ML20044D240
| ML20044D240 | |
| Person / Time | |
|---|---|
| Issue date: | 05/13/1993 |
| From: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| References | |
| SECY-93-130, NUDOCS 9305180372 | |
| Download: ML20044D240 (75) | |
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POLICY ISSUE May 13, 1993 SECY-93-130 FOR:
The Commissioners FROM:
James M. Taylor Executive Director for Operations
SUBJECT:
REGULATORY IMPACT SURVEY FOR FUEL CYCLE AND MATERIALS LICENSEES PURPOSE:
< To inform the Commission of the results of the first phase of the survey, to recommend changes in the Nuclear Regulatory Commission regulation based on consideration of licensee comments, and to recommend a plan for obtaining a broader range of licensee views on the efficacy of NRC's regulation.
SUMMARY
In accordance with Commission direction, the staff conducted onsite surveys of five fuel' cycle and four major materials facilities over the period August 25 to.0ctober 16, 1992. The staff received a wide variety of-licensee reaction i
to NRC's regulatory program which is detailed in an enclosure to this paper.
Licensee views led the staff to consider actions related to timeliness of
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licensing, updating of regulations and guidance, re'iiance on industry standards, qualifications of inspectors and license reviewers, responses to incidents, team assessments and 50.59 type changes. Many of the comments were in areas already being addressed by other staff initiatives. The staff also recommends a continuing effort to obtain information from licensees on regulatory impact.
NOTE:
TO BE MADE PUELICLY AVAILABLE Contacts.
Carl J. Paperiello, NMSS Y!IENTHEFINALSRM'ISMADE 504-2659 a/AILABLE Paul Goldberg, NMSS 504-2631 t-4 1(pb136
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i The Comm'ssioners r BACKGROUND:
In a staff requirements memorandum dated February 3, 1992 the Commission instructed the staff to prepare a proposal for a regulatory impact survey of fuel cycle and materials licensees.
The staff submitted a plan for Commission approval in SECY-92-166. The plan recommended including medical licensees and recommended conducting the survey in phases because of the level of resources required b the full program.
The staff proposed the following phases:
(1) a pilot series of no more than nine onsite interviews at fuel cycle and large materials facilities; (2) a mail survey of approximately 50 percent of licensees (roughly 3,000); and (3) a subsequent set of about 40 interviews.
Following the first phase -- the pilot interviews -- the staff would analyze the results and make a recommendation to the Comm bsion on whether to proceed with the mail questionnaires and the remainder of the onsite interviews. The Commission approved the staff's plan to proceed in phases ir a staff l
requirements memorandum dated May 28, 1992 (Enclosure 3). The Regulatory Impact Survey Report is Enclosure 1 to this paper. The Staff Requirements r
Memorandum on NUREG-1324 and the Staff Action Plan are in Enclosure 4.
DISCUSSION:
In phase 1 of the survey, the staff conducted interviews at five fuel cycle facilities, two major manufacturers, and two universities with broadscope licenses between August 25 and October 16, 1992. The NRC teams discussed the following six general areas with licensees according to a structured protocol (Enclosure 2):
1.
Regulations, policy, and regulatory guidance 2.
Licensing l
3.
Inspections 4.
Reporting requirements 5.
Enforcement and Investigations l
6.
Fees Results As the enclosed report describes in detail, the staff obtained a wide variety of licensee reactions in these areas.
Some views were generally or widely expressed; others were expressed by one or a small number of licenseas but had more general implications. The following licensee observations are the most significant for materials regulation:
I o
While licensees expressed some misgivings about NRC's approach to regulation and a few concerns about expertise and attitudes of staff, NRC as a whole and individual NRC staff were generally viewed well, especially compared to other federal and state regulators.
Staff deficiencies were primarily weaknesses in technical knowledge or experience and not conduct.
Licensees' concerns centered, for the most
j The Commissioners )
1 part, around the NRC's assignment of inspectors la: king adequate
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knowledge of specific technical disciplines and processes relevant to 1
their facilities, particularly in response to incidents and on Team Assessments.
Problems with licensing generally had more to do with resource and management issues than with reviewer competence or helpfulness, although several fuel cycle licensees stated that reviewers sometimes reed more acquaintance with their plants; these licensees felt that new reviewers acquired this with time.
Licensees also said that NRC expertise in criticality was limited to a few people in headquarters. Most licensees were able and willing to appeal staff decisions to NRC management.
o Licensees expressed significant concern with the timeliness of licensing actions, particularly approvels for distribution, license renewals, and fuel facility amendments other than security and safeguards.
Delays in licensing actions can have significant economic consequences.
i Individual staff performance in this area is generally considered good.
1 However, licensees believe the NRC licensing staff is overloaded with work, nas a relatively high turnover, and, in the area of fuel facilities, lacks clear guidance from management with respect to acceptance criteria.
o Fuel facilities are, for the most part, dissatisfied with the depth and extent of regulation.
They feel that NRC overreacted to particular incidents at fuel cycle facilities by imposing through licensing actions the recommendations contained in NUREG-1324, " Proposed Method for j
Regulating Major Materials Licensees" and by trying to regulate them in the same way the agency regulates power reactors. A number of them would prefer that NRC move toward more performance-based regulation.
Their view is that requirements and information on compliance are not incorporated into regulations and guidance, as they should be, but are imposed in less formal ways, through license conditions and inspections, permitting excesses in regulation while leaving licensees little opportunity for comn.ent or appeal.
Licensees strongly objected to what they viewed as imposition of new reporting requirements through Bulletin.
l 91-01, Reporting Loss of Criticality Controls.
o Licensees are concerned that a number of licensing guides are out of date, in apparent conflict with regulations, or were issued only for comment and never formally issued in final form.
Licensees objected to requirements imposed by license conditions based on NMSS internal guidance to reviewers and Bulletins primarily because these do not receive industry review and comment prior to issuance and not because of their relatively informal regulatory nature.
o Licensees in general wanted to have more and earlier involvement in Jevelopment of regulations and regulatory guides, and, as suggested above, they wanted NRC to issue its requirements in the form of rules and regulatory guides to permit mcre and earlier comment and to clearly
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communicate NRC standards and expectations.
Several explicitly I
recommended longer comment periods for rules and formal comment' periods for Regulatory Guides and less formal guidance.
Licensees believe that NRC's safety goals can be met more efficiently if o
NRC endorses industry and consensus professional standards, cooperates in developing and updating them, and recognizes licensee self-management of safety. A number of licensees pointed to such standards issued.by industry (Chemical Manufacturers Association), standard-setting organizations (International Standards Organization,. American Society for Testing and Materials, American National Standards Institute),
professional organizations (Health Phyics Society), owners' groups (Quality Assurance for conversion facilities), and other agencies
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(Occupational Safety and Health Administration, Department of Energy) as i
well as management practices such as Total Quality Management which they
-l use, often voluntarily, to meet their own internal safety requirements.
j A number of licensees, particularly fuel facihties, believe that NRC o
overreacts to incidents, often does not respond in a coordinated fashion, and, on occasion, sends inspectors without the necessary background to respond to incidents. They consider the NRC too quick to send inspectors or teams to the site and, in some cases, believe that -
the onsite NRC presence interferes'with controlling and recovering from the incident.
Five licensees stated that, once an event is reported, they are heavily burdened with repetitive calls-from seve<. NRC organizations asking similar questions, often pulling key licensee personnel away from handling the event.
Recent incident reporting requirements established in 10 CFR 30.50, 10 CFR 40.60 and 10 CFR 70.50 were seen as having too low a threshold.
However, licensee concerns over incident reporting were perceived to be a' consequence of the NRC reaction to the report more than the burden of making the initial report.
Team inspections were.onsidered a major burden by the licensees o
experiencing them. They had to devote at least one of their staff to each member of the team. Although production was not affected, much 4
licensee overtime was mpended making up for time lost during the inspection.
Some teams were too large for the size of the licensee's professional staff and other team inspections appeared disorganized.
The participation for EPA and OSHA on NRC teams received mixed views.
Several considered them useful in principle but noted that these other federal agencies rarely conduct routine inspections like the NRC.
o Licer; sees wanted provisions in the rules similar to 10 CFR 50.59 for reactors to permit greater flexibility in changing operations without NRC approval when there is no unreviewed safety question involved.
o Enforcement in the form of fines is a deterrent but primarily because of
The Commissioners l adverse public attention.
o Fees elicited various forms of avoidance behavior but did not appear to impact the safety of NRC licensed activities.
i Possible Reoulatory Chances The findings of this survey suggest a number of possible regulatory changes, some of which are already underway as a result of the NUREG-1324 Staff Action Pl.an, the reorganization of HMSS, and the medical regulations review.
Responses to the findings of the Survey will be integrated into these activities. The following actions address some of the changes either underway or being considered to respond to the results of the survey.
In addition, the results of the survey will be distributed to appropriate NRC offices for review and further action as deemed necessary.
1.
Timeliness of licensing j
One of the principal goals of the reorganization of NMSS is to improve the timeliness of fuel cycle licensing, including reducing the backlog of cases in
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timely renewal and implementing the 10-year term for license renewals.
To j
improve the timeliness of fuel cycle licensing amendments and renewals, a new Licensing Branch has been formed in the Division of fuel Cycle Safety and Safeguards to focus solely on safeguards and safety licendng activitics,
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including improvi..g the process.
l In addition, the staff is considering and implementing the Commission's direction in its Staff Requirements Memorandum on the Staff Action Plan and i
NUREG-1324 (M921113A, January 15, 1993, Enclosure 4), in which the Commission l
put additional emphasis on license reneuals, directing the staff to carefully consider the license renewal process for major fuel cycle licensees and to l
factor it into the staff's final action plan.
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The staff expects these measures to improve the timeliness of licensing for fuel cycle facilities.
i NMSS has improved processing time for registrations for sealed sources and devices and has established priorities which require dealing first with registrations for active sources and devir" and those associated with licensing actions, and next with fee-relatu registration actions such as suspensions and consolidations of registrations.
Region-based license renewal will be reviewed during the 1993 National Program Review and actions proposed based on the findings.
2.
Review cycle for regulations and guidance The medium and high priority actions from the Staff Action Plan mentioned in
- 1. above should help to make the regulatory framework for fuel cycle facilities more complete and up to date. The Commission's SRM emphasized
The Commissioners I upgrading of the regulatory framework and the NMSS reorganization will permit a continuing focus on this goal. However, due to resource constraints, updating of all the relevant guides is presently a low priority item in the Staff Action Plan. Updating of regulatory guides has typically been a low priority item in the budget process.
Under the most ideal circumstances NRC regulations should be performance based.
Regulatory guides would be primarily focused on license applications and would summarize those regulations applicable to a given activity. Where po.ssible, technical guidance on meeting the performance standards would come from industry consensus standards endorsed by the NRC. The NRC resources saved by reducing the number of regulatory guides that the NRC supports could' allow a more frequent review of the remainder. As noted in 3 below the staff will consider this option.
4 3.
Reliance on industry standards In response to licensee comments as well as the Commission's recent SRM, the staff will consider whether and how NRC might make greater use of standards t
issued by industry, professional, standard-setting and other organizations in regulation of radiological safety and in regulations related to other matters, such as chemical safety. However, it needs to be remembered that the NRC is a major source of technical evaluation standards in the nuclear area. Some of the documents developed by the above organizations make use of NRC sponsored research or NRC guidance.
- 4. - Oversight of licensing and inspection staff As noted above, licensees generally had a favorable view of the NRC staff
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members with whom they dealt on licensing and-inspection, although some deficiencies in technical knowledge or experience were noted.
The reorganization of NMS$ should help to allow staff to gain more experience over a period of time with licensee-specific issues.
In addition, the Staff Action Plan places a high priority on development of training courses in fuel cycle technology and criticality, which should aid greatly in improving the breadth of staff expertise for both inspectors and licensing staff in these areas, provided that staff vacancies in these critical areas can be filled.
