ML20199F690
| ML20199F690 | |
| Person / Time | |
|---|---|
| Issue date: | 12/21/1998 |
| From: | NRC (Affiliation Not Assigned) |
| To: | NRC (Affiliation Not Assigned) |
| References | |
| NUDOCS 9901220015 | |
| Download: ML20199F690 (9) | |
Text
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. OFFICE OFNUCLEAR R ACTOR REGULATION
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i Office Letter Transmittal TO: All NRR Employees >
SUBJECT:
NRR OFFICE LETTER NO. 803, REVISION 2,
- LICENSE AMENDMENT REVIEW PROCEDURES
- i PURPOSE: NRR Office Letter No. 803, Rev. 2, supersedes NRR Office Letter No. 803, Rev.1 " TECHNICAL SPECIFICATION REVIEW PROCESS," dated February 27,1996. This office letter and its attachment establish procedures for processing license amendments for plants with an operating license. Revisions were incorporated to ensure staff requests for additionalinformation add value to the Ibense amendment process and to reflect changes in performance measures.
- DIVISION OF ORIGIN
- Division of Reactor Projects CONTACTS: William Reckley,415-1323 Sheri Peterson,415-1193 DATE APPROVED: December ,1998 AVAILABILITY: Roberta ingram,415-1219 2 Distribution:
E Central Files "
Ringram (original + 5) 9 E
o t R Concurrees DOCUMENT NAME: A:\OL803rev.wpd
- See previous concurrence E ,
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, OmCE TA:ADT TA:DRPW Tech Editor DD:DRPM _ N PD E ADT NAME *SPeterson *WReckley '
- RSanders *Dmatthews *WDean ABWSheron DATE 12/14 S 8 12/15/98 12/9 /91 12/18/98 12/16S 8 12/1768 omCE ADPR DD:NRR D 'RR l NAME *BBoger RPZimmerman DATE 12/lg/98 12/ /98 12/l>98 ,
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9901220015 991221 'T ' '
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OFFICE OF NUCLEAR REACTOR REGULATION 4
i Office Letter Transmittal
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4 TO: All NRR Employees
SUBJECT:
NRR OFFICE LETTER NO. 803, REVISION 2, " LICENSE AMENDMENT REVIEW PROCEDURES" PURPOSE: NRR Office Letter No. 803, Rev. 2, supersedes NRR Office Letter No. 803, Revision 1, " TECHNICAL SPECIFICATION REVIEW PROCEDURES," dated February 27,1996. This office letter and its attachment establish procedures for processing license l amendments for plants with an operating license. Revisions were incorporated to ensure staff requests for additionalinformation add value to the license amendment process and to reflect changes in performance measures. ,
I DIVISION OF ORIGIN: Division of Reactor Projects '
CONTACTS: William Reckley,415-1323 Sheri Peterson,415-1193 DATE APPROVED: December ,1998 AVAILABILITY: Roberta Ingram,415-1219 l
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NRR OFFICE LETTER NO. 803, REV. 2 LICENSE AMENDMENT REVIEW PROCEDURES POLICY -
j Section 182a of the Atomic Energy Act (the "Act") requires applicants for nuclear power plant operating licenses to state technical specifications (TSs) to be included as part of the license. The Commission's regulatory requirements related to the content of TSs are stated in 10 CFR 50.36, " Technical specifications." Regulatory requirements related to the amendment of operating licenses, including the appended TSs, are contained in 10 CFR 50.90, " Application for amendment of license or construction
- permit"; 10 CFR 50.91, " Notice for public comment; State consultation"; and 10 CFR 50.92, " Issuance of amendment."
OBJECTIVES This office letter, along with the attached document, provides all staff in the U.S.
Nuclear Regulatory Commission's (NRC's) Office of Nuclear Reactor Regulation (NRR) a basic framework for processing license amendment applications.
These procedures should enhance NRR's efficiency in responding to the needs of both the licensees and the public. Specific objectives include the following:
- Ensure the public health and safety are maintainpd
- Reduce inconsistency in processing of license amendments l
- Improve intemal and extemal communications i
e increase technical consistency for similar licensing actions
- Reduce delays in the issuance of license amendments (meet licensing action ;
timeliness goals of 95%<1 year old and 100%<2 years old)
- Ensure that staff RAls are adding value to the regulatory process
- Provide NRR staff with an improved framework for processing license amendment applications.
The attached " Guide for Processing License Amendments" provides a general description of the process.
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RESPONSIBILITIES AND AUTHORITIES All NRR staff who support the license amendment process are responsible for reading, !
understanding, and applying the guidance contained in the attached " Guide for l
Processing License Amendments." They also are responsible for identifying possible ;
, improvements to the guidance and submitting suggestions for such improvements to '
their management or to the assigned contacts for this office letter.
The following describes these responsibilities in greater detail.
LICENSE AMENDMENTS FOR OPERATING REACTORS The sections that follow describe specific responsibilities and authorities for each subprocess in processing a license amendment request.
A. PREPARATION OF THE WORK PLAN Reactor Projects Divisions and Division of Reactor Proaram Manaaement 4
Project managers (PMs) are responsible for the general oversight and coordination of NRR activities related to processing license amendments. They are responsible for the following specific activities in preparing a work plan:
- Obtain a Technical Assignment Control (TAC) number for the amendment to ensure fee recovery and allow tracking using the Workload Information and Scheduling Program (WISP).
Review the amendment request for completeness and acceptability.
- Perform the initial search for precedent licensing actions.
- Develop an initial amendment work plan, including scope of review, resources required, and schedule. -
e Coordinate the initial work plan, as necessary, with the technical branches.
Licensing assistants (LAs) shall help PMs perform the activities listed above.
Project directors (PDs) and other managers shall help in the development and approval of work plans, as requested by PMs, to ensure effective allocation of resources, responsiveness to licensees' requests, adherence to timeliness goals and pe formance measures, and quality work.
Staff responsible for Standard Technical Specifications (STSs) shall respond to questions from PMs regarding the relevance of STSs to the amendment request.
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. i i Technical Divisions / Branches 1
) Staff from the technical branches shall work with PMs, as requested, to ensure l that the amendment processing plan is complete and the scope, resources, and i schedule are sufficient to perform the required safety review.
Branch chiefs and other managers shall help in the development and approval of j work plans, as requested by technical staff, to ensure effective allocation of l resources, minimal changing of staff reviewers midstream (when necessary, ;
j minimal impacts are encountered), responsiveness to licensees' requirements, !
i adherence to timeliness goals and performance measures, and quality work. i t
j B. PUBLIC NOTIFICATION AND COMMENT RESOLUTION
- i Reactor Proiects Divisions and Division of Reactor Proaram Manaoement Project managers are responsible for the following activities regarding any i required public notifications
e Prepare and submit the first public notification. This includes the following actions:
j - reviewing the licensee's analysis of no significant hazards consideration issues and determining its adequacy for use in the public notification >
f l - reviewing the proposed amendment, implementation dates, and other j information and determining what type of public notification is required j - preparing the notification for submittal to the FederalRegister l e Resolve any public comment.
j e Coordinate NRR activities related to the hearing process.
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- Prepare and submit any additional public notifications, including those due '
! to licensee changes in the amendment request and the final notification of l
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- amendment approval, denial, or withdrawal. l l Licensing assistants shall help PMs coordinate the publication of notices related to license amendments.
I j Technical Divisions / Branches
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- If asked by the PM, personnel from the technical branches shall assist in
! evaluating the licensee's ana!ysis of issues related to no significant hazards i considerations, preparing the Federa/ Register notification, resolving public '
] comments, and participating in the hearing process.
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C. PREPARATION OF THE SAFETY EVALUATION Reactor Projects Divisions and Division of Reactor Proaram Manaaement l
Project managers are responsible for the following in preparing the safety ;
evaluation (SE): 1 e Determine, with assistance from technical branch personnel as required, who will pedorm the safety review (the PM or technical branch staff).
- Pedorm the safety review, when appropriate.
- Coordinate assistance from technical branch personnel, as required.
- Coordinate with technical branch personnel if scope, resoumes, or due dates need to be changed for any reason.
- Ensure that the regulatory basis and framework are clearly articulated in the SE.
Technical Divisions / Branches Staff from the technical branches are responsible for the following in preparing the safety evaluation:
- Assist the PM in determining who should perform the safety review.
e Provide informal guidance to the PMs on the safety review, if asked.
- Perform safety evaluations, when appropriate, within scope, resources, and time limits negotiated with the PM.
- Coordinate with the PM if scope, resources, or due dates need to be changed for any reason.
- Ensure that the regulatory basis and framework are clearly articulated in the SE.
NRR Manacement Division of Reactor Projects (DRP), Division of Reactor Program Management (DRPM) and technical branch management shall resolve any disagreements between PMs and technical staff regarding the scope, depth, resources, and deadlines for safety reviews.
5 D. REVIEW AND CONCURRENCE OF THE AMENDMENT PACKAGE Reactor Projects Divisions and Division of Reactor Proaram Manaaement Project managers are responsible for the following activities regarding review and concurrence:
e Ensure that the review and concurrence chain includes all of the individuals responsible for the quality of the amendment.
e Track the status of the amendment package as it moves through the review and concurrence process.
Licensing assistants shall review the amendment package and ensure that it is complete and correct.
The Office of the General Counsel (OGC) shall review all amendment packages for legal adequacy and defensibility, unless a memorandum of agreement is developed stating that specific amendments do not require OGC concurrence.
Staff responsible for STSs shall review and concur, as requested by the PM, on amendment packages where the fullowing is noted:
- 1. There are significant deviations from the improved or original STSs.
- 2. The package is related to the relocation of TS requirements based on the criteria incorporated into 10 CFR 50.36.
Technical Divisions / Branches Staff from the technical branches are responsible for the following activities:
Review and concur on amendment packages if the SE was not prepared by technical branch staff (except when concurrence authority has been given to PMs or lead PMs for multi-plant actions).
Review and concur on amendment packages if the SE was prepared by technical branch staff when the PM has made substantial changes.
- Review and concur in a timely manner, consistent with the amendment implementation schedule and NRC concurrence policies.
E. PREPARATION AND ISSUANCE OF THE AMENDMENT Reactor P_rojects Divisions and Division of Reactor Proaram Manaaement Project managers and LAs shall coordinate and perform those activities related
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6 to issuing the approval or denial of license amendments.
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BASIC REQUIREMENTS The attached guidance describes a procedure for processing amendments to operating licenses requested by licensees. The process comprises the following subprocesses:
e work plan preparation, which provides guidance for planning the license amendment action, including obtaining a Technical Assignment Control (TAC) number, reviewing the application for completeness, searching for precedent license actions, identifying technical issues, determining technical complexity, developing estimates of resources required, and coordinating activities of various ;
personnel involved in reviewing and issuing the amendment i
e public notification and comment resolution, which provides guidance on procedures for the public notification of license amendment actions i
e safety evaluation preparation which provides guidance for the planning and conduct of the safety review and the preparation of the safety evaluation e review and concurrence which provides guidance for the concurrence process by which the quality of the amendment package is assured e amendment preparation and issuance which provides guidance on the final issuance of the amendment 9
EFFECT VE DATJ This office letter is effective immediately.
