[Federal Register Volume 76, Number 57 (Thursday, March 24, 2011)]
[Proposed Rules]
[Pages 16549-16570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-6839]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 76, No. 57 / Thursday, March 24, 2011 / 
Proposed Rules  

[[Page 16549]]



NUCLEAR REGULATORY COMMISSION

10 CFR Part 52

[NRC-2010-0135]
RIN 3150-AI85


ESBWR Design Certification

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or Commission) 
proposes to amend its regulations to certify the Economic Simplified 
Boiling-Water Reactor (ESBWR) standard plant design. This action is 
necessary so that applicants or licensees intending to construct and 
operate an ESBWR design may do so by referencing this design 
certification rule (DCR). The applicant for certification of the ESBWR 
design is GE-Hitachi Nuclear Energy (GEH). The public is invited to 
submit comments on this proposed DCR, the generic design control 
document (DCD) that would be incorporated by reference into the DCR, 
and the environmental assessment (EA) for the ESBWR design.

DATES: Submit comments on the DCR, DCD and/or EA by June 7, 2011. 
Submit comments specific to the information collections aspects of this 
rule by April 25, 2011. Comments received after the above dates will be 
considered if it is practical to do so, but assurance of consideration 
cannot be given to comments received after these dates.

ADDRESSES: Please include Docket ID NRC-2010-0135 in the subject line 
of your comments. For instructions on submitting comments and accessing 
documents related to this action, see Section I, ``Submitting Comments 
and Accessing Information'' in the SUPPLEMENTARY INFORMATION section of 
this document. You may submit comments by any one of the following 
methods.
     Federal rulemaking Web site: Go to http://www.regulations.gov and search for documents filed under Docket ID NRC-
2010-0135. Address questions about NRC dockets to Carol Gallagher, 
telephone: 301-492-3668; e-mail: [email protected].
     Mail comments to: Secretary, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, ATTN: Rulemakings and 
Adjudications Staff.
     E-mail comments to: [email protected]. If you do 
not receive a reply e-mail confirming that we have received your 
comments, contact us directly at 301-415-1966.
     Hand Deliver comments to: 11555 Rockville Pike, Rockville, 
Maryland 20852 between 7:30 a.m. and 4:15 p.m. during Federal workdays 
(telephone: 301-415-1966).
     Fax comments to: Secretary, U.S. Nuclear Regulatory 
Commission at 301-415-1101.

FOR FURTHER INFORMATION CONTACT: George M. Tartal, Office of New 
Reactors, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001; telephone: 301-415-0016; e-mail: [email protected]; or Bruce 
M. Bavol, Office of New Reactors, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001; telephone: 301-415-6715; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Submitting Comments and Accessing Information
II. Background
III. Regulatory and Policy Issues
IV. Technical Evaluation of the ESBWR
V. Section-by-Section Analysis
    A. Introduction (Section I)
    B. Definitions (Section II)
    C. Scope and Contents (Section III)
    D. Additional Requirements and Restrictions (Section IV)
    E. Applicable Regulations (Section V)
    F. Issue Resolution (Section VI)
    G. Duration of This Appendix (Section VII)
    H. Processes for Changes and Departures (Section VIII)
    I. Inspections, Tests, Analyses, and Acceptance Criteria (ITAAC) 
(Section IX)
    J. Records and Reporting (Section X)
VI. Agreement State Compatibility
VII. Availability of Documents
VIII. Procedures for Access to Proprietary Information, Sensitive 
Unclassified Non-Safeguards Information (Including Proprietary 
Information) and Safeguards Information for Preparation of Comments 
on the Proposed ESBWR Design Certification Rule
IX. Plain Language
X. Voluntary Consensus Standards
XI. Finding of No Significant Environmental Impact: Availability
XII. Paperwork Reduction Act Statement
XIII. Regulatory Analysis
XIV. Regulatory Flexibility Certification
XV. Backfitting

I. Submitting Comments and Accessing Information

    Comments submitted in writing or in electronic form will be posted 
on the NRC Web site and on the Federal rulemaking Web site, http://www.regulations.gov. Because your comments will not be edited to remove 
any identifying or contact information, the NRC cautions you against 
including any information in your submission that you do not want to be 
publicly disclosed. The NRC requests that any party soliciting or 
aggregating comments received from other persons for submission to the 
NRC inform those persons that the NRC will not edit their comments to 
remove any identifying or contact information, and therefore, they 
should not include any information in their comments that they do not 
want publicly disclosed.
    Documents that are not publicly available because they are 
considered to be either Sensitive Unclassified Non-Safeguards 
Information (SUNSI) (including SUNSI constituting ``proprietary 
information'' \1\) or Safeguards Information (SGI) may be available to 
interested persons who may wish to comment on the proposed design 
certification. Such persons shall follow the procedures described in 
the Supplementary Information section of this notice, under the 
heading, ``VIII. Procedures for Access to SUNSI (Including Proprietary 
information) and Safeguards Information for Preparation of Comments on 
the Proposed ESBWR Design Certification Rule.''
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    \1\ For purposes of this discussion, ``proprietary information'' 
constitutes trade secrets or commercial or financial information 
that are privileged or confidential, as those terms are used under 
the Freedom of Information Act (FOIA) and the NRC's implementing 
regulation at Title 10 of the Code of Federal Regulations (10 CFR), 
part 9.
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    You can access publicly available documents related to this 
document, including the following documents, using the following 
methods:
     NRC's Public Document Room (PDR): The public may examine 
and have copied, for a fee, publicly available documents at the NRC's 
PDR, Room O-1F21, One White Flint North, 11555

[[Page 16550]]

Rockville Pike, Rockville, Maryland 20852.
     NRC's Agencywide Documents Access and Management System 
(ADAMS): Publicly available documents created or received at the NRC 
are available electronically at the NRC's Electronic Reading Room at 
http://www.nrc.gov/reading-rm/adams.html. From this page, the public 
can gain entry into ADAMS, which provides text and image files of NRC's 
public documents. If you do not have access to ADAMS or if there are 
problems in accessing the documents located in ADAMS, contact the NRC's 
PDR reference staff at 1-800-397-4209, or 301-415-4737, or by e-mail to 
[email protected].
     Federal Rulemaking Web Site: Public comments and 
supporting materials related to this proposed rule can be found at 
http://www.regulations.gov by searching on Docket ID NRC-2010-0135.

II. Background

    Subpart B to 10 CFR part 52 sets forth the process for obtaining 
standard design certifications. On August 24, 2005 (70 FR 56745), GEH 
tendered its application for certification of the ESBWR standard plant 
design with the NRC. The GEH submitted this application in accordance 
with Subpart B of 10 CFR part 52. The NRC formally accepted the 
application as a docketed application for design certification (Docket 
No. 52-010) on December 1, 2005 (70 FR 73311). The pre-application 
information submitted before the NRC formally accepted the application 
can be found in ADAMS under Docket No. PROJ0717 (Project No. 717).
    The application for design certification of the ESBWR design has 
been referenced in the following combined license (COL) application as 
of the date of this document:
    Detroit Edison Company, Fermi Unit 3, Docket No. 52-033 (73 FR 
73350; December 2, 2008).

III. Regulatory and Policy Issues

Human Factors Operational Programs

    The NRC is implementing existing Commission policy, that 
operational programs should be excluded from finality except where 
necessary to find design elements acceptable, in a manner different 
from other existing design certification rules. This policy is 
described in the December 6, 1996, staff requirements memorandum (SRM) 
to SECY-96-077, ``Certification of Two Evolutionary Designs,'' dated 
April 15, 1996. The NRC proposes to exclude the two Human Factors 
Engineering (HFE) operational program elements in Chapter 18 of the 
ESBWR DCD from the scope of the design approved in the rule. There are 
12 elements in the HFE program. Two of the elements concern operational 
programs (procedures and training) that are not used to assess the 
adequacy of the HFE design. However, the GEH description of these two 
HFE operational programs addresses existing NRC guidelines in NUREG-
0711, Revision 2, ``Human Factors Engineering Program Review Model,'' 
which are comprehensive, and go beyond the operational program 
information needed as input to the HFE design. In addition, the 
training and procedure elements included in the HFE program are 
redundant to what is reviewed as part of the operational programs 
described in Chapter 13 of the Standard Review Plan (NUREG-0800). 
Accordingly, the NRC is revising the HFE regulatory guidance in NUREG-
0711 to address this overlap, but the revised guidance is not expected 
to be completed until late 2011. In keeping with the established 
Commission policy of not approving operational program elements through 
design certification except where necessary to find design elements 
acceptable, the NRC proposes to exclude the two HFE operational program 
elements in the ESBWR DCD from the scope of the design approved in the 
rule. This would be done explicitly in Section VI, Issue Resolution, of 
the rule, by excluding the two HFE operational program elements from 
the finality accorded to the design. This exclusion would be unique to 
the ESBWR design because all other DCDs for the previously certified 
designs do not include operational program descriptions of HFE training 
and procedures and the respective DCRs did not include specific 
exclusions from finality for it.

Access to SUNSI and SGI in Connection With License Applications

    In the four currently approved design certifications (10 CFR part 
52, Appendices A through D), paragraph VI.E sets forth specific 
directions on how to obtain access to proprietary information and SGI 
on the design certification in connection with a license application 
proceeding referencing that design certification rule. These provisions 
were developed before the events of September 11, 2001. After September 
11, 2001, Congress has changed the statutory requirements governing 
access to SGI, and the NRC has revised its rules, procedures, and 
practices governing control of and access to SUNSI and SGI. The NRC now 
believes that generic direction on obtaining access to SUNSI and SGI is 
no longer appropriate for newly approved DCRs. Accordingly, the 
specific requirements governing access to SUNSI and SGI contained in 
paragraph VI.E of the four currently approved DCRs should not be 
included in the design certification rule for the ESBWR. Instead, the 
NRC should specify the procedures to be used for obtaining access at an 
appropriate time in the COL proceeding referencing the ESBWR DCR. The 
NRC intends to include this change in any future amendment or renewal 
of the existing DCRs. However, the NRC is not planning to initiate 
rulemaking to change paragraph VI.E of the existing DCRs, in order to 
minimize unnecessary resource expenditures by both the original DCR 
applicant and the NRC.

IV. Technical Evaluation of the ESBWR

    The NRC issued a final safety evaluation report (FSER) for the 
ESBWR design in March 2011. The FSER provides the basis for issuance of 
a design certification under Subpart B to 10 CFR part 52 and a final 
design approval under Subpart E to 10 CFR part 52. The GEH has 
requested the NRC provide its design approval for the ESBWR design 
under Subpart E. The final design approval for the ESBWR design will be 
issued before publication of a final rule.
    The significant technical issues that were resolved during the 
review of the ESBWR design are the regulatory treatment of non-safety 
systems (RTNSS), containment performance, control room cooling, steam 
dryer methodology, feedwater temperature (FWT) domain, aircraft impact 
assessment and the use of Code Case N-782.

Regulatory Treatment of Non-Safety Systems

    The ESBWR relies on passive systems to perform safety functions 
credited in the design basis for 72 hours following an initiating 
event. After 72 hours, non-safety systems, either passive or active, 
replenish the passive systems in order to keep them operating or 
perform post-accident recovery functions directly. The ESBWR design 
also uses nonsafety-related active systems to provide defense-in-depth 
capabilities for key safety functions provided by passive systems. The 
challenge during the review was to identify the non-safety systems, 
structures and components (SSCs) that should receive enhanced 
regulatory treatment and to identify the appropriate regulatory 
treatment to be applied to these SSCs. Such SSCs are denoted as ``RTNS 
SSCs.'' As a result of

[[Page 16551]]

the NRC's review, the applicant added Appendix 19A to the DCD to 
identify the nonsafety systems that perform these post-72 hour or 
defense-in-depth functions and the basis for their selection. The 
applicant's selection process was based on the guidance in SECY-94-084, 
``Policy and Technical Issues Associated with the Regulatory Treatment 
of Non-Safety Systems in Passive Plant Designs.''
    To provide reasonable assurance that RTNSS SSCs will be available 
if called upon to function, the applicant established availability 
controls in DCD Tier 2, Appendix 19ACM, and Technical Specifications 
(TS) in DCD Tier 2, Chapter 16, when required by 10 CFR 50.36. The 
applicant also included all RTNSS SSCs in the reliability assurance 
program described in Chapter 17 of DCD Tier 2 and applied augmented 
design standards as described in DCD Tier 2, Section 19A.8.3. The NRC 
finds the applicant's implementation of the RTNSS process described in 
the DCD acceptable.

Containment Performance

    The passive containment cooling system (PCCS) maintains the 
containment within its design pressure and temperature limits for 
design-basis accidents. The system is passive and does not rely upon 
moving components or external power for initiation or operation for 72 
hours following a loss-of-coolant accident (LOCA). The PCCS and its 
design basis are described in detail in Section 6.2.2 of the DCD Tier 
2. The NRC identified a concern regarding the PCCS long-term cooling 
capability for the period from 72 hours to 30 days following a LOCA. To 
address this concern, the applicant proposed additional design features 
credited after 72 hours to reduce the long-term containment pressure. 
The features are the PCCS vent fans and passive autocatalytic 
recombiners as described in DCD Tier 2, Section 6.2.1. These SSCs have 
been indentified in DCD Appendix 19A as RTNSS SSCs.
    The applicant provided calculation results to demonstrate that the 
long-term containment pressure would be acceptable and that the design 
complies with general design criterion (GDC) 38. The NRC's independent 
calculations confirmed the applicant's conclusion and the NRC accepts 
the proposed design and licensing basis. The NRC also raised a concern 
regarding the potential accumulation of high concentrations of hydrogen 
and oxygen in the PCCS and isolation condenser system (ICS), which 
could lead to combustion following a LOCA. The applicant modified the 
design of the PCCS and ICS heat exchangers to withstand potential 
hydrogen detonations. The NRC concludes that the design changes to the 
PCCS and ICS are acceptable and meet the applicable requirements.

Control Room Cooling

    The ESBWR primarily relies on the mass and structure of the control 
building to maintain acceptable temperatures for human and equipment 
performance for up to 72 hours on loss of normal cooling. The NRC had 
not previously approved this approach for maintaining acceptable 
temperatures in the control building. The applicant proposed acceptance 
criteria for the evaluation of the control building structure's thermal 
performance based on industry and NRC guidelines. The applicant 
incorporates by reference an analysis of the control building 
structure's thermal performance as described in Tier 2, Sections 3H, 
6.4, and 9.4. The applicant also proposed ITAAC to confirm that an 
updated analysis of the as-built structure continues to meet the 
thermal performance acceptance criteria. The NRC finds that the 
applicant's acceptance criteria are consistent with the advanced light-
water reactor control room envelope atmosphere temperature limits in 
NUREG-1242, ``NRC Review of Electric Power Research Institute's 
Advanced Light Water Reactor Utility Requirements Document,'' and the 
use of the wet bulb globe temperature index in evaluation of heat 
stress conditions as described in NUREG-0700, ``Human-System Interface 
Design Review Guidelines.'' The NRC finds the control building 
structure thermal performance analysis and ITAAC acceptable based on 
the analysis using bounding environmental assumptions which will be 
confirmed by the ITAAC. Accordingly, the NRC finds that the acceptance 
criteria, control building structure thermal performance analysis, and 
the ITAAC, provide reasonable assurance that acceptable temperatures 
will be maintained in the control building for 72 hours. Therefore, the 
NRC finds that the control building design in regard to thermal 
performance conforms to the guidelines of Standard Review Plan Section 
6.4 and complies with the requirements of the general design criteria 
of 10 CFR part 50, Appendix A, GDC 19.

Feedwater Temperature Operating Domain

    In operating boiling-water reactors the recirculation pumps are 
used in combination with the control rods to control and maneuver 
reactor power level during normal power operation. The ESBWR design is 
unique in that the core is cooled by natural circulation during normal 
operation, and there are no recirculation pumps. In Chapter 15 of the 
DCD, GEH references the licensing topical report (LTR) NEDO-33338, 
Revision 1, ``ESBWR Feedwater Temperature Operating Domain Transient 
and Accident Analysis.'' This LTR describes a broadening of the ESBWR 
operating domain, which allows for increased flexibility of operation 
by adjusting the FWT. This increased flexibility accommodates the so-
called ``soft'' operating practices, which reduce the duty (mechanical 
stress) to the fuel and minimize the probability of pellet-clad 
interactions and associated fuel failures.
    By adjusting the FWT, the operator can control the reactor power 
level without control blade motion and with minimum impact on the fuel 
duty. Control blade maneuvering can also be performed at lower power 
levels.
    To control the FWT, the ESBWR design includes a seventh feedwater 
heater with high-pressure steam. FWT is controlled by either 
manipulating the main steam flow to the No. 7 feedwater heater to 
increase FWT above the temperature normally provided by the feedwater 
heaters with turbine extraction steam (normal FWT) or by directing a 
portion of the feedwater flow around the high-pressure feedwater 
heaters to decrease FWT below the normal FWT. An increase in FWT 
decreases reactor power, and a decrease in FWT increases reactor power. 
The applicant provided analyses that demonstrated ample margin to 
acceptance criteria. The NRC concludes that the applicant has 
adequately accounted for the effects of the proposed FWT operating 
domain extension on the nuclear design. Further, the applicant has 
demonstrated that the fuel design limits will not be exceeded during 
normal or anticipated operational transients and that the effects of 
postulated transients and accidents will not impair the capability to 
cool the core. Based on this evaluation, the NRC concludes that the 
nuclear design of the fuel assemblies, control systems, and reactor 
core will continue to meet the applicable regulatory requirements.

