# 68 FR 40026: Early Site Permits, Standard Design Certifications, and Combined Licenses for Nuclear Power Plants

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/FR_PRORULE_03-16413

## Section

- **Citation:** 68 FR 40026
- **Heading:** Early Site Permits, Standard Design Certifications, and Combined Licenses for Nuclear Power Plants
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Federal Register / Vol. 68 / 68 FR 40026

## Text

Part II

Nuclear Regulatory Commission

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10 CFR Part 2, et al.

Early Site Permits, Standard Design Certifications, and Combined
Licenses for Nuclear Power Plants; Proposed Rule

Proposed Rules

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NUCLEAR REGULATORY COMMISSION

10 CFR Parts 2, 20, 21, 50, 51, 52, 72, 73, 140, and 170

RIN 3150-AG24

Early Site Permits, Standard Design Certifications, and Combined
Licenses for Nuclear Power Plants

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC or Commission) is
proposing to amend its requirements for early site permits, standard
design certifications, combined licenses for nuclear power plants, and
for other licensing processes. The amendments are based on the NRC
staff's experience with the previous design certification reviews and
on discussions with stakeholders about the early site permit (ESP),
design certification, and combined license (COL) processes. This action
is expected to improve the effectiveness of the licensing processes for
future applicants.

DATES: Submit comments by September 16, 2003. Comments received after
this date will be considered, if it is practical to do so, but the
Commission is able to ensure consideration only for comments received
on or before this date.
design certification, and combined license (COL) processes. This action
is expected to improve the effectiveness of the licensing processes for
future applicants.

DATES: Submit comments by September 16, 2003. Comments received after
this date will be considered, if it is practical to do so, but the
Commission is able to ensure consideration only for comments received
on or before this date.

ADDRESSES: You may submit comments by any one of the following methods.
Please include the following number RIN 3150-AG24 in the subject line
of your comments. Comments submitted in writing or in electronic form
will be made available to the public in their entirety on the NRC
rulemaking Web site. Personal information will not be removed from your
comments.
Mail comments to: Secretary, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.
E-mail comments to: [email protected]. If you do not receive a reply e-
mail confirming that we have received your comments, contact us
directly at (301) 415-1966. You may also submit comments via the NRC's
rulemaking Web site at http://ruleforum.llnl.gov. Address questions
about our rulemaking Web site to Carol Gallagher (301) 415-5905; email
[email protected].
Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland
20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. (Telephone
(301) 415-1966).
Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at
s via the NRC's
rulemaking Web site at http://ruleforum.llnl.gov. Address questions
about our rulemaking Web site to Carol Gallagher (301) 415-5905; email
[email protected].
Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland
20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. (Telephone
(301) 415-1966).
Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at
(301) 415-1101.
Publicly available documents related to this rulemaking may be
examined and copied for a fee at the NRC's Public Document Room (PDR),
Public File Area O1 F21, One White Flint North, 11555 Rockville Pike,
Rockville, Maryland. Selected documents, including comments, can be
viewed and downloaded electronically via the NRC rulemaking Web site at
http://ruleforum.llnl.gov.
Publicly available documents created or received at the NRC after
November 1, 1999, are available electronically at the NRC's Electronic
Reading Room at http://www.nrc.gov/NRC/ADAMS/index.html. From this
site, the public can gain entry into the NRC's Agencywide Document
Access and Management System (ADAMS), which provides text and image
files of NRC's public documents. If you do not have access to ADAMS or
if there are problems in accessing the documents located in ADAMS,
contact the NRC's PDR Reference staff at 1-800-397-4209, 301-415-4737
or by e-mail to [email protected].

FOR FURTHER INFORMATION CONTACT: Jerry N. Wilson, Office of Nuclear
Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001; telephone (301) 415-3145, email [email protected]; or Nanette V.
Gilles, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, telephone (301) 415-1180, e-mail
[email protected].

SUPPLEMENTARY INFORMATION:
R INFORMATION CONTACT: Jerry N. Wilson, Office of Nuclear
Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001; telephone (301) 415-3145, email [email protected]; or Nanette V.
Gilles, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, telephone (301) 415-1180, e-mail
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background.
II. Reorganization of 10 CFR Part 52.
III. Discussion of Substantive Changes.
A. 10 CFR Part 52, Early Site Permits, Standard Design
Certifications, and Combined Licenses for Nuclear Power Plants.
General Provisions.
Early Site Permits.
Early Site Reviews.
Standard Design Certifications.
Design Certification Backfit Requirement.
Standard Design Approvals.
Combined Licenses.
Referencing an Early Site Permit.
Testing Requirements for Advanced Reactors.
Probabilistic Risk Assessments.
Resolution of ITAAC.
Commission Finding on Acceptance Criteria.
Combined License Change Process.
Design Certifications for ABWR, System 80+, and AP600.
B. 10 CFR Part 2, Rules of Practice for Domestic Licensing
Proceedings and Issuance of Orders.
C. 10 CFR Part 20, Standards for Protection Against Radiation.
D. 10 CFR Part 21, Reporting of Defects and Noncompliance.
E. 10 CFR Part 50, Domestic Licensing of Production and
Utilization Facilities.
F. 10 CFR Part 51, Environmental Protection Regulations for
Domestic Licensing and Related Regulatory Functions.
G. 10 CFR Part 72, Licensing Requirements for the Independent
Storage of Spent Nuclear Fuel and High-Level Radioactive Waste.
H. 10 CFR Part 73, Physical Protection of Plants and Materials.
I. 10 CFR Part 140, Financial Protection Requirements and
Indemnity Agreements.
J. 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.
IV. Specific Requests for Comments.
V. Availability of Documents.
VI. Plain Language.
VII
. 10 CFR Part 73, Physical Protection of Plants and Materials.
I. 10 CFR Part 140, Financial Protection Requirements and
Indemnity Agreements.
J. 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.
IV. Specific Requests for Comments.
V. Availability of Documents.
VI. Plain Language.
VII. Voluntary Consensus Standards.
VIII.Environmental Impact'Categorical Exclusion.
IX. Paperwork Reduction Act Statement.
X. Regulatory Analysis.
XI. Regulatory Flexibility Certification.
XII. Backfit Analysis.

I. Background

The Commission promulgated 10 CFR part 52 on April 18, 1989 (54 FR
15386), to reform the licensing process for future nuclear power plant
applicants. 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 resolve safety and environmental issues early in licensing
proceedings and are intended to enhance the safety and reliability of
nuclear power plants through standardization. The rule also moved the
licensing processes in appendices M, N, O, and Q of 10 CFR part 50 to
10 CFR part 52. Subsequently, the NRC certified three nuclear plant
designs under subpart B of 10 CFR part 52--the U.S. Advanced Boiling
Water Reactor (ABWR) (62 FR 25827, May 12, 1997), System 80+ (62 FR
27867, May 21, 1997), and AP600 (64 FR 72015, December 23, 1999)
designs--and codified these designs in Appendices A, B, and C of 10 CFR
part 52, respectively.
The NRC had planned to update 10 CFR part 52 after using the design
certification process for these three certified standard plant designs
--the U.S. Advanced Boiling
Water Reactor (ABWR) (62 FR 25827, May 12, 1997), System 80+ (62 FR
27867, May 21, 1997), and AP600 (64 FR 72015, December 23, 1999)
designs--and codified these designs in Appendices A, B, and C of 10 CFR
part 52, respectively.
The NRC had planned to update 10 CFR part 52 after using the design
certification process for these three certified standard plant designs.
In addition, discussions with stakeholders at public meetings and
comments on SECY-00-0092, ``Combined License Review Process,'' dated
April 20, 2000, identified licensing issues associated with subparts A
and C of 10 CFR part 52. As a result, the NRC initiated this proposed
rulemaking to (1) clarify and/

or correct 10 CFR parts 2, 20, 21, 50, 51, 52 (including appendices A,
B, and C), 72, 73, 140, and 170; (2) update 10 CFR part 52; and (3)
incorporate stakeholder comments.
This 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 on January 14, 1999, approving the NRC
staff's plan for revising 10 CFR part 52. A notice of the rulemaking
plan was added to the NRC's rulemaking Web site on June 16, 1999. On
September 3, 1999, letters were sent to 10 external stakeholders
alerting them to this proposed rulemaking. In addition, the NRC staff
held three public meetings with interested stakeholders on the 10 CFR
part 52 rulemaking on December 14, 2000, February 16, 2001, and March
7, 2001. Following those meetings, on April 3, 2001, the Nuclear Energy
Institute (NEI) submitted comments on issues discussed during the
meetings.
On September 27, 2001, the NRC staff posted draft rule language for
10 CFR part 52 on the NRC's rulemaking Web site. The NRC received
comments on the draft rule language in November 2001, from General
Electric, Entergy, NEI, Westinghouse Electric, and Exelon Generation
e meetings, on April 3, 2001, the Nuclear Energy
Institute (NEI) submitted comments on issues discussed during the
meetings.
On September 27, 2001, the NRC staff posted draft rule language for
10 CFR part 52 on the NRC's rulemaking Web site. The NRC received
comments on the draft rule language in November 2001, from General
Electric, Entergy, NEI, Westinghouse Electric, and Exelon Generation.
The NRC staff has considered these comments in the development of this
proposed rule and posted revised draft rule language for 10 CFR part 52
on the NRC's rulemaking Web site on February 28, 2002.

