ML19308B984
| ML19308B984 | |
| Person / Time | |
|---|---|
| Site: | Crane  |
| Issue date: | 01/17/1980 |
| From: | GENERAL ACCOUNTING OFFICE |
| To: | |
| Shared Package | |
| ML19308B982 | List: |
| References | |
| TASK-TF, TASK-TMR EMD-79-16, NUDOCS 8001170725 | |
| Download: ML19308B984 (26) | |
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7 REPORTING UNSCHEDULED EVENTS GENERAL ACCOUNTING OFFICE AT COMMERCIAL NUCLEAR REPORT TO THE CHAIRMAN, FACILITIES:
OPPORTUNITIES NUCLEAR REGULATORY COMMISSION TO IMPROVE NUCLEAR REGULATORY COMMISSION OVERSIGHT
_D _I _G _E _S _T
.The Nuclear Regulatory Commission regulates the construction and operation of nuclear powerplants and other facilities and the and disposal of nuclear possession, use, materials to protect the public from radia-To oversee these activities, tion hazards.
the Commission relies on information obtained in reports f rom licensees.
The Commission uses these reports to (1)-identify safety-related incidents and problems, (2) assist it in making safety-related decisions, and (3) disseminate information to the public on the nuclear industry's operating experi-ences.
Examples of safety-related incidents or events that licensees must report are over -
exposures of workers or the public to radia-tion and failures of instruments used to monitor various safety-related activities.
GAO reviewed the Commission's program for collecting and evaluating licensees' reports of incidents or unplanned events.
GAO found that the Commission needs to im-its licensee report assessment pro-prove cedures to better assure that it is identi-fying and acting on all safety-related prob-lems.
For example, the Commission's review of reported events following its discovery of a safety-related problem at two operating nuclear powerplants revealed that the prob-Bet-lem had been widespread for sometime.
'r ter assessment procedures may have enabled the Commission to identify this problem ear-lier.
(See pages~3 to 8.)
GAO also found that the Commission should extend its licensee report requirements to The Com-types of events not now covered.
mission should:
EMD-79-16 Tear Sheet. Upon removal, the report 800i170}g cover date should be noted hereon.
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--Require utilities operating older nuclear powerplants to monitor and report on the per formance of safety-related systems and 1
components in a manner consistent with re-quirements for utilities operating newer powerplants.
This would give the Commis-sion more complete information on unplanned events at operating nuclear powerplants.
(See pages 13 to 15.)
--Require licensees using hazardous types and quantities of nuclear ma.terials in conjunction with equipment such as radi-l ography devices to report equipment fail-ures which could cause or contribute to safety-related incidents.
The most sig-nificant occupational overe.posures occur in these types of nuclear p;ograms, but the Commission now receives equipment failure information only when safety-related incidents actually occur. (See pages 15 to 16.)
--Require medical licensees to report to the Commission misadministrations of radiation or radioactive materials to patients.
The Commission needs to be informed of these incidents so it can determine their causes and, if appropriate, alert other medical licensees of the hazards associated with certain operating practices and modify its medical licenses or regulations.
(See-pages 16 to 18.)
This report also addresses the President's request in his 1977 energy message that the Commission make mandatory a nuclear industry. _
voluntary system for reporting minor mishaps and component failures at nuclear powerplants.
The primary objective of this system is to develop a data base for industry so it can increase the reliability and performance of future plants through improved designs and operating practices.
Many utilities have not made meaningful efforts to participate in the system.
The Commission attributes this to uncertainty over the future of nu-q.
clear power.
At this time, the Commission is not convinced of the need to mandate full industry participation because it does not believe any major nuclear powerplant ii
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design improvements would result.
The Commission intends to study the issue further while increasing its financial support to the system.
(See pages 8 to 10.)
At this time, GAO believes it unlikely that the Commission can justify mandatory indus-try participation in the reporting system when factors such as additional industry costs, limited expected safety benefits, and duplication with the Commission's event report system are considered.
GAO does, however, believe a full examination of the issue is warranted.
An alternative approach to continued Commission staf f study, which GAO favors, would be to decide the issue in the near future using rulemaking procedures.
This format would best insure that the Com-mission obtains and considers the views of the nuclear industry and the public in reach-ing its decision.
At a minimum, the Commis-sion should address
--the objectives, benefits, and costs of a mandatory reliability report system;
--responsibility ~for funding and operating a mandatcry reliability report system; and
--the reliability report system's interface with the Commission's present reporting requirements.
GAO RECOMMENDATIONS To provide the Commission with reasonable assurance that it promptly identifies all safety-related problems from licensee event and/or incident reports, the Chairman, Nu-clear Regulatory Commission, should:
--define the scope and frequency of required
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j analyses, and documentation and disposition procedures, for staff use in assessing li-censee event reports; and j
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--establish a system for controlling and j
evaluating incident reports with clearly j
1 defined objectives, responsibilities, requirements for analyses, and adminis-trative procedures.
(See pages 3 to 12.)
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In addition, the Chairman, Nuclear Regulatory Commission, should extend its event and in-cident reporting requirements to require
--uniform surveillance and reporting re-
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guirements on safety systems and compo-nents common to all nuclear powerplants,
--nuclear materials licensees using equip-ment containing hazardous radioactive materials to report equipment design de-ficiencies and malfunctions, and
--medical licensees to report all misadmin-i istrations of patient radiation treatments and radioactive drugs.
