Licenses, Certifications, and Approvals for Nuclear Power Plants, 49352-49566 [07-3861]
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49352
Federal Register / Vol. 72, No. 166 / Tuesday, August 28, 2007 / Rules and Regulations
NUCLEAR REGULATORY
COMMISSION
10 CFR Parts 1, 2, 10, 19, 20, 21, 25,
26, 50, 51, 52, 54, 55, 72, 73, 75, 95, 140,
170, and 171
RIN 3150–AG24
Licenses, Certifications, and
Approvals for Nuclear Power Plants
Nuclear Regulatory
Commission.
ACTION: Final rule.
AGENCY:
rwilkins on PROD1PC63 with RULES2
SUMMARY: The Nuclear Regulatory
Commission (NRC) is amending its
regulations by revising the provisions
applicable to the licensing and approval
processes for nuclear power plants (i.e.,
early site permit, standard design
approval, standard design certification,
combined license, and manufacturing
license). These amendments clarify the
applicability of various requirements to
each of the licensing processes by
making necessary conforming
amendments throughout the NRC’s
regulations to enhance the NRC’s
regulatory effectiveness and efficiency
in implementing its licensing and
approval processes. The NRC has
considered and resolved the public
comments.
DATES: The effective date is September
27, 2007.
FOR FURTHER INFORMATION CONTACT:
Nanette V. Gilles, Office of New
Reactors, U.S. Nuclear Regulatory
Commission, Washington, DC 20555–
0001, telephone 301–415–1180, e-mail
nvg@nrc.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A. Development of Proposed Rule
B. Publication of Revised Proposed Rule
II. Overview of Public Comments
III. Reorganization of Part 52 and Conforming
Changes in the NRC’s Regulations
IV. Responses to Specific Requests for
Comments
V. Discussion of Substantive Changes and
Responses to Significant Comments
A. Introduction
B. Testing Requirements for Advanced
Reactors
C. Changes to 10 CFR Part 52
D. Changes to 10 CFR Part 50
E. Change to 10 CFR Part 1
F. Changes to 10 CFR Part 2
G. Changes to 10 CFR Part 10
H. Changes to 10 CFR Part 19
I. Changes to 10 CFR Part 20
J. Changes to 10 CFR Part 21
K. Change to 10 CFR Part 25
L. Changes to 10 CFR Part 26
M. Changes to 10 CFR Part 51
N. Changes to 10 CFR Part 54
O. Changes to 10 CFR Part 55
P. Changes to 10 CFR Part 72
Q. Changes to 10 CFR Part 73
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R. Change to 10 CFR Part 75
S. Changes to 10 CFR Part 95
T. Changes to 10 CFR Part 140
U. Changes to 10 CFR Part 170
V. Changes to 10 CFR Part 171
VI. Section-by-Section Analysis
VII. Availability of Documents
VIII. Agreement State Compatibility
IX. Voluntary Consensus Standards
X. Environmental Impact—Categorical
Exclusion
XI. Paperwork Reduction Act Statement
XII. Regulatory Analysis
XIII. Regulatory Flexibility Certification
XIV. Backfit Analysis
XV. Congressional Review Act
I. Background
A. Development of Proposed Rule
On July 3, 2003 (68 FR 40026), the
NRC published a proposed rulemaking
that would clarify and/or correct
miscellaneous parts of the NRC’s
regulations; update 10 CFR part 52 in its
entirety; and incorporate stakeholder
comments. On March 13, 2006 (71 FR
12781), the NRC issued a revised
proposed rule that would rewrite part
52, make changes throughout the
Commission’s regulations to ensure that
all licensing processes in part 52 are
addressed, and clarify the applicability
of various requirements to each of the
processes in part 52 (i.e., early site
permit, standard design approval,
standard design certification, combined
license, and manufacturing license).
This proposed rule superseded the July
3, 2003, proposed rule.
The NRC issued 10 CFR part 52 on
April 18, 1989 (54 FR 15372), to reform
the NRC’s licensing process for future
nuclear power plants. The rule added
alternative licensing processes in 10
CFR part 52 for early site permits,
standard design certifications, and
combined licenses. These were
additions to the two-step licensing
process that already existed in 10 CFR
part 50. The processes in 10 CFR part
52 allow for resolving safety and
environmental issues early in licensing
proceedings and were intended to
enhance the safety and reliability of
nuclear power plants through
standardization. Subsequently, the NRC
certified four nuclear power plant
designs under subpart B of 10 CFR part
52—the U.S. Advanced Boiling Water
Reactor (ABWR) (62 FR 25800; May 12,
1997), the System 80+ (62 FR 27840;
May 21, 1997), the AP600 (64 FR 72002;
December 23, 1999), and the AP1000 (71
FR 4464; January 27, 2006). These
design certifications are codified in
appendices A, B, C, and D of 10 CFR
part 52, respectively.
The NRC planned to update 10 CFR
part 52 after using the standard design
certification process. The proposed
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rulemaking action began with the
issuance of SECY–98–282, ‘‘Part 52
Rulemaking Plan,’’ on December 4,
1998. The Commission issued a staff
requirements memorandum (SRM) on
January 14, 1999 (SRM on SECY–98–
282), approving the NRC staff’s plan for
revising 10 CFR part 52. Subsequently,
the NRC obtained considerable
stakeholder comment on its planned
action, conducted three public meetings
on the proposed rulemaking, and twice
posted draft rule language on the NRC’s
rulemaking Web site before issuance of
the July 2003 proposed rule.
B. Publication of Revised Proposed Rule
A number of factors led the NRC to
question whether the July 2003
proposed rule would meet the NRC’s
objective of improving the effectiveness
of its processes for licensing future
nuclear power plants. First, public
comments identified several concerns
about whether the proposed rule
adequately addressed the relationship
between part 50 and part 52, and
whether it clearly specified the
applicable regulatory requirements for
each of the licensing and approval
processes in part 52. In addition, as a
result of the NRC staff’s review of the
first three early site permit applications,
the staff gained additional insights into
the early site permit process. The NRC
also had the benefit of public meetings
with external stakeholders on NRC staff
guidance for the early site permit and
combined license processes. As a result,
the NRC decided that a substantial
rewrite and expansion of the July 2003
proposed rulemaking was desirable so
that the agency may more effectively
and efficiently implement the licensing
and approval processes for future
nuclear power plants under part 52.
Accordingly, the Commission decided
to revise the July 2003 proposed rule
and published a revised proposed rule
for public comment on March 13, 2006.
This revised proposed rule contained a
rewrite of part 52, as well as changes
throughout the NRC’s regulations, to
ensure that all licensing and approval
processes in part 52 are addressed, and
to clarify the applicability of various
requirements to each of the processes in
part 52. In light of the substantial
rewrite of the July 2003 proposed rule,
the expansion of the scope of the
rulemaking, and the NRC’s decision to
publish the revised proposed rule for
public comment, the NRC decided that
developing responses to comments
received on the July 2003 proposed rule
would not be an effective use of agency
resources. The NRC requested that
commenters on the July 2003 proposed
rule who believed that their earlier
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comments were not adequately
addressed in the March 2006 proposed
rule resubmit their comments.
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II. Overview of Public Comments
The public comment period for the
March 2006 revised proposed rule
expired on May 30, 2006. The NRC
received 19 comment letters from
industry stakeholders, other Federal
agencies, and individuals during the
public comment period. The NRC has
considered and resolved all of the
public comments received during the
comment period and has made
modifications to the rule language, as
appropriate. The NRC has prepared a
separate report, entitled Comment
Summary Report: 10 CFR Part 52,
Licenses, Certifications, and Approvals
for Nuclear Power Plants, in which it
summarizes the public comments
received and discusses the agency’s
disposition of each comment. This
report is available to the public as
discussed in Section VII of the
Supplementary Information of this
document. The resolution of significant
public comments is also discussed in
Section IV, Responses to Specific
Requests for Comments and, Section V,
Discussion of Substantive Changes and
Responses to Significant Comments in
this document.
III. Reorganization of Part 52 and
Conforming Changes in the NRC’s
Regulations
Since the adoption of 10 CFR part 52
in 1989, the NRC and its external
stakeholders identified a number of
interrelated issues and concerns with
the licensing process. One significant
concern was that the overall regulatory
relationship between part 50 and part 52
was not always clear. In the former
rules, it was often difficult to tell
whether general regulatory provisions in
part 50 apply to part 52. One example
is whether the absence of an exemption
provision in part 52 denotes the NRC’s
determination that exemptions from
part 52 requirements are not available,
or that these exemptions are controlled
by § 50.12. A related problem is the
current lack of specific delineation of
the applicability of NRC requirements
throughout 10 CFR Chapter I to the
licensing and approval processes in part
52. For example, the indemnity and
insurance provisions in part 140 were
not revised to address their applicability
to applicants for and holders of
combined licenses under subpart C of
part 52. Even where part 52 provisions
referenced specific requirements in part
50, it was not always clear from the
language of the part 50 requirement how
that requirement applied to the part 52
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processes. For example, § 52.47(a)(1)(i)
provides that a standard design
certification application must contain
the ‘‘technical information which is
required of applicants for construction
permits and operating licenses by 10
CFR* * *part 50* * *and which is
technically relevant to the design and
not site-specific.’’
The language did not explicitly
identify the part 50 requirements that
are ‘‘technically relevant to the design.’’
Even where a specific regulation in part
50 is identified as a requirement, the
language of the referenced regulation
itself was not changed to reflect the
specific requirements as applied to the
part 52 processes. For example,
§ 52.79(b) provides that the application
must contain the ‘‘technically relevant
information required of applicants for
an operating license required by 10 CFR
50.34.’’ Other than the fact that this
language shares the problem discussed
earlier of what constitutes a ‘‘technically
relevant’’ requirement, § 50.34(b) is
based upon the two-step licensing
process whereby certain important
information is submitted at the
construction permit stage, and then
supplemented with more detailed
information at the operating license
stage. Thus, it could be asserted that
certain information that must be
submitted in the construction permit
application, e.g., the ‘‘principal design
criteria for the facility’’ required by
§ 50.34(a)(3)(i), may be regarded as not
required to be submitted for a combined
license application under the former
version of part 52.
Another potential source of confusion
is that the different subparts of part 52
and the appendices on standard design
approvals and manufacturing licenses
are not organized using the same format
of individual sections (e.g., ‘‘Scope of
subpart,’’ followed by ‘‘Relationship to
other subparts,’’ followed by ‘‘Filing of
application’’). Moreover, the
organization and textual content of
identically-titled sections differs among
the subparts, and with appendices M, N,
O, and Q, which establish additional
licensing and approval processes. While
these differences do not constitute an
insurmountable problem to their use
and application, it became apparent to
the Commission that adoption of a
common format, organization, and
textual content would enhance usability
and result in increased regulatory
effectiveness and efficiency.
In the 2003 proposed rule, the NRC
proposed several changes that were
intended to address some (but not all)
of these issues. However, based upon
comments received on the 2003
proposed rule, the NRC’s experience to
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date with early site permit applications,
interactions with external stakeholders
concerning NRC guidance for combined
license applications, and NRC’s
screening of 10 CFR Chapter I
requirements following the receipt of
public comments on the 2003 proposed
rule, the NRC concluded that the 2003
proposed rule would not adequately
address and resolve these issues.
Accordingly, in the March 13, 2006,
proposed rule the NRC took a more
comprehensive approach to addressing
these issues by reorganizing part 52,
implementing a uniform format and
content for each of the subparts in part
52, using consistent wording and
organization of sections in each of the
subparts, and making conforming
changes throughout 10 CFR Chapter I to
reflect the licensing and approval
processes in part 52. The NRC also
coordinated and reconciled differences
in wording among provisions in parts 2,
50, 51, and 52 to provide consistent
terminology throughout all of the
regulations affecting part 52. Under the
NRC’s reorganization of part 52, the
existing appendices O and M on
standard design approvals and
manufacturing licenses, respectively,
have been redesignated as new subparts
in part 52. Redesignating these
appendices as subparts in part 52 has
resulted in a consistent format and
organization of the requirements
applicable to each of the licensing and
approval processes. In addition, the
redesignation clarifies that each of the
licensing and approval processes in
these appendices are available to
potential applicants as an alternative to
the processes in part 50 (construction
permit and operating license) and the
existing subparts A through C of part 52.
The Commission does not, by virtue of
this redesignation, either favor or
disfavor the processes in the former
appendices M and O of part 52. Rather,
the Commission is standardizing the
format and organization of part 52, and
clarifying the full range of alternatives
that are available under part 52 for use
by potential applicants. Consistent with
the broad scope of part 52, the NRC has
retitled 10 CFR part 52 as ‘‘Licenses,
Certifications, and Approvals for
Nuclear Power Plants.’’
The NRC has also reorganized and
expanded the scope of the
administrative and general regulatory
provisions that precede the part 52
subparts by adding new sections on
written communications (analogous to
§ 50.4), employee protection (analogous
to § 50.7), completeness and accuracy of
information (analogous to § 50.9),
exemptions (analogous to § 50.12),
combining licenses (analogous to
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§ 50.52), jurisdictional limits (analogous
to § 50.53), and attacks and destructive
acts (analogous to § 50.13). The NRC
believes that adding the new sections to
part 52 rather than revising the
comparable sections in part 50 is more
consistent with the general format and
content of the Commission’s regulations
in each of the parts of Title 10. The NRC
considered whether the numbering of
the newly-added sections to part 52—in
particular, the provisions on deliberate
misconduct, employee protection, and
completeness and accuracy of
information—should match the
numbering of the comparable sections
in part 50. While this may have some
benefit, the NRC ultimately decided not
to adopt such a course for several
reasons. First, other parts of the NRC’s
regulations in 10 CFR Chapter I do not
maintain the same numbering scheme.
Rather, it appears that the NRC
attempted to maintain the order in
which these sections are listed in each
part. Second, there are other provisions
in part 50 for which a comparable
provision needed to be added to the
general and administrative provisions in
part 52, but for which it would be
impossible to maintain the same
numbering (for example, § 50.13 (attacks
and destructive acts); § 50.32
(elimination of repetition); § 50.52
(combining licenses)), unless the
substantive provisions of part 52,
beginning with § 52.12, were changed.1
Maintaining in part 52 the numbering
scheme for some, but not all,
comparable sections from part 50
ultimately would be viewed as
haphazard and arbitrary. Finally, the
NRC does not believe that external
stakeholders who must constantly refer
to part 52 will be confused by any
difference in numbering of the three
sections, given that there are other
comparable provisions for which the
numbering is necessarily different
between parts 50 and 52. For these
reasons, the NRC did not attempt to
match in the final part 52 rule the
numbering of the comparable sections
in part 50.
Appendix N, which addresses
duplicate design licenses, has been
retained in both part 52 and part 50 to
afford future applicants flexibility and
to retain the possibility of achieving
1 The NRC notes, in this regard that nuclear
industry stakeholders adversely commented on the
revised numbering scheme as set forth in the 2003
proposed part 52 rule. They suggested that the NRC
retain, to the greatest extent posible, the numbering
of the then existing part 52. Inasmuch as § 52.12 is
the first substantive provision of the former party
52, this placed an upper bound on the number of
sections available for general provisions—that is
§ 52.0 through 52.11.
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regulatory efficiencies in part 52
combined license proceedings. Since
the preparation of the March 2006
proposed rule, several industry groups
have announced their intention to seek
combined licenses utilizing the same
design. In view of this industry
development, the NRC believes that
there is potential utility to keeping the
option of appendix N open to potential
combined license applicants.
Accordingly, the NRC is retaining in
part 52 the procedural alternative
provided in appendix N, and revising its
language to make its provisions
applicable to combined licenses using
identical designs. Appendix Q, which
addresses early staff review of site
suitability issues, is being removed from
part 52 but retained in part 50.
Appendix Q provides for NRC staff
issuance of a staff site report on site
suitability issues with respect to a
specific site for which a potential
applicant seeks the NRC staff’s views.
The staff site report is issued after
receiving and considering the comments
of Federal, State, and local agencies and
interested persons, as well as the views
of the Advisory Committee on Reactor
Safeguards (ACRS), but only if site
safety issues are raised. The staff site
report does not bind the Commission or
a presiding officer in any hearing under
part 2. This process is separate from the
early site permit process in subpart A of
part 52. The NRC recognizes the
apparent redundancy between the early
review of site suitability issues and the
early site permit process. Accordingly,
the NRC is removing appendix Q from
part 52 and retaining it only in part 50.
Inasmuch as the NRC may, in the
future, adopt other regulatory processes
for nuclear power plants, the NRC has
reserved several subparts in part 52 to
accommodate additional licensing
processes that may be adopted by the
NRC. The NRC used a standard format
and content for revising the regulations
in the existing subparts and developing
the new subparts that address the
former appendices M and O. The
standard format and content was
modeled on the existing organization
and content of subparts A and C.
Appendix N of part 52, however, has
not been revised in that fashion because
of time constraints in developing the
final rule.
Perhaps most importantly, the NRC
has reviewed the existing regulations in
10 CFR Chapter I to determine if the
existing regulations must be modified to
reflect the licensing and approval
processes in part 52. First, the NRC
determined whether an existing
regulatory provision must, by virtue of
a statutory requirement or regulatory
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necessity, be extended to address a part
52 process, and, if so, how the
regulatory provision should apply.
Second, in situations where the NRC
has some discretion, the NRC
determined whether there were policy
or regulatory reasons to extend the
existing regulations to each of the part
52 processes. Most of the conforming
changes in this final rule occur in 10
CFR part 50. In making conforming
changes involving 10 CFR part 50
provisions, the NRC has adopted the
general principle of keeping the
technical requirements in 10 CFR part
50 and maintaining all applicable
procedural requirements in part 52.
However, due to the complexity of some
provisions in 10 CFR part 50 (e.g.,
§ 50.34), this principle could not be
universally followed. A description of,
and bases for, the substantive
conforming changes for each affected
part is provided in Section V of this
document.
To highlight the relationship between
the requirements in part 52 of this final
rule and the requirements in existing
part 52, the NRC is making two crossreference tables available to the public.
These tables can be found on NRC’s
Agencywide Documents Access and
Management System (ADAMS) at
accession number ML062550U0246.
Table 1 matches each part 52
requirement in this final rule with its
counterpart in the existing rule. Table 2
is a reverse cross-reference table which
identifies the section of the existing part
52 requirements from which each part
52 requirement in this final rule was
derived.
IV. Responses to Specific Requests for
Comments
In Section V of the Statements of
Consideration for the March 13, 2006,
proposed rule, the NRC posed 15
questions for which it solicited
stakeholder comments. In the following
paragraphs, these questions are restated,
comments received from stakeholders
are summarized, and the NRC resolution
of the public comments is presented.
Question 1: General Provisions. Create
new subpart for part 50. In response to
several commenters’ concerns about the
clarity of the applicability of part 50
provisions to part 52, the Commission
has added provisions to part 52 (§§ 52.0
through 52.11) that are analogues to
comparable provisions in part 50.
Another possible way of addressing the
commenters’ concerns would be to
transfer all the provisions in part 52 to
a new subpart (e.g., subpart M) of part
50, and retain the existing numbering
sequence for the current part 52 with
the addition of a prefix (e.g., proposed
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50.1001 = current 52.1). The
Commission is considering adopting
this alternative proposal in the final rule
and is interested in whether
stakeholders regard this as a more
desirable approach for minimizing the
ambiguity of the relationship between
part 50 and part 52.
Commenters’ Response: Some
commenters stated the clarity of the
regulations would not be enhanced by
moving provisions from part 52 to a new
subpart of part 50. The commenters
argued that in addition to not
eliminating existing confusion, such a
content shift would create new
confusion because current documents
referencing part 52 would become
‘‘obsolete.’’
NRC Response: The NRC has decided
not to transfer provisions from part 52
to a new subpart in part 50, inasmuch
as: (1) no commenter favored
transferring provisions from part 52 to a
new subpart in part 50, (2) the
approaches are legally equivalent, and
(3) nearly 17 years has passed since the
Commission adopted the approach of
establishing early site permits, standard
design certifications, and combined
licenses in a new part 52, and a
reorganization of the regulations at this
time may engender confusion without
any compensating benefits in clarity,
regulatory stability and predictability, or
efficiency.
Question 2: Currently, §§ 52.17(b) of
subpart A of 10 CFR part 52 requires
that an early site permit application
identify physical characteristics that
could pose a significant impediment to
the development of emergency plans.
An early site permit application may
also propose major features of the
emergency plans or propose complete
and integrated emergency plans in
accordance with the applicable
standards of § 50.47 and the
requirements of appendix E of 10 CFR
part 50. The requirements in § 52.17 do
not further define major features of
emergency plans. Section 52.18 of
subpart A requires the Commission to
determine, after consultation with the
Federal Emergency Management
Agency, whether any major features of
emergency plans submitted by the
applicant under § 52.17(b) are
acceptable. Section 52.18 does not
provide any further explanation of the
Commission’s criteria for judging the
acceptability of major features of
emergency plans.
The Commission has concluded, after
undergoing the review of the first three
early site permit applications, that
Commission review and acceptance of
major features of emergency plans may
not achieve the same level of finality for
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emergency preparedness issues at the
early site permit stage as that associated
with a reasonable assurance finding of
complete and integrated plans.
Therefore, the Commission is
considering modifying in the final rule
the early site permit process in
proposed subpart A to remove the
option for applicants to propose major
features of emergency plans in early site
permit applications and requests public
comment on this alternative. The NRC
believes that, if the option for early site
permit applicants to include major
features of emergency plans is to be
retained, it would be useful to further
define in the final rule what a major
feature is and establish a clearer level of
finality associated with the NRC’s
review and acceptance of major features
of emergency plans. If the option to
include major features of emergency
plans is retained in the final rule, the
NRC would define major features of
emergency plans as follows:
Major features of the emergency plans
means the aspects of those plans necessary
to: (1) address one or more of the sixteen
standards in § 50.47(b), and (2) describe the
emergency planning zones as required in
§§ 50.33(g), 50.47(c)(2), and appendix E to 10
CFR part 50.
In addition, the NRC is considering
adopting in the final rule the
requirement that major features of
emergency plans must include the
proposed inspections, tests, and
analyses that the holder of a combined
license referencing the early site permit
shall perform, and the acceptance
criteria that are necessary and sufficient
to provide reasonable assurance that, if
the inspections, tests, and analyses are
performed and the acceptance criteria
met, the facility has been constructed
and will operate in conformity with the
license, the provisions of the Atomic
Energy Act (AEA), and the NRC’s
regulations, insofar as they relate to the
major features under review.
The NRC believes that, under this
alternative, the level of finality
associated with each major feature that
the Commission found acceptable
would be equivalent, for that individual
major feature, to the level of finality
associated with a reasonable assurance
finding by the NRC for a complete and
integrated plan, including inspections,
tests, analyses, and acceptance criteria
(ITAAC), at the early site permit stage.
Commenters’ Response: Several
commenters suggested the current
process for addressing major features of
emergency plans (EP) in the early site
permit (ESP) be retained without
modification. Some commenters
expressed a fear that the loss of this
option would result in a loss of
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49355
flexibility to achieve ‘‘finality’’ without
producing a comprehensive EP. Some
commenters identified a need to clarify
the definition of ‘‘major features’’ of the
EP to make it less restrictive. Some
commenters believed that the approved
major features were acceptable elements
of a ‘‘complete and integrated
emergency plan that would be
considered later.’’ Some commenters
believed the information should not be
reviewed again during the COL process,
which would instead focus on (1) the
integration of these major features with
information necessary to support the
‘‘reasonable assurance finding,’’ and (2)
the updating of EP information required
by § 52.39(b).
NRC Response: Based on the
commenters’ feedback, the NRC has
decided to retain the current process for
addressing major features of emergency
plans in an ESP without modification.
The NRC agrees that it should clarify the
definition of ‘‘major features’’ and has
done so by adding the definition
suggested by the commenters to § 52.1
in the final rule. For a detailed
discussion of the basis for this change,
see Section V.C.5.b of the
Supplementary Information section of
this document which discusses changes
to § 52.1, ‘‘Definitions.’’
Question 3: As indicated in Section
IV, Discussion of Substantive Changes
(in the March 13, 2006, proposed rule),
the NRC is proposing to remove
appendix Q to part 52 entirely from part
52 and retain it in part 50. Currently,
appendix Q to part 52 provides for NRC
staff issuance of a staff site report on site
suitability issues with respect to a
specific site, for which a person (most
likely a potential applicant for a
construction permit or combined
license) seeks the NRC staff’s views. The
NRC is also considering removing, in
the final rule, the early site review
process in appendix Q to part 52 in its
entirety from the NRC’s regulations and
is interested in stakeholder feedback on
this alternative. One possible reason for
removing the early site review process
in its entirety is that potential nuclear
power plant applicants would use the
early site permit process in subpart A of
part 52, rather than the early site review
process as it currently exists in
appendix Q to parts 50 and 52. Also, in
cases where a combined license
applicant was interested in seeking NRC
staff review of selected site suitability
issues (as appendix Q to part 52 was
designed for), the applicant could
request a pre-application review of these
issues. The use of pre-application
reviews for selected issues has been
successfully used by applicants for
design certification. The NRC is
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especially interested in the views of
potential applicants for nuclear power
plant construction permits and
combined licenses as to whether there is
any value in retaining the early site
review process.
Commenters’ Response: Some
commenters expressed concern about
the loss of flexibility to assess site
suitability that would result from the
deletion of appendix Q from parts 50
and 52. These commenters believed that
appendix Q to parts 50 and 52 (in
conjunction with subpart F of 10 CFR
part 2) was important for allowing
‘‘critical path issues’’ to be reviewed
prior to submission of a combined
license (COL) application in instances
where prior completion of an ESP was
not feasible. Some commenters argued
for the efficiency of appendix Q to parts
50 and 52 and subpart F of part 2
because only applicant-selected issues
would be reviewed during these
processes. Some commenters
recommended changes be made to
specifically allow ESP and COL
applicants to reference an early site
review conducted in accordance with
appendix Q or subpart F. The
commenters stated that the NRC should
not delete the option for a part 52
applicant to reference a review
performed under appendix Q to 10 CFR
part 52.
NRC Response: After considering
these comments the NRC has decided to
go forward with removal of appendix Q
from part 52 in the final rule.
However, the NRC agrees that
§ 2.101(a–1) and subpart F of part 2
should be modified to allow applicants
for early site permits and combined
licenses under part 52 to take advantage
of those provisions. Both § 2.101(a–1)
and subpart F of part 2 have been
revised in the final rule, albeit
somewhat differently than the approach
recommended by the commenter.
Inasmuch as the revisions are to the
Commission’s rules of procedure and
practice, the Commission may adopt
them in final form without further
notice and comment, under the
rulemaking provisions of the APA, 5
U.S.C. 553(b)(A). The Commission
believes that sufficient flexibility will be
retained for future combined license
applicants with the preservation of the
provisions in § 2.101(a–1) and subpart F
of part 2 and that there is little value in
also retaining the provisions in
appendix Q.
Question 4: Under subpart F of part 52
of the proposed rule, the NRC proposes
to require approval of, and extend
finality to, the final design for a reactor
to be manufactured under a
manufacturing license. While the NRC
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will also review the acceptability of the
manufacturing license applicant’s
organization responsible for design and
manufacturing, as well as the quality
assurance (QA) program for design and
manufacturing, the proposed rule does
not provide a regulatory structure for
further extending the scope of NRC
review and issue finality to the
manufacturing process itself. The NRC
is considering extending regulatory
review approval, and consequently
expand issue finality, to the
manufacturing itself in the final rule.
There are two models that the
Commission is considering adopting if it
were to move in this direction. The first
would be an analogue to the subpart C
of part 52 combined license process,
whereby the NRC would review and
approve manufacturing ITAAC to be
included in the manufacturing license.
During the manufacturing of each
reactor, the NRC would verify at the
manufacturing location whether the
ITAAC have been conducted and the
acceptance criteria met. A NRC finding
of successful completion of all the
ITAAC would preclude any further
inspection of the acceptability of the
manufacture of the reactor at the site
where the manufactured reactor is to be
permanently sited and operated. The
NRC’s inspections and findings for the
combined license or operating license
would be limited to whether the reactor
had been emplaced in undamaged
condition (or damage had been
appropriately repaired) and all interface
requirements specified in the
manufacturing license had been met.
The NRC believes that it has authority
to issue a manufacturing license under
Section 161.h of the AEA.
The other model that the NRC could
adopt would be a combination of the
approval processes used by the Federal
Communications Commission (FCC)
and Federal Aviation Administration
(FAA) in approving the manufacture of
electronic devices and airplanes. The
NRC’s manufacturing license would
approve: (1) the design of the nuclear
power reactor to be manufactured; (2)
the specific manufacturing and quality
assurance/quality control processes and
procedures to be used during
manufacture; and (3) tests and
acceptance criteria for demonstrating
that the reactor has been properly
manufactured. To be completely
consistent with the FCC and FAA
models, the NRC would issue a
manufacturing license only after a
prototype of the reactor had been
constructed and tested to demonstrate
that all performance requirements (i.e.,
compliance with NRC requirements and
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manufacturer’s specifications) can be
met by the design to be approved for
manufacture.
The NRC requests public comment on
whether the manufacturing license
process in proposed subpart F of part 52
should be further extended in the final
rule to provide an option for NRC
approval of the manufacturing, and if
so, which model of regulatory oversight,
i.e., the combined license ITAAC model
or the FCC/FAA approval model, should
be used by the NRC. The NRC also seeks
public comment on whether an
opportunity for hearing is required by
the AEA in connection with a NRC
determination that the manufacturing
ITAAC have been successfully
completed.
Commenters’ Response: Some
commenters requested that applicants
for manufacturing licenses be allowed,
but not required, to use ITAAC to
ensure that an ‘‘as-manufactured plant
conforms to the important design
characteristics specified in the
application for the manufacturing
license.’’ Some commenters stated that
a manufacturing license for evolutionary
designs should be subject to proposed
§ 50.43(e) and should not require a
prototype. Some commenters stated that
manufacturing licenses should not be
subject to more stringent requirements
than design certifications.
NRC Response: The NRC has decided
to defer consideration of this alternative
on ITAAC, for several reasons. First, one
commenter’s proposal to allow ITAAC
for assuring that the as-manufactured
reactor ‘‘conforms to the important
design characteristics specified in the
application for the manufacturing
license,’’ raises questions about what
those ‘‘important design characteristics’’
might be, and why the ITAAC would be
so narrowly limited. The Commission
did not receive any in-depth comments
presenting arguments one way or the
other on the feasibility of developing
such ITAAC, and the potential legal
implications of, and technical
considerations with respect to, such a
finding by the manufacturer. Moreover,
it is clear that any regulatory process
that the Commission may adopt in
rulemaking would require further
opportunity for public comment, and
therefore could not be adopted in a final
part 52 rulemaking without substantial
delay. In light of the lack of any nearterm interest by any entity in obtaining
a manufacturing license, the
Commission has decided not to adopt
any provisions for ITAAC governing
approval of manufacturing in the final
part 52 rule. However, the Commission
would address these issues in a timely
fashion if raised in a rulemaking
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petition which demonstrated near-term
interest in an application for a
manufacturing license.
The Commission agrees with the
commenters’’ suggestions that
manufacturing licenses for evolutionary
designs should be subject to new
§ 50.43(e), and that under those
provisions a prototype would not be
prerequisite to issuance of a
manufacturing license for an
evolutionary design. Further discussion
is provided below in Testing
Requirements for Advanced Reactors.
Question 5: Currently, part 52 allows
an applicant for a construction permit to
reference either an early site permit
under subpart A of part 52 or a design
certification (DC) under subpart B of
part 52. Specifically, § 52.11 states that
subpart A of part 52 sets out the
requirements and procedures applicable
to NRC issuance of early site permits for
approval of a site or sites for one or
more nuclear power facilities separate
from the filing of an application for a
construction permit or combined license
for such a facility. Similarly, § 52.41
states that subpart B of part 52 sets out
the requirements and procedures
applicable to NRC issuance of
regulations granting standard design
certification for nuclear power facilities
separate from the filing of an
application for a construction permit or
combined license for the facility.
However, the current regulations in 10
CFR part 50 that address the application
for and granting of construction permits
do not make any reference to a
construction permit applicant’s ability
to reference either an early site permit
or a design certification. Also, the NRC
has not developed any guidance on how
the construction permit process would
incorporate an early site permit or
design certification, nor has the nuclear
power industry made any proposals for
the development of industry guidance
on this subject. The NRC has not
received any information from potential
applicants stating an intention to seek a
construction permit for the construction
of a future nuclear power plant. In
addition, the NRC recommends that
future applicants who want to construct
and operate a commercial nuclear
power facility use the combined license
process in subpart C of part 52.
Therefore, the NRC is considering
removing from part 52, in the final rule,
the provisions allowing a construction
permit applicant to reference an early
site permit or a design certification and
is interested in stakeholder feedback on
this alternative.
Commenters’ Response: Some
commenters stated the deletion of
provisions allowing a construction
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permit applicant to reference an ESP or
DC was ill-advised given the untested
nature of the COL process and the
resulting need to retain ‘‘regulatory
flexibility’’ to deal with unexpected
issues. As a contingency plan to buffer
against difficulties with COL process,
the commenters proposed the addition
of a provision in part 50 to specify that
a construction permit applicant could
reference a DC without the inclusion of
ITAAC. The commenters suggested that
in these instances, ‘‘the operating
license proceeding would need to find
under 10 CFR 50.57(a)(1) that
construction of the facility has been
substantially completed, in conformity
with the construction permit and the
application as amended, the provisions
of the Act, and the rules and regulations
of the Commission.’’ Commenters stated
that standard design should be final and
not open to review in the construction
permit and operating licenses
proceeding. Commenters requested a
construction permit applicant be able to
reference an ESP in the same way as
would a COL applicant.
NRC Response: Based on some of the
commenters’ responses to this question
and further consideration of the issue,
the NRC has decided not to make any
changes in the final rule to delete
provisions allowing a construction
permit applicant to reference an early
site permit or a design certification. The
NRC has also decided not to add any
additional provisions to part 50 or part
52 to address a construction permit
applicant’s ability to reference either a
design certification or an early site
permit. The NRC believes it is unlikely
that such a construction permit
application will be submitted, and the
NRC will handle any such applications
on a case-by-case basis. If such an
application were submitted, there are
many process issues that would need to
be carefully considered and would need
to be discussed with the applicant and
other stakeholders. In particular, the
previously certified designs all used
design acceptance criteria in lieu of
detailed design information. A process
for completing that design information
without using ITAAC would have to be
developed.
Question 6: The NRC is considering
revising § 52.103(a) in the final rule to
require the combined license holder to
notify the NRC of the licensee’s
scheduled date for loading of fuel into
a plant no later than 270 days before the
scheduled date, and to advise the NRC
every 30 days thereafter if the date has
changed and if so, the revised scheduled
date for loading of fuel. The initial
notification would facilitate timely NRC
publication of the notice required under
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§ 52.103(a) and NRC staff scheduling of
inspection and audit activities to
support NRC staff determinations of the
successful completion of ITAAC under
§ 52.99. The proposed updating would
also facilitate NRC staff scheduling of
those inspection and audit activities,
Commission completion of hearings
within the time frame allotted under
§ 52.103(e), and any Commission
determinations on petitions as provided
under § 52.103(f). The NRC requests
public comment on the benefits and
impacts (including information
collection and reporting burdens) that
would occur if the proposed
requirements were adopted.
Commenters’ Response: Some
commenters agreed with this concept.
However, they do not support a rule
change because they believe a rule
change is not necessary. Rather, they
believe that the concept should be
implemented via guidance rather than a
rule change. Additionally, following the
initial notification, a licensee should be
required to submit a follow-up 30-day
notification only if the schedule in the
prior notification has changed. It would
be unnecessarily burdensome to require
a licensee to submit notifications every
30 days stating that the schedule has not
changed.
NRC Response: The NRC has decided
to amend § 52.103(a) in the final rule to
ensure that the combined license holder
will notify the NRC of its scheduled
date for initial loading of fuel into a
plant no later than 270 days before the
scheduled date, and will notify the NRC
of updates to its schedule every 30 days
thereafter. The notification will
facilitate timely NRC publication of the
notice required under § 52.103(a),
completion of hearings within the time
frame allotted under § 52.103(e), and
completion of any Commission
determinations on petitions filed under
§ 52.103(f). The NRC believes that the
update notifications when the schedule
has not changed will not be
burdensome. Additional discussion on
this issue is provided in Section V.C.8.b
of the supplementary information in
this final rule.
Question 7: As discussed in Section
IV.C.6.f of the March 13, 2006, proposed
rule, the NRC is proposing to modify
§ 52.79(a) to add requirements for
descriptions of operational programs
that need to be included in the final
safety analysis report (FSAR) to allow a
reasonable assurance finding of
acceptability. This proposed
amendment is in support of the
Commission’s direction to the staff in
SRM–SECY–02–0067 dated September
11, 2002, ‘‘Inspections, Tests, Analyses,
and Acceptance Criteria for Operational
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Programs (Programmatic ITAAC),’’ that
a combined license applicant was not
required to have ITAAC for operational
programs if the applicant fully
described the operational program and
its implementation in the combined
license application. In this SRM, the
Commission stated:
rwilkins on PROD1PC63 with RULES2
[a]n ITAAC for a program should not be
necessary if the program and its
implementation are fully described in the
application and found to be acceptable by the
NRC at the COL stage. The burden is on the
applicant to provide the necessary and
sufficient programmatic information for
approval of the COL without ITAAC.
Accordingly, the NRC is proposing in
the final part 52 rulemaking to add
requirements to § 52.79 that combined
license applications contain
descriptions of operational programs. In
doing so, the Commission has taken into
account NEI’s proposal to address SRM–
SECY–04–0032 in its letter dated
August 31, 2005 (ML052510037).
However, the NRC is concerned that
there may be operational program
requirements that it has not captured in
its proposed § 52.79. Therefore, the NRC
is requesting public comment on
whether there are additional required
operational programs that should be
described in a combined license
application that are not identified in
proposed § 52.79. If additional required
operational programs are identified, the
Commission is considering adding them
to § 52.79 in the final rule.
Commenters’ Response: Some
commenters believed that requirements
for operational programs were sufficient
as proposed, and that no additional
operational programs needed to be
described in the COL application.
NRC Response: The NRC does not
agree that no additional operational
programs need to be described in a COL
application. During the preparation of
the final rule, the NRC discovered that
several of the operational programs
listed in SECY–05–0197 (October 28,
2005) were not addressed in proposed
§ 52.79. To ensure the list of
requirements for the contents of
applications is complete, the NRC is
adding several new provisions to
address operational programs in the
final rule. Specifically, the NRC is
adding requirements to § 52.79 for COL
applicants to include a description of:
(1) the process and effluent monitoring
and sampling program required by
appendix I to 10 CFR part 50
[§ 52.79(a)(16)(ii)]; (2) a training and
qualification plan in accordance with
the criteria set forth in appendix B to 10
CFR part 73 [§ 52.79(a)(36)(ii)]; (3) a
description of the radiation protection
program required by § 20.1101
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[§ 52.79(a)(39)]; (4) a description of the
fire protection program required by
§ 50.48 [§ 52.79(a)(40)]; and (5) a
description of the fitness-for-duty
program required by 10 CFR part 26
[§ 52.79(a)(44)]. During the preparation
of the final rule, the NRC also noticed
that it had not completely implemented
the Commission’s direction regarding
the treatment of operational programs in
a COL application because it had failed
to add requirements to address program
implementation in its revisions to
§ 52.79(a). Therefore, in the final rule,
the NRC has added requirements to
address the implementation of all
operational programs required to be
described in a COL application. This is
consistent with the Commission’s
direction to the staff in SRM–SECY–02–
0067 (September 11, 2002,
ML022540755) that a combined license
applicant was not required to have
ITAAC for operational programs if the
applicant fully described the
operational program and its
implementation in the combined license
application.
Question 8: Backfitting—reproduce
backfitting requirements in part 52. The
NRC notes that the backfitting
provisions applicable to various part 52
processes are contained in both part 50
and part 52 and, therefore, the proposed
language for § 50.109 cross-references to
applicable provisions of part 52, which
may be confusing. The NRC is
considering adopting in the final rule an
alternative which would remove from
§ 50.109 the backfitting provisions
applicable to the licensing and approval
processes in part 52, and place them in
part 52. There are two possible
approaches for doing so: the first would
be for the NRC to establish a general
backfitting provision in part 52
applicable exclusively to the licensing
and approval processes in part 52.
Under this approach, each licensing and
approval process in part 52 would be
the subject of a backfitting section in a
new subpart of part 52 (e.g., § 52.201 for
standard design approvals, etc.). The
existing backfitting provisions
applicable to early site permits and
design certification would be transferred
to the relevant sections in the new
subpart. The second approach would be
to ensure that each subpart of part 52
contains the backfitting provisions
applicable to the licensing or approval
process in that subpart. The NRC is
considering adopting these alternative
approaches in the final rule and
requests public comment on whether
either of these administrative
approaches is preferable to the approach
in the proposed rule.
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Commenters’ Response: Some
commenters stated that NRC’s
alternative approach to addressing
backfitting was unnecessary to clarify
the application of the backfit rule to part
52 actions. Commenters stated that the
proposed rule included adequate
references to § 50.109 and in the various
subparts of part 52, making replication
of this language elsewhere unnecessary.
If the NRC deemed the inclusion of such
information necessary, several
commenters suggested each subpart in
part 52 include its own standards for
backfitting to avoid confusion.
NRC Response: The NRC has decided
to revise § 50.109 to include the
conforming changes necessary to reflect
part 52, rather than adopting a
backfitting provision in part 52, because
no commenter favored the alternative
approach of adopting a backfitting
provision in part 52, and both
approaches are legally equivalent.
Question 9: The Commission is
considering adopting in the final part 52
rulemaking an alternative to the reproposed rule’s approach for addressing
new and significant environmental
information with respect to matters
addressed in the ESP environmental
impact statement (EIS) which require
supplementation.2 As a separate matter,
the Commission is also considering
adopting in the final part 52 rulemaking
an analogous requirement for addressing
new information necessary to update
and correct the emergency plan
approved by the ESP, the ITAAC
associated with EP, or the terms and
conditions of the ESP with respect to
emergency preparedness, or new
information materially changing the
Commission’s determinations on
emergency preparedness matters
previously resolved in the ESP. To
implement either or both of these
alternatives, the Commission is also
evaluating whether several additional
concepts should be adopted in the final
rulemaking. The two alternatives, as
well as the additional implementing
concepts, are described below. The
Commission emphasizes that it may,
with respect to the alternative
addressing updating environmental
information and emergency
preparedness information, adopt either
or both alternatives in the final part 52
2 The scope of environmental information that
must be supplemented is limited to the matters
which were addressed in the original EIS for the
ESP. Thus, for example, if the ESP applicant chose
not to address need for power (as is allowed under
§ 52.18), the combined license applicant need not
address need for power in its environmental report
(ER) to update the ESP EIS, and the NRC need not
determine whether there is new and significant
information with respect to need for power as part
of the updating of the ESP EIS.
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rulemaking, in place of or in addition to
the proposed rule’s alternative of
conducting the updating in each
combined license proceeding. Under the
option where multiple alternatives for
updating environmental and emergency
preparedness information would be
allowed, the Commission proposes that
the decision be left to the combined
license applicant as to which alternative
to pursue. Commenters are requested to
address: (1) the advantages and
disadvantages of adopting each
alternative for updating environmental
and emergency preparedness
information in an ESP proceeding as
opposed to the proposed rule’s
alternative of conducting the updating
in each combined license proceeding;
(2) whether the Commission should
only allow updating of environmental
and emergency preparedness
information in an ESP proceeding or in
a COL proceeding, but not both; and (3)
if the Commission allows updating in
either an ESP proceeding or in a COL
proceeding, whether it should be an
option for the COL applicant to decide
which update process to pursue. The
Commission believes it may allow COL
applicants the option of deciding
whether to update environmental and
emergency preparedness information in
either an ESP proceeding or in a COL
proceeding in order to afford the COL
applicant the determination which
approach best satisfies their business
and economic interests.
Environmental Matters Resolved in ESP
The Commission is considering
requiring a combined license applicant
planning to reference an ESP to submit
a supplemental environmental report for
the ESP. The supplemental
environmental report must address
whether there is any new and
significant environmental information
with respect to the environmental
matters addressed in the ESP EIS. Based
upon this information, the NRC will
prepare a draft supplemental
environmental assessment (EA) or EIS
setting forth the agency’s proposed
determinations with respect to any new
and significant information. In
accordance with existing practice and
procedure, the draft supplemental EA or
EIS will be issued for public comment.
After considering comments received
from the public and relevant Federal
and State agencies, the NRC will issue
a final supplemental EA or EIS. Once
the final supplemental EA or EIS is
issued, the ESP finality provisions in
proposed § 52.39 would apply to the
matters addressed in the supplemental
EA or EIS, and those matters need not
be addressed in any combined license
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proceeding referencing the ESP. Thus,
for example, if a new and significant
environmental issue, for example, a
newly-designated endangered species, is
addressed in the supplemental ESP EIS,
the matter would be resolved for all
combined licenses referencing the ESP
(unless, of course, there is new and
significant information identified at the
time of a subsequent referencing
combined license with respect to that
endangered species). There would be no
updating of environmental information
necessary in the combined license
proceeding. The Commission considers
this approach for updating the ESP as
meeting the Agency’s obligations under
the National Environmental Policy Act
(NEPA), without imposing undue
burden on the ESP holder and the NRC
through continuous or periodic
updating, and preserving the distinction
between the ESP and any referencing
combined license proceeding. Since an
ESP may be referenced more than once,
this approach would provide for issue
finality of the updated information and
preclude the need for reconsideration of
the same environmental issue in
successive combined license
proceedings referencing the ESP. The
Commission requests public comment
on this proposal, which would likely
involve changes to §§ 52.39, 51.50(c),
51.75, and 51.107 (and possibly
conforming changes in parts 2, 51, and
52).
Emergency Preparedness Information
Resolved in ESP
The Commission is separately
considering requiring a combined
license applicant referencing an ESP to
provide to the NRC new EP information
necessary to correct inaccurate
information in the ESP emergency plan,
EP ITAAC, or the terms and conditions
of the ESP with respect to EP. Based
upon the EP information submitted by
the combined license applicant, the
NRC will, as necessary, approve changes
to the ESP emergency plan, the EP
ITAAC, or the terms and conditions of
the ESP with respect to EP. Once the
Commission has resolved the EP
updating matters, these matters would
be accorded finality under § 52.39.
There would be no separate updating
necessary in the combined license
proceeding. Thus, for example, if an EP
ITAAC in an ESP were changed by
virtue of this updating process, the
changed ITAAC for EP would be
applicable to any combined license
referencing the ESP whose ITAAC have
not yet been satisfied (i.e., the amended
EP ITAAC would not be applicable to a
combined license where the
Commission has made the § 52.103(g)
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finding with respect to that EP ITAAC).
The NRC’s consideration of such EP
information would be considered to be
part of the ESP proceeding, and any
necessary changes with respect to EP
would therefore be deemed to be
changes within the scope of the ESP.
The Commission considers this
proposal as a means for updating the
ESP with respect to EP information in
a timely fashion, without imposing
undue burden on the ESP holder and
the NRC through continuous or periodic
updating, while preserving the
distinction between the ESP and any
referencing combined license
proceeding.
Since an ESP may be referenced more
than once, this approach would provide
for issue finality of the updated
information and preclude the need for
reconsideration of the same issue in
successive combined license
proceedings referencing the ESP. The
Commission requests comment whether
this approach should be adopted by the
Commission in the final rulemaking,
which will likely involve changes to
§ 52.39 (and possible conforming
changes in § 50.47, 50.54, and 10 CFR
part 50, appendix E).
ESP Updating in Advance of Combined
License Application Submission
To minimize the possibility that the
ESP updating process may adversely
affect a combined license proceeding
referencing that ESP, the Commission
proposes to require the combined
license applicant intending to reference
an ESP to submit its application to
update the ESP with respect to EP and/
or environmental information no later
than 18 months before the submission of
its combined license application. The
Commission believes that the 18-month
lead time is sufficient to complete the
NRC’s regulatory consideration of the
updating, such that the combined
license applicant will be able to prepare
its application to reflect the updated
ESP. The Commission also recognizes
that there may be increased regulatory
complexity under this approach, as well
as the possibility that resources may be
unnecessarily expended if the potential
combined license applicant ultimately
decides not to proceed with its
application. The Commission requests
public comment on whether the 18month lead time is appropriate, whether
the time should be decreased or
increased, or whether the Commission
should simply require that the ESP
update application be filed no later than
simultaneously with the filing of the
combined license application. Based
upon the public comments, the
Commission will adopt one of these
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alternatives, if it decides that updating
of environmental and/or EP matters
should be accomplished in an ESP
proceeding, as opposed to the combined
license proceeding in which the ESP is
referenced.
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Expanding the Scope of Resolved Issues
After ESP Issuance
The Commission is also considering
whether the final rule should include
provisions addressing how the ESP
holder may request, at any time after the
issuance of the ESP, that additional
issues be resolved and given finality
under § 52.39. For example, the holder
of the ESP which does not include an
approved emergency plan, may wish to
submit complete emergency plans for
NRC review and approval. Such a
request is not explicitly addressed in
either the current or re-proposed
subpart A to part 52, although it would
be reasonable to treat that request as an
application to amend the ESP.
The Commission requests public
comment on whether the Commission
should adopt in the final rule new
provisions in subpart A to part 52 that
would explicitly address requests by the
ESP holder to amend the early site
permit to expand the scope of issues
which are resolved and given issue
finality under § 52.39. The Commission
is also considering whether, as part of
the ESP updating process discussed
previously, the ESP holder/combined
license applicant should be allowed to
request an expansion of issues which
are resolved and given issue finality.
If the Commission were to allow an
ESP holder/combined license applicant
to expand the scope of resolved issues
in the ESP update proceeding, the
Commission believes that the 18-month
time period for filing the updating
application in the ESP proceeding may
be insufficient, and is considering
adopting in the final rule a 24-month (2year) period for filing the ESP updating
application, where the ESP holder/
combined license applicant seeks to
expand the scope of resolved issues.
The Commission seeks public comment
on whether, in such cases, the
Commission should require in the final
rule an 18- or 24-month period, or some
other period, for submitting its ESP
updating application.
Approval in ESP of Process and Criteria
for Updating ESP After Issuance
The Commission requests public
comment whether the Commission
should adopt in the final rulemaking
provisions affording the ESP applicant
the option of requesting NRC approval
of procedures and criteria for
identifying and assessing new and
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significant environmental information,
and/or new information necessary to
update and correct the emergency plan
approved by the ESP, the ITAAC
associated with emergency
preparedness (EP), or the terms and
conditions of the ESP with respect to
emergency preparedness, or otherwise
materially changing the Commission’s
determinations on emergency
preparedness matters previously
resolved in the ESP. These procedures
and criteria, if approved as part of the
ESP issuance, could be used by any
combined license applicant referencing
the ESP to identify the need to update
the ESP with respect to environmental
and/or emergency preparedness
information. There would be no need
for the NRC to review the adequacy of
the ESP holder/combined license
applicant’s process and criteria for
determining whether new information is
of such importance or significance so as
to require updating; the NRC review
could thereby be focused solely on
whether the ESP holder’s updated
information, or determination that there
is no change in either an environmental
or emergency preparedness matter, was
correct and adequate. Under this
proposal, § 52.17 and/or § 51.50(b)
would be amended to incorporate such
a process for ‘‘pre-approval’’ of ESP
updating procedures and criteria.
While NRC approval of updating
procedures and criteria would be
reflected in the ESP, the Commission
does not believe that the ESP itself must
contain the procedures and criteria in
order to be accorded finality under
§ 52.39. An ESP holder/combined
license applicant need not comply with
any or all of the updating process and
criteria, and would be free to use (and
justify) other procedures or criteria in
the ESP updating proceeding. Naturally,
there would be no finality associated
with such departures from the ESPapproved procedures and criteria.
The Commission does not believe that
either subpart A of part 52 or an ESP
with the contemplated approved
updating procedures and criteria should
contain a ‘‘change process’’ akin to
§ 50.59, allowing the ESP holder to
make changes to the approved updating
procedures and criteria without NRC
review and approval. Any change (other
than typographic and administrative
corrections) should require an
amendment to the ESP. However, the
Commission seeks public comment on
whether a different course should be
adopted in the final rule.
The Commission recognizes that any
NRC-approved procedures and criteria
for updating environmental and/or
emergency preparedness information in
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an ESP updating process as described
previously, would be equally valid for
updating such information under the
updating provisions in the re-proposed
rule. The Commission requests
comments on whether, if the
Commission adopts in the final
rulemaking the re-proposed rule’s
concept of updating in the combined
license proceeding, the Commission
should provide the ESP applicant with
the option of seeking NRC approval of
the procedures and criteria for updating
environmental and/or emergency
preparedness information in a combined
license proceeding which references the
ESP.
Public Participation in ESP Updating
Process
The Commission is considering two
ways for allowing public participation
in the updating process, if the updating
alternative is adopted in the final rule.
One approach would be to allow
interested persons to challenge the
proposed updating by submitting a
petition, analogous to that in proposed
§ 52.39(c)(2), which would be processed
in accordance with § 2.206. This
approach would be most consistent with
the existing provisions in § 52.39,
inasmuch as updating of an ESP is
roughly equivalent to a request that the
terms and conditions of an ESP be
modified. A consequence of this
approach is that the potential scope of
matters which may be raised is not
limited to those ESP matters which the
ESP holder/combined license applicant
and the NRC conclude must be updated.
The other approach that the
Commission may adopt is to treat any
necessary updating as an amendment to
the ESP, for which an opportunity to
request a hearing is provided. This
approach would limit the scope of the
hearing to those matters for which an
amendment is required. Where the ESP
holder does not request an amendment
on the basis that no updating is
necessary with respect to a matter, an
interested person could not intervene
with respect to that matter. A
consequence of this approach is that,
under the Commission’s regulations in
10 CFR part 2 and its current practice,
a hearing granted on any amendment
necessitated by the updating process
would be more formalized than a
hearing accorded under the § 2.206
petition process. The Commission
requests public comment on the
approach that the Commission should
adopt, together with the reasons for the
commenter’s recommendation.
Commenters’ Response: Several
commenters believed an ESP holder
should not be required to update the
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information in the ESP application.
These commenters stated that the
proposal to require updating would add
an unnecessary additional level of
review (and possibly hearings) with
little or no additional benefit (i.e., the
COL applicant would still be under the
obligation to update the information
provided by the ESP holder). Some
commenters contended that an updating
requirement would only serve to erode
the finality and certainty provided by
the ESP, thereby defeating one of the
purposes of an ESP. These commenters
also believed that an updated
requirement would run counter to NRC
regulations. Some commenters stated
that while the ESP is in effect, the NRC
cannot change or impose new
requirements, including emergency
planning requirements, unless it
determines that a modification is
necessary either to bring the permit or
the site into compliance with the NRC’s
regulations and orders applicable and in
effect at the time the permit was issued,
or to assure adequate protection of the
public health and safety or the common
defense and security. Some commenters
argued that the proposed 18-month
updating requirement may not be
feasible. A commenter gave the
following example, ‘‘under the NRC’s
current schedule for the existing ESP
applications for North Anna and Grand
Gulf, the ESPs will not be issued until
2007, shortly before the planned COL
applications for those sites. This would
result in insufficient time for the
updating envisioned by the NRC, and it
would be unfair to those applicants to
require them to delay their COL
applications to accommodate the
updating process. Additionally, the
proposed updating process would be
inconsistent with § 52.27(c), which
permits a COL application to reference
an ESP application.’’
Several commenters agreed with
NRC’s proposal to provide the ESP
holder with the option of requesting an
ESP amendment in order to resolve
issues that were not addressed at the
ESP stage or to achieve finality on
updated information. These commenters
also suggested that a COL applicant
should be able to reference an
application for an ESP amendment that
is pending approval by the NRC similar
to the process that already exists in 10
CFR 52.27(c).
Several commenters expressed the
belief that a COL applicant should be
able to make changes or updates to ESP
emergency planning information
without NRC approval in accordance
with the criteria in 10 CFR 50.54(q) just
as the remaining safety information can
be revised under § 50.59 once it has
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been reviewed and approved. These
commenters also stated that this revised
information should not be considered as
an ‘‘amendment’’ submitted under
§ 50.90 for review and approval, but
rather should be considered to be
information equivalent to that provided
under § 50.71(e) for information.
NRC Response: Upon consideration of
the public comments on this subject, the
NRC has decided not to require
updating of ESP information prior to
receipt of a COL application referencing
the ESP. The NRC is retaining the
proposed rule structure for dealing with
new EP and environmental information
at the COL stage. The NRC believes this
structure will provide for the most
effective and efficient use of NRC and
applicant resources. The NRC is,
however, making revisions to the final
rule to allow for voluntary changes to an
ESP by the ESP holder through the
license amendment process.
Specifically, the NRC is making
revisions to §§ 50.90 and 50.92 to
include ESPs within the scope of these
requirements. The NRC is also adding a
new provision to § 52.39 to allow ESP
holders to make changes to the ESP,
including changes to the SSAR, under
the license amendment process. These
changes will provide ESP holders with
additional flexibility to resolve issues
that were not addressed in the original
ESP review and to achieve finality on
new information. The NRC does not
believe it is necessary to add rule
language to address the situation where
a COL applicant references an ESP for
which there is an amendment review
pending before the NRC. The NRC will
address these situations on a case-bycase basis.
Question 10: The Commission is
considering adopting in the final part 52
rulemaking a new provision in § 50.71
that would require combined license
holders to update the PRA [probabilistic
risk assessment] submitted with the
combined license application
periodically throughout the life of the
facility on a schedule similar to the
schedule for final safety analysis report
(FSAR) updates (i.e., at least every 24
months) or, alternatively, on a schedule
to coincide with every other refueling
outage. Updates would be required to
ensure that the information included in
the PRA contains the latest information
developed. The PRA update submittal
would be required to contain all the
changes necessary to reflect information
and analyses submitted to the
Commission by the licensee or prepared
by the licensee pursuant to Commission
requirement since the submittal of the
original PRA, or as appropriate, the last
update to the PRA under this section.
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The submittal would be required to
include the effects of all changes made
in the facility or procedures as reflected
in the PRA; all safety analyses and
evaluations performed by the licensee
either in support of approved license
amendments or in support of
conclusions that changes did not require
a license amendment in accordance
with § 50.59(c)(2) or, in the case of a
license that references a certified design,
in accordance with § 52.98(c); and all
analyses of new safety issues performed
by or on behalf of the licensee at
Commission request. The Commission
requests stakeholder feedback on
whether such a requirement should be
added to the Commission’s regulations
and, if so, what is an appropriate update
schedule.
Commenters’ Response: Several
commenters noted that the proposed
rule did not include a frequency for
updating the PRA. These commenters
noted that the Commission stated that
PRA scope and methods should be
addressed in guidance, not in
regulations (SRM on SECY–05–0203).
These commenters stated that they
believed that PRA update frequency
should also be addressed in guidance
rather than regulations. These
commenters indicated a frequency of
once every two operating cycles would
be reasonable and consistent with
existing requirements in 10 CFR
50.69(e).
Additionally, some commenters
stated the plant-specific PRA used to
support a COL application that
references a design certification would
essentially be the design certification
PRA. These commenters expressed the
belief that the plant-specific PRA would
be updated to be consistent with the
PRA scope and quality standards 6
months before the COL was issued as
plant-specific design and as-built
information was developed during
construction. Some commenters argued
that this would allow (1) an updated
plant-specific PRA that was
representative of the as-built plant to be
completed, and (2) an updated plantspecific PRA that would be available
prior to fuel load for NRC audit and to
support plant operations. These
commenters suggested that the update
of the plant-specific PRA during
construction was a matter suitable for
guidance.
Some commenters expressed
confusion over the NRC proposal to
require PRA updates to reflect safety
analyses and evaluations performed by
the licensee, and analyses of new safety
issues performed by or on behalf of the
licensee at the NRC’s request. These
commenters stated that new analyses
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and evaluations were often performed
using design-basis assumptions that
may not be appropriate for a PRA. These
commenters suggested that only new
analyses that impact the PRA warrant
consideration, and requested guidance
and examples be developed regarding
the information that should be
considered when updating the plantspecific PRA.
NRC Response: As discussed in
further detail in Section V.D.6.b of this
document, the Commission is adopting
requirements to require maintenance of
a PRA, and periodic upgrades every 4
years, by a COL holder beginning at the
time of initial operation. These PRAs
and upgrades are not required to be
submitted to the NRC, but instead
should be maintained by the licensee for
NRC inspection.
Question 11: In a letter dated July 5,
2005, the Nuclear Energy Institute (NEI)
submitted comments on the proposed
rule for the AP1000 design certification.
Many of those comments have generic
applicability to the three pre-existing
design certification rules (DCRs) in
appendices A through C of 10 CFR part
52. In the final AP1000 rulemaking
(January 27, 2006; 71 FR 4464), the
Commission adopted some of the NEIrecommended changes, while rejecting
others (71 FR 4465–4468). For those
changes that were adopted in the final
AP1000 design certification, the
Commission indicated that it would
consider making the same changes to
the existing design certifications in
appendices A through C. For those
changes that were not adopted in the
final AP1000 design certification, the
Commission stated that it would
reconsider the issues in the part 52
rulemaking, and if the Commission
changes its position and the change is
adopted, the Commission would make
the change for all four design
certifications, including the AP1000.
The Commission is considering
amending the appropriate sections in
each DCR based on the comments
below. The Commission considers most
of NEI’s proposed changes to be
consistent with proposed § 52.63(a)(1);
in particular, the Commission believes
that the proposed changes would satisfy
the ‘‘reduces unnecessary regulatory
burden’’ criterion in proposed
§ 52.63(a)(1)(iii). The few remaining
changes, constituting editorial
clarifications or corrections reflecting
the Commission’s original intent, are
not subject to the existing change
restrictions in § 52.63(a)(1).
Accordingly, the Commission believes
that it has authority to incorporate some
or all of the NEI-proposed changes into
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appendices A through D in the final part
52 rulemaking.
The Commission also requests
comments on whether some of NEI’s
proposed changes accepted in the
AP1000 design certification and
proposed for inclusion in appendices A
through C should not be included in
those appendices in the final part 52
rulemaking because they are
unnecessary, or because they would not
meet one or more of the change criteria
in proposed § 52.63(a)(1). The
Commission is also assessing whether
NEI’s proposed changes which were not
adopted in the AP1000 final rulemaking
should be adopted in the final part 52
rulemaking for all four design
certifications, including the AP1000.
The Commission is particularly
interested in whether there are reasons,
other than those presented by NEI, for
adopting those changes, as well as
commenter’s views on the
Commission’s reasons for rejecting the
NEI proposals as stated in the final
AP1000 design certification rulemaking.
a. NEI recommended modification of
the generic technical specification
definition in Section II.B to clarify that
bracketed information is not part the
DCRs for purposes of the change
processes in Section VIII.C, and an
exemption is not required for plantspecific departures from bracketed
information. The Commission stated in
the section-by-section analysis for the
AP1000 DCR (71 FR 4464) that some
generic technical specifications and
investment protection short-term
availability controls contain values in
brackets. The values in brackets are
neither part of the DCR nor are they
binding. Therefore, the replacement of
bracketed values with final plantspecific values does not require an
exemption from the generic technical
specifications or investment protection
short-term availability controls. The
Commission believes that including this
guidance in each DCR is not necessary.
The Commission requests comment on
whether there are countervailing
considerations that favor inclusion of
this provision in the DCRs.
b. NEI recommended modification of
the Tier 2 definition in Section II.E to
clarify that bracketed information in the
investment protection short-term
availability controls is not part of Tier
2 and thus not subject to the Section
VIII.B change controls. The Commission
stated in the section-by-section analysis
for the AP1000 DCR (71 FR 4464) that
some generic technical specifications
and investment protection short-term
availability controls contain values in
brackets. The values in brackets are
neither part of the DCR nor are they
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binding. Therefore, the replacement of
bracketed values with final plantspecific values does not require an
exemption from the generic technical
specifications or investment protection
short-term availability controls. The
Commission believes that including this
guidance in each DCR is not necessary.
The Commission requests comment on
whether there are countervailing
considerations that favor inclusion of
this provision in the DCRs.
c. NEI recommended modification of
the requirement in Section VIII.C.2 to
delete the phrase ‘‘or licensee’’ because
that phrase conflicted with the
requirement in Section VIII.C.6. The
Commission believes that generic
technical specifications should not
apply to holders of a combined license
because the license will include plantspecific technical specifications.
Therefore, the Commission is
considering amending each of the DCRs
to delete the phrase ‘‘or licensee’’ from
Section VIII.C.2 and requests public
comment on this approach.
d. NEI recommended modification of
the requirement in Section VIII.C.6 to
delete the last portion, which states
‘‘changes to the plant-specific technical
specifications will be treated as license
amendments under 10 CFR 50.90.’’ NEI
stated that this sentence is not necessary
because it is redundant with § 50.90. It
is not necessary to include a provision
in each DCR stating that a license
amendment is necessary to make
changes to technical specifications in
order to render this a legally-binding
requirement inasmuch as Section 182.a
of the AEA requires that technical
specifications be part of each license.
The Commission believes that clarity
and understanding by the reader is
enhanced by repeating this statutory
requirement in each DCR. The
Commission requests comment on
whether there are countervailing
considerations that favor non-inclusion
of this provision in the DCRs, and may
decide to remove this provision in the
final part 52 rulemaking.
e. NEI recommended modification of
the requirement in Section X.A.1 to
require the design certification
applicant to include all generic changes
to the generic technical specifications
and other operational requirements in
the generic DCD. The Commission
believes that inclusion of changes to the
generic technical specifications and
other operational requirements will
enhance the generic DCD and facilitate
its use by referencing applicants. The
Commission is considering amending
each of the DCRs to include the generic
technical specifications and other
operational requirements in the generic
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DCD and requests public comment on
this approach.
f. NEI recommended modification of
the requirement in Sections IV.A.2 and
IV.A.3 to be consistent with respect to
inclusion of information in the plantspecific DCD, or explain the difference
between ‘‘include’’ (IV.A.2) and
‘‘physically include’’ (IV.A.3). The
Commission is considering amending
each of the DCRs to use the same term
in both provisions, and requests public
comment on this approach.
g. NEI recommended modification of
the definition in Section II.E.1 to
exclude the design-specific probabilistic
risk assessment (PRA) and the
evaluation of the severe accident
mitigation design alternatives (SAMDA)
from Tier 2 information. The
Commission believes that the PRA and
SAMDA evaluations do not need to be
included in Tier 2 information because
they are not part of the design basis
information. The Commission is
considering amending each of the DCRs
to modify the definition of Tier 2, and
requests public comment on this
approach.
h. NEI recommended modification of
the requirement in Section III.E to use
‘‘site characteristics’’ consistently,
instead of ‘‘site-specific design
parameters.’’ The Commission intends
to use the term ‘‘characteristics’’ to refer
to actual values and ‘‘parameters’’ to
refer to postulated values. The
Commission has proposed amending
Section III.E of each DCR to use ‘‘site
characteristics,’’ and requests public
comment on this approach.
i. NEI recommended modification of
Section IV.A.2 to clarify the use of
‘‘same information’’ and ‘‘generic DCD’’
in that requirement. The Commission
has proposed amending Section IV.A.2
of each DCR to use the phrase ‘‘same
type of information’’ to avoid confusion,
and requests public comment on this
approach.
j. NEI recommended modification of
the requirement in Section VIII.B.6.a to
delete the sentence ‘‘The departure will
not be considered a resolved issue,
within the meaning of Section VI of this
appendix and 10 CFR 52.63(a)(4),’’ in
order to be consistent with the
requirement in Section VI.B.5 of the
DCRs. The Commission believes that
departures from Tier 2* information
should not receive finality or be treated
as resolved issues within the meaning of
section VI.B of the DCRs. The
Commission requests comment on
whether departures from Tier 2*
information should be considered a
resolved issue, and may decide to
remove this provision from each DCR.
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k. NEI recommended modification of
Section VIII.C.3 to require the NRC to
meet the backfit requirements of 10 CFR
50.109 in addition to the special
circumstances in 10 CFR 2.758(b)
(which has now been designated as
§ 2.335) in order to require plantspecific departures from operational
requirements. The Commission believes
that plant-specific departures should
not have to meet the backfit requirement
for generic changes. The Commission
will have to demonstrate that special
circumstances, as defined in § 2.335, are
present in order to require a plantspecific departure. The Commission
requests comment on whether there are
countervailing considerations that
would favor modification of this
provision in the DCRs.
l. NEI recommended modification of
the requirement in Section VIII.C.4 to
include a requirement that operational
requirements that were not completely
reviewed and approved by the NRC
should not be subject to any Tier 2
change controls, e.g., exemptions.
However, NEI previously proposed that
requested departures from Chapter 16
by an applicant for a COL require an
exemption (62 FR 25808; May 12, 1997).
The Commission believes that the
requirement for an exemption applies to
technical specifications and operational
requirements that were completely
reviewed and approved in the design
certification rulemaking (see 62 FR
25825). The Commission requests
comment on whether departures from
technical specifications and operational
requirements that were not completely
reviewed and approved should also
require an exemption.
m. NEI recommended modification of
the requirement in Section VIII.C.4 to
delete the sentence ‘‘The grant of an
exemption must be subject to litigation
in the same manner as other issues
material to the license hearing,’’ in order
to be consistent with the requirement in
Section VI.B.5 of the DCRs. The
Commission believes that exemptions
from operational requirements should
not receive finality or be treated as
resolved issues (refer to Section VI.C of
the DCRs). The Commission requests
comment on whether exemptions from
operational requirements should be
considered a resolved issue, and may
decide to modify this provision in each
DCR.
n. NEI recommended modification of
the requirement in Section IX.B.1 to
better distinguish between NRC staff
ITAAC conclusions under proposed
§ 52.99(e) and the Commission’s ITAAC
finding under proposed § 52.103(g). The
Commission believes that individual
DCRs should not address the scope of
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the NRC staff’s activities with respect to
ITAAC verification. This is a generic
matter that, if it is to be addressed in a
rulemaking, is more appropriate for
inclusion in subpart C of part 52 dealing
with combined licenses. The
Commission requests comment on
whether there are countervailing
considerations that favor clarification of
this provision in the DCRs.
o. NEI recommended modification of
the language in Section IX.B.3 to make
editorial changes for clarity, e.g.,
‘‘ITAAC will expire’’ vs. ‘‘their
expiration will occur.’’ The Commission
believes that the original rule language
is acceptable. The Commission requests
comment on whether there are
countervailing considerations that favor
clarification of this provision in the
DCRs.
p. NEI recommended modification of
the language in Sections X.B.1 and
X.B.3 to clarify references to the design
control documents, e.g., ‘‘plant-specific’’
vs. ‘‘generic.’’ The Commission agrees
that the references to plant-specific and
generic DCD should be clarified in
Sections X.B.1 and X.B.3 to ensure that
the requirements in these sections are
properly implemented by applicants
referencing the design certification
rules. The Commission requests public
comment on this prospective
modification.
Commenters’ Response: Several
commenters recommended the NRC
incorporate the NEI recommendations
on the AP1000 rule, cited specific NEI
recommendations (71 FR 12834–12836),
and made additional suggestions and
clarifications.
Regarding NEI recommendations (a)
and (b), several commenters suggested it
would be sufficient if the statements of
considerations for the final rule
provided the requested clarification,
rather than the rule itself.
Regarding NEI recommendation (f),
several commenters supported the use
of the term ‘‘include’’ rather than
‘‘physically include’’ for requirements
in Section IV of the design certification
rules concerning content of COLAs.
These commenters also requested
clarification on the permissible method
of incorporating the generic DCD into
the plant-specific DCD portion of the
COL application’s final safety analysis
report (FSAR), because the current NRC
position has apparently ‘‘led to
considerable confusion’’ among COL
preparers. These commenters noted that
in the statements of consideration
accompanying the AP1000 final rule,
NEI recommended a change to the
Definitions (Section III.B of that rule, 71
FR 4466). These commenters stated the
NRC staff disagreed with this
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recommendation, saying that ‘‘the
generic DCD should also be part of the
FSAR, not just incorporated by
reference, in order to facilitate the NRC
staff’s review of any departures or
exemptions.’’ Some commenters
believed that this NRC position was in
conflict with the former § 52.79(b),
which states that the COL application’s
FSAR ‘‘may incorporate by reference the
final safety analysis report for a certified
standard design,’’ and with § 50.32,
which provides for incorporation by
reference to eliminate repetitive
information. Some commenters argued
that although the wording had been
altered, the ability to incorporate by
reference was preserved in proposed
§§ 52.79 (b) and (c), respectively. These
commenters claimed this interpretation
of incorporation was validated by NRC
staff during the Draft Regulatory Guide
(DG)–1145 workshops. These
commenters stated support for this
interpretation and requested the NRC
explicitly describe that either approach
is acceptable.
In discussing NEI recommendation (j),
several commenters mentioned Section
VIII.B.6.a of the design certification
rules, which states that an applicant
who references the design certification
rule must obtain NRC approval for
departures from Tier 2* information in
the generic DCD. Some commenters
believed that this section states the
departure is not considered to be a
resolved issue under Section VI of the
design certification rules. Some
commenters indicated this was
inconsistent with Section VI.B.5 of the
design certification rules, which states
that license amendments are considered
to be resolved. These commenters
expressed support for the revision of
Section VIII.B.6. of the design
certification rules to make it consistent
with Section VIII.B.5 of the design
certification rules. These commenters
stated that departures from Tier 2*
information that are reviewed and
approved by the NRC in the combined
license proceeding should have finality
for the plant in question.
With respect to NEI recommendation
(k), several commenters expressed
concern that Section VIII.C.3 of the
design certification rules
‘‘inappropriately’’ allowed the NRC to
make changes to operational
requirements in the DCD without
satisfying the backfit requirements in
§ 50.109. These commenters stated that
the operational requirements in the
design certification proceeding should
be afforded the protection of the backfit
rule. Some commenters supported a
revision to Section VIII.C.3 of the design
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certification rules to include a reference
to § 50.109 for these changes.
In the discussion of NEI
recommendations (l) and (m), several
commenters mentioned Section VIII.C.4
of the design certification rules, which
states a COL applicant must request an
exemption from the NRC if the
applicant wants to depart from the
generic technical specifications or other
operational requirements. These
commenters described this requirement
as ‘‘unduly burdensome.’’ These
commenters noted that the operational
requirements do not have finality under
Section VI.C of the design certification
rules, and that no basis existed for
applying such a change control process
to a COL applicant seeking to change
operational requirements. Some
commenters cited Section VIII.B.5 of the
design certification rules, which states a
COL applicant may depart from final
design-related provisions in the design
certification rule using a ‘‘§ 50.59-like’’
process, and argued that imposing an
exemption process with respect to
operational provisions was not required.
Some commenters recommended
Section VII.C.4 be amended to state that
a departure from an operational
requirement does not require an
exemption.
Several commenters mentioned
information from NEI’s September 30,
2003, response to the 2003 part 52
notice of proposed rulemaking. These
commenters expressed support for the
need to add a basic definition of
‘‘departure’’ to the DCRs to be consistent
with adding the definition of ‘‘departure
from a method of evaluation,’’ and
stated that both should be based on
Regulatory Guide 1.187. The
commenters stated, ‘‘The basic
definition of ‘change or departure’
should precede the definition of
departure from a method of evaluation.’’
Some commenters recommend adding
the new definition as paragraph II.G and
renaming the final two paragraphs as
II.H and II.I.
NRC Response: In response to
Question 11.a, the NRC has decided that
modification of the generic technical
specification definition in Section II.B
of the DCRs is not necessary. As stated
in the section-by-section analysis for the
AP1000 DCR (71 FR 4475; January 27,
2006):
Some generic technical specifications and
investment protection short-term availability
controls contain values in brackets [ ]. The
brackets are placeholders indicating that the
NRC’s review is not complete, and represent
a requirement that the applicant for a
combined license referencing the AP1000
DCR must replace the values in brackets with
final plant-specific values. The values in
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brackets are neither part of the design
certification rule nor are they binding.
Therefore, the replacement of bracketed
values with final plant-specific values does
not require an exemption from the generic
technical specifications or investment
protection short-term availability controls.
The NRC believes that the above
guidance resolves NEI’s concern
regarding bracketed information in the
generic technical specifications.
Regarding Question 11.b, the NRC has
decided that modification of the Tier 2
definition in Section II.E of the DCRs is
not necessary. The NRC believes that
the previously mentioned guidance
resolves NEI’s concern regarding
bracketed information in the investment
protection short-term availability
controls located in the Tier 2
information.
Regarding Question 11.c, the NRC
agrees with NEI’s recommendation and
has decided to delete the phrase ‘‘or
licensee’’ from Section VIII.C.2 of the
DCRs because the generic technical
specifications will not apply to holders
of a combined license.
Regarding Question 11.d, the NRC has
decided not to modify the rule language
in Section VIII.C.6 of the DCRs, which
states that ‘‘changes to the plant-specific
technical specifications will be treated
as license amendments under 10 CFR
50.90.’’ The Commission believes that
this statement provides clarity to this
requirement.
Regarding Question 11.e, the NRC
agrees with NEI’s recommendation and
has decided to modify the requirement
in Section X.A.1 of the DCRs. The
Commission believes that the inclusion
of changes to the generic technical
specifications and other operational
requirements in the generic design
control document (DCD) will enhance
the DCD and facilitate its use by
referencing applicants.
Regarding Question 11.f, the NRC has
decided to modify Section IV of the
DCRs to consistently use the term
‘‘include’’ rather than ‘‘physically
include’’ as recommended by NEI.
Several commenters also requested
clarification on the permissible method
of incorporating the generic DCD in the
plant-specific DCD portion of the COL
application’s final safety analysis report
(FSAR), because the NRC position has
apparently ‘‘led to considerable
confusion’’ among COL preparers. The
NRC is requiring COL applicants that
reference the DCRs in appendices A
through D of part 52 to include the
generic DCD in the application’s FSAR,
in order to facilitate the NRC staff’s
review of any departures or exemptions.
Simply incorporating the generic DCD
by reference into the FSAR is not
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sufficient because of the manner in
which these existing DCDs were
submitted to the NRC. Therefore,
Section IV.A.2 of the DCRs overrides
§§ 50.32 and 52.79(d). The NRC is
hopeful that future DCRs will not have
to use this special requirement.
Regarding Question 11.g, the NRC
agrees with NEI’s recommendation and
has decided to modify the definition of
Tier 2 in Section II.E.1 of the DCRs to
exclude the design-specific probabilistic
risk assessment (PRA) and the
evaluation of the severe accident
mitigation design alternatives
(SAMDAs). The NRC believes that the
PRA and SAMDA evaluations do not
need to be included in Tier 2 because
they are not part of the design basis
information. Also, the revised Section
II.E.1 is now consistent with the
requirements in the new § 52.80
regarding PRA and SAMDA evaluations.
Regarding Question 11.h, the NRC
agrees with NEI’s recommendation to
use ‘‘site characteristics’’ instead of
‘‘site-specific design parameters’’ in
Section III.E of the DCRs. This
modification of the rule language in
Section III.E was made in the proposed
rule and, therefore, no change was made
to the final rule.
Regarding Question 11.i, the NRC
agrees with NEI’s recommendation to
clarify the rule language in Section
IV.A.2.a of the DCRs and adopts the
phrase ‘‘same type of information’’ to
avoid confusion. An applicant for a
combined license must submit, as part
of its application, a plant-specific DCD
that contains the same type of
information and uses the same
organization and numbering as the
generic DCD. This organization will
facilitate the NRC staff’s review of the
plant-specific DCD. The NRC recognizes
that the plant-specific DCD will not
contain the exact, same information as
the generic DCD because the plantspecific DCD will be modified and
supplemented by the applicant’s
exemptions, departures, and COL action
items.
Regarding Question 11.j, the NRC
does not agree with NEI’s request to
modify the requirement in Section
VIII.B.6.a of the DCRs. The Commission
decided during the initial design
certification rulemakings that
departures from Tier 2* information (by
an applicant) would not receive finality
or be treated as a resolved issue within
the meaning of Section VI of the DCR.
This provision applies to applicants for
a combined license and the new
information is subject to litigation in the
same manner as other plant-specific
issues in the licensing hearing. Also,
Tier 2* information has the same safety
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significance as Tier 1 information and
would have received the Tier 1
designation, except that NRC decided to
provide more flexibility for this type of
information.
Regarding Question 11.k, the NRC
does not agree with NEI’s
recommendation to modify Section
VIII.C.3 of the DCRs. NEI requests that
the NRC meet the backfit requirements
in § 50.109 in addition to the special
circumstances in § 2.335 in order to
require plant-specific departures from
operational requirements. In the original
design certification rulemakings, the
Commission decided on different
standards for changes made under
Section VIII.C (see Section VI.C and 62
FR 25805; May 12, 1997). The
Commission has decided that plantspecific departures should not have to
meet the backfit requirements in
§ 50.109.
Regarding Question 11.l, the NRC
does not agree with NEI’s
recommendation to modify Section
VIII.C.4 of the DCRs. The requirement in
Section VIII.C.4 for an applicant to
request an exemption applies to generic
technical specifications and operational
requirements that were
comprehensively reviewed and
finalized in the design certification
rulemaking (see 62 FR 25825; May 12,
1997). Because this guidance is already
set forth in the section-by-section
discussion for the DCRs, the NRC has
decided that changes to the rule
language are not necessary.
Regarding Question 11.m, the NRC
does not agree with NEI’s
recommendation to delete the last
sentence from Section VIII.C.4 of the
DCRs. This sentence applies to
applicants for a combined license and
the new information is subject to
litigation in the same manner as other
plant-specific issues in the licensing
hearing. The Commission believes that
exemptions from operational
requirements should not receive finality
or be treated as resolved issues (refer to
Section VI.C of the DCRs).
Regarding Question 11.n, the NRC
does not agree with NEI’s
recommendation to modify Section
IX.B.1 of the DCRs. The NRC has
decided that individual DCRs should
not address the scope of the NRC staff’s
activities with respect to ITAAC
verification. This is a generic matter that
was addressed in § 52.99(e).
Regarding Question 11.o, the NRC
does not agree with NEI’s request to
clarify the phrase ‘‘their expiration will
occur’’ in Section IX.B.3 of the DCRs.
The NRC has decided that the original
rule language is acceptable.
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Regarding Question 11.p, the NRC
agrees with NEI’s recommendation to
clarify references to the DCDs in
Sections X.B.1 and X.B.3 of the DCRs.
The references to plant-specific and
generic DCD were revised in Sections
X.B.1 and X.B.3 to ensure that the
requirements in these sections will be
properly implemented by applicants
and licensees that reference the design
certification rules.
Question 12: The Commission is
considering adopting in the final part 52
rulemaking a new provision that would
either require combined license
applicants to submit a detailed schedule
for the licensee’s completion of ITAAC
or require the combined license holder
to submit the schedule for ITAAC
completion. Delaying submission of the
schedule would allow the combined
license holder to develop the schedules
based on more accurate information
regarding construction schedules and
would allow the schedule to be
submitted at a time when it would be
most useful to the NRC for planning
purposes. The Commission could
require that applicants submit the
schedule within a specified time prior
to scheduled COL issuance—for
example, 3 months prior to COL
issuance or within some time period
(e.g., 6 months or 1 year) after COL
issuance. In addition, the Commission is
considering an additional element to
this provision that would require that
the licensee submit an update to the
ITAAC schedule within 12 months after
combined license issuance and that the
licensee update the schedule every 6
months until 12 months before
scheduled fuel load, and monthly
thereafter until all ITAAC are complete.
The Commission is considering
adopting these requirements to support
the NRC staff’s inspection and oversight
with respect to ITAAC completion, and
to facilitate publication of the Federal
Register notices of successful
completion of ITAAC as required by
proposed § 52.99(e). The Commission
requests stakeholder comment on
whether such a provision, with or
without the update element, should be
added to the Commission’s regulations
and which time frame for submission of
the schedule would be most beneficial.
The Commission is also considering
adopting a provision that would
establish a specific time by which the
licensee must complete all ITAAC to
allow sufficient time for the NRC staff
to verify successful completion of
ITAAC, without adversely affecting the
licensee’s scheduled date for fuel load
and operation. The Commission
considers ‘‘60 days prior to the schedule
date for initial loading of fuel’’ to be a
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reasonable time period by which all
ITAAC must be completed. However,
the Commission requests comments on
whether this time period would provide
too much or too little time prior to
scheduled fuel load. Alternatively, the
Commission is considering a 30-day or
a 90-day time period prior to scheduled
fuel load. The 30-day option would
allow more flexibility for the licensee to
complete ITAAC late in construction
but would require immediate action on
the part of the NRC (to determine if the
final ITAAC were completed
successfully and, if so, for the
Commission to make its finding under
§ 52.103(g)) so as not to delay scheduled
fuel load. The 90-day option would
reduce licensee flexibility to complete
ITAAC late in construction but would
ensure that the NRC had ample time to
make its determination on the final
ITAAC for Commission review of all
ITAAC under § 52.103(g). The
Commission requests stakeholder
comment on whether a provision
requiring completion of ITAAC within a
certain time period prior to scheduled
fuel load should be added to the
Commission’s regulations.
Commenters’ Response: Several
commenters believed it was
unnecessary to include a requirement
for either the COL applicant or the COL
holder to submit a detailed schedule for
ITAAC completion because a COL
applicant could provide only a
progressively less accurate estimated
completion schedule. Some commenters
stated that the COL holder would have
schedules at the site, and those
schedules would be available for NRC
review. Some commenters believed that
COL holders would interact and
coordinate with the NRC to ensure that
NRC had sufficient information to
schedule its inspection activities for
ITAAC, making a regulatory
requirement for submission of a
schedule unnecessary. In addition, these
commenters noted that a COL applicant/
holder would likely consider detailed
schedule information to be proprietary
information, which would make its
submission inappropriate.
Several commenters also stated it was
‘‘wrong’’ to require completion of
ITAAC in a set time period prior to fuel
loading and operation. These
commenters indicated that a COL holder
would likely complete several ITAAC
within 30 days of fuel loading and
argued that the NRC should not abrogate
responsibility by imposing a mandatory
delay on licensees. Some commenters
stated the importance of the NRC
providing the appropriate level of
inspections and reviews to prevent
delays in fuel load and emphasized the
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high cost (stated to be on the order of
$1,000,000 per day) of such delay. Some
commenters suggested the NRC should
be in a position to make a § 52.103(g)
finding promptly following the
completion of the last ITAAC.
NRC Response: The NRC has decided
to amend § 52.99 to require licensees to
submit their schedules for completing
the inspections, tests, or analyses in the
ITAAC. The NRC has added a new
paragraph (a) in § 52.99 that requires a
licensee to submit to the NRC, no later
than 1 year after issuance of the
combined license or at the start of
construction as defined in 10 CFR 50.10,
whichever is later, its schedule for
completing the inspections, tests, or
analyses in the ITAAC. Licensees are
required 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 § 52.99(c)(1). Although
commenters did not believe that a
requirement for submission of a
schedule was necessary, the NRC
believes it is necessary to ensure that
the NRC has sufficient information to
plan all of the activities necessary for
the NRC to support the Commission’s
determination as to whether all of the
ITAAC have been met prior to initial
operation. In the event that licensees
consider their schedule information to
be proprietary, they can request that the
schedule be withheld from public
disclosure under § 2.390. If an applicant
claims that its construction schedule
information submitted to the NRC is
proprietary, and requests the NRC to
withhold that information under the
Freedom of Information Act (FOIA), the
NRC will consider that request under
the existing rules governing FOIA
disclosure in 10 CFR 2.309(a)(4).
The NRC has also decided to amend
§ 52.99(c) which requires the licensee to
notify the NRC that the prescribed
inspections, tests, and analyses in the
ITAAC have been or will be completed
and that the acceptance criteria have
been met. The NRC is revising
§ 52.99(c)(1) in the final rule to more
closely follow the language of Section
185b. of the AEA and to clarify that the
notification must contain sufficient
information to demonstrate that the
prescribed inspections, tests, and
analyses have been performed and that
the prescribed acceptance criteria have
been met. The NRC is adding this
clarification to ensure that combined
license applicants and holders are aware
that (1) it is the licensee’s burden to
demonstrate compliance with the
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ITAAC and (2) the NRC expects the
notification of ITAAC completion to
contain more information than just a
simple statement that the licensee
believes the ITAAC has been completed
and the acceptance criteria met. The
NRC expects 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 have been 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 have been
performed and that the prescribed
acceptance criteria have been met. The
NRC plans to prepare regulatory
guidance, in consultation with
interested stakeholders, to explain how
the functional requirement to provide
‘‘sufficient information’’ with regard to
ITAAC submittals could be met.
The NRC is also revising § 52.99(c) by
adding a new paragraph (c)(2) requiring
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 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. It is the licensee’s
burden to demonstrate that it will
comply with the ITAAC and it 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. 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 have been met.
Paragraph (e) has been revised to
require that the NRC make available to
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the public the notifications to be
submitted under § 52.99(c)(1) and (c)(2),
no later than the Federal Register notice
of intended operation and opportunity
for hearing on ITAAC under § 52.103(a).
A conforming change is included in
§ 2.105(b)(3) to require that the
§ 52.103(a) notice reference the public
availability of the § 52.99(c)(1) and (2)
notifications. The NRC is requiring that
the paragraph (c)(2) notification be
made 225 days before the date
scheduled for initial loading of fuel, in
order to ensure that the licensee
notifications are publicly available
through the NRC document room and
online through the NRC Web site at the
same time that the § 52.103(a) notice is
published in the Federal Register. The
NRC’s goal is to publish that notice 210
days before the date scheduled for fuel
loading, but in all cases the § 52.103(a)
notice would be published no later than
180 days before the scheduled fuel load,
as required by Section 189.a(1)(B) of the
AEA.
Commenters did not support addition
of a requirement on completion of
ITAAC in a set time period prior to fuel
load and the NRC has not included a
provision requiring the completion of
all ITAAC by a certain time prior to the
licensee’s scheduled fuel load date.
Instead, the NRC has decided to modify
the concept slightly by requiring the
licensee to submit, with respect to
ITAAC which have not yet been
completed 225 days before the
scheduled date for initial loading of
fuel, additional information addressing
whether those inspections, tests, and
analyses will be successfully completed
and the acceptance criteria met before
initial operation. In the case where the
licensee has not completed all ITAAC
by 225 days prior to its scheduled fuel
load date, the NRC expects the
information that the licensee submits
related to uncompleted ITAAC to be
sufficiently detailed such that the NRC
can determine what activities it will
need to undertake to determine if the
acceptance criteria for each of the
uncompleted ITAAC have been met,
once the licensee notifies the NRC that
those ITAAC have been successfully
completed and their acceptance criteria
met. In addition, the NRC is adopting
the requirements in paragraphs (c)(1)
and (c)(2) to ensure that interested
persons will have sufficient information
to address the Atomic Energy Act,
Section 189.a(1), threshold for
requesting a hearing with respect to
both completed and as-yet uncompleted
ITAAC. The NRC plans to prepare
regulatory guidance providing further
explanation of what constitutes
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‘‘sufficient information’’ that must be
submitted under paragraphs (c)(1) and
(c)(2) demonstrating that the
inspections, tests, or analyses for ITAAC
have been or will be completed and the
acceptance criteria for the ITAAC have
been or will be met. The NRC expects
that any contentions submitted by
prospective parties regarding
uncompleted ITAAC would focus on
any inadequacies of the specific
procedures and analytical methods
described by the licensee under
paragraph (c)(2), in the context of the
findings called for by § 52.103(b)(2).3
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 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 § 52.103(g).
Therefore, licensees should structure
their construction schedules to take into
account these time periods. The NRC
staff intends to develop regulatory
guidance on the licensee’s completion
and NRC verification of ITAAC and will
provide estimates of the time it expects
to take to verify successful completion
of various types of ITAAC. The NRC
expects that such guidance, along with
frequent communication with licensees
during construction, will provide
licensees with adequate information to
plan initial fuel loading and related
activities.
Question 13: ML Hearings. As
discussed in Section IV.F.6 of the March
13, 2006, proposed rule, the
Commission proposes, as a matter of
policy and discretion, that the
Commission hold a ‘‘mandatory’’
hearing (i.e., a hearing which, under
NRC requirements in 10 CFR part 2, is
held regardless of whether the NRC
receives any hearing requests or
petitions to intervene) in connection
with the initial issuance of every
manufacturing license. The Commission
believes that Section 189.a.(1)(A) of the
AEA does not require that a hearing be
held in connection with the initial
issuance of a manufacturing license.
3 Inasmuch as the ITAAC themselves have
already been approved by the NRC and their
adequacy may not be challenged except under the
provisions of § 52.103(f), a contention which alleges
the deficiency of the ITAAC is not admissible under
§ 52.103(b).
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Nonetheless, there are several reasons
for the Commission to require by rule,
as a matter of discretion, a mandatory
hearing. A manufacturing license may
be viewed as analogous to a
construction permit—a regulatory
approval for which Section 189 of the
AEA specifically requires that a hearing
be held. Even though the Commission’s
regulations did not address the hearing
requirements for manufacturing
licenses, the Commission noticed a
‘‘mandatory’’ hearing in connection
with the only manufacturing license
application ever received by the
Agency. Offshore Power Systems
(Floating Nuclear Power Plants), 38 FR
34008 (December 10, 1973).
Accordingly, proposed §§ 2.104 and
52.163 require that a mandatory hearing
be held in each proceeding for initial
issuance of a manufacturing license.
However, the Commission recognizes
that there may be countervailing
considerations weighing against
Commission adoption of a rulemaking
provision mandating that a hearing be
held in connection with the initial
issuance of every manufacturing license
where there has been no stakeholder
interest in a hearing. If there is no
stakeholder interest in a hearing,
transparency and public confidence
would not appear to be relevant
considerations in favor of holding a
mandatory hearing. Considerations of
regulatory efficiency and effectiveness
would be paramount, and would weigh
against holding of a mandatory hearing.
The Commission requests comments on
whether the Commission should
exercise its discretion to provide by rule
an opportunity for hearing, rather than
a mandatory hearing, and the reasons in
favor of providing an opportunity for
hearing as opposed to holding a
mandatory hearing. Based upon the
public comments, the Commission may
adopt a final rule which deletes
§ 2.104(f), revises § 2.105 (governing the
content of a Federal Register notice of
proposed action where a mandatory
hearing is not held under § 2.104) to
add, as appropriate, references to
issuance of manufacturing licenses, and
revised § 52.163 to provide an
opportunity for hearing rather than a
mandatory hearing in connection with
the initial issuance of a manufacturing
license.
Commenters’ Response: Several
commenters stated there was no need to
require mandatory hearings for
manufacturing licenses, or that the need
for such hearings was unclear. These
commenters expressed the belief that
such hearings were not an appropriate
method for reviewing and resolving
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technical issues. Some commenters
advised that the decision to request a
hearing be left to either the NRC staff or
stakeholders.
NRC Response: As stated in the
statement of considerations for the
March 13, 2006, proposed rule, the NRC
acknowledges that hearings on initial
issuances of manufacturing licenses are
not required by the AEA (71 FR 12814).
The NRC also agrees with the general
premise of the commenters that
adjudicatory hearings may not be the
best approach for resolving technical
design issues—especially in
uncontested proceedings. Indeed, the
NRC removed the opportunity for
adjudicatory-style hearings for design
certifications as part of the 2004 changes
to 10 CFR part 2 (January 14, 2004; 69
FR 2182). The primary responsibility for
determining the safety of an application
is with the NRC staff, and not the
presiding officer. This is true regardless
of whether the proceeding is contested
or uncontested. Public confidence
would not seem to be enhanced in any
significant manner by the holding of a
hearing where there is no request that
the NRC hold a hearing. Accordingly,
the NRC has decided not to adopt in the
final part 52 rule a requirement for a
‘‘mandatory’’ hearing in connection
with issuance of manufacturing
licenses.
Question 14: As discussed in Section
IV.C.5.g of the statements of
consideration of the March 13, 2006,
proposed rule, the proposed rule would
amend the special backfit requirement
in 10 CFR 52.63(a)(1) to provide the
Commission with the ability to make
changes to the design certification rules
(DCRs) or the certification information
in the generic design control documents
that reduce unnecessary regulatory
burdens. The underlying rationale for
this provision also forms the basis for
amending the Tier 2 change process in
the three DCRs (appendices A, B, and C
of part 52) to incorporate the revised
change criteria in 10 CFR 50.59.
The Commission is considering
adopting an additional provision
[§ 52.63(a)(1)(iv)] in the final rule that
would allow amendments of design
certification rules to incorporate generic
resolutions of design acceptance criteria
(DAC) or other design information
without meeting the special backfit
requirement in the current § 52.63(a)(1).
The applicants for the current DCRs
requested use of DAC in lieu of
providing detailed design information
for certain areas of their nuclear plant
designs, for example, instrumentation
and control systems. Under the
proposed requirements, a generic
change to design certification
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information would have to meet the
special backfit requirement of
§ 52.63(a)(1) or reduce an unnecessary
regulatory burden while maintaining
protection to public health and safety
and the common defense and security.
The Commission adopted this special
backfit requirement to restrict changes
and to require that everyone meet the
same backfit standard for generic
changes, thereby ensuring that all plants
built under a referenced DCR would be
standardized. By allowing a DCR
amendment to include generic
resolutions of DAC or other design
information, the Commission would
enhance its goals for design
certification, for example, early
resolution of all design issues and
finality for those issue resolutions,
which would avoid repetitive
consideration of design issues in
individual combined license
proceedings.
There are currently three ways of
resolving generic design issues: (1) the
combined license applicant that
references a DCR could submit plantspecific resolutions in its application,
which could result in loss of
standardization; (2) a vendor could
submit generic resolutions in topical
reports that, if approved, could but
would not be required to be referenced
in a combined license application; or (3)
the Commission could exempt itself
from the special backfit requirement in
§ 52.63(a)(1) and amend the DCR to
incorporate a generic resolution, which
could result in multiple rulemakings to
revise each DCR to incorporate each
generic resolution. The Commission
intends that any review of a proposed
generic resolution would be performed
under the regulations that are applicable
and in effect at the time that the
approval or amendment is completed.
Therefore, the NRC is requesting
public comments on: (1) whether a
provision should be added to
§ 52.63(a)(1) to allow generic
amendments to design certification
information that meet applicable
regulations in effect at the time that the
rulemaking is completed; and (2)
whether the generic resolutions should
be incorporated into a DCR without
meeting a backfit requirement, which
would provide for completion of the
design certification information and
facilitate standardization, or whether an
application for a generic amendment
should be required to meet a backfit
requirement (e.g., § 50.109).
