over 96 hours0.00111 days <br />0.0267 hours <br />1.587302e-4 weeks <br />3.6528e-5 months <br />. The consideration of event sequences and their likelihood arrives at the 62

spectrum of accidents needed for EP consideration using risk information accounting for all elements that define the plume exposure pathway EPZ size, instead of using risk-based values to determine such spectrum of accidents. Guidance is provided in RG 1.242 in support of risk-informed analyses for the radiological dose consequence assessment of the spectrum of accidents for plume exposure pathway EPZ size evaluation.

The NRC disagrees with plume exposure pathway EPZ scalability based solely on licensed reactor thermal power. The scalable approach in this rule to address plume exposure pathway EPZ size allows for the inclusion of new nuclear technologies. The design nature of some ONTs introduces source terms that are orders of magnitude smaller and with fuel enrichment potentially higher in comparison to current operating reactors, which would introduce different accounting of potential fission product releases impacting dose consequences as a function of different designs.

The NRC also disagrees that licensees should be required to maintain offsite drills every 2 years with the full suite of EP exercises every 8 years, as described in the NRC Response to Comment B-2.1.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment D-3.2: One commenter proposed establishing a 2-mile sheltering zone for SMRs and ONTs which would instruct the public to take shelter during an emergency prior to the release of any radioactive material. The commenter explained that this approach would provide defense-in-depth protection for unidentified accident sequences and would be an alternative to using PAGs to establish emergency planning requirements. The commenter also explained that an all sheltering area is not particularly onerous and would minimize the post-accident long-term sheltering problems that plagued Japan after Fukushima. Additionally, the commenter wrote that a 2-mile sheltering zone would bring the requirements for SMRs and ONTs in closer alignment with LLWRs. The commenter added that the 2-mile plume exposure pathway EPZ should be circular, rather than a keyhole design under current LLWR emergency plans, to account for shifts in wind conditions. The commenter suggested that the emergency response beyond 2 miles downwind should be to shelter, and if the wind direction changes, then the latest group of people downwind should be alerted to shelter. (MU-15, MU-16, MU-17)

NRC Response: The NRC disagrees with the comments. The plume exposure pathway EPZs are established for use in emergency planning to ensure that prompt and effective actions can be taken for public protection. The decisions for taking protective actions such as evacuation and sheltering beyond the site boundary during an event are made and implemented by OROs, which include government officials. The NRC does not have the authority to mandate the public to take protective actions such as sheltering or evacuation during an event. Therefore, the NRC cannot establish sheltering zones. However, the NRC requires its licensees to provide OROs with technical information and protective action recommendations for public protection.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment D-3.3: Two commenters recommended that the plume exposure pathway EPZ requirements should take meteorological conditions into consideration. One commenter suggested that the NRC allow normal diurnal variability in the wind direction during the 96-hour analysis periodto more accurately represent actual exposure risk to an individual at the site boundary, as the current methods assume a constant wind direction. The commenter explained that if these data are available, the NRC should develop compass point-based sector 63

exposure estimates and an appendix to DG-1350 that discusses the impact of meteorological variability. The other commenter stated that meteorological conditions could create significant impacts outside the site boundary, plume exposure pathway EPZs, and IPZs. The commenter also indicated that the proposed rule does not consider the impacts of emergency responses, such as evacuations, outside these zones. (NEIA-37, UW2-39)

NRC Response: The NRC agrees, in part, with the comments. Meteorological conditions must be considered in the dose consequence analysis for the determination of the plume exposure pathway EPZ size in the final rule. The proposed 10 CFR 50.33(g)(2) did not include meteorology among the factors to be considered in determining EPZ size because dose assessment analysis using software such as MELCOR Accident Consequence Code System (MACCS) accounts for meteorology when estimating the consequences of accidents. In addition, DG-1350 included meteorology among the inputs to a general methodology for determining plume exposure pathway EPZ size. However, in response to these and other comments, the NRC clarified 10 CFR 50.33(g)(2) in the final rule to state that the assessment of public dose resulting from the release of radioactive materials from the facility used to determine EPZ size must consider accident likelihood and source term, timing of the accident sequence, and meteorology.

Accordingly, the NRC revised the rule language in 10 CFR 50.33(g)(2) in response to these comments.

Comment D-3.4: One commenter stated that the primary factor that should be considered for plume exposure pathway EPZ size determination is the maximum potential source term. The commenter recommended that plume exposure pathway EPZ size and emergency response be based on potential public radiation exposures, and public exposure limits should be the same for both large reactors and SMRs. The commenter also said that other factors like isotopic composition of the release and environmental factors may impact plume exposure pathway EPZ size as well. (JH-1, JH-4)

NRC Response: The NRC agrees, in part, with the comments. The isotopic composition and magnitude of source terms are elements in the analysis for determinizing an SMR or ONT facilitys plume exposure pathway EPZ size. However, this analysis must also consider accident likelihood, timing of the accident sequence, meteorology, and the resulting spectrum of accidents. Additionally, the exact configuration of the plume exposure pathway EPZ is determined in relation to local emergency response needs and capabilities, as they are affected by such conditions as demography, topography, land characteristics, access routes, and jurisdictional boundaries. The objective of determining a facility-specific plume exposure pathway EPZ is to establish an EPZ appropriate for the facility so that the NRC has reasonable assurance that prompt protective measures can be taken to keep the public safe in the event of an accident. This objective serves a different purpose than the EPA PAGs, which are used in emergency response for recommending protective measures to provide public dose saving in the event of the release of radioactive materials from the facility.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment D-3.5: Two commenters asserted that the proposed rule inappropriately uses PAGs as the principal thresholds to determine if a plume exposure pathway EPZ is needed. One commenter stated that the PAGs are intended to help officials select protective actions under emergency conditions, not to define the need for offsite preparedness as they do not establish an acceptable level of risk for normal, non-emergency conditions, nor do they represent the 64

boundary between safe and unsafe conditions. One commenter also said that PAGs do not establish an acceptable level of risk for normal, nonemergency conditions, nor do they represent the boundary between safe and unsafe conditions. The commenter further asserted that a PAG is defined as the projected dose to an individual from a release of radioactive material at which a specific protective action to reduce or avoid that dose is recommended. (FEMA-9, UWF1-3, UWF2-1)

NRC Response: The NRC disagrees, in part, with the comments. The NRC agrees that the PAGs are intended to help officials select protective actions under emergency conditions; do not establish an acceptable level of risk for normal, nonemergency conditions, nor do they represent the boundary between safe and unsafe conditions; and are the approximate levels at which the associated protective actions are justified. The technical basis for the PAG values focuses on implementation of offsite protective actions to: (1) prevent acute effects, (2) balance protection with other important factors and ensure that actions result in more benefit than harm, and (3) reduce risk of chronic effects. (See 2017 PAG Manual, page 3.) The EPA PAG levels of 1 to 5 rem TEDE in the early phase of a radiological incident serve as the threshold for implementing protective actions such as evacuation or sheltering. Using the EPA PAGs to determine whether to take protective actions is the same for facilities complying with the EP framework in 10 CFR 50.160 as it is under the current EP framework for LLWRs.

However, the 2017 revision to the EPA PAG Manual states that the size of the EPZ is based on the maximum distance at which a PAG might be exceeded. (See 2017 PAG Manual, page 23.) The 2017 update refers to the 1992 EPA Manual of Protective Action Guides and Protective Actions for Nuclear Incidents (1992 PAG Manual), Appendices B, C, and E, as the bases of its risk discussion. (See EPA-400/R-92/001, May 1992.) The 1992 PAG Manual states, Since it will usually not be necessary to have offsite planning if PAGs cannot be exceeded offsite, EPZs need not be established for such cases. (See 1992 PAG Manual, page 2-3.) Thus, under the EPAs guidance, if an applicant or licensee can show that the maximum distance at which a PAG could be exceeded does not extend beyond a certain point (e.g., the site boundary, 2 miles from the site boundary), then no preplanned protective measures would be needed beyond that point. If the PAG used is the early-phase PAG of 1-5 rem TEDE (specifically 1 rem, which represents the lowest dose at which preplanned protective measures should be considered), then such a framework would be a conservative approach to emergency planning. This conservative approach is part of the framework of this final rule.

Under 10 CFR 50.33(g)(2), every applicant must provide as part of its application the analysis used to establish the size of the plume exposure pathway EPZ. The 1-rem TEDE over 96 hours0.00111 days <br />0.0267 hours <br />1.587302e-4 weeks <br />3.6528e-5 months <br /> dose criterion is one factor in determining the plume exposure pathway EPZ size. The final rule requires applicants to submit an analysis that evaluates expected public dose projected from the release of radioactive materials from the facility considering accident likelihood and other essential criteria, such as source term, timing of the accident sequence, and meteorology, against the criterion of 1-rem TEDE over 96 hours0.00111 days <br />0.0267 hours <br />1.587302e-4 weeks <br />3.6528e-5 months <br />. Additionally, the rule requires that the exact configuration of the offsite plume exposure pathway EPZ be determined in relation to local emergency response needs and capabilities, as they are affected by such conditions as demography, topography, land characteristics, access routes, and jurisdictional boundaries.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment D-3.6: Three commenters recommended that the NRC use a substantial reduction in early severe health effects for severe BDBAs as a criterion for establishing plume exposure 65

pathway EPZs. One commenter wrote that while it is unlikely that the 200-rem whole body dose requirement would be applied to SMRs and ONTs, its inclusion would support the basis that a reduced plume exposure pathway EPZ size can protect the public in similar ways to a 10-mile plume exposure pathway EPZ. Another commenter stated that NUREG-0396 also included a substantial reduction in early severe health effects for severe BDBA, and this criterion appears to form a primary basis for the 10-mile plume exposure pathway EPZ. The commenter also stated that if the credible accidents referred to in the proposed regulations include more than just credible scenarios, then this second criterion must be used. The commenter also requested that the NRC provide an explanation for not including the more severe Class 9 accident 200 rem whole body dose criteria in the methodology of Appendix A or add it to Appendix A. Another commenter added that the proposed rule does not appear to include this criterion for BDBAs. (DOE1-3, NSA-1, ANS-7, ANS-8)

NRC Response: The NRC agrees, in part, with the comments. The NRC agrees that the 200-rem whole body dose value in NUREG-0396 (Figure I-11) was provided among critical values for which emergency planners should be concerned and as the dose at which significant early injuries start to occur (NUREG-0396, page I-37). This criterion for the development of the 10-mile plume exposure pathway EPZ evaluated accidents with the potential for large releases to the atmosphere. The analysis in NUREG-0396 showed that the conditional probability of exceeding a dose of 200-rem whole body at distances exceeding 10 miles is very low and decreases rapidly. This high dose to distance was calculated based on an LLWR core melt accident with release to the atmosphere from failure of the containment, assuming that no protective actions were taken and assuming a straight-line plume trajectory from the source to approximately 10 miles downwind.

In contrast, this final rule is not designed for LLWRs. Each applicant complying with 10 CFR 50.160 will have to provide a site-specific analysis based on the design of its facility.

Unlike the evaluation in NUREG-0396, in which Class 9 accidents such as core melt were specifically defined for LWRs, the spectrum of accidents for a given applicant complying with 10 CFR 50.160 may not include a core melt, such as for a molten salt reactor, but would need to consider accidents specific to the facilitys technology and design. Some applicants with advanced light-water SMR designs could potentially include accident scenarios with large releases to the atmosphere similar to those in NUREG-0396. These applicants will use the final rules 1-rem TEDE over 96 hours0.00111 days <br />0.0267 hours <br />1.587302e-4 weeks <br />3.6528e-5 months <br /> criterion for design-specific accidents selected considering accident likelihood and source term, timing of the accident sequence, and meteorology, for determining the size of the EPZ.

Using a 200-rem whole body dose criterion would be contrary to the approach of this final rule, in which margins of performance exist to avert immediate safety concerns. For these reasons, an applicant that meets the plume exposure pathway EPZ criteria established by 10 CFR 50.33(g)(2) would certainly meet a 200-rem whole body dose criterion for prevention of early health effects with large margin, making it unnecessary to establish such a high dose criterion in this rule. Similarly, the use of the 200-rem whole body dose criterion need not be included in RG 1.242.

Accordingly, the NRC did not change the rule language or guidance in response to these comments.

Comment D-3.7: One commenter stated that the current plume exposure pathway EPZ rules are not technically sound and that the technical basis for the current 10-mile plume exposure pathway EPZ is dated, vague, and was demonstrated by Fukushima to be insufficiently 66

protective. The commenter recommended that the NRC determine plume exposure pathway EPZ size informed by mechanistic source term information, assuming that sufficient safety margin will be provided to fully account for the large uncertainties associated with such analyses. The commenter described how both the NRC and the National Atmospheric Release Advisory Center (NARAC) found that dose rates following the Fukushima event were high enough to exceed the EPA PAG well beyond 10 miles. The NARAC found that the thyroid dose to a 1-year-old child could have exceeded the 5 rem PAG for potassium iodide (KI) prophylaxis as far as 150 km (over 90 miles) from Fukushima. The commenter said that the NRC should not assume that a mechanistic source term evaluation, with full accounting for uncertainties to provide sufficient defense in depth, would result in smaller plume exposure pathway EPZs for SMRs and ONTs. (UCS-2, UCS-3)

NRC Response: The NRC disagrees with the comments. This rule includes alternativesto use either the current EP framework or the option of a risk-informed, performance-based, and technology-inclusive EP approach for SMR and ONT designs. The option for the new performance-based EP framework contains a shift from the current and traditional deterministic approach the NRC used in the EP framework for LLWRs, and both alternatives can accommodate a wide range of reactor and ONT designs. However, this final rule does not include within its scope emergency planning, preparation, or response for LLWRs, which, under this final rule, are reactors that are licensed to produce greater than 1,000 MW(t). Therefore, the comments associated with the criterion and manner of offsite response that were implemented during the Fukushima accident for those LLWRs are outside the scope of this rulemaking. The NRC addressed similar comments and requests in a petition for rulemaking designated as PRM-50-104, as described in the NRC Response to Comment D-1.10.

The NRC is not assuming that mechanistic source term evaluation, with full accounting for uncertainties and providing sufficient defense in depth, would result in smaller plume exposure pathway EPZs for SMRs and ONTs. A plume exposure pathway EPZ for an SMR or ONT could extend 10 miles from the facility, end at the site boundary, or be some other size. The regulatory criteria in 10 CFR 50.33(g)(2) require a license applicant for an SMR or ONT facility to submit an analysis for NRC approval for determining the plume exposure pathway EPZ size. This analysis, whether using a method that is mechanistic, deterministic, or a combination thereof, considers many factors, including the likelihood of accidents, public dose consequences, meteorology, and for offsite plume exposure pathway EPZs, demography, topography, land characteristics, access routes, and jurisdictional boundaries. The resultant plume exposure pathway EPZ and NRC-approved emergency plan provide the same level of EP for SMRs and ONTs as the current EP requirements for LLWRs.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment D-3.8: One commenter stated that NuScales research and NRC documents show that NUREG-0396 used exposure durations much shorter than 96 hours0.00111 days <br />0.0267 hours <br />1.587302e-4 weeks <br />3.6528e-5 months <br /> for each dose type.

The commenter recommended that the regulations clarify that exposure durations may not be consistent with NUREG-0396 and justify this difference. (NSA-6)

NRC Response: The NRC agrees, in part, with the comment. NUREG-0396 did consider exposure durations shorter than the 96 hours0.00111 days <br />0.0267 hours <br />1.587302e-4 weeks <br />3.6528e-5 months <br /> in the proposed rule, such as the 2-hour whole body dose for a loss-of-coolant accident (LOCA) in Figure I-8 on page I-32. However, Figure I-8 in the NUREG cannot be compared with 10 CFR 50.160 because the analysis behind Figure I-8 relies on several assumptions such as windspeed, distance, and atmospheric dispersion from 67 different nuclear power plants, whereas the analysis required by this final rule requires an 67

applicant to provide an analysis for only its facility. As stated in NUREG-0396, The results of the conservative licensing calculations for the DBA-LOCA vary from planttoplant because of plant design and variation in meteorology. Additionally, basing the plume exposure pathway EPZ size on an analysis that includes the lower end of the EPA early-phase PAG dose range of 1-rem TEDE, and a dose projection period of 96 hours0.00111 days <br />0.0267 hours <br />1.587302e-4 weeks <br />3.6528e-5 months <br /> from the time that the licensee would make the evaluation to support a protective action recommendation, provides assurance to OROs that the licensees determination of the EPZ size encompasses the area where, in the unlikely event of a release, OROs may need to use the early-phase PAG to make protective action decisions.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment D-3.9: One commenter suggested that the rule include the EPAs recommendation that KI be administered when the thyroid dose to a 1-year-old child or other vulnerable populations is projected to exceed 5 rem. The commenter suggested that this recommendation be included as a separate criterion for determining plume exposure pathway EPZ size. (UCS-11)

NRC Response: The NRC disagrees with the comment. Although KI is a possible protective measure in the event of a radiological emergency at a nuclear power plant, the dose criterion for administration is not a decisive factor in determining plume exposure pathway EPZ size. The NRC and EPA in NUREG-0396 concluded that thyroid dose, other organ dose, and external whole body dose showed similar characteristics when evaluated over the same distances. Furthermore, the EPA 2017 PAG Manual states that the former thyroid range of 5 to 25 rem is well covered by projections of whole body dose at 1 to 5 rem. Because the final rule already requires consideration of whole body dose, the consideration of thyroid, or any organ dose, would not add value to the determination of EPZ size. Additionally, use of the child thyroid PAG would be problematic as it does not pertain to the whole population. The EPA has guidance on the recommended KI dose for certain thyroid exposures. For adults over 40 years, the thyroid exposure is at least 500 rem, which is equivalent to 20-rem whole body. So, 1-rem whole body for EPZ size considerations bounds thyroid considerations for the population as a whole. Furthermore, the use of a thyroid PAG value in EPZ size determinations would be applicable only to accidents that have iodine-131 as a significant release characteristic.

In addition, the NRC does not require the use of KI. The use and dosage of KI by the public in the unlikely event of a severe nuclear reactor accident is the responsibility of OROs. Additional information on the use of KI and the U.S. Food and Drug Administration (FDA) guidelines, Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies, are available at the NRCs public Web site at https://www.nrc.gov/about-nrc/emerg-preparedness/about-emerg-preparedness/potassium-iodide-use.html.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment D-3.10: One commenter recommended that the NRC should specify in the rule, not just guidance documents, the parameters that must be used in conducting radiological assessments to ensure consistency, clarify, and sufficient level of conservatism with regard to source term composition, release, atmospheric dispersion, and deposition. Alternatively, the commenter stated that a safety factor could be applied to the criterion itself, such as a 0.1-rem value. (UCS-16) 68

NRC Response: The NRC disagrees with the comment. The final rule provides a technologyinclusive regulatory approach to EP that recognizes advances in new nuclear technologies that are embedded in design features, such as safety enhancements in evolutionary and passive systems available to respond to accidents. The range of these technological designs and features can vary widely in source term size and composition, fuel enrichment and type, chemical processes, and facility utilization and location. To allow for the variety of potential applicants, the performance-based requirements in 10 CFR 50.160 do not contain any technology-specific language, and applicants and licensees must demonstrate how the EP requirements are met based on their design- and site-specific considerations.

For determining EPZ size, 10 CFR 50.33(g)(2) requires applicants to include an analysis of a collection of accident scenarios and associated dose consequence assessments as described in the SAR to provide the necessary information on accident likelihood, source terms, timing of accident sequences and meteorology. Specifically, in the use of meteorological data, facility location and weather patterns must be considered separately for each facility, as is typically the case in codes such as MACCS, which uses those sitespecific source terms, along with site-specific weather, to model atmospheric transport and dispersion of released radionuclides, public protective actions, exposures, and health effects to compute offsite dose consequences.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment D-3.11: One commenter recommended that the NRC publish a description of the process to review source term determination and hazard analysis that includes technical experts outside the NRC to evaluate the technical basis for EPZ determination. The commenter stated that, given that no operational history exists for SMRs and ONTs, the NRC should promulgate stringent review practices for EPZ determination. (UCSJT-7)

NRC Response: The NRC disagrees with the comment. As stated in Appendix B to RG 1.242, each applicant should develop potential source terms for the accident analyses for its facility.

The NRC expects that the same methods that the applicant used in the safety analysis for the plant license application would also be used by the applicant in the dose analysis to support EPZ size determination. The NRC review of accident source terms is part of the safety review for the license application under either 10 CFR Part 50 or 10 CFR Part 52 and is not specific to the analyses supporting 10 CFR 50.160. Similarly, the hazard analysis required by 10 CFR 50.160(b)(2) considers some of the potential hazards required to be evaluated by the siting requirements in 10 CFR 100.21(e). As with an applicants source term determination, the NRC has the technical capability to assess these analyses. The NRCs NUREG-0800, Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants:

LWR Edition, is an example of the type of guidance that the NRC uses in reviewing license applications. NUREG-0800 provides guidance on the acceptance criteria, technical rationale, review procedures, and evaluation findings used in each review.

Additionally, as explained in the NRC Response to Comment A-2.2, under 10 CFR 50.43(e), the NRC requires the demonstration of the performance of safety features of new reactor designs before approving the designs.

Accordingly, the NRC did not change the rule language in response to this comment.

NRC Question: Is the proposed 10-millisievert (mSv) (1-rem) criterion appropriate? Are there particular factors and technical considerations that need to be included in an EPZ size analysis?

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Comment D-4.1: Several commenters expressed support for the 1-rem criterion. One commenter stated that it is as strict as the dose thresholds used to establish the 10-mile plume exposure pathway EPZ for large water-cooled nuclear power plants in NUREG-0396, as well as conservative and consistent with EPA guidance. Another commenter suggested that the NRC also consider a criterion that accounts for a substantial reduction in early severe health effects, highlighting the plume exposure pathway EPZ sizing methodology included in the Clinch River Nuclear Site ESP. (NNSA2-3, NEIA-13, HF-7)

NRC Response: The NRC agrees, in part, with the comments. The NRC disagrees with the direct comparison of the 1-rem TEDE over 96 hours0.00111 days <br />0.0267 hours <br />1.587302e-4 weeks <br />3.6528e-5 months <br /> criterion in the rule with the EPA PAG lower limit dose thresholds that were used in NUREG-0396 to establish the 10-mile plume exposure pathway EPZ for LLWRs. As noted in the NRC Responses to Comments D-3.4 and D-3.5, the EPA PAGs are used by OROs to implement offsite protective actions, whereas the 1-rem TEDE over 96 hours0.00111 days <br />0.0267 hours <br />1.587302e-4 weeks <br />3.6528e-5 months <br /> criterion in the final rule is only one of the parameters that must be used to determine the size of the plume exposure pathway EPZ.

The NRC also disagrees with considering an additional plume exposure pathway EPZ sizing criterion for this final rule because the plume exposure pathway EPZ sizing methodology described in the NRC-approved Clinch River Nuclear Site ESP is based on the current deterministic EP framework, which used NUREG-0396 considerations of conditional probability of acute dose exceeding a 200-rem whole body dose at distances outside of the 10-mile plume exposure pathway EPZ from more severe accident scenarios. The alternative EP framework in this final rule does not allow for a plume exposure pathway EPZ area boundary in exceedance of 1-rem TEDE over 96 hours0.00111 days <br />0.0267 hours <br />1.587302e-4 weeks <br />3.6528e-5 months <br /> from the release of radioactive materials from the facility considering accident likelihood and source term, timing of the accident sequence, and meteorology.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment D-4.2: Two commenters opposed the use of 10-mSv TEDE over 96 hours0.00111 days <br />0.0267 hours <br />1.587302e-4 weeks <br />3.6528e-5 months <br /> as the criterion to establish the plume exposure pathway EPZ size. The two commenters explained that the regulations place too much emphasis on one criterion as there are far too many other assumptions in calculations used to model offsite dose projections. One commenter stated that smaller release doses below the 1-rem PAG still threaten the safety and health of the public, and that 1-rem TEDE over a period of 96 hours0.00111 days <br />0.0267 hours <br />1.587302e-4 weeks <br />3.6528e-5 months <br /> does not adequately account for the unique aspects of a radiological incident. The commenter stated that the NRC must consider other factors including political considerations, environmental issues, and public trust. Additionally, variables such as the meteorological data, the dispersion model, the dosimetry model, and the source term selection, are left up to the licensees and applicants. The commenters said that while the NRC will review the licensees and applicants analyses, there remains subjectivity in the review. (NJDEP-3, NJDEP-23, CRCPD-4, CRCPD-23)

NRC Response: The NRC agrees, in part, with the comments. The NRC agrees that 1-rem TEDE over 96 hours0.00111 days <br />0.0267 hours <br />1.587302e-4 weeks <br />3.6528e-5 months <br /> should not be the sole requirement for plume exposure pathway EPZ size determinations. The NRC revised 10 CFR 50.33(g)(2) in the final rule to provide more details by replacing the phrase from the release of radioactive materials, resulting from a spectrum of credible accidents for the facility with the phrase from the release of radioactive materials from the facility considering accident likelihood and source term, timing of the accident sequence, and meteorology, and added a second subpart to the regulatory text to clarify that the function of the plume exposure pathway EPZ is to designate the area where predetermined, prompt 70

protective measures are necessary. Moreover, for an offsite plume exposure pathway EPZ, 10 CFR 50.33(g)(2)(ii)(B) and (iii) in the final rule require the following:

the exact configuration of the plume exposure pathway EPZ be determined in relation to local emergency response needs and capabilities, as they are affected by such conditions as demography, topography, land characteristics, access routes, and jurisdictional boundaries.

Accordingly, the NRC changed the rule language in 10 CFR 50.33(g)(2) in response to these comments.

Comment D-4.3: Two commenters suggested additional considerations to include in the determination of plume exposure pathway EPZ size. One commenter discussed consideration of accident scenario frequency, the appropriate cutoff criteria to remove extremely rare events and sequences from the sizing analysis, and the timing of a radiological release and exceedance of 1-rem TEDE over 96 hours0.00111 days <br />0.0267 hours <br />1.587302e-4 weeks <br />3.6528e-5 months <br />. The commenter explained that OROs would have already taken actions under all-hazards plans; therefore, releases occurring late in an accident sequence could be screened out. Another commenter asserted that using the 1-rem TEDE standard as the sole determination for plume exposure pathway EPZ does not adequately address anticipated ingestion pathway impacts and other offsite communication and coordination needed to address public concern with radiological releases. The commenter explained that emergency planning for all nuclear facilities should address offsite capabilities for critical specialized assets such as dose assessment and field survey and sampling to ensure maintenance of these specialized assets within the offsite jurisdictions. (NEIA-14, IDPH-4, IDPH-13, IDPH-14)

NRC Response: The NRC agrees, in part, with the comments. The NRC agrees that 1-rem TEDE over 96 hours0.00111 days <br />0.0267 hours <br />1.587302e-4 weeks <br />3.6528e-5 months <br /> should not be the sole requirement for plume exposure pathway EPZ size determinations. The NRC revised 10 CFR 50.33(g)(2) in the final rule to provide more details by replacing the phrase from the release of radioactive materials, resulting from a spectrum of credible accidents for the facility with the phrase from the release of radioactive materials from the facility considering accident likelihood and source term, timing of the accident sequence, and meteorology, and added a second subpart to the regulatory text to clarify that the function of the plume exposure pathway EPZ is to designate the area where predetermined, prompt protective measures are necessary. Moreover, for an offsite plume exposure pathway EPZ, 10 CFR 50.33(g)(2)(ii)(B) and (iii) in the final rule require the following:

the exact configuration of the plume exposure pathway EPZ be determined in relation to local emergency response needs and capabilities, as they are affected by such conditions as demography, topography, land characteristics, access routes, and jurisdictional boundaries.

The NRC disagrees that emergency planning for all nuclear facilities should address ingestion pathway impacts and offsite capabilities. As explained in the NRC Response to Comment B-7.2, the final rule provides for a scalable plume exposure pathway EPZ size. If the NRC finds acceptable a site-specific analysis supporting a site boundary plume exposure pathway EPZ, then the NRC will not require a formal offsite radiological emergency plan.

Communities can still develop and maintain radiological response capabilities without an NRC requirement for an offsite plume exposure pathway EPZ. Furthermore, for the reasons explained in the proposed rule SOC and the NRC Responses to Comments E-1.1 and E-2.1, the NRC is not requiring a formal ingestion pathway EPZ in the final rule.

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The NRC disagrees with adding cutoff criteria to identify and remove extremely rare events and sequences from the EPZ sizing determination analysis. The information needed to support the EPZ sizing determination analysis, such as accident likelihood, source terms, timing of accident sequences and meteorology, is found in the safety analysis for the plant license application, which contains the applicable accident scenarios and associated dose consequence assessment analyses. As explained in the NRC Response to Comment D-3.11, the NRC expects that the same methods that the applicant used in its safety analysis for the license application would also be used by the applicant in the dose consequence analysis to support EPZ size determination. Thus, requirements on how applicants perform this analysis would be outside the scope of this rulemaking.

Nevertheless, the NRC revised the draft guidance supporting this rule to provide additional details on developing the consequence analysis that aids in the determination of the facilitys plume exposure pathway EPZ size. The NRC revised Appendix A to DG-1350 to add Section A-3.1, Event Selection, in RG 1.242 where consideration of accident likelihood is discussed to arrive at the spectrum of accidents used in 10 CFR 50.160. Additionally, applicants could use RG 1.233, Guidance for a Technology-Inclusive, Risk-Informed, and Performance-Based Methodology To Inform the Licensing Basis and Content of Applications for Licenses, Certifications, and Approvals for Non-Light-Water Reactors, issued June 2020 (ADAMS Accession No. ML20091L698). This RG endorses the methods in Nuclear Energy Institute (NEI) 18-04, Revision 1, Risk-Informed Performance-Based Technology Inclusive Guidance for Non-Light Water Reactor Licensing Basis Development, issued August 2019 (ADAMS Accession No. ML19241A472), which contains threshold values for event selection that could be used in determining the spectrum of accidents used for dose assessment.

Accordingly, the NRC changed the rule language in 10 CFR 50.33(g)(2) and the guidance in response to these comments.

NRC Question: If the analysis demonstrates that the EPZ is within the facilitys site boundary, would the need for a dedicated, Federal-mandated offsite radiological EP program exist?

Comment D-5.1: Several commenters stated that facilities with a site boundary plume exposure pathway EPZ should have an offsite EP program. Three commenters stated that using the 1-rem TEDE dose criterion is too narrow, and offsite emergency planning should be required. One commenter said that the need for offsite EP is demonstrated through the need for ingestion pathway planning even when the 10-mSv (1rem) TEDE over 96 hours0.00111 days <br />0.0267 hours <br />1.587302e-4 weeks <br />3.6528e-5 months <br /> criterion does not require a plume exposure pathway EPZ. (NJDEP-24, CRCPD-24, IDPH-15)

NRC Response: The NRC agrees, in part, with the comments. As explained in the NRC Response to Comment D-4.2, the NRC changed the 1-rem TEDE dose criterion for determining the size of plume exposure pathway EPZs under 10 CFR 50.160 in the final rule. However, the NRC disagrees that it must require an offsite radiological EP program for facilities with a site boundary plume exposure pathway EPZ. As explained in the NRC Response to Comment B-7.2, the final rule provides for a scalable plume exposure pathway EPZ size. If the NRC finds acceptable a site-specific analysis supporting a site boundary plume exposure pathway EPZ, then, using a risk-informed decisionmaking process, the NRC will not require a formal offsite radiological emergency plan. Communities can still develop and maintain emergency response capabilities, including radiological emergency response, without an NRC requirement for an offsite plume exposure pathway EPZ. Regarding ingestion pathway planning, for the reasons 72

explained in the NRC Responses to Comments E-1.1 and E-2.1, the NRC is not requiring formal ingestion pathway EPZ planning in the final rule.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment D-5.2: One commenter asserted that there is no technical basis for requiring an offsite radiological EP program if the plume exposure pathway EPZ is within the facilitys site boundary. The commenter explained that the plume exposure pathway EPZ sizing requirements reflect the NRCs Principles of Good Regulation in that they are based on the best available knowledge from research and operational experience. Further, the commenter stated that offsite planning will be accomplished through communication and cooperation between State and local governments and the facility owner, similar to planning for other industrial facilities using guidance developed by the U.S. Department of Homeland Security.

(NEIA-16)

NRC Response: The NRC agrees, in part, with the comment. As explained in the NRC Response to Comment B-7.2, the final rule provides for a risk-informed decisionmaking process that produces a scalable plume exposure pathway EPZ size. If the NRC finds acceptable a site-specific analysis supporting a site boundary plume exposure pathway EPZ, then the NRC will not require a formal offsite radiological emergency plan. However, the NRC is not requiring facility licensees to be involved in offsite planning in these situations and cannot agree with the statement in the comment that offsite planning will be accomplished through communication and cooperation between State and local governments and the facility owner.

Accordingly, the NRC did not change the rule language in response to this comment.

Risk-Informed Approach Comment D-6.1: Several commenters, including a form letter campaign, suggested that plume exposure pathway EPZ size considerations should not be based solely on risk probabilities and offered additional factors to consider. One commenter highlighted that NUREG-0396, developed by the NRC and EPA, indicates that radiological emergency planning should not be based on risk probabilities but perceptions of what could be done to protect public health and safety, and indicates that plume exposure pathway EPZ requirements should consider BDBAs and provide defense-in-depth protection. The commenter stated that the NRC and EPA recognized that, though extreme accidents were unlikely, nuclear accidents are unique, and the consequences require specialized planning considerations. The commenter stated that these considerations are ignored in the proposed rule, and instead, plume exposure pathway EPZ sizing is purely a quantitative, risk-based consideration. One commenter stated that the proposed approach could open the door to reactors of any size reducing emergency planning requirements based on a calculation of risk.

Another commenter said that to manage the risk from developing threats to commercial nuclear power plants, the proposed rule must consider the full threat spectrum and potential BDBAs.

One commenter said that the plume exposure pathway EPZ size should consider defense in depth, human judgment, and certain communities that need to be protected.

One commenter stated that the NRC failed to ensure that the proposed regulations do not cause disproportionate impacts on communities of color or economically disadvantaged groups as it exempts applicants who are able to meet the proposed criteria from offsite emergency planning, and this puts the burden of protecting the public from potential accidents on the State, 73

Tribal, and local governments. Additionally, the commenter said that the single dose-based criterion does not take into account disparities in health care that could make a significant difference for cancer survival rates and a range of other conditions resulting from cancer morbidity.

