ML20149D331

Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission.Draft Report for Comment

ML20149D331
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Issue date:	08/31/1993
From:	NRC
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References
NUREG-BR-0058, NUREG-BR-0058-R02-FC, NUREG-BR-58, NUREG-BR-58-R2-FC, NUDOCS 9309210009
Download: ML20149D331 (32)

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1 Regulatory Analysis j Guidelines of the  !

U.S. Nuclear Regulatory l Commission 1 :

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e a E E United States Nuclear Regulatory Commission "g,.... ,/ l i

Regulatory Analysis l Guidelines of the '

U.S. Nuclear Regulatory i Commission  ;

Draft Report for Comment l l

August 1993 .

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ABSTRACT 1he Guidelines are the Nuclear Regulatory Commis- (2) changes in NRC regulations and procedures since sion's (NRC) policy-setting document with respect to 1984, especially the backfit rule (10 CFR 50.109) and the regulatory analyses.' Regulatory analyses are performed Policy Statement on Safety Goals for the Operation of by the NRC to support numerous NRC actions which Nuclear Power Plants (51 FR 30028, August 21,19S6),

affect reactor and materials licensces. As such, the docu- (3) advances and refinements in regulatory analysis tech-ment contains a number of policy decisions that have niques, (4) regulatory guidance for Federal agencies is-broad implications for the NRC and its licensecs. sued by the Administrative Conference of the United States and the Office of Management and Budget, and  !

lhis revision reflects: (1) the NRC's accumulated expe- (5) procedural changes designed to enhance NRC's regu- r rience with implementing the previous Guidelines, latory effectiseness.

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TABLE OF CONTENTS Page ABSB1ACF .... . . ... .. ... . .. ... . ...... .... . .. . ..... .. . . ...... iii FOREWORD . . ... .. .. .. .... . . . . .... ............. .................. vii ACRONYMS... . . .. . ... . .. . .. .. . .. . .. . ... ...... . .. ......... ix 1 INTRODUCDON . . . .. . .. . .. ..... . . ........ .... .. ..... 1 2 DISCUSSION . . .. ... .. . .. ... . .. . ...... . .... ... . .. . 3 2.1 Purpose of Regulatory Analysis . . .. . .. ... . ....... . . ... . . .... 3 l 2.2 General Coverage . . . . . .. . . .. .. .... .. .. .. .... . ..... 3  ;

2.3 Proposed Actions Subject to the Backfit Rule and CRGR Review . . .... ... ...... . . ... .. 4 ,

3 SAFETY GOAL EVALUATION .. .. .. .... . . ... ....... ....... . . ....... ... 6 3.1 Safety Goal Decision Criteria . . . .. ... . . . ..... .... . .. ... ... . .... . 6  ;

3.2 Procedure . ... ... . . . .... . . .. .... . ... .. .. ... .. ..... . 6 -

3.3 Interim Guidance for Implementation . . . ...... .. . ... .. .. ...... . ......... .. 6 4 ELEMENTS OF A REGULATORY ANALYSIS. . .. . ..... ... . .. ... ...... ........ 12  !

4.1 Statement of the Problem and Objective . .. .... . ... .. .. ... ... . .. . ... 13 4.2 Identification and Preliminary Analysis of Alternative Approaches . . . ... .... .......... 13  ;

4.3 Estimation and Evaluation of Values and Impacts . . . . . . . . . . .. . ..... .. ...... .. 14 .;

4.4 Presentation of Results .. . ... ... ....... . . . . .. .. .. ... ... ... .. 19 l 4.5 Decision Rationale for Selection of the Proposed Action . . . . . .. . . ... .... ....... 20 4.6 Implementation . . .. . ... ... . . ... . .. . . . . . ... ... 21 <

t 5 RELATIONSillP TO OTHER PROCEDURAL REQUIREMENTS . . . .. .... .. . ....... .. 22 5.1 Paperwork Reduction Act .. ... . ..... . . .. ... ... . .. . . ...... 22 i 5.2 Regulatory Flexibility Act .. . .. . . .. . .. . .... . . . .... .. .. 22 'i

' 23 5.3 National Environmental Policy Act . . . .. . ....... . .. .. . .. .. ........  ;

5.4 Information Requests Under 10 CFR 50.54(f) . . . ..... .... ..... . . .. . ........ 23 i 5.5 Supporting Analysis for Compliance and Adequate Protection . .. . ... .... ............ 23 REFERENCES. .. . . . . . . . .. .... .. . . ... ....... . .... .... . 25 i i

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6 FOREWORD 1

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This document will be used in the evaluation of proposed by the duc date published in the Federal Register Notice.

actions by the U.S. Nuclear Regulatory Commission that Comments received after the duc date will be considered may be needed to protect public health and safety. The to the extent practical. Comments should be sent to the l evaluation is intended to aid the staff and the Commission Chief, Rules and Review Directives liranch, Division of '

in determining whether the proposed actions are needed. Freedom of Information and Publications Services, Mail to provide adequate justification, and to provide a clear Stop P-223, U.S. Nuclear Regulatory Commission, and well-documented explanation of why a particularac-Washington, DC 20555-0001. Further technical informa-tion was recommended.

tion can be obtained from Mr. Ilrian Richter, Office of '

4 Any interested party may submit comments on this docu. Nuclear Regulatory Research, Mail Stop N13S-129, U.S.

ment for consideration by the staff. To be certain of con- Nuclear Regulatory Commission, Washington, DC 1 solidation, comments on this document must be receivc d 20555-0001. Telephone (302) 492-3763.

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I ACRONYMS  ;

ACRS Advisory Committee on Reactor EO Executive Order Safeguards FR Federal Register ACNW Advisory Committee on Nuclear Waste FSAR Final Safety Analysis Report  ;

BWR lloiling water reactor INPO Institute of Nuclear Power Operations C/B Cost / Benefit NRC U.S. Nuclear Regulatory Commission -

CCFP Conditional containment failure NUMARC Nuclear Management and Resources probability Council CDF Core damage frequency OMB Office of Management and Budget CFR Code of Federal Regulations PRA Probabilistic risk analysis i PWR Pressurized water reactor CRGR Committee to Review Generic Requirements RA Regulatory Analysis i

EDO Executive Director for Operations U.S.C. United States Code EIS Environmental Impact Statement V/I Value/ Impact t

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ix NUREG/BR-0058, Rev. 2

1 INTRODUCTION The Regulatory Analysis Guidelines (" Guidelines") will adheres to the P:inciples of Good Regulation as deline-be used in the evaluation of proposed actions by the ated by former Chairman Carr in his January 17,1991, Nuclear Regulatory Commission (NRC) that may be announcement to NRC employees.1 These principles, needed to protect public health and safety. The evalu- which serve to guide the agency's decision making proc-ation is intended to aid the staff and the Commission in ess, are independence, openness, efficiency, clarity, and determining whether the proposed actions are needed, to reliability.

provide adequate justification, and to provide a clear and well-documented explanation of why a particular action The original version of these Guidelines (NUREG/

was recommended. These Guidelines establish a frame _ B R-0058) was issued in January 1983. In December 1983, work for (1) analyzing the need for and consequences of a

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NRC issued "A Handbook for Value/ Impact Assess-proposed regulatory action,(2) selecting a preferred al. ment," NUREG/CR-356g2 (Ref. 2). The basic purpose ternative, and (3) documenting the analysis in an organ. of the 1983 llandbook was to set out systematic proced-ized and understandable format. The resulting document urcs for performing value/ impact assessments. Revision 1 is referred to as a Regulatory Analysis. to NUREG/HR-0058 was issued in May 1984 (Ref. 3) to include appropriate references to NUREG/CR-3568.

This revision (Revision 2)is being issued to reflect (1) the Although the NRC does not have a statutory mandate to NRC's accumulated experience with implementing the conduct regulatory analyses, it voluntarily began per- previous G uidelines, (2) changes in NRC regulations and forming these types of analyses in 1976. The intent in procedures since 1984, especially the backfit rule (10 conducting regulato:y analyscs is to ensure that the CFR 50.109) and the Policy Statement on Safety Goals NRC's decisions that impose regulatory burdens on licen~ for the Operation of Nuclear Power Plants (Ref. 4),(3) secs are based on adequate information regarding the advances and refinements in regulatory analysis tech.

extent of these burdens and the resulting values (benc~ niques (4) regulatory guidance for Federal agencies is-fits), and that a systematic and disciplined process is fol' sued by the Administrative Conference of the United lowed that is also open and transparent. The ultimate States (Ref. 5)and the Office of Management and Hudget objective of this regulatory process is to ensure that all (OMB) (Ref. 6), and (5) procedural changes desigm I to regulatory burdens are needed, justified, and minimal to enhance PRC's regulatory effectiveness? Subseq: :o achieve the regulatory objectives. publication of NUREG/CR-3568 and revism of NUREG/HR-0058, the Commission issued its Policy The regulatory analyses prepared before 1983 were Statement on Safety Goals for the Operation of Nuclear termed value/ impact analyses and were prepared accord. Power Plants. His policy statement presents a risk-based ing to value/ impact guidelines issued in final form in philosophy to be used by the NRC staff as part of their December 1977 (S11CY-77-388A). In February 1981, regulatory analysis process for proposed actions that may President Reagan issued Executive Order 12291 (Ref.1) have an impact on commercial nuclear power reactors.

that directs all executive agencies to prepare a Regulatory The Commission's safety goal policy provides a " safety Impact Analysis for all major rules and states that regula. first" test that gives added strength to the regulatory l tory actions are to be based on adequate information decision-making process for new requirements that are concerning the need for and consequences of proposed considered and justified as safety enhancements applica-actions. Moreover, the Executive Order directs that ac. ble to more than one nuclear power reactor. Specifically, tions are not to be undertaken unless there is a positive application of this philosophy will minimize the number net value to society. NRC, as an independent agency,is of occasions that resources are spent on conducting ex-not required to comply with the Order. However, the tensive regulatory analyses that later determine a pro-Commission noted thal its established procedures for the posed action is not justified because the incremental review of its regulations included an evaluation of pro- safety benefits would not substantially improve the exist-posed and existing rules m a manner consistent with the rite pnneipics are set out at p. 3 in the mo Nuc Annual Report, Regulatoty Impact Analysis provisions of the Executive NURI G-1145. Vol. 7. July 1991.

Order.The Commission determined that the clarification rIn document is con enny undcrgoing revision and will tentaiwely be and formalization of the NRC value/ impact procedures  !! d'd ih' Rmd"99Anu!vsis rechnicul tu aluurion Handbook. 'Ihe re-then in place for analysis of regulatory actions would enhance the effectiveness of NRC regulatory actions and further meet the spirit of EO 12291. In performing a i'"l((,T^Mm"[tll"'[4*M$'$g"l3 eN,'M"e""d ne '$.,*f' Generic RequirementHCIM R). It is the NRCN intent that. for these regulatory analysis, as in all Federal activities relating to  %%"cM"'lMhM""y,d""Q*$"gM'/j"Q"L

l the protection of the public's health and safety, the NRC (Ref. 7) wahout a need to prepare separate submiwions.

