[Federal Register Volume 68, Number 147 (Thursday, July 31, 2003)]
[Notices]
[Pages 45086-45122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-19321]



[[Page 45085]]

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

Part IV





Nuclear Regulatory Commission





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



Yucca Mountain Review Plan, NUREG-1804, Revision 2, Final Report; 
Notice

  Federal Register / Vol. 68, No. 147 / Thursday, July 31, 2003 / 
Notices  

[[Page 45086]]


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

NUCLEAR REGULATORY COMMISSION


Yucca Mountain Review Plan, NUREG-1804, Revision 2, Final Report

AGENCY: Nuclear Regulatory Commission.

ACTION: Notice of availability and public comments and responses.

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

SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is announcing the 
availability of ``Yucca Mountain Review Plan, NUREG-1804, Revision 2, 
Final Report,'' public comments on that document and NRC response to 
comments. The ``Yucca Mountain Review Plan'' provides guidance to NRC 
staff for evaluating a potential license application to receive and 
possess high-level radioactive waste at a geologic repository 
constructed or operated at Yucca Mountain, Nevada.

ADDRESSES: Copies of any documents related to this action may be 
examined at the NRC Public Document Room, One White Flint North, Public 
File Area O1-F21, 11555 Rockville Pike, Rockville, Maryland. Documents 
are also available electronically at NRC's Public Electronic Reading 
Room on the Internet at http://www.nrc.gov/reading-rm.html. From this 
site, the public can gain entry into NRC's Agencywide Documents Access 
and Management System, which provides text and image files of NRC's 
public documents. For more information, contact NRC's Public Document 
Room Reference staff by telephone at (800) 397-4209: (301) 415-4737: or 
e-mail: [email protected].
    The document is also available at NRC's Web site at: http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1804/. A hard 
copy may also be purchased from one of these two sources: (1) The 
Superintendent of Documents, U.S. Government Printing Office, P.O. Box 
37082, Washington, DC 20402-9328, Internet: http://bookstore.gpo.gov. 
Telephone: 202-512-1800, Fax: 202-512-2250; or (2) The National 
Technical Information Service, Springfield, VA 22161-0002, Internet: 
http://www.ntis.gov. Telephone: 1-800-553-6847 or 703-605-6000. A copy 
of the ``Yucca Mountain Review Plan, NUREG-1804, Revision 2, Final 
Report'' is also available for inspection, and copying for a fee, in 
NRC's Public Document Room, One White Flint North, Public File Area O1-
F21, 11555 Rockville Pike, Rockville, Maryland.

FOR FURTHER INFORMATION CONTACT: Jeffrey A. Ciocco, Office of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Mail Stop T-7F3, Washington, DC 20555-0001, telephone (301) 415-6391, 
e-mail: [email protected].

SUPPLEMENTARY INFORMATION: In preparing ``Yucca Mountain Review Plan, 
NUREG-1804, Revision 2, Final Report,'' the U.S. Nuclear Regulatory 
Commission (NRC) staff carefully reviewed and considered more than 900 
discrete comments received during the public comment period in about 35 
individual letters and extracted from the transcripts of three public 
meetings. To facilitate the analysis, NRC staff grouped all written and 
oral comments on the Yucca Mountain Review Plan into the following 11 
major topic areas:
    (1) Introduction;
    (2) Acceptance Review;
    (3) General Information;
    (4) Preclosure Period;
    (5) Postclosure Period;
    (6) Research and Development Program to Resolve Safety Issues;
    (7) Performance Confirmation;
    (8) Administrative and Programmatic Areas;
    (9) Structure of the Yucca Mountain Review Plan;
    (10) Selected Topics; and
    (11) Other Comments.
    Throughout this response to public comments, references to Yucca 
Mountain Review Plan sections use the section numbering that was in 
Revision 2, ``Draft Report for Comment,'' published in March 2002. As a 
result of changes to address public comments, Chapter 1 of the draft 
Yucca Mountain Review Plan is now Appendix A in Revision 2, ``Final 
Report,'' and Chapter 2 is now Appendix B. Consequently, Chapter 1 is 
the ``Review Plan for General Information,'' and the ``Review Plan for 
Safety Analysis Report'' is now Chapter 2. The numbering of sections 
throughout the plan has been modified accordingly. For example, Section 
3.2.1 in the ``Draft Report for Comment'' is now Section 1.2.1 in the 
``Final Report,'' and Section 4.2.1.3.7 in the ``Draft Report for 
Comment'' is Section 2.2.1.3.7 in the ``Final Report.''

1 Introduction

1.1 The U.S. Nuclear Regulatory Commission Staff Licensing Review

    Issue 1: Will NRC staff conduct a thorough licensing review?
    Comment. A number of commenters expressed concern about the 
statement in the Yucca Mountain Review Plan ``Introduction'' that NRC 
staff would conduct limited in-depth, detailed analyses and would not 
seek scientific precision. Commenters disagreed with the statement, in 
the Yucca Mountain Review Plan ``Introduction,'' that a licensing 
review is not intended to be a detailed evaluation of all aspects of 
facility operations.
    Another commenter stated the Yucca Mountain Review Plan appeared to 
be a menu of options rather than a plan for a thorough regulatory 
review using a risk-informed, performance-based decision process to 
review the Yucca Mountain license application.
    Commenters stated that the Yucca Mountain Review Plan is subjective 
in nature and appears to be the same, or more lenient than, the process 
used for power reactors. Other commenters noted the lack of a 
performance history to support establishing defense-in-depth measures 
and safety margins, and suggested that any assumptions must be 
adequately supported and justified.
    A commenter stated the risk-informed basis of the review plan and 
the lack of definitive criteria allows the U.S. Department of Energy 
(DOE) to determine the level of importance of almost all aspects of the 
repository program and allows DOE to determine the level of NRC review 
effort. A commenter also stated that the licensing review process must 
not only identify discrepancies but must also document them.
    Response. NRC implements a licensing process in which a license 
applicant has the responsibility to demonstrate that nuclear material 
can be safely received and possessed, and a nuclear facility can be 
safely operated, in accordance with regulations. NRC staff licensing 
review determines whether this demonstration of compliance with 
regulations is adequate. The regulatory standard for a high-level waste 
repository at Yucca Mountain is ``reasonable assurance'' for preclosure 
matters, and ``reasonable expectation'' for postclosure matters. NRC 
regulations require a license applicant to provide information that is 
supported by a sound scientific and technical basis.
    While NRC staff reviews the entire license application, the amount 
of information required to demonstrate that regulatory requirements are 
met may vary depending on the importance of the information. 
Specifically, for a risk-informed, performance-based regulatory 
program, NRC staff focuses on those areas that have been shown to have 
the greatest importance to public health and safety. Areas requiring 
detailed, NRC staff independent analyses are determined by NRC staff 
and reviewed to the level necessary to confirm analyses in order to 
make a reasonable assurance or reasonable expectation determination.

[[Page 45087]]

    The Yucca Mountain Review Plan facilitates a risk-informed, 
performance-based review and allows for flexibility in the level of 
detail required for this review. The Commission addressed the use of a 
risk-informed, performance-based review for a potential Yucca Mountain 
repository licensing proceeding in its ``Statement of Considerations'' 
for 10 CFR part 63 (66 FR 55732, 55736-55737, November 2, 2001) as 
follows.

    In developing these criteria, the Commission sought to establish 
a coherent body of risk-informed, performance-based criteria for 
Yucca Mountain that is compatible with the Commission's overall 
philosophy of risk-informed, performance-based regulation [``Use of 
Probabilistic Risk Assessment Methods in Nuclear Regulatory 
Activities--Final Policy Statement'' (60 FR 42622; August 16, 
1995)]. Stated succinctly, risk-informed, performance-based 
regulation is an approach in which risk insights, engineering 
analysis and judgment (e.g., defense in depth), and performance 
history are used to: (1) Focus attention on the most important 
activities, (2) establish objective criteria for evaluating 
performance, (3) develop measurable or calculable parameters for 
monitoring system and licensee performance, (4) provide flexibility 
to determine how to meet the established performance criteria in a 
way that will encourage and reward improved outcomes, and (5) focus 
on the results as the primary basis for regulatory decision-making.

    Relevant defense-in-depth, safety margin, and performance history 
information from other facilities can be applied to a high-level waste 
repository. Many aspects of design and performance for nuclear 
facilities are analogous to those that would be used for a high-level 
waste repository. For example, there is extensive regulatory guidance 
on design and implementation of radiation health physics programs at 
nuclear facilities. Because this information would be used in review of 
a license application for a proposed repository at Yucca Mountain, the 
Yucca Mountain Review Plan references such regulatory guidance.
    To clarify the risk-informed, performance-based review, the 
``Introduction'' section of the draft Yucca Mountain Review Plan (now 
Appendix A) and the ``Acceptance Review'' section (now Appendix B) have 
been modified, as appropriate, to clarify the scope of NRC staff's 
licensing review.
    Issue 2: Does the Yucca Mountain Review Plan assume that all 
licensing issues will be resolved and a license for a high-level waste 
repository at Yucca Mountain will be approved?
    Comment. A commenter was concerned that the statement in the draft 
Yucca Mountain Review Plan ``Introduction'' that NRC staff will resolve 
issues using its technical understanding implied that all issues will 
be resolved in favor of licensing.
    Response. The language in the draft Yucca Mountain Review Plan 
``Introduction'' was not intended to suggest that NRC staff had 
prejudged the acceptability of a license application for Yucca 
Mountain. A conclusion as to whether all licensing issues are resolved 
is premature. NRC staff must first conduct a detailed technical review 
of the license application and consider whether information in DOE's 
application satisfies regulatory requirements and demonstrates that 
public health and safety, and environment can be protected.
    NRC staff revised the language in the Yucca Mountain Review Plan to 
clarify this point.
    Issue 3: Does NRC have adequate authority to impose license 
conditions?
    Comment. Two commenters expressed concern that NRC lacked authority 
to impose and enforce license conditions because the ``Introduction'' 
of the draft Yucca Mountain Review Plan states that an applicant must 
agree to any license conditions. The commenters are concerned that 
applicants can reject or negotiate license conditions with the party 
having the greater political power having the advantage. The commenters 
also expressed concern with the statement in the Yucca Mountain Review 
Plan ``Introduction'' that the Commission has no authority to compel an 
applicant to come forward with or prepare a different proposal.
    Response. The language in the ``Introduction'' was intended to 
state that license conditions should be discussed with the licensee and 
imposed only as necessary to meet the reasonable assurance or 
reasonable expectation standard. It was not intended to suggest that 
the Commission lacks the authority to impose license conditions. In 
fact, 10 CFR 63.42 provides that the ``Commission shall include any 
license conditions, including license specifications, it considers 
necessary to protect the health and safety of the public, the common 
defense and security, and environmental values'' in any license issued 
under 10 CFR part 63.
    The Commission has authority to require regulatory compliance and 
protection of public health and safety and the environment. The 
Commission, however, cannot mandate that an applicant submit an 
application or adopt a specific design or analysis. The Commission has 
the authority to deny an application, grant an application, or grant an 
application with conditions. Unless the Commission concludes that 
regulations will be complied with and a facility will be safely 
operated and material safely received and possessed, a license will not 
be granted.
    The ``Introduction'' section of the Yucca Mountain Review Plan has 
been modified to clarify NRC's authority.
    Issue 4: When will the Yucca Mountain Review Plan be finalized?
    Comment. One commenter stated that NRC should consider and 
incorporate the comments received as soon as practicable after the 
close of the comment period on the Yucca Mountain Review Plan.
    Response. Consistent with the comment and NRC's responsibility to 
provide guidance on a timely basis, this Federal Register notice 
indicates the availability of the Yucca Mountain Review Plan, NUREG-
1804, Revision 2, Final Report, well in advance of the projected 
December 2004 DOE license application.

2 Acceptance Review

2.1 Acceptance Review Process

    Issue 1: Will an acceptance review of a license application for a 
high-level waste repository at Yucca Mountain be adequate?
    Comment. Commenters expressed concern about the statement in the 
``Acceptance Review'' section of the draft Yucca Mountain Review Plan 
that NRC staff does not determine the technical adequacy of information 
during the acceptance review and the potential for NRC staff to accept 
biased and erroneous information and the need for NRC to determine the 
accuracy and adequacy of information.
    Response. The purpose of the acceptance review is to determine 
whether the application can be docketed, that is, whether the 
application is complete and contains sufficient information to enable 
NRC staff to conduct its detailed licensing review. The acceptance 
review does not presuppose what that licensing decision will be and, 
therefore, does not evaluate the technical adequacy of the information. 
If the license application passes the acceptance review, the 
application would be docketed, and the detailed technical review would 
begin. During the detailed technical review, NRC staff would determine 
whether the submitted information is accurate and demonstrates that 
regulatory requirements are met. If the license application fails the 
acceptance review (for example, it is incomplete and lacks sufficient 
information to support the

[[Page 45088]]

detailed licensing review), the license application would be rejected 
and returned to DOE, or NRC would identify the deficiencies and request 
additional information from DOE.
    To allow NRC staff sufficient time to conduct a thorough acceptance 
review, NRC anticipates that the review can reasonably be completed 
within 90 days after the submission of the license application. During 
that time, the NRC staff will determine whether the application is 
complete and contains sufficient information for the NRC staff to 
conduct a detailed technical review. If the application is found 
acceptable for docketing, a notice would published in the Federal 
Register offering an opportunity for a formal adjudicatory hearing and 
public participation in the licensing process.
    The ``Acceptance Review'' section of the Yucca Mountain Review Plan 
has been modified to clarify the purpose of the acceptance review.
    Issue 2: What does completeness of information mean with respect to 
the acceptance review?
    Comment. One commenter questioned the validity of the option 
``Accept, request additional information'' that is contained within the 
checklist in the draft Yucca Mountain Review Plan section on Acceptance 
Review. The commenter expressed concerned that this option could lead 
to the incorrect impression that specific issues had been resolved, 
when in fact, more information is required for the detailed technical 
review.
    Another commenter stated that use of the term ``complete,'' in the 
Acceptance Review section of the draft Yucca Mountain Review Plan is 
confusing and recommended that this section be clarified to state that 
the degree of information available and appropriate for specific 
subject areas in the review plan may vary with the stage of repository 
development.
    Response. The use of the option ``accept, request additional 
information'' is consistent with other NRC regulatory programs and the 
purpose of an acceptance review.
    An acceptance review is conducted to determine whether the 
application is acceptable for docketing, that is, whether the 
application is complete and contains sufficient information to support 
a detailed licensing review. An application could be found deficient in 
an acceptance review due to the failure to submit required documents, 
or because there are omitted sections, illegible figures, or missing 
analyses.
    If deficiencies are limited, NRC staff can proceed with a detailed 
licensing review while awaiting additional specific information from 
the applicant, provided the applicant provides omitted information in a 
timely manner.
    The NRC staff decision, at the acceptance review stage, to accept 
or reject an application would be based on consideration of the 
submitted information and the importance of the missing information for 
beginning the detailed technical review.
    The ``Acceptance Review'' section of the Yucca Mountain Review Plan 
has been modified to clarify the purpose of the acceptance review.

3 General Information

3.1 Content of the General Information Section of the Yucca Mountain 
Review Plan

    Issue: What is the nature of the inspection and testing, of waste 
forms and waste packages listed in the ``General Information'' section 
of the draft Yucca Mountain Review Plan?
    Comment. One commenter asked the purpose of the inspection and 
testing of waste forms and waste packages included in the ``General 
Information'' section of the Yucca Mountain Review Plan. Another 
commenter asked whether Naval reactor fuel would be inspected.
    Response. Section 3.1, ``General Information,'' of the draft Yucca 
Mountain Review Plan provides procedures and acceptance criteria for 
review of general information that is required to be in a license 
application for a high-level waste repository at Yucca Mountain in 
accordance with 10 CFR 63.21(b)(1). Review Method 2, ``General Nature 
of the Geologic Repository Operations Area Activities,'' of this 
section provides guidance to NRC staff to confirm that DOE has provided 
a summary description of the proposed geologic repository operations 
area operations, including information on plans for the inspection and 
testing of waste forms and waste packages as they are received. The 
associated Acceptance Criterion 2 specifies that these plans should 
have been provided. The ``Review Method'' indicates that a detailed 
technical review of this information would be conducted using Section 
4.5.6, ``Plans for Conduct of Normal Activities, Including Maintenance, 
Surveillance, and Periodic Testing,'' of the draft Yucca Mountain 
Review Plan.
    The purpose of the inspection and testing plans is to ensure that 
waste forms and waste packages arriving at a repository are intact and 
are functioning properly. Should waste forms or waste packages not be 
intact or not functioning properly, DOE would be required to take 
actions to place them in a safe condition.
    DOE has the authority and the responsibility to characterize, 
inspect, and monitor Naval reactor fuel. Additionally, the 
characteristics of Naval fuel and its associated materials and 
compounds must be considered in DOE's demonstration of compliance with 
preclosure and postclosure performance objectives.
    No changes to the Yucca Mountain Review Plan were made as a result 
of this comment.

3.2 Adequacy of Site Characterization

    Issue 1: Would there be a need for additional site characterization 
work once a license application for a potential high-level waste 
repository at Yucca Mountain is submitted?
    Comment. Commenters expressed concern about Acceptance Criterion 3 
in Section 3.5, ``Description of Site Characterization Work,'' of the 
draft Yucca Mountain Review Plan. This acceptance criterion addresses 
limitations that would qualify the descriptions of site 
characterization work and notes that the license application would have 
to identify any ``additional site characterization work necessary to 
increase basic scientific understanding of any significant feature, 
event, and process.'' The commenters asked why a license application 
would be accepted if the applicant had not finished site 
characterization work or did not have a scientific understanding of any 
feature, event, or process. Other commenters noted that other licenses 
issued for shorter period are not granted until the applicants have 
completed their evaluations and that incomplete site characterization 
should not be relegated to the ``Performance Confirmation Program'' or 
to the ``Research and Development Program to Resolve Safety 
Questions.''
    Response. A license for a potential high-level waste repository at 
Yucca Mountain can not be granted unless the applicant has 
demonstrated, and NRC has determined, regulatory requirements are met. 
Under 10 CFR 63.15, DOE is required to conduct a program of site 
characterization, with respect to the Yucca Mountain site, before DOE 
submits a license application. The statement in the review plan 
acknowledges that knowledge about the site and repository will evolve 
over the life-cycle of a repository as the required performance 
confirmation program continues in accordance with 10 CFR 63, subpart F. 
The objectives of the performance confirmation program is to confirm 
the assumptions, data and analyses that led to the findings that

[[Page 45089]]

permitted construction of the repository and subsequent emplacement of 
waste. Per the requirements of 10 CFR 63.131, the program must provide 
data that indicate, where practicable, whether ``[a]ctual subsurface 
conditions encountered and changes to those conditions during 
construction and waste emplacement operations are within the limits 
assumed in the licensing review.'' Also, the performance confirmation 
program must be started during site characterization and continue until 
permanent closure.
    This section of the Yucca Mountain Review Plan has been modified to 
clarify the site characterization description.
    Issue 2: Should the definition of the location and characteristics 
of the reasonably maximally exposed individual be clarified?
    Comment. One commenter stated that Review Method 2 of draft Yucca 
Mountain Review Plan, Section 3.5, ``Description of Site 
Characterization Work,'' incorrectly stated that the location and 
characteristics of the reasonably maximally exposed individual had 
already been specified by regulation. The commenter argued that it is 
the responsibility of DOE to propose these details in its license 
application.
    Response. The Yucca Mountain Review Plan text has been revised 
consistent with 10 CFR 63.312 to reflect the required location and 
characteristics of the reasonably maximally exposed individual.

3.3 Material Control and Accounting Program

    Issue 1: What level of detail is appropriate for the material 
control and accounting program for a construction authorization?
    Comment. One commenter noted that the information on material 
control and accounting activities may be in rudimentary form and not as 
detailed as other areas at the construction authorization stage. 
Commenters concluded that the related information would not need to be 
complete at the time of construction authorization application. 
Commenters further suggested that the license application should 
describe the material control and accounting program and contain a 
commitment to meet the requirements at 10 CFR 63.78.
    Response. Pursuant to 10 CFR part 63, there are specific 
requirements for the material control and accounting program that go 
beyond a simple commitment at the time of application for a 
construction authorization. Pursuant to 10 CFR 63.21(b), a license 
application must contain a description of the material control and 
accounting program to meet the requirements of 10 CFR 63.78, including 
design basis information, an assessment of potential impact of the 
material control and accounting program on design features, and a 
description of physical aspects of the material control and accounting 
program.
    The introductory paragraph to Section 3.4, ``Material Control and 
Accounting Program,'' of the draft Yucca Mountain Review Plan has been 
modified to clarify these requirements.
    Issue 2: How will spent nuclear fuel and high-level radioactive 
waste in storage be inventoried?
    Comment. One commenter noted that there are no specific guidelines 
in the Yucca Mountain Review Plan for a detailed inventory process of 
spent nuclear fuel and high-level radioactive waste after the waste is 
placed within sealed disposal canisters. Another commenter stated that 
inventory of emplaced waste would be ensured by controlling access to 
the subsurface.
    Response. The Yucca Mountain Review Plan states, in accordance with 
10 CFR 63.21, that the applicant must provide a description of how 
physical inventories of the repository will be planned, conducted, 
assessed, and reported. Consistent with the performance-based 
regulations in 10 CFR part 63, the Yucca Mountain Review Plan does not 
prescribe the methods for a demonstration of compliance. Accordingly, 
the applicant has the flexibility to design and implement a material 
control and accounting program that meets regulatory requirements.
    No changes have been made to the Yucca Mountain Review Plan in 
response to this comment.
    Issue 3: Under what conditions would spent nuclear fuel or high-
level waste be transferred out of the geologic repository operations 
area?
    Comment. One commenter asked for a definition of conditions that 
would require movement of waste from a repository.
    Response. The geologic repository operations area is defined by 10 
CFR part 63 as a high-level radioactive waste facility that is part of 
a geologic repository, including both surface and subsurface areas, 
where waste handling activities are conducted. As the Commission has 
previously indicated (66 FR 55732, 55743, November 2, 2001) ``[w]aste 
retrieval is intended to be an unusual event only to be undertaken to 
protect public health and safety.''
    No changes were made to the Yucca Mountain Review Plan as a result 
of this comment.
    Issue 4: Should the Yucca Mountain Review Plan define the quantity 
of material that would initiate reporting the loss of nuclear 
materials?
    Comment. One commenter suggested that the review methods and 
acceptance criteria of draft Yucca Mountain Review Plan Section 3.4, 
``Material Control and Accounting Program,'' that address reporting 
requirements for lost nuclear material should apply not only to a 
significant quantity, but to any quantity of material that may be 
missing. Another commenter asked who would be responsible for 
preventing theft of special nuclear material.
    Response. NRC must be notified of any loss of special nuclear 
material.
    As is the case for other NRC-licensed facilities, the licensee, in 
this case DOE, is responsible for the safe and secure operation of the 
facility and for safe receipt and possession, including prevention of 
theft of nuclear material. NRC staff will review the license 
application to determine whether DOE has adequate physical protection 
and material control and accountability programs. Additionally, if a 
license is issued, NRC staff would conduct inspections to verify 
whether physical protection, and material control and accountability 
programs, are being properly implemented.
    The term ``significant quantity'' was deleted from this section of 
the Yucca Mountain Review Plan.
    Issue 5: Should the Yucca Mountain Review Plan address storage of 
emplaced waste?
    Comment. One commenter expressed concern that the statement ``the 
reviewer should consider that emplaced waste is stored until the 
repository is closed'' in the Yucca Mountain Review Plan implies 
(because of requirements in 10 CFR 72.72) that physical inventory would 
be required at least yearly for waste packages in the subsurface. The 
commenter suggested deleting this statement, arguing that 10 CFR 63.2 
defines disposal as ``the emplacement of radioactive waste in a 
geologic repository with the intent of leaving it there permanently,'' 
which distinguishes disposal from storage operations. The commenter 
believes that the inventory aspect of the material control and 
accounting program could be met by controlling access to the 
subsurface, in conjunction with the use of Material Status Reports and 
the requirements in 10 CFR 63.71(b) for a record of movement of wastes 
within the geologic repository operations area.

[[Page 45090]]

    Response. DOE has the flexibility to demonstrate appropriate 
techniques for meeting material control and accounting requirements. 
The statement addressing storage of emplaced waste has been removed.

3.4 Physical Protection

    Issue 1: How would sensitive physical security plan information be 
protected?
    Comment. Numerous commenters expressed concern about the level of 
protection from public access that would be provided for Yucca Mountain 
physical protection plans, programs, and procedures.
    Response. Yucca Mountain physical protection plan information 
submitted to NRC staff for review and approval would be handled as 
Safeguards Information. Safeguards Information is protected from 
unauthorized disclosure in accordance with NRC regulations at 10 CFR 
73.21. Access would be limited to those persons with an established 
``need to know.''
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.
    Issue 2: Will NRC staff require a physical protection plan to be 
submitted with the license application?
    Comment. Numerous comments were received regarding whether a 
physical protection plan must be submitted with a license application. 
The commenters were concerned that there would not be adequate 
information in the plan and that the plan should be a complete and 
comprehensive document at the time of application submission.
    Response. Pursuant to 10 CFR 63.21(b)(3), DOE must submit ``A 
description of the detailed security measures for physical protection 
of high-level radioactive waste in accordance with section 73.51 of 
this chapter. This plan must include the design for physical 
protection, the licensee's safeguards contingency plan, and security 
organization personnel training and qualification plan. The plan must 
list tests, inspections, audits, and other means to be used to 
demonstrate compliance with such requirements.'' The applicant must be 
knowledgeable as to the requirements in 10 CFR 73.51 and must design 
the requirements into the facility during the engineering and design 
phase of the project. After the issuance of a construction 
authorization, the applicant would submit a baseline physical 
protection plan for technical review to enable the NRC staff to 
determine whether the requirements of 10 CFR 73.51 are met. Revisions 
to the physical protection plan will be submitted for technical review 
as needed should requirements or design specifications warrant a change 
in security methods and procedures.
    Modifications were made to the Yucca Mountain Review Plan to 
clarify the requirements for physical protection information.
    Issue 3: Are physical protection requirements appropriately 
reflected in the Yucca Mountain Review Plan?
    Comment. One commenter stated that the draft Yucca Mountain Review 
Plan sets forth physical protection requirements beyond those required 
by regulations. For example, 10 CFR 73.51(d)(4) requires daily random 
patrols for the protected area, but the draft Yucca Mountain Review 
Plan adds that a minimum of two patrols per security duty work shift 
should be conducted, unless the facility is in a remote area where more 
patrols may be necessary. Also, 10 CFR 73.51(d)(8) requires redundant 
communications capability, but the draft Yucca Mountain Review Plan 
adds a requirement that diverse systems should be used to ensure 
communications. In addition, the commenter recommends that the Yucca 
Mountain Review Plan simply state that DOE should commit to 
implementing the requirements of 10 CFR 73.51.
    Response. The Yucca Mountain Review Plan is a guidance document and 
cannot impose regulatory requirements. The Yucca Mountain Review Plan 
has been revised consistent with the requirements in 10 CFR 73.51.
    Issue 4: Should the Yucca Mountain Review Plan indicate that a 
designated response force could be used for security response?
    Comment. One commenter suggested that for consistency with 
regulations, the Yucca Mountain Review Plan should indicate that DOE 
may use a designated response force rather than a local law enforcement 
authority in response to physical security threat.
    Response. The Yucca Mountain Review Plan was modified to allow use 
of a designated response force, consistent with 10 CFR part 73.
    Issue 5: Does the Yucca Mountain Review Plan include realistic 
measures for verifying the effectiveness of the physical protection 
system?
    Comment. One commenter noted that the draft Yucca Mountain Review 
Plan statement in Section 3.5, ``Physical Protection Plan,'' that 
verification of the physical protection system should be conducted on-
site by the reviewer before plan approval should be deleted. The 
commenter noted that on-site verifications cannot be performed at the 
construction authorization stage and that this statement was 
inconsistent with other Yucca Mountain Review Plan statements that 
address only how the system will be designed, tested, and maintained.
    Response. The Yucca Mountain Review Plan was modified to remove the 
statement that on-site verification of the physical protection system 
was required before plan approval at the construction authorization 
stage.

