ML19289F565
| ML19289F565 | |
| Person / Time | |
|---|---|
| Issue date: | 05/15/1979 |
| From: | Hendrie J NRC COMMISSION (OCM) |
| To: | Staats E GENERAL ACCOUNTING OFFICE |
| Shared Package | |
| ML19261D335 | List: |
| References | |
| NUDOCS 7906110341 | |
| Download: ML19289F565 (1) | |
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UNITED STATES NUCLEAR REGULATORY COMMISSION y.3pg g
w AsHINGTON, D. C. 20555
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May 15, 1979 OFFICE OF THE CH AIRMAN Mr. Elmer B. Staats Comptroller General of the United States General Accounting Office Washington, D. C.
20548
Dear Mr. Staats:
In accordance with Section 236 of the Legislative Reorganization Act of 1970, the Nuclear Regulatory Comission is submitting the enclosed statement on actions being taken with regard to the recomendations made by the Comptroller General of the United States in a report entitled,
" Reporting Unscheduled Events at Comercial Nuclear Facilities:
Oppor-tunities to Improve Nuclear Regulatory Comission Oversight", EMD-79-16, dated January 26, 1979.
\\ Sincerely, L
7 seph M. Hendrie Chairman
Enclosure:
Response to GA0 Report 2077 330 m
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NRC RESPONSE TO GA0 REPORT, EMD-79-10 We concur in the need to define raore clearly our assessment objectives, methods, and responsibilities for unscheduled Itcensee event reports.
We also intend to design better procedural controls for the report assessment process. The analytical efforts currently residing in various NRC offices need to be more closaly coordinated and structured to ensure maximum use of the information reported by licensees.
Improvements in the analysis and handling of reports are considered important in view of the large number of reports we must review and their potential relevance to safety.
Our specific re:ponse to each of GA0's recomendations follows:
CAO Recommendation #1 "To provide NRC witn reasonable assurance that it promptly identifies all safety-related problems from licensee event and/or incident reports, the Chairman, NRC, should t:
-- 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 for controlling and evaluating incident reports with clearly defined objectives, responsibilities, requirements for analyses, and administrative procedures."
NRC Response The two items in the GA0 recomendation address power plant licensee event reports (LERs) and material licensee incident reports, respectively.
Our response also treats each item separately.
a.
Power Plant Licensee Event Reports As GAO acknowledges, NRC response to events of inmediate safety significance at nuclear power plants precedes any written notifi-cation and is governed by established procedures.
Quoting frora the GA0 report:
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i "Imediate or 24-hour reports are required (by Technical Specifications) for important events... Utilities must report those events by telephone or other means of rapid comunication to the nearest of NRC's five regional inspection and enforce-ment offices.
Based on these notifications, NRC regional offices take action on a case-by-case basis in accordance with
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established response procedures."
Thus, NRC is aware of these safety-related events prior to and independent of the written follow-up report which must be submitted within 14 days.
The procedures cited include provisions for coordinating with NRC headquarters offices.
Written licensee event reports (LERs) consist of the 14-day follow-up reports mentioned above and reports which are required by Technical Specifications within 30 days for certain events.
These written reports are reviewed when first received by NRC f
Regional Offices, again in accordance with written procedures.
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As the GAO report states:
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"At NRC regional offices, inspectors are req'. ired to assess each licensee event report for (1) the appro.iriateness of licensee corrective action and the need for follow-up inspection effort; (2) the event's generic importance to other components, systems, or activities within the power plant or at other power
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plants in the region; and (3) possible reporting to the fongress
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as an abnormal occurrence."
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ff GAO further states that:
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" Staffs of the three NRC headquarters offices assess each report 5
b-for its safety importance at the power plant, its applicability to all other power plants and its potential for reporting as an abnonnal occurrence."
GA0's findings concerning this review effort essentially are that:
1)
It is " fragmented"; objectives and methods are not established at the Commission level:
...it (NRC) has left to each of the three headquarters offices and five regional offices the discretion of deciding on the scope and frequency of analyses.."
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It is not auditable:
...neither NRC as a whole nor its respective staff offices has established decision documentation and disposition procedures."
3)
It does not provide for the systematic review of the LER files to identify those problems which derive their safety signifi-cance from frequency of occurrence:
"By querying NRC's computerized file of event reports, NRC staff were...able to determine that these (safety-related) problems were widespread and significant enough to warrant additional investigation.
We believe a more systematic assessment process...would give NRC better assurance that it is promptly identifying all safety-related problems."
