ML20133E411
| ML20133E411 | |
| Person / Time | |
|---|---|
| Issue date: | 12/31/1996 |
| From: | NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | |
| References | |
| TASK-*****, TASK-RE REGGD-10.012, NUDOCS 9701130033 | |
| Download: ML20133E411 (12) | |
Text
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i eow U.S. NUCLEAR REGULATORY COMMISSION December 1996 i
U @fg?%)REGULATORY GUIDE O
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OFFICE OF NUCLEAR REGULATORY RESEARCH REGULATORY GUIDE 10.12 (Draft issued as DG-0010)
PREPARATION OF PETITIONS FOR RULEMAKING UNDER 10 CFR 2.802 l
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 pr cess 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 subm:tting 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 I
The information collections contained in this regu-Part 2," Rules of Practice for Domestic Licensing Pro-latory guide are covered by requirements that were ap-ceedings and issuance of Orders," in Title 10 of the proved by the Office of Management and Budget, ap-Code of Federal Regulations (10 CFR 2.802).
provat number 3150-0136.
The minimum requirements and other information The public reporting burden for persons submit-for submittal of a PRM by interested parties are pro-ting PRMs to the NRC containing information that vided in 10 CFR 2.802(c). An individual may consult would allow the NRC to process the PRM in a more ex-with the NRC staff before filing a PRM. Ilowever, the 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 assistance that may be provided by the NRCstaffislim-response, including the time for reviewing instructions, ited by 10 CFR 2.802(b) to plescribing the process, ex-searching existing data sources, gathering and main-plaimng the existing regulations and their basis, and as-taining the data needed, and completing and reviewing sisting the prospective petitioner to clarify a petition.
the collection of information. Send comments on any The NRC staff may not draft or develop text or alterna-apect of this collection of information, including live approaches for petitioners.
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 13]Sl@ NRC. GOV; and to the Desk Officer, Office of
, delineates factors the NRC uses in setting priorities for Information and Regulatory Affairs, NEOll-10202 g3;f O
twac stort Atonycriot.s Tne osdes are issued m tne foiiow'r.g inn boad d+ sons
.eg_.s.. _ed,o de_e._ e a_e,_,_ a_ m.
tion as methods acceptabie to the NAC staff for impiamentmg sDOOfic parts a the Cur 7" 1 Power Reactors 6 Products y
massce a regulahons techr% Ques used by the staff m evabatmg spectftc protFems or PCs-2 Aesearch and Test A66Cfors 7 Transporta!wn tulated eccadents. and data needed cy the N4C sta9 m its rerew of apptecations for per-3 Fueis ar<s Ma'eriais Fac+ ties 8 Occucational Hestn rnets and hcenses Regulatory guides are not substitutes for regdates and comphance 4 Env'ronments and S*ng 9
Antitr st and Financial Rev'ew u
with them is not requved Methoos and soutions omerene from those set out m the gwdes
$ Matensa and Piant Protection to Geners will be acceptatae d they provce a bases for the fmdings recesite to the issuance or con-l tmuence of a permet or hcense by the Comrmas.on l
S.ngie copies of reguintory gwoes mov be ornained free of charge by wr*ng the Othee of TNs gade was issued after cons,dwaton of comments received from the puche Com-Administra'on At'ention oistobuten and Mail Sev, ices.Section u s Nuclear Reguatory menis and sog2. hor. fo, improvements m inoe ged. e encoed. r and C ommissen % ton oC 20sss om o,
,. oomtu2eo gedes will De rev* sed as approprsete to accommodate comments and to reH4Cf new W J
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staff can adopt supporting material prepared by the 1.3 Afaterial 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-l.1 Regulatory Text gested regulatory alternative in the process of de velop-ing a proposed rule. Section 5 of NUREG/BR-00583 The suggested regulatory text necessary to accom-describes various legal and procedural requirements for plish the petitioner's desired amendment should be pre-rulemaking. The following legal requirements should sented and worded as directly, clearly, concisely, and be considered by the petitioner, as they must be con-unambiguously as possible. Suggested regulatory text sidered by the NRC staff.
must, to the extent possible, be presented as amend-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, llowever, the NRC has by the regulation, and the way the primary audience found that eertain 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).