(See pages 13 to 20.)
GAO also believes that.the Chairman, Nuclear Regulatory Commission, should use rulemaking procedures to decide the issue of mandating full nuclear industry participation in the industry's voluntary reliability report system.
(See pages 8 to 11.)
COMMISSION STAFF VIEWS The Commission's staff agreed that it should improve its controls over and reviews of licensee event and incident reports.
The staff also agreed on the need to promptly resolve the issue of mandating industry participation in its voluntary reporting system.
The staff suggested advance notice of proposed rulemaking as an appropriate method for resolving this issue.
The staff did not agree that the Commission should
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require uniform surveillance and reporting on all operating nuclear powerplants, or require medical licensees to report all misadministrations.
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C_o n t e n t s fagg DIGEST i
CIIAPTER
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1 INTRODUCTION 1
Scope of review 2
2 LICENSEE REPORTS SHOULD BE USED MORE 3
EFFECTIVELY NRC needs to better manage reports of events at operating nuclear powerplants 3
NRC needs to systematically account for and evaluate nuclear material licensee incident reports 6
Mandatory industry reliability system participation may not be necessary 8
Conclusions 11 Recommendations 12 NRC staff views 12 3
NRC SilOULD EXTEND CERTAIN REPORTING REQUIREMENTS TO LICENSEES NOT NOW INCLUDED 13 Need for uniformity in nuclear powerplant reporting 13 NRC does not require materials licensees to report equipment failures 15 NRC does not require medical licensees to report misad-ministrations 16 Conclusions 18 Recommendations 20 NRC staff views 21 ABBREVIATIONS AEC Atomic Energy Commission FDA Food and Drug Administration GAO General Accounting Office ~
NRC Nuclear Regulatory Commission 1
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CHAPTER 1 INTRODUCTION The Nuclear Regulatory Commission (NRC) regulates the possession, use, and disposal of nuclear materials to protect the public from radiation hazards.
There are presently about 8,800 NRC-issued licenses. 1/
Included in this figure are op-erating licenses for 69 nuclear powerplants and construction permits for 89 more.
Thirty-three licenses are for nuclear fuel cycle facilities, 73 are for research and test. reactors, and the remaining licenses are for various research, indus-trial, medical, and educational applications of nuclear mate-rials.
To oversee such a large and diverse number of activities, NRC relies to a great extent on information f rom licensees to assist it in making safety-related decisions concerning all aspects of the possession, use, and disposal of nuclear mate-rials.
Information supplied by licensees often becomes the basis for regulations and standards by which licensees are regulated.
Because it needs this information, NRC has estab-lished general licensee reporting requirements in its regu-lations and sets more specific requirements in individual licenses.
NRC's regulations require all licensees to report radio-active material releases and radiation exposures to individ-uals in excess of regulatory limits; and to report the loss or theft of nuclear materials.
The regulations also contain many other reporting requirements directed at specific types of licensees.
NRC uses these reports to assess licensees' day-to-day I
operations.
In this way, NRC tries to identify and investi-gate incidents and problems, assure corrective actions, devel-op information on generic problems, and disseminate information to the public concerning the nuclear industry's operating ex-periences.
In addition, the Energy Reorganization Act of 1974 (42 U.S.C. 5848) requires NRC to investigate unplanned or un-anticipated incidents and report significant safety-related 9
1/Also, 25 States have signed agreements with NRC to regulate about 11,000 additional nuclear materials licenses.
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events--abnormal occurrences 1/--to the Congress and the public on a quarterly basis.
These reports must also state the causes and the corrective actions taken to prevent recurrence.
SCOPE OF_ REVIEW We reviewed NRC's program for collecting and evaluating t
licensees' reports of unscheduled events or incidents.
These events are unplanned and usually are related to safety.
Ex-amples include overexposures of workers or the public to radi-ation, failures of systems that may permit overexposures or excessive releases of radiation, or failures of critical in-I struments used to monitor important systems.
We did not re-view NRC's periodic or routine reports such as annual or quarterly occupational exposure reports, routine effluent monitoring reports, and notifications of nuclear material transfer.
Our report addresses
--the efficiency and effectiveness of the entire incident report system,
--whether or not the system is broad enough in coverage, and
--the President's request that NRC make mandatory a nu-clear industry voluntary system for reporting minor' mishaps and component failures at nuclear powerplants.
The report also contains our conclusions, observations, and recommendations on these matters.
v 1/NRC has established specific criteria for determining which unscheduled safety-related events should be classified and reported as abnormal occurrences.
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CHAPTER 2 LICENSEE REPORTS SHOULD BE USED MORE EFFECTIVELY NRC requires licensees tb report incidents and
--i unplanned events associated with the construction and opera-tion of nuclear powerplants and the use of nuclear materials.
NRC has identified safety-related problems by assessing these is More ef fective use of these reports, however,
reports.
hampered by a lack of clearly defined assessment objectives As and methods, responsibilities, and procedural controls.
a result NRC does not know if it is promptly finding and iden-Furthermore, tifying all potential safety-related problems.
its report review procedures are fragmented.
Finally, it cannot be certain it has received and appropriately reviewed all reports.
NRC also encourages utilities operating nuclear power-plants to participate in a nuclear industry system for vol-untarily reporting minor mishaps and component failures at these plants in order to develop a reliable data base for NRC and industry to use in improving powerplant designs and The President has asked NRC to mandate operating practices.
full nuclear industry participation in this reliability re-if the benefits from por t system; but NRC has not yet decided a mandatory industry participation program outweigh the addi-tional industry reporting burden--especially in view of the present duplication between the voluntary reliability report system and NRC's licensee event report system.
