ML20138C320

Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission

ML20138C320
Person / Time
Issue date:	05/31/1984
From:	NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
References
NUREG-BR-0058, NUREG-BR-0058-R01, NUREG-BR-58, NUREG-BR-58-R1, NUDOCS 9704300090
Download: ML20138C320 (27)

Text

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Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission Office of the Exocutivo Director for Operations OkN L

May 1984

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UNITED STATES NUCLEAR REGULATORY COMMISSION g WASHINGTON. D. C. 20655 r.

\ April 30,1984 HEMORANDUM FOR: Office Directors and Regional Administrators FROM: William J. Dircks Executive Director for Operations

SUBJECT:

ISSUE OF REVISED REGULATORY ANALYSIS GUIDELINES (NUREG/BR-0058) TO INCORPORf.TE REFERENCE TO A HANDBOOK FOR VALUE/ IMPACT ASSESSMENT (NUREG/CR-3568)

In January 1983, the NRC published a set of Regulatory Analysis Guidelines, NUREG/BR-0058, for application on all proposed and final rules submitted for review by the Comittee to review Generic Requirements or for decision by the Executive Director for Operations or the Comission. These guidelines estab-lish a flexible framework for analyzing alternative regulatory actions and contain instructions and describe information needed to support a regulatory analysis.

To assure that all rulemaking actions and other NRC requirements and guidance are supported by a sufficient regulatory analysis, an evaluation of the action being proposed is to be prepared in accordance with the criteria set forth in Section Ill.B of the guidelines. The analysis, as a minimum, must include an assessment of the value and impact of the proposed action.

In December 1983, the NRC published a Handbook for performing Value/ Impact As-sessments,NUREG/CR-3568. The objective of the Handbook is to provide a set of systematic procedures for performing value/ impact assessments consistent with HUREG/BR-0058 and the Charter of the Comittee to Review Generic Requirements.

Use of the procedures and methods described in the. Handbook should provide a coherent, understandable, well-documented account of the basis for NRC regu-latory actions. Consistent with the Regulatory Analysis Guidelines, the methods described in the Handbook are flexible and several options are presented for setting the appropriate level of effort to be comitted to a given value/ impact assessment. A principal benefit associated with use of the Handbook is a consistent, disciplined approach for perfonning value/ impact analyses which clearly displays all of the important values and impacts (and their uncertainties) associated with a proposed regulatory change in a suc-cinct, organized and clearly understandable form.

This allows decisionmakers, and other interested parties, to easily determine:

(1) the conclusions reached, (2) the bases for conclusions, (3) the type, mag-nitude and source of uncertainties which might affect the conclusions. (4) the e

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2 sensitivity of any conclusion to variations in the important input parameters af fecting the conclusions, and (5) the analytical methods used and the logic which led the analyst to the conclusions presented.

While it is recognized that the procedures in the Handbook are in an evolu-tionary process, it is likely that extensions and refinements to the procedures and methods can best be identified as experience is gained from their use, further, competence in developing and presenting meaningful value/ impact analy-ses can be enhanced by use of this guidance. Therefore, to take full advantage of the Value/ Impact llandbook, as it currently exists. I have revised the Regu-latory Analysis Guidelines (Sec. III.B.4.a) to incorporate NUREG/CR-3568 by reference as the reconmended guideline when preparing value/irpact analyses.

This guidance should be used throughout your offices for purposes addressed by NUREG/BR-0058, which includes analyses to be considered by the CRGR.