Commenters’ Response: Some
commenters stated that revisions to NRC
regulations should include the current
10 CFR 52.63, which they believed
should allow the original design
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certification applicant (or its successor)
to obtain amendments to the design
certification rule. These commenters
believed current regulations prevented
any amendment to a design once the
design has been certified by rule (10
CFR 52.63(a)(1)). Some commenters
stated that the design certification
applicant should be able to petition the
NRC for, and obtain, an amendment to
the design certification rule to
incorporate ‘‘beneficial’’ changes to the
design certification, including: (1)
Design changes that would result in
significant improvements in safety; (2)
design changes that would result in
significant improvements in efficiency,
reliability and/or economics; (3) design
changes that result from continuing
engineering or design work or are
required because of lack of availability
of components specified in the original
design certification; and (4) design
changes necessary to correct minor
errors in the original design
certification. Some commenters also
suggested that where proposed changes
involved changes to Tier 2, the design
certification applicant should be able to
make such changes using a § 50.59-like
change process. One commenter noted
that changes to allow an amendment to
the final design certification could
potentially simplify COL applications,
reduce NRC staff resource burden, and
help assure standardization across the
industry.
NRC Response: The NRC has decided
to include an amendment process in the
final rule that: (1) Reduces unnecessary
regulatory burden and maintains
protection to public health and safety
and common defense and security; (2)
provides the detailed design
information necessary to resolve
selected design acceptance criteria; (3)
corrects material errors in the
certification information; (4)
substantially increases overall safety,
reliability, or security of a facility and
the costs of the change are justified; or
(5) contributes to increased
standardization of the certification
information, without meeting the
special backfit requirement in
§ 52.63(a)(1)(ii). These amendments will
apply to all plants that have referenced
or will reference the DCR. The NRC
believes that these amendments will
enhance standardization by further
completing or correcting the
certification information. A detailed
discussion of the amendment process is
provided in Section V.C.7.g of the
Supplementary Information of this
document.
Question 15: In Section IV.J of the
SUPPLEMENTARY INFORMATION of the
March 13, 2006, proposed rule, the NRC
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outlines key principles regarding its
proposal for reporting requirements that
implement Section 206 of the Energy
Reorganization Act, as amended, for
part 52 licenses, certifications, and
approvals. The NRC discusses that the
beginning of the ‘‘regulatory life’’ of a
referenced license, standard design
approval, or standard design
certification under part 52 occurs when
an application for a license, design
approval, or design certification is
docketed. The NRC also cautions,
however, that this does not mean that an
applicant is without Section 206
responsibilities for pre-application
activities because there are two aspects
to the reporting requirements, namely, a
‘‘backward looking’’ or retrospective
aspect with respect to existing
information, and a ‘‘forward looking’’ or
prospective aspect with respect to future
information. For an early site permit
applicant, the retrospective obligation is
that the early site permit holder and its
contractors, upon issuance of the early
site permit, must report all known
defects or failures to comply in ‘‘basic
components,’’ as defined in part 21.
Under the proposed part 21
requirements presented in the proposed
rule, the early site permit holder and its
contractors are required to meet these
requirements upon issuance of the early
site permit. Accordingly, applicants
should procure and control safetyrelated design and analysis or
consulting services in a manner
sufficient to allow the early site permit
holder and its contractors to comply
with the above described reporting
requirements of Section 206, as
implemented by part 21. A similar
argument applies to design certification
applicants. Although the Commission
has not proposed an explicit
requirement imposing part 21 on
applicants for an early site permit or
design certification in the proposed
rule, it is considering adopting such a
requirement in the final part 52
rulemaking because, as a practical
matter, the NRC has to require these
applicants to implement a part 21
program before approval of the early site
permit or design certification. Therefore,
providing explicit part 21 requirements
for applicants would clarify the
Commission’s intent. The Commission
requests stakeholder comment on
whether it should, in the final rule,
impose part 21 reporting requirements
on applicants for early site permits and
design certifications.
Commenters’ Response: Several
commenters were opposed to the
proposed changes to part 21. Some
commenters stated part 21 had been in
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existence for almost 30 years, during
which it was never applied to
applicants. They complained that they
were not aware, and the NRC had not
made them aware, of problems that
would warrant a change. The
commenters noted that applicants take
measures to ensure that they were made
aware of any errors and deficiencies
identified by contractors and suppliers
for work performed on commercial
nuclear projects, because applicants
eventually become holders, and
licensees and want equipment to
operate correctly. Several commenters
were also concerned that the proposal
was contrary to the Energy
Reorganization Act (ERA), which was
the basis for part 21. They believed it
would be inappropriate and contrary to
the ERA to apply part 21 to applicants.
They stated part 21 was established to
implement § 206 of the ERA, which
applies to ‘‘licensees’’ and vendors,
suppliers, and contractors of licensees,
not to ‘‘applicants.’’ These commenters
cited 10 CFR 21.2, stating that the
existing regulations of part 21 apply
only to entities licensed to possess, use,
or transfer radioactive material within
the United States, or to construct,
manufacture, possess, own, operate, or
transfer within the United States, any
production or utilization facility or fuel
storage facility. The commenter believed
applicants did not fall within the scope
of § 206 of the ERA, and it was
inconsistent with the Act to expand the
scope of § 21.2 to include applicants.
Some commenters also noted that it
had been the standard practice for a
construction permit (CP) applicant to
specify part 21 requirements in its
procurement contracts for a plant prior
to issuance of the construction permit.
Some commenters agreed with this
practice because part 21 was applicable
to such contracts once the CP was
issued by the NRC, and expected that
this ‘‘good practice’’ would be
implemented by COL applicants as well.
From a ‘‘practical perspective,’’ the
commenters believed this negated the
need to expand part 21 to applicants.
Some commenters argued that the
obligations for applicants to provide
information to the NRC under proposed
§ 52.6(a) was broader than the obligation
in part 21, and would require applicants
to update and correct their applications
to account for the types of defects and
noncompliances covered by part 21.
These commenters stated the industry
had no objection to proposed § 52.6(a),
which should therefore eliminate the
need to apply part 21 to applicants.
NRC Response: The Commission
proposed part 21 reporting requirements
on applicants for early site permits,
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49369
design certifications, and standard
design approvals in the proposed rule.
A detailed discussion on the
Commission’s rationale for imposing
these requirements in the final rule is
provided in Section V.J of the
SUPPLEMENTARY INFORMATION of this
document.
V. Discussion of Substantive Changes
and Responses to Significant Comments
A. Introduction
The changes to 10 CFR Chapter I are
further discussed by part. Changes to
parts 52 and 50 are discussed first,
followed by changes to other parts in
numerical order. Within each part,
general topics are discussed first,
followed by discussion of changes to
individual sections as necessary. In
addition to the substantive changes, rule
language was revised to make
conforming administrative changes (e.g.,
identification of regulations containing
information collection requirements in
§ 52.11), correct typographic errors,
adopt consistent terminology (e.g.,
‘‘makes the finding under § 52.103(g)’’),
correct grammar, and adopt plain
English. These changes are not
discussed further.
B. Testing Requirements for Advanced
Reactors
This rule amends §§ 50.43, 52.47,
52.79, and 52.157 to achieve clarity and
consistency in the testing requirements
for advanced reactor designs and plants.
This amendment requires applicants for
a combined license, operating license,
or manufacturing license that use new
safety features but do not reference a
certified advanced reactor design to also
perform the design qualification testing
required of certain applicants for design
certification. If a combined license
application references a certified design,
the necessary qualification testing will
have been performed under
§ 52.47(c)(2). The codification of testing
requirements in the original § 52.47 was
a principal issue during the
development of 10 CFR part 52 (see
Section II of 54 FR 15372; April 18,
1989). The requirement to demonstrate
the performance of new safety features
for nuclear power plants that differ
significantly from evolutionary lightwater reactors or that use simplified,
inherent, passive, or other innovative
means to accomplish their safety
functions (advanced reactors), were
included in 10 CFR part 52 to ensure
that these new safety features will
perform as predicted in the applicant’s
safety analysis report, to provide
sufficient data to validate analytical
codes, and that the effects of systems
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interactions are acceptable. The design
qualification testing requirements may
be met with either separate effects or
integral system tests; prototype tests; or
a combination of tests, analyses, and
operating experience. These
requirements implement the
Commission’s policy on proof-ofperformance testing for all advanced
reactors and its goal of resolving all
safety issues before authorizing
construction.
Some commenters stated that it is
unnecessary to apply qualification
testing requirements to combined
license applicants. The Commission
does not agree because, when it
reformed the licensing process for new
nuclear plants with the issuance of part
52, the Commission required applicants
to demonstrate that new safety features
will perform as predicted in the final
safety analysis report. Although the
focus of the NRC at that time was on
applications for design certification, the
Commission intended that testing to
qualify new design features (proof-ofperformance testing) would be required
for all advanced reactors, including
custom designs (see Question 6 at 51 FR
24 646; July 8, 1986). Furthermore, it
would make no sense for the
Commission to require qualification
testing for design certification
applicants (so-called paper designs) and
not require testing for applications to
build and operate an advanced nuclear
power plant. Therefore, the NRC has
implemented its intent in adopting part
52 to resolve issues early and its policy
on advanced reactors that it is necessary
to demonstrate the performance of new
or innovative safety features through
design qualification testing for all
advanced nuclear reactor designs or
plants (including nuclear reactors
manufactured under a manufacturing
license).
This amendment also includes a
requirement in § 50.43(e)(2) for
licensing a prototype plant, as defined
in §§ 50.2 and 52.1, if the plant is used
to meet the testing requirements in
§ 50.43(e)(1). The new § 50.43(e) states
that, if a prototype plant is used to
comply with the qualification testing
requirements, the NRC may impose
additional requirements on siting, safety
features, or operational conditions for
the prototype plant to compensate for
any uncertainties associated with the
performance of the new or innovative
safety features in the prototype plant.
Some commenters stated that it would
be inappropriate to establish or impose
prototype testing on combined license
applicants. Although the Commission
stated that it favors the use of
prototypical demonstration facilities
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and that prototype testing is likely to be
required for certification of advanced
non-light-water designs (see Advanced
Reactor Policy Statement at 51 FR
24646; July 8, 1986, and the statement
of consideration for 10 CFR part 52, 54
FR 15372; April 18, 1989), this rule does
not require the use of a prototype plant
for qualification testing. Rather, this rule
provides that if a prototype plant is used
to qualify an advanced reactor design,
then additional conditions may be
required for the licensed prototype plant
to compensate for any uncertainties
with the unproven safety features. Also,
the prototype plant could be used for
commercial operation.
C. Changes to 10 CFR Part 52
1. Use of Terms: Site Characteristics,
Site Parameters, Design Characteristics,
and Design Parameters in §§ 52.1, 52.17,
52.U0 , 52.39, 52.47, 52.54, 52.79, 52.93,
52.157, 52.158, 52.167, 52.171, and
Appendices A, B, and C to Part 52
The NRC is revising 10 CFR part 52
to clarify the use of the terms, site
characteristics, site parameters, design
characteristics, and design parameters,
in order to ensure that the NRC’s
requirements governing applications for
and issuance of early site permits,
design approvals, design certifications,
combined licenses, and manufacturing
licenses are expressed in clear and
unambiguous terms. This final rule adds
or revises these terms where necessary
to reflect this clarification.
Corresponding changes are made to
§§ 52.17, 52.24, 52.39, 52.47, 52.54,
52.79, 52.93, 52.157, 52.158, 52.167,
52.171, and Section III.E of appendices
A, B, and C to part 52.
The NRC is also adding definitions of
the terms design characteristics, design
parameters, site characteristics, and site
parameters to § 52.1 to clarify the use of
these terms. Design characteristics are
defined as the actual features of a
reactor. Design characteristics are
specified in a standard design approval,
a standard design certification, a
combined license application, or a
manufacturing license. Design
parameters are defined as the postulated
features of a reactor or reactors that
could be built at a proposed site. Design
parameters are specified in an early site
permit. Site characteristics are defined
as the actual physical, environmental
and demographic features of a site. Site
characteristics are specified in an early
site permit or in a final safety analysis
report for a combined license. Site
parameters are defined as the postulated
physical, environmental and
demographic features of an assumed
site. Site parameters are specified in a
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standard design approval, standard
design certification, or a manufacturing
license.
In addition, the NRC is revising
§ 52.79 to include a requirement that a
combined license application
referencing a certified design must
contain information sufficient to
demonstrate that the design of the
facility falls within the site
characteristics and design parameters
specified in the early site permit.
Former § 52.79 included a requirement
that a combined license application
referencing an early site permit contain
information sufficient to demonstrate
that the design of the facility falls
within the parameters specified in the
early site permit. The NRC interprets
parameters to mean the site
characteristics and design parameters as
defined in § 52.1. The NRC is making
similar changes to §§ 52.39 and 52.93.
The need for these changes became
evident during NRC’s review of the pilot
early site permit applications. Because
the NRC is relying on certain design
parameters specified in the early site
permit applications to reach its
conclusions on site suitability, these
design parameters will be included in
any early site permit issued. The NRC
believes that these changes, in the
aggregate, will provide sufficient
clarification on the use of the terms in
question.
As the NRC completes its review of
the first early site permit applications
and prepares for the submittal of the
first combined license application, it is
focusing on the interaction among the
early site permit, design certification,
and combined license processes. The
NRC believes that its review of a
combined license application that
references an early site permit will
involve a comparison to ensure that the
actual characteristics of the design
chosen by the combined license
applicant fall within the design
parameters specified in the early site
permit. NRC review of a combined
license application that references a
design certification will involve a
comparison to ensure that the actual
characteristics of the site chosen by the
combined license applicant fall within
the site parameters in the design
certification. Similarly, if a combined
license applicant references both an
early site permit and a design
certification, the NRC will review the
application to ensure that the site
characteristics in the early site permit
fall within the site parameters in the
referenced design certification and that
the actual characteristics of the certified
design fall within the design parameters
in the early site permit. For these
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reasons, the NRC believes it is important
to make the changes described above in
order to clarify these terms and their use
in part 52 licensing processes.
2. Issuance of Combined and
Manufacturing Licenses (§§ 52.97 and
52.167)
Current § 50.50 sets forth the NRC’s
authority to include conditions and
limitations in permits and licenses
issued by the NRC under part 50.
Similar language delineating the NRC’s
authority in this regard is also set forth
in § 52.24 for early site permits, but is
not included in part 52 with respect to
either combined licenses or
manufacturing licenses. There are two
possible ways of addressing this
omission: § 50.50 could be revised to
refer to combined licenses and
manufacturing licenses, or provisions
analogous to § 50.50 could be added to
the appropriate sections in part 52 for
combined licenses and manufacturing
licenses. Inasmuch as the NRC’s
inclusion of appropriate conditions in
combined licenses is not a technical
matter per se but rather a matter of
regulatory authority, the most
appropriate location for this provision
appears to be in part 52. Inclusion of
these provisions in appropriate portions
of part 52 would be consistent with the
provision applicable to early site
permits in § 52.24. Accordingly, the
NRC is adding the language in § 52.97(c)
for combined licenses, and § 52.167(b)
for manufacturing licenses, which are
analogous to § 50.50.
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3. NRC Staff Information Requests
Section 52.47(a)(3) of the 1989 part 52
rulemaking provided that the NRC staff
would advise the design certification
applicant on whether there was any
additional information beyond that
required to be submitted by that section,
that must be submitted. The March 2006
proposed rule included analogous
provisions (§§ 52.17(d), 52.79(a)(42),
52.137(a)(27), and 52.157(p)) for each of
the other licensing and regulatory
approval processes in part 52. Upon
further consideration in response to a
comment on the March 2006 proposed
rule, the Commission has decided that
these provisions are redundant to
§ 2.102(a), which provides the NRC staff
with overall authority to request
information to support their review of
an application. Accordingly,
§§ 52.17(d), 52.79(a)(42), 52.137(a)(27),
and 52.157(p) of the proposed rule have
not been adopted in the final rule, and
§ 52.47(a)(3) is removed from part 52.
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4. Changes to a Design Certification,
Departures, Variances, Exemptions
External stakeholders have expressed
confusion over the years in public
meetings and in written comments
submitted under various circumstances
with respect to the meaning of the
terms, change to a design certification,
departures, variances, and exemptions.
To clarify the meaning of these terms,
the Commission provides the following
explanation of these terms.
a. Change to a Design Certification
A change to a design certification is
a generic change to the design
certification information which is
approved by the Commission in a
standard design certification rule under
subpart B of part 52. In the four design
certifications currently approved by the
Commission, the design certification
information which is approved by the
Commission is either ‘‘certified
information’’ and is designated as ‘‘Tier
1,’’ or is ‘‘approved’’ and is designated
as ‘‘Tier 2.’’ The term ‘‘generic,’’ means
that if the Commission makes a change
to the design certification, § 52.63(a)
requires that the change (‘‘modification’’
under § 52.63(a)(3)) be applied to each
plant referencing the design certification
rule.
A change to a design certification may
be distinguished from a departure or
variance by understanding that a change
is generic. Therefore, a change to a
design certification is:
(1) Requested by the original design
certification applicant in accordance
with 10 CFR 2.811 (see 10 CFR
2.800(c)), or by any other member of the
public, in a petition for rulemaking
under 10 CFR 2.802;
(2) Applies to all past nuclear power
reactors (including manufactured
reactors) whose applications have
referenced the design certification, as
well as future reactors referencing the
design certification rule; and
(3) Requires the Commission provide
an exemption to the applicant, if the
proposed change is inconsistent with
the one or more of the Commission’s
regulations.
b. Departure
A departure as a plant-specific
‘‘deviation’’ from design information in
either a standard design certification or
a manufacturing license. For a design
certification, a departure is a deviation
from the certification information which
is certified by the Commission in a
standard design certification rule (for
the current four design certification
rules in appendices A through D of part
52, the certification information is ‘‘Tier
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49371
1’’ information). For a manufacturing
license, a departure is a deviation from
any design information approved in the
manufacturing license, including
technical specifications, site parameters
and design characteristics, and interface
requirements.4 A departure may be
distinguished from a change to a
standard design certification rule (i.e., a
change to Tier 1 or Tier 2 information
in a design certification rule) or a
change to the design approved in a
manufacturing license by recalling that
a departure is plant-specific. Therefore,
a departure:
• Concerns certified design
information or manufacturing license
information.
• Is requested by the applicant/
licensee referencing a design
certification or the use of a
manufactured reactor.
• Applies only to the design of the
nuclear power reactor referencing the
design certification or the manufactured
reactor for which a departure is sought
by the applicant/licensee.
• Requires the applicant/licensee to
obtain an exemption from the
referenced design certification if the
proposed departure is inconsistent with
one or more of the Commission’s
regulations. The exemption would be
granted under the provisions of § 52.7
(which references the same criteria for
the granting of exemptions that are set
forth in § 50.12).
c. Variance
A variance is a plant-specific
‘‘deviation’’ from one or more of the site
characteristics, design parameters, or
terms and conditions of an early site
permit, or from the site safety analysis
report. A variance to an early site permit
is analogous to a departure to a standard
design certification, in that it is plantspecific. Therefore, a variance:
(1) Concerns information addressed in
an early site permit;
(2) Is requested by the applicant
referencing an early site permit;
(3) Applies only to the construction
permit or combined license referencing
the early site permit; and
(4) Requires the applicant to also
obtain an exemption from the
Commission’s regulations if the
proposed variance is inconsistent with
one or more of the Commission’s
regulations.
4 As discussed in the section-by-section
discussion for § 52.171, a departure requested by a
holder of a combined license referencing a
manufactured reactor must be in the form of a
license amendment, but the criteria for determining
the request will be the exemption criteria in § 52.7
even though the departure itself may not involve an
exemption.
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d. Exemption
An exemption is a Commissiongranted dispensation from compliance
with one or more of the Commission’s
rules and regulations which would
otherwise apply to an entity, a license,
permit or other approval such as a
standard design certification rule.
Exemption from the requirements in
part 26, or from the requirements in any
particular design certification rule
would be provided under § 52.7.
Exemption from an underlying technical
requirement in part 50 would be
provided under § 50.12. This would be
true even in the course of Commission
adoption of a design certification rule.
For example, if the design certification
did not, at the time of final rulemaking,
comply with a technical requirement in
part 50, the Commission would provide
an exemption to that requirement as
part of the final design certification
rulemaking. Moreover, if the nature of
the technical requirement is such that a
subsequent applicant referencing the
design certification would need an
exemption from compliance with the
requirement as applied to the applicant,
then the Commission would include the
exemption in the design certification
rule itself.
5. General Provisions
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a. Section 52.0, Scope; Applicability of
10 CFR Chapter I Provisions
The Commission is redesignating
former § 52.1, Scope, as § 52.0, Scope;
applicability of 10 CFR Chapter I
provisions, in order to add additional
sections in the General Provisions
portion of part 52. As discussed
elsewhere, the Commission has decided
general provisions, common to all
substantive parts in 10 CFR Chapter I,
should be added to part 52. To provide
enough section numbers, it is necessary
to redesignate former § 52.1 as § 52.0.
Paragraph (a) of § 52.0 is derived from
the text of former § 52.1, but is revised
to include standard design approvals
and manufacturing licenses within the
scope of part 52, and to remove
references to Section 104.b of Atomic
Energy Act of 1954 (AEA), thereby
providing that licenses issued under
part 52 are licenses issued under
Section 103 of the AEA. After passage
of the 1970 amendments to the AEA, all
licenses for commercial nuclear power
plants with construction permits issued
after the date of the amendments were
required to be issued as Section 103
licenses. The NRC interprets the 1970
amendment as requiring combined
licenses under Section 185 to be issued
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as Section 103 licenses.5 Accordingly,
the NRC is revising the scope of part 52
to limit its applicability to licenses
issued under Section 103 of the AEA.
Paragraph (b) of § 52.0 is a new
provision that makes clear that the
regulations in 10 CFR Chapter I apply to
a holder of, or applicant for an approval,
certification, permit, or license issued
under part 52 and that any license,
approval, certification, or permit, issued
under 10 CFR part 52 must comply with
these regulations. The need for this
paragraph was determined as a result of
the July 3, 2003 (68 FR 40026) proposed
rule on part 52. In that proposed rule,
the Commission proposed a new § 52.5
listing all of the licensing provisions in
10 CFR part 50 that also apply to all of
the licensing processes in 10 CFR part
52. This proposal responded to a letter
dated November 13, 2001, from the
Nuclear Energy Institute (NEI), which
stated:
The industry proposes that additional
General Provisions be added to Part 52 in
addition to an appropriate provision on
Written Communications. This approach is
preferable to including cross-references in
Part 52 to Part 50 general provisions because
these provisions typically must be tailored to
apply appropriately to the variety of
licensing processes in Part 52.
Section 52.5, as proposed in 2003,
would have clarified that the general
provisions in 10 CFR part 50 were also
applicable to the new licensing
processes for early site permits,
standard design certifications, and
combined licenses in part 52 (as well as
the licensing and approval processes in
appendices M, N, O, and Q which were
added to part 52 by the 1989 part 52
rulemaking). Although the general
provisions in part 50 did not
specifically refer to the additional
licensing processes in 10 CFR part 52
(and no changes to the language of those
general provisions was proposed), the
Commission believed that proposed
§ 52.5 would make clear that a holder of,
or applicant for an approval,
certification, permit, or license issued
under part 52 must also comply with
those general provisions.
However, few commenters on the July
2003 proposed rule believed that the
proposed § 52.5 would provide greater
clarity. On the contrary, some
commenters indicated that § 52.5 was
overly broad and would impose
burdensome and seemingly
inappropriate new requirements on
applicants for design certifications that
were unwarranted.
5 This may be an academic distinction, in light of
the Energy Policy Act of 2005, Pub. L. No. 109–58,
which removed the need for antitrust reviews of
new utilization facilities.
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Accordingly, in the March 2006
proposed rule, the Commission
proposed a different approach, viz.,
making conforming changes to all of the
regulations in 10 CFR Chapter I to
specify their applicability to the
relevant part 52 regulatory processes,
and to add proposed § 52.0(b) to make
clear that the regulations in 10 CFR
Chapter I apply to the relevant part 52
regulatory processes, and holders and
applicants under part 52. The
Commission did not receive any
comments calling into question the
legality of this approach, or otherwise
questioning the clarity of the proposed
regulatory language. Accordingly, the
Commission is adopting this approach
in the final part 52, including § 52.0(b).
As discussed elsewhere in this
document, the NRC is retaining
appendix N in part 52, and revising this
appendix to apply to part 52 combined
licenses. The provisions of appendix N
to part 52 concern applicants for
combined licenses under part 52.
Therefore, the applicability language in
§ 52.0, by referring to ‘‘licenses’’ under
part 52, need not specifically refer to
appendix N to part 52.
b. Section 52.1, Definitions
Section 52.1 (formerly, § 52.3) is
revised by adding definitions for
decommission, license, licensee, major
feature of the emergency plans,
manufacturing license, modular design,
prototype plant, and standard design
approval. A definition of decommission,
which is identical to that in 10 CFR part
50, is added to part 52 because the final
part 52 rulemaking addresses
decommissioning of nuclear power
reactors with combined licenses under
part 52. Definitions of license and
licensee are added to facilitate the use
of these terms throughout part 52. These
definitions were derived from the
definitions in § 2.4, but were modified
to reflect the regulatory processes in
part 52. The definitions of these terms
in part 2 are modified to be consistent
with the definitions in part 52, and the
definitions of these terms are added in
part 50, to ensure consistency among
parts 2, 50, and 52. Definitions of
manufacturing license and standard
design approval are added to part 52 so
that each of these part 52 license types
are defined.
A definition of modular design is
added to explain the type of modular
reactor design which is the subject of
the second sentence of § 52.103(g). That
provision is added to part 52 to facilitate
the licensing of nuclear plants, such as
the Modular High Temperature GasCooled Reactor (MHTGR) and Power
Reactor Innovative Small Module
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(PRISM) designs, consisting of three or
four nuclear reactors in a single power
block with a shared power conversion
system. During the period that the
power block is under construction, the
NRC could separately authorize
operation for each nuclear reactor when
each reactor and all of its necessary
support systems were completed. In
view of the several definitions of
‘‘modular reactor’’ which are used
within the nuclear industry, the
Commission intends to avoid future
disputes regarding the intended
applicability of § 52.103(g) by defining
the term, modular design, for purposes
of part 52.
The definition of major feature of the
emergency plans is being added in the
final rule, based on commenters’
responses to Question 2 in Section V of
the Supplementary Information of the
2006 proposed rule, to clarify what is
meant by this term as it is used in
§§ 52.17, 52.18, 52.39, and 52.79. The
definition states that a major feature of
the emergency plans means an aspect of
those plans necessary to: (1) address in
whole or part, one or more of the sixteen
standards in § 50.47(b), or (2) describe
the emergency planning zones as
required in § 50.33(g). The goal of the
‘‘major features’’ option in § 52.17(b) is
an NRC finding that the proposed major
features are acceptable as elements of a
complete and integrated emergency plan
that would be considered later, when
the early site permit is referenced in a
license application. This is not the same
level of finality as the ‘‘reasonable
assurance’’ finding that would be made
in connection with the approval of a
completed and integrated plan.
However, the NRC would not re-review,
at the COL stage, information that
provided the basis for the NRC approval
of major features in an ESP but would
address integration of approved major
features with the balance of emergency
planning information provided in the
COL applications necessary to support
the NRC’s reasonable assurance finding;
and updated emergency planning
information required by § 52.39(b).
A definition of prototype plant is
added to explain the type of nuclear
power plant that the NRC is addressing
in §§ 52.43, 52.47(b), 52.79, and 52.157.
A prototype plant is a licensed nuclear
reactor test facility that is similar to and
representative of either the first-of-akind or standard nuclear plant design in
all features and size, but may have
additional safety features. The purpose
of the prototype plant is to perform
testing of new or innovative safety
features for the first-of-a-kind nuclear
plant design, as well as being used as a
commercial nuclear power facility.
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c. Section 52.2, Interpretations; and
§ 52.4, Deliberate Misconduct
The former section on interpretations
in § 52.5 is retained and redesignated
without change as § 52.2. The former
section on deliberate misconduct in
§ 52.9 is retained and redesignated
without change as § 52.4.
d. Section 52.3, Written
Communications; § 52.5, Employee
Protection; § 52.6, Completeness and
Accuracy of Information; § 52.7,
Specific Exemptions; § 52.8, Combining
Licenses; § 52.9, Jurisdictional Limits;
and § 52.10, Attacks and Destructive
Acts
Section 52.3, Written
communications, which is essentially
identical with the current § 50.4, is
added to address the requirements for
correspondence, reports, applications,
and other written communications from
applicants, licensees, or holders of a
standard design approval to the NRC
concerning the regulations in part 52.
Section 52.5, which is largely
identical with the current § 50.7, is
added to make clear that discrimination
against an employee for engaging in
certain protected activities concerning
the regulations in part 52 is prohibited.
This section differs from its part 50
counterpart, in that the Commission has
added a provision on coordination with
the requirements in 10 CFR part 19.
Section 52.6, which is identical with
the current § 50.9, is added to require
that information provided to the
Commission by a licensee, a holder of
a standard design approval, and an
applicant under part 52, and
information required by statute or by the
NRC’s regulations, orders, or license
conditions to be maintained by a
licensee, holder of a standard design
approval, and applicant under part 52
(including the applicant for a standard
design certification under part 52
following Commission adoption of a
final design certification rule) be
complete and accurate in all material
respects. The Commission has corrected
an error in the proposed rule version of
paragraph (a) of § 52.6. In the proposed
rule, the first sentence began,
‘‘Information provided to the
Commission by a licensee (including a
construction permit holder, and a
combined license holder) * * *.’’ In the
final rule, this phrase has been corrected
to read, ‘‘Information provided to the
Commission by a licensee (including an
early site permit holder, a combined
license holder, and a manufacturing
license holder) * * *.’’ This provision
applies to licenses issued under part 52
and not to licenses issued under part 50.
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49373
Section 52.7, which is essentially
identical with current § 50.12, is added
to address the procedure and criteria for
obtaining an exemption from the
requirements of part 52. Although part
50 contains a provision (§ 50.12) for
obtaining specific exemptions, § 50.12
by its terms applies only to exemptions
from part 50. Although it would be
possible to revise § 50.12 so that its
provisions apply to exemptions from
part 52, this is inconsistent with the
general regulatory structure of 10 CFR,
wherein each part is treated as a
separate and independent regulatory
unit. The NRC notes that the exemption
provisions in § 52.7 are generally
applicable to part 52, and do not
supercede or otherwise diminish more
specific exemption provisions that are
in part 52.
Section 52.8, which combines into a
single section regulatory provisions
which are addressed in separate
regulations in part 50, is added to clarify
that these regulatory provisions also
apply to part 52 licenses.
Paragraph (a) of § 52.8, which is
analogous to § 50.31, is added to make
clear that an applicant for a license
under part 52 may combine in one
application, several applications for
different kinds of licenses under various
regulations in 10 CFR Chapter I. Section
50.31 currently provides that an
applicant may combine in one
application, several applications for
different kinds of licenses under various
regulations in 10 CFR Chapter I. The
plain reading of this language, given
that this provision is located in part 50,
is that a part 50 application may contain
in one application other applications for
different licenses in other parts of 10
CFR Chapter I. Thus, § 50.31 would not
appear to allow a part 52 application (as
for a combined license) to combine in
one application other applications for
different license in other parts of 10 CFR
Chapter I. Accordingly, paragraph (a) of
§ 52.8 of the final rule makes clear that
a part 52 application may be combined
with applications for different licenses
in other parts of 10 CFR Chapter I. This
provision was not included in the
March 2006 proposed rule, inasmuch as
the NRC determined the desirability of
including in part 52 a provision
analogous to § 50.31 only after the
publication of the March 2006 proposed
rule.
Paragraph (b) of § 52.8, which is
analogous to § 50.32, is added to make
clear that an applicant for a license,
standard design certification, or design
approval under part 52 may incorporate
by reference in its application
information contained in other
documents provided to the Commission,
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but must clearly specify the information
to be incorporated. This provision was
also not included in the March 2006
proposed rule, inasmuch as the NRC
determined the desirability of including
in part 52 a provision analogous to
§ 50.32 only after the publication of the
March 2006 proposed rule.
Paragraph (c) of § 52.8, which is
analogous to § 50.52, is added to clarify
the Commission’s authority under
Section 161.h of the AEA to combine
NRC licenses, such as a special nuclear
materials license under part 70 for the
reactor fuel, with a combined license
under part 52. Analogous to the
situation with respect to § 50.31, the
language in § 50.52 would not appear to
allow the Commission to combine into
a single part 52 license, other non-part
52 licenses. Inasmuch as these changes
to § 52.8 constitute revisions to the
Commission’s rules of procedure and
practice, the Commission may adopt
them in final form without further
notice and comment, under the
rulemaking provisions of the APA, 5
U.S.C. 553(b)(A).
Section 52.9, which is identical with
§ 50.53, is added to clarify that NRC
licenses issued under part 52 do not
authorize activities which are not under
or within the jurisdiction of the United
States; an example would be the
construction of a nuclear power reactor
outside the territorial jurisdiction of the
United States which uses a design
identical to that approved in a standard
design certification rule in part 52.
Section 52.10 is added because there
is no specific provision in part 52
specifying that the Commission’s
longstanding determination with respect
to the lack of need for design features
and other measures for protection of
nuclear power plants against attacks by
enemies of the United States, or the use
of weapons deployed by United States
defense activities, applies to part 52
applicants. The Commission’s
determination, which was upheld by the
U.S. Court of Appeals for the D.C.
Circuit, see Siegel v. Atomic Energy
Commission, 400 F.2d 778 (D.C. Cir
1968), is currently codified for part 50
applicants in § 50.13. Although it would
be possible to revise § 50.13 so that its
provisions apply to applications under
part 52, this would be inconsistent with
the overall regulatory pattern of 10 CFR
Chapter I, whereby each part is treated
as a separate and independent
regulatory unit. Moreover, any changes
to § 50.13 might erroneously be viewed
as changes to the Commission’s
substantive determination on this
matter. For these reasons, the
Commission is adding new § 52.10 to
part 52, which is essentially identical
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with § 50.13. Inclusion of this provision
in part 52 makes clear that applications
for combined licenses, manufacturing
licenses, design certification
rulemakings, standard design approvals,
and amendments to these licenses,
rulemakings, and approvals under part
52 need not provide design features or
other measures for protection of nuclear
power plants against attacks by enemies
of the United States, or the use of
weapons deployed by U.S. defense
activities. In adding § 52.10, the
Commission emphasizes that it is not
changing in any way, nor is it intending
to revisit in this rulemaking, the
Commission’s determination with
respect to the lack of need for design
features or other measures for protection
of nuclear power plants against attacks
by enemies of the United States, or the
use of weapons deployed by U.S.
defense activities. The Commission is
simply making it clear that its
longstanding determination applies to
applications under part 52 just as it
applies to applications under part 50.
6. Subpart A, Early Site Permits
a. Emergency Preparedness
Requirements for Early Site Permit
Applicants
The NRC is amending §§ 52.17(b),
52.18, and 52.39 to address changes to
emergency preparedness requirements
for early site permit applicants. The
NRC is amending § 52.17(b)(1), which
requires that an early site permit
application identify physical
characteristics unique to the proposed
site that could pose a significant
impediment to the development of
emergency plans. The NRC is adding a
sentence to require that, if physical
characteristics that could pose a
significant impediment to the
development of emergency plans are
identified, the application must identify
measures that would, when
implemented, mitigate or eliminate the
significant impediment. The NRC
believes this addition is necessary to
clarify the NRC’s expectations in cases
where a physical characteristic exists
that could pose a significant
impediment to the development of
emergency plans. Simply identifying
these physical characteristics alone does
not provide the NRC with enough
information to determine if these
characteristics are likely to pose a
significant impediment to the
development of emergency plans.
Similarly, the Commission is amending
§ 52.18 to require that the Commission
determine whether the information
required of the applicant by
§ 52.17(b)(1) shows that there is no
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significant impediment to the
development of emergency plans that
cannot be mitigated or eliminated by
measures proposed by the applicant
[emphasis added].
The NRC is amending
§§ 52.17(b)(2)(i), 52.17(b)(2)(ii), and
52.18 to clarify that any emergency
plans or major features of emergency
plans proposed by early site permit
applicants must be in accordance with
the applicable standards of 10 CFR
50.47 and the requirements of appendix
E to part 50. These changes clarify the
standards applicable to emergency
preparedness information supplied with
an early site permit application. The
NRC is also amending §§ 52.17(b)(1),
(b)(2), and (b)(4) to indicate that the
emergency preparedness information
supplied in the early site permit
application must be included in the site
safety analysis report. This change is
necessary for consistency with past
practice and with the requirements for
combined license applicants in
§ 52.79(a) that require emergency
preparedness information to be
included in the final safety analysis
report. Note that the proposed rule only
included these changes in § 52.17(b)(2).
In the final rule, the NRC is making the
additional conforming changes in
§§ 52.17(b)(1) and (b)(4).
The NRC is adding new § 52.17(b)(3)
to require that any complete and
integrated emergency plans submitted
for review in an early site permit
application must include the proposed
inspections, tests, and analyses that the
holder of a combined license
referencing the early site permit shall
perform, and the acceptance criteria that
are necessary and sufficient to provide
reasonable assurance that, if the
inspections, tests, and analyses are
performed and the acceptance criteria
met, the facility has been constructed
and would operate in conformity with
the license, the provisions of the AEA,
and the NRC’s regulations. The NRC is
making these amendments for
consistency with the requirements in
subpart C of part 52 regarding the
review of emergency plans and to
provide additional finality to ESP
holders. The NRC believes that its
review of complete and integrated plans
included in an early site permit
application should be no different than
its review of emergency plans submitted
in a combined license application, given
that the NRC must make the same
findings in both cases, namely, that the
plans submitted by the applicant
provide reasonable assurance that
adequate protective measures can and
will be taken in the event of a
radiological emergency. The NRC will
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not be able to make the required finding
without the inclusion of proposed
ITAAC in an early site permit
application that includes complete and
integrated emergency plans. In the final
rule, the NRC has added an allowance
that major features of an emergency plan
submitted under paragraph (b)(2)(i) of
§ 52.17 may include proposed ITAAC.
This will give an applicant that has
proposed major features additional
opportunities to achieve finality on
major features in cases where ITAAC
can be included to address
implementation aspects of the major
feature.
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b. Section 52.13, Relationship to Other
Subparts
The title of § 52.13 is revised from
‘‘Relationship to subpart F of 10 CFR
part 2 and appendix Q of this part,’’ to
‘‘Relationship to other subparts,’’ to
reflect the revised scope of this section,
which has been refocused on part 52.
c. Section 52.16, Contents of
Applications; General Information and
§ 52.17, Contents of Applications;
Technical Information
The NRC is adding § 52.16 to include
the general content requirements from
§ 52.17(a)(1).
The title of § 52.17 is revised to read,
‘‘Contents of applications; technical
information.’’ In response to several
comments on the proposed rule, the
NRC is including a general
grandfathering provision in § 52.17(a)
that states, ‘‘For applications submitted
before September 27, 2007, the rule
provisions in effect at the date of
docketing apply unless otherwise
requested by the applicant in writing.’’
This revision reflects the Commission’s
belief that ESPs currently under review
or issued prior to the effective date of
the final part 52 rule should not be
required to be modified by this rule.
Section 52.17(a)(1) is amended to state
that the early site permit application
must specify the range of facilities for
which the applicant is requesting site
approval (e.g., one, two, or three
pressurized-water reactors). This new
language provides a clearer and more
complete statement of the applicant’s
proposal with respect to the facilities
which may be located under the early
site permit. This facilitates NRC review,
as well as providing adequate notice to
potentially-affected members of the
public and State and local governmental
entities. The NRC assumes that an
applicant for an early site permit may
not know what type of nuclear plant
may be built at the site. Therefore, the
application must specify the postulated
design parameters for the range of
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reactor types, the numbers of reactors,
etc., to increase the likelihood that
approval of the site will resolve issues
with respect to the actual plant or plants
that the combined license or
construction permit applicant decides to
build. In a letter dated November 13,
2001 (comment 27 on draft proposed
rule text), NEI stated, ‘‘The proposed
change is too limited. To address the
required assessment of major SSCs
[structures, systems, and components]
that bear on radiological consequences
and all items 52.17.a.1.i–vii (sic.),
industry recommends new § 52.17a.2.’’
The NRC disagrees with NEI’s proposal
to have a separate provision for
applicants who have not determined the
type of plant that they plan to build at
the proposed site. The NRC expects that
some applicants for an early site permit
may not have decided on a particular
type of nuclear power plant, therefore,
§ 52.17(a)(1) was revised to address this
situation.
The NRC is amending § 52.17(a)(1) to
eliminate all references to § 50.34. The
references to § 50.34(a)(12) and (b)(10)
are removed because these provisions
require compliance with the earthquake
engineering criteria in appendix S to
part 50 and are not requirements for the
content of an application. The reference
to § 50.34(b)(6)(v), which requires plans
for coping with emergencies, is also
being removed. All requirements related
to emergency planning for early site
permits are addressed in § 52.17(b) and
other plans for coping with emergencies
will be addressed in a combined license
application. Finally, the reference to the
radiological consequence evaluation
factors identified in § 50.34(a)(1) is
being removed and the requirements are
included in § 52.17(a)(1). The NRC is
modifying the existing requirement for
early site permit applications to
describe the seismic, meteorological,
hydrologic, and geologic characteristics
of the proposed site to add that these
descriptions must reflect appropriate
consideration of the most severe of the
natural phenomena that have been
historically reported for the site and
surrounding area and with sufficient
margin for the limited accuracy,
quantity, and time in which the
historical data have been accumulated.
This addition is to ensure that future
plants built at the site would be in
compliance with general design
criterion 2 from appendix A to part 50
which requires that structures, systems,
and components important to safety be
designed to withstand the effects of
natural phenomena such as earthquakes,
tornadoes, hurricanes, floods, tsunami,
and seiches without loss of capability to
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perform their safety functions. The
design bases for these structures,
systems, and components are required
to reflect appropriate consideration of
the most severe of the natural
phenomena that have been historically
reported for the site and surrounding
area, with sufficient margin for the
limited accuracy, quantity, and time in
which the historical data have been
accumulated.
The NRC is adding several
requirements to § 52.17(a)(1). A
requirement is added to § 52.17(a)(1)(x)
that applications for early site permits
include information to demonstrate that
adequate security plans and measures
can be developed. This requirement is
inherent in current § 52.17(a)(1) which
states that site characteristics must
comply with 10 CFR part 100. Section
100.21(f) states that site characteristics
must be such that adequate security
plans and measures can be developed.
A new § 52.17(a)(1)(xi) is added to
require early site permit applications to
include a description of the quality
assurance program applied to site
activities related to the future design,
fabrication, construction, and testing of
the structures, systems, and components
of a facility or facilities that may be
constructed on the site. This change was
made for consistency with changes to
§ 50.55 and appendix B to part 50. A
discussion of these changes can be
found in this section under the heading
‘‘Appendix B to Part 50.’’
An additional requirement is added to
§ 52.17(a)(1) that is taken from
§ 50.34(h), and that the NRC believes
should be applicable to early site
permits. Section 52.17(a)(1)(xii) requires
that early site permit applications
include an evaluation of the site against
the applicable sections of the standard
review plan (SRP) revision in effect 6
months before the docket date of the
application. The SRP requirement
currently exists for applicants for
construction permits, operating licenses,
and combined licenses. The NRC also
believes it should be applicable to
applicants for early site permits because
they are partial construction permits
that can be referenced in applications
for construction permits or combined
licenses and because it will facilitate the
NRC’s review of the early site permit
application.
The NRC is not requiring applicants
to evaluate their site against the
applicable sections of Regulatory Guide
(RG) 1.206, ‘‘Combined License
Applications for Nuclear Power Plants.’’
However, the NRC believes that the
applicable portions of RG 1.206 can
provide useful guidance to ESP
applicants in preparing their
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applications and that use of this
guidance will facilitate the NRC’s
review.
The NRC is making a change to
§ 52.17(a)(1) based on several comments
on the proposed rule. The NRC is
deleting the requirement in proposed
§ 52.17(a)(1)(x) that required ESP
applicants to address impacts on
operating units of constructing new
units on existing sites, as well as
include a description of the managerial
and administrative controls to be used
to assure that the limiting conditions of
operation for existing units will not be
exceeded. The NRC is deleting this
requirement because it was contrary to
the industry-NRC understanding
documented in correspondence in 2003
regarding ESP Topic ESP–19 [see NEI
letter dated May 14, 2003 (ML031920U0
6), and NRC letter dated August 11,
2003 (ML031490478)] and because the
COL applicant is in the best position to
provide such information, since it will
have final information regarding the
facility design and construction plans.
The NRC may include a condition in
early site permits that would require the
permit holder to notify the operating
plant licensee prior to conducting any
activities authorized under § 52.25.
These controls should be sufficient to
evaluate construction activities at a site
with an existing operating unit. The
NRC has deleted this provision from
subpart A in the final rule. COL
applicants will, however, continue to be
required to meet this provision under
§ 52.79(a)(31).
The NRC is moving the environmental
provisions in former § 52.17(a)(2) to
§ 51.50(b). Revised § 52.17(a)(2) simply
states that an early site permit
application must contain a complete
environmental report as required by 10
CFR 51.50(b). A discussion of the final
rule provisions related to the NRC’s
environmental review at the ESP stage
can be found in the Supplementary
Information section that discusses
changes to 10 CFR part 51.
The NRC is amending § 52.21 to
reflect clarifications provided in part 51
that an early site permit applicant has
the flexibility of either addressing the
matter of alternative energy sources in
the environmental report supporting its
early site permit application, or
deferring consideration of alternative
energy sources to the time that the early
site permit is referenced in a licensing
application. These changes to § 52.21
clarify that the NRC’s EIS need not
address the need for power or
alternative energy sources (and therefore
these matters may not be litigated) if the
early site permit applicant chooses not
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to address these matters in its
environmental report.
The NRC is amending § 52.17(c) to
clarify that if the applicant wants to
request authorization to perform limited
work activities at the site after receipt of
the early site permit, the application
must contain an identification and
description of the specific activities that
the applicant seeks authorization to
perform. This request by the early site
permit applicant would be separate
from, but not in addition to, a request
to perform activities under 10 CFR
50.10(e)(1). The submittal of this
descriptive information will enable the
NRC staff to perform its review of the
request, consistent with past practice, to
determine if the requested activities are
acceptable under § 50.10(e)(1). If an
applicant for a construction permit or
combined license references an early
site permit with authorization to
perform limited work activities at the
site and subsequently decides to request
authorization to perform activities
beyond those authorized under § 52.U0
(c), those additional activities will have
to be requested separately under
§ 50.10(e)(1). Some minor changes were
made to the rule language in § 52.17(c)
in the final rule to remove references to
information being included in either the
site safety analysis report or the
environmental report. The NRC
concluded that it is preferable to
include both the list of proposed
activities and the redress plan as a
separate document in the application,
outside of both the site safety analysis
report and the environmental report.
The NRC’s conclusion is based on the
fact that the requirements in § 50.10(e)
address both safety and environmental
issues. Additional changes were made
to §§ 51.50, 52.79(a), and 52.80 to
implement this concept.
d. Section 52.24, Issuance of Early Site
Permit
The NRC is revising § 52.24 to clarify
the information that the NRC must
include in the early site permit when it
is issued. Section 52.24 is also being
amended to be more consistent with the
parallel provision in § 50.50, Issuance of
licenses and construction permits, by
requiring the NRC to ensure that there
is reasonable assurance that the site is
in conformity with the provisions of the
AEA, and the NRC’s regulations; that
the applicant is technically qualified to
engage in any activities authorized; and
that issuance of the permit will not be
inimical to the common defense and
security or to the health and safety of
the public.
Section 52.24 is being amended to
provide that the early site permit must
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state the site characteristics and design
parameters, as well as the ‘‘terms and
conditions,’’ of the early site permit,
rather than the ‘‘conditions and
limitations’’ as was formerly provided.
The change provides consistency with
§ 52.39(a)(2), and in particular
§ 52.39(a)(2)(iii) of the former
regulations, which also refers to ‘‘site
parameters’’ (corrected to ‘‘site
characteristics’’ in the final rule) and
‘‘terms and conditions.’’ Section
52.24(c) is being added to require that
the early site permit state the activities
that the permit holder is authorized to
perform at the site. This change is
consistent with the revision to § 52.17(c)
where the applicant must specify the
activities that it is requesting
authorization to perform at the site
under § 50.10(e)(1).
The NRC is revising paragraph (b) of
this section based on public comments.
Paragraph (b) states that the early site
permit shall specify the site
characteristics, design parameters, and
terms and conditions of the early site
permit the NRC deems appropriate.
Paragraph (b) further states that, before
issuance of either a construction permit
or combined license referencing an early
site permit, the Commission shall find
that any relevant terms and conditions
of the early site permit have been met.
The NRC is revising this paragraph to
add a provision that any terms or
conditions of the early site permit that
could not be met by the time of issuance
of the construction permit or combined
license, must be set forth as terms or
conditions of the construction permit or
combined license. This provision is
needed to address terms or conditions of
the early site permit that are related to
activities that will not take place until
after issuance of the construction permit
or combined license, such as
construction activities. A similar change
is being made to § 52.79(b)(3).
e. Section 52.27, Duration of Permit
Section 52.27 provides for the
duration of an early site permit. The
NRC did not propose any changes to
this section in the proposed rule.
However, in the final rule, the NRC is
making several revisions. First, the NRC
is revising former § 52.27(b)(1) [final
§ 52.27(b)]. This paragraph states that an
early site permit continues to be valid
beyond the date of expiration in any
proceeding on a construction permit
application or a combined license
application that references the early site
permit and is docketed before the date
of expiration of the early site permit, or,
if a timely application for renewal of the
permit has been filed, before the
Commission has determined whether to
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renew the permit, consistent with the
‘‘Timely Renewal’’ doctrine of the
Administrative Procedure Act. This
section is changed in the final rule by
deleting the term, ‘‘filing,’’ and
substituting the term, ‘‘docketing.’’ The
NRC believes that timely renewal
protection should only be provided to
those applications which are of
sufficient quality to be docketed. This is
consistent with the requirement in
§ 2.109(b) requiring filing of a
‘‘sufficient’’ application for renewal of
operating licenses as a prerequisite for
the applicability of the timely renewal
protection. Inasmuch as the changes to
former § 52.72(b)(1) constitute revisions
to the NRC’s rules of procedure and
practice, the NRC may adopt them in
final form without further notice and
comment, under the rulemaking
provisions of the APA, 5 U.S.C.
553(b)(A).
The NRC is also making revisions to
§ 52.27 based on public comments. The
NRC is deleting proposed § 52.27(b)(2)
because it was inconsistent with
proposed § 52.39(d) and the NRC’s
intention that the early site permit be
subsumed into the construction permit
or combined license once the
construction permit or combined license
is issued. To make this intention clear,
the NRC is also adding new § 52.27(d)
in the final rule. This provision states
that upon issuance of a construction
permit or combined license, a
referenced early site permit is
subsumed, to the extent referenced, into
the construction permit or combined
license. By ‘‘subsumed’’ the NRC means
that the information that was contained
in the early site permit site safety
analysis report (SSAR) becomes part of
the referencing combined license final
safety analysis report upon issuance of
the combined license in the same
manner as if the combined license
applicant had not referenced an early
site permit. The NRC is including the
phrase ‘‘to the extent referenced,’’ to
indicate that it is not all of the
information submitted in the early site
permit application that is subsumed
into the combined license, but, only that
information that is contained in the
SSAR and identified by the applicant as
being referenced in the combined
license application. This subsumption
of the early site permit into the
referencing license affects the way
changes to the early site permit
information will be handled because it
breaks the tie to the finality provisions
in § 52.39. After issuance of the
construction permit or combined
license, § 52.39 no longer applies to the
early site permit information and such
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information will be covered by the same
finality provisions as the rest of the
information in the FSAR (with the
exception of any referenced design
certification information), as outlined in
§ 52.98 (e.g., in accordance with
§§ 50.54, 50.59, etc.).
f. Section 52.28, Transfer of Early Site
Permit
Section 52.28 is being added to state
that transfer of an early site permit from
its existing holder to a new applicant
would be processed under § 50.80,
which contains provisions for transfer of
licenses. In a letter dated November 13,
2001 (comment 19 on draft proposed
rule text), the NEI recommended that a
new section be added to part 52 to
clarify the process for transfer of an
early site permit. The NRC has
determined that a new section is not
necessary because an early site permit is
a partial construction permit and,
therefore, is considered to be a license
under the AEA. The NRC believes that
the procedures and criteria for transfer
of utilization facility licenses in 10 CFR
50.80 (and the procedures in subpart M
of part 2 for the conduct of any hearing)
should apply to the transfer of an early
site permit. Changes that the NRC has
made to § 50.80 in the final rule to
address comments made regarding
requirements for transfer of an early site
permit can be found in Section V.D.8.a
of the SUPPLEMENTARY INFORMATION of
this document.
g. Section 52.33, Duration of Renewal
Section 52.33 has been revised in the
final rule to clarify that the renewal
period for an early site permit includes
any remaining years on the early site
permit then in effect before renewal.
This change was made to be consistent
with the NRC’s regulations concerning
renewal of nuclear power plant
operating licenses as specified in § 54.31
of this chapter.
h. Section 52.37, Reporting of Defects
and Noncompliance; Revocation,
Suspension, Modification of Permits for
Cause
Section 52.37 is removed because this
provision only contains a crossreference to 10 CFR part 21 and
§ 50.100, and the NRC is making
conforming changes to those
requirements to account for
requirements for early site permits.
i. Section 52.39, Finality of Early Site
Permit Determinations
The NRC is revising § 52.39 to address
the finality of an early site permit.
While some of the changes are
conforming or clarifying, others
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49377
represent a change from the finality
provisions in the former § 52.39.
Paragraph (a)(2) of the former rule
distinguishes among issues alleging
that: (1) a ‘‘reactor does not fit within
one or more of the site parameters,’’
which are to be treated as valid
contentions (paragraph (a)(2)(i)); (2) a
‘‘site is not in compliance with the
terms of an early site permit,’’ which are
to be subject to hearings under the
provisions of the Administrative
Procedure Act (paragraph (a)(2)(ii)); and
(3) the ‘‘terms and conditions of an early
site permit should be modified,’’ which
are to be processed in accordance with
10 CFR 2.206(a)(2)(iii). With the benefit
of hindsight and experience gained in
reviewing the first three early site
permit applications, the NRC believes
that all issues concerning a referenced
early site permit may be characterized
as:
(1) Questions regarding whether the
site characteristics, design parameters,
or terms and conditions specified in the
early site permit have been met;
(2) Questions regarding whether the
early site permit should be modified,
suspended, or revoked; or
(3) Significant new emergency
preparedness or environmental
information not considered on the early
site permit.
Questions about the referencing
application demonstrating compliance
with the early site permit are
fundamentally questions of compliance
with the early site permit. They do not
attack the underlying validity of the
permit. For example, if a person
questions whether the design
characteristics of the nuclear power
facility that the referencing applicant
proposes to construct on the site falls
within the design parameters specified
in the early site permit, it is a matter of
compliance with the early site permit.
These compliance matters are specific to
the proceeding for the referencing
application, and the NRC concludes that
a question about whether the
referencing application complies with
the early site permit may be viewed as
question/material to the proceeding and
appropriate for consideration in the
referencing application proceeding
(assuming that all relevant Commission
requirements in 10 CFR part 2, such as
standing and admissibility, are met).
The NRC also regards new emergency
preparedness information submitted in
the referencing application that
substantially alters the bases for a
previous NRC conclusion or constitutes
a sufficient basis for the Commission to
modify or impose new terms and
conditions related to emergency
preparedness as an issue material to the
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proceeding and appropriate for
consideration as a contention in the
referencing application proceeding
(assuming that all relevant Commission
requirements in 10 CFR part 2, such as
standing and admissibility, are met).
This is a change to the standard that was
provided in the proposed rule for new
emergency preparedness information
and is based on public comments. The
proposed rule standard for litigation of
emergency preparedness matters was
‘‘new or additional information * * *
which materially affects the
Commission’s earlier determination on
emergency preparedness, or is needed to
correct inaccuracies in the emergency
preparedness information approved in
the early site permit.’’ Because the final
rule language suggested by the
commenters is the definition that the
NRC gave for information that could
‘‘materially affect’’ the Commission’s
earlier decision, as indicated in the
SUPPLEMENTARY INFORMATION section of
the 2006 proposed rule, the NRC
believes it appropriate to use this
language in the final rule itself. The
NRC has decided to drop the language
that referred to information ‘‘needed to
correct inaccuracies’’ because the
language, by itself, could have allowed
litigation of issues not significant to
safety. The NRC believes that the final
rule language encompasses all
significant emergency preparedness
matters that should be subject to
litigation.
Any significant environmental issue
that was not resolved in the early site
permit proceeding, or any issue
involving the impacts of construction
and operation of the facility that was
resolved in the early site permit
proceeding for which significant new
information has been identified may
also be the subject of a contention
during the proceeding on the
referencing application. The NRC is also
making a change to this standard in the
final rule based on public comment. The
standard in the final rule more closely
reflects the NRC’s obligation under
NEPA to address new and significant
information in a COL that references an
early site permit. Additional discussion
of this subject can be found in the
discussion of changes in 10 CFR part 51,
in the SUPPLEMENTARY INFORMATION
section of this document.
Because new emergency planning or
environmental information, if any, will
be identified only at the time a license
application referencing the early site
permit is submitted to the NRC, the NRC
believes it is appropriate to address
these issues in the proceeding on the
referencing application. Other questions
regarding whether the permit should be
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modified, suspended, or revoked will be
challenges to the validity of the early
site permit. These challenges may be
framed in many different ways, e.g., a
Commission error at the time of
issuance; or actual changes to the site
have occurred since issuance of the
permit that render some aspect of the
permit irrelevant or inadequate to
protect public health and safety or
common defense and security. The
Commission’s process for challenges to
the validity of a license is contained in
10 CFR 2.206. Accordingly, the
Commission concludes that challenges
to the validity of an early site permit
should be processed in accordance with
§ 2.206. In the Commission’s view, a
variance is not fundamentally a
challenge to the validity of the early site
permit, because it requests dispensation
from compliance with some aspect of
the permit whose validity remains
undisputed. Therefore, the Commission
concludes that variances should be
treated as proceeding-specific issues of
compliance that are potentially valid
subjects of a contention in a proceeding
for a referencing application.
The revisions to § 52.39 are in
agreement with these Commission
conclusions. Section 52.39 is being
divided into five paragraphs addressing
different aspects of early site permit
finality. Each paragraph is provided
with a subtitle characterizing the subject
matter addressed in that paragraph.
Section 52.39(a) focuses on how the
NRC accords finality to an early site
permit, with § 52.39(a)(1) setting forth
the circumstances under which the NRC
may modify an early site permit. The
rule language is based upon the existing
regulation, but adds additional
circumstances. Section 52.39(a)(1)(iii)
provides that the NRC may modify the
early site permit if it determines a
modification is necessary based on an
update to the emergency preparedness
information under § 52.39(b). Section
52.39(a)(1)(iv) provides that the NRC
may modify the early site permit if a
variance is issued under proposed
§ 52.39(d) (paragraph (b) in the former
regulations); the NRC considers this a
conforming change inasmuch as the
former regulation provided for issuance
of variances.
The NRC is clarifying what aspects of
the early site permit are subject to the
change restrictions in § 52.39(a)(1) by
substituting the phrase, ‘‘terms and
conditions’’ of an early site permit for
the former term, ‘‘requirements.’’ Under
the new language, the NRC may not
change or impose new site
characteristics, design parameters, or
terms and conditions on the early site
permit, including emergency planning
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requirements, unless the special
backfitting criteria in § 52.39(a)(1) are
satisfied. No substantive change is
intended by this clarification; the
language would specify more clearly the
broad scope of matters in an early site
permit which the NRC intended to
finalize. The phrase, ‘‘site
characteristics, or terms, or conditions,
including emergency planning
requirements,’’ is used consistently
throughout § 52.39 and corresponding
provisions in the revisions to § 52.79.
Section 52.39(a)(2) describes how the
NRC treats matters resolved in the early
site permit proceeding in subsequent
proceedings on applications referencing
the early site permit, and is drawn from
the former language of § 52.39(a)(2). In
the final rule, the NRC has included a
provision extending this finality to
enforcement hearings other than those
proceedings initiated by the
Commission under paragraph (a)(1) of
this section. This will ensure that
finality of an early site permit extends
to NRC-initiated enforcement
proceedings and petitions for
enforcement action filed under § 2.206.
In addition, under §§ 52.39(a)(2)(i) and
(ii), the NRC grants finality to changes
to an early site permit’s emergency plan
(or major features of it, under
§ 52.17(b)(2)) that are made after the
issuance of the early site permit (1) if
the early site permit approved an
emergency plan (or major features
thereof) that is in use by a licensee of
a nuclear power plant and the changes
to the emergency plan (or major features
thereof) are identical to changes made to
the licensee’s emergency plans in
compliance with § 50.54(q); or (2) if the
early site permit approved an
emergency plan (or major features
thereof) that is not in use by a licensee
of a nuclear power plant, and the
changes are equivalent to those that
could be made under § 50.54(q) without
prior NRC approval had the emergency
plan been in use by a licensee. This
change is premised on the view that
changes to emergency plans which are
properly implemented under § 50.54(q)
do not require NRC review and approval
before implementation. Therefore, by
analogy, similar changes to an early site
permit’s emergency preparedness plan
made with similar controls, or changes
which are equivalent to those that could
be made under § 50.54(q) without prior
NRC approval, should not require NRC
review and approval as part of the
licensing process. Any issues related to
compliance with § 50.54(q) should be
treated as an enforcement matter. Note
that the NRC is making some
adjustments to this position in the final
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rule based on public comments. The
proposed rule would not have excepted
changes to early site permit emergency
plans not in use by a current licensee
that could be made under § 50.54(q)
without prior NRC approval had the
emergency plans been in use by a
licensee. The NRC is making this change
in the final rule because the § 50.54(q)
standard ensures adequate protection of
safety, and has been accepted and used
by the industry and NRC and it is
appropriate to apply this same standard
to changes in all emergency plans
approved by the NRC in the ESP
proceeding. The NRC is making similar
changes to § 52.79(b)(4) in the final rule
to require that all COL applicants
referencing early site permits with
complete and integrated emergency
plans or major features of emergency
plans identify changes that have been
incorporated into the proposed facility
emergency plans and that constitute or
would constitute a decrease in
effectiveness under § 50.54(q) of this
chapter.
Section 52.39(b) is discussed
separately under Section V.C.6.a of this
document, which discusses emergency
preparedness requirements for a
combined license applicant referencing
an early site permit.
Section 52.39(c) replaces the former
criteria in §§ 52.39(a)(2)(i) through (iii),
governing how the NRC will treat
various issues with respect to the early
site permit and its referencing in a
combined license application. Matters
regarding compliance with the early site
permit which would be potentially valid
subjects of a contention are listed in
§§ 52.39(c)(1)(i) through (iii), e.g.,
whether the reactor proposed to be built
under the referencing application fits
within the site characteristics and
design parameters specified in the early
site permit; whether one or more of the
terms and conditions of the early site
permit have been met; and whether a
variance requested by the referencing
applicant is unwarranted or should be
modified. The NRC notes that all
contentions at the early site permit
stage, including a contention pertaining
to a variance, must meet the
requirements for contentions in
§ 2.309(f). Matters regarding significant
new emergency preparedness or
environmental information material to
the combined license proceeding, which
would be potentially valid subjects of
contention under the proposed rule, are
listed in §§ 52.39(c)(1)(iv) and (v).
Other matters, including changes to
the site characteristics, design
parameters, or terms and conditions of
the early site permit, are treated under
§ 52.39(c)(2) as challenges to the permit
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and processed in accordance with
§ 2.206. The NRC is retaining the former
provision in § 52.39(a)(2)(iii) requiring
that the Commission consider a petition
filed under § 2.206, and determine
whether immediate action is required
before construction commences, as well
as the former provision indicating that
if a petition is granted, the Commission
will issue an appropriate order which
does not affect construction unless the
Commission makes its order
immediately effective.
The final rule redesignates the former
provision in § 52.39(b) allowing an
applicant for a license referencing an
early site permit to request a variance
from one or more ‘‘elements’’ of the
early site permit as § 52.39(d). The rule
clarifies ‘‘elements’’ for which a
variance may be sought by substituting
the phrase, ‘‘site characteristics, design
parameters, or terms and conditions of
the early site permit.’’ In addition, the
NRC is revising this provision further to
include an allowance for applicants to
request a variance from the site safety
analysis report (SSAR). The allowance
for requesting variances to the SSAR
was inadvertently omitted in the
proposed rule. Because the majority of
the early site permit information that a
combined license applicant will be
referencing will be the information in
the SSAR, it is logical that the
allowance to request variances be
extended to the information in the
SSAR given that the NRC is allowing
variances to the permit itself. The NRC
notes that the admission of a contention
on a proposed variance, which was
formerly addressed in § 52.39(b), is
addressed in § 52.39(c)(iii). The NRC is
also adding a provision that precludes
the Commission from issuing a variance
once a construction permit or combined
license referencing the early site permit
is issued. Any changes that would
otherwise require a variance should
instead be treated as an amendment to
the construction permit or combined
license.
Finally, the NRC is adding a new
paragraph to the ‘‘finality’’ section in
each subpart of part 52, in this instance
§ 52.39(f), entitled ‘‘Information
requests,’’ which delineates the
restrictions on the NRC for information
requests to the holder of the early site
permit. This provision is analogous to
the former provision on information
requests in paragraph 8 of appendix O
to parts 50 and 52, and is based upon
the language of § 50.54(f). For early site
permits, this provision is contained in
§ 52.39(d), and requires the NRC to
evaluate each information request on
the holder of an early site permit to
determine that the burden imposed by
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49379
the information request is justified in
light of the potential safety significance
of the issue to be addressed in the
information request. The only
exceptions would be for information
requests seeking to verify compliance
with the current licensing basis of the
early site permit. If the request is from
the NRC staff, the request would first
have to be approved by the Executive
Director for Operations (EDO) or his or
her designee.
7. Subpart B, Standard Design
Certifications
a. Section 52.41, Scope of Subpart
This section defines the scope of
subpart B of part 52. The requirements
on scope and type of nuclear power
plants that are eligible for design
certification were moved from former
§ 52.45(a) to this section, to ensure a
consistent format and presentation
among all the subparts of part 52.
b. Section 52.43, Relationship to Other
Subparts
This section defines the relationship
of subpart B to other subparts in 10 CFR
part 52. Conforming changes were made
to make clear that an application for a
manufacturing license may, but is not
required to, reference a design
certification rule (DCR). The
requirements formerly located in
§§ 52.43(c), 52.45(c), and 52.47(b)(2)(ii)
were removed because the Commission
decided not to require a final design
approval (FDA) under subpart E as a
prerequisite for certification of a
standard plant design. This requirement
was included in part 52, at the time of
the original rulemaking, because the
NRC had no experience with design
certifications. By requiring an FDA as a
prerequisite to design certification, the
NRC indicated that the licensing
processes for design certifications and
FDAs were similar, even though the
requirements for and finality of a design
certification differ from that of an FDA.
The NRC now has considerable
experience with design certification
reviews, and the former requirement to
apply for an FDA as part of an
application for design certification is no
longer needed. Future applicants have
the option to apply for either an FDA,
a design certification, or both.
c. Section 52.45, Filing of Applications
This section presents the
requirements for filing design
certification applications. This section
was reformatted for consistency with
the other subparts in part 52 and the
references to specific paragraphs within
§§ 50.4 and 50.30 were replaced with
references to subpart H of part 2. A new
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§ 52.45(c) on design certification review
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d. Section 52.46, Contents of
Applications; General Information
This section was added to set forth
general content requirements from 10
CFR 50.33.
e. Section 52.47, Contents of
Applications; Technical Information
This section presents the
requirements for contents of a design
certification application and is
organized into three sections. The
requirements for the final safety analysis
report (FSAR) are set forth in §§ 52.47(a)
and 52.47(c), and the technical
requirements for the remainder of the
design certification application are in
§ 52.47(b). The former § 52.47(a)(1)(i)
required the submittal of information
required for construction permits and
operating licenses by parts 20, 50
(including the applicable requirements
from 10 CFR 50.34), 73, and 100, which
were technically relevant to the design
and not site-specific. That general
requirement was removed and replaced
with specific requirements that describe
what must be included in an FSAR. In
addition, the NRC included technical
positions that were developed after part
52 was originally codified in 1989, e.g.,
§ 52.47(a)(22) which requires a
description of how relevant operating
experience was incorporated into the
standard design (see SRM on SECY–90–
377, dated February 15, 1991,
ML003707892). Also, the relevant
requirements were revised to clarify
their applicability to design
certifications and renumbered. This
effort resulted in a comprehensive list of
requirements for a design certification
application.
Some commenters recommended that
the requirement to demonstrate
technical qualifications [now
§ 52.47(a)(7)] be deleted because the
AEA only imposes that requirement on
applicants for a license. Although the
NRC agrees that the AEA imposes the
technical qualification finding
specifically for license applicants, it
does not preclude the NRC from a
determination that such a finding is also
necessary in other contexts. The
applicant creates information that may
become the bases for a future license
and, therefore, must be qualified to
perform design, analyses, and safety
determinations. Accordingly, the NRC
has concluded that a technical
qualification finding should also be
made for design certification applicants.
Some commenters recommended that
the requirement to address the standard
review plan (SRP) be revised to apply to
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light-water reactors. The NRC agrees
with this comment and has revised this
requirement [now § 52.47(a)(9)] to be
applicable to light-water-cooled nuclear
power plants, but notes that much of the
SRP review guidance and criteria are
general and would also apply to reviews
of gas-cooled reactor designs.
Some commenters recommended that
the requirement to provide information
required by § 50.49(d) [now
§ 52.47(a)(13)] be deleted because the
applicant will not be able to establish
qualification files for all applicable
components. The NRC agrees that
applicants may not be able to establish
qualification files, but applicants can
provide the electric equipment list
required by § 50.49(d). Therefore, the
NRC revised the wording in
§ 52.47(a)(13) to be consistent with the
wording for the same provision in
§ 52.79(a), which requires that
applicants provide the list of electrical
equipment important to safety required
by § 50.49(d).
Some commenters recommended that
the requirement in § 52.47(a)(22) to
demonstrate how operating experience
insights have been incorporated into the
plant design be deleted. The NRC
disagrees with this comment. The NRC
developed this requirement for future
plants (see SRM on SECY–90–377) and
it was implemented in past design
certification applications by addressing
NRC’s generic letters and bulletins. The
NRC agrees that insights from generic
letters and bulletins should be
incorporated into the latest revision of
the standard review plan (SRP).
Therefore, for plant designs that are
based on or are evolutions of nuclear
plants that have operated in the United
States, the applicant should use NRC’s
generic letters and bulletins issued after
the most recent revision of the
applicable SRP and 6 months before the
docket date of the application. If the
application is for a nuclear plant design
that is not based on or is not an
evolution of a nuclear plant that
operated in the United States, the
applicant should address how insights
from any relevant international
operating experience has been
incorporated into that plant design.
Some commenters recommended that
the requirement to describe severe
accident design features in the FSAR
[now § 52.47(a)(23)] be deleted. The
NRC disagrees with this comment
because the Commission has
determined that this requirement is
necessary for future light-water reactor
designs (see SRM on SECY–93–087) and
was applied to previous applications.
The commenters confused the meaning
of design bases information (see § 50.2)
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with the requirements for design-basis
accidents (DBAs). Postulated severe
accidents are not design-basis accidents
and the severe accident design features
do not have to meet the requirements for
DBAs (see SECY–93–087). However, the
severe accident design features are part
of a plant’s design bases information.
A new § 52.47(b) was created to set
forth the required technical contents of
a design certification application that
are not required to be located in the
FSAR. In response to public comments
on the proposed rule, the NRC has
deleted proposed § 52.47(b)(1) which
required design certification applicants
to submit a design-specific probabilistic
risk assessment (PRA). In its place, the
NRC has added new § 52.47(a)(27)
which requires that design certification
applicants submit a description of the
design-specific PRA and its results in
the FSAR. The NRC agrees with some
commenters that applicants should not
be required to submit their complete
design-specific PRA and that, instead,
applicants should only be required to
provide a summary description of the
PRA and its results in their FSAR with
the understanding that the complete
PRA (e.g., codes) would be available for
NRC inspection at the applicant’s
offices, if needed. The NRC expects that,
generally, the information that it needs
to perform its review of the design
certification application from a PRA
perspective is that information that will
be contained in applicants’ FSAR
Chapter 19.
The rule language for ITAAC [now
§ 52.47(b)(1)] was conformed with the
statutory language in the AEA. This
clarification of the language in the
former § 52.47(a)(1)(vi), which was a
condensed version of the language in
the former § 52.97(b)(1), was intended to
avoid any misunderstandings regarding
the statutory requirement. Some
commenters recommended that the rule
language in § 52.47(b)(1) be modified to
maintain the language in the former
§ 52.47(a)(1)(vi) claiming the proposed
language could be misconstrued as
expanding the scope of ITAAC needed
for design certification. The NRC
disagrees with this comment and notes
that it is well understood that the
requirements that are applicable to
design certification are limited to the
scope of the certified design.
Some commenters recommended that
the requirement in proposed
§ 52.47(b)(3) (now in 10 CFR 51.55) to
evaluate severe accident mitigation
design alternatives (SAMDAs) be
deleted and that the NRC should initiate
a rulemaking or policy statement to
disposition SAMDA generically. The
NRC disagrees with this comment. The
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NRC has required SAMDA evaluations
for previous applications in order to
achieve greater finality for the design
features that are resolved in design
certification rulemakings. Further, the
initiation of a rulemaking or policy
statement for SAMDAs is outside the
scope of the part 52 update rulemaking.
As for the perspective that SAMDA
evaluations need not be performed for
current reactor designs because the
severe accident risk for such designs is
too remote and speculative, the NRC has
already addressed this issue in other
contexts. The NRC has considered
petitions to eliminate the consideration
of SAMDAs previously. The NRC
position, both then and now is that it is
not prepared to reach the conclusion
that the risks of all severe accidents are
so unlikely as to warrant their
elimination from consideration in our
NEPA reviews. As the NRC has stated in
response to other requests to confine or
eliminate such issues from
consideration, if new information in the
future provides a firm basis for
concluding that severe accidents are
remote and speculative, then the NRC
may revisit the issue.
Former § 52.47(b) was reorganized by
separating the requirements on scope of
design and modular configuration [now
located in § 52.47(c)] from the testing
requirements. This action is part of the
NRC’s goal to put the procedural
requirements for the licensing processes
in part 52 and maintain the reactor
safety requirements in part 50 (or other
parts of 10 CFR Chapter I. As a result,
the testing requirements were relocated
to § 50.43(e). Also, see the discussion on
testing for advanced nuclear reactors in
Section V.B of this document.
f. Section 52.54, Issuance of Standard
Design Certification
This section was amended to be
consistent with the parallel provisions
in §§ 50.50 and 50.57 by including
requirements that, after conducting a
rulemaking proceeding and receiving
the report submitted by the ACRS, the
NRC will determine whether there is
reasonable assurance that the design
conforms with the provisions of the
AEA, and the NRC’s regulations; that
the applicant is technically qualified;
and that issuance of the design
certification will not be inimical to the
common defense and security or to the
health and safety of the public. In
addition, a new § 52.54(a)(8) was added
to state that the NRC will not issue a
design certification unless it finds that
the design certification applicant has
implemented the quality assurance
program described in the safety analysis
report. This requirement was added to
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indicate the NRC’s expectation that
design certification applicants will
implement the QA program that is
required to be included in their
application under § 52.47(a)(19), which
is consistent with the requirement for
licensees.
A new § 52.54(b) was added to require
that a design certification specify the
site parameters and design
characteristics and any additional
requirements and restrictions of the
rule, as the Commission deems
necessary and appropriate. Some
commenters recommended that the
requirement in § 52.54(b) to list ‘‘design
characteristics’’ be removed and noted
that the design control document will
contain this information. The NRC
disagrees with this comment. The NRC
wants to specifically identify this
information to facilitate future
comparisons with ‘‘design parameters’’
specified in an early site permit. The
NRC staff will use its experience with
current early site permit reviews to
determine what an appropriate list will
be for future design certification
reviews.
The NRC also modified § 52.54 to
require that applicants for a design
certification agree to withhold access to
National Security Information from
individuals until the requirements of 10
CFR parts 25 and/or 95, as applicable,
are met. Section 52.54 was amended to
include a new paragraph (c) which
requires that every DCR contain a
provision stating that, after the
Commission has adopted the final
design certification rule, the applicant
for that design certification will not
permit any individual to have access to,
or any facility to possess, Restricted
Data or classified National Security
Information until the individual and/or
facility has been approved for access
under the provisions of 10 CFR parts 25
and/or 95. The NRC believes that this
amendment, along with the changes to
parts 25, 95, and 10 CFR 50.37, are
necessary to ensure that access to
classified information is adequately
controlled by all entities applying for
NRC certifications.
g. Section 52.63, Finality of Standard
Design Certifications
The final rule revises the finality
provisions in § 52.63(a) to provide
processes for amending design
certification information without
meeting the special backfit requirement
in § 52.63(a)(1)(ii). The special backfit
requirement restricted changes to
certification information, thereby
ensuring that all plants built under a
referenced certified design would be
standardized. Section 52.63(a)(1) was
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also revised to replace ‘‘a modification’’
with ‘‘the change,’’ to clarify that the
criteria for changes apply to
modifications, rescissions, or imposition
of new requirements. In addition,
§ 52.63 was revised to use the phrase
‘‘certification information’’ in order to
distinguish the rule language in the
DCRs from the design certification
information (e.g., Tier 1 and Tier 2
information) that is incorporated by
reference in the DCRs.
Section 52.63(a)(1)(iii) was added to
provide the NRC with the ability to
make generic changes to the design
certification rule language that reduce
unnecessary regulatory burdens. The
former § 52.63(a)(1) stated that the
Commission may not modify, rescind,
or impose new requirements on the
certification unless the change is: (1)
Necessary for compliance with
Commission regulations applicable and
in effect at the time the certification was
issued; or (2) necessary to provide
adequate protection of the public health
and safety or common defense and
security. This requirement did not
appear to permit changes to the rule
language which reduce unnecessary
regulatory burdens in circumstances
where the change continues to maintain
protection to public health and safety
and common defense and security. An
example of a change which could not be
made under the former § 52.63(a)(1) was
a change to the rule language in
appendices A, B, and C of part 52, to
incorporate into the Tier 2 change
process the revised change criteria in 10
CFR 50.59. Section 50.59 was revised in
1999 to provide new criteria for, inter
alia, making changes to a facility, as
described in the final safety analysis
report, without prior NRC approval, to
reduce unnecessary regulatory burden
(64 FR 53582, October 4, 1999).
In Section V of the 2006 proposed
rule, Question 14, the NRC stated that
it was considering adopting an
additional provision in § 52.63(a)(1) that
would allow amendments of DCRs to
incorporate generic resolutions of
design acceptance criteria (DAC) or
other design information without
meeting the special backfit requirement
in the former § 52.63(a)(1). By allowing
for an amendment to generically resolve
DAC, the NRC would achieve resolution
of additional design issues, would
achieve finality for those issue
resolutions, and would avoid repetitive
consideration of those design issues in
individual combined license
proceedings. The final rule includes an
amendment process in § 52.63(a)(1)(iv)
that allows for generic resolutions of
DAC without meeting the special backfit
requirement. These amendments will
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apply to all plants that have or will
reference the DCR under § 52.63(a)(2).
The NRC believes that these
amendments will enhance
standardization by further completing
the certification information. The NRC
will review the amendment application
to ensure that the design acceptance
criteria are met and that the new design
information conforms with the
applicable regulations.
Some commenters proposed that the
amendment process should allow for
generic resolutions of errors in the
certification information. The NRC is
aware that design certification
applicants have discovered errors in
their design information after the NRC
has completed its review and even after
the NRC has certified their design. The
final rule includes a new provision in
§ 52.63(a)(1)(v) to correct material errors
in the certification information. This
provision is only to be used to correct
a material error, which is an error that
significantly and adversely affects a
design function or analysis conclusion
described in the design control
document (certification information).
The NRC wants to correct material
errors by amendment so that these
errors will not have to be addressed in
individual licensing proceedings.
Many commenters encouraged the
NRC to adopt an amendment process
that would allow for ‘‘beneficial’’
changes to certification information,
would apply the amendment to all
plants referencing the certified design,
and would only allow amendments
prior to issuance of the first combined
license that referenced the DCR. The
NRC agreed with these comments and
included paragraph (a)(1)(vi) to allow
for amendments of certification
information that will substantially
increase the overall safety, reliability, or
security of facility design, construction,
or operation provided that the direct
and indirect costs of implementation of
the amendment are justified in view of
this increased safety, reliability, or
security. However, the NRC does not
agree with precluding amendments after
issuance of the first combined license. If
licensees who referenced a DCR want to
adopt a proposed amendment in order
to achieve enhanced standardization
and the beneficial changes that the
amendment would bring, then the NRC
may amend the DCR and apply the
amendment to all plants referencing the
DCR.
Also, some commenters requested
that the amendment process allow for
changes to the certification information
for a wide variety of other reasons.
These commenters claimed that the
need for a design change may be
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discovered during detailed design work
performed after the original design
information was approved by the NRC
(so-called first-of-a-kind-engineering) or
that certain components in the original
design may no longer be available for
purchase due to the long duration of a
DCR. The NRC’s deliberations on this
proposal considered the Commission’s
goal for design certification, which is to
achieve and maintain the benefits of
standardization. The NRC is still
determined to maintain standardization,
but has decided to allow amendments
for other design changes [see paragraph
(a)(1)(vii)] provided that the amendment
will be applied to all plants that
reference the DCR, thereby increasing
standardization. In determining whether
to codify a proposed amendment, the
NRC will give special consideration to
comments from applicants or licensees
who reference the DCR regarding
whether they want to backfit their
plants with these additional design
changes.
The final rule includes a new
§ 52.63(a)(2), which sets forth
procedures for rulemakings conducted
under § 52.63(a)(1). Paragraph (a)(2)(i)
requires that for rulemakings under
§ 52.63(a)(1), except for rulemakings
under § 52.63(a)(1)(ii) necessary to
provide adequate protection, the NRC
will give consideration to whether the
benefits justify the costs for plants that
are already licensed or for which an
application for a license is under
consideration.
The final rule also revised the former
§ 52.63(a)(2) [now § 52.63(a)(3)] to delete
the reference to the former § 52.63(a)(4)
[now § 52.63(a)(5)]. The reference to the
former § 52.63(a)(4) was in error because
this paragraph discusses the finality of
the findings required for issuance of a
combined license or operating license,
whereas the new § 52.63(a)(3) deals with
modifications that the NRC may impose
on a DCR under §§ 52.63(a)(4) or
52.63(b)(1). No substantive change is
intended by this revision, which merely
clarifies the intent of the rule.
Finally, the NRC restates its previous
decision regarding the ability of any
person to request an amendment to a
DCR. In Section II.1.h of the 1989 SOC
for part 52 (54 FR 15372), the
Commission stated that § 52.63(a)(1)
places a designer on the same footing as
the NRC or any other interested member
of the public. Therefore, anyone may
submit a petition for rulemaking to the
NRC to correct an error or otherwise
amend the certification information. All
amendments to the certification
information must be accomplished
through rulemaking, with an
opportunity for public comment under
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§ 52.63(a)(2). Once a certified design is
amended by rulemaking, the new rule
would apply to all applications
referencing the DCR as well as all plants
referencing the DCR, unless the change
has been rendered ‘‘technically
irrelevant’’ through other action taken
under §§ 52.63(a)(4) or (b)(1). Also, the
NRC will decide whether to codify the
proposed amendment based on
comments from the referencing
applicants and licensees. Thus,
standardization is maintained by
ensuring that any generic change to the
certification information is imposed
upon all nuclear power plants
referencing the DCR. The duration of the
amended DCR will be for the same
period of time as the original DCR and
have the same expiration date.
8. Subpart C, Combined Licenses
a. Emergency Preparedness
Requirements for a Combined License
Applicant Referencing an Early Site
Permit
The NRC is revising former §§ 52.39
and 52.79 to require a license applicant
referencing an early site permit to
update and correct the emergency
preparedness information provided
under § 52.17(b). The issue of updating
an early site permit was first raised by
the Illinois Department of Nuclear
Safety, who suggested in a September
28, 1994, letter that emergency plans
and/or offsite certifications approved as
part of an early site permit review be
kept up-to-date throughout the duration
of an early site permit and the
construction phase of a combined
license.
In SECY–95–090, ‘‘Emergency
Planning Under 10 CFR Part 52’’ (April
11, 1995), the NRC staff stated that 10
CFR part 52 does not clearly require an
applicant referencing an early site
permit to submit updated information
on changes in emergency preparedness
information or in any emergency plans
that were approved as part of the early
site permit in accordance with § 52.18.
SECY–95–090 indicated (p. 4) that, in
view of the lack of industry interest in
pursuing an early site permit, resolution
of this matter could be deferred until a
‘‘lessons learned’’ rulemaking, updating
10 CFR part 52, was conducted after the
first design certification rulemakings
were issued. Following public release of
a draft SECY paper setting forth the NRC
staff’s preliminary views on the
licensing process for a combined
license, NEI submitted a letter dated
September 8, 1998 (comment 2.d),
which expressed opposition to a
requirement for updating emergency
preparedness information throughout
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the duration of an early site permit,
absent an application referencing the
early site permit. As an alternative to
updating throughout the duration of an
early site permit, NEI proposed that
emergency planning information be
updated when an application for a
license referencing the early site permit
is filed; portions of the emergency plans
that are unchanged would continue to
have finality under 10 CFR 52.39. In a
September 3, 1999 letter, the NRC staff
identified updating of emergency
preparedness information in early site
permits as a possible subject for the part
52 rulemaking.
The NRC agrees in part with the
Illinois Department of Nuclear Safety.
Emergency plans and/or offsite
certificates in support of emergency
plans, approved as part of an early site
permit review, should be updated.
However, emergency plans do not need
to be kept up-to-date throughout the
duration of an early site permit. There
is no need to update the emergency
plans approved in an early site permit
until the time the permit is referenced
in a combined license application. At
that time, the emergency plans would
have to be reviewed to confirm that they
are up-to-date and to provide any new
information that may materially affect
the NRC’s earlier determination on
emergency preparedness, or correct
inaccuracies in the emergency
preparedness information approved in
the early site permit in support of a
reasonable assurance determination, in
accordance with § 50.47 and appendix E
to part 50. In addition, the NRC agrees
with NEI that a ‘‘continuous’’ early site
permit update requirement would
impose burdens upon the early site
permit holder without any
commensurate benefit if the early site
permit is not subsequently referenced.
Accordingly, the Commission has
determined that §§ 52.39 and 52.79
should contain an updating requirement
to be imposed upon the applicant
referencing an early site permit.
A new § 52.39(b) is added to require
an applicant for a construction permit,
operating license, or combined license,
whose application references an early
site permit, to update and correct the
emergency preparedness information
provided under § 52.17(b). In addition,
the applicant must discuss whether the
new information could materially
change the bases for compliance with
the applicable NRC requirements. A
parallel requirement is included in
§ 52.79 to ensure that applicants for
combined licenses referencing an early
site permit will submit the updated
emergency preparedness information.
Section 52.39(a)(1)(iii) is also added
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stating that the Commission may modify
an early site permit if it determines that
a modification is necessary based on
updated emergency preparedness
information provided in a referencing
license application. New information
that materially changes the bases for
compliance includes information that
substantially alters the bases for a
previous NRC conclusion with respect
to the acceptability of a material aspect
of emergency preparedness or an
emergency preparedness plan, and
information that would constitute a
basis for the Commission to modify or
impose new terms and conditions on
the early site permit related to
emergency preparedness in accordance
with § 52.39(a)(1). New information that
materially changes the NRC’s
determination of the matters in
§ 52.17(b), or results in modifications of
existing terms and conditions under
§ 52.39(a)(1) will be subject to litigation
during the construction permit,
operating license, or combined license
proceedings in accordance with
§ 52.39(c).
Not all new information on
emergency preparedness will be subject
to challenge in a hearing under
§ 52.39(c). For example, an emergency
plan may have to be updated to reflect
current telephone numbers, names of
governmental officials whose positions
and responsibilities are defined in the
plan (e.g., the name of the current police
chief for a municipality), or current
names of hospital facilities. These
corrections do not materially change the
NRC’s previously-stated bases for
accepting the early site permit
emergency plan, and a hearing
contention will not be admitted under
§ 52.39(c) in a proceeding for a license
referencing the early site permit. In
contrast, if an emergency plan
submitted as part of an early site permit
relies upon a bridge to provide the
primary path of evacuation, and that
bridge no longer exists, the change
could materially affect the NRC’s
previous determination that the
emergency plan complied with the
Commission’s emergency preparedness
regulations in effect at the time of the
issuance of the early site permit. This
type of information might be the basis
for a change in the early site permit’s
terms and conditions related to
emergency preparedness under
§ 52.39(a)(1), as well as the basis for a
hearing contention under § 52.39(c),
assuming that the requirements in 10
CFR part 2 for admission of a contention
are met.
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b. Resolution of ITAAC
Sections 52.99 and 52.103 are revised
to incorporate rule language from the
design certification regulations in 10
CFR part 52 regarding the completion of
ITAAC (see paragraphs IX.A and IX.B.3
of appendix A to part 52). During the
preparation of the design certification
rules for the ABWR and System 80+
designs, the NRC staff and nuclear
industry representatives agreed on
certain requirements for the
performance and completion of the
inspections, tests, or analyses in ITAAC.
In the design certification rulemakings,
the NRC codified these ITAAC
requirements into Section IX of the
regulations. The purpose of the
requirement in § 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 has been met.
Section 52.99(c) requires the licensee
to notify the NRC that the prescribed
inspections, tests, and analyses in the
ITAAC have been or will be completed
and that the acceptance criteria have
been met. The NRC is revising
§ 52.99(c)(1) in the final rule to more
closely follow the language of Section
185b. of the AEA (in response to a latefiled comment) and to clarify that the
notification must contain sufficient
information to demonstrate that the
prescribed inspections, tests, and
analyses have been performed and that
the prescribed acceptance criteria have
been met. The NRC is adding this
clarification to ensure that combined
license applicants and holders are aware
that (1) it is the licensees’ burden to
demonstrate compliance with the
ITAAC and (2) the NRC expects the
notification of ITAAC completion to
contain more information than just a
simple statement that the licensee
believes the ITAAC has been completed
and the acceptance criteria met. The
NRC expects 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 have been 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 have been
performed and that the prescribed
acceptance criteria have been met. The
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NRC plans to prepare regulatory
guidance, in consultation with
interested stakeholders, to explain how
the functional requirement to provide
‘‘sufficient information’’ with regard to
ITAAC submittals could be met.
The NRC is also revising § 52.99(c) in
the final rule by adding a new paragraph
(c)(2) requiring 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 Section 189.a(1)(B) requirement
governing a request for hearing on
acceptance criteria, and the Section
185.b. requirement that the Commission
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. It is the licensee’s burden to
demonstrate that it will comply with the
ITAAC and it 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. 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 have been met.
Paragraph (e) has been revised to
require that the NRC make available to
the public the notifications to be
submitted under § 52.99(c)(1) and (c)(2),
no later than the Federal Register notice
of intended operation and opportunity
for hearing on ITAAC under § 52.103(a).
A conforming change is included in
§ 2.105(b)(3) to require that the
§ 52.103(a) notice reference the public
availability of the § 52.99(c)(1) and (2)
notifications. The NRC is requiring that
the paragraph (c)(2) notification be
made 225 days before the date
scheduled for initial loading of fuel, in
order to ensure that the licensee
notifications are publicly available
through the NRC document room and
online through the NRC Web site at the
same time that the § 52.103(a) notice is
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published in the Federal Register. The
NRC’s goal is to publish that notice 210
days before the date scheduled for fuel
loading, but in all cases the § 52.103(a)
notice would be published no later than
180 days before the scheduled fuel load,
as required by Section 189.a(1)(B) of the
AEA.
In Section V of the Supplementary
Information of the proposed rule, the
NRC requested stakeholder feedback on
whether a provision on completion of
ITAAC in a set time period prior to fuel
load should be added to the final rule.
Commenters did not support addition of
a requirement on completion of ITAAC
in a set time period prior to fuel load
and the NRC has not included a
provision requiring the completion of
all ITAAC by a certain time prior to the
licensee’s scheduled fuel load date.
Instead, the NRC has decided to modify
the concept slightly by requiring the
licensee to submit, with respect to
ITAAC which have not yet been
completed 225 days before the
scheduled date for initial loading of
fuel, additional information addressing
whether those inspections, tests, and
analyses will be successfully completed
and the acceptance criteria met before
initial operation. In the case where the
licensee has not completed all ITAAC
by 225 days prior to its scheduled fuel
load date, the NRC expects the
information that the licensee submits
related to uncompleted ITAAC to be
sufficiently detailed such that the NRC
can determine what activities it will
need to undertake to determine if the
acceptance criteria for each of the
uncompleted ITAAC have been met,
once the licensee notifies the NRC that
those ITAAC have been successfully
completed and their acceptance criteria
met. In addition, the NRC is adopting
the requirements in paragraphs (c)(1)
and (c)(2) to ensure that interested
persons will be able to meet the Atomic
Energy Act, Section 189.a(1), threshold
for requesting a hearing with respect to
both completed and as-yet uncompleted
ITAAC. The NRC therefore expects that
the information submitted by licensees
in the § 52.99(c)(2) notification will be
sufficiently complete and detailed.
Furthermore, the NRC expects that any
contentions submitted by prospective
intervenors regarding uncompleted
ITAAC would focus on the inadequacies
of the procedures and analytical
methods described by the licensee for
completing those ITAAC in the context
of the reasonable assurance finding
under § 52.103(b)(2). Therefore, the
level of detail provided by the licensee
should be sufficient to allow a
prospective intervenor to form such
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judgments by reference to that
information. The NRC plans to prepare
regulatory guidance providing further
explanation of what constitutes
‘‘sufficient information’’ to demonstrate
that the inspections, tests, or analyses
for uncompleted ITAAC will be
successfully completed and the
acceptance criteria for the uncompleted
ITAAC will be 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 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 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 § 52.103(g).
Therefore, licensees should structure
their construction schedules to take into
account these time periods. The NRC
intends to develop regulatory guidance
on the licensee’s completion and NRC
verification of ITAAC and will provide
estimates of the time it expects to take
to verify successful completion of
various types of ITAAC. The NRC
expects that such guidance, along with
frequent communication with licensees
during construction, will provide
licensees with adequate information to
plan initial fuel loading and related
activities.
Section 52.99(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 have
not been met. The NRC is revising
§ 52.99(d) in the final rule as a result of
comments made on the proposed rule.
Proposed § 52.99(d) stated that, in the
event that an activity is subject to an
ITAAC derived from a referenced early
site permit or 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, request a variance from the
early site permit ITAAC, or request an
exemption from the standard design
certification ITAAC, as applicable. The
language in proposed § 52.99(d) that
referred to requesting variances to ESP
ITAAC after the COL is issued is
inconsistent with rule language in other
sections of proposed part 52 (e.g.,
§ 52.39(d)). Therefore, the NRC has
adopted the commenters’ suggestion to
delete references to ESP ITAAC and ESP
variances from § 52.99(d).
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Paragraph (e)(1) requires the NRC to
publish, at appropriate intervals until
the last date for submission of requests
for hearing under § 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
paragraphs (c)(1) and (c)(2). In general,
the NRC expects to make the paragraph
(c)(1) notifications availability shortly
after the NRC has received the
notifications and concluded that they
are complete and detailed. Furthermore,
by the date of the Federal Register
notice of intended operation and
opportunity to request a hearing on
whether acceptance criteria have been
or will be met (under § 52.103(a)), the
NRC will make available the
notifications under paragraph (c)(2), and
the notifications under paragraph (c)(2)
for all ITAAC for which paragraph (c)(1)
notifications have not been provided by
the licensee.
Finally, § 52.103(h) states that ITAAC
do not, by virtue of their inclusion in
the combined license, constitute
regulatory requirements after the
licensee has received authorization to
load fuel or for renewal of the license.
However, subsequent modifications
must comply with the design
descriptions in the design control
document unless the applicable
requirements in the § 52.97 (proposed
§ 52.98) and Section VIII of the design
certification rules have been complied
with.
In a letter dated April 3, 2001
(comment 23), NEI requested that the
NRC ‘‘consider incorporating DCR
[Design Certification Rule] general
provisions into Subpart C as
appropriate.’’ The NRC has added these
ITAAC requirements to § 52.99,
consistent with NEI’s proposal, because
it believes that these provisions embody
general principles that are applicable to
all holders of combined licenses.
The NRC revised § 52.99 in the final
rule to delete the requirements in
proposed § 52.99(a). Proposed § 52.99(a)
required holders of COLs to comply
with the provisions of §§ 50.70 and
50.71. Because the language in proposed
§§ 50.70 and 50.71 requires COL holders
to comply with their provisions, and
because of the applicability provisions
in § 52.0(b), this duplicate requirement
in § 52.99 is unnecessary.
The NRC has added a new paragraph
(a) in § 52.99 that requires a licensee to
submit to the NRC, no later than 1 year
after issuance of the combined license
or at the start of construction as defined
in 10 CFR 50.10, whichever is later, its
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schedule for completing the inspections,
tests, or analyses in the ITAAC.
Licensees are required 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 § 52.99(c). In Section V of
the Supplementary Information of the
2006 proposed rule, the NRC requested
stakeholder feedback on whether such a
provision should be added to the final
rule. Although some commenters did
not believe that a regulatory
requirement for submission of a
schedule was necessary, the NRC
believes it is necessary to ensure the
NRC has sufficient information to plan
all of the activities necessary for the
NRC to support the Commission’s
finding whether all of the ITAAC have
been met prior to the licensee’s
scheduled date for fuel load.
c. Section 52.73, Relationship to Other
Subparts
Section 52.73 clarifies that a design
approval issued under subpart E of part
52 or a manufacturing license under
subpart F of part 52 may also be
referenced in an application for a
combined license filed under 10 CFR
part 52. The former § 52.73 only stated
that a combined license may reference
a standard design certification or an
early site permit. The final rule
incorporates into new § 52.73(b) the
requirement in the current § 52.63(c) in
order to clarify that this requirement
applies to applicants for a combined
license. This provision requires that,
before granting a combined license
which references a standard design
certification, information normally
contained in certain procurement
specifications and construction and
installation specifications be completed
and available for audit if the
information is necessary for the NRC to
make its safety determinations,
including the determination that the
application is consistent with the
certified design. No substantive change
is intended by the restatement of this
requirement. In a letter dated April 3,
2001 (comments 3 and 3.a), NEI agreed
with the proposed change but
recommended that the last sentence of
§ 52.63(c) be deleted and the remaining
provision be added to the former § 52.79
rather than the former § 52.73. The NRC
agrees with NEI that 10 CFR part 52
should be modified to clarify that the
requirement in former § 52.63(c) applied
to applicants for a combined license,
and that the last sentence be deleted.