Steam Dryer Design Methodology

    As a result of reactor pressure vessel (RPV) steam dryer issues at 
operating BWRs, the NRC issued revised guidance concerning the 
evaluation of steam dryers. The guidance requested analysis to show 
that the dryer will maintain its structural integrity during plant 
operation in spite of or in the face of

[[Page 16552]]

acoustic and hydrodynamic fluctuating pressure loads. This 
demonstration of RPV steam dryer structural integrity consists of three 
steps:
    (1) Predict the fluctuating pressure loads on the dryer,
    (2) Use these fluctuating pressure loads in a structural analysis 
to qualify the steam dryer design, and
    (3) Implement a startup test program for confirming the steam dryer 
design analysis results during the initial plant power ascension 
testing.
    The Plant Based Load Evaluation (PBLE) methodology is an analytical 
tool developed by GEH to predict fluctuating pressure loads on the 
steam dryer. Section 3.9.5 of the DCD references the GEH LTR NEDE-
33313P, ``ESBWR Steam Dryer Structural Evaluation,'' which references 
LTR NEDE-33312P, ``ESBWR Steam Dryer Acoustic Load Definition,'' which 
references the PBLE load definition method. The PBLE method is 
described in LTR NEDC-33408P, ``ESBWR Steam Dryer-Plant Base Load 
Evaluation Methodology.'' This LTR provides the theoretical basis for 
determining the fluctuating loads on the ESBWR steam dryer, describes 
the PBLE analytical model, determines the biases and uncertainties of 
the PBLE formulation, and describes the application of the PBLE method 
to the evaluation of the ESBWR steam dryer.
    The NRC's review of the PBLE methodology concludes that it is 
technically sound and provides a conservative analytical approach for 
definition of flow-induced acoustic pressure loading on the ESBWR steam 
dryer. The application of the PBLE load definition process together 
with the design criteria from the American Society of Mechanical 
Engineers (ASME) Code, Section III, Article NG-3000 in combination with 
the proposed start up test program provide assurance of the structural 
integrity of the steam dryer. Implementation of the analytical, design, 
and testing methodology for the ESBWR steam dryer demonstrate 
conformance with the general design criteria of 10 CFR part 50, 
Appendix A, GDCs 1, 2, and 4.

Aircraft Impact Assessment

    Under 10 CFR 50.150, which became effective on July 13, 2009, 
designers of new nuclear power reactors are required to perform an 
assessment of the effects on the designed facility of the impact of a 
large, commercial aircraft. An applicant for a new design certification 
rule is required to submit a description of the design features and 
functional capabilities identified as a result of the assessment (key 
design features) in its DCD together with a description of how the 
identified design features and functional capabilities show that the 
acceptance criteria in 10 CFR 50.150(a)(1) are met.
    To address the requirements of 10 CFR 50.150, GEH completed an 
assessment of the effects on the designed facility of the impact of a 
large, commercial aircraft. The GEH also added Appendix 19D to DCD Tier 
2 to describe the design features and functional capabilities of the 
ESBWR identified as a result of the assessment that ensure the reactor 
core remains cooled and the spent fuel pool integrity is maintained.
    The NRC finds that the applicant has performed an aircraft impact 
assessment using NRC-endorsed methodology that is reasonably formulated 
to identify design features and functional capabilities to show, with 
reduced use of operator action, that the acceptance criteria in 10 CFR 
50.150(a)(1) are met. The NRC finds that the applicant adequately 
describes the key design features and functional capabilities credited 
to meet 10 CFR 50.150, including descriptions of how the key design 
features and functional capabilities show that the acceptance criteria 
in 10 CFR 50.150(a)(1) are met. Therefore, the NRC finds that the 
applicant meets the applicable requirements of 10 CFR 50.150(b).

Code Case N-782

    Under 10 CFR 50.55a(a)(3), GEH requested NRC approval for the use 
of Code Case N-782 as a proposed alternative to the rules of Section 
III Subsection NCA-1140 regarding applied Code Editions and Addenda 
required by 10 CFR 50.55a(c), (d), and (e). Code Case N-782 provides 
that the Code Edition and Addenda endorsed in a certified design or 
licensed by the regulatory authority may be used for systems and 
components subject to ASME Code, Section III requirements. These 
alternative requirements are in lieu of the requirements that base the 
Edition and Addenda on the date of the COL or manufacturing license, or 
the application for a construction permit, standard design approval, or 
standard design certification. Reference to Code Case N-782 will be 
included in component and system design specifications and design 
reports to permit certification of these specifications and reports to 
the Code Edition and Addenda cited in the DCD. The NRC's bases for 
approving the use of Code Case N-782 as a proposed alternative to the 
requirements of Section III Subsection NCA-1140 under 10 CFR 
50.55a(a)(3) for the ESBWR are described in Section 5.2.1.1.3 of the 
FSER.

Exemptions

    The NRC is proposing to approve an exemption from 10 CFR 
50.34(f)(2)(iv) as it relates to the safety parameter display system. 
This provision requires an applicant to provide a plant safety 
parameter display console that will display to operators a minimum set 
of parameters defining the safety status of the plant, capable of 
displaying a full range of important plant parameters and data trends 
on demand and indicating when process limits are being approached or 
exceeded. The ESBWR design integrates the safety parameter display 
system into the design of the non-safety related distribution control 
and information system, rather than use a stand-alone console. The 
NRC's bases for providing the exemption are described in Section 
18.8.3.2 of the FSER.

V. Section-by-Section Analysis

    The following discussion sets forth the purpose and key aspects of 
each section and paragraph of the proposed ESBWR DCR. All section and 
paragraph references are to the provisions in the proposed Appendix E 
to 10 CFR part 52 unless otherwise noted. The NRC has modeled the ESBWR 
DCR on the existing DCRs, with certain modifications where necessary to 
account for differences in the ESBWR design documentation, design 
features, and EA (including severe accident mitigation design 
alternatives (SAMDAs)). As a result, the DCRs are standardized to the 
extent practical.

A. Introduction (Section I)

    The purpose of Section I of proposed Appendix E to 10 CFR part 52 
(this appendix) is to identify the standard plant design that would be 
approved by this DCR and the applicant for certification of the 
standard design. Identification of the design certification applicant 
is necessary to implement this appendix for two reasons. First, the 
implementation of 10 CFR 52.63(c) depends on whether an applicant for a 
COL contracts with the design certification applicant to provide the 
generic DCD and supporting design information. If the COL applicant 
does not use the design certification applicant to provide the design 
information and instead uses an alternate nuclear plant vendor, then 
the COL applicant must meet the requirements in 10 CFR 52.73. The COL 
applicant must demonstrate that the alternate supplier is qualified to 
provide the standard plant design information.

[[Page 16553]]

Second, paragraph X.A.1 would require the design certification 
applicant to maintain the generic DCD throughout the time this appendix 
may be referenced. Thus, it is necessary to identify the entity to 
which the requirement in paragraph X.A.1 applies.

B. Definitions (Section II)

    During development of the first two DCRs, the Commission decided 
that there would be both generic (master) DCDs maintained by the NRC 
and the design certification applicant, as well as individual plant-
specific DCDs maintained by each applicant and licensee that reference 
this appendix. This distinction is necessary in order to specify the 
relevant plant-specific requirements to applicants and licensees 
referencing the appendix. In order to facilitate the maintenance of the 
master DCDs, the NRC proposes that each application for a standard 
design certification be updated to include an electronic copy of the 
final version of the DCD. The final version would be required to 
incorporate all amendments to the DCD submitted since the original 
application as well as any changes directed by the NRC as a result of 
its review of the original DCD or as a result of public comments. This 
final version would become the master DCD incorporated by reference in 
the DCR. The master DCD would be revised as needed to include generic 
changes to the version of the DCD approved in this design certification 
rulemaking. These changes would occur as the result of generic 
rulemaking by the Commission, under the change criteria in Section 
VIII.
    The Commission would also require each applicant and licensee 
referencing this appendix to submit and maintain a plant-specific DCD 
as part of the COL Final Safety Analysis Report (FSAR). This plant-
specific DCD would include or incorporate by reference the information 
in the generic DCD. The plant-specific DCD would be updated as 
necessary to reflect the generic changes to the DCD that the Commission 
may adopt through rulemaking, plant-specific departures from the 
generic DCD that the Commission imposed on the licensee by order, and 
any plant-specific departures that the licensee chooses to make in 
accordance with the relevant processes in Section VIII. Thus, the 
plant-specific DCD would function like an updated FSAR because it would 
provide the most complete and accurate information on a plant's design 
basis for that part of the plant within the scope of this appendix. 
Therefore, this appendix would define both a generic DCD and a plant-
specific DCD.
    Also, the Commission decided to treat the TS in Chapter 16 of the 
generic DCD as a special category of information and to designate them 
as generic TS in order to facilitate the special treatment of this 
information under this appendix. A COL applicant must submit plant-
specific TS that consist of the generic TS, which may be modified under 
paragraph VIII.C, and the remaining plant-specific information needed 
to complete the TS. The FSAR that is required by 10 CFR 52.79 will 
consist of the plant-specific DCD, the site-specific portion of the 
FSAR, and the plant-specific TS.
    The terms Tier 1, Tier 2, Tier 2*, and COL action items (license 
information) are defined in this appendix because these concepts were 
not envisioned when 10 CFR part 52 was developed. The design 
certification applicants and the NRC used these terms in implementing 
the two-tiered rule structure that was proposed by representatives of 
the nuclear industry after issuance of 10 CFR part 52. Therefore, 
appropriate definitions for these additional terms are included in this 
appendix. The nuclear industry representatives requested a two-tiered 
structure for the DCRs to achieve issue preclusion for a greater amount 
of information than was originally planned for the DCRs, while 
retaining flexibility for design implementation. The Commission 
approved the use of a two-tiered rule structure in its SRM, dated 
February 14, 1991, on SECY-90-377, ``Requirements for Design 
Certification under 10 CFR Part 52,'' dated November 8, 1990. This 
document and others are available in the Regulatory History of Design 
Certification (see Section VII of this document).
    The Tier 1 portion of the design-related information contained in 
the DCD would be certified by this appendix and, therefore, subject to 
the special backfit provisions in paragraph VIII.A. An applicant who 
references this appendix would be required to include or incorporate by 
reference and comply with Tier 1, under paragraphs III.B and IV.A.1. 
This information consists of an introduction to Tier 1, the system 
based and non-system based design descriptions and corresponding ITAAC, 
significant interface requirements, and significant site parameters for 
the design (refer to Section C.I.1.8 of Regulatory Guide 1.206 for 
guidance on significant interface requirements and site parameters). 
The design descriptions, interface requirements, and site parameters in 
Tier 1 were derived from Tier 2, but may be more general than the Tier 
2 information. The NRC staff's evaluation of the Tier 1 information is 
provided in Section 14.3 of the FSER. Changes to or departures from the 
Tier 1 information must comply with Section VIII.A.
    The Tier 1 design descriptions serve as requirements for the 
lifetime of a facility license referencing the design certification. 
The inspection, test, analysis, and acceptance criterion/criteria 
(ITAAC) verify that the as-built facility conforms to the approved 
design and applicable regulations. Under 10 CFR 52.103(g), the 
Commission must find that the acceptance criteria in the ITAAC are met 
before authorizing operation. After the Commission has made the finding 
required by 10 CFR 52.103(g), the ITAAC do not constitute regulatory 
requirements for licensees or for renewal of the COL. However, 
subsequent modifications to the facility within the scope of the design 
certification must comply with the design descriptions in the plant-
specific DCD unless changes are made under the change process in 
Section VIII. The Tier 1 interface requirements are the most 
significant of the interface requirements for systems that are wholly 
or partially outside the scope of the standard design. Tier 1 interface 
requirements must be met by the site-specific design features of a 
facility that references this appendix. An application that references 
this appendix must demonstrate that the site characteristics at the 
proposed site fall within the site parameters (both Tier 1 and Tier 2) 
(refer to paragraph IV.D of this document).
    Tier 2 is the portion of the design-related information contained 
in the DCD that would be approved by this appendix but not certified. 
Tier 2 information would be subject to the backfit provisions in 
paragraph VIII.B. Tier 2 includes the information required by 10 CFR 
52.47(a) and 52.47(c) (with the exception of generic TS and conceptual 
design information) and the supporting information on inspections, 
tests, and analyses that will be performed to demonstrate that the 
acceptance criteria in the ITAAC have been met. As with Tier 1, 
paragraphs III.B and IV.A.1 would require an applicant who references 
this appendix to include or incorporate by reference Tier 2 and to 
comply with Tier 2, except for the COL action items, including the 
availability controls in Appendix 19ACM of the generic DCD. The 
definition of Tier 2 makes clear that Tier 2 information has been 
determined by the Commission, by virtue of its inclusion in this 
appendix and its designation as Tier 2 information, to be an approved 
sufficient method for meeting Tier 1 requirements. However,

[[Page 16554]]

there may be other acceptable ways of complying with Tier 1 
requirements. The appropriate criteria for departing from Tier 2 
information would be specified in paragraph VIII.B. Departures from 
Tier 2 information would not negate the requirement in paragraph III.B 
to incorporate by reference Tier 2 information.
    A definition of ``combined license action items'' (COL 
information), which is part of the Tier 2 information, would be added 
to clarify that COL applicants who reference this appendix are required 
to address COL action items in their license application. However, the 
COL action items are not the only acceptable set of information. An 
applicant may depart from or omit COL action items, provided that the 
departure or omission is identified and justified in the FSAR. After 
issuance of a construction permit or COL, these items would not be 
requirements for the licensee unless they are restated in the FSAR. For 
additional discussion, see Section IV.D of this document.
    The availability controls, which are set forth in Appendix 19ACM of 
the generic DCD, would be added to the information that is part of Tier 
2 to clarify that the availability controls are not operational 
requirements for the purposes of paragraph VIII.C. Rather, the 
availability controls are associated with specific design features. The 
availability controls may be changed if the associated design feature 
is changed under paragraph VIII.B. For additional discussion, see 
Section IV.C of this document.
    Certain Tier 2 information has been designated in the generic DCD 
with brackets and italicized text as ``Tier 2*'' information and, as 
discussed in greater detail in the section-by-section analysis for 
Section H, a plant-specific departure from Tier 2* information would 
require prior NRC approval. However, the Tier 2* designation expires 
for some of this information when the facility first achieves full 
power after the finding required by 10 CFR 52.103(g). The process for 
changing Tier 2* information and the time at which its status as Tier 
2* expires is set forth in paragraph VIII.B.6. Some Tier 2* 
requirements concerning special preoperational tests are designated to 
be performed only for the first plant or first three plants referencing 
the ESBWR DCR. The Tier 2* designation for these selected tests would 
expire after the first plant or first three plants complete the 
specified tests. However, a COL action item requires that subsequent 
plants also perform the tests or justify that the results of the first-
plant-only or first-three-plants-only tests are applicable to the 
subsequent plant.
    The regulations at 10 CFR 50.59 set forth thresholds for permitting 
changes to a plant as described in the FSAR without NRC approval. 
Inasmuch as 10 CFR 50.59 is the primary change mechanism for operating 
nuclear plants, the Commission believes that future plants referencing 
the ESBWR DCR should use thresholds as close to 10 CFR 50.59 as is 
practicable and appropriate for new reactors. Because of some 
differences in how the change control requirements are structured in 
the DCRs, certain definitions contained in 10 CFR 50.59 are not 
applicable to 10 CFR part 52 and are not being included in this 
proposed rule. The Commission is including a definition for a 
``departure from a method of evaluation'' (paragraph II.G), which is 
appropriate to include in this rulemaking so that the eight criteria in 
paragraph VIII.B.5.b will be implemented for new reactors as intended.