5.
Coordination of responses to incidents In response to licensee concern about NRC overreaction to incidents, the staff will consider:
1.) whether it responds too quickly and intensely to incidents and, if necessary, how to better calibrate its response and; 2.)
how to improve coordination of its response to incidents. The staff will
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report its conclusions and recommendations to the Commission.
6.
Team Assessments The SRM directs the staff to focus on the regulatory basis for major materials i
1 The Commissioners :
licensees, " deferring team assessments until staff provides the Commission with an analysis of team assessments and alternatives." The staff will 1
conduct the requested analysis and report its conclusions and recommendations
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to the Commission.
7.
50.59-Type Changes
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Licensees generally wanted a provision in the rules similar to 10 CFR 50.59 for reactors, allowing them greater flexibility in making design and operational changes, without prior. Commission approval when the change did l
not involve an unreviewed safety question.
Licensees would have to document such changes and they would be subject to inspection. A proposal of this tyoe is already under consideration as part of the Staff Action Plan.
EXPANSION OF THE SURVEY The Commission requested the staff to provide it with a recommendation whether i
or not to continue with further phases of the regulatory impact survey based t
on the results of Phase I of this survey.
Reviewing these results, there i
appear to be several alternatives.
t Option 1.
Defer further survey work and concentrate on correcting problems identified in this survey, t
PRO a) This option is the least costly in dollars and FTE.
Scarce i
resources can be used to correct problems identified in this survey.
b)
Little more will likely be learned with respect to licensing timeliness, adequacy of feedback on rulemaking, staff knowledge, impact of event reports, and the impact of fees on licensee j
decisions.
CON a) This option lacks input from medium and small licensees as well as the medical community on clarity of licensing and regulatory guidance.
b)
Smaller licensees tend to get less experienced inspectors and i
licensing reviewers which may affect responses.
c) Many smaller licensees do not have full time regulatory affairs managers or Radiation Safety Officers which may affect responses.
I Option 2.
To systematically integrate consideration of regulatory impact into the regulatory program, make discussion of regulatory impact a part of the frequent interactions which l
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The Commissioners NMSS and the Regions have with various segments of the licensee community, such as meetings, workshops, and i
comments on rulemaking, and incorporate the feedback into the continuing development and application of the regulatory framework.
PRO a)
Probably the least costly additional effort.
b)
Discussion can be optimized to the interests of the industry group participating in the workshop.
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c)
Feedback would likely be fairly current.
CON a) Bias towards larger licensees who can afford and have interest in participating in interactions.
i b)
Project will be stretched out over a long time period, c) May suffer from group-think from meeting attendees, i.e., through 1
informal discussions, participants coalesce around one or a few ideas or issues rather than presenting a full range of views.
Option 3.
After the completion of each inspection and licensing action for a three month period, the licensee would be given a short questionnaire providing feedback on their view of the service provided by the NRC. The form would be sent to a neutral office such as a contractor.
PR0 a)
Lower immediate burden on staff. Contractor could be used to tabulate results for licensing and inspection.
b) Responses will be based on current activities.
c) Results can be statistically evaluated and differences between work groups evaluated.
d) Changes with time can be evaluated.
e) Will likely modify staff conduct favorably.
f) Most likely approach that will ensure feedback from small licensees and in all industries regulated.
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4 The Commissioners CON 1
a)
Project will take an extended period of time.
b) The totality of regulatory impact will be harder to assess.
This assessment will eventually require staff resources, i
c) May be biased when inspection results in significant enforcement.
d) May inhibit inspectors and license reviewers.
NRC staff reaction may be negative.
Ootion 4.
Proceed with original proposal. Mail short questionnaires to about 3000 licensees and conduct in-depth interviews of about 40 licensees.
PRO a) Bounded action and project will have an identifiable conclusion.
b) The survey will cover all licensees in all areas of regulatory interface.
c)
Results can be evaluated statistically.
d)
Ensures survey of all types of licensees.
CON a)
Likely to be the'most _ costly; particularly for interviews.
b) The limited length of questionnaire sent in a mass mailing may result in superficiality.
i c)
Some bias in that unhappy licensees may be more likely to return surveys.
Some selectivity in returns.
d)
Since the last interaction with the NRC may have been one or more years in the past for small licensees, feedback may not be current.
RECOMMENDATION:
The costs of any expanded survey need to be considered.
Based on Phase 1 costs of approximately 1 FTE, a significant portion of which was spent in preparing the Protocol and preparing the enclosed report, the I
staff has estimated the costs of the options listed above. Option 1 incurs no additional costs.
Option 2 would also not incur any additional cost.
Option 3,
if questionnaires were given to about 1500 licensees, would cost about 5175,000 and ~ 0.25 FTE for contract administration.
Option 4 would cost about j
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The Commissioners 5210,000 if half the questionnaires were returned but could cost as much as 5325,000 if most were returned. Option 4 would also cost about 2.5 FTE, primarily in the conduct of onsite interviews and analysis of the data gathered therein.
The staff recommends that the Commission approve Option 2.
This 3
recommendation is the most cost-effective approach to gaining the views of j
licensees on the impact of NRC's regulatory program, taking into account the serious resource constraints under which the agency is operating.
By building consideration of regulatory impacts into routine and special topics workshops su' h as the. Fuel Cycle workshop, radiographers workshop, etc., the staff would c
have the opportunity to discuss and'come to a better understanding of licensees' views. Although this approach would not permit surveying as large a number of licensees as originally planned, a relatively broad cross-section of types of licensees could be included in this approach. Option 2 would not require a Paperwork Reduction Act clearance from the Office of Management and Budget while Options 3 and 4 would.
COORDINATION:
The Office of General Counsel has reviewed this paper and has no legal objection.
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Jam s M.M)tr.
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Ex utive Director i
for Operations l
Enclosures:
1.
Report 2.
Protocol 3.
Regulatory Impact SRM 4.
NUREG-1324/ Task Action Plan SRM i
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' Commissioners' comments or consent should be provided directly to the Office of the Secretary by COB Friday, May 28,-1993.
r Commission Staff Office comments, if any, should be submitted to the Commissioners NLT Friday, May 21, 1993, with an infor-l mation. copy to the Office of the Secretary.
If the paper is j
of such a nature.that it requires additional review and' comment, the Commissioners and the Secretariat should be apprised of l
when comments may be expected.
i DISTRIBUTION:
l Commissioners OGC l
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EDO REGIONAL OFFICES i
SECY
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i DRAFT REGULATORY IMPACT SURVEY F
Section 1 INTRODUCTION At the direction of the Commission the NRC staff conducted a preliminary survey of the impact of regulations on byproduct i
material and fuel facility licensees between August and October 1992.
The survey followed a similar survey of power reactor
~l li,censees conducted in 1989.
The results of-the survey presented here reflect the views of the licensees unless otherwise noted.
Many of the licensee positions stated in this report have been heard previously in other fora.
There has been no attempt in this report to present staff positions.
In the fall of 1989, the staff initiated a survey of utilities to determine the impact of regulation on power reactors.
This effort was modeled on a survey conducted in 1981 to determine utility views on the effect of the many NRC regulatory initiatives and requirements imposed following the accident at Three Mile Island Unit 2.
The purpose of the regulatory impact survey begun in 1989 was to determine industry perceptions of the effect of NRC's activities on the safe operation of nuclear power plants and to assist the staff in determining if its regulatory programs required modification.
Two related surveys examined the views of NRC staff on the impact of regulation and the time spent by licensee management in responding to 11 Kinds of inspections and audits.
Teams of senior NRC managers held discussion sessions with a broad spectrum of licensee representatives, ranging from plant operators and engineers to several Chief Executive Officers, at 13 utilities throughout the country.
Following evaluation of the results of the three surveys, the NRC made several changes in policy and practice related to regulation of reactors:
1 1.
The NRC staff considers the cumulative impact of generic communications by allowing for public comment on the scope and schedule of proposed generic communications and by ranking generic communications according to their safety significance and publishing the ranking periodical'ly.
2.
The scheduling and control of inspections are achieved by announcing all inspections unless notification would
compromise the staff's ability to obtain an accurate assessment of the licensee's activities and by limiting the number of major team inspections at each site.
3.
The training of inspectors has been improved.
4.
Requirements have been established for enhanced f
management supervision of field activities.
In a memorandum dated August 2, 1990, the Deputy EDO for Nuclear Materials Safety, Safeguards, and Operations Support asked the r'
Director of NMSS to provide a plan for, and consider conducting, a survey of staff involved in licensing and inspection of materials facilities to obtain their insights bearing on the perceived problems in the NRC's regulatory scheme.
This survey i
would be similar to the survey of staff involved in reactor regulation, reported to the Commission in SECY 90-250. NMSS conducted its survey between November, 1990 and January, 1991.
In a staff requirements memorandum of November 6, 1991, which t
followed a briefing on an incident at General Electric-Wilmington, the Commission directed the staff to evaluate the desirability of conducting a regulatory impact survey for fuel cycle facilities and major materials licensees and to provide a recommendation to the Commission.
In SECY-92-005, the staff reported on the survey >>f NRC staff described above and recommended that the taaff not conduct a survey of licensees at 3
that time because the costs of conducting the survey seemed to l
outweigh the potential benefits.
l The Commission conveyed its disagreement with the staff recommendation in a staff requirements memorandum dated February 3,
1992 and instructed the staff to prepare a proposal for a regulatory impact survey for' Commission consideration.
The proposal was to discuss the proposed size of the survey, whether 1
to include medical licensees, resource limitations, and the impact on competing staff priorities.
The staff submitted a plan for Commission approval in SECY 166.
The plan recommended including medical licensees and recommended conducting the survey in phases because of the level 1
of resources required by the full program.
The staff proposed:
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(1) a pilot series of no more than nine onsite interviews at fuel' cycle and large materials facilities; (2) a mail survey of approximately 50 percent of licensees (roughly 3,000) ; and (3) a subsequent set of about 40 interviews.
Following the first phase
-- the pilot interviews -- the staff would analyze the results and make a recommendation to the Commission on whether to proceed with the mail questionnaires and the remainder of the onsite i
interviews.
The Commission approved the staff's plan to proceed in phases in a staff requirements memorandum dated May 28, 1992.
The staff then prepared a project plan and a protocol for the interviews, selected the nine facilities, developed a schedule,
and secured the participation of Regional and NMSS personnel.
The interviews, conducted between August 25 and October 16, 1992, involved five fuel cycle facilities, two major manufacturers, and two universities with broadscope licenses.
i Carl Paperiello, Deputy Regional Administrator of Region III, served as Project Director and as Team Leader for all nine interviews.
Paul Goldberg of NMSS was the Project Manager and accompanied all the teams to the facilities.
Below is the schedule of facility visits and list of other team members.
Recion Date Facility Team Members 1
RY 8/25/92 Siemens (ANF)
John Greeves, NMSS William Cline, RII Patricia Rathbun, NMSS RI 9/15/92 DuPont Merck John Glenn, NMSS 9/16/92 Harvard University / Bruce Mallett, RII associated hospitals 9/22/92 Massachusetts Institute of Technology RIII 9/29/92 Allied Signal Robert Bernero, NMSS 9/30/92 CE-Hematite Douglas Collins, RII 10/1/92 Mallinckrodt RII 10/15/92 NFS-Erwin Malcolm Knapp, NMSS 10/16/92 Westinghouse, Robert Burnett, NMSS Columbia The survey was conducted to obtain the views of fuel cycle and materials licensees regarding the impact of NRC's regulatory program on safety and safeguards at licensed facilities.
Licensees were initially contacted by phone or in person to ascertain their willingness to participate.
All those initially contacted were willing, indeed eager, to participate.
NMSS and the Regions agreed with the licensees on personnel to be interviewed.
