Detailed Information on the
High-Level Waste Repository Assessment

Developing additional efficiency measures, including the updating of baseline data, to provide a means to systematically measure and monitor efficiencies through tracking labor effort in support of major milestones and establishing targets that demonstrate improved efficiency or cost effectiveness over the previous year.

Developing better linkage of budget requests to the program's success in accomplishing annual and agency long term goals. In reviewing the budget, the program tracks many measures, but there needs to be a clear connection of how funding impacts goal achievement.

Measure: Regulation and guidance necessary to make a decision on DOE's repository license application will be planned and executed such that the decision can be made on time.

Explanation:

Supports Program Safety Goal: Ensure protection of public health and safety and the environment.

Measures the Program's first main prelicensing activity: Establishing a complete and rigorous regulatory framework. Regulations and guidance ensure safety and security by defining criteria that NRC believes will ensure protection of public health, safety and security. Thus, if the Program determines that the repository design and activities comply with the regulations, there will be a reasonable basis to believe it will achieve the agency-wide safety and security performance measures in the future when they become applicable. This measure implements means and strategies in the agency's Strategic Plan: (1) establishing a licensing and regulatory program; and (3) using sound science and risk-informed, performance-based regulations.

New measure in FY 2005.

FY 2005 Target: Submit SECY paper to publish Draft 10 CFR 63

FY 2006 Target: Publish a final 10 CFR Part 63 no more than 6 months after EPA publishes a final revised standard in the Federal Register.

FY 2007 Target: Publish a final 10 CFR Part 63 no more than 6 months after EPA publishes a final revised standard in the Federal Register.

FY 2008 Target: Modify the Yucca Mountain Review Plan no more than 6 months after final 10 CFR Part 63, consistent with EPA's final revised 40 CFR Part 197 published in the Federal Register.

The regulations cited in the targets implement the Energy Policy Act of 1992. EPA is required to promulgate public health and safety standards for Yucca Mountain (designated as 40 CFR Part 197). NRC is required to incorporate these EPA standards into its regulations (designated as 10 CFR Part 63). 10 CFR Part 63 contains the criteria the Program will use in reviewing a DOE license application and thus is the primary regulation used by the Program to accomplish its safety goals.

The FY 2005 target was met. On August 22, 2005, EPA's proposed standard was published in the Federal Register. On August 24, 2005, SECY-05-0144, with the proposed revisions to 10 CFR Part 63, was provided to the Commission. On September 8, 2005, staff published, for public comment, proposed revisions to Part 63.

The FY 2006 target was not applicable since EPA did not publish final revised standards in FY 2006.

Note: This measure is treated as an annual measure in the NRC Performance Budget and previously as an annual measure in the High-Level Waste Repository Safety Division Operating Plan. As explained in Question 2.1, this measure also serves as a long-term measure demonstrating that the Program is making progress in preparing to review a potential DOE license application.

Measure: High-level waste safety technical reviewers are qualified.

Explanation:

Supports Program Safety Goal: Ensure protection of public health and safety and the environment.

Supports Program Effectiveness Goal: Ensure NRC actions are effective, efficient, realistic, and timely.

Measures the Program's second main prelicensing activity: Preparing staff and infrastructure for the review and hearing process. To make good licensing decisions, that would help ensure protection of the public and the environment, if a repository were licensed and began operations by 2017, the Program will need to conduct a thorough, effective, and fair review and hearing by a qualified staff. To conduct a license application review, staff will need to be trained on regulations and guidance as well as developing independent technical expertise. A performance measure is used to evaluate staff training through a formal qualification process for High-Level Waste Safety Technical Reviewers. This measure implements means and strategies in the agency's Strategic Plan: (2) making systematic improvements to the regulatory program; and (3) using sound science and risk-informed, performance-based regulations.

New measure in FY 2004.

FY 2004 Target: Qualify 50% of Reviewers by December 2003.

FY 2005 Target: Qualify 80% of HLWRS Reviewers by December 2004.

FY 2006 Target: Less than five new HLWRS staff members exceed their reviewer qualification target date

FY 2007 Target: Less than five new HLWRS staff members exceed their reviewer qualification target date.

FY 2008 Target: Less than five new HLWRS staff members exceed their reviewer qualification target date.

Qualification is a determination by the Program, based on a staff member's professional background, work experience, education, and training that a staff member has the necessary skills and experience to perform assigned Division of High Level Waste Repository Safety technical review and project management tasks. The process the Program uses to determine a staff member is qualified is described in NRC Inspection Manual Chapter 1246 (IMC 1246), "Formal Qualification Programs in the Nuclear Material Safety and Safeguards Program Area," dated January 5, 2001.

The FY 2006 - 2008 target was chosen to balance the use of Program resources and allow the use of staff for emerging work while preventing the buildup of a group of non-qualified staff. There are approximately 60 technical reviewers in the Program and all the technical reviewers not in the qualification program have already been qualified. In years with limited turnover, the Program determined that 4 technical reviewers represented a reasonable balance of Program resources and delays in technical reviewers becoming qualified. Should the Program staff increase significantly (i.e. add 20 or more staff when a license application is imminent), 4 delayed qualified technical staff is a reasonably small fraction.

The review qualification target date is the date set on a case by case basis for each new staff member considering existing work, availability of training, previous experience, and the prudent use of Program resources.

The FY 2005 target was missed by three months due in part to the need to divert staff resources during a continuing resolution.

Note: This measure is treated as an annual measure in the High-Level Waste Repository Safety Division Operating Plan. As explained in Question 2.1, this measure also serves as a long-term measure demonstrating that the Program is making progress in preparing to review a potential DOE license application.

Measure: Ensure that HLW Meta-System service level requirements for availability and reliability are met, and that information technology information management systems and business processes are in place to support pre-license application, pre-hearing, or hearing activities on the proposed Yucca Mountain repository.

Explanation:

Supports Program Openness Goal: Ensure openness in our regulatory process.

Supports Program Effectiveness Goal: Ensure NRC actions are effective, efficient, realistic, and timely.

Measures the Program's second main prelicensing activity: Preparing staff and infrastructure for a review and hearing process that can be completed 3-4 years after submission of the application or approximately 2012. The high-level waste Meta-System is a collection of information technology systems that support a full electronic hearing, including the electronic submittal and exchange of information. The Meta-System was developed over several years and placed into operation in 2005. The Meta-System is currently being maintained (e.g. keeping the technology up to date) with limited testing to support the limited pre-application hearing activities and ready to fully support licensing activities. This measure implements means and strategies in the agency's Strategic Plan: (2) making systematic improvements to the regulatory program.

New measure in FY 2004.

FY 2004 Target: Resolve information technology and information management issues to keep pace with DOE's schedule.

FY 2005 Target: As appropriate, resolve information technology and information management issues to keep pace with DOE's schedule.

FY 2006 Target: The HLW Meta-System will be operational for the HLW licensing and adjudicatory business process in accordance with established service levels.

FY 2007 Target: The HLW Meta-System will be operational for the HLW licensing and adjudicatory business process in accordance with established service levels.

FY 2008 Target: The HLW Meta-System will be operational for the HLW licensing and adjudicatory business process in accordance with established service levels.

Established service levels support the computation of time described in 10 CFR 2.1017. This translates into a top-level criterion that the electronic hearing docket (EHD) should be available for at least 20 hours a day. The EHD provides on-line access to the contents of the Official Docket for NRC adjudications. It contains orders, filings, transcripts, exhibits and discovery material (Hearing Files collections) for individual adjudications.

The top-level criterion is met with the following 5 sub-system level technical requirements:

1. Electronic Information Exchange (EIE) available at all times (except for published maintenance period) for parties to submit and retrieve documents.

2. EIE submittal acknowledgement and service list notification functions are operable consistent with the times noted in paragraph 1, supra.

3. The Document Processing Center (DPC) processing time from receipt of document to staging in the appropriate ADAMS (NRC electronic records system) publication folder - less than 8 working hours during normal working hours.

4. Total turnaround time (EIE receipt to EHD availability) to be not more than 3 working days.

5. Help desk support will be available during normal business hours.

For FY 2004, the target was met because the development of information technology and information management systems and business processes was on schedule.

For FY 2005, the target was met because all information technology and information management issues were resolved on schedule and the Meta-System was made operational.

For FY 2006, the target was met because the requested level of service provided for operations of information technology components and information management services during the pre-licensing phase resulted in the electronic docket being available for all required access hours.

Note: This measure is treated as an annual measure in the NRC Performance Budget. As explained in Question 2.1, this measure also serves as a long-term measure demonstrating that the Program is making progress in preparing to review a potential DOE license application.

Measure: Ensure that NRC's high-level waste documentary material is made electronically available in compliance with Part 2, Subpart J, and Pre-License Application Presiding Officer and Commission orders.

Explanation:

Supports Program Openness Goal: Ensure openness in our regulatory process.

Supports Program Effectiveness Goal: Ensure NRC actions are effective, efficient, realistic, and timely.

Measures the Program's second main prelicensing activity: Preparing staff and infrastructure for a review and hearing process that can be completed 3-4 years after submission of the application or approximately 2012. The Licensing Support Network (LSN) is an electronic database established by the NRC that makes publicly available documents relevant to the licensing proceedings for the potential geologic repository at Yucca Mountain, Nevada. The Atomic Safety Licensing Board Panel (ASLBP) administers the LSN. Each participant in the proceedings must provide NRC access to its document collection and must certify that its document collection is complete shortly after DOE has certified its collection is complete. Since NRC will also be a participant in any licensing proceedings, the Program certified its document collection was available and complete in 2004, consistent with the FY 2004 target. The Program continued to supplement its document collection twice a quarter consistent with the FY 2005 target. On July 8, 2005, the Pre-License Application Presiding Officer (PAPO) Board ordered that document collections must be supplemented monthly after certification, which the Program met. In February 2006, the PAPO Board suspended the supplementation requirements since DOE has not yet satisfactorily certified its document collection. Since February 2006, the Program has set self-imposed requirements to supplement its document collection quarterly. The Program has met the quarterly supplementation requirements consistent with the FY 2006 and FY 2007 targets. This measure implements means and strategies in the agency's Strategic Plan: (2) making systematic improvements to the regulatory program.

New measure in FY 2004.

FY 2004 Target: If appropriate, certify the availability of NRC's high-level waste document collection to the Licensing Support Network (LSN) 1 month after DOE certifies its document collection.

FY 2005 Target: Ensure continued availability of the NRC high-level waste document collection to the LSN.

FY 2006 Target: Ensure supplementation of the NRC high-level waste document collection to the LSN in accordance with established requirements.

FY 2007 Target: Ensure supplementation of the NRC high-level waste document collection to the LSN in accordance with established requirements.

FY 2008 Target: Ensure supplementation of the NRC high-level waste document collection to the LSN in accordance with established requirements.

Note: This measure is treated as an annual measure in the NRC Performance Budget. As explained in Question 2.1, this measure also serves as a long-term measure demonstrating that the Program is making progress in preparing to review a potential DOE license application.

Measure: Independent technical advice on adjudicatory and non-adjudicatory matters; monitor implementation of the LSN.

Explanation:

Supports Program Openness Goal: Ensure openness in our regulatory process.

Supports Program Effectiveness Goal: Ensure NRC actions are effective, efficient, realistic, and timely.

Measures the Program's second main prelicensing activity: Preparing staff and infrastructure for the review and hearing process. During review of a license application, the Commission may need to act in the adjudicatory process. NRC rules on separation of function require that staff engaged in the application review be kept separate from the Commission during this period. Staff with the proper skills and expertise, but not assigned to the application review, have therefore been identified to serve as Commission Adjudicatory Technical Staff, to provide technical support to the Commission during the separation period. This group was identified and initiated during FY2005, when a license application appeared imminent. The staff list is being maintained during the delay in the application, and the group will be re-instituted when an application is received. By supporting an open and effective regulatory process, this activity provides for the safe and secure operation and performance of a repository, if and when it is ultimately licensed. This measure implements means and strategies in the agency's Strategic Plan: (2) making systematic improvements to the regulatory program.

New measure in FY 2004.

FY 2004 Target: Establish formal staffing plan and plan for providing Commission with. adjudicatory technical support. Begin monitoring prelicensing activities and Licensing Support Network (LSN) implementation.

FY 2005 Target: Complete establishment of Commission Adjudicatory Technical Support. program, initiate review of staff licensing documents and provide technical advice to the Commission on the licensing proceeding and the implementation of the LSN.

FY 2006 Target: Maintain existing infrastructure.

FY 2007 Target: Maintain existing infrastructure.

FY 2008 Target: Maintain existing infrastructure.

Note: This measure is treated as an annual measure in the NRC Performance Budget.

Measure: Resolve key technical issues developed during pre-licensing.

Explanation:

Supports Program Safety Goal: Ensure protection of public health and safety and the environment.

Supports Program Security Goal: Ensure the secure use and management of radioactive materials.

Measures the Program's third main prelicensing activity: Identifying significant technical issues important to safety and security. Prelicensing interactions between the Program and DOE, as allowed by law, focus on identifying information needed for a comprehensive, complete license application. In 2000-2001, information needs were formalized as a set of 293 Agreements on Key Technical Issues, and their integrated sub issues. These cover concerns on specific features, events, and processes that may significantly affect the safe and secure operation and performance of a future geologic repository. The issues are discussed at public meetings, and agreements are closed by NRC letter as DOE provides the identified information in writing. The Program identifies additional emerging issues in formal letters to DOE, and works to resolve these concerns through public meetings and letters. The majority of the Agreements defined in 2000-2001 are now closed, but the issue identification and resolution process will continue until an application is submitted. The adequacy of information in the application will ultimately be determined during application review and the licensing hearings. The program has established a metric requiring that prelicensing issue resolution letters to DOE meet timeliness and quality goals. The quality of these letters is assured by using appropriate technical disciplines, by security review, by identification of major concerns through performance assessment oversight, and by management review. The issue resolution process directly supports the long-term agency goals of safety and security by anticipating and resolving safety and security issues so that the license application is of high quality and staff can perform a thorough and effective review. This measure implements means and strategies in the agency's Strategic Plan: (2) making systematic improvements to the regulatory program; (3) using sound science and risk-informed, performance-based regulations and (4) anticipating and resolving safety issues.

FY 2003 Target: Resolve of KTI integrated subissues / keep pace with DOE schedule.

FY 2004 Target: Resolution of KTI agreements concerns meets staff timeliness and quality goals.

FY 2005 Target: Resolution of KTI agreements concerns meets staff timeliness and quality goals.

FY 2006 Target: Resolution of KTI and pre-closure concerns meets staff timeliness and quality goals.

FY 2007 Target: Resolution of KTI and pre-closure concerns meets staff timeliness and quality goals.

FY 2008 Target: Resolution of KTI and pre-closure concerns meets staff timeliness and quality goals.

This output measure sunsets with receipt of a license application.

Note: This measure is treated as an annual measure in the NRC Performance Budget. As explained in Question 2.1, this measure also serves as a long-term measure demonstrating that the Program is making progress in preparing to review a potential DOE license application.

Measure: Conduct observation audits of DOE quality assurance as needed in accordance with DOE's schedule.

Explanation:

Supports Program Safety Goal: Ensure protection of public health and safety and the environment.

Measures the Program's third main prelicensing activity: Identifying significant technical issues important to safety and security. The prelicensing framework allows the Program to observe (but not lead) quality assurance audits of DOE and its contractors. Nuclear safety culture places a high premium on quality assurance during all aspects of a project, including development of data and analyses in support of a license application. To support development of a robust quality assurance process, the Program identifies key audits for observation, and documents the observation findings in written Audit Observation Reports that are transmitted to DOE in a timely manner. Issues identified through audit observations are further discussed and resolved through public meetings and letters as warranted by their significance for information used by DOE to predict future repository performance. This measure tracks identification of audits to be observed and completion of the audit observation process. The audit observation process directly supports the agency long-term safety goal by providing a transparent and traceable link from supporting information through the licensing process. This measure implements means and strategies in the agency's Strategic Plan: (2) making systematic improvements to the regulatory program; and (4) anticipating and resolving safety issues.

FY 2003 Target: On Schedule.

FY 2004 Target: Identified Audits on schedule or have been rescheduled.

FY 2005 Target: Identified Audits on schedule or have been rescheduled.

FY 2006 Target: Identified Audits on schedule or have been rescheduled.

FY 2007 Target: Identified Audits on schedule or have been rescheduled.

FY 2008 Target: Identified Audits on schedule or have been rescheduled.

Note: This measure is treated as an annual measure in the High-Level Waste Repository Safety Division Operating Plan. As explained in Question 2.1, this measure also serves as a long-term measure demonstrating that the Program is making progress in preparing to review a potential DOE license application.

Measure: High-Level Waste Repository Resolution of key technical issues and pre-closure concerns.

Explanation:

Supports Effectiveness Goal: Ensure that NRC actions are effective, efficient, realistic, and timely.