C. Scope and Contents (Section III)

    The purpose of Section III is to describe and define the scope and 
contents of this design certification and to set forth how 
documentation discrepancies or inconsistencies are to be resolved. 
Paragraph III.A is the required statement of the Office of the Federal 
Register (OFR) for approval of the incorporation by reference of Tier 
1, Tier 2, and the generic TS into this appendix. Paragraph III.B 
requires COL applicants and licensees to comply with the requirements 
of this appendix. The legal effect of incorporation by reference is 
that the incorporated material has the same legal status as if it were 
published in the Code of Federal Regulations. This material, like any 
other properly-issued regulation, has the force and effect of law. Tier 
1 and Tier 2 information, as well as the generic TS, have been combined 
into a single document called the generic DCD, in order to effectively 
control this information and facilitate its incorporation by reference 
into the rule. The generic DCD was prepared to meet the technical 
information contents of application requirements for design 
certifications under 10 CFR 52.47(a) and the requirements of the OFR 
for incorporation by reference under 1 CFR part 51. One of the 
requirements of the OFR for incorporation by reference is that the 
design certification applicant must make the generic DCD available upon 
request after the final rule becomes effective. Therefore, paragraph 
III.A would identify a GEH representative to be contacted in order to 
obtain a copy of the generic DCD.
    Paragraphs III.A and III.B would also identify the availability 
controls in Appendix 19ACM of the generic DCD as part of the Tier 2 
information. During its review of the ESBWR design, the NRC determined 
that residual uncertainties associated with passive safety system 
performance increased the importance of non-safety-related active 
systems in providing defense-in-depth functions that back-up the 
passive systems. As a result, GEH developed administrative controls to 
provide a high level of confidence that active systems having a 
significant safety role are available when challenged. The GEH named 
these additional controls ``availability controls.'' The Commission 
included this characterization in Section III to ensure that these 
availability controls would be binding on applicants and licensees that 
reference this appendix and would be enforceable by the NRC. The NRC's 
evaluation of the availability controls is provided in Chapter 22 of 
the FSER.
    The generic DCD (master copy) for this design certification is 
electronically accessible under ADAMS Accession No. ML103440266; at the 
OFR; and at http://www.regulations.gov by searching under Docket ID 
NRC-2010-0135. Copies of the generic DCD would also be available at the 
NRC's PDR. Questions concerning the accuracy of information in an 
application that references this appendix will be resolved by checking 
the master copy of the generic DCD in ADAMS. If the design 
certification applicant makes a generic change (rulemaking) to the DCD 
under 10 CFR 52.63 and the change process provided in Section VIII, 
then at the completion of the rulemaking the NRC would request approval 
of the Director, OFR, for the revised master DCD. The Commission would 
require that the design certification applicant maintain an up-to-date 
copy of the master DCD that includes any generic changes it has made 
under paragraph X.A.1 because it is likely that most applicants 
intending to reference the standard design would obtain the generic DCD 
from the design certification applicant. Plant-specific changes to and 
departures from the generic DCD would be maintained by the applicant or 
licensee that references this appendix in a plant-specific DCD under 
paragraph X.A.2.
    In addition to requiring compliance with this appendix, paragraph 
III.B would clarify that the conceptual design information and GEH's 
evaluation of SAMDAs are not considered to be part of this appendix. 
The conceptual design information is for those portions of the plant 
that are outside the scope of the standard design and are contained in

[[Page 16555]]

Tier 2 information. As provided by 10 CFR 52.47(a)(24), these 
conceptual designs are not part of this appendix and, therefore, are 
not applicable to an application that references this appendix. 
Therefore, the applicant would not be required to conform with the 
conceptual design information that was provided by the design 
certification applicant. The conceptual design information, which 
consists of site-specific design features, was required to facilitate 
the design certification review. Conceptual design information is 
neither Tier 1 nor Tier 2. Section 1.8.2 of Tier 2 identifies the 
location of the conceptual design information. The GEH's evaluation of 
various design alternatives to prevent and mitigate severe accidents 
does not constitute design requirements. The Commission's assessment of 
this information is discussed in Section X of this document.
    Paragraphs III.C and III.D would set forth the way potential 
conflicts are to be resolved. Paragraph III.C would establish the Tier 
1 description in the DCD as controlling in the event of an 
inconsistency between the Tier 1 and Tier 2 information in the DCD. 
Paragraph III.D would establish the generic DCD as the controlling 
document in the event of an inconsistency between the DCD and the FSER 
for the certified standard design.
    Paragraph III.E would clarify that design activities that are 
wholly outside the scope of this design certification may be performed 
using actual site characteristics, provided the design activities do 
not affect Tier 1 or Tier 2, or conflict with the interface 
requirements in the DCD. This provision would apply to site-specific 
portions of the plant, such as the administration building. Because 
this statement is not a definition, this provision has been located in 
Section III.

D. Additional Requirements and Restrictions (Section IV)

    Section IV would set forth additional requirements and restrictions 
imposed upon an applicant who references this appendix. Paragraph IV.A 
would set forth the information requirements for these applicants. This 
paragraph would distinguish between information and/or documents which 
must actually be included in the application or the DCD, versus those 
which may be incorporated by reference (i.e., referenced in the 
application as if the information or documents were included in the 
application). Any incorporation by reference in the application should 
be clear and should specify the title, date, edition, or version of a 
document, the page number(s), and table(s) containing the relevant 
information to be incorporated.
    Paragraph IV.A.1 would require an applicant who references this 
appendix to incorporate by reference this appendix in its application. 
The legal effect of such an incorporation by reference is that this 
appendix would be legally binding on the applicant or licensee. 
Paragraph IV.A.2.a would require that a plant-specific DCD be included 
in the initial application to ensure that the applicant commits to 
complying with the DCD. This paragraph would also require the plant-
specific DCD to either include or incorporate by reference the generic 
DCD information. Further, this paragraph would also require the plant-
specific DCD to use the same format as the generic DCD and reflect the 
applicant's proposed exemptions and departures from the generic DCD as 
of the time of submission of the application. The plant-specific DCD 
would be part of the plant's FSAR, along with information for the 
portions of the plant outside the scope of the referenced design. 
Paragraph IV.A.2.a would also require that the initial application 
include the reports on departures and exemptions as of the time of 
submission of the application.
    Paragraph IV.A.2.b would require that an application referencing 
this appendix include the reports required by paragraph X.B for 
exemptions and departures proposed by the applicant as of the date of 
submission of its application. Paragraph IV.A.2.c would require 
submission of plant-specific TS for the plant that consists of the 
generic TS from Chapter 16 of the DCD, with any changes made under 
paragraph VIII.C, and the TS for the site-specific portions of the 
plant that are either partially or wholly outside the scope of this 
design certification. The applicant must also provide the plant-
specific information designated in the generic TS, such as bracketed 
values (refer to guidance provided in Interim Staff Guidance DC/COL-
ISG-8, ``Necessary Content of Plant-Specific Technical 
Specifications'').
    Paragraph IV.A.2.d would require the applicant referencing this 
appendix to provide information demonstrating that the proposed site 
characteristics fall within the site parameters for this appendix and 
that the plant-specific interface requirements have been met as 
required by 10 CFR 52.79(d). If the proposed site has a characteristic 
that does not fall within one or more of the site parameters in the 
DCD, then the proposed site would be unacceptable for this design 
unless the applicant seeks an exemption under Section VIII and provides 
adequate justification for locating the certified design on the 
proposed site. Paragraph IV.A.2.e would require submission of 
information addressing COL action items, identified in the generic DCD 
as COL information in the application. The COL information identifies 
matters that need to be addressed by an applicant who references this 
appendix, as required by Subpart C of 10 CFR part 52. An applicant may 
differ from or omit these items, provided that the difference or 
omission is identified and justified in its application. Based on the 
applicant's difference or omission, the NRC may impose additional 
licensing requirement(s) on the COL applicant as appropriate. Paragraph 
IV.A.2.f would require that the application include the information 
specified by 10 CFR 52.47(a) that is not within the scope of this rule, 
such as generic issues that must be addressed or operational issues not 
addressed by a design certification, in whole or in part, by an 
applicant that references this appendix. Paragraph IV.A.3 would require 
the applicant to physically include, not simply reference, the SUNSI 
(including proprietary information) and SGI referenced in the DCD, or 
its equivalent, to ensure that the applicant has actual notice of these 
requirements.
    Paragraph IV.A.4 would indicate requirements that must be met in 
cases where the COL applicant is not using the entity that was the 
original applicant for the design certification (or amendment) to 
supply the design for the applicant's use. Proposed paragraph IV.A.4 
would require that a COL applicant referencing this appendix include, 
as part of its application, a demonstration that an entity other than 
GEH Nuclear Energy is qualified to supply the ESBWR certified design 
unless GEH Nuclear Energy supplies the design for the applicant's use. 
In cases where a COL applicant is not using GEH Nuclear Energy to 
supply the ESBWR certified design, the required information would be 
used to support any NRC finding under 10 CFR 52.73(a) that an entity 
other than the one originally sponsoring the design certification or 
design certification amendment is qualified to supply the certified 
design.
    Paragraph IV.B would reserve to the Commission the right to 
determine in what manner this appendix may be referenced by an 
applicant for a construction permit or operating license under 10 CFR 
part 50. This determination may occur in the context of a subsequent 
rulemaking modifying 10 CFR part 52 or this design

[[Page 16556]]

certification rule, or on a case-by-case basis in the context of a 
specific application for a 10 CFR part 50 construction permit or 
operating license. This provision is necessary because the previous 
DCRs were not implemented in the manner that was originally envisioned 
at the time that 10 CFR part 52 was promulgated. The Commission's 
concern is with the way ITAAC were developed and the lack of experience 
with design certifications in license proceedings. Therefore, it is 
appropriate that the Commission retain some discretion regarding the 
way this appendix could be referenced in a 10 CFR part 50 licensing 
proceeding.

E. Applicable Regulations (Section V)

    The purpose of Section V is to specify the regulations that would 
be applicable and in effect at the time this proposed design 
certification is approved (i.e., as of the date specified in paragraph 
V.A, which would be the date that this appendix is approved by the 
Commission and signed by the Secretary of the Commission). These 
regulations would consist of the technically relevant regulations 
identified in paragraph V.A, except for the regulations in paragraph 
V.B that would not be applicable to this certified design.
    In paragraph V.B, the Commission would identify the regulations 
that do not apply to the ESBWR design. The Commission has determined 
that the ESBWR design should be exempt from portions of 10 CFR 50.34 as 
described in the FSER (NUREG-XXXX) and/or summarized below:
(1) Paragraph (f)(2)(iv) of 10 CFR 50.34--Contents of Construction 
Permit and Operating License Applications: Technical Information
    This paragraph requires an applicant to provide a plant safety 
parameter display console that will display to operators a minimum set 
of parameters defining the safety status of the plant, capable of 
displaying a full range of important plant parameters and data trends 
on demand, and capable of indicating when process limits are being 
approached or exceeded. The ESBWR design integrates the safety 
parameter display system into the design of the non-safety related 
distribution control and information system, rather than use a stand-
alone console. The safety parameter display system is described in 
Section 7.1.5 of the DCD.
    The Commission has also determined that the ESBWR design is 
approved to use the following alternative. Under 10 CFR 50.55a(a)(3), 
GEH requested NRC approval for the use of Code Case N-782 as a proposed 
alternative to the rules of Section III, Subsection NCA-1140, regarding 
applied Code Editions and Addenda required by 10 CFR 50.55a(c), (d), 
and (e). Code Case N-782 provides that the Code Edition and Addenda 
endorsed in a certified design or licensed by the regulatory authority 
may be used for systems and components constructed to ASME Code, 
Section III requirements. These alternative requirements are in lieu of 
the requirements that base the Edition and Addenda on the construction 
permit date. Reference to Code Case N-782 will be included in component 
and system design specifications and design reports to permit 
certification of these specifications and reports to the Code Edition 
and Addenda cited in the DCD. The NRC's bases for approving the use of 
Code Case N-782 as a proposed alternative to the requirements of 
Section III Subsection NCA-1140 under 10 CFR 50.55a(a)(3) for ESBWR are 
described in Section 5.2.1.1.3 of the FSER.

F. Issue Resolution (Section VI)

    The purpose of Section VI is to identify the scope of issues that 
would be resolved by the Commission in this rulemaking and, therefore, 
are ``matters resolved'' within the meaning and intent of 10 CFR 
52.63(a)(5). The section is divided into five parts: paragraph A 
identifies the Commission's safety findings in adopting this appendix, 
paragraph B identifies the scope and nature of issues which are 
resolved by this rulemaking, paragraph C identifies issues which are 
not resolved by this rulemaking, paragraph D identifies the backfit 
restrictions applicable to the Commission with respect to this 
appendix, and paragraph E identifies the availability of secondary 
references.
    Paragraph VI.A would describe the nature of the Commission's 
findings in general terms and make the findings required by 10 CFR 
52.54 for the Commission's approval of this DCR. Furthermore, paragraph 
VI.A would explicitly state the Commission's determination that this 
design provides adequate protection of the public health and safety.
    Paragraph VI.B would set forth the scope of issues that may not be 
challenged as a matter of right in subsequent proceedings. The 
introductory phrase of paragraph VI.B clarifies that issue resolution 
as described in the remainder of the paragraph extends to the 
delineated NRC proceedings referencing this appendix. The remainder of 
paragraph VI.B describes the categories of information for which there 
is issue resolution. Specifically, paragraph VI.B.1 would provide that 
all nuclear safety issues arising from the Atomic Energy Act of 1954, 
as amended, that are associated with the information in the NRC staff's 
FSER (NUREG-XXXX), the Tier 1 and Tier 2 information (including the 
availability controls in Appendix 19ACM of the generic DCD), and the 
rulemaking record for this appendix are resolved within the meaning of 
10 CFR 52.63(a)(5). These resolved issues include the information 
referenced in the DCD that are requirements (i.e., ``secondary 
references''), as well as all issues arising from proprietary 
information and SGI that are intended to be requirements, but does not 
include the HFE processes for procedure development and training 
program development identified in Sections 18.9 and 18.10 of the 
generic DCD.
    Paragraph VI.B.2 would provide for issue preclusion of SUNSI 
(including proprietary information) and SGI. Paragraphs VI.B.3, VI.B.4, 
VI.B.5, and VI.B.6 would clarify that approved changes to and 
departures from the DCD, which are accomplished in compliance with the 
relevant procedures and criteria in Section VIII, continue to be 
matters resolved in connection with this rulemaking. Paragraphs VI.B.4, 
VI.B.5, and VI.B.6, which would characterize the scope of issue 
resolution in three situations, use the phrase ``but only for that 
plant.'' Paragraph VI.B.4 would describe 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 would describe how issues are resolved when a plant 
referencing the DC rule obtains a license amendment for a departure 
from Tier 2 information. Paragraph VI.B.6 would describe how issues are 
resolved when the applicant or licensee departs from the Tier 2 
information on the basis of paragraph VIII.B.5, which would waive the 
requirement for NRC approval. In all three situations, after a matter 
(e.g., an exemption in the case of paragraph VI.B.4) is addressed for a 
specific plant referencing a design certification rule, the adequacy of 
that matter for that plant is resolved and would constitute part of the 
licensing basis for that plant. Therefore, that matter would not 
ordinarily be subject to challenge in any subsequent proceeding or 
action for that plant (e.g., an enforcement action) listed in the 
introductory portion of paragraph IV.B. By contrast, there would be no 
legally binding issue resolution on that subject matter for any other 
plant, or in

[[Page 16557]]

a subsequent rulemaking amending the applicable design certification 
rule. However, the NRC's consideration of the safety, regulatory or 
policy issues necessary to the determination of the exemption or 
license amendment may, in appropriate circumstances, be relied upon as 
part of the basis for NRC action in other licensing proceedings or 
rulemaking.
    Paragraph VI.B.7 would provide that, for those plants located on 
sites whose site characteristics fall within the site parameters 
assumed in the GEH evaluation of SAMDAs, all issues with respect to 
SAMDAs arising under the National Environmental Policy Act of 1969, as 
amended (NEPA), associated with the information in the EA for this 
design and the information regarding SAMDAs in NEDO-33306, Revision 4, 
``ESBWR Severe Accident Mitigation Design Alternatives'' are also 
resolved within the meaning and intent of 10 CFR 52.63(a)(5). If a 
deviation from a site parameter is granted, the deviation applicant has 
the initial burden of demonstrating that the original SAMDA analysis 
still applies to the actual site characteristics; but, if the deviation 
is approved, requests for litigation at the COL stage must meet the 
requirements of 10 CFR 2.309 and present sufficient information to 
create a genuine controversy in order to obtain a hearing on the site 
parameter deviation.
    Paragraph VI.C would reserve the right of the Commission to impose 
operational requirements on applicants that reference this appendix. 
This provision would reflect the fact that only some operational 
requirements, including portions of the generic TS in Chapter 16 of the 
DCD, and no operational programs, such as operational QA, were 
completely or comprehensively reviewed by the NRC in this design 
certification rulemaking proceeding. Therefore, the special backfit and 
finality provisions of 10 CFR 52.63 would apply only to those 
operational requirements that either the NRC completely reviewed and 
approved, or formed the basis for an NRC safety finding of the adequacy 
of the ESBWR, as documented in the NRC's safety evaluation report for 
the ESBWR. This is consistent with the currently approved design 
certifications in 10 CFR part 52, Appendices A through D. Although 
information on operational matters is included in the DCDs of each of 
these currently approved designs, for the most part these design 
certifications do not provide approval for operational information, and 
none provide approval for operational ``programs'' (e.g., emergency 
preparedness programs, operational quality assurance programs). Most 
operational information in the DCD simply serves as ``contextual 
information'' (i.e., information necessary to understand the design of 
certain SSCs and how they would be used in the overall context of the 
facility). The NRC did not use contextual information to support the 
NRC's safety conclusions, and such information does not constitute the 
underlying safety bases for the adequacy of those SSCs. Thus, 
contextual operational information on any particular topic would not 
constitute one of the ``matters resolved'' under paragraph VI.B.
    The NRC notes that operational requirements may be imposed on 
licensees referencing this design certification through the inclusion 
of license conditions in the license, or inclusion of a description of 
the operational requirement in the plant-specific FSAR.\2\ The NRC's 
choice of the regulatory vehicle for imposing the operational 
requirements will depend upon, among other things: (1) Whether the 
development and/or implementation of these requirements must occur 
prior to either the issuance of the COL or the Commission finding under 
10 CFR 52.103(g), and (2) the nature of the change controls which the 
NRC believes are appropriate given the regulatory, safety, and security 
significance of each operational requirement.
---------------------------------------------------------------------------

