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Strategic Plan: Appendix, Fiscal Year 2000 - Fiscal Year 2005 (Vol. 2, Part 2)

• Publication Information
• Foreword

Availability Notice

Table of Contents

• Nuclear Reactor Safety
• Nuclear Materials Safety
• Nuclear Waste Safety
• International Nuclear Safety Support
• Corporate Management Strategies
• Links To Other Planning Documents, Program Evaluations, and Management Challenges
• Cross-Cutting Functions with Other Government Agencies
• Strategic Plan Component Schematic
• Endnotes

Nuclear Reactor Safety

This strategic goal represents the focus of the Nuclear Reactor Safety arena. The goal is to achieve our statutory mission to ensure that civilian nuclear power reactors, as well as non-power reactors, are operating in a manner that adequately protects public health and safety and the environment and that safeguards special nuclear material used in reactors. The NRC regulates 103 civilian nuclear power reactors and 37 non-power reactors.

Under Atomic Energy Commission (AEC) and NRC case law, reasonable assurance of adequate protection of public health and safety is, as a general matter, defined by the Commission's health and safety regulations themselves. That is, unless otherwise provided, there is reasonable assurance of adequate protection of public health and safety when the applicant or licensee demonstrates compliance with the Commission's regulations. The regulations were established using defense-in-depth principles and conservative practices that provide a degree of margin to unsafe levels.

The collective efforts of the NRC and the nuclear industry are needed to maintain safety. The NRC licensees⁽¹⁾ have the responsibility to safely design, construct, and operate civilian nuclear reactors. Regulatory oversight of licensee safety is the responsibility of the NRC. Thus, safe performance reflects the results of the collective efforts of the NRC and the nuclear industry.

Measures

We will use the following measures⁽²⁾ to assess results in achieving the Nuclear Reactor Safety Strategic Goal:

• No nuclear reactor accidents.⁽³⁾

• No deaths resulting from acute radiation exposures from nuclear reactors.

• No events at nuclear reactors resulting in significant radiation exposures.⁽⁴⁾

• No radiological sabotages at nuclear reactors.

• No events that result in releases of radioactive material from nuclear reactors causing an adverse impact⁽⁵⁾on the environment.

These measures represent abnormal occurrences that are reported to Congress and that are critical indicators of whether the strategic goal has been realized. Any occurrence would trigger a self-assessment of the NRC's Nuclear Reactor Safety activities to determine if changes are needed.

The Commission recognizes the risks to the public from nuclear power plant operation. Therefore, in 1986, it promulgated the Safety Goal Policy (51 FR 28044) which expresses an acceptable level of the risk from nuclear power plant operation by comparison with other societal risks. Notwithstanding that risk is inherent in reactor operations, the first three measures are being used as indications of whether we are achieving the strategic goal of preventing radiation-related deaths or illnesses. The fourth measure indicates whether radiological sabotages have occurred since such acts could result in core damage, radioactive releases, and significant radiation exposures. Lastly, we will measure how well the environment is protected by whether offsite releases have occurred that caused an adverse impact on the environment.

Maintaining safety, protection of the environment, and the common defense and security is the preeminent performance goal and takes precedence over all other performance goals. In working toward this goal, the NRC will apply its Principles of Good Regulation. Principles applicable to this goal are related to independence, openness, efficiency, regulatory clarity, and reliability.

The safety performance of the nuclear power industry has improved substantially over the past ten years, and nuclear reactors, collectively, are operating above acceptable safety levels consistent with the agency's Safety Goal Policy. The NRC believes this level will be maintained. If substantial safety improvements are identified, additional requirements should only be imposed consistent with the Commission's Backfit Rule (10 CFR 50.109). Allowing small-risk increases⁽⁶⁾ may be acceptable when there is sufficient conservatism and reasonable assurance that sufficient defense-in-depth and safety margins are present. Small-risk changes that reduce unnecessary burden will allow more efficient use of licensee and the NRC resources as well as bring into focus those areas that are more critical to the safety of the public and environment. We will use the body of domestic and international knowledge, experience, and research to determine when changes that could affect risk are acceptable.

The NRC licensees will continue to have the primary role in maintaining safety and are expected to identify, through mechanisms such as operating experience feedback and integrated risk assessments, the design and operational aspect of their plants that should be enhanced to maintain acceptable safety performance levels. For nuclear power plants to continue operating, safety performance must be at or above acceptable levels. The NRC will take action to improve safety performance before it falls below acceptable levels and will require the shutdown of plants when their safety performance is identified as unacceptable. This principle is inherent in the NRC's new oversight process.

Strategies

The NRC will employ the following strategies to maintain safety, the protection of the environment, and promote the common defense and security:

• We will sharpen our focus on safety to include a transition to a revised NRC reactor oversight program for our inspection, assessment, and enforcement activities.

We will increase the focus of inspections on those activities with the greatest potential impact on safety through the new reactor oversight program. Inspection results will be evaluated routinely to determine the risk importance of the findings. These inspection results will be used along with pre-defined performance indicators (e.g., safety system unavailability) to provide an assessment of a licensee's safety performance. This assessment process is expected to be more objective, predictable, and risk-informed than the method previously in place. Allegations regarding licensee performance will be appropriately and objectively addressed in a timely manner. Allegations of potential wrongdoing will be thoroughly and objectively investigated in a timely manner. Enforcement sanctions for violations of regulatory requirements will be commensurate with the safety significance. The enforcement program is also being changed to be better linked to the safety significance of inspection findings and to emphasize the importance of the licensee's corrective action program. The improved safety performance of the nuclear industry is reflected in this strategy as discussed in the first two Major External Factors. We will coordinate with DOL and DOJ regarding discrimination and civil enforcement actions as reflected in the section on Cross-cutting Functions With Other Government Agencies.

• We will respond to operational events involving potential safety or safeguards consequences.

We will provide timely, accurate, and complete assessments of events by evaluating recommendations of the licensees for actions to protect the public and by coordinating with other federal agencies, state and local governments, and the licensee. We will maintain and operate a continuously staffed Incident Response Operations Center to support the agency in responding to operational events. We will conduct periodic exercises to ensure that response organizations are proficient and experienced and that staff are trained to respond to operational events according to their safety significance. We will also maintain incident investigation capabilities. We will work closely with FEMA, DOE, EPA, USDA, HHS, NOAA, and State Governments to maintain incident response capabilities and during actual incident response under the Federal Radiological Emergency Response Plan. We will work closely with FBI and CIA for response to a suspected terrorist or criminal initiated threat or incident. These alliances are reflected in the section on Cross-cutting Functions With Other Government Agencies.

• We will evaluate operating experience and the results of risk assessments for safety implications.

We will evaluate the risk significance of operational events and trends in data in conjunction with risk assessments so that safety vulnerabilities can be identified, prioritized, communicated, and resolved on a timely basis. Operational experience will also be used by the staff to improve our regulatory activities including licensing, inspection, and risk assessments. We will also review operating experience of foreign plants for safety insights. We will monitor for potential adverse effects on nuclear safety from the economic deregulation and restructuring of the electric power industry.

• We will identify, evaluate, and resolve safety issues, including age-related degradation, and ensure that an independent technical basis exists to review licensee submittals to ensure that safety is maintained.

We will conduct research to improve our knowledge in areas where uncertainties in our knowledge exist and may be significant to risk and where safety margins are not well characterized. Priorities for these activities will consider risk significance and cost/benefit analyses. For example, we will evaluate potential degradation of plant systems as they age and ensure that data and methods, including international lessons learned, are available to evaluate this degradation and the effectiveness of corrective strategies. We will continue our international efforts to collect and evaluate information that contributes to the efficient resolution of domestic safety issues. We will conduct research in cooperation with domestic and international entities to ensure that an adequate independent technical basis, as well as related codes, standards, and methods, exists to review and approve licensee or industry proposals. This will be especially important as new technologies are introduced. For complex technical issues, we will develop a better understanding of existing safety margins, resulting in more informed regulatory decisions. We will maintain our program for generic safety issue prioritization based on consideration of potential risk reduction and cost.

• We will ensure that changes to operating licenses and exemptions to regulations maintain safety and meet regulatory requirements.

We will issue license amendments and approve license transfers for nuclear reactors only after determining that there is reasonable assurance that the authorized activities can be conducted without endangering the health and safety of the public and the environment. This includes emergency planning, physical protection, quality assurance, training, financial assurance, and other requirements. We will give priority to those licensing actions and exemptions that provide the greatest safety benefit to the public. We will maintain an effective regulatory infrastructure to assure maintenance of safety during the construction of envisioned advanced reactors and we will encourage applicants, vendors, and others to inform the NRC at the earliest opportunity of planned future reactor activities so that we will be prepared to respond.