Efficiency measure for the Program's third main prelicensing activity: Identifying significant technical issues important to safety and security. The Program uses public letters to DOE to resolve technical issues important to security and safety that are identified during prelicensing, and has established a metric requiring that these issue resolution letters meet timeliness and quality goals. This measure has been implemented for many years. The quality of these letters is assured by using appropriate technical disciplines, by security review, by identification of major concerns through performance assessment oversight, and by management review. In the past, this metric required greater than or equal to 90% of the letters achieve their quality goal and greater than or equal to 80% of the letters achieve their timeliness goal. Based on past experience, the current metric has been tightened, so that no more than one letter each quarter misses its timeliness goal and no letters miss their quality goal. In FY2008, while still meeting timeliness and quality goals, the program plans to reduce the cost of producing these letters by 5% from a baseline established in the previous fiscal year. Efficiencies gained by this activity will be applied to the writing of formal "Requests for Additional Information" during the license application review. This measure implements means and strategies in the agency's Strategic Plan: (2) making systematic improvements to the regulatory program; (3) using sound science and risk-informed, performance-based regulations and (4) anticipating and resolving safety issues.

New Measure in FY 2008 (Baselining in FY 2007)

FY 2008 Target: Reduce the NRC staff cost for letters to DOE documenting how NRC is addressing key issues by 5% from the previous fiscal year, while still meeting the timeliness and quality targets.

Baseline data will be collected in FY 2007 (this is an efficiency metric for the output measure entitled "Resolve key technical issues developed during prelicensing").

Measure: Reductions in combined NRC and contractor staffing requirements to complete Major Tasks in the High-Level Waste Licensing Review Program Project Plan compared to level projected in the plan.

Explanation:Measurement methodology is still under development. Expected annual targets to be less than 5%. Wording changes may be needed as well. Note that other measures for this plan will be discontinued upon completion and approval of this new measure.

Is the program purpose clear?

Explanation:

The High-Level Waste Repository Program (henceforth the Program) has a clear purpose, which is to ensure that high-level waste (including both spent-nuclear fuel and high-level radioactive waste) that the U.S. Department of Energy (DOE) transports to, and disposes of, in a geologic repository, is disposed of in a manner that protects public health, safety, security, and the environment. DOE has been studying Yucca Mountain, Nevada for many years, as a potential repository site. Because the proposed repository is a first-of-a-kind, the Program's purpose now is to establish a system of regulation that will deliver the safety, security and environmental objectives, in the future, and over the long term, if and when the repository is licensed, constructed and operated [1-6].

The purpose of the Program, to create a regulatory system to ensure public health, safety, security, and environment, if and when the repository is constructed and operated by DOE, is embodied in the two strategic goals of the Program, namely safety and security, and the supporting process-oriented goals, namely openness and effectiveness [7]. Safety and security are strategic goals of the Program, given the hazardous nature of high-level waste. Openness is a key process-oriented goal since disposal of high-level waste has high stakeholder interest and is potentially highly contentious. Effectiveness is also a key process-oriented goal, since the Commission decision on whether to authorize construction of a geologic repository is a key milestone in implementing the Nation's nuclear waste policy, and Congress has set a statutory time frame of 3 to 4 years for this decision [3].

The Program funds the licensing and inspection activities associated with canisters and casks to be used for the transportation of high-level waste to a geologic repository. These activities will be performed by the Spent Fuel Storage and Transportation Program, using the same performance measures, regulations, and processes evaluated in the (fiscal year) FY 2005 PART of the Spent Fuel Storage and Transportation Program [8]. Therefore, these activities will not be discussed in this PART evaluation.

Evidence:

Four pieces of legislation give the Program its regulatory authority:

[1] Atomic Energy Act of 1954, as Amended ; Chapters 6,7,and 8, pages 1-24 to 1-42, (Note: The Atomic Energy Act of 1954 provides general regulatory authority to the NRC but is not high-level waste specific);

[2] Energy Reorganization Act of 1974 ; Sections 202, 204: pages 2-18 to 2-20;

[3] Nuclear Waste Policy Act of 1982, as amended ; Sections 8, 111: pages 4-8 to 4-10 (75-77 of 192);

[4] Energy Policy Act of 1992 ; Section 801: pages 4-85 to 4-86 (152-153 of 192);

The NRC strategic plan defines the goals of the NRC, which are also the goals of the Program:

[5] NRC Strategic Plan FY2004-FY2009; page 7, see Strategic Objective;

Two NRC publications provide a broad description of the Program:

[6] 2006-2007 NRC Information Digest (NUREG 1350, Volume 18), pages 66-67;

[7] NRC Regulator of Nuclear Safety (NUREG/BR-0164, Rev. 4), pages 17-19;

The following PART was performed in 2005 and is cited:

[8] Spent Fuel Storage and Transportation Licensing and Inspection PART Program Assessment.

Does the program address a specific and existing problem, interest, or need?

Explanation:

The Program addresses the specific public need to have an independent regulator of DOE to ensure that the disposal of high-level waste will be safe and secure and protects the environment. High-level waste is a long-term safety concern, since some elements within the high-level waste remain radioactive for long periods of time and thus must be isolated from society. To address this safety concern, it has been National policy for over 30 years for NRC to independently regulate the DOE disposal of high-level waste [1-4]. Given that actual disposal of high-level waste has not yet begun and once begun (which DOE estimates to be approximately 2017) will continue for at least several decades, the need for the Program still exists and the purpose of the Program is still relevant to current conditions.

The specific need the Program is now addressing is establishing a regulatory system for the licensing and regulation of the repository. Because no repository for high-level waste has ever been licensed or regulated in the U.S. (or elsewhere), a regulatory process first needs to be created, and the Program addresses this need and will continue to do so in phases. In particular, although the long-term need for the Program remains constant, to ensure safety, security, and protection of the environment, the specific needs the Program addresses over time evolves as DOE's geological repository program evolves. This evolution of the Program can be described as passing through a series of phases, including pre-licensing, licensing, construction, operation, and permanent closure. With current DOE plans to submit a license application by June 2008, the pre-licensing responsibilities of the Program may be nearing an end. The Program is now actively preparing for its licensing responsibilities. Accordingly, the Program is transitioning from addressing pre-licensing needs such as: (1) pre-licensing consultations; (2) regulation and guidance development; (3) preparing for an effective hearing process; and (4) license review preparation; to addressing licensing needs such as: (1) completing a safety evaluation report; (2) making a decision to adopt DOE's environmental impact statement; and (3) conducting adjudicatory hearing proceedings [5-7].

Evidence:

Four pieces of legislation give the Program its regulatory authority:

[1] Atomic Energy Act of 1954, as Amended ; Chapters 6,7,and 8, pages 1-24 to 1-42, (Note: The Atomic Energy Act of 1954 provides general regulatory authority to the NRC but is not high-level waste specific);

[2] Energy Reorganization Act of 1974 ; Sections 202, 204: pages 2-18 to 2-20;

[3] Nuclear Waste Policy Act of 1982, as amended ; Sections 8, 111: pages 4-8 to 4-10 (75-77 of 192);

[4] Energy Policy Act of 1992 ; Section 801: pages 4-85 to 4-86 (152-153 of 192);

The NRC strategic plan defines the goals of the NRC, which are also the goals of the Program:

[5] NRC Strategic Plan FY2004-FY2009; page 7, see Strategic Objective;

Two NRC publications provide a broad description of the Program:

[6] 2006-2007 NRC Information Digest (NUREG 1350, Volume 18), pages 66-67;

[7] NRC Regulator of Nuclear Safety (NUREG/BR-0164, Rev. 4), pages 17-19.

Is the program designed so that it is not redundant or duplicative of any other Federal, state, local or private effort?

Explanation:

The Program is designed so that it is not redundant or duplicative of any other Federal, State, local, or private effort. The Program is the exclusive and independent regulator for the disposal of high-level waste. The regulatory functions assigned to the Program by the Energy Reorganization Act of 1974, the Nuclear Waste Policy Act of 1982, as amended; and the Energy Policy Act of 1992, do not overlap with other Federal nor non-Federal efforts but, rather, complement functions assigned to other Federal programs [1-4]. These Acts made the high-level waste regulatory function solely Federal, pre-empting any State or local regulatory functions. DOE is responsible for siting, obtaining a license, constructing, operating, closing, and decommissioning a geologic repository for the disposal of high-level waste. DOE is also responsible for transporting high-level waste to the geologic repository. The U.S. Environmental Protection Agency (EPA) is responsible for the setting of public health and environmental radiation protection standards for Yucca Mountain. The Program is responsible for establishing a regulatory framework and for licensing and providing oversight of the geologic repository being developed by DOE. The Acts require that NRC regulations for a repository at Yucca Mountain be consistent with, and implement the standards set by, EPA, and NRC must, to the extent practicable, adopt the Final Environmental Impact Statement prepared by DOE. The Program is also responsible for licensing and inspecting the transportation packages DOE will use to transport high-level waste to a geologic repository. The Department of Transportation regulates the transportation of high-level waste in NRC-licensed transportation packages to the repository [5-6].

Evidence:

Four pieces of legislation give the Program its regulatory authority:

[1] Atomic Energy Act of 1954, as Amended ; Chapters 6,7,and 8, pages 1-24 to 1-42, (Note: The Atomic Energy Act of 1954 provides general regulatory authority to the NRC but is not high-level waste specific);

[2] Energy Reorganization Act of 1974 ; Sections 202, 204: pages 2-18 to 2-20;

[3] Nuclear Waste Policy Act of 1982, as amended ; Sections 8, 111, pages 4-8 to 4-10 (75-77 of 192);

[4] Energy Policy Act of 1992 ; Section 801, pages 4-85 to 4-86 (152-153 of 192);

The following diagram and description illustrate the complementary functions of Federal agencies involved in the disposal of high-level waste:

[5] Diagram of Federal Roles for the Disposal of High-Level Waste ;

[6] Description of Federal Roles for the Disposal of High-Level Waste .

Is the program design free of major flaws that would limit the program's effectiveness or efficiency?

Explanation:

The Program design is free of major flaws that would limit its effectiveness or efficiency in meeting its objectives or strategic goals. The Program has the sole and independent responsibility for regulating the disposal of spent nuclear fuel and high-level waste. It has been national policy for over 30 years, since NRC's creation, that the disposal of high-level waste should be independently regulated, to ensure safety, security, and protection of the environment [1-4]. The underlying statutes are explicitly aimed at protecting public health, safety, and the environment, and there is no convincing evidence that eliminating an independent regulator will be more efficient and effective, while achieving the same Program goals of ensuring safety, security, and protection of the environment.

The Program has developed two unique attributes, to increase its effectiveness, which would be challenging to readily duplicate: (1) risk-informed, performance-based regulations; and (2) a Federally Funded Research and Development Center (FFRDC). The Program's risk-informed, performance-based regulations permit DOE to use the most efficient approaches to ensure safety and security, consistent with the current state of knowledge [5]. This is because, with risk-informed, performance-based regulations, the safety criteria are focused on potential health effects (i.e., doses, to individuals), as opposed to mitigating pre-selected scenarios, some of which may be of limited risk-significance at Yucca Mountain. Also, the regulations allow DOE to demonstrate the integrated performance of the repository, rather than meeting performance criteria for individual engineered and natural components of the repository, potentially allowing DOE to develop a more overall effective repository. The National Academy of Sciences strongly recommended a risk-informed, performance-based approach [6].

The Program's FFRDC, the Center for Nuclear Waste Regulatory Analyses (CNWRA) at the Southwest Research Institute, provides technical assistance and independent analysis, free of conflict of interest, with long-term continuity, in support of the Program. Freedom from conflict of interest is important, since many of the contractors supporting NRC for non-high-level waste activities, such as DOE national laboratories, are supporting the DOE repository program, and thus would have a potential conflict of interest. Long-term continuity is important, since the Program's responsibilities may extend many decades and the Program's resources for technical support activities are limited compared to DOE's, constricting the Program's ability to compete for contractors [7].

It would be incorrect to argue Congress' 3-to-4-year decision schedule will cause decisions to be made too quickly, and is therefore a flaw. The schedule is not unconditionally required, and such provisions are commonplace and do not cause undue haste. The Program has made process improvements, such as managing documents electronically, and remains subject to public checks and balances.

The lack of a requirement for a final EPA standard, before any license application can be filed, is similarly not a flaw. While DOE ultimately decides when (and whether) to submit the application, the Program can reject a premature application.

Further, no flaw is presented by the lack of a requirement for the Program to consider the work of the Nuclear Waste Technical Review Board (NWTRB), an independent, expert technical review panel reporting to the Congress and the Secretary of Energy. The Program must (and will) consider any significant, unresolved safety issue when it reviews the application, including any unresolved NWTRB safety concern. The Program recognizes the importance of the NWTRB, and is monitoring its work (and, more broadly, all technical work of potential relevance to the Program) to better understand its views.

Evidence:

Four pieces of legislation give the Program its regulatory authority:

[1] Atomic Energy Act of 1954, as Amended ; Chapters 6,7,and 8, pages 1-24 to 1-42, (Note: The Atomic Energy Act of 1954 provides general regulatory authority to the NRC but is not high-level waste specific);

[2] Energy Reorganization Act of 1974 ; Sections 202, 204: pages 2-18 to 2-20;

[3] Nuclear Waste Policy Act of 1982, as amended ; Sections 8, 111: pages 4-8 to 4-10 (75-77 of 192);

[4] Energy Policy Act of 1992 ; Section 801: pages 4-85 to 4-86 (152-153 of 192);

A discussion of the Program's risk-informed, performance-based regulations was provided in their initial promulgation:

[5] Federal Register Publication of Final 10 CFR Part 63 - Disposal of High-level Radioactive Wastes in a Geologic Repository at Yucca Mountain, Nevada and Supplementary Information ; November 2, 2001, (66 FR55732) pages 1-5;

The National Academy of Sciences recommendation to use risk-informed, performance-based regulations:

[6] Technical Bases for Yucca Mountain Standards, Executive Summary ; National Academy Press, Washington, DC 1995, page 7;

Key attributes of the Program's contractor are specified in the contract:

[7] Contract 02-02-012, "For the Operation of the Center for Nuclear Waste Regulatory Analyses as a Federally Funded Research and Development Center"; (Official Use Only).

Is the program design effectively targeted so that resources will address the program's purpose directly and will reach intended beneficiaries?

Explanation:

The Program's design effectively targets resources at the Program's purpose of establishing a regulatory process to ensure the safety, security, and environmental protection for those individuals who may be impacted by the geologic disposal of high-level waste (i.e., the intended beneficiaries) [1-4]. The intended goals, outcomes, or benefits of the Program; safety, security, openness, and effectiveness; are each intended to reach somewhat different beneficiaries [5]. The Program's safety and security goals are directed primarily toward those most likely to be impacted by the geologic repository, those people now, or in the future, living near the potential geologic repository, or those who may come in contact with water passing through the potential geologic repository. These safety and security beneficiaries are effectively targeted, since the Program's resources are directed at ensuring that DOE complies with the Program's health-based standards, should DOE become a licensee. The Program's openness goals are directed toward interested stakeholders, including many from the vicinity of Yucca Mountain. These openness beneficiaries are effectively targeted, since the Program's resources also support the significant public access to information and participation, through the Program's public document collections, public outreach activities, public meetings with DOE, and adjudicatory proceedings. The Program's effectiveness goals benefit nuclear utility ratepayers, taxpayers, and the general public, by positioning the Program to meet a major milestone in implementing the Nation's nuclear waste policy, deciding on whether to authorize construction of a geologic repository [6-7].

Activities that would have occurred without the Program are not being subsidized. The Program's independent regulatory functions cannot occur without Federal funding, and the Program's regulatory activities are separately funded by the Nuclear Waste Fund (made up of contributions by nuclear waste generators), whereas other activities at NRC are funded by fees imposed on licensees or applicants, or by general appropriations. Using only Nuclear Waste Fund fees for Program activities facilitates both: (1) ensuring that Program resources are not subsidizing other NRC activities; and (2) directing Program resources to the intended beneficiaries.

Evidence:

Four pieces of legislation give the Program its regulatory authority:

[1] Atomic Energy Act of 1954, as Amended ; Chapters 6,7,and 8, pages 1-24 to 1-42, (Note: The Atomic Energy Act of 1954 provides general regulatory authority to the NRC but is not high-level waste specific);

[2] Energy Reorganization Act of 1974 ; Sections 202, 204: pages 2-18 to 2-20;

[3] Nuclear Waste Policy Act of 1982, as amended ; Sections 8, 111: pages 4-8 to 4-10 (75-77 of 192);

[4] Energy Policy Act of 1992 ; Section 801: pages 4-85 to 4-86 (152-153 of 192);

The NRC strategic plan defines the goals of the NRC, which are also the goals of the Program:

[5] NRC Strategic Plan FY2004-FY2009; page 7, see Strategic Objective;

The Program's budget describe how Program resources are being spent:

[6] NRC FY2007 Performance Budget (NUREG-1100, Vol. 22) ; High-Level Waste Repository, pages 63-71;

[7] NRC FY2008 Performance Budget (NUREG-1100, Vol. 23) ; High-Level Waste Repository, pages 62-69.

