ML18302A341
| ML18302A341 | |
| Person / Time | |
|---|---|
| Issue date: | 10/29/2018 |
| From: | NRC/OCIO |
| To: | |
| References | |
| FOIA, NRC-2019-000050 | |
| Download: ML18302A341 (37) | |
Text
Rulemaking for Emergency Preparedness for Small Modular Reactors and Other New Technologies RIN Number: 3150-AJ68 NRC Docket ID: NRC-2015-0225 Regulatory Basis-Draft Document for Public Comment April 2017 ML16309A332
ABSTRACT Current emergency preparedness (EP) regulations do not reflect the advances in reactor designs and more recent reactor safety research, particularly with respect to small modular reactors (SMRs) and other new technologies (ONTs}, such as non-light-water reactors (non-LWRs). The U.S. Nuclear Regulatory Commission (NRC) staff requested permission from the Commission to conduct rulemaking to address this issue. This document provides the regulatory basis for a proposed EP rule for SM Rs and ONTs. It explains the current EP framework for large light-water reactors, describes regulatory issues that have motivated rulemaking for SMRs and ONTs, presents a potential alternative to rulemaking, and summarizes the background documents related to these issues. The staff is considering a proposed EP rule, which is applicable only to SMRs and ONTs. The rule is inte~ded to be consequence-oriented, performance-based, and technology-inclusive. The rule wilJ.provide for reasonable assurance of adequate protection of public health and safety.
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EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis ii April2017
CONTENTS ABSTRACT.............................................................................................................. :..... iii ABBREVIATIONS AND ACRONYMS........................................................... :................. v
- 1.
INTRODUCTION........................................... :.....................................,.... 1-1 1.1 1.2
- 2.
2.1 2.2 2.3
- 3.
3.1 3.2 3.3 3.4 3.5 3.6
- 4.
4.1 4.2 Scope of Document.............. :.............,...................................................... 1-1 Background.............................................................................................. 1-1 EXISTING REGULATORY FRAMEWORK.............................................. 2-1
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The NUREG-0396 Methodology *************~**.~...... :....................................... 2-1
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Current EP Regulations.......................,:.......,........................................... 2-3
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Guidance Documents....................... <.... :~... ::*:;... :...................................... 2-4 REGULATORY ISSUES.......... !........................ :-...................................... 3-1 Size of the EPZ and Other Offsite EP Requiremen'ts,...*.......................... 3-1 Source Term, Dose Calculati~'n~. ar:id Siting.... ;.......... >
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Operator Staffing..... ;:................... *::-..... ;.,::'.....,.-..................... *>~,...*............... 3-2
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Co-Location of Facilities.. ::-;............... :*:;-.... :............................................... 3-2 Multi-module Facilities';...... :*:.-:.... ;:.,............ :* *....*......................................... 3-2
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Perform~tme-Bc!sed Appr<:>a~h to* E~erg_E:mcy'*preparedness................... 3-3
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REGYlATORY.~P~ROACt::t\\E~/(.:._._..:-:.-.~.,:*::**:*,:;**::................................... 4-1 Option { * ~xemptipn~ and Gu.!dance........... ::*........................................... 4-1 Option 2> Con.du~t Rulernakini(...............-............................................... 4-1
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4.3,./... Co11~!us1pns.. :*.~*.:.***_;...... ::-~..,::.:.. **~:~:*\\*,~-******************************************************** 4-5
- 5.
OTHERREG_ULA~ORY CONSlpERATIONS.......................................... 5-1
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5.1
. Cost and Impact Considerations.............................................................. 5-1
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5.1.1
- Introduction.... \\...-......... ::-:........................................................................... 5-1
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5.1.2 Potential Effect 0n Licensees.. :................................................................ 5-2 l
5.1.3 Potenticf Effect.on. Offsite Governmental Organizations........................... 5-5 5.1.4 Potential'Effect ori the NRG...................................................................... 5-5 5.1.5 Cost Justification...................................................................................... 5-6 5.2 Backfitting and Issue Finality.................................................................... 5-7 5.3 Cumulative Effects of Regulation.............................. :.............................. 5-8 5.4 Environmental Analysis............................................................................ 5-8 5.5 NRG Strategic Plan........,..........................................................................--5-8 5.6 Regulatory Flexibility Act.......................................................................... 5-9
- 5. 7 Peer Review of Regulatory Basis.............................................................. 5-9 EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis iii April 2017
- 6.
STAKEHOLDER INTERACTIONS........................................................... 6-1 6.1 Past Interactions ********************************************************************************~***** 6-1 6.2 Questions for Public Comment................................................................. 6-2
- 7.
NEXT STEPS........................................................................................... 7-1 7.1 Steps toward Rulemaking........................................................................ 7-1 7.2 Future Guidance Documents................................................................... 7-1
- 8.
REFERENCES............,............................................................................ 8-1
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EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis iv April 2017
ABBREVIATIONS AND ACRONYMS 10 CFR CER OBA DOE EOF EP EPZ EPA ERO ETE FEMA FR HTGR km LWR mSv NEI non-LWR NPV NRC NUMARC NUREG ONT ORO PAG PANS PRA rem
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Title 10 of the Code of Federal Regulations cumulative effects of regulation design-basis accident U.S. Department of Energy emergency operations facility emergency preparedness emergency planning zone U.S. Environmental Protection Agency emergency response organization
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evacuation time estimate
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Federal Emergency Management Agency/
Federal Register
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high-temperature, gas-cooled reactor ',_
kilometer or 1000 meters
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light-water reactor
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millisievert, 0.001 of a Sievert\\
Nuclear Energy Institute
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non-light-water reactor
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net present value 1/
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U.S. Nuclear Regulatory.Commission *-,,,
Nuclear Utilities Management *and Resources 'Council reports or brochures on* reg1,.1lator:y'aecisions>re~ul~s of research, results of incident inyestigations and, other techriical.and administrative information published, by t~e Nµclear R'egulatory,Con:iniission.'***,. ':
other. new tech.nology
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offsite, ~esponse o?ganization \\. '... *
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protective action gu'ide
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// r?._r~babili.stiC 'risk as.sessme.(11'. *.
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I REP roentgen equivalent man, the*c~ntimeter-gram-second system unit of equivalent dose, effective dose and committed dose
. radiological**emergency pr~paredness
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- , -~eactor Oversig 1ht*process-*
small modular reactor research and te~t reactor Secreti:1~**0f t~8 co'mmission SHINE Me~fcal Technologies, Inc.
staff requirements memorandum structure, system, and component Sievert, the metric system unit of dose equivalent or the biological effect of ionizing radiation total effective dose equivalent Three-Mile Island used generically to refer to the 1979 Three-Mile Island accident EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis V
April 2017
- 1. INTRODUCTION Current emergency preparedness (EP) regulations do not adequately address the advances in reactor designs, reactor safety research, and their applications to small modular reactors (SMRs) and other new technologies (ONTs). The NRC staff obtained permission from the Commission to conduct rulemaking to address EP for SMRs and ONTs applying the advances in reactor designs and reactor safety research. The purpose of this document is to inform and provide an opportunity for stakeholders to participate in the rulemaking process, consistent with the NRC's Principles of Good Regulation: Independence, Openness, Efficiency, Clarity, and Reliability. This document provides the regulatory basis for a proposed EP rule for SM Rs and ONTs. It explains the current EP framework for large light-wafer reactors, describes regulatory issues that have motivated rulemaking for SMRs and oNrs: a11d summarizes the background documents related to these issues.
1.1 Scope of Document
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The scope of this document encompasses EP for. SM Rs and ONTs dnJy.. Emergency planning, preparation, and response for large light-watek...reactors (LWRs), fuel cyele*facilities, research and test reactors (RTRs }, and other non-power; *noncpmmer:eial. facilities are nqt within the scope of this regulatory basis docum_ent and subseq~ent Jtilemaking. FurtherQ10r:e, the application of the proposed rule woyld be li_mited to SMJ~ a~.d-ONT facilities.
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Section1 1 of this regulatory basis sumh:Jarizes)he background af)d developments leading to this rulemal<ing. Section 2 details the existihg E;P regt,Jlatory frani'ewor~ applicable to large LWRs, and guidance documents:-Section 3 des*cribes the*nJajor issuesthathave led to movement toward EP rulemakin.g for SMR_s and ONT~;. Sectjoh 4 de~cribes the rulemaking that will reduce or eliminate the issu*~s described in Section 3, ana d_iscusses-~ri alternative to rulemaking.
Section 5 includes th*e.pfh~r regul~tory conside(ati_ons relating fo the development of the new rule. Section 6 discusses_ sta.keh9lder t!"lteractio'ns and includes questions for stakeholders to consider w_hile providing con,ments. __ S~ectioo 7 dfs~usses the next steps that need to be tak.en toward rulemaking,_as well as-.technicalaspects that will need to be addressed in new guidance docume'nts. ReferencS:s appear -in* Section a*:,.. -* "*
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1.2 *,**,.Background*** * *
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After the U.S. deployment of large LWRs spanning the 1950's through the 1990's, the U.S. and other countries dev_e*loped and promoted many different designs, such as sodium-cooled reactors, heavy-water-moderated reactors, gas-cooled reactors, and evolutionary LWR designs with passive design features*:, A$ the industry proposed new and innovative reactor designs, the staff considered the need to modify EP requirements. The new designs typically have lower probabilities of severe accidents, and SMRs have smaller radiological source terms because they are lower in power or have special design features.
More recently, new reactor designs being developed and promoted include light-water SM Rs, such as the integral pressurized-water reactor design from NuScale. Some advanced reactor designs do not use light water as a coolant or a moderator but instead are gas-cooled, liquid-metal-cooled, or molten-salt-cooled. Furthermore, some medical isotope production facilities use a fission process either within a reactor or from an accelerator target. Collectively, the designs discussed in this paragraph are considered either SMRs or ONTs. Their smaller size or innovative safety features are likely to lead to lower risk or less demanding accident EP for SMRs. and ONTs Rulemaking: Draft Regulatory Basis 1-1 April 2017
conditions, motivating reconsideration of the EP requirements that were developed to support the large LWRs in operation today.
In response to these various designs, the staff engaged the Commission on associated issues.
ln.SECY-93-092, "Issues Pertaining to the Advanced Reactor (PRISM, MHTGR, and PIUS) and CANDU 3 Designs and Their Relationship to Current Regulatory Requirements," dated April 8, 1993 (NRC's Agencywide Documents Access and Management System (ADAMS) Accession No. ML040210725), the staff suggested that there be no change to existing regulations governing EP for advanced reactors and stated that regulatory direction would be given at or before the start of the design certification phase in such a way that design implications for EP could be addressed.
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In SECY-97-020, "Results of Evaluation of Emergency ~1a*nniog for Evolutionary and Advanced Reactors," dated January 27, 1997 (ADAMS Accessi9.n No. f0[992920024), the staff stated:
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Because industry has not petitioned for c!;lang~s to EP req1,1irements for evolutionary and passive advanced LVVRs [light-water reactb~s], the staff did not dedicate the resources to fully evalua(e th_ese issues. The staff.rem.ains receptive to industry petitions for change~ to EP requ~~ments foh~yolutionary and passive advanced LWRs.