1 1 NUREGiHR-0058, Rev. 2

l ing level of plant cafety. Ily defining a clear level ofir.cre- sion making, and special requirements for proposed regu-mental safety for nuclear power plants, the safety goal latory actions involving backfits. Chapter 3 discusses the 4

evaluation to be inch:ded in the regulatory analysis pro- relationship of NRC's safety goals for nuclear power vides the staff with direcdon in deciding whether no fur- plant operations to regulatory analyses. Chapter 4 pre-ther backfits are warranted. Thu; the safety goal evalu- sents the format that should be followed in preparing a ation can truncate the need for further analysis. regulatory analysis document. *Ihis chapter includes sum- )

Therefore, the safety goal analysis discussed in Chapter 3 mary guidance on estimating and evaluating the values I of this document is to be addressed as early as possible in and impacts of alternative regulatory actions and selec- l' the regulatory analysis process for safety enhancement tion of the proposed action. Information is also included initiatives, in Chapter 4 on the required contents for regulatory  ;

analyses for proposed generic backfits and for actions l This document comprises five chapters that are further subject to review by the Committee to Review Generic J subdivided into several sections. Chapter 2 of this docu- Requirements (CRGR). Chapter 5 discusses certain pro- '

ment discusses the purpose and coverage of the Guide- cedural requirements that relate to the regulatory analy- I lines. The discussion includes information on when a sis process. including the impact of the Paperwork Reduc- i regulatory analysis must be prepared for a proposed regu~ tion Act of 19S0 and the Regulatory Flexibility Act of j latory action, the role of regulatory analysis in NRC deci- 1980. i i

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2 DISCUSSION l l

2.1 Purpose of Regulatory Analysis 2.2 General Coverage The statutory mission of the NltC is to ensure that civilian Regulatory analyses are performed by the NitC to sup-uses of nuclear materials in the United States-in the port numerous NitC actions affecting reactor and materi-operation of nuclear power plants and related fuel cycle als licensees. The llegulatory impact Analysis Guide-facilities or in medical, industdal, or research applica- lines" of Executive Order 12291 (Itef.1) require that a tions-are carried out with proper regard and provision regulatory analysis be prepared for all major proposed for the protection of the public heahh and safety, prop- and final rules.5 NltC policy requires regulatory analyses erty, environmental quahty, common defense and secu- for a broader range of regulatory actions than for those rity, and in accordance with applicable antitrust laws. that would be covered by EO 12291. In general, each .

Accordingly, the principal purposes of a regulatory analy- NitC office should ensure that all rnechanisms used by  ;

sis are to help ensure that: the NitC staff to establish or communicate gencric req-uirements, guidance, requests. or staff positions, which ,

e NitC's regulatory decisions made in support of its would result in the use of resources by licensees and staff statutory responsibilities are based on adequate in- of the NitC or an Agreement State, include an accompa- l formation concerning the need for and conse- nying regulatory analysis. These mechanisms include 4

quences of proposed actions. rules, bulletins, gencric Ietters, regulatory puides, orders, ,

standard resiew plans, branch technical positions, and o Appropriate alternative approaches to regulatory standard technical specifications.

objectis ts are identified and analyzed.

llegulatory analysis requirements for a given action may

• There is no clearly preferable alternative to the pro- be climinated at the discretion of the Commission, the posed action. lido or a Deputy Executive Director, or the responsible NitC Office Director. A factor that could influence this

• Proposed actions subject to the backfit rule (10 CFIt decision is the degree of urgency associated with the regu-50.109; [and not within the exceptions at 10 CFR latory action. For example, urgent NRC bulletins and  ;

50.109(a)(4)] provide a substantial increase in the orders may need to be issued without regulatory analyses.  ;

m crtdl protection of the public health and safety or in other regulatory applications, case-specific circum- I the common aciense and security and that the direct stances could justily the preparation of a more limited I and indirect costs of implementation are jusufted in regulatory analysis. A regulatory analysis should be lim- i view of this substantial inacase in protection- ited only in terms of depth of discussion and analysis, not m reduction of the scope of the regulatory analysis nor in The regulatory analysis is intended to be an integral part the need to justify the proposed action.  !

of Ni(C decision making that will systematically provide complete disclosure of the relevant information support- Generic actionse that may not need a regulatory analysis ,

ing a regulatory decision d The process should begin w hen include notices, policy statements, and generic !ctiers  ;

, it becomes apparent that some type of action to address that only forward information and do not present new or  !

an identified problem may be needed. revised stalf positions, impose requirements, or recom- ';

mend action. Generic information requests issued under  ;

, The regulatory analysis process is not to be used to pro- 10 CFR 50.54(f) require a specificjustification stateracnt I duce after-the-fact rationalizations tojustify dectsions al- and are reviewed by the CRGR, but do not require the  !

ready made, nor should it be used to unnecessarily delay type of regulatory analysis discussed in this document.  ;

regulatory actions. Initial efforts should be focused on the The content of such a justification statement is available '

nature, extent, and magnitude of the problem being ad- in NRC Management Directive 8.4 (Ref. 8). New require- >

dressed. why NRC action is required, and identification of

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alternative solutions. Detailed information gathering and eE012nl acfmes a major rulc as any rccula tion that is htcly toicsult in (1)an annual ef fcet on the cconomv of $ 100 nulhon or mor e,(2)a ma.

analysis activities should be focused on the most promis- jo increase m costs or prices for cohsumers mdmdualindustries. red-ing alternatives. cyalMiate. or local gwonnent apnoes or geopaphic repons, o@

sipuhcant adverse cffccts on competit '

on, employment, mvestment, -

ps oduc tn ity. m navation. or on the abi ity of IJm ted Statev hased cnter.

poses to compete woh foreign based enten pnses in domestic or export 4

"The conclusions and recommendations included in a regulatory analysis mar ke ts.

document are nnther fmal nor f undmg. but rather are intended to t n-hance the soundness of dcchion maki5g by NRC management and the 'In thesc Guidchnet.. the tenn generic actions refers lo thosc actions that Commission. af fect all, sevn al. oi a class of hccmces.

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ments affecting certified plant designs would be justified some of the material. It may be appropriate to address the through the notice and comment rulemaking process. supplement or revision in the transmittal memorandum i Also, regulatory analyses are not required for require- to the CRGR (and include the supplement or revision as ments arising out of litigation, such as discovery in a li- an enclosure) rather than reprinting the regulatory analy-censing proceeding. sis.

Special requirements apply to regulatory analyses pre-2.3 Proposed Actions Subject to the pared in conjunction with proposed backfitting of produc-Backfit Rule and CRGR Review tion or utilization facilities. The term *backfitting" is de-fined at 10 CFR 50.109(a)(1). The terms " production Regulatory actions that are subject to the backfit rule facility" and " utilization facility" are defined at 10 CFR ,

and/or CRGR review require that specific questions and 50.2. A nuclear power reactor is a utilization facility.  !

issues be addressed. These Guidelines have been devel. Production facilities include reactors designed or used for '

oped so that the preparation of a regulatory analysis in the formation of plutonium or uranium-233, certain ura- ,

conformance with these G uidelines will meet the require- nium enrichment facilities, and nuclear material reproc-ments of the backfit rule and provisions of the CRGR essmg facihties. j Charter (Revision 5, April 1991) (Ref. 7). However, it should be noted that relaxations of requirements are not The backfit rule [cf.10 CFR 50.109(a)(2)] prescribes the subject to the backfit rule nor to the safety goal analysis preparation of an analysis for proposed plant-specific and process and criteria contained in Section 3 of these generic backfits. The required analysis for generic back-Guidelines. A presentttion is needed for the cost savings fits is to be considered a regulatory analysis and should be from relaxed requirements, but no balance is required. prepared according to these Guidelines. In addition, The values side of the equation does not need to be plant-specific backfits require justification statements 2 shown, but the fact that the relaxation does not adversely similar in nature to a regulatory analysis.To the extent to affect the public health and safety and that the protection which the Guidelines are applicable to plant- specific continues to be adequate needs to be presented and dis- reg'drements, it should be applied in these circumstances cussed. as vell.

The CRGR has the responsibility to review and recom. Backfitting can apply to one facility (" plant-specific back-mend to the EDO approval or disapproval of require- fitting") or to multiple facilities (" generic backfitting").

ments or staff positions to be imposed by NRC on one or These Guidelines are intended for both generic and more classes of power reactors.Section IV of the CRGR plant. specific backfits. Proposed plant-specific backfits i Charter specifies the information to be submitted to the are subject to the requirements in NRC Management l CRGR as part of its review process. This information is Directive 8.4 (Manual Chapter 0514-043) (Ref. 8). This l incorporated in Chapter 4 of these Guidelines. Directive contains plant-specific regulatory analysis req-uirements and thus, when preparing a plant-specific

'Ihe Regulatory Analysis Technical Evaluation Hand. analysis, this Directive should be consulted.

book provides a standard table of contents for a regula-tory analysis and indicates where cach item of information Backfitting can arise through a variety of mechanisms required by the CRGR Charter may be found in a regula- including rulemakings, bulletins, generic letters, and tory analysis. regulatory guides. Further description of the backfitting 1 process is in "Backfitting Guidelines." NUREG-1409 When a regulatory analysis has been prepared in accor. (Ref. 9). NRC Management Directive 8.4 is included as dance with these Guidelines and the associated Hand. Appendix B in NUREG-1409.

book it will not be necessary to prepare a separate docu- .

ment to address the information required for CRGR A regulatory analysis involving a value/ impact determina-  !

review, except for the CRGR requirement relating to the tion is necessary for all proposed plant-specific and ge-ccmcurrence of affected program offices or an explana- neric backfits except when one of the three conditions tion of any nonconcurrences.This exception may be ad- identified at 10 CFR 50.109(a)(4) applies, i.e.,

dressed in the transmittal memorandum forwarding the matter to the CRGR for review. i. That a modification is necessary to bring a facility into compliance with a license, a Commission re-After a regulatory analysis has been prepared and quirement. or a written commitment by the ticensee; printed, it may become necessary to revise or supplement or NUREG/BR-0058, Rev. 2 4

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ii. That regulatory action is necessary to ensure that the the objectives of and reasons for the backfit, as well as the facility provides adequate protec! ion 7 to the health reasons for invoking the particular exception [10 CFR and safety of the public and is in accord with the 50.109(a)(6)]. Procedural requirements for preparation common defense and security; or and processing of the documented evaluation are in NRC Management Directive 8.4 for plant-specific backfits and iii. That the regulatory action involves definn t or re<1e- in Section IV(B)(ix) of the CRGR Charter for generic fining what level of protection to the public iv , backfits.

and safety or common defense and security is re-garded as necessary for adequate protection. A regulatory analysis may also be prepared in these in-stances as a management decision-making tool. In par-If a backfit meets one of these exception criteria, costs are ticular, if there is more than one way to achieve compli-not to be considered in justifying Ine proposed action. A ance or reach a level of adequate protection and it is documented evaluation is to be prepared that includes necessary or appropriate for the Commission to specify the way, costs may be a factor in that decision. A regula-rite level of proiection constituting adequate protection" is to be de- tory analysis that explores the cost effectiveness of the termined on a case-by-case basis. The determination should be based various alternatives under consideration could therefore on plant- and site-specific conoderations and the body of NRC s regu-latory requirements. be valuable to a decision maker.