The NRC personnel stayed together as teams to interview groups of licensee personnel, mostly management, ranging from corporate and top onsite management to first-level management and senior technical staff.
With one exception, the interviews required about a full day at each licensee's facility, during which time, the NRC teams discussed the following six general areas according to a structured protocol:
1.
Regulations, policy, and regulatory guidance, 2.
Licensing, 3.
Inspections, 3
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Section 2 REGULATIONS AND REGULATORY GUIDANCE The licensees participating in this survey were very knowledgeable of NRC regulations, had only an occasional use for consultants, and had commented on proposed regulations.
All had full time staff members involved with NRC regulations.
i Corporations had regulatory affairs managers and health physics j
staffs and the universities had Radiation Safety Officers, Radiation Safety Committees, and health physics staffs.
There was no routine use of consultants to explain NRC regulations and several licensees provided consulting services for clients and customers either formally or informally.
Several used consultants for very specialized services including: computer criticality calculations, computer codes for dose tracking and bioassay, and transportation assistance.
In one case, a retired employee was used part time in his former capacity to help with a license renewal application.
As a regulator the NRC was generally viewed well, especially compared to many other federal and state regulators.
Th3 NRC staff was generally considered the most professional and competent, with an occasional problem with junior staff.
The NRC was seen as usually responsive and open-minded.
Several licensees nc;ed the NRC's willingness to talk to them.
The NRC answers the phone, responds to letters, and returns calls.
There was an implication that several other agencies frequently did not.
One licensee believed that the NRC was deliberately adversarial.
Some staff members, particularly junior staff, were perceived to be rigid.
Almost all licensees believed the NRC staff on occasion would overreact.
All the licensees had commented on new rules.
Their general views of the process were mixed..
Some licensees thought the NRC was rather responsive to comments.
NRC responsiveness to industry feedback on the draft Regulatory Guide on air sampling was noted by several licens ees.
However, most felt comment periods of 90 days or less for proposed rules were too short.
1 These licensees reviewed proposed rules of several agencies.
Commenting on proposed rules took cempeting resources.
Several licensees liked Advanced Notice of Proposed Rule Making and liked the idea of public workshops or. major issues such as 10 CFR Part j
20.
Licensees favored more and earlier interactions.
A number i
stated the NRC should do more to elicit licensee views early in development of standards.
Several stated that when politics came in scientific objectivity was no longer mainte's ed.
They stated that the NRC feared the public and considere( 3ulletin 91-01, Reporting Loss of Criticality Corrtrols, such an example.
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Licensees objected to the imposition of new requirements through license conditions that reviewers were required to impose through internal NRC guidance.
This guidance rarely receives public review or comment.
There was no strong licensee consensus on the best or most useful NRC regulations.
About half the licensees stated that the new 10 CFR Part 20 was an improvement because it was based on an internationally recognized standard.
Three licensees felt it was a good model for regulation because it establishes a high level 4
of expectations and leaves the licensee ample flexibility to meet the goal.
There were major differences between the views of the five fuel facilities and the four manufacturers and universities.
The fuel i
facilities were less satisfied with NRC regulations.
One fuel facility stated that if they were running their business right there would be no need for regulations.
Another stated the NRC l
should only be involved in chemical safety when it impacts radiological safety.
Other safety matters should be left to the Occooational Safety and Health Administration (OSHA) and the Envi.onmental Protection Agency (EPA).
A third fuel facility i
stated that the two major contributors to safety were understanding of the facility design basis and configuration control.
The licensee added that fuel facilities needed a regulation similar to 10 CFR Part 50.59 to reduce the number of modifications that required license amendments.
A fourth fuel l
facility stated that most of its requirements were in its license conditions. This licensee added that it did not feel that license conditions were the appropriate way to impose new requirements.
Two fuel facilities observed that 10 CFR Part 70 lacked-licensing j
standards.
Licensees generally agreed that rules which reflected industry views were among the most useful.
Fuel facilities complained that the NRC was trying to regulate i
them "like a power reactor."
Several licensees stated that NUREG-1324, Proposed Method for Regulating Major Material Licensees, was an overreaction to the GE Wilmington event.
Licensees stated the NUREG was already being implemented by the l
staff.
The other licensees believed the NRC's depth of regulation was f
about right.
One manufacturer stated that the NRC regulations l
were performance based, with the standards being prescriptive but implementation their responsibility.
They considered the
-decommissioning funding plan a good idea because it forces licensees to recognize problems in advance.
A university Radiation Safety Officer (RSO) noted NRC rules have to cover all l
types of licensees with a variety of talents. The RSO stated that
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the NRC was usually flexible in interpretation and 10 CFR has been successful.
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Numerous regulations and requirements were criticized.
Bulletin 91-01 was universally disliked, particularly the four-hour reporting requirement.. Licensees complained that it should have been issued as a regulation and not as a bulletin.
The bulletin concentrated too much on reporting and not safety and it lacked the graded approach in fuel facility emergency preparedness regulations.
As will be discussed under reporting, licensees appeared more concerned with reporting requirements because of.
NRC's reaction to reports than with reporting itself.
There were similar criticisms of new reporting requirements in 10 CFR Part 30.50 and similar requirements in Parts 40 and 70.
Two licensees steted that the requirement to report the slight contamination of the on-site first aid facility when used inhibited its use for injured contaminated workers.
One licensee stated that the proposed rule only required the reporting of contamination of an off-site medica'_ facility if it became contaminated through treating an injured contaminated worker.
During the comment period someone commented that reports should be required for on-site as well as off-site facilities.
This was put in the final rule; however, the on-site facility is under licensee control while an off-site facility is not.
Several licensees stated the contamination reporting limits caused them to spent an inordinate amount of time, effort and external personnel exposure on contanination control.
Only one licensee supported the decommissioning funding rule.
Several licensees stated they should be allowed to self-certify.
~
One university stated that, with an endowment of over a billion dollars, it and a neighboring university in a similar situation should be allowed to self-cert *fy.
One university stated that its decommissioning funding plen cost more than $30,000 in l
external legal fees to set up and $6000 a year in escrow fees to maintain.
Several other licensees noted they were part of very large corporations.
The two manufacturers believed.the off-site portions of their emergency preparedness contingency plans were not needed.
They i
felt that an emergency of a size to need it would be very rare.
They felt the plan unnecessarily alarms the surrounding community.
One added that some aspects of the plan are good and i
help them meet the requirements of other agencies.
Another stated that the money could be better spent elsewhere.
L There were numerous complaints about dual regulation and conflicting regulations by several agencies.
Concerns over the regulation of emissions by the NRC and the EPA were not unexpected.
The manufacturers expressed concern over dual FDA -
NRC regulation (recently-approved changes in NRC package insert requirements should change this).
One licensee noted that OSHA l
regulations in 29 CFR Part 1910 require contingency plans for very hazardous chemicals.
The licensee stated the NRC should 7
l
i build on this regulation and not create new emergency I
preparedness requirements.
One licensee noted there were conflicting OSHA - NRC requirements for its doors.
The NRC was i
interested in keeping doors locked for security purposes while OSHA wants them easily opened to aid in evacuation in case of i
emergency.
Concerns with surveying packages of radioactive material offered for shipment and received were raised by three licensees.
One i
vendor stated that requirements to survey and wipe test for l
contamination every package containing a Technetium - 99M generator adds considerable person-rem but never identifies contamination.
The licensee stated that the design of their facility ensured that the shipping boxes were clean.
One university licensee stated that, in 35 years they had surveyed thousands ~of packages, and only one was contaminated.
A representative of another university stated that they received three to four thousand packages a year.
In 17 years they had never found a contaminated package and very few dose rate discrepancies.
One licensee noted that in spite of the threshold i
on package contents in the current 10 CFR Part 20 they were required to check all packages by their license conditions.
This licensee noted there was no threshold in the new 10 CFR Part 20; however, 10 CFR 35 exempted medical packages from surveys.
Three licensees stated concerns with demonstr'ating compliance with provisions in the new 10 CFR Part 20 limiting the maximum exposure to the public to 100 mrem per year.
l Several issues were raised bv only a single licensee:
2 1.
A university licensee stated that the new requirement in the new 10 CFR Part 20 to obtain the past radiation
)
work history ior all radistion workers would be very costly. The annual staff turnover required them to obtain about 2000 histories per year.
This could cost j
two staff years of effort.
2.
One licensee stated there should be a threshold for material that requires protection from unauthorized removal.
This licensee stated that they were cited for having an autoradiographic plate containing minor quar.tities of radiorctive raterial in an unlocked freezer in an unrestricted area.
3.
One licensee expressed a cancern that the NRC would j
establish as a requjrement an International Atomic Energy Agency (IAEA). proposal that an exporter obtain evidence that a foreign customer was authorized to receive radioacti"e material before it was shipped.
This licensee s&ated different regulatory approaches in foreign countries would make verification very 8
i difficult.
4.
One licensee stated that NRC Eafeguards regulations were excessive.
The licensee stated that the design basis threat for their facility was not credible especially in light of the new world order.
5.
One licensee expressed concern over difficulties getting an amendment for disposal of S-35 (half-life 87 days) by decay in storage.
Decay in storage is permitted for medical licensees for isotopes with' half-lives less than 65 days (10 CFR-Part 35.92).
The licensee stated the amendment was under review for over a year and being reviewed against internal NRC guidance that had never received public review and comment.
6.
One licensee wanted' allowance for color fading of the radiation symbol.
7.
One licensee stated that shipments of low enriched uranium are required to have tamper seals but they are not relieved of analytical.and accounting requirements at the receiving end.
8.
One licensee stated there appeared to be NRC resistance to fixing known problems in 10 CFR 35.
Licensees liked Regulatory Guides as guides but disliked the practice of making a guide a requirement by incorporation into a license condition.
The response was mixed when asked if they i
believed guides were a constraint on innovative approaches to j
solving problems.
One licensee stated that it was the policy of senior corporate management to treat Regulatory Guides essentially as requirements.
Two licensees said Guides were not constraints.
Several said they were constraints under certain conditions such as being incorporated as license conditions.
One licensee stated some inspectors saw Regulatory Guides as requirements.
Several licensees felt that there was too heavy a presumption in favor of guides so that they had to make an overwhelming case for deviation from a guide.
Certain Regulatory Guidec vere regarded very favorably by licensees.
Several licensees found Regulatory Guides 8.13, Instruction Concerning Prenatal Radiation Exposure, and 8.29,
' Instruction Concerning Risks from Occupational Radiation Exposure, very useful and used them directly in their employee training program.
Regulatory Guide 8.25, Air Sampling in the Workplace, received favorable comment.
One licensee stated that the criticality guides were a strength and one licensee stated there was a good effort by the NRC to keep security guides current.
9
There was no consensus on weak or poor guides.
Individual licensees had concerns with Regulatory Guides 8.10, Operating Philosophy for Maintaining occupational Radiation Exposures as Low as is Reasonably Achievable; 8.11, Applications of Bioassay for Uranium; and 8.20, Applications of Bioassay for I-125 and I-131.
In a few cases there were accarent discrepancies between numbers in the regulations and numbers in the Regulatory Guides.
1 Several licensees complained thout the failure of the NRC to keep Regulatory Guides up to date.
The ttree Guides listed above were last revised in the 1970'r.
A significant number of guides
~
including those used as current licensing guides were issued years ago and marked "FOR COMMENT."
Several licensees stated that the NRC needed a formal comment mechanism and fixed comment period for Regu]atory Guides.
In response to an NRC question, licensees cautiously supported the NRC's endorsing industry
^
consensus stendards (e.g., those of the American National Standards Institute and the Health Physics Society), but noted many of these suffer the same age problem as Regulatory Guides.
When asked what changes licensees wa.ted in NRC regulations licensees offered the following:
i 1.
Solve the waste problem.
2.
Develop Unconditional release criteria.
3.