II. Reorganization of 10 CFR Part 52

The NRC is proposing to reorganize 10 CFR part 52 to establish a
separate subpart for each of the seven licensing processes currently
described in 10 CFR part 52 (early site permits, early site reviews,
standard design certification, standard design approvals, combined
licenses, manufacturing licenses, and duplicate design licenses). The
purpose of this reorganization is to clarify that each licensing
process has equal standing. In addition, several subparts would be
reserved for future licensing processes. No substantive changes are
intended by the incorporation of current appendices M, N, O, and Q into
the new subparts in 10 CFR Part 52.
The NRC is also proposing to retitle 10 CFR part 52 as ``Additional
Licensing Processes for Nuclear Power Plants,'' to clarify that the
licensing processes in 10 CFR part 52 are in addition to and supplement
the two-step licensing process in 10 CFR part 50 and the license
renewal process in 10 CFR part 54, and are not limited to the early
site permit, standard design certification, and combined license
processes as the current title implies.
The proposed rule would amend Sec. 52.1 to clarify that all seven
licensing processes are within the scope of 10 CFR part 52. Paragraphs
within current Appendices M, N, O, and Q would also become new sections
of the revised part
process in 10 CFR part 54, and are not limited to the early
site permit, standard design certification, and combined license
processes as the current title implies.
The proposed rule would amend Sec. 52.1 to clarify that all seven
licensing processes are within the scope of 10 CFR part 52. Paragraphs
within current Appendices M, N, O, and Q would also become new sections
of the revised part. In addition, the proposed rule would reserve
subparts for future licensing processes. In doing so, the NRC hopes to
convey that 10 CFR part 52 is the preferred location in 10 CFR for
nuclear power plant licensing processes.
The proposed rule would amend Sec. 52.19, the current Sec. 52.49
(proposed Sec. 52.111), and the current Sec. 52.83 (proposed Sec.
52.215) to provide a standard format in subparts A, D, and G. This
standard format would set forth the standards for review of
applications and the applicability of NRC requirements in a consistent
manner in each of these subparts. The references to the part 170 fee
requirements would be moved to be included in the sections on filing of
applications. This reorganization of 10 CFR part 52 will make the
subparts on early site permits and standard design certifications
consistent with the existing arrangement in the subpart for combined
licenses.
The proposed rule would also move the requirement on duration of a
combined license that is currently located in Sec. 52.83,
``Applicability of part 50 provisions,'' to paragraph (e) of proposed
Sec. 52.227, ``Issuance of combined licenses.'' Proposed Sec.
52.227(e) is a more appropriate location for this requirement.
The Commission has prepared the following table that cross-
references the new proposed provisions in 10 CFR part 52 to the
superseded provisions of 10 CFR part 52.
is currently located in Sec. 52.83,
``Applicability of part 50 provisions,'' to paragraph (e) of proposed
Sec. 52.227, ``Issuance of combined licenses.'' Proposed Sec.
52.227(e) is a more appropriate location for this requirement.
The Commission has prepared the following table that cross-
references the new proposed provisions in 10 CFR part 52 to the
superseded provisions of 10 CFR part 52.

Table 1.--Cross-References Between New and Old 10 CFR Part 52
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New section Old section
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General Provisions:
52.1.................................... 52.1
52.3.................................... 52.3
52.5.................................... 52.5
52.8.................................... 52.8
None.................................... 52.9
Subpart A--Early Site Permits:
52.11................................... 52.11
52.13................................... 52.13
52.15................................... 52.15
52.17................................... 52.17
52.18................................... 52.18
52.19................................... 52.19
52.21................................... 52.21
52.23................................... 52.23
52.24................................... 52.24
52.25................................... 52.25
52.27................................... 52.27
52.29................................... 52.29
52.31................................... 52.31
52.33................................... 52.33
52.35................................... 52.35
52.37................................... 52.37
52.39................................... 52.39
Subpart B--Early Site Reviews:
52.41................................... App. Q, Introduction
52.43(a)................................ App. Q, Paragraph 1
52.43(b)................................ App. Q, Paragraph 2
52.43(c)................................ App
.................................. 52.35
52.37................................... 52.37
52.39................................... 52.39
Subpart B--Early Site Reviews:
52.41................................... App. Q, Introduction
52.43(a)................................ App. Q, Paragraph 1
52.43(b)................................ App. Q, Paragraph 2
52.43(c)................................ App. Q, Paragraph 1
52.45................................... App. Q, Paragraph 3
52.46................................... N/A
52.47(a)................................ App. Q, Paragraph 4
52.47(b)................................ App. Q, Paragraph 5
52.47(c)................................ App. Q, Paragraph 6
52.49................................... App. Q, Paragraph 7
Subpart D--Standard Design Certification:
52.101.................................. 52.41
52.103.................................. 52.43
52.105.................................. 52.45
52.107.................................. 52.47
52.109.................................. 52.48
52.111.................................. 52.49
52.113.................................. 52.51
52.115.................................. 52.53
52.117.................................. 52.54
52.119.................................. 52.55
52.121.................................. 52.57
52.123.................................. 52.59
52.125.................................. 52.61
52.127.................................. 52.63
Subpart E--Standard Design Approvals:
52.131.................................. App. O, Introduction
52.133(a)............................... App. O, Paragraph 1
52.133(b)............................... App. O, Paragraph 2
52.135.................................. App. O, Paragraph 3
52.137.................................. App. O, Paragraph 4
52.139(a)............................... App. O, Paragraph 5
52.139(b)............................... None
52.141(a)............................... App
2.133(a)............................... App. O, Paragraph 1
52.133(b)............................... App. O, Paragraph 2
52.135.................................. App. O, Paragraph 3
52.137.................................. App. O, Paragraph 4
52.139(a)............................... App. O, Paragraph 5
52.139(b)............................... None
52.141(a)............................... App. O, Paragraph 5
52.141(b)............................... App. O, Paragraph 6
52.143.................................. App. O, Paragraph 7
Subpart G--Combined Licenses:
52.201.................................. 52.71
52.203.................................. 52.73
52.205.................................. 52.75
52.207.................................. 52.77
52.209.................................. 52.78
52.211.................................. 52.79
52.213.................................. 52.81
52.215.................................. 52.83
52.217.................................. 52.85
52.219.................................. 52.87
52.221.................................. 52.89
52.223.................................. 52.91
52.225.................................. 52.93
52.227.................................. 52.97
52.229.................................. 52.99
52.231.................................. 52.103
Subpart H--Manufacturing Licenses:
52.241.................................. App. M, Introduction
....... 52.87
52.221.................................. 52.89
52.223.................................. 52.91
52.225.................................. 52.93
52.227.................................. 52.97
52.229.................................. 52.99
52.231.................................. 52.103
Subpart H--Manufacturing Licenses:
52.241.................................. App. M, Introduction

52.243(a)............................... N/A
52.243(b)............................... App. M, Paragraph 7
52.243(c)............................... App. M, Paragraph 9
52.243(d)............................... App. M, Paragraph 10
52.243(e)............................... App. M, Paragraph 11
52.243(f)............................... App. M, Paragraph 8
52.245(a)............................... App. M, Paragraph 2
52.245(b)............................... App. M, Paragraph 3
52.245(c)............................... App. M, Paragraph 4(b)
52.247.................................. App. M, Paragraph 1
52.249.................................. App. M, Paragraph 4(a)
52.251.................................. N/A
52.253 (a) & (b)........................ App. M, Paragraph 5
52.253(c)............................... App. M, Paragraph 6
52.255.................................. N/A
52.257.................................. App. M, Paragraph 12
Subpart I--Duplicate Design Licenses:
52.261.................................. App. N, Introduction
52.263.................................. App. N, Paragraph 1
52.265.................................. App. N, Paragraph 2
52.265(c)............................... App. N, Paragraph 3
Subpart M--Enforcement:
52.401.................................. 52.111
52.403.................................. 52.113
------------------------------------------------------------------------

III. Discussion of Substantive Changes
..................... App. N, Paragraph 1
52.265.................................. App. N, Paragraph 2
52.265(c)............................... App. N, Paragraph 3
Subpart M--Enforcement:
52.401.................................. 52.111
52.403.................................. 52.113
------------------------------------------------------------------------

III. Discussion of Substantive Changes

A section-by-section analysis that explains the purpose and meaning
of all sections in 10 CFR part 52 will be provided in the supplementary
information for the final rule. The proposed rule makes the following
substantive changes:

A. 10 CFR Part 52, Early Site Permits, Standard Design Certifications,
and Combined Licenses for Nuclear Power Plants

General Provisions
The proposed rule would amend Sec. 52.3 to add definitions for
``modular design'' and ``prototype plant'' to the current 10 CFR part
52. 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 Sec. 52.103(g) (proposed Sec.
52.231(g)). This special provision for modular designs was added to 10
CFR 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 3 or 4
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. In a letter dated November 13, 2001 (comment A), NEI stated
that ``Part 1 of the definition would need to be revised for this
purpose so that it does not describe typical multi-unit sites
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. In a letter dated November 13, 2001 (comment A), NEI stated
that ``Part 1 of the definition would need to be revised for this
purpose so that it does not describe typical multi-unit sites. The NRC
staff should reconsider the need to define this term at all.'' The
Commission disagrees with NEI's recommendation because the term
``modular design'' needs to be defined to aid future use of the current
Sec. 52.103(g) (proposed Sec. 52.231(g)) by distinguishing the
intended definition from other definitions for ``modular design.''
Currently licensed multi-unit sites would not be affected by the
proposed Sec. 52.231(g). However, future applicants for a combined
license for a multi-unit site similar in concept to current multi-unit
sites (where each unit is similar in design but independent of all
other units) could also use this provision.
A definition for prototype plant is added to explain the type of
nuclear reactor that the Commission intended in the current Sec.
52.47(b) (proposed Sec. 52.107(b)) and intends in the proposed Sec.
52.211(b)(3). A prototype plant is a licensed nuclear reactor test
facility that is similar to and representative of either the first-of-
a-kind or certified 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 design features for the
first-of-a-kind or certified, advanced nuclear plant design, as well as
being used as a commercial nuclear power facility.
The proposed rule would remove Sec. Sec. 52.5 and 52.9 and replace
them with a new Sec. 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
testing of new or innovative design features for the
first-of-a-kind or certified, advanced nuclear plant design, as well as
being used as a commercial nuclear power facility.
The proposed rule would remove Sec. Sec. 52.5 and 52.9 and replace
them with a new Sec. 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. The purpose of this amendment is to clarify that these 10
CFR part 50 provisions are applicable to the licensing processes that
were formerly in 10 CFR part 50 (Appendices M, N, O, and Q) and are now
in 10 CFR part 52, as well as to the new licensing processes for early
site permits, standard design certifications, and combined licenses.
Although these provisions in 10 CFR part 50 may not refer to the
additional licensing processes in 10 CFR part 52, the new Sec. 52.5
makes it clear that a holder of or applicant for an approval,
certification, permit, site report, or license issued under 10 CFR part
52 must comply with all requirements in these provisions that are
otherwise applicable to applicants or licensees under 10 CFR part 50.
In a letter dated November 13, 2001 (comment G), NEI 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.
(comment G), NEI 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.