We suggest that NRC consider resolving this question by means of rule.
making procedures.
NFC NEEDS TO BETTER MANAGE REPORTS OF EVENTS AT OPERATING NUCLEAR POWERPLANTS NRC has established an extensive reporting system--called a licensee event report system--to gather information on the f
operating experience at nuclear powerplants.
During 1977 util-
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ities submitted about 3,000 reports to NRC describing inci-3 dents and unplanned events at powerplants.
Depending on their the safety significance, utilities are required to report events immediately, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, or within 30 days of their occurrence.
Immediate or 24-hour reports are required for important events such as excessive releases of radiation, overexposures to individuals, or attempted sabotage.
Utilities must report l
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f these events by telephone or other means of rapid communication to the nearest of NRC's five regional inspection and enforce-ment offices.
Based on these notifications, NRC regional of-fices take action on a case-by-case basis in accordance with established response procedure.s.
Detailed written follow-up reports must also be submitt'ed within 14 days.
The 30-day re-ports submitted to NRC regional offices usually involve equip-ment failures during tests, utility failures to perform re-
.guired surveillances, or inadequate procedures.
NRC regional offices forward report copies to an NRC i
headguarters distribution office set up in February 1978 to account for all licensee event reports and route them to ap-propriate staff offices.
Before this, NRC had no assurance that it was receiving and properly distributing all reports.
It is still too early to determine if tt is of fice will be able to account for all reports.
The distri' Jtion of fice sends re-port copies to the headquarters Of fice of Inspection and En-forcement, Division of Operating Reactors (in NRC's Of fice of Nuclear Reactor Regulation), and Office of Management and Pro-gram Analysis.
At NRC regional offices, inspectors are required to assess each licensee event report for (1) the appropriateness of li-censee corrective action and the need for a follow'-up ins'pec-tion effort; (2) the event's generic importance to other compo-nents, systems, or activities within the powerplant or at other powerplants in the region; and (3) possible reporting to the Congress as an abnormal occurrence.
Staffs of the three NRC headquarters offices assess each report for its safety impor-tance at the powerplant, its applicability to all other power-plants, and its potential for reporting as an abnormal occur-An important part of this assessment is the identifica-rence.
I tion of potential safety-related problems needing further evaluation and perhaps action in the form of new regulatory requirements.
NRC has clearly defined staff and Commission responsibil-
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ities, administrative procedures, and assessment criteria for identifying events at operating nuclear powerplants and other licensed activities which must be reported to the Congress as an' abnormal occurrence.
It has not, however, clearly defined these assessment elements for identifying potential safety-related problems f rom licensee event reports.
Rather, it has lef t to each of 'the three headquarters of fices and five re-gional of fices the discretion of decidino on the scope and frequency of analyses necessary to identify new safety prob-lems as early as possible.
The offices have further delegated l
this decisionmaking to individual staf f members.
Furthermore, neither NRC as a whole nor its respective staff offices has established decision documentation and disposition procedures.
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r Thus, only when a new safety problem is identified can NRC be assured that the repor t or series of reports has received an adequate assessment.
In the past, NRC has identified certain safety-related problems at operating nuclear powerplants using the fragmented
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NRC officials said these problems were usually discovered through the cooperative ef forts of utilities, powerplant component manufacturers, and the NRC staff.
Most of these problems, they said, were originally de-scribed in licensee event reports.
By querying NRC's comput-orized file of event reports, NRC staff members were then able to determine that these problems were widespread and signifi-cant enough to warrant additional investigation.
We believe o more systematic assessment process in which analytical and procedural requirements are clearly defined would give NRC better assurance that it is promptly identifying all safety-related problems.
For example, one problem now under NRC review deals with shock absorbers attached to piping in nuclear powerplants to prevent vibrations from cracking the pipes.
These shock ab-sorbers are filled with fluid and must retain this fluid to remain effective.
In 1973 an NRC inspection of two operating powerplants revealed a high incidence of inoperable shock ab-sorbers.
The regional inspection office pointed out the prob-lem to NRC headquarters of ficials.
These officials then re-viewed NRC's file of licensee reports and found that the problem had been widespread for some time.
Its initial inves-tigation revealed problems related to inadequate materials.
Further investigation revealed still other problems including design, manufacture, and installation deficiencies.
This example highlights the need for NRC to clearly de-fine the scope and frequency of analysis required to promptly identify potential safety-related problems.
Had such require-i ments been in effect, NRC may have detected the shock absorber problems earlier.
We are not alone in our concern that NRC is not making full and effective use of its licensee event re-port system.
Recently, members of the Advisory Committee on c.
Reactor Safeguards 1/ expressed concern that the NRC staff is P
not adeguately using data collected from reports because the otaff has not, in the Committee members' opinions, set up a cystematic methodology for using this data.
Members of the l
NRC staff have also recognized shortcomings in the system.
1/Au independent committee of up to 15 members established by the Congress.
It is reouired to review each nuclear power-plant application and make other reviews as requested.
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For example, in an evaluation of licensee reporting the technical advisor to NRC's Executive Di-requirements, rector for Operations concluded that NRC should be obtaining, analyzing, and feeding back nuclear powerplant operating data into the licensing process much better than it is now doing.
