ML19257D313
| ML19257D313 | |
| Person / Time | |
|---|---|
| Issue date: | 05/25/1979 |
| From: | Gossick L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Jennifer Davis, Harold Denton, Minogue R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS), Office of Nuclear Reactor Regulation, NRC OFFICE OF STANDARDS DEVELOPMENT |
| Shared Package | |
| ML19257D268 | List: |
| References | |
| SECY-79-371, NUDOCS 8002040088 | |
| Download: ML19257D313 (14) | |
Text
'
f* *lc ueg
+
UNITED STATES E 'y)'% ( j NUCLEAR REGULATORYCOMMISSION
- .'g?
/. j WASHINGTCN, D. C. 20555 a
j'
+....
MAY 2 51979 MEMORANDUM FOR:
H. R. Denton, Director, NRR R. B. Minogue, Director, SD J. G. Davis, Acting Director, NMSS S. Levine, Director, RES N. M. Haller, Director, MPA FROM:
Lee V. Gossick Executive Director for Operations
SUBJECT:
IMPLEMENTATION OF STAFF ACTIONS IN RESPONSE TO GA0 REPORT ON REPORTING UNSCHEDULED EVENTS AT COMMERCIAL NUCLEAR FACILITIES On May 15, 1979, Chairman Hendrie signed the letters transmitting the NRC response to GA0 Report EMD-79-16, " Reporting Unscheduled Events at Commercial Nuclear Facilities:
Opportunities to Improve Nuclear Regulatory Commission Oversight". is a copy of the response.
The Commission made the following commitments:
(1)
The NRC staff will rapidly develop procedures to better utilize the information contained in power plant licensee event reports and materials li nasee incident reports.
(Due date - October, 1979)
In relation to this commitment, the staff will-
-- perform analyses of power plant event reports to assess reporting patterns and to determine the need for additional guidance to licensees;
-- clearly define the scope and frequency of analysis required to identify issues having safety significance;
-- define the minimum requirements for disposition of licensee reports and associated documentation; and
-- ensure that all materials licensee incident reports are collected at its Headquarters and sent to all Regional. offices.
1864 057 204n O
MAY 2 5 1979 Those Listed.
(2)
The NRC staff will examine ways to enhance material licensee awareness and understanding of existing operational safety dah reporting requirements (10 CFR Pai t 20.403 and 21).
(3)
The NRC staff will consider GA0 concerns and recommendations with regard to medical misadministration in its June,1979 submittal to the Commission on the resolution of public comments on the proposed misadministration _ rule published in mid-1978.
(4)
The NRC staff will issue an advance notice of proposed rulemaking to obtain industry and public comments to help NRC in formulating a definitive position on the future status of the Nuclear Plant Reliability Data System (NPRDS).
Item (1) is currently being addressed by an ED0 Task Force on Operational Data Analysis and Evaluation and specific actions are either being implemented or being sent to the Commission for decision.
In addition, at a briefing on April 19, the Commission directed that any problems with distribution of materials licensee incident reports be resolved imediately; Comissioner Ahearne provided the change to the NRC response which detailed the desired improvement in distribution.
Therefore, NMSS (lead), IE, and MPA should take imediate steps to ensure that materials incident reports are received at Headquarters and distributed to all Regional offices.
Item (2) requires action by NMSS (lead), IE, and SD.
NMSS should provide a coordinated plan of action by June 30, 1979, for fulfilling this commitment.
50 should ensure that Item (3) is completed as noted.
SD (lead) and MPA have responsibility for Item (4).
SD should provide a schedule for rulemaking on NPRDS by June 15, 1979.
A target date for publishing the advance notice of rulemaking is December,1979.
MPA should ensure that all staff actions required by our response to the GA0 Report are entered in and tracked by WITS.
f M
&'9T.ee V.kossick Executive Director for Operations
Enclosure:
As stated cc:
Chairman Hendrie Comissioner Gilinsky Ccmissioner.<ennedy 1864 058 Commissioner Bradford "omissioner Ahearne SECY OGC OPE
,- to Gossick memo of 5/25/79 h., i:
- pr The lionorable Jack Brooks, Chairman Committee on Government Operations United States Hcuse of Representatives liashington, D. C.
