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A written survey of all licensees soliciting quantitative information regulatory impacts (for example, time commitment of various licensee personnel to inspections and audits); A survey of a selected subset of NRC personnel to determine what NRC's own staff perceptions are of the agency's impacts on licensees.
It has long been my observation that the best organizations have a clear sense of purpose and a clear concept of how to achieve their purpose. I am sure each of us in this room can name organizations which work well. For such organizations, one will almost invariably find that the goals and objectives of the organization are evident, and employees seem to understand their role in achieving the organization's goals. One might, at first blush, think that, for most long standing organizations, the organizational goals and objectives would be very clear. Horever, it is not always an easy matter to identify and articulate a clear set of principles to guide an organization in reaching its goals.
Since I have been at the NRC, I have sensed that, despite our clearly defined statutory mission, the NRC was not all together in how that mission is best to be carried out. There were any number of signals to suggest this:
The time required for licensees to support regulatory inspections and other audits, both because of the number of needed actions and their intensity, takes too much attention from other important activities, to the possible detriment of safety. (Implied in each of these first three items is the concern that the NRC requirements and guidance do not have a clear and consistent risk basis.)
There are too many regulatory initiatives over time, resulting in a ratcheting up of requirements.
There are inconsistencies in requirements from region to region and from inspector to inspector. NRC written and oral communications are sometimes unclear or inconsistent.
Secondly, many criticisms and complaints have been expressed by licensees to me, as well as to the other Commissioners, during our plant visits about various aspects NRC's performance. These comments, about which I'll say more later, related to such fundamental issues as consistency of commission action, clarity of communication, and the nexus between our regulatory requirements and safety. The complaints were too numerous, too consistent, and too widespread throughout the industry to dismiss them as being merely a collection of anomalies.
NRC personnel sometimes lack sufficient qualifications and training.
Thirdly, similar criticisms have been made to NEC senior management by licensees, or discussed during a series of NRCUtility Interface meetings several years ago.
NRC actions, including reviews of licensee submittals and enforcement actions, are frequently untimely. Since the development of the principles was completed before the results of the recent impact surveys were available, we could not explicitly consider the findings of the surveys in formulating the principles. However, now that those findings are available, it is clear that the principles can in fact be related to many of the concerns identified in the study. It would be useful to cite the major elements of the regulatory principles we developed, and tell you something about what they - and will mean - for the NRC. As appropriate, I will note related findings of the regulatory impact surveys, and will discuss what licensees can do to help make the principles effective.
The concerns reached a magnitude requiring action. In fact, over the past year, there have been several NRC initiatives in response to the lack of an agency set of operating principles and the consequent concerns about NRC's performance. Some of these initiatives were oriented toward better understanding and characterizing the nature of licensee concerns, with a view towards finding specific fixes. A parallel effort directly addi:essed the lack of an explicitly stated philosophy by attempting to identify and codify key principles that should guide all NRC activities. These different, but nearly simultaneous, activities were manifestation of the growing recognition within the Commission that NRC had a problem that needed to be addressed.
THE NRC MISSION AND REGULATORY PRINCIPLES
DEVELOPMENT OF THE PRINCIPLES
About a year ago, I approached the other Commissioners with suggestion that we develop a statement of the basic jorinciples we thought were necessary to guide the agency and assure a consistent high-level of regulatory performance. The other Corimissioners concurred with this need. As the first part of our initiative we examined examples of institutional philosophies froin a variety of organizations. INPO's Principles of Professionalism and the similar efforts of number of NRC licensees were among the examples we gathered. Other examples came from outside the nuclear field. In addition, of course, we had the NRC's research philosophy statement which had been developed in response to the National Research Council recommendation.