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By 2004, performance-based EP became important for-existing large LWR plants. In SRM-SECY-04-0236, "Staff Requirern,ents~SE~Y-04-023p~_Southern Nuclear Operating Company's Proposal To Establish a Cornn:ion-E,riiergency Op~rating Facility at its Corporate Headquarters," dated Feb~uary 23, 2005\\(ADAMS ~ccession No. ML050550131), the Commission recogniz~d*the concept of per:formance'based ~P: '*, __ **
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The staff should *Gonsider"~evi,sing 1 o CFR Part 50 to 'rnal<e the requirements for EOFs [emergehcy"operatiqns:facilitiesJ\\nore performance-based to allow other multi_-p!c:1.n! licensee~ to cpnsolidate their EpF.s, if those licensees can d~monstrate th_eir em~rgency response strategies will adequately cope with an emergency at ariy. of tn'e associated pl.ants. \\- '
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- I In SECY-..06-0200, "Results, of the Review of Emergency Preparedness Regulations and Guidance,"dated Septembek,20, 2006 (ADAMS Accession No. ML061910707), the staff sought Commission approval to explore the feasibility of a voluntary, performance-based EP regulatory regimen. Specifi~ally, the staff,,~tated:
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[A]s the EP program has matured and industry performance has improved, the staff recognized*th,e benefits of a performance-based regulatory structure. Thus, the staff is proposing a *new voluntary performance-based regulatory regimen.
The staff has conceptualized the basis for a voluntary performance-based EP regulatory regimen... This regimen could be adopted in lieu of the existing EP regulations contained in 10 CFR Part 50. The current regimen tends to emphasize compliance with, and control over, emergency plans and facilities.
The performance-based regimen would focus licensee efforts on actual performance competencies, rather than control of emergency plans and procedures. Regulatory oversight would focus on licensee performance, instead of licensee processes and procedures. Creating a performance-based EP regulatory regimen could achieve a higher level of preparedness, as the regimen would focus on results and abilities rather than on means. The EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 1-2 April 2017
performance-based regimen would provide the NRC with enhanced oversight of the actual competencies important to protection of public health and safety while allowing licensees increased flexibility.
In SECY-06-0200, the staff outlined several high-level concepts:
The staff would develop a set of overarching performance goals to guide the design of the performance-based framework.
- The on-shift emergency response organization (ERO) would perform many competencies necessary for emergency response. /~,
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The augmented EROs would perform the emerger\\cy re'sponse competencies specific to the emergency response facility.
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The staff would develop performance inqicators that woula,monitor:
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drill and exercise performancel~
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ERO participation
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ERO activation and ~eportir:ig timelines.
success during emerg~ncy *drills I
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The NRC's "Policy Statement on the R~gulation*of Advanc~d,~eactors" (73 FR 60612; October 14, 2008) states that advanced reactor designers should consider the expectations in the policy statement to ensure)hat security ?n~ ery,ergency response are considered alongside safety during the early stages of*plant design\\.. /
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In SECY-10-0034, "Pote~tial.Poli9~. lic_~nsing:\\(lct.Key Technical Issues for Small Modular Nuclear R~actorDe~igns," dated'MarJ;:_h 28, 2010\\(ADAMS Accession No. ML093290268), the staff identified.that_EP was a* key technicaLis'sue for,)icensing SMRs.
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Follo~ing"p\\Jblic meeti~'gs with industry and s;;keholders, and a review of other SMR issues, the staff is$ued SECY-11-0152,"Devel_opment of an Emergency Planning and Preparedness Framework 'fo[ Small Modular \\Reactors/. dated October 28, 2011 (ADAMS Accession No. ML112570439) *. This paper dis,cu~sed "the staffs intent to develop a technology-neutral, dose-based, conseque*nce--oriented EP framework for SMR sites that takes into account the various designs, modularity'ard colocatio~*. as well as the size of the EPZ." It also stated that the "staff will work with stakeholders.to'clevelop general guidance on calculating the offsite dose, and is anticipating that the industry will develop and implement the detailed calculation method for review and approval by the**staff."
In SECY-14-0038, "Performance-Based Framework for Nuclear Power Plant Emergency Preparedness Oversight," dated September 16, 2014 (ADAMS Accession No. ML14260A078),
the staff stated:
A systematic review and revision of EP requirements to employ a more performance-based oversight regimen (regulation, inspection, and enforcement) has the potential to enhance many aspects of emergency response and oversight. A performance-based oversight regimen could simplify EP regulations EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 1-3 April 2017
and focus inspection more fully on response-related performance rather than the current focus on plan maintenance and compliance.
Although the staff asserted that the performance-based framework would simplify EP regulations and focus inspections more on response-related performance, the staff.
recommended that the existing framework continue to be used with operating plants because changing the EP approach for those plants would require significant resources for implementing a performance-based framework and could introduce regulatory risk and the existing framework, which was enhanced in 2011, continued to provide reasonable assurance.
In SRM-SECY-14-0038, "Staff Requirements - SECY-14-003J3,,..::..performance-Based Framework for Nuclear Power Plant Emergency Preparedn.ess Oversight," dated September 16, 2014 (ADAMS Accession No. ML14259A589), the Commission approved the staff's
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recommendation and specified that the staff _"be vigilapfin contin.uing to assess the NRC's emergency preparedness program and should not fl!l~.. c;>ut th~ *possibility of moving to a performance-based framework in the future. The Commission not!3s tne potential benefit of a performance-based emergency preparednessJegimen for small modular reactors, and the staff should return to the Commission if it finds tha't conditions warrant rulemaking."
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In 2015, the staff sought Commission approval td initiate rule'r~1aking to re~h,~ EP regulations and guidance for SMRs and ONTs..,In SECY-15-odn; '!Options for Emergencr Preparedness for Small Modular Reactors and Oth!3r ~ew Technologie.~," ~ated May 29, 2015 (ADAMS Accession No. ML15037A176), the stc:iffprqposed a conseguence-oriented approach to establishing requirements commensurate wfth.t_h'e**potentialc911sequence to public health and safety and the common def~_nse and security at SMR and ONTJacilities. The staff stated that the need to establish c!n*'EP frarn13work fot,SI\\IIRs ana ONTs is basep upon the projected offsite dose in the unlikely occurrerice,of'a severe '-a.cc(de6t.. In* sR,M-Sl;CY-15-0077, "Staff 1
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Requirements - SEC:'(-1 ~-0077 \\Options for,EmE;rgency Preparedness for Small Modular Reactors and Other Ne~ T~chnol9gi¢s," dated.~ugust 4, 2015 (ADAMS Accession No. ML15216A492),. the Commission-directed the staff to proceed with rulemaking.
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In SECY-16-00'697*~Rulemaking Plan on Emergency Preparedness for Small Modular Reactors and other New Techndlogie~," datl;ld May 31,-~Wt6 (ADAMS Accession No. ML16020A388), the staff proppsed a plan for EP rulemaking for SMRs and ONTs such as non-LWRs and medical isotope procluction facilities. --The proposed plan for rulemaking included the development of this regulatory basi~**d9cument. 111,SRM-SECY-16-0069, "Staff Requirements-SECY-16-0069-Rulemaking Plan,oh Emergency Preparedness for Small Modular Reactors and other New Te.chnologies," date.d June 22, 2016 (ADAMS Accession No. ML16174A166), the Commission I
approved the staffs prpposed plan.
EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 1-4 April 2017
- 2. EXISTING REGULATORY FRAMEWORK 2.1 The NUREG-0396 Methodology In 1978, a task force of NRC and U.S. Environmental Protection Agency (EPA) representatives created a technical basis for EP and published the results in 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 Plants," issued in December 1978 (ADAMS Accession No. ML051390356). The task force's report concluded that the objective of emergency response plans should be to produce dose savings}or a wide spectrum of accidents that could produce offsite doses in excess of the EPA protecJive ~ction guides (PAGs)[1]. The PAGs are reference values for radiation doses which war~pnt preselected protective actions for public protection, if the projected dose received by an individual in the absence of protective action exceeds the PAG. The task force determined tlfat tnree'elements needed to be considered in establishing requirements for EP. NLJR~G':0395'*provides the following information:
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Distance to which planning for the initiation of predetermined protective actions is t d warran e
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The task force considered tQat th~ most imp6rt~n{g1,1icfance for planni~ ~fficials is the distance from the nuclear facilitY:"Yhicl:) defines th~ ar~a over which planning for pre-
. determined actions should be \\arr1ed,p.ut. _It identifie.ftvyo types of emergency planning zones (EPZs), where each has 'a,distirict,.q_istar:,ce fromJhe.. nuclear power plant and defines a zone where advanced pl1nning is**ctone.
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- 1. A plume ~xp,o§ure pat~W~y EPz:* ./Yhere)he p.rihcipal exposure sources from this pathway ar~ (a) whole *~ody externa.1 e~posure to gamma radiation from the plume and from depq_sit~.d m~terialand (b) 'i11h'aJation exposure from the passing radioactive
,plume.<T.he pllir11e*expo§u~e patt,way*~pz is the zone in which plans for prompt or
./ u.rgent ~¢~bn~ to pr~te9t the* pubJtc* ar~ pr,~pared.
('2. An ingesti~~e~pbsu~',p~thvvay E~i-ljljhere, the principal expos_ure from this
- ,.pathway would b~ fr()m in'g~sti<;>n of contaminated water or foods such as milk or fresh yegetables. T,he ingestion* exposure pathway EPZ is the zone in which plans to prev~rit radioactive'*~aterial potentially entering the food chain.
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In developing.the recol)imendation, the task force considered several rationales for establishing ttie,sizes,.of tt{e EPZs. These rationales included the notions of risk criteria, probability limits, 'cqst effectiveness, and a spectrum of accident consequences. The task force chose to base the rationale on a full spectrum of accidents and corresponding consequences, tempered by probability considerations. The task force stated that emergency plans for large LWRs could be based on a generic distance out to which predetermined actions would provide dose savings for any such accidents.
Plume Exposure Pathway EPZ The Task Force recommended a 10-mile (16-kilometer (km)) radius for this zone largely based on source term considerations. The EPA set the PAGs as a range from 1 to 5 rem (10 millisieverts (mSv) to 50 mSv) whole body dose from external exposure and a EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 2-1 April 2017
range of 5 to 25 rem (50 mSv to 250 mSv) adult thyroid dose from radioiodine exposure.
The following criteria were used to determine the generic distance (10 miles (16 km)) for the plume exposure pathway EPZ:
The EPZ would encompass those areas in which projected dose from design-basis accidents (DBAs} would not exceed the EPA PAGs levels outside the zone.
The EPZ would encompass those areas in which the doses from less severe core damage accidents (not involving large releases of radioactive material to the environment) would not exceed the EPA PAGs outside the zone.