Does the program have a limited number of specific long-term performance measures that focus on outcomes and meaningfully reflect the purpose of the program?

Explanation:

The Program has a limited number of specific long-term performance measures that focus on outcomes and meaningfully reflect the purpose of the Program. The Program shares the agency-wide long-term performance measures to prevent significant consequences from radiation exposures and releases. Until the repository begins receiving high-level waste, the agency-wide performance measures are not applicable at this time. Rather, and reflecting that the Program's goal now is creating a system for regulating the repository, the Program's output-based annual measures reflect the long-term means and strategies in the agency's Strategic Plan, including (1) establishing a licensing and regulatory program; (2) making systematic improvements to the regulatory program; (3) using sound science and risk-informed, performance-based regulations; and (4) anticipating and resolving safety issues [1]. The Program considers its annual measures to function as both long-term and annual measures, since they mirror long-term strategies for regulating an operating repository by 2017, and demonstrate progress towards an intermediate goal in the Strategic Plan, being prepared to review a license application (expected in 2008) while ensuring safety and security. This treatment of the Program measures has been in place for many years and is reasonable since they will position the Program to meet the agency-wide long-term measures.

The Program performance measures demonstrate progress in three main pre-license application activities that directly contribute to the ultimate safety and security of a potential repository: (1) establishing a complete and rigorous regulatory framework; (2) preparing staff and infrastructure for the review and hearing process; and (3) identifying significant technical issues important to safety and security [2-6].

Regulations and guidance ensure safety and security by defining criteria that NRC believes will ensure protection of public health, safety and security. Thus, if the Program determines that the repository design and activities comply with the regulations, there will be a reasonable basis to believe it will achieve safety and security performance measures. The program has measures to track the preparation and revisions of the high-level waste regulations and guidance.

Preparing staff and infrastructure for the review and hearing process is an important activity that will help the program achieve its long-term performance measures by making adequate security and safety decisions. To make good decisions, the program will need to conduct a thorough, effective, and fair review and hearing by a qualified staff. Three measures are relevant for this area. To conduct a license application review, staff will need to be trained on regulations and guidance as well as developing independent technical expertise. A performance measure is used to evaluate staff training through a formal qualification process for High-Level Waste Safety Technical Reviewers. Preparation for review and hearings includes creation and maintenance of an electronic system for managing hearing documents and information during the complex hearing proceedings. Two performance measures track these activities.

Identifying significant technical issues important to safety and security is an important activity that will enable the program achieve its long term goals by focusing NRC staff, Department of Energy staff, and other interested parties on those technical issues of a repository that are important to safety and security. Providing technical input to DOE helps the national program to evaluate and address important security and safety concerns. Quality assurance observation audits help to insure that safety and security decisions will be supported by data that are both transparent and traceable. One performance measure tracks issue resolution activities and another tracks NRC observation of DOE quality assurance audits.

Evidence:

The NRC Strategic Plan describes the means and strategies the Program is using to meet its goals:

[1] NRC Strategic Plan FY2004-FY2009; page 10-11, Safety Strategies;

The Program's annual measures, which also serve as long-term measures, are in the Program's budget documents:

[2] NRC FY2007 Performance Budget (NUREG-1100, Vol. 22) ; Program Outputs, pages 63-71;

[3] NRC FY2008 Performance Budget (NUREG-1100, Vol. 23) ; Program Outputs, pages 62-69;

Two of the Program's measures are taken from a division level operating plan:

[4] Division of High-Level Waste Repository Safety Operating Plans for FY 2003 - FY 2007 (Official use Only);

These reports describes annual Program results:

[5] NRC FY2006 Performance and Accountability Report, Chapter 1 ; pages 7-11, see Strategic Outcomes;

[6] NRC Performance and Accountability Reports, FY2000-FY2006 ; Targets are described in Chapter 1.

Does the program have ambitious targets and timeframes for its long-term measures?

Explanation:

The Program has ambitious targets and timeframes for its long-term measures. These targets and timeframes refer to measures in place for current prelicensing activities, as outlined in the response to 2.1, to achieve the Program's focus of creating the regulatory system needed for review and regulation of the potential high-level waste repository, expected to begin operation by 2017 [1-6].

The target for establishing the regulatory framework is ambitious in that necessary regulations and guidance need to be established well in advance of licensing actions, so that their requirements can be fully integrated into the application. This is ambitious in light of challenges imposed by external actions, such as the 2004 D.C. Circuit Court ruling that vacated portions of the EPA standard for a repository at Yucca Mountain and NRC's adoption of the standard in its rules, which will require rapid rulemaking following issuance of EPA's final standard.

Targets for staff preparation and infrastructure activities are also ambitious. Qualification of staff as Technical Reviewers has an ambitious target for qualifying new staff, especially given the number of new staff entering the Program due to retirements and additional staffing in anticipation of an application. Infrastructure activities were most intense during 2004 and 2005 when information management systems for hearings were being developed and made operational. Current targets for the meta-system and updating of the NRC document collection ensure that the systems are maintained and fully available once license review begins. Once an application is docketed, the targets are ambitious since they require full functionality of systems and processes for unprecedented electronic hearing support of a highly complex, first of a kind proceeding.

Targets for technical understanding are ambitious within the framework of defined interactions with the Department of Energy. Identification and resolution of key technical issues are measured against quality and timeliness criteria so that specific information and insights that may affect repository performance is communicated effectively to the potential applicant. Targets for the NRC observation of Department of Energy Quality Assurance activities are ambitious as possible, given the limited regulatory authority the Program has during prelicensing.

Evidence:

The NRC Strategic Plan describes the means and strategies the Program is using to meet its goals:

[1] NRC Strategic Plan FY2004-FY2009; page 10-11, Safety Strategies;

The Program's annual measures, which also serve as long-term measures, are in the Program's budget documents:

[2] NRC FY2007 Performance Budget (NUREG-1100, Vol. 22) ; Program Outputs, pages 63-71;

[3] NRC FY2008 Performance Budget (NUREG-1100, Vol. 23) ; Program Outputs, pages 62-69;

Two of the Program's measures are taken from a division level operating plan:

[4] Division of High-Level Waste Repository Safety Operating Plans for FY 2003 - FY 2007 (Official use Only);

These reports describes annual Program results:

[5] NRC FY2006 Performance and Accountability Report, Chapter 1 ; pages 7-11, see Strategic Outcome;.

[6] NRC Performance and Accountability Reports, FY2000-FY2006 ; Targets are described in Chapter 1.

Does the program have a limited number of specific annual performance measures that can demonstrate progress toward achieving the program's long-term goals?

Explanation:

The Program's annual performance measures support and indicate progress toward addressing its long-term goals, and serve as indicators of effective program management. As discussed in the response to 2.1, output-focused measures are used in the Program to measure progress through each discrete phase, toward creating a regulatory system that will deliver long-term outcome measures when and if a repository is operational. The annual measures considered here and in the response to 2.4 provide further evidence of progress. The agency's Strategic Plan explicitly recognizes near-term regulatory steps needed to achieve long-term outcomes. The Program's annual output measures mirror the near-term steps defined in the Strategic Plan, and thus provide a reliable indication of progress toward the Program's long-term goals [1].

The Program's annual performance measures that demonstrate progress toward achieving the Program's long term goals follow the same logical grouping as the long-term measures discussed in the response to 2.1: (1) establishing the regulatory framework; (2) preparing for an efficient review and hearing process; and (3) interacting with the Department of Energy on technical aspects of a potential application [2-4].

For the regulatory framework, the Program has one performance measure for completing final Yucca Mountain regulations and guidance in a timely manner after the EPA finalizes its Yucca Mountain standards. Both EPA and NRC are revising their regulations in response to the 2004 D.C. Circuit Court ruling. The measure is quantifiable in that it sets objective time limits. The measure demonstrates progress, as the revised regulations supplement the licensing criteria the Program will use to judge the safety and security of the Yucca Mountain repository, and increase the likelihood that a license application will contain sufficient information for NRC's review.

For preparing for an efficient hearing process, the Program has three performance measures related to maintaining systems and processes supporting discovery, hearings, and appeals. The systems and processes were developed at substantial expense when DOE planned to submit a license application in 2004. Maintaining the systems preserves the investment and supports DOE's plans to submit a license application in 2008. The measures demonstrate progress since they facilitate that participation of stakeholders in current and future high-level waste proceedings.

For pre-licensing safety issue resolution, the program has one output measure and a related efficiency measure. The output measure encourages resolution of technical issues that are important to security and safety. Significant pre-licensing safety and security technical concerns are publicly transmitted to the DOE via letters. The program has established a metric requiring that resolution of key technical issues and pre-closure concerns meet timeliness and quality goals. This measure has been implemented for many years. The quality of these letters is assured by using appropriate technical disciplines, by security review, by the identification of major concerns through performance assessment oversight, and by management review. In the past, this metric required greater than or equal to 90% of the letters achieve their quality goal and greater than or equal to 80% of the letters achieve their timeliness goal. Based on past experience, the current metric has been tightened up, so that no more than 1 letter/Qtr misses its' timeliness goal and no letter/Qtr misses its' quality goal. In FY 2008, while still meeting timeliness and quality goals, the program plans to reduce the cost of producing these letters by 5% from a baseline established in the previous fiscal year. Efficiencies gained by this activity will be applied to the writing of "requests for additional information" during the license application review.

Evidence:

The NRC Strategic Plan describes the means and strategies the Program is using to meet its goals:

[1] NRC Strategic Plan FY2004-FY2009; page 10-11, Safety Strategies;

The Program's annual measures, which also serve as long-term measures, are in the Program's budget documents:

[2] NRC FY2007 Performance Budget (NUREG-1100, Vol. 22) ; Program Outputs, pages 63-71;

[3] NRC FY2008 Performance Budget (NUREG-1100, Vol. 23) ; Program Outputs, pages 62-69; The Program's efficiency measure is on page 94;

Two of the Program's measures are taken from a division level operating plan:

[4] Division of High-Level Waste Repository Safety Operating Plans for FY 2003 - FY 2007 (Official use Only).

Does the program have baselines and ambitious targets for its annual measures?

Explanation:

The Program has baselines and ambitious targets for its annual measures. The baselines and targets for the three groups of the Program's annual measures identified in the response to 2.3 are discussed here in more detail [1-3].

For the regulatory framework measure, specific targets have been set to complete final Yucca Mountain regulations six months after the EPA finalizes its Yucca Mountain standards and to update Program guidance six months thereafter. The Program has baseline data from prior rulemaking and guidance development. The targets are ambitious for a rulemaking, especially given that the Program may need to develop specifications for the final standards that differ from those in EPA's proposed rule. This unprecedented rulemaking is also ambitious because it embodies the requirements for assessing the performance of the repository for a million years relying on a risk-informed methodology.

For preparing for an efficient hearing process, the Program has three performance measures related to maintaining systems and processes supporting discovery, hearings, and appeals. For discovery purposes, the Program must supplement its certified document collection on a monthly basis once DOE establishes its document collection. The requirement is currently suspended since DOE has not yet satisfactorily established its document collection. For hearings, the Program has established requirements for full electronic support of licensing hearings. The Program is conducting limited scope hearings, mostly on availability of document collections, prior to DOE submitting a license application. For appeals, the Program has established and maintained a group of technical staff independent of the Program to advise the Commission during high-level waste proceedings. Baselines and qualitative targets have been established for each measure. The targets during pre-licensing ensure that the systems are maintained and available should DOE submit a license application. The targets will be ambitious when full hearings begin.

For pre-licensing safety issue resolution, the program has one output measure and a related efficiency measure. The output measure encourages resolution of technical issues that are important to security and safety. Significant pre-licensing safety and security technical concerns are publicly transmitted to the DOE via letters. The program has established a metric requiring that resolution of key technical issues and pre-closure concerns meet timeliness and quality goals. This measure has been implemented for many years. The quality of these letters is assured by using appropriate technical disciplines, by security review, by the identification of major concerns through performance assessment oversight, and by management review. In the past, this metric required greater than or equal to 90% of the letters achieve their quality goal and greater than or equal to 80% of the letters achieve their timeliness goal. Based on past experience, the current metric has been tightened up, so that no more than 1 letter/Qtr misses its timeliness goal and no letter/Qtr misses its quality goal. In FY 2008, while still meeting timeliness and quality goals, the program plans to reduce the cost of producing these letters by 5% from a baseline established in the previous fiscal year. Efficiencies gained by this activity will be applied to the writing of "requests for additional information" during the license application review.

Evidence:

The Program's annual measures, which also serve as long-term measures, are in the Program's budget documents:

[1] NRC FY2007 Performance Budget (NUREG-1100, Vol. 22) ; Program Outputs, pages 63-71;

[2] NRC FY2008 Performance Budget (NUREG-1100, Vol. 23) ; Program Outputs, pages 62-69; The Program's efficiency measure is on page 94;

Two of the Program's measures are taken from a division level operating plan:

[3] Division of High-Level Waste Repository Safety Operating Plans for FY 2003 - FY 2007 (Official use Only).

Do all partners (including grantees, sub-grantees, contractors, cost-sharing partners, and other government partners) commit to and work toward the annual and/or long-term goals of the program?

Explanation:

The Program has one partner who commits to, and works toward the annual and long-term goals of the Program [1-3]. The Program sole partner is the Program's major contractor, the Center for Nuclear Waste Regulatory Analyses (CNWRA), an Federally Funded Research and Development Center (FFRDC), at the Southwest Research Institute in San Antonio, Texas. CNWRA was founded, in 1987, specifically to provide NRC with independent technical assistance, free of conflict-of-interest, on issues related to high-level waste. The long-term performance goals of the Program are delineated in the scope of work of the contract document and also in the charter, which addresses the mission of the CNWRA and is an attachment to the contract [4].

The annual performance measures of the Program are reflected in NRC's annual guidance for preparing CNWRA's annual Operations Plan. The Program identifies key high-level activities for the upcoming year, consistent with the annual measures and the phase of the Program. In the current prelicensing phase, the guidance directs the CNWRA to support the Program's main activities: (1) pre-licensing consultations; (2) regulation and guidance development; (3) preparing for an effective hearing process; and (4) license review preparation. The Program also identifies a prioritized range of technical studies, including laboratory and field studies, to enhance and support the staff's ability to independently review a DOE license application [5]. The CNWRA develops an operating plan which describes how the CNWRA will complete the tasks assigned by the Program and sets milestones for completing tasks and technical studies. The CNWRA operating plan is reviewed and accepted by the Program, ensuring that the CNWRA commits to; and works toward, the Program's goals [6].

Every four weeks, CNWRA submits a Program Manager's Progress Report, as required by the CNWRA contract with NRC. This report provide the current status of each major area of CNWRA's plan of technical work, as well as management issues, major problems, and a summary of the financial status. Program and CNWRA managers meet regularly to make appropriate adjustments to CNWRA's plan of work. For example, if fewer DOE reports are received for review than expected, managers will increase the amount of CNWRA independent technical study [7].

Monthly, the Program and CNWRA discuss the status of CNWRA products, particularly those scheduled to be completed in the next 60 days, during a "Commitment Control Log Meeting." This provides a forecast of potential impacts on Program milestones [8].

The Program uses the three award fee criteria, in the contract, to evaluate the performance of the CNWRA: (1) Technical: The extent to which the contractor provides high-quality technical assistance and research in support of the Program, including, timeliness, quality, and independence and initiative. (2) Management and Staffing: The extent to which the contractor develops, equips, staffs, and operates a Center capable of meeting NRC's long-term and short-term needs, establishes appropriate priorities, and uses available resources efficiently and effectively. (3) Cost Control and Contract Administration: The extent to which the contractor conducts its work in a cost-effective manner and has controls necessary to ensure that technical work products are completed within established cost limitations. The extent that the CNWRA completes work assigned to meet the Program's annual and long-term goals, consistent with the award fee criteria, can have significant impact on the annual award fee provided to the CNWRA [9].

