RCTG Paper

Industry Perspective on 10 CFR 50.59 Issues

Thank you for the invitation to speak here today. After attending this workshop, I much better understand the functions of the Regulatory Compliance and Technology group (RCTG). I also wish to compliment your past achievements with control of regulatory commitments. That effort has helped the nuclear industry greatly.

Many speakers start with a funny story or a good joke. I will attempt neither. But I do have a short animated cartoon that the former chairperson of the NRC, Shirley Ann Jackson inspired. At the 1998 Regulatory Information Conference she emphasized the importance of regulation 10 CFR 50.59 by comparison to a car with unique features that later gets modified and loses some of the needed features.

Modify.avi screen shots

My presentation today will address what's changed with the way we change nuclear power plants, regulatory trends with 10 CFR 50.59, and features of 10 CFR 50.59 programs.

We all know that the terms 'safety evaluation' and 'unreviewed safety question' are no longer used with the revised 10 CFR 50.59. Some may ask, "Where did the safety go?" 10 CFR 50.59 has long been perceived as the process that assures safety; especially before the Electric Power Research Institute issued NSAC-125 in 1989. It's noticeable particularly in 50.59 screens that tend to focus on "is the change safe" rather than "how the change affects the UFSAR." As these terms go away, it provides us an opportunity to emphasize for individuals implementing changes that they are fully accountable for nuclear safety as a part of the change preparation. They should take no credit for the 50.59 process providing safety analyses.

Applicability Determinations

Although not strictly required, all licensees, that I know of, plan to use a three-step process to address changes. For some, the applicability determination is new; others have used similar processes called pre-screenings or licensing change reviews. The applicability determination documents on a check list alternatives to applying 10 CFR 50.59. At first, many thought that not requiring 50.59 evaluations for many activities was like getting a free lunch. I think its better to view the situation as the lunch menu expanded, and more guest are invited to participate. The alternative evaluations should do a superior job of the particular evaluation and may require fewer resources than the 50.59 process. The alternative process must address both the narrow issue, such as a security change, as well as the risk to licensing basis assumptions to avoid evaluations under 10 CFR 50.59 and another process. The need to review for these other regulatory requirements has existed for some time in most cases. The applicability determination formalizes the process. I expect many licensees will perform thousands of applicability determinations each year per site. Some licensees will require an applicability determination for all changes, others may limit the process.

10 CFR 50.59 Screeings

Screening is the most significant change with the revised 10 CFR 50.59. If a proposed activity does or does not change, the UFSAR makes little difference. The question becomes "does it have an adverse affect on a UFSAR-described design function." With the current version of 10 CFR 50.59, a screener has to be able to do a computerized search and read the UFSAR. Now the screener must be able to read the UFSAR and determine if the UFSAR is describing a design function, safety analyses, a method of evaluation, or other information. The new guidance permits changing much of the UFSAR information without a 50.59 evaluation.

Per NEI 96-07, Revision 1, "Design functions are UFSAR-described design bases functions and other SSC functions described in the UFSAR that support or impact design bases functions." NEI 96-07 goes on to quote from NEI 97-04, Appendix B, "Design bases functions are functions performed by SSCs that are (1) required to meet regulations, license conditions, orders or technical specifications, or (2) credited in safety analyses to meet NRC requirements."

10 CFR 50.59 Evaluations

The 10 CFR 50.59 evaluation documents the determination that prior NRC approval is not required for the activity. It uses a 'not more than minimal' concept for four of the eight criteria from 10 CFR 50.59 (c)(2). The current margin of safety question goes away and two more specific questions appear. They deal with fission product barriers and changes in methods of analysis. I strongly recommend that licensees prepare a unit specific list of the fission product barriers for this question. It is much better for select knowledgeable individuals to carefully prepare the list once, than to have each evaluation preparer attempt to determine the list and then compare it to his or her proposed activity.

Many method changes will be fuel or accident analysis related. The fuels and accident analysis group needs to evaluate method changes. These will likely be the most complex methods to justify when the NRC has approved the new method for another unit. Other engineering may have an occasional need to change a UFSAR-described method of evaluation. Since the guidance for method changes is extensive and includes several exceptions, and I estimate fewer than five percent of evaluations will involve method changes, I suggest licensees consider limiting the personnel who may provide a response to this question to the fuels and accident analysis personnel and to select engineers.

Applying the Three-step Process

Licensees need to decide how they plan to document the 50.59 process. Will you require completion of all three process, or will you permit skipping some processes? If an individual knows immediately that an activity requires a 50.59 evaluation, some programs permit skipping the screening. One use for all three processes is to document the portion of a complex activity that requires a particular process(es). For example an activity may include several component and procedure additions and modifications. The applicability determination can identify the portion of the activity that requires evaluation under the maintenance rule and the portion that requires a 50.59 screening. The 50.59 screening identifies the portion of the activity that requires 50.59 evaluation.

10 CFR 50.59 Regulatory Trends

For the years 1998 and 1999 AcroServices conducted research and published a summary of 10 CFR 50.59 violations. In 1998 there were 88 cited violations of the regulations. We did not count non-cited violations in 1998. In 1999 there were only two cited violations of 10 CFR 50.59. Since the NRC revised their inspection program to issue non-cited violations in many situations that previously would be cited, a reduction was expected. However, only 14 non-cited violations were made during 1999. The NRC Enforcement Action Tracking System (EATS) database and public document room information served as our source for violation data.