20515
Dear Mr. Chaire.an:
In accordance with Section 236 of the Legislative P.corganization Act of 1970, the Nuclear Regulatory Commission is submitting the enclosed statement on actions being taken with regard to the recomnendations made by the Comptroller General of the United States in a report entitled,
" Reporting Unscheduled Events at Ccmmercial 'luclear Facilities:
Oppor-tunities to Improve Nuclear Regulatory Commission Oversight", Et10-79-16, dated January 26, 1979.
Sincerely, i
Joseph P1. Hendric Chairman
Enclosure:
Response to CAO Report cc.
w/cnclosure Rep. rrank !!crton 1864 059 d
Identical letters sent to:
The Honorable Gary Hart, Chairman Subcommittee on Nuclear Regulation Cbmmittee on Environment and Public Works United States Senate Washington, D. C.
20510 cc:
Sen. Alan Simpson The Honorable Abraham A. Ribicoff, Chairman Committee on Governmental Affairs United States Senate Washington, D. C.
20510 cc:
Sen. Charles Percy The Honorable Morris K. Udall, Chairman Subcommittee on Energy and the Environment Ccmmittee on Interior and Insular Affairs United States House of Representatives Washington, D. C.
20515 cc:
Rep. Steven Symns The Honorable John D. Dingell, Chairman Succcomittee on Energy and Powar Ccmmi ttee on Inters tate and Foreign Ccamerce Uni ted Sta t c
~u2e ul xeuresentatives Wa'.hington, 9. C.
20515 s
cc:
Rep. Clarence J. Brown 1864 060 0 9 * *C E >.
..~
- * * = - -
.,s.-..., ~.,,.
. +.. - =. ~.,,...--...-...-..,,
Mr. James T. McIntyre, Director Office or Management and Budget Washington, D. C.
20503 Mr. Elmer B. Staats Comptroller General of the United States General Accounting Of fice Washington, D. C.
20548 e
1864 061 OF FtC t D,
S W
- 8e a ne g &
O ntt >
fX ke I II I 4.* 6 ) *i1t P b*
T t'I
- aovh 9 o'**
- T' ** 1 O F F '
-*?a*
l NRC RESPONSE TO GA0 REPORT, EMO-79-16 We concur in the need to define more clearly our assessment objectives, methods, and responsibilities for unscheduled licensee event reports.
We also intend to design better procedural controls for the report a.ssessment process.
The analytical efforts currently. residing in va'rious NRC offices need to be more closely 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 response to each of GA0's recommendations follows:
GA0 Reccmmendation #1 "To provide NRC with reasonable assurance that it promptly 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 for controlling and evaluati6g incident reports with clearly defined objectives, responsibilities, requirements for analyses, and administrative procedures."
NRC Resconse The two items in the GA0 reccmmendation address power plant licensee event reports (LERs) and material licensee incident recorts, respectively.
Our response also treats each i tem separately, a..
Power Plant Licensee Event Recorts As GA0 acknowledges, NRC response to events of im'ediate safety significance at nuclear power plants precedes any written notifi-cation and is governed by established procedures.
Quoting from the GA0 re: ort:
1864 062
"Immediate or 24-hour reports are required (by Technical Specifications) for important events... Utilities must report those 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 offices take acticn on a case-by-case basis in accordance with 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 la-day folicw-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, Regional Offices, again in accordance with written procedure;.
A.s the GA0 report states:
"At NRC regional offices, inspectors are required to assess each licensee event report for (1) the appropriateness of licensee corrective action and the need for follow-up inspection
. ef fort; (2) the event's generic importance to othgr components, systems, or activities within the power plant or at other pcwer
~
plants in the region; and (3) possible reportingJto the Congress as an abnormal occurrence."
GA0 further states that:
" Staffs of the three NRC headouarters offices assess each recort for its safety importance at the power plant, its apoligability to all other power plants and its potential for reporting as an abnormal occurrence."
GA0's findings concerning this review effort essentially are that:
1)
It is " fragmented"; objectives and methods are not established at the Ccmmission 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.."
1864 063 w
ob
2)
It is not auditable:
...neither NRC as a whole nor i ts resoective staff offices has established decision documentation and disposition procedures."
