Regulatory Guide 1.215: Difference between revisions

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{{Adams
{{Adams
| number = ML15105A447
| number = ML091480076
| issue date = 07/20/2015
| issue date = 10/31/2009
| title = Guidance for ITAAC Closure Under 10 CFR Part 52
| title = Guidance for ITAAC Closure Under 10 CFR Part 52
| author name = Gaslevic J
| author name =  
| author affiliation = NRC/NRO/DCIP
| author affiliation = NRC/RES
| addressee name =  
| addressee name =  
| addressee affiliation =  
| addressee affiliation =  
| docket =  
| docket =  
| license number =  
| license number =  
| contact person = Burton S
| contact person = Jervey, Richard 301-251-7404
| case reference number = RG 1.215
| case reference number = DG-1204
| package number = ML15105A436
| document report number = RG-1.215
| document type = Regulatory Guide, Draft
| package number = ML091480069
| page count = 15
| document type = Regulatory Guide
| page count = 27
}}
}}
{{#Wiki_filter:U.S. NUCLEAR REGULATORY COMMISSION
{{#Wiki_filter:The NRC issues regulatory guides to describe and make available to the public methods that the NRC staff considers acceptable for use in implementing specific parts of the agency=s regulations, techniques that the staff uses in evaluating specific problems or postulated accidents, and data that the staff needs in reviewing applications for permits and licenses. Regulatory guides are not substitutes for regulations, and compliance with them is not required.  Methods and solutions that differ from those set forth in regulatory guides will be deemed acceptable if they provide a basis for the findings required for the issuance or continuance of a permit or license by the Commission.
July 2015 OFFICE OF NUCLEAR REGULATORY RESEARCH
Revision 2


This guide was issued after consideration of comments received from the public.
Regulatory guides are issued in 10 broad divisionsC1, Power Reactors; 2, Research and Test Reactors; 3, Fuels and Materials Facilities; 4, Environmental and Siting; 5, Materials and Plant Protection; 6, Products; 7, Transportation; 8, Occupational Health;
9, Antitrust and Financial Review; and 10, General.
Electronic copies of this guide and other recently issued guides are available through the NRC=s public Web site under the Regulatory Guides document collection of the NRC=s Electronic Reading Room at http://www.nrc.gov/reading-rm/doc-collections/ and through the NRC=s Agencywide Documents Access and Management System (ADAMS) at http://www.nrc.gov/reading-rm/adams.html, under Accession No. ML091480076.
U.S. NUCLEAR REGULATORY COMMISSION
October 2009 OFFICE OF NUCLEAR REGULATORY RESEARCH
Revision 0
REGULATORY GUIDE  
REGULATORY GUIDE  


Technical Lead James Gaslevic
REGULATORY GUIDE 1.215 (Draft was issued as DG-1204, dated March 2009)


Written suggestions regarding this guide or development of new guides may be submitted through the NRCs public Web site under the Regulatory Guides document collection of the NRC Library at http://www.nrc.gov/reading-rm/doc-collections/reg-guides/contactus.html.
GUIDANCE FOR ITAAC CLOSURE UNDER 10 CFR PART 52


Electronic copies of this regulatory guide, previous versions of this guide, and other recently issued guides are available through the NRCs public Web site under the Regulatory Guides document collection of the NRC Library at http://www.nrc.gov/reading-rm/doc-collections/. The regulatory guide is also available through the NRCs Agencywide Documents Access and Management System (ADAMS) at http://www.nrc.gov/reading-rm/adams.html, under ADAMS Accession No. ML15105A447. The regulatory analysis may be found in ADAMS
==A. INTRODUCTION==
under Accession No. ML14258B184 and the staff responses to the public comments on DG-1316 may be found under ADAMS Accession No.
This guide describes a method that the staff of the U.S. Nuclear Regulatory Commission (NRC)
considers acceptable for use in satisfying the requirements for documenting the completion of inspections, tests, analyses, and acceptance criteria (ITAAC). In particular, this guide endorses the methodologies described in the industry guidance document Nuclear Energy Institute (NEI) 08-01, Industry Guideline for the ITAAC Closure Process Under 10 CFR Part 52, Revision 3, issued January 2009 (Ref. 1), for the implementation of Title 10, Section 52.99, Inspection during construction, of the Code of Federal Regulations (10 CFR 52.99) (Ref. 2).  


ML15105A446.
The NRC issues regulatory guides to describe to the public methods that the staff considers acceptable for use in implementing specific parts of the agencys regulations, to explain techniques that the staff uses in evaluating specific problems or postulated accidents, and to provide guidance to applicants.  Regulatory guides are not substitutes for regulations and compliance with them is not required.


REGULATORY GUIDE 1.215 (Draft was issued as DG-1316, dated December 2014) 
This regulatory guide contains information collection requirements covered by 10 CFR Part 52 that the Office of Management and Budget (OMB) approved under OMB control number 3150-0151.


GUIDANCE FOR ITAAC CLOSURE UNDER 10 CFR PART 52  
The NRC may neither conduct nor sponsor, and a person is not required to respond to, an information collection request or requirement unless the requesting document displays a currently valid OMB control number.
 
RG 1.215, Page 2
 
==B. DISCUSSION==
Background
 
10 CFR 52.99 includes requirements for documenting and reporting the satisfaction of the acceptance criteria for each ITAAC in the combined license (COL).
 
This guide provides guidance on licensee notifications to the NRC for completed and uncompleted ITAAC.  The NRC uses these notifications to determine whether ITAAC have been successfully completed, to facilitate public participation in the ITAAC hearing process, and for inspection planning.  This regulatory guide describes methods that the NRC staff considers acceptable for licensees to use for documenting and reporting the satisfactory completion of the acceptance criteria for each ITAAC in the COL.  This regulatory guide, through its endorsement of an industry guidance document for licensees, provides guidance on complying with the requirements of 10 CFR 52.99.
 
1.
 
Development of Industry Guideline Document NEI 08-01
 
In accordance with 10 CFR 52.97(b), COLs must contain ITAAC that are necessary and sufficient to provide reasonable assurance that the facility has been constructed and will operate in accordance with the license, the Atomic Energy Act, and NRC regulations.  After issuance of a COL, a licensee completes all the ITAAC contained in the COL during construction and then submits closure notification letters to the NRC pursuant to 10 CFR 52.99.
 
Two types of ITAAC notifications from licensees are required by 10 CFR 52.99.  The first type of ITAAC notification (ITAAC closure letter) is submitted under 10 CFR 52.99(c)(1) and informs the NRC of the basis for the licensees determination that an ITAAC has been successfully completed.


==A. INTRODUCTION==
ITAAC closure letters must be submitted for all ITAAC, with the exception of ITAAC resolved at COL
Purpose
issuance under 10 CFR 52.97(a)(2). The second type of ITAAC notification (uncomplete ITAAC
notification letter) is submitted under 10 CFR 52.99(c)(2) at least 225 days before scheduled initial fuel load and describes how all uncompleted ITAAC will be successfully completed prior to fuel load.


This regulatory guide (RG) describes a method that the staff of the U.S. Nuclear Regulatory Commission (NRC) considers acceptable for use in satisfying the requirements for documenting the completion of inspections, tests, analyses, and acceptance criteria (ITAAC) for the implementation of Title 10 of the Code of Federal Regulations, (10 CFR) 52.99 Inspection during construction; ITAAC
Operation (which includes loading fuel) cannot commence until the Commission finds under 10
schedules and notifications; NRC notices (Ref. 1). 
CFR 52.103(g) that all acceptance criteria in the ITAAC are met.  To provide a basis for the Commissions finding and to ensure that ITAAC closure notifications contain sufficient information to satisfy 10 CFR 52.99, the licensee can follow industry guideline NEI 08-01.


Applicable Regulations  
NEI 08-01 provides guidance for licensees on major aspects of the ITAAC closure process in the following sections:  


*  
*  
As required by 10 CFR 52.99, licensees must notify the NRC that the prescribed inspections, tests, and analyses have been performed and that the prescribed acceptance criteria are met for each ITAAC included in their combined license (COL). The ITAAC closure notifications (ICNs)
Introduction
shall contain sufficient information to demonstrate that the prescribed inspections, tests and analyses have been performed and that the prescribed acceptance criteria are met. Licensees must also notify the NRC of new information that materially alters the determination basis for a previously completed ITAAC, including how this new information was resolved, during the ITAAC maintenance phase. At or before 225 days before scheduled fuel load, licensees must notify the NRC on how uncompleted ITAAC will be completed, including the specific procedures and analytical methods to be used to complete the ITAAC. Lastly, the licensee must notify the NRC when all ITAAC included in its COL have been completed.
*
 
Definitions
*  
*  
As required by 10 CFR 52.97 Issuance of combined licenses, COLs must contain ITAAC that are necessary and sufficient to provide reasonable assurance that the facility has been constructed and will be operated in accordance with the license; the Atomic Energy Act of 1954, as amended;
General Description of 10 CFR Part 52 and ITAAC Processes
and NRC rules and regulations.


Purpose of Regulatory Guides
Role of ITAAC in 10 CFR Part 52 Process


The NRC issues RGs to describe to the public methods that the staff considers acceptable for use in implementing specific parts of the agencys regulations, to explain techniques that the staff uses in evaluating specific problems or postulated events, and to provide guidance to applicant
ITAAC Closure Process


====s. Regulatory ====
General Description of Public Hearing Opportunity


RG 1.215, Rev.2, Page 2 guides are not substitutes for regulations and compliance with them is not required. Methods and solutions that differ from those set forth in RGs are acceptable if they provide a basis for licensing or other regulatory findings by the Commission.
RG 1.215, Page 3


Paperwork Reduction Act
Summary Description of 10 CFR 52.103 Process and Fuel Load Authorization Process


This RG contains information collection requirements covered by 10 CFR Part 52 (Licenses, Certifications, and Approvals for Nuclear Power Plants) that the Office of Management and Budget (OMB) approved under OMB control number 3150-0151. The NRC may neither conduct nor sponsor, and a person is not required to respond to, an information collection request or requirement unless the requesting document displays a currently valid OMB control number.
*
Schedule Considerations for ITAAC-Related Activities and Coordination to Support NRC Inspection Planning


==B. DISCUSSION==
Proprietary Construction Schedule Information
Reason for Revision


This revision (Revision 2) of RG 1.215 approves for use Nuclear Energy Institute (NEI) 08-01, Industry Guideline for the ITAAC Closure Process under 10 CFR Part 52, Revision 5 - Corrected (Ref. 2), subject to certain exceptions and additional guidance described in this regulatory guide under Section C, Staff Regulatory Guidance. NEI 08-01, Revision 5 - Corrected, was updated to include additional guidance related to ITAAC maintenance, lessons learned from simulated ITAAC closure implementation, changes to the information and formatting guidance for uncompleted ITAAC
Licensee Schedule Coordination
notifications, and other enhancements. The revised industry guidelines also contain additional examples of ITAAC closure notifications (ICNs) that were discussed during numerous public meetings between the NRC and industry.


The original version of this RG was issued in October 2009 (Ref. 3), and approved for use NEI
*
08-01, Revision 3, issued January 2009 (Ref. 4). NEI 08-01 provided generic guidance for the ITAAC
Licensee Process for Review and Preparation of ITAAC Closure Letters
closure program for new nuclear plants licensed under 10 CFR Part 52, and was developed following discussions with the NRC during the period 2007 to 2008. The document provided a common framework and understanding of the 10 CFR Part 52 ITAAC closure process to all stakeholders. Revision 1 of this RG, issued May 2012 (Ref. 5), approved for use NEI 08-01, Revision 4, issued July 2010 (Ref. 6).
Revision 4 included additional guidance related to maintaining the validity of ITAAC conclusions following the submittal of ICNs in support of the final ITAAC finding required by 10 CFR 52.103(g) that all acceptance criteria are met.


The current revision of NEI 08-01 has numerous changes and additions from the 2010 version.
Guidance for Oversight of ITAAC Closure Activities and Maintenance of Records


The first of these changes are updates to and additional definitions in Section 2 of the document. The second set of changes relate to ITAAC maintenance and include the following:  (1) changes to conform to the final ITAAC maintenance rule and the guidance in RG 1.215, Rev. 1, (2) guidance on ITAAC
Standard Format for ITAAC Closure Packages
maintenance for Design Acceptance Criteria (DAC) and Design Reliability Assurance Program (D-RAP)
ITAAC, and (3) revisions to several ITAAC maintenance examples in Appendix H. The third change in the latest revision of NEI 08-01 is the modification of existing ITAAC closure notification guidance and examples to reflect lessons learned regarding content expectations for ITAAC closure notifications. The fourth change is the addition of new ITAAC closure notification examples to cover additional technical areas related to ITAAC. The fifth set of changes is to the information and formatting guidance for uncompleted ITAAC notifications.  After these changes, the format of uncompleted ITAAC notifications better match the format of ITAAC closure notifications, which will make it easier for readers to compare an uncompleted ITAAC notification with a later ITAAC closure notification on the same ITAAC. Also, the uncompleted ITAAC notifications now focus more on the methods for completing the ITAAC than on


RG 1.215, Rev.2, Page 3 the schedule for completing ITAAC activities. Furthermore, the NRC staff has accepted NEIs proposal to use ITAAC closure notification examples to inform the content expectations for uncompleted ITAAC
Licensee Problem Identification and Resolution Program
notifications because the revised and improved ITAAC closure notification examples meet the specific procedures and analytical methods standard for uncompleted ITAAC notifications.