• We will ensure that safety is maintained as licenses are renewed by ensuring that aging effects will be adequately managed and that the licensing basis related to the present plant design and operation will be maintained.

We will authorize license renewal only after we have determined that aging effects have been and are being adequately managed. We will ensure that the licensing basis related to the present plant design and operation will be maintained throughout the period of extended operation. We will perform inspections to support the review of license renewal applications by verifying the acceptability of licensee aging management control processes.

• We will maintain safety by ensuring that operator licenses are issued and renewed only to qualified individuals.

We will maintain an operator licensing program for the issuance and renewal of licenses to operators and senior operators of nuclear reactors. The NRC licenses will only be issued to individuals following a finding of adequate health and successful demonstration of their ability to operate a facility competently and safely and, additionally, in the case of senior operators, a demonstrated knowledge of directing the licensed activities of licensed operators competently and safely.

• We will continue to develop and incrementally use risk-informed and, where appropriate, less prescriptive performance-based regulatory approaches to maintain safety.

Stated succinctly, risk-informed, performance-based regulation is an approach in which insights, engineering analysis and judgment, and performance history are used to (1) focus attention on the most important activities, (2) establish objective criteria based on risk insights for evaluating performance, (3) develop measurable or calculable parameters for monitoring system and licensee performance, and (4) focus on the results as the primary basis of regulatory decision-making.⁽⁷⁾As part of our agency- wide Risk-Informed Regulation Implementation Plan (to be completed by FY 2001), we will implement an incremental approach to risk-informing the reactor oversight process and risk- informing the scope of 10 CFR Part 50. We will also assess the technical requirements associated with 10 CFR Part 50 and make changes to ensure that safety is maintained by sustaining our regulatory focus on plant equipment and technical requirements that contribute to nuclear reactor safety. We will consider and use international experience in developing approaches to risk-inform our regulations. Mindful of the limitations in risk assessment methods, we will improve these methods and tools in areas where there needs to be a better understanding of contribution to plant risk through research and through cooperative programs with international partners.

Measures

The NRC will use the following measures⁽²⁾ to assess results in our efforts to maintain safety, and protection of the environment, and promote the common defense and security:

• No more than one event per year identified as a significant precursor of a nuclear accident.⁽⁸⁾

• No statistically significant adverse industry trends in safety performance.⁽⁹⁾

• No events resulting in radiation overexposures⁽¹⁰⁾ from nuclear reactors that exceed applicable regulatory limits.

• No more than three releases per year to the environment of radioactive material from nuclear reactors that exceed the regulatory limits.⁽¹¹⁾

• No breakdowns of physical security that significantly weaken the protection against radiological sabotage or theft or diversion of special nuclear materials in accordance with abnormal occurrence criteria.

The threshold for a reportable event is more stringent for performance goal measures than the strategic goal measures. They provide the opportunity to detect programmatic weaknesses before the strategic goals would be exceeded. However, since target values are numbers of events reported, the targets for strategic goal measures could be exceeded without exceeding performance goal measures which allow a higher number of events (e.g., a substantial event could cause NRC to exceed the no event target value for the strategic goal measure, but not exceed the target value for the performance goal measure which has a target value greater than zero. Accidents that involve substantial core damage or a release of radionuclides can be minimized by maintaining a low frequency of events that have the potential to lead to a nuclear reactor accident or large early release; therefore, we will measure such precursor events. To ensure that the nuclear industry as a whole is maintaining safety, we will monitor industry performance to identify any adverse trends. To prevent radiation-related deaths and illnesses, we will measure the number of radiation overexposures. We can measure our effectiveness in protecting the environment by monitoring radiological releases and by preventing radiological sabotage or theft or diversion of nuclear materials. If the metrics are not met, the agency will review its regulatory practices and licensee actions to determine whether corrective action is necessary to maintain safety.

The NRC views building and maintaining public trust and confidence that the NRC is carrying out its mission as an important performance goal for the agency. To reach this goal, the NRC must be viewed as an independent, open, efficient, clear and reliable regulator. This will be accomplished by providing our stakeholders with clear and accurate information about, and a meaningful role, in our regulatory programs. The NRC desires that diverse stakeholder groups (i.e., general public, Congress, NRC licensees, other Federal agencies, States, Indian Tribes, local governments, industry, industry workers, technical societies, the international community, and citizen groups) increasingly recognize that NRC actions assure that public health and safety, the common defense and security, and the environment are, and will remain, adequately protected from hazards resulting from the use of nuclear reactors.

Public concern about nuclear safety has at times been high, particularly for the public who live near nuclear facilities. The methods provided by the NRC for members of the public to express their views have been perceived by some members of the public to be insufficient in some circumstances. This goal reflects the NRC's desire to improve in this area, which would include explaining the NRC's roles and responsibilities and how public concerns are considered.

This performance goal stems from the recognition that the NRC must be candid with the public about reactor safety incidents and issues, provide opportunities for meaningful public participation, and demonstrate through our performance that we are capable, independent, and objective regulators. It also stems from recognition that, while the public may not always agree with NRC actions, public confidence in the NRC is enhanced when the agency consistently carries out its mission in a thorough, disciplined, and timely manner.

Strategies

The NRC will employ the following strategies to increase public confidence:

• We will make public participation in the regulatory process more accessible. We will listen to the public's concerns and involve our stakeholders more fully in the regulatory process.

One of the attributes of strong, fair regulation of the nuclear industry involves consistent and timely public involvement. The agency recognizes the public interest and concern in the proper regulation of nuclear activities, and recognizes its responsibility to provide opportunities for meaningful public interaction and involvement. We will listen to, and be responsive to, requests, inquiries, and concerns from the public. We will consider public views in planning changes and making decisions relating to our practices, rules, and processes through holding open meetings in the vicinity of the nuclear facilities; providing adequate notice of meetings; developing communications plans for major regulatory activities; and holding workshops.

• We will communicate more clearly. We will add more focus, clarity, and consistency to our message, be timely, and present candid and factual information in the proper context with respect to the risk of the activity.

Public confidence in the NRC will be enhanced if information is presented in a manner that is easily understood and placed in its proper safety context. We will respond to the requests, inquiries, and concerns of our stakeholders in a timely, courteous, and professional manner. Whenever possible, we will use quick, personalized forms of contact with our stakeholders. Our communications with the public will be designed to foster greater understanding of the NRC's role in protecting public health and safety and thereby enhancing public confidence in our regulatory program. The information we disseminate, both domestic and international, will be clear, technically sound, accurate, reliable, objective, and timely. We will take full advantage of the Internet and new technology for information dissemination. We will protect the private, proprietary, and classified nature of information. All stakeholders should be able to rely on our statements and information.

• We will continue to enhance the NRC's accountability and credibility by being a well-managed, independent regulatory agency. We will increase efforts to share our accomplishments with the public.

The public's confidence that nuclear power is safe is influenced by the public's perception of the NRC as a well-managed, independent regulator. As part of implementing a Planning, Budgeting, and Performance Management (PBPM) process, we will prepare a Strategic Plan that focuses on desired outcomes and provides visibility to our goals and measures. We will manage to outcomes and establish goals to measure and report on our performance. We will use performance feedback in our planning process, and identify the work necessary to produce the desired outcomes. We will meet our commitments in a predictable and timely manner.

• We will report on the performance of nuclear power facilities in an open and objective manner.

Public confidence is influenced by information about the operation of nuclear facilities. The NRC will collect information about the safety performance of nuclear reactors and report that information objectively to the public. Where licensee performance is outside established criteria, the appropriate remedial action will be communicated to the public. The NRC will communicate to the public the resolution of generic safety issues. The NRC will also report on significant international events and will clearly describe any safety implications applicable to U.S. reactors.

• We will continue to foster an environment in which safety issues can be openly identified without fear of retribution.

Public confidence is enhanced in an environment where safety issues can be raised and addressed without fear of retribution. Examples of how this strategy will be implemented include conducting the 10 CFR 2.206 petition process, responding to allegations and safety conscious work environment concerns, investigating alleged wrongdoing, and implementing the NRC's programs for Differing Professional Opinions and Generic Safety Issues. We will conduct a pilot program to solicit feedback from individuals raising safety issues to assess the NRC's effectiveness of handling of allegations.