Evidence:

The long-term and annual goals of the Program are described in the NRC Strategic Plan and the Program budget documents:

[1] NRC Strategic Plan FY2004-FY2009; page 10-11, Safety Strategies;

[2] NRC FY2007 Performance Budget (NUREG-1100, Vol. 22) ; Program Outputs: pages 63-71; Program Outcomes: Chapter 5, Performance Measurement, pages 88-93, Appendix 4, pages 156-173;

[3] NRC FY2008 Performance Budget (NUREG-1100, Vol. 23) ; Program Outputs: pages 62-69; Chapter 5, Performance Measurement, pages 87-94, Appendix 4, pages 157-174;

The contractor's mission is described in the Program's contract:

[4] "For the Operation of the Center for Nuclear Waste Regulatory Analyses as a Federally Funded Research and Development Center"; (Official Use Only);

The annual performance measures of the Program are reflected in the NRC's annual guidance for preparing the contractor's operations plan:

[5] NRC Interim Guidance for the Development of Fiscal Year 2007 Center for Nuclear Waste Regulatory Analyses Operation Plans, August 24, 2006 (Official Use Only);

[6] Draft Fiscal Year 2007 CNWRA Operations Plans for the High-Level Waste Repository, October 13, 2006 (Official Use Only);

The Program uses a number of mechanisms to ensure the contractor is working towards Program goals, including the following two status reports and an annual performance evaluation:

[7] CNWRA Program Manager Periodic Report (produced every four weeks) (Official Use Only);

[8] CNWRA Commitment Control Log Meeting (monthly status of CNWRA commitments) (Official Use Only);

[9] NRC Annual Evaluation of CNWRA Performance (Official Use Only).

Are independent evaluations of sufficient scope and quality conducted on a regular basis or as needed to support program improvements and evaluate effectiveness and relevance to the problem, interest, or need?

Explanation:

The Program has been, and will continue to be, subject to independent evaluations, of sufficient scope and quality, conducted on a regular basis, or as needed, to support program improvements and evaluate effectiveness and relevance. The Office of Inspector General (OIG) conducted an audit covering the Program, in 2005, in accordance with generally accepted Government auditing standards, and including a review of relevant management controls. The audit concluded that the Program satisfies NRC's NWPA responsibilities, through promulgation and implementation of regulations for reviewing a DOE license application (10 CFR Part 63), and that the Program is carrying out its prelicensing functions. The audit report found that the program did not, however, have a "holistic" communications plan for internal and external stakeholders, especially given the complexity of the issues involved in the HLW program. In response to this finding and the audit recommendation, the Program developed an integrated communications plan that addressed the issues, and enhanced its public outreach team [1].

Prospectively, the Commission has directed the Program to contract with an outside independent organization to conduct evaluations of the Program, with funding available in 2008. This Commission direction is part of an Agency-wide initiative to have regularly scheduled independent program evaluations of sufficient scope and quality to effectively identify any implementation actions that have the potential to improve the Program's performance. The Program would tentatively have such an evaluation in 2009 [2-3].

The Program's principal partner, the Center for Nuclear Waste Regulatory Analyses (CNWRA), is similarly subject to independent evaluations of sufficient scope and quality, conducted on a regular basis, or as needed, to support program improvements and evaluate effectiveness and relevance. CNWRA is subject to several NRC oversight and evaluation processes. These processes include an NRC Annual Program Review, assessing all aspects of the scope of work, programmatic relevance, timeliness of execution, staffing, management, and other measures of CNWRA performance. CNWRA is also subject to NRC's annual award fee evaluation process, involving an NRC review group that evaluates the quality, quantity, timeliness, and independence of CNWRA work in support of the Program [4]. Further, NRC conducts a full evaluation of the CNWRA every five years. It includes an assessment of the efficiency and effectiveness of the CNWRA in meeting the Program's needs, including the ability to maintain its objectivity, independence, quick-response capability, and currency in its field(s) of expertise [5-6]. Concurrently, the OIG also evaluates how NRC exercises technical oversight and contract administration of the CNWRA [7]. The NRC and OIG five year evaluations of CNWRA are described in more detail below in the evidence.

CNWRA is also subject to several other evaluation processes by other non-NRC entities. These processes include an annual cost-incurred audit, by the Defense Contracting Audit Agency, as the designated financial audit agency for the contract, which assesses the appropriateness of overhead, fringe, materials-handling burden, and other indirect costs associated with the contract [8]. The CNWRA is also subject to periodic financial audits by its parent, the Southwest Research Institute (SwRI), as well as an annual SwRI executive management review, covering CNWRA's business, plans and other operational matters. Finally, SwRI's quality systems group conducts an annual performance-based and compliance-based audit of CNWRA's quality assurance program, typically with NRC observation [9-11].

Evidence:

The Office of the Inspector General conducted an audit of the Program in 2005:

[1] Audit of NRC's High-Level Waste Program (OIG-5-A-10) ; February 24, 2005;

The staff has developed and the Commission has approved a plan for obtaining independent evaluations consistent with PART guidance:

[2] SECY-06-0181 - Independent Evaluation of NRC Programs, August 14, 2006 (Official Use Only);

[3] Staff Requirements - SECY-06-0181 - Independent Evaluation of NRC Programs, October 12, 2006 (Official Use Only);

The Program conducts an annual evaluation of its contractor:

[4] NRC Annual Evaluation of CNWRA Performance (Official Use Only);

The Program conducts a full evaluation of the CNWRA every five years as part of renewing its contract with the CNWRA. The Commission approves the renewal. This review includes not only financial analysis, but an evaluation of the technical capability and effectiveness of the Center. It includes an assessment of the efficiency and effectiveness of the CNWRA in meeting the programs needs, including the ability to maintain its objectivity, independence, quick-response capability, and currency in its field(s) of expertise. It also includes an assessment of the adequacy of CNWRA management in ensuring a cost-effective operation. At the request of the Executive Director for Operations and as part of the 5 year contract renewal evaluation, the Office of the Inspector General (OIG) will and has conducted audits to determine if the Nuclear Regulatory Commission (NRC) has adhered to Federal Acquisition Regulations (FAR) in preparing the renewal justification. As part of this audit, the OIG has also examined how NRC exercises technical oversight and contract administration of the Center. This included interviewing contract managers, representing about 30 percent of the total staff assigned to technical areas. The last OIG audit concluded the renewal justification adequately addressed the FAR criteria and that the program provided effective technical oversight and administration of the agency's contract with the CNWRA.

[5] SECY-02-0083-Staff Review of the Use and Need for Continued Sponsorship of the Center for Nuclear Waste Regulatory Analyses, May 16, 2002 (Official Use Only);

[6] SRM-SECY-02-0083-Staff Review of the Use and Need for Continued Sponsorship of the Center for Nuclear Waste Regulatory Analyses, June 11, 2002 (Official Use Only);

[7] OIG Audit of NRC Oversight of CNWRA (OIG-2-A-11) ; May 28, 2002;

The Program's contractor is audited annually in the areas of financial performance and quality assurance:

[8] Defense Audit Contract Agency FY2006 Audit of CNWRA, August 4, 2006 (Official Use Only);

[9] Institute Quality Systems FY2006 CNWRA Quality Assurance Audit ; July 28, 2006;

[10] NRC Observation of FY2006 CNWRA Quality Assurance Audit - Summary ;

[11] NRC Observation of FY2006 CNWRA Quality Assurance Audit - Report .

Are Budget requests explicitly tied to accomplishment of the annual and long-term performance goals, and are the resource needs presented in a complete and transparent manner in the program's budget?

Explanation:

The program budget fails to define the relationship between 1) annual and long-term performance targets and 2) resources. In addition, the program budget and performance presentation fails to make clear the impact of funding decisions on expected performance and does not provide evidence that the requested performance/resource mix will enable the program to achieve its performance goals.

NRC's Strategic Plan describes its mission and establishes Commission direction by defining a vision, strategic objective, goals, strategic outcomes, and strategies. The performance budget integrates NRC's Planning, Budgeting, and Performance Management (PBPM) functions by aligning resources with NRC's goals, and establishing performance measures to enable periodic measurement and monitoring of program execution [1-2]. NRC's Performance Budget to Congress, beginning with FY 2007, explicitly and clearly ties NRC's budget request to its Strategic Plan goals and strategic outcomes, as well as to the performance measures and output measures contained in the budget document. The FY 2007 Performance Budget identifies what long-term strategic outcomes and performance measures are supported by the Program, as well as what performance measure(s) are supported by each output measure under the activity. Although it is difficult to achieve a close correlation between outcomes and resources in regulatory programs, the components of NRC's PBPM process are closely linked and complementary, reflecting a continuous cycle of performance management centered on outcomes [3].

Annually, the Commission provides guidance on NRC's outcome-based performance measures, which indicate the level of success needed to achieve NRC's goals. In addition, NRC identifies which activities, under NRC's two major program areas, support NRC's outcome-based performance measures, and uses these as guides to formulate the budget.

Adequate protection of public health and safety and the environment has always been, and continues to be, NRC's primary goal. Accordingly, safety is the most important consideration in evaluating license applications, licensee performance, and proposed changes to the regulatory framework. Because security is essential to NRC's mission and linked with safety, it is also an important consideration in NRC's actions. NRC continuously works to improve its openness, effectiveness, and efficiency, and management excellence, consistent with its safety and security mission. NRC's resources are allocated to its Nuclear Reactor Safety Program and Nuclear Materials and Waste Safety Program areas, in alignment with NRC's goals of safety and security.

NRC performs an environmental scan and develops key planning assumptions that identify major program drivers that would significantly influence NRC's work activities and resource requirements. For each major activity, NRC identifies the major program outputs and output-based measures needed to achieve the outcome-based performance measures, taking into consideration the key planning assumptions. NRC also identifies and prioritizes planned activities needed to achieve the outputs in each major activity, and prioritizes them based on their contribution to goals. Lastly, NRC determines the resource requirements to achieve each planned activity, forming the basis for developing NRC's budgetary requests for each program area.

The FY 2007 Performance Budget identifies NRC's infrastructure and support costs and distributes them to programs as a portion of the total program cost. The allocation methodology is consistent with the methodology used for preparing NRC's financial statements.

Evidence:

NRC's performance budgets for FY 2007 and FY 2008:

[1] NRC FY2007 Performance Budget (NUREG-1100, Vol. 22) ; Chapter 5, Performance Measurement, pages 84-87;

[2] NRC FY2008 Performance Budget (NUREG-1100, Vol. 23) ; Chapter 5, Performance Measurement, pages 83-86;

[3] NRC's Planning, Budgeting, and Performance Management (PBPM) process:

(1) NRC Chief Financial Officer Memorandum, "FY 2007 Budget - Instructions for Information Required for the PBPM Review," February 5, 2005 (includes instructions for Common Prioritization, Key Planning Assumptions, Major Program Outputs, and Performance Measures) (Official Use Only);

(2) Staff Requirements Memorandum - COMSECY-05-005, "Key Planning Assumptions, Major Program Outputs and Performance Measures for the FY 2006 - FY 2007 Budget, "June 30, 2005 (Official Use Only);

(3) NRC Chief Financial Officer/Executive Director for Operations Memorandum, "Program Priorities for the FY 2008 Budget," February 15, 2006 (Official Use Only);

(4) FY2006-FY2007 Key Planning Assumptions for the Nuclear Materials and Waste Safety Program (Official Use Only);

(5) Program Office Common Prioritization Methodology, January 2005 (Official Use Only);

(6) Major Program Outputs (Official Use Only).

Has the program taken meaningful steps to correct its strategic planning deficiencies?

Explanation:

The Program has taken meaningful steps to correct strategic planning deficiencies. The Program has identified and corrected several strategic planning deficiencies in the last several years. The deficiencies were identified by the Program, the NRC Office of the Inspector General (OIG), and by the Office of Management and Budget (OMB). They are: (1) lack of organizational focus on high-level waste activities; (2) lack of an independent pool of experts free of conflict of interests, to advise the Commission; (3) lack of an integrated planning capability, to ensure adequate resources for the necessary infrastructure; (4) lack of an integrated plan, for licensing activities; (5) need to coordinate information technology/information management system activities across the Program; (6) need for better integration of high-level waste communication efforts; and (7) need for better linkage between the Program's budget request, the strategic plan, and the Program's performance measures.

(1) NRC created an organizational unit dedicated to regulating high-level waste disposal. The Division of High-Level Waste Repository Safety (HLWRS), within the Office of Nuclear Material Safety and Safeguards (NMSS), consolidates technical and project management staff working on high-level waste activities, including pre-licensing consultations with DOE, and preparing for the review of a license application [1].

(2) NRC has formed a group of qualified, independent technical staff available to advise the Commission in deciding appeals resulting from the Program's licensing proceedings. This group primarily draws on existing NRC staff, with the highly specialized skills to address high-level waste issues, but maintains their independence by restricting their involvement in Program activities [2].

(3) The Program has created a standing working group to coordinate and integrate high-level waste planning activities such as budgeting and preparing for the receipt of a license application. This working group includes Program representatives from: (1) the Commission; (2) the lead technical unit (HLWRS); (3) the Office of the General Counsel; (4) the Atomic Safety and Licensing Board Panel; (5) information services; (6) research; (7) security; (8) administration; (9) enforcement; (10) investigations; and (11) regional staff; and representatives from the Spent Fuel and Transportation Storage Program [3].

(4) The Program developed a licensing project plan. The plan outlines how the Program will conduct and manage the review of the DOE license application, including participation in hearings. The plan includes a combination of documented work processes, electronic tools, and the implementation of project management practices. The plan was originally developed for a FY 2005 license application submittal and is being updated for a possible late FY 2008 submittal. The plan has been used for estimating resources needed during a license application review [4].

(5) The Program has established an information technology/information management Systems Senior Management Team, which meets regularly to coordinate these issues across the Program [5].

(6) The Program has responded to recommendations in a FY 2005 NRC OIG audit, to better integrate the high-level waste communication efforts across NRC, and to enhance its public outreach team for high-level waste activities [6].

(7) NRC's Performance Budget identifies NRC's infrastructure and support costs, and distributes them to programs as a portion of the total program cost. The allocation methodology is consistent with the methodology used for preparing NRC's financial statements. Beginning in FY 2007, NRC's Performance Budget to Congress explicitly and clearly ties NRC's budget request to its Strategic Plan goals and strategic outcomes, as well as to the performance measures and output measures contained in the budget document [7-9].

Evidence:

The following evidence provides references for the identified strategic planning deficiencies and their associated resolution as described in the explanation:

[1] Office of Nuclear Materials Safeguards Functions ; See Division of High-Level Waste Repository Safety;

[2] Staff Requirements - SECY-03-0120 - Response to SRM Dated June 11, 2002: Recommendations and Progress in Identifying Commission Adjudicatory Employees for the Adjudication of a License Application for a Yucca Mountain High Level Waste Repository, November 25, 2003 (Official Use Only);

[3] Appointment of John J. Linehan to Director, High Level Waste Business and Program Integration Staff, Office of Nuclear Material Safety and Safeguards, employee announcement, March 13, 2003;

[4] High-Level Waste Program Licensing Review Project Plan, December 2005 (Official Use Only);

[5] High-Level Waste, Licensing Support Program, Project Plan, June 9, 2004 (Official Use Only);

[6] Audit of NRC's High-Level Waste Program (OIG-5-A-10) ; February 24, 2005;

[7] NRC FY2007 Performance Budget (NUREG-1100, Vol. 22) ; Strategic Outcomes and Performance Measures, pages 64; Chapter 5, Performance Assessment, 88-93; Appendix 4, pages 156-173;

[8] NRC FY2008 Performance Budget (NUREG-1100, Vol. 23) ; Strategic Outcomes and Performance Measures, pages 63; Chapter 5, Performance Assessment, 87-94; Appendix 4, pages 157-174;

[9] NRC Strategic Plan FY2004-FY2009 ; page 7, see Strategic Outcomes.

Are all regulations issued by the program/agency necessary to meet the stated goals of the program, and do all regulations clearly indicate how the rules contribute to achievement of the goals?

Explanation:

All the regulations issued by the Program are necessary to meet the stated goals of the Program and to meet statutory requirements. The Nuclear Waste Policy Act of 1982 [1] required the Program to promulgate technical requirements and criteria that the Program will apply in approving or disapproving applications for: (1) authorizing construction; (2) receipt and possession of high-level waste; and (3) closure of the repository. The Energy Policy Act of 1992 required the Program to promulgate technical requirements and criteria for the Yucca Mountain, consistent with standards developed by EPA [2]. As a result, the Program has promulgated regulations that define the licensing process, the information required for review, and the dose-based criteria that DOE must meet both for a generic repository and for a Yucca Mountain repository [3-4].

All the regulations necessary to meet the Program goals have been issued or are in the process of being issued. In 2001, the Program promulgated the final regulations for Yucca Mountain, consistent with EPA standards [5]. In 2004, the U.S. District Court of Appeals for the District of Columbia Circuit vacated, in part, the EPA standards and NRC regulations for Yucca Mountain [6]. In 2005, EPA and NRC published proposed changes to their rules. The Program is preparing to promulgate final Yucca Mountain regulations after EPA promulgates its final standards [7-8]. The Program is also preparing security-related regulations for Yucca Mountain [9].

The regulatory structure is such that the public would understand how the regulations fit into the overall achievement of the Program goals. The "Licenses" subpart of the Program's regulations identifies the Program's bases for determining safety, common defense and security, and environmental protection. The "Technical Criteria" subpart of the Program's regulations identifies the performance objectives that must be met for the repository. The Program's regulations also contain specific subparts on public health and environmental standards and performance confirmation [3].

