ML20134N749

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Forwards Final Abnormal Occurrence Policy Statement & Implementation of Commission Direction
ML20134N749
Person / Time
Issue date: 01/29/1997
From: Ross D
NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD)
To: Bangart R, Miraglia F, Paperiello C
NRC (Affiliation Not Assigned), NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS), NRC OFFICE OF STATE PROGRAMS (OSP)
Shared Package
ML20134N732 List:
References
NUDOCS 9702240421
Download: ML20134N749 (37)


Text

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UNITED STATES NUCLEAR REGULATORY COMMISSION

.,g l January 29, 1997 MEMORANDUM T0: Carl J. Paperiello, Director Office of Nuclear Material Safety and Safeguards Frank J. Miraglia, Acting Director Office of Nuclear Reactor Regulation Richard L. Bangart, Director Office of State Programs Hubert J. Miller, Regional Administrator, RI Luis A. Reyes, Regional Administrator, RII A. B. Beach, Regional Administrator, RIII Leonard J. Callan, Regional Administrator, R FROM: DenwoodF.Ross,ActingDirec\ tor s Office for Analysis and Evaluation of Operational Data

SUBJECT:

FINAL ABN0RMAL OCCURRENCE POLICY STATEMENT AND IMPLEMENTATION OF THE COMMISSION'S DIRECTION In a Staff Requirements Memorandum (SRM) dated November 7, 1996, on SECY 193, the Commission approved publication in the Federal Reaister of the final abnormal occurrence (AO) criteria. The final A0 policy statement (Attachment

1) was published in the Federal Reaister on December 19, 1996, and will be used for the FY 97 A0 report to Congress. The criteria will be available on the network, and the A0 coordinators will be informed how to access them.

In addition, in the SRM on SECY-96-193, the Commission stated that "The staff should file incident information on potential A0s in the public document rooms (PDRs) as soon as possible....In following this direction, the staff should place already-existing documents on these incidents in the PDRs and identify the incident as a Dotential A0."

l l To implement this direction and after discussion with representatives from l your staff, a copy of the memorandum and the attached potential A0 write-up(s) l that your staff fcrwards to AE0D, as directed in the draft Management Directive 8.1, " Abnormal Occurrence Reporting Procedure," should be sent to PDRs. The memorandum, in addition to distribution to PDRs, should include a statement that the NRC staff has identified the event as a potential A0 and if it meets the A0 criteria it will be included in the A0 report to Congress.

This procedure should be implemented as soon as possible. For consistency, j the statement in the niemorandum should be phrased as follows:

9702240421 970218 PDR ORO NOMA g

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"The Nuclear Regulatory Commission (NRC) staff has identified the attached event as a potential abnormal occurrence (AO), and it may be included in the A0 report that the NRC prepares annually to inform Congress of events reported by NRC and Agreement State licensees which the Commission has determined are significant to public health and safety."

Since the memoranda and attached potential A0 writeup(s) will be placed in the PDRs, it is important that the memoranda and writeups have appropriate management review in your organizations before they are issued.

AEOD will revise the draft MD 8.1 to include this new A0 process function.

AE0D will also continue to track all potential A0s and will coordinate with other offices and the regions to determine which events will be included in the annual A0 report to Congress. Harriet Karagiannis of my staff is the contact for any questions on this subject at (301)415-6377.

Attachment:

As stated cc: J. Carter, NRR P. Holahan, NMSS ,

M. Sitek, NMSS P. Larkins, OSP l J. M. Johansen, RI  ;

S. J. Vias, RII t C. M. Hosey, RII R. J. Strasma, RIII A. S. Dauginas, RIII C. A. Hackney, RIV F. R. Huey, RIV l

i l

l

. t, Attachment 1 J .-

l 67072 Federal Register / Vol. 61, No. 245 / Thursday, December 19, 1996 / Notices j Certificates Offered Criteria for the SAi# Standants Commission will use in submitting the Although there is the potential for in rder to qualify for Board annual abnormal occurrence (AO) three levels of knowledge and skills' end rsement, the skill standards system mp rts to Congress and the pubhc m, a recommended by the voluntary umely manner as stated in Section 208 there will be only two types of of the Energy Reorganization Act of cenificates: a basic certificate will artnerships (or the outside groups in b o eMid W have to 1974, as amended. The AO policy encompass either the core alone (if there nwet the following criteria (in addition statement has been revised to provide are no concentrations) or the core plus m r" Specific criteria for determining one concentration level, and a specially to other criteria specified ir the National Skiil Standaros Act): those incidents and events that the certificate w 11 cover the specialty level Commission considers significant from of knowledge and skills. A voluntary . Follow a common nomenclature identified by the Board; the standpoint of public health and j partnersh,p i could establish basic safety for reporting to Congress, and to certificates for up to six concentrations, . Describe in clear terms the critical work functions specific to the core, make the AO policy consistent with The voluntary partnership will concentrations, and specialties; recent changes to NRC regulations. The estaylish the standards for the basic . Describe the acadernic, revised AO criteria contain more certificate (s), which will then be employability, and occupational discrete reporting thresholds making endorsed by the NSSB if it meets the knowledge and skills necessary to them easier to use and ensunng more criteria described below. Outside groups perform the critical work functions for consistent application of the intended (which might include trade associations, the core, concentrations, and specialties: AO reporting policy set forth by the accredited educational institutions and

  • Adhem to statutory requirements Commission.

training providers, and recognized and Board policy on assessment: EFFICTWE DATE: December 19,1996.

third party assessment groups) will

  • De consistent with civil rights law: ADDRESSES: The proposed policy recommend the standards for specialty . ht r exceed the highest statement published in the Federal certificates. These groups di present applicable standards used in the Umted Register (January 9,1996; 61 FR 661),

standards for prospective speciaPy S*8* 8ncluding registered and the comments mccived may be certibcates to the voluntary partnerships 8P.Prenh.eeship standards: examined at the NRC Public Docum mt i for review and endorsement,in the .

Be benchmarked to the best Room,2120 L Street NW. (Lower

' ion s Level), Washington, DC.

same manner that the voluntary * ',"*' 'gg 7 sjand partnersh,ps i will present s.tandards for g aM

. Include a plan for the updating and W NRNER INFORMANN CONTAW basic certificates to the NSSH for review continuous improvement of standards Harnet Karagiannis. Office for Analysis and endorsement. and baluadon of Operadonal Data. U.S,.

and certificates.

In their review of prospective These criteria will pertain to all three Nuclear Regulatory Commission, specialty certificates, the voluntary levels of standards, as well as the two Washmgton, DC 20555, telephone: (301) partnerships will use the same criteria types of certificates. However, as noted 415-6377, mternet: h xk@nrc. gov.

that the NSSH will use to review the earlier, the voluntary partnerships-not SUPPLEMENTARY INFORMATION:

work of the voluntary partnerships the NSSB-- would review the specialty themselves (these criteria are described certificates for adherence to the NSSH's n\8 nia y Public Comments and NRC's below). The voluntary partnerships also pohcms. go, pons, will ensure that the standards for Some of these criteria are required by Hl. Summary of Agreement State Comments prospective specialty certificates buiki the National SkiC J,tandards Act, and NRC's Response directly on the standards for the basic including consistency with civil rights IV. The Commission Policy certificate (s). Specialty certificates could law: meeting or exceeding the highest cover overlapping--or even identical *- applicable U.S. standards; and i'B*ckP*"d I jobs or functions. Hy allowing procedures to periodically revise and Section 208 of the Energy competition among those who develop update the system. Reorganization Act of 1974 (Pub. L. 93-i standards at the detailed specialty level, Signed at Washington. DG this t ath day of the skill standards system can adapt to 438,42 mquired U.S.C. 5848), as the Commission to amended.,t submi to l l Dm ember.14%

changes in technology, work raie we.,' Congress each quarter a report listmg for j organization, and customer preferences. ecume Dures tor NationalSLdlStandards ""Y  ?

  • The Board will require each voluntary noard with any facility which is hcensed or otherwise regulated pursuant to the partnership to develop a plan to meet IFR Dm . W32224 Fned 12-18-%. H 45 aml Atomic Energy Act of 1954, as amended, the needs of expenenced workers. T he swuo coor mo-e" plan will include m its skill standards or pursuant to this Act. In a letter to the

, _ _. _ __ _ Senate Subcomminee on Oversight of system an opportumty to acquire and l Government Management, dated I dem mstrate through assessment the NUCLEAR REGULATORY October 1,1993, the NRC reco e mended skill and knowledge required for the COMMISSION hasic certificate. to Congress a change in the AO report '

publication frequency from quarterly to Voluntary partnerships may begin the Amtmal Occurrence Repods: veariv. As a result, Senate 790," Reports analytical process of developing implementation of Section 208 Energy i:limination Act," Public 1.aw 104-66, standards at the broad core lesel(sl. or Reorganization Act of 1974; Fmal wm signed hv President Clinton on by reviewing the narrower specialties il Policy Statement I)etember 21',1995, changing the AO these already exist in ihe sector. AGENCY: Nuclear Regulatory ~

report to a yearly publication.

Ilowever, the NSSB will only endorse Conunission. For the purposes of Section 20H of the l the work of voluntary partnerships that ACTION: Final polk 3 statement Enemy Reomanization Act of 1974, as j submit basic certificates to the lloard amended, an AO is an unscheduled i before the soluntary partnership suMMAny: This final polin3 statement itu ident or event which the ,

endorses specialty < ertificates. p esents the resised a riteria the Commh.sion has detennined to be 1 l

s.

Federal Register / Vol. 61, No. 245 / Thursday, December 19, 1996 / Notices 67073

~ significant from the standpoint of public policy on a riumber of occasions to The policy statement contains criteria health and safety. Each such report shall ref!cct changes in regulation and policy. that include the reporting thresholds for

. contam: On the basis of these criteria, and as determining those incidents and events (Il The date and place of each occurrence: N9dmd by Section 208 of the Energy that are reportable by NRC for the (2) The nature and probable consequence Reorgam,zation Act of 1974, as purposes of Section 208 of the Energy of exh occurrence; amended, the Commission has issued Reorganization Act of 1974, as l (3) The cause or causes of each; and quarterly reports to Congress on AOs amended. 'I7m Commission has (4) Any action then to prevent recurrence. smce March 1977, These reports, established the reporting thresholds at a The Commission also sball provide as " Report to Congress on Abnormal level that will ensure that all events that wide dissemination to the public of the Occurrences," have been issued in should be considered for reporting to information specified in clauses (1) and NUREG-OO90-6 through to and Congress will be identified. At the same (2) of this section as reasonably possible NUREG-0090, Volumes 1 through 18. time, the thresholds are generally above within 15 days of its receiving 13ased on its experience in the the normal level of reporting to NRC to information of each AO and shall preparation and issuance of AO reports, exclude those events that involve some provide as wide dissemination to the the Commission has decided that its variance from regulatory limits, but are public as reasonably possible the responsibilities under Section 208 of the not significant from the standpoint of information specified in clauses (3) and Energy Reorganization Act of 1974, as public health and safety.

(4) as soon as such information becomes amended, can be carried out more appmpriately if the existing AO criteria Ucensee Reports available.

In July 1975, m the exercise of the are revised to reflect changes in the This final general statement of policy

authority conferred upon the Commission's policy and changes to the will not change tr e reporting Commission by Congress to determine regulations. rt.quirements imposed on NRC licensees which unscheduled incidents or events The NRC staff proposed to the by Commission regulations, license are significant from the standpoint of Com.nission the final revision of the AO conditions, or technical specifications public health and safety and are criteria in 1995 The Commission (TS). NRC licensees will continue to
reportable to Congress as AOs. the approved publication in the Federal submit required reports on a wide Commission developed interim criteria Register of the AO criteria (J.muary 9, spectrum of events, including events for evaluating licensee incidents or 1996. 61 FR 661), for a 90-day public such as instrument malfunctions and events. On the basis of these interim comment period. The NRC staff deviations from normal operating criteria and as required by Section 208 evaluated public comments and procedures that are not significant from of the Energy Reorganization Act of developed the final AO policy the standpoint of the public health and 1974, as amended, the Commission statement. The Commission is issuing safety, but do provide data useful to the 1 began issuing quarterly reports to this final general statement of policy Commission in monitoring operating i Congress on AOs. These reports ' that describes the manner in which the trends of licensed facilities and in

" Report to Congress on Abnormal Commission will, as part of the routine comparing the actual perfonnance of i Occurrences," have been issued in c nduct ofits business, carry out its these facilities with the potential j NUREG 75/090 and NUREG-0090-1 responsibilities under Section 208 of the performance for which the facilities Energy Reorganization Act of 1974, as were designed and/or licensed.

through 5 for the period from January 1975 through September 1976. On the amended, for identifying AOs and Information pertaimng to all events I hasis of its experience in the reparation making the regmsite information reported to the NRC will continue to be c neerning e ch occurrence available to made available and placed in the pubhc and issuance of AO reports,t e Congress and ....: pubhc m a timely document rooms for pubhc perusal. In Commission issued a general statement manner. Included m this policy addition, the NRC publishes annual of policy that described the manner in reports on events (NUREG--1272 series).

which it would, as part of the routine statmnent am cyiteria that the ,

Cmumission will use in determ,ning Information can also be obtamed by i

conduct of its business, carry out its writing to the U.S. Nuclear Regulatnry whether a particular event is a responsibilities under Section 208 of the reportable AO withm the meaning of. Commission, PuL:.u muumat Houm..