However, the Commission is adding the
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49385
remaining provision to the original
§ 52.73(b), and not to § 52.79, as
recommended by NEI.
d. Section 52.75, Filing of Applications
Section 52.75 provides requirements
for the filing of combined license
applications. The NRC has reformatted
this section for consistency with the
other subparts in 10 CFR part 52 and to
replace the references to specific
paragraphs within §§ 50.4 and 50.30
with general references to those
sections. The specific references are no
longer needed because the NRC is
adopting conforming changes to §§ 50.4
and 50.30 in this final rule which clarify
which provisions are applicable to
combined license applications.
e. Section 52.78, Content of
Applications; Training and
Qualification of Nuclear Power Plant
Personnel
Section 52.78 has been removed, and
the requirements applicable to an
applicant for, and holder of, a combined
license with respect to the training
program are moved to § 50.120, where
the requirements currently exist for
holders of operating licenses.
f. Section 52.79, Contents of
Applications; Technical Information in
Final Safety Analysis Report; and
§ 52.80, Contents of Application;
Additional Technical Information
Section 52.79 is reformatted to divide
the requirements for the technical
contents of a combined license
application into two separate
provisions. Section 52.79 covers
requirements for the contents of the
FSAR, and § 52.80 covers requirements
for the remainder of the technical
content of a combined license
application.
Former § 52.79 states that a combined
license application must contain the
technically relevant information
required of applicants for an operating
license by 10 CFR 50.34. The reference
to 10 CFR 50.34 is removed and
replaced with § 52.79(a), which contains
all of the relevant requirements from 10
CFR 50.34 that describe what must be
included in the FSAR for a combined
license application, including
requirements that are currently
applicable to both construction permit
and operating license applications. In
addition, requirements from other
sections of 10 CFR part 50 (e.g., §§ 50.48
and 50.63) are included. These
requirements were issued after the
current fleet of operating reactors were
licensed and, therefore, were not
required contents for these earlier
FSARs. In making these modifications,
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the NRC has attempted to capture all
relevant requirements regarding
contents of the FSAR for a combined
license application.
In addition, § 52.79(a) contains
requirements for descriptions of
operational programs that need to be
included in the FSAR to allow a
reasonable assurance finding of
acceptability. This amendment is in
support of the Commission’s direction
to the staff in SRM–SECY–02–0067
dated September 11, 2002, ‘‘Inspections,
Tests, Analyses, and Acceptance
Criteria for Operational Programs
(Programmatic ITAAC),’’ that a
combined license applicant was not
required to have ITAAC for operational
programs if the applicant fully
described the operational program and
its implementation in the combined
license application. In this SRM, the
Commission stated:
[a]n ITAAC for a program should not be
necessary if the program and its
implementation are fully described in the
application and found to be acceptable by the
NRC at the COL stage. The burden is on the
applicant to provide the necessary and
sufficient programmatic information for
approval of the COL without ITAAC.
The Commission clarified its
definition of fully described in SRM–
SECY–04–0032, ‘‘Programmatic
Information Needed for Approval of a
Combined License Application Without
Inspections, Tests, Analyses, and
Acceptance Criteria,’’ dated May 14,
2004, as follows:
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In this context, fully described should be
understood to mean that the program is
clearly and sufficiently described in terms of
the scope and level of detail to allow a
reasonable assurance finding of acceptability.
Required programs should always be
described at a functional level and at an
increased level of detail where
implementation choices could materially and
negatively affect the program effectiveness
and acceptability.
Accordingly, the NRC is adding
requirements for descriptions of
operational programs. In doing so, the
NRC has taken into account NEI’s
proposal to address SRM–SECY–04–
0032 in its letter dated August 31, 2005
(ML052510037). That proposal was
reflected in SECY–05–0197 (October 28,
2005, ML052770225), Attachment 1,
and approved by the Commission in
SRM–SECY–05–0197 dated February
22, 2006 (ML060530316). During the
preparation of the final rule, the NRC
discovered that several of the
operational programs listed in SECY–
05–0197 were not addressed in
proposed § 52.79. To ensure the list of
requirements for the contents of
applications is complete, the NRC is
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adding several new provisions to
address operational programs in the
final rule. Specifically, the NRC is
adding requirements to § 52.79 for COL
applicants to include a description of:
(1) The process and effluent monitoring
and sampling program required by
appendix I to 10 CFR part 50
[§ 52.79(a)(16)(ii)]; (2) a training and
qualification plan in accordance with
the criteria set forth in appendix B to 10
CFR part 73 [§ 52.79(a)(36)(ii)]; (3) a
description of the radiation protection
program required by § 20.1101
[§ 52.79(a)(39)]; (4) a description of the
fire protection program required by
§ 50.48 [§ 52.79(a)(40)]; and (5) a
description of the fitness-for-duty
program required by 10 CFR part 26
[§ 52.79(a)(44)]. During the preparation
of the final rule, the NRC also noticed
that the proposed rule had not
completely implemented the
Commission’s direction regarding the
treatment of operational programs in a
COL application inasmuch as
requirements to address operational
program implementation were not
included in proposed § 52.79(a).
Therefore, in the final rule, the NRC has
added requirements to address the
implementation of all operational
programs required to be described in a
COL application. This is consistent with
the Commission’s position in SRM–
SECY–02–0067 that a combined license
applicant is not required to have ITAAC
for operational programs if the applicant
‘‘fully describes the operational program
and its implementation’’ in the
combined license application [emphasis
added].
In addition, the NRC added a new
provision to § 52.79(a) in the final rule
to address the application requirements
in current § 20.1406. Section 20.1406
requires applicants for a license to
describe in their application how
facility design and procedures for
operation will minimize, to the extent
practicable, contamination of the facility
and the environment, facilitate eventual
decommissioning, and minimize, to the
extent practicable, the generation of
radioactive waste. To ensure that § 52.79
contains a complete list of the
requirements for the contents of a COL
application, the NRC added paragraph
(a)(45) to § 52.79 to require COL
applications to include the information
required by § 20.1406. This is not a new
requirement but merely a pointer to an
existing requirement to include this
information.
Section 52.79(a) requires that
emergency plans submitted with a
combined license application be
included in the FSAR. This
modification from the former rule is
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being made for consistency with § 50.34
which requires that emergency plans be
included in the FSAR for operating
license applications.
The NRC is adding a new provision in
§ 52.79(a)(29)(ii) that the applicant
submit plans for coping with
emergencies, other than the plans
required by § 52.79(a)(21). Paragraph
52.79(a)(21) requires the applicant to
submit emergency plans complying
with the requirements of § 50.47 and 10
CFR part 50, appendix E. This
requirement was drawn from the
existing requirement in § 50.34(b)(6)(v)
which requires applicants to submit
‘‘Plans for coping with emergencies,
which shall include the items specified
in appendix E.’’ When this requirement
was translated into the associated
requirement for combined license
applicants, the NRC inadvertently only
included a portion of the requirements
in § 50.34(b)(6)(v), namely, the
requirement in proposed § 52.79(a)(21)
to submit emergency plans. The NRC
has corrected this omission in the final
rule by including the new provision in
§ 52.79(a)(29)(ii) to include other plans
for coping with emergencies. This
requirement is meant to capture, for
example, emergency operating
procedures as discussed in SRP Section
13.5.2.1, ‘‘Operating and Emergency
Operating Procedures.’’
The NRC has moved the requirements
contained in proposed § 52.79(a)(23)
that addressed a request to conduct
activities under § 50.10(e) and added
them in a new § 52.80(c). The NRC
concluded that it is preferable to
include both the list of proposed
§ 50.10(e) activities and the redress plan
as separate documents in the
application, outside of both the site
safety analysis report and the
environmental report. The NRC’s
conclusion is based on the fact that the
requirements in § 50.10(e) address both
safety and environmental issues.
Additional changes were made to
§§ 51.50 and 52.17 to implement this
concept.
Some commenters recommended that
the requirement in § 52.79(a)(37) to
demonstrate how operating experience
insights have been incorporated into the
plant design be deleted. The NRC
disagrees with this comment. The NRC
developed this requirement for future
plants (see SRM on SECY–90–377) and
it was implemented in past design
certification applications by addressing
NRC’s generic letters and bulletins. The
NRC agrees that insights from generic
letters and bulletins should be
incorporated into the latest revision of
the standard review plan (SRP).
Therefore, for plant designs that are
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based on or are evolutions of nuclear
plants that have operated in the United
States, the applicant should use NRC’s
generic letters and bulletins issued after
the most recent revision of the
applicable SRP and 6 months before the
docket date of the application. If the
application is for a nuclear plant design
that is not based on or is not an
evolution of a nuclear plant that
operated in the United States, the
applicant should address how insights
from any relevant international
operating experience has been
incorporated into that plant.
Section 52.79(a)(41) requires that the
applicant evaluate the facility against
the standard review plan (SRP). For
COL applicants that reference the same
design certification rule and adopt a
design-centered approach in preparing
their COL applications, the NRC expects
that the ‘‘reference application’’ will
fully conform with this requirement and
then any follow-on applications will not
need to provide the evaluations for the
application information that is identical
to the reference application. The NRC
did not require applicants to evaluate
their facility against RG 1.206,
‘‘Combined License Applications for
Nuclear Power Plants.’’ However, the
NRC believes that RG 1.206 can provide
useful guidance to COL applicants in
preparing their applications and that
use of this guidance will facilitate the
NRC’s review.
The NRC has moved the requirement
that COL applicants submit a plantspecific PRA that was in proposed
§ 52.80(a) to a new § 52.79(a)(46) in the
final rule based on public comments. In
addition, the NRC has revised the
provision to require the applicants
submit a description of their PRA and
its results in their COL FSAR. The NRC
agrees with some commenters who
believed that applicants should not be
required to submit their complete plantspecific PRA and that, instead,
applicants should only be required to
provide a summary description of the
PRA and its results in their FSAR with
the understanding that the complete
PRA (e.g., codes) would be available for
NRC inspection at the applicant’s
offices, if needed. The NRC expects that,
generally, the information that it needs
to perform its review of the COL
application from a PRA perspective is
that information that will be contained
in applicants’ FSAR Chapter 19. The
NRC believes that COL application
guidance that the NRC is developing is
consistent with the industry comment
in that the staff does not expect the
complete PRA to be included in the
COL applicant’s FSAR. The guidance
focuses on qualitative description of
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insights and uses, but also
acknowledges that some quantitative
PRA results should be submitted.
Section 52.79(b) describes the variant
on the requirements in § 52.79(a) for a
combined license application that
references an early site permit. Former
§ 52.79(a) did not explicitly require the
application to address whether the
terms and conditions specified in the
early site permit under § 52.24 have
been or will be met by the combined
license holder, although this is implicit
by the inclusion of any terms and
conditions in the early site permit. To
remove any ambiguity in this matter,
§ 52.79(b)(3) requires that the FSAR
demonstrate that all terms and
conditions that have been included in
the early site permit will be satisfied by
the date of issuance of the combined
license. The NRC is revising
§ 52.79(b)(3) in the final rule based on
public comments to add an exclusion
for terms and conditions imposed under
§ 50.36(b) because such environmental
conditions should be addressed in the
environmental report and not in the
final safety analysis report. In addition,
the Commission is revising this
paragraph to add a provision that any
terms or conditions of the early site
permit that could not be met by the time
of issuance of the combined license
must be set forth as terms or conditions
of the combined license. This provision
is needed to address terms or conditions
of the early site permit that are related
to activities that will not take place until
after issuance of the combined license,
such as construction activities. A
similar change is being made to
§§ 52.79(d)(3) and (e)(3) for referenced
design certifications and manufacturing
licenses.
The NRC is making a revision to the
language in proposed § 52.79(b)(1) in
the final rule. Proposed § 52.79(b)(1)
stated that the FSAR for a combined
license application referencing an early
site permit need not contain information
or analyses submitted to the NRC in
connection with the early site permit.
This rule language led to a great deal of
discussion both within the NRC and in
public meetings on combined license
application guidance as to what the
NRC expected to see in a combined
license application that referenced an
early site permit. The NRC has
concluded that the FSARs in these
combined licenses applications must
either include or incorporate by
reference the SSAR for the early site
permit. The SSAR must be included or
incorporated into the COL FSAR to
ensure that matters addressed in the
SSAR legally become part of the FSAR
upon issuance of the COL. This will also
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49387
ensure that the information in the SSAR
is subject to control under § 50.59 after
issuance of the COL. For these reasons,
the NRC is modifying the language in
§ 52.79(b)(1) to state that the final safety
analysis report need not contain
information or analyses submitted to the
NRC in connection with the early site
permit. However, the final safety
analysis report must either include or
incorporate by reference the early site
permit site safety analysis report. With
this modification, the NRC intends to
convey that the combined license
applicant referencing the early site
permit does not need to resubmit, for
NRC review, information or analyses
that were already reviewed and resolved
in the early site permit proceeding (such
as information provided in responses to
NRC requests for additional
information). At the same time, the
NRC’s goal is to provide COL applicants
clear guidance as to what the combined
license application must contain to be
considered complete. For similar
reasons, the NRC is also modifying the
language in proposed §§ 52.79(c)(1),
(d)(1), and (e)(1) to include the
provision that the FSAR in the COL
application must either include or
incorporate by reference the FSAR for
the design approval, design
certification, or manufacturing license
that it is referencing. Note that each of
the existing design certification rules
covered in appendices A through D of
part 52 prohibit the use of incorporation
by reference in COL FSARs that
reference them. At the time those rules
were issued, the NRC was concerned
that the staff would not have easy access
to the final version of the design
certification FSAR (i.e., DCD) if it were
not included in the COL application.
The NRC will continue to put
restrictions in individual design
certification rules (and possibly in early
site permits, design approvals, or
manufacturing licenses) if it does not
have confidence that the safety analysis
reports can be easily accessed by the
staff if they are incorporated by
reference in COL applications.
Section 52.79(c) describes the
requirements for combined license
applications that reference a standard
design approval. Previously, no
guidance was provided regarding a
combined license application that
referenced a standard design approval.
The requirements in § 52.79(c) are
essentially the same as those for a
combined license application that
references a standard design
certification in § 52.79(d).
Section 52.79(d) describes the
requirements for combined license
applications that reference a standard
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design certification. Section 52.79(d)
states that the FSAR for a combined
license application referencing a
standard design certification need not
contain information or analyses
submitted to the NRC in connection
with the design certification. However,
the final safety analysis report must
either include or incorporate by
reference the standard design
certification final safety analysis report
(see discussion above) and must
contain, in addition to the information
and analyses otherwise required,
information sufficient to demonstrate
that the characteristics of the site fall
within the site parameters specified in
the design certification. In addition,
paragraph (d) requires that the plantspecific PRA information must use the
PRA information for the design
certification and must be updated to
account for site-specific design
information and any design changes or
departures. In the case where a COL
application is referencing a design
certification, the NRC only expects the
design changes and differences in the
modeling (or its uses) pertinent to the
PRA information to be addressed to
meet the submittal requirement of
§ 52.79(d)(1). Section 52.79(d) also
requires that the FSAR demonstrate that
the interface requirements established
for the design under § 52.47 have been
met and that all requirements and
restrictions that may have been set forth
in the referenced design certification
rule be satisfied by the date of issuance
of the combined license.
Section 52.79(e) describes the
requirements for a combined license
application that references a
manufactured reactor. Previously, no
guidance was provided regarding a
combined license application that
referenced a manufactured reactor.
These requirements are similar to those
for the content of an FSAR for a
combined license referencing a design
certification. Specifically, § 52.79(e)
states that the FSAR need not contain
information or analyses submitted to the
NRC in connection with the
manufacturing license. However, the
final safety analysis report must either
include or incorporate by reference the
manufacturing license final safety
analysis report and must contain, in
addition to the information and analyses
otherwise required, information
sufficient to demonstrate that the site
characteristics fall within the site
parameters specified in the
manufacturing license. This language
was slightly different in the proposed
rule and has been corrected in the final
rule to be consistent with § 52.79(d). In
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addition, § 52.79(e) requires that the
plant-specific PRA information must
use the PRA information for the
manufactured reactor and must be
updated to account for site-specific
design information and any design
changes or departures. Section 52.79(e)
also requires that the FSAR demonstrate
that the interface requirements
established for the design have been met
and that all terms and conditions that
have been included in the
manufacturing license be satisfied by
the date of issuance of the combined
license.
Section 52.80 is added to cover the
required technical contents of a
combined license application that are
not contained in the FSAR. These
application contents include the ITAAC,
the environmental report, and the
request to perform activities under
§ 50.10(e) with the associated redress
plan. This last item was moved to
§ 52.80(c) in the final rule from its
location in § 52.79(a)(23) in the
proposed rule. The NRC concluded that
it is preferable to include both the list
of proposed activities and the redress
plan as separate documents in the
application, outside of both the site
safety analysis report and the
environmental report. The NRC’s
conclusion is based on the fact that the
requirements in § 50.10(e) address both
safety and environmental issues.
Additional changes were made to
§§ 51.50 and 52.17 to implement this
concept.
g. Section 52.81, Standards for Review
of Applications
10 CFR parts 54 and 140 are added to
the list of standards that the NRC will
use to review combined license
applications. Part 54 addresses
applications for renewal of combined
licenses and part 140 includes the
requirements applicable to nuclear
reactor licensees with respect to
financial protection and Indemnity
Agreements to implement Section 170
of the AEA, commonly referred to as the
Price-Anderson Act.
h. Section 52.83, Finality of Referenced
NRC Approvals; Partial Initial Decision
of Site Suitability
The former § 52.83, Applicability of
part 50 provisions, is removed and
replaced by a new section addressing
the finality of NRC approvals which are
referenced in a combined license
application. Former § 52.83 provides
that, unless otherwise specifically
provided for in subpart C to part 52, all
provisions of 10 CFR part 50 and its
appendices applicable to holders of
construction permits for nuclear power
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reactors also apply to holders of
combined licenses. Similarly, § 52.83
provides that all provisions of 10 CFR
part 50 and its appendices applicable to
holders of operating licenses also apply
to holders of combined licenses issued
under this subpart, once the
Commission has made the findings
required under § 52.99. The NRC
believes that the former § 52.83 is not
necessary because this proposed
rulemaking will provide conforming
changes throughout 10 CFR part 50 (as
well as all other parts in Title 10
Chapter I) to identify which
requirements are applicable to
combined license applicants and
holders. Former § 52.83 also provides
provisions that address the duration of
a combined license and these provisions
would be moved to proposed § 52.104,
Duration of combined license.
The new § 52.83 states that, if an
application for a combined license
references an early site permit, design
certification rule, standard design
approval, or manufacturing license, the
scope and nature of matters resolved for
the application and any combined
license issued are governed by the
relevant provisions addressing finality,
including §§ 52.39, 52.63, 52.98, 52.145,
and 52.171. This provision clarifies the
relationship between a combined
license application and any other
license or regulatory approval that an
applicant may reference in the
combined license application as far as
issue resolution is concerned.
i. Section 52.89, Environmental Review
Section 52.89 is removed and
reserved for future use. Former § 52.89
required that, if a combined license
application references an early site
permit or a certified standard design,
the environmental review must focus on
whether the design of the facility falls
within the parameters specified in the
early site permit and any other
significant environmental issue not
considered in any previous proceeding
on the site or the design. Former § 52.89
further stated that, if the application
does not reference an early site permit
or a certified standard design, the
environmental review procedures set
out in 10 CFR part 51 must be followed,
including the issuance of a final
environmental impact statement, but
excluding the issuance of a supplement
under § 51.95(a). This provision is
removed because the requirements for
compliance with NEPA are now
captured in § 52.79(a) and in the
revisions to part 51.
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j. Section 52.91, Authorization To
Conduct Site Activities
Section 52.91(a)(2) formerly provided
requirements for a combined license
application that does not reference an
early site permit, but that contains a site
redress plan and states that the
applicant may not perform the site
preparation activities allowed by 10
CFR 50.10(e)(1) without first submitting
a site redress plan in accordance with
§ 52.79(a)(3), and obtaining the separate
authorization required by 10 CFR
50.10(e)(1). This provision further states
that authorization must be granted only
after the presiding officer in the
proceeding on the application has made
the findings and determination required
by 10 CFR 50.10(e)(2), and has
determined that the site redress plan
meets the criteria in § 52.17(c). This
provision is amended to state that
authorization may [emphasis added] be
granted only after the presiding officer
in the proceeding on the application has
made the findings and determination
required by 10 CFR 50.10(e)(2), and has
determined that the site redress plan
meets the criteria in § 52.17(c). This
amendment is consistent with
§ 52.91(a)(3), which states that
authorization to conduct the activities
described in 10 CFR 50.10(e)(3)(i) may
be granted only after the presiding
officer in the combined license
proceeding makes the additional finding
required by 10 CFR 50.10(e)(3)(ii). The
NRC believes that may is the proper
term to use in both of these provisions,
to reflect the NRC’s residual authority to
decline to authorize the ESP holder to
conduct § 50.10(e)(3)(i) activities, even
if the NRC’s regulations are met.
k. Section 52.93, Exemptions and
Variances
Paragraph (a) of § 52.93, which
includes a discussion of the
requirements regarding requests for an
exemption from any part of a referenced
design certification, is revised to state
that the Commission may grant the
request if it determines that the
exemption complies with any
exemption provisions of the referenced
design certification rule, or with § 52.63
if there are no applicable exemption
provisions in the referenced design
certification rule. This provision
formerly referred to compliance with
§ 50.12(a). The NRC is revising
paragraph (b) of this section in the final
rule to include an allowance for
applicants to request a variance from the
early site permit SSAR. The allowance
for requesting variances to the SSAR
was inadvertently omitted in the
proposed rule. Because the majority of
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the early site permit information that a
combined license applicant will be
referencing will be the information in
the SSAR, it is logical that the
allowance to request variances be
extended to the information in the
SSAR given that the NRC is allowing
variances to the permit itself. In the
final rule, the NRC is also adding a
provision to paragraph (b) of this section
that precludes the NRC from issuing a
variance once a construction permit,
operating license, or combined license
referencing the early site permit is
issued; any changes that would
otherwise require a variance should
instead be treated as an amendment to
the construction permit or combined
license.
Section 52.93 is also revised in the
final rule to add a discussion of requests
for departures from a referenced nuclear
power reactor manufactured under a
manufacturing license in new paragraph
(c) of this section. This provision was
inadvertently omitted in the proposed
rule, although similar provisions were
addressed in the proposed rule in
§§ 52.98 and 52.171. However, the
proposed rule incorrectly used the term
‘‘variance’’ to describe an applicationspecific change to a reactor
manufactured under a manufacturing
license. The NRC has corrected these
provisions in the final rule to use the
term ‘‘departure’’ for such changes,
consistent with the terminology used for
changes to a referenced design
certification. New paragraph (c) of this
section is consistent with these other
sections and states that an applicant for
a combined license who has filed an
application referencing a nuclear power
reactor manufactured under a
manufacturing license may include in
the application a request for a departure
from one or more design characteristics,
site parameters, terms and conditions,
or approved design of the manufactured
reactor. The NRC may grant a request
only if it determines that the departure
will comply with the requirements of 10
CFR 52.7, and that the special
circumstances outweigh any decrease in
safety that may result from the
reduction in standardization caused by
the departure. The criteria for granting
the departure is the exemption criterion
in § 52.7; however, the departure itself
is not considered an exemption (unless,
of course, the departure also involves a
non-compliance with an underlying
Commission regulatory requirement in
10 CFR Chapter I). Thus, the
Commission will not approve a
departure unless the Commission finds,
in addition to the routine exemption
criteria in § 52.7, that special
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circumstances outweigh any decrease in
safety that may result from the
reduction in standardization caused by
the departure. These limitations are
intended to maintain the
standardization of manufactured
reactors in operation to the extent
practicable. The licensee may not depart
from the design characteristics, site
parameters, terms and conditions, or
approved design of the manufactured
reactor through the provisions of
§ 50.59.
Finally, the provision contained in
paragraph (c) of this section in the 2006
proposed rule (and in paragraph (b) in
the former rule) has been moved to
paragraph (d) of this section in the final
rule. This provision states that issuance
of a variance under paragraph (b) or a
departure under paragraph (c) is subject
to litigation during the combined
license proceeding in the same manner
as other issues material to that
proceeding.
l. Section 52.97, Issuance of Combined
Licenses
The NRC has modified § 52.97 to be
more consistent with the parallel
provision in § 50.50, Issuance of
licenses and construction permits, by
including requirements that, after
conducting a hearing and receiving the
report submitted by the ACRS, the NRC
finds that there is reasonable assurance
that the applicant is technically and
financially qualified to engage in
activities authorized; and that issuance
of the license will not be inimical to the
common defense and security or to the
health and safety of the public. Section
52.97(c) is added, consistent with
§ 50.50, which states that a combined
license shall contain conditions and
limitations, including technical
specifications, as the NRC deems
necessary and appropriate. Former
§ 52.97(b)(2) is moved to new § 52.98
because the issues addressed in this
section are issues associated with
finality of combined license provisions.
m. Section 52.98, Finality of Combined
Licenses; Information Requests
Section 52.98, which addresses the
finality associated with the issuance of
combined licenses, is added to subpart
C of part 52, consistent with the other
subparts in 10 CFR part 52. Section
52.98(a) states that, after issuance of a
combined license, the Commission may
not modify, add, or delete any term or
condition of the combined license, the
design of the facility, the inspections,
tests, analyses, and acceptance criteria
contained in the license which are not
derived from a referenced standard
design certification or manufacturing
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license, except in accordance with the
provisions of §§ 52.103 or 50.109, as
applicable.
Section 52.98 includes provisions to
clarify the applicability of the change
processes in 10 CFR part 50 and Section
VIII of the design certification rules in
10 CFR part 52 to a combined license.
Section 52.98(b) states that the change
processes in 10 CFR part 50 apply to a
combined license that does not
reference a design certification rule or a
reactor manufactured under a
manufacturing license. Section 52.98(c)
states that the change processes in
Section VIII of the design certification
rules apply to changes within the scope
of the referenced certified design.
However, if the proposed change affects
the design information that is outside of
the scope of the design certification
rule, the part 50 change processes apply
unless the change also affects the design
certification information. For that
situation, both change processes may
apply.
Section 52.98(d) is added to address
changes to a combined license that
references a reactor manufactured under
a manufacturing license. Section
52.98(d)(1) states that, if the combined
license references a reactor
manufactured under a subpart F
manufacturing license, then changes to
or departures from information within
the scope of the manufactured reactor’s
design are subject to the change
processes in § 52.171. Note that the
proposed rule incorrectly used the term
‘‘variance’’ to describe an applicationspecific change to a reactor
manufactured under a manufacturing
license. The NRC has corrected this
provision in the final rule to use the
term ‘‘departure’’ for such changes,
consistent with the terminology used for
changes to a referenced design
certification. Section 52.98(d)(2) states
that changes that are not within the
scope of the manufactured reactor’s
design are subject to the applicable
change processes in 10 CFR part 50 (e.g.,
§§ 50.54, 50.59, and 50.90). The NRC
made all of these requirements to
clarify, in one location, the finality
provisions applicable to all portions of
a combined license.
Finally, the NRC has added a new
paragraph (g) to the ‘‘finality’’ section in
each subpart of part 52, including
§ 52.98, entitled ‘‘Information requests,’’
which delineates the restrictions on the
NRC for information requests to the
holder of the combined license. This
provision is analogous to the former
provision on information requests in
paragraph 8 of appendix O to parts 50
and 52, and is based upon the language
of § 50.54(f). For combined licenses, this
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proposed provision is in § 52.98(g), and
requires the NRC to evaluate each
information request of the holder of a
combined license to determine that the
burden imposed by the information
request is justified in light of the
potential safety significance of the issue
to be addressed in the information
request. The only exception is for
information requests seeking to verify
compliance with the current licensing
basis of the facility. If the request is
from the NRC staff, the request will first
have to be approved by the EDO or his
or her designee.
n. Section 52.103, Operation Under a
Combined License
Section 52.103(g) formerly required
the NRC to find that the acceptance
criteria in the combined license are met
before operation of the facility, but did
not refer to loading of fuel. However,
§ 52.103(f) stated that fuel loading and
operation under the combined license
will not be affected by the granting of
a petition to modify the terms and
conditions of the combined license
unless a Commission order is made
immediately effective. In the proposed
rule, this section was amended to
require the NRC to find that the
acceptance criteria in the combined
license are met before fuel load and
operation of the facility. The NRC has
decided not to adopt the proposed rule
language which would have precluded
loading of fuel into the reactor until
acceptance criteria have been met. The
NRC believes that the rule should
reflect, as closely as possible, the
statutory requirement in Section 185.b
of the AEA. The NRC has historically
viewed ‘‘operation’’ as including
loading of fuel into the reactor, however
it is not necessary to change the
language of § 52.103(g) to continue the
historical practice. The NRC believes
that this is the common interpretation of
§ 52.103(g).
o. Section 52.104, Duration of Combined
License; § 52.105, Transfer of Combined
License; § 52.107, Application for
Renewal; § 52.109, Continuation of
Combined License; and § 52.110,
Termination of License
Five new provisions are added to
subpart C of part 52 for consistency with
the other subparts in 10 CFR part 52 and
to parallel requirements in 10 CFR part
50 for operating licenses. Section
52.104, addresses the duration of a
combined license and contains
requirements that formerly existed in
§ 52.83. In addition, the Commission
has amended these requirements to
indicate that, where the Commission
has allowed operation under a
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combined license during an interim
period under § 52.103(c), the period of
operation is not to exceed 40 years from
the date allowing operation during the
interim period.
Section 52.105 provides requirements
for the transfer of a combined license
that refer the applicant to § 50.80.
Section 52.107 provides a reference to
10 CFR part 54 for the renewal of a
combined license.
Section 52.109 provides provisions
for the continuation of a combined
license and § 52.110 would provide
requirements for the termination of a
combined license. Formerly, part 52 did
not address decommissioning of
combined licenses (reactors that are
manufactured under a part 52
manufacturing license do not raise
decommissioning concerns until they
are emplaced at a site, inasmuch as a
manufacturing license does not permit
loading of fuel or operation) and the
termination of the combined license. By
contrast, §§ 50.51 and 50.82 address the
permanent shutdown of a nuclear power
plant, its decommissioning, and the
termination of the part 50 operating
license. There are two possible ways of
addressing this omission: §§ 50.51 and
50.82 could be modified to reference
combined licenses under part 52, or the
provisions analogous to these sections
could be added to part 52. The NRC
believes that the second alternative is
the best approach. The combined
license holder’s responsibilities upon
expiration of its license is more a matter
of regulatory authority and therefore is
best placed in part 52. While the
question is closer with respect to
decommissioning, the NRC believes that
most users would likely turn to part 52
rather than part 50 to determine the
requirements for decommissioning,
inasmuch as decommissioning involves
questions of both procedure and
technical requirements.
9. Subpart D, Reserved
10. Subpart E, Standard Design
Approvals (§§ 52.131 Through 52.147)
The former appendix O to part 52 set
forth the requirements for NRC staff
approval of a standard design for a
nuclear plant or a major portion of a
nuclear plant. This licensing process
was first adopted by the NRC in 1975
and has been used many times,
including issuance of four final design
approvals (FDAs) under appendix O to
part 52 from 1994 through 2004. These
FDAs were issued during previous
design certification reviews when FDAs
were a prerequisite to certification of a
standard plant design (see SOC
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discussion on 10 CFR 52.43 in this
document).
When the NRC adopted part 52 in
1989, the Commission did not reexamine the regulatory scheme for
standard design approvals to determine
if the bases for adopting part 52 and the
licensing processes codified in part 52
would also be an impetus for
reorganizing the design approval
process. However, the Commission did
undertake a re-examination of appendix
O to part 52 in the 2003 proposed rule
and proposed certain changes. In view
of the substantial reorganization and
rewriting of part 52 in this rulemaking,
the Commission gave further
consideration to the licensing process in
appendix O to part 52 and has made
additional changes to enhance the
regulatory effectiveness and efficiency
of that licensing process.
The Commission continues to believe
that the best approach for obtaining
early resolution of design issues is
through the design certification process
in subpart B of part 52. Design
certification will provide greater finality
and standardization than the design
approval process. Consequently, the
Commission favors use of the design
certification process, which suggests
that the design approval process could
be eliminated. However, given the
frequent use of appendix O to part 52
in the past, the Commission has decided
to retain this process and to reorganize
and reformat the design approval
process to be consistent with other
subparts.
The design approval process, formerly
located in appendix O to part 52, has
been moved to subpart E of part 52 and
reformatted to be consistent with other
subparts. A new § 52.133 was created to
describe the relationship of the design
approval process with other subparts.
An FDA may be referenced in an
application for a construction permit or
operating license under part 50 or a
design certification, combined license,
or manufacturing license under part 52.
The filing requirements for design
approvals are consistent with other
subparts of part 52. The applicants may
still request approval of either the entire
facility or major portions thereof, but
the applications are limited to final
design information. There are several
reasons for this change. First, the
Commission’s recent experience with
FDAs and design certifications
demonstrates that nuclear plant
designers are technically capable of
developing essentially complete and
final design information for NRC review
and approval. Furthermore, the
economic incentives with respect to
design certification also apply to final
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design approvals. In addition, approval
of final design information removes the
unpredictability of issuing a
construction permit that references only
preliminary design information and
initiating construction while the final
design information is being developed.
Approval of a final design ensures early
consideration and resolution of
technical matters before there is any
substantial commitment of resources
associated with the construction of the
plant, which will greatly enhance
regulatory stability and predictability.
The Commission has decided that the
contents of applications for design
approvals should contain essentially the
same technical information that is
required of design certification
applications (e.g., demonstration of
compliance with technically relevant
Three Mile Island requirements,
proposed technical resolutions of
unresolved safety issues and mediumand high-priority generic safety issues,
and design-specific probabilistic risk
assessment information).
Regarding applications for a major
portion of the standard plant design,
such as the nuclear steam supply
system, the application only needs to
contain the information required for the
contents of applications that are
applicable to the major portion of the
plant for which NRC staff approval is
requested.
The requirements for contents of
applications for design approvals
(§ 52.137) were renumbered to be
consistent with the numbering of
requirements in § 52.47. Also, many of
the public comments on contents of
applications for design certification
apply to the requirements for design
approvals (see the SOC of this document
for the discussion for § 52.47). Some
commenters recommended that the
requirement for coping with
emergencies [§ 52.137(a)(11)] be deleted
because applicants for design approvals
will not be responsible for certain
emergency planning design features.
The Commission disagrees with this
comment. This requirement was taken
from the original appendix O of part 52,
paragraph 3, and it applies to design
features for coping with emergencies in
the operation of the reactor, not for
emergency planning.
A new § 52.139, which specifies the
standards that will be used to review
applications for design approvals and
new §§ 52.145 and 52.147, which
specify the finality and duration of
design approvals was added to be
consistent with other subparts. In a
letter dated November 13, 2001, NEI
commented that ‘‘Industry recommends
FDAs be valid for 15 years.’’ The
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Commission agrees with NEI’s
recommendation and has decided that
the duration of standard design
approvals should correspond to the
duration of design certifications,
inasmuch as both design approvals and
design certifications constitute
approvals of nuclear power plant
designs, and the period of effectiveness
of the approval from a technical
standpoint is not a function of whether
the approval is granted by the NRC staff
or the Commission. Some commenters
recommended that § 52.147 be rewritten
to provide for renewals of standard
design approvals. The Commission
disagrees with this comment. The
original appendix O to part 52 did not
contain a process for renewing design
approvals and most of the design
approvals issued under appendix O to
part 52 were for a 5-year duration. In
this rulemaking, the Commission has
tripled the duration for a design
approval and believes that renewals will
not be necessary. Also, as stated before,
the Commission favors the use of the
design certification process, which
includes a process for renewals.
11. Subpart F, Manufacturing Licenses
The following discussion explains the
requirements in subpart F of part 52
generically, and covers §§ 52.151,
52.153, 52.155, 52.156, 52.157, 52.159,
52.161, 52.163, 52.165, 52.167, 52.169,
52.171, 52.173, 52.175, 52.177, 52.179,
and 52.181.
Former appendix M of parts 50 and 52
set forth the NRC’s requirements
governing manufacturing licenses.
Appendix M, which was first adopted
by the NRC in 1973 as an appendix to
part 50, provided for issuance of a
license authorizing the manufacture of a
nuclear power reactor to be
incorporated into a nuclear power plant
under a construction permit and
operated under an operating license at
a different location from the place of
manufacture. Under the licensing
regime in former appendix M, the NRC
did not approve a final reactor design to
be manufactured as part of the issuance
of the manufacturing license. Rather,
analogous to the two-step construction
permit/operating license process, the
NRC would issue a manufacturing
license based upon the review and
approval of a preliminary design
equivalent to that provided in a
construction permit application. Upon
issuance of the manufacturing license,
manufacturing of the reactor can
commence, although the NRC must
approve the final design of the
manufactured reactor by license
amendment before the manufactured
reactor may be transported from the
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place of manufacture to the site where
it is to be operated.
When the NRC adopted part 52 in
1989, it added appendix M to part 52.
However, the NRC did not re-examine
the regulatory scheme for manufacturing
licenses in order to determine if the
bases for adopting part 52 would also be
an impetus for changing the regulatory
scheme for manufacturing licenses. Nor
did the NRC undertake such a reexamination as part of the process
leading to the 2003 proposed rule.
However, the NRC has reconsidered the
efficacy of the manufacturing license
process in former appendix M to part
52, and has decided to adopt substantial
changes to those requirements in order
to enhance regulatory effectiveness and
efficiency. These new requirements are
contained in a new subpart F to part 52.
The most important shift in the
manufacturing license concept in
subpart F is that a final reactor design,
equivalent to that required for a
standard design certification under part
52 or an operating license under part 50,
must be submitted and approved before
issuance of a manufacturing license.
There are several reasons for this shift.
First, the Commission’s experience with
standard design certifications
demonstrates that nuclear power plant
designers are technically capable of
developing a complete reactor design for
Commission review. Furthermore, the
economic incentives and limitations
with respect to approval of a standard
reactor design certification also apply to
the approval of a design of a
manufactured reactor. Indeed, one could
argue that the holder of a manufacturing
license may structure the commercial
transaction to reduce the economic risk
associated with the application for a
manufacturing license for a final reactor
design, as compared to the economic
risk associated with a standard design
certification. Second, approval of a final
reactor design removes the former
awkward regulatory process of issuing a
manufacturing license, and
subsequently amending the license
when a final design is submitted.
Approval of a final design ensures early
consideration and resolution of
technical matters before there is any
substantial commitment of resources
associated with the actual manufacture
of the reactor, which will greatly
enhance regulatory stability and
predictability. Finally, Commission
approval of standardized manufacturing
processes, coupled together with the
potential for a stable workforce and the
application of manufacturing process
feedback, has great opportunities for
maintaining and even improving the
quality and consistency of manufacture,
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as compared to the traditional method
of constructing reactors onsite by a
variety of contractors and
subcontractors.
The technical information required to
be included in an application for a
manufacturing license, as set forth in
§§ 52.157 and 52.158, reflects both the
expansion of the scope of approval to
include the final design of the reactor to
be manufactured, as well as lessons
learned with respect to the NRC’s
review of early site permits. Section
52.157, which sets forth the technical
information to be submitted in support
of the design of a reactor, is derived
from the existing requirements in
current part 52, subparts B and C,
governing the technical information to
be submitted in support of an
application for a standard design
certification and combined license. In
addition, § 52.157 requires that the
application address the provisions with
respect to the demonstration by test,
analysis, experience, or a combination
thereof, of simplified, inherent, passive,
or other innovative means to
accomplish safety functions, or the
results of testing of a prototype plant, as
set forth in revisions to § 50.43. As
discussed separately with respect to
§ 50.43, these testing and prototype
requirements incorporated into § 50.43
were derived from the former
requirements in § 52.47(b).
Information which must be submitted
as part of an application, but is not
typically considered part of a final
safety analysis report, is identified in
§ 52.158. This includes proposed ITAAC
to be used by the licensee who will
construct and operate a nuclear power
plant at its site using the manufactured
reactor and an environmental report for
the manufactured reactor. Note that, in
the final rule, the NRC has moved
proposed § 52.158(a) to a new
§ 52.157(f)(31) which requires that
manufacturing license applicants
submit a description of the designspecific PRA and its results in the
FSAR. The NRC agrees with some
commenters that applicants should not
be required to submit their complete
design-specific PRA and that, instead,
applicants should only be required to
provide a summary description of the
PRA and its results in their FSAR with
the understanding that the complete
PRA (e.g., codes) would be available for
NRC inspection at the applicant’s
offices, if needed. The NRC expects that,
generally, the information that it needs
to perform its review of the
manufacturing license application from
a PRA perspective is that information
that will be contained in applicants’
FSAR Chapter 19.
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The environmental report must
address SAMDAs, similar to standard
design certifications, because the design
approval stage is usually the most costeffective opportunity for incorporating
design features for addressing severe
accidents. The NRC notes that the
environmental report need not address
environmental impacts associated with
the actual manufacture of the reactor at
any manufacturing location, inasmuch
as a manufacturing license does not
represent NRC approval of any specific
location, facility, or appurtenance for
manufacturing. Rather, the NRC is
approving a reactor design for
manufacture and the ITAAC for
verifying that it has been acceptably
manufactured and integrated into a
nuclear power facility so that it can be
safely operated in accordance with the
approved manufactured reactor design,
the NRC’s regulations, and the
requirements of the AEA. These
determinations were reflected in
proposed §§ 52.158(c)(1), 51.54, and
51.75(c)(3). However, in the final rule,
the Commission has removed from
proposed §§ 52.158(c)(1) and (2) (final
§§ 52.158(b)(1) and (2)) the rule
language addressing the content of the
environmental report, and integrated
that language into §§ 51.54 and
51.75(c)(3). Proposed § 52.158(c)(2)
(final § 52.158(b)(2)) has been revised in
the final rule to address the scope of the
environmental report if the
manufacturing license application has
referenced a standard design
certification.
Section 52.163 of the March 2006
proposed rule would have required that
the NRC conduct a ‘‘mandatory’’ hearing
in connection with the initial issuance
of a manufacturing license, even though
the AEA does not require a mandatory
hearing for issuance of manufacturing
licenses. For the reasons set forth in the
NRC’s response to Commission
Question 2, and the discussion on
§§ 2.104 and 2.105, the NRC has
decided not to require a ‘‘mandatory’’
hearing for initial issuance of a
manufacturing license, and § 52.163 is
revised in the final rule to refer to a
publication of a notice of proposed
action under § 2.105, rather than a
notice of hearing under § 2.104.
In light of the NRC’s review and
approval of a final design as part of
issuance of a manufacturing license, the
final rule provides a greater degree of
finality to a manufacturing license as
compared with a standard design
certification. Under § 52.171(a)(1), the
same degree of issue finality accorded to
the ‘‘certified design’’ applies
throughout the term of the
manufacturing license. Under this
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provision, the NRC may not impose any
change or modification to the approved
design (including site parameters, or
design characteristics) for the
manufacturing license unless the NRC
determines that the change or
modification is necessary either for
adequate protection or for compliance
with requirements applicable and in
effect at the time the manufacturing
license was issued. Similarly, the
manufacturing license holder may not
make changes to the design under the
provisions of 10 CFR 50.59. Any change
to the design will require a license
amendment. The Commission regards
this as similar to the level of change
control imposed on designs which are
the subject of a standard design
certification. The Commission is
imposing this stringent level of change
control because one of the key reasons
for licensing manufactured reactors is to
enhance standardization—one of the
original objectives of the 1989 part 52
rulemaking. Unlike design certification,
which is an approval of a ‘‘paper
design,’’ the NRC’s proposed concept of
a manufacturing license is pre-approval
of the procurement, manufacturing, and
quality assurance processes that
translates the approved reactor design
into a manufactured assembly in a
controlled environment, with the
capability to optimize techniques and
procedures based upon feedback. Some
of these advantages may be lost if each
‘‘manufactured’’ reactor were treated as
a ‘‘one-off’’ custom product. Imposing
the discipline of a license amendment
process should ensure that a profusion
of changes are not made to the approved
design at random intervals. The
Commission disagrees with commenters
on the proposed rule that the design of
a manufactured reactor should be
subject to less-stringent change
provisions than a standard design
certification. The commenters have not
demonstrated that there are special or
unique aspects of manufacturing, as
compared with the construction of a
nuclear power plant based upon a
referenced standard design certification,
that would weigh against maintaining
the high degree of design
standardization achieved by design
certification. One commenter correctly
noted that changes in such
manufacturing matters as procurement,
manufacturing processes, or quality
assurance are not subject to the
proposed § 52.171(b)(1) change
restriction, because these matters do not
constitute changes to the approved
design of the reactor to be
manufactured. These changes would be
governed by the applicable change
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process and restrictions already
established in the Commission’s
regulations such as § 50.59, and
§ 50.54(a), and may not require license
amendments.
The only relevant rationale provided
by the commenters is that obsolescence
of components and component
manufacturers’ changes would
necessitate minor changes to the reactor
design over a 15-year period. Although
the Commission acknowledges the
likelihood of these factors, the NRC staff
does not see any reason why these
factors are more likely to affect the
design of a manufactured reactor as
compared with the design approved in
a design certification. It is not clear why
a change in component sourcing would
necessarily result in a ‘‘design change’’
requiring an amendment to the
manufacturing license. Finally, the
Commission notes that the proposed
rule does not mandate ‘‘zero changes in
a reactor design.’’ As specifically stated
in the SOC of the March 13, 2006 (71
FR 12801), proposed rule (second
column), proposed § 52.171(b)(1) would
allow the manufacturer to make changes
to the approved design to be
manufactured, albeit by license
amendment.
The final rule provides that the term
of a manufacturing license to be for no
less than 5, or more than 15 years from
the date of issuance. The Commission
established the 15-year maximum term
to be consistent with the maximum term
for a standard design certification. The
5-year minimum term was established
by the Commission to encourage the use
of a manufacturing license for the
manufacture of more than one nuclear
power reactor. The language of § 52.171
has been corrected in the final rule by
replacing the reference in paragraph
(b)(1) to § 50.12 with a reference to
§ 52.7, and replacing the term,
‘‘exemption,’’ in paragraph (b)(2) with
‘‘departure.’’
In proposed § 52.167(b)(3), the
Commission included a provision
which would have required the
manufacturing license to specify the
number of reactors authorized to be
manufactured under the manufacturing
license. Upon further consideration in
response to a comment on the proposed
rule, the Commission has decided that
there is no valid regulatory basis for
including this provision, and it may in
fact serve as a disincentive for the
manufacturer to improve the efficiency
and productivity of the manufacturing
process. Accordingly, this provision is
not included in the final rule.
Under § 52.177(c), the holder of a
manufacturing license may not
commence manufacturing of a reactor
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less than 3 years before the expiration
date, but may continue the
manufacturing of a reactor whose
manufacture commenced before the 3year deadline up to license expiration.
If, however, an application for renewal
is timely-filed with the NRC,
manufacturing of a reactor whose
manufacture commenced before the 3year deadline may continue until the
time that the NRC completes action on
the renewal application in accordance
with the Timely Renewal Doctrine of
the Administrative Procedure Act
(APA). The Commission believes that
the timely renewal period should be
based upon the time reasonably needed
by the agency to complete action on a
renewal application, so that an
applicant’s reliance upon timely
renewal is the rare exception rather than
the rule. The NRC selected the 3-year
deadline as a reasonable period for
completing the manufacture of a nuclear
power reactor, based in large part upon
public statements by various reactor
vendors that they have set goals for
constructing complete nuclear power
plants onsite within 3 years. It seems
reasonable, therefore, that a
manufactured reactor, built in a
controlled environment using industrial
manufacturing processes, would be able
to be manufactured in the same 3-year
period as the construction of an entire
facility onsite. Paragraph (b) is corrected
in the final rule by removing the phrase,
‘‘that the Commission may impose,’’ in
order to avoid the possible
misinterpretation that the Commission
could choose not to impose new
adequate protection requirements
identified by the Commission. In
addition, paragraph (b)(2) is corrected
by removing the reference to ‘‘site
permit’’ and substituting the term,
‘‘manufacturing license.’’
The final rule does not require that
the manufacturing license specify an
earliest and latest date for completion of
manufacture of any individual reactor.
Section 185 of the AEA directs that
‘‘[t]he construction permit shall state the
earliest and latest date for completion of
the construction or modification.’’
Inasmuch as a manufacturing license is
not a construction permit, there does
not appear to be any legal need for the
manufacturing license to specify the
earliest and latest date of completion of
manufacture. The language of this
section has been corrected in the final
rule to make clear that the duration of
the renewed manufacturing license
consists of the renewed term plus any
period remaining on the superseded
license (analogous to the determination
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of the duration of a renewed operating
license under part 54).
12. Subpart G of Part 52 [Reserved]
13. Subpart H of Part 52—Enforcement
This subpart contains two provisions,
§ 52.301 and § 52.303, which are
comparable to former § 52.111 and
§ 52.113, and are analogous to
provisions contained in other parts of 10
CFR Chapter I imposing requirements
on regulated entities. Section 52.301
reiterates, and provides notice to
licensees and applicants under part 52
of the Commission’s authority to obtain
injunctions or other court orders for the
enumerated violations. Section 52.113
provides notice to all persons and
entities subject to part 52 that they are
subject to criminal sanctions for willful
violations, attempted violations, or
conspiracy to violate certain regulations
under part 52. The regulations listed in
paragraph (b), for which criminal
sanctions do not apply, have been
updated to reflect the final part 52
rulemaking. Section 52.99 was
erroneously listed in paragraph (b) in
the proposed rule. Because that
regulation contains substantive
requirements which are promulgated
under Section 161.b., i, and o of the
AEA, it has been removed from the list
of regulations in paragraph (b).
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14. Appendices A, B, C, and D to Part
52—Design Certifications for ABWR,
System 80+, AP600, and AP1000
The NRC amended paragraphs VI.B.4,
5, and 6 of the design certification rules
(DCRs) in appendices A, B, and C to part
52 for the U.S. ABWR, System 80+, and
AP600 designs, respectively, by
substituting the phrase ‘‘but only for
that plant’’ for the erroneous phrase
‘‘but only for that proceeding’’
(emphasis added). The new phrase
correctly characterizes the scope of
issue resolution in three situations.
Paragraph VI.B.4 describes how issues
associated with a DCR are resolved
when an exemption has been granted for
a plant referencing the DCR. Paragraph
VI.B.5 describes how issues are resolved
when a plant referencing the DCR
obtains a license amendment for a
departure from Tier 2 information.
Paragraph VI.B.6 describes how issues
are resolved when the applicant or
licensee departs from the Tier 2
information on the basis of paragraph
VIII.B.5, which waives the requirement
to obtain NRC approval for such
departures. Thus, once a matter (e.g., an
exemption in the case of paragraph
VI.B.4) is addressed for a specific plant
referencing a DCR, the adequacy of that
matter for that plant would not
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ordinarily be subject to challenge in any
subsequent proceeding or action (such
as an enforcement action) listed in the
introductory portion of paragraph IV.B,
but there would not be any issue
resolution on that subject matter for any
other plant.
Each of the DCRs includes a Section
VIII on processes for changes and
departures. These processes apply to
changes and departures depending upon
the category of certification information
affected. For plant-specific Tier 2
information, the departure process
established in the rule mirrors, in large
part, that in the former 10 CFR 50.59.
The final rule amends paragraph
VIII.B.5 of the DCRs in appendices A, B,
and C to conform the terminology in the
§ 50.59-like process to that used in the
current § 50.59. This amendment
deleted references to unreviewed safety
questions and safety evaluations, and
conformed the evaluation criteria
concerning when prior NRC approval is
needed. Also, a definition was added to
the DCRs (paragraph II.G) for ‘‘departure
from a method of evaluation’’ to support
the evaluation criterion in paragraph
VIII.B.5.b(8) of appendices A, B, and C
to part 52.
In an earlier rulemaking (see 64 FR
53582; October 4, 1999), the NRC
revised § 50.59 to incorporate new
thresholds for permitting departures
from a plant design as described in the
FSAR without NRC approval. For
consistency and clarity, similar changes
were adopted for part 52 applicants or
licensees. Because of some differences
in how the requirements are structured
in the DCRs, certain criteria contained
in § 50.59 are not necessary for or
applicable to part 52 and are not being
included in this rule. One criterion
definition that the NRC did include was
from § 50.59 for a ‘‘Departure from a
method of evaluation,’’ which is
appropriate to include in this
rulemaking so that the eighth criterion
in paragraph VIII.B.5.b of appendices A,
B, and C to part 52 will be implemented
as intended.
Each of the DCRs includes a special
process in Section VIII for departures
from selected severe accident issues.
The Commission believes that the
resolution of severe accident issues
should be preserved and maintained in
the same fashion as all other safety
issues that were resolved during the
design certification review (refer to SRM
on SECY–90–377). However, because of
the increased uncertainty in severe
accident issue resolutions, the
Commission codified separate criteria in
paragraph B.5.c of Section VIII for
determining if a departure from design
information that resolves these severe
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accident issues would require a license
amendment. The final rule amends
paragraph B.5.c to clarify that the
special process applies to ex-vessel
severe accident design features that are
described in the plant-specific design
control document (DCD).
For purposes of applying the special
criteria in paragraph B.5.c of Section
VIII, severe accident resolutions are
limited to those design features where
the intended function of the design
feature is relied upon to resolve
postulated accidents when the reactor
core has melted and exited the reactor
vessel (ex-vessel severe accidents) and
the containment is challenged. The
location of the ex-vessel severe accident
design information in the DCD is not
important to the application of this
special departure process in paragraph
B.5.c. Some design features may have
intended functions to meet both ‘‘design
basis’’ requirements and to resolve exvessel severe accidents. If these design
features are reviewed under paragraph
VIII.B.5, then the appropriate criteria
from either paragraph B.5.b or B.5.c are
selected depending upon which
function the departure is being taken
from.
Each of the DCRs in appendices A, B,
and C to part 52 includes a section on
records and reporting. The NRC revised
paragraph X.B.3.b in appendices A, B,
and C to part 52 to change the reporting
frequency from quarterly to semiannually, and to extend the period of
increased reporting frequency, relative
to the frequency of 10 CFR 50.59(d) and
50.71(e)(4), from the date of a license
application that references a DCR to the
date that the Commission makes the
finding under 10 CFR 52.103(g). The
requirement to report plant-specific
departures from, and updates to, the
design control document during the
interval from the application for a
combined license until the Commission
makes the finding under § 52.103(g) is to
facilitate NRC’s monitoring of changes
to the nuclear power plant, to achieve
a common understanding of how the asbuilt facility conforms to the design
information, and to adjust the
inspection program to reflect the design
changes.
The amendment to paragraph X.B.3.b
of appendices A, B, and C to part 52
reduced the frequency of reporting
during the period of construction and
increased the frequency of reporting
during the application review period.
The NRC believes that these changes in
the reporting burden balance each other
and provide the information needed by
the NRC to fulfill its responsibilities in
the licensing of future nuclear power
plants. In order to make the finding
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under § 52.103(g), the NRC must
monitor the design changes made under
Section VIII of the DCRs. Frequent
reporting of design changes will be
particularly important in times when
the number of design changes could be
significant, such as during the
procurement of components and
equipment, the detailed design of the
plant before and during construction,
and during pre-operational testing. After
the facility begins operation, the
frequency of reporting would revert to
the requirement in paragraph X.B.3.c,
which is consistent with operating plant
requirements.
Additional editorial changes to the
design certification rule language in
appendices A, B, C, and D to part 52 are
discussed in the NRC’s responses to
public comments on Question 11 (see
Section IV of this document).
15. Appendix N to Part 52—Combined
Licenses for Nuclear Power Reactors of
Identical Design
Prior to this final rulemaking,
appendix N in parts 50 and 52
contained the NRC’s procedures
governing the review and issuance of
licenses for nuclear power plants of
‘‘duplicate design.’’ Hearings for
applications filed under appendix N in
both parts 50 and 52 are governed by
subpart D of part 2. In the March 2006
proposed rule, the NRC proposed
deleting appendix N in part 52, and
retaining these provisions only in part
50. Although no comment was received
on this proposal, the NRC has decided
to withdraw its proposal to delete
appendix N in part 52. Since the
preparation of the March 2006 proposed
rule, several industry groups have
announced their intention to seek
combined licenses utilizing the same
design. In view of this industry
development, the NRC believes that
there is potential utility to keeping the
option of appendix N in part 52 open to
potential combined license applicants.
Accordingly, the NRC is retaining in
part 52 the procedural alternative
provided in appendix N to part 52, and
to revise its language to make its
provisions applicable to combined
licenses using identical designs. As part
of this revision, the NRC set forth more
explicit direction on the information to
be submitted, the NRC docketing
review, notice, and the content of the
EIS under appendix N of part 52.
However, the NRC decided against a
wholesale revision of appendix N to
part 52, together with conforming
changes in part 51, inasmuch as these
changes were not the subject of public
comment, and because such a course of
action would have delayed the overall
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part 52 rulemaking. Inasmuch as the
changes to appendix N of part 52
constitute, in essence, revisions to the
NRC’s rules of procedure and practice
(albeit located within part 52), the NRC
may adopt them in final form without
further notice and comment, under the
rulemaking provisions of the APA, 5
U.S.C. 553(b)(A).
The overall concept of the revised
appendix N to part 52 is that each
application is to be treated as a separate
application, with the exception of the
common design. Hence, appendix N to
part 52 requires separate applications,
separate determinations of sufficiency
for docketing, separate notices of
docketing, and so forth. Sections
requiring further explanation are
discussed below.
Paragraph 2 of appendix N to part 52
requires that each application state that
the applicant wishes to have the
application considered under appendix
N to part 52, and to list all of the
applications that are to be treated
together. This requirement ensures that
the NRC is clearly informed of the
intentions of all applicants, and to
ensure that any individual reviewing
the application can easily determine all
of the applications using the identical
(‘‘common’’) design.
Paragraph 3 of appendix N to part 52
requires that each application identify
the common design, and that the FSAR
either incorporate by reference or
include the common design. This
ensures that there will be a single
physical FSAR document that may be
utilized by the NRC, and viewed by
members of the public.
Paragraph 5 of appendix N to part 52
provides that, upon an NRC
determination that each application is
acceptable for docketing under 10 CFR
2.101, each application will be
separately docketed (i.e., each
application will be given a separate
docket number, but that docket number
may include a special designator
signifying that it is part of a group of
applications filed under appendix N to
part 52). Ordinarily, the NRC will
publish in the Federal Register a
separate notice of docketing for each
application, so that delays in the
docketing of one application will not
delay the docketing and subsequent
technical review of other applications
filed in accordance with appendix N to
part 52. However, if circumstances
allow (e.g., sufficiency review for
multiple applications are completed
simultaneously), the NRC may publish a
single notice of docketing for multiple
applications. The notice of docketing
must state that the application will be
processed under the provisions of 10
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49395
CFR part 52, appendix N and subpart D
of part 2. As discussed under subpart D
of part 2, the NRC also has discretion to
either publish a notice of hearing for
each application (possibly with the
period for the filing of petitions to
intervene running from the notice of
hearing for the last application of the
group), or to publish a joint notice of
hearing for multiple applications.
Paragraph 6 of appendix N to part 52
sets forth the procedures by which the
NRC will fulfill its obligations under
NEPA. The NRC staff will prepare a
separate draft EIS for each application,
but the NRC may conduct joint scoping
on environmental issues related to the
common design. If the applications
reference a standard design certification
or the use of a manufactured reactor,
then the EIS must incorporate by
reference the EA prepared for either the
design certification or the
manufacturing license, as applicable.
The NRC has decided that the EA need
not be included in the EIS. The
Commission has required other
documents to be incorporated into the
FSAR in order to maximize the utility
and ease of use of the FSAR, which is
used repeatedly by the NRC staff over
the lifetime of the licensed reactor. By
contrast, the EIS is not typically utilized
by the staff in such a manner; hence, the
NRC deemed it unnecessary to require
physical incorporation of the referenced
design certification or manufacturing
license EA into the referencing
combined license EIS.
Paragraph 7 of appendix N to part 52
requires the ACRS to report on each of
the combined license applications, as
required by § 52.87. Each ACRS report
is to be limited to the safety matters
which are not relevant to the common
design. In addition, the ACRS must
issue a report on the safety of the
common design—except for those
matters relevant to the safety of a
referenced design certification or
manufactured reactor. Issuance of
separate reports for each application
will facilitate NRC staff internal review,
consideration, and response to the
ACRS report. It will also ensure that
issues relevant to one application (e.g.,
siting) are not addressed in the
proceeding and hearing for another
application. Issuance of a single report
on the common design will also
facilitate the issuance of the presiding
officer’s partial initial decision on the
common design, as required by
paragraph 8 of appendix N to part 52,
and 10 CFR 2.405 of subpart D of part
2. The NRC notes that there may be
circumstances where the common
design extends beyond the design
matters covered in a referenced design
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certification or manufactured reactor.
For example, a common design could
reference the use of a specific design
certification and a common ultimate
heat sink. In such circumstances, the
ACRS would issue a common report
limited to the safety matters for the
ultimate heat sink.6
Paragraph 8 of appendix N to part 52
provides that the NRC will designate a
presiding officer to conduct the portion
of the hearing on matters related to the
common design, and that the presiding
officer must issue a partial initial
decision on the common design. As
discussed previously, hearing
procedures for appendix N to part 52
proceedings are set forth in subpart D to
part 2. To avoid duplication and
possible (future) conflicts with subpart
D to part 2, the NRC did not include in
appendix N to part 52 further provisions
addressing the conduct of hearings.
D. Changes to 10 CFR Part 50
1. General Provisions, § 50.2, Definitions
New definitions are added as
conforming changes to § 50.2. A
definition of an applicant is added to
clarify that a person or entity applying
for Commission ‘‘permission or
approval’’ is an applicant. This will
ensure that part 50 requirements for
applicants apply to a person or entity
seeking an NRC approval not
constituting a license, such as a
standard design approval under part 52.
Definitions for license and licensee
are added to clarify that early site
permits and combined licenses under
part 52 are licenses, and that holders of
these types of licenses are licensees for
purposes of part 50.
A definition for prototype plant is
added to describe the type of nuclear
reactor that is the subject of § 50.43(e).
A prototype plant is a licensed nuclear
reactor test facility that is similar to and
representative of the first-of-a-kind
nuclear plant in all features and size,
but may have additional safety features.
The purpose of the prototype plant is to
perform testing of new or innovative
design features for the first-of-a-kind
nuclear plant design, as well as being
used as a commercial nuclear power
facility.
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2. Requirement of License, Exceptions,
§ 50.10, License Required
Section 50.10 addresses the
circumstances under which a license for
6 The site-specific environmental impacts of the
heat sink would ordinarily be addressed in each of
the separate EISs prepared for each application,
inasmuch as the environmental impacts would
differ depending upon factors and characteristics at
each site. Section 7 does not govern the scope of
EISs prepared for common design elements.
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a production or utilization facility is
required, and describes activities which
do not constitute ‘‘construction’’ for
purposes of obtaining a license for a
nuclear power plant. Section 50.10(b)
formerly prohibited a person from
beginning construction of a production
or utilization facility unless a
construction permit has been issued.
Inasmuch as activities constituting
construction (as defined in § 50.10(b))
are authorized under a combined
license, § 50.10(b) is revised to refer to
combined licenses.
Formerly § 52.17(c) authorized an
early site permit applicant to request
authority to perform the activities
allowed under § 50.10(e)(1). The NRC
notes that the regulation did not provide
for the holder of an early site permit to
request authority to conduct
§ 50.10(e)(1) activities after the early site
permit has been issued, and the NRC
does not plan to change the current
restriction. It will conserve the NRC’s
resources to consider the safety and
environmental issues associated with
§ 50.10(e)(1) activities during the
agency’s consideration of the early site
permit application. Late consideration
of these requests after completion of the
NRC’s consideration of the application
could entail substantial diversion of
resources from other application
reviews. For these reasons, the NRC
does not allow an early site permit
holder to request authority to perform
activities allowed under § 50.10(e)(1)
after issuance of the early site permit
(the Commission notes that under
former part 52, early site permit holders
may not seek authority to perform
activities allowed under § 50.10(e)(3)
after issuance of the early site permit).
3. Classification and Description of
Licenses
a. Section 50.23, Construction Permits
Section 50.23 formerly provided that
a construction permit for the
construction of a production or
utilization facility must be issued before
issuance of a license for the facility, and
then only upon ‘‘due completion’’ of the
facility. Section 50.23 is revised to
clarify that if the NRC issues a
combined license for a nuclear power
plant under part 52, the construction
permit and operating license are issued
simultaneously (i.e., are merged into a
‘‘combined license’’ under subpart C of
part 52). This is consistent with Section
185.b of the AEA, which provides the
NRC with explicit statutory authority to
combine a construction permit and an
operating license for a nuclear power
plant into a single combined license.
The Commission notes that § 50.23 is
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not limited to nuclear power plants; it
also allows the NRC to combine, under
Section 161.h of the AEA, a
construction permit and operating
license for production facilities or
utilization facilities other than nuclear
power plants.
4. Applications for Licenses,
Certifications, and Regulatory
Approvals; Form; Contents; Ineligibility
of Certain Applicants
a. Section 50.30, Filing of Application;
Oath or Affirmation
Section 50.30 establishes the NRC’s
general procedural requirements on
filing of applications for licenses
(including construction permits) for
production and utilization facilities.
The NRC is making conforming changes
throughout § 50.30 to include necessary
references to part 52 processes other
than design certification (subpart H of
part 2 governs the filing of standard
design certification applications), viz.,
early site permits, combined licenses,
standard design approvals, and
manufacturing licenses. In addition,
§ 50.30(a) is revised to ensure that the
submission requirements governing
applications (and amendments to these
applications) in § 52.3 apply to part 52
processes other than design
certification.
b. Section 50.33, Contents of
Applications; General Information
Section 50.33 identifies the general
information that must be included in
applications for licenses (including
construction permits) for production
and utilization facilities. Section
50.33(f) requires certain applicants for
nuclear power plant licenses to submit
information sufficient to determine
whether the applicant has the financial
qualifications to carry out, in
accordance with the NRC’s regulations,
the activities for which a license or
permit is sought. Section 50.33 is
revised to require applicants for
combined licenses to submit financial
qualifications information. Financial
qualifications information need not be
submitted by applicants for early site
permits, standard design certifications,
standard design approvals, and
manufacturing licenses. An NRC review
to determine whether an applicant has
adequate financial qualifications to
conduct the activities authorized by an
early site permit would contribute little,
if anything, to providing reasonable
assurance of adequate protection with
respect to early site permit activities.
Ordinarily, an early site permit
authorizes no activities, unless the early
site permit application requested
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authority to conduct the activities
permitted under § 50.10(e)(1). The NRC
has determined that no safety finding
per se is necessary to authorize the
licensee to conduct these activities. The
NRC’s review of a § 50.10(e)(1)
application is focused on siting and
environmental matters.
With respect to a standard design
approval, the argument applies with
even more force, inasmuch as a design
approval authorizes no activities of any
kind, and the finality associated with a
design approval is significantly less
than for an early site permit. The NRC
concludes that no regulatory purpose
appears to be served by a financial
qualifications review for early site
permits and standard design approvals.
The NRC believes that there is little
additional regulatory value in requiring
a financial qualifications review for a
manufacturing license. While it is true
that a lack of sufficient financial
resources could result in inadequate
manufacture of a reactor, under the
NRC’s proposed concept of a
manufacturing license under subpart F
of part 52, each manufactured reactor
cannot be operated until ITAAC
specified in the manufacturing license
are successfully completed by the
licensee authorized to construct the
nuclear power facility using the
manufactured reactor. Successful
completion of the manufactured
reactor’s ITAAC should ensure that any
problems with manufacture attributable
to lack of financial resources of the
manufacturing license holder can be
identified before operation. Moreover,
the licensee authorized to construct the
facility (either under a construction
permit or a combined license) using a
manufactured reactor would have been
subject to a financial qualifications
review. This review should be sufficient
to determine if the applicant has
sufficient financial resources to carry
out facility construction and the
completion of the manufactured
reactor’s inspections, tests, and
acceptance criteria. Finally, the NRC
notes that it does not require the
fabricators of safety-related and
important to safety structures, systems,
and components (SSCs) to be licensed
and subject to a financial qualifications
review. The NRC believes that a holder
of a manufacturing license conducts
activities which appear to be, in large
part, analogous to these current nonlicensed fabricators. Accordingly, the
NRC concludes that a financial
qualifications review of the applicant
for a manufacturing license will not add
significant regulatory value to justify the
cost of such a review.
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Section 50.33(g) addresses
radiological emergency response plans
for State and local government entities
that must be submitted in applications
for operating licenses. The final rule
makes a conforming change to ensure
that applicants for combined licenses
must also submit this information, as
well as applicants for early site permits
who decide under § 52.17(b)(2)(ii) to
seek NRC review and approval of
complete emergency plans. In addition,
§ 50.33(g) provides requirements for the
plume exposure pathway emergency
planning zone (EPZ) and the ingestion
pathway EPZ. The NRC has made a
conforming change to § 50.33(g) in the
final rule to address early site permit
applications that propose major features
of emergency plans describing the EPZs
under 10 CFR 52.17(b)(2)(i). Such
provisions were inadvertently left out of
the proposed rule. For an application for
an early site permit that proposes major
features of the emergency plans
describing the EPZs, the change requires
the descriptions of the EPZs, to meet the
requirements of § 50.33(g). This is
necessary for the NRC to be able to find
that major features describing the EPZs
are acceptable under § 52.18.
Section 50.33(h) formerly required
applicants that propose to construct or
alter a production or utilization facility
to state in their application the earliest
and latest dates for completion of the
construction or alteration. This section
is being revised in the final rule, based
on public comments, to exclude
combined license applicants. The NRC
believes that combined license
applications need not specify the
earliest and latest date for completion of
construction, in light of the amendment
to Section 185 of the AEA that was
made by the Energy Policy Act of 1992.
By adding a new Section 185.b. of the
AEA, the Commission believes that
Congress intended that Section 185.b
supersede Section 185.a of the AEA, so
that the Section 185.a requirements for
‘‘stand-alone’’ construction permits,
such as the need to specify the earliest
and latest date for completion of
construction, do not apply to the
construction permit portion of a
combined license under Section 185.b
of the AEA. Accordingly, the final rule
removes the requirements from
§§ 50.33(h), 52.77, and 52.79(a)(39) that
the combined license application
specify the earliest and latest date for
completion of construction.
Section 50.33(k) currently requires
applicants for operating licenses to
provide a report, as described in § 50.75,
indicating how reasonable assurance
that funds will be available for the
decommissioning process is provided.
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The final rule makes a conforming
change to add a reference to combined
licenses. The content of this report,
reflecting the unique considerations of a
combined license, is addressed
separately in the revision to § 50.75.
c. Section 50.34, Contents of
Construction Permit and Operating
License Applications; Technical
Information
The NRC is changing the heading of
§ 50.34 from Contents of applications;
technical information to read, Contents
of construction permit and operating
license applications; technical
information. Section 50.34(a) currently
provides the requirements for the
technical contents of an application for
a stationary power reactor construction
permit, design certification or combined
license, and § 50.34(b) provides the
requirements for the technical contents
of an application for a stationary power
reactor operating license application.
However, the former version of 10 CFR
part 52 provides requirements for design
certification and combined license
applications that are not consistent with
the current version of § 50.34. For
example, former § 52.47 stated that an
application for design certification must
contain the technical information which
is required of applicants for
construction permits and operating
licenses by part 50 which is technically
relevant to the design and not sitespecific. This would encompass
requirements in both §§ 50.34(a) and (b).
Also, former § 52.79 stated that
applications for combined licenses must
contain the technically relevant
information required of applicants for
an operating license by 10 CFR 50.34,
which are found in § 50.34(b). In
addition to the requirements for
technical information in §§ 50.34(a) and
(b), §§ 50.34(c) through (h) provide
requirements for the contents of
licensing applications related to security
plans, compliance with Three Mile
Island (TMI) related requirements,
combustible gas control, and
conformance with the standard review
plan. Finally, the NRC notes that the
subject of contents of an application is
an administrative matter, rather than a
strictly technical matter. Therefore,
these administrative requirements for
part 52 processes are more properly
located in part 52, rather than in § 50.34.
To provide maximum clarity in the
requirements for the content of each of
the different types of licensing
applications, the NRC is revising § 50.34
to make it applicable to construction
permit and operating license
applications only and to provide
separate sections for the technical
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contents of applications for the other
types of licenses or regulatory approvals
in 10 CFR part 52 (early site permits in
§ 52.17, design certifications in § 52.47,
combined licenses in § 52.79, design
approvals in § 52.137, and
manufacturing licenses in § 52.157). In
its revisions to 10 CFR part 52, the NRC
has brought forward the requirements
from § 50.34 that are applicable to each
of the licensing and approval processes
in 10 CFR part 52. One exception to this
structure is the provisions in § 50.34(f)
related to compliance with TMI related
requirements. Due to the length and
complexity of the requirements in this
paragraph, § 50.34(f) is being amended
to indicate that each applicant for a
design certification, design approval,
combined license, or manufacturing
license under part 52 of this chapter
must demonstrate compliance with any
technically relevant portions of the
requirements in § 50.34(f)(1) through (3),
except for paragraphs (f)(1)(xii),
(f)(2)(ix), and (f)(3)(v). The NRC chose
this approach rather than repeat the
requirements in each of the relevant
sections in part 52. The NRC is adding
the phrase ‘‘except for paragraphs
(f)(1)(xii), (f)(2)(ix), and (f)(3)(v)’’ in the
last sentence of § 50.34(f) based on
public comments. The commenters
pointed out that proposed § 50.34(f) was
inconsistent with proposed
§§ 52.47(a)(17), 52.79(a)(17),
52.137(a)(17), and 52.157(e)(12), which
included the exceptions that are being
added to § 50.34(f) in the final rule.
d. Section 50.34a, Design Objectives for
Equipment To Control Releases of
Radioactive Material in Effluents—
Nuclear Power Reactors; and § 50.36a,
Technical Specifications on Effluents
From Nuclear Power Reactors
Section 50.34a requires that
construction permit and operating
license applications include a
description of the equipment and
procedures for the control of gaseous
and liquid effluents and for the
maintenance and use of equipment
installed in radioactive waste systems.
Section 50.34a also requires these
applications to include an estimate of
(1) the quantity of each of the principal
radionuclides expected to be released
annually to unrestricted areas in liquid
effluents produced during normal
reactor operations; and (2) the quantity
of each of the principal radionuclides of
the gases, halides, and particulates
expected to be released annually to
unrestricted areas in gaseous effluents
produced during normal reactor
operations. In addition, § 50.34a
requires a general description of the
provisions for packaging, storage, and
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shipment offsite of solid waste
containing radioactive materials
resulting from treatment of gaseous and
liquid effluents and from other sources.
Section 50.34a is revised to clarify its
applicability to the 10 CFR part 52
licensing and approval processes.
Section 50.34a applies to combined
licenses by virtue of the provision in
former § 52.83, Applicability of Part 50
Provisions, which states that all
provisions of 10 CFR part 50 and its
appendices applicable to holders of
construction permits and operating
licenses also apply to holders of
combined licenses. Applicants for
design certification are also required to
include the information required by
§ 50.34a in their applications by virtue
of the provision in former
§ 52.47(a)(1)(i), which states that an
application for design certification must
contain the technical information which
is required of applicants for
construction permits and operating
licenses by 10 CFR part 50 which is
technically relevant to the design and
not site-specific. Former appendix O to
10 CFR part 52, Section O.3, explicitly
required applicants for design approvals
to include the applicable technical
information required by § 50.34a.
Finally, former appendix M to 10 CFR
part 52, Section M.1, states that the
provisions in part 50 applicable to
construction permits apply in context,
with respect to matters of radiological
health and safety, environmental
protection, and the common defense
and security, to manufacturing licenses.
Therefore, new provisions in § 50.34a(d)
are adopted to address the applicable
requirements for combined license
applications that parallel the
requirements for an operating license
application. New provisions in
§ 50.34a(e) are adopted to address the
applicable requirements for applications
for design approvals, design
certifications, and manufacturing
licenses to include: (1) A description of
the equipment for the control of gaseous
and liquid effluents and for the
maintenance and use of equipment
installed in radioactive waste systems;
and (2) an estimate of the quantity of
each of the principal radionuclides
expected to be released annually to
unrestricted areas in liquid effluents
produced during normal reactor
operations, and the quantity of each of
the principal radionuclides of the gases,
halides, and particulates expected to be
released annually to unrestricted areas
in gaseous effluents produced during
normal reactor operations.
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e. Section 50.36, Technical
Specifications
Section 50.36(a) currently requires
that each applicant for a license
authorizing operation of a production or
utilization facility include in its
application proposed technical
specifications in accordance with the
requirements of § 50.36. The existing
language in § 50.36(a) encompasses
combined license applicants. However,
applicants for design certification are
also required to include proposed
technical specifications in their
applications by virtue of the provision
in former § 52.47(a)(1)(i) stating that an
application for design certification must
contain the technical information
required of applicants for construction
permits and operating licenses by 10
CFR part 50 that is technically relevant
to the design and not site-specific.
Similarly, applicants for design
approvals are also required to include
proposed technical specifications in
their applications by virtue of the
provision in former appendix O to part
52, Section O.3, which states that the
submittal for review of a standard
design shall include the applicable
technical information under § 50.34 (a)
and (b), as appropriate.
Section 50.36 is revised to clarify that
design certification and manufacturing
license applications must also include
proposed technical specifications. The
new provisions in § 50.36(c) require
each applicant for a design certification
or a manufacturing license to include
proposed generic technical
specifications in its application for the
portion of the plant that is within the
scope of the design certification or
manufacturing license application.
f. Section 50.36a, Technical
Specifications on Effluents From
Nuclear Power Reactors
Section 50.36a(a) requires each
licensee of a nuclear power reactor to
include technical specifications to keep
releases of radioactive materials to
unrestricted areas during normal
conditions, including expected
occurrences, as low as is reasonably
achievable. The former language in
§ 50.36a(a) encompassed combined
license holders. However, applicants for
design certification are also required to
include proposed technical
specifications on effluents in their
applications by virtue of the provision
in current § 52.47(a)(1)(i) which states
that an application for design
certification must contain the technical
information which is required of
applicants for construction permits and
operating licenses by 10 CFR part 50
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which is technically relevant to the
design and not site-specific. In addition,
former appendix M to 10 CFR part 50,
Section M.1, states that the provisions
in part 50 applicable to construction
permits apply in context, with respect to
matters of radiological health and safety
to manufacturing licenses. Therefore,
Section 50.36a(a) is revised to state that
each licensee of a nuclear power reactor
and each applicant for a design
certification or a manufacturing license
will include technical specifications to
keep releases of radioactive materials to
unrestricted areas during normal
conditions, including expected
occurrences, as low as is reasonably
achievable. The proposed rule did not
include the provisions for
manufacturing licenses. However,
proposed § 52.157(e)(18) did require
manufacturing license applicants to
include proposed technical
specifications in accordance with
§ 50.36a. Therefore, it was clearly the
NRC’s intent that the provisions of
§ 50.36a be applicable to manufacturing
license applications and the NRC has
corrected this omission in the final rule.
Some commenters on the 2006
proposed rule identified an additional
conforming change needed in § 50.36a
that the NRC did not make in the
proposed rule. Section 50.36(a)(2)
currently requires that each licensee
submit a report to the Commission
annually that specifies the quantity of
each of the principal radionuclides
released to unrestricted areas in liquid
and in gaseous effluents during the
previous 12 months, including any
other information as may be required by
the Commission to estimate maximum
potential annual radiation doses to the
public resulting from effluent releases.
The NRC has modified this provision to
state that each holder of a combined
license is only required to begin
submitting reports after the Commission
has made the finding under § 52.103(g)
that allows fuel load and operation. This
would apply the requirements in
§ 50.36a consistently for part 50 and
part 52 licensees, because for a part 50
licensee, the annual reporting
requirement is effective only after an
operating license is issued.
The NRC is also making conforming
changes to appendix I to 10 CFR part 50.
These changes parallel the changes to
§§ 50.34a and 50.36a.
g. Section 50.36b, Environmental
Conditions
Section 50.36b authorizes the
Commission to include conditions to
protect the environment in each license
authorizing operation of a production or
utilization facility and each license for
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a nuclear power reactor facility for
which the certification of permanent
cessation of operations required under
§ 50.82(a)(1) has been submitted. These
conditions are to be derived from
information contained in the
environmental report and the
supplement to the environmental report
as analyzed and evaluated in the NRC
record of decision. The conditions must
identify the obligations of the licensee
in the environmental area, including, as
appropriate, requirements for reporting
and keeping records of environmental
data, and any conditions and
monitoring requirement for the
protection of the nonaquatic
environment.
The NRC has made conforming
changes to § 50.36b in the final rule to
address all applicable part 52 licenses.
The changes were made in response to
public comments that highlighted the
need for clarification in § 50.36b. The
NRC provided proposed requirements
for identifying environmental
conditions on early site permits and
combined licenses in the proposed rule
in §§ 51.50(b) and (c). Requirements for
identifying environmental conditions
for construction permits were contained
in former § 51.50 and proposed
§ 51.50(a). The proposed rule stated
that, in an application for a construction
permit, an early site permit, or a
combined license, the applicant shall
identify ‘‘any conditions and monitoring
requirements for protecting the nonaquatic environment, proposed for
possible inclusion in the license as
environmental conditions in accordance
with § 50.36b of this chapter.’’ However,
the NRC neglected to make the
additional conforming changes to
§ 50.36b in the proposed rule. To correct
this oversight, the NRC has modified
§ 50.36b in the final rule to make the
requirements in this section consistent
with the requirements in § 51.50. In
doing so, the NRC has provided separate
paragraphs for imposing conditions
during construction and for imposing
conditions during operation and
decommissioning. Paragraph 50.36b(a)
addresses requirements for imposing
conditions on construction permits,
early site permits, and combined
licenses to protect the environment
during construction. Paragraph
50.36b(b) addresses requirements for
imposing conditions on licenses
authorizing operation and licenses for a
facility in decommissioning to protect
the environment during operation and
decommissioning. These changes
provide consistency in requirements for
environmental conditions across parts
50 and 51.
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h. Section 50.37, Agreement Limiting
Access to Classified Information
Section 50.37 requires that a license
or construction permit applicant agree
in writing that it will not permit any
individual to have access to or any
facility to possess Restricted Data or
classified National Security Information
until the individual and/or facility has
been approved for access under the
provisions of 10 CFR parts 25 and/or 95.
Section 50.37 also requires that this
agreement be part of the application for
a license or construction permit and that
the agreement of the applicant shall be
deemed part of the license or
construction permit, whether stated or
not. The former language of § 50.37
encompassed early site permit,
combined license, and manufacturing
license applicants under 10 CFR part 52
because these products are all licenses.
However, the NRC is revising § 50.37 to
encompass applicants for design
certification and for standard design
approvals under 10 CFR part 52 for
consistency with the changes to 10 CFR
part 25. Part 25 sets forth the NRC’s
requirements governing the granting of
access authorization to classified
information to certain individuals, and
the Commission is making
modifications to part 25 to reflect the
licensing and regulatory approval
processes in part 52. Accordingly, the
Commission is revising § 50.37. Section
50.37 is revised to require that an
applicant for a license, construction
permit, design certification, or design
approval under part 52 agree in writing
that it will not permit any individual to
have access to or any facility to possess
Restricted Data or classified National
Security Information until the
individual and/or facility has been
approved for access under the
provisions of 10 CFR parts 25 and/or 95.
Section 50.37 also requires that this
agreement be part of the application and
be deemed part of the license, or
construction permit, or NRC standard
design approval whether stated or not.
Section 52.54 is revised to include a
new provision which requires that every
standard design certification rule issued
contain a provision that states that, after
the Commission has adopted the final
standard design certification rule, the
applicant will not permit any individual
to have access to or any facility to
possess Restricted Data or classified
National Security Information until the
individual and/or facility has been
approved for access under the
provisions of 10 CFR parts 25 and/or 95.
The NRC believes that these revisions,
along with the complementary changes
to parts 25 and 95, are necessary to
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ensure that access to classified
information is adequately controlled by
all entities applying for NRC licenses,
design certifications, or design
approvals.
5. Standards for Licenses, Certifications,
and Approvals
a. Section 50.40, Common Standards
This section sets forth standards for
issuance of a license. Sections 50.40(a),
(b), and (c) are revised to add
conforming references to the additional
licensing processes issued under 10 CFR
part 52 that are applicable to these
standards.
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b. Section 50.43, Additional Standards
and Provisions Affecting Class 103
Licenses and Certifications for
Commercial Power
The text and heading of this section
are revised to clarify that certain
additional standards and provisions for
class 103 licenses apply to applications
for combined licenses, design
certifications, and manufacturing
licenses issued under part 52, in
addition to applications for construction
permits and operating licenses issued
under part 50. Section 50.43(e) is added
to clarify that the requirements to
demonstrate new safety features by
testing, which were previously set forth
in part 52, apply to applicants for
operating licenses issued under part 50
and applicants for combined licenses,
design certifications, and manufacturing
licenses issued under part 52. This
amendment conforms to the goal of
having reactor safety requirements in
part 50 and procedural requirements in
part 52. Only the requirements in
§ 50.43(e) apply to applications for
design certification. Refer to the generic
discussion on testing requirements for
advanced reactors in Section V.B of this
document.
c. Section 50.45, Standards for
Construction Permits, Operating
Licenses, and Combined Licenses
This section is revised to include the
standards for review of an application to
alter a facility that was constructed
under a combined license, after the
findings under § 52.103(g) of this
chapter are made by the Commission.
Some commenters recommended that
the proposed rule be revised to
reference the applicable requirements in
part 52 rather than the requirements in
10 CFR 50.31 through 50.43 and
claimed that most of those requirements
were moved to part 52 in the proposed
rule. The Commission does not agree
with that claim but does acknowledge
that most of § 50.34 was moved to the
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of the licensing processes in part 52.
Therefore, § 50.45 was revised to set
forth the standards for review of an
application to alter a facility after the
Commission makes the finding under
§ 52.103(g) of this chapter. The
standards for issuance of a combined
license are set forth in § 52.97.
d. Section 50.46, Acceptance Criteria for
Emergency Core Cooling Systems for
Light-Water Nuclear Power Reactors
Section 50.46(a)(3) contains reporting
requirements for changes to or errors in
emergency core cooling system (ECCS)
evaluation models. Conforming
references to design approvals, design
certifications, and licenses issued under
part 52 were made to § 50.46, so that the
NRC will be notified of changes to or
errors in acceptable evaluation models,
or the application of such models, that
were used in licenses, certifications, and
approvals issued under part 52.
e. Section 50.47, Emergency Plans,
§ 50.54(gg), and Appendix E to Part 50,
Emergency Planning and Preparedness
for Production and Utilization Facilities
Section 50.47 and appendix E to 10
CFR part 50 contain emergency
planning requirements for nuclear
power plants. Prior to this rulemaking,
these regulations did not clearly address
early site permit or combined license
applicants or holders. Accordingly, the
NRC is making a number of changes in
these regulations. Section 50.47(a)(1)
states that no initial operating license
for a nuclear power reactor will be
issued unless a finding is made by the
NRC that there is reasonable assurance
that adequate protective measures can
and will be taken in the event of a
radiological emergency, and that no
finding under § 50.47 is necessary for
issuance of a renewed nuclear power
reactor operating license. The NRC is
revising § 50.47(a)(1) to include
provisions to address combined licenses
and early site permits which include
either complete and integrated plans or
major features of the emergency plans.
The NRC inadvertently left out
provisions to address early site permits
that include major features of the
emergency plans in the proposed rule
and a new provision has been added to
address applicants in the final rule.
The NRC is making some additional
changes to § 50.47(a)(1) in the final rule.
Proposed § 50.47(a)(1)(ii) stated that
‘‘Except as provided in paragraph (e) of
this section, no initial combined license
under part 52 of this chapter will be
issued unless a finding is made by the
NRC that there is reasonable assurance
that adequate protective measures can
and will be taken in the event of a
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radiological emergency.’’ In the final
rule, the NRC is removing the phrase
‘‘except as provided in paragraph (e)’’
because paragraph (e) does not address
issuance of the combined license, but,
rather, addresses the Commission
finding under § 52.103(g). Likewise, the
NRC is making a change to paragraph (e)
of this section in the final rule to
remove the reference to paragraph (a) of
this section.
Finally, the NRC is removing the
statement in proposed § 50.47(a)(1)(iii)
that ‘‘No finding under this section is
necessary for issuance of a renewed
early site permit.’’ The NRC included
this provision in the proposed rule to be
consistent with the existing requirement
for operating licenses. However, upon
further consideration, the NRC
concludes that the basis for this
exclusion for an operating license and
for a combined license does not apply
to an early site permit. The original
license renewal rule, which limited the
scope of matters to be addressed in the
renewal proceeding, was based upon a
determination that the regulatory
process maintains and updates the
licensing basis for operating licenses,
that matters like the state of the
emergency preparedness plans need not
be addressed in license renewal. The
bases for the license renewal rule
described the process, in each
substantive regulatory area, for
maintaining and updating the current
licensing basis. This logic does not
directly apply to emergency
preparedness information submitted in
an early site permit application, because
there is no maintenance or update
requirement for the early site permit.
Therefore, the NRC cannot exclude the
need to address emergency
preparedness in an early site permit
renewal proceeding.
Section 50.47(c)(1) provides a process
for operating license applicants that fail
to meet the applicable standards of
§ 50.47(b). The NRC is revising
§ 50.47(c)(1) to clarify that this process
is applicable to combined license
applicants as well.
Section 50.47(d) formerly provided
that no NRC or Department of
Homeland Security (DHS) review,
findings, or determinations concerning
the state of offsite emergency
preparedness or the adequacy of and
capability to implement State and local
or utility offsite emergency plans are
required before issuance of an operating
license authorizing only fuel loading or
low-power testing and training (up to 5
percent of the rated power). Section
50.47(d) further stated that a license
authorizing fuel loading and/or lowpower testing and training may be
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issued after a finding is made by the
NRC that the state of onsite emergency
preparedness provides reasonable
assurance that adequate protective
measures can and will be taken in the
event of a radiological emergency and
provides the standards by which the
NRC will base such a finding. The NRC
is adding a new § 50.47(e) to provide
essentially parallel provisions for a
combined license holder by stating that
a combined license holder may not load
fuel or operate except as provided in
accordance with appendix E to part 50
and, because of the nature of the
combined license process, the NRC is
adding new § 50.54(gg) that would add
a condition to all combined licenses.
This is necessary to account for the fact
that the combined license will already
be issued at the time of the first full or
partial participation exercise.
The NRC’s findings regarding the state
of emergency preparedness for a
combined license holder will be taken
into account in the NRC’s review under
§ 52.103(g). The NRC will make its
determination by judging whether the
licensee has met the acceptance criteria
in the combined license for the
inspections, tests, and analyses related
to the conduct of the first full or partial
participation exercise under paragraph
IV.F.2.a of appendix E to part 50.
Paragraph 50.54(gg) states that if,
following the conduct of the exercise
required by paragraph IV.F.2.a of
appendix E to part 50, DHS identifies
one or more deficiencies in the state of
offsite emergency preparedness, the
holder of a combined license may
operate at up to 5 percent of rated
thermal power only if the Commission
finds that the state of onsite emergency
preparedness provides reasonable
assurance that adequate protective
measures can and will be taken in the
event of a radiological emergency.
Paragraph 50.54(gg) also provides the
standards by which the NRC will base
such a finding.
The NRC is revising appendix E to
part 50 to conform to the changes
proposed for §§ 50.47 and 50.54. The
introduction to appendix E to part 50
states that each applicant for an
operating license is required by
§ 50.34(b) to include in the final safety
analysis report plans for coping with
emergencies. The NRC is adding a
parallel statement for combined license
applicants, and a statement that an early
site permit applicant may submit
emergency plans. The final rule also
makes additional conforming changes to
the second paragraph of the
introduction that were inadvertently
overlooked in the proposed rule. Similar
modifications are proposed in Section
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III of appendix E to part 50 regarding the
content of final safety analysis reports
and site safety analysis reports for an
early site permit. The NRC is making a
correction to Section III in the final rule
to replace references to the early site
permit application with references to
the site safety analysis report. The NRC
is also adding a statement that the site
safety analysis report for an early site
permit which proposes major features
must address the relevant provisions of
10 CFR 50.47 and 10 CFR part 50,
appendix E, within the scope of
emergency preparedness matters
addressed in the major features. This is
consistent with the requirements in
§ 52.17(b).
In Section IV of appendix E to part 50,
the NRC is modifying paragraph F.2.a,
to address combined licenses in
addition to operating licenses.
Paragraph F.2.a currently provides
requirements regarding the conduct of
full participation exercises and states
that a full participation exercise shall be
conducted within 2 years before the
issuance of the first operating license for
full power of the first reactor. Paragraph
F.2.a also requires that, if the full
participation exercise is conducted
more than 1 year before issuance of an
operating licensee for full power, an
exercise which tests the licensee’s
onsite emergency plans shall be
conducted within 1 year before issuance
of an operating license for full power.
The NRC is designating the
requirements for operating licenses as
paragraph F.2.a.i, and adding a new
paragraph F.2.a.ii that contains the
requirements for combined licenses.
Paragraph F.2.a.ii states that, for a
combined license, the first full
participation exercise must be
conducted within 2 years of the
scheduled date for initial loading of fuel
and operation under § 52.103. Paragraph
F.2.a.ii also requires that, if the first full
participation exercise is conducted
more than 1 year before the scheduled
date for initial loading of fuel and
operation under § 52.103, an exercise
which tests the licensee’s onsite
emergency plans must be conducted
within 1 year before the scheduled date
for initial loading of fuel and operation
under § 52.103. The modifications
further state that, if DHS identifies one
or more deficiencies in the state of
offsite emergency preparedness as the
result of the first full participation
exercise, or if the NRC finds that the
state of emergency preparedness does
not provide reasonable assurance that
adequate protective measures can and
will be taken in the event of a
radiological emergency, the provisions
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49401
of § 50.54(gg) will apply, as previously
discussed.
The NRC is adding a new paragraph
IV.F.2.a.iii to appendix E to part 50 to
require that, if the applicant has an
operating reactor at the site, an exercise,
either full or partial participation, be
conducted for each subsequent reactor
constructed on the site. This exercise
may be incorporated in the exercise
requirements of paragraphs (2)(b) and
(2)(c) of Section IV.F. If DHS identifies
one or more deficiencies in the state of
offsite emergency preparedness as the
result of this exercise for the new
reactor, or if the NRC finds that the state
of emergency preparedness does not
provide reasonable assurance that
adequate protective measures can and
will be taken in the event of a
radiological emergency, the provisions
of § 50.54(gg) apply just as they do for
the first reactor at a site. This new
provision is desirable because of the
nature of ITAAC for emergency
preparedness requirements. The
emergency preparedness ITAAC,
specifically ITAAC that will be
demonstrated through an exercise,
provide the necessary reasonable
assurance for programs and facilities
associated with the yet-unbuilt reactor.
Recent agreements between the NRC
and external stakeholders on emergency
preparedness ITAAC are based on the
understanding that ITAAC on the
emergency preparedness exercise would
serve to demonstrate various aspects of
emergency preparedness (e.g., programs
and facilities) that did not warrant their
own specific/detailed ITAAC. For
example, there is no ITAAC for
determining whether an adequate
staffing roster exists for the technical
support center or emergency offsite
facility, but its existence and adequacy
could be demonstrated during an
exercise. Therefore, appendix E to part
50 requirements for emergency
preparedness exercises must be
included for the current concepts
regarding emergency preparedness
ITAAC to be viable. With regard to
subsequent reactors, those aspects of an
exercise which address currently
untested (i.e., unexercised) aspects of
emergency preparedness for the
proposed new reactor must be
addressed in new emergency
preparedness ITAAC for the subsequent
reactor. If various generic exerciserelated aspects of emergency
preparedness for the site have been
previously addressed and satisfied, then
there would be no ITAAC for those
emergency preparedness aspects for
subsequent reactors.
The NRC is also modifying Section V
of appendix E to part 50, which states
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that no less than 180 days before the
scheduled issuance of an operating
license for a nuclear power reactor or a
license to possess nuclear material, the
applicant’s detailed implementing
procedures for its emergency plan shall
be submitted to the Commission.
