Regulatory Guide 10.12

Preparation for Petitions for Rulemaking Under 10 CFR 2.802 and Preparation and Submission of Proposals for Regulatory Guidance Documents.

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Issue date:	12/31/1996
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U.S. NUCLEAR REGULATORY COMMISSION December 1996 REGULATORY GUIDE

OFFICE OF NUCLEAR REGULATORY RESEARCH

REGULATORY GUIDE 10.12 (Draft issued as DG-0010)

PREPARATION OF PETITIONS FOR RULEMAKING UNDER 10 CFR 2.802 AND PREPARATION AND SUBMISSION OF PROPOSALS

FOR REGULATORY GUIDANCE DOCUMENTS

A. INTRODUCTION

processing PRMs, and its intent is to make the rulemak Any interested person may petition the Nuclear ing process more open to licensees and the public.

Regulatory Commission to issue, amend, or rescind This regulatory guide also provides the procedures any regulation. The basic procedure and requirements for submitting proposals to change existing regulatory for submitting a petition for rulemaking (PRM) are set guidance documents.

forth in Section 2.802, "Petition for Rulemaking," of Part 2, "Rules of Practice for Domestic Licensing Pro The information collections contained in this regu ceedings and Issuance of Orders," in Title 10 of the latory guide are covered by requirements that were ap Code of Federal Regulations (10 CFR 2.802). proved by the Office of Management and Budget, ap proval number 3150-0136.

The minimum requirements and other information for submittal of a PRM by interested parties are pro The public reporting burden for persons submit vided in 10 CFR 2.802(c). An individual may consult ting PRMs to the NRC containing information that with the NRC staff before filing a PRM. However, the would allow the NRC to process the PRM in a more ex assistance that may be provided by the NRC staff is lim peditious manner is estimated to average 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> per ited by 10 CFR 2.802(b) to describing the process, ex response, including the time for reviewing instructions, plaining the existing regulations and their basis, and as searching existing data sources, gathering and main sisting the prospective petitioner to clarify a petition. taining the data needed, and completing and reviewing The NRC staff may not draft or develop text or alterna the collection of information. Send comments on any tive approaches for petitioners. aspect of this collection of information, including suggestions for reducing the burden, to the Information This regulatory guide provides guidance to persons and Records Management Branch (T-6 F 33), U.S. Nu who submit PRMs to the NRC concerning the type and clear Regulatory Commission, Washington, DC

quantity of information that would allow the NRC to 20555-0001, or by Internet electronic mail to process the PRM in an expeditious manner. This guide BJS1@NRC.GOV; and to the Desk Officer, Office of delineates factors the NRC uses in setting priorities for Information and Regulatory Affairs, NEOB-10202 USNRC REGULATORY GUIDES The guides are issued in the following ten broad divisions:

Regulatory Guides are issued to describe and make available to the public such informa tion as methods acceptable to the NRC staff for implementing specific parts of the Corn- 1. Power Reactors 6. Products mission's regulations, techniques used by the staff in evaluating specific problems or pos- 2. Research and Test Reactors 7. Transportation tulated accidents, and data needed by the NRC staff in its review of applications for per- 3. Fuels and Materials Facilities 8. Occupational Health mits and licenses. Regulatory guides are not substitutes for regulations, and compliance 4. Environmental end Siting 9 Antitrust and Financial Review with them is not required. Methods and solutions different from those set out in the guides 5. Materials and Plant Protection 1t0 General will be acceptable if they provide a basis for the findings requisite to the issuance or con tinuance of a permit or license. by the Commission.

This guide was issued after consideration of comments received from the public. Corn- Single copies of regulatory guides may be obtained free of charge bywriting the Office of Administration, Attention: Distribution and Mall Services Section, U.S. Nuclear Regulatory ments and suggestions for improvements in these guides are encouraged at all times, and Commission, Washington, DC 20555-0001; or by fax at (301)415-2260.

guides will be revised, as appropriate, to accommodate comments and to reflect new in formation or experience.

Issued guides may also be purchased from the National Technical Information Written comments may be submitted to the Rules Review and Directives Branch, DFIPS, Service on a standing order basis. Details on this service may be obtained by writing NTIS, 5285 Port ADM, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Royal Road, Springfield, VA 22161.