The statement of principles starts first with an expression of our mission, the scope of our responsibility, and the basic functions we perform to carry out our responsibilities. Since I am sure you are all quite familiar with these points, I will not take the time to repeat them here, but I have included them as a supplement to the written version of this talk, which has been made available to the organizers of this meeting. It then identifies some of the elements that have characterized much of our regulatory approach namely, the historic emphasis on incorporating conservatism in our regulations to counter phenomenological uncertainties and of requiring high levels of reliability, redundancy and diversity in systems design. The statement of principles attempts to clarify the purpose of such requirements, and thereby, to give better guidance on how they are to be applied in the future. Imbedded in the discussion the following two points that I regard critical:
Conservatism remains necessary in light of remaining technical uncertainties, but should be modified appropriately over time as our understanding increases. These modifications can be in either direction.
The principle of defense in depth remains appropriate, but equivalent protection of health and safety may be achieved with different mixes of reliability, redundancy and diversity for different technological options; therefore, different mixes of these characteristics should be permissible under NRC regulation, as long required levels of safety satisfied.
The nexus between technical and managerial excellence and efficiency is clear. What is, perhaps, not so clear is what NRC can do to maintain and improve its competencies. We are still developing ways to achieve this goal, including some innovative internal training and development programs, and some new types of technical positions within the agency. Our salary structure, and ability to attract or reward people by direct financial incentives is, of course, limited, but we must continue to identify other ways to make our environment attractive. Some of the possibilities we are likely to give serious attention to in the future include enhanced training and retraining opportunities; greater encouragement of professional activities including increased involvement in technical society activities and meetings, and greater opportunities to publish; maximum possible use of rotational assignments; use of awards and other forms of recognition where possible; and internal QA/QC programs on our managerial effective
The second component of efficiency the relationship of activities to risk significance is one of the key underlying messages of the regulatory impact surveys. The criticism manifested itself in a number of comments, both direct and indirect. We were told our requirements are not consistent with the degree of risk reduction they receive; the need to be responsive to NRC is often inconsistent with the safety significance of other tasks the licensee would like to accomplish; the multiple inspections required take too much management time from higher safety related needs, and so forth. We clearly need to be more sensitive to risk significance, and we are currently putting into place several programs to reduce the impacts of inspections and to allow NRC and individual licensees to agree on a prioritization of outstanding requirements based in part on their risk significance. You can assist us in this by always assuring that we understand the basis for your positions on priorities, or on the need for certain actions we may propose. While I can't guarantee that doing so will suddenly result in perfect agreement between you and NRC staff, it is certainly more likely that we will modify our positions if you can offer sound technical reasons to support an alternative point of view.
4. The fourth principle is that of clarity. "Regulations should be coherent, logical and practical. There should be a clear between regulations and agency goals and objectives whether explicitly or implicitly stated. Agency positions should be readily understood and easily applied." A frequent criticism of NRC relates to our ability to communicate, both orally and in writing. We have been told of instructions are confusing, inconsistent, or difficult to apply. Many of these criticisms are well founded and I think NRC needs to place more emphasis on the ability to communicate. We need to hire people who are not only good technically, but who can speak and write as well. We need to offer more training in communications skills. We need to review our work better for internal consistency and understandability.