Evidence:

Two pieces of legislation identify specific requirements for the NRC with respect to the Program as described in the explanation:

[1] Nuclear Waste Policy Act of 1982, as amended ; Sections 8, 111, pages 4-8 to 4-10 (75-77 of 192);

[2] Energy Policy Act of 1992 ; Section 801, pages 4-85 to 4-86 (152-153 of 192);

The Program has developed Yucca Mountain specific regulations and guidance consistent with statutory requirements:

[3] Part 63 - Disposal of High-level Radioactive Wastes in a Geologic Repository at Yucca Mountain, Nevada ;

[4] Yucca Mountain Review Plan, Revision 2, Final ; July 2003;

[5] Final Rule and Supplementary Information on Disposal High-Level Radioactive Waste in a Proposed Geologic Repository at Yucca Mountain, Nevada ; Federal Register, vol. 66, no. 213, pp. 55732-55816, November 2, 2001;

The 2004 decision in which the U.S. District Court of Appeals for the District of Columbia Circuit vacated, in part, the EPA standards and NRC regulations for Yucca Mountain:

[6] See Nuclear Energy Institute, Inc. v. Environmental Protection Agency, 373 F.3d 1251 (D.C.Cir. 2004);

The revised NRC regulation and EPA standard developed in response to the court decision:

[7] Proposed Rule and Supplementary Information - 10 CFR Part 63, Implementation of a Dose Standard After 10,000 Years ; Federal Register, vol. 70, no. 173, pp. 53313-53320, September 8, 2005;

[8] Proposed Rule and Supplementary Information - 40 CFR Part 197, Public Health and Radiation Protection Standards for Yucca Mountain, NV ; Federal Register, vol. 70, no. 161, pp. 49014-49065, August 22, 2005;

In this document, the Commission directed the staff to prepare a rulemaking to specify post 9/11 security requirements for a geologic repository operations area (GROA):

[9] Meeting SRM-M060315A - Staff Requirements - Briefing on NSIR Programs, Performance, and Plans, April 20, 2006 .

Does the agency regularly collect timely and credible performance information, including information from key program partners, and use it to manage the program and improve performance?

Explanation:

NRC regularly collects credible performance information, including performance information from its principal partner, the Center for Nuclear Waste Regulatory Analyses (CNWRA), and uses it to manage the Program and improve performance. Progress on Program outputs is tracked through an operating plan that is regularly updated and reviewed quarterly by senior management at the Division, Office, and Deputy Executive Director level [1-2]. The Program uses performance information to adjust program priorities, allocate resources, or take other appropriate action. Progress on specific outputs is tagged as "green," "yellow" or "red," as appropriate, and recovery plans are addressed to improve performance, for outputs that need management attention. Activities that are not fully meeting performance goals are tracked quarterly at the Deputy Executive Director level until full performance is restored.

The Program's regular collection of performance information includes performance by the CNWRA, the principal program partner. NRC's contract with the Southwest Research Institute (SwRI) for the CNWRA is a performance-based cost-plus-award-fee type of contract [3]. Every four weeks, CNWRA submits a Program Manager's Progress Report as required by the CNWRA contract with NRC. This report provide the current status of each major area of CNWRA's plan of technical work, as well as management issues, major problems, and a summary of the financial status [4]. Program and CNWRA managers meet regularly to address financial performance and make appropriate adjustments to CNWRA's plan of work. For example, if fewer DOE reports are received for review than expected, managers will increase the amount of CNWRA independent study.

Monthly, the Program and CNWRA discuss the status of CNWRA products, particularly those scheduled to be completed in the next 60 days, during a "Commitment Control Log Meeting." This provides a forecast of potential impacts on Program milestones [5].

Program-wide oversight of CNWRA activities and performance is done by the Center Review Group, which consists primarily of senior NRC managers from within and outside the Program. This group meets semiannually to review and evaluate the CNWRA's performance. The CNWRA has received "excellent" ratings for its performance in the "Technical" and "Management and Staffing" area. Concerns identified by the review group have been resolved by in a timely manner by CNWRA management [6].

The program regularly monitors DOE activities and uses that information to adjust repository program priorities, allocate resources, or take other appropriate management actions. To help ensure the program is focused on those activities important to safety and security, DOE activities are monitored through: (1) the use of NRC on-site representatives; (2) observation of DOE audits of itself and its contractor activities; (3) quarterly NRC-DOE management meetings; and (4) meetings to discuss key technical issues [7-8]. Meetings between NRC and DOE are open to program stakeholders, including members of the public, public interest groups, industry groups, affected units of local government, and the State of Nevada. All public meetings include time set aside for stakeholder comment and NRC meeting feedback forms are provided for written comments.

The program has collected the baseline performance data necessary to set meaningful ambitious performance targets. The Program has retained performance data from FY 2001 and annually revisits its performance targets.

Evidence:

Progress on Program outputs is tracked through operating plans at the office and division levels:

[1] Office of Nuclear Materials Safety and Safeguards Operating Plans for FY 2007 (Official use Only);

[2] Division of High-Level Waste Repository Safety Operating Plans for FY 2007 (Official use Only);

NRC's contract with the Southwest Research Institute (SwRI) for the CNWRA is a performance-based cost-plus-award-fee type of contract:

[3] Contract 02-02-012, "For the Operation of the Center for Nuclear Waste Regulatory Analyses as a Federally Funded Research and Development Center"; (Official use Only);

The Program uses a number of mechanisms to collect performance information from its contractor and principal program partner, including the following two status reports and an annual performance evaluation:

[4] CNWRA Program Manager Periodic Report (produced every four weeks) (Official Use Only);

[5] CNWRA Commitment Control Log Meeting (monthly status of CNWRA commitments) (Official Use Only);

[6] NRC Annual Evaluation of CNWRA Performance (Official Use Only);

The program regularly monitors DOE activities and uses that information to adjust repository program priorities, allocate resources, or take other appropriate management actions. The NRC has established a protocol for interacting with DOE and puts meetings related information on its website:

[7] Agreement Between DOE/OCRWM and NRC/NMSS Regarding Prelicensing Interactions ;

[8] Agendas and meeting reports of NRC-DOE Management Meetings and Technical Exchanges.

Are Federal managers and program partners (including grantees, sub-grantees, contractors, cost-sharing partners, and other government partners) held accountable for cost, schedule and performance results?

Explanation:

Each Program manager is responsible for development, management, and successful implementation of processes to achieve performance goals and outcomes. Manager effectiveness at achieving these performance standards is reflected in the Senior Executive Service (SES), Senior-Level Supervisor (SLS), and Branch Chief performance appraisals, which are used, in part, to determine promotions and awards [1-3]. In FY 2004, the SES appraisals were modified to clearly link individual goals to NRC goals, providing a tangible link between NRC and program goals and manager performance. The Office of Personnel Management (OPM) in collaboration with the Office of Management and Budget (OMB) provided provisional certification of NRC's Senior Executive Service Performance Management System in 2005 [4-7]. Renewal of this certification for 2007 and beyond will be requested in May 2007, and NRC has been working closely with OPM to ensure that the criteria to receive such certification is received. Managers are identified for each Program goal at the operating level, and must develop and implement strategies and measures to meet Program-level outputs and outcomes that roll-up to Strategic Plan goals [8-9]. Managers are held to exacting standards for cost, schedule, and performance results, and they must defer or shed lower-priority work using NRC's Planning, Budgeting, and Performance Management, and common-prioritization processes [10-11].

The primary organizational unit within the Program is the Division of High-Level Waste Repository Safety (HLWRS) within the Office of Nuclear Material Safety and Safeguards (NMSS) [12]. The Division Director has overall responsibility for project management, integration, technical evaluation, and overall coordination of the Program, consistent with the NRC Strategic Plan and associated nuclear waste safety performance goals and strategies [13]. The division has two deputy directors. The Licensing and Inspection Directorate Deputy Director serves as the focal point for implementing the Division's project management activities. The Technical Review Directorate Deputy Director serves as the focal point for the Division's site, engineering, and performance assessment technical review activities. The Division has branch chief's for project management (two), engineering, repository site, and performance assessment. The division assigns responsibility for operating plan activities to specific branch chief and staff members by name [9].

For the Center for Nuclear Waste Regulatory Analyses (CNWRA), the Program's sole partner, the performance-based award-fee contract was established to hold the contractor accountable for cost, schedule, and technical performance, and to stimulate management actions that will motivate CNWRA staff to strive for excellent overall performance [14]. The criteria in the contract that NRC uses to evaluate performance are: (1) Technical: The extent to which the contractor provides high-quality technical assistance and research in support of the Program, including, timeliness, quality and independence, and initiative. (2) Management and Staffing: The extent to which the contractor develops, equips, staffs, and operates a Center capable of meeting NRC's long-term and short-term needs, establishes appropriate priorities, and uses available resources efficiently and effectively. (3) Cost Control and Contract Administration: The extent to which the contractor conducts its work in a cost-effective manner and has controls necessary to ensure that technical work products are completed within established cost limitations.

Evidence:

Program manager promotions and awards are tied to performance as described in the agency procedures, agency forms, and Program examples:

[1] NRC Management Directive 10.137 ; "Senior Executive Service Performance Management System";

[2] NRC Form 351 (Senior Executive Service (SES) Performance Appraisals);

[3] Division of High-Level Waste Repository Safety SES Performance Appraisals (Official Use Only);

The NRC SES Performance Appraisal System received provisional certification from the Office of Personnel Management for calendar years 2004 and 2005. The NRC is addressing recommendations made for 2006 and will apply for full certification in 2007:

[4] Agency Certification Status ; See archive for calendar years 2004 and 2005;

[5] Linda M. Springer letter regarding Full Certification of NRC's SES Performance Appraisal System for Calendar Year 2006-2007; July 14, 2006 (Official Use Only);

[6] Dan G. Blair Memo letter regarding Provisional Certification of NRC's SES Performance Appraisal System for CY 2005; April 13, 2005 (Official Use Only);

[7] Kay Cole James letter regarding Provisional Certification of NRC's SES Performance Appraisal System for 2004; December 17, 2004 (Official Use Only);

Managers are assigned responsibility for meeting Program goals in operating plans, including by name at the division level:

[8] Office of Nuclear Materials Safety and Safeguards Operating Plans for FY 2007 (Official use Only);

[9] Division of High-Level Waste Repository Safety Operating Plans for FY 2007 (Official use Only);

NRC's planning, budgeting, and performance management processes are described in NRC budget documents:

[10] NRC FY2007 Performance Budget (NUREG-1100, Vol. 22) ; Chapter 5, Performance Measurement, pages 84-86;

[11] NRC FY2008 Performance Budget (NUREG-1100, Vol. 23) ; Chapter 5, Performance Measurement, pages 83-85;

The primary organizational unit within the Program, the Division of High-level Waste Repository Safety, is described on the following web page down to the directorate and branch level:

[12] Office of Nuclear Materials Safeguards Functions ; See Division of High-Level Waste Repository Safety;

The NRC strategic plan describes goals and implementing means and strategies the Program is responsible for meeting:

[13] NRC Strategic Plan FY2004-FY2009 ; page 7, see Strategic Outcomes;

The NRC's contract with the Center for Nuclear Waste Regulatory Analyses provide criteria for evaluating contractor performance:

[14] Contract 02-02-012, "For the Operation of the Center for Nuclear Waste Regulatory Analyses as a Federally Funded Research and Development Center"; (Official Use Only).

Are funds (Federal and partners') obligated in a timely manner, spent for the intended purpose and accurately reported?

Explanation:

To ensure that funds are obligated consistent with Program needs, funds are routinely incrementally obligated through the year, when final program requirements are more definite. For instance, if funding needs for a project have changed, subsequent obligations are revised, and funds are reprogrammed within the Program, or returned to the Chief Financial Officer (CFO). At the end of FY 2006, 99 percent of NMSS funds were committed and 94 percent were obligated.

All NRC Program managers have a target of 65 percent for fund obligations by mid-year, and an expenditure target of the total of the number of months remaining in the fiscal year, plus four additional months, to allow ongoing work to continue, uninterrupted into the next fiscal year.

NRC systems for budget execution and the administrative control of funds comply with the requirements set forth in Office of management and Budget (OMB) Circulars, the Antideficiency Act, the Impoundment Control Act of 1974, and the Chief Financial Officers Act of 1990. NRC policies and procedures are documented in NRC Management Directive (MD), Vol. 4, "Financial Management" (i.e., specifically, MD 4.2, "Administrative Control of Funds"). All staff members involved in funds obligation must be designated by name in writing [1].

NRC's recipient of allotments from OMB issues advice on allowance (authority to incur obligations against funds) and financial plan (planned allocation of funds to allowance holders, consistent with the NRC budget) documents, to designated allowance holders [2]. The recipient responsibility at the NRC is delegated by the NRC CFO to the Director of the Division of Planning, Budget, and Analysis. NRC's administrative control of funds process ensures that: (1) funds are used only for authorized purposes; (2) funds are economically and efficiently used; (3) obligations and expenditures do not exceed amounts appropriated, allotted, allocated, and specified as statutory limits; and (4) funds are not reserved nor otherwise withheld, without Congressional knowledge and approval. Obligations are supported by documentation, such as written binding agreements, purchase orders, travel authorizations, grant awards, and similar documents. Obligations are required to be entered into NRC's accounting system, within two workdays. For this Program, there was no identification of any instances of funds not being spent as intended.

The NRC CFO monitors commitments, obligations, and expenditures on a monthly basis, and reports findings in the monthly Budget Execution Report [3]. All managers of contract funds are required to complete formal training/certification requirements. Additionally, contract funds are tracked and reported at the Division (monthly), Office (quarterly), and executive (mid-year) levels of management, to ensure that rigorous accountability, NRC-wide consistency, targets are met, and funds are spent for the intended purpose.

NRC tracks fund usage in computerized financial control systems that allow a forecast of spending through the fiscal year. Measures and/or targets are established for carryover of contract funding, training, and travel resources.

The Program and its principal partner, the Center for Nuclear Waste Regulatory Analyses (CNWRA), set schedules for obligations that properly correspond to the resource needs of the Program plan. CNWRA prepares an annual operating plan in accordance with Program guidance, and reports every four weeks on work and spending, in accordance with the plan [4-6]. Program and CNWRA managers meet bi-monthly to discuss financial and other issues. Funding or spending adjustments are made as needed [7].

Evidence:

NRC has procedures for the administrative control of funds:

[1] NRC Management Directive 4.2 ; "Administrative Control of Funds";

NRC develops financial plans for allocating funds to allowance holders:

[2] Office of Nuclear Materials Safety and Safeguards Operating Plans for FY 2007 (Official use Only);

The NRC CFO monitors commitments, obligations, and expenditures on a monthly basis, and reports findings in the monthly Budget Execution Report:

[3] Monthly NRC Budget Execution Reports (Official use Only);

CNWRA prepares an annual operating plan in accordance with Program guidance, and reports every four weeks on work and spending, in accordance with the plan:

[4] NRC Interim Guidance for the Development of Fiscal Year 2007 Center for Nuclear Waste Regulatory Analyses Operation Plans, August 24, 2006 (Official Use Only);

[5] Draft Fiscal Year 2007 CNWRA Operations Plans for the High-Level Waste Repository, October 13, 2006 (Official Use Only);

[6] CNWRA Program Manager Periodic Report (produced every four weeks) (Official Use Only);

Program and CNWRA managers meet bi-monthly to discuss financial and other issues. Funding or spending adjustments are made as needed:

[7] NRC - CNWRA Management Meeting Reports (Official use Only).

Does the program have procedures (e.g. competitive sourcing/cost comparisons, IT improvements, appropriate incentives) to measure and achieve efficiencies and cost effectiveness in program execution?

Explanation:

The Program does not have at least one efficiency measure with baseline and targets.

The Program has procedures to measure and achieve efficiencies and cost effectiveness in Program execution. In support of the NRC-wide, long-term, effectiveness, performance measure, NRC has developed a procedure for annually identifying efficiency improvements and targets for each NRC program: (1) select and define a candidate process; (2) analyze process for areas in need of improvement; (3) establish targets for efficiency improvements; and (4) report progress annually [1-2]. For the purposes of this measure, a desired efficiency improvement is defined as an improvement or positive change in the process cost, quality, productivity, and/or timeliness. This procedure resulted in a Program efficiency measure for FY 2007-FY 2008, and the Program anticipates developing at least one efficiency measure, each future year, as part of the budget development process.