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GA0's recommendation, then, primarily aims at establishment of p
Commission-wide procedures to assure completeness and coordination
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of licensee event report reviews. NRC concurs in the need to i
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provide this central coordination to enhance the evaluative efforts residing in the various offices of the Comission.
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While NRC also agrees with GA0 on the desirability of complete review audit trails, there is a tradeoff between the use of technical staff for actual review and problem follow-up and use of the same staff for disposition documentation.
NRC will therefore f.
define the minimum requirements for disposition documentation.
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I-I'l The analysis of collections of events occurring over time and/or at different locations is more complex than the review of individual events.
Although programsl to identify safety-significant trends from event reports have been undemay, NRC concurs in the need to more clearly define the scope and frequency of analysis required to identify issues which derive their safety significance from repetition.
I For example, Licensee Event Reports (LERs) have been used in a plant-by-plant chronological analysis which seeks to identify patterns in plant management performance. As another example, the Office of Nuclear Regulatory Research has an on-going contract study, being performed at INEL, to estimate component failure rates from LERs.
The ACRS has also established a Subcomittee on LERs to review the information from 1976 through 1978 anti to report to the Comission on its findings by September 1979.
Periodic reviews of LER data and possible trends are published within NRC.
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Materials Licensee Incident Reports Current NRC procedures for responding to materials incident reports are similar to those for operating reactors. Howevt.r, the program for processing material incident reports has been let.s structured than that for power plant licensee event reports.
Distribution of and accounting for those reports needs significant improvement.
NRC agrees with GA0 that a better system for controlling and evaluating incident reports can be established.
Such a system would have more clearly defined objectives, responsibilities, requirements for analyses, and administrative procedures.
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The GA0 report implied that material incident reports might not be leading to regulatory changes.
Safety problems, howeve being identified from materials licensee incident reports.g, are c.
NRC Actions For both. power plant licensee event reports and materials licensee incident reports, the NRC staff will develop improvements to existing practices.
The NRC will ensure that all materials licensee incident reports are collected at its Headquarters and sent to all Regional Offices. The NRC recogr izes that more infonnation is available p
in the LERs than is currently used and intends to rapidly develop procedures to better utilize this information, j..
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[I 2An incident at Isomedix, which resulted in overexposure of an irradiator operator, led to a rule change which requires interlock systems for irradiators.
As another example, changes in licensing requirements in nuclear industrial radiography have recently been proposed.
These proposals resulted from overexposure incidents which occurred because of both failure by licensees to perfonn proper surveys and certain
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equipment problems. A third example is the rule change to require calibration of teletherapy units used for radiation therapy.
This change is a result of improper dosage to patients undergoing radiation therapy.
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GAO Recomendation #2 -
"We recomend that the Chairman, NRC, extend its event and incident reporting requirements to require p
-- uniform surveillance and reporting requirements on safety systems and components comon to all nuclear power plants..."
NRC Respe:W e_
Since 1972 staff efforts have been directed at establishing unifom
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eeporting requirements for all nuclear power plants.
Comon requ ments have been developed as documented in Regulatory Guide 1.16.jre-With few exceptions, all power reactor licensees had technical specifi-cations that required similar events to be reported by early 1976.
The reporting requirements have been designed primarily to gather information about events which may have safety significance. Should there be a loss of function of a safety system all licensees are required to submit a report. However, the degree to which safety systems or components are identified in the limiting conditions for plant operation (LCOsl and the associated surveillan:e section of the technical specifications varies; thus there are variations in the number of reports that relate to such failures. Furthermore, reports relating to a particular component failure do not have the same safety significance due to differences in plant design.
Some of the variation in reporting among plants stems from the relatively short time the uniform reporting requirements have been in use. As experience with interpretation of requirements grows and the NRC e
augments the guidance for interpretation more consistent reporting should develop.
The NRC staff plans to perfom analyses of power plant event reports to assess reporting patterns and determine the need for additional guidance.
The subject of uniform surveillance requirements 4 for old and new plants has been previously addressed within the Comission in the 3For example, all licensees are required to report an event which involves c.:
operation (unit or system) when any parameter is less conservative than
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the limiting condition established in the Technical Specifications.
45urve111ance requirements specify the acceptance criteria and the frequency with which the proper operation or the abiltty to operate of a particular system or component must be verified.
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L context of the implementation of Standard Technical Specifications.
The decision at that time was not to arbitrarily backfit standardized surveillance format and content since the benefits of standardization might not be significant in comparison with the effort required.
This
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policy has not changed. Howeser, this has not precluded the immediate imposition of standard surveillance for particular systems on bil plants when justified by the associated increase in safety.