3)
It does not provide for the systematic review of the Leo files to identi fy those problems which derive their sa fety signifi-cance from frequency of occurrence:
"By querying NRC's computerized file of event reports, NRC sta f f were...able to determine that these (safety-related) problems were widespread and significant enough to warrant additions.1 investigaticn.
We believe a more systematic assessment process...would give NRC better assurance that it is promptly identifying all safety-related problems."
GA0's recommendation, then, primarily aims at establishment of Commission-wide procedures to assure completeness and coordination of licensee event report reviews.
NRC concurs in the need tp provide this central coordination to enhance the evaluative efforts residing in the various offices of the Commission.
While NRC also agrees with GA0 on the desirability of ccmplete 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 define the minimum requirements for discosition do.cumentation.
The analysis of collections of events occurring o'ier time and/or at different locations is more complex than the re. view of individual even ts.
Although programs l to identify safety-sig,nificant trends from event reports have been underway, NRC ccncurs in the need to more clearly define the scooe and frecuency of analysis required to identify issues which derive their safety significance from repe ti tion.
1 For examole, Licensef Event Recorts (LERs) nave been use-in a clant-
.by-plant chronological analysis which seeks to identify cat:cens in plant management performance.
As another examole, the O'fice of Nuclear Regulatory Research has an on-going contract s tudy, being cerformed at INEL, to es timate ccmpenent f ailure rates frcm LERs.
The ACRS has also established a Subcommittee en LERs to review the information frem 1975 through 1978 and to reacrt to the Ccrnissicn on its findings by September 1979.
Periodic reviews of LER data and
.cossible trenos are published within NRC.
1864 064
-m
=
4 b.
Materials Licensee Incident Reports Current NRC procedures for respcnding to materials incident reports are similar to those for operating reactors.
However, the program for processing material incident reports has been less structured than that for power plant licensee event recorts.
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 proce.dures.
The GA0 report imolied that~ material incident reports might not be leading to regulatory changes.
Safety problems, however being identified from materials licensee incident reports.2, are
'c.
NRC Actions For both ocwer plant licensee event reports and materials licensee incident recorts, the NRC staff will develcp 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 recognizes that more information is available
' in the LERs than is currently used and intends to 9apidly develop procedures to better utilize this information.
INnincidentat Iscredix, which resulted in overex:osure of an irradiator ocerator, led to 3 rule change which requires interlock sys tems for
.irradiators.
As another examole, changes in licensing requirements in nuclear industrial radiograpny have recently been procosed.
These procosals resulted frcm overexcosure incidents which occurred because of both failure by licensees to cerform procer surveys and certain ecuipment orcblems.
A third examole is the rule change to require calibration of teletherapy units used 'or radiaticn theracy.
7his change is a result of improper dosage to patients uncergoing radiation theracy.
1864 065
.==%
. = = - - -
GA0 Reccmmencation 12 "We recommend that the Chairman, NRC, extend its event and incident reporting requirements to require
-- uniform surveillance and reporting requirements on safety systems and ccmponents common to all nuclear power plants,.."
NRC Response Since 1972 staff efforts have been directed at establishing uniform reporting requirements for all n'uclear power plants.
Ccemon requ ments have been developed as documented in Regulatory Guide 1.16.jre-With few exceptions, all pcwer reactor licensees had technical specifi-cations that required similar events to be reported by early 1976.
The reporting requirements have been designed prinarily.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 (LCOs) and the associated surveillance section of the technical specifications varies;'thus there are variatipns in the number of reports that relate to such failures.
Furthermore, reports relating to a particular ccmponent failure do not haveJ the same safety
~
significance due to differences in plant design.
Scme of the variation in reporting among clants stems from the relatively short time the uniform reporting requirements have been in use.
As ex:erience with interpretation of requirements grows and the tiRC augments the guidance for interpretation more consistent repor. ting should deveico.
The NRC staf f plans to perform analyses of pcwer plant event recorts to assess reporting patterns and deter.ine the need for additional guidance.
T'he subject of uniform surveillance requirements # for old and new plants has been creviously addressed within the Ccmmission in the 3Fer example, all licensees are required to recort an event which involves oceration (unit or system) when any parameter is less conservative than the limiting condition established in the Technical Scecifications.
ISurveillance recuirements specify the acce:tance cri'.eria and the frecuency with which the procer operation or the ability to operate of a carticular system or component must be verified.