The Commission disagrees with the industry's proposal to create over 35
new general provisions that are tailored for 10 CFR part 52 because it
would appear to be an inefficient and burdensome addition. Therefore,
the Commission is proposing a new Sec. 52.5 that would make the
existing general provisions in 10 CFR part 50 applicable to the
licensing processes in 10 CFR part 52.
Early Site Permits
The proposed rule would amend Sec. 52.13 to state that an early
site permit can also be referenced in an application for a combined
license or a duplicate design license.
The proposed rule would amend Sec. 52.17(a)(1) to state that the
early site permit application should specify the range of facilities
that the applicant is requesting the site to be qualified for (e.g.
one, two, or three pressurized-water reactors). This new language is
consistent with the language in Paragraph 2 of current Appendix Q. The
Commission assumes that an applicant for an early site permit does not
know what type of nuclear plant it will build at the site. Therefore,
the application must specify the postulated design parameters for the
range of reactor types, the numbers of reactors, etc., to increase the
likelihood that the site will be qualified for the actual plant or
plants that the applicant decides to build. In a letter dated November
13, 2001 (comment 27), 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-viii), industry recommends a new Sec
hood that the site will be qualified for the actual plant or
plants that the applicant decides to build. In a letter dated November
13, 2001 (comment 27), 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-viii), industry recommends a new Sec. 52.17a.2.''
The Commission 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 Commission expects that
applicants for an early site permit will not have decided on a
particular type of nuclear power plant and Sec. 52.17(a)(1) was
revised to address this situation.
The Commission proposes to amend Sec. 52.17(a)(2) to clarify that
an ESP applicant has the flexibility of either addressing the matter of
alternative energy sources in the environmental

report supporting its ESP application, or deferring the consideration
of alternative energy sources to the time that the ESP is referenced in
a licensing proceeding. The Commission believes the current regulations
already afford the ESP applicant such flexibility, inasmuch as Sec.
52.17(a)(2) states that the environmental report submitted in support
of an ESP 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
constitutes part of the discussion of reasonable alternatives to the
proposed action, which is required by Sec. 102(2)(C)(iii) of NEPA
peration 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
constitutes part of the discussion of reasonable alternatives to the
proposed action, which is required by Sec. 102(2)(C)(iii) of NEPA. See
10 CFR 51.71(e) n.4; 46 FR 39440 (August 3, 1981) (proposed rule
eliminating consideration of need for power and alternative energy
sources at operating license stage), at 39441 (first column).
Accordingly, it is the Commission's view that Sec. 52.17(a)(2) already
provides the ESP applicant the flexibility of choosing to defer
consideration of alternative energy sources to the time (if ever) that
the ESP is referenced in a combined license or a construction permit
application. The proposed rule clarifies that the ESP applicant may
either include a discussion of alternative energy sources in its
environmental report, or defer consideration of the matter. The
Commission proposes to make a conforming amendment to Sec. Sec. 52.18
and 52.21 to make clear that the NRC's EIS need not address need for
power, or alternative energy sources (and therefore such matters may
not be litigated) if the ESP applicant chooses not to address either or
both of these matters in its environmental report. The Commission notes
that both the environmental report and EIS for an ESP must address the
benefits associated with issuance of the ESP (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
parameters, 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)
d with issuance of the ESP (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
parameters, 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 ESP must always be addressed in the
environmental report and EIS for an ESP, regardless of whether the ESP
applicant chooses to defer, pursuant to Sec. 52.17(a)(2),
consideration of the benefits associated with the construction and
operation of a nuclear power plant that may be located at the ESP site.
This is because the ``benefits * * * of the proposed action'' for which
the discussion may be deferred under Sec. Sec. 52.17(a)(2) are the
benefits associated with the construction and operation of a nuclear
power plant that may be located at the ESP site; the benefits which may
be deferred under Sec. 52.17(a)(2) are entirely separate from the
benefits of issuing an ESP. To put it another way, the proposed action
of issuing an ESP 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
Sec. 52.17(a)(2)\1\. With this clarification, the Commission does not
believe that further changes to the language of Sec. Sec. 52.17 and
52.18 are necessary.
---------------------------------------------------------------------------
he ``proposed action'' of
constructing and operating a nuclear power plant for which the
discussion of benefits (including need for power) may be deferred under
Sec. 52.17(a)(2)\1\. With this clarification, the Commission does not
believe that further changes to the language of Sec. Sec. 52.17 and
52.18 are necessary.
---------------------------------------------------------------------------

\1\ The Commission emphasizes that under Sec. 52.17(a)(2), only
the discussion of benefits (including need for power) of
constructing and operating a nuclear power reactor (or reactors),
and the discussion of alternative energy sources, may be deferred.
The ER must always address the ``environmental impacts of
construction and operation of a reactor, or reactors, which have
characteristics which fall within the postulated site parameters.''
---------------------------------------------------------------------------

The proposed rule would amend Sec. Sec. 52.24 and 52.39 to
clarify: (1) The information that the NRC must include in the early
site permit when it is issued; (2) the matters accorded finality in any
subsequent NRC review and proceeding for an application referencing the
early site permit; and (3) the matters that may be challenged in a
contention to be resolved in an adjudication, versus those matters that
may be raised in a petition to be processed in accord with 10 CFR
2.206. Section 52.21 would be amended to clarify that an application
referencing an early site permit must, in addition to showing that the
design of the facility falls within the site parameters specified in
the early site permit, demonstrate that all terms and conditions of the
early site permit have been satisfied. Section 52.24 would also be
amended to provide that the early site permit must state the site
parameters, as well as the ``terms and conditions,'' of the early site
permit, rather than the ``conditions and limitations'' as is currently
provided. No substantive change in Sec
ified in
the early site permit, demonstrate that all terms and conditions of the
early site permit have been satisfied. Section 52.24 would also be
amended to provide that the early site permit must state the site
parameters, as well as the ``terms and conditions,'' of the early site
permit, rather than the ``conditions and limitations'' as is currently
provided. No substantive change in Sec. 52.24 is intended by the
proposed amendment; the change is proposed to provide consistency with
Sec. 52.39(a)(2) and paragraph (a)(2)(iii) of the current rule, which
also refer to ``site parameters'' and ``terms and conditions.''
The proposed rule would add Sec. 52.28 to state that transfer of
an early site permit from its existing holder to a new applicant will
be processed under 10 CFR 50.80, which contains provisions for transfer
of licenses. In a letter dated November 13, 2001 (comment 19), NEI
recommended that a new section be added to part 52 to clarify the
process for transfer of an early site permit. The Commission 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 Commission believes that the
procedures and criteria for transfer of utilization facility licenses
in 10 CFR 50.80 (and the procedures in subpart M of 10 CFR part 2 for
the conduct of any hearing) should apply to the transfer of an early
site permit.
Section 52.39(a) would be amended to uniformly refer to ``terms or
conditions'' of an early site permit. Section 52.39(a)(1) would also be
amended to remove the term, ``requirements,'' and clarify that the
Commission may not change or impose new site characteristics, terms, or
conditions on the early site permit, including emergency planning
requirements, unless the special backfitting criteria in Sec.
52.39(a)(1) are satisfied
uniformly refer to ``terms or
conditions'' of an early site permit. Section 52.39(a)(1) would also be
amended to remove the term, ``requirements,'' and clarify that the
Commission may not change or impose new site characteristics, terms, or
conditions on the early site permit, including emergency planning
requirements, unless the special backfitting criteria in Sec.
52.39(a)(1) are satisfied. No substantive change is intended by this
clarification; the Commission believes that ``site characteristics,
terms, or conditions'' of an early site permit more accurately describe
the existing scope of matters subject to the special backfitting
criteria in Sec. 52.39(a)(1).
Early Site Reviews
The proposed rule would amend certain paragraphs of the current
Appendix Q to 10 CFR part 52 (proposed Sec. Sec. 52.41, 52.43, and
52.47) to clarify that an early site review can also be used in an
application for a combined license or a duplicate design license.
Standard Design Certifications
The proposed rule would amend the current Sec. Sec. 52.41 and
52.45 (proposed Sec. 52.101 and Sec. 52.105) to clarify that a
certified design may be referenced in an application for a duplicate
design license, as well as a combined license application, filed under
part 52.
The proposed rule would remove the requirements currently located
in Sec. Sec. 52.43(c), 52.45(c), and 52.47(b)(2)(ii) because the
Commission has decided not to require a final design approval (FDA) as
a prerequisite for certification
fy that a
certified design may be referenced in an application for a duplicate
design license, as well as a combined license application, filed under
part 52.
The proposed rule would remove the requirements currently located
in Sec. Sec. 52.43(c), 52.45(c), and 52.47(b)(2)(ii) because the
Commission has decided not to require a final design approval (FDA) as
a prerequisite for certification

of a standard plant design under the new subpart D of 10 CFR part 52.
This requirement was included in 10 CFR part 52 because, at the time of
the original rulemaking, the NRC had no experience with design
certification applications. By requiring an FDA as a prerequisite for
certification, the NRC indicated that the licensing processes for
design certifications and FDAs were similar, even though the
requirements for and finality of design certifications differ from that
of FDAs. The NRC has considerable experience with design certification
applications and the requirement to apply for an FDA as part of an
application for design certification is no longer needed.
In a letter dated April 3, 2001 (comment 2), NEI commented
``Industry prefers to retain modified provisions. We agree that an FDA
should be an option but not a prerequisite. Also, deletion recommended
for 52.47(b)(2)(ii).'' The Commission has decided not to retain these
provisions. The proposed processes in subparts D and E allow future
applicants for design certification the option to apply for an FDA for
the same design information.
The proposed rule would also amend the current Sec. 52.45(d)
(proposed Sec. 52.105(c)) to correct the reference to the filing
requirements in Sec. 50.30(a) and delete the reference to Sec. 50.4.
The applicability of the requirements in Sec. 50.4 is set forth in the
new Sec. 52.5. No substantive change in the filing requirements is
intended by this correction.
The proposed rule would amend the current Sec. 52.47 (proposed
Sec
the current Sec. 52.45(d)
(proposed Sec. 52.105(c)) to correct the reference to the filing
requirements in Sec. 50.30(a) and delete the reference to Sec. 50.4.
The applicability of the requirements in Sec. 50.4 is set forth in the
new Sec. 52.5. No substantive change in the filing requirements is
intended by this correction.
The proposed rule would amend the current Sec. 52.47 (proposed
Sec. 52.107) to conform the statement of the requirements for
acceptable inspections, tests, analyses, and acceptance criteria
(ITAAC) in Sec. 52.107 with the Atomic Energy Act (AEA) and the
requirements in the current Sec. 52.97(b) [proposed Sec. 52.227(b)].
This clarification of the previous regulatory text, which condensed the
language in Sec. 52.79(c) and Sec. 52.97(b), is intended to avoid any
future misunderstandings.
Design Certification Backfit Requirement
The proposed rule would amend the special backfit requirement in
the current Sec. 52.63(a)(1) (proposed Sec. 52.127(a)(1)) to provide
the Commission with the ability to make changes to the design
certification rules or the certification information in the generic
design control documents that reduce unnecessary regulatory burdens.
Section 52.63(a)(1) currently states 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
r the certification information in the generic
design control documents that reduce unnecessary regulatory burdens.
Section 52.63(a)(1) currently states 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. The regulation does not appear,
on its face, to permit changes to the certification 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 may not be able to
be made under the current Sec. 52.63(a)(1) is a proposed change to the
three design certification rules in Appendices A, B and C of 10 CFR
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, in order to reduce unnecessary regulatory burden (64 FR
53582, October 4, 1999).
To allow the Commission to modify the design certification rules in
10 CFR part 52 to incorporate the revised Sec. 50.59 change criteria,
and to allow the Commission to make future changes to reduce
unnecessary regulatory burden, the Commission is proposing to amend
Sec. 52.127(a)(1) to include a new provision that explicitly allows
the Commission to change the design certification rules or
certification information if the change provides a reduction in
regulatory burden and maintains protection to public health and safety
and common defense and security
to make future changes to reduce
unnecessary regulatory burden, the Commission is proposing to amend
Sec. 52.127(a)(1) to include a new provision that explicitly allows
the Commission to change the design certification rules or
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, e.g., 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 Regulatory Guide 1.174). Changes to the
design certification rules must be accomplished through rulemaking,
with opportunity for public comment. Once a design certification rule
is changed through rulemaking, under proposed Sec. 52.127(a)(2) the
provisions would apply to all future applications referencing the
design certification rule as well as all current plans referencing the
design certification, unless the change has been rendered ``technically
irrelevant'' through other action taken under paragraphs (a)(3) or
(b)(1) of Sec. 52.127. Thus, standardization is maintained by ensuring
that any changes to a design certification rule intended to reduce
regulatory burden are imposed upon all nuclear power plants referencing
the design certification rule.
In a letter dated November 13, 2001, NEI stated:
hange has been rendered ``technically
irrelevant'' through other action taken under paragraphs (a)(3) or
(b)(1) of Sec. 52.127. Thus, standardization is maintained by ensuring
that any changes to a design certification rule intended to reduce
regulatory burden are imposed upon all nuclear power plants referencing
the design certification rule.
In a letter dated November 13, 2001, NEI stated:

Furthermore, we do not think it is necessary to modify 10 CFR
52.63(a)(1) in order to make conforming, administrative or similar
changes to the DCRs, such as those needed to conform the DCRs to the
revised 10 CFR 50.59. Nor do we think the Commission intended the
DCR backfit provisions to inhibit these types of changes. Rather, we
believe 10 CFR 52.63(a)(1) is intended to apply to changes in the
standard design approved via the DCR. We recommend the Commission
clarify this intent and provide guidance to the NRC staff allowing
certain changes to the DCRs (such as those needed to conform to the
revised 10 CFR 50.59) within the existing DCR backfit provisions.

The Commission received similar comments from General Electric Company,
Entergy, and Exelon in November 2001. The Commission disagrees with
these comments and has concluded that it is necessary to amend Sec.
52.63(a)(1) to allow changes to the design certification rules that
reduce unnecessary regulatory burden, or do not constitute a backfit.
The current Sec. 52.63(a)(1) (proposed Sec. 52.127(a)(1)) was
also modified to replace ``a modification'' with ``the change,'' in
order to clarify that the three criteria for changes apply to
modifications, rescissions or imposition of new requirements. Also, the
Commission is clarifying the proposed Sec
ication rules that
reduce unnecessary regulatory burden, or do not constitute a backfit.
The current Sec. 52.63(a)(1) (proposed Sec. 52.127(a)(1)) was
also modified to replace ``a modification'' with ``the change,'' in
order to clarify that the three criteria for changes apply to
modifications, rescissions or imposition of new requirements. Also, the
Commission is clarifying the proposed Sec. 52.127 to be consistent
with its original intent (refer to 54 FR 15372; April 18, 1989) that
the special backfit requirements apply to the certification information
in the generic design control documents, not to the provisions in the
design certification rules, e.g., Section VI.E of Appendix A to 10 CFR
part 52. Any proposed changes to these provisions that set forth how
the design certification rules are to be used are controlled by the
normal backfit requirements in 10 CFR 50.109.
The proposed rule would amend the current Sec. 52.63(a)(2)
(proposed Sec. 52.127(a)(2)) to delete the reference to Sec.
52.63(a)(4) (proposed Sec. 52.127(a)(4)). The reference to Sec.
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 Sec. 52.63(a)(2) deals with modifications
that the NRC may impose on a design certification rule under Sec.
52.63(a)(3) or Sec. 52.63(b)(1)

(proposed Sec. 52.127(a)(3) or Sec. 52.127(b)(1)). No substantive
change is intended by the amendment which merely clarifies the original
intent of the rule.
Standard Design Approvals
The proposed rule would amend the current Section 3 of Appendix O
to 10 CFR part 52 (proposed Sec. 52.135) to clarify that applications
for standard design approvals should contain all of the applicable
technical information required by Sec. 50.34
2.127(b)(1)). No substantive
change is intended by the amendment which merely clarifies the original
intent of the rule.
Standard Design Approvals
The proposed rule would amend the current Section 3 of Appendix O
to 10 CFR part 52 (proposed Sec. 52.135) to clarify that applications
for standard design approvals should contain all of the applicable
technical information required by Sec. 50.34. The amendment would also
require applications for standard design approvals to provide the same
technical information required for applications for standard design
certifications (e.g., demonstration of compliance with any technically
relevant Three Mile Island requirements, proposed technical resolutions
of unresolved safety issues and medium- and high-priority generic
safety issues, and a design-specific probabilistic risk assessment
(PRA)). This clarification is consistent with past practice regarding
applications for future designs and would implement the Commission's
Policy Statements on Severe Reactor Accidents (50 FR 32138, August 8,
1985) and Nuclear Power Plant Standardization (52 FR 34884, September
15, 1987). This amendment would not require applicants to provide
proposed ITAAC because standard design approvals are referenced in
applications for construction permits and operating licenses under 10
CFR part 50, and the verification process used for 10 CFR Part 50
applications does not use ITAAC.
The proposed rule would amend the current Appendix O to 10 CFR Part
52 (proposed Sec. 52.139) to specify that the duration of a standard
design approval is for 15 years. In a letter dated November 13, 2001
(comment 18.a), NEI commented:

Industry recommends FDAs be valid for 15 years. This is
consistent with Commission direction in COMSECY-94-025 to update the
lead plant FDA to provide a 15 year duration instead of the five
years initially provided. The ABWR and System 80+ FDAs were so
revised in 1994; the designs were certified in 1997.
val is for 15 years. In a letter dated November 13, 2001
(comment 18.a), NEI commented:

Industry recommends FDAs be valid for 15 years. This is
consistent with Commission direction in COMSECY-94-025 to update the
lead plant FDA to provide a 15 year duration instead of the five
years initially provided. The ABWR and System 80+ FDAs were so
revised in 1994; the designs were certified in 1997.