The Program has procedures in place to achieve efficiencies and cost effectiveness for the design, development, operation, and maintenance of major information technology systems. For example, the Licensing Support Network (a web-based collection of documents relating to the potential repository) was initially developed and operated using a five year General Services Administration (GSA) Schedule contract in 2000. The competition was opened to a substantial number of GSA schedule contract vendors, and a firm fixed price contract was awarded for software purchases, website hosting, and website maintenance, with a cost-reimbursable travel element. The operations and maintenance contract was recompeted in early 2006, again with a number of GSA schedule contract vendors being invited to bid, and a statement of work incorporating performance-based contracting features. This competition resulted in a best-value contract being awarded to the original support contractor, and accordingly, there was no disruption in service.

The Program has a number of procedures and processes designed to measure and achieve efficiencies and cost effectiveness with its contractor. For example, as discussed for Question 3.1, the award fee component of the Center for Nuclear Waste Regulatory Analyses (CNWRA) contract, which covers the quantity, quality, timeliness, and independence of CNWRA work, was established to provide an incentive for the Contractor to perform in an efficient and cost-effective manner [3]. The Defense Contracting Audit Agency conducts annual financial audits of the CNWRA concerning (1) costs-incurred and (2) compliance with OMB Circular A-133 [4]. As part of renewing the contract with the CNWRA every five years, the Program does a cost comparison of leaving the work at the CNWRA or bring the work in-house.

The Program has an efficiency measure that it is baselining in FY 2007 and has set a target for 5 percent improvement. The efficiency measure is related to the pre-licensing issue resolution output measure, which encourages staff to identify potential safety and security issues to DOE in a timely manner. In FY 2007, the Program is re-baselining the implementation of the target for the output measure. For the efficiency measure, the Program has set a quantitative target to reduce the staff cost of preparing letters, to DOE, on significant issues, by 5 percent, from FY 2007 to FY 2008 [2].

Evidence:

The NRC budget documents described the processes the Program uses to annually identify efficiency improvements. The Program has identified an efficiency measure on page 94 for the FY 2008 budget:

[1] NRC FY2007 Performance Budget (NUREG-1100, Vol. 22) ; Appendix 4, pages 171-172;

[2] NRC FY2008 Performance Budget (NUREG-1100, Vol. 23) ; Efficiency Measure, page 94; Appendix 4, pages 172-173;

The award fee component of the CNWRA contract, which covers the quantity, quality, timeliness, and independence of CNWRA work, was established to provide an incentive for the Contractor to perform in an efficient and cost-effective manner:

[3] Contract 02-02-012, "For the Operation of the Center for Nuclear Waste Regulatory Analyses as a Federally Funded Research and Development Center"; (Official Use Only);

The Defense Contracting Audit Agency conducts annual financial audits of the CNWRA concerning (1) costs-incurred and (2) compliance with OMB Circular A-133:

[4] Defense Audit Contract Agency FY2006 Audit of CNWRA, August 4, 2006 (Official Use Only);

(1) Costs incurred audit: Evaluates the total costs billed by the CNWRA to verify that all costs, both direct and indirect, are allowable and are in acceptable cost pools in accordance with standard cost accounting principles.

(2) Compliance with OMB Circular A-133, "Audits of States, Local Governments, and Non-Profit Organizations," Audit: An audit of the Southwest Research Institute's compliance with requirements applicable to major program and on internal control over compliance in accordance with OMB Circular A-133. This audit evaluates internal controls, assesses control risk, assesses accounting principles used, and evaluates the overall data and record presentation.

Does the program collaborate and coordinate effectively with related programs?

Explanation:

The Program coordinates effectively with other agencies (primarily EPA and DOE) that have responsibilities under the overall National high-level waste policy. As noted, the law requires NRC regulations to be consistent with EPA standards for Yucca Mountain. Therefore, NRC has coordinated with EPA on standards and regulations for Yucca Mountain, through the OMB rulemaking coordination process.

The coordination between the Program and DOE has been between a regulator and a potential licensee. DOE is responsible for siting, obtaining a license, constructing, operating, closing, and decommissioning a geologic repository for high-level waste disposal. The Program is responsible for licensing and providing oversight of the geologic repository DOE is developing. To better coordinate and carry out their responsibilities, the Program and DOE developed formal procedures for engaging in public pre-licensing interactions [1]. The pre-licensing interactions focus on identifying significant issues that DOE should address, and the type of information that DOE needs for submitting a high-quality license application. These interactions were anticipated in the Nuclear Waste Policy Act of 1982 to support the statutory timeframe of 3 to 4 years for the Program to make a decision on an authorization to construct a geologic repository [2-3]. The Program and DOE also conduct public senior- management meetings quarterly, to ensure that issues are raised to decision-makers, and that Program resources are properly focused on key DOE activities.

The Program monitors and coordinates with international organizations (e.g., the International Atomic Energy Agency (IAEA) and the Organization for Economic Co-operation and Development Nuclear Energy Agency). The Program helped draft an IAEA safety standard on deep geologic disposal, in recognition of the standard's potential relationship to the Program regulatory framework.

The Program coordinates with State and local programs, particularly in the State of Nevada, the host state for the potential repository at Yucca Mountain. The Program provides workshops, presentations and open houses on its role and activities, in order to inform State and local officials on the issues and how they can participate. The Program provides training to State and local representatives on how to participate in the licensing process and on accessing information, such as how to search for information on the Licensing Support Network (LSN), a web-based collection of documents relating to the potential repository.

The Program shares information with the Nuclear Waste Technical Review Board (NWTRB), an independent, expert technical review panel for DOE high-level waste activities, which reports to the Congress and the Secretary of Energy. The Program frequently makes presentations to the NWTRB on a variety of issues, including technical issues, the regulations, and the licensing process. The Program also attends NWTRB meetings and considers issue raised by the NWTRB. The Program recognizes the importance of the NWTRB, and monitors its work (and, more broadly, all technical work of potential relevance to the Program) to better understand its views. The regulations require a DOE license application to consider all relevant available information on the performance of a potential repository. This includes any unresolved NWTRB safety concern. All such information will be included in NRC's application review.

Evidence:

To better coordinate and carry out their responsibilities, the Program and DOE developed formal procedures for engaging in public pre-licensing interactions:

[1] Agreement Between DOE/OCRWM and NRC/NMSS Regarding Prelicensing Interactions ;

Prelicensing interactions between DOE and NRC were anticipated in the nuclear waste legislation to support the statutory timeframe of 3 to 4 years for the Program to make a decision on an authorization to construct a geologic repository:

[2] Nuclear Waste Policy Act of 1982, as amended ; Sections 8, 111: pages 4-8 to 4-10 (75-77 of 192);

[3] Energy Policy Act of 1992 ; Section 80: pages 4-85 to 4-86 (152-153 of 192).

Does the program use strong financial management practices?

Explanation:

NRC's strong financial management practices governing control of funds and resource allocation are established in procedures and implemented by the program [1-2]. This ensures that funds are used for authorized purposes only, that funds are responsibly, economically, and efficiently used, that the level of funds being committed and obligated is available, and that funds are committed and obligated in the proper time frame. Funds control duties are assigned to a sufficient number of adequately trained program staff who are designated in writing. The staff responsible for fund certification are different from staff responsible for fund commitment and obligation, ensuring an appropriate check and balance in fund management [3-4].

The auditors have not identified any material internal control weaknesses affecting the Program. The program uses agency-wide systems and controls to minimize erroneous payments. On-time payments of approximately 95 percent have been routinely observed; payments associated with this program are included in that figure. Similarly, the rate of improper payments is extremely low and involve only a very small fraction of the total funds, well below Improper Payments Information Act and OMB criteria of both 2.5 percent of program payments and $10 million for high risk; payments associated with the program are included in that figure [5].

The integrated financial and performance management systems supporting the program's day-to-day operations meet statutory requirements. The effectiveness of these practices is reflected in the NRC financial statements that earned an unqualified opinion in FY 2006, with no Agency-wide material weaknesses nor non-compliance with statutory requirements for financial management systems, found in the FY 2006 audit, that impact the Program's financial management or day-to-day operations [6-7].

The Program's financial information is accurate and timely. Annually, the Program certifies that there is reasonable assurance that management controls are achieving their intended results, that resources are being used consistent with the Agency mission, and that resources are protected from waste, fraud, and abuse. The program's certification is reviewed as part of the Office of the Inspector General's annual review regarding the implementation of the Federal Managers' Financial Integrity Act.

NRC has received a clean audit opinion on its FY 2006 financial statements. The identified Agency-wide material weaknesses related to the fee billing system and the Federal Information Security Management Act of 2002 (FISMA) have no impact upon the Program's day-to-day operations, and management of the program's financial resources. To meet Federal accounting requirements, NRC is planning to complete replacement of the License Fee Billing system in FY 2008.

NRC conducts financial and contract management training for all staff on a regular basis. Staff involved in the Program's contract and project management activities must attend acquisition training. NRC's Financial Management Seminar is offered semiannually, and provides an overview of the Federal and NRC budget process, fundamentals of appropriations law, and NRC's financial management policies and procedures.

Evidence:

NRC's strong financial management practices governing control of funds and resource allocation are established in procedures and implemented by the program:

[1] NRC Management Directive 4.2 ; "Administrative Control of Funds";

[2] NRC Management Directive 4.4 ; "Management Controls";

The staff responsible for fund certification are different from staff responsible for fund commitment and obligation, ensuring an appropriate check and balance in fund management:

[3] NMSS reasonable assurance statement, October 3, 2006; (Official Use Only);

[4] NMSS FY 2007 Internal Control Plan, November 2, 2006; (Official Use Only);

The NRC CFO monitors commitments, obligations, and expenditures on a monthly basis, and reports findings in the monthly Budget Execution Report:

[5] Monthly NRC Budget Execution Reports (BER); (Official Use Only);

NRC reports and is audited annually on financial performance:

[6] NRC FY2006 Performance and Accountability Report, Chapter 1 ; Chapter 3, pages 69-105;

[7] OIG-07-A-02, "Results of the Audit of the United States Nuclear Regulatory Commission's Financial Statements for Fiscal Years 2006 and 2005," November 9, 2006.

Has the program taken meaningful steps to address its management deficiencies?

Explanation:

The primary system the Program uses for identifying, evaluating, and correcting program management deficiencies is through issue papers for the Commission. The issue papers are developed in coordination with all the organizational units supporting the Program, to ensure that correction to one unit's deficiencies do not adversely affect other organization units. The Office of the General Counsel reviews issue papers for legal issues and the Chief Financial Officer reviews issue papers with resource implications. The issue papers identify options and recommend courses of action and go through the chief operating officer to the Commission. The Commission makes a decision on the recommended course of action, identifies further actions, including possibly further study and development of the issue, and sets time limits for completing the actions. Recent issue papers involved the direction of the Program [1] and the ongoing viability of the Center for Nuclear Waste Regulatory Analyses (CNWRA) [2], when DOE did not submit a license application, in FY 2005, and did not announce a new license application submittal date. The papers considered strategies for maintaining the technical capabilities of NRC and CNWRA staff in light of the uncertainties from the delay in the DOE license application. The Commission decided that the prelicensing program should be maintained until the NRC had a clearer picture of the direction of DOE's program. For the CNWRA issue paper, the Commission decided that the CNWRA should maintain the core technical expertise needed to support the review of a license application.

Previous issue papers have involved: (1) the formation of a group of qualified, independent technical staff available to advise the Commission in deciding appeals arising from the Program's licensing proceedings [3]; (2) the development of a web-based system to support stakeholders who plan on participating in licensing proceedings to make their documents public for discovery [4]; and (3) the development of a functioning information system that supports a full electronic hearing, including the electronic submittal and exchange of information [5]. The Program anticipates developing additional issue papers on the operation of CNWRA and future rulemakings.

Another way to identify and correct Program management deficiencies is through annual public Program briefings of the Commission. These Commission briefings typically involve a discussion of Program accomplishments, challenges, and issues for Commission attention. The Commission provides formal feedback and direction to the Program, after the briefing. For example, the Commission directed the staff to develop a means, and supporting technical basis, for ranking the importance of technical issues to the safe, secure performance of the repository. The Program developed and used the rankings, to set priorities to improve effectiveness, in scheduling and resource allocation, in addressing technical issues.

Evidence:

The following two issue papers represent recent examples of the Program developing issues papers to bring potential management deficiencies to the attention of senior management and the Commission and to identify potential solutions:

[1] SECY-06-0103, The U.S. Nuclear Regulatory Commission High-Level Waste program Direction for Fiscal Years 2006 and 2007, May 8, 2006, (Official Use Only);

[2] SECY-07-0007, Recommendation and Status Report Regarding Proposed Expansion of the Center for Nuclear Waste Regulatory Analyses Charter to Include Work Outside The Nuclear Waste Policy Act, January 5, 2007 (Official Use Only);

Previous issues papers cited in the explanation:

[3] Staff Requirements - SECY-03-0120 - Response to SRM Dated June 11, 2002: Recommendations and Progress in Identifying Commission Adjudicatory Employees for the Adjudication of a License Application for a Yucca Mountain High Level Waste Repository, November 25, 2003 (Official Use Only);

[4] Licensing Support Network Program Administration -Semiannual Report ; SECY-07-0018, January 12, 2007;

[5] Initial Operation of Integrated Business Systems for High-Level Waste Proceedings ; SECY-05-0145, August 10, 2005.

Did the program seek and take into account the views of all affected parties (e.g., consumers; large and small businesses; State, local and tribal governments; beneficiaries; and the general public) when developing significant regulations?

Explanation:

NRC's rulemaking process proactively seeks and takes into account the views of the public and stakeholders, through public notifications, public meetings, and petitions for rulemaking. An Advance Notice of Proposed Rulemaking or an issues paper published in the Federal Register obtains comments on regulatory actions under consideration. All proposed rules are published for public comment. Although only one entity, DOE, will be regulated under this Program, a number of other stakeholders exist, and were involved in the rulemaking process.

The draft rules were coordinated with the other Federal agencies (DOE and EPA) through the OMB process. Many different stakeholders, including DOE, EPA, the State of Nevada, the nuclear power industry (individually and through its advocacy group, the Nuclear Energy Institute), affected units of local government, public advocacy groups, and individuals, provided comments on the proposed regulations. In the Federal Register notices promulgating the final rules, NRC describes the comments received, indicates whether the comments were incorporated into the final rule, and explains when comments are not incorporated. This process of seeking public comments and either incorporating or addressing public comments with the final rule was followed for Program-related rulemakings.

The proposed regulations for a site-specific geologic repository at Yucca Mountain had an extended (120-day) public-comment period, including five public meetings in Nevada. The primary regulations for the proposed Yucca Mountain repository are in 10 CFR Part 63. Comments and revisions were also included for portions of 10 CFR Parts 2, 19, 20, 51, 70, 72, 73, and 75, which were revised to reference Part 63. More than 700 discrete comments in about 160 individual letters were received, reviewed, and considered in preparing the final rule. An additional 193 comments from public meetings were also identified and evaluated. Comment responses were provided in the supplementary information published with the final rules in the Federal Register [1-2].

NRC regulations under the National Environmental Policy Act are contained in Part 51, and were updated for licensing of a geologic HLW repository at Yucca Mountain in 2001, after an opportunity for public comment. NRC is currently considering a petition, from the State of Nevada, for further revision [3-4].

Stakeholders were further involved in the amendment to Part 63, to specify the probability of unlikely features, events, and processes. Comments from five stakeholder organizations were received during a 75-day comment period; these were reviewed and addressed in the Federal Register [5].

A further rulemaking was completed, in 2004, that amended NRC "Rules of Practice for Licensing Proceedings" on high-level waste disposal in a geologic repository. These amendments primarily concerned use of the Licensing Support Network (LSN) and the Electronic Hearing Docket (EHD). Nine stakeholder comments on these procedural amendments were received, reviewed, and addressed in the Federal Register [6-7].

These are the only relevant completed rulemakings for the Program. In response to the July 2004 ruling, by the U.S. District Court of Appeals for the District of Columbia Circuit, EPA has proposed a revision of 40 CFR Part 197, to include a compliance period greater than 10,000 years. A revision to Part 63 has been proposed, to be consistent with the revised EPA standard [8]. The public comment period is closed for both the EPA standard and the revised Part 63. NRC will issue final regulations after EPA issues its final standard. The Program is also preparing a rulemaking to specify post-9/11 security requirements for a geologic repository operations area (GROA). The Program began the GROA rulemaking in FY 2007 and anticipates completing the rule in FY 2008 [9].