4 Preclosure Period

4.1 Preclosure Operations

    Issue 1: What procedures will be used to control processes and 
event sequences during the operational phase of a repository?
    Comment. One commenter questioned control of processes and events 
that might occur during operations at a repository. The commenter asked 
for details of procedures that would be implemented in specific cases.
    Response. As is the case for other facilities regulated by NRC, 
operations related to safety or waste isolation must be performed using 
formal procedures. These procedures must address routine operations as 
well as emergencies. At a high-level waste repository, the procedures 
would also reflect the results of the preclosure safety analysis, to 
the extent applicable, which includes hazards identification, 
consequence evaluation, and risk assessment.
    Operating procedures would be evaluated before approval for receipt 
and possession of waste and would continue to be evaluated under the 
NRC inspection program that would be in place during the entire 
operational period of a repository.
    No changes were made to the Yucca Mountain Review Plan as a result 
of this comment.
    Issue 2: What are specific operating limits, parameters, or design 
criteria for the repository preclosure period?
    Comment. Commenters asked questions relating to specific operating 
limits, parameters, or design criteria for the operating period of a 
repository. Commenters also asked how NRC could evaluate the adequacy 
of a preclosure safety analysis if the design contained in the license 
application was not final.
    Response. Specific operating limits, parameters, and design 
criteria are not included in the Yucca Mountain Review Plan. DOE must 
define these parameters. The review methods and acceptance criteria in 
the Yucca Mountain Review Plan are flexible rather than prescriptive 
because the regulations at 10 CFR part 63 are risk-informed and 
performance-based.
    Pursuant to 10 CFR 63.21, the application must be as complete as 
possible in the light of information that

[[Page 45091]]

is reasonably available at the time of docketing. The regulations also 
require that DOE update the application to permit a timely review 
before the issuance of a license. These requirements also apply to the 
repository design.
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.
    Issue 3: What is the meaning of the term ``operational period''?
    Comment. One commenter asked for a definition of the term 
``operational period'' as used in Section 4.1.1.1, ``Site Description 
as It Pertains to Preclosure Safety Analysis,'' of the draft Yucca 
Mountain Review Plan. The commenter asked whether the term includes 
emplacement only or also post-emplacement performance monitoring.
    Response. A definition of the term ``operational period'' is found 
in 10 CFR 63.102(c), which states:

    * * * A period of operations follows the Commission's issuance 
of a license. The period of operations includes the time during 
which emplacement of waste occurs; any subsequent period before 
permanent closure during which the emplaced wastes are retrievable; 
and permanent closure, which includes sealing openings to the 
repository. Permanent closure represents the end of the performance 
confirmation program; final backfilling of the underground facility, 
if appropriate; and the sealing of shafts, ramps, and boreholes.

    Since this definition is included in 10 CFR part 63, no changes 
were made to the Yucca Mountain Review Plan.

4.2 Waste Retrieval Operations

    Issue 1: Does the Yucca Mountain Review Plan adequately address 
waste retrieval operations?
    Comment. Commenters raised questions regarding waste retrieval. One 
commenter asked for: (i) Any assumptions associated with waste 
retrieval; (ii) the time frame after closure for retrieval; and (iii) 
the number of years after closure during which it would be possible to 
retrieve waste. The same commenter stated that once waste retrieval 
criteria are established, they must not be watered down. A commenter 
stated that a ``high-speed, fast and dirty'' retrieval procedure should 
be established to respond to sudden, catastrophic events. Other 
commenters stated that the Yucca Mountain Review Plan should require 
DOE to physically show it can remotely emplace and retrieve disposal 
canisters.
    Response. The Commission has previously addressed issues related to 
retrievability of waste from a high-level waste repository at Yucca 
Mountain (66 FR 55743, November 2, 2001) and indicated that a physical 
demonstration of retrievability would not be necessary for a 
construction authorization.

    Some commenters were concerned that NRC's proposed regulations 
required DOE to submit plans for retrievability, but did not require 
an actual demonstration that the plans were feasible. Some 
commenters suggested that the NRC should require DOE to demonstrate 
the feasibility of its retrieval plans. * * * If necessary to 
protect public health and safety, waste package retrieval in a deep 
geologic repository would be a first-of-a-kind endeavor with unique 
engineering and geotechnical challenges. The Commission recognizes 
that the retrieval operation would be an unusual event, and may be 
an involved and expensive operation (U.S. Nuclear Regulatory 
Commission, ``Staff Analysis of Public Comments on Proposed Rule10 
CFR part 60, `Disposal of High-Level Radioactive Wastes in Geologic 
Repositories,' '' Office of Nuclear Regulatory Research, NUREG-0804, 
December 1983; p. 11). As such, DOE can expect that its plans and 
procedures in this area will receive extensive, detailed review by 
the NRC staff as part of any construction authorization review. The 
feasibility and reasonableness of DOE's retrieval plans will be 
reviewed by the NRC staff at the time of the license application 
submittal. * * * However, the Commission does not envision that DOE 
will need to build full-scale prototypes of its retrieval systems to 
demonstrate that its retrieval plans are practicable at the time of 
construction authorization. Rather, DOE needs to design (and build) 
the repository in such a way that the retrieval option is not 
rendered impractical or impossible.

    With regard to the time frame for waste retrieval, the Commission 
stated (66 FR 55743, November 2, 2001):

    Some commenters expressed a belief that the period of waste 
package retrieval could be accomplished beyond 50 years, and there 
should be flexibility for extending the period of retrievability to 
longer time periods. One commenter suggested that the repository 
should be monitored to determine if there will be problems (e.g., 
too high a temperature, too much water inflow) that would require 
the waste to be retrieved. The same commenter suggested that 
stewardship of the waste be maintained (indefinitely) so that waste 
could be made available for future energy needs. * * * The 50-year 
limit on waste retrieval operations was adopted from the generic 
requirements found at Part 60. At the time Part 60 was first 
promulgated, the Commission solicited comment on what was then a 
proposed 100-year retrieval period (46 FR 35282; July 8, 1981). 
However, after an analysis of public comments, it was determined 
that the Commission's earlier proposal was excessive, and the 
shorter 50-year period was decided [up]on (U.S. Nuclear Regulatory 
Commission, ``Staff Analysis of Public Comments on Proposed Rule 10 
CFR part 60, `Disposal of High-Level Radioactive Wastes in Geologic 
Repositories,' '' Office of Nuclear Regulatory Research, NUREG-0804, 
December 1983). In specifying this time period, the Commission noted 
that the 50-year period was ``provisional'' and subject to possible 
modification (i.e., longer periods) in light of both the planned 
waste emplacement schedule and completion of the performance 
confirmation program and a review of those results. After 50 years 
of waste emplacement operations and performance confirmation, the 
Commission previously reasoned, it is likely that significant 
technical uncertainties will be resolved, thereby providing greater 
assurance that the performance objectives will be met. It should be 
noted that DOE is free to design the repository for retrieval 
periods greater than 50 years. In fact, the Commission understands 
that DOE is contemplating working designs that may provide for a 
retrieval period of up to 300 years. * * * Thus, as recommended in 
this comment, allowance for longer waste retrieval periods greater 
than 50 years is permitted under the regulation. As for longer 
retrieval periods that would permit the recovery of the high-level 
waste as a potential resource, the Commission has previously noted 
that its retrieval provision is not intended to facilitate recovery. 
Waste retrieval is intended to be an unusual event only to be 
undertaken to protect public health and safety.

    The Commission also generally addressed assumptions about waste 
retrieval (66 FR 55743, November 2, 2001):

    One commenter inquired as to the disposition of the waste if it 
is determined that retrieval is necessary. * * * Part 63 does not 
specifically address any required actions for the handling of 
retrieved waste from an operating geologic repository, but * * * 
Section 63.21(c)(7) [in the final rule] does require that DOE's 
Safety Analysis Report include a description of its plans for the 
alternate storage of the radioactive wastes, should retrieval be 
necessary. Retrieved waste would need to be controlled in compliance 
with applicable regulations at the time of retrieval.

    DOE must justify in a license application any assumptions used in 
its plans for waste retrieval. DOE must demonstrate that the repository 
is designed to allow retrieval in a manner that would protect health 
and safety as well as keeping radiation exposures as low as is 
reasonably achievable. Neither the Nuclear Waste Policy Act nor 10 CFR 
part 63 include a requirement for an expedited retrieval in case of 
sudden catastrophic events, however, NRC would require actions 
necessary to protect health and safety.
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.
    Issue 2: Does the Yucca Mountain Review Plan adequately address 
plans for alternate storage of waste?
    Comment. One commenter stated that DOE did not address alternate 
storage of waste in the Yucca Mountain Final Environmental Impact 
Statement. The commenter asked whether, by including

[[Page 45092]]

alternative storage in the Yucca Mountain Review Plan, NRC is inferring 
its expectation that a license application for a high-level waste 
repository at Yucca Mountain would cover alternate storage. The 
commenter noted the Yucca Mountain Review Plan is specific about 
assumed elements of the repository system, but does not describe such 
elements earlier in the review plan. The commenter suggested that the 
Yucca Mountain Review Plan be revised to include NRC expectations of 
the specific elements of the repository system that would be the 
subject of a license application.
    Response. A review of DOE plans for alternate storage of waste is 
included within the Yucca Mountain Review Plan because these plans are 
specifically required by 10 CFR 63.21(c)(7), which requires that DOE's 
Safety Analysis Report include a description of plans for the alternate 
storage of the radioactive wastes should retrieval be necessary. 
Retrieved waste would need to be controlled in compliance with 
applicable regulations at the time of retrieval. Beyond requiring such 
plans, the regulations have no specific requirements on this subject. 
Accordingly, the three components of the related Review Method and 
Acceptance Criterion for reviewing plans for alternative storage of 
waste (i.e., the physical location and boundary of the proposed 
alternate storage area are adequately defined; the proposed alternate 
storage area is sufficient to hold the waste; and the area is adequate 
to protect workers and the public during the transport of the waste to 
alternate storage) are sufficient.
    No changes have been made to the Yucca Mountain Review Plan in 
response to this comment.

4.3 Criticality

    Issue: What equipment would be available for addressing criticality 
accidents?
    Comment. One commenter asked what equipment would be available in a 
repository for high-level waste at Yucca Mountain to deal with 
criticality accidents.
    Response. Pursuant to 10 CFR 63.112(e)(6), DOE must address the 
potential for criticality accidents during the preclosure period of 
operations. After any criticality risks have been established, NRC will 
evaluate whether equipment should be provided to deal with such 
accidents.
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.

4.4 Preclosure Safety Analysis

    Issue 1: Is the definition of probability associated with Category 
2 event sequences adequate?
    Comment. One commenter stated that the use of one chance in 10,000 
over 300 years is illogical and non-conservative considering the 
trillions of curies that would be present in a high-level waste 
repository at Yucca Mountain. The commenter stated that if the criteria 
for excluding events from Category 2 are based on opinion and 
speculation, the information could be biased, erroneous, or misleading. 
The commenter stated that the criteria for Category 2 must be broadened 
to overcome these inadequacies and that NRC staff needs to be careful 
when excluding catastrophic events from Category 2.
    Response. A licensing review for a high-level waste repository at 
Yucca Mountain will be conducted in an objective manner to determine 
whether information is accurate and regulatory standards are met. Error 
in analyses will be addressed in NRC staff's review of analysis, 
design, and operations.
    The Commission addressed the Category 2 criteria in the ``Statement 
of Considerations'' for 10 CFR part 63 (66 FR 55741-55742, November 2, 
2001) as follows.

    The Commission agrees that the basis for determining the 
probability for design basis events and what initiating events 
should be considered in the safety analysis should be clarified. * * 
* the Commission has revised the rule for clarity as follows: (1) A 
new term ``initiating event'' is defined; (2) the present term 
``design basis event'' is replaced with a new term ``event 
sequence''; and (3) Section 63.102(f) is revised to clarify the 
scope of the preclosure safety analysis and the requirements for the 
inclusion or exclusion of specific, naturally-occurring, and human-
induced hazards in the safety analysis.
    Initiating events are to be considered for inclusion in the 
preclosure safety analysis for determining event sequences only if 
they are reasonable (i.e., based on the characteristics of the 
geologic setting and the human environment, and are consistent with 
precedents adopted for nuclear facilities with comparable or higher 
risks to workers and the public).
* * * * *
    Within the context of the ISA (PSA), DOE is expected to identify 
the relevant initiating events and event sequences and estimate 
potential radiologic exposures. Part 63 provides flexibility to DOE 
in selecting an appropriate approach for estimating doses, including 
selection of pertinent exposure pathways and the degree of 
conservatism or realism to include in the analysis. DOE will need to 
defend and support whatever approach it selects for identifying 
initiating events and analyzing event sequences. In the selection of 
a particular approach, DOE will need to consider the uncertainties 
and limitations associated with a particular method of analysis and 
data.

    Regulation of nuclear facilities requires realistic or reasonably 
conservative approaches that take into account importance to safety, 
technical complexity, and the degree and nature of any associated 
uncertainty. These concepts underlie the ``reasonable assurance'' and 
``reasonable expectation'' determinations that would be applied in 
reviewing the DOE license application. However, the Yucca Mountain 
Review Plan recognizes that, consistent with a risk-informed, 
performance-based approach, DOE has the flexibility to select an 
approach that could include reasonably conservative analyses.
    The Commission addressed the issue of conservatism in the 
``Statement of Considerations'' for 10 CFR part 63 (66 FR 55739-55740, 
November 2, 2001).

    Confidence that DOE has, or has not, demonstrated compliance 
with EPA's standards is the essence of NRC's licensing process * * 
*. The Commission does not believe that NRC's use of ``reasonable 
assurance,'' as a basis for judging compliance, causes focus on 
extreme values (i.e., tails of distributions) for representing the 
performance of a Yucca Mountain repository. Further * * * if the 
Commission is called on to make a decision * * * the Commission will 
consider the full record before it. That record will include many 
factors in addition to whether the site and design comply with the 
performance objectives (both preclosure and postclosure performance 
standards) * * *. The Commission could consider the QA program, 
personnel training program, emergency plan and operating procedures, 
among others, in order to determine whether it has confidence that 
there is no unreasonable risk to the health and safety of the 
public.
    The Commission is satisfied that a standard of ``reasonable 
expectation'' allows it the necessary flexibility to account for 
inherently greater uncertainties in making long-term projections of 
a repository's performance. The Commission agrees with EPA and 
others that it is important to not exclude important parameters from 
assessments and analyses simply because they are difficult to 
precisely quantify to a high degree of confidence * * *. The 
Commission expects that the required analyses of postclosure 
performance will focus on the full range of defensible and 
reasonable parameter distributions, and that they should not be 
constrained only to extreme physical situations and parameter 
values. For other determinations regarding compliance of the 
repository with preclosure objectives, the Commission will retain a 
standard of ``reasonable assurance'' consistent with its practice 
for other licensed operating facilities subject to active licensee 
oversight and control.

    No changes were made to the Yucca Mountain Review Plan as a result 
of this comment.

[[Page 45093]]

    Issue 2: Has an evaluation of the characteristics of the controlled 
area been included in the Yucca Mountain Review Plan?
    Comment. One commenter stated that no mention could be found in the 
Yucca Mountain Review Plan of the size and location of the controlled 
area. The commenter argued that specification of the controlled area is 
a key factor in the licensing process and must be addressed in a 
license application and in the NRC review.
    Response. The controlled area is defined by 10 CFR part 63.302. 
This is addressed in Section 4.1.1.1, ``Site Description as It Pertains 
to Preclosure Safety Analysis'', of the draft Yucca Mountain Review 
Plan.
    The Yucca Mountain Review Plan was modified to include reference to 
the controlled area, where appropriate.
    Issue 3: Does the Yucca Mountain Review Plan adequately evaluate 
radiation exposures during the preclosure operations at a potential 
high-level waste repository at Yucca Mountain?
    Comment. One commenter noted that the Yucca Mountain Final 
Environmental Impact Statement indicated that the predominant 
radiological impacts during the preclosure period would be from radon 
releases. The commenter stated that the Yucca Mountain Review Plan does 
not address radiological safety associated with potential radon 
releases and associated worker exposures. The commenter suggests that 
these potential safety issues be added to the review.
    Response. Safety issues related to radiation exposure, including 
radon, during the preclosure period are covered in the Yucca Mountain 
Review Plan. DOE is required by 10 CFR 63.111 to use a preclosure 
safety analysis to evaluate compliance with performance objectives for 
the preclosure period. A preclosure safety analysis proceeds from an 
identification of hazards, events, and event sequences to assessments 
of consequence and risk. This process includes an evaluation of 
radiation hazards and risks. The Yucca Mountain Review Plan reflects a 
thorough review of DOE's preclosure safety analysis as set forth in 
Section 4.1.1, ``Preclosure Safety Analysis,'' of the draft Yucca 
Mountain Review Plan.
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.

4.5 Structures, Systems, and Components of the Subsurface Facility

    Issue: Will the design, construction, control, and quality 
assurance of the waste canisters be adequate?
    Comment. Commenters expressed a number of concerns about the 
standards to be used for waste canisters. One commenter raised a number 
of concerns regarding how the quality assurance requirements would be 
met for structures, systems, and components important to safety, safety 
controls, and measures to ensure availability of safety systems.
    Response. If the waste canisters are important both to safety and 
to waste isolation, their design, manufacture, and performance would be 
subject to NRC's quality assurance requirements. These requirements are 
defined in 10 CFR part 63, subpart G, and are consistent with NRC's 
quality assurance standards for other nuclear facilities. DOE must 
satisfy these quality assurance requirements by performing planned and 
systematic actions necessary to provide confidence that the geologic 
repository and its structures, systems, and components will perform 
satisfactorily.
    The regulations require that quality assurance requirement for 
systems, structures, and components be evaluated during a licensing 
review for a high-level waste repository at Yucca Mountain. NRC staff 
would use the quality assurance requirements in 10 CFR part 63, subpart 
G to determine whether the program was adequate.
    No changes were made to the Yucca Mountain Review Plan as a result 
of this comment.

4.6 Alternative Designs

    Issue: Should alternative designs be examined in a license 
application for a high-level waste repository at Yucca Mountain?
    Comment. One commenter was concerned that nowhere in the Yucca 
Mountain Review Plan is there clear direction to NRC staff reviewers to 
ensure that DOE, in its application and supporting documents, has 
adequately considered alternative repository designs. The commenter 
noted that the subject is touched on in draft Yucca Mountain Review 
Plan Section 4.3, ``Research and Development Program to Resolve Safety 
Questions,'' however, this section does not specifically address 
alternative designs, outside of the scope of the research and 
development program, to resolve safety questions.
    The commenter noted that because DOE's design could be contested 
during licensing, and Nye County, Nevada, the Nuclear Waste Technical 
Review Board, and others believe that a cooler repository would reduce 
uncertainties in long-term performance, NRC staff reviewers should take 
steps to ensure that the DOE license application is complete and of 
high quality on that issue. The commenter concluded that a thorough and 
comprehensive test of DOE's design, specifically with respect to 
reducing thermal effects and the potential for water to contact the 
waste packages, should be a minimum test of the adequacy and 
completeness of a DOE license application for a high-level waste 
repository at Yucca Mountain.
    Response. The question as to whether DOE must consider alternative 
repository designs was previously addressed by the Commission in its 
``Statement of Considerations'' for 10 CFR part 63 (66 FR 55748-55749, 
November 2, 2001) as follows:

    The Commission agrees with the comments and has removed [this 
requirement to evaluate alternative designs] from the regulations. 
The NRC review should focus on the safety aspects of DOE's proposed 
approach. DOE should only be required to propose alternatives from 
its proposed approach in areas where the NRC review determines DOE's 
approach is deficient. When developing proposed part 63, the NRC 
staff adopted this requirement from 10 CFR part 60, the existing 
generic NRC high-level waste disposal regulation, which contains a 
similar requirement in 10 CFR 60.21(c)(1)(ii)(D). At the time of the 
issuance of part 60, DOE objected to this specific requirement with 
basically the same argument presented for Part 63. In the 
``Statement of Considerations'' for part 60 (published in [the] 
Federal Register [notice] on June 21, 1983; 48 FR 28194), the 
Commission justified the requirement by stating ``If the Commission 
finds, on the basis of its review, that the adoption of some 
alternative design feature would significantly increase its 
confidence that the performance objectives would be satisfied, and 
that the costs of such an approach are commensurate with the 
benefits, it should not hesitate to insist that the alternative be 
adopted.''
    The decision to require DOE to submit alternatives for certain 
site design features was a discretionary action on the part of the 
Commission as nothing (in either the Atomic Energy Act of 1954, as 
amended, or the Nuclear Waste Policy Act of 1982, as amended) 
required the Commission to obtain information on alternative designs 
at the site level. At the time part 60 was initially published 
(1983), the Commission implemented an appropriate regulatory 
framework for a generic program facing many uncertainties. Multiple 
sites with very different geological settings were under 
consideration. The NRC's generic HLW regulations had to address the 
resolution of a large number of technical issues in the relative 
short licensing review period established by the Nuclear Waste 
Policy Act of 1982. With all the uncertainties in the program, the 
Commission believed it was important to require design alternatives 
be submitted with the application to increase the probability of NRC 
approval of the license application within the three-year schedule 
mandated by Congress.

[[Page 45094]]

    The Commission has revisited the decision to require submission 
of alternative designs. Specifically, the Commission no longer 
believes this information should be submitted with a license 
application and, accordingly, has removed this requirement. To 
protect public health and safety and the common defense and 
security, which is the NRC's mandate under the Atomic Energy Act of 
1954 as amended, the Commission will closely scrutinize the design 
proposed by DOE. Consistent with this mandate, the new part 63 is 
designed to be a risk-informed, performance-based regulation which 
establishes overall repository performance objectives. DOE must 
demonstrate that the repository meets the performance objectives. 
The NRC review is an audit of DOE's demonstration to determine if we 
agree that the performance objectives have been met. If the NRC 
believes that the site does not meet the performance objectives 
within uncertainties addressed in the analysis, then it is DOE's 
responsibility to either defend its current design or propose an 
alternative design that can meet the NRC acceptance criteria.

    Because thermal effects and the potential for water to contact the 
waste packages may be important considerations in the design of a 
potential high-level waste repository at Yucca Mountain, DOE would need 
to provide an assessment of the thermal operating range for a design in 
its license application. The NRC staff will determine, before 
docketing, whether the information provided is sufficient for NRC to 
conduct its review.
    No changes have been made to the Yucca Mountain Review Plan in 
response to this comment.

5 Postclosure Period

5.1 Consistency With Postclosure Requirements in 10 CFR Part 63

    Issue 1: Should the text in the postclosure sections of the Yucca 
Mountain Review Plan be modified to more closely reflect the language 
of 10 CFR part 63?
    Comment. Several commenters identified places where the text of the 
Yucca Mountain Review Plan could be revised to better reflect the 
language of postclosure requirements in 10 CFR part 63, subpart L. One 
commenter noted several places where text should be modified to refer 
to the dose to the reasonably maximally exposed individual rather than 
more general terms such as average annual dose. Another commenter noted 
incorrect citations in Section 4.2.1.3.14.4 of the draft Yucca Mountain 
Review Plan. Additional comments indicated several locations where the 
draft Yucca Mountain Review Plan text on postclosure public health and 
environmental protection (Section 4.2.1.4) could be modified to be more 
consistent with the requirements of 10 CFR part 63, subpart L.
    Response. The text in the Yucca Mountain Review Plan should 
accurately reflect the language and intent of 10 CFR part 63.
    The Yucca Mountain Review Plan has been modified, as appropriate, 
to provide correct references to the postclosure requirements in 10 CFR 
part 63. Text citations for the required characteristics of the 
reference biosphere [10 CFR 63.305(a-d)] have been corrected as needed. 
Also, text in Section 4.2.1.4 of the draft Yucca Mountain Review Plan 
has been modified to improve consistency between the review methods and 
acceptance criteria and the postclosure public health and environmental 
standards specified in 10 CFR part 63, subpart L.
    Issue 2: Is the description of the representative volume consistent 
with NRC regulations in 10 CFR 63.312?
    Comment. Several commenters stated that the use of a representative 
volumes of groundwater in Sections 4.2.1.3.12, ``Representative 
Volume,'' and 4.2.1.4.3, ``Analysis of Repository Performance that 
Demonstrates Compliance with Separate Ground-Water Protection 
Standards,'' of the draft Yucca Mountain Review Plan is not consistent 
with U.S. Environmental Protection Agency and NRC implementation 
regulations at 10 CFR part 63.
    Response. Section 4.2.1.3.12 of the draft Yucca Mountain Review 
Plan confuses the concept of water demand for the postclosure 
individual protection standard with the concept of the representative 
volume of water for the postclosure ground-water protection standard.
    The postclosure individual protection standard at 10 CFR 63.111 
requires that DOE demonstrate the reasonably maximally exposed 
individual would receive an annual cumulative effective dose equivalent 
of no more than 150 microsieverts. Under 10 CFR 63.312(c), the 
reasonably maximally exposed individual will use ``well water with 
concentrations of radionuclides based on an annual water demand of 
3,000 acre-feet.'' 10 CFR part 63 also mandates use of the 
representative volume of water concept in demonstrating compliance with 
the separate ground-water protection standards. The definition of the 
representative volume of water also specifies a volume of 3,000 acre-
feet per year; however, the applicant must also define the dimensions 
of this volume using one of two specified methods.
    The Yucca Mountain Review Plan has been modified to clarify these 
requirements.
    Issue 3: Are the review methods and acceptance criteria for 
evaluating the demonstration of compliance with the human-intrusion 
standard adequate?
    Comment. One commenter stated that the review methods and 
acceptance criteria for evaluating the demonstration of compliance with 
the human-intrusion standard are not complete or consistent with NRC 
regulations at 10 CFR part 63. For example, the commenter expressed 
concern that the review methods in Section 4.2.1.4.2.1, ``Demonstration 
of Compliance with the Human Intrusion Standard,'' of the draft Yucca 
Mountain Review Plan indicate that the review need only confirm that 
performance assessment for human intrusion is performed during the 
10,000-year regulatory time period. The commenter also noted that, if 
the projected doses from an intrusion reach the reasonably maximally 
exposed individual after the 10,000-year regulatory time period, 10 CFR 
63.321 requires DOE to include the results of the analysis and its 
basis in the Yucca Mountain environmental impact statement. The 
commenter also stated that the draft Yucca Mountain Review Plan does 
not call for DOE to identify the specific mechanism for radionuclide 
transport from a breached waste package to the saturated zone.
    Response. The review methods in Section 4.2.1.4.2.2 of the draft 
Yucca Mountain Review Plan have been modified to clarify that the 
human-intrusion performance assessment should be conducted regardless 
of the estimated time of the intrusion. The review methods have also 
been modified to note that 10 CFR 63.321 requires that exposures to the 
reasonably maximally exposed individual that might result from human 
intrusion and occur after the 10,000-year regulatory time period are to 
be included in the Yucca Mountain environmental impact statement. In 
addition, the regulations at 10 CFR 63.322 require that DOE consider 
the transport of radionuclides in ground water through the borehole to 
the saturated zone. The Yucca Mountain Review Plan, however, is 
guidance for NRC staff safety review and will not be used to review 
DOE's environmental impact statement. Environmental reviews would be 
performed according to the requirements of 10 CFR 51.109, and 
applicable guidance.
    The review methods in Section 4.2.1.4.2.2 of the draft Yucca 
Mountain Review Plan have been modified for clarification.