NRC NEEDS TO SYSTEMATICALLY ACCOUNT FOR AND EVALUATE SUCLEAR MAT 5 RIAL L'lCENSEE
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INCIDENT REPORTS Significant nuclear-related incidents, such as overexpo-sures to workers or members of the public, occur more of ten at nuclear material licensee f acilities than at operating nu-clear powerplants.
In part, this is due to the comparatively large number--over 8,000--of nuclear material licensees.
NRC requires these licensees to report radiation exposures or ra-dioactive material releases in excess of limits established in its regulations; and the loss or thef t of nuclear materials.
These licensees report about 300 incidents annually.
Officials of several NRC offices said they use these reports as follows:
--regional inspection offices use them in determining the causes of incidents and evaluating licensees' corrective actions;
--the Office of Inspection and Enforcement uses them in evaluating NRC's inspection and enforcement program and to identify potential abnormal occurrences;
--the Of fice of Nuclear Material Safety and Safeguards uses them in determining if specific license conditions or general licensing policies and standards need im-provement, and to identify safety problems that could be common to other licensees; and
--the Office of Management and Program Analysis uses them to prepare NRC reports and to identify potential abnor-
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mal occurrences.
NRC has not, however, established a system for controlling licensee reports to insure that each of fice receives and as-sesses all reports nor has it defined evaluation procedures and responsibilities of each of fice.
NRC does not account for incident reports NRC's regulations generally direct nuclear materIrl licensees to report incidents to the nearest NRC regional office.
NRC has not, however, set uo procedures to insure 6
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that regional offices forward incident reports to appropriate headquarters offices.
As a result, the NRC headquarters in-spection, licensing, and program analysis offices are not receiving all incident reports submitted by licensees to NRC regional offices.
The NRC headquarters offices rely heavily on regional inspection offices' telephone calls, daily activity reports, and license inspection reports as sources of information on licensee incidents.
But these have proved to be unreliable sources to identify incident reports.
For example, neither the NRC headquarters inspection, licensing, nor program analysis offices has a complete list of 23 overexposure in-cident reports submitted to one regional office in 1977.
In fact, the Office of Management and Program Analysis, which annually publishes a report on overexposure statistics, was aware of only 8 of the 23 overexposures.
NRC has not defined assessment procedures and resoonsibilities NRC has not established procedures for its offices to follow in assessing nuclear material licensee incident reports which would define review objectives and scope, office respon-sibilities, or coordination required among offices.
As a re-sult, there is some confusion among the various headquarters 1
and regional offices over the scope of assessments each office performs.
For example:
--NRC headquarters officials said they rely on regional office inspectors to identify from incident reports weaknesses in licensees' nuclear programs that might j
be common to other licensees.
Regional office inspec-j tors, however, said NRC headquarters should be respon-sible for this type of evaluation because it receives reports from all five regional offices.
--Two of the three regional offices we visited do not attempt to identify weaknesses in licensees' nuclear programs that might apply to other licensees.
On the other hand, the third office accords this its highest priority.
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--Officials of NRC's headquarters inspection office and its licensing office each said the other office is re-sponsible for maintaining a comp?ete file of incident reports.
As a result, neither office maintains a com-plete file.
--NRC's licensing office has not assigned staff review l'
and disposition responsibility for identifying safety l
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that might apply to other licensees.
Officials problems of this office could not provide us examples of any such safety problems identified from incident reports, nor could they provide any documentation to show the reviews were performed.
NRC's failure to define objectives, procedures, and respon-sibi,lities has resulted in incomplete incident assessments.
incident reports submitted to two regional offices For instance, are not reviewed by either regional or headquarters utaf f for dj.
the purpose of identifying safety problems which might apply to
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MANDATORY INDUSTRY RELIABILITY SYSTEM PARTICIPATION MAY NOT BE
_NECESSARY
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the President requested In his April 1977 energy message, NRC to make mandatory the present nuclear industry system for voluntarily reporting minor mishaps and component failures at operating nuclear powerplants.
It was expected that mandatory participation would enable industry and NRC to develop a more reliable data base of safety-related system and componentThe failures than attainable with voluntary participation.
reliability system was designed to produce system and component failure statistics from nuclear powerplant operating experience useful to NRC and those who design, construct, and operate these plants by
--improving -ystems reliability and increasing the time powerplants are on line,
--improving system designs and surveillance and test schedules,
--identifying failure trends and wear-out patt' erns,
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--reducing powerplant licensing times, and
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--improving maintenance and spare parts management and component purchasing evaluations.
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There are at least two important dif ferences between the industry's reliability report system and NRC's licensee event First, NRC requires reports of many other report system.
types of safety-related events besideo system or component failures.
Second, NRC's report system in primarily oriented towards opecating safety--NRC needs to be notified of events so it can investigate their public safety implications--and I
secondarily towards improving the reliability of powerplant systems and components.
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l Reliability system operation and funding i
The Edison Electric Institute developed the reliability l
system in the early 1970s at the suggestion of the Amer ican National Standards Institute.
In 1973 a contractor was selected to operate the system and the American National i
Standards Institute established a subcommittee to oversee the system's operation.
NRC was, and continues to be, repre-sented on this. subcommittee and in 1978 provided $150,000 I
of the system' contractor's $370,000' operating budget.
The remainder of the budget is provided by the Edison Electric Institute, the American Public Power Association, and the Tennessee Valley Authority.