The statement then discusses the roles of NRC and its licensees. This is perhaps the key element on which the rest of the statement hangs, and is, to my knowledge the clearest and most direct statement we have made to date. We note that both NRC and its licensees have important roles in assuring safety, but we emphasize that "safe use of nuclear materials is a primary responsibility of NRC licensees." Further, we identify "strong, vigilant management and a desire to improve performance" as "prerequisites for success, for both regulators and the regulated industry." This statement presents to you, the licensees, a clear mandate to take the lead in assuring safety, to be aggressive and innovative in improving safety, and to be proactive, rather than reactive, in working with NRC. Good regulation is characterized as regulation which encourages licensees to take the lead. Notably, good regulation is further characterized as encouraging sound and effective practices, discouraging unsound practices, and identifying questionable practices. It is not enough for NRC simply to focus on one of these elements. Encouraging good practices without suppressing poor ones would not optimize safety, and vice versa. Finally, the statement identifies five characteristics that good regulation must have in order to create the necessary environment for safety. These are independence, openness, efficiency, clarity, and reliability. Let me discuss each of these briefly. 1. The first principle is independence. "Nothing but the highest possible standards of ethical performance and professionalism should influence regulation. However, independence does not imply isolation. All available facts and opinions must be sought openly from licensees and other interested members of the public. The many and possibly conflicting public interests involved must be considered. Final decisions must be based on objective, unbiased assessments of all informa tion, and must be documented with reasons explicitly stated." The need for independence derives directly from the requirement to assure the integrity of the regulatory process. However, too often, the need for independence has seemed to degenerate into isolation. That is not what was intended, and it certainly is not desirable. We at NRC must maintain the broadest possible communication - with licensees, with the research community, with other knowledgeable groups and individuals. I believe this means NRC staff should talk more to licensees and peer groups, not less, and should participate actively in professional society activities. We must maintain independence not by isolating ourselves, but rather by assuring we have not been selective in seeking information, and by assuring that our decisions are based on our own sound analytical reasoning, and not on opinion or unconfirmed second-hand information or analysis. You can help us do that by providing us with data and analysis to support your assertions, by making information available to on request, and by being open in identifying pros and cons of your positions, uncertainties in your analyses, and other qualifying information. 2. The second principle is openness. "Nuclear regulation is the public's business, and it must be transacted publicly and candidly. The public must be informed about and have the opportunity to participate in the regulatory processes as required by law. Open channels of communication must be maintained with Congress, other government agencies, licensees, and the public, well with the international nuclear community." The meaning of this principle is fairly obvious. We identified it separately because of its statutory importance, and because we want to emphasize the need to comply with both the letter and the spirit of the law, and to encourage NRC staff to provide complete and accurate information to the various elements of the public we serve. Aside from information that might compromise national security and certain proprietary information, NRC cannot withhold information basic to our decisions.
The fifth and final principle is that of reliability. and promptly, fairly and decisively administered so as to lend stability to the nuclear operational and planning processes. Reliability has a number of aspects - it must be based on the fullest possible understanding of technical and operational considerations; it should be timely and fair; it should have a certain stability. We have been criticized primarily on the latter two counts, so I would like to focus on these.
The third principle is that of efficiency. "The American taxpayer, the rate-paying consumer, and licensees are all entitled to the best possible management and administration of regulatory activities. The highest technical and managerial competence is required, and must be a constant agency goal. NRC must establish means to evaluate and continually upgrade its regulatory capabilities. Regulatory activities should be consistent with the degree of risk reduction they achieve. Where several effective alternatives are available, the option which minimizes the use of resources should be adopted. Regulatory decisions should be made without undue delay."
We are perhaps most criticized for perceived inequities in the treatment of different licensees. Different inspectors and different regions are believed to vary in strictness and in interpretations of regulations. Some of these criticisms probably valid, and we need to reemphasize to staff the need for consistency and coordination, and strict adherence to the actual regulations. I think we are doing a better job of this now. However, I would like to caution you that things are not always what they seem to be. I have personally asked many times for specific examples to support the allegation of NRC inconsistency and have gotten little response. Further, in some cases where there are real differences, there may be good justification for them. In one case I recently looked into, there appeared to be an inconsistency in the way two different regions treated two licensees for the same incident. However, the facts of the case suggest a good justification for NRC's actions in each case. The first occurrence of the incident had to be examined closely and therefore took time and effort on the part of both NRC and the licensee to resolve; the second licensee to experience the same incident effectively reaped the benefits of what NRC had learned in the first case. Thus, the second incident was resolved much more quickly, with fewer demands on the licensee, than had been the first incident. Unequal treatment? Yes. Unfair? I don't think So. In fact, I view this case as an example of good coordination and information exchange between the NRC regions. I do not want to excuse those cases where NRC's treatment of licensees has been unjustifiably unfair, but I do urge you to try to understand NRC'S perspective. on our part, we need to communicate better to help you understand why apparently similar situations sometimes may properly require quite different responses from us.
