# Yucca Mountain Review Plan, NUREG-1804, Revision 2, Final Report > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A03-19321 ## Record - **Collection:** Federal Register - **Document type:** Notice - **Published:** July 31, 2003 - **Citation:** 68 FR 45086 ## Text 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: pdr@nrc.gov . 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: jac3@nrc.gov . 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. 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 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 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. 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 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 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. 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. 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. 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 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 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 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 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 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 (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 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 m [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A03-19321. Public record. Not legal advice.