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t The EPZ would be of sufficient size to provi51E:f for substantial reduction in early severe health effects in the event of mor~,seve(e core melt sequence accidents (beyond-design-basis severe events w,it~ r~lea~e 9f substantial quantities of radioactive materials to the environl)'.lent).: In this.ca~e. life-threatening doses would not occur outside the zone./.
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Detailed planning for protectivfu,actlons within the 10-mhe.,(1q-km) EPZ should provide a basis for the exparisio'r1*,.@f response.,,efforts beyc:in~ the plume exposure pathway EPZ, if needed.
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The task force recommended th~ i~gestiqn ex;posure pathyi.,ay EPZ have a 50-mile (80-km) radius baseq.,,on.the expectea distance**in,tend.ed for,lpng~r-term response actions and at which ~isfanJ;~~dos~s to the\\nta,nt t9yroi<fJromJngestion of milk would not exceed the thyroid e~po~ure PAG.'for milk ing~stjen. / *, *-,, *.,
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The task force st~teq that the/detailed planning within the plume exposure pathway EPZ wou!d-provj~e a SUQ~taq,tial base tor expaqdir19 response efforts if necessary for lq.w-prof?_c!!Jility; t1igh-cqns~qLience.~venJs, from which the effects could extend beyond (the.Plume expq_sur~ pathway EPZ. Th~ task'force determined the areas in which these
'*frit~ria were met~y* eyaluat!ng'.PBA dat~dr6m licensees' final safety. analysis reports an9 *accident seque~ce,. risk;' a!1a source term data from NRC document WASH-1400 (NUR,EG,-75/014), "Repctpr Safety Study: An Assessment of Accident Risks in U.S.
Commercial Nuclear Power Plants;" issued October 1975 [2]. *
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Specifically',-t~*e-task for,be palculated (1) the release fraction from plants that exceeded EPA PAG doses bE1yond 10 miles (16 km) for DBAs, (2) the probability of exceeding various dose thresholds as a function of distance from the reactor, and (3) the benefit of various protective ~ction strategies. On the basis of these analyses, the task force recommended that emergency plans should be developed for an area within a radius of about 10 miles (16 km} from the reactor for the plume exposure pathway EPZ. Using a similar rationale and considering the expected dispersal and deposition of the radioactive material and the conversion of atmospheric iodine to chemical forms that do not readily enter the ingestion pathway, the task force selected an area within a radius of about 50 miles (80 km) from the reactor for the ingestion exposure pathway EPZ.
EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 2-2 April 2017
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Time-Dependent Characteristics of Potential Releases and Exposures The task force determined that, depending on the type of accident, a wide range of timing for releases is possible. The reactor safety study, WASH-1400, reported, for example, that major releases may begin in as short a time as 30 minutes to as long as 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> after an initiating event. The task force estimated time from the initial recognition that a serious accident is in progress to the beginning of a release of radioactive material as key information for developing emergency plans, as well as for developing the means of notifying the public of the need to take protective actions. The task force concluded that EP requirements should be ba$ed on releases that may start as early as 30 minutes following the initiation of an evenV
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Types of Radioactive Materials Potentially Released to 'the Environment
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-Emergency planners need information on,,the *!3haracteristiGs' of potential radioactive material releases to specify the characteristics of monitoring *instr_umentation, develop decision aids to estimate projected d<>$es, 'and identify critical expol:>ure modes. The task force concluded that emergency pla(l~ -!:!hould foc4s on the rel~as.e of gaseous materials and volatile solids, such as noble'.,gases a,ncf io,dine, respecttvely, because the potential for releases to the,envir~nment dedr~~sed. g.ramatically when',progressing from gaseous materials to volatile. solids to nonvolatil~ solids.
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2.2 Current EP Regulation'i;,, \\ "*.,,<.*
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10 CFR 50.47, "Emergency _ _Plam( and Apper:idix i;,,tb 1-9-cF~ Part)50, "Emergency Planning and Preparedness fpr P_roduclioQ aQd Utilization,facilities}! ~6ntc1in the regulations governing EP for current nuclear: power reactor~. Othe~*~eleyant regulations are in 10 CFR 50.54(q), (s),
and (t).
- This regulatory*.~rar,::iework r~quires eac~ hµclear power reactor licensee to establish and maintain.em.ergency"plahs c1rid preparedness.: The regulations include standards for onsite and offsi~e emergerfcy response plan*s:---lhese. reguJcit!ons and the planning basis for EP are based on thethree*elements discussed in'sectlon 2~'-1:
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NRC-appfov~d EP progr~~s* have lhe 't:c1pability to identify emergency conditions, assess radiological-.irrip~ct. commu1119ate protective action recommendations, and mitigate the event.
Offsite respon~e organizationsJOROs), maintained by local government authorities, are responsible for a~veloping their1 EF? programs applicable to offsite response. These programs give the capability.'tq al~_rt and potify the public, implement protective actions as warranted, and assess radiological cbf!diti9n,$'beyond the facility to protect public health and safety.
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The NRC and its predece~sor,the Atomic Energy Commission, issued 10 CFR 50.34, "Contents of Applications; Technical Information," and Appendix E to 10 CFR Part 50 in 1970 and since then, the regulations required applicants to describe EP in plans for coping with emergencies in Hcense applications. After the 1979 Three Mile Island nuclear power plant accident, the NRC recognized that siting and engineered safety features provide protection, but these must be bolstered by the ability to implement protective measures during the course of an accident.
Therefore, the NRC changed the scope and nature of the required emergency plans by issuing new regulations and supporting regulatory guidance in 1980. Licensees were required to submit upgraded emergency plans compliant with the new regulations and guidance.
EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 2-3 April 2017
This regulatory structure requires that site-specific emergency plans be developed and maintained in compliance with planning standards located in 10 CFR 50.47(b). Also, it requires licensees with offsite response organization (ORO) participation to conduct drills and exercises to demonstrate response capability, as well as critiques and corrective actions to address capability and performance weaknesses.Section IV, "Content of Emergency Plans," of Appendix E to 1 O CFR Part 50 describes the information a licensee's emergency plan shall contain, but is not necessarily limited to, in order to demonstrate compliance with EP requirements. In 10 CFR 50.54(q), the NRG gives requirements for following and maintaining the effectiveness of a licensee's emergency plan.
This EP regimen provides reasonable assurance that protective actions can and will be taken to provide adequate protection of public health and safety.
2.3 Guidance Documents NRG published, or the industry generated and NRG endorsed, many EP guidance documents.
The NRC Web site at http://www.nrc.gov/about-nrc/emerg-preparedness/regs-guidance-comm.html lists relevant guidance documents.,of both types.
EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 2-4 April 2017
- 3. REGULATORY ISSUES.
This section describes the regulatory issues stemming from the fact that SM Rs and ONTs could differ substantially from the existing fleet of large LWRs.
In 2010, in SECY-10-0034, the staff identified potential policy and licensing issues for SMRs based on the preliminary design information supplied in pre-application interactions and discussions with SMR designers and the U.S. Department of Energy (DOE). In general, these issues result from the key differences between the new designs and the current-generation large LWRs, such as size, moderator, coolant, fuel design, and operational parameters. Also, the issues result from industry-proposed review approaches arfd'industry-proposed modifications to current policies and practices. The sectiops' b~ldw discuss licensing issues identified in SECY-10-0034 that directly affect EP.
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3, 1 Size of the EPZ and Other Offsit,,EP~Require~er-ts
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The smaller size, lower power densities, lower/~ro.bability of sever~**"ac;c1dents, slower*accident progression, and smaller accident offsite con~~qu~nces per module th'at,ch~racterize SMR and non-LWR designs have led DOE, SMR designer~. ar:id potentiaJ operators*t9 'revisit the determination of the appropriate size of the EPZs,'tl:)~* extent of,onsite and off site.emergency planning, and the number of respons'e'"st~ff needed.' Oth~r topics raised by th~"industry involve the potential to revise alert and notifi~ati_q~*reguirementiqufc:t the appropriateness of the protective action requirements in 10 OFR 50._.if7(b)(10).
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3.2 Source Term*,* Dose Cal~i:iJ~tio~~*a~~d *S.iting<<
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The staff evaluates the radiologic~r*consequepce§ of the hypqt~etical DBAs for determining the appropriate siting anc:1-.theJ,evel ofsafety of the~plant design. Tne staff and design certification or license applicants use ac~id~nt s9Lrde terms in.. qos~ analyses to assess site suitability and the effectivene~s-of *the conta.ihment/and __ plaht rnitiga'tion,.features, and to show compliance with regulatign§ fo,r"det~rrnini.ng th~_amcii.mfotAose.t<? workers and members of the public.
Howeyer, the technical,basis for,l;:P c:;onsidets-~ wide spectrum of potential accidents for the facility:* inclyding severe*a~cidents':--:,_Therefore, tile staff does not limit the consideration to DBAs. Re~ctqr designers 'a(ld *license.applicants will need to establish appropriate credible source terms Jor.. ~MRs and Of'JT~ for this spectrum of accidents. Furthermore, the staff must consider the sb1.,m::~ terms asso_c;:iated wittfthe multi-module (multi-reactor) designs of some SMRs and ONTs;,yvhere those modules share structures, systems, and components (SSCs) to such an extent thaftl:)ei"E! is ~ p6tential for fuel damage and fission product releases to the
- environment from mo?-e. than,one module.
In SECY-93-092, the staff ~reposed that accident source terms for high-temperature, gas-cooled reactors (HTGRs) and sodium fast reactors should be based on a bounding mechanistic analysis that meets certain performance and modeling criteria supported by research and test data. The document provides a definition for "mechanistic source term" was given:
A mechanistic source term is the result of an analysis of fission product release based on the amount of cladding damage, fuel damage, and core damage resulting from the specific accident sequences being evaluated. It is developed using best-estimate phenomenological models of the transport of the fission products from the fuel through the reactor coolant system, through all holdup EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 3-1 April 2017
volumes and barriers, taking into account mitigation features, and finally, into the environs.
The conditions under which the use of design-specific and event-specific mechanistic source terms can be justified and used in licensing non-LWRs would have to be supported by experimental data to confirm the bounding parameters of the source term. In SRM-SECY-93-092, "Issues Pertaining to the Advanced Reactor (PRISM, MHTGR, and PIUS) and CANDU 3 Designs and Their Relationship to Current Regulatory Requirements," dated July 30, 1993 (ADAMS Accession No. ML003760774), the Commission approved the staffs recommendation. The technical basis for, and the uses of, design-specific and event-specific mechanistic source.terms in licensing are critical to the resolution of this issue. Also, the staff will ensure that uncertainties are appropriately taken into account The staff expects non-LWR designs of other types to follow this recommendation also:' In SECY-16-0012, "Accident Source Terms and Siting for Small Modular Reactors and Non-Light Water Reactors," dated January 15, 2016 (ADAMS Accession No. ML15309A319), the staff noted that SMR and non-LWR applicants can employ modern analysis tools to demonstrate quantitatively the safety features of those designs. Hence, applicants may use mechanistic source term analysis methods to demonstrate the ability of the enhanced safety features of plant desig.ils to mitigate accident releases.