Avoid dual regula. ion.
4.
Consider costs - industry must be competitive.
5.
Consider industry solutions - get comments and give industry realistic time to comment - endorse consensus standards where applicable.
6.
Eliminate " informal" guidance.
7.
Keep Regulatory Guides as guides and not license conditions.
Keep them current.
8.
Abolish recent reporting requirements.
9.
Move to performance based regulations.
10
Section 3 LICENSING Licensees expressed significant concern with the timeliness of licensing actions, particularly license renewal.
Delays in licensing actions have significant economic consequences.
Individual staff performance in this area is generally considered good.
However, licensees believe the NRC licensing staff is overloaded with work, has a relatively high turnover, and in the area of fuel facilities, lacks cleer guidance from management with respect to acceptance criteria.
Most licensees would welcome more site visits by license reviewers, a stable and well-understood fuel facility licensing process and low licensing reviewer turnover.
One licensee stated they thought it would be good for the same person to be b7th the reviewer and the inspector.
Almost every licensee complained about the timeliness of license renewal.
One fuel facility licersee submitted a renewal in early 1990.
This licensee stated that it had to spend money on updating the renewal, as well as submitting amendments to meet business needs.
The licensee stated that the NRC should not ask for renewal until it is ready to process the application.
In the licensee's view it actually had two licenses to maintain in that it had to file amendments or. the currert' license, while constantly updating the renewal.
A second fuel. facility licensee took eight years, and four complete rewrites, to get a license.
This licenseo believes the license wa" only renewed because senior NRC management brought pressure on the staff to issue the license.
A third 'uel facil!'.y liceneee submitted a renewal in April of 1990, and was asked for clarifying information six months later.
Up to 'he date of this survey, it had received no other communication from the NRC.
Four years after a university licensee filed a renewal application, it received a letter to rewrite the renewal application, and resubmit it in thirty (30) days.
A second university 13censee said renewals took an average of 3 to 4 years.
It stated th=.t, because it takes so long to receive a renewal, it may have filed 3 to 5 amendments in the meantime, so the renewal Stas no longer current.
One licensee stated foreign customers queccion the stability of their business when their license is not renewed on time.
Amendments are usually processed in. much more timely fashion than renewals.
Two licensees stated that amendments are almost always processed on time, and most licensees stated that amendments were generally timely to meet business needs.
Regions appear to be faster on proqessing license amendments for universities and manufacturers than Headquarters.
One manufacturer stated that the Region processed amendment requests in six to eight weeks, while Headquarters averaged eight to ten 11
months.
This licensee stated that source registration timeliness was highly variable, and could take from four weeks to eighteen months, and that a distribution license request usually took about eighteen months.
Fuel facility license amendments involving safety appear to take the longest to proces.
One licensee stated that it took eight to nine months to get an amendment approved to move a centrifuge.
A second fuel facility licensee stated that amendments involving security took about two to three weeks, material control and accountability (MC&A) 60 days, and safety six months.
A third fuel facility had an amendment pending for nine months to authorize the possession of a small quantity of Am-241, so it could participate in the EPA Quality Assurance (QA) Cross-Check Program.
Licensees perceived that licensing speed is influenced by turnover of staff, particularly in the Regions, but even in Headquarters, particularly in the area of fuel facilities.
Most licensees stated that if the licensee c6ntacts the NRC and e gla, ins its timeliness needs, amendments will be processed fastet.
Licensing delays rarely had direct safety impact.
The impact was indirect, and licensees incorporated NRC delays in their planning.
There was also a cost impact due to the time and the amendments needed to make changes that would have been permitted if the license had been renewed in a timely fashion.
One licensee provided information that indicated that, at least on one occasion, a licensing delay could have had a significant safety effect.
The licensee applied for an amendment that would allow them to move barrels of uranium nitrate solution into a warehouse to prevent them from freezing and rupturing during the winter.
The amendment was submitted in the mid-summer, but not granted until mid-winter.
Fortunately, the winter was mild.
Eventually licensee senior management called the office director to get the amendment.
The amendment was issued substantially as requested.
Other consequences have been primarily economic.
One manufacturer stated that a delay in getting a sealed source license contributed to the decision not to market a new product, and the eighteen months it usually takes to process distribution actions hampers the marketing and distribution of new products.
This licensee noted there's never been any impact on production.
One fuel facility stated that the time it takes to get an amendment limits their ability to make productivity improvements.
Licensees believe the problem with fuel facility safety reviews is the lack of a standard review plan.
Furthermore, licensees feel, with no formal acceptance criteria, NUREG-1324 is being used informally to pressure them.
Considerable concern was expressed by several fuel facilities licensees over the recent license renewal for Nuclear Fuel Services in which there were more than 60 license conditions.
One licensee stated that they believed that the NRC pushes licensees to use integrated safety analysis and root cause analysis without offering any guidance on what they mean.
One licensee indicated that they believed there 32
4 4
were some weak managers in the NRC who will not make a decision when subordinate reviewers disagree on a matter.
And finally, licensees complained that the NRC will not stop a licensee from
)
over-committing, i.e.,
offering to take safety measures which are j
superfluous.
With few exceptions, licensees were satisfied with individual license reviewer performance.
In response to a question on license reviewer professionalism, most licensees stated that reviewers were always professional in their conduct.
Licensees usually agreed that reviewers were willing to listen to licensee arguments, although there were occasional problems.
Communication with reviewers was usually good, with an occasional delay in returning phone calls.
Of the nina licensees contacted, only one clear example of conduct that a licensee did not consider professional was identified.
In another case, a licensee's amendment was not processed for six months because the assigned reviewer went on leave for an extended period, and upon return from leave, neglected to process the action.
When asked about reviewer helpfulness, licensees stated reviewers were usually helpful.
One licensee indicated that reviewers were not always efficient, and in the fuel' cycle area there were some problems with decisiveness.
One licensee praised the NRC reviewers and their help with rewriting the license when the company underwent a significant reorganization.
Licensees stated i
that reviewers almost always ask clear questions.
One licensee stated that, on occasion, a meeting had to be held to clarify questions.
Three licensees stated that NRC reviewers were technically very competent.
Three other licensees indicated reviewers need, or with time get, on-the-job fuel fccility experience.
One of these licensees stated that reviewerc were long on education, but short on experience.
Two licensees stated that technical competence of NRC reviewers was mixed, and one licensee stated, there was a steady decline in the technical ability of reviewers.
For the I
most part, fuel facilities felt that the NRC had a very few extremely talented criticality experts in Headquarters, but lack j
this expertise elsewhere.
Several licensees indicated there were some problems when reviewers did not know the site very well and J
did not understand the licensee's operation.
Licensees stated l
that reviewers rarely ask for irrelevant information.-
In response to questions, licar. sees stated that reviewers did not appear to be pursuing persor.al agendas.
Reviewers were following the guidanen given.
Licensees, however, complained they do not always know the internal guidance furnished to'NRC reviewers.
Two licensees stated that, occasior. ally, lack of guidance resulted in reviewers pushing their own views.
NUREG-1324 was seen as a signal to reviewers to push conservatism.
One licensee noted they received different opinions from region to region.
This suggested the licensee would discuss the same issue with 13
several regions.
One licensee stated it believed there were some individuals in NRC Headquarters with a personal agenda.
1 All licensees, except one, steted that they knew the appeal process.
However, this licensee had made a significant and effective appeal over a licensir.g delay.
Four of the licensees stated they felt completely unrectraf.ned in appealing a reviewer's decision.
One licensee stated that it felt it to be i
impolitic to appeal.
Three felt restrained, but not in fear of retaliation, and of these, one stated it feared getting an official NRC answer it might not like.
One licensee, who had a large consulting business, ctated it was personally comfortable in appealing a licensing decision, but its small clients were not.
Site visits by NRC licensing staff managers were not very j
common.
Licensee responses to questions on changes observed in licensing practices, and quality of licensing of the past five years were mixed.
An equal number of licensees felt that the process had improved, stayed the same, and declined.
Licensees generally wanted: (1) faster processing of license amendments; (2) greater NRC sensitivity to costs; (3) provisions in the rules similar to 10 CFR 50.59 for reactors to permit greater flexibility in operations.
i i
i 14
Section 4 INSPECTIONS The licensees participating in this survey had been inspected many times, most had received team inspections, and several of the fuel fabrication facilities routinely received customer quality assurance audits.
The major concerns expressed by these licensees generally centered on conduct of team inspections, and their impact on the facility.
They were usually satisfied with routine inspections when they were conducted by experienced inspectors knowledgeable of their facility.
Most inspectors conduct tnemselves at licensees facilities in a i
highly professional manner.
One fuel facility stated that they could not think of an exception.
This licensee stated that, on a few occasions, they have had to ask customer auditors to leave the site.
One licensee it.dicated that, at times, less experienced inspectors become offensive if challenged by the licensee.
This licensee stated that less experienced inspectors sometimes are particularly aggressive in demanding information from individuals who are not authorized to provide it.
Another licensee noted that on occasion, clients iad experienced junior inspectors who looked.for any trivia they could find to issue a citation.
This licensee had 'e"orable experience with two senior inspectors who were subsequently pronoted.
Licensees did not experience cases in which inspectors appeared to impose personal viewpoints or personal agendas.
Licensees did note that different inspectors were inf?.nenced by their bias from prior occupations.
One licensee noted consultants on NRC inspection teams with DOE backgrounds apolied 70E criteria.
Most fuel facilities licensees complaf.ned about inspection team members with reactor backgrounds, who Lad expectations that these licensees felt could not be met.
However, in most cases, strong team leaders were able to fix any problems encountered.
In the licensees' view, inspectors were usually knowledgeable of the rules, regulations and license conditions they were inspecting against.
One licensee was-highly complimentary of the NMSS safeguards staff's kno*tledge and performance orientation.
One licensee, heavily involved in shipping, believed NRC inspectors tend to be weak on transportation regulations.
On occasions, inspectors were aiven essige.ments in response to incidents, for which they were poorly prepared.
A reactor health physics inspector, who was pi: knorledgeable of teletherapy, was sent in response to a teletherapy Lisadministration.
The 1
licensee spent a substantial amount of time teaching the inspector about teletherapy.
- _eactor resident inspector was sent to a feel facility, but was not knowledgeable of fuel facility operations.
One lfcensee expressed disappointment that inspectors appeared to lack knowledge of new and proposed rules.
15
._~
'S One fuel facility expressed concern about the inspectors' 1
expertise in the area of Integrated Safety Analysis.
Inspectors' lack of technical knowledge was not identified as a significant problem.
However, there were some isolated examples of lack of knowledge in specific technical areas.
Fuel facilities generally believed that NRC criticality expertise resided in Headquarters.
Three licensues indicated a lack of l
knowledge of chemistry by certain inspectors.
For two licensees, l
this was a lack of knowledge of chemistry by a fire protection inspector.
For another licensee, it was a lack of knowledge in j
the area of pharmaceutical chemistry.
One licensee stated it i
felt NRC inspectors were weak in the area of international i
l standards.
This licensee also stated it believed the inspectors' knowledge was adequate to identify.a poor program, but insufficient to diagnose the source of the problem.
One licensee stated that there have been significant improvements in inspectors' technical abilities in the last three years and the caw is much better now than five years ago.
Overall, except for chemistry and criticality, the issues identified appeared to be random and not systematic with respect to the technical competence of the inspectors.
Licensees were clearly more p. leased with inspectors who returned repeatedly to their facility.
Licensees believe that inspectors were more effective if they understood the chemical and manufacturing processes at their facilities.
Licensees indicated they believed all inspectors ha.ve to undergo a learning period from the time they first arrive
.t their facility.
This appeared to be more of a problem with fuel facilities then at the other facilities taking part in this survey.
Fuel facilities believed a major problem with team inspections was that many team members had never seen a fuel facil,*.ty before.