Paragraph V also requires that licensees
submit any changes to the emergency
plan or procedures to the NRC within 30
days of these changes. The NRC is
clarifying that paragraph V is also
applicable to COL holders by stating
that they must submit their detailed
implementing procedures for their
emergency plans to the NRC no less
than 180 days before the scheduled date
for initial loading of fuel. The wording
of this requirement has been changed
slightly in the final rule. In the proposed
rule, this provision required that COL
holders submit their detailed
implementing procedures for their
emergency plans to the NRC no less
than 180 days before the date that the
Commission authorizes fuel load and
operation under § 52.103. The NRC has
modified the provision to make the
target date 180 days before scheduled
date for initial loading of fuel because
this will be a known date whereas the
licensee would not know the date that
the Commission will make the
§ 52.103(g) finding. This change is also
consistent with other requirements in
appendix E that are tied to the
scheduled date for initial fuel load.
f. Section 50.48, Fire Protection
Section 50.48(a)(1) is revised to clarify
that holders of an operating license
issued under part 50 and a combined
license issued under part 52 must have
a fire protection plan. Section
50.48(a)(4) is added to clarify that
applications for design approvals,
design certifications, and manufacturing
licenses issued under part 52 must meet
the fire protection design requirements
set forth in general design criterion 3 of
appendix A to part 50.
rwilkins on PROD1PC63 with RULES2
g. Section 50.49, Environmental
Qualification of Electric Equipment
Important to Safety for Nuclear Power
Plants
Section 50.49(a) is revised to clarify
that these programmatic requirements
apply to applicants for and holders of
operating licenses issued under part 50
and combined licenses and
manufacturing licenses under part 52.
h. Section 50.54, Conditions of Licenses;
and § 50.55, Conditions of Construction
Permits, Early Site Permits, Combined
Licenses, and Manufacturing Licenses
Section 50.54 sets forth various
provisions that are deemed to be
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conditions ‘‘in every license issued,’’
while § 50.55 sets forth the provisions
deemed to be conditions of every
construction permit. In making the
conforming changes to these regulations
to reflect part 52, the NRC has decided
to maintain this dichotomy. Conditions
applicable to part 52 processes which
are either licenses or prerequisites to
licenses, and do not address activities
analogous to construction for which a
construction permit license is required
under the AEA, are addressed in
§ 50.54. By contrast, conditions
applicable to part 52 processes which
address construction activities, or
activities analogous to construction for
which a construction permit license is
required under the AEA, are covered in
§ 50.55. Combined licenses represent a
special case, inasmuch as they address
both construction and operation. The
NRC addresses combined licenses by
placing the conditions applicable only
to construction in § 50.55, which
indicates that these conditions are
applicable until the date that the
Commission makes the finding under
§ 52.103(g). Conditions which are
applicable during construction and
operation or only during operation are
set forth in § 50.54. The NRC is revising
the introductory paragraph of § 50.54 to
refer to combined licenses, and to
exclude manufacturing licenses from its
provisions. The NRC is making
revisions to § 50.54 in the final rule
based on public comments. In the
proposed rule, the NRC did not
distinguish which provisions in § 50.54
are applicable only during operation
from those that are applicable during
both construction and operation. In the
final rule, the NRC has revised the
introductory paragraph to indicate
which provisions are applicable only
after the Commission makes the finding
under § 52.103(g). In making these
revisions, the NRC determined that the
provisions that need to be applied
during both construction and operation
are paragraphs (a) through (h), (o), (p),
(q), (t), (v), and (aa) through (ee). All of
these provisions have some
requirements that will be implemented
prior to the Commission finding under
§ 52.103(g).
In addition, the NRC is adding
paragraphs (r) and (u) to the list of
provisions in the introduction that are
not applicable to combined licenses.
This is because paragraph (r) only
applies to research and test reactor
facilities and paragraph (u) was only
applicable for 60 days after the
amendment to § 50.54 that added
paragraph (u). Finally, the NRC is also
revising the first sentence of the
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introduction to indicate that paragraphs
(r) and (gg) do not apply to nuclear
power reactor operating licenses. In the
proposed rule, the introduction stated
that they did not apply to operating
licenses, which would have included
research and test reactor operating
licenses.
The NRC is revising § 50.54(a)(1) to
indicate that the quality assurance (QA)
requirements applicable to operation, as
described in a combined license
holder’s SAR, become effective 30 days
before the scheduled date for the initial
loading of fuel.
The NRC is revising § 50.54(i-1) to
indicate its applicability to combined
licenses. Specifically, § 50.54(i-1)
requires that within 3 months after the
date that the Commission makes the
finding under § 52.103(g) for a
combined license, the licensee shall
have in effect an operator requalification
program that must, as a minimum, meet
the requirements of § 55.59(c) of this
chapter.
The NRC has added changes to
§ 50.54(p) and (q) in the final rule. The
changes to paragraph (p) are being made
to include references to appropriate part
52 sections in addition to the existing
references to part 50 sections. The
change to paragraph (q) is being added
to include a statement that, for
combined licenses, the requirement to
follow and maintain in effect emergency
plans which meet the standards in
§ 50.47(b) and the requirements in
appendix E of part 50 is only applicable
after the Commission makes the finding
under § 52.103(g). However, the
remainder of the requirements in
paragraph (p) apply from the time the
combined license is issued (e.g.,
requirements to retain records of
emergency plan changes). This is
consistent with the change made to the
introductory paragraph of § 50.54
discussed earlier in this section.
The NRC is adding a new § 50.54(gg).
These revisions are discussed with
related requirements in Section IV.D.4.f
of this document, ‘‘Section 50.47,
Emergency plans, § 50.54(gg), and
appendix E to part 50.’’
Although the NRC generally views
§ 50.55 as the appropriate section in part
50 for specifying the conditions
applicable to construction permits and
part 52 processes analogous to
construction permits, the NRC does not
believe that all of the conditions in
§ 50.55 should apply equally to all of
the part 52 processes. Accordingly, the
introductory text to § 50.55 is revised to
specify which paragraphs apply to a
construction permit, early site permit,
combined license, and manufacturing
license.
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Sections 50.55(a) and (b) of the March
2006 proposed rule would have
required a combined license to state the
earliest and latest dates for completion
of construction or modification, and to
provide for forfeiture of the combined
license if the construction or
modification is not completed by the
stated date. The Commission has
reconsidered this position and has
decided to remove this requirement
from the final rule. The statutory
requirement for a construction permit to
state the earliest and latest date for
completion of construction is now
contained in Section 185.a of the AEA.
The combined license, by contrast, is
address in Section 185.b. The
Commission believes that in the absence
of specific language regarding the
restriction in paragraph a. applicable to
combined licenses in paragraph b., the
combined license is not subject to any
of the statutory restrictions in paragraph
a. The NRC believes that the provisions
of Section 185 of the AEA do not apply
to a manufacturing license, inasmuch as
a manufacturing license is not, per se,
a construction permit. Accordingly, no
earliest and latest date for completion of
manufacture would be required to be
stated in a manufacturing license.
Section 50.55(c) makes the license
conditions in § 50.54 also apply to
construction permits, unless otherwise
modified. In the proposed rule, the NRC
revised this paragraph to add a reference
to combined licenses. However, upon
further consideration, the NRC has
determined that no change to § 50.55(c)
is necessary because the introduction to
§ 50.54 outlines which provision in that
section apply to combined licenses.
Section 50.55(e) addresses the
obligation of holders of construction
permits and their contractors and
subcontractors, to report defects
constituting a substantial safety hazard.
These requirements, which implement
Section 206 of the ERA, as amended, are
comparable to the requirements in 10
CFR part 21. As discussed with respect
to the NRC’s changes to part 21, the
NRC is retaining the current regulatory
structure, whereby persons and entities
engaged in activities constituting
construction (and their contractors and
subcontractors) are subject to § 50.55(e),
and persons and licensees who are
authorized to operate a nuclear power
plant (and their contractors and
subcontractors) are subject to part 21.
Inasmuch as a combined license under
part 52 authorizes both construction and
operation, a combined license holder
would be subject to the reporting
requirements in § 50.55(e) from the date
of issuance of the combined license
until the Commission makes the finding
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under § 52.103. Thereafter, the
combined license holder would be
governed by the reporting requirements
in part 21. The manufacture of a nuclear
power reactor under a manufacturing
license is the functional equivalent of
construction. Accordingly, the NRC’s
view is that the holder of a
manufacturing license should be subject
to reporting under § 50.55(e). Standard
design approvals under subpart E to part
50 (former appendix M to part 52) and
design certifications under subpart B of
part 52 are not directly associated with
construction, and the NRC believes that
their reporting should be addressed
under part 21. Accordingly, the NRC is
revising § 50.55(e)(1) to provide that the
reporting requirements in § 50.55(e)
apply to a holder for a combined license
(until the NRC makes the finding under
§ 52.103(g)), and a manufacturing
license under part 52. As discussed
further in Section J on part 21 of this
document, early site permits do not
authorize ‘‘construction’’ or its
functional equivalent. Therefore, early
site permits are subject to the
requirements of part 21 rather than
§ 50.55(e) under the final rule.
Section 50.55(f) sets forth the NRC’s
requirements with respect to
compliance with the QA requirements
in 10 CFR part 50, appendix B, and
implementation of the construction
permit holder’s QA program as
described in its SAR. Comparable
provisions applicable to holders of
operating licenses are contained in
§ 50.54(a); requirements governing the
SAR’s description of the QA program
are contained in § 50.34. A detailed
discussion of all changes related to QA
requirements can be found in Section
IV.D.13.b of this document.
standards set out in 10 CFR part 50 as
it applies to applications for
construction permits and operating
licenses for nuclear power plants, and
as those standards are technically
relevant to the design proposed for the
facility. Although former appendix O to
part 52 does not explicitly require
applicants for design approvals to
comply with the requirements of
§ 50.55a, the NRC is requiring design
approval holders to comply with
§ 50.55a because the NRC believes that
the requirements for a design approval
should be the same as the requirements
for design certification, given that the
reviews performed by the NRC staff for
the two products are essentially
identical. Finally, appendix M to part
52, Section M.1, states that the
provisions in part 50 applicable to
construction permits apply in context,
with respect to matters of radiological
health and safety, environmental
protection, and the common defense
and security, to manufacturing licenses.
Therefore, the NRC is modifying
§ 50.55a to state that each combined
license for a utilization facility is subject
to the conditions in § 50.55a, but is only
subject to the conditions in §§ 50.55a(f)
and (g) after the NRC makes the finding
under § 52.103. The modifications to
§ 50.55a also state that each
manufacturing license, design approval,
and design certification application is
subject to the conditions in §§ 50.55a(a),
(b)(1), (b)(4), (c), (d), (e), (f)(3), and
(g)(3), which are the provisions related
to nuclear power facility design.
i. Section 50.55a, Codes and Standards
Section 50.55a provides requirements
relating to codes and standards for
construction permits and operating
licenses for boiling or pressurized
water-cooled nuclear power facilities.
The NRC is revising § 50.55a to clarify
how the regulations in § 50.55a apply to
approvals, certifications, and licenses
issued under 10 CFR part 52. Section
50.55a formerly applied to combined
licenses by virtue of the provision in
current § 52.83, which stated that all
provisions of 10 CFR part 50 and its
appendices applicable to holders of
construction permits and operating
licenses also apply to holders of
combined licenses. Also, § 50.55a
formerly applied to design certifications
by virtue of the provision in former
§ 52.48, which states that design
certification applications will be
reviewed for compliance with the
This section presents a change
process for information contained in the
FSAR. Section 50.59(b) is revised to
clarify that this change process is
applicable to holders of operating
licenses issued under part 50 and
combined licenses issued under part 52.
If the combined license references a
design certification rule, then the
information in the design control
document is controlled by the change
process in the applicable design
certification rule. Section 50.59(d)(2) is
revised to conform the frequency that
summary reports are submitted for
holders of combined licenses with the
frequency set forth in the design
certification rules. Section 50.59(d)(3) is
revised to clarify that the requirement
for maintaining records applies to
holders of operating licenses issued
under part 50 and combined licenses
issued under part 52.
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j. Section 50.59, Changes, Tests, and
Experiments
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k. Section 50.61, Fracture Toughness
Requirements for Protection Against
Pressurized Thermal Shock Events
This section is revised to clarify that
the fracture toughness requirements
apply to an operating license for a
pressurized water reactor issued under
part 50 or a combined license for a
pressurized water reactor issued under
10 CFR part 52.
recommended that NRC should not
require implementation prior to fuel
load when not all systems will have
been placed in service. The NRC agrees
with this comment and has deleted the
proposed revision to § 50.65(c). Under
the final rule, licensees are required to
implement the requirements of this
section by the time that initial fuel
loading has been authorized.
l. Section 50.62, Requirements for
Reduction of Risk From Anticipated
Transients Without Scram (ATWS)
Events for Light-Water-Cooled Nuclear
Power Plants
Paragraph (d) of § 50.62 provides
implementation requirements for the
requirements of the section. This
paragraph is revised to indicate that
these implementation requirements only
apply to light-water-cooled nuclear
power plant operating licenses issued
before the effective date of this final
rule. Section 50.62 is revised to require
each light-water-cooled nuclear power
plant operating license application
submitted after the effective date of this
final rule to submit information in its
final safety analysis report
demonstrating how it will comply with
paragraphs (c)(1) through (c)(5) of
§ 50.62. Similarly, the NRC is adding
provisions to §§ 52.47, 52.79, 52.137,
and 52.157 requiring that applicants for
standard design certifications, combined
licenses, standard design approvals, and
manufacturing licenses include the
information required by this section in
their final safety analysis reports.
6. Inspections, Records, Reports,
Notifications
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m. Section 50.63, Loss of All Alternating
Current Power
Conforming changes are made to this
section to clarify that the requirements
for station blackout apply to
applications for construction permits,
combined licenses, design approvals,
design certifications, manufacturing
licenses, and operating licenses.
n. Section 50.65, Requirements for
Monitoring the Effectiveness of
Maintenance at Nuclear Power Plants
This section presents the
requirements for monitoring the
effectiveness of maintenance at nuclear
power plants. Paragraph 50.65(a) is
revised to clarify that holders of
operating licenses issued under part 50
and combined licenses issued under
part 52 must comply with the
requirements in this section. In the
proposed rule, § 50.65(c) was revised to
specify that, for new licenses issued
after the effective date of this regulation,
the requirements of this section must be
implemented 30 days before the initial
fuel loading of the reactor. Commenters
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a. Section 50.70, Inspections
Section 50.70(a) requires that each
licensee and each holder of a
construction permit allow inspection,
by duly authorized representatives of
the Commission, of its records,
premises, activities, and of licensed
materials in possession or use, related to
the license or construction permit as
may be necessary to effectuate the
purposes of the AEA. The language in
§ 50.70(a) encompasses combined
license holders and manufacturing
license holders because they are
licensees. In addition, the provision in
former § 52.83, states that all provisions
of 10 CFR part 50 and its appendices
applicable to holders of construction
permits and operating licenses also
apply to holders of combined licenses.
Also, former Section M.1 of appendix M
to part 52, states that the provisions in
part 50 applicable to construction
permits apply in context, with respect to
matters of radiological health and safety,
environmental protection, and the
common defense and security, to
manufacturing licenses. Section 50.70(a)
is revised to clarify that these inspection
requirements also apply to holders of
early site permits under 10 CFR part 52.
An early site permit is a partial
construction permit and therefore
should be subject to the same inspection
requirements as a construction permit.
In addition, the NRC is clarifying that
the inspection requirements also apply
to applicants for licenses, construction
permits, and early site permits. It is
common for applicants to perform
activities related to NRC regulations
before issuance of the license or permit
for which they are applying and it has
been the NRC’s practice to inspect these
activities whenever they are performed.
Therefore, the modification to require
that the inspection requirements in
§ 50.70(a) apply to applicants is simply
a codification of the NRC’s current
practices.
Section 50.70(b)(1) requires that each
licensee and each holder of a
construction permit provide rent-free
office space for the exclusive use of NRC
inspection personnel. The existing
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language in this provision encompasses
combined license holders and
manufacturing license holders. Section
50.70(b)(2) provides requirements
regarding the space to be provided for
a site with a single power reactor facility
licensed under 10 CFR part 50 and for
sites containing multiple power reactor
units. The NRC is revising § 50.70(b)(2)
to clarify that these requirements also
apply to sites for combined license
holders under 10 CFR part 52 and to
facilities issued manufacturing licenses
under 10 CFR part 52.
b. Section 50.71, Maintenance of
Records, Making of Reports
Section 50.71 establishes the NRC’s
requirements for maintenance and
retention of records and reports, and
updating of FSARs. Section 50.71(a)
requires each licensee and each holder
of a construction permit to maintain all
records and make all reports as may be
required by license, or by the NRC’s
regulations. The former language does
not apply to non-licensees, such as
holders of standard design approvals
and applicants for standard design
certifications, even though it would
appear that these requirements should
Accordingly, the NRC is revising
§ 50.71(a) to make its provisions
applicable to holders of standard design
approvals and all applicants for design
certification during the period of NRC
consideration of the application for
design certification, and those
applicants for design certification whose
designs are certified via rulemaking in
accordance with subpart B of 10 CFR
part 52.
Section 50.71(c) specifies that the
default record retention period (i.e., the
period that applies if a record retention
period is not specified by the regulation
requiring the record) ends when the
NRC ‘‘terminates the facility license.’’ A
manufacturing license is not a ‘‘facility’’
license, inasmuch as subpart F of part
52 is limited to the manufacture of
reactors, not a ‘‘facility.’’ Finally, some
licenses (e.g., early site permits and
manufacturing licenses) may either be
terminated by the NRC, or ‘‘expire’’ as
a matter of law at the end of their term.
Accordingly, the NRC is revising
§ 50.71(c) to establish the records
retention period and to properly refer to
manufacturing licenses, early site
permits, and construction permits.
Section 50.71(e) establishes the
updating requirements for the FSAR,
including the information that must be
included in each update. The former
regulation, however was deficient in
two respects. First, it did not address
the updating requirements for combined
license applicants and holders. Second,
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the regulation, if applied to
manufacturing licenses under subpart F
of part 52, imposed unnecessary
regulatory burden with respect to
periodic updating.
Accordingly, the NRC is revising
§ 50.71(e) to specify the FSAR updating
requirements for combined license
applicants and holders. In addition,
current § 50.71(f) is redesignated as
§ 50.71(g), and a new § 50.71(f) is added.
Section 50.71(e)(3)(iii) is added to
contain the provisions applicable to
combined license holders during the
period of time from docketing of the
application to the Commission finding
under § 52.103(g). The update frequency
during this period is established as
annually, which is consistent with
requirements in Section X.B.3.b of the
design certification rules in appendices
A through D of part 52 for combined
license holders that reference those
rules. After the Commission finding
under § 52.103(g), the frequency would
be governed by § 50.71(e)(4), as for other
operating reactors.
Section 50.71(f) is revised to require
the holder of the manufacturing license
to update the FSAR to reflect any
modifications to the design of the
reactor authorized to be manufactured
which have been approved by the NRC
under § 52.171, or any new analyses
requested to be performed by the NRC.
Periodic updating of an FSAR for a
manufacturing license is not required by
§ 50.71(f), inasmuch as the NRC’s
concept for a manufacturing license is
for the design of the reactor authorized
to be manufactured to be stable with no
changes except as specifically approved
by the NRC as necessary for adequate
protection to public health and safety or
common defense and security, or to
ensure compliance with the NRC’s
requirements in effect at the time of
issuance of the manufacturing license.
The provision in § 50.71(f) requiring the
FSAR for a manufacturing license to be
updated to reflect new safety analyses
required by the NRC is analogous to the
existing updating requirement in
§ 50.71(e). This assures that new
analyses performed to demonstrate the
continuing adequacy of the unchanged
manufactured reactor design are
appropriately reflected in the FSAR.
Paragraph (g), formerly (f), is being
revised to add reference to § 52.110(a)(1)
for permanent cessation of operation for
plants licensed under part 52.
Finally, paragraph (h) is being added
to 50.71. This paragraph contains
requirements for licensees to maintain
and upgrade the PRA periodically
throughout the plant life. These
provisions apply only to COLs under
part 52, but are included in part 50 in
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this section covering maintenance of
records and making of reports,
consistent with the Commission’s
practice elsewhere in development of
the requirements for the part 52
processes.
These new requirements are a
culmination of the Commission’s
interest in use of risk-informed
processes as articulated in its 1995
Policy Statement (‘‘Use of Probabilistic
Risk Assessment Methods in Nuclear
Activities: Final Policy Statement,’’ (60
FR 42622; August 16, 1995)).In the
original part 52 rule, each design
certification holder was required to
include as part of the application a
design-specific PRA. The Commission
has been engaged in an effort to improve
PRA quality through support and
endorsement of consensus standards on
PRA methods.
In the proposed rule published in
March 2006, the Commission included
a specific request for comment
(Question 10, ‘‘New Requirements for
Periodic Updates to the PRA’’—see
section IV of this document) about part
52 licensees periodically updating the
PRA throughout the life of the facility,
on a schedule similar to that for FSAR
updates. Several commenters noted that
the proposed rule did not include a
frequency for updating the PRA. These
commenters stated that they believed
that PRA update frequency should be
addressed in guidance rather than
regulations. These commenters
indicated a frequency of once every two
operating cycles would be reasonable
and consistent with existing
requirements in 10 CFR 50.69(e). After
considering the comments received, the
Commission has decided to require
combined license holders to maintain
and upgrade a PRA to meets endorsed
standards over the lifetime of the
facility. To implement this decision,
new requirements are being placed in
§ 50.71(h).
Paragraph (h)(1) requires each holder
of a combined license, by the time of the
scheduled fuel load date for the facility,
to develop a plant-specific PRA. The
PRA is to be both level 1 and level 2 and
must cover those modes of operation
and initiating events for which NRCendorsed consensus standards are in
effect one year prior to that date. Level
1 refers to the identification and
quantification of sequences leading to
the onset of core damage. Level 2 refers
to identification and quantification of
severe accident progression and
containment response. Additional
information about scope and quality of
PRA to meet these provisions will be
addressed in the NRC documents
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49405
endorsing the standards, or in the
standards themselves.
The one year time period was chosen
to allow time for the licensee to develop
and upgrade its PRA and conduct peer
review prior to the date when the PRA
must be completed (i.e., by the
scheduled date for initial fuel load). The
scheduled fuel load date was selected
because the COL holder chooses this
date, and thus is in a position to
determine when the ‘‘one-year prior’’
requirement comes into effect. Note that
this provision does not require that this
PRA be submitted to the NRC for review
and approval. The need for any such
submittal or review would be
determined by any risk-informed
application for which the licensee might
wish to use this PRA, such as in support
of licensing actions.
Paragraph (h)(2) requires the COL
holder to maintain the PRA until
permanent cessation of operations
under § 52.110(a). The Commission
intends PRA maintenance to be
consistent with how it is defined in the
American Society of Mechanical
Engineers (ASME) ‘‘Standard for
Probabilistic Risk Assessment for
Nuclear Power Plant Applications’’
(ASME–RA–Sb–2005), that is ‘‘the
update of the PRA models to reflect
plant changes, such as modifications,
procedure changes or plant
performance.’’ No specific frequency is
defined in the rule for such
maintenance; the Commission expects
licensees to follow the ASME (or other
consensus body) guidance on this
aspect.
The paragraph further provides that
the PRA must be upgraded every four
years, to cover initiating events and
operational modes contained in NRCendorsed consensus standards in effect
one year prior to each required upgrade.
The Commission intends PRA upgrade
to be consistent with how it is defined
in consensus standards, such as ASME–
RA–Sb–2005, that is, ‘‘the incorporation
into a PRA model of a new methodology
or significant changes in scope or
capability.’’ If no new standards are
issued during a four-year upgrade cycle,
licensees would not be required to
upgrade their PRAs; however, the
requirement to maintain the PRA would
still be in effect. It should also be noted
that there may be situations where a
PRA upgrade is needed more frequently
than the four year cycle, as for instance
to support a new risk-informed
application.
Finally, paragraph (h)(3) specifies that
each holder of a combined license shall,
no later than the date on which the
licensee submits an application for a
renewed license, upgrade the PRA to
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cover all modes and all initiating events.
This requirement is not premised on the
existence of NRC-approved consensus
standards, and an all-mode, all-initiator
PRA must be developed even if
standards do not yet exist. The
requirement to develop and maintain
such a PRA by the time of license
renewal application is intended only to
establish a timing requirement for
completing the upgrade of the PRA, and
does not have any implications on the
current requirements for license
renewal. The upgraded PRA is not an
element of any (i.e., past, present, or
future) review or approval of a license
renewal application.
In implementing these new
requirements, it is the NRC’s
expectation that industry stakeholders
will work with the NRC and appropriate
codes and standard setting bodies to
continually upgrade the relevant codes
and standards, identify potential issues,
resolve problems, and create relevant
guidance to assist in periodically
improving the quality and
comprehensiveness of the PRA.
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c. Section 50.72, Immediate Notification
Requirements for Operating Nuclear
Power Reactors
Section 50.72 currently requires
holders of operating licenses under part
50 for nuclear power plants to notify the
NRC Operations Center via the
Emergency Notification System of the
declaration of any of the emergency
classes specified in the licensee’s
approved emergency plan and of certain
non-emergency events. The NRC’s
regulatory interest in these events also
extends to nuclear power plants
operating under a combined license
under subpart C of part 52, but the
former language did not impose the
notification requirements on combined
license holders. Accordingly, in a
conforming change in the final rule, the
NRC is extending the notification
requirements to holders of combined
licenses under part 52 after the
Commission has made the finding under
§ 52.103(g). The NRC did not include a
conforming change to this section in the
proposed rule. However, based on
public comments, the NRC is including
the change in the final rule to make it
clear that the requirements of § 50.72
only apply to a combined license holder
after the Commission makes the finding
under § 52.103(g). The NRC is not
extending the notification requirements
to other part 52 processes because the
events to be reported under the existing
rule concern events which can only
occur upon fuel load and operation, and
the remaining part 52 licensing and
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regulatory approval processes do not
authorize fuel load or operation.
d. Section 50.73, Licensee Event Report
System
Section 50.73 requires holders of
operating licenses under part 50 for
nuclear power plants to submit licensee
event reports (LERs) on the occurrence
of certain operating events to the NRC.
LERs facilitate the NRC’s oversight of
operating nuclear power plants, by
alerting the NRC to the occurrence and
underlying causes of events having
potential safety implications. The NRC’s
regulatory interest in these events also
extends to nuclear power plants
operating under a combined license
under subpart C of part 52, but the
former language did not impose the LER
requirement on combined license
holders. Accordingly, in a conforming
change, the NRC is extending the LER
reporting requirements to holders of
combined licenses under part 52 after
the Commission has made the finding
under § 52.103(g). The final rule does
not extend the LER requirement to other
part 52 processes, because the events to
be reported under the existing rule
concern events which can only occur
upon fuel load and operation, and the
remaining part 52 licensing and
regulatory approval processes do not
authorize fuel load or operation.
e. Section 50.75, Reporting and
Recordkeeping for Decommissioning
Planning
The requirements in § 50.75 are
intended to ensure that entities who
construct and ultimately operate a
nuclear power plant will have sufficient
funds at the end of the operational life
of the plant to complete the
decommissioning of the plant. Section
50.75 requires a nuclear power plant
operating license application to address
the predicted costs of decommissioning,
provide financial assurance by one of
the means specified in the regulation,
and submit evidence that one or more
of these means has been established.
Section 50.75 also requires the operating
license holder to update the cost
estimates for decommissioning on an
annual basis, and to submit reports to
the NRC every 2 years describing, inter
alia, any adjustments to the amount of
funds collected annually to reflect any
changes in projected decommissioning
cost. When a plant is within 5 years of
its projected end of its operation, the
reports must be submitted annually, and
a site-specific decommissioning cost
estimate must be submitted. Some of
these requirements are directed at the
two phase licensing process in 10 CFR
part 50, in which the NRC issues a
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construction permit followed by an
operating license. These requirements
are not well-suited to the combined
license process under part 52. For
example, requiring the combined
license applicant to comply with the
current requirement in § 50.75(b)(4) that
the operating license applicant submit a
copy of the financial instrument
obtained to satisfy the requirements of
§ 50.75(e), would place a more stringent
requirement on the combined license
applicant, inasmuch as that applicant
would be required to fund
decommissioning assurance at an earlier
date as compared with the operating
license applicant.
To address these discrepancies, the
NRC is revising § 50.75 to address
decommissioning funding assurance for
combined licenses. Under the final rule,
the combined license applicant must
submit a decommissioning report as
required by § 50.33(k), but it need not
obtain a financial instrument to fund
decommissioning or to submit a copy to
the NRC. Instead, under § 50.75(b)(1)
and (4), the combined license
application must contain a certification
that the financial assurance will be
provided no later than 30 days after the
NRC publishes notice in the Federal
Register under § 52.103(a). See
§ 50.75(b)(1).
The proposed rule would have
required the combined license holder to
submit, by March 31 of each year until
the date that the NRC authorizes fuel
load under § 52.103(g), an updated
certification of the information required
by paragraph (b)(1). The proposed rule
also would have required the combined
license holder to submit, no later than
30 days after the Commission publishes
notice in the Federal Register under
§ 52.103(a), a certification that financial
assurance is being provided in the
relevant amount together with a copy of
the financial instrument obtained to
satisfy the requirements of § 50.75(e).
Once the Commission has made the
finding under § 52.103, the proposed
rule would have required the combined
license holder to be subject to the
reporting and updating requirements as
an operating license holder under part
50, including the requirements
applicable when the plant is within 5
years of the projected end of operation.
A commenter objected to the annual
reporting requirement, arguing that an
annual update during the construction
period would serve no purpose and is
unnecessary and unduly burdensome.
The commenter proposed that the
holder be allowed to adjust or update
the original certification at the time
construction is complete and the plant
is ready to begin operation. Upon
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further consideration, the Commission
has decided to modify the final rule by
eliminating the requirement for annual
reports, and instead requiring the
updating reports 2 years and 1 year
before the date scheduled for initial
loading of fuel load (consistent with the
schedule required by § 52.99(a)). The
Commission’s objective is to have
sufficient time to evaluate the projected
costs of decommissioning, and any
licensee-proposed changes in the
financial assurance mechanism for
funding before fuel is loaded into the
reactor and operation commences. This
will allow the Commission to take any
necessary regulatory action before fuel
loading and commencement of
operation.
The final rule requires that no later
than 30 days after the Commission
publishes notice in the Federal Register
under § 52.103(a), the combined license
holder must submit a report to the NRC.
The report must contain a certification
that financial assurance is being
provided in an amount specified in the
licensee’s most recent updated
certification (i.e., the certification
provided 1 year before the scheduled
date for initial loading of fuel, in
accordance with the first sentence of
§ 50.75(e)(3)). The certification must
include a copy of the financial
instrument obtained to provide
decommissioning funding assurance.
The requirements in paragraph (f)(1) of
§ 52.103(a), which are applicable to the
combined license holder after the
Commission has made the finding under
§ 52.103, are adopted in the final rule
without change from the proposed rule.
The § 50.75 decommissioning funding
requirements do not apply to an
applicant for, and holder of, a
manufacturing license under part 52.
The NRC did not intend, when it first
adopted § 50.75, to subject holders of
manufacturing licenses to the
requirements of that section. It is clear
from the words of former § 50.33(k)(1)
that the rule applies only to applications
for operating licenses for production
and utilization facilities. A
manufacturing license by itself does not
authorize either fuel load or operation,
which are the activities necessitating the
expenditure of funds for
decommissioning. Therefore, there is no
need for a holder of a manufacturing
license, who does not intend to operate
the reactor being manufactured to
provide funding.
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7. US/IAEA Safeguards Agreement
a. Section 50.78, Installation
Information and Verification
Since 1980, the U.S./International
Atomic Energy Agency (IAEA)
Safeguards Agreement has allowed
IAEA inspection and verification
activities at U.S. facilities that the IAEA
selects from the U.S. Eligible Facilities
List. The safeguards agreement is
implemented under the Nuclear NonProliferation Treaty, which provides
assurance that all nuclear materials
declared to be in peaceful use are not
diverted to potential use in nuclear
explosives. Although 10 CFR part 75
contains most of the NRC requirements
intended to implement the installation,
inspection, and verification provisions
of the Safeguards Agreement with IAEA,
§ 50.78 requires each holder of a
construction permit to submit certain
information on Form N–71, permit
verification by representatives of the
IAEA, and take any other action
necessary to implement the Safeguards
Agreement. Inasmuch as combined
licenses authorize construction of a
nuclear power plant at a fixed site, the
provisions of § 50.78 should also apply
to a holder of a combined license under
part 52. Accordingly, § 50.78 is revised
to specify that holders of combined
licenses must, if requested by the NRC,
submit installation information on Form
N–71, permit verification of that
information by the IAEA, and take other
action as may be necessary to
implement the Safeguards Agreement,
in the manner set forth in § 75.6, and
§§ 75.11 through 75.14.
8. Transfers of Licenses—Creditors’
Rights—Surrender of Licenses
a. Section 50.80, Transfer of Licenses
Section 50.80 implements Sections
101 and 184 of the AEA, which require
Commission approval for the transfer of
a license for a production or utilization
facility, including a nuclear power
reactor. Section 50.80(a) explicitly refers
to transfers of a ‘‘license for a
production or utilization facility
* * *,’’ which would include
construction permits under part 50, as
well as all licenses and permits issued
under part 52. However, to explicitly
recognize the applicability of § 50.80(a)
to both permits under parts 50 and 52
and all licenses under part 52, § 50.80(a)
is revised to explicitly refer to permits
under parts 50 and 52, and licenses
under part 52. The proposed rule would
have only made these clarifying
revisions. A commenter on the proposed
rule stated that some of the
requirements in § 50.80 are not relevant
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to transfers of an ESP. The NRC agrees,
and has revised the final rule to specify
which criteria are applicable to transfer
of an ESP. Specifically, paragraph
(b)(1)(ii) requires an application for
transfer of an ESP to include as much
of the information described in §§ 52.16
and 52.17 with respect to the identity
and technical qualifications of the
proposed transferee as would be
required by those sections if the
application were for an initial license.
This change removes the requirement
for the applicant for transfer of an ESP
to address financial qualifications since
this is not required of an initial ESP
applicant. In addition, this change
removes the provision that the NRC may
require additional information as part of
an ESP transfer with respect to data on
proposed safeguards against hazards
from radioactive materials and the
applicant’s qualifications to protect
against such hazards. Information on
these subject matters is not relevant to
an ESP transfer, inasmuch as an ESP
does not authorize the holder to possess
radioactive material.
The NRC declines to adopt the
suggestion of a commenter who
suggested that the statement of
considerations clarify when a transfer of
an ESP is necessary. The NRC’s revision
to § 50.80 is a conforming change to a
procedural regulation, the process by
which the NRC processes and
determines a transfer of a license.
Section 50.80 does not, by itself, specify
the circumstances for which a license
transfer is necessary; it simply addresses
what procedures must be followed if a
license transfer request is received.
Therefore, the NRC does not believe that
it is necessary or desirable to provide
such guidance in the context of this
rulemaking.
b. Section 50.81, Creditor Regulations
Section 50.81 implements Section 184
of the AEA, which requires the consent
of the Commission for the creation of
any mortgage, pledge or other lien upon
any Commission-licensed facility or
special nuclear material. To ensure that
the reach of § 50.81 is as broad as the
statutory requirement, the NRC is
revising the definition of license and
facility. The definition of license in this
section is revised to explicitly refer to
all licenses under 10 CFR, and early site
permits under part 52. The definition of
facility is revised to add a new
paragraph which explicitly refers to an
early site permit under part 52, and a
reactor manufactured under a
manufacturing license under part 52.
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9. Amendment of License or
Construction Permit at Request of
Holder
a. Section 50.90, Application for
Amendment of License or Construction
Permit; section 50.91, Notice for Public
Comment; State Consultation; and
section 50.92, Issuance of Amendment
Sections 50.90, 50.91, and 50.92
govern the procedures and criteria for
NRC consideration and issuance of
amendments to licenses and
construction permits. The regulations
do not clearly address early site permits,
combined licenses, or manufacturing
licenses. Accordingly, the NRC is
making a number of changes in these
regulations.
Section 50.90 provides that applicants
for amendment of a license or
construction permit must file their
application with the NRC as described
in § 50.4, following the form prescribed
for the original application. Although
the term, license, as amended in § 50.2
includes combined licenses,
manufacturing licenses, and early site
permits under part 52, § 50.92 is revised
to explicitly refer to these part 52
licenses to eliminate any confusion with
respect to the applicability of this
section to part 52 licenses. A similar
change is made in the introductory
paragraph of § 50.91.
Sections 50.92 and 50.91(a)(4)
implement the Commission’s authority
under Section 189 of the AEA to
dispense with the advance publication
of a Federal Register document
requesting a hearing with respect to
license amendments, and to make
operating license and combined license
amendments immediately effective
upon issuance, if the NRC finds that the
amendment involves no significant
hazards consideration. The NRC is
revising § 50.92(c) to clarify that,
consistent with Section 189 of the AEA,
the NRC may make a no significant
hazards consideration determination for
amendments of combined licenses
under part 52. Combined licenses are
explicitly mentioned in Section
189.a.(2)(A) of the AEA with respect to
immediate effectiveness following a
Commission determination of a no
significant hazards consideration. In
addition, a combined license merges
into a single license the authority
otherwise contained in a construction
permit and an operating license, and the
language of Section 189.a.(1)(A) of the
AEA which refers to both amendments
of construction permits and operating
licenses, also applies to amendments of
combined licenses.
Finally, § 50.92(a) is revised to
provide that a separate application for a
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construction permit is not required even
where a holder of a combined license or
a manufacturing license must seek a
license amendment because of a
material alteration. There is no safety or
regulatory benefit in requiring the
licensee to concurrently submit an
application for a new construction
permit in addition to a license
amendment, inasmuch as NRC review of
the alteration is assured.
10. Revocation, Suspension,
Modification, Amendment of Licenses
and Construction Permits, Emergency
Operations by the Commission
a. Section 50.100, Revocation,
Suspension, Modification of Licenses,
Permits, and Approvals for Cause
Section 50.100 is revised to explicitly
address the Commission’s authority to
suspend, modify, or revoke any
standard design approval under subpart
E of parts 50 or 52 for any material false
statement in the application, or because
of any statement in any report, record,
inspection, or condition revealed by the
application, or by other means, which
would warrant the NRC to refuse to
grant the design approval on an original
application. The former language of
§ 50.100, which is retained as paragraph
(a) in the final rule, applied to any
license or any license or construction
permit issued under part 50 for any
material false statement in the
application for the license or permit, or
because of any statement in any report,
record, inspection, or condition
revealed by the application, or by other
means, which would warrant the NRC
to refuse to grant a license on an original
application, or for failure to construct or
operate a facility in accordance with the
applicable license or permit. While this
language applies to early site permits,
combined licenses and manufacturing
licenses, by virtue of their status as
licenses under the AEA, it does not
clearly apply to standard design
approvals as these are not licenses.
Nonetheless, the Commission possesses
authority to modify, suspend or revoke
the regulatory approvals. Accordingly,
the NRC is revising this section to add
a reference to a standard design
approval.
The final rule is different than the
proposed rule in several ways. A
reference to part 50 is added in the
clause governing revocations,
suspensions, and modifications of
licenses. The word, ‘‘provided * * *,’’
is revised to read ‘‘provided,
however,* * *.’’ Finally, a reference to
a combined license is added to the
clause stating that a failure to meet the
timely completion of proposed
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construction or alteration is subject to
§ 50.55(b) (which is also revised in this
final rulemaking to make its provisions
applicable to combined licenses).
11. Backfitting
a. Section 50.109, Backfitting
The backfit rule, 10 CFR 50.109,
provides certain protection to nuclear
power plant licensees against changes in
the NRC requirements and NRC staff
positions on those requirements. Prior
to the final rule, the backfitting
provisions in § 50.109 applied to
standard design approvals, construction
permits, and operating licenses, but did
not address combined licenses or
manufacturing licenses. Part 52 contains
special backfitting requirements on
early site permits, design certification
rules, but prior to this rulemaking,
neither § 50.109 or part 52 addressed
backfitting of a combined license,
although the NRC recognizes that
backfitting restraints for an early site
permit and a design certification rule
would apply to a combined license
referencing either or both. To address
these gaps in backfitting, and to clarify
the application of special backfitting
provisions, § 50.109(a)(1) is revised by
establishing the date that backfitting
protection begins for a manufacturing
license, a construction permit for a
duplicate design license, and a
combined license. Moreover, with
respect to a part 50 construction permit,
a part 50 operating license, and a part
52 combined license, § 50.109 is revised
by listing the specific backfitting
restrictions that apply if an early site
permit, standard design approval, or
standard design certification rule is
referenced, or if a nuclear power reactor
manufactured under a part 52
manufacturing license is used.
In the statement of considerations for
the 2006 proposed rule, the Commission
asked whether, instead of conforming
the language of § 50.109 to reflect the
licensing and regulatory approval
processes in part 52, the Commission
should adopt a general backfitting
provision, analogous to § 50.109, in part
52. Commenters either expressed no
opinion on the matter, or otherwise
indicated that they did not have a
preference. Accordingly, the
Commission has decided to revise
§ 50.109 to include the conforming
changes, rather than adopting a
backfitting provision in part 52.
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12. Enforcement
a. Section 50.120, Training and
Qualification of Nuclear Power Plant
Personnel
This section sets forth the
requirements for training and qualifying
nuclear power plant personnel. In a
conforming change, the NRC is revising
§ 50.120 to add applicants for and
holders of combined licenses as being
subject to this provision.
13. Appendices
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a. Appendix A to Part 50—General
Design Criteria for Nuclear Power Plants
The first paragraph of the
Introduction to appendix A to part 50 is
revised to clarify that the general design
criteria in appendix A to part 50 apply
to applications for combined licenses,
design approvals, design certification,
and manufacturing licenses, as well as
for construction permits. Also, General
Design Criterion (GDC) 19 of appendix
A to part 50, which sets forth
requirements for a main control room in
a nuclear power plant, is revised to
clarify that the radiation protection
requirements in GDC 19 for applications
filed after January 10, 1997, apply to
design approvals and manufacturing
licenses issued under part 52, in
addition to design certifications and
combined licenses.
b. Appendix B to Part 50—Quality
Assurance Criteria for Nuclear Power
Plants and Fuel Reprocessing Plants
Appendix B to part 50 states that
every applicant for a construction
permit is required to include in its
preliminary safety analysis report a
description of the quality assurance
program to be applied to the design,
fabrication, construction, and testing of
the SSCs of the facility and every
applicant for an operating license is
required to include, in its FSAR,
information pertaining to the managerial
and administrative controls to be used
to assure safe operation. The NRC is
revising appendix B to part 50 to clarify
that these requirements also apply to
early site permits, design approvals,
design certifications, combined licenses,
and manufacturing licenses under 10
CFR part 52. Specifically, the
introduction to appendix B to part 50 is
revised to state that every applicant for
a combined license is required by the
provisions of § 52.79 to include in its
FSAR a description of the quality
assurance program applied to the
design, and to be applied to the
fabrication, construction, and testing of
the SSCs of the facility and to the
managerial and administrative controls
to be used to assure safe operation. The
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introduction also states that, for
applications submitted after the
effective date of the final rule, every
applicant for an early site permit is
required by the provisions of § 52.17 to
include in its site safety analysis report
a description of the quality assurance
program applied to site activities related
to the design, fabrication, construction,
and testing of the SSCs of a facility or
facilities that may be constructed on the
site. The introduction states that every
applicant for a design approval or
design certification is required by the
provisions of §§ 52.137 and 52.47,
respectively, to include in its FSAR a
description of the quality assurance
program applied to the design of the
SSCs of the facility. Finally, the
introduction states that every applicant
for a manufacturing license is required
by the provisions of 10 CFR 52.157 to
include in its FSAR a description of the
quality assurance program applied to
the design, and to be applied to the
manufacture of, the SSCs of the reactor.
The wording in appendix B of part 50
and in the related provisions in the
contents of application sections in 10
CFR part 52 is modified slightly in the
final rule to reflect that some activities
have already occurred when the
application is submitted (e.g., design of
SSCs for design certification applicants).
Therefore, instead of requiring that the
application describe the QA program
‘‘to be applied’’ to these activities, the
final rule requires that the application
describe the QA program ‘‘applied’’ to
these activities, since they have already
occurred.
The NRC is maintaining the current
regulatory structure for requirements
that implement appendix B to part 50
whereby QA for construction activities
is governed by § 50.55(f), and QA for
operation is governed by § 50.54(a).
Because a combined license under part
52 authorizes both construction and
operation, a combined license holder
should be subject to the QA
requirements in § 50.55(f) from the date
of issuance of the combined license
until the Commission makes the finding
under § 52.103(g) that allows the
licensee to load fuel and operate.
Thereafter, the combined license holder
should be governed by the QA
requirements in § 50.54(a). The
manufacture of a nuclear power reactor
under a manufacturing license is the
functional equivalent of construction.
Accordingly, the NRC is revising
§ 50.55(f) to refer to holders of
manufacturing licenses under part 52.
Early site permits under subpart A
precede construction and are considered
partial construction permits. Hence the
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NRC believes that they should be
subject to QA under § 50.55(f), and
§ 50.55(f) is revised accordingly.
Appendix B to part 50 was formerly
applicable to combined licenses under
the provisions of § 52.83, which states
that all provisions of 10 CFR part 50 and
its appendices applicable to holders of
operating licenses also apply to holders
of combined licenses. Appendix B to
part 50 formerly applied to design
certifications by virtue of the provision
in former § 52.48, which stated that
design certification applications will be
reviewed for compliance with the
standards set out in 10 CFR part 50 as
they apply to applications for
construction permits and operating
licenses for nuclear power plants, and
as those standards are technically
relevant to the design proposed for the
facility. Former appendix O to part 52,
Section O.3, required applicants for
design approvals to include the
information required by §§ 50.34(a) and
(b), as appropriate, and stated that the
information required by § 50.34(a)(7) (a
description of the quality assurance
program and a discussion of how the
applicable requirements of appendix B
to part 50 will be satisfied), shall be
limited to the QA program to be applied
to the design, procurement and
fabrication of the SSCs for which design
review has been requested. Appendix B
to part 50 formerly applied to
manufacturing licenses by virtue of the
provision in former appendix M to part
52, Section M.1, which stated that the
provisions in part 50 applicable to
construction permits apply in context,
with respect to matters of radiological
health and safety, environmental
protection, and the common defense
and security, to manufacturing licenses.
Early site permits are considered
partial construction permits, therefore,
the NRC believes that they should be
subject to the QA requirements of
appendix B to part 50. Section 52.39,
with certain specific exceptions,
requires the Commission to treat matters
resolved in an early site permit
proceeding as resolved in making
findings for issuance of a construction
permit, operating license, or combined
license. Because of this finality,
conclusions made during the early site
permit phase will be relied upon for use
in subsequent design, construction,
fabrication, and operation of a reactor
that might be constructed on the site for
which an early site permit is issued.
Therefore, the NRC believes that the
level of quality used to control activities
related to safety-related SSCs should be
equivalent in the early site permit and
combined license phases. For these
reasons, applicants must apply quality
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controls to each early site permit
activity associated with the generation
of design information for safety-related
SSCs that meet the criteria in appendix
B to part 50. Therefore, the NRC is
revising appendix B to part 50 to make
it applicable to early site permits.
c. Appendix C to Part 50—A Guide for
the Financial Data and Related
Information Required To Establish
Financial Qualifications for
Construction Permits and Combined
Licenses
Section 182.a of the AEA requires an
applicant for a license for a production
or utilization facility to submit
information in its application * * * ‘‘as
the Commission, regulation, may
determine to be necessary to decide
such of the technical and financial
qualifications of the applicant * * * as
the Commission may deem appropriate
for the license.’’ The NRC has long
determined the need for non-utility
applicants for nuclear power plant
construction permits and operating
licenses to establish their financial
qualifications (see 10 CFR 50.33(f)), and
has set forth the specific information on
financial qualifications to be provided
by applicants for construction permits
in appendix C to part 50. Inasmuch as
holders of combined licenses under part
52 are authorized to perform the same
construction activities with respect to a
nuclear power plant as a holder of a
construction permit under part 50, the
NRC believes that applicants for
combined licenses should be subject to
the requirements of appendix C to part
50. Accordingly, the title of appendix C
is revised to make clear the applicability
of this appendix to applicants for
combined licenses. This change
constitutes a conforming change to the
revision of § 50.33.
With the exception of manufacturing
licenses, none of the other regulatory
processes under part 52, e.g., early site
permits, standard design certifications,
and standard design approvals,
authorize any activities constituting
‘‘construction’’ under the AEA and the
Commission’s regulations.7 Therefore,
the final rule does not refer to early site
permits, design certifications, or design
approvals under part 52. With respect to
a reactor manufacturing license, the
NRC does not believe that a financial
qualifications review is necessary for
several reasons. A financial
qualifications review at the
manufacturing license stage would
7 Although early site permit applicants may seek
the authority to conduct activities allowed under 10
CFR 50.10(e)(1) (but not activities allowed under
§ 50.10(e)(3), see § 52.17(c)), these activities are not
considered ‘‘construction.’’
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appear to be redundant to the financial
qualifications review that is already
necessary at the construction permit and
operating license stages, or combined
license stage. Sufficient safety and
quality assurance reviews, including the
use of ITAAC in the case of a combined
license, should be sufficient to address
any adverse impacts on safety as the
result of inadequate financial resources
to properly manufacture the reactor.
Furthermore, the NRC notes that
manufacture of a reactor is, in many
respects, no different than fabrication of
components and systems by third party
vendors, who are not required to obtain
an NRC license and demonstrate
financial qualifications. There seems to
be no regulatory value to mandate a
financial qualifications review of
manufacturing license applicants, when
this type of review is not conducted by
the NRC for fabricators of nuclear power
plant systems and components.
d. Appendix E to Part 50—Emergency
Planning and Preparedness for
Production and Utilization Facilities
See discussion in Section V.D.4.f of
this document.
e. Appendix I to Part 50—Numerical
Guides for Design Objectives and
Limiting Conditions for Operation To
Meet the Criterion ‘‘as Low as is
Reasonably Achievable’’ for Radioactive
Material in Light-Water-Cooled Nuclear
Power Reactor Effluents
The Commission is revising appendix
I to part 50 to conform to the changes
in §§ 50.34a and 50.36a which are being
made as part of this final rule.
Specifically, a statement is added in
Section I of appendix I to part 50,
stating that §§ 52.47, 52.79, 52.137, and
52.157 provide that applications for
design certification, combined license,
design approval, or manufacturing
license, respectively, shall include a
description of the equipment and
procedures for the control of gaseous
and liquid effluents and for the
maintenance and use of equipment
installed in radioactive waste systems.
In addition, Section II of appendix I to
part 50 is revised to state that the guides
on design objectives set forth in
appendix I to part 50 may be used by
an applicant for a combined license as
guidance in meeting the requirements of
§ 50.34a(d) or by an applicant for a
design approval, a design certification,
or a manufacturing license as guidance
in meeting the requirements of
§ 50.34a(e). Section IV of appendix I to
part 50 is revised to state that the guides
on limiting conditions for operation for
light-water-cooled nuclear power
reactors in appendix I to part 50 may be
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used by an applicant for an operating
license or a design certification or
combined license, or a licensee who has
submitted a certification of permanent
cessation of operations under
§ 50.82(a)(1) or § 52.110 as guidance in
developing technical specifications
under § 50.36a(a) to keep levels of
radioactive materials in effluents to
unrestricted areas as low as is
reasonably achievable. Finally, Section
V of appendix I to part 50 is revised to
state that the guides for limiting
conditions for operation set forth in
appendix I are applicable to any
application filed on or after January 2,
1971, for a construction permit for a
light-water-cooled nuclear power
reactor, or a design certification, a
combined license, or a manufacturing
license for a light-water-cooled nuclear
power reactor under part 52. Note that
the NRC added the phrase ‘‘for a lightwater-cooled nuclear power reactor’’ to
Section V in the final rule. This phrase
was inadvertently left out of the
introduction to Section V in the
proposed rule. The NRC did not intend
to change the applicability of appendix
I in this rulemaking and is, therefore,
correcting this omission in the final
rule. The NRC has also removed the
conforming change it had proposed to
paragraph A.3 of the Concluding
Statement of Position of the Regulatory
Staff (Docket–RM–50–2) Guides on
Design Objectives for Light-WaterCooled Nuclear Power Reactors in
appendix I. The design objectives in this
staff position are only applicable to
those light-water-cooled nuclear power
reactors that applied for a construction
permit before January 2, 1971 (per
Appendix I, Section V, B.2.). Because
part 52 did not exist before 1971, the
proposed change is unnecessary.
f. Appendix J to Part 50—Primary
Reactor Containment Leakage Testing
for Water-Cooled Power Reactors
Section 50.54(o) provides a condition
for all operating licenses for watercooled power reactors that primary
reactor containments must meet the
containment leakage test requirements
set forth in appendix J to part 50. These
test requirements provide for
preoperational and periodic verification
by test of the leak-tight integrity of the
primary reactor containment, and
systems and components which
penetrate containment of water-cooled
power reactors, and establish the
acceptance criteria for these tests. The
purpose of the tests are to assure that
leakage through the primary reactor
containment systems and components
penetrating primary containment shall
not exceed allowable leakage rate values
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as specified in the technical
specifications or associated bases, and
periodic surveillance of reactor
containment penetrations and isolation
valves is performed so that proper
maintenance and repairs are made
during the service life of the
containment, and systems and
components penetrating primary
containment. The Commission is
revising appendix J to clarify that these
requirements also apply to combined
licenses under 10 CFR part 52. This is
consistent with former § 52.83, which
stated that all provisions of 10 CFR part
50 and its appendices applicable to
holders of operating licenses also apply
to holders of combined licenses.
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g. Appendices M and O to Part 50
[Removed]
The NRC has removed appendices M
and O from 10 CFR part 50. Appendix
M provided for issuance of a license
authorizing the manufacture of a
nuclear power reactor to be
incorporated into a nuclear power plant
under a construction permit and
operated under an operating license at
a different location from the place of
manufacture. Appendix O addressed the
approval of standard designs for nuclear
power reactors. These appendices were
transferred to 10 CFR part 52 when it
was first issued (54 FR 15372; April 18,
1989). However, the NRC failed to
remove those appendices from 10 CFR
part 50, though the NRC intended to do
so (see 54 FR 15385; April 18, 1989).
h. Appendix S to Part 50—Earthquake
Engineering Criteria for Nuclear Power
Plants
Appendix S to part 50 provides
earthquake engineering criteria for
nuclear power plants and applies to
applicants for a design certification or
combined license under part 52 or a
construction permit or operating license
under part 50. The final rule revises
appendix S to clarify that the
requirements in appendix S also apply
to applicants for design approvals and
manufacturing licenses issued under 10
CFR part 52. Although former appendix
O to part 52 did not explicitly require
applicants for design approvals to
comply with the requirements of
appendix S, the NRC is requiring design
approval holders to comply with
appendix S to part 50 because the NRC
believes that the requirements for a
design approval should be the same as
the requirements for a design
certification, given that the reviews
performed by the NRC staff for the two
products are essentially identical.
Finally, appendix S formerly applied to
manufacturing licenses by virtue of
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former appendix M to part 52, Section
M.1, which stated that the provisions in
part 50 applicable to construction
permits apply in context, with respect to
matters of radiological health and safety,
environmental protection, and the
common defense and security, to
manufacturing licenses. Therefore, the
Commission is revising the General
Information section of appendix S to
part 50 to state that the appendix
applies to applicants for a design
certification, design approval, combined
license, or manufacturing license under
10 CFR part 52 or a construction permit
or operating license under 10 CFR part
50. The NRC also made conforming
changes to the Introduction, paragraph
(a) to appendix S to part 50, and added
definitions for design approval and
manufacturing license to Section III of
appendix S to part 50, to be consistent
with the definitions in proposed part 52.
E. Change to 10 CFR Part 1
1. Section 1.43, Office of Nuclear
Reactor Regulation
Section 1.43 describes the
responsibilities of the Office of Nuclear
Reactor Regulation (NRR), which
includes the development and
implementation of regulations, policies,
programs and procedures for the receipt,
possession or ownership of source,
byproduct and special nuclear material
that is used or produced at nuclear
power plants. Inasmuch as power plants
may be licensed under part 52 as well
as part 50, § 1.43(a)(2) is revised to
clarify that NRR has authority over the
development and implementation of
regulations, policies, programs and
procedures for the receipt, possession or
ownership of source, byproduct and
special nuclear material that is used or
produced at nuclear power plants
licensed under part 52. In addition, a
correction has been made to reference
part 54, to clarify that NRR has the same
authority with respect to renewed
operating licenses for nuclear power
plants.
F. Changes to 10 CFR Part 2
1. Section 2.1, Scope
The statement of scope for part 2 is
revised by adding a reference to
rulemaking and standard design
approvals. Previously, the scope
statement did not mention rulemakings,
even though subpart H of part 2 applied
to rulemakings, nor did it mention
standard design approvals even though
the NRC processed applications for
design approvals in accordance with the
procedures in part 2. Accordingly, the
change in the statement of scope for part
2 correctly reflects the applicability of
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its procedures to both rulemaking and
the processing of standard design
approvals.
2. Section 2.4, Definitions
The definitions of contested
proceeding, license, and licensee, are
revised in part 2 by adding conforming
references, as appropriate, to the
licensing processes in part 52. The
revised definition of contested
proceeding clarifies that contested
proceedings include those involving
permits, such as early site permits and
construction permits. The revised
definition of license, ensures that early
site permits and construction permits,
as well as part 52 combined licenses
and manufacturing licenses, are
considered to be licenses for purposes of
part 2. Similarly, the revised definition
of licensee ensures that holders of early
site permits and construction permits,
as well as combined licenses and
manufacturing licenses, are considered
to be licensees for purposes of part 2.
3. Section 2.100, Scope of Subpart
This section is revised by adding
conforming references to issuance of a
standard design approval under subpart
E of part 52.
4. Section 2.101, Filing of Application
This section, which governs the
procedures for, and the timing and
content of applications, has been
revised in several respects. Paragraphs
(a)(1), (a)(2), the introductory paragraph
of (a)(3), paragraph (a)(3)(iii), and
paragraph (a)(4) are revised by adding
conforming references to combined
licenses, early site permits, and
standard design approvals. The
Commission notes that the former
language of § 2.101 already applied to
combined licenses, as well as early site
permits, inasmuch as they are both
licenses. Nonetheless, consistent with
the revisions to the definitions of license
and licensee, § 2.101 has been revised to
explicitly refer to early site permits, as
applicable.
In response to public comment on the
proposed rule, paragraph (a)(5) of
§ 2.101 and paragraph (a–1) are revised
to allow applicants for combined
licenses—as well as applicants for
construction permits as provided under
this section—to submit applications in
parts. Paragraph (a)(5) of the final rule
allow applicants for combined licenses
and construction permits to submit an
application in two parts, with one part
containing the environmental report
required under § 50.30(f) if the
application is for a construction permit
or § 52.80(b) if the application is for a
combined license. The other part must
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contain the information required by
§§ 50.34(a) and 50.34a if the application
is for a construction permit, or § 52.79
and § 52.80(a) if the application is for a
combined license. In addition, the part
that is filed first must contain the
information required by § 50.33,
§ 50.34(a)(1) if the application is for a
construction permit, § 52.79(a)(1) if the
application is for a combined license,
and § 50.37. There are no considerations
unique to combined licenses which
would weigh against allowing a
combined license applicant to submit a
two part application under paragraph
(a)(5) of § 2.101. Accordingly, the
Commission is adopting this change in
the final rulemaking. Inasmuch as the
revisions are to the Commission’s rules
of procedure and practice, the
Commission may adopt them in final
form without further notice and
comment, under the rulemaking
provisions of the APA, 5 U.S.C.
553(b)(A).
Paragraph (a–1) of § 2.101 allows
applicants for combined licenses, as
well as applicants for construction
permits, to submit an application in
parts to allow for early consideration
and a presiding officer’s partial initial
decision on those site suitability matters
for which the applicant seeks NRC
resolution. The provisions governing
early consideration of site suitability
issues in a combined license proceeding
are set forth in paragraph (a–1)(2).
Under this paragraph, a combined
license application may be submitted in
three parts, with the first part containing
information on the site suitability issues
which the applicant wishes to have
resolved first. The second and third
parts, which constitute the remainder of
the application as described in
paragraph (a–1)(2)(ii) and (iii), must be
submitted during the period that the
partial decision on part one is effective,
viz., 5 years under new § 2.627 in
subpart F of part 2. There are no
considerations unique to combined
licenses which would weigh against
allowing a combined license applicant
to obtain early consideration of site
suitability issued under paragraph (a–1).
As with the change to paragraph (a)(5),
this revision to paragraph (a–1)
constitutes revisions to the
Commission’s rules of procedure and
practice. Accordingly, the Commission
may adopt them in final form without
further notice and comment, under the
rulemaking provisions of the APA, 5
U.S.C. 553(b)(A).
5. Section 2.102, Administrative Review
of Application
This section is revised by adding
conforming references in § 2.102(a) to
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applications for early site permits,
standard design approvals, combined
licenses, and manufacturing licenses
under part 52. Under the revised
section, the NRC staff will establish a
review schedule for an application for
these processes, thereby treating the
applications the same as applications
for construction permits or operating
licenses.
6. Section 2.104, Notice of Hearing
Section 2.104 sets forth the NRC’s
requirements regarding publication in
the Federal Register of notice of
hearings. The former rule, as well as the
proposed part 52 rule, specified the
nature of the issues that the presiding
officer must address in both
uncontested and contested proceedings.
The NRC has decided, based upon its
experience in noticing hearings in the
last decade (in which the Commission’s
notices for more significant proceedings
have varied from requirements in this
section), as well as its consideration of
the nature of mandatory hearings under
Section 189 of the AEA, that much of
this detailed prescription of the content
of the notice of hearing should be
removed from § 2.104.
Accordingly, the language of § 2.104
has been considerably truncated from
the former rule. Paragraph (a) is largely
the same as former paragraph (a).
However, paragraph (b) has been
modified to specify only the
requirements of the notice of hearing
which are common to all proceedings.
All provisions in the former § 2.104
specifying the issues to be addressed by
the presiding officer are removed in the
final rule. Inasmuch as this revision is
to the NRC’s rules of procedure and
practice, the NRC may adopt them in
final form without further notice and
comment, under the rulemaking
provisions of the APA, 5 U.S.C.
553(b)(A).
Paragraph (c), (paragraph (m) in the
proposed rule, former paragraph (e))
requires the NRC to transmit a notice of
hearing on an initial application of a
license for a production or utilization
facility to an appropriate state official
and the chief executive of the
municipality or county in which the
facility is to be located or an activity is
to be conducted. In addition to the
redesignation, paragraph (c) is revised to
clarify that the notice must be provided
for applications for early site permits,
combined licenses, but not
manufacturing licenses. Manufacturing
licenses are excluded from the
notification provisions because the NRC
is not licensing any particular location
or site where manufacturing may occur
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(see discussion of the manufacturing
license concept).
7. Section 2.105, Notice of Proposed
Action
Section 2.105 contains the NRC’s
procedures for notices of proposed
actions where a hearing is not required
by law and if the Commission has
determined that a hearing is in the
public interest. Inasmuch as
amendments to combined licenses and
manufacturing licenses do not require a
mandatory hearing under the AEA,
§ 2.105(a)(4) is revised to clarify that the
procedures in § 2.105 also apply to
applications for amendments of
combined licenses and manufacturing
licenses. Furthermore, because the AEA
does not require a mandatory hearing
for the initial issuance of manufacturing
licenses, paragraph (a)(13) is added in
the final rule to provide for publication
of a notice of proposed action in
connection with an application for a
manufacturing license under subpart F
of part 52.
Under § 52.103(a), which implements
Section 189.a(1)(B)(i) of the AEA, the
NRC is required to publish in the
Federal Register a notice of intended
operation and an opportunity to request
a hearing with respect to compliance of
the facility with inspections, tests, and
acceptance criteria in a part 52
combined license. Accordingly, the NRC
is revising § 2.105 by adding
§ 2.105(a)(12) which addresses the
information to be contained in the
Federal Register notice required by
§ 52.103(a).
Because the Commission’s
authorization for a combined license
holder to operate under § 52.103 does
not constitute ‘‘issuance’’ of a license or
amendment under § 2.106, § 2.105(b)(3)
is added indicating that the Commission
will publish a notice of intended
operation in the Federal Register that
identifies the proposed Agency action as
making the finding under § 52.103(g).
Paragraph (b)(3)(iii) of the proposed
rule, which would have required that
the Commission publish, as part of that
Federal Register notice, a finding that
ITAAC have been met, has not been
included in the final rule. This is
because Commission may not have
made, at the time of the Federal
Register notice, the finding that all
ITAAC have been met. After careful
review of the language of Section 189 of
the AEA, the Commission concludes
that the Federal Register notice required
by Section 189.a(1)(B)(i) need not
include a finding that ITAAC have been
met. Accordingly, § 2.105(b)(3) of the
final rule does not include a
requirement for such a finding to be
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expired until the renewal application
has been finally determined.
8. Section 2.106, Notice of Issuance
Section 2.106(a) formerly provided
that the NRC will publish in the Federal
Register a notice of issuance of a license
or amendment of a license where a
notice of proposed action has been
previously published, and notice of
amendment of a nuclear power plant
license. However, that language did not
require publication in the Federal
Register that the Commission has made
the finding under § 52.103(g). Although
the AEA does not require publication of
a notice of the Commission finding
under § 52.103, the Commission
believes that this publication is
desirable as a matter of public
transparency and consistency with past
practice of the Federal Register
publication of Commission action with
similar effects (i.e., the issuance of a
nuclear power plant operating license).
Accordingly, § 2.106(a) is revised to
require Federal Register publication of
the Commission finding under § 52.103.
Section 2.106(b)(2) is also revised to
set forth the minimum requirements for
the contents of a Federal Register notice
of action, e.g., the manner in which
copies of the safety analyses, if any, may
be obtained and examined, and a
finding that the prescribed inspections,
tests, and analyses have been performed
and that the acceptance criteria
prescribed in the combined license have
been met, and that the license complies
with the requirements of the AEA and
the NRC’s regulations. These provisions
are the same as the existing
requirements with respect to notices of
issuance for licenses and license
amendments, but adds the requirements
with respect to ITAAC mandated by
Section 185 of the AEA and part 52. The
NRC disagrees with the contention
raised by the nuclear industry that
Section 185 of the AEA limits the NRC
to a finding of compliance with respect
to ITAAC under § 52.103(g). Nothing in
the legislative history suggests that by
adopting Section 185 of the AEA,
Congress intended to override the NRC’s
long-standing practice of making
findings of compliance with the Act and
the Commission regulations when
issuing nuclear power plant licenses.
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included in the Federal Register notice
of intended operation.
10. Section 2.110, Filing and
Administrative Action on Submittals for
Standard Design Approval or Early
Review of Site Suitability Issues
In a conforming change, paragraphs
(a) and (b) of § 2.110 are revised to refer
to subpart E of part 52 and appendix Q
of part 50. Paragraph (c) is corrected by
adding § 2.110(c)(2) to address the
procedures applicable to administrative
determinations of submittals for early
review of site suitability issues;
formerly, paragraph (c) only refers to
standard designs.
9. Section 2.109, Effect of Timely
Renewal Application
Section 2.109 is revised to add
conforming references to a combined
license under subpart C of part 52. The
revised language clarifies that an
application for a combined license filed
no later than 5 years before its
expiration will not be deemed to have
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11. Section 2.111, Prohibition of Sex
Discrimination
This section prohibits sex
discrimination against certain persons
with respect to, inter alia, a license
under the AEA. This section is revised
to include standard design approvals
under part 52, and petitions for
rulemaking, including an application for
a design certification under part 52.
12. Section 2.202, Orders
This section is revised by
redesignating § 2.202(e) as § 2.202(e)(1),
and adding §§ 2.202(e)(2) through (5), to
indicate the backfitting provisions in
part 52 applicable to the various
licensing processes under part 52. No
provisions were deemed necessary to
address issuance of orders representing
backfitting of NRC approvals such as
standard design approvals.
13. Section 2.309, Hearing Requests,
Petitions To Intervene, Requirements for
Standing, and Contentions
Section 2.309, which establishes the
NRC requirements governing requests
for hearing and petitions to intervene—
including submission of contentions—is
revised to add three conforming and
clarifying changes. First, paragraph (a) is
revised, consistent with a change to
§ 52.103(c), to make clear that in a
proceeding under § 52.103, the
Commission itself will act as the
presiding officer, will consider and act
upon a request for a hearing under
§ 52.103, and will also determine
whether a period of interim operation
may be permitted, as provided for under
Section 189.a(1)(B)(iii) of the AEA.
Inasmuch as the Commission itself will
make the contention admission
determination, there should be no need
for further Commission review of the
contention admission decision at the
end of the hearing.
Second, paragraph (f)(1)(i) has been
revised to make clear that contentions in
§ 52.103(b) requests for hearing must
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49413
raise issues in law or fact with respect
to whether one or more of the
acceptance criteria in a combined
license have not been, or will not be
met, and that the specific operational
consequences of nonconformance
would be contrary to providing
reasonable assurance of adequate
protection to public health and safety.
This is consistent with the statutory
limitation on the scope of a hearing in
Section 189.a(1)(B)(ii) of the AEA.
Third, a new paragraph (f)(1)(vii) has
been added to set forth the specific
requirements for a contention under
Section 189.a(1)(B)(ii) and 10 CFR
52.103(b). The new paragraph provides
that, in a request for hearing under
§ 52.103(b), the information submitted
must be sufficient and include
supporting information showing, prima
facie, that: (i) One or more of the
acceptance criteria in a combined
license have not been, or will not be
met, and (ii) the specific operational
consequences of nonconformance
would be contrary to providing
reasonable assurance of adequate
protection to public health and safety.
The revision also makes clear that the
information in support of a contention
that an acceptance criterion is not, or
will not be met, must identify the
specific portions of the § 52.99(c) report
which is inaccurate, incorrect, or
incomplete. The terms, ‘‘inaccurate,’’
and ‘‘incorrect,’’ while somewhat
overlapping, are intended to cover a
broad range of situations. ‘‘Inaccurate’’
is intended to address a situation where
information contained in, referenced by,
or relied upon (either explicitly or
implicitly) as a supporting basis for a
representation in a § 52.99(c) report, is
erroneous (e.g., an erroneous
computation, or inaccurate data entry of
a test result). By contrast, ‘‘incorrect’’
focuses on a situation where such
information is the result of a cognitive
inadequacy or failure (even if, under the
circumstances, the inadequacy or failure
is justifiable), poor judgement,
negligence, or deliberate wrongdoing.
By ‘‘incomplete,’’ the NRC means that
the report does not provide the
information which must be provided in
the report as required by § 52.99.
Furthermore, if the requestor contends
that the § 52.99(c) report is incomplete,
and the requestor contends that the
incomplete portion prevents the
requestor from making the necessary
prima facie showing, then the requestor
must also, as provided by
§ 2.309(f)(1)(vii), explain why the
deficiency (viz., the incomplete nature
of the report) prevents the requestor
from making the necessary prima facie
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showing. The NRC believes that these
changes to § 2.309 will help ensure that
any 10 CFR 52.103 hearing on whether
the acceptance criteria in ITAAC have
been, or will be met, is focused only on
the matters which Congress intended to
be adjudicated at this juncture, as
directed by Section 189.a.(1)(B) of the
AEA.
Fourth, paragraph (g) is revised to
conform with the change in: (i) 10 CFR
52.103(c), which now provides that the
Commission will act as the presiding
officer in determining whether to grant
or deny a request for hearing with
respect to whether acceptance criteria in
ITAAC have been or will be met; and (ii)
10 CFR 2.310, which provides that the
Commission, acting as the presiding
officer, will determine the hearing
procedures to be utilized in a § 52.103
hearing. Under the revised paragraph
(g), a request for hearing under § 52.103
shall not address the hearing procedures
to be utilized.
Fifth, paragraph (h) is revised to
prohibit a reply by a requestor for a
hearing under § 52.103. The NRC
believes that Congress intended the
Commission’s initial decision to grant
the hearing and the determination of
interim operation to be based upon the
same set of information. The
Commission’s view is based upon the
language of Section 189.a.(1)(B)(iii),
which refers to a Commission
determination to allow a period of
interim operation based upon the
‘‘petitioner’s prima facie showing and
any answers thereto. * * *’’ That the
statute only refers to a request and the
answers thereto suggests that Congress
did not intend that a reply was
necessary. This is understandable given
Congress’’ explicit direction that any
hearing granted be completed ‘‘to the
maximum possible extent * * * within
180 days of the publication of the notice
[of opportunity to request a hearing
under Section 189.a(10)(B)(i)] or the
anticipated date for initial loading of
fuel into the reactor, whichever is later.’’
While the relevant statutory language
literally applies only to the Commission
determination of interim operation, the
NRC believes that as a matter of logic,
Congress must have intended that it
would also apply to the threshold
question of granting or denying the
hearing request. It is unclear why
Congress would allow more information
to be considered in the threshold
question of the hearing request, but
limit the information to be considered
in the interim operation determination.
The NRC concludes that it would be
closer to Congress’ intention to prohibit
a requestor for a § 52.103 hearing from
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replying to any answers filed by the
applicant and/or the NRC staff.
Finally, in a conforming change
associated with the revision to
§ 52.103(c), paragraph (i) is revised to
prohibit any ‘‘appeal’’ under § 2.311 of
a Commission decision to grant or deny
a request for hearing. Inasmuch as the
Commission is acting as a presiding
officer, there can be no further ‘‘appeal’’
to a higher agency decisionmaker.
Moreover, an adversely affected party
may seek reconsideration of the
Commission’s decision under § 2.345,
and it would be duplicative to afford an
adversely-affected party a § 2.311
‘‘review’’ right in addition to the
opportunity to seek reconsideration
under § 2.345.
Inasmuch as these revisions are to the
NRC’s rules of procedure and practice,
the NRC may adopt them in final form
without further notice and comment,
under the rulemaking provisions of the
APA, 5 U.S.C. 553(b)(A).
14. Section 2.310, Selection of Hearing
Procedures
Section 2.310 is revised, in part to
conform with the change in 10 CFR
52.103(c), which now provides that the
Commission will act as the presiding
officer in determining whether to grant
or deny a request for hearing with
respect to whether acceptance criteria in
ITAAC have been or will be met. The
revised § 2.310 now provides that the
Commission will determine the hearing
procedures to be utilized in its
determination on a hearing request
under § 52.103, as well as the hearing
procedures to be utilized in resolving
admitted contentions under § 52.103(c)
and (g).8
Inasmuch as this revision is to the
NRC’s rules of procedure and practice,
the NRC may adopt it in final form
without further notice and comment,
under the rulemaking provisions of the
APA, 5 U.S.C. 553(b)(A).
15. Section 2.340, Initial Decision in
Certain Contested Proceedings;
Immediate Effectiveness of Initial
Decisions; Issuance of Authorizations,
Permits, and Licenses
Section 2.340 addresses several
different matters relating to the
presiding officer’s initial decision and
its effect. The final rule reorganizes the
paragraphs in this section in order to
better distinguish among these matters,
reserves paragraphs (g) and (h) for future
use by the Commission, and makes
8 The
NRC notes that 10 CFR 2.309 does not
apply, by its terms, to petitions to modify the terms
and conditions of a combined license under 10 CFR
52.103(f). Such petitions must meet the
requirements of 10 CFR 2.206.
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substantial changes to these matters
addressed in this section, as discussed
below. These changes are to the NRC’s
rules of procedure and practice, and the
NRC is adopting the changes in final
form without further notice and
comment, under the rulemaking
provisions of the APA, 5 U.S.C. 5,
553(b)(A).
Scope of Presiding Officer’s Initial
Decision
Formerly, paragraph (a) limited the
scope of the presiding officer’s findings
and conclusions of law in initial
decisions in contested proceedings for
production or utilization facility
operating licenses to matters put into
controversy by the parties. Matters not
put into controversy by the parties
could only be examined by the
presiding officer by direction of the
Commission, either on its own initiative
or upon the presiding officer’s referral of
the matter to the Commission. In a
conforming change, a new paragraph (b)
is added to apply the limitation in
contested hearings under § 52.103(g)
with respect to whether the acceptance
criteria in a combined license ITAAC
have been, or will be met.
The § 2.340(a) limitation did not
apply to a contested utilization facility
construction permit proceeding.
Although the statement of
considerations for the original
rulemaking adopting this limitation (in
former § 2.760a) does not directly
address the basis for this limitation (see
January 17, 1975; 40 FR 2973), the
underlying rationale may be gleaned
from the Commission’s order in
Consolidated Edison Co. of New York
(Indian Point Nuclear Generating Unit
3), 8 AEC 7 (1974) which engendered
the rulemaking. In explaining that the
Licensing Board has no obligation at the
operating license stage to inquire into
matters which parties have not raised
and the Licensing Board itself has no
reason to inquire, the Commission
stated:
To have a Licensing Board engage in an
idle exercise examining issues just for the
sake of examination—when the parties have
not raised such matters, and the Board is
satisfied that there is nothing to inquire
about—would serve no useful purpose. This
is particularly true since an operating license
proceeding is not to be used to rehash issues
already well ventilated and resolved at the
construction permit stage. Alabama Power
Co. (Joseph M. Farley Nuclear Plant, Units 1
and 2), CLI–74–12 (RAI–74–3–203).
Id. at 8. Thus, the limitation was
based, in part, upon the broader scope
of inquiry for the presiding officer at
construction permit stage, which is a
‘‘mandatory hearing’’ required by
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Section 189.a(1)(A). This rationale
continues to apply today, and
consequently the NRC does not propose
to alter the NRC’s practice by extending
the § 2.340(a)/§ 2.760a limitation to
construction permit (including early site
permit) proceedings. Nor should the
§ 2.340(a)/§ 2.760a limitation apply in a
part 52 combined license proceeding
with respect to matters that would
otherwise be addressed and resolved in
a construction permit issuance
proceeding.
The final part 52 rule includes several
changes to implement the NRC’s
conclusions in this regard. Section
2.340(a) is revised to provide that the
presiding officer in a contested
operating license proceeding shall make
findings of fact and conclusions of law
to, inter alia, those matters put into
controversy or otherwise directed by the
Commission. Paragraphs (b), (c), and (d)
are revised to address the scope of the
presiding officer’s initial decision in a
combined license proceeding (including
a renewal or amendment proceeding), in
a proceeding under § 52.103(g), and in
a manufacturing license proceeding
(including a renewal or amendment
proceeding).
As discussed previously, the former
§ 2.340(a)/§ 2.760a limitation applied
only to operating license proceedings,
and did not apply to other contested
proceedings which do not require a
‘‘mandatory hearing,’’ which includes
most materials licensing proceedings
(with the notable exception of the
licensing of a uranium enrichment
facility). The statement of consideration
in this document merely states that the
rule codifies the Commission’s Indian
Point decision. (see January 17, 1975; 40
FR 2973 (first column)). Inasmuch as the
Indian Point proceeding involved a
utilization facility license, it is likely
that the Commission simply did not
consider as part of the rulemaking the
possibility of applying the limitation to
non-production or utilization facility
proceedings, as opposed to making a
deliberate decision not to apply the
limitation to non-production or
utilization facility proceedings.
Currently, the NRC believes that with 30
additional years of hearing experience,
there is no practical, compelling policybased, or legal reason why the § 2.340(a)
limitation should not be extended to
non-production or utilization facility
proceedings. Accordingly, the NRC is
revising § 2.340 by adding a new
paragraph (e), which extends the
existing limitation on the presiding
officer’s initial decision in contested
proceedings to all other proceedings not
covered by paragraphs (a) or (b) of
§ 2.340. Although this change is not
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related to the part 52 rulemaking effort,
the NRC is adopting this change as part
of the part 52 final rule to ensure that
stakeholders understand the provisions
of § 2.340 as an integrated whole.
Immediate Effectiveness of Presiding
Officer’s Initial Decision in Production
and Utilization Facility Proceedings
The remainder of former § 2.340 was
an amalgam of the Commission’s
original rule (10 CFR 2.764 9) a
presiding officer’s initial decision in
certain proceedings was immediately
effective upon issuance, combined with
newer provisions—first adopted in 1979
and modified in 1981—which
suspended the immediate effectiveness
rule. The ‘‘automatic stay’’ provisions
were adopted following the accident at
TMI–2, in order to provide for the
Commission’s direct involvement in the
issuance of nuclear power plant
licenses. The Commission first issued
an Interim Statement of Policy and
Procedure in October 1979, which first
noted that the TMI–2 accident was
being investigated by the NRC and may
result in ‘‘significant changes in the
Commission’s regulatory policy and in
the procedures it employs to license
nuclear power facilities.’’ The Policy
Statement then indicated that ‘‘new
construction permits, limited work
authorizations, or operating licenses for
any nuclear power plants shall be
issued only after action of the
Commission itself.’’ (See October 10,
1979; 44 FR 58559.) Soon thereafter, on
November 9, 1979 (44 FR 65049), the
NRC issued a Suspension of § 2.764 and
Statement of Policy on the Conduct of
Adjudicatory Proceedings. As part of
this final rulemaking, the NRC adopted
a new appendix B to part 2 addressing
the suspension of immediate
effectiveness provisions in § 2.764, and
providing for both Atomic Safety and
Licensing Appeal Board review and
Commission review of the presiding
officer’s initial decision.
On May 28, 1981 (46 FR 28627), the
NRC issued a final rule which removed
the need for the Appeal Board review of
a presiding officer’s initial decision, but
retained a minimum 60-day period for
Commission review. The final rule was
almost immediately amended to exclude
from Commission review presiding
officer decisions authorizing fuel load
and low-power testing (September 30,
1981; 46 FR 47764). In 2004, the
provisions in § 2.764 were transferred
without substantive change to a new
§ 2.340 as part of the general revision to
10 CFR part 2 (January 14, 2004; 69 FR
2182).
9 31
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49415
While the NRC’s 1979 and 1981
rulemakings were justified in light of
the circumstances at that time, other
factors now lead the NRC to believe that
the oversight provisions adopted in
1981 are no longer necessary or
desirable. In the 25 years since the
adoption of the 1981 provisions, the
NRC’s regulatory framework and
requirements for nuclear power plants
has evolved and strengthened. The
NRC’s technical requirements for
nuclear power reactors were
substantially augmented in the years
immediately following the TMI
accident, and thereafter have evolved to
reflect lessons learned, new
information, and the increasing
acceptance of risk-informed
methodologies. Similarly, the NRC’s
oversight of nuclear power plants has
evolved to reflect lessons learned, new
information, and the maturation of risk
assessment methodologies. Thus, the
NRC believes its regulations may be
revised to remove the regulatory
requirement for direct Commission
involvement in all production and
utilization licensing proceedings. The
Commission’s words in the May 1981
final rulemaking apply with more force
today:
This amendment does not compromise the
Commission’s commitment to the protection
of public health and safety or to a fair hearing
process. Thorough technical safety reviews of
license applications by the NRC staff and the
Advisory Committee on Reactor Safeguards,
the availability of public hearings on license
applications, and the Commission’s inherent
supervisory authority form the basis of the
network of procedural safeguards intended to
implement this commitment to a fair
decision process and public health and
safety. (May 28, 1981; 46 FR 28628 first
column)
The NRC’s commitment remains
unchanged, and the NRC’s safeguards
have been strengthened since that time,
for example, by refocusing the
regulatory process to include
considerations of risk. In addition, the
NRC’s rules of practice in part 2 provide
several procedural safeguards within the
NRC’s administrative process,
including: (1) A petition for presiding
officer reconsideration under § 2.345; (2)
a petition for Commission review under
§ 2.341; and (3) a motion for a stay with
the presiding officer or the Commission
under § 2.342.
By removing the ‘‘automatic stay’’
provisions in former § 2.340(f) and (g),
the NRC’s administrative process will be
completed in less time, thereby
benefitting all parties from the reduction
in litigation resources without
compromising the fairness of the overall
hearing process. Faster completion of
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the adjudication will also enable
aggrieved parties to more quickly seek
relief via an appeal to a U.S. Circuit
Court of Appeals. The NRC believes that
Congress intends the Commission to
conduct fair, but efficient, hearings with
respect to licensing, and to remove
unnecessary hearing procedures which
do not contribute to such a hearing
process. This is evidenced by Section
189 of the AEA, as amended by the
Energy Policy Act of 1992, which
directs the Commission to issue, ‘‘to the
maximum possible extent,’’ a final
decision on issues raised with respect to
acceptance criteria by the anticipated
date for initial loading of fuel. The
Commission concludes that the changes
to § 2.340 are consistent with applicable
law, and will provide tangible benefits
to all parties in NRC adjudications.
greater time to respond to potentially
adverse situations. Compare 46 FR
47764, 47765 (issuance of licenses for
activities involving minimal risk to
public health and safety, and greater
time to take corrective action, do not
require Commission involvement).
Furthermore, the Commission possesses
general supervisory authority over the
NRC staff and may direct the staff to
keep the Commission appraised of
licensing status and issues for such
licenses. Accordingly, the NRC
concludes that there is little regulatory
benefit to be provided by a rule
requiring direct Commission
involvement in the issuance of these
licenses and that the provisions in
§ 2.340 providing for such involvement
should also be removed as part of this
streamlining of the regulatory process.
Immediate Effectiveness of Presiding
Officer’s Initial Decision in Other, NonProduction or Utilization Facility
Proceedings
As noted previously, the 1981 final
rulemaking provided for an ‘‘automatic
stay’’ to provide for direct Commission
involvement in the issuance of nuclear
power plant licenses. Since that time,
the NRC has extended the ‘‘automatic
stay’’ provisions in § 2.340 to other
licensing contexts, such as independent
spent fuel storage facilities (ISFSIs) at
sites away from nuclear power reactors,
monitored retrievable storage (MRO)
licenses, and provided for a parallel
provision in 10 CFR part 61 for lowlevel waste (LLW) facilities, see 10 CFR
2.1211. The NRC did not explain the
basis for requiring direct Commission
involvement in the issuance of a part 61
LLW license (see 47 FR 57446;
December 27, 1982), although one could
surmise from the timing of the
rulemaking that the factors underlying
the 1981 rulemakings also were the
basis for the 1982 rulemaking’s
provision providing for direct
Commission involvement in part 61
license issuances. The NRC’s original
intent in requiring direct Commission
involvement in the issuance of specific
ISFSI licenses and a MRS license was
the lack of regulatory experience (see,
e.g., 60 FR 20879 and 20883; April 28,
1995), and, therefore, is somewhat
different from the motivating factors for
the 1981 rulemakings. In any event, the
NRC now has had the benefit of
experience in licensing a specific ISFSI,
as well as several specific ISFSIs located
at reactor sites. Thus, the NRC has come
to a recognition that the safety, security
and regulatory issues associated with
these licenses are of less complexity
than those associated with nuclear
power plants, and that the NRC has
Issuances of Authorizations, Permits,
Licenses, and § 52.103(g) Findings
Former paragraph (c) of § 2.340
provided that the appropriate staff
Office Director was authorized to issue
certain delineated licenses, including
license amendments, construction
permits, and construction
authorizations, within 10 days from the
date of issuance of an initial decision.
The former language could be
erroneously read as requiring the
Director to issue a license following an
initial decision on a contested matter,
even if other issues not contested had
yet to be resolved by the NRC staff. In
addition, paragraph (c) did not address
the issuance of a finding under
§ 52.103(g). To resolve these concerns,
new paragraphs (i), (j), and (k) are added
to § 2.340. In general, each paragraph
authorizes the appropriate staff Office
Director to issue the delineated license,
permit, authorization or finding within
10 days from the issuance of an initial
decision, if all other safety and
environmental findings necessary for
issuance of the license, permit,
authorization or finding have been
made, notwithstanding the pendency of
various petitions or motions for
reconsideration, review or stay before
the presiding officer or the Commission.
Paragraph (i) authorizes the Director
of Nuclear Reactor Regulation (NRR) or
the Director of the Office of New
Reactors (NRO), as appropriate, to issue
nuclear power plant licenses, including
amendments, permits and
authorizations, within 10 days of the
initial decision. Paragraph (j) authorizes
the Commission or the appropriate staff
Office Director to make the finding
under 10 CFR 52.103(g) that the
acceptance criteria in a combined
license have been met. Finally,
paragraph (k) addresses the issuance of
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other licenses that are issued by the
Director of Nuclear Material Safety and
Safeguards (NMSS). Typical licenses of
this type would be materials licenses
for, inter alia, medical uses, well
logging, radiography, irradiators, and
research.
16. Section 2.341, Review of Decisions
and Actions of a Presiding Officer
This section addresses requests for
review and appeals to the Commission
from a presiding officer’s decision or
actions in a hearing. In a conforming
change associated with the revision to
§ 52.103(c), paragraph (a)(1) of § 2.341 is
revised to explicitly prohibit a party
from seeking a ‘‘review’’ or an ‘‘appeal’’
of the Commission’s determination to
allow a period of interim operation
under § 52.103(c), separate from and in
addition to a request for reconsideration
under § 2.345. Inasmuch as the
Commission is acting as the presiding
officer in the § 52.103(c) determination,
there can be no further ‘‘appeal’’ to a
higher agency decisionmaker. Moreover,
it would be duplicative to afford a
§ 2.341 ‘‘review’’ or ‘‘appeal’’ right in
addition to the opportunity to seek
reconsideration under § 2.345.
Inasmuch as this revision is to the
NRC’s rules of procedure and practice,
the NRC may adopt it in final form
without further notice and comment,
under the rulemaking provisions of the
APA, 5 U.S.C. 553(b)(A).
17. Section 2.347, Ex Parte
Communications
Section 2.347, which sets forth the
NRC’s requirements governing ex parte
communications with the Commission
and its adjudicatory employees, is
revised in this final rule to address
several problems with the current rule.
First, § 2.347 is revised to make clear
that ex parte communication
restrictions are not applicable in
uncontested proceedings. The APA
requirements in 5 U.S.C. 557(d)(1)
governing ex parte communications
apply only to communications ‘‘relevant
to the merits of the proceeding * * *,’’
which are made to and from ‘‘interested
persons outside the agency.’’ In an
uncontested proceeding, there are no
‘‘interested persons outside the agency,’’
in the sense that there are no persons for
which a hearing has been requested or
intervention in a hearing has been
granted. Hence, ex parte communication
restrictions do not apply. Moreover, as
the NRC has stated in the 2004
rulemaking revising 10 CFR part 2,
Section 189 of the AEA does not require
NRC hearings under that section to be
‘‘on the record.’’ See 69 FR 2183–2185,
2192–2193 (January 14, 2004).
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Accordingly, § 2.347 is revised to
explicitly provide that ex parte
restrictions do not apply to uncontested
proceedings.
Second, § 2.347 is revised to exclude
undisputed (i.e., uncontested) issues in
contested proceedings from the
application of ex parte restrictions. It
makes little sense to require the
Commission to inform parties to the
proceeding of the Commission’s
communications with the applicant or
licensee on matters for which those
parties have not been admitted (and
may have no interest in litigating). In
addition, the NRC believes that
uncontested matters are not, for
purposes of applying the ex parte
limitations in Section 557(d)(1) of the
APA, either ‘‘a fact in issue’’ or a matter
which is ‘‘relevant to the merits of the
[contested] proceeding.’’ The NRC also
believes, as stated above, that the ex
parte limitations in Section 557(d) of
the APA do not apply to NRC
proceedings, and therefore the
application of ex parte restrictions in
NRC proceedings is a matter of
discretion on the part of the NRC. The
NRC believes that it is appropriate to
exclude undisputed issues from the
application of ex parte limitations in
contested proceedings, inasmuch as
there appears to be little, if any, public
confidence benefit from extending ex
parte limitations to ‘‘undisputed
issues,’’ i.e., matters which have not
been raised by any party in the
proceeding.
Finally, § 2.347 is also revised to
make clear that ex parte restrictions
apply to matters which are the subject
of a presiding officer referral to the
Commission under § 2.340(a), and the
presiding officer’s examination of that
matter following Commission approval
under § 2.340(a) (referred to as ‘‘sua
sponte’’ issues at 53 FR 10361; March
31, 1988). The application of ex parte
restrictions to § 2.340(a) ‘‘sua sponte’’
matters does not represent a change in
NRC practice, cf., 53 FR 10360, 10361
(first and second column) (March 31,
1988). Nonetheless, upon further
reflection the NRC believes it is
inaccurate to treat § 2.340(a) ‘‘sua
sponte’’ matters as a ‘‘disputed issue’’
for purposes of applying § 2.347.
Accordingly, the NRC is revising § 2.347
to explicitly state that consideration of
§ 2.340(a) ‘‘sua sponte’’ matters are to be
subject to ex parte restrictions.
Inasmuch as these § 2.347 revisions
are to the NRC’s rules of procedure and
practice, the NRC may adopt them in
final form without further notice and
comment under the rulemaking
provisions of the APA, 5 U.S.C.
553(b)(A).
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18. Section 2.348, Separation of
Functions
This section sets forth the NRC’s
requirements governing separation of
functions of the Commission and its
adjudicatory employees when acting in
their adjudicatory capacity. The rule
prohibits an NRC officer or employee
engaged in the performance of
investigative or litigation function in
that proceeding from participating in or
advising the Commission and its
adjudicatory employees about ‘‘any
disputed issue in that proceeding
* * *,’’ with certain delineated
exceptions (10 CFR 2.348(a)).
The NRC believes that there are two
problems with the current language.
First, the rule does not explicitly state
that in an uncontested proceeding,
separation of functions does not apply.
More importantly, the rule applies
separation of functions in circumstances
where it is not required by Section
554(d), viz., determinations involving
initial licenses (5 U.S.C. 554(d)(2)(A) of
the APA). The NRC recognizes that
public confidence considerations may
favor compliance with separation of
functions restrictions in contested
initial licensing proceedings. However,
there is little apparent value in applying
separation of functions to the NRC’s
resolution of uncontested (i.e.,
‘‘undisputed’’) issues in contested
proceedings. The NRC also notes that
(as in the case of the APA restrictions
on ex parte communications) the APA
separation of functions requirements
apply only to adjudications which are
required to be ‘‘on the record.’’ As
discussed above, NRC licensing
proceedings are not required by the
AEA or any other statute to be on the
record. Thus, there is no legal
requirement to apply separation of
functions in initial licensing
proceedings. Although the NRC could
voluntarily, as a matter of discretion,
apply separation of functions in
circumstances where it is not required
by law, such a course of action seems
unjustified in view of the lack of a clear
public confidence benefit—which is the
primary objective of separation of
functions restrictions. For these reasons,
the final part 52 rule revises § 2.348 to
make explicit that separation of
functions requirements do not apply to
either uncontested proceedings, or to an
undisputed issue in contested initial
licensing proceedings.
Section 2.348 is also revised to make
clear that separation of functions
applies to matters which are the subject
of a presiding officer referral to the
Commission under § 2.340(a), and the
presiding officer’s examination of that
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49417
matter following Commission approval
under § 2.340(a). As with the change in
§ 2.347 with respect to ex parte
restrictions, this change in § 2.348 does
not depart from the NRC’s current
practice of applying separation of
function restrictions to ‘‘sua sponte’’
matters under § 2.340(a). The NRC
believes that it is more accurate to
explicitly state that sua sponte matters
under § 2.340(a) are subject to
separation of functions restrictions,
rather than characterizing such matters
as ‘‘disputed issues.’’
Inasmuch as these § 2.348 revisions
are to the NRC’s rules of procedure and
practice, the NRC may adopt them in
final form without further notice and
comment under the rulemaking
provisions of the APA, 5 U.S.C.
553(b)(A).
19. Section 2.390, Public Inspections,
Exemptions, Requests for Withholding
Section 2.390 governs the availability
of NRC records and documents
regarding a license, permit or order, and
implements the Freedom of Information
Act (FOIA). This section is revised to
make clear that its provisions also
applies to NRC records and documents
regarding standard design approvals
under part 52.
20. Subpart D—Additional Procedures
Applicable to Proceedings for the
Issuance of Licenses To Construct and/
or Operate for Nuclear Power Plants of
Identical Design at Multiple Sites
Formerly, subpart D of part 2 set forth
the Commission’s administrative and
hearing procedures for proceedings for
issuance of construction permits and
operating licenses under part 52 for
nuclear power plants of ‘‘duplicate’’
design at multiple sites. The
requirements governing the content of
such applications and the technical
consideration of such applications are
set forth in 10 CFR part 50, appendix N,
which was ‘‘transferred’’ to part 52 as
part of the 1989 part 52 rulemaking.
However, the 1989 rulemaking did not
remove appendix N from part 50, nor
did the NRC make conforming changes
to appendix N in part 52 to make its
provisions applicable to combined
licenses under subpart C of part 52. As
discussed elsewhere, in the March 2006
proposed rule the NRC proposed
deleting appendix N in part 52, and
retaining these provisions in part 50.
Although no comment was received on
this proposal, the NRC has decided to
withdraw its proposal to delete
appendix N in part 52. Instead, the NRC
is revising appendix N in part 52 to
apply only to proceedings for combined
licenses under subpart C of part 52
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(appendix N in part 50 will continue to
address proceedings for construction
permits and operating licenses under
that part).
To reflect the expanded scope of
appendix N of part 52 and to ensure that
all of the NRC’s regulations use
consistent terminology, the NRC is
revising subpart D of part 2 as part of
this final rulemaking. Inasmuch as the
changes to the provisions in subpart D
constitute revisions to the NRC’s rules
of procedure and practice, the NRC may
adopt them in final form without further
notice and comment, under the
rulemaking provisions of the APA, 5
U.S.C. 553(b)(A).
21. Section 2.400, Scope of Subpart
This section is revised to refer to both
appendix N of both part 50 and part 52,
in order to reflect the Commission’s
determination that the appendix should
be retained in both parts, and that the
procedures in the appendices (both of
which refer to this subpart) should
apply to applications for construction
permits, operating reactors, and
combined licenses of identical design.
In addition, § 2.400 is revised to use the
term ‘‘identical design,’’ instead of the
former ‘‘essentially the same design,’’ so
that subpart D and appendix N of part
50 and part 52 use identical
terminology.
22. Section 2.401, Notice of Hearing on
Construction Permit or Combined
License Applications Pursuant to
Appendix N of 10 CFR Parts 50 or 52
Paragraph (a) of § 2.401 is revised to
indicate that notices of hearing will be
published for both construction permits
under part 50 and combined licenses
under part 52. Notices of the issuance of
operating licenses is addressed, as was
the case under the former provisions of
subpart D, in § 2.403. No other
substantive changes are intended by this
revision. Paragraph (b) remains
unchanged.
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23. Section 2.402, Separate Hearings on
Separate Issues; Consolidation of
Proceedings
Both paragraphs of this section are
revised to refer to applications under
part 50 and part 52. No other
substantive changes are intended by this
revision.
24. Section 2.403, Notice of Proposed
Action on Applications for Operating
Licenses Pursuant to Appendix N of 10
CFR Part 50
This section is revised to refer to
operating licenses issued under part 50,
rather than part 52. This reflects the
Commission’s determination that
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appendix N of part 50 applies to
construction permits and operating
licenses, whereas appendix N of part 52
applies to combined licenses under
subpart C of part 52.
processes (with the exception of
standard design certifications, which are
addressed in subpart H of part 2).
25. Section 2.404, Hearings on
Applications for Operating Licenses
Pursuant to Appendix N of 10 CFR Part
50
The text of these sections is removed,
and their places are reserved in the final
rule, because the matters addressed in
these sections, regarding finality and the
referencing of a manufactured reactor in
a combined license, are addressed with
greater specificity in the revisions to
subpart F of part 52.
This section is revised to make
clarifying changes by adding references
to a presiding officer, correctly referring
to the Chief Administrative Judge, and
removing a reference to the atomic
safety and licensing board. No
substantive changes are intended by this
revision.