    \2\ Certain activities, ordinarily conducted following fuel load 
and therefore considered ``operational requirements'' but which may 
be relied upon to support a Commission finding under 10 CFR 
52.103(g), may themselves be the subject of ITAAC to ensure their 
implementation prior to the 10 CFR 52.103(g) finding.
---------------------------------------------------------------------------

    Paragraph VI.C would allow the NRC to impose future operational 
requirements (distinct from design matters) on applicants who reference 
this design certification. Also, license conditions for portions of the 
plant within the scope of this design certification (e.g., start-up and 
power ascension testing), are not restricted by 10 CFR 52.63. The 
requirement to perform these testing programs is contained in Tier 1 
information. However, ITAAC cannot be specified for these subjects 
because the matters to be addressed in these license conditions cannot 
be verified prior to fuel load and operation, when the ITAAC are 
satisfied. Therefore, another regulatory vehicle is necessary to ensure 
that licensees comply with the matters contained in the license 
conditions. License conditions for these areas cannot be developed now 
because this requires the type of detailed design information that will 
be developed during a COL review. In the absence of detailed design 
information to evaluate the need for and develop specific post-fuel 
load verifications for these matters, the Commission is reserving in 
this rule the right to impose, at the time of COL issuance, license 
conditions addressing post-fuel load verification activities for 
portions of the plant within the scope of this design certification.
    Paragraph VI.D would reiterate the restrictions (contained in 
Section VIII) placed upon the Commission when ordering generic or 
plant-specific modifications, changes or additions to structures, 
systems, or components, design features, design criteria, and ITAAC 
(paragraph VI.D.3 would address ITAAC) within the scope of the 
certified design.
    Paragraph VI.E would provide that the NRC will specify at an 
appropriate time the procedures for interested persons to obtain access 
to proprietary information, SUNSI, and SGI information for the ESBWR 
design certification rule. Access to such information would be for the 
sole purpose of requesting or participating in certain specified 
hearings, such as (1) the hearing required by 10 CFR 52.85 where the 
underlying application references this appendix; (2) any hearing 
provided under 10 CFR 52.103 where the underlying COL references this 
appendix; and (3) any other hearing relating to this appendix in which 
interested persons have the right to request an adjudicatory hearing.
    For proceedings where the notice of hearing was published before 
[EFFECTIVE DATE OF FINAL RULE], the Commission's order governing access 
to SUNSI and SGI shall be used to govern access to proprietary 
information, SUNSI, and SGI within the scope of the rulemaking. For 
proceedings in which the notice of hearing or opportunity for hearing 
is published after [EFFECTIVE DATE OF FINAL RULE], paragraph VI.E 
applies and governs access to proprietary information, SUNSI, and SGI. 
For these proceedings, as stated in paragraph VI.E, the NRC will 
specify the access procedures at an appropriate time.
    For both a hearing required by 10 CFR 52.85 where the underlying 
application references this appendix, and in any hearing on ITAAC 
completion under 10 CFR 52.103, the NRC expects to follow its current 
practice of establishing the procedures by order at the time that the 
notice of hearing is published in the Federal Register. See, for 
example, Florida Power and Light Co., Combined License Application for 
the Turkey Point Units 6 & 7, Notice of Hearing, Opportunity To 
Petition for Leave To Intervene and Associated Order

[[Page 16558]]

Imposing Procedures for Access to SUNSI and Safeguards Information for 
Contention Preparation (75 FR 34777; June 18, 2010); Notice of Receipt 
of Application for License; Notice of Consideration of Issuance of 
License; Notice of Hearing and Commission Order and Order Imposing 
Procedures for Access to SUNSI and Safeguards Information for 
Contention Preparation; In the Matter of AREVA Enrichment Services, LLC 
(Eagle Rock Enrichment Facility) (74 FR 38052; July 30, 2009).

G. Duration of This Appendix (Section VII)

    The purpose of Section VII would be, in part, to specify the period 
during which this design certification may be referenced by an 
applicant for a COL, under 10 CFR 52.55. This section would also state 
that the design certification would remain valid for an applicant or 
licensee that references the design certification until the application 
is withdrawn or the license expires. Therefore, if an application 
references this design certification during the 15-year period, then 
the design certification would be effective until the application is 
withdrawn or the license issued on that application expires. Also, the 
design certification would be effective for the referencing licensee if 
the license is renewed. The Commission intends for this appendix to 
remain valid for the life of the plant that references the design 
certification to achieve the benefits of standardization and licensing 
stability. This means that changes to, or plant-specific departures 
from, information in the plant-specific DCD must be made under the 
change processes in Section VIII for the life of the plant.

H. Processes for Changes and Departures (Section VIII)

    The purpose of Section VIII would be to set forth the processes for 
generic changes to, or plant-specific departures (including exemptions) 
from, the DCD. The Commission adopted this restrictive change process 
in order to achieve a more stable licensing process for applicants and 
licensees that reference this DCR. Section VIII is divided into three 
paragraphs, which correspond to Tier 1, Tier 2, and operational 
requirements. The language of Section VIII distinguishes between 
generic changes to the DCD versus plant-specific departures from the 
DCD. Generic changes must be accomplished by rulemaking because the 
intended subject of the change is this DCR itself, as is contemplated 
by 10 CFR 52.63(a)(1). Consistent with 10 CFR 52.63(a)(3), any generic 
rulemaking changes are applicable to all plants, absent circumstances 
which render the change [``modification'' in the language of 10 CFR 
52.63(a)(3)] ``technically irrelevant.'' By contrast, plant-specific 
departures could be either a Commission-issued order to one or more 
applicants or licensees; or an applicant or licensee-initiated 
departure applicable only to that applicant's or licensee's plant(s), 
similar to a 10 CFR 50.59 departure or an exemption. Because these 
plant-specific departures will result in a DCD that is unique for that 
plant, Section X would require an applicant or licensee to maintain a 
plant-specific DCD. For purposes of brevity, this discussion refers to 
both generic changes and plant-specific departures as ``change 
processes.''
    Section VIII refers to an exemption from one or more requirements 
of this appendix and the criteria for granting an exemption. The 
Commission cautions that when the exemption involves an underlying 
substantive requirement (applicable regulation), then the applicant or 
licensee requesting the exemption must also show that an exemption from 
the underlying applicable requirement meets the criteria of 10 CFR 
52.7.
Tier 1 Information
    The change processes for Tier 1 information would be covered in 
paragraph VIII.A. Generic changes to Tier 1 are accomplished by 
rulemakings that amend the generic DCD and are governed by the 
standards in 10 CFR 52.63(a)(1) and 10 CFR 52.63(a)(2). No matter who 
proposes it, a generic change under 10 CFR 52.63(a)(1) will not be made 
to a certified design while it is in effect unless the change: (1) Is 
necessary for compliance with Commission regulations applicable and in 
effect at the time the certification was issued; (2) is necessary to 
provide adequate protection of the public health and safety or common 
defense and security; (3) reduces unnecessary regulatory burden and 
maintains protection to public health and safety and common defense and 
security; (4) provides the detailed design information necessary to 
resolve selected design acceptance criteria; (5) corrects material 
errors in the certification information; (6) substantially increases 
overall safety, reliability, or security of a facility and the costs of 
the change are justified; or (7) contributes to increased 
standardization of the certification information. The rulemakings must 
provide for notice and opportunity for public comment on the proposed 
change, as required by 10 CFR 52.63(a)(2). The Commission will give 
consideration to whether the benefits justify the costs for plants that 
are already licensed or for which an application for a permit or 
license is under consideration.
    Departures from Tier 1 may occur in two ways: (1) the Commission 
may order a licensee to depart from Tier 1, as provided in paragraph 
VIII.A.3; or (2) an applicant or licensee may request an exemption from 
Tier 1, as provided in paragraph VIII.A.4. If the Commission seeks to 
order a licensee to depart from Tier 1, paragraph VIII.A.3 would 
require that the Commission find both that the departure is necessary 
for adequate protection or for compliance and that special 
circumstances are present. Paragraph VIII.A.4 would provide that 
exemptions from Tier 1 requested by an applicant or licensee are 
governed by the requirements of 10 CFR 52.63(b)(1) and 52.98(f), which 
provide an opportunity for a hearing. In addition, the Commission would 
not grant requests for exemptions that may result in a significant 
decrease in the level of safety otherwise provided by the design.
Tier 2 Information
    The change processes for the three different categories of Tier 2 
information, namely, Tier 2, Tier 2*, and Tier 2* with a time of 
expiration, would be set forth in paragraph VIII.B. The change process 
for Tier 2 has the same elements as the Tier 1 change process, but some 
of the standards for plant-specific orders and exemptions would be 
different.
    The process for generic Tier 2 changes (including changes to Tier 
2* and Tier 2* with a time of expiration) tracks the process for 
generic Tier 1 changes. As set forth in paragraph VIII.B.1, generic 
Tier 2 changes would be accomplished by rulemaking amending the generic 
DCD and would be governed by the standards in 10 CFR 52.63(a)(1). No 
matter who proposes it, a generic change under 10 CFR 52 52.63(a)(1) 
will not be made to a certified design while it is in effect unless the 
change: (1) Is necessary for compliance with Commission regulations 
applicable and in effect at the time the certification was issued; (2) 
is necessary to provide adequate protection of the public health and 
safety or common defense and security; (3) reduces unnecessary 
regulatory burden and maintains protection to public health and safety 
and common defense and security; (4) provides the detailed design 
information necessary to resolve selected design acceptance criteria; 
(5) corrects material errors in the certification information; (6) 
substantially increases overall safety,

[[Page 16559]]

reliability, or security of a facility and the costs of the change are 
justified; or (7) contributes to increased standardization of the 
certification information. If a generic change is made to Tier 2* 
information, then the category and expiration, if necessary, of the new 
information would also be determined in the rulemaking and the 
appropriate change process for that new information would apply.
    Departures from Tier 2 would occur in five ways: (1) The Commission 
may order a plant-specific departure, as set forth in paragraph 
VIII.B.3; (2) an applicant or licensee may request an exemption from a 
Tier 2 requirement as set forth in paragraph VIII.B.4; (3) a licensee 
may make a departure without prior NRC approval under paragraph 
VIII.B.5; (4) the licensee may request NRC approval for proposed 
departures which do not meet the requirements in paragraph VIII.B.5 as 
provided in paragraph VIII.B.5.d; and (5) the licensee may request NRC 
approval for a departure from Tier 2* information under paragraph 
VIII.B.6.
    Similar to Commission-ordered Tier 1 departures and generic Tier 2 
changes, Commission-ordered Tier 2 departures could not be imposed 
except when necessary either to bring the certification into compliance 
with the Commission's regulations applicable and in effect at the time 
of approval of the design certification or to ensure adequate 
protection of the public health and safety or common defense and 
security, as set forth in paragraph VIII.B.3. However, the special 
circumstances for the Commission-ordered Tier 2 departures would not 
have to outweigh any decrease in safety that may result from the 
reduction in standardization caused by the plant-specific order, as 
required by 10 CFR 52.63(a)(4). The Commission determined that it was 
not necessary to impose an additional limitation similar to that 
imposed on Tier 1 departures by 10 CFR 52.63(a)(4) and (b)(1). This 
type of additional limitation for standardization would unnecessarily 
restrict the flexibility of applicants and licensees with respect to 
Tier 2 information.
    An applicant or licensee would be permitted to request an exemption 
from Tier 2 information as set forth in paragraph VIII.B.4. The 
applicant or licensee would have to demonstrate that the exemption 
complies with one of the special circumstances in 10 CFR 50.12(a). In 
addition, the Commission would not grant requests for exemptions that 
may result in a significant decrease in the level of safety otherwise 
provided by the design. However, the special circumstances for the 
exemption do not have to outweigh any decrease in safety that may 
result from the reduction in standardization caused by the exemption. 
If the exemption is requested by an applicant for a license, the 
exemption would be subject to litigation in the same manner as other 
issues in the license hearing, consistent with 10 CFR 52.63(b)(1). If 
the exemption is requested by a licensee, then the exemption would be 
subject to litigation in the same manner as a license amendment.
    Paragraph VIII.B.5 would allow an applicant or licensee to depart 
from Tier 2 information, without prior NRC approval, if the proposed 
departure does not involve a change to, or departure from, Tier 1 or 
Tier 2* information, TS, or does not require a license amendment under 
paragraphs VIII.B.5.b or VIII.B.5.c. The TS referred to in VIII.B.5.a 
of this paragraph are the TS in Chapter 16 of the generic DCD, 
including bases, for departures made prior to issuance of the COL. 
After issuance of the COL, the plant-specific TS would be controlling 
under paragraph VIII.B.5. The bases for the plant-specific TS would be 
controlled by the bases control program, which is specified in the 
plant-specific TS administrative controls section. The requirement for 
a license amendment in paragraph VIII.B.5.b would be similar to the 
requirement in 10 CFR 50.59 and apply to all information in Tier 2 
except for the information that resolves the severe accident issues.
    The Commission believes that the resolution of ex-vessel severe 
accident design features should be preserved and maintained in the same 
fashion as all other safety issues that were resolved during the design 
certification review (refer to SRM on SECY-90-377, ``Requirements for 
Design Certification Under 10 CFR Part 52,'' dated February 15, 1991, 
ADAMS Accession No. ML003707892). However, because of the increased 
uncertainty in ex-vessel severe accident issue resolutions, the 
Commission has proposed separate criteria in paragraph VIII.B.5.c for 
determining if a departure from information that resolves ex-vessel 
severe accident design features would require a license amendment. For 
purposes of applying the special criteria in paragraph VIII.B.5.c, ex-
vessel severe accident resolutions would be limited to design features 
where the intended function of the design feature is relied upon to 
resolve postulated accidents when the reactor core has melted and 
exited the reactor vessel, and the containment is being challenged. 
These design features are identified in Sections 19.2.3, 19.3.2, 
19.3.3, 19.3.4, and Appendices 19A and 19B of the DCD, with other 
issues, and are described in other sections of the DCD. Therefore, the 
location of design information in the DCD is not important to the 
application of this special procedure for ex-vessel severe accident 
design features. However, the special procedure in paragraph VIII.B.5.c 
would not apply to design features that resolve so-called ``beyond 
design-basis accidents'' or other low-probability events. The important 
aspect of this special procedure is that it would be limited to ex-
vessel severe accident design features, as defined above. Some design 
features may have intended functions to meet ``design basis'' 
requirements and to resolve ``severe accidents.'' If these design 
features are reviewed under paragraph VIII.B.5, then the appropriate 
criteria from either paragraphs VIII.B.5.b or VIII.B.5.c would be 
selected depending upon the function being changed.
    An applicant or licensee that plans to depart from Tier 2 
information, under paragraph VIII.B.5, would be required to prepare an 
evaluation which provides the bases for the determination that the 
proposed change does not require a license amendment or involve a 
change to Tier 1 or Tier 2* information, or a change to the TS, as 
explained above. In order to achieve the Commission's goals for design 
certification, the evaluation would need to consider all of the matters 
that were resolved in the DCD, such as generic issue resolutions that 
are relevant to the proposed departure. The benefits of the early 
resolution of safety issues would be lost if departures from the DCD 
were made that violated these resolutions without appropriate review.
    The evaluation of the relevant matters would need to consider the 
proposed departure over the full range of power operation from startup 
to shutdown, as it relates to anticipated operational occurrences, 
transients, design-basis accidents, and severe accidents. The 
evaluation would also have to include a review of all relevant 
secondary references from the DCD because Tier 2 information, which is 
intended to be treated as a requirement, would be contained in the 
secondary references. The evaluation should consider Tables 14.3-1a 
through 14.3-1c and 19.2-3 of the generic DCD to ensure that the 
proposed change does not impact Tier 1 information. These tables 
contain cross-references from the safety analyses and probabilistic 
risk assessment in Tier 2 to the important parameters that were 
included in Tier 1.