[[Page 45095]]

5.2 Multiple Barriers

    Issue 1: Will the Yucca Mountain Review Plan consider limitations 
of each barrier's capability?
    Comments. Commenters argued that numerous unresolved questions 
remain with respect to the engineered and natural barriers (e.g., 
durability of the waste package, amount of water flowing into 
repository drifts) that raise concerns regarding how the Yucca Mountain 
Review Plan considers the limitations in barrier capabilities. 
Commenters asked a number of questions regarding how specific systems, 
subsystems, and components of the repository would perform.
    Response. In accordance with 10 CFR 63.115, NRC staff's review of 
the capability of each barrier relied upon by DOE will include 
consideration of uncertainty in the behavior of the barriers. 
Additionally, the barrier capability is to be described in terms of the 
approaches used in the performance assessment, which include potential 
limitations in barrier capabilities, through consideration of 
uncertainty in parameters; alternative conceptual models; and 
degradation, deterioration, and alteration processes of the engineered 
barriers. Each of the model abstractions (i.e., degradation of 
engineered barriers, flow paths in the saturated zone) in the Yucca 
Mountain Review Plan includes consideration of potential limitations in 
the representation of the repository barriers. The Yucca Mountain 
Review Plan supports a detailed review of repository barriers and 
provides understanding of the intended function of each of the barriers 
and of the potential limitations regarding individual barrier 
performance. The concerns noted in the comment must be adequately 
addressed in a DOE license application for a high-level waste 
repository at Yucca Mountain.
    Section 4.2.1.1, ``System Description and Demonstration of Multiple 
Barriers,'' of the draft Yucca Mountain Review Plan indicates that: (i) 
There are no quantitative limits placed on individual barriers or 
categories of barriers; and (ii) the intent of the review is to 
understand the capability of each barrier to perform its intended 
function and the relationship of that barrier's role to limiting 
radiological exposure in the context of the overall performance 
assessment.
    Issue 2: Does the Yucca Mountain Review Plan appropriately describe 
potential barrier functions?
    Comment. The commenter recommended that the exact wording from the 
definition of barrier in 10 CFR part 63 (that is, prevents or 
substantially reduces the rate of movement of water or radionuclides 
from the Yucca Mountain repository to the accessible environment, or 
prevents the release or substantially reduces the release rate of 
radionuclides from the waste) be used to describe the potential 
functions of the barriers in Sections 4.2.1.1.1, ``System Description 
and Demonstration of Multiple Barriers,'' of the draft Yucca Mountain 
Review Plan.
    Response. Use of the exact wording from the definition of barrier 
in 10 CFR 63.2 to describe the potential functions of the barriers in 
the Yucca Mountain Review Plan is appropriate and the Yucca Mountain 
Review Plan has been modified accordingly.
    Issue 3: Should the Yucca Mountain Review Plan specify that a 
specific natural or engineered barrier be the primary barrier for the 
repository?
    Comment. Some commenters were concerned that current expectations 
for the waste package to be corrosion-resistant for more than 10,000 
years reduce the requirement that the repository include natural or 
geologic barriers. One commenter requested that the repository be 
required to be substantially geologic. Another commenter asked that 
Section 4.2.1.1, ``System Description and Demonstration of Multiple 
Barriers,'' of the draft Yucca Mountain Review Plan clarify that 
neither natural nor engineered barriers need be the primary barriers 
for containing radionuclides, reflecting that overall performance of 
the repository is important, rather than subsystem requirements.
    Response. The regulations at 10 CFR 63.115 require DOE to identify 
the barriers of the repository system, describe the capabilities of the 
barriers, and provide the technical basis for each barrier's 
capability. The Yucca Mountain Review Plan addresses this requirement.
    No changes have been made to the Yucca Mountain Review Plan in 
response to this comment.

5.3 Screening Features, Events, and Processes

    Issue 1: How will NRC determine whether the appropriate features, 
events, and processes have been included in a postclosure performance 
assessment?
    Comment. Several commenters expressed concern whether DOE would 
provide a complete evaluation of features, events, and processes, in 
developing its postclosure performance assessment (similar in concept 
to the Category 1 and 2 initiating events in the preclosure section of 
the Yucca Mountain Review Plan). One commenter proposed establishing a 
Category 3 that would encompass natural and man-made events and stated 
that the total system performance assessment should include an analysis 
of climate changes over 10,000 years. Additional comments on specific 
potential disruptive scenarios included were provided.
    Several commenters cited the current DOE design plans calling for 
titanium drip shields as evidence that the Yucca Mountain environment 
contains significant amounts of water, and expressed concern that this 
water and the geochemically oxidizing environment for the proposed 
repository would lead to corrosion of the waste packages. Commenters 
also expressed concern about the performance of Alloy C-22 and 
cladding, and requested specific technical information on engineered 
materials performance.
    Another commenter expressed concern that if the consequence of an 
event were high, it must be considered in the performance assessment, 
regardless of the probability of its occurrence. The same commenter 
took exception to the use of the term ``credible natural events,'' 
arguing that this was an artificial means of removing disruptive events 
from further consideration for mitigation. One commenter asked whether 
microbial influenced events were being evaluated.
    Response. Consideration of features, events, and processes, 
especially those with potentially adverse effects, is a key part of the 
performance assessment process. A number of features, events, and 
processes have been or are being considered relevant to the performance 
of the proposed repository at Yucca Mountain. DOE has the 
responsibility to prepare the postclosure performance assessment and 
demonstrate compliance with the postclosure performance objectives of 
10 CFR 63.113. In meeting the performance objectives, the regulations 
in 10 CFR 63.114 require DOE to consider pertinent features, events, 
and processes. As described in Section 4.2.1.2, ``Scenario Analysis and 
Event Probability,'' of the draft Yucca Mountain Review Plan, it is 
anticipated that DOE would screen an initial list of features, events, 
and processes that include the issues raised by the commenters. The 
purpose of the screening is for DOE to develop a final list that will 
be considered in detail in its postclosure performance assessment. DOE 
must provide a technical basis for the inclusion or exclusion of 
features, events, and processes from the performance assessment. As 
defined in 10 CFR 63.114(d), one of the screening

[[Page 45096]]

criteria is to establish as credible only those events with a 
probability of occurrence of one chance in 10,000 per year over 10,000 
years. As discussed in Section 4.2.1.2 of the draft Yucca Mountain 
Review Plan, DOE must provide the technical basis for screening events 
based on probability.
    Based on prelicensing exchanges and on earlier iterative 
performance assessments provided by DOE, NRC anticipates that DOE would 
include many of the features, events, and processes identified by the 
commenters (e.g., climate change, volcanic disruption, seismic 
activity, glaciation, groundwater transport) in its performance 
assessment. If other features, events, and processes identified by the 
commenter are excluded from the postclosure performance assessment, DOE 
must include the technical bases for the exclusions as expressed by 10 
CFR 63.114(e). Part of this technical basis must include site 
characterization information such as groundwater chemistry, location of 
faults and igneous features, and geomorphology.
    To support the postclosure performance assessment, DOE is required 
to submit data on the hydrology, geochemistry, and geology of the Yucca 
Mountain site by 10 CFR 63.114(a). Specific information of the type 
identified in several comments (groundwater temperature, fluoride 
concentration, C-22 alloy performance) is the responsibility of DOE. 
NRC staff will evaluate the adequacy of this information as part of a 
licensing review, using the review methods and acceptance criteria 
presented in the Yucca Mountain Review Plan.
    No changes were made to the Yucca Mountain Review Plan in response 
to these comments.
    Issue 2: Why do the review methods in the Yucca Mountain Review 
Plan specify time and extent of past patterns of natural events?
    Comment. A comment stated that review methods for probability 
models refer to site-specific information that NRC staff should 
consider during a review of a license application. The commenter argued 
that this information is too prescriptive and based on NRC judgements 
of what is important for probability models. The commenter asks for a 
more generalized discussion in Review Methods 2 and 3 of Section 
4.2.1.2.2, ``Identification of Events with Probabilities Greater Than 
10 -\8\ Per Year,'' of the draft Yucca Mountain Review Plan. The same 
commenter also expressed concern that the past patterns of natural 
events in the Yucca Mountain region provide overly prescriptive 
information for NRC staff review of probability models.
    Response. In using Acceptance Criterion 2 of Section 4.2.1.2.2, NRC 
staff would consider the past patterns of natural events in the Yucca 
Mountain region. This acceptance criterion is used considering the 
range of information that NRC staff may consider with respect to the 
timing and general extent of past events. Thus, Review Method 2 
provides general guidance regarding the timing (e.g., ``past igneous 
activity since about 12 million years'') and extent (e.g., ``within 
about 50 kilometers of the proposed repository site'') of past natural 
events to provide a basis for use of Acceptance Criterion 2. DOE is not 
restricted to these general definitions for past patterns of natural 
events and may provide any technical basis that it believes 
demonstrates compliance with the requirements of 10 CFR 63.114(a)(4).
    As noted in Acceptance Criterion 2, an appropriate technical basis 
for probability estimates would be based on past patterns of natural 
events in the Yucca Mountain region. Acceptable probability models 
would be based on past events in the Yucca Mountain region; however, 
these models may incorporate additional considerations, as deemed 
appropriate by DOE. These additional considerations would be reviewed 
by NRC staff in a licensing review.
    No changes were made to the Yucca Mountain Review Plan as a result 
of this comment.
    Issue 3: Why do the review methods call for use of independently 
developed probability models?
    Comment. A commenter stated that Section 4.2.1.2.2, 
``Identification of Events with Probabilities Greater Than 10 -\8\ Per 
Year,'' of the draft Yucca Mountain Review Plan, refers to the use of 
independently developed probability models. The commenter noted that 
more specific guidance to reviewers is needed for the use of 
independent probability models, and that use of independent models 
would bias NRC staff reviews.
    Response. In its licensing review, NRC staff considers information 
submitted by the license applicant and results of independent NRC staff 
analyses. The use of independent probability models enables NRC staff 
to focus on those areas that are most important to risk consistent with 
a risk-informed, performance-based approach.
    Guidance on the use of independent models in Review Method 3 of 
Section 4.2.1.2.2 has been modified.
    Issue 4: Is it appropriate to relate igneous activity to other 
geologic processes?
    Comment. One commenter asserted that igneous activity is 
incorrectly related to other geologic processes. The commenter also 
stated that the use of tectonic models in Acceptance Criterion 3 and 
Review Method 3 of Section 4.2.1.2.2, ``Identification of Events with 
Probabilities Greater Than 10 -\8\ Per Year,'' of the draft Yucca 
Mountain Review Plan is overly prescriptive and that the consideration 
of information from comparable volcanic systems outside the Yucca 
Mountain region in Review Method 4 of Section 4.2.1.2.2 also appears 
overly prescriptive.
    Response. Review Method 3 in Section 4.2.1.2.2 states ``Assess 
whether igneous-activity probability models are consistent with the 
range of tectonic models used to assess other geological processes, 
such as seismic source characterization, site geological models, and 
patterns of ground-water flow.'' This statement does not relate igneous 
activity to other geologic processes through tectonic processes. 
Rather, it instructs reviewers to evaluate the consistency between 
tectonic models used in igneous activity probability models with 
tectonic models used to evaluate other geologic processes. Consistent 
use of tectonic models for different, relevant geologic processes may 
provide support for probability models.
    Not all parameters used in a probabilistic volcanic hazard 
assessment for Yucca Mountain would necessarily need to consider 
information from comparable volcanic systems. Paragraph 2 of Review 
Method 4 of Section 4.2.1.2.2 has been rewritten to clarify this point.
    Issue 5: Does the Yucca Mountain Review Plan contain excessively 
prescriptive requirements with regard to the use of analog information 
to assess the effects of igneous activity on repository performance?
    Comment. The commenter argued that use of analog information ``to 
the extent possible'' as discussed in Acceptance Criterion 3 of Section 
4.2.1.2.2 is overly prescriptive and suggested use of analog 
information only ``to the extent appropriate.'' The same commenter also 
suggested changing requirements for the accuracy of probability models 
to avoid excess prescriptiveness.
    Response. DOE may submit any information it believes will satisfy 
the requirements of 10 CFR 63.114(a)(4). The use of information from 
analog volcanic fields, to the extent appropriate, could be used as a 
basis for model justification.
    The text of the Yucca Mountain Review Plan has been modified to

[[Page 45097]]

clarify that analog information should be used to the extent 
appropriate.

5.4 Model Abstraction

    Issue 1: What site characterization information would be included 
in the postclosure performance assessment?
    Comment. A number of commenters provided examples of features, 
events, and processes that they contended should be included in the 
postclosure performance assessment. These included general lists of 
information on characteristics of the geologic and hydrologic setting, 
an inventory of potential corrosives from waste canisters, and 
climatologic information. One commenter stated that the performance 
assessment should include types of indirect information that may 
indicate the occurrence of past natural disruptive events. The same 
commenter noted that the general description should include trends in 
seismic and volcanic activity, as well as a study of volcanically 
active regions in the Cascade Mountains, and should evaluate the 
possibilities of similar activity at Yucca Mountain.
    Response. DOE has the responsibility to prepare the postclosure 
performance assessment and demonstrate compliance with the performance 
objectives of 10 CFR 63.113. 10 CFR 63.114 requires DOE to provide a 
technical basis for the inclusion or exclusion of features, events, and 
processes in the performance assessment. This technical basis would 
include site characterization information.
    No changes were made to the Yucca Mountain Review Plan as a result 
of this comment.
    Issue 2: How would uncertainty be addressed in the model 
abstractions used in the postclosure performance assessment?
    Comment. A number of comments were provided on uncertainties 
related to the engineered barriers and natural system, and how these 
uncertainties would be addressed in the review of a postclosure 
performance assessment. One commenter expressed concern that there were 
inconsistencies in how the alternative conceptual models are to be used 
in evaluating uncertainty in the postclosure performance assessment. 
Another commenter asked how NRC would consider uncertainties in 
reviewing DOE's performance assessment and requested more detail on the 
role uncertainty would play in establishing priorities for the 
licensing decision. Another commenter noted concerns about the basis 
for performance assessment model abstractions expressed in letters from 
the Advisory Committee on Nuclear Waste to NRC Chairman Richard Meserve 
(September 28, 2001; and January 17, 2002).
    Response. Accounting for uncertainty in estimating repository 
performance is an important factor in the evaluation of DOE's license 
application. The regulations at 10 CFR 63.114 and 63.304 require the 
performance assessment to provide for the full range of defensible and 
reasonable parameters and models, and account for uncertainty. NRC 
staff review will evaluate the nature and magnitude of the 
uncertainties and the impact of uncertainty on repository performance. 
Consideration of alternative models is one means of evaluating the 
conceptual model uncertainty in performance assessment. The postclosure 
performance assessment requirements in 10 CFR 63.114(c) require DOE to 
consider alternative conceptual models of features and processes that 
are consistent with available data and current scientific understanding 
and to evaluate the effects that alternative conceptual models have on 
the performance of the geologic repository. The Yucca Mountain Review 
Plan provides guidance regarding review of these requirements and that 
DOE has the flexibility to demonstrate compliance, consistent with a 
risk-informed, performance-based licensing approach.
    As discussed in the ``Statement of Considerations'' for 10 CFR part 
63 (66 FR pp. 55747-55748, November 2, 2001), the Commission recognizes 
``* * * the uncertainties inherent in evaluating a first-of-a-kind 
facility like the repository and in estimating system performance over 
very long time periods (i.e., 10,000 years).'' In response to these 
uncertainties, NRC modified 10 CFR part 63 to require that DOE include 
uncertainty in its postclosure performance assessment and provides 
sufficient information to allow NRC to evaluate DOE's uncertainty 
analysis. For example, 10 CFR 63.114(b) requires DOE to account for 
uncertainties and parameter variability, and to provide the technical 
bases for its treatment of uncertainty in the postclosure performance 
assessment. In addition, DOE is required by 10 CFR 63.114(c) to provide 
additional assurances that uncertainty in the information (e.g., 
evaluation of site characterization data) used to develop the 
performance assessment has been evaluated by consideration of 
alternative conceptual models of features and processes that are 
consistent with available data and current scientific understanding. 
The regulation at 10 CFR 63.113(g) provides that DOE conduct 
corroborative testing of its performance assessment to the extent 
feasible, and for DOE to use additional bases beyond performance 
assessment to compensate for uncertainty and to provide confidence that 
the postclosure performance objectives of 10 CFR 63.113 are met. For 
example, 10 CFR part 63, subpart F, requires that a performance 
confirmation program confirm that the behavior of the barriers of the 
repository system is consistent with assumptions in the performance 
assessment. Further, 10 CFR 63.113 and 10 CFR part 63, subpart G, 
require use of multiple barriers and a quality assurance program.
    As described in the ``Statement of Considerations'' for 10 CFR part 
63 (66 FR 55747-55748, November 2, 2001):

    The Commission will consider all these requirements in 
determining whether it has sufficient confidence (i.e., reasonable 
expectation) that DOE has demonstrated or has not demonstrated the 
safety of the repository. Specification of an acceptable level of 
uncertainty is neither practical nor appropriate due to the limited 
knowledge currently available to support any such specification and 
the range of uncertainties that would need to be addressed. The 
Commission believes the approach to performance assessment in the 
proposed rule, which includes the treatment of uncertainty, is 
appropriate and has retained this approach in the final rule.
* * * * *
    If NRC were to specify an acceptable level of uncertainty, the 
specified value would be somewhat arbitrary because: (1) 
Understanding of the site is evolving as site studies continue; (2) 
repository design options are still being evaluated; and (3) 
differences in the types of uncertainties (e.g., variability in 
measured parameters, modeling assumptions, expert judgment, etc.) 
complicate the specification.
* * * * *
    Although the Commission does not require an ``accurate'' 
prediction of the future, uncertainty in performance estimates 
cannot be so large that the Commission cannot find a reasonable 
expectation that the postclosure performance objectives will be met 
(see discussion under ``Reasonable Expectation'') [Section 1.4, 66 
FR 55739-55740]. At this time, the Commission is not aware of any 
information that suggests the uncertainties are so large that NRC 
will be unable to make a regulatory decision regarding the safety of 
a potential repository at Yucca Mountain.

    Each of the performance assessment model abstractions, provided in 
Section 4.2.1.3, ``Model Abstraction,'' of the draft Yucca Mountain 
Review Plan, provides specific review methods and acceptance criteria 
that address both data uncertainty (parameter variability) and model 
uncertainty (whether the model is adequate and appropriate). Therefore, 
the review methods and

[[Page 45098]]

acceptance criteria in the Yucca Mountain Review Plan provide 
sufficient guidance to evaluate DOE's treatment of uncertainty against 
the requirements of 10 CFR part 63.
    Suggested editorial changes were made to the Yucca Mountain Review 
Plan in response to these comments.

5.5 Compliance With Postclosure Public Health and Environmental 
Standards

    Issue: What is the expected groundwater contamination from the 
repository?
    Comment. One commenter expressed concern that the proposed 
repository at Yucca Mountain could have long-term impacts on 
groundwater quality.
    Response. The groundwater pathway is a potential exposure pathway 
as identified in previous DOE and NRC performance assessments for a 
proposed high-level waste repository at Yucca Mountain. Groundwater 
will be protected provided DOE can demonstrate that the groundwater 
protection standard in 10 CFR part 63.331 and 63.332 are met.
    Several Sections 4.2.1.3.6, ``Flow Paths in the Unsaturated Zone,'' 
4.2.1.3.7, ``Radionuclide Transport in the Unsaturated Zone,'' 
4.2.1.3.8, ``Flow Paths in the Saturated Zone,'' and 4.2.1.3.9, 
``Radionuclide Transport in the Saturated Zone,'' of the draft Yucca 
Mountain Review Plan provide specific review methods and acceptance 
criteria to evaluate whether DOE's abstraction of groundwater flow and 
radionuclide transport satisfies the postclosure performance objectives 
at 10 CFR 63.113. In addition, as discussed in the ``Statement of 
Considerations'' for 10 CFR part 63 (66 FR 55758, November 2, 2001):

    The Commission has commented previously that an individual, all-
pathway dose limit of either 0.15-mSv (15-mrem) or 0.25-mSv (25-
mrem) TEDE ensures that the risks from all radionuclides and all 
exposure pathways, including the ground-water pathway, are 
acceptable and protective. The EPA itself acknowledged, in 
publishing final standards for Yucca Mountain, that an ``* * * 
Individual Protection Standard is adequate in itself to protect 
public health and safety.'' However, ultimately, the EPA had to make 
the decision whether to include separate requirements for 
groundwater protection and the final EPA standards for Yucca 
Mountain include such requirements for the purpose of protecting 
groundwater. Therefore, as required by law, final Part 63 
requirements incorporate final U.S. Environmental Protection Agency 
standards for Yucca Mountain at 40 CFR part 197, including separate 
ground-water protection requirements. These requirements, sections 
197.30 and 197.31, appear in the final 10 CFR part 63 regulations as 
sections 63.331 and 63.332, respectively.

    The Yucca Mountain Review Plan has been revised to ensure 
consistency with the groundwater protection standards in 10 CFR 63.331 
and 10 CFR 63.332. These changes, combined with the review methods and 
acceptance criteria in Section 4.2.1.3, ``Model Abstraction,'' of the 
draft Yucca Mountain Review Plan, will ensure that the NRC review of 
DOE's license application takes into account DOE's demonstration of 
compliance with the applicable postclosure performance objective and 
groundwater protection standards.

5.6 Postclosure Monitoring

    Issue: Would there be control over the Yucca Mountain site after 
permanent closure and license termination?
    Comment. Several commenters expressed concern about the extent of 
NRC oversight activities after permanent closure of a high-level waste 
repository at Yucca Mountain. One commenter asked about plans for 
monitoring ambient radiation in the drifts and tunnels after permanent 
closure. Another commenter requested information on security and 
physical protection plans for the repository after permanent closure. 
Other commenters asked NRC to provide a postclosure plan for waste 
retrieval and whether the Yucca Mountain Review Plan addressed possible 
postclosure terrorist problems and the postclosure performance 
assessment.
    Response. If DOE is granted a license, it may seek an amendment 
under 10 CFR 63.51 for permanent closure of a high-level waste 
repository at Yucca Mountain. As part of its amendment request, DOE 
must submit its program for continued oversight, including a 
description of a program for postclosure monitoring of the repository, 
and a detailed description of measures to regulate or prevent 
activities that could impair the long-term performance of the 
repository. NRC will review the adequacy of DOE's programs for 
continued oversight following permanent closure and decontamination of 
surface facilities.
    DOE may also apply for license amendment to terminate the license 
pursuant to 10 CFR 63.52. NRC will terminate the license if it finds 
that final waste disposition conforms to DOE's plan, as amended and 
approved as part of the license, and the geologic repository operations 
area conforms to plans for permanent closure and decontamination or 
decontamination and dismantlement of surface facilities.
    Section 122 of the Nuclear Waste Policy Act provides for retrieval 
of any spent fuel for any reason pertaining to public health and 
safety, or the environment, or for the purpose of permitting the 
recovery of the economically valuable contents of spent fuel. The 
implementing regulations at 10 CFR part 63 provide for retrieval of 
waste before permanent closure of the repository. During a period of 
waste disposal that may extend over several decades, DOE is required by 
license to maintain performance confirmation, monitoring, and security 
programs to ensure that the natural and engineered components assumed 
to operate as barriers during permanent closure of the repository are 
functioning as intended and anticipated at the time of license 
application. Thus, it is DOE that must legally provide security for the 
Yucca Mountain site. NRC staff will evaluate whether the security 
measures would be adequate to protect the site.
    NRC will conduct an inspection program to ensure that DOE complies 
with its license. DOE is not required to have plans in place for 
retrieval or security after permanent closure of the repository.
    The draft Yucca Mountain Review Plan Section 4.5.8, ``Controls to 
Restrict Access and Regulate Land Uses,'' examines compliance with the 
requirements for ownership and control of interests in land. The scope 
of these regulatory requirements includes, among others, land 
acquisition and withdrawal, acceptability of controls through and for 
permanent closure, control over surface and subsurface estates, and 
design of monuments to identify the site. Draft Yucca Mountain Review 
Plan Section 4.5.9, ``Uses of the Geologic Repository Operations Area 
for Purposes Other Than Disposal of Radioactive Wastes,'' examines 
procedures for conduct and continuing oversight of proposed activities. 
These two sections of the Yucca Mountain Review Plan enable NRC staff 
to determine whether adequate security would be provided for the site 
after permanent closure.
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.

6 Research and Development Program To Resolve Safety Issues

6.1 Scope of the Research and Development Program To Resolve Safety 
Questions

    Issue: What is the appropriate scope of the research and 
development program to resolve safety issues?
    Comment. One commenter expressed concern about the text in the 
``Areas of Review'' for Section 4.3, ``Research and

[[Page 45099]]

Development Program to Resolve Safety Questions,'' of the draft Yucca 
Mountain Review Plan. The commenter stated that the research and 
development program was not intended to address the adequacy of site 
characterization or natural barriers, as the review plan currently 
states. The commenter argued that the adequacy of information on these 
two topics should be demonstrated in the license application as 
submitted and that it is not acceptable to use the research and 
development program to resolve safety questions to complete work that 
should have been done before the submittal of the license application.
    Response. The applicable regulation, 10 CFR 63.21(c)(16), states 
that the license application shall contain ``an identification of those 
structures, systems, and components of the geologic repository, both 
surface and subsurface, that require research and development to 
confirm the adequacy of design. For structures, systems, and components 
important to safety and for the engineered and natural barriers 
important to waste isolation, DOE shall provide a detailed description 
of the programs designed to resolve safety questions, including a 
schedule indicating when these questions would be resolved.''
    The research and development program to resolve safety questions 
should be used appropriately to address questions as appropriate. The 
regulation recognizes that some research and development programs are 
confirmatory in nature while others resolve safety questions. The 
license application should contain sufficient information on site 
characterization and natural barriers to enable NRC staff to conduct a 
detailed review of the application.
    The text of Section 4.3 of the draft Yucca Mountain Review Plan has 
been revised to narrow the scope of the research and development 
program to resolve safety questions.