26. Section 2.405, Initial Decisions in
Consolidated Hearings
This section is revised by requiring
the presiding officer to issue a separate
partial initial decision on the common
design. Section 2.405 is also revised by
clarifying that the presiding officer may,
if otherwise determined under the
consolidation provisions of § 2.317(b),
issue a consolidated decision for those
proceedings. No other substantive
changes are intended by this revision.
27. Section 2.406, Finality of Decisions
on Separate Issues
This section is revised to refer to both
appendix N of both part 50 and part 52.
No other substantive changes are
intended by this revision.
28. Section 2.407, Applicability of Other
Sections
This section is revised to correctly
reference subparts C, L, and N of part 2.
No other substantive changes are
intended by this revision.
29. Section 2.500, Scope of Subpart
This section is revised by adding a
conforming reference to subpart F of
part 52 on manufacturing licenses.
30. Section 2.501, Notice of Hearing on
Application Under Subpart F of Part 52
for a License To Manufacture Nuclear
Power Reactors
This section is revised by adding a
conforming reference to subpart F of
part 52 on manufacturing licenses. In
addition, paragraph (b) of this section is
revised by removing the detailed
requirements governing the content of
the notice of hearing published in the
Federal Register, and instead
referencing proposed § 2.104(f). As
previously discussed, the Commission
is consolidating in § 2.104 the
requirements governing the content of a
notice of hearing with respect to part 52
licensing and regulatory approval
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31. Sections 2.502, 2.503, and 2.504
32. Subpart F, Additional Procedures
Applicable to Early Partial Decisions on
Site Suitability Issues in Connection
with an Application for a Construction
Permit or Combined License for Certain
Utilization Facilities
Subpart F provides special procedures
for the acceptance, docketing,
administrative consideration, the
conduct of hearings, and the presiding
officer’s issuance of a partial initial
decision in licensing proceedings where
there is early submittal of site suitability
information in connection with an
application for a construction permit or
operating license, as described in
§ 2.101(a–1). As discussed earlier, the
NRC has revised § 2.101(a–1) to allow
applicants for combined licenses under
part 52, as well as applicants for
construction permits under part 50, to
submit their applications in two parts,
and to allow for early consideration and
presiding officer’s partial initial
decision on those site suitability matters
for which the applicant seeks early
resolution in accordance with subpart F
of part 2.
The NRC has reorganized subpart F in
an attempt to improve its usability (the
reorganization is reflected in the
provisions of § 2.600, Scope of subpart).
Requirements applicable to partial
decisions in construction permit
proceedings continue to be addressed in
§§ 2.602 through 2.606; a new
subheading is added before § 2.602 to
reflect the subject matter of these
sections. The new requirements
applicable to partial decisions in
combined license proceedings are in
§§ 2.621 through 2.629; a new
subheading is also added before § 2.621
to reflect the subject matter covered by
these sections. Section 2.629, which has
no analogous provisions in §§ 2.602
through 2.606, is added by the NRC to
ensure that the finality of a presiding
officer’s partial initial decision in a
combined license proceeding is clearly
addressed using regulatory language
similar to that used in the finality
provisions in part 52, e.g., §§ 52.39,
52.63, 52.98.
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Section 2.601 is revised to correctly
list subparts A, C, G, L, and N of part
2 as subparts which are either
applicable to or may be utilized in
proceedings under subpart F.
33. Section 2.800, Scope and
Applicability
Subpart B of part 52 sets out the
requirements applicable to Commission
issuance of regulations granting
standard design certification for nuclear
power facilities. Standard design
certifications are approved through a
rulemaking proceeding, and, in concept,
the applicant for a design certification
may be considered as a petitioner for
rulemaking. However, subpart H of part
2, which sets forth the Commission’s
procedures governing rulemaking,
including petitions for rulemaking, did
not specifically address design
certification. Furthermore, based upon
the Commission’s experience with three
final design certification rules and a
proposed design certification rule, it is
clear that some of the procedural
requirements applicable to petitions for
rulemaking are not well-suited to the
administrative process for determining a
design certification application, e.g., the
existing prohibition against preapplication consultation with the NRC.
These consultations between potential
license applicants and the NRC staff are
not currently prohibited and indeed are
encouraged by the Commission to
enhance NRC resource planning and to
facilitate early identification and
resolution of technical and regulatory
issues. An application for design
certification is more like a license
application than a traditional petition
for rulemaking, and the current
prohibition against pre-application
consulting appears to be inconsistent
with the Commission’s strategic
objectives of safety, effectiveness, and
management excellence. The
Commission also believes, based upon
its experience, that administrative
provisions ordinarily applied in the
context of licensing (e.g., docketing and
acceptance review, denial of application
for failure to supply information),
should also be available for application
as appropriate in its determination of
design certification applications.
For these reasons, the Commission is
revising subpart H of part 2 to address
standard design certifications. Section
2.800 is revised to delineate which
provisions of subpart H are applicable to
all petitions for rulemaking, and which
provisions are applicable only to initial
applications for design certification and
applications for amendments to existing
design certification rules filed by the
original applicant (or successors in
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interest). The title of § 2.800 is revised
to reflect the additional function of this
section. New §§ 2.811 through 2.819 are
added to address initial applications for
design certification as well as
applications for amendments to existing
design certifications filed by the original
applicant (or successors in interest), and
are based upon §§ 2.101, 2.107, and
2.109. Petitions for amendment of
existing design certification, which are
filed by third parties other than the
original applicant for that design
certification (or successor in interest),
will be treated as an amending petition
for rulemaking under the provisions of
§§ 2.801 through 2.810.
34. Section 2.801, Initiation of
Rulemaking
In a conforming change, § 2.801 is
revised to refer to applications for
standard design certification
rulemaking.
35. Section 2.811, Filing of Standard
Design Certification Application;
Required Copies
New § 2.811 clarifies the requirements
that are related to the filing of
applications for standard design
certifications. The requirements in this
section are derived from procedural
requirements for license applications
located in several different regulations
in part 50. Section 2.811(a), which is
analogous to § 50.4(a), identifies the
NRC addresses where an application for
a standard design certification must be
filed, and provides the requirements for
electronic submission of a design
certification application. Section
2.811(b), which is analogous to
§ 50.30(a)(1) and (3), provides that a
standard design certification application
must meet the written communications
requirements in § 2.813. Section
2.811(c), which is analogous to
§ 50.30(a)(2), requires the applicant to
have the capability to make and supply
additional copies of the application
upon NRC request. Section 2.811(d),
which is analogous to the requirement
in § 50.30(a)(4), requires the applicant to
make a copy of the updated application
for use by any party in a hearing
conducted under subpart O of part 2 (a
legislative-style hearing). Section
2.811(e), which addresses preapplication consultation with the NRC
staff, provides that the potential
applicant for a design certification may
consult with the NRC on the subject
matters listed in § 2.802(a)(1)(i) through
(iii), including the procedure and
process for filing and processing an
application for a design certification.
However, § 2.811(e) also allows the
prospective standard design
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49419
certification applicant to consult with
the NRC staff on substantive technical
and regulatory matters relevant to the
design certification; the prohibitions in
§ 2.802(a)(2) do not apply to these
consultations.
36. Section 2.813, Written
Communications
New § 2.813 contains procedural and
‘‘housekeeping’’ requirements governing
written communications with the NRC,
and are derived from analogous
requirements located in several different
regulations in part 50. Section 2.813(a)
is analogous to § 50.4(a). Section
2.813(b) is analogous to § 50.4(c), and
sets forth the requirement that written
copies be submitted in permanent form
on unglazed paper. Section 2.813(c) is
analogous to § 50.4(d), and expresses the
Commission’s preference that the upper
right corner of the first page of the
applicant’s submission set forth the
specific regulation or other basis which
instigated the written communication.
37. Section 2.815, Docketing and
Acceptance Review
New § 2.815 is analogous to
§ 2.101(a)(2), and permits the NRC to
conduct a review to determine whether
the application is complete (i.e.,
addresses all matters specifically
required by NRC regulation to be
addressed in an application) and
acceptable for docketing. Section
2.815(a) provides that the NRC may
determine, in its discretion, the
acceptability for docketing of an
application based on the technical
adequacy of the application, not just on
the completeness of the application.
38. Section 2.817, Withdrawal of
Application
New § 2.817 is analogous to § 2.107,
and addresses the procedures that the
NRC will follow if a design certification
applicant withdraws its application.
Section 2.817 also provides for a notice
of action on the withdrawal on the NRC
Web site if the notice of application was
published on the NRC Web site.
39. Section 2.819, Denial of Application
for Failure To Supply Information
New § 2.819 is analogous to § 2.108,
and states in paragraph (a) that the NRC
may deny an application for a standard
design certification if the applicant fails
to respond to an NRC request for
additional information concerning its
application within 30 days of the
request. Section 2.819(b) provides that
the NRC will publish in the Federal
Register a document denying the
application. Section 2.819(b) also states
that the NRC will publish a notice on
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the NRC’s Web site denying the
application if the NRC previously
published a notice of receipt of the
application on the NRC Web site.
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40. Section 2.1202, Authority and Role
of NRC Staff
Paragraph (a) of § 2.1202
acknowledges and confirms the
authority of the NRC staff to take
regulatory (including licensing) action
during the pendency of a hearing, with
several delineated exceptions in
numbered paragraphs (a)(1) through (5).
Most of these exceptions are mandated
by Section 189.a.(1)(A) of the AEA,
which requires that the NRC hold a
‘‘mandatory hearing,’’ after 30 days
notice and publication once in the
Federal Register, on any application for
a construction permit for a facility to be
licensed under Section 103 or 104b.
Paragraph (a)(1) is revised by adding
specific references to applications for
limited work authorizations and
combined licenses under 10 CFR part
52. A limited work authorization is
considered to be a partial construction
permit, and a combined license under
part 52 includes a construction permit.
Therefore, they are both subject to the
strictures of Section 189.a.(1)(A).
Paragraphs (2), (3), and (4) are
redesignated as paragraphs (4), (5), and
(6), and a new paragraph (2) is added for
early site permits applications. An early
site permit is considered to be a partial
construction permit, and therefore is
also subject to Section 189.a(1)(A). A
new paragraph (3) is added for
manufacturing licenses, as a matter of
NRC discretion. The Section
189.a.(1)(A) requirement for a
mandatory hearing applies only to
construction permits; a manufacturing
license is not a construction permit.
Hence, the remaining provisions of
Section 189.a.(1)(A), including the
NRC’s authority to issue an operating
license or amendment to a construction
permit without a hearing but only upon
30 days notice and publication once in
the Federal Register of the NRC’s intent
to do so, are inapposite and do not
constrain the NRC’s authority to issue
manufacturing licenses despite a
pending hearing. Nonetheless, as a
matter of discretion, the NRC has
decided to treat manufacturing licenses
similar to construction permits in this
regard, although the NRC reserves the
right to change its practice in the future.
G. Changes to 10 CFR Part 10
1. Section 10.1, Purpose; and § 10.2,
Scope
Part 10, which contains the NRC’s
requirements and procedures for
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determining eligibility for granting
access to Restricted Data and National
Security Information, did not reflect the
licensing and approval processes in part
52. Accordingly, the Commission made
two changes to ensure that there are
defined criteria and procedures
governing requests for access to
Restricted Data and National Security
Information by individuals with respect
to a license or approval under part 52.
Section 10.1 is revised by adding a
new paragraph (a)(3), which refers to the
eligibility of individuals for
employment with NRC licensees and
applicants, and holders of standard
design approvals under part 52. Section
10.2(b) is revised so that it refers to
standard design approvals under part 52
and applicants for consultants. This
change will address the provision of
services associated with design
approvals, who may not, per se, be
‘‘employees.’’
H. Changes to 10 CFR Part 19
Part 19, entitled Notices, Instructions
and Reports to Workers: Inspection and
Investigations, establishes the NRC’s
requirements for notices, instructions
and reports to persons participating in
NRC licensed and other regulated
activities. For example, it requires
licensees and applicants for licenses to
post a copy of, inter alia, the regulations
in 10 CFR parts 19 and 20, and NRC
Form 3. NRC Form 3 provides a
statement of rights and responsibilities
to employees with respect to NRC
requirements. Part 19 also establishes
the rights and responsibilities of the
NRC and individuals during interviews
compelled by subpoena as part of a NRC
inspection or investigation under
Section 161.c of the AEA. Finally, part
19 prohibits, on the grounds of sex, the
exclusion from participation in, or being
subjected to discrimination under any
program or activity licensed by the NRC.
The regulatory authority for part 19
stems from Sections 211 and 401 of the
Energy Reorganization Act of 1974, as
amended (1974 ERA).
The NRC has identified a number of
weaknesses with the former regulatory
language in part 19. Formerly, part 19’s
regulatory requirements and
proscriptions applied only to licensees
who receive, possess, use or transfer
material licensed under the NRC’s
regulations, including persons licensed
to operate a production or utilization
facility under 10 CFR part 50, but did
not cover holders of 10 CFR part 52
licenses such as combined licenses,
early site permits, and manufacturing
licenses. Moreover, part 19 applied only
to licensees who receive, possess, use or
transfer materials licensed under 10
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CFR parts 30 through 36, 39, 40, 60, 61,
63, 70 or 72 (including persons licensed
to operate a production or utilization
facility under part 50). Thus, the former
regulations did not appear to address
discrimination against an employee
during ‘‘non-operational’’ activities such
as manufacturing or construction of a
nuclear power plant. Because the NRC’s
regulatory scheme relies upon the
proper design, manufacture, siting, and/
or construction of a production or
utilization facility; discrimination
against an employee at any of these
stages could have significant adverse
public health and safety or common
defense and security implications and
effects. One would therefore expect that
part 19 would apply to such nonoperational activities. Finally, part 19
applied only to a ‘‘licensee’’ and
activities authorized by a ‘‘license’’ (see,
e.g., §§ 19.1, 19.2, 19.11, 19.20, 19.32),
and did not extend to part 52’s nonlicensing regulatory approvals, i.e.,
standard design approvals and standard
design certifications. Inasmuch as these
non-licensing activities regulated under
part 52 are not different in kind from the
licensing which are currently subject to
part 19 requirements, the NRC
concludes that they should also be
subject to the requirements in part 19.
Accordingly, the NRC is amending
various provisions in part 19 to ensure
that its provisions extend to applicants
for and holders of part 50 construction
permits, and combined licenses, early
site permits and manufacturing licenses
under part 52. In addition, the NRC
extends part 19 to cover applicants for
and holders of standard design
approvals and standard design
certifications. The NRC believes that its
regulatory authority under Section 211
and Section 401 of the 1974 ERA is
much broader than the former scope of
part 19. The anti-discrimination
proscriptions in Section 211 of the ERA
apply to any ‘‘employer,’’ which the
NRC regards as including non-licensee
entities otherwise regulated by the NRC,
such as applicants for and holders of
standard design approvals, and
applicants for standard design
certifications. The Commission believes
that the use of the term, ‘‘includes,’’ in
paragraph (a)(2) of Section 211 of the
1974 ERA was not intended to be an
exclusive list of the persons and entities
subject to the anti-discrimination
provisions in that section. The House
Report on H.R. 776, which was adopted
by Congress as the Energy Policy Act of
1992, states:
[Title V] also broadens the coverage of
existing whistle blower protection provisions
to include * * * any other employer engaged
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in any activity under the Energy
Reorganization Act of the Atomic Energy Act
of 1954. (H. Rep. No. 102–474, part 8, 102d
Congress, 2d Sess., at 78–79 (1992) (emphasis
added))
There was no discussion of the
statutory language in the conference
report. (H.R. Conf. Rep. No. 102–1018,
102d Cong., 2d Sess. (1992)). The
provisions in Section 401 of the ERA,
prohibiting sex discrimination apply to
‘‘any program or activity carried on
* * * under any title of this Act.’’
Accordingly, the NRC concludes that it
has the authority to extend the former
scope of part 19 to address the nonlicensing regulatory approvals in part
52.
To implement the NRC’s broadening
of the scope of part 19, §§ 19.1 and 19.2
are revised to explicitly refer to: (1)
applicants for and holders of licenses
and permits under part 52; (2)
applicants for and holders of final
design approvals; and (3) applicants for
standard design certifications. The NRC
notes that the existing provision in
§ 19.2 excluding part 19 from applying
to NRC employees and NRC contractors
remains unchanged in the final rule. To
provide a convenient term for referring
to persons and entities applying for, or
granting non-licensed regulatory
approvals in part 52, as well as any
future regulatory processes, the NRC is
amending § 19.3 to the terms, regulated
activities, and regulated entities.
Regulated entities are defined to include
(but not be limited to) applicants for and
holders of standard design approvals
under subpart E of part 52, and
applicants for standard design
certifications under subpart B of part 52.
Section 19.11 establishes
requirements for posting of notices to
workers. Because §§ 19.11(a)(2) and
(a)(4) contain posting requirements
which are not relevant to early site
permits, manufacturing licenses,
standard design approvals, and standard
design certifications, the NRC
delineated in § 19.11(b) the applicable
posting requirements for those
regulatory processes. Section 19.11(c) is
reserved for future Commission use.
Sections 19.14 and 19.20 are revised
to apply to regulated entities, as well as
licensees.
Section 19.31, governing exemptions
from part 19, is revised to use language
consistent with § 50.12 and § 52.7.
Unlike the former regulation, which
limits a request for exemption to a
‘‘licensee,’’ the final rule allows
‘‘interested persons,’’ as well as
licensees to request an exemption from
one or more provisions of part 19. This
will allow applicants for and holders of
non-license regulatory vehicles in part
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52 (standard design approvals and
design certifications) to request
exemptions from part 19. The
broadened scope of persons that will be
allowed to request an exemption is
consistent with most of the exemption
provisions throughout the NRC’s
regulations in Title 10 of the CFR,
including the specific exemption
provision in part 50 (i.e., § 50.12).
Section 19.32 is revised to more
closely track the broad scope of
statutory language in Section 401 of the
1974 ERA, which is not limited to
licensing, but extends the sex
discrimination prohibition to ‘‘any
* * * activity carried on * * * under
any title’’ of the ERA. By using the
statutory language in the proposed rule,
the NRC believes that the regulations
cover not only the existing non-license
regulatory vehicles in part 52, but any
other regulatory approaches that the
NRC may adopt in the future (Section
401 of the 1974 ERA applies to NRC
regulatory activities under the AEA,
inasmuch as the 1974 ERA transferred
the AEA regulatory authority from the
old AEC to the NRC, see 1974 ERA, Sec.
104(c)).
I. Changes to 10 CFR Part 20
1. Section 20.1002, Scope
10 CFR part 20 applies to persons
licensed by the NRC to receive, possess,
use, transfer, or dispose of byproduct,
source, or special nuclear material or to
operate a production or utilization
facility. Accordingly, § 20.1002 is
revised by adding a conforming
reference to part 52, which sets forth a
process for licensing a utilization
facility.
2. Section 20.1401, General Provisions
and Scope
This section on decommissioning of
facilities is revised to add a conforming
reference to facilities licensed under 10
CFR part 52.
3. Section 20.1406, Minimization of
Contamination
Section 20.1406 requires applicants
for licenses, other than renewals, after
August 20, 1997, to describe in the
application how facility design and
procedures for operation will minimize,
to the extent practicable, contamination
of the facility and the environment,
facilitate eventual decommissioning,
and minimize, to the extent practicable,
the generation of radioactive waste. The
NRC is adding conforming changes to
§ 20.1406 in the final rule. These
conforming changes to address part 52
were inadvertently overlooked in the
proposed rule. Section 20.1406 contains
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requirements that relate both to design
and operation of a facility and therefore
applies in whole or in part to design
approvals, design certifications,
manufacturing licenses, and combined
licenses. The final rule divides
§ 20.1406 into two paragraphs.
Paragraph (a) addresses applicants for
licenses, other than early site permits
and manufacturing licenses, and
contains all of the requirements in
former § 20.1406. Paragraph (b)
addresses applicants for standard design
certifications, standard design
approvals, and manufacturing licenses
and only contains the requirements
related to design. If a combined license
applicant references a design approval,
design certification, or a reactor
manufactured under a manufacturing
license that has addressed the design
portion of this requirement under
paragraph (b), then it would only need
to address the remaining ‘‘operational’’
requirements under paragraph (a).
4. Section 20.2203, Reports of
Exposures, Radiation Levels, and
Concentrations of Radioactive Material
Exceeding the Constraints or Limits
Sections 20.2203(c) and (d) are
revised to add a reference to holders of
combined licenses to the procedures on
submitting reports.
J. Changes to 10 CFR Part 21
Part 21 implements the reporting
requirements in Section 206 of the ERA.
The proposed part 52 rule published in
2003 set forth the NRC’s proposals as to
how Section 206 reporting and,
therefore, part 21 applicability should
be extended to early site permits,
standard design certifications, and
combined licenses. However, the 2003
proposed rule did not address Section
206 reporting requirements with respect
to standard design approvals or
manufacturing licenses. Moreover, the
proposals were developed without the
benefit of the NRC’s in-depth
consideration of the issues as applied in
the context of the early site permit
applications that are currently before
the NRC. Accordingly, NRC withdrew
its earlier proposal and developed a
more complete and integrated rule on
Section 206 reporting under part 21 and
§ 50.55(e). As discussed previously,
§ 50.55(e) sets forth the Section 206
reporting requirements applicable to
holders of construction permits,
combined licenses, and manufacturing
licenses.
Key Principles of Reporting Under
Section 206 of the ERA
The NRC believes that the extension
of NRC’s reporting requirements
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implementing Section 206 of the ERA to
part 52 licensing and approval processes
should be consistent with three key
principles. First, NRC regulatory
requirements implementing Section 206
of the ERA should be a legal obligation
throughout the entire ‘‘regulatory life’’
of an NRC license, a standard design
approval, or standard design
certification. Second, reporting of
defects or failures to comply associated
with substantial safety hazards should
occur whenever the information on
potential defects would be most
effective in ensuring the integrity and
adequacy of the NRC’s regulatory
activities under part 52 and the
activities of entities 10 subject to the part
52 regulatory regime. Third, each entity
conducting activities within the scope
of part 52 should develop and
implement procedures and practices to
ensure that it fulfills its Section 206 of
the ERA reporting obligation in an
accurate and timely manner.
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First Principle—Section 206 of the ERA
Applies Throughout ‘‘Regulatory Life’’
The first principle, that NRC
regulatory requirements implementing
Section 206 must extend throughout the
entire ‘‘regulatory life’’ of a part 52
process, reflects the regulatory pattern
inherent in part 52, whereby certain
designated licenses or approvals—e.g.,
an early site permit, nuclear power
reactor manufactured under a
manufacturing license, or a design
certification—are capable of being
referenced in a subsequent nuclear
power plant licensing application.
Under the part 52 regulatory scheme, a
referenced NRC approval constitutes the
NRC’s basis for the licensing action
within the scope of the prior
Commission approval, and becomes part
of the ‘‘licensing basis’’ for that plant.
However, if Section 206 of the ERA
reflects that effective NRC decisionmaking and regulatory oversight require
accurate and timely information about
defects and failures to comply
associated with substantial safety
hazards, then Section 206 of the ERA
should apply whenever necessary to
support effective NRC decision-making
and regulatory oversight of the
referencing licenses and regulatory
approvals. To put it in different terms,
if the NRC decision that it may safely
issue a license depends in part upon an
earlier NRC safety determination for a
referenced license, standard design
approval, or standard design
10 Throughout this discussion, reference to
entities, licensees and/or applicants includes the
contractors and subcontractors of those entitles,
licensees and/or applicants.
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certification, it follows that a safety
issue with respect to the referenced
license, design approval, or design
certification has safety implications for
the referencing license or design
certification, and the continuing validity
of the NRC’s licensing decision. Thus,
the NRC concludes that the need for
Section 206 reporting should not be
limited to those licenses and approvals
under part 52 which are referenced or
‘‘relied upon’’ in a subsequent nuclear
power plant licensing application (viz.,
early site permits, standard design
approvals, standard design
certifications, and manufacturing
licenses), but rather should extend to
licenses and approvals that are capable
of being referenced in a future licensing
application. In other words, they must
extend until there can be no further
potential safety implications for a
referencing license or approval.
The NRC believes that the beginning
of the ‘‘regulatory life’’ of a referenced
license, standard design approval, or
standard design certification under part
52 occurs when an application for a
license, design approval, or design
certification is docketed. Docketing of
an application marks the start of the
NRC’s formal safety and environmental
review of the application, and therefore
the initiation of the NRC’s need for
accurate and timely information to
support its regulatory review and
approval. However, the NRC cautions
that this does not mean that an
applicant is without Section 206
responsibilities for pre-application
activities. As the NRC staff discussed in
a June 22, 2004, letter to the Nuclear
Energy Institute (NEI) (ML040430041) in
the context of an early site permit, there
are two aspects, namely, a ‘‘backward
looking’’ or retrospective aspect with
respect to existing information, and a
‘‘forward looking’’ or prospective aspect
with respect to future information. The
retrospective obligation is that the early
site permit holder and its contractors,
must report all known defects or failures
to comply in ‘‘basic components,’’ as
defined in part 21. The prospective
obligation is that the early site permit
holder and its contractors must report
all defects or failures to comply in basic
components discovered subsequent to
early site permit issuance. The early site
permit holder and its contractors are
required to meet these requirements,
and must continue to meet them
throughout the term of the early site
permit. Accordingly, safety-related
design and analysis or consulting
services should be procured and
controlled, or dedicated, in a manner
sufficient to allow the early site permit
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holder and its contractors, as applicable,
to comply with the above described
reporting requirements of Section 206,
as implemented by 10 CFR 50.55(e) and
part 21.
The NRC believes that the end of
regulatory life occurs at the later of: (1)
The termination or expiration of the
referenced license, standard design
approval, or standard design
certification; or (2) the termination or
expiration of the last of the license or
design certification directly or indirectly
referencing the (referenced) license,
design approval, or design certification.
For example, if the NRC approves a
standard design approval, which is
subsequently referenced in a final
standard design certification rule, and
that standard design certification is, in
turn referenced in a combined license
issued by the NRC, the ‘‘end’’ of the
regulatory life occurs when the
authorization to operate under the
combined license is terminated
(ordinarily, under the provisions of
§ 52.110). As long as a referenced
combined license continues to be
effective, the ‘‘regulatory life’’ of a
referenced license, standard design
approval, standard design certification,
or manufactured reactor (as applicable)
must also continue and cannot be
deemed to have ended.
Some commenters argued that the
NRC’s regulatory interests would be met
if reporting under Section 206 of the
ERA were limited to the referencing
applicant/licensee, and that there
should be no ongoing part 21 reporting
obligation imposed on the early site
permit holder, original applicant for a
standard design certification, or holder
of a part 52 regulatory approval. Under
this proposal the referencing applicant
and licensee would satisfy its obligation
by an appropriate contractual provision
between the referencing applicant/
licensee and the entity ‘‘supplying’’ the
referenced license or regulatory
approval. Although this could be a
viable alternative for some combined
licenses, early site permits, and
standard design approvals, the approach
would not be effective in the following
contexts. This approach would not
result in reporting of defects to the NRC
by the applicant of the early site permit
or standard design certification, which
violates the NRC’s second principle
(discussed more fully in the next
section). In addition, this approach
would not result in reporting where
there is no contractual relationship
between the combined license
applicant/licensee and the original
applicant of the standard design
certification. Because the approach
suggested by these commenters does not
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satisfy the NRC’s regulatory objectives,
it is not adopted.
One of the original applicants for the
current standard design certifications
stated that any arguable Section 206
requirements must logically end upon
expiration of the standard design
certification, inasmuch as expiration
marks the end time that the standard
design certification may be referenced.
The NRC disagrees with this position.
Under § 52.55(b) of the current
regulations, a standard design
certification continues to be effective in
a hearing for a combined license or
operating license docketed before the
expiration date, and in a hearing under
§ 52.103 for authority to load fuel and
operate. At minimum, the original
standard design certification applicant
should be subject to Section 206
requirements until the proceeding is
completed. Beyond the minimum
requirements, the NRC also believes that
the original design certification
applicant’s Section 206 obligations
should continue until operation is no
longer authorized in accordance with
§ 50.82(a)(2) for the last operating
license or combined license referencing
that standard design certification. The
NRC believes that the regulatory need
for information concerning defects in a
standard design certification continues
throughout the operating life of a license
referencing that design certification; the
relevance of and the NRC’s need for this
information, if subsequently discovered
by the original design certification
applicant, does not diminish simply
because the standard design
certification may no longer be
referenced.
Second Principle—Notification Occurs
When Information Is Needed
The second principle is focused on
ensuring that the NRC, its licensees, and
license applicants receive information
on defects at the time when the
information would be most useful to the
NRC in carrying out its regulatory
responsibilities under the AEA, and to
the licensee or applicant when engaging
in activities regulated by the NRC. A
result of this principle is that reporting
may be delayed if there is no immediate
consequence or regulatory interest in
prompt reporting, and that delayed
reporting will actually occur when
necessary to support effective, efficient,
and timely action by the NRC, its
licensees and applicants. Applying the
second principle and its result to part 52
processes, the NRC believes that
immediate reporting is required
throughout the period of pendency of an
application, be it a license, a standard
design approval, or a standard design
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certification. Allowing an applicant to
delay the reporting of a defect would
appear to be inconsistent with the
NRC’s statutory mandate to provide
adequate protection to public health and
safety and common defense and
security. Even if delayed reporting
would allow the NRC an opportunity to
modify its prior safety finding with
respect to the license, design approval,
or design certification, the delayed
consideration is inconsistent with one
of the fundamental purposes of part 52,
viz., to provide for early consideration
and resolution of issues in a manner
that avoids the potential for delay
during licensing of a facility.
Accordingly, the Commission has
determined that the NRC’s requirements
implementing Section 206 of the ERA
must extend to applicants (and their
contractors and subcontractors) for all
part 52 processes (licenses, early site
permits, design approvals, and design
certifications). Some commenters stated
that part 21 should not apply to
applicants and claimed that the NRC’s
proposal was contrary to the ERA. For
the reasons stated previously, the
Commission does not agree with that
position. However, once an application
has been granted, the Commission has
decided that immediate reporting of
subsequently-discovered defects is not
necessary in certain circumstances. For
those part 52 processes which do not
authorize continuing activities required
to be licensed under the AEA, but are
intended solely to provide early
identification and resolution of issues in
subsequent licensing or regulatory
approvals, the reporting of defects or
failures to comply associated with
substantial safety hazards may be
delayed until the time that the part 52
process is first referenced. The
Commission’s view is based upon its
determination that a defect with respect
to part 52 processes should not be
regarded as a ‘‘substantial safety
hazard,’’ because the possibility of a
substantial safety hazard becomes a
tangible possibility necessitating NRC
regulatory interest only when those part
52 processes are referenced in an
application for a license, such as a
combined license or manufacturing
license.
Some commenters believe that these
reporting requirements should not apply
to a holder of an early site permit or a
vendor of a standard design until the
ESP or standard design is referenced in
a COL application. As stated previously,
the Commission agrees that reporting
may be delayed until the approval,
certification, or permit is referenced.
After referencing, the holder (or in the
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49423
case of a design certification, the
applicant who submitted the
application leading to the final design
certification regulation) must make the
necessary notifications to the NRC as
well as provide final engineering. The
notification must address the period
from the Commission adoption of the
final design certification regulation up
to the filing of the application
referencing the final design certification
regulations. Thereafter, notice must be
made in the ordinary manner. The
notification obligation ends when the
last license referencing the design
certification is terminated.
Third Principle—Procedures and
Practices Must Be Implemented To
Ensure Accurate and Timely Reporting
The third principle (viz., each entity
conducting activities under the purview
of part 52, should develop and
implement procedures and practices to
ensure that the entity accurately and
timely fulfils its reporting obligation as
delineated in the NRC’s regulations), is
intended to ensure the effectiveness of
each entity’s reporting processes. This is
especially true where there is a potential
for substantial passage of time between
the discovery of a defect and the
reporting of the defect, as may be
allowed by the NRC consistent with the
second principle. For example,
following issuance of a final standard
design certification regulation, if the
original applicant determines that there
is a substantial safety hazard, that
applicant need not report the discovery
until the time that the design
certification rule is referenced—which
may be as long as 15 years from the date
of the final rule. Given the substantial
time that may pass between the time of
discovery and the date of reporting, it is
imperative that the original standard
design certification applicant develop
and implement procedures from the
time of effectiveness of the final design
certification regulations.
The result of the third principle,
consistent with part 21’s current
requirements, is that licensees, license
applicants, and other entities seeking a
design approval or design certification,
must have contractual provisions with
their contractors, subcontractors,
consultants, and other suppliers which
notify them that they are subject to the
NRC’s regulatory requirements on
reporting and the development and
implementation of reporting procedures.
This result is set forth in §§ 21.31 and
50.55(e)(7).
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Division of Implementing Requirements
Between Part 21 and § 50.55(e)
Under the Commission’s current
regulatory structure, persons and
entities engaged in construction (or the
functional equivalent of construction)
are subject to reporting requirements
under § 50.55(e). Persons and entities
engaged in all other activities within the
purview of Section 206 of the ERA are
subject to the requirements in part 21
and/or § 50.55(e). The revised part 21
and § 50.55(e) reflect the Commission’s
determination to retain this divided
regulatory structure. The NRC believes
that the only part 52 processes that
authorize ‘‘construction’’ or its
functional equivalent are manufacturing
licenses and combined licenses before
the Commission makes the finding
under § 52.103(g). Therefore, the
reporting requirements with respect to
Section 206 of the ERA for
manufacturing licenses and combined
licenses before the Commission makes
the finding under § 52.103(g) are
contained in § 50.55(e). The
requirements in part 21 apply after the
Commission makes the finding under
§ 52.103(g) for a combined license. Part
21 was revised to explicitly apply to the
remaining part 52 processes, i.e., early
site permits, standard design approvals,
and standard design certifications. Table
A–1 provides a summary of the
applicability of part 21 and § 50.55(e) to
each of the various approvals under part
52.
TABLE A–1.—APPLICABILITY OF NRC REQUIREMENTS IMPLEMENTING SECTION 206 OF THE ENERGY REORGANIZATION
ACT TO PART 52 LICENSING AND APPROVAL PROCESSES
Applicable NRC requirement implementing section 206 of the ERA
Part 52 licensing or approval processes
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Early Site Permit (ESP)
Application .............................................................................................
Issuance of ESP ...................................................................................
Standard Design Approval (SDA)
Application .............................................................................................
Issuance of SDA ...................................................................................
Standard Design Certification Rule (DCR)
Application .............................................................................................
Final DCR Rulemaking .........................................................................
Combined License (COL)
Application .............................................................................................
COL before § 52.103 Authorization .......................................................
COL after § 52.103 Authorization ..........................................................
Manufacturing License (ML)
Application .............................................................................................
Issuance of ML ......................................................................................
Reporting Requirements for Early Site
Permits
If the ESP holder becomes aware of a
significant safety concern with respect
to its site (e.g., that the specified site
characteristics for seismic acceleration
is less than the projected acceleration
due to new information), the concern
should be reported to the NRC so that
it may be considered in the review of
any future application referencing the
ESP. As stated previously, the reporting
may be delayed until the ESP is
referenced. This reporting attains
special importance given the NRC’s
proposal not to impose an updating
requirement for ESP information other
than that related to emergency
preparedness. In order for the applicant
for an ESP to have the capability to
report to the NRC any known significant
safety concerns with respect to its site,
or any safety concerns of which it may
subsequently become aware (i.e., to be
able to report any defects or failures to
comply associated with substantial
safety hazards under part 21) the ESP
applicant would have to have a program
in place for implementing the
requirements of 10 CFR part 21. The
applicant’s program may be inspected
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21.62
21.62
part 21 ..............................................
part 21 ..............................................
21.61
21.61
21.62
21.62
part 21 ..............................................
part 21 ..............................................
21.61
21.61
21.62
21.62
50.55(e) ............................................
50.55(e) ............................................
part 21 ..............................................
50.110
50.110
21.61
50.111
50.111
21.62
50.55(e) ............................................
50.55(e) ............................................
50.110
50.110
50.111
50.111
In accordance with 10 CFR 21.31, the
purchaser of a basic component must
state in the procurement documents for
the basic component that part 21 is
applicable to that procurement. As
explained previously, services that are
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21.61
21.61
Applicability of Part 21 to Contractors
or Subcontractors of an ESP Applicant
or Holder
Frm 00074
Civil
part 21 ..............................................
part 21 ..............................................
by the NRC as part of the application
review. Approval of the ESP application
would be subject to approval of the part
21 program.
Some commenters claimed that there
is no practicable method for ESP
applicants or holders to determine
whether an error in siting information
creates a substantial safety hazard and,
therefore, part 21 should not be
applicable to ESP applicants or holders.
The Commission does not agree with
this position. As stated previously, the
ESP holder and its contractors can
determine defects or failures to comply
with ‘‘basic components,’’ as defined in
part 21. This information is necessary in
order to support effective NRC
decisionmaking and regulatory
oversight of the referencing licenses and
approvals.
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required to support an early site permit
application (e.g., geologic or seismic
analyses, etc.) that are safety-related and
could be relied upon in the siting,
design, and construction of a nuclear
power plant, are to be treated as basic
components as defined in part 21.
Therefore, these services must be either
purchased as basic components,
requiring the service provider to have an
appendix B to part 50 QA program, as
well as its own part 21 program, or the
early site permit applicant could
dedicate the service in accordance with
part 21, which requires the dedication
process itself to be controlled under an
appendix B to part 50 QA program.
Reporting Requirements for Standard
Design Approvals
A standard design approval represents
the NRC staff’s determination regarding
the acceptability of the design for a
nuclear power reactor (or major portions
thereof). Although a standard design
approval does not represent the NRC’s
final determination as to the
acceptability of the design, it
nonetheless represents a substantial
expenditure of agency resources in
reviewing the design. A standard design
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approval may be referenced in a
subsequent application for a design
certification, construction permit,
operating license, combined license, or
manufacturing license. Accordingly,
consistent with the first principle, the
final rule imposes requirements
implementing Section 206 of the ERA
on applicants for and holders of
standard design approvals.
A standard design approval does not
authorize construction of a nuclear
power plant; it merely constitutes the
NRC staff’s approval of the design of a
nuclear power reactor (or major portion
thereof). Therefore, the requirements
implementing Section 206 of the ERA,
which are applicable to standard design
approvals, were placed in part 21, as
opposed to § 50.55(e).
Reporting Requirements for Standard
Design Certification Regulations
A standard design certification
represents the NRC’s approval by
rulemaking of an acceptable nuclear
power reactor design, which may then
be referenced in a subsequent combined
license or manufacturing license
application. Consistent with the first
principle, the Commission imposed
Section 206 of the ERA reporting
requirements on applicants for design
certifications, including applicants
whose designs are certified in a final
design certification rulemaking. As with
a standard design approval, a design
certification does not actually authorize
construction. Accordingly, the NRC
revised §§ 21.2, 21.3, 21.21, 21.51, and
21.61 to explicitly refer to an applicant
for a standard design certification,
rather than § 50.55(e).
Some commenters have asserted that
because there is no ‘‘holder’’ or licensee,
the NRC is without authority under
Section 206 of the ERA to impose part
21 and/or § 50.55(e) evaluation and
reporting requirements on applicants for
standard design certification. The NRC
disagrees with this assertion. The statute
by its terms does not limit its reach to
licensees; rather, the statute applies to
any individual or responsible officer of
a firm ‘‘constructing, owning, operating,
or supplying the components of any
facility or activity which is licensed or
otherwise regulated * * *.’’ The NRC
believes that an applicant for a standard
design certification, by submitting its
application, is constructively
‘‘supplying’’ a ‘‘component’’ (the
nuclear power plant) for use in a future
‘‘facility * * * licensed’’ by the NRC.
One of the consequences of the design
certification provisions in part 52 is the
ability of the applicant to subsequently
offer its design with additional, valueadded services. Thus, applying for and
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facilitating NRC adoption of a final
standard design certification regulation
is simply a partial step in the overall
activity of ‘‘supplying’’ the certified
design to potential nuclear power plant
license applicants. Alternatively, one
could treat the standard design
certification applicant as supplying a
component of an ‘‘activity’’ which is
‘‘otherwise regulated’’ by the NRC.
Under this interpretation, the ‘‘activity
* * * otherwise regulated by the NRC’’
can be viewed as the design certification
rulemaking, and/or the entire part 52
regulatory regime whereby a design
certification rule is referenced in a
subsequent licensing application. The
NRC concludes that under either
interpretation, Section 206 of the ERA
provides ample statutory authority for
the NRC to impose regulations
implementing Section 206 on design
certification applicants, during the
pendency of the application before the
NRC, as well as after NRC adoption of
a final design certification regulation
(for those applicants whose application
is granted).
As with standard design approvals, a
standard design certification does not
authorize construction of a nuclear
power plant; it constitutes the NRC’s
approval of the design of a nuclear
power plant. Therefore, the
requirements implementing Section 206
of the ERA which are applicable to
design certifications were placed in part
21, as opposed to § 50.55(e).
Reporting Requirements for Combined
Licenses
A combined license authorizes both
construction of a nuclear power plant,
and loading of fuel and operation if the
NRC makes the findings specified in
§ 52.103. As such, the application of the
first and second principles to combined
licenses is the most straightforward of
all the part 52 processes. Under the final
rule, the NRC’s requirements
implementing Section 206 of the ERA
would apply throughout the regulatory
life of the combined license, i.e., from
docketing of the application until
termination of the combined license.
To maintain the current division
between § 50.55(e) and part 21 with
respect to NRC requirements
implementing Section 206 of the ERA,
the NRC revised § 50.55(e) to make its
provisions applicable to each holder of
a combined license under part 52 before
the effective date of the NRC’s finding
under § 52.103(g), and to revise part 21
to clarify that its provisions apply to
each holder of a combined license on
the effective date of the Commission’s
authorization under § 52.103(g).
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Reporting Requirements for
Manufacturing Licenses
Under subpart F of part 52, a
manufacturing license would constitute
both the NRC’s approval of a final
nuclear power reactor design, as well as
approval to manufacture one or more
reactors in accordance with approved
programs and procedures. The
manufactured reactors would then be
transported offsite and incorporated into
nuclear power facilities by holders of
combined licenses—who may be
different entities than the holder of a
manufacturing license. Given the
possibility that the manufacturing
license holder is different from the
combined license holder whose facility
uses the manufactured reactor, the NRC
believes that the combined license
holder must be kept informed of any
significant issue with design or
manufacture of the reactor, to ensure
that they evaluate the significance of
these matters for their facility and
undertake any necessary action to
assure public health and safety and
common defense and security.
Furthermore, unlike a standard design
certification, the financial resources
necessary to obtain a manufacturing
license will, as a practical matter, result
in manufacturing beginning
immediately after issuance of the
manufacturing license. There will be no
interim period similar to a design
certification where there is no activity
occurring under the manufacturing
license. Accordingly, in compliance
with the first and second principles, the
NRC proposes that Section 206 of the
ERA requirements should apply
continuously from the filing of the
application, until the manufacturing
license expires or is otherwise
terminated by the NRC.
A manufacturing license holder
would essentially be conducting the
same activities as a construction permit
holder, albeit with several differences.11
Nonetheless, the NRC believes that
manufacturing is similar to construction
such that the NRC’s requirements
implementing Section 206 of the ERA
which are applicable to manufacturing
licenses, are contained in § 50.55(e).
11 These key differences are, first, the design of
the manufactured plant would be approved before
manufacturing commences, unlike the historical
practice with construction permits. Second, a single
manufacturing license may authorize the
manufacture of multiple reactors, with the
manufacturing process to be accomplished in a
controlled setting rather than as a ‘‘field’’ operation.
This is unlike the historical approach where nonstandardized nuclear power facilities were
constructed onsite using a ‘‘roving’’ workforce.
Third, the manufacturing license will specify the
inspections, tests, and acceptance criteria for
determining successful manufacturing.
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Accordingly, the NRC revised § 50.55(e)
to specifically apply its provisions to
holders of manufacturing licenses.
K. Change to 10 CFR Part 25
1. Section 25.35, Classified Visits
Part 25 sets forth the NRC’s
requirements governing the granting of
access authorization to classified
information to certain individuals.
Section 52.35, which requires that
licensees and certificate holders
minimize the number of classified
visits, did not, by its terms, apply to
applicants for standard design
certifications, and applicants for or
holders of standard design approvals.
Accordingly, § 25.35 is revised to refer
to an applicant for a standard design
certification under part 52 (including
the applicant after the NRC adopts a
final standard design certification rule),
and the applicant for or holder of a
standard design approval under part 52.
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L. Changes to 10 CFR Part 26
1. Section 26.2, Scope, § 26.10, General
Performance Objectives; and Appendix
A to Part 26
Part 26, which sets forth the NRC’s
requirements governing fitness-for-duty,
currently uses a two-part regulatory
regime for the application of fitness-forduty requirements. A holder of an
operating license for a nuclear power
plant is required to implement all of the
provisions in part 26. By contrast, a
holder of a construction permit is
required to comply with §§ 26.10, 26.20,
26.23, 26.70, and 26.73, and also
implement a chemical testing program,
including random tests, and make
provisions for employee assistance
programs, imposition of sanctions,
appeals procedures, the protection of
information, and record keeping.
The NRC has extended the
applicability of parts 26 to 52, in
keeping with the existing two-part
regulatory regime, so that the full array
of requirements in part 26 apply to a
combined license holder after the date
that the NRC authorizes makes the
finding under § 52.103(g), analogous to
holder of an operating license under
part 50. By contrast, holders of
combined licenses, before the date that
the NRC makes the § 52.103(g) findings,
are required to comply with the part 26
provisions currently applicable to
construction permit holders. Similarly,
holders of manufacturing licenses under
subpart F of part 52 are treated the same
as holders of construction permits.
Finally, persons authorized to conduct
the limited construction activities
allowed under § 50.10(e)(3) are also
treated the same as a construction
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permit holder. The final rule
accomplishes this by: (1) Revising
§ 26.2(a) to refer to combined license
holders after the date that the NRC
makes the finding under § 52.103(g); (2)
revising § 26.2(c) to refer to a holder of
a combined license before the date that
the NRC makes the finding under
§ 52.103(g), a holder of a manufacturing
license under subpart F of part 52, and
a person authorized to conduct the
activities under § 50.10(e)(3); (3)
revising § 26.10(a) to refer to the
personnel of a holder of a
manufacturing license and those
authorized to conduct the activities
under § 50.10(e)(3); and (4) revising
appendix A to part 26, paragraph 1.1(1)
to include a reference to a holder of
combined license after the date that the
NRC makes the finding under
§ 52.103(g).
The NRC believes that part 26 need
not be extended to cover applicants for
and holders of early site permits,
standard design approvals, and
applicants for standard design
certifications. These activities present
less of a concern with respect to public
health and safety, and common defense
and security, as compared with
construction permits, manufacturing
licenses, operating licenses, and
combined licenses. None of these
regulatory approvals or design
certification regulations authorize the
construction, manufacture, or operation
of a facility, nor do they authorize
possession of special nuclear material
(SNM). The adverse impacts on public
health and safety or common defense
and security attributable to any fitnessfor-duty issues are likely to be of a much
lower level of significance, as compared
to issues that may occur during
construction, manufacture, operation, or
possession of SNM. The NRC believes
that the potential benefits of imposing
the fitness-for-duty requirements are not
justified in view of the regulatory
burden to be imposed upon such
applicants and holders. Accordingly,
these requirements will not be imposed
on applicants for and holders of
standard design approvals and
applicants for standard design
certifications under part 52.
M. Changes to 10 CFR Part 51
The NRC is making several
conforming changes to part 51 to clarify
the environmental protection
regulations applicable to the various
part 52 licensing processes.
NEPA Compliance for Design
Certifications
For each of the four design
certification rules in appendices A, B, C,
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and D of part 52, the NRC prepared an
environmental assessment which: (1)
Provides the bases for a Commission
finding of no significant environmental
impact (FONSI) for issuance of the
design certification regulation; and (2)
identifies and addresses the need for
incorporating SAMDAs into the design
certification rule. Based upon this
experience, the NRC is making changes
to part 51 to accomplish two objectives.
First, the NRC is eliminating the need
for the NRC to prepare essentially
repetitive discussions in environmental
assessments supporting a FONSI on
issuance of a final standard design
certification regulation. Each of the
environmental assessments and FONSIs
prepared to date conclude that there is
no significant environmental impact
associated with NRC issuance of a final
design certification regulation because a
design certification does not authorize
either the construction or operation of a
nuclear power facility. Design
certification represents the NRC’s preapproval of the design for the nuclear
power facility, but does not authorize
manufacture or construction. For the
design certification to have practical
effect, it must be referenced in an
application for a combined license. The
NRC is revising part 51 to eliminate the
need for the NRC to make repetitive
findings of no significant environmental
impact for future design certifications
and amendments to design
certifications.
Second, the NRC is requiring that
SAMDAs be addressed at the design
certification stage. SAMDAs are
alternative design features for
preventing and mitigating severe
accidents, which may be considered for
incorporation into the proposed design.
The SAMDA analysis is that element of
the severe accident mitigation
alternatives analysis dealing with design
and hardware issues. At the design
certification stage, the NRC’s review is
directed at determining if there are any
cost beneficial SAMDAs that should be
incorporated into the design, and if it is
likely that future design changes would
be identified and determined to be costjustified in the future based on cost/
benefit considerations. It is most cost
effective to incorporate SAMDAs into
the design at the design certification
stage. Retrofitting a SAMDA into a
design certification once site-specific
design and engineering for a nuclear
power facility have been completed
would increase the cost of
implementing a SAMDA. The
retrofitting costs continue to increase in
ensuing stages of facility construction
and operation. For these reasons, the
NRC believes that environmental
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assessments for design certifications
should address SAMDAs. However,
under the former provisions of part 51,
both the environmental information
submitted by the design certification
applicant, and the environmental
assessment prepared by the NRC, are
directed either at determining whether
an EIS must be prepared, or that a
FONSI is justified. Accordingly, the
NRC is requiring that SAMDAs be
addressed in environmental reports and
environmental assessments for design
certifications.
The NRC is making a number of
changes to accomplish these two
objectives. The NRC is redesignating
existing § 51.55 as § 51.58, and is adding
new § 51.55 to indicate that an
environmental report submitted by the
design certification applicant must be
directed towards addressing the costs
and benefits of possible SAMDAs, and
presenting the bases for not
incorporating identified SAMDAs into
the design to be certified. The
environmental report for an applicant
seeking to amend an existing design
certification would be somewhat
narrower by focusing on if the design
change which is the subject of the
amendment, renders a SAMDA
previously rejected to become costbeneficial, and if the design change
results in the identification of new
SAMDAs that may be reasonably
incorporated into the design
certification.
The NRC is revising § 51.30 to provide
for a new § 51.30(d) establishing the
scope of an environmental assessment
for a design certification. The NRC is
adding §§ 51.32(b)(1) and (2) to set forth
the NRC’s generic determination of no
significant environmental impact
associated with issuance of a final or
amended design certification rule. This
is, essentially, the legal equivalent of a
categorical exclusion. The NRC is
including an explicit statement of no
significant environmental impact in
§ 51.32. The NRC believes that external
stakeholders will better understand the
nature of the Commission’s action by
doing so. The NRC is modifying § 51.31
by adding § 51.31(b) specifying the
information on the environmental
assessment to be included in the
proposed rulemaking on the design
certification published in the Federal
Register.
The NRC is revising § 51.50(c)(2) to
indicate that if a combined license
application references a design
certification then the combined license
applicant’s environmental report may
reference the SAMDA discussion in the
design certification environmental
assessment as part of its SAMDA
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analysis, but must contain information
demonstrating that the site
characteristics for the combined license
site falls within the site parameters in
the design certification environmental
assessment.12
Finally, the NRC is adding
§ 51.75(c)(2) to provide that if a
combined license application references
a design certification, then the
combined license EIS will incorporate
by reference the design certification
environmental assessment, and
summarize the SAMDA analysis and
conclusions of the environmental
assessment.
NEPA Compliance for Manufacturing
Licenses
The NRC believes that its current
approach for meeting the Commission’s
NEPA responsibilities for standard
design certifications should be extended
to manufacturing licenses for nuclear
power reactors. Under subpart F to part
52, a manufacturing license is similar to
a standard design certification in that a
final nuclear power reactor design
would be approved. Therefore, the NRC
is requiring that the environmental
effects of construction and operation of
a nuclear power facility using a
manufactured reactor would be
addressed in the EIS for the combined
license application for a nuclear power
facility using a manufactured reactor,
rather than in an environmental
assessment or EIS at the manufacturing
license stage.
Further, the NRC does not believe that
NEPA requires the NRC to address the
environmental impacts of actually
manufacturing a nuclear power reactor
licensed under subpart F of part 52,
either at the manufacturing license stage
or at the combined license stage where
an application proposes to use a
manufactured reactor. The
manufacturing license approves the
final design of the manufactured reactor,
the organization and technical
procedures for designing and
manufacturing the reactor, and the
ITAAC that are to be used by the
licensee in determining whether the
reactor has been properly manufactured
in accordance with NRC requirements
and the manufacturing license, and the
possession (but not the use or transport
12 The design certification applicant may have
chosen to specify site parameters for the design
certification safety review under § 52.79 which
differ from the site parameters specified in the
environmental report for its design. If such a design
certification is referenced in a combined license
application, the combined license applicant must
demonstrate that the two differing sets of site
parameters are met, in order for the full panoply of
issue finality provisions in § 52.63 to apply in the
combined license proceeding.
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offsite) of the manufactured reactor. The
manufacturing license does not approve
any specific location, building, or
facility where the actual manufacture of
the reactors may occur,13 and the NRC
does not require the applicant for the
manufacturing license to submit any
information on these matters as part of
its application. These matters are
commercial matters generally unrelated
to the NRC’s regulatory jurisdiction. The
Federal Aviation Administration (FAA)
does not prepare an EIS when issuing a
production certificate under 14 CFR part
21, subpart G, authorizing the
production of an aircraft or component
in conformance with a type certificate.
See Federal Aviation Agency Order
1050.1E, Sec. 308c (June 8, 2004).
Because the NRC does not approve any
specific location or facility in which to
manufacture any component of or the
reactor licensed under the
manufacturing license, it would be
speculative for the NRC to describe and
assess the environmental impacts of
manufacturing. NEPA does not require
that an EIS address speculative impacts.
The NRC also notes that EISs prepared
in the past for construction permits and
operating licenses under part 50, as well
as current environmental assessments
for nuclear power plant license
amendments, have never considered the
offsite environmental impacts of
fabricating systems and components by
vendors and subcontractors, even for
circumstances where the fabrication
activities are subject to NRC regulatory
jurisdiction (e.g., under applicable
provisions of parts 19 and 21). For these
reasons, the NRC concludes that NEPA
does not require the NRC to address,
either at the manufacturing license stage
or at the combined license stage where
the application proposes to use a
manufactured reactor, the speculative
impacts of manufacturing a reactor
offsite at a location or in a facility not
specified or approved in the
manufacturing license.
The NRC is making a number of
changes to part 51, in some cases
parallel to those described previously
with respect to design certifications,
consistent with its views on
manufacturing licenses. The NRC is
revising existing § 51.54 to clarify that
an environmental report for a
manufacturing license must address the
costs and benefits of SAMDAs and the
bases for not incorporating SAMDAs
13 A reactor manufactured outside of the United
States would not be within the scope of a
manufacturing license under subpart F of part 52,
by virtue of proposed § 52.9, which states that no
license shall be deemed to have been issued for
activities which are not under or within the
jurisdiction of the United States.
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into the design of the reactor to be
manufactured, and to state that the
environmental report need not address
the impacts of manufacturing a reactor
under the manufacturing license. The
NRC is removing both § 51.20(b)(6),
which formerly required preparation of
an EIS for issuance of a manufacturing
license, and § 51.76, which formerly
addressed the subject matter of an EIS
for a manufacturing license, from part
51.
The NRC is revising § 51.30(e) to
establish the scope of an environmental
assessment prepared for a
manufacturing license. The NRC is
adding §§ 51.32(b)(3) and (4) to state the
NRC’s generic determination of no
significant environmental impact
associated with issuance of a final or
amended manufacturing license. As
with the parallel provisions governing
design certifications in § 50.32(b)(1) and
(2), the NRC is including an explicit
statement of no significant
environmental impact for
manufacturing licenses in § 51.32(b)(3)
and (4) to facilitate external
stakeholders’ understanding of the
nature of the Commission’s action. The
NRC is adding § 51.31(c) to describe the
NRC’s process for determining the
manufacturing license with respect to
environmental issues covered by NEPA.
The NRC is adding § 51.50(c)(3) to
provide that if a combined license
application proposes using a
manufactured reactor, then the
combined license environmental report
may incorporate by reference the
environmental assessment for the
manufacturing license under which the
reactor is to be manufactured and, if so,
must include information demonstrating
that the site characteristics for the
combined license site fall within the site
parameters specified in the
manufacturing license environmental
assessment. This section also states that
the environmental report need not
address the environmental impacts
associated with manufacturing the
reactor under the manufacturing license.
Finally, the NRC is adding
§ 51.75(c)(3) to indicate that if the
proposed combined license application
to use a manufactured reactor and the
site characteristics of the combined
license’s site fall within the site
parameters specified in the
manufacturing license environmental
assessment,14 then the combined license
14 Analogous to design certifications, it is possible
that an applicant for a manufacturing license may
have chosen to specify site parameters for the
manufacturing license safety review under § 52.79
which differ from the site parameters specified in
the environmental report for its design. If the
combined license application proposes to use such
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EIS must incorporate by reference the
manufacturing license environmental
assessment. As in the case where the
combined license application references
a design certification, § 51.75(c)(3)
requires the combined license EIS to
summarize the findings and conclusions
of the environmental assessment with
respect to SAMDAs. Finally,
§ 51.75(c)(3) explicitly provides that the
combined license EIS will not address
the environmental impacts of
manufacturing the reactor under the
manufacturing license.
NEPA Obligations Associated With
§ 52.103(g) Findings on ITAAC
Formerly, neither part 51 nor subpart
C of part 52 explicitly addressed
whether an environmental finding
under NEPA is needed in connection
with an NRC finding under § 52.103(g)
that combined license ITAAC have been
met. Nor does part 51 or subpart C of
part 52 explicitly address whether
contentions on environmental matters
may be admitted in a hearing under
§ 52.103(b). The NRC never intended to
make an environmental finding in
connection with the § 52.103(g) finding
on ITAAC, and the NRC does not
believe that NEPA requires such a
finding. The § 52.103(g) finding that
ITAAC have been met is not a ‘‘major
Federal action significantly affecting the
environment.’’ The major Federal action
occurs when the NRC issues the
combined license, which includes the
authority to operate the nuclear power
plant—subject to an NRC finding of
successful completion of ITAAC. This is
the reason why the environmental
impacts of operation under the
combined license are evaluated and
considered by the NRC in determining
whether to issue the combined license
even under the former provisions of part
52, see § 52.89. By contrast, the scope
and nature of the NRC finding that
ITAAC have been met is constrained by
the ITAAC itself (indeed, the NRC has
always recognized the possibility that
ITAAC could be written such that the
‘‘inspections and tests’’ exception in
Section 554(a)(3) of the APA could be
invoked to preclude the need to provide
an opportunity for hearing on
§ 52.103(g) findings). The safety
consequences of operation are not
considered when making the § 52.103(g)
findings; these issues are addressed by
the NRC in determining whether to
issue the combined license in the first
place. Therefore, the NRC does not view
a manufactured reactor, then the combined license
applicant must demonstrate that the two differing
sets of site parameters are met, in order for the full
division of issue finality provisions in § 52.171 to
apply in the combined license proceeding.
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the § 52.103(g) finding as constituting a
‘‘major Federal action,’’ and makes no
environmental findings in connection
with that finding. It, therefore, follows
that no contentions on environmental
matters should be admitted in any
hearing under § 52.103(b).
Accordingly, the NRC is adding
§ 51.108 to clarify that: (1) The
Commission will not make any
environmental findings in connection
with the finding under § 52.103(g); and
(2) contentions on any environmental
matters, including the adequacy of the
combined license EIS and any
referenced environmental assessment,
may not be admitted into any
§ 52.103(b) hearing on compliance with
ITAAC. Those issues are essentially
challenges to the continuing validity of
the combined license or any referenced
design certification or manufacturing
license. Accordingly, these challenges
should be raised with the Commission
using relevant Commission-established
processes for requesting Commission
action. A challenge on environmental
grounds with respect to the combined
license or manufacturing license must
be filed under the provisions of § 2.206.
A challenge to an existing design
certification on environmental grounds
must be filed as a petition for
rulemaking to modify the existing
design certification under subpart H of
part 2.
NEPA Compliance for Combined
Licenses Referencing an Early Site
Permit
The NRC has made several changes in
the final rule based on public comments
regarding the requirements for a
combined license application
referencing an early site permit and
further consideration of the NRC’s
obligations under NEPA for such
actions. Several commenters believed
that an ESP and COL met the definition
of ‘‘connected actions,’’ under NEPA
case law and Council on Environmental
Quality (CEQ) regulations, and should
therefore not require the preparation of
a new EIS for the second of the two
connected actions, or a revalidation of
previous findings if neither the
applicant nor others identify new and
significant information. Commenters
stated that under applicable NEPA case
law, there was no requirement to
prepare a new EIS for the latter of the
two connected actions that were
previously evaluated together in a single
EIS. The commenters stated that the EIS
prepared at the ESP stage serves as the
EIS for issuance of both the ESP and
COL. Commenters stated that the ESP
EIS included an evaluation of the
environmental impacts related to
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issuance of a COL inasmuch as it
considered the environmental impact of
plant construction and operation.
The NRC continues to believe that it
is not necessary to require that all topics
be covered in a single EIS at the ESP
stage, and that topics such as alternative
energy sources and need for power may
be treated in an EIS supplement at the
COL application stage when the detailed
planning for the project is completed.
As the commenters note, new and
significant information may also prompt
the preparation of a supplement to the
ESP EIS in connection with the COL
application. Since the NRC believes that
some issues may not be ripe for
consideration at the ESP stage, and an
ESP EIS need not address such issues,
the Commission is declining to take a
position on whether the granting of an
ESP and the granting of a COL
referencing that ESP are connected
actions. Nevertheless, the Commission
believes that, inasmuch as an early site
permit and a combined license are
major Federal actions significantly
affecting the quality of the human
environment, both actions require the
preparation of an EIS. However, 10 CFR
part 52 does provide finality for
previously resolved issues. Under
NEPA, the combined license
environmental review is informed by
the EIS prepared at the ESP stage and
the NRC staff intends to incorporate by
reference the ESP EIS in the combined
license supplemental EIS. A description
of what the combined license applicant
must address in this situation can be
found under the discussion of changes
to § 51.50(c)(1).
More specific changes to individual
sections in part 51 are discussed as
follows:
rwilkins on PROD1PC63 with RULES2
1. Section 51.20, Criteria for and
Identification of Licensing and
Regulatory Actions Requiring
Environmental Impact Statements
The NRC is revising § 51.20(b) to
identify the part 52 licensing processes
that require an EIS or a supplement to
an EIS. Specifically, the NRC is revising
§ 51.20(b)(1) to indicate that issuance of
an early site permit requires an EIS. The
NRC is revising § 51.20(b)(2) to indicate
that issuance of a combined license
requires an EIS. Also, paragraph (b)(6) is
being removed and reserved because,
under the Commission’s proposed
revision to the requirements for
manufacturing licenses, only an
environmental assessment is required at
this stage.
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2. Section 51.22, Criterion for
Categorical Exclusion; Identification of
Licensing and Regulatory Actions
Eligible for Categorical Exclusion or
Otherwise Not Requiring Environmental
Review
The NRC is revising § 51.22(c) to
identify part 52 licensing processes that
are eligible for categorical exclusion or
otherwise do not require environmental
review.
3. Section 51.23, Temporary Storage of
Spent Fuel After Cessation of Reactor
Operation—Generic Determination of
No Significant Environmental Impact
The NRC is revising §§ 51.23(b) and(c)
to indicate that the provisions of these
paragraphs also apply to combined
licenses.
4. Section 51.26, Requirement To
Publish Notice and Conduct Scoping
Process
The NRC is adding a new paragraph
(d) to this section to provide
requirements for publication of a notice
of intent when the NRC determines that
a supplement to an EIS will be
prepared. This new provision also states
that, in such cases, the NRC staff need
not conduct a scoping process,
provided, however, that if scoping is
conducted, then the scoping must be
directed at matters to be addressed in
the supplement. If scoping is conducted
in a proceeding for a combined license
referencing an ESP under part 52 , then
the scoping must be directed at matters
to be addressed in the supplement as
described in § 51.92(e).
5. Section 51.27, Notice of Intent
The NRC is adding a new paragraph
(b) to this section to provide
requirements for the contents of a notice
of intent when the NRC determines that
a supplement to an EIS will be
prepared. Paragraph (b) states that the
notice of intent will, among other
things, describe the matters to be
addressed in the supplement to the final
EIS and describe any proposed scoping
process that the NRC staff may conduct.
6. Section 51.29, ScopingEnvironmental Impact Statement and
Supplement to Environmental Impact
Statement
The NRC is revising paragraph (a)(1)
of this section in the final rule to
include requirements for supplements
to an ESP EIS prepared for a combined
license application.
7. Section 51.45, Environmental Report
The NRC is revising § 51.45(c) to
indicate that the analysis in an
environmental report prepared for an
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49429
ESP need not include consideration of
the economic, technical, and other
benefits and costs of the proposed
action and of energy alternatives. This
change is being made for consistency
with the provisions of § 51.50(b), which
state that an environmental report
included in an ESP application need not
include an assessment of the benefits
(e.g., need for power) of the proposed
action and with the Commission’s
denial of a Petition for Rulemaking (See
PRM–52–02 (October 28, 2003; 68 FR
55905)).
8. Section 51.50, Environmental
Report—Construction Permit, Early Site
Permit, or Combined License Stage
The NRC is revising the title of § 51.50
to ‘‘Environmental Report Construction
Permit, Early Site Permit, or Combined
License Stage,’’ and including separate
paragraphs with specific requirements
for environmental reports for early site
permit and combined license
applications which are based on
existing requirements in part 51 for
construction permits and operating
licenses and requirements for early site
permits and combined licenses in part
52.
The NRC is revising the requirements
from former § 52.17(a)(2) to clarify that
an early site permit applicant has the
flexibility of either addressing the
matter of alternative energy sources in
the environmental report supporting its
early site permit application, or
deferring consideration of alternative
energy sources to the time that the early
site permit is referenced in a licensing
application. The NRC believes the
former regulations already afforded the
early site permit applicant such
flexibility, inasmuch as former
§ 52.17(a)(2) stated that the
environmental report submitted in
support of an early site permit
application must ‘‘focus on the
environmental effects of construction
and operation of a reactor, or reactors
* * *.’’ The environmental report’s
discussion of alternative energy sources
does not, per se, address the
‘‘environmental effects of construction
and operation of a reactor,’’ which is
one of the matters which must be
addressed in an environmental impact
statement (EIS). [See 10 CFR 51.71(d);
National Environmental Policy Act of
1969 (NEPA), Sec. 102(2)(C)(i), (ii), and
(v).] Rather, alternative energy sources
constitute part of the discussion of
reasonable alternatives to the proposed
action, which is required by Section
102(2)(C)(iii) of NEPA. [See 10 CFR
51.71(e) n.4; 46 FR 39440 (August 3,
1981) (proposed rule that would
eliminate consideration of need for
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power and alternative energy sources at
operating license stage), at 39441 (first
column) (final rule published March 26,
1982; 47 FR 12940).] See Exelon
Generation Company, LLC et al., CLI–
05–17, 62 NRC 5, where the
Commission ruled that:
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[T]he ‘‘reasonable alternatives’’ issue does
not apply with full force to ESP (or ‘‘partial’’
construction permit) cases. At the ESP stage
of the construction permit process, the
boards’ ‘‘reasonable alternatives’’
responsibilities are limited because the
proceeding is focused on an appropriate site,
not the actual construction of a reactor. Thus,
boards must merely weigh and compare
alternative sites, not other types of
alternatives (such as alterative energy
sources). (Id. at 48 (citations omitted).)
Accordingly, the NRC believes that
former § 52.17(a)(2) already provided
the early site permit applicant the
flexibility of choosing to defer
consideration of alternative energy
sources to the time that the early site
permit is referenced in a combined
license or a construction permit
application. The revisions in § 51.50(b)
clarify that the early site permit
applicant may either include a
discussion of alternative energy sources
in its environmental report, or defer
consideration of the matter. The NRC
made conforming amendments
elsewhere in part 51 to clarify that the
NRC’s EIS need not address the need for
power or alternative energy sources (and
therefore these matters may not be
litigated) if the early site permit
applicant chooses not to address these
matters in its environmental report. The
environmental report and EIS for an
early site permit must address the
benefits associated with issuance of the
early site permit (e.g., early resolution of
siting issues, early resolution of issues
on the environmental impacts of
construction and operation of a
reactor(s) that fall within the site
characteristics, and ability of potential
nuclear power plant licensees to ‘‘bank’’
sites on which nuclear power plants
could be located without obtaining a
full construction permit or combined
license). The benefits (and impacts) of
issuing an early site permit must always
be addressed in the environmental
report and EIS for an early site permit,
regardless of whether the early site
permit applicant chooses to defer
consideration of the benefits associated
with the construction and operation of
a nuclear power plant that may be
located at the early site permit site. This
is because the ‘‘benefits * * * of the
proposed action’’ for which the
discussion may be deferred are the
benefits associated with the
construction and operation of a nuclear
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power plant that may be located at the
early site permit site; the benefits which
may be deferred are entirely separate
from the benefits of issuing an early site
permit. The proposed action of issuing
an early site permit is not the same as
the ‘‘proposed action’’ of constructing
and operating a nuclear power plant for
which the discussion of benefits
(including need for power) may be
deferred under § 51.50(b).
The NRC is further modifying
§ 51.50(b) in the final rule based on
public comments. This section
addresses requirements for
environmental reports at the early site
permit stage. In the proposed rule,
§ 51.50(b) stated that environmental
reports ‘‘must focus on the
environmental effects of construction
and operation of a reactor, or reactors,
which have characteristics that fall
within the postulated site parameters.’’
Commenters pointed out that the use of
‘‘postulated site parameters’’ was not
consistent with the terminology the
NRC had used elsewhere in the
proposed rule. Consequently, the NRC is
revising this provision in the final rule
to require that the environmental report
‘‘must focus on the environmental
effects of construction and operation of
a reactor, or reactors, which have design
characteristics that fall within the site
characteristics and design parameters
for the early site permit application.’’ A
similar change is being made to the
same language in final rule § 51.75(b)
[proposed § 51.71(d)].
The NRC is making additional
changes to § 51.50(b) to further clarify
the scope of the environmental review
at the early site permit stage. Final
§ 51.50(b)(2) states that an early site
permit environmental report may
address one or more of the
environmental effects of construction
and operation of a reactor, or reactors,
which have design characteristics that
fall within the site characteristics and
design parameters for the early site
permit application, but that the
environmental report must address all
environmental effects of construction
and operation necessary to determine
whether there is any obviously superior
alternative to the site proposed. The
purpose of this change is to clearly
delineate that the scope of the
environmental review at the early site
permit stage is, at a minimum, to
address all issues needed for the NRC to
perform its evaluation of the alternative
sites. In addition, the applicant may
choose to address one or more issues
related to construction and operation of
the facility with the goal of achieving
finality on those issues at the early site
permit stage.
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In addition, the NRC is modifying
§§ 51.50(b) and 51.50(c) in the final rule
to reflect comments made at the NRC’s
public workshops during the public
comment period on the proposed rule.
These discussions related to the
requirement to include a proposed list
of activities and a redress plan in
license applications that request
authority to perform activities under
§ 50.10(e). The NRC concluded that it is
preferable to include both the list of
proposed activities and the redress plan
as separate documents in the
application, outside of both the final
safety analysis report (or site safety
analysis report in the case of an early
site permit) and the environmental
report. The NRC’s conclusion is based
on the fact that the requirements in
§ 50.10(e) address both safety and
environmental issues. Additional
changes were made to §§ 52.17(c),
52.79(a), and 52.80 to implement this
concept.
The NRC is also revising § 51.50(c)
based on public comments in the final
rule. These revisions address the
situation where a combined license
applicant is referencing an early site
permit and provide for a clearer link to
the finality provisions in § 52.39,
eliminate language that attempted to
define ‘‘new and significant,’’ and
provide greater consistency with related
requirements elsewhere in part 51. The
revisions also provide requirements for
addressing environmental terms and
conditions. The discussion that follows
reflects the language in the final rule.
The NRC is adding a requirement in
§ 51.50(c)(1) that the applicant’s
environmental report need not contain
information or analyses submitted to the
Commission in the early site permit
environmental report or resolved in the
Commission’s early site permit
environmental impact statement, but
must contain, in addition to the
environmental information and analyses
otherwise required: (1) Information to
demonstrate that the design of the
facility falls within the site
characteristics and design parameters
specified in the early site permit; (2)
information to resolve any significant
environmental issue that was not
resolved in the early site permit
proceeding; (3) any new and significant
information for issues related to the
impacts of construction and operation of
the facility that were resolved in the
early site permit proceeding; (4) a
description of the process used to
identify new and significant information
regarding the NRC’s conclusions in the
early site permit environmental impact
statement, including a requirement that
the process use a reasonable
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methodology for identifying such new
and significant information; and (5) a
demonstration that all environmental
terms and conditions that have been
included in the early site permit will be
satisfied by the date of issuance of the
combined license. Any terms or
conditions of the early site permit that
cannot be met by the time the combined
license is issued must be set forth as
terms or conditions of the combined
license.
For an early site permit, the NRC
prepares an EIS that resolves numerous
issues within certain bounding
conditions. These issues have issue
preclusion at the combined license or
CP stage provided certain conditions are
met. A combined license or CP
application must demonstrate that the
design of the facility falls within the site
characteristics and design parameters
specified in the early site permit. In
addition, the application must include
any new and significant information for
issues related to the impacts of
construction and operation of the
facility (i.e., the issue being addressed at
the combined license stage) that were
resolved in the early site permit
proceeding. Documentation related to
the applicant’s search for new
information and its determination about
the significance of the new information
should be maintained in an auditable
form by the applicant. The NRC staff
may also use the environmental scoping
process to assist it in determining if
there is new and significant information
regarding issues that were resolved in
the early site permit proceeding.
Although the NRC is ultimately
responsible for completing any required
NEPA review under 10 CFR 51.70(b), for
example, an evaluation of the impact of
new and significant information on the
conclusions for a resolved early site
permit environmental issue, the
combined license applicant must
identify whether there is new and
significant information on such an
issue. A combined license applicant
should have a reasonable process to
ensure it becomes aware of new and
significant information that may have a
bearing on the earlier NRC conclusion,
and should document the results of this
process in an auditable form. The NRC
staff will verify that the applicant’s
process for identifying new and
significant information is effective.
The NRC, in the context of a
combined license application that
references an early site permit, has
defined the term ‘‘new’’ in the phrase
‘‘new and significant information’’ as
any information that was both (1) not
considered in preparing the ESP
environmental report or EIS (as may be
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evidenced by references in these
documents, applicant responses to NRC
requests for additional information,
comment letters, etc.) and (2) not
generally known or publicly available
during the preparation of the EIS (such
as information in reports, studies, and
treatises). For new information to be
‘‘significant,’’ it must be material to the
issue being considered, that is, it must
have the potential to affect the finding
or conclusions of the NRC staff’s
evaluation of the issue. The COL
applicant need only provide
information about a previously resolved
environmental issue if it is both new
and significant.
The combined license applicant
referencing an early site permit is also
required to provide information
sufficient to resolve any other
significant environmental issue not
considered in the early site permit
proceeding (e.g., need for power) and
the information contained in the
application should be sufficient to aid
the staff in its development of an
independent analysis (see 10 CFR
51.45).
Finally, the combined license
applicant referencing an early site
permit must demonstrate that all
environmental terms and conditions
included in the early site permit will be
satisfied by the date of issuance of the
combined license. In some cases, this
may require adding a condition to the
combined license to adequately address
the environmental issue raised in the
early site permit condition. Note that
this provision was added to § 51.50(c)(1)
in the final rule. Requirements to
include environmental conditions in an
early site permit environmental report
were addressed in the proposed rule in
§ 51.50(b), but the associated provision
to ensure any conditions included in the
permit would be met was inadvertently
left out of § 51.50(c)(1).
In the past, the NRC staff has
attempted to explain the relationship
between the environmental review of an
early site permit application to that of
a combined license application
referencing the early site permit by
analogy to the license renewal
environmental review process. The NRC
believes the analogy especially useful
because the license renewal process is
well-established and clearly understood.
Because there appears to be some
confusion regarding this analogy, NRC
believes a brief explanation of the
similarities of the two processes is
warranted.
For license renewal, the NRC
prepared a generic EIS (GEIS) that
resolved more than 60 issues for all
plants based on certain bounding
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assumptions. These were termed
Category 1 issues. If a license renewal
applicant identifies new and significant
information with respect to a Category
1 issue, it documents its assessment of
that information in its application. If the
applicant determines that this new
information is not significant, or that
there is no new information, the
applicant documents the bases for these
determinations in an auditable form and
makes the documentation available for
staff inspection. If there is new and
significant information on a Category 1
issue, the NRC staff limits its inquiry to
determine if this information changes
the Commission’s earlier conclusion set
forth in the GEIS. The NRC staff may
inquire if the applicant has a reasonable
process for identifying new and
significant information on Category 1
issues.
Similarly, in the NRC environmental
review process for a combined license
application, the combined license EIS
brings forward the Commission’s earlier
conclusions from the early site permit
EIS and articulates the activities
undertaken by the NRC staff to ensure
that an issue that was resolved can
remain resolved. If there is new and
significant information on a previously
resolved issue, then the staff will limit
its inquiry to determine if the
information changes the Commission’s
earlier conclusion. Environmental
matters subject to litigation in a
combined license proceeding mainly
include (1) those issues that were not
considered in the previous proceeding
on the site or the design; (2) those issues
for which there is new and significant
information; and (3) those issues subject
to the change or exemption processes in
10 CFR part 52.
Notwithstanding that, in the context
of renewal, the GEIS resolves Category
1 issues through rulemaking and an
early site permit resolves environmental
issues through an individual licensing
proceeding, the staff believes that the
license renewal practice is similar to the
part 52 process in which a combined
license application references an early
site permit.
The NRC has determined that a
combined license is a major Federal
action significantly affecting the quality
of the human environment and, in
accordance with 10 CFR 51.20, the NRC
must prepare an EIS on that action. If
there is no new and significant
information for matters resolved at the
ESP stage, then the staff will rely upon
(‘‘tier off’’) the ESP EIS at the combined
license stage and disclose the NRC
conclusion for matters covered in the
early site permit review. Such matters
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will not be subject to litigation at the
combined license stage.
9. Section 51.51, Uranium Fuel Cycle
Environmental Data—Table S–3
The NRC is revising § 51.51 to require
that every environmental report
prepared for the early site permit stage
or combined license stage of a lightwater-cooled nuclear power reactor use
Table S–3, Table of Uranium Fuel Cycle
Environmental Data, as the basis for
evaluating the contribution of the
environmental effects of the uranium
fuel cycle to the environmental costs of
licensing light-water-cooled nuclear
power reactors. If the application for a
combined license references an early
site permit in which the environmental
impacts and costs related to the
uranium fuel cycle were already
evaluated and resolved, then the
repetition of this information in the
environment report for the combined
license is not required unless the
applicant has identified new and
significant information regarding these
environmental impacts and costs.
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10. Section 51.52, Environmental Effects
of Transportation of Fuel and Waste—
Table S–4
The NRC is revising § 51.52 to require
that every environmental report
prepared for the early site permit stage
or combined license stage of a lightwater-cooled nuclear power reactor
contain a statement concerning
transportation of fuel and radioactive
wastes to and from the reactor. If the
application for a combined license
references an early site permit in which
the transportation of fuel and
radioactive wastes to and from the
reactor has already been evaluated and
resolved, then the repetition of this
information in the environment report
for the combined license is not
necessary unless the applicant has
identified new and significant
information regarding the associated
environmental impacts.
11. Section 51.53, Postconstruction
Environmental Reports
The NRC is revising § 51.53(a) to
clarify that any postconstruction
environmental report may incorporate
by reference any information contained
in a prior environmental report or
supplement thereto that relates to the
site or any information contained in a
final environmental document
previously prepared by the NRC staff
that relates to the site. This change
reflects the recognition that
environmental documents will be
prepared at the early site permit stage
and may be referenced in environmental
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documents for future licensing actions.
The NRC is also revising § 51.53(a) to
clarify that documents that may be
referenced in post-construction
environmental reports include those
prepared in connection with an early
site permit or a combined license. In
addition, the NRC is revising
§ 51.53(c)(3) to clarify that the
requirements for the content of
environmental reports submitted in
applications for renewal of a combined
license are the same as those for renewal
of an operating license.
12. Section 51.54, Environmental
Report—Manufacturing License
The NRC is revising this section by
adding two paragraphs to delineate the
difference in the matters with respect to
SAMDAs that must be addressed in an
environmental report for issuance of a
manufacturing license under subpart F
of part 52, versus that for an amendment
to the manufacturing license. Section
51.54(a) provides that the
environmental report for the
manufacturing license must address the
costs and benefits of SAMDAs, and the
bases for not incorporating into the
design of the manufactured reactor any
SAMDAs identified during the
applicant’s review. Section 51.54(b)
reflects the narrower scope of an
environmental report submitted in
connection with a proposed amendment
to a manufacturing license, by providing
that the report need only address
whether the design change which is
subject of a proposed amendment either
renders a SAMDA previously identified
and rejected to become cost beneficial,
or results in the identification of new
SAMDAs that may be reasonably
incorporated into the design of the
manufactured reactors.
As discussed earlier, the
environmental impacts of
manufacturing a reactor under a
manufacturing license are not
considered by the NRC, and § 51.54
indicates that the environmental report
need not include a discussion of the
environmental impacts of
manufacturing a reactor.
13. Section 51.55, Environmental
Report—Standard Design Certification
The NRC is transferring the provisions
in current § 51.55 to a new § 51.58
(discussed in § 51.58), and the NRC is
revising this section to address the
contents of environmental reports for
design certifications under subpart B of
part 52. The structure of new § 51.55 is
similar to that of § 51.54, reflecting the
fact that the environmental review for
either manufacturing licenses or design
certifications is limited to SAMDAs.
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Section 51.55(a) provides that the
environmental report for the design
certification must address the costs and
benefits of SAMDA, and the bases for
not incorporating into the design
certification any SAMDAs identified
during the applicant’s review. Section
51.55(b) provides that the
environmental report submitted in
support of a request to amend a design
certification need only address whether
the design change which is the subject
of a proposed amendment either renders
a SAMDA previously identified and
rejected to become cost beneficial, or
results in the identification of new
SAMDAs that may be reasonably
incorporated into the design
certification.
14. Section 51.58, Environmental
Report—Number of Copies; Distribution
The matters previously addressed in
§ 51.55 are addressed in a new § 51.58.
The NRC is adding conforming
references to § 51.58(a) for early site
permits and combined licenses. Section
51.58(b) contains a conforming
reference to subpart F of part 52.
15. Section 51.71, Draft Environmental
Impact Statement—Contents
The NRC is revising § 51.71(d) to
include a reference to § 51.75 in the first
sentence because § 51.75 also includes
exceptions to the provisions in
§ 51.71(d). This represents a change the
NRC is making in the final rule to move
the specific discussions on early site
permits and combined licenses from
§ 51.71(d) to their associated paragraphs
in § 51.75. The NRC is also revising
associated footnote 3 to include
references to early site permits and
combined licenses.
16. Section 51.75, Draft Environmental
Impact Statement—Construction Permit,
Early Site Permit, or Combined License
The NRC is adding §§ 51.75(b) and (c)
to include separate requirements for the
preparation of draft EISs at the early site
permit and combined license stages. In
the final rule, the NRC is also moving
information related to early site permits
that was contained in proposed
§ 51.71(d) to § 51.75(b). In addition, the
NRC is providing further clarification in
the final rule on the scope of the
environmental review at the early site
permit stage. Section 51.75 requires that
the draft environmental impact
statement must include an evaluation of
alternative sites to determine whether
there is any obviously superior
alternative to the site proposed. The
draft environmental impact statement
must also include an evaluation of the
environmental effects of construction
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and operation of a reactor, or reactors,
which have design characteristics that
fall within the site characteristics and
design parameters for the early site
permit application, but only to the
extent addressed in the early site permit
environmental report or otherwise
necessary to determine whether there is
any obviously superior alternative to the
site proposed. The purpose of this
change is to clearly delineate that the
scope of the environmental review at
the early site permit stage is, at a
minimum, to address all issues needed
for the NRC to perform its evaluation of
the alternative sites. In addition, the
applicant may choose to address one or
more issues related to construction and
operation of the facility with the goal of
achieving finality on those issues at the
early site permit stage. The NRC also
notes that, where the early site permit
application identifies a specific nuclear
power reactor design (i.e., a standard
design certification or manufacturing
license) under § 52.17(a)(1)(i), the
environmental report for an early site
permit may address the applicability of
the severe accident mitigation design
alternatives (SAMDA) evaluation for
that reactor design to the proposed site.
In this situation, the early site permit
EIS must determine whether the site
characteristics bound the site
parameters relevant to the SAMDA
analysis, as specified in the
environmental assessment for the
identified nuclear power reactor design.
The requirements for combined
licenses are organized into separate
paragraphs (c)(1), (c)(2), and (c)(3)
which address the contents of the
combined license environmental impact
statement if the combined license
application references an early site
permit or standard design certification,
or proposes to use a manufactured
reactor. For example, § 51.75(c)(3)
provides that the combined license EIS
will not address the environmental
impacts associated with manufacturing
the reactor under the manufacturing
license.
In the final rule, § 51.75(c)(1) states
that if a combined license application
references an early site permit, then the
NRC staff shall prepare a supplement to
the early site permit EIS. Paragraph
(c)(1) also requires that the supplement
be prepared in accordance with § 51.92.
Section 51.92 contains the requirements
for the content of a supplemental EIS
prepared for a combined license
application that references an early site
permit.
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17. Section 51.92, Supplement to the
Final Environmental Impact Statement
The NRC is revising § 51.92 in the
final rule to provide requirements for
NRC staff preparation of a supplement
to the final environmental impact
statement for an early site permit as
required by § 51.75(c)(1). Paragraph (b)
of § 51.92 states that, in a proceeding for
a combined license application
referencing an early site permit, the
NRC staff shall prepare a supplement to
the final environmental impact
statement for the referenced early site
permit in accordance with § 51.92(e). In
the final rule, the NRC is moving
information related to combined
licenses that was contained in proposed
§ 51.71(d) to § 51.92(e) and is revising
the wording of this provision. In the
proposed rule, § 51.71(d) stated that the
draft supplemental environmental
impact statement prepared at the
combined license stage when an early
site permit is referenced need not
include detailed information or analyses
that were resolved in the final
environmental impact statement
prepared by the Commission in
connection with the early site permit,
provided that the design of the facility
falls within the design parameters
specified in the early site permit, the
site falls within the site characteristics
specified within the early site permit,
and there is no new and significant
environmental issue or information not
considered on the site or the design only
to the extent that they differ from that
discussed in the final environmental
impact statement prepared by the
Commission in connection with the
early site permit. In the final rule, the
NRC has modified these provisions and
moved them to § 51.92(e). The revised
language in paragraph (e) provides a
clearer link to the finality provisions in
§ 52.39, eliminates language in the
proposed rule that attempted to define
‘‘new and significant,’’ and provides
greater consistency with related
requirements elsewhere in part 51.
Specifically, paragraph (e) requires that
a supplement to an early site permit
final environmental impact statement
must: (1) Identify the proposed action as
the issuance of a combined license for
the construction and operation of a
nuclear power plant as described in the
combined license application at the site
described in the early site permit
referenced in the combined license
application; (2) incorporate by reference
the final environmental impact
statement prepared for the early site
permit; (3) contain no separate
discussion of alternative sites; (4)
include an analysis of the economic,
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technical, and other benefits and costs
of the proposed action, to the extent that
the final environmental impact
statement prepared for the early site
permit did not include an assessment of
these benefits and costs; (5) include an
analysis of other energy alternatives, to
the extent that the final environmental
impact statement prepared for the early
site permit did not include an
assessment of energy alternatives; (6)
include an analysis of any
environmental issue related to the
impacts of construction or operation of
the facility that was not resolved in the
proceeding on the early site permit; and
(7) include an analysis of the issues
related to the impacts of construction
and operation of the facility that were
resolved in the early site permit
proceeding for which new and
significant information has been
identified, including, but not limited to,
new and significant information
demonstrating that the design of the
facility falls outside the site
characteristics and design parameters
specified in the early site permit.
18. Section 51.95, Postconstruction
Environmental Impact Statements
The NRC is revising § 51.95(a) to
indicate that documents that may be
referenced in a supplement to a final
environmental impact statement include
documents prepared in connection with
an early site permit or combined
license. In addition, the NRC is revising
§ 51.95(c) to add provisions for renewal
of combined licenses and to correct the
address for the NRC Public Document
Room. The NRC is revising § 51.95 to
indicate that the NRC will prepare a
supplemental environmental impact
statement in connection with the
amendment of a combined license
authorizing decommissioning activities
or with the issuance, amendment, or
renewal of a license to store spent fuel
at a nuclear power reactor after
expiration of the combined license, and
that the supplement may incorporate by
reference any information contained in
the final environmental impact
statement for the combined license or in
the records of decision prepared in
accordance with an early site permit or
combined license. Finally, the NRC is
revising § 51.95(d) to indicate that,
unless otherwise required by the
Commission, in accordance with the
provisions of § 51.23(b), a supplemental
environmental impact statement for the
post combined license stage will
address the environmental impacts of
spent fuel storage only for the term of
the license, amendment, or renewal
applied for.
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19. Section 51.105, Public Hearings in
Proceedings for Issuance of
Construction Permits or Early Site
Permits
The NRC is revising the section
heading and § 51.105(a) to indicate that
the requirements for presiding officers
in public hearings on construction
permits also apply to public hearings on
early site permits. In addition, the NRC
is adding § 51.105(b) to indicate that the
presiding officer in an early site permit
hearing shall not admit contentions
concerning the benefits assessment (e.g.,
need for power), or alternative energy
sources if the applicant did not address
those issues in the early site permit
application. This change is being made
for consistency with the provisions of
§ 51.50(b), which state that an
environmental report included in an
early site permit application need not
include an assessment of the benefits
(e.g., need for power) of the proposed
action, and with the Commission’s
denial of a Petition for Rulemaking (See
PRM–52–02 (October 28, 2003; 68 FR
55905)). The NRC notes that the
environmental report and EIS for an
early site permit must address the
benefits associated with issuance of the
early site permit (e.g., early resolution of
siting issues, early resolution of issues
on the environmental impacts of
construction and operation of a
reactor(s) that fall within the site
characteristics, and ability of potential
nuclear power plant licensees to ‘‘bank’’
sites on which nuclear power plants
could be located without obtaining a
full construction permit or combined
license). The benefits (and impacts) of
issuing an early site permit must always
be addressed in the environmental
report and EIS for an early site permit,
regardless of whether the early site
permit applicant chooses to defer
consideration of the benefits associated
with the construction and operation of
a nuclear power plant that may be
located at the early site permit site. This
is because the ‘‘benefits * * * of the
proposed action’’ for which the
discussion may be deferred are the
benefits associated with the
construction and operation of a nuclear
power plant that may be located at the
early site permit site; the benefits which
may be deferred are entirely separate
from the benefits of issuing an early site
permit. The presiding officer needs to be
mindful of whether the applicant has
addressed only the benefits of issuing
the early site permit or whether the
applicant has also addressed all of the
benefits of construction and operation of
the facility. This is because the
presiding officer, in accordance with
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§ 51.105(a)(3), must determine, after
weighing the environmental, economic,
technical, and other benefits against
environmental and other costs, and
considering reasonable alternatives,
whether the early site permit should be
issued, denied, or appropriately
conditioned to protect environmental
values. If the applicant has addressed all
of the costs and benefits associated with
construction and operation of the
facility in its environmental report, the
final balancing between costs and
benefits needs to occur at the early site
permit stage.
The NRC also notes that, where the
early site permit application identifies a
specific nuclear power reactor design
(i.e., a standard design certification or
manufacturing license) under
§ 52.17(a)(1)(i), the environmental report
for an early site permit may address the
applicability of the severe accident
mitigation design alternatives
evaluation for that reactor design to the
proposed site. In this situation, the early
site permit EIS must determine whether
the site characteristics bound the site
parameters relevant to the SAMDA
analysis, as specified in the
environmental assessment for the
identified nuclear power reactor design.
In addition, in accordance with Section
52.107(c), the presiding officer shall not
admit contentions proffered by any
party concerning severe accident
mitigation design alternatives unless the
contention demonstrates that the site
characteristics fall outside of the site
parameters in the standard design
certification or underlying
manufacturing license for the
manufactured reactor.
20. Section 51.105a, Public Hearings in
Proceedings for Issuance of
Manufacturing Licenses
The NRC is adding § 51.105a to
provide requirements for public
hearings in proceedings for issuance of
manufacturing licenses. Specifically,
§ 51.105a establishes that the presiding
officer in a proceeding for a
manufacturing license will determine
whether the manufacturing license
should be issued as proposed by the
appropriate NRC staff director.
21. Section 51.107, Public Hearings in
Proceedings for Issuance of Combined
Licenses
The NRC is adding § 51.107 to set out
the requirements for public hearings in
proceedings for issuance of combined
licenses. The requirements parallel the
associated requirements for public
hearings on construction permits and
operating licenses, as appropriate, and
provide requirements unique to the
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combined license process that are
derived from various provisions in part
52, namely §§ 52.39 and 52.103. The
NRC is making changes to the language
in § 51.107 in the final rule to more
clearly define the role of the presiding
officer in a proceeding for the issuance
of a combined license where an early
site permit is being referenced.
Specifically, paragraph (b) addresses the
situation where a combined license
application references an early site
permit and a supplement to the early
site permit environmental impact
statement is prepared in accordance
with § 51.75(c)(1) and § 51.92(e). In such
cases, the presiding officer in the
combined license hearing shall not
admit any contention proffered by any
party on environmental issues which
have been accorded finality under
§ 52.39 unless the contention: (1)
Demonstrates that the nuclear power
reactor proposed to be built does not fit
within one or more of the site
characteristics or design parameters
included in the early site permit; (2)
raises any significant environmental
issue that was not resolved in the early
site permit proceeding; or (3) raises any
issue involving the impacts of
construction and operation of the
facility that was resolved in the early
site permit proceeding for which new
and significant information has been
identified.
N. Changes to 10 CFR Part 54
1. Section 54.1, Purpose
This part applies to renewed
operating licenses for nuclear power
plants. A conforming change is made to
this section to include renewed
combined licenses.
2. Section 54.3, Definitions
The definition for renewed combined
license is added to explain the meaning
of the new phrase as it is used in this
part.
3. Section 54.17, Filing of Application
Section 54.17(c) is revised to add a
conforming reference to combined
licenses issued under 10 CFR part 52.
4. Section 54.27, Hearings
This section is revised to include a
conforming reference to renewed
combined license issued under 10 CFR
part 52.
5. Section 54.31, Issuance of a Renewed
License
Sections 54.31(a), (b), and (c) are
revised to include conforming
references to combined licenses in this
procedure on issuance of renewed
licenses.
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Part 55 establishes the NRC’s
requirements for licensing of operators
of utilization facilities in accordance
with the statutory requirements in
Section 202 of the ERA. Formerly, the
provisions in part 55 referred only to
utilization facilities licensed under part
50, and therefore, do not address
utilization facilities licensed for
operation under a combined license
issued under subpart C of part 52.
Section 202 of the ERA, however, does
not limit its mandate to operators of
facilities licensed under part 50; the
statutory requirement would also appear
to apply to operators of facilities
licensed under part 52 (i.e., combined
licenses under subpart C of part 52).
Accordingly, §§ 55.1 and 55.2 are
revised by adding a reference to part 52.
This clarifies that each operator of a
nuclear power reactor licensed under a
part 52 combined license or renewed
under part 54 must first obtain an
operator’s license under part 55. In
addition, the conforming changes clarify
that these operators, as well as holders
of combined licenses issued under part
52 or renewed under part 54, are subject
to the requirements in part 55 (e.g., part
E of part 55, Written Examinations and
Operating Tests, set forth requirements
which are directed, for the most part, at
the holders of operating licenses for
utilization facilities).
Q. Changes to 10 CFR Part 73
Part 73 establishes the NRC’s
requirements for the physical protection
of production and utilization facilities
licensed by the NRC. It provides
requirements for the physical protection
of licensed activities, for personnel
access authorization, and for criminal
history checks of individuals granted
unescorted access to a nuclear power
facility or access to Safeguards
Information. Formerly, the language of
§ 73.1, Purpose and scope, § 73.2,
Definitions, § 73.50, Requirements for
physical protection of licensed
activities, § 73.56, Personnel access
authorization requirements for nuclear
power plants, and § 73.57, Requirements
for criminal history checks of
individuals granted unescorted access
to a nuclear power facility or access to
Safeguards Information by power
reactor licensees, and Appendix C,
Licensee Safeguards Contingency Plans,
did not refer to combined licenses
issued under part 52. However, part 73
was formerly applicable to combined
licenses under the provisions of § 52.83,
Applicability of part 50 provisions,
which states that all provisions of 10
CFR part 50 and its appendices
applicable to holders of operating
licenses also apply to holders of
combined licenses. Accordingly, § 73.1
is revised to clarify that the regulations
in part 73 apply to persons who receive
combined licenses under part 52, and
§ 73.2 is revised to state that terms
defined in part 52 have the same
meaning when used in part 73. The NRC
has addressed combined licenses in
§ 73.57 by making the provisions that
are required before receiving an
operating license under part 50
applicable before the date that the
Commission makes the finding under
§ 52.103 for a combined license.
Additional conforming changes to
include part 52 licenses are made for
§§ 73.50 and 73.56, and appendix C to
part 73.
P. Changes to 10 CFR Part 72
R. Change to 10 CFR Part 75
1. Section 72.210, General License
Issued
1. Section 75.6, Maintenance of Records
and Delivery of Information, Reports,
and Other Communications
Part 75 sets forth NRC requirements
intended to implement the agreement
between the United States and the
International Atomic Energy Agency
(IAEA) with respect to safeguards of
nuclear material. Various provisions
throughout part 75 require certain
licensees and other individuals and
entities regulated by the NRC to submit
to the NRC various reports and
communications. Section 75.6 specifies
the NRC officials to whom these reports
6. Section 54.35, Requirements During
Term of Renewed License
This section is revised to include
conforming references to holders of
combined licenses and the regulations
in part 52 into the requirements for a
renewed license.