Energy Reorganization Act of 1974, as Section 208 of the Energy 2120 L. Street, NW. (Lower Level) amended, for identifying AOs and Washington, DC 20555-0001. In Reorgamzation Act of 1974, as ,

making the requisite information addition, the Commission will continue i

toncerning each occurrence available to amended. It is expected that as additional expenence is gained, changes to issue news announcements on events j Congress and the public in a timely m the cnteria snay be required. that seem to be newsworthy whether er i manner. This general statement of n t they are reported as Ads.

policy was published in the Federal Abnormal Occurrence Reporting Rrgistir on February 24,1977 (42 FR The general statement of policy has II. Summary of Public Comments and 10950) and provided criteria and been developed to comply with the the NRC's Response examples of types of esents that th" legislative intent of Section 208 of the The NRC decided to revise the AO Commission would use in determining Energy Reorganization Act of 1974, as criteria to reflect changes in NRC whether a particular event is reportabl" amended, to keep Congress and the regulations and policy. Ilefore arriving to Congress as an AO. The Commission public informed of unscheduled to the revised AO criteria, the NRC staff I l has since refined this statement of incidents or events which the esaluated several AO approaches and l Commission considers significant from consulted with experts in the reactor and nuclear material areas, including shr$.*n fiNcWtU r ennnna una e. te o nox nonzi. washmgion. In:

7 the stamipoint safety. The pt pohey public health reflects a and range of the Advisory Committee on the Medical l zu402snan ropa ,.re ahn audalA* frnnot c health and safety concerns and is Uses of Isotopes ( ACMUI), and held j  % hon llet hnu al informAun Serm e. 52H Pod applicable to incidents and evt nts uorkshops with Agreement States to a a er ir ce ut

.it i i n.a.xc r,au immen, a t.

m. mn o s,, sw as well adhose having an overall to ensure that only events that have the tiewer inell, washmpon nc MH7 linpact on the general public. potential for significant health and

3 67074 Federal Register / Vol. 61. No. 245 / Thursday Decuocer 19, 1996 / Notices U safety consequences are reported to signed by the President on December 21, lens of the eye. Thus, the bone marrow Congress. After an evaluation several of 1995, <. hanging the AO report to a yearly and the gonads should be in the the early written comments provided by publication. Because the report was not' category of any individual organ or

, the States were incorporated in SECY- eliminated in the " Federal Reports tissue except the lens of the eye, to be 94-275, " Revised Abnormal Ot currence Elimination and Sunset Act," the NRC consistent with to CFR Part 20, using Criteria" that provided the qpmmission concludes that the AO report remains the revised AO dose threshold for other a draft of the revised AO cnteria as valuable to Congress. organs of 2500 mSv (250 rem).-

requested in an SRM of May 19,1994. Comment: Discontinue the appendix Response:The NRC did not intend to A Federal Register Notice (FRN) of the AO report on "Other Events of be consistent with the dose thresholds (January 9,1996; 61 FR 661) on Interest" because (a) there is no legal as listed in 10 CFR Part 20. " Planned

" Abnormal Occurrence Reports: justification for the development of this special exposures," which impose doses Implementation of Section 208 Energy appendix;(b) tha NRC does not have a five times the annual regulatory limits P.eorganization Act of 1974; Proposed fair mechanism for ascertaining public during the individual's lifetime. Based Policy Statement" was published for a perception; and (c) events may be on NRC's experience, unlike a PSE, an 90-day public comment period, that perceived as Aos and give the AO unintended exposure event is based included the proposed AO criteria. No appearance of safety significance when on radiation consequences from that additional comments were received no such finding was assigned to them. single event and not the radiation from Agreement States or ACMUIon the HeSPonse: Based on NRC's consequences over the individual's proposed AO policy statement as experience, some events have attracted lifetime. The NRC agrees, however, that published in the FRN. wide Longressional and public interest. the AO dose threshold to the lens of the The NRC received five letters of Exanyples are events that resulted in eye, the bone marrow, and the gonads comment on the revised AO policy petitions to the Commission by pubh.c should be increased. To be consistent statement published m the FRN from mterest groups, events that may have w th the AO threshold used for medical the followmg organizations: Wrgm,a i resulted in power reductions or misadministrations, the thr9shold to the Power; the Clean Water Fund of North shutdowns for safety-related reasons . lens of the eye is raised to 1 Sv (100 Carolina: the American College of and events mvolving widespread media rem)instead of the proposed 500 mSv Nuclear Physicians Califorma Chapter; coverage. Some of these events have (50 rem). The 1 Sv (100 rem) dose the Government Relations Office of the also resulted in sigmficant regulatory threshold is still below the dose for American College of Nuclear effort, such as an NRC Incident

,, known deterministic effects in the lens Physicians / Society of Nuclear Medicme; Investigatm, n Team response. Although of the eye such as cataracts. INCRP and the Nuclear Energy Institute. These these events are not required by law comments may be examirkd at the U.S. be listed in Au reports, the Commenta No.7)

Also, the dose threshold for the bone Nuclear Regulatory Commission, Public Commission, as a matter of marrow and gonads will be revised to 1 Document Room 21,20 L Street, NW. discretionary policy, directed the NRC Sv (100 rem)instead of the 2500 mSv (Lower Level) Washmgton, DC 20555- staff to mclude them to keep Congress 0001, Each letter contamed more than , (250 rem) recommended in the and the public fully informed. comment. The revised dose is still at the one comment, and these comments are

,The NRC has not develo ed specific threshold for temporar bone marrow categorized into three groups: (1) modify criteria for the appendix o the AO depression but below t e dose threshold and/or discontmue the AO reportmg report on ' Other Events of Interest.,, for permanent sterility from a single i

process; (2) revise the dose threshold for rh,s i allows discretion on the part af the dose to the gonads or serious reporting AO events to Congress on NRC in the selection of the events t consequences due to bone marrew unmtended exposures to an adult and a ensure exclusion of unimportant events. depression. For AO purposes, the bone minor or an embryo / fetus; and (3) To avoid confusion, the "Other Events marrow and the gonads are separated reevaluate the AO criteria applicable to of Interest listing will have a full from the rest of the organs (unlike 10 l

i medical licensees. Pubhc comments on descriptmn,of the basis for inclus. ion of CFR Part 20), due to the deterministic the proposed policy statement and each event m the report and a clear effects to these organs at the revised AO NRC's response are presented below mdication that these events are not AOs. dose thresholds.

followed by a section on the summary Comment: The annual total effective of Agreement State comments and B Revise the Dose Thresholdfor

Reporting AO Events to Congmss on dose equivalent (TEDE) for AO reporting
NRC s response. Unintended Evposures to on Adult and for members of the public should be l A. Modify and/or Discontinue the AO a Minor or an Embryo / Fetus reduced to less than 4.50 mSv (0.450 HePorting Process Comment; a. Because the revised rem)instead of the proposed TEDE of Comment
Because people who unintended AO dose threshold values 250 mSv (25 rem).

for the whole body and any individual Re8Ponse: According to the Nat,onal i receive the quarterly AO reports do not C, uncil on Radiation Protection and even read them, and the few that do organ or tissue except the lens of the eye Measurements, the estimated average believe the reports have sittle true value, are generally consistent with the V l" the NRC should request legislation to " Planned special exposures" (PSEs) of discontinue the AO reporting process. 10 CFR Part 20 (five times the annual

'[' ,d Sta f iel j radiation and man-made sources is Response:The value of the A0 report regulatory hmits), for consistency the l ,

dose threshold for the lens of the eye opI3roximately 360 mrem penyear.2 This l to Congress was recently examined m .

' dose value is about the same as the the legislation reducing the publication should be revised to 750 millisievert c mmenW s suggested dose threshold frequency of the report from quarterly to (mSv)(75 rem),instead of the proposed f r up rting Aos mvolving members of annually as recommended by the NRC AO threshold of 500 mSv (50 rem).

in a letter of October 1,1993, to the b.10 CFR 20.1201(a)(1)(ii) specifies the public to Congress. Reporting to Senate Subcommittee on Oversight of the annual occupational limit for the ,

Government Management. As a result, sum of deep-dose equivalent and the at ihe tinited sinies. NcKP Report No. 93 National Senate 790," Reports Elimination and committed. dose equivalent to any council on Radiation Protecnon and Measuremena Sunset Act," Public Law 10446, was individual organ or tissue except the Septernher 19R

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Federal Register / Vol. 61. No. 245 / Thursday. December 19, 1996 / Notices 67075 C. Reevaluote the AO Criteria eliminate reporting events to Congress Congress each exposure of a member that do not have any medical the public due to NRC-licensed Applicable to Afedical Licensees activities at the level of the averap c ae significance.

Cornment:The proposed medical AO

, received annually from natural and Response:The NRC believes that the criteria are worse than the current dose thresholds of the revised criteria man-made sources of radiation in the criteria because they will continue to have sufficient margin included to limit United States is inappropriate.The NRL, inappropriately designate non. the reporting of insignificant events. In selected the revised AO dose on the significant events as AOs. addition, the NRC considers it basis of the potential for radiatior' Response:The revised medical AO important to report events that have the adverse health effects to an mdm. dual- criteria should result in fewer AOs than independent of the individual s status have been reported previously to Potential to result in adverse public nealth and safety. The inclusion of the as a radiation worker in an occupational Congress. These revisions were made in recommended criterion would preclude environment or as a member of the response to NRC staff recognition of the re; orting of these events. Therefore, the public. This threshold is below the level previous low dose thresholds that NRC does not intend to include the of dose for which the potential for resulted in reporting events that did not morbidity is considered sigmficant for have significant radiation consequences. pmposed language.

individuals with an mcreased organ and in addition, the new criteria a%

, Comment: Insignificant medical events have been included in the past tissue sensitivity to radiation. respond to previous public criacism Comment:The annual TEDE to any and to changes in other NRC regulations AO reports to Congress.

relating to radiation protection. Response:The NRC understands the minor or embryo / fetus should be reduced to less than 3.50 mSv (0.350 Comment:The AO criteria applicable commenters' concerns with the rem)instead of the proposed TEDE of 50 to medical licensees should be excluded implementation of the medical AO from the AO policy statement becau.,e policy before the revision. Because of mSv (5 rem). the low dose thresholds established in Response: The NRC understands the the NRC does not he.T sufficient sensitivity of an unintended. exposure to competence in medicine andthat pharmacy the the have not had previous potentialcriteria, to result medical eve a minor or an embryo / fetus and to determine public safety significance of medical events. in significant radiation consequences to ,

recognizes that the radiation health patient.4 were determined to be AOs and '

effects are age dependent because Response: Because the NRC regulates byPmduct materialincluding the were reported to Congress. At a result, organs and tissues in minors, futuses, medical use of this material, criteria for the Commission is revising the AO and embryos are more radiosensitive medical events have been developed criteria dose thresholds for medical ,

than a typical adult. Therefore, a dose and must be included in the AO policy events to exclude msignificant events. j threshold of 50 mSv (5 rem) was established for any minor or embryo / statement to comply with Section 20a of Ill. Summary of Agreement State  !