One fuel facility licensee felt that all fuel f7cility inspectors should visit every fuel facility in the country as'part of their training.
Most licensees stated that inspectors provided helpful information.
One licensee stated inspectors provided-good advice with no pressure.
Another licensee also indicated the information was provided, but not edicts.
One university stated that in the last two inspecticns, jnspectors made good suggestions and were very kna"ledgeible.
However, at another university, a licensee stef member involved in consulting stated that inspectors should not prn71de advice or information to j
licensees who already have L en.sultant.
One isolated example was provided in which a particular instrument was being recommended for contamination sur/eys that was not the most effective.
Six of the nine licensees stated. that inspectors do focus on safety issues.
Two indicated thair view was mixed, and one said inspectors focus more on compliance '.han on the big picture.
It 16
appeared in this last case that the licensee wanted the inspector to be more accepting of the licensee's management system.
7 Several licensees stated that inspectors spent too much time reviewing paperwork, records, procedures and posting rather-than on the plant floor.
Several licensees indicated that inspector performance has improved in this regard in the past several years.
One licensee stated that the inspector should spend more time looking at the licensee's own internal audits and customer audits to get a broader view of plant activities.
One licensee stated there were some problems with specialists who made their own specialty area the issue the licensee needed to address.
One licensee stated, that even if the inspectors judge the program safe from their own observations, they are not satisfied unless there is extensive documentation to prove safety.
Mos t of the licensees stated that inspectors use their time effactively and efficiently while at the site.
One licensee stated, inspectors cover a lot of ground very quickly, and indicated that a recent audit by a customer in the private sector took so long that the lice <,ee will never bid a job with that customer again.
Another.
ensee stated that the inspectors' use of time was usually good, Eat their operations cover such a large geographic area that it was difficult to be efficient.
This licensee stated it helped if the NRC could avoid frequent changes of inspectors.
One licensee stated, however, an inspector spent two days at a clients' medical facility where there was one camera, one physician and one technetium generator.
One fuel facility licensee stated that the inspector spent too much time looking at records.
As an example of a waste of time, the licensee stated that, at an exit, an inspector said that two of ten thousand records had deficiencies.
In this licensee's view, NRC management wanted meticulous compliance.
This licensee added there was more " bean counting" years ago and that the situation was better now.
Licensees had major concerns with team inspections.
For some licensees, the size of the team was the major burden.
In some cases, the number of team members exceeded the number of professional staff licensees could devote to answering inspector questions.
Most licensees believe they need to devote at least one staff member to each inspector on the team.
In some cases, principally fuel facilities, licensees believe team members with reactor backgrounds had unrealistic expectations.
Some licensees had significant concerns about the fees associated with large team inspections, and their impact on the licensee's budget.
One licensee noted that a large team inspection could cost several hundred thousand dollars.
One licensee complained it received team inspections because there were problems at other facilities.
In two cases, team discipline was weak, and the licensees were either told directly, or heard indirectly, of individuals indicating they were unwilling members of the team.
In one case a licensee stated that they sensed NRC Headquarters team members 17
...m wished to show that the Region had done a poor job regulating the licensee.
One licensee stated that a recent teal inspection provided no prioritization of the findings.
The licensee stated they would need to spend 20,000 staff-hours of effort to follow up on the tenm's open items with only marginal safety gainu.
Another licensee stated that the team approach was useful but the cost / benefit was excessive.
Most routir.e inspections had minimal effect on licensees' routine work.
These licensees had a professional staff to interact with regulatory authorities.
Team inspections had a significant impact on licensees; however, there was no indication that routine production activities were curtailed or shut down as a result of team inspections.
Frequently, the effort devoted by management officials to team inspections had to be made up by overtime during and after the inspection.
One fuel facility.
licensee stated that the timing of a MC&A inspection can be a problem if the inspection occurs while an Mc&A inventory is ongoing because it is essential to complete an MC&A inventory quickly.
Both universities stated that it was very beneficial when the NRC inspector visited labs and talked to people.
The average graduate student welcomed the visit, and discussions with the staff help reinforce the rules.
Licensee stated that findings were almost always clearly presentea at the inspectors' exit.
Although this survey was not intended to explain NRC policies, this is one area in which the team clarified a significant issue for licensees.
Most licensees expressed concern that inspectors would not identify reverity
)
levels of violations.
These licensees were told by the team conducting this survey that it was NRC's policy and practice that inspectors were forbidden to identify probable severity levels of violations.
In almost all cases, technical findings were clearly presented to licensees.
Some licensees expressed concerns there were findings identified as unresolved, which later became viola _Aons (this is not unexpected since an unresolved item by definition will require additional information available only after the inspection to resolve).
Only one licensee indicated that issues appeared on a report that were not discussed during the exit.
One licensee stated the facts provided at exits to senior management were accurate but delivery was weak.
This licensee stated that oral delivery ranged from fair to poor.
priorities, emphasis and trends were not expressed, and perspective was not provided on the importance of various findings.
It was of interest that for this licensee this view was held primarily by the radiation protection staff, and not by the production staff.
A licensee expressed concern with getting Notices of Violations that result from problems with random human error.
Another licensee expressed a concern that a practice that-had been accepted by the NRC for years was found unacceptable by a team inspection.
They believe the NRC was at fault in this area.
18
Most licensees knew how to appeal an inspector's findings to NRC management, and usually felt comfortable doing this.
Several licensees indicated that they have done this in the past and feel completely free to appeal without any fear of retaliation.
All licensees in the survey have had visits from NRC regional management; however, the frequency of visits appeared varied among the Regions.
In most cases, it appeared there was sufficient management accompaniment to sites to have reasonable assurance that regional management was aware of inspection y
activities.
Most licensees observed changes in the NRC inspection process over the past five years.
The views of these changes were mixed.
One licensee indicated that there was a dramatic increase in requirements and inspections, and the MRC was less trusting, and there was too much micro-management Of events.
This licensee believes the problem was with' regional management and not the staff.
Several licensees indicated that inspections had greater depth.
Several licensees indicated that there is a trend away from radiation protection and toward more inspections into the areas of operations, maintenance and procedure.
Another licensee caw that, although the NRC was moving toward more performance-based inspections, there was still too much compliance-based inspection.
There were mixed views on the value of team inspections that included OSHA and EPA representatives.
Three licensees believed they were not very useful; two h.ieved they were somewhat useful; one believed they were useful; and three licensees never experienced such an inspection.
One licensee believed the idea was good, but with fifteen peop]e on the team, the licensee was overwhelmed and the execution of the team inspection was weak.
Licensees indicated that OSHA and EPA inspections are rare compared to the NRC.
One license indicated that OSHA might inspect once in 20 years.
Licensees provided a nu-c
- recommendations for changes in the inspection program.
Tw licet'ees believe that the NRC should licensees stated that the NRC eliminate team inspection should reduce the size of team 11..pections.
Smaller highly trained teams would be more efficient than large teams.
One licensee stated teams should caw findings.
Some suggested sending one or two specialists with the inspector who routinely inspects their facility.
Several licenso.es suggested inspectors spend less time on paperwork and more time directly abrerving activities.
One licensee suggested that certain areas, such as fire protection, be left to other agencies such as OSHA.
Another licensee stated inspectors should spend less time looking at shipping container i
QA records and spend more time looking at the performance of the shipping containers themselves.
A third licensee stated that the 19 I
4 inspector should spend more time looking in the health physics areas of deposition, contemi. nation surveys, and bioassay.
Two licensees indicated the NRC should reduce overall inspection effort, especially if the licensee is performing well. Three licensees expressed a preference for announced inspections in order to schedule the inspector's access to records, facilities and staff. Other suggestions it.clude: (1)'giving licensees more time to implement new regulations before inspecting; (2) i providing a report card at the end of each inspection indicating the areas of good performance, as well as bad performance; (3) having more performance-based inspections; (4) having the same individuals both 1* cense and inspect the licensee; and (5)' having the same inspector or inspectors over a period of time to improve consistency.
I i
1 P
i i
Section 5 REPORTING i
The licensees participating in this survey, with some exceptions, did not find routine reporting requirements a significant burden.
Their major concern was the reporting of off-normal events.
A majority of these licensees believed the NRC over-responded to reported incidents. The magnitude of the response could be a significant burden particularly while the licensee was trying to manage the event or its consequences.
Most of the licensees considered the new reporting regnirements imposed by Bulletin 91-01, 10 CFR 30.50, 10 CFR 40.50 and 10 CFR 70.50 to have excessively low thresholds for event reporting.
The licensees were very knowledgeable of their reporting requirements.
They had received very few citations for reporting violations.
These violations involved misclassification of an event, late reporting of a misadministration, reporting to the wrong NRC organization (two violations) and failure to report loss of a facility with a value in excess of two thousand dollars.
Licensees stated they were always courteously treated when they called the NRC to make a report.
However, they had a few concerns.
Three of the fuel facilities stated that when they call the NRC operations center no one knows what they are talking about.
One licensee stated it spends five minutes explaining that it is not a nuclear power plant.
One licensee stated that the operations center was not aware of fuel facility emergency classifications.
Fuel facility licensees are asked irrelevant questions that are only applicable to power plants.
Five of the licensees stated that once an event was reported they were heavily burdened with calls"from the NRC.
Licensees get repetitive calls from several NRC organizations asking similar questions.
One licensee statad that the NRC caw events.
This l
licensee stated that it was told by '.h? NRC to notify local authorities in one case when there uas only a potential to have a problem.
Several licensees stated the NRC demanded too much information too soon.
One licensee gave an example in which a Preliminary Notification for Tn event was inaccurate because it was issued before the situat'on was f"lly understood.
Four licensees, including two aniversities, one manufacturer, and one fuel facility, said they believed the NRC response to reported events was appropriate.
Two gave examples in which they believe the NRC response was very good.
The other five licensees, including four fuel facilities and one manufacturer, stated they believed the NRC c*rerreacted to events.
One licensee stated the NRC responds by Psking for a great deal of information the licensee does not yet have and by allowing several groups in l
21
i e
the NRC to ask similar questions.
This interferes with the licensee's ability to handle the event.
Another licensee described an event about a year before in which they reported a spill and the following day an inspector arrived.
The licensee stated the spill was in a confined area and the problem was always under control. They considered the inspector's presence unnecessary.
A fuel facility stated that the way an Augmented Inspection Team conducted its activities during an event made it more difficult to recover from the event.
Recovery took more i
than a week and after the first few days the team leader did not remain on site.
The team leader did not have a good understanding of the chemical processes involved and the licensee spent a significant amount of time explaining every change before they could make it.
Several examples of excessive or burdensome routine reporting f
requirements were given:
A.
One licensee stated that the new Part 19 requirement to give annual exposure reports to employees was excessive and an unneeded cost.
Employees could always get their current exposure simply by asking, if they actually wanted it. (Another licensee identified this requirement as a positive change the NRC had made).
B.
One licensee stated that Form 741 may require some i
excessive information but that the licensee needs most of the fundamental data to meet business needs.
One licensee representative stated that DOE's j
reporting requirements in this area were significantly greater.
l C.
One licensee stated it did not know what use the NRC made of the report on exempt distributions required every 5 years.
They added it would be easier to send it annually.
D.
Several licensees questioned what use was made of effluent, environmental, and worker radiological exposure data routinely sent to the NRC.
l P
Licensees suggested the following changes in NRC reporting requirements:
A.
Simplify the SNM transfer report - Form 741.
B.
Put all reporting requirements in the regulations, not in Bulletins.
C.
Require fuel facility event reports to go to the region and not the operations center because the i
operations center does not understand fuel facilities.
D.
Drop the requirement to report contamination of on-4 site medical facilities.
E. The NRC should track individual worker exposures.
l Transient workers hide assignments.
This licensee I
22 i
i i
1 a
r
would have the NRC operate a computer-based radiation worker registry.
F.