(3150-0136), Office of Management and Budget, change to the level of protection of public health and Washington, DC 20503. safety or of the common defense and security) and are The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information supported by the type of information described in this guide will be given the next priority. 1 unless it displays a currently valid OMB control num PROPOSALS FOR REGULATORY GUIDANCE

ber. The collections associated with this regulatory DOCUMENTS

guide are voluntary. There is also a need to clarify the procedure for sub

B. DISCUSSION

mitting proposals from concerned parties to change ex isting regulatory guidance documents (RGDs). RGDs PETITIONS FOR RULEMAKING include documents such as regulatory guides, bulletins, generic letters, and sections of Standard Review Plans The NRC is developing this guidance to expedite (including branch technical positions). Because these the processing of PRMs by the NRC by encouraging documents do not have the force and effect of regula the submittal of PRMs accompanied by strong techni tions, but serve to identify or clarify methods or posi cal support. The NRC believes that technical support tions acceptable to the NRC staff for compliance with ing information in the depth discussed in this guide NRC regulations, petitioning for a change in a RGD is would effectively expedite the processing of PRMs. If a not normally an effective way to raise a safety concern petitioner follows this guide, the NRC should be able to (unless the petitioner is attempting to point out that a review and process the PRM more expeditiously.

current RGD contains defective guidance that does not In proposing improvements to NRC regulations to comply with the regulation and affects safety).

reduce the regulatory burden, to enhance safety, or for Any party who has a specific concern about the safe other objectives, petitioners are encouraged to provide operation of a nuclear power plant or a nuclear materi supporting information demonstrating that the pro als facility should use the process established in posed changes will result in the desired outcom

e. Peti

10 CFR 2.206, concerning the modification, suspen tioners are also encouraged to use publicly available sion, or revocation of a license, to bring these concerns safety information to support the cost effectiveness of to the attention of the NRC. Likewise, anyone who is the safety enhancements for which they are petitioning.

concerned that an existing NRC regulation does not PRMs are evaluated and scheduled for the NRC's provide adequate protection to public health and safety, review and disposition by considering the merits of the environment, or the common defense and security each PRM. A PRM is judged first by its safety signifi should do the same through the process established in cance and then by the degree of complexity or difficulty 10 CFR 2.802, "Petition for Rulemaking."

of the analysis that the NRC staff must perform to deter The public and the nuclear industry currently par mine the disposition of the petition, that is, whether the ticipate in formulating the final RGDs through the pub petition will be accepted through a rulemaking action lic comment process for new or revised RDGs pro or denied. The degree to which a supporting analysis is posed by the NRC. However, other than for regulatory complete, accurate, and thorough will affect how rapid guides, there is no formal administrative framework for ly the NRC staff is able to make such a determination.

any concerned party to submit proposals recommend Consideration of the safety significance is the first ing changes to existing RGDs. This regulatory guide criterion for reviewing and disposing of PRMs. The provides a means for concerned parties to submit such NRC's primary concern is to ensure that NRC-licensed proposals.

activities are conducted in a manner that ensures ade

C. REGULATORY POSITION

quate protection of public health and safety, the envi ronment, and the common defense and security. There 1. PETITIONS FOR RULEMAKING

fore, PRMs that raise a valid safety concern receive immediate NRC attention. In assessing the safety sig The materials that should be submitted in a PRM to nificance of petitions, the NRC considers the technical provide sufficient supporting information for the NRC

information submitted in support of the petition, the in to consider expedited processing are described in this formation available to the NRC, and whether the pro section. Because these materials must accompany any posal will meet the criteria of the backfit rule, 10 CFR rulemaking, they are usually developed by the NRC

50.109, if applicable. PRMs that are safety neutral (i.e., staff for each rulemaking. However, the rulemaking their implementation will result in an insignificant process would be expedited to the extent that the NRC

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staff can adopt supporting material prepared by the 1.3 Material To Show Conformance with Legal petitioner. Requirements The information in this section is intended to assist the petitioner in considering the impacts of each sug