The sixth set of changes adds guidance on the kind of D-RAP ITAAC that is acceptable for inclusion in a COL, on methods for closing such ITAAC, and on the relationship between D-RAP ITAAC  
*
closure and engineering design verification inspections. The seventh change adds guidance on the closure of reference ITAAC, i.e., ITAAC that have an entry in the Design Commitment column, but the Inspections, Tests, Analyses and Acceptance Criteria fields contain only a reference to another ITAAC. The eighth change is a revised discussion on licensee practices for compiling ITAAC completion packages. The ninth change is the addition of guidance on mitigating and managing issues associated with the large number of ITAAC that are expected to be completed in the last year of construction. The tenth change is the incorporation of guidance in RG 1.215, Revision 1, on the topics of sensitive information in ITAAC notifications and partial ITAAC closure notifications.
Guidance on Sufficient Information for ITAAC Closure Letters
*
Guidance on Sufficient Information for 225-Day Notification of Uncompleted ITAAC  
*
Special Topics


Background 
Maintaining the Validity of ITAAC Conclusions Post-ITAAC Completion


The regulation 10 CFR 52.99 includes requirements for documenting and reporting that the inspections, tests, and analyses have been performed and that the acceptance criteria for each ITAAC  
Criteria/Process for Withdrawal or Update of 10 CFR 52.99 ITAAC Completion Notices
contained in a COL are met. It also sets forth requirements for notifying the NRC of uncompleted ITAAC, of potential changes in the completion status of ITAAC previously reported to the NRC as being met, and when all ITAAC are complete.
 
Design Acceptance Criteria
 
Subsequent COL ITAAC Closure
 
Non-ITAAC Systems
 
*
Acronyms
*
Appendix AExcerpts from 10 CFR Part 52
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Appendix BReserved
*
Appendix CGeneral Description of Common ITAAC Acceptance Criteria Categories
*
Appendix DList of ITAAC Closure Letter Examples
*
Appendix EList of 225-Day Notification Examples


This RG provides guidance on licensee notifications to the NRC for completed and uncompleted ITAAC, post-closure notifications on ITAAC maintenance activities, and notifications declaring that the licensee has completed all ITAAC contained in the COL. The NRC uses these notifications to determine whether the licensee has successfully completed ITAAC, to verify that acceptance criteria are met, to facilitate public participation in the ITAAC hearing process, and to plan inspections. This RG, through its approval for use of an industry guidance document, describes methods that the NRC staff considers acceptable for licensees to use for documenting, reporting, and maintaining the satisfactory completion of the ITAAC in the COL as required by10 CFR 52.99.
2.


Types of ITAAC Notifications 
Guidelines on ITAAC Closure Development and Documentation in NEI 08-01


The regulation 10 CFR 52.99 requires licensees to submit several types of ITAAC notifications to the NRC. The first type of ITAAC notification (ITAAC closure notification) must be submitted by the licensees in accordance with 10 CFR 52.99(c)(1). The ITAAC closure notification must inform the NRC
The staff endorses NEI 08-01, Revision 3, as an acceptable method of complying with the requirements of 10 CFR 52.99, subject to the comments below. NEI 08-01 provides guidance for licensees on major aspects of the ITAAC closure process in the following sections:
of the basis for the licensees determination that it has successfully completed an ITAAC. ITAAC closure notifications must be submitted for all ITAAC, with the exception of those ITAAC resolved at COL
issuance under 10 CFR 52.97(a)(2). The second type of ITAAC notification, an ITAAC post-closure notification (formerly referred to as a supplemental ITAAC closure notification) is governed by
10 CFR 52.99(c)(2) and would apply to ITAAC for which an ITAAC closure notification has previously been submitted. This notification would result from the occurrence and resolution of an event that materially altered the basis for determining that a prescribed inspection, test, or analysis was performed as required, or for finding that a prescribed acceptance criterion is met. This ITAAC post-closure notification would describe the resolution of the circumstances surrounding the identification of new material information, and would need to contain sufficient information to demonstrate that, notwithstanding the new information, the prescribed inspections, tests, or analyses have been performed as required and the prescribed acceptance criteria are met. The third type of ITAAC notification (uncompleted ITAAC notification) must be submitted by licensees in accordance with


RG 1.215, Rev.2, Page 4
Section 1 of NEI 08-01 provides an introduction to the document, a description and purpose of ITAAC, and the scope of topics that it will cover.
10 CFR 52.99(c)(3) at least 225 days before the scheduled initial loading of fuel. An uncompleted ITAAC  
notification must describe how the licensee will successfully complete all uncompleted ITAAC before fuel is loaded. The final type of notification under 10 CFR 52.99(c)(4) informs the NRC that the licensee has successfully completed all ITAAC in the COL.


Definitions and Terminology in NEI 08-01 for ITAAC Notifications
Section 2 of NEI 08-01 provides a list of definitions for terminology used in the guide.  Some of these definitions will reappear in other documents such as combined license applications, design


Section 2 of NEI 08-01 provides a list of definitions for terminology. Some of these definitions will reappear in other documents, such as COL applications, design certification applications, and other supporting documents. However, the COL licensees referencing the design certification are, of course, bound by the definitions in the design certification rather than by the definitions in NEI 08-01, unless they seek an exemption from the Tier 1 definition. The NRC staff believes that the NEI 08-01 definitions could form the basis for a Tier 1 definition in future design certifications, design certification amendments, and plant-specific exemptions to already certified designs.
RG 1.215, Page 4 certification applications, and other supporting documents. Currently certified designs have the following definition for as-built:


Appendices to this Regulatory Guide
As-built means the physical properties of the structure, system, or component following the


Appendix A to this RG is derived from Enclosure 1 to SECY-10-0100, Staff Progress in Resolving Issues Associated with Inspections, Tests, Analyses, and Acceptance Criteria, dated August 5, 2010 (Ref. 7). Enclosure 1 to SECY-10-0100 presents a detailed discussion of when a license amendment is required in the ITAAC maintenance context. Although Sections 3.2, 8.1, and 8.2 of NEI
completion of its installation or construction activities at its final location at the plant site.
08-01 discuss the need for license amendments and exemptions in the ITAAC context, Appendix A to this RG is a more detailed discussion specifically focused on issues associated with ITAAC maintenance.


Appendix B to this RG contains a flowchart and description for the implementation of
NEI 08-01 defines as-built as follows:
10 CFR 52.99 and 10 CFR 52.103(g) that the staff developed, as described in Enclosure 3 of SECY-08-0117, Staff Approach To Verify Closure of Inspections, Tests, Analyses, and Acceptance Criteria and To Implement Title 10 CFR 52.99, Inspection during Construction, and Related Portion of
10 CFR 52.103(g) on the Commission Finding, dated August 7, 2008 (Ref. 8). This flowchart has been updated to reflect developments since SECY-08-0117. The process flowchart blocks are accompanied by numbered descriptions to further delineate each major milestone in the regulatory process for ITAAC
closure and verification, up to and including the 10 CFR 52.103(g) finding.


Harmonization with International Standards
As-built means the physical properties of a structure, system, or component following the completion of its installation or construction activities at its final location at the plant site.  Determination of physical properties of the as-built structure, system, or component may be based on measurements, inspections, or tests that occur prior to installation, provided that subsequent fabrication, handling, installation, and testing do not alter the properties.


The NRC staff reviewed guidance from the International Atomic Energy Agency (IAEA),
COL licensees referencing already-certified designs are, of course, bound by the definitions in the design certification rather than the definitions in NEI 08-01, but the NRC staff believes that the NEI 08-
International Organization for Standardization (ISO), and International Electrotechnical Commission (IEC) and did not identify any standards that provide useful guidance to NRC staff, applicants, or licensees on ITAAC notifications, which is a regulatory concept unique to the U.S., and therefore is not within the scope of IAEA activities, the ISO or the IES.
01 definition of as-built could form part of the basis for a DCD definition of as-built in future design certifications and design certification amendments. Any such DCD definition, however, should also reflect the additional discussion in NEI 08-01 Section 3.1.4. The second paragraph of NEI 08-01 Section
3.1.4 states:


Documents Discussed in Staff Regulatory Guidance
Many ITAAC require verification of as-built SSCs.  However, some of these ITAAC will involve measurements and/or testing that can only be conducted at the vendor site due to the configuration of equipment or modules or the nature of the test (e.g., measurements of reactor vessel internals).  For these specific items where access to the component for inspection or test is impractical after installation in the plant, the ITAAC closure documentation (e.g., test or inspection record) will be generated at the vendor site and provided to the licensee.


This RG approves for use, in part, a third-party guidance document. This third-party guidance document may contain references to other codes, standards or third party guidance documents (secondary references). If a secondary reference has itself been incorporated by reference into NRC
As-built inspections, tests, and analyses of ITAAC SSCs should ordinarily be performed after installation and construction activities at the final location at the plant site.  Section 3.1.4 of NEI 08-01 acknowledges that it may be impractical to perform some inspections and testing after installation in the plant.  In those cases, it may be appropriate to perform inspections or tests prior to final installation (e.g.,
regulations as a requirement, then licensees and applicants must comply with that standard as set forth in the regulation. If the secondary reference has been endorsed in an RG as an acceptable approach for meeting an NRC requirement, then the standard constitutes a method acceptable to the NRC staff for meeting that regulatory requirement as described in the specific RG. If the secondary reference has neither been incorporated by reference into NRC regulations nor endorsed in an RG, then the secondary
measuring an interior dimension prior to final assembly of a valve).  


RG 1.215, Rev.2, Page 5 reference is neither a legally-binding requirement nor a generic NRC approved acceptable approach for meeting an NRC requirement. However, licensees and applicants may consider and use the information in the secondary reference, if appropriately justified, consistent with current regulatory practice, and consistent with applicable NRC requirements.
Section 3 of NEI 08-01 provides a general description of the role of the ITAAC process in Subpart A, Early Site Permits; Subpart B, Standard Design Certifications; and Subpart C, Combined Licenses, of 10 CFR Part 52. The ITAAC closure process described in NEI 08-01 is consistent with
10 CFR 52.99 requirements for verifying that the construction of a new nuclear plant matches the certified design and the additional criteria listed in the combined license.  The discussion on sufficient information further describes the notification letters as required by 10 CFR 52.99(c)(1) and  
10 CFR 52.99(c)(2).  Section 3 also discusses public hearing opportunities during construction and provides a summary description of the process under 10 CFR 52.103, Operation under a Combined License and its associated fuel load authorization process.


C.  STAFF REGULATORY GUIDANCE
Section 4 of NEI 08-01 provides information on schedule considerations for ITAAC-related activities and coordination to support NRC inspection planning.  In accordance with 10 CFR 52.99, the licensee is required to submit an ITAAC closure schedule at 6-month intervals during plant construction.


1.
RG 1.215, Page 5 Within 1 year of fuel load, that interval will decrease to 30 days.  The licensees ITAAC closure schedule will allow the NRC staff to plan its oversight activities of onsite and offsite construction inspections.  The NRC will consider any licensee claims that the submitted schedule is proprietary and should be withheld from public release under the Freedom of Information Act and 10 CFR 2.390 (Ref. 4).  


Use of NEI 08-01  
Section 5 of NEI 08-01 provides guidance on the licensee process for preparation and review of ITAAC closure letters.  This section also provides guidance for licensee oversight of ITAAC closure activities and the maintenance of records referenced by the ITAAC closure packages.  Section 5 also provides an outline of closure letters.  This outline is further detailed in the templates contained in Appendix D to NEI 08-01.  Section 5 includes a discussion of a licensees problem identification and resolution (PI&R) program addressing the identification and correction of deficiencies and the prevention of their recurrence as they relate to ITAAC completion.