7. Section 54.37, Additional Records
and Recordkeeping Requirements
Section 54.37(a) is revised to include
a conforming reference to a renewed
combined license.
O. Changes to 10 CFR Part 55
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Part 72 sets forth the requirements for
independent spent fuel storage facilities.
This section is revised to include a
conforming reference to persons
authorized to operate nuclear power
reactors under 10 CFR part 52 (i.e., a
combined license holder).
2. Section 72.218, Termination of
Licenses
Section 72.218(b) is revised to include
a conforming reference to combined
licenses issued under part 52.
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49435
and communications are to be sent.
However, § 75.6(b)—the provision
applying to, inter alia, nuclear power
plants—refers only to holders of a
construction permit or an operating
license, and does not include holders of
combined licenses. Accordingly,
§ 75.6(b) is revised to reference
combined licenses. The NRC notes that
early site permits and manufacturing
licenses need not be referenced,
inasmuch as the U.S.–IAEA Safeguards
Agreement does not extend to early site
permits or manufacturing licenses.
S. Changes to 10 CFR Part 95
The following discussion explains the
requirements in part 95 generically and
covers §§ 95.5, 95.13, 95.19, 95.20,
95.23, 95.31, 95.33 through 95.37, 95.39,
95.43, 95.45, 95.49, 95.51, 95.53, 95.57,
and 95.59.
Part 95 sets forth the NRC
requirements governing what
individuals and entities may be
provided access to National Security
Information (NSI) and/or Restricted Data
(RD) received or developed in
connection with activities licensed,
certified, or regulated by the NRC, and
how this information and data is to be
protected by these individuals and
entities against unauthorized disclosure.
Although requirements for protection
of NSI and RD must, by statute, apply
to all individuals and entities provided
access to such information, various
sections in part 95 use slightly different
wording to delineate the relevant set of
individuals and entities. To ensure
consistency, the Commission is revising
its regulations to refer to ‘‘licensee,
certificate holder, or other person,’’ to
describe the individuals and entities
subject to the applicable requirements.
In adopting this phrase, the NRC
intends to ensure that its regulatory
requirements for protection of NSI and
RD in part 95 extend as broadly as the
NRC’s authority provided under
applicable law. The term, ‘‘licensee,’’
includes both holders of all NRC
licenses, including (but not limited to)
combined licenses, as well as holders of
permits such as construction permits
and early site permits. The term,
‘‘certificate holder,’’ includes (but is not
limited to) all certificates of approval
that the Commission may issue, such as
a certificate of compliance for spent fuel
casks under 10 CFR part 72. Finally, the
term, ‘‘or other person,’’ is intended to
include individuals and entities who are
subject to the regulatory authority of the
Commission, including applicants for
standard design approvals and standard
design certifications under part 52. For
the same reasons, the Commission is
revising § 95.39 to use the phrase, ‘‘NRC
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license, certificate, or standard design
approval or standard design certification
under part 52.’’
T. Changes to 10 CFR Part 140
Part 140 addresses the NRC
requirements applicable to nuclear
reactor licensees with respect to
financial protection and indemnity
agreements to implement Section 170 of
the AEA, commonly referred to as the
Price-Anderson Act. In general, the
indemnification and financial
protection requirements in part 140
become applicable when a holder of a
10 CFR part 50 construction permit who
also possesses a materials license under
10 CFR part 70 brings fuel onto the site.
However, part 140 did not address the
indemnification and financial
protection requirements of combined
license holders. Accordingly, the final
rule revises various sections in part 140
to address combined licenses under part
52.
The NRC does not believe that part
140 must be revised to address any part
52 licensing process other than a
combined license. Neither an early site
permit nor a manufacturing license
authorizes the possession or use of
nuclear fuel or other nuclear materials,
and the NRC would not issue these
licenses with a materials license under
part 70. The NRC also believes that part
140 need not be revised to address
standard design approvals or standard
design certifications, because neither of
these processes authorize the possession
or use of nuclear fuel or other nuclear
materials.
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U. Changes to 10 CFR Part 170
Part 170 sets out the fees charged for
licensing services performed by the
NRC. The NRC is revising § 170.2(g) and
(k) to add conforming references to
manufacturing licenses and standard
design approvals issued under part 52,
revise the existing reference to appendix
Q to part 52 to be a reference to
appendix Q to part 50, and delete the
reference to a manufacturing license
issued under part 50 (which is being
removed from part 50 because of its
transfer to part 52 in the 1989
rulemaking adopting part 52).
V. Changes to 10 CFR Part 171
Part 171 sets out the annual fees
charged to persons who hold licenses
issued by the NRC. The NRC is revising
§ 171.15 to add conforming references to
combined licenses issued under part 52.
Note that for combined licenses, the
requirements of part 171 are not
applicable until after the Commission
has made the finding under § 52.103(g).
This section also provides fee
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requirements for each person holding a
part 50 power reactor license that is in
decommissioning or possession only
status and each person holding a part 72
license who does not hold a part 50
license. The NRC also added
conforming changes to include
references in part 52 in these provisions.
VI. Section-by-Section Analysis
Part 52, General Provisions
Section 52.0 Scope; Applicability of 10
CFR Chapter I Provisions
This section, formerly designated as
§ 52.1, has been expanded to: (1)
address all licensing and regulatory
processes covered in part 52; and (2)
more clearly define the relationship
between part 52 and remaining
provisions of 10 CFR Chapter I.
Paragraph (a), which establishes the
scope of part 52, is revised by referring
to all licensing and regulatory processes
covered in part 52. In addition,
paragraph (a) is revised to give notice to
contractors, subcontractors or
consultants of applicants for or holders
of licenses or regulatory approvals
under part 52 that they are subject to
NRC enforcement action for violations
of the deliberate misconduct
proscriptions in § 52.4. The Commission
notes, as discussed below in the sectionby-section analysis of § 52.4, that
deliberate misconduct under § 52.4 may
occur as the result of a violation of any
Commission rule and regulation
throughout 10 CFR Chapter I, not just a
violation of a requirement in part 52.
Paragraph (b) is a new provision that
supersedes former § 52.83. The first
sentence of paragraph (b) is intended to
make clear that the Commission’s
regulations in 10 CFR Chapter I apply to
applicants and holders of licenses,
permits and other regulatory approvals
in part 52 (e.g., design approvals and
standard design certifications).
Accordingly, applicants, licensees and
holders of regulatory approvals under
part 52 should review the regulations in
10 CFR Chapter I to ensure that they are
in compliance with applicable
Commission requirements throughout
10 CFR Chapter I. The second sentence
of paragraph (b) reinforces the
applicability of the Commission’s
requirements throughout 10 CFR
Chapter I to part 52 licenses, permits,
and other regulatory approvals. As part
of this final rule, the Commission is
making conforming changes as
necessary throughout Chapter I to
ensure that relevant regulations clearly
set forth their applicability to part 52
licenses and approvals, and to part 52
entities such as applicants, licensees,
and holders. Nonetheless, the
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Commission is adopting paragraph (b)
in order to clearly and unambiguously
impose applicable regulatory
requirements that exist throughout 10
CFR Chapter I.
Section 52.1 Definitions
This section, formerly designated as
§ 52.2, has been supplemented by: (1)
adding definitions of terms that are used
in part 52 but were undefined in the
previous rule; and (2) providing
definitions of new terms that were
added in this rulemaking to provide
greater clarity and precision. New
definitions which are noteworthy are
discussed individually as follows.
A definition of modular design is
added to explain the type of modular
reactor design to which the Commission
intended to refer to in the second
sentence of the current § 52.103(g). This
special provision for modular designs
was added to part 52 to facilitate the
licensing of nuclear plants, such as the
Modular High Temperature Gas-Cooled
Reactor (MHTGR) and Power Reactor
Innovative Small Module (PRISM)
designs, that consisted of three or four
nuclear reactors in a single power block
with a shared power conversion system.
During the period that the power block
is under construction, the Commission
could separately authorize operation for
each nuclear reactor when each reactor
and all of its necessary support systems
were completed. The Commission
believes that the term ‘‘modular design’’
needs to be defined to aid future use of
the current § 52.103(g) by distinguishing
the intended definition from other
currently used definitions for ‘‘modular
design.’’ Also, future combined license
applicants for a multi-unit site that
would be similar to current multi-unit
sites (where each unit is similar in
design but independent of all other
units) could use this provision.
Definitions of the terms design
characteristics, design parameters, site
characteristics, and site parameters
were added to § 52.1 to clarify their
meaning and use in the licensing and
approval processes of part 52. Design
characteristics are defined as the actual
features of a nuclear reactor or reactors.
Design characteristics are specified in
the final safety analysis report for a
standard design approval, a standard
design certification, a combined license
application, or a manufacturing license.
Design parameters are defined as the
postulated features of a nuclear reactor
or reactors that could be built at the
proposed site. Design parameters are
specified in an early site permit
application. Site characteristics are
defined as the actual physical,
environmental, and demographic
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features of a site. Site characteristics are
specified in an early site permit or
combined license application. Site
parameters are defined as the postulated
physical, environmental, and
demographic features of an assumed
site. Site parameters are specified in a
standard design approval, standard
design certification, or manufacturing
license.
The values for the characteristics and
parameters will be used in the NRC’s
review of combined license applications
that reference design approvals, design
certifications, manufacturing licenses,
or early site permits. For example,
§ 52.79(b) requires that a combined
license application referencing an early
site permit contain information
sufficient to demonstrate that the actual
design characteristics of the nuclear
facility fall within the design parameters
and site characteristics specified in the
early site permit. Also, § 52.79(d)
requires that a combined license
application referencing a design
certification rule must contain
information sufficient to demonstrate
that the actual site characteristics fall
within the site parameters specified in
the design certification.
The above terms are also used in
§§ 52.39 and 52.93. Because the NRC is
relying on certain design parameters
specified in the early site permit
applications to reach its conclusions on
site suitability, these design parameters
will be included in any early site permit
issued. The NRC believes that its review
of a combined license application that
references an early site permit will
involve a comparison to ensure that the
actual characteristics of the design
chosen by the combined license
applicant fall within the design
parameters specified in the early site
permit. A combined license application
that references a design certification
will involve a comparison to ensure that
the actual characteristics of the site
chosen by the combined license
applicant fall within the site parameters
in the design certification. Similarly, if
a combined license applicant references
both an early site permit and a design
certification, the NRC will review the
application to ensure that the site
characteristics in the early site permit
fall within the site parameters in the
referenced design certification and that
the actual design characteristics fall
within the design parameters in the
early site permit.
A new definition of major features of
the emergency plans is added to explain
what aspects of emergency
preparedness—short of full and
integrated emergency plans—an early
site permit applicant may seek approval
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of under § 52.17(b)(2)(i). A major feature
may consist of a specific aspect of a plan
necessary to address in whole or part 1
or more of the 16 planning standards in
10 CFR 50.47(b). Additional
requirements for each of the planning
standards are set forth in part 50,
appendix E, and the applicant may
choose to demonstrate compliance with
one or more provisions in appendix E,
either in addition to or without a full
demonstration of compliance with a
planning standard in § 50.47(b), when
seeking approval of part of a major
feature. A major feature may also be a
description of one or both of the
emergency planning zones (EPZs)
required by 10 CFR 50.33(g). Regulatory
considerations governing EPZs are set
forth in § 50.33(g); a major feature need
not address all of these considerations.
A definition of prototype plant is
added to explain the type of nuclear
power plant that the Commission
intended in the former § 52.47(b) (new
§ 50.43), and § 52.157(e)). A prototype
plant is a licensed nuclear reactor test
facility that is similar to and
representative of either the first-of-akind or standard nuclear plant design in
all features and size, but may have
additional safety features. The purpose
of the prototype plant is to perform
testing of new or innovative safety
features for the first-of-a-kind nuclear
plant design, as well as being used as a
commercial nuclear power facility.
Section 52.2 Interpretations
This section, formerly designated as
§ 52.5, remains unchanged. It provides
that the only interpretations of part 52
that are legally binding on the
Commission are interpretations
provided by the General Counsel. These
written interpretations, which are rarely
provided by the General Counsel, are set
forth in 10 CFR part 8.
Section 52.3 Written Communications
This new section, which is analogous
to § 50.4, sets forth administrative
requirements regarding written
communications with the NRC,
including the addressing of such
communications, and listings of the
various NRC offices and officials who
must receive copies of different types of
communications (e.g., applications for
licenses and license amendments,
security plan and related submissions,
quality assurance related submissions).
The administrative requirements
themselves are identical to those in
§ 50.4; they are reproduced in § 52.3 to
make clear that they apply to applicants
for and holders of permits, licenses, and
regulatory processes that are contained
in part 52.
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Section 52.4
49437
Deliberate Misconduct
This section, formerly designated as
§ 52.9, has been substantially rewritten
in order to more clearly delineate the
applicability of the proscriptions against
deliberate misconduct to all delineated
part 52 entities, including applicants for
and holders of standard design
approvals, and applicants for standard
design certifications (including those
applicants whose designs are certified
by the Commission in a standard design
certification rulemaking). Although the
regulatory language in § 52.4 differs
from former § 52.9, no substantive
change in any aspect of the Commission
law or the underlying policy
considerations is being made by the
Commission’s adoption of § 52.4. The
relevant law and policy considerations
for former § 52.9 are merely clarified
and extended in § 52.4 to cover
applicants for and holders of permits,
licenses, and regulatory processes that
are contained in part 52.
Section 52.5
Employee Protection
This new section, which is analogous
to § 50.7, prohibits discrimination
against employees for engaging in
protected activities established in
Section 211 of the Energy
Reorganization Act of 1974, as amended
(1974 ERA). These protected activities,
which are listed in § 52.5(a)(1), include
(but are not limited to) providing the
Commission or the employer
information about alleged violations of
the AEA or 1974 ERA, of any of the
Commission’s regulations. No
substantive change in any aspect of the
Commission law or the underlying
policy considerations with respect to
employee protection is being made by
the Commission adoption of § 52.5; the
relevant law and policy considerations
for former § 50.7 are merely clarified
and extended in § 52.5 to cover
applicants for and holders of permits,
licenses, and regulatory processes that
are contained in part 52 (currently,
standard design approvals and standard
design certifications).
Section 52.6 Completeness and
Accuracy of Information
This new section, which is analogous
to § 50.9, requires that all information
submitted to the NRC by the delineated
part 52 entities be complete and
accurate, and imposes a reporting
requirement on such entities with
respect to information with respect to
the regulated activity having a
significant implication for public health
and safety or common defense and
security. No substantive change in any
aspect of the Commission law or the
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underlying policy considerations is
being made by the Commission
adoption of § 52.6; the relevant law and
policy considerations underlying § 50.9
are merely clarified and extended to
cover applicants for and holders of
permits, licenses and regulatory
processes that are contained in part 52.
For example, § 50.9 does not impose a
positive obligation on licensees to seek
out new information meeting the
reporting thresholds in the rule. In
applying § 52.6, the Commission would
extend this interpretation to part 52
entities such as combined license
holders and standard design
certification applicants (including
applicants whose applications were
approved, for the regulatory life of the
certification rule).
Section 52.7 Specific Exemptions
This new section, which is analogous
to § 50.12, provides for specific
procedures and criteria for Commission
grants of exemptions from the
provisions of part 52. No substantive
change in any aspect of the Commission
law or the underlying policy
considerations is being made by the
Commission adoption of § 52.7; the
relevant law and policy considerations
underlying § 50.12 are merely extended
to part 52.
The NRC notes that the exemption
provisions in § 52.7 do not supercede or
otherwise diminish more specific
exemption provisions that are in part
52, such as the provision of a specific
design certification rule or § 52.63(b)(1)
governing exemptions from one or more
elements of a design certification rule.
An applicant or licensee referencing a
standard design certification rule who
wishes to obtain an exemption from one
or more elements must meet the criteria
in the specific design certification rule
or § 52.63(b)(1). If the applicant or
licensee is unable to demonstrate
compliance with those criteria, then it
may request an exemption under the
more encompassing authority of § 52.7.
However, the exemption request must
then demonstrate compliance with the
additional criteria in § 52.7.
The Commission also notes that § 52.7
does not supercede the applicability of
more specific dispensation provisions in
other parts of Chapter I. For example, a
holder of a combined license would not
require a separate part 52 exemption in
order to obtain approval of an
alternative to a provision of an
applicable ASME Code provision that is
otherwise required under 10 CFR
50.55a; the licensee need only satisfy
the criteria in § 50.55a(a)(3). However,
in the absence of a more specific
dispensation provision, the Commission
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intends to utilize § 52.7 as a means for
granting dispensation from compliance
with Commission requirements in other
parts of 10 CFR Chapter I. The person
requesting an exemption need only
address the § 52.7 criteria as applied to
the underlying requirement for which
dispensation from compliance is sought,
and need not also address dispensation
from compliance with the relevant part
52 requirement. For example, the holder
of the combined license who wishes
dispensation from compliance with a
fire protection requirement in 10 CFR
50.48 need only address the relevant
criteria in § 52.7 with respect to the
reasons for dispensation from
compliance with § 50.48. The holder
need not address dispensation from
compliance with § 52.0, which
otherwise makes applicable the
provisions of § 50.48 on the licensee.
Any exemption granted by the
Commission would address the reasons
for dispensation with the underlying
requirement—in this case, § 50.48, and
would also provide dispensation from
compliance with § 52.0.
Section 52.8 Combining Licenses;
Elimination of Repetition
This new section includes provisions
analogous to §§ 50.31, 50.32, and 50.52
and is added to clarify that these
regulatory provisions also apply to part
52 licenses. Paragraph (a), which is
analogous to § 50.31, is added to make
clear that an applicant for a license
under part 52 may combine in one
application, several applications for
different kinds of licenses under various
regulations in 10 CFR Chapter I. Section
50.31 currently provides that an
applicant may combine in one
application, several applications for
different kinds of licenses under various
regulations in 10 CFR Chapter I. The
plain reading of this language, given
that this provision is located in part 50,
is that a part 50 application may contain
in one application other applications for
different licenses in other parts of 10
CFR Chapter I. Thus, § 50.31 would not
appear to allow a part 52 application (as
for a combined license) to combine in
one application other applications for
different license in other parts of 10 CFR
Chapter I. Accordingly, paragraph (a)
makes clear that a part 52 application
may be combined with application for
different licenses in other parts of 10
CFR Chapter I.
Paragraph (b), which is analogous to
§ 50.32, is added to make clear that an
applicant for a license, standard design
certification, or design approval under
part 52 may incorporate by reference in
its application information contained in
other documents provided to the
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Commission, but that such
incorporation must clearly specify the
information to be incorporated.
Paragraph (c), which is analogous to
§ 50.52, is added to clarify the
Commission’s authority under Section
161.h of the AEA to combine NRC
licenses, such as a special nuclear
materials license under part 70 for the
reactor fuel, with a combined license
under part 52. Analogous to the
situation with respect to § 50.31, the
language in § 50.52 would not appear to
allow the Commission to combine into
a single part 52 license, other non-part
52 licenses. No substantive change in
any aspect of the Commission law or the
policy considerations underlying
§§ 50.31, 50.32, and 50.52 is being made
by the Commission adoption of § 52.8;
the relevant law and policy
considerations underlying §§ 50.31,
50.32, and 50.52 are merely extended to
part 52.
Section 52.9
Jurisdictional Limits
This new section, which is analogous
to § 50.53, makes clear that no approval
provided by the Commission under part
52 addresses or approves in any manner
activities which are not under or within
the territorial jurisdiction of the United
States. As a practical matter, this means
that an approval or license issued by the
NRC under part 52 has no legal effect
outside the territorial jurisdiction of the
United States. No substantive change in
any aspect of the Commission law or the
policy considerations underlying
§ 50.53 is being made by the
Commission adoption of § 52.9; the
relevant law and policy considerations
are merely extended to part 52.
Section 52.10
Acts
Attacks and Destructive
This new section, which is analogous
to § 50.13, applies the existing
Commission law and policy that a
licensee need not provide for design
features or other measures to protect
against certain attacks and destructive
acts, or the use or deployment of
weapons incident to U.S. defense
activities, to the applicants for and
holders of permits, licenses and other
approvals under part 52. No substantive
change in any aspect of the Commission
law or the underlying policy
considerations is being made by the
Commission adoption of § 52.10; the
relevant law and policy considerations
for the § 50.13 exclusion are merely
extended to cover applicants for and
holders of permits, licenses, and
regulatory processes that are contained
in part 52.
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Section 52.11 Information Collection
Requirements: OMB Approval
This section, formerly designated as
§ 52.8, remains unchanged. It gives
notice that all information collection
and reporting requirements in part 52
have been approved by the Office of
Management and Budget. No
requirement, action or responsibility is
imposed on part 52 entities by this
section.
Subpart A—Early Site Permits
Section 52.12
Scope of Subpart
This section describes the scope of
this licensing process. Under this
subpart an applicant can request preapproval of a site (so-called site
banking), separate from other licensing
actions, and subsequently reference that
early site permit in a future application
to build a nuclear power plant. This
process was created for proposed sites
that the applicant may not plan to use
in the near term.
Section 52.13
Subparts
Relationship to Other
This section explains the relationship
of the early site permit process to the
construction permit process under 10
CFR part 50 and to the combined license
process under part 52.
Section 52.15
Filing of Applications
This section explains who can file,
how to file, and the fees for NRC review
of an application for an early site
permit.
Section 52.16 Contents of
Applications; General Information
This section sets forth the type of
general information that is required to
be included in an early site permit
application, namely, the information
required by 10 CFR 50.33(a) through (d)
and (j). Section 50.33 requires that the
application include information such as
the name and address of the applicant,
a description of the business or
occupation of the applicant, and
citizenship information of the applicant.
Section 50.33 also provides
requirements for the handling of
Restricted Data or other defense
information in an application.
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Section 52.17 Contents of
Applications; Technical Information
The purpose of this section is to set
forth the type of technical information
to be included in an application for an
early site permit. Paragraph (a)(1)
identifies the information needed for the
site safety review, excluding emergency
planning information. The site safety
information is a subset of the
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information required of applicants for
construction permits. Although an ESP
applicant does not need to specify a
particular nuclear plant design, as in
construction permit applications, it does
need to provide sufficient surrogate
design information (developed to bound
the nuclear plant design(s) that are
being considered by the applicant) so
that the NRC can make a determination
on the acceptability of the site and the
environmental impacts, and determine
whether designs bounded by the
surrogate design information provided
by the applicant can be qualified for the
proposed site. The application must
contain, among other things, the specific
number, type (e.g., pressurized-water
reactor), and thermal power level of the
facilities, or range of possible facilities,
for which the site may be used; the
anticipated maximum levels of
radiological and thermal effluents each
facility will produce; the type of cooling
systems, intakes, and outflows that may
be associated with each facility; the
boundaries of the site; and the proposed
general location of each facility on the
site. As part of the description of the
proposed general location of each
facility on the site (§ 52.17(a)(1)(v)), the
applicant should describe the foot print
for all structures and external safetyrelated design features proposed for the
site.
The application must also include the
seismic, meteorological, hydrologic, and
geologic characteristics of the proposed
site with appropriate consideration of
the most severe of the natural
phenomena that have been historically
reported for the site and surrounding
area and with sufficient margin for the
limited accuracy, quantity, and period
of time in which the historical data have
been accumulated. This information is
to ensure that future plants built at the
site would be in compliance with
General Design Criterion 2 from
appendix A to part 50, which requires
that structures, systems, and
components important to safety be
designed to withstand the effects of
natural phenomena such as earthquakes,
tornadoes, hurricanes, floods, tsunami,
and seiches without loss of capability to
perform their safety functions.
The application must also include the
location and description of any nearby
industrial, military, or transportation
facilities and routes, and the existing
and projected future population profile
of the area surrounding the site. The
application must contain an analysis
and evaluation of the major structures,
systems, and components of the facility
that bear significantly on the
acceptability of the site from a
radiological safety standpoint. In
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49439
addition, the application must
demonstrate that adequate security
plans and measures can be developed
for the site and must provide a
description of the quality assurance
program applied to site-related
activities.
Paragraph (a)(2) identifies that the
application must include an
environmental report that meets the
requirements of § 51.50(b).
Environmental reports must focus on
the environmental effects of
construction and operation of a nuclear
reactor, or reactors, which have
characteristics that fall within the
design parameters postulated in the
early site permit. Environmental reports
must also include an evaluation of
alternative sites to determine whether
there is any obviously superior
alternative to the site proposed.
Environmental reports submitted in an
early site permit application are not
required to but may include an
assessment of the economic, technical,
and other benefits and costs of the
proposed action or an analysis of other
energy alternatives.
Paragraph (b) identifies the emergency
planning information to be included in
the application. All ESP applicants are
required to identify in the site safety
analysis report (SSAR) physical
characteristics unique to the proposed
site that could pose a significant
impediment to the development of
emergency plans, e.g., a physical
characteristic or combination of
physical characteristics that could pose
major difficulties for evacuation or the
taking of other protective actions. In
addition, if the applicant identifies such
physical characteristics, the application
must identify measures that would,
when implemented, mitigate or
eliminate the significant impediment.
After meeting this mandatory
requirement, paragraph (b) allows
applicants the option of either
submitting major features of emergency
plans or complete and integrated
emergency plans for approval by the
NRC, in consultation with the
Department of Homeland Security
(DHS). For complete and integrated
emergency plans, the applicant must
include the proposed inspections, tests,
and analyses that the holder of a
combined license referencing the early
site permit shall perform, and the
acceptance criteria that are necessary
and sufficient to provide reasonable
assurance that, if the inspections, tests,
and analyses are performed and the
acceptance criteria met, the facility has
been constructed and will operate in
conformity with the license, the
provisions of the Atomic Energy Act,
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and the NRC’s regulations. The
inclusion of such inspections, tests,
analyses, and acceptance criteria
(ITAAC) is necessary to allow the NRC
to make the finding that the plans
submitted by the applicant provide
reasonable assurance that adequate
protective measures can and will be
taken in the event of a radiological
emergency. Paragraph (b) also allows
applicants proposing major features of
emergency plans to include proposed
ITAAC. Where the applicant is
submitting a complete and integrated
emergency plan, a utility plan must be
submitted if any offsite agencies elect
not to participate in the development of
emergency planning information.
If the applicant plans to perform the
preparations for construction activities
identified in 10 CFR 50.10(e)(1), then
paragraph 52.17(c) requires the
applicant to describe the activities it is
requesting to perform and propose a
redress plan that, if carried out, would
achieve a ‘‘self-maintaining,
environmentally stable, and
aesthetically acceptable site’’ that
conforms to local zoning laws. Redress
plans are expected to be modeled on the
redress requirements imposed on the
Clinch River Breeder Reactor project
(see In the Matter of the U.S.
Department of Energy, et al., LBP–85–7,
21 NRC 507 (1985)). By containing a
redress plan, the ESP will constitute
assurance that, if site preparation
activities are conducted but the site is
never used for a nuclear power plant,
the site will be returned to an acceptable
and stable condition.
Section 52.18
Applications
Standards for Review of
This section identifies the regulations
that the NRC staff will use in performing
its review of an application for an early
site permit, including the standards that
the NRC staff will use in performing its
assessment of emergency preparedness
information provided in the ESP
application.
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Section 52.21 Administrative Review
of Applications; Hearings
This section identifies the procedural
requirements that apply to the
mandatory hearing for the early site
permit licensing process. This section
also clarifies that the applicant’s
environmental report is not required to
but may include an assessment of the
benefits of construction and operation of
the reactor or reactors, or an analysis of
alternative energy sources. In addition,
the presiding officer in an ESP hearing
is prohibited from admitting
contentions on these matters if those
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issues were not addressed in the early
site permit application.
Section 52.23 Referral to the Advisory
Committee on Reactor Safeguards
(ACRS)
This section states that the ACRS will
report on those portions of the
application which concern safety which
is the same role the ACRS had with
respect to construction permits in the
past.
Section 52.24
Permit
Issuance of Early Site
The purpose of this section is to set
forth the timing of issuance of an ESP
and the findings that the Commission
must make to issue the ESP, including
that issuance of the permit will not be
inimical to the common defense and
security or to the health and safety of
the public, that the applicant is
technically qualified to engage in
activities necessary to prepare the ESP
application and any site preparation
activities that the applicant is seeking
approval to perform, and that the
findings required by subpart A of 10
CFR part 51 regarding the NRC staff’s
assessment of the environmental impact
have been made.
This section also requires that the
early site permit specify the site
characteristics, design parameters, and
terms and conditions of the early site.
Before issuance of either a construction
permit or a combined license
referencing an early site permit, the
Commission must find that any relevant
terms and conditions of the early site
permit have been met. Any terms or
conditions that could not be met by the
time of issuance of the construction
permit or combined license must be set
forth as terms or conditions of the
construction permit or combined
license. Finally, this section requires
that the early site permit specify the site
preparation activities under § 52.17(c)
that the permit holder is authorized to
perform.
Section 52.25
Permitted
Extent of Activities
This section specifies that, if the
construction preparation activities
authorized by § 52.24(c) are performed
and the site is not referenced in a
application for a construction permit or
a combined license while the permit
remains valid, then the early site permit
remains in effect for the purpose of site
redress with the goal of achieving an
environmentally stable and aesthetically
acceptable site.
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Section 52.27
Duration of Permit
The purpose of paragraph (a) of this
section is to specify the duration of an
early site permit. The applicant can
request a duration of up to 20 years.
Paragraph (b) describes the conditions
under which an ESP can continue to be
valid beyond its expiration date.
Paragraph (c) allows an applicant for a
construction permit or combined
license, at its own risk, to reference an
ESP that is under review by the NRC but
not yet granted. Paragraph (d) explains
that, upon issuance of a construction
permit or combined license, a
referenced early site permit is
subsumed, to the extent referenced, into
the construction permit or combined
license. By ‘‘subsumed’’ the NRC means
that the information that was contained
in the early site permit SSAR becomes
part of the referencing combined license
FSAR upon issuance of the combined
licenses in the same manner as if the
combined license applicant had not
referenced an early site permit. The
NRC is including the phrase ‘‘to the
extent referenced,’’ to indicate that it is
not all of the information submitted in
the early site permit application that is
subsumed into the combined license,
but, rather, only that information that is
contained in the SSAR and identified by
the applicant as being referenced in the
combined license application. This
subsumption of the early site permit
into the referencing license affects the
way changes to the early site permit
information will be handled because it
breaks the tie to the finality provisions
in § 52.39. After issuance of the
construction permit or combined
license, § 52.39 no longer applies to the
early site permit information and such
information will be covered by the same
finality provisions as the rest of the
information in the FSAR (with the
exception of any referenced design
certification information), as outlined in
§ 52.98 (e.g., in accordance with
§§ 50.54, 50.59, etc.).
Section 52.28
Permit
Transfer of Early Site
This section specifies the
requirements to be followed if a holder
of an early site permit wants to transfer
the ESP to another person or company.
Section 52.29
Application for Renewal
Paragraph (a) of this section explains
the contents and timing of an
application for renewal of an early site
permit. Paragraph (b) sets forth the
procedure for requesting a hearing on
the application for renewal. Paragraph
(c) explains that an ESP may remain in
effect beyond its expiration under
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certain circumstances. Specifically, an
ESP for which a timely application for
renewal has been filed remains in effect
until the Commission has determined
whether to renew the permit. If an ESP
is not renewed, it continues to be valid
in any proceeding on an application for
a construction permit or a combined
license which references the ESP and
was docketed prior to the expiration of
the ESP. Finally, paragraph (d)
identifies the responsibilities of the
ACRS on an ESP renewal application.
Section 52.31 Criteria for Renewal
Paragraph (a) of this section sets forth
the criteria for granting a renewal of an
early site permit and provides that, if
the NRC wants to impose new
requirements, it must demonstrate that
the new requirements meet the backfit
standard from § 50.109. Paragraph (b)
explains that even if an application for
renewal of an ESP is denied by the NRC,
the applicant can submit a new
application for an ESP that corrects the
problems with the application for
renewal.
Section 52.33 Duration of Renewal
This section specifies the duration of
a renewed early site permit. An ESP
may, upon application, be extended for
periods of up to 20 years beyond the
previously approved duration, provided
the criteria in § 52.31 are met.
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Section 52.35 Use of Site for Other
Purposes
The purpose of this section is to
explain how the holder of an early site
permit could use the site for other
activities. An approved site may be used
for purposes not related to the
construction of a nuclear power facility,
e.g., a fossil-fueled station or a park,
provided that the Commission is
informed of all significant non-nuclear
uses prior to actual construction or site
modification activities. A permit may be
revoked if a non-nuclear use would
interfere with a nuclear use, or would so
alter the site that important assumptions
underlying the issuance of the permit
were called into question.
Section 52.39 Finality of Early Site
Permit Determinations
This section specifies the special
backfit requirements that apply to an
early site permit. Paragraph (a) provides
requirements regarding finality of ESP
issues as they relate to the Commission.
Paragraph (a)(1) states that,
notwithstanding any provision in 10
CFR 50.109 (Backfitting), while an early
site permit or renewed early site permit
is in effect, the Commission may not
change or impose new site
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characteristics, design parameters, or
terms and conditions, including
emergency planning requirements, on
the early site permit unless the
Commission meets one of four
conditions. Those conditions are that
the Commission either determines that
a modification is necessary to bring the
permit or the site into compliance with
the Commission’s regulations and
orders applicable and in effect at the
time the permit was issued; determines
that a modification is necessary to
assure adequate protection of the public
health and safety or the common
defense and security; determines that a
modification is necessary based on an
update under § 52.39(b); or issues a
variance requested under § 52.39(d).
Paragraph (a)(2) addresses the finality
of an early site permit for a license that
references the early site permit and
requires that the Commission treat as
resolved those matters resolved in the
proceeding on the application for
issuance or renewal of the early site
permit, except as provided for in
§§ 52.39(b), (c), and (d). This paragraph
also addresses finality of changes to an
early site permit approved emergency
plan (or major features thereof).
Paragraph (b) requires a license
applicant that references an ESP to
update and correct the emergency
preparedness information that was
provided in the ESP and to discuss
whether the new information materially
changes the bases for compliance with
the applicable NRC requirements. New
information which materially changes
the bases for compliance includes: (1)
Information which substantially alters
the bases for a previous NRC conclusion
with respect to the acceptability of a
material aspect of emergency
preparedness or an emergency
preparedness plan, and (2) information
which would constitute a sufficient
basis for the Commission to modify or
impose new terms and conditions
related to emergency preparedness, in
accordance with § 52.39(a)(1). New
information which materially changes
the Commission’s determination of the
matters in § 52.17(b), or results in
modifications of existing terms and
conditions by the NRC under
§ 52.39(a)(1) would be subject to
litigation during the licensing
proceedings in accordance with
§ 52.39(c).
Section 52.39(c) provides
requirements for the submittal of
contentions in a proceeding for the
issuance of a license referencing an
early site permit and for the filing of
petitions requesting that an early site
permit be modified, suspended, or
revoked. Paragraph (c)(1) states that
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contentions on several matters may be
litigated in the proceeding on a
combined license that references an
early site permit. Matters that may be
litigated include contentions related to
the following: (1) The nuclear power
reactor proposed to be built does not fit
within one or more of the site
characteristics or design parameters
included in the early site permit; (2) one
or more of the terms and conditions of
the early site permit have not been met;
(3) a variance requested under § 52.39(d)
is unwarranted or should be modified;
(4) new or additional information is
provided in the application that
substantially alters the bases for a
previous NRC conclusion or constitutes
a sufficient basis for Commission to
modify or impose new terms and
conditions related to emergency
preparedness; or (5) any significant
environmental issue that was not
resolved in the early site permit
proceeding, or any issue involving the
impacts of construction and operation of
the facility that was resolved in the
early site permit proceeding for which
significant new information has been
identified. An issue related to the
impacts of construction and operation of
the facility resolved in the early site
permit proceeding is afforded finality at
the combined license stage provided
that there is no ‘‘new and significant’’
information on the issue. If an
environmental issue was not resolved at
the early site permit stage, either
because information was not sufficient
to resolve it or because the early site
permit applicant was permitted to defer
it (e.g., need for power analysis), then
the combined license applicant would
need to address the issue in its
combined license application. The NRC,
in the context of a combined license
application that references an early site
permit, has defined the term ‘‘new’’ in
the phrase ‘‘new and significant
information’’ as any information that
was both (1) not considered in preparing
the ESP environmental report or EIS (as
may be evidenced by references in these
documents, applicant responses to NRC
requests for additional information,
comment letters, etc.) and (2) not
generally known or publicly available
during the preparation of the EIS (such
as information in reports, studies, and
treatises). This new information may or
may not be significant. For an issue to
be significant, it must be material to the
issue being considered, i.e., it must have
the potential to affect the NRC staff’s
evaluation of the issue. The COL
applicant need only provide
information about a previously resolved
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environmental issue if it is both new
and significant.
Paragraph (c)(2) allows any person to
file a petition requesting that the site
characteristics, design parameters, or
terms and conditions of the early site
permit be modified, or that the permit
be suspended or revoked. The petition
will be considered in accordance with
§ 2.206. Section 2.206 provides that any
person may file a request to institute a
proceeding to modify, suspend, or
revoke a license, or for any other action
as may be proper. Section 52.39(c)(2)
addresses the Commission’s required
action on such a petition and states that
construction under the construction
permit or combined license will not be
affected by the granting of the petition
unless the Commission makes the order
immediately effective.
Paragraph (d) provides that an
applicant for a license or an amendment
to such a license who has filed an
application referencing an early site
permit may request a variance from one
or more site characteristics, design
parameters, or terms and conditions of
the early site permit, or from the SSAR.
This paragraph also states that, once a
construction permit or combined license
referencing an early site permit is
issued, a variance from the early site
permit will not be granted for that
construction permit or combined
license. At that point, the early site
permit is subsumed into the combined
license and any request for a change to
the terms or conditions of the combined
license is a request for a license
amendment that must be filed under the
provisions of § 50.90.
The NRC is adding new paragraph (e)
in the final rule in response to public
comments expressing support for
adding provisions to provide an early
site permit holder with the option of
requesting an amendment to the early
site permit in order to resolve issues
that were not addressed in the original
early site permit review or to achieve
finality on updated early site permit
information. Paragraph (e) states that the
holder of an early site permit may not
make changes to the early site permit,
including the SSAR, without prior
Commission approval. The request for a
change to the early site permit must be
in the form of an application for a
license amendment, and must meet the
requirements of 10 CFR 50.90 and 50.92.
The NRC considers an early site permit
SSAR to be equivalent to a combined
license FSAR; therefore, when an early
site permit is amended, the SSAR must
be revised consistent with the ESP
amendments. In addition, the SSAR
retains continuing viability for early site
permits that are for multiple units after
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it is referenced in the first combined
license. However, unlike an FSAR, there
is no change process for the SSAR that
does not require NRC review and
approval.
Finally, the Commission is adding a
new paragraph (f) (proposed paragraph
(e)) to the ‘‘finality’’ section in each
subpart of part 52, including § 52.39,
entitled ‘‘Information requests,’’ which
delineates the restrictions on the NRC
for information requests to the holder of
the early site permit. This provision is
analogous to the former provision on
information requests in paragraph 8 of
appendix O to parts 50 and 52, and is
based upon the language of § 50.54(f).
For early site permits, this provision is
contained in § 52.39(f), and requires the
NRC to evaluate each information
request on the holder of an early site
permit to determine that the burden
imposed by the information request is
justified in light of the potential safety
significance of the issue to be addressed
in the information request. The only
exceptions would be for information
requests seeking to verify compliance
with the current licensing basis of the
early site permit. If the request is from
the NRC staff, the request would first
have to be approved by the Executive
Director for Operations (EDO) or his or
her designee.
Subpart B—Standard Design
Certifications
Section 52.41
Scope of Subpart
This section describes the scope of
this licensing process for certification of
standard nuclear power plant designs.
Under this subpart, an applicant may
request pre-approval of either an
evolutionary light-water or advanced
nuclear power plant design, separate
from a site review or other licensing
action, and subsequently reference that
certified design in an application to
build a nuclear power plant. The
requirements for the type of plant to be
certified were moved from § 52.45 to
this section. The scope of the standard
plant design must be essentially
complete as described in § 52.47(c).
Section 52.43
Subparts
Relationship to Other
The purpose of this section is to
explain the relationship of the design
certification process to the processes set
forth in subparts C, E, and F of 10 CFR
part 52, which provide for combined
licenses, standard design approvals, and
manufacturing licenses. The
requirement to hold a final design
approval under former appendix O to
part 52 as a prerequisite to design
certification was deleted from § 52.45.
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However, applicants for design
certification have the option of also
applying for a standard design approval
under subpart E. Also, applicants for a
manufacturing license may reference a
certified design.
Section 52.45 Filing of Applications
This revised section is similar to the
‘‘filing of applications’’ sections in
subparts A and C of this part. This
section explains how to file an
application for design certification and
how the fees for NRC’s review of the
application will be assessed. Because
design certification is a rule and not a
license, the applicant for design
certification does not need to be a U.S.
citizen or company (AEA, Section 103).
Section 52.46 Contents of
Applications; General Information
This is a new section and it is similar
to the ‘‘general information’’ sections in
subparts A and C of this part. It
identifies the general information that
must be included in all applications.
Section 52.47 Contents of
Applications; Technical Information
The purpose of this section is to
identify the technical information that
must be included in an application for
design certification. This section was
revised to provide a comprehensive list
of requirements for a design certification
application. Paragraphs (a) and (c)
describe the information that must be
included in the FSAR, which is
included in the application, and
paragraph (b) describes the information
that must also be included in the
application but does not need to be
included in the FSAR. Paragraph (c)
describes additional requirements for
particular types of applications. This
section also specifies the level of detail
for the design information that must be
provided in an application.
Many of the requirements in this
section were taken from 10 CFR 50.34
or are pointers to technical requirements
in parts 20, 50, 51, and 73 that must be
addressed in the application. The
requirements taken from § 50.34 are a
subset of the information required of
applicants for construction permits and
operating licenses. Other requirements
came from the original version of 10
CFR 52.47 or were developed by the
Commission during the initial design
certification reviews (e.g., SECY–93–
087, ML003708021).
Although an applicant for design
certification does not need to specify a
particular site for the nuclear power
plant, as in a combined license
application, it does need to identify the
site parameters, under paragraph (a)(1),
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that the standard nuclear power plant is
designed to meet, e.g., postulated values
for the safe-shutdown earthquake
response spectra and maximum tornado
wind speed. These parameters are
usually selected to envelop a large
portion of existing nuclear plant sites in
the United States. Once the design is
certified by the NRC, conformance of
the actual site with the established site
parameters must be demonstrated by the
applicant for a combined license and
verified by the NRC when the
application is submitted.
Paragraph (a)(7) requires the applicant
for design certification to describe its
qualifications to design and analyze a
standard nuclear power plant, which
may become part of the bases for a
future license.
Paragraph (a)(13) requires the
applicant to provide the electric
equipment list required by § 50.49(d).
The NRC understands that the applicant
may not be able to establish
qualification files for all applicable
components.
In its staff requirements memorandum
(SRM) on SECY–90–377, ‘‘Requirements
for Design Certification under 10 CFR
part 52,’’ dated February 15, 1991, the
Commission directed the staff to ensure
that the design certification process
preserves operating experience insights
in the certified design. Therefore, for
plant designs that are based on or are
evolutions of nuclear plants that have
operated in the United States, paragraph
(a)(22) requires the applicant to
demonstrate how relevant operating
experience insights, from NRC’s generic
letters and bulletins issued after the
most recent revision of the applicable
SRP and 6 months before the docket
date of the application, have been
incorporated into the plant design.
Operating experience includes
consideration of operating events and
the reliability and performance of
structures, systems, and components. If
the application is for a design that is not
based on or is not an evolution of a
nuclear plant that operated in the
United States, the applicant must
demonstrate how insights from any
relevant international operating
experience have been incorporated into
that plant design.
In its SRMs, dated June 26, 1990, and
July 21, 1993, on SECY–90–16,
‘‘Evolutionary Light-Water Reactor
Certification Issues and their
Relationship to Current Regulatory
Requirements,’’ and SECY–93–087,
‘‘Policy, Technical, and Licensing Issues
Pertaining to Evolutionary and
Advanced Light-Water Reactor
Designs,’’ respectively, the Commission
approved NRC staff recommendations
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for selected preventative and mitigative
design features for future light-water
reactor designs. Paragraph (a)(23)
requires the applicant to provide a
description and analysis of those design
features discussed in SECY–90–16 and
SECY–93–087. Postulated severe
accidents are not design-basis accidents
(DBAs) and the severe accident design
features do not have to meet the
requirements for DBAs. However, the
severe accident design features are part
of a plant’s design bases information.
Paragraph (a)(24) requires the
applicant to provide a conceptual
design for those design features that are
outside the scope of the certified design,
e.g., service water intake structure or
ultimate heat sink.
Paragraph (a)(25) requires the
applicant to describe the interface
requirements for those design features
that are outside the scope of the
certified design, e.g., service water
intake structure or ultimate heat sink.
Paragraph (a)(26) requires justification
that the interface requirements can be
verified with the ITAAC for the plant.
Paragraph (a)(27) requires the
applicant to provide a description of the
design-specific PRA and its results.
Guidance on how to meet the PRA
information requirement will be
provided in separate regulatory
guidance documents.
Paragraph (b)(1) requires the applicant
to provide the ITAAC that are necessary
and sufficient to demonstrate that a
facility that references the design
certification has been constructed and
will be operated in conformity with the
design certification, the Atomic Energy
Act of 1954, as amended, and the
Commission’s rules and regulations.
These ITAAC will be a part of the
Commission’s verification program and
must cover all of the design information
that is within the scope of the certified
design. ITAAC for the remaining design
features that are outside of the scope of
the certified design will be provided in
a combined license application that
references the design certification rule.
In its SRM on SECY–91–229, ‘‘Severe
Accident Mitigation Design Alternatives
for Certified Standard Designs,’’ dated
October 25, 1991, the Commission
approved the staff’s recommendation
that design certification applicants
assess SAMDAs for their standard plant
designs. The Commission required
SAMDA evaluations in order to achieve
greater finality for the design features
that are resolved in design certification
rulemakings. For further explanation,
see discussion in SECY–93–087, dated
April 2, 1993. In order to implement
this requirement, paragraph (b)(2)
requires the applicant to provide a
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SAMDA evaluation for the standard
plant design. This assessment is distinct
from, and in addition to, the
requirement in paragraph (a)(23) to
provide a description and analysis of
severe accident design features.
Paragraph (c)(1) requires an
essentially complete scope of design in
applications for evolutionary nuclear
power plants. These plants are
improved versions of light-water reactor
designs that were in operation when
part 52 was originally codified.
Examples of evolutionary designs
include General Electric’s U.S.
Advanced Boiling Water Reactor and
Westinghouse’s SP/90 and System 80+
designs. Evolutionary designs do not
have to meet the design qualification
testing requirements set forth in 10 CFR
50.43(e).
Paragraph (c)(2) requires applications
for ‘‘advanced’’ nuclear power plants to
provide an essentially complete scope of
design and meet the design qualification
testing requirements in 10 CFR 50.43(e).
Advanced designs differ significantly
from evolutionary light-water reactor
designs or incorporate, to a greater
extent than evolutionary designs do,
simplified, inherent, passive, or other
innovative means to accomplish their
safety functions. Examples of advanced
nuclear power plant designs include
General Atomic’s Modular High
Temperature Gas-Cooled Reactor,
General Electric’s Simplified Boiling
Water Reactor, and Westinghouse’s
AP600.
Paragraph (c)(3) requires applications
for modular nuclear power plant
designs to describe and analyze the
possible operating configurations of
reactor modules. Modular designs are
defined in § 52.1. Modular plant designs
are not portions of a single nuclear
plant, rather they are separate nuclear
power reactors with some shared or
common systems.
Section 52.48 Standards for Review of
Applications
This section sets forth the parts of 10
CFR that contain applicable
requirements for the technical review of
design certification applications. The
applicability of these requirements to
the design certification process is
specified in the identified parts. The
Commission recognizes that new
designs may incorporate design features
that are not addressed by the current
standards set out in 10 CFR parts 20, 50
and its appendices, 51, 73, or 100, and
that new standards may be required to
address these new design features. The
Commission will determine whether
additional rulemakings are needed or
appropriate to resolve generic safety
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issues that are applicable to multiple
designs. On the other hand, new design
features that are unique to a particular
design could be addressed in the design
certification rulemaking for that
particular design.
Section 52.51 Administrative Review
of Applications
This section sets forth the procedures
for performing a notice and comment
rulemaking for design certification.
Paragraph (b) states that the
Commission will determine, at its sole
discretion, whether to hold a legislative
hearing on the proposed design
certification rule under the procedures
in subpart O of 10 CFR part 2. Paragraph
(c) states that proprietary information
contained in an application for design
certification will be given the same
treatment that such information would
be given in a proceeding on an
application for a construction permit or
an operating license under 10 CFR part
50. This gives the design certification
applicant (vendor) an opportunity to
treat elements of its design as trade
secrets.
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Section 52.53 Referral to the Advisory
Committee on Reactor Safeguards
(ACRS)
This section states that the
application for design certification shall
be sent to the ACRS for its review of
safety issues.
Section 52.54 Issuance of Standard
Design Certification
Paragraph (a) of this section sets forth
the findings that the Commission must
make in order to issue a design
certification rule. Paragraph (b) requires
that site parameters, design
characteristics, and any additional
requirements and restrictions be
specified in the design certification rule.
Previous DCRs set forth the additional
requirements and restrictions in Section
IV of the rule. Site parameters and
design characteristics are defined in
§ 52.1 and can be specified in the design
control document. These values will be
used during the review of a combined
license application that references the
design certification rule to verify that
the standard plant design conforms with
the characteristics of the actual site and
the design parameters used in the early
site permit.
Section 52.54 was amended to
include a new paragraph (c) which
requires that every DCR contain a
provision stating that, after the
Commission has adopted the final DCR,
the applicant for that design
certification will not permit any
individual to have access to, or any
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facility to possess, Restricted Data or
classified National Security Information
until the individual and/or facility has
been approved for access under the
provisions of 10 CFR parts 25 and/or 95.
The NRC believes that this amendment,
along with the changes to parts 25, 95,
and § 50.37, are necessary to ensure that
access to classified information is
adequately controlled by all entities
applying for NRC certifications.
Section 52.55
Duration of Certification
The purpose of this section is to
specify the duration that a standard
design certification is valid for
referencing in a combined license
application.
Section 52.57
Application for Renewal
The purpose of this section is to set
forth the process for applying for
renewal of an existing design
certification rule. Paragraph (a) specifies
the time period for submitting an
application for renewal and states that
any person can apply for renewal.
However, if the applicant for renewal is
not the same person or entity that
applied for the existing design
certification, as identified in Section I of
the DCR, then the new applicant is
required to demonstrate that they have
the capability to provide the detailed
design for that certified nuclear power
plant under § 52.63(c) or § 52.73(b).
Section 52.59
Criteria for Renewal
The purpose of this section is to
identify the regulations that will be used
to determine if an existing design
certification should be renewed.
Paragraph (a) states that the Commission
will grant a request for renewal if the
design complies with the regulations in
effect at the time the certification was
originally issued (see Section V of an
existing design certification rule) and
imposition of any new safety
requirements on the design during a
renewal proceeding will be governed by
the backfit standards in paragraph (b).
Under paragraph (c), the applicant for
renewal may request an amendment to
the existing certified design to make
some design changes provided that the
new design meets the regulations in
effect at the time that the amended,
renewed design certification rule is
issued and the changes do not require
a major review or reanalysis of the new
design. If the changes to the original
design certification are so extensive that
the NRC concludes an essentially new
standard design is being proposed, then
the applicant must submit an
application for a new design
certification under § 52.45.
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Under paragraph (d), denial by the
NRC of a request for renewal of a design
certification does not prevent an
applicant from submitting a new
application for certification under
§ 52.45.
Section 52.61 Duration of Renewal
This section specifies the duration
that a renewed design certification is
valid for referencing in a combined
license application.
Section 52.63 Finality of Standard
Design Certifications
The purpose of this section is to set
forth the process for amending or
backfitting existing design certification
rules (DCRs) or issuing orders to nuclear
plants that referenced a DCR. This
section also describes the finality of
issue resolution under a design
certification and the process for plantspecific departures from a certified
design. This amendment process places
a nuclear plant designer on the same
footing as the Commission or any other
member of the public (see 54 FR 15377,
first column, April 18, 1989). Therefore,
it cannot be said that this section makes
it easier for a designer to amend design
certification information than for the
NRC to backfit the certified design. The
amendment and backfitting process uses
the phrase ‘‘certification information’’ in
order to distinguish the rule language in
the DCRs from the design certification
information (e.g., Tier 1 and Tier 2) that
is incorporated by reference in the
DCRs.
No matter who proposes it, a generic
change under § 52.63(a)(1) will not be
made to a DCR while it is in effect
unless the change: (1) is necessary for
compliance with Commission
regulations applicable and in effect at
the time the certification was issued; (2)
is necessary to provide adequate
protection of the public health and
safety or common defense and security;
(3) reduces unnecessary regulatory
burden and maintains protection to
public health and safety and common
defense and security; (4) provides the
detailed design information necessary to
resolve selected design acceptance
criteria; (5) corrects material errors in
the certification information; (6)
substantially increases overall safety,
reliability, or security of a facility and
the costs of the change are justified; or
(7) contributes to increased
standardization of the certification
information.
Paragraphs (a)(1)(i) and (a)(1)(ii) did
not change in the final rule. Paragraph
(a)(1)(i) provides the compliance
exception to the NRC’s backfit process.
Paragraph (a)(1)(ii) sets forth the special
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backfit criteria, which uses the adequate
protection standard rather than the
backfit standard in 10 CFR 50.109. The
remaining paragraphs permit
amendments of design certification
information without meeting the special
backfit requirement in § 52.63(a)(1)(ii).
Paragraph (a)(1)(iii) allows the
Commission to change the design
certification rule language to reduce
unnecessary regulatory burdens, i.e.,
incorporate the revised § 50.59 change
criteria, or change the certification
information if the change provides a
reduction in regulatory burden and
maintains protection to public health
and safety and common defense and
security. Maintaining protection
generally embodies the same safety
principles used by the NRC in applying
risk-informed decision-making, i.e.,
ensuring that adequate protection is
provided, applicable regulations are
met, sufficient safety margins are
maintained, defense-in-depth is
maintained, and that any changes in risk
are small and consistent with the
Commission’s Safety Goal Policy
Statement (refer to NRC’s RG 1.174).
Paragraph (a)(1)(iv) allows for generic
resolutions of design acceptance criteria
(DAC) by amending DCRs. The DAC are
a special type of ITAAC that are used to
verify the resolution of design issues
where sufficient design information was
not provided in the design certification
application. By generically resolving
DAC with the amendment process, the
Commission achieves resolution of
additional design issues, achieves
finality for those issue resolutions, and
avoids repetitive consideration of those
design issues in individual combined
license proceedings. Also, the
amendments will enhance
standardization by further completing
the certification information. The NRC
staff will review the amendment
application to ensure that the DAC are
met and that the new design
information conforms with the
applicable regulations.
Paragraph (a)(1)(v) allows for generic
resolutions of material errors in the
certification information. This provision
is only to be used to correct a material
error, which is an error that significantly
and adversely affects a design function
or analysis conclusion described in the
design control document (certification
information). The Commission wants to
correct material errors so that these
errors will not have to be addressed in
individual licensing proceedings.
Paragraph (a)(1)(vi) allows for generic
amendments of certification information
that will substantially increase the
overall safety, reliability, or security of
facility design, construction, or
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operation provided that the direct and
indirect costs of implementation of the
amendment are justified in view of this
increased safety, reliability, or security.
This amendment process will function
similar to the backfitting process in 10
CFR 50.109.
Finally, paragraph (a)(1)(vii) allows
for generic amendments that would
increase the standardization of
certification information in referencing
applications. The Commission is still
committed to achieving and maintaining
the benefits of standardization.
Therefore, the final rule allows for
generic amendments of certification
information through this additional
process, provided that the amendment
is applied to all plants that reference the
DCR. This paragraph will allow
applicants and licensees to request
corrections or changes to certification
information through a generic process
rather than through individual licensing
actions. In determining whether to
codify a proposed amendment under
this paragraph, the Commission will
give special consideration to comments
from applicants or licensees who
referenced the DCR regarding whether
they want to backfit their plants with
these additional changes.
The process for amending DCRs will
be a rulemaking with opportunity for
public comment under paragraph (a)(2).
As part of the rulemaking under
§ 52.63(a)(1), except for § 52.63(a)(1)(ii),
the Commission will give consideration
to whether the benefits justify the costs
for plants that are already licensed or for
which an application for a permit or
license is under consideration. The
duration of the amended DCR will be for
the same period of time as the original
DCR and have the same expiration date.
Once a DCR is amended by
rulemaking, under paragraph (a)(3) the
changes will apply to all future
applications referencing the DCR as well
as all current plants referencing the
design certification, unless the change
has been rendered ‘‘technically
irrelevant’’ through other action taken
under paragraphs (a)(4) or (b)(1) of this
section. Thus, standardization is
maintained by ensuring that any
amendment to a DCR is imposed upon
all nuclear power plants referencing the
design certification rule.
Paragraph (a)(4) sets forth the criteria
that must be met before the Commission
can impose new requirements by plantspecific order on a nuclear plant that
references a DCR. Under this paragraph,
the Commission must meet either the
compliance or adequate protection
backfit criteria and cite one or more
special circumstances as defined in
§ 52.7. In addition, the Commission
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49445
shall consider whether the special
circumstances that justify the plantspecific order outweigh any decrease in
safety that may result from the
reduction in standardization caused by
the plant-specific order. This additional
requirement was added to ensure that
the benefits of standardization will be
preserved.
Paragraph (a)(5) sets forth the finality
of matters that are resolved as part of a
design certification rulemaking. Each of
the DCRs have detailed provisions on
the issues that were resolved for that
plant design and detailed processes for
changes to and departures from
certification information (refer to
Sections VI and VIII of appendices A, B,
C, or D to part 52).
Paragraphs (b)(1) and (b)(2) provide
processes for requesting exemptions and
departures from certification
information. As part of its adoption of
a two-tiered rule structure (refer to SRM
on SECY–90–377, dated February 15,
1991), the Commission codified detailed
processes for changes to and departures
from certification information in each of
the design certification rules (refer to
Section VIII of appendices A, B, C, or D
to part 52). The processes for a specific
certified design must be used when
requesting exemptions and departures
from certification information.
Paragraph (c) identifies the detailed
design information that an applicant for
a combined license must have
completed and available for audit by the
NRC. The NRC expects that design
certification applicants (vendors) will
have this information available during
the review of a combined license
application that references the certified
design. Because a rule certifying a
standard plant design does not belong to
the designer (vendor), an applicant for
a combined license that references the
DCR could use a vendor other than the
applicant that achieved the design
certification. In that situation, the
combined license applicant must
acquire the detailed design information
identified in paragraph (c) in order to
demonstrate that the new vendor has
the ability to provide the certified
design and that the combined license
applicant’s design information is
consistent with the design information
for the DCR.
Subpart C—Combined Licenses
Section 52.71 Scope of Subpart
This section describes the scope of the
requirements in this subpart. Under this
subpart an applicant can request a
combined construction permit and
operating license with conditions
(combined license) for a nuclear power
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facility. The combined license is
essentially a combination of a
construction permit, which requires
consideration and resolution of many of
the issues currently considered at the
operating license stage, and a
conditional operating license. Operation
is allowed only after the Commission
has made the finding that all acceptance
criteria in ITAAC have been met.
The combined license application
could describe a site and a custom
design, or it could reference an early site
permit (subpart A of part 52), a standard
design certification (subpart B of part
52), a standard design approval (subpart
E of part 52), or a reactor manufactured
under a manufacturing licenses (subpart
F of part 52) or a combination thereof.
Although a pre-approved site and
certified standard design need not be
referenced for the combined license,
maximum efficiency will result if siterelated issues, as well as design-related
issues, have been resolved before
commencement of the combined license
proceeding.
Section 52.73
Subparts
Relationship to Other
The purpose of this section is to
explain the relationship of the
combined license process to the
licensing processes in subparts A, B, E,
and F of 10 CFR part 52.
Section 52.75
Filing of Applications
This section explains who can file,
how to file, and the fees for NRC review
of an application for a combined
license.
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Section 52.77 Contents of
Applications; General Information
This section sets forth the type of
general information that is required to
be included in an combined license
application, namely, the information
required by 10 CFR 50.33. Section 50.33
requires that the application include
information such as the name and
address of the applicant, a description
of the business or occupation of the
applicant, citizenship information of the
applicant, the class of license applied
for, the use to which the facility will be
put, the time for which the license is
sought, financial qualification
information, State and local emergency
response plans, the earliest and latest
dates for the completion of construction,
and information about decommissioning
funding. Section 50.33 also provides
requirements for the handling of
Restricted Data or other defense
information in an application.
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Section 52.79 Contents of
Applications; Technical Information in
Final Safety Analysis Report
The purpose of this section is to
identify specific technical information
to be included in the final safety
analysis report as part of an application
for a combined license. This generally
includes the same information required
of applicants for construction permits
and operating licenses under 10 CFR
part 50.
This section specifies the complete set
of FSAR information needed for a
combined license that is a stand-alone
application, but also takes into account
that certain information may already
have been submitted and reviewed in
those instances where the application
references an early site permit (subpart
A), a certified design (subpart B), a
standard design approval (subpart E), a
manufacturing license (subpart F), or
some combination. The required FSAR
information also includes requirements
for descriptions of operational programs
that need to be included in the FSAR to
allow a reasonable assurance finding of
acceptability. These additional
requirements are in support of the
Commission’s direction to the staff in
SRM–SECY–02–0067 dated September
11, 2002, ‘‘Inspections, Tests, Analyses,
and Acceptance Criteria for Operational
Programs (Programmatic ITAAC),’’ that
a combined license applicant was not
required to have ITAAC for operational
programs if the applicant fully
described the operational program and
its implementation in the combined
license application. In this SRM, the
Commission stated:
[a]n ITAAC for a program should not be
necessary if the program and its
implementation are fully described in the
application and found to be acceptable by the
NRC at the COL stage. The burden is on the
applicant to provide the necessary and
sufficient programmatic information for
approval of the COL without ITAAC.
The Commission clarified its
definition of fully described in SRM–
SECY–04–0032, ‘‘Programmatic
Information Needed for Approval of a
Combined License Application Without
Inspections, Tests, Analyses, and
Acceptance Criteria,’’ dated May 14,
2004, as follows:
In this context, fully described should be
understood to mean that the program is
clearly and sufficiently described in terms of
the scope and level of detail to allow a
reasonable assurance finding of acceptability.
Required programs should always be
described at a functional level and at an
increased level of detail where
implementation choices could materially and
negatively affect the program effectiveness
and acceptability.
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Accordingly, this section contains
requirements for descriptions of
operational programs and their
implementation.
Paragraph (b) describes the
information that is needed if the
application references an early site
permit. Although a combined license
applicant referencing a certified design
need not resubmit information or
analyses submitted in connection with
the early site permit, the combined
license application FSARs must either
include or incorporate by reference the
SSAR for the early site permit. The
SSAR must be included or incorporated
into the combined license FSAR to
ensure that matters addressed in the
SSAR legally become part of the FSAR
upon issuance of the combined license.
This will also ensure that the
information in the SSAR is subject to
control under § 50.59 after issuance of
the combined license. This provision is
meant to convey that the combined
license applicant referencing the early
site permit does not need to resubmit,
for NRC review, information or analyses
that were already reviewed and resolved
in the early site permit proceeding (such
as information provided in responses to
NRC requests for additional
information). At the same time, this
provision provides combined license
applicants guidance as to what the
combined license application must
contain to be considered complete,
including a requirement that it contain
or incorporate the early site permit
SSAR.
Because an early site permit applicant
need not specify a particular nuclear
plant design, the combined license
application must demonstrate that the
design of the facility falls within the site
characteristics and postulated design
parameters specified in the early site
permit. If the application does not
demonstrate that design of the facility
falls within the site characteristics and
design parameters of the early site
permit, then, the applicant must request
for a variance from the early site permit.
Paragraph (b) requires that the
application demonstrate that all terms
and conditions in the early site permit,
excluding terms and conditions
imposed under § 50.36b, be satisfied by
the date of issuance of the combined
license. Any terms or conditions of the
early site permit that could not be met
by the time of issuance of the combined
license must be set forth as terms or
conditions of the combined license.
Early site permit conditions imposed
under § 50.36b are to be addressed in
the environmental report and not in the
FSAR.
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Paragraph (b) also addresses
emergency planning information
submitted in a referenced early site
permit and requires that the combined
license application include any new or
additional information to update or
correct information provided with the
early site permit and to discuss whether
the new information may materially
change the bases for compliance with
the applicable NRC requirements. New
information which materially changes
the bases for compliance includes: (1)
information which substantially alters
the bases for a previous NRC conclusion
with respect to the acceptability of a
material aspect of emergency
preparedness or an emergency
preparedness plan, as well as (2)
information which would constitute a
sufficient basis for the Commission to
modify or impose new terms and
conditions related to emergency
preparedness in accordance with
§ 52.39(a)(1). New information that
substantially alters the bases for a
previous NRC conclusion or constitutes
a sufficient basis for Commission to
modify or impose new terms and
conditions related to emergency
preparedness would be subject to
litigation during the combined license
proceeding in accordance with
§ 52.39(c). This paragraph also
addresses referenced early site permit
emergency plans that incorporate
existing emergency plans and requires
the combined license application to
identify changes to the emergency plans
that constitute a decrease in
effectiveness under 10 CFR 50.54(q).
This requirement ensures that the NRC
can review such changes to assess their
impact on the emergency plans for the
proposed combined license facility.
Paragraph (c) and (d) provide
application requirements for a
combined license that is referencing a
standard design approval or a standard
design certification, respectively.
Similar to a combined license
application referencing an early site
permit, a combined license application
referencing a design approval or design
certification must either include or
incorporate by reference the design
approval or design certification FSAR.
Because a design approval or design
certification applicant need not specify
a particular site, the combined license
application must demonstrate that
characteristics of the site fall within the
site parameters specified in the design
approval or design certification. In
addition, the plant-specific PRA
information must use the PRA
information for the design certification
and must be updated to account for site-
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specific design information and any
design changes or departures. An
applicant referencing a design
certification must demonstrate that the
interface requirements established for
the design have been met. Applicants
referencing either a design approval or
a design certification must demonstrate
that any terms and conditions in the
design approval or requirements and
restrictions in the referenced design
certification rule will be satisfied by the
date that the combined license is issued.
Any terms or conditions of the design
approval that cannot be met or satisfied
by the time of issuance of the combined
license must be set forth as terms or
conditions of the combined license.
Likewise, any requirements or
restrictions of the design certification
that cannot be met or satisfied by the
time of issuance of the combined license
must be set forth as terms or conditions
of the combined license.
Paragraph (e) describes the
information that is needed if the
combined license application references
one or more manufactured reactors.
Similar to a combined license
application referencing an early site
permit, design approval, or design
certification, a combined license
application referencing one or more
manufactured nuclear power reactors
under subpart F or part 52 must either
include or incorporate by reference the
manufacturing license FSAR. Because a
manufacturing license applicant need
not specify a particular site for the
installation of a manufactured reactor,
the combined license application must
demonstrate that the site parameters for
the manufactured reactor are bounded
by the site where the manufactured
reactor is to be installed and used. In
addition, the plant-specific PRA
information must use the PRA
information for the manufactured
reactor and must be updated to account
for site-specific design information and
any design changes or departures. The
combined license application must also
demonstrate that the interface
requirements established for the design
have been met and that any terms and
conditions in the manufacturing license
will be satisfied by the date that the
combined license is issued. Any terms
or conditions of the manufacturing
license that could not be met by the
time of issuance of the combined license
must be set forth as terms or conditions
of the combined license.
Section 52.80 Contents of
Applications; Additional Technical
Information
This section covers the required
technical contents of a combined license
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application that are not contained in the
FSAR. These application contents
include the proposed ITAAC, the
environmental report, and information
to address an applicant’s request to
perform activities at the site allowed by
10 CFR 50.10(e) before issuance of the
combined license.
Paragraph (a) requires the application
to include the proposed ITAAC and, if
the application references an early site
permit with ITAAC or a design
certification, requires the applicant to
use the ITAAC contained in the early
site permit or design certification for the
applicable portion of the combined
license application. ITAAC that must be
included are those that are necessary
and sufficient to demonstrate that the
facility has been constructed and will be
operated in conformity with the
combined license, the provisions of the
Atomic Energy Act of 1954 and the
Commission’s rules and regulations. In
addition, under Section 52.103(g), the
Commission must find that all
acceptance criteria specified in the
license are met before facility operation.
Because ITAAC are the sole source of
acceptance criteria for subsequent
resolution of items which cannot be
fully evaluated prior to issuance of a
combined license, it is essential that the
combined license ITAAC include all
significant issues that require
satisfactory resolution before fuel
loading.
This paragraph also provides an
applicant for a combined license with a
process for resolving certain acceptance
criteria in one or more of the ITAAC
before issuance of the combined license.
This provision is included mainly to
allow for completion of DAC at the
combined license application stage
because applicants might want to
complete certain DAC before
construction. DAC are special design
certification rule ITAAC. DAC set forth
processes and criteria for completing
certain design information, such as
information about the digital
instrumentation and control system.
Many DAC were originally written to be
verified as part of the normal, postcombined license, ITAAC verification
process. Completion of the design
matters covered by DAC before the
issuance of a combined license is
consistent with the Commission’s
original concept for design certification
and issuance of a combined license.
When it adopted 10 CFR part 52, the
Commission intended that a design
certification contain final and complete
design information. Allowing a finding
of acceptable completion of DAC before
issuance of a combined license is,
therefore, consistent with the
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Commission’s original intent. Second,
completion of DAC before issuance of
the combined license is consistent with
the Commission’s goal of resolving
issues before construction. Determining
whether DAC have been successfully
completed before issuance of the
combined license avoids the possibility
that improperly completed DAC will
result in the construction of improperly
designed structures, systems, and
components. Accordingly, a finding of
successful completion of DAC may be
made when a combined license is
issued, if the combined license
applicant demonstrates that the DAC
have been successfully completed. This
process would also allow findings on
successful completion of inspections or
tests of components procured before the
issuance of the combined license.
Paragraph (b) requires a complete
environmental report in accordance
with 10 CFR 51.50(c).
Paragraph (c) requires that, if the
applicant is requesting to perform any
activities at the site allowed by 10 CFR
50.10(e), then the applicant must
identify and describe the activities and
propose a plan for redress of the site in
the event that the activities are
performed and either construction is
abandoned or the combined license is
revoked. This paragraph also requires
the applicant to demonstrate that there
is reasonable assurance that redress
carried out under the plan will achieve
an environmentally stable and
aesthetically acceptable site suitable for
whatever non-nuclear use may conform
with local zoning laws. These
requirements attempt to limit, to the
extent practicable, the environmental
impact of any site work done in the case
where construction of the nuclear power
facility is not completed.
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Section 52.81 Standards for Review of
Applications
This section identifies the regulations
that the NRC staff will use in performing
its review of an application for a
combined license.
Section 52.83 Finality of Referenced
NRC Approvals; Partial Initial Decision
of Site Suitability
This section describes the finality of
regulatory products that may be
referenced in a combined license
application. Specifically, paragraph (a)
states that the finality of matters
resolved in a referenced early site
permit, design certification, design
approval, or manufacturing license are
governed by the finality provisions in
the respective subparts that address
each of these regulatory processes.
Paragraph (b) states that, while a partial
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decision on site suitability is in effect
under 10 CFR 2.617(b)(2), the finality
provisions in 10 CFR 2.629 govern the
scope and nature of matters resolved in
the proceeding.
Section 52.85 Administrative Review
of Applications; Hearings
This section identifies the procedural
requirements that apply to the
mandatory combined license hearing.
This section also identifies that, if an
applicant requests a Commission
finding on certain ITAAC with the
issuance of the combined license, then
those ITAAC will be identified in the
notice of hearing.
Section 52.87 Referral to the Advisory
Committee on Reactor Safeguards
(ACRS)
This section states that the ACRS will
report on those portions of the
application which concern safety.
Section 52.91 Authorization To
Conduct Site Activities
The purpose of this section is to
outline the activities that can be
performed at the site by a combined
license applicant. Paragraph (a) of this
section discusses the authorization a
combined license applicant needs to
obtain in order to perform limited work
activities at the site while the NRC is
considering the combined license
application in the case where a
combined license applicant does not
reference an early site permit that
contains a redress plan. The
requirements contained in paragraph (a)
discuss work commonly referred to as a
limited work authorization 1 (LWA–1)
that is allowed in accordance with the
requirements contained in 10 CFR
50.10(e)(1). These requirements do not
allow the applicant to perform LWA–1
activities without first submitting a
redress plan and obtaining the separate
authorization required by 10 CFR
50.10(e)(1). Plans are expected to be
modeled on the Midland Site
Stabilization Report that was submitted
on October 2, 1986 (ML061710504).
Paragraph (a) recognizes this
possibility and notes that authorization
may be granted only after the presiding
officer in the proceeding on the
application has made the findings and
determination required by 10 CFR
50.10(e)(2) and has determined that
redress carried out under the site
redress plan will return the site to an
aesthetically acceptable and
environmentally stable condition.
Paragraph (b) contains requirements
for work commonly referred to as an
LWA–2. An LWA–2 allows structural
work for structures, systems, and
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components which prevent or mitigate
the consequences of postulated
accidents that could cause undue risk to
the health and safety of the public.
Because the design must be known to
obtain authorization for LWA–2
activities, an LWA–2 is an option for a
combined license applicant but not an
option for an early site permit holder. A
combined license applicant may request
LWA–2 authority prior to the combined
license being granted. Paragraph (b)
recognizes this possibility and notes
that authorization may be granted only
after the presiding officer in the
combined license makes the additional
finding required by 10 CFR
50.10(e)(3)(ii), namely, that there are no
unresolved safety issues relating to the
LWA–2 activities.
Paragraph (c) of this section clarifies
that, if work is performed either under
an LWA–1, or LWA–2 or both, and the
combined license application is
subsequently withdrawn by the
applicant or denied by the NRC, then
the combined license applicant must
redress the site in accordance with the
terms of the site redress plan. Paragraph
(c) of this section also provides the
combined license applicant with the
ability to redress the site for an alternate
use that was not considered at the time
that the original redress plan was
prepared.
Section 52.93 Exemptions and
Variances
The purpose of this section is to
describe the process for combined
license applicants to obtain exemptions
and variances. If the request is for an
exemption from any part of a referenced
design certification rule, the
Commission can grant the request only
if it determines that the exemption
complies with any exemption
provisions in the referenced design
certification rule, or with § 52.63 if there
are no applicable exemption provisions
in the referenced design certification
rule. A request for an exemption that is
outside the scope of a design
certification rule must be processed in
accordance with the requirements
contained in § 52.7.
For the General Electric ABWR,
Westinghouse System 80+,
Westinghouse AP600, and
Westinghouse AP1000 designs, these
requirements are contained in Section
VIII, ‘‘Processes for Changes and
Departures,’’ of appendices A, B, C, and
D respectively, of 10 CFR part 52.
Section VIII of these appendices
discusses the process for exemptions
from different portions of the design
certification rule. The section-by-section
analysis for these respective rules
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discuss requirements regarding
processing of exemptions that are
expected to be carried forward to future
design certification rulemakings.
Therefore, if applicable, the applicant
should refer to the respective sectionby-section analysis in the portion of the
design certification rule that discusses
exemptions for additional information.
Exemptions requested in accordance
with this section are subject to litigation
in the same manner as other issues in
the licensee hearing.
Paragraph (b) of this section sets forth
the process for requesting variances
from an early site permit if one is
referenced in the combined license.
Paragraph (c) sets forth the process for
requesting variances from one or more
design characteristics, site parameters,
terms and conditions, or approved
design of a manufactured reactor.
Issuance of a variance is subject to
litigation during the combined license
proceeding in the same manner as other
issues material to that proceeding.
Section 52.97 Issuance of Combined
Licenses
The purpose of this section is to set
forth the process for issuing a combined
license. Paragraph (a)(1) of this section
sets forth the requirements relative to
the Commission findings that must be
made for granting of a combined license.
Paragraph (a)(2) of this section allows
for completion of certain acceptance
criteria in one or more of the ITAAC in
a combined license being met prior to
granting of the combined license. This
paragraph could apply to DAC found in
the applicable design certification rules.
DAC set forth processes and criteria for
completing certain design information,
such as information about the digital
instrumentation and control system.
Paragraph (a)(2) would allow the
Commission to make a finding of
successful completion of DAC when a
combined license is issued, if the
combined license applicant
demonstrates that the DAC have been
successfully completed. This process
would also allow findings on successful
completion of inspections or tests of
components procured before the
issuance of a combined license.
Paragraph (a)(2) notes that such a
finding will preclude any required
finding under § 52.103(g) with respect to
that ITAAC.
Paragraph (b) requires the
Commission to identify the ITAAC
within the combined license that the
licensee shall perform, and the
acceptance criteria that, if met, are
necessary and sufficient to provide
reasonable assurance that the facility
has been constructed and will be
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operated in conformity with the license,
the provisions of the Act, and the
Commission’s rules and regulations.
This definition of what ITAAC are
intended to accomplish is consistent
with that contained in § 52.17 regarding
early site permits, § 52.47 regarding
design certifications and § 52.80, which
are discussed above. If the combined
license application references an early
site permit with ITAAC related to
emergency planning information, then
the applicant must use these ITAAC in
the emergency planning information
submitted with the combined license
application. If a combined license
applicant references a design
certification rule, the ITAAC contained
in the license would be those contained
in the design certification rule plus any
additional ITAAC that were identified
during the combined license review that
were outside the scope of the certified
design. If the Commission wishes to
identify additional ITAAC that fall
within the scope of the review of the
referenced certified design it needs to
meet the requirements contained in the
design certification rule itself (see
Section VIII.A.3 of appendix A, B, C,
and D for the ABWR, System 80+,
AP600, and AP1000) and the
requirements contained in § 52.63. If a
combined license applicant does not
reference an early site permit or a
certified design, then the ITAAC that are
identified by the Commission for
paragraph (b) of this section are those
that were identified during the
combined license review.
Section 52.98 Finality of Combined
Licenses; Information Requests
This section covers the finality of
combined license provisions and sets
forth the requirements to modify the
combined license after it has been
issued. After issuance of a combined
license, the Commission may not
modify, add, or delete any term or
condition of the combined license, the
design of the facility, the inspections,
tests, analyses, and acceptance criteria
contained in the license which are not
derived from a referenced standard
design certification or manufacturing
license, except in accordance with the
backfit provisions of §§ 52.103 or
50.109, as applicable.
Paragraphs (b), (c), and (d) outline the
applicability of the change processes in
10 CFR part 50, Section VIII of the
design certification rules, and subpart F
of 10 CFR part 52 to a combined license.
The change processes in 10 CFR part 50
apply to a combined license that does
not reference a design certification rule
or a reactor manufactured under a
manufacturing license. Section 52.98(c)
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49449
states that the change processes in
Section VIII of the design certification
rules apply to changes within the scope
of the referenced certified design.
However, if the proposed change affects
the design information that is outside of
the scope of the design certification
rule, the part 50 change processes apply
unless the change also affects the design
certification information. For that
situation, both change processes may
apply. If the combined license
references a reactor manufactured under
a subpart F manufacturing license, then
changes to or variances from
information within the scope of the
manufactured reactor’s design are
subject to the change processes in
§ 52.171.
Paragraph (e) was added in 1992, and
discussed in the section-by-section
analysis (57 FR 60976; December 23,
1992), as following:
This section has been amended with regard
to making amendments to a combined license
immediately effective under the so-called
‘‘Sholly Amendment.’’ Under the Energy
Policy Act, an amendment to a combined
license can be made immediately effective if
the Commission determines there are no
significant hazards considerations. This
section of the rule has been revised to
incorporate the statutory provisions and
previously issued Commission regulations
implementing the ‘‘Sholly’’ amendment. The
Commission, however, stresses that it will
not look with favor upon license
amendments to a combined license filed
shortly before planned operation that could
have the effect of undermining
standardization or changing the scope of
imminent or pending hearings on
conformance issues.
Paragraph (f) states that any
modification to a combined license is an
amendment to the license and that there
must be an opportunity for hearing on
these amendments. Such amendments
would be processed in accordance with
the requirements contained in 10 CFR
50.90 and 50.91. In addition, if the
applicant has referenced a certified
design, or a reactor manufactured under
a manufacturing license, additional
requirements may apply. For example, a
combined license that references an
ABWR certified design may request an
exemption from Tier 1 material in
accordance with the provisions
contained in Section VIII.A.4 of
appendix A of 10 CFR part 52. In such
a case, the licensee would have to
process an exemption in accordance
with the requirements contained in
appendix A to part 52 and 10 CFR
52.63(b)(1) and a license amendment in
accordance with paragraph (f) of this
section.
Paragraph (g) which is analogous to
§§ 52.39(f), 52.145(c), and 52.171(c),
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provides that NRC information requests
must be evaluated before issuance to
ensure that the burden to be imposed by
the information request is justified in
view of the potential safety significance
of the issue to be addressed, except
when the information requests seeks to
verify compliance with the current
licensing basis of the combined license.
Information requests may be in the form
of a new rule requiring submission of
information (i.e., a new information
collection and reporting requirement),
or in the form of a NRC staff request for
information. Information requests by the
staff must be in accordance with 10 CFR
50.54(f) and must be approved by the
EDO or his or her designee before the
request may be issued.
Section 52.99 Inspection During
Construction
The purpose of this section is to set
forth the requirements to support the
NRC’s inspections during construction.
A new § 52.99(a) has been added to
require 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 in 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 § 52.99(c). The information
provided by the licensee will be used by
NRC in developing the NRC’s inspection
activities and activities necessary to
support the Commission’s finding
whether all of the ITAAC have been 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 expect the licensee to notify the
NRC that there have been no changes to
the schedule.
Section 52.99 has also been amended
to incorporate rule language from the
design certification rules in 10 CFR part
52 regarding the completion of ITAAC
(see paragraphs IX.A and IX.B.3 of
appendix A to part 52). During the
preparation of the design certification
rules for the ABWR and System 80+
designs, the NRC staff and nuclear
industry representatives agreed on
certain requirements for the
performance and completion of the
inspections, tests, or analyses in ITAAC.
In the design certification rulemakings,
the Commission codified these ITAAC
requirements into Section IX of the
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regulations. The purpose of the
requirement in § 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 has been met.
Section 52.99(c)(1) requires the
licensee to notify the NRC that the
prescribed inspections, tests, and
analyses have been performed and that
the prescribed acceptance criteria have
been met. Section 52.99(c)(1) further
requires that the notification contain
sufficient information to demonstrate
that the prescribed inspections, tests,
and analyses have been performed and
that the prescribed acceptance criteria
have been met.
Section 52.99(c)(2) requires 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 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
determination as to whether all of the
ITAAC have been or will be 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 has been completed and the
acceptance criteria met. The NRC
expects the notification to be
sufficiently complete and detailed for a
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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 have been 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 have been
performed and that the prescribed
acceptance criteria have been 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
expects the information that the licensee
submits under paragraph (c)(2) to be
sufficiently detailed such that the NRC
can determine what activities it will
need to undertake to determine if the
acceptance criteria for each of the
uncompleted ITAAC have been 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 have been 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 § 52.103(g).
Therefore, licensees should structure
their construction schedules to take into
account these time periods.
A new 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
have not been 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 has been met, the
licensee may take corrective actions to
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successfully complete that ITAAC or
request an exemption from the standard
design certification ITAAC, as
applicable. A request for an exemption
must also be accompanied by a request
for a license amendment under
§ 52.98(f). Also, if an activity that is
subject to an ITAAC is not derived from
a referenced standard design
certification and the licensee has not
demonstrated that the ITAAC has been
met, the licensee may take corrective
actions to successfully complete that
ITAAC or request a license amendment
under § 52.98(f).
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. When part 52
was first adopted by the Commission in
1989 (April 18, 1989; 54 FR 15372), the
rule provided that the NRC staff shall
ensure that the inspections, tests, and
analyses in the ITAAC are performed,
and did not refer to the Commission
finding on acceptance criteria being
met. The Commission revised the
language in this portion of the rule in
1992 (December 23, 1992; 57 FR 60975)
to reflect changes to Section 185 of the
AEA made by Congress in the Energy
Policy Act of 1992 (1992 EPA), which
states:
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Following issuance of the combined
license, the Commission shall ensure that the
prescribed inspections, tests, and analyses
are performed and, prior to operation of the
facility, shall find that the prescribed
acceptance criteria are met.
Thus, the revisions to this portion of
the rule in 1992 simply reflected the
language of the 1992 EPA. However, the
Commission does not believe that
Congress, by adopting language in
Section 185 stating that the Commission
shall ensure that the ITAAC are
performed, intended to prohibit the
Commission’s long-standing practice of
delegating to the NRC staff the
responsibility for performing the
necessary activities, including audits
and inspections, to ensure that ‘‘the
required inspections, tests, and analyses
in the ITAAC are performed.’’
Accordingly, the language from the 1992
rule change is retained in this final rule.
Paragraph (e)(1) requires the NRC to
publish, at appropriate intervals until
the last date for submission of requests
for hearing under § 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
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the licensee notifications under
paragraphs (c)(1) and (c)(2). In general,
the NRC expects to make the paragraph
(c)(1) notifications availability shortly
after the NRC has received the
notifications and concluded that they
are complete and detailed. Furthermore,
by the date of the Federal Register
notice of intended operation and
opportunity to request a hearing on
whether acceptance criteria have been
or will be met (under § 52.103(a)), the
NRC will make available the
notifications under paragraph (c)(2), and
the notifications under paragraph (c)(2)
for all ITAAC for which paragraph (c)(1)
notifications have not been provided by
the licensee.
Section 52.103 Operation Under a
Combined License
The purpose of this section is to set
forth the requirements for operation
under a combined license. This section
has been previously discussed in a
section-by-section analysis for the 1992
revisions to part 52 (57 FR 60976;
December 23, 1992) which the NRC
adopted in response to the Energy
Policy Act of 1992. The 1992 section-bysection analysis states:
In an effort to adhere as closely as possible
to the new statutory requirements of the
Energy Policy Act, the NRC has replaced
most of its old § 52.103 with the text of
section 2802 of that Act. Under the revised
language, any request for a post-construction
hearing must show, prima facie, both that
one or more of the acceptance criteria are not
or will not be met, and those specific
operational consequences of nonconformance
that would be contrary to providing
reasonable assurance that the public health
and safety will be adequately protected. The
Commission may permit interim operation of
a facility pending a hearing if it determines
that this assurance exists. The Commission
has the discretion to decide if any postconstruction hearing will use formal or
informal hearing procedures, and it must
state publicly the reasons for choosing either
set of procedures. The Commission must
find, prior to operation of the facility, that the
acceptance criteria have been met.
Paragraph (a) of this section is revised
to require licensees to notify the NRC of
its schedule date for initial loading of
fuel no later than 270 days before the
scheduled date and to notify the NRC of
updates to its schedule every 30 days
thereafter. This information will be used
by the NRC to develop the notice of
intended operation in the Federal
Register, which must be published not
less than 180 days before the licensee’s
initial fuel load date, as required by
Section 189.a.(1)(B) of the AEA. In
addition, paragraph (a) addresses the
possibility that an applicant for a
combined license may choose to resolve
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49451
certain acceptance criteria in one or
more of the ITAAC required by § 52.80
before issuance of the combined license.
In such a case, if the Commission makes
a finding in accordance with § 52.97
associated with these ITAAC at the time
that a combined license is granted, these
ITAAC would not be subjected to a
hearing opportunity again under
paragraph (a) of this section. The
section-by-section analysis for § 52.97
discusses this issue in more detail.
Paragraph (b) provides the criteria
that must be met for any request for a
hearing on whether the facility complies
or will comply with the acceptance
criteria. The petitioner must set forth
with reasonable specificity the facts and
arguments which form the basis for the
request. These provisions are designed
to accord finality to the Commission’s
earlier decisions regarding the facility
and to ensure that any proceeding is
focused on significant safety issues.
Paragraph (c) requires the
Commission to expeditiously either
deny or grant any request for a hearing
under this section. If a request is
granted, the Commission must
determine whether to allow interim
operation of the facility based on
reasonable assurance of adequate
protection of the public health and
safety.
Paragraph (d) provides that the
Commission will determine the
appropriate hearing procedures in
accordance with 10 CFR part 2 for any
hearing under paragraph (a) of this
section. Under § 2.309, as adopted by
the Commission in 2004 (69 FR 2182;
January 14, 2004), such a hearing would
ordinarily be conducted under subpart L
of part 2. However, the Commission
may direct, in the notice of required by
paragraph (a) or in a subsequent order,
that any hearing that may be conducted
in a particular combined license
proceeding under paragraph (a) use
other, less formal hearing procedures,
consistent with the requirements of the
AEA. Any such Commission direction is
consistent with the Commission’s
statement in the SOC for the 1989 final
part 52 rulemaking (54 FR 15372, 15383;
April 18, 1989) that any hearing held
under former § 52.103(b)(2)(i)
(§ 52.103(b) in this final rule) will use
informal procedures to the maximum
extent practical and permissible under
law.
Paragraph (e) states that the
Commission will, to the maximum
extent possible, render a decision on
issues raised in any hearing request
within 180 days of the publication of
the notice or by the anticipated date for
initial fuel load, whichever is later.
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Paragraph (f) provides requirements
related to the submittal of petitions to
modify the terms and conditions of a
combined license and states that fuel
loading and operation under a
combined license will not be affected by
the granting of a petition unless the
Commission makes an order
immediately effective.
Paragraph (g) prohibits the licensee
from operating the facility until the
Commission makes a finding that the
acceptance criteria in the combined
license are met (except for acceptance
criteria that the Commission found were
met when the combined license was
issued). The NRC believes that the rule
should reflect, as closely as possible, the
statutory requirement in Section 185.b
of the AEA. Although the NRC has
historically viewed ‘‘operation’’ as
including loading of fuel into the
reactor, the NRC believes it is not
necessary to change the language of
§ 52.103(g) to continue the historical
practice.
Paragraph (h) of this section
incorporates rule language from the
design certification rules in 10 CFR part
52 regarding the completion of ITAAC
(see paragraphs IX.A and IX.B.3 of
appendix A to part 52). This paragraph
states that ITAAC do not, by virtue of
their inclusion in the design
certification rule or combined license,
constitute regulatory requirements after
the licensee has received authorization
to load fuel or for any renewal of the
license. However, subsequent
modifications to the facility or
procedures described in the FSAR must
comply with the requirements in
§ 52.98.
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Section 52.104
License
Duration of Combined
This section addresses the duration of
a combined license which is a period
not to exceed 40 years from the date that
the Commission makes the finding that
the acceptance criteria in the license are
met, in accordance with § 52.103(g).
Where the Commission has allowed
operation during an interim period
under § 52.103(c), the period of
operation is not to exceed 40 years from
the date allowing operation during the
interim period. This provision
implements Section 621 of the Energy
Policy Act of 2005 which amended
Section 103c. of the AEA. The AEA
provided that the 40 year duration
started on the date that the Commission
authorized construction of the facility
(i.e., the date of issuance of the
combined license).
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Section 52.105 Transfer of Combined
License
This section states that a combined
license may by transferred in
accordance with 10 CFR 50.80,
‘‘Transfer of licenses.’’ Section 50.80
provides the requirements regarding
application for a license transfer. All
license transfers must be approved by
the Commission.
Section 52.107 Application for
Renewal
This section states that an application
to renew a combined license must be in
accordance with 10 CFR part 54,
‘‘Requirements for Renewal of Operating
Licenses for Nuclear Power Plants.’’
Section 52.109 Continuation of
Combined License
This section, which is analogous to
§ 50.51, provides requirements for a
combined license facility that has
permanently ceased operations and
states that the license continues in effect
beyond the expiration date until the
Commission notifies the licensee in
writing that the license is terminated.
During this period, the licensee is
required to decommission and
decontaminate the facility; maintain the
facility, including the spent fuel, in a
safe condition; and continue to follow
the NRC’s regulations and the
provisions of the combined license.
Section 52.110 Termination of License
This section, which is analogous to
§ 50.82, provides requirements the
termination of a combined license.
These provisions include a requirement
to notify the NRC within 30 days when
a licensee has decided to permanently
cease operations and to submit a
certification to the NRC once fuel has
been permanently removed from the
reactor vessel. This section also requires
decommissioning of the facility within
60 years of permanent cessation of
operations and outlines requirements
regarding decommissioning activities.
Subpart E—Standard Design Approvals
Section 52.131 Scope of Subpart
This section describes the scope of
this process for design approvals of
standard nuclear power plants or major
portions thereof, i.e., a nuclear steam
supply system or balance of plant.
Under this subpart an applicant may
request pre-approval of a standard
nuclear power plant design, separate
from a site review or other licensing
action, and subsequently have that
design approval referenced in an
application to build a nuclear power
plant. This licensing process was first
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adopted by the Commission in 1975 and
has been used many times.
Section 52.133
Subparts
Relationship to Other
The purpose of this section is to
explain the relationship of the standard
design approval process to the processes
set forth in subparts B, C, and F of 10
CFR part 52, which provide for design
certifications, combined licenses, and
manufacturing licenses. The
Commission continues to believe that
the best approach for obtaining early
resolution of design issues is through
the design certification process in
subpart B of this part. Applicants for a
design approval have the option of also
applying for design certification.
Applicants for a combined license or a
manufacturing license may reference a
design approval.
Section 52.135
Filing of Applications
This section explains how to file an
application for a standard design
approval and how the fees for NRC’s
review of the application will be
assessed. Applications are limited to
final design information, in order to
remove the unpredictability of issuing a
construction permit that references only
preliminary design information and
initiating construction while the final
design information is being completed.
Approval of a final standard design
ensures early consideration and
resolution of technical matters by the
NRC staff before there is any substantial
commitment of resources, which will
greatly enhance regulatory stability and
predictability.
Section 52.136 Contents of
Applications; General Information
This section identifies the general
information that must be included in all
applications.
Section 52.137 Contents of
Applications; Technical Information
The purpose of this section is to
identify the technical information that
must be included in an application for
a design approval. Paragraphs (a) and (c)
describe information that must be
included in the FSAR, which is
included in the application, and
paragraph (b) describes the information
that must also be included in the
application but does not need to be
included in the FSAR. Applications for
a major portion of the plant design, such
as the nuclear steam supply system,
only need to contain the technical
information that is applicable to the
major portion of the plant for which
NRC staff approval is requested.
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Many of the requirements in this
section were taken from 10 CFR 50.34
or are pointers to technical requirements
in parts 20, 50, and 73 that must be
addressed in the application. The
requirements taken from § 50.34 are a
subset of the information required of
applicants for construction permits and
operating licenses. Other requirements
came from appendix O to part 50 or
were created by the Commission during
its simultaneous reviews of applications
for design approvals and design
certifications.
Although an applicant for design
approval does not need to specify a
particular site for the nuclear power
plant, which is required in a combined
license application, it does need to
identify the site parameters that the
standard nuclear power plant or major
portion thereof is designed to meet, e.g.,
postulated values for the safe shutdown
earthquake response spectra and
maximum tornado wind speed. These
parameters are usually selected to
envelop a large portion of nuclear plant
sites in the United States. Once the
design is approved by the NRC,
conformance of the actual site
characteristics with the established site
parameters must be demonstrated by an
applicant referencing the design
approval and verified by the NRC staff
at the time that the referencing
application is submitted, i.e., combined
license application.
Paragraph (a)(7) requires the applicant
for design approval to describe its
qualifications to design and analyze a
standard nuclear power plant.
In its staff requirements memorandum
(SRM) on SECY–90–377, ‘‘Requirements
for Design Certification under 10 CFR
part 52,’’ dated February 15, 1991, the
Commission stated that information
submitted in an application should
incorporate the experience from
operating events in current designs
which we want to prevent in the future.
Therefore, for plant designs that are
based on or are evolutions of nuclear
plants that have operated in the United
States, paragraph (a)(22) requires the
applicant to demonstrate how relevant
operating experience insights, from
NRC’s generic letters and bulletins
issued after the most recent revision of
the applicable SRP and 6 months before
the docket date of the application, have
been incorporated into the plant design.
Operating experience includes
consideration of operating events and
the reliability and performance of
structures, systems, and components. If
the application is for a design that is not
based on or is not an evolution of a
nuclear plant that operated in the
United States, the applicant must
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demonstrate how insights from any
relevant international operating
experience have been incorporated into
that plant design.
In its SRMs, dated June 26, 1990, and
July 21, 1993, on SECY–90–16,
‘‘Evolutionary Light-Water Reactor
Certification Issues and their
Relationship to Current Regulatory
Requirements,’’ and SECY–93–087,
‘‘Policy, Technical, and Licensing Issues
Pertaining to Evolutionary and
Advanced Light-Water Reactor
Designs,’’ respectively, the Commission
approved NRC staff recommendations
for selected preventative and mitigative
design features for future light-water
reactor designs. Paragraph (a)(23)
requires the applicant to provide a
description and analysis of those design
features discussed in SECY–90–16 and
SECY–93–87.
Paragraph (a)(U0 ) requires the
application to describe the interfaces for
those design features that are outside
the scope of the approved design, e.g.,
service water intake structure or
ultimate heat sink or, if the application
is for approval of a major portion of the
plant design, the interfaces between the
nuclear steam supply system and the
balance of plant.
Paragraph (a)(25) requires the
applicant to provide a description of the
design-specific PRA and its results.
Guidance on meeting the PRA
information requirements will be
provided in separate regulatory
guidance documents.
Paragraph (b) requires applications for
‘‘advanced’’ nuclear power plants to
meet the design qualification testing
requirements in 10 CFR 50.43(e).
Advanced designs differ significantly
from evolutionary light-water reactor
designs or incorporate, to a greater
extent than evolutionary designs do,
simplified, inherent, passive, or other
innovative means to accomplish their
safety functions. Examples of advanced
nuclear power plant designs include
General Atomic’s Modular High
Temperature Gas-Cooled Reactor,
General Electric’s Simplified Boiling
Water Reactor, and Westinghouse’s
AP600.
Section 52.139 Standards for Review
of Applications
This section sets forth the parts of 10
CFR that contain applicable
requirements for the technical review of
applications for a design approval. The
applicability of these requirements is
specified in the identified parts. The
Commission recognizes that new
designs may incorporate design features
that are not addressed by the current
standards in 10 CFR parts 20, 50 and its
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49453
appendices, 73, or 100 and that new
standards may be required to address
these new design features. The
Commission will determine whether
rulemakings are needed or appropriate
to resolve generic safety issues that are
applicable to multiple designs.