1.1 Regulatory Text gested regulatory alternative in the process of de velop The suggested regulatory text necessary to accom ing a proposed rule. Section 5 of NUREG/BR-0058 1 plish the petitioner's desired amendment should be pre describes various legal and procedural requirements for sented and worded as directly, clearly, concisely, and rulemaking. The following legal requirements should unambiguously as possible. Suggested regulatory text be considered by the petitioner, as they must be con must, to the extent possible, be presented as amend sidered by the NRC staff.

ments to the NRC's regulations as codified in 10 CFR 1.3.1 Environmental Impact Under NEPA

Chapter I. The intent of the National Environmental Policy Act of 1969, as amended (NEPA) (42 U.S.C. 4321 et In developing suggested regulatory text, the peti seq.), is to integrate a consideration of the environmen tioner should consider the need for the regulation, the tal aspects of the proposed actions into the decision intended effect of the regulation, the basic message of making process. Many rulemaking proceedings will re the regulation, the different audiences being addressed quire environmental review. However, the NRC has by the regulation, and the way the primary audience found that certain types of proposed regulations may be would use the regulation. eligible for a categorical exclusion from the require ment for environmental review because these catego ries of actions do not individually or cumulatively have

1.2 Statement of Considerations for the a significant effect on the human environment. These Regulation are listed in 10 CFR 51.22(c).

The statement of considerations contains the sup If a PRM does not qualify for a categorical exclu plementary information portion of the preamble to the sion under 10 CFR 51.22(c), at a minimum the petition proposed rule and provides the regulatory history of the er should prepare an environmental report (see 10 CFR

PRM. The supplementary information section in the 51.68). Information on the contents of an environmen PRM should present the background information and tal report is found in 10 CFR 51.45. The petitioner enough specific details to inform interested persons of should ensure that pertinent information is provided in the issues involved. Background information is re the environmental report to assist the NRC in its analy quired for all PRMs to issue, amend, or rescind a sis to determine whether an environmental assessment regulation. Petitioners are encouraged to provide actual (EA) or an environmental impact statement (EIS) is operating experience and data to support risk-informed necessary.

and performance-oriented regulations and to assess the Additionally, if an EA (see 10 CFR 51.21) or an values (benefits) and impacts (costs) associated with EIS (see 10 CFR 51.20) is required for the PRM, the pe the proposed regulatory change. This information titioner may wish to prepare a draft EA or EIS. Informa would be essential in considering either enhancements tion on the preparation and content of an EA can be to or relaxation of existing requirements. As appropri found in 10 CFR 51.30 and of a draft EIS can be found ate, the supplementary information should include a in 10 CFR 51.70 to 51.73 (see 10 CFR 51.85).

discussion of the problem being addressed, how the proposed regulation would solve the problem, the alter 1.3.2 Information Collection Requirements natives considered in developing the proposed regula Under the Paperwork Reduction Act tion, and the economic and other impacts of the pro The Paperwork Reduction Act of 1995 (44 U.S.C.

posed regulation. The information provided in this 3501 et seq.) is intended to reduce the time, effort, and section may be used in the statement of considerations INUREG/BR-0058, "Regulatory Analysis Guidelines of the U.S. Nuclear that is published as part of the proposed rule in the Fed Regulatory Commission," Revision 2, November 1995. Copies of this and other NUREGs may be purchased from the Superintendent of Documents, eralRegister.If the issue being addressed in the petition U.S. Government Printing Office, P.O. Box 37082, Washington, DC

concerns safety or safeguards adequacy, cost is not a 20402-9328. Copies are also available from the National Technical Infor consideration. For this type of petition, information mation Service, 5285 Port Royal Road, Springfield, VA 22161. A copy is also available for inspection and copying for a fee in the NRC Public Docu that supports a contention concerning safety or safe ment Room, 2120 L Street, NW. (Lower Level), Washington, DC; the PDR's mailing address is Mail Stop LL-6, Washington, DC 20555; tele guards adequacy should be provided. phone (202)634-3273, fax (202)634-3343.

10.12-3

financial resources that the private sector expends in based upon employment during each pay period providing information to the Federal Government. It is for the preceding 12 calendar months.

also intended to reduce the cost-to the Federal Govern ment of collecting, using, and disseminating informa tion and to ensure that the information collected is use (b) A small organization is a not-for-profit orga nization which is independently owned and oper l

ated and has annual gross receipts of $5 million or ful. Each Federal agency must obtain approval from the less.