Comments and NRC's Response i fetus, which is lower than the adult AO the Energy Reorganization Act of 1974' as amended. The revised criteria are Seven Agreement States submitted threshold of 250 mSv (25 rem). based on widely accepted standards for In addition, the commenter's radiation protection and were reviewed comments to the NRC before suggested threshold of 3.50 mSv (0.350 development of the Commission paper, by the ACMUI. Therefore, the NRC SECY-94-275," Revised Abnormal rem)is at or below the average dose that believes that evmyts exceeding the Occurrence Criteria., These States were a person (including minors) in the criteria are sufhciently important to United States receives annually from Arkansas, Georgia, Kentucky, New York.  ;

mfor Congress and the public. 'lexas. Tennessee, and Washmgton.

natural radiation and man.made sources Comment: Congress may obtam as stated in the response to an earlier inf rmation on significant medical After evaluating the comments, several i comment. The threshold established by events from the FDA instead of the NRC. were incorporated m the Commission NRC is below the minimum threshold Re5Ponse:Section 208 of the Energy paper. A summary of the Agreement doses for permanent deterministic State comments applicable to the AO Re rgaru,zati n Act f1974,as effects in selective organs for a minor or amended. requires reporting to Congress critena listed in the proposed"' pokcy d

'm embryo / fetus' licensee events that the NRC determines statement as published in

  • to be significant from the standpoint of NRC's response are presented below:

Comment:The criteria related to a nursing child, fetus, or embryo as a public health and safety. An enactment b "

  • result of an exposure to a nursing of law would be necessary to change nhnw ern8 e PPo%

mother or pregnant woman should be this requirement and appoint another "

deleted from the criteria until th" agency such as the FDA to undertake Comment: Four States commented on proposed rule addressing these the AO responsib lity.

the specific guidelines of a prior exposures is resolved through the Comment: ACMUI should review the revision of the proposed appendix of the advice of the Advisory Committee on medical AO crit tria, AO report on "Other Events of Inte wt" Medical Uses of isotopes (ACMUI) and Response:The revised criteria were presented to ACMUI and comments er wanted "Other Events of Interest" a separate public comment period. deleted.

received were incorporated before Response:The NRC recognizes the Response:it should be noted that the

! lack of a specific regulation to address publishing them in the Federal Register section on "Other Events of Interest" exposures as a result of an unintended (January 9.1996: 61 FR 661). Only contained in this final AO policy administration of radioactive material to minor changes have been made to the statement has been revised since the criteria since ACMUI's review, a patient that is pregnant or nursing. time that Agreement States provided Hased on NRC's experience, some of Comment: Add a third condition to the medical AO criteria to read:"and (c) comments, and therefore comments on these events have the potential for is a radiation exposure that has resulted the specific guidelines of the section do significant health and safety not apply. In referem.e tu the in unintended permanent functional consequences to a minor or an embryo / damage to an organ or a physiological elimination of "Other Events of fetus and should be reported to

( system as determined by a physician" to Interest," see NRC's response to the Congress.

s- 8 67076' Iederal Register / Vol. 61. No 245 / Thursday, Ikember 19, 1996 / Notices second public comment under Category establish a single-dose threshold salue not yet developed a regulation A. to identify doses to an occupational establishing a dose threshold for

  • Comment: One State suggested that worker,a member of the public, and a reponing these events to the NRC.

the AO criteria should apply to wrong individual (wrong patient),5 Response: See response to fourth exposures from non. Atomic Energy Act which are significant from a health and public comment under Category B.

( AEA) material. safety standpoint. The basis was that, IV. The C,ommission Poh.oy--General Response: Section 208 of the Energy for the purpose of reporting to Congress.

Reorganization Act of 1974, as the potential for physical harm to an

'**'"I "I I"IICY "" I*P I '**"""

of Section 208 of the Enemy amended, provides that the Commission individual resulting from the shall submit to Congress each yea / a unintended exposure is the same "4* ""* I"" ^ C ' *I I * ' **

Amended report listing for that period any AOs at whether the exposure ,,as received in or associated with any facility which is an occupational setting. as a patient 1A PPlicability. Implementation of licensed or otherwise regulated who was not intended to receive a Section 208 of the Energy pursuant to the Atomic Energy Act of prescribed dose, or as c member of the Reorganization Act of 1974, as 1954, as amended, or pursuant to this public. amended. Abnormal Occurrence Act. Therefore, the AO criteria will not Comment: Three States suggested Reports, involves the conduct of apply to events involving the use of providing credentials for a " physician" Commission business and does not non. AFA material since this material is as listed in criterion I.A.3. impose requirements on licensees.

not regulated by the NRC. Response: For general purposes the Reports will cover certain unscheduled Comment: One State commented that term " physician" is defined in to CFR incidents or events related to the the AO policy statement imposes Part 35.2, where " Physician means a manufacture, construction, or operation additional requirements on licensees. medical doctor or doctor of osteopathy of a facility or conduct of an activity Response:The AO policy statement licensed by a State or Territory of the subject to the requirements of Parts 20, will not change the reponing United States, the District of Columbia, 30 through 36,39,40,50,61,70,71,or requirements imposed on NRC licensees or the Commonwealth of Puerto Rico to 72 of Chapter I, Title 10. Code of Federal by Commission regulations, license prescribe drugs in the practice of Regulations (10 CFR).

conditions, or technical specifications. medicine ' Through an exchange of information, The NRC licensees will continue to Although the NRC regulations do not Agreement States provide information submit required event reports. The AO specify the detailed credentials of a to the NRC on incidents and events criteria will only be used by the NRC " physician" for incident evaluation involving applicable nuclear materials during internal mview and evaluation purposes, the NRC staff has developed that have occurred in their States. Those for reporting significant events to an NRC Inspection Manual Chapter events reported by Agreement States <

I 1

Congmss. (IMC 1360)"Use of Physicians and that reach the threshold for reporting as Comment: One State commented that Scientific Consultants in the Medical an AO are also published in the " Report l criterion I.A.3 is arbitrary. Consultant Program" that provides to Congress on Abnormal Occurrences." ,

Hesponse:The NRC disagrees. guidance on the use of NRC consultants 2. Definition of tenns. As used in this flecause individual sensitivity to in case of an incident. In addition, the policy statement:

radiation varies, the basis of criterion NRC staff has developed NRC (a) An " abnormal occurrence" means 1.A.3 is to capture those events that have Management Directive 8.10. "NRC an unscheduled incident or event at a resulted in unintended, permanent Medical Event Assessment Program" to facility or associated with an activity 1 t

' ensure timely and comprehensive that is licensed or otherwise regulated,  ;

functional damage to an organ or a phpiologicar system at thresholds review of medical events. IMC 1360 and pursuant to the Atomic Energy Act of l below those listed in the AO criteria. Management Directive H.10 are available 1954, as amended, or the Energy l in the NRC public document room 2120 Reorganization Act of 1974, as j llowever, the NRC believes that there I, Street, NW. (l.ower level), amended, that the Commission J will be very few of these events. In most Washington, DC 20555-0001, determines to be significant from the cases permanent organ and standpoint of public health and safety; physiological damage will occur only at B. He Consistent With the Regulations ""U duses above the proposed AO and Reconsider the Cnterion for a (b) an ,, unintended radial.me thresholds umn, or un E.m bryoFetus exposure" includes any occupational Comment: One State commented that criterion I.D.3 is arbitrary. Comment: One State commented that exposure, exposure to the general Response: The NRC disagrees. Based the AO criteria should be consistent public, or exposure as a msult of a on NRC's experience, certain reported with to CFR Part 20. medical misadministration (as defined events, although they did not result in HeNPonse:To the extent practical, the in S 35.2) involving the wrong NRC has been consistent with 10 CFR individual that eweeds the reporting significant radiation consequences, had Part 20, and at the same time has values established in the regulations.

f the potential for adverse impacts on established thresholds to include only All other reported medical public health and safety because of a events that have the potential to result misadministrations will be considered l serious failure of the licensees's for reporting as an AO under the criteria I radiation protection program and lack or in deterministic effects due to for medical licensees. In addition, unintended exposures.

management control and oversight and C nunent:Two States expressed unintended radiation exposures include should be reported to C(mgress. concern about developing an AO dose any exposure to a nursing child, fetus, Cornment: Two States commented thn shold for events regarding a minor, or embryo as a result of an exposure

^

ciat " wrong patient" should be (other than an occupational exposure to considered in the misadministration AO or an embryo / fetus sin < c the NRC has critena instead of the general AO an undeclared pregnant woman) to a

"'h"d""'8"d"""'""""d$"P'"*'"' nursing mother or priynant woman criteria applicable to all licensees. " "" "

above specified values.

Response:In the SRM of May 19, $ C j [ j , $ n'"g]i j [ " ", vn,- 1 Abnormal orcorrence general 1994, on SECY-93-259, the NRC statf waan c me werno ,h,, u rm m rong p.

was diru ted by the Commission to  % repto ca w ihcerm wrnog mmuanal statement of pohry. The Commission llp

! gr "

,dg . .

i iw6 / Notices (17077 Federal Regisler / Vol 61. No. m / t hursde. December 19.

l gieater than 'he regulatory limits in to

. will be a onsidered for repoiting n AOs will apply the following policy in CFR 71 Sl(a)(2).

determining whether an incident or are as Inlinw s.

C. Thel't. Diversion, or I.oss of Liu*nsed

, event at a facihty or insolving an L Fo I cens m activity that is licensmi or otherwise atend r Sabotage or Secunty A Ilum,m Exposure to Radiaoon From Hmach

1. Any umntended radiation exposure sources that exceed 0.01 times the Ai amended. to an adult (any mdisidual la years of salues, as listed in 10 CFR Part 71, An incident or event will be aHe 9 older) resulting in an annual total appendix A. Table A-1, for special form considered an AO ifit involves a major f 0 (sealed /nondispersible) sources, or the elI",:1 mdhs!ve reduction in the degree of protection of mvert dose (mSv)(25 equivalent rem) or more; (TEDE) or o 25 of the A2 or 0.01 times the A, smaller the public health or safety. This type of an annual sum of the deep dose values, as listed in Table A-1, for incident or event would have a equivalent (external dose) and normal form (unsealed /dispersible) moderate or more severe impact on the mmmitted dose equivalent (intake of sources or for sources for which the public health or safety and could radioactive material) to any mdividual form is not known. Excluded from inchide, but need not be limited to the organ or tissue other than the lens of th" reporting under this criterion are those following: eye, hone marr w and the gonads, of events involving sources that are lost, (t) Moderate exposure to. or release of. 2500 mSv (250 rem) or more; or an stolen, or abandoned under the radioas.tive material licensed by or othermse annual dose equivalent to the lens of the following conditions: sources regulated by the Commission; eye, of I Sv (100 rem) or more; or an abandoned in accordance with the (2) Major degradation of essential safety. annual sum of the deep dose equivalent niquirements of to CFR 39.77(c); sealed related equipment; or and committed dose equivalent to the sources contained in labeled, rugged (1) Mator deficiencies in design. source housings; recovered sources with

"' "" " "" ' "d R " d8' SV f rie i fa itie s r i - (100 rem) or more; or an annual sufficient indication that doses in excess shallow , dose equivalent to the skin or of the reporting thresholds specified in Critena by type of event used to extremities of 2500 mSv (250 rem) or Au criteria I. A.1 and I. A.2 did not occur determine which mciderits or events more. during the time the source was missing; will be considered for reporting as AOs are set out m, appendix A of this policy 2. Any unintended ra-liation exposure and unrecoverable sources lost under to any minor Ian individual less than 18 such conditions that doses in excess of statement. the reporting thresholds specified in Ao

4. Commission disseminotion of years of age) resulting in an annual TEDE of 50 mSv (5 rem) or more, or to criteria I.A.1 and I.A.2 were not known potential AO ond AO information to have occurred.