This principle really has two distinct components technical and managerial competence, and use of a risk-related basis for decisions. Let's look at each of these.
The apparent lack of regulatory stability is often criticized by industry. I think there is certainly some validity to the charge In the past decade, our regulations have increased rapidly, largely as a consequence of Three Mile Island. We have also tried to incorporate the benefits of new research knowledge. In some areas, we probably did too much too fast. To some extent, we lost sight of the relative importance of each new measure to overall safety.
My next example is the Commission's well-publicized Policy Statement on Below Regulatory concern announced in July 1990. This policy statement addresses the issue of when the level of radioactivity in a material may be considered so low that full regulatory control is not necessary or practical. It establishes a consistent framework for making exemption decisions when petitions are received and in developing pertinent regulations and guidance. It will also serve as a basis for reviewing old exemption decisions to assure their adequacy. The decisions this policy should support relate, for example, to site cleanup, or recycling of materials used at nuclear facilities, and the broad distribution of consumer products, such as smoke detectors.
Unfortunately the policy statement has been widely misinterpreted by members of the public as the equivalent of a rule. Still, I believe the Commission's BRC policy meets the test of Good Regulatory Practice for the following reasons.
We did not adequately address systems considerations, and in some cases, requirements introduced to improve safety in one way may have been detrimental in other ways. We have been trying to put more discipline into the process. We now have the Backfit Rule, which requires that decisions be based on cost-benefit considerations, unless they are essential to adequate protection. The Commissioners and the staff are also more sensitive to the issue, and we try to look closely at the need for any proposed changes. Therefore, we certainly welcome feedback on the impacts proposed changes may have on operations and safety. On the other hand, you must all realize that regulatory stability cannot mean regulatory rigor mortis. Nuclear power is still a relatively new technology, and our knowledge is increasing all the time. We need to keep improving safety performance through improved standards and improved operations, but we need to do so in a way that reduces the negative side effects we have sometimes generated in the past. NRC is examining the possibility of instituting an internal review that would help improve the evolution of regulatory requirements. Perhaps some examples of current applications of the Principles of Good Regulation will be illustrative. My examples include development an approach to a possible Maintenance Rule; development of the Part 52 process for Standard Design Certification; and development of the Below Regulatory concern Policy Statement. I will point out that the Principles of Good Regulatory Practice do not include either avoidance of controversy or striving for popularity with all segments of the community we serve.
Openness - A draft of the BRC policy statement was published for comment and all comments were considered in development of the final statement. To supplement this information, the NRC convened an international conference to discuss BRC concepts. When the final statement was released, the Federal Register Notice was supplemented by extensive public information efforts, such as press interviews, briefings of Congressional members and representatives of Federal agencies, conduct of workshops in each of NRC's five regions, and distribution of brochures to the Agreement States and interested members of the public. All of these actions were in attempt to explain the policy and the Commission's future actions in this area.
DEVELOPMENT OF A MAINTENANCE RULE
As you will recall, in June 1989 the Commission elected to hold further rulemaking in abeyance for an 18 month period to allow the staff to continue an assessment of industry progress in improving industry maintenance and to provide recommendations on the need, if any, for additional regulatory action. In September 1989, the Commission directed the staff to establish specific criteria to be used in determining whether a maintenance rule would be necessary. In May 1990, The Commission endorsed the staff general criteria, urged caution in evaluating a Maintenance Performance Indicator, and identified a number of other factors which may influence the Commission's final determination on this issue. In June 1990 the Commission directed the staff to develop in addition to the prescriptive, process-oriented rule initially proposed, alternative reliability-based, results-oriented, non-prescriptive rule which would focus on results rather than on methods, with a supporting Regulatory Guide.
clarity The policy was developed to clarify the Commission's process for and considerations in making exemption decisions.