WilliaFJ. Dircks Executive Director for Operations

Enclosures:

As stated CC: 4 Chairman P.alladino Conmissinner Gilinsky Commissioner Roberts Conmissioner Asselstine Commi5sioner Ocrnthal SECY OPC OPE PDR i

\ UNITED STATES NUCLE AR REGULATORY COMMISSION n

&  ! WASHINGTON. O. C. 30886

\..... December 13. 1982 MEPORANDUM FOR: Office Directors and, Regional Administrators FROM: William J. Dircks Executive Director for Operations

SUBJECT:

ADOPTION OF REGULATORY ANALYSIS GUIDELINES TO REPLACE VALUE IMPACT GUIDELINES On December 7,1981, I appointed an interoffice task group to review the Comission's guidelines for performing value impact analyses and to reccmend changes that would improve their use and quality. The revised guic;elines, Regulatory Analysis Guidelines, are enclosed; A regulatory analysis, prepared pursuant to these guidelines, must accompany all proposed rules and final rules to which the guidelines apply which are submitted for review by the Committee to Review Generic Requirements and the Deputy Executive Director for Regional Operations and Generic Requirements and for decision by the Executive Director for Operations and the Commissioners.

The guidelines provide for a structured, but general framework for analyzing alternative regulatory actions. They provide instructions for completing tasks necessary for a sound regulatory analysis. They also provide the flexibility to tailor the depth and length of an analysis to the significance of the regulatory action being considered. The procedures also provide for the incorporation of analyses of information collections required by the Paperwork Reduction Act and analyses of impacts on small ehtities required by the Regulatory Flexibility Act. A checklist approach is recommended for the use by the staff in identifying effects of alternative regulatory actions on other NRC programs, licensee operations, and other activities. A sample checklist is enclosed with the guidelines as well as a list of effects that. illustrate consequences that could result in a cost or benefit.

To assure that other rulemaking actions and non-rulemaking generic require-ments are also supported by a sufficient analysis, an evaluation of the action being proposed that addresses the topics set forth in Section Ill.B of the guidelines must be prepared. The evaluation at a minimum must include an assessment of the costs and benefits of the proposed action compared to the existing situation, but need not be es extensive or detailed as required for rules which fall within the coverage of the guidelines. The evaluation

shall acconpany all rulemaking actions which do not meet the threshold criteria for performing a regulatory analysis and other generic requirements that are submitted for review to the Comittee to Review Generic Requirement or to the Deputy Executive Director for Regional Operations and Generic Requirements, or for decision by the Executive Directnr for Operations or the Comission.

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'l William J. Dircks Executive Director for Operations

Enclosures:

As Stated cc: Chairman Palladino Comissioner Gilinsky Comissioner Ahearne Comissioner Roberts Comissioner Asselstine.

SECY OGC OPE POR l

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REGULATORY ANALYSIS GUIDELINES OF THE UNITED STATES NUCLEAR REGULATORY COMISSION

TABLE OF CONTENTS fa21 I. Purpose ..................'...................................... 1 II. Coverage ....................................................... 1 III. Instructions for Preparing a Regulatory Analysis ............... 2 A. Instructions for Preparing a Regulatory Analysis .......... 2

1. Introduction ......................................... 2

2. Scope of the Analysis ................................ 2

3. Consideration of Alternatives ........................ 3

4. Analyses Required by Statute ......................... 3

5. Relationship to the Generic Environmental Impact Statement ............................................ 3

8. Contents and Format for the Regulatory Analysis ........... 3

1. Statement of the Problas ............................. 3

2. Objectives ........................................... 4

3. Alternatives ......................................... 4

4. Consequences ......................................... 4

a. Costs and Benefits of Alternatives .............. 4

b. Impact on Other Requirements .................... 5

c. Constraints ..................................... 5

5. Decision Rationale ................................... 5

6. Implementation ....................................... 5

a. Schedule for Implementing the Proposed Action ... 5

b. Re;ationship to Other Existing or Proposed Requirements .................................... 6 Appendices:

Appendix A - Analyses Required to Justify the Imposition of an Information Collection Requirement .................... A-1 Appendix B - Analyses Required When a Substantial Number of Smal,1 Entities will be Impacted ............................. B-1 Appendix C - Checklist for Identifying Potential Impacts on NRC Programs, Licensee Operations and Other Activities .... C-1 Appendix 0 - Examples of Effects that Could Result in a Cost or Benefit ................................................ D-1 i

REGULATORY ANALYS!$ GUIDELINES I

PURPOSE The principal purpose of these Reaulatory Analysis Guidelines,is to ensure that the NRC regulatory decisions are based on adequate.information concerning the need for and cnnsequences of a proposed regulatory action and to ensure that cost effective regulatory actions, consistent with providing the necessary pro-taction of the public health and safety and common defense and security, are identified. High quality regulatory anclyses should serve as the basis for NRC decisions. Therefore, a regulatory analysis must be included in all decisien '

packages on matters covered by these guidelines.