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3 SAFETY GOAL EVALUATION Assessing the risk of potential changes to public safety has that the substantial additional protection standard of 10 always been a fundamental part of regulatory decision CFR 50.109(a)(3)is met for the proposed action.

making. In the early development of regulations, this assessment was based on qualitative analysis, simple reli- As discussed in Section 2.3 of these Guidelines, relaxa-abihty principles and practices (such as worst case analy- tions of requirements are not backfits and thus do not fall sis), defense- in-depth and the single failure criterion. within the scope of the backfit rule. As a result, relaxa-De frequency or probability of Ihe hazard was not an tions or the climination of requirements are not subject to explicit factor, primanly beca use the overall state-of- the- the safety goal evaluation of this section.

att of probabilistic risk assessment (PR A) technology was not sufficiently adsanced and accepted. Because of the in justifying a proposed backfit under the backfit rule. the advancements made and an increased confidence in PR A, burden is on the staff to make apositim showing that a regulatory activities have progressivelv relied more on the generic safety problem actually exists and that the pro-insights and results from risk assessment. The safety posed backfit will both address the problem effectively goals, which are in an August 19S6 Commission policy and provide a substantial safety improvement in a cost-statement (Ref. 4). are a clear example of this change and beneficial manner.

established a guide for regulatory decision making.

3.2 Procedure He safety goal evaluation is designed to answer the ques tion as to when a regulatory requirement should not be The staff must first determine whether the subject regula-imposed on a generic basis because the residual risk is tory action needs to consider safety goals. The discussion already acceptably low. The intent is that such an evalu- above in Section 3.1 provides guidance for making this ation could climinate some proposed requirements from determination. If a safety goal evaluation is required, the further consideration independently of whether they results of the evaluation will establish whether a regula-could bejustified on a value/ impact (V/l) hasis.The safety tory analysis should be done (Figure 3.1). If the proposed goal evaluation will also scrve the purpose of determining regulatory action meets the safety goal decision criteria, whether the substantial added protection standard of 10 the regulatory analysis should include the results of the CFR 50.109 is met. safety goal evaluation as well as the follow-on value/im-pact analysis. Figure 3.1 depicts all steps performed in a Additionally, it should be noted that the Commission's regulatory analysis that is subject to a safety goal evalu-safety goals reflect a mean value for a class or all U.S. ation. Depending on the results of steps C and D, the reactors as a whole. In this regard, the Commission speci- regulatory analysis ctm be 1crminated. In performing fied in an SRM dated J une 15.1990. that " Safety goals are steps C and D. a PRA should be relied upon to quantify to be used in a more generic sense and not to make the risk reduction and corresponding values of the pro-specific licensing decisions / posed action. However, it is recognized that not all regu-latory actions are amenabic to a quantitative risk assess-De following discussion provides guidance on (1) w hen a ment, and certain evaluations may be based directly on regulatory analysis must include a safety goal evaluation, engineering or regulatory judgment or qualitative analy.

(2) criteria for judging conformance to the safety goals, sis. Additional insights are available in the Handbook and (3) the sequence for performing the analysis. beyond the implementation guidance that follows.

3.1 Safety Goal Decision Criteria 3.3 Interim Guidance for NRC's safety goal policy addresses a level of acceptable residual individual risk from operation of power reactors This interim guidance is to allow the staff to gain experi-judged to be lower than that associated with adequate ence in the application of the safety goals and to permit protcction. He risk level associated with adequate pro- consideration of the goals to the extent practicable, pend-tection is that above which ecmtinued operation would not ing availability of additional data and decisions to permit be allowedJrhe safety goal evaluation, as discussed in this more structured decision making. This guidance will be section, is applicah!e only to regulatory initiatives consid- revised as experience and new information dictates. Fac-ered to be generic safety enhancement backfits as defined tors that will be considered include the availability of in the backfit rule (10 CFR 50.109),If the proposed safety PRAs that reflect both internally and externally initiated goal decision criteria are satisfied, it is to be presumed accidents and the current design of all U.S. plants.

NUREG/HR-0058 Rev. 2 6

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Figure 3.1 Regulatory Analysis For Reactor Safety Enhancements A. STNillMENT OF PROBLliM B. ALTERNN11VES C. SAFETY GOAL EVALUNilON:

SUllSTANTIAL ADDITIONALPROTECrlON?

SAFETY GOAL DECISION CRITERIA MET?

I YES I

D. VALUEllMPACT ANALYSIS:

NO VALUES IiXCEED IMPACFS l

YES I

E. PRESENTATION OF RESULTS F. DECISION RATIONALE G. METIlOD AND SCIIEDULE REGU TORY FOR IMPLEMENTNI1ON ACTION 7 NUREG/BR-0058, Rev. 2

In summary, the safety goal evaluations are based upon This cakulation shoulqi be computed on a gencric basis the following broad guidelines: for the class of affected plants. The resulting change in CDF should be representative for the affected class of e Safety goal decision criteria are to be applied only to plants. The selection of the PR A model (or models) and i safety enhancements and evaluated for the affected the associated data base must be identified and justified as class of plants. Safety goals are to be used as a refer- representative of the class. For example, if the class of ence point in ascertaining the need for safety en- affected plants is exclusively " older BWRs," one or more hancements, llowever, the safety goals are not req- PRAs from IPE submittals or that have otherwise been ,

uirements and, with the Commission's approval, conducted for older BWRs should be selected. The <

safety enhancements may be implemented without llandbook that complements these G uidelines includes a strict adherence to the Lomrmssion's safety goal table listing PRAs available for use with staff risk assess- '

poh statement ment codes (IRRAS and SARA) along with some basic e The approach is to be implemented in conjunction attributes of each (e.g., plant type and year of commercial with the " substantial addit ional prot ection" crit erion operation). As a minimum, the merit of the proposed contained in the backfit rule [10 CFR 50.109(a)(3)] actions should be explored and displayed using best-  ;

I and a pplies to 50.109 analyses associated wit h safety available PRA data for multiple plants within the class. ,

enhancements for nuclear power plants. This will result in identification and assessment of the '

range of reduction in CDF as well as an estimation of the e Evaluation of proposed regulatory initiatives for representative change for the class. Uncertainties and consistency with safety goals should iJentify and in- limitations should be addressed qualitatively and to the tegrate related issues under study. Such integration extent practical, quantitatively in the supporting docu- l is essential to the efficient application of staff and mentation for the proposed regulatory action.This would i industry resources. The overall objective is to avoid include, for example, plant-to-plant variabilities within a picccmeal evaluation of issues. class of plams.

The regulatory philosophy involves the concept of de- The risk assessments needed for these safety goal evalu-fense-in-depth and a balance between prevention and ations have a set of key characteristics. Under normal a mitigation. His traditional defensc-in-depth approach circumstances. these should include:

and the accident mitigation philosophy require reliable performance of containment systems. As discussed be-

• The Snalysis should explicitly define the class of low, the safety goal evaluation focuses on accident pre- affected plants and justify the use of specific PRAs

vention, that is, on issues intended to reduce core damage to represent that class, frequency. However, to achieve a measure of balance between prevention and mitigation, the safety goal deci-

• The PRA should reflect the current state of PRA sion criteria established for these evaluations include a technology, and include an analysis of uncertainties.

mechanism for having greater consideration of issues, and associated accident sequences, with relatively poor con.

• The product of the analyses should be mean values tainment performance. and uncertainty estimates.

• The analysis should receive an independent review 3.3.1 Presention of Core Damage Accidents-Com. by staff knowledgeable and experienced in PRA.

parison With Subsidiary Goal for Core Dam- plus reviews by the individual or group which identi-i age Mean Frequency of 10 d/ Reactor Year fied the issue and the group which would be respon-

~ For proposed regulatory actions to prevent or reduce the sible for implementing the resolution.

likelihood of sequences that can lead to core damage

• The analysis should be documented with sufficient j events, the change in the estimated core damage fre-quency8 (CDF) per reactor year needs to be evaluated detail to enable the analysis to be repeated. In addi-tion, sufficient explanatory material should be pro-

, and addressed in the regulatory analysis. The objective is vided to enable the reader to understand the signifi-to ensure that emphasis is placed on preventing core damage accidents.

cance of the calculations and to reconcile the various calculations with engineering judgment. Thus, the event or issue, its relationship to safety, the calc-ulational approach, and all assumptions should bc 1 sted and justified, including choice of base PRA,

• volvmg Core damage the'ioss frebuency in defined as the 1;kelihmd of an accident in-dequate coohng to reactor f aci elements up to and includmg major damace to a reactor core with conse vent release of choice of parameters, source of basic data, any fis on products, but nht necessaray mvolving a brea i of ibe reactor mathematical approximations used, etc. Also, the accident sequences affected should be described and N UREG/11R-0058, Rey, 2 8

,--r---.--- _ - -- -

l 1

explanations of why they re affected should be pro- proposed regulatory change should execed the CDF after vided. the change by at least 1 x 103)in order to justify proceed-ing with further analyscs. This safety goal decision crite-e 'Ihe documentation should not present calculational rion was selected to provide some assurance that the PRA results with more significant figures than are appro- and data limitations and uncertainties, as well as the priate. More than one significant figure in the man- variabilities among plants, will not climinate issues war-tissa is not appropriate in most cases. (It should be ranting regulatoay attention. This does not .mean that in noted, however, that tf intermediate results are pre- all cases that a proposed safety enhancement of at least inted, a reader attempting to use these intermedi- 1 x 10J will subsequently prove to be justified for imp!c-ate results in duplicating the calculation may not mentation after more detailed assessments are perform calculate exactly the same fmal results due to round- in accord with Chapter 4. In this regard, the effect of off error.) uncertaintics should be considered and discussed.

The Handbook accompanying these Guidelines provides After the significance has been determined as measured a more complete and detailed discussion of the key char- by the estimated reduction in CDF of the proposed action acteristics of risk assessments available to be used for for the affected class of plants, guidance on further staff these safety goal evaluations.

action is as follows:

In comparing the estimated resulting change in CDF for Estimated Reduction the affected class of plants, contributions from both inter- In CIF StayAction nal and external events should be considered to the exient that information is available and pertinent to the issue. > 10 */ reactor year . Proceed directly to the However, the uncertaintics associated with certain exter-V/I portion of the nal event risk contributions (especially seismic) can be regulatory analysis on a relatively large. Therefore, to supplement any available high priority basis.

quantitative information, qualitative insights should be used for issues involving external events' 10 *-10J/ reactor year -

The decision whether to proceed to the V/I For the purpose of evaluating regulatory initiatives portion of the regulatory j against sr.fety goals, the magnitude of the change in CDF analysis is to be made by should be considered in concert with the determination of the responsible Division whether the substantial additional protection criterion of Director. (see Figure 3.2).

the backfit rule is met. Specifically, a single, common criterion is to be used for determining whether a regula-10J/ reactor year .

Terminate further analysis tory initiative involving a reduction in CDF(1) meets the unicss the Office Director

" substantial additional protection" standard identified in directs otherwise based the backfit rule and (2)is appropriate considering the upon strong engineering subsidiary safety goal of 103 in mean core damage fre-or qualitative justtfication quency per reactor year.

(see Figure 3.2).