The Commission agrees with industry's recommendation. The final design
approvals (FDAs) for the three certified designs were originally issued
for a five year duration, in accordance with the Commission's Policy
Statement on Standardization of Nuclear Power Plants (43 FR 38954,
August 31, 1978). Only after design certifications were issued for the
ABWR and the System 80+ designs did the Commission direct, for
consistency, that the FDAs be revised to provide the same term as for
the design certification. These actions did not change the Commission's
policy for FDAs issued by themselves. The Commission has now decided
that the duration of standard design approvals should correspond to the
duration of design certifications. The Commission has not identified
any compelling technical or policy considerations that would lead the
Commission to maintain a shorter effective time period for an FDA as
compared to a design certification.
Combined Licenses
The proposed rule would amend the current Sec. 52.73 (proposed
Sec. 52.203(a)) to clarify that a site report issued under proposed
subpart B of 10 CFR part 52 may also be referenced in an application
for a combined license application filed under 10 CFR part 52. This
amendment would also add the requirements in the current Sec. 52.63(c)
(proposed Sec. 52.127(c)) to the new Sec. 52.203(b) to clarify that
this requirement applies to applicants for a combined license
3(a)) to clarify that a site report issued under proposed
subpart B of 10 CFR part 52 may also be referenced in an application
for a combined license application filed under 10 CFR part 52. This
amendment would also add the requirements in the current Sec. 52.63(c)
(proposed Sec. 52.127(c)) to the new Sec. 52.203(b) to clarify that
this requirement applies to applicants for a combined license. This
provision requires that, prior to 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
such information is necessary for the Commission 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 Sec. 52.63(c) be deleted and the
remaining provision be added to the current Sec. 52.79 rather than the
current Sec. 52.73. The Commission agrees with NEI that 10 CFR part 52
should be modified to clarify that the requirement in current Sec.
52.63(c) applies to applicants for a combined license, and that the
last sentence be deleted. However, the Commission is adding the
remaining provision to what was Sec. 52.73(b) (proposed Sec.
52.203(b)) and not to Sec. 52.79 (proposed Sec. 52.211) as
recommended by NEI.
The proposed rule would amend the current Sec. 52.78 (proposed
Sec. 52.209) to clarify the requirements applicable to an applicant
for, and holder of, a combined license with respect to the training
program required by 10 CFR 50.120. As currently written, Sec. 52.78
simply indicates that the application must demonstrate compliance with
the training program requirements in Sec. 50.120
by NEI.
The proposed rule would amend the current Sec. 52.78 (proposed
Sec. 52.209) to clarify the requirements applicable to an applicant
for, and holder of, a combined license with respect to the training
program required by 10 CFR 50.120. As currently written, Sec. 52.78
simply indicates that the application must demonstrate compliance with
the training program requirements in Sec. 50.120. There is no explicit
requirement with respect to the applicant/licensee to implement the
training program. Furthermore, proposed Sec. 52.215(b) indicates that,
after a combined license is issued but before the Commission has
authorized operation under Sec. 52.231, the combined license holder
shall comply with all requirements in Title 10 of the Code of Federal
Regulations applicable to holders of construction permits for nuclear
power reactors. However, Sec. 50.120 refers to a ``nuclear power plant
applicant;'' therefore, Sec. 50.120 would not apply to a combined
license holder even under the language of proposed Sec. 52.215(b).
To remove any ambiguity in this matter, the Commission is proposing
to revise in its entirety the language in current Sec. 52.78, which is
being re-designated as Sec. 52.209. The proposed rule provides that
the application must ``describe'' the training program required by
Sec. 50.120. In addition, the proposed rule states that the training
program described in the application must be ``established,
implemented, and maintained'' no later than eighteen (18) months prior
to the scheduled date for initial loading of fuel, as provided for in
Sec. 52.231(a). By ``established [and] implemented'', the Commission
intends to distinguish between the requirement to merely ``describe''
the training program in the application, versus the requirement for the
combined license holder to establish (e.g., establish a training
organization, fill staff positions, write procedures, etc.) and
implement (i.e., perform training of applicable operating plant
personnel in accordance with Sec
lemented'', the Commission
intends to distinguish between the requirement to merely ``describe''
the training program in the application, versus the requirement for the
combined license holder to establish (e.g., establish a training
organization, fill staff positions, write procedures, etc.) and
implement (i.e., perform training of applicable operating plant
personnel in accordance with Sec. 50.120) the training program. The
proposed rule also clarifies that the eighteen (18) month period by
which the training program must be established and implemented is
measured from the combined licensee's scheduled date for fuel load
under proposed Sec. 52.231(a) (current Sec. 52.103(a)).
Referencing an Early Site Permit
The proposed rule would amend current Sec. Sec. 52.39 and 52.79
(proposed Sec. 52.211) to require a license applicant referencing an
early site permit to update and correct the emergency preparedness
information provided under Sec. 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 and any emergency plans that were
approved as part of the early site permit in accordance with Sec.
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 may be deferred until a ``lessons learned'' rulemaking updating
10 CFR part 52 is conducted after the first design certification
rulemakings are issued
and any emergency plans that were
approved as part of the early site permit in accordance with Sec.
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 may be deferred until a ``lessons learned'' rulemaking updating
10 CFR part 52 is conducted after the first design certification
rulemakings are 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, the Nuclear Energy Institute (NEI)
submitted a letter dated September 8, 1998 (comment 2.d), expressing
NEI's opposition to a requirement for updating emergency preparedness
information throughout 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. Thereafter, 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 Commission agrees with the Illinois Department of Nuclear
Safety that the emergency preparedness information approved when the
early site permit was issued must be updated if there is new
information which may materially affect the Commission's earlier
determination on emergency preparedness, or if the new information is
needed to correct inaccuracies in the emergency preparedness
information approved in the early site permit
Department of Nuclear
Safety that the emergency preparedness information approved when the
early site permit was issued must be updated if there is new
information which may materially affect the Commission's earlier
determination on emergency preparedness, or if the new information is
needed to correct inaccuracies in the emergency preparedness
information approved in the early site permit. In the absence of such
an updating requirement, the NRC would bear the responsibility of
identifying whether there is new information on emergency preparedness
that necessitates a re-examination of the Commission's earlier
emergency preparedness determinations for the early site permit, and
the early site permit holder or applicant referencing the early site
permit would be under no obligation to correct inaccurate emergency
preparedness information in the early site permit or approved emergency
plan. However, the Commission also 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 decided that Sec. 52.39 and current
Sec. 52.79 (proposed Sec. 52.211) should contain an updating
requirement to be imposed upon the applicant referencing an early site
permit.
The proposed rule redesignates paragraph (b) of current Sec. 52.39
as paragraph (c), and adds a new paragraph (b) requiring an applicant
for a construction permit, operating license, duplicate design license,
or combined license whose application references an early site permit
to update and correct the emergency preparedness information provided
under Sec. 52.17(b), and to discuss whether the new information may
materially change the bases for compliance with the applicable NRC
requirements. A parallel requirement is included in proposed Sec
on permit, operating license, duplicate design license,
or combined license whose application references an early site permit
to update and correct the emergency preparedness information provided
under Sec. 52.17(b), and to discuss whether the new information may
materially change the bases for compliance with the applicable NRC
requirements. A parallel requirement is included in proposed Sec.
52.211(d)(1) to ensure that applicants for combined licenses
referencing an early site permit will submit the updated emergency
preparedness information. 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 Sec. 52.39(a)(1). New information which materially
changes the Commission's determination of the matters in Sec.
52.17(b), or results in modifications of existing terms and conditions
under Sec. 52.39(a)(1) would be subject to litigation during the
construction permit, operating license, duplicate design license, or
combined license proceedings in accordance with Sec. 52.39(a)(2)(ii).
Not all new information on emergency preparedness would be subject
to challenge in a hearing under Sec. 52.39(a)(2)(ii). For example, an
emergency plan may have to be updated to reflect current telephone
numbers, the 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 the current name of a hospital
facility. Such corrections do not materially change the NRC's
previously-stated bases for accepting the early site permit emergency
plan; therefore, a hearing contention would not be admitted under Sec
e 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 the current name of a hospital
facility. Such corrections do not materially change the NRC's
previously-stated bases for accepting the early site permit emergency
plan; therefore, a hearing contention would not be admitted under Sec.
52.39(a)(2)(ii) (or any other provision of Sec. 52.39) in a proceeding
for a license referencing the early site permit. By 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. Thus, such information may be the
basis for a change in the early site permit's terms and conditions
related to emergency preparedness under Sec. 52.39(a)(1), as well as
the basis for a hearing contention under Sec. 52.39(a)(2)(ii)--
assuming that the requirements in 10 CFR part 2 for admission of a
contention are met.
An updating requirement for early site permit information other
than emergency preparedness information does not appear to be
necessary, inasmuch as it is unlikely that there would be changes to
the information previously submitted on the site, such that a
significant change to the site characteristics, terms, and conditions
would be necessary if requested under the provisions of Sec.
52.39(a)(2). If the site does not conform to the characteristics of the
early site permit, an interested person may submit a petition under
Sec. 52.39(a)(2)(ii) alleging that the site does not conform to the
early site permit. Accordingly, the proposed rule does not include an
updating requirement for other early site permit information.
The proposed rule would amend Sec
e provisions of Sec.
52.39(a)(2). If the site does not conform to the characteristics of the
early site permit, an interested person may submit a petition under
Sec. 52.39(a)(2)(ii) alleging that the site does not conform to the
early site permit. Accordingly, the proposed rule does not include an
updating requirement for other early site permit information.
The proposed rule would amend Sec. 52.79(a)(1) (proposed Sec.
52.211(a)(1)), which currently requires a combined license application
referencing an early site permit to contain information demonstrating
that the design of the facility falls within the parameters specified
in the early site permit, and information needed to resolve any other
significant environmental issue not considered in the proceeding on the
referenced early site permit. Currently, Sec. 52.79(a)(1) requires a
combined license application referencing an early site permit to
contain information demonstrating that the design of the facility falls
within the site parameters specified in the early site permit. However,
Sec. 52.79(a) does not explicitly require the application to address
whether the terms and conditions specified in the early site permit
under

Sec. 52.24 have been 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, the Commission is
proposing to include a proposed Sec. 52.211(a)(1)(iii) by requiring
the application to address whether the terms and conditions specified
in the early site permit under Sec. 52.24 have been met (the
Commission also proposes to rearrange paragraph (a)(1) by dividing the
criteria to be met by an application referencing an early site permit
into separate subdivisions (i), (ii), and (iii)). The Commission's
intent, as reflected in the words, ``have been met,'' is that all terms
and conditions will be met prior to issuance of the combined license
ite permit under Sec. 52.24 have been met (the
Commission also proposes to rearrange paragraph (a)(1) by dividing the
criteria to be met by an application referencing an early site permit
into separate subdivisions (i), (ii), and (iii)). The Commission's
intent, as reflected in the words, ``have been met,'' is that all terms
and conditions will be met prior to issuance of the combined license.
Testing Requirements for Advanced Reactors
The proposed rule would amend the current Sec. 52.79(b) (proposed
Sec. 52.211(b)) to revise the requirements for combined license
applications that do not reference a design certification rule by
adding the current Sec. 52.47(b)(2) (proposed Sec. 52.107(b)(2)) to
the list of requirements in the proposed Sec. 52.211(b)(1) that a
combined license applicant must comply with. This amendment will
provide consistency between the current advanced reactor testing
requirements in subpart B of part 52 (Sec. 52.47(b)(2)) and the
proposed testing requirements in the proposed subpart G of part 52
(Sec. 52.211(b)). This amendment will require a combined license
applicant that references a custom advanced reactor design to also
perform the design qualification testing required by the current Sec.
52.47(b)(2) for design certification applicants. If a combined license
application references a certified advanced reactor design, the
qualification testing required by Sec. 52.47(b)(2) will have been
performed. The amendment also requires (proposed Sec. 52.211(b)(3))
that if a licensed prototype plant (see definition in proposed Sec.
52.3) is used to meet the qualification testing requirements in the
current Sec. 52.47(b)(2), additional requirements on siting, safety
features, or operational conditions may be required for licensing, in
order to compensate for uncertainties associated with the performance
of new or innovative safety features in the prototype plant.
The codification of testing requirements in the current Sec
2.3) is used to meet the qualification testing requirements in the
current Sec. 52.47(b)(2), additional requirements on siting, safety
features, or operational conditions may be required for licensing, in
order to compensate for uncertainties associated with the performance
of new or innovative safety features in the prototype plant.
The codification of testing requirements in the current Sec.
52.47(b)(2) was a principal issue in the development of 10 CFR part 52
(see Section II of 54 FR 15372; April 18, 1989). The testing
requirements in Sec. 52.47(b)(2), to demonstrate the performance of
safety features for nuclear power plants that differ significantly from
evolutionary light-water reactors or utilize 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 safety features will perform as predicted in the applicant's
safety analysis report, that the effects of systems interactions are
acceptable, and to provide sufficient data to validate analytical
codes. 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-of-performance
testing for all advanced reactors (see 51 FR 24643; July 8, 1986) and
the Commission's goal of resolving all design issues before authorizing
construction.
During the development of 10 CFR part 52, the focus of the nuclear
industry and the NRC staff was on applications for design
certification. That is why the testing requirements to qualify new or
innovative safety features was only included in subpart B of 10 CFR
part 52, ``Standard Design Certifications.'' The tests to qualify a
design feature are different than verification tests, which are
required by Sec
opment of 10 CFR part 52, the focus of the nuclear
industry and the NRC staff was on applications for design
certification. That is why the testing requirements to qualify new or
innovative safety features was only included in subpart B of 10 CFR
part 52, ``Standard Design Certifications.'' The tests to qualify a
design feature are different than verification tests, which are
required by Sec. 52.79(c) and performed in accordance with section XI,
``Test Control,'' of Appendix B to 10 CFR part 50. Verification tests
are used to provide assurance that construction and installation of
equipment (as-built) in the facility has been accomplished in
accordance with the approved design.
Exelon Generation and NEI commented on the addition of testing
requirements for combined license applications, in letters dated
November 13, 2001. NEI stated:

COL application requirements in Sec. 52.79(b)(1) have been
modified to include a reference to the design certification
application requirements of Sec. 52.47(b)(2)(i). Under this
proposal, an applicant seeking a COL for a non-certified design that
differs significantly from typical light water reactors would have
to demonstrate safety feature performance through either (A)
analysis, testing, or experience, or (B) full-scale prototype
testing. This requirement is entirely appropriate for design
certification applicants. However, as discussed below, we believe it
is unnecessary to apply these requirements to COL applicants, and
that the potential requirement for full-scale prototype testing is
particularly inappropriate.
First, part 52 should not be modified to open the door to
requiring a COL applicant, who does not reference a certified
design, to build and complete testing of a full-scale prototype
before the granting of the license. The potential to require
prototype testing to support issuance of a COL is contrary to
Commission guidance in the part 52 Statements of Consideration
ticularly inappropriate.
First, part 52 should not be modified to open the door to
requiring a COL applicant, who does not reference a certified
design, to build and complete testing of a full-scale prototype
before the granting of the license. The potential to require
prototype testing to support issuance of a COL is contrary to
Commission guidance in the part 52 Statements of Consideration. The
Commission clearly recognized ``licensing the prototype for
commercial operation'' as a path open to applicants under subpart C
of part 52 that could lessen the burden of having to demonstrate
innovative designs through full scale prototype testing. We agree
with the further statement by the Commission that, ``[i]t is well to
remember also that, under the rule, prototype testing is required
only for certification or an unconditional design approval, if at
all.'' * * * In sum, through its existing requirements and
regulatory authority, the NRC is assured of (1) Adequate information
to support required COL reviews and safety determinations, and (2)
satisfactory demonstration of innovative design features during
startup and power ascension testing. The proposed new COL
application requirements are unnecessary and should not be carried
forward into the part 52 NOPR (Notice of Proposed Rulemaking).