A form letter campaign highlighted that while SMRs are smaller than traditional LLWRs, most facilities are expected to group multiple units together. The commenter wrote that the Fukushima incident demonstrated that a single event can cause multiple reactors to fail at the same time. As a result, the commenter stated that it is arbitrary and capricious for NRC to assume that licensee applicantsshould be able to exempt themselves from emergency planning based solely on risk calculations. (SL2-6, FEMA-3, UCS-12, UCS-13, UW2-32, UW2-34, UWJB-2, UWJB-3, UWJB-4, FL1-8)

NRC Response: The NRC agrees, in part, with the comments. The NRC agrees that 1-rem TEDE over 96 hours0.00111 days <br />0.0267 hours <br />1.587302e-4 weeks <br />3.6528e-5 months <br /> should not be the sole requirement for plume exposure pathway EPZ size determination. The NRC revised 10 CFR 50.33(g)(2) in the final rule to provide more details by replacing the phrase from the release of radioactive materials, resulting from a spectrum of credible accidents for the facility with the phrase from the release of radioactive materials from the facility considering accident likelihood and source term, timing of the accident sequence, and meteorology, and added a second subpart to the regulatory text to clarify that the function of the plume exposure pathway EPZ is to designate the area where predetermined, prompt protective measures are necessary. Moreover, for an offsite plume exposure pathway EPZ, 10 CFR 50.33(g)(2)(ii)(B) and (iii) in the final rule require the following:

the exact configuration of the plume exposure pathway EPZ be determined in relation to local emergency response needs and capabilities, as they are affected by such conditions as demography, topography, land characteristics, access routes, and jurisdictional boundaries.

Thus, the sizing of plume exposure pathway EPZs is risk informed and consequence oriented.

See also the NRC Responses to Comments D-1.3 and D-3.1 for more information on this topic.

In DG-1350, Appendices A and B, the NRC provided draft guidance on developing the consequence analysis that aids in the determination of the facilitys plume exposure pathway EPZ size. The NRC revised Appendix A to DG-1350 to add Section A-3.1, Event Selection, in RG 1.242 where consideration of accident likelihood is discussed to arrive at the spectrum of accidents used in 10 CFR 50.160. Additionally, applicants could use RG 1.233, which endorses the methods in NEI 18-04, Revision 1, which contains threshold values for event selection that could be used in determining the spectrum of accidents used for dose assessment.

The comment concerning environmental justice is correct in that if the NRC does not require offsite radiological EP, then protecting the public from potential accidents is a responsibility shared by all OROs. However, protecting the public from any natural or manmade hazard is a responsibility shared among many OROs and potentially all of them depending on the hazard.

Further, the comment assumes that an accident would occur at the facility and individuals nearby would develop cancer as a result of a radiological dose from the accident. The NRC does not assume that an offsite radiological release will occur and nearby individuals will develop cancer. That approach would be risk-based regulation, and the NRC is a risk-informed regulator. The NRC addresses environmental justice issues through the NEPA process during licensing reviews. If an applicant decides to comply with the requirements of this final rule, then 74

the NRC would consider the environmental justice impacts of constructing and operating the proposed facility on nearby communities during the NEPA review.

Regarding the comments concerning multiple reactors at a single site, in addition to the response above, see the NRC Response to Comment C-1.4.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment D-6.2: Several commenters expressed support for the proposed rules plume exposure pathway EPZ sizing methodology, writing that it is appropriately risk based. Two commenters stated that the proposed rule continues to provide defense-in-depth protection and would allow for the same level of protection as current standards. One commenter noted that facilities will be able to reduce their plume exposure pathway EPZs below the default of 10 and 50 miles only by meeting the strict standards of the rule and will be required to increase the level of protection afforded by all layers of DID [defense in depth], specifically accident prevention and mitigation measures, thereby preventing significant radiological releases from occurring. One commenter expressed support for the proposed rule and said that the regulations appropriately organize regulatory requirements around metrics of radiological risk rather than generic compliance. The commenter further stated that the proposed regulations justly focus on the objective of dose reduction rather than targeting the existing 10-mile plume exposure pathway EPZ regulation. One commenter supported the proposed approach, arguing that the two accidents associated with water moderated reactors have had virtually no impacts on plume exposure pathway EPZs. (GHX-3, DOE1-4, NR-4, HF-1, NNSA2-4)

NRC Response: The NRC agrees, in part, with the comments. The NRC considers emergency planning and response as the facilitys last layer of defense in depth. In this final rule, the NRC recognizes advances in design and technological advancements embedded in design features and credits safety enhancements in evolutionary and passive systems. These newer, safer, and more advanced reactor designs will support the same level of EP as the current fleet of operating reactors through a risk-informed and consequence-based EP approach. However, the NRC does not consider this rule to be risk based, as explained in the NRC Responses to Comments D-1.3 and D-3.1.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment D-6.3: Three commenters stated that the proposed rule does not account for the simultaneous failure of multiple SMR units at the same facility. One commenter noted that SMR designs show that numerous SMR units would share the same control room at a single site.

The commenter expressed concern that one control room for multiple sites brings forth the possibility of common mode failure accidents involving multiple units. The commenter wrote that such an accident would be characterized by large radiological source term releases to the environment. The commenter further stated that the proposed rule creates a critical failing in preparedness by eliminating offsite EP and therefore essentially removing FEMA from the licensing process. One commenter wrote that the proposed plume exposure pathway EPZ sizing methodology evaluates each reactor in isolation and ignores the possibility of a disaster that can simultaneously threaten multiple reactors at a site, such as the Fukushima disaster.

(BN-5, UW2-35, UWJB-8)

NRC Response: The NRC disagrees with the comments. FEMA will still make reasonable assurance findings and determinations on offsite radiological emergency response plans when 75

the plume exposure pathway EPZ extends beyond the site boundary. Regarding the comments concerning multiple reactors at a single site, see the NRC Response to Comment C-1.4.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment D-6.4: One commenter noted that LWRs, SMRs, and ONTs present small risk profiles should a core melt sequence occur. The commenter explained that these risk profiles are achieved by designs within the nuclear facilities themselves and through natural forces acting within the containment building. The commenter suggested that naturally occurring, consequence-reducing actions that take place outside the facility, such as wind shifts and human biology, lessen risk and that it would require large amounts of radiological exposure to cause an early health effect. Therefore, emergency plans should be simple and emphasize sheltering in place to avoid over-evacuation. The commenter also discussed potential accidents known as unknown unknowns and explained that SMRs and ONTs are better designed to handle these rare emergencies than LWRs. (MU-3, MU-4)

NRC Response: The NRC agrees, in part, with the comments. The rule credits several concepts that could reflect the lower potential radiological risk hazards associated with SMR and ONT facilities such as advances in design and technology advancements embedded in design features, safety enhancements in evolutionary and passive systems, and the potential benefits of smaller sized reactors and non-LWRs associated with postulated accidents, including slower transient response times and relatively small and slow release of fission products. In the license application, the applicant is required by the NRC to provide site-specific information sufficient to support NRC safety findings for those design features, which includes doseconsequence assessment analyses informing the SAR and facility-specific risk assessment providing the necessary information on accident likelihood from a spectrum of accidents that inform emergency planning and response.

However, the NRC does not require emergency plans to emphasize sheltering in place. OROs make the decision to implement public protective measures such as sheltering in place and evacuating. In the final rule, the NRC requires emergency plans to describe the protective measures to be taken within the EPZ to protect the health and safety of the public in the event of an emergency but does not mandate that certain protective actions be recommended or taken.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment D-6.5: One commenter explained that the use of PRA to determine the likelihood of accident scenarios has improved since the development of NUREG-0396. The commenter said that the NRCs proposed approach is more conservative than requiring a 10-mile plume exposure pathway EPZ for facilities of all sizes and that DG-1350 requires sufficient emergency planning and hazard identification to mitigate the impacts of these identified multimodule hazards. The commenter outlined what the PRA should consider, such as internal and external hazards, all modes of operation, and all significant radionuclide sources, and include event sequences involving single or multiple modules [and] units. (NNSA2-6, NNSA2-7)

NRC Response: The NRC agrees, in part, with the comments. Significant design-specific and plant-specific PRA information has been developed since NUREG-0396 was published in 1978.

The Commissions PRA Policy Statement (60 FR 42622; August 16, 1995) states the following:

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The Commission believes that the use of PRA technology in NRC regulatory activities should be increased to the extent supported by the state-of-the-art in PRA methods and data and in a manner that complements the NRCs deterministic approach and supports the NRCs deterministic approach.

Although PRA is not required for obtaining risk insights, the final rule allows for applicants to use PRA as one option to support a risk-informed approach for the development of the source terms event analysis that would determine the spectrum of accidents used for SMR and ONT licensing. For example, RG 1.233 endorses NEI 18-04, Revision 1, which provides guidance to applicants for using PRA insights as an advanced licensing tool for providing information sufficient to support NRC safety findings for advanced reactor designs. Also, even though not yet endorsed by the NRC, American Society of Mechanical Engineers/American Nuclear Society RA-S-1.4-2021, Probabilistic Risk Assessment Standard for Advanced Non-Light Water Reactor Nuclear Power Plants, dated February 8, 2021, could be used to inform the applicants information, as applicable. The NRC also provides guidance in RG 1.242 on the use of PRA to meet the requirements of 10 CFR 50.160.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment D-6.6: One commenter disagreed with the argument that the proposed rule does not account for the possibility of multiple SMR accidents at a site. The commenter said that the licensing process for SMRs has proven them to be walk-away safe. The commenter further asserted that the Fukushima event involved the destruction of three reactors, but there was almost no release of radiation from the reactors themselves as most of the radiation came from spent fuel cooling vessels. The commenter noted that modern SMRs will not have such a fuel feature and instead will be manufactured with fuel inside. (GHX-5)

NRC Response: The NRC agrees, in part, with the comment. The final rule accounts for multiple reactor units at a single site, as explained in the NRC Response to Comment C-1.4.

However, the licensing process does not show that SMRs are inherently walk-away safe from a foreseeable accident. Each applicant must provide a safety analysis for its facility, and the NRC must approve it before the agency will issue a license.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment D-6.7: One commenter said that emergency planning for nuclear power plants is focused on preventing early health effects of radiation exposure, but the long-term health effects of exposure can be reduced by actions taken to prevent early health effects. The commenter defined early health effects as any consequences of radiation that manifest themselves within 60 days of exposure and long-term health effects as consequences that may not be apparent until years after exposure. The commenter stated that various studies of nuclear accidents have shown that the range of early fatality risk is between 0 and 1 mile from point of release.

The commenter further wrote that the range for radiation sickness is 0 to 2 miles from the point of release. The commenter said that knowledge of these ranges is helpful in emergency planning for SMRs and ONTs. (MU-7)

NRC Response: The NRC agrees, in part, with the comment. The final rule requirements for SMRs and ONTs are commensurate with the potential radiological dose consequences to public health and safety posed by these facilities. The NRC identified emergency response functions that licensees must implement through emergency plans, thereby allowing for the licensee and OROs to take adequate protective measures resulting in dose savings and reduction in early 77

health effects to the public. However, the NRC does not necessarily agree with or has not confirmed some of the statements in the comment, such as defining early health effects from radiation exposure as any consequences of radiation that manifest themselves within 60 days of exposure and that the range for radiation sickness is 0 to 2 miles from the point of release.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment D-6.8: One commenter wrote that some commenters have requested that the proposed rule require consequence analysis for low-probability events, security considerations, and other beyond-design-basis events to inform the final plume exposure pathway EPZ determination, but this is not a current requirement of the existing EP framework. The commenter stated that the proposed rule would require SMRs and ONTs to develop a documented evaluation of the consequences of low-probability and other beyond-design-basis events. The commenter noted that security considerations are addressed under different rules for both the existing and proposed EP approaches. The commenter further asserted that under the new rule, these documented evaluations and considerations would inform any changes in the plume exposure pathway EPZ size. (NNSA2-11)

NRC Response: The NRC agrees, in part, with the comment. In 10 CFR 50.33(g)(2), the applicant is required to provide the technical basis for its proposed plume exposure pathway EPZ size, which includes an analysis of the facility-specific assessment of the spectrum of accidents in association with dose consequences to individuals and the public. The spectrum of accidents includes dose consequence assessments of a wide range of DBAs and BDBAs necessary to meet the facilitys EP and response plan requirements. The NRC disagrees that security considerations would inform changes in the EPZ size because, as the comment notes, security considerations are outside the scope of this rulemaking. Changes to plume exposure pathway EPZ size could be made under the applicable provisions of 10 CFR 50.54(q).

Accordingly, the NRC did not change the rule language in response to this comment.

Comment D-6.9: One commenter stated that plume exposure pathway EPZ requirements do not consider an accident scenario consisting of long-term storage and transportation of irradiated fuel at the reactor site. The commenter noted that within such a scenario, the NRC does not consider the risks and hazards of loading thin-walled canisters containing irradiated fuel into dry casks, long-term storage of canisters that cannot be monitored or repaired, and transporting canisters and casks on site and off site. (UW2-54)

NRC Response: The NRC disagrees with the comment. Irradiated fuel stored on the site of a nuclear power reactor is stored in spent fuel pools or independent spent fuel storage installations (ISFSIs). An ISFSI is licensed under 10 CFR Part 72, Licensing requirements for the independent storage of spent nuclear fuel, high-level radioactive waste, and reactor-related greater than Class C waste. A 10 CFR Part 72 specific license ISFSI must comply with the EP requirements in 10 CFR 72.32. Most power reactor licensees have 10 CFR Part 72 general licenses for their ISFSIs. For these ISFSIs, 10 CFR 72.32(c) provides that the emergency plan required by 10 CFR 50.47 satisfies the EP requirements of 10 CFR 72.32. This same policy applies to an ISFSI on the site of a power reactor whose licensee is complying with 10 CFR 50.160. In the final rule, the NRC made a conforming change to revise 10 CFR 72.32(c) to clarify that the emergency plan required by 10 CFR 50.160 also satisfies the EP requirements of 10 CFR 72.32. Additionally, 10 CFR 50.160 requires an analysis for determining the spectrum of accidents to be used in support of the facilitys emergency plan. In that analysis, the applicant or licensee must include considerations of all radionuclide sources, 78

including an ISFSI if one is or will be located on the site. Although loading, storing, and transporting spent fuel canisters and casks on site and off site are not within the scope of this rule, additional information on spent fuel storage and transportation may be found at https://www.nrc.gov/waste/spent-fuel-storage.html and https://www.nrc.gov/waste/spent-fuel-transp.html.

Accordingly, the NRC did not change the rule language in response to this comment but included a conforming change to 10 CFR 72.32(c) in the final rule.

Comment D-6.10: One commenter discussed the general concern regarding the need for proposed regulations to address hazard analysis and emergency planning for mixed-mode or multimodule advanced reactor facilities. The commenter said that, similar to the current EP framework, the multimodule events are addressed in regulatory guidance. The commenter said that DG-1350 requires identification and characterization of specific hazards posed by multimodule units, as well as evaluation of impacts and descriptions of the emergency planning or response functions in place to mitigate impacts of identified hazards. The commenter also said that other aspects of the NRC regulatory framework ensure that multimodules and other types of facilities will not result in undue risk. (NNSA2-12)

NRC Response: The NRC agrees, in part, with the comment. The proposed rule included regulations to address hazard analysis and emergency planning for mixed-mode or multimodule advanced reactor facilities. The NRC carried these regulations forward into the final rule. In the final rule, 10 CFR 50.160(b)(2) requires a licensee to do the following:

conduct a hazard analysis of any contiguous facility, such as industrial, military, and transportation facilities, and include any credible hazard into the licensees emergency preparedness program that would adversely impact the implementation of emergency plans.

Furthermore, each module source term must be part of the aggregate considered in the dose consequence analysis for determining the spectrum of accidents for the entire facility as part of the EPZ sizing determination. The NRC agrees that RG 1.242 provides guidance to applicants and licensees on how to comply with these requirements.

Accordingly, the NRC did not change the rule language in response to this comment.

E. Requirement To Describe Ingestion Response Planning10 CFR 50.160(b)(4)

General Comments on the Requirement To Describe Ingestion Response Planning Comment E-1.1: Several commenters expressed concern over what they described as an elimination of ingestion planning requirements. Some commenters stated that the proposed rules IPZ requirements will not protect the public from ingestion of water and food products contaminated by radioactive isotopes. Some commenters suggested that IPZs are essential for a timely and effective emergency response. One commenter requested stricter IPZ requirements, stating that the COVID-19 pandemic is an example of ineffective Federal response to an emergency and that such a situation could easily happen during a nuclear incident. The commenter suggested that to avoid a similar inefficient emergency response, the NRC must codify all EP and response strategies and reexamine planning, response, quarantines, and embargoes. If not, the NRC will be required to activate its incident response program. Finally, one commenter wrote that the lack of drill and exercise requirements for 79

facilities with a site boundary plume exposure pathway EPZ contradicts the need to demonstrate public protective actions related to ingestion pathway exposures. (SBT-9, BN-6, IDPH-8, IDPH-16, UCS-14, UW2-36)

NRC Response: The NRC disagrees with the comments. Ingestion response planning focuses planning efforts on the identification of major exposure pathways for ingestion of contaminated food and water resulting from an accident involving the release of radioactive material from a nuclear power plant. These response activities include the sampling, assessing, and imposing of a quarantine or embargo of food and water to prevent contaminated food and water from entering the ingestion pathway. These response activities are implemented in the intermediate or later stage response to an accident involving the release of radioactive material. The duration of any exposure to contaminated food or water could range from weeks to months and represents a long-term response need. Federal intermediate and later stage emergency response activities are described in the NRIA to the Response and Recovery FIOP in the NRF.

See the NRC Responses to Comments B-1.6, B-4.8, and B-7.2 for more information concerning the planned Federal intermediate and later stage emergency response activities.

In addition to the Federal planning and resources that would be called on to respond to a radiological emergency, this final rule requires applicants and licensees complying with 10 CFR 50.160 to describe in their emergency plans the capabilities to prevent contaminated food and water from entering the ingestion pathway. The capabilities described in the emergency plan need to address major exposure pathways associated with the ingestion of contaminated food and water. Even in cases where the facilitys plume exposure pathway EPZ is bounded by the site boundary, the applicant or licensee must reference capabilities of Federal, State, and local authorities. These requirements provide the same capabilities available to identify and interdict contaminated food and water in the event of a radiological emergency as required under the EP regulations in Appendix E to 10 CFR Part 50 for currently operating nuclear power reactor licensees.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment E-1.2: One commenter stated that the proposed rule gives no consideration to Tribal communities and suggested that the NRC provide ongoing outreach and training activities to Tribes related to the ingestion pathway planning and response. The commenter stated that natural resources are vital to the subsistence lifestyle of Tribal communities and that contamination of said natural resources can have a disproportionate impact on Tribes. The commenter asserted that natural resource access restrictions due to contamination can have a significant impact on traditional ceremonies and religious practices. The commenter further wrote that the NRC must add a provision to the rule requiring case-by-case evaluations of projects to fully assess corresponding impacts to Tribes use of lands, water, wildlife, plants, and other important resources used for cultural and ceremonial purposes specified in treaty rights that are protected under the Fort Bridger Treaty of 1868, which must be included in IPZ evaluation criteria.

Additionally, the commenter recommended that the NRC expand the definition of public outreach in the proposed rule to include Tribal outreach which can include the consumption and/or limited access to wildlife, fish, migratory birds, medicinal plants or other natural and cultural resources that are often consumed in Native American diets or used in religious activities. (SBT-10, SBT-19) 80

NRC Response: The NRC disagrees with the comments. The NRC, not an applicant, is required to comply with treaties between the U.S. Government and Tribes. Also, the NRC is not requiring an applicant complying with 10 CFR 50.160 to have an IPZ. Therefore, the NRC did not revise the rule to require applicants to include, in their ingestion response planning, assessments of impacts to Tribes use of land, water, and other resources used for cultural and ceremonial purposes specified in treaty rights. The potential impacts to Tribes use of land, water, and other resources used for cultural and ceremonial purposes specified in treaty rights will be analyzed by the NRC in site-specific licensing actions and in government-to-government consultation between the Tribes and the NRC.

Nevertheless, the NRCs guidance for reviewing applications that would comply with 10 CFR 50.160 will direct the NRC staff to consider, consistent with the Tribal Policy Statement, whether the action may have a substantial direct effect on one or more Tribes. The NRC also revised DG-1350 to inform potential applicants that they may need to reach out to States or the NRC or another Federal agency, as applicable, to coordinate with Tribes to obtain information to meet the NRCs application requirements for emergency planning.

The NRCs NUREG-1555, Standard Review Plans for Environmental Reviews for Nuclear Power Plants: Environmental Standard Review Plan, issued June 2013 (ADAMS Accession No. ML13106A246), and NUREG-1748, Environmental Review Guidance for Licensing Actions Associated with NMSS Programs, issued August 2003 (ADAMS Accession No. ML032450279),

direct the NRC staff to review the impacts of a proposed licensing action on a number of environmental areas. Specifically, the environmental standard review plan directs the staffs identification and assessment of environmentally related authorizations required by Federal, State, regional, local, and affected Tribal agencies as a prerequisite to the licensing action.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment E-1.3: One commenter stated that the proposed rule will not weaken or eliminate IPZ requirements. The commenter wrote that the proposed rule would allow applicants and licensees the flexibility to propose strategies that will meet intended safety outcomes and make their case to the NRC as to why their proposed strategy can succeed. The commenter further stated that under the proposed rule, the NRC will maintain the ability to review applicant technology and ensure public safety. (NNSA2-9)

NRC Response: The NRC agrees with the comment. The comment supports the proposed rule and suggests no changes to the proposed rule.

Accordingly, the NRC did not change the rule language in response to this comment.

Contents of Emergency Plan Capabilities Comment E-2.1: Several commenters stated that the requirement to describe ingestion response planning capabilities is not sufficient and called for the proposed rule to include offsite ingestion response planning in EP requirements. One commenter recommended that the proposed rule should require that applicants and licensees describe specific ingestion pathway limits or criteria for the various food and water contamination exposure pathways. If not, the NRC should describe why such limits are not needed. Finally, one commenter wrote that onsite and offsite environmental contamination concerns are within the spectrum of credible consequences that will need to be managed within the first 4 days of a response, and plant 81

operators and local jurisdictions will not be ready to manage contamination if they do not plan for it.

One commenter criticized the proposed rules IPZ requirements, calling it a reactionary, response-oriented approach. The commenter wrote that derived intervention levels, which represent the dose threshold at which the FDA recommends consideration of protective actions, can be exceeded at a much lower level of radiation than PAGs, and this only reinforces the need for ingestion pathway preparedness and a specific IPZ. Additionally, the commenter wrote that the two examples offered in the proposed rule of government capability to interdict contaminated food and water actually led to contamination resulting in injury and death.

(BM-10, FEMA-15, UCSJT-3)

NRC Response: The NRC agrees, in part, with the comments. The concept of an IPZ was created in the 1970s. Significant improvements have been made in the Federal radiological emergency response infrastructure since then that support the identification and removal of radiologically contaminated goods from food chains. The EPA and the FDA develop the protective actions and associated guidance for State and local governments for human food and animal feed, and ingestion pathway protective actions are implemented by OROs with the support of their Federal partners. The NRC Responses to Comments B-1.6, B-4.8, and B-7.2 describe the Federal resources that would be available during an emergency. Based on the additional resources available and an improved understanding of the process and timing for identifying and removing radiologically contaminated goods from food chains, SMRs and ONTs that choose to comply with 10 CFR 50.160 do not need an IPZ.

The NRC disagrees with the suggestion that the rule should require that applicants and licensees describe specific ingestion pathway limits or criteria for the various food and water contamination exposure pathways. The NRC also disagrees with the comment that the fact that derived intervention levels can be exceeded at a much lower level of radiation than PAGs reinforces the need to require in this rule that applicants and licensees specify an IPZ. The NRC does not require currently operating nuclear power reactor licensees to describe specific ingestion pathway limits or criteria for the various food and water contamination exposure pathways, and the comments do not provide a basis for why SMRs and ONTs should be required to do so. As noted above, the EPA and the FDA develop the protective actions and associated guidance for State and local governments for human food and animal feed.

Onsite and offsite environmental contamination could occur within the first 4 days of a release of radioactive material from a nuclear power plant. The final rule requires an applicants or licensees emergency plan to describe the early-phase, short-term response actions that the licensee would take in the event of a radiological emergency at its facility. These actions include recommending applicable protective measures to the OROs if the emergency plan includes an offsite plume exposure pathway EPZ. The NRC Responses to Comments B-1.6, B-4.8, and B-7.2 describe the Federal resources available to support early-phase State and local response.

The NRC agrees with the comment that E. coli and Salmonella contamination are significantly different from radiological contamination. Biological contaminations such as E. coli and Salmonella contamination have to be present in the food chain and have a noticeable effect on the public before the food can be interdicted. However, the radiological contamination hazard presented by a fixed nuclear facility can be projected, measured, mitigated, and prevented from impacting the food chain.

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Accordingly, the NRC did not change the rule language in response to these comments.

Comment E-2.2: One commenter suggested that there is a disconnect in the proposed rule because facilities with an offsite plume exposure pathway EPZ and facilities without an offsite plume exposure pathway EPZ both would be subject to the same ingestion pathway requirements. The commenter suggested the NRC include a brief discussion that explains why additional ingestion pathway requirements are not needed if the plume exposure pathway EPZ extends beyond a site boundary.

By extension, the commenter asked if an LLWR with a 10-mile plume exposure pathway EPZ could use the exemption request process to replace its IPZ and instead meet the requirements under the proposed rule to describe offsite contamination control capabilities with the argument that an SMR with a 10-mile plume exposure pathway EPZ has the same offsite radiological risk.

The commenter further requested more information on whether an existing LLWR could use the license amendment request process under the proposed 10 CFR 50.54(q)(7) to transition to the ingestion control requirements under proposed 10 CFR 50.160. The commenter asserted that the NRC should base their response to these questions on a purely technical comparison, rather than citing their definitions. (BM-9, BM-11)

NRC Response: The NRC disagrees with the comments. The NRC disagrees with the suggestion that there is a disconnect in the proposed rule because facilities with an offsite plume exposure pathway EPZ and facilities without an offsite plume exposure pathway EPZ have the same ingestion pathway requirements. The basis for and timeframes of plume exposure pathway EPZs and IPZs are independent of each other. A plume exposure pathway EPZ is a planning tool to determine the area where the preplanning of early-phase, short-term protective actions to provide dose savings to the public closest to the facility would be warranted. Similarly, an IPZ is a long-term tool to determine the area where preplanning would be needed for contamination to a level warranting food and water interdictions based on public consumption and exceedance of FDA PAGs. Regardless of whether an accidental radioactive release was to exceed the EPA early-phase PAGs, the long-term FDA food and water PAGs would still need to be evaluated.

Any LLWR licensee with a 10-mile plume exposure pathway EPZ will have been licensed under 10 CFR 50.47(b) and Appendix E to 10 CFR Part 50 and is not eligible to use the provisions of this final rule. Such a licensee cannot use a license amendment request to replace its IPZ with the ingestion control requirements of this final rule. Within 10 CFR Part 50, 10 CFR 50.54 describes the conditions of licenses. Specifically, 10 CFR 50.54(q) describes how a licensee is to maintain compliance with the applicable EP requirements, which in the case of the comment includes 10 CFR 50.47(b) and Appendix E to 10 CFR Part 50. If a licensee were to switch to only the IPZ requirements of 10 CFR 50.160, then the licensee would no longer be meeting the regulatory requirements of 10 CFR 50.47(b) and Appendix E to 10 CFR Part 50, and the NRC could not approve such a request. An LLWR licensee using the exemption process would have to provide an explanation of how an exemption from the 10 CFR 50.54(q) requirement meets the requirements for specific exemptions in 10 CFR 50.12. The commenter did not provide a basis.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment E-2.3: One commenter said that the proposed rules requirements that licensees demonstrate and have the ability to recommend protective actions to offsite authorities, make notifications to external organizations with the necessary interdiction capabilities, monitor and 83

assess radiological conditions to support protective actions, and maintain staffing needed to implement said functions, ensure that ingestion pathway mitigation capabilities are provided and can be used in the event of an accident. (NNSA2-10)

NRC Response: The NRC agrees with the comment. The comment supports the proposed rule and suggests no changes to the proposed rule.

Accordingly, the NRC did not change the rule language in response to this comment.

NRC Question: If the applicant or licensee provides an adequate description of the existing Federal, Tribal, State, and local Federal capabilities to interdict contaminated food and water, would the need for an IPZ exist?

Comment E-3.1: Several commenters observed that the need for an IPZ would exist even if an applicant provides adequate description of existing capabilities to interdict contaminated food and water because of the unique problems presented by radioactive contamination even under small amounts. One commenter suggested that the examples offered in the proposed rule of the governments ability to interdict E. coli and Salmonella contamination are significantly different from radiological contamination, which requires additional EP.

One commenter stated that under the proposed rule there would be no IPZ if a facility does not have an offsite plume exposure pathway EPZ. The commenter said that without this coordination plan, State and local jurisdictions may not have the expertise necessary to respond to a radiological emergency under their all-hazards plan. The commenter suggested that EP for all nuclear plants should include a mechanism to ensure offsite radiological assessment and planning beyond the plume exposure pathway EPZ. (NJDEP-8, NJDEP-25, CRCPD-5, CRCPD-25)

NRC Response: The NRC disagrees with the comments. For the reasons provided in the NRC Responses to Comments E-1.1 and E-2.1, the NRC is not requiring a formal ingestion pathway EPZ in the final rule.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment E-3.2: One commenter suggested that an IPZ would not be needed if an applicant provides an adequate description of existing capabilities to interdict contaminated food and water. The commenter said that an IPZ is not needed under these circumstances as there are numerous Federal, regional, and State resources available to monitor food and water sources as needed. The commenter asserted that the NRC does not require an IPZ for non-power reactor facilities that do not have an offsite plume exposure pathway EPZ. The commenter asserted that IPZs are not needed for any facilities where the plume exposure pathway EPZ does not encompass offsite areas. (NEIA-17)

NRC Response: The NRC agrees with the comment. The comment supports the proposed rule and suggests no changes to the proposed rule.

Accordingly, the NRC did not change the rule language in response to this comment.

Comprehensive All-Hazards Plan 84

Comment E-4.1: One commenter wrote that the proposed rule does not provide a FEMA evaluation of the changes to IPZ requirements or a discussion of the effectiveness of ad hoc responses to previous radiological incidents. The commenter also wrote that under the proposed rules rationale, IPZ requirements could be eliminated for LLWRs. (UWJB-10)

NRC Response: The NRC disagrees with the comment. The NRC has given great consideration to all aspects of offsite emergency response and recognizes that State and local all-hazards response plans are tested by real events almost daily across the United States. For the reasons explained in the proposed rule SOC and the NRC Responses to Comments E-1.1 and E-2.1, the NRC is not requiring a formal ingestion pathway EPZ in the final rule. The NRC Responses to Comments B-1.6, B-4.8, and B-7.2 describe the Federal resources available to OROs to respond to a radiological emergency.

Accordingly, the NRC did not change the rule language in response to this comment.

F. Implementation Schedule Comment F-1: One commenter suggested that the NRC and DOE increase funding for public engagement in communities where SMRs will be deployed. The commenter further urged the NRC to increase public outreach as it would build public trust. The commenter suggested public engagement sessions and other means for the public to participate, such as group discussions and public comment periods. (AN9-1)

NRC Response: The NRC agrees, in part, with the comment. The NRC agrees that public engagement is important. The NRC does not agree that funding for public engagement is within the scope of the rulemaking. The NRC notes that the licensing process includes a number of opportunities for public engagement in communities where facilities may be located, such as draft environmental impact statement public scoping meetings and government-to-government meetings. These public engagement opportunities arise after an applicant submits a license application and the NRC accepts it for review. Openness is among the NRCs organizational values and Principles of Good Regulation, and it is the NRCs general policy to share information with the public in a transparent manner.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment F-2: One commenter wrote that some applicants will seek exemptions from existing NRC EP requirements. The commenter suggested that the final rule provide clarity regarding the processing of applications submitted before the completion of the rulemaking and address the integration of approved alternative exemptions with the requirements of the final rule. The commenter wrote that the rule should also recognize that existing applicants will adhere to their compliance dates established through the licensing process. (NEIA-19)

NRC Response: The NRC disagrees with the comment. This final rule is voluntary, so applicants need not comply with it. An applicant with an application being reviewed by the NRC when this rule goes into effect that chooses to comply with this rule would need to amend its application to meet the requirements of this rule. In the final rule, 10 CFR 50.54(q)(7) allows any existing or future holder of an OL under 10 CFR Part 50 or a 10 CFR Part 52 COL for an SMR or non-LWR, or any future holder of an OL for an NPUF, to change its emergency plan to comply with 10 CFR 50.160 by submitting a license amendment request with the proposed changes to its emergency plan.

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Accordingly, the NRC did not change the rule language in response to this comment.

Comment F-3: One commenter noted that for sites with a plume exposure pathway EPZ encompassing areas outside the owner controlled area, implementation of this rule will be influenced by FEMA requirements. Also, the proposed rules implementation will be influenced by the EPA as it issues the PAG referenced in the proposed rule. (NEIA-20)

NRC Response: The NRC agrees, in part, with the comment. The NRC agrees that licensee implementation of some of the final rule requirements may be affected by FEMA evaluations of OROs exercise performance. However, the NRC disagrees that implementation of the final rule would be influenced by the EPA because the EPA issues PAGs. This comment assumes two things: (1) the EPA issues a new PAG, and (2) the EPAs issuance of a new PAG would cause the NRC to change this rule. The NRC has no knowledge that the EPA intends to issue a new PAG. Even if the EPA issued a new early-phase PAG, the new PAG may not compel a change to this final rule that would influence implementation of this rule.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment F-4: One commenter stated that it has not identified any unintended consequences of the proposed rule. (NEIA-21)

NRC Response: The comment suggests no changes to the proposed rule.

Accordingly, the NRC did not change the rule language in response to this comment.

G. Administrative and Clarifying Changes to the Regulations Comment G-1: Two commenters wrote that the reference to FEMA deficiencies under 10 CFR 50.54(gg)(1) should be changed to Level 1 Findings to reflect FEMAs language.