In light of the inherent uncertainties of current PRA analysis, and during the initial period of trial use, a reduc- 'ihe evaluation of CIF reduction provides a calibration tion in CDF will be considered to be clearly " substantial" on the significtmcc of the proposed regulatory action. If if the reduction is equal to or greater than 103. If the the initiative results in a small change in CDF (less than reduction in CDF is 10 percent or more of the subsidiary 1 x 103/ reactor year), the regulatory analysis should in safety goal of 103 in mean core damage frequency per general proceed only if an alternative justification for the reactor year but less than 103, consideration should be proposed action can be formulated. One class of accident given to the probability of containment failure before a sequencing that should receive further consideration conclusion is reached on whether the reduction in CDF even if the reduction in CDF is less than 1 x 10J/ reactor constitutes substantial additional protection. As dis. year is that involving the potential for early containment cussed below and as illustrated in Figure 3.2, this means failure or containment bypass (discussed in more detail that, with certain exceptions, as discussed later, regula- below). However, there may be other special circum-tory initiatives involving actions to prevent core damage stances that should be analy7ed.'lhe staff should forward should result in a reduction of at least 1 x 103 in the the issue (and include sufficient supporting information) evimated mean value CDF (i.e., the CDF prior to the for Office Director review.

i 9 NURI G/HR-0058, Rev. 2

i Figure 3.2 Safety Goal Decision Criteria 1E-03 PROCEED TO V/I PORTION PROCEED TO V/I PORTION OF y OF REGULATORY ANALYSIS REGULATORY ANALYSIS

• 2 (PRIORITY) ou 1E-04 8~ MANAGEMENT DECISION PROCEED TO V/I PORTION gy WHETHER TO PROCEED OF REGULATORY ANALYSIS Mz WITH V/I PORTION OF ca $ REGULATORY ANALY, SIS 0 O' IE-05 k$

$" MANAGEMENT DECISION y NO ACTION WHETHER TO PROCEED WITH

$ V/I PORTION OF REGULATORY 2 ANALYSIS O 1E-06 1E-02 1E-01 1 ESTIMATED CONDrFIONAL CONTAINMENT FAILURE PROBAUll.ITY"

• A determination is needed regarding adequate protection or compliance; as a resuh, a value/ impact analysis may not be appropnate.

" Conditional upon core damage accident that releases radionuclides into the containment (see Section 3 3.2)

If it is not possible to develop adequate quantitative sup- ance. The measure of containment perfom1ance to be porting information for the proposed action, a qualitative used in safety goal evaluations is the conditional probabil-analysis and perspective should be provided To the ex- ity of early containment failure or bypass S The safety goal tent practical, these points and insights should be related decision criteria described in Figure 3.2 are subdivided to to the safety goal decision critcria. For example, how does require dtfferent consideration of issues / accident se-the proposed initiative affect the CDF and to what ex- quences with the CCFP greater than or less than 0.1. A tent? How should the risk and the expected improve- CCFP value of 0.1 is consistent with Commission guid-ment be measured or estimated? ance on containment performance for evolutionary de-signs. In effect, the use of the CCFP reduces the priority

'lle safety goal decision criteria are in terms of a mean for of or eliminates the additional study of issues with associ-the class of plants. Ilowever, the range within the class of ated CCFP's of less than 0.1.

the risk reduction is also important. Consequently, when performing safety goal evaluations, if specific plants are The safety goal decision criteria provided here are based identified as " outliers," the situation should be noted for upon the recognition that the severe accident risk to the specific regulatory follow-up (e.g., for evaluations regard- individual is dominated by the overall frequency of the ing potential plant-specific backfits). following kinds of scenarios:

o 'Those involving core damage and release into an 3.3.2 Additional Consideration of Containment Per- intact containment with early containment failure formance occurring The previous section focuses on accident prevention, that is, on issues intended to reduce core damage frequency.

To achieve a measure of balance between prevention and SCCI'P in this context is a probability of early containment failure or mitigation, the safety goal decision critcria established for Ne^f$'," 'f' "'j';jaNjnSfaild)eb *s"ENEg"$*r"e$ "')iN'S safety goal evaluations include a mechanism for having few mmutes of reactra vessel breach for PWRs and those failures oc-greater consideration of issues, and associated accident cuninpel re or within(e2 g.,

hours of vessel breach for BWRs. Contain-ment ypass failures interfacing-system loss-of-coolant acci-sequences, with relatively poor containment perform- dents) are categonzt-d separately from early failures.-

NUREG/BR-0058, Rev. 2 10

• Those invohing core damage and for which the con- 33.3 Summary of Safety Goal Decision Criteria tainment system is breached as a result of accident Guidance phenomena cither prior to or early in the core dam-age or melt progression The safety goal decision criteria discussed in these sec-tions have been summarized in Figure 3.2, which graphi-cally illustrates these critcria and provides guidance as to e Those involving pre-existing conditions that cause when staff should proceed to the value/ impact portion of loss of containment integrity prior to core damage the regulatory analysis and when a management decision (e.g., large openings) is needed.

Responsible management should review the results and e Those for which containment is bypassed entirely the overall uncertainty and sensitivity of these estimates, and have high probability of causing core damage to A judgment should be made whether substantial addi-occur (intersystem LOCA). tional protection would be achievable and whether con-tinuation of the regulatory analysis is therefore war-ranted.

It should be noted that the safety goal decision criteria '

describcd here do not address issues that deal only with containment performance. Consequently, issues which 3M \'Minvet %is ,

have no impact on core damage frequency (delta CDF of If the safety goal evaluation of the proposed regulatory ,

7ero) cannot be addressed with the safety goal decision action results in a favorable determination (i.e., any deci-criteria. Ilowever, because mitigative initiatives have sion except "no action"), the analyst may presume that been relatively few and infrequent compared with acci- the substantial additional protection standard of 10 CFR dent preventive initiatives, mitigative initiatives will be 50.109 is achievable. The initiative should then be as-assessed on a case-by-case basis with regard to the safety sessed in accordance with Section 4.3, " Estimation and goals. Given the very few proposed regulatory initiatives Evaluation of Values and Impacts" of these Guidelines.

that involve mitigation, from a practical perspective, this Should the impacts not be justified, further activitics and should have little overall impact on the usefulness of the analyses should be terminated unless there is a strong safety goal decision criteria. qualitative justification for proceeding further.

f f

I 11 NUR EGillR-0058, Rev. 2

4 ELEMENTS OF A REGULATORY ANALYSIS This section discusses the specific elements to be inct uded it is the intent of these G uidelines to ensure uniformity in in a regulatory analysis document. These elements in- the scope of or elements to be included in a regulatory clude: analysis. The appropriate level of detail to be included in a regulatory analysis can vary, depending on the particular e A statement of the problem and NRC objectives for circumstances. Factors that the staff should consider in the proposed regulatory action. determining the appropriate level of detail include:

• The complexity and policy significance of the par-e Identification and preliminary analysis of alternative ticular problem being addressed approaches to the problem.

• De magnitude and likelihood of values and impacts e Estimation and evaluation of the values and impacts for selected alternatives, including consideration of e The relative amount by which projected values ex-the uncertainties affecting the estimates. cced impactsM e The immediacy of the need for a regulatory action e The conclusions of the value/ impact analysis and, and time constraints imposed by legislation or court when appropriate, the safety goal evaluation. decisions e The decision rationale for selection of the proposed e Any supplemental direction provided by the Com-regulatory action. mission, the Office of the Executive Director for Operations, or an NRC Office Director.

• A tentative implementation schedule for the pro. He emphasis in implementing the Guidelinem auld be posed regulatory action.

on simplicity, flexibility, and common sense, in terms of the type ofinformation supplied and in the level of detail A regulatory analysis should address each of these ele- provided. The level of treatment given to a particular ments and should also include an executive summary, a issue in a regulatory analysis should reflect how crucial list of acronyms, and identification of the references used. that issue is to the bottom line recommendation of the More detailed guidance for the prepa.ation of regulatory regulatory analysis. In all cases, regulatory analyses must analysis documents is available in the Handbook. The be sufficiently clear and contain sufficient detail to enable Handbook includes methodological tools and generic es- NRC decision makers and other interested parties to timates for the quantification of selected attributes that easily recognize:

are typically included in the NRC value/ impact analyses, as well as an extensive bibliography.

• The problem within the context of the existing regu-latory framework Regulatory analyses are reviewed within the NRC ang

• The proposed regulatory action made publicly available. Reviewers include NRC techm-cal staff and management and formal groups such as the e The conclusions reached and the associated bases Committee to Review Generic Requirements (CRGR),

the Advisory Committec on Reactor Safeguards (ACRS), o The specific data and analytical methods used and and the , Advisory Committee on Nuclear Waste the logic followed that led to the conclusion that the (ACNW). Reviewers typically focus on the appropriate- proposed action was appropriate and justified ness of assumptions, the selection and climination of al-ternatives, estimation techniques, evaluation methods, e The sources and magnitude of uncertainties that any limitations in the data used, and the decision ration. might affect the conclusions and the proposed ac-ale. To facilitate this review, as well as review outside the tion NRC, the staff should carefully document both the as-e The sensitivity of the conclusions to changes in un-sumptions made and the sources of information used in derlymg assumptions and considerations.

preparing the regulatory analysis. Information obtained from outside the NRC, including any from parties inter-ested in a proposed regulatory action, may be used in the " Proposed actions with values and impacts that are estimated to differ preparation of the regulatory analysis after the staff has by a relatively sman amount should normally be anal d in greater been assured of the reasonableness of such information. NI" *'"" ""**#""" ### 7 * '" ""

NUREG/BR-0058, Rev. 2 12

, _ ~_

1 1

4.1 Statement of the Problem and

• The extent (if any)to which the immediate problem l Objective is p rt of alarger problem.

• The relationship of the problem to other ongoing

'Ihe statement of the problem should be a concise sum-studies or actions. (Note: It is important th3 action mary of the problems or concerns that need to be reme- be reviewed in the context of other regt tatory died, defmed within the context of the existing regulatory requirements that apply to the same problem, seh framework. The statement should provide the reader as NRC's prioritized generic safety issues with a clear understanding of exactly what the problem is (NUREG-0933)(Ref.10) or other identified safety and why it exists, the extent of the problem and where it issues meriting NRC's attention,)

exists, and why it requires action. In this context, a meas-ure of its safety importance needs to be presented on

• The objectives of the prbposed action and the rela-either a qualitative or quantitative basis.The focus of this tionship of the objectives to NRC's legislative man-section is to clearly demonstrate that the problem re. dates, safety goals for the operation of nuclear quires action and to demonstrate the implications of tak. p wer plants, and policy and planning guidance ing no action. (e.g., NRC's Five-Year Plan).

For certain regulatory issues there may be existing regula-

• Identification of any existing or proposed NRC (or Agreement State) regulatory actions that address tory requirements or guidance, m. dustry programs, or vol-the problem and their estimated effectiveness.

untary efforts directed at the same or similar problem.