The NRC staff considers the methods discussed in NEI 08-01, Revision 5 - Corrected, to be acceptable for complying with the provisions of 10 CFR 52.99, with the exceptions and additional guidance discussed below. The NEI 08-01 guidance for ITAAC closure notification development is considered to be applicable to all ITAAC, regardless of whether the source of the ITAAC is a generic design certification or a site-specific application. Operation (which includes loading fuel)
Section 6 of NEI 08-01 provides guidance on the amount of information that must be contained in ITAAC closure letters. ITAAC closure letters must contain sufficient information to allow the NRC to determine whether the ITAAC have been successfully completed. According to the SOC for the 2007 Part 52 Rule, the closure letters mandated by 10 CFR 52.99(c)(1) must also include sufficient information so that interested persons will have access to information on completed ITAAC at a level of detail sufficient to address the Atomic Energy Act of 1954, Section 189.a(1)(B), threshold for requesting a hearing on whether the acceptance criteria have been, or will be, met. (Ref. 3). 
cannot commence until the NRC finds under 10 CFR 52.103(g) that all acceptance criteria in the COL are met.


a. As stated in NEI 08-01 Section 3.1.2, licensees should document ITAAC completion under their Quality Assurance (QA) program because ITAAC have special regulatory significance under 10 CFR Part 52. Licensees should refer to NUREG-0800, Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition, Chapter 17, Quality Assurance, Section 17.5, Nonsafety-Related SSC Quality Controls, (Ref. 9) for guidance on QA use during the construction and installation of SSCs. In particular, the licensee should adopt a graded QA approach for the completion of NSR ITAAC and ITAAC
The NRC expects the notification of ITAAC completion to contain more information than just a simple statement that the licensee has completed the ITAAC and has met the acceptance criteria. The NRC expects the notification to be sufficiently complete and detailed for a reasonable person to understand the bases for the licensees representation that it has successfully completed the inspections, tests, and analyses and has met the acceptance criteria. The term sufficient information requires, at a minimum, a summary description of the bases for the licensees conclusion that it has performed the inspections, tests, or analyses and that it has met the prescribed acceptance criteria (Ref. 3).  
associated with the regulatory treatment of NSR systems.


b. The NRC expects to issue COLs which include an appendix that contains a complete, integrated list of ITAAC for each licensed unit, drawn from the design control document, early site permit (ESP), limited work authorization (LWA), and COL application, as applicable. The NRC expects that licensees will submit ITAAC closure notifications using the nomenclature and numbering scheme of the ITAAC identified in the COL. This will minimize errors and ensure consistent referencing of specific ITAAC by the licensee, the NRC, and the public. The COL ITAAC appendix is considered to be the appropriate reference since it is possible that the site-specific ITAAC could differ from the design certification document (DCD) ITAAC. This clarification is needed because some of the ITAAC notification examples identify the ITAAC as coming from a particular certified design. For the same reason, when the ITAAC notification refers to a table in the ITAAC, the reference should not be to the DCD, but should be to the table in the ITAAC appendix in the license.
Each 10 CFR 52.99(c)(1) submittal should include sufficient information on the attributes that validate that the licensee has satisfied the acceptance criteria. The licensee should copy the ITAAC  
directly from the certified design and COL to the ITAAC statement. The ITAAC determination basis should include a clearly written, detailed process for how the licensee completed the inspections, tests, or analyses and should explain how the acceptance criteria have been met.  Each inspection, test, or analysis should be detailed to clearly indicate how it was completed and should state its results. The results should then be compared to the acceptance criteria and should include the bases for the licensees conclusion that the acceptance criteria have been met. The submittal should also include ITAAC-related construction findings related to the ITAAC and their closure status, confirmation from the licensees official representative that the licensee has met the acceptance criteria, and a list of references applicable to the ITAAC and available for NRC review.  Appendix D to NEI 08-01 presents examples of ITAAC closure letters.


c. All notifications on an ITAAC under 10 CFR Part 52.99 should include the ITAAC Index number and ITAAC Section number assigned to the ITAAC in the COL as part of the subject line. For example, the subject line for all submitted ICNs should state ITAAC Closure Notification on Completion of {Site Name, Unit No., ITAAC Section No., and ITAAC Index No.}. When the licenses are issued, the ITAAC are contained in an appendix to the COL and each ITAAC is given an index number that ranges from 1 to the number of ITAAC in the COL (e.g., 875 for Vogtle Unit 3). The Index number format simplifies the future identification of all notifications made on a given ITAAC in a COL. It should be noted that due to possible additions, deletions, and changes to ITAAC after COL issuance, there may not be a direct correlation between the highest ITAAC index number and the total number of
Section 7 of NEI 08-01 provides guidance on sufficient information for the 225-day notification of uncompleted ITAAC.  The 225-day notification mandated by 10 CFR 52.99(c)(2) must include sufficient information so that interested persons will have access to information on uncompleted ITAAC  
at a level of detail sufficient to address the Atomic Energy Act of 1954, Section 189.a(1)(B), threshold for requesting a hearing on whether the acceptance criteria have been, or will be, met (Ref.3). In addition, this requirement will aid the staff in determining if the licensee will be able to satisfy the acceptance


RG 1.215, Rev.2, Page 6 ITAAC in a COL. The ITAAC Section number is the number assigned to the ITAAC in regard to the section of the ITAAC appendix of a COL in which the ITAAC appears.
RG 1.215, Page 6 criteria for a given ITAAC. The uncomplete notification will be a predictive summary for how the licensee plans to complete the ITAAC if that ITAAC is not completed by 225 days before scheduled fuel load.


d. In numerous ICN examples, the determination basis simply refers to an endorsed or approved code (e.g. ASME Section III). While not required, citing the specific relevant code section(s)
The licensee must demonstrate that it will comply with the ITAAC, and it must provide sufficient information to demonstrate that it will perform the prescribed inspections, tests, or analyses and will meet the prescribed acceptance criteria for the uncompleted ITAAC. The term sufficient information requires, at a minimum, a summary description of the bases for the licensees conclusion that it will perform the inspections, tests, or analyses and that it will meet the prescribed acceptance criteria (Ref. 3).
or article(s) used in performing the ITAAC can facilitate the staffs review of the ICN.
In addition, sufficient information includes, but is not limited to, a description of the specific procedures and analytical methods that the licensee will use to perform the inspections, tests, and analyses and to determine that it has met the acceptance criteria (Ref. 2).  


In addition, if the code or article has been endorsed by an RG, the RG should be referenced, especially if there are specific conditions or restrictions on the use of the code or article (e.g.,
Each 10 CFR 52.99(c)(2) notification should include sufficient information for both the completed and uncompleted elements of the ITAAC.  The licensee should copy the ITAAC directly from the certified design and COL to the ITAAC statement.  Items that the licensee has completed toward ITAAC closure should be accompanied by a clearly written, detailed process for how the licensee completed those portions of the inspections, tests, or analyses.  Items that remain uncomplete for ITAAC
use of ASME Code XXX is conducted as accepted in RG 1.YYY).  
closure should be accompanied by a clearly written, detailed process for how the licensee expects to complete those portions of the inspections, tests, or analyses and subsequently conclude that the acceptance criteria will be met. Each inspection, test, or analysis for both completed and uncompleted portions should be detailed to clearly indicate how it was, or will be, completed. The submittal should also include a schedule for completing the ITAAC and a list of references applicable to the ITAAC and available for NRC review. Appendix E to NEI 08-01 presents examples of uncomplete notifications.


e. Although there is no current guidance in NEI 08-01 for the content of the 10 CFR 52.103(a)
Section 8 of NEI 08-01 provides a discussion on special topics, including acceptance criteria preservation for closed ITAAC, withdrawals or updates to 10 CFR 52.99 completion notices, design acceptance criteria (DAC) procedures, subsequent COL ITAAC closure, and non-ITAAC systems.
scheduled fuel load notification, the staff provides the following: The initial notification should include the anticipated date (270 days in the future) of initial loading of fuel. The updates required by 10 CFR 52.103, Operation under a combined license, should include updates to the anticipated date, if applicable. In determining the anticipated date, the licensee should use NRC guidance on timeframes for the NRCs completion of its review and the making of the 10 CFR 52.103(g) finding. This NRC guidance will be developed in the future.


f. The design and configuration control program should include an assessment and evaluation that confirm that the ITAAC potentially affected by a proposed change are still valid and that assure the functionality originally intended.
Section 52.103(g) states, The licensee shall not operate the facility until the Commission makes a finding that the acceptance criteria in the combined license are met.  Following the completion of any ITAAC,
the licensee must maintain the validity of the acceptance criteria of the closed ITAAC to demonstrate that this requirement is met.  One proposed method that the licensee can use to meet this requirement is to include provisions in approved programs such as the quality assurance program, the maintenance program, the problem identification and resolution program, and the design and configuration control program.  These provisions should include licensee plans and programs to ensure that the maintenance of items such as structures, systems, or components that are included in ITAAC does not invalidate the conclusion that the acceptance criteria are met.


g. As described above, Appendix A to this RG includes a detailed discussion of when a license amendment is required in the ITAAC maintenance context.
Withdrawals or updates to a 10 CFR 52.99(e)(1) Federal Register posting are possible if a material error or omission is found to affect the validity of a licensees 10 CFR 52.99(c)(1) notification after it has made the notification.


2.
DAC are a subset and special type of ITAAC. In SECY-92-053 (Ref. 5), Use of Design Acceptance Criteria During 10 CFR Part 52 Design Certification Reviews, DAC were defined by the staff to address design areas that rapidly change or for which sufficient as-built (or, as procured)  information is unavailable to support design analysis.  For example, digital instrumentation and control (I&C) is a rapidly changing design area and freezing its associated design details early in a design certification stage


Use of Examples in NEI 08-01
RG 1.215, Page 7 could make implementation of the certified design impractical for holders of a combined license, as the final I&C design and installation would be completed years after the design certification was completed.


NEI 08-01 includes examples for notifications required by 10 CFR 52.99. Although these examples are intended to illustrate and reinforce the guidance in NEI 08-01, the licensee should not consider the NRCs endorsement of this industry guideline document a determination that each example applies to all licensees as it is presented and written in the guide, but rather as an example of what constitutes sufficient information for the ITAAC presented. A licensee should ensure that an example applies to its particular circumstances before implementing it. The sufficient information, required by 10 CFR 52.99(c)(1), for any individual ITAAC closure notification can only be generically guided by the examples presented in NEI 08-01, Revision 5 -
DAC set forth the processes and acceptance criteria for completing design detail. DAC can be resolved through three different options: (1) an amendment to the design certification (generic), (2) a submittal as part of the combined license application (plant-specific), and (3) closure of the DAC during construction (plant-specific). The NRC staff prefers to resolve DAC through the amendment of the design certification rule or resolve DAC through the COL application review process, because these two scenarios would be completed before construction begins.
Corrected. Ultimately, sufficient information must be determined with respect to the specific facts surrounding each ITAAC performance and closure.


RG 1.215, Rev.2, Page 7
As-built ITAAC will be used to demonstrate that the as-built facility conforms to the completed DAC. As-built ITAAC will be resolved as part of the ITAAC closure process.  The successful completion of the as-built ITAAC will be documented through the ITAAC completion documentation process described in NEI 08-01.


==D. IMPLEMENTATION==
The DAC review and inspection process is currently being developed.  Detailed guidance on NRC review and inspection of DAC will be documented as appropriate when complete. Types of documents being considered include an inspection manual chapter, the standard review plan, or other suitable guidance.
The purpose of this section is to provide information on how applicants and licensees1 may use this guide and information regarding the NRCs plans for using this RG. In addition, it describes how the NRC staff complies with 10 CFR 50.109, Backfitting, and any applicable finality provisions in 10 CFR
Part 52.


Use by Applicants and Licensees
ITAAC closure might involve closure letters that are common to each licensee of a particular design.  After the initial closure letter on a common issue is submitted, subsequent licensees could submit letters referencing identical information, but this would not apply to acceptance criteria that require field activities.


Applicants and licensees may voluntarily2 use the guidance in this document to demonstrate compliance with the underlying NRC regulations. Methods or solutions that differ from those described in this RG may be deemed acceptable if they provide sufficient basis and information for the NRC staff to verify that the proposed alternative demonstrates compliance with the appropriate NRC regulations.
Non-ITAAC systems might not have design commitments specifically listed under its system title but, in some cases, have design commitments listed under another system title.


Current licensees may continue to use guidance the NRC found acceptable for complying with the identified regulations as long as their current licensing basis remains unchanged.
Section 9 of NEI 08-01 provides a list of acronyms used in the guide.


Licensees may use the information in this RG for actions that do not require NRC review and approval such as changes to a facility design under 10 CFR 50.59, Changes, Tests, and Experiments.
Appendix A to NEI 08-01 provides excerpts from 10 CFR Part 52 that are applicable to the guidelines areas of discussion.


Licensees may use the information in this RG or applicable parts to resolve regulatory or inspection issues.
Appendix B to NEI 08-01 is reserved for future use.


Use by NRC Staff 
Appendix C to NEI 08-01 provides a general description of common ITAAC categories and includes discussions of categories such as calculations and analyses, test procedures, special processes, inspection program, American Society of Mechanical Engineers code design reports, existing reports that conclude that acceptance criteria are met, procurement, material control, and training and qualification.


The NRC staff does not intend or approve any imposition or backfitting of the guidance in this RG. The NRC staff does not expect any existing licensee to use or commit to using the guidance in this RG, unless the licensee makes a change to its licensing basis. The NRC staff does not expect or plan to request licensees to voluntarily adopt this RG to resolve a generic regulatory issue. The NRC staff does not expect or plan to initiate NRC regulatory action that would require the use of this RG. Examples of such unplanned NRC regulatory actions include issuance of an order requiring the use of the RG, requests for information under 10 CFR 50.54(f) as to whether a licensee intends to commit to use of this RG,
These discussions are intended to assist the licensee in preparing closure letters or uncomplete notifications for each type of ITAAC category.
generic communication, or promulgation of a rule requiring the use of this RG without further backfit consideration.


During regulatory discussions on plant-specific operational issues, the staff may discuss with licensees various actions consistent with staff positions in this RG, as one acceptable means of meeting the underlying NRC regulatory requirement. Such discussions would not ordinarily be considered backfitting even if prior versions of this RG are part of the licensing basis of the facility. However, unless this RG is part of the licensing basis for a facility, the staff may not represent to the licensee that the licensees failure to comply with the positions in this RG constitutes a violation.
Appendix D to NEI 08-01 provides the set of ITAAC closure letters that were prepared during the workshops and public meetings in 2007 and 2008.


If an existing licensee voluntarily seeks a license amendment or change and (1) the NRC staffs consideration of the request involves a regulatory issue directly relevant to this new or revised RG and  
Appendix E to NEI 08-01 provides the set of 225-day notifications that were also prepared during the workshops and public meetings in 2007 and 2008.  Licensees can use these templates to submit
(2) the specific subject matter of this RG is an essential consideration in the staffs determination of the  
10 CFR 52.99(c)(1) and 10 CFR 52.99(c)(2) letters.  Each template contains a statement of the full


1 In this section, licensees refers to licensees of nuclear power plants under 10 CFR Parts 50 and 52; and applicants, refers to applicants for licenses and permits for (or relating to) nuclear power plants under 10 CFR Parts 50 and 52, and applicants for standard design approvals and standard design certifications under 10 CFR Part 52.
RG 1.215, Page 8 ITAAC as it is included in the COL or certified reactor design, a section describing the bases for considering the ITAAC complete, a section for an ITAAC-related construction finding review, and a closure statement followed by a licensee representative signature for each submittal.  Licensees must submit a 10 CFR 52.99(c)(2) notification for each uncompleted ITAAC by the 225-day milestone before scheduled fuel load.  The 225-day notification requires additional detail on items completed toward ITAAC closure and on items that must be completed in the time before the 10 CFR 52.103(g) finding.


2 In this section, voluntary and voluntarily mean that the licensee is seeking the action of its own accord, without the force of a legally binding requirement or an NRC representation of further licensing or enforcement action.
The staff considers these letters to be examples and anticipates that differing or additional information, consistent with Section 6 of NEI 08-01 (Guidance on Sufficient Information for ITAAC Closure Letters),  
may be necessary for individual ITAAC letters.  Licensees should review the criteria of Sections 6 and 7 of NEI 08-01 to determine the appropriate content.


RG 1.215, Rev.2, Page 8 acceptability of the licensees request, then the staff may request that the licensee either follow the guidance in this RG or provide an equivalent alternative process that demonstrates compliance with the underlying NRC regulatory requirements. This is not considered backfitting as defined in
3.
10 CFR 50.109(a)(1) or a violation of any of the issue finality provisions in 10 CFR Part 52.


Additionally, an existing applicant may be required to comply with new rules, orders, or guidance if 10 CFR 50.109(a)(3) applies.
Appendices to This Regulatory Guide


If a licensee believes that the NRC is either using this RG or requesting or requiring the licensee to implement the methods or processes in this RG in a manner inconsistent with the discussion in this Implementation section, then the licensee may file a backfit appeal with the NRC in accordance with the guidance in NUREG-1409, Backfitting Guidelines, (Ref. 10) and the NRC Management Directive 8.4, Management of Facility-Specific Backfitting and Information Collection (Ref. 11).  
Appendix A to this regulatory guide contains the text of 10 CFR 52.99.


RG 1.215, Rev.2, Page 9 REFERENCES1
Appendix B to this regulatory guide contains the flowchart and description for the implementation of 10 CFR 52.99 and 10 CFR 52.103(g), which the staff developed for use in public workshops, as described in SECY-08-0117. (Ref. 6)  The process flowchart blocks include numbered descriptions to further delineate each major milestone in the regulatory process of ITAAC closure and verification up to and including the 10 CFR 52.103(g) finding.


==C. REGULATORY POSITION==
1.
1.


U.S. Code of Federal Regulations (CFR), Title 10, Energy, Section 52.99, Inspection during construction; ITAAC schedules and notifications; NRC notices, U.S. Nuclear Regulatory Commission, Washington, DC.
NEI 08-01
 
The NRC staff considers the methods discussed in NEI 08-01, Revision 3, to be acceptable for complying with the provisions of 10 CFR 52.99  


2.
2.


Nuclear Energy Institute (NEI) technical report 08-01, Industry Guideline for the ITAAC
Other Documents Referenced in NEI 08-01 NEI 08-01 references other documents, but this regulatory guide does not endorse any of the referenced documents.
Closure Process under 10 CFR Part 52, Revision 5 - Corrected, Washington, DC, June 2014 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML14182A158).  


3.
3.


U.S. Nuclear Regulatory Commission (NRC) Regulatory Guide (RG) 1.215, Guidance for ITAAC Closure Under 10 CFR Part 52, Revision 0, Washington, DC (ADAMS Accession No. ML091480076).  
Use of Examples in NEI 08-01 NEI 08-01 includes examples for ITAAC closure letter submittals and uncomplete notifications for ITAAC. Although these examples are appropriate as general templates for illustrating and reinforcing the guidance in NEI 08-01, the NRCs endorsement of this industry guideline document should not be considered a determination that each example applies to all licensees as it is presented and written in the guide.  A licensee should ensure that an example applies to its particular circumstances before implementing the guidance, or template, as described.


4.
4.


NEI 08-01, Industry Guideline for the ITAAC Closure Process under 10 CFR Part 52, Revision 3, Washington, DC, January 2009 (ADAMS Accession No. ML090270415).  
Guidance for Site-Specific ITAAC
For licensees who have site-specific ITAAC in their COL, the guidance in NEI 08-01 applies to both design certification and site-specific ITAAC closure notification development.


RG 1.215, Page 9
5.
5.


NRC, RG 1.215, Guidance for ITAAC Closure Under 10 CFR Part 52, Revision 1, Washington, DC (ADAMS Accession No. ML112580018).  
Use of Other Methods Licensees may use methods other than those provided in NEI 08-01 to meet the requirements of
10 CFR 52.99.  The staff will review such methods and determine the acceptability of other methods on a case-by-case basis.


6.
==D. IMPLEMENTATION==
The purpose of this section is to provide information to applicants and licensees regarding the NRCs plans for using this regulatory guide.  The NRC does not intend or approve any imposition or backfit in connection with its issuance.


NEI 08-01, Industry Guideline for the ITAAC Closure Process under 10 CFR Part 52, Revision 4, Washington, DC, July 2010 (ADAMS Accession No. ML102010051).  
In some cases, applicants or licensees may propose or use a previously established acceptable alternative method for complying with specified portions of the NRCs regulations.  Otherwise, the methods described in this guide will be used in evaluating compliance with the applicable regulations for ITAAC closure.


7.
REGULATORY ANALYSIS / BACKFIT ANALYSIS


NRC, SECY-10-0100, Staff Progress in Resolving Issues Associated with Inspections, Tests, Analyses, and Acceptance Criteria, Washington, DC, August 5, 2010 (ADAMS Accession No. ML101660706).  
The NRC published a regulatory analysis and a backfit analysis with the draft of this guide when it was originally issued for public comment as Draft Regulatory Guide DG-1204, Guidance for ITAAC
Closure Under 10 CFR Part 52.  The NRC issued DG-1204 in March 2009 to solicit public comment on the draft of this new Regulatory Guide 1.215, but received no comments on the regulatory analysis or backfit analysis.


8.
RG 1.215, Page 10


NRC, SECY-08-0117, Staff Approach To Verify Closure of Inspections, Tests, Analyses, and Acceptance Criteria and To Implement Title 10 CFR 52.99, Inspection During Construction, and Related Portion of 10 CFR 52.103(g) on the Commission Finding, August 7, 2008, Washington, DC (ADAMS Accession No. ML081220237). 
REFERENCES1
1.


9.
NEI 08-01, Industry Guideline for the ITAAC Closure Process under 10 CFR Part 52, Revision 3, January 2009, Nuclear Energy Institute, Washington, DC. ADAMS Accession No. ML090270415


NRC, NUREG-0800, Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition, Washington, DC.
2.


10.
10 CFR Part 52.99, Inspection during construction, U.S. Nuclear Regulatory Commission, Washington, DC.


NRC, NUREG-1409, Backfitting Guidelines, Washington, DC, July 1990 (ADAMS Accession No. ML032230247).  
3.


11.
Final Rule for 10 CFR Part 52 Licenses, Certifications, and Approvals for Nuclear Power Plants, August 28, 2007, 72 FR 49352, U.S. Nuclear Regulatory Commission, Washington, DC.


NRC, Management Directive 8.4, Management of Facility-Specific Backfitting and Information Collection, Washington, DC.
4.


12.
10 CFR Part 2.390, Public inspections, exemptions, requests for withholding, U.S. Nuclear Regulatory Commission, Washington, DC.


NRC Inspection Manual Chapter 2503, Construction Inspection Program: Inspections of Inspections, Tests, Analyses and Acceptance Criteria (ITAAC) Related Work, Washington, DC.
5.


1 Publicly available NRC published documents are available electronically through the NRC Library on the NRCs public Web site at: http://www.nrc.gov/reading-rm/doc-collections/. The documents can also be viewed online or printed for a fee in the NRCs Public Document Room (PDR) at 11555 Rockville Pike, Rockville, MD; the mailing address is USNRC PDR, Washington, DC 20555; telephone (301) 415-4737 or (800) 397-4209; fax (301) 415-3548;
SECY-92-053, Use of Design Acceptance Criteria During 10 CFR Part 52 Design Certification Reviews, U.S. Nuclear Regulatory Commission, Washington, DC.
and e-mail pdr.resource@nrc.gov.


RG 1.215, Rev.2, Page 10
6.
13.
 
NRC Inspection Manual Chapter 2504, Construction Inspection Program  Inspection of Construction and Operational Programs, Washington, DC.
 
14.
 
NRC Inspection Manual Chapter 2514, Light Water Reactor Inspection Program - Startup Testing Phase, Washington, DC.


Appendix A to RG 1.215, Page A-1
SECY-08-0117, Staff Approach to Verify Closure of Inspections, Tests, Analyses, and Acceptance Criteria and to Implement Title 10 CFR 52.99, Inspection During Construction, and Related Portion of 10 CFR 52.103(g) on the Commission Finding, Enclosure 3, Flowchart and Description of Implementation under 10 CFR 52.99 and 10 CFR 52.103(g), 
U.S. Nuclear Regulatory Commission, Washington, DC.


APPENDIX A
1 Publicly available NRC published documents such as Regulations, Regulatory Guides, NUREGs, and Generic Letters
INSPECTIONS, TESTS, ANALYSES, AND ACCEPTANCE CRITERIA
MAINTENANCE THRESHOLDS AND ASSOCIATED LICENSE
AMENDMENTS1


Four thresholds for identifying when activities would materially alter the determination bases for inspections, tests, analyses, and acceptance criteria (ITAAC) are presented below. Following each threshold is a discussion on license amendments that would be necessary beyond the envelope of the threshold. These discussions describe scenarios that pertain to the threshold and state when a license amendment would be necessary.
listed herein are available electronically through the Electronic Reading room on the NRCs public Web site at:


Threshold 1:  Postwork Verification
http://www.nrc.gov/reading-rm/doc-collections/. Copies are also available for inspection or copying for a fee from the


Will the postwork verification (PWV) use a significantly different approach than the original performance of the inspection, test, or analysis (ITA) as described in the original ITAAC notification?
NRCs Public Document Room (PDR) at 11555 Rockville Pike, Rockville, MD; the mailing address is USNRC PDR,


Threshold 1 involves situations in which the occurrence of an event could call into question whether a licensee continues to meet an acceptance criterion (AC). Such situations could involve many types of maintenance activities, including component replacement. After work is complete, a PWV will be used to confirm that the licensee still meets the AC. The PWV is not a performance of the ITA because the licensee has already satisfied the requirement to perform the ITA; instead, the PWV and its results supplement the performance of the ITA to provide confidence that the licensee continues to meet the AC.
Washington, DC 20555; telephone 301-415-4737 or (800) 397-4209; fax (301) 415-3548; and e-mail


The nature and the scope of the PWV will depend upon the nature of the initiating event, the maintenance activities undertaken, and the specific ITAAC that is implicated by the event. If the PWV represents an alternate approach that is significantly different from the approach described in the original ITAAC
PDR.Resource@nrc.gov.
notification, a supplemental notification is necessary to provide the agency and members of the public information that is material to the agencys determination on ITAAC.


Because the PWV is not a performance of the ITA but rather a supplement to the performance of the ITA,
Appendix A to RG 1.215, Page A-1 APPENDIX A  
the PWV does not have to comport with the ITA set forth in the license. However, the licensee would need to seek an amendment to that ITA in the license if no reasonable alternate PWV approach is available to demonstrate that the AC continues to be met. Whether an alternative PWV is reasonable or not depends on several factors, including the engineering justification provided and the wording of both the ITA and the AC. A reasonable alternative to the original ITA represents a different, yet acceptable, engineering equivalent for performing the activity prescribed in the ITAAC. As an example, if a test was the original prescribed ITA, then the PWV should also be a test, or possibly a combination of a test and analysis or a test and an inspection. The PWV methodology should generally follow the methodology used in the original prescribed ITA.


A license amendment would also be necessary if the PWV reveals that the licensee never met the AC
TEXT OF 10 CFR 52.99
because the original ITA, as worded in the license, was flawed.


1 Appendix A to RG 1.215, Revision 2, is taken largely from Enclosure 1 of SECY-10-0100, Staff Progress in Resolving Issues Associated with Inspections, Tests, Analyses, and Acceptance Criteria, August 5, 2010 (ADAMS Accession No.
§ 52.99 Inspection during construction.


ML101660706).  The introductory paragraph has been edited to update its content.  The descriptions of the thresholds replicate those in Enclosure 1 of SECY-10-0100.
(a) The licensee shall submit to the NRC, no later than 1 year after issuance of the combined license or at the start of construction as defined in 10 CFR 50.10(a), whichever is later, its schedule for completing the inspections, tests, or analyses in the ITAAC.  The licensee shall submit updates to the ITAAC schedules every 6 months thereafter and, within 1 year of its scheduled date for initial loading of fuel, the licensee shall submit updates to the ITAAC schedule every 30 days until the final notification is provided to the NRC under paragraph (c)(1) of this section.


Appendix A to RG 1.215, Page A-2 Threshold 2:  Engineering Changes
(b) With respect to activities subject to an ITAAC, an applicant for a combined license may proceed at its own risk with design and procurement activities, and a licensee may proceed at its own risk with design, procurement, construction, and pre-operational activities, even though the NRC may not have found that any one of the prescribed acceptance criteria have been met.


Will an engineering change be made that materially alters the determination that the acceptance criteria are met?
(c)(1) The licensee shall notify the NRC that the prescribed inspections, tests, and analyses have been performed and that the prescribed acceptance criteria have been met.  The notification must contain sufficient information to demonstrate that the prescribed inspections, tests, and analyses have been performed and that the prescribed acceptance criteria have been met.


License amendments would also be necessary if the engineering change results in the need to identify new AC or if the engineering change results in a design for which the AC as written cannot be demonstrated using the original ITAs.
(2) If the licensee has not provided, by the date 225 days before the scheduled date for initial loading of fuel, the notification required by paragraph (c)(1) of this section for all ITAAC, then the licensee shall notify the NRC that the prescribed inspections, tests, or analyses for all uncompleted ITAAC will be performed and that the prescribed acceptance criteria will be met prior to operation.  The notification must be provided no later than the date 225 days before the scheduled date for initial loading of fuel, and must provide sufficient information to demonstrate that the prescribed inspections, tests, or analyses will be performed and the prescribed acceptance criteria for the uncompleted ITAAC will be met, including, but not limited to, a description of the specific procedures and analytical methods to be used for performing the prescribed inspections, tests, and analyses and determining that the prescribed acceptance criteria have been met.


Threshold 3:  Population of Systems, Structures, and Components
(d)(1) In the event that an activity is subject to an ITAAC derived from a referenced standard design certification and the licensee has not demonstrated that the ITAAC has been met, the licensee may take corrective actions to successfully complete that ITAAC or request an exemption from the standard design certification ITAAC, as applicable.  A request for an exemption must also be accompanied by a request for a license amendment under § 52.98(f).
(2) In the event that an activity is subject to an ITAAC not derived from a referenced standard design certification and the licensee has not demonstrated that the ITAAC has been met, the licensee may take corrective actions to successfully complete that ITAAC or request a license amendment under § 52.98(f).


Will there be additional items that need to be verified through the ITAAC?
Appendix A to RG 1.215, Page A-2 (e) The NRC shall ensure that the prescribed inspections, tests, and analyses in the ITAAC are performed.


A license amendment would be needed if there are additional items subject to verification through the existing ITAAC, but the licensee proposes not to perform the ITAs specified in the ITAAC. An amendment would also be required if new or amended ITAAC are needed to cover new items (e.g., the new items are of a different type than those covered in the original ITAAC).  
(1) At appropriate intervals until the last date for submission of requests for hearing under § 52.103(a),  
the NRC shall publish notices in the Federal Register of the NRC staffs determination of the successful completion of inspections, tests, and analyses.


Threshold 4:  Complete and Valid ITAAC Representation
(2) The NRC shall make publicly available the licensee notifications under paragraph (c)(1), and, no later than the date of publication of the notice of intended operation required by § 52.103(a), make available all licensee notifications under paragraphs (c)(1) and (c)(2) of this section.


Will any other licensee activities materially alter the ITAAC determination basis?
[57 FR 60978, Dec. 23, 1992; 72 FR 49536, Aug. 28, 2007; 72 FR 57447, Oct. 9, 2007]


A license amendment would be needed if an update of the determination basis necessitates a change to any portion of ITAAC in the license for reasons not covered under thresholds 1, 2, and 3.
Appendix B to RG 1.215, Page B-1 APPENDIX B
Flowchart and Description of Implementation Under 10 CFR 52.99 and 10 CFR 52.103(g)


Appendix B to RG 1.215, Page B-1 Yes No Yes No No Yes Yes No IMC2504 (Ref. 13)
No Yes No Yes No No Yes Yes No MC2504 MC2503
IMC2503 (Ref.12)
52.99(c)(1) submittal  
52.99(c)(1) submittal  
(9)  
(9)  
52.99(c)(3)  
52.99(c)(2)
Uncompleted ITAAC notification  
Uncomplete ITAAC  
notification  
(7)  
(7)  
Is the ITAAC  
Is the ITAAC  
Line 326: Line 357:
determine ITAAC  
determine ITAAC  
successfully completed?  
successfully completed?  
(10)  
(10)
More than
225 days until fuel load?  (5)  
52.99(c)(1)  
52.99(c)(1)  
submittal   
submittal   
(2)  
(2)  
Yes Tech Specs No ITAAC to be completed by Licensee
Yes Tech Specs No ITAAC to be completed by licensee        (8)  
(8)  
Fuel load and mode change  
Fuel load and mode change  
(21)  
(19)  
Did NRC  
Did NRC  
determine ITAAC  
determine ITAAC  
successfully completed?  
successfully completed?  
(3)  
(3)  
Licensee needs to complete all ITAAC that are found not met and submit closure notifications for each ITAAC    
Licensee needs to complete all ITAAC and submit closure letters for each ITAAC        
(19)  
(17)  
10 CFR 52.103(a) Commission must publish notice of intended operation at least 180 days before scheduled fuel load  
10 CFR 52.103(a) Commission must publish notice of intended operation  
10 CFR 52.99(c)(3) Uncompleted ITAAC notification requirement  
180 days before scheduled fuel load  
10 CFR 52.99(c)(2) Uncomplete ITAAC notification requirement  
225 days before scheduled fuel load  
225 days before scheduled fuel load  
52.103(g)
52.103(g)
Line 348: Line 381:
For a given ITAAC, ITAAC is considered closed  
For a given ITAAC, ITAAC is considered closed  
(11)  
(11)  
FRN of staff determination for individual ITAAC or ITAAC family, as required  
FRN of staff determination for individual ITAAC or ITAAC  
family, as required
(12)  
(12)  
ITAAC considered to be work-in- progress and closure notification not submitted  
ITAAC considered to be work-in- progress and closure letter not submitted  
(6)  
(6)  
Operation ROP  
Operation ROP  
Yes Substantiated information received that invalidates the closed status of any ITAAC (15)  
Yes Substantiated information received that invalidates the closed status of any ITAAC (14)
ITAAC  
Update FRN for affected ITAAC as appropriate (15)  
closure notification resubmitted by Licensee, possibly after rework
ITAAC to be reworked and/or closure letter resubmitted by licensee
(4)  
(4)  
Hearing contentions addressed Timeline of Major Milestones (not to scale)  
Each ITAAC
listed in the combined license Hearing contentions addressed Timeline of Major Milestones (not to scale)  


Licensee use of developed programs to preserve the satisfaction of acceptance criteria of completed ITAAC  
Licensee use of developed programs to preserve the satisfaction of acceptance criteria of completed ITAAC  
(13)  
(13)  
All acceptance criteria are met? (18)  
All acceptance criteria are met? (16)  


52.103(g)  
52.103(g)  
finding  
finding  
(20)
(18)  
Licensee will submit 10 CFR 52.99(c)(2)
notifications to report events materially altering a closed ITAAC, as well as its resolution 
(14)
52.99(c)(4) submittal upon completion of all ITAAC (17)
No Each ITAAC
listed in the combined license Update FRN for affected ITAAC as appropriate (16)
More than
225 days until fuel load?  (5)
cROP
IMC2514 (Ref.14)
APPENDIX B
Flowchart and Description of Implementation under 10 CFR 52.99 and 10 CFR 52.103(g)  


Appendix B to RG 1.215, Page B-2 Process Block Descriptions:  
Appendix B to RG 1.215, Page B-2 Process block descriptions:  


(1)  
(1)  
This is the first decision block for any given inspection, test, analysis, and acceptance criterion (ITAAC). Each ITAAC can enter this block at any time during construction regardless of its completed or uncompleted status for processing through this flowchart.
This is the first decision block for any given inspection, test, analysis, and acceptance criterion (ITAAC), and the licensee needs to assess each ITAAC from the license. Each ITAAC can enter this block at any time during construction regardless of its completed or uncompleted status for processing through this flowchart.


(2)  
(2)  
If (1) is yes, then the licensee must submit an ITAAC Closure Notification (ICN) pursuant to  
If (1) is yes, then the licensee must submit a closure letter pursuant to 10 CFR 52.99(c)(1).   
10 CFR 52.99(c)(1).   


(3)  
(3)  
The NRC performs ITAAC closure verification activities, including direct inspection, engineering reviews, and consideration of licensee performance within an ITAAC family5. Licensee performance within an ITAAC family is taken into consideration for determination of subsequent licensee ITAAC submittals. Yes indicates that the staff has determined that the ITAAC was successfully completed and is closed. No indicates that the ITAAC is not closed and remains uncompleted.
The U.S. Nuclear Regulatory Commission (NRC) will perform ITAAC closure verification activities, including direct inspection, engineering reviews, and consideration of licensee performance within an ITAAC family. Licensee performance within an ITAAC family is taken into consideration for determination of subsequent licensee ITAAC submittals. Yes indicates that the staff has determined that the ITAAC was successfully completed and is closed. No indicates that the ITAAC is not closed and remains uncomplete.


(4)  
(4)  
If (3) is no, the NRC has determined that either the 10 CFR 52.99(c)(1) ICN information is insufficient or that the licensee has not met the acceptance criteria for the given ITAAC. The licensee will either resubmit an ICN that contains sufficient information demonstrating that it has completed the ITAAC, or the licensee will rework the ITAAC and redo the inspections, tests, and analyses. In either case, the licensee will resubmit the 10 CFR 52.99(c)(1) ICN.
If (3) is no, the NRC has determined that either the 10 CFR 52.99(c)(1) closure letter information is insufficient or that the licensee has not met the acceptance criteria for the given ITAAC. The licensee will either need to resubmit a closure letter that contains sufficient information demonstrating that it has completed the ITAAC, or the licensee will need to rework the ITAAC and redo the inspections, tests, and analyses. In either case, the licensee will need to resubmit the 10 CFR 52.99(c)(1) closure letter.


(5)  
(5)  
If (1) is no, the licensee needs to determine if the time to scheduled fuel load is greater than  
If (1) is no, the licensee needs to identify if the time to scheduled fuel load is greater than 225 days. At the 225-day milestone, the licensee is required to submit 10 CFR 52.99(c)(2)  
225 days. At the 225-day milestone, the licensee is required to submit pursuant to
uncomplete ITAAC notifications for those ITAAC not yet completed and the 10 CFR 52.99(c)(1) closure letter not yet submitted.
10 CFR 52.99(c)(3) Uncompleted ITAAC Notifications (UINs) for those ITAAC that are not yet completed and for which the 10 CFR 52.99(c)(1) ICN has not yet been submitted.


(6)  
(6)  
If (5) is yes, there is no 10 CFR 52.99(c)(3) UIN required for this ITAAC, and the ITAAC  
If (5) is yes, there is no 10 CFR 52.99(c)(2) uncomplete notification required for this ITAAC, and the ITAAC under consideration is in the work-in-progress population.
under consideration is in the work-in-progress population.


(7)  
(7)  
If (5) is no, the licensee needs to submit to the NRC a 10 CFR 52.99(c)(3) UIN. This notification should contain sufficient information to demonstrate that the licensee will successfully perform the ITAAC.
If (5) is no, the licensee needs to submit to the NRC a 10 CFR 52.99(c)(2) uncomplete ITAAC notification. This notification needs to contain sufficient information to demonstrate that the licensee will perform the ITAAC.


(8)  
(8)  
Entry here indicates that an individual ITAAC remains in the uncompleted population. Once the licensee concludes that it has met the acceptance criteria, process block (9) is entered.
Entry here indicates that an individual ITAAC remains in the uncomplete population. Once the licensee concludes that it has met the acceptance criteria, process block (9) is entered.


(9)  
(9)  
Upon successfully meeting the acceptance criteria for a given ITAAC, the licensee can submit the  
Upon successfully meeting the acceptance criteria for a given ITAAC, the licensee can submit the 10 CFR 52.99(c)(1) closure letter to the NRC.
10 CFR 52.99(c)(1) ICN to the NRC.


(10)  
(10)  
The NRC will perform ITAAC closure verification activities. This decision block is identical to block (3).  
The NRC will perform ITAAC closure verification activities. This decision block is identical to block (3).  


(11)  
(11)  
If (10) is yes, the NRC staff has determined that the licensee has met the acceptance criteria.
If (10) is yes, the NRC staff has determined that the licensee has met the acceptance criteria.


5 A grouping of ITAAC that are related through similar construction processes, resulting products, and general inspection attributes; the intersection of a row and a column of the ITAAC Matrix.  (SECY-08-117 and NRC
Inspection Manual Chapter 2503, Construction Inspection Program: Inspections of Inspections, Tests, Analyses and Acceptance Criteria (ITAAC) Related Work)
Appendix B to RG 1.215, Page B-3
(12)  
(12)  
The NRC determination that the licensee has successfully completed an ITAAC is published in the Federal Register until the last date for submission of requests for hearings under  
The NRC determination that the licensee has successfully completed an ITAAC is published in the Federal Register until the last date for submission of requests for hearings under  
10 CFR 52.103(a). The NRC can publish a Federal Register notice (FRN) for individual ITAAC  
10 CFR 52.103(a). The NRC can publish a Federal Register notice (FRN) for individual ITAAC (if needed) or multiple ITAAC (such as an entire family). The NRC is not required to publish an FRN after the last date for submission of requests for hearings under 10 CFR 52.103(a).  
(if needed) or multiple ITAAC (such as an entire family). The NRC is not required to publish an FRN after the last date for submission of requests for hearings under 10 CFR 52.103(a).  


(13)  
(13)  
The licensee will apply developed programs, such as quality assurance and maintenance programs, to preserve the satisfaction of acceptance criteria for completed ITAAC and ensure the validity of ITAAC conclusions.
The licensee will apply developed programs such as quality assurance and maintenance to preserve the satisfaction of acceptance criteria for completed ITAAC of applicable structures, systems, and components.


(14)  
(14)  
The licensee will submit 10 CFR 52.99(c)(2) ITAAC Post-Closure Notifications to report an event materially altering a closed ITAAC, as well as its resolution. Reporting thresholds for an event altering a closed ITAAC are described in NEI 08-01 as approved for use by this Regulatory Guide.
Any substantiated information received by the NRC, including allegations, can invalidate the closed status of any ITAAC.


(15)  
(15)  
Any substantiated information received by the NRC, including information gained through inspection activities or allegations, can invalidate the closed status of any ITAAC.
If (14) is yes, then, depending on the severity of the substantiated allegation or information received, the FRN for each affected ITAAC could be updated accordingly.  Also depending on the severity of the situation, the licensee may or may not have options available to act accordingly to preserve the FRN for the affected ITAAC.


(16)  
(16)  
If (15) is yes, then, depending on the severity of the substantiated information received, the FRN for each affected ITAAC could be updated accordingly. Also depending on the severity of the situation, the licensee may or may not have options available to act accordingly to preserve the FRN for the affected ITAAC.
This process block collectively considers if the licensee has met all ITAAC acceptance criteria.


(17)  
(17)
The licensee will submit an All ITAAC Complete notification pursuant to 10 CFR 52.99(c)(4)
If (16) is no, then the licensee needs to complete all ITAAC and ensure that it meets, and continues to meet, all the acceptance criteria for the 10 CFR 52.103(g) finding.
upon completion of all ITAAC in a combined license and confirmation that all acceptance criteria remain met in preparation for the 10 CFR 52.103(g) finding.


(18)  
(18)  
This process block reflects consideration of whether the licensee has met all ITAAC acceptance criteria.
At the time of the 10 CFR 52.103(g) finding, all acceptance criteria must be met, such as when (16) is yes.  Also, this timeline and flowchart do not contemplate an interim operation scenario whereby the Commission could authorize a period of interim operation that would allow the licensee to load fuel before making the 10 CFR 52.103(g) finding, per 10 CFR
52.103(c).  


(19)
(19)  
If (18) is no, then the licensee needs to complete all ITAAC and ensure that it meets, and continues to meet, all the acceptance criteria to support the 10 CFR 52.103(g) finding.
With an affirmative Commission 10 CFR 52.103(g) finding, the licensee will be authorized to load fuel and enter operational status.}}
 
(20)
At the time of the 10 CFR 52.103(g) finding, all acceptance criteria must be met, such as when
(18) is yes. Also, this timeline and flowchart does not cover an interim operation scenario whereby the Commission could authorize a period of interim operation that would allow the licensee to load fuel per 10 CFR 52.103(c).
 
(21)
With the 10 CFR 52.103(g) finding, the licensee will be authorized to load fuel and enter operational status.}}


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Latest revision as of 11:38, 14 January 2025

Guidance for ITAAC Closure Under 10 CFR Part 52
ML091480076
Person / Time
Issue date: 10/31/2009
From:
Office of Nuclear Regulatory Research
To:
Jervey, Richard 301-251-7404
Shared Package
ML091480069 List:
References
DG-1204 RG-1.215
Download: ML091480076 (27)
v • d • e


The NRC issues regulatory guides to describe and make available to the public methods that the NRC staff considers acceptable for use in implementing specific parts of the agency=s regulations, techniques that the staff uses in evaluating specific problems or postulated accidents, and data that the staff needs in reviewing applications for permits and licenses. Regulatory guides are not substitutes for regulations, and compliance with them is not required. Methods and solutions that differ from those set forth in regulatory guides will be deemed acceptable if they provide a basis for the findings required for the issuance or continuance of a permit or license by the Commission.

This guide was issued after consideration of comments received from the public.

Regulatory guides are issued in 10 broad divisionsC1, Power Reactors; 2, Research and Test Reactors; 3, Fuels and Materials Facilities; 4, Environmental and Siting; 5, Materials and Plant Protection; 6, Products; 7, Transportation; 8, Occupational Health;

9, Antitrust and Financial Review; and 10, General.

Electronic copies of this guide and other recently issued guides are available through the NRC=s public Web site under the Regulatory Guides document collection of the NRC=s Electronic Reading Room at http://www.nrc.gov/reading-rm/doc-collections/ and through the NRC=s Agencywide Documents Access and Management System (ADAMS) at http://www.nrc.gov/reading-rm/adams.html, under Accession No. ML091480076.

U.S. NUCLEAR REGULATORY COMMISSION

October 2009 OFFICE OF NUCLEAR REGULATORY RESEARCH

Revision 0

REGULATORY GUIDE

REGULATORY GUIDE 1.215 (Draft was issued as DG-1204, dated March 2009)

GUIDANCE FOR ITAAC CLOSURE UNDER 10 CFR PART 52

A. INTRODUCTION

This guide describes a method that the staff of the U.S. Nuclear Regulatory Commission (NRC)

considers acceptable for use in satisfying the requirements for documenting the completion of inspections, tests, analyses, and acceptance criteria (ITAAC). In particular, this guide endorses the methodologies described in the industry guidance document Nuclear Energy Institute (NEI) 08-01, Industry Guideline for the ITAAC Closure Process Under 10 CFR Part 52, Revision 3, issued January 2009 (Ref. 1), for the implementation of Title 10, Section 52.99, Inspection during construction, of the Code of Federal Regulations (10 CFR 52.99) (Ref. 2).

The NRC issues regulatory guides to describe to the public methods that the staff considers acceptable for use in implementing specific parts of the agencys regulations, to explain techniques that the staff uses in evaluating specific problems or postulated accidents, and to provide guidance to applicants. Regulatory guides are not substitutes for regulations and compliance with them is not required.

This regulatory guide contains information collection requirements covered by 10 CFR Part 52 that the Office of Management and Budget (OMB) approved under OMB control number 3150-0151.

The NRC may neither conduct nor sponsor, and a person is not required to respond to, an information collection request or requirement unless the requesting document displays a currently valid OMB control number.

RG 1.215, Page 2

B. DISCUSSION

Background

10 CFR 52.99 includes requirements for documenting and reporting the satisfaction of the acceptance criteria for each ITAAC in the combined license (COL).

This guide provides guidance on licensee notifications to the NRC for completed and uncompleted ITAAC. The NRC uses these notifications to determine whether ITAAC have been successfully completed, to facilitate public participation in the ITAAC hearing process, and for inspection planning. This regulatory guide describes methods that the NRC staff considers acceptable for licensees to use for documenting and reporting the satisfactory completion of the acceptance criteria for each ITAAC in the COL. This regulatory guide, through its endorsement of an industry guidance document for licensees, provides guidance on complying with the requirements of 10 CFR 52.99.

1.

Development of Industry Guideline Document NEI 08-01

In accordance with 10 CFR 52.97(b), COLs must contain ITAAC that are necessary and sufficient to provide reasonable assurance that the facility has been constructed and will operate in accordance with the license, the Atomic Energy Act, and NRC regulations. After issuance of a COL, a licensee completes all the ITAAC contained in the COL during construction and then submits closure notification letters to the NRC pursuant to 10 CFR 52.99.

Two types of ITAAC notifications from licensees are required by 10 CFR 52.99. The first type of ITAAC notification (ITAAC closure letter) is submitted under 10 CFR 52.99(c)(1) and informs the NRC of the basis for the licensees determination that an ITAAC has been successfully completed.

ITAAC closure letters must be submitted for all ITAAC, with the exception of ITAAC resolved at COL

issuance under 10 CFR 52.97(a)(2). The second type of ITAAC notification (uncomplete ITAAC

notification letter) is submitted under 10 CFR 52.99(c)(2) at least 225 days before scheduled initial fuel load and describes how all uncompleted ITAAC will be successfully completed prior to fuel load.

Operation (which includes loading fuel) cannot commence until the Commission finds under 10

CFR 52.103(g) that all acceptance criteria in the ITAAC are met. To provide a basis for the Commissions finding and to ensure that ITAAC closure notifications contain sufficient information to satisfy 10 CFR 52.99, the licensee can follow industry guideline NEI 08-01.

NEI 08-01 provides guidance for licensees on major aspects of the ITAAC closure process in the following sections:

Introduction

Definitions

General Description of 10 CFR Part 52 and ITAAC Processes

Role of ITAAC in 10 CFR Part 52 Process

ITAAC Closure Process

General Description of Public Hearing Opportunity

RG 1.215, Page 3

Summary Description of 10 CFR 52.103 Process and Fuel Load Authorization Process

Schedule Considerations for ITAAC-Related Activities and Coordination to Support NRC Inspection Planning

Proprietary Construction Schedule Information

Licensee Schedule Coordination

Licensee Process for Review and Preparation of ITAAC Closure Letters

Guidance for Oversight of ITAAC Closure Activities and Maintenance of Records

Standard Format for ITAAC Closure Packages

Licensee Problem Identification and Resolution Program

Guidance on Sufficient Information for ITAAC Closure Letters

Guidance on Sufficient Information for 225-Day Notification of Uncompleted ITAAC

Special Topics

Maintaining the Validity of ITAAC Conclusions Post-ITAAC Completion

Criteria/Process for Withdrawal or Update of 10 CFR 52.99 ITAAC Completion Notices

Design Acceptance Criteria

Subsequent COL ITAAC Closure

Non-ITAAC Systems

Acronyms

Appendix AExcerpts from 10 CFR Part 52

Appendix BReserved

Appendix CGeneral Description of Common ITAAC Acceptance Criteria Categories

Appendix DList of ITAAC Closure Letter Examples

Appendix EList of 225-Day Notification Examples

2.

Guidelines on ITAAC Closure Development and Documentation in NEI 08-01

The staff endorses NEI 08-01, Revision 3, as an acceptable method of complying with the requirements of 10 CFR 52.99, subject to the comments below. NEI 08-01 provides guidance for licensees on major aspects of the ITAAC closure process in the following sections:

Section 1 of NEI 08-01 provides an introduction to the document, a description and purpose of ITAAC, and the scope of topics that it will cover.

Section 2 of NEI 08-01 provides a list of definitions for terminology used in the guide. Some of these definitions will reappear in other documents such as combined license applications, design

RG 1.215, Page 4 certification applications, and other supporting documents. Currently certified designs have the following definition for as-built:

As-built means the physical properties of the structure, system, or component following the

completion of its installation or construction activities at its final location at the plant site.

NEI 08-01 defines as-built as follows:

As-built means the physical properties of a structure, system, or component following the completion of its installation or construction activities at its final location at the plant site. Determination of physical properties of the as-built structure, system, or component may be based on measurements, inspections, or tests that occur prior to installation, provided that subsequent fabrication, handling, installation, and testing do not alter the properties.

COL licensees referencing already-certified designs are, of course, bound by the definitions in the design certification rather than the definitions in NEI 08-01, but the NRC staff believes that the NEI 08-

01 definition of as-built could form part of the basis for a DCD definition of as-built in future design certifications and design certification amendments. Any such DCD definition, however, should also reflect the additional discussion in NEI 08-01 Section 3.1.4. The second paragraph of NEI 08-01 Section

3.1.4 states:

Many ITAAC require verification of as-built SSCs. However, some of these ITAAC will involve measurements and/or testing that can only be conducted at the vendor site due to the configuration of equipment or modules or the nature of the test (e.g., measurements of reactor vessel internals). For these specific items where access to the component for inspection or test is impractical after installation in the plant, the ITAAC closure documentation (e.g., test or inspection record) will be generated at the vendor site and provided to the licensee.

As-built inspections, tests, and analyses of ITAAC SSCs should ordinarily be performed after installation and construction activities at the final location at the plant site. Section 3.1.4 of NEI 08-01 acknowledges that it may be impractical to perform some inspections and testing after installation in the plant. In those cases, it may be appropriate to perform inspections or tests prior to final installation (e.g.,

measuring an interior dimension prior to final assembly of a valve).

Section 3 of NEI 08-01 provides a general description of the role of the ITAAC process in Subpart A, Early Site Permits; Subpart B, Standard Design Certifications; and Subpart C, Combined Licenses, of 10 CFR Part 52. The ITAAC closure process described in NEI 08-01 is consistent with

10 CFR 52.99 requirements for verifying that the construction of a new nuclear plant matches the certified design and the additional criteria listed in the combined license. The discussion on sufficient information further describes the notification letters as required by 10 CFR 52.99(c)(1) and

10 CFR 52.99(c)(2). Section 3 also discusses public hearing opportunities during construction and provides a summary description of the process under 10 CFR 52.103, Operation under a Combined License and its associated fuel load authorization process.

Section 4 of NEI 08-01 provides information on schedule considerations for ITAAC-related activities and coordination to support NRC inspection planning. In accordance with 10 CFR 52.99, the licensee is required to submit an ITAAC closure schedule at 6-month intervals during plant construction.

RG 1.215, Page 5 Within 1 year of fuel load, that interval will decrease to 30 days. The licensees ITAAC closure schedule will allow the NRC staff to plan its oversight activities of onsite and offsite construction inspections. The NRC will consider any licensee claims that the submitted schedule is proprietary and should be withheld from public release under the Freedom of Information Act and 10 CFR 2.390 (Ref. 4).

Section 5 of NEI 08-01 provides guidance on the licensee process for preparation and review of ITAAC closure letters. This section also provides guidance for licensee oversight of ITAAC closure activities and the maintenance of records referenced by the ITAAC closure packages. Section 5 also provides an outline of closure letters. This outline is further detailed in the templates contained in Appendix D to NEI 08-01. Section 5 includes a discussion of a licensees problem identification and resolution (PI&R) program addressing the identification and correction of deficiencies and the prevention of their recurrence as they relate to ITAAC completion.

Section 6 of NEI 08-01 provides guidance on the amount of information that must be contained in ITAAC closure letters. ITAAC closure letters must contain sufficient information to allow the NRC to determine whether the ITAAC have been successfully completed. According to the SOC for the 2007 Part 52 Rule, the closure letters mandated by 10 CFR 52.99(c)(1) must also include sufficient information so that interested persons will have access to information on completed ITAAC at a level of detail sufficient to address the Atomic Energy Act of 1954, Section 189.a(1)(B), threshold for requesting a hearing on whether the acceptance criteria have been, or will be, met. (Ref. 3).

The NRC expects the notification of ITAAC completion to contain more information than just a simple statement that the licensee has completed the ITAAC and has met the acceptance criteria. The NRC expects the notification to be sufficiently complete and detailed for a reasonable person to understand the bases for the licensees representation that it has successfully completed the inspections, tests, and analyses and has met the acceptance criteria. The term sufficient information requires, at a minimum, a summary description of the bases for the licensees conclusion that it has performed the inspections, tests, or analyses and that it has met the prescribed acceptance criteria (Ref. 3).

Each 10 CFR 52.99(c)(1) submittal should include sufficient information on the attributes that validate that the licensee has satisfied the acceptance criteria. The licensee should copy the ITAAC

directly from the certified design and COL to the ITAAC statement. The ITAAC determination basis should include a clearly written, detailed process for how the licensee completed the inspections, tests, or analyses and should explain how the acceptance criteria have been met. Each inspection, test, or analysis should be detailed to clearly indicate how it was completed and should state its results. The results should then be compared to the acceptance criteria and should include the bases for the licensees conclusion that the acceptance criteria have been met. The submittal should also include ITAAC-related construction findings related to the ITAAC and their closure status, confirmation from the licensees official representative that the licensee has met the acceptance criteria, and a list of references applicable to the ITAAC and available for NRC review. Appendix D to NEI 08-01 presents examples of ITAAC closure letters.

Section 7 of NEI 08-01 provides guidance on sufficient information for the 225-day notification of uncompleted ITAAC. The 225-day notification mandated by 10 CFR 52.99(c)(2) must include sufficient information so that interested persons will have access to information on uncompleted ITAAC

at a level of detail sufficient to address the Atomic Energy Act of 1954, Section 189.a(1)(B), threshold for requesting a hearing on whether the acceptance criteria have been, or will be, met (Ref.3). In addition, this requirement will aid the staff in determining if the licensee will be able to satisfy the acceptance

RG 1.215, Page 6 criteria for a given ITAAC. The uncomplete notification will be a predictive summary for how the licensee plans to complete the ITAAC if that ITAAC is not completed by 225 days before scheduled fuel load.

The licensee must demonstrate that it will comply with the ITAAC, and it must provide sufficient information to demonstrate that it will perform the prescribed inspections, tests, or analyses and will meet the prescribed acceptance criteria for the uncompleted ITAAC. The term sufficient information requires, at a minimum, a summary description of the bases for the licensees conclusion that it will perform the inspections, tests, or analyses and that it will meet the prescribed acceptance criteria (Ref. 3).

In addition, sufficient information includes, but is not limited to, a description of the specific procedures and analytical methods that the licensee will use to perform the inspections, tests, and analyses and to determine that it has met the acceptance criteria (Ref. 2).

Each 10 CFR 52.99(c)(2) notification should include sufficient information for both the completed and uncompleted elements of the ITAAC. The licensee should copy the ITAAC directly from the certified design and COL to the ITAAC statement. Items that the licensee has completed toward ITAAC closure should be accompanied by a clearly written, detailed process for how the licensee completed those portions of the inspections, tests, or analyses. Items that remain uncomplete for ITAAC

closure should be accompanied by a clearly written, detailed process for how the licensee expects to complete those portions of the inspections, tests, or analyses and subsequently conclude that the acceptance criteria will be met. Each inspection, test, or analysis for both completed and uncompleted portions should be detailed to clearly indicate how it was, or will be, completed. The submittal should also include a schedule for completing the ITAAC and a list of references applicable to the ITAAC and available for NRC review. Appendix E to NEI 08-01 presents examples of uncomplete notifications.

Section 8 of NEI 08-01 provides a discussion on special topics, including acceptance criteria preservation for closed ITAAC, withdrawals or updates to 10 CFR 52.99 completion notices, design acceptance criteria (DAC) procedures, subsequent COL ITAAC closure, and non-ITAAC systems.

Section 52.103(g) states, The licensee shall not operate the facility until the Commission makes a finding that the acceptance criteria in the combined license are met. Following the completion of any ITAAC,

the licensee must maintain the validity of the acceptance criteria of the closed ITAAC to demonstrate that this requirement is met. One proposed method that the licensee can use to meet this requirement is to include provisions in approved programs such as the quality assurance program, the maintenance program, the problem identification and resolution program, and the design and configuration control program. These provisions should include licensee plans and programs to ensure that the maintenance of items such as structures, systems, or components that are included in ITAAC does not invalidate the conclusion that the acceptance criteria are met.

Withdrawals or updates to a 10 CFR 52.99(e)(1) Federal Register posting are possible if a material error or omission is found to affect the validity of a licensees 10 CFR 52.99(c)(1) notification after it has made the notification.

DAC are a subset and special type of ITAAC. In SECY-92-053 (Ref. 5), Use of Design Acceptance Criteria During 10 CFR Part 52 Design Certification Reviews, DAC were defined by the staff to address design areas that rapidly change or for which sufficient as-built (or, as procured) information is unavailable to support design analysis. For example, digital instrumentation and control (I&C) is a rapidly changing design area and freezing its associated design details early in a design certification stage

RG 1.215, Page 7 could make implementation of the certified design impractical for holders of a combined license, as the final I&C design and installation would be completed years after the design certification was completed.

DAC set forth the processes and acceptance criteria for completing design detail. DAC can be resolved through three different options: (1) an amendment to the design certification (generic), (2) a submittal as part of the combined license application (plant-specific), and (3) closure of the DAC during construction (plant-specific). The NRC staff prefers to resolve DAC through the amendment of the design certification rule or resolve DAC through the COL application review process, because these two scenarios would be completed before construction begins.

As-built ITAAC will be used to demonstrate that the as-built facility conforms to the completed DAC. As-built ITAAC will be resolved as part of the ITAAC closure process. The successful completion of the as-built ITAAC will be documented through the ITAAC completion documentation process described in NEI 08-01.

The DAC review and inspection process is currently being developed. Detailed guidance on NRC review and inspection of DAC will be documented as appropriate when complete. Types of documents being considered include an inspection manual chapter, the standard review plan, or other suitable guidance.

ITAAC closure might involve closure letters that are common to each licensee of a particular design. After the initial closure letter on a common issue is submitted, subsequent licensees could submit letters referencing identical information, but this would not apply to acceptance criteria that require field activities.

Non-ITAAC systems might not have design commitments specifically listed under its system title but, in some cases, have design commitments listed under another system title.

Section 9 of NEI 08-01 provides a list of acronyms used in the guide.

Appendix A to NEI 08-01 provides excerpts from 10 CFR Part 52 that are applicable to the guidelines areas of discussion.

Appendix B to NEI 08-01 is reserved for future use.

Appendix C to NEI 08-01 provides a general description of common ITAAC categories and includes discussions of categories such as calculations and analyses, test procedures, special processes, inspection program, American Society of Mechanical Engineers code design reports, existing reports that conclude that acceptance criteria are met, procurement, material control, and training and qualification.

These discussions are intended to assist the licensee in preparing closure letters or uncomplete notifications for each type of ITAAC category.

Appendix D to NEI 08-01 provides the set of ITAAC closure letters that were prepared during the workshops and public meetings in 2007 and 2008.

Appendix E to NEI 08-01 provides the set of 225-day notifications that were also prepared during the workshops and public meetings in 2007 and 2008. Licensees can use these templates to submit

10 CFR 52.99(c)(1) and 10 CFR 52.99(c)(2) letters. Each template contains a statement of the full

RG 1.215, Page 8 ITAAC as it is included in the COL or certified reactor design, a section describing the bases for considering the ITAAC complete, a section for an ITAAC-related construction finding review, and a closure statement followed by a licensee representative signature for each submittal. Licensees must submit a 10 CFR 52.99(c)(2) notification for each uncompleted ITAAC by the 225-day milestone before scheduled fuel load. The 225-day notification requires additional detail on items completed toward ITAAC closure and on items that must be completed in the time before the 10 CFR 52.103(g) finding.

The staff considers these letters to be examples and anticipates that differing or additional information, consistent with Section 6 of NEI 08-01 (Guidance on Sufficient Information for ITAAC Closure Letters),

may be necessary for individual ITAAC letters. Licensees should review the criteria of Sections 6 and 7 of NEI 08-01 to determine the appropriate content.

3.

Appendices to This Regulatory Guide

Appendix A to this regulatory guide contains the text of 10 CFR 52.99.

Appendix B to this regulatory guide contains the flowchart and description for the implementation of 10 CFR 52.99 and 10 CFR 52.103(g), which the staff developed for use in public workshops, as described in SECY-08-0117. (Ref. 6) The process flowchart blocks include numbered descriptions to further delineate each major milestone in the regulatory process of ITAAC closure and verification up to and including the 10 CFR 52.103(g) finding.

C. REGULATORY POSITION

1.

NEI 08-01

The NRC staff considers the methods discussed in NEI 08-01, Revision 3, to be acceptable for complying with the provisions of 10 CFR 52.99

2.