Measures

We will use the following measures to assess the results in our efforts to increase public confidence:

• Complete the milestones in the annual Performance Plan relating to collecting, analyzing, and trending information for measuring public confidence.

• Complete all of the public outreaches as scheduled in the annual Performance Plan.

• Complete the milestones specific to the agency allegation program effectiveness assessment plan as identified in the annual Performance Plan.

• Issue Director's Decisions for petitions filed to modify, suspend, or revoke a license under 10 CFR 2.206⁽¹²⁾ within an average of 120 days.⁽¹³⁾

The staff is increasing the number, and improving the quality, of its interactions with external stakeholders. We intend to take advantage of these interactions by requesting feedback from the stakeholders that participate in them. The staff believes that the combination of (1) being more proactive in interacting with external stakeholders, (2) improving our interactions with these stakeholders, (3) improving our responsiveness to stakeholder concerns, and (4) systematically monitoring feedback will allow the staff to assess changes and trends in public confidence.

Public outreach was chosen as a performance measure for public confidence based upon NRC experience from well conducted public outreaches. In response, the need for communication plans is recognized in this Strategic Plan and will be completed in FY 2000. The Annual Performance Plan will identify the specific metrics that will be used in assessing results.

The future focus of the outreach effort for significant regulatory issues will be on keeping the public in the vicinity of the facility informed. The NRC will monitor plant specific activities for issues that meet the significant regulatory issue definition. The process will ensure that appropriate outreach activities are being effectively initiated.

The agency is currently developing an agency allegation program effectiveness plan (to be completed by FY 2002) and has not yet identified the specific milestones for the years covered by this Strategic Plan. Specific milestones will be identified each year in the NRC's Annual Performance Plan. NRC will be developing criteria for the choice of the specific milestones and for the monitoring processes. Milestones for the development and implementation of these criteria and the monitoring process will be included in the Annual Performance Plan, so that progress on this activity will be reported to Congress on an annual basis.

The assumption that the public and other stakeholders will continue to provide substantial feedback to and interact with the NRC to improve our programs and processes is inherent in the above strategies and measures (See Major External Factors).

By maintaining the quality of the technical base for our decisions and by optimizing our regulatory activities, while maintaining safety and increasing public confidence, the NRC will ensure adequate protection of public health and safety and the environment. In working toward this performance goal, the NRC will apply its Principles of Good Regulation, which include improved efficiency, clarity, and reliability.

The cost of most NRC activities and decisions contribute to our licensees' operating and maintenance costs and ultimately are borne by the public. As the electric utility industry is in transition from a rate-regulated to a market-based business environment, the NRC must keep its costs reasonable and predictable by being effective, efficient, and realistic in activities and decision-making while continuing to maintain safety. Effectiveness, efficiency and realism are supported by the analysis and use of domestic and international research results and operational experience.

Feedback from stakeholders, self-assessments, international experience, and research results suggests that we should capitalize on advances in technology, implement efficiencies to improve our internal processes, and improve the quality and bases for decision-making. Feedback and our own analyses suggest that we should improve the consistency and predictability of our regulatory decisions by evolving to a more risk-informed and performance-based approach.

Effectiveness means performing the work necessary to support the NRC missions and goals in a thorough, disciplined, and timely manner. We must periodically challenge the value of NRC programs and activities based on how they contribute to the achievement of goals. Our business processes and regulatory decisions should reflect high standards of quality and be technically sound. Specific

challenges in this regard involve (1) risk- informing the NRC's regulatory programs, (2) preparing to address evolving technologies and a changing regulatory environment including the deregulation of the electric utility industry, and (3) improving the predictability and consistency of agency decisions. We will also pursue international cooperative research in order to leverage our research resources, share research facilities whenever possible, and maintain our involvement in international committees and working groups that can best further our interests and minimize unnecessary duplication of effort.

Efficiency means conducting our work productively and on time. Efficiency can be enhanced by closely examining internal processes to learn from experience, reducing costs, and becoming more timely and predictable in delivery of services and decisions.

The NRC decisions can be made more realistic by eliminating excessive conservatism. Realism is supported by the analysis and use of risk information, domestic and international research results, and operational experience, and by improvements in the timeliness, consistency, and predictability of regulatory decisions and actions.

Strategies

The NRC will employ the following strategies to make NRC activities and decisions more effective, efficient, and realistic:

• We will use risk information to improve the effectiveness and efficiency of our activities and decisions.

As part of our agency-wide Risk-Informed Regulation Implementation Plan (to be completed by FY 2001), we will conduct an integrated evaluation of risk information, inspection findings, operating experience, domestic and international research results, and cost data to identify ways to improve the effectiveness of NRC regulatory requirements, guidance, and processes. We will improve our ability to conduct effective plant safety assessments by employing risk-informed methods and data, including international experiences and approaches, which allow for early identification of changes in plant risk. We will develop the tools and information needed to support realistic (versus overly conservative) decision making. We will ensure that our regulatory focus is on those activities that pose the greatest risk to the public by using Probabilistic Risk Assessment (PRA) techniques and other approaches for differentiating between high- and low-risk activities. To improve efficiency in our use of risk information in our activities and decisions, we will leverage our knowledge of risk information through participation in international regulatory information exchanges and cooperative research programs. We will improve predictability and stability in our use of risk assessment methods through participation in national standards activities. Likewise, we will develop guidance to ensure that the application of risk assessment methods is suitable and that there is consistency in their use in our decision-making process.

• We will make agency decisions based on technically sound and realistic information.

We will focus resources in those areas where important gaps in information still exist, where uncertainties exist about the significance to risk, and where the degree of conservatism in safety margins has not been quantified. Insights gained from the maturity of the nuclear industry will be recognized. We will maintain tools and methods used for decision-making that reflect recent scientific information and consider remaining uncertainties. We will ensure that our decisions on significant safety issues are supported by high-quality expertise, experiments, data, tools, and methods.

• We will anticipate challenges posed by the introduction of new technologies and changing regulatory demands.

We will seek information, both domestic and international, about new technologies and will develop the knowledge and tools to evaluate the implications of these new technologies on the safety of nuclear reactors. In addition, we will participate in international regulatory information exchanges and cooperative research programs and will exchange information with universities to leverage resources and share research facilities. Mindful of our respective roles, we will seek opportunities to interact with and, where appropriate, initiate cooperative programs with industry and the international community to minimize duplication. We will take these steps to ensure that our regulatory process does not impede the use of new technology to improve safety, increase productivity, or reduce costs.

• We will identify, prioritize, and modify processes based on effectiveness reviews to maximize opportunities to improve those processes.

We will explore opportunities to prioritize work. We also will systematically review key business processes and will document, standardize, measure, and track, and then analyze and improve the core processes that are critical to achieving our outcomes. We will seek opportunities for improvement and continue to apply lessons learned including that from the revised reactor oversight program and other risk-informed initiatives to improve the efficiency and effectiveness by bringing coherence among these programs. We will modify our regulatory processes to keep pace with the challenges associated with the economic deregulation of the electric power industry.

Measures

The NRC will use the following measures to assess results in our efforts to make NRC activities and decisions more effective, efficient, and realistic:

• Complete those specific reactor milestones in the Risk-Informed Regulation Implementation Plan identified for completion in the annual Performance Plan.

• Complete at least two key process improvements per year in selected program and support areas that increase efficiency, effectiveness, and realism.

• Complete all license renewal application reviews within 30 months.

These measures are intended to help us assess our progress in improving the efficiency of the NRC's operations, increasing the effectiveness of our regulations, and improving realism in our regulatory decisions. Since risk-informed regulation will help improve both our efficiency and effectiveness, the first measure is intended to measure our success in moving toward risk-informed regulation in a timely and integrated manner. The agency is currently developing a Risk-Informed Regulation Implementation Plan (FY 2001) and has not yet identified the specific milestones to be completed during the years cover by this Strategic Plan. Specific milestones will be identified each year in the NRC's Performance Plan. In this way, Congress will be informed in a timely manner of the completion goals of the agency. NRC will be developing criteria for the choice of the specific milestones and for the monitoring processes. Milestones for the development and implementation of these criteria and the monitoring process will be included in the Performance Plan, so that progress on this activity will be reported to Congress on an annual basis. The second measure addresses improvements that simplify, streamline, or improve the timeliness of regulatory processes. The measure of at least two key process improvements per year was selected in addition to the risk-informed measure to focus on other areas to seek improvement. The intent of the measure is to annually develop a list of key process improvements. The list will be prioritized based on the estimated effectiveness of the improvement and the completion of the two key process improvements would be tracked in the Performance Plan. The number of key processes, two, was chosen as a starting figure and as experience is gained, that metric may be revised.