'lliese activities, and any variations in industry practice

• Constraints or other cumulative impacts that work and commitments among licensees, must be identified against solutions to the problem.

and discussed. The need for regulatory action must be justified within the context of what would prevail if the

• Draft papers or other underlying staff documents ,

proposed action were not adopted; this justification re. supporting the requirements or staff positions.

quires assumptions as to whether, and to what degree, voluntary practices may change in the future. In general, 4.1.2 Ilackfit Rule Concerns the no action alternative or base case is central to the estimation ofincremental values and impacts. Additional . r pmNems or concerns within the scope of the backfit discussion is presented in Section 4.3.

rule (10 CFR 50.109), the type of backfit needs to bc identified. Depending on whether the action is bemg tmtt-The problem statement should identify the specific class ated for adequate protection or compliance and not as a or classes of hcensees. reactors, or other facilities affect ed safety enhancement, a regulatory analysis may not be by the problem, as appropriate. Any distinctions between needed or its scope or focus could be markedly different impacted licensees (e.g., NRC and Agreement Statc. (see Section 2.3). Thus, it is important for the preparer of BWR and PWR) should be noted, as well as any differ- the regulatory analysts to address this issue early m the >

ences in facility type, age, design, or other relevant con. regulatory analysis process. For any single acuon, more siderations. than one type of backfit may be involved. Under these circumstances, plants should be assessed for each type of A background discussion of the problem should be in, backfit on a case-by-case basis.

cluded.The background discussion should cover, as appli-cabic: 4.2 Identification and Preliminary Analysis of Alternative Approaches 4.1.1 Ilackground of the Problem Once the need for action has been identified, it'e regula-o A brief history of the problem and the outcome of tory analysis should focus on identifying reasonable alter-past efforts (if any) to alleviate it. natives that have a high hkelihood of resolving the prob-lems and concerns and meeting the objectives identified e Any legislat on or litigation" that directly or indi-under Section 4.1.1.The mitiallist of alternatives should rectly addresses the problem.

be identified and analyzed as carly in the analysis process as possible. For certain rulemakings, an options paper may be needed to identify and delineate substantive is-sucs and to facilitate early consensus on the resolution of l those issues. This analysis forces early consideration and "1Jtigation records could come from court cases.,decmons by an documentation of alternatives and identifies an initially Atonne Safety and licensing or Appeal lhurd, or Lomnussion dect-sions in cases under htigation. preferred option.

13 NUREG/IIR-0058, Rev. 2

The list of alternatives should be reasonably comprehen- scribe to the licensec how the objective or result is to be sive to ensure that the range of all potentially reasonable attained. In other words, requirements should be per-and practical approaches to the prob!cm are considered. formance-based, and highly prescriptive rules and req-The no-action alternative will normally serve as the base uirements should be avoided absent good cause to the case for analysis. In essence, it functions as a default contrary.

approach that will occur if none of the action alternatives is justified. Its primary value is to establish the baseline After the initial list of alternatives isidentified, a prelimi-condition from which all incremental values and impacts nary analysis of the feasibility, valucs, and impacts of each can be calculated. Alternatives generally focus on or ex. alternative usually climinates some alternative ap-plore alternatives to a series of hypothetical questions: proaches. The elimination of alternatives from further What, who, how, and when. analysis can be based on such factors as (1) clearly exorbi-tant impacts in relation to values, (2) technological im-When applicable in defining alternatives, consideration practicality, or (3) severe implementation difficulties. As should be given to the following issues: information is generated as part of the preliminary analy-sis of alternatives, the initial set of alternatives should be e What action shcald be taken?-It may be appropri. refined. For each alternative that survives the preliminary -

ate to identify alternative ways to resolve the prob- screening, a general description of the activities required lem. Viable alternatives could be based on variabil. of licensees and the NRC to implement the alternative ity in the physical and technical requirements should be provided.12 In certain circumstances, this pre-needed to address the problem'at hand. Alternatives liminary screening of alternatives may climinate most of could also include vatying the scope of requirements the alternatives under consideration. In such cases, the and number of licensees affected. subsequent value/ impact assessment need only address the limited set of alternatives that remains.

• Whose responsibility should it be to take ac-tion?-Different entitics may be capable, and there. The alternatives section of the regulatory analysis docu-fore, could assume responsibility for resolving the ment should list all significant alternatives considered by problem. For example, initiatives by licensees and the staff. A brief explanation of the reason for climination industry support groups may constitute a viable al- should be included for alternatives not selected for fur-ternative to some NRC initiative. ther study.

• How should it be done?-The various mechanisms (e.g., generic ! citer, rule, policy statement) available 4.3 Estimation and Evaluation of to the NRC to accomphsh the change should be VaIUCS and ImpaC(S considered.

The alternatives that survive the screening process of e When should it become effective?- Alternative im. Section 4.2 should be analyzed in the section of the regu-plementation schedules and compliance dates may latory analysis document covering the estimation and be appropriate. evaluation of values and impacts. The level of detail need not be equivalent for all alternatives. For example, less The selection of alternatives for any given regulatory detail is needed when one alternative can be shown to be analysis will largely depend on the specific circumstances clearly superior to the others. Nevertheless, this section at hand. For some regulatory analyses, alternatives cover- will often be the longest and most complex portion of the ing the full range of considerations may be appropriate. document. For the purpose of these Guidelines, the fol-For others, circumstances may dictate that the alterna. lowing definitions are adopted:

tives be confined to only one of the categories identified above. For example, Congressional or court rulings could Values The public values that NRC is directed to seek prescribe an NRC action with such specificity that the by Congress (e.g., The Atomic Energy Act of only alternatives open to the NRC are implementation 1954 as amended), as interpreted by the Fed-mechanisms. eral courts and the NRC Office of the General Counsel, are as follows: (1) protection of the If the objective or intended result of a proposed generic public health and safety, including protection requirement or staff position can be achieved by setting a f w rkers m the licensed nuclear m, dustry, readily quantifiable standard that has an unambiguous relationship to a readily measurable quantity and is en- " Inclusion of this information will satisfy the rebuirements of 10 CFR 50.109(e x2)8 for proposed seneric backfits. NR Management '" Direc.

forceable, the proposed requirement should merely spec- $gf[y;;$kftheNIENanheII)'f$rfrs; [a"t1oNt ify the objective or result to be attained rather than pre- ject to CRGR review.

NUREG/HR-0058, Rev. 2 14 e

l l

against the hazards of radiation, (2) protection should be provided. The definition of the baseline case I of offsite property (i.e., property not owned or requires specific attention to ensure against double l leased by a licensee), (3) assurance of the com- counting of either the values or impacts in the regulatoly l l mon defense and security, and (4) upholding analysis. For exampic, in evaluating a new requirement

! and supporting the laws and agreements of the for existing plants, the staff should assume that all existing l United States, including antitrust and environ- NRC and Agreement State requirements and written l mental laws and international agreements. licensee commitments have been implemented, and con-sequently the values and impacts associated with these Impacts The consequences of a proposed regulatory ac- requirements and commitments are not part of the incre-tion that are not values. mental values or impacts associated with the regulatory action under consideration. Similarly, insofar as new The staff should consult the llandbook and any relevant regulatory requirements may affect future plants, the NRC reports or documents issued subsequently for addi- reference point for these plants should also be the exist-tional guidance on estimating and evaluating values and ing regulatory requirements. To ensure against double ,

impacts. General principles to be followed are discussed counting of either the values or impacts in the regulatory #

in this section. analysis, the staff should be aware of values and impacts  ;

associated with other formally proposed regulatory ac- t Categories of groups affected by the proposed regulator 7 tions related to the subject action that are likely to bc I action should be identified. Groups may include (but are implemented. I not limited to) the general public, units of State and local i government, licensecs, employees of licensecs, contrac. The NRC encourages voluntary actions that enhance ,

tors and vendors, and the NRC. Within each affected safety, and when such actions are being implemented on j group further differentiation, i.e., licensec suppliers or an industry-wide basis with no evident safety problem, t contractors, may be necessary if the proposed action af- great weight and due consideration should be given to j fccts segments of the group differently. Under these cir- these initiatives before imposing requirements to codify  ;

cumstances, separate estimates and evaluations of values them in the regulations. However, when voluntary initia- l' and impacts should he made for cach distinct category. tives are in place over only a portion of the industry, or The categorization of licensees may be appropriate for a when they achicyc only part of the safety objectives asso-variety of reasons. For example, the effects of a new ciated with a regulatory change under consideration, it requirement can be markedly different between newer may be necessary to codify the practice. The handling of .!

facilitics that have had safety features installed during these voluntary practices has important implications on construction and older facilities, the baseline case and consequently on the quantification  ;

, ofincremental values and impacts. For the purpose of the ,

For each affected group, the attributes that characterize regulatory analysis, with certain exceptions noted below, }

the consequences of the proposed action should be iden- no credit should be given for the voluntary actions taken f lified. The G uidelines and Handbook should be reviewed by licensecs. This means that when calculating the values  ;

before selecting appropriate attributes. For each identi- and impacts of a proposed regulatory requirement and its fied attribute, values and impacts are to be estimated on a alternatives, the consequences should not be reduced by net basis.9 the extent to which they may already be lessened by vol- ,

untary activities. Impacts already incurred by licensees or  !

Value and impact estimates are to be incremental best applicants in conjunction with these voluntary actions can  ;

estimates relative to the baseline case, which is normally be excluded from the incremental impact estimates if they j the no-action alterr.ative." When possible, best esti- are irreversible, i.e., if cost recovery is not possible. l mates should be made in terms of the "mean" or "ex- 1 pected value." However, . depending upon the level of Most voluntary actions are discretionary, and their im-detail available from the data sources employed in the pacts are primarily on- going and future-oriented. Such  !

value/ impact analysis, acceptabic estimates could include programs might be characterized as adopting very vague  ;

other point estimates such as the median. However, the requirements, lacking in NRC enforceability, and result- i rationale for use of estimates other than mean values ing in nonuniform programs across all licensees. It is the l NRC's intent to be able to impose regulatory require- l ments in lieu of voluntary programs that, for any number t "Both value and impact attributes may have postive or negative as- of reasons, are not providing the level of safety assurance I

}

Ei$nNnYe7rcI$r"N"c2tS[aNcYnNNNo"b"ug deemed necessary by the NRC. This would be the case, l tionaland public exposure may decrease because of a reduced risk of for example, when voluntary programs are nonuniform l

"" " de"'

across all licensecs; as a result, some licensees may not l "Procedmes formaking bcst estimates are discuned in the llandbook. have such programs or established programs could casily 15 NURliG/BR-0058, Rev. 2

I I

i dissipate by licensee action alone, perhaps without NRC's Estimated values and impacts will generally be expressed knowledge. Furthermore, if credit is provided for volun- in monetary terms whenever possible and expressed in tary initiatives and values and impacts associated with the constant dollars from the most recent year for which price ,

proposed regulatory action are reduced, meaningful adjustment data are available. Consequences that cannot I health and safety improvements could not be assumed in be expressed in monetary terms should be described and I the future because they would remain uncodified and quantified in appropriate units to the extent possible. In voluntary in nature, not subject to enforcement on the this regard, it is recognized that many regulatory actions, part of the NRC. When the base-case value/ impact re- such as those affecting non-power reactor and materials s sults take no credit for voluntary actions, a sensitivity licensees, may not be supported by available PRA analysis  !

analysis should be performed and the value/ impact re- and that for some actions, probabilistic analysis tech-  !