,(a) The Comrmssion will provide as an embryo / fetus resulting in a dose wide a dissemination of information to equivalent of 50 mSv (5 rem) or more. 2. A substantiated case of actual or

3. Any radiation exposure that has attempted theft or diversion of licensed material or sabotage of a facility, ir o atio on t n ia s vents resulted in unintended pennanent
3. Any substantiated loss of special that may meet t AO criteria) will be I""d.i nal damage to an organ or a nuclear material or any substantiated sent to the NRC Public Document Room Physiological system as determined by a mventory discrepancy that is ludged to and alllocal ublic document rooms as physician. be sigmficant relative to normally soon as possible after 'he staff l B. Discharga or Dispersal of Radioactive expected performance, and that is determines that the incident is a potential AD. A Federal Register notice Material From its Intended Place of judged to be caused b theft or d,iversion will be issued on each AO report with Confinement r by substantialbrea down of tk accountability system.

copies distributed to the NRC Public 1.The release of radioactive matenal Document Room and alllocal public 4. Any substantial breakdown of t an unrestricted area m concentrations physical security or material control document rooms. When additional which,if averaged over 4. period of 24 information is anticipated, the notice uuurs, exceed 5000 time.6 the values (i.e., access control containment or  !

will state that the information can be specified in Table 2 of appendix B to 10 accountability systems) that CFR Part 20, unless the licensee has sigmficantly weakened the protectwn obtained at the NRC Public Document Room and in all local public document demonstrated compliance with against theft, diversion, or sabotage.

rooms. S20.1301 using S 20.1302 (b) (i) or D. Other Events (i.e., Those concerning (b) Each year, the Commission will Design, Analysis, Construction, Testing.

submit a report to Congress living for 20.1302 (b)J2) (ii). Operation, Use, or Disposal of Licensed

2. Radiation levels .m excess of the that period any AOs at or associated design values for a package, or the loss Facilities or Regulated Materials) with any facility or activity which is of confinement of radioactive material 1. An accidental cn.ticality (10 CFR licensed or otherwise regulated resulting in one or more of the pursuant to the Atoraic Energy Act of 70.52(a)).

following:(a) A radiation dose rate of 10 2. A major deficiency in design, 1954, as amended, or the Energy I

mSv (1 rem) per hour or more at 1 meter construction, control, or operation I Reorganir.ation Act of 1974, as amended. This report will contain the (3.28 feet) from the accessible external

! surface of a package containing 'Information pertaining to certai, incidents rnay

' date, place, nature, and probabb radioactive material;(b) a radiation dose l ""*

consequence of each AO, the cause or rate of 50 mSv (5 rem) per hour or more r

! causes of each AO, and any action taken on the accessible extemal surface of a $h"E '". N"i i n$Un"$$' " '"

implications clauiried information will be wdbheld when formally reporting these incidents to prevent recurrence. package containing radimctive material in accordance with Section 208 of the Energy Appendix A-AbnormalOccurrence and that meet the requirements for "classified "8"""*"""^C' ' ' 8" "' ""'"d*# ^ " Y

.. exclusive use" as defined in 10 CFR details regarding these incidents would Criteria tm available to the congress. upon request. under l

71.47; or (c) release of rad.ioactive Criteria by types of events used to appropriaie security arrangements.

material from a package in amounts dt'lermine which incidents or events

.= . .

'S7D7B . Fed:ral Regisler / Vol. 61 No. 245 / Thursday,1)ecember 19, 1996 / Notices having significant safety implications (a) Results in a dose that is (1) equal Deconunissioning Activities Report requiring immediate remedial action. to or greater than 1 gray (Gy)(100 rads) (PSDAR) for the Saxton Nuclear

3. A serious deficiency in to a major portion of the bone marrow, Experimental Corporation (SNEC) management or procedural controls in to the lens of the eye, or to the gonads, Facility (SNEF) located near the major areas. or (2) equal to or greater than 10 Gy florough of Saxton, in 1.iberty
4. Series of events (where individual (1000 rads) to any other organ; and Township Iledford County, events are not of major importance), (b) Represents either (1) a dose or Pennsylvania. A public meeting on the

, recurring incidents, and incidents with dosage that is at least 50 percent greater SNEF PSDAR will be held in the Saxton l implications for similar facilities than that prescribed in a written Fire llall located at 8th and North l (generic incidents) that create a major directive or (2) a prescribed dose or Street, Saxton, Pennsylvania 16678 on safety concern. dosage that (i)is the wrong January 28,1997, at 7:00 p.m.

il for Commercial Nuclear Power Plant radiophannaceutical,' or (ii) is delivered Reactor operations at SNEF were b""8 by the wrong route of administration, or terminated in May 1972. The reactor is (iii) is delivered to the wrong treatment defueled, with teactor fuel removed A. Malfunction of Facility, Structures, site, or (iv) is delivered by the wrong from the site, and the reactor cooling or Equipment treatment mode, or (v)is from a baking system is drained. SNEC submitted the

1. E.xceeding a safety h.tmt of license source (s)- SNEF Decommissioning Plan (DP) dated techmcal specification (TS) [S 50.36(c)L February 16,1996, to the NRC in V. Guidelines for "Other Events of accordance with NRC regulations in

, 2. Serious degradation of fuel Interest" mtegrity, primary coolant pressure effect at that time. The licensee boundary, or primary contamment The Commission may determine that submitted the SNEF Decommissioning events other than AOs may be ofinterest Environmental Report on April 17,

"" "4 to Congress and the public and be 1996. On July 18 and November 8,1996,

3. Loss of plant capability to perform essential safety functions so that a ncluded in an appendix to the AO the licensee submitted additional release of radioactive materials, which report a '*0ther Events of Interest." information on the DP and could result m exceeding the dose hm.ts Guidelines for events to be included in environmental report in response to a i

of 10 CFR Part 100 or 5 tims the dose the AO report for this purpose are items request for sdditional information from that may possibly be pesceived by the the staff. When proposed amendments hm,ts i of 10 UR Part 50, apcendix A' public to be of health or safety to the NRC's decommissioning General Design Criter on (GDC) 19' significance. Such items would not regulations were published in the could occur from a postulated transient or accident (e.g., loss of emergency core involve a raajor reduction in the level of Federal Register on July 29,1996 (61 FR cooling system, loss of control rod protection provided for public health or 39278), the licensee requested that the system). safety; therefore, they would not be review of the DP and related documents reported as abnormal occurrences. An be suspended. When the amended IL Design or Safety Analysis Deficiency, example is an event where upon final regulations became effective on August Personnel Error, or Procedural or evaluation by an NRC Incident 28,1996, the submitted DP, as Administrative Inadequacy Investigation Team, or an Agreement supplemented, became the SNEF State equivalent response, a PSDAR pursuarit to 10 CFR 50.82 as

1. Discovery of a major condition not amended. By letter dated September 30 specifically considered in the safety determination is made that the event does not meet the criteria for an 1996, the licensee discussed the effect of analysis report (SAR) or TS that requires the amended regulations on its plans for immediate remedial action. abnormal occurnmce.

Dated at Rockville, Maryland, this 13th day decommissioning the SNEF.

2. Personnel error or procedural of Decemtwr,19%. The public meeting, required by 10 deficiencies that result in loss of plant CFR 50.82(a)(4)(ii), as amended, is For the Nuclear Regulatory Commission.

capability to perform essential safety informational and will include a functions so that a release of radioactive I"h" C' ""I ** I presentation by the NRC staff on the materials, which could result in *"""'Y l 'h" C * '* *' *" decommissioning regulatory process.

exceeding the dose limits of to CFR Part (FR Doc. 96-3221n Filed 12-18-% 815 ami The licensee will give a presentation on 100 or 5 times the dose limits of 10 CFR etuwo coor 7sso-4'-* planned decommissioning activities. A l' art 50, appendix A, CDC 19, could - - - ---

- question and answer period will follow occur from a postulated transient or the presentations. Because of

[ Docket No. 50-146]

accident (e g., loss of emergency core restrictions in the license for the SNEF, I cooling system, loss of control rod GPU Nuclear Corporation and Saxton a license amendment is also needed system). Nuclear Experimental Corporation, before decommissioning activities can ill for Fuel Cycle Licenwes (Saxton Nuclear Experimental Facility); begin. This amendment to the SNEF Notice of Receipt and Availability for license will be the subject of a separate

1. A required plant shutdown as a Comment of Post Shutdown notice for public comment pursuant to result of violating a license condition or Decommissioning Activities Report to CFR 50.91.

other safety limit. and Notice of Public Meethig The SNEF PSDAR is available for

2. A major condition not specifically public inspection at the SNEF local considered in the license that requires The Nuclear Pegulatory Commission public document room, located at the immediate remedial action. (NRC)is in receipt of and is making Saxton Community I,ibrary, Front
3. An event that seriously available for public nspection and Street, Saxton, Pennsylvania 16678, and wmpromises the ability of a conunent the Post-Shutdown at the Commission Public Document wnfinement system to perform its

~

Room,2120 L Street, N.W., Washington, designated function. '"'"""k '"i '"P h * *" "* d * "d m 'S D (:. 20017. The SNEF PSDAR is filed as 40, nienon o'r mean ai mn am.'mm." mons re*

Ihe SNEF DP dated February 16.1996 IV. For Afedical Licenwes 'y"I[{'[g"j "'y Q' "l""l"; the SNEF Ibcommissioning l A medical misadministration that: p o, canns m.,nu Ensironmental Report c ted April 17, h

j-

.y r,

,i's, 1

  • fi7077 ,

! Federal Register i Vol. 61, No. m ' l'hursdan 1)ct ember 19. Im / Noti < es ,

, will he considereil for wpoit ng i as AOs gieater than the regulatory limits ic to will apply the following policy in CFR 71.'il(a)(2).

determining whether an incident or are as follows.

L.1.helt, Diversion, or 1. ors of Lu..ensed event at a facility or insolving an / I w.M En:ensres

.atedal or Sabtap or .hurhy activity that is liiensed or of herwise A. linman Exposure to Radiaoon From Hmai.h 8 regulated by the Commission is an AO within the purview of See. tion 208 of the 1.icensed Material 1. Any lost, stolen, or abandoned Energy Reorganization Act of 1974, as 1. Any unintended radiation exposure soun:es that exceed 0.01 times the Ai amended. to an adult (any individual Iil years of s alues, as listed in 10 CFR Part 71, An incident or event will he aMe of '>lder) resulting in an annual total appendix A. Table A-1, for special form considered an AO if it involves a major (sealed /nondispersible) sources, or the reduction in the de gree of prote<. tion of effeigiye dose equivalent (TEDE) of 250 sinaller of the A2 or 0.01 times the A, milhsievert (mSvl(25 reml or more: or the public health or safety. This type of an annual sum of the deep dos" values, as listed in Table A-1, for incident or event would have a equsvalent (external dose) and normal form (unsealed /dispersible) moderate or more severe impact on the smnutted dose equivalent (intake of sources or for sources for which the public health or safety and could radioactive material) to any individual form is not known. Excluded from  ;

include, but need not bo limited to the organ or tissue other than the lens of the reporting under this criterion are those following: events involving sources that are lost. l eye, bone marrow and the gonads, of g g,,.g, ,, , ,, g, 2500 mSv (250 rem) or more; or an stolen, or abandoned under the

! relicactive material licensed by or otherwise annual dose equivalent to the lens of the following conditions: sources regulated by the Commission, eye, of I Sv (100 rem) or more; or an abandoned in accordance with the (2) Major degradation of essential safety annual sum of the deep dose equivalent requirements of to CFR 39.77(ti; sealed related equipment, or and committed dose equivnlent to the sources contained in labeled. rugged ill Maior defiuenoes m design, " - I bV s urce housings; recovered sources with i f r i ren if iti s rrna (100 rem) or more; or an annual sufficient indication that doses in excess shallow-dose equivalent to the skin or of the reporting thresholds specified in Criteria by type of event used to Ao criteria I.A.1 and I.A.2 did not occur extremities of 2500 mSv (250 rem) or determ ne which mcidents orevents during the time the source was missing; will be considered for reporting as AOs more.

l and unrecoverable sources lost under are set out m appendix A of this policy 2. Any unintended radiation exposure such conditions that doses in excess of statement.

to any minor (an individual less than 18 years of age) resulting in an annual the reporting thresholds specified in A0

4. Commisuon disseminotwry of l TEDE of 50 mSv (5 rem) or mom, or to criteria I.A.1 and I.A.2 were not known potential AOand AOinformation. to have occurred.

,(a) The Commission will provide as an embryo / fetus resulting in a dose equivalent of 50 mSv (5 rem) or more. 2. A substantiated case of actual or wide a disseminatio of information to attempted theft or diversion of licensed nts 3'^"Y . radiation exposure resulted material that hasor sabotage of a facility.