In summary, for SM Rs and ONTs, the staff will consider ari appropriate spectrum of accidents and environmental consequences to prpvide a basis for.judging the adequacy of features such as functional containment design ancloffsite emergency planning. The staff intends to consider accident scenarios during power ascension, fuU-power operation, power decrease, shutdown, and low-power operations.
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3.3 Opera~or Staffing Some SMR and ONT designs may use multipl~ modules at one site with a single, centralized control room._ D.esigners have indicated that they.are considering designs that can operate with a staffing complement that is.less than what is currently required of large LWRs by 10 CFR 50.54(m). The staff wili consider emergen_cy response staffing commensurate with SMR and ONT designs and emerg~ncy response functions.
3.4
- . Co-Location of Facilities SMRs and ONTs of the same type may be co-located together on the same site or with large reactors, at industrial facilities, with different reactor types, or any combination of the above.
The policy issues associated with co-location include the need for guidance on the effect on EP of co-location, on the size of the EPZ, number of control rooms, staffing, training, and interaction with other co-located facilities.
3.5 Multi-module Facilities SECY-11-0152 discusses the potential for an SMR or ONT site to employ multiple reactors (modularity as defined in 1 O CFR 50.2). Probabilistic Risk Assessment (PRA) techniques can be used to obtain accident sequences, source terms, fission product releases, and dose assessments to define EP requirements that consider the maximum number of reactor modules licensed for the site and the sharing of SSCs.
EP for SM Rs and ONTs Rulemaking: Draft Regulatory Basis 3-2 April 2017
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3.6 Performance-Based Approach to Emergency Preparedness The.current approach for large LWRs to meet EP requirements is largely prescriptive planning standards.
In a performance-based approach to EP rulemaking, performance and results will be the primary basis for regulatory decision-making, and the licensee will have the flexibility to determine how to meet the established performance criteria for an effective EP program.
The preliminary critJria for defining the performance-based regulation include:
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Identifying suitable performance-based requirements*'th~t-will consider the 16 planning standards of 10 CFR 50.47(b) and the requiremen<s of10 CFR 50.54(q) and Appendix E
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to 10 CFR Part 50;
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Implementing procedures, facilities, organi{;tip~, trainin~:- activation processes, duty roster qualifications, shift staffing, resp,aflse organizations, cbr:nmµnication systems, facility location, and emergency requifements that are part of the licensee's responsibility to be demonstrated by setting up approp~i~te perfor'a~_ce indicator_s; *.
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- Defining an appropriate cor~ectiv,e action prcic~ss,for identified weaknes~~s and their correction consistent with the, significance of the wea,knesses;
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Demonstrating EP performance',in terms._of p(otecting public health and safety at a level comparable to or high~r than that-required for currently'eperating large LWR facilities; and
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Establishing 'an NRC ove?sight process that can ensure*that a high level of EP exists and that it provide~ for rea~onable assu'radce that public health and safety is protected.
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Some aspects -~I~ exp~cted to remain *unGhanged *qr r~vised appropriately from the current approach.. Examples9(these as,pects include~.'**--,.,_.*
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lnitj_al licensing revie~ ard issu~hc;:e of safety evaluations for lice"nsing submittals;
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Notifi~atl~n requireme~~s \\o Federal: State, and local authorities; i
I Drills and exercises deJl'lonstrating EP performance;
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Appropriate pub.lic.al~rt-a~d notification methods; Maintenance of a complete emergency response data system that can be used to appropriately investigate the emergency condition that occurred; and Changes to the emergency plan being subject to 10 CFR 50.54(q).
EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 3-3 April 2017
- 4. REGULATORY APPROACHES This section considers two options to enhance the effectiveness and efficiency of the regulatory framework for applicants and the NRC while providing assurance of public health and safety.
- Option 1 would use the existing regulatory framework supplemented by guidance on applying for exemptions to the rules.
- Option 2 would provide regulations through rulemaking to define the level of EP appropriate for an SMR or an ONT facility.
4.1 Option 1: Exemptions and Guidance
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This option would maintain the current EP regulations:in effect, Relief from regulatory requirements would continue to be granted on a case-by-case basis through the license exemption process. Guidance on applying fo~/suc~_-exemptions WblJ!d ~-e developed..
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Assessment of Option 1
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This option would retain the current.!;:F:' provision; in, 10 SFR P,~rt Sp. Beca'i:is~ *c~rtain existing EP requirements could impose unnecessa_ry regulatory_ burc;lens on SMR and ONT licensees, the potential applicants have indicat'eo thafthey would requ'est EP exemptions. This option would require site-specific analysis by ~h'e appJicar:it and re\\,'i.~W-py the NRC for each application. Option 1 would not relieve 't~e buraen imposed on. both the applicant and the NRC resulting from the case-;_by;;case. exemptiory p~ocess *9ddressing.'EPZ -size and emergency plans. In addition, wpile the-ex~fnption prdc~s~ c9uld be {urth~r enhanced through guidance development, this pfoc~~s woulc:I. no, likely reslilrin ~fficiency.,gains. By continuing to assess EP exemptions on an indhddu~I appliqitipn basis,\\~pP.Ucants and tne NRC would expend significant resources on preparing 'and -processing exemption requests.
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4.3-' _Option __ ~:---.Cond~ct Rulema~~ng ~ \\,_.*.
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This optipn would provide-.!=Pregulation~ and guiaance developed specifically for SMR and ONT facilities.
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Boundary Detem~!nation for Eril,ergency P1anning Zones l
The technical base;'f<;>r establi~hing EPZ requirements for SM Rs and ONTs are founded on the principles outlined in NlJ_REG:0396 and the current EPA PAG Manual [4]. The bases focus on establishing the radial dist~nce to the outer boundary of the plume exposure pathway EPZ for SMRs and ONTs, which is the critical element and affects other elements in the EP framework for these technologies. Other elements of a new EP framework are baselined with the regulatory EP framework in the Code of Federal Regulations for currently licensed large LWR facilities and then adapted or developed, as appropriate.
In November 2010, the staff reviewed the existing EP requirements associated with various nuclear facilities, including large and small reactors, material facilities, fuel facilities, independent spent fuel storage installations, and RTRs. This review found that all the existing types of NRG-licensed nuclear facilities use the dose-at-distance approach of NUREG-0396 to EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 4-1 April 2017
establish the boundary of their EPZs (or other planning areas) and consider the EPA PAGs to aid in decisions to implement protective actions.
Defining the EPZs for these new facilities is central to the approach to EP regulation whether it be prescriptive or performance-based. Considering that currently proposed designs for SMRs and ONTs are designed to have a reduced potential for accident-related offsite releases, the staff expects that consequences from an accident involving these technologies may have a limited impact on public health and safety, thereby forming a basis for smaller EPZs.
The establishment of the EPZ for the plume exposure pathway is necessary to define and scope the areas where planning for the initiation of predetermined p~ptective actions is warranted.
These prompt protective actions are directed at avoiding or.ri3ducing a projected dose to the members of the public. The ingestion exposure pathway,*EPZ provides an area of consideration for major exposure pathways associated with the ingestion of_ contaminated food and water.
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SECY-11-0152 discusses the staffs intent to deyelop*a technology-neutral (or technology-inclusive), dose-based, consequence-orientec:H~Pframework for SMR sites that takes into account the various designs, modularity, and(~o-l~>cation of these reactqrs, as well as the size of the EPZs. The staffs approach is based on the.concept that.EP requirein~nts could be scaled to be commensurate with the accident source term, fission product release*, and associated close characteristics of the SMR design. Issues relating tc{the*modularity of the designs and potential for co-locating the reactor~.nea*r industrial facilities*wm also need to be\\iddressed.
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In response to SECY-11-0152, the Nuclear Energy.lnstitute'(NEI) prepared "White Paper:
Proposed Methodology a!Jd_ Criteria Est~~lil?hing th~ 'reGhnical -Basis for Small Modular Reactor Emergency Planning ~one,"_ is*su~d Decerh.ber 201 ;n3], __ whiGh proR_9sed a generic methodology and criteria that could.,be acopted and used.for establishing the technical basis for SMR-appropriate EPZs. ltpdd.ressed *sMRs with light~Wpt~r-coolea -and moderated designs only and did not specifically address other types of SM Rs or. other facility designs. It also focused on the plume exp~~-~~_pat~way*-~~Z: }he NRChas n6\\.. ~n.~orsed this White Paper.
As stateci\\n SECY:at1-b 1 !?2,,.the. st~; e~-pect~ *ttiat the industry will develop and implement detaile'd calculation methods for'rev1ew and approv'al by the NRC. In this case, the applicant will have th'e ~urden of offering a well-jus.tified basis for the proposed EPZs sizes consistent with the potential off~ite _consequence, profile oHhe facility.
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In SECY-11-0152~ th~ staff pre~en,ted ex~mples of different plume exposure pathway EPZ boundaries that are,~stablisheq based on the 1-rem (10-mSv) EPA PAG reference value. It used an example asse.ssmenJ'of dose-at-distance for the plume exposure pathway EPZ boundary to obtain a rahge* of E;PZs based on the projected source term, which is a function of specific reactor design being.considered. The examples in SECY-11-0152 consider four discrete zone boundaries or categories: site boundary, 2 miles (3 km), 5 miles (8 km), and 10 miles (16 km): *
( 1) If projected accident offsite doses are less than 1 rem ( 10 mSv) total effective dose equivalent (TEDE) at the site boundary, then no plume exposure pathway EPZ beyond the site boundary would be required, and the offsite radiological emergency planning requirements would be limited.
EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 4-2 April 2017
(2)
If the expected offsite dose is greater than 1 rem (10 mSv) TEDE offsite but less than 1 rem (10 mSv) TEDE at 2 miles (3 km), then the requirements for the plume exposure pathway EPZ would be limited to the 2-mile (3-km) zone.
(3)
If the projected offsite dose is greater than 1 rem (1 O mSv) TEDE at 2 miles (3 km), but less than 1 rem (10 mSv) TEDE at 5 miles (8 km), the size of the plume exposure pathway EPZ would be 5 miles (8 km).
(4)
If the expected offsite dose is greater than 1 rem (1 O mSv) TEDE at 5 miles (8 km), the size of the EPZ would default to the current 10-mile (16-km) plume exposure pathway EPZ.
Ingestion Exposure Pathway Emergency Planning Zone /..
The purpose of the ingestion exposure pathway EPZ is*fo prevent the ingestion of contaminated foods and water.
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The ingestion exposure pathway EPZ for large LWRs is established,;1t about 50 miles (80 km),
as reflected in regulations in 1 O CFR Part 50.( Th13 duration of any exposur~ could range from hours to months and represents a longer-temi'*res*ponse need._ Addition.ally, the source terms for SM Rs and for many ONTs are small and may>following,the above desc:'ribed process, have a small plume exposure pathway El?Z or none required;- if'the-offsite projected dose would not I
exceed the EPA PAGs at the site explusion area boundary. Because the source terms are small for these technologies and related-ingestion represents a longer-term response, a scaled approach where the size ranges from the site boundary to a fixed-distance beyond the site boundary may be approprLate for the ing~stion expqsure pathW~y EPZ. That is, if the plume exposure pathway EPZ is the site and bour:,ded by tfie site boundary; no ingestion exposure pathway EPZ may qe"necessary. R.einfordng thi_s*premlse, _the United States has had considerable experier:ice with thEh;~xpedient largEM~cale quarantining of foods in response to contamination outbreaks of E. coli; salmonella,**bovine spongiform encephalopathy (mad cow disease), and Qthers. The.succ~s'sfu*1 quarantine,an9 removal from public access of contaminfitd food and water products in response\\to biological contamination suggest that for SMRs.i:ind ONTs, the_ response.to prevenringestion* of contaminated foods and water, were it deemed necessary, could be performed in a similar manner.