sults displayed with credit for voluntary actions. niques may not be practical. However, the staff needs to i make every effort to apply alternative tools that can pro- ,

vide a quantitative perspective and useful trends concern-In general,if the NRC could ensure with high or reason- {

able assurance that the voluntary program would con- ing the value of the proposed action. Even inexact quanti-tinue and effectively accomplish its objectives, the values fication with large uncertainties is preferable to no and impacts attributable to the regulatory initiative quantification provided the uncertaintics are appropri- ,

should be reduced accordingly. For example, voluntary atch condderci actions that are a part of an overall industry commitment' The staff should use care to verify that neither values nor  !'

with appropriate follow-up evaluations, would be subject impacts are double counted. Values and impacts that are to special treatment on a case-by-case basis. In addition' '

determined to be unquantifiable should be identified and y credit should be given for a voluntary action when its discussed qualitatively. An attribute should not be omit-dominant impacts have already been incurred, such as the -

t ed from a regulatory analysis document simply because it addition of a capital-intensive safety system, because is determined to be unquantifiable. '

ihere is little financial incentive to climinate it. Similarly, a voluntary program that involves a written commitment  ;

or one that affords the NRC some degree of enfor- 4.3.1 Estimation of Values ceability is not easily abandoned. Relevant value attributes should be identified and as-sessed for each alternative. These assessments should j Uncertaintics are an important element to consider in the reflect best estimates, preferably mean values, which l development of a regulatory analysis. The sources and would account for(Cfferences m the likelihood and effec-  !

magnitudes of uncertainties in value and impact estimates tiveness of each alternative's ability to solve the problem.  !

and the methods used to quantify uncertainty estimates To the extent applicable, possible value attributes to be should be discussed in all regulatory analyses. Hypotheti- assessed include changes in (1) pubhc radiation exposure cal best and worst case values and impacts can be esti- health risk, (2) projected offsite damage to property or mated for sensitivity analyses. Sensitivity analysis can be the environment, (3) occupational radiation exposure used in addition to or in lieu of formal uncertainty analv- health risk, (4) antitrust practices, (5) safeguards nsks,

~

i sis, the former option being exercised when uncertainty and (6) mitigation of environmental damage. Changes in I

analysis is impractical or exceedingly complicated and public health and safety from radiation exposure and off-costly. Additional information on incorporating uncer- site property impacts should be examined over a 50-mile taintics and sensitivities in a regulatory analysis is in the distance from the plant site. Care must be taken to ensure

~

Handbook. The 1landbook also discusses the distinction that the change m risk accounts for potential changes m between them. plant or operational complexity, including the relation-ship to proposed and existing regulatory requirements.

All changes in risk to the public and to workers should be Values and impacts should be estimated by year and for estimated and discussed. When appropriate, health risks the entire time period that groups will be affected by the should be estimated for both routine operations and acci-proposed regulatory action. For licensed facilitics, esti- dents.

mates should be made for the remainder of the operating license or projected useful life of the facility. For power Changes to any of these value attributes may be either reactors, separate estimates for a license renewal term positive or negativet any individual attribute may have should be made if the analyst judges that the results of the both positive and negative components. For example, a regulatory analysis could be sigmficantly affected by the requirement for new equipment within areas where ra-

inclusion of such a renewal term. If not, the basis for the diation is present will result in increased occupational judgment or conclusion that there would not be a signifi- cxposure during installation of the equipment. However, j c:mt effect should be stated for future reference. this requirement may reduce occupational exposure dur-NUREG/llR-0058, Rev. 2 16

l- ing routinc operation and in the event of an accident. All be developed. The level of effort in terms of model devel-these positive and negative components in exposure must opment and data collection is dictated by the same factors be considered in deriving a net value for occupational that are utilized by the staffin determining the lcvel of exposure and a net change in occupational exposure. detail for the overall regulatory analysis (see Section 4).

'Ihe ability to assess the risk can vary dramatically de- The third level or type of regulatory analysis involves pending on the data and information available that is regulatory initiatives that for one rcason or another can- j i

directly pertinent to the particular regulatory action un- not be quantified with meaningful limits on uncertainty.

der consideration. Generally, the extent of any support. Certain power reactor issues, such as those involving ing detailed information will allow one of three types of emergency preparedness, security, and personnel req-regulatory analyscs to be developed: uirements, tend to fall into this category. In these in- ,

stances, the analyst must provide a qualitative basis and a (1) Detailed PRA or statistics-based analyses are avail. clear description of how the regulatory action isjustified. i able or can be developed to support the quantifica- The analyst is cautioned that this type of value/ impact tion of values (benefits). assessment is subject to a higher level of scrutiny by the decision maker because of the need to ensure that addi- *

.(2) Some factual information or data are available that tional burdens on licensees are justified. Reliance on the can provide a quantitative perspective but may in-qualitative approach should be a last resort, to be used volve considerable extrapolation of data; thus, the only after efforts to develop pertinent data or factual resulting analysis may be quite uncertain and lack information have proven unsuccessful. '

completeness or precision.

4.3.2 Estimation of Impacts (3) Extremely few data or accepted models exist to sup-port a quantitative type analysis; as a result, the The number of potential impact attributes is very large.

analysis must be qualitative. Once this situation is ,'

What constitutes an appropriate impact is highly depend-understood and the nature or type of the analysis is ent on the specific circurnstances of the alternative under i determined, the analyst should proceed as outlined consideration. To the extent applicable, impacts to be >

below. For a more detailed discussion, including ex-assessed include:

amples of actual assessments, the analyst is referred .

t to the Ilandbook.

• Direct costs or savings to licensees Typically, the most detailed and specific value assessment

• Costs or savings to the NRC wdl involve regulatory initiatives impacting nuclear i power reactors for which PRA analyses can be applied.

• Costs or savings to State and local government agen-The PRA can be used to generate a fairly detailed and cies ,

comprehensive quantification of the expected risk reduc-tion expressed in changes in core melt frequency or in

• Nonradiation risk-related costs or savings to the gen-person-rem averted. This value is then quantified in dol. cral pubbe lars based on a dollar per person-rem conversion factor.  !

}rhe next level of quantification supporting regulatory

• minatives concerns situations in which PRAs are not Changes in regulatory efficiency or scientific knowl- ,

available and other data and analyses must be used to edge needed for regulatory purposes justify the anticipated regulatory burden. Although no e unique formula or algorithm can be postulated, the gen- Conformance with formal positions adopted by na-tional and international standards organizations.

erally recommended approach is to utilize whatever data .

may be available within a simplified model to provide Impact estimates should be included for incremental im-some quantitative perspective or insight on the nature pacts associated with each alternative. When applicable, and absolute or relative magnitude of the risk, as well as the estimation of impacts should include information on any discernable trends in the data. Typically, this ap- i both installation and continuing costs, including the cost proach will generate results that are subject to significant of facility downtime or the cost of construction delay, levels of uncertainty. The uncertainties will, in turn, re- Sunk costs may be identified, but should not be included quire explicit disclosure of the simplifying assumptions embedded in the model as well as the data limitations. *The Comminion handirected the staff to tical avorird on site rmtsas Typically, a sensitivity analysis t hat shows t he variability in "" [ 'y % ' [ N y % Cy'lj" N Q j "*n $ " N the derived risk as a function of key assum;,tions should ence 12.

i 17 NUREG/BR-0058, Rev. 2

)

4.

i in the evalua' tion of impacts or the presentation of the cause it indirectly attaches a value on human life. Various results of the evaluation. Impacts should be estimated - methodological approaches provide varying degrecs of from society's perspective. Transfer payments such as justification for a wide range of dollar per person-rem ,

insurance payments and taxes should not be included as values. A review and analysis of this issue is ongoing, and impacts, in addition, depreciation is an accounting con. the $1000 value is to be used pending completien of the cept that should not be included as an impact. current reassessment. This reassessment may also ad-dress a periodic inflationary adjustment.

The analysis of impacts also has to be sensitive to the true '

impact (cost) ta licensees. For example, the practice of In other than severe power reactor accident applications, alhicating no replacement energy costs by claiming tLt alternative values to the $1000 per person-rem may be the requirement can be accomplished during a regularly considered and evaluated.There may be a range of appli-scheduled outage is not always practical or reasonable. In cable values based on willingness-to-pay analyses, occu- ,

reality the cumulative effect of all new requirements cim pational exposure surveys, health consequence models l such as HECOM, adjustments for inflation and alterna-adJ incremental downtime, and therefore analysts should attribute appropriate replacement energy cost penalties tive fatality coefficients, and other case-specific data, as i to their respective regulatory actions if practical. Further, available. The Handbook contains a discussion of these for new requirements that ha'.c extremely high imple. estimating methodologies as well as representative val- ,

mentation costs or that will greatly increase operating ucs. If alternative valucs arc explored, dollar valucs appli- ,

costs, the analyst needs to consider the possibility that the cable to the situation should be discussed and the value/ l imposition of such impacts may result in some facilitics no impact results clearly displayed for the decision maker in longer being economic and thus having to terminate op. order to show the sensitivitics of the proposed action to erations. this consideration. ,

1 To provide meaningful summations, a present-worth ba-Evaluation of Values and Impacts 4.3.3 sis is normally used for evah,ating all values and impacts. '

Applying present-worth techniques to health and safety The evaluation of quantified estimates of the values and consequ ences has been controversial because it suggests a 3 impacts associated with a proposed regulatory action in- discounting of benefits" and the implication that a lower I volving NRC licensecs generally mvolves expressing val- value is being placed on future lives and illnesses. How-ucs and impacts on a common basis, i.e., constant dollars ever, the principle for regulatory analysis is that future from a reference year. health effects should be valued the same as current ef-  :

i fccts and present-worth techniques achieve this. For ex- 1 Since the values and impacts need to be estimated for the ample, based on the current conversion factor, health and entire time period that members of society will be af- safety consequences are to be consistently valued at fected by the proposed regulatory action, a present-worth $1000 per person-remJrhus, a person-rem averted in the basis is normally used to allow meaningful summations yea- 1995 or 2010 or 2050 will be assigned a value of $ 1000 and comparisons. This approach provides a rational basis (in constant dollars). The present-worth calculation is

for evaluating health and safety effects as well as the simply determining how much society would need to in-associated impacts, yet this approach has a numher of vest today to ensure that $1000 is available in a given year complexities and controversics. n the future to avert a person-rem. By using present-worth, health and safety effects, i.e., person-rem, regard-In order to place all values and impacts on a common less of when averted in time, are valued equally, basis, it is necessary to have a conversion or coefficient reflecting the monetary worth of a unit of radiation expo- Hased on OMB guidance, all values and impacts should sure. In accordance with past NRC practice, unless other- be expressed on a present-worth basis using the recom-wise justified, $1000 per person-rem in 1993 dollars is to mended discount rate specified in the latest version of serve as the dollar conversion factor for all offsite conse- OMB Circular A-94.This circular was most recently up-quences (health-related impacts and dollar values for off- dated on November 10,1992,(Ref.13) and specifies the sit e cleanup. contamination, and property damage values) use of a 7 percent real (i.e., adjusted to climinate the of severe power reactor accidents. The same dollar con- effect of expected inflation) discount rate. OMB's 7 per-version factor will serve as a reference point or baseline cer t rate approximates the marginal pre-tax real rate of when offsite consequences are not involved, such as for return on an average investment in the private sector in occupational exposure, non-power reactor accidents, nnd recent years.