Section 52.141 Referral to the
Advisory Committee on Reactor
Safeguards (ACRS)
This section states that the
application for design approval shall be
sent to the ACRS for its review of safety
issues.
Section 52.143
Design
Staff Approval of
This section states that upon
completion of the NRC staff’s review of
the standard design and receipt of a
letter report from the ACRS, the staff
shall issue a final safety evaluation
report (FSER) and make that report
available on the NRC’s Web site. Also,
if the FSER demonstrates that the
standard design is acceptable, the
Director of the Office of New Reactors
or the Office of Nuclear Reactor
Regulation may issue a final design
approval with appropriate terms and
conditions. The NRC’s approval of a
standard design is commonly referred to
as an FDA because it is an approval of
final design information.
Section 52.145 Finality of Standard
Design Approvals; Information Requests
This section states that a valid FDA
must be relied upon by the ACRS and
NRR in any review of a license
application that references the FDA
unless significant new information
substantially affects the staff’s FSER.
The Commission, Atomic Safety
Licensing Board Panel, or presiding
officers are not bound by NRC staff
determinations in the FDA or FSER for
the standard plant design. Therefore,
there is no issue preclusion in the
mandatory hearing for a combined
license that references an FDA. Generic
changes to the standard design can be
made as a compliance backfit or under
the backfit process in 10 CFR 50.109.
Under paragraph (c), the justification for
requests for information to FDA holders
must be approved by the EDO or his or
her designee, in accordance with the
process set forth in 10 CFR 50.54(f).
Section 52.147 Section Duration of
Design Approval
The purpose of this section is to
specify the time period that an FDA can
be referenced in a construction permit,
operating license, combined license, or
manufacturing license application.
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Section 52.155
Section 52.151 Scope of Subpart
This new section is analogous to the
‘‘scope of subpart’’ sections in subparts
A through C of part 52 (e.g., §§ 52.13,
52.41, 52.71). Section 52.151 describes
the general subject matter of subpart F
as the requirements and procedures
applicable to NRC issuance of licenses
authorizing the manufacture of nuclear
power reactors to be installed at sites
not identified in the manufacturing
license application. This subpart does
not cover the manufacture of
subcomponents (e.g., a pump or a
reactor pressure vessel) or major
subassemblies (e.g., an integrated
module consisting of a pump, piping
and instrumentation and control) for
installation in a nuclear power plant,
either on a specific site, or being
delivered for integration into a nuclear
power plant under a manufacturing
license issued under this subpart. For
purposes of this subpart, a
manufactured ‘‘nuclear power reactor’’
would not include site-specific SSCs
such as the site foundation or SSCs
related to the ultimate heat sink.
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Subpart F—Manufacturing Licenses
This new section is analogous to the
‘‘filing of applications’’ sections in
subparts A through C of part 52 (e.g.,
§§ 52.15, 52.45, 52.75). Section 52.155
addresses who may file an application
for a manufacturing license, the
administrative requirements with
respect to filing (referring to §§ 52.3 and
50.30), and the fees for filing and review
of the application (referring to 10 CFR
part 170). With respect to these matters,
a manufacturing license application is
no different than any other license
application under parts 50 or 52, and
the applicant shall comply with all of
these administrative requirements
(which have been revised as part of the
final rule to refer, as necessary, to
manufacturing licenses).
Section 52.153 Relationship to Other
Subparts
This new section is analogous to the
‘‘relationship to other subpart’’ sections
in subparts A through C of part 52 (e.g.,
§§ 52.13, 52.43, 52.73). Section 52.153
explains how this subpart relates to
other licensing processes in parts 50 and
52, as well as to the regulatory
approvals in part 52.
A manufactured reactor may only be
transported to and installed at a site for
which either a construction permit
under part 50 or a combined license
under part 52 has been issued to a
licensee, as stated in paragraph (a).
However, the licensing requirements
associated with transport of a
manufactured reactor from its place of
manufacture to the site where it is to be
installed and operated are not addressed
in this rulemaking.
The NRC will issue a manufacturing
license only if it approves the final
design of the reactor to be
manufactured. Paragraph (b) provides
that the manufacturing license applicant
may reference either a standard design
certification rule or a standard design
approval, in order to speed the NRC’s
review of the manufacturing license
application. The language of paragraph
(b) has been corrected in the final rule
by deleting the reference to
‘‘preliminary or final’’ design approvals,
inasmuch as the final part 52 rule does
not provide for preliminary design
approvals.
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Filing of Applications
Section 52.156 Contents of
Applications; General Information
This new section is analogous to the
‘‘contents of application; general
information’’ sections in subparts A
through C of part 52 (e.g., §§ 52.16,
52.46, 52.77). Section 52.156 requires
that the applicant include the
information set forth in § 50.33(a)
through (d) and (j), which are the same
information required to be supplied by
applicants of construction permits, early
site permits, operating licenses, and
combined licenses. Paragraphs (a)
through (d) of § 50.33 require an
application to include information
identifying the applicant, including its
name, address, business or occupation,
and certain corporate information,
including whether it is owned,
controlled, or dominated by an alien,
foreign corporation, or foreign
government. Paragraph (j) of § 50.33
requires the applicant to segregate and
protect any Restricted Data or other
defense information from unclassified
information. Manufacturing license
applicants should note that there are
other NRC requirements governing
Restricted Data or National Security
Information in other parts of 10 CFR
Chapter I, including 10 CFR parts 10,
50, and 95.
Section 52.157 Contents of
Applications; Technical Information in
Final Safety Analysis Report
This new section is analogous to the
‘‘contents of application; technical
information’’ sections in subparts A
through C of part 52 (e.g., §§ 52.17,
52.47, 52.79). Section 52.157 identifies
the technical information that must be
included in an application for a
manufacturing license. These
requirements were modeled on those
subparts, in particular subpart B’s
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provisions dealing with standard design
certifications, because of the
commonality with respect to the nature
and scope of NRC approval of the design
in both regulatory processes. As with
the existing part 50 licensing process,
and part 52’s combined license and
standard design certification processes,
the manufacturing license application
must include an FSAR. The FSAR
contains the information necessary for
the NRC to determine the safety of the
reactor design to be manufactured and
the adequacy of the applicant’s
proposed means of assuring that the
manufacturing conforms to the design.
The FSAR must contain a level of detail
sufficient to permit preparation of
construction and installation
specifications by an applicant who
seeks to use the manufactured reactor,
and for the NRC to prepare acceptance
and inspection requirements.
The information required to be
included in the manufacturing license
FSAR is largely the same as what is
required for a design certification or
combined license, but the requirements
have been modified as necessary to
reflect the fact that the design and
manufacture of a reactor is being
approved by license, but that the reactor
must be transported to a site and
integrated into site specific plant
elements in order to operate. In
addition, unlike the case with a design
certification, the NRC is not
distinguishing between evolutionary
plants versus more advanced plants
with respect to the level of detail
required to be developed to support the
license application. The NRC expects
that the designs of all manufactured
plants will be completed at a level of
detail sufficient for: (1) The holder of
the manufacturing license to develop
procurement, construction and
installation specifications; and (2) the
NRC to develop acceptance and
inspection requirements.
Paragraph (a) requires that the FSAR
contain the principal design criteria for
the reactor to be manufactured, and
references appendix A to 10 CFR part 50
as establishing minimum requirements
for the principal design criteria for
water-cooled nuclear power plants. The
NRC expects to develop technologyneutral design criteria for non-light
water cooled reactor designs in the
future. This requirement was drawn
from § 50.34(a)(3)(i).
Paragraph (b) requires that the FSAR
describe the design bases and the
relation of the design bases to the
principal design criteria that are
identified in accordance with paragraph
(a). This requirement was drawn from
§ 50.34(a)(3)(ii).
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Paragraph (c) requires that the FSAR
describe and analyze the structures,
systems, and components of the reactor
to be manufactured, with the objective
of demonstrating that the necessary
safety functions will be accomplished.
This requirement was drawn from
§ 50.34(a)(1) and (b)(2), but modified to
reflect the fact that a manufacturing
license represents approval of a final
reactor design.
Paragraph (d) requires that the FSAR
describe the safety features that are
engineered into the reactor. This
requirement was drawn from
§ 50.34(a)(1)(ii)(D), but modified to
reflect the fact that a manufacturing
license represents approval of a final
reactor design.
Paragraph (e) requires the FSAR to
describe the kinds and quantities of
radioactive materials expected to be
produced in the operation and the
means for controlling and limiting
radioactive effluents and radiation
exposures within the limits set forth in
part 20.
Paragraph (f) requires that the FSAR
include that information necessary to
establish that the design of the reactor
to be manufactured complies with 18
delineated technical requirements in 10
CFR part 50. Applicants and licensees
should note that the part 50
requirements listed in paragraph (f) do
not constitute the sum total of
requirements in part 50 for which either
an applicant for or holder of a
manufacturing license must comply
with in its application and throughout
the life of its license. Rather, the listed
requirements in paragraph (f) simply
represents the minimum necessary
content of the FSAR for a manufacturing
license. The part 50 requirements listed
in paragraph (e) are mainly applicable to
LWRs. Potential applicants and
licensees should also note that the NRC
may, in the future, adopt additional
technical requirements in part 50
applicable to LWRs. If the NRC believes
that future manufacturing license
holder’s compliance with that new
requirement must be documented and
controlled through the FSAR, the NRC
will make a conforming change in
§ 52.157 to refer to the new part 50
requirement. A similar course would
also be followed if the NRC backfits, in
accordance with the finality provisions
in § 52.171, the new requirement on
existing manufacturing licenses.
Paragraph (f)(19) requires that the
FSAR include the site parameters
postulated for the design of the
manufactured reactor. Although an
applicant for a manufacturing license
does not need to specify a particular site
where the manufactured reactor will be
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integrated into a nuclear power plant, as
in a combined license application, it
does need to identify the site
parameters, under paragraph (f)(20), that
the manufactured reactor is designed to
meet, e.g., postulated values for the safeshutdown earthquake response spectra
and maximum tornado wind speed.
These parameters are usually selected to
envelop a large portion of nuclear plant
sites in the United States. Once the
manufacturing license is issued by the
NRC, conformance of the actual site
with the established site parameters
must be demonstrated by the applicant
referencing the use of the manufactured
reactor.
Paragraph (f)(20) requires the FSAR to
describe the interface requirements for
those design features that are outside
the scope of the design of the
manufactured reactor, e.g., service water
intake structure or ultimate heat sink,
and paragraph (f)(21) requires
justification that compliance with the
interface requirements in paragraph (g)
can be verified through inspections or
tests (which may be conducted at the
plant where the manufactured reactor is
utilized, or elsewhere, e.g., the place of
manufacture) or analysis. This
paragraph does not require, however,
that the FSAR contain ‘‘acceptance
criteria’’ for determining whether the
interface requirements have been met.
Paragraph (f)(22) requires the FSAR to
include a representative conceptual
design for the nuclear power facility
using the manufactured reactor. This
will be used by the NRC in its review
of the FSAR, to assess the adequacy of
the interface requirements in paragraph
(g) of this section, and to help the
Commission in determining the
adequacy of the site parameters and
design characteristics to be included in
the manufacturing license. The
conceptual design will not, however, be
approved as part of the manufacturing
license and the Commission does not
anticipate directly requiring a nuclear
power plant utilizing the manufactured
reactor to use the conceptual design.
Instead, the Commission intends to use
site parameters, design characteristics,
ITAAC, and interface requirements to
ensure that the manufactured reactor
will be utilized safely at a specific
nuclear power plant.
Paragraph (f)(23) requires the
applicant to provide a description and
analysis of design features to address
prevention and mitigation of severe
accidents, consistent with the
Commission’s SRM on SECY–91–229,
‘‘Severe Accident Mitigation Design
Alternatives for Certified Standard
Designs,’’ dated October 25, 1991.
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Paragraph (f)(U0 ) is reserved to
accommodate any new requirement for
the contents of an FSAR submitted as
part of an application for a
manufacturing license which the
Commission may adopt in the future.
Paragraph (f)(25) requires FSARs for
modular nuclear power plant designs to
describe and analyze the various
options for the configuration of the
multi-reactor nuclear power plant.
Modular nuclear power plant designs
are defined in § 52.1. Modular designs
are not portions of a single nuclear
plant, rather they are separate nuclear
reactors with some shared or common
systems.
Paragraphs (f)(26)(i), (ii), (iii), and (v)
focus on FSAR information necessary to
demonstrate applicants technical,
managerial, and organizational
capability and resources to design and
manufacture a nuclear power reactor
consistent with the approved design,
and in accordance with all applicable
requirements.
Paragraph (f)(26)(iv) requires the
FSAR to include proposed procedures
for the preparation of the manufactured
reactor for shipping, the conduct of
shipping, and for verifying the
condition of the manufactured reactor
upon receipt at the site. However, the
holder of the manufacturing license
need not be responsible for
implementing the procedures for
verifying the condition of the reactor
upon receipt at the site. The NRC will
require the licensee whose application
referenced the use of the manufactured
reactor to implement the approved
verification procedures (this could be
done as a license condition). With
respect to shipping, the holder of the
manufacturing license may use an agent
(e.g., a shipping company) to transport
the reactor. To ensure that the shipping
requirements in the manufacturing
license are complied with by the third
party transporter, the NRC has included
a provision in § 52.167(c)(2) requiring
the manufacturing license holder to
include, in any contract governing the
transport of a manufactured reactor from
the place of manufacture to any other
location, a provision requiring that the
person or entity transporting the
manufactured reactor to comply with all
NRC-approved shipping requirements in
the manufacturing license.
For plant designs that are based on or
are evolutions of nuclear plants that
have operated in the United States,
paragraph (f)(29) requires the applicant
to demonstrate how relevant operating
experience insights, from NRC’s generic
letters and bulletins issued after the
most recent revision of the applicable
SRP and 6 months before the docket
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date of the application, have been
incorporated into the design of the
reactor to be manufactured. Operating
experience includes consideration of
operating events and the reliability and
performance of structures, systems, and
components. If the application is for a
design that is not based on or is not an
evolution of a nuclear plant that
operated in the United States, the
applicant must demonstrate how
insights from any relevant international
operating experience have been
incorporated into that manufactured
reactor design.
Paragraph (f)(31) requires that the
FSAR include a description of the
design—specific probabilistic risk
assessment and its results.
Section 52.158 Contents of
Application; Additional Technical
Information
This new section is analogous, in
organizational structure, to § 52.80,
‘‘Contents of application; additional
technical information’’ in subpart C of
part 52.
Paragraph (a) requires that the
application include inspections, tests,
and analyses that the licensee who will
be placing the manufactured reactor on
a site and operating the reactor shall
perform and their associated acceptance
criteria. The purpose of these ITAAC are
to ensure that: (1) The reactor has been
manufactured in conformance with
applicable requirements; and (2) the
manufactured reactor, as emplaced at
the site and integrated into any sitespecific portions of the nuclear power
plant, will operate in conformance with
the design characteristics in the
manufacturing license, the license
authorizing operation of the
manufactured reactor, and applicable
requirements. Paragraph (a)(3), which is
analogous to § 52.80(a)(3), provides that
if the manufacturing license references
a standard design certification, the
manufacturing license application may
include a notification that one or more
ITAAC in the referenced design
certification rule has been met. In such
a situation, the Federal Register notice
of docketing a hearing required by
§ 52.163 must specifically indicate that
the application includes such a
notification.
Paragraph (b)(1) requires that the
application include an environmental
report meeting the requirements in 10
CFR 51.54, which specifies the
environmental information that must be
submitted by a manufacturing license
applicant to support the NRC’s NEPA
review. The Commission notes that
environmental report need not include
a discussion of assessment of the
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benefits and impacts of constructing and
operating the manufactured reactor or
an evaluation of alternative energy
sources, under § 52.163 and § 51.54.
Under § 51.54, the environmental
report for a manufacturing license must
address the costs and benefits of
SAMDAs that could be incorporated
into the design, and the bases for not
including SAMDAs into the design. The
SAMDA information that must be
included is essentially the same
information that must be provided to
support an application for a standard
design certification. However, if the
application references a standard design
certification, § 51.54 provides that the
manufacturing license’s environmental
report need not include the SAMDA
evaluation. In such a case, the SAMDA
determination in the EA for the
referenced design certification would
have finality in the manufacturing
license proceeding, in accordance with
§ 52.63.
Section 52.159 Standards for Review
of Applications
This new section is analogous to the
‘‘standards for review of applications’’
sections in subparts A through C of part
52 (e.g., §§ 52.18, 52.48, 52.81). Section
52.159 identifies the regulations that the
NRC will use in reviewing an
application for a manufacturing license.
The NRC recognizes that reactors to be
manufactured under a manufacturing
license may incorporate design features
which are inconsistent with current
requirements in 10 CFR Chapter I, and
may require exemptions from current
requirements. Such exemptions would
be granted as part of the NRC’s issuance
of the manufacturing license, together
with alternative requirements
(analogous to the ‘‘applicable
regulations’’ provisions in the current
design certifications rules, 10 CFR part
52, appendices A–D, Section V).
Section 52.163 reiterates the § 2.105
requirement that the NRC publish in the
Federal Register a notice of proposed
action on the application. Apart from
the required Federal Register notice, the
Commission also expects to publish on
the NRC’s Web site notice of docketing
of the application and the opportunity
to intervene in the proceeding,
consistent with the Commission’s
discussion in the 2004 final part 2
rulemaking (January 14, 2004; 69 FR
2182, 2198–99). The section makes
clear, consistent with § 51.54, that the
environmental report submitted by the
manufacturing license applicant need
not contain an assessment of the
benefits of constructing and/or
operating the manufactured reactor or
an evaluation of alternative energy
sources.
Finally, this section indicates that the
hearing on the manufacturing license
application will be governed by the
procedures in part 2, subparts C, G, L,
and N. The Commission notes that
although subpart G is listed in this
paragraph, it is unlikely that there
would be contentions meeting the
criteria in § 2.310 (and reiterated in
§ 2.700) for conduct of the hearing
under subpart G. This is because the
primary focus of the manufacturing
license proceeding is on the adequacy of
the design to be manufactured, and the
nature of issues which are most likely
to be raised on the design would not
ordinarily involve issues of material fact
relating to either: (1) The occurrence of
a past activity, where the credibility of
an eyewitness may reasonably be
expected to be at issue; or (2) issues of
motive or intent of the party or
eyewitness which are material to the
resolution of the contested matter.
Section 52.163 Administrative Review
of Applications; Hearings
Section 52.165 Referral to the
Advisory Committee on Reactor
Safeguards (ACRS)
This new section is analogous to the
‘‘Referral to the Advisory Committee on
Reactor Safeguards’’ sections in subparts
A through C of part 52 (e.g., §§ 52.21,
52.53, 52.87). It provides that the ACRS
will have the same role with respect to
manufacturing licenses that it has for
other nuclear power plant licenses, in
that it will report on those portions of
the application which concern safety.
This new section is analogous to the
‘‘administrative review of applications’’
sections in subparts A through C of part
52 (e.g., §§ 52.21, 52.51, 52.85). Section
52.163 specifies that the procedural
requirements in 10 CFR part 2 apply to
the NRC’s processing of an application
for a manufacturing license, including
docketing of the initial application.
Section 52.167 Issuance of
Manufacturing License
This new section is analogous to the
‘‘issuance’’ sections in subparts A
through C of part 52 (e.g., §§ 52.24,
52.54, 52.97). Paragraph (a) sets forth
the timing of issuance of a
manufacturing license and the findings
that the Commission must make in
Section 52.161
Reserved
This section is reserved to
accommodate any new requirements on
the application process for
manufacturing license which the NRC
may adopt in the future.
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order to issue the manufacturing
license. The findings that must be made
are similar to those necessary to issue a
construction permit, inasmuch as
construction is analogous to
manufacturing. The Commission notes
that it reserves the right to withhold
issuance of the manufacturing license,
even if all the rules and regulations of
the Commission have been satisfied,
based on public health and safety or
common defense and security
information or considerations not
adequately addressed in the
Commission’s rules and regulations.
Paragraph (b) identifies the specific
limitations that the Commission will
include in each manufacturing license.
They include technical specifications
for the operation of each manufactured
reactor, site parameters, design
characteristics, and interface
requirements, which are to be used by
the applicant for and holder of the
license referencing the use of the
manufactured reactor(s). Ordinarily, the
limitations to be included in the
manufacturing license would be derived
from the manufacturing license
application, but the NRC may modify
the proposed limitations based upon the
NRC’s review.
Paragraph (c) restricts the holder of
the manufacturing license from
transporting or allowing to be removed
from the place of manufacture the
manufactured reactor except to the site
of a licensee who holds either a
construction permit or combined license
referencing the use of that manufactured
reactor.
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Section 52.169 Reserved
This section is reserved to
accommodate any new requirements on
either the issuance of, or activities
authorized under a manufacturing
license which the Commission may
adopt in the future. Any new
requirements adopted after issuance of a
manufacturing license, which are made
applicable to that manufacturing
license, would have to satisfy the
finality restrictions in § 52.171.
Section 52.171 Finality of
Manufacturing Licenses; Information
Requests
This new section is analogous to the
variously entitled sections addressing
finality and special backfitting
protections which are in subparts A
through C of part 52 (e.g., §§ 52.39,
52.63, 52.98),15 but is more generally
15 The finality provision in § 52.83 performs a
different function than the finality sections cited
above, in that it points back to, and thereby reemphasizes, the primary finality provisions for each
license or regulatory approval mechanism in part
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modeled on the finality provision for
standard design certifications. In
general, paragraph (a) addresses
backfitting and finality restrictions on
the NRC, paragraph (b) addresses
finality and standardization restrictions
applicable to the licensee (i.e., the
holder the manufacturing license), and
paragraph (c) establishes restrictions on
certain NRC information collections
with respect to the manufacturing
license.
Paragraph (a)(1) states that the
Commission may not modify, rescind,
or impose new requirements on the
design of a nuclear power reactor being
manufactured, or new requirements for
the manufacture of the nuclear power
reactor, unless the Commission
determines that a modification is
necessary to either bring the design or
the manufacture of the reactor into
compliance with the Commission’s
requirements applicable and in effect at
the time the manufacturing license was
issued, or to provide reasonable
assurance of adequate protection to
public health and safety or common
defense and security. This restriction on
the Commission applies, inter alia, in
construction permit, operating license,
and combined license proceedings
which reference the use of the
manufactured reactor. It also applies in
any enforcement proceeding initiated by
the NRC, or in a rulemaking which
proposes to apply new or changed
requirements to reactors which have
already been manufactured, as well as
any reactors yet to be manufactured
under the manufacturing license.
However, the restrictions in paragraph
(a)(1) do not apply to NRC information
requests directed at either the
manufacturing license holder, or to any
holder of a license referencing the use
of a manufactured reactor; such
information requests are governed by
paragraph (c) of this section.
Paragraph (a)(2) provides that any
modification to the design of a
manufactured nuclear power reactor
which is imposed by the Commission
under paragraph (a)(1) of this section
will be applied to all reactors
manufactured under the license,
including those that have already been
manufactured, transported, sited, and
are in operation. The only exception
would be for those reactors to which the
Commission-ordered modification had
been rendered technically irrelevant by
action taken under paragraph (b) of this
section, i.e., either the holder of the
manufacturing license has requested a
change to the design approved in the
52, e.g., the finality provision in § 52.39 for early
site permits.
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manufacturing license (which ordinarily
would apply only to reactors
manufactured after Commission
approval of the change), or the holder of
a license referencing the use of the
manufactured reactor has obtained
Commission approval for a change to
the design of the specific manufactured
reactor(s) utilized by that licensee.
Paragraph (a)(3) delineates the nature
of finality associated with the
referencing of a manufactured reactor in
subsequent NRC licensing proceedings.
This paragraph provides that finality is
accorded to those matters resolved in
the proceeding on the issuance or
renewal of the manufactured reactor.
These matters resolved include the
adequacy of the design of the
manufactured reactor and the
acceptability and completeness of the
ITAAC required by § 52.158(a)(1) to be
performed by the licensee operating the
reactor. The matters resolved also
include the SAMDA evaluation
prepared by the Commission in
compliance with its obligations under
NEPA. This finality extends to both the
Commission’s determinations with
respect to specific SAMDA features
included in the design of the
manufactured reactor, as well as the
Commission’s determinations regarding
the lack of need for any other SAMDA
features. Finality is accorded in the
following situations: (1) Issuance of a
construction permit, operating license,
combined license; (2) any hearing under
§ 52.103; and (3) enforcement hearings
other than those proceedings initiated
by the Commission under paragraph
(a)(1).
Paragraph (b)(1) requires the holder of
a manufacturing license to seek a prior
NRC review and approval for any
change to the design of the nuclear
power plant authorized to be
manufactured. The holder of the
manufacturing license may not make a
change to the approved design for
manufacture through the provisions of
§ 50.59. A request for a change to the
approved design must be in the form of
a license amendment application, and
the application will be processed in
accordance with §§ 50.90 through 50.92.
The Commission notes, however, that
the procedures for no significant
hazards consideration (NSHC) are not
applicable to manufacturing licenses,
inasmuch as Section 189.a.(2) of the
AEA, which is the statutory authority
for these procedures, does not apply to
manufacturing licenses.
Paragraph (b)(2) requires a holder of a
license referencing the use of a
manufactured reactor, who wishes to
depart from the design characteristics,
site parameters, terms and conditions,
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or approved design of the manufactured
reactor, to seek a departure from the
NRC. The manner in which a departure
is granted depends upon the timing of
the request. If a departure is requested
as part of the initial combined license
application, the departure would be
treated as part of the application and
issued as part of the combined license.
By contrast, if the same departure were
sought after the combined license had
been issued, then the licensee must
apply for the departure in the form of a
license amendment. The criteria for
granting the departure is the exemption
criterion in § 52.7; however, the
departure itself is not considered an
exemption (unless, of course, the
departure also involves a noncompliance with an underlying
Commission regulatory requirement in
10 CFR Chapter I). Thus, the
Commission will not approve a
departure unless the Commission finds,
in addition to the routine exemption
criteria in § 52.7, that special
circumstances outweigh any decrease in
safety that may result from the
reduction in standardization caused by
the departure. As explained earlier,
these limitations are intended to
maintain the standardization of
manufactured reactors in operation to
the extent practicable. The licensee may
not depart from the design
characteristics, site parameters, terms
and conditions, or approved design of
the manufactured reactor through the
provisions of § 50.59.
Paragraph (c), which is analogous to
§§ 52.39(d), 52.98(g), and 52.145(c),
provides that NRC information requests
must be evaluated before issuance to
ensure that the burden to be imposed by
the information request is justified in
view of the potential safety significance
of the issue to be addressed, except
when the information requests seeks to
verify compliance with the current
licensing basis of either the
manufacturing license or the
manufactured reactor. This paragraph
applies to information requests directed
at either the holder of the manufacturing
license or the holder of a license
referencing the use of a manufactured
reactor. Information requests may be in
the form of a new rule requiring
submission of information (i.e., a new
information collection and reporting
requirement), or in the form of a NRC
staff request for information.
Information requests by the staff must
be in accordance with 10 CFR 50.54(f)
and must be approved by the EDO or his
or her designee before the request may
be issued.
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Section 52.173 Duration of
Manufacturing License
This new section is analogous to the
variously-entitled sections addressing
duration (term) of each regulatory
process in subparts A through C of part
52 (e.g., §§ 52.33, 52.61, 52.104). Under
§ 52.173, a manufacturing license may
be issued for not less than 5 nor more
than 15 years. Manufacturing of a new
reactor may not commence less than 3
years before the expiration of the
manufacturing license, even though a
timely application for renewal has been
filed in accordance with § 52.177.
However, if a timely application for
renewal of the manufacturing license
has been docketed, manufacturing of
uncompleted reactors whose
manufacture commenced 3 years or
more before the expiration date, may
continue past the date of expiration of
the license until the NRC acts upon the
renewal application, consistent with the
‘‘Timely Renewal’’ doctrine of the
Administrative Procedures Act. The
NRC believes that timely renewal
protection should only be provided to
those applications which are of
sufficient quality to be docketed. This is
consistent with the requirement in
§ 2.109(b) requiring filing of a
‘‘sufficient’’ application for renewal of
operating licenses as a prerequisite for
the applicability of the timely renewal
protection.
§§ 52.29, 52.57, 52.107). Section 52.177
sets forth the content of an application
for renewal, specifies the administrative
requirements governing the application,
addresses the effectiveness of a
manufacturing license during the period
of NRC’s consideration of the renewal
application, summarizes how an
interested person may request a hearing
on the renewal, and addresses the
referral of the renewal application to the
ACRS and the Commission’s
expectations with respect to the ACRS
report on the application.
Section 52.179
Criteria for Renewal
Section 52.177 Application for
Renewal
This new section is analogous to the
‘‘application for renewal’’ sections in
subparts A through C of part 52 (e.g.,
This new section is analogous to the
‘‘criteria for renewal’’ sections in
subparts A and B of part 52 (e.g.,
§§ 52.31, 52.59).17 Section 52.179
provides that the Commission may grant
renewal of a manufacturing license if
the Commission determines that the
license complies with the relevant
provisions of the AEA, the
Commission’s regulations applicable
and in effect at the time the
manufacturing license was originally
issued, and any new requirements
which the Commission imposes which:
(1) Are necessary for reasonable
assurance of adequate protection to
public health and safety or common
defense and security; (2) are necessary
for compliance with Commission’s
regulations and orders applicable and in
effect at the time the manufacturing
license was originally issued; or (3)
represent a substantial increase in
overall protection of the public health
and safety or common defense and
security and the direct and indirect
costs of implementation are justified in
light of the increased protection. These
‘‘backfitting’’ restrictions are similar
to—if somewhat narrower than—the
backfitting restrictions applicable to
renewal of standard design certification
rules under subpart B of this part.
Reasonable assurance of adequate
protection to public health and safety
and common defense and security is
provided under this regulatory
approach, inasmuch as paragraph (b)
allows the Commission to impose new
requirements which are necessary for
common defense and security, or are
necessary for compliance with the
Commission’s regulations and orders
applicable and in effect at the time the
manufacturing license was originally
issued.
16 A standard design certification is a rule, rather
than a license. Accordingly, there is no ‘‘holder’’ of
a standard design certification rule and no need for
a provision addressing ‘‘transfer’’ of a standard
design certification rule.
17 Subpart C does not contain a ‘‘criteria for
renewal’’ provision, inasmuch as the renewal
would be governed by 10 CFR part 54, see § 52.107.
Part 54 contains a provision, § 54.29, setting forth
the standards for issuance of renewed licenses.
Section 52.175 Transfer of
Manufacturing License
This new section is analogous to the
variously entitled transfer sections in
subparts A and C of part 52 (e.g.,
§§ 52.28, 52.105).16 Section 52.175
provides that a manufacturing license
may be transferred in accordance with
§ 50.80, which constitutes the
Commission’s common procedures and
criteria governing transfers of nuclear
power plant licenses. The matters to be
addressed in a transfer are limited to the
matters identified in § 50.80(b), and the
transfer would not be an opportunity for
the Commission to reconsider safety and
environmental matters previously
resolved, or to address new safety
matters other than the narrow scope of
matters identified in § 50.80(b).
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Section 52.181
Duration of Renewal
This new section is analogous to the
‘‘duration of renewal ’’ sections in
subparts A and B of part 52 (e.g.,
§§ 52.33, 52.61).18 Section 52.181
specifies the term of a renewed
manufacturing license as not less than 5
nor more than 15 years from the date of
expiration of the prior manufacturing
license. Thus, a holder of a
manufacturing license with an original
term of 15 years, who is granted a 15year renewal of the manufacturing
license 4 years before expiration of the
license, will obtain a renewed
manufacturing license of 19 years,
representing a 15-year term of the
renewed license plus the 4 years
remaining on its original license.
Subpart G—Reserved
This subpart is reserved for future use
by the Commission.
Subpart H—Enforcement
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This subpart contains two provisions,
§ 52.301 and § 52.303, which are
comparable to former § 52.111 and
§ 52.113, and are analogous to
provisions contained in other parts of 10
CFR Chapter I imposing requirements
on regulated entities.
Section 52.301 reiterates, and
provides notice to licensees and
applicants under part 52 of the
Commission’s authority to obtain
injunctions or other court orders for the
violations enumerated in this paragraph.
Section 52.303 provides notice to all
persons and entities subject to part 52
that they are subject to criminal
sanctions for willful violations,
attempted violations, or conspiracy to
violate certain regulations under part
52. The regulations for which criminal
penalties apply are limited to those
which establish either a regulatory
obligation or prohibition. Most of the
regulations in part 52 are procedural or
administrative in nature, and therefore
were listed in § 52.113 as not being
subject to criminal sanctions. The
regulations in part 52 which are subject
to criminal sanctions are §§ 52.4
(Deliberate misconduct), 52.5 (Employee
protection), 52.6 (Completeness of
information), 52.25 (Extent of activities
permitted), 52.35 (Use of site for other
purpose), 52.91 (Authorization to
conduct site activities), and 52.110
(Termination of license).
18 Subpart C does not contain a ‘‘duration of
renewal’’ provision, inasmuch as the renewal
would be governed in all respects by 10 CFR part
54, see § 52.107. Part 54 contains a provision,
§ 54.31, governing the duration of renewed licenses.
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Appendix A—U.S. Advanced Boiling
Water Reactor
Refer to the section-by-section
discussion in the final rule dated May
12, 1997 (62 FR 25800).
Appendix B—The System 80+ Design
Refer to the section-by-section
discussion in the final rule dated May
21, 1997 (62 FR 27840).
Appendix C—The AP600 Design
Refer to the section-by-section
discussion in the final rule dated
December 23, 1999 (64 FR 72002).
Appendix D—The AP1000 Design
Refer to the section-by-section
discussion in the final rule dated
January 27, 2006 (71 FR 4464).
Appendix N—Combined Licenses for
Nuclear Power Reactors of Identical
Design
Appendix N of part 52 contains the
Commission’s procedures which may be
used by one or more applicants for
combined licenses under part 52, where
the applications seek to construct and
operate nuclear power reactors of
identical design to be located at
multiple sites. The comparable
procedures governing applications for
construction permits and operating
licenses using identical nuclear power
reactor designs remain in appendix N of
10 CFR part 50. Hearings for
applications filed under appendix N in
part 52, as well as part 50, are governed
by subpart D of part 2. Thus, appendix
N and subpart D of part 2 are integral
to each other.
The regulations in appendix N of part
52 apply in two situations: (1) Where
the same applicant seeks combined
licenses at different sites utilizing the
identical reactor design; and (2) where
two or more different applicants each
seek combined licenses at different sites
utilizing the identical reactor design. In
either situation, there is an identical
reactor design. The Commission has
deliberately used the term, ‘‘nuclear
power reactor,’’ in appendix N and
subpart D of part 2—as distinguished
from the term, ‘‘nuclear power plant’’—
to make clear that the site-specific
elements, such as the service water
intake structure or the ultimate heat
sink, need not be identical in order for
appendix N and subpart D to apply.
The Commission has conformed
appendix N and subpart D of part 2 to
use the term, ‘‘identical’’ nuclear power
reactor design, and removed references
to ‘‘duplicate’’ and ‘‘essentially
identical.’’ For purposes of appendix N
and subpart D of part 2, designs for
reactors are ‘‘identical,’’ even if
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individual licensees request plantspecific departures or exemptions from
a referenced standard design
certification (or application). However,
those plant-specific departures or
exemptions are not part of the ‘‘common
design.’’ Therefore, the NRC’s review of
those departures and exemptions, as
well as NRC hearings on those
departures and exemptions, would be
conducted separately as part of the
safety review of each individual
application, and would not be part of
the hearing on the common design
which would be conducted under
subpart D of part 2.
Section 1
This is a new section specifying that
its provisions apply to applicants for
combined licenses under subpart C of
part 52. Appendix N of part 50 would
apply to applicants for construction
permits and operating licenses who use
identical reactor designs.
Section 2
This section, which is analogous to
and derived from former § 2 of appendix
N, specifies that each application
submitted under this appendix must be
submitted in accordance with the
delineated Commission filing
requirements. In addition, to ensure that
the NRC is clearly informed that the
applicants wish to have their
application processed under appendix
N and subpart D of part 2, this section
requires: (1) That each application state
the applicant’s intent that the
application be processed by the NRC
under appendix N; and (2) that all of the
applications to be treated together under
this appendix be listed in each
application. All of the applications must
be filed simultaneously, which will
facilitate NRC’s administrative handling
and technical review of the
applications, as well as efficient
conduct of the hearing process.
Section 3
This section, which is analogous to
and derived from former § 3 of appendix
N, specifies that combined license
applications submitted under this
appendix must include all of the
information required to be submitted in
a combined license application in
§§ 52.77, 52.79, and 50.80(a) and (b), but
makes clear that each of the applications
must identify the common design. The
common design may be (but is not
limited to) a standard design
certification under subpart B of part 52,
a standard design approval, a ‘‘common
custom design,’’ or a manufactured
reactor.
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The FSAR for each application must
either incorporate by reference or
include the FSAR for the common
design, including, as applicable, the
FSAR for the referenced design
certification or manufactured reactor.
‘‘Include,’’ means that the FSAR may
not simply reference the common FSAR;
the information from the referenced
FSAR must be included within each
application’s FSAR.
Section 4
This is a new section specifying that
each application must submit an
environmental report which complies
with the applicable provisions of part 51
with respect to the content of
environmental reports. As an
alternative, this section provides that
one or more of the applicants’
environmental reports may incorporate
by reference a single environmental
report describing the environmental
impacts of the common design at each
of the sites.
Section 5
This is a new section specifying that,
upon a determination that each
application is acceptable for docketing,
each application will be docketed and a
notice of docketing will be published in
the Federal Register in accordance with
10 CFR 2.104. The notice of docketing
must state that the application will be
processed under the provisions of
appendix N. Separate notices of
docketing are contemplated, so that a
problem with acceptance review of one
application will not prevent the
docketing and initiation of the NRC’s
technical review of the other
applications determined to be sufficient
and acceptable for docketing. This could
occur, for example, if information,
submitted by an applicant which is
unrelated to the common design, is
determined by the NRC to be
insufficient. However, if the
applications are determined to be
acceptable for docketing, § 5 provides
the Commission with the discretion to
publish a single notice of docketing for
those applications.
Section 6
This is a new section which provides
that the NRC will prepare a separate
draft and final EIS for each of the
applications. Scoping may be conducted
simultaneously but need not be
conducted jointly (e.g., scoping for an
application at site 1 need not be
conducted as part of the same process
as the scoping for an application for site
2), at least with respect to site-specific
environmental issues. However, for
environmental issues related to the
common design, the NRC has the
discretion to conduct joint scoping. The
NRC staff is not, however, required to
prepare a joint environmental impact
statement for the common design.
This section also addresses the
content of an EIS when the applications
reference either a standard design
certification or the use of a
manufactured reactor of common
design. In either case, the NRC has
already prepared and finalized an EA
which addresses SAMDAs. This
SAMDA analysis is accorded finality
under the provisions of §§ 52.63 and
52.171, respectively. Therefore, the EIS
for each of the applications must
reference the relevant environmental
assessment containing the SAMDA
analysis.
Section 7
This section, which is analogous to
and derived from former § 1 of appendix
N, provides direction to the ACRS with
respect to their report on each of the
combined license applications. The
ACRS must issue a separate report on
the safety of the common design, except
in those instances where the
applications are referencing either a
standard design certification or
manufactured reactor (of common
design). In addition, the ACRS must
issue a separate report for each
application. This report must be limited
to those matters which are not relevant
to the common design. This will
Document
PDR
rwilkins on PROD1PC63 with RULES2
Part 52 Rule, Cross-Reference Tables ...........................................................
Comments received .........................................................................................
Comment Summary Report .............................................................................
Regulatory Analysis .........................................................................................
Regulatory History Index for the proposed July 2003 rule ..............................
Regulatory History Index for the March 13, 2006, proposed rule ...................
VIII. Agreement State Compatibility
Under the ‘‘Policy Statement on
Adequacy and Compatibility of
Agreement State Programs’’ which
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Section 8
This is a new section, which provides
that the Commission shall designate a
presiding officer to conduct the
proceeding with respect to the health
and safety, common defense and
security, and environmental matters
(i.e., SAMDAs) relating to the common
design. The presiding officer will
conduct the hearing in accordance with
subpart D of part 2. The presiding
officer is required to issue a separate
partial initial decision on matters
relevant to the common design,
consistent with 10 CFR 2.405 in subpart
D of part 2. Appeals of the partial initial
decision are governed by 10 CFR 2.341,
as provided by 10 CFR 2.405. The NRC
also notes that issues on the contested
design may not be relitigated in a
different phase of the hearing except on
the basis of significant new information
that substantially affects the
conclusion(s) reached at the other phase
or other good cause. See 10 CFR 2.406.
VII. Availability of Documents
The NRC is making the documents
identified below available to interested
persons through one or more of the
following methods as indicated.
Public Document Room (PDR). The
NRC Public Document Room is located
at 11555 Rockville Pike, Rockville,
Maryland.
Rulemaking Web site (Web). The
NRC’s interactive rulemaking Web site
is located at https://ruleforum.llnl.gov.
These documents may be viewed and
downloaded electronically via this Web
site.
NRC’s Public Electronic Reading
Room (EPDR). The NRC’s electronic
public reading room is located at
https://www.nrc.gov/reading-rm.html.
The NRC staff contact. Nanette V.
Gilles, Mail Stop O–4D9A, Washington,
DC 20555–0001, 301–415–1180.
Web
EPDR
X
X
X
X
X
became effective on September 3, 1997
(62 FR 46517), NRC program elements
(including regulations) are placed into
compatibility categories A, B, C, D,
PO 00000
facilitate the NRC’s licensing process by
eliminating overlap and ensuring that
the ACRS reports are carefully focused
on the relevant safety issues.
ML062550246
X
ML063450216
ML071490350
ML032810026
ML062080575
NRC staff
X
X
NRC, or adequacy category, Health and
Safety (H&S). Category A includes
program elements that are basic
radiation protection standards or related
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Federal Register / Vol. 72, No. 166 / Tuesday, August 28, 2007 / Rules and Regulations
definitions, signs, labels, or terms
necessary for a common understanding
of radiation protection principles and
should be essentially identical to those
of NRC. Category B includes program
elements that have significant direct
transboundary implications and should
be essentially identical to those of the
NRC. Compatibility Category C includes
program elements that do not meet the
criteria of Category A or B, but the
essential objectives of which an
Agreement State should adopt to avoid
conflict, duplication, gaps, or other
conditions that would jeopardize an
orderly pattern in the regulation of
agreement material on a nationwide
basis. Compatibility Category D includes
those program elements that do not
meet any of the criteria of Category A,
B, or C, and do not need to be adopted
by Agreement States. Compatibility
Category NRC includes program
elements that address areas reserved to
the Commission and cannot be
relinquished to Agreement States
pursuant to the Atomic Energy Act or
provisions of Title 10 of the Code of
Federal Regulations. An Agreement
State may inform its licensees of certain
of these NRC provisions through a
mechanism that is appropriate under
the State’s administrative procedure
laws as long as the State adopts these
49461
provisions solely for the purposes of
notification, and does not exercise any
regulatory authority pursuant to them.
Category H&S include program elements
that are not required for compatibility,
but have a particular health and safety
role in the regulation of agreement
material and the State should adopt the
essential objectives of the NRC program
elements. In addition, a State should not
adopt provisions that would preclude,
or effectively preclude, a practice
authorized by the Atomic Energy Act,
and in the national interest. The
proposed revisions are categorized as
follows:
LIST OF CHANGES 10 CFR PART 52 FINAL RULEMAKING
Description new,
changes
Compatibility designation
Comments regarding compatibility designation
10 CFR Part 1 .................
Statement of Organization and General Information.
D ....................................
This provision is designated Category D because it does not
meet any of the criteria of Category A, B, or C. A State
may adopt similar provisions to reflect their organizational
structure and may wish to inform its licensees of the provisions of this part through a mechanism that is appropriate
under the State’s administrative procedure laws.
10 CFR Part 2—Rules of
Practice for Domestic
Licensing Proceedings
and Issuance of Orders
2.1 .............................
Scope ............................
D, except portions of
these provisions are
NRC.
2.4—Definitions ........
Contested proceeding ...
D, except portions of the
definition are NRC.
License ..........................
rwilkins on PROD1PC63 with RULES2
Sections
NRC ...............................
Licensee ........................
[D] ..................................
These provisions are designated Compatibility Category D
because they do not meet any of the criteria of Category A,
B, or C. A State may adopt similar provisions that are compatible with the orderly pattern of regulation established by
the Atomic Energy Act, as amended (Act) and are consistent with their regulatory authority. Those portions of the
provision that address areas reserved to the NRC, e.g., 10
CFR Part 52 standard design approvals, are designated as
a Compatibility Category NRC. A State should not adopt
provisions that would confer regulatory authority to the
State in an area of exclusive NRC jurisdiction pursuant to
the Act, 10 CFR 8.4, 10 CFR Part 150, and other Federal
laws, regulations, or provisions.
This definition is designated Category D because it does not
meet any of the criteria of Category A, B, or C. A State
may adopt a similar definition that is compatible with the orderly pattern of regulation established by the Atomic Energy Act, as amended (Act) and is consistent with their regulatory authority. Those portions of the definition that address areas reserved to the NRC, e.g., 10 CFR Part 52 activities, are designated as a Compatibility Category NRC. A
State should not adopt provisions that would confer regulatory authority to the State in an area of exclusive NRC jurisdiction pursuant to the Atomic Energy Act, 10 CFR 8.4,
10 CFR Part 150, and other Federal laws, regulations, or
provisions.
This definition is designated Compatibility Category NRC because it addresses areas reserved to the NRC. A State
should not adopt provisions that would confer regulatory
authority to the State in an area of exclusive NRC jurisdiction pursuant to the Atomic Energy Act, 10 CFR 8.4, 10
CFR Part 150, and other Federal laws, regulations, or provisions. For purposes of compatibility, States should use
the language of the 10 CFR 20.1003 definition, except
those portions of the definition that reference areas reserved to the NRC, e.g., 10 CFR Parts 50, 60, 63, and 72,
are designated as a Compatibility Category NRC.
This definition also appears in 10 CFR 20.1003. For purposes
of compatibility, the language of the Part 20 definition
should be used where it is assigned to Compatibility Category D.
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LIST OF CHANGES 10 CFR PART 52 FINAL RULEMAKING—Continued
Description new,
changes
Sections
Compatibility designation
All of the sections covered by Subparts A,
B, and C.
D, except portions of
these provisions are
NRC.
2.400 thru 2.629 .......
All of the sections covered by Subparts D,
E, and F.
NRC, for all of the sections.
2.800 .........................
Scope and applicability
D, except portions of
these provisions are
NRC.
2.801 .........................
Initiation of rulemaking ..
D, except portions of
these provisions are
NRC.
2.811 .........................
Filing of standard design
certification application, required copies.
NRC ...............................
2.813 .........................
Written communications
NRC ...............................
2.815 .........................
rwilkins on PROD1PC63 with RULES2
2.100 thru 2.390 .......
Docketing and acceptance review.
NRC ...............................
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Comments regarding compatibility designation
These provisions are designated Compatibility Category D
because they do not meet any of the criteria of Category A,
B, or C. A State may adopt similar provisions that are compatible with the orderly pattern of regulation established by
the Atomic Energy Act, as amended (Act) and are consistent with their regulatory authority. Those portions of the
provision that address areas reserved to the NRC, e.g., 10
CFR Parts 50, 51, 52, 53, 54, 55, 60, 63, 72, 73, and 76,
are designated as a Compatibility Category NRC. A State
should not adopt provisions that would confer regulatory
authority to the State in an area of exclusive NRC jurisdiction pursuant to the Act, 10 CFR 8.4, 10 CFR Part 150,
and other Federal laws, regulations, or provisions.
These provisions are designated Compatibility Category NRC
because they address areas reserved to the NRC. A State
should not adopt provisions that would confer regulatory
authority to the State in an area of exclusive NRC jurisdiction pursuant to the Atomic Energy Act, 10 CFR 8.4, 10
CFR Part 150, and other Federal laws, regulations, or provisions.
These provisions are designated Compatibility Category D
because they do not meet any of the criteria of Category A,
B, or C. A State may adopt similar provisions that are compatible with the orderly pattern of regulation established by
the Atomic Energy Act, as amended (Act) and are consistent with their regulatory authority. Those portions of the
provision that address areas reserved to the NRC, e.g., 10
CFR Part 52, are designated as a Compatibility Category
NRC. A State should not adopt provisions that would confer
regulatory authority to the State in an area of exclusive
NRC jurisdiction pursuant to the Act, 10 CFR 8.4, 10 CFR
Part 150, and other Federal laws, regulations, or provisions.
These provisions are designated Compatibility Category D
because they do not meet any of the criteria of Category A,
B, or C. A State may adopt similar provisions that are compatible with the orderly pattern of regulation established by
the Atomic Energy Act, as amended (Act) and are consistent with their regulatory authority. Those portions of the
provision that address areas reserved to the NRC, e.g., 10
CFR Part 52, are designated as a Compatibility Category
NRC. A State should not adopt provisions that would confer
regulatory authority to the State in an area of exclusive
NRC jurisdiction pursuant to the Act, 10 CFR 8.4, 10 CFR
Part 150, and other Federal laws, regulations, or provisions.
This provision is designated Compatibility Category NRC because it addresses an area reserved to the NRC. A State
should not adopt provisions that would confer regulatory
authority to the State in an area of exclusive NRC jurisdiction pursuant to the Atomic Energy Act, 10 CFR 8.4, 10
CFR Part 150, and other Federal laws, regulations, or provisions.
This provision is designated Compatibility Category NRC because it addresses an area reserved to the NRC. A State
should not adopt provisions that would confer regulatory
authority to the State in an area of exclusive NRC jurisdiction pursuant to the Atomic Energy Act, 10 CFR 8.4, 10
CFR Part 150, and other Federal laws, regulations, or provisions.
This provision is designated Compatibility Category NRC because it addresses an area reserved to the NRC. A State
should not adopt provisions that would confer regulatory
authority to the State in an area of exclusive NRC jurisdiction pursuant to the Atomic Energy Act, 10 CFR 8.4, 10
CFR Part 150, and other Federal laws, regulations, or provisions.
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49463
LIST OF CHANGES 10 CFR PART 52 FINAL RULEMAKING—Continued
Description new,
changes
Sections
Compatibility designation
Comments regarding compatibility designation
This provision is designated a Compatibility Category NRC
because it addresses an area reserved to the NRC. A
State should not adopt provisions that would confer regulatory authority to the State in an area of exclusive NRC jurisdiction pursuant to the Atomic Energy Act, 10 CFR 8.4,
10 CFR Part 150, and other Federal laws, regulations, or
provisions.
This provision is designated Compatibility Category NRC because it addresses an area reserved to the NRC. A State
should not adopt provisions that would confer regulatory
authority to the State in an area of exclusive NRC jurisdiction pursuant to the Atomic Energy Act, 10 CFR 8.4, 10
CFR Part 150, and other Federal laws, regulations, or provisions.
This provision is designated Compatibility Category NRC because it addresses an area reserved to the NRC. A State
should not adopt provisions that would confer regulatory
authority to the State in an area of exclusive NRC jurisdiction pursuant to the Atomic Energy Act, 10 CFR 8.4, 10
CFR Part 150, and other Federal laws, regulations, or provisions.
2.817 .........................
Withdrawal of application.
NRC ...............................
2.819 .........................
Denial of application for
failure to supply information.
NRC ...............................
2.1202 .......................
Authority and role of
NRC staff.
NRC ...............................
Criteria and procedures
for determining eligibility for access to restricted data or national security information or an employment
clearance.
NRC for all sections ......
These provisions are designated Compatibility Category NRC
because they address areas reserved to the NRC. A State
should not adopt provisions that would confer regulatory
authority to the State in an area of exclusive NRC jurisdiction pursuant to the Atomic Energy Act, 10 CFR 8.4, 10
CFR Part 150, and other Federal laws, regulations, or provisions.
10 CFR Part 19—Notices,
Instructions and Reports to Workers: Inspection and Investigations
19.1 ...........................
Purpose .........................
D ....................................
19.2 ...........................
Scope ............................
D, except portions of the
provisions in (a)(1),
(a)(2), (a)(3), and
(a)(4) are designated
as NRC.
19.3—Definitions ......
License ..........................
D, except portions of the
definition are NRC.
This provision is designated Category D because it does not
meet any of the criteria of Category A, B, or C. A State
may adopt a similar provision that is compatible with the orderly pattern of regulation established by the Atomic Energy Act, as amended (Act) and are consistent with their
regulatory authority.
This provision is designated Compatibility Category D because it does not meet any of the criteria of Category A, B,
or C. A State may adopt similar provisions that are compatible with the orderly pattern of regulation established by the
Atomic Energy Act, as amended (Act) and are consistent
with their regulatory authority. Those portions of the provision that address areas reserved to the NRC, e.g., 10 CFR
Parts 50, 51, 52, 53, 54, 60, 63, 72, and 76, are designated
as a Compatibility Category NRC. A State should not adopt
provisions that would confer regulatory authority to the
State in an area of exclusive NRC jurisdiction pursuant to
the Act, 10 CFR 8.4, 10 CFR Part 150, and other Federal
laws, regulations, or provisions.
This definition is designated Category D because it does not
meet any of the criteria of Category A, B, or C. A State
may adopt a similar definition that is compatible with the orderly pattern of regulation established by the Atomic Energy Act, as amended (Act) and is consistent with their regulatory authority. Those portions of the definition that address areas reserved to the NRC, e.g., 10 CFR Parts 50,
51, 52, 53, 54, 55, 60, 63, 72, 73, and 76, are designated
as a Compatibility Category NRC. A State should not adopt
provisions that would confer regulatory authority to the
State in an area of exclusive NRC jurisdiction pursuant to
the Atomic Energy Act, 10 CFR 8.4, 10 CFR Part 150, and
other Federal laws, regulations, or provisions. This definition appears in 10 CFR 20.1003. For purposes of compatibility, States should use the language of the Part 20 definition, which is assigned a Compatibility Category D.
rwilkins on PROD1PC63 with RULES2
2.1211—[Removed]..
10 CFR Part 10 ...............
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LIST OF CHANGES 10 CFR PART 52 FINAL RULEMAKING—Continued
Description new,
changes
Compatibility designation
Comments regarding compatibility designation
Regulated activities .......
D ....................................
Regulated entities ..........
D, except portions of the
definition are NRC.
Worker ...........................
C ....................................
19.11 .........................
Posting of Notices to
workers.
C, except portions of
paragraph (a), and all
of paragraphs (b) and
(e) are designated as
NRC.
19.14 .........................
Presence of representatives of licensees and
workers during inspections.
C, except paragraph (a)
is designated as NRC.
19.20 .........................
Employee protection ......
D, except portions of the
provision are NRC.
This definition is designated Category D because it does not
meet any of the criteria of Category A, B, or C. A State
may adopt a similar definition that is compatible with the orderly pattern of regulation established by the Atomic Energy Act, as amended (Act) and is consistent with their regulatory authority.
This definition is designated Category D because it does not
meet any of the criteria of Category A, B, or C. A State
may adopt a similar definition that is compatible with the orderly pattern of regulation established by the Atomic Energy Act, as amended (Act) and is consistent with their regulatory authority. Those portions of the definition that address areas reserved to the NRC are designated Compatibility Category NRC. A State should not adopt provisions
that would confer regulatory authority to the State in an
area of exclusive NRC jurisdiction pursuant to the Atomic
Energy Act, 10 CFR 8.4, 10 CFR Part 150, and other Federal laws, regulations, or provisions.
This definition is designated Compatibility Category C because of its role in effective communication, dose monitoring, and commerce (transboundary). A State should
adopt definitions that are compatible with the orderly pattern of regulation established by the Atomic Energy Act, as
amended (Act) and are consistent with their regulatory authority. The essential objectives of this definition should be
adopted.
This provision is designated Compatibility Category C because it is needed to provide a minimum level of information to workers and to assure that this information is consistent from one jurisdiction to another since workers may
work in multiple jurisdictions. A State should adopt provisions that are compatible with the orderly pattern of regulation established by the Atomic Energy Act, as amended
(Act) and are consistent with their regulatory authority. The
essential objectives of this definition should be adopted.
Those portions of paragraph (a) that reference 10 CFR Part
52 activities, and paragraphs (b) and (e) address areas reserved to the NRC, and are designated Compatibility Category NRC. A State should not adopt provisions that would
confer regulatory authority to the State in an area of exclusive NRC jurisdiction pursuant to the Act, 10 CFR 8.4, 10
CFR Part 150, and other Federal laws, regulations, or provisions.
This provision is designated Compatibility Category C because it is needed to provide a minimum level of consistency from one jurisdiction to another since workers may
work in multiple jurisdictions. A State should adopt provisions that are compatible with the orderly pattern of regulation established by the Atomic Energy Act, as amended
(Act) and are consistent with their regulatory authority.
Paragraph (a) addresses areas reserved to the NRC, and
is designated Compatibility Category NRC. A State should
not adopt provisions that would confer regulatory authority
to the State in an area of exclusive NRC jurisdiction pursuant to the Act, 10 CFR 8.4, 10 CFR Part 150, and other
Federal laws, regulations, or provisions.
This provision is designated Compatibility Category D because it does not meet any of the criteria of Category A, B,
or C. A State may adopt provisions that are compatible with
the orderly pattern of regulation established by the Atomic
Energy Act, as amended (Act) and are consistent with their
regulatory authority. Those portions of the provision that
address areas reserved to the NRC, e.g., 10 CFR Parts 50,
52, 54, 60, 63, 72, and 76, are designated as a Compatibility Category NRC. A State should not adopt provisions
that would confer regulatory authority to the State in an
area of exclusive NRC jurisdiction pursuant to the Act, 10
CFR 8.4, 10 CFR Part 150, and other Federal laws, regulations, or provisions.
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Sections
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49465
LIST OF CHANGES 10 CFR PART 52 FINAL RULEMAKING—Continued
Description new,
changes
Sections
Compatibility designation
Comments regarding compatibility designation
This provision is designated Category D because it does not
meet any of the criteria of Category A, B, or C. A State
may adopt provisions that are compatible with the orderly
pattern of regulation established by the Atomic Energy Act,
as amended (Act) and are consistent with their regulatory
authority.
This provision is designated Category D because it does not
meet any of the criteria of Category A, B, or C. A State
may adopt provisions that are compatible with the orderly
pattern of regulation established by the Atomic Energy Act,
as amended (Act) and are consistent with their regulatory
authority.
Application for exemptions.
D ....................................
19.32 .........................
Discrimination prohibited
D ....................................
10 CFR Part 20—Standards of Protection
20.1002 .....................
Scope ............................
D, except portions of the
provision are designated as NRC.
20.1401 .....................
General provisions and
scope.
C, except portions of the
provision are designated as NRC.
20.1406 .....................
rwilkins on PROD1PC63 with RULES2
19.31 .........................
Minimization of contamination.
C, except portions of
paragraph (a) and all
of paragraph (b) are
designated as NRC.
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This provision is designated Compatibility Category D because it does not meet any of the criteria of Category A, B,
or C. A State may adopt provisions that are compatible with
the orderly pattern of regulation established by the Atomic
Energy Act, as amended (Act) and are consistent with their
regulatory authority. Those portions of the provision that
address areas reserved to the NRC, e.g., 10 CFR Parts 50,
52, 54, 60, 63, 72, and 76, are designated as a Compatibility Category NRC. A State should not adopt provisions
that would confer regulatory authority to the State in an
area of exclusive NRC jurisdiction pursuant to the Act, 10
CFR 8.4, 10 CFR Part 150, and other Federal laws, regulations, or provisions.
This provision is designated Compatibility Category C because it is needed to provide a minimum level of consistency regarding decommissioning activities. A State should
adopt provisions that are compatible with the orderly pattern of regulation established by the Atomic Energy Act, as
amended (Act) and are consistent with their regulatory authority. The essential objectives of these provisions should
be adopted by States. Those portions of the provision that
address areas reserved to the NRC, e.g., 10 CFR Parts 50,
52, 54, 60, 63, and 72, are designated as a Compatibility
Category NRC. A State should not adopt provisions that
would confer regulatory authority to the State in an area of
exclusive NRC jurisdiction pursuant to the Act, 10 CFR 8.4,
10 CFR Part 150, and other Federal laws, regulations, or
provisions.
This provision is designated Compatibility Category C because it is needed to provide a minimum level of safety regarding decommissioning activities. A State should adopt
provisions that are compatible with the orderly pattern of
regulation established by the Atomic Energy Act, as
amended (Act) and are consistent with their regulatory authority. The essential objectives of these provisions should
be adopted by States. Those portions of paragraph (a) that
reference 10 CFR Part 52 activities, and paragraphs (b) address areas reserved to the NRC, and are designated
Compatibility Category NRC. A State should not adopt provisions that would confer regulatory authority to the State in
an area of exclusive NRC jurisdiction pursuant to the Act,
10 CFR 8.4, 10 CFR Part 150, and other Federal laws, regulations, or provisions.
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LIST OF CHANGES 10 CFR PART 52 FINAL RULEMAKING—Continued
Description new,
changes
Sections
Compatibility designation
Comments regarding compatibility designation
Paragraphs (a) and (b) are designated Compatibility Category
C, because they are needed to provide a common understanding in collecting and reporting information on the regulation of agreement material on a nationwide basis. A State
should adopt provisions that are compatible with the orderly
pattern of regulation established by the Atomic Energy Act,
as amended (Act) and are consistent with their regulatory
authority. The essential objectives of these provisions
should be adopted by States. Paragraphs (c) and (d) address NRC exclusive areas of authority are designated
Compatibility Category NRC, and should not be adopted by
States. A State should not adopt provisions that would confer regulatory authority to the State in an area of exclusive
NRC jurisdiction pursuant to the Act, 10 CFR 8.4, 10 CFR
Part 150, and other Federal laws, regulations, or provisions.
The provisions in Part 21 are derived from statutory authority
in the Energy Reorganization Act, not the Atomic Energy
Act, which does not apply to Agreement States. Therefore,
this part cannot be addressed under either compatibility or
adequacy. While it may be argued that there are health and
safety reasons to require States to adopt the provisions of
Part 21, States may not have the statutory authority to do
so. States that have the statutory authority to implement
provisions similar to those in Part 21 may adopt similar provisions consistent with their regulatory authority but should
not address areas of exclusive NRC jurisdiction.
These provisions are designated a Compatibility Category
NRC because they address areas reserved to the NRC. A
State should not adopt provisions that would confer regulatory authority to the State in an area of exclusive NRC jurisdiction pursuant to the Atomic Energy Act, 10 CFR 8.4,
10 CFR Part 150, and other Federal laws, regulations, or
provisions.
These provisions are designated a Compatibility Category
NRC because they address areas reserved to the NRC. A
State should not adopt provisions that would confer regulatory authority to the State in an area of exclusive NRC jurisdiction pursuant to the Atomic Energy Act, 10 CFR 8.4,
10 CFR Part 150, and other Federal laws, regulations, or
provisions.
These provisions are designated a Compatibility Category
NRC because they address areas reserved to the NRC. A
State should not adopt provisions that would confer regulatory authority to the State in an area of exclusive NRC jurisdiction pursuant to the Atomic Energy Act, 10 CFR 8.4,
10 CFR Part 150, and other Federal laws, regulations, or
provisions.
These provisions are designated a Compatibility Category
NRC because they address areas reserved to the NRC. A
State should not adopt provisions that would confer regulatory authority to the State in an area of exclusive NRC jurisdiction pursuant to the Atomic Energy Act, 10 CFR 8.4,
10 CFR Part 150, and other Federal laws, regulations, or
provisions.
These provisions are designated a Compatibility Category
NRC because they address areas reserved to the NRC. A
State should not adopt provisions that would confer regulatory authority to the State in an area of exclusive NRC jurisdiction pursuant to the Atomic Energy Act, 10 CFR 8.4,
10 CFR Part 150, and other Federal laws, regulations, or
provisions.
These provisions are designated a Compatibility Category
NRC because they address areas reserved to the NRC. A
State should not adopt provisions that would confer regulatory authority to the State in an area of exclusive NRC jurisdiction pursuant to the Atomic Energy Act, 10 CFR 8.4,
10 CFR Part 150, and other Federal laws, regulations, or
provisions.
Reports of exposures,
etc., exceeding the
limits.
C paragraphs (a) and
(b).
NRC paragraphs (c) and
(d).
10 CFR Part 21 ...............
Reporting of Defects
and Noncompliance.
Not applicable for all
sections.
10 CFR Part 25 ...............
Access Authorization .....
NRC for all sections ......
10 CFR Part 26 ...............
Fitness for Duty Programs.
NRC for all sections ......
10 CFR Part 50 ...............
Domestic Licensing of
Production and Utilization Facilities.
NRC for all sections ......
10 CFR Part 51 ...............
Environmental Protection Regulation for Domestic Licensing and
Related Regulatory
Functions.
NRC for all sections ......
10 CFR Part 52 ...............
Licenses, Certifications,
and Approvals For
Nuclear Power Plants.
NRC for all sections ......
10 CFR Part 54 ...............
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20.2203 .....................
Requirements for Renewal of Operating License for Nuclear
Power Plants.
NRC for all sections ......
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Federal Register / Vol. 72, No. 166 / Tuesday, August 28, 2007 / Rules and Regulations
49467
LIST OF CHANGES 10 CFR PART 52 FINAL RULEMAKING—Continued
Sections
Description new,
changes
Compatibility designation
Comments regarding compatibility designation
10 CFR Part 55 ...............
Operators License .........
NRC for all sections ......
10 CFR Part 72 ...............
Licensing Requirements
for Independent Storage of Spent Nuclear
Fuel and High-level
Radioactive Waste
and Greater than
Class C.
Physical Protection of
Plants and Materials.
NRC for all sections ......
10 CFR Part 75 ...............
Safeguards on Nuclear
Material—Implementation of US/IAEA
Agreement.
NRC for all sections ......
10 CFR Part 95 ...............
Facility Security Clearance and Safeguarding of National
Security Information
and Restricted Data.
NRC for all sections ......
10 CFR Part 140 .............
Financial Protection Requirements and Indemnity Agreements.
NRC for all sections ......
10 CFR Part 170 .............
Fees for Facilities, Materials, Import and Export Licenses, and
Other Regulatory
Services under the
Atomic Energy Act of
1954, as Amended.
Annual Fees: For Reactor Licenses and Fuel
Cycle Licenses and
Material Licenses, Including Holders of
Certificates of Compliance, Registrations,
and Quality Assurance
Program Approvals
and Government
Agencies Licensed by
NRC.
D ....................................
These provisions are designated a Compatibility Category
NRC because they address areas reserved to the NRC. A
State should not adopt provisions that would confer regulatory authority to the State in an area of exclusive NRC jurisdiction pursuant to the Atomic Energy Act, 10 CFR 8.4,
10 CFR Part 150, and other Federal laws, regulations, or
provisions.
These provisions are designated a Compatibility Category
NRC because they address areas reserved to the NRC. A
State should not adopt provisions that would confer regulatory authority to the State in an area of exclusive NRC jurisdiction pursuant to the Atomic Energy Act, 10 CFR 8.4,
10 CFR Part 150, and other Federal laws, regulations, or
provisions.
These provisions are designated a Compatibility Category
NRC because they address areas reserved to the NRC. A
State should not adopt provisions that would confer regulatory authority to the State in an area of exclusive NRC jurisdiction pursuant to the Atomic Energy Act, 10 CFR 8.4,
10 CFR Part 150, and other Federal laws, regulations, or
provisions.
These provisions are designated a Compatibility Category
NRC because they address areas reserved to the NRC. A
State should not adopt provisions that would confer regulatory authority to the State in an area of exclusive NRC jurisdiction pursuant to the Atomic Energy Act, 10 CFR 8.4,
10 CFR Part 150, and other Federal laws, regulations, or
provisions.
These provisions are designated a Compatibility Category
NRC because they address areas reserved to the NRC. A
State should not adopt provisions that would confer regulatory authority to the State in an area of exclusive NRC jurisdiction pursuant to the Atomic Energy Act, 10 CFR 8.4,
10 CFR Part 150, and other Federal laws, regulations, or
provisions.
These provisions are designated a Compatibility Category
NRC because they address areas reserved to the NRC. A
State should not adopt provisions that would confer regulatory authority to the State in an area of exclusive NRC jurisdiction pursuant to the Atomic Energy Act, 10 CFR 8.4,
10 CFR Part 150, and other Federal laws, regulations, or
provisions.
These provisions are designated a Category D because they
do not meet any of the criteria of Category A, B, or C. A
State may adopt similar provisions that are compatible with
the orderly pattern of regulation established by the Atomic
Energy Act, as amended (Act) and are consistent with their
regulatory authority.
10 CFR Part 73 ...............
10 CFR Part 171 .............
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IX. Voluntary Consensus Standards
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
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NRC for all sections ......
D ....................................
These provisions are designated a Category D because they
do not meet any of the criteria of Category A, B, or C. A
State may adopt similar provisions that are compatible with
the orderly pattern of regulation established by the Atomic
Energy Act, as amended (Act) and are consistent with their
regulatory authority.
consensus standards bodies unless
using such a standard is inconsistent
with applicable law or is otherwise
impractical. In this rule, the NRC is
revising the procedural requirements for
early site permits, standard design
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approvals, standard design
certifications, combined licenses, and
manufacturing licenses to make certain
corrections and changes based on the
experience of the previous design
certification reviews and on discussions
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with stakeholders on these licensing
processes. These procedural
requirements for rulemaking do not
establish standards or substantive
requirements with which all applicants
and licensees must comply. In addition,
portions of this rulemaking make
conforming changes to regulatory
requirements throughout 10 CFR
Chapter I, such as access to national
security information and the procedures
governing the conduct of hearings in
proceedings. These changes also do not
establish standards or substantive
requirements with which all applicants
and licensees must comply. Finally,
portions of this rulemaking make
conforming changes to technical
requirements throughout 10 CFR
Chapter I, in order to make clear their
applicability to applicants and licensees
under part 52. Inasmuch as the purpose
of this rulemaking was not to establish
or fundamentally alter these technical
requirements, the Commission
considers it impractical to perform a
reassessment of the fundamental nature
of these technical requirements in this
rulemaking. In addition, this rule
amends certain portions of the three
design certification regulations in 10
CFR part 52, appendices A, B, and C (for
U.S. ABWR, System 80+, and AP600
designs, respectively). Design
certifications are not generic
rulemakings in the sense that design
certifications do not establish standards
or requirements with which all
applicants and licensees must comply.
Rather, design certifications are
Commission approvals of specific
nuclear power plant designs by
rulemaking. Furthermore, design
certification rulemakings are initiated
by an applicant for a design
certification, rather than the NRC. For
these reasons, the Commission
concludes that this action does not
constitute the establishment of a
standard that contains generally
applicable requirements.
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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 10 CFR 51.22(c)(1), (c)(2),
and (c)(3). Therefore, neither an
environmental impact statement nor an
environmental assessment has been
prepared for this regulation.19
19 When 10 CFR part 52 was issued in 1989, the
NRC determined that the regulation met the
eligibility criteria for the categorical exclusion set
forth in 10 CFR 51.22(c)(3). As stated in the Federal
Register notice for the final rule (54 FR 15384; April
18, 1989), ‘‘It makes no substantive difference for
the purpose of the categorical exclusion that the
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XI. Paperwork Reduction Act
Statement
This final rule contains new or
amended information collection
requirements contained in 10 CFR parts
21, 25, 50, 51, 52, and 54 that are subject
to the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.). These
requirements were approved by the
Office of Management and Budget
approval numbers 3150–0035, 3150–
0046, 3150–0011, 3150–0021, 3150–
0151, and 3150–0155. The changes to 10
CFR parts 19, 20, 26, 55, 72, 73, 75, 95,
and 140 do not contain new or amended
information collection requirements.
Existing requirements were approved by
the Office of Management and Budget,
approval numbers 3150–0044, 3150–
0014, 3150–0146, 3150–0018, 3150–
0132, 3150–0002, 3150–0055, 3150–
0047, and 3150–0039.
The burden to the public for the
information collections in 10 CFR part
52 is estimated to average 11,277 hours
per response. This includes the time for
reviewing instructions, searching
existing data sources, gathering and
maintaining the data needed, and
completing and reviewing the
information collection. Send comments
on any aspect of these information
collections, including suggestions for
reducing the burden to the records and
FOIA/Privacy Services Branch (T–5 F53,
U.S. Nuclear Regulatory Commission,
Washington, DC 20555–0001), or by
Internet electronic mail to
INFOCOLLECTS@NRC.GOV; and to the
Desk Officer, Office of Information and
Regulatory Affairs, NEOB–10202 (3150–
0035, 3150–0046, 3150–0011, 3150–
0151, and 3150–0155 with revised
information collection requirements),
Office of Management and Budget,
Washington, DC 20503.
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
regulatory analysis on this final rule.
amendments are in a new 10 CFR part 52 rather
than in 10 CFR part 50. The amendments are, in
fact, amendments to the 10 CFR part 50 procedures
and could have been placed in that part.’’ The
categorical exclusion for the current proposed
change to 10 CFR part 52 is consistent with the
original categorical exclusion determination. To
ensure that future changes in part 52 are
categorically excluded, this rule contains an
appropriate change to § 51.22(c)(3).
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Consistent with the Regulatory Analysis
Guidelines, the NRC performed an
aggregate analysis of the rule. The
analysis is based on the assumption that
the NRC will receive 19 COL
applications during the next 3 years and
1 COL application per year over the next
17 years. The net present value of the
part 52 rule modifications are estimated
to result in costs to the industry of
$58,992 K and $30,952 K using a 3percent and a 7-percent discount rate,
respectively. The provisions of the rule
relating to part 21 are estimated to result
in net present value costs of $3,873 K
and $2,363 K to the industry, using a 3percent and a 7-percent discount rate,
respectively. The net present value of
the entire rule is estimated to result in
net costs to the industry of $29,726 K
and $204 K at a 3-percent and a 7percent discount rate, respectively. In
addition, the rule is estimated to be a
one time net present value savings to
the NRC of $10,443 K.
XIII. Regulatory Flexibility
Certification
In accordance with the Regulatory
Flexibility Act (5 U.S.C. 605(b)), the
Commission certifies that this rule will
not have a significant economic impact
on a substantial number of small
entities. This rule affects only the
licensing of nuclear power plants. The
companies that will apply for an
approval, certification, permit, site
report, or license in accordance with the
regulations affected by this rule 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. Backfit Analysis
The NRC has determined that the
backfit rule does not apply to this rule
and, therefore, a backfit analysis is not
required, because the rule does not
contain any provisions that would
impose backfitting as defined in the
backfit rule, 10 CFR 50.109.
There are no current holders of
combined licenses or manufacturing
licenses that are protected by the
backfitting restrictions in §§ 50.109,
52.39, 52.98, or 52.171. To the extent
that this rule revises the requirements
for future early site permits, standard
design certifications, combined licenses,
standard design approvals and
manufacturing licenses for nuclear
power plants, these revisions do not
constitute backfits because they are
prospective in nature and the backfit
rule is not intended to apply to every
NRC action which substantially changes
the expectations of future applicants.
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Federal Register / Vol. 72, No. 166 / Tuesday, August 28, 2007 / Rules and Regulations
49469
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.
The NRC issued the first early site
permits prior to the effective date of this
final part 52 rule. In addition, there are
applications for early site permits
currently being considered by the NRC.
As discussed elsewhere, the NRC has
included a ‘‘grandfathering provision’’
in the final part 52 rulemaking which
provides that the early site permit
provisions in subpart A of part 52 do
not apply to early site permits whose
applications were docketed before the
effective date of the final part 52
rulemaking, unless requested by the
early site permit applicant. This
grandfathering provision prohibits any
backfitting for these early site permits.
Other provisions in this rule would
apply to currently-approved standard
design approvals and certifications, but
they are not protected by the backfitting
restrictions in § 50.104 or § 52.63
because they are either corrections,
administrative changes, or provide
additional flexibility to applicants or
licensees who might reference the
design approvals or certifications, and
thus constitute a voluntary alternative
or relaxation.
Finally, some of the provisions in this
rule represent conforming changes
throughout 10 CFR Chapter I which are
being made to reflect Commission
adoption of design approvals and design
certification processes which should
have been made at the time the
Commission first adopted these
processes by rulemaking. While these
conforming changes may, in some cases,
affect the way in which a current design
certification or design approval may be
referenced, they do not directly affect
the design approval nor are the
conforming changes result in any
inconsistency with the finality
provisions in the design certifications or
in part 52. Accordingly, the Commission
believes that these conforming changes
with respect to design approvals and
design certifications do not raise new
backfitting considerations.
material, Classified information,
Environmental protection, Nuclear
materials, Nuclear power plants and
reactors, Penalties, Sex discrimination,
Source material, Special nuclear
material, Waste treatment and disposal.
XV. Congressional Review Act
10 CFR Part 50
Under the Congressional Review Act
of 1996, the NRC has determined that
this action is not a major rule and has
verified this determination with the
Office of Information and Regulatory
Affairs of OMB.
10 CFR Part 95
Antitrust, Classified information,
Criminal penalties, Emergency
Planning, Fire protection,
Intergovernmental relations, Nuclear
power plants and reactors, Radiation
protection, Reactor siting criteria,
Reporting and recordkeeping
requirements.
Classified information, Criminal
penalties, Reporting and recordkeeping
requirements, Security measures.
List of Subjects
rwilkins on PROD1PC63 with RULES2
10 CFR Part 1
Organization and functions
(Government Agencies).
10 CFR Part 2
Administrative practice and
procedure, Antitrust, Byproduct
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17:54 Aug 27, 2007
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10 CFR Part 10
Administrative practice and
procedure, Classified information,
Government employees, Security
measures.
10 CFR Part 19
Criminal penalties, Environmental
protection, Nuclear materials, Nuclear
power plants and reactors, Occupational
safety and health, Radiation protection,
Reporting and recordkeeping
requirements, Sex discrimination.
10 CFR Part 20
Byproduct material, Criminal
penalties, Licensed material, Nuclear
materials, Nuclear power plants and
reactors, Occupational safety and
health, Packaging and containers,
Radiation protection, Reporting and
recordkeeping requirements, Source
material, Special nuclear material,
Waste treatment and disposal.
10 CFR Part 54
Administrative practice and
procedure, Age-related degradation,
Backfitting, Classified information,
Criminal penalties, Environmental
protection, Nuclear power plants and
reactors, Reporting and recordkeeping
requirements.
10 CFR Part 55
Criminal penalties, Manpower
training programs, Nuclear power plants
and reactors, Reporting and
recordkeeping requirements.
Nuclear power plants and reactors,
Penalties, Radiation protection,
Reporting and recordkeeping
requirements.
10 CFR Part 72
Administrative practice and
procedure, Criminal penalties,
Manpower training programs, Nuclear
materials, Occupational safety and
health, Penalties, Radiation protection,
Reporting and recordkeeping
requirements, Security measures, Spent
fuel, Whistleblowing.
10 CFR Part 25
10 CFR Part 73
Classified information, Criminal
penalties, Investigations, Reporting and
recordkeeping requirements, Security
measures.
Criminal penalties, Export, Hazardous
materials transportation, Import,
Nuclear materials, Nuclear power plants
and reactors, Reporting and
recordkeeping requirements, Security
measures.
10 CFR Part 21
10 CFR Part 26
Alcohol abuse, Alcohol testing,
Appeals, Chemical testing, Drug abuse,
Drug testing, Employee assistance
programs, Fitness for duty, Management
actions, Nuclear power reactors,
Protection of information, Reporting and
recordkeeping requirements.
10 CFR Part 51
Administrative practice and
procedure, Environmental impact
statement, Nuclear materials, Nuclear
power plants and reactors, Reporting
and recordkeeping requirements.
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10 CFR Part 75
Criminal penalties, Intergovernmental
relations, Nuclear materials, Nuclear
power plants and reactors, Reporting
and recordkeeping requirements,
Security measures.
10 CFR Part 140
Criminal penalties, Extraordinary
nuclear occurrence, Insurance,
Intergovernmental relations, Nuclear
materials, Nuclear power plants and
reactors, Reporting and recordkeeping
requirements.
10 CFR Part 170
Byproduct material, Import and
export licenses, Intergovernmental
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relations, Non-payment penalties,
Nuclear materials, Nuclear power plants
and reactors, Source material, Special
nuclear material.
10 CFR Part 171
Nuclear power plants and reactors.
I For the reasons set forth 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. 552 and 553,
the NRC is adopting the following
amendments to 10 CFR parts 1, 2, 10,
19, 20, 21, 25, 26, 50, 51, 52, 54, 55, 72,
73, 75, 95, 140, 170, and 171.
PART 1—STATEMENT OF
ORGANIZATION AND GENERAL
INFORMATION
1. The authority citation for part 1
continues to read as follows:
I
Authority: Secs. 23, 161, 68 Stat. 925, 948,
as amended (42 U.S.C. 2033, 2201); sec. 29,
Pub. L. 85–256, 71 Stat. 579, Pub. L. 95–209,
91 Stat. 1483 (42 U.S.C. 2039); sec. 191, Pub.
L. 87–615, 76 Stat. 409 (42 U.S.C. 2241); secs.
201, 203, 204, 205, 209, 88 Stat. 1242, 1244,
1245, 1246, 1248, as amended (42 U.S.C.
5841, 5843, 5844, 5845, 5849); 5 U.S.C. 552,
553; Reorganization Plan No. 1 of 1980, 45
FR 40561, June 16, 1980.
2134, 2135, 2233, 2239). Sections 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. 161 b, 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).
Sections 2.600–2.606 also issued under sec.
102, Pub. L. 91–190, 83 Stat. 853, as amended
(42 U.S.C. 4332). Section 2.700a also issued
under 5 U.S.C. 554. Sections 2.343, 2.346,
2.754, 2.712 also issued under 5 U.S.C. 557.
Section 2.764 also issued under secs. 135,
141, Pub. L. 97–425, 96 Stat. 2232, 2241 (42
U.S.C. 10155, 10161). Section 3.790 also
issued under sec. 103, 68 Stat. 936, as
amended (42 U.S.C. 2133), and 5 U.S.C. 552.
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).
an application for a license or permit
has been granted or is pending before
the Commission.
*
*
*
*
*
License means a license, including an
early site permit, construction permit,
operating license, combined license,
manufacturing license, or renewed
license issued by the Commission.
Licensee means a person who is
authorized to conduct activities under a
license.
*
*
*
*
*
I 6. The heading of Subpart A is revised
to read as follows:
Subpart A—Procedure for Issuance,
Amendment, Transfer, or Renewal of a
License, and Standard Design
Approval
7. Section 2.100 is revised to read as
follows:
I
§ 2.100
Scope of subpart.
§ 1.43 Office of Nuclear Reactor
Regulation.
4. In § 2.1, paragraphs (c) and (d) are
revised and a new paragraph (e) is
added to read as follows:
This subpart prescribes the procedure
for issuance of a license; amendment of
a license at the request of the licensee;
transfer and renewal of a license; and
issuance of a standard design approval
under subpart E of part 52 of this
chapter.
I 8. In § 2.101, paragraphs (a)(1), (a)(2),
the introductory paragraph of (a)(3),
paragraph (a)(3)(ii), paragraph (a)(4),
paragraph (a)(5), and paragraph (a–1) are
revised to read as follows:
*
§ 2.1
§ 2.101
2. In § 1.43, paragraph (a)(2) is revised
to read as follows:
I
*
*
*
*
(a) * * *
(2) Receipt, possession, and
ownership of source, byproduct, and
special nuclear material used or
produced at facilities licensed under 10
CFR parts 50, 52, and 54;
*
*
*
*
*
PART 2—RULES OF PRACTICE FOR
DOMESTIC LICENSING PROCEEDINGS
AND ISSUANCE OF ORDERS
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*
*
*
*
(c) Imposing civil penalties under
Section 234 of the Act;
(d) Rulemaking under the Act and the
Administrative Procedure Act; and
(e) Standard design approvals under
part 52 of this chapter.
I 5. In § 2.4, the definitions of contested
proceeding, license and licensee are
revised to read as follows:
Definitions.
*
Authority: Secs. 161, 181, 68 Stat. 948,
953, as amended (42 U.S.C. 2201, 2231); sec.
191, as amended, Pub. L. 87–615, 76 Stat. 409
(42 U.S.C. 2241); sec. 201, 88 Stat. 1242, as
amended (42 U.S.C. 5841); 5 U.S.C. 552; sec.
1704, 112 Stat. 2750 (44 U.S.C. 3504 note).
Section 2.101 also issued under secs. 53,
62, 63, 81, 103, 104, 105, 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(o)), 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, 2.721 also issued under secs. 102, 104,
105, 163, 183i, 189, 68 Stat. 936, 937, 938,
954, 955, as amended (42 U.S.C. 2132, 2133,
17:54 Aug 27, 2007
Scope.
*
§ 2.4
3. The authority citation for part 2
continues to read as follows:
I
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I
*
*
*
*
Contested proceeding means—
(1) A proceeding in which there is a
controversy between the NRC staff and
the applicant for a license or permit
concerning the issuance of the license or
permit or any of the terms or conditions
thereof;
(2) A proceeding in which the NRC is
imposing a civil penalty or other
enforcement action, and the subject of
the civil penalty or enforcement action
is an applicant for or holder of a license
or permit, or is or was an applicant for
a standard design certification under
part 52 of this chapter; and
(3) A proceeding in which a petition
for leave to intervene in opposition to
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Filing of application.
(a)(1) An application for a permit, a
license, a license transfer, a license
amendment, a license renewal, or a
standard design approval, shall be filed
with the Director of New Reactors or
Director of Nuclear Reactor Regulation
or Director of Nuclear Material Safety
and Safeguards, as prescribed by the
applicable provisions of this chapter. A
prospective applicant may confer
informally with the NRC staff before
filing an application.
(2) Each application for a license for
a facility or for receipt of waste
radioactive material from other persons
for the purpose of commercial disposal
by the waste disposal licensee will be
assigned a docket number. However, to
allow a determination as to whether an
application for a construction permit,
operating license, early site permit,
standard design approval, combined
license, or manufacturing license for a
production or utilization facility is
complete and acceptable for docketing,
it will be initially treated as a tendered
application. A copy of the tendered
application will be available for public
inspection at the NRC Web site,
https://www.nrc.gov, and/or at the NRC
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Public Document Room. Generally, the
determination on acceptability for
docketing will be made within a period
of 30 days. However, in selected
applications, the Commission may
decide to determine acceptability based
on the technical adequacy of the
application as well as its completeness.
In these cases, the Commission, under
§ 2.104(a), will direct that the notice of
hearing be issued as soon as practicable
after the application has been tendered,
and the determination of acceptability
will be made generally within a period
of 60 days. For docketing and other
requirements for applications under part
61 of this chapter, see paragraph (g) of
this section.
(3) If the Director of New Reactors,
Director of Nuclear Reactor Regulation,
or Director of Nuclear Material Safety
and Safeguards, as appropriate,
determines that a tendered application
for a construction permit, operating
license, early site permit, standard
design approval, combined license, or
manufacturing license for a production
or utilization facility, and/or any
environmental report required under
subpart A of part 51 of this chapter, or
part thereof as provided in paragraphs
(a)(5) or (a–1) of this section are
complete and acceptable for docketing,
a docket number will be assigned to the
application or part thereof, and the
applicant will be notified of the
determination. With respect to the
tendered application and/or
environmental report or part thereof that
is acceptable for docketing, the
applicant will be requested to:
*
*
*
*
*
(ii) Serve a copy on the chief
executive of the municipality in which
the facility or site which is the subject
of an early site permit is to be located
or, if the facility or site which is the
subject of an early site permit is not to
be located within a municipality, on the
chief executive of the county, and serve
a notice of availability of the application
or environmental report on the chief
executives of the municipalities or
counties which have been identified in
the application or environmental report
as the location of all or part of the
alternative sites, containing the
following information, as applicable:
Docket number of the application, a
brief description of the proposed site
and facility; the location of the site and
facility as primarily proposed and
alternatively listed; the name, address,
telephone number, and email address (if
available) of the applicant’s
representative who may be contacted for
further information; notification that a
draft environmental impact statement
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will be issued by the Commission and
will be made available upon request to
the Commission; and notification that if
a request is received from the
appropriate chief executive, the
applicant will transmit a copy of the
application and environmental report,
and any changes to these documents
which affect the alternative site
location, to the executive who makes
the request. In complying with the
requirements of this paragraph, the
applicant should not make public
distribution of those parts of the
application subject to § 2.390(d). The
applicant shall submit to the Director of
New Reactors or the Director of Nuclear
Reactor Regulation an affidavit that
service of the notice of availability of
the application or environmental report
has been completed along with a list of
names and addresses of those executives
upon whom the notice was served; and
*
*
*
*
*
(4) The tendered application for a
construction permit, operating license,
early site permit, standard design
approval, combined license, or
manufacturing license will be formally
docketed upon receipt by the Director of
New Reactors, Director of Nuclear
Reactor Regulation, or Director of
Nuclear Material Safety and Safeguards,
as appropriate, of the required
additional copies. Distribution of the
additional copies shall be deemed to be
complete as of the time the copies are
deposited in the mail or with a carrier
prepaid for delivery to the designated
addresses. The date of docketing shall
be the date when the required copies are
received by the Director of New
Reactors, Director of Nuclear Reactor
Regulation, or Director of Nuclear
Material Safety and Safeguards, as
appropriate. Within 10 days after
docketing, the applicant shall submit to
the Director of New Reactors, Director of
Nuclear Reactor Regulation, or Director
of Nuclear Material Safety and
Safeguards, as appropriate, an affidavit
that distribution of the additional copies
to Federal, State, and local officials has
been completed in accordance with the
requirements of this chapter and written
instructions furnished to the applicant
by the Director of New Reactors,
Director of Nuclear Reactor Regulation,
or Director of Nuclear Material Safety
and Safeguards, as appropriate.
Amendments to the application and
environmental report shall be filed and
distributed and an affidavit shall be
furnished to the Director of New
Reactors, Director of Nuclear Reactor
Regulation, or Director of Nuclear
Material Safety and Safeguards, as
appropriate, in the same manner as for
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the initial application and
environmental report. If it is determined
that all or any part of the tendered
application and/or environmental report
is incomplete and therefore not
acceptable for processing, the applicant
will be informed of this determination,
and the respects in which the document
is deficient.
(5) An applicant for a construction
permit under part 50 of this chapter or
a combined license under part 52 of this
chapter for a production or utilization
facility which is subject to § 51.20(b) of
this chapter, and is of the type specified
in § 50.21(b)(2) or (3) or § 50.22 of this
chapter or is a testing facility may
submit the information required of
applicants by part 50 or part 52 of the
chapter in two parts. One part shall be
accompanied by the information
required by § 50.30(f) of this chapter, or
§ 52.80(b) of this chapter, as applicable.
The other part shall include any
information required by § 50.34(a) and,
if applicable, § 50.34a of this chapter, or
§§ 52.79 and 52.80(a), as applicable.
One part may precede or follow other
parts by no longer than 6 months. If it
is determined that either of the parts as
described above is incomplete and not
acceptable for processing, the Director
of New Reactors, Director of Nuclear
Reactor Regulation, or Director of
Nuclear Material Safety and Safeguards,
as appropriate, will inform the applicant
of this determination and the respects in
which the document is deficient. Such
a determination of completeness will
generally be made within a period of 30
days. Whichever part is filed first shall
also include the fee required by
§§ 50.30(e) and 170.21 of this chapter
and the information required by
§§ 50.33, 50.34(a)(1) or 52.79(a)(1), as
applicable, and § 50.37 of this chapter.
The Director of New Reactors, Director
of Nuclear Reactor Regulation, or
Director of Nuclear Material Safety and
Safeguards, as appropriate, will accept
for docketing an application for a
construction permit under part 50 or a
combined license under part 52 for a
production or utilization facility which
is subject to § 51.20(b) of this chapter,
and is of the type specified in
§ 50.21(b)(2) or (3) or § 50.22 of this
chapter or is a testing facility where one
part of the application as described
above is complete and conforms to the
requirements of part 50 of this chapter.
The additional parts will be docketed
upon a determination by the Director of
New Reactors, Director of Nuclear
Reactor Regulation, or Director of
Nuclear Material Safety and Safeguards,
as appropriate, that it is complete.
(a–1) Early consideration of site
suitability issues. An applicant for a
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construction permit under part 50 of
this chapter or a combined license
under part 52 of this chapter for a
utilization facility which is subject to
§ 51.20(b) of this chapter and is of the
type specified in § 50.21(b)(2) or (3) or
§ 50.22 of this chapter or is a testing
facility, may request that the
Commission conduct an early review
and hearing and render an early partial
decision in accordance with subpart F
of this part on issues of site suitability
within the purview of the applicable
provisions of parts 50, 51, 52, and 100
of this chapter.
(1) Construction permit. The applicant
for the construction permit may submit
the information required of applicants
by the provisions of this chapter in three
parts:
(i) Part one shall include or be
accompanied by any information
required by §§ 50.34(a)(1) and 50.30(f) of
this chapter which relates to the issue(s)
of site suitability for which an early
review, hearing, and partial decision are
sought, except that information with
respect to operation of the facility at the
projected initial power level need not be
supplied, and shall include the
information required by §§ 50.33(a)
through (e) and 50.37 of this chapter.
The information submitted shall also
include:
(A) Proposed findings on the issues of
site suitability on which the applicant
has requested review and a statement of
the bases or the reasons for those
findings,
(B) A range of postulated facility
design and operation parameters that is
sufficient to enable the Commission to
perform the requested review of site
suitability issues under the applicable
provisions of parts 50, 51, and 100, and
(C) Information concerning the
applicant’s site selection process and
long-range plans for ultimate
development of the site required by
§ 2.603(b)(1).
(ii) Part two shall include or be
accompanied by the remaining
information required by §§ 50.30(f),
50.33, and 50.34(a)(1) of this chapter.
(iii) Part three shall include the
remaining information required by
§§ 50.34a and (in the case of a nuclear
power reactor) 50.34(a) of this chapter.
(iv) The information required for part
two or part three shall be submitted
during the period the partial decision on
part one is effective. Submittal of the
information required for part three may
precede by no more than 6 months or
follow by no more than 6 months the
submittal of the information required for
part two.
(2) Combined license under part 52.
An applicant for a combined license
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under part 52 of this chapter may
submit the information required of
applicants by the provisions of this
chapter in three parts:
(i) Part one shall include or be
accompanied by any information
required by §§ 52.79(a)(1) and 50.30(f) of
this chapter which relates to the issue(s)
of site suitability for which an early
review, hearing, and partial decision are
sought, except that information with
respect to operation of the facility at the
projected initial power level need not be
supplied, and shall include the
information required by §§ 50.33(a)
through (e) and 50.37 of this chapter.
The information submitted shall also
include:
(A) Proposed findings on the issues of
site suitability on which the applicant
has requested review and a statement of
the bases or the reasons for those
findings;
(B) A range of postulated facility
design and operation parameters that is
sufficient to enable the Commission to
perform the requested review of site
suitability issues under the applicable
provisions of parts 50, 51, 52, and 100;
and
(C) Information concerning the
applicant’s site selection process and
long-range plans for ultimate
development of the site required by
§ 2.621(b)(1).
(ii) Part two shall include or be
accompanied by the remaining
information required by §§ 50.30(f),
50.33, and 52.79(a)(1) of this chapter.
(iii) Part three shall include the
remaining information required by
§§ 52.79 and 52.80 of this chapter.
(iv) The information required for part
two or part three shall be submitted
during the period the partial decision on
part one is effective. Submittal of the
information required for part three may
precede by no more than 6 months or
follow by no more than 6 months the
submittal of the information required for
part two.
*
*
*
*
*
I 9. In § 2.102, paragraph (a) is revised
to read as follows:
§ 2.102 Administrative review of
application.
(a) During review of an application by
the NRC staff, an applicant may be
required to supply additional
information. The staff may request any
one party to the proceeding to confer
with the staff informally. In the case of
a docketed application for a
construction permit, operating license,
early site permit, standard design
approval, combined license, or
manufacturing license of this chapter,
the staff shall establish a schedule for its
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review of the application, specifying the
key intermediate steps from the time of
docketing until the completion of its
review.
*
*
*
*
*
I 10. Section 2.104 is revised to read as
follows:
§ 2.104
Notice of hearing.
(a) In the case of an application on
which a hearing is required by the Act
or this chapter, or in which the
Commission finds that a hearing is
required in the public interest, the
Secretary will issue a notice of hearing
to be published in the Federal Register.
The notice must be published at least 15
days, and in the case of an application
concerning a construction permit, early
site permit, or combined license for a
facility of the type described in
§ 50.21(b) or § 50.22 of this chapter or a
testing facility, at least 30 days before
the date set for hearing in the notice.1
In addition, in the case of an application
for a construction permit, early site
permit, or combined license for a
facility of the type described in § 50.22
of this chapter, or a testing facility, the
notice must be issued as soon as
practicable after the NRC has docketed
the application; provided, that if the
NRC decides, under § 2.101(a)(2), to
determine the acceptability of the
application based upon its technical
adequacy as well as completeness, the
notice shall be issued as soon as
practicable after the application has
been tendered.
(b) The notice of hearing must state:
(1) The nature of the hearing;
(2) The authority under which the
hearing is to be held;
(3) The matters of fact and law to be
considered;
(4) The date by which requests for
hearing or petitions to intervene must be
filed;
(5) The presiding officer designated
for the hearing, or the procedure that the
Commission will use to designate a
presiding officer for the hearing.
(c)(1) The Secretary will transmit a
notice of hearing on an application for
a license for a production or utilization
facility including an early site permit,
combined license (but not for a
manufacturing license), for a license for
1 If the notice of hearing concerning an
application for a construction permit, early site
permit, or combined license for a facility of the type
described in § 50.22 of this chapter or a testing
facility does not specify the time and place of initial
hearing, a subsequent notice will be published in
the Federal Register which will provide at least 30
days notice of the time and place of that hearing.
After this notice is given, the presiding officer may
reschedule the commencement of the initial hearing
for a later date or reconvene a recessed hearing
without again providing at least 30 days notice.