Full system participation by a utility operating a nu-clear powerplant requires a one-time initial ef fort to develop engineering data on all safety-related components and systems.
In a typical nuclear powerplant there are dozens of safety-related systems and as many as 6,000 com-ponents.
Two to three man-years of effort at an estimated cost of $200,000 to $250,000 is necessary to develop the one-time engineering data.
The annual cost of reporting component and system failures is estimated at S50,000 per powerplant.
s Except for six of the oldest operating plants, all utilities operating nuclear powerplants are eligible to participate in the reliability system.
The six oldest plants were considered atypical and thus not included.
Utilities operating 55 of 58
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presently eligible plants are participating in the reliability system.
Two utilities have declined to participate, and an-other has not reported any system and component engineering data.
Many utilities, however, have limited their partici-pation.
While some utilities have completed their engineering data, others.have not put forth meaningful efforts.
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NRC estimated that utilities have submitted engineerlag data on about 65 percent of their plants' safety-related systems and components.
Furthermore, in reviewing the utilities' failure reports, NRC found many examples of poor and incomplete l
reporting.
For example, when it compared component failure-related licensee event reports to utilities' reliability system failure reports, NRC found that utilities reported only about 20 percent of the failures that they should have re-l ported in the reliability system.
NRC believes some utilities are not fully participating in the reliability system because the expected benefits are essentially long term and will be realized on future--rather than presently operating--nuclear powerplants; and these util-ities.do not presently plan to build additional nuclear plants.
Also, there has not been any ef for t to date to develop l
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in information with short-term usefulness reliability system spare parts management.
Finally, the relia-maintenance or includes only safety-related systems.and compo-bility system to There are many systems and components important nents.
powerplant operations which are not safety-related.
A major consideration on the issue of mandatory industry participation in the reliability system is its inter f ace with report system.
Presently, about 60 per-licensee event NRC's failures information utilities report on component cent of the On the in the reliability system is also reported to NRC.
other hand, because the two systems' objectives are dif ferent, each report system requires some information on component Furthermore, NBC requires failures not required by the other.
licensees to repor t many types of events besides system or failures--about 50 percent of the event reports component failures.
NRC receives relate to system or component NRC staff, industry, and other opinions on mandatory _ participation is presently no consensus within NRC to mandate There system.
industry participation in the reliability report In 1977 an NRC study group recommended mandatory participation, full but also concluded it would probably not result in any major nuclear powerplant design improvements.
An Advisory Committee on Reactor Safeguards subcommittee was not convince of the need for mandatory participation in view of (1) the costs, duplication with the NRC licensee event report system, (2) lack of systematic NRC staff analyses of licensee and (3) event reports.
The nuclear industry opposes NRC mandating industry par-the needs for and uses of compo-ticipation on the basis that reliability data go far beyond legitimate regulatory the reliability system was not de-nent needs.
They point out that industry signed to be a regulatory tool, and that by mandating participation NRC would essentially be taking over the system for regulatory purposes.
In August 1978 the principal NRC official addressing this issue told us that the NRC staff is preparing a paper for presentation to the NRC Commissioners which will recommend this industry participation not be made mandatory at time; that NRC study the issue further; and, in the meantime, that
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that NRC increase its financial support to the reliability report system in order to promote increased voluntary partici-I pation and use of the system, I
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_C_O_N_C_LU__S_I_ONS An important part of NRC's overall assessment of events l
reported by utilities operating nuclear powerplants is theide l
form of new reg-further evaluation and perhaps action in theNRC has identified some safety-relat l
l ulatory requirements.
Its present assessment reports.
problems from licensee eventsystem, however, is fragmented and in as four offices reviewing an event it is promptly find-Moreover, NRC does not have assurance thatidentifiable safety-related p not clearly defined the scope and frequency of required analy-ing all to the discretion of Instead, these matters are leftFinally, NRC has not established review ses.
individual reviewers.
and decision documentation and disposition procedures.
for nuclear material licen-Likewise, NRC cannot account reports to insure that they are all adequately (1) objectives and see incidentIt has not defined assessment (2) responsibilities; and (3) procedures assessed.
required analyses; insure that all reports are properly received,its assessments of
- routed, to Thus, as is the case for it is
' and evaluated.
licensee event reports, NRC cannot be assured that promptly identifying all safety problems from incident reports.
With respect to the industry's voluntary reliability re-port system, NRC is not convinced of the need for mandatingintends to continu It therefore full industry participation.
to studying the issue while increasing its financial supportit unlikely that NRC At this time, we believe can justify mandatory industry participation when factorsindustry costs the system.
such as additional report systems benefits, and duplication with NRC's event full examination believe a are considered.
We do, however, An alternative to continued in-of the issue is warranted.
issue house study, and one we favor, would be to decide the In a rule-in the near future using rulemaking procedures.
making proceeding, NRC sets out a proposed course of action,and invites pub and a timetable for implementing it, in deciding NRC then must consider comments receivedRulemaking in this case wou ment.
on a final course of action.
as well as the provide the nuclear industry and the public,the opportunity to get th and would better insure that all of these views are properly con-NRC staff, We believe this is sidered by HRC in deciding the issue.
particularly important since the reliability system was de-in-veloped, operated, and primarily funded by industry fora rulemaking proceed-dustry's--rather than NRC's--benefit.
i ing should, at a minimum, address r
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--the objectives of a mandatory reliability report system;
--the costs of mandatory industry participation and the expected benefits;.-
--the beneficiaries, and how they will benefit from mandatory industry participation;
--responsibility for funding and operating a mandatory reliability report system; and
--the reliability report system's interface with MRC's existing event report system and how the two systems could be operated or merged to minimize duplication.