The Commission requires that all new Operating Licenses be issued technical specifications that are consistent with the content and fonnat of the Standard Technical Specifications.
In addition to this requirement for new Operating Licenses, the Commission has a program for converting existirg custom technical specifications of old plants to Standard Technical Specifications content and format when the licensee volunteers for this conversion. This conversion program results in additional specific surveillance requirements to the i
tecnnical specifications for these old plants. To date 16 new Operating i
Licenses have been issued with Standard Technical Specifications; 3 old operating licensees have had their previously issued custom technical specifications converted to Standard Technical Specifications; and sevcral other conversions are currently under consideration.
p Older plants are currently receiving a detailed safety review under j..
the Systematic Evaluation Program being conducted by the Office of i
Nuclear Reactor Regulation. Needed changes in surveillance require-i mants will be identified through this program in the context of each plant design.
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1 GA0 Recommendation #3 "We recoamend that the Chairman, NRC, extend its event and incident reporting requirements to require...
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-- nuclear materials licensees using equipment containing hazardous radioactive raaterials to report equipnent design e
deficiencies and m.alfunctions,..."
NRC Response Existing regulations require nuclear materials licensees to report equipmert design deficiencies and malfunctions.
Materials licensees p
are subject to 10 CFR Part 21 which requires reporting of defects and p
noncompliance where a substantial safety hazard is involved.
They are tf also subject to 10 CFR Part 20.403 which requires a report of any i:
incident involving licensed material which has caused or threatens to cause (1) overexposures to radiation in excess of the annual allowable limits, (2) potentially significant releases of radioactivity, (3) a L
loss of one day or more of operation, or (4) property damage in excess ff of $2000.
(It should be noted that the Medical Device Amendments of 1976 (P.L.94-295) give the Food and Drug Adminstration (FDA) regulatory authority over medical devices, such as teletherapy units.
FDA is p.
the proper agency to receive reports of failure or malfunction of medical devices when no radiation hazard is involved.)
The receipt of information in accordance with NRC requirements is
!h dependent upon licensee awareness and understanding of the rules, I:
an area which the NRC may need to emphasize. The NRC staff will li examine ways to enhance licensee awareness and understanding of existing reporting requirements.
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b GAO Recomendation #4
",We recommend that the Chairman, NRC, extend its event and incident reporting requirements to require medical licensees to report all misadministrations of patient radiation treatments and radioactive drugs."
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.NRC Response NRC has reviewed the GA0 comments and recommendations regarding NRC's policies, practices, and the proposed rule changes regarding the reporting of misadministrations of nuclear medicines or radiation treatments to patients.
As noted in the GA0 report, the Commission staff is currently in the process of reviewing the public comments received on a proposed misadministration rule published in mid 1978.
The Commission will be reviewing the staff efforts in June 1979 to formulate policy. The NRC staff will consider the GA0 concerns and recommendations in its submittal to the Commission so the Commission may examine them concurrent with the resolution of public comments on the proposed rule.
One GA0 concern is that the issue of patient notification is delaying final rulemaking.
GA0 suggests deleting the issue from the proposed rule and deciding the issue later.
One approach to reducing the recurrence of serious misadministrations, when and if they occur, involves (1) the determination of facts, including the causes and corrective actions taken to prevent recurrence, and (2) the dissemination of these facts to other medical licensees to enhance their awareness.
On February 1,1979, the Commission issued a statement of general policy (44 FRN 8242) regarding the regulation of the medical uses of radioisotopes.
Part of NRC's policy statement indicates that NRC will regulate the radiation safety of patients where justified by the risk to patients and where voluntary standards, or compliance with these standards, are inadequate.
It notes that NRC has the authority to regulate the radiation safety of patients.
It further notes that NRC will help ensure that radiation exoosure to patients is as low as is reasonably achievable, consistent with competent medical care and with minimal intrusion into medical judgments.
It also states that NRC, wherever possible, will work closely with Federal and State agencies and professional groups in designing new voluntary guidance for practitioners to limit unnecessary patient radiation exposure.
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P GA0 Recommendation f5 "We also recannend that the Chairman, NRC, resolve the issue of NRC mandating full nuclear industry participation in the reliability report system by using rulemaking procedures."
NRC Response An NRC consensus on whether or not to make the Nuclear Plant Reliability Data System (NPRDS) reporting mandatory does not exist. NRC accepts the GA0 recommendation of utilizing the rulemaking process to fully explore and resolve the issue in a timely manner. The staff will issue an advance notice of proposed rulemaking to obtain industry and public connents to help NRC in formulating a definitive position.
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