The third measure addresses efficiency and effectiveness of our license renewal process which is a major agency initiative. The NRC will continue to gain experience and seek efficiencies where possible to improve on future schedules. An understanding that there will be no major change in our understanding of issues affecting reactor safety and no unexpected significant increase in workload is inherent in these measures (See Major External Factors).

By reducing unnecessary regulatory burden, both the NRC and licensee resources may be made available to more effectively focus on safety issues. Unnecessary regulatory burden for NRC licensees may be defined as requirements that go beyond what is necessary and sufficient for providing reasonable assurance that public health and safety, the environment, and the common defense and security will be protected. For example, recent risk-informed initiatives for inspection and testing (ISI and IST) have allowed the licensees to focus resources more directly on the high risk significant systems and components, and reduce the attention on low risk-significant systems and components thereby contributing to safety and improving effectiveness. The costs associated with NRC activities can impact a variety of NRC stakeholders. This performance goal supports the NRC mission of ensuring adequate protection of public health and safety and the environment in the use of nuclear reactors. In working toward this goal, the NRC will apply its Principles of Good Regulation for being an independent, open, efficient, clear, and reliable regulator.

During the past 30 years, an ever- increasing body of technical knowledge and operational experience has been accumulated, both domestic and international, that allows for refinements and enhancements in NRC requirements and programs that can reduce unnecessary regulatory burden, while assuring maintenance of safety. The NRC believes that for some areas of NRC regulations and practices, the burden is not commensurate with the safety benefit. Not all of our requirements and programs have been updated to take into account these advancements, and thus they may not be as efficient and effective as possible. Reduction in unnecessary regulatory burden may contribute to the NRC effectiveness and efficiency by allowing more focus on safety and risk-significant issues. For example, the new reactor oversight process is allowing more effective staff focus on safety significant issues related to licensee performance.

Although regulation, by its nature, is a burden, we will impose on licensees only the necessary level of burden required to maintain safety. While our current performance goal is to reduce unnecessary regulatory burden, our long-range plans are to eliminate unnecessary regulatory burden to the extent feasible and cost-effective. We will pursue risk-informed and performance-based approaches, if justified, so that we can focus our attention on those areas of highest safety priority. We will make more realistic decisions through reducing excessive conservatism. The ever increasing body of domestic and international technical knowledge and operational experience will be used to refine and enhance NRC requirements and programs.

Strategies

The NRC will employ the following strategies to reduce unnecessary regulatory burden on stakeholders:

• We will utilize risk information and performance-based approaches to reduce unnecessary regulatory burden.

As part of our agency-wide Risk-Informed Regulation Implementation Plan (FY 2001), we will modify or delete regulations that provide little or no safety benefit. We will focus on less prescriptive and more risk- informed and performance- based regulatory approaches to provide licensees with flexibility in meeting regulatory requirements. The scope and priority of changes in our regulatory processes will consider lessons learned from the revised reactor oversight program, stakeholder initiatives, international experience, and the cumulative effect on agency and licensee burden reduction.

• We will improve and execute our programs and processes in ways that reduce unnecessary costs to our stakeholders.

As we execute our programs, we will make improvements to those aspects of our regulatory processes that have resulted in unnecessary regulatory burden to our stakeholders. In particular, we will evaluate the timeliness of actions and the necessity for multiple rounds of requests for additional information. As we make licensing decisions, conduct inspections, and take enforcement actions, we will consider the necessity of any additional burden imposed on licensees.

• We will improve our reactor oversight program by redirecting resources from those areas less important to safety.

We are implementing a revised reactor oversight program that focuses NRC inspection resources on licensees with performance problems, reduces regulatory attention on licensees that perform well, evaluates violations of regulations in a predictable and consistent manner that reflects the safety impact of the violations, and provides the nuclear industry and public with timely, objective, and understandable assessments of plant performance.

• We will actively seek stakeholder input to identify opportunities for reducing unnecessary regulatory burden.

We will encourage stakeholders to identify concerns with the NRC's regulatory programs, such as untimely, inadequate, or inappropriate staff actions, that have resulted in unnecessary cost. In addition, we will continue initiatives to interact with stakeholders to ensure a mutual understanding of existing regulatory requirements, guidance, or licensing decisions. Such interactions will provide opportunities for stakeholders and international regulatory bodies to identify problems and suggest improvements. The NRC will also be able to clarify or explain the basis for requirements, guidance, or licensing decisions, and why we believe they are necessary and sufficient. Where guidance is being developed or used for the first time, we will invite stakeholder feedback to identify aspects of the guidance that might be unclear, unnecessary, inflexible, or otherwise considered excessively burdensome. Where licensees are using new requirements or guidance for the first time, we will interact with them upon request to resolve implementation questions or technical issues.

Measures

We will use the following measure to assess our results in reducing unnecessary regulatory burden on stakeholders:

• Complete those specific milestones to reduce unnecessary regulatory burden as identified in the annual Performance Plan.

The objective of the forthcoming burden reduction plan (to be completed by FY 2001) is to develop and implement a process for collecting data for identifying activities that have the greatest impact on reducing unnecessary regulatory burden while maintaining safety. The agency is currently developing milestones for reducing unnecessary burden while maintaining safety and has not yet identified the specific milestones to be completed during the years covered by this Strategic Plan. Specific milestones will be identified each year in the NRC's Annual Performance Plan. The NRC will be developing criteria for the choice of the specific milestones and for the monitoring processes. Milestones for the development and implementation of these criteria and the monitoring process will be included in the Annual Performance Plan, so that progress on this activity will be reported to Congress on an annual basis.

STATUTORY AUTHORITY

- Atomic Energy Act as amended

- Energy Reorganization Act as amended

- National Environmental Policy Act

- National Historic Preservation Act

- Endangered Species Act

- Clean Water Act

- Clean Air Act as amended

- Nuclear Non-Proliferation Act

- Energy Policy Act

MAJOR EXTERNAL FACTORS

We have identified several external factors that could significantly affect achievement of our Strategic or Performance Goals. However, as maintaining safety is our preeminent performance goal, we will devote and reprogram sufficient resources to maintain safety at the expense of the other performance goals. The following key assumptions have been made regarding the external factors:

• There are no nuclear reactor accidents.

Based on the improved safety performance of the nuclear industry, we believe the probability of a nuclear reactor accident is very low and will remain at this level. Furthermore, we believe that the threat of terrorism has not changed and therefore the probability of sabotage initiating an accident at a nuclear power reactor will remain unchanged. The safe use of nuclear reactors is the responsibility of NRC licensees and regulatory oversight of licensees is the responsibility of the NRC. Therefore, we are not in direct control of this external factor. A nuclear reactor accident could affect our strategic goals through the potential for deaths, illnesses, or releases of radioactive material to the environment. In addition, an accident would impact our performance goals in that safety was not maintained and public confidence in the NRC pursuing its mission would wane. As a result, resources devoted to our other performance goals (e.g., increasing effectiveness, efficiency, and realism, and reducing unnecessary regulatory burden) would be redirected to evaluate NRC programs to determine the needed improvements in safety.

• There are no significant adverse trends in the safety performance of nuclear reactors.

Over the past ten years, the safety performance of the collective nuclear industry has greatly improved. We believe this safety performance will remain stable, if not continue to improve. This, in part, has allowed the NRC to transition to a revised reactor oversight program for its inspection, assessment, and enforcement activities that is more risk-informed and performance-based. Beyond the baseline inspection program that all nuclear reactors will receive, additional NRC resources will be directed to those licensees with performance problems. Through the revised reactor oversight program, we anticipate that adverse trends in the safety performance of nuclear reactors will be identified prior to becoming significant. Although not directly affecting our strategic goal, if significant adverse trends occur, our performance goals of maintaining safety and increasing public confidence may not be achieved. As a result, we would redirect resources to further assuring maintenance of safety, while continuing to develop and improve the revised reactor oversight program to meet our safety needs. This redirection would impact our ability to meet our other performance goals of increasing effectiveness, efficiency, and realism, and reducing unnecessary regulatory burden.

• Economic deregulation and restructuring of the electric power industry will continue.