- Technology-Inclusive Approach The EP measur~s established f,or the current NRG-licensees have proven effective regardless of the technology'. A similar technology-inclusive approach can be applied to SMR and ONT facilities while taking-into accqu.nt the various designs, systems, and purposes of the facilities.
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Small Modular Reactors The staff considered the use of multiple reactors and the potential for SMRs to be co-located near or adjacent to industrial sites during the development of this document. Co-location offers the potential for SM Rs of the same type to be located together or with large reactors, at industrial facilities, with different SMR types, or any combination of the above. Also, the staff considered the need for preparedness from hazards from events which may occur at co-located facilities.
Some SMR designs are employing inherent passive safety characteristics, below-grade or in-ground construction, natural circulation decay heat removal, interconnected EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 4-3 April 2017
systems, and advanced fuel types. Burying part or all of the reactor and structures will affect the height of a release, which would be at or near ground level. A ground-level release would affect the dispersion of the plume. Buried reactor structures and pools may have longer drainage times and correspondingly longer accident progression times.
Passive safety features that do not depend on electric power also lead to longer accident progression time. These design aspects will determine the accident frequency, progression, and potential consequences.
Other New Technologies The NRG has not issued a license for a commercial non::.L.,WR facility for construction or operation since Fort St. Vrain in 1973. As discusse~J>revibusly, the NRG has licensed LWRs with relatively low power (Big Rock Point CJntl L~_-Crosse) and an HTGR (Fort St.
Vrain), each with a plume exposure pathway EPZ s.ize thc;1t was smaller than those for large LWRs. The plume exposure pathwax ~_P?~ for Fort St. Vrain, Big Rock Point, and La Crosse were each established at 5 miles (&-km). Additionally, in February 2016, the NRG approved a construction permit f9(a ry_ew and innovativ~ rhe!dical isotope production facility submitted by SHINE;: ltJe safety evaluation r~port [5] related to the construction permit for the SHINE facilit}( states, "The ~ize of the EPZ-should be established so that the dose to individual~qeyqnd the' EPZ is not proj~cted to exceed the [EPA] PAGs," NUREG-2189,_"Safety Eval~atiori '3eport Related tc>"~81NE Medical Technologies, Inc. Construdti_on,ferr:rit Applicaliqn fQr a Medical Radioisotope Production Facility."
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The staff has discuss~d,the"'15en~fits of EP }u)e1J1pking fot-S,MRs.and ONTs in SECY-15-0077.
A performance-basJd approach to EP regulatipn, ~s/discussed -in this regulaJory basis, is being considered at this time as'tl:)e app~opriate meah~. to achieve objectives, such as:
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ProiTloteregulatory \\tabilitwpredidability, 'an~.clarity: In the performance-based
,approach~*the.applicarits will demonst(ale how"their proposed facilities will achieve EPA
( PAG dose limits*-afspecified EPZ distances-'for their site, which may include the site bounqary. This tr'amework is.[ntended to be established generically without site-or de~ign*:.specific informatiqn abdui source terms, fission products, or projected offsite dose:*,'<th~r EP plannhm standards.and requirements will be commensurate with those determination~. This approach will give clear guidance to the applicants such that the applicants 'cari'*structure,ltheir applications to support predictable regulatory decisions.
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Recognize tech'iiolo'tjical advancements embedded in design features: SMRs and ONTs are expected to encompass many advances in technology in their varied designs. In the generic performance-based framework intended for the rule, such advances are inherently recognized. Facilities with reduced potential offsite consequences will have reduced EP requirements and vice versa. A performance-based approach is an effective way to make regulatory requirements consistent with design features and associated potential accident consequences.
Credit small reactor core size and associated differences in accidents: SMRs and many ONTs involve smaller sized reactor cores, and the accident profiles are significantly different from large LWRs. These designs are associated with a low likelihood of severe accidents, slower transient response times, and relatively small and slow release of EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 4-4 April 2017
fission products. Current EP rules and requirements were developed for large LWRs. A new performance-based EP rule for SM Rs and ONTs will assess and take into account the small size reactor core and source terms for these designs. Different aspects of the EP regulations and requirements will be defined consistent with the characteristics of the accident scenarios.
Eliminate the current regulatory need to request exemptions from EP requirements:
Licensing SMRs and ONTs within the current regulations, developed for large LWRs, requires approval of exemption requests. This approach is known to lead to inconsistencies and undue burden for both the applicant and the regulatory authority. A performance-based approach to EP regulation that is generically established without site-or design-specific information about source ter,rrts, fission products, or projected offsite dose has the potential to eliminate any ne~d to consider exemptions for SMRs and ONTs.
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4.3 Conclusions
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Option 1 would not relieve the burden impos&! or(both the applicant*~*n9 th~ NRG resulting from the case-by-case exemption process. In ~ddition, while,.,tti_e exemptiop pr9cess could be further enhanced, this process would not likely reSu]t in th~.-efficiency gains 'possi_ble through
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- Option 2. By continuing to assess !=P ex~mptions oh-.an indjvidual application b.asis, applicants and the NRG would expend resources o.n'*preparing ancLproc::essing exemption requests.
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Option2 would provide a clear set of r~l~s ~na-g~idance fo~'E.~ fqr SMRs and ONTs and reduce the need for EP ~xempJions as applicants**reguest permit~ and licenses. It provides for regulatory stability an9-*t>re:cHc;t_~bili!_Y.
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Considering the abo~e o~tions, -~he ~taff con21ud~s that 1) ~he*p~i.nciple of using a dose-at-distance approach to det~m:iine a~ E'Pz size c~ri be applied to SM Rs and ONTs, and 2) the rulemaking for.. SM~s and *QNT~)s th'e.. mo~~ effe6ttve and desirable path for both the NRG and applicants,for SMRs*and ONTs.
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The staff notes that EP'r~~iul~tions,currently, ~'d-.\\ft)ill in the future, rely on accident analyses to determine. potential radiological consequences, given as dose-at-distance. Specific information regarding source term, -isotopjc'rnix, releas~ pathways, accident types and consequence assessment for_$MRs and ONTs'yvill be provided as required, and as part of the application process under 1'0. CFR Parts 50 and 52.
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EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 4-5 April 2017
- 5. OTHER REGULATORY CONSIDERATIONS 5.1 Cost and Impact Considerations 5.1.1 Introduction The potential benefits and costs justification must be considered for (1) SMR and ONT licensees, (2) offsite government organizations (i.e., State, local, and Tribal), and (3) the NRC.
The analyses in this section are based on the staff's assessment and input from stakeholders.
Impacts to the general public are not included at this stage of t~e process. A more detailed evaluation of benefits and costs would be carried out during,the regulatory analysis that would be part of the next step toward rulemaking (see Section 1: 1 ).
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The staff considered the exemption and guidance altefnativeto a rulemaking action, is discussed in Section 4.1 of this document. The N.RC is-pursuing rulemaking action because it offers a comprehensive regulatory framework that would result in enhanced regulatory stability, predictability, clarity in the licensing process,,opportunity for stakeholder input on the regulatory framework. This is also in keeping with the implementation of the Commission's direction in SRM-SECY-15-0077 and SRM-SECY-16-0069.
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The analyses in this chapter presen~ the il)cremental b~nefits and costs that would be incurred by the licensees, NRC, and offsite governmental organizations from the rulemaking action.
Incremental benefits and costs are calculated.values and impacts that are above the baseline condition. The baseline condition for this rulemaking action includes the benefits and costs to comply with current EP_regulations in 10 *cFR 50.34110-CFR 50:47(b); 10 CFR 50.54; 1 O CFR 50.90, "Application-for Amendment.of License, Gonstn,1ction Permit, or Early Site Permit"; and Appendix E to 10 CF:R Part 50. *. Based on the st~ff's assessment, the incremental benefits and costs for this rulemaking action may include the following:
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incremental avert~d costs to eliminate the' current regulatory need for certain applicants to* request exemptions from current. l=P regulations incremental averted costs fo adopt an appropriate scalable EPZ size that differs from current EPZ sizes.
incremental costs to the NRC for ru.lemaking I
The staff recognizes that the benefits and costs described in this draft analysis are order of magnitude estimates suqjecrto further refinement and input from stakeholders. However, these estimates are useful to eliminate unviable solutions, to establish feasibility, and to identify potential trade-offs early in the process. The staff expects that the proposed rule and related guidance development associated wi_th the proposed rule would clarify the scope and would allow for further refinement of these analyses. The staff will offer additional opportunities for comments on the preliminary rule language and proposed rule language as these products are developed.
EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 5-1 April 2017
5.1.2 Potential Effect on Licensees This rulemaking will create a set of EP regulations specifically for reactor designs that fall within the definition of SM Rs and ONTs. Therefore, those licensees will not have to incur the incremental costs normally associated with the exemption process that would have been otherwise required for the current EP regulations. This includes the costs of preparing the exemption requests and responding to the NRC's requests for additional information via multifaceted interactions, such as correspondence, teleconferences, and meetings. Table 5-1 shows these averted costs, using the assumption that four applicable nuclear power plants will be built in the near future, and that 1,483 hours0.00559 days <br />0.134 hours <br />7.986111e-4 weeks <br />1.837815e-4 months <br /> of labor are needed for every plant, and that the weighted hourly labor rate is $117 per hour.
/
Table 5-1 Industry Operation: Emergency Planning Exemption Requests
- ,, Total Averted Cost Year Activity 7%NPV 3%NPV
//
Undiscounted 2019 Two exemption requests for SM Rs/ON.Ts*.
$348,0oo** $304,000
$328,000 2020 Two exemption requests for SMRs/ONTs.
$348,000 $2~4;000
$318,000 Total;
/$696,000 $588,000
$646,000 Note: NPV = net present value.
(
Under current regulations for large ~vvR:aesigns,. the pl~me *exposure pathway EPZ size is about 1 O miles. However, for SMRs and ONTs with ~omparatJvely smaller reactor cores and power levels (smaller so4rce terms) as well as with.passive design f~atures, and with the proposed adoption of a scal.abie plume exppsure pathwc!y EPZ size approach, the potential exists for the plume,exposure pa.thway EPZ to b.e at.the site. ~oundary. The staff believes that this aspect of the rule :would represent significant incremental averted costs to licensees. For example, licensees would only ne~d to establish an onsite emergency plan with demonstrable indicators for the N.RC to.fo:id re/as'onable a~suran~e that adequate protective measures can and will be taken in the event of a radiologicaL.~mergency\\ Averted costs in this scenario would result from.the removal of the requirements* fo~ (1) evacuation time estimates *and corresponding annual ~nd decennial updates, (2) pubJic alert and notification system (PANS) installation and annual maintenance, (3) Federal Emergency Management Agency (FEMA) annual user fees, (4) annual drills and exercises, and (5) State agreement and licensing annual fees.