Office of Management and Budget (OMB) for each in formation collection activity that affects ten or more (c) A small governmental jurisdiction is a govern persons. ment of a city, county, town, township, village, With the PRM, the petitioner should provide an es school district, or special district with a population of less than 50,000.

timate and a justification for the assumptions used for the estimate of the public reporting burden for any (d) A small educational institution is one that is collection of information that would be required by the (1) Supported by a qualifying small governmental proposed regulation. The public burden estimate jurisdiction; or (2) Not state or publicly supported should be in terms of average hours needed per re and has 500 or fewer employees.

sponse for the collection of information and should in clude the time for reviewing instructions, searching ex (e) For the purposes of this section, the NRC shall isting data sources, gathering and maintaining the data use the Small Business Administration definition needed, and completing and reviewing the collection of of receipts (13 CFR 121.402(b)(2)). A licensee information. This information will allow the NRC to who is a subsidiary of a large entity does not quali prepare the clearance package to be submitted to the fy as a small entity for purposes of this section.

OMB and a Paperwork Reduction Act of 1995 state The petitioner should provide an estimate, includ ment to be included in the proposed rulemaking. ing the justification or assumptions used, of the annual

1.3.3 Economic Impact on Small Entities economic impact on small entities that would be caused by the proposed regulation by changes such as hard Under the Regulatory Flexibility Act The Regulatory Flexibility Act as amended (5 ware modifications, procedural changes for testing or maintenance, or hiring of additional personnel. The l U.S.C. 601 et seq.) requires each Federal agency to fit material should contain a description of and an estimate regulatory and informational requirements to the scale of the number of small entities to which the rule would of the entity being regulated. This statute requires each apply. The material should also describe projected re agency to consider the economic effect of its regula porting, recordkeeping, or other compliance require tions on small entities. For the NRC, this is particularly ments and the type of professional skills necessary for applicable to byproduct, source, and special nuclear the preparation of the reports or records. If alternatives material licensees. If the proposed regulation would are considered, it should be shown that the proposed have a "significant economic impact on a substantial regulation is the least costly alternative that will pro number of small entities," the NRC must prepare an ini vide adequate protection to the public and the licensees.

tial regulatory flexibility analysis. Economic impact should be presented in terms of the The size standards adopted by the NRC in 10 CFR total annual cost that would result from the proposed

2.810 to determine whether an entity is eligible for con regulation. The estimated percentage of small entities sideration as a "small entity" are as follows: among all licensees affected should be clearly stated.

This will allow the NRC to prepare the regulatory flexi

§ 2.810 NRC Size Standards. The NRC shall use bility analysis statement in the proposed rulemaking or the size standards contained in this section to deter to support a certification that the proposed action would mine whether a licensee qualifies as a small entity not have a significant economic impact on a substantial in its regulatory programs. number of small entities.

1.4 Regulatory Analysis (a) A small business is a for-profit concern and is a

- (1) Concern that provides a service or a concern The regulatory analysis is the most significant ele not engaged in manufacturing with average gross ment developed in support of a proposed rulemaking.

receipts of $5 million or less over its last 3 com This analysis is a structured evaluation of all factors pleted fiscal years; or (2) Manufacturing concern relevant to making a regulatory decision and is the basis with an average number of 500 or fewer employees for determining whether to proceed with a proposed

10.12-4

rulemaking. For this reason, it is important that the pe Generally, the appropriate level of detail to be in titioner ensure that all aspects of the regulatory analysis cluded in a regulatory analysis should be in proportion are fully developed and presented in a complete and to the safety significance, complexity, and cost impacts correct manner. of the proposed rule. Section 2.4 of NUREG/BR-0184 Information on the form and content of a regulatory contains information on the scope and level of detail analysis is provided in NUREG/BR-00581 and NU that should be included in the regulatory analysis. The REG/BR-0184. 2 The guidelines in NUREG/BR-0058 regulatory analyses supporting the relaxation or elimi also describe the key objectives that must be met by the nation of regulatory requirements that are marginal to regulatory analysis and provide a description of the reg safety can be markedly different from those required to ulatory analysis process. The guidelines contained in justify the issuance of additional requirements. Section NUREG/BR-0058 also establish a framework for ana 2.2 of NUREG/BR-0058 describes these differences lyzing the need for and consequences of a proposed reg and the documentation that must be included for those ulatory action, selecting a preferred alternative, and regulatory analyses supporting the relaxation or elimi documenting the analysis in an organized and under nation of marginal safety requirements.