The pace of the deregulation of the electric power industry will increase and there is potential for considerable change in the nuclear power industry. Although we do not believe economic deregulation will affect our strategic goals, the effect of deregulation on maintaining nuclear safety is unclear. Deregulation could result in improvements to safety through standardization of best practices, maintenance of the status quo, or degradation of safety through excessive efforts to reduce costs. We will continue to rely upon our inspection, assessment, and enforcement programs as the primary tool for evaluating and ensuring safe operations at our licensed facilities. The potential impact of deregulation on our other performance goals of increasing public confidence, increasing effectiveness, efficiency, and realism, and reducing unnecessary regulatory burden is also unclear. The general public may have increased concerns about the safety of nuclear power plants in a more cost-competitive environment, thereby affecting our efforts to increase public confidence. On the other hand, to remain cost-competitive, licensees put pressure on the NRC to accelerate reform efforts to increase efficiency and effectiveness and reduce unnecessary regulatory burden. Large conglomerates may emerge from consolidation of the nuclear power industry and may necessitate changes in our management and organizational structure to effectively and efficiently regulate the industry. Our corporate management strategies discuss our strategy for modifying our management and organizational structure from such external factors as economic deregulation and restructuring of the electric power industry.

• The public and other stakeholders will continue to provide substantial feedback and interact with the NRC to improve our regulatory programs and processes.

Public and other stakeholder feedback and interaction are vital elements of the identification and implementation of needed improvements to our regulatory programs and processes. The NRC has historically focused its efforts and resulting regulations, programs, and processes with reactor safety as essentially the sole goal. However, over the past several years, we have aggressively pursued feedback from the public and other stakeholders on methods by which we can maintain safety, while increasing public confidence, reducing unnecessary regulatory burden, and making NRC activities and decisions more effective, efficient, and realistic. Without the public's and other stakeholders' continued substantial participation in these efforts, we may not achieve our performance goals relating to public confidence, unnecessary burden reduction, and effectiveness, efficiency, and realism. Substantial interaction with the public and other stakeholders is vital to identifying those programs and processes that should be improved on a priority basis, providing recommendations on alternatives, and reporting results of these evaluations. Through continued public and other stakeholder interactions, we can leverage our efforts to meet our performance goals.

• There is no major change in our understanding of issues affecting reactor safety, no major change in our understanding of the threat of terrorism, and no unexpected significant increase in workload from activities such as an application for a new nuclear power reactor or an early site permit.

These factors reflect our view that we are sufficiently knowledgeable about nuclear reactor safety and safeguards issues. Although these factors would not affect our Strategic Goals, they could impact our ability to fully meet our performance goals relating to public confidence, unnecessary burden reduction, and effectiveness, efficiency, and realism. A change in our understanding of reactor safety issues could result in resources being reprogrammed to efforts to maintain safety.

• While there will be sufficient nuclear energy-related skills, experimental facilities, or other resources to accomplish our goals in the near future, there is likely to be a longer term shortfall in these areas.

The lack of nuclear energy-related skills, experimental facilities, or other resources could affect our ability to achieve improvements in our regulations and supporting programs and processes needed to reduce unnecessary burden to increase effectiveness, efficiency, and realism, and to ensure the safety of new technologies. Recent studies indicate that the availability of expertise and facilities will lag demand. The expected increase in the pace of introduction of new technologies (i.e., introduction of digital instrumentation and controls system to replace the existing analog systems at nuclear power plants) will challenge our existing expertise and necessitate increased attention in this area.

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Nuclear Materials Safety

The Nuclear Materials Safety arena encompasses regulatory activities associated with uranium recovery, nuclear fuel cycle facilities, and nuclear materials users. It includes 26 operating uranium recovery sites, 21 uranium recovery sites under decommissioning, 10 major fuel cycle facilities and several other smaller licensed facilities, and more than 20,000 specific materials licensees regulated by either the NRC or Agreement States.⁽¹⁵⁾ In addition, there are estimated to be 100,000 general licensees within the arena. This diverse regulated community includes uranium extraction; uranium conversion; uranium enrichment; nuclear fuel fabrication; fuel research and pilot facilities; and large and small users of nuclear material for industrial, medical, or academic purposes. The latter group includes radiographers, hospitals, private physicians, nuclear gauge users, large and small universities, and others.

This strategic goal represents the principal focus of the Nuclear Materials Safety arena. The goal is to achieve our mission and fulfill our statutory requirements as stated above. For fuel cycle activities, the NRC is the primary regulatory body. For materials activities, the NRC currently shares its regulatory authority with 32 Agreement States throughout the country. As well, uranium recovery activities function under concurrent jurisdiction between NRC and the Environmental Protection Agency (EPA). The NRC Regions also play an important role in inspecting NRC licensees, reacting to events, and licensing material activities. Throughout the arena, it is recognized that licensees⁽¹⁾ and other stakeholders are key participants in the collective efforts that will be necessary to achieve program success. We also recognize and will use domestic and international research, technical studies, operating experience, and risk information to ensure that the regulatory framework⁽¹⁶⁾ is based on technically sound and realistic information.

Measures

We will use the following measures to assess results in achieving the Nuclear Materials Safety strategic goal. To the extent applicable, measures include the NRC and Agreement States licensee events. With respect to the second measure and metric, the NRC and Agreement States' licensees have reported a small number of such exposures nearly every year for which reporting was required. Each exposure is a cause of concern, prompting us to analyze its root cause and to determine appropriate follow-up actions. We will always strive to prevent such events from occurring, but it is possible that a few such events will occur. The NRC and Agreement States regulate more than 20,000 materials licensees who conduct millions of medical procedures annually and thousands of industrial processes for nuclear materials daily. Failure to meet this metric, or any of the others, would trigger a self-assessment of the NRC's materials arena activities to determine if changes are needed.

The measures⁽²⁾ are as follows:

• No deaths resulting from acute radiation exposures from civilian uses of source, byproduct, or special nuclear materials, or deaths from other hazardous materials used or produced from licensed material.

• No more than six events per year resulting in significant radiation or hazardous material exposures⁽¹⁷⁾ from the loss or use of source, byproduct, and special nuclear materials.

• No events resulting in releases of radioactive material resulting from civilian uses of source, byproduct, or special nuclear materials that cause an adverse impact on the environment⁽⁵⁾

• No losses, thefts, or diversion of formula quantities of strategic special nuclear material; radiological sabotages; or unauthorized enrichment of special nuclear material regulated by the NRC.⁽¹⁸⁾

• No unauthorized disclosures or compromises of classified information causing damage to national security.⁽¹⁹⁾

The Commission recognizes that activities associated with the use and disposal of nuclear materials could pose risks to the public. Given the risk inherent in these activities, the first two measures are being used as indications of whether we are achieving the strategic goal of preventing radiation-related deaths or illnesses.

These measures identify events that would result in significant adverse impacts on public health and safety, the national security, or the environment. They include events from the NRC and Agreement States. They relate to events associated with regulated activities that must be reported accurately by licensees to the NRC and Agreement States in accordance with NRC regulations. These could result from NRC licensee fuel cycle safety and safeguards program activities, or from activities of the NRC or Agreement State licensees related to the use of nuclear materials for medical, academic, or industrial purposes. Sometimes events are difficult to quantify because some events require medical estimates of the probability of functional damage to an organ developing in later years. Any occurrence would trigger a self-assessment of the NRC's Nuclear Materials Safety activities to determine if changes are needed.

The NRC will continue to protect the public, workers, and the environment and ensure that licensed and authorized activities will not be inimical to the common defense and security. This protection will be accomplished by ensuring that regulated materials^(14),(20)activities are undertaken consistent with applicable statutes and regulations. In so doing, the NRC will continue to provide reasonable assurance that adverse impacts from licensees' use of byproduct, source, and special nuclear material will be prevented. This protection also entails maintaining a high assurance against loss, theft, diversion, or unauthorized enrichment of nuclear material; sabotage of nuclear facilities; and disclosure of classified information.

This is the NRC's preeminent performance goal, which has a higher priority than the other Nuclear Material Safety performance goals. In working toward this goal, the NRC will apply its Principles of Good Regulation. Principles applicable to this goal are related to independence, openness, regulatory clarity, and reliability.