The Commission disagrees with NEI and Exelon regarding the need to
perform qualification testing for new or innovative safety features in
all advanced reactor designs. The Commission reformed the licensing
process for new nuclear plants with the issuance of 10 CFR part 52 in
1989 and required applicants to demonstrate that safety features will
perform as predicted in their final safety analysis report. Although
the focus of the NRC staff in 1989 was on applications for design
certification, the Commission intended that testing to qualify design
features (proof-of-performance testing) would be required for all
advanced reactors, including custom designs (see Question 6 at 51 FR
24646; July 8, 1986)
nstrate that safety features will
perform as predicted in their final safety analysis report. Although
the focus of the NRC staff in 1989 was on applications for design
certification, the Commission intended that testing to qualify design
features (proof-of-performance testing) would be required for all
advanced reactors, including custom designs (see Question 6 at 51 FR
24646; July 8, 1986). Furthermore, it would make no sense for the
Commission to require testing for design certification (paper designs)
and not require testing for applications to build and operate an actual
advanced nuclear reactor.
Although the Commission has stated that it favors the use of
prototypical demonstration facilities and that prototype testing is
likely to be required for certification of advanced non-light-water
designs (see policy at 51 FR 24646; July 8, 1986 and Section II of 54
FR 15372 on 10 CFR part 52; April 18, 1989), the proposed rule does not
mandate the use of a prototype plant. Rather, the proposed rule
provides that if a prototype plant is used to qualify an advanced
reactor design, then additional requirements may be required for
licensing of the prototype to compensate for any uncertainties with the
unproven safety features. Also, the prototype plant could be used for

commercial operation. Therefore, the Commission proposes to amend Sec.
52.79(b) (proposed Sec. 52.211(b)) to implement its original intent in
adopting 10 CFR Part 52 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
reactors.
Probabilistic Risk Assessments
The proposed rule would also amend the current Sec. 52.79(b)
(proposed Sec. 52.211(b)) to adopt a requirement to submit a plant-
specific PRA as part of an application for a combined license. The
current Sec. 52.79(b) references Sec. 52.47(a)(1)(v), which requires
a design-specific PRA within a design certification application
for all advanced nuclear
reactors.
Probabilistic Risk Assessments
The proposed rule would also amend the current Sec. 52.79(b)
(proposed Sec. 52.211(b)) to adopt a requirement to submit a plant-
specific PRA as part of an application for a combined license. The
current Sec. 52.79(b) references Sec. 52.47(a)(1)(v), which requires
a design-specific PRA within a design certification application. This
amendment (Sec. 52.211(b)(2)) would require an application for a
combined license to contain a plant-specific PRA that covers all of the
nuclear plant design, including site-specific design features (e.g.,
the ultimate heat sink). If the combined license application referenced
a certified design, this amendment (Sec. 52.211(b)(5)) would require
the design-specific PRA to be updated to include site-specific design
features and to account for any design changes. In a letter dated April
3, 2001 (comment 11.1a), NEI stated ``we agree on the NRC vision for a
plant-specific PRA at COL that supplements the DC PRA with any changes
that affect the DC PRA plus site-specific (interface) design
information.''
The purpose of the requirement for a plant-specific PRA is to
identify and address potential design and operational vulnerabilities,
gain insights about the risk of the design, assess the balance between
preventive and mitigative features in the design, to determine
quantitatively whether the design represents a reduction in risk over
current operating plants, and to determine how the risk associated with
the new design relates to the Commission's safety goals. Accordingly,
the Commission proposes to amend Sec. 52.211(b) to require an
application for a combined license to contain a plant-specific PRA.
Resolution of ITAAC
The proposed rule would amend the current Sec. 52.79(c) (proposed
Sec. 52.211(c)), current Sec. 52.97(a) (proposed Sec. 52.227(a)),
current Sec. 52.99 (proposed Sec. 52.229(e)), and current Sec. Sec.
52.103(a) and (g) (proposed Sec. Sec
dingly,
the Commission proposes to amend Sec. 52.211(b) to require an
application for a combined license to contain a plant-specific PRA.
Resolution of ITAAC
The proposed rule would amend the current Sec. 52.79(c) (proposed
Sec. 52.211(c)), current Sec. 52.97(a) (proposed Sec. 52.227(a)),
current Sec. 52.99 (proposed Sec. 52.229(e)), and current Sec. Sec.
52.103(a) and (g) (proposed Sec. Sec. 52.231(a) and (g)) to provide an
applicant for a combined license with a process for resolving certain
acceptance criteria in one or more of the ITAAC required by the
proposed Sec. 52.211(c) before issuance of the combined license. In a
letter dated November 13, 2001 (comment 20), NEI recommended that
Subpart C be revised to allow for completion of design acceptance
criteria (DAC) at the COL application stage. NEI made this
recommendation 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. DAC were originally written to be verified as part of
the normal, post-combined license, ITAAC verification process.
The Commission agrees with NEI's recommendation that combined
license applicants be permitted to demonstrate DAC completion as part
of the combined license application, for several reasons. First,
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 Commission's original
intent
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 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. Finally, the Commission believes that completion of DAC
before issuance of the combined license will enhance public confidence
in the overall licensing process because the public will have an
opportunity to challenge whether the design has been properly completed
before construction begins. Accordingly, the Commission proposes that 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 new process would also
allow findings on successful completion of inspections or tests of
components procured before the issuance of the combined license.
The proposed rule would also amend the current Sec. 52.99
(proposed Sec. 52.229 (b), (c) and (d)) and the current Sec. 52.103
(proposed Sec. 52.231(h)) 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)
of
components procured before the issuance of the combined license.
The proposed rule would also amend the current Sec. 52.99
(proposed Sec. 52.229 (b), (c) and (d)) and the current Sec. 52.103
(proposed Sec. 52.231(h)) 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 rules. The purpose of the requirement in paragraph
(b) of proposed Sec. 52.229 is to make it clear 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 successfully completed. Paragraph (c) of
proposed Sec. 52.229 requires the licensee to notify the NRC that the
required inspections, tests, and analyses in the ITAAC have been
completed and that the acceptance criteria have been met. Paragraph (d)
simply 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. Finally, paragraph (h) of Sec. 52.231 states that ITAAC
do not, by virtue of their inclusion in the DCD, 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 current Sec
met. Finally, paragraph (h) of Sec. 52.231 states that ITAAC
do not, by virtue of their inclusion in the DCD, 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 current Sec. 52.97 and
Section VIII of the design certification rules have been complied with.
In a letter dated April 3, 2001 (comment 23), NEI stated ``consider
incorporating DCR general provisions into subpart C as appropriate.''
The Commission has decided to add these ITAAC requirements to proposed
Sec. 52.229 because it believes that these provisions embody general
principles that are applicable to all holders of combined licenses.
Commission Finding on Acceptance Criteria
The proposed rule would amend the current Sec. 52.83 (proposed
Sec. 52.215) and the current Sec. 52.99 (proposed Sec. 52.229(e)) to
clearly state the

Commission's determination that the NRC staff should be 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. Currently, Sec. 52.99
states that ``the Commission shall ensure that the required
inspections, tests, and analyses are performed and, prior to operation
of the facility, shall find that the prescribed acceptance criteria are
met.'' When part 52 was first adopted by the Commission in 1989 (54 FR
15372, April 18, 1989), Sec. 52.99 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 requirement for a Commission finding on
acceptance criteria was contained in Sec. 52.103(g). The Commission
adopted the current language of Sec
mmission in 1989 (54 FR
15372, April 18, 1989), Sec. 52.99 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 requirement for a Commission finding on
acceptance criteria was contained in Sec. 52.103(g). The Commission
adopted the current language of Sec. 52.99 in 1992 (57 FR 60975,
December 23, 1992) to reflect changes to Section 185 of the AEA made by
Congress in the Energy Policy Act of 1992 (1992 EPA), which states:

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 Sec. 52.99 adopted by the Commission in 1992
simply reflect 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 alter the Commission's determination that the NRC staff is
responsible for ensuring that ``the required inspections, tests and
analyses in the ITAAC are performed,'' and by doing so alter the
Commission's long-standing delegation of inspection and oversight
activities to the NRC staff. For these reasons, the Commission proposes
that Sec. 52.99 (proposed Sec. 52.229(e)) state that the NRC staff
shall be responsible for ensuring that inspections, tests and analyses
in the ITAAC have been performed. The requirement for a Commission
finding on acceptance criteria will continue to be addressed separately
in Sec. 52.103(g) (proposed Sec. 52.231(g)).
In a letter dated February 22, 1993, the Nuclear Management and
Resources Council, Inc. (NUMARC) stated:
2.229(e)) state that the NRC staff
shall be responsible for ensuring that inspections, tests and analyses
in the ITAAC have been performed. The requirement for a Commission
finding on acceptance criteria will continue to be addressed separately
in Sec. 52.103(g) (proposed Sec. 52.231(g)).
In a letter dated February 22, 1993, the Nuclear Management and
Resources Council, Inc. (NUMARC) stated:

There is nothing in Title XXVIII or its legislative history
which compels a change in the Staff responsibilities from that
reflected in prior Sec. 52.99. Indeed, any other implementation of
Sec. 52.99 would be wholly unworkable. Accordingly, it is our
understanding that the reference to ``the Commission'' in amended
Sec. 52.99 is to be read as authorizing the Commission to delegate
to the Staff the responsibility for overseeing ITAAC performance
during the period of facility construction; and further that this is
the Commission's intention. Responsibility for the pre-operational
finding of acceptance criteria conformance would, of course, be the
responsibility of the Commission, as reflected in both amended
Sec. Sec. 52.99 and 52.103(g).