(BM-16, DBY-8)

NRC Response: The NRC agrees, in part, with the comments. The NRC acknowledges that FEMA has changed its terminology from deficiency to level 1 finding. However, FEMA has not updated its regulations to reflect this change. As a result, the NRC uses the term deficiencies rather than level 1 findings in this final rule.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment G-2: One commenter stated that the last sentence in the third paragraph in Section II.B of the proposed rule FRN references hazardous chemicals, NUREG-1537, and NUREG-1520, Revision 1, Standard Review Plan for the Review of a License Application for a Fuel Cycle Facility, issued May 2010 (ADAMS Accession No. ML101390110), but the proposed rule does not explain their relevancy or relationship to EP for SMRs and ONTs. The commenter explained that EP is generally associated with radiological hazards and not necessarily hazardous chemicals. The commenter also noted that DG-1350 mentions hazardous chemicals and 10 CFR 70.4, Definitions, but not the relationship to NUREG-1537 or NUREG-1520. The commenter requested that the NRC clarify how hazardous chemicals are relevant to the proposed rule and DG-1350 and correct any inconsistency in listing of references. (BM-4)

NRC Response: The NRC disagrees with the comment. The discussion in the proposed rule FRN referenced in the comment is in the background section of the notice of proposed 86

rulemaking and describes the existing EP framework for NPUFs. As stated at the beginning of Section I.B. of the notice, the purpose of this discussion is to demonstrate how EP can vary depending on the type of facility. The NRC uses hazardous chemicals only as an example of an emergency planning consideration for a radioisotope production facility. As a result, there is no need to clarify this discussion.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment G-3: One commenter recommended that the subsection title Performance-based approach under Proposed Changes in Section III. Discussion, of the proposed rule FRN should be changed to Performance-based approach to Emergency Planning. The commenter also suggested that the title Technology-Inclusive Approach should read Technology-Inclusive Approach to Emergency Planning to be consistent with the subheading Risk-Informed and Consequence-Oriented Approaches to Emergency Planning. (BM-8)

NRC Response: The NRC agrees with the comment. Revising the headings in Section III as suggested in the comment would improve the consistency of the FRN.

Accordingly, the NRC revised headings in Section II of the final rule FRN to read, Performance-Based Approach to Emergency Planning as opposed to Performance-Based Approach and Technology-Inclusive Approach to Emergency Planning as opposed to Technology-Inclusive Approach.

Comment G-4: One commenter suggested that the phrase This majority of the provisions in the third sentence of the first paragraph in Section XI should read The majority of the provision. (BM-15)

NRC Response: The NRC agrees, in part, with the comment. To improve clarity, the NRC agrees that the word This should be revised to The. However, the word provisions needs to remain plural because the NRC is referring to more than one provision.

Accordingly, the NRC revised the third sentence of Section XI in the final rule FRN to read The majority of the provisions.

Comment G-5: One commenter suggested changing the phrase The NRC will not issue an initial operating license to a licensee unless in 10 CFR 50.160(b) to read The NRC will not issue an initial operating license to an applicant because the applicant is not a licensee until after the NRC issues the initial OL. (BM-17)

NRC Response: The NRC agrees, in part, with the comment. An applicant is not a licensee until the NRC issues the license. However, the NRC revised 10 CFR 50.160(b) from the proposed rule to state that the reasonable assurance finding made under 10 CFR 50.47(a)(1) necessary to issue an OL, COL, or ESP to an applicant complying with 10 CFR 50.47 and Appendix E to Part 50 is also necessary to issue an OL, COL, or ESP to a power reactor applicant complying with 10 CFR 50.160.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment G-6: One commenter suggested that, under proposed 10 CFR 50.160(b)(1)(iii)(C),

the phrase and make notifications to response personnel and organizations be changed to and make notifications to onsite and offsite response personnel and organizations.

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The commenter also suggested that a similar revision be made under 10 CFR 50.160(b)(1)(iii)(F)(1), to change the phrase and report radiological conditions to the response organization to read and report radiological conditions to the onsite and offsite response organizations.

Also, in 10 CFR 50.160(b)(1)(iii)(F)(3), the commenter recommended that the NRC change the phrase and report to the response organization to read and report to the onsite and offsite response organizations.

Finally, the commenter suggested that the NRC change the phrase report to the response organization in 10 CFR 50.160(b)(1)(iii)(F)(4), to read report to the onsite and offsite organizations. (BM-18)

NRC Response: The NRC agrees, in part, with the comments. The references to response organization in proposed 10 CFR 50.160 (F)(1), (F)(3), and (F)(4) should be clarified.

However, not all of the response organizations referenced in these provisions refer to onsite and offsite organizations, as the comments suggest. Proposed 10 CFR 50.160(b)(1)(iii)(C) would have required the licensee to have the capability to establish and maintain effective communications with the licensees ERO. The licensee would also have to have the capability to make notifications to response personnel and organizations who may have responsibilities for responding during emergencies. Thus, the first part of this provision refers to the ERO, and the second part refers to the NRC and OROs. The NRC did not change this provision in the final rule.

In the proposed rule SOC, the NRC explained that the information to be reported under 10 CFR 50.160(b)(1)(iii)(F)(1), (3), and (4) (i.e., radiological conditions; the extent and magnitude of damage to the core or other vessel containing irradiated special nuclear material; and the extent and magnitude of all radiological releases, including releases of hazardous chemicals produced from licensed material, respectively) would be reported to the ERO.

However, in light of this comment, the NRC determined that that information would need to be reported to only certain personnel within the ERO. Therefore, the NRC changed these rule provisions, so the information is reported to the applicable response personnel.

Accordingly, the NRC revised 10 CFR 50.160(b)(1)(iii)(F)(1), 10 CFR 50.160(b)(1)(iii)(F)(3), and 10 CFR 50.160(b)(1)(iii)(F)(4) in the final rule to change response organization to applicable response personnel.

Comment G-7: One commenter explained that Section II, Background, Subsections A and B, reference two most notable EP guidance documents, NUREG-0654/FEMA-REP-1, Revision 2, Criteria for Preparation and Evaluation of Radiological Emergency Response Plans and Preparedness in Support of Nuclear Power Plants, issued December 2019 (ADAMS Accession No. ML19347D139), and RG 1.219, Revision 1, Guidance on Making Changes to Emergency Plans for Nuclear Power Reactors, issued July 2016 (ADAMS Accession No. ML16061A104) but do not reference NUREG-0800, Section 13.3, Emergency Planning, and Section 14.3.10, Emergency PlanningInspections, Tests, Analyses, and Acceptance Criteria, issued March 2007 (ADAMS Accession Nos. ML063410307 and ML070730206), which apply to 10 CFR Part 50 and 10 CFR Part 52 applications. The commenter asked that these sections of NUREG-0800 be referenced as additional EP guidance documents. The commenter also requested that the NRC add a reference to RG 1.233 under Section XVII because it also addresses EP and is relevant to DG-1350. (BM-3) 88

NRC Response: The NRC agrees with the comment. NUREG-0800, Section 13.3, provides the criteria that the NRC staff uses in reviewing applicants emergency plans as described in the SARs for license applications to construct and operate LWR nuclear power plants.

NUREG-0800, Section 14.3.10, provides the criteria that the NRC staff uses in reviewing applicants proposed inspections, tests, and analyses applicable to emergency planning that the licensee will perform and the associated acceptance criteria. RG 1.233 provides guidance on the selection of licensing-basis events; classification and special treatments of structures, systems, and components; and assessment of defense in depth for non-LWRs. These applicants can use RG 1.233 in the development of the analysis required by 10 CFR 50.33(g) for determining EPZ size.

Accordingly, the NRC revised Section I.A., Existing Emergency Preparedness Framework for Nuclear Power Reactors, and the Availability of Documents table in Section XVII of the final rule FRN to include references to NUREG-0800, Sections 13.3 and 14.3.10, and RG 1.233.

H. Scope of the Proposed Rule General Comments on the Scope of the Proposed Rule Comment H-1.1: One commenter stated that the proposed rule does not provide a sufficient technical or adequate justification for excluding LLWRs from its scope. The commenter suggested that instead, the proposed rule notes that LLWRs are not included as they already have an EP licensing framework, and licensees have not expressed clear interest in changing that framework. The commenter said that the nuclear industry has continuously encouraged the NRC to adopt some aspects included in the proposed rule, and the term clear interest is subjective and insufficient to justify an NRC policy position. The commenter suggested that at a minimum, the proposed rule should provide an adequate technical justification to support the exclusion of LLWRs. Finally, the commenter noted that the proposed rule, in the section Risk-Informed and Consequences-Oriented Approaches to Emergency Planning, provides a technical relationship between dose standards for LLWRs and SMRs which appear contrary to the non-technical justification(s) given for excluding LLWRs. (BM-1, BM-2)

NRC Response: The NRC disagrees with the comments. The NRC provided a justification in the proposed rule FRN for excluding LLWRs from the scope of the proposed rule. This justification is a policy decision expressed by the Commission several times in various staff requirements memoranda (SRM) (e.g., SRM-SECY-16-0069, Rulemaking Plan on Emergency Preparedness for Small Modular Reactors and Other New Technologies, dated June 22, 2016 (ADAMS Accession No. ML16174A166); SRM-SECY-18-0103, Proposed RuleEmergency Preparedness for Small Modular Reactors and Other New Technologies, dated December 17, 2019 (ADAMS Accession No. ML19351C729)). The comments provide no substantive support for the claim that the Commissions policy decision is insufficient and that the nuclear industry has continuously encouraged the NRC to adopt some aspects included in the proposed rule. In contrast, when given the opportunity to comment on the proposed rule, the industrys representative stated, [T]here is no pressing need for a performance-based, consequence-oriented approach to EP for large LWRs. See the comment from the NEI, , page 2, dated September 22, 2020 (ADAMS Accession No. ML20267A326).

The NRC disagrees that the discussions in the proposed rule FRN concerning dose standards for SMRs and ONTs and LLWRs and the technical basis for plume exposure pathway EPZ 89

sizes are contrary to the nontechnical policy decision for excluding LLWRs from the rule.

Those discussions concern the dose criterion when protective measures are recommended.

That criterion is the same for LLWRs as it is for SMRs and ONTs, but the EP framework for the two groups of licensees does not need to be the same. In this final rule, the NRC offers SMRs and ONTs an alternative EP framework for the reasons provided in the proposed rule FRN and comments such as Comment D-1.13, and the NRC responses to those comments.

Accordingly, the NRC did not change the rule language in response to these comments.

NRC Question: Are the proposed non-light-water reactor, non-power production or utilization facility, and small modular reactor definitions in § 50.2 sufficient to address EP for existing and anticipated technologies? Are there any unintended consequences of including each of these classes of facilities within the scope of this proposed rule?

Comment H-2.1: Several commenters said that the proposed definitions for non-LWR, NPUF, and SMR are adequate. One commenter wrote that the definitions are sufficient to address EP activities for existing technologies, but that they will withhold judgment on anticipated technologies. (SBT-14, NJDEP-12, CRCPD-11)

NRC Response: The NRC agrees, in part, with the comments. The definitions of non-light water reactor, non-power production or utilization facility, and small modular reactor in the rulemaking are adequate to address EP not only for existing technologies but also for anticipated technologies.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment H-2.2: One commenter wrote that the NRCs explanation of why it used MW(t) instead of megawatt electric (MW(e)) was confusing. Specifically, the commenter points out that MW(t) reflects a reactors maximum design output as an allowable limit for power operation, while MWe reflects the overall plant electrical output efficiency, which can vary. (BM-5)

NRC Response: The NRC agrees, in part, with the comment. The NRC did not base its decision to use the thermal power equivalent of electric power generating capacity MW(t) on the distinction between MW(t) and electric power generating capacity MW(e). As the NRC explained in the proposed rule FRN, the NRC used MW(t) in the definition of SMR instead of MW(e) because MW(e) is not a criterion the NRC uses to determine EP requirements. For example, in 10 CFR 50.33(g) and 10 CFR 50.47(c)(2), EPZ size may be determined on a case-by-case basis for reactors with an authorized power level less than 250 MW(t).

Accordingly, the NRC did not change the rule language in response to this comment.

Comment H-2.3: One commenter wrote that the proposed rule should indicate that an SMR can have a licensed thermal power up to 1,000 MW(t) and that this limit applies to each module in a facility rather than the total thermal power of all modules in a facility. The commenter said that it did not identify any unintended consequences of including these classes of facilities within the scope of the proposed rule. (NEIA-2)

NRC Response: The NRC agrees with the comment. The proposed rules definition of small modular reactor does not clearly state that the 1,000-MW(t) limit applies to each module of an SMR. The proposed rules definition of small modular reactor is a power reactor, licensed under 10 CFR 50.21, Class 104 licenses; for medical therapy and research and development 90

facilities, or 10 CFR 50.22, Class 103 licenses; for commercial and industrial facilities, to produce heat energy up to 1,000 MW(t), that may be of modular design as defined in 10 CFR 52.1. Additionally, 10 CFR 52.1 defines modular design as follows:

a nuclear power station that consists of two or more essentially identical nuclear reactors (modules) and each module is a separate nuclear reactor capable of being operated independent of the state of completion or operating condition of any other module co-located on the same site, even though the nuclear power station may have some shared or common systems.

One reading of the proposed rule definition of small modular reactor is that an SMR is a power reactor that may consist of two or more separate, independent reactors, and each of the reactors in an SMR may produce heat energy up to 1,000 MW(t). Another reading of the proposed definition is that an SMR is a power reactor that is licensed to produce heat energy up to 1,000 MW(t) and may be of modular design. In that case, the 1,000-MW(t) limit would apply to the facility. To clarify this potential ambiguity, the NRC in the final rule revised the definition of small modular reactor to read a power reactor, which may be of modular design as defined in § 52.1 of this chapter, licensed under § 50.21 or § 50.22 to produce heat energy up to 1,000 megawatts thermal per module. This is consistent with the discussion in the proposed rule SOC of the definition of small modular reactor in 10 CFR 171.5, Definitions:

The § 171.5 definition of small modular reactor means, for the purpose of calculating fees, the class of light-water power reactors having a licensed thermal power rating less than or equal to 1,000 MW(t) per module.

The NRC is also unaware of any unintended consequences of including non-LWRs, NPUFs, and SMRs within the scope of the final rule.

Accordingly, the NRC changed the rule language in response to this comment.

Comment H-2.4: One commenter stated that it is unclear what the term facility means in regard to SMRs with multiple modules in one building and questioned if the term is referring to one module or the entire plant. The commenter suggested that the NRC define the term facility for multimodule plants and that such a definition should align with the discussion of consequences per module discussed in the rule. (NSA-5)

NRC Response: The NRC agrees, in part, with the comment. References to per module consequences could be confusing in light of the use of the term facility to refer to an entire SMR or ONT. However, because the NRC refers to per module consequences only twice in the FRN and uses the term facility to mean all of the potential modules of a single SMR or ONT, the NRC did not define the term facility in the final rule.

Accordingly, the NRC did not change the rule language in response to this comment.

NRC Question: Should the NRC consider a performance-based, consequence-oriented approach to EP for entities besides SMRs and ONTs (e.g., LLWRs, fuel cycle facilities, and currently operating NPUFs) in a future rulemaking?

Comment H-3.1: Several commenters expressed opposition to potentially using a performance-based, consequence-oriented approach to EP for other reactors. One commenter wrote that they supported a performance-based approach to EP, but reserved judgment on 91

expanding it to ONTs until additional information becomes available. One commenter wrote that requesting comments on the applicability of the proposed rule to the existing fleet is outside the scope of the rulemaking and premature. Another commenter wrote that the NRC should continue to embrace a performance-based, consequence-oriented approach to EP, but changes are not required for existing technologies. One commenter wrote that other reactors such as LLWRs should be included in a new rule for a technically defensible EPZ, but the plume exposure pathway EPZ should be kept at minimum of 10 miles. The commenter opposed adding LLWRs to the scope of the proposed rule and wrote that this question would open the door to a reduced plume exposure pathway EPZ size for LLWRs. (SBT-16, FEMA-5, NJDEP-14, CLA-10, UCS-18, UWJB-7)

NRC Response: The NRC agrees, in part, with the comments. The NRC agrees that this rules performance-based and consequence-oriented EP framework should be available to SMRs and ONTs but not LLWRs at this time and that changes to the existing regulations for the currently operating reactors are not necessary. The NRC disagrees with comments regarding the effects of including LLWRs in this rulemaking and will use those comments to inform future considerations by the NRC.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment H-3.2: Several commenters expressed support for including LLWRs within the scope of the proposed rulemaking. One commenter wrote that regulations for LLWRs would be improved if organized around a performance-based and consequence-oriented framework, and such a framework should be made available to such facilities as an option. The commenter stated that there is some dissonance created by the proposed regulations creation of two different standards for a reactor requiring an offsite plume exposure pathway EPZ: standards and procedures under 10 CFR 50.47 which are organized around the generic 10-mile plume exposure pathway EPZ, and those for the proposed 10 CFR 50.160(b)(i-iv)(A) and (B) which are based on the 10-mSv TEDE standard. The commenter wrote that the EP framework under the proposed rule highlights that the current requirements, particularly a generic 10-mile plume exposure pathway EPZ, are arbitrary in nature, and it would serve the public well to allow existing facilities to opt into the new framework. One commenter wrote that LLWRs should be able to adopt a performance-based approach if there is evidence it will not decrease the effectiveness of the emergency plan, but it is doubtful many will choose to do this due to the potential for unintended consequences. One commenter wrote that the NRC can regulate a variety of designs with the proposed framework, and it should also be applied to the framework currently in development for advanced reactors. (NJDEP-13, NSA-24, HF-3, HF-4, HF-5, CLA-11)

NRC Response: The NRC agrees, in part, with the comments. The NRC agrees that regulations for LLWRs could be enhanced using a performance-based approach. However, in SECY-14-0038, Performance-Based Framework for Nuclear Power Plant Emergency Preparedness Oversight, dated April 4, 2014 (ADAMS Accession No. ML13238A018), the NRC staff concluded that, although a performance-based regimen could enhance EP oversight, the existing program for LLWRs provides reasonable assurance of adequate protection of public health and safety, and licensees for these plants have not expressed a clear interest in changing the current framework. In SRM-SECY-14-0038, dated September 16, 2014 (ADAMS Accession No. ML14259A589), the Commission approved the staffs recommendation to not pursue rulemaking to provide a performance-based EP framework for LLWRs.

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The NRC disagrees that having two different standards for a reactor requiring an offsite EPZ creates dissonance. The EP framework in 10 CFR 50.47(b) and Appendix E to 10 CFR Part 50 and the provisions of 10 CFR 50.160 have distinct regulatory approaches and entry conditions.

For example, 10 CFR 50.47(b) and Appendix E to 10 CFR Part 50 establish a prescriptive capability approach that was developed to be generically applicable to the current fleet of reactors after many of the plants were built. Additionally, 10 CFR 50.160 is forward-looking and not limited by potential reactor technologies. An applicant complying with the 10 CFR 50.160 framework could have a 10-mile EPZ like a current LLWR, a site boundary EPZ, or a different sized-EPZ. The performance-based approach of the final rule allows for a scalable plume exposure pathway EPZ size and emergency plans that are appropriate for the applicant based on several factors such as location, source term, accident likelihood, and meteorology.

The NRC also disagrees that the 10 CFR 50.160 EP framework highlights that the EP requirements under 10 CFR 50.47(b) and Appendix E to 10 CFR Part 50, particularly a generic 10-mile EPZ, are arbitrary. In adopting the current 10-mile EPZ concept, the Commission decided to have a conservative emergency planning policy in addition to the conservatism inherent in the defense-in-depth philosophy captured in NUREG-0396 and endorsed in the Commissions policy statement, Planning Basis for Emergency Responses to Nuclear Power Reactor Accidents (44 FR 61123; October 23, 1979).

The NRC agrees that, under this rule, the agency can regulate a variety of reactor designs; however, application of performance-based requirements using a graded approach based on site-specific consequence analyses to the regulatory framework currently under development for advanced reactors would be beyond the scope of this rulemaking.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment H-3.3: Two commenters agreed that the NRC should consider a performance-based and consequence-oriented approach to EP for entities besides SMRs and ONTs. One commenter wrote that this should not be a priority rulemaking as it will benefit a limited number of facilities. (NEIA-3, CRCPD-13)

NRC Response: The NRC agrees with these comments. Consistent with SRM-SECY-14-0038, the NRC will continue to assess the NRCs EP program for entities besides SMRs and ONTs for the possibility of moving to a performance-based framework in the future.

Accordingly, the NRC did not change the rule language in response to these comments.

NRC Question: If the NRC considers a performance-based, consequence-oriented approach to EP for entities other than SMRs and ONTs, what criteria should such entities be required to meet to use a performance-based, consequence-oriented approach to EP in a future rulemaking?

Comment H-4.1: Two commenters wrote that criteria for a performance-based, consequence-oriented approach for other entities should be built on concepts established in NUREG/CR-7160, Emergency Preparedness Significance Quantification Process: Proof of Concepts, issued June 2013 (ADAMS Accession No. ML13164A285). The commenters also wrote that current NRC EP performance indicators could be supplemented by additional indicators. (NJDEP-15, CRCPD-14) 93

NRC Response: The NRC agrees with these comments. The concepts established in NUREG/CR-7160 could be useful in a future performance-based, consequence-oriented EP rulemaking.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment H-4.2: One commenter said that DG-1350 presents appropriate criteria for a performance-based, consequence-oriented approach to EP for entities other than SMRs.

(NEIA-4)

NRC Response: The NRC agrees with the comment. The criteria in RG 1.242 could be useful in future performance-based, consequence-oriented EP rulemaking.

Accordingly, the NRC did not change the rule language in response to this comment.

NRC Question: If the NRC does not consider a performance-based, consequence-oriented approach to EP for entities other than SMRs and ONTs, should the NRC offer mechanisms (other than the existing exemption process) that would allow other entities to request NRC approval to use the EP framework proposed in this rulemaking?

Comment H-5.1: Two commenters wrote that a rule change would be required for facilities outside of SMRs and ONTs to use the proposed EP framework. One commenter suggested changing EP regulations so licensees other than SMRs and ONTs can choose between either the existing or proposed framework and allowing the option under either framework to determine a plume exposure pathway EPZ size through site-specific analysis. (NJDEP-16, NEIA-5, CRCPD-15)

NRC Response: The NRC agrees, in part, with the comments. Rulemaking would be required to allow entities other than SMRs and ONTs to request NRC approval to use the EP framework in 10 CFR 50.160.

The NRC cannot agree at this time with the comment that entities other than SMRs and ONTs should be able to have the option, through a future rulemaking, to determine plume exposure pathway EPZ size through site-specific analysis even when not using a performance-based, consequence-oriented approach to EP. However, the NRC will use that comment to inform future agency considerations.

Accordingly, the NRC did not change the rule language in response to these comments.

I. Draft Regulatory Analysis General Comments on the Draft Regulatory Analysis Comment I-1.1: One commenter asked that the NRC clarify how the economic benefit received from an SMR license is related to the costs and benefits of the proposed rule and associated guidance. The commenter wrote that the proposed rules regulatory analysis (RA) includes savings to the nuclear industry and NRC that are different than what is described as fair in the proposed rules discussion of the NRCs fee regulations. The commenter asked that the NRC explain this discrepancy. In addition, the commenter requested that the NRC clarify the distinction between MW(t) and MW(e) and remove or explain the reference to 10 CFR Part 171, 94

Annual fees for reactor licenses and fuel cycle licenses, including holders of certificates of compliance, registrations, and quality assurance program approvals and government agencies licensed by the NRC, and the discussion of fairness with regard to the payment of annual fees.

(BM-6, BM-7)

NRC Response: The NRC disagrees with the comments. The economic benefit received from an SMR license due to aspects of the fee rule is not related to the costs and benefits of this final rule. The comment is conflating the issue of fairness in the fee rule with the context in which it was used in the proposed rule FRN (i.e., the definition of the term small modular reactor), and those two usages of the term are not connected.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment I-1.2: Several commenters wrote that the proposed rule does not completely account for costs related to public health and safety. One commenter wrote that the proposed rule considers benefits only to the licensee and applicants and should include costs related to failure of a licensee and a community to be adequately prepared in the event of an accident and release of radioactive materials. Additionally, the commenter wrote that the NRC does not have adequate information about the design of facilities and site-specific characteristics to fully evaluate costs.

One commenter wrote that the proposed rule should include protections for accidents in Category C for the worst core melt sequences. The commenter wrote that the alternative in the RA with a requirement for a substantial reduction in risk similar to the evaluation in NUREG-0396 should be included in the proposed rule, and as a result, the rule is inconsistent with the current planning basis and the RA. (UW2-21, UCS-8)

NRC Response: The NRC agrees, in part, with the comments. The NRC disagrees that the proposed rule did not account for costs related to public health and safety. The proposed rule would provide an alternative EP framework that would afford the same level of protection as exists under current regulations. Therefore, the proposed rule would have no incremental impact to public health, safety, and the community. The same holds true for the final rule. If an applicant or licensee complies with the final rules emergency plan requirements, then the NRC has reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency at the licensed facility.

With regard to the comment addressing the statement in the proposed rule RA related to substantial reduction in risk to public health and safety, the NRC acknowledges that the language was erroneously included in the RA. The NRC deleted this language from the final rule RA. For additional explanation of why the proposed rule did not address the issue of substantial reduction in risk, please refer to the NRC Response to Comment D-3.6.

The NRC disagrees that the worst core melt sequences are not accounted for in the current EP planning basis. NUREG-0396 defines Class 9 events as sequences leading to total core melt and consequent degradation of the containment boundary and those events leading to gross fuel clad failure or partial melt with independent failures of the containment boundary.

Today, these events are referred to as BDBAs. RG 1.242 discusses in both Appendix A and Appendix B how applicants and licensees should include the analysis of BDBAs.

Accordingly, in response to these comments, the NRC updated the RA to delete the language applicants would also need to show a substantial reduction in risk to public health and safety at 95

the chosen plume exposure pathway EPZ outer boundary for very severe accidents similar to the evaluation in NUREG-0396.

Comment I-1.3: One commenter noted that the RA states that a qualitative consideration of the proposed rule is promotion of a performance-based framework. The commenter said that because there is no performance history for SMRs and ONTs, it is not appropriate to promote the qualitative benefits of a performance-based regulatory framework. (UW2-22)

NRC Response: The NRC disagrees with the comment. A performance-based framework for SMRs and ONTs is appropriate, and qualitative benefits of this framework can be assumed.

Under the final rule, the NRC will review performance indicators provided by the applicant, and RG 1.242 provides guidance on this topic to applicants and licensees. The NRC expects that operational experience will be obtained during the design and testing phases of SMRs and ONTs. Additionally, the performance-based concept allows for NRC inspection of licensees meeting or failing performance goals. The performance criteria are meant to be technology inclusive and do not require prior performance. Therefore, the performance-based framework offers regulatory efficiency to the applicants and licensees, which is discussed qualitatively in the RA.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment I-1.4: One commenter wrote that the proposed rule should recognize the averted costs of avoiding an offsite EP program, which would amount to $135 million in savings over the 40-year life of a facility. (NEIA-22)

NRC Response: The NRC disagrees with the comment. The NRC disagrees that the RA does not address the averted costs of offsite EP programs. The purpose of an RA is to discuss the different incremental costs between alternatives. The RA discusses, in detail, in the final two paragraphs of Section 5.1 that these costs would be averted under both Alternatives 1 and 2 and are therefore not considered as averted costs under the rule. The NRC added language to this part of the RA to indicate that these costs could be averted via exemption request without the rule being in effect. Therefore, the NRC did not estimate the cost of offsite EP for this rulemaking.

Accordingly, the NRC did not change the rule language in response to this comment.

NRC Question: The NRC is seeking information on the incremental cost estimates for any additional PRA modeling necessary to generate the credible accident sequences and the development of the source terms used in determining a site-specific EPZ size.

Comment I-2.1: Two commenters wrote that cost estimates for additional PRA modeling would be dependent on the type of facility and given that there is no history or track record to base estimates on, it is not possible to develop accurate cost estimates at this time. The commenter suggested that the NRC provide additional guidance on how to select credible accident sequences.

The other commenter wrote that the final cost for a sizing analysis would be dependent on the number of sequences determined to be credible and potentially bounding for an EPZ analysis.

The commenter wrote that, assuming four candidate sequences, the total cost would be

$100,000. The commenter added the incremental cost could vary based on the complexity of the design. (NJDEP-26, CRCPD-26, NEIA-18) 96

NRC Response: The NRC reviewed the information provided by the commenters and has used this additional information to inform the RA. The final rule may require applicants to perform additional analyses and, as a result, incur additional costs.

Accordingly, the NRC has updated the final rule RA to account for these additional incremental costs.

J. Information Collection Comment J-1: One commenter wrote that the information collection is necessary as it would allow the NRC to better evaluate a licensees EP program elements required by this rule.

(NEIA-23)

NRC Response: The NRC agrees with the comment. The NRC agrees that information collection will allow the agency to evaluate a facilitys EP program.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment J-2: One commenter noted that there are no opportunities for minimizing the burden of the proposed information collection. The commenter added that the NRC offers several ways of electronic transmission and submittal, and the NRC is able to receive performance indicator data electronically as part of the ROP. Therefore, the commenter expressed that all responses likely will be filed electronically. (NEIA-26)

NRC Response: The comment suggests no changes to the proposed rule.

Accordingly, the NRC did not change the rule language in response to this comment.

K. Draft Environmental Assessment Comment K-1: One commenter asked the NRC to revisit portions of the proposed rule that place long-term, offsite hardships related to EP on Tribes. The commenter wrote that the draft environmental assessment did not fully analyze the disproportionate environmental justice and socioeconomic concern related to these hardships. (SBT-6)

NRC Response: The NRC disagrees with the comment. Environmental justice and socioeconomic concerns of the Tribes in relation to 10 CFR 50.160 will be addressed during a license application involving the EP framework in 10 CFR 50.160 in accordance with the Commissions Tribal Policy Statement. The Tribal Policy Statement is intended to encourage and facilitate Tribal involvement in activities under NRC jurisdiction. It provides guidance to ensure consistency across the agency in government-to-government relations with Federally recognized Tribes. The Policy Statement also underscores the NRCs commitments to conducting outreach to Tribes and engaging in timely consultation and to coordinating with other Federal agencies. The NRC expects all program and regional office consultation and coordination practices to be consistent with or adhere to the NRC Tribal Policy Statement.

This final rule does not place new or different long-term hardships related to EP on Tribal communities relative to the current EP requirements. The NRC will not approve an emergency plan that does not meet the NRCs EP requirements in 10 CFR 50.47(b) and Appendix E to 10 CFR Part 50 or the requirements in 10 CFR 50.160. Under 10 CFR 50.33(g)(2), an applicant 97

must include the response plans for OROs (such as participating Tribal communities) that are wholly or partially within the plume exposure pathway EPZ. As stated in 10 CFR 50.160(b),

The applicable requirements of § 50.47(a)(1) apply to applications submitted under this section. Section 50.47(a)(1) states that the NRC will not issue an initial OL, COL, or ESP unless a finding is made by the NRC that there is reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency. These protective measures include the response measures described in the offsite response plans.

FEMA reviews these plans and makes a determination of reasonable assurance that adequate offsite protective measures can and will be taken in the event of a radiological emergency. If FEMAs review of a given Tribes emergency plan reveals a deficiency that prevents a finding of reasonable assurance (e.g., lack of dedicated personnel, lack of available resources), the license applicant would need to determine how to address the deficiency noted in FEMAs evaluation of the Tribes emergency plan. This process would include government-to-government consultation involving the Tribes, FEMA, and the NRC, as appropriate.

Even in the case of a site boundary plume exposure pathway EPZ, offsite communities could still develop and maintain emergency response capabilities, including radiological emergency response capabilities, without an NRC requirement for an offsite plume exposure pathway EPZ.

FEMAs CPG-101 provides guidance for developing offsite emergency plans and understanding risk-informed planning and preparedness. FEMAs CPG-201 provides communities with additional guidance for conducting a risk assessment and presents the basic steps of the process. Together, these two CPGs provide resources to OROs and a risk-informed basis for the offsite planning effort, as well as encourage the engagement of the whole community to address risks that might impact a jurisdiction.

Accordingly, the NRC did not change the rule language in response to this comment.

L. Draft Regulatory Guide Comment L-1: Several commenters suggested that the NRC clarify certain definitions or phrases in DG-1350:

a. One commenter requested that the NRC clarify the term Incident Commander as it is used for the first time on page 17 of DG-1350. The commenter explained that it is not clear if this role is related to the role emergency team leader used on page 16 in Section 5.h.4.a-b.
b. One commenter had several suggestions for the Glossary on page 24 of DG-1350:

o In the definition of non-power production or utilization facility, the phrase or 10 CFR 50.22, as applicable, that is not a nuclear power reactor or production facility as defined under should be changed to or 10 CFR 50.22, that is not a nuclear power reactor or production facility, as defined under.

o For the definition of performance-based, the phrase of EP and planning upon the should read of emergency planning upon the.

o Under the definition of site boundary, the phrase (Ref. 20), specifically 20.1003 should be changed to (Ref. 20), Section 20.1003.

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o The definition for technology-inclusive should be clearer, especially in the context of DG-1350.

c. One commenter asked if the term personnel mentioned in the Communications subsection e.(1) on page 13 of DG-1350, as well as subsection f.(1) on page 13 and g.(1) on page 14, means that the personnel should be described by title or position.
d. One commenter requested clarification on when offsite dose projections (on page 21) apply (always or only with an offsite plume exposure pathway EPZ).
e. One commenter mentioned the reference to NRC Management Directive 8.4, Management of Backfitting, Forward Fitting, Issue Finality, and Information Requests, and said that it implies that an applicant or licensee would follow the NRC internal process. The commenter asked if management directives apply to applicants or licensees or are only internal to the NRC.
f. One commenter stated that the title Releases in Subsection C.5.h.(4) on page 16 of DG-1350 may be misleading and that the NRC should change it to Releases to the Environment to clarify that a leak into containment or into another interfacing system is not in the intended scope.
g. One commenter said that Section C.8 on page 22 of DG-1350 should address expectations for identifying common-cause initiating events when analyzing site-specific hazards posed by multireactor modules or units.
h. One commenter suggested that the NRC provided guidance on an acceptable cutoff time for releases discussed in DG-1350, Appendix A, Section A-1.b. For example, the commenter said that the staff has previously determined that 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> is an acceptable cutoff time in approved exemption requests related to EP requirements for decommissioning reactors. Similarly, another commenter noted that the guidance states that an applicant or licensee may demonstrate that protective measures are not required due to timing of releases from a credible accident, but there is no guidance on acceptance criteria or methodology.
i. In relation to Appendix A, Section A-3.1 to DG-1350, one commenter asked the NRC if one bounding release scenario could be selected for the plume exposure pathway EPZ sizing analysis, assuming it could be justified based on PRA results.
j. One commenter suggested that the NRC clarify guidance on identifying and assessing wind sectors within Appendix A to DG-1350.
k. One commenter requested that the NRC expand on the term plume buoyancy in Appendix A, Section A-3.1 of DG-1350 by explicitly stating plume energy and differentiating it from neutral density.

(BM-25, BM-28, DBY-14, DBY-16, DBY-18, NEIA-33, NEIA-38, NEIA-39, NEIA-41, NEIA-42, NSA-9, NSA-12)

NRC Response: The NRC agrees, in part, with the comments.