I o ation on n ial A s m unmtended permanent

3. Any substantiated loss of special that may meet t AO criterial will be functional damage to an oigan or a nuclear material or any substantiated sent to the NRC Public Document Room Physiological system as determmed by a Inventory discrepancy that is judged to and alllocal ublic document rooms as physician. be signWicant relatne to nonnaHy soon as possi le after 'he staff i

B. Discharge or Dispersal of Radioactive "Pected performance, and that is

! determines that the incident is a judged to be caused b theft or diversion Material From Its Intended Place of potential AO. A Federal Register notice r by substantial bres down of th will be issued on each AO report with Confinement accountability system.

copies distributed to the NRC Public 1.The release of radioact. e matenal iv

4. Any substantial btoekdown of Document Room and all local public twhich,if an unrestricted area in concentrations physical security or material control averaged over a period of 24 document rooms. When additional information is anticipated, the notice ruurs, exceed 5000 times the values (i.e.. access control containment or l accountability systems) that

! will state that the information can be 8Pecified in Tame 2 of appendix B to 10 sigmficantly weakened the protection obtained at the NRC Public Documen CFR Part 20. unless the licensee has agamst theft, diversion, or sabotage.

l Room and in alllocal public document demonstrated compliance with

' rooms, $ 20.1301 using 520.1302 (b) (i) or D. Other Events (i.e., Those concerning (b) Each year, the Commission will 20.1302 (b)(2) (ii). Design, Analysis,Constructiort, Testing, submit a report to Congress tiding for 2. Radiation levels in excess of the Operation, Use, or Disposal of Licensed that period any AOs at or associated design values for a package, or the loss Facilities or Regulated Materials) l with any facility or activity which is of confinement of radioactive material 1. An accidental criticality llo CFR licensed or otherwise regulated resulting in one or more of the 70.52(ah,.

pursuant to the Atomic Energy Act of following:(a) A radiation dose rate of to 2. A major deficiency in design, 1954, as amended, or the Energy mSv (i rem) per hour or more at 1 meter construction, control, or operation Reorganir.ation Act of 1974, as (3.28 feet) from the accessible external amended. This report will contain the surface of a package containing "'

f grN"uIr UnNr Ior date, place, nature, and probaby radioactive material;(b) a radiation dose ,,

consequence of each AO, the cause or rate of 50 mSv (5 rem) per hour or more das.hino%w nenal securuy

causes of each AO, and any action taken on ihe accessible extemal surface of a impiications. cta med informaiian will be withheld when formally reponing these incidents i I to prevent recurrence. package containing radHctive material in nordanc* "i'h S*c' ion zoa of the t;nergy f and that meet the requirements for ""88"i" " ^ "I * ** *"""d'd' ^ "' ld Appendix A-AbnormalOccurrence classified details rosarding these incidents wou Criuria " exclusive use" as defined in 10 CFR b, ,,,,tabie to the congress. upon request. under

[ 71.47; or (c) release of radioactive Criteria by types of events used to material from a package in amounts appropriaie security arransements determine which incidents or events t

Attachrnent 3

.'. 67078 .Feder:I Register / Vol. 61. No. 245 / Thursday, December 19, 1996 / Noticos l

l having s'gnificant safety implications (a) Results in a dose that is (1) equal Decomrnissioning Activities Report

! requiring immediate remedial action. to or greater than I gray (Gy)(100 rads) (PSDAR) for tb Saxton Nuclear l

, 3. A serious deficiency in to a major portion of the bone marrow, Experimental Corporation (SNEC) management or procedural controls in to the lens of the eye, or to the gonads. Facility (SNEF) located near the major areas. or (2) equal to or greater than to Gy Borough of Saxton, in Liberty i .

4. Series of events (where individual (1000 rads) to any other organ; and Township, Bedford County, events are not of major importance), (b) Represents either (1) a dose or Pennsylvania. A public meeting on the recurring incidents, and incidents with dosage that is at least 50 percent greater SNEF PSDAR will be held in the Saxton implications for similar facilities than that prescribed in a written Fire IIall located at 8th and North (generic incidents) that create a mejor directive or (2) a prescribed dose or Street, Saxton, Pennsylvania 16678 on safety concern. dosage that (i)is the wrong January 28.1997, at 7:00 p.m.
11. For Commercial Nuclear Power Plant radiopharmaceutical,5 or (ii) is delivered Reactor operations at SNEF were by the wrong route of administration, or terminated in May 1972. The reactor is i

l (iii)is delivered to the wrong treatment defueled, with reactor fuel removed A. Malfunction of Facility. Structures, site, or (iv) is delivered by the wrong from the site, and the reactor cooling I or Equipment treatment mode, or (v) is from a leaking system is drained. SNEC submitted the I 1. Exceedin8 a safetyl imit of license source (s). SNEF Decommissioning Plan (DP) dated technical specification (TS) (S 50.36(c)l. February 16,1996 to the NRC in l V. Cuidelines for "Other Events of

2. Serious degradation of fuel eccordance with NRC regulations in i

Interest" integnty. primary coolant pressure effect at that time.The licensee boundary, or primary contamment The Commission may determine that submitted the SNEF Decommissioning boundary. events other than AOs may be ofinterest Environmental Report on April 17,

3. Ioss of plant capability to perform to Congress and the public and be 1996. On July 18 and November 8,1996, essential safety functions so that a included in an appendix to the AO the licensee submitted additional l release of radioective materials, which ,,pg ,, ..Other Events of Interest." information on the DP and could result in exceeding the dose hmits Guidelines for events to be included in environmental report in response to a i of 10 CFR Part 109 or 5 times the dose the AO report for this purpose are items request for additionalinformation from that may possibly be perceived by the the staff. When proposed amendments limats of to CFR Part 50, apcendix A.

General Design Critenon (GDC) 19, public to be of health or safety to the NRC's decommissioning significance. Such items would not regulations were published in the j could occur from a postulated transient or accident (e.g., loss of emergency core involve a major reduction in the level of Federal Register on July 29,1996 (61 FR cooling system, loss of control rod protection provided for public health or 39278), the licensee requested that the .

safety; therefore, they would not be review of the DP and related documents )

' Y S* b reported as abnormal occurrences. An be suspended. When the amended i B. Design or Safety Analysis Deficiency, example is an event where upon final regulations became effective on August Personnel Error, or Procedural or evaluation by an NRC Incident 28,1996, the submitted DP. as Administrative inadequacy Investigation Team or an Agreement supplemented, became the SNEF State equivalent response, a PSDAR pursuant to 10 CFR 50.82 as

1. Discovery of a major condition not determination is made that the event amended. By letter dated September 30, specifically considered in the safety 1996, the licensee discussed the effect of analysis report (SAR) or TS that requires does not meet the criteria for an abnormal occurrence. the amended regulations on its plans fcr immediate remedial action. Dated at Rockville, Marvland, this 3th day decommiJ,sioning the SNEF.
2. Personnel error or procedural of December,19% The public meeting, required by to deficiencies that result in loss of plant CFR 50.82(a)(4)(ii), as amended, is For the Nuclear Regulatory Commission.

, capability to perform essential safety informational and will include a f

  • i functions so that a release of radioactive presentation by the NRC staff on the materials, which could result in S*""'Y M' ", * "". .8"" decommissioning regulatory process.

exceeding the dose limits of to CFR Part IFR Doc. 96-32210 Filed 12-18-% 845 aml The licensee will give a presentation on in0 or 5 times the dose limits of to CFR mm Coo'2 m* *w planned decommissioning activities. A nri So, appendix A, GDC 19, could - question and answer period will follow occur from a postulated transient or the presentations. Because of accident (e.g., loss of emergency core (DocM No. 50-H6]

restrictions in the license for the SNEF, cooling system, loss of control rod GPU Nuclear Corporation and Saxton a license amendment is also needed system). Nucl6er Experimental Corporation, before decommissioning activities can III. For Fuel Cycle L.censees (Santon Nuclear Experimental Facility); begin. This amendment to the SNEF Notice of Receipt and Availability for license will be the subject of a separate

1. A required plant shutdown as a Comment of Post Shutdown notice for public comment pursuant to result of violating a license condition or Decommissioning Activities Report 10 CFR 50.91.

other safety limit. and Notice of Publ6c Meeting The SNEF PSDAR is available for

2. A major condition not specifically public inspection at the SNEF local ronsidered in the license that requires The Nuclear Fegulatorv Commission public document room, located at the immediate remedial action. (NRC)is in receipt of and is makmM Saxton Community Library, Front
3. An event that seriously available for public inspection and Street, Saxton. Pennsylvania 16678, and i ompromises the ability of a comment the Post. Shutdown at the Commission Public Document confinement system to perform its -

Room. 2120 L Street, N.W., Washington, designated function. ' The *'""" 'dd' Ph d * *' " a t d' "d m '4 ao rraennn ior meaua'*maaa'nnmairai.unsD reic C. 20037. The SNEF PSDAR is filed as IK for Medient beenwes the SNEF DP dated February 16.1996,

'" dg'pPh ,dy]',"'j""[g,l[',*3

, , the SNEF Ikcommissioning A medical misadministration that: pn.waurn m.mnai Ensironmental Report dated April 17,

_ _ _ _ _ _ - - N

. . . = . _ _ _ . . _ _ . _ _ __ _ _ . . . _ _ _ _ . _ . . _ _ _ _ _ ___

_ m0 Y./

,, Form NRC-489 0 76)

U. S. NUCLEAR REGULATORY COMMISSION NRC MANUAL TRANSMITTAL NOTICE CHAPTER NRC-0212 ABNORMAL OCCURRENCE REPORTING PROCEDURE ,

SUPERSEDED: TRANSMITTED:

Number Date Nurnber Date f

TN 0200-39 9/9/87 Chapter Chaper Q; ,

Page Page Appendie Appendix REMARKS:

Please make the following pen-and-ink changes to this chapter:

1. Paragraph -033.d (4) - substitute " Office of Administration and Resources Management" for " Offices of Administration".
2. Paragraph -034 - substitute " Directors of the Offices of Nuclear Reactor Regulation (NRR), Nuclear Material Safety and Safeguards (NMSS), Nuclear Regulatory Research (RES),

and Special Projects (SP), and Regional Administrators:"

for present title line.

3. Paragraph -035 - substitute " Office of General Counsel" for

" Executive Legal Director".

4. Paragraph -036 - substitute "The Director, State, Local, and Indian Tribe Programs" for "The Director, Office of State Programs".
5. Pa'ragraphs -037 and -038 - delete " Office of" in both title lines.
6. Paragraph -054.e - substitute "U. S. Government Printing Office and the National Technical Information Service" for "NRC/GPO Sales Program". -

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Attachment 2 I - -- _. .- .-_ - -- . - .

. . _ - . . . . -. .. . _ - . . . _. ~ - -~. - - - . - . . , - = . - ~ . . ~ - _ . . . . - . . . _ . . - . .

1 i .- , .- 5 .

Form NRC-489 (b76)

  • U. S. NUCLEAR REGULATORY COMMISSION NRC MANUAL TRANSMITTAL NOTICE ,

i CHAPIER NRC-0212 ABNORMAL OCCURRENCE REPORTING PROCEDURE i

SUPERSEDED: TRANSMITTED:

Number Date  !

Number Date 1 J

TN 0200- 34 7/18/84 NRC-0212 2/28/78 Chapter NRC-0212 Chapter Page Page 1

i Appendix NBC-0212 7/18/84 Appendix REMARKS:

This issuance is revised to:

1. reflect changes in organization and responsibilities within the NHC since the chapter was first published.
2. add an appendix, which provides guidance for the selection of events I and the processing proced""es for abnortnal occurrence reports and l other related items.  :

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i U.S. NUCT. EAR REGULATORY COMMISSION i

NRC MANUAL i

Volume: 0000 General Administration AE00 Par +: 0200 Administrative Procedures and Services i

i CHAPTER 0212 ABNORMAL OCCURRENCE REPORTING PROCEDllRE ,

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! 0212-01 COVERAGE )

i This chapter. and its appendix define the system for staff coordination of the l

' Abnormal Occurrence (AO) reporting process. This includes the procedures )

for identifying, evaluating, and processing the reports of events that are l considered potential AOs and Other Related Items as defined herein. This i 2

j chapter does not affect Commission rules and regulations or other require-ments applicable to NRC licensees which are given in the Code of Federal Regulations, Technical Specifications, and/or license provisions. In addition, this chapter does not affect the Commission's agreements with Agreement States, as authorized by Section 274 of the Atomic Energy Act of 1954, as y amended.

i 0212-02 OBJECTIVESe s. ~ .. ..

l 021 To provide effective communication of policies, objectives, responsi-4 bilities, authorities, requirements, guidance, and information pertaining to the j reporting of AOs and Other Related Items.

j 022 To assure that the reporting process is properly coordinated and

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consistent with provisions of Section 208, Energy Reorganization Act of 1974, 2

ss amended, and with decisions of the Commission and the Executive Director

< for Operations.

0212-03 RESPONSIBILITIES AND AUTHORITIES c

031 The Commission:

a. makes final determinations of AOs. ,

I

b. grants final approval of the quarterly- AO reports to Congress.

032 The Executive Director for Operations (EDO):

a. reviews staff recommendations of AOs and Other Related Items.

Resolves staff disagreements, if any, and forwards recommendations ,

to the Commission for final determination.

b. assures that arrangements are made for any required informal or formal Comunission briefings.

Approved: July 18, 1984

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NRC-0212-033 ABNORMAL OCCURRENCE REPORTING PROCEDURE i

l c. assures that Commission comments on staff recommendations are

~

4 resolved.