REFERENCES
- 1. 10 CFR 50.36, " Technical specifications'
- 2. 10 CFR 50.90, " Application for amendment of license or construction permit'
- 3. 10 CFR 50.91, ' Notice for public comment; State consultation"
- 4. 10 CFR 50.92, ' Issuance of amendment' 4
ATTACHMENT Guide for Processing License Amendments, December 1998 cc: W. Travers, EDO F. Miraglia, DEDR SECY RES H. Miller, RI L.Reyes,Ril HR PUBLIC J. Dyer, Rlli E. Merschoff, RIV OGC(5) NMSS
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to issuing the approval or denial of license amendments.
BASIC REQUIREMENTS The attached guidance describes a procedure for processing amendments to operating licenses requested by licensees. The process comprises the following subprocesses:
- work plan preparation, which provides guidance for planning the license amendment action, including obtaining a Technical Assignment Control (TAC) number, reviewing the application for completeness, searching for precedent license actions, identifying technical issues, determining technical complexity, developing estimates of resources required, and coordinating activities of various personnel involved in reviewing and issuing the amendment e public notification and comment resolution, which provides guidance on procedures for the public notification of license amendment actions e safety evaluation preparation which provides guidance for the planning and conduct of the safety review and the preparation of the safety evaluation e review and concurrence which provides guidance for the concurrence process by which the quality of the amendment package is assured e amendment preparation and issuance which provides guidance on the final issuance of the amendment EFFECTIVE DATE This office letter is effective immediately.
REFERENCES
- 1. 10 CFR 50.36, " Technical specifications"
- 2. 13 CFR 50.90, " Application for amendment of license or construction permit"
- 3. 10 CFR 50.91, " Notice for public comment; State consultation"
- 4. 10 CFR 50.92," Issuance of amendment" ATTACHMENT Guide for Processing L; cense Amendments, December 1998 cc: W. Travers, EDO F. Miraglia, DEDR SECY RES H. Miller, RI L. Reyes, Rll HR PUBLIC J. Dyer, Rill E. Merschoff, RIV OGC(5) NMSS
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United States Nuclear Regulatory Commission Guide for Processing License Amendments Office of Nuclear Reactor Regulation
, Revised December 1998 WW 6 ?l/ YYW .
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e Contents 4 i l
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i A bbre vi ati on s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv J L 1.0 Introdu cti on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.1 i
l 1.1 Obj ecti v es . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.1 1.2 Proce s s Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.1 4 ,
' t 2.0 Work Pl ann in g . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1 i
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] 2.1 Obtain TAC Numbe r . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1 i L 2.2 Review Application for Completeness and Acceptability . . . . . . . . . . . . . . . . . . . . . . . . . 2.3 i
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l 2.3 Search for Precedent Licensing Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.4 .
I 2.4 De velop a Work Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... .. ......... ...... 2.5 i 2.4.1 Scope and Depth of Review . . . . . . . . . . . . . . . . . ... . .................. 2.8 4
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P 2.4.2 Resources To Be Used in the Review . . . . . . . . . .. . ............... 2.9 i
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E i 2.4.3 Schedule of Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . , . ............... 2.11 !
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2.4.4 Sc hedule Re visions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.15 !
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2.5 Work R eq u e st Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.15 3.0 Public Notificati on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1 i 3.1 Normal (30-Day) Public Notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1 t
3.2 Emergency Public Notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2 !
3.3 Exigent (15-Day) Public Notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3 ,
3.4 Exigent Local Notifiestion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3 I
Guide for Processing License Amendments Page i ,
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- 4. 0 S afety Evalu ation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1 ,
4.1 Evaluation Planning and Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1 1
4.1.1 PM Re vie w . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1 4.1.2 Technical Staff Review . ............................................. 4.2 4.1.3 Contractor Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.2 4.2 Use of Precedent Safety Evaluations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.3 4.3 Requests for Additional Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.3 l 4.4 Regulatory Commitments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.4 j 4.5 Safety Evaluation Format . ........... ... .. ............................. 4.6 l l
4.5.1 Introduction ........... . . ................ ................ .. . 4.6 '
4.5.2 Background . . . . . . . . . . . . . . . .
.......... .......... ........ ... 4.6 l 4.5.3 Evaluation . . . . . . . . . . . . . . . . ... .. ......................... 4.7 4.5.4 Other . . . . . . . . . .. . . . .. ... ................... .. 4.7 5.0 Review and Concurrence . . . . . . . . . . . . . . ........ ........................ ... 5.1 6.0 Amendment Preparation and Issuance . . . . .. . . .............................. . 6.1 Attachment 1 - Work Request Form and Instructions ............................. .....A.1-1 Attachment 2 - Safety Evaluation Form and Content Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A.2- 1 I r
Attachment 3 - Amendment Routing Form ...........................................A.31 4
$ i Page ii Guide for Processing License Amendments
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j Figures 1
4 I Work Process Flow for License Amendment Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.3 2 License Amendment Work Planning Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2 l i
j 3 PM's Guidance for Amendment Package Review and Concurrence . . . . . . . . . . . . . . . . . . . . . 2.8 j
i 4 Planning Strategy Guidance for Levels of Application. Precedent Similarity and Review i Tec h nical Comple x ity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.2 4
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! Tables 1
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- 1 Technical Complexity and Risk Significance .............. ...... ... . .... . 2.7 3 2 Guidance for Estimating Application Review Hours of Effort ... . ... .... ...... . 2.11 3 Licensing Action Timeliness Goals . . . . . . . . . . . . . . . . . . . . . . . . . . . ...... ..... 2.12 j 4 Routine and Maximum Amendment Completion Times ...... ..... . ... .. ... 2.14 J
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Guide for Processing License Amendments Page lii l
Abbreviations ADM Office of Administration ADT Associate Director for Technical Assessment CBLA Cost Beneficial Licensing Action CFR Code ofFederalRegulations DISP Division ofInspection and Support Programs DSSA Division of Systems Safety and Analysis DRP Division of Reactor Projects EA Environmental Assessment FR FederalRegister LA Licensing Assistant LAN Local Area Network NRC Nuclear Regulatory Commission NRR Office of Nuclear Reactor Regulation NSHC no significant hazards consideration NSHCD no significant hazards consideration determination O&A Oath and Affirmation OGC Office of the General Counsel OL Office Letter PD Project Director or Project Directorate PDR public document room Page iv Guide for Processing License Amendments I
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PGEB Generic Issues and Environmental Projects Branch g.
N' PM Project Manager RAI request for additionalinformation RILA risk-informed licensing action SE safety evaluation SECY Office of the Secretary of the Commission '
SPSB Probabilistic Safety A:sessment Branch SRP Standard Revjew Plan cRP/TRS Standard Review Plan / Text Ret:ieval System 9TS Standard Technical Specifications TAC technical assignment control TB Technical Brsnch TS Technical Specifications TSB Technical Specifications Branch UFSAR Updated Final Safety Analysis Repon i
WISP Workload Information and Scheduling Program Guide for Processing License Amendments Page v
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1.0 Introduction His guide provides staff in the U.S. Nuclear Regulatory Commission's (NRC's) Office of Nuclear Reac-tor Regulation (NRR) with a basic framework for processing license amendment applications m . The guide is for use by Project Directors (PDs), Project Managers (PMs), Licensing Assistants (LAs), and their management; as well as Technical Branch (TB) staff and management. This guide provides a general description of the process that is expected to be followed. However, it is recognized that amendments are reviewed and issued under various conditions that require flexibility in the planning and execution of application reviews. This guide is intended to allow that necessary measure of flexibility.
1.1 Objectives 1
The objective of this guide is to help NRR enhance its efficiency in responding to the needs of both the licensees and the public. Specific objectives include the following
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ensure the publi: health and safety are maintained !
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reduce inconsistency in processing oflicense amendments
+ improve internal and external communications increase technical consi:.tency for similar licensing actions a
reduce delays in the issuance of license amendments (e.g., in FYOO and beyond meet licensing action completion timeliness goals of 95%<1 year old and 100%<2 years old) l ensure that staff RAls add value to the regulatory process !
+ provide NRR staff with an improved framework for processing license amendment applications.
1.2 Process Overview 4
The approval or denial of license amendment applications is part of a continuous process of managing issues related to nuclear power facilities. The review of license amendment applications is one of the primary mechanisms for regulating changes in the licensees' operation. of their facility. Project Managers, Technical Branch staff and licensees should be in regular contact to discuss NRC's ongoing 4
} (1) Although some guidance in this document may be relevant to the processing of conversions to the improved Standard Technical Specifications and for the renewal of operating licenses in accordance with 10 CFR Part 54, separate processes and staff guidance govern the disposition of these types oflicensing actions (see OL 805 for license renewal).
Guide for Processing License Amendments Page1.1
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reviews and other regulatory matters requiring NRC review and approval. Frequent and early communications between the staff and the licensee can help avoid unnecessary delays in the processing oflicense applications.
The PM's role in the license amendment process is to manage the NRC's review of the application, either by performing the review or by overseeing the review performed by other NRC staff. The PM ensures that these guidelines associated with Office Letter (OL) 803, Rev. 2, " License Amendment Review Procedures," and the principles of good regulation are adhered to throughout the process. Project Managers and Technical Branch staff are jointly responsible for ensuring that NRR meets the goals established in operating and performance p;.ms. The process employed for amendment request applications can be characterized by the subprocesses in Figure 1:
work planning
. publi 5.otification and comment resolution
. evaluation of proposed amendment i
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. document conclusion in safety evaluation
. amendment preparation l
. review and concurrence amendment issuance Each of these subprocesses is described in more detail in the following chapters. Chapter 2.0 discusses the work planning process, Chapter 3.0 discusses the public notification process, Chapter 4.0 discusses the safety evaluation (SE) process, Chapter 5.0 discusses the review and concurrence process, and Chapter 6.0 discusses the amendment preparation and issuance process.
NRR staff involved in processing license amendments should identify any possible improvements to this guidance and submit suggestions to their management or the contacts listed for OL 803.
Page1.2 Guide for Processing Liense Amendments l
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l Amendment Application V i 1 r Work Planning "M '
initial Environmental - Public Consideration Notdeation 1 r 1 r Safety , Pubhc Evaluaton - Comment Resolution 1 r Amendment Preparation 1 r Rev ew and Concurrence
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Pubhc Notdcation of lasuance 1
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Amendment Figure 1. Work Process Flow for License Amendment Requests l
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2.0 Work Planning Planning the processing of an amendment application is a critical step in ensuring that the work is com-pleted in a timely and effective manner. As in most planning activities, the basic questions to be addressed are Who?, What?, Where? and When? This section describes a series of five steps that should 1 be addressed by PMs in developing an amendment review work plan. I 1
Figure 2 provides an overview of the five steps in planning to process an amendment application. These steps are:
- 1. Obtain a technical assignment control (TAC) number through the workload information and schedul-ing program (WISP). This provides a means of billing the licensee and tracking the work.