A1. ARA determinations associated with cleanup of :en-taminated sites. It should be noted that the dollar evalu- An alternative analysis using a 3 percent real discount ation of radiation exposure is a highly sensitive issue be- rate should also be prepared for sensitivity analysis pur-NUREG/HR-0058, Rev. 2 IS

i poses. The base case, using for example OMH's currently 4.4 Presentationi of Results recommended 7 percent rate, reflects recent economic conditions, yet NRC actions typically involve a 30- to F, r each alternative considered, a net value calculation 60-year time horizon. Given that uncertainties expand as Summ don of positive and negative attributes), as pre-one attempts to project further into the future, it is con-

. scribed by OMB (Ref. 6), should be computed and dis-sidered prudent to examine the result of assuming a lower played.The net value calculation requiree, to the extent rate as part of a sensitivity analysis. There are also theo-possible, that all values and impacts be quantified in pre-retical argumentsin the economicsliterature that support '

sent worth monetary terms and added together (with the the use of lower rates (Ref.14). A 3 percent rate is appropriate algebraic signs) to obtain the net value in proposed for the alternative case because it approximates dollars. In addition, the analyst may choose to display the the long-term nsk-free real rate of return on mvestment results based on the ratio of values to impacts. This based on historical data. If the alternative rate does not method of display is supplemental, however, and not a alter the bottom-line result, simply indicating this conclu- replacement for the net value method. Under the ratio sion is sufficient. If there is a different conclusion or if the method, the numerator reflects the sum of all quantifi- -

value/ impact determination is significantly altered. this able present worth estimates classified as values, while result should be discussed and placed in perspective for the denominator does likewise for impacts. Considerable the decision maker. are is required in calculating the ratio because statistical bias and differing results can occur depending on the calculational approach employed. Although both presen-tation procedures may be used to clarify the results, the  ;

For certain regulatory actions, such as those involving decommissioning and waste disposalissues, the value/im- ".et value method is generally preferred because at pro- >

vides an absolute measure of the aggregate net effect of pact analysis may have to consider consequences that can the proposed action. Sclecting the alternative with the occur over hundreds or even thousands of years.1 or the largest net value is consistent with obtaining the largest  :

reasons listed above, and based on the techmcal litera-societal gain from among the alternatives analyzed. The ture, extended time horizons bring into question the ap-ratio, on the other hand, is a relative measure, particularly propriateness of using a relatively high interest rate for useful for prioritizing a large collection of proposed ac- t present-worth calculations. When the timeframe exceeds tions in the presence of a cost constramt Under a cost 100 years, the analyst should avoid the use of a 7 percent constraint, independent actions are optimally selected by realinterest rate. In these instances, the NRC regulatory the largest ratios, continuing to add actions in descendino analysis should display results to the decision maker in order, until the cost constraint is obtained. The Advisory i two ways. First. on a present. worth basis using a 3 percent Committee on Reactor Safeguards endorsed the view I real rate, and second, by displaying the values and impacts that the net value and ratio measures should both be a l at the time in which they are incurred with no present- part of the decision process (Ref.15). OMB maintains l worth conversion. In the latter case, no calculation of the I that the regulatory analysis should select the regulatory rerutting net value or value/ impact ratio should be made. alternative that achieves the greatest net benefit, and that the ratio has characteristics that make its results poten-tially misleading (Ref. 6):

Finally, as a general principle, sensitivity or uncertainty I analysis, or both, should be performed whenever the val. "Beaefit-cost ratios, if used at all, must be used with care ues of key attributes can range widely. A sensitivity analy. to avoid a common pitfall. It is a mistake to choose among i sis would consider the effect of varying the values of the mutually exclusive alternatives by selecting the alterna-attributes one at a time to measure each attribute's effect tive with the highest ratio of benefits to costs. An alterna-upon the overall result. Uncertainty analysis typically live with a lower benefit-cost ratio than anoiher may have l would require computer simulations, while sensitivity the higher net benefits." /Ref. 6) analysis could be performed in an analytic manner.

Should the sensitivity or uncertainty analysis indicate that Tabular and graphic displays of results and associated the preference among alternatives depends significtmtly uncertainties should be included if their use will facilitate on the variation in one or more key attributes, additional comparison of alternatives. The values and impacts W investigation to reduce this dependence may be appropri- attributes that are quantified in other than monetary

] ate. The extent to which sensitivity or uncertainty analy- terms should be displayed in a manner that facilitates ses are performed should rcDect the magnitude and like- comparison of alternatives. Values and impacts not quan-

lihood of values and impacts and their associated tified in the regulatory analysis should be discussed and variability, compared among alternatives.

19 NURl!G/BR-0058. Rev. 2

l For alternatives projected to result in significantly differ- tains the basis for concluding that the following condi-ent values and impacts for different categories of licen- tions will be satisfied.

sees, separate evaluations of values and impacts should be made for each such disiinct category. In addition, if e The public health and safety and the common de-significant differences exist between recipients of values fense and security would continue to be adequately and those who incur impacts, the distribution of values protected if the proposed reduction in requirements and impacts on various groups should be presented and or positions were implemented discussed.

• He cost savings attributed to the action would be substantial enough to justify taking the action, and For certain proposed regulatory actions, the value/ impact the savings would clearly out-weigh any reduction in analysis may consist of only a cost effectiveness analysis. benefits.

For cumple. the NRC may be required to initiate a requirement and achieve a certain level of value based on In general, actions that would relax or reduce require-court or Congressional mandates, or NRC may require ments should give licensees the option of whether to take compliance or adequate protection actions. Under these advantage of the change and should not be mandatory. .

circumstances, the issue is not to determine whether the flowever, calculation of the cost savings should be based impacts of the new requirement are justified, but rather on the assumption that all licensees will take advantage of to ensure that the requirement achieves the necessary the change. This is consistent with the NRC's position on level of value in an efficient and cost effective manner voluntary practices as described in Section 43.

given the other implementing mechanisms availabic.

Sim;larly, there may be proposed actions with important values th,1 cannot be assigned monetary values or with U I)ecision Rationale for Selection of uncertainties that are substantial. If the alternativcsyield the Proposed Action similar values, cost effectiveness analysis can be used to choose the most efficient alternative. This section of the regulatory analysis should explam why 1 the proposed action is recommended over the otheralter-natives considered. Taking no action should be consid-The effect of each alternative on other NRC programs cred an alternative except when the action has been man-and requirements should be discussed. Effects on pro- dated by legislation or a court decision. The decision grams of other Federal agencies er agencies of State and criteria for the selection of the proposed action should be local governments should also be discussed. The extent to identified. The critcria should include (but are not neces-which the effects are discussed should be in proportion to sarily limited to):

their significance.

• The net value and value/ impact computations For those proposed regulatory actions subject to a safety e The relative importance of attributes that are quan-goal evaluation (see Section 3), the results of 1 hat analysis tified in other than monetary terms should appear in this section of the regulatory analysis. A satisfactory finding relative to the proposed safety goal e The relative importance of nonquantifiabic attrib-decision criteria is considered a prerequisite for achieving utes the substantial additional protection critcria of the backfit standard in 10 CFR 50.109. Proposed actions subject to e The relationship and consistency of the proposed the backfit rule (enept for backfits falling within the alternatives with the NRC's legislative mandates, three exception categories of 10 CFR 50.109(a)(4)(see safety goals, and policy and planning guidance that Section 23)), are also required to show that the direct and are in effect at the time the proposed alternative is indirect costs of implementation are commensurate with recommended the substantial increase in safety. A c!carly positive find-ing with respect to the net value or value/ impact ratio e The impact of the proposed action on existing or would normally satisfy this standard. planned NRC programs and requirements.

This section of the regulatory analysis document should For proposed regulatory actions that would rchix or re- also include:

duce current requirements, the backfit rule and the rafety goal evaluation process and decision critcria contained in e A statement of the preposed g:meric requirement or Section 3 are not applicable. However, for relaxations, staff position as it is proposed to be sent out to supponing documentation should be prepared that con. licensees NUREG/HR-0058, Rev. 2 20

o A statement of the sponsoring office's position as to ments awaiting implementation should be included. An whether the proposed action would increase or relax assessment of whether implementation of existing req-(or reducc) existing requirements or staff positions uirements should be deferred as a result and any other information that may be considered appropriate with re-o A statement on whether the proposed action is in- gard to priority, schedule, or cumulative impact should be terim or final, and if interim, the justification for included.The schedule should be rcalistic and allow suffi-imposing the proposed backfit on an mterim basis.

cient time for such factors as needed analyses, approvals, procurement, installation and testing. training, and re-4.6 Implementation sources needed by licensees to implement other NRC and Agreement State requirements. Regulatory analyses are The regulatory analysis should identify how and when the required to identify related regulatory and industry ac-proposed action is to be implemented. The proposed tions, even though it may be very difficult to properly NRC instrument for implementing Ihe proposed action characterize and account for all actions. Although regula-should be identified (e.g., rule, regulatory guide) and the tory actions generally are to be implemented in a timely reasons for selecting the proposed instrument discussed. manner, implementation schedules should be sufficiently A specific date for implementation should also be identi- flexible to minimize the cumulative burdens imposed on ficd and discussed. licensees by multiple regulatory requirements. When ap-propriate, alternative schedules should be prepared.

A schedule should be prepared showing the steps needed NRC staff actions as well as actions that will be needed by to implement the proposed action. The action should be others (e.g., Agreement States and licensecs) should be prioritized and scheduled in view of other ongoing regula- identified. In this regard, thi.; section should describe the tory activities affecting the facilities, if possible, a sum- magnitude and availability of NRC resources to facilitate mary of the current backlog of existing related require- implementation of the proposed action.

l l

l l

I

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21 NURIiG/IIR-0058, Rev. 2

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T 5 RELATIONSHIP TO OTHER PROCEDURAL REQUIREMENTS This section discusses the relationship of the develop- ing, processing and using the information, but not by ment of a regulatory analysis to certain statutory proce- shifting disproportionate costs or burdens onto the pub-dural requirements applicable to the NRC and to infor- lic. Agencies should consult with interested agencies and mation requests directed to licensees. The Paperwork members of the public in an effort to minimize the burden Reduction (Section 5.1) and Regulatory Flexibility (Sec- of the information collection to the public. OMB clear.

tion 5.2) Statements are typically included as appendices ance packages are to identify any significant burdens to the Regulatory Analysis and they are documented here placed on a substantial number of small businesses or for completeness. The other information requests and entities (5 CFR 1320.11(a)).

procedural requests (Sections 5.3 thru 5.5) typically con-sider issues similar to the regulatory analysis, and conse- In the event that the OMB disapproves an information quently, the Guidelines can provide useful guidance in collection, independent regulatory agencies such as the their development as well. NRC may override the disapproval or stay of effective-ness of approval of a collection ofinformation by a major- -

ity vote of the Commissioners (5 CFR 1320.20). Proced-5.1 Paperwork Reduction Act ures for Commission override of an OMB eisapproval are contained in NRC Management Directive 3.54, "Collec-The Paperwork Reduction Act (Public law 96-511) con- tions of Information and Reports Management" (for-tains procedural requirements designed to minimize and merly NRC Manual Chapter 0230).