U a P M does not qualify for a categorical exclu-The statement of considerations contains the sup-sion under 10 CFR 51.22(c), at a minimum thgetition-piementary information portion of the preamble to the er a prep te n env onmental report (see 10 CFR proposed rule and provides the regulatory history of the
). In ormatmn on the contents of an environmen-PRM. The supplementary information section in the 5y The petitioner
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PRM should present the background information and dould ensure that pert.inent information is provided in enough specific details to inform interested persons of the issues involved. Backgrounit information is re-tlie environmental report to assist the NRC in its analy-sis t determme whether an environmental assessment quired for all PRMs to issue, amend, or rescind a
) m an en nme a sp statement @) is regulation. Petitioners are encouraged to provide actual
"' " * 'Y' operating experience and data to support risk-informed 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.
fund 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 1.3.2 Information Collection Requirements proposed regulation would solve the problem, the alter-Under the Paperwork Reduction Act natives considered in developing the proposed regula-The Paperwork Reduction Act of 1995 (44 U.S.C.
tion, and the economic and other impacts of the pro-3501 et seq.)is intended to reduce the time, effort, and posed regulation. The information provided m this section may be used in the statement of considerations iNeui:c tin.0058. Regulatory Analyus Guidelmes of the U.S. Nuclear Regulatory Cornnunion? Reson 2Snentber 1995 Copics of this and that is Eublished as Eart of the EtoEosed rule in the Fed-other NU RI.Gs may be purchased from the superintendent of Documents.
cralRegister. lf the issue being addressed in the petition U.s. Gosernment Pnnnng Omcc, PO Box 37082. washington. DC mahon scrucc. 5285 Port Roy al Road,gm the Nahonal Techn 0 4 pin an abo asailable Concerns safel7 or safeguards adeliuaCy, Cost is not a spnngfi(Id. s A 22161. A copy as consideration. For this type of petition, information aho as mbble for inspechon and top) mg for a fec in the N RC Pubhc Docu-that supports a contention concerning safety or safe-
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rulemaking. For this reason, it is important that the pe-Generally, the appropriate level of detail to be in-
'itioner ensure that all aspects of the regulatory analysis cluded in a regulatory analysis should be in proportion
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are fully developed and presented in a complete and to the safety significance, complexity, and cost impacts l
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correct manner, of the proposed rule. Section 2.4 of NUREG/IlP.-0184 Information on the form and content of a regulatory contains information on the scope and level of detail i
analysis is provided in NUREG/BR-00581 and NU-that should be included in the regulatory analysis. The REG /llR-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 (an be markedly different from those required te ulatory [nalysis process. The guidelines coatained 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 and the documentation that must be included for timse lyzing the need for and consequences of a proposed reg-ulatory action, selecting a preferred alternative, and regulatory analyses supporting the relaxation or ehmt-documenting the analysis in an organized and under-n hon of m rginal 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 NHC ternative approaches to the problem; in determining whether the proposed action is needed 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,includingconsideration of the uncertain-O ulatory actions, consistent with providing necessary ties affecting the estimates;
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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 The decision rationale for selection of the pro-TCC"8"IZ" posed regulatory action.
The problem within the context of the existing The elements of a regulatory analysis are presented regulatory framework; below. NUREG/BR-0058 and NUREG/BR-0184 The praposed regulatory action; shoukt be consulted for additional information on the The conclusions reached and the bases for prepar tion f regul tory analysis.
these conclusions; 1.4.1 Statement of the Problem and Objectise 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 problem. The nature and The sources and magnitude of uncertainties extent of the problem md why it requires action should that might affect the conclusions and the pro.
be praented clearly. In this context, a measure of the poseu new requirement; and actioni safety importance needs to be presented on ei-ther a qualitative or quantitative basis. This section of The sensitivity of the conclusions to changes the regulatory analysis should demonstrate the need to a
in underlying assumptions and considerations.
take action and the consequences of taking no action for this problem.