- 2. Typically within a week after receipt of the application, review the application to ensure that it contains all required information. The PM may involve the technical branches in this initial review of the application based on its technical complexity (refer to Section 2.2). If the application is not I complete or acceptable, the PM should attempt to resolve the problem (s). If the issues cannot be l resolved, the PM should notify the licensee regarding amendment application deficiencies or the I possible withdrawal of the application. The staff may also issue a notice of denial if the licensee does not correct the application within a reasonable time (typically 60 days). l
- 3. The staff should identify, assess, and review information about precedents set by similarlicensing :
actions, after determining that an application is complete (i.e., sufficient to initiate a formal staff review),. !
- 4. Review the amendment and related information in sufficient detail to develop a work plan that defines the scope, depth, resources, and schedule of the remaining work.
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- 5. If TB review is requested, prepare a work request form to achieve and document a mutually agreed- !
upon work plan. The PM should ensure that key elements of the work plan are captured in the WISP l
system.
The remainder of this chapter provides guidance concerning the performance of each of these five plan-ning activities. During periodic calls with the licensee, the PM should provide feedback to the licensee on the status of license amendment processing activities for the licensee's applications (such as on the results of the priority determination, acceptance review, work plan and technical review). Figure 2 also includes a step related to performing the required environmental assessment of the proposed license amendment. Additional information related to the staff's responsibilities for environmental assessments is, contained in OL 906.
2.1 Obtain TAC Number Technical assignment control numbers are used to categorize work and determine fee recovery. The Guide for Processing License Amendments Page 2.1 l l
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Obtain TAC Number i r
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Review Apphcation 1 r Co ete No No
, issues Retum to Acceptable Resolved Licensee 7
Yes 1 r' Yes EA re Required PrdA '
No :
1r 3.
Search for Precedents 1 r 4.
Develop Work Plan 5
Update Amendment Tracking Form Figure 2. License Amendment Work Planning Process Division ofInspection and Support Programs (DISP) within NRR routinely issues guidance for obtaining TAC numbers. Procedures and responsibilities for obtaining TAC numbers through WISP are detailed in the "NRR Office Workload Procedures Manual" attached to OL 303. When obtaining the TAC number, the PM establishes the priority and schedule of review for the amendment application (see Section 2.4.3).
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2.2 Review Application for Completeness and Acceptability l
After the PM requests a TAC number and typically within a week following receipt of the application, the task of reviewing the amendment application for completeness should begin with help from an LA.
The PM may involve the technical branches in this initial review of the application based on its technical complexity. The minimal requirements for applications are described in 10 CFR 50.30,50.90,50.91, 50.92, and 51.22. The following guidance highlights imponant key elements that should normally be contained in a license amendment application. It is provided to assist PMs in their initial screening process. The guidance is not an interpretation or a substitute for conforming with the legal requirements of the regulations, nor does the guidance itself constitute an absolute requirement. The key elements in an amendment application are listed below:
+
oath and affirmation (O&A)
+
description of the amendment (including discussions on the content of the currentlicense condition or technical specification, the proposed change and why the change is being requested, how it relates to plant equipment and/or operating procedures, whether it is a temporary or permanent change, and the effect of the change on the purpose of the technical specification or license condition involved.)
+
licensee's safety analysis / justification for the proposed change (The application should specify the current licensing basis that is pertinent to the change (e.g., codes, standards, regulatory guides, or Standard Review Plan (SRP) sections). The safety analysis that supports the change requested should include technical information in sufficient detail to enable the NRC staff to make an independent assessment regarding the acceptability of the proposal in terms of regulatory requirements and the protection of public health and safety. It should contain a discussion of the analytical methods used, including the key input parameters used in support of the proposed change. The discussion also should state whether the methods are different from those previously used and whether the methods have been previously reviewed and approved by the staff.)
no significant hazards consideration determination (50.92) requested review schedule and/or implementation period appropriate technical specification (TS) pages a
environmental assessment (51.22) copy to appropriate State If a licensee's amendment application does not include one or more of the preceding items, the PM should contact the licensee and arrange for the information to be submitted. Under these circumstances, Guide for Processing 1.icense Amendments Page 23
!' i A
the licensee may withdraw the request or may correct the deficiencies within a mutually agreed upon
- time. If the licensee does not correct the deficiencies within the specified time, the amendment may be j
denied. If an application is withdrawn or denied due to a deficiency in the submittal (as opposed to a i definitive, negative finding by the staff based on the technical merits of the proposed changes), then a licensee may submit a new application (with the identified discrepancies corrected) at any time in the j future.
The PM should also perform a preliminary assessment to determine the subject and scope of the licensee'sproposed amendment. This assessment is necessary for the subsequent steps in this guide and should also provide an initial position regarding the reasonableness of the proposed changes and the ade-quacy of the licensee's no significant hazards consideration determination (NSHCD). If, based upon this review, the staff finds the licensee's NSHCD to be inadequate, the PM may either prepare a staff determination for publication in the Federal Register or may request that the licensee supplement the original submittal. If a proposed change does not satisfy the criteria for publication of a proposed NSHCD, an individual notice allowing an opponunity for a prior hearing must be published (see Section 3.0).
The PM should detennine if the licensee's submittal includes any proprietary information. The PM is responsible for the review of the material requested to be withheld from the public in order to ensure that the information satisfies the criteria of 10 CFR 2.790. Project Managers may find additional guidance pertaining to proprietary information in OL 602, Procedure for Handling Requests to Withhold Proprietary Information," and may also get assistance in making this determination from LAs, TB staff, and OGC.
2.3 Search for Precedent Licensing Actions Searching for, identifying, and using precedents in the review process maximizes staff efficiency, ;
minimizes the need to issue requests for additional information and ensures consistency of licensing actions. Precedent licensing actions are those with a similar proposed change and regulatory basis for the SE. The search for a precedent should continue until NRR staff are satisfied that either 1) they have identified one or more appropriate precedents or 2) O at no appropriate precedents' exist. Project Managers have the primary responsibility for conducting a precedent search but can be assisted by TB staff familiar with specific technical areas. The follow ing racchanisms may be employed in conducting a precedent search. Staff should consult with their colleagues or managers to obtain training or guidance if they are unfamiliar with the use of any of these mechanisms.
Licensees - Licensees and their contractors have developed systems to identify precedent amend-ments and often share information related to requests and the staff's evaluation. Some licensees include such information in the submittal while others will provide the information informally fol-lowing a request by the PM.
Staff Input - Discussion with other PMs and TB staff is frequently useful in identifying precedents.
If necessary, PMs should consult the Generic issues and Environmental Projects Branch (PGEB) about environmental issues (see OL 906).
PaFe 2.4 Guide for Processing L.icense Amendments l
l ,
1 4
Staff Guidance - Guidance issued by lead PMs and TB staff may include model safety evaluations for some classes of amendments. Examples include the guidance related to the relocation of TS j
requirements to the Updated Final Safety Analysis Report (UFSAR) and generic letters that provide line item improvements.
Internal NRC Home Page (http://nrrIO.nrc. gov / projects /sersrch.htm) . This software application l can be used to search for safety evaluations related to the subject (s) of the amendment request.
Safety evaluations dating from 1990 to the present are being entered into the set of searchable safety evaluations.
i i NUDOCS - This software application can be used to search for amendments similar to the one being i processed. The NRC records can be searched, including searches that select records by specifying a
document types, such as licenses and amendments (TLLOLL) or safety evaluations (TRSER), and then narrowing the population using key words or phrases.
WISP - This software application can be used to identify precedent licensing actions with compara-ble titles. To perform the search, select " Global Reporting" and choose, " Search Task Title" The search allows searching for words or combinations of words used in TAC titles.
Standard Technical Specifications (STSs) - A comparison of the amendment request with appro-priate sections of the corresponding improved STS may result in the identification of current policy pertinent to the amendment request being processed. If the licensee is proposing a change that is modeled after the STS, the expanded bases sections of the STS will often contain discussion that will j aid in preparing a safety evaluation.
Federal Register Notices - The biweekly collection of proposed and issued amendment notices in the Federal Register can be scanned to search for similar amendment requests.
In general, preference should be given to the most recent precedents identified. Additional considerations for the use of precedents is provided in Section 4.2. Discussions with the appropriate TB(s) may help determine the appropriate precedent to use for a specific amendment review.
If one or more appropriate precedents are identified, the PM should note if an Environmental Assessment (EA) was necessary for the amendment or if the precedents referenced a categorical exclusion. If no precedent exists the PM should determine if an EA is necessary. Actions that are categorically excluded are identified in 10 CFR 51.22. Additional guidance related to environmental assessments is provided in OL 906.
t 2.4 Develop a Work Plan Following the preliminary assessment and search for precedent actions, the necessary information should be available to develop a detailed plan for processing the amendment application. This plan is intended to define the scope and depth of the review, resources needed for the review, and the schedule for completion of the review.
Guide for Processing 1.icense Amendments PaFe 2.5
/ .
If the PM is going to prepare the safety evaluation, TB staff would be consulted regarding this plan. If TB staff will be preparing the safety evaluation, or if there are substantial hours of technical staff time involved, the TB staff should be involved in preparing the work plan. The level of interaction between the PM and TB staff is, generally, determined on the basis of 1) the similarity between the application 4
and precedent licensing actions and 2) the risk significance of the amendment request and 3) the i
technical complexity of the required review.
The similarity between an application and precedent can, for the current purposes, be categorized into 1 three levels:
No or Low Similarity - There is either no precedent to apply, or major modification to the precedent license amendment would be required for use for the application under consideration.
l l
Medium Similarity - The review of the application could apply a precedent with limited technical modifications.
High Similarity - The review of the application could directly apply a precedent without technical modifications.
The technical complexity of a required review can also be categorized into three levels:
1 Low Complexity - includes changes to position titles in the TS administrative controls section and I simple changes to setpoints or other TS details.
)
Medium Complexity - includes extensions of allowed outage times or surveillance test intervals, alternate action statements, reload related changes, or other changes that do not involve major changes or review of established NRC policies.
High Complexity - includes power rerates, significant restructuring of TS, changes that introduce significantly different analytical methodologies, and changes that are related to revising established NRC policies.
Consideration of risk insights, when provided by the licensee, should also be incorporated into the development of the work plan for the processing oflicense amendment applications. For the purpose of this office letter, risk insights should be addressed in a manner similar to the technical complexity discussed above. In general, the te:hnical complexity categories correlate to the following risk significance categories defined in a memorandum to the staff from Gary Holahan, Director, Division of Systems Safety and Analysis, dated October 30,1998, " Interim Guidance on Implementation of Risk-Informed Review Processes."
l Page 2.6 Guide for Processing License Amendments
l ,
Table 1. Technical Complexity and Risk Signincance Technical Complexity Risk Significance (10/30/98 Memo)
Low Very Low Risk Significance Medium Low to Moderate Risk Significance High Substantial Risk Significance ,
1 Figure 3 provides a summary of the planning strategy that is generally applicable for alternative levels of ;
these combined factors. This figure illustrates that three general strategies should be adopted, as summa- 1 rized below.
PM Develops Work Plan and Informs Technical Staff - When precedents can be readily applied and the risk significance and technical complexity are relatively low, the PM should prepare a plan and proceed with the review. Technical staff should be informed (informal communication such as E mail is acceptable) of the PM's intent. The PM should identify the precedent being utilized to ensure that the TB understands the approach and acceptance criteria. The TB may suggest alternate precedents or identify key issues that need to be addressed in the SE.