Other Documents Referenced in NEI 08-01 NEI 08-01 references other documents, but this regulatory guide does not endorse any of the referenced documents.

3.

Use of Examples in NEI 08-01 NEI 08-01 includes examples for ITAAC closure letter submittals and uncomplete notifications for ITAAC. Although these examples are appropriate as general templates for illustrating and reinforcing the guidance in NEI 08-01, the NRCs endorsement of this industry guideline document should not be considered a determination that each example applies to all licensees as it is presented and written in the guide. A licensee should ensure that an example applies to its particular circumstances before implementing the guidance, or template, as described.

4.

Guidance for Site-Specific ITAAC

For licensees who have site-specific ITAAC in their COL, the guidance in NEI 08-01 applies to both design certification and site-specific ITAAC closure notification development.

RG 1.215, Page 9

5.

Use of Other Methods Licensees may use methods other than those provided in NEI 08-01 to meet the requirements of

10 CFR 52.99. The staff will review such methods and determine the acceptability of other methods on a case-by-case basis.

D. IMPLEMENTATION

The purpose of this section is to provide information to applicants and licensees regarding the NRCs plans for using this regulatory guide. The NRC does not intend or approve any imposition or backfit in connection with its issuance.

In some cases, applicants or licensees may propose or use a previously established acceptable alternative method for complying with specified portions of the NRCs regulations. Otherwise, the methods described in this guide will be used in evaluating compliance with the applicable regulations for ITAAC closure.

REGULATORY ANALYSIS / BACKFIT ANALYSIS

The NRC published a regulatory analysis and a backfit analysis with the draft of this guide when it was originally issued for public comment as Draft Regulatory Guide DG-1204, Guidance for ITAAC

Closure Under 10 CFR Part 52. The NRC issued DG-1204 in March 2009 to solicit public comment on the draft of this new Regulatory Guide 1.215, but received no comments on the regulatory analysis or backfit analysis.

RG 1.215, Page 10

REFERENCES1

1.

NEI 08-01, Industry Guideline for the ITAAC Closure Process under 10 CFR Part 52, Revision 3, January 2009, Nuclear Energy Institute, Washington, DC. ADAMS Accession No. ML090270415

2.

10 CFR Part 52.99, Inspection during construction, U.S. Nuclear Regulatory Commission, Washington, DC.

3.

Final Rule for 10 CFR Part 52 Licenses, Certifications, and Approvals for Nuclear Power Plants, August 28, 2007, 72 FR 49352, U.S. Nuclear Regulatory Commission, Washington, DC.

4.

10 CFR Part 2.390, Public inspections, exemptions, requests for withholding, U.S. Nuclear Regulatory Commission, Washington, DC.

5.

SECY-92-053, Use of Design Acceptance Criteria During 10 CFR Part 52 Design Certification Reviews, U.S. Nuclear Regulatory Commission, Washington, DC.

6.

SECY-08-0117, Staff Approach to Verify Closure of Inspections, Tests, Analyses, and Acceptance Criteria and to Implement Title 10 CFR 52.99, Inspection During Construction, and Related Portion of 10 CFR 52.103(g) on the Commission Finding, Enclosure 3, Flowchart and Description of Implementation under 10 CFR 52.99 and 10 CFR 52.103(g),

U.S. Nuclear Regulatory Commission, Washington, DC.

1 Publicly available NRC published documents such as Regulations, Regulatory Guides, NUREGs, and Generic Letters

listed herein are available electronically through the Electronic Reading room on the NRCs public Web site at:

http://www.nrc.gov/reading-rm/doc-collections/. Copies are also available for inspection or copying for a fee from the

NRCs Public Document Room (PDR) at 11555 Rockville Pike, Rockville, MD; the mailing address is USNRC PDR,

Washington, DC 20555; telephone 301-415-4737 or (800) 397-4209; fax (301) 415-3548; and e-mail

PDR.Resource@nrc.gov.

Appendix A to RG 1.215, Page A-1 APPENDIX A

TEXT OF 10 CFR 52.99

§ 52.99 Inspection during construction.

(a) The licensee shall submit to the NRC, no later than 1 year after issuance of the combined license or at the start of construction as defined in 10 CFR 50.10(a), whichever is later, its schedule for completing the inspections, tests, or analyses in the ITAAC. The licensee shall submit updates to the ITAAC schedules every 6 months thereafter and, within 1 year of its scheduled date for initial loading of fuel, the licensee shall submit updates to the ITAAC schedule every 30 days until the final notification is provided to the NRC under paragraph (c)(1) of this section.

(b) With respect to activities subject to an ITAAC, an applicant for a combined license may proceed at its own risk with design and procurement activities, and a licensee may proceed at its own risk with design, procurement, construction, and pre-operational activities, even though the NRC may not have found that any one of the prescribed acceptance criteria have been met.

(c)(1) The licensee shall notify the NRC that the prescribed inspections, tests, and analyses have been performed and that the prescribed acceptance criteria have been met. The notification must contain sufficient information to demonstrate that the prescribed inspections, tests, and analyses have been performed and that the prescribed acceptance criteria have been met.

(2) If the licensee has not provided, by the date 225 days before the scheduled date for initial loading of fuel, the notification required by paragraph (c)(1) of this section for all ITAAC, then the licensee shall notify the NRC that the prescribed inspections, tests, or analyses for all uncompleted ITAAC will be performed and that the prescribed acceptance criteria will be met prior to operation. The notification must be provided no later than the date 225 days before the scheduled date for initial loading of fuel, and must provide sufficient information to demonstrate that the prescribed inspections, tests, or analyses will be performed and the prescribed acceptance criteria for the uncompleted ITAAC will be met, including, but not limited to, a description of the specific procedures and analytical methods to be used for performing the prescribed inspections, tests, and analyses and determining that the prescribed acceptance criteria have been met.

(d)(1) In the event that an activity is subject to an ITAAC derived from a referenced standard design certification and the licensee has not demonstrated that the ITAAC has been met, the licensee may take corrective actions to successfully complete that ITAAC or request an exemption from the standard design certification ITAAC, as applicable. A request for an exemption must also be accompanied by a request for a license amendment under § 52.98(f).

(2) In the event that an activity is subject to an ITAAC not derived from a referenced standard design certification and the licensee has not demonstrated that the ITAAC has been met, the licensee may take corrective actions to successfully complete that ITAAC or request a license amendment under § 52.98(f).

Appendix A to RG 1.215, Page A-2 (e) The NRC shall ensure that the prescribed inspections, tests, and analyses in the ITAAC are performed.

(1) At appropriate intervals until the last date for submission of requests for hearing under § 52.103(a),

the NRC shall publish notices in the Federal Register of the NRC staffs determination of the successful completion of inspections, tests, and analyses.

(2) The NRC shall make publicly available the licensee notifications under paragraph (c)(1), and, no later than the date of publication of the notice of intended operation required by § 52.103(a), make available all licensee notifications under paragraphs (c)(1) and (c)(2) of this section.

[57 FR 60978, Dec. 23, 1992; 72 FR 49536, Aug. 28, 2007; 72 FR 57447, Oct. 9, 2007]

Appendix B to RG 1.215, Page B-1 APPENDIX B

Flowchart and Description of Implementation Under 10 CFR 52.99 and 10 CFR 52.103(g)

No Yes No Yes No No Yes Yes No MC2504 MC2503

52.99(c)(1) submittal

(9)

52.99(c)(2)

Uncomplete ITAAC

notification

(7)

Is the ITAAC

complete?

(1)

Did NRC

determine ITAAC

successfully completed?

(10)

More than

225 days until fuel load? (5)

52.99(c)(1)

submittal

(2)

Yes Tech Specs No ITAAC to be completed by licensee (8)

Fuel load and mode change

(19)

Did NRC

determine ITAAC

successfully completed?

(3)

Licensee needs to complete all ITAAC and submit closure letters for each ITAAC

(17)

10 CFR 52.103(a) Commission must publish notice of intended operation

180 days before scheduled fuel load

10 CFR 52.99(c)(2) Uncomplete ITAAC notification requirement

225 days before scheduled fuel load

52.103(g)

Fuel Load Start construction

(4 to 5 years duration)

For a given ITAAC, ITAAC is considered closed

(11)

FRN of staff determination for individual ITAAC or ITAAC

family, as required

(12)

ITAAC considered to be work-in- progress and closure letter not submitted

(6)

Operation ROP

Yes Substantiated information received that invalidates the closed status of any ITAAC (14)

Update FRN for affected ITAAC as appropriate (15)

ITAAC to be reworked and/or closure letter resubmitted by licensee

(4)

Each ITAAC

listed in the combined license Hearing contentions addressed Timeline of Major Milestones (not to scale)

Licensee use of developed programs to preserve the satisfaction of acceptance criteria of completed ITAAC

(13)

All acceptance criteria are met? (16)

52.103(g)

finding

(18)

Appendix B to RG 1.215, Page B-2 Process block descriptions:

(1)

This is the first decision block for any given inspection, test, analysis, and acceptance criterion (ITAAC), and the licensee needs to assess each ITAAC from the license. Each ITAAC can enter this block at any time during construction regardless of its completed or uncompleted status for processing through this flowchart.

(2)

If (1) is yes, then the licensee must submit a closure letter pursuant to 10 CFR 52.99(c)(1).

(3)

The U.S. Nuclear Regulatory Commission (NRC) will perform ITAAC closure verification activities, including direct inspection, engineering reviews, and consideration of licensee performance within an ITAAC family. Licensee performance within an ITAAC family is taken into consideration for determination of subsequent licensee ITAAC submittals. Yes indicates that the staff has determined that the ITAAC was successfully completed and is closed. No indicates that the ITAAC is not closed and remains uncomplete.

(4)

If (3) is no, the NRC has determined that either the 10 CFR 52.99(c)(1) closure letter information is insufficient or that the licensee has not met the acceptance criteria for the given ITAAC. The licensee will either need to resubmit a closure letter that contains sufficient information demonstrating that it has completed the ITAAC, or the licensee will need to rework the ITAAC and redo the inspections, tests, and analyses. In either case, the licensee will need to resubmit the 10 CFR 52.99(c)(1) closure letter.

(5)

If (1) is no, the licensee needs to identify if the time to scheduled fuel load is greater than 225 days. At the 225-day milestone, the licensee is required to submit 10 CFR 52.99(c)(2)

uncomplete ITAAC notifications for those ITAAC not yet completed and the 10 CFR 52.99(c)(1) closure letter not yet submitted.

(6)

If (5) is yes, there is no 10 CFR 52.99(c)(2) uncomplete notification required for this ITAAC, and the ITAAC under consideration is in the work-in-progress population.

(7)

If (5) is no, the licensee needs to submit to the NRC a 10 CFR 52.99(c)(2) uncomplete ITAAC notification. This notification needs to contain sufficient information to demonstrate that the licensee will perform the ITAAC.

(8)

Entry here indicates that an individual ITAAC remains in the uncomplete population. Once the licensee concludes that it has met the acceptance criteria, process block (9) is entered.

(9)

Upon successfully meeting the acceptance criteria for a given ITAAC, the licensee can submit the 10 CFR 52.99(c)(1) closure letter to the NRC.

(10)

The NRC will perform ITAAC closure verification activities. This decision block is identical to block (3).

(11)

If (10) is yes, the NRC staff has determined that the licensee has met the acceptance criteria.

(12)

The NRC determination that the licensee has successfully completed an ITAAC is published in the Federal Register until the last date for submission of requests for hearings under

10 CFR 52.103(a). The NRC can publish a Federal Register notice (FRN) for individual ITAAC (if needed) or multiple ITAAC (such as an entire family). The NRC is not required to publish an FRN after the last date for submission of requests for hearings under 10 CFR 52.103(a).

(13)

The licensee will apply developed programs such as quality assurance and maintenance to preserve the satisfaction of acceptance criteria for completed ITAAC of applicable structures, systems, and components.

(14)

Any substantiated information received by the NRC, including allegations, can invalidate the closed status of any ITAAC.

(15)

If (14) is yes, then, depending on the severity of the substantiated allegation or information received, the FRN for each affected ITAAC could be updated accordingly. Also depending on the severity of the situation, the licensee may or may not have options available to act accordingly to preserve the FRN for the affected ITAAC.

(16)

This process block collectively considers if the licensee has met all ITAAC acceptance criteria.

(17)

If (16) is no, then the licensee needs to complete all ITAAC and ensure that it meets, and continues to meet, all the acceptance criteria for the 10 CFR 52.103(g) finding.

(18)

At the time of the 10 CFR 52.103(g) finding, all acceptance criteria must be met, such as when (16) is yes. Also, this timeline and flowchart do not contemplate an interim operation scenario whereby the Commission could authorize a period of interim operation that would allow the licensee to load fuel before making the 10 CFR 52.103(g) finding, per 10 CFR

52.103(c).

(19)

With an affirmative Commission 10 CFR 52.103(g) finding, the licensee will be authorized to load fuel and enter operational status.


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