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receipt of waste radioactive material
from other persons for the purpose of
commercial disposal by the waste
disposal licensee, for a license under
part 61 of this chapter, for a
construction authorization for an HLW
repository at a geologic repository
operations area under parts 60 or 63 of
this chapter, for a license to receive and
possess high-level radioactive waste at a
geologic repository operations area
under parts 60 or 63 of this chapter, and
for a license under part 72 of this
chapter to acquire, receive or possess
spent fuel for the purpose of storage in
an independent spent fuel storage
installation (ISFSI) to the governor or
other appropriate official of the State
and to the chief executive of the
municipality in which the facility is to
be located or the activity is to be
conducted or, if the facility is not to be
located or the activity conducted within
a municipality, to the chief executive of
the county (or to the Tribal organization,
if it is to be located or conducted within
an Indian reservation).
(2) The Secretary will transmit a
notice of hearing on an application for
a license under part 72 of this chapter
to acquire, receive or possess spent fuel,
high-level radioactive waste or
radioactive material associated with
high-level radioactive waste for the
purpose of storage in a monitored
retrievable storage installation (MRS) to
the same persons who received the
notice of docketing under § 72.16(e) of
this chapter.
11. In § 2.105, the introductory text of
paragraphs (a) and (a)(4) are revised,
and paragraphs (a)(12), (a)(13), and
(b)(3) are added to read as follows:
I
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§ 2.105
Notice of proposed action.
(a) If a hearing is not required by the
Act or this chapter, and if the
Commission has not found that a
hearing is in the public interest, it will,
before acting thereon, publish in the
Federal Register, as applicable, either a
notice of intended operation under
§ 52.103(a) of this chapter and a
proposed finding that inspections, tests,
analysis, and acceptance criteria for a
combined license under subpart C of
part 52 have been or will be met, or a
notice of proposed action with respect
to an application for:
*
*
*
*
*
(4) An amendment to an operating
license, combined license, or
manufacturing license for a facility
licensed under §§ 50.21(b) or 50.22 of
this chapter, or for a testing facility, as
follows:
*
*
*
*
*
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(12) An amendment to an early site
permit issued under subpart A of part
52 of this chapter, as follows:
(i) If the early site permit does not
provide authority to conduct the
activities allowed under § 50.10(e)(1) of
this chapter, the amendment will
involve no significant hazards
consideration, and though the NRC will
provide notice of opportunity for a
hearing under this section, it may make
the amendment immediately effective
and grant a hearing thereafter; and
(ii) If the early site permit provides
authority to conduct the activities
allowed under § 50.10(e)(1) and the
Commission determines under §§ 50.58
and 50.91 of this chapter that an
emergency situation exists or that
exigent circumstances exist and that the
amendment involves no significant
hazards consideration, it will provide
notice of opportunity for a hearing
under § 2.106 of this chapter (if a
hearing is requested, which will be held
after issuance of the amendment).
(13) A manufacturing license under
subpart F of part 52 of this chapter.
(b) * * *
(3) For a notice of intended operation
under § 52.103(a) of this chapter, the
following information:
(i) The identification of the NRC
action as making the finding required
under § 52.103(g) of this chapter;
(ii) The manner in which the licensee
notifications under 10 CFR 52.99(c)
which are required to be made available
by 10 CFR 52.99(e)(2) may be obtained
and examined;
(iii) The manner in which copies of
the safety analysis may be obtained and
examined; and
(iv) Any conditions, limitations, or
restrictions to be placed on the license
in connection with the finding under
§ 52.103(g) of this chapter, and the
expiration date or circumstances (if any)
under which the conditions, limitations
or restrictions will no longer apply.
*
*
*
*
*
I 12. In § 2.106, paragraphs (a) and (b)
are revised to read as follows:
§ 2.106
Notice of issuance.
(a) The Director of New Reactors,
Director of Nuclear Reactor Regulation,
or Director of Nuclear Material Safety
and Safeguards, as appropriate, will
inform the State and local officials
specified in § 2.104(e) and publish a
document in the Federal Register
announcing the issuance of:
(1) A license or an amendment of a
license for which a notice of proposed
action has been previously published;
(2) An amendment of a license for a
facility of the type described in
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§ 50.21(b) or § 50.22 of this chapter, or
a testing facility, whether or not a notice
of proposed action has been previously
published; and
(3) The finding under § 52.103(g) of
this chapter.
(b) The notice of issuance will set
forth:
(1) In the case of a license or
amendment:
(i) The nature of the license or
amendment;
(ii) The manner in which copies of the
safety analysis, if any, may be obtained
and examined; and
(iii) A finding that the application for
the license or amendment complies
with the requirements of the Act and
this chapter.
(2) In the case of a finding under
§ 52.103(g) of this chapter:
(i) The manner in which copies of the
safety analysis, if any, may be obtained
and examined; and
(ii) A finding that the prescribed
inspections, tests, and analyses have
been performed, the prescribed
acceptance criteria have been met, and
that the license complies with the
requirements of the Act and this
chapter.
*
*
*
*
*
I 13. Section 2.109 is revised to read as
follows:
§ 2.109 Effect of timely renewal
application.
(a) Except for the renewal of an
operating license for a nuclear power
plant under 10 CFR 50.21(b) or 50.22, an
early site permit under subpart A of part
52 of this chapter, a manufacturing
license under subpart F of part 52 of this
chapter, or a combined license under
subpart C of part 52 of this chapter, if
at least 30 days before the expiration of
an existing license authorizing any
activity of a continuing nature, the
licensee files an application for a
renewal or for a new license for the
activity so authorized, the existing
license will not be deemed to have
expired until the application has been
finally determined.
(b) If the licensee of a nuclear power
plant licensed under 10 CFR 50.21(b) or
50.22 files a sufficient application for
renewal of either an operating license or
a combined license at least 5 years
before the expiration of the existing
license, the existing license will not be
deemed to have expired until the
application has been finally determined.
(c) If the holder of an early site permit
licensed under subpart A of part 52 of
this chapter files a sufficient application
for renewal under § 52.29 of this chapter
at least 12 months before the expiration
of the existing early site permit, the
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existing permit will not be deemed to
have expired until the application has
been finally determined.
(d) If the licensee of a manufacturing
license under subpart F of part 52 of this
chapter files a sufficient application for
renewal under § 52.177 of this chapter
at least 12 months before the expiration
of the existing license, the existing
license will not be deemed to have
expired until the application has been
finally determined.
I 14. Section 2.110 is revised to read as
follows:
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§ 2.110 Filing and administrative action on
submittals for standard design approval or
early review of site suitability issues.
(a)(1) A submittal for a standard
design approval under subpart E of part
52 of this chapter shall be subject to
§§ 2.101(a) and 2.390 to the same extent
as if it were an application for a permit
or license.
(2) Except as specifically provided
otherwise by the provisions of appendix
Q to parts 50 of this chapter, a submittal
for early review of site suitability issues
under appendix Q to parts 50 of this
chapter shall be subject to §§ 2.101(a)(2)
through (4) to the same extent as if it
were an application for a permit or
license.
(b) Upon initiation of review by the
NRC staff of a submittal for an early
review of site suitability issues under
appendix Q of parts 50 of this chapter,
or for a standard design approval under
subpart E of part 52 of this chapter, the
Director of New Reactors or the Director
of Nuclear Reactor Regulation shall
publish in the Federal Register a notice
of receipt of the submittal, inviting
comments from interested persons
within 60 days of publication or other
time as may be specified, for
consideration by the NRC staff and
ACRS in their review.
(c)(1) Upon completion of review by
the NRC staff and the ACRS of a
submittal for a standard design
approval, the Director of New Reactors
or the Director of the Office of Nuclear
Reactor Regulation shall publish in the
Federal Register a determination as to
whether or not the design is acceptable,
subject to terms and conditions as may
be appropriate, and shall make available
at the NRC Web site, https://
www.nrc.gov, a report that analyzes the
design.
(2) Upon completion of review by the
NRC staff and, if appropriate by the
ACRS, of a submittal for early review of
site suitability issues, the NRC staff
shall prepare a staff site report which
shall identify the location of the site,
state the site suitability issues reviewed,
explain the nature and scope of the
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review, state the conclusions of the staff
regarding the issues reviewed and state
the reasons for those conclusions. Upon
issuance of an NRC staff site report, the
NRC staff shall publish a notice of the
availability of the report in the Federal
Register and shall make the report
available at the NRC Web site, https://
www.nrc.gov. The NRC staff shall also
send a copy of the report to the
Governor or other appropriate official of
the State in which the site is located,
and to the chief executive of the
municipality in which the site is located
or, if the site is not located in a
municipality, to the chief executive of
the county.
I 15. Section 2.111 is revised to read as
follows:
requirements of § 52.145 of this chapter
must be followed unless the applicant
or licensee has consented to follow the
action required.
(6) If the order involves a
modification of a manufacturing license
under subpart F of part 52, the
requirements of § 52.171 of this chapter
must be followed, unless the applicant
or licensee has consented to the action
required.
I 17. In § 2.309, paragraphs (a), (f)(1)(i),
(f)(1)(v), and (f)(1)(vi) are revised, a new
paragraph (f)(1)(vii) is added, and
paragraphs (g), (h)(2), and (i) are revised
to read as follows:
§ 2.111
(a) General requirements. Any person
whose interest may be affected by a
proceeding and who desires to
participate as a party must file a written
request for hearing and a specification
of the contentions which the person
seeks to have litigated in the hearing. In
a proceeding under 10 CFR 52.103, the
Commission, acting as the presiding
officer, will grant the request if it
determines that the requestor has
standing under the provisions of
paragraph (d) of this section and has
proposed at least one admissible
contention that meets the requirements
of paragraph (f) of this section. For all
other proceedings, except as provided in
paragraph (e) of this section, the
Commission, presiding officer, or the
Atomic Safety and Licensing Board
designated to rule on the request for
hearing and/or petition for leave to
intervene, will grant the request/petition
if it determines that the requestor/
petitioner has standing under the
provisions of paragraph (d) of this
section and has proposed at least one
admissible contention that meets the
requirements of paragraph (f) of this
section. In ruling on the request for
hearing/petition to intervene submitted
by petitioners seeking to intervene in
the proceeding on the HLW repository,
the Commission, the presiding officer,
or the Atomic Safety and Licensing
Board shall also consider any failure of
the petitioner to participate as a
potential party in the pre-license
application phase under subpart J of this
part in addition to the factors in
paragraph (d) of this section. If a request
for hearing or petition to intervene is
filed in response to any notice of
hearing or opportunity for hearing, the
applicant/licensee shall be deemed to be
a party.
*
*
*
*
*
(f) * * *
(1) * * *
Prohibition of sex discrimination.
No person shall on the grounds of sex
be excluded from participation in, be
denied a license, standard design
approval, or petition for rulemaking
(including a design certification), be
denied the benefits of, or be subjected
to discrimination under any program or
activity carried on or receiving Federal
assistance under the Act or the Energy
Reorganization Act of 1974.
I 16. In § 2.202, paragraph (e) is revised
to read as follows:
§ 2.202
Orders.
*
*
*
*
*
(e)(1) If the order involves the
modification of a part 50 license and is
a backfit, the requirements of § 50.109 of
this chapter shall be followed, unless
the licensee has consented to the action
required.
(2) If the order involves the
modification of combined license under
subpart C of part 52 of this chapter, the
requirements of § 52.98 of this chapter
shall be followed unless the licensee has
consented to the action required.
(3) If the order involves a change to
an early site permit under subpart A of
part 52 of this chapter, the requirements
of § 52.39 of this chapter must be
followed, unless the applicant or
licensee has consented to the action
required.
(4) If the order involves a change to
a standard design certification rule
referenced by that plant’s application,
the requirements, if any, in the
referenced design certification rule with
respect to changes must be followed, or,
in the absence of these requirements,
the requirements of § 52.63 of this
chapter must be followed, unless the
applicant or licensee has consented to
follow the action required.
(5) If the order involves a change to
a standard design approval referenced
by that plant’s application, the
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§ 2.309 Hearing requests, petitions to
intervene, requirements for standing, and
contentions.
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(i) Provide a specific statement of the
issue of law or fact to be raised or
controverted, provided further, that the
issue of law or fact to be raised in a
request for hearing under 10 CFR
52.103(b) must be directed at
demonstrating that one or more of the
acceptance criteria in the combined
license have not been, or will not be
met, and that the specific operational
consequences of nonconformance
would be contrary to providing
reasonable assurance of adequate
protection of the public health and
safety;
*
*
*
*
*
(v) Provide a concise statement of the
alleged facts or expert opinions which
support the requestor’s/petitioner’s
position on the issue and on which the
petitioner intends to rely at hearing,
together with references to the specific
sources and documents on which the
requestor/petitioner intends to rely to
support its position on the issue;
(vi) In a proceeding other than one
under 10 CFR 52.103, provide sufficient
information to show that a genuine
dispute exists with the applicant/
licensee on a material issue of law or
fact. This information must include
references to specific portions of the
application (including the applicant’s
environmental report and safety report)
that the petitioner disputes and the
supporting reasons for each dispute, or,
if the petitioner believes that the
application fails to contain information
on a relevant matter as required by law,
the identification of each failure and the
supporting reasons for the petitioner’s
belief; and
(vii) In a proceeding under 10 CFR
52.103(b), the information must be
sufficient, and include supporting
information showing, prima facie, that
one or more of the acceptance criteria in
the combined license have not been, or
will not be met, and that the specific
operational consequences of
nonconformance would be contrary to
providing reasonable assurance of
adequate protection of the public health
and safety. This information must
include the specific portion of the report
required by 10 CFR 52.99(c) which the
requestor believes is inaccurate,
incorrect, and/or incomplete (i.e., fails
to contain the necessary information
required by § 52.99(c)). If the requestor
identifies a specific portion of the
§ 52.99(c) report as incomplete and the
requestor contends that the incomplete
portion prevents the requestor from
making the necessary prima facie
showing, then the requestor must
explain why this deficiency prevents
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the requestor from making the prima
facie showing.
*
*
*
*
*
(g) Selection of hearing procedures. A
request for hearing and/or petition for
leave to intervene may, except in a
proceeding under 10 CFR 52.103, also
address the selection of hearing
procedures, taking into account the
provisions of § 2.310. If a request/
petition relies upon § 2.310(d), the
request/petition must demonstrate, by
reference to the contention and the
bases provided and the specific
procedures in subpart G of this part, that
resolution of the contention necessitates
resolution of material issues of fact
which may be best determined through
the use of the identified procedures.
(h) * * *
(2) Except in a proceeding under 10
CFR 52.103, the requestor/petitioner
may file a reply to any answer. The
reply must be filed within 7 days after
service of that answer.
*
*
*
*
*
(i) Decision on request/petition. In all
proceedings other than a proceeding
under 10 CFR 52.103, the presiding
officer shall, within 45 days after the
filing of answers and replies under
paragraph (h) of this section, issue a
decision on each request for hearing/
petition to intervene, absent an
extension from the Commission. The
Commission, acting as the presiding
officer, shall expeditiously grant or deny
the request for hearing in a proceeding
under 10 CFR 52.103. The
Commission’s decision may not be the
subject of any appeal under 10 CFR
2.311.
I 18. In § 2.310, paragraph (j) is
redesignated as paragraph (k), and a
new paragraph (j) is added to read as
follows:
§ 2.310
Selection of hearing procedures.
*
*
*
*
*
(j) Proceedings on a Commission
finding under 10 CFR 52.103(c) and (g)
shall be conducted in accordance with
the procedures designated by the
Commission in each proceeding.
*
*
*
*
*
I 19. In § 2.339, paragraph (d) is revised
to read as follows:
§ 2.339 Expedited decisionmaking
procedure.
*
*
*
*
*
(d) The provisions of this section do
not apply to an initial decision directing
the issuance of a limited work
authorization under 10 CFR 50.10, an
early site permit under subpart A of part
52 of this chapter, a construction permit
or construction authorization, a
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49475
combined license under subpart C of
part 52 of this chapter, or a
manufacturing license under subpart F
of part 52.
I 20. Section 2.340 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.
(a) Initial decision—production or
utilization facility operating license. In
any initial decision in a contested
proceeding on an application for an
operating license (including an
amendment to or renewal of an
operating license) for a production or
utilization facility, the presiding officer
shall make findings of fact and
conclusions of law on the matters put
into controversy by the parties to the
proceeding, any matter designated by
the Commission to be decided by the
presiding officer, and any matter not put
into controversy by the parties, but only
to the extent that the presiding officer
determines that a serious safety,
environmental, or common defense and
security matter exists, and the
Commission approves of an
examination of and decision on the
matter upon its referral by the presiding
officer. Depending on the resolution of
those matters, the Commission, the
Director of Nuclear Reactor Regulation,
or the Director of New Reactors, as
appropriate, after making the requisite
findings, will issue, deny or
appropriately condition the license.
(b) Initial decision—combined license
under 10 CFR part 52. In any initial
decision in a contested proceeding on
an application for a combined license
(including an amendment to or renewal
of a combined license) under subpart C
of part 52 of this chapter, the presiding
officer shall make findings of fact and
conclusions of law on the matters put
into controversy by the parties to the
proceeding, and any matter designated
by the Commission to be decided by the
presiding officer. Depending on the
resolution of those matters, the
Commission, the Director of New
Reactors, or the Director of Nuclear
Reactor Regulation, as appropriate, after
making the requisite findings, will
issue, deny or appropriately condition
the license.
(c) Initial decision on finding under
10 CFR 52.103 with respect to
acceptance criteria in nuclear power
reactor combined licenses. In any initial
decision under § 52.103(g) of this
chapter with respect to whether
acceptance criteria have been or will be
met, the presiding officer shall make
findings of fact and conclusions of law
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on the matters put into controversy by
the parties to the proceeding, and on
any matters designated by the
Commission to be decided by the
presiding officer. Matters not put into
controversy by the parties shall be
referred to the Commission for its
determination. The Commission may, in
its discretion, treat the matter as a
request for action under 10 CFR 2.206
and process the matter in accordance
with § 52.103(f). Depending on the
resolution of those matters, the
Commission, the Director of New
Reactors, or the Director of Nuclear
Reactor Regulation, as appropriate, will
make the finding under 10 CFR 52.103,
or appropriately condition that finding.
(d) Initial decision—manufacturing
license under 10 CFR part 52. In any
initial decision in a contested
proceeding on an application for a
manufactured license (including an
amendment to or renewal of a combined
license) under subpart C of part 52 of
this chapter, the presiding officer shall
make findings of fact and conclusions of
law on the matters put into controversy
by the parties to the proceeding, and
any matter designated by the
Commission to be decided by the
presiding officer. Depending on the
resolution of those matters, the
Commission, the Director of New
Reactors, or the Director of Nuclear
Reactor Regulation, as appropriate, after
making the requisite findings, will
issue, deny, or appropriately condition
the manufacturing license.
(e) Initial decision—other proceedings
not involving production or utilization
facilities. In proceedings not involving
production or utilization facilities, the
presiding officer shall make findings of
fact and conclusions of law on the
matters put into controversy by the
parties to the proceeding, and on any
matters designated by the Commission
to be decided by the presiding officer.
Matters not put into controversy by the
parties must be referred to the Director
of Nuclear Material Safety and
Safeguards, or the Director of the Office
of Federal and State Materials and
Environmental Management Programs,
as appropriate. Depending on the
resolution of those matters, the Director
of Nuclear Material Safety and
Safeguards or the Director of the Office
of Federal and State Materials and
Environmental Management Programs,
as appropriate, after making the
requisite findings, will issue, deny,
revoke or appropriately condition the
license, or take other action as necessary
or appropriate.
(f) Immediate effectiveness of certain
decisions. An initial decision directing
the issuance or amendment of a limited
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work authorization under 10 CFR 50.10,
an early site permit under subpart A of
part 52 of this chapter, a construction
permit or construction authorization
under part 50 of this chapter, an
operating license under part 50 of this
chapter, a combined license under
subpart C of part 52 of this chapter, a
manufacturing license under subpart F
of part 52 of this chapter, or a license
under 10 CFR part 72 to store spent fuel
in an independent spent fuel storage
facility (ISFSI) or a monitored
retrievable storage installation (MRS),
an initial decision directing issuance of
a license under part 61 of this chapter,
or an initial decision under 10 CFR
52.103(g) that acceptance criteria in a
combined license have been met, is
immediately effective upon issuance
unless the presiding officer finds that
good cause has been shown by a party
why the initial decision should not
become immediately effective.
(g)–(h) [Reserved]
(i) Issuance of authorizations,
permits, and licenses—production and
utilization facilities. The Commission,
the Director of New Reactors, or the
Director of Nuclear Reactor Regulation,
as appropriate, shall issue a limited
work authorization under 10 CFR 50.10,
an early site permit under subpart A of
part 52 of this chapter, a construction
permit or construction authorization
under part 50 of this chapter, an
operating license under part 50 of this
chapter, a combined license under
subpart C of part 52 of this chapter, or
a manufacturing license under subpart F
of part 52 of this chapter within 10 days
from the date of issuance of the initial
decision:
(1) If the Commission or the
appropriate Director has made all
findings necessary for issuance of the
authorization, permit or license, not
within the scope of the initial decision
of the presiding officer; and
(2) Notwithstanding the pendency of
a petition for reconsideration under
§ 2.345, a petition for review under
§ 2.341, or a motion for stay under
§ 2.342, or the filing of a petition under
§ 2.206.
(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 have been, or will be
met, within 10 days from the date of
issuance of the initial decision:
(1) If the Commission or the
appropriate Director has made the
finding under § 52.103(g) that
acceptance criteria have been, or will be
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met, for those acceptance criteria which
are not within the scope of the initial
decision of the presiding officer; and
(2) Notwithstanding the pendency of
a petition for reconsideration under
§ 2.345, a petition for review under
§ 2.341, or a motion for stay under
§ 2.342, or the filing of a petition under
§ 2.206.
(k) Issuance of other licenses. The
Commission or the Director of Nuclear
Material Safety and Safeguards, or the
Director of the Office of Federal and
State Materials and Environmental
Management Programs, as appropriate,
shall issue a license, including a license
under 10 CFR part 72 to store spent fuel
in either an independent spent fuel
storage facility (ISFSI) located away
from a reactor site or at a monitored
retrievable storage installation (MRS),
within 10 days from the date of issuance
of the initial decision:
(1) If the Commission or the
appropriate Director has made all
findings necessary for issuance of the
license, not within the scope of the
initial decision of the presiding officer;
and
(2) Notwithstanding the pendency of
a petition for reconsideration under
§ 2.345, a petition for review under
§ 2.341, or a motion for stay under
§ 2.342, or the filing of a petition under
§ 2.206.
I 21. In § 2.341, paragraph (a)(1) is
revised to read as follows:
§ 2.341 Review of decisions and actions of
a presiding officer.
(a)(1) Except for requests for review or
appeals under § 2.311 or in a proceeding
on the high-level radioactive waste
repository (which are governed by
§ 2.1015), review of decisions and
actions of a presiding officer are treated
under this section, provided, however,
that no party may request a further
Commission review of a Commission
determination to allow a period of
interim operation under 10 CFR
52.103(c).
*
*
*
*
*
I 22. In § 2.347, paragraph (a) is revised,
and new paragraph (f)(5) is added to
read as follows:
§ 2.347
Ex parte communications.
*
*
*
*
*
(a)(1) Interested persons outside the
agency may not make or knowingly
cause to be made to any Commission
adjudicatory employee, any ex parte
communication relevant to the merits of
the proceeding.
(2) For purposes of this section, merits
of the proceeding includes:
(i) A disputed issue;
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(ii) A matter which a presiding officer
seeks to be referred to the Commission
under 10 CFR 2.340(a); and
(iii) A matter for which the
Commission has approved examination
by the presiding officer under § 2.340(a).
*
*
*
*
*
(f) * * *
(5) Communications, in contested
proceedings and uncontested mandatory
proceeding, regarding an undisputed
issue.
I 23. In § 2.348, the introductory text of
paragraph (a) is revised, and new
paragraphs (d)(1)(iii), (d)(1)(iv), and
(d)(3) are added to read as follows:
§ 2.348
Separation of functions.
(a) In any proceeding under this part,
any NRC officer or employee engaged in
the performance of any investigative or
litigating function in the proceeding or
in a factually related proceeding with
respect to a disputed issue in that
proceeding, may not participate in or
advise a Commission adjudicatory
employee about the initial or final
decision with respect to that disputed
issue, except—
*
*
*
*
*
(d) * * *
(1) * * *
(iii) A matter which a presiding
officer seeks to be referred to the
Commission under 10 CFR 2.340(a); and
(iv) A matter for which the
Commission has approved examination
by the presiding officer under § 2.340(a).
*
*
*
*
*
(3) Separation of functions does not
apply to uncontested proceedings, or to
an undisputed issue in contested initial
licensing proceedings.
*
*
*
*
*
I 24. In § 2.390, the introductory text of
paragraph (a) is revised to read as
follows:
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§ 2.390 Public inspections, exemptions,
requests for withholding.
(a) Subject to the provisions of
paragraphs (b), (d), (e), and (f) of this
section, final NRC records and
documents, including but not limited to
correspondence to and from the NRC
regarding the issuance, denial,
amendment, transfer, renewal,
modification, suspension, revocation, or
violation of a license, permit, order, or
standard design approval, or regarding a
rulemaking proceeding subject to this
part shall not, in the absence of an NRC
determination of a compelling reason
for nondisclosure after a balancing of
the interests of the person or agency
urging nondisclosure and the public
interest in disclosure, be exempt from
disclosure and will be made available
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for inspection and copying at the NRC
Web site, https://www.nrc.gov, and/or at
the NRC Public Document Room, except
for matters that are:
*
*
*
*
*
I 25. Subpart D is revised to read as
follows:
Subpart D—Additional Procedures
Applicable to Proceedings for the
Issuance of Licenses To Construct
and/or Operate Nuclear Power Plants
of Identical Design at Multiple Sites
Sec.
2.400 Scope of subpart.
2.401 Notice of hearing on construction
permit or combined license applications
pursuant to appendix N of 10 CFR parts
50 or 52.
2.402 Separate hearings on separate issues;
consolidation of proceedings.
2.403 Notice of proposed action on
applications for operating licenses
pursuant to appendix N of 10 CFR part
50.
2.404 Hearings on applications for
operating licenses pursuant to appendix
N of 10 CFR part 50.
2.405 Initial decisions in consolidated
hearings.
2.406 Finality of decisions on separate
issues.
2.407 Applicability of other sections.
§ 2.400
Scope of subpart.
This subpart describes procedures
applicable to licensing proceedings
which involve the consideration in
hearings of a number of applications,
filed by one or more applicants
pursuant to appendix N of parts 50 or
52 of this chapter, for licenses to
construct and/or operate nuclear power
reactors of identical design to be located
at multiple sites.
§ 2.401 Notice of hearing on construction
permit or combined license applications
pursuant to appendix N of 10 CFR parts 50
or 52.
(a) In the case of applications
pursuant to appendix N of part 50 of
this chapter for construction permits for
nuclear power reactors of the type
described in § 50.22 of this chapter, or
applications pursuant to appendix N of
part 52 of this chapter for combined
licenses, the Secretary will issue notices
of hearing pursuant to § 2.104.
(b) The notice of hearing will also
state the time and place of the hearings
on any separate phase of the proceeding.
§ 2.402 Separate hearings on separate
issues; consolidation of proceedings.
(a) In the case of applications under
appendix N of part 50 of this chapter for
construction permits for nuclear power
reactors of a type described in 10 CFR
50.22, or applications pursuant to
appendix N of part 52 of this chapter for
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49477
combined licenses, the Commission or
the presiding officer may order separate
hearings on particular phases of the
proceeding, such as matters related to
the acceptability of the design of the
reactor, in the context of the site
parameters postulated for the design or
environmental matters.
(b) If a separate hearing is held on a
particular phase of the proceeding, the
Commission or presiding officers of
each affected proceeding may, under 10
CFR 2.317, consolidate for hearing on
that phase two or more proceedings to
consider common issues relating to the
applications involved in the
proceedings, if it finds that this action
will be conducive to the proper dispatch
of its business and to the ends of justice.
In specifying the place of this
consolidated hearing, due regard will be
given to the convenience and necessity
of the parties, petitioners for leave to
intervene, or the attorneys or
representatives of such persons, and the
public interest.
§ 2.403 Notice of proposed action on
applications for operating licenses
pursuant to appendix N of 10 CFR part 50.
In the case of applications pursuant to
appendix N of part 50 of this chapter for
operating licenses for nuclear power
reactors, if the Commission has not
found that a hearing is in the public
interest, the Commission, the Director of
New Reactors, or the Director of Nuclear
Reactor Regulation will, prior to acting
thereon, cause to be published in the
Federal Register, pursuant to § 2.105, a
notice of proposed action with respect
to each application as soon as
practicable after the applications have
been docketed.
§ 2.404 Hearings on applications for
operating licenses pursuant to appendix N
of 10 CFR part 50.
If a request for a hearing and/or
petition for leave to intervene is filed
within the time prescribed in the notice
of proposed action on an application for
an operating license pursuant to
appendix N of part 50 of this chapter
with respect to a specific reactor(s) at a
specific site, and the Commission, the
Chief Administrative Judge, or a
presiding officer has issued a notice of
hearing or other appropriate order, then
the Commission, the Chief
Administrative Judge, or the presiding
officer may order separate hearings on
particular phases of the proceeding and/
or consolidate for hearing two or more
proceedings in the manner described in
§ 2.402.
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§ 2.405 Initial decisions in consolidated
hearings.
At the conclusion of a hearing held
under this subpart, the presiding officer
will render a partial initial decision on
the common design. The partial initial
decision on the common design may be
appealed under § 2.341. If the
proceedings have also been
consolidated with respect to matters
other than the common design under
§ 2.317(b), the presiding officer may
issue a consolidated partial initial
decision for those proceedings. No
construction permit, full-power
operating license, or combined license
under part 52 of this chapter will be
issued until an initial decision has been
issued on all phases of the hearing and
all issues under the Act and the
National Environmental Policy Act of
1969 appropriate to the proceeding have
been resolved.
§ 2.501 Notice of hearing on application
under subpart F of 10 CFR part 52 for a
license to manufacture nuclear power
reactors.
(a) In the case of an application under
subpart F of part 52 of this chapter for
a license to manufacture nuclear power
reactors of the type described in § 50.22
of this chapter to be operated at sites not
identified in the license application, the
Secretary will issue a notice of hearing
to be published in the Federal Register
at least 30 days before the date set for
hearing in the notice.1 The notice shall
be issued as soon as practicable after the
application has been docketed. The
notice will state:
*
*
*
*
*
(b) The notice of hearing shall comply
with the requirements of § 2.104(f) of
this chapter.
*
*
*
*
*
§ 2.502
I
§ 2.406 Finality of decisions on separate
issues.
28. Remove and reserve § 2.502.
§ 2.503
I
§ 2.407
Sec.
2.600
2.601
The provisions of subparts A, C, G, L,
and N of this part relating to
construction permits, operating licenses,
and combined licenses apply,
respectively, to construction permits,
operating licenses, and combined
licenses subject to this subpart, except
as may be qualified by the provisions of
this subpart.
26. Section 2.500 is revised to read as
follows:
I
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§ 2.500
Scope of subpart.
This subpart prescribes procedures
applicable to licensing proceedings
which involve the consideration in
separate hearings of an application for a
license to manufacture nuclear power
reactors under subpart F of part 52 of
this chapter.
27. In § 2.501, the section heading, the
introductory text of paragraph (a) and
paragraph (b) are revised to read as
follows:
I
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[Removed]
29. Remove and reserve § 2.503.
Notwithstanding any other provision
of this chapter, in a proceeding
conducted pursuant to this subpart and
appendices N of parts 50 or 52 of this
chapter, no matter which has been
reserved for consideration in one phase
of the hearing shall be considered at
another phase of the hearing except on
the basis of significant new information
that substantially affects the
conclusion(s) reached at the other phase
or other good cause.
Applicability of other sections.
[Removed]
§ 2.504
[Removed]
30. Remove and reserve § 2.504.
I 31. Subpart F is revised to read as
follows:
I
Subpart F—Additional Procedures
Applicable to Early Partial Decisions
on Site Suitability Issues in
Connection With an Application for a
Construction Permit or Combined
License for Certain Utilization Facilities
Scope of subpart.
Applicability of other sections.
Early Partial Decisions on Site Suitability—
Construction Permit
2.602 Filing Fees.
2.603 Acceptance and docketing of
application for early review of site
suitability issues in a construction
permit proceeding.
2.604 Notice of hearing on application for
early review of site suitability issues in
construction permit proceeding.
2.605 Additional considerations.
2.606 Partial decision on site suitability
issues in construction permit
proceeding.
Early Partial Decisions on Site Suitability—
Combined License Under 10 CFR Part 52
2.621 Acceptance and docketing of
application for early review of site
suitability issues in a combined license
proceeding.
1 The thirty-day (30) requirement of this
paragraph is not applicable to a notice of the time
and place of hearing published by the presiding
officer after the notice of hearing described in this
section has been published.
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2.623 Notice of hearing on application for
early review of site suitability issues in
combined license proceeding.
2.625 Additional considerations.
2.627 Partial decision on site suitability
issues in combined license proceeding.
2.629 Finality of partial decision on site
suitability issues in combined license
proceeding.
§ 2.600
Scope of subpart.
This subpart prescribes procedures
applicable to licensing proceedings
which involve an early submittal of site
suitability information in accordance
with § 2.101(a–1) and (a–2), and a
hearing and early partial decision on
issues of site suitability, in connection
with an application for a permit to
construct a utilization facility which is
subject to § 51.20(b) of this chapter and
is of the type specified in § 50.21(b)(2)
or (3) or § 50.22 of this chapter or is a
testing facility; or an application for a
combined license under part 52 of this
chapter for a nuclear power facility.
(a) The procedures in §§ 2.601
through 2.609 apply to all applications
under this subpart.
(b) The procedures in §§ 2.611
through 2.619 apply to applications for
a permit to construct a utilization
facility which is subject to § 51.20(b) of
this chapter and is of the type specified
in § 50.21(b)(2) or (3) or § 50.22 of this
chapter or is a testing facility.
(c) The procedures in §§ 2.621
through 2.629 apply to applications for
combined license under part 52 of this
chapter for a nuclear power facility.
§ 2.601
Applicability of other sections.
The provisions of subparts A, C, G, L,
and N relating to applications for
construction permits and combined
licenses, and proceedings thereon
apply, respectively, to such applications
and proceedings in accordance with this
subpart, except as specifically provided
otherwise by the provisions of this
subpart.
Early Partial Decisions on Site
Suitability—Construction Permit
§ 2.602
Filing fees.
Each application which contains a
request for early review of site
suitability issues under the procedures
of this subpart shall be accompanied by
any fee required by § 50.30(e) and part
170 of this chapter.
§ 2.603 Acceptance and docketing of
application for early review of site
suitability issues in a construction permit
proceeding.
(a) Each part of an application for a
construction permit submitted in
accordance with § 2.101(a–1) of this part
will be initially treated as a tendered
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application. If it is determined that any
one of the parts as described in
§ 2.101(a–1) is incomplete and not
acceptable for processing, the Director
of the Office of New Reactors or the
Director of the Office of Nuclear Reactor
Regulation, as appropriate, will inform
the applicant of this determination and
the respects in which the document is
deficient. Such a determination of
completeness will generally be made
within a period of 30 days.
(b)(1) The Director of the Office of
New Reactors or the Director of the
Office of Nuclear Reactor Regulation, as
appropriate, will accept for docketing
part one of an application for a
construction permit for a utilization
facility which is subject to § 51.20(b) of
this chapter and is of the type specified
in § 50.21(b)(2) or (3) or § 50.22 of this
chapter, or is a testing facility where
part one of the application as described
in § 2.101(a–1) is complete. Part one of
any application will not be considered
complete unless it contains proposed
findings as required by § 2.101(a–1)(1)(i)
and unless it describes the applicant’s
site selection process, specifies the
extent to which that process involves
the consideration of alternative sites,
explains the relationship between that
process and the application for early
review of site suitability issues, and
briefly describes the applicant’s longrange plans for ultimate development of
the site. Upon assignment of a docket
number, the procedures in § 2.101(a)(3)
and (4) relating to formal docketing and
the submission and distribution of
additional copies of the application
shall be followed.
(2) Additional parts of the application
will be docketed upon a determination
by the Director of the Office of New
Reactors or the Director of the Office of
Nuclear Reactor Regulation, as
appropriate, that they are complete.
(c) If part one of the application is
docketed, the Director of the Office of
New Reactors or the Director of the
Office of Nuclear Reactor Regulation, as
appropriate, will cause to be published
in the Federal Register and send to the
Governor or other appropriate official of
the State in which the site is located, a
notice of docketing of the application
which states the purpose of the
application, states the location of the
proposed site, states that a notice of
hearing will be published, requests
comments within 120 days or such
other time as may be specified on the
initiation or outcome of an early site
review from Federal, State, and local
agencies and interested persons.
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§ 2.604 Notice of hearing on application
for early review of site suitability issues in
construction permit proceeding.
(a) Where an applicant for a
construction permit requests an early
review and hearing and an early partial
decision on issues of site suitability
pursuant to § 2.101(a–1), the provisions
in the notice of hearing setting forth the
matters of fact and law to be considered,
as required by § 2.104, shall be modified
so as to relate only to the site suitability
issue or issues under review.
(b) After docketing of part two of the
application, as provided in §§ 2.101(a–
1) and 2.603, a supplementary notice of
hearing will be published under § 2.104
with respect to the remaining
unresolved issues in the proceeding
within the scope of § 2.104. This
supplementary notice of hearing will
provide that any person whose interest
may be affected by the proceeding and
who desires to participate as a party in
the resolution of the remaining issues
shall file a petition for leave to intervene
pursuant to § 2.309 within the time
prescribed in the notice. This
supplementary notice will also provide
appropriate opportunities for
participation by a representative of an
interested State under § 2.315(c) and for
limited appearances under § 2.315(a).
(c) Any person who was permitted to
intervene as a party under the initial
notice of hearing on site suitability
issues and who was not dismissed or
did not withdraw as a party may
continue to participate as a party to the
proceeding with respect to the
remaining unresolved issues, provided
that within the time prescribed for filing
of petitions for leave to intervene in the
supplementary notice of hearing, he or
she files a notice of his intent to
continue as a party, along with a
supporting affidavit identifying the
specific aspect or aspects of the subject
matter of the proceeding as to which he
or she wishes to continue to participate
as a party and setting forth with
particularity the basis for his
contentions with regard to each aspect
or aspects. A party who files a nontimely notice of intent to continue as a
party may be dismissed from the
proceeding, absent a determination that
the party has made a substantial
showing of good cause for failure to file
on time, and with particular reference to
the factors specified in §§ 2.309(c)(1)(i)
through (iv) and 2.309(d). The notice
will be ruled upon by the Commission
or presiding officer designated to rule
on petitions for leave to intervene.
(d) To the maximum extent
practicable, the membership of any
atomic safety and licensing board
designated to preside in the proceeding
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49479
on the remaining unresolved issues
pursuant to the supplemental notice of
hearing will be the same as the
membership designated to preside in
the initial notice of hearing on site
suitability issues.
§ 2.605
Additional considerations.
(a) The Commission will not conduct
more than one review of site suitability
issues with regard to a particular site
prior to filing and review of part two of
the application described in § 2.101(a–1)
of this part.
(b) The Commission, upon its own
initiative, or upon the motion of any
party to the proceeding filed at least 60
days prior to the date of the
commencement of the evidentiary
hearing on site suitability issues, may
decline to initiate an early hearing or
render an early partial decision on any
issue or issues of site suitability:
(1) In cases where no partial decision
on the relative merits of the proposed
site and alternative sites under subpart
A of part 51 of this chapter is requested,
upon determination that there is a
reasonable likelihood that further
review would identify one or more
preferable alternative sites and the
partial decision on one or more site
suitability issues would lead to an
irreversible and irretrievable
commitment of resources prior to the
submittal of the remainder of the
information required by § 50.30(f) of this
chapter that would prejudice the later
review and decision on such alternative
sites; or
(2) In cases where it appears that an
early partial decision on any issue or
issues of site suitability would not be in
the public interest considering:
(i) The degree of likelihood that any
early findings on those issues would
retain their validity in later reviews;
(ii) The objections, if any, of cognizant
State or local government agencies to
the conduct of an early review on those
issues; and
(iii) The possible effect on the public
interest and the parties of having an
early, if not necessarily conclusive,
resolution of those issues.
§ 2.606 Partial decision on site suitability
issues in construction permit proceeding.
(a) The provisions of §§ 2.331, 2.339,
2.340, 2.343, 2.712, and 2.713 shall
apply to any partial initial decision
rendered in accordance with this
subpart. A limited work authorization
may not be issued under 10 CFR
50.10(e) and no construction permit
may be issued without completion of
the full review required by Section
102(2) of the National Environmental
Policy Act of 1969, as amended, and
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rwilkins on PROD1PC63 with RULES2
subpart A of part 51 of this chapter. The
authority of the Commission to review
such a partial initial decision sua
sponte, or to raise sua sponte an issue
that has not been raised by the parties,
will be exercised within the same time
period as in the case of a full decision
relating to the issuance of a construction
permit.
(b)(1) A partial decision on one or
more site suitability issues pursuant to
the applicable provisions of part 50,
subpart A of part 51, and part 100 of this
chapter issued in accordance with this
subpart shall:
(i) Clearly identify the site to which
the partial decision applies; and
(ii) Indicate to what extent additional
information may be needed and
additional review may be required to
enable the Commission to determine in
accordance with the provisions of the
Act and the applicable provisions of the
regulations in this chapter whether a
construction permit for a facility to be
located on the site identified in the
partial decision should be issued or
denied.
(2) Following either the Commission
(acting in the function of a presiding
officer) issuance of a partial initial
decision, or completion of Commission
review of the partial initial decision of
the Atomic Safety and Licensing Board,
after hearing, on the site suitability
issues, the partial decision shall remain
in effect either for a period of 5 years or,
where the applicant for the construction
permit has made timely submittal of the
information required to support the
application as provided in § 2.101(a–1),
until the proceeding for a permit to
construct a facility on the site identified
in the partial decision has been
concluded,3 unless the Commission or
Atomic Safety and Licensing Board,
upon its own initiative or upon motion
by a party to the proceeding, finds that
there exists significant new information
that substantially affects the earlier
conclusions and reopens the hearing
record on site suitability issues. Upon
good cause shown, the Commission may
extend the 5-year period during which
a partial decision shall remain in effect
for a reasonable period of time not to
exceed 1 year.
3 The partial decision on site suitability issues
shall be incorporated in the decision regarding
issuance of the combined license to the extent that
it serves as a basis for the decision on a specific site
issue.
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Early Partial Decisions on Site
Suitability—Combined License Under
10 CFR Part 52
§ 2.621 Acceptance and docketing of
application for early review of site
suitability issues in a combined license
proceeding.
(a) Each part of an application
submitted in accordance with § 2.101(a–
1) of this part will be initially treated as
a tendered application. If it is
determined that any one of the parts as
described in § 2.101(a–1) is incomplete
and not acceptable for processing, the
Director of the Office of New Reactors
or the Director of the Office of Nuclear
Reactor Regulation, as appropriate, will
inform the applicant of this
determination and the respects in which
the document is deficient. Such a
determination of completeness will
generally be made within a period of 30
days.
(b)(1) The Director of the Office of
New Reactors or the Director of the
Office of Nuclear Reactor Regulation, as
appropriate, will accept for docketing an
application for a combined license for a
nuclear power facility where part one of
the application as described in
§ 2.101(a–1) is complete. Part one of any
application will not be considered
complete unless it contains proposed
findings as required by § 2.101(a–1)(1)(i)
and unless it describes the applicant’s
site selection process, specifies the
extent to which that process involves
the consideration of alternative sites,
explains the relationship between that
process and the application for early
review of site suitability issues, and
briefly describes the applicant’s longrange plans for ultimate development of
the site. Upon assignment of a docket
number, the procedures in § 2.101(a)(3)
and (4) relating to formal docketing and
the submission and distribution of
additional copies of the application
shall be followed.
(2) Additional parts of the application
will be docketed upon a determination
by the Director of the Office of New
Reactors or the Director of the Office of
Nuclear Reactor Regulation, as
appropriate, that they are complete.
(c) If part one of the application is
docketed, the Director of the Office of
New Reactors or the Director of the
Office of Nuclear Reactor Regulation, as
appropriate, will cause to be published
in the Federal Register and send to the
Governor or other appropriate official of
the State in which the site is located, a
notice of docketing of the application
which states the purpose of the
application, states the location of the
proposed site, states that a notice of
hearing will be published, requests
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comments within 120 days or such
other time as may be specified on the
initiation or outcome of an early site
review from Federal, State, and local
agencies and interested persons.
§ 2.623 Notice of hearing on application
for early review of site suitability issues in
combined license proceeding.
(a) Where an applicant for a combined
license under part 52 of this chapter
requests an early review and hearing
and an early partial decision on issues
of site suitability pursuant to § 2.101(a–
2), the provisions in the notice of
hearing setting forth the matters of fact
and law to be considered, as required by
§ 2.104, shall be modified so as to relate
only to the site suitability issue or issues
under review. The notice will provide
appropriate opportunities for
participation by a representative of an
interested State under § 2.315(c) and for
limited appearances under § 2.315(a),
limited however, to the issues of site
suitability for which early review has
been requested by the applicant.
(b) After docketing of part two of the
application, as provided in §§ 2.101(a–
1) and 2.603, a supplementary notice of
hearing will be published under § 2.104
with respect to the remaining
unresolved issues in the proceeding
within the scope of § 2.104. This
supplementary notice of hearing will
provide that any person whose interest
may be affected by the proceeding and
who desires to participate as a party in
the resolution of the remaining issues
shall file a petition for leave to intervene
pursuant to § 2.309 within the time
prescribed in the notice. This
supplementary notice will also provide
appropriate opportunities for
participation by a representative of an
interested State under § 2.315(c) and for
limited appearances under § 2.315(a).
(c) Any person who was permitted to
intervene as a party under the initial
notice of hearing on site suitability
issues and who was not dismissed or
did not withdraw as a party may
continue to participate as a party to the
proceeding without having to
demonstrate standing under § 2.309(d),
provided, however, that within the time
prescribed for filing of petitions for
leave to intervene in the supplementary
notice of hearing, the party files a notice
of intent to continue as a party. The
notice must include the information
required by § 2.309(f). A party who files
a non-timely notice of intent to continue
as a party may be dismissed from the
proceeding, absent a determination that
the party has made a substantial
showing of good cause for failure to file
on time, and with particular reference to
the factors specified in §§ 2.309(c)(1)(i)
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through (iv) and 2.309(d). The notice
will be ruled upon by the Commission
or presiding officer designated to rule
on petitions for leave to intervene.
(d) To the maximum extent
practicable, the presiding officer (as
applicable, the membership of the
licensing board) designated to preside in
the proceeding on the remaining
unresolved issues pursuant to the
supplemental notice of hearing will be
the same as the presiding officer (as
applicable, the membership of the
licensing board) designated to preside in
the initial notice of hearing on site
suitability issues.
rwilkins on PROD1PC63 with RULES2
§ 2.625
Additional considerations.
(a) The Commission will not conduct
more than one review of site suitability
issues with regard to a particular site
prior to filing and review of part two of
the application described in § 2.101(a–1)
of this part.
(b) The Commission, upon its own
initiative, or upon the motion of any
party to the proceeding filed at least 60
days prior to the date of the
commencement of the evidentiary
hearing on site suitability issues, may
decline to initiate an early hearing or
render an early partial decision on any
issue or issues of site suitability:
(1) In cases where no partial decision
on the relative merits of the proposed
site and alternative sites under subpart
A of part 51 is requested, upon
determination that there is a reasonable
likelihood that further review would
identify one or more preferable
alternative sites and the partial decision
on one or more site suitability issues
would lead to an irreversible and
irretrievable commitment of resources
prior to the submittal of the remainder
of the information required by § 50.30(f)
of this chapter that would prejudice the
later review and decision on such
alternative sites; or
(2) In cases where it appears that an
early partial decision on any issue or
issues of site suitability would not be in
the public interest considering:
(i) The degree of likelihood that any
early findings on those issues would
retain their validity in later reviews;
(ii) The objections, if any, of cognizant
State or local government agencies to
the conduct of an early review on those
issues; and
(iii) The possible effect on the public
interest and the parties of having an
early, if not necessarily conclusive,
resolution of those issues.
§ 2.627 Partial decision on site suitability
issues in combined license proceeding.
(a) The provisions of §§ 2.331, 2.339,
2.340(b), 2.343, 2.712, and 2.713 shall
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apply to any partial initial decision
rendered in accordance with this
subpart. Section 2.340(c) shall not apply
to any partial initial decision rendered
in accordance with this subpart. A
limited work authorization may not be
issued under 10 CFR 50.10(e) and no
construction permit may be issued
without completion of the full review
required by Section 102(2) of the
National Environmental Policy Act of
1969, as amended, and subpart A of part
51 of this chapter. The authority of the
Commission to review such a partial
initial decision sua sponte, or to raise
sua sponte an issue that has not been
raised by the parties, will be exercised
within the same time period as in the
case of a full decision relating to the
issuance of a construction permit.
(b)(1) A partial decision on one or
more site suitability issues pursuant to
the applicable provisions of part 50,
subpart A of part 51, and part 100 of this
chapter issued in accordance with this
subpart shall:
(i) Clearly identify the site to which
the partial decision applies; and
(ii) Indicate to what extent additional
information may be needed and
additional review may be required to
enable the Commission to determine in
accordance with the provisions of the
Act and the applicable provisions of the
regulations in this chapter whether a
construction permit for a facility to be
located on the site identified in the
partial decision should be issued or
denied.
(2) Following either the Commission
(acting in the function of a presiding
officer) issuance of a partial initial
decision, or completion of Commission
review of the partial initial decision of
the presiding officer, after hearing, on
the site suitability issues, the partial
decision shall remain in effect either for
a period of 5 years or, where the
applicant for the combined license has
made timely submittal of the
information required to support the
application as provided in § 2.101(a–2),
until the proceeding for a combined
license on the site identified in the
partial decision has been concluded,
unless the Commission or presiding
officer, upon its own initiative or upon
motion by a party to the proceeding,
finds that there exists significant new
information that substantially affects the
earlier conclusions and reopens the
hearing record on site suitability issues.
Upon good cause shown, the
Commission may extend the 5-year
period during which a partial decision
shall remain in effect for a reasonable
period of time not to exceed 1 year.
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§ 2.629 Finality of partial decision on site
suitability issues in a combined license
proceeding.
(a) The partial decision on site
suitability issues in a combined license
proceeding shall be incorporated in the
decision regarding issuance of a
combined license. Except as provided in
10 CFR 2.758, in making the findings
required for issuance of a combined
license, the Commission shall treat as
resolved those matters resolved in
connection with the issuance of the
partial decision on site suitability
issues. If the Commission reaches an
adverse decision, the application shall
be denied without prejudice for
resubmission, provided, however, that
in determining whether the resubmitted
application is complete and acceptable
for docketing under § 2.101(a)(3), the
Director of the Office of New Reactors
or the Director of the Office of Nuclear
Reactor Regulation, as appropriate, shall
determine whether the resubmitted
application addresses those matters
identified as bases for denial of the
original application.
(b) Notwithstanding any provision in
10 CFR 50.109, while a partial decision
on site suitability is in effect under
§ 2.617(b)(2), the Commission may not
modify, rescind, or impose new
requirements with respect to matters
within the scope of the site suitability
decision, whether on its own motion, or
in response to a request or petition from
any person, unless the Commission
determines that a modification to the
original decision is necessary either for
compliance with the Commission’s
regulations applicable and in effect at
the time the partial decision was issued,
or to assure adequate protection of the
public health and safety or the common
defense and security.
I 32. Section 2.800 is revised to read as
follows:
§ 2.800
Scope and applicability.
(a) This subpart governs the issuance,
amendment, and repeal of regulations in
which participation by interested
persons is prescribed under Section 553
of title 5 of the U.S. Code.
(b) The procedures in §§ 2.804
through 2.810 apply to all rulemakings.
(c) The procedures in §§ 2.802
through 2.803 apply to all petitions for
rulemaking except for initial
applications for standard design
certification rulemaking under subpart
B of part 52 of this chapter, and
subsequent petitions for amendment of
an existing design certification rule filed
by the original applicant for the design
certification rule.
(d) The procedures in §§ 2.811
through 2.819, as supplemented by the
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provisions of subpart B of part 52, apply
to standard design certification
rulemaking.
I 33. Section 2.801 is revised to read as
follows:
§ 2.801
Initiation of rulemaking.
Rulemaking may be initiated by the
Commission at its own instance, on the
recommendation of another agency of
the United States, or on the petition of
any other interested person, including
an application for design certification
under subpart B of part 52 of this
chapter.
I 34. In subpart H, §§ 2.811, 2.813,
2.815, 2.817 and 2.819 are added to read
as follows:
rwilkins on PROD1PC63 with RULES2
§ 2.811 Filing of standard design
certification application; required copies.
(a) Serving of applications. The signed
original of an application for a standard
design certification, including all
amendments to the applications, must
be sent either by mail addressed: ATTN:
Document Control Desk, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555–0001; by facsimile; by hand
delivery to the NRC’s offices at 11555
Rockville Pike, Rockville, Maryland,
between the hours of 7:30 a.m. and 4:15
p.m. eastern time; or, where practicable,
by electronic submission, for example,
via Electronic Information Exchange, email, or CD–ROM. Electronic
submissions must be made in a manner
that enables the NRC to receive, read,
authenticate, distribute, and archive the
submission, and process and retrieve it
a single page at a time. Detailed
guidance on making electronic
submissions can be obtained by visiting
the NRC’s Web site at https://
www.nrc.gov/site-help/esubmittals.html, by calling (301) 415–
0439, by e-mail at EIE@nrc.gov, or by
writing the Office of Information
Services, U.S. Nuclear Regulatory
Commission, Washington, DC 20555–
0001. The guidance discusses, among
other topics, the formats the NRC can
accept, the use of electronic signatures,
and the treatment of nonpublic
information. If the communication is on
paper, the signed original must be sent.
(b) Form of application. Each original
of an application and an amendment of
an application must meet the
requirements in § 2.813.
(c) Capability to provide additional
copies. The applicant shall maintain the
capability to generate additional copies
of the general information and the safety
analysis report, or part thereof or
amendment thereto, for subsequent
distribution in accordance with the
written instructions of the Director,
Office of New Reactors, the Director,
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Office of Nuclear Reactor Regulation, or
the Director, Office of Nuclear Material
Safety and Safeguards, as appropriate.
(d) Public hearing copy. In any
hearing conducted under subpart O of
this part for a design certification
rulemaking, the applicant must make a
copy of the updated application
available at the public hearing for the
use of any other parties to the
proceeding, and shall certify that the
updated copies of the application
contain the current contents of the
application submitted in accordance
with the requirements of this part.
(e) Pre-application consultation. A
prospective applicant for a standard
design certification may consult with
the NRC before filing an application by
writing to the Director, Division of New
Reactor Licensing, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555–0001, with respect to the
subject matters listed in § 2.802(a)(1)(i)
through (iii) of this chapter. A
prospective petitioner also may
telephone the Rulemaking, Directives,
and Editing Branch on (301) 415–7163,
or toll free on (800) 368–5642, or send
e-mail to NRCREP@nrc.gov on these
subject matters. In addition, a
prospective applicant may confer
informally with the NRC staff BEFORE
filing an application for a standard
design certification, and the limitations
in § 2.802(a)(2) do not apply.
§ 2.813
Written communications.
(a) General requirements. All
correspondence, reports, and other
written communications from the
applicant to the Nuclear Regulatory
Commission concerning the regulations
in this subpart, and parts 50, 52, and
100 of this chapter must be sent either
by mail addressed: ATTN: Document
Control Desk, U.S. Nuclear Regulatory
Commission, Washington, DC 20555–
0001; by hand delivery to the NRC’s
offices at 11555 Rockville Pike,
Rockville, Maryland, between the hours
of 7:30 a.m. and 4:15 p.m. eastern time;
or, where practicable, by electronic
submission, for example, via Electronic
Information Exchange, e-mail, or CD–
ROM. Electronic submissions must be
made in a manner that enables the NRC
to receive, read, authenticate, distribute,
and archive the submission, and process
and retrieve it a single page at a time.
Detailed guidance on making electronic
submissions can be obtained by visiting
the NRC’s Web site at https://
www.nrc.gov/site-help/esubmittals.html, by calling (301) 415–
0439, by e-mail at EIE@nrc.gov, or by
writing the Office of Information
Services, U.S. Nuclear Regulatory
Commission, Washington, DC 20555–
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0001. The guidance discusses, among
other topics, the formats the NRC can
accept, the use of electronic signatures,
and the treatment of nonpublic
information. If the communication is on
paper, the signed original must be sent.
If a submission due date falls on a
Saturday, Sunday, or Federal holiday,
the next Federal working day becomes
the official due date.
(b) Form of communications. All
paper copies submitted to meet the
requirements set forth in paragraph (a)
of this section must be typewritten,
printed or otherwise reproduced in
permanent form on unglazed paper.
Exceptions to these requirements
imposed on paper submissions may be
granted for the submission of
micrographic, photographic, or similar
forms.
(c) Regulation governing submission.
An applicant submitting
correspondence, reports, and other
written communications under the
regulations of this chapter is requested
but not required to cite whenever
practical, in the upper right corner of
the first page of the submission, the
specific regulation or other basis
requiring submission.
§ 2.815
Docketing and acceptance review.
(a) Each application for a standard
design certification will be assigned a
docket number. However, to allow a
determination as to whether an
application is complete and acceptable
for docketing, it will be initially treated
as a tendered application. A copy of the
tendered application will be available
for public inspection at the NRC Web
site, https://www.nrc.gov, and/or at the
NRC Public Document Room. Generally,
the determination on acceptability for
docketing will be made within a period
of 30 days. The Commission may decide
to determine acceptability on the basis
of the technical adequacy of the
application as well as its completeness.
(b) If the Commission determines that
a tendered application is complete and
acceptable for docketing, a docket
number will be assigned to the
application or part thereof, and the
applicant will be notified of the
determination.
§ 2.817
Withdrawal of application.
(a) The Commission may permit an
applicant to withdraw an application for
a standard design certification before
the issuance of a notice of proposed
rulemaking on such terms and
conditions as the Commission may
prescribe, or may, on receiving a request
for withdrawal of an application, deny
the application or dismiss it without
prejudice. The NRC will publish in the
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Federal Register a document
withdrawing the application, if the
notice of receipt of the application, an
advance notice of proposed rulemaking,
or a notice of proposed rulemaking for
the standard design certification has
been previously published in the
Federal Register. If the notice of receipt,
advance notice of proposed rulemaking
or notice of proposed rulemaking was
published on the NRC Web site, then
the notice of action on the withdrawal
will also be published on the NRC Web
site.
(b) The withdrawal of an application
does not authorize the removal of any
document from the files of the
Commission.
§ 2.819 Denial of application for failure to
supply information.
(a) The Commission may deny an
application for a standard design
certification if an applicant fails to
respond to a request for additional
information within 30 days from the
date of the request, or within such other
time as may be specified.
(b) If the Commission denies an
application because the applicant has
failed to respond in a timely fashion to
a request for additional information, the
NRC will publish in the Federal
Register a notice of denial and will
notify the applicant with a simple
statement of the grounds of denial. If a
notice of receipt of application, advance
notice of proposed rulemaking, or notice
of proposed rulemaking for a standard
design certification was published on
the NRC Web site, then the notice of
action on the denial will also be
published on the NRC Web site.
35. In § 2.1202, paragraph (a) is
revised to read as follows:
I
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§ 2.1202
Authority and role of NRC staff.
(a) During the pendency of any
hearing under this subpart, consistent
with the NRC staff’s findings in its
review of the application or matter
which is the subject of the hearing and
as authorized by law, the NRC staff is
expected to issue its approval or denial
of the application promptly, or take
other appropriate action on the
underlying regulatory matter for which
a hearing was provided. When the NRC
staff takes its action, it shall notify the
presiding officer and the parties to the
proceeding of its action. That notice
must include the NRC staff’s position on
the matters in controversy before the
presiding officer with respect to the staff
action. The NRC staff’s action on the
matter is effective upon issuance by the
staff, except in matters involving:
(1) An application to construct and/or
operate a production or utilization
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facility (including an application for a
limited work authorization under 10
CFR 50.12, or an application for a
combined license under subpart C of 10
CFR part 52);
(2) An application for an early site
permit under subpart A of 10 CFR part
52;
(3) An application for a
manufacturing license under subpart F
of 10 CFR part 52;
(4) An application for an amendment
to a construction authorization for a
high-level radioactive waste repository
at a geologic repository operations area
falling under either 10 CFR 60.32(c)(1)
or 10 CFR part 63;
(5) An application for the
construction and operation of an
independent spent fuel storage
installation (ISFSI) located at a site
other than a reactor site or a monitored
retrievable storage installation (MRS)
under 10 CFR part 72; and
(6) Production or utilization facility
licensing actions that involve significant
hazards considerations as defined in 10
CFR 50.92.
*
*
*
*
*
§ 2.1211
I
[Removed]
36. Section 2.1211 is removed.
PART 10—CRITERIA AND
PROCEDURES FOR DETERMINING
ELIGIBILITY FOR ACCESS TO
RESTRICTED DATA OR NATIONAL
SECURITY INFORMATION OR AN
EMPLOYMENT CLEARANCE
37. The authority citation for part 10
continues to read as follows:
I
Authority: Secs. 145, 161, 68 Stat. 942,
948, as amended (42 U.S.C. 2165, 2201); sec.
201, 88 Stat. 1242, as amended (42 U.S.C.
5841); E.O. 10450, 3 CFR parts 1949–1953
COMP., p. 936, as amended; E.O. 10865, 3
CFR 1959–1963 COMP., p. 398, as amended;
3 CFR Table 4; E.O. 12968, 3 CFR 1995
COM., p. 396.
38. In § 10.1, paragraphs (a)(1) and
(a)(2) are revised and paragraph (a)(3) is
added to read as follows:
I
§ 10.1
Purpose.
(a) * * *
(1) The eligibility of individuals who
are employed by or applicants for
employment with NRC contractors,
agents, and other individuals who are
NRC employees or applicants for NRC
employment, and other persons
designated by the Deputy Executive
Director for Information Services and
Administration and Chief Information
Officer of the NRC, for access to
Restricted Data under the Atomic
Energy Act of 1954, as amended, and
the Energy Reorganization Act of 1974,
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49483
or for access to national security
information;
(2) The eligibility of NRC employees,
or the eligibility of applicants for
employment with the NRC, for
employment clearance; and
(3) The eligibility of individuals who
are employed by or are applicants for
employment with NRC licensees,
certificate holders, holders of standard
design approvals under part 52 of this
chapter, applicants for licenses,
certificates, and NRC approvals, and
others who may require access related to
a license, certificate, or NRC approval,
or other activities as the Commission
may determine, for access to Restricted
Data under the Atomic Energy Act of
1954, as amended, and the Energy
Reorganization Act of 1974, or for access
to national security information.
*
*
*
*
*
I 39. In § 10.2, paragraph (b) is revised
to read as follows:
§ 10.2
Scope.
*
*
*
*
*
(b) NRC licensees, certificate holders
and holders of standard design
approvals under part 52 of this chapter,
applicants for licenses, certificates, and
standard design approvals under part 52
of this chapter, and their employees
(including consultants) and applicants
for employment (including consulting);
*
*
*
*
*
PART 19—NOTICES, INSTRUCTIONS
AND REPORTS TO WORKERS;
INSPECTION AND INVESTIGATIONS
40. The authority citation for part 19
is revised to read as follows:
I
Authority: Secs. 53, 63, 81, 103, 104, 161,
186, 68 Stat. 930, 933, 935, 936, 937, 948,
955, as amended, sec. 234, 83 Stat. 444, as
amended, sec. 1701, 106 Stat. 2951, 2952,
2953 (42 U.S.C. 2073, 2093, 2111, 2133, 2134,
2201, 2236, 2282, 2297f); sec. 201, 88 Stat.
1242, as amended (42 U.S.C. 5841); Pub. L.
95–601, sec. 10, 92 Stat. 2951 (42 U.S.C.
5851); sec. 1704, 112 Stat. 2750 (44 U.S.C.
3504 note).
Section 19.32 is also issued under sec. 401,
88 Stat. 1254 (42 U.S.C. 2000d, 42 U.S.C.
5891).
41. Section 19.1 is revised to read as
follows:
I
§ 19.1
Purpose.
The regulations in this part establish
requirements for notices, instructions,
and reports by licensees and regulated
entities to individuals participating in
NRC-licensed and regulated activities
and options available to these
individuals in connection with
Commission inspections of licensees
and regulated entities, and to ascertain
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compliance with the provisions of the
Atomic Energy Act of 1954, as amended,
titles II and IV of the Energy
Reorganization Act of 1974, and
regulations, orders, and licenses
thereunder. The regulations in this part
also establish the rights and
responsibilities of the Commission and
individuals during interviews
compelled by subpoena as part of
agency inspections or investigations
under Section 161c of the Atomic
Energy Act of 1954, as amended, on any
matter within the Commission’s
jurisdiction.
42. Section 19.2 is revised to read as
follows:
I
§ 19.2
Scope.
rwilkins on PROD1PC63 with RULES2
(a) The regulations in this part apply
to:
(1) All persons who receive, possess,
use, or transfer material licensed by the
NRC under the regulations in parts 30
through 36, 39, 40, 60, 61, 63, 70, or 72
of this chapter, including persons
licensed to operate a production or
utilization facility under parts 50 or 52
of this chapter, persons licensed to
possess power reactor spent fuel in an
independent spent fuel storage
installation (ISFSI) under part 72 of this
chapter, and in accordance with 10 CFR
76.60 to persons required to obtain a
certificate of compliance or an approved
compliance plan under part 76 of this
chapter;
(2) All applicants for and holders of
licenses (including construction permits
and early site permits) under parts 50,
52, and 54 of this chapter;
(3) All applicants for and holders of
a standard design approval under
subpart E of part 52 of this chapter; and
(4) All applicants for a standard
design certification under subpart B of
part 52 of this chapter, and those
(former) applicants whose designs have
been certified under that subpart.
(b) The regulations in this part
regarding interviews of individuals
under subpoena apply to all
investigations and inspections within
the jurisdiction of the NRC other than
those involving NRC employees or NRC
contractors. The regulations in this part
do not apply to subpoenas issued under
10 CFR 2.702.
I 43. In § 19.3 the definitions of License
and Worker are revised, and the
definitions of Regulated entities and
Regulated activities are added to read as
follows:
§ 19.3
Definitions.
*
*
*
*
*
License means a license issued under
the regulations in parts 30 through 36,
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39, 40, 60, 61, 63, 70, or 72 of this
chapter, including licenses to
manufacture, construct and/or operate a
production or utilization facility under
parts 50, 52, or 54 of this chapter.
*
*
*
*
*
Regulated activities means any
activity carried on which is under the
jurisdiction of the NRC under the
Atomic Energy Act of 1954, as amended,
or any title of the Energy Reorganization
Act of 1972, as amended.
Regulated entities means any
individual, person, organization, or
corporation that is subject to the
regulatory jurisdiction of the NRC,
including (but not limited to) an
applicant for or holder of a standard
design approval under subpart E of part
52 of this chapter or a standard design
certification under subpart B of part 52
of this chapter.
*
*
*
*
*
Worker means an individual engaged
in activities licensed or regulated by the
Commission and controlled by a
licensee or regulated entity, but does not
include the licensee or regulated entity.
44. In § 19.11, paragraph (c) is
removed and reserved, and the
introductory text of paragraph (a),
paragraphs (b), (d), and (e) are revised,
and paragraphs (f) and (g) are added to
read as follows:
I
§ 19.11
Posting of notices to workers.
(a) Each licensee (except for a holder
of an early site permit under subpart A
of part 52 of this chapter, or a holder of
a manufacturing license under subpart F
of part 52 of this chapter) shall post
current copies of the following
documents:
*
*
*
*
*
(b) Each applicant for and holder of a
standard design approval under subpart
E of part 52 of this chapter, each
applicant for an early site permit under
subpart A of part 52 of this chapter,
each applicant for a standard design
certification under subpart B of part 52
of this chapter, and each applicant for
and holder of a manufacturing license
under subpart F of part 52 of this
chapter shall post:
(1) The regulations in this part;
(2) The operating procedures
applicable to the activities regulated by
the NRC which are being conducted by
the applicant or holder; and
(3) Any notice of violation, proposed
imposition of civil penalty, or order
issued under subpart B of part 2 of this
chapter, and any response from the
applicant or holder.
(c) [Reserved]
(d) If posting of a document specified
in paragraphs (a)(1), (2) or (3), or (b)(1)
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or (2) of this section is not practicable,
the licensee or regulated entity may post
a notice which describes the document
and states where it may be examined.
(e)(1) Each licensee, each applicant
for a specific license, each applicant for
or holder of a standard design approval
under subpart E of part 52 of this
chapter, each applicant for an early site
permit under subpart A of part 52 of this
chapter, and each applicant for a
standard design certification under
subpart B of part 52 of this chapter shall
prominently post NRC Form 3, ‘‘Notice
to Employees,’’ dated August 1997.
Later versions of NRC Form 3 that
supersede the August 1997 version shall
replace the previously posted version
within 30 days of receiving the revised
NRC Form 3 from the Commission.
(2) Additional copies of NRC Form 3
may be obtained by writing to the
Regional Administrator of the
appropriate U.S. Nuclear Regulatory
Commission Regional Office listed in
appendix D to part 20 of this chapter, by
calling (301) 415–7232, via e-mail to
forms@nrc.gov, or by visiting the NRC’s
Web site at https://www.nrc.gov and
selecting forms from the index found on
the home page.
(f) Documents, notices, or forms
posted under this section shall appear
in a sufficient number of places to
permit individuals engaged in NRClicensed or regulated activities to
observe them on the way to or from any
particular licensed or regulated activity
location to which the document applies,
shall be conspicuous, and shall be
replaced if defaced or altered.
(g) Commission documents posted
under paragraphs (a)(4) or (b)(3) of this
section shall be posted within 2 working
days after receipt of the documents from
the Commission; the licensee’s or
regulated entity’s response, if any, shall
be posted within 2 working days after
dispatch by the licensee or regulated
entity. These documents shall remain
posted for a minimum of 5 working days
or until action correcting the violation
has been completed, whichever is later.
45. Section 19.14 is revised to read as
follows:
I
§ 19.14 Presence of representatives of
licensees and regulated entities, and
workers during inspections.
(a) Each licensee, applicant for a
license, applicant for or holder of a
standard design approval under subpart
E of part 52 of this chapter, applicant for
an early site permit under subpart A of
part 52 of this chapter, and applicant for
a standard design certification under
subpart B of part 52 of this chapter shall
afford to the Commission at all
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reasonable times opportunity to inspect
materials, activities, facilities, premises,
and records under the regulations in
this chapter.
(b) During an inspection, Commission
inspectors may consult privately with
workers as specified in § 19.15. The
licensee, regulated entity, or the
licensee’s or regulated entity’s
representative may accompany
Commission inspectors during other
phrases of an inspection.
(c) If, at the time of inspection, an
individual has been authorized by the
workers to represent them during
Commission inspections, the licensee or
regulated entity shall notify the
inspectors of such authorization and
shall give the workers’ representative an
opportunity to accompany the
inspectors during the inspection of
physical working conditions.
(d) Each workers’ representative shall
be routinely engaged in NRC-licensed or
regulated activities under control of the
licensee or regulated entity, and shall
have received instructions as specified
in § 19.12.
(e) Different representatives of
licensees or regulated entities, and
workers may accompany the inspectors
during different phases of an inspection
if there is no resulting interference with
the conduct of the inspection. However,
only one workers’ representative at a
time may accompany the inspectors.
(f) With the approval of the licensee
or regulated entity, and the workers’
representative an individual who is not
routinely engaged in licensed or
regulated activities under control of the
license or regulated entity (for example,
a consultant to the licensee, the
regulated entity, or the workers’
representative), shall be afforded the
opportunity to accompany Commission
inspectors during the inspection of
physical working conditions.
(g) Notwithstanding the other
provisions of this section, Commission
inspectors are authorized to refuse to
permit accompaniment by any
individual who deliberately interferes
with a fair and orderly inspection. With
regard to areas containing information
classified by an agency of the U.S.
Government in the interest of national
security, an individual who
accompanies an inspector may have
access to such information only if
authorized to do so. With regard to any
area containing proprietary information,
the workers’ representative for that area
shall be an individual previously
authorized by the licensee or regulated
entity to enter that area.
§ 19.20
46. Section 19.20 is revised to read as
follows:
I
I
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Employee protection.
§ 20.1002
Employment discrimination by a
licensee, a holder of a certificate of
compliance issued under part 76 of this
chapter or regulated entity subject to the
requirements in this part as delineated
in § 19.2(a), or a contractor or
subcontractor of a licensee, a holder of
a certificate of compliance issued under
part 76 of this chapter, or regulated
entity subject to the requirements in this
part as delineated in § 19.2(a), against an
employee for engaging in protected
activities under this part or parts 30, 40,
50, 52, 54, 60, 61, 63, 70, 72, 76, or 150
of this chapter is prohibited.
47. Section 19.31 is revised to read as
follows:
I
§ 19.31
Application for exemptions.
The Commission may, upon
application by any interested person or
upon its own initiative, grant such
exemptions from the requirements of
the regulations in this part as it
determines are authorized by law, will
not result in undue hazard to life and
property.
48. Section 19.32 is revised to read as
follows:
I
§ 19.32
Discrimination prohibited.
No person shall on the grounds of sex
be excluded from participation in, be
denied a license, be denied the benefit
of, or be subjected to discrimination
under any program or activity carried on
which is under the jurisdiction of the
NRC under the Atomic Energy Act of
1954, as amended, or under any title of
the Energy Reorganization Act of 1974,
as amended. This provision will be
enforced through agency provisions and
regulations similar to those already
established, with respect to racial and
other discrimination, under Title VI of
the Civil Rights Act of 1964. This
remedy is not exclusive, however, and
will not prejudice or cut off any other
legal remedies available to a
discriminatee.
PART 20—STANDARDS FOR
PROTECTION AGAINST RADIATION
49. The authority citation for Part 20
continues to read as follows:
I
Authority: Secs. 53, 63, 65, 81, 103, 104,
161, 182, 186, 68 Stat. 930, 933, 935, 936,
937, 948, 953, 955, as amended, sec. 1701,
106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073,
2093, 2095, 2111, 2133, 2134, 2201, 2232,
2236, 2297f), secs. 201, as amended, 202,
206, 88 Stat. 1242, as amended, 1244, 1246
(42 U.S.C. 5841, 5842, 5846); sec. 1704, 112
Stat. 2750 (44 U.S.C. 3504 note).
50. Section 20.1002 is revised to read
as follows:
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49485
Scope.
The regulations in this part apply to
persons licensed by the Commission to
receive, possess, use, transfer, or
dispose of byproduct, source, or special
nuclear material or to operate a
production or utilization facility under
parts 30 through 36, 39, 40, 50, 52, 60,
61, 63, 70, or 72 of this chapter, and in
accordance with 10 CFR 76.60 to
persons required to obtain a certificate
of compliance or an approved
compliance plan under part 76 of this
chapter. The limits in this part do not
apply to doses due to background
radiation, to exposure of patients to
radiation for the purpose of medical
diagnosis or therapy, to exposure from
individuals administered radioactive
material and released under § 35.75, or
to exposure from voluntary
participation in medical research
programs.
I 51. In § 20.1401 paragraph (a) is
revised to read as follows:
§ 20.1401
General provisions and scope.
(a) The criteria in this subpart apply
to the decommissioning of facilities
licensed under parts 30, 40, 50, 52, 60,
61, 63, 70, and 72 of this chapter, and
release of part of a facility or site for
unrestricted use in accordance with
§ 50.83 of this chapter, as well as other
facilities subject to the Commission’s
jurisdiction under the Atomic Energy
Act of 1954, as amended, and the
Energy Reorganization Act of 1974, as
amended. For high-level and low-level
waste disposal facilities (10 CFR parts
60, 61, and 63), the criteria apply only
to ancillary surface facilities that
support radioactive waste disposal
activities. The criteria do not apply to
uranium and thorium recovery facilities
already subject to appendix A to 10 CFR
part 40 or the uranium solution
extraction facilities.
*
*
*
*
*
I 52. Section 20.1406 is revised to read
as follows:
§ 20.1406
Minimization of contamination.
(a) Applicants for licenses, other than
early site permits and manufacturing
licenses under part 52 of this chapter
and renewals, whose applications are
submitted after August 20, 1997, shall
describe in the application how facility
design and procedures for operation
will minimize, to the extent practicable,
contamination of the facility and the
environment, facilitate eventual
decommissioning, and minimize, to the
extent practicable, the generation of
radioactive waste.
(b) Applicants for standard design
certifications, standard design
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approvals, and manufacturing licenses
under part 52 of this chapter, whose
applications are submitted after August
20, 1997, shall describe in the
application how facility design will
minimize, to the extent practicable,
contamination of the facility and the
environment, facilitate eventual
decommissioning, and minimize, to the
extent practicable, the generation of
radioactive waste.
53. In § 20.2203, paragraphs (c) and
(d) are revised to read as follows:
I
*
*
*
*
(c) For holders of an operating license
or a combined license for a nuclear
power plant, the occurrences included
in paragraph (a) of this section must be
reported in accordance with the
procedures described in §§ 50.73(b), (c),
(d), (e), and (g) of this chapter, and must
include the information required by
paragraph (b) of this section.
Occurrences reported in accordance
with § 50.73 of this chapter need not be
reported by a duplicate report under
paragraph (a) of this section.
(d) All licensees, other than those
holding an operating license or a
combined license for a nuclear power
plant, who make reports under
paragraph (a) of this section shall
submit the report in writing either by
mail addressed to the U.S. Nuclear
Regulatory Commission, ATTN:
Document Control Desk, Washington,
DC 20555–0001; by hand delivery to the
NRC’s offices at 11555 Rockville Pike,
Rockville, Maryland; or, where
practicable, by electronic submission,
for example, Electronic Information
Exchange, or CD–ROM. Electronic
submissions must be made in a manner
that enables the NRC to receive, read,
authenticate, distribute, and archive the
submission, and process and retrieve it
a single page at a time. Detailed
guidance on making electronic
submissions can be obtained by visiting
the NRC’s Web site at https://
www.nrc.gov/site-help/esubmittals.html, by calling (301) 415–
0439, by e-mail to EIE@nrc.gov, or by
writing the Office of Information
Services, U.S. Nuclear Regulatory
Commission, Washington, DC 20555–
0001. A copy should be sent to the
appropriate NRC Regional Office listed
in appendix D to this part.
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*
PART 21—REPORTING OF DEFECTS
AND NONCOMPLIANCE
54. The authority citation for part 21
continues to read as follows:
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55. In § 21.2, paragraphs (a), (b), and
(c) are revised to read as follows:
I
§ 21.2
§ 20.2203 Reports of exposures, radiation
levels, and concentrations of radioactive
material exceeding the constraints or limits.
I
Authority: Sec. 161, 68 Stat. 948, as
amended, sec. 234, 83 Stat. 444, as amended,
sec. 1701, 106 Stat. 2951, 2953 (42 U.S.C.
2201, 2282, 2297f); secs. 201, as amended,
206, 88 Stat. 1242, as amended 1246 (42
U.S.C. 5841, 5846); sec. 1704, 112 Stat. 2750
(44 U.S.C. 3504 note).
Section 21.2 also issued under secs. 135,
141, Pub. L. 97–425, 96 Stat. 2232, 2241 (42
U.S.C. 10155, 10161).
Scope.
(a) The regulations in this part apply,
except as specifically provided
otherwise in parts 31, 34, 35, 39, 40, 60,
61, 63, 70, or part 72 of this chapter, to:
(1) Each individual, partnership,
corporation, or other entity applying for
or holding a license or permit under the
regulations in this chapter to possess,
use, or transfer within the United States
source material, byproduct material,
special nuclear material, and/or spent
fuel and high-level radioactive waste, or
to construct, manufacture, possess, own,
operate, or transfer within the United
States, any production or utilization
facility or independent spent fuel
storage installation (ISFSI) or monitored
retrievable storage installation (MRS);
and each director and responsible
officer of such a licensee;
(2) Each individual, corporation,
partnership, or other entity doing
business within the United States, and
each director and responsible officer of
such an organization, that constructs a
production or utilization facility
licensed for manufacture, construction,
or operation under parts 50 or 52 of this
chapter, an ISFSI for the storage of spent
fuel licensed under part 72 of this
chapter, an MRS for the storage of spent
fuel or high-level radioactive waste
under part 72 of this chapter, or a
geologic repository for the disposal of
high-level radioactive waste under part
60 or 63 of this chapter; or supplies
basic components for a facility or
activity licensed, other than for export,
under parts 30, 40, 50, 52, 60, 61, 63, 70,
71, or part 72 of this chapter;
(3) Each individual, corporation,
partnership, or other entity doing
business within the United States, and
each director and responsible officer of
such an organization, applying for a
design certification rule under part 52 of
this chapter; or supplying basic
components with respect to that design
certification, and each individual,
corporation, partnership, or other entity
doing business within the United States,
and each director and responsible
officer of such an organization, whose
application for design certification has
been granted under part 52 of this
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chapter, or who has supplied or is
supplying basic components with
respect to that design certification;
(4) Each individual, corporation,
partnership, or other entity doing
business within the United States, and
each director and responsible officer of
such an organization, applying for or
holding a standard design approval
under part 52 of this chapter; or
supplying basic components with
respect to a standard design approval
under part 52 of this chapter;
(b) For persons licensed to construct
a facility under either a construction
permit issued under § 50.23 of this
chapter or a combined license under
part 52 of this chapter (for the period of
construction until the date that the
Commission makes the finding under
§ 52.103(g) of this chapter), or to
manufacture a facility under part 52 of
this chapter, evaluation of potential
defects and failures to comply and
reporting of defects and failures to
comply under § 50.55(e) of this chapter
satisfies each person’s evaluation,
notification, and reporting obligation to
report defects and failures to comply
under this part and the responsibility of
individual directors and responsible
officers of these licensees to report
defects under Section 206 of the Energy
Reorganization Act of 1974.
(c) For persons licensed to operate a
nuclear power plant under part 50 or
part 52 of this chapter, evaluation of
potential defects and appropriate
reporting of defects under §§ 50.72,
50.73, or § 73.71 of this chapter, satisfies
each person’s evaluation, notification,
and reporting obligation to report
defects under this part, and the
responsibility of individual directors
and responsible officers of these
licensees to report defects under Section
206 of the Energy Reorganization Act of
1974.
*
*
*
*
*
I 56. In § 21.3 the definitions of basic
component, defect, deviation, and
substantial safety hazard are revised to
read as follows:
§ 21.3
Definitions.
*
*
*
*
*
Basic component. (1)(i) When applied
to nuclear power plants licensed under
10 CFR part 50 or part 52 of this
chapter, basic component means a
structure, system, or component, or part
thereof that affects its safety function
necessary to assure:
(A) The integrity of the reactor coolant
pressure boundary;
(B) The capability to shut down the
reactor and maintain it in a safeshutdown condition; or
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(C) The capability to prevent or
mitigate the consequences of accidents
which could result in potential offsite
exposures comparable to those referred
to in §§ 50.34(a)(1), 50.67(b)(2), or
100.11 of this chapter, as applicable.
(ii) Basic components are items
designed and manufactured under a
quality assurance program complying
with appendix B to part 50 of this
chapter, or commercial grade items
which have successfully completed the
dedication process.
(2) When applied to standard design
certifications under subpart C of part 52
of this chapter and standard design
approvals under part 52 of this chapter,
basic component means the design or
procurement information approved or to
be approved within the scope of the
design certification or approval for a
structure, system, or component, or part
thereof, that affects its safety function
necessary to assure:
(i) The integrity of the reactor coolant
pressure boundary;
(ii) The capability to shut down the
reactor and maintain it in a safeshutdown condition; or
(iii) The capability to prevent or
mitigate the consequences of accidents
which could result in potential offsite
exposures comparable to those referred
to in §§ 50.34(a)(1), 50.67(b)(2), or
100.11 of this chapter, as applicable.
(3) When applied to other facilities
and other activities licensed under 10
CFR parts 30, 40, 50 (other than nuclear
power plants), 60, 61, 63, 70, 71, or 72
of this chapter, basic component means
a structure, system, or component, or
part thereof, that affects their safety
function, that is directly procured by the
licensee of a facility or activity subject
to the regulations in this part and in
which a defect or failure to comply with
any applicable regulation in this
chapter, order, or license issued by the
Commission could create a substantial
safety hazard.
(4) In all cases, basic component
includes safety-related design, analysis,
inspection, testing, fabrication,
replacement of parts, or consulting
services that are associated with the
component hardware, design
certification, design approval, or
information in support of an early site
permit application under part 52 of this
chapter, whether these services are
performed by the component supplier or
others.
*
*
*
*
*
Defect means:
(1) A deviation in a basic component
delivered to a purchaser for use in a
facility or an activity subject to the
regulations in this part if, on the basis
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of an evaluation, the deviation could
create a substantial safety hazard;
(2) The installation, use, or operation
of a basic component containing a
defect as defined in this section;
(3) A deviation in a portion of a
facility subject to the early site permit,
standard design certification, standard
design approval, construction permit,
combined license or manufacturing
licensing requirements of part 50 or part
52 of this chapter, provided the
deviation could, on the basis of an
evaluation, create a substantial safety
hazard and the portion of the facility
containing the deviation has been
offered to the purchaser for acceptance;
(4) A condition or circumstance
involving a basic component that could
contribute to the exceeding of a safety
limit, as defined in the technical
specifications of a license for operation
issued under part 50 or part 52 of this
chapter; or
(5) An error, omission or other
circumstance in a design certification,
or standard design approval that, on the
basis of an evaluation, could create a
substantial safety hazard.
Deviation means a departure from the
technical requirements included in a
procurement document, or specified in
early site permit information, a standard
design certification or standard design
approval.
*
*
*
*
*
Substantial safety hazard means a
loss of safety function to the extent that
there is a major reduction in the degree
of protection provided to public health
and safety for any facility or activity
licensed or otherwise approved or
regulated by the NRC, other than for
export, under parts 30, 40, 50, 52, 60,
61, 63, 70, 71, or 72 of this chapter.
*
*
*
*
*
I 57. Section 21.5 is revised to read as
follows:
§ 21.5
Communications.
Except where otherwise specified in
this part, written communications and
reports concerning the regulations in
this part must be addressed to the NRC’s
Document Control Desk, and sent by
mail to the U.S. Nuclear Regulatory
Commission, Washington, DC 20555–
0001; by hand delivery to the NRC’s
offices at 11555 Rockville Pike,
Rockville, Maryland; or, where
practicable, by electronic submission,
for example, Electronic Information
Exchange, or CD–ROM. Electronic
submissions must be made in a manner
that enables the NRC to receive, read,
authenticate, distribute, and archive the
submission, and process and retrieve it
a single page at a time. Detailed
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49487
guidance on making electronic
submissions can be obtained by visiting
the NRC’s Web site at https://
www.nrc.gov/site-help/eie.html, by
calling (301) 415–6030, by e-mail to
EIE@nrc.gov, or by writing the Office of
Information Services, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555–0001. The guidance
discusses, among other topics, the
formats the NRC can accept, the use of
electronic signatures, and the treatment
of nonpublic information. In the case of
a licensee or permit holder, a copy of
the communication must also be sent to
the appropriate Regional Administrator
at the address specified in appendix D
to part 20 of this chapter.
I 58. In § 21.21 the introductory text of
paragraph (a)(3), paragraph (a)(3)(i), and
paragraphs (d)(1)(i), (d)(1)(ii), and
(d)(4)(vi) are revised and paragraph
(d)(4)(ix) is added to read as follows:
§ 21.21 Notification of failure to comply or
existence of a defect and its evaluation.
(a) * * *
(3) Ensure that a director or
responsible officer subject to the
regulations of this part is informed as
soon as practicable, and, in all cases,
within the 5 working days after
completion of the evaluation described
in paragraphs (a)(1) or (a)(2) of this
section if the manufacture, construction,
or operation of a facility or activity, a
basic component supplied for such
facility or activity, or the design
certification or design approval under
part 52 of this chapter—
(i) Fails to comply with the Atomic
Energy Act of 1954, as amended, or any
applicable rule, regulation, order, or
license of the Commission or standard
design approval under part 52 of this
chapter, relating to a substantial safety
hazard, or
*
*
*
*
*
(d)(1) * * *
(i) The manufacture, construction or
operation of a facility or an activity
within the United States that is subject
to the licensing requirements under
parts 30, 40, 50, 52, 60, 61, 63, 70, 71,
or 72 of this chapter and that is within
his or her organization’s responsibility;
or
(ii) A basic component that is within
his or her organization’s responsibility
and is supplied for a facility or an
activity within the United States that is
subject to the licensing, design
certification, or approval requirements
under parts 30, 40, 50, 52, 60, 61, 63, 70,
71, or 72 of this chapter.
*
*
*
*
*
(4) * * *
(vi) In the case of a basic component
which contains a defect or fails to
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comply, the number and location of
these components in use at, supplied
for, being supplied for, or may be
supplied for, manufactured, or being
manufactured for one or more facilities
or activities subject to the regulations in
this part.
*
*
*
*
*
(ix) In the case of an early site permit,
the entities to whom an early site permit
was transferred.
*
*
*
*
*
I 59. In § 21.51 paragraphs (a)(4) and
(a)(5) are added and paragraph (b) is
revised to read as follows:
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§ 21.51 Maintenance and inspection of
records.
(a) * * *
(4) Applicants for standard design
certification under subpart B of part 52
of this chapter and others providing a
design which is the subject of a design
certification, during and following
Commission adoption of a final design
certification rule for that design, shall
retain any notifications sent to
purchasers and affected licensees for a
minimum of 5 years after the date of the
notification, and retain a record of the
purchasers for 15 years after delivery of
design which is the subject of the design
certification rule or service associated
with the design.
(5) Applicants for or holders of a
standard design approval under subpart
E of part 52 of this chapter and others
providing a design which is the subject
of a design approval shall retain any
notifications sent to purchasers and
affected licensees for a minimum of 5
years after the date of the notification,
and retain a record of the purchasers for
15 years after delivery of the design
which is the subject of the design
approval or service associated with the
design.
(b) Each individual, corporation,
partnership, dedicating entity, or other
entity subject to the regulations in this
part shall permit the Commission the
opportunity to inspect records
pertaining to basic components that
relate to the identification and
evaluation of deviations, and the
reporting of defects and failures to
comply, including (but not limited to)
any advice given to purchasers or
licensees on the placement, erection,
installation, operation, maintenance,
modification, or inspection of a basic
component.
I 60. In § 21.61, paragraph (b) is revised
to read as follows:
§ 21.61
holder of, a permit), applicant for a
design certification under part 52 of this
chapter during the pendency of its
application, applicant for a design
certification after Commission adoption
of a final design certification rule for
that design, or applicant for or holder of
a standard design approval under part
52 of this chapter subject to the
regulations in this part who fails to
provide the notice required by § 21.21,
or otherwise fails to comply with the
applicable requirements of this part
shall be subject to a civil penalty as
provided by Section 234 of the Atomic
Energy Act of 1954, as amended.
*
*
*
*
*
PART 25—ACCESS AUTHORIZATION
61. The authority citation for part 25
continues to read as follows:
I
Authority: Secs. 145, 161, 68 Stat. 942,
948, as amended (42 U.S.C. 2165, 2201); sec.
201, 88 Stat. 1242, as amended (42 U.S.C.
5841); sec. 1704, 112 Stat. 2750 (44 U.S.C.
3504 note); E.O. 10865, as amended, 3 CFR
1959–1963 Comp., p. 398 (50 U.S.C. 401,
note); E.O. 12829, 3 CFR, 1993 Comp., p. 570;
E.O. 12958, as amended, 3 CFR, 1995 Comp.,
p. 333 as amended by E.O. 13292, 3 CFR
2004 Comp., p. 196; E.O. 12968, 3 CFR, 1995
Comp., p. 396.
Appendix A also issued under 96 Stat.
1051 (31 U.S.C. 9701).
62. The heading of part 25 is revised
to read as set forth above.
I 63. In § 25.35, paragraph (a) is revised
to read as follows:
I
§ 25.35
Classified visits.
(a) The number of classified visits
must be held to a minimum. The
licensee, certificate holder, applicant for
a standard design certification under
part 52 of this chapter (including an
applicant after the Commission has
adopted a final standard design
certification rule under part 52 of this
chapter), or other facility, or an
applicant for or holder of a standard
design approval under part 52 of this
chapter shall determine that the visit is
necessary and that the purpose of the
visit cannot be achieved without access
to, or disclosure of, classified
information. All classified visits require
advance notification to, and approval of,
the organization to be visited. In urgent
cases, visit information may be
furnished by telephone and confirmed
in writing.
*
*
*
*
*
PART 26—FITNESS FOR DUTY
PROGRAMS
Failure to notify.
*
*
*
*
*
(b) Any NRC licensee or applicant for
a license (including an applicant for, or
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64. The authority citation for part 26
continues to read as follows:
I
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Authority: Secs. 53, 81, 103, 104, 107, 161,
68 Stat. 930, 935, 936, 937, 948, as amended,
sec. 1701, 106 Stat. 2951, 2952, 2953 (42
U.S.C. 2073, 2111, 2112, 2133, 2134, 2137,
2201, 2297f); secs. 201, 202, 206, 88 Stat.
1242, 1244, 1246, as amended (42 U.S.C.
5841, 5842, 5846).
65. In § 26.2, the introductory text of
paragraph (a), and paragraph (c) are
revised to read as follows:
I
§ 26.2
Scope.
(a) The regulations in this part apply
to licensees authorized to operate a
nuclear power reactor, including a
holder of a combined license after the
Commission makes the finding under
§ 52.103(g) of this chapter, and licensees
who are authorized to possess or use
formula quantities of SSNM, or to
transport formula quantities of SSNM.
Each licensee shall implement a fitnessfor-duty program which complies with
this part. The provisions of the fitnessfor-duty program must apply to all
persons granted unescorted access to
nuclear power plant protected areas, to
licensee, vendor, or contractor
personnel required to physically report
to a licensee’s Technical Support Center
(TSC) or Emergency Operations Facility
(EOF) in accordance with licensee
emergency plans and procedures, and to
SSNM licensee and transporter
personnel who:
*
*
*
*
*
(c) Certain regulations in this part
apply to licensees holding permits to
construct a nuclear power plant,
including a holder of a combined
license before the date that the
Commission makes the finding under
§ 52.103(g) of this chapter, holders of
manufacturing licenses under part 52,
and persons authorized to conduct the
activities under § 50.10(e)(3) of this
chapter. Each licensee with a
construction permit, a combined license
before the Commission makes the
finding under § 52.103(g) of this
chapter, a manufacturing license, or
person authorized to conduct the
activities under § 50.10(e)(3) of this
chapter, with a plant or reactor under
active construction or manufacture,
shall—
(1) Comply with §§ 26.10, 26.20,
26.23, 26.70, and 26.73;
(2) Implement a chemical testing
program, including random tests; and
(3) Make provisions for employee
assistance programs, imposition of
sanctions, appeals procedures, the
protection of information, and
recordkeeping.
*
*
*
*
*
I 66. In § 26.10, paragraph (a) is revised
to read as follows:
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§ 26.10
General performance objectives.
*
*
*
*
*
(a) Provide reasonable assurance that
nuclear power plant personnel,
personnel of a holder of a
manufacturing license, personnel of a
person authorized to conduct activities
under § 50.10(e)(3) of this chapter,
transporter personnel, and personnel of
licensees authorized to possess or use
formula quantities of SSNM, will
perform their tasks in a reliable and
trustworthy manner and are not under
the influence of any substance, legal or
illegal, or mentally or physically
impaired from any cause, which in any
way adversely affects their ability to
safely and competently perform their
duties;
*
*
*
*
*
I 67. In Appendix A of Part 26,
paragraph (1) of Section 1.1 of Subpart
A is revised to read as follows:
Appendix A to Part 26—Guidelines for
Drug and Alcohol Testing Programs
1.1 Applicability.
(1) These guidelines apply to licensees
authorized to operate nuclear power reactors,
including a holder of a combined license
after the Commission makes the finding
under § 52.103(g) of this chapter, and
licensees who are authorized to possess, use,
or transport formula quantities of strategic
special nuclear material (SSNM).
*
*
*
*
*
PART 50—DOMESTIC LICENSING OF
PRODUCTION AND UTILIZATION
FACILITIES
68. The authority citation for part 50
continues to read as follows:
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I
Authority: Secs. 102, 103, 104, 105, 161,
182, 183, 186, 189, 68 Stat. 936, 937, 938,
948, 953, 954, 955, 956, as amended, sec.
234, 83 Stat. 444, as amended (42 U.S.C.
2132, 2133, 2134, 2135, 2201, 2232, 2233,
2236, 2239, 2282); secs. 201, as amended,
202, 206, 88 Stat. 1242, as amended, 1244,
1246 (42 U.S.C. 5841, 5842, 5846); sec. 1704,
112 Stat. 2750 (44 U.S.C. 3504 note).
Section 50.7 also issued under Pub. L. 95—
601, sec. 10, 92 Stat. 2951 (42 U.S.C. 5841).
Section 50.10 also issued under secs. 101,
185, 68 Stat. 955, as amended (42 U.S.C.
2131, 2235); sec. 102, Pub. L. 91—190, 83
Stat. 853 (42 U.S.C. 4332). Sections 50.13,
50.54(dd), and 50.103 also issued under sec.
108, 68 Stat. 939, as amended (42 U.S.C.
2138). Sections 50.23, 50.35, 50.55, and 50.56
also issued under sec. 185, 68 Stat. 955 (42
U.S.C. 2235). Sections 50.33a, 50.55a and
appendix Q also issued under sec. 102, Pub.
L. 91—190, 83 Stat. 853 (42 U.S.C. 4332).
Sections 50.34 and 50.54 also issued under
sec. 204, 88 Stat. 1245 (42 U.S.C. 5844).
Sections 50.58, 50.91, and 50.92 also issued
under Pub. L. 97—415, 96 Stat. 2073 (42
U.S.C. 2239). Section 50.78 also issued under
sec. 122, 68 Stat. 939 (42 U.S.C. 2152).
Sections 50.80—50.81 also issued under sec.
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184, 68 Stat. 954, as amended (42 U.S.C.
2234). Appendix F also issued under sec.
187, 68 Stat. 955 (42 U.S.C. 2237).
69. In Section 50.2, definitions of
applicant, license, licensee, and
prototype plant, are added to read as
follows:
I
§ 50.2
Definitions.
*
*
*
*
*
Applicant means a person or an entity
applying for a license, permit, or other
form of Commission permissi