standable format. NUREG/BR-0184 is being devel Elements that should be included and addressed in oped to provide more detailed information on preparing a regulatory analysis, as discussed in NUREG/

the regulatory analysis. When final, NUREG/BR-0184 BR-0058, include:

will provide the methodology and generic estimates for

"* A statement of the problem and objectives for the quantification of select attributes that are typically the proposed regulatory action;

included in NRC regulatory analyses.

"* Identification and preliminary analysis of al The regulatory analysis is intended to aid the NRC

in determining whether the proposed action is needed ternative approaches to the problem;

and to provide a clear and well-documented explana "* Estimation and evaluation of the values (bene tion regarding the particular action being recommen fits) and impacts (costs) for selected alterna ded. It is also intended to ensure that cost-effective reg tives, including consideration of the uncertain ulatory actions, consistent with providing necessary ties affecting the estimates;

protection for public health and safety and the common " Presentation of results, namely, the conclu defense and security, are identified for each proposed sions of the evaluation of values and impacts;

rule. Regulatory analyses must be sufficiently clear and and contain sufficient detail to enable NRC staff to easily recognize * The decision rationale for selection of the pro posed regulatory action.

The problem within the context of the existing regulatory framework; The elements of a regulatory analysis are presented below. NUREG/BR-0058 and NUREG/BR-0184

"* The proposed regulatory action; should be consulted for additional information on the

"* The conclusions reached and the bases for preparation of a regulatory analysis.

these conclusions;

1.4.1 Statement of the Problem and Objective

" The specific data and analytical methods used A concise summary of the problems or concerns and the logic followed that led to the conclu that need to be remedied and defined within the context sion that the proposed new requirement was of the existing regulatory framework should be pro appropriate and justified; vided in the statement of the proble

m. The nature and

" The sources and magnitude of uncertainties extent of the problem and why it requires action should that might affect the conclusions and the pro be presented clearly. In this context, a measure of the posed new requirement; and action's safety importance needs to be presented on ei

" The sensitivity of the conclusions to changes ther a qualitative or quantitative basis. This section of the regulatory analysis should demonstrate the need to in underlying assumptions and considerations.

take action and the consequences of taking no action for this problem.

2 NUREG/BR-0184, "Regulatory Analysis Technical Evaluation Hand For some regulatory issues there may be existing book" (August 1993 Draft). The final report is expected to be issued in NRC or Agreement State regulatory requirements or early 1997. guidance, industry programs, or voluntary efforts by li-

10.12-5

censees directed at the same or similar problem. These for all alternatives. This section generally is the longest activities and any variations in industry practice and and most complex of all the sections in a regulatory commitments among licensees should be identified and discussed to the extent applicable. The statement of the analysis.

In the context of the regulatory analysis, "values"

l_

problem should identify the specific class or classes of are defined as the beneficial aspects anticipated from a licensees, reactors, or other facilities affected by the proposed regulatory action such as, but not limited to, problem, as appropriate. A background discussion of the enhancement of health and safety, protection of the the problem should be included. For problems or con environment, promotion of the efficient functioning of cerns within the scope of the backfit rule (10 CFR the economy and private markets, and elimination or

50.109), the type of backfit needs to be identified. reduction of discrimination or bias. "Impacts" are de fined as the costs anticipated from a proposed regulato

1.4.2 Identification and Preliminary Analysis ry action such as, but not limited to, the direct costs to of Alternative Approaches NRC and Agreement States in administering the pro After the need for action has been established, the posed action and to licensees and others in complying regulatory analysis should next focus on identifying with the proposed action; adverse effects on health, reasonable alternatives that have a high likelihood of safety, and the natural environment; and adverse effects resolving the problems or concerns. An initial list of al on the efficient functioning of the economy or private ternatives should be identified and analyzed as early in markets.

the regulatory analysis process as possible. This list Categories of groups affected by the proposed reg should be reasonably comprehensive to ensure that the ulatory action should be identified. Groups may in range of all potentially reasonable and practical ap clude, but are not limited to, the general public, units of proaches to the problem are considered. In identifying State and local Government, Indian tribes, licensees of alternatives, the following issues should be considered: the NRC or Agreement States, employees of licensees,

(1) What action should be taken? (2) Whose responsibi contractors and vendors, the NRC, and other Federal lity should it be to take action? (3) How should it be agencies. For each affected group, the attributes that done? (4) When should it become effective? characterize the consequences of the proposed action should be identified.