Although the goal is to maintain rather than to increase safety and safeguards, this represents a composite approach for the many categories of licensees represented in this arena. Because of the diversity within and among licensed activities in this arena, and the risks involved in the activities, additional safety improvements in certain areas may be warranted. Most nuclear material facilities and a large majority of materials licensees have operated safely and securely for many years. The industries, the NRC, and the Agreement States have recognized that certain elements of the fuel cycle and materials industries are mature, and practices and standards already in place have been tested over time and found to be acceptable in maintaining safety and security. Even in this climate, regulators must resist any tendency toward complacency. On the other hand, other elements of this arena involve newer technologies and practices. As new technologies and other advances are introduced by applicants or licensees, the NRC will determine, on a case-by-case basis, when early notification of the States is warranted. In both cases, regulators must pursue risk-informed and performance-based⁽⁷⁾ approaches, where justified, to focus attention on those areas of highest safety and security priority. We will ensure that our decisions are scientifically-based; risk-informed; and shaped by operational experience, new information, and research, from domestic and cooperative international activities. Furthermore, protecting future generations is an aspect pertaining to uranium recovery site remediation. This protection is accomplished through maintaining requirements for such protection in our regulations and authorizing licensee activities only after determining that proposed activities will protect both current and future generations. This approach is embodied in the first and second strategies for this arena.

For our uranium recovery activities, most of the work supporting the safety oversight of DOE's remedial actions to clean up inactive mill sites is completed. Thus, the program's focus will be on controlling the radiological and non-radiological hazards of mill tailings sites and assuring the safe operation of uranium extraction facilities.

The arena also recognizes the NRC's shared regulatory responsibility with the 32 Agreement States. The NRC has to ensure that the State programs are adequate and compatible with its own regulatory programs to attain a uniform nuclear safety policy throughout the Nation. This uniformity will take on increased significance as more States assume regulatory authority for materials safety over the next several years. In recognition of the important contributions of the Agreement States toward maintaining safety, the NRC will encourage States to pursue a more active role in the implementation of strategies that contribute to the safety performance goal. The NRC and Agreement States will take decisive action to improve the safety performance of licensees identified as operating below acceptable levels for ensuring public health and protection from undue hazards.

Finally, this goal recognizes the NRC's mandate to promote the common defense and security. The NRC's safeguards, physical protection, and threat assessment activities all combine to provide high assurance that commercial activities involving special nuclear material (SNM) are not inimical to this purpose and do not constitute an unreasonable risk to public health and safety. The NRC's threat assessment function contributes to national and international programs designed to identify and limit the risk of proliferation of weapons of mass destruction and weapons-usable materials and threats posed by terrorists, criminals, and foreign regimes determined to commit hostile acts against NRC-regulated facilities and activities. Our safeguards system monitors and ensures that NRC licensees maintain nuclear material protection, control, and accountability, and our physical protection component represents the principal barrier for those who would attempt to sabotage, steal, or divert SNM. Such an important function has continued to be an effective deterrent against these threats, but our activities will take on increased priority as the availability of weapons-usable material and the information technology to build nuclear explosives continues to become more widespread, and the increasing vulnerabilities to cyber-terrorism continue as systems become more automated.

Strategies

The NRC will employ the following strategies to maintain safety, protection of the environment and promote the common defense and security:

• We will continue to improve the regulatory framework to increase our focus on safety and safeguards, including incremental use of risk-informed⁽⁷⁾ and, where appropriate, less prescriptive performance-based⁽⁷⁾ regulatory approaches to maintain safety.

In the materials arena programs, the regulatory framework continues to evolve, even though many parts of the fuel cycle and nuclear materials industries are in a mature state. The regulations contain some prescriptive requirements, where necessary, while other sections of the regulations are more performance-based. As appropriate for the individual Nuclear Materials arena programs, risk-informed and performance-based approaches will be incorporated incrementally to improve the focus on safety of the regulations and related guidance making up the regulatory framework. We will ensure, by using risk assessment techniques for differentiating between high- and low-risk activities, that our regulatory focus is on those activities that pose the greatest risk to the public. We are continuing to focus on those areas where important gaps in information are present and where uncertainties exist about the significance to risk. We are developing guidance to ensure that specific applications of risk assessment methods are suitable and that there is consistency in their use in our decision-making process. Because of the diversity of programs within the Nuclear Materials Safety arena, risk assessment techniques will be used only where the subject matter is amenable to the risk assessment strategy and where the greatest benefit could be derived.

For programs where new technology is involved or where regulations or guidance are new or evolving, interactions with potential applicants will be important to discuss acceptable ways to comply with regulatory requirements. More prescriptive requirements may be appropriate for some new technologies.

Finally, we will evaluate potential new information from our domestic and cooperative international research programs as well as from our participation in international committees and workshops, new safety issues, changing external factors, and licensee operational experience so that improvements can be made to maintain an adequate regulatory framework. In this regard, we will be quick to share relevant generic safety information (e.g., Bulletins, Information Notices) with Agreement States and licensees so we can learn from each other's experiences. Related guidance will be updated periodically, taking into account risk information, whenever possible, and allowing flexibility for licensees to develop performance-based solutions, when these solutions are shown to be acceptable from a safety and safeguards perspective. For medical uses, the NRC and the Food and Drug Administration share information of mutual interest related to the approval of medical devices, radioactive drugs, and radioactive biologics when these products contain NRC-regulated material.

• We will continue authorizing licensee activities only after determining that these proposed activities will be conducted consistent with the regulatory framework.

In the Nuclear Materials Safety arena, the NRC issues several hundred new licenses each year and terminates about the same number. The NRC approves more than 3,000 amendment requests and makes decisions on license renewals as the licenses approach their expiration dates. Some of these actions are fairly routine in nature, and these decisions can be reached in a relatively short period of time. Conversely, some major materials licensees, including the fuel facilities, engage in more complex operations. Therefore, the decisions associated with these licenses require a more rigorous review of licensee personnel qualifications, safety and safeguards programs, systems, and facilities. On some occasions, these evaluations include safety, safeguards, or environmental reviews; issue resolution; and documentation of the technical bases and findings in publicly available safety and safeguards evaluation reports and either environmental assessments or environmental impact statements.

Licensing submittals and approvals are often made easier when licensees and reviewers use available guidance documents. These documents are not intended to supplant regulatory requirements. They are intended to serve as tools to assist licensees and license reviewers in their understanding of the license application and review process. Therefore, they will be updated at regular intervals to maintain currency. Regulations will be applied to independently evaluate the licensees' demonstrations that proposed activities comply with regulations. While conducting these evaluations, we will employ risk-informed methods and data, where appropriate. In addition, the adjudicatory hearing process will support final licensing decisions. Technical assistance will be provided to the Agreement States, when requested, to help them in conducting their reviews.

• We will confirm that licensees understand and carry out their primary responsibility for conducting activities consistent with the regulatory framework.

For fuel cycle and materials licensees, investigations, inspections, or other independent approaches (e.g., third-party reviews) will continue to be important methods to verify that licensees understand their responsibility for safety and that their activities remain in compliance with regulatory requirements. Inspections must identify any safety and safeguards issues and resolve them before they affect safe and secure operations. We will use the risk-informed regulatory framework to inspect licensees at varying frequencies and with varying techniques, depending on the relative risks of the activities. Increased attention will be given to licensees with marginal performance, by focusing inspection resources on the basis of licensee performance. Finally, we will share relevant generic safety information (e.g., Bulletins, Information Notices) with Agreement States, licensees, and other involved federal agencies so we can learn from each other's experiences. Allegations regarding licensee or Agreement State performance will be appropriately and objectively addressed in a timely, systematic manner. Allegations of potential wrongdoing will be appropriately and objectively investigated in a timely manner. Enforcement sanctions for violations of regulatory requirements will be commensurate with the safety significance.

• We will respond to operational events involving potential safety or safeguards consequences.

We will provide timely, accurate, and complete assessments of safety and safeguard events by evaluating licensees' recommendations for actions to protect the public or national defense and security and by coordinating with other Federal agencies, State and local governments, international entities, and the licensee. In the event of an emergency involving an NRC-regulated entity, this would include working closely with one or more of the following agencies: FEMA, DOE, EPA, USDA, HHS, NOAA. The technical staff will have sufficient skills and knowledge to support the agency or State in responding to operational events. Additional support will be provided by the continuously staffed Incident Response Operations Center. Periodic exercises will be conducted to ensure that response organizations are proficient and experienced and that staff are trained to respond to operational events according to their safety or safeguards significance. Incident investigation capabilities also will be maintained.

• We will maintain safety by continuing to evolve along with Agreement States materials program into a single "National Materials Program" by encouraging the States to continue to pursue a more active role in the regulatory process.