RECOMMENDATIONS that it promptly To provide NRC with reasonable assurance identifies all safety-related problems from licensee event and/or incident reports, the Chairman, NRC, should
--define the scope and frequency of required analyses, and documentation and disposition procedures, for staff use in assessing licensee event reports; and
--establish a system fer controlling and evaluating inci-dent reports with clearly defined objectives, responsi-bilities, requirements for analyses, and administrative procedures.
We also recommend that the Chairman, NRC, resolve the is-sue of NRC mandating full nuclear industry participation in the reliability report system by using rulemaking procedures.
NRC STAFF VIEWS NRC's staff agreed that it should improve its controlsThe over and reviews of licensee event and incident reports.
NRC staff also agreed on the need to promptly resolve the is-sue of mandating industry participation in its voluntary re-The staff suggested advance notice of proposed porting system.
rulemaking as an appropriate method for resolving the issue.
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l CHAPTER 3 NRC SHOULD_ EXTEND CERTA.7N REPORTING REQUIREMENTS TO
. LICENSEES NOT NOW INCLUDED NRC's event-oriented reporting requirements are not sufficiently broad and should be extended to cover addi.tional licensees and types of events.
Specifically, NRC should require
--all utilities operating nuclear powerplant.s to report the same unscheduled events,
--nuclear materials licensees to report equipment failures which could cause or contribute to safety-related inci-dents, and
--medical licensees to report misadministrations 1/ of radiation or radioactive materials to patients.-
NE"D FOR UNIPORMITY IN NUCLEAR POWERPLANT REPORTING NRC's nuclear powerplant reporting requirements are much more comprehensive than for other types of licenses.
In 1977 utilities operating 64 powerplants reported about 3,000 events.
These included such things as small errors in instrumentation gauges, valve malfunctions, utility failures to make periodic surveillances, and inoperative emergency equipment.
The requirements for nuclear powerplant reporting are established in NRC's licensing process.
At that time a utility submits detailed information on the nuclear powerplant, includ-ing proposed operating limits for the plant's systems, NRC re-views the proposed operating limits and, if acceptable, approves them for licensing purposes.
This part of the license is re-ferred to as the " technical specifications" and becomes the re-quirements by which the utility must operate the plant.
The technical specifications also describe what deviations from c
these operating limits must be reported to NRC.
Utilities 1/ Error in administering a radioactive drug or radiation treat-ment to a patient, including (1) the wrong drug or radiation treatment source, (2) the wrong patient, or (3) a dose or j
method of administration other than prescribed.
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i, report any overexposures of individuals to radiation also must and excessive releases of radiation.
its present reporting system, NRC does not require This is attributable Under all licensees to report the same events.NRC's technical specification re-to two developments.
- First, Thus, guirements have historically become more stringent. utilities oper surveillances, make more tests, and consequently may report more deviations on the same components and systems than utili-For example, NRC officials told ties operating older plants.
us that surveillance requirements for reactor cooling waterthan those of an a new plant are much more stringent Therefore, these pumps at older plant with the same type of pumps.
is required a utility operating a newer plant officials said, to report certain pump failures which a utility operating an older plant is not required to report.
new plants which us'e more sophisticated equipment
- Second, and have more systems than older plants consequently have more This in turn results in increased surveillance requirements. For example, an NRC comparison of a deviations and reporting.
nuclear powerplant licensed to operate in 1970 and another the utility operating the older licensed in 1977 showed that plant was required to make 13,633 annual surveillances compared annual surveillances for the utility operating the Each time a surveillance is made and an excessive to 169,216 deviation noted, the utility must report the deviation to NRC.
newer plant.
The ef fects of both the more stringent licensing review and the additional surveillance requirements at new plants as opposed to old plants are further demonstrated by comparing the number of reports submitted to NRC by all utilities operating nuclearUtilities s powerplants during 1977.
42 reports for plants reports on plants licensed before 1970, licensed between 1970 and 1975, and 99 reports for plants li-Two utilities operating plants licensed before censed in 1976.
1964 did not submit any reports.
is presently standardizing technical specifications How-NRC future plants and some plants under construction.
ever, NRC of ficials said this would not affect nuclear power-for plants now operating because NRC will not require ut c,
NRC's stated purpose of the licensee event report system identify and correct safety problems at existing and If reporting requirements for all plants are is to the same for essentially the same systems and components, future plants.
complete information on the nature not NRC may not be receiving and frequency of unscheduled events at operating nuclear powerplants.
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We find it paradoxical that NRC imposes its most i
stringent surveillance and reporting requirements on utilities operating newer powerplants.
These newer plants incorporate the latest technological improvements and NRC safety require-ments and presumably are safer to operate than older gener-ation plants.
It seems, therefore, that the more stringent requirements for newer powerplants should logically also fall on the older powerplants.
NRC_DOES_NOT REQUIRE MATERIALS LICENSEES TO REPORT _ EQUIPMENT FAILURES NRC does not require licensees which use equipment con-taining hazardous materials to report equipment design de-ficiencies or malfunctions.
Licensees use hazardous nuclear materials in industrial radiography 1/, medical teletherapy 2/,
nuclear fuel processing, and irradiation 3/ activities.