The proposed rule is consistent with NUMARC's recommendation.
The requirements in the proposed Sec. 52.229(e) will be limited to
the responsibilities of the NRC staff. The staff will ensure that the
inspections, tests, and analyses in the ITAAC have been performed and
will publish notices in the Federal Register of the successful
completion of inspections, tests, and analyses. The NRC staff will
perform periodic inspections during construction of the facility and
implementation of the licensee's operational programs, e.g., emergency
planning and training. The NRC staff will issue reports on these
inspections and will make these reports publically available. At the
conclusion of construction, the staff will make a recommendation to the
Commission on its assessment of the licensee's completion of ITAAC
inspections during construction of the facility and
implementation of the licensee's operational programs, e.g., emergency
planning and training. The NRC staff will issue reports on these
inspections and will make these reports publically available. At the
conclusion of construction, the staff will make a recommendation to the
Commission on its assessment of the licensee's completion of ITAAC. If
the Commission determines that all of the acceptance criteria in the
ITAAC for the combined license have been met, it will make the finding
required under proposed Sec. 52.231(g).
Consistent with the language in proposed Sec. 52.229(e), the
proposed rule would also amend the current Sec. 52.83 (proposed Sec.
52.215(c)) to state that the requirements in 10 CFR part 50 that are
applicable to holders of operating licenses become applicable to
holders of combined licenses after the Commission's finding of
successful ITAAC completion under current Sec. 52.103(g) (proposed
Sec. 52.231(g)), rather than referring to the Commission finding under
the current Sec. 52.99. As discussed above, the Commission's 1992
rulemaking amended Sec. 52.99 to refer to the Commission's finding of
ITAAC completion, and amended Sec. 52.83 to refer to the Commission's
finding under Sec. 52.99. Inasmuch as the Commission finding and
authorization of operation would be addressed in proposed Sec.
52.231(g), it follows that proposed Sec. 52.215(c) should refer to the
Commission's authorization of operation under Sec. 52.231(g) rather
than the NRC staff's activities under proposed Sec. 52.229(e).
Combined License Change Process
The proposed rule would amend the current Sec. 52.97 (proposed
Sec. 52.227) 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. This amendment will add Sec
ation under Sec. 52.231(g) rather
than the NRC staff's activities under proposed Sec. 52.229(e).
Combined License Change Process
The proposed rule would amend the current Sec. 52.97 (proposed
Sec. 52.227) 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. This amendment will add Sec.
52.227(c), which states that the change processes in 10 CFR part 50
apply to a combined license that does not reference a design
certification rule. This amendment will also add Sec. 52.227(d), which
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.
In a letter dated November 13, 2001 (comment 21(a)(2)), NEI
recommended that proposed Sec. Sec. 52.227(c) and (d)(2) state that
changes outside the scope of a certified design are subject to ``the
applicable change control requirements in 10 CFR part 50, e.g., 10 CFR
50.59, 50.54 or 50.90.'' The Commission has decided to propose this
amendment to clarify which change processes are applicable to a
combined license and this amendment is consistent with NEI's
recommendation.
Design Certifications for ABWR, System 80+, and AP600
The proposed rule would amend paragraphs VI.B.4, 5, and 6 of the
three design certification rules in 10 CFR part 52, Appendices A, B,
and C (for 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
nd paragraphs VI.B.4, 5, and 6 of the
three design certification rules in 10 CFR part 52, Appendices A, B,
and C (for 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
design certification rule are resolved when an exemption has been
granted for a plant referencing the design certification rule.
Paragraph VI.B.5 describes how issues are resolved when a plant
referencing the design certification rule 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 get NRC approval. Thus, once a matter (e.g., an
exemption in the

case of paragraph VI.B.4) was addressed for a specific plant
referencing a design certification rule, the adequacy of that matter
for that plant would not 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.
Unfortunately, the three design certification rules use the phrase
``but only for that proceeding,'' which may lead to the erroneous
conclusion that issue resolution exists only in the proceeding in which
the matter was approved and/or adjudicated, and not in all subsequent
proceedings for that plant
V.B, but there would not be
any issue resolution on that subject matter for any other plant.
Unfortunately, the three design certification rules use the phrase
``but only for that proceeding,'' which may lead to the erroneous
conclusion that issue resolution exists only in the proceeding in which
the matter was approved and/or adjudicated, and not in all subsequent
proceedings for that plant.
In letters dated November 12, 2001, and November 13, 2001,
respectively, General Electric Company and Westinghouse Electric
Company reiterated earlier recommendations the two companies had made
that Sections VI.B.4 and 5 of the design certification rules state that
exemptions and license amendments have finality ``but only for that
plant.'' For the reasons discussed above, the Commission agrees, and
the Commission proposes to substitute the phrase ``but only for that
plant,'' in order to clarify that issue resolution on a matter applies
in subsequent proceedings for that plant.
Each of the design certification rules in 10 CFR part 52
(Appendices A, B, and C) includes a Section VIII on change processes.
These processes apply to changes depending upon the category of design
information affected. For plant-specific tier 2 information, the change
process established in the rules mirrors, in large part, that in the
former 10 CFR 50.59. The proposed rule would amend paragraph VIII.B.5
of the design certification rules to conform the terminology in the
50.59-like change process to that used in the revised Sec. 50.59. This
amendment deletes references to unreviewed safety question and safety
evaluation, and conforms the evaluation criteria concerning when prior
NRC approval is needed. Also, a definition has been added (paragraph
II.G) for ``departure from a method of evaluation'' to support the
evaluation criterion in VIII.B.5.b(8).
In an earlier rulemaking (see 64 FR 53582; October 4, 1999), the
Commission revised Sec
deletes references to unreviewed safety question and safety
evaluation, and conforms the evaluation criteria concerning when prior
NRC approval is needed. Also, a definition has been added (paragraph
II.G) for ``departure from a method of evaluation'' to support the
evaluation criterion in VIII.B.5.b(8).
In an earlier rulemaking (see 64 FR 53582; October 4, 1999), the
Commission revised Sec. 50.59 to incorporate new thresholds for
permitting changes to a plant as described in the final safety analysis
report without NRC approval. For consistency and clarity, similar
changes are now being proposed for 10 CFR part 52 applicants or
licensees. Because of some differences in how the change control
requirements are structured in the design certification rules, certain
definitions contained in Sec. 50.59 are not necessary for or
applicable to 10 CFR part 52 and are not being included in this
proposed rule. One definition that the Commission is including is the
definition from the new Sec. 50.59 for a ``departure from a method of
evaluation,'' which is appropriate to include in this rulemaking so
that the eighth criterion in Section VIII.B.5.b of the design
certification rules will be implemented as intended.

B. 10 CFR Part 2, Rules of Practice for Domestic Licensing Proceedings
and Issuance of Orders

The proposed rule would amend Sec. Sec. 2.110, 2.400, 2.401,
2.402, 2.403, 2.404, 2.406, 2.500, 2.501, and 2.502 to correct
references to former 10 CFR part 52 appendices that have been
redesignated as subparts.

C. 10 CFR Part 20, Standards for Protection Against Radiation

The proposed rule would amend Sec. 20.1002 to clarify that the
regulations in 10 CFR part 20 also apply to licenses issued under 10
CFR part 52. This conforming change was inadvertently overlooked when
the Commission originally promulgated 10 CFR part 52.

D. 10 CFR Part 21, Reporting of Defects and Noncompliance
ated as subparts.

C. 10 CFR Part 20, Standards for Protection Against Radiation

The proposed rule would amend Sec. 20.1002 to clarify that the
regulations in 10 CFR part 20 also apply to licenses issued under 10
CFR part 52. This conforming change was inadvertently overlooked when
the Commission originally promulgated 10 CFR part 52.

D. 10 CFR Part 21, Reporting of Defects and Noncompliance

The proposed rule would amend Sec. Sec. 21.2, 21.3, and 21.21 to
clarify the applicability of 10 CFR part 21 to individuals,
corporations, partnerships, or other entities doing business within the
United States, and directors and responsible officers of such
organizations, that hold a permit or license under 10 CFR part 52.
These conforming changes would correct an oversight when the Commission
first adopted 10 CFR part 52, to ensure that the requirements in 10 CFR
part 21 apply to applicants for, and holders of licenses under 10 CFR
part 52, as well as to suppliers of basic components to such licensees.
Combined Licenses, Manufacturing Licenses, Duplicate Design Licenses
The proposed rule would make 10 CFR part 21 applicable to
applicants for, and holders of combined licenses, manufacturing
licenses, and duplicate design licenses under 10 CFR part 52, and
suppliers of basic components to such applicants and holders, by
amending paragraphs (a), (b), and (c) of Sec. 21.2 regarding the scope
of 10 CFR part 21 and amending the definitions of basic component,
commercial grade item, critical characteristics, dedicating entity,
dedication, defect, and substantial safety hazard in Sec. 21.3. In
addition, the proposed rule would amend Sec
part 52, and
suppliers of basic components to such applicants and holders, by
amending paragraphs (a), (b), and (c) of Sec. 21.2 regarding the scope
of 10 CFR part 21 and amending the definitions of basic component,
commercial grade item, critical characteristics, dedicating entity,
dedication, defect, and substantial safety hazard in Sec. 21.3. In
addition, the proposed rule would amend Sec. 21.21 to clearly state
when a director or responsible officer subject to 10 CFR part 21 must
notify the Commission that the director or officer has information
reasonably indicating a failure to comply or a defect affecting the
construction or operation of a facility or an activity that is subject
to the licensing requirements under 10 CFR part 52 or affecting a basic
component supplied for a facility or an activity that is subject to the
licensing requirements under 10 CFR part 52. The Commission notes that
a supplier of safety-related analyses and services to a licensee under
part 52 is subject to part 21, inasmuch as such services constitute
``basic components;'' this is no different than the applicability of
part 21 to a supplier of such analyses and services to a licensee under
part 50.
Early Site Permits
With respect to early site permits, the Commission proposes to use
a different approach, such that the requirements of part 21 do not
apply to applicants for early site permits, or holders of early site
permits so long as the early site permit is not referenced in any
license application. During the pendency of the early site permit
application before the NRC, the applicant would be required by 10 CFR
50.9, ``Completeness and accuracy of information,'' to notify the
Commission of any information having a ``significant implication for
public health and safety or the common defense and security'' with
respect to the matters covered in the application, pursuant to proposed
Sec. 52.111. Failure to abide by the completeness and accuracy
requirements in Sec
applicant would be required by 10 CFR
50.9, ``Completeness and accuracy of information,'' to notify the
Commission of any information having a ``significant implication for
public health and safety or the common defense and security'' with
respect to the matters covered in the application, pursuant to proposed
Sec. 52.111. Failure to abide by the completeness and accuracy
requirements in Sec. 50.9 would subject the applicant to potential
criminal liability under Sec. 52.113 (proposed Sec. 52.403). In
addition, under current Sec. 52.9, the early site permit applicant
would be subject to penalties for deliberate misconduct, including
submission to the NRC of information known to be incomplete or
inaccurate in some material aspect. Finally, during the pendency of an
early site permit application, the application has no operative effect
with respect to issue resolution under Sec. 52.39; consequently, an
early site permit application itself could not result in a
``substantial safety hazard'' by virtue of the application being
referenced in a nuclear power plant licensing proceeding. Therefore,
the Commission does not believe that adopting the regulatory overlay of
part 21 during the pendency of an early site permit application is
necessary to effectuate the Commission's regulatory