PM Drafts Work Plan for Discussion with Technical Staff - When the PM intends to perform the review and has a general understanding of how to proceed, but requires some input from a TB to develop the plan, the PM should draft an initial plan and obtain an informal review of the plan by the TB. When TB review is being requested, a work request can be prepared and submitted to the TB without significant prior discussions. Details regarding the scope and depth of the review, resources, and schedule can be negotiated in the context of completing the work request form.
PM and Technical Staff Meet to Draft Work Plan - When precedents are not readily applied and the risk significance and/or technical complexity are relatively high, the PM should prepare an information package for technical staff and convene a meeting to review issues and draft a review plan prior to submitting work request forms. Involving licensees in inectings or conference calls before or soon after submittals may be useful for amendment applications that involve complex technical issues or policy changes for the NRC.
Guide for Processing License Amendments Page 2.7
4 4
Technical Similanty Between Apphcation and Precedent Complexy Low Medium Hsh
)
j T l Low J -
TechnicalStaff i l
PM Draft Work Plan for Discussion Medium with Technical )
i ....
High Stat! Meet to Draft Wo'k Plan :
1 Figure 3. PM's Guidance for Amendment Package Review and Concurrence
)
Regardless of the strategy used to draft an amendment request work plan, the scope and depth, resources, and schedule must be defined. When there are TB resources involved in the preparation of the SE, the designated supervisor will review the workplan and must concur with the estimates of scope and depth, resources, and schedule based upon the risk significance and technical complexity of the amendment request. s PMs should give special attention to those reviews that involve multiple TB or PM reviewers. The work plans for such amendment requests need to ensure that the scope and schedule for each reviewer are well defined and understood. Multiple work requests may be necessary for such reviews. Each work request should clea.rly define the work plan for the associated TB and include a listing of o'.her tbs that will provide input or be asked to concur. Disagreements, if not resolved by the PM and ;echnical staff, will be elevated to NRR management. Following are discussions of these three cdmponents of the plan.
2.4.1 Scope and Depth of Review I
The technical review of the amendment application will, in most cases, represent the bulk of the tech-nical effort that will be expended in processing an amendment. The appropriate Standard Review Plan Page 2.8 Guide for Processing License Amendments
__._._.._____....__._______.___...m____ _.
i I i j (SRP) section and the licensee's UFSAR and other docketed correspondence that form the licensing basis .
for the facility, as well as the relative risk significance of the licensee's request, should be used as l guidance in determining the scope and depth of the review. Thus, careful identification of what will be addressed in this review is central to effective planning. A complete statement of scope and depth should I
! either identify the following or should include identification of these items as part of the review:
s
} e the regulatory basis for the amendment request t
e the plant specific licensing bases including regulatory requirements and commitments upon which i the subject technical specifications were originally developed l \
! e the design, operating, and maintenance related safety concerns that will be addressed by the review
} -
l l e any previous licensing amendments that will serve as a modelin conducting the review i
- e all appropriate TB reviews required i
l e the data or information required to conduct the evaluation.
i e the relative risk significance of the amendment request (very low risk significance, low to moderate
[
j risk significance and substantial risk significance).
+
{ A memorandum to the staff from Gary Holahan, Director, Division of Systems Safety and Analysis i (DSSA), dated October 30,1998, provides guidance for the review of applications classified as risk- ;
j informed licensing actions. A risk-informed licensinc action is defined as any licensinc action that uses ,
l auantitative or aualitative risk assessment insichts or techniaues to orovide a key comoonent of the basis
- for the accentability or unaccentability of the oroposed action. Additional information related to risk-2 informed licensing actions is also provided in Administrative Letter 98-09, " Priority for NRR Review of j Risk-informed Licensing Actions." In general, the guidance includes assignment of a high priority for ;
j staff review of risk-informed licensing actions as well as the involvement of the Probabilistic Safety :
Assessment Branch (SPSB)in the review of the applications. Project Managers or TB staff may also ,
consult SPSB staff regarding the initial judgment of risk significance and how that assessment is being
} used to develop the staff's work plan. t i
j In some cases, the technical staff may provide informal guidance and responses to information needs by j the PM in lieu of providing a formal SE. Such informal information or assistance from TB staff would f j not preclude the need for concunence by that TB on the final amendment pac,kage (see Chapter 5).
2.4.2 Resources To Be Used in the Review The primary resource expended in the review process is the time of the PM, technical staff, and contractor staff. To ensure the efficient and timely use of this resource, initial estimates of staff respon- I sibilities and hours to be expended are required. The number of hours expended should be based on the ,
i Guide for Processing License Amendments Page 2.9 l
L
a .
scope and depth of the review, which is determined by the availability of precedent reviews, the technical complexity of the proposed changes, and the risk significance of the amendment request, ( i.e. the lower the risk significance, the fewer the hours expended).
Staff Responsibilities Primary responsibility for preparation of an SE will be assigned to a PM or to technical staff. The PM would normally conduct the review and prepare the SE for those requests that are relatively low in technical complexity, relatively low in risk significance, and have relatively high similarity to precedent licensing actions (upper-right segment in Figure 3 matrix). Technical staff would normally lead the review and evaluation preparation for those requests that are relatively high in technical complexity, relatively high in risk significance, and have relatively low similarity to precedent licensing actions (lower-left segment in Figure 3 matrix). The assignment of responsibility for the remaining types of applications (center segment in Figure 3 matrix) will typically result from discussions between the PM and technical staff. The PM should ensure that all relevant tbs that may have some technical responsibility for the content of an amendment application be involved in the review. The PM is also responsible for preparing an EA if needed.
The use of contractors is determined by the technical staff based on 1) technical expertise required to perform the scope of review,2) availability of NRR technical staff to support the required review in a timely manner, and 3) availability of funds to support contractor review efforts.
Staff Ilours 4
It is often difficult to estimate the number of staff Sours required to perform a review; however, developing a reasonable estimate is critical to the development of a quality work plan. When devel-oping an estimate, the PM and TB (chief or designee) should consider the scope of the review and estimate the time required for any distinct subparts, based upon personal experience or other available sources. Best estimates of the number of hours for each NRR staff should be developed. If these estimates are going to be significantly exceeded during execution of the plan, the problem should be promptly brought to the attention of appropriate management, and revised estimates should be developed and agreed upon.
Project Managers may also use WISP to estimate required staff resources (refer to the WISP manual). Project Managers also can develop estimates of staff resource requirements for reviews using informal estimates based on personal experience about resource requirements from previous staff reviews for tasks of similar technical complexity.
Table 2 provides some general guidance for estimating the hours of effort that will be required to complete a review. This table uses the same complexity and similarity matrix used in Figure 3.
Hour ranges in Table 2 are for general guidance only. However, if other bases for developing hour estimates are not available, a particular hour estimate should fall within the guidelines provided in Table 2. In an effort to improve the incorporation of risk insights into its processes, the staff should make an initial judgment as to the scope and depth of review effort needed based on the risk Page 2.10 Guide for Processing License Amendments
significance of the specific application. If the application is of very low to no risk significance, that assessment should be reflected in the hours scheduled for reviewing the application (i.e., minimize the staff review of proposed changes with very low or no risk significance).
Table 2. Guidance for Estimating Application Review Hours of Effort Similarity Between Application and Precedent Technical Complexity and/or Risk Significance No or Low Medium High Low 10 - 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> 10 - 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> 10 - 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> Medium 40 - 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> 40 - 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> 20 - 60 hours6.944444e-4 days <br />0.0167 hours <br />9.920635e-5 weeks <br />2.283e-5 months <br /> High >120 hours >80 hours >60 hours __
2.4.3 Schedule of Review A firm date for completion of the amendment application review and preparation of the SE, consistent with the factors on the following pages,is essential to a complete work plan.
As in the preceding components of the work plan, scheduling can either be developed by the PM, drafted by the PM for discussions with the technical staff, or developed jointly through PM and technical staff consultation. Factors to be considered in the schedule determination are:
1 safety significance and agency priorities l
- licensing action timeliness goals licensee needs and desires, including implementation date a
application priority
- review resource requirements and availability
+ contractor resource requirements and availability. ,
Licensee Needs and Desires The licensee should communicate (formally or informally) a desired issuance date and include a proposed implementation period in its amendment application. The PM incorporates the requested ;
implementation period in the amendment (e.g., the amendment is effective immediately and will be '
Guide for P xessing License Amendments Page 2.11 l
,. i implemented within 30 days). This provides the licensee time to incorporate the amendment into the controlled copies of the TSs and licenses and provides an acceptable period to implement procedural or hardware changes. If possible, the schedule established by the PM should satisfy the realistic needs of the licensee. The priority system includes some consideration of licensee needs but may not adequately address this factor. If the licensee has submitted multiple amendment requests, the PM should discuss the review priorities with the licensee. The licensee can help establish the review priorities by determining cost savings, outage plans, and other factors. Efforts to meet the licensee's requests are aimed at minimizing the regulatory impact of the review process. If the licensee's requested date cannot be met due to staff resource limitations, the PM should discuss the issue with the licensee.
Licensing Action Timeliness Goals The Govemment Performance and Results Act requires Federal agencies to develop strategic plans, set performance goals, and report annually on actual performance compared to those goals. As a major element in the mission of NRR, the processing of licensing actions has several related l performance measures that will largely determine how the management and staff of NRR are judged.
The following timeliness goals have been included as performance measures for NRR to monitor the efficiency and effectiveness of the staff in completing licensing actions:
Table 3. Licensing Action Timeliness Goals Goals - Timeliness of Completing Licensing Actions as Measured by the Percentage of Incoming Requests Completed Within Goal Completed in s 1 year Completed in s 2 years Completed in s 3 years Fiscal Year 1999 280 % 295 % 100 %
Fiscal Year 2000 295 % 100 % -
and beyond in addition to the timeliness goals, NRR has performance measures for the number of licensing l
actions completed and the open inventory of licensing actions during given budget cycles. Although these performance measure may not be a factor in the development of a work plan for a specific amendment request, the staff should remain cognizant of the existence of these performance measures and may need to respond to management direction to revise schedules or priorities due to I concerns pertaining to these goals. The staff should also be cognizant of the fact that the established l performance goals include efficiency gains (" measured" by decreasing the staff resources allotted per completed licensing action).
Application Priority The current scheme used for assigning NRR review priorities was presented in a June 6,1993 memo-Page 2.12 Guide for Processing License Amendments
randum from the NRR Director *. Although the priorities still apply, the completion times for each priority category must be redefined to n eet the licensing action timeliness goals (e.g., the goal beginning in FYOO of 95% oflicensing actions completed within 1 year and 100% completed within 2 years). Several key points and examples are summarized below.
- Priority 1: High Priority - Immediate action usually required; review completion date must be met; firm commitment of resources required. Priority I efforts involve the following:
- highly risk-significant safety concerns that require firm commitment of resources
- actions needed to prevent or require plant shutdown, allow restart, or prevent significant derate
- issues for which immediate action is needed for compliance with statutory requirements, or Commission or Executive Director's Office directives.