11 COVERAGE A. A Regulatory Analysis, which includes a discussion of any reasonable alternatives to the proposed action, shall be prepared for each proposed rule and final rule that, in the determination of the responsible office director or the Executive Director for Operations, will likely result in the following:

a. An annual effect on the economy 5f $100,000,000 or more in direct - '

and indirect costs, or

b. A significant impact on health, safety or the environment, or

c. A substantial increase in the cost to NRC licensees, permit holders or applicants, to Federal, state or local governnients, and geographical regions, or

• B. A Regulatory Analysis shall also be prepared for other rules and generic requirements not covered above when directed by the Commission or the Executive Director for Operations.

"The ED0 has directed that other rulemaking actions not covered by the manda-tory review categories above and non-rulemaking generic requirements submitted for review or approval by the Committee to Review Generic Requirements, the Deputy Executive Director for Regional Operations and Generic Requirements, the EDO or the Commission should also be supported by an analysis based on the guidance provided in Part III.B of the Guidelines but much less detail is required.

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c III GUIDELINES FOR PREPARING A REGULATORY ANALYSIS A. Instructions for Preparino a Reculatory Analysis

1. Introduction The following guidelines are designed to provide a framework for structuring.

the analysts required to support proposed and final generic regulatory require-ments. The analysis is intended to aid the staff and the Commission.in deter-mining whether to initiate a regulatory action, in selecting the preferred regulatory aU ernative, and in providing a coherent, understandable, and well-documented explanation of why a particular action was recommended.

. Making the performance of a regulatory analysis an integral part of developing a staff position on a proposed regulatory action, not as an afterthought simply to meet a procedural requirement, a better and more efficiently prepared analysis should result. Also use of the procedures to outline the scope of the analysis ,

could significa.ui/ aid in determining the level of effort and associated I resources required to perform a regulatory analysis as well as contributing to i the early identification of potential alternatives, possible consequences and information that may be needed to perform the analysis. l A regulatory analysis should accompany all proposed rules and final rules which are covered by these guidelines which are forwarded for review by the Committee to Review Generic Requirements'or the Deputy Executive Directur for Regional Operations and Generic Requirements, or submitted for decision by the Executive ,

Director for Operations or the Commissioners.

2. - Scope of the Analysis The scope of the regulatory analysis.should primarily be in proportion to the  ;

safety significance of the regulatory action being adiressed. However a rule or generic requirement of small safety significance and large potential costs should be rigorously analyzed. The emphasis in implementation of the procedures should be on simplicity, flexibility, and common sense, both in terms of the l type of information supplied and in the level of detail provided. Since the )

principal purpose of the procedures is to assure that the proposed action has been sufficiently analyzed and the rationale for its selection well documented, staff efforts should be primarily dedicated to achieving this purpose rather j than spend bg yreat effort rigorously analyzing an alternative when-it has j become cpparent that the alternative will not be acceptable. However, the )

written narrative should-indicate the rationale for rejecting any alternative that was seriously considerad even though the effort required to reach the .

decision was limited. 1

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3. Consideration of Alternatives A Regulatory Analysis prepared for a proposed rule or final rule covered by Section II.A of these guidelines should include a discussion of any reasonable alternatives to the proposed action. Alternatives considered should be confined tc major alternative regulatory approaches rather than to relatively minor vari-attons of the proposed action. Among alternatives that could be considered are taking no action at all, making mo u effective use of existing enforcement mechanisms, establishing performance standards and deregulation when appropriate.