7 Performance Confirmation

7.1 Performance Confirmation Program

    Issue 1: Are the acceptance criteria for performance confirmation 
monitoring and testing too prescriptive?
    Comment. Commenters stated that Section 4.4, ``Performance 
Confirmation Program,'' of the draft Yucca Mountain Review Plan is more 
prescriptive than 10 CFR part 63 regarding specific performance 
confirmation testing and monitoring citing specific examples including 
cases where the language used in Section 4.4 was not identical to 
language used in subpart F of 10 CFR part 63. One commenter stated that 
Section 4.4, like 10 CFR part 60, is prescriptive with regard to 
requirements for particular barriers, and inconsistent with the risk-
informed, performance-based approach in 10 CFR part 63. Commenters 
stated that DOE would determine the parameters, measurements, and 
observations that are appropriate for inclusion in the performance 
confirmation program based on their importance to confirming repository 
performance and to the uncertainties in that performance.
    Response. DOE has the responsibility to determine the parameters, 
measurements, and observations to be included in a performance 
confirmation program. As stated in ``Statement of Considerations'' for 
final 10 CFR part 63 (66 FR 55745, November 2, 2001) ``The Commission 
believes that it is DOE's responsibility to specify the important 
geotechnical and design parameters to be evaluated through observation 
and measurement during construction and operation, subject to NRC 
approval through review and evaluation of the license application. DOE 
will provide this information in their performance confirmation plan 
included in the license application. If necessary, NRC staff will 
provide guidance to DOE in this area through pre-licensing interactions 
and/or the Yucca Mountain Review Plan.''
    With respect to the examples of inconsistency with language in 
subpart F of 10 CFR part 63, the recommended changes were accepted, and 
Section 4.4 has been modified accordingly. However, the fact that a 
specific parameter or process is not mentioned in the regulation, does 
not necessarily mean that parameter or process should not be considered 
for inclusion in the performance confirmation program. Such decisions 
should be made using risk-informed, performance-based approach. In 
developing 10 CFR part 63, the Commission chose not to adopt an 
approach that would prescribe in detail the specifics and limits of a 
performance confirmation program to allow DOE the flexibility to 
develop a focused and effective performance confirmation program (66 FR 
55745, November 2, 2001).
    Section 4.4 of the draft Yucca Mountain Review Plan has been 
modified for consistency with 10 CFR part 63.
    Issue 2: Are the acceptance criteria for procedures supporting the 
performance confirmation program too prescriptive?
    Comment. Commenters stated that the draft Yucca Mountain Review 
Plan is more prescriptive than 10 CFR part 63 regarding procedures 
supporting the performance confirmation program. A commenter stated 
that DOE should have the flexibility to determine the context in which 
procedures need to be developed and that such procedures may be 
developed after a license application for construction authorization is 
submitted. There were also a number of detailed comments specifically 
related to procedures supporting a performance confirmation plan.
    Response. The Yucca Mountain Review Plan recognizes that DOE has 
the flexibility to devise the performance confirmation program 
consistent with regulations, including how to document its methods or 
procedures (whether directly in a performance confirmation plan or 
indirectly by reference to another document). Any procedures referenced 
would be subject to either NRC staff review or inspections.
    Accordingly, Section 4.4 of the draft Yucca Mountain Review Plan 
has been revised to delete the word procedures and to be less 
prescriptive regarding this subject.

8 Administrative and Programmatic Areas

8.1 Record-Keeping Requirements

    Issue: What are the requirements for keeping records of the 
repository and its operations?
    Comment. A commenter asked about the plan for keeping records over 
the 10,000-year life span of a repository at Yucca Mountain and 
requested that records on private shippers of waste to a repository 
should include ``* * * liability information, accident records, 
breached or leaking cask records, judgments, accusations, and penalty 
records.''
    Response. There are a number of record keeping requirements which 
relate to the repository which address many of the items identified by 
the commenter. NRC regulations at 10 CFR part 63, subpart D, specify 
the requirements for maintaining records at a Yucca Mountain high-level 
waste repository, including those required by the conditions of the 
license or by rules, regulations, and orders of the Commission, 
pursuant to 10 CFR 63.71(b). Records of the receipt, handling, and 
disposition of radioactive waste at a geologic repository operations 
area must contain sufficient information to provide a history of the 
movement of the waste from the shipper through all phases of storage 
and disposal. The records must be placed in the archives and land-
record systems of local, State, and Federal government agencies, and 
archives elsewhere in the world. The

[[Page 45100]]

records are to identify the location of the geologic repository 
operations area, including the underground facility, boreholes, shafts 
ramps, and the boundaries of the site, and the nature and hazards of 
the waste.
    DOE must also meet the 10 CFR 63.72 requirement to maintain records 
of construction in a manner that ensures their usability for future 
generations. These construction records must include surveys; a 
description of materials encountered; geologic maps and cross sections; 
locations and amount of seepage; details of equipment, methods, 
progress, and sequence of work; construction problems; anomalous 
conditions encountered; instrument locations, readings, and analyses; 
location and description of structural support systems; location and 
description of dewatering systems; details, methods of emplacement, and 
locations of seals used; and facility design records.
    DOE must also maintain the records required by 10 CFR part 72, 
``Licensing Requirements for the Independent Storage of Spent Nuclear 
Fuel, High-Level Radioactive Waste, and Reactor-Related Greater than 
Class C Waste,'' Subpart D, Sections 72.72, 72.74, 72.76, and 72.78. 
These additional records include material balance, inventory, and 
records requirements for stored material; reports of accidental 
criticality or loss of special nuclear material; material status 
reports; and nuclear material transfer reports.
    DOE would also have to comply with U.S. Department of 
Transportation requirements for shipment of high-level radioactive 
waste and with NRC regulations at 10 CFR part 71, ``Packaging and 
Transportation of Radioactive Material.''
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.

8.2 Land Ownership and Use

    Issue 1: Does the land that might be used for a high-level waste 
repository at Yucca Mountain belong to Native American Tribes?
    Comment. A commenter asked whether, for the purpose of controlling 
access to a repository at Yucca Mountain, the government was sure that 
the land does not belong to Native American Tribes. Another commenter 
asked where the Yucca Mountain Review Plan addressed the requirements 
for DOE to prove ownership and title to the land. A third commenter 
contended that the Ruby Valley Treaty of 1863 is being violated because 
land around the Yucca Mountain site belongs to the Western Shoshone 
Nation.
    Response. NRC regulations at 10 CFR 63.121 require that the 
geologic repository operations area must be located in and on lands 
that are either acquired lands under the jurisdiction and control of 
DOE, or lands permanently withdrawn and reserved for its use. The land 
must also be free from significant encumbrances such as mining rights, 
right-of-ways, or rights of entry. DOE must satisfy these regulations 
in order to be granted a license for a high-level waste repository at 
Yucca Mountain. In its review of the license application, NRC staff 
would determine whether DOE has provided information that demonstrates 
compliance with these requirements. This review is addressed in Section 
4.5.8, ``Controls to Restrict Access and Regulate Land Uses,'' of the 
draft Yucca Mountain Review Plan (Review Method 1 and Acceptance 
Criterion 1). In addition, the Commission addressed tribal claims 
regarding Yucca Mountain in the Statement of Considerations for 10 CFR 
part 63 (66 FR 55766, November 2, 2001):

    The NRC is aware that the Western Shoshone National Council 
disputes the claim of the United States to have legal title to land 
that includes the Yucca Mountain site. However, there are Federal 
court decisions which have addressed these land claim issues and 
which are binding on both DOE and NRC. Section 63.121 requires that, 
before NRC licensing of a waste repository at the Yucca Mountain 
site, DOE must establish that the geologic repository operations 
area and the site are located in and on land that is either acquired 
land under the jurisdiction and control of DOE, or lands permanently 
withdrawn and reserved for DOE's use.

    No changes have been made to the Yucca Mountain Review Plan as a 
result of this comment.
    Issue 2: What uses may be made of a geologic repository operations 
area other than disposal of radioactive waste?
    Comment. One commenter was concerned that there might be plans to 
use a geologic repository operations area for purposes other than 
disposal of radioactive wastes and stated that building a monitored 
retrievable storage facility at Yucca Mountain is specifically 
prohibited by the Nuclear Waste Policy Act.
    Response. Section 4.5.9, ``Uses of Geologic Repository Operations 
Area for Purposes Other than Disposal of Radioactive Wastes,'' of the 
draft Yucca Mountain Review Plan would be used to evaluate compliance 
with the 10 CFR 63.21(c)(22)(vii) requirement that a license 
application must contain ``Plans for uses of the geologic repository 
operations area at the Yucca Mountain site for purposes other than 
disposal of radioactive wastes, with an analysis of the effects, if 
any, that such uses may have on the operation of the structures, 
systems, and components important to safety and the engineered and 
natural barriers important to waste isolation.''
    The regulations require DOE to identify uses that are unrelated to 
waste disposal. Section 141 of the Nuclear Waste Policy Act prohibits 
the construction of a monitored retrievable storage facility at Yucca 
Mountain.
    NRC staff will evaluate any such proposed uses if included in a 
license application for a high-level waste repository at Yucca 
Mountain, and determine whether such uses are contrary to the Nuclear 
Waste Policy Act.
    No changes were made to the Yucca Mountain Review Plan as a result 
of this comment.

8.3 Expert Elicitation

    Issue: What is the appropriate scope for the use of expert 
elicitation?
    Comment. A commenter expressed concerns about the use of expert 
elicitation in a license application for a high-level radioactive waste 
repository at Yucca Mountain. The commenter stated that because DOE has 
had 20 years to obtain data to evaluate the suitability of the Yucca 
Mountain site, DOE use of expert elicitation should be limited and 
should not be a substitute for information obtainable during site 
characterization. The commenter also stated that NRC staff should not 
allow DOE to substitute expert opinion for data that it was afraid to 
collect.
    Response. It is not acceptable to use expert elicitation as a 
substitute for information that could have been reasonably obtained 
during site characterization or to avoid collection of relevant data. 
The regulations at 10 CFR 63.21(c)(19) requires ``an explanation of how 
expert elicitation was used.''
    Section 4.5.4, ``Expert Elicitation,'' of the draft Yucca Mountain 
Review Plan uses NUREG-1563, ``Branch Technical Position on the Use of 
Expert Elicitation in the High-Level Radioactive Waste Program'' (NRC, 
1996). The NUREG-1563 states, in part:

    In matters important to the demonstration of compliance, the use 
of formal expert elicitation should be considered whenever one or 
more of the following conditions exist:
    (a) Empirical data are not reasonably obtainable, or the 
analyses are not practical to perform;
    (b) Uncertainties are large and significant to a demonstration 
of compliance;
    (c) More than one conceptual model can explain, and be 
consistent with, the available data; or

[[Page 45101]]

    (d) Technical judgments are required to assess whether bounding 
assumptions or calculations are appropriately conservative.

    NRC staff will apply this guidance in evaluating an application for 
the construction of a high-level waste repository at Yucca Mountain.
    The Yucca Mountain Review Plan text has been modified to 
specifically state the cited items from NUREG-1563.

8.4 U.S. Department of Energy Organizational Structure

    Issue: Should the Yucca Mountain Review Plan discussion of DOE 
responsibilities for project management be expanded?
    Comment. One commenter noted that the license application should 
contain an evaluation of DOE's procedures for assuring that delegated 
activities are carried out in accordance with the license and with the 
Commission's regulations. The commenter noted that DOE would be 
responsible for safe repository operations, even if certain activities 
are delegated to a contractor. The commenter stated it is unclear 
regarding the procedures that DOE must use to manage the overall 
project, including the delegated activities.
    Response. Draft Yucca Mountain Review Plan Section 4.5.3.1, ``DOE 
Organizational Structure as it Pertains to Construction and Operation 
of Geologic Repository Operations Area,'' provides guidance to NRC 
staff to determine whether DOE's procedures governing its project 
management responsibilities are adequate.
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.

8.5 Water Rights

    Issue: Does the Yucca Mountain Review Plan adequately evaluate 
whether DOE has obtained the necessary water rights for operation of a 
high-level waste repository at Yucca Mountain?
    Comment. One commenter questioned whether DOE would need to have 
obtained water rights to accomplish the purposes of the geologic 
repository operations area. The commenter noted that the phrase ``water 
rights'' has specific meaning in Nevada and suggests that the Yucca 
Mountain Review Plan clarify whether DOE is required to have water 
rights as granted by the State of Nevada or to simply demonstrate that 
an adequate supply of water is available for the site.
    Response. The provisions in Section 4.5.8 of the draft Yucca 
Mountain Review Plan are based on the requirements regarding water 
rights specified in 10 CFR 63.121. DOE must obtain ``such water rights 
as may be needed to accomplish the purpose of the geologic repository 
operations area.'' In addition, for permanent closure, DOE ``* * * 
shall exercise any jurisdiction and control over surface and subsurface 
estates necessary to prevent adverse human actions that could 
significantly reduce the geologic repository's ability to achieve 
isolation. The rights of DOE may take the form of appropriate 
possessory interests, servitudes, or withdrawals from location or 
patent under the general mining laws.''
    No changes were made to the Yucca Mountain Review Plan as a result 
of this comment.

8.6 License Conditions

    Issue: Should the list of proposed license conditions for a high-
level waste repository at Yucca Mountain include mitigating actions 
from the environmental impact statement?
    Comment. One commenter expressed concern that the list of areas for 
which NRC believes DOE should propose license conditions is 
unnecessarily limited and is not consistent with conditions contained 
in licenses for other nuclear facilities. The commenter cites, for 
example, the absence of a provision for adequate off-site emergency 
response and medical capabilities. The commenter suggested that the 
revised plan provide a much more comprehensive listing, for 
consideration of possible license conditions, which would include all 
measures to mitigate repository system impacts identified within the 
Yucca Mountain Final Environmental Impact Statement and impact reports 
prepared by others.
    Response. Mitigating actions that might be required as a result of 
potential environmental impacts of a repository at Yucca Mountain must 
be addressed by DOE in the Yucca Mountain Final Environmental Impact 
Statement. The content of the Yucca Mountain Final Environmental Impact 
Statement is outside the scope of the safety review encompassed by the 
Yucca Mountain Review Plan. NRC staff will evaluate the Yucca Mountain 
Final Environmental Impact Statement in accordance with Commission 
regulations at 10 CFR part 51 and applicable regulations. If 
appropriate, mitigating actions may be identified as license 
conditions.
    The list of areas for potential license conditions presented in the 
Yucca Mountain Review Plan guidance is not all-inclusive. Under 10 CFR 
63.42, the Commission will impose any conditions, including license 
specifications, it considers necessary to protect public health and 
safety, the common defense and security and the environment. NRC staff 
has modified the section in the Yucca Mountain Review Plan to make 
reviewers aware that the listing is not intended to be complete. 
License conditions will be imposed on a high-level waste repository at 
Yucca Mountain determined based on a review of information presented in 
the license application, as well as the environmental impact statement, 
as needed to reach the reasonable assurance or reasonable expectation 
standard for the repository.

8.7 Quality Assurance

    Issue 1: Are Yucca Mountain Review Plan quality assurance 
acceptance criteria consistent with 10 CFR part 63 requirements and 
relevant regulatory guidance?
    Comment 1. A commenter stated that the draft Yucca Mountain Review 
Plan applies quality assurance acceptance criteria that seem to exceed 
or expand on 10 CFR part 63 requirements and relevant regulatory 
guidance, such as NRC-endorsed consensus standards, American Society of 
Mechanical Engineers Standard NQA-1, other nuclear facility review 
plans, and standard industry practice as implemented under 10 CFR parts 
21, 50, 70, and 72. The commenter stated that the draft Yucca Mountain 
Review Plan, therefore, unnecessarily constrains the license 
applicant's ability to establish quality assurance program 
implementation methods by setting expectations for specific compliance 
or implementation methods that are rigid and differ significantly from 
those applicable to other nuclear facilities regulated by NRC.
    Another commenter stated that the draft Yucca Mountain Review Plan 
quality assurance acceptance criteria are too restrictive, are 
inconsistent with other NRC criteria for quality assurance program 
descriptions, and would require continual application of the quality 
assurance program description change process.
    The commenters specified a number of places in the Yucca Mountain 
Review Plan related to their concerns.
    Response 1. The Yucca Mountain Review Plan quality assurance 
acceptance criteria are consistent with 10 CFR part 63, subpart G, 
requirements and relevant regulatory guidance. In preparing the Yucca 
Mountain Review Plan, NRC staff considered many sources of information 
including consensus standards, American Society of Mechanical Engineers 
Standard NQA-1, other nuclear facility standard review plans, and 
standard industry

[[Page 45102]]

practice. NRC staff tailored information from those sources to the 
unique requirements specifically applicable to a Yucca Mountain 
repository.
    As stated in Section 4.5.1, ``Quality Assurance Program,'' of the 
draft Yucca Mountain Review Plan, DOE has flexibility in defining 
methods and controls while still satisfying pertinent regulations, and 
DOE may adopt exceptions and alternatives to the 18 acceptance criteria 
in the Yucca Mountain Review Plan, provided DOE can otherwise show it 
satisfies the requirements in 10 CFR part 63.
    No changes have been made to the Yucca Mountain Review Plan as a 
result of this comment.
    Comment 2. Two commenters questioned whether quality assurance 
acceptance Criteria 19-22, that address software, sample control, 
scientific investigation, and field surveys, respectively, are 
necessary and whether these areas are already adequately covered by 
quality assurance acceptance criteria 1-18.
    Response 2. The Yucca Mountain Review Plan quality assurance 
acceptance criteria are consistent with the quality assurance criteria 
of 10 CFR part 50, appendix B, which apply to nuclear power plants and 
fuel reprocessing plants. Criteria 19-22 clarify certain quality 
assurance requirements in 10 CFR part 50, appendix B, for application 
to the Yucca Mountain repository. However, these four acceptance 
criteria did not expand the scope of applicability for quality 
assurance.
    To maintain consistency between the structure in the Yucca Mountain 
Review Plan and quality assurance requirements in 10 CFR part 63, 
subpart G, NRC staff has consolidated specific acceptance criteria 19-
22 into specific acceptance criteria 3, 8, and 10 as follows: 
Acceptance Criterion 19, ``Software,'' and Acceptance Criterion 21, 
``Scientific Investigation,'' have been consolidated into Acceptance 
Criterion 3, ``Design Control''; Acceptance Criterion 20, ``Sample 
Control,'' has been consolidated into Acceptance Criterion 8, 
``Identification and Control of Materials, Parts, and Components''; and 
Acceptance Criterion 22, ``Field Surveys,'' has been consolidated into 
Acceptance Criterion 10, ``Inspection.''
    Issue 2: Are Yucca Mountain Review Plan quality assurance 
acceptance criteria and review methods more prescriptive than 
appropriate for a risk-informed, performance-based regulatory approach?
    Comment. A commenter argued that many of the quality assurance 
acceptance criteria and review methods prescribe quality assurance 
program features more narrowly than is consistent with risk-informed, 
performance-based principles. The commenter stated that this approach 
limits the license applicant to a program that is not based on common 
nuclear industry practice and would place an unnecessary burden on the 
applicant to justify deviation from the specified approach. The 
commenter further stated that this approach would result in a 
description of implementation details in the quality assurance program 
description that may be more appropriate for inclusion in detailed 
implementing procedures.
    The commenter identified a number of specific locations in the 
Yucca Mountain Review Plan that are related to these comments.
    Response. The Yucca Mountain Review Plan quality assurance 
acceptance criteria are appropriate for a risk-informed, performed-
based quality assurance program. The Yucca Mountain Review Plan quality 
assurance acceptance criteria provide guidance on issues associated 
with the uniqueness of the geologic repository. Exceptions from Yucca 
Mountain Review Plan approaches are acceptable, so long as the quality 
assurance requirements in 10 CFR part 63 are satisfied. Exceptions and 
alternatives to the acceptance criteria contained in the Yucca Mountain 
Review Plan may be adopted by DOE, provided DOE demonstrates that it 
can otherwise satisfy the requirements of part 63.
    A quality assurance program description written in compliance with 
10 CFR part 63, subpart G, is specifically tailored to the proposed 
high-level waste repository at Yucca Mountain and the Yucca Mountain 
Review Plan incorporates appropriate NRC quality assurance guidance. 
The Yucca Mountain Review Plan states that, where appropriate, the 
quality assurance program description may reference a commitment to 
comply with certain provisions of documents identified in Section 
4.5.1.5 of the draft Yucca Mountain Review Plan and need not repeat the 
text of the document in the quality assurance program description.
    No changes have been made to the Yucca Mountain Review Plan as a 
result of this comment.
    Issue 3: Should certain text from quality assurance standards that 
is included in the Yucca Mountain Review Plan be replaced by references 
to the corresponding text in those standards?
    Comment. A commenter stated that many of the more prescriptive 
acceptance criteria appear to be direct or modified excerpts from 
references that could be more simply identified as NRC-endorsed 
sources, allowing the license applicant to maintain flexibility in 
developing implementation methods, consistent with risk-informed, 
performance-based principles. The commenter argued that the Yucca 
Mountain Review Plan should only reference these sources as acceptable 
means to implement NRC's quality assurance regulations.
    A number of specific locations in the Yucca Mountain Review Plan 
where these comments apply were identified.
    Response. Several quality assurance standards referenced in the 
Yucca Mountain Review Plan were written for a 10 CFR part 50, appendix 
B-type quality assurance program. Although 10 CFR part 50, appendix B 
requirements are similar to 10 CFR part 63 quality assurance 
requirements, unique considerations associated with a geologic high-
level waste repository that relies on both natural and engineered 
barriers pose major differences. Therefore, the Yucca Mountain Review 
Plan includes text from these quality assurance standards, modified as 
necessary, in order to provide clear guidance during a license 
application review. This approach provides guidance on, and background 
for, the quality assurance elements unique to the geologic repository 
in one document. Section 4.5.1, ``Quality Assurance Program'' of the 
draft Yucca Mountain Review Plan states, ``Where appropriate, the 
quality assurance program description may reference a commitment to 
comply with certain provisions of a document identified in Section 
4.5.1.5 of the draft Yucca Mountain Review Plan and not repeat the text 
of the document in the quality assurance program.''
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.
    Issue 4: Should the Yucca Mountain Review Plan reference more 
recent quality assurance standards?
    Comment. Three commenters recommended using a more recent edition 
of standard NQA-1 rather than NQA-1-1983 and revising the text of the 
Yucca Mountain Review Plan accordingly. Another commenter suggested 
incorporating Nuclear Safety Standards from July 2002.
    Response. NRC endorses standards through the use of regulatory 
guides. These regulatory guides provide sufficient detail to ensure 
that programs and activities governed by such standards comply with the 
applicable regulations.

[[Page 45103]]

    Licensees with 10 CFR part 50, appendix B, quality assurance 
programs have committed to using quality assurance standard NQA-1-1983, 
the latest edition endorsed by NRC in Regulatory Guide 1.28 or 
committed to the ANSI 45.2 series standards. More recent editions of 
NQA-1 do not contain sufficient detail to describe how the applicable 
NRC quality assurance requirements would be satisfied. For example, in 
NQA-1-1997, many detailed provisions have either been removed from the 
standard or relocated to a non-mandatory appendix.
    However, Section 4.5.1, ``Quality Assurance Program,'' of the draft 
Yucca Mountain Review Plan provides that ``Exceptions and alternatives 
to these acceptance criteria and the documents and positions contained 
in Section 4.5.1.5 of the draft Yucca Mountain Review Plan may be 
adopted by DOE, provided the applicant can otherwise demonstrate 
compliance with quality assurance program requirements in 10 CFR part 
63.'' Therefore, DOE may propose alternatives to the Yucca Mountain 
Review Plan quality assurance acceptance criteria, provided adequate 
justification is submitted to demonstrate that the proposed 
alternatives adequately describe how the quality assurance requirements 
of 10 CFR Part 63 will be satisfied.
    No changes have been made to the Yucca Mountain Review Plan in 
response to this comment.
    Issue 5: Which nonmandatory requirements of NQA-1-1983 must be 
followed?
    Comment. A commenter stated that the Yucca Mountain Review Plan is 
not clear on the use of the ``non-mandatory guidance'' in NQA-1-1983.
    Response. Guidance on the use of nonmandatory requirements in NQA-
1-1983 is sufficiently clear in the Yucca Mountain Review Plan. 
Commitment to NQA-1-1983 requirements is subject to exceptions, 
clarifications, or modifications provided in the Yucca Mountain Review 
Plan quality assurance acceptance criteria or Paragraph C of 
``Regulatory Position,'' of Regulatory Guide 1.28. Any nonmandatory 
requirements identified in NQA-1-1983 that are not addressed in either 
the Yucca Mountain Review Plan quality assurance acceptance criteria or 
Paragraph C of Regulatory Guide 1.28 need not be followed.
    No changes have been made to the Yucca Mountain Review Plan in 
response to this comment.
    Issue 6: Which elements of the quality assurance program should be 
in place at the time of license application submittal?
    Comment. A commenter recommended that the Yucca Mountain Review 
Plan clearly state which elements of DOE's quality assurance program 
should be in place at the time of license application submittal. The 
commenter stated an expectation that, as for nuclear power reactor 
licensing activities, the quality assurance program description would 
be submitted to NRC separately from the Safety Analysis Report, well 
before the quality assurance program is fully implemented. Field 
procedures would be in place, with follow-on commitments to ensure that 
planned programmatic activities are implemented.
    Response. The time frame for implementation of the quality 
assurance program is sufficiently clear in the Yucca Mountain Review 
Plan. Section 4.5.1.3, ``Acceptance Criteria,'' states that ``The DOE 
quality assurance program and associated quality assurance program 
controls and implementing procedures regarding activities performed 
must be in place before activities begin.'' These activities include 
site characterization; acquisition, control, and analysis of samples 
and data; tests and experiments; scientific studies; facility and 
equipment design and construction; and performance confirmation.
    Section 4.5.1.3 of the draft Yucca Mountain Review Plan has been 
modified to identify these activities.
    Issue 7: Should the step-wise licensing approach be applied to the 
review of the quality assurance program description?
    Comment. A commenter recommended that the step-wise licensing 
approach be applied to the content and level of detail of the quality 
assurance program description required for the different phases of 
repository licensing. Another commenter stated that, typically, a 
quality assurance program description that encompasses all phases of 
repository construction, operation, and closure, as required by the 
Yucca Mountain Review Plan quality assurance acceptance criteria, is 
prepared in stages (i.e., there are specific elements of the quality 
assurance program description required to be submitted and reviewed for 
the design and construction phase/activities, whereas others are 
required to be submitted and reviewed for the operations phase). This 
commenter also stated that, although some of the elements of the 
quality assurance program descriptions are similar among licensing 
steps, there are different policies, organizations, programs, and 
procedures that will be implemented for each step.
    Response. A step-wise licensing approach should be applied to the 
review of the quality assurance program description. Section 4.5.1.3 of 
the Yucca Mountain Review Plan has been modified to state the 
following:

    The U.S. Department of Energy shall establish a quality 
assurance program to include all activities up to the time of 
receipt of high-level radioactive waste for disposal in the geologic 
repository. These activities include site characterization; 
acquisition, control, and analysis of samples and data; tests and 
experiments; scientific studies; facility and equipment design and 
construction; and performance confirmation. The Yucca Mountain 
Review Plan will be modified, at the appropriate time, to include 
facility operation, permanent closure, and decontamination and 
dismantling of surface facilities. The U.S. Nuclear Regulatory 
Commission staff should assure that the scope of the Yucca Mountain 
Review Plan includes those activities described in the U.S. 
Department of Energy quality assurance program under review. 
Appropriate conditions should be imposed on quality assurance 
program and Yucca Mountain Project approvals that reflect the scope 
of activities described in the quality assurance programs and 
applications submitted for U.S. Nuclear Regulatory Commission review 
and approval by the U.S. Department of Energy.