. Priority 2: High Priority Near-Term - Short-term actions, minor changes to review completion date can be negotiated. Priority 2 efforts involve the following:
- significant safety issues that do not rise to the level of immediate action but require near-term staff evaluation
- activities needed to support continued safe plant operation, reload analyses, or evaluation of i necessary modifications or enhancements.
- risk informed licensing actions (see Administrative Letter 98-09)
)
Priority 3: Low Priority - Longer-term actions, review completion date is flexible (but still required to support timeliness goals). Priority 3 efforts involve the following:
- Cost Beneficial Licensing Actions (CBLAs) are the highest priority for this category. CBLAs are rot included in the June 1993 priority system memorandum. Background information, including the criteria for CBLAs, are defined in Administrative Letter 95-02
- issues of moderate to low safety significance that do not directly impact plant safety
- requests for technical specification amendments required for economic advantage (e.g., changes in core and equipment operating limits, limiting c~onditions for operation and surveillance requirements, deletion of equipment that is no longer used, administrative (2) Although the NRR priority system includes Priority 4 items, the staff no longer routinely classifies items as Priority 4. For the purpose of this Office Letter, Priority 4 items should be treated the same as Priority 3 items.
Guide for Processing License Amendments Page 2.13
_ _ . - . . - . . . . _ ~ - - .
i
)
i TS changes).
This guide provides the routine and maximum completion times for amendments, based on their pri-ority (Table 4). These are slightly shorter completion times than historically achieved prior to the issuance of this guidance. The goals in Table 4 reflect the timeliness goals of the performance measures beginning in Fiscal Year 2000. As the staff transitions to the revised timeliness goals, a reporting system will be developed to alert the appropriate Associate Director (s) to those licensing actions that may exceed the established timeliness goals.
For those amendments for which a highly similar precedent exists, PMs should make every effort to issue the amendments well below the routine completion times given in Table 4. For licensing actions without a precedent that have relatively low levels of risk significance and/or technical complexity, PMs can use these routine completion times as reasonable goals. Other factors may determine that an earlier goal is appropriate or that a schedule slightly longer than the routine is acceptable. However, every reasonable effort should be made to 1) support average NRR completion times that correspond to the routine values and 2) not to exceed the maximum completion times.
The memorandum of October 1,1998, from Samuel J. Collins, supplemented the memorandum dated June 6,1993 (Murley memo), by providing specific guidance for review of risk-informed licensing actions. Within the priority framework provided by the previous guidance, risk-informed licensing actions shall be assigned as Priority 2 unless the previous guidance would assign Priority I due to safety significance or the need for immediate action. This priority elevation is intended to highlight i the licensing action that uses risk assessment insights from among the routine licensing actions.
Guidance related to classification of license amendment requests as CBLAs is provided in Administrative Letter 95-02. If a licensee requests that a proposed amendment be treated as a CBLA, the PM should review the amendment to ensure that the criteria defined in the administrative
!ctter have been satisfied. If the amendment meets the criteria, the PM should appropriately classify the request as a CBLA in the WISP system and ensure that the review is expedited in accordance with that classification.
Table 4. Routine and Maximum Amendment Completion Times Routine Completion Maximum Completion Time Amendment Priority Time (Months) (Months) 1 3 6 2 6 8 3 9 12 (5% to 24)
Page 2.14 Guide for Processing License Amendments l
Resource Requirements and Availability A major factor to be considered in developing a schedule is resource availability. For PM reviews, PMs need to assess their own availability and the availability of other PMs. If licensee needs, priority, resource demands, and PM availability cannot be reconciled, the PM should discuss the matter with the PD to determine if another PM can assist. If resources are not available within the project directorate, the PD can consult other Division of Reactor Projects (DRP) managers to determine if resources are available. The DRP may also consult the appropriate TB on the availability of staff to perform the review in the time period requested. Both PMs and the designated TB supervisors must track staff commitments and availability to ensure that the work plan schedules are maintained. In addition to the resources required to perform the technical review and prepare the SE, PMs need to consider the other aspects of amendment processing. The resource requirements, availability and schedule impact associated with administrative staff, LAs, and the concurrence process need to be included in the planning and scheduling activities.
When DRP and TB personnel are negotiating details of a work plan, the relationships between resource requirements, scope and depth of review, requested product, and schedule should be considered. For example,it may be possible to meet a desired schedule by revising the requested support from the technical staff. By changing the requested product from a completed SE to informal support, DRP may be able to complete the SE and thereby limit the resource impact on the TB. The TB would continue to ensure technical adequacy via the concurrence process.
2.4.4 Schedule Revisions For reviews being performed by a TB, changes in the safety evaluation completion date or estimated staff hours need to be negotiated between the PM and TB designee. Requests for additionalinformation (RAls) should be prepared such that a licensee can respond and the initially agreed upon schedule can be maintained. However, the timeliness of a licensee to respond to RAls may occasionally impact the schedule and require a revised schedule be developed. Should there be a disagreement or the schedule is expected to exceed the maximum completion times given in Table 2, the issue should be elevated to the next higher level of management for resolution. Following the resolution of proposed schedule changes, agreements between DRP and technical branches should be documented in revised work request fonns.
2.5 Work Request Form The NRR Work Request Form, presented in Attachment 1, is used to coordinate the planning of amendment reviews performed by TB personnel. Project Managers are responsible for initiating the work request whenever the amendment work planning determines that TB review is appropriate. Project Managers submit work requests to appropriate tbs with sections completed providing background information and a description of the assistance being requested. Following the resolution of proposed changes to a previously accepted work request form, agreements between DRP and technical branches should be documented in a revised work request form. Additional details regarding completing a work request form are provided in Attachment 1.
Guide for Processing License Amendments Page 2.15
1 3.0 Public Notification The public notification process is the primary mechanism for the NRC to meet its goal regarding open-ness to the public. The staff's need to determine whether an amendment request involves no significant hazards consideration and to seek public comment and provide an opportunity for a hearing regarding the proposed amendment is defined in 10 CFR 50.91 and other regulations. Additional guidance regarding the determination of no significant hazards considerations can be found in the Federal Register publica-tion of the final rule and supplementary information (51 FR 7751). The no significant hazards consid-eration standard is a procedural criterion that governs whether an opportunity for a prior hearing must be provided before action is taken by the NRC, and whether prior notice for public comment may be dis-pensed with in emergency situations or shortened in exigent circumstances
- For those amendments that do not satisfy the criteria for a no significant hazards consideration, an individual notice in the Federal Register will solicit public comment and announce the opportunity for a hearing prior to the issuance of the amendment. These amendments would not meet the categorical exclusion criteria from 10 CFR 51.22 and require an EA.
The majority of amendment requests are found to satisfy the no significant hazards consideration criteria l and can therefore be handled in the routine fashion. The regulations specify that the normal course of business is to provide a 30-day comment period following publication of a description of the proposed amendment, along with its associated proposed NSHCD. If the staff determines that the request involves ;
no significant hazards consideration, the regulations allow for issuance of the amendment with less than a 30-day comment period. A brief summary of the various public notification altematives is provided below. Licensing Assistants maintain standard formats and the most recent guidance related to the notification process.
3.1 Normal (30-day) Public Notification The normal process is to publish a notice in a biweekly collection of notices in the Federal Register. The deadline for collection of the notices for a given biweekly publication is approximately two weeks prior to the publication date. This time combined with the 30-day comment period results in an effective minimum period of between six to eight weeks from the date of submittal to the end of the comment period. The LAs have the notices on the R drive on the LAN. They are updated by one person. The file names are listed and defined on the secretaries' distribution list. The LAs can also provide the documents needed.
If the required schedule for issuance of an amendment will not accommodate the normal biweekly pub-lication of the notice, an individual notice can be published in the FederalRigister. Licensing Assistants have the standard notice format and contacts in the Rules Review and Directive Branch (ADM) to (3) Although it may be legally permissible to issue an amendment for which a hearing has been requested, provided that the staff prepares a final no significant hazards determination, NRR Office Director concurrence and Commission notification are required if the staff plans to do this (see Section 5.0).
Guide for Processing License Amendments Page 3.1
accomplish this task. Publication of an individual notice can be accomplished in three to four working days depending on the time of day that the notice is submitted to the Rules Review and Directive Branch; an individual notice will therefore support issuance of an amendment approximately five weeks after the amendment request is submitted.
Project Managers are expected to prepare the notice as soon as convenient following receipt of an incom-ing amendment request. Masters for public notices are available from LAs. Template formats exist for both the staff's acceptance of the licensee's NSHCD and a determination prepared by the staff. The latter is usually prepared by PMs should they choose to rewrite the licensees' submittal for editorial style or to reduce length. The description of the amendment should be brief and broadly characterize the aspects of the license amendment (including TSs proposed for modification)in a form such that the general public can readily understand the purpose of the amendment. The notice should not be proscriptive as to a precise section number, technical specification, wording, or specific engineering parameter values.
1 Licensees will often supplement submittals with additional information and changes to the original pro- '
posed amendment. The SE should include a discussion of any changes submitted by the licensee. All applications and supplements to an application should be sent under O&A (50.30). The licensee must notify the State (50.91) by providing a copy to the State. Supplemental submittals raise the question of I whether an additional request for public comment and opportunity for hearing should be published in the Federal Register. The Office of the General Counsel (OGC) has advised that any significant change to ,
the original submittal should be renoticed. The amendment issued should be all or part of the !
amendment application noticed with only changes that are within the scope of the notice description permitted without renotice. Changes or additional information that are within the scope of the notice description need to be addressed in the SE or notice of amendment issuance and provided in a submittal j from the licensee on the docket with a finding that they were within the scope of the original notice and initial proposed no significant hazards consideration determination. When in doubt regarding the need to renotice, PMs may consult with LAs and OGC. Early co: sultation and coordination with licensees is extremely valuable in terms of minimizing the potential need for renoticing.
3.2 Emergency Public Notification The emergency public notification guidance is contained in 10 CFR 50.9)(a)(5) where it states, !
l "Where the Commission finds that an emergency situation exists, in that failure to act in a timely way would result in derating or shutdown of a nuclear power plant, or in pre-vention of either resumption of operation or of increase in power output up to the plant's licensed power level, it may issue a license amendment involving no significant hazards consideration without prior notice and opportunity for heanng or for public comment."
Page 3.2 Guide for Processing License Amendments
A final NSHCD is provided in the safety evaluation and the notice of amendment issuance announces the opportunity for a hearing and public comment after issuance. Another limitation related to the use of this alternative is that the licensee must explain why the emergency situation occurred and why it could not avoid the situation, and the staff must determine, and document in the SE, that the licensee has not abused the emergency provision.
Use of the emergency provisions should be limited to those cases in which the staff cannot solicit public i '
comment using the exigent circumstances discussed in the following sections. As a rule of thumb, if a valid amendment request is submitted with less than reven days before the need to issue the amendment, the request should be processed under emergency circumstances if the licensee Ns shown that an emer-gency situation exists. Licensing Assistants maintain useful models and guidance related to emergency amendments.