The extent to which costs and benefits should be antessed for alternatives is to be determined by the responsible office director.

4. Analyses Required by Statute Information collection requirements (application, reporting and recordkeeping) ..

affecting ten or more persons or organizations must be approved by the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act. Instruc-tions for addressing factors needed to obtain the OMB's approval are contained in Appendix A. These factors must be addressed in the regulatory analysis when the alternative regulatory actions involve information collections.

Where a rulemaking action is likely to have a significar' impact on a substantial number of small topties, the Regulatory Flexibility Act requires that the impact be addressed spet.i n cally. Appendix B provides guidance on the factors that must be addressed when evaluating cecnomic impacts on small entities.

5. Relationship to the Generic Environmental Impact Statement l

In those circumstances whe.re a Generic Environmental Impact Statement (GEIS) has been prepared and forms the basis for the proposed action, a brief summary of the GEIS will be an acceptable substitute for Sections III.B.1,2,3,4 of the regulatory ,1ysis guidelines which address the problem, objectives, alterna-tives, and consequences, respectively. Staff will have to provide an explanation of the rationale int selecting the proposed action and rejecting other alterna-tives considered in the GEIS (Section III.B.5), and describe the implementation schedule and relationship of the proposed action to other requirements and progran : (Section III.B.6).

B. Contints and Format of the Regulatory Analysis

1. Statement of the Problem Explain the nature of the problem that will be addressed by sne proposed regula-tory requirement and why any action is necessary at this time. Identify the class or classes of licensees, reactors or ot%r facilities affected by the prot lem. Discuss any applicable existing or proposed NRC regulatory actions that currently address the problem, their achievements and costs, and sig-nificance of taking no action to address the problem.

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2. Objectives

,qu ' a u Within the general objectives of protecting the public health and safety sad the common defense and security of identifying cost-effective alternatives, precisely state the specific objectives that the proposed regulatory action is designed to achieve. ,

3. Alternatives Identify objectives.

ulatory any reasonable alternatives considered for achieving the specific reg-

4. Consequences Provide factors: an analysis of each alternative considered that discusses the following

a. Costs and Benefits of Alternatives.

For proposed rules and final rules above the thresholds set forth in Sec-tion 11 the regulatory analysis should describe the benefits and the posts, including any cumulative effects, that may result from the imple-mentation of the proposed requirement or any reasonable alternative that was considered. Examples of the types of effects that could result in a cost or benefit are listed in Appendix D. The analysis should also iden-tify the classes of persons or organizations who will receive the bens-fits, or incur the costs from the proposed alternatives. These could in-clude licensees, vendors, licensee suppliers or contractors, the NRC staff, Federal, State or local governme,nts or small business establish-ments and other small entities. Any effects on geographical regions should also be identified, f The sources of cost data and methodologies for deriving costs and benefits should be identified and referenced. NUREC/CR-3568, A Handbook for Value Impact Assessment, provides acceptable methods for conducting cost / benefit analyses. Every attempt should be made to quantify the costs and benefits that may result from a particular alternative, even if uncertainties in the data prevent a precisely accurate numerical estimate. Where it is not possible to quantify costs and benefits, the reason should be indicated; and the analyst should describe the nature and extent of the costs or benefits in as precise and succinct a manner as possible. All assumptions and uncertainties underlying the data and methodologies should be stated.

Where possible, costs and benefits should be expressed in safety, occupa-tional exposure or monetary. terms. Monetary costs and benefits should be expressed in present value through the use of an annual discount rate of ten parcent (10%). However, other. discount rates may be used to test the sensitivity of the analysis. All benefits and costs which are expressed in monetary terma should be convertad to constant dollars (i.e., dollars should not be adjusted to reflect anticipated inflation).