033 The Director, Office for Analysis and Evaluation of Operational Data i ( AEOD):

implements provisions of this chapter. Establishes internal proce-

}

a.

dures to assure expeditious processing of reportable items.

b. assigns a coordinator and an alternate to represent AEOD on mat-ters pertaining to AO and Other Related Items reporting.

j c. proposes and coordinates changes with the staff and Commission, as

necessary, to the reporting procedures, criteria, and guidelines for selection of events for reporting to the Commission and Congress.

i

d. coordinates with the staff and Commission events proposed by AEOD and other Offices for reporting as Aos and Other Related Items.

Assures that all reportable items receive a security review. '

i

' (1) prepares and coordinates a Commission paper and a Federal Register notice (FRN) for individual reports of potential AOs and the quarterly report to Congress.

(2) resolves staff comments and disagreements. If an ~faipbte'*ig encountered, submits supporting documentation and an AEOD recommendation to the EDO for resolution.

(3) coordinates with SECY, EDO, and the appropriate Offices for any briefings of the Commissioners.

(4) resolves Commission comments and revises reports as neces-sary. Transmits final FRNs to SECY, via EDO, for signature and publication. Arranges for the publication and distribution of the quarterly reports in conjunction with the Offices of Arhninistration and Congressional Affairs.

(5) maintains a file of supporting documentation for each event and quarterly report submitted to the Commission.

034 Directors of the Offices of Inspar tion and Enforcement (IE), Nuclear Reactor RegulaHaa (NRR), Nucl==e Material Safety and Safeguards (NMSS), and Nuclear Regulatory Re=aarG (RES); and Regional Arbainistrators:

a. implement provisions of this chapter. Establish internal procedures for expeditious identification, review, and processing of potential 1 AOs and Other Related Items.
b. assign a coordinator and an alternate to represent the Office for matters pertaining to AOs and Other Related Items. Identify these individuals to AEOD.

Approved: July 18,1984

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ABNORMAL OCCURRENCE REPORTING PROCEDURE NRC-0212-034 l

  1. c. provide information regarding potential AOs and Other Related Items I to AEOD within five and 15 working days, respectively, after

@i sufficient information has been obtained. (See a recent copy of NUREG-0090 and its associated Commission paper for format and examples. ) For each such event:

l f{.

(1) prepare a writeup and forward it to AEOD for processing.

The forwarding letter should state the specific criteria, example, and/or guideline used to select the event for i reporting. The text of the writeup should describe the circumstances leading up to the event, the event itself (including, if applicable, a description of the components and systems involved, and their functions), actual or probable l

consequences (safety issue), the immediate actions taken to mitigate the event, and the actions (immediate and long term) taken to prevent recurrence. NRC response should be des-cribed, e.g., activation of Operations Center, inspections, independent studies made, meetings, orders or license modifi-cations, enforcement actions, etc.

The cognizant office may request AEOD guidance or assistance, l . . . , ,, as resoure.es permit, in preparing draft writeups of reportable Items . 'However, in o'rder for AEOD' to '&s's ist, the cognizant i 3 S 3 c,.

l office must provide all pertinent documents (i.e. , copies of

' orders, letters to and from the NRC, inspection and enforce-ment reports, minutes of meetings, safety evaluation reports, l

enforcement letters, etc.) pertaining to the event.

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(2) provide information and assistance to AEOD during evaluation (including any Commission briefings) of the subject events.

(3) provide updating material as .he information becomes known.

d. respond to AEOD's requests for review of proposed reportable ,

l items.

For concurrences and editorial comments, telephonic or facsimile

(

responses from the Office or Regional coordinator to the AEOD i

coordinator are acceptable. For nonconcurrence of a possible AO, the response must be by formal reply, signed by the Office Director or Regional Administrator. Detailed reasons for the non-concurrence must be provided.

,e. respond to AEOD's quarterly requests for a listing and assessment

,4 of any significant items which appear reportable as potential AOs or 9 Other Related Items. The assessment (in summary form) should h include the significance of each item and reasons why it appears

. reportable. Typical significant items are:

I (1) the identification of a generic safety concern.

) (2) activation of Operations Center due to significant events re-l i ported by licensees in accordance with the Immediate Notifica-tion requirements.

Approved: July 18, 1984

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NRC-0212-035 ABNORMAL OCCURRENCE REPORTING PROCEDURE i

l (3) significant enforcement actions, i.e. , Severity I and II items;

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civil penalties; orders to cease and desist; license suspension, modification, or revocation for safety reasons; show cause orders. -

(4) orders or license modifications in response to significant security or safeguards incidents.

f. assure that the cognizant Offices are informed of items which may be potential AOs. Fo'r example:  !

(1) each Headquarters Office should inform the cognizant Regional f Offices of any event, which may be a potential AO, first >

reported by a licensee to the Headquarters Office, or of any generic issue identified by the Headquarters Office staff. The cognizant Regional Offices can then, if necessary, investigate, i gather information, and evaluate the event or issue.

(2) each Regional Office should keep the cognizant Headquarters Office informed of any event or issue which may be a potential AO.

035 The--Executive Legal-Director:

a. assigns a coordinator and an alternate to represent the Office for matters pertaining to the reporting pmcess. Identifies these indi-l viduals to AEOD.

l b. provides comments and concurrence to AEOD on incidents proposed for AO reporting and on the quarterly reports to Congress.

056 The Director, Office of State Programs:

a. assigns a coordinator and an alternate to represent the Office for matters pertaining to the reporting process. Identifies these indi-l viduals to AEOD.

l l b. assures that cognimant Regional personnel are informed of events

reported by Agreement State licensees directly to the Headquarters l

Office or of any generic issues identified by the Headquarters Office staff. Similmely, cognimant Regional personnel should assure l

that Headquarters Office personnel are kept informed of events l reported by Agreement State licensees directly to the Regional Offices, or any generic issues identified.

c. notifies AEOD within five working days of notification by an Agreement State of a proposed AO

! d. establishes internal procedures to assure expeditious processing of potential AO writeups submitted by the Agreement States. Reviews Agreement State writeups of AOs to assure they are in proper format, complete, up to date, understandable, and that the specific An ~iterion or example used is c1.carly stated.

Approved: July 18,1984

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~ NRC-0212-037- ,

ABNORMAL OCCURRENCE REPORTING PROCEDURE t

e. provides to AEOD any up' dating and/or closeout information as it becomes on  !

previously reported AOs in Agreement States l available.

1 037 The Director, Office of Public Affairs:

a. assigns a coordinator and an alternate to represent the Office for matters pertaining to the reporting process. Identifies these indivi-  !

duals to AEOD.

b. notifies AEOD of events which are receiving widespread public (more than local) interest for possible consideration as Other Events

[

of Interest.  !

038 The Director, Office of Congressional Affairs:

a. assigns a coordinator and an alternate to represent the Office for matters pertaining to the reporting process. Identifies these individuals to AEOD.
b. notifies AEOD of events which are receiving widespread Congres-sional interest for possible consideration as Other Events of l Interest.
c. notifies AEOD when the quarterly reports have been delivered to ,

Congress. AEOD will then release the report for general distri-l bution.

0212-04 DEFINITIONS 041 Abnormal Occurrence. An AO, as defined in Section 208 of the Energ" Reorganization Act of 1974, as amended, is an unscheduled incident or event which the Commission determines is significant from the standpoint of public health or safety. The criteria for such determinations are given in Part I of Appendix 0212 to this Chapter. For medical misadministrations, the AO criteria and their examples are supplemented by the specific guidelines given in Part II of Appendix 0212 to this chapter.

042 Fotential Abnormal Occurrence. Any event which appears to meet the criteria or guidelines for AO reporting.

043 Other Related Items. Other Related Items are those things that are not AOs but are discussed in the AO quarterly report or in the Commission Paper that forwards the AO quarterly report to the Commission for review and approval. Other Related Items include Other Events of Interest, and Other Updating Events Considered for Abnormal Occurrence Reporting, Material. Other Relate <'. Items also include any changes proposed to this chapter or its appendix.

044 Other Events of Interest. Any event which, though determined by

' the NRC not to be of public health significance, may be perceived as such by the public. Guidelines for selection and processing procedures for these events are given in Part III of Appendix 0212 to this chapter.

Approved: July 18,1984

1

.... .. l NRC-0212-045 ABNORMAL OCCURRENCE REPORTING PROCEDURE i

045 Other Events Considered for Abnormal Occurrence Reporting. Any event which is considered as a potential AO, but which was subsequently judged not to meet the criteria for abnormal occurrence reporting. Guidelines for selection and processing procedures for these events are given in Part IV i of Appendix 0212 to this chaptc.r.

046 Updating Material. Any new, significant information which becomes known in regard to previously reported AOs. Guidelines for processing updating material are given in Part V of Appendix 0212 to this chapter.

0212-05 BASIC REQUIREMENTS 051 Applicability. This chapter applies to and shall be followed by NRC Headquarters Offices and Regional Offices.

i' 052 Appendix. The criteria and guidelines for selection of events for possible AO reporting, and the selection and processing of Other Related Items, are contained in Appendix 0212 to this chapter.

053 _ Federal Register Notices. ,

1

a. Information concerning. AOs at NRC licensees is publicly dissemin-ated through the Federal Register, with copies sent to the NRC ,, , ,, ,j Public Document Room and to the local public document rooms. i Generally there is a Federal Register notice issued which contains the detaDs of each AO and, where additional information is antici- -

pated, the notice indicates that this information can be obtained at the Public Document Room.

b. Required minimum information for the Federal Register notice is date, place, nature and probable consequences of the event.

Subsequent information (e.g., cause and actions taken to prevent recurrence, any significant updating information) will be promul-gated either by updating summaries deposited in the public docu-ment rooms or through the quarterly reports to Congress, or both.

c. AOs at NRC licensees are to be reported to the public by issuing the Federal Register notice generally within 15 days after Commis-sion approval of the AOs.
d. A Federal Register notice is also issued upon publication and deliv-ery to Congress of each quarterly AO report. The notice lists the AOs included in the report and describes the' availability of the report.

054 Reporting Requirements.

a. Any individual, NRC Office, other government agency, licensee, or member of the public may propose an event to any NRC organha-tional unit for evaluation as a potential AO. Any such event, together with the reasons why it does or does not appear to meet the AO criteria, should then be submitted to AEOD for evaluation and processing.

Approved: July 18, 1984

~ NRC-0212-055 ABNORMAL OCCURRENCE REPORTING PROCEDURE

b. Any individual, NRC Office,' other government agency, licensee, or member of the public may recommend (to AEOD) changes in the AO reporting program, evaluation and ' determination procedures, or method of dissemination to the public or Congress.
c. In order to report AOs to the public in a timely manner, Office responses to AEOD's requests for review and comment of AOs should be submitted within five and 10 working days from the date , i of the AEOD requests, for individual AOs and for the quarterly AO reports, respectively.  ;

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d. A goal for the issuance of the quarterly AO report to Congress is 120 days after the end of each calendar quarter. The quarterly i reports are issued in the NUREG-0090 series.

After delivery of the quarterly reports to Congress, copies are sent i e.

to the NRC Public Document Room and to the appropriate local ,

public document rooms. Copies are also released for regular distri-l l bution and for purchase from the NRC/GPO Sales Program.

055 References.

l Section 208 of the Energy Reorganhation Act of 1974 (Public' Law l a.93-438, 42 U.S.C. 5848) states that the Commission shall submit to the Congress each quarter a report listing for that period any abnormal occurrences at or associated with any facility which is licensed or otherwise regulated by the NRC. For the purposes of Section 208, an abnormal occurrence is an unscheduled incident or event which the Commission determines is significant from the l

standpoint of public health or safety. Nothing in the preceding i

sentence shall limit the authority of a court to review the determi-

! nation of the Commission. Each suel, report shall contain:

(1) the date and place of each occurrence; (2) the nature and probable consequence of each occurrence; (3) the cause or causes of each; and (4) any action taken to prevent reoccurrence; l

j the Commission shall also provide as wide dissemination to the l public of the information specified in items (1) and (2) above as l

reasonably possible within fifteen days of its receiving information l

cf each abnormal occurrence and shall provide as wide dissemination i to the public as reasonably possible of the information specified in

! items (3) and (4) above as soon as such information becomes avail-l able to it.

b. The present AO criteria were submitted to the Commission on September 10, 1976, by SECY-76-471 and approved by a memoran-dum from S.J . Chilk to L.V. Gossick dated December 2, 1976.