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For some regulatory issues there may be existing
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NURr G llR ulS4. " Regulatory Analpn technical laaluateun lland-NRC or Agreement State segulatory requirements or book"(August IVO Dratu The Dnal report n capcoted to be mued in euh en7.
guidance, industry programs, or voluntary efforts by h,-
10.12 - 5
w U.S. NUCLEAR REGULATORY COMMISSION December 1996 lc ua
@**g%)
REGULATORY GU DE o}
f OFFICE OF NUCLEAR REGULATORY RESEARCH 8
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 pen 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 The information collections contained in this regu-Part 2," Rules of Practice for Domestic Licensing Pro-latory guide are covered by requirements that were ap-ceedings and issuance of Orders," in Title 10 of the proved by the Office of Management and Budget, ap-Code of Federal Regulations (10 CFR 2.802).
provat number 3150-0136.
p The minimum requirements and other information The public reporting burden for persons submit-for submittal of a PRM by mterested parties are pro-t ting PRMs to the NRC containing information that vided in 10 CFR 2.802(c). An individual may consult would allow the NRC to process the PRM in a more ex-with the NRC staff before fihng a PRM. However, the 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 assistance that may be provided by the NRC staf f islim-response, including the time for reviewing instructions, ited by 10 CFR 2.802(b) to describing the process, ex-searching existing data sources, gathering and main-i plaining the existing regulations and their basis, and as-taining the data needed, and completing and reviewing sisting the prospective petitioner to clarify a petition.
the collection of information. Send comments on any The NRC staff may not draft or develop text or alterna-aspect of this collection of information, including 1
tive approaches for petitioners.
suggestions for reducing the burden, to the Information l
This regulatory guide provides guidance to persons and Records Management Branch (T-6 F 33), U.S. Nu-I who submit PRMs to the NRC concerning the type and clear Regulatory Commission, Washington, DC I
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 D.ISl(T NRC. GOV; and to the Desk Officer, Office of i
, delineates factors the NRC uses in setting priorities for information and Regulatory Affairs, NEOB-10202 l
l tMRC M GL't.ATORY GL IDI $
The Oudes are issued in the foHomng ten broad divisions
@ji ae-a,0,, o_.e ss-descre..~e ev..e,o th. p.c s
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tion as methods acceptabie to the NRC staff for ernpiernentmg specAc parts of the Com-1 power Reactors 6 Products I
2 Research and Test Aeactors 7 Transportahor k
rmsson s regulatsons techruquee used by the staff e evahaatmg specific problems or pos-i tulal3d acridents and data needed by the NRC sta# in its reicew of applications for per.
J Fue+s and Matenais Facmhes e Occupational Hesth truts and hcenses Regulatory gudes are not substitutes for reguahons and compbance 4 gny,ronrnental and Setmg 9 Arrotrust and Fmancial Aeview I
with them e not requied Memods ed solutions d#e'ent from those set out e the gude's
$ Materies and Rent Protection 10 Geners I
will be acceptaDie if they provide a bas a for me findogs requisite to the 4swarte or con-l turbance of a permit or lice 4e by the Commsa,on Sing:e coo es of regvatory gudes may be obta.ned free of charge by wr hng the Omce of Trks gude e as saued a'ter considerat on of comrnents received from the pubhc Com-Admmistrat ott Artention Distreuhon and Mail Serwces Sectron. U S Nuclear RogJatory ments and suggestions for ireprovements in therse gudas are ortouraged at all times and Comemssion Washmgton. DC 20S55-000! or Dy tan at p004t5 2260 gudes ad be revised as appropriate to accommodate comments and to renect rew n
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Isso*1 gudes may aso be purchased from it e Nat<onal Tecnrwcal information Sarwce on I
\\d Wntten commenre may be suDmrt'ed to the Ades Aaview and Directiven Beanch. DFIPS a standmg oroor bases Demos on stus saw e may be obtened by atit.ng N fis 5285 Port
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(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 sponst and a person suppong by th type of information described in this guide will be given the next priority.
is not required to respond to, a collection ofinfonnation unless it displays a currently valid OMil control num-FROPOSALS l'OR ltEGUIATORY GUIDANCh' ber. Ihe collectmns associated with this regulatory DOCUM ENTS gmde are voluntary.
There is also a need to clarify the procedure for suh.