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5 The cost of complying with the proposed requirement or part of the pro-posed requirement through the use of a Regulatory Guide or other meanc deemed acceptable by the NRC should be specifically identified.

b. Impacts on Other Requirements The effect of an alternativf. a all other NRC programs and requirements, as well as those of other pa arnment entities and licensees, should be considered. Any associated s osts or benefits should be indicated. The extent to which these effects are addressed should be.in proportion to the significance of thelt impact on the other programs. Comnean sense should be used to avoid such considerations becoming a major study effort.

To assist the staf f in Identifying impacts on oth* r requirements or programs, use of a checklist such as the one described in Appendix C is recommended.

c. Constraints Identify any constraints that affect the implementation of the alterna- '

tive, including scheduling, enforceability, policy, institutional, or legal considerations.

5. Decision Rationale Explain why, in light of the analyses performed, the proposed action is recom-mended and why other alternatives coraidered were rejected. Identify and reference the data or studies on which the decision is based, including ANSI or ASHE standards, staf f papers or other documents. Identify any decision criteria used. Also, it should be indicated if the proposed action represents the staff's definitive position on the subject, or if the requirement is the first or part of a series of related requirements to be issued.

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6. Implementation

a. Schedule for Implementing the Proposed Requirement Describe the steps and schedule, ar altarnative schedules, that will likely be required to implement the proposed requirement. Include in the schedule any staff actions which will be needed, Sufficient information should be provided to demonstrate that the schedule or alternative schedules are ,

realistic. When the proposed action involves short-term and long-term i requirements, those requirements should be stated.

Where one or more classes of reactors or other facilities are affected, it should be demonstrated that sufficient time is provided to make required craputations, allow the licensee, permit holder or applicant to design any needed new systems or modifica*. ions to existing systems, obtain any neede1 NRC approval of designs or changes in technical specifications, test and evaluate designs, procure equipment and labor, install equipment, i develop operating procedures and train operators. Plant conditions which ]

are necessary for installing equipment, conducting preoperational tests A

.gj and operable tests should be described. The length of time a plant must be shut down to meet the proposed requirements should be indicated. Also indicate whether any required new equipment is available in sufficient quantity to meet the needs of all affected Itcensees or whether it must be designed.

b. Relationship to Other Existing or proposed Requirements Indicate the relationship of the proposed action to other existing or pro-posed requirements, its effect on priorities for implementing other requirements for related activities, and if the proposed action means that other actions or systems or prior analyses need to be reassessed, a v

APPENDIX A Analysis Required to Support, the Imposition of Information Collection Requirements The Paperwork Reduction Act (P.L.96-511) requires agencies to obtain a clearance from the Office of Management and Budget (OMB) for all information collection requirements (applications, reporting, recordkeeping) that af fect 10 or more persons. The analysis required for OMB clearance must consider the necessity for the proposed information collection, its practical utility, the economic and time burden placed on the person subject to the requirement, and its cost to the federal government. All regulatory actions proposed by the staff that involve information collections, whether mandatory or =voluntary, must be accompanied by an OMB Supporting Statement that justifie. and describes the requ;rement. The regulatory analysis may constitute the supporting state-ment. The following factors must be addressed in any regulatory analysis involving an action which imposes an information collection requirement.

1. Justification

a. Need for The Information Collection Explain why the information collection is needed (i.e., describe any problems that justify the need for the requirement and explain how it is the best means of achieving the regulatory objective),

b. Practical Utility of the Information Collection Explain to whom the information is to be reported and for what purpose it will be used. Decribe the NRC's capability to use the reported information in a timely and useful fashion. Explain the purpose for requiring respondents to maintain information not required to be submitted to NRC.

c. Cuplication With Other Collections of Information If the requirement duplicates or overlaps other informstion collec-tions made by the NRC or other government agencies, identify those information collections and explain why that information cannot meet the need being addressed.

d. Consultations Outside the NRC Describe any consultations with other Federal, stato or local govern-ment agencies or with other organizations or individuals regarding the information collection.

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e. Other Supportino Information Discuss any other information which may help in understanding and evaluating the need for and use of the information collection requirement.