Subsequently, these criteria were included in an NRC Policy State-ment, implementing Section 208, which was published in the Federal l

Register (42 FR 10950) on February 24, 1977.

l Approved: July 18,1984 l

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NRC-0212-055.c ABNORMAL OCCURRENCE REPORTING PROCEDURE

c. Staff ctidelines for selection of medical misadministrations as poten- l tial AOs were submitted to the Commission for approval by SECY- .

84-60 on February 3, 1984 and approved by a memorandum from l J.C. Hoyle to W.J. Dircks dated June 4,1984.

d. The Commission requirement that the memorandum submitting the draft quarterly AO reports to the Commission document a repre-
  • sentative sample of Other Events Considered for Abnormal l Occurrence Reporting is contained -in the previously referenced l memorandum from S.J. Chilk to L.V. Gossick dated December 2, 1976.
e. The Commission requirement that consideration be given to the inclusion in the quarterl; AO reports of Other Events of Inteiest is contained in the previously referenced memorandum from S.J. Chilk to L.V. Gossick dated December 2,1976. Guidelines for the selec-tion of such events were submitted to the Commission for informa-l tion by SECY 78-460A on December 1,1978.
f. The Commission requirement that Agreement States screen events and voluntarily report to NRC those occurrences that meet the i criteria established as a thrc: Sold for reporting under.Section .208, l is contained 'in a inenoran~dsm 'from
  • S'.J.' Chilk" to L.V. Gossick dated February 22, 1977. If the NRC agrees that the Agreement State events meet the AO criteria, they are to be included in the quarterly AO reports to Congress.

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I Approved: July 18, 1984

i ABNORMAL OCCURRENCE REPORTING PROCEDURE NRC Appendix 0212 l

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! CONTENTS l

Pag PART I ABNORMAL OCCURRENCE CRITERIA................................. 1 A. General Criteria............................................. 1 B. Examples of Event Types...................................... I

1. For All Licensees....................................... 1
2. For Commercial Nuclear Power Plants..................... 2
3. For Fuel Cycle Licensees................................ 3
a. For Reprocessing Facilities........................ 3
b. For All Fuel Licensees............................. 3 PART II STAFF GUIDANCE FOR SELECTION OF MEDICAL MISADMINISTRATION EVENTS FOR ABNORMAL l OCCURRENCE REPORTING......................................... 5 A. Introduction................................................. 5
8. Procedures................................................... 5 l C. Specific Guidelines.......................................... 5 D. General Guidance............................................. 6 E. Adve rs e Heal th E f f ec t s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Table 1: A0 Reporting Thresholds for Medical Misadministration Events .......................... 8 PART III GUIDELINES FOR SELECTION AND PROCESSING PROCEDURES FOR OTHER EVENTS OF INTEREST...................... 11 A. Guidelines for Selection..................................... 11 B. Processing Procedures........................................ 12

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PART IV GUIDELINES FOR SELECTION AND PROCESSING PROCEDURES FOR OTHER EVENTS CONSIDERED FOR ABNORMAL OCCURRENCE REPORTING............................ 13 A. Guidelines for Selection..................................... 13 B. Processing Procedures........................................ 13 PART V GUIDELINES FOR PROCESSING OF UPDATING MATERIAL............... 15 A. Discussion................................................... 15 l

! 1. Federal R*21 ster Notices................................ 15

2. Quarterly teports to Congress........................... 15 B. Close Out of Abnormal Occurrences............................ 15 C. Reopening of Closed Items.................................... 16 O. Processing Procedures........................................ 16 i Approved: July 18, 1984

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i ABNORMAL OCCURRENCE REPORTING PROCEDURE NRC Appendix 0212 l

PART I ABNORMAL OCCURRENCE CRITERIA A. GENERAL CRITERIA An Abnormal Occurrence (AO) is an event involving a major reduction in the degree o' protection of the public health or safety. Such an event i

would involve a moderate or more severe impact on the public health or safety and could include but need not be limited to:

1. Moderate exposure to, or release of, radioactive material licensed by or otherwise regulated by the Commission;
2. Major degradation of essential safety-related equipment; or
3. Major deficiencies in design, construction, use of, or managt.nent controls for licensed facilities or material.

B. EXAMPLES OF EVENT TYPES . .. . , . , .  ;

Examples of the types of events that are evaluated in dett'! using these l criteria are: ,

l

1. For All Licensees l
a. Exposure of the whole body of any individual to 25 rems or  !

more of radiation; exposure of the skin of the whole body of i l any individual to 150 rems or more of radiation; or exposure of the feet, ankles , hands or forearms of any individual to 375 rems or more of radiation (10 CFR $ 20.403(a)(1)), or equivalent exposures from internal sources.

b. An exposure to an individual in an unrestricted area such that the whole body dose received exceeds 0.5 rem in one calendar year (10 CFR $ 20.105(a)).

- c. The release of radioactive material to an unrestricted area in concentrations which, if averaged over a period of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, exceed 500 times the regulatory limit of Appendix B, Table II, 10 CFR Part 20 (10 CFR $ 20.403(b)).

d. Radiation or contamination levels in excess of design values on -

packages, or loss of confinement of radioactive material such i as (1) a radiation dose rate of 1,000 mrem per hour three feet l

- from the surface of a package containing the radioactive material, or (2) release of radioactive materal from a package in amounts greater than the regulatory limit (10 CFR l

! $ 71.36(a)).

i 1 Approved: July 18, 1984 l

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  • NRC Appendix 0212 Part I ABNORMAL OCCURRENCE REPORTING PROCEDURE l e. Any loss of licensed. material in such quantities and under I

such circumstances that substantial hazard may result to r

persons in unrestricted areas.

l l f. A substantiated case of actual or attempted theft or diversion  !

l of licensed material or sabotage of a facility,

g. Any substantiated loss of special nuclear material or any substantiated inventory discrepancy which is judged to be sig-nificant relative to normally expected performance. and which is judged to be caused by theft or diversion or by substantial breakdown of the accountability system.
h. Any substantial breakdown of physical security or material control (i. e . , access control, containment, or accountability systems) that significantly weakened the protection against theft, diversion or sabotage.
i. An accidental criticality (10 CFR 6 70.52(a)).
j. A major deficiency in design, construction, or operation having safety implications requiring immediate remedial action.
k. Serious deficiency in management or procedural controls in major areas. ,
1. Series of events (where individual events are not of major importance), recurring incidents, and incidents with implica-tions for similar facilities (generic incidents) which create major safety concern.
2. For Commercial Nuclear Power Plants
a. Exceeding a safety limit of license Technical Specifications (10 CFR $ 50.36(c)).
b. Major degradation of fuel integrity, primary coolant pressure boundary, or primary containment boundary.
c. Loss of plant capability to perform essential safety functions such that a potential release of radioactivity in excess of 10 CFR Part 100 guidelines could result from a postulated transient or accident (e.g., loss of emergency core cooling system, loss of control rod system).
d. Discovery of a major condition not specifically considered in  ;

the Safety Analysis Report (SAR) or Technical Specifications j

that requires immediate remedial action.

1

e. Personnel error or procedural deficiencies which result in loss of plant capability to perform essential safety functions such that a potential release of radioactivity in excess of 10 CFR t

Approved: July 18,1984 2

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NRC Appendix 0212 Part 1 ABNORMAL OCCURRENCE REPORTING PROCEDURE Part 100 guidelines could result from a postulated transient or accident (e.g., loss of' emergency core cooling system, loss of control rod system).

3. For Fuel Cycle Licensees
a. For Reprocessing Facilities (1) A safety limjt of license Technical Specifications is ex-ceeded and a plant shutdown is required (10 CFR t

9 50.36(c)).

(2) A major condition not specifically considered in the Safety Analysis Report or Technical Specifications that requires immediate remedial action.

b. For All Fuel Licensees An event which seriously compromised the ability of a confine-ment system to perform its designated function.

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' NRC Appendix 0212 i ABNORMAL' OCCURRENCE REPORTING PROCEDURE PART II STAFF GUIDANCE FOR SELECTION OF MEDICAL MISADMINISTRATION EVENTS FOR ABNORMAL OCCURRENCE REPORTING A. INTRODUCTION The existing NRC policy statement for determination of abnormal 1 occurrences (AOs), as published in the Federal Register on February 24 l l

1977 (43 FR 10950), was developed before the requirements (10 CFR 9 35.41-35.45) for licensees to report medical misadministrations . to the NRC became effective. Few of the examples in the policy statement I l

for' AO reporting are applicable to medical misadministration events.

Therefore, for the latter events, a set of Guidelines has been developed which augment the policy statement examples. These Guidelines are l delineated below.

B. PROCEDURES , . , , J p' -

o - - . .., . ..

The staff should select medical misadministration events as potential AOs l using both the NRC policy statement for AOs, and the Guidelines below.

l The cognizant Regional or Headquarters office should prepare an AO

! writeup and forward it (together with the specific policy statement and/or Guideline example which is applicable) to AEOD for review and staff coordination. Subsequently, AEOD will forward those events that 1

.l appear to meet the AO reporti5 threshold to the Commission for '

approval as AOs . The' Commission paper will inform the Commission which specific policy statement and/or Guideline example is applicable.

If a report is based only on a Guideline example, the writeup will state that the event is being reported under the general criterion for AO determinations (i.e. , an event involving a major reduction in the degree l

i of protection of public health or safety).

C. SPECIFIC GUIDELINES Table i shows types of events which typically qualify for possible reporting as AOs; these supplement the examples (e.g., serious deficiency in management or procedural controls in major areas) described in the NRC policy statement for AOs. The first column describes various types'of medical misadministrations. Items 1 through 5 l are based on misadministrations reportable per 10 CFR $ 35.41, while items 6 and 7 refer to recurring and generic medical misadministrations, respectively. The second and third columns of Table I show the AO reporting threshold for each type of event described, for diagnostic and therapeutic exposures, respectively. A conservative approach should be

' used (i.e. , even events considered to be marginal should be proposed to AEOD for reporting). " Adverse health effects" is defined in Paragraph E below.

5 Approved: July 18,1984 l

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  • NRC Apper. dix 0212  ;

Part II ABNORMAL OCCURRENCE REPORTING PROCEDURE . ,

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In Table 1, " adverse health ' effects" has a special meaning consistent with " adverse health effects worse than expected." The former refers to events in which a person, or a specific part of the body, receives radiation when no radiation was supposed to have been given to that person or that specific part of the body. The latter refers to events in which a person, or a specific part of the body, is scheduled to receive radiation, but the actual radiation received is greater than scheduled .

and causes observable health effects worse than would have been expected for the ranges of radiation norinally associated with the parti-cular diagnostic or therapeutic procedure. Therefore, the former is a special case of the latter, in which the " expected". health effect is zero. ,

Of course, the actual doses received would also have to exceed the limits l described in 10 CFR S 35.41, since otherwise the events need not be reported by the licensee to the NRC.

The health effects on a patient may be described in the licensee's l report, which would facilitate use of these Guidelines. Occasionally, l additonal information may need to be requested from the licensee. At times, a recommendation for reporting an AO may involve reviewing the NRC's medical consultant's report, if the NRC has requested a medical consultant to review the event. Established medical literature can also u , ,

be used in determining an. adequate basis for . reporting. _ , . _ _,

l D. GENERAL GUIDANCE l

i 1. Reports are to be consistent with the provisions of the Privacy Act and the Freedom of Information Act.

2. Drug defects, adverse drug reactions, or other problems outside l the purview of the NRC will not generally be included.
3. In some cases, a collection of events may be presented in a report as a summary of specific data. For example, for similar events (such as recurring events or a series of events), the date and place, nature and probable consequences, cause or causes, may be presented in a table of data; the corrective actions to prevent recurrence could then be presented collectively in more detail.

7 '

l E. ADVERSE HEALTH EFFECTS Adverse health effects are acute symptoms directly . related to various l levels of radiation such as death; vomiting; erythema; diarrhea; fatigue; l

epilation; reduction in lymphocytes, platelets, and/or total white blood count; lesions and/or other tissue breakdown or damage. Whether or i not the problems can be controlled, alleviated, or halted by further l medical treatment is not germane for the purposes of defining an AO.

Even for prescribed amounts of radiatia, some adverse health effects l may occur or may be expected to occur. When a person or a part of the j body receives radiation exceeding the limits normally prescribed for' that

diagnostic or therapeutic procedure, and the event is reportable by the
licensee under 10 CFR 9 35.41, only the adverse health effects which i

Approved: July 18, 1984 6

'NRC Appendix 0212 l Part II -

ABNORMAL OCCURRENCE REPORTING PROCEDURE exceed those expected by the limits of the diagnostic or therapeutic procedure are considered for AO reporting. However, as described l

previously, when a person or a part of a' body receives radiation (but n:ne was prescribed for that person or part of body), any observable l

l adverse health effects form a basis for AO reporting. The licensee's followup and/or NRC's medical consultant's report, and established l

medical literature, will generally provide the basis fer necessary l

Judgments.