Change the regt'.irements for effluent and environmental reporting so only exceptions are reported.
Data are available for inspections.
l.
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1
.l l
1 l
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23 i
l.
Section 6 ENFORCEMENT AND INVESTIGATIONS l
The information provided by these licensees in the area of enforcement and investigations was limited.
Only half described themselves as very knowledgeable.
One licensee stated it was not very knowledgeable and the remainder were somewhat knowledgeable.
Six stated they had read the enforcement policy in 10 CFR Part 2 but one stated it did not understand the policy very well'and one licensee stated they had read it several years ago.
Only one licensee ever had an investigator from the Office of Investigations on site.
Of those licensees who commented, one licensee stated the severity levels in the enforcement policy were very appropriate.
Four stated or implied they were somewhat appropriate.
One licensee stated it did not know enough to comment but it saw no difference between severity level 4 and 5. violations.
One licensee stated that material security should have a threshold.
They had been cited for storing a very small quantity of material unsecured in an unrestricted area.
One licensee stated that Level 1 and Level 2 violations were very clear but almost anything could be out into Level 3.
Finally, one licensee stated that enforcement was much better now than five years ago but the severity levels for transportation violations were completely out of line.
This licensee stated they appeared to be driven more by media concerns than risk.
Seven of the licensees had been involved in escalated enforcement but for one it was almost ten years ago.
Most licensees felt the enforcement conference ' ras useful, issues were clearly communicated, the enforcement _ action was timely, and the appeal process clear.
Most felt oper enforcement conferences would stifle open communication.
The adjestment factors in the enforcement policy did not get much licensee attention.
Fines clearly got licensee attention primarily because of the adverse public attention they drew.
Only one licensee stated they would routinely bring an attorney to an enforcement conference.
This was a matter of corporate policy.
l 1
l 24 1
l Section 7 FEES All licensees participating in this survey were aware of the congressional mandate on fees.
Several fuel facilities asserted that fees should be based on throughput and company size.
One i
licensee stated that they could not understand the derivation of their fee specifically or fuel facility fees in general.
Fees had a variety of impacts on licensees.
One licensee laid off staff.
Two consultants uere divided on whether clients were replacing teletherapy machines with linear accelerators.
One consultant implied that the misadministration rule as much as fees might be driving this decision.
Several university and manufacturing licensees stated that waste disposal costs were of equal or greater concern than' fees.
Competitive position affected what costs could be passed to tha customer.
One fuel facility licensee stated that fees were the difference between a profit and a loss.
One licensee stated that fees affected its international competitiveness.
Manufacturers were concerned with the impact of fees on their customers.
One licensee expressed the view that customers were hit twice, first directly by the NRC fee and second, indirectly, by the higher costs of products from the manufacturer.
No licensee stated it cut safety measures to save on costs as a i
result of fees.
Licensees met rising costs by cutting research and development, deferring capital improvements, cutting marketing travel, and deferring production changes.
Several licensees dropped marginal licenses.
Universities dropped inactive licenses.
License amendments were consolidated to save on fees.
One licensee was consolidating facilities.
Manufacturers dropped distribution licenses for products with marginal profitability.
This has had a significant impact on users of certified shipping containers.
If a vendor of a shipping container terminates its certificate of compliance for a Certified Container, users must either assume the certification costs or buy another type of container.
Licensing fees affected product development decisions.
One manufacturer stated that it looks for nuclear medicine products for which there are no non-nuclear alternatives.
Some licensees were concerned that the NRC had no incentive to control costs.
One licensee felt their fees were impacted by the poor regulatory perforrance of other licensees in its fee category.
One licensee complained that the NRC delay on processing its renewal request resulted in a higher hourly rate for license renewal.
Another licensee stated that fees coerce then to acquiesce on reviewer demands.
If they argue with a reviewer, they are paying for their own efforts as well as the reviewer's efforts.
One licensee manager expressed a concern 25
that direct fee costs were known but was uncertain over the indirect cost of fee avoidance activities by the licensee's 1
staff.
A licensee also noted that when the licensee split i
radiological samples for comparison with the NRC, the licensee's-analytical costs were $100/ sample but the NRC costs, for which they were billed, were $250/ sample.
All the licensees knew whom to contact if they thought their bills were in error.
Several stated that it is very difficult to -
tell for what they are being billed because of the delay in j
billing.
One licensee requ sted advance notice of team
'l inspections for budgeting purposes.
Based on the size of a team inspection it received before full fee recovery, a team
{
inspection could cost it almost $250,000 in fees.
Several other i
licensees objected to team inspections, in part,.because of fees.
i 9
i i
I 26 1
4 i
Section 8 FURTHER ACTIVITIES This report reflects the views of a small number of large licensees concentrated in three categories.
Within that constraint the staff obtained a wide variety of useful views on regulation and its impact on safety.
There does not appear to be much more to be gained by surveying other licensees in these categories.
There does appear to be considerable value in surveying a larger number of licensees in a broader variety of categories.
The staff will consider means for eliciting views of regulation from a wider range of licensees, with emphasis on small and medium-sized licensees.
l 27
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0 s
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NMSS REGULATORY IMPA5T SURVEY 1
UCENSEE NAME:
wwe e
.M-i 2.
i TYPE OF FACILITY:
i DATE OFINTERVIEW:
IndMduals Inteniewai NRC Sunty Team f
l
'i 3
CONFIDENTIALITY STATEMENT: THE RESULTS OF THIS SURVEY WILL BE
}
'USED TO ASSIST THE NRC IN BETTER DETERMINING THE EFFECT OF ITS REGULATORY PROGRAM ON SAFETY AND THE SAFEGUARDING OF NUCLEAR i
MATERIALS. AI.L INFORMATION PROVIDED WHL BE TREATED AS ^
\\
CONFIDENTIAL ONLY MEMBERS OF THE SURVEY TEAM AND DESIGNATED ANALYSTS WILL BE PERMITTED ACCESS TO THE QUESTIONNAIRE DATA.
l YOUR RESPONSES WRL BE GROUPED WITH ALL OTHER RESPONDENTS FOR l
PURPOSES OF ANALYSIS AND WILL NOT BE REPORTED AS INDIVIDUAL
~
ANSWERS.
l l
1 QUESTIONNAIRE NUMBER 1
l
INTRODUCTION THE PURPOSE OF THIS SURVEY IS TO DETERMINE YOUR PERCEPTIONS OF THE OVERALL IMPACT OF A NUMBER OF NRC REGULATORY ACTIVITIES ON THE SAFE OPERATION OF YOUR FACILITY. THE SURVEY WILL TAKE PLACE IN THREE PHASES. DURING THE CURRENT PHASE WT ARE INTERVIEWING PERSONNEL AT NINE FUEL CYCLE AND LARGE MATERIAIS LICENsm a m mMSURhlNCLUDE-ADMINISTERING A WRITTEN QUESTIOtiNAIRE TO A SAMP1&OF LICENSEES AS WELL AS CONDUCTING ADDI'HONAL INTERVIEWS.'
NRC WILL EVALUATE THE INFORMATION GATHERED THROUGH THIS SURVEY IN CONSIDERING WHAT, IF ANY, CHANGES SHOULD BE MADE TO OUR APPROACH TO REGULATING FUEL CYCLE PLANTS AND MATERIALS
- LICENSEES.
WE WILL BE ASKING YOU A SERIES OF QUESTIONS ABOUT YOUR VIEWS ON NRC REGULATIONS, POLICIES AND REGULATORY GUIDANCE; ON LICENSING ACTIVITIES AND THE LICENSING PROCESS; ON NRC INSPECTIONS AND NRC INSPECTORS; ON NRC REFORTING REQUIREMENTS;'
ON THE ENFORCEMENT AND INVESTIGA'110N PROCESS; AND ON THE ~ ~
IMPOSITION OF FEES CHARGED TO LICENSRES. THESE QUESTIONS DEAL WITH SAFEGUARDS AS WELL AS SAFETY ISSUES.
YOUR ANSWERS WILL PROVIDE THE NRC WITH DATA ON SOME OF THE MOST COMPLEX OPERATIONS WHICH THE OFFICE OF NUCLEAR MATERIALS SAFETY AND SAFEGUARDS (NMSS) REGULATES.
WE ANTICIPATE THAT IT WILL TAKE APPROXIMATELY 11/2 HOURS TO.
COMPLETE.
a i
F E
SECTION L REGULATIONS, POLICIES, AND REGULATORY GUIDANCE The purpose of this section of the survey is to obtain your perteptions regarding: the issue of regulatory cost versus safety; to explore with you alternatives to the current regulatory (rune, work, policiiii.or guidanceQaJeg K cucrent, regulatory guidance is helpful or constrains more innovative approaches to meeting regulatory goals; to obtain your views about.your opportunities to provide meaningful comments on proposed regulations and regulatory guides. And, above all, we seek to determine if the NRC is viewed as itsponsiFS,tp M needs and concerns with respect to safety and safeguards,
~
While our questions mentio.n only regulations and regulatory gulds, we are interested in your views on other regulatory documents, such as policy statements, license conditions, branch technical positions, and information' notices. - We invite you to express opinions on'these deemments also in response to goestiontWregulations and guides.
i e
- a. How would you describe your current level of knowledge of the NRC..
regulations applicable to your licensed activities? Would you say it is:
- 1. very hisk
- 2. about average
- 3. Iow
- b. During the past 2 years, have you felt the need to hire outside consultants to assist you in understanding current NRC regulations?
- 1. yes
- 2. no IF YES: Apy. + * -My how much time did they spend?
bl. What about new regulations?
- 1. yes 2.'no 3
J x
4
+-=
1 b2. Specifica9y, har the preanulgation of the new 19 CFR part 20 caused you to him outskK consultants?
- 1. yes
- 2. no
- c. In thinking over the eterrearwt of NR®alatIMuPwkhelyt iryear view, i
provide the grettermkw ta' safety? (which to safeguarding of nuclear i
material?)
-l l
1
- d. Are there any regulations that have little or no safety or safeguards
_. significance,7_ __ _
. 1. yea _
- 2. no
' f d1.IF YES: Which am they?
5 i
d2. What is the basis for your view?
l J
- e. Are them any NRC regulations which might be considend counterproductive to safety? (any counterproductive to safeguarding material froaa theft or diversion?)
- 1. yes
- 2. no el. IF YES: Which are they?
e2. What is the basis for your view?
1
~
4 l
f
- - +
=
s
- _ _____.-_ +,
m
+
ne next set of questions deals with your perceptions ~of NRC regulatory requirements
~
over the past 2-4 years i
- f. ninking back over the past 2-4 years, do you believe there has been a significant increase in NRC requirements?
- 1. yes =...au.... m.
-- _ g g.m, _,.
?
lfl. IF YES: In what areas?
.m.,
I l
For those areas in which changes have occurrur, which have been the most y
3 beneficial to. safety? (which the naast beneficiallo safegnarding of materiaf?)
- b. De least beneficial to safety? (the least beneficial to safeguarding of material?)
4
- 1. What do you believe has been the cost of these regulatory changes?
j.
Do you believe the benefits were proportional to the costs?
- 1. yes
- 2. no l J 1. Why was that?
1 5
i
k.
Can you identifyssy activity you reduced or ethinated which you believe contributed to safety or the safeguarding of material to pay for a new NRC requimnent?
- 1. yes
- 2. no
.~...
p-
- l. Which NRC regulatory guides are the smaat helpful?
W
- m. The least helpful?
n.
Do you see the regulatory guides as a constraint on innovative licensee approaches to sonspthtace with~reguisodas?_
- 1. yes
- 2. no nl. IF YES: Please psevide examples?
6
- o. Have yoq ever commented on proposed NRC'@tions, polley statements or
~
guidance documents?
i:
- 1. yes 2.no
- 3. the opportunity has not arisen
---..e
> i :.,..
