ML20134B430

Informs of Final Policy Statement Covering AO Repts Published in Fr

ML20134B430
Person / Time
Issue date:	01/17/1997
From:	Bangart R NRC OFFICE OF STATE PROGRAMS (OSP)
To:	GENERAL, MASSACHUSETTS, COMMONWEALTH OF, OHIO, STATE OF, OKLAHOMA, STATE OF, PENNSYLVANIA, COMMONWEALTH OF
References
SP-97-003, SP-97-3, NUDOCS 9701300091
Download: ML20134B430 (2)

Text

, ALL A2REEMENT STATES 03 4 1 7 LQ37 MASSACHUSETTS, OHIO, OKLAHOMA, PENNSYLVANIA TRANSMITTAL OF STATE AGREEMENTS PROGRAM INFORMATION (SP 003 )

Your attention is invited to the attached correspondence which contains:

INCIDENT AND EVENT INFORMATION............ XX REVISED ABNORMAL OCCURRENCE CRITERIA PROGRAM MANAGEMENT INFORMATION.......

TRAINING COURSE INFORMATION.................

TECHNICAL INFORMATION........................ ..

OTH E R I N FO R M ATI O N. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

e This letter is to inform you that the final policy statement covering abnormal occurrence

' (AO) reports has been published in the Federal Reaister. Vol. 61, No. 245, December 19, 1996 (copy' enclosed), and is effective as of December 19,1996.

Also enclosed is a copy of the November 7,1996, Cornmission Staff Requirements Memorandum (SRM) response to the Staff Requirements-SECY 96-193, Abnormal Occurrence Reports: Implementation of Section 208 Energy Reorganization Act of 1974, Final Policy Statement. The SRM contains direction to staff to " file incident information on potential AOs in the Public Document Room's (PDRs) as soon as possible after the staff determines that the incident is a ootential AO because it may meet the AO criteria."

If you have any questions regarding this correspondence, please contact me or the individual named below.

POINT OF CONTACT: Patricia M. Larkins TELEPHONE: (301) 415-2309 ,

FAX: (301) 415-3502 Odginal signed By RICHARD L. BANGART Richard L. Bangart, Director Office of State Programs

Enclosures:

As stated Distribution:

DIR RF (Assigned 11/12/96) DCD (SP03) /

RLB:ngart PLohaus POR (YES_X_ NO_)

Il SDroggitis RSOAs ) E-Mailed PLarkins

/

RSLOS 1 1/17/97 HKarrgiannis, AEOD CERossi, AEOD Afg pii,~ 9701300091 9701'17 AO File PDR STPRG ESGG DOCUMENT NAME: G:\pmlyP97003.PL /

n h,. e n ., ini. 4 4 . inac.i. in in. n. : cwpH wahout .u. chm.nt/.ncio.ur. ,;r copy with .tt.chen.nt/.nclosur. 'N' = No copy OFFICE w O,$P, f 7,W T5 O$ $ OSP:D(/ 1 l NAME ' ~PMikrlins:ndb PML'ofiaus R'LBanh#rtl

DATE 01/15/97 01/))97 01//Q/97 OSP FILE CODE: SP-A-4, SP-A-1 hhh l

n

.. .. , en p- UNITED STATES i# ..j ' NUCLEAR REGULATORY. COMMISSION-WASHINGTON, D.C. 2006H001 '

,, January 17,1997 ALL AGREEMENT STATES MASSACHUSETTS, OHIO, OKLAHOMA, PENNSYLVANIA

~ TRANSMITTAL OF STATE AGREEMENTS PROGRAM INFORMATION  !

(SP-97 003) '

I Your attention is invited to the attached correspondence which contains:

INCIDENT AND EVENT INFORMATION............. XX- REVISED ABNORMAL OCCURRENCE CRITERIA 3 PROGRAM MANAGEMENT INFORMATION........

I TRAINING COURSE INFORMATION..................

TECHNICAL I NFO R MATIO N....... ..... .................

OTH E R I N FO R MATI O N. .. .. . . . .. . . .. ... . . ... . . . . . . . ... . . ..  !

This letter is to inform you that the final policy statement covering abnormal occurrence (AO) reports has been published in the Federal Reaister, Vol. 61, No.-245, December 19, 1996 (copy enclosed), and is effective as of December 19,1996.

Also enclosed is a copy of the November 7,1996, Commission Staff Requirements Memorandum (SRM) response to the Staff Requirements SECY 96-193, Abnormal Occurrence Reports: Implementation of Section 208 Energy Reorganization Act of 1974,

Final Policy Statement. The SRM contains direction to staff to " file incident information on potential AOs in the Public Document Room's (PDRs) as soon as possible after the staff determines that the incident is a ootential AO because it may meet the AO criteria."

If you have any questions regarding this correspondence, please contact me or the individual named below.

POINT OF CONTACT: Patricia M. Larkins -

TELEPHONE: (301) 415-2309 FAX: (301) 415-3502 Riclar

( .Qf, Bangar ,Iirector f VL 4A +

Office of State Programs ~ /  !

4

Enclosures:

As stated I

t- -, _- ,c -.e_.

9

/ UNITED STATES

/ , NUCLEAR REGULATORY COMMISSION g g WA%pON, D C. 20555-0001

/ 96 NOV $fM: },4 e....* 1996 cFFICE OF THE SECMETARY MEMORANDUM TO: James M. Taylor Exec 've Di ctor for Operations FROM: John . Hoyl , etary

SUBJECT:

STAFF REQUIREMENTS - SECY-96-193 - ABNORMAL OCCURRENCE REPORTS: IMPLEMENTATION OF SECTION 208 ENERGY REORGANIZATION ACT OF 1974; FINAL POLICY l

The Commission has approved publication of the final Policy i statement on " Abnormal Occurrence Reports: Implementation of l Section 208 Energy Reorganization Act of 1974; Final Policy i Statement" subject to the changes noted in the attachment. Also, throughout the policy statement, all uses of the term " nursing infant" should be replaced with " nursing child."

-(GDG) (AE0D) (SECY Suspense: 12/13/96) 9100142 The staff should file incident information on potential abnormal i occurences (AOs) in the Public Document Rooms (PDRs) as soon as 1 possible after the staff determines that the incident is a l potential AO because it may meet the AO criteria. The staff should not wait until an AO detemination is made by the Commission, once a year, to make the incident information i available tu the public through the PDRs. In following this i direction, the staff should place already-existing documents on '

these incidents in the PDRs and identify the incident as a ,

potential AO. Preliminary Notifications, press releases, or morning report information filed in the PDRs will satisfy this directive. The staff should not develop lengthy, new documents for the PDRs on each incident to satisfy this Commission direction. Instead, the intent is to make information on major incidