Requirements for Maintenance of Inspections, Tests, Analyses, and Acceptance Criteria, 27925-27935 [2011-11679]
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Federal Register / Vol. 76, No. 93 / Friday, May 13, 2011 / Proposed Rules
‘‘Industry Guideline for the ITAAC
Closure Process under 10 CFR Part 52,’’
Revision 4, issued July 2010, for the
implementation of 10 CFR 52.99,
‘‘Inspection during Construction.’’
Dated at Rockville, Maryland, this 4th day
of May 2011.
For the Nuclear Regulatory Commission.
Harriet Karagiannis,
Acting Chief, Regulatory Guide Development
Branch, Division of Engineering, Office of
Nuclear Regulatory Research.
[FR Doc. 2011–11678 Filed 5–12–11; 8:45 am]
BILLING CODE 7590–01–P
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
Nuclear Regulatory
Commission.
ACTION: Proposed rule.
AGENCY:
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
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SUMMARY:
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comments by any one of the following
methods:
• Federal Rulemaking Web site: Go to
https://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:
Carol.Gallagher@nrc.gov.
• Mail comments to: Secretary, U.S.
Nuclear Regulatory Commission,
Washington, DC 20555–0001, Attn:
Rulemakings and Adjudications Staff.
• E-mail comments to:
Rulemaking.Comments@nrc.gov. 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:
Earl.Libby@nrc.gov.
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 https://
www.regulations.gov. Because your
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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
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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).
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
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.
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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
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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
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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.
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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
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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
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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 postclosure 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.’’
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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 postclosure 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).
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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 postclosure 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
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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.
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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.
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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
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27929
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-bysection 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
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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.
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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
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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
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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
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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.
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• 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
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27931
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.
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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 https://
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
pdr.resource@nrc.gov.
• Federal Rulemaking Web site:
Public comments and supporting
materials related to this proposed rule
can be found at https://
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:
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Document
PDR
Web
SECY–09–0119, ‘‘Staff Progress in Resolving Issues Associated with Inspections, Tests,
Analyses and Acceptance Criteria’’ (August 26, 2009).
SRM–M090922—Staff Requirements—Periodic 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 Program for ITAAC Management’’ .............................
Regulatory Guide 1.215, ‘‘Guidance for ITAAC Closure Under 10 CFR Part 52,’’ Revision 0
(October 31, 2009).
NEI 08–01, ‘‘Industry Guideline for the ITAAC Closure Process Under 10 CFR Part 52,’’ Revision 3 (January 2009).
NEI 08–01, ‘‘Industry Guideline for the ITAAC Closure Process Under 10 CFR Part 52,’’ Revision 4.
Regulatory Analysis for Proposed Rule—Requirements for Maintenance of Inspections,
Tests, Analyses, and Acceptance Criteria (February 2011).
NUREG/BR–0058, ‘‘Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission,’’ Revision 4 (September 2004).
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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.
WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS
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).
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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 onetime 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
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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,
https://www.nrc.gov/public-involve/doccomment/omb/, 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
Infocollects.Resource@NRC.gov 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
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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 https://
www.regulations.gov by searching for
Docket ID NRC–2010–0012.
WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS
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.
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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).
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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 § 2.340, paragraph (j) is revised
to read as follows:
§ 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;
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(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 § 52.99 to read as follows:
WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS
§ 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
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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 noncompliance with ITAAC. (1) In the event
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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
SMALL BUSINESS ADMINISTRATION
13 CFR Part 121
RIN 3245–AG08
Small Business Size Standards:
Transportation and Warehousing
U.S. Small Business
Administration.
ACTION: Proposed rule.
AGENCY:
The U.S. Small Business
Administration (SBA) proposes to
increase small business size standards
SUMMARY:
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Agencies
[Federal Register Volume 76, Number 93 (Friday, May 13, 2011)]
[Proposed Rules]
[Pages 27925-27935]
From the Federal Register Online via the Government Printing 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 https://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: Carol.Gallagher@nrc.gov.
Mail comments to: Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, Attn: Rulemakings and
Adjudications Staff.
E-mail comments to: Rulemaking.Comments@nrc.gov. 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: Earl.Libby@nrc.gov.
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 https://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).
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\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.
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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
https://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
pdr.resource@nrc.gov.
Federal Rulemaking Web site: Public comments and
supporting materials related to this proposed rule can be found at
https://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, https://www.nrc.gov/public-involve/doc-comment/omb/, 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
Infocollects.Resource@NRC.gov and to the Desk Officer, Christine Kymn,
Office of Information and Regulatory Affairs, NEOB-10202 (