2. Description of the Information Collection

a. Number and Type of Respondents Identify the number and type of respondents t which the information collection requirement applies annually.

b.

Reasonableness of the Schedule for Collectina Information Describe the schedole for imposing the information collection require-ment and explain why it is reasonable within the context of the need for the information,

c. Method of Collecting the Information l

Discuss alternative methods, if any, for collecting the information.

If alternatives are available, explain why the information collection requirement selected is the least burdensome method for achieving the regulatory objective, and is consistent with sound management practices.

Examples of less. burdensome methods include verification and review of a record at the licensee site rather than submission of a report, submission of reports or retention of records in micro-form rather than in paper copy transmission of reports through use of automated word processing or, computer means rather than by paper cr microform, reduction in the number of copios distributed, simpli-fication.of format, accepting a similar report containing the same information, consoitdation of two or more reports into a single report, or conducting interviews or telephone surveys of a sample segment of the licensees affected,

d. Record Retention Period

• Identify the record retention period and explain why it is necessary.

Provide justification where records are required to be retained for more than four years,

e. Reporting Period Identify the frequency with which the report must be submitted to the NRC or other organizations. If the report is required to be submitted more of ten than quarterly, the need for this more frequent reporting should be specifically described.

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f. Copies Required to be Submitted Identify.the number.of copies to be submitted, their distribution and usage. Provide justification where more than three (3) copies are required'to be submitted.

3. Estimate of Burden

a. Estimated Hours Required to Respond to the Collection Indicate how much time (staff hours) the respondent will spend annually if it is a recurring or multi year requirement to comply with the information collection requirement.

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b. Estimated Cost Required to Respond to the Collection

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Indicate how much it will cost (dollars) the respondent annually to comply with the information collection requirement.

c. Source of Burden Data and Method for Estimatino Burden Indicate the suurces from which burden estimates were obtained and the method used to estimate the burden.

d. Reasonableness of Burden Estimates Explain why the burden estimates are reasonable.

4. Estimate of the Cost to the Federal Government Describe the annual cost of the information collection to the Costs include NRC time and in terms of staff time and administrative expense.

resources required to obtain, process and store the information, such as "the cost of information collection design development, tests, printing forms, malling list compilation and maintenance, editing, coding,' tabula-tion anal'yses and publication. If contractors are involved in the1informa-tion collection, then their cost should be included."

Commission procedures for implementation of the Paperwork Reduction Act require each office, through its Information Management Coordinator, to submit the Supporting Statement to the Office of Administration for review before it is submitted to OM8 for approval. Further information on procedures related to the Act will be published in NRC Manual Chapter 0230 " Federal Reports Management."

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i APPENDIX 8 Analyses Required When a Substantial Number of Small Entities Will Be Impacted The Regulatory Flexibility Act (P.L.96-534) requires an analysis of any pro-posed rule, or final rule that is preceded by a proposed rule, which is likely to have a significant economic impact on a substantial number of "small entities" (small business establishments, non-profit organizations, and small government jurisdictions). The analysis must indicate the criteria used to identify'the small entities (annual receipts for sales or service, number of employees, etc.)

. and explain how the regulatory action will affect the small entity. The analyst must determine whether a significant number of the small entities affected are likely to experience substantial economic consequences including additional burdens associated with information collection requirements as a result of the proposed rulemaking action. It must also include consideration of alternatives which could accomplish.the objective of the proposed regulation while minimizing the economic impact on small entities.

In cases where a proposed rule will not have a significant economic impact on a substantial number of small entities, a " regulatory flexibility certification" to this effect must be included in the Federal Register Notice. It should be noted that the Regulatory Flexibility Act applies only to rulemaking actions.

All the information required for purposes of the Regulatory Flexibility Act should be contained in the analysis prepared pursuant to the Regulatory Analysis Procedures and a separate analysis need not be prepared. For more information on the Act and its requirements, see " Guidance for Implementing the Regulatory Flexibility Act and the Preparation of Regulatory Flexibility Analyses," dated April 1, 1981 (Division of Rules and Records, Office of Administration).