The emergency provisions are also used for those amendment requests that have been noticed, remain within the comment period, and changes in circumstances require issuance prior to the expiration of the comment period. Because the use of the emergency provision requires licensees to explain why the con-dition could not have been avoided, the licensee is requested to submit an explanation of the change in circumstances and formally request the issuance of the amendment before the expiration of the comment period.
3.3 Exigent (15-day) Public Notification If a license amendment request is submitted with a need date of more than seven days but less than four or five weeks in the future, the request should be processed under the exigent circumstances discussed in 10 CFR 50.91. The preferred exigent process is to use a shortened public notice period in the Federal Register. The regulation states that the comment period must be at least two weeks and maintains the normal 30-day period to request a hearing. In general, the content of the notice is the same as a normal individual notice except for the shortened comment period. The safety evaluation must include a final NSHCD and a section that justifies the use of the exigent circumstances process. Licensing Assistants maintain useful models and guidance related to exigent amendments. Because of the time required for document distribution, advance copies of the incoming amendment application should be sent to the public document rooms (PDRs) for 15-day FederalRegister notices.
3.4 Exigent Local Notification For those amendment requests that require disposition in less time than needed for a 15-day comment period in the Federal Register, the regulation provides an alternative. The second type of exigent amendment application involves the use of local media to provide reasonable notice to the public in the area of the licensee's facility. The standard practice for this attemative has been to secure advertising in local newspapers. The NRC process to prepare an announcement, receive concurrences, and arrange funding normally requires at least two to three days. Newspapers usually require receipt of the announcement two working days before publication. Allowing several workdays for a comment period results in a minimum time of approximately seven workdays from the submittal of the request to the issuance of the license amendment.
Guide for Processing License Amendments Pqe 3.3
J De process to secure advertising for an exigent amendment involves preparing the araouncement and securing funding and financial approval for the advertisement. Dese two processes r.eed to be done in parallel. He LAs have additional details and examples of this process.
Because the announcement refers the public to the PDR or Local PDR to review the licensee's request, PMs need to erasure that copies of the incoming amendment application are placed in these locations before publication of the advertisements. While there is no legal minimum time required for nuification .
prior to granting the amendment, the PM should try to provide several days of prior notice. He safety evaluation must include a fm' al NSHCD and a section that justifies the use of the exigent circumstances process.
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Page 3.4 Guide for Processing License Amendments l
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l 4,0 Safety Evaluation :
The SE provides the technical, safety, and legal basis for the NRC's disposition of a license amendment request. The SE should provide sufficient information to explain the staffs rationale to someone unfamiliar with the licensee's request. The SE includes a brief description of the proposed change, the regulatory requirements related to the issue, and an evaluaticn that explains why the staffs disposition of the request satisfies the regulatory requirements. Given that the SE serves as the record of the staffs dis-position of a license amendment request, the information relied upon in the SE must be docketed corre-spondence. This is not meant to hamper questions and clarifications by telephone or in meetings. How-ever,if the information is important in the staffs decision-making process, it must be formally provided by the licensee. This guide does not provide specific guidance on the technical performance of evalua-tions. Project Managers and TB reviewers should establish the appropriate scope and depth for the review as part of the work planning discussed in Section 2 (giving due consideration to the rig-significance and technical complexity of the proposed change, the availability of precedent reviews, the timeliness goals, the principles of good regulation, the operating plan, and other governing procedures such as the Standard Review Plan). GeneralF uidance regarding SE planning and control, the use of precedents, guidelines on requesting additional information, and the recommended format of SE repons is provided below.
4.1 Evaluation Planning and Control Safety evaluations can be prepared by PMs and technical staff personnel, with or without contractor assistance. The determination of who performs the lead reviewer function depends on the technical complexity of the review, the risk significance of the proposed change, and the availability of a good precedent SE (see Figure 3 and the corresponding discussion in Section 2.4.2). Procedures for planning and controlling SE work are provided below.
4.1.1 Project Manager Review For those amendment applications determined to be appropriate for PM review, the PM should establish the estimated resource requirements and schedule. Project Directors may review schedule inputs,includ-ing resource estimates, and may ask PMs tojustify their resource or schedule estimates. See Chapter 2.0 for more details on planning for a review.
Tools for completing the evaluation include those previously described for finding precedent reviews. In addition, various applications on the NRC Local Area Network includes documents containing technical guidance (regulations, regulatory guides, the Standard Review Plan, generic communications) and selected other documents. Using the software computer applications to perform word searches on this collection of documents enhances the PM's ability to prepare evaluationt This is especially true for amendment applications that are not introducing significant changes to the traditional licensing-bases methodologies. The PM must review the precedent for accuracy, applicatility, and completeness against the details of the submittal and the plant. -
Umde for Processing License Amendments Page 4.1
Project Managers may also request some assistance from technical staff during a review for which the PM is preparing the SE. This request can be accomplished informally by discussing the amendment request with appropriat t technical staff or by negotiating technical staff assistance using the work request form (see Attachment 1). In such cases, the PM should specify the support requested. Two examples of output PMs may request are 1) a cursory evaluation of a PM's review strategy with suggestions related to applicable regulations, guides, industry standards, or other references; and 2) a cursory review of a (raft SE, RAI, or other document prepared by the PM.
The PM may also provide input regarding the licensee's performance for use in the assessmen of licensee performance. The PM is responsible for assembling the appropria:e input (whether input is initiated by the PM or by the TB), for the proper documentation of the assessment in the amendment i
cover letter to the licensee, and the forwarding of the assessment to the appropriate regional contact for possible entry into the plant issues matrix. As appropriate, the PM should provide feedback, either orally fc.- routine situations or in the amendment cover letter for special circumstances, to the licensee regarding the quality of its submittals.
4 4.1.2 TechnicalStaff Review Initial development, negotiation, and agreement of evaluation work plans are addressed in Section 2.4.
Changes to the agreed upon work plan are sometimes necessary due to circumstances related to the operation of the licensee's facility, the PM's activities, or the activities of the TB. As soon as possible after determining that a revision to the schedule is required, the PM or TB should contact the other party to discuss a proposed revised completion date. The revision should be documented by completing the appropriate sections of the Work Request Form. In order to minimize surprises, the PM should also i remain cognizant of the status of the review by monitoring WISP and having periodic discussions with !
the reviewer or section chief. For those cases in which the PM and technical staff cannot agree on a j revised schedule or the anticipated completion time exceeds 12 months, the problem should promptly be I brought to the attention of the appropriate NRR manapment.
The TB staff may also provide input to the PM regarding the licensee's performance for use in the assessment of licensee performance. This is not required; however, should the TB have substantive insights or be requested to provide input by the PM, an assessment of licensee performance should be provided as an attachment to the SE input memorandum from the TB to DRP.
4.1.3 Centractor Review Occasionally, technical staff will use contractors to assist in performing a review. Prr. ject Managers should treat the amendment the same as a technical staff review and comrnunicate with the technical staff member designated as the contract's technical monitor. Project Managers should work with the technical monitor to establish the level of review, schedule, and the statement of work.
Page 4.2 Guide for Processing License Amendments l
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4.2 Use of Precedent Safety Evaluations t'
There are a number of considerations and cautions regarding the use of a precedent safety evaluation by NRR staff. These include, but are not limited to, the following:
. ensure that the precedent is appropriate for use with the intended amendment i .
ensure that the precedent meets current expectations for format, findings, internal NRR guidance for rhe item, NRR guidance to industry, and technical content i
. ensure that previous plant specific information is replaced with information relevant to the current plant obtain TB concurrence, unless formal guidance has been issued giving an alternative concurrence process 4.3 Requests for AdditionalInformation i
The staff is accountable for the appropriateness of RAls and should ensure that each question in an RAI was developed with proper consideration of the technical complexity, risk significance, existence of
, precedent amendments, the appropriate scope and depth of the review, and the resource implications for both the staff and the licensee. RAls should be directly related to the applicable requirements related to the amendment application, and consistent with the applicable codes, standards, regulatory guides, and/or the applicable Standard Review Plan sections. The following guidance is provided for comn.on RAI concerns:
- 1. Questions included in the formal RAI should ask for information that is required to make the regulatory finding. Each question should explicitly state the regulatory basis for asking the licensee for the information. "
- 2. The staff should not issue any RAls if the staff has (or can infer with a reasonable degree of l confidence) the necessary information to make the regulatory finding. When an RAI is necessary, the staff should make every effort to limit itself to one round of RAls per TB for an amendment application. The established timeliness goals are likely to be exceeded if multiple RAls are needed !
to complete the staff's review of a license amendment application.
- 3. Frequent and early communications between the PM, TB staff, and the licensee can avoid the need for many RAls. To ensure an effective and efficient review, PMs are required to notify the licensee prior to issuing an RAI and document the conversation in the RAI cover letter. This notification should include a discussion of the proposed RAI with the licensee.
- 4. Before developing an RAI, the staff should ensure that the information is not already available to the i
Guide for Processing 1.icense Amendments Page 4.3
1 1
I staff or that the answer could not reasonably be inferred from general knowledge or existing regulatory requirements.
- 5. Questions should be specific rather than overly broad, and the response to the RAI should be of value to the staff s safety evaluation basis.
- 6. If an RAI is issued and the licensee's response does not fully address the RAI, the PM will set up a meeting or conference call with the licensee management to discuss the discrepancy and what needs to be providea to the staff on a timely basis in order to complete the amendment review. Failure of the licensee to provide timely information should result in a denial or withdrawal of the amendment based on a deficiency in the submittal as opposed to a definitive, negative finding by the staff based on the technical merits of the proposed change. The licensee may submit a new application (with the identified discrepancies corrected) at any time in the future.
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- 7. If a disagreement arises with the licensee regarding the appropriateness of an RAI or whether or not the information was provided, the issues should be raised immediately to management for proper resolution.
8.
' Consistent with Section 4.2, the staff should make use of previous reviews in order to avoid asking unnecessary questions.
- 9. The timely issuance of an RAI, if necessary, and the licensee's agreed upon time to respond should be factored into the schedule established to complete the review within the licensing action timeliness goals (e.g., FYOO and beyond goals of completing 95c7o of applications in less than 1 year).
The intent of this guidance is not to limit the staff from getting the information that is needed to perform a technical review; rather, this practice is needed to ensure that the information requests will be productive and focus staff and licensee resources on the pertinent issues necessary to make a regulatory decision. I l
4.4 Regulatory Commitments
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During the review of license amendment applications, the staff will base its findings on a variety of information provided by the licensee. Some information considered important by the reviewer will not be addressed specifically in the affected technical specifications (which would require prior NRC approval of subsequent changes). Those matters considered important to the staff but not requiring the staff's prior approval of subsequent changes have been traditionally referred to as commitments. It is important to consider commitment management in its proper context as an integral part oflicensees' and the NRC staff's control of each facility's licensing-basis information. To address identified problems, improve internal processes, and improve its interactions with licensees, the staff plans to define more formally a hierarchy of licensing-basis information and related processes in an NRR office letter (proposed Office Letter 807, " Control of Licensing Basis for Operating Reactors," to be completed by September 1999). The hierarchy relates to the change control and reporting processes associated with Page 4.4 Guide for Processing License Amendments
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the various elements of the licensing basis. An approach to the hierarchy that is likely to be included in the pending office letter is as follows:
- 1. Obligations - conditions or actions that are legally binding requirements imposed on licensees through applicable rules, regulations, orders, and licenses. The imposition of obligations (sometimes refe:Ted to as regulatory requirements) during routine interactions with licensees should be reserved for those maners warranting prior NRC approval of changes. ;
1 I
- 2. Mandated Licensing Basis Documents - documents, such as the UFSAR, the quahty assurance 1 program, the security plan, and the emergency plan, for which the NRC has established requirements for content, change control, and reporting.