II. DISCUSSION mitting proposals from concerned pa'rties to change ex-isting regulatory guidance documents (RGDs). RGDs PETITIONS FOR RULEMAKING include documents such as regulatory guides. bulletins, The NRC is developing this guidance to expedite generic letters, and sections of Standard Review Plans the processing of PRMs by the NRC by encouraging (including branch technical positions). llecause these the submittal af PRMs accompanied by strong techni.
documents do not have the force and effect of regula-cal support. The NRC believes that technical support.
tions, but serve to identify or clarify methods or posi-ing information in the depth discussed in this puide tions acceptable to the NRC staff for compiance with wouH cffectively expedite the processing of PRMs. If a NRC regulations, petitioning for a change in a RGD is petitioner follows this guide, the N RC should be abie to not normally an effective way to raise a safety concern review and process the PRM more expeditiously.
(unless tbe petitioner is attempting to point out that a current RGD contains defective guidance that does not in proposing improvements to NRC regulations to comply with the regulation and af fects safety).
reduce the regulatory burden, to enhance safety, or for other objectives, petitioners are encouraged to provide Any party w ho has a specific concern about the safe supporting information demonstrating that the pro.
operation of a nuclear power plant or a nuclear materi-posed chang u ill result in the desired outcome. Peti.
als facility should use the process established in tioners are au encouraged to use publicly available 10 CFR 2.206, concerning the modification, suspen-safety information to support the cost effectiveness of sion, or revocation of a license, to bring these concerns the safety enhancements for which they are petitioning.
to the attention of the NRC. Likewis., anyone who is d
concerned Qat an existing NRC regulat;on does not i
PRMs are evaluated and scheduled for the NRC)provide adequate protection to public health and safety, review and disposition by co'isidering 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 i
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-mine the disposition of the petition, that is, whether the The public and We nuclear industry currently par-petition will be accepted through a rulemaking action ticipate in formulating the final RGDs through the pub-or denied. The degree to which a supporting analysis is lic comment process for new or revised RDGs pro-complete, accurate, and thorough will affect how rapid.
posed by the NRC. Ilowever, other than for regulatory ly the NRC staff is able to make such a determination, guid,, there is no formal administrative framework for any concerned party to submit proposals recommend-Consideration of the safety significance is the first ng changes to existing RGDs. This regulatory guide criterion for reviewing and disposing of PRMs. The provides a means for concerned parties to subniit su'ch NRC's primary concern is to ensure that NRC-licensed proposals.
I 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 nssessing 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. Elecause 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 appheable. PRMs that are safety neutral (i.e.,
staff for each rulemaking. Ilowever, the rulemaking their implementation will result in an insignificant process would be expedited to the extent that the NRC 10.12 - 2
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staff can adopt supporting material prepared by the 1.3 Material To Show Conformance with Legal j
petitioner.
Requirements
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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-s ing a proposed rule. Section 5 of NUREG/BR-00581 The suggested regulatory text necessary to accom-describes various legal and procedural requirements for plish the petitioner's desired amendment should be pre-rulemaknig. The following legal requirements should sented and worded as directly, clearly, concisely, and be considered by the petitioner, as they must be con-unambiguously as possible. Suggested regulatory text sidered by the NRC staff.
must, to the extent possible, be presented as amend.
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ments to the NRC's regulations as codified in 10 CFR 1.3.1 Environmental Impact Under NEPA l
Chapter I.
The intent of the National Environmental Policy j
Act of 1969, as amended (NEPA)(42 U.S.C. 4321 et 3
in developing suggested regulatory text, the peti-seq.), is to integrate a consideration of the environmen-
)
i tioaer 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-l the regulation, the different audiences being addressed quire environmental review, However, the NRC has l
by the regulation, and the way the primary audience found that certain types of proposed regulations may be i'
j would use the regulation.
eligible for a categorical exclusion from the require-l ment for environmental review because these catego-ries of actions do not individually or cumulatively have l
1.2 Statement of Considerations for the a significant effect on the human environment. These Regulation are listed in 10 CFR St.22(c).