[[Page 16560]]

    Paragraph VIII.B.5.d addresses information described in the DCD to 
address aircraft impacts, in accordance with 10 CFR 52.47(a)(28). Under 
10 CFR 52.47(a)(28), applicants are required to include the information 
required by 10 CFR 50.150(b) in their DCD. Under 10 CFR 50.150(b), 
applications for standard design certifications are required to 
include:
    1. A description of the design features and functional capabilities 
identified as a result of the aircraft impact assessment required by 10 
CFR 50.150(a)(1); and
    2. A description of how such design features and functional 
capabilities meet the assessment requirements in 10 CFR 50.150(a)(1).
    An applicant or licensee who changes this information is required 
to consider the effect of the changed design feature or functional 
capability on the original aircraft impact assessment required by 10 
CFR 50.150(a). The applicant or licensee is also required to describe 
in the plant-specific DCD how the modified design features and 
functional capabilities continue to meet the assessment requirements in 
10 CFR 50.150(a)(1). Submittal of this updated information is governed 
by the reporting requirements in Section X.B.
    In an adjudicatory proceeding (e.g., for issuance of a COL) a 
person who believes that an applicant or licensee has not complied with 
paragraph VIII.B.5 when departing from Tier 2 information, would be 
permitted to petition to admit such a contention into the proceeding 
under paragraph VIII.B.5.f. This provision has been proposed because an 
incorrect departure from the requirements of this appendix essentially 
would place the departure outside of the scope of the Commission's 
safety finding in the design certification rulemaking. Therefore, it 
follows that properly founded contentions alleging such incorrectly 
implemented departures cannot be considered ``resolved'' by this 
rulemaking. As set forth in paragraph VIII.B.5.f, the petition would 
have to comply with the requirements of 10 CFR 2.309 and show that the 
departure does not comply with paragraph VIII.B.5. Other persons would 
be allowed to file a response to the petition under 10 CFR 2.309. If on 
the basis of the petition and any responses, the presiding officer in 
the proceeding determines that the required showing has been made, the 
matter would be certified to the Commission for its final 
determination. In the absence of a proceeding, petitions alleging 
nonconformance with paragraph VIII.B.5 requirements applicable to Tier 
2 departures would be treated as petitions for enforcement action under 
10 CFR 2.206.
    Paragraph VIII.B.6 would provide a process for departing from Tier 
2* information. The creation of and restrictions on changing Tier 2* 
information resulted from the development of the Tier 1 information for 
the ABWR design certification (Appendix A to 10 CFR part 52) and the 
System 80+ design certification (Appendix B to 10 CFR part 52). During 
this development process, these applicants requested that the amount of 
information in Tier 1 be minimized to provide additional flexibility 
for an applicant or licensee who references these appendices. Also, 
many codes, standards, and design processes, which would not be 
specified in Tier 1 that are acceptable for meeting ITAAC, were 
specified in Tier 2. The result of these departures would be that 
certain significant information only exists in Tier 2 and the 
Commission would not want this significant information to be changed 
without prior NRC approval. This Tier 2* information would be 
identified in the generic DCD with italicized text and brackets (See 
Table 1D-1 in Appendix 1D of the ESBWR DCD).
    Although the Tier 2* designation was originally intended to last 
for the lifetime of the facility, like Tier 1 information, the NRC 
determined that some of the Tier 2* information could expire when the 
plant first achieves full (100 percent) power, after the finding 
required by 10 CFR 52.103(g), while other Tier 2* information must 
remain in effect throughout the life of the facility. The factors 
determining whether Tier 2* information could expire after full power 
is first achieved (first full power) were whether the Tier 1 
information would govern these areas after first full power and the 
NRC's determination that prior approval was required before 
implementation of the change due to the significance of the 
information. Therefore, certain Tier 2* information listed in paragraph 
VIII.B.6.c would cease to retain its Tier 2* designation after full-
power operation is first achieved following the Commission finding 
under 10 CFR 52.103(g). Thereafter, that information would be deemed to 
be Tier 2 information that would be subject to the departure 
requirements in paragraph VIII.B.5. By contrast, the Tier 2* 
information identified in paragraph VIII.B.6.b would retain its Tier 2* 
designation throughout the duration of the license, including any 
period of license renewal.
    Certain preoperational tests in paragraph VIII.B.6.c would be 
designated to be performed only for the first plant that references 
this appendix. The GEH's basis for performing these ``first-plant-
only'' preoperational tests is provided in Section 14.2.8 of the DCD. 
The NRC found GEH's basis for performing these tests and its 
justification for only performing the tests on the first plant 
acceptable. The NRC's decision was based on the need to verify that 
plant-specific manufacturing and/or construction variations do not 
adversely impact the predicted performance of certain passive safety 
systems, while recognizing that these special tests would result in 
significant thermal transients being applied to critical plant 
components. The NRC believes that the range of manufacturing or 
construction variations that could adversely affect the relevant 
passive safety systems would be adequately disclosed after performing 
the designated tests on the first plant. The Tier 2* designation for 
these tests would expire after the first completes these tests, as 
indicated in paragraph VIII.B.6.c.
    If Tier 2* information is changed in a generic rulemaking, the 
designation of the new information (Tier 1, 2*, or 2) would also be 
determined in the rulemaking and the appropriate process for future 
changes would apply. If a plant-specific departure is made from Tier 2* 
information, then the new designation would apply only to that plant. 
If an applicant who references this design certification makes a 
departure from Tier 2* information, the new information would be 
subject to litigation in the same manner as other plant-specific issues 
in the licensing hearing. If a licensee makes a departure from Tier 2* 
information, it would be treated as a license amendment under 10 CFR 
50.90 and the finality would be determined under paragraph VI.B.5. Any 
requests for departures from Tier 2* information that affects Tier 1 
would also have to comply with the requirements in paragraph VIII.A.
Operational Requirements
    The change process for TS and other operational requirements in the 
DCD would be set forth in paragraph VIII.C. This change process has 
elements similar to the Tier 1 and Tier 2 change processes in 
paragraphs VIII.A and VIII.B, but with significantly different change 
standards. Because of the different finality status for TS and other 
operational requirements (refer to paragraph V.F of this document), the 
Commission designated a special category of information, consisting of 
the TS and other operational requirements, with its own change

[[Page 16561]]

process in proposed paragraph VIII.C. The key to using the change 
processes proposed in Section VIII is to determine if the proposed 
change or departure would require a change to a design feature 
described in the generic DCD. If a design change is required, then the 
appropriate change process in paragraph VIII.A or VIII.B would apply. 
However, if a proposed change to the TS or other operational 
requirements does not require a change to a design feature in the 
generic DCD, then paragraph VIII.C would apply. The language in 
paragraph VIII.C would also distinguish between generic (Chapter 16 of 
the DCD) and plant-specific TS to account for the different treatment 
and finality accorded TS before and after a license is issued.
    The process in paragraph VIII.C.1 for making generic changes to the 
generic TS in Chapter 16 of the DCD or other operational requirements 
in the generic DCD would be accomplished by rulemaking and governed by 
the backfit standards in 10 CFR 50.109. The determination of whether 
the generic TS and other operational requirements were completely 
reviewed and approved in the design certification rulemaking would be 
based upon the extent to which the NRC reached a safety conclusion in 
the FSER on this matter. If it cannot be determined, in the absence of 
a specific statement, that the TS or operational requirement was 
comprehensively reviewed and finalized in the design certification 
rulemaking, then there would be no backfit restriction under 10 CFR 
50.109 because no prior position, consistent with paragraph VI.B, was 
taken on this safety matter. Generic changes made under paragraph 
VIII.C.1 would be applicable to all applicants or licensees (refer to 
paragraph VIII.C.2), unless the change is irrelevant because of a 
plant-specific departure.
    Some generic TS and availability controls contain values in 
brackets [ ]. The brackets are placeholders indicating that the NRC's 
review is not complete, and represent a requirement that the applicant 
for a COL referencing the ESBWR DCR must replace the values in brackets 
with final plant-specific values (refer to guidance provided in Interim 
Staff Guidance DC/COL-ISG-8, ``Necessary Content of Plant-Specific 
Technical Specifications''). The values in brackets are neither part of 
the design certification rule nor are they binding. Therefore, the 
replacement of bracketed values with final plant-specific values does 
not require an exemption from the generic TS or availability controls.
    Plant-specific departures may occur by either a Commission order 
under paragraph VIII.C.3 or an applicant's exemption request under 
paragraph VIII.C.4. The basis for determining if the TS or operational 
requirement was completely reviewed and approved for these processes 
would be the same as for paragraph VIII.C.1 above. If the TS or 
operational requirement is comprehensively reviewed and finalized in 
the design certification rulemaking, then the Commission must 
demonstrate that special circumstances are present before ordering a 
plant-specific departure. If not, there would be no restriction on 
plant-specific changes to the TS or operational requirements, prior to 
the issuance of a license, provided a design change is not required. 
Although the generic TS were reviewed and approved by the NRC staff in 
support of the DC review, the Commission intends to consider the 
lessons learned from subsequent operating experience during its 
licensing review of the plant-specific TS. The process for petitioning 
to intervene on a TS or operational requirement contained in paragraph 
VIII.C.5 would be similar to other issues in a licensing hearing, 
except that the petitioner must also demonstrate why special 
circumstances are present pursuant to 10 CFR 2.335.
    Finally, the generic TS would have no further effect on the plant-
specific TS after the issuance of a license that references this 
appendix. The bases for the generic TS would be controlled by the 
change process in paragraph VIII.C. After a license is issued, the 
bases would be controlled by the bases change provision set forth in 
the administrative controls section of the plant-specific TS.

I. Inspections, Tests, Analyses, and Acceptance Criteria (ITAAC) 
(Section IX)

    This section is reserved for future use.

J. Records and Reporting (Section X)

    The purpose of Section X would be to set forth the requirements 
that would apply to maintaining records of changes to and departures 
from the generic DCD, which would be reflected in the plant-specific 
DCD. Section X would also set forth the requirements for submitting 
reports (including updates to the plant-specific DCD) to the NRC. This 
section of the appendix would be similar to the requirements for 
records and reports in 10 CFR part 50, except for minor differences in 
information collection and reporting requirements.
    Paragraph X.A.1 would require that a generic DCD and the SUNSI 
(including proprietary information) and SGI referenced in the generic 
DCD be maintained by the applicant for this rule. The generic DCD 
concept was developed, in part, to meet the OFR requirements for 
incorporation by reference, including public availability of documents 
incorporated by reference. However, the SUNSI (including proprietary 
information) and SGI could not be included in the generic DCD because 
they are not publicly available. Nonetheless, the SUNSI (including 
proprietary information) and SGI was reviewed by the NRC and, as stated 
in paragraph VI.B.2, the NRC would consider the information to be 
resolved within the meaning of 10 CFR 52.63(a)(5). Because this 
information is not in the generic DCD, this information, or its 
equivalent, is required to be provided by an applicant for a license 
referencing this design certification rule. Paragraph X.A.1 would 
require the design certification applicant to maintain the SUNSI 
(including proprietary information) and SGI, which it developed and 
used to support its design certification application. This would ensure 
that the referencing applicant has direct access to this information 
from the design certification applicant, if it has contracted with the 
applicant to provide the proprietary information and SGI to support its 
license application. The NRC may also inspect this information if it 
was not submitted to the NRC (e.g., the aircraft impact assessment 
required by 10 CFR 50.150). Only the generic DCD would be identified 
and incorporated by reference into this rule. The generic DCD and the 
NRC-approved version of the SUNSI (including proprietary information) 
and SGI would be maintained for the period of time that this appendix 
may be referenced.
    Paragraphs X.A.2 and X.A.3 would place recordkeeping requirements 
on the applicant or licensee that references this design certification 
so that its plant-specific DCD accurately reflects both generic changes 
to the generic DCD and plant-specific departures made under Section 
VIII. The term ``plant-specific'' would be used in paragraph X.A.2 and 
other sections of this appendix to distinguish between the generic DCD 
that would be incorporated by reference into this appendix, and the 
plant-specific DCD that the applicant would be required to submit under 
paragraph IV.A. The requirement to maintain changes to the generic DCD 
would be explicitly stated to ensure that these changes are not only 
reflected in the generic DCD, which would be maintained by the 
applicant for design certification, but also in the plant-specific DCD. 
Therefore, records of generic changes to the DCD would be required to 
be maintained by both

[[Page 16562]]

entities to ensure that both entities have up-to-date DCDs.
    Paragraph X.A.4.a would require the applicant to maintain a copy of 
the aircraft impact assessment performed to comply with the 
requirements of 10 CFR 50.150(a) for the term of the certification 
(including any period of renewal). This proposed provision, which is 
consistent with 10 CFR 50.150(c)(3), will facilitate any NRC 
inspections of the assessment that the NRC decides to conduct. 
Similarly, the NRC is proposing new paragraph X.A.4.b that would 
require an applicant or licensee who references this appendix to 
maintain a copy of the aircraft impact assessment performed to comply 
with the requirements of 10 CFR 50.150(a) throughout the pendency of 
the application and for the term of the license (including any period 
of renewal). This provision is consistent with 10 CFR 50.150(c)(4). For 
all applicants and licensees, the supporting documentation retained 
onsite should describe the methodology used in performing the 
assessment, including the identification of potential design features 
and functional capabilities to show that the acceptance criteria in 10 
CFR 50.150(a)(1) will be met.
    Paragraph X.A would not place recordkeeping requirements on site-
specific information that is outside the scope of this rule. As 
discussed in paragraph IV.D of this document, the FSAR required by 10 
CFR 52.79 would contain the plant-specific DCD and the site-specific 
information for a facility that references this rule. The phrase 
``site-specific portion of the final safety analysis report'' in 
paragraph X.B.3.c would refer to the information that is contained in 
the FSAR for a facility (required by 10 CFR 52.79) but is not part of 
the plant-specific DCD (required by paragraph IV.A). Therefore, this 
rule would not require that duplicate documentation be maintained by an 
applicant or licensee that references this rule, because the plant-
specific DCD would be part of the FSAR for the facility.
    Paragraph X.B.1 would require applicants or licensees that 
reference this rule to submit reports, which describe departures from 
the DCD and include a summary of the written evaluations. The 
requirement for the written evaluations would be set forth in paragraph 
X.A.1. The frequency of the report submittals would be set forth in 
paragraph X.B.3. The requirement for submitting a summary of the 
evaluations would be similar to the requirement in 10 CFR 50.59(d)(2).
    Paragraph X.B.2 would require applicants or licensees that 
reference this rule to submit updates to the DCD, which include both 
generic changes and plant-specific departures. The frequency for 
submitting updates would be set forth in paragraph X.B.3. The 
requirements in paragraph X.B.3 for submitting the reports and updates 
would vary according to certain time periods during a facility's 
lifetime. If a potential applicant for a COL who references this rule 
decides to depart from the generic DCD prior to submission of the 
application, then paragraph X.B.3.a would require that the updated DCD 
be submitted as part of the initial application for a license. Under 
paragraph X.B.3.b, the applicant may submit any subsequent updates to 
its plant-specific DCD along with its amendments to the application 
provided that the submittals are made at least once per year. Because 
amendments to an application are typically made more frequently than 
once a year, this should not be an excessive burden on the applicant.
    Paragraph X.B.3.b would also require semi-annual submission of the 
reports required by paragraph X.B.1 throughout the period of 
application review and construction. The NRC would use the information 
in the reports to help plan the NRC's inspection and oversight during 
this phase, when the licensee is conducting detailed design, 
procurement of components and equipment, construction, and 
preoperational testing. In addition, the NRC would use the information 
in making its finding on ITAAC under 10 CFR 52.103(g), as well as any 
finding on interim operation under section 189.a.(1)(B)(iii) of the 
AEA. Once a facility begins operation (for a COL under 10 CFR part 52, 
after the Commission has made a finding under 10 CFR 52.103(g)), the 
frequency of reporting would be governed by the requirements in 
paragraph X.B.3.c.

VI. Agreement State Compatibility

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

VII. Availability of Documents

    The NRC is making the documents identified below available to 
interested persons through one or more of the following methods, as 
indicated.
    Public Document Room (PDR). The NRC PDR is located at 11555 
Rockville Pike, Rockville, Maryland 20852, e-mail: 
[email protected].
    Regulations.gov (Web). These documents may be viewed and downloaded 
electronically through the Federal rulemaking Web site, http://www.regulations.gov, by searching under Docket ID NRC-2010-0135.
    NRC's Electronic Reading Room (ERR). The NRC's public electronic 
reading room is located at http://www.nrc.gov/reading-rm.html.

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                    Document                        PDR       Web                    ERR (ADAMS)
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SECY-11-0006, ``Proposed Rule--ESBWR Design            X         X   ML102220172
 Certification''.
Staff Requirements Memorandum for SECY-11-0006,        X         X   ML110670047
 ``Proposed Rule--ESBWR Design Certification''.
GE-Hitachi Nuclear Energy Application for              X         X   ML052450245
 Design Certification of the ESBWR Design.
ESBWR Design Control Document, Revision 9......        X         X   ML103440266
ESBWR Final Safety Evaluation Report...........        X   ........  ML103470210
ESBWR Environmental Assessment.................        X         X   ML102220247
NEDO-33306, Revision 4, ``ESBWR Severe Accident        X   ........  ML102990433
 Mitigation Design Alternatives''.
NEDO-33338, Revision 1, ``ESBWR Feedwater              X   ........  ML091380173
 Temperature Operating Domain Transient and
 Accident Analysis''.
NEDC-33408P, Revision 1, ``ESBWR Steam Dryer--         X   ........  ML102880132
 Plant Based Load Evaluation Methodology``.
Staff Requirements Memorandum for SECY-96-077,         X   ........  ML003754873
 ``Certification of Two Evolutionary Designs''.
SECY-94-084, ``Policy and Technical Issues             X   ........  ML003708068
 Associated with the Regulatory Treatment of
 Non-Safety Systems in Passive Plant Designs''.