Safety is a shared responsibility among the NRC, the Agreement States, and licensees. A total of 32 States regulate more than 15,000 specific radioactive materials licenses, as compared to 5,300 regulated by the NRC. Several other States are working towards becoming Agreement States in the next few years. This trend will continue to shift more of the licensees from the NRC to the States, and will require more cooperation and coordination between the NRC and the States to ensure safe licensee activities throughout the country. To this end, the Commission

recently approved the formation of a working group to coordinate with the Conference of Radiation Control Program Directors to address the impacts of this trend and to provide advice to the Commission. Defining and implementing future NRC and State roles under a national strategy and infrastructure for regulating materials licenses in this new environment will help ensure a more consistent and effective national focus on safe licensee performance for all of the 20,000 specific materials licensees throughout the country.

We will continue to conduct Integrated Materials Performance Evaluation Program (IMPEP) reviews to verify the adequacy and compatibility of Agreement State materials programs and the technical quality and consistency of the NRC's materials program licensing and inspection activities. The process is also designed to identify performance strengths and weaknesses.

Over the past several years, increased cooperation between the NRC and the Agreement States has helped identify solutions to common program issues. The NRC will encourage the States to continue to take on a larger share of program responsibilities in the future.

Measures

The NRC will use measures to assess results in our effort to maintain safety and protect the environment and to promote the common defense and security. These include events involving the NRC and Agreement States. Many of the events that are counted in these measures do not, on an individual basis, have a public health and safety impact. For example, most of the losses of control of licensed material are of shielded material, unlikely to result in overexposures or releases to the environment. Others are medical events that include underexposures (i.e., radiation treatments involving less radiation than the physician intended). These events are included because they may indicate program weaknesses, which, if ignored, could later trigger a more significant problem. The NRC will use the following measures.⁽²⁾

• No more than 350 losses of control of licensed material per year.⁽²¹⁾

• No occurrences of accidental criticality.

• No more than 20 events per year resulting in radiation overexposures⁽²²⁾ from radioactive material that exceed applicable regulatory limits.

• No more than 45 medical events per year.⁽²³⁾

• No more than 40 releases per year to the environment of radioactive material from operating facilities that exceed the regulatory limits.⁽²⁴⁾

• No non-radiological events that occur during the NRC-regulated operations that cause impacts on the environment that can not be mitigated within applicable regulatory limits, using reasonably available methods.⁽²⁵⁾

• No more than five substantiated cases per year of attempted malevolent use of source, byproduct, or special nuclear material.

• No breakdowns of physical protection or material control and accounting systems resulting in a vulnerability to radiological sabotage, theft, diversion, or unauthorized enrichment of special nuclear material.⁽²⁰⁾

Maintaining nuclear materials safety and safeguards is the primary goal for the various activities in the Nuclear Materials Safety arena. The metrics for these measures would maintain safety performance at about the same level as prior years. The threshold for a reportable event is more stringent for performance goal measures than the strategic goal measures. They provide the opportunity to detect programmatic weaknesses before the strategic goals would be exceeded. However, since target values are numbers of events reported, the targets for strategic goal measures could be exceeded without exceeding performance goal measures which allow a higher number of events. Safety measures will include data from the NRC and Agreement State licensees, where appropriate.

This arena involves a range of activities that, during the course of normal day-to-day operations, places radioactive material in medical or industrial settings that provide more opportunities than other arenas for overexposures, medical events, and/or releases to occur. In the medical field alone, several million procedures take place each year that involve radioactive material used to diagnose or treat diseases. While the NRC and Agreement States continue to support a regulatory philosophy that places safety as the pre-eminent consideration, this plan acknowledges that the above numbers represent the most realistic set of metrics, based on available performance data. The metrics include some events of limited safety significance, such as a number of lost portable moisture density gauges, tracked under measure 1, even though few such events have resulted in overexposures. These events are included, since they could be indicators of potential weaknesses that could later result in a failure to achieve the strategic goals in this arena.

In addition, the sixth measure is limited to non-radiological environmental impacts from operations, including remediation, of uranium recovery and fuel cycle facilities regulated by the NRC. For uranium recovery facilities, under the Uranium Mill Tailings Radiation Control Act, the NRC regulates releases of certain non-radiological hazardous constituents to the environment in addition to radiological releases. Therefore, for these facilities, examples of events include non-radiological releases to the environment (e.g., to groundwater and surface water) resulting from excursions at in situ leach facilities and leaks from tailings cells at conventional uranium mills.

The NRC views building and maintaining public trust and confidence that the NRC is carrying out its mission as an important performance goal for the agency. To reach this goal, the NRC must be viewed as an independent, open, efficient, clear and reliable regulator. This will be accomplished by providing our stakeholders with clear and accurate information about, and a meaningful role, in our regulatory programs. The NRC desires that diverse stakeholder groups (i.e., general public, Congress, NRC licensees, other Federal agencies, States, Indian Tribes, local governments, industry, industry workers, technical societies, the international community, and citizen groups) increasingly recognize that NRC actions assure that public health and safety, the common defense and security, and the environment are, and will remain, adequately protected from hazards resulting from the use of nuclear materials.

The NRC must continue to forthrightly inform the public about nuclear safety and safeguards incidents and issues and provide avenues for meaningful input and dialogue. However, discussing in a public forum issues involving nuclear security or related to national defense is not usually prudent. Because of the diversity of stakeholder and public interests within this arena, the goal includes recognition that the NRC may not always be able to obtain a consensus among its stakeholders. This goal also includes recognition that, although the public may not always agree with the NRC's actions, public confidence in the NRC is enhanced when the agency listens to all interested parties, provides appropriate feedback, and makes its decisions in a thorough, disciplined, and timely manner.

Although the NRC has conducted its regulatory oversight openly and has provided information to a variety of stakeholders, it recognizes the need for continued improvement, especially with respect to future regulatory changes and interactions with Agreement States. This means that continued dialogue between the NRC and the Agreement States is required to develop solutions to common problems. The NRC recently completed a variety of initiatives to better inform stakeholders and to obtain their input on significant issues. Based on the initial efforts, the NRC's goal is to expand efforts and achieve greater improvement in this area. This may include more public meetings and more workshops with important sectors of the regulated community. The NRC will increase its efforts for public outreach through an integrated communications plan to implement strategies to effectively communicate with and involve the diverse stakeholders early in regulatory activities.

Strategies

The NRC will employ the following strategies to increase public confidence:

• We will make public participation in the regulatory process more accessible. We will listen to their concerns and involve them more fully in the regulatory process.

One of the attributes of strong and fair regulation in the materials arena involves consistent and early public involvement. The agency recognizes the public interest and concern in the proper regulation of materials arena activities. The agency further recognizes its responsibility to provide opportunities for meaningful public interaction and involvement. The NRC will listen to, and be responsive to, requests, inquiries, and concerns from the public. We will provide opportunities for stakeholders to bring information and issues to the NRC by holding open meetings in the vicinity of those affected, providing adequate notice of meetings, developing and implementing communications plans for major regulatory activities, and holding workshops. We will consistently consider this input in planning changes and making decisions relating to our practices, rules, and processes.

• We will communicate more clearly. We will add more focus, clarity, and consistency to our message, be timely, and present candid and factual information in the proper context with respect to the risk of the activity.

Public confidence in the NRC will be enhanced by avoiding raising stakeholder concerns unnecessarily. We can avoid concerns if the information is presented in a manner that is easily understood and

placed in its proper safety context. Whenever possible, we will use quick, personalized forms of contact with stakeholders. Communications with the public will be designed to foster greater understanding of, and confidence in, our regulatory program. The information we disseminate will be clear, technically sound, accurate, reliable, objective, and timely. We will take full advantage of the Internet and new technology for information dissemination. We will protect the private, proprietary, and classified nature of information. All stakeholders should be able to rely on our statements and information as being objective and not promotional. The NRC will clearly communicate to and educate stakeholders about its precise role in the materials arena.

• We will continue to enhance the NRC's accountability and credibility by being a well-managed, independent regulatory agency. We will increase efforts to share our accomplishments with the public.

We will explore additional opportunities to convey our actions and activities, including achievements, to a broader audience. This may include expanding our reports to Congress, increasing our information exchange with the media outlets, and enhancing our external and internal home pages.

• We will continue to foster an environment in which safety issues can be openly identified without fear of retribution.

Public confidence is enhanced in an environment where safety and security issues can be raised and addressed without fear of retribution. Examples of how this strategy will be implemented in this arena include conducting the NRC's 10 CFR 2.206 petition process, responding to allegations, addressing safety-conscious work environment concerns, and implementing the NRC's programs for differing professional views/opinions. We will also participate in the agency's pilot program to solicit feedback from individuals raising safety or security issues to assess the NRC's effectiveness in handling allegations. Finally, we will encourage licensees and applicants to be open and responsive to the public affected by their regulated actions.