    Issue 8: Why are quality assurance program references (Section 
4.5.1.5) divided into two groups?
    Comment. A commenter stated that the rationale is not clear for 
division of quality assurance references'' between ``commitments'' and 
``noncommitments.''
    Response. Identifying the scope of potentially applicable 
information will facilitate a licensing review and preparation of a 
more complete license application. The ``commitments'' listing of 
references is mandatory. Commitments are required to be addressed by 
DOE. The ``noncommitments'' are not mandatory, but guidance documents 
that may be used by both DOE and NRC staff reviewers as a source of 
additional guidance. If noncommitment documents are identified in the 
license application, NRC staff can refer to these same documents during 
the review process.
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.
    Issue 9: Is it necessary to have both general and specific 
acceptance criteria for the review of the quality assurance program 
description?
    Comment. A commenter argued that because there are no ``general'' 
quality assurance requirements identified in the applicable NRC 
regulations, it is inappropriate to have ``general'' quality

[[Page 45104]]

assurance acceptance criteria, in addition to ``specific'' quality 
assurance acceptance criteria, in the Yucca Mountain Review Plan. The 
commenter requested clarification as to the difference between the 
general and specific acceptance criteria and provided specific 
recommendations for revisions.
    Response. The general acceptance criteria in Section 4.5.1.3 of the 
draft Yucca Mountain Review Plan provide NRC staff with a broad view of 
the overall quality assurance requirements and the specific criteria 
provide the details of the individualized quality assurance 
requirements. Reiteration of the requirements is useful to promote 
consistency in NRC staff review.
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.
    Issue 10: Is the Yucca Mountain Review Plan guidance for review of 
the quality assurance program description appropriate for performance 
assessment?
    Comment. A commenter recommended revisions to reflect a quality 
assurance program geared to performance assessment, rather than only 
experimental activities and calculations.
    Response. A preclosure safety analysis and a postclosure 
performance assessment regulatory requirements are important components 
in evaluating the Yucca Mountain project. The quality assurance 
terminology is appropriate and adequate for performance assessment 
because it has been proven effective in a wide range of applications.
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.
    Issue 11: How much overlap is appropriate between acceptance 
criteria in Section 4.5.1, ``Quality Assurance Program,'' and Section 
4.2.1.3, ``Model Abstraction'?
    Comment. A commenter stated that the data and model criteria in 
Acceptance Criterion 21 of Section 4.5.1.3, ``Acceptance Criteria'' 
appear to be redundant or inconsistent with the technical requirements 
in Section 4.2.1.3, ``Model Abstraction.''
    Response. In response to other comments, Acceptance Criterion 21, 
``Scientific Investigation,'' has been consolidated into Acceptance 
Criterion 3, ``Design Control.'' This change has not changed the scope 
of the quality assurance requirements.
    Issue 12: How should quality assurance software requirements be 
applied?
    Comment. Two commenters requested clarification as to which types 
of software were subject to quality assurance software requirements. 
One commenter argued that quality assurance software requirements 
should apply only to software developed to support a safety or waste 
isolation function.
    Response. Section 4.5.1, ``Quality Assurance Program,'' of the 
Yucca Mountain Review Plan has been modified to specify that it applies 
to software developed to support functions important to safety or to 
waste isolation.
    Issue 13: Should the discussion of the corrective action program be 
clarified?
    Comment. Two commenters recommended that the discussion of the 
corrective action program be clarified with respect to terminology, 
procedures, and the role of quality assurance staff in the program.
    Response. The discussion of the corrective action program in 
Section 2.5.13 of the draft Yucca Mountain Review Plan is appropriate 
as written because it is consistent with widely accepted and proven 
approaches to corrective action in quality assurance programs.
    No changes have been made to the Yucca Mountain Review Plan in 
response to this comment.
    Issue 14: Is the review of quality control and certification for 
nuclear waste transportation canisters and casks and their fabrication 
included in the review of the quality assurance program description?
    Comment. A commenter asked whether NRC will review the quality 
control for the manufacturing processes used to produce nuclear waste 
transportation canisters and casks. The commenter also asked whether 
NRC will specify conditions or criteria for certification of canisters 
and whether manufacturing processes, construction, and quality control 
issues are periodically reviewed by NRC to ensure adherence to approved 
certification criteria and that canisters are constructed to required 
specifications.
    Response. Under 10 CFR part 71, NRC is responsible for certifying 
the designs of shipping casks that may be used to move commercial 
nuclear waste by truck or rail to Yucca Mountain. NRC will also review 
the manufacturing processes used to produce transportation canisters 
and will periodically inspect the manufacturing processes and 
construction to ensure that design criteria are adhered to and that 
transportation canisters are constructed to applicable specifications.
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.
    Issue 15: What is the scope of license applicant qualification 
information that should be covered in the review of the quality 
assurance program description?
    Comment. A commenter recommended that NRC provide for a thorough 
review of the background, experience, management capability, and track 
record of the license applicant in the Yucca Mountain Review Plan.
    Response. DOE, in accordance with 10 CFR 63.21(c)(22), is required 
to include information about its organizational structure as it 
pertains to construction and operation of the repository, and the 
personnel qualifications and training requirements. NRC has a program 
in place to observe detailed technical and programmatic audits of DOE's 
Yucca Mountain project and its contractors. Various aspects of DOE's 
quality assurance program, specifically with regard to the Yucca 
Mountain project, are routinely evaluated by NRC. However, only the 
license applicant activities specifically related to a Yucca Mountain 
repository fall under the scope of the regulatory requirements in 10 
CFR part 63.
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.
    Issue 16: Should the text be revised to address various 
consistency, clarification, editorial, and format issues?
    Comment. A commenter provided several comments on various 
consistency, clarification, editorial, format, and other miscellaneous 
issues.
    Response. Section 4.5.1, ``Quality Assurance Program'' of the draft 
Yucca Mountain Review Plan has been modified, as appropriate, to 
incorporate various editorial changes for consistency, clarification, 
and format issues related to this comment.

9 Structure of the Yucca Mountain Review Plan

9.1 Level of Detail

    Issue: Is the level of detail in the Yucca Mountain Review Plan 
appropriate to guide the review of a license application?
    Comment. Commenters noted that the degree of specification in 
review methods varies substantially throughout the Yucca Mountain 
Review Plan. In some sections, presumptions are made as to what is 
important to safety or waste isolation by including discussion of 
specific design solutions (e.g., backfill). The commenters consider 
these assumptions to be inconsistent with the risk-informed, 
performance-based regulations at 10 CFR part 63. The

[[Page 45105]]

commenters suggested that the Yucca Mountain Review Plan be revised to 
clarify that the applicant will specify structures, systems, and 
components important to safety and natural and engineered barriers 
important to waste isolation, compatible with the risk-informed, 
performance-based regulations. The commenters noted that since these 
presumptions occur throughout the document, a general discussion in the 
Yucca Mountain Review Plan ``Introduction'' could address the issue.
    One commenter stated that the general description of the geologic 
repository must include detailed descriptions of surface and interim 
storage facilities. The commenter also stated that the general 
information review should focus on natural threats to repository 
integrity and identified a number of such specific potential threats. 
Another commenter requested more detailed information on the status of 
activities to meet requirements for ownership and control of interests 
in land and on the schedule for meeting these requirements.
    Another commenter stated that the general information section of 
the Yucca Mountain Review Plan indicates that information be presented 
at the level of an ``executive summary,'' but the actual level of 
detail requested is more appropriate for discussion in the safety 
analysis report rather than in an executive summary.
    Response. DOE has the responsibility to specify structures, 
systems, and components that are important to safety and multiple 
barriers both natural and engineered important to waste isolation. This 
responsibility is noted in several places in the Yucca Mountain Review 
Plan. The Yucca Mountain Review Plan makes no presumptions regarding 
these structures, systems, components, or barriers, and mentions 
specific design features only as examples or to restate language in 
NRC's regulations.
    The general information submitted with a license application, as 
required by 10 CFR 63.21(b)(1) and (2), need not contain detailed 
descriptions of surface and interim storage facilities and other 
features, events, and processes that might exist or occur at a 
repository for high-level radioactive waste at Yucca Mountain, or of 
the status of compliance with specific regulatory requirements. The 
general information portion of a license application includes a 
description of the proposed repository at Yucca Mountain, including an 
identification of the location of the repository operations area, the 
general character of proposed activities, proposed schedules for 
construction, receipt and emplacement of waste. This information should 
be at a level of detail to provide the reviewer enough background 
information to provide a context for detailed reviews of information 
using, for example, Chapter 4, ``Review Plan for Safety Analysis 
Report,'' of the draft Yucca Mountain Review Plan. Reviews conducted 
using Chapter 4 of the plan will require detailed descriptions of 
surface and interim storage facilities proposed in the facility design 
as well as evaluations of the features, events, and processes that 
might occur at a repository. It is not necessary that such information 
be duplicated in the ``General Information'' section of the Yucca 
Mountain Review Plan.
    In the general information section of the Yucca Mountain Review 
Plan, material should be addressed at the level of a summary and should 
not duplicate the detailed information required to be stated in the 
safety analysis report.
    The Yucca Mountain Review Plan has been modified to clarify the 
purpose of the general information section is to request descriptive 
information (except with respect to the detailed security plan measures 
that are required by 10 CFR part 63), and to reflect in the 
Introduction section (now Appendix A) that NRC staff has made no 
presumptions regarding which items contribute to performance.

9.2 Information and Level of Detail Required for Each Licensing Step

    Issue: Should the Yucca Mountain Review Plan more clearly 
acknowledge the step-wise licensing process and define the level of 
detail that would be applicable for each licensing step for a 
repository at Yucca Mountain.
    Comment. Commenters stated that regulations in 10 CFR part 63 
confirm that repository licensing will occur in steps and that the 
level of detail required to proceed with each licensing step will 
increase as more information is obtained. According to one commenter, 
in developing this step-wise approach to repository licensing, NRC drew 
on decades of experience in licensing nuclear reactors in discrete 
steps under regulations at 10 CFR part 50.
    The commenters argued that the Yucca Mountain Review Plan should 
clearly acknowledge that a step-wise licensing approach is applicable 
to a repository and that the license application should include not 
only a description of the robustness of the system and an assessment of 
performance, but also an acknowledgment that additional information 
will continue to be developed.
    The commenters stated that the draft Yucca Mountain Review Plan 
does not clearly and consistently differentiate the information needed 
for the different steps of licensing. Accordingly, the plan does not 
differentiate how the areas of review, review methods, and acceptance 
criteria should vary for each of the licensing steps.
    One commenter stated that, although DOE is expected to develop a 
sufficiently robust and well-documented license application that would 
permit NRC to independently determine the safety of a repository, DOE 
is not expected to have resolved all design and long-term repository 
performance issues at the construction authorization step. However, one 
commenter expressed a concern that the draft Yucca Mountain Review Plan 
inappropriately allows the DOE to simply commit to complying with 
certain regulatory requirements rather than to demonstrate actual 
compliance.
    The commenter identified locations in the draft Yucca Mountain 
Review Plan that are related to these comments.
    Response. The regulations at 10 CFR 63.21(a) require that ``[T]he 
application must be as complete as possible in the light of information 
that is reasonably available at the time of docketing.'' The Commission 
addressed the step-wise licensing approach in its ``Statement of 
Considerations'' for 10 CFR part 63 (66 FR 55738-55739, November 2, 
2001) in which it stated:

    Part 63 provides for a multi-staged licensing process that 
affords the Commission the flexibility to make decisions in a 
logical time sequence that accounts for DOE collecting and analyzing 
additional information over the construction and operational phases 
of the repository. The multi-staged approach comprises four major 
decisions by the Commission: (1) Construction authorization; (2) 
license to receive and emplace waste; (3) license amendment for 
permanent closure; and (4) termination of license. The time required 
to complete the stages of this process (e.g., 50 years for 
operations and 50 years for monitoring) is extensive and will allow 
for generation of additional information. Clearly, the knowledge 
available at the time of construction authorization will be less 
than at the subsequent stages. However, at each stage, [the] DOE 
must provide sufficient information to support that stage. DOE has 
stated its intent to submit, and NRC expects to receive, a 
reasonably complete application at the time of construction 
authorization to allow the Commission to make a construction 
authorization decision. This is reflected in the requirement at 
Section 63.24(a) that the application be as complete as possible in 
light of information that is reasonably available at the time of 
docketing. The

[[Page 45106]]

Commission believes the regulations, as proposed, provide the 
necessary flexibility for making licensing decisions consistent with 
the amount and level of detail of information appropriate to each 
licensing stage. However, we agree with DOE that the proposed 
requirement at Section 63.24(a) speaks to the content of the initial 
application, as well as to all subsequent updates, and, therefore, 
it has been included at the end of Section 63.21(a).

    The information provided at each stage should be sufficient for NRC 
staff to make the requisite findings for the licensing action being 
contemplated, whether, for example, it be issuance of a construction 
authorization or a license to receive and possess waste.
    The Yucca Mountain Review Plan has been revised, as appropriate, to 
clarify the step-wise approach to licensing a geologic repository for 
high-level waste at Yucca Mountain and the information required for 
each licensing step.

9.3 Organization of the Yucca Mountain Review Plan

    Issue 1: Should the Yucca Mountain Review Plan be reorganized to 
better support both preparation of an application and a licensing 
review?
    Comment. Commenters noted that having a license application 
correspond to the structure of the Yucca Mountain Review Plan is 
important for NRC staff's review. Similarly, since the DOE will have to 
prepare and maintain a safety analysis report throughout the lifetime 
of a repository, a structure that most efficiently presents the 
required information is also important. The commenters suggested that a 
Yucca Mountain Review Plan more similar in structure to a reactor 
license application would facilitate license preparation by DOE, review 
of the application by NRC, and maintenance of the safety evaluation 
report over the lifetime of the facility. The commenters also suggested 
that restructuring of some areas of the Yucca Mountain Review Plan, 
such as the performance confirmation section, would enhance the 
transparency and traceability to DOE's supporting technical 
information. Specific recommendations to achieve this restructuring 
were provided for the preclosure safety; postclosure safety; and 
general information sections of the plan. The commenters also suggested 
that NRC state in the Yucca Mountain Review Plan that DOE may use a 
format different from that presented in the Yucca Mountain Review Plan.
    With respect to the preclosure safety section of the Yucca Mountain 
Review Plan, one commenter suggested that a logical format would be to 
present design information followed by the preclosure safety analysis. 
This format would allow design information relevant to each structure, 
system, and component to be presented in its own subsection, rather 
than being split into separate areas as in the Yucca Mountain Review 
Plan. The commenter noted that as low as is reasonably achievable 
requirements are typically addressed as a design requirement for normal 
operations rather than as a consequence of hazards. Therefore, the 
commenter recommended that the as low as is reasonably achievable 
requirements be addressed in a new subsection of the Yucca Mountain 
Review Plan that provides a comprehensive review of the radiation 
protection program proposed for the facility. This new section would 
cover the as low as is reasonably achievable design aspects as well as 
the commitment to these principles during operations.
    With respect to the postclosure safety section of the draft Yucca 
Mountain Review Plan, commenters noted that the draft Yucca Mountain 
Review Plan structure differs from that used previously by DOE and 
could make it difficult to present a cohesive story regarding total 
system performance while demonstrating compliance with the five 
acceptance criteria for each model abstraction. The commenter 
recommended that the Yucca Mountain Review Plan be rewritten to 
generally state that the five review methods (and corresponding 
acceptance criteria) are to be applied to the model abstractions as DOE 
determines. The commenter notes that, in previous documents, DOE 
communicated its postclosure safety approach in terms of the movement 
of water from the surface through the mountain to the accessible 
environment, which is different from the structure currently presented 
in the Yucca Mountain Review Plan.
    Commenters identified locations in the draft Yucca Mountain Review 
Plan relevant to their concerns.
    Response. The Yucca Mountain Review Plan should provide a structure 
for the license application as a means to promote efficiency in both 
preparation of an application by DOE and the license application review 
by NRC staff. Long-term maintenance of the safety analysis report might 
also be enhanced. The structure of the Yucca Mountain Review Plan was 
intended to provide this structure and to inform the prospective 
applicant as to the preferred organizational structure of the license 
application.
    Organization of the application along the lines of a power reactor 
application may not be appropriate for a potential repository for high-
level waste. Among the considerations that defined the structure of the 
Yucca Mountain Review Plan are: (i) The requirements for the content of 
a license application at 10 CFR 63.21; (ii) the need to focus a 
licensing review on compliance with risk-informed, performance-based 
performance objectives being implemented in 10 CFR part 63; and (iii) 
the specification, in 10 CFR part 63, of techniques to be used to 
demonstrate compliance both during operations and after permanent 
closure.
    Because regulatory guidance cannot impose regulatory requirements, 
DOE is not required to use the format presented in the Yucca Mountain 
Review Plan, however, a different format could prolong the duration of 
the NRC licensing review.
    As for the suggestion that the preclosure safety section (Section 
4.1 of the draft Yucca Mountain Review Plan) first present design 
information followed by the preclosure safety analysis, the approach 
currently in the plan is consistent with the steps required for a 
preclosure safety analysis. These techniques are based on hazard and 
consequence analysis methodologies that are widely accepted for complex 
facilities. The purpose of the preclosure safety analysis is to 
determine whether the preclosure performance objectives will be met. 
Consequently, the review steps in the Yucca Mountain Review Plan 
logically lead from hazard identification through consequence analyses 
to assessment of compliance with performance objectives. Related to 
this approach is the need to use risk information to focus the NRC 
staff review. The preclosure safety analysis will be used by DOE to 
identify those structures, systems, and components important to safety. 
Since these structures, systems, and components have not yet been 
identified, the Yucca Mountain Review Plan is not structured around the 
design of the repository.
    As low as is reasonably achievable requirements are typically 
addressed as a design requirement for normal operations rather than as 
a consequence of hazards. However, for a preclosure safety analysis for 
a repository meeting these requirements can appropriately be linked to 
the radiological risks of a repository. Since these risks will be 
evaluated as part of the preclosure safety analysis process, NRC staff 
prefers to evaluate them as part of its review of DOE's preclosure 
safety analysis.
    Comments on the postclosure safety section of the Yucca Mountain 
Review Plan may have misinterpreted the review approach. NRC staff is 
aware that

[[Page 45107]]

the current DOE Total System Performance Assessment uses nine process 
level models (similar to NRC's model abstractions) that are based on 
the flow of water through a repository to the location of the 
reasonably maximally exposed individual. In light of the key role 
performance assessment will play in demonstrating and determining 
compliance, NRC staff has been developing an independent performance 
assessment capability for a Yucca Mountain repository and discussed the 
published results with DOE at numerous public meetings. The NRC total 
system performance assessment incorporates 14 model abstractions that 
represent its independent conceptual model of a Yucca Mountain site. 
The Yucca Mountain Review Plan describes how NRC staff will determine 
compliance, and its independently developed total system performance 
assessment code will be an important tool in assessing whether DOE has 
satisfied regulatory requirements. Therefore, the Yucca Mountain Review 
Plan facilitates the use of this tool in the license application 
review. DOE's compliance demonstration method may use similar, or 
different, conceptual models. NRC staff review, based on its 14 model 
abstractions, is described in detail in the Yucca Mountain Review Plan. 
This detail is useful because NRC staff has learned a great deal about 
the features, events, and processes of the Yucca Mountain site, and 
this knowledge is reflected in the technical information specific to 
each of the 14 model abstractions.
    Although specific details of the postclosure portion of the Yucca 
Mountain Review Plan have been revised to address this comment, the 
general structure has not been changed. The Yucca Mountain Review Plan 
was revised, as appropriate, to clarify the matters raised in these 
comments.
    Issue 2: Should quality assurance requirements be specifically 
addressed in each section of the Yucca Mountain Review Plan?
    Comment. One commenter stated that quality assurance requirements 
should be identified and specified in the review methods and acceptance 
criteria for each section of the Yucca Mountain Review Plan. The 
commenter argued that Section 3.2, ``Proposed Schedules for 
Construction, Receipt, and Emplacement of Waste,'' Review Method 1, and 
Acceptance Criterion 1, of the draft Yucca Mountain Review Plan, should 
explicitly mention quality assurance compliance, since state-of-the-art 
quality assurance begins with preliminary scheduling and includes 
impacts on schedules, work interdependence, and work flow, particularly 
during construction. The commenter also suggested four specific changes 
to this section of the Yucca Mountain Review Plan that would 
incorporate quality assurance requirements.
    Response. The quality assurance requirements in 10 CFR part 63 
apply to aspects of repository construction, operation, or closure that 
are important to safety or to waste isolation. While quality assurance 
is an integral part of almost all aspects of a licensing review for a 
high-level waste repository, the Yucca Mountain Review Plan includes a 
single section on quality assurance, which will be applied to each of 
the other review activities.
    To clarify the importance of quality assurance, the Yucca Mountain 
Review Plan integrates quality assurance into the entire licensing 
review by using the review methods and acceptance criteria in the 
``Quality Assurance Program'' section of the Yucca Mountain Review Plan 
and applying them to reviews conducted for other Yucca Mountain Review 
Plan sections.
    No changes to the Yucca Mountain Review Plan were made as a result 
of this comment.
    Issue 3: Should the distinction between a licensing review and 
inspection activities be specifically addressed in each section of the 
Yucca Mountain Review Plan?
    Comment. One commenter stated that the distinction between 
licensing review and inspection activities should be highlighted in 
each section of the Yucca Mountain Review Plan.
    Another commenter suggested that NRC staff conduct a comprehensive 
review of the plan to ensure that the level of detail being specified 
is appropriate for a licensing review, rather than an inspection 
review. The commenter also suggested that Figure 1.1 in the plan be 
clarified for this purpose and that the ``Introduction'' to the Yucca 
Mountain Review Plan be revised to more explicitly outline this 
principle.
    Response. It is not necessary to draw a distinction between 
licensing review and inspection in each section of the Yucca Mountain 
Review Plan in that it would substantially lengthen the review plan 
without adding significant benefit or clarity to the licensing review. 
This approach would also be inconsistent with other agency review 
plans.
    As part of NRC's inspection program for a high-level waste 
repository at Yucca Mountain, NRC staff would prepare an Inspection 
Manual inspection procedures and would train additional inspectors. 
Inspection would thus be addressed separately.
    No changes have been made to the Yucca Mountain Review Plan as a 
result of this comment.
    Issue 4: Is the Yucca Mountain Review Plan excessively redundant 
and difficult to understand?
    Comment. One commenter stated that although the Yucca Mountain 
Review Plan meets the purpose for which it was written and explains the 
bases for activities and roles of various entities, it is repetitive 
particularly with respect to ``Areas of Review,'' ``Review Methods,'' 
``Acceptance Criteria,'' ``Evaluation Findings,'' and ``References.'' 
The commenter noted that such headings, along with common verbiage, is 
repeated for topics, which are separately discussed for both preclosure 
and postclosure safety reviews. Although the commenter indicated that 
this approach may support the uniformity of the NRC review, it makes 
the document quite long. The commenter suggested that a table could be 
used as an abbreviated form of what currently appears as narrative 
under the headings (e.g., ``Acceptance Criteria,'' ``Evaluation 
Findings,'' etc.) for each of the topics involved and for each major 
section of the review plan.
    Response. The Yucca Mountain Review Plan is lengthy and somewhat 
redundant. The structure and format of the review plan, however, is 
intended to guide NRC staff reviewers from various disciplines to 
perform an efficient and complete review in discrete areas and provide 
the relevant information in each section. The structure of the Yucca 
Mountain Review Plan is also consistent with other NRC review plans.
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.
    Issue 5: Should the Yucca Mountain Review Plan include an example 
of how a review would be completed and the results documented?
    Comment. One commenter noted that the Yucca Mountain Review Plan 
sections dealing with postclosure issues reflect the risk perspectives 
of 10 CFR part 63 appropriately, but cautioned that implementation of 
the Yucca Mountain Review Plan will determine whether a risk 
perspective is followed. The commenter noted that the review plan 
identifies the need to maintain flexibility in review guidelines at the 
expense of specificity and acceptance criteria contain guidance to NRC 
staff for evaluating such aspects as: (1) Whether sufficient data are 
available to adequately define relevant parameters and conceptual 
models; (2) whether models use parameter values, assumed

[[Page 45108]]

ranges, probability distributions, and bounding assumptions that are 
technically defensible; and (3) whether the technical bases for the 
parameter values are consistent with data from the Yucca Mountain 
region. The commenter argued that the critical issue will be how items 
such as data sufficiency and model adequacy are determined and 
suggested adding an appendix to the Yucca Mountain Review Plan, which 
provides an abbreviated illustration of a review of a specific issue. 
This might be achieved using one of the integrated subissues, with 
specific reference to the prelicensing agreements between NRC staff and 
DOE staff as to how questions about sufficiency and adequacy would be 
addressed in the review process. The commenter noted that such an 
example might be very useful. In providing such an example, NRC staff 
could clarify what might lead to a conclusion that the license 
application was inadequate.
    Response. An example of a review and the documentation of the 
results would be helpful to users of the Yucca Mountain Review Plan. 
One has been incorporated in Appendix A.
    Issue 6: Will the Yucca Mountain Review Plan be revised in the 
future?
    Comment. One commenter acknowledged that the Yucca Mountain Review 
Plan is a living document and agreed that physical protection is a 
potential area of change. The commenter questioned whether, considering 
the expected length of time between initial emplacement of waste and 
repository closure, it is reasonable to anticipate and accommodate 
change.
    Response. Because the document is intended to address several steps 
in licensing of a high-level waste repository, the Yucca Mountain 
Review Plan will be revised in the future, if appropriate.
    No changes to the Yucca Mountain Review Plan were made as a result 
of this comment.

9.4 Content of Yucca Mountain Review Plan Glossary

    Issue: Should the Yucca Mountain Review Plan glossary include terms 
that are not defined in the text?
    Comment. One commenter identified approximately forty terms that 
are used in the Yucca Mountain Review Plan text, but are not defined. 
The commenter suggested that these terms be added to the glossary.
    Response. The glossary should define the terms used in the Yucca 
Mountain Review Plan. The glossary, however, provides general 
definitions and is not intended to be exhaustive as to all technical 
terms that may be used by a reviewer of a license application.
    In response to this comment, the glossary has been revised to add 
terms that would be useful to a general reader.