[[Page 16563]]

 
Staff Requirements Memorandum for SECY-90-377,         X   ........  ML003707892
 ``Requirements for Design Certification Under
 10 CFR Part 52''.
NUREG-0700, Revision 2, ``Human-Systems                X   ........  ML021700337
 Interface Design Review Guidelines'' (three                         ML021700342
 volumes).                                                           ML021700371
NUREG-0711, Revision 2, ``Human Factors          ........  ........  ML040770540
 Engineering Program Review Model''.
NUREG-0800, Ch. 6.4, Revision 3, ``Control Room        X   ........  ML070550069
 Habitability System''.
NUREG-0800, Ch. 13.5.2.1, Revision 2,                  X   ........  ML070100635
 ``Operating and Emergency Operating
 Procedures''.
NUREG-1242, ``NRC Review of Electric Power             X   ........  ML100610048
 Research Institute's Advanced Light Water                           ML100430013
 Reactor Utility Requirements Document,                              ML063620331
 Evolutionary Plant Designs'' (five volumes).                        ML070600372
                                                                     ML070600373
Regulatory Guide 1.206, Section C.I.1,                 X   ........  ML070630005
 ``Standard Format and Content of Combined
 License Applications--Introduction and General
 Description of the Plant''.
Interim Staff Guidance DC/COL-ISG-8,                   X   ........  ML083310237
 ``Necessary Content of Plant-Specific
 Technical Specifications''.
Regulatory History of Design Certification \3\.        X   ........  ML003761550
----------------------------------------------------------------------------------------------------------------

VIII. Procedures for Access to SUNSI (Including Proprietary 
Information) and SGI for Preparation of Comments on the Proposed ESBWR 
Design Certification Rule

    This section contains instructions regarding how interested persons 
who wish to comment on the proposed design certification may request 
access to documents containing SUNSI (including proprietary information 
\4\), and SGI, in order to prepare their comments. Requirements for 
access to SGI are primarily set forth in 10 CFR parts 2 and 73. This 
notice of proposed rulemaking provides information specific to this 
rulemaking; however, nothing in this notice is intended to conflict 
with the SGI regulations.
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    \3\ The regulatory history of the NRC's design certification 
reviews is a package of documents that is available in NRC's PDR and 
ERR. This history spans the period during which the NRC 
simultaneously developed the regulatory standards for reviewing 
these designs and the form and content of the rules that certified 
the designs.
    \4\ For purposes of this discussion, ``proprietary information'' 
constitutes trade secrets or commercial or financial information 
that are privileged or confidential, as those terms are used under 
the FOIA and the NRC's implementing regulation at 10 CFR part 9.
---------------------------------------------------------------------------

    Interested persons who desire access to SUNSI information on the 
ESBWR design constituting proprietary information should first request 
access to that information from the design certification applicant. A 
request for access should be submitted to the NRC if the applicant does 
not either grant or deny access by the 10-day deadline described below.

Submitting a Request to the NRC for Access

    Within 10 days after publication of this notice of proposed 
rulemaking, any individual or entity who, in order to submit comments 
on the proposed design certification, believes access to information in 
this rulemaking docket that the NRC has categorized as SUNSI or SGI is 
necessary may request access to this information. Requests for access 
to SUNSI or SGI submitted more than 10 days after publication of this 
notice will not be considered absent a showing of good cause for the 
late filing explaining why the request could not have been filed 
earlier.
    The individual or entity requesting access to the information 
(hereinafter, the ``requester'') shall submit a letter requesting 
permission to access SUNSI and/or SGI to the Office of the Secretary, 
U.S. Nuclear Regulatory Commission, Attention: Rulemakings and 
Adjudications Staff, Washington, DC 20555-0001. The expedited delivery 
or courier mail address is: Office of the Secretary, U.S. Nuclear 
Regulatory Commission, Attention: Rulemakings and Adjudications Staff, 
11555 Rockville Pike, Rockville, Maryland 20852. The e-mail address for 
the Office of the Secretary is [email protected]. The 
requester must send a copy of the request to the design certification 
applicant at the same time as the original transmission to the NRC 
using the same method of transmission. Requests to the applicant must 
be sent to Rick E. Kingston, Vice President, ESBWR Licensing, GE-
Hitachi Nuclear Energy, 3901 Castle Hayne Road, MC A65, Wilmington, NC 
28401, e-mail: [email protected]. For purposes of complying with 
this requirement, a ``request'' includes all the information required 
to be submitted to the NRC as set forth in this section.
    The request must include the following information:
    1. The name of this design certification--ESBWR Design 
Certification, the rulemaking identification number RIN 3150-AI85, the 
rulemaking docket number NRC-2010-0135, and a citation to this Federal 
Register notice of proposed rulemaking at the top of the first page of 
the request;
    2. The name, address, e-mail or FAX number of the requester. If the 
requester is an entity, the name of the individual(s) to whom access is 
to be provided, then the address and e-mail or FAX number for each 
individual, and a statement of the authority granted by the entity to 
each individual to review the information and to prepare comments on 
behalf of the entity must be provided. If the requester is relying upon 
another individual to evaluate the requested SUNSI and/or SGI and 
prepare comments, then the name, affiliation, address and e-mail or FAX 
number for that individual must be provided.
    3.(a) If the request is for SUNSI, then the requester's need for 
the information in order to prepare meaningful comments on the proposed 
design certification must be demonstrated. Each of the following areas 
must be addressed with specificity:
    (i) The specific issue or subject matter on which the requester 
wishes to comment;
    (ii) An explanation why information which is publicly available, 
including the publicly available versions of the application and design 
control document, and information on the NRC's docket for the design 
certification application is insufficient to provide the basis for 
developing meaningful comment on the proposed design certification with 
respect to the issue or subject matter described in paragraph 3.(a)(i) 
above; and
    (iii) Information demonstrating that the individual to whom access 
is to be provided has the technical competence

[[Page 16564]]

(demonstrable knowledge, skill, experience, education, training, or 
certification) to understand and use (or evaluate) the requested 
information for a meaningful comment on the proposed design 
certification with respect to the issue or subject matter described in 
paragraph 3.(a)(i) above.
    (b) If the request is for SUNSI constituting proprietary 
information, then a chronology and discussion of the requester's 
attempts to obtain the information from the design certification 
applicant, and the final communication from the requester to the 
applicant and the applicant's response with respect to the request for 
access to proprietary information must be submitted.
    4.(a) If the request is for SGI, then the requester's ``need to 
know'' the SGI as required by 10 CFR 73.2 and 10 CFR 73.22(b)(1) must 
be demonstrated. Consistent with the definition of ``need to know'' as 
stated in 10 CFR 73.2 and 10 CFR 73.22(b)(1), each of the following 
areas must be addressed with specificity:
    (i) The specific issue or subject matter on which the requester 
wishes to comment;
    (ii) An explanation why information which is publicly available, 
including the publicly available versions of the application and design 
control document, and information on the NRC's docket for the design 
certification application is insufficient to provide the basis for 
developing meaningful comment on the proposed design certification with 
respect to the issue or subject matter described in paragraph 4.(a)(i) 
above, and that the SGI requested is indispensible in order to develop 
meaningful comments; \5\ and
---------------------------------------------------------------------------

    \5\ Broad SGI requests under these procedures are unlikely to 
meet the standard for need to know. Furthermore, NRC staff redaction 
of information from requested documents before their release may be 
appropriate to comport with this requirement. The procedures in this 
notice of proposed rulemaking do not authorize unrestricted 
disclosure or less scrutiny of a requester's need to know than 
ordinarily would be applied in connection with either adjudicatory 
or non-adjudicatory access to SGI.
---------------------------------------------------------------------------

    (iii) Information demonstrating that the individual to whom access 
is to be provided has the technical competence (demonstrable knowledge, 
skill, experience, education, training, or certification) to understand 
and use (or evaluate) the requested SGI, in order to develop meaningful 
comments on the proposed design certification with respect to the issue 
or subject matter described in Paragraph 4.(a)(i) above.
    (b) A completed Form SF-85, ``Questionnaire for Non-Sensitive 
Positions,'' must be submitted for each individual who would have 
access to SGI. The completed Form SF-85 will be used by the NRC's 
Office of Administration to conduct the background check required for 
access to SGI, as required by 10 CFR part 2, subpart G, and 10 CFR 
73.22(b)(2), to determine the requester's trustworthiness and 
reliability. For security reasons, Form SF-85 can only be submitted 
electronically through the electronic Questionnaire for Investigations 
Processing (e-QIP) Web site, a secure Web site that is owned and 
operated by the Office of Personnel Management. To obtain online access 
to the form, the requester should contact the NRC's Office of 
Administration at 301-492-3524.\6\
---------------------------------------------------------------------------

    \6\ The requester will be asked to provide his or her full name, 
social security number, date and place of birth, telephone number, 
and e-mail address. After providing this information, the requester 
usually should be able to obtain access to the online form within 
one business day.
---------------------------------------------------------------------------

    (c) A completed Form FD-258 (fingerprint card), signed in original 
ink, and submitted under 10 CFR 73.57(d). Copies of Form FD-258 may be 
obtained by writing the Office of Information Services, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001; by calling 301-415-
7232 or 301-492-7311; or by e-mail: to [email protected]. The 
fingerprint card will be used to satisfy the requirements of 10 CFR 
part 2, 10 CFR 73.22(b)(1), and Section 149 of the Atomic Energy Act 
(AEA) of 1954, as amended, which mandates that all persons with access 
to SGI must be fingerprinted for an Federal Bureau of Investigation 
identification and criminal history records check;
    (d) A check or money order in the amount of $200.00 \7\ payable to 
the U.S. Nuclear Regulatory Commission for each individual for whom the 
request for access has been submitted; and
---------------------------------------------------------------------------

    \7\ This fee is subject to change as specified by the NRC's 
adjustable billing rates.
---------------------------------------------------------------------------

    (e) If the requester or any individual who will have access to SGI 
believes they belong to one or more of the categories of individuals 
relieved from the criminal history records check and background check 
requirements, as stated in 10 CFR 73.59, the requester should also 
provide a statement specifically stating which relief the requester is 
invoking, and explaining the requester's basis (including supporting 
documentation) for believing that the relief is applicable. While 
processing the request, the NRC's Office of Administration, Personnel 
Security Branch, will make a final determination whether the stated 
relief applies. Alternatively, the requester may contact the Office of 
Administration for an evaluation of their status prior to submitting 
the request. Persons who are not subject to the background check are 
not required to complete the SF-85 or Form FD-258; however, all other 
requirements for access to SGI, including the need to know, are still 
applicable.
    Copies of documents and materials required by paragraphs 4(b), (c), 
(d), and (e), as applicable, of this section of this notice of proposed 
rulemaking must be sent to the following address: Office of 
Administration, U.S. Nuclear Regulatory Commission, Personnel Security 
Branch, Mail Stop TWB-05 B32M, Washington, DC 20555-0012.
    These documents and materials should not be included with the 
request letter to the Office of the Secretary, but the request letter 
should state that the forms and fees have been submitted as required 
above.
    5. To avoid delays in processing requests for access to SGI, all 
forms should be reviewed for completeness and accuracy (including 
legibility) before submitting them to the NRC. The NRC will return 
incomplete or illegible packages to the sender without processing.
    6. Based on an evaluation of the information submitted under 
paragraphs 3(a) and (b), or 4(a), (b), (c), and (e) above, as 
applicable, the NRC staff will determine within 10 days of receipt of 
the written access request whether the requester has established a 
legitimate need for SUNSI access or need to know the SGI requested.
    7. For SUNSI access requests, if the NRC staff determines that the 
requester has established a legitimate need for access to SUNSI, the 
NRC staff will notify the requester in writing that access to SUNSI has 
been granted; provided, however, that if the SUNSI consists of 
proprietary information (i.e., trade secrets or confidential or 
financial information), the NRC staff must first notify the applicant 
of the staff's determination to grant access to the requester not less 
than 10 days before informing the requester of the staff's decision. If 
the applicant wishes to challenge the NRC staff's determination, it 
must follow the procedures in paragraph 12 below. The NRC staff will 
not provide the requester access to disputed proprietary information to 
the requester until the procedures in paragraph 12 are completed.
    The written notification to the requester will contain instructions 
on how the requester may obtain copies of the requested documents, and 
any other conditions that may apply to access to those documents. These 
conditions will

[[Page 16565]]

include, but are not necessarily limited to, the signing of a 
protective order setting forth terms and conditions to prevent the 
unauthorized or inadvertent disclosure of SUNSI by each individual who 
will be granted access to SUNSI. Claims that the provisions of such a 
protective order have not been complied with may be filed by calling 
NRC's toll-free safety hotline at 800-695-7403. Please note: Calls to 
this number are not recorded between the hours of 7 a.m. to 5 p.m. 
Eastern Time. However, calls received outside these hours are answered 
by the NRC's Incident Response Operations Center on a recorded line. 
Claims may also be filed via e-mail sent to [email protected], 
or may be sent in writing to the U.S. Nuclear Regulatory Commission, 
ATTN: N. Rivera-Feliciano, Mail Stop T7-D24, Washington, DC 20555-0001.
    8. For requests for access to SGI, if the NRC staff determines that 
the requester has established a need to know the SGI, the NRC's Office 
of Administration will then determine, based upon completion of the 
background check, whether the proposed recipient is trustworthy and 
reliable, as required for access to SGI by 10 CFR 73.22(b). If the 
NRC's Office of Administration determines that the individual or 
individuals are trustworthy and reliable, the NRC will promptly notify 
the requester in writing. The notification will provide the names of 
approved individuals as well as the conditions under which the SGI will 
be provided. Those conditions will include, but are not necessarily 
limited to, the signing of a protective order by each individual who 
will be granted access to SGI. Claims that the provisions of such a 
protective order have not been complied with may be filed by calling 
NRC's toll-free safety hotline at 1-800-695-7403. Please note: Calls to 
this number are not recorded between the hours of 7 a.m. to 5 p.m. 
Eastern Time. However, calls received outside these hours are answered 
by the NRC's Incident Response Operations Center on a recorded line. 
Claims may also be filed via e-mail sent to [email protected], 
or may be sent in writing to the U.S. Nuclear Regulatory Commission, 
ATTN: N. Rivera-Feliciano, Mail Stop T7-D24, Washington, DC 20555-0001. 
Because SGI requires special handling, initial filings with the NRC 
should be free from such specific information. If necessary, the NRC 
will arrange an appropriate setting for transmitting SGI to the NRC.
    9. Release and Storage of SGI. Prior to providing SGI to the 
requester, the NRC staff will conduct (as necessary) an inspection to 
confirm that the recipient's information protection system is 
sufficient to satisfy the requirements of 10 CFR 73.22. Alternatively, 
recipients may opt to view SGI at an approved SGI storage location 
rather than establish their own SGI protection program to meet SGI 
protection requirements.
    10. Filing of Comments on the Proposed Design Certification. Any 
comments in this rulemaking proceeding that are based upon the 
disclosed SUNSI or SGI information must be filed by the requester no 
later than 25 days after receipt of (or access to) that information, or 
the close of the public comment period, whichever is later. The 
commenter must comply with all NRC requirements regarding the 
submission of SUNSI and SGI to the NRC when submitting comments to the 
NRC (including marking and transmission requirements).
    11. Review of Denials of Access.
    (a) If the request for access to SUNSI or SGI is denied by the NRC 
staff, the NRC staff shall promptly notify the requester in writing, 
briefly stating the reason or reasons for the denial.
    (b) Before the NRC's Office of Administration makes an adverse 
determination regarding the trustworthiness and reliability of the 
proposed recipient(s) of SGI, the NRC's Office of Administration, as 
specified by 10 CFR 2.705(c)(3)(iii), must provide the proposed 
recipient(s) any records that were considered in the trustworthiness 
and reliability determination, including those required to be provided 
under 10 CFR 73.57(e)(1), so that the proposed recipient is provided an 
opportunity to correct or explain information.
    (c) Appeals from a denial of access must be made to the NRC's 
Executive Director for Operations (EDO) under 10 CFR 9.29. The decision 
of the EDO constitutes final agency action under 10 CFR 9.29(d).
    12. Predisclosure Procedures for SUNSI Constituting Trade Secrets 
or Confidential Commercial or Financial Information. The NRC will 
follow the procedures in 10 CFR 9.28 if the NRC staff determines, under 
paragraph 7 above, that access to SUNSI constituting trade secrets or 
confidential commercial or financial information will be provided to 
the requester. However, any objection filed by the applicant under 10 
CFR 9.28(b) must be filed within 15 days of the NRC staff notice in 
paragraph 7 above rather than the 30-day period provided for under that 
paragraph. In applying the provisions of 10 CFR 9.28, the applicant for 
the DCR will be treated as the ``submitter.''

IX. Plain Language

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

X. Voluntary Consensus Standards

    The National Technology and Transfer Act of 1995 (Act), Public Law 
104-113, requires that Federal agencies use technical standards that 
are developed or adopted by voluntary consensus standards bodies unless 
using such a standard is inconsistent with applicable law or is 
otherwise impractical. In this proposed rule, the NRC proposes to 
approve the ESBWR standard plant design for use in nuclear power plant 
licensing under 10 CFR part 50 or 52. Design certifications are not 
generic rulemakings establishing a generally applicable standard with 
which all 10 CFR parts 50 and 52 nuclear power plant licensees must 
comply. Design certifications are Commission approvals of specific 
nuclear power plant designs by rulemaking. Furthermore, design 
certifications are initiated by an applicant for rulemaking, rather 
than by the NRC. For these reasons, the NRC concludes that the Act does 
not apply to this proposed rule.