Following the identification of the initial list of al ternatives, a preliminary analysis of the feasibility, val Estimates of value and impact are to be incremental ues, and impacts of each alternative usually eliminates best estimates relative to the baseline case, which is some of the alternatives. The elimination of alterna normally the no-action alternative. Best estimates, tives from further analysis can be based on factors such when possible, should be made in terms of the mean as clearly exorbitant impacts in relation to values, tech (expected value). However, depending on the level of nological impracticality, or severe implementation dif detail available from the data sources employed in the ficulties. The initial set of alternatives should be refined regulatory analysis, acceptable estimates could include because information is generated as part of the prelimi other point estimates. In this case, the rationale for the nary analysis of the alternatives. For each alternative use of estimates other than mean values should be that survives the preliminary screening, a general de provided.

scription of the activities required of licensees and the It is important to consider uncertainties in develop NRC to implement the alternative should be provided. ing a regulatory analysis. The sources and magnitudes The section on alternatives in the regulatory analy of uncertainties in value and impact estimates and the sis should list all significant alternatives considered. A methods used to quantify uncertainty estimates should brief explanation of the reason for elimination should be discussed in all regulatory analyses. A sensitivity be included for alternatives not selected for further analysis can be used in addition to or in lieu of a formal study. uncertainty analysis. Hypothetical best- and worst-case values and impacts can be estimated for sensitivity

1.4.3 Estimation and Evaluation of Values and analyses.

Impacts Estimates of value and impact should be made by An estimation and evaluation of values and im year for the entire period that groups will be affected by pacts on the alternatives that survive the screening the proposed regulatory action. For licensed facilities, process should be provided in this section of the regula estimates should be made for the remainder of the oper tory analysis. The level of detail need not be the same ating license or projected useful life of the facility (i.e.,

12-6 II

extended into the license renewal period). For nuclear 1.4.5 Decision Rationale for Selecting the power reactors, separate estimates for a license renewal Proposed Action term should be made if the analyst judges that the re The reason the proposed action is recommended sults of the regulatory analysis could be significantly over the other alternatives considered should be ex affected by the inclusion of such a renewal term. If not, plained in this section of the regulatory analysis. The the basis for the judgment or conclusion that there decision criteria used for selecting the proposed action would not be a significant effect should be stated for fu should be identified. The criteria should include, but ture reference. are not limited to:

"* The net value and value-impact computations;

Whenever possible, value and impact estimates should be expressed in monetary terms and in constant "* The relative importance of attributes that are dollars from the most recent year for which price ad quantified in terms other than monetary;

justment data are available. Consequences that cannot "* The relative importance of unquantifiable be expressed in monetary terms should be described attributes;

and quantified in appropriate units to the extent pos

" The relationship and consistency of the pro sible. Many regulatory actions, such as those affecting non-power reactor and materials licensees, may not be posed alternatives with the NRC's legislative supported by an available probabilistic risk assessment mandates, safety goals, and policy and plan ning guidance that are in effect at the time the (PRA) analysis. Also, probabilistic analysis techniques may not be practical for some actions. The analyst proposed alternative is recommended; and needs to make every reasonable effort to apply alterna " The impact of the proposed action on existing tive tools that can provide a quantitative perspective or planned NRC programs and requirements.

and useful trends concerning the value of the proposed action. Even inexact quantification with large uncer In addition, this section should also include a state tainties is preferable to no quantification, provided the ment of the proposed generic requirement, a statement uncertainties are appropriately considered. The analyst as to whether the proposed action would increase or re should use care to verify that neither values nor impacts lax (or reduce) existing requirements, and a statement are double counted. Values and impacts that are deter on whether the proposed action is interim or final, and if mined to be unquantifiable should be identified and dis interim, the justification for imposing the proposed re cussed qualitatively. An attribute should not be omitted quirement on an interim basis.

from a regulatory analysis document simply because it 1.5 Response to the Backfit Rule is determined to be unquantifiable.