- 3. Regulatory Commitments - explicit, written, docketed statements by a licensee agreeing or volunteering to take specific actions that change the licensing basis of a nuclear power plant. A regulatory con.mitment is appropriate for matters in which the staff has a significant interest but that do not warrant either a legally binding requirement or inclusion in the UFSAR or a program subject to a formal regulatory change control mechanism.
- 4. Non-Licensing-Basis Information - information that is exchanged during routine interactions between the NRC staff and licensees but that does not warrant being considered as part of the
" licensing basis."
Although the concept of a hierarchy of licensing-basis information has existed for some time, the planned emphasis on determining the proper classification of information within the hierarchy will require changes to the current practices used by licensees and the NRC staff. Office Letter 807 will describe the regulatory basis, change control mechanisms, reponing mechanisms, applicable guidance, benefits and limitations, and other characteristics of the various types of licensing-basis information for operating plants.
As to the part of the licensing basis that involves regulatory commitments, the staff is working with the Nuclear Energy Institute (NEI) on a revision of the industry guidance document on managing commitments made to the NRC. After completing discussions with NEI and informing the Commission of the results of those discussions, it is the staff's intent to complete its work on an NRR office letter (proposed Office Letter 900, " Managing Commitments Made by Licensees to the NRC" to be completed by September 1999), on how the staff should deal with regulatory commitments made to the NRC by licensees. In general, commitments will be handled within current rules and existing practices, with emphasis on consistency, on mutual understanding by the staff and licensees of proposed actions, subsequent controls, and reporting, and on improved assignment of individual and organizational responsibilities for identifying, documenting, and subsequently verifying regulatory commitments made by licensees. Additional information pertaining to current staff practices for handling regulatory commitments is provided in SECY 98-224, " Staff and Industry Activities Pertaining to the Management of Commitments Made by Power Reactor Licensees to the NRC," dated September 28,1998.
The escalation of commitments into license conditions, requiring prior NRC approval of subsequent Guide for Processing License Amendments Page 4.5
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changes, should be reserved for matters that sa - he criteria for inclusion in technical specifications l by 10 CFR 50.36 or inclusion in the license to adoress s significant safety issue. Routiae commitments l
on technical matters that do not satisfy the above criteria for license conditions should be discussed in the ;
staff's safety evaluation but shcald not be escalated into formal license conditions; licerses that have l been amended to capture routine comrrdtmems may be revised in future license amendment requests to delete the special appendix. If the staff determines that a license condition imposed in a recently created appendix should be maintained as an obligation as described in the hierarchy of licensing ba is information, the condition may be added to the operating license.
For the time being, the staff should continue imposing conditions on license amendments that involve, as a vital element of the staff's approval, the subsequent placement of information in a particular mandated licensing-basis document. Commonly, this type of amendment relocates requirements from a facility's technical specifications to its UFSAR. The condition will be imposed along with other legally binding aspects of the amendment (e.g., when the amendment is effective and when the amendment must be implemented) on the amendment page that is signed by an authorized member of the NRR staff.
Guidance being developed for use by the NRC staff will address what types of licensing-basis information should be incorporated into various documents, such as the UFSAR.
4.5 Safety Evaluation Format There are several sections of a typical SE, which are described below. Attachment 2, " Safety Evaluation Form and Content Guide," provides additional guidance,in a checklist form, for the content of some of the key sections of an SE. These should be used to quickly assess the completeness of key sections of the SE.
4.5.1 Introduction The introduction section of the SE should provide a brief description of the licensee's amendment request. Supplementary submittals and their effects on the scope of the original notice and the no significant hazards consideration determination, if not renoticed, are also described in this section. A typical introduction consists of one or two paragraphs. The description of the amendment included in the public notice may be useful in preparing the description in the SE's introduction.
4.5.2 Background The background section provides the regulatory framework for the licensing action. This section should provide a summary of the relevant regulations, regulatory guides, generic letters, or other basis for the current requirements and the requirements following the amendment. A description of the system or component, if applicable, may also be needed to better describe the effects of the change. This information forms the basis or criteria that will enable the staff to determine the acceptability of the licensee's amendment request.
The background section may also provide a summary of the licensee's rationale for the proposed change, d PaFe 4.6 Guide for ProcessinE License Amendments
l i
including operating problems, changes in technology, or changes in analytical approaches. This informa-tion forms the "why" of a licensee's request. Although the reason the licensee is requesting an amend-l l ment may be irrelevant to the acceptability of th ,roposal, it may warrant inclusion in the evaluation.
This information may also suppon the conc lo,rons of the evaluation, in that the proposed change has minimd safety consequences but offers advantaes in terms of reduced radiatic,n exposures, reduced costs, or resolution of other hardships.
i The above material related to regulatory acceptance oimria and the licensee's incentive for the proposed change may be included in the introduction and evalu.rion sections in lieu of having a separate back-ground section. However, the preferred format includes a background section.
i 4.5.3 Evaluation l
r i The evaluation section documents the staff's evaluation of a proposed change against the relevant regula- '
- tory criteria. The evaluation should include a description of the proposed changes and an analysis of the l proposal in terms of regulatory requirements, established staff positions, ind.astry standards, or other relevant criteria. The evaleation should also contain the staff's specific conclusion that the proposed j change is acceptable in terms of public health and safety. Very broad statements such as "the staff evaluated the changes and found them acceptable." although commonly used, do not provide sufficient l
i justification for a licensing action. See the attached " Safety Evaluation Form and Content Guide" for j more information.
4.5.4 Other l
In addition to the technical considerations of the SE, the issued amendment will include the following sections. Licensing Assistants maintain standard language and examples for these sections.
l
- Regulatory Commitments (ref. SECY 98 224) Safety evaluations for amendment requests l containing regulatory commitments should discuss the commitments and should state that the staff l finds that the subject matter is adequately controlled by the licensee's administrative programs. If an i amendment includes numerous regulatory commitments, a separate section in the SE may be used to )
list the commitments and state the staff's finding regarding classification of the information as
{
regulatory commitments. Typical wording regarding regulatory commitments is as follows:
(3tatement of Regulatory Commitment (s)...] The NRC staff finds that reasonable coneols for the implementation and for subsequent evaluation of proposed changes pertaining to the above regulatory commitment (s) are best provided by the licensee's administrative pocesses, including its commitment management program. The above regulatory Wmm'tments do not warrant the creation of regulatory requirements (items requiring rnor .hRC approval of subsequent changes). The staff notes that pending industry at d replatory guidance pertaining to 10 CFR 50.71(c) may call for some information related to the above commitments to be included in a future update of the facility's final safety analysis repon.
1 Guide for Processing 1 icense Amendments Page 4.7 l
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De sentence pertaining to inclusion of information in updates to FSARs is an interim step to the full implementation of the previously described hierarchy of licensing-basis information. Completion of industry and staff guidance for updating of FSARs is scheduled to be completed by September 1999.
. Emergency / Exigent Provisions - Safety evaluations for amendments processed using the emergency or exigent provisions of 10 CFR 50.91 must include a section that supports a finding that the licensee has used its best efforts to make a timely application.
- Final No Significant Ilazards Consideration Determination - Safety evaluations for amendments issued using the emergency or exigent provisions or for amendments for which a hearing has been requested must include a final NSHCD.
State Consultation - This section states that the NRC has consulted with the appropriate State official in accordance with 10 CFR 50.91. If there are State comments, they should be addressed in this section. Comments received from members of the public should be addressed in a separate section of the SE.
Environmental Considerations - Ties section lists the appropriate categorical exclusion from 10 CFR 51.22 to explain why the staff did not prepare an EA. The PM determines if the amend-ment meets a categorical exclusion or not. For those amendments involving an EA, this section will reference the assessment's publication in the Federal Register. Note that Project Managers should plan for the fact that the EA and finding of no significant impact must be published in the Federal Register prior to the issuance of the amendment. Licensing Assistants maintain standard, OGC-accepted wording that should be used in this section.
Conclusion - This section states the staff's conclusion that the amendment will not endanger pubhc health and safety.
References - All documents referenced in the SE should be readily available for public inspection (if not proprietary) in the NRC PDR or available for purchase from other sources in the public domain such as Government Printing Office, the National Technical Information Services, university or special technical libraries, or the originating organizations.
Page 4.8 Guide for Processing License Amendrnents
5.0 Review and Concurrence Review and concurrence is the process by which the quality and consistency of the amendment package is verified. Concur twe involves obtaining the approved signatures required for amendment issuance. It is the PM's responsibility to ensure that appropriate concurrences are received for the amendment pack-age. Tigure 4 diagrams the considerations that should be made in determming who should be included on the concurrence chain. When the concurrence chain is determined the name, title, and organization of each individual should be entered on an amendrnent routing form (Attachment 3). Amendment 1 ackages prepared by PMs must always be concurred on by the tbs associated with the technical area (s) of the proposed change unless the tbs have agreed that a PM or lead PM may perform their function (e.g., for certain line item improvements). Although affected by reorganizations, the Standard Review Plc.n remains useful in determining the appropriate branch.
Licensing Assistants perform an initial review and concurrence, before sending the package to other NRR organizations. During this review, the LA ensures that the package is complete, in the correct format for text and graphics, and all the required steps have been completed.
When the SE is prepared by the tbs, the PM has the responsibility for integrating it into the overall
]v amendment package. If, during this integration, the PM makes substantial changes to the SE, the TB individual involved in the preparation of the original SE should be an early reviewer in the concurrence chain to ensure that there is no change in technical content or original intent. In any case, the concurrence page should indicate the TB originator of the SE (see OL 101). SE input from a TB that is h used with only minor editorial changes does not need additional concurrence by that TB. When TB concurrence is not riecessary, include the appropriate TB in a concurrence block and cross the TB off with a note that SE input dated was provided and no major changes were made.
f Guidance and signature authority for special categories of amendments, such as changes in licensed
) power level, are provided in OL 101.
Ir. addition to the appropriate TB, the Technical Specifications Branch (TSB) must be included on the concurr:nce chain when the am ndment package involves significant deviations from the latest revision of the imp,ved STS. Project Managers may also request concurrence by TSB on packages related to the irr plementa%n of the criteria for limiting conditions for operation contained in 10 CFR 50.36.
Involvement of TSB also may be important in those cases in which there are questions regarding prc posed changes that are consistent with the most recent STS version or 10 CFR 50.36.
t Guide for Processing License Amendments Page 5.1
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Amendment i r Package l V Spec.l ia No if Concurrence Guidance g ?
Concurrence Yes 1r 1r Obtain Required No SE h unences Substantial p,,
Revision to g pg TB Input 0 7 37 Yes OGC No Yes 9r No Concunence Required TB ?