Many prescribed procedures involving radiopharmaceuticals or sealed sources, even though targeted primarily for a particular part of the body, will also subject other parts of the body to radiation exposure.

The latter parts of the body must also be considered when applying the i Specific Guidelines.

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  • - NRC App:ndix 0212 Part II ABNORMAL OCCURRENCE REPORTING PROCEDURE j Table 1 AO Reporting Thresholds for Me, dical Misadministration Events AO Reporting Threshold Event Type Diagnostic Exposure Therapeutic Exposure (1) Administering a If the improper admin- If the improper admin-radiopharmaceutical istration results in istration results in or radiation from a any part of the body my part of the body sealed so2rce other receiving unscheduled receiving unscheduled than the one intended, radiation, an AO report radiation, an AO report See 10 CFR 6 35.41.(a). should be proposed if: should be proposed for any such event.

(a) the actual dose to the wrong body If the parts of the ,

part is greater body receiving radiation i than five times improperly would have i the upper limit received radiation j of the normal anyway, had the proper l range of expo- administration been used,  ;

sures prescribed an AO report should be  ;

for diagnostic proposed if:  !

procedures invol-r!;g that body (a) the actual dose is ph t, or greater than 1.5 times that intended to the j (b) there are clinical above described body i indications of a_ny parts, or adverse health effects to the (b) the actual dose is less I wrong body part. than 0.5 times that intended to the above If the parts of the described body parts, or, body receiving radiation improperly would have (c) the above described received radiation body parts show signs anyway, had the proper of adverse health effects administration been used, greater than expected an AO report should be had the proper adminis-proposed if: tration been used, or (a) the actual dose is (d) the event (regardless greater than five of any health effects) times that intended affects two or more to the above patients at the same described body facilf ty.

parts, or, Approved: July 18, 1984 8

.. .- - . - . - - - - - - - - - . . - . ~ . .- .- , .-- --

1

. NRC Appendix 0212

1 Part II ABNORMAL OCCURRENCE REPORTING PROCEDURE Table 1 (Continued) l 1

AO Reporting Threshold '

Event Type Diagnostic Exposure Therapeutic Exposure (b) the above described body parts show signs l

of adverse health effects greater than j

j expected had the proper administration been used.

(2) Administering a An AO report shoulu be An AO report should be radiopharmaceu- proposed if: proposed for any such tical or radiation event.

to +he wrong (a) the actual dose to pauent. See the wrong patient 10 CFR S 35.41(b). exceeds five times the prescribed ,

dose for the intended patient, of (b) the event results in

_anl adverse health effects .

(3) Administering a Same guidelines as for Same guidelines as for radiopharmaceu- Event Type 1. Event Type 1.

tical or radiation by a route of administration q other than that intended by the pretcribing physician. See 10 CFR S 35.41(c)

(4) Administering a An AO report should Not applicable.

be proposed if:

diagnostic dose of a radiopharm-aceutical differ- (a) the actual dose is ing from the greater than five prescribed dose times the prescribed -

by more than 50 dose, of ,

percent. See 10 CFR S 35.41(d). (b) the event results in adverse health effects >

worse than expected for 9 Approved: July 18, 1984

e . NRC Appe.idix 0212
' Pcrt II ABNORMAL OCCURRENCE REPORTING PROCEDURE

) Table 1 (Continued)

AO ~ Reporting Threshold

Event Type Diagnostic Exposure Therapeutic Exposure s

! the normal range of i exposures prescribed j for the diagnostic

procedure.

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(5) Administering 'a Not applicable. An AO report should be 7

therapeutic dose proposed if:

i of a radiophar-maceutical dif- (a) the actual, dose is i fering from the greater than 1.5 times prescribed dose the prescribed dose, or,

by more than 10 percent; or (b) the actual dose is i administering a less than 0.5 times the therapeutic prescribed dose, or
radiation dose

! from a sealed (c) the event results in

source such that adverse health effects 4 errors in the worse than would be source calibration, expected for the nors i time of exposure, range of exposures
and treatment prescribed for the  ;

j geometry. result in therapeutic procedure, or, j

a calculated total i treatment dose (d) the event (regardless

! differing from the of any health effects) 4 final prescribed affects two or more {

f total treatment patients at the same  !

dose by more than facility.

10 percent. See 10 CFR $ 35.41(e) i and (f).  !

(6) Recurring or. For either diagnostic or therapeutic exposures, an serier of events AO report should be proposed for recurring events (regardless of or a series of events (where each individual misad-  !

the number of ministration is not of major importance) which patients or create a significant public health or safety concern, facilities 4 involved).

(7) Generic events. For either diagnostic or therapeutic exposures, an AO report should be proposcd for misadministrations with generic implications which create a significant i public health or safety concern.

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Approved: July 18, 1984 10

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ABNORMAL OCCURRENCE REPORTING PROCEDURE NRC Appendix 0212 i

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l PART III GUIDELINES FOR SELECTION AND PROCESSING PROCEDURES I FOR OTHER EVENTS OF INTEREST A. GUIDELINES FOR SELECTION .  ;

1 These events will be chosen for recommendation to the Commission based  ;

upon one or more of the following guidelines.

i 1. Non-routine events which have attracted wide (more than local) ,

l public interest (e.g. , events resulting in petitions to the Commis-

sion by public interest groups, generic events which have resulted i in power reductions or shutdowns for safety-related reasons, or widespread media coverage). Widespread media coverage generally means that the event has been disseminated by a national news service.
2. Non-routine events which have attracted considerable Congressional l interest.
3. Inventory differences which exceed the AO reporting threshold when first reported by the licensee, but which are reduced to an acceptable level by a subsequent inventory. (If they cannot be so ,

~

reduced, they are candidates for AO reporting.)

4. Events at nuclear power plants under construction and with no fuel j on site, which would have qualified as an AO if the facility had an l operating license.

l S. Non-routine events of the following types, or events of equivalent importance, which are either considerably more extensive than expected or the result of an unexpected cause, but which are below the AO reporting threshold:

a. Exposures (either plant personnel or public),
b. Radioactive releases (e.g. , contamination of individuals, wide-spread contamination within the site boundaries, releases to unrestricted areas),

l c. Failures of systems designed to contain radioactive material j (e.g., fuel cladding, primary coolant boundary, containment boundary, glove boxes, dams),

d. Failures of systems designed to control the radioactive process i and/or to mitigate accident consequences, y e. Design or operational problems requiring considerable

! corrective actions and/or shutdown time, 11 Approved: July 18,1984

> ~ NRC App:ndix 0212 '

c- Part III ABNORMAL OCCURRENCE REPORTING PROCEDURE .

f. Shipping problems, pr
g. Safeguards problems.

B. PROCESSING PROCEDURES

1. Those events which appear to meet these guidelines for reporting should be written up by the cognizant office in a narrative format.

The information should include pertinent details of the event, including the date and place, nature and probable consequences, causes, licensee and NRC actions. Also, the reasons why it is not an AO should be clearly stated. See a recent copy of NUREG-0090 for format. This writeup should be forwarded to AEOD, as soon as it is completed, rather than waiting until the end of the quarter.

This should help to decrease the time required to prepare, process and submit the quarterly reports to the Commission for approval.

As discussed in Paragraph 034 of Chapter 0212, the cognizant office ,

may request AEOD guidance or assistance, as resources permit, in preparing event writeups provided all related documentation i

regarding the event is supplied to AEOD.

2. AEOD will review and edit the writeup and request assistance as necessary from other offices to assure accuracy and timeliness of the writeup. The event will be proposed to the Commission for l

inclusion in the next quarterly AO report to Congress.

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w f ABNORMAL OCCURRENCE REPORTING PROCEDURE NRC Appendix 0212 l t PART IV

! GUIDELINES FOR SELECTION AND PROCESSING PROCEDURES FOR '

OTHER EVENTS CONSIDERED FOR ABNORMAL OCCURRENCE REPORTING l A. GUIDELINES FOR SELECTION i By definition, these are events which were considered as AOs but l rejected after further reviews. (If rejected as Aos, they should then be evaluated for possible reporting a1, Other Events of Interest). Such l

events would include:

1. Any event reviewed in detail and seriously considered by one or i

more of the staff offices for AO applicability, but eventually l rejected by that office or offices.

f 2. Any event determined by one or more staff offices to meet the AO criteria and forwarded to AEOD for processing, but eventually rejected after staff considerations.  !

l These items are included as an enclosure to the Commission papers for-l warding the draft quarterly AO reports to the Commission for approval; '

l the items are not included in the AO reports, unless stipulated otherwise by the Commission. l B. PROCESSING PROCEDURES

1. Those events or items which appear to meet these guidelines for reporting should be written up by the cognizant office in a format similar to that for Other Events of Interest items. The information i

i should include pertinent details of the event, including the date and place, nature and probable consequences, causes, licensee and NRC actions.

Also, the reasons why it is not considered an AO or Other Events of Interest item should be clearly stated either at the end of the  :

  • text or'in a transmittal memo. This writeup should be forwarded to AEOD as early as possible during the calendar quarter and no later i than 15 days after the end of the calendar quarter in which the event occurred, provided sufficient information is available.

As discussed in Paragraph 034 of Chapter 0212, the cognizant office may request AEOD guidance or assistance, as resources permit, in

, preparing event writeups provided all related documentation

  • .regarding the event is supplied to AEOD.

! 2. AEOD will review and edit the writeup and request assistance as i necessary from other offices to assure accuracy and timeliness of the writeup. The event will be considered for inclusion in the 13 Approved: July 18, 1984 L

  • NRC App:ndix 0212 Part IV ABNORMAL OCCURRENCE REPORTING PROCEDURE -

Commission paper forwar' ding the next quarterly AO report for approval.

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ABNORMAL OCCURRENCE REPORTING PROCEDURE NRC Appendix 0212 -

l. PART V GUIDELINES FOR PROCESSING OF UPDATING MATERIAL 1

A. DISCUSSION Updating material to previously reported AOs is required for the following, j i

! 1. Federal Register Notices. As described in Paragraph 053 of i

, Chapter 0212, the minimum information to be reported in the Federal

! Register notice is the date, place, nature and probable consequen- 1 l

ces of the event. Subsequent information (cause and actions taken ]

to prevent recurrence, and any significant updating information) will be promulgated either by updating summaries deposited in the  !

public document rooms or through the quarterly reports to Congress, or both.  ;

l

2. Quarterly Reports to Congress. In addition to the updating infor- '

mation described above, the quarterly reports should include any l significant updating material for previously reported AOs. In the l quarterly reports, the text for each new and updated AO .should I state whether or not the incident is considered closed for purposes of the report. In succeeding quarterly reports, efforts should be made to keep each open item current.

i B. CLOSE OUT OF ABNORMAL OCCURRENCES i

l Close out of AOs is generally appropriate under one or more of the following conditions.

1. The affected licensees have taken satisfactory corrective actions.
2. A civil penalty has been paid, or otherwise resolved.
3. A revoked or suspended license has either been reinstated or the

, licensee decides not to contest the action.

4. An item , such as a generic item, becomes an unresolved safety issue and will be reported upon periodically to Congress l accordingly.

l S. A safety analysis report or other long-term evaluation is complete l and appropriate implementing actions have been made.

j 6. No new significant information can reasonably be expected.

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i i 15 Approved: July 18, 1984

- - , - , , - --4 .- - - - - . ,,,e

s, NRC App:ndix 0212 Part V ABNORMAL OCCURRENC". REPORTING PROCEDURE C. REOPENING OF CLOSED ITEMS' AOs that have been previously reported closed in the quarterly reports i should be reopened if significant new information becomes available. I Similarly, previously reported Other Events of Interest items can be updated if significant new information becomes available.

D. PROCESSING PROCEDURES I

Each cognizant office should provida AEOD with any known significant )

updating material, (1) as soon as the information is available for AOs I reported by Federal Register notice as described in Paragraph A.1 above  !

and, (2) in the cognizant office's response to AEOD's memorandum issued l near the end of each calendar quarter requesting staff assistance for the l preparation of that quarterly report to Congress.

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120555004195 1 19A19BL9C1901 '

L'S NRC

! OtM i

L(MM) BACHRACH i MNBB-7602 l WASHINGTON OC 20555 1

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l-Approved: July 18, 1984 16