9.5 Use of a Risk-Informed, Performance-Based Yucca Mountain Review 
Plan

    Issue 1: Is the Yucca Mountain Review Plan sufficiently risk-
informed, and performance-based?
    Comment. One commenter noted the NRC commitment to conduct a risk-
informed, performance-based licensing review for a potential high-level 
waste repository at Yucca Mountain. However, the commenter stated that 
the application of risk-informed, performance-based principles in the 
Yucca Mountain Review Plan was uneven. The commenter cited examples 
from the ``Introduction'' (now Appendix A) to the Yucca Mountain Review 
Plan that indicated risk-informed, performance-based principles were 
applied only where there was some reason to do so. The commenter argued 
that application of such principles should be a fundamental part of all 
NRC review activities. The commenter cited several specific examples 
from the Introduction to make the point that risk-informed, 
performance-based principles were unevenly applied in the Yucca 
Mountain Review Plan.
    In addition, the commenter defined three items needed to 
consistently apply risk-informed, performance-based principles in the 
Yucca Mountain Review Plan: (i) Recognition that DOE has the latitude 
to make risk-informed, performance-based judgments as to what should be 
included in a license application and that NRC will determine whether 
it agrees with these judgments; (ii) revision of sections of the Yucca 
Mountain Review Plan that contain an excessive level of detail, 
particularly those sections dealing with repository design and 
Commission assumptions about the relative importance of specific 
features, events, and processes; and (iii) recognition that risk-
informed, performance-based principles are especially important in a 
step-wise licensing process.
    In support of these arguments, that commenter stated that 
consistent application of risk-informed, performance-based licensing 
principles would allow flexibility and would encourage the learning and 
development that would occur over a repository lifetime, thereby 
improving the protection of health and safety.
    Finally, the commenter identified specific locations in the draft 
Yucca Mountain Review Plan that are inconsistent with risk-informed, 
performance-based principles; contain an excessive level of detail or 
prescription; or preclude necessary licensee flexibility. These 
locations are summarized here.
    (1) Section 3, ``Review Plan for General Information,'' is, in 
general, overly detailed and prescriptive.
    (2) Section 3 does not adequately recognize that, at the 
construction authorization stage, information in some areas may not be 
as highly developed as in others.
    (3) Section 4.2.1.3, ``Model Abstraction,'' could be significantly 
streamlined. Rather than redundantly repeating the five generic 
Acceptance Criteria and related guidance, this material could be stated 
once and then applied to each of the 14 model abstractions. (This 
comment was made by another commenter on the review plan as well). The 
commenter stated that making this change would require a rewrite of the 
entire section, resulting in approximately 10 pages, rather than 109 
pages, which could be applied with improved consistency and 
flexibility.
    (4) Section 4.4, ``Performance Confirmation Program,'' is 
inconsistent with the risk-informed, performance-based nature of 10 CFR 
Part 63, would be impractical to implement, and contradicts what has 
been learned about total system performance assessment and subsystem 
performance requirements by placing detailed stipulations on the 
specific scientific and technical measures that must be taken to meet 
the already stated expectations of the ``Performance Confirmation 
Program.'' (Responses to comments received on Section 4.4 of the draft 
Yucca Mountain Review Plan are consolidated in Section 7 of this 
comment response document).
    (5) Section 4.5.1, ``Quality Assurance,'' is too restrictive, 
inconsistent with other NRC criteria for Quality Assurance Program 
Descriptions, and will necessitate continual implementation of the 
Quality Assurance Program Description change process. (Responses to 
comments received on Section 4.5.1 of the draft Yucca Mountain Review 
Plan are consolidated in Section 8 of this comment response document.)
    One commenter suggested that ``risk-informed,'' and ``performance-
based'' be specifically defined in the Yucca Mountain Review Plan.
    Response. Changes have been made throughout the Yucca Mountain 
Review Plan to address these and other comments. For example, the 
review plan explains that DOE may make risk-informed, performance-based 
judgments as to what should be included in a license application, and 
NRC has to

[[Page 45109]]

assess these judgments. NRC staff has revised sections of the Yucca 
Mountain Review Plan that contain an excessive level of detail, 
particularly those sections dealing with repository design and NRC 
assumptions about the relative importance of specific features, events, 
and processes. The Yucca Mountain Review Plan recognizes that risk-
informed, performance-based principles are especially important in a 
step-wise licensing process.
    Some specific comments, however, were not incorporated.
    Regulations at 10 CFR part 63 were specifically written to 
implement a risk-informed, performance-based approach to licensing. 
Quantitative performance measures for the repository are found in the 
radiation health and protection standards that are implemented in 10 
CFR part 63. In addition, 10 CFR part 63 specifies use of multiple 
barriers, performance confirmation, and other requirements in 
demonstrating performance. There are some techniques, programs, and 
guidance for regulating the use of radioactive material, however, that 
have proven to be efficient and effective for a wide range of licensees 
and that were adopted in 10 CFR part 63. Among these areas are 
operational health physics, material control and accountability, and 
emergency preparedness. For these reasons, the Yucca Mountain Review 
Plan does not reflect major changes in the way these programs would be 
implemented at other facilities regulated by NRC.
    An applicant may propose approaches to areas such as operational 
health physics, physical protection, material control and 
accountability, and emergency preparedness that depart from those 
outlined in the guidance of the Yucca Mountain Review Plan. If DOE 
otherwise demonstrates it satisfies regulatory requirements, that is, 
that the public health and safety, as well as the environment, would be 
protected, NRC staff would find those approaches acceptable.
    Section 4.2.1.3, ``Model Abstraction,'' of the draft Yucca Mountain 
Review Plan is lengthy and somewhat redundant, but was structured to 
best reflect how NRC staff would conduct its licensing review. Each of 
the 14 model abstractions has its unique technical and regulatory 
issues. Although the five generic acceptance criteria are applicable to 
each of the model abstraction reviews, for the convenience of the 
reviewer, the review procedures and acceptance criteria are listed 
separately for each model abstraction. Accordingly, the 
multidisciplinary team that conducts each model abstraction review will 
be able to use a separate section of the review plan.
    In summary, changes have been made throughout the Yucca Mountain 
Review Plan to more effectively implement a risk-informed, performance-
based licensing review, but brevity has not been the primary goal.
    Issue 2: To what extent should NRC staff rely on the applicant in 
developing risk insights?
    Comment. One commenter noted that findings of compliance or 
noncompliance will need to be substantiated, suggesting that NRC staff 
performs a detailed review or a simplified review of a particular 
feature will be decided by how important DOE's safety analysis 
considers the feature to be to the overall repository performance. On 
the other hand, the Yucca Mountain Review Plan contains language that 
suggests that the scope of the review will be determined in part by 
what DOE deems important, but also in part by risk insights developed 
by NRC staff from using its own knowledge of the site and its own 
analyses of performance assessment models. The commenter strongly 
favored the latter approach.
    The commenter urged NRC staff not to be guided solely by the 
applicant on the depth of the review of an application and to continue 
to build agency insights about important contributors to risk at the 
proposed repository.
    Response. One purpose of the Yucca Mountain Review Plan is to 
provide guidance to NRC staff on how to conduct a risk-informed, 
performance-based licensing review for a potential high-level waste 
repository at Yucca Mountain. The review plan, as revised, clarifies 
that the risk-informed, performance-based review, is not dictated 
solely by DOE.
    Issue 3: How will risk-informed, performance-based principles be 
applied in a Yucca Mountain licensing review?
    Comment. Several comments addressed the use of risk insights, to 
focus the review on those areas most important to repository 
performance. One commenter asked how NRC would decide which areas are 
most important to repository performance, and how the extent of the 
review of a given portion of the license application would be 
determined.
    One commenter noted that Section 4.2.1.2.2, ``Identification of 
Events with Probabilities Greater Than 10 -\8\ Per Year,'' of the draft 
Yucca Mountain Review Plan does not mention the risk-informed, 
performance-based review approach, and suggested that this section 
should be combined with Section 4.2.1.2.1, ``Scenario Analysis,'' of 
the draft Yucca Mountain Review Plan.
    Another commenter asked whether NRC staff was aware that DOE's 
results were being probability weighted.
    Response. Practical experience in conducting iterative performance 
assessments for the Yucca Mountain site has provided NRC staff with 
valuable insight regarding areas that are most likely to be important 
to health and safety. Until DOE submits a license application, however, 
it is premature to identify those areas of the postclosure performance 
assessment that would require the most detailed review. The review of 
DOE's scenario analysis and event probability described in Section 
4.2.1.2 of the draft Yucca Mountain Review Plan would provide an 
initial foundation for focusing on credible events affecting repository 
performance. The review methods and acceptance criteria in Section 
4.2.1.3, ``Model Abstraction,'' of the draft Yucca Mountain Review Plan 
provide a mechanism for evaluating the different sections of DOE's 
postclosure performance assessment. NRC staff would focus its review 
accordingly based on information in the DOE application and the areas 
that are most important to health and safety.
    The concept of a risk-informed, performance-based review has been 
reiterated in this section and the text has been modified to clarify 
that establishing a probability range is an aspect of a risk-informed 
approach.
    Section 4.2.1.2.2 has not been combined with Section 4.2.1.2.1. 
Section 4.2.1.2.2 addresses the specific requirements of 10 CFR 
63.114(a)(4), and Section 4.2.1.2.1 addresses the specific requirements 
of 10 CFR 63.114(a)(5) and (6).
    NRC staff review will determine whether probability weighting of 
results is mathematically and technically used appropriately in the 
license application.
    Section 4.2.1.2.2 of the Yucca Mountain Review Plan has been 
clarified and modified in response to this comment.

9.6 Use of Guidance and Experience From Regulating Other Nuclear 
Facilities

    Issue: To what extent should NRC rely on guidance and experience 
from regulating other nuclear facilities when evaluating a license 
application for a potential high-level waste repository at Yucca 
Mountain?
    Comment. One commenter expressed concern that, because 10 CFR part 
63 does not have performance objectives for administrative and 
programmatic

[[Page 45110]]

aspects, NRC staff relied on experience from regulating other nuclear 
facilities, including nuclear power plants, in developing these parts 
of the Yucca Mountain Review Plan. The commenter also noted that some 
of the preclosure sections of the draft Yucca Mountain Review Plan 
apparently rely on experience with fuel cycle facilities and nuclear 
power plants, but urged that the operations at the proposed Yucca 
Mountain repository have little in common with nuclear power plants 
and, hence, many reactor-related guidance documents may not be 
transferable. The commenter argued that repeated references to reactor-
based documents (e.g., NUREGs-2300 and 1278; Regulatory Guides 1.109 
and 8.38; and references to the design of systems that are important to 
safety) support the observation that the Yucca Mountain Review Plan 
relies heavily on NRC documents prepared for and used in conjunction 
with the licensing of nuclear power plants.
    The commenter suggested that NRC staff reevaluate inclusion of 
material from nuclear power plant reviews, and delete material and 
requirements that are not relevant to the safety of the proposed Yucca 
Mountain repository. For material deemed relevant, NRC staff should 
explain in the Yucca Mountain Review Plan, the use and relevance of 
reactor-based guides and policies, and should indicate where use of 
such material has been modified to account for differences between 
high-level waste disposal and nuclear power plant operation.
    Response. The Yucca Mountain Review Plan has been modified to 
clarify that only applicable guidance, or portions of that guidance, 
are proposed for use in a licensing review for a high-level waste 
repository.

9.7 Use of Graphics

    Issue: Could use of graphics clarify the purposes and use of the 
Yucca Mountain Review Plan?
    Comment. Commenters stated that a process diagram that illustrates 
how decisions are made and how inadequacies are addressed would be 
helpful. Commenters noted that Figure 1-3 in ``Components of 
Performance Assessment Review'' provided information on how the 
potential for engineered barrier failure would be addressed and asked 
how other topics would be addressed.
    One commenter recommended the use of tables, charts, and graphics 
to give the reader a high-level overview of activities under the Yucca 
Mountain Review Plan. The commenter suggested that an ``activity 
network,'' which diagrams how the Yucca Mountain Review Plan would be 
used would help identify linkages among plan sections. The commenter 
argued that an activity network diagram would also help communicate the 
completeness of the Yucca Mountain Review Plan and make the report more 
understandable to stakeholders.
    Another commenter suggested that an appendix that referenced 
requirements from 10 CFR part 63 to the Yucca Mountain Review Plan 
would be useful.
    Response. Graphics could be useful in promoting understanding of 
the Yucca Mountain Review Plan, and two have been added. One depicts 
the steps of the licensing process, and one describes how review of a 
license application section would be conducted using the Yucca Mountain 
Review Plan. Accompanying text in the review plan explains the 
graphics.
    An appendix that cross-references requirements from 10 CFR part 63 
to the Yucca Mountain Review Plan was not included because the related 
regulatory requirements are already identified in the evaluation 
findings portion of each review plan section.
    Changes to address aspects of these comments were added to the new 
Appendix A (Licensing Review and the Yucca Mountain Review Plan) of the 
review plan.

9.8 Completeness of the Yucca Mountain Review Plan

    Issue: Is the scope of the Yucca Mountain Review Plan adequate to 
evaluate the health and safety of a potential high-level waste 
repository at Yucca Mountain?
    Comment. Several commenters had concerns regarding the adequacy of 
the scope of the Yucca Mountain Review Plan. The concerns included 
omission of potentially significant features, events, and processes; 
the nature of information that would be reviewed using the Review Plan 
for General Information; requirements for the size of restricted areas; 
the adequacy of the scope of a preclosure safety analysis; specificity 
of required design information; and the possibility that acceptance 
criteria were too lenient and subjective.
    Response. The scope of the Yucca Mountain Review Plan is adequate 
and allows flexibility to evaluate whatever methods DOE might choose to 
demonstrate compliance.
    The purpose of the ``Review Plan for General Information'' section 
of the Yucca Mountain Review Plan is to ensure that the requirements of 
10 CFR 63.21(b) have been met. The General Information section of a 
license application should provide a general understanding of the 
engineering design concept for the repository and of the aspects of the 
Yucca Mountain site and its environs that influence repository design 
and performance. Information provided by DOE in response to the 
requirements of 10 CFR 63.21(b) for the General Information section 
should be at the level of an executive summary and is not expected to 
be detailed. The level of detail requested for the site 
characterization description in the General Information section of the 
Yucca Mountain Review Plan has been substantially reduced. Detailed 
information would be evaluated with respect to its importance to health 
and safety in sections that address review of DOE's Safety Analysis 
Report.
    The probability and consequences of features, events, and processes 
would be subjected to a detailed review using review methods and 
acceptance criteria in the section of the Yucca Mountain Review Plan 
that examines Repository Safety After Permanent Closure.
    There is no regulatory requirement mandating the size of restricted 
areas. However, general practice is that these areas are as small as 
operationally feasible to facilitate monitoring and control. A DOE 
physical protection plan would have maps and diagrams associated with 
physical protection methods and procedures inside restricted areas as 
required by 10 CFR 73.51.
    The Yucca Mountain Review Plan identifies the methods and criteria 
NRC staff would use to determine regulatory compliance. The review 
methods and acceptance criteria in the Yucca Mountain Review Plan are 
flexible rather than prescriptive because: (i) NRC regulations at 10 
CFR part 63 are risk-informed and performance-based, (ii) prescriptive 
review methods and acceptance criteria could foreclose the license 
applicant from using the most effective approaches to regulatory 
compliance, and (iii) DOE has not yet presented a preclosure safety 
analysis.
    The Yucca Mountain Review Plan has been modified throughout, as 
appropriate, to clarify the scope of the risk-informed, performance-
based review methods and acceptance criteria.

10 Selected Topics

10.1 Consistency With Regulations

    Issue 1: Should the terminology in the Yucca Mountain Review Plan 
be made more consistent with regulations and be used in a more 
consistent manner?
    Comment. Several commenters stated that the draft Yucca Mountain 
Review Plan uses terms that are inaccurate or

[[Page 45111]]

are inconsistent with the applicable regulations. The commenters 
recommended that the Yucca Mountain Review Plan be revised to more 
closely reflect the applicable regulations to minimize questions of 
interpretation. The commenters also suggested that the Yucca Mountain 
Review Plan directly reference appropriate regulations rather than 
paraphrasing them.
    For example, the term ``safety case'' is used throughout the draft 
Yucca Mountain Review Plan, but is not defined either within the review 
plan or in 10 CFR part 63. One commenter stated that this term 
generally addresses more than a compliance demonstration, and confusion 
about its use may adversely affect both preparation and review of an 
application.
    Commenters noted that terms used in the draft Yucca Mountain Review 
Plan were confused with common industry terms. For example, the terms 
``technical specifications'' and ``license specifications'' are 
erroneously used interchangeably. ``License specifications'' is used 
and defined in 10 CFR part 63 and its use in the Yucca Mountain Review 
Plan should be consistent with this definition. Also, the term 
``license conditions'' is used interchangeably with the term ``license 
specifications.'' In 10 CFR 63.43, license specification is defined in 
terms of license condition, but the Yucca Mountain Review Plan does not 
provide sufficient distinction between the two terms.
    One commenter recommended replacing the term ``performance-based'' 
with ``experimental'' due to the lack of experience in storage for 
thousands of years. The commenter noted that use of the phrases ``risk-
informed'' and ``performance-based'' was problematic because risk 
should mean probability times consequence, but this was not apparent in 
the Yucca Mountain Review Plan. The commenter further noted that the 
phrase ``risk-informed, performance-based,'' as applied over a period 
of thousands or millions of years require a workable definition.
    Two commenters expressed concern with the discussion of ``open 
items'' or ``confirmatory items'' that might result from the licensing 
review. One argued that these items could be used to inappropriately 
accommodate licensing deficiencies and asked for assurance that such 
action would be prevented.
    Another commenter requested that the term ``important to 
performance'' be defined consistent with 10 CFR part 63 and that the 
terms ``important to safety'' and ``important to waste isolation'' be 
included in the Yucca Mountain Review Plan glossary.
    The commenters included a number of additional suggestions for 
improving Yucca Mountain Review Plan consistency and the effectiveness 
of the glossary.
    Response. Terminology should be used consistently throughout the 
Yucca Mountain Review Plan and should be consistent with regulations. 
Revisions were made to the Yucca Mountain Review Plan, as appropriate, 
to address terminology concerns raised by commenters.
    The term ``safety case'' has been removed from the Yucca Mountain 
Review Plan and, generally, has been replaced with the term ``license 
application.'' This change is more consistent with language in 10 CFR 
part 63; however, the removal of the term ``safety case'' should not be 
viewed as a lessening of an emphasis on health and safety for the 
repository.
    Discussion and use of the terms ``technical specifications,'' 
``license specifications,'' and ``license conditions'' have been 
clarified throughout the Yucca Mountain Review Plan to be consistent 
with 10 CFR 63.42 and 62.43. License conditions include license 
specifications that are derived from analyses and evaluations included 
in the application.
    In developing 10 CFR part 63 and the Yucca Mountain Review Plan, 
NRC staff sought to establish a coherent body of risk-informed, 
performance-based criteria for Yucca Mountain that is compatible with 
the Commission's overall philosophy of risk-informed, performance-based 
regulations. [``Use of Probabilistic Risk Assessment Methods in Nuclear 
Regulatory Activities--Final Policy Statement'' (60 FR 42622, August 
16, 1995).] Stated succinctly, risk-informed, performance-based 
regulation is an approach in which risk insights, engineering analysis 
and judgment (e.g., defense in depth), and performance history are used 
to: (i) Focus attention on the most important activities; (ii) 
establish objective criteria for evaluating performance; (iii) develop 
measurable or calculable parameters for monitoring system and licensee 
performance; (iv) provide flexibility to determine how to meet the 
established performance criteria in a way that will encourage and 
reward improved outcomes; and (v) focus on the results as the primary 
basis for regulatory decision-making.
    NRC defines risk as probability times consequence. Further, 10 CFR 
part 63 establishes the regulatory period of interest for a Yucca 
Mountain repository at 10,000 years, consistent with the Nuclear Waste 
Policy Act.
    With respect to the concerns about possible misuse of ``open'' and 
``confirmatory'' items, NRC will review the application to determine 
whether the requisite regulatory showing has been made and impose 
conditions, as necessary to address confirmatory items. ``Open'' items 
that relate to information required for regulatory findings must be 
addressed by DOE during the review.
    The term ``important to performance'' has been replaced with 
``important to safety'' or ``important to waste isolation,'' as 
appropriate, consistent with 10 CFR part 63.
    These and other changes were made throughout the Yucca Mountain 
Review Plan to clarify the guidance and provide consistency with 
regulatory requirements.
    Issue 2: Is the Yucca Mountain repository program being conducted 
consistent with legal requirements?
    Comment. One commenter stated that the Yucca Mountain Review Plan 
violates a number of legislative mandates, Federal laws, an executive 
order, State and local constitutions, and an international treaty. Such 
documents include: The Nuclear Waste Policy Act; the National 
Environmental Policy Act; the Federal Administrative Procedures Act; 
the Safe Drinking Water Act; the Federal Facilities Management Act; 
Executive Order 12898 (``Federal Actions to Address Environmental 
Justice in Minority Populations and Low-Income Population''); the Ruby 
Valley Treaty of 1863; and regulations related to uncompensated 
takings.
    Response. The Yucca Mountain Review Plan is a guidance document 
that sets forth an approach for NRC staff to determine whether the 
regulatory requirements of 10 CFR part 63 have been met. The 
regulations at 10 CFR part 63 were adopted in accordance with the laws 
of the United States. Any challenges to those regulations should be 
raised in the appropriate forum and are not appropriate for comment 
here.
    No changes have been made to the Yucca Mountain Review Plan as a 
result of this comment.

10.2 Nature of Wastes To Be Disposed of in a High-Level Waste 
Repository

    Issue: What types of radioactive wastes may be emplaced in a 
repository for high-level radioactive waste at Yucca Mountain?
    Comment. One commenter asked several questions regarding the types 
and forms of waste that would be eligible for disposal in a repository 
for high-level radioactive waste at Yucca Mountain, Nevada. The 
questions included: (i) Whether liquid wastes could be interred; (ii) 
whether low-level or intermediate-level wastes could be interred; (iii) 
whether contaminated

[[Page 45112]]

operations equipment could be disposed of; (iv) whether radioactive 
chemical wastes could be interred; and (v) whether contaminated soils 
or contaminated mine tailings could be disposed of.
    Response. The types and forms of waste that could be disposed of in 
a repository for high-level radioactive waste at Yucca Mountain are 
based on Section 2 of the Nuclear Waste Policy Act, as amended, and are 
defined in NRC regulations at 10 CFR 63.2. High-level waste means: (i) 
The highly radioactive material resulting from the reprocessing of 
spent nuclear fuel, including liquid waste produced directly in 
reprocessing and any solid material, derived from such liquid waste, 
that contains fission products in sufficient concentrations; (ii) 
irradiated reactor fuel; and (iii) other highly radioactive material 
that the Commission, consistent with existing law, determines, by rule, 
requires permanent isolation. Also, 10 CFR 63.2 defines radioactive 
waste as high-level waste and radioactive materials other than high-
level waste that are received for emplacement in a geologic repository.
    The Commission addressed the question of liquid wastes in its 
``Statement of Considerations'' for 10 CFR part 63 (66 FR 55773, 
November 2, 2001), which states:

    Because of processing in the nuclear fuel cycle, some high-level 
waste can occur in the liquid (aqueous) state. However, this waste 
type is not expected to be disposed of at Yucca Mountain. Rather, 
liquid high-level waste will be vitrified--mixed with molten glass 
and solidified--to reduce the actual volume of waste and make it 
easier to handle.

    DOE would have to demonstrate in its license application that 
wastes that are not the highly radioactive material resulting from the 
reprocessing of spent nuclear fuel (including liquid waste produced 
directly in reprocessing and solid material derived from such liquid 
waste that contains fission products in sufficient concentrations) or 
irradiated reactor fuel, are wastes that the Commission, consistent 
with existing law, determines, by rule, requires permanent isolation.
    No changes were made to the Yucca Mountain Review Plan as a result 
of this comment.

10.3 The Meaning of Safety

    Issue: Will results of a review conducted using the Yucca Mountain 
Review Plan adequately protect health and safety?
    Comment: One commenter questioned whether a licensing review for a 
high-level waste repository at Yucca Mountain that is based on the 
regulatory requirements in 10 CFR part 63, and that uses the review 
methods and acceptance criteria in the Yucca Mountain Review Plan, 
would protect health and safety.
    The commenter referred to a dictionary definition of safety as 
meaning free from danger and involving no risk. The commenter contended 
that this is the public interpretation of safety, and that agencies of 
the Federal government use different definitions since the Yucca 
Mountain Review Plan glossary does not define safety. The commenter 
assumed that the dictionary definition applies.
    The commenter further noted that, when Yucca Mountain was selected 
as the sole site for characterization as a geologic repository, 
officials of DOE promised not to build the site if it was unsafe. The 
commenter stated that DOE often referred citizens to site suitability 
guidelines that included qualifying and disqualifying conditions. Also, 
NRC regulations included sub-system requirements that would ensure the 
site could be licensed only if safety could be assured. The commenter 
noted that these regulatory provisions have been eliminated and that a 
safety decision would now be based on the results of performance 
assessment. The commenter also stated that DOE has redefined safe in 
terms of satisfying regulations.
    Response. A decision on whether to authorize construction of a 
high-level waste repository at Yucca Mountain will be based on whether 
DOE demonstrates it has satisfied applicable regulatory requirements. 
The standards for issuance of a construction authorization, for 
example, include a determination that (1) There is reasonable assurance 
that the types and amounts of radioactive materials described in the 
application can be received in the repository without unreasonable risk 
to public health and safety and (2) there is reasonable expectation 
that materials can be disposed of without unreasonable risk to public 
health and safety.
    Among the requirements that must be met are the preclosure and 
postclosure performance objectives that are defined in NRC regulations 
at 10 CFR part 63. Simply stated, these performance objectives are 
quantitative radiation exposure limits. The Commission addressed the 
adequacy of performance assessment for evaluating compliance in its 
``Statement of Considerations'' for 10 CFR part 63 (66 FR 55746-55747, 
November 2, 2001) as follows.

    Although repository postclosure performance is evaluated with 
respect to a single performance measure for individual protection, 
the NRC considers a broad range of information in arriving at a 
licensing decision. In the case of the proposed repository at Yucca 
Mountain, Part 63 contains a number of requirements (e.g., 
qualitative requirements for data and other information, the 
consideration and treatment of uncertainties, the demonstration of 
multiple barriers, performance confirmation program, and QA program) 
designed to increase confidence that the postclosure performance 
objective is satisfied. The Commission will rely on the performance 
assessment as well as DOE's compliance with these other requirements 
in making a decision, if DOE submits a license application for 
disposal of HLW at Yucca Mountain. The Commission believes the 
approach for performance assessment in the proposed rule is 
appropriate and it is retained in the final rule. However, 
requirements for QA, multiple barriers, and performance confirmation 
have been revised to clarify the Commission's intent for these 
requirements * * *
    The Commission believes that there have been significant 
advances in, and experience with, risk assessment in the past 20 
years (see Commission's white paper on Risk-Informed and 
Performance-Based Regulation, March 1999). The Commission continues 
to believe that a performance assessment, developed with sufficient 
credibility, is the best means to provide useful information to the 
Commission for making an informed, reasonable licensing decision. 
The Commission recognizes, however, the uncertainties inherent in 
evaluating a first-of-a-kind facility like the repository and in 
estimating system performance over very long time periods (i.e., 
10,000 years). Thus, proposed Part 63 contained requirements to 
ensure that: (1) Uncertainties inherent in any performance 
assessment are thoroughly articulated and analyzed or addressed; (2) 
DOE's performance assessment is tested (corroborated) to the extent 
practicable; and (3) there are additional bases, beyond the 
performance assessment, that provide confidence that the postclosure 
performance objectives will be met.

    In essence, safety is defined by 10 CFR part 63. A determination as 
to whether a repository for high-level radioactive waste at Yucca 
Mountain can be operated safely will be based on the information 
presented in a license application, and the evidence presented in the 
adjudicatory proceeding before the NRC.
    No changes have been made to the Yucca Mountain Review Plan in 
response to this comment.

10.4 Reasonable Assurance and Reasonable Expectation

    Issue: Does the difference in the meanings of the terms 
``reasonable assurance'' and ``reasonable expectation'' need to be 
clarified?