They are required to report safety-related incidents--such as over-exposures but are not required to report near incidents re-sulting from malfunctioning equipment.
For these licensees, NRC learns of equipment design deficiencies or malfunctions only when licensees report safety-related incidents, s.
Industrial radiography illustrates how equipment design deficiencies or malfunctions have contributed to safety-related incidents.
From 1971 to 1977, 46 or the 87'significant overexposures reported to NRC--53 percent--occurred in indus-trial radiography, including 16 of the 18 worst overexposures.
An NRC study attributed 40 percent of all radiography overexpo-sures, from 1971 to 1975, in whole or part, to malfunctioning equipment.
NRC found that radiography device manufacturers had made design improvements only after overexposure incidents revealed equipment design and/or manufacturing defects.
One manufac-turer's radiography device had a poorly designed lock which l
permitted the radioactive source to slip to an unshielded
==
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1/The use of sealed sources of radioactive materials in indus-trial applications to examine the structure of materials by nondestructive methods.
2/The use of radioactive devices external to the body to treat diseases.
~3/The industrial use of radioactive materials to sterilize prod-ucts such as pharmaceuticals.
15 i
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lock was redesigned only af ter a safety-related position.
The require reports unless safety-incident.
Because NRC does not it does not know how of ten radiography related incidents occur, equipment has malfunctioned nor does it know if previous over-if it had required routine exposures could have been avoided reporting of equipment malfunctions.
incidents in Some NRC officials believe overexposure radiography could have been avoided if employees had followed approved operating procedures which would have enabled them to than expected radiation levels before being over-detect higher exposed.
In the past, NRC has emphasized instruction and train-Ing for radiographers, but these efforts have not been success-incidents critinue to occur--fre-ful to date as overexposure quently involving equipment malfunctions.
Other NRC officials believe radiography equipment malfunc-One regional office tion is a problem needing NBC's attention.
has asked radiography and medical teletherapy licensees to voluntarily report malfunctions or design problems that could The region believes these reports have enabled cause incidents.
For example, a recurring it to identify equipment problems. teletherapy device used at a university.
in a problem was found this device was being used in three other Upon finding thatregion alerted each licensee of the potential locations, the hazards.
NRC DOES NOT REQUIRE MEDICAL LICENSEES TO REPORT MISADMINIS-
~~
?' RATIONS 2,800 of NRC's 8,000 materials licenses are for the About Another use of nuclear materials in the practice of medicine.
NRC 4,000 medical licenses are regulated by agreement States.
estimates the annual level of nuclear materials administrations NRC does not in the United States has surpassed 30 million.
require medical licensees to report misadministrations, nor do whether NRC inspectors determine, during routine inspections, misadministrations have occurred, Misadministrations at hospitals and other medical facili-NRC officials told us that l
ties have and continue to occur.
licensees voluntarily reported from as few as none to as high as 12 misadministrations to each of the 5 NRC regional of fices about From March 1975 through January 1976, in the last year.
400 patients at an NRC-licensed hospital received excessive radiation from medical teletherapy--a contributing factor in the But NRC did not become aware of i
deaths of several patients.
the misadministrations until April 1976.
Following its investi-NRC required all of its medical teletherapy licensees
- gation, 16 E
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to test their equipment and report the test results.
It is also preparing changes to its medical teletherapy regulations.
Between November 14, and December 13, 1977, a patient at another hospital received twice the prescribed dose of radia-tion.
NRC became aware of the misadministration by chance on December 15, 1977, during a routine inspection when the hos-pital staff--mistakenly believing NRC was investigating the incident--told NRC's inspectors.
In 1972 GAO was aware of the problems in this area and recommended 1/ that the then Atomic Energy Commission (AEC),
require medical licensees to report misadministrations so it could determine the causes and assess whether the licensees had taken adequate corrective actions.
This information could then be analyzed and, if appropriate, AEC could (1) alert other medical licensees of the hazards associated with certain op-erating practices and (2) modify medical licenses or its regu-lations.
AEC, and now NRC, have been considering requiring licen-sees to report misadministrations since our 1972 report.
The requirement has not been imposed, however, because of (1) con-troversy over whether or not NRC should also require licensees to tell patients of misadministrations and (2) confusion be-tween NRC and the Food and Drug Administration (FDA) over their responsibilities in regulating the administration of radioactive drugs and radiation treatments to patients.
In July 1978 NRC published another proposed misadminis-tration rule for public comment.
The proposed rule would require licensees to
--keep records for 5 years of all misadministrations,,and make them available for NRC inspections;
--report all misadministrations related to the treatment of patient diseases or disorders; and
--report diagnostic-related misadministrations which could cause a detectable adverse effect on the patient.
N.
1/" Problems of the Atomic Energy Commission Associated with the Industrial, Regulation of Users of Radioactive Materials for Commercial, Medical and Related Purposes."
(B-164105, August 18, 1972)
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i Licensees would be required to report to NRC, patients' physicians, and the patients, or their relatives or guardians.
In reports to NRC, the proposed rule specifically states that licensees should not name patients, physicians, or other effects on health personnel, but should describe the events, patients, actions taken to prevent recurrence, and whether the patient, relative, or guardian was informed.
As occurred with the rule AEC proposed in 1973, medical community comments on NRC's proposed rule generally oppose mandatory misadministration reporting, and particularly the proposed patient notification part.