Backfitting is defined as the modification of or addition to systems, structures, components, or design

1.4.4 Presentation of Results of a facility; or the design approval or manufacturing li cense for a facility; or the procedures or organization re A net value calculation, i.e., the summation of pos quired to design, construct, or operate a facility; any of itive and negative attributes, should be computed and which may result from a new or amended provision in displayed in the regulatory analysis for each alternative the NRC rules or the imposition of a regulatory staff considered. This calculation requires, to the extent pos position interpreting the NRC rules that is either new or sible, that all values and impacts be quantified in different from a previously applicable staff position.

present-worth monetary terms and added together A backfit may be imposed on a nuclear power facil (with the appropriate algebraic signs) to obtain the net ity that already provides adequate protection of public value in dollars. The analyst may elect to display the re health and safety and common defense and security sults based on the ratio of values to impacts. However, only if the backfit analysis as required by 10 CFR

this method of display is supplemental and not a re 50.109 indicates that (1) there would be a substantial in placement for the net value method. In the ratio meth crease in the overall protection of public health and od, the numerator represents the sum of all quantifiable safety or the common defense and security derived present-worth estimates for values, while the denomi from the backfit and (2) the direct and indirect costs that nator does likewise for impacts. The net value method would result from the implementation of the backfit are is generally the preferred method of the two because it justifie*h-.A backfit analysis is not required when (1) a provides an absolute measure of the aggregate net effect modification is necessary to bring a facility into com of the proposed action. pliance with a license or the rules or orders of the NRC,

10.12-7

or into conformance with written commitments by the document should be considered in the values and im licensee, (2) the regulatory action is necessary to ensure pacts assessment of the regulatory analysis. The format that the facility provides adequate protection to the and content of any typical NRC regulatory guide could health and safety of the public and is in accord with the be used for the preparation of a guidance document.

common defense and security, or (3) the regulatory ac NUREG/BR-0058 (the NRC Regulatory Analysis tion involves defining or redefining the level of protec Guidelines) states that safety goal evaluation is applica tion to public health and safety or common defense and ble only to power reactor regulatory initiatives consid security that should be regarded as adequate. ered to be generic safety enhancement backfits defined Details of the backfitting process and the prepara by the backfit rule (10 CFR 50.109). Relaxations of re tion of a backfit analysis are provided in NUREG- 1409, quirements affecting nuclear power plants are not sub

"Backfitting Guidelines." 3 Relaxations of require ject to the safety goal evaluation requirements.

ments affecting nuclear power plants that result in sig

2. PROPOSALS FOR REGULATORY

nificantly reduced regulatory burden with minimal im GUIDANCE DOCUMENTS

pact to overall safety (safety neutral) are not backfits and thus do not fall within the scope of the backfit rule. Regulatory guidance documents (RGDs) are NRC

However, a relaxation of requirements is subject to a documents such as regulatory guides, bulletins, generic regulatory analysis as described in section 1.4, "Regu letters, and sections of Standard Review Plans (includ latory Analysis," of this guide. ing branch technical positions). These documents do not have the force and effect of regulations, but they fre Section 2.3 of NUREG/BR-0058' provides infor quently provide guidance on methods or positions ac mation on preparing the backfit analysis. Section 2.0 of ceptable to the NRC staff for compliance with NRC

NUREG/BR-0184 2 describes how the information re regulations. Most of these RGDs are issued for public quired for the backfit analysis should be included in the comment so that licensees and the public can partici regulatory analysis.

pate in formulating the final staff positions.

1.6 Guidance Document, When Applicable Any submittal recommending changes to an exist A regulatory guide is frequently developed to pro vide guidance on methods for meeting a performance ing RGD must meet the following criteria before it can be considered by the NRC office responsible for that particular document.