~
"V^
~~-+e m pm:p, ol. IF YES: What was your view of the process?
Could you provide examples.
f
- 02. IF NO: Why is that?
i INTERVIEWER NOTER ALIDW RESPONDENT TO COME UP WITH THEIR OWN THOUGHTS ON THE PROCESS. IF THEY DO NOT RESPOND, TRY THE FOLLOWING PROBES:
NOT AWARE OF'OPPOR PROCESS TIME CONSUMING PROCESS CUMBERSOME PROCESS EXPENSIVE PROCESS INEFFECTIVE PROCESS DIFFICULT a
y e
7
c.
p.
How do you view the NRC as compared to other regulatory agencies with
"' ~
- whom you interact?
INTERVIEWER NOTE: USE AS PROBES IF NTCESSARY NRC EFFICIENT NRC CUMBERSOME' ""-
NRC RESPONSIVE
- q. Do the edsting regulations and regulatory guidance achieve their purpose of ensuring the safety and safeguarding of your operation?
- 1. yes e
- 2. no IF NO: Why is that?
'l
=
l gl. Are there any safeguards regulations that have had a negative impact on plant safety?
- 1. ya
- 2. no l IF YES: Which are they?
8
5 e
- r. With respect to rule making and regulatory guidance, how can the NRC i
better meet yourneeds?-
~
- s. In your opinies, daitbimmies and regisistory guidanee focus appropriately on the m@ safety 4ssues-at year faellity?
- 1. yes
- 2. no E YES: PLEASE EXPLAIN l IF NO: WHY IS THAT
.l
- t. If there is com thing you could change with respect to NRCRegulations, Regulatory Guides, Regulatory Pr-what would it be?
l
- u. Do you receive copies of the NMSS Licensee Newsletter?
- 1. Yes
- 2. No i
ul. IF YES: Do you find it useful?
i l
9
u2. An there ways it could be made more useful?...
- 1. Yes
- 2. No IF YES: Please describe them.
SECTION II. LICENSING l
The purpose of the next set of questions is to determine how effectively and efficiently the NRC performs its licensing function. We am attempting to determine if available i
guidance is adequate to penait you to submit an application with reasonable assurance that most of the information will satisfy a license reviewer.
- a. How well dryou believe you understand the review process the NRC uses to Issue, renew or amend a license?
- 1. very won
- 2. moderately
- 3. poorly i
- b. For your licensed activity, do you feel that the guidance provided by the STC enables you to file new applications, amendments, and renewals efficiently?
- 1. yes, most of the time
- 2. yes, some of the time
- 3. no
- c. Does the guidance provided enable you to feel confident that most information you provide will be accepted by the NRC license reviewer?
- 1. yes, most of the time
- 2. yes, some of the time
- 3. no 10
- d. Do you use a consultant when you subadt a license asneedment or renewal request? --
- 1. yes
- 2. no l
ldl. IF YES: WhyTs t!iat?~~
~
~~ ~~
~
1 3
m 1
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1
- e. How timely has the NRC response been to license amendment requests and other licensing requests?
INTERVIEWER NOTE: USE AS PROBES IF NECESSARY:
1 VERY SOMEWHAT NOT AT ALL i
I I
- f. Can you identify dimeukies you have had as a resuk of a delay in an N1C nsponse to a licensing request?
- 1. yes
- 2. no 1
1 I
f1'.
IF YES: What were they?
i 11
- g. Has there ever been an impact on safety r=hl== from. delay in response to a licensing mquest?
- 1. yes
- 2. no l
gl. IF YES: Please discuss.
j
.,, w-The next series of questions deals with your knpressions of the various types of-.
communications you may have with NRC license reviewen.
- h. Have the nylewen been professional in their conduct? '
- 1. Yes, always
- 2. Yes, most of the tiene
- 3. Yes, somethnes
- 4. No bl. IF NO: Would you pavide examples.
m 1
4' 12
I -
1.
Have the h-reviewen been helpful?
- 1. Yes, always
- 2. Yes, most of the time
- 3. Yes, saatetimes
- 4. No
- 11. Can you give an example?
a.
u?...:z.:.
...m J.
Have the reviewen asked clear questions?.
1
}
l
- 1. Yegn,.
2.No
- k. Have the reviewers asked reasoaable questions?
- 1. Yes
- 2. Ne.
lkl. IF NO: would you give examples?
-d l
l 1.
Are there cases of which you are aware, in which reviewers have asked for Irrelevant infonnation?
l
- 1. yes i
- 2. no l
l 11. IF YES: Would you provide' examples?
l i
S 13
- l l
6 h
- m. What is your view of the technical compe'tence of NRC license reviewers?
l
- n. Do you believe their knowledge of your licensed activity or operation is q
adequate for them to do theirjob?
~ --- - -- --
- tr yer
~"~
- 2. no; C.
.A..
- o. In your opinion has a license reviewer ever imposed a personal rather than an agency laterpeitation of a regulation on you?
l
- 1. yes
- 2. no lo1. IF YES: PLEASE EXPLAIN.
- p. If you disagree with a license reviewer's position on an issue, do you know -
how to appeal up the NRC management chain?
- 1. yes
- 2. no pl. Do you feel free to do this?
- 1. yes
- 2. no lp2.
IF NO: Why is that?
d 4
14 y
y
,m, r
r-e
[-
- q. Do you feel the NRC's licensing process has improved, declined er stayed about the same over the past five years?
- 1. Improved
- 2. declined
- 3. stayed the same s
4~
.....<es.
w+
j l
q1. Why is that?
l l-
- r. If you could make one change in the licensing process, what would it be? -
. j l
SECTION IIL INSPECTIOM5'
~
The purpose of this part of the survey is to determine how effectively and efficiently the
~
NRC conducts its inspection activities.
- a. How familiar (knowledgeable) are you with the NRC's inspection process?
- 1. Very familiar ( knowledgeable)
- 2. Somewhat familiar (knowledgeable)
- 3. Not familiar (knowledgeable) i 4 '.
The next set of questions is designed to detennine your overall impressions.of the NRC inspecton who rwAine.ly inspect your facility.
- b. Are the inspecton professional in their dealings with you?
- 1. Yes, most of the time
- 2. Yes, some of the time
- 3. No 15
- c. Are the inspectoes knowledgeable of NRC regulations and your license conditions?
- 1. yes
- 2. no cl. IF YES: SKIP.TO, QUESTION E l
IF NO; CONTINUE
- d. De the inspectors ask questloem that show ignoranee of beshh physics, material control and accennting, physical security, or fundamental scientific or enal-ring principles? ~ ~
- 1. Yes
- 2. No
- e. Do the inspectors prtnride helpful information?
l
- 1. Usually
- 2. Somethnes I
- 3. Never f.
Do the inspectors have sufficient knowledge of your operation or institution to do their job adequately?
- 1. Yes
- 2. No
- g. Do the inspectors focus on the correct safety issues?
- 1. Yes
- 2. No
.i 16
- h. Do the LWen use their time effectively and efficiently at your l '
l facility?
l l
- 1. Usually
- 2. wi-
- 3. Never
~
1 I
1.
Would you provide snaurexamples of how thef die their time?
- w. n u,
.w
.e
.6 e+.
l L
- j. In your opinion, is there an area or anas of inspection that we could cut that' would have little or no enact on safety or safeguasding afgaur amaterial?-
- 1. Yes i
- 2. No
~.
l
- 11. IF YES: What are they?
- k. Are there areas thesesbeing ignored by inspecton that you believe are i
important to safety (to'Tafeguards)?
l l
l
- 1. Yes
-l L
- 2. No l
l kl. IF YES: What are they?
l l
s.
17
1.
Would you describe the impact of an inspection on ongoing activities INTERVIEWER NOTE: PROBE IF NECESFARY, USING THE FOLLOWING CONCEPTS:
FINANCIAL
... _ y - ---..-.... -
PRODUCTION / OPERATIONS 1
- m. When an inspector exits your facility, do you believe you receive a clear understanding of his/her findings?
- 1. Usually
- 2. Sometimes
- 3. Never 0
l ml. IF SOMETIMES OR NEVER: Why is that?
- n. Has an inspector ever imposed or attempted to impose on you what you believed to be a personal laterpretation of a regulation instead of an agency Interpretation?
- 1. Yes i
- 2. No 4
l nl. IF YES: Flense explain.
e 18
a o
j l
i
- o. Have LP ons provided you with infortnation ofvalue?
- ~,.. -......
l
- 1. Usually
)
- 2. Sometimes
- 3. Never i
1
-u n..
. - ~ ~.
lpl. IF SOM2,1IMF5 OR NEVt.n! Why is that?
/
- q. In the past several years what were the most safety signiim findings?
- r. If you disagree with an inspector's findings or an interpretation of requirement do you know how to appeal to NRC management?
- 'i
- 1. Yes'
- 2. No i
l rl. IF YES: Do you feel free to appeal a finding?
I
\\
\\
- s. Have you ever met an inspector's supervisor or manager at yo 1
1
- 1. Yes
- 2. No When were they here, and whrt were the cimi=ctances of their s1. IF YES:
19
5
- t. Have you observed changes in the NRC inspection process over the past five years?
- 1. Yes
- 2. No t
tlr=1PTE9r-6 theese_,_ -
j
- aaw
-e. % w
= u-
- u. The NRC has conducted team inspections with EPA and OSHA during the past several years. What is your impression of the utility of such an approach?
- 1. Very useful
- 2. Somewhat useful
- 3. Not very useful 9
ul. IF SOMEWHA.T OR NOT VERY USEFUL: Why is that?
V. If you could change one thing about the NRC 1=_W!on process, what would you change?
SECTION IV. REPORTING REQUIREMENTS The purpose of these questions is to determine your views regarding the overall regulatory efliectiveness of NRC reporting requistments, and your perceptions regarding any burdens which they may impose.
20
s;- What is your levet of understanding of the NRC reporting requirements e
, relevant,to your license,?
- 1. very high
- 2. moderate i
- 3. Iow i
- b. In your view, are there reporting nquirements which are excessive?
l
- 1. Yes
- 2. No
)
lbl.IF ES: Which are they?
i
- c. Have you ever been eked by the NRC.for falung to maaka a required report?
l
- 1. Yes l
- 2. No l
l l el IF YES: Please describe the circumerancam-i i
i
- d. Have you ever been ched because of a misinterpretation of what needs to be reported, or the manner and thne in which k need be reported (eg. telephone reports vs wrkten reports)?
- 1. yes
- 2. no 21
- e. When you make a telephone report to the NRC, are you treated courteously
)
and profesionally.
\\
- 1. All of the time
- 2. Some of the time w.
., - u,e, m,.
- 3. None of the thas,.
1 IF SOME OF TEE TIMf OR NONE 'OF THE TIME: Cosid'you' provide el.
i more specifics?
l I
Over the past severni years, your facility has.%tf [use h from background information provided] or [a number of] significant events to the t
NRC.
~
- f. How would you descdbe the NRC response to these events?
]
1 INTERVIEWER PROBE: RESPONSE APPROPRIATE j
4 NRC OVERREACTED NRC.UNDERREACTED l
- g. Was the additionalinformation requested reasonable?
- 1. Yes l
- 2. No, it was excessive.
i i
- h. 'Ihlaklag about the routine reports that you make, are there some that are l
particularly costly or burdensome?
i
- 1. ye 2.no bl. IF YES: Please provide their names.
i i
i 22 I
4
a
-o_
.:..a w
.; ns.
.s.v
~ n x
- i. Do you feel thatthere are reports which the h1C makes little or no use of?
- 1. Yes t
2.No i
i P
l 11. IF YES: Which are they?
i 12.. Why is that?
t J. Art there any reports for which feedback from the h1C has resulted in your l
being able to enhance system effectiveness or reduce your operating costs?
i
- 1. Yes
- 2. No r
f l jl. IF YES: Which art they?
t
- k. Art there changes you would recommend in NRC reporting requirements?