\\
'\\..
\\
For the purposes of this regulatory basis, the staff assumed that the four plants used in this analysis will each have a plum~ exposure pathway EPZ inside the licensee's site boundary.
Table 5-2 and Table 5.,;3 sho~,/the total averted costs to these plants as a result of this proposed rulemaking. The (averted) total costs shown in Table 5-2 and Table 5-3 are the totals for the four future plants discussed in this analysis that the staff has assumed will be affected by this rulemaking.
EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 5-2 April 2017
Table 5-2 Industry Implementation: Averted Costs with the Plume Exposure Pathway EPZ Inside the Site Boundary Year Activity Total Averted Cost Undiscounted 7%NPV 3%NPV 2019 Evacuation time estimate averted costs
$750,000
$655,000
$707,000 2020 Evacuation time estimate averted costs
$750,000
$612,000
$686,000 2019 Initial plan development with ORO
$9,384
$8,197
$8,846 2020 Initial plan development with ORO
$9,384
$7,660
$8,588 2019 Siren stations (ANS) setup averted costs
$7,670,000
$6,700,000
$7,230,000 2020 Siren stations (ANS) setup averted costs
$7,670,000
$6,260,000
$7,020,000 Total:
$16;900,000 $14,200,000 $15,700,000 Note: NPV = net present value.
(
Table 5-3 Industry Operation: Recurring Averted Cosfs with the Plume Exposure Pathway EPZ Inside the Site Boundary*
Year Activity for All Four Plants Un.discounted Evacuation time esUmate 2020-2077 (ETE) annual update$,
$1';6_50,900 2020-2077 FEMA annual user fee
$146,700,'oo,o averted costs ANS annual maintenance 2020-2077 fee
\\
$?78,700,000
/
~~.
Drills/exercises averted
/
2020-2077
$24,650,000 costs*.
2020-2077.. State agre.ement/licensing fees_
\\~802,700,000 202072077.. Lette.rs of Agreement
- . **$1,080,000 2020-2077 Offsite Coordinator
$27,470,000 2030 ETE decermial update *
$350,000 2040 ETE decennial update..
$350,000 2050 ETE decennial update
$350,000 2060 ETE decennial ~pdate
$350,000 2070 ETE. decennial ;update
$350,000 2030 PAR DevelC>pment post
$290,000 decennial.update 2040 PAR Development post
$290,000 decennial update 2050 PAR Development post
$290,000 decennial update 2060 PAR Development post
$290,000 decennial update 2070 PAR Development post
$290,000 decennial update Total:
$1,286,000,000 Note: NPV = net present value.
EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 5-3 Total.Cost 7%NPV 3%NPV
$350,006*
$740,000
$31,430,000
$65,850,000
',,_$59,710,000
$125,100,000
$5,280,000
$11,070,000
$172,000,000
$360,400,000
$230,000
$480,000
$5,890,000
$12,330,000
$140,000
$240,000
$73,000
$180,000
$37,000
$130,000
$19,000
$97,000
$10,000
$72,000
$120,000
$200,000
$62,000
$150,000
$31,000
$110,000
$16,000
$82,000
$8,000
$61,000
$275,400,000
$577,300,000 April 2017
When the plume exposure pathway EPZ is determined to be outside of the licensee's site boundary and less than about 10 miles, the licensee would be required to include offsite response coordination in its emergency plans, in accordance with 10 CFR 50.54(q), 10 CFR 50.47(b), and Appendix E to 10 CFR Part 50. However, the staff believes that this aspect of the rule would result in an incremental averted cost to licensees. This is because the cost for establishing, for example, a 2-mile plume exposure pathway EPZ offsite emergency plan would most likely be different from the costs of establishing the current 10-mile plume exposure pathway EPZ offsite emergency plan. This averted cost would depend on factors such as the complexity of emergency planning due to the geographical areas associated with governmental organizations and OROs.
Table 5-4 shows the revised estimate of averted costs toAfidustry for scenarios where the plume exposure pathway EPZ is outside the site boundary but'with a*radius of less than 10 miles. In these scenarios, to be conservative, the costs listed.i_n. Table s--~ are no longer considered averted costs. Additionally, the evacuation time ~stiniates and iriiti_al plan development costs are no longer considered as averted costs. Thef remaining averted c9st in this regulatory basis is from the less extensive ANS required due t<;> the smaller plume expo~ure pathway EPZ relative to the 1 O mile radius plume exposure pathway EPZ currently in regulations. Table 5-4 scales the averted industry implementation costs'frpin TabJe 5-2, based on*tt~e area of the plume exposure pathway EPZ in square miles, relative to the area of a plume***e?{posure pathway EPZ with a 1 O mile radius. Finally, *this analysis assume_s that licensees would still submit exemption requests, as the rulemakihg W04ld not be able*to* consider all possible plume exposure pathway EPZ size scenarios*... Tl:lerefofe,-.these exe~pt!on requests are also not considered as an averted _c:;pst if the plurh.e exposur.e pathway EPZ is outside the site boundary.
/,,"'
Table 5-4 lndust;,, lmple~entation: 'S~aUn'g Averted *costs for a Plume Exposure
. P h '*
EPZ O. *d h s*
B at wav uts1 et e 1te oundarv
\\
Total Cost Radius (miles)
I
\\
/
,. Undiscour'ited
\\ **.7%NPV 3%NPV 1
$12,420,000*
$10,490,000
$11,710,000 2
'*, $9,810,000.
$8,290,000
$9,250,000 3
'$,7,510,000
$6,350,000
$7,080,000 4
$5;520,000
$4,660,000
$5,200,000
- -5 ',
\\
. $3,830,000
$3,240,000
$3,610,000 6 *.
$2,450,000
$2,070,000
$2,310,000 7
I
- $1,380,000
$1,170,000
$1,300,000 8
$610,000
$520,000
$580,000 9
$150,000
$130,000
$140,000 10
$0
$0
$0 Note: NPV== net present value.
As can be seen by comparing Table 5-4 to the NRC rulemaking costs given in Table 5-5 below, if the plume exposure pathway EPZ has a radius of 4 miles or less from the site boundary, this regulatory basis shows that the costs of the rulemaking are estimated to be less than the averted costs shown above, indicating this rulemaking will be quantitatively cost effective.
Lastly, additional benefits for SMR and ONT licensees will be realized because this rulemaking will give greater regulatory stability, predictability, and clarity to the licensing process. This is EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 5-4 April 2017
mostly because the licensee would no longer need to use the exemption process to establish EP criteria commensurate with the reactor design.
5.1.3 Potential Effect on Offsite Governmental Organizations Because SMRs and ONTs are being designed with smaller source terms, and with the adoption of the scalable plume exposure pathway EPZ size, the potential exists for the plume exposure pathway EPZ to be at the licensee's site boundary. However, when the plume exposure pathway EPZ is determined to be outside of the licensee's site boundary and less than about.
10 miles, offsite governmental organizations may need to establish a formal radiological emergency preparedness (REP) program. The staff believes.that this potential requirement would represent an incrementaf averted cost to offsite gov~rri'merital organizations in the plume exposure pathway EPZ because the cost for establishing(for example, a REP program for a 2-mile plume exposure pathway EPZ would most likely.,be different from the cost to establish a REP program for the current 10-mile plume exposyr~'p~thway-~PZ_. This averted cost would depend on factors such as the complexity of the REP:program due to.the geographical areas associated with offsite governmental organizaJi6ns;. These averted c9~ts are reimbursed to the offsite governmental organizations through F~MA fees and State agreements, shown in Table 5-3 above.
- '\\,,,,
//
5.1.4 Potential Effect on the NRC
\\
~ ~
The NRG's development and implem*eritation *of EP regufations for SM Rs and ONTs through a rulemaking would result in incremental' G<>~t~ to ~he NRG. Th~se.costs include the preparation of the regulatory basis docurn_ent, rule lah,guage, an~facGompanying draft guidance documents.
The costs would includeboth staff and contractor ti,111e t9 prepare* prdposed rule language, draft guidance, supporting*'analyses**(e.g., a draft'regulafory 'analysis,.draft environmental analysis, and draft Office of Ma_nagement al,'ld,.Budget P;3perwork RedLlction Act supporting statement), a Federal Register notice;.,ahd public o'utreach du~in:g the proposed rule and draft guidance development phase. After,publisKing the.propos~d *rule, the NRG would incur costs associated with publl,d5omment r~solutiqn ano-prep~_ration of't~e final rule, final guidance, and supporting documentatiohs-for*th~ 'rul_emaki,ng. The NRG, iias _committed a significant number of technical staff t6.. de~elop the rulem.aking a'nq related guidance over a 4-year period. These estimated costs are,shown in Table *s::._5,' where.c;:osts are for the single action in each row at a labor rate of
$128 per ho1,1r;..
\\
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EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 5-5 April 2017
Table 5-5 NRC Implementation: Rulemaking Costs Year Activity 2016-Develop regulatory basis 2017 2017 Develop regulatory guide (RG) for proposed rule 2017 Develop proposed rule 2017 Revise RG after public comments 2018 Develop/issue RG for final rule 2018 Develop/issue final rule 2019 Develop/issue RG for final rule 2019 Develop/issue final rule Note: NPV = net present value.
Hours 4,025 1,610 4,025 1,610 1,610 4,025 1,610 4,025 Total:,
/
/
Total Cost Undiscounted 7%NPV
($515,000)
($515,000)
($206,000)
($206,000)
($515,000)
($515,000)
($206,000)
($206,000)
($2Qs;ooo)
($193,000)
($5'15,000)
($481,000)
/ ($206,000)
($180,000)
- ' ($51'5,dOO)
($450,000)
'($2,885,00_0) * ($2,747,000)
(
3%NPV
($515,000)
($206,000)
($515,000)
($206,000)
($200,000)
($500,000)
($194,000)
($486,000)
($2,823,000)
The benefits to the NRC include meeting the gc;>als of the NRC's 2014-2018 Strategic Plan (NUREG-1614, Volume 6, "Strategic Plan: Fiscal-Years 2014'=-2.018," issueq August 2014) in relation to the strategic goal of safety, and the cross:-ci.Jttin{strategies of reguJptory efficiency and openness, as discussed in Secfiori 5.5 of this docu_rrienJ; *Additionally, the 'NRC will receive
- an averted cost (benefit) from the exRect~d four exemptio.n requests that will not be submitted by industry and, therefore, will not be '-r~viewed by the staff;.. Table 5-6 shows these averted costs, assuming 713 hours0.00825 days <br />0.198 hours <br />0.00118 weeks <br />2.712965e-4 months <br /> of effort for each requ~st a[ld a labor'rate of $128 per hour.