responsibilities under the AEA, as amended, including providing
reasonable assurance of adequate protection of public health and safety
or common defense and security.
The Commission does not believe that part 21 should apply to the
early site permit holder after the early site permit has been issued,
but before the holder has referenced the permit in a license
application.\2\ With one exception, the early site permit does not
authorize any action by the holder with respect to the construction or
operation of a nuclear power plant
mon defense and security.
The Commission does not believe that part 21 should apply to the
early site permit holder after the early site permit has been issued,
but before the holder has referenced the permit in a license
application.\2\ With one exception, the early site permit does not
authorize any action by the holder with respect to the construction or
operation of a nuclear power plant. The exception is when the early
site permit authorizes the holder to conduct the site preparation
activities permitted under 10 CFR 50.10(e)(1) (commonly referred to as
limited work authorization-1, or LWA-1, activities). However, these
activities are related to site clearing and preparation, and do not
permit any construction (including subsurface preparation) for
``structures, systems and components which prevent or mitigate the
consequences of postulated accidents that could cause undue risk to the
health and safety of the public.'' Thus, the conduct of LWA-1
activities do not appear to have any reasonable possibility of
resulting in a ``substantial safety hazard.'' Furthermore, the inherent
nature of an early site permit is site-specific and not susceptible to
generic or wide-ranging applicability. For these reasons, the
Commission proposes that part 21 should not apply to an early site
permit holder until the permit is referenced by a license applicant.
---------------------------------------------------------------------------
stantial safety hazard.'' Furthermore, the inherent
nature of an early site permit is site-specific and not susceptible to
generic or wide-ranging applicability. For these reasons, the
Commission proposes that part 21 should not apply to an early site
permit holder until the permit is referenced by a license applicant.
---------------------------------------------------------------------------

\2\ The Commission would not permit a license applicant to
reference an early site permit which it does not hold (or has rights
to the permit contingent upon a NRC decision to issue a license
whose application references the early site permit). To otherwise
permit referencing of an early site permit by a non-holder would
destroy the commercial value of the permit, and would prevent any
entity from seeking an early site permit. This would frustrate the
Commission's regulatory objective of providing early regulatory
approval of siting, emergency preparedness, and environmental
matters. Since the early site permit is a license, the relevant
requirements of part 21 are those applicable to a licensee.
---------------------------------------------------------------------------

Once an early site permit holder references the permit in a license
application, the Commission believes that the holder should be subject
to part 21. The Commission's safety review of a license application
referencing an early site permit is limited in accordance with
Sec. Sec. 52.39 and 52.79 (proposed Sec. 52.211), under the precept
that the site parameters, terms, and conditions which define the
envelope for safe siting of a nuclear power plant have been determined
by the NRC in the early site permit proceeding
d be subject
to part 21. The Commission's safety review of a license application
referencing an early site permit is limited in accordance with
Sec. Sec. 52.39 and 52.79 (proposed Sec. 52.211), under the precept
that the site parameters, terms, and conditions which define the
envelope for safe siting of a nuclear power plant have been determined
by the NRC in the early site permit proceeding. If the early site
permit holder discovers a significant safety concern with respect to
its site (e.g., that the specified site parameter 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 the application referencing the early
site permit. This reporting attains special importance given the
Commission's proposal (see discussion in Section III.A.8 on referencing
an early site permit) not to impose an updating requirement for early
site permit information other than that related to emergency
preparedness. Accordingly, the Commission concludes that the early site
permit holder should be subject to part 21 once it references the
permit in a license application.
The Commission believes that changes to part 21 are unnecessary to
reflect these determinations with respect to early site permit
applicants and holders. A licensee's reporting requirements in part 21
apply only with respect to ``basic components'' used or to be used in
an NRC-licensed or otherwise regulated facility. The safety-related
analyses and consulting services supplied to an applicant for an early
site permit appear to fall within the definition of ``basic
component,'' in that they constitute ``safety-related design [and]
analyses * * * associated with component hardware'' (See 10 CFR 21.3,
``Basic component,'' paragraph (3)). Thus, part 21 could be interpreted
as applying to the early site permit holder immediately upon the
permit's issuance
ices supplied to an applicant for an early
site permit appear to fall within the definition of ``basic
component,'' in that they constitute ``safety-related design [and]
analyses * * * associated with component hardware'' (See 10 CFR 21.3,
``Basic component,'' paragraph (3)). Thus, part 21 could be interpreted
as applying to the early site permit holder immediately upon the
permit's issuance. However, there appears to be little reasonable
likelihood of a ``substantial safety hazard'' unless and until the
early site permit has been referenced by the permit holder in a license
application. Once the early site permit has been referenced, the
potential for a substantial safety hazard clearly exists if a known
defect in site parameters, terms, or conditions defining the envelope
for safe plant operation is not disclosed, and a plant is designed,
constructed, and allowed to operate which does not reflect the actual
limiting parameters and conditions of the site. Thus, no changes to
part 21 are necessary to reflect the Commission's intent.
The Commission also proposes that part 21 apply to suppliers of
safety-related analyses and services to an early site permit holder in
the same manner and extent as part 21 applies to the early site permit
holder. Such suppliers would be subject to part 21 only after the early
site permit holder references the permit in a license application.
Design Certification Rules
Similar to the approach for early site permit applicants and
holders, the Commission proposes that the requirements in part 21
should not apply to the applicant/vendor for a design certification
(and/or its successors) during the pendency of its design certification
application
only after the early
site permit holder references the permit in a license application.
Design Certification Rules
Similar to the approach for early site permit applicants and
holders, the Commission proposes that the requirements in part 21
should not apply to the applicant/vendor for a design certification
(and/or its successors) during the pendency of its design certification
application. During the pendency of the design certification
application, the applicant/vendor would be required by 10 CFR 50.9,
``Completeness and accuracy of information,'' to notify the Commission
of any information having a ``significant implication for public health
and safety or the common defense and security'' with respect to the
matters covered in the application, pursuant to proposed Sec. 52.111.
Failure to abide by the completeness and accuracy requirements in Sec.
50.9 would subject the applicant/vendor to potential criminal liability
under Sec. 52.113 (proposed Sec. 52.403). In addition, under current
Sec. 52.9, the applicant for a design certification is subject to
penalties for deliberate misconduct, including submission to the NRC of
information known to be incomplete or inaccurate in some material
aspect. Finally, during the pendency of a design certification
application, the application has no operative effect with respect to
issue resolution under current Sec. 52.63 (proposed Sec. 52.127);
consequently, a design certification application itself could not
result in a ``substantial safety hazard'' by virtue of the application
being referenced in a nuclear power plant licensing proceeding.
Therefore, the Commission does not believe that adopting the regulatory
overlay of part 21 during the pendency of a design certification
application is necessary to effectuate the Commission's regulatory
responsibilities under the AEA, as amended, including providing
reasonable assurance of adequate protection to public health and safety
or common defense and security
t licensing proceeding.
Therefore, the Commission does not believe that adopting the regulatory
overlay of part 21 during the pendency of a design certification
application is necessary to effectuate the Commission's regulatory
responsibilities under the AEA, as amended, including providing
reasonable assurance of adequate protection to public health and safety
or common defense and security.
The Commission also believes that the reporting requirements in
part 21 should not apply to the design certification applicant/vendor
after the Commission issuance of a final design certification rule but
before the design certification rule is referenced by at least one
applicant/licensee (nor should either Sec. Sec. 52.9 or 52.111 be
modified to make them applicable to the design certification applicant/
vendor). The Commission does not believe that a design certification
rule would reasonably result in a ``substantial safety hazard'' so long
as the design certification rule is not actually referenced in a
license application (and

thereafter incorporated by reference into a license). It is true that,
unlike an early site permit, a design certification rule is of general
applicability and that a complete nuclear power plant design could be
provided by an entity other than the original design certification
applicant/vendor (see Sec. 52.73 (proposed Sec. 52.203)).
Nonetheless, unless the other entity provides a design which is
subsequently referenced in an NRC license application, there is no
``substantial safety hazard'' created (although the Commission
acknowledges that the entity may incur significant redesign costs if
the entity completes substantial parts of the design before submission
of the application, only to find upon submission of the application
that there were significant defects in the certified design)
sequently referenced in an NRC license application, there is no
``substantial safety hazard'' created (although the Commission
acknowledges that the entity may incur significant redesign costs if
the entity completes substantial parts of the design before submission
of the application, only to find upon submission of the application
that there were significant defects in the certified design). Upon
weighing of all relevant factors, the Commission proposes that part 21
should not apply to the design certification applicant/vendor until a
final, Commission-approved design certification rule is referenced by
at least one applicant/licensee.
However, the Commission believes that once a design certification
rule is referenced by an applicant, the design certification applicant/
vendor should be subject to part 21. The Commission's safety review of
a license application referencing a design certification rule is
limited in accordance with Sec. 52.63 (proposed Sec. 52.127) and
Sec. 52.79 (proposed Sec. 52.211). If the design certification
applicant/vendor has discovered a significant safety concern with
respect to its certified design, it should be reported to the NRC so
that it may be considered in the review of the application referencing
the design certification rule. While this places a continuing
obligation on the design certification applicant/vendor to monitor
whether its design has been referenced in a license application, as a
practical matter it is likely that the license applicant will have
contractually engaged the design certification applicant/vendor prior
to submitting the application. In any event, the Commission concludes
that the design certification applicant/vendor should be subject to
part 21 after its design certification has been referenced by an
applicant for a license.
The Commission believes that, with o

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/FR_PRORULE_03-16413. Check the current official text before relying on it. Not legal advice.