1864 066
_2 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 policy has not changed.
However, this has not precluded the immediate imposition of standard surveillance for particular systems on all 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 format of the Standard Technical Specifications.
In addition to this requirement for new Operating L.i. censes, the Commission has a program for converting existing custom technical specifications of old plants to Standard Technical Specifications content and format when the licensee volunteers for this conversion.
This conversion progran results in additional specific surveillance requirements to the technical specifications for these old plants.
To date 16 new Operating Licenses have been issued with Standard Technical Scecifications; 3 old operating licensees have had their previously issued custen technical specifications converted to Standard Tecnnical Specifications; and several other conversions are currently under consideration.
Older plants are currently receiving a detailed safety review under the Systematic Evaluation Program being conducted by the Office of Nuclear Reactor Regulation.
.Needed changes in surveil _ lance require-ments will be identified through this program in the context of each plant design.
1864 067
GA0 Recommendation 63 "We recommend that the Chairman, NRC, extend its event and incident reportir.g requirements to require...
-- nuclear materials licensees using equipment containinc hazarcous radioactive materials to report equipment design de ficiencies and mal functions,..."
NRC Resconse Existing regulations require nuclear materials licensees to report equipnint design deficiencies and nalfunctions.
Materials licensees are subject to 10 CFR Part 21 which requires reporting of defects and noncompliance where a substantial safety hazard is involved.
They are also subject to 10 CFR Part 20.403 which requires report of any incident involvint licensed material which has caused or threatens to cause (1) overex csures to r:diation in excess of the annual allowable limits, (2) ootentially significant releases of radioactivity, (3) a loss of one day or nore of.operatior., or (4) property damage in excess of 52000.
(It should be noted that the Medical Device Amendments of 1976 (P.L.94-295) give the Food and Drug Adminstraticn (FDA) regulatory authority over medical devices, such 6s teletheracy units.
FDA is the proper agency to receive reports of failure or malfunction of medical devices when no radiation hazard is involved.)
The receipt of informtiticn in accordance with NRC reoufrements is dependent ucon licensee awareness and understanding of the rules, an area.shich the NRC may need to emphasi:e.
The PRC s taf f will
~
examine ways to enhance licensee awareness and understanding of existing recorting requirements.
L864 068
GAO Recommendation id "We recorrend 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."
NRC Rescanse NRC has reviewed the GA0 comments and recommendatiens reg rding NRC's policies, practices, and the pecposed rule changes regarding the reporting of misadministrations of nuclear medicines or radiation treatments to patients.
As noted in the GA0 report, th'e Commission staff is currently in the procers of reviewing the public comments received on a proposed misadministration rule published in mid 1973.
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 suomittal to the Ccmmission so the Commission may examine them concurrent with the resolution of publ.ic comments on the proposed rule.
One GA0 concern is that the issue of patient notification is delaying 'inal rulemaking.
GA0 suggests deleting the issue from the proposed rule and deciding the issue later.
Cae approach to reducing the recurrence of serious misadministrations, when and if they occur, involves (1) the determination pf 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 (JJ FRN 2242) regarding the regulation of the medical uses of radioisotcpes.
part of NRC's colicy statement indicates that NRC wiIl regulate the radiation safety of patients where justifie? by the risk to catients and where voluntary standards, or comoliance with these s tandards, are inadequate.
It notes that NRC has the authority to regulate the radiaticn safety of catients.
It further notes that NRC will help ensure that radiation ex osure to patients is af. lev as is reasonably achievable, consistent witn ccmcetent medical care and with minimal intrusion into medical judgments. 'It also states th.a t NRC, wherever cossible, will work closely with Federal and State agencies and crofessional groups in designing new voluntary guidance for practiticners to limit unnecessary patient radiation excesure.
1864 06L9 w~
>e-
.en e
... -.. - e 4
GA0 Reccmmendation L5 "We also recommend that the Chairman, f!RC, resolve the issue of f1RC mandating full nuclear industry participation in the reliability report system by using rulemaking procedures."
itRC Resconse An flRC consensus on whether or not to make the fluclear Plant Reliab.ility Data System (NPROS) reporting mandatory does not exist.
flRC accepts the GAO 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 comments to help NRC in formulating a definitive positi,on.
1864 070
__