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APPENDIX C Checklist for Identifying Potential Impacts on ~NRC Programs, Licensee Operations and Other Activities Alternative:

Analyst:

Date:

Instructions:

This sample checklist is designed to aid the analyst in identifying the impacts of each alternative regula-tory action on other NRC programs, licensee operaticas and other activities. It is not intended to be all inclusive. Rather, it is intended to serve as a guide for the analyst who may develop a more comprehensive checklist that would apply to the particular program area. The analyst should indicate whether each alter-native being considered will affect (1) NRC programs and requirements, (2) licensee programs and operations, _

(3) interagency or intergovernmental agreements between NRC and other agencies, (4) .U.S. international..,

agreements and commitments, and/or (5) other analyse's required by. law. .The staff responsible for a specific...

activity should be consulted if the analyst cannot independently determine if an impact on the activity would result. Each area or program identified as being affected- should be evaluated and addressed in the regula ,. ,

tory analysis. .

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C-2 Checklist A. MRC Programs and Requirements and Licensee Operations

1. Indicate the areas cr programs which may be affected by each alternative regulatory action being considered for each of the categories listed below:

HRC programs and requirements Licensee implementation

• Licensing Facilities Facilities actions Inspection / in early in late . . ,

NRC under enforcement Operating construction construction regulations ** review program facilities stage stage (a) Reactors ..-

1. Reactor construction, for example:

a. Seismology

b. Weiding

c. Concrete

d. Fire protection

e. Other (specify) ii. Reactor operations, for exansple:

a. Control room

b. Safety checks / tests A

Licensee programs and operation.

mm Proposed or existing regulations or any implementing guidance such as Regulatory Guides, or NUREGs.

4 C-3 Licensee implementation NRC programs and requirements Facilities Facilities Licensing in early in late actions Inspection / constructica enforcement Operating construction NRC under facilities stage stage regulations review program

c. Human factors _

d. Fire protection _

e. Other (specify) iii. Emergency preparedness iv. Vendor reactor designs . ._

v. Protecting workers from radiation vi. Protecting members of public in unrestricted areas - . -_

vii. Protecting the environment viii. Safeguards physical security .. .-

ix. Licensee personnel access screening program

x. Safeguards infor-mation security program (b) Fuel Facilities and Materials

1. Protecting workers from radiation

11. Protecting members of public in unrestricted areas _

C-4 NRC programs and requirements Licensee implementation Licensing Facilities Facilities actions Inspection / in-early in late i NRC under enforcement Operating construction construction I regulations review program facilities staga stage iii. Protecting the environment iv. Emergency preparedness

v. Safeguards material control and account- '~ ~~

ability vi. S,afeguards physi' cal security * -

vii. iicenseepersonnel .

acce.ss screening -

program -

viii. Safeguards informa-tion security program ix. Transportation - ' - -

safety and security ~-

(c) Waste management, _ _ . . . .

for example: -

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1. Waste management site construction -

a. Seismology

b. Hydrology -

c.

Geology

d. Other

C-5 NRC programs and requirements Licensee implementation Licensing Facilities Facilities actions Inspection / in early in late NRC under enforcement Operating construction construction.

regulations review program facilities stage stage 1

11. Site operations etc.

a. Public health

b. Environmental considerations iii. Closure, decommission-ing and long-term care, etc. ___

iv. Transportation t ~

2. Indicate whether or not the NRC staff will have difficulty in inspecting or' enforcing the alternative regulatory action being considered. ._

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3. Indicate whether the alternative regulatory action being considered will have an impact on the operational status of the facility ,