U es not quaMy for a categorical exclu-The statement of considerations contains the sup-sion under 10 CFR 51.22(c), at a minimum the petitmn-plementary information portion of the preamble to the er should prepare an environmental report (see 10 CFR
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proposed rule and provides the regulatory history of the 51.68). Information on the contents of an environmen-I,RM. The supplementary mformation section in the tal report is found m. 10 CFR 51.45. The petitioner PRM should present the background informat. ion and should ensure that pertinent information is pmvided m.
encugh specific details to inform irterested persons of
"'" *"* ental report to assist the NRC in its analy-the issues involved. Backgrounit information is re-sis to determm.e whether an environmental assessment quired for all PRMs to issue, amend, or rescind a (EA) or an envirenmental impact statement (EIS) is regulation. Petitioners are encouraged to provide actual operating experience and data to support risk-informed 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 1.3.2 Information Collection Requirements proposed regulation would solve the problem, the alter-Under the Paperwork Reduction Act natives considered in developing the proposed regula-The Paperwork Reduction Act of 1995 (44 U.S.C.
Imn, and the economic and other impacts of the pm-3501 et seq.)is intended to reduce the time, effort, and posed regulation. The mformation pmvided in this section may be used in the statement of considerations INURLO'llR 0058. " Regulatory Analysis Guidehnes of the U.S. Nuclear
"'8"'*'"'6 """""'n." Remn 2. Noumber 1991 Copics of thn and that is published as Eart of the ErOEosed rule in the Fed-other NUREGs may be purchased from the supenntendent of Documents, eralRegister. U the issue being addressed in the petition u.s Gournment ermiing offwe. Po no 370x2. washingion. De opies an alai ava able from the Nanonal Techmcal lnfor-cenCernS safety or safeSuards ade9uaCY, Cost is not a mation seruce. 5285 Port Royal Road, springfield. VA 22:61. A copy n consideration. For this type of petition, information ako av adable for inspection and copy ng for a fec en the N RC rubhc Docu-Roorn. 2120 L sucet. y (twer Imlh washington, DC; the
"'"'.smaihng address is Mail stop I.l A. Washington. DC 20555; tele.
that suppoils a contention concerninS safety or safe-PDR guards adequacy should be provided.
P one (202/>34-3273. rax (202x>34-3341 h
10.12 - 3
l 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-(b) A smaH organization is a not-for-profit orga-lion and to ensure that the information collected is use-niz tion which is independently owned and oper-ful. Ecch Federal agency must obtain approval from the ated and has annual gross receipts of S5 milhon or i
I'
- Office of Management and Budget (OMB) for each in-1 farmation 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 timate and a justification for the assumptions used for of less than 50,000.
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the estimate of the public reporting burden for any (d) A small educational institution is one that is-collectmn ofinformation that would be required by the (1) Supported by a qualifying small governmental proposed regulation. T.he pubh.c burden estimate should be m. terms of average hours needed per re-junsdiction; or (2) Not state or publicly supported i
sponse for the collection of information and should m.-
and has 500 or fewer employees.
(
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)b 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-i ment to be meluded in the proposed rulemaking.
ing the justification or assumptions used, of the ant.ual 1.3.3 Economic Impact on Small Entities economic impact on small entities that would be caused j
Under the Regulatory Flexibility Act by the proposed regulation by changes such as hard-ware modifications, procedural changes for testmg or The Regulatory Flexibility Act as amended (5 maintenance, or hiring of additional personnel. The 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-i 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 preposed 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.
(a) A small business is a for-profit concern and is a 1.4 Regulatory Analysis
-(l) 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.
receip's of 55 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 i
with an average number of 500er fewer employees for determining whether to proceed with a proposed 10.12 - 4 I
l
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 o
are fully developed and presented in a complete and to the safety significance, complexity, and cast impacts
('
correct manner.
of the proposed tule. Section 2.4 of NUREG/BR-0184 contains inform tion n the scope and level of detail Information on the form and contem of a regulatory analysis is provided in NUREG/BR-00581 and NU-th t should be included in the regulatory analysis.The REG /BR-0184.2 The guidelines in NUREG/BR-0058 mgul tory analym supporting the relaxation or elimi-also describe the key objectives that must be met by the n tion of agulatory 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 and the documentation that must be included for those lyzing the need for and consequences of a proposed reg-ulatory action, selecting a preferred alternative, and regulatory analyses supporting the relaxation or ehmi-documenting the analysis in an organized and under-nation d marginal safety mquirements.
standable format. NUREG/BR-0184 is being devel-Elements that should be inchided 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.