[[Page 45113]]

    Comment. One commenter asked that the meanings of the terms 
reasonable assurance and reasonable expectation be clarified. The 
commenter stated that, as used in the draft Yucca Mountain Review Plan, 
these terms seem to mean approximately the same thing. The commenter 
argued that this was not the intent of NRC when it promulgated 10 CFR 
part 63.
    The commenter agreed that use of reasonable assurance as a measure 
of compliance for preclosure safety was appropriate and consistent with 
NRC regulation of other nuclear facilities. However, the commenter 
opined that reasonable expectation implies a different standard that 
recognizes the inherent uncertainties in predicting repository 
performance far into the future. The differences include the need for 
realistic, rather than bounding, modeling approaches, and for taking 
into account the stepwise nature of repository licensing. According to 
the commenter, a reasonable expectation standard should allow for 
considerable information to be added after a license is initially 
granted, but before repository closure. The commenter argued that 
reasonable expectation should allow gaps in understanding to exist at 
the time a license is initially granted, provided adequate efforts to 
address these gaps are implemented.
    The commenter added that the U.S. Environmental Protection Agency 
defined reasonable expectation in 40 CFR part 197 with the intent that 
it be explicitly different from reasonable assurance and allowed NRC 
the flexibility to determine how the term would be applied. Since the 
Yucca Mountain Review Plan is the key NRC implementation guidance, the 
distinction between reasonable assurance and reasonable expectation 
should be clear in the Review Plan.
    Response. The Commission addressed its adoption and use of the 
reasonable expectation and reasonable assurance regulatory compliance 
standards in its ``Statement of Considerations'' for 10 CFR part 63 (66 
FR 55739-55740, November 2, 2001) where it stated:

    Confidence that DOE has, or has not, demonstrated compliance 
with EPA's standards is the essence of NRC's licensing process. It 
is the Commission's responsibility to determine whether DOE has or 
has not demonstrated compliance. The Commission does not believe 
that NRC's use of ``reasonable assurance'' as a basis for judging 
compliance compels focus on extreme values (i.e., tails of 
distributions) for representing the performance of a Yucca Mountain 
repository. Further, if DOE is authorized to file a license 
application, and if the Commission is called on to make a decision, 
irrespective of the term used, the Commission will consider the full 
record before it. That record will include many factors in addition 
to whether the site and design comply with the performance 
objectives (both preclosure and postclosure performance standards) 
contained in Subparts E, K, and L. The Commission could consider the 
QA program, personnel training program, emergency plan and operating 
procedures, among others, in order to determine whether it has 
confidence that there is no unreasonable risk to the health and 
safety of the public. To avoid any misunderstanding and to achieve 
consistency with final EPA standards, the Commission has decided to 
adopt EPA's preferred criterion of ``reasonable expectation'' for 
purposes of judging compliance with the postclosure performance 
objectives. The Commission is satisfied that a standard of 
``reasonable expectation'' allows it the necessary flexibility to 
account for the inherently greater uncertainties in making long-term 
projections of a repository's performance. The Commission agrees 
with EPA and others that it is important to not exclude important 
parameters from assessments and analyses simply because they are 
difficult to precisely quantify to a high degree of confidence. By 
adopting what EPA has characterized as a more flexible standard of 
``reasonable expectation'' for determining compliance with 
postclosure performance objectives, the Commission hopes to make 
clear its expectations. The Commission expects that the required 
analyses of postclosure performance will focus on the full range of 
defensible and reasonable parameter distributions, and that they 
should not be constrained only to extreme physical situations and 
parameter values. For other determinations regarding compliance of 
the repository with preclosure objectives, the Commission will 
retain a standard of ``reasonable assurance,'' consistent with its 
practice for other licensed operating facilities subject to active 
licensee oversight and control.
* * * * *
    As stated previously, in order to avoid further misunderstanding 
of its intent, the Commission will adopt EPA's preferred standard of 
``reasonable expectation'' for purposes of judging compliance with 
the numerical postclosure performance objectives. However, the 
Commission wants to make clear that its proposed use of ``reasonable 
assurance'' as a basis for judging compliance was not intended to 
imply a requirement for more stringent analyses (e.g., use of 
extreme values for important parameters) or for comparison with a 
potentially more stringent statistical criteria (e.g., use of the 
95th percentile of the distribution of the estimate of dose).

    No changes have been made to the Yucca Mountain Review Plan as a 
result of this comment.

11 Other Comments

11.1 Codes and Standards

    Issue: Should the Yucca Mountain Review Plan identify specific 
codes and standards to be used by the applicant?
    Comment. One commenter stated that the draft Yucca Mountain Review 
Plan refers to codes and standards that are not compatible with the 
risks from a geologic repository. The commenter recommended that the 
Yucca Mountain Review Plan be revised to clarify that the applicant has 
the flexibility to use codes, standards, and methodologies it 
demonstrates to be applicable. Another commenter noted that some 
referenced codes and standards were outdated.
    Commenters identified locations in the draft Yucca Mountain Review 
Plan related to their concerns.
    Response. The risk-informed, performance-based regulations at 10 
CFR part 63 give the applicant the responsibility to select codes, 
standards, and methodologies; demonstrate that they are appropriate for 
use with a geologic repository for high-level waste; and then use them 
appropriately. When specific codes, standards, or methodologies were 
listed in the Yucca Mountain Review Plan, they were included only as 
examples or to indicate the kinds of approaches that have been 
successfully used in other licensing programs.
    The Yucca Mountain Review Plan has been revised to clarify that 
references to specific codes, standards, methodologies, or outdated 
codes have been deleted.

11.2 General Comments on the License Application and the Licensing 
Process

    Issue 1: Will NRC ignore mistakes in a DOE license application?
    Comment. Two commenters asked whether NRC would ignore mistakes in 
DOE's license application and how the Commission would address major 
problems in DOE's work. One commenter also stated that NRC must have 
the power to reject a license application.
    Response. A DOE license application must demonstrate compliance 
with applicable regulations. Editorial mistakes that prevent NRC from 
understanding the compliance demonstration may have to be corrected. 
Technical mistakes could even invalidate a DOE analysis to demonstrate 
compliance. The nature, extent, and effects of mistakes in a license 
application would be considered in the NRC review.
    NRC has the statutory authority as well as the responsibility to 
reject a license application if the applicant fails to show that 
applicable regulatory requirements are satisfied.
    No changes to the Yucca Mountain Review Plan were made in response 
to this comment.

[[Page 45114]]

    Issue 2: Does a DOE license application exist?
    Comment. One commenter asked whether a DOE license application 
already existed.
    Response. It is NRC's understanding that DOE had not yet prepared a 
license application.
    No changes to the Yucca Mountain Review Plan were made in response 
to this comment.
    Issue 3: Will NRC hold DOE to appropriate standards in a licensing 
review?
    Comment. One commenter asked whether NRC would hold DOE to the same 
standards that produced failures of high-level waste storage at other 
sites. Other commenters asked whether DOE's past research, 
organizational structure, and organizational culture would be 
considered in a licensing review for a high-level waste repository at 
Yucca Mountain.
    Response. NRC has promulgated regulatory requirements for a high-
level waste repository at 10 CFR part 63. These regulations require 
protection of public health and safety, and the environment. If DOE's 
license application demonstrates compliance with regulatory 
requirements at 10 CFR part 63, and applicable requirements in 10 CFR 
part 51, for high-level radioactive waste repository at Yucca Mountain, 
NRC staff would recommend issuance of a construction authorization or 
license to receive and possess waste, as appropriate.
    DOE organization and qualifications are addressed in the following 
three sections of the draft Yucca Mountain Review Plan: (i) 4.5.3.1, 
``DOE Organizational Structure as it Pertains to Construction and 
Operation of Geologic Repository Operations Area''; (ii) 4.5.3.2, ``Key 
Positions Assigned Responsibility for Safety and Operations of Geologic 
Repository Operations Area''; and (iii) 4.5.3.3, ``Personnel 
Qualifications and Training Requirements.'' A licensing review using 
these sections of the Yucca Mountain Review Plan would support a 
conclusion as to whether DOE may receive a license for a high-level 
waste repository at Yucca Mountain.
    No changes to the Yucca Mountain Review Plan were made in response 
to this comment.
    Issue 4: Will NRC regulations be rewritten to accommodate a Yucca 
Mountain license application?
    Comment. One commenter asked whether NRC would change its 
regulations to accommodate a Yucca Mountain license application. One 
commenter asked whether performance bases are expected to change as 
waste is processed and interred at a repository. Another commenter 
stated that NRC modified the standards for Yucca Mountain because DOE 
could not meet them.
    Response. NRC regulations at 10 CFR part 63 were promulgated to 
specifically address an application for a potential repository at Yucca 
Mountain and were developed through a public rulemaking process. There 
are no plans to revise these regulations.
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.
    Issue 5: What level of conservatism is appropriate in licensing a 
high-level waste repository at Yucca Mountain?
    Comment. One commenter stated the statement in the draft Yucca 
Mountain Review Plan ``Introduction'' (now Appendix A) that NRC cannot 
require a different or additional proposal if the application satisfies 
applicable regulations to encourage an applicant to demonstrate 
compliance using non-conservative methods. The commenter noted that 
this approach is unacceptable for a repository with a disposal period 
of 10,000 years, and that the U.S. Department of Energy should be 
required to use the most conservative approach for demonstrating 
compliance.
    Another commenter expressed the opposite concern that the very 
reliance on the use of ``bounding values'' is not consistent with a 
reasonable expectation compliance standard. The commenter noted that it 
may be necessary to use expert judgement in some cases and that the 
Yucca Mountain Review Plan should explicitly allow use of such 
judgement, or other accepted techniques, in certain circumstances. The 
commenter suggested that NRC staff adopt an ``expected behavior 
approach'' similar to that used by the commercial nuclear power 
industry, noting the similarities and differences in power reactor and 
repository licensing issues and acknowledging that the time and spatial 
scales for a repository limit the use of direct frequency data. To 
address this concern, the commenter suggested the use of natural 
analogue data, and the collection of data over longer time periods, to 
confirm models.
    The same commenter suggested a dual modeling approach that uses the 
``expected behavior'' model followed by application of conservative 
assumptions in areas where it might be difficult to accurately define 
the expected conditions. The intent would be that a conservative model 
would be used for the licensing decision, while the expected behavior 
model would be used to provide regulatory insight.
    Response. NRC's regulations at 10 CFR part 63, are protective of 
health and safety and the environment. Therefore, ensuring compliance 
with them would protect health and safety and the environment and 
accomplish the mission of NRC.
    Regulation of nuclear facilities requires realistic or reasonably 
conservative approaches that take into account importance to safety, 
technical complexity, and the degree and nature of associated 
uncertainty. These concepts underlie the ``reasonable assurance'' and 
``reasonable expectation'' bases that would be applied in NRC staff's 
review of a license application for a high-level waste repository at 
Yucca Mountain.
    The Commission addressed the issue of conservatism in the 
``Statements of Considerations'' for 10 CFR part 63 (66 FR 55732, 
November 2, 2001). In ``Statements of Considerations,'' the Commission 
stated, in part

    Confidence that DOE has, or has not, demonstrated compliance 
with EPA's standards is the essence of NRC's licensing process * * 
*. The Commission does not believe that NRC's use of ``reasonable 
assurance,'' as a basis for judging compliance compels focus on 
extreme values (i.e., tails of distributions) for representing the 
performance of a Yucca Mountain repository. Further * * * if the 
Commission is called on to make a decision * * * the Commission will 
consider the full record before it. That record will include many 
factors in addition to whether the site and design comply with the 
performance objectives (both preclosure and postclosure performance 
standards) * * * The Commission could consider the QA program, 
personnel training program, emergency plan and operating procedures, 
among others, in order to determine whether it has confidence that 
there is no unreasonable risk to the health and safety of the 
public.
    The Commission is satisfied that a standard of ``reasonable 
expectation'' allows it the necessary flexibility to account for the 
inherently greater uncertainties in making long-term projections of 
a repository's performance. The Commission agrees with EPA and 
others that it is important to not exclude important parameters from 
assessments and analyses simply because they are difficult to 
precisely quantify to a high degree of confidence * * *. The 
Commission expects that the required analyses of postclosure 
performance will focus on the full range of defensible and 
reasonable parameter distributions, and that they should not be 
constrained only to extreme physical situations and parameter 
values. For other determinations regarding compliance of the 
repository with preclosure objectives, the Commission will retain a 
standard of ``reasonable assurance'' consistent with its practice 
for other licensed operating facilities subject to active licensee 
oversight and control.


[[Page 45115]]


    Changes have been made throughout the Yucca Mountain Review Plan, 
as necessary, to ensure that the use of conservatism is clearly stated.
    Issue 6: How should requests for additional information be managed?
    Comment. Commenters expressed concern about the NRC staff goal to 
limit requests for additional information to one round. One commenter 
stated that it is unacceptable for NRC staff to impose such a limit. 
Considering the complexity of issues associated with a potential high-
level waste repository at Yucca Mountain, NRC staff should prepare 
requests for additional information as necessary until the licensing 
information is adequate. One commenter stated that DOE's performance 
record implies that one round will not be sufficient and asked (1) If a 
limited number of requests for additional information would be allowed 
and (2) if NRC would allow DOE to submit an incomplete license 
application and then tell it how to make it acceptable. Another 
commenter asked for information on how DOE's responses to requests for 
additional information would be addressed.
    Response. Imposing a limit of one round of requests for additional 
information is not necessary. The Yucca Mountain Review Plan does not 
impose such a limit, but provides guidance that the goal is to complete 
an effective review with only a single round of requests for additional 
information. This is a goal in other NRC regulatory programs as well.
    DOE responses to requests for additional information would be 
evaluated during the NRC licensing review.
    The Yucca Mountain Review Plan has been revised to clarify that 
preparing a single round of requests for additional information is a 
goal for the licensing review.
    Issue 7: Is there a timing constraint on the NRC licensing review 
and preparation of a safety evaluation report?
    Comment. One commenter stated that it would be premature to publish 
a draft safety evaluation report before the licensee has produced the 
information necessary for a license. The commenter went on to state 
that early publication of a safety evaluation report would indicate a 
rush to judgement before necessary information is available. Two 
commenters questioned the schedule for a high-level waste repository 
licensing review. One commenter asked when the 3-year time limit 
begins. Another commenter noted that DOE should be prepared for one or 
more application rejections if the application is inadequate and that 
the licensing process could require several 3-year cycles.
    Response. The NRC detailed technical licensing review begins after 
the license application is found acceptable for review and is docketed. 
NRC plans to decide whether to docket the tendered application within 
90 days from the receipt of the license application. If the license 
application is incomplete and not sufficient to support a detailed 
technical review, the application could be rejected or DOE could be 
informed of the deficiencies and given an opportunity to correct them. 
If DOE is unable to correct them within a reasonable period, the 
license application could be rejected. Section 114 of the Nuclear Waste 
Policy Act requires the Commission to issue a final decision approving 
or disapproving the issuance of a construction authorization not later 
than the expiration of three years after the date of submission of an 
application. A one-year extension from Congress may be requested by the 
NRC.
    Preparation of a safety evaluation report depends on whether NRC 
staff has reached conclusions regarding whether the applicant has 
satisfied applicable regulatory requirements. The entire detailed 
licensing review need not be complete before NRC staff may begin 
preparation of the safety evaluation report. Conclusions on compliance 
with discrete regulatory requirements may be possible early in the 
review period and associated portions of the safety evaluation report 
may be prepared if those conclusions can be independently reached. 
Conclusions related to regulatory requirements that require complex, 
multidisciplinary, or integrated assessment may not be possible until 
late in the licensing review and would be documented in a safety 
evaluation at that time.
    A safety evaluation report could conclude that a license should not 
be granted. In any event, a draft safety evaluation report, if 
published, would not contain final NRC staff conclusions on regulatory 
compliance and would be subject to revision.
    The Yucca Mountain Review Plan text has been modified, as 
necessary, to clarify provisions regarding preparation of a safety 
evaluation report.
    Issue 8: Would a license for a high-level waste repository at Yucca 
Mountain include an option to store wastes temporarily?
    Comment. One commenter asked whether a license for a high-level 
waste repository at Yucca Mountain would include an option to store 
wastes temporarily.
    Response. Since the NRC has not yet received a license application 
for a high-level waste repository at Yucca Mountain, it would be 
speculation to state whether the license would authorize temporary 
storage of wastes.
    No changes have been made to the Yucca Mountain Review Plan in 
response to this comment.
    Issue 9: What would be the term of a license for a high-level waste 
repository at Yucca Mountain and would the license be renewable?
    Comment. One commenter asked that NRC define the period over which 
a license for a high-level waste repository at Yucca Mountain would be 
in effect and to state whether license renewal would be allowed.
    Response. Requirements for issuance of a license for a high-level 
waste repository at Yucca Mountain are specified in 10 CFR part 63, 
subpart B. There are no provisions for renewal of a license. Rather, 
unless such a license is revoked or suspended, it would be in effect 
until an application for license termination satisfies the requirements 
of 10 CFR 63.52(c). At that time, NRC would terminate the license and 
NRC oversight of the site would end.
    No changes have been made to the Yucca Mountain Review Plan in 
response to this comment.
    Issue 10: Would a licensing review conducted using the Yucca 
Mountain Review Plan adequately consider available information about 
the Yucca Mountain site?
    Comment. Two commenters expressed several concerns regarding the 
potential for and effects of the Yucca Mountain site failing to perform 
properly. The commenters noted a concern, shared by farmers in Amargosa 
Valley, that the potential damage from contaminated groundwater to the 
agricultural resource in well-irrigated land around Yucca Mountain has 
not been adequately evaluated, especially considering that the 
population is expected to double in 40 years.
    The commenters stated that DOE ignored results of water surveys, by 
Lawrence Livermore National Laboratory, that proved the existence of 
interbasin groundwater flow from an aquifer under Yucca Mountain to the 
water supplies for Los Angeles and Las Vegas.
    In a related concern, one commenter stated that DOE scientists had 
objected to the recent Yucca Mountain site recommendation because they 
needed at least six more years to complete enough scientific work to 
make a responsible rejection or recommendation. The commenter also 
urged that NRC consider the concerns of the Nuclear

[[Page 45116]]

Waste Technical Review Board, and Dr. Victor Gilinsky that deep 
geologic disposal of nuclear waste carries with it the possibility of 
irretrievable and irremediable error. The commenter stated that NRC, 
under the Nuclear Waste Policy Act, should reject the license 
application, because Yucca Mountain is unsuitable as a repository site 
because of water issues and earthquakes.
    Response. NRC will evaluate the information submitted in a license 
application and any accompanying documents to determine whether the 
application satisfies regulatory requirements, i.e., whether health and 
safety, and the environment will be protected. The regulations in 10 
CFR part 63 and 10 CFR part 51 are protective of health and safety and 
the environment.
    No changes have been made to the Yucca Mountain Review Plan in 
response to this comment.
    Issue 11: Have the key technical issues related to the Yucca 
Mountain site been omitted from the scope of the Yucca Mountain Review 
Plan?
    Comment: Two commenters expressed concern that the key technical 
issues that were supposed to be addressed by DOE have been omitted from 
the Yucca Mountain Review Plan.
    Response. Nine key technical issues which were identified during 
the prelicensing consultation period are largely centered on individual 
scientific or engineering disciplines. The Yucca Mountain Review Plan 
has 14 physical processes (called model abstractions) that NRC staff 
considers most important to health and safety. These 14 model 
abstractions are multidisciplinary and are derived from the 
uncertainties associated with the key technical issues.
    NRC staff would use these 14 model abstractions as the foundation 
for conducting its assessment of DOE's performance assessment during a 
licensing review. Therefore, the portion of the Yucca Mountain Review 
Plan that examines postclosure performance has been structured around 
these abstractions. Technical concerns associated with the key 
technical issues have been incorporated in the model abstractions.
    No changes to the Yucca Mountain Review Plan have been made in 
response to this comment.
    Issue 12: Is there a difference between requests for additional 
information prepared during an acceptance review and those prepared 
during a detailed technical review?
    Comment. One commenter noted that Section 1.2.1, ``Acceptance 
Review Objectives,'' (now Appendix A, Section A1.2.1) of the Yucca 
Mountain Review Plan directs NRC staff to identify additional 
information needed to make the application complete. The commenter 
noted that Section 1.2, ``General Review Procedure,'' (now Appendix A, 
Section A1.2) states that gaps in information necessary to make a 
licensing conclusion should serve as the basis for NRC staff requests 
for additional information. The commenter asked if there are 
differences between these two types of information needs.
    Response. These two types of information request have slightly 
different purposes. Requests for information stemming from an 
acceptance review generally would identify deficiencies in the 
application and ask the DOE to provide information that would make a 
license application complete enough to begin a detailed technical 
review. Examples might be missing maps of facility structure locations 
or missing historical meteorological data.
    Requests for additional information prepared during detailed 
technical review would provide NRC staff with sufficient information to 
determine whether regulatory requirements have been met.
    No changes were made to the Yucca Mountain Review Plan as a result 
of this comment.
    Issue 13: How can information from prelicensing interactions be 
used during a licensing review for a high-level waste repository at 
Yucca Mountain?
    Comment. One commenter noted that the many years of DOE and NRC 
prelicensing interactions have given NRC a considerable opportunity to 
review the breadth and depth of DOE's work related to a Yucca Mountain 
repository. The commenter suggested that the Yucca Mountain Review Plan 
explicitly recognize the progress made during prelicensing reviews and 
communicate the extent to which NRC staff should consider the results 
of these prelicensing interactions.
    Response. During prelicensing issue resolution activities with DOE, 
NRC staff has become knowledgeable about technical issues associated 
with the repository and prepared to conduct a licensing review. No 
licensing decisions have been reached during prelicensing interactions. 
NRC staff will conduct a licensing review for a proposed high-level 
waste repository at Yucca Mountain and make findings based on the 
information and compliance demonstrations presented in the license 
application and any other information submitted by DOE.
    No changes have been made to the Yucca Mountain Review Plan in 
response to this comment.
    Issue 14: Will NRC staff have adequate resources to conduct a 
licensing review for a potential high-level waste repository at Yucca 
Mountain?
    Comment. One commenter expressed concern regarding whether NRC 
staff would have adequate numbers of qualified staff to conduct a 
licensing review for a potential high-level waste repository at Yucca 
Mountain. Other commenters expressed concerns that NRC would be unable 
to obtain qualified reviewers or that all qualified reviewers would 
retire by the time a license application is submitted.
    Response. NRC is taking steps to ensure that it has qualified staff 
sufficient to conduct a licensing review for a potential high-level 
waste repository at Yucca Mountain.
    No changes have been made to the Yucca Mountain Review Plan in 
response to this comment.
    Issue 15: Are requirements on DOE for data traceability, 
transparency, retrievability, reproducibility, and consistency 
adequate?
    Comment. One commenter raised several concerns related to 
requirements on DOE for data traceability, transparency, 
retrievability, reproducibility, and consistency. These concerns 
included: (i) Whether the license application would be hypertext linked 
to supporting documentation; (ii) whether access to DOE data tracking 
numbers is adequate; (iii) whether reference materials are kept updated 
and interrelated; (iv) whether historically defined quality system 
weaknesses are to be corrected; (v) whether data can be located; (vi) 
whether calculation or modeling results can be duplicated; and (vii) 
whether adequate technical bases will be available. The commenter 
suggested the use of DOE ``road maps,'' to help resolve these concerns.
    Response. There is a publicly available record of NRC and DOE 
interactions during the prelicensing consultations on the commenter's 
concerns. Responses to similar comments on the Quality Assurance 
Program section of the Yucca Mountain Review Plan are addressed in 
response to issues above. Separate guidance is under development 
addressing the usage of hyperlinks in the license application.
    NRC staff will continue to observe DOE's quality assurance program 
and will require compliance with quality assurance requirements in 10 
CFR part 63, subpart G, ``Quality Assurance

[[Page 45117]]

Program'' during the license application review.
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.
    Issue 16: What are the penalties for exceeding radiation exposure 
limits?
    Comment. One commenter asked what the penalties would be for 
exceeding radiation protection limits. The commenter also asked for the 
criteria for revocation of a repository license.
    Response. NRC has a rigorous inspection and enforcement program for 
licensed facilities. The enforcement program reflects a hierarchy of 
violations and penalties based on the severity of a violation. 
Depending on the circumstances, enforcement actions could include the 
imposition of civil penalties or revocation of a license. If warranted, 
violations would be referred to the U.S. Department of Justice for 
prosecution. Information on the NRC inspection program can be obtained 
by visiting NRC's Web site at http://www.nrc.gov.
    No changes were made to the Yucca Mountain Review Plan as a result 
of this comment.
    Issue 17: What enforcement action will be taken if the DOE violates 
NRC regulations?
    Comment. One commenter asked whether the Yucca Mountain Review Plan 
states the actions NRC would take if DOE violated regulations or was 
untruthful.
    Response. The Yucca Mountain Review Plan is guidance for the NRC 
staff review of a DOE license application and does not address possible 
enforcement actions. Pursuant to 10 CFR 63.10, information provided to 
NRC, or required to be maintained by law, by a license, or license 
applicant, must be complete and accurate in all material aspects. 
Deliberate violations of NRC requirements are addressed in 10 CFR 
63.11. Enforcement action depends on the severity of a violation and 
could range from issuance of a notice of violation to the issuance of 
an order to impose a civil penalty (or to modify, suspend, or revoke a 
license), or other appropriate action.
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.
    Issue 18: What would be the extent of NRC on-site presence at the 
repository and the NRC staff role after the licensing process?
    Comment. One commenter stated that NRC should provide personnel for 
site monitoring on a continuous basis from the time the Yucca Mountain 
project starts until it is completed. The commenter also asked whether 
NRC staff conducted unexpected on-site inspections during the various 
stages of a project. One commenter asked that NRC staff specify its 
role after the licensing process.
    Response. The Commission discussed the nature of its on-site 
activities at Yucca Mountain in its ``Statement of Considerations'' for 
10 CFR part 63 (66 FR 55768, November 2, 2001) by stating:

    The NRC maintains a local onsite representative's office, with a 
small staff, in Las Vegas, Nevada, as a means of keeping abreast of 
DOE activities and interacting with other stakeholders. This office 
allows our onsite representatives physical proximity to the site and 
the opportunity to interact on various site characterization 
activities. At this time, the NRC has no plans to expand the size of 
the onsite representative's office. However, the size of the office, 
as well as the scope of NRC's activities conducted there, is [are] 
subject to reexamination.

    If a license is granted for a high-level waste repository at Yucca 
Mountain, NRC staff will carry out its statutory and regulatory 
responsibilities to ensure adequate protection of health and safety, to 
promote the common defense and security, and to protect the 
environment. NRC staff plans to have onsite representatives based in 
Las Vegas, Nevada, and would implement an inspection program that would 
continue for the operational lifetime of a repository. These measures 
are similar to those employed at other nuclear facilities.
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.
    Issue 19: What is NRC staff's plan if it cannot complete the 
licensing review for a high-level waste repository at Yucca Mountain 
within the legally mandated time frame?
    Comment. One commenter asked whether NRC staff had a plan for the 
possibility that it might not complete a Yucca Mountain licensing 
review within the legally mandated time frame.
    Response. NRC staff plans to complete its review of an application 
for a proposed repository at Yucca Mountain in sufficient time to 
enable the Commission to decide whether to issue a construction 
authorization within the legally mandated three-four year time frame. 
If additional time is needed to fully consider issues raised in the 
adjudicatory proceeding, NRC will seek appropriate relief.
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.
    Issue 20: How will NRC staff handle a change to repository design 
or operations during the licensing proceeding?
    Comment. One commenter asked how NRC staff would respond if, during 
the licensing process, DOE requested more space for a larger repository 
footprint.
    Response. NRC response to this hypothetical situation would depend 
on whether the change was encompassed by the analysis in the license 
application and was addressed in the environmental impact statement. 
NRC would expect DOE to revise or supplement its application to address 
such changes. NRC would then determine whether the application, as 
revised, satisfies regulatory requirements.
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.
    Issue 21: Why would radioactive wastes be generated during 
operations at a high-level waste repository at Yucca Mountain?
    Comment. One commenter expressed concern that NRC is expecting DOE 
to reprocess spent fuel or to operate a nuclear reactor at a Yucca 
Mountain repository. The commenter cites a portion of Review Method 1 
in the draft Yucca Mountain Review Plan, Section 4.1.1.6, 
``Identification of Structures, Systems, and Components Important to 
Safety, Safety Controls, and Measures to Ensure Availability of the 
Safety Systems,'' which notes that a license application must include 
adequate consideration of ``* * * means to control radioactive waste 
and radioactive effluents * * * such as: * * * liquid waste management 
system to handle the expected volume of potentially radioactive liquid 
waste generated during normal operations * * *.'' The commenter stated 
that the public does not expect the Yucca Mountain site to be 
generating radioactive waste during normal operations and asked if 
there was another explanation for this review method.
    Response. A license for a geologic repository at Yucca Mountain 
would not authorize the reprocessing of spent fuel or operation of a 
nuclear power reactor at the site. Experience from other nuclear 
facilities where high-level radioactive waste and spent fuel handling 
and packaging take place, however, indicates that small amounts of 
radioactive waste (e.g., gloves) will be generated during fuel 
handling, packaging, testing, and decontamination activities. These 
materials generally may be classified as low-level waste and would be 
disposed of appropriately. This review method addresses a regulatory 
requirement at 10 CFR 63.112, ``Requirements for Preclosure Safety 
Analysis of the Geologic

[[Page 45118]]

Repository Operations Area,'' Subsection (e)(10), which requires an 
analysis that includes ``* * * means to control radioactive waste and 
radioactive effluents, and permit prompt termination of operations and 
evacuation of personnel during an emergency * * *.''
    No changes were made to the Yucca Mountain Review Plan as a result 
of this comment.
    Issue 22: Would emergency response capability to respond to 
potential radiological accidents at a high-level waste repository at 
Yucca Mountain be adequate?
    Comment. One commenter expressed several concerns regarding 
emergency response planning including: (i) Whether local emergency 
response personnel would have to be mobilized to respond to radioactive 
waste spills; (ii) whether NRC intends to fund the purchase of 
equipment necessary to neutralize the effects of a radiation spill; 
(iii) whether NRC will educate the public on self-protection during 
radiation emergencies; and (iv) whether drills would be conducted for 
evacuation of a large population threatened by radiation exposure.
    Response. The Commission addressed issues related to emergency 
preparedness and response in its ``Statement of Considerations'' for 10 
CFR part 63 (66 FR 55745-55746, November 2, 2001) as follows:

    Part 63 (Subpart I) requires DOE to submit an emergency plan for 
coping with radiological accidents. NRC's review of DOE's emergency 
plan will evaluate the adequacy of the plan including such things as 
the capability to respond to accidents and medical assistance for 
treatment of radiological injuries. Where DOE's emergency plan is 
found to be inadequate, NRC, if necessary, can impose license 
conditions that require DOE to correct any deficiencies. * * *
    Additionally, U.S. Federal Emergency Management Agency (FEMA) 
regulations, as well as DOE orders, require that DOE have an 
emergency response capability that is adequate to meet anticipated 
accidents, including potential radiological accidents. DOE is 
responsible for ensuring that the emergency treatment capability 
exists and is documented in its emergency plan, which is subject to 
NRC review in accordance with Section 63.161.