1L

based regulation. Performance-oriented rather than programmatic, prescriptive, and compliance-based 1. The proposed change to an RGD is applicable regulations could be developed using risk insights to a number of licensees rather than to a partic (such as those obtained from probabilistic risk assess ular licensee.

ment) and safety goal 4 considerations to establish regu latory objectives. This approach should result in im 2. The submittal contains a detailed analysis to proved safety by allowing more available resources to ensure that the proposed alternatives will com be used for the more important safety issues. However, ply with NRC regulations and the require the use of performance-oriented regulations will entail ments that public health and safety, the envi developing performance criteria and methods of ronment, and the common defense and measuring performance. In addition, changing to security are adequately protected.

performance-oriented regulations means that details, if 3. The submittal contains an estimate of costs for needed to show an acceptable way of complying with the proposed alternatives compared with costs the regulations, would be published in a guidance docu for the methods or positions in the existing ment. The effect of the method adopted in the guidance RGD.

4. The text of the proposed changes to the RGD is

3 D.P. Allison, J.H. Conran, C.A. Trottier, "Backfitting Guidelines," NU included in the submittal, and the format of the REG-1409, USNRC, July 1990. Copies may be purchased from the U.S.

Government Printing Office, P.O. Box 37082, Washington, DC text follows that of the existing RGD as much

20402-9328 (telephone (202)512-2249); or from the National Technical as possible.

Information Service by writing NTIS at 5285 Port Royal Road, Springfield, VA 22161. Copies are available for inspection or copying for a fee from the Submittals recommending changes to an existing NRC Public Document Room at 2120 L Street NW., Washington, DC; the PDR's mailing address is Mail Stop LL-6, Washington, DC 20555; tele RGD will be considered by the NRC office responsible phone (202)634-3273; fax (202)634-3343. for that document. The responsible NRC office must

4 See "Safety Goals for the Operations of Nuclear Power Plants; Policy State first determine whether the submittal meets the criteria ment," August 4, 1986 (51 FR 28044), as corrected and republished on Au gust 21, 1986 (51 FR 30028). above. Proposals regarding RGDs should be addressed

10.12-8

to the Director of the NRC office responsible for the nonproliferation; and management of related issuance of these RGDs. The RGDs and the responsible decommissioning.

NRC offices are as follows.

• Standard Review Plans-Issuing office Regulatory Guides-Office of Nuclear Regu latory Research Within a reasonable time after a proposal to change an existing RGD has been received, the Director of the Bulletins, Generic Letters-Office of Nuclear NRC office responsible for the issuance of the RGD

Reactor Regulation for all proposals related to should advise the party who made the proposal in writ construction, operation, and decommission ing whether the modification of the RGD will proceed ing of nuclear reactor facilities. Office of Nu or will not proceed in whole or in part, with respect to clear Material Safety and Safeguards for pro the proposal, and the reason for the decision.

posals related to activities involving safety, quality, approval, and inspection of the use and

D. IMPLEMENTATION

handling of licensed nuclear and other radioac tive materials; nuclear fuel fabrication and fuel The purpose of this section is to provide informa development; medical, industrial, academic, tion to licensees, applicants, and the public regarding and commercial uses of radioactive isotopes; the NRC staff's plans for using this regulatory guide.

material control, accounting, and physical Except in those cases in which an applicant pro protection of special nuclear material; safe poses an acceptable alternative method for complying guards design basis threat; transportation of with specified portions of the NRC's regulations, the nuclear materials; spent fuel storage at a loca methods described in this guide will be used in the tion away from a reactor; safe management evaluation of petitions for rulemaking submitted under and disposal of low-level and high-level radio 10 CFR 2.802 and of changes to regulatory guidance active waste; international safeguards and documents.

10.12-9

REGULATORY ANALYSIS

The Administrative Procedure Act requires each course of action after evaluating public comments re Federal agency to give interested persons the right to ceived on the proposed rulemaking. The majority of the petition for the issuance, amendment, or repeal of a public comments stated that it is unnecessary to codify rule. This regulatory guide will facilitate more expedi this guidance because it is general guidance and does tious disposition of petitions by the NRC, and it does not impose any mandatory requirements. Although an not affect any existing rights. The cost involved in its alternative would be to not provide any guidance, this promulgation and implementation is necessary and alternative clearly would not accomplish the original appropriate. objective. Because the majority of the material in this regulatory guide has already been developed during the The NRC originally considered a rulemaking on proposed rulemaking activity, the resources for pre the type and level of information needed for expedited paring this guide are insignificant and outweighed by processing of PRMs. The NRC decided against this the benefits.

l

10.12-10

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