XI. Finding of No Significant Environmental Impact: Availability

    The NRC has determined under NEPA, and the NRC's regulations in 
Subpart A, ``National Environmental Policy Act; Regulations 
Implementing Section 102(2),'' of 10 CFR part 51, ``Environmental 
Protection Regulations for Domestic Licensing and Related Regulatory 
Functions,'' that a proposed design certification rule, if adopted, 
would not be a major Federal action significantly affecting the quality 
of the human environment and, therefore, an environmental impact 
statement (EIS) is not required. The NRC's generic determination in 
this regard is reflected in 10 CFR 51.32(b)(1). The basis for the NRC's 
categorical exclusion in this regard, as discussed in the 2007 final 
rule amending 10 CFR parts 51 and 52 (August 28, 2007; 72 FR 49352-
49566), is based upon the following considerations. A design 
certification rule does not authorize the siting, construction, or 
operation of a facility referencing any particular using design;

[[Page 16566]]

it would only codify the ESBWR design in a rule. The NRC will evaluate 
the environmental impacts and issue an EIS as appropriate under NEPA as 
part of the application for the construction and operation of a 
facility referencing any particular design certification rule.
    In addition, consistent with 10 CFR 51.30(d) and 10 CFR 51.32(b), 
the NRC has prepared a draft EA for the ESBWR design addressing various 
design alternatives to prevent and mitigate severe accidents. The EA is 
based, in part, upon the NRC's review of GEH's evaluation of various 
design alternatives to prevent and mitigate severe accidents in NEDO-
33306, Revision 4, ``ESBWR Severe Accident Mitigation Design 
Alternatives.'' Based upon review of GEH's evaluation, the Commission 
concludes that: (1) GEH identified a reasonably complete set of 
potential design alternatives to prevent and mitigate severe accidents 
for the ESBWR design; (2) none of the potential design alternatives are 
justified on the basis of cost-benefit considerations; and (3) it is 
unlikely that other design changes would be identified and justified 
during the term of the design certification on the basis of cost-
benefit considerations, because the estimated core damage frequencies 
for the ESBWR are very low on an absolute scale. These issues are 
considered resolved for the ESBWR design.
    The Commission is requesting comment on the draft EA. As provided 
in 10 CFR 51.31(b), comments on the draft EA will be limited to the 
consideration of SAMDAs as required by 10 CFR 51.30(d). The Commission 
will prepare a final EA following the close of the comment period for 
the proposed standard design certification. If a final rule is issued, 
all environmental issues concerning SAMDAs associated with the 
information in the final EA and NEDO-33306 will be considered resolved 
for facility applications referencing the ESBWR design if the site 
characteristics at the site proposed in the facility application fall 
within the site parameters specified in NEDO-33306.
    The draft EA, upon which the Commission's finding of no significant 
impact is based, and the ESBWR DCD are available for examination and 
copying at the NRC's Public Document Room, One White Flint North, Room 
O-1 F21, 11555 Rockville Pike, Rockville, Maryland 20852.

XII. Paperwork Reduction Act Statement

    This proposed rule contains new or amended information collection 
requirements that are subject to the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501, et seq.). This rule has been submitted to the Office 
of Management and Budget (OMB) for approval of the information 
collection requirements.
    Type of submission, new or revision: Revision.
    The title of the information collection: Appendix E to 10 CFR Part 
52, ESBWR Design Certification, Proposed Rule.
    Current OMB Approval Number: 3150-0151.
    The form number if applicable: Not applicable.
    How often the collection is required: Semi-annually.
    Who will be required or asked to report: Applicant for a combined 
license or a design certification amendment.
    An estimate of the number of annual responses: 3 (1 response plus 2 
recordkeepers).
    The estimated number of annual respondents: 2.
    An estimate of the total number of hours needed annually to 
complete the requirement or request: Approximately 45 additional burden 
hours (5 hours reporting plus 40 hours recordkeeping).
    Abstract: The NRC proposes to amend its regulations to certify the 
ESBWR standard plant design under Subpart B of 10 CFR part 52. This 
action is necessary so that applicants or licensees intending to 
construct and operate an ESBWR design may do so by referencing this 
DCR. The applicant for certification of the ESBWR design is GE-Hitachi 
Nuclear Energy.
    The NRC is seeking public comment on the potential impact of the 
information collections contained in this proposed rule and on the 
following issues:
    1. Is the proposed information collection necessary for the proper 
performance of the functions of the NRC, including whether the 
information will have practical utility?
    2. Is the estimate of burden accurate?
    3. Is there a way to enhance the quality, utility, and clarity of 
the information to be collected?
    4. How can the burden of the information collection be minimized, 
including the use of automated collection techniques?
    A copy of the OMB clearance package may be viewed free of charge at 
the NRC's Public Document Room, One White Flint North, 11555 Rockville 
Pike, Room O-1 F21, Rockville, MD 20852. The OMB clearance package and 
rule are available at the NRC Web site: http://www.nrc.gov/public-involve/doc-comment/omb/index.html for 60 days after the signature date 
of this notice.
    Send comments on any aspect of these proposed information 
collections, including suggestions for reducing the burden and on the 
above issues, by April 25, 2011 to the Records and FOIA/Privacy 
Services Branch (T-5 F52), U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, or by e-mail to 
[email protected]; and to the Desk Officer, Office of 
Information and Regulatory Affairs, NEOB-10202, (3150-0151), Office of 
Management and Budget, Washington, DC 20503. Comments on the proposed 
information collections may also be submitted via the Federal 
rulemaking Web site, http://www.regulations.gov, Docket ID NRC-2010-
0135. Comments received after this date will be considered if it is 
practical to do so, but assurance of consideration cannot be given to 
comments received after this date.

Public Protection Notification

    The NRC may not conduct or sponsor, and a person is not required to 
respond to, a request for information or an information collection 
requirement unless the requesting document displays a currently valid 
OMB control number.

XIII. Regulatory Analysis

    The NRC has not prepared a regulatory analysis for this proposed 
rule. The NRC prepares regulatory analyses for rulemakings that 
establish generic regulatory requirements applicable to all licensees. 
Design certifications are not generic rulemakings in the sense that 
design certifications do not establish standards or requirements with 
which all licensees must comply. Rather, design certifications are 
Commission approvals of specific nuclear power plant designs by 
rulemaking, which then may be voluntarily referenced by applicants for 
COLs. Furthermore, design certification rulemakings are initiated by an 
applicant for a design certification, rather than the NRC. Preparation 
of a regulatory analysis in this circumstance would not be useful 
because the design to be certified is proposed by the applicant rather 
than the NRC. For these reasons, the Commission concludes that 
preparation of a regulatory analysis is neither required nor 
appropriate.

XIV. Regulatory Flexibility Certification

    Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the 
Commission certifies that this rule would not, if promulgated, have a 
significant economic impact on a substantial number of small entities. 
This proposed rule provides for certification of a nuclear power plant 
design. Neither the design certification applicant, nor

[[Page 16567]]

prospective nuclear power plant licensees who reference this design 
certification rule, fall within the scope of the definition of ``small 
entities'' set forth in the Regulatory Flexibility Act, or the size 
standards set established by the NRC (10 CFR 2.810). Thus, this rule 
does not fall within the purview of the Regulatory Flexibility Act.

XV. Backfitting

    The Commission has determined that this proposed rule does not 
constitute a backfit as defined in the backfit rule (10 CFR 50.109) 
because this design certification does not impose new or changed 
requirements on existing 10 CFR part 50 licensees, nor does it impose 
new or changed requirements on existing DCRs in Appendices A through D 
to 10 CFR part 52. Therefore, a backfit analysis was not prepared for 
this rule.

List of Subjects in 10 CFR Part 52

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

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

    1. The authority citation for 10 CFR part 52 continues to read as 
follows:

    Authority:  Secs. 103, 104, 161, 182, 183, 186, 189, 68 Stat. 
936, 948, 953, 954, 955, 956, as amended, sec. 234, 83 Stat. 444, as 
amended (42 U.S.C. 2133, 2201, 2232, 2233, 2236, 2239, 2282); secs. 
201, 202, 206, 88 Stat. 1242, 1244, 1246, as amended (42 U.S.C. 
5841, 5842, 5846); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note); 
Energy Policy Act of 2005, Pub. L. 109-58, 119 Stat. 594 (2005), 
secs. 147 and 149 of the Atomic Energy Act.

    2. In 10 CFR 52.11, paragraph (b) is revised to read as follows:


Sec.  52.11  Information collection requirements: OMB approval.

* * * * *
    (b) The approved information collection requirements contained in 
this part appear in 10 CFR part 52, 52.7, 52.15, 52.16, 52.17, 52.29, 
52.35, 52.39, 52.45, 52.46, 52.47, 52.57, 52.63, 52.75, 52.77, 52.79, 
52.80, 52.93, 52.99, 52.110, 52.135, 52.136, 52.137, 52.155, 52.156, 
52.157, 52.158, 52.171, 52.177, and appendices A, B, C, D, E, and N to 
this part.
    3. Appendix E to 10 CFR part 52 is added to read as follows:

Appendix E to Part 52--Design Certification Rule for the ESBWR Design

I. Introduction

    Appendix E constitutes the standard design certification for the 
Economic Simplified Boiling-Water Reactor (ESBWR) design, in 
accordance with 10 CFR part 52, Subpart B. The applicant for 
certification of the ESBWR design is GE-Hitachi Nuclear Energy.

II. Definitions

    A. Generic design control document (generic DCD) means the 
document containing the Tier 1 and Tier 2 information and generic 
technical specifications that is incorporated by reference into this 
appendix.
    B. Generic technical specifications (generic TS) means the 
information required by 10 CFR 50.36 and 50.36a for the portion of 
the plant that is within the scope of this appendix.
    C. Plant-specific DCD means that portion of the combined license 
(COL) final safety analysis report (FSAR) that sets forth both the 
generic DCD information and any plant-specific changes to generic 
DCD information.
    D. Tier 1 means the portion of the design-related information 
contained in the generic DCD that is approved and certified by this 
appendix (Tier 1 information). The design descriptions, interface 
requirements, and site parameters are derived from Tier 2 
information. Tier 1 information includes:
    1. Definitions and general provisions;
    2. Design descriptions;
    3. Inspections, tests, analyses, and acceptance criteria 
(ITAAC);
    4. Significant site parameters; and
    5. Significant interface requirements.
    E. Tier 2 means the portion of the design-related information 
contained in the generic DCD that is approved but not certified by 
this appendix (Tier 2 information). Compliance with Tier 2 is 
required, but generic changes to and plant-specific departures from 
Tier 2 are governed by Section VIII of this appendix. Compliance 
with Tier 2 provides a sufficient, but not the only acceptable, 
method for complying with Tier 1. Compliance methods differing from 
Tier 2 must satisfy the change process in Section VIII of this 
appendix. Regardless of these differences, an applicant or licensee 
must meet the requirement in paragraph III.B of this appendix to 
reference Tier 2 when referencing Tier 1. Tier 2 information 
includes:
    1. Information required by 10 CFR 52.47(a) and 52.47(c), with 
the exception of generic TS and conceptual design information;
    2. Supporting information on the inspections, tests, and 
analyses that will be performed to demonstrate that the acceptance 
criteria in the ITAAC have been met;
    3. COL action items (COL license information), which identify 
certain matters that must be addressed in the site-specific portion 
of the FSAR by an applicant who references this appendix. These 
items constitute information requirements but are not the only 
acceptable set of information in the FSAR. An applicant may depart 
from or omit these items, provided that the departure or omission is 
identified and justified in the FSAR. After issuance of a 
construction permit or COL, these items are not requirements for the 
licensee unless such items are restated in the FSAR; and
    4. The availability controls in Appendix 19ACM of the DCD.
    F. Tier 2* means the portion of the Tier 2 information, 
designated as such in the generic DCD, which is subject to the 
change process in paragraph VIII.B.6 of this appendix. This 
designation expires for some Tier 2* information under paragraph 
VIII.B.6 of this appendix.
    G. Departure from a method of evaluation described in the plant-
specific DCD used in establishing the design bases or in the safety 
analyses means:
    1. Changing any of the elements of the method described in the 
plant-specific DCD unless the results of the analysis are 
conservative or essentially the same; or
    2. Changing from a method described in the plant-specific DCD to 
another method unless that method has been approved by the NRC for 
the intended application.
    H. All other terms in this appendix have the meaning set out in 
10 CFR 50.2, 10 CFR 52.1, or Section 11 of the Atomic Energy Act of 
1954, as amended, as applicable.

III. Scope and Contents

    A. All Tier 1, Tier 2 (including the availability controls in 
Appendix 19ACM), and the generic TS in the ESBWR DCD, Revision 9, 
dated December 2010, are approved for incorporation by reference by 
the Director of the Office of the Federal Register under 5 U.S.C. 
552(a) and 1 CFR part 51. You may obtain copies of the generic DCD 
from Rick E. Kingston, Vice President, ESBWR Licensing, GE-Hitachi 
Nuclear Energy, 3901 Castle Hayne Road, MC A65, Wilmington, NC 
28401. Publicly available documents created or received at the NRC 
are available electronically at the NRC's Electronic Reading Room at 
http://www.nrc.gov/reading-rm/adams.html. From this page, the public 
can gain entry into the NRC's Agencywide Documents Access and 
Management System (ADAMS), which provides text and image files of 
NRC's public documents. To view the generic DCD in ADAMS, search 
under ADAMS Accession No. ML103440266. If you do not have access to 
ADAMS or if there are problems in accessing the documents located in 
ADAMS, then contact the NRC's Public Document Room (PDR) reference 
staff at 1-800-397-4209, 301-415-4737, or by e-mail to 
[email protected]. A copy of the generic DCD is also available 
for examination and copying at the NRC PDR, Room O-1F21, One White 
Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. Copies 
are also available for examination at the NRC Library, Two White 
Flint North, 11545 Rockville

[[Page 16568]]

Pike, Rockville, Maryland 20852, telephone: 301-415-5610, e-mail: 
[email protected]. All approved material is available for 
inspection at the National Archives and Records Administration 
(NARA). For information on the availability of this material at 
NARA, call 202-741-6030 or go to http://www.archives.gov/federal-register/cfr/ibr-locations.html. The generic DCD can also be viewed 
at the Federal rulemaking Web site, http://www.regulations.gov, by 
searching for documents filed under Docket ID NRC-2010-0135.
    B. An applicant or licensee referencing this appendix, in 
accordance with Section IV of this appendix, shall incorporate by 
reference and comply with the requirements of this appendix, 
including Tier 1, Tier 2 (including the availability controls in 
Appendix 19ACM of the DCD), and the generic TS except as otherwise 
provided in this appendix. Conceptual design information in the 
generic DCD and the evaluation of severe accident mitigation design 
alternatives in NEDO-33306, Revision 4, ``ESBWR Severe Accident 
Mitigation Design Alternatives,'' are not part of this appendix.
    C. If there is a conflict between Tier 1 and Tier 2 of the DCD, 
then Tier 1 controls.
    D. If there is a conflict between the generic DCD and either the 
application for design certification of the ESBWR design or NUREG-
XXXX, ``Final Safety Evaluation Report Related to Certification of 
the ESBWR Standard Design,'' (FSER), then the generic DCD controls.
    E. Design activities for structures, systems, and components 
that are wholly outside the scope of this appendix may be performed 
using site characteristics, provided the design activities do not 
affect the DCD or conflict with the interface requirements.

IV. Additional Requirements and Restrictions

    A. An applicant for a COL that wishes to reference this appendix 
shall, in addition to complying with the requirements of 10 CFR 
52.77, 52.79, and 52.80, comply with the following requirements:
    1. Incorporate by reference, as part of its application, this 
appendix.
    2. Include, as part of its application:
    a. A plant-specific DCD containing the same type of information 
and using the same organization and numbering as the generic DCD for 
the ESBWR design, either by including or incorporating by reference 
the generic DCD information, and as modified and supplemented by the 
applicant's exemptions and departures;
    b. The reports on departures from and updates to the plant-
specific DCD required by paragraph X.B of this appendix;
    c. Plant-specific TS, consisting of the generic and site-
specific TS that are required by 10 CFR 50.36 and 50.36a;
    d. Information demonstrating that the site characteristics fall 
within the site parameters and that the interface requirements have 
been met;
    e. Information that addresses the COL action items; and
    f. Information required by 10 CFR 52.47(a) that is not within 
the scope of this appendix.
    3. Include, in the plant-specific DCD, the sensitive, 
unclassified, non-safeguards information (SUNSI) (including 
proprietary information) and safeguards information (SGI) referenced 
in the ESBWR generic DCD.
    4. Include, as part of its application, a demonstration that an 
entity other than GE-Hitachi Nuclear Energy is qualified to supply 
the ESBWR design unless GE-Hitachi Nuclear Energy supplies the 
design for the applicant's use.
    B. The Commission reserves the right to determine in what manner 
this appendix may be referenced by an applicant for a construction 
permit or operating license under 10 CFR part 50.

V. Applicable Regulations

    A. Except as indicated in paragraph B of this section, the 
regulations that apply to the ESBWR design are in 10 CFR parts 20, 
50, 73, and 100, codified as of [DATE THE FINAL RULE IS SIGNED BY 
THE SECRETARY OF THE COMMISSION], that are applicable and 
technically relevant, as described in the FSER (NUREG-XXXX).
    B. The ESBWR design is exempt from portions of the following 
regulations:
    1. Paragraph (f)(2)(iv) of 10 CFR 50.34--Contents of 
Applications: Technical Information.