Concunence Yes
- 1 r 1r OGC TSB No and/or PDLR Concurrence Needed 1 r
?
PD/PM Yes Concurrence 3,
TSB Concunence l' Contact
? State i
1 r Approved Amendment 1 i
Figure 4. Planning Strategy Guidance for Levels of Application-Precedent Similarity and Review Technical Complexity Page 5.2 Guide for Processing License Amendments I
i-l OL 906 provides guidance related to PGEB concumnce on EAs. The OGC must concur on all license amendments, unless an explicitly defined exception is documented in a memorandum of understanding between NRR and OGC"). The OGC reri:.ws the amendment package for legal defensibility and completeness.
' To assist those requested to concur, amendment packages should include:
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- copy of the license amendment 1
I e copy of the SE j
- copy of the incoming license amendment request, including all related docketed correspondence i
i e copy of the Federa/ Register notice (or the forwarding memorandum) 4
- copy of any relevant background information, including similar evaluations used in preparing the SE, related internal documents, and easily attached reference material 4
j
- memorandum forwarding the FederalRegister notice ofissuan:e
- routing form, including the applicable SRP section number 1
] Parallel concurrence may be used to expedite the review and concurrence process if the amendment
- . requires several concurrences and timing is of concem. PMs should ensure that comments incorporated
) during the concurrence process do not affect the bases for concurrences received prior to changing the j amendment package. Project Directors or their designees (possibly the PMs) must provide final
- ' concurrence for all amendments processed, or must confirm and document amendment package correctness by their signature on the amendment cover letter and amended license.
- 1 NRR Office Director concurrence and Commission notification at least 5 days prior to issuance is
- required for any license amendment for which:
i
- 1. the staff has made a fm' al no significant hazards considerntion determination, and i
i 2. a hearing has been requested, which will not be conducted prior to issuance of the amendment.
The LAs can be consulted for the standard format for Commission notification.
(4) As of December 1998, OGC concurrence is required for all license amendments. Should a memorandum of understanding be developed that changes this policy, NRR/DRP personnel will be informed via an announcement or memorandum.
Guide for Processing License Amendments Pare 5.3
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6.0 Amendment Preparation and Issuance After the required concurrence signatures are obtained, the amendment package is issued to the licensee and the notice is sent to the Rules and Directives Branch (ADM) for transmittal to the Federal Register.
The no significant hazards consideration (NSHC) contact of the State must be called for comments prior to issuance of an amendment. The Office of Administration and the Office of the Secretary are contacted prior to issuance to determine if comments from the public or petitions to
, intervene were received on the proposed amendment. Although PMs are responsible for amendment issuance, LAs perform most of the required administrative functions and are familiar with current practices. The final package should include:
i e
a letter transmitting the amendment to the licensee for signature by PM a standard distribution or "cc:" list i
1 e the license amendment for final signature by the appropriate level of management (consult Office Letter 101 for the current practices regarding the delegation of signature authority) e
- the revised TS or license pages a
the SE, with reference to an EA if appropriate (the EA is issued as a separate document) input to the biweekly Federal Register notice or a separate Federa/ Register notice ofissuance e
addressing for intemal distribution to TB, TSB, Regions, etc.
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Guide for Processing License Amendments Page 6.1 l
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i Attachment 1 - NRR Work Request Form and Instructions
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l This attachment to the Guidefor Processing License Amendments includes the NRR Work Request Form
)
and related instructions. The Work Request Form is used to coordinate amendment reviews that are '
performed by tbs. Project Managers should complete the " Background Information" and " Assistance Requested" portions of the form. The appropriate TB representative should complete the " Technical Branch Response" portion of the form. Various levels of discussion between the PM and TB may be required to reach agreement on the estimates included in the work request process. The technical complexity associated with the amendment request and the availability of useful precedents will partially determine the levels ofinteraction required. The TB should either agree with the PM estimates / requests or initiate negotiations such that agreement is reached within 5 working days of receipt of the work request. Any inability of the TB and PM to reach agreement on a work request should be brought to the attention of appropriate NRR management.
f Revisions should be negotiated between the PM and TB in order to minimize delays, maintain technical adequacy of reviews, and ensure the best utilization of NRR resources. Revisions can consider changing the scope of the review, TB product, estimated staff-hours, target completion date, or a combination of these to achieve the best results.
Additional information for each item on the form is provided below.
Priority - the NRR priority for the amendment (1,2, or 3)
Target Date - list the target date for the TB product (see Section 2.4.3)
Stafi hours estimate - provide estimate of staff-hours that will be required for the TB to provide the requested product (see Section 2.4.2)
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PD Signature /Date - assigned PD signature formalizing DRP request for assistance in the review of an amendment application with appropnate priority, requested target date, and estimates of appropriate expenditure of staff resources (staff-hours).
TB Signature /Date - designated TB staff signs work request following agreement on the details of the work request (scope and depth, resources, schedule). Signature indicates acceptance of the work activity and agreement with the information on the form. Subsequent changes to the information should be coordinated with the PM and documented using a revised work request form.
BACKGROUND INFORM ATION The Background Information section should be completed by the PM. Information to be provided in this section includes:
Guide for Processing License Amendments Attachment 1-1
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Plant - the name of the plant associated with the application Unit (s)- the units affected by the proposed amendment Project Director - the Project Director for the subject facility Project Manager / Phone /E-mail /M/S - the Project Manager, phone extension, E-mail address and mail stop TAC No(s). - the TAC number (s) assigned to the amendment request. Unless directed otherwise, reviewers will divide work hours evenly among TAC numbers listed on the work request form.
Licensee Proposed Action / Submittal Date - A short description of the proposed license amendment and related facility design or operational changes; the date of the incoming submittal ASSISTANCE REOUESTED
, This section should be completed by the PM. Information to be provided in this section includes:
Technical Branch - list the TB being requested to provide support. A separate work request form is required for each TB dedicating significant staff-hours to the review of the proposed amendment.
1 Other tbs Providing Input / Concurrence - list any other tbs that have been or will be asked to participate in the review by either providing input to the SE or concurrence on the final package.
i Scope of Review / Product Requested - describe the level of assistance and product requested from
' the TB. Examples include (1) complete review of a proposed amendment with documentation provided as an SE and (2) provide background information ( applicable regulations, regulatory guides, industry standards) to assist PM in preparation of SE without need to send formal e
memorandum.
Possible Precedents -list possible precedents found during the work planning activities i
i i
PM Signature /Date - PM signature to authorize TB effons following agreement on the details of the !
work request (scope and depth , resources, schedule). Subsequent changes to the information should be coordinated with the TB and documented using a revised work request form. '
TECHNICAL BRANCH RESPONSE TB Product - acknowledges that requested product will be provided or proposes alternative based upon technical issues, resource limitations, or existence of useful precedents.
Assigned Reviewer / Phone /E-mail - lead reviewer assigned to prepare TB product and interface l
1 Attachment 12 Guide for Processing License Amendments
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4' '
- i with the PM during the review process (should agree with reviewer ent: red into WISP); phone
, extension and E-mail address.
Comments - this space is available forTB to provide any comments regarding the scope and depth, resources, schedule, technical issues, suggested involvement of other tbs, or other concerns or suggestions.
I J
5 i
I 1
Guide for Processing License Amendments Attachment 1-3
NRR WORK REQUEST i PM REQUEST AGREED TO*
. Priority: Priority:
, Target Date: Target Date:
Staff-br Estimate: Staff-br Estimate:
PD Signature /Date: Branch Signature /Date:
BACKGROUND INFORMATION j Plant: Unit (s):
i Project Director:
Project Manager: Phone: E-mail: M/S: O- ,
TAC No(s): M M M I
, Licensee Proposed Action / Submittal Date:
I l
i l
t .
ASSISTANCE REQUESTED l Technical Branch:
i Other tbs Providing Input / Concurrence:
Scope of Review / Product Requested:
1 i
Possible Precedents:
PM Signature /Date:
4 3 TECHNICAL BRANCH RESPONSE i
, TB Product:
Assigned Reviewer: Phone: E-mail:
Comments:
i k
- Any change in target date, priority or staff-br estimate should be negotiated with the PM before revising.
! In addition, please inforrn the PM of any additional tbs required, that are not identified above, for the review.
- Return to PM Within 5 Workina Days of Receipt -
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- "" . Attachment 2 - Safety Evaluation Form and Content Guide
[ INTRODUCTION
, O Reference to licensee's amendment request?
O Brief description of proposed change?
O Reference to any supplemental submittals and impact on the no signincant hazards consideration determination?
O Reference to any related NRC activities (e.g., generic letters)? '
BACKGROUND D Applicable regulations cited?
O Specific applicable regulatory criteria described?
O Description of system / component and current requirements included? !
O Purpose of amendment requests described? l
' EVALUATION O Detailed description of the proposed change included?
O Method of staff review described?
O Key information used in the review (from licensee or general knowledge) included?
O Comparison of change to regulatory criteria included?
O Regulatory commitment (s) & related finding (s)?
O Findings /conclusionsincluded?
EXIGENT / EMERGENCY CIRCUMSTANCES O If necessary,is there a discussion of circumstances and staff's l
findings?
FINAL NO SIGNIFICANT HAZARDS CONSIDERATION DETERMINATION 4
O If necessary,is there a nnal NSHCD?
STATE CONSULTATION O State consultation conducted and comments addressed?
ENVIRONMENTAL CONSIDERATIONS O Is the required ca.:.gorical exclusion or reference to a published environmental assessment included? i CONCLUSION O Is there a Staff conclusion that the action does not endanger public health and safety?
REFERENCES O All applicable utility correspondence, UFSAR sections, regulatory requirements / guidance, and industry standard / guides included (in reference section or within SE text)? .
s ..i, Attachment 3 - Amendment Routing Fcrm
~~
Licensing Assistants have developed fairly standard routing fonns that address slight Project Directorate l
variances related to LA/PM/PD concurrences and responsibilities for various duties such as consultations and ;
notifications. Each routing form is expected to include, at least, the following items:
7 B ACKGROUND INFORMATION l
r Plant name and affected unit (s) !
TAC number (s) .
Application Date Subject or description Amendment package contact, phone number, and mail stop !
. Amendment number (s) and issuance date (at issuance)
CONCURRENCE ROUTING / PACKAGE PREPARATION
{ Concurrence Chain including:
LA, PM, tbs, OGC, Management (per OL 101) 1 Technical Branches providing SE inputs !
SRP Section ,
Check for Final Package Review (PM) and PM/PD signatures l (in accordance with PD specific delegations)
Check for Final Package Review (LA) and assignment of Amendment number (s)
Dispatch directions PUBLIC NOTIFICATION / STATE CONSULTATIOE i
Initial No Significant Hazards Consideration Determination Results Federal Register Publication Information (type, date, citation) s Notice period and expiration date Check for need for final NSHCD Check for use of emergency / exigent provisions Check for environmental assessment requirements ;
Check for inclusion of notice ofissuance Check for concurrences / notifications if hearing requested ,
Check for impact on stakeholders (petitioners, etc.)
Date and findings from checks with:
State contact for comments SECY for petitions to intervene ADM for public comments Guide for Processing License Amendments Attachment 3-1
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