control the burdens associated with collections of infor-mation by Federal agencies from individuals, businesses and other private entities, and State and local govern. 5.2 Regulatory Flex.bility i Act ments. The NRC's internal procedures for complying with the Paperwork Reduction Act and preparing justifi. The Regulatory Flexibility Act (Public Law 96-354) re-cations for OMB approval of information collections are quires Federal agencies to prepare a regulatory flexibility contained in NRC Management Directive 3.54, "Collec. analysis if a proposed rule will have a significant economic tions of Infonnation and Reports Management," (Ref. impact on a substantial number of small entities. '1k 16). analysis is to describe the impact of the proposed rule on small entities (5 U.S.C. 603). On December 9,1985, the Whenever a proposed regulatory action identified under NRC adopted size standards it would use to determine

~

Section 4.5 of these Guidelines will likely involve infor- whether an NRC licensee would be considered a small mation collections subject to OMB approval, a draft entity for the purpose of implementing requirements of OMB clearance package is to be included as a stand-alone the Regulatory Flexibility Act (Ref.17). On November 6, appendix to the regulatory analysis. 1991, the NRC published a general notice that restated its size standards to clearly identify the different classes of licensees affected and the standard that is applied to each Agencies are required to obtain OM B approval for collec-class of licensee (Ref.18). Specifically, the NRC added tions ofinformation under any of the followmg conditions the Regulatory Flexibility Act's definition of small gov-(5 CFR 1320.4(a),1320.7(c)): (1) the mformation collec-ernmental jurisdiction adopted by the NRC but not in-tion involves 10 or more persons by means of identical cluded in the 1985 notice announcing the adoption of the questions or reporting or recordkeeping requirements' size standards. The size standards used by the NRC to (2) the mformation collection is contained in a rule of qualify a licensee as a small entity are as follows:

general applicability, (3) the collection is addressed to all or a substantial majority of an industry, even if that major-

• A small business is a business with annual receipts of ny mvolves fewer than 10 persons.

53.5 million or less, except private practice physi-cians, for which the standard is annual receipts of $1 OMB's criteria for approval of information collections million or less.

are contained in 5 CFR 1320.4(b)and (c).To obtain OMB approval for information collections, an agency must

• A small organization is a not-for-profit organization demonstrate that the collection ofinformation: (1)is the that is independently owned and operated and has least burdensome necessary for the proper performance annual receipts of $3.5 million or less.

os the agency's functions,(2)is not duplicative ofinforma-tion otherwise available to the agency, and (3) has practi-

• Small governmental jurisdictions are governments cal utility.The agency should minimize its cost of collect- of cities, counties, towns, townships, villages, school NUREG/BR-0058, Rev. 2 22 m

1 l

districts, or special districts with a population ofless than 50,000.

5.4 Information Requests Under 10 CFR 50.54(f) o A small educational institution is one that (1) is Proecdures for NRC information requestr directed to supported by a qualifying small governmental juris- production and utilization facility licensees ppear at 10 diction or (2)is not State or publicly supported and CFR 50.54(f). The regulation requires NRC to prepare a has 500 or fewer emph>yces.

written statement justify;ng the reasons for the informa-tion reques'. except when the information is needed to NRC has established procedural requirements for prepa- verifylicensee compliance with the current licensing basis ration of regulatory flexibdity analyses. These require- for the facility. The written statement is to establish that ments are presented in tbc *NRC Regulations lland- the burden imposed on the licensee is justified in view of book," NUREG/BR-0053 (Ref.19). If a proposed rule is the poter ';al safety sigmficance of the issue. All justifica-likely to have a significtmt economic impact on a substan- tion statunents must be approved by the cognizant Office tial number of small entities, a draft regulatory flexibility Director or Regional Administrator before issuance of analysis must be prepared consistent with the NRC pro- the information request.

cedural requirements. The regulatory flexibility analysis is normally included as an appendix to the regulatory Section IV(B)(xi) of the CRGR Charter (Ref. 7)contains analysis document and as an insert to the proposed rule. additional guiAnce for information requests affecting

'Ihe regulatory flexibility analysis need not repeat infor- multiple plants.The CRGR Charter specifies that when a mation discussed in the body of the regulatory analysis; written justification is required, the written statement is such information may be referenced. If the NRC eleter- to include:

mines that the proposed rule would not have a signiicant economic impact on a substantial number of small cnti- e A problem statement that describes the need for the ties. the NRC is required to include a certification to this information in terms of the potential safety benefit effect in the proposed rule. The regulatory analysis must contain sufficiert information concerning the potential e The licensee actions required and the estimated cost impact of the proposed rule on small entities to support to develop a response to the information request this certification.

• An anticipated schedule for NRC use of the infor-mation 5.3 National Environmental Policy Act

• A statement affirming that the request does not

'lhe National Environmental Policy Act (NEPA) requires Federal agencies to prepare an environmental impact Written statements prepared according to the preceding statement (EIS) for major Federal actions significantly requirements tojustify information requests are not regu-affecting the quality of the human enviromnent [42 latory analyses within the scope of these Guidelines.Nev-U.S.C. 4332(2)(C)]. NRC's procedures for implementing ertheless, the written justification will have many of the NEPA are at 10 CFR Part 51 and the "NRC Regulations elements of a regulatory analysis.The elements of a regu-I landbook," NUREG /B R-0053, contains preparatory in- latory analysis discussed in Section 4 can appropriately be formation. When a generic or programmatic EIS has been included in an information request justification. An infor-prepared that forms the basis for the proposed regulatory mation request justification will normally be a more con-action, a brief summary of the EIS will be an acceptable cise document than a regulatory analysis.

substitute for the information and analysis requirements identified in Sections 4.1-4.3 of these Guidelines. The __

EIS may be referenced at other appropriate points in the 3.3 Supportm.g Analys.is for regulatory analysis document to avoid duplicating existing Compliance and Adequate written material. Protection When a regulatory analysis and an EIS or erwironmental As documented in 10 CFR 50.109 and in NUREG-1409 assessment (EA)are beihg prepared for a proposed regu- (Ref. 9), a regulatory action does not require a backfit latory action, preparation of the two documents should be analysis if the resultmg safety benefit is required for pur-coordinated as much as possible. For example, the alter- poses of compliance or adequate protection under 10 natives examined in the regulatory analysis should corre- CFR 50.109(a)(4). In these cases of exceptions to the spond as much as possible to the alternatives examined in backfit standard and analysis, a documented evaluation the EIS or EA. should be prepared, including a statement of the objec-23 NURliG/BR-0058, Rev. 2

tives of and the reasons for the action along with the basis may change to reflect new information pertinent to for invoking the exception. Guidance is provided in 10 whether improvements are needed to ensure adequate C17R 50.109(a)(6) and the Supplementary Information Protection.

portions of the Federal Register Notices for the final If immediately effective regulatory action is needed, the backfit rule (Refs. 20 and 21). In this connection, the required documented evaluation for cither compliance or concept of what constitutes adequate protection is deter- adequate protection may follow the issuance of the regu-rnined case by case. It is expected that this determination latory action.

NURl!G/BR-0058, Rev. 2 24 H

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REFERENCES

1. IIxecutive Office of the President," Federal Regula- 13. Office of Management and Budget, "llenefit-Cost l tion," Executive Order 12291, Federal Register, Vol. Analysis of Federal Programs; Guidelines and Dis-46, No. 32, February 19,1981, pp.13193- 13198. counts " Circular No. A-94, FederalRegister, Vol. 57, i November 10,1992,pp.53519-53528.  ;

2. U. S. Nuclear Regulatory Commission "A Hand- ,

book for Value. Impact Assessment," NUREG/ 14. O. II. Paananen and P. L Hendrickson, Pacific i CR-3568 (PNie4646), December 1980. '

Northwest Laboratories, " Selection of a Discount

. . Rate for Use in Regulhtory Analyses Prepared by

3. U. S. Nuclear Regulatory Commission, " Regulatory the U. S. Nuclear Regulatory Commission and Ap-Analysis Guidelines of the U.S. Nuc! car Regulatory plication of Discount Rates to Future Averted Commission," NUREG/HR-0058, Revision 1, May licalth Affects," letter report to U. S. Nuclear l 1984.  ;

Regulatory Commission, January 1993.

4. U. S. Nuclear Regulatory Commission, " Policy Statement on Safety Goals for the Operation of 15 P. Shewmon, Advisory Committee on Reactor Safe-Nuclear Power Plants," Tcdcral Register, Vol. 51, p. guards, letter to J. M. Taylor, U.S. Nucicar Regula- ,

30028, August 21,1986. tory Commission,

Subject:

Revised Regulatory l Analysis Guidelines, November 12,1992.

5. Administrative Council of the United States,

" Agency Procedures for Performing Regulatory 16. U. S. Nuclear Regulatcry Commission, " Collections  !

Analysis of Rules," (Recommendation No. 85-2,1 of Information and Reports Management," Man- i CFR 305.85-2) and " Valuation of fluman Life in agement Directive 3.54, July 1989. -

Regulatory Decisionmaking" (Recommendation  ;

No. 88-7,1 CFR 305.88-71 '

17. U. S. Nucicar Regulatory Commission, " Adoption  !

6. Office of Management and Budget," Regulatory Im- of Size Standards,"FederalRegister, Vol. 50, Decem-pact Analysis Guidance," Appendix V in Regulatory ber 9,1985, pp. 50241-50242.  ;

Program of the United States Government: April 1.

1990-March 31,1991.

18. U. S. Nuc! car Regulatory Commission, "Clarifica-tion of Size Standards " Federal Register, Vol. 56,  :

'7. J.M. Taylor, Executae Director for Operations, U. November 6,1991, p. 56671.  !

S. Nuclear Regulatory Commission, memorandum 1 to Office Directors, " Revised Charter-Committec  !

to Review Generic Requirements," April 18,1991. 19. U. S. Nuclear Regulatory Commission "NRC Regu-lations Handbook," NUREG/HR-0053, Rev. 2, De.

8. U. S. Nuclear Regulatory Commission, "NRC Pro. cember 1989.

gram for Management of Plant. Specific Backfitting of Nuclear Power Plants," Management Directive 20. U. S. Nucicar Regulatory Commission, " Revision of ,

8.4, August 1988. Backfitting Process for Power Reactors," Federal  !

Register, Vol. 50, September 20,1985, pp. 38097-

9. U. S. Nuclear Regulatory Commission,"Backfitting 38113.

Guidelines," NUREG-1409 July 1990.

10. U. S. Nuclear Regulatory Commission, "A Priorit . 21. U. S. Nuclear Regulatory Commission," Revision of l zation of Generic Safetylssues," NUREG-0933 and Hackfitting Process for Power Reactors-Final Supplements, August 1992. Rule," Federal Register, Vol. 53, June 6,1988, pp.

20603-20611. l

11. U. S. Nuclear Regulatory Commission, Staff Re-quirements Memorandum, "SECY-89-102-Im- Copics are available for inspection or copying for a fee plementation of the Safety Goals" June 15,1990. from the NRC Public Document Room at 2120 L Street NW., Washington, DC: the PDR's mailing

12. W. C. Parler, General Counsel, U.S. Nuclear Regu- address is Mail Stop L1r6, Washington, DC latory Commission, memorandum to Commissioner 20555-0001; phone (202) 634-3273; fax (202)

F. Bernthal, June 4,1987. 634-3343.

25 N UR EG /HR-0058, Rev. 2

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