Some commenters also stated that the requirement to report diagnostic misadminis-trations which could cause a detectable adverse effect on the patient was not stated with enough specificity to be uni-formly and clearly interpreted and followed.
The underlying reason of the opposition to reporting misadministrations to NRC, and particularly to the patient, is fear of malpractice suits.
Another major reason is that the requirement would constitute an unwarranted NRC intrusion into medical practice.
CONCLUSIONS NRC should extend its event and incident reporting.re-quirements to types of events not now included.
Specifically, NRC should require
--all utilities operating nuclear powerplants to report the same kinds of unscheduled events;
--nuclear materials licensees using equipment containing hazardous radioactive materials to report equipment design deficiencies and malfunctions; and
--medical licensees to report all misadministr'ations of patient radiation treatments and ' radioactive drugs.
In recent years, NRC has imposed more and more surveil-lance requirements on utilities operating newer nuclear power-plants.
This results in increased frequency of event reporting.
NRC attributes much of this' additional surveillance and re-porting to sophisticated plant systems and components in newer plants but not in older plants.
Some of it, however, is due to c
general NRC increases in surveillance reauirements at newer plants for all plant safety systems and components--including NRC has systems and components common to old and new plants.
not, however, also imposed the increased surveillance require-ments on utilities operating older plants.
Thus, for identical or similar systems in older and newer plants, utilities oper-ating the older plants are required to make fewer surveillances 18 l
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--and thus report fewar events--than utilities operating newer plants.
Therefore, NHC's information on the performance of safety systems and components common to both old and new plants is incomplete.
To enable it to fully evaluate the frequency and significance of events which may occur in safety systems and components common to old and new nuclear powerplants, NRC should impose uniform surveillance and reporting requirements on similar systems and components at all nuclear powerplants.
Many NRC nuclear materials licensees use hazardous radio-active materials in equipment which must be carefully designed, manufactured, and operated in order to prevent overexposures to licensee employees or members of the public.
NRC does not, however, license the design or manufacture of this equipment.
Instead, it reviews and approves the applicant's plans for j
safely using the hazardous material for the stated purpose, l
including a description of the equipment and its safety fea-l tures.
Although overexposure incidents occur most of ten with licensees who use equipment containing hazardous radioactive materials, and the causes of these incidents are often attrib-utable in whole or in part to equipment malfunctions or design deficiencies, NRC does not require these licensees to report malfunctions or design deficiencies similar to the way it re-quires utilities to report events at operating nuclear power-plants.
Licensees are only required to report incidents--such as overexposures--to NRC.
In these reports, licensees may identify equipment problems as causes or contributing causes of incidents, or NRC inspectors may reach these conclusions, after investigating incidents.
We believe NRC should require these licensees to report equipment design deficiencies and/or malfunctions when'they are identified or. occur, rather than only when reportable incidents occur.
Such a requirement would enable NRC to promptly identify and act on equipment problems which could contribute to safety incidents.
We continue to believe that NRC should require medical licensees to report misadministrations of radiation and radio-active drugs.
This would enable NRC to (1) determine the causes and whether licensees took adequate corrective actions and (2) e if appropriate, disseminate information on misadministrations to other medical licensees to enhance their awareness of the hazards associated with certain operating practices and improve their controls over the handling of radioactive materials.
- NRC, and AEC before it, has been considering this requirement for over 5 years.
The requirement has not been imposed, however, P
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I because of controversy over the proposed patient notification requirement and confusion about NRC's and FDA's respective i
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Medical community comments generally opposed NRC's particularly the proposed misadministration reporting rule,out of fear of malpractice suits patient notification part, intrusion into medical practice.
In our view, requir-l and NRC is p
ing medical licensees to report misadministrations to NRC intrusion into medical practice.
This is clearly con-L 1
not an sistent with NRC regulatory responsibilities and a necessary part of an ef fective nuclear medicine regulatory program.
this kind of feedback on incidents affecting public Without health and safety, NRC cannot be sure it is adequately regu-lating the possession and use of nuclear materials in medi-cal practice.
Also, as we concluded in our 1972 report, NRC should re-c guire medical licensees to report all misadministrations--wheth-er hazardous to the patient's health or not--because they could potentially indicate weaknesses in licensee operating or manage-ment control procedures.
IJRC should not permit the issue of patient notification to delay requiring medical licensees to report all misadministra-tions to NRC and patients' physicians.
Therefore, in view of the continuing and intensive medical community opposition to the patient notification issue, NRC should delete it from the at a later date; and immediately proposed rule and decide on i' require medical licensees t:
n> gin reporting all misadministra-tions to NRC and to patientre physicians.
RECOMMENDATIONS We recommend that the Chairman, NRC, extend its event and incident reporting requirements to require
--uniform surveillance and reporting requirements on safety systems and components common to all nuclear l
l powerplants,
--nuclear materials licensees using equipment containing hazardous radioactive materials to report equipment design deficiencies and malfunctions, and
--medical licensees to report all misadministrations of patient radiation treatments and radioactive drugs.
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1 The NRC staff said that at this time it does not believe 1
it would be justified in requiring uniform surveillance and reporting requirements on both older and newer nuclear power-plants.
The NRC staf f also disagreed that medical licensees should be required to report all misadministrations to NRC.
The NRC staf f view is that requiring licensees to record all misadministrations and only report to NRC those which could cause a detectable adverse effect on patients would be l
sufficient.
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