VI. Issue Resolution

    A. The Commission has determined that the structures, systems, 
components, and design features of the ESBWR design comply with the 
provisions of the Atomic Energy Act of 1954, as amended, and the 
applicable regulations identified in Section V of this appendix; and 
therefore, provide adequate protection to the health and safety of 
the public. A conclusion that a matter is resolved includes the 
finding that additional or alternative structures, systems, 
components, design features, design criteria, testing, analyses, 
acceptance criteria, or justifications are not necessary for the 
ESBWR design.
    B. The Commission considers the following matters resolved 
within the meaning of 10 CFR 52.63(a)(5) in subsequent proceedings 
for issuance of a COL, amendment of a COL, or renewal of a COL, 
proceedings held under 10 CFR 52.103, and enforcement proceedings 
involving plants referencing this appendix:
    1. All nuclear safety issues, except for the generic TS and 
other operational requirements such as human factors engineering 
procedure development and training program development in Chapters 
18.9 and 18.10 of the generic DCD, associated with the information 
in the FSER, Tier 1, Tier 2 (including referenced information, which 
the context indicates is intended as requirements, and the 
availability controls in Appendix 19ACM of the DCD), and the 
rulemaking record for certification of the ESBWR design;
    2. All nuclear safety and safeguards issues associated with the 
referenced information in SUNSI (including proprietary information) 
and safeguards information which, in context, are intended as 
requirements in the generic DCD for the ESBWR design, with the 
exception of human factors engineering procedure development and 
training program development in Chapters 18.9 and 18.10 of the 
generic DCD;
    3. All generic changes to the DCD under and in compliance with 
the change processes in paragraphs VIII.A.1 and VIII.B.1 of this 
appendix;
    4. All exemptions from the DCD under and in compliance with the 
change processes in paragraphs VIII.A.4 and VIII.B.4 of this 
appendix, but only for that plant;
    5. All departures from the DCD that are approved by license 
amendment, but only for that plant;
    6. Except as provided in paragraph VIII.B.5.f of this appendix, 
all departures from Tier 2 under and in compliance with the change 
processes in paragraph VIII.B.5 of this appendix that do not require 
prior NRC approval, but only for that plant;
    7. All environmental issues concerning severe accident 
mitigation design alternatives associated with the information in 
the NRC's EA for the ESBWR design (ADAMS Accession No. ML102220247) 
and NEDO-33306, Revision 4, ``ESBWR Severe Accident Mitigation 
Design Alternatives,'' (ADAMS Accession No. ML102990433) for plants 
referencing this appendix whose site characteristics fall within 
those site parameters specified in NEDO-33306.
    C. The Commission does not consider operational requirements for 
an applicant or licensee who references this appendix to be matters 
resolved within the meaning of 10 CFR 52.63(a)(5). The Commission 
reserves the right to require operational requirements for an 
applicant or licensee who references this appendix by rule, 
regulation, order, or license condition.
    D. Except under the change processes in Section VIII of this 
appendix, the Commission may not require an applicant or licensee 
who references this appendix to:
    1. Modify structures, systems, components, or design features as 
described in the generic DCD;
    2. Provide additional or alternative structures, systems, 
components, or design features not discussed in the generic DCD; or
    3. Provide additional or alternative design criteria, testing, 
analyses, acceptance criteria, or justification for structures, 
systems, components, or design features discussed in the generic 
DCD.
    E. The NRC will specify at an appropriate time the procedures to 
be used by an interested person who wishes to review portions of the 
design certification or references containing SGI or SUNSI 
(including proprietary information \8\), for the purpose of 
participating in the hearing required by 10 CFR 52.85, the hearing 
provided under 10 CFR 52.103, or in any other proceeding relating to 
this appendix in which interested persons have a right to request an 
adjudicatory hearing.
---------------------------------------------------------------------------

    \8\ Proprietary information includes trade secrets and 
commercial or financial information obtained from a person that are 
privileged or confidential. 10 CFR 2.390 and 10 CFR part 9.
---------------------------------------------------------------------------

VII. Duration of This Appendix

    This appendix may be referenced for a period of 15 years from 
[DATE 30 DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE 
FEDERAL REGISTER],

[[Page 16569]]

except as provided for in 10 CFR 52.55(b) and 52.57(b). This 
appendix remains valid for an applicant or licensee who references 
this appendix until the application is withdrawn or the license 
expires, including any period of extended operation under a renewed 
license.

VIII. Processes for Changes and Departures

A. Tier 1 Information

    1. Generic changes to Tier 1 information are governed by the 
requirements in 10 CFR 52.63(a)(1).
    2. Generic changes to Tier 1 information are applicable to all 
applicants or licensees who reference this appendix, except those 
for which the change has been rendered technically irrelevant by 
action taken under paragraphs A.3 or A.4 of this section.
    3. Departures from Tier 1 information that are required by the 
Commission through plant-specific orders are governed by the 
requirements in 10 CFR 52.63(a)(4).
    4. Exemptions from Tier 1 information are governed by the 
requirements in 10 CFR 52.63(b)(1) and 52.98(f). The Commission will 
deny a request for an exemption from Tier 1, if it finds that the 
design change will result in a significant decrease in the level of 
safety otherwise provided by the design.

B. Tier 2 Information

    1. Generic changes to Tier 2 information are governed by the 
requirements in 10 CFR 52.63(a)(1).
    2. Generic changes to Tier 2 information are applicable to all 
applicants or licensees who reference this appendix, except those 
for which the change has been rendered technically irrelevant by 
action taken under paragraphs B.3, B.4, B.5, or B.6 of this section.
    3. The Commission may not require new requirements on Tier 2 
information by plant-specific order while this appendix is in effect 
under 10 CFR 52.55 or 52.61, unless:
    a. A modification is necessary to secure compliance with the 
Commission's regulations applicable and in effect at the time this 
appendix was approved, as set forth in Section V of this appendix, 
or to ensure adequate protection of the public health and safety or 
the common defense and security; and
    b. Special circumstances as defined in 10 CFR 50.12(a) are 
present.
    4. An applicant or licensee who references this appendix may 
request an exemption from Tier 2 information. The Commission may 
grant such a request only if it determines that the exemption will 
comply with the requirements of 10 CFR 50.12(a). The Commission will 
deny a request for an exemption from Tier 2, if it finds that the 
design change will result in a significant decrease in the level of 
safety otherwise provided by the design. The grant of an exemption 
to an applicant must be subject to litigation in the same manner as 
other issues material to the license hearing. The grant of an 
exemption to a licensee must be subject to an opportunity for a 
hearing in the same manner as license amendments.
    5.a. An applicant or licensee who references this appendix may 
depart from Tier 2 information, without prior NRC approval, unless 
the proposed departure involves a change to or departure from Tier 1 
information, Tier 2* information, or the TS, or requires a license 
amendment under paragraph B.5.b or B.5.c of this section. When 
evaluating the proposed departure, an applicant or licensee shall 
consider all matters described in the plant-specific DCD.
    b. A proposed departure from Tier 2, other than one affecting 
resolution of a severe accident issue identified in the plant-
specific DCD or one affecting information required by 10 CFR 
52.47(a)(28) to address aircraft impacts, requires a license 
amendment if it would:
    (1) Result in more than a minimal increase in the frequency of 
occurrence of an accident previously evaluated in the plant-specific 
DCD;
    (2) Result in more than a minimal increase in the likelihood of 
occurrence of a malfunction of a structure, system, or component 
(SSC) important to safety and previously evaluated in the plant-
specific DCD;
    (3) Result in more than a minimal increase in the consequences 
of an accident previously evaluated in the plant-specific DCD;
    (4) Result in more than a minimal increase in the consequences 
of a malfunction of an SSC important to safety previously evaluated 
in the plant-specific DCD;
    (5) Create a possibility for an accident of a different type 
than any evaluated previously in the plant-specific DCD;
    (6) Create a possibility for a malfunction of an SSC important 
to safety with a different result than any evaluated previously in 
the plant-specific DCD;
    (7) Result in a design basis limit for a fission product barrier 
as described in the plant-specific DCD being exceeded or altered; or
    (8) Result in a departure from a method of evaluation described 
in the plant-specific DCD used in establishing the design bases or 
in the safety analyses.
    c. A proposed departure from Tier 2 affecting resolution of an 
ex-vessel severe accident design feature identified in the plant-
specific DCD, requires a license amendment if:
    (1) There is a substantial increase in the probability of an ex-
vessel severe accident such that a particular ex-vessel severe 
accident previously reviewed and determined to be not credible could 
become credible; or
    (2) There is a substantial increase in the consequences to the 
public of a particular ex-vessel severe accident previously 
reviewed.
    d. A proposed departure from Tier 2 information required by 10 
CFR 52.47(a)(28) to address aircraft impacts shall consider the 
effect of the changed design feature or functional capability on the 
original aircraft impact assessment required by 10 CFR 50.150(a). 
The applicant or licensee shall describe in the plant-specific DCD 
how the modified design features and functional capabilities 
continue to meet the aircraft impact assessment requirements in 10 
CFR 50.150(a)(1).
    e. If a departure requires a license amendment under paragraph 
B.5.b or B.5.c of this section, it is governed by 10 CFR 50.90.
    f. A departure from Tier 2 information that is made under 
paragraph B.5 of this section does not require an exemption from 
this appendix.
    g. A party to an adjudicatory proceeding for either the 
issuance, amendment, or renewal of a license or for operation under 
10 CFR 52.103(a), who believes that an applicant or licensee who 
references this appendix has not complied with paragraph VIII.B.5 of 
this appendix when departing from Tier 2 information, may petition 
to admit into the proceeding such a contention. In addition to 
compliance with the general requirements of 10 CFR 2.309, the 
petition must demonstrate that the departure does not comply with 
paragraph VIII.B.5 of this appendix. Further, the petition must 
demonstrate that the change bears on an asserted noncompliance with 
an ITAAC acceptance criterion in the case of a 10 CFR 52.103 
preoperational hearing, or that the change bears directly on the 
amendment request in the case of a hearing on a license amendment. 
Any other party may file a response. If, on the basis of the 
petition and any response, the presiding officer determines that a 
sufficient showing has been made, the presiding officer shall 
certify the matter directly to the Commission for determination of 
the admissibility of the contention. The Commission may admit such a 
contention if it determines the petition raises a genuine issue of 
material fact regarding compliance with paragraph VIII.B.5 of this 
appendix.
    6.a. An applicant who references this appendix may not depart 
from Tier 2* information, which is designated with italicized text 
or brackets and an asterisk in the generic DCD, without NRC 
approval. The departure will not be considered a resolved issue, 
within the meaning of Section VI of this appendix and 10 CFR 
52.63(a)(5).
    b. A licensee who references this appendix may not depart from 
the following Tier 2* matters without prior NRC approval. A request 
for a departure will be treated as a request for a license amendment 
under 10 CFR 50.90.
    (1) Fuel mechanical and thermal-mechanical design evaluation 
reports, including fuel burnup limits.
    (2) Control rod mechanical and nuclear design reports.
    (3) Fuel nuclear design report.
    (4) Critical power correlation.
    (5) Fuel licensing acceptance criteria.
    (6) Control rod licensing acceptance criteria.
    (7) Mechanical and structural design of spent fuel storage 
racks.
    c. A licensee who references this appendix may not, before the 
plant first achieves full power following the finding required by 10 
CFR 52.103(g), depart from the following Tier 2* matters except 
under paragraph B.6.b of this section. After the plant first 
achieves full power, the following Tier 2* matters revert to Tier 2 
status and are subject to the departure provisions in paragraph B.5 
of this section.
    (1) ASME Boiler and Pressure Vessel Code, Section III.
    (2) American Concrete Institute 349 and American National 
Standards Institute/

[[Page 16570]]

American Institute of Steel Construction-N690.
    (3) Motor-operated valves.
    (4) Equipment seismic qualification methods.
    (5) Piping design acceptance criteria.
    (6) Instrument setpoint methodology.
    (7) Safety-Related Distribution Control and Information System 
performance specification and architecture.
    (8) Safety System Logic and Control hardware and software.
    (9) Human factors engineering design and implementation.
    (10) First of a kind testing for reactor stability (first plant 
only).
    (11) Reactor precritical heatup with reactor water cleanup/
shutdown cooling (first plant only).
    (12) Isolation condenser system heatup and steady state 
operation (first plant only).
    (13) Power maneuvering in the feedwater temperature operating 
domain (first plant only).
    (14) Load maneuvering capability (first plant only).
    (15) Defense-in-depth stability solution evaluation test (first 
plant only).
    d. Departures from Tier 2* information that are made under 
paragraph B.6 of this section do not require an exemption from this 
appendix.

C. Operational Requirements

    1. Generic changes to generic TS and other operational 
requirements that were completely reviewed and approved in the 
design certification rulemaking and do not require a change to a 
design feature in the generic DCD are governed by the requirements 
in 10 CFR 50.109. Generic changes that require a change to a design 
feature in the generic DCD are governed by the requirements in 
paragraphs A or B of this section.
    2. Generic changes to generic TS and other operational 
requirements are applicable to all applicants who reference this 
appendix, except those for which the change has been rendered 
technically irrelevant by action taken under paragraphs C.3 or C.4 
of this section.
    3. The Commission may require plant-specific departures on 
generic TS and other operational requirements that were completely 
reviewed and approved, provided a change to a design feature in the 
generic DCD is not required and special circumstances as defined in 
10 CFR 2.335 are present. The Commission may modify or supplement 
generic TS and other operational requirements that were not 
completely reviewed and approved or require additional TS and other 
operational requirements on a plant-specific basis, provided a 
change to a design feature in the generic DCD is not required.
    4. An applicant who references this appendix may request an 
exemption from the generic TS or other operational requirements. The 
Commission may grant such a request only if it determines that the 
exemption will comply with the requirements of 10 CFR 52.7. The 
grant of an exemption must be subject to litigation in the same 
manner as other issues material to the license hearing.
    5. A party to an adjudicatory proceeding for the issuance, 
amendment, or renewal of a license, or for operation under 10 CFR 
52.103(a), who believes that an operational requirement approved in 
the DCD or a TS derived from the generic TS must be changed may 
petition to admit such a contention into the proceeding. The 
petition must comply with the general requirements of 10 CFR 2.309 
and must demonstrate why special circumstances as defined in 10 CFR 
2.335 are present, or demonstrate compliance with the Commission's 
regulations in effect at the time this appendix was approved, as set 
forth in Section V of this appendix. Any other party may file a 
response to the petition. If, on the basis of the petition and any 
response, the presiding officer determines that a sufficient showing 
has been made, the presiding officer shall certify the matter 
directly to the Commission for determination of the admissibility of 
the contention. All other issues with respect to the plant-specific 
TS or other operational requirements are subject to a hearing as 
part of the license proceeding.
    6. After issuance of a license, the generic TS have no further 
effect on the plant-specific TS. Changes to the plant-specific TS 
will be treated as license amendments under 10 CFR 50.90.

IX. Inspections, Tests, Analyses, and Acceptance Criteria (ITAAC)

    [Reserved]

X. Records and Reporting

A. Records

    1. The applicant for this appendix shall maintain a copy of the 
generic DCD that includes all generic changes it makes to Tier 1 and 
Tier 2, and the generic TS and other operational requirements. The 
applicant shall maintain the SUNSI (including proprietary 
information) and safeguards information referenced in the generic 
DCD for the period that this appendix may be referenced, as 
specified in Section VII of this appendix.
    2. An applicant or licensee who references this appendix shall 
maintain the plant-specific DCD to accurately reflect both generic 
changes to the generic DCD and plant-specific departures made under 
Section VIII of this appendix throughout the period of application 
and for the term of the license (including any period of renewal).
    3. An applicant or licensee who references this appendix shall 
prepare and maintain written evaluations which provide the bases for 
the determinations required by Section VIII of this appendix. These 
evaluations must be retained throughout the period of application 
and for the term of the license (including any period of renewal).
    4.a. The applicant for the ESBWR design shall maintain a copy of 
the aircraft impact assessment performed to comply with the 
requirements of 10 CFR 50.150(a) for the term of the certification 
(including any period of renewal).
    b. An applicant or licensee who references this appendix shall 
maintain a copy of the aircraft impact assessment performed to 
comply with the requirements of 10 CFR 50.150(a) throughout the 
pendency of the application and for the term of the license 
(including any period of renewal).

B. Reporting

    1. An applicant or licensee who references this appendix shall 
submit a report to the NRC containing a brief description of any 
plant-specific departures from the DCD, including a summary of the 
evaluation of each. This report must be filed in accordance with the 
filing requirements applicable to reports in 10 CFR 52.3.
    2. An applicant or licensee who references this appendix shall 
submit updates to its DCD, which reflect the generic changes to and 
plant-specific departures from the generic DCD made under Section 
VIII of this appendix. These updates shall be filed under the filing 
requirements applicable to final safety analysis report updates in 
10 CFR 52.3 and 50.71(e).
    3. The reports and updates required by paragraphs X.B.1 and 
X.B.2 of this appendix must be submitted as follows:
    a. On the date that an application for a license referencing 
this appendix is submitted, the application must include the report 
and any updates to the generic DCD.
    b. During the interval from the date of application for a 
license to the date the Commission makes its finding required by 10 
CFR 52.103(g), the report must be submitted semi-annually. Updates 
to the plant-specific DCD must be submitted annually and may be 
submitted along with amendments to the application.
    c. After the Commission makes the finding required by 10 CFR 
52.103(g), the reports and updates to the plant-specific DCD must be 
submitted, along with updates to the site-specific portion of the 
final safety analysis report for the facility, at the intervals 
required by 10 CFR 50.59(d)(2) and 50.71(e)(4), respectively, or at 
shorter intervals as specified in the license.

    Dated at Rockville, Maryland, this 16th day of March 2011.

    For the Nuclear Regulatory Commission.

Annette Vietti-Cook,
Secretary of the Commission.

[FR Doc. 2011-6839 Filed 3-23-11; 8:45 am]
BILLING CODE 7590-01-P