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a. The term Incident Commander is defined in FEMAs National Incident Management System as an offsite response position, while the emergency team leader position listed on page 16 of DG-1350 is an onsite response position. For added clarity, the NRC added the FEMA definition of Incident Commander to footnote 5 in RG 1.242.
b. The term Non-power production or utilization facility is defined in the NRCs regulations, and guidance cannot change a regulation. The NRC did not change DG-1350 in response to this comment.

The comment provided no basis for the suggested change to the definition of Performance-based. The NRC did not change DG-1350 in response to this comment.

The NRC revised the definition of Site boundary based on this comment. The NRC removed specifically because that word was unnecessary.

The NRC changed the definition of the term Technology-inclusive in DG-1350 based on this comment to clarify that Technology-inclusive means that the requirements are developed so that they apply to more than one technology. The new definition is The principle of establishing performance requirements developed using methods of evaluation that are flexible and practicable for application to a variety of power reactor and NPUF technologies.

c. The term personnel used in Sections C.5.e.(1) and f.(1) of the DG is a generic term used to indicate one or more persons. In the DG, this reference is used for both site employees who may not have an emergency response function and those site employees who are part of the site ERO. The applicants or licensees emergency plan does not need to identify these personnel by title or position. The NRC did not change DG-1350 in response to this comment.
d. The offsite dose projections in Section C.7.g of the DG were included in Section C.7, which provides guidance on the emergency plan description of the required offsite planning activities. Section C.7 of DG-1350 includes a statement that the planning activities listed in Section C.7 are required for only those SMR, non-LWR, and NPUF applicants and licensees who propose a plume exposure pathway EPZ that extends beyond the site boundary. Therefore, the emergency plan for an applicant or licensee with a site boundary plume exposure pathway EPZ does not need to address offsite dose projections as described in Section C.7.g. The NRC did not change DG-1350 in response to this comment.
e. NRC Management Directive 8.4 contains direction to the NRC staff regarding backfitting, forward fitting, and issue finality. It also contains an appeal process on these matters that licensees can use. The NRC did not change DG-1350 in response to this comment.
f. The NRC disagrees with the suggestion to change the title of Section C.5.h.(4),

Releases, in the draft guidance to Releases to the Environment. The heading for this section is based on language used in other NRC documents (e.g., NUREG-0654/

FEMA-REP-1, Revision 2, and NUREG-0396). Although an atmospheric release to the environment is a concern as a final outcome of a potential event, any release, even a controlled release into a containment system, needs to be assessed, monitored, and reported to the emergency team leader as a potential release to the environment. The NRC did not change DG-1350 in response to this comment.

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g. The NRC does not consider common-cause failures as an appropriate initiating event to be identified for a multimodular site-specific hazard analysis. Common-cause failures are broadly defined as the failure of two or more facility components at the same time, or within a short interval, because of a shared cause. Common-cause events are not site-specific hazards posed by multimodular and nuclear units or nearby, adjacent, or contiguous facilities that could complicate the SMRs or ONTs emergency response.

Common cause failure events could happen at any site, so they are not site-specific.

Moreover, the applicant or licensee does not know that components will fail, whereas the hazard analysis looks at hazards that already exist or the applicant or licensee knows will exist (e.g., a chemical plant being constructed contiguous to the SMR or ONT). The NRC did not change DG-1350 in response to this comment.

h. In response to several comments, the NRC revised Appendix A to DG-1350 to add Section A-3.1, Event Selection, in RG 1.242. This new section on event selection includes a discussion on timing considerations but does not suggest a cutoff time.

Rather, Appendix A discusses that an analysis of the timing of the event needs to be performed. Timing of the radiological release to the environment, as justified, may be used to determine whether an accident scenario should be included in the consequence assessment to determine the size of the plume exposure pathway EPZ. Appendix A provides an example of an analysis of timing considerations to show how a previous methodology was used to risk-inform the selection of events warranting predetermined, prompt protective measures. This example, the Low-Power Rule (Emergency Planning and Preparedness Requirements for Nuclear Power Plant Fuel Loading and Low-Power Testing - Final Rule, 53 FR 36955; September 23, 1988), included an analysis on the need for predetermined, prompt protective measures. Due to the substantial reduction in the likelihood of an accident and potential accident consequences for low power testing as compared to continuous full power operation, the analysis for this example identified a time period of 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> (from the start time of the initiating event to the start time of a potential major release) as a reasonable amount of time for OROs to take appropriate response actions that provide for public health and safety without the need for predetermined, prompt protective measures.

i. With respect to the comment on the use of one bounding release scenario, although the proposal to assess one release that bounds the facilitys licensing-basis events is not part of the methodology, it is only one acceptable method, and applicants and licensees are not required to follow it. The applicant or licensee may choose other methods to perform this analysis and provide justification for the specific proposal chosen. The NRC will evaluate each application on a case-by-case basis. The NRC did not change DG-1350 in response to this comment.
j. The NRC revised Sections A-3.3 and A-3.4 of Appendix A to DG-1350 to indicate that applicants and licensees should use wind directions as an additional input parameter for meteorological data during the development of a source transport model. The NRC also revised the DG to indicate that applicants and licensees should identify the approaches for the treatment of wind shifts during the release that were used during the development of the atmospheric transport model.
k. The NRC revised Section A.2.c of Appendix A to expand and clarify plume buoyancy for an atmospheric release as follows:

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The U.S. Nuclear Regulatory Commission developed the guidance in this methodology under the assumption that the atmospheric release may be modeled as a neutral density plume that does not undergo chemical or physical transformations after release to the atmosphere, with corrections for radioactive decay and ingrowth, wet or dry deposition (or both), and plume rise due to buoyancy or momentum (or both), as appropriate. If the chemical or physical form of the atmospheric release requires more complex atmospheric transport modeling, additional analyses may be needed.

Accordingly, the NRC revised DG-1350 as described above.

Comment L-2: Commenters suggested the following editorial changes to DG-1350:

a. Change the phrase authorization for termination and transition to recovery, to authorization for emergency declaration, termination, and transition to recovery, on page 14 of Section C.5.g.(1)(c) of DG-1350.
b. Change the phrase to train and retrain facility personnel on page 14 in Section C.5.g.(2)(a) of DG-1350 to to train and re-train facility personnel and change the phrase within the emergency plan including to read within the emergency plan, including.
c. Change the phrase methods to expand, relax, suspend, or terminate the protective actions to methods to initiate, expand, relax, suspend, or terminate the protective actions in Section C.7.c.(5) of DG-1350.
d. Replace periodicities and periodicity with frequencies and frequency in Section C.7.j.(2) and k.(3) of DG-1350, as the words frequencies and frequency are used on page B-1 of Appendix B.
e. Eliminate the definition of TEDE in Appendix A, Section A-3.5 as the term is already defined in Section A-3.1.
f. Choose to use either 1 rem or one rem for consistency in Appendix A, Section A-1.
g. Change deployment on page 17, Subsection 6.b.(8) to development.
h. Make the note regarding free play following Section C.5.g.(2)(a) a new section as it seems to be missing formatting.
i. Insert to between taken and protect in the first sentence of Section C.7.c, Protective Measures, on page 20 of DG-1350.
j. Revise Section C.5.d to remove the redundant content, such as determining protective actions, and state the expected scope of the protective actions because sentences in Subsections C.5.d.(1) and d.(2) on page 13 of DG-1350 appear to be redundant and unclear.

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k. One commenter pointed out that the references on pages 25 and 26 do not appear to have been reviewed by a technical editor, as they are inconsistent in format and incorrect. The commenter suggested that the NRC include the following edits:

o Item 10: Add Revision 1.

o Item 11: Add Revision 3, March 2007, Section 13.3, Emergency Planning.

o Item 15: Add the document number and revision number for the FEMA NRF, as applicable.

o Item 16: Change EPA-400/R-17/001 to read (something like) U.S. EPA Report No. EPA-400/R-17/001.

o Item 18: Change to read NUREG/CR-7002 (SAND2010-0016P), Criteria for Development of Evacuation Time Estimate Studies, November 2011 (Jones et al.).

l. One commenter suggested that the NRC cite RG 1.233, issued June 2020, which references DG-1350.

(BM-22, BM-23, BM-26, BM-27, BM-29, BM-31, DBY-15, NEIA-36, NSA-27, NEIA-32)

NRC Response: The NRC agrees, in part, with the comments.

a. The NRC revised Section C.5.g.(1)(c) in DG-1350 to add the authorization for making emergency declarations as a responsibility to be considered in the analysis used to determine the minimum positions and corresponding responsibilities to perform the emergency response functions described in the emergency plan. The DG included the responsibilities to authorize termination and transition to recovery but omitted one of the essential roles in the emergency plan: the authorization to make emergency declarations.
b. The NRC revised the second sentence in Section C.5.g.(2)(a) and did not make the changes suggested by the commenter.
c. The NRC added the word initiate to Section C.7.c.(5) in DG-1350 (Section C.8.c.(6) in RG 1.242) because the emergency plan should describe how the organization responsible for issuing protective measures would do so.
d. The NRC made the editorial changes to Section C.7.j.(2) and k.(3) in DG-1350 (Section C.8.i.(2) and 7.f.(3) in RG 1.242) to use consistent terminology.
e. The NRC removed the definition of the abbreviation TEDE in Section A-3.5 of Appendix A to DG-1350 (Section A-3.6 of Appendix A to RG 1.242) because that abbreviation is previously defined in Section A-1 of Appendix A.
f. The NRC changed one rem to 1 rem for consistent style.
g. The NRC changed deployment to development in Section C.6.b.(8) in DG-1350 (Section C.7.b.(8) in RG 1.242) to use the appropriate word.

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h. The NRC added a new subsection, C.5.g.(2)(b), to the Staffing and Operations section in DG-1350 (Section C.6.g.(2)(b) in RG 1.242) to designate the sentence concerning the free play component associated with drill performance that was undesignated in DG-1350.
i. The NRC inserted the word to between taken and protect in the first sentence of Section C.7.c in DG-1350 (Section C.8.c. in RG 1.242) to correct a grammatical error.
j. The NRC agrees with the comment to revise the language in Section C.5.d of DG-1350 (Section C.6.d. in RG 1.242) to provide the capabilities for protective actions examples in a format that follows the format used in other sections of the guidance and to reduce the redundancy noted in the comment. The DG was revised as a result of this comment.
k. The NRC made some of the edits to the references suggested in the comment. The NRC did not make the edits that would have resulted in inconsistent formatting.
l. As stated in the NRC Response to Comment G-7, the NRC added RG 1.233 as an additional reference document in DG-1350. RG 1.233 provides guidance on the selection of licensing-basis events; classification and special treatments of structures, systems, and components; and assessment of defense in depth for non-LWRs.

Applicants can use RG 1.233 in the development of the analysis for determining EPZ size.

Accordingly, the NRC revised DG-1350 as described above.

Comment L-3: Several commenters provided suggestions for defining certain words or phrases:

a. One commenter said that Section A-1.b on page A-1 in Appendix A introduces the concept of an all-hazards emergency management plan and requested that the NRC add a definition or a description of an all-hazards plan, including its content within DG-1350 and the proposed rule.
b. One commenter said that may and minimize within DG-1350 provide no quantitative guidance for the size of the plume exposure pathway EPZ and suggested that either should be defined or replaced with specific quantitative criteria.
c. One commenter suggested that the NRC expand the guidance and define the terms neutral density and non-reactive aerosols for atmospheric release, as the terms can be interpreted differently. The terms are discussed under Appendix A, Section A-2.c on page 28 of DG-1350.
d. One commenter pointed out that the terms DBA and BDBA in the appendices are not quantitatively defined in terms of probability or annual frequency of exceedance. The commenter suggested that the NRC provide detailed guidance on the basis for DBA and BDBA selection. For example, the commenter suggested that DBA could be >1E-6 per year and a BDBA could be >1E-7 per year.
e. One commenter said that the phrase as realistic as possible in Section B-5 in Appendix B to DG-1350 could be interpreted differently by NRC reviewers. The 104

commenter suggested that the NRC revise B-5 to specifically and definitively quantify a definition for the term as realistic as possible and cite NRC references such as State-of-the-Art Reactor Consequence Analyses (SOARCA).

f. One commenter said that the phrases sufficient safety margins and all significant radionuclide sources within Section B-2 in Appendix B to DG-1350 are open to considerable interpretation by NRC reviewers. The commenter suggested that the NRC quantify or provide specific references to NRC documentation to provide context for these phrases. For example, the commenter said that a sufficient safety margin is one that has been previously established by industry codes or NRC precedent, and a significant radionuclide source can potentially affect calculated dose by more than 1 percent.
g. One commenter said that the NRC needs to expand the definition of ONTs as it is too narrow and restrictive. The commenter suggested that the NRC develop footnote 1 on page 6 of DG-1350 to include licensing under 10 CFR Part 52 and add other non-electric power production purposes.

(BM-30, NSA-8, NSA-11, NSA-13, NSA-15, NSA-16, NSA-17)

NRC Response: The NRC agrees, in part, with the comments.

a. In Section A-1.b of Appendix A to DG-1350, the NRC referred to an all-hazards emergency management plan to describe a scenario in which certain actions could be initiated (i.e., the use of an all-hazards emergency management plan) following a radiological release but before the need for evacuation or sheltering, such that the accident resulting in that release could be excluded from consideration in determining the size of the plume exposure pathway EPZ. The NRC revised DG-1350 to remove the reference to an all-hazards emergency management plan.
b. The NRC disagrees with the comment concerning the use of the terms may and minimize in relation to the EPZ sizing methodology. These terms are used as a general description of the more specific (yet still high level) guidance in Appendix A. The NRC did not change DG-1350 in response to this comment.
c. The NRC revised Section A-2.c of Appendix A to DG-1350 to describe neutral density and its transformation process following its release to the atmosphere and removed reference to nonreactive aerosols and gasses.
d. The NRC disagrees with the comment requesting that DG-1350 provide detailed guidance on the basis for DBA and BDBA selection. This DG provides generalized methodologies for determining plume exposure pathway EPZ size and information on source terms related to EPZ size development, which assumes that adequate information on licensing-basis events, radiological source terms, and, as appropriate, PRA is available as part of the applicants license application. The NRCs review of licensing-basis events, including DBAs and BDBAs, is part of the NRCs SAR evaluation.

Therefore, detailed guidance on the basis for DBA and BDBA selection is beyond the scope of this DG. The NRC did not change DG-1350 in response to this comment.

e. The NRC disagrees with the comment that it should quantify a definition for the phrase as realistic as possible in Section B-5 in Appendix B to DG-1350. The phrase as 105

realistic as possible is determined through engineering judgment (for both the NRC and the applicant) and provides flexibility to the applicant to use the information available to it for its particular plant and justify its specific use of the information, including consideration of uncertainty. The NRC did not change DG-1350 in response to this comment.

f. The NRC disagrees with the comment that it should quantify or provide specific references to NRC documentation to provide context for the phrases, sufficient safety margins and all significant radionuclide sources, in Section B-2 of DG-1350. These phrases are items that ensure an integrated risk-informed decisionmaking process.

Maintaining sufficient safety margins in a plants licensing basis is a key principle in risk-informed decisionmaking, as discussed in more detail in RG 1.174, An Approach for Using Probabilistic Risk Assessment in Risk-Informed Decisions on Plant-Specific Changes to the Licensing Basis. To ensure a complete evaluation and comparison to the relevant metric, radiological consequence analyses should include all sources that would significantly affect the results of the analyses. The determination of sufficient safety margin and whether all significant radionuclide sources have been included is related to the consideration of uncertainty in the radiological consequence analyses, in that there is sufficient margin to account for uncertainty in the analyses and data, and the results take into account significant radionuclide sources in order to reduce uncertainty. The NRC will evaluate each applicants analysis on its own merits. The NRC did not change DG-1350 in response to this comment.

g. The NRC expanded footnote 1 in RG 1.242 to explain the scope of the term other new technologies consistent with the explanation in the final rule FRN.

Accordingly, the NRC revised DG-1350 as described above.

Comment L-4: Two commenters requested clarification of the EAL scheme. One commenter asked for clarity on expectations regarding State and local review of the EAL scheme and NRC approval.

The other commenter requested clarification of multiple EAL scheme issues. First, the commenter suggested that the NRC ensures that the example EAL scheme in Table 1 on page 12 is viewed as just one possible scheme and that the reactor design-specifics are the final determination of the actual EAL structure and content. The commenter explained that the proposed rule acknowledges that some reactor designs may employ a non-traditional containment approach which would conflict with the containment barrier EAL example in Table 1.

Second, the commenter noted that DG-1350 does not mention existing industry EAL guidance and suggested that the NRC include a statement in DG-1350 similar to Should elements of existing NRC-endorsed EAL guidance be applicable to the SMR/ONT design, these elements may be used in the development of the site-specific EALs.

Finally, the commenter requested that the NRC clarify that, in Table 1 on page 12, the radiation monitors to be included in EALs are only those associated with detecting and monitoring a radiological release from the facility. The commenter went on to say that radiation monitors not associated with detecting and monitoring radiological release such as those upstream, or located in internal areas and processes need not be included, unless the licensee wishes to 106

credit them as alternative methods to detect and monitor a release in the event an effluent monitor is unavailable. (DBY-13, NEIA-29, NEIA-30, NEIA-31)

NRC Response: The NRC agrees, in part, with the comments. The NRC inserted a new Section C.5.c.(3)(b) in DG-1350 (Section C.6.c.(3)(b) in RG 1.242) to clarify that the applicant or licensee should consider guidance provided or endorsed by the NRC for initial EAL scheme development. The NRC inserted into Section C.7.f.3 in RG 1.242 that the EAL scheme should be reviewed annually with any offsite organization that may have emergency response responsibilities, if applicable. There is no requirement in the final rule for prior ORO agreement of EALs.

The NRC revised Section C.5.c.(3)(c) in DG-1350 (Section C.6.c.(3)(d) in RG 1.242) to indicate that the example EALs listed in Table 1 in RG 1.242 are only one example of EALs that could be used by an applicant or licensee, and they can develop other EALs for submittal to the NRC.

The NRC did not make any revisions to the examples provided in Table 1 associated with radiation monitors (effluents) because these are listed as one example of monitors that can be used by applicants and licensees as deemed appropriate by the applicant and licensee.

Table 1 is guidance and does not establish a requirement of monitors that must be used.

Accordingly, the NRC revised DG-1350 as described above.

Comment L-5: Two commenters noted that the reference to NUREG-0654/FEMA-REP-1 only includes the November 1980 revision. Both commenters suggested that the NRC include a reference to a more recent revision, such as Revision 2, issued December 2019. One commenter asked if, by referencing the 1980 version, it is the NRCs intent to exclude all later supplements and revisions from the guidance. (DBY-9, NSA-19)

NRC Response: The NRC agrees with the comments. The NRC and FEMA revised and published NUREG-0654/FEMA-REP-1, Revision 2, in December 2019. The NRC added Revision 2 as an additional guidance document available for use in support of RG 1.242.

Accordingly, the NRC revised DG-1350 to include a reference to NUREG-0654/FEMA-REP-1, Revision 2, in response to these comments.

Comment L-6: Under Appendix B-2 to DG-1350, one commenter asked if there are other acceptable approaches to identifying the spectrum of credible accidents in addition to the guidance in RG 1.174. (NEIA-44)

NRC Response: DG-1350 states the following:

The NRC issues RGs to describe to the public methods that the staff considers acceptable for use in implementing specific parts of the agencys regulations.

Methods and solutions that differ from those set forth in RGs will be deemed acceptable if they provide a basis for the findings required for the issuance or continuance of a permit or license by the Commission.

Thus, applicants and licensees can propose for NRC review methods other than the approach described in RG 1.174.

Accordingly, the NRC did not change the guidance in response to this comment.

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Comment L-7: One commenter suggested defining the term credible accidents, which is mentioned on page 7 and page A-1 of DG-1350. The commenter explained that, without a clear understanding of how the term is defined, identified, or determined, the whole basis of this proposed rule is weak and subject to interpretation and confusion in the future. One commenter recommended that the NRC should define the term credible hazard on page 11 in Subsection C.5.c.(3)(b) and page 22 in Subsection 8 of DG-1350. (DBY-10, DBY-12, DBY-17)

NRC Response: The NRC disagrees with the comments. As explained in the NRC Response to Comment D-2.1, the NRC removed the term credible accident from the final rule.

Consequently, the NRC removed that term from DG-1350. The NRC did not define the term credible hazard, as described in the NRC Responses to Comments C-1.1 and C-1.2.

Accordingly, the NRC did not change the guidance in response to these comments.

Comment L-8: One commenter noted that hazardous chemicals are mentioned on page 16 of DG-1350 with a reference to 10 CFR 70.4. The commenter explained that EP rules and guidance pertain to radiological hazards; therefore, the NRC should explain the context of the term hazardous chemicals in relation to how it is addressed in DG-1350 and define the term as well. (BM-24)

NRC Response: The NRC disagrees with the comment. The draft guidance document does pertain to radiological hazards. Radioactive fission products exist in a variety of physical and chemical forms that would need to be considered during a radiological release. The release of certain hazardous chemicals produced from licensed material that could be toxic, explosive, flammable, corrosive, or reactive can endanger life and health and impact the response to an incident at a site. Therefore, these chemicals, if released, would need to be monitored and controlled by the licensee to minimize any impact to life or health of emergency responders. For example, Section 13b, Radioisotope Production Facility Accident Analyses, of Interim Staff Guidance Augmenting NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: Format and Content, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors, dated October 17, 2012 (ADAMS Accession No. ML12156A069), includes a Section 13b.3, Analyses of Accidents with Hazardous Chemicals, that provides that a radioisotope production facility license application should include [a] conclusion that the applicant has reasonable assurance that measures to mitigate the consequences of accidents [with hazardous chemicals] are consistent with actions described in the emergency plan.

Accordingly, the NRC did not change the guidance in response to this comment.

Comment L-9: One commenter suggested that the second paragraph under Performance-Based Framework on page 10 of DG-1350 does not provide clear guidance for the application of what the NRC may find acceptable, nor does it provide the NRC reviewer with an acceptable framework. (DBY-11)

NRC Response: The NRC disagrees with the comment. As stated in the guidance, The staff will evaluate applications using a graded approach based on site-specific consequence analyses. As noted in DG-1350, the performance-based framework of 10 CFR 50.160 and anticipated variances in SMR and ONT designs mean that the methods applicants and licensees will need to demonstrate compliance with the applicable EP requirements will vary based on design- and site-specific considerations. Therefore, in RG 1.242, the NRC is providing general guidance on the content of emergency plans. If design-specific guidance is 108

developed by the NRC or industry at a future date, applicants may reference those documents within their applications.

Accordingly, the NRC did not change the guidance in response to this comment.

Comment L-10: One commenter recommended that the NRC revise the Reentry section on page 16 of DG-1350. The commenter suggested that Section C.5.i.(1) should be revised so it reads capabilities to develop and implement reentry plans for access to the facility after radiological emergencies including the methods and a new Section C.5.i.(3) should be added that reads if applicable, capability to develop and implement coordinated reentry plans after hostile action-based emergencies including. The commenter stated that the reentry after hostile action-based events would be coordinated with site security, offsite supporting organizations, or both, which would be consistent with Subsection C.6.b.(7). (NEIA-34)

NRC Response: The NRC agrees with the comment. The capabilities for reentry following a hostile action-based emergency should be coordinated with site security and the Incident Command Post, if applicable. This coordination would not be necessary for reentry plans following a radiological emergency. Therefore, the NRC separated the reentry provisions for radiological emergencies and hostile-action-based emergencies in RG 1.242.

Accordingly, the NRC revised DG-1350 so that Section C.6.i. of RG 1.242 reads as follows:

(1) capabilities to develop and implement reentry plans for access to the facility after radiological emergencies, including the methods, processes, equipment, facilities, and personnel; (2) capabilities to develop and implement reentry plans for access to the facility following hostile action-based emergencies including the methods, processes, equipment, facilities, and personnel in coordination with site security and the Incident Command Post (ICP), if applicable .

Comment L-11: One commenter suggested that bullet 2, Evaluated Exercises, under Section C.5.g.(2)(a) of DG-1350 should be moved since exercises are not drills and should be replaced with a new Section C.5.g.(3), which reads as follows:

Evaluated exercises are used to demonstrate proficiency in the major portions of the emergency plan and, as such, cannot be used for training and instruction.

Participation in an evaluated exercise is not required in advance of being assigned to an emergency response role. (NEIA-35)

NRC Response: The NRC agrees with the comment. The discussion in DG-1350 of evaluated exercises should not be in the same section that describes the various types of drills used for training. The NRC moved the discussion of evaluated exercises to a new Section C.6.g.(2)(c) in RG 1.242 that defines the purpose of evaluated exercises and explains how they differ from the drills listed in Section C.6.g.(2)(a).

Accordingly, the NRC revised DG-1350 in response to this comment.

Comment L-12: One commenter suggested that guidance provided in Appendix A, Section A-2 to DG-1350 should also permit consideration of factors mitigating an atmospheric radiological release. The commenter explained that many advanced reactor designs include subterranean reactor vessels and support systems, which would result in greater particulate removal than is currently recognized in guidance. (NEIA-40) 109

NRC Response: The NRC disagrees with the comment. Consideration of factors that would affect the release to the atmosphere such as particulate removal in subterranean areas of the facility is part of the source term development, which should model the transport of fission products across all barriers and pathways to the environs. The NRC provides high-level guidance on the development of source terms in Appendix B to RG 1.242.

Accordingly, the NRC did not change the guidance in response to this comment.

Comment L-13: One commenter suggested that dose aggregation guidance in Appendix A, Section A-3.6 would benefit from the addition of an acceptable limiting dose exceedance frequency or identifying sources of an acceptable frequency. (NEIA-43)

NRC Response: The NRC agrees with the comment. Applicants and licensees would benefit from additional guidance on an acceptable dose exceedance frequency. The NRC revised Appendix A Section A-3.6, Probabilistic Dose Aggregation, of DG-1350 (Appendix A, Section A-3.7 in RG 1.242) to state that the likelihood of exceeding a TEDE of 1 rem at the proposed EPZ boundary should be consistent with the evaluation in Appendix I to NUREG-0396, and to identify relevant information from NUREG-0396 that may be used by applicants and licensees to inform selection of a limiting dose exceedance frequency to inform the size of the plume exposure pathway EPZ.

Accordingly, the NRC revised DG-1350 in response to this comment.

Comment L-14: In relation to Appendix A, Section A-3.1 and Appendix B, Section B-5, one commenter asked if it is acceptable to use source terms that reflect a hybrid approach of deterministic and probabilistic considerations. The commenter said that this approach may be helpful to some applications dealing with large uncertainties in their PRA models. (NEIA-45)

NRC Response: The NRC agrees, in part, with the comment. The NRC agrees that an applicant is not required to use a mechanistic source term for the dose analysis to support plume exposure pathway EPZ size determination. As stated in Appendix B to RG 1.242, each applicant should develop potential source terms from accidents for its facility. Applicants can use the same methods in the analysis to support plume exposure pathway EPZ size determination that they use in the safety analysis for the license application. The NRC review of accident source terms is part of the safety review for the license application and supports its separate review of the applicants emergency plans. However, the NRC is not commenting on whether a hybrid approach could be useful to certain applicants and not providing detailed guidance on other potential approaches to develop accident source terms. An RG provides one acceptable approach, and applicants can propose a different method for NRC review.

Accordingly, the NRC did not change the guidance in response to this comment.

Comment L-15: One commenter suggested that the NRC revise item e under Appendix A, Section A-2 to state that one 96-hour exposure with no protective action credit shall be assumed, as the assumption of a specified exposure duration with no protective action credit contradicts the introduction paragraph in Section A-1. (NSA-10)

NRC Response: The NRC agrees with the comment. To be consistent with the introductory paragraph in Appendix A, Section A-1 of DG-1350, Section A-2.e should be clarified to state that the exposure duration should be 96 hours0.00111 days <br />0.0267 hours <br />1.587302e-4 weeks <br />3.6528e-5 months <br />. In addition, no credit for protective actions 110

should be assumed in the analysis to ensure that the plume exposure pathway EPZ encompasses areas where prompt protective measures are necessary.

Accordingly, the NRC revised Appendix A, Section A-2.e in DG-1350 to clearly state that an exposure duration of 96 hours0.00111 days <br />0.0267 hours <br />1.587302e-4 weeks <br />3.6528e-5 months <br /> from the start of the release with no credit for protective actions should be assumed.

Comment L-16: One commenter discussed the statement on modeling fission product transfer across all barriers and pathways to the environment. The commenter recommended that this section be expanded to state that credit for nonsafety-related structures, systems, and components is acceptable for BDBAs. The commenter also suggested that the NRC define the term transport in a footnote that includes the physical movement as well as the natural processes of FP depletion including, but not limited to, gravitational settling, diffusiophoresis, thermophoresis, spray depletion, and chemical reactions. (NSA-14)

NRC Response: The NRC agrees with the comment. Additional clarity could be added on modeling fission product transport to be consistent with current practice and regulatory guidance on radiological consequences of DBAs in NUREG-0800, Section 15.0.3, Design Basis Accident Radiological Consequences of Analyses for Advanced Light Water Reactors, issued March 2007 (ADAMS Accession No. ML070230012), and RG 1.183, Alternative Radiological Source Terms for Evaluating Design Basis Accidents at Nuclear Power Reactors, issued July 2000 (ADAMS Accession No. ML003716792), and the discussion for non-LWR determination of licensing-basis events in RG 1.233. The NRC revised Appendix B, Section B-4, to DG-1350 to explain that the evaluation of DBAs should assume only safety-related structures, systems, and components are available to mitigate the accident.

Consistent with modeling practices for severe accident analysis and PRA, beyond-design-basis events may model structures, systems, and components according to their capability under the plant conditions for the event. The NRC also added a footnote to DG-1350 to clarify what is meant by transport of fission products as suggested in the comment.

Accordingly, the NRC changed Appendix B to DG-1350 in response to this comment.

Comment L-17: One commenter stated that Section B in DG-1350 does not definitively state whether this guidance fully complies with IAEA general safety requirements (GSR) Part 7. The commenter suggested that the NRC add a summary or conclusion that clarifies this. (NSA-18)

NRC Response: The NRC agrees, in part, with the comment. DG-1350 does not definitively state whether DG-1350 fully complies with IAEA GSR Part 7. There is no requirement for NRC guidance documents to comply with IAEA guidance documents.

The section of GSR Part 7 entitled Application of the Safety Requirements provides the basis as to why the document is not binding on the NRC. It states, in part, the following:

These safety requirements are to be applied by the Sponsoring Organizations to their own operations in line with their respective mandates. States that are member states of the Sponsoring Organizations other than the IAEA may adopt these safety requirements, at their own discretion, or in accordance with their membership obligations, for application to their own activities.

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The NRC is a member state of IAEA, a Sponsoring Organization. Based on GSR Part 7s applicability, the NRC considered GSR Part 7 and utilized discretion in adoption of its safety standards during the development of DG-1350.

The NRC revised the Harmonization with International Standards section of DG-1350 consistent with standard changes the NRC makes to new or revised RGs, but the NRC did not change DG-1350 in response to this comment.

Comment L-18: One commenter said that the scope and intent of the hazard analysis requirement in Section C of DG-1350 is unclear. The commenter said Section C also provides little guidance on how to conduct a hazard analysis, or its relationship with associated regulations and guidance. (NSA-23)

NRC Response: The NRC agrees, in part, with the comment. RG 1.242 provides high-level guidance on the means of conducting the hazard analysis. As explained in Section C.5 of DG-1350, the NRC is providing general guidance on the content of emergency plans but not specific methods for compliance: The methods needed to demonstrate preparedness will vary based on design- and site-specific considerations. Each hazard analysis supporting the method for compliance will also be site specific. The SOC for the final rule contains additional information related to the hazard analysis.

Accordingly, the NRC did not change the guidance in response to this comment.

Comment L-19: One commenter said that advanced reactor designs could address performance-based requirements in the rule differently and the associated guidance should reflect this. As an example, the commenter referred to concerns related to events that impact multiple reactor modules in one location and noted that guidance should address EP for multiple reactor modules. (CLA-3)

NRC Response: The NRC agrees with the comment. The guidance document is written to support a performance-based framework for a variety of reactor technologies, as its title indicates. Thus, different applicants could propose to address the requirements in 10 CFR 50.160 in different ways. Further, the final rule requires that applicants and licensees account for multiple reactors at a single site, as described in the NRC Response to Comment C-1.4. As explained in Section C.9.a of RG 1.242, the hazard analysis should include the site-specific hazards posed by multimodular and nuclear units and nearby, adjacent, or contiguous facilities that could complicate the licensees emergency response.

Accordingly, the NRC did not change the guidance in response to this comment.

Comment L-20: One commenter noted that RG 1.242 does not specify new performance indicators beyond those used for LLWRs, and current requirements under 10 CFR 50.47 have largely been rewritten and reproduced in the proposed rule and guidance. The commenter stated that the proposed rule introduces a second set of planning standards for facilities with an offsite plume exposure pathway EPZ. The commenter suggested that the two sets of planning standards (i.e., 10 CFR 50.160 and 10 CFR 50.47) could cause confusion across the stakeholder community. (CRCPD-9)

NRC Response: The NRC disagrees with the comment. The final rule clearly states that applicants and licensees must use either the EP framework of 10 CFR 50.47(b) and Appendix E to 10 CFR Part 50 or the requirements in 10 CFR 50.160. Performance indicators are part of 112

the NRCs oversight and inspection program and will be developed in the future for SMRs and ONTs.

Accordingly, the NRC did not change the guidance in response to this comment.

Comment L-21: One commenter stated that the final RG should clarify that the facilities required by 10 CFR 50.160(b)(1)(iv)(A)(4) and 10 CFR 50.160(b)(1)(iv)(B)(6) may be collocated with a facility serving another purpose. (NEIA-9)

NRC Response: The NRC disagrees with the comment. The emergency response facilities required by 10 CFR 50.160(b)(1)(iv)(A)(4) and 10 CFR 50.160(b)(1)(iv)(B)(5) (formerly 10 CFR 50.160(b)(1)(iv)(B)(6) in the proposed rule) will be site-specific, design-specific, or both.

The guidance allows for a range of designs based on these site-specific and design-specific criteria. Collocation of the emergency response facilities with a facility serving another purpose is one possible scenario, but the NRC did not include in RG 1.242 examples of the types of facilities that could satisfy the requirements of 10 CFR 50.160(b)(1)(iv)(A)(4) and 10 CFR 50.160(b)(1)(iv)(B)(5).

Accordingly, the NRC did not change the guidance in response to this comment.