1 identification and preliminary analysis of al-
+
The regulatory analysis is intended to aid the NRC ternative approaches to the problem; I
in determining whether the proposed action is needed 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-O 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 The decision rationale for selection of the pro-recognize-posed regulatory action.
The problem within the context of the existing The elements of a regulatory analysis are presented regulatory framework; below. NUREG/BR-0058 and NUREG/BR-0184 The proposed regulatory action:
should be consulted for additional information on the prep ration of a regulatory analysis.
The conclusions reached and the bases for 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 problem. The nature and The sources and magnitude of uncertainties extent of the proHem and why it requires action should that might affect the conclusions and t"e pro-he presented clearly. In this context, a measure of the posed new requirement; and action's safety importance needs to be presented on ei-ther a qualitative or quantitative basis. This section of The sensitivity of the conclusions to changes the regulatory analysis should demonstrate the need to
=
in underlying assumptions and consideration' take action and the consequences of taking no action for this problem.
For some regulatory issues there may be existing C
DI.G nR-0184. -Regulatory Anal)m 'lechrucal I%aluanon lland.
NRC or Agreement State regulatory requirements or book (August 1993 Draht t he final report is espected to be nsued in
~
early 1997.
guidance, industry programs, or voluntaly efforts by 11-10.12 - 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 analysis.
discussed to the extent applicable. The statement of the In the context of the regulatory analysis," values" 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 l
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 CFIt 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 Identificatlan and Preliminary Analysis rv action such as, but not limited to, the direct costs to of Alternative Approaches ERC 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 advec 4e effects resolving the problems or concerns. An initiallist 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 Cmegories of groups affected by the proposed reg-should be reasonably comprehensive to ensure that the ulMory action should be identified. Groups may in-range of all potentially reasonable and practical ap-ciudt bm are not limited to, the general public, units of proaches to the problem are considered. In identifymg State and local Government, Indian tribes, licensees of alternatives, the following issues should be considered:
the NRC or Agreement States, employees oflicensees, (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) llow should it be acencies. For each affected group, the attributes that done? (4) When should it become effective?
characterize the consequences of the proposed action Following the identification of the initiallist of al.
should be identified.
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 frem 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). Ilowever, 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 heensees and the It is important to consider uncertainties in develop-NRC to implement the alternative should be provided.
mg a regulatory analysis. The sources and magnitudes t
The section on alternatives in the regulatory analy-of uncertainties in value and impni 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 5
be included for alternatives not selected for further analysis can be used in addition to or in lieu of a f ormal study.
uncertainty analysis. Ilypothetical best-and worst-case values and impacts can be estimated for sensitivity 1.4.3 Estimation and Evaluation of Values and analyses.
IS P"CI*
Estimates of value and impact should be made by An estimation and evaluation of values and im-y ear for the entire period that groups will be affected by pacts on tne alternatives that survise 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.,
10.1.S 6 1
l
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
/
j term should be made if the analyst judges that the re-The reason the proposed action is recommended V
suits of the regu!atory 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 posed alternatives with the NRC's legislative non. power reactor and materials licensees, may not be mandates, safety goals, and policy and plan-supported by an available probabilistic risk assessment ning guidance that are in effect at the time the (PRA) analysis. Also, probabilistic analysis techniques proposed alternative is recommended; and may not be practical for some actions. The analyst needs to make every reasonable effort to apply alterne-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 In addition, this sectmn should also m. elude a state-action. Even inexact quantification with large uncer-nwnt o epmpme gene e requ ement, a statenient tainties is preferable to no quantification, provided the O
uncertainties are appropriately considered. The analyst as to whemer dw pmpmed aedon wouM hease or m
' * ("' "'" ) ' ",
"E *4."