\\
Table ~-Ef, ~RC Operation:., Averted Exemption Re~uest Reviews
\\
Totai Averted Cost Year Activi~'y
\\
Undiscounted 7%NPV 3%NPV 2020 1-Review two exemptipn.r.eque_sts
\\
$183,000 $149,000 $167,000
,2021 I Review two exe,mption requests.
$183,000 $139,000 $162,000 Total,,
$365,000 $288,000 $329,000 Note: NPV = net present value.
5.1.5 Cost Justification\\.,
Relative to the no-action baselir;,es of the EP regulations for SMRs and ONTs, the staff concludes that the benefits of improved regulatory efficiency and certainty to the licensees and the NRC, and the averted* incremental costs to the licensees and offsite governmental organizations, especially the flexibility for licensees to adopt an appropriate scalable plume exposure pathway EPZ, justify the incremental costs for this rulemaking action by the NRC.
Furthermore, the rulemaking would also benefit the NRC because no future resources would be expended for evaluating routine exemptions requests to current EP regulations by SMR and ONT applicants. Table 5-7 shows a significant net benefit (averted cost) for the quantitative factors discussed above. This cost estimate reflects the assumption that the plume exposure pathway EPZ will be inside the site boundary, which the staff considers to be a likelihood based on discussions with industry. The qualitative factors are also primarily averted costs and benefits and are expected to be of a lesser order of magnitude than the costs quantified in this regulatory basis.
EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 5-6 April 2017
Table 5-7 Total Costs with the Plume Exposure Pathway EPZ Inside the Site Boundary Attribute Total Averted Costs Undiscounted 7% NPV 3% NPV Industry implementation
$16,850,000
$14,240,000
$15,650,000 Industry operation
$1,286,740,000
$276,000,000
$577,900,000 Total industry cost
- $1,303,600,000
$290,200,000
$593,600,000 NRC implementation
($2,890,000)
($2,7.50,000)
($2,820,000)
NRC operation
$370,000
/$.
/
290,000
$330,000 Total NRG cost
($2,520,000)
($2,460,000)
($2,490,000)
Net -
$1,301,070,000
$287,800,000
$591, 100,000
(
/"
Note: NPV = net present value.
//
If the plume exposure pathway EPZ is outside Jne s_ite boundary, but less than 10 miles in radius, then the total cost estimate for the rulefina_king is variable depending on the plume exposure pathway plume exposure pathway EP~ r~dius. A cost estimate. for. a 4 mile plume exposure pathway EPZ is shown below in Tab1e**5'."a*, demonsfrating that a'plLime exposure pathway EPZ of 4 miles in radius or le~s will result,in,_ave,r:te'd 9dsts exceedir1g.the.costs of NRC rulemaking. Based on information 6-rovided by industry, th~ NRC does not expect that future SMRs and ONTs would have a plurri~ exp9sur.e pathway,~P4 greater than 4 miles outside the site boundary. Therefore, the rulemal<ifl9* wou.ld be_ cost justi_fied, because the averted costs would exceed the costs of the rulemaking p_roc~ss,.. **-..
A**'"'--~.*
\\\\
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- ~
,/
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1' Table 5-8 Total C_,.osts_with...the_Plume E~posµre Path_way_Epz*4 Miles Outside the Site
-~
Bbundary
\\
\\
\\
T
\\.
\\
\\
I T9tal Averted Costs (Costs)
Attribute '--,.
Undjsco1,1ntect.
7% NPV 3% NPV
/
Industry *implementation~.
$5,520,000..
\\
$4,660,000
$5,200,000
- ~.-*
- fndustry operation...
$0
$0
$0 Total industry cost
$5,520,000
$4,660,000
$5,200,000 NRC implementation *\\
'*., $0
$0
$0 NRC op~ration
\\
($2,890,000)
($2,750,000)
($2,820,000)
\\
Total NRG cost
($2,890,000)
($2,750,000)
($2,820,000)
Net
$2,630,000
$1,920,000
$2,380,000
- Industry implemeritation averted-costs depend on the size of the plume exposure pathway EPZ outside the site bounda[Y."_,
Note: NPV = net prese~t,'(~h.ie.
5.2 Backfitting and Issue Finality Backfitting and issue finality regulations do not apply to this action. The proposed revisions to performance-based EP requirements would not constitute backfitting because they would contain new requirements to ensure adequate emergency response for new facilities. There are EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 5-7 April 2017
no current SMR or ONT license holders who would be affected by the proposed rule.1 The intended rule defining the new performance-based EP regulations and guidance for SMRs and ONTs would be in place before any licenses are granted for new SMRs or ONTs. The backfitting and issue finality regulations do not protect current or future applicants. Therefore, the NRC will not prepare a backfit analysis for the proposed rule.
5.3 Cumulative Effects of Regulation The NRC has implemented a program to address the possible.cumulative effects of regulation (CER) in the development of regulatory bases for rulemakir19s'. The CER is an organizational effectiveness challenge that results from a licensee or otl;ler affected entity implementing several complex positions, programs, or requirements.within _a' prescribed implementation period and with limited available resources, including the abiiity to ac'ces*sJechnical expertise to address a specific issue. The NRC is specifically:..requesting corhm.ent on the cumulative effects that may result from the proposed amendmen! t6 10 CFR Part 50 an~ ai:,y other NRC actions that may affect the same entities. These requests are part of the questions for public comment in Section 6.2.
,/""*.
',.. '-.~.'
//. : / '
5.4
- Environmental Analysis
.. /
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- ,,,,, /
This rulemaking would develop perfo'rrna:nc~-based EP requir~ments for these technologies that would be commensurate with the potential con~teqll~nces to,RLib!!c health and safety and would not be a majqr Federal a~!19!1. significantly affecting tfie quality*ot th~ human environment;.
therefore, an environm.er'ltal impact statem~nt woul<f7not oe.required; An environmental assessment developed alonirwi~h the ruleniaking-vvoulcflikely conciude thatthere would not be a significant impact to, th~ public fr.pm this actiC>n'b~cause safety* and dose criteria would be chosen to ensure thaf'public healtlil and safety will be protected. The environmental impacts associated with licensing-SMRs of ONTs will be'considered in the process for individual license
...,/
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applications.
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~
51~ ( NRC Strategic Pl~n :*
- ~......., -- :
The planned, rulemaking supports the NR,G'.~ 2014-2018 Strategic Plan (NUREG-1614) in relation to the ~trategic goal of_,safety and the cross-cutting strategies of regulatory efficiency and openness. *,. *
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For the safety goal, th~ planned rulemaking would support NRC Safety Strategy 2, "Enhance the risk-informed and perforiJlance-based regulatory framework in response to advances in science and technology, policy decisions, and other factors," because it would develop performance-based EP requirements for these technologies that would be commensurate with the potential consequences to public health and safety. In addition, the planned rulemaking would support NRC Safety Strategy 3, "Ensure the effectiveness and efficiency of licensing and certification activities to maintain both quality and timeliness of licensing and certification reviews," by developing a performance-based regulatory framework that would significantly support an NRC licensing initiative with a future regulatory benefit, considering Commission and congressional interest in SMRs and other new technologies.
One medical isotope facility (SHINE) currently holds a construction permit; however, the review only included a preliminary emergency plan. This facility may apply for an operating license in the future, at which time EP will be considered.
EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 5-8 April 2017
Of the cross-cutting strategies, the planned rulemaking would support Regulatory Effectiveness Strategy 2, "Regulate in a manner that effectively and efficiently manages known risks and threats, clearly communicates requirements, and ensures that regulations are consistently applied, are practical, and accommodate technology changes in a timely manner," because the rulemaking would allow the reduction of plume exposure pathway EPZ sizes that could be smaller than what is currently required by 10 CFR 50.47(c}(2} but still reflect offsite consequences and radiation risks to public health and safety. In addition, soliciting input from
- the public on this regulatory basis during the development of the rulemaking supports Openness Strategy 1, "Transparency: Make clear information about the NRC's responsibilities and activities accessible to stakeholders."
5.6 Regulatory Flexibility Act
//
/,//
/
The Regulatory Flexibility Act, enacted in September 1980, f~quires agencies to consider the effect of their regulatory proposals on small entities., ahalyze alternatives that minimize effects on small entities, and make their analyses avail~t:>le f9r public coinrnent.
/
None of the applicable licensees fall within th{defi~mon of ;,small entities" set forth in the size standards established by the NRc* in 10 CFR 2~afo, "NRC Size Standards.."* Therefore, a proposed rulemaking would not have a significant"ecbnomic~ffect on a substa'ntial number of
/
small entities.
- , * /
(
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.~....
Peer Review of Regul~t~ry-*Basis--
5.7
.\\\\,- '
The Office of Management ana Budget's "~inal lnfo,rmation Quality Bulletin for Peer Review,"
dated December 16,.,200.4, requires each Fepe~al* ag~ncy tq, subject "influential scientific information" to peer 1r~vie~ before, dissemination. }"he Office defines "influential scientific information" as "scientific informati,en: the agency reasonably can determine will have or does have a clear a_n_q_ substariti?f il"flpJ1Ct on important-public policies or private sector decisions."
This regulatory basis document *does not contain influential scientific information." Therefore, there ir-n'o neecffor-a._peer re~ie~ of the r~gu[~tory hasis..
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EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 5-9 April 2017
- 6. STAKEHOLDER INTERACTIONS 6.1 Past Interactions Many public meetings and other interactions have taken place between the NRC and stakeholders on licensing-issues related to SM Rs and ONTs. The well-attended recent DOE-NRC Workshops on Advanced Non-Light Water Reactors in September 2015 [6] and June 2016 [7] addressed many of these issues. An April 2016 report from the Nuclear Innovation Alliance, "Enabling Nuclear Innovation: Strategies for Advanced Reactor Licensing" [8], also addressed many of these issues.
/
As the discussion of rulemaking for EP has evolved (see Section 1.2.3), some of the interactions with stakeholders have specifically dealt witn'EP. Of notable interest is the December 2013 NEI white paper [3] which focused orfthe-pllHrie exposure EPZ for light-water SMRs. The stated objective of the paper was as follolfifs:*
to propose a generic methodology and 'criteria that can be adopted and used for I
establishing the technical basis for SMR-appropriate EPZs. To that end, [the]
paper is intended to serve as a vehicle to.support th~. continuing dial6g1,1e with the staff that should result in 9 mutually ag}e~able.m.ethodology and *criteria, and thus provide the SMR develppers and applicants sufficient guidance as they proceed to develop their design-specific and site;.specific technical basis.
The approach in the NEI white paper~-_ '
~~
\\
is rooted in: (1 )the expectation of enhanced safety inh~rerit iil the design of SM Rs (e.g., ihcreased sa(ety margin, red1:i"c~d risk;*sm_aHer and slower fission product accident release, and reduced**potential for dose consequences to population in the-yicinity of1the plant); (2) the applicable SECY-11-0152 concepts inch,1ding utilization*qf existing ~imergency'-1;1reparedness regulatory framework anfl dose s;:ivings criteria of NUREG-0396; 'and (3) the significant body of risk
, information availabl~ to**inform the technical l:iasis for SMR-appropriate EPZ, including severe'accident 'information developed since NUREG-0396 was p*uqlished in 1978, and information from the design-specific and plant-specific probapilistic risk asses~ments (P.RAs) which will support SMR design and licensing.