M. Requests for Extension of the Comment Period Comment M-1: Several commenters, and a form letter campaign, recommended a 6-month extension of the comment period, citing the complexity and significant impacts of the proposed rule. One commenter wrote that the extension would have a positive impact on the quality of the comments. Additionally, some commenters, including a form letter campaign, cited the COVID-19 pandemic as a rationale for extending the comment period by 6 months or 6 months after the COVID-19 crisis is over. One commenter said that there is not an urgent and immediate need for the proposed rule. The commenter also wrote that communities of color, who face structural racism related to proximity to and the impact of nuclear power plants, have been disproportionately impacted by the pandemic and may not have the time or resources to comment on the rule. (SL1-1, PL-1, UW1-1, UW1-3, SL2-1, GW-1, NGO-1, FL1-2)

NRC Response: The NRC agrees, in part, with the comments. The NRC seeks to ensure that the public and other stakeholders have a reasonable opportunity to provide the NRC with comments. The NRC acknowledges that the rulemaking documents contain a significant amount of information. However, the NRC disagrees that a 6-month extension was warranted in this case.

Accordingly, the NRC extended the comment period for the proposed rule for an additional 60 days, which provided a reasonable opportunity for all stakeholders to review these documents and to develop informed comments on these documents. The public comment period was originally scheduled to close on July 27, 2020, and the NRC extended the comment period for an additional 60 days to September 25, 2020.

Comment M-2: Commenters requested that the comment period be extended because additional information is needed on the design, safety, and risks of SMR reactor designs, and will become available after the end of the comment period. Specifically, the commenters referred to the proposed NuScale Power LLC SMR design, which is the first multimodule SMR design to be considered by the NRC. The commenter noted that the NRC and Advisory Committee on Reactor Safeguards (ACRS) review of the proposed projects application is 113

relevant to the rulemaking but will not be final by the time the comment period concludes.

(UW1-2, NGO-2)

NRC Response: The NRC agrees, in part, with the comments. The NRC extended the original public comment period to allow more time for members of the public and other stakeholders to develop and submit their comments. The public comment period was originally scheduled to close on July 27, 2020, and the NRC extended the comment period to September 25, 2020.

But the NRC disagrees that the comment period needed to be extended for the availability of additional information on reactor designs because the final rule is technology inclusive. Thus, the NRCs completion of this rulemaking does not depend on the design of any SMR or ONT.

N. Additional Comments on the Proposed Rule Comment N-1: Two commenters expressed opposition to FEMAs comments on the proposed rule that suggest congressional action may be necessary for the NRC to finalize this rulemaking due to alterations to the consultative relationship between FEMA and NRC. The commenters explained that, under the AEA, the NRC has the authority to create regulations that protect the health and safety of the public and said that the proposed rule fits within this authority. One commenter discussed the relationship between the NRC and FEMA, and stated that Congress, through language in NRC Authorization Acts, and the U.S. Courts of Appeals have recognized that the NRC has the final authority regarding whether an applicant or licensee has provided reasonable assurance that adequate protective measures will be implemented in the case of a radiological emergency. The commenters explained that this responsibility is essential as it avoids unnecessary and inefficient dual regulation by multiple Federal agencies.

The commenters stated that for facilities with a plume exposure pathway EPZ that extends beyond the site boundary, NRC and FEMA coordination on this rules offsite EP planning requirements would remain unchanged. According to the commenters, the rule also explains that facilities with a site boundary plume exposure pathway EPZ do not affect FEMAs responsibility for overall emergency management in providing assistance to State and local governments, nor does it impact the emergency management responsibilities of State and local governments. As a result, the proposed rule does not involve a matter of significant public policy that would require congressional action.

One commenter also highlighted the history of the proposed rulemaking, stating that the Commission, noting the need for regulations that meet the needs of advanced reactors and reduce the need for exemptions, unanimously initiated the rulemaking in 2015. Soon after, the Tennessee Valley Authority submitted an ESP application requesting a 2-mile plume exposure pathway EPZ option. The NRC staff conducted a technical review of the application and addressed FEMAs concerns at that time related to the proposed scalable emergency planning approach. Ultimately the Commission issued the ESP and noted that the NRC staffs responses addressed FEMAs concerns. (NEICL-1, NEICL-2, NEICL-3, NEICL-4, NEICL-5, CLA-6, CLA-7, CLA-8, CLA-9)

NRC Response: The NRC agrees with the comments. As explained in the proposed rule FRN, the NRC has the congressional authority under the AEA to establish standards for both onsite and offsite radiological emergency response plans and for making licensing decisions regarding the overall adequacy of EP for a nuclear power plant site. This rulemaking is conducted within this authority.

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The NRC also agrees that this rulemaking does not seek to alter the consultative relationship between the NRC and FEMA. When a plume exposure pathway EPZ extends beyond the licensees site boundary, the NRC consults with FEMA on offsite radiological EP. This rulemaking does not change that relationship. The NRC Response to Comment N-7 discusses in more detail the consultative relationship between the NRC and FEMA as it relates to offsite emergency planning.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment N-2: Several commenters stated that the proposed rule is consistent with the Nuclear Energy Innovation and Modernization Act (NEIMA) and abides by its requirements.

The commenters stated that NEIMA directed the NRC to establish a risk-informed, technology-inclusive framework to license and oversee advanced nuclear technologies.

One commenter further stated that NEIMA instructed the NRC to submit a report on EP enhancement activities. The commenter wrote that the report anticipated that future advanced reactor designs would require different EP requirements than the current fleet of LLWRs, and the NRC would need to develop new EP requirements to reduce the reliance on exemption requests. (NEICL-6, NSCL-2, CLA-5, NNSA2-2, ANS-3)

NRC Response: The NRC agrees with the comments. The comments support the proposed rule and suggest no changes to the proposed rule.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment N-3: Several commenters asserted that the assumptions used by the NRC to evaluate the safety of SMR and ONT designs are not supported by any evidence. One commenter said that there is no basis for the assumption that SMR and ONT designs are inherently safer, have lower risk, and have less demanding accident conditions. This commenter said that the proposed rule does not adequately consider a number of risks associated with new technologies and SMRs. The commenter further stated that the NRC should not make any assumptions regarding reactor safety until there has been a period of operational experience. Another commenter further said that unreconciled weaknesses in SMR design and performance make it impossible for the NRC to reach any conclusion regarding the safety of SMRs. The commenters offered NuScales SMR design as an example. (SRA-5, SRA-6, SRA-7, SRA-8, SRA-9, UW2-12, UW2-18, UW2-38, UW2-40, UW2-42)

NRC Response: The NRC disagrees with the comments. Based on experiences to date, such as the Clinch River ESP and preapplication discussions, the NRC expects SMR and ONT facilities to have smaller reactor core sizes, lower power densities, reduced likelihood of severe accidents, slower accident progression, and reduced likelihood of accident offsite consequences. With the expected safety enhancements in SMR designs, the NRC is allowing SMR applicants to develop plume exposure pathway EPZ sizes commensurate with their accident source terms, fission product releases, and accident dose characteristics.

To meet the requirements of this rulemakings performance-based, technology-inclusive, risk-informed, and consequence-oriented EP framework, each applicant will need to demonstrate these safety enhancements for its design. Additionally, as explained in the NRC Response to Comment A-2.2, under 10 CFR 50.43(e), the NRC requires the demonstration of the performance of safety features of new reactor designs before approving the designs. The 115

NRC Response to Comment N-6 discusses in more detail the safety enhancements expected in SMR and ONT facilities.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment N-4: Several commenters, including a form letter campaign, stated that nuclear reactors are a low risk technology that can mitigate climate change and air pollution. One commenter and a form letter campaign said that advanced nuclear reactors are clean, non-CO2 emitting power sources that can benefit the fight against climate change. The form letter campaign asserted that advanced nuclear reactors have numerous environmental benefits, such as replacing fossil fuel power plants, and that it is imperative they are not hindered by unnecessary regulations. One commenter said that evidence suggests countries with sources of nuclear energy have fewer public health issues from air pollution. Another commenter stated that nuclear technology has its drawbacks like any technology, but ultimately, it is one of the safest forms of electricity production. The commenter added that the total deaths and lasting injuries associated with major accidents such as Chernobyl, Three Mile Island, and Fukushima have been very low. Also, the commenter stated that this rulemaking is a step in the right direction to give the nuclear power industry the regulatory framework needed to balance technological advancement with a continuing expectation of safety for both people and the environment. Finally, the commenter asserted that relative to other renewable energy sources such as wind, solar, or hydropower, nuclear energy can produce the same amount of energy with a smaller land use footprint. (NR-6, RB-1, FL2-5)

NRC Response: The NRC agrees, in part, with the comments. The NRC agrees that it should proceed with the rulemaking. However, the promotion of nuclear power, for any reason, is not one of the purposes of this rulemaking nor is it permissible under the NRCs statutory authority.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment N-5: One commenter asked the NRC to incorporate and consider multiple statements from FEMA; statements by Commissioner Baran; and the ACRS NuScale SMR DC Lessons Learned Letter Report, dated October 2, 2020 (ADAMS Accession No. ML20267A655).

Regarding letters from FEMA, the commenter said that the July 8, 2019, FEMA letter (ADAMS Accession No. ML19189A318) directly applies to this rulemaking and that FEMA should be the primary responsible entity that the NRC relies on because of FEMAs knowledge and expertise.

The commenter further said that the August 24, 2019, FEMA letter (ADAMS Accession No. ML19240A938) applies to this rulemaking and that the NRC must respond to all of the letters concerns as a part of the rulemaking. (UW2-3, UW2-4, UW2-5, UW2-6)

NRC Response: The NRC agrees, in part, with the comments. The NRC has incorporated into the commenters submission FEMAs July 8, 2019, letter regarding the Clinch River ESP application; FEMAs August 24, 2019, letter regarding testimony at the Clinch River ESP hearing; and the separate views of NRC Commissioner Baran included in the proposed rule FRN. The NRC responds to the content of these specific comments in other NRC responses to comments in this document. However, the NRC disagrees that it must consider the ACRS NuScale SMR DC Lessons Learned Letter. The ACRSs recommendations are for advanced reactor design reviews, whereas the final rule establishes a technology-inclusive EP framework for the regulation of SMRs and ONTs. Thus, the NRCs completion of this rulemaking does not depend on the design of any SMR or ONT. Further, the ACRS letter did not discuss the topic of this rulemakingEP.

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Accordingly, the NRC did not change the rule language in response to these comments requesting the incorporation of other stakeholders statements and letters.

Comment N-6: One commenter asked for specific evidence for some of the claims presented in the proposed rule. First, the commenter said that the proposed rule references advances in designs and safety research and their application to future operation of SMRs and ONTs but does not provide any information on what these advances are. The commenter wrote that the NRC should conduct a full technical study and risk analysis of the specific designs to which the proposed rule would apply. Second, the commenter wrote that the proposed rule indicates that the new EP requirements would recognize advances in design and technological advancements embedded in design features. The commenter asked that the NRC specifically reference these advancements and added that risks, potential problems during reactor operation, and any other aspect of the reactor that could lead to accidents and offsite radiological releases and exposure to the public be considered. Finally, the commenter wrote that the proposed rule indicates that new EP requirements would credit safety enhancements in evolutionary and passive systems but asked the NRC to detail what these safety enhancements are and how they will be balanced with a lack of operational history in SMR facilities. (UW2-11, UW2-16, UW2-17)

NRC Response: The NRC disagrees with the comments. SMRs and ONTs are expected to incorporate design and safety enhancements, including inherent passive safety characteristics, below-grade or in-ground construction, natural circulation decay heat removal, interconnected systems, and advanced fuel types. These designs are associated with a potential low likelihood of severe accidents, slower transient response times, and relatively small and slow release of fission products. The final rule assesses and takes into account the smaller reactor core and source terms for these designs, which potentially could provide for lower risk to the public as compared to the risk from LLWRs. For example, locating part or all of the reactor and structures below ground level would result in a ground-level release, which would affect the dispersion of the plume; buried reactor structures and pools may have longer coolant loss times and correspondingly longer accident progression times; and passive safety features that do not depend on electric power also could lead to longer accident progression times. Based on this, the NRC concludes that a graded approach to EP for SMRs and ONTs is appropriate.

Nevertheless, this final rule is technology inclusive. Any SMR or ONT applicant needs to demonstrate that its design meets the NRCs safety standards. As explained in the NRC Response to Comment A-2.2, under 10 CFR 50.43(e), the NRC requires the demonstration of the performance of safety features of new reactor designs before approving the designs.

Whether the applicants emergency plan meets the requirements of the NRCs EP requirements is determined based on inquiries that are both dependent and independent of the NRCs safety reviews. For example, the NRC reviews the applicants assessment of licensing basis events, event likelihood, and public dose consequences as part of the agencys safety review of the application. The NRCs determination of the acceptability of the applicants assessment supports the review of the applicants emergency plan. The NRCs review of the emergency plan is also independent of the safety review, as described in the NRC Responses to Comments D-1.3 and D-2.1. These reviews occur regardless of the reactor design submitted by the applicant.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment N-7: Two commenters stated that the NRC and FEMA have a consultative relationship and that community radiological EP is a shared responsibility between the 117

agencies. One commenter stated that the NRC has the authority, utilizing FEMA input, to determine the relative importance of offsite EP in its licensing decision. The commenter expressed concern that the proposed rule alters this consultative relationship and asserted that this is a matter of significant public policy, which will have to be resolved by Congress. Another commenter echoed the importance of FEMAs determinations in the NRCs licensing process but said that under the proposed rule, FEMA would have no role in assessing offsite emergency plans for reactors with a site boundary plume exposure pathway EPZ. (FEMA-7, UWJB-6)

NRC Response: The NRC agrees, in part, with the comments. The NRC agrees that it has a consultative relationship with FEMA, and the NRC and FEMA executed a memorandum of understanding that outlines the responsibilities of both agencies as they relate to offsite radiological emergency planning.

The NRC disagrees with the comments because, in carrying out its responsibility under the AEA, the NRC establishes regulatory standards for onsite and offsite radiological emergency planning. In the case of EP regulations for non-power reactors, fuel cycle facilities, and independent spent fuel storage facilities, there are no regulatory requirements for dedicated offsite radiological emergency plans as part of the NRC license. Accordingly, NRC guidance for such facilities states that FEMA findings and determinations are not needed to support NRC licensing decisions. Similarly, for SMRs and ONTs, if the NRC determines that reasonable assurance of the adequacy of offsite radiological EP is not required for facilities where plume exposure pathway EPZs do not extend beyond the site boundary, then FEMA findings and determinations regarding reasonable assurance would not be needed.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment N-8: One commenter expressed concern that the NRC has approved only one SMR design, and no SMR facility will become operational until November 2022. As a result, the NRC will not be able to fully assess SMR designs at that time for another 2 years. The commenter said that companies proposing to operate SMR facilities have no history in licensing, constructing, operating, or maintaining nuclear reactors. The commenter asserted that there are aspects of operating the first SMR that will not be known until it is operational, and that it is subsequently irresponsible of the NRC to limit the plume exposure pathway EPZ and reduce emergency planning requirements. The commenter further stated that the NRC has not adequately evaluated the risks of reducing emergency response planning for these new reactor designs. One commenter said that it is reckless of the NRC to ease public safety rules before an SMR design is approved. The commenter wrote that this action is unwarranted and said that the NRC has acknowledged the wide-ranging, unanswered concerns regarding the safety of SMR technology. (SRA-4, UW2-19, UW2-31)

NRC Response: The NRC disagrees with the comments. Despite the lack of operating experience with SMRs and ONTs, the NRC can proceed with this technology-inclusive rule. A technology-inclusive rule means that the rule does not depend on the design of the facility. The NRC accomplishes this by providing a risk-informed, performance-based, consequence-oriented framework, as explained in the NRC Responses to Comments B-1.2, B-3.1, and B-7.1. Nevertheless, as explained in the NRC Response to Comment N-6, any SMR or ONT applicant will need to demonstrate that its facilitys design will meet the NRCs safety standards. The applicant also will need to demonstrate that its emergency plan meets the NRCs EP requirements. Further, if the applicant proposes to comply with this final rule, then the applicant must show that its emergency plan fits within the framework of 10 CFR 50.160.

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This rule does not assume that a licensee complying with the final rule will have a site boundary plume exposure pathway EPZ. The size of the plume exposure pathway EPZ will depend on several factors, as explained in the NRC Response to Comment D-1.3.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment N-9: Two commenters requested clarification of the NRCs definition of SMRs based on their MW(e) generating capacity. One commenter wrote that the proposed rule defines an SMR as equal to or less than 1,000 MW(e) per module while the more common definition is less than or equal to 300 MW(e). The commenter expressed concern that this definition would make the proposed rule applicable to SMRs as well as medium-sized or future de-rated reactors. The commenter requested clarification of why and for what purpose the definition was changed.

Another commenter wrote that under the proposed rules definition, a 12-module SMR facility could have a total output of 3,600 MW(e) (12,000 MW(t)) which is a significant electrical output.

The commenter wrote that the definition of SMR should limit each facility to 1,000 MW(t) total for all modules. (PBRP-1, UW2-49)

NRC Response: The NRC disagrees with the comments. In the proposed rule, the NRCs definition of an SMR is a power reactor that produces heat energy up to 1,000 MW(t), not MW(e). Because electrical power generating capacity is not a criterion the NRC uses to determine EP requirements, the rules definition focuses on thermal power rating. The NRC Response to Comment C-1.4 explains how the final rule requires consideration of each module at a single SMR.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment N-10: Two commenters stated that the proposed rulemaking can benefit electric systems and provide communities with clean, reliable electricity. One commenter stated that advanced reactors can support remote communities and mining operations that need emissions-free, dispatchable electricity. (NIA-4, ANS-2)

NRC Response: The NRC agrees, in part, with the comments. The NRC agrees that it should proceed with the rulemaking. However, the promotion of nuclear power, for any reason, is not one of the purposes of this rulemaking nor is it permissible under the NRCs statutory authority.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment N-11: One commenter urged the NRC to consider Tribes and Tribal lands before and during the rulemaking process. The commenter suggested that the NRC visit Tribal land to develop a better understanding of the local community along with the importance of the land and resources. The commenter further stated that the NRC should identify Tribes and ancestral lands that will experience substantial direct effects from agency actions. The commenter stated that the NRC has a commitment to facilitate Tribal involvement and government-to-government consultation. (NETWG-4, NETWG-5)

NRC Response: The NRC agrees, in part, with the comments. NRC engagement with Tribal communities impacted by the agencys activities is critical. However, this final rule is voluntary, and the NRC does not know which, if any, applicants will use the alternative EP framework of this final rule and whether any Tribes would be affected. The NRC conducted public outreach as described in the NRC Response to Comment N-12, plus the NRC staff gave a presentation 119

on the proposed rule to the Bureau of Indian Affairs Emergency Management Division and Tribal emergency response managers on August 2, 2018 (ADAMS Accession No. ML18292A488); sent a State and Tribal Communications letter to all Federally recognized Tribes, dated October 22, 2018, to provide notice of the upcoming public availability of the draft proposed rule (ADAMS Accession No. ML18284A124 (package)); sent a letter to all Federally recognized Tribes, dated May 21, 2020, to provide notice of the NRCs publication of the proposed rule and request for comments (ADAMS Accession No. ML20066K668 (package));

and gave a presentation to the Nuclear Energy Tribal Working Group on September 1, 2020, on the proposed rule. Going forward, the NRC will engage in outreach and consultation with the Tribes on EP during individual licensing proceedings in accordance with the agencys Tribal Policy Statement and Tribal Protocol Manual.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment N-12: One commenter expressed concern that SMRs and ONTs may be placed in communities that have no knowledge of the proposed rulemaking and no knowledge or experience with reactor operations. The commenter said that these citizens and communities are stakeholders that have not been consulted and are unaware that the rulemaking may affect them. Additionally, the commenter wrote that EP requirements should be changed only in the context of the application process with citizen participation. The commenter further said that the proposed rulemaking will limit, if not eliminate, community participation in decisions related to offsite planning for radiological emergencies. The commenter asserted that the proposed rule eliminates the communitys right to informed consent, along with the communitys right to protect itself from SMRs and ONTs. (UW2-20, UW2-27, UW2-28)

NRC Response: The NRC disagrees with the comments. The NRCs EP regulations are written for use by all applicable licensees. Generic rulemaking is an efficient and open process to address matters that apply to a given category of licensees generically, and it provides opportunities for public input from all interested parties regardless of location. In addition to the opportunities for the public to participate in the generic establishment of the EP regulations, the review of an application for a specific facility includes a hearing process that provides an opportunity for public participation to members of the community where that facility is located.

Members of the public have the opportunity to request a hearing on the proposed emergency plan for that facility. The NRC also provides opportunities for public engagement in communities where facilities are proposed to be located through draft environmental impact statement public scoping meetings and government-to-government meetings.

The NRC has held multiple public meetings as opportunities for members of the public to learn about and ask questions about the rulemaking. The NRC staff held a public meeting on August 22, 2016, to request feedback from interested stakeholders on a potential performance-based approach for EP for SMRs and ONTs. The NRC published a draft regulatory basis for the rulemaking on April 13, 2017, with a 75-day public comment period and held an additional public meeting on May 10, 2017, to provide an overview of the draft regulatory basis. The NRC published the proposed rule with a 75-day public comment period with an additional 60-day extension of the comment period. The NRC staff also held a public meeting on June 24, 2020, to review the proposed rule. Openness is among the NRCs organizational values and Principles of Good Regulation, and it is the NRCs general policy to share information with the public in a transparent manner.

As described in the NRC Response to Comment A-2.3, the level of EP will be the same under the final rule as it is under the current framework in 10 CFR 50.47(b) and Appendix E to 120

10 CFR Part 50, thereby affording the same level of protection of the public health and safety as the current regulatory framework. As described in the NRC Response to Comment B-7.2, communities can develop and maintain radiological response capabilities without an NRC requirement for an offsite plume exposure pathway EPZ. Therefore, this rulemaking does not eliminate a communitys right to protect themselves from SMRs and ONTs. In the AEA, Congress authorized the NRC to regulate the civilian use of radioactive materials. The AEA requires the NRC to provide adequate protection of the public health and safety for communities around nuclear power plants through its regulation of these facilities. The NRC has the statutory authority to establish standards for both onsite and offsite radiological emergency response plans and to make licensing decisions regarding the overall adequacy of EP for a nuclear power plant site. This rulemaking is conducted within this authority.

Regarding the comments suggestion to change the EP requirements in the context of an application process, the NRC does not make generic changes to regulations in the context of reviewing a specific application. Using such an approach in this case would potentially change the EP requirements with every SMR and ONT license application, perhaps repeatedly, and would make licensing proceedings unreasonably inefficient and complex. The rulemaking process is more appropriate for making generic changes, and it is open to the entire public. The licensing process is more appropriate for evaluating the EP approach taken at a specific site, and members of the local communities have opportunities to participate in that process.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment N-13: One commenter stated that the United States has experienced a number of recent extreme emergencies (wildfires, hurricanes, and COVID-19) and that the lack of EP caused significant harm to public health, public safety, and the environment. (UW2-33)

NRC Response: The NRC agrees, in part, with the comment. The United States experiences emergencies on some level on a regular basis, and a lack of preparedness can have serious consequences. However, the NRC is not required to assume that an offsite radiological release will happen but also does not assume that the probability of an offsite release is zero. EP is risk informed rather than risk based. Therefore, emergency planning is independent of accident probability. The risk-informed and consequence-oriented framework of 10 CFR 50.160 considers the potential consequences from a spectrum of accidents, including those that could result in an offsite radiological release and those that could not. The outcome is a graded approach to EP based on site-specific analyses.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment N-14: One commenter stated that investing all resources in renewable technologies, as some critics of nuclear energy have suggested, puts too much faith in technologies that have known drawbacks and no guaranteed path forward. The commenter asserts that nuclear energy is not without its own challenges, but it has the potential to be one of the cleanest energy sources out of the currently available technologies. The commenter stated that creating performance-based regulations, if done properly, will maintain the safety margins of nuclear power and supply an abundant amount of clean energy to the country. The commenter further wrote that the cleanest form of energy production (nuclear, wind, solar, or battery) will ultimately prevail. (RB-5)

NRC Response: The NRC agrees, in part, with these comments. The NRC agrees that a performance-based framework can maintain safety margins (i.e., provide reasonable assurance 121

of adequate protection of the public health and safety). However, the promotion of nuclear power, for any reason, is not one of the purposes of this rulemaking nor is it permissible under the NRCs statutory authority.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment N-15: A form letter campaign expressed concern that, by easing the regulatory burden and streamlining licensing procedures, the NRC is relinquishing its responsibility to protect the public under the AEA to industry financial interests. The commenter asserted that the public can have no confidence in the proposed rule and it should be rejected. (FL1-10)

NRC Response: The NRC disagrees with the comment. The use and regulation of small reactors and other advanced reactor designs and technology have been active topics of discussion between the NRC and a variety of stakeholders for more than 30 years. The NRC worked with stakeholders to develop the framework for the implementation of performance-based EP regulations and is not prioritizing the financial interests of the nuclear industry. Additionally, in January 2019, the President signed NEIMA into law, which requires that the NRC establish a risk-informed, technology-inclusive regulatory framework to license and oversee advanced nuclear technologies. EP requirements are a part of this framework.

Furthermore, as described in the NRC Response to Comment A-2.3, the level of EP will be the same under the final rule as it is under the current framework in 10 CFR 50.47(b) and Appendix E to 10 CFR Part 50, thereby affording the same level of protection of the public health and safety as the current regulatory framework.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment N-16: One commenter asserted that reducing or eliminating offsite plume exposure pathway EPZs for SMRs and other nuclear technologies is contradicted by retaining Price-Anderson Act (PAA) liability protection for SMR facilities. The commenter stated that this constitutes an admission that the offsite risks from a nuclear accident still require liability protection for the nuclear industry. The commenter said that if the risk of a significant accident posed by SMRs is truly reduced, then they should not be protected by the liability shelter of the PAA. The commenter wrote that the continued need for PAA coverage of SMR facilities indicates the NRC should not go forward with the proposed rule. (BN-7)

NRC Response: Whether applicants and licensees that comply with this final rule will need the same offsite insurance protection as the currently operating nuclear power reactor licensees is beyond the scope of this rulemaking, which establishes an alternative EP framework for SMRs and ONTs. As the NRC staff explained in the enclosure, Non-Light Water Reactor Implementation Action Plan Progress Summary and Future Plans, to SECY-21-0010, Advanced Reactor Program Status, dated February 1, 2021 (ADAMS Accession No. ML20345A239 (package)), [C]hanges to guidance or through rulemaking may be needed to develop a financial protection framework for advanced reactors, including the licensing of multi-module or multi-unit designs and facilities.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment N-17: The commenter asked if new and existing reactors rated at less than or equal to 1,000 MW(e) would be able to obtain EP licensing or relicensing under the proposed rule.

(PBRP-2) 122

NRC Response: The final rule applies to existing and future SMR and ONT facilities. In the final rule, 10 CFR 50.2 defines an SMR as a power reactor, which may be of modular design as defined in 10 CFR 52.1, licensed under 10 CFR 50.21 or 10 CFR 50.22 to produce heat energy up to 1,000 MW(t) per module. Because 1,000 MW(t) is equivalent to 300 MW(e), whether a facility rated at less than or equal to 1,000 MW(e) could use the EP framework of the final rule would depend on whether the MW(e) rating of the facility is less than or equal to 300 MW(e) per module.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment N-18: The commenter recommended that the NRC revise or remove the following statement, Emergency preparedness is risk-informed rather than risk-based, and therefore emergency planning is independent of accident probability. The commenter said that risk-informed is not equivalent to independent of accident probability, as accident probability still comprises some basis in a risk-informed approach. (NSA-7)

NRC Response: The NRC disagrees with the comment. The context of the statement, Emergency preparedness is risk-informed rather than risk-based, and therefore emergency planning is independent of accident probability, in the FRN is in reference to the EP planning basis and not to the spectrum of accidents that would be, tempered by accident probability, used as an input to the plume exposure pathway EPZ size determination.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment N-19: One commenter suggested that the proposed rulemaking should add a definition for the term power reactor. The commenter said that the rulemaking uses the term on multiple instances and that providing a definition would promote clarity. (NSA-26)

NRC Response: The NRC disagrees with the comment. This rulemaking establishes an alternative EP framework for SMRs and ONTs such as non-LWRs and certain NPUFs. The final rule establishes definitions in 10 CFR 50.2 for each type of affected facility under the rulemaking. Therefore, establishing a definition of power reactor is beyond the scope of the rulemaking.

In addition, the term power reactor is defined in 10 CFR 171.5 as a nuclear reactor designed to produce electrical or heat energy and licensed by the Commission under the authority of Section 103 or Subsection 104b of the AEA and pursuant to the provisions of 10 CFR 50.21(b) or 10 CFR 50.22. The term power reactor also is defined in 10 CFR 100.3 as a nuclear reactor of a type described in 10 CFR 50.21(b) or 10 CFR 50.22 designed to produce electrical or heat energy.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment N-20: One commenter asserted that there are gaps that need to be addressed in the proposed rule, specifically final design information, source term information, operational plans for fuel cycles, collocation considerations and guidance, and a spectrum of design accidents.

The commenter wrote that these gaps will need to be addressed during a licensing review but should not impact the development of the rule. (CLA-13)

NRC Response: The NRC agrees, in part, with the comment. The NRC disagrees that the rule has gaps that need to be addressed. Design-specific information that the commenter identifies 123

would be addressed and evaluated through the application and licensing process. The NRC agrees there is no impact on the rule itself.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment N-21: In response to comments arguing that SMRs and ONTs lack operational history, one commenter stated that it is within the NRCs mandate and character to assess the potential source term, potential accident scenarios, and ultimate safety of any new nuclear technologies. The commenter suggested that the NRC has the capability and responsibility to do this for existing technologies and those with little or no operational history. The commenter noted that source terms for SMRs are determined analytically and conservatively based on the characteristics of the technology. The commenter said that the NRCs exercise of this responsibility will protect the public and ensure the safety of nuclear facilities. (NNSA2-5)

NRC Response: The NRC agrees with the comment. As explained in the NRC Response to Comment D-1.15, this rulemaking is within the scope of the NRCs authority and, as described in the NRC Response to Comment D-3.11, capabilities.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment N-22: One commenter stated that any decisions regarding exemptions to current EP rules should be a part of an applicants COL or construction permit application and review process, and not evaluated with a predetermined set of exemptions. (UW2-37)

NRC Response: The NRC agrees, in part, with the comment. Licensing SMRs and ONTs within the current regulations, developed for LLWRs, would require approval of exemption requests. These would be part of an applicants COL or OL application if the applicant selected the EP requirements in 10 CFR 50.47(b) and Appendix E to 10 CFR Part 50. However, this approach could lead to inconsistencies and undue burden for applicants, licensees, and the NRC. Instead, this final rule provides an alternative EP frameworknot a predetermined set of exemptions from the current regulationsthat will eliminate the need for requests for exemptions.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment N-23: One commenter said that the NRC has not developed a specific regulatory framework for SMRs and ONTs. The commenter referred to the Oklo application and DG-1353 as examples of not having a firm regulatory framework for these types of facilities. (UW2-41)

NRC Response: The NRC disagrees with the comment. The NRC has a regulatory framework for licensing all reactor types, including SMRs and ONTs, and exemptions can be sought from this licensing framework. This final rule establishes an alternative EP framework for SMRs and ONTs. As a result, the rule would promote regulatory stability, predictability, and clarity, and reduce requests for exemptions from EP requirements. As required by NEIMA, the NRC is developing other regulations to provide a licensing framework for SMRs and ONTs.

Accordingly, the NRC did not change the rule language in response to this comment.

O. Outside the Scope of the Rulemaking 124

Comment O-1: Commenters requested changes to the NRCs requirements, guidance, and supporting analysis so protective actions have a net positive impact or do more good than harm. One commenter said that protective actions for the public in the event of an emergency could result in far more deaths than would have occurred due to radiation exposure with no protective actions taken. The commenter wrote that a fundamental consideration of radiation protection according to the National Council on Radiation Protection and Measurements and International Commission on Radiological Protection is justification, which is defined as Any decision that alters the radiation exposure situation should do more good than harm. Similarly, another commenter wrote that excessive emergency responses can have a greater risk than the initial accident, arguing that transportation during an evacuation or evacuating an oversized plume exposure pathway EPZ carries risk. One commenter cited the example of the Shoreham Nuclear Power Plant, arguing that regulations required excessive planning for evacuations that prevented it from opening, even though the chances of an incident were small. One commenter provided an extensive critique of the NRCs use of PAGs and other EP guidelines, such as the keyhole design of current LWR plume exposure pathway EPZ requirements. (TMY-1, TMY-2, MU-2, MU-5, MU-6, MU-8, MU-9, MU-11, MU-12, MU-14, AS-2)

NRC Response: These comments and proposed changes concern not only SMRs and ONTs but also the currently operating power reactors. For this reason, these comments are outside the scope of this rulemaking. However, the NRC received a petition for rulemaking seeking a change to the NRCs EP regulations and guidance to ensure that protective actions do more good than harm (ADAMS Accession No. ML20176A313). The NRC docketed that petition and assigned it Docket Number PRM-50-123 (Docket ID NRC-2020-0155). The NRC will address these comments in the PRM-50-123 proceeding.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment O-2: One commenter asserted that they are a targeted entity and listed several Department of Defense commands that have been executed. The commenter requested that their children be returned and given safe haven and travel. (CPX-1)

NRC Response: The comment is outside of the scope of this rulemaking.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment O-3: One commenter stated that Federal agencies have not responded to concerns about EP and its connection to nuclear facilities and materials. The commenter also questioned why the DOE has been allowed to promulgate what the commenter characterized as unsound and unsustainable policies. The commenter said they have an audit from 1981 that has not been addressed by the agency. The commenter also wrote that they have not heard back from the NRC about abuse of derivative scenarios in attempting to financialize policy issues.

Finally, the commenter said that the policy of sabotaging facilities and entities that require high-level oversight is completely unacceptable. (CCR-1)

NRC Response: The NRC urges the commenter to report radiological safety concerns using the Report a Safety or Security Concern link at the top of the NRCs home page (www.nrc.gov). The comment is outside of the scope of this rulemaking.

Accordingly, the NRC did not change the rule language in response to this comment.

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Comment O-4: One commenter provided a quote by President Trump, saying the President resembled a TV show from the 1950s. (AN3-1)

NRC Response: This comment is outside the scope of this rulemaking.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment O-5: One commenter wrote that the proposed offsite planning requirements are based on a voluntary proposal developed by a joint NRC-EPA Task Force issued December 1978, and following the Three Mile Island incident, FEMA assumed responsibility for all offsite nuclear emergency planning and response. The commenter added that during the 2012 Prairie Island Radiological EP exercise, FEMA evaluators were pressured to downgrade or dismiss compliance issues and Since then, the FEMA REP [radiological emergency preparedness] program has progressively declined. (KR-1, KR-2)

NRC Response: These comments either suggest no changes to the proposed rule or are outside of the scope of this rulemaking.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment O-6: Two commenters wrote that only after consultation and agreement from State and local authorities should changes to emergency plans for existing licensees be considered.