    In response to a comment regarding the required scope of emergency 
plans the Commission stated (66 FR 55746, November 2, 2001):

    The rule requires DOE to have plans to cope with radiological 
accidents (emergency planning at section 63.161) and provide for 
physical protection (Section 63.21(b)(3)). These plans are required 
to address a number of criteria to ensure that DOE is prepared to 
respond, both on site and off site, to accidents, and that DOE has 
the capability to detect and respond to unauthorized access and 
activities that could threaten the physical protection of high-level 
waste. As noted * * *, NRC and [U.S. Federal Emergency Management 
Agency] regulations, as well as DOE orders, require that DOE have 
adequate plans and procedures in place to address any potential 
accidents and incidents. DOE's emergency plan and physical 
protection plan are subject to NRC review. The Commission believes 
that the requirements for DOE's plans for emergencies and physical 
protection expressed in the proposed Part 63 are appropriate and has 
retained them in the final rule. In light of the terrorist attacks 
of September 11, 2001, the Commission has directed the staff to 
conduct a comprehensive reevaluation of NRC physical security 
requirements. If this effort indicates that NRC's regulations or 
requirements warrant revision, such changes would occur through a 
public rulemaking or other appropriate methods.
    Section 63.161 requires DOE to develop an emergency plan based 
on the criteria of Section 72.32 (i.e., criteria provided for an 
Emergency Plan for an Independent Spent Fuel Storage Installation 
(ISFSI)). The required Emergency Plan includes: Identification of 
each type of accident; description of the means of mitigating the 
consequences of each type of accident; prompt notification of 
offsite response organizations; and adequate methods, systems, and 
equipment for assessing and monitoring actual or potential 
consequences of a radiological emergency condition. If particular 
types of accidents require evacuation procedures to ensure the 
protection of public health and safety, they will be included in the 
Emergency Plan.
    Section 63.21(b)(3) requires DOE to submit a detailed plan to 
provide physical protection of HLW in accordance with Sec.  73.51 
(requirements for physical protection of stored spent nuclear fuel 
and HLW). The requirements for physical protection include: (1) 
Capabilities to detect and assess unauthorized access or activities 
and protect against loss of control of the facility; (2) limiting 
access to HLW by means of two physical barriers; (3) providing 
continual surveillance of the protected area in addition to 
protection by an active intrusion alarm; and (4) providing a primary 
alarm station located within the protected area and have [having] 
bullet-resisting walls, doors, ceiling, and floor. These 
requirements provide high assurance that physical protection of the 
repository includes appropriate measures to prevent and respond to 
unauthorized access and activities, including the potential for 
armed intruders (e.g., terrorist activity).

    The Commission also addressed infrastructure requirements for 
emergency response (66 FR 55746, November 2, 2001).

    Section 180(c) of the Nuclear Waste Policy Act requires DOE to 
provide technical assistance and funding for training State and 
local governments and Tribes for safe routine transportation and 
emergency response. However, NRC's responsibility for oversight and 
review of DOE's emergency plans * * * does not include 
responsibility for how DOE provides for technical assistance and 
funding. Additionally, under NEPA, the potential for (environmental) 
impacts due to transportation, including accidents, is the 
responsibility of DOE to assess and mitigate.

    Section 4.5.7, ``Emergency Planning,'' of the draft Yucca Mountain 
Review Plan provides guidance regarding the review of DOE's application 
with respect to emergency planning regulations.
    No changes were made to the Yucca Mountain Review Plan as a result 
of this comment.

11.3 Issue Resolution

    Issue: When will the 293 agreements regarding key technical issues 
be resolved?
    Comment. Commenters asked when the 293 identified unresolved issues 
would be resolved and whether the repository would be licensed if the 
issues were unresolved. One commenter stated that if NRC staff uses the 
technical understanding and basis for issue resolution developed during 
prelicensing, it must explicitly reference to the supporting 
documentation. One commenter was concerned that haste in issue 
resolution would result in some issues not being properly resolved. 
Another commenter stated that DOE's site recommendation is premature 
and that years are still required to amass information necessary for a 
license application. Another commenter asked whether issues identified 
by the U.S. Government Accounting Office would be included in the 
licensing process.
    Response. In 293 agreements with NRC, DOE agreed to provide 
additional information to NRC regarding key technical issues as part of 
the prelicensing issue resolution process. NRC staff expects that this 
prelicensing issue resolution will continue up to the time that DOE 
submits an application for a construction authorization for a 
repository at Yucca Mountain and that DOE will address the 293 
agreements before submitting the application. During prelicensing 
interactions with DOE, NRC staff has stayed informed on issues related 
to DOE's site characterization and the repository design process and 
identified concerns regarding these issues in public meetings and 
documents. Issues identified by the U.S. Government Accounting Office 
were taken from issues raised by NRC staff.
    NRC staff has made clear that a licensing decision will be based on 
information contained in the DOE application. Issues may be reopened, 
or new issues may be identified, during the

[[Page 45119]]

review of the license application. A construction authorization for a 
repository at Yucca Mountain will not be issued unless DOE 
demonstrates, and NRC staff determines, that applicable regulatory 
requirements have been met. NRC staff will document the basis for its 
conclusions on the application in a safety evaluation report.
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.

11.4 Public Participation

    Issue 1: What is the public role in activities under the Nuclear 
Waste Policy Act related to Yucca Mountain?
    Comment. Commenters identified approximately 20 questions about the 
nature and extent of public participation in a Yucca Mountain licensing 
proceeding and questioned whether the public participation process was 
valid. Some commenters asked about the extent of public participation 
in the process and others argued that public participation was 
required. One commenter stated expectations that NRC staff will 
adequately advertise public hearings in advance. Another commenter 
stated that all interactions between NRC and DOE should be in public 
meetings or by conference calls that include the public.
    Other commenters urged that there be a continuing program of 
interaction, training, and progress reviews for the public and 
questioned whether the public has adequate access to the Yucca Mountain 
site.
    Response. NRC staff has offered numerous opportunities for the 
public to stay informed about activities related to the proposed 
repository at Yucca Mountain. The extensive program of public 
involvement has included meetings in Nevada on the mission of NRC, the 
development of 10 CFR part 63, the review of DOE's draft environmental 
impact statement, and the development of the Yucca Mountain Review 
Plan. Formal periods of public comment were provided for development of 
10 CFR part 63 and the Yucca Mountain Review Plan. NRC has had public 
interactions with DOE consistent with a prelicensing agreement and the 
Commission's Open Meeting Policy (59 FR 48340, September 20, 1994; 65 
FR 56964, September 20, 2000), and the public has been given the 
opportunity to ask questions. Notice of public meetings with DOE is 
provided in advance and that practice will continue.
    In addition, as required by NRC regulations in 10 CFR part 2, 
``Rules of Practice for Domestic Licensing Proceedings and Issuance of 
Orders,'' an opportunity for a formal adjudicatory hearing will be 
provided on the license application for high-level waste repository at 
Yucca Mountain. Members of the public, including representatives of the 
State of Nevada, local counties, and Indian Tribes, may participate in 
a hearing on the application provided they are admitted as parties or 
interested governmental participants to the proceeding.
    Substantial documentary material related to the license application 
will be available to the public and participants in the licensing 
proceeding via the Licensing Support Network, which is accessible over 
the Internet, as required by 10 CFR part 2, subpart J, ``Procedures 
Applicable to Proceedings for the Issuance of Licenses for the Receipt 
of High-Level Radioactive Waste at a Geologic Repository.''
    If the Yucca Mountain Review Plan is revised or updated in the 
future, NRC will decide, depending on the nature and extent of the 
changes, whether to circulate it for public comment.
    No changes were made to the Yucca Mountain Review Plan in response 
to these comments
    Issue 2: What assistance will NRC staff provide to Native American 
Tribes with respect to the licensing of the potential high-level waste 
repository at Yucca Mountain?
    Comment. A commenter stated that NRC staff was not interested in 
helping or working with members of Native American Tribes and asked 
that the hearing process be extended for 10-15 years to enable tribal 
members to prepare to participate in the proceeding.
    Response. NRC recognizes the unique status of Native American 
Tribes. Consistent with the Nuclear Waste Policy Act, NRC regulations 
in 10 CFR part 63, subpart C, require that any ``affected Indian 
Tribe'' (a status conferred by the Department of the Interior) be kept 
informed concerning activities regarding the proposed repository and 
also provide opportunities for affected Indian Tribes to participate in 
the review of the license application under certain circumstances. 
Further, as noted in response to Issue 1, above, Indian Tribes may also 
seek permission to participate in the adjudicatory proceeding pursuant 
to 10 CFR part 2, subpart J.
    As a general matter, representatives of Indian Tribes, as well as 
other members of the public, have been notified of public interactions 
concerning the proposed repository and have had access to the Yucca 
Mountain Review Plan and other documents related to the repository.
    The requested, lengthy extension of the hearing process would be 
inconsistent with three- to four-year statutory deadline for a NRC 
decision on the construction authorization for the proposed repository.
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.

11.5 U.S. Department of Energy Responsibilities

    Issue 1: What are DOE's responsibilities at the proposed 
repository?
    Comment. One commenter asked whether DOE would be allowed to 
transfer responsibilities and liabilities to corporate vendors.
    Response. Under NRC regulations, the license applicant or licensee 
is responsible for safety and regulatory compliance with NRC 
regulations, even if some activities are performed by a contractor. 
Thus, DOE is responsible for ensuring that the proposed repository is 
constructed, and waste handling and disposal activities are conducted, 
in compliance with NRC requirements, NRC will conduct the necessary 
inspection and review activities to determine compliance with NRC 
regulations, and take action, as necessary, to enforce those 
requirements, including modifying, suspending or revoking any license 
issued, if warranted.
    No changes to the Yucca Mountain Review Plan were made in response 
to this comment.
    Issue 2: Who is financially responsible for the safe operation of a 
repository?
    Comment. One commenter asked who would be financially responsible 
for limiting radioactive release from the repository. Another commenter 
expressed concern that the costs of cleaning up after an accident or 
sabotage would be astronomical and asked who would be responsible for 
these costs. Another commenter stated that there are no stewardship 
funds for Yucca Mountain.
    Response. Federal statutes provide that DOE would be licensed by 
NRC, if appropriate, to construct and operate the high-level waste 
repository at Yucca Mountain. Thus, DOE, an agency of the Federal 
Government, would be financially responsible for ensuring that 
activities at the repository are conducted safely.
    As the Commission stated in its ``Statement of Considerations'' for 
10 CFR part 63 (66 FR 55771, November 2, 2001):

    Part 63 does not alter whatever liability the Federal Government 
may have for damage to

[[Page 45120]]

health or property caused by its activities. It is possible that 
compensation could be available for certain types of damage to 
health or property under Federal law, but it would be speculative to 
suggest that compensation would be available in any particular case.

    No changes to the Yucca Mountain Review Plan were made in response 
to this comment.
    Issue 3: How does DOE provide material control and accountability 
for nuclear materials at the Nevada Test Site?
    Comment. One commenter asked about the material control and 
accounting by DOE at the Nevada Test Site.
    Response. The Nevada Test Site is under DOE jurisdiction and is not 
regulated by NRC. The commenter should contact DOE for information 
regarding material control and accounting at the Nevada Test Site.
    No changes were made to the Yucca Mountain Review Plan as a result 
of this comment.
    Issue 4: Who is responsible for identifying structures, systems, 
and components important to safety?
    Comment. One commenter expressed concern that the Yucca Mountain 
Review Plan directs that NRC staff should focus its review 
proportionally on high-risk-significant structures, systems, and 
components important to safety. The commenter argued that NRC, as the 
regulator, should not defer to DOE judgments as to which components are 
most important to safety, and should perform a separate analysis of 
what the Commission views as high-risk-significant structures, systems, 
and components important to safety.
    Response. Regulations at 10 CFR 63.142(c)(1) require DOE to 
identify the structures, systems, and components to be covered by the 
quality assurance program. DOE must identify structures, systems, and 
components important to safety or to waste isolation and to assess 
their risk significance. NRC will evaluate whether DOE has adequately 
performed this identification and assessment.
    Commensurate with implementation of risk-informed, performance-
based regulation for a high-level waste repository, NRC staff would 
focus its review proportionately on those structures, systems, and 
components that are important.
    NRC staff has developed an independent capability to conduct a 
preclosure safety analysis. Consistent with risk-informed, performance-
based regulation, this independent capability will be focused on those 
structures, systems, and components important to health and safety.
    No changes were made to the Yucca Mountain Review Plan as a result 
of this comment.

11.6 Role of the Licensing Support System Advisory Review Panel (Now 
the Licensing Support Network Advisory Review Panel)

    Issue: What is the role of the Licensing Support Network Advisory 
Review Panel in the review of licensing issues?
    Comment. One commenter asked whether the Licensing Support System 
Advisory Review Panel (now the Licensing Support Network Advisory 
Review Panel) will continue to perform a review role on licensing 
issues.
    Response. Under 10 CFR 2.1011(e), the Licensing Support Network 
Advisory Review Panel provides advice to NRC on issues related to, 
among other things, the type of computer system necessary to access the 
Licensing Support Network, and computer format standards for providing 
electronic access to the documentary material made available via the 
Licensing Support Network, and procedures and formats for electronic 
transmission of filings and orders in the adjudicatory proceeding on 
the DOE application. The Licensing Support Network Advisory Review 
Panel basically provides advice on issues related to the means by which 
information about the proposed high-level waste repository will be made 
electronically available and has no role in the review of DOE's 
application.
    No changes have been made to the Yucca Mountain Review Plan in 
response to this comment.

11.7 The U.S. Department of Energy Environmental Impact Statement

    Issue: How will the Yucca Mountain Review Plan provide for review 
of a Yucca Mountain environmental impact statement?
    Comment. Several commenters questioned whether the Yucca Mountain 
Review Plan adequately addressed review of the Yucca Mountain 
environmental impact statement.
    Some commenters questioned the adequacy of the environmental impact 
statement in evaluating property values along the transportation 
routes, flooding analysis, environmental justice, cumulative effects, 
impacts on affected Native American Tribes (economic, cultural, and 
social) and responses to public comments on the environmental impact 
statement.
    Other commenters recommended modification of the environmental 
impact statement to incorporate designs presented in the license 
application, the preparation of a Record of Decision, and any need to 
prepare a supplemental environmental impact statement.
    Response. Comments regarding DOE's Final Environmental Impact 
Statement are not related to the Yucca Mountain Review Plan, which is a 
guidance document for NRC staff to use to conduct a review of whether 
the DOE license application, if submitted, satisfies NRC regulations in 
10 CFR part 63.
    Under Section 114 of the Nuclear Waste Policy Act, NRC (in 
connection with the issuance of a construction authorization and 
license for a repository) is required to adopt, to the extent 
practicable, any environmental impact statement prepared in connection 
with a repository. If the DOE submits an application, NRC staff would 
publish a notice of hearing in the Federal Register and state whether 
it is practicable to adopt DOE's environmental impact statement. The 
notice would provide a 30-day opportunity for parties and petitioners 
to file contentions regarding whether it is practicable to adopt the 
environmental impact statement. The presiding officer in the hearing 
would rule on any petition to intervene and, to the extent raised by an 
admitted contention, resolve disputes concerning NRC staff 
determination regarding adoption of the environmental impact statement. 
The decision of the presiding officer would be reviewable by the 
Commission.
    The standards, set forth in 10 CFR 51.109(c), require that NRC find 
it practicable to adopt any environmental impact statement prepared by 
DOE unless: (1) The action proposed to be taken by the Commission 
differs from the action proposed in the DOE license application and 
this difference may significantly affect the quality of the human 
environment, or (2) Significant and substantial new information or new 
considerations render DOE's final environmental impact statement 
inadequate.
    Unless either of the above criteria were met, NRC would find it 
practicable to adopt the environmental impact statement.
    No changes were made to the Yucca Mountain Review Plan were made in 
response to these comments.

11.8 Transportation

    Issue: Are transportation concerns, including protection of nuclear 
materials during transport, adequately addressed in the Yucca Mountain 
Review Plan?

[[Page 45121]]

    Comments. Several commenters identified issues relating to U.S. 
Department of Transportation and NRC transportation regulations and the 
adequacy of DOE's Environmental Impact Statement in evaluating the 
transportation of storage casks to a geologic repository at Yucca 
Mountain.
    A number of commenters also expressed concerns about physical 
protection and security during transport of nuclear materials from 
current storage locations to Yucca Mountain.
    Response. The Yucca Mountain Review Plan is guidance for NRC staff 
in conducting a review of the license application submitted under 10 
CFR part 63. Reviews of transportation of nuclear materials is 
addressed by other NRC guidance. Section 180 of the Nuclear Waste 
Policy Act, 42 U.S.C. 10175, requires DOE to use NRC-certified package 
designs to transport spent nuclear fuel and high-level waste to a 
permanent geologic repository. The design of casks that would be used 
by DOE to transport spent nuclear fuel to a proposed repository must be 
reviewed and approved by NRC in accordance with 10 CFR part 71. The 
applicable NRC review guidance is in NUREG-1617, the ``Standard Review 
Plan for Transportation Packages for Spent Nuclear Fuel.'' If and when 
DOE submits a design, or designs, for shipping casks, NRC would perform 
a safety review, and if the designs are found to comply with NRC 
regulations, then NRC would issue a Certificate of Compliance that is a 
license to use the cask(s) for shipping the specified fuel contents.
    Review of transportation activities for Yucca Mountain will depend 
on whether they will be conducted by an NRC licensee other than DOE. If 
DOE takes custody of spent fuel at the site of an NRC licensee, DOE 
regulations would govern the security of spent fuel shipments. If an 
NRC licensee ships spent fuel to the geologic repository, 10 CFR part 
71, 10 CFR part 73, and U.S. Department of Transportation regulations 
apply. The impacts of transportation to and from the facility have been 
evaluated in the DOE environmental impact statement that may be adopted 
by NRC under 10 CFR 51.109.
    NRC's regulations for physical protection of the shipment of 
irradiated reactor fuel (i.e., spent nuclear fuel) by NRC licensees are 
located in 10 CFR 73.37. Shipments made by NRC licensees to a future 
high-level waste repository would be subject to NRC security 
regulations. NRC staff would review the proposed routes for shipments. 
For shipments that are subject to NRC's authority, the regulations in 
10 CFR 73.37 require licensees to develop and implement security 
procedures to meet performance objectives, including minimizing the 
possibilities for radiological sabotage. These procedures provide 
information on how licensees comply with NRC's spent nuclear fuel 
shipment physical protection requirements, including advance 
notification of each shipment to Governors, the establishment of 
redundant communication capability with the shipment vehicle, the 
arrangement of law enforcement contacts along the route, and provisions 
for armed escorts. Section 180 of the Nuclear Waste Policy Act requires 
DOE to abide by NRC's advance notifications to state and local 
governments associated with transporting spent fuel and high level 
waste.
    For NRC-licensed shipments, NRC reviews and approves in advance the 
routes used for road and rail shipments of irradiated reactor fuel, 
with respect to physical protection requirements. The U.S. Department 
of Transportation regulations at 49 CFR part 397 establish the 
requirements for the designation of preferred routes for highway 
shipment of hazardous material (e.g., spent nuclear fuel). A shipper 
must choose routes that meet U.S. Department of Transportation-
specified criteria that are intended to minimize the risk of exposure 
of the public to radiation. There is no formal U.S. Department of 
Transportation route approval processes as long as routes are 
consistent with U.S. Department of Transportation guidelines. The U.S. 
Department of Transportation regulations set the standards for 
packaging, transporting, and handling radioactive materials (including 
labeling, shipping documents, placarding, loading, and unloading), and 
specify training that is required for personnel who handle and 
transport hazardous materials.
    Since the events of September 11, 2001, NRC has taken actions to 
impose additional security requirements on shippers of spent nuclear 
fuel. In addition, NRC is sponsoring vulnerability studies to determine 
the potential effects on a cask subject to attack, by terrorists, 
beyond current regulatory assumptions, including the crash of a jumbo 
jet filled with fuel. NRC staff would use results of this study to 
determine if its security regulations should be modified.
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.

11.9 Terrorism

    Issue: Does the Yucca Mountain Review Plan adequately address 
terrorism and related acts?
    Comment. One commenter questioned whether NRC staff was going to 
mandate ``mock attack'' drills on the Yucca Mountain site as a test of 
the physical protection system. Another commenter inquired whether NRC 
staff was going to consider protection from insider threats as well as 
the outsider threat to a repository. Other commenters questioned the 
perceived lack of security at nuclear facilities in the wake of the 
September 11, 2001, attacks and argued that the Yucca Mountain site 
would be a prime target for terrorists. A commenter asked that the 
schedule for the U.S. Nuclear Regulatory comprehensive review of 
physical security be placed in the Yucca Mountain Review Plan.
    One commenter stated that the technical bases and assumptions for 
identifying initiating events need to include acts of terrorism, 
sabotage, and acts of war. The same commenter stated that for 
calculating Category 2 event sequences, sabotage in the repository, 
acts of war directed at the repository, sabotage in the operations 
area, acts of war in the operations area, accidental criticality, 
intentional criticality, dirty bombs, and permanent contamination of 
the operations area need to be considered.
    Response. NRC staff has taken actions regarding security at NRC-
licensed facilities in the wake of the September 11, 2001, attacks. 
Numerous security advisories have been issued to site security managers 
keeping them updated on the threat environment. NRC staff monitors the 
threat environment and shares information and analysis with other law 
enforcement and intelligence agencies. Compensatory Measures have been 
issued to NRC licensees outlining mandatory enhancements to physical 
protection in areas such as access control, physical barriers, 
detection, assessment, and response. The Compensatory Measures are 
designed to enhance and strengthen physical protection until the 
Commission-ordered comprehensive review of physical protection is 
complete.
    The purpose of the Yucca Mountain Review Plan is to ensure the 
quality and uniformity of NRC staff licensing reviews under 10 CFR part 
63. The NRC comprehensive review of safeguards and security is a 
separate activity. The NRC safeguards and security review encompasses 
all types of licensed facilities and includes information and

[[Page 45122]]

personnel security programs. Additionally, the review schedule may need 
to be modified based on the changing threat environment. NRC staff 
review of the physical protection aspects of a license application for 
a high-level waste repository at Yucca Mountain would be consistent 
with results from the comprehensive review.
    Protection against terrorism and sabotage were discussed by the 
Commission in the ``Statement of Considerations'' for 10 CFR part 63 
(66 FR 55771, November 2, 2001):

    As regards the potential risk of radiological sabotage to the 
repository during the preclosure phase of operations, the 
Commission's regulations for Yucca Mountain at Section 63.21(b)(3) 
require that licensees have in place adequate physical security 
plans and attendant procedures to protect against radiological 
sabotage, consistent with Section 73.51--NRC's requirements for the 
physical protection of stored spent nuclear fuel and high-level 
radioactive waste. In light of the terrorist attacks of September 
11, 2001, the Commission has directed the staff to conduct a 
comprehensive reevaluation of NRC physical security requirements. If 
this effort indicates that NRC's regulations or requirements warrant 
revision, such changes would occur through a public rulemaking or 
other appropriate methods.

    The physical security plan required by 10 CFR 63.21(b) and 10 CFR 
73.51 would not be made publicly available, but would be reviewed to 
determine whether the regulatory requirements are met.
    The technical bases and assumptions for identifying initiating 
events and evaluating Category 2 event sequences do not need to include 
acts of war. As the Commission stated in issuing 10 CFR part 63 (66 FR 
55776, November 2, 2001), ``[c]onsideration of the effects of wars and 
military actions is beyond the scope of NRC's responsibility. NRC has 
not taken into account the effects of war in developing Part 63.''
    Events such as criticality and contamination of the operations area 
are addressed in responses to other comments.
    No changes were made to the Yucca Mountain Review Plan in response 
to this comment.

11.10 Editorial Comments

    Issue: Will editorial corrections be made to the Yucca Mountain 
Review Plan?
    Comment. Several commenters suggested editorial improvements to the 
Yucca Mountain Review Plan.
    A partial list of these comments follows.
    (1) Remove review plan Section 1, ``Introduction,'' and Section 2, 
``Acceptance Review,'' from the front of the plan and include them as 
appendixes, to avoid detracting from the actual licensing review.
    (2) Change the bullet and dash system to a numerical outline format 
similar to that in other NRC staff guidance documents.
    (3) Clarify the language of Review Method 3 in Section 3.1, 
``General Description,'' of the draft Yucca Mountain Review Plan, 
regarding the basis for the Commission's licensing authority.
    (4) Make specific provisions in the Yucca Mountain Review Plan for 
evaluating information that is classified, such as the characteristics 
of naval fuel.
    (5) Update the Yucca Mountain Review Plan to reflect the current 
status of activities under the Nuclear Waste Policy Act.
    Response. NRC staff has incorporated those editorial comments that 
add clarity to the Yucca Mountain Review Plan.

    Dated at Rockville, Maryland, this 23rd day of July 2003.

    For the Nuclear Regulatory Commission.
Janet R. Schlueter,
Chief, High-Level Waste Branch, Division of Waste Management, Office of 
Nuclear Material Safety and Safeguards.
[FR Doc. 03-19321 Filed 7-30-03; 8:45 am]
BILLING CODE 7590-01-P