[Federal Register Volume 76, Number 93 (Friday, May 13, 2011)]
[Proposed Rules]
[Pages 27925-27935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-11679]


-----------------------------------------------------------------------

NUCLEAR REGULATORY COMMISSION

10 CFR Parts 2 and 52

 [NRC-2010-0012]
RIN 3150-AI77


Requirements for Maintenance of Inspections, Tests, Analyses, and 
Acceptance Criteria

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or the Commission) 
is proposing to amend its regulations related to verification of 
nuclear power plant construction activities through inspections, tests, 
analyses, and acceptance criteria (ITAAC) under a combined license. 
Specifically, the NRC is proposing new provisions that apply after a 
licensee has completed an ITAAC and submitted an ITAAC closure 
notification. The new provisions would require licensees to report new 
information materially altering the basis for determining that either 
inspections, tests, or analyses were performed as required, or that 
acceptance criteria are met, and to notify the NRC of completion of all 
ITAAC activities. In addition, the NRC is proposing editorial 
corrections to existing language in the NRC's regulations to correct 
and clarify ambiguous language and make it consistent with language in 
the Atomic Energy Act of 1954, as amended (AEA).

DATES: Submit comments on this proposed rule by July 27, 2011. Submit 
comments on the information collection aspects on this proposed rule by 
June 13, 2011. Comments received after the above dates will be 
considered if it is practical to do so, but assurance of consideration 
cannot be given to comments received after these dates.

ADDRESSES: Please include Docket ID NRC-2010-0012 in the subject line 
of your comments. You may submit comments by any one of the following 
methods:
     Federal Rulemaking Web site: Go to http://www.regulations.gov and search for documents filed under Docket ID NRC-
2010-0012. Address questions about NRC dockets to Carol Gallagher, 
telephone: 301-492-3668; e-mail: [email protected].
     Mail comments to: Secretary, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, Attn: Rulemakings and 
Adjudications Staff.
     E-mail comments to: [email protected]. If you do 
not receive a reply e-mail confirming that we have received your 
comments, contact us directly at 301-415-1677.
     Hand deliver comments to: 11555 Rockville Pike, Rockville, 
Maryland 20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. 
(telephone: 301-415-1677).
     Fax comments to: Secretary, U.S. Nuclear Regulatory 
Commission at 301-415-1101.
    You may submit comments on the information collections by the 
methods indicated in the Paperwork Reduction Act Statement, Section XI.
    See Section VI, Availability of Documents, for instructions on how 
to access NRC's Agencywide Documents Access and Management System 
(ADAMS) and other methods for obtaining publicly available documents 
related to this action.

FOR FURTHER INFORMATION CONTACT: Mr. Earl Libby, Office of New 
Reactors, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001; 
telephone: at 301-415-0522; e-mail: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Submitting Comments
II. Background
III. Discussion
    A. Licensee Programs That Maintain ITAAC Conclusions
    B. Additional ITAAC Notifications
    C. Conforming Changes to 10 CFR 2.340
IV. Section-by-Section Analysis
V. Guidance
VI. Availability of Documents
VII. Plain Language
VIII. Agreement State Compatibility
IX. Voluntary Consensus Standards
X. Environmental Impact--Categorical Exclusion
XI. Paperwork Reduction Act Statement
XII. Regulatory Analysis
XIII. Regulatory Flexibility Act Certification
XIV. Backfitting and Issue Finality

I. Submitting Comments

    Comments submitted in writing or in electronic form will be posted 
on the NRC Web site and on the Federal rulemaking Web site http://www.regulations.gov. Because your comments will not be edited to remove 
any identifying or contact information, the NRC cautions you against 
including any information in your submission that you do not want to be 
publicly disclosed.
    The NRC requests that any party soliciting or aggregating comments 
received from other persons for submission to the NRC inform those 
persons that the NRC will not edit their comments to remove any 
identifying or contact information, and therefore, they should not 
include any information in their comments that they do not want 
publicly disclosed.

II. Background

    The Commission first issued Title 10 of the Code of Federal 
Regulations (10 CFR) part 52, ``Licenses, Certifications, and Approvals 
for Nuclear Power Plants,'' on April 18, 1989 (54 FR 15371). Section 
52.99, ``Inspection during construction,'' was included to make it 
clear that the NRC's inspection carried out during construction under a 
combined license would be based on ITAAC proposed by the applicant, 
approved by the NRC staff, and incorporated in the combined license. At 
that time, the Commission made it clear that, although 10 CFR 52.99 
envisioned a ``sign-as-you-go'' process in which the NRC staff would 
sign off on inspection units and notice of the staff's sign-off would 
be published in the Federal Register, the Commission itself would make 
no findings with respect to construction until construction was 
complete. See 54 FR 15371; April 18, 1989; at 15383 (second column).
    On August 28, 2007 (72 FR 49351), the Commission revised 10 CFR 
part 52 to enhance the NRC's regulatory effectiveness and efficiency in 
implementing its licensing and approval processes. In that revision, 
the NRC amended 10 CFR 52.99 to require licensees to notify the NRC 
that the prescribed inspections, tests, and analyses in the ITAAC have 
been completed and that the acceptance criteria have been met. The 
revision also requires that these notifications contain sufficient 
information to demonstrate that the prescribed inspections, tests, and 
analyses have been performed and that the prescribed acceptance 
criteria have been met. The NRC added this requirement to ensure that 
combined license applicants and holders were aware that it was the 
licensee's burden to demonstrate compliance with the ITAAC and the NRC 
expected the notification of ITAAC completion to contain more 
information than just a simple statement that the licensee

[[Page 27926]]

believes the ITAAC had been completed and the acceptance criteria met.
    Under Section 185.b of the AEA and 10 CFR 52.97(b), a combined 
license for a nuclear power plant (a ``facility'') must contain those 
ITAAC that are ``necessary and sufficient to provide reasonable 
assurance that the facility has been constructed and will be operated 
in conformity with'' the license, the AEA, and NRC regulations. 
Following issuance of the combined license, Section 185.b of the AEA 
and 10 CFR 52.99(e) require that the Commission ``ensure that the 
prescribed inspections, tests, and analyses are performed.'' Finally, 
before operation of the facility, Section 185.b of the AEA and 10 CFR 
52.103(g) require that the Commission find that the ``prescribed 
acceptance criteria are met'' (emphasis added). This Commission finding 
will not occur until construction is complete, near the date for 
scheduled initial fuel load.
    As currently required by 10 CFR 52.99(c)(1), the licensee must 
submit ITAAC closure notifications containing ``sufficient information 
to demonstrate that the prescribed inspections, tests, and analyses 
have been performed and that the associated acceptance criteria have 
been met.'' These notifications perform two functions. First, they 
alert the NRC to the licensee's completion of the ITAAC \1\ and ensure 
that the NRC has sufficient information to complete all of the 
activities necessary for the Commission to determine whether all of the 
ITAAC acceptance criteria have been or will be met (the ``will be met'' 
finding is relevant to any hearing on ITAAC under 10 CFR 52.103) before 
initial operation. Second, they ensure that interested persons will 
have access to information on both completed and uncompleted ITAAC at a 
level of detail sufficient to address Section 189.a(1)(B) of the AEA 
threshold for requesting a hearing on acceptance criteria. See 72 FR 
49352; August 28, 2007, at 49450 (second column).
---------------------------------------------------------------------------

    \1\ In this discussion, the phrases ``completion of ITAAC'' and 
``ITAAC completion'' mean that the licensee has determined that: (1) 
The prescribed inspections, tests, and analyses were performed, and 
(2) the prescribed acceptance criteria are met.
---------------------------------------------------------------------------

    After completing the 2007 rulemaking, the NRC began developing 
guidance on the ITAAC closure process and the requirements under 10 CFR 
52.99. In October 2009, the NRC issued regulatory guidance for the 
implementation of the revised 10 CFR 52.99 in Regulatory Guide (RG) 
1.215, ``Guidance for ITAAC Closure Under 10 CFR Part 52.'' This RG 
endorsed guidance developed by the Nuclear Energy Institute (NEI) in 
NEI 08-01, ``Industry Guideline for the ITAAC Closure Process Under 10 
CFR Part 52,'' Revision 3, issued January 2009 (ADAMS Accession No. 
ML090270415).
    After considering information presented by industry representatives 
in a series of public meetings, the NRC realized that some additional 
implementation issues were left unaddressed by the various provisions 
in 10 CFR part 52. In particular, the NRC determined that the combined 
license holder should provide additional notifications to the NRC 
following the notification of ITAAC completion currently required by 10 
CFR 52.99(c)(1). The NRC refers to the time after this ITAAC closure 
notification, but before the date the Commission makes the finding 
under 10 CFR 52.103(g), as the ITAAC maintenance period. Most recently, 
the NRC held two public meetings in March 2010 to discuss draft 
proposed rule text that it made available to the public in February 
2010. The NRC considered feedback given from external stakeholders 
during those meetings in its development of this proposed rule. 
Finally, in March 2010, the NRC issued Inspection Procedure 40600, 
``Licensee Program for ITAAC Management,'' that provides guidance to 
verify licensees have implemented ITAAC maintenance programs to ensure 
that structures, systems, and components continue to meet the ITAAC 
acceptance criteria until the Commission makes the finding under 10 CFR 
52.103(g) allowing operation.

III. Discussion

    In brief, the NRC is proposing the following new notifications 
subsequent to ITAAC closure:
     ITAAC post-closure notification
     All ITAAC complete notification
    In general, the reasons for these proposed new notifications are 
analogous to the reasons presented in the 2007 rulemaking for the 
existing 10 CFR 52.99(c) notifications (i.e., to ensure that the NRC 
has sufficient information, in light of new information developed or 
identified after the ITAAC closure notification under 10 CFR 
52.99(c)(1), to complete all of the activities necessary for the 
Commission to make a determination on ITAAC, and to ensure that 
interested persons have access to information on ITAAC at a level of 
detail sufficient to address the AEA Section 189.a(1)(B) threshold for 
requesting a hearing). After evaluating the various means of ensuring 
that the Commission has sufficient information to make a determination 
on ITAAC, and that interested persons have access to sufficient ITAAC 
information, the NRC is proposing a performance-based rule augmented by 
guidance. The details of timing and content of the proposed new 
notifications are captured in draft guidance being issued for public 
comment simultaneously with this proposed rule, as discussed in more 
detail in Section V, ``Guidance,'' of this document. The NRC believes 
that this approach will allow more flexibility to adjust the guidance 
based on lessons learned during early implementation of the ITAAC 
process under the first combined licenses. Based upon the NRC's 
experience with the overall NRC oversight and verification of ITAAC, 
the notification provisions of the rule, the ITAAC hearing process, and 
the process for making the 10 CFR 52.103(g) finding, the NRC may revise 
and supplement the final guidance on the timing and content of 
notifications.
    The NRC notes that it would not be solely relying on the existence 
of this proposed rulemaking, if approved as a final rule, as a primary 
basis for the 10 CFR 52.103(g) finding. Rather, the NRC would use a 
holistic review using results from the NRC's construction inspection 
program and ITAAC closure review process as primary factors supporting 
a conclusion that the acceptance criteria in the combined license are 
met.
    Each of the proposed notification requirements in this rulemaking, 
and the basis for each of the proposed requirements, are described in 
Section III.B, ``Additional ITAAC Notifications,'' of this document. 
The NRC is also proposing several editorial changes to 10 CFR 52.99 in 
paragraphs (b), (c)(1), proposed (c)(3) (current (c)(2)), and (d)(1). 
In all of these cases, the NRC is proposing to replace the phrase 
``acceptance criteria have been met'' with the phrase ``acceptance 
criteria are met'' for consistency with the wording of the requirement 
in 10 CFR 52.103(g) on the Commission's ITAAC finding, which is derived 
directly from wording in the AEA. In addition, the NRC is proposing an 
editorial change to 10 CFR 52.99(d)(2) to replace the phrase ``ITAAC 
has been met'' with the phrase ``prescribed acceptance criteria are 
met'' for consistency with the wording in 10 CFR 52.99(d)(1).

A. Licensee Programs That Maintain ITAAC Conclusions

    One essential element in ensuring the maintenance of successfully 
completed ITAAC involves the use of established licensee programs such 
as the Quality Assurance Program, Problem Identification and Resolution 
Program, Maintenance/Construction Program, and Design and Configuration 
Management Program. Each program credited with

[[Page 27927]]

supporting the maintenance of completed ITAAC should contain attributes 
that maintain the validity of the ITAAC determination basis. These 
program attributes include the following:
     Licensee screening of activities and events for impact on 
ITAAC;
     Licensee determination of whether supplemental ITAAC 
notification is required; and
     Licensee supplement of the ITAAC closure package as 
appropriate to demonstrate that the acceptance criteria continue to be 
met.
    The NRC expects these programs to be fully implemented and 
effective before the licensee takes credit for them as an appropriate 
means of supporting ITAAC maintenance. These programs will be subject 
to NRC inspection.

B. Additional ITAAC Notifications

    The NRC's confidence in the licensee's ability to maintain the 
validity of completed ITAAC conclusions relies on timely communication. 
Currently, 10 CFR 52.99 specifies two ITAAC notification requirements 
for licensees. These notifications are the ITAAC closure notifications 
required by 10 CFR 52.99(c)(1) and the notification of uncompleted 
ITAAC required by 10 CFR 52.99(c)(2) (proposed 10 CFR 52.99(c)(3)) no 
less than 225 days before scheduled fuel load. The NRC believes that 
additional formal notifications to the NRC are needed that are not 
currently required by regulation.
ITAAC Post-Closure Notification
    The first new notification is contained in proposed 10 CFR 
52.99(c)(2), ``ITAAC post-closure notifications,'' and would be 
required following the licensee's ITAAC closure notifications under 10 
CFR 52.99(c)(1) until the Commission makes the finding under 10 CFR 
52.103(g). This provision would require the licensee to notify the NRC, 
in a timely manner, of new information materially altering the basis 
for determining that either inspections, tests, or analyses were 
performed as required, or that acceptance criteria are met (referred to 
as the ITAAC determination basis).
    The licensee is responsible for maintaining the validity of the 
ITAAC conclusions after completion of the ITAAC. If the ITAAC 
determination basis is materially altered, the licensee is expected to 
notify the NRC. Through public workshops and stakeholder interaction, 
the NRC has developed thresholds to identify when activities would 
materially alter the basis for determining that a prescribed 
inspection, test, or analysis was performed as required, or finding 
that a prescribed acceptance criterion is met. One obvious case is that 
a notification under proposed paragraph (c)(2) would be required to 
correct a material error or omission in the original ITAAC closure 
notification.
    Section 52.6, ``Completeness and accuracy of information,'' 
paragraph (a), requires that information provided to the Commission by 
a licensee be complete and accurate in all material respects. However, 
it might be the case that the original closure notification was 
complete and accurate when sent, but subsequent events materially alter 
the ITAAC determination bases. Also, a material error or omission might 
not be discovered until after the ITAAC closure notification is sent. 
It is possible that new information materially altering the ITAAC 
determination bases would not rise to the reporting threshold under 10 
CFR 52.6(b). As required by 10 CFR 52.6(b), licensees must notify the 
Commission of information identified by the licensee as having, for the 
regulated activity, a significant implication for public health and 
safety or the common defense and security. Given the primary purpose of 
ITAAC, to verify that the plant has been constructed and will be 
operated in compliance with the approved design, the NRC believes that 
it cannot rely on the provisions in 10 CFR 52.6 for licensee reporting 
of new information materially altering the ITAAC determination bases. 
The reasons for this conclusion are as follows:
    1. Material errors and omissions in ITAAC closure notifications, 
relevant to the accuracy and completeness of the documented bases for 
the Commission's finding on ITAAC, may nonetheless be determined in 
isolation by a licensee as not having a significant implication for 
public health and safety or common defense and security.
    2. A Commission finding of compliance with acceptance criteria in 
the ITAAC is required, under Section 185.b of the AEA, in order for the 
combined license holder to commence operation.
    3. The addition of specific reporting requirements addressing 
information relevant and material to the ITAAC finding ensures that the 
NRC will get the necessary reports as a matter of regulatory 
requirement, and allows the NRC to determine the timing and content of 
these reports so that they serve the regulatory needs of the NRC.
    Therefore, the NRC intends that these issues will be reported under 
proposed 10 CFR 52.99(c)(2). In addition to the reporting of material 
errors and omissions, the NRC has identified other circumstances in 
which reporting under this provision would be required (i.e., reporting 
thresholds). These reporting thresholds are described in more detail in 
the Section IV, ``Section-By-Section Analysis,'' of this document.
    When making the 10 CFR 52.103(g) finding, the NRC must have 
information sufficient to determine that the relevant acceptance 
criteria are met despite the new information prompting the notification 
under proposed paragraph (c)(2). The licensee's summary statement of 
the basis for resolving the issue which is the subject of the 
notification, a discussion of any action taken, and a list of the key 
licensee documents supporting the resolution and its implementation, 
would assist the NRC in making its independent evaluation of the issue. 
Apart from the NRC's use of the information, the NRC also believes that 
public availability of such information is necessary to ensure that 
interested persons will have sufficient information to review when 
preparing a request for a hearing under 10 CFR 52.103, comparable to 
the information provided under paragraph (c)(1), as described in the 
Statements of Consideration for the 2007 rulemaking. See August 28, 
2007; 72 FR 49352, at 49384 (second and third column). Accordingly, the 
NRC proposes that after a licensee identifies new information 
materially altering the ITAAC determination basis, it must then submit 
what is essentially a ``resolution'' notification to the NRC in the 
form of an ITAAC post-closure notification. The ITAAC post-closure 
notification, described in proposed paragraph (c)(2), would require the 
licensee to submit a written notification of the resolution of the 
circumstances surrounding the identification of new information 
materially altering the ITAAC determination basis. The ITAAC post-
closure notification must contain sufficient information demonstrating 
that, notwithstanding the information that prompted notification, the 
prescribed inspections, tests, and analyses have been performed as 
required and the prescribed acceptance criteria are met. The ITAAC 
post-closure notifications should explain the need for the 
notification, outline the resolution of the issue, and confirm that the 
ITAAC acceptance criteria continue to be met. The ITAAC post-closure 
notifications must include a level of detail similar to the level of 
information required in initial ITAAC closure notifications under 10 
CFR 52.99(c)(1).
    Proposed 10 CFR 52.99(c)(2) states that licensees must make the 
notification ``in a timely manner.''

[[Page 27928]]

Further discussion of what the NRC considers ``timely'' can be found in 
the NRC guidance being issued simultaneously with this rule, as 
discussed in more detail in Section V of this document.
    The NRC proposes that the notification be available for public 
review under proposed paragraph (e)(2). This would ensure public 
availability and accessibility of all NRC information on ITAAC closure. 
Further explanation of the basis for the availability requirement is 
presented under the discussion on proposed 10 CFR 52.99(e)(2).
    Events that affect completed ITAAC could involve activities that 
include, but are not limited to, maintenance and engineering, program, 
or design changes. The NRC expects that licensees will carry out these 
activities under established programs to maintain ITAAC conclusions and 
that no post-closure notification will be necessary in most instances. 
The NRC can have confidence that prior ITAAC conclusions are maintained 
as long as the ITAAC determination basis established by the original 
ITAAC closure notification is not materially altered. If the ITAAC 
determination basis is not materially altered, licensee activities will 
remain below the notification threshold of proposed 10 CFR 52.99(c)(2). 
If the ITAAC determination basis is materially altered, the licensee 
would be required to notify the NRC under proposed 10 CFR 52.99(c)(2).
    Although the NRC is proposing that licensees be required to notify 
the NRC of information materially altering the ITAAC determination 
basis only after the licensee has evaluated and resolved the issue 
prompting the notification, the NRC encourages licensees to communicate 
with the NRC early in its evaluation process. The purpose of this early 
communication would be to alert the NRC inspection staff to the fact 
that additional activities may be scheduled that affect a structure, 
system, or component (including physical security hardware) or program 
element for which one or more ITAAC have been closed. This will allow 
the NRC inspection staff to discuss the licensee's plans for resolving 
the issue to determine if the staff wants to observe any of the 
upcoming activities for the purpose of making a future staff 
determination about whether the acceptance criteria for those ITAAC 
continue to be met.
All ITAAC Complete Notification
    Another notification that the NRC is proposing is the all ITAAC 
complete notification under 10 CFR 52.99(c)(4). The purpose of this 
notification is to facilitate the required Commission finding under 10 
CFR 52.103(g) that the acceptance criteria in the combined license are 
met. After or concurrent with the last ITAAC closure notification 
required by 10 CFR 52.99(c)(1), the licensee would be required to 
notify the NRC that all ITAAC are complete. When the licensee submits 
the all ITAAC complete notification, the NRC would expect that all 
activities requiring ITAAC post-closure notifications have been 
completed and that the associated ITAAC determination bases have been 
updated.
    To support the Commission's finding under 10 CFR 52.103(g) that the 
acceptance criteria in the combined license are met, if and when 
appropriate, the NRC staff will send a recommendation to the 
Commission. The staff will consider that all ITAAC ``are met'' if both 
of the following conditions hold:
     All ITAAC were verified to be met at one time; and
     The licensee provides confidence that the ITAAC 
determination bases have been maintained and that the ITAAC acceptance 
criteria continue to be met.
    The staff approach would allow licensees to have ITAAC-related 
structures, systems, or components, or security or emergency 
preparedness related hardware, undergoing certain activities at the 
time of the 10 CFR 52.103(g) finding, if the programs credited with 
maintaining the validity of completed ITAAC guide those activities, and 
the activities are not so significant as to exceed a threshold for 
reporting. If a reporting threshold has been exceeded, the NRC would 
need to evaluate the licensee's ITAAC post-closure notification to 
determine whether the ITAAC continue to be met. Reporting thresholds 
are discussed in more detail in the Section-by-Section Analysis section 
of this document.
ITAAC Closure Documentation
    The proposed rule does not contain specific ITAAC documentation and 
record retention requirements. The NRC understands that the nuclear 
power industry believes that holders of combined licenses are already 
required, under regulatory provisions such as 10 CFR part 50, 
``Domestic Licensing of Production and Utilization Facilities,'' 
Appendix B, ``Quality Assurance Criteria for Nuclear Power Plants and 
Fuel Reprocessing Plants,'' to prepare and retain records supporting 
the vast majority of ITAAC processes, including the activities 
supporting the notifications that would be required by the proposed 
rule. Accordingly, the NRC has not included specific documentation and 
record retention requirements in this proposed rule. If the NRC 
inspections disclose substantial issues with licensees' records on 
ITAAC maintenance, the NRC will revisit the need for documentation and 
record retention requirements on ITAAC maintenance.
NRC Inspection, Publication of Notices, and Availability of Licensee 
Notifications
    Section 52.99(e)(1) requires that the NRC publish in the Federal 
Register the NRC staff's determination of the successful completion of 
inspections, tests, and analyses, at appropriate intervals until the 
last date for submission of requests for hearing under 10 CFR 
52.103(a). Section 52.99(e)(2) currently provides that the NRC shall 
make publicly available the licensee notifications under current 
paragraphs (c)(1) and (c)(2). The NRC is proposing to revise paragraph 
(e)(2) to cover all notifications under 10 CFR 52.99(c). In general, 
the NRC expects to make the paragraph (c) notifications available 
shortly after the NRC has received the notifications and concluded that 
they are complete. Furthermore, by the date of the Federal Register 
notice of intended operation and opportunity to request a hearing on 
whether acceptance criteria are met (under 10 CFR 52.103(a)), the NRC 
will make available the licensee notifications under paragraphs (c)(1), 
(c)(2), (c)(3), and (c)(4) that it has received to date.

C. Conforming Changes to 10 CFR 2.340

    The 2007 part 52 rulemaking amended 10 CFR 2.340, ``Initial 
decision in certain contested proceedings; immediate effectiveness of 
initial decisions; issuance of authorizations, permits, and licenses,'' 
to clarify, among other things, the scope of the presiding officer's 
decision in various kinds of NRC proceedings, and remove the 
requirement for direct Commission involvement in all production and 
utilization facility licensing proceedings.
    Section 2.340(j) was intended to address these matters in 
connection with the Commission finding on acceptance criteria and any 
associated hearing under 10 CFR 52.103. In the course of developing 
this proposed rule, the NRC determined that 10 CFR 2.340(j) contains 
several errors and ambiguous statements. The proposed changes, together 
with the proposed bases for the changes, are described below.

[[Page 27929]]

    Section 2.340(j) currently states that the Commission makes a 
finding under 10 CFR 52.103(g) that acceptance criteria ``have been or 
will be met.'' This is incorrect; the Commission's finding under 10 CFR 
52.103(g) is that the acceptance criteria ``are met,'' which is the 
statutory requirement under Section 185.b of the AEA. To correct this 
error, the NRC proposes to amend the introductory language of 10 CFR 
2.340(j) to use the correct phrase, ``acceptance criteria * * * are met 
* * *.''
    In addition, 10 CFR 2.340(j), as currently written, does not 
clearly address the circumstances in a contested proceeding that could 
lead to a Commission finding under 10 CFR 52.103(g) that acceptance 
criteria are met. To provide clarity, the NRC proposes to further amend 
10 CFR 2.340(j) to clearly explain when the Commission may make the 10 
CFR 52.103(g) finding, by further delineating between the presiding 
officer's decisions on contentions that acceptance criteria have not 
been met and decisions on contentions that acceptance criteria will not 
be met. In both cases, if the presiding officer's decision resolves the 
contention favorably this does not obviate the need for the Commission 
to make the required finding under Section 185.b of the AEA and 10 CFR 
52.103(g) that the acceptance criteria are met. For example, the 
presiding officer's initial decision upon summary disposition that a 
particular acceptance criterion has been met may be rendered before the 
occurrence of an event which is ultimately resolved as reported in a 10 
CFR 52.99(c)(2) notification. In such a circumstance, the Commission 
must independently come to the conclusion that the acceptance criterion 
is met. That conclusion must be based upon consideration of both the 
presiding officer's initial decision and information relevant to the 10 
CFR 52.99(c)(2) notification. Accordingly, the NRC concludes that it is 
necessary to clarify the language of paragraph (j). To accommodate the 
proposed clarifications, the Commission proposes to redesignate current 
paragraph (j)(2) as paragraph (j)(4), but without any change to the 
regulatory language.

IV. Section-by-Section Analysis

    The primary changes on ITAAC maintenance being proposed by the NRC 
in this rulemaking are to 10 CFR 52.99. The changes to 10 CFR 2.340 are 
corrections.
Section 2.340 Initial decision in certain contested proceedings; 
immediate effectiveness of initial decisions; issuance of 
authorizations, permits and licenses
Section 2.340(j) Issuance of Finding on Acceptance Criteria Under 10 
CFR 52.103
    Paragraph (j) would be amended to allow the Commission (or the 
appropriate staff Office Director) in a contested proceeding to make 
the finding under 10 CFR 52.103(g) that the acceptance criteria in a 
combined license are met, under certain circumstances that are 
delineated in greater detail in paragraphs (j)(1) through (4). This 
compares with the current rule, which contains only two paragraphs 
(j)(1) and (2). The matters covered by paragraph (j)(1) of the current 
rule would be described with greater clarity in proposed paragraphs 
(j)(1) through (3).
    Proposed paragraph (j)(1) clarifies that the Commission may not 
make the overall 10 CFR 52.103(g) finding unless it is otherwise able 
to find that all uncontested acceptance criteria (i.e., ``acceptance 
criteria not within the scope of the initial decision of the presiding 
officer'') are met. The phrase ``otherwise able to make'' conveys the 
NRC's determination that the Commission's process for supporting a 
Commission finding on uncontested acceptance criteria is unrelated to 
and unaffected by the timing of the presiding officer's initial 
decision.
    Proposed paragraph (j)(2) clarifies that a presiding officer's 
initial decision which finds that acceptance criteria have been met, is 
a necessary but not sufficient prerequisite for the Commission to make 
a finding that the contested acceptance criteria (i.e., the criteria 
which are the subject of the presiding officer's initial decision) are 
met. The Commission must thereafter, even if the presiding officer's 
initial decision finds that the contested acceptance criteria have been 
met, be able to make a finding that the contested criteria are met 
after considering: (1) Information submitted in the licensee 
notifications which the NRC proposes to be included in 10 CFR 52.99; 
and (2) the NRC staff's findings with respect to these notifications, 
to issue the overall 10 CFR 52.103 finding. By using the word 
``thereafter,'' the NRC intends to emphasize that the Commission would 
not make a finding that contested acceptance criteria are met in 
advance of the presiding officer's initial decision on those acceptance 
criteria.
    Proposed paragraph (j)(3) expresses the same concept as paragraph 
(j)(2) but as applied to findings that acceptance criteria will be met. 
Thus, even if a presiding officer's initial decision finds that the 
contested acceptance criteria will be met, the Commission must 
thereafter be able to make a finding that the contested criteria are 
met after considering: (1) Information submitted in an ITAAC closure 
notification pursuant to 10 CFR 52.99(c)(1); (2) information submitted 
in the licensee notifications which the NRC proposes to be included in 
10 CFR 52.99; and (3) the NRC staff's findings with respect to such 
notifications, to issue the overall 10 CFR 52.103 finding.
    Proposed paragraph (j)(4) is the same as the existing provision in 
10 CFR 2.340(j)(2). This paragraph provides that the Commission may 
make the 52.103(g) finding notwithstanding the pendency of a petition 
for reconsideration under 10 CFR 2.345, a petition for review under 10 
CFR 2.341, a motion for a stay under 10 CFR 2.342, or a petition under 
10 CFR 2.206.
    The NRC notes that 10 CFR 2.340(j) is not intended to be an 
exhaustive ``roadmap'' to a possible 10 CFR 52.103(g) finding that 
acceptance criteria are met. For example, this provision does not 
directly address what must occur for the Commission to make a 10 CFR 
52.103(g) finding where the presiding officer finds, with respect to a 
contention, that acceptance criteria are not met. The NRC also notes 
that this provision applies only to contested proceedings. If there is 
no hearing under 10 CFR 52.103, or if the hearing ends without a 
presiding officer's initial decision on the merits (e.g., a withdrawal 
of the sole party in a proceeding), then 10 CFR 2.340(j) does not 
govern the process by which the Commission (or the appropriate staff 
Office Director) makes the 10 CFR 52.103(g) finding.
Section 52.99 Inspection During Construction; ITAAC Schedules and 
Notifications; NRC Notices
    Although the NRC is not making changes to every paragraph under 10 
CFR 52.99, for simplicity, this rulemaking would replace the section in 
its entirety. Therefore, the NRC is providing a section-by-section 
discussion for every paragraph in 10 CFR 52.99. For those paragraphs 
where little or no change is being proposed, the NRC is repeating the 
section-by-section discussion from the 2007 major revision to 10 CFR 
part 52 with editorial and conforming changes, as appropriate.
    The purpose of this section is to present the requirements to 
support the NRC's inspections during construction, including 
requirements for ITAAC

[[Page 27930]]

schedules and notifications and for NRC notices of ITAAC closure.
Section 52.99(a) Licensee Schedule for Completing Inspections, Tests, 
or Analyses
    The NRC is not proposing any changes to this paragraph. Paragraph 
(a) requires that the licensee submit to the NRC, no later than 1 year 
after issuance of the combined license or at the start of construction 
as defined at 10 CFR 50.10, whichever is later, its schedule for 
completing the inspections, tests, or analyses in the ITAAC. This 
provision also requires the licensee to submit updates to the ITAAC 
schedule every 6 months thereafter and, within 1 year of its scheduled 
date for initial loading of fuel, licensees must submit updates to the 
ITAAC schedule every 30 days until the final notification is provided 
to the NRC under 10 CFR 52.99(c). The information provided by the 
licensee will be used by the NRC in developing the NRC's inspection 
activities and activities necessary to support the Commission's finding 
whether all of the ITAAC are met prior to the licensee's scheduled date 
for fuel load. Even in the case where there were no changes to a 
licensee's ITAAC schedule during an update cycle, the NRC expects the 
licensee to notify the NRC that there have been no changes to the 
schedule.
Section 52.99(b) Licensee and Applicant Conduct of Activities Subject 
to ITAAC
    The NRC is proposing an editorial change to the last sentence of 10 
CFR 52.99(b) to replace the words ``have been met'' with ``are met'' 
for consistency with the requirements of Section 185.b of the AEA, as 
implemented in 10 CFR 52.103(g). The purpose of the requirement in 10 
CFR 52.99(b) is to clarify that an applicant may proceed at its own 
risk with design and procurement activities subject to ITAAC, and that 
a licensee may proceed at its own risk with design, procurement, 
construction, and preoperational testing activities subject to an 
ITAAC, even though the NRC may not have found that any particular ITAAC 
are met.
Section 52.99(c) Licensee Notifications
Section 52.99(c)(1) ITAAC Closure Notification and Section 52.99(c)(3) 
Uncompleted ITAAC Notification
    The NRC is proposing editorial changes in 10 CFR 52.99(c)(1) to 
replace the words ``have been met'' with ``are met.'' Section 
52.99(c)(1) would require the licensee to notify the NRC that the 
prescribed inspections, tests, and analyses have been performed and 
that the prescribed acceptance criteria are met. Section 52.99(c)(1) 
would further require that the notification contain sufficient 
information to demonstrate that the prescribed inspections, tests, and 
analyses have been performed and that the prescribed acceptance 
criteria are met.
    The NRC is proposing to renumber current 10 CFR 52.99(c)(2) as 
proposed 10 CFR 52.99(c)(3). In addition, the NRC is proposing an 
editorial change to the last sentence in proposed 10 CFR 52.99(c)(3) 
(current 10 CFR 52.99(c)(2)) to replace the words ``have been met'' 
with ``are met.'' Proposed paragraph 52.99(c)(3) would require that, 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 
(consistent with the AEA Section 185.b requirement that the Commission, 
``prior to operation,'' find that the acceptance criteria in the 
combined license are met). 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.
    Section 52.99(c) ensures that: (1) The NRC has sufficient 
information to complete all of the activities necessary for the 
Commission to make a finding as to whether all of the ITAAC are met 
prior to initial operation; and (2) interested persons will have access 
to information on both completed and uncompleted ITAAC at a level of 
detail sufficient to address the AEA Section 189.a(1)(B) threshold for 
requesting a hearing on acceptance criteria. It is the licensee's 
burden to demonstrate compliance with the ITAAC, and the NRC expects 
the information submitted under paragraph (c)(1) to contain more than 
just a simple statement that the licensee believes the ITAAC have been 
completed and the acceptance criteria met. The NRC would expect the 
notification to be sufficiently complete and detailed for a reasonable 
person to understand the bases for the licensee's representation that 
the inspections, tests, and analyses have been successfully completed 
and the acceptance criteria are met. The term ``sufficient 
information'' would require, at a minimum, a summary description of the 
bases for the licensee's conclusion that the inspections, tests, or 
analyses have been performed and that the prescribed acceptance 
criteria are met.
    Furthermore, with respect to uncompleted ITAAC, it is the 
licensee's burden to demonstrate that it will comply with the ITAAC and 
the NRC would expect the information that the licensee submits under 
proposed paragraph (c)(3) to be sufficiently detailed such that the NRC 
staff can determine what activities it will need to undertake to 
determine if the acceptance criteria for each of the uncompleted ITAAC 
are met, once the licensee notifies the NRC that those ITAAC have been 
successfully completed and their acceptance criteria met. The term 
``sufficient information'' requires, at a minimum, a summary 
description of the bases for the licensee's conclusion that the 
inspections, tests, or analyses will be performed and that the 
prescribed acceptance criteria will be met. In addition, ``sufficient 
information'' includes, but is not limited to, a description of the 
specific procedures and analytical methods to be used for performing 
the inspections, tests, and analyses and determining that the 
acceptance criteria are met.
    The NRC notes that, even though it did not include a provision 
requiring the completion of all ITAAC by a certain time prior to the 
licensee's scheduled fuel load date, the NRC staff will require some 
period of time to perform its review of the last ITAAC once the 
licensee submits its notification that the ITAAC has been successfully 
completed and the acceptance criteria met. In addition, the Commission 
itself will require some period of time to perform its review of the 
staff's conclusions regarding all of the ITAAC and the staff's 
recommendations regarding the Commission finding under 10 CFR 
52.103(g).
Section 52.99(c)(2) ITAAC Post-Closure Notifications
    The NRC is proposing to add new paragraph (c)(2) that would require 
the licensee to notify the NRC, in a timely manner, of new information 
that materially alters the bases for determining that either 
inspections, tests, or analyses were performed as required, or that 
acceptance criteria are met. The notification must 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.
    Fundamentally, those circumstances requiring notification under 
proposed

[[Page 27931]]

paragraph (c)(2) fall into the following two categories:
     The information presented or referenced in the original 10 
CFR 52.99(c)(1) notification is insufficient, either because it omits 
material information, or because the information is materially 
erroneous or incorrect, and the licensee discovers or determines there 
is a material omission or error after filing the original 10 CFR 
52.99(c)(1) notification.
     The information presented or referenced in the original 10 
CFR 52.99(c)(1) notification was complete (i.e., not omitting material 
information) and accurate (i.e., not materially erroneous), but there 
is new material information with respect to the subject of the original 
10 CFR 52.99(c)(1) notification.
    The term ``materially altering'' refers to situations in which 
there is information not contained in the 10 CFR 52.99(c)(1) 
notification that ``has a natural tendency or capability to influence 
an agency decision maker'' in either determining whether the prescribed 
inspection, test, or analysis was performed as required, or finding 
that the prescribed acceptance criterion is met. See Final Rule; 
Completeness and Accuracy of Information, December 31, 1987; 52 FR 
49362, at 49363. Applying this concept in the context of 10 CFR 
52.99(c), information for which notification would be required under 
paragraph (c)(2) is that information which, considered by itself or 
when considered in connection with information previously submitted or 
referenced by the licensee in a paragraph (c)(1) notification, relates 
to information which is necessary for any of the following:
     The licensee to assert that the prescribed inspections, 
tests, and analyses have been performed and the acceptance criteria are 
met;
     The NRC staff to determine if (and provide a 
recommendation to the Commission as to whether) the prescribed 
inspections, tests, and analyses were performed and the acceptance 
criteria are met; or
     The Commission to find that the acceptance criteria are 
met, as required by Section 185.b of the AEA and 10 CFR 52.103(g).
    The term ``new'' information embraces three different kinds of 
information:
     New information (i.e., a ``discovery'' or new 
determination identified after the 10 CFR 52.99(c)(1) notification) 
about the accuracy of material information provided in, referenced by, 
or necessary to support representations made in that notification.
     New information (i.e., a ``discovery'' or new 
determination identified after the 10 CFR 52.99(c)(1) notification) 
that previously existing information should have been, but was not 
provided in the notification or referenced in the supporting 
documentation (i.e., an omission of material information).
     Information on a ``new'' event or circumstance (i.e., an 
event or circumstance occurring after the 10 CFR 52.99(c)(1) 
notification) that materially affects the accuracy or completeness of 
the basis, as reported or relied upon in the 52.99(c)(1) notification, 
for the licensee's representation that the acceptance criteria are met.
    Applying these concepts, the NRC believes that the circumstances 
for which reporting under this provision would be required include:
     Material Error or Omission--Is there a material error or 
omission in the original ITAAC closure notification?
     Post Work Verification (PWV)--Will the PWV performed 
following work undertaken to resolve an issue reportable under 10 CFR 
52.99(c)(2) use a significantly different approach than the original 
performance of the inspection, test, or analysis as described in the 
original ITAAC notification?
     Engineering Changes--Will an engineering change be made 
that materially alters the determination that the acceptance criteria 
are met?
     Additional Items To Be Verified--Will there be additional 
items that need to be verified through the ITAAC?
     Complete and Valid ITAAC Representation--Will any other 
licensee activities materially alter the ITAAC determination basis?
    Additional guidance on implementing these reporting thresholds is 
being proposed in a draft revision to RG 1.215, being issued for public 
comment simultaneously with this proposed rule. This proposed guidance 
is discussed further in Section V, ``Guidance,'' of this document.
    Proposed paragraph (c)(2) would require the licensee to submit an 
ITAAC post-closure notification documenting the resolution of the 
circumstances surrounding the identification of new material 
information. By ``resolution,'' the NRC means: (1) The completion of 
the licensee's technical evaluation of the issue and the determination 
as to whether the prescribed inspection, test, or analysis was 
performed as required; (2) licensee completion of any necessary 
corrective or supplemental actions; (3) licensee documentation of the 
issue and any necessary corrective or supplemental actions in order to 
bring the ITAAC determination basis up to date; and (4) ultimate 
licensee determination about whether the affected acceptance criteria 
continue to be met.
    The information provided in the notification should be at a level 
of detail comparable to the ITAAC closure notification under paragraph 
(c)(1). The dual purposes of the proposed paragraph (c)(2) 
notification, as described in Section III.B, ``Additional ITAAC 
Notifications,'' of this document, are comparable to the purposes of 
the ITAAC closure notification in paragraph (c)(1). Thus, the NRC 
believes that the considerations for the content of the ITAAC closure 
notification, as discussed in the final 2007 rulemaking, apply to the 
proposed paragraph (c)(2) notifications. See 72 FR 49450; August 28, 
2007 (second column). Thus, it is the licensee's burden to demonstrate 
compliance with the ITAAC, taking into account any new information that 
materially alters the determination that a prescribed inspection, test, 
or analysis was performed as required or that a prescribed acceptance 
criterion is met. The NRC expects the paragraph (c)(2) notification to 
contain more than just a simple statement that the licensee has 
concluded, despite the material new information, that the prescribed 
inspection, test, or analysis was performed as required and that a 
prescribed acceptance criterion is met. The NRC expects the 
notification to be sufficiently complete and detailed for a reasonable 
person to understand the bases for the licensee's determination in the 
paragraph (c)(2) notification. The term ``sufficient information'' is 
comparable to the meaning given to that term in paragraph (c)(1), and 
requires, at a minimum, a summary description of the bases for the 
licensee's determination. In addition, ``sufficient information'' 
includes, but is not limited to, a description of the specific 
procedures and analytical methods used or relied upon to develop or 
support the licensee's determination. The paragraph (c)(2) notification 
must be in writing, and the records on which it is based must be 
retained by the licensee to support possible NRC inspection. Licensees 
should use the same process for submitting ITAAC post-closure 
notifications as would be used to submit initial ITAAC closure 
notifications. The NRC is issuing draft guidance on implementation of 
the requirements in proposed paragraph (c)(2), including the level of 
detail necessary to comply with the requirements of proposed paragraph 
(c)(2), as discussed in Section V of this document.

[[Page 27932]]

Section 52.99(c)(4) All ITAAC Complete Notification
    Section 52.99(c)(4) would require the licensee to notify the NRC 
that all ITAAC are complete (All ITAAC Complete Notification). When the 
licensee submits the all ITAAC complete notification, the NRC would 
expect that all activities requiring ITAAC post-closure letters have 
been completed, that the associated ITAAC determination bases have been 
updated, and that all required notifications under proposed paragraph 
(c)(2) have been made.
Section 52.99(d) Licensee Determination of Non-Compliance With ITAAC
    Paragraph (d) states the options that a licensee will have in the 
event that it is determined that any of the acceptance criteria in the 
ITAAC are not met. If an activity is subject to an ITAAC derived from a 
referenced standard design certification and the licensee has not 
demonstrated that the ITAAC are 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 an application for a 
license amendment under 10 CFR 52.98(f). The NRC will consider and take 
action on the request for exemption and the license amendment 
application together as an integrated NRC action.
    Also, if an activity that 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 10 CFR 52.98(f).
Section 52.99(e) NRC Inspection, Publication of Notices, and 
Availability of Licensee Notifications
    Paragraph (e)(1) of this section indicates that the NRC is 
responsible for ensuring (through its inspection and audit activities) 
that the combined license holder performs and documents the completion 
of inspections, tests, and analyses in the ITAAC. Paragraph (e)(1) 
requires the NRC to publish, at appropriate intervals until the last 
date for submission of requests for hearing under 10 CFR 52.103(a), 
notices in the Federal Register of the NRC staff's determination of the 
successful completion of inspections, tests, and analyses. Paragraph 
(e)(2) provides that the NRC shall make publicly available the licensee 
notifications under paragraph (c). In general, the NRC expects to make 
the paragraph (c) notifications available shortly after the NRC has 
received the notifications and concluded that they are complete and 
detailed. Further, by the date of the Federal Register notice of 
intended operation and opportunity to request a hearing on whether 
acceptance criteria are met (under 10 CFR 52.103(a)), the NRC will make 
available the licensee notifications under paragraphs (c)(1), (c)(2), 
(c)(3), and (c)(4) received to date.

V. Guidance

    In conjunction with the issuance of this proposed rule, the NRC is 
issuing a proposed revision to its regulatory guidance in RG 1.215 on 
implementation of the requirements in 10 CFR 52.99. In this proposed 
revision, the NRC is endorsing Revision 4 to the existing industry 
ITAAC closure guidance in NEI 08-01, submitted to the NRC for 
endorsement on July 16, 2010 (ADAMS Accession No. ML102010076). The 
revised guidance is intended to provide an acceptable method by which 
licensees can implement the new requirements being proposed in this 
rulemaking. The staff will consider any comments received on the 
proposed rule in its final revisions to RG 1.215. The NRC expects that 
all guidance necessary to implement this rule will be available at the 
time that the final rule becomes effective.

VI. Availability of Documents

    You can access publicly available documents related to this 
proposed rule using the following methods:
     NRC's Public Document Room (PDR): The public may examine 
and have copied for a fee publicly available documents at the NRC's 
PDR, Room O1 F21, One White Flint North, 11555 Rockville Pike, 
Rockville, Maryland 20852.
     NRC's Agencywide Documents Access and Management System 
(ADAMS): Publicly available documents created or received at the NRC 
are available electronically at the NRC's Electronic Reading Room at 
http://www.nrc.gov/reading-rm/adams.html. From this page, the public 
can gain entry into ADAMS, which provides text and image files of NRC's 
public documents. If you do not have access to ADAMS or if there are 
problems in accessing the documents located in ADAMS, contact the NRC's 
PDR reference staff at 1-800-397-4209, 301-415-4737, or by e-mail to 
[email protected].
     Federal Rulemaking Web site: Public comments and 
supporting materials related to this proposed rule can be found at 
http://www.regulations.gov by searching on Docket ID: NRC-2010-0012.
    The NRC is making the documents identified below available to 
interested persons through one or more of the following methods as 
indicated:

----------------------------------------------------------------------------------------------------------------
                  Document                        PDR           Web                       ADAMS
----------------------------------------------------------------------------------------------------------------
SECY-09-0119, ``Staff Progress in Resolving            X             X   ML091980372
 Issues Associated with Inspections, Tests,
 Analyses and Acceptance Criteria'' (August
 26, 2009).
SRM-M090922--Staff Requirements--Periodic              X             X   ML092890658
 Briefing on New Reactor Issues--Progress
 in Resolving Issues Associated with
 Inspections, Tests, Analyses, and
 Acceptance Criteria (ITAAC), 9:30 A.M.,
 Tuesday, September 22, 2009 (October 16,
 2009).
Inspection Procedure 40600, ``Licensee                 X             X   ML072530607
 Program for ITAAC Management''.
Regulatory Guide 1.215, ``Guidance for                 X             X   ML091480076
 ITAAC Closure Under 10 CFR Part 52,''
 Revision 0 (October 31, 2009).
NEI 08-01, ``Industry Guideline for the                X   ............  ML090270415
 ITAAC Closure Process Under 10 CFR Part
 52,'' Revision 3 (January 2009).
NEI 08-01, ``Industry Guideline for the                X   ............  ML102010076
 ITAAC Closure Process Under 10 CFR Part
 52,'' Revision 4.
Regulatory Analysis for Proposed Rule--                X             X   ML110040395
 Requirements for Maintenance of
 Inspections, Tests, Analyses, and
 Acceptance Criteria (February 2011).
NUREG/BR-0058, ``Regulatory Analysis                   X             X   ML042820192
 Guidelines of the U.S. Nuclear Regulatory
 Commission,'' Revision 4 (September 2004).
----------------------------------------------------------------------------------------------------------------


[[Page 27933]]

VII. Plain Language

    The Presidential memorandum, ``Plain Language in Government 
Writing'' published June 10, 1998 (63 FR 31883), directed that the 
Government's documents be in clear and accessible language. The NRC 
requests comments on the proposed rule specifically with respect to the 
clarity and effectiveness of the language used. Comments should be sent 
to the NRC as explained in the ADDRESSES caption of this document.

VIII. Agreement State Compatibility

    Under the ``Policy Statement on Adequacy and Compatibility of 
Agreement States Programs,'' approved by the Commission on June 20, 
1997, and published in the Federal Register (62 FR 46517; September 3, 
1997), this rule is classified as compatibility ``NRC.'' Compatibility 
is not required for Category ``NRC'' regulations. The NRC program 
elements in this category are those that relate directly to areas of 
regulation reserved to the NRC by the AEA or the provisions of 10 CFR. 
Although an Agreement State may not adopt program elements reserved to 
the NRC, it may wish to inform its licensees of certain requirements 
via a mechanism that is consistent with the particular State's 
administrative procedure laws. Category ``NRC'' regulations do not 
confer regulatory authority on the State.

IX. Voluntary Consensus Standard

    The National Technology Transfer and Advancement Act of 1995, Pub. 
L. 104-113, requires that Federal agencies use technical standards that 
are developed or adopted by voluntary consensus standards bodies unless 
using such a standard is inconsistent with applicable law or is 
otherwise impractical. The requirements in this rulemaking address 
procedural and information collection and reporting requirements 
necessary to support the NRC's regulatory activities on combined 
licenses under 10 CFR part 52, and to facilitate the NRC's conduct of 
hearings on ITAAC which may be held under Section 189 of the AEA. These 
requirements do not establish standards or substantive requirements 
with which combined license holders must comply. Thus, this rulemaking 
does not constitute establishment of a standard containing generally 
applicable requirements falling within the purview of the National 
Technology Transfer and Advancement Act and the implementing guidance 
issued by the Office of Management and Budget (OMB).

X. Environmental Impact--Categorical Exclusion

    The NRC has determined that these amendments fall within the types 
of actions described as categorical exclusions under 10 CFR 51.22(c)(2) 
and (c)(3). Therefore, neither an environmental impact statement nor an 
environmental assessment has been prepared for this regulation.

XI. Paperwork Reduction Act Statement

    This proposed rule contains new or amended information collection 
requirements that are subject to the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq). This rule has been submitted to the OMB for 
review and approval of the information collection requirements.
    1. Type of submission, new or revision: Revision.
    2. The title of the information collection: 10 CFR Parts 2 and 52; 
Requirements for Maintenance of Inspections, Tests, Analyses, and 
Acceptance Criteria.
    3. Form number, if applicable: N/A.
    4. How often the collection is required: On occasion. Reports 
required under 10 CFR 52.99(c)(2) and (c)(4) are collected and 
evaluated during construction, (1) whenever a licensee determines that 
it has new information materially altering the basis for an ITAAC 
determination; and (2) once, when all ITAAC are complete.
    5. Who is required or asked to report: Combined license holders, 
during the period of construction.
    6. An estimate of the number of annual responses: 48 (44 annual 
responses plus 3.66 annualized one-time responses).
    7. The estimated number of annual respondents: 7.33.
    8. The number of hours needed annually to complete the requirement 
or request: 1,056 hours.
    9. Abstract: The NRC is proposing to amend its regulations in 10 
CFR 52.99 related to verification of nuclear power plant construction 
activities through ITAAC under a combined license. Specifically, the 
NRC is proposing new provisions that apply after a licensee has 
completed an ITAAC and submitted an ITAAC closure notification. The new 
provisions would require licensees to (1) report new information 
materially altering the basis for determining that either inspections, 
tests, or analyses were performed as required, or that acceptance 
criteria are met; and (2) notify the NRC of completion of all ITAAC 
activities.
    The NRC is seeking public comment on the potential impact of the 
information collections contained in this proposed rule and on the 
following issues:
    1. Is the proposed collection of information necessary for the NRC 
to properly perform its functions? Does the information have practical 
utility?
    2. Is the burden estimate accurate?
    3. Is there a way to enhance the quality, utility, and clarity of 
the information to be collected?
    4. How can the burden of the information collection be minimized, 
including the use of automated collection techniques or other forms of 
information technology?
    A copy of the OMB clearance package may be viewed free of charge at 
the NRC Public Document Room, One White Flint North, 11555 Rockville 
Pike, Room O-1 F21, Rockville, Maryland 20852. The OMB clearance 
package and rule are available at the NRC Web site, http://www.nrc.gov/public-involve/doc-comment/omb/index.html, for 60 days after the 
signature date of this document.
    Send comments on any aspect of these proposed regulations related 
to information collections, including suggestions for reducing the 
burden and on the above issues, by June 13, 2011 to the Information 
Services Branch (T-5 F52), U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, or by Internet electronic mail to 
[email protected] and to the Desk Officer, Christine Kymn, 
Office of Information and Regulatory Affairs, NEOB-10202 (3150-0151), 
Office of Management and Budget, Washington, DC 20503. Comments on the 
proposed information collections may also be submitted via the Federal 
rulemaking Web site, https://www.regulations.gov, Docket ID NRC-2010-
0012. Comments received after this date will be considered if it is 
practical to do so, but assurance of consideration cannot be given to 
comments received after this date.
Public Protection Notification
    The NRC may not conduct or sponsor, and a person is not required to 
respond to, a request for information or an information collection 
requirement unless the requesting document displays a currently valid 
OMB control number.

XII. Regulatory Analysis

    The Commission has prepared a draft regulatory analysis on this 
proposed regulation. The analysis examines the costs and benefits of 
the alternatives considered by the Commission.
    The Commission requests public comment on the draft regulatory

[[Page 27934]]

analysis. Comments on the draft analysis may be submitted to the NRC as 
indicated under the ADDRESSES section of this document. The analysis is 
available for inspection in the NRC's PDR (ADAMS Accession No. 
ML110040395), 11555 Rockville Pike, Rockville, Maryland 20852. The 
analysis may also be viewed and downloaded electronically via the 
Federal rulemaking Web site at http://www.regulations.gov by searching 
for Docket ID NRC-2010-0012.

XIII. Regulatory Flexibility Act Certification

    In accordance with the Regulatory Flexibility Act (5 U.S.C. 
605(b)), the Commission certifies that this rule will not, if 
promulgated, have a significant economic impact on a substantial number 
of small entities. This proposed rule affects only the licensing and 
operation of nuclear power plants. The companies that own these plants 
do not fall within the scope of the definition of ``small entities'' 
set forth in the Regulatory Flexibility Act or the size standards 
established by the NRC (10 CFR 2.810).

XIV. Backfitting and Issue Finality

    The NRC has determined that neither the backfit rule, 10 CFR 
50.109, nor any of the finality provisions in 10 CFR part 52, apply to 
this proposed rule. Therefore, a backfit analysis is not required 
because the proposed ITAAC maintenance rule does not contain any 
provisions that would impose backfitting as defined in the backfit 
rule, nor does it contain provisions that are inconsistent with the 
finality provisions applicable to applicants for or holders of combined 
licenses in 10 CFR part 52.
    The proposed rule would apply only to holders of combined licenses. 
The backfitting provisions in 10 CFR 50.109 protect holders of combined 
licenses, and the finality provisions in Subpart C of part 52 protect 
holders of combined licenses (with the exception discussed further in 
this document). There are no current holders of combined licenses; 
hence, those backfitting and finality provisions do not apply to this 
rulemaking. Subpart C of part 52 contains issue finality provisions 
which protect combined license applicants, but that protection extends 
only to issue resolution of matters resolved in referenced early site 
permits, standard design certifications, standard design approvals, or 
manufactured reactors. This proposed rule does not alter issue 
resolution associated with referenced early site permits, standard 
design certifications, standard design approvals, or manufactured 
reactors. Instead, this proposed rule addresses requirements concerning 
the Commission's finding that ITAAC are met, and the conduct of 
hearings addressing whether prescribed inspections, tests, and analyses 
have been performed and the acceptance criteria are met. To the extent 
that the proposed rule would revise these requirements for future 
combined licenses, the requirements would not constitute backfitting or 
otherwise be inconsistent with the finality provisions in 10 CFR part 
52, because the requirements are prospective in nature and effect. 
Neither the backfit rule nor the issue finality provisions in 10 CFR 
part 52 were intended to apply to every NRC action, which substantially 
changes the obligations of future licensees under 10 CFR part 52. 
Accordingly, the NRC has not prepared a backfit analysis or other 
evaluation for this proposed rule.

List of Subjects

10 CFR Part 2

    Administrative practice and procedure, Antitrust, Byproduct 
material, Classified information, Environmental protection, Nuclear 
materials, Nuclear power plants and reactors, Penalties, Sex 
discrimination, Source material, Special nuclear material, Waste 
treatment and disposal.

10 CFR Part 52

    Administrative practice and procedure, Antitrust, Backfitting, 
Combined license, Early site permit, Emergency planning, Fees, 
Inspection, Limited work authorization, Nuclear power plants and 
reactors, Probabilistic risk assessment, Prototype, Reactor siting 
criteria, Redress of site, Reporting and recordkeeping requirements, 
Standard design, Standard design certification.
    For the reasons set out in the preamble and under the authority of 
the Atomic Energy Act of 1954, as amended; the Energy Reorganization 
Act of 1974, as amended; and 5 U.S.C. 553, the NRC is proposing to 
adopt the following amendments to 10 CFR parts 2 and 52.

PART 2--RULES OF PRACTICE FOR DOMESTIC LICENSING PROCEEDINGS AND 
ISSUANCE OF ORDERS

    1. The authority citation for part 2 continues to read as follows:

    Authority: Secs. 161, 181, 68 Stat. 948, 953, as amended (42 
U.S.C. 2201, 2231); sec. 191, as amended, Pub. L. 87-615, 76 Stat. 
409 (42 U.S.C. 2241); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 
5841); 5 U.S.C. 552; sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 
note).

    Section 2.101 also issued under secs. 53, 62, 63, 81, 103, 104, 
68 Stat. 930, 932, 933, 935, 936, 937, 938, as amended (42 U.S.C. 
2073, 2092, 2093, 2111, 2133, 2134, 2135); sec. 114(f), Pub. L. 97-
425, 96 Stat. 2213, as amended (42 U.S.C. 10143(f)); sec. 102, Pub. 
L. 91-190, 83 Stat. 853, as amended (42 U.S.C. 4332); sec. 301, 88 
Stat. 1248 (42 U.S.C. 5871).
    Sections 2.102, 2.103, 2.104, 2.105, 2.321 also issued under 
secs. 102, 103, 104, 105, 183i, 189, 68 Stat. 936, 937, 938, 954, 
955, as amended (42 U.S.C. 2132, 2133, 2134, 2135, 2233, 2239). 
Section 2.105 also issued under Pub. L. 97-415, 96 Stat. 2073 (42 
U.S.C. 2239). Sections 2.200-2.206 also issued under secs. 161b, i, 
o, 182, 186, 234, 68 Stat. 948-951, 955, 83 Stat. 444, as amended 
(42 U.S.C. 2201 (b), (i), (o), 2236, 2282); sec. 206, 88 Stat 1246 
(42 U.S.C. 5846). Section 2.205(j) also issued under Pub. L. 101-
410, 104 Stat. 90, as amended by section 3100(s), Pub. L. 104-134, 
110 Stat. 1321-373 (28 U.S.C. 2461 note). Subpart C also issued 
under sec. 189, 68 Stat. 955 (42 U.S.C. 2239). Section 2.301 also 
issued under 5 U.S.C. 554. Sections 2.343, 2.346, 2.712 also issued 
under 5 U.S.C. 557. Section 2.340 also issued under secs. 135, 141, 
Pub. L. 97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161). 
Section 2.390 also issued under sec. 103, 68 Stat. 936, as amended 
(42 U.S.C. 2133) and 5 U.S.C. 552. Sections 2.600-2.606 also issued 
under sec. 102, Pub. L. 91-190, 83 Stat. 853, as amended (42 U.S.C. 
4332). Sections 2.800 and 2.808 also issued under 5 U.S.C. 553. 
Section 2.809 also issued under 5 U.S.C. 553, and sec. 29, Pub. L. 
85-256, 71 Stat. 579, as amended (42 U.S.C. 2039). Subpart K also 
issued under sec. 189, 68 Stat. 955 (42 U.S.C. 2239); sec. 134, Pub. 
L. 97-425, 96 Stat. 2230 (42 U.S.C. 10154). Subpart L also issued 
under sec. 189, 68 Stat. 955 (42 U.S.C. 2239). Subpart M also issued 
under sec. 184 (42 U.S.C. 2234) and sec. 189, 68 Stat. 955 (42 
U.S.C. 2239). Subpart N also issued under sec. 189, 68 Stat. 955 (42 
U.S.C. 2239. Appendix A also issued under sec. 6, Pub. L. 91-550, 84 
Stat. 1473 (42 U.S.C. 2135).

    2. In Sec.  2.340, paragraph (j) is revised to read as follows:


Sec.  2.340  Initial decision in certain contested proceedings; 
immediate effectiveness of initial decisions; issuance of 
authorizations, permits, and licenses.

* * * * *
    (j) Issuance of finding on acceptance criteria under 10 CFR 52.103. 
The Commission, the Director of New Reactors, or the Director of 
Nuclear Reactor Regulation, as appropriate, shall make the finding 
under 10 CFR 52.103(g) that acceptance criteria in a combined license 
are met within 10 days from the date of the presiding officer's initial 
decision:
    (1) If the Commission or the appropriate Director is otherwise able 
to make the finding under 10 CFR 52.103(g) that the prescribed 
acceptance criteria are met for those acceptance criteria not within 
the scope of the initial decision of the presiding officer;

[[Page 27935]]

    (2) If the presiding officer's initial decision, with respect to 
contentions that the prescribed acceptance criteria have not been met, 
finds that those acceptance criteria have been met, and the Commission 
or the appropriate Director thereafter is able to make the finding that 
those acceptance criteria are met;
    (3) If the presiding officer's initial decision, with respect to 
contentions that the prescribed acceptance criteria will not be met, 
finds that those acceptance criteria will be met, and the Commission or 
the appropriate Director thereafter is able to make the finding that 
those acceptance criteria are met; and
    (4) Notwithstanding the pendency of a petition for reconsideration 
under 10 CFR 2.345, a petition for review under 10 CFR 2.341, or a 
motion for stay under 10 CFR 2.342, or the filing of a petition under 
10 CFR 2.206.
* * * * *

PART 52--LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER 
PLANTS

    3. The authority citation for part 52 continues to read as follows:

    Authority:  Secs. 103, 104, 161, 182, 183, 185, 186, 189, 68 
Stat. 936, 948, 953, 954, 955, 956, as amended, sec. 234, 83 Stat. 
444, as amended (42 U.S.C. 2133, 2201, 2232, 2233, 2235, 2236, 2239, 
2282); secs. 201, 202, 206, 88 Stat. 1242, 1244, 1246, as amended 
(42 U.S.C. 5841, 5842, 5846); sec. 1704, 112 Stat. 2750 (44 U.S.C. 
3504 note); Energy Policy Act of 2005, Pub. L. No. 109-58, 119 Stat. 
594 (2005), Secs. 147 and 149 of the Atomic Energy Act.

    4. Revise Sec.  52.99 to read as follows:


Sec.  52.99  Inspection during construction; ITAAC schedules and 
notifications; NRC notices.

    (a) Licensee schedule for completing inspections, tests, or 
analyses. 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 at 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) Licensee and applicant conduct of activities subject to ITAAC. 
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 preoperational activities, even 
though the NRC may not have found that any one of the prescribed 
acceptance criteria are met.
    (c) Licensee notifications. (1) ITAAC closure notification. The 
licensee shall notify the NRC that prescribed inspections, tests, and 
analyses have been performed and that the prescribed acceptance 
criteria are 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 are 
met.
    (2) ITAAC post-closure notifications. Following the licensee's 
ITAAC closure notifications under paragraph (c)(1) of this section 
until the Commission makes the finding under 10 CFR 52.103(g), the 
licensee shall notify the NRC, in a timely manner, of new information 
that materially alters the bases for determining that either 
inspections, tests, or analyses were performed as required, or that 
acceptance criteria are met. The notification must 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.
    (3) Uncompleted ITAAC notification. 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 are met.
    (4) All ITAAC complete notification. The licensee shall notify the 
NRC that all ITAAC are complete.
    (d) Licensee determination of non-compliance with ITAAC. (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 prescribed acceptance criteria are 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 10 CFR 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 prescribed acceptance criteria 
are met, the licensee may take corrective actions to successfully 
complete that ITAAC or request a license amendment under 10 CFR 
52.98(f).
    (e) NRC inspection, publication of notices, and availability of 
licensee notifications. 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 10 CFR 52.103(a), the NRC shall publish notices in 
the Federal Register of the NRC staff's determination of the successful 
completion of inspections, tests, and analyses.
    (2) The NRC shall make publicly available the licensee 
notifications under paragraph (c) of this section. The NRC shall make 
publicly available the licensee notifications under paragraphs (c)(1) 
through (4) of this section no later than the date of publication of 
the notice of intended operation required by 10 CFR 52.103(a).

    Dated at Rockville, Maryland, this 6th day of May 2011.

    For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2011-11679 Filed 5-12-11; 8:45 am]
BILLING CODE 7590-01-P