(IDPH-6, CRCPD-12)

NRC Response: This rulemaking did not contemplate changes to emergency plans for existing licensees. Therefore, this comment is outside of the scope of this rulemaking. Furthermore, if the NRC were to provide a performance-based, consequence-oriented approach to EP for these licensees, then the NRC would conduct rulemaking, as suggested in the proposed rule FRN.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment O-7: One commenter noted that radiological EP exercises were postponed in response to the COVID-19 pandemic. The commenter concluded that the FEMA REP program is not regarded as essential, but it should be. (KR-3)

NRC Response: The status of the FEMA REP Program is outside the scope of this rulemaking.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment O-8: One commenter recommended that the NRC let an applicant build a facility 1 mile from populations and test the proposed recommendations, and then solidify a new regulatory framework based on KwH [kilowatt hours] of generation. (DJ-2)

NRC Response: Where an applicant proposes to build a facility is outside the scope of this rulemaking. Also, as explained in the NRC Response to Comment A-2.2, the NRC has regulatory requirements to build and test new reactor facilities. The NRC provided information on this subject in Appendix A, Process for Determining Testing Needs, to A Regulatory Review Roadmap for Non-Light Water Reactors, issued December 2017 (ADAMS Accession No. ML17312B567). The NRC is considering additional guidance for applicants planning to submit applications to license advanced reactors closer to population centers. The NRC staff provided the Commission with such a proposal in SECY-20-0045, Population-Related Siting 126

Considerations for Advanced Reactors, dated May 8, 2020 (ADAMS Accession No. ML19262H055 (package)).

Accordingly, the NRC did not change the rule language in response to this comment.

Comment O-9: One commenter wrote that excessive evacuation rules forced the Shoreham Nuclear Power Plant to close, even though the chance of an accident was extremely small.

(TQ-2)

NRC Response: The use of evacuations as a protective measure is outside the scope of this rulemaking. See the NRC Response to Comment O-1 for more information on this topic.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment O-10: One commenter wrote that SMRs present new risks with regard to security and would generate more waste without a long-term solution for storage. (DGY-2, DGY-3)

NRC Response: Security and disposal of nuclear waste are outside the scope of this rulemaking.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment O-11: One commenter wrote that the proposed rule should include an analysis of the risks of a potential incident compared to the impact SMRs would have on climate change.

(TW-1)

NRC Response: Risks associated with accidents and benefits of SMRs to climate change are outside the scope of this rulemaking. These issues are licensing related, not EP related.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment O-12: One commenter requested that the NRC develop evidence-based regulations that best inform decisionmaking and do not overstate radiological risk. The commenter explained that exaggerated risk of radiation exposure does not protect the public and can encourage decisions that are harmful to both people and the environment. (HF-8)

NRC Response: Perceived radiological threats are outside the scope of the rulemaking. See the NRC Response to Comment O-1 for more information on this topic.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment O-13: One commenter requested that the NRC add language to the final rule that requires applicants and licensees to evaluate the offsite releases associated with adversary destruction of target sets and determine the most severe and/or bounding offsite release scenario for adversary actions. The commenter explained that this addition would ensure that the entire operation of an advanced nuclear reactor is taken into consideration in a performance-based model. Also, the commenter stated that this addition would provide a performance-based feedback into the Sites protective strategy, and match criteria included in the proposed rulemaking for Alternative Physical Security Requirement for Advanced Reactors published in April 2020, which would provide flexibility in reducing physical security requirements. Finally, the commenter said that this additional language would close the circle 127

for the purposes of forming the protective strategy, because the safety analysis forms the bases for target sets to prevent the releases hypothesized to inform the plume exposure pathway EPZ. (CC-2, CC-3, CC-4, CC-5, CC-6)

NRC Response: The NRC disagrees with the comments. Performance-based feedback related to target sets informing the plume exposure pathway EPZ and offsite release scenario from adversary actions related to the sites security protective strategy is outside the scope of this rule.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment O-14: One commenter expressed concern over the safety of sodium-cooled fast reactors (SFRs). The commenter said that sodium is an inferior coolant relative to molten salts and that it is chemically dangerous. The commenter wrote that when hydrogen is generated by a sodium reaction with liquid water or steam, the hydrogen may accumulate and can detonate under certain conditions. The commenter stated that in a hydrogen explosive accident that breaches reactor containment, radioactive coolant can be released into the environment. The commenter further said that the safety of SFR reactors such as the Integral Fast Reactor, Terrapower Traveling Wave Reactor, the Russian BN-800, and the GE S-Prism is not evidence enough that SFRs are a viable option. The commenter asserted that the general history of SFRs shows that their lifespans have been cut short by accidents. The commenter further wrote that it is difficult to evaluate the safety of SFRs as evaluators must scale figures from the French Superphenix to other designs. (RT-1, RT-2, RT-3)

NRC Response: The comments suggest no changes to the proposed rule. This rulemaking establishes an alternative, technology-inclusive EP framework for the regulation of SMRs and ONTs. Individual reactor technologies or designs are outside the scope of this rulemaking.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment O-15: One commenter and a form letter campaign expressed concern over nuclear licensee liability in the event of an accident. One commenter noted that under PAA, nuclear industry liability is limited to $13 billion and that victims are left to seek damages from the government, meaning taxpayers are footing the bill for industry failings. The commenter said that licensees must create and maintain emergency plans that enable citizens to quickly evacuate when safety measures fail and probability estimates prove incorrect. Another commenter wrote that as the PAA is set to expire in 2025, the NRC should add a provision that includes an insurance requirement for offsite liability to mirror the PAA if the PAA is not renewed or extended. The commenter said that adding an offsite liability provision would redirect the burden of an accident from communities to the nuclear industry. (SBT-5, FL1-6)

NRC Response: The NRC disagrees with the comments. Requiring additional offsite insurance protection is beyond the scope of this rulemaking, which establishes an alternative EP framework for SMRs and ONTs. The NRCs regulations related to financial protection requirements and indemnity agreements are located in 10 CFR Part 140. Additionally, while the PAA currently limits liability coverage to approximately $13 billion, Congress has explicitly committed to take necessary action to protect the public from the consequences of a disaster that would exceed coverage limits.

Accordingly, the NRC did not change the rule language in response to these comments.

128

Comment O-16: One commenter and a form letter campaign wrote that advanced reactors with a fast spectrum are effective at producing clean electricity and reducing radioactive waste.

The commenters further stated that these reactors are essential to closing the fuel cycle and converting spent fuel into more energy. (NR-5, FL2-4)

NRC Response: The comments suggest no changes to the proposed rule. This rulemaking establishes an alternative, technology-inclusive EP framework for the regulation of SMRs and ONTs. Individual reactor technologies or designs are outside the scope of this rulemaking.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment O-17: One commenter provided an overview of the benefits of small reactors. For example, the commenter stated that the benefits include job creation, more affordable energy, reliable power as a backup to solar and wind energy, and production of desalinated water, among others. (AD-1)

NRC Response: This comment suggests no changes to the proposed rule. This rulemaking establishes an alternative, technology-inclusive EP framework for the regulation of SMRs and ONTs. Individual reactor technologies or designs are outside the scope of this rulemaking.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment O-18: One commenter expressed concern over NRC assumptions regarding SMR nuclear waste. The commenter said that the NRCs assumptions regarding SMR waste streams are hypothetical and unsupported. The commenter stressed that the NRC should not reduce EP requirements based on these speculative assertions. The commenter cited research suggesting that the proposed NuScale reactor design would result in a 60-percent increase in spent fuel generated, and the volume of long-lived low- and intermediate-level nuclear waste generated is significantly larger than each unit of electricity relative to a standard LLWR. The commenter suggested that the NRC should evaluate SMR waste streams before they are licensed by the proposed rule. (SRA-10, SRA-11)

NRC Response: This rulemaking establishes an alternative EP framework for SMRs and ONTs. Nuclear waste and spent fuel storage are outside the scope of this rulemaking.

Accordingly, the NRC did not change the rule language in response to these comments.

Comment O-19: One commenter provided links to cooling systems and gravity distillation dehumidification systems. (EC-1)

NRC Response: The comment suggests no changes to the proposed rule. The designs provided by the commenter are not within the scope of this rulemaking. Further, the NRCs alternative EP framework does not encompass design characteristics of nuclear power plants.

Because this rulemaking would establish a technology-inclusive EP framework, individual reactor technologies or designs are outside the scope of this rulemaking.

Accordingly, the NRC did not change the rule language in response to this comment.

Comment O-20: One commenter stated that the linear no-threshold (LNT) argument used by critics of nuclear energy is unsubstantiated and is being disproved by modern research. The 129

commenter further wrote that to base any protective rule on LNT is wrong and that the method cannot be used to estimate the biological effects of ionizing radiation. (GHX-4)

NRC Response: The comment suggests no changes to the proposed rule. The use of LNT information is outside the scope of this rule.

Accordingly, the NRC did not change the rule language in response to this comment.

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Appendix A: Form Letter Submissions The U.S. Nuclear Regulatory Commission (NRC) received two sets of form letters on the proposed rule for emergency preparedness for small modular reactors and other new technology. Overall, there were 1,999 individual form letter submissions. Form Letter 1, which opposed the proposed rule, contained 1,976 submissions, and Form Letter 2, which supported the proposed rule, contained 23 submissions. For each set of form letter submissions, the NRC selected a master copy to bracket into individual comment excerpts, and then binned the excerpts to one of the 17 comment categories. The NRCs response to each form letter comment excerpt can be found by identifying the annotated submission abbreviation in the parenthetical list at the end of each comment summary. The table below contains the submission name of each form letter received, as well as the Agencywide Documents Access and Management System (ADAMS) accession number and the form letter submission abbreviation. In cases where the NRC received multiple submissions from the same name, the NRC added a number in parentheses next to the name in the table below. In some cases, the NRC received up to four (4) submissions from the same name.

ADAMS Submission Submission Name Accession No. Abbreviation Stephen Gliva ML20192A067 FL1 Alexander Whittle ML20192A067 FL1 Kevin Vaught ML20192A067 FL1 Tom Earnist ML20192A067 FL1 Randall Esperas ML20192A067 FL1 Joan Budd ML20192A067 FL1 William Edelman ML20192A067 FL1 Russell Ziegler ML20192A067 FL1 Valerie Guinan ML20192A067 FL1 I. Engle ML20192A067 FL1 Michael Lombardi ML20192A067 FL1 William DuSold ML20192A067 FL1 Kathryn Christian ML20192A067 FL1 Gary Gall ML20192A067 FL1 Ellen Halbert ML20192A067 FL1 Marya Zanders ML20192A067 FL1 Sam Sheldon ML20192A067 FL1 Joan Smith ML20192A067 FL1 Donna Blue ML20192A067 FL1 Lisa Mell ML20192A067 FL1 Dawn Albanese ML20192A067 FL1 Patrick Maloney ML20192A067 FL1 Virginia Davis ML20192A067 FL1 Rich Siegel ML20192A067 FL1 Mina Connor ML20192A067 FL1 Chris Beal ML20192A067 FL1 Bryan Bennett ML20192A067 FL1 Cynthia McNamara ML20192A067 FL1 Bryna Pizzo ML20192A067 FL1 Charles Davis ML20192A067 FL1 A-1

ADAMS Submission Submission Name Accession No. Abbreviation Don Hawkins ML20192A067 FL1 lj Okadlek ML20192A067 FL1 Lynne Teplin ML20192A067 FL1 Carolyn Pettis ML20192A067 FL1 Ann Coffey ML20192A067 FL1 Esther Boyd ML20192A067 FL1 Steven Miller ML20192A067 FL1 Frances Larson ML20192A067 FL1 Kenneth Ruby ML20192A067 FL1 Ronnie Perry ML20192A067 FL1 Kat Stephens ML20192A067 FL1 Mona Kandeler ML20192A067 FL1 Julie Skelton ML20192A067 FL1 Bonnie Murphy ML20192A067 FL1 Dr. Virginia Jones ML20192A067 FL1 Erin Garcia ML20192A067 FL1 Ken Loehlein ML20192A067 FL1 Paul Allard ML20192A067 FL1 Paige Harrison ML20192A067 FL1 George Stradtman ML20192A067 FL1 Ron Rattner ML20192A067 FL1 Timothy Schacht ML20192A067 FL1 Marta Schmidt ML20192A067 FL1 Dorothy Brooks ML20192A067 FL1 Paula Frighetti ML20192A067 FL1 Brenton Barnes ML20192A067 FL1 Sandra Cole ML20192A067 FL1 Nancy Morris ML20192A067 FL1 Don Thompson ML20192A067 FL1 David Hayes ML20192A067 FL1 Janice Foss ML20192A067 FL1 Norm Conrad ML20192A067 FL1 Tia Pearson ML20192A067 FL1 Arun Toke ML20192A067 FL1 Denise Giroux ML20192A067 FL1 Leslie Lomas (1) ML20192A067 FL1 Lisa Appleton ML20192A067 FL1 Leslie Lomas (2) ML20192A067 FL1 Nancy Moore ML20192A067 FL1 Leslie Lomas (3) ML20192A067 FL1 Harvey Fernbach MD MPH ML20192A067 FL1 Leslie Lomas (4) ML20192A067 FL1 Janice Niblack ML20192A067 FL1 Barbara Burnett ML20192A067 FL1 Laurette Culbert ML20192A067 FL1 Kelly Allison ML20192A067 FL1 Eric Lemberg ML20192A067 FL1 A-2

ADAMS Submission Submission Name Accession No. Abbreviation Carolyn Ludwig ML20192A067 FL1 Carol Taylor ML20192A067 FL1 Peter Kahigian ML20192A067 FL1 Carol Fletcher ML20192A067 FL1 Bruce Scharf ML20192A067 FL1 Roberta E. Newman ML20192A067 FL1 Jean Gore ML20192A067 FL1 Edward Norkus ML20192A067 FL1 Frances Goff ML20192A067 FL1 Julie Squire ML20192A067 FL1 Lee Hutchings ML20192A067 FL1 Cara Melbye ML20192A067 FL1 Monica M. Gallicho ML20192A067 FL1 Laura Silverman ML20192A067 FL1 Pamela Shaw ML20192A067 FL1 Daniel Kurz ML20192A067 FL1 Margery Winter ML20192A067 FL1 Steve Overton ML20192A067 FL1 Michael Sarabia ML20192A067 FL1 Lorraine D. Johnson ML20192A067 FL1 Nancy Ellingham ML20192A067 FL1 Maria Asteinza ML20192A067 FL1 Mary White ML20192A067 FL1 Diane Vandiver ML20192A067 FL1 Naomi Zuckerman ML20192A067 FL1 Brian Ainsley ML20192A067 FL1 Suzi Young ML20192A067 FL1 Matthew Franck ML20192A067 FL1 Jennifer Scott ML20192A067 FL1 Patricia Wynn ML20192A067 FL1 Maj(R) Douglas Gendron ML20192A067 FL1 Larry Morningstar ML20192A067 FL1 Lynne Harkins ML20192A067 FL1 Steve Rusk ML20192A067 FL1 Robert Edwards ML20192A067 FL1 John Petroni ML20192A067 FL1 Joy Baker ML20192A067 FL1 Karsten Mueller ML20192A067 FL1 Sandra Naidich ML20192A067 FL1 Masaaki Takeuchi ML20192A067 FL1 Susan Proietta ML20192A067 FL1 Jill Davine ML20192A067 FL1 Michael Daveiga (1) ML20192A067 FL1 Bill Ridgeway ML20192A067 FL1 Celeste Davis ML20192A067 FL1 Lillian Nordin ML20192A067 FL1 Bo Svensson ML20192A067 FL1 A-3

ADAMS Submission Submission Name Accession No. Abbreviation Beth Estelle ML20192A067 FL1 Doyle Rood ML20192A067 FL1 Georgii Billiris ML20192A067 FL1 David LaVerne ML20192A067 FL1 Joseph Shulman ML20192A067 FL1 Lynn C. Lang ML20192A067 FL1 Michael Daveiga (2) ML20192A067 FL1 Sandra Geist ML20192A067 FL1 Alex Fierro-Clarke ML20192A067 FL1 Lucie Mayer ML20192A067 FL1 Carol Sills ML20192A067 FL1 Robert Oberdorf ML20192A067 FL1 Stephen Schoo ML20192A067 FL1 Holly Kukkonen ML20192A067 FL1 LN ML20192A067 FL1 Rocio Lario ML20192A067 FL1 Doug Yamamoto ML20192A067 FL1 Charley Bowman ML20192A067 FL1 Gabrielle Swanberg ML20192A067 FL1 Andrew & Kathleen Wittenborn ML20192A067 FL1 Kathy Nickodemus ML20192A067 FL1 Eric Edwards ML20192A067 FL1 Peter Broderson ML20192A067 FL1 Loretta Kerns ML20192A067 FL1 Shelby L. Hood ML20192A067 FL1 Greg Espe ML20192A067 FL1 Nolan Turner ML20192A067 FL1 Karen Kravcov Malcolm ML20192A067 FL1 Anna Hennelly ML20192A067 FL1 John Paladin ML20192A067 FL1 Caren Thomas ML20192A067 FL1 Shari Hawk ML20192A067 FL1 Mari McShane ML20192A067 FL1 Nancy Boyce ML20192A067 FL1 Kathy Bradley ML20192A067 FL1 Randall Webb ML20192A067 FL1 Jan Hively ML20192A067 FL1 A. Todd ML20192A067 FL1 Julie Ford ML20192A067 FL1 Hal Anthony ML20192A067 FL1 Thomas Ferrito ML20192A067 FL1 Jeffery Garcia ML20192A067 FL1 Evan Sederquest ML20192A067 FL1 Matt Woolery ML20192A067 FL1 Kathleen Grossman ML20192A067 FL1 Carol Nugent ML20192A067 FL1 Jolynn Loftus ML20192A067 FL1 A-4

ADAMS Submission Submission Name Accession No. Abbreviation Robert Jehn ML20192A067 FL1 Cathy Barton ML20192A067 FL1 Vivian Dowell ML20192A067 FL1 Ellen Homsey ML20192A067 FL1 Kimberly Cresic ML20192A067 FL1 Ingrid Rochester ML20192A067 FL1 Kris Head ML20192A067 FL1 Brad Walker ML20192A067 FL1 Bernard Berauer ML20192A067 FL1 Gary Mazzotti ML20192A067 FL1 Abdullah Goldstein ML20192A067 FL1 Kym Waugh ML20192A067 FL1 Jenette DAlessandro ML20192A067 FL1 Marguerite Sgrillo ML20192A067 FL1 Elizabeth Schwartz ML20192A067 FL1 Michele Reed ML20192A067 FL1 Barbara Abolafia ML20192A067 FL1 Mollie Thomas ML20192A067 FL1 Sophie Diamond ML20192A067 FL1 Joan H. ML20192A067 FL1 Laura Leipzig (1) ML20192A067 FL1 Alena Jorgensen ML20192A067 FL1 Angie Johnson ML20192A067 FL1 Anguss Moss ML20192A067 FL1 Jane Butler ML20192A067 FL1 Richard Stevenson ML20192A067 FL1 Anne Harrison ML20192A067 FL1 Penny Heintz ML20192A067 FL1 Maggie Davidson ML20192A067 FL1 Margaret Dunn ML20192A067 FL1 Sandra M. Zwingelberg ML20192A067 FL1 Thomas Nieland (1) ML20192A067 FL1 Thomas Nieland (2) ML20192A067 FL1 Stephen Mudrick ML20192A067 FL1 Kurt Speidel ML20192A067 FL1 Melissa Thirloway ML20192A067 FL1 Rosemarie Pace ML20192A067 FL1 Steven Lowenthal ML20192A067 FL1 Sharon Colyar ML20192A067 FL1 John R. Thayer ML20192A067 FL1 Clarice Hearne ML20192A067 FL1 Jorge De Cecco ML20192A067 FL1 Cindy Borske ML20192A067 FL1 Joe Kaleel ML20192A067 FL1 Harriet McCleary ML20192A067 FL1 Marcel Liberge ML20192A067 FL1 Florence Kelly ML20192A067 FL1 A-5

ADAMS Submission Submission Name Accession No. Abbreviation Joanne Kundrat ML20192A067 FL1 George Lewis ML20192A067 FL1 Jean Stevens ML20192A067 FL1 Ramona Ponessa ML20192A067 FL1 Marilyn Rose ML20192A067 FL1 Ron Parsons ML20192A067 FL1 Sybil Kohl ML20192A067 FL1 Eva Curatolo ML20192A067 FL1 Charlene Woodcock ML20192A067 FL1 Lanie Cox ML20192A067 FL1 Lilinoe Smith ML20192A067 FL1 Carlton Russell ML20192A067 FL1 Bennie Woodard ML20192A067 FL1 A. Kasbarian ML20192A067 FL1 Peter Ayres ML20192A067 FL1 Stephen Boletchek ML20192A067 FL1 Tom Howell ML20192A067 FL1 Katherine OSullivan ML20192A067 FL1 Gerry Milliken ML20192A067 FL1 Lisa Stone ML20192A067 FL1 Marian Cruz ML20192A067 FL1 Joe Sain ML20192A067 FL1 Charles Byrne ML20192A067 FL1 Pamela Benton ML20192A067 FL1 Mary Loomba ML20192A067 FL1 Deborah Montero ML20192A067 FL1 Roel Cantú ML20192A067 FL1 Merja Harju ML20192A067 FL1 Judith Cohen ML20192A067 FL1 Mana Iluna ML20192A067 FL1 Darlene St. Martin ML20192A067 FL1 Susan Mirsky ML20192A067 FL1 Michael Parsons ML20192A067 FL1 Kate Skolnick ML20192A067 FL1 Ina Rogovin ML20192A067 FL1 Michael House ML20192A067 FL1 Molly Johnson ML20192A067 FL1 Dorotohy Werne ML20192A067 FL1 Jeff Komisarof ML20192A067 FL1 Randy Harrison ML20192A067 FL1 Linda Greene ML20192A067 FL1 Jean Kuntz ML20192A067 FL1 Stephan Hewitt ML20192A067 FL1 Michael F. Kolassa ML20192A067 FL1 Montie VanNostrand ML20192A067 FL1 Phyllis Chavez ML20192A067 FL1 Michael Earney ML20192A067 FL1 A-6

ADAMS Submission Submission Name Accession No. Abbreviation Laurel Davis-Delano ML20192A067 FL1 Arthur Kennedy ML20192A067 FL1 Calli Madrone ML20192A067 FL1 Dacia Murphy ML20192A067 FL1 Dana May ML20192A067 FL1 Ellen Murphy ML20192A067 FL1 K. Hafer ML20192A067 FL1 Anne Lakota ML20192A067 FL1 Benita J. Campbell ML20192A067 FL1 Madalyn Benoit ML20192A067 FL1 Keith DAlessandro ML20192A067 FL1 Susan Detato ML20192A067 FL1 Douglas Sedon ML20192A067 FL1 Chris Casper ML20192A067 FL1 Susan Hamilton ML20192A067 FL1 John Elder ML20192A067 FL1 Brenda J. Goode ML20192A067 FL1 Bart Ryan ML20192A067 FL1 Donald Taylor ML20192A067 FL1 Sarah Demb ML20192A067 FL1 Delores Stachura ML20192A067 FL1 Dorthee ML20192A067 FL1 Ken Lundgreen ML20192A067 FL1 James J. Fields ML20192A067 FL1 Edward Cutler ML20192A067 FL1 Darrel Follman ML20192A067 FL1 Carol Moss ML20192A067 FL1 Shelley Frazier ML20192A067 FL1 Hartson Doak ML20192A067 FL1 Donna Bonetti ML20192A067 FL1 Andra Heide ML20192A067 FL1 Sharon Lieberman ML20192A067 FL1 Stephen King ML20192A067 FL1 Glen Williams ML20192A067 FL1 Vicki Hughes ML20192A067 FL1 Marty Brown ML20192A067 FL1 Dudley and Candace Campbell ML20192A067 FL1 Johanna Cummings ML20192A067 FL1 Katherine Montague ML20192A067 FL1 Ed Ciaccio ML20192A067 FL1 Nancy Kosnar Hartman ML20192A067 FL1 Kristine Winnicki ML20192A067 FL1 Janet Saupp ML20192A067 FL1 Les Roberts ML20192A067 FL1 Joel Levine ML20192A067 FL1 Pat Blackwell-Marchant ML20192A067 FL1 Juanita Hull ML20192A067 FL1 A-7

ADAMS Submission Submission Name Accession No. Abbreviation Paul Palla ML20192A067 FL1 Huntley Hennessy ML20192A067 FL1 Peter Coleman ML20192A067 FL1 Jean-Francois Fauconnier ML20192A067 FL1 Paul Lennon ML20192A067 FL1 Matthew Reardon ML20192A067 FL1 Sandra Franz ML20192A067 FL1 Elizabeth Scherbak ML20192A067 FL1 Charles Clements ML20192A067 FL1 Marvin Rowe ML20192A067 FL1 Jason Hawkins ML20192A067 FL1 Arnold Gore ML20192A067 FL1 Richard Stern ML20192A067 FL1 Michael Zamm ML20192A067 FL1 Teresa Johnson ML20192A067 FL1 Kimberly Seger ML20192A067 FL1 Madeline Helbraun ML20192A067 FL1 Dominique Edmondson ML20192A067 FL1 Hal Forsen ML20192A067 FL1 Linda Murphy ML20192A067 FL1 T. F. ML20192A067 FL1 Connie Lippert ML20192A067 FL1 Tia Johnson ML20192A067 FL1 Deirdre Rose ML20192A067 FL1 Alvera Pritchard ML20192A067 FL1 Karen Stimson ML20192A067 FL1 Gregory Tabat ML20192A067 FL1 Gary Hull ML20192A067 FL1 Phil Klein ML20192A067 FL1 Karen Hadden ML20192A067 FL1 Ryk Diemert (1) ML20192A067 FL1 Yves Decargouet ML20192A067 FL1 Deborah L. Hall ML20192A067 FL1 Bill Holt ML20192A067 FL1 Doreen McElvany ML20192A067 FL1 Moe Kafka ML20192A067 FL1 Victoria Miller ML20192A067 FL1 John Webb (1) ML20192A067 FL1 Jane Reiter ML20192A067 FL1 Stephen Diamond ML20192A067 FL1 Lawrence McKinley ML20192A067 FL1 Anne Fishef ML20192A067 FL1 John Webb (2) ML20192A067 FL1 Julie Bush ML20192A067 FL1 Mike Kappus (1) ML20192A067 FL1 Michael Lahey ML20192A067 FL1 Chris King (1) ML20192A067 FL1 A-8

ADAMS Submission Submission Name Accession No. Abbreviation Chris King (2) ML20192A067 FL1 Karen Barton ML20192A067 FL1 Rebecca Tippens ML20192A067 FL1 Mike Kappus (2) ML20192A067 FL1 Cheryl Carnahan ML20192A067 FL1 Mary Froehlich ML20192A067 FL1 Merry Harsh ML20192A067 FL1 Tim Hayes ML20192A067 FL1 Kate Kenner ML20192A067 FL1 Thomas Warner ML20192A067 FL1 Michael Potter ML20192A067 FL1 Joshua Angelus ML20192A067 FL1 Stephen Brittle ML20192A067 FL1 Lisa Kellman ML20192A067 FL1 Michael Worsham ML20192A067 FL1 Shirley Ackerman ML20192A067 FL1 Timothy Mullen ML20192A067 FL1 Wendy Fast ML20192A067 FL1 Tom Tripp ML20192A067 FL1 Sharon Logan ML20192A067 FL1 David Butler (1) ML20192A067 FL1 Laurie Hope (1) ML20192A067 FL1 Kevin Rolfes ML20192A067 FL1 J. Pizzo ML20192A067 FL1 Jules Moritz ML20192A067 FL1 Coral Cadman ML20192A067 FL1 Nancee Noel ML20192A067 FL1 Susanne Hesse & Doug Dyer ML20192A067 FL1 Tim Fleischer ML20192A067 FL1 Donald Harland ML20192A067 FL1 John Conway ML20192A067 FL1 Kenneth Bowman ML20192A067 FL1 William Ryerson ML20192A067 FL1 Mary Boone ML20192A067 FL1 Rachael Pappano ML20192A067 FL1 Michael C. ML20192A067 FL1 Steven Daskal (1) ML20192A067 FL1 Laurel Facey ML20192A067 FL1 Amy Hutto ML20192A067 FL1 Mark Boone ML20192A067 FL1 Susan Saltzman ML20192A067 FL1 Kristin Huntoon ML20192A067 FL1 Mary True ML20192A067 FL1 Bridget Chapman ML20192A067 FL1 Steven Daskal (2) ML20192A067 FL1 Kathleen Ruiz ML20192A067 FL1 Alix Keast ML20192A067 FL1 A-9

ADAMS Submission Submission Name Accession No. Abbreviation Melvin Armolt ML20192A067 FL1 Jaszmene Smith ML20192A067 FL1 Lana Franchek ML20192A067 FL1 Jeffrey Dix ML20192A067 FL1 William Wurtz ML20192A067 FL1 Timothy Judson ML20192A067 FL1 Rochelle La Frinere ML20192A067 FL1 Michelle Kosinski ML20192A067 FL1 Janet Tauro ML20192A067 FL1 Nancy Wagner ML20192A067 FL1 Margaret C. McHugh ML20192A067 FL1 Kate Cloud ML20192A067 FL1 Jonathan Memmert ML20192A067 FL1 Brian Caldwell ML20192A067 FL1 Judy Knueven ML20192A067 FL1 Richard Han ML20192A067 FL1 Lyn Du Mont ML20192A067 FL1 John Guros ML20192A067 FL1 Zach Kadar ML20192A067 FL1 Peter Curia ML20192A067 FL1 Liz Dyer ML20192A067 FL1 Lisa Kagan ML20192A067 FL1 Jym Dyer ML20192A067 FL1 George Klipfel II ML20192A067 FL1 Elizabeth Dodd ML20192A067 FL1 Fran Post ML20192A067 FL1 Robert Lombardi ML20192A067 FL1 Roger Hughes ML20192A067 FL1 Theresa Moriarty McPhail ML20192A067 FL1 Anne Heaney ML20192A067 FL1 Kimberly Pettit ML20192A067 FL1 Tammy Fisher ML20192A067 FL1 Joel Masser ML20192A067 FL1 Rev. L. Cline ML20192A067 FL1 Joel Kay ML20192A067 FL1 Daniela Rossi ML20192A067 FL1 Rainbow Di Benedetto ML20192A067 FL1 Gary Rowland ML20192A067 FL1 William Gilbert ML20192A067 FL1 Meredith Needham ML20192A067 FL1 Sara Lang ML20192A067 FL1 Jacalyn Dinhofer ML20192A067 FL1 Yazmin Gonzalez ML20192A067 FL1 Marty Mason ML20192A067 FL1 PJ Mcdaniel ML20192A067 FL1 Dr. Lewis Cuthbert ML20192A067 FL1 Nicole Taylor ML20192A067 FL1 A-10

ADAMS Submission Submission Name Accession No. Abbreviation Robert Fischoff ML20192A067 FL1 Timothy Larkin ML20192A067 FL1 Tony Segura ML20192A067 FL1 Carol Ilic ML20192A067 FL1 Carol Collins ML20192A067 FL1 N. Refes ML20192A067 FL1 Darrel Easter ML20192A067 FL1 Patricia Loftman ML20192A067 FL1 Chris Jacobs ML20192A067 FL1 Samuel Durkin ML20192A067 FL1 Kevin Kamps ML20192A067 FL1 Gail Lack ML20192A067 FL1 Irene Saikevych ML20192A067 FL1 Bret Smith ML20192A067 FL1 Jana Perinchief ML20192A067 FL1 Carol Book ML20192A067 FL1 Janet Maker (1) ML20192A067 FL1 Robert McCombs ML20192A067 FL1 Stephen Sacks ML20192A067 FL1 Carol Anne Fusco ML20192A067 FL1 Gloria Picchetti ML20192A067 FL1 Elisabeth Price ML20192A067 FL1 Stephen Dickstein ML20192A067 FL1 Elaina Hatsis ML20192A067 FL1 P. Willa (1) ML20192A067 FL1 Peggy Gish ML20192A067 FL1 Pamela Gibberman ML20192A067 FL1 Sally Small ML20192A067 FL1 Steve Schueth ML20192A067 FL1 Margot Lenhart ML20192A067 FL1 António Eloy ML20192A067 FL1 Doris Applebaum ML20192A067 FL1 Shawn Alexander ML20192A067 FL1 Richard Tregidgo ML20192A067 FL1 Lynn Lavezzi ML20192A067 FL1 Josef Wyss-Lockner ML20192A067 FL1 Tim Duda ML20192A067 FL1 Ruth Koblenz ML20192A067 FL1 Chris Lindberg ML20192A067 FL1 Mr. & Mrs. Bruce Revesz ML20192A067 FL1 Bonnie German (1) ML20192A067 FL1 Bonnie German (2) ML20192A067 FL1 Barbara Brown ML20192A067 FL1 Grant Fujii ML20192A067 FL1 David Burns ML20192A067 FL1 Mark Soenksen ML20192A067 FL1 Donald Walsh ML20192A067 FL1 A-11

ADAMS Submission Submission Name Accession No. Abbreviation Patricia Levin ML20192A079 FL1 Nancy Lyles ML20192A079 FL1 Kirk Ramble ML20192A079 FL1 Hersha Evans ML20192A079 FL1 Brian Smith ML20192A079 FL1 Katie Scherfig ML20192A079 FL1 Tim Miller ML20192A079 FL1 Marnelle Curtis ML20192A079 FL1 ko ML20192A079 FL1 Gregory Duncan ML20192A079 FL1 Bernardo Alayza Mujica ML20192A079 FL1 A Rossner ML20192A079 FL1 Patty Bixler ML20192A079 FL1 Michael Crowden ML20192A079 FL1 Emily Rugel ML20192A079 FL1 Pat Hawthorn ML20192A079 FL1 Michael Odell ML20192A079 FL1 Dorri Raskin ML20192A079 FL1 Mark Hayduke Grenard ML20192A079 FL1 David Lax ML20192A079 FL1 Terry Crownover ML20192A079 FL1 Sabrina Eckles ML20192A079 FL1 Patricia Borchmann ML20192A079 FL1 Jerrold Allen ML20192A079 FL1 Linda McKillip ML20192A079 FL1 Dinah Starr ML20192A079 FL1 Martha E. Martin ML20192A079 FL1 Joseph Ponisciak ML20192A079 FL1 Adrian Bergeron ML20192A079 FL1 Rolf Friis ML20192A079 FL1 Shannon Healey ML20192A079 FL1 Molly Swabb ML20192A079 FL1 Ann Malyon (1) ML20192A079 FL1 Liz Erpelding-Garratt ML20192A079 FL1 Barbara Buck ML20192A079 FL1 Terrence Goebel ML20192A079 FL1 Sylvia Lambert ML20192A079 FL1 Susan Crowle ML20192A079 FL1 David Stanley ML20192A079 FL1 Will S ML20192A079 FL1 Stuart Francis ML20192A079 FL1 Henry Mobley ML20192A079 FL1 Doris (Jody) Wilson ML20192A079 FL1 Mark Blandford ML20192A079 FL1 Katherine Bryan ML20192A079 FL1 Ken Freedman ML20192A079 FL1 Carole Jones ML20192A079 FL1 A-12