Measures

The NRC will use the following measures to assess the results in our efforts to increase public confidence:

• Complete the milestones in the annual Performance Plan relating to collecting, analyzing, and trending information for measuring public confidence.

• Complete all of the public outreaches as scheduled in the annual Performance Plan.

• Complete the milestones specific to the agency allegation program effectiveness assessment plan as identified in the annual Performance Plan.

• Issue Director's Decisions for petitions filed to modify, suspend, or revoke a license under 10 CFR 2.20612 within an average of 120 days.⁽¹³⁾

The staff is increasing the number, and improving the quality, of its interactions with external stakeholders. We intend to take advantage of these interactions by requesting feedback from the stakeholders that participate in them. The staff believes that the combination of (1) being more pro-active in interacting with external stakeholders, (2) improving our interactions with these stakeholders, (3) improving our responsiveness to stakeholder concerns, and (4) systematically monitoring feedback will allow the staff to assess changes and trends in public confidence.

Public outreach was chosen as a performance measure for public confidence based upon NRC experience from well conducted public outreaches. In response, the need for communication plans is recognized in this Strategic Plan and will be completed in FY 2000. The annual Performance Plan will identify the specific metrics that will be used in assessing results.

The agency is currently developing an agency allegation program effectiveness plan (to be completed by FY 2002) and has not yet identified the specific milestones for the years covered by this Strategic Plan. Specific milestones will be identified each year in the NRC's Annual Performance Plan. NRC will be developing criteria for the choice of the specific milestones and for the monitoring processes. Milestones for the development and implementation of these criteria and the monitoring process will be included in the Annual Performance Plan, so that progress on this activity will be reported to Congress on an annual basis.

The assumption that the public and other stakeholders will continue to provide substantial feedback to and interact with the NRC to improve our programs and processes is inherent in the above strategies and measures.

The NRC will continue to improve its regulatory processes so that they become more effective, efficient, and realistic. The NRC and the Organization of Agreement States will identify and focus on necessary and sufficient regulatory activities that are linked to its goals. In those regulatory activities, the NRC will strive to optimize regulatory programs and processes, where possible, while assuring safety and security and improving public confidence. In working toward this performance goal, the NRC will apply its Principles of Good Regulation, which include efficiency, clarity, and reliability.

The NRC will ensure its decisions are scientifically-based, risk-informed, and shaped by operational experience, new information, and research, including cooperative international activities. As a result, the NRC's decisions will be realistic, will be systematic, and will appropriately treat areas of uncertainty. The NRC will ensure that its procedures, processes, and expectations are better-defined, clearer, and more transparent. The NRC's regulatory actions will support more consistent, reliable, predictable, and timely decision-making. Furthermore, the NRC will seek to minimize duplication of efforts with stakeholders to achieve this goal, while relying on the technical and managerial competence of its staff to achieve success.

By striving to become more effective, efficient, and realistic while continuing to assure adequate protection of the public health and safety and the common defense and security, the NRC intends to keep regulatory burden and related costs to licensees and applicants as low as practical. The NRC will capitalize on advances in technology and implement changes to improve internal processes related to regulatory actions. As part of this effort, the NRC will continue its efforts to develop and update licensing and inspection guidance in order to improve the consistent, effective, and efficient implementation of its policies in the field. Furthermore, the NRC will strive to be less prescriptive and will apply risk-informed, performance-based approaches where it is appropriate to do so.

Effectiveness means producing the necessary and sufficient work to achieve our goals. The NRC must periodically challenge the value of its programs and activities based on how they contribute to the achievement of goals. The NRC business processes and regulatory decisions will reflect high standards of quality and be technically sound. Specific challenges in this regard involve: (1) risk- informing the NRC's regulatory programs, (2) preparing to address evolving technologies and a changing regulatory environment, and (3) improving the predictability and consistency of agency decisions. We will also pursue international cooperative research in order to leverage our research resources, share research facilities wherever possible, and maintain our involvement in international committees and working groups that can best further our interests and minimize unnecessary duplication of effort.

Efficiency means conducting work productively and on time. Efficiency will be enhanced by simplifying or streamlining our internal processes based on self-assessment and experience, using improved tools, and becoming more timely and predictable in delivery of services and decisions.

To become more effective and efficient, the NRC will plan and schedule its work activities and identify key milestones to monitor progress. When issues emerge, the NRC will readjust plans, schedules, and resource allocations, if necessary, to ensure that attention is focused on the highest priority activities so they are conducted efficiently. The NRC decisions will be made more realistic by eliminating excessive conservatism. Realism is supported by risk information, research results, and operational experience.

Strategies

The NRC will employ the following strategies to make NRC activities and decisions more effective, efficient, and realistic:

• We will continue to improve the regulatory framework to increase our effectiveness, efficiency, and realism.

We will make improvements to our regulatory framework or take other agency actions (e.g., seek legislative changes) to resolve circumstances that reduce our effectiveness or efficiency. For example, improvements would be needed for circumstances such as: (1) overlapping regulatory responsibility or dual regulation, (2) conflicting positions regarding regulatory jurisdiction, and (3) conflicting standards that impact finality of licensing decisions. Furthermore, we will incorporate risk-informed and performance-based approaches, as appropriate, into our regulatory framework when they can substantially improve our effectiveness, efficiency, and realism (i.e., reduce excessive conservatism). This will be accomplished, in part, by conducting an integrated evaluation of risk information, inspection findings, operating experience, research results, and cost data as part of the agency-wide Risk-Informed Regulation Implementation Plan (to be completed by FY 2001). In addition, we will continue to incorporate, where applicable, existing consensus standards into our regulatory framework. We will also encourage stakeholders to develop and use new consensus standards.

Furthermore, we will develop and revise appropriate licensing and inspection guidance so that applicants and staff have a clear and consistent understanding to develop and review licensing applications, respectively. This guidance should minimize the staff's requests for additional information, subsequent license revisions, and additional rounds of staff review. It will also help the staff prepare for and conduct inspections.

Finally, we will anticipate, through research, participation in international committees and workshops, and technical studies, opportunities for regulatory improvements that may come from industry's introduction of new technologies. Similarly, we will use domestic and international research, technical studies, and risk information to reduce excessive conservatism and ensure that the regulatory framework is based on technically sound and realistic information. In addition, to improve decision-making, we will develop processes that will assess the skills and tools needed by the staff to allow the appropriate level of decision-making for specific types of decisions consistent with our statutory and regulatory authority. Staff will be authorized to take the appropriate and necessary action and make decisions that are within the scope of their assigned responsibilities and will be accountable for those actions and decisions.

• We will identify, prioritize, and modify processes based on effectiveness reviews to maximize opportunities to improve those processes.

We will continually improve and standardize our processes through a robust program of self-assessment and application of lessons learned. In particular, effectiveness reviews of program and program support areas will be conducted to determine what work needs to be added, maintained, reduced, or eliminated to deliver the desired outcomes. Efficiency reviews of key processes in program and program support areas will be conducted to determine the most efficient means of delivering the desired outcomes.

• We will improve efficiency and effectiveness by continuing to evolve along with Agreement States materials programs into a single "National Materials Program" by encouraging the States to continue to pursue a more active role in the regulatory process.

Development of a more national strategy and infrastructure for regulating materials licenses consistently will take on increased emphasis and ultimately will make all parties more efficient and effective regulators, as several other States continue to work toward becoming Agreement States in the next few years.

NRC Headquarters has traditionally led the activities that established and improved the regulatory framework, while the NRC's Regions and Agreement States implemented the programs within this common framework. Over the past several years, increased cooperation between the NRC and the Agreement States has helped identify solutions to common program issues. The NRC will encourage the States to continue to take on a larger share of program responsibilities in the future. Examples include Agreement State participation in the NRC/Agreement State working groups, Agreement State participation in IMPEP and in the Nuclear Materials Events Database, and the assumption of responsibility by the Organization of Agreement States for planning and hosting the annual All Agreement States meeting. This increased interaction will allow the NRC to gain additional insights from the comments and input of Agreement States, individually and collectively, especially when substantive program changes are being considered. The periodic IMPEP lessons learned and good practices reports provide examples so that one regulator can upgrade the effectiveness and efficiency of its program based on findings about another regulator. By expanding the States' participation in various work groups, the NRC and Agree