Evidence:

Comment responses for the initial promulgation of 10 CFR Part 63 were provided in the supplementary information published with the final rules in the Federal Register. The final rule is also available on the NRC website:

[1] Final Rule and Supplementary Information on Disposal High-Level Radioactive Waste in a Proposed Geologic Repository at Yucca Mountain, Nevada ; Federal Register, vol. 66, no. 213, pp. 55732-55816, November 2, 2001;

[2] Part 63 - Disposal of High-level Radioactive Wastes in a Geologic Repository at Yucca Mountain, Nevada ;

The State of Nevada is requesting that the NRC amend the regulation that governs adoption of an environmental impact statement prepared by the Secretary of Energy in proceedings for issuance of a construction authorization or materials license with respect to a geological repository. NRC environmental regulations and the status of the petition for rulemaking are available on the NRC website:

[3] Part 51 - Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions ;

[4] State of Nevada Petition for Rulemaking, Docket Number PRM-51-9 ;

Comment responses for the revision of 10 CFR Part 63 to specify the probability of unlikely features, events, and processes were provided in the supplementary information published with the rule revision in the Federal Register:

[5] Final Rule and Supplementary Information on Specification of a Probability for Unlikely Features, Events and Processes ; Federal Register, vol. 67, no. 195, pp. 62628-62634, October 8, 2002;

Comment responses for the amendment to the NRC "Rules of Practice for Licensing Proceedings" on high-level waste disposal in a geologic repository were provided in the supplementary information published with the amended rule in the Federal Register. The amended rule is also available on the NRC website:

[6] Final Rule and Supplementary Information on Licensing Proceeding for a High-Level Radioactive Waste Geologic Repository ; Federal Register, vol. 69, no. 113, pp. 32836-32849, June 14, 2004;

[7] Part 2 - Rules of Practice for Domestic Licensing Proceedings and Issuance of Orders ;

The Program sought comments on the proposed revision to 10 CFR Part 63 concerning the implementation of a dose standard after 10,000 years:

[8] Proposed Rule and Supplementary Information - 10 CFR Part 63, Implementation of a Dose Standard After 10,000 Years ; Federal Register, vol. 70, no. 173, pp. 53313-53320, September 8, 2005;

In this document, the Commission directed the staff to prepare a rulemaking to specify post 9/11 security requirements for a geologic repository operations area (GROA):

[9] Meeting SRM-M060315A - Staff Requirements - Briefing on NSIR Programs, Performance, and Plans, April 20, 2006 .

Did the program prepare adequate regulatory impact analyses if required by Executive Order 12866, regulatory flexibility analyses if required by the Regulatory Flexibility Act and SBREFA, and cost-benefit analyses if required under the Unfunded Mandates Reform Act; and did those analyses comply with OMB guidelines?

Explanation:

NRC is in full compliance with the requirements of the Small Business Regulatory Enforcement Fairness Act (SBREFA) and the Regulatory Flexibility Act, for applicable rulemakings. As an independent agency, NRC is not bound by the Unfunded Mandates Reform Act nor for the most part, by Executive Order 12866. The requirements in the Executive Order, to regularly post the overall regulatory agenda, are the one exception, which NRC undertakes in full compliance with the Order. However, as a matter of normal practice, NRC performs cost-benefit analyses, on proposed rules, that are not on matters of immediate safety concern. The Agency guidelines for regulatory analysis are in compliance with OMB's guidance for regulatory analysis, Circular A-4 [1]. The Program has procedures and guidance, in place, to ensure compliance, as described in the evidence [1-2].

The Program issued Part 63, "Disposal of High-Level Radioactive Waste in a Proposed Geologic Repository at Yucca Mountain, Nevada," in 2001 [3]. Part 63 is the primary regulation used by the Program to accomplish its safety goals. The regulatory analysis provides a statement of need for the regulation. The need for the regulations is provided by the Energy Policy Act of 1992 (EnPA), which requires EPA to promulgate public health and safety standards for Yucca Mountain and for NRC to incorporate these standards in to it regulations [4]. Because of the statutory directives in EnPA, NRC does not have the option of examining and selecting appropriate types and levels of public health and safety standards. For this reason, this analysis does not examine the costs/benefits of varying the type and level of repository performance standards or of using non-regulatory approaches [5].

The regulatory analysis did consider two regulatory alternatives in implementing the EnPA: (1) promulgate a new, separate part of NRC regulations, Part 63, that would apply only to Yucca Mountain, leaving existing regulations (Part 60) as written; and (2) promulgate revisions to Part 60, to apply only to Yucca Mountain, eliminating any generic regulations. NRC chose the first alternative for several reasons: (1) The first alternative is the most direct way of establishing site-specific standards for Yucca Mountain in accordance with EnPA; (2) The first alternative is the most timely; (3) The first alternative leaves a generic standard, Part 60, in place; and (4) The first alternative achieves the objective with the least cost. The Program has also conducted regulatory analyses on the other rulemakings for the Program (described in the response to Question 3.RG1) [6-10].

Evidence:

NRC guidelines on performing regulatory analyses:

[1] Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission, NUREG/BR-0058, Revision 4 ; September 2004;

NRC procedures for the rulemaking process:

[2] NRC Management Directive 6.3 ; "The Rulemaking Process";

The initial promulgation of 10 CFR Part 63 along with supplementary information as published with the final rules in the Federal Register:

[3] Final Rule and Supplementary Information on Disposal High-Level Radioactive Waste in a Proposed Geologic Repository at Yucca Mountain, Nevada ; Federal Register , vol. 66, no. 213, pp. 55732-55816, November 2, 2001;

The need for the regulations is provided by the Energy Policy Act of 1992 (EnPA), which requires EPA to promulgate public health and safety standards for Yucca Mountain and for NRC to incorporate these standards in to it regulations:

[4] Energy Policy Act of 1992 ; Section 801: pages 4-85 to 4-86 (152-153 of 192);

The regulatory analysis for the initial promulgation of 10 CFR PART 63:

[5] Regulatory Analysis for Part 63, Disposal High-Level Radioactive Waste in a Proposed Geologic Repository at Yucca Mountain, Nevada ; July 10, 2001;

Additional Program rulemakings as published in the Federal Register along with their regulatory analyses:

[6] Final Rule and Supplementary Information on Specification of a Probability for Unlikely Features, Events and Processes ; Federal Register, vol. 67, no. 195, pp. 62628-62634, October 8, 2002;

[7] Regulatory Analysis for Amendment to Part 63 on Specification of a Probability for Unlikely Features, Events and Processes ; July 17, 2002;

[8] Final Rule and Supplementary Information on Licensing Proceeding for a High-Level Radioactive Waste Geologic Repository ; Federal Register, vol. 69, no. 113, pp. 32836-32849, June 14, 2004;

[9] Proposed Rule and Supplementary Information - 10 CFR Part 63, Implementation of a Dose Standard After 10,000 Years ; Federal Register, vol. 70, no. 173, pp. 53313-53320, September 8, 2005;

[10] Regulatory Analysis for Amendment to Part 63, Implementation of a Dose Standard After 10,000 Years ; August 30, 2005.

Are the regulations designed to achieve program goals, to the extent practicable, by maximizing the net benefits of its regulatory activity?

Explanation:

The regulations are designed to achieve Program goals, to the extent practicable, by maximizing the net benefits of its regulatory activity. The Program's risk-informed performance-based regulations permit DOE to use the most efficient approaches to ensure protection of public health, safety, security, and the environment, consistent with the current state of knowledge [1]. This is because, with risk-informed, performance-based regulations, the safety criteria are focused on potential health effects (i.e., doses, to individuals), as opposed to mitigating pre-selected scenarios, some of which may be of limited risk-significance at Yucca Mountain. Also, the regulations allow DOE to demonstrate the integrated performance of the repository as a whole, rather than meeting performance criteria for individual engineered and natural components of the repository, potentially allowing DOE to develop a more overall effective repository.

For the part of its regulations most closely tied to its safety goals, the public health and safety standards, the Program was restricted to one alternative by the Energy Policy Act of 1992 [2]. The statute required that NRC's regulations be consistent with standards established by EPA for Yucca Mountain. EPA's standards must prescribe the maximum annual effective dose equivalent, to individual members of the public, from releases to the accessible environment, from radioactive materials stored or disposed of in the repository. EPA's standards must be based on, and consistent with, the findings and recommendations of the National Academy of Sciences. Since the Program did not have the option of examining and selecting appropriate types and levels of public health and safety standards (apart from commenting on the EPA proposed standards), the Program did not examine the costs/benefits of varying the type and level of repository performance standards [3-5].

Evidence:

The initial promulgation of 10 CFR Part 63 along with supplementary information as published with the final rules in the Federal Register:

[1] Final Rule and Supplementary Information on Disposal High-Level Radioactive Waste in a Proposed Geologic Repository at Yucca Mountain, Nevada ; Federal Register , vol. 66, no. 213, pp. 55732-55816, November 2, 2001;

For the part of its regulations most closely tied to its safety goals, the public health and safety standards, the Program was restricted to one alternative by the Energy Policy Act of 1992

[2] Energy Policy Act of 1992 ; Section 801: pages 4-85 to 4-86 (152-153 of 192);

Regulatory analyses have been conducted for the Program's rulemakings:

[3] Regulatory Analysis for Part 63, Disposal High-Level Radioactive Waste in a Proposed Geologic Repository at Yucca Mountain, Nevada ; July 10, 2001;

[4] Regulatory Analysis for Amendment to Part 63 on Specification of a Probability for Unlikely Features, Events and Processes ; July 17, 2002;

[5] Regulatory Analysis for Amendment to Part 63, Implementation of a Dose Standard After 10,000 Years ; August 30, 2005.

Has the program demonstrated adequate progress in achieving its long-term performance goals?

Explanation:

The Program is making adequate progress and is on track to meet all long-term performance goals, because it is meeting output-based measures, detailed beginning in the next paragraph, that function as the Program's long-term (and annual) measures.

The Program is meeting its output measure to establish stringent regulations and guidance needed to make a timely decision on DOE's repository license application. Risk-informed, performance-based regulations were issued [1], as well as final guidance [2], on implementing them. After the U.S. Court of Appeals overturned a portion of the regulations (and EPA's Yucca Mountain standard), the Program issued proposed modifications [3], and will issue the final modifications, following EPA's final revised Yucca Mountain standard. The foregoing measure helps assure a regulatory system is established, and improved as needed, using sound science and risk informed, performance based regulations.

The Program is meeting its output measure to assure that high-level waste safety technical reviewers are qualified, after completing training and a formal qualification process [4]. The Program is meeting the output measure to ensure the electronic system (i.e., the "HLW Meta System") meets service level requirements for availability and reliability, and necessary information technology information management systems and business processes are in place. The Program is meeting the output measure to ensure technical information in NRC's high-level waste documentary material is electronically available, as required [5-6]. The foregoing three measures help assure that qualified review staff, trained to apply sound science, will be available, and regulatory system infrastructure is ready when needed.

The Program is meeting output measures to resolve key technical issues, and to conduct observation audits of DOE quality assurance [4-6]. The foregoing two measures contribute to identifying significant technical issues, important to repository safety and security, and thus help ensure safety issues are anticipated and resolved.

Therefore, as discussed under Question 2.1, because the output measures, which the Program is meeting, mirror long-term strategies and means in the Agency's Strategic Plan, they accordingly indicate the Program is making significant progress toward meeting its goal of establishing a regulatory system for the repository, to ensure the repository achieves long-term safety and security goals when (and if) it begins operating possibly in 2017.

With respect to achieving the Program's two specific, long-term, performance measures related to openness and effectiveness; the Program is making Program documentation available to the Licensing Support Network (LSN) [7]. Because Program information is available, stakeholders are informed of Program activities, to support their involvement, as appropriate. Further, the Program established the capability for independent technical advice [8], and established information technology and information management systems and business processes, including system service-level requirements, necessary to efficiently conduct hearing and pre-hearing activities on any repository license application [9]. These activities support stakeholder involvement and timely decision-making on repository safety and security issues. Finally, the Program has met statutory milestones to provide comments on DOE's site recommendation [10], environmental impact statement [11-12], and site characterization program, providing additional evidence of progress toward meeting long-term effectiveness measures.

The principal Program partner, the Center for Nuclear Waste Regulatory Analyses (CNWRA), plays a continuing, key supporting role for the Program's achievement of long-term performance goals. By contract, CNWRA is committed to an exclusive role to support Program activities, as further detailed through annual operating plans [13].

Evidence:

The Program is making progress on its regulatory framework by establishing regulations and guidance:

[1] Part 63 - Disposal of High-level Radioactive Wastes in a Geologic Repository at Yucca Mountain, Nevada ;

[2] Yucca Mountain Review Plan, Revision 2, Final ; July 2003;

[3] Proposed Rule and Supplementary Information - 10 CFR Part 63, Implementation of a Dose Standard After 10,000 Years ; Federal Register, vol. 70, no. 173, pp. 53313-53320, September 8, 2005;

The Program has substantially met its performance measures as tabulated in division level operating plans:

[4] Division of High-Level Waste Repository Safety Operating Plans for FY 2003 - FY 2007 (Official use Only);

The Program has met its performance measures as tabulated in its budget documents:

[5] NRC FY2007 Performance Budget (NUREG-1100, Vol. 22) ; Program Outputs: pages 63-71; Program Outcomes: Chapter 5, Performance Measurement, pages 88-93;

[6] NRC FY2008 Performance Budget (NUREG-1100, Vol. 23) ; Program Outputs: pages 62-69; Chapter 5, Performance Measurement, pages 87-94;

The program has several significant accomplishments in the areas of openness and effectiveness:

[7] NRC Certification of its Licensing Support Network Document Collection ; July 30, 2004;

[8] Staff Requirements - SECY-03-0120 - Response to SRM Dated June 11, 2002: Recommendations and Progress in Identifying Commission Adjudicatory Employees for the Adjudication of a License Application for a Yucca Mountain High Level Waste Repository, November 25, 2003 (Official use Only);

[9] Initial Operation of Integrated Business Systems for High-Level Waste Proceedings ; August 10, 2005;

[10] NRC's Site Recommendation Sufficiency Comments ; November 13, 2001; NRC's preliminary comments provided an independent indication to the President and the Congress on whether the DOE has acquired, developed, and assembled sufficient information for a license application at the time of DOE's Site Recommendation.;

[11] NRC's Review of DOE's Yucca Mountain Environmental Impact Statement (EIS) ;

[12] NRC Comments on Yucca Mountain Final EIS ; February 4, 2002;

The Program's contractor annually commits to supporting Program goals through its operating plans:

[13] Draft Fiscal Year 2007 CNWRA Operations Plans for the High-Level Waste Repository, October 13, 2006 (Official Use Only).

Does the program (including program partners) achieve its annual performance goals?

Explanation:

The Program is achieving its applicable annual performance goals, and the targets, supported by its partner, the Center for Nuclear Waste Regulatory Analyses (CNWRA), who plays a key role, in accordance with annual performance goals, as directed by the Program (see Question 2.5). By contract, CNWRA is committed to an exclusive role to support Program activities necessary to achieve measures and goals, as further detailed through annual operating plans. Annual performance results are documented in the Green Book [1-2]. By meeting annual measures, the Program is demonstrating progress toward achieving long-term performance goals for any operating repository.

The Program is meeting the annual output measures related to establishing a regulatory framework. The Program issued final regulations [3] and guidance [4], necessary to make a timely decision on DOE's license application for a repository, and the Program is taking timely action to update the regulations and guidance, as needed [5].

The Program is meeting the annual output measures related to preparing for an efficient hearing process. The Program continues to make its document collection available to the Licensing Support Network (LSN) on schedule, thereby keeping stakeholders informed of Program activities, to support stakeholder involvement, as appropriate [6]. The Program completed an Operational Readiness Review for the HLW Meta-System, which integrates the various electronic document handling support tasks for an efficient hearing process, including the LSN. The Meta-System meets Program requirements for adjudicatory support, at the service levels expected during the hearing process. The Program established an electronic hearing docket (EHD), supporting pre-hearing and future hearing adjudicatory activities [7]. The Program established a hearing facility in Las Vegas [8], which is used for prehearing activities until DOE submits the license application. Further, the Program has met measures relating to establishment of independent technical advice, and monitoring of the LSN [9].

The Program is meeting the annual output measures related to pre-licensing safety issue resolution. The Program continues to hold public interactions with DOE to identify and publicly communicate specific technical issues [10]. CNWRA is providing integral technical support, through deliverable work products and direct participation by CNWRA staff. The Program issued major documents, addressing DOE interactions and staff work, including: (1) staff guidance for review of a repository license application (i.e., the Yucca Mountain Review Plan) [4]; (2) the status of issue resolution (i.e., "Integrated Issue Resolution Status Report" and subsequent updates) [11-12]; and (3) criteria for key technical issues most important to repository safety and security (i.e., the "Risk Insights Baseline Report") [13].

The output-focused measures, discussed above, are used in the Program to measure progress through each discrete phase, toward creating a regulatory system that will deliver long-term outcome measures when and if a repository is operational. They are being met, and provide further evidence of progress. The agency's Strategic Plan explicitly recognizes such near-term regulatory steps needed to achieve long-term outcomes. Examples include (1) establishing a licensing and regulatory program; (2) making systematic improvements in the regulatory program; (3) using sound science and risk-informed, performance-based regulations; and (4) anticipating and resolving safety issues. The Plan also defines specific near-term Program steps before the expected DOE application. The Program's annual output measures mirror the near-term steps defined in the Strategic Plan, and thus provide a reliable indication of progress toward the Program's long-term goals.