- ents, an a statenwnt Q
should use care to verify that neither values nor impacts e e wpmp actmn is indm odnal, anM are double countt.3. Wlues and impacts that are deter-pn mined to be unquantifiable should be identified and dis-mtedm, um juMkanon Mr impWng dw pmpmed m cussed qualitatively. An attribute should not be omitted quirement on an intenm basis.
from a regulatory analysis document simply because it 1.5 Response to the llackfit Rule is determined to be unquantifiable.
13ackfitting is defined as the modification of or addition to systems, structures, components, or design of a facility; or the design approval or manufacturing li-1.4.4 Presentation of Results 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 diffemnt fmm 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 ir 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. Ilowever, 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 substantiat 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 Q
is generally the preferred method of the two because it justifiedc 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
l 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/13R-0058 (the NRC Regulatory Analysis tion mvolves defining or redehnmg the level of protec-GuidelinesWes thaNfdy goM mlusiod is amice 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-
"llackfitting 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-pact to overall safety (safety neutral) are not backfits GUIDANCE DOCU51ENTS and thus do not fall within the scope of the backfit rule.
Regulatory guidance documents (RGDs) are NRC Ilowever, 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 Section 2.3 of NUREG/BR-0058 provides infor-not haw the force and effect of regulations, but they fre-i mation on preparing the backfit analysis. Section 2.0 of quendy provide guidance on methods or positions ac-NUREG!BR-0184 describes how the information re-e pta e to the NRC staff for comphance with NRC 2
quired for the backfit analysi, should be included in the regulations. Most of these P. gds are issued for public i
regulatory analysis.
comment so that licensees and the public can partici-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-ing RGD must meet the following criteria before it can vide guidance on methods for meeting a performance-be considered by the NRC office responsible for that based regulation. Performance-oriented rather than particular document.
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 partie-(such as those obtained from probabilistic risk assess-ular licensee.
j 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. Ilowever, ply with NRC regulations and the require-i the use of performance-oriented regulations will entail ments that public health and safety, the envi-developing performance criteria and methods of ronme nt, and the common de fense 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 pub'ished 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
}D P. Albson. J ll Conran. O A. T roinct, "nadhtung GuiJelmet" NU.
included in the submittal, and the format of the RI G-1409. UsNRC. July im ( opics rne be purchased from the O S Gos ernment Pontmg othce. Po Box 3 70N 2.
Washington. DC text follows that of the existing RGD as much 20402 9328 nelephone (202)512-2249), or from the National Techmcal 3,; Igjh]g informahon sersice by w nnng NTis at 5235 Port Roy al Road, spnngheld.
VA 22161.Copics arc as ailable for mspeshon or coppng lor a fce from the Submittals recommendinS chances to an existing N RC I ubhc Document Room at 2120 l street $%, Wash ngton. DC. the PDR's maihng adJrcss n Mad stop l.l.-6 Washington. DC 20555, tele.
RGD will be considered by the NRC of fice responsible phone (202)634 3273. fat (202p6341341-for that document. The responsible NRC office must isce sarciy Goas foohe operanons o Nuacar Poacr Pianis. Pohn we.
first determine w hether the submittal meets the criteria s
ment." August 4.1986(5 I I R 28044). anorrected and repubbshed on Au.
gusi 2i. i9s6 (5i t R aoo2m 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.
A NRC offices are as follows.
V)
Standard Review Plans-Issuing office
{
l i
Regulatory Guides-Office of Nuclear Regu-
=
latory Research
\\Vithin a reasonable time after a proposal to change I
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 l
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 hole or in part, with respect to clear Material Safety and Safeguards for pro-the proposal, and the reason for the decision.
1 posah, related to activities involving safety, quality, approval, and inspection of the use and D. IMPLEMENTATION handling oflicensed nuclear and other radioac-TN mow of Gis wetion is to provide informa-tive materials; nuclear fuel fabrication and fuel tion to licensees, applicants, and the public regarding development; medical, industrial, academic' the NRC staff's plans for using this regulatory guide.
and commercial uses of radioactive isotopes; 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 oflow level and high level radio-10 CFR 2.802 and of changes to regulatory guidance active waste; international safeguards and documents.
t e
b i Q ))
10.12 - 9
IAEGULATOltY 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.13ecause 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.
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