Reliability The policy statement, based on the best available knowledge from research and operational experience, is intended to assure consistency, stability and equity in regulation.
In September 1990, the staff informed the Commission of the results of its Maintenance Effectiveness Indicator Demonstration Program with the staff recommendation not to adopt its indicator of risksignificant component failure rates since it did not conform to broad utility practice owing partly to differences between the agency and industry in the breadth of maintenance activities that could possibly be subject to regulation. Meanwhile continuing assessments of industry progress ce being made through routine SALP evaluations and plant NRR Maintenance Team Inspections.
My third example is standardization and design certification of advanced reactors under the new Part 52 process. The key issue is the level of detail to answer all safety questions, including operational issues, prior to start of construction. How does this regulatory initiative comport with the Principles of Good Regulation? First, let me update you on recent events.
Following the end of the 18-month deferral of action mandated by the Commission, the Commission will consider the progress of the industry in the maintenance area, and possible regulatory approaches, and will make a decision on this matter. Where you ask is evidence of the invisible hand of Principles of Good Regulation in this ongoing activity?
Independence and Openness - The Commission has sought and is continuing to seek all relevant information on the subject of nuclear plant maintenance (and other related complex plant maintenance practices), through Notices in the Federal Register and other mechanisms.
Efficiency The advance decision criteria involving risk reduction attributes have been developed and published. The NRC has made a concerted effort to assure that staff on the maintenance effort have strong credentials in the scientific fields involved, and that significant high-level professional effort is devoted to this subject.
The staff examined the design process in detail to determine the most practical and feasible way to implement the provisions of Part 52 and to provide assurance of an appropriate degree of standardization for different systems. In doing this, the staff acquired knowledge concerning design scheduling and priorities, design products, and inter-disciplinary design interfaces. Staff estimates are being developed as to the level of design detail feasible for different nuclear power plant systems, and the Commission will be considering the staff recommendations.
Clarity We made a special effort to make the revised Policy operational experience. Whatever the final Commission decision on the necessity of a rule in June 1991, I hope that the process by which that decision will have been reached will withstand independent scrutiny and judgement as an example of good regulatory practice.
Openness The process of decision making is making maximum use of public meetings, and requests for public comment on notices in the Federal Register to assure an open airing of all views.
Efficiency The process is being conducted at as rapid a pace to assure stability, consistency, and equity in application. In sum, I believe that the Part 52 design certification process and its key determinate, the required level of design detail, thus far has met the elements, and moreover will eventually be acknowledged as an outstanding example of good regulatory practice. Time does not permit any further discussion of examples, and even for the three I selected to illustrate how agency regulatory initiatives should be guided by the Principles of Good Regulation, the Commission has yet to finish its work.
We are beginning a new wave of introspection at the NRC. I think it will result in better focus and direction for all our activities, in better coordination among them and in higher quality for all our works. We are planning a series of responses to the regulatory impact surveys to address specific concerns identified by the industry and our staff. In doing so will try to translate these principles of good regulation into more specific and detailed statements relating to different activities within the broadly defined nuclear industry. A research philosophy is in place; we are developing a set of inspection principles. You can anticipate some additional changes and improvements over time. However, I will remind you that, as many of you know first hand, institutional cultural change does not come quickly or easily. As we go through this process, I encourage you to continue to give us the feedback that will assist us in identifying and addressing what you consider to be inappropriate regulatory behavior. Like Chairman Carr, who addressed you last year, I want to encourage you to come forward with problems and concerns, especially where you believe safety is an issue. That's the best thing you can do to help us improve our performance, and thus, help us to allow you to do your job better. |
Which of the following is a benefit statement that looks to the future and predicts that something good will happen if you use the product group of answer choices?
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