We explored several possibilities for the reduction in the number of violations. The publication of 10 CFR 50.59 recommended enforcement discretion for violations of the present 10 CFR 50.59 that would not be violations under the revised regulation. With the known major changes pending in 10 CFR 50.59, NRC inspections have not focused on that regulation. In the years following the 1995 Millstone event, many licensees provided extensive focus on their 10 CFR 50.59 programs. They also updated their UFSARs. Once updated, the licensees had added incentive to assure they remain up to date. Perhaps the most significant impact may be from the special NRC panel that reviews potential 10 CFR 50.59 violations. Some inspectors may cite a regulation other than 50.59 to avoid the added interface required with the panel. For example, some failures to incorporate the design bases into the plant design and procedures may be the result of a modification without a proper 50.59 evaluation. Also, one panel purpose is to avoid improper citations of 10 CFR 50.59 violations.

I would like to share some ideas and topics that I feel are a potential risk of regulatory concerns as licensees implement the revised 10 CFR 50.59. The 10 CFR 50.59 process currently functions as the primary means to identify needed changes to the UFSAR for many licensees. 10 CFR 50.59 evaluations and screenings may no longer perform that function. Consider how you will identify the need to change the UFSAR with your revised process. Some changes require consideration of alternative change processes. Many alternatives, other than the maintenance rule 10 CFR 50.65(a)(4) evaluations, fail to consider the impact of the change relative to the plant licensing basis. In such cases, also perform a 50.59 evaluation when necessary. The industry guidance, NEI 96-07, Revision 1, has been carefully prepared to address the issues needed when determining if 10 CFR 50.59 applies or NRC approval is needed. Use it. If personnel presently rely on the 50.59 process for addressing nuclear safety, assure they make necessary process changes to address all needed nuclear safety issues when making changes.

A few years ago, shortly after NEI issued NEI 96-07, we had draft NRC guidance, NUREG 1606, and many, myself included, saw no path that would lead to a single guidance document supported by both the industry and the NRC. Now after years of work by Russ Bell and the NEI task force with the NRC, we really are on the eve of such a single guidance document for the 50.59 process. Without the change in the goals of the NRC that included reducing regulatory burden, I optimistically awaiting the single guidance document.

Improving the 10 CFR 50.59 Process

Next, I'll discuss several aspects of 10 CFR 50.59 programs that licensees are facing as they prepare to implement the revised 10 CFR 50.59. These include revising 50.59 programs, procedures, and guidance; personnel selection and training; and performance support systems.

Some licensees currently have detailed attachments to their procedures. Many of these are derivatives of NSAC-125, now NEI 96-07. I much prefer keeping just administrative information in the procedure. The separate guidance document should be NEI 96-07 with just the clarifications required for a particular unit. The electronic forms help screeners answer the necessary questions. The forms can also take on some added functions such as links to guidance that I'll discuss later under performance support systems.

A recommended starting point for procedures and forms is the USA documents available via the NEI members only web site.

Training and Qualification

Currently most sites qualify many more people than necessary to perform the 50.59 process. Typically a small percentage of qualified individuals perform the majority of the evaluations. With the three-step process, licensees may choose to have separate qualifications for each form. I am aware of some sites that plan to require no specific qualification for their applicability determinations. Others will separately qualify personnel just to perform the determinations. Presently many licensees have separate qualifications for evaluation preparers.

Just-in-time qualification is possible with computer-based training. The large number of students that take a course 'just in case its needed' can avoid the training until the need is really present. Qualification programs should recognize alternatives to the normal qualification process. With the revised regulation, it appears that there will be little variance between programs from one company to another. Qualification programs should be able to take advantage of that situation. In the past I've had individuals who move from job-to-job take essentially the same training program from me at several different sites.

The matrix shows several training options that indicate the variety of training programs planned by licensees. The programs contain a mix of CBT and practical exercises. The applicability determination training that is not shown, typically is a 2-4 hour program. Some licensees include systems, accident analysis, and UFSAR training in their qualification programs which is not reflected in the examples. Key factors in determining the optimum training program are the audience (Are they all experienced engineers or administrative procedure writers?), support systems in place for on-the-job support, and if training is for re-qualification or initial training.

Performance Support Systems

The most important support system will be from support personnel willing and able to answer questions as the industry makes the transition to the revised regulation. Each site needs support personnel. The activity can be a full time position, especially during the transition period. Some site successfully use more broadly based peer support for the 50.59 process. One site I'm familiar with uses a designated support person in each of the major engineering and operations departments to provide one-on-one coaching and informal peer reviews of evaluations. Other sites have a designated group of four to approximately 25 'super qualified' individuals to support the process. Having a small support group during the transition is particularly beneficial to effectively communicate minor program changes.

Intranet based passive performance support systems are currently in use for 10 CFR 50.59. One system example provides links to the procedures, guidance documents, lessons learned, and a qualified personnel list. The AcroHelp performance system operates from the electronic forms used with a word processor. The user gets help for a specific question that includes the industry guidance, site specific guidance, and logic diagrams with explanations for completing the answer to the question.

Summary

10 CFR 50.59 screening and evaluation will require significantly different skills than the current regulation requires. Licensees will need to assure their program addresses the changes. The entire industry should expect to improve both the quality and the efficiency of the process. This will be possible if we maintain a proper perspective and require the important content for the processes and avoid unnecessary requirements. A good support system that includes coaching as well as passive support will help assure a smooth transition to the revised 10 CFR 50.59.