4. Indicate if the alternative regulatory action being considered will-have an impact on the NRC:

1. Export / Import Responsibilities

11. Rules of Practice (e.g., 10 CFR Part 2) 111. Other (specify)

B. Licensee Capabilities

1. Indicate whether or not the alternative regulatory action being considered will have an impact on:

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1. The size or quality of the licensee's staff ii. The licensee's ability to:

a. Develop new equipment or designs

b. Acquire contract services l

111. The licensee's program for complying with the requirements of the license?

(e.g., QA tests,' training, reporting)

C. Interagency or Intergovernmental Agreements

-1. Indicate whether or not the alternative regulatory action being considered will.have .

an impact on:

1. The NRC State Agreements Program

a. Licensing of byproduct,' source and small quantities of SNM (specifically~

address changes that may be required of individual states' licensing programs)

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11. Any agreements (MOUs) between UC and other d.S. Agencies (e.g.~,' DOE, YEMA, EPA,~

DOT, DOL,DOJ) -- -

111. Other regulatory programs of Federal and State Agencies D. U.S. International Agreements

1. Indicate whether or not the alternative regulatory action being considered will h' ave an impact on:

.i. Bilateral or multilateral agreements between U.S. and other nations relative to nuclear trade, imports or exports:

11. U.S. agreements with international agencies (e.g., U.S. - United Nations IAEA Safeguards agreement)

E. Applicability of Other Analyses Required by Law

1. Indicate whether or not the alternative being considered will impose an information collection (application, reporting, or recordkeeping) requirement? If applicable, refer to Appendix A.

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2. Indicate whether or not the alternative being considered is likely to have a significant impact on a substantial number of small entities including those which may be licensees, vendors, or suppliers? If applicable, refer to Appendix B.

F. Indicate Impacts Not Referenced in Sections A through E  ;

1. Specify i l

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APPENDIX D Examples of Effects that could Result in a Cost or Benefit

1. RADIOLOGICAL SAFETY CONSEQUENCES (a) Change in accident prcbabilities; specify the accidents (old, new probabilities) -

(b) Change in failure probabilities; describe the equipment directly and indirectly affected by the proposed action (old, new probabilities)

(c) Change in population at risk (percent and absolute) .

(d) Change in occupational exposure; during installation, operation or maintenance (res) '

(e) Change in unplanned radioactive releases offsite (curies)

(f) Change in routine radioactive effluent releases (curies)

(g) Change in operator response times (seconds / minutes)

(h) Change in maintenance capability (yes/no) (explain)

(1) Change in NRC's inspection and enforcement capabilities (yes/no)

2. SAFEGUARDS IMPACTS (a) Change in facility security (yes/no) (explain)

(b) Change in materials control and accountability (yes/no) (explain)

(c) Change in transportation security (yes/no) (explain)

3. OPERATIONAL IMPACTS (a) Change in reactor availability (hours / days)

(b) Change in facility downtime beyond that normally scheduled (hours / days)

(c) Change in allowable reactor rating (percent and absolute) i

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! 4. ECONOMIC IMPACTS l

(a) Construction cost change (dollars)

(b) Operating cost changes (dollars) l (c) Retrofit costs (dollars)

(d) Recordkeeping and reporting cost changes (staff-hour; dollars)

(e) Change in onsite personnel requirements (staff-hours)

(f)

NRC costs change; include contractor technical assistance costs (staff-hours or dollars)

(g) Other increases in applicant expenditures for compliance with regulatory requirements (staff-hours or dollars)

(h) Change in expected direct cost of an accident (dollars)

5. ENVIR000 ENTAL IWACTS (a) Change in water quality (b) Change in air quality

6. INFORMATICM COLLECTION IMPACTS (Resulting from application, reporting or recordke'eping' rlequ (a) Annual licensee / applicant staff hours (hours)

(b) Annual licensee / applicant cost (dollars)

(c) Annual cost to ,the NRC ,(hours / dollars)

7. OTHER IMPACTS (for example)

(a) Consequences for small business (dollars / hours)

(b) Significant impacts on vendors, and equipment suppliers (yes/no)

(c) Anti-competitive consequences (impact on viabiIlty of existing firms to complete or provide equipoent) .

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