Evidence:

The Program's annual measures are documented in the Program's budget documents:

[1] NRC FY2007 Performance Budget (NUREG-1100, Vol. 22) ; Program Outputs: pages 63-71;

[2] NRC FY2008 Performance Budget (NUREG-1100, Vol. 23) ; Program Outputs: pages 62-69;

The Program is meeting the annual output measures related to establishing a regulatory framework:

[3] Part 63 - Disposal of High-level Radioactive Wastes in a Geologic Repository at Yucca Mountain, Nevada ;

[4] Yucca Mountain Review Plan, Revision 2, Final ; July 2003;

[5] Proposed Rule and Supplementary Information - 10 CFR Part 63, Implementation of a Dose Standard After 10,000 Years ; Federal Register, vol. 70, no. 173, pp. 53313-53320, September 8, 2005;

The Program is meeting the annual output measures related to preparing for an efficient hearing process:

[6] Order Suspending Monthly Licensing Support Network Supplementation Requirements ; On February 9, 2006, the LSN supplementation requirements were suspended since DOE's collection is not certified. Though not required to, NRC is continuing to supplement its collection on a quarterly basis, which is tracked in a division-level operating plan (Official Use Only);

[7] Initial Operation of Integrated Business Systems for High-Level Waste Proceedings ; August 10, 2005;

[8] ANRC Uses New Facility in Las Vegas, Includes State-of-the-Art Features, October 2005 N&RC article (employee newsletter);

[9] Staff Requirements - SECY-03-0120 - Response to SRM Dated June 11, 2002: Recommendations and Progress in Identifying Commission Adjudicatory Employees for the Adjudication of a License Application for a Yucca Mountain High Level Waste Repository, November 25, 2003 (Official use Only);

The Program is meeting the annual output measures related to pre-licensing safety issue resolution:

[10] Resolution of High-Level Waste Key Technical Issues ;

[11] Issue Resolution Status Report ; NUREG 1762, Rev. 1, April 2005;

[12] Issue Resolution Status Report: Introduction and Summary ; NUREG 1762, Rev. 1, April 2005;

[13] Risk Insights Baseline Report ; April 2004.

Does the program demonstrate improved efficiencies or cost effectiveness in achieving program goals each year?

Explanation:

The Program cannot quantitatively demonstrate improved efficiency or cost effectiveness over the prior year.

The Program implements a continuous improvement process to improve efficiencies or cost effectiveness in achieving goals each year. Examples include investments in information technology information management (IT/IM) systems and business process improvements [1]; reorganizations to de-layer Program management [2]; new review technologies and procedures to improve the pre-licensing process for resolving key technical issues [3-4]; and two new efficiency measures, in FY 2007, for interactions with DOE [5-6]. In FY 2009, when it is anticipated that DOE's license application will be under review, the Program is contemplating a new efficiency measure of 5 percent less than projected of combined contractor and NRC staff resources, to complete major tasks without impacting timeliness and quality [6]. In FY 2007-2008, the Program will update planned licensing milestones and resource estimates, and improve procedures to track labor effort in support of major milestones.

Additionally, the Program's annual performance targets are aimed not only at achieving the Program's long-term safety and security measures, but also at improving the efficiency of the Program's future processing of a DOE license application. For example, the Program, by emphasizing key technical issues before the application [7], is reducing the likelihood of Program requests for additional information from DOE, after the application. Similarly, by investing in IT/IM and business processes improvements, the Program is improving prospects to conduct hearing activities more efficiently after the application [1].

IT/IM and business process improvements are a good example. Facing an unprecedented challenge to process a repository license application and conduct an adjudicatory hearing process, the Program established a HLW Business and Program Integrator (HBPI) in FY 2003, to integrate all Program activities, ensure the completeness of business needs, and ensure that systems exist, or will exist, to meet the need [8]. Confronting many separate Program activities, involving complex multi-year programs, with multiple components requiring significant advanced project planning, the HBPI oversaw development and implementation of an integrated plan [9], guiding execution of the activities, implementing a disciplined project management approach, using an interactive process and ongoing communication with all Program organizations. As a result, the Program successfully met successive, annual output measures for an operational HLW Meta-System (i.e., a collection of Program IT/IM activities), in accordance with established service levels [1].

The Meta-System, by integrating improvements of information-handling capabilities, and by reengineering document processing, positioned the Program for an efficient license review, by saving time and resources in the adjudicatory process. Efficiencies are difficult to quantify, as individual milestones involve widely differing products each year.

Efficiencies can be difficult to measure also because the Program is a "first-of-its-kind," and specific activities change from year to year. The Program improved the efficiency of the process for resolving key technical issues (KTIs) in FY 2005 by categorizing KTI agreements in terms of significance to waste isolation [4]. (Note direct comparison between agreements is complicated by the variable complexity of issues). When KTI agreements with higher significance received higher priority, Program measures showed improvements in schedules met. After DOE delayed the license application in 2005, and budgets were reduced, the Program increased video-conferencing, to reduce travel costs, and increased electronic document handling (e.g., document exchange with CNWRA; stakeholder notification of meetings and documents; document receipt from DOE).

Evidence:

The information technology/information management systems supporting the high-level waste hearings became operational in 2005:

[1] Initial Operation of Integrated Business Systems for High-Level Waste Proceedings ; August 10, 2005;

The Program's current organizational structure is focused on it high-level waste responsibilities:

[2] Office of Nuclear Materials Safeguards Functions ; See Division of High-Level Waste Repository Safety;

The Program has identified risk significant issues to focus its prelicensing and licensing activities:

[3] Risk Insights Baseline Report ; April 2004;

[4] Risk Ranking of Agreements ; 2003;

The program has an efficiency measure on page 94 of the FY 2008 budget:

[5] NRC FY2008 Performance Budget (NUREG-1100, Vol. 23) ; page 94;

The program is tracking internally additional efficiency measures and is considering a new efficiency measure in the FY 2009 budget:

[6] NMSS Efficiencies, Cost Avoidances, Investments, and Performance Measures, February 23, 2007 (Official Use Only);

The Program is working on issues during prelicensing to support a more efficient licensing process:

[7] Resolution of High-Level Waste Key Technical Issues ;

The Program established a HLW Business and Program Integrator (HBPI) in FY 2003, to integrate all Program activities, ensure the completeness of business needs, and ensure that systems exist, or will exist, to meet the need

[8] Appointment of John J. Linehan to Director, High Level Waste Business and Program Integration Staff, Office of Nuclear Material Safety and Safeguards, March 13, 2003 (employee announcement);

The Program developed an integrated plan to put required Program infrastructure in place:

[9] High-Level Waste, Licensing Support Program, Project Plan, June 9, 2004 (Official Use Only).

Does the performance of this program compare favorably to other programs, including government, private, etc., with similar purpose and goals?

Explanation:

The Program is a unique and independent regulatory program [1-2], the performance of which compares very favorably to other Federal programs that regulate hazardous materials and nuclear-defense-related activities. The Program is outcome-based. Its regulations are performance-based, and its approach to repository licensing and oversight is to prevent or mitigate the potential, future events that could challenge Program performance goals, if a repository goes into operation. The Program is risk-informed. It established risk-based regulations, and uses risk-informed criteria to guide licensing and oversight activities [2]. The Program's principal partner is a conflict-of-interest-free Federally Funded Research and Development Center (FFRDC), thereby avoiding use of Federal national laboratories, which might give rise to the appearance of bias [4]. The Program is at the forefront in establishing facilities [5], equipment [6], and staff [7] to carry out adjudicatory activities in an electronic environment. NRC's safety record regarding radiation hazards, as evidenced by the strategic goal measures that are being used by the Program even at this early stage, compare favorably to other safety programs [8-10].

No other Government or private programs exist with similar purposes and goals. The Nation's Program for a geologic repository is the first of its kind. However, the Program compares favorably with Federal programs for regulating other types of waste disposal (e.g., EPA's regulation of the Waste Isolation Pilot Project and hazardous waste disposal; Mine Safety and Health Administration's regulation of underground mines). For example, the Program is free of design flaws which might hinder its ability to effectively focus resources on aspects of the proposed repository that are most important to public health and safety. It has procedures (e.g., competitive sourcing/cost comparisons, information technology improvements) to achieve efficiencies and cost effectiveness in program execution. Program regulations are designed to achieve program goals, to the extent practicable, by maximizing net benefits to both the public and occupational workers. Program partners commit to overall Program goals. The Program is also one of the first, internationally, to establish regulations and guidance, and to achieve a readiness to process a license application for a HLW repository.

Evidence:

The Program has been given unique responsibilities in its authorizing legislation:

[1] Nuclear Waste Policy Act of 1982, as amended ; Sections 8, 111, pages 4-8 to 4-10 (75-77 of 192);

[2] Energy Policy Act of 1992 ; Section 801, pages 4-85 to 4-86 (152-153 of 192);

The Program has established risk-informed, performance-based regulations:

[3] Final Rule and Supplementary Information on Disposal High-Level Radioactive Waste in a Proposed Geologic Repository at Yucca Mountain, Nevada ; Federal Register , vol. 66, no. 213, pp. 55732-55816, November 2, 2001;

The Program has established a conflict-of-interest-free Federally Funded Research and Development Center as its contractor:

[4] Contract 02-02-012, "For the Operation of the Center for Nuclear Waste Regulatory Analyses as a Federally Funded Research and Development Center";

The Program has established leading-edge technology facility, equipment, and staff to carry out adjudicatory activities in an electronic environment:

[5] "NRC Uses New Facility in Las Vegas, Includes State-of-the-Art Features", October 2005 N&RC article (employee newsletter);

[6] Initial Operation of Integrated Business Systems for High-Level Waste Proceedings ; August 10, 2005;

[7] Staff Requirements - SECY-03-0120 - Response to SRM Dated June 11, 2002: Recommendations and Progress in Identifying Commission Adjudicatory Employees for the Adjudication of a License Application for a Yucca Mountain High Level Waste Repository, November 25, 2003 (Official use Only);

The Program's performance is documented in its budget documents and its performance and accountability report:

[8] NRC FY2007 Performance Budget (NUREG-1100, Vol. 22) ; Program Outputs: pages 63-71; Program Outcomes: Chapter 5, Performance Measurement, pages 88-93;

[9] NRC FY2008 Performance Budget (NUREG-1100, Vol. 23) ; Program Outputs: pages 62-69; Program Outcomes: Chapter 5, Performance Measurement, pages 87-94;

[10] NRC Performance and Accountability Reports, FY2000-FY2006 ; Chapter 2.

Do independent evaluations of sufficient scope and quality indicate that the program is effective and achieving results?

Explanation:

The Office of Inspector General (OIG) audit, completed in 2005, covering the Program, found that it satisfies NRC's pre-licensing responsibilities through promulgation and implementation of regulations for reviewing a DOE license application (Part 63), and that the Program is carrying out its pre-licensing functions [1]. The audit report found that the Program did not, however, have a "holistic" communications plan for internal and external stakeholders, especially given the complexity of the issues involved in the Program. In response to this finding and the audit recommendation, the Program developed an integrated communications plan that addressed the issues, and enhanced its public outreach team. OIG's planned audit of the Program, in 2006, was cancelled, after DOE delayed its repository license application. Program management requested an audit of the Program in 2007. Additionally, as described above in Question 2.6, the Commission provided direction on future independent program evaluations, applicable to this Program (and other NRC programs).

OIG regularly audits the Program's key partner, the Center for Nuclear Waste Regulatory Analyses (CNWRA). The last audit, completed in 2002, found that the Program's justification for continued use of CNWRA was satisfactory, and that its oversight and administration of the CNWRA contract were adequate [2]. OIG made no recommendations. A comparable audit is being conducted in 2007. The CNWRA is also audited annually by the Southwest Research Institute's (SwRI's) (CNWRA's parent entity), independent Institute of Quality Systems [3]. Other appropriate evaluations of the Program's principal partner, CNWRA, indicate that CNWRA is effective and achieving results. These include annual program reviews and annual performance-award-fee evaluations that have rated CNWRA performance in the "high-excellent" range, as well as project-specific performance-based reviews, a 5-year evaluation, and determination of the need for the Federally Funded Research and Development Center (FFRDC), periodic reviews and audits by the Defense Contracting Audit Agency, and annual reviews by SwRI, including internal financial audits, annual executive management reviews, and quality assurance audits [4-6].

In addition, the Advisory Committee on Nuclear Waste (ACNW), established in 1988 to provide independent technical advice to the Commission, regularly reports on the status of Program. The ACNW is independent of the NRC staff and reports directly to the Commission, which appoints its members. Its letters and reports document evaluations and recommendations by the Committee, and the steps taken by the Program to correct apparent deficiencies. The Committee, for example, recommended to the Commission that the Program risk-rank key technical issues, which the Program accomplished in response to a subsequent Commission requirement. The ACNW has stated that, on balance, the Program has the necessary capabilities and staff in place to review a potential DOE license application. The most recent Commission briefing, by ACNW, on all NRC waste programs, stressed the overall high quality of Program activities.

Evidence:

The Office of Inspector General (OIG) audit, completed in 2005, covering the Program, found that it satisfies NRC's pre-licensing responsibilities through promulgation and implementation of regulations for reviewing a DOE license application (Part 63), and that the Program is carrying out its pre-licensing functions:

[1] Audit of NRC's High-Level Waste Program (OIG-5-A-10) ; February 24, 2005;

An 2002 OIG audit found that the Program's justification for continued use of CNWRA was satisfactory, and that its oversight and administration of the CNWRA contract were adequate:

[2] OIG Audit of NRC Oversight of CNWRA (OIG-2-A-11) ; May 28, 2002;

The Program's contractor undergoes several internal and external annual audits:

[3] Institute Quality Systems FY2006 CNWRA Quality Assurance Audit ; July 28, 2006;

[4] NRC Annual Evaluation of CNWRA Performance (Official Use Only);

[5] NRC Observation of FY2006 CNWRA Quality Assurance Audit - Summary ;

[6] NRC Observation of FY2006 CNWRA Quality Assurance Audit - Report .

Were programmatic goals (and benefits) achieved at the least incremental societal cost and did the program maximize net benefits?

Explanation:

Program implementation is incomplete, as the License Application has not yet been submitted.

Achievement of Program goals, to date, has had little, if any, adverse societal impacts. And significantly, the Program is positioned to maximize net societal benefits, by designing Program goals to foster a timely determination of a DOE license application, and to implement stringent regulations which, if met by DOE, will provide reasonable assurance of protection of public health and safety and the environment, and security. DOE has not submitted a license application; thus, implementation of the Program regulatory actions is in an early phase. Risk-informed, performance-based Program regulations and guidance provide a clear picture of what information DOE must include in its license application [1-2]. By specifying what DOE must accomplish (but not how), and by aiming at what could go wrong at the repository, how likely it is, and what the consequences are, the regulations and guidance reduce unnecessary regulatory burden. The regulatory analyses supporting the regulations addresses, in more detail, the costs and benefits, and shows that the regulations will achieve a net benefit at the lowest cost, compared to other alternatives [3-5]. The Program proactively seeks feedback from DOE and interested stakeholders, on the impacts of its regulations and implementing guidance, by holding periodic public interactions, and by seeking public comment on guidance applicable to its future review and determination of any DOE license application [6]. The Program updates every three years the OMB clearance for information collection as required by agency procedure Management Directive 3.54, "NRC Collections of Information and Reports Management". The Program last updated its clearance in September 2004 and is on target to complete its next update by October 2007.

Evidence:

The Program's regulatory framework; risk-informed, performance-based regulations and guidance; provides a clear picture of what information DOE must include in its license application:

[1] Final Rule and Supplementary Information on Disposal High-Level Radioactive Waste in a Proposed Geologic Repository at Yucca Mountain, Nevada ; Federal Register , vol. 66, no. 213, pp. 55732-55816, November 2, 2001;

[2] Yucca Mountain Review Plan, Revision 2, Final ; July 2003;

The regulatory analyses supporting the regulations addresses, in more detail, the costs and benefits, and shows that the regulations will achieve a net benefit at the lowest cost, compared to other alternatives:

[3] Regulatory Analysis for Part 63, Disposal High-Level Radioactive Waste in a Proposed Geologic Repository at Yucca Mountain, Nevada ; July 10, 2001;

[4] Regulatory Analysis for Amendment to Part 63 on Specification of a Probability for Unlikely Features, Events and Processes ; July 17, 2002;

[5] Regulatory Analysis for Amendment to Part 63, Implementation of a Dose Standard After 10,000 Years ; August 30, 2005;

The Program proactively seeks feedback from DOE and interested stakeholders, on the impacts of its regulations and implementing guidance, by holding periodic public interactions, and by seeking public comment on guidance applicable to its future review and determination of any DOE license application:

[6] High-Level Waste Disposal Meeting Archive .