A recent example of the continuing dialogue referred to in the NEI white paper is the NRC
- Category 3 public meeting in August 2016 to discuss a performance-based approach to EP for SMRs and ONTs. The participant feedback, as summarized in a September 2016 NRC memo, is important to note [9]:
Overall, the feedback from participants was in support of the staff proceeding with a performance-based approach for EP, indicating that it will be more effective because it will focus on achieving desired outcomes. Participants also favored the approach as one that allows for innovation, noting that it should have enough flexibility to accommodate and account for a broad range of sequence of events of various SMR and non-light-water reactor (non-LWR) designs. Additionally, attendees expressed gratefulness for the NRC's initiative in considering a performance-based approach at this time.
EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 6-1 April 2017
Other important aspects of this meeting were summarized as follows:
Specific feedback highlighted the need for NRC to ensure that a performance-based approach would assess: capabilities of the licensees to maintain their emergency plans; adequacy of communications with off-site responders and other interested stakeholders; staff proficiency; and, the availability of facilities and equipment. It was acknowledged that this should be done through inspection and oversight of drills and exercises at a pre-determined frequency. It was also suggested that the validity of the performance indicators be inspected on a periodic basis similar to the current EF\\ Re~ctor Oversight Program (ROP) Performance Indicator inspection methodology. With respect to inspection and enforcement, feedback supported the use of a program similar to the ROP. Performance indicators submitted could be inspected on a periodic basis similar to approaches used now and could include a review of data collection and verification of recording. However, it was rioted that an appropriate approach to enforcement would be necessary to ensure accountability for inadequate performance.
Participants also pointed out the need for 'd~terminir:ig**an appropriate process for changes to EP plans, similar to the current 10 CFR 50.54(q) process. *The staff responded that this would b~. addressed as the' rule language and guidance documents would be develope~C The *potential need for an entire new suite of guidance documents, including.the change process, w~s the only disadvantage identified by particip;a_nts as it woulp require-additional Lip".front work to reflect the new approach.., Participants responded favorably to the need for this additional
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6.2 Question*s for Public Comment I
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The NRC.. welcomes commenJs/~n any,a~pect of this draft regulatory basis but is particularly interes_ted in obtaining additional information related to the following questions in these categor1es (please be as.~pecific a~ pqssible in your responses):
Scope of the Draft Regulatoh, Basis
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(1)
Is the NRC cqnsidering an appropriate approach for each objective described in the draft regulatory b~sis?
(2)
Section 3 of the draft regulatory basis discusses the regulatory concerns the NRC expects to address* through rulemaking. Section 4 presents the intended regulatory changes to address those regulatory concerns and discusses alternatives to rulemaking considered by the staff. Are there other regulatory concerns within or related to the scope of the rulemaking efforts (see Section 4) that the NRC should consider? Are there other approaches or alternatives the NRC should consider to resolve those regulatory concerns?
(3)
Are there any other alternatives EP for SMR and ONT for beyond those discussed in the draft regulatory basis that the NRC should consider?
EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 6-2 April 2017
(4)
Are there other EP related issues that the staff should consider in further developing this
. regulatory basis?
(5)
Is the scope of facilities to be included under the ONT umbrella (see Section 1.1) appropriate or can you suggest additions or deletions and the associated basis or rationale?
Performance-Based Approach (1)
(2)
(3)
What are the benefits and drawbacks of a performance-based EP approach, other than those described in this draft regulatory basis documenP*
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Should NRC continue research to establish perfqrman*9e-based criteria in the EP area? Examples of such research are in SECY.:'.14-0038.
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Is it appropriate to establish combined risk..:infqrmed and*-.p~rformance-based criteria, and can you suggest EP areas or mett:iods where they could*-~uccessfully be implemented?
Regulatory Impacts
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(2)
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Section 5 of the draft regula~ory __ basi_s presents ttie s~affs initial consideration of costs and other effects for several Rey:aspects of the potential regulatory changes. This initial assessment is limited; therefore, the staff is seeking-,d~ta and input relative to expected or unintentional eff~_cts from the desired *reg!,Jlatory cha'nges._ What would be the potential effects-6n stakeholders, sl!ch as applicants, lice*ns_ees, and the public, from implementing any, of the.9esired regulatocy 'changes,described in this draft regulatory basis? The staff i_~ also se1eki,ng comm,ents oh reasonable cost estimates for implementation q_f the EP r~g\\Jlations for:__SMRs and ONTs, including one-time startup
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What woiild*t~e cost.be.for.*l;ce-~~~es unde/1 ~-,CFR Part 52, 11ucenses, Certifications i }md Approvals fee *Nuclea'r f6wer Plan.ts/? to be licensed under the proposed p~rformance-based,ER apprqi:ich? What would be the cost difference between this new EP approach and the current ER approach in 10 CFR Part 50?
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(3)
What effe9ts, other thari, cost, would result from the rulemaking action under consideration?
l Cumulative Effects of Regulation (1)
In light of any current or projected CER challenges, what should be a reasonable effective date, compliance date, or submittal date from the time the final rule is published to the actual implementation of any new proposed requirements, including changes to programs, procedures, or the facility?
(2)
If current or projected CER challenges exist, what should be done to address this situation? For example, if more time is required to implement the new requirements, how much time would be sufficient, and why is such a timeframe necessary?
EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 6-3 April 2017
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(3)
Do other regulatory actions (e.g., orders, generic communications, license amendment requests, inspection findings of a generic nature) by the NRG or other agencies influence the implementation of the potential proposed requirements?
(4)
Are there unintended consequences? Does the potential proposed action create conditions that would be contrary to the potential proposed action's purpose and objectives? If so, what are the consequences and how should they be addressed?
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EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 6-4
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April 2017
- 7. NEXT STEPS 7.1 Steps toward Rulemaking After this draft regulatory basis is published in the Federal Register, it will be available during a 75-day period for comment from stakeholders, including industry (vendors and utilities),
governmental and nongovernmental organizations, and individuals. The public is encouraged to include responses to the questions in Section 6.2.
No significant policy or legal issues were identified during the development of this draft regulatory basis that would need to be resolved before coml)Jln~ing a rulemaking. The Advisory Committee on Reactor Safeguards will review th~/propbsed rule, and the final rule.
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The process for rulemaking is given in NRG Directivefiaridbb~R 6.3 [10], which should be referenced for more information on next steps. In,addition to th'e.._regulatory basis, a regulatory analysis is required. As noted in the handbook.Alie re'gulatory analysis."systematically provides complete disclosure of relevant information s~ppqrting a regulatory de~isi~n. The conclusions and recommendations included in a regulatory._basis document are neither final nor binding, but are int~n~ed to enhance the soundness of deci~iQ,n' making py-~RC manilg~rs._and the Comm1ss1on."
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NRC Directive Handbook 6.3 also de~crib.es-the responsipilitles and makeup of a working group for rulemaking that might be considers~:[. it describes the responsibilities and makeup of a steering committee for rulemakings "that are UllU$Ually controvirsi_al or complex and those for which the implementation-responsibilitie~*,cut across.several divisions or offices." The handbook also describes how public partjclpation will'take place.. -.. '..
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This rulemaking is con~ia~red to br of mediurll. pri.ority and isb'eing tracked by the Commission.
As such, this rulemaking ls included ioJhe NRC*pudget process. Budgeted activities include developing tlJe prop()Sed ar.i~*fioal rule *paCki:)ges,"-~ta!(eholder interaction, guidance developr:nent, and~developmeot of inspectiQri"procedu'res.
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7.2 *,.. Future Guidance Documents
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Rulemaking wo.uld.require con*sicieration *of new guidance documents. A new RG would be developed to desG_ribe an acceptaqle approach for SMR and ONT licensees to implement the EP requirements irMt,e-proposed rule. The RG would be developed as a standalone guidance document using concepts* drpWn from the existing guidance documents. The RG would describe one acceptabl(:} way for' *these facilities to implement an EP program to assure that adequate protective measures can and will be taken in the event of a radiological emergency. The draft RG will be made available for public comment when the proposed rule is issued. Existing guidance documents will remain applicable to large LWRs.
EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 7-1 April 2017
- 8. REFERENCES
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- 5.
- 6.
- 7.
- 8.
- 9.
- 10.
U.S. Environmental Protection Agency, "Manual of Protective Action Guides and Protective Actions for Nuclear Incidents," EPA-520/1-75-001, September 1975.
U.S. Nuclear Regulatory Commission, "Reactor Safety Study: An Assessment of Accident Risks in U.S. Commercial Nuclear Power Plants," WASH-1400 (NUREG 75/014), October 1975.
Nuclear Energy Institute, "White Paper: Proposed Methodology and Criteria Establishing the Technical Basis for Small Modular R~actqr Emergency Planning Zone,"
December 2013.
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U.S. Environmental Protection Agency, "Manu.al of,PtoJective Action Guides and Protective Actions for Nuclear Incidents," EPA400/R-16/001, November 2016
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U.S. Nuclear Regulatory Commission,. Safety Evaluation R~port Related to SHINE Medical Technologies, Inc. Construction P~rmit Application for.a}v1edical Radioisotope Production Facility," NUREG 2189, Aug'ust.2Q16.
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Mazza, Jan, U.S. Nuclear Regulatory Commissidn, memorandum to Mich~el E.
Mayfield, U.S. Nuclear Regtil~tory Cornmission~!'.$u'inmary of September 12, 2015, Nuclear Regulatory Commissibp ~<:! pepartment of.,En~rgy Co-Hosted Workshop on
- Advanced Non-Light Water Reaqtors,..-Oc~ober 1, 2015_. *.,
Tartal, GeorgE}-~.:-~.~: Nu.clear R~gul~tory::ComQ)issi9n>meinorandum to Michael E.
Mayfield, U.S. Nuclear R~gulatory Commissipri, "Surnm*a,ry of June 7--8, 2016, Department of.Energy and,N1:1clear R~gulatciry Commission Co-Hosted Workshop on Advanced Nonl:ight Water Reactors," july7, 2016.
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Nucl~ar ln~ovation Alliance; "Enabling Nuclear. Innovation: Strategies for Advanced
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r,Reactor Lice*nsjng,'.'._June.._7,* ~016.
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Resales-Cooper, Cir:idy, U.S~'Nuclear Regulatory Commission, memorandum to Marissa Bailey-'. U:S. ~uclear R~gulatory <;_ommission, "Summary of August 22, 2016, Public Meeting Jo Discuss a Performance-Based Approach to Emergency Preparedness for Small Modylar Reactor~, arid Other New Technologies," September 15, 2016.
U.S. Nuclear Regul~.Jdry Commission Directive Handbook 6.3, "The.Rulemaking Process," DT-13.:1~. *July 22, 2013.
EP for SMRs and ONTs Rulemaking: Draft Regulatory Basis 8-1 April 2017