- 1. Yes
- 2. No kl.IF YES: What are they?
k2. What is the basis for your view?
23
1 A
1 SECTION V. ENFORCEMNT AND INVESTIGATIONS.:
'Ibe purpose of this section of the questionnaire is to determine the effectiveness of the NRC's enforcement process in promoting safety and safeguards.
- a. IIow knowledgeable are you of the NRC'!! Enforcemekt'Poucy?
.... w
..m -
......u
.,A,Rkno_wiedgeable_ _
- 2. Somewhat knowledgeable
- 3. Not very knowledgeable
- b. Have you had the opportunity to read Appendix C, of 10CFR Part 2?
i
- 1. Yes i
- 2. No
~
l IF YES, CONTINUE.
I l IF NO: SKIP TO QUESTION D.
- c. We are looking for your view's regarding the appropriateness of the severity-levels given in Appendix C as they relate to your facility.
- 1. Bey are very appropriate
- 2. Dey apply somewhat
- 3. They are not appropriate for my facility cl. IF SOMEWHAT OR NOT APPROPRIATE ASK: Why is that?
24 9
3
i
.gnve you ever been involved in escalated enforcement?
1.yes 1
2.no i
)
IF YES, CONTINUE.
j IF fid:' SKIP TO QUESTION E.
i
- l. What was the purpose of the enfortement conference?
1 1
l
- 11. Was the enforcement conference useful to you?
- 1. yes
- 2. no I
Why was that?
111. Were the issues clearly communicated?
- 1. Yes
- 2. No Why was that?
iv Was the final enforcement action timely?
- 1. Yes
- 2. No 25 l
l y-
t.
t l
IF NO: Why was that?
I a
1
- v. Was the process for subadtting an appeal clear to you?-
w
.,,v.
~
l 1, ya
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..r
..mn w
-n..-
- 2. No ' ' ? - -
e '- -
vi. Do you believe the basis of the NRC's final enferr4*wat* cision was clearly communicatedt" --
- 1. Yes
- 2. No
.1 vii. What is your view of an enforcement conference open to public observation?
~
i l
1 l
- e. In your view, how does the NRC enfore process contribute to overall nuclear safety and to the safeguarding of nuclear materials?
~l d
1
- f. Do you believe you need the services of a legal specialist in nuclear regulation and law if you an involved in potential escalated enforcement action with the NRC?
- 1. Yes l
- 2. No l
IF YES: Why is that?
1
~
- g. Are there any changes you would recommend be made in the enforcement
- l 26
'l 1
0 process?
r THE NEXT 5 QUESTIONS DEAI; WITH YOUR~ IMPRESSIONS OF ISSUES RELATING TO THE NR..C. 'S OFFICE OF.I..NVES. TIGAT..,I.O...N...S (O.. D. -
e of f.1.lisations ever conducted an. inv..estigE.tT.o..n at your
- h. Has.th.e dffic...e o
ave
- ...t
- 1. Yes
- 2. No
- u..
.x.
IF NO, SKIP TO SECTION VI. (FEES)
I l
IF YES, CONTINUE:
l West their activities conducted profendonally?
I.
- 1. Yes
- 2. No l
IF NO: Please explain.
J.
Was the outcome of the investigation conununicated to you?
- 1. Yes
{
2.No i
k.
Do you feel the results were conununicated in a timely manner? -
j
- 1. Yes I
- 2. No 27
=. -
=
r i'
,l kl. F NO: Why was that? ~
.e t
r 1.
What changes would you reconunend in the lavestigation process?
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, - se 4 dwr.kJ.mmaspie -,
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,,,,,2, SECTION VI. FEES l
~
- a. Are you aware of the basis and reasons for imposing fees on 11censees?
- 1. Yes
~
- 2. No e
t b.- Has there been an inspect on your activities due4a tae kapasition of fees?
i
- 1. Yes 2.No i
I F YES: Please describe in detail?
-l
- c. Have you cut any activities because of the kapasition of fees?
- 1. Yes
- 2. No cl. F YES: What wm they?
i I c2. E YES: We any of them safety related.
i l
1 28 F
h k
I
l
- d. If you feelaJee.idK.is inaccurate do you.know whom to contact to correct it?
i l
THANK YOU FOR'Yb R COOPERATION. THE RESUL'IS OF THIS SURVEY l
WILL BE USED TO PROVIDE THE BASIS FOR A DECISION ABOUT THE I
UTILITY OF ADMINISTERING THIS QUESTIONNAIRE TO A SAMPLE OF NRC LICENSEES.
i 1
i 1
l
)
i I
k i
i 29
+n,
on: Bemem, M f
"*4 UNITED STATES Cys: Taylor y;s
'*?
NUCLE AR REGULATORY COMMISSION y
W ASH IN GTON, D.C. 20555 j
Blaha (v
/
Scroggins, OC
- +*
May 28, 1992 OFFICE OF THE O'
SECRETARY I
MEMORANDUM FOR:
James M. Taylor Executive Director for ODerations p T FROM:
Samuel J. Chilk, Secretag(
I: PACT SURVEY FOR SECY-92-166-REGULATORY}LCENSEES SUILTECT:
FUEL CYCLE AND MATERIALS l
The Commission (with all Commissioners agreeing) has approved the staff proposal to implement the regulatory impact survey in a phased approach beginning with the fuel cycle and large materials facilities.
The staff should proceed with phase 1 as described in the subject SECY paper and, upon completion, provide the Commission with an evaluation of the results and a recommendation as to whether or not to continue with phases 2 and 3.
FEDO.) (NMSS)
(SECY Suspense:
2/26/93) 9100243 (EDO Suspense:
2/19/93) f cc:
The Chairman i
Commissioner Rogers Commissioner Curtiss Commissioner Remick Commissioner de Planque OGC OCAA OIG i
SECY NOTE:
THIS SRM, SECY-92-166, AND THE VOTE SHEETS OF ALL COMMISSIONERS WILL BE MADE PUBLICLY AVAILABLE 10 WORKING DAYS FROM THE DATE OF THIS SRM 1
ACTION - Bernero, NMS$
UNITED STATES Cys:
Taylor Blaha
[#
NUCLEAR REGULATORY COMMISSION Sniezek Knubel
/
3 Thompson W ASHIN GT ON. D.C. 20555 "o,
IN RESPONSE, PLEASE
,o January 15, 1993 REFER TO:
M921113A OFFICE OF THE SECRETARY MEMORANDUM FOR:
James M. Taylor Executive Director for Opi,tions D
FROM:
Samuel J.
Chilk, Secretar r
SUBJECT:
STAFF REQUIREMENTS - BRIEFKNG ON PROPOSED METHOD FOR REGULATING MAJOM MATERIALS LICENSEES (SECY-92-337), 10:00 A.M.,
- FRIDAY, NOVEMBER'13, 1992, COMMISSIOEERS' CONFERENCE ROOM, ONE WHITE FLINT NORTH, ROCKVILLE, MARYLAND (OPEN TO PUBLIC ATTENDANCE) and SECY-92-337 - RESPONSE TO RECOMMENDATIONS OF THE MATERIALS REGULATORY REVIEW TASK FORCE The Commission was briefed by the NRC staff on the proposed method for regulating major materials licensees.
As a result of-the briefing and the staff racc=nendations in SECY-92-337, the details of staff's proposed plan should be reconsidered to incorporate the following comments:
A.
The Commission believes that, to achieve the staff's goal of improved safety, the highest priority should be to sharpen and upgrade the regulatory basis for determining the adequacy of licensee performance.
The Commission also is concerned that the plan as presented by the staff places too much emphasis on team assessments in advance of clearly defining an appropriate regulatory basis.
Accordingly, in the near term, the Commission would like the staff to focus its efforts on those activities in the proposed plan to upgrading and more clearly defining the tory basis for regulating major materials M = mees, deferring team assessments until staff
% ides the Commission with an analysis of team assessments and alternatives.
Alternatives should include but need not be limited to enhancing inspections, use of workshops with licensees, staff working with licensees or a licensee organization to establish a self-assessment program or a solicitation SECY NOTE:
THIS SRM, SECY-92-337, AND THE VOTE SHEETS OF ALL COMMISSIONERS WILL BE MADE PUBLICLY _AVAILABLE 10 WORKING DAYS FROM THE DATE OF THIS SRM
/ of volunteers for conducting a self-assessment or having an NRC team assessment conducted.
The analysis should also include input from the results of the regulatory impact survey and previous licensee workshops.
As this process of upgrading the regulations goes forward, staff should evaluate existing and proposed regulations with an eye towards identifying and deleting unnecessary requirements.
Finally, the Commission is of th's view that, where possible, consideration should be given to the use of performance-based regulations.
B.
The staff should place greater emphasis on regular licensee workshops that focus on specific topics, such as developing a clear understanding of the scope of integrated safety assessments.
C.
Staff should clearly define the purpose and provide preliminary guidance to licensees on the content of an i
integrated safety assessment (ISA).
This should be done in consultation with licensees.
These activities should be completed prior to asking licensees to prepare and submit ISAs.
In this context, staff should l
explore whether it is feasible and cost-effective for the risk-analysis component of the ISA to include quantitative estimates of the probabilities of
)
potentially high-consequence accident sequences or whether qualitative estimates would suffice.
i Additionally, staff should ensure consistency in terminology between offices (i.e. NMSS and NRR) as work progresses on the development of guidance and the definition of NRC expectations for licensees in performing ISAs.
j D.
The license renewal process for major fuel cycle licensees should be carefully considered and factored into the staff's final action plan.
The license renewal process should be replicable, defensible and efficient.
The process should be-predictable and i
generally constitute a reconfirmation that licensee operations are in conformance with NRC requirements, as opposed to a comprehensive de novo examination of facility safety.
To the extent that it can contribute to assuring that safety requirements are implemented on a more continuous basis, rather than at the time of license renewal, the action plan should be refined.
' E.
Staff and industry should be encouraged to seek out and identify practices, procedures and standards used by other industries (e,q, the petrochemical industry) to manage the safety and environmental hazards associated i
with the production and use of industrial chemicals for possible application to NRC licensees.
In this regard, some type of industry group oversight, comparable to the role that INPO performs for power reactor licensees, might be useful for the major materials facilities.
Recognizing _that there may be some unique barriers to such an arrangement in this area, the benefits of such an approach merit evaluation.
To the extent such a group could be developed, it could reduce the scope and frequency of staff team assessments that would otherwise be needed to assure safe operations.
j F.
Finally, while many of the activities discussed in the staff action plan are applicable to facilities which are primarily of regulatory concern to the NRC, the approaches may also be applicable to other types of licensees regulated by the Agreement States.
The staff should keep the Agreement States informed of the plan.
j i
G.
The staff, prior to development of a program for periodic licenses evaluation by NRC as described in the Staff Action Plan (Section 5.2.8
" Licensee Evaluations"), should determine if this type of program is necessary or even feasible considering the diverse nature of the licensees involved.
If this type of program is necessary, careful consideration should be given to the lessons learned, both pros and cons, from the current SALP process used for reactors.
The staff should.brief the Commission in the March timeframe on the status of its reconsideration and incorporation of the above comments as well as the plan's impact on resources.
Thereafter, the Commission should receive annual briefings on the progress of these activities.
(EDet (WGS)
(SECY Suspense:
3/19/93) 9300005 Additionally, the staff should monitor developments concerning the potential use of Former Soviet Union HEU in U.S.
facilities
~and keep the Commission informed of any needs to amend plan priorities in this area, including the safeguards area. (NMSS) 9300006 s
p cc:
The Chairman Commissioner Rogers Commissioner Curtiss Commissioner Remick Commissioner de Planque
~
OGC OIG Office Directors, Regions, ACRS, ACNW (via E-Mail)
OP, SDBU/CR, ASLBP (via FAX)
,-