ADAMS Submission Submission Name Accession No. Abbreviation Christy Giesick ML20192A079 FL1 Susan Warren ML20192A079 FL1 Devon Tipp ML20192A079 FL1 Tika Bordelon ML20192A079 FL1 Janet McCalister ML20192A079 FL1 Matthew Schaut ML20192A079 FL1 Lee Stanfield ML20192A079 FL1 David Bezansib ML20192A079 FL1 Sandra Lane ML20192A079 FL1 Sarah Bauman ML20192A079 FL1 Harold Watson ML20192A079 FL1 Kate Harder ML20192A079 FL1 John Doucette ML20192A079 FL1 Yen Vu ML20192A079 FL1 Rachel Lauze ML20192A079 FL1 Chris Nelson ML20192A079 FL1 Doug Mayor ML20192A079 FL1 Robert Cherwink ML20192A079 FL1 Kevin Schader ML20192A079 FL1 Mary Keithler ML20192A079 FL1 Lisa Gherardi ML20192A079 FL1 Amy Winter ML20192A079 FL1 William Schlesinger ML20192A079 FL1 L Nelson ML20192A079 FL1 Anita Brandariz ML20192A079 FL1 Jean Schwinberg ML20192A079 FL1 Maryellen Healy ML20192A079 FL1 Angela Fazzari ML20192A079 FL1 Lauren Murdock ML20192A079 FL1 Joan McGrath ML20192A079 FL1 Ruben Tamamian ML20192A079 FL1 Barbara Olson ML20192A079 FL1 Anthony Castillo ML20192A079 FL1 Richard Payne ML20192A079 FL1 Suzy Chaffee ML20192A079 FL1 Marie Curtis ML20192A079 FL1 Jon Singleton ML20192A079 FL1 Bruce von Alten ML20192A079 FL1 Kathie E Takush ML20192A079 FL1 Douglas Meyer ML20192A079 FL1 Daniel Schlagman ML20192A079 FL1 Jim and Barbara Dale ML20192A079 FL1 Carla Compton ML20192A079 FL1 Sandra Cais (1) ML20192A079 FL1 Liane Conn ML20192A079 FL1 Anne Huibregtse ML20192A079 FL1 Gary Thaler ML20192A079 FL1 A-13

ADAMS Submission Submission Name Accession No. Abbreviation Carol Wiley ML20192A079 FL1 Sandra Breakfield ML20192A079 FL1 Marion Jackson ML20192A079 FL1 Al Daniel ML20192A079 FL1 Joan Rosenbaum ML20192A079 FL1 Janet Handford ML20192A079 FL1 Sandra Cais (2) ML20192A079 FL1 Marian Volkman ML20192A079 FL1 Marilyn Field ML20192A079 FL1 Meryl Pinque ML20192A079 FL1 Ned Overton ML20192A079 FL1 Rik Masterson ML20192A079 FL1 Vivian S. Valtri Burgess ML20192A079 FL1 Stephanie C. Fox ML20192A079 FL1 Annette Pirrone ML20192A079 FL1 Michelle Trosper ML20192A079 FL1 Danielle Montague-Judd ML20192A079 FL1 Kristen Brooks ML20192A079 FL1 Nancy Iannuzzelli ML20192A079 FL1 Laura Horowitz ML20192A079 FL1 Nancy Almeida Crocker ML20192A079 FL1 Sandra Goettling ML20192A079 FL1 Susan Broadhead ML20192A079 FL1 Jenifer & John Massey ML20192A079 FL1 Gary Sibley ML20192A079 FL1 Gina Giaccardo ML20192A079 FL1 Corwin Khoe ML20192A079 FL1 Cheryl Carney (1) ML20192A079 FL1 Mike Duffy ML20192A079 FL1 Cheryl Carney (2) ML20192A079 FL1 Geoffrey Cook ML20192A079 FL1 ep ML20192A079 FL1 John Tovar ML20192A079 FL1 Charles Eiseman ML20192A079 FL1 Lacey Hicks ML20192A079 FL1 Alice McNally ML20192A079 FL1 Edie Pistolesi ML20192A079 FL1 Tom Cannon ML20192A079 FL1 Alan Lawrence ML20192A079 FL1 Jackie Tryggeseth ML20192A079 FL1 Faun Parliman ML20192A079 FL1 Annick Baaud ML20192A079 FL1 Dick Hogle ML20192A079 FL1 Penny Cragun ML20192A079 FL1 Barbara Poland ML20192A079 FL1 Jonathan Spencer ML20192A079 FL1 Frank Belcastro ML20192A079 FL1 A-14

ADAMS Submission Submission Name Accession No. Abbreviation Marta McCracken ML20192A079 FL1 Stephanie Low ML20192A079 FL1 Mary Yunker ML20192A079 FL1 Nancy Mead ML20192A079 FL1 Joanne Steele ML20192A079 FL1 Donna Smith ML20192A079 FL1 Shirley Jenkins ML20192A079 FL1 Peter Farris ML20192A079 FL1 Leslie Derbin ML20192A079 FL1 Rodney and Terri Jones ML20192A079 FL1 Steven & Susan Mayes ML20192A079 FL1 J Beverly ML20192A079 FL1 Anne Brennan ML20192A079 FL1 Charlotte Alexandre ML20192A079 FL1 Elliott Sernel ML20192A079 FL1 John Golding ML20192A079 FL1 Emily Rothman ML20192A079 FL1 Linda Ferland ML20192A079 FL1 Jeri Altman ML20192A079 FL1 Laura Lake ML20192A079 FL1 Anne Veraldi ML20192A079 FL1 Soretta Rodack ML20192A079 FL1 Craig Emerick ML20192A079 FL1 Eric Heystraeten ML20192A079 FL1 Paul Dolinko ML20192A079 FL1 Mike LaPorte ML20192A079 FL1 Patricia Heckart ML20192A079 FL1 Julie Takatsch ML20192A079 FL1 David Broadwater ML20192A079 FL1 Valerie Weiss ML20192A079 FL1 Timothy Shaw ML20192A079 FL1 Darcy Bergh ML20192A079 FL1 Rebecca McDonough ML20192A079 FL1 Joshua Seff ML20192A079 FL1 Danielle Hajdufi ML20192A079 FL1 Caroline Kipling ML20192A079 FL1 G Caviglia ML20192A079 FL1 Debbie Thomas ML20192A079 FL1 Steve Bear ML20192A079 FL1 Margaret Motley ML20192A079 FL1 William Christwitz ML20192A079 FL1 James Kleinert ML20192A079 FL1 David Monsees ML20192A079 FL1 Charleen Strelke ML20192A079 FL1 Sharon Bunch ML20192A079 FL1 Astrata Barber (1) ML20192A079 FL1 Carol Mock ML20192A079 FL1 A-15

ADAMS Submission Submission Name Accession No. Abbreviation Amaryntha Schalin (1) ML20192A079 FL1 Thomas Cox ML20192A079 FL1 Ed Oberweiser ML20192A079 FL1 Thomas Hernandez ML20192A079 FL1 David J Harris ML20192A079 FL1 Catherine Loudis ML20192A079 FL1 Mark Scibilia-Carver ML20192A079 FL1 Art Klein ML20192A079 FL1 Kathy Ruopp ML20192A079 FL1 Edna Mullen ML20192A079 FL1 Judith Beaver ML20192A079 FL1 Howard Hassman ML20192A079 FL1 Shearle Furnish ML20192A079 FL1 Lynette Strangstad ML20192A079 FL1 Kermit Cuff ML20192A079 FL1 Bettemae Johnson ML20192A079 FL1 Clifford Phillips ML20192A079 FL1 Alexander Honigsblum ML20192A079 FL1 Dana Bordegaray ML20192A079 FL1 Kay Reinfried ML20192A079 FL1 Margaret Cooney ML20192A079 FL1 Dylan Nguyen ML20192A079 FL1 Marie Alabiso ML20192A079 FL1 Carla Davis ML20192A079 FL1 Michael Salzmann ML20192A079 FL1 Nona Weiner ML20192A079 FL1 Claire Perricelli ML20192A079 FL1 Joe Connolly ML20192A079 FL1 Michel Dyer ML20192A079 FL1 Donald Johnson ML20192A079 FL1 Sarah Brownrigg ML20192A079 FL1 Sue Davies ML20192A079 FL1 Flora Martinez ML20192A079 FL1 Alice Bloch ML20192A079 FL1 Lynne Weiske ML20192A079 FL1 Max Wilder ML20192A079 FL1 Lucille Portner ML20192A079 FL1 Oleh Sydor (1) ML20192A079 FL1 Kareb Biesanz ML20192A079 FL1 Seth Snapp ML20192A079 FL1 Frank Gonzales Jr. ML20192A079 FL1 Susan Himes-Powers ML20192A079 FL1 Theodore Brazeau ML20192A079 FL1 June Cattell ML20192A079 FL1 Francine Ungaro ML20192A079 FL1 Brian Florian ML20192A079 FL1 Victor Paglia ML20192A079 FL1 A-16

ADAMS Submission Submission Name Accession No. Abbreviation Ann Mcentee ML20192A079 FL1 Annie Stevenson-King ML20192A079 FL1 Mark Hinds ML20192A079 FL1 James Mulder ML20192A079 FL1 Reed Fenton ML20192A079 FL1 Martha Atkinson ML20192A079 FL1 John Lindberg ML20192A079 FL1 Michele Barnard ML20192A079 FL1 Cheryl Kozanitas ML20192A079 FL1 Janet Bartos ML20192A079 FL1 Gerald Tichy ML20192A079 FL1 Carol A Newton ML20192A079 FL1 Steven Schafer ML20192A079 FL1 Jean Ross ML20192A079 FL1 Tami Palacky ML20192A079 FL1 R. Reyes ML20192A079 FL1 Ted Kozlowski ML20192A079 FL1 George E. Milkowski ML20192A079 FL1 Dan Schneider ML20192A079 FL1 Susan Kutz ML20192A079 FL1 Citizen Voter ML20192A079 FL1 Jan Barshiis ML20192A079 FL1 Twyla Meyer ML20192A079 FL1 Daphne Pleasonton ML20192A079 FL1 Richard Besco ML20192A079 FL1 Debb Atkinson ML20192A079 FL1 Diane Di Vittorio (1) ML20192A079 FL1 Diane Di Vittorio (2) ML20192A079 FL1 Joe Crymes ML20192A079 FL1 Kathy Yeomans ML20192A079 FL1 Ben Brooks ML20192A079 FL1 Norda Gromoll ML20192A079 FL1 Marsha Jarvis ML20192A079 FL1 James Corrigan ML20192A079 FL1 Mary McMahon ML20192A079 FL1 Danby Whitmore ML20192A079 FL1 Mark Rothstein (1) ML20192A079 FL1 Michael McMahan ML20192A079 FL1 Rama K Paruchuri ML20192A079 FL1 Brent Rocks ML20192A079 FL1 Jeffrey Cohen ML20192A079 FL1 Karl Koessel ML20192A079 FL1 Glenda Bissex ML20192A079 FL1 Pat Poggi ML20192A079 FL1 Herbert Lord ML20192A079 FL1 M Langelan ML20192A079 FL1 Carol Koehler ML20192A079 FL1 A-17

ADAMS Submission Submission Name Accession No. Abbreviation Susan Cox ML20192A079 FL1 Elyette Weinstein ML20192A079 FL1 Mark Koritz ML20192A079 FL1 Myrna Brittain ML20192A079 FL1 Robert Hasselbrink ML20192A079 FL1 Monte Hoskins ML20192A079 FL1 Holly Cohen ML20192A079 FL1 Freddie Williams ML20192A079 FL1 Lisa Witham ML20192A079 FL1 Sally Mavroides ML20192A079 FL1 Mark Hogarth ML20192A079 FL1 Jef Harvey ML20192A079 FL1 Rachel Wolf ML20192A079 FL1 Julia Cranmer ML20192A079 FL1 Andrew Lyall ML20192A079 FL1 Mary N. ML20192A079 FL1 Geraldine May ML20192A079 FL1 Elmo Dunn ML20192A079 FL1 Irene Gnemi ML20192A079 FL1 Tracy Foster ML20192A079 FL1 Mark Rothstein (2) ML20192A079 FL1 Tracy Feldman ML20192A079 FL1 Samuel Morningstar ML20192A079 FL1 Lawrence Cwik ML20192A079 FL1 Merilie Robertson ML20192A079 FL1 Marie Wakefield ML20192A079 FL1 Alan Stein ML20192A079 FL1 Barbara Langan ML20192A079 FL1 Martin Iseri ML20192A079 FL1 Stephen Appell ML20192A079 FL1 Ed Robertson ML20192A079 FL1 Jayson Luu ML20192A079 FL1 Jane Bunun ML20192A079 FL1 Joan Balfour ML20192A079 FL1 Leah Hallow ML20192A079 FL1 Greg Schwartz ML20192A079 FL1 Carol Joan Patterson ML20192A079 FL1 Valeri DeCastris ML20192A079 FL1 Diane DiFante ML20192A079 FL1 Nick Brannan ML20192A079 FL1 Lorraine Hartmann ML20192A079 FL1 Susan Walp ML20192A079 FL1 Donna Kittrell ML20192A079 FL1 Kathy Grieves ML20192A079 FL1 Mehdie Vakili ML20192A079 FL1 Ronald Drahos ML20192A079 FL1 Marc Alexander ML20192A079 FL1 A-18

ADAMS Submission Submission Name Accession No. Abbreviation Susan Lefler ML20192A079 FL1 Barbara MacAlpine ML20192A079 FL1 Jon Hager ML20192A079 FL1 Elizabeth Enright ML20192A079 FL1 Monika Jelonnek ML20192A079 FL1 Norman Illsley ML20192A079 FL1 Elizabeth Lynch ML20192A079 FL1 Joseph Corbett ML20192A079 FL1 Richard Peterson ML20192A079 FL1 Robert Shepherd ML20192A079 FL1 Sharon Sickles ML20192A079 FL1 Robbi Chisholm (1) ML20192A079 FL1 Deborah DeSimone ML20192A079 FL1 Aixa Fielder ML20192A079 FL1 Michael Hoover ML20192A079 FL1 Andreas Ohland ML20192A079 FL1 Tim Ryther ML20192A079 FL1 Michael Essex ML20192A079 FL1 Miriam Baum ML20192A079 FL1 Richard Crimbie ML20192A079 FL1 Elizabeth Ungar ML20192A079 FL1 Laura Prestridge ML20192A079 FL1 Alex Zukas ML20192A079 FL1 Gregory Rosasco ML20192A079 FL1 Stefanie Kaku ML20192A079 FL1 T. Mo ML20192A079 FL1 Jaib Hutzell ML20192A079 FL1 John Lopresti ML20192A079 FL1 Carole Henry ML20192A079 FL1 Jodi Daniels ML20192A079 FL1 Lasha Wells ML20192A079 FL1 Robbi Chisholm (2) ML20192A079 FL1 Hannah Walters ML20192A079 FL1 John Crombie ML20192A079 FL1 Hillary Wagner ML20192A079 FL1 George Bourlotos ML20192A079 FL1 Julie Ostoich ML20192A079 FL1 Anita Watkins ML20192A079 FL1 Marcy Gordon ML20192A079 FL1 LuMarion Conklin ML20192A079 FL1 Kurt Cruger ML20192A079 FL1 A vs ML20192A079 FL1 David Hand ML20192A079 FL1 Carol Grimm ML20192A079 FL1 Thomas Delegal ML20192A079 FL1 Steve Bloom ML20192A079 FL1 Elizabeth Watts ML20192A079 FL1 A-19

ADAMS Submission Submission Name Accession No. Abbreviation Patricia Nadreau ML20192A079 FL1 S. E. Williams ML20192A079 FL1 Lisa Patton ML20192A079 FL1 Marsha Schaub ML20192A079 FL1 Gilda Levinson ML20192A079 FL1 Gina Mori ML20192A079 FL1 Joel Trupin ML20192A079 FL1 Peter Gunther ML20192A079 FL1 Lynette Henderson ML20192A079 FL1 Donald Hunt ML20192A079 FL1 Phyllis Arist ML20192A079 FL1 Robert Brown ML20192A079 FL1 Jon Anderholm ML20192A079 FL1 Tammy King ML20192A079 FL1 Carol Held ML20192A079 FL1 Michele Chapman (1) ML20192A079 FL1 Laura Stewart ML20192A079 FL1 Jon Nadle ML20192A079 FL1 David Loy ML20192A079 FL1 Brandon Ballinger ML20192A079 FL1 Michele Chapman (2) ML20192A079 FL1 Raymond Nuesch ML20192A079 FL1 M.Sharon Gambocorto ML20192A079 FL1 Todd Somodevilla ML20192A079 FL1 Barbara Giorgio ML20192A079 FL1 Richard Sparkes ML20192A079 FL1 Lourdes Best ML20192A079 FL1 Barbara Jacobsen ML20192A079 FL1 Lois Lommel ML20192A079 FL1 Neely Lyles ML20192A079 FL1 Charles Comer ML20192A079 FL1 Dolores ODowd ML20192A079 FL1 Garry Star ML20192A079 FL1 Mike Lyons (1) ML20192A079 FL1 Michael Eichenholtz ML20192A079 FL1 Susan F Fleming ML20192A079 FL1 Mark Gotvald ML20192A079 FL1 Dennis Hoerner ML20192A079 FL1 Rilla Heslin (1) ML20192A079 FL1 Rilla Heslin (2) ML20192A079 FL1 John A Beavers ML20192A079 FL1 Robert Reed ML20192A079 FL1 Charlene Lauzon ML20192A079 FL1 T. Garmon (1) ML20192A079 FL1 Jason Steadmon ML20192A079 FL1 Mike Lyons (2) ML20192A079 FL1 Sue and John Morris ML20192A079 FL1 A-20

ADAMS Submission Submission Name Accession No. Abbreviation Pamylle Greinke ML20192A079 FL1 Joel Libman ML20192A079 FL1 Jack Roberts ML20192A079 FL1 Melissa Bauer ML20192A079 FL1 Freya Goldstein ML20192A079 FL1 Suzanne Kneeland ML20192A079 FL1 David Schachne ML20192A079 FL1 Nick Gaetano ML20192A079 FL1 Judi Poulson ML20192A079 FL1 Nick Bartol ML20192A079 FL1 Lynda Taylor ML20192A079 FL1 Susan Thompson ML20192A079 FL1 Christina Teunissen ML20192A079 FL1 Dee Spake ML20192A079 FL1 Hope Carr ML20192A079 FL1 Yvonne Martinez ML20192A079 FL1 Annabelle Herbert ML20192A079 FL1 T. LaRue ML20192A079 FL1 Mike Wheeler ML20192A079 FL1 Aron Shevis ML20192A079 FL1 Wayne Gibb ML20192A079 FL1 Jeffrey Bains ML20192A079 FL1 Steve Bush ML20192A079 FL1 William Claiborn ML20192A079 FL1 Harriet Chenkin ML20192A079 FL1 Paul Eisenberg ML20192A079 FL1 Jim Yarbrough ML20192A079 FL1 Sandra Couch ML20192A079 FL1 Celeste Howard ML20192A079 FL1 Patricia Borri ML20192A079 FL1 Clayton Cunha Filho ML20192A079 FL1 Eileen Howard ML20192A079 FL1 Bill Chockla ML20192A079 FL1 Michael Byrnes ML20192A079 FL1 Faith Weidner MD ML20192A079 FL1 Holger Mathews ML20192A079 FL1 Barbara Broz ML20192A079 FL1 David Stetler ML20192A079 FL1 Amy Henry ML20192A079 FL1 Urmila Padmanabhan ML20192A079 FL1 Michael Goebel ML20192A079 FL1 Jeremy Rossman ML20192A079 FL1 John Burke ML20192A079 FL1 Kyle Mayes ML20192A079 FL1 Pat Cavanaugh ML20192A079 FL1 Mary Rojeski ML20192A079 FL1 Marilyn Shepherd ML20192A079 FL1 A-21

ADAMS Submission Submission Name Accession No. Abbreviation Zola Packman ML20192A079 FL1 Meryl Rogers ML20192A079 FL1 Elizabeth Butler ML20192A079 FL1 Dana Bleckinger ML20192A079 FL1 Shawn Hall ML20192A079 FL1 AB ML20192A079 FL1 Roger Olsen ML20192A079 FL1 Roger Lippman (1) ML20192A079 FL1 Ana Chou ML20192A079 FL1 Charles Arnold ML20192A079 FL1 Felicia Bruce ML20192A079 FL1 Ronald Smith ML20192A079 FL1 Carol Devoss ML20192A079 FL1 Penny LaDeur ML20192A079 FL1 Nancy Brown (1) ML20192A079 FL1 Andrea Zajac ML20192A079 FL1 Niels Henrik Hooge ML20192A079 FL1 Robert McFarland ML20192A079 FL1 Marco Pardi ML20192A079 FL1 Louise Reardon ML20192A079 FL1 Peter Maly ML20192A079 FL1 F. Robert Wesley ML20192A079 FL1 Timothy Owen ML20192A079 FL1 Belle McMaster ML20192A079 FL1 Edward Butler ML20192A079 FL1 Don Thomsen ML20192A079 FL1 Elizabeth Kelly ML20192A079 FL1 Gerritt and Elizabeth Baker-Smith ML20192A079 FL1 James Mulcare ML20192A079 FL1 Luis Hestres ML20192A079 FL1 Tamadhur Al-Aqeel ML20205L565 FL1 Mary Landrum ML20205L565 FL1 Jeffrey Knopf ML20205L565 FL1 Gregory Freeman ML20205L565 FL1 Pat Pollard ML20205L565 FL1 Diana Heymann ML20205L565 FL1 Ann Malyon (2) ML20205L565 FL1 Jerry Wheeler ML20205L565 FL1 Julia Radwany ML20205L565 FL1 Francine Schwarzenberger ML20205L565 FL1 Gerald Stein ML20205L565 FL1 Peggy Stone ML20205L565 FL1 Colin Kay ML20205L565 FL1 Linda Wright ML20205L565 FL1 Vi Mooberry ML20205L565 FL1 David Damstrom ML20205L565 FL1 Suzanne Carlson ML20205L565 FL1 A-22

ADAMS Submission Submission Name Accession No. Abbreviation Sandra Sobek ML20205L565 FL1 Anne Rosati ML20205L565 FL1 Dev Klein ML20205L565 FL1 Elizabeth Hickman ML20205L565 FL1 Nicole Crane ML20205L565 FL1 Jean Hodgins ML20205L565 FL1 Ronald Partridge ML20205L565 FL1 Jonathan Evans ML20205L565 FL1 Kay Hawklee ML20205L565 FL1 Helen Johns ML20205L565 FL1 John Steponaitis ML20205L565 FL1 Donna Hreha ML20205L565 FL1 Daviann McClurg ML20205L565 FL1 Barbara Smith ML20205L565 FL1 June Adler ML20205L565 FL1 Alan Ticotsky ML20205L565 FL1 Melissa Elbrecht ML20205L565 FL1 Seth Mirsky ML20205L565 FL1 Mark Daniels ML20205L565 FL1 S. Peirce ML20205L565 FL1 Robert Reece ML20205L565 FL1 Robin Kory ML20205L565 FL1 Elizabeth Bryant ML20205L565 FL1 Len Clark ML20205L565 FL1 Howard Cohen ML20205L565 FL1 Victoria DeSarno ML20205L565 FL1 Jim Pounds ML20205L565 FL1 David Butler (2) ML20205L565 FL1 Nora Reid-leZotte ML20205L565 FL1 K. Krupinski ML20205L565 FL1 K. R. Garland PhD DD (1) ML20205L565 FL1 K. R. Garland PhD DD (2) ML20205L565 FL1 Joan Langue ML20205L565 FL1 Mark Wheeler ML20205L565 FL1 Marilyn Kaggen ML20205L565 FL1 Don Preister ML20205L565 FL1 Roger Lippman (2) ML20205L565 FL1 Patricia Kendall ML20205L565 FL1 Steve Shapiro ML20205L565 FL1 Shari Kelts ML20205L565 FL1 Nicholas Patton ML20205L565 FL1 Dorothy Sanchez ML20205L565 FL1 Doro Reeves ML20205L565 FL1 Lisa Schwartz ML20205L565 FL1 Dipl. Des. Kai Heinrich ML20205L565 FL1 Guy Zahller ML20205L565 FL1 Stephen Nickels ML20205L565 FL1 A-23

ADAMS Submission Submission Name Accession No. Abbreviation Diane Rencher ML20205L565 FL1 Dori Grasso ML20205L565 FL1 William Blair ML20205L565 FL1 Gloria Sennert ML20205L565 FL1 Rob Kulakofsky ML20205L565 FL1 Bonita Shea ML20205L565 FL1 Tracey Bonner ML20205L565 FL1 Erik Nielsen ML20205L565 FL1 Michael Mannion ML20205L565 FL1 Daniel Weiss ML20205L565 FL1 Kathleen Mireault ML20205L565 FL1 Jodi Rodar ML20205L565 FL1 Linda Lane ML20205L565 FL1 Doree Christensen ML20205L565 FL1 Kevin Bennett ML20205L565 FL1 Rebecca Rose ML20205L565 FL1 Linda Park ML20205L565 FL1 James Hartley ML20205L565 FL1 Sr. Sharon Zayac ML20205L565 FL1 Pamela Nordhof ML20205L565 FL1 Mari Mennel-Bell ML20205L565 FL1 Lorraine Moore ML20205L565 FL1 Myra Toth ML20205L565 FL1 Lori Jo Siegel ML20205L565 FL1 Alicia Salazar ML20205L565 FL1 James Monroe ML20205L565 FL1 Daniel L. Harris ML20205L565 FL1 G. John Balogh ML20205L565 FL1 Sarah Cooke ML20205L565 FL1 Lesley Pleasant ML20205L565 FL1 Paula Boardman ML20205L565 FL1 Loretta Larkin ML20205L565 FL1 Mary Peterson ML20205L565 FL1 Gloria Diggle ML20205L565 FL1 Jane Cates ML20205L565 FL1 Marjorie Clisson ML20205L565 FL1 Gerry Archibald ML20205L565 FL1 Susan Morris ML20205L565 FL1 Liz Baum ML20205L565 FL1 Lara Miletta ML20205L565 FL1 William Hassig ML20205L565 FL1 Cindy Beckkey ML20205L565 FL1 Michelle Carter ML20205L565 FL1 Stan Blecher ML20205L565 FL1 Patrick Donaldson ML20205L565 FL1 Ellen Rice ML20205L565 FL1 Allan Glick ML20205L565 FL1 A-24

ADAMS Submission Submission Name Accession No. Abbreviation Molly Brewer ML20205L565 FL1 John Six ML20205L565 FL1 John Liss ML20205L565 FL1 Michael Morgan ML20205L565 FL1 Leslie Gold ML20205L565 FL1 Sandy Sage ML20205L565 FL1 P. A. Paye ML20205L565 FL1 Allan Walters ML20205L565 FL1 Elinor Weiss ML20205L565 FL1 Marji Mendelsohn ML20205L565 FL1 Geraldine Aird ML20205L565 FL1 Jean Claude Louhisdon ML20205L565 FL1 Michael Abler ML20205L565 FL1 Ross Lockridge ML20205L565 FL1 Linda Rucci ML20205L565 FL1 Carolyn Riddle ML20205L565 FL1 Jennifer Kopczynski ML20205L565 FL1 Clark Crowe ML20205L565 FL1 Alice Vedova ML20205L565 FL1 Christina Babst ML20205L565 FL1 Margaret Wessels ML20205L565 FL1 Robin Dash ML20205L565 FL1 Regene Silver (1) ML20205L565 FL1 Regene Silver (2) ML20205L565 FL1 Lynda LaHue (1) ML20205L565 FL1 Lynda LaHue (2) ML20205L565 FL1 Kim Bigley ML20205L565 FL1 Lynda LaHue (3) ML20205L565 FL1 Marian Ronan ML20205L565 FL1 Helen Stuehler ML20205L565 FL1 Leona Klerer ML20205L565 FL1 Victoria Sepulveda ML20205L565 FL1 Ruth Lovinsohn (1) ML20205L565 FL1 Ruth Lovinsohn (2) ML20205L565 FL1 David Henning ML20205L565 FL1 Tara Mae ML20205L565 FL1 Dorothy Johnson ML20205L565 FL1 David Ellison ML20205L565 FL1 Carol Gay ML20205L565 FL1 Robert Kolkebeck ML20205L565 FL1 Joseph Quirk ML20205L565 FL1 Elena Rumiantseva ML20205L565 FL1 A. McGarry ML20205L565 FL1 K. Bensusen ML20205L565 FL1 Sharon Wilensky ML20205L565 FL1 Jerry Smith ML20205L565 FL1 Gayle Smith ML20205L565 FL1 A-25

ADAMS Submission Submission Name Accession No. Abbreviation Tracy Cole ML20205L565 FL1 David Rice ML20205L565 FL1 Bob Ramlow ML20205L565 FL1 Chris Ferrio ML20205L565 FL1 Arthur Hansen ML20205L565 FL1 Denise Lytle ML20205L565 FL1 Ed Fiedler ML20205L565 FL1 Jesse Hunter ML20205L565 FL1 Audrey Clement ML20205L565 FL1 Evelyn Verrill ML20205L565 FL1 Heather Davis ML20205L565 FL1 Nancy Caponi ML20205L565 FL1 Anne Tuddenham ML20205L565 FL1 Cynthia Molinero ML20205L565 FL1 Susan Kassouf ML20205L565 FL1 Karen Suyemoto ML20205L565 FL1 Duncan Brown ML20205L565 FL1 Amitav Dash ML20205L565 FL1 Beverly Harris ML20205L565 FL1 Larry Daniell ML20205L565 FL1 Anne Craig ML20205L565 FL1 Robin Kladke ML20205L565 FL1 Melissa Heller-Booth ML20205L565 FL1 Joan Breiding ML20205L565 FL1 Devon Hildreth ML20205L565 FL1 Laurie Hope (2) ML20205L565 FL1 Jeannie Park ML20205L565 FL1 Joel Porter ML20205L565 FL1 Marija Kljuce ML20205L565 FL1 Vladimir Levchenko ML20205L565 FL1 Theresa Owens ML20205L565 FL1 Sharon Frank ML20205L565 FL1 Jaymee Workman ML20205L565 FL1 Helen Syen ML20205L565 FL1 Christine Garofalo ML20205L565 FL1 Lyn Capurro ML20205L565 FL1 Heather Servais ML20205L565 FL1 Robin Perry ML20205L565 FL1 Cheryl Fergeson ML20205L565 FL1 Nick Berezansky ML20205L565 FL1 Arthur Bogie ML20205L565 FL1 John Velner ML20205L565 FL1 Dwight Hughes ML20205L565 FL1 John Moszyk ML20205L565 FL1 Carolyn Shafer ML20205L565 FL1 Linda Keir ML20205L565 FL1 Melba Dlugonski ML20205L565 FL1 A-26

ADAMS Submission Submission Name Accession No. Abbreviation John Zahos ML20205L565 FL1 Kimberly Wiley ML20205L565 FL1 Jocelyn DeCrescenzo ML20205L565 FL1 Neal Ferris ML20205L565 FL1 Susan Perez ML20205L565 FL1 Carl May ML20205L565 FL1 Satya Vayu ML20205L565 FL1 Fredric Hefter ML20205L565 FL1 Ken Bossong (1) ML20205L565 FL1 Marian Cooley ML20205L565 FL1 Virginia Bottorff ML20205L565 FL1 Scott Grinthal ML20205L565 FL1 Karen Peterson ML20205L565 FL1 Brian Habenicht ML20205L565 FL1 N. J. Bast ML20205L565 FL1 Anthony Szilagye ML20205L565 FL1 Dana Abbott ML20205L565 FL1 Clara Guerrero ML20205L565 FL1 Beth Goode ML20205L565 FL1 Orrin Merritt ML20205L565 FL1 Priscilla Newcomer ML20205L565 FL1 Tim Stein ML20205L565 FL1 Kellie F. ML20205L565 FL1 Katherine Tomasello ML20205L565 FL1 Sara Cox ML20205L565 FL1 Terumi Teraao ML20205L565 FL1 Thomas Talbot ML20205L565 FL1 Bonnie McGill ML20205L565 FL1 Micaela Pronio ML20205L565 FL1 Kathy Kosinski ML20205L565 FL1 Florence Harty ML20205L565 FL1 Christine Walturz ML20205L565 FL1 Karen Milstein ML20205L565 FL1 Amy Cusick ML20205L565 FL1 Carol Przybylak ML20205L565 FL1 MaryAnna Foskett ML20205L565 FL1 Robert L. Oman ML20205L565 FL1 Vincent Rubino ML20205L565 FL1 Andy Lupenko ML20205L565 FL1 Rick Geyer ML20205L565 FL1 Carolyn Wacaser ML20205L565 FL1 Marleny M. ML20205L565 FL1 Kathryn Lilley ML20205L565 FL1 Lee Dublin ML20205L565 FL1 Sandra Booth ML20205L565 FL1 Art Hanson ML20205L565 FL1 Debra Stoleroff (1) ML20205L565 FL1 A-27

ADAMS Submission Submission Name Accession No. Abbreviation Dita -kali ML20205L565 FL1 Robert Glover ML20205L565 FL1 Judy Foster ML20205L565 FL1 Peter Melka ML20205L565 FL1 Dorothy Kraemer ML20205L565 FL1 Bonnie Yohe ML20205L565 FL1 Lynne Draper ML20205L565 FL1 Maria Millar ML20205L565 FL1 Sammy Low ML20205L565 FL1 Jenni Kovich ML20205L565 FL1 Adina Parsley ML20205L565 FL1 Doug Fraanklin ML20205L565 FL1 Steve Hopkins ML20205L565 FL1 Bernadine Young ML20205L565 FL1 Sam Holden ML20205L565 FL1 Dorothy Dobbyn ML20205L565 FL1 Heath Post ML20205L565 FL1 Sandra Mardigian ML20205L565 FL1 Peter Meissner ML20205L565 FL1 David Trione ML20205L565 FL1 Carmela Sudano ML20205L565 FL1 Eric Parker ML20205L565 FL1 Kathleen Hannan (1) ML20205L565 FL1 Kathleen Hannan (2) ML20205L565 FL1 Diana Saxon ML20205L565 FL1 Deborah Cate ML20205L565 FL1 Nancy Enkiri ML20205L565 FL1 Linda Townley ML20205L565 FL1 Sue Colucci ML20205L565 FL1 Craig Cline ML20205L565 FL1 John Culloty ML20205L565 FL1 Rita Gugliotta ML20205L565 FL1 Judith Hazelton ML20205L565 FL1 Ran Zirasri ML20205L565 FL1 Leigh Steele ML20205L565 FL1 Mary Counihan ML20205L565 FL1 Glenn Brownton ML20205L565 FL1 Laura Hanks ML20205L565 FL1 Dave Parrish (1) ML20205L565 FL1 Erica Stanojevic ML20205L565 FL1 Carolyn Treadway ML20205L565 FL1 A. G. Sharpe-Torres ML20205L565 FL1 Cindy Meyers ML20205L565 FL1 Fred Lavy ML20205L565 FL1 Susannah Masarie ML20205L565 FL1 Marcia Halligan ML20205L565 FL1 Thomas De Pree ML20205L565 FL1 A-28

ADAMS Submission Submission Name Accession No. Abbreviation John Catherine ML20205L565 FL1 Jamie Guy Ostrowski ML20205L565 FL1 Joel Leitner ML20205L565 FL1 Joanne Hesselinmk ML20205L565 FL1 Tom Hougham ML20205L565 FL1 Kerry Mortensen ML20205L565 FL1 Judy Nakadegawa ML20205L565 FL1 Monica OBrien ML20205L565 FL1 Kirk Miller ML20205L565 FL1 Robert Lieber ML20205L565 FL1 Paul Lapidus ML20205L565 FL1 Barbara Brigham ML20205L565 FL1 Tim King ML20205L565 FL1 Jack Ray ML20205L565 FL1 Elizabeth ODear ML20205L565 FL1 Terrie Williams ML20205L565 FL1 Charles Pohlod ML20205L565 FL1 Paul Turner ML20205L565 FL1 Joan Yater ML20205L565 FL1 Jill B. ML20205L565 FL1 Janelle Murphy ML20205L565 FL1 Regina Logue ML20205L565 FL1 Holly Huntley ML20205L565 FL1 Dixie van der Kamp ML20205L565 FL1 Lisa Ehle ML20205L565 FL1 Susan Tucker ML20205L565 FL1 Ann Behrmann ML20205L565 FL1 Julienne DeMarsh ML20205L565 FL1 Nancy LaPlaca ML20205L565 FL1 Raymond & Christine Gicela ML20205L565 FL1 Ruth Panella ML20205L565 FL1 Mary S. Gregg ML20205L565 FL1 Julie Berberi (1) ML20205L565 FL1 Julie Berberi (2) ML20205L565 FL1 Vernon Batty ML20205L565 FL1 Lee Greenawalt (1) ML20205L565 FL1 Pam Speagle ML20205L565 FL1 Carl Pribanic ML20205L565 FL1 Dennis Nelson (1) ML20205L565 FL1 Merle Showers ML20205L565 FL1 Bernie Zelazny ML20205L565 FL1 Gordon Murphy ML20205L565 FL1 Bruce Cratty ML20205L565 FL1 Jack Bubenick ML20205L565 FL1 Carol Kussart ML20205L565 FL1 Kristi Collins ML20205L565 FL1 Charles Leiden ML20205L565 FL1 A-29

ADAMS Submission Submission Name Accession No. Abbreviation Richard Heinlein ML20205L565 FL1 Dmitry Landa ML20205L565 FL1 Dolores Parra ML20205L565 FL1 Peter Lee ML20205L565 FL1 Pat Magrath ML20205L565 FL1 Tracy Mcdonald ML20205L565 FL1 Axel Vogt ML20205L565 FL1 Joe Tricase ML20205L565 FL1 Albert Snow ML20205L565 FL1 Joseph Dadgari ML20205L565 FL1 Ellen Atkinson ML20205L565 FL1 Joan Lobell ML20205L565 FL1 Mary Sullivan ML20205L565 FL1 Nick Marling ML20205L565 FL1 Geri Collecchia ML20205L565 FL1 Mary Hahn ML20205L565 FL1 Michael Tomczyszyn ML20205L565 FL1 Donna Browne ML20205L565 FL1 Alice Anne Martineau ML20205L565 FL1 Megan Warren ML20205L565 FL1 qq ML20205L565 FL1 Carol Scher ML20205L565 FL1 Santiago Munoz Sebastián ML20205L565 FL1 Camille Gilbert ML20205L565 FL1 Ken Fogel ML20205L565 FL1 Sue Halligan ML20205L565 FL1 Kirk Bails ML20205L565 FL1 Kathryn Lambros ML20205L565 FL1 Randy Gerlach ML20205L565 FL1 Jane Yater ML20205L565 FL1 Christine Popowski ML20205L565 FL1 Dennis Hester ML20205L565 FL1 Dixie Belcher ML20205L565 FL1 Marianne Flanagan ML20205L565 FL1 Sandra Woodall ML20205L565 FL1 Laurie Alexander ML20205L565 FL1 Brett Tharp ML20205L565 FL1 Pat Dawson ML20205L565 FL1 Dr. William Skip Dykoski (1) ML20205L565 FL1 Dr. William Skip Dykoski (2) ML20205L565 FL1 Tania Malven ML20205L565 FL1 John Dunn ML20205L565 FL1 Wendy Larson ML20205L565 FL1 Michael Kast ML20205L565 FL1 Gloria Krueger ML20205L565 FL1 Karen D. Felts ML20205L565 FL1 Croitiene ganMoryn ML20205L565 FL1 A-30

ADAMS Submission Submission Name Accession No. Abbreviation Jennifer Cunningham ML20205L565 FL1 Matt Cornell ML20205L565 FL1 Larry Lambeth ML20205L565 FL1 Bruce Rauscher ML20205L565 FL1 Michelle Pavcovich ML20205L565 FL1 Pat and Gary Gover ML20205L565 FL1 Chris Kermiet ML20205L565 FL1 Kate Goetz ML20205L565 FL1 Claudia Bosshammer-Bilimek ML20205L565 FL1 Jon Bazinet ML20205L565 FL1 William Justis ML20205L565 FL1 Esther Garvett ML20205L565 FL1 Tlaloc Tokuda ML20205L565 FL1 Martha Goldin ML20205L565 FL1 Nelson Stockdill ML20205L565 FL1 Carol Gordon ML20205L565 FL1 Lula Shoberg ML20205L565 FL1 Cynthia McCarthy ML20205L565 FL1 Margaret Phelps ML20205L565 FL1 D. Rincon ML20205L565 FL1 Roxann Carmean Floyd ML20205L565 FL1 Sheila Parks ML20205L565 FL1 Wolfgang Loera ML20205L565 FL1 Sam King ML20205L565 FL1 Jesse Calderon ML20205L565 FL1 Christopher Kustra ML20205L565 FL1 Donna Ksczanowicz ML20205L565 FL1 Hillary Ostrow ML20205L565 FL1 Nancy Brown (2) ML20205L565 FL1 Robert Handelsman ML20205L565 FL1 Tyra Pellerin ML20205L565 FL1 Carol Myers ML20205L565 FL1 S Nam ML20205L565 FL1 Natalie Houghton ML20205L565 FL1 Stewart Casey ML20205L565 FL1 Cynthia Morrell ML20205L565 FL1 Sue Malone ML20205L565 FL1 Ingeborg Glier ML20205L565 FL1 Eric Decker ML20205L565 FL1 Gabriel Varkonyi ML20205L565 FL1 Carolyn Massey (1) ML20205L565 FL1 Davin Peterson ML20205L565 FL1 B. Chan ML20205L565 FL1 Nathan Coles ML20205L565 FL1 Jennifer Smith ML20205L565 FL1 Timothy Lippert ML20205L565 FL1 Joshua Heffron ML20205L565 FL1 A-31

ADAMS Submission Submission Name Accession No. Abbreviation Melvin Zimmerman ML20205L565 FL1 Diane Hart ML20205L565 FL1 Kimberly Allen ML20205L565 FL1 Susan Porter ML20205L565 FL1 J. Allen Feryok ML20205L565 FL1 Charles Miller ML20205L565 FL1 Deborah Voves ML20205L565 FL1 Ronald Cook ML20205L565 FL1 Virginia Jastromb ML20205L565 FL1 Gaia Cooksey ML20205L565 FL1 Joseph Lipsey ML20205L565 FL1 Beth Huizenga ML20205L565 FL1 Janice Hoffman ML20205L565 FL1 Jenna Fallaw ML20205L565 FL1 Bob Fischella ML20205L565 FL1 F. Olson ML20205L565 FL1 Monique Edwards ML20205L565 FL1 Nancy Currah (1) ML20205L565 FL1 Joan Pratt ML20205L565 FL1 Sara Hayes ML20205L565 FL1 Richard Patenaude ML20205L565 FL1 Donna Knipp ML20205L565 FL1 Scott Chase ML20205L565 FL1 Richard Booth ML20205L565 FL1 Evan Hartman ML20205L565 FL1 Linda Prostko ML20205L565 FL1 Michael Wollman ML20205L565 FL1 Shanna Crockett ML20205L565 FL1 Thomas Holubeck ML20205L565 FL1 Karin Nelson-Rogers ML20205L565 FL1 Susan Space ML20205L565 FL1 Gilda Fusilier ML20205L565 FL1 Helene Rosen (1) ML20205L565 FL1 Helene Rosen (2) ML20205L565 FL1 Warren Green ML20205L565 FL1 Mitchell Maricque ML20205L565 FL1 Rosalind Bresnahan ML20205L565 FL1 Carol Weaver ML20205L565 FL1 Pamela VourosCallahan ML20205L565 FL1 F. Corr ML20205L565 FL1 Wes Weaver ML20205L565 FL1 Tom Csuhta ML20205L565 FL1 Emily Bryant ML20205L565 FL1 Chris Monti ML20205L565 FL1 Karen Berger ML20205L565 FL1 Roberta Stern ML20205L565 FL1 Gaynelle Predmore ML20205L565 FL1 A-32

ADAMS Submission Submission Name Accession No. Abbreviation Jumpei Kawakami ML20205L565 FL1 Dennis Ledden ML20205L565 FL1 Dennis Schaef ML20205L565 FL1 Kay Olan ML20205L565 FL1 P. Willa (2) ML20205L565 FL1 Aleks Kosowicz ML20205L565 FL1 Kathy Abby ML20205L565 FL1 Linda Fielder ML20205L565 FL1 Pati Tomsits (1) ML20205L565 FL1 Pati Tomsits (2) ML20205L565 FL1 Pati Tomsits (3) ML20205L565 FL1 Robert Koopmans ML20205L565 FL1 Susan Heath ML20205L565 FL1 Kay Brainerd (1) ML20211L855 FL1 Felicia Bander ML20211L855 FL1 Amy DeSantis ML20211L855 FL1 Andrew Sutphin ML20211L855 FL1 Dolores Pino ML20211L855 FL1 Pamela Osgood ML20211L855 FL1 Joseph & Sandra Windwalker ML20211L855 FL1 Lucy Johnson ML20211L855 FL1 Joan Rieck ML20211L855 FL1 Connie Hammond ML20211L855 FL1 Michael Hill ML20211L855 FL1 Carolyn Croom ML20211L855 FL1 Gail Sullivan (1) ML20211L855 FL1 Jonathan Mansell ML20211L855 FL1 Vicky Viray ML20211L855 FL1 Gail Sullivan (2) ML20211L855 FL1 Paul Bramscher ML20211L855 FL1 Kathryn Atkins ML20211L855 FL1 Mary Morell (1) ML20211L855 FL1 Bob Ehmann ML20211L855 FL1 Anne Ehmann ML20211L855 FL1 Kevin Brown ML20211L855 FL1 Elizabeth Lyle ML20211L855 FL1 Keith Augusto ML20211L855 FL1 Martha Fait ML20211L855 FL1 Valery Keramaty ML20211L855 FL1 Tim Rose ML20211L855 FL1 Amanda Bradley ML20211L855 FL1 Allison Kiser ML20211L855 FL1 Virginia Sendor ML20211L855 FL1 Kathleen Findlay ML20211L855 FL1 Walter Hays ML20211L855 FL1 Ellen Leaman ML20211L855 FL1 Leigh Hill ML20211L855 FL1 A-33

ADAMS Submission Submission Name Accession No. Abbreviation Ruth Lovinsohn (3) ML20211L855 FL1 Ruth Lovinsohn (4) ML20211L855 FL1 Robert Kolodny (1) ML20211L855 FL1 Robert Kolodny (2) ML20211L855 FL1 Rick Wood ML20211L855 FL1 Earl Hall ML20211L855 FL1 Robert Nobrega ML20211L855 FL1 Sharon Burge ML20211L855 FL1 Dennis Nelson (2) ML20211L855 FL1 Terri Reischl ML20211L855 FL1 Nancy Chismar ML20211L855 FL1 Jo Roehrig ML20211L855 FL1 Amit Shoham ML20211L855 FL1 Genevieve Miller (1) ML20211L855 FL1 Geooge Jacobson ML20211L855 FL1 Stephen Blakely ML20211L855 FL1 Loan Tran ML20211L855 FL1 Hugh Moore ML20211L855 FL1 Lee Miller ML20211L855 FL1 Dirk Rogers ML20211L855 FL1 Dan & Ann Green ML20211L855 FL1 Vince L. ML20211L855 FL1 Catherine Clifton ML20211L855 FL1 Mike Hlat ML20211L855 FL1 Helen Cotton ML20211L855 FL1 Michele Johnson ML20211L855 FL1 Ms. Lucy M. Almasy ML20211L855 FL1 Janice Keiserman ML20211L855 FL1 Sara Eldridge ML20211L855 FL1 Lisa Roberts ML20211L855 FL1 Sam Miller ML20211L855 FL1 Querido Galdo ML20211L855 FL1 Susan Sporl ML20211L855 FL1 Jessica Fielden ML20211L855 FL1 Carolyn Thomas ML20211L855 FL1 Erin Znidar ML20211L855 FL1 Janice Kurkoski ML20211L855 FL1 Alvaro Luque ML20211L855 FL1 Scott Sklar ML20211L855 FL1 Mary Smith ML20211L855 FL1 Sam Todd ML20211L855 FL1 Mary Jane Williams ML20211L855 FL1 Jay Jensen ML20211L855 FL1 Heather Rabinowitz ML20211L855 FL1 Paul Kerman ML20211L855 FL1 Mukund Sharma ML20211L855 FL1 Catherine Tinney Rome ML20211L855 FL1 A-34

ADAMS Submission Submission Name Accession No. Abbreviation Rita DeMaria ML20211L855 FL1 Sholey Argani ML20211L855 FL1 Thomas Fukuman ML20211L855 FL1 Robert Bamford ML20211L855 FL1 Eugene Majerowicz ML20211L855 FL1 Heidi Holloran (1) ML20211L855 FL1 Heidi Holloran (2) ML20211L855 FL1 Mary Hicklin ML20211L855 FL1 Megan Roemer ML20211L855 FL1 James Hipp ML20211L855 FL1 Courtney Hein ML20211L855 FL1 John Markham ML20211L855 FL1 Julie McCarthy ML20211L855 FL1 Cheryl Eames ML20211L855 FL1 Allen Elliott ML20211L855 FL1 Karen Larsen (1) ML20211L855 FL1 Karen Larsen (2) ML20211L855 FL1 Steve Walsh ML20211L855 FL1 James Michael "Mike" Henderson ML20211L855 FL1 Alan Murakski ML20211L855 FL1 Victor Nepomnyashchy ML20211L855 FL1 Liz Murphy ML20211L855 FL1 Kathy Svendsen ML20211L855 FL1 Harry Corsover ML20211L855 FL1 Francisco J. Velez ML20211L855 FL1 Forest Frasieur ML20211L855 FL1 Millie Magner ML20211L855 FL1 Louisa Hamachek ML20211L855 FL1 Judith Brickman ML20211L855 FL1 Mary King ML20211L855 FL1 Lee Greenawalt (2) ML20211L855 FL1 Theo Giesy ML20211L855 FL1 Linda Massimo ML20211L855 FL1 Stephen Molk ML20211L855 FL1 Trish McPeak-LaRocca ML20211L855 FL1 Kathryn Lemoine ML20211L855 FL1 Sue Jackson ML20211L855 FL1 Susan Armistead ML20211L855 FL1 Dewey Jackson ML20211L855 FL1 Elaine Heathcoat ML20211L855 FL1 Russell Jackson ML20211L855 FL1 Dominic Melita ML20211L855 FL1 Nancy Currah (2) ML20211L855 FL1 Jeff Stone ML20211L855 FL1 Mark Drye ML20211L855 FL1 Carolyn Massey (2) ML20211L855 FL1 Joyce Dixon ML20211L855 FL1 A-35

ADAMS Submission Submission Name Accession No. Abbreviation T. Garmon (2) ML20211L855 FL1 Neil Resico ML20211L855 FL1 Kathrine Jones ML20211L855 FL1 Sue Geurkink ML20211L855 FL1 Linda Abbott ML20211L855 FL1 Tina Ann ML20211L855 FL1 Joanne Groshardt ML20211L855 FL1 George Riggs ML20211L855 FL1 Richard Curry ML20211L855 FL1 Steve Donoso ML20211L855 FL1 Ryk Diemert (2) ML20211L855 FL1 Yvette Tapp ML20211L855 FL1 Harold & Lorraine Panciera ML20211L855 FL1 Suzanne J. Arnold ML20211L855 FL1 Jalna Hanmer (1) ML20211L855 FL1 Rachel Krucoff ML20211L855 FL1 Emily Willoughby ML20211L855 FL1 Cammy Colton ML20211L855 FL1 Mary Wueste ML20211L855 FL1 Eric Britton ML20211L855 FL1 Richard Fehr ML20211L855 FL1 Ellen MacRae ML20211L855 FL1 Thomas Simon ML20211L855 FL1 Martin Margolis ML20211L855 FL1 Mark Farris ML20211L855 FL1 Natalie Van Leekwijck ML20211L855 FL1 Brian Skaggs ML20211L855 FL1 Barry Eshkol Adelman ML20211L855 FL1 Laura Vera ML20211L855 FL1 Patricia Long ML20211L855 FL1 Judy Mouradian ML20211L855 FL1 Rebecca Procter ML20211L855 FL1 Fiona Priskich ML20211L855 FL1 Joann Ramos ML20211L855 FL1 Janice Wilfing ML20211L855 FL1 Keth Luke ML20211L855 FL1 Lydia Garvey ML20211L855 FL1 Chuck Graver ML20211L855 FL1 Rob Doucette ML20211L855 FL1 H. Richard Leuchtag ML20211L855 FL1 Sheridan Phillips (1) ML20211L855 FL1 Sheridan Phillips (2) ML20211L855 FL1 Joann Koch ML20211L855 FL1 Sasha Jackson ML20211L855 FL1 Curtis Eckstein ML20211L855 FL1 Dennis Kreiner ML20211L855 FL1 David Martin ML20211L855 FL1 A-36

ADAMS Submission Submission Name Accession No. Abbreviation Russell Novkov ML20211L855 FL1 Randy Vannoy ML20211L855 FL1 Mina Blyly-Strauss ML20211L855 FL1 Marcia Evers ML20211L855 FL1 Joyce Follingstad ML20211L855 FL1 Maria Baum ML20211L855 FL1 John Kirchner ML20211L855 FL1 Linda Levin ML20211L855 FL1 Marion Tidwell ML20211L855 FL1 Aimee Arceo ML20211L855 FL1 Boguslaw Kulesza ML20211L855 FL1 Kenneth Albright ML20211L855 FL1 Lee Jurman ML20211L855 FL1 Isabel Cervera ML20211L855 FL1 Ann Malyon (3) ML20211L855 FL1 Roy Taylor ML20211L855 FL1 Bettie Reina ML20211L855 FL1 Jennifer Rials ML20211L855 FL1 Meryle A. Korn ML20211L855 FL1 Wendy Alberg ML20211L855 FL1 Jalna Hanmer (2) ML20211L855 FL1 James Perkins ML20211L855 FL1 Tom Hazelleaf ML20211L855 FL1 Renee Austin ML20211L855 FL1 Ron Johnson ML20211L855 FL1 Sophia Sutton ML20211L855 FL1 Pamela Nelson ML20211L855 FL1 Joyce R. Farber (1) ML20211L855 FL1 Elizabeth Smith ML20211L855 FL1 Les Forman ML20211L855 FL1 Chanda Farley ML20211L855 FL1 Joyce R. Farber (2) ML20211L855 FL1 Penny Dever-Reynolds ML20211L855 FL1 Kathryn Rose ML20211L855 FL1 Robert Marcus ML20211L855 FL1 Carol Ann Brady, R.N. ML20211L855 FL1 Michael Gorr ML20211L855 FL1 Adrienne Hochberg ML20211L855 FL1 Eva Coffee ML20211L855 FL1 Paul Wright ML20211L855 FL1 Linda Torrel ML20211L855 FL1 Bonnie Howard ML20211L855 FL1 Gavin Bornholtz ML20211L855 FL1 Karin Ascot ML20211L855 FL1 Gail and John Richardson ML20211L855 FL1 Deborah Sallee ML20211L855 FL1 Isabel Cordova ML20211L855 FL1 A-37

ADAMS Submission Submission Name Accession No. Abbreviation Richard Trela ML20211L855 FL1 Mira Nakashima ML20211L855 FL1 Debra Stoleroff (2) ML20211L855 FL1 Kenneth Mayers ML20211L855 FL1 Shari Galve ML20211L855 FL1 J. Holley Taylor ML20211L855 FL1 Jaremy Lynch ML20211L855 FL1 Cletus Stein ML20211L855 FL1 Kathleen Mezoff ML20211L855 FL1 Eric Jacobs ML20211L855 FL1 Linda Musmeci Kimball ML20211L855 FL1 Lucy Calvillo ML20211L855 FL1 Mark Fitzgerald ML20211L855 FL1 Robert Schuessler ML20211L855 FL1 Stephanie Bilenko ML20211L855 FL1 Ilene Bellerue ML20211L855 FL1 Gudrun Dennis ML20211L855 FL1 Anje Waters ML20211L855 FL1 Nancy Roberts-Moneir ML20211L855 FL1 Sharon Fortunak ML20211L855 FL1 Nancy Bodan-Gonser ML20211L855 FL1 Evan Ravitz ML20211L855 FL1 Joanne Tenney ML20211L855 FL1 Carol Jurczewski ML20211L855 FL1 Laura Leipzig (2) ML20211L855 FL1 Silvia Hall ML20211L855 FL1 Susan Kulis ML20211L855 FL1 Astrata Barber (2) ML20211L855 FL1 Amaryntha Schalin (2) ML20211L855 FL1 Lisa Hammermeister ML20211L855 FL1 Robin Cook ML20211L855 FL1 Morey Wolfson ML20211L855 FL1 Teri Raymond ML20211L855 FL1 Judith Hutchison ML20211L855 FL1 Mariane Paviasen ML20211L855 FL1 Glenn Mitroff ML20211L855 FL1 Leonard Tremmel ML20211L855 FL1 Abigail Gindele ML20211L855 FL1 Harvey Dym ML20211L855 FL1 Carl Arnold ML20211L855 FL1 John Rath ML20211L855 FL1 Grant Rich ML20211L855 FL1 Charlotte Mullen ML20211L855 FL1 Dave Parrish (2) ML20211L855 FL1 Janet Geldert ML20211L855 FL1 Kevin Havener ML20211L855 FL1 Ronit Corry ML20211L855 FL1 A-38

ADAMS Submission Submission Name Accession No. Abbreviation Joseph Goldenberg ML20211L855 FL1 Charles Happel ML20211L855 FL1 Gabrielle Kayser ML20211L855 FL1 Roberta Ahlquist ML20211L855 FL1 Patrick J. Mitchell ML20211L855 FL1 Sandra Marr ML20211L855 FL1 Douglas and Diane Ower ML20211L855 FL1 Alice Neuhauser ML20211L855 FL1 Thomas Conroy ML20211L855 FL1 Eva Linderoth ML20211L855 FL1 Lee Bartell ML20211L855 FL1 Heidi Buitron ML20211L855 FL1 Terrence Bennett ML20211L855 FL1 Michele Hale ML20211L855 FL1 Lore Weber ML20211L855 FL1 R.G. Tuomi ML20211L855 FL1 Christiane Bernier ML20211L855 FL1 Richard Koerber ML20211L855 FL1 Mary Heiser ML20211L855 FL1 Ernie Loreen ML20211L855 FL1 Dale Axelrod ML20211L855 FL1 Lawrence Crowley ML20211L855 FL1 Sharon Hurley ML20211L855 FL1 Ken Gibb ML20211L855 FL1 Lynne Preston ML20211L855 FL1 Meredith McGuire ML20211L855 FL1 Mary Long ML20211L855 FL1 Sherrill Lewis ML20211L855 FL1 James Sliger ML20211L855 FL1 Katharine Tussing ML20211L855 FL1 Laurie Litman ML20211L855 FL1 Gloria Lewis ML20211L855 FL1 Jan Mosgofian ML20211L855 FL1 Gregory Pais ML20211L855 FL1 Edward Petroski ML20211L855 FL1 Terry Warkentine ML20211L855 FL1 Nancy Harlow ML20211L855 FL1 Lucy Nichols ML20211L855 FL1 Andrei Harabadji ML20211L855 FL1 Tom Devine ML20211L855 FL1 William St. George ML20211L855 FL1 Marilyn Long ML20211L855 FL1 Robert Tinsley ML20211L855 FL1 Martin Russell ML20211L855 FL1 Kelly DeVine ML20211L855 FL1 Eve Duddy ML20211L855 FL1 Elaine Larson ML20211L855 FL1 A-39

ADAMS Submission Submission Name Accession No. Abbreviation Nathalie Kuroiwa-Lewis ML20211L855 FL1 Elizabeth Kelley ML20211L855 FL1 Stephanie Huntington ML20211L855 FL1 Bret Myers ML20211L855 FL1 Emma Goode-DeBlanc ML20211L855 FL1 Glenn Knoblock ML20211L855 FL1 Kathy Oppenhuizen (1) ML20211L855 FL1 John Robert Jackson ML20211L855 FL1 Robert Quarrick ML20211L855 FL1 Jean Glassman ML20211L855 FL1 Thomas A. Pakurar ML20211L855 FL1 Roberta Marine ML20211L855 FL1 Judith Butts ML20211L855 FL1 Ann Breitenbach ML20211L855 FL1 Ken Bossong (2) ML20211L855 FL1 Paul Reslink ML20211L855 FL1 Peggy Fugate ML20211L855 FL1 Laurie King ML20211L855 FL1 Bruce Ross ML20211L855 FL1 Martin Mador ML20211L855 FL1 Jonny Hahn ML20211L855 FL1 William Wharton Smith III ML20211L855 FL1 Lucymarie Ruth ML20211L855 FL1 Lori Haaland ML20211L855 FL1 Yvonne Fisher ML20211L855 FL1 Saab Lofton ML20211L855 FL1 Gabriela Sweet ML20211L855 FL1 Matthew Shapiro ML20211L855 FL1 Karl Novak ML20211L855 FL1 Karma Lekshe Tsomo ML20211L855 FL1 Sharon Fasnacht ML20211L855 FL1 Dennis Nelson (3) ML20211L855 FL1 Manuel Bermudez ML20211L855 FL1 Sarah Hayes ML20211L855 FL1 Jacki Gluck ML20211L855 FL1 Wayne English ML20211L855 FL1 Edith Ogella ML20211L855 FL1 Lloyd Hedger ML20211L855 FL1 Nan Wollman ML20211L855 FL1 Victor Becker Lau ML20211L855 FL1 Dorothy Anderson ML20211L855 FL1 Zeb Nole ML20211L855 FL1 Ric Bernat ML20211L855 FL1 Elaine Palmquist ML20211L855 FL1 Erline Towner ML20211L855 FL1 Sylvia Tyree ML20211L855 FL1 Sally Mann ML20211L855 FL1 A-40

ADAMS Submission Submission Name Accession No. Abbreviation Jann Brooks (1) ML20211L855 FL1 Jann Brooks (2) ML20211L855 FL1 Kaelan Shannon ML20211L855 FL1 Michael Daus ML20211L855 FL1 Carole Huelsberg ML20211L855 FL1 Larry Gioannini ML20211L855 FL1 Albert Ulrich ML20211L855 FL1 John Keiser ML20211L855 FL1 Nancy Griffith ML20211L855 FL1 Joyce Case ML20211L855 FL1 John Thompson ML20211L855 FL1 B Barbara Parliman ML20211L855 FL1 Marie Young ML20211L855 FL1 Elliott Blass ML20211L855 FL1 Loraine Ferrara ML20211L855 FL1 Randall Frank ML20211L855 FL1 Susan Clark ML20211L855 FL1 Sandra Cais (3) ML20211L855 FL1 L. Sokei ML20211L855 FL1 Dawn Florio ML20211L855 FL1 Karen Verrill ML20211L855 FL1 Carolyn Summers ML20211L855 FL1 Pauline Cunningham ML20211L855 FL1 Robert Fenstermaker ML20211L855 FL1 Sandra Benzeev ML20211L855 FL1 Lisa Vaughan ML20211L855 FL1 Aileen McEvoy ML20211L855 FL1 Carol Edwards ML20211L855 FL1 Nicholas Williams ML20211L855 FL1 Helen Rynaski ML20211L855 FL1 Joan Liberty ML20211L855 FL1 Terry Akana ML20211L855 FL1 A. Gardner ML20211L855 FL1 Lynn Pekkanen ML20211L855 FL1 Mary Perner ML20211L855 FL1 Chip Henneman ML20211L855 FL1 William McGoldrick ML20211L855 FL1 Liz Rieman ML20211L855 FL1 Joy Morgen ML20211L855 FL1 Mike Sheppard ML20211L855 FL1 Vernon Brechin ML20211L855 FL1 Lowell Young (1) ML20211L855 FL1 Lowell Young (2) ML20211L855 FL1 William Palmisano ML20211L855 FL1 Oleh Sydor (2) ML20211L855 FL1 Diana Horowitz ML20211L855 FL1 Richard Foreman ML20211L855 FL1 A-41

ADAMS Submission Submission Name Accession No. Abbreviation Jesse Marsden ML20211L855 FL1 Stuart Weinstock ML20211L855 FL1 Victoria Fuller ML20211L855 FL1 P.Jacquelyn Schmidt ML20211L855 FL1 Peter Guerrero ML20211L855 FL1 Fergus Marshall ML20211L855 FL1 David Ball ML20211L855 FL1 Jonna Johnson ML20211L855 FL1 Shirley Rice (1) ML20211L855 FL1 Shirley Rice (2) ML20211L855 FL1 Robin Jenkins ML20211L855 FL1 Shay Coleman ML20211L855 FL1 Stephen Battis ML20211L855 FL1 Denise Dreher ML20211L855 FL1 Ron Katz ML20211L855 FL1 Thomas Dorsey ML20211L855 FL1 Carolyn Turner ML20211L855 FL1 Caroline Miller ML20211L855 FL1 Roderick Jude ML20211L855 FL1 Kathy Faris ML20211L855 FL1 Robin Mcfall ML20211L855 FL1 Stephen Schwartz ML20211L855 FL1 Jami Pillow ML20211L855 FL1 Teresa Grady Sayvetz ML20211L855 FL1 Michael Ahern ML20211L855 FL1 Mike Coats ML20211L855 FL1 Donna Pope ML20211L855 FL1 Don Schwartz ML20211L855 FL1 Bruce Donnell ML20211L855 FL1 William Persky ML20211L855 FL1 Georgia Braithwaite ML20211L855 FL1 Benjamin Martin ML20211L855 FL1 BK Young ML20211L855 FL1 Melissa Lowe ML20211L855 FL1 Deborah Childers ML20211L855 FL1 Patricia Constantino ML20211L855 FL1 Joan Mccoy ML20211L855 FL1 Janet Maker (2) ML20211L855 FL1 Kathleen Corbett ML20211L855 FL1 Linda Wood ML20211L855 FL1 Elizabeth Williams ML20225A219 FL1 Kathy Oppenhuizen (2) ML20225A219 FL1 Mary Morell (2) ML20225A219 FL1 Kaitlin Fitch ML20225A219 FL1 John Dervin ML20225A219 FL1 Carolyn Poinelli (1) ML20225A219 FL1 Carolyn Poinelli (2) ML20225A219 FL1 A-42

ADAMS Submission Submission Name Accession No. Abbreviation Sylvia Rodriguez ML20225A219 FL1 Danny Dyche ML20225A219 FL1 Susan Cox ML20240A274 FL1 Jana Shiloh ML20240A274 FL1 Laura Miner ML20240A274 FL1 Pia Jensen ML20240A274 FL1 Susan Yeske ML20240A274 FL1 Sharon Crocker ML20272A243 FL1 Kay Brainerd (2) ML20272A243 FL1 Genevieve Miller (2) ML20272A243 FL1 Kevin Klenner ML20272A243 FL1 Michelle Buerger ML20272A243 FL1 Colleen Bonniwell ML20272A243 FL1 Kevin Klenner ML20290A748 FL1 Jeannie Pollak ML20337A375 FL1 Dr. F. Taylor ML20192A263 FL1 Mindy Maxwell ML20204B011 FL1 Jim Head ML21131A175 FL1 Charlie Croizet ML20272A286 FL2 Renata Baron ML20272A286 FL2 Michael Gavin ML20272A286 FL2 Emma Redfoot ML20272A286 FL2 Daniel Rosales ML20272A286 FL2 Wayne Keith ML20272A286 FL2 Nicholas Houze ML20272A286 FL2 Michael Mudawar ML20272A286 FL2 Ashley Hoover ML20272A286 FL2 Liz Harney ML20272A286 FL2 Shaffer ML20272A286 FL2 Tao Flaherty ML20272A286 FL2 Lynne Van Slyke ML20272A286 FL2 Bryan Barnard ML20272A286 FL2 Brian Fischer ML20272A286 FL2 Mike Kleckner ML20272A286 FL2 Billy Groom ML20272A286 FL2 Mickey Davis ML20272A286 FL2 Ernestine Kuhr ML20272A286 FL2 Eric Uhrhane ML20272A286 FL2 Benjamin Leopardo ML20272A286 FL2 Dr. Erik Walker ML20272A286 FL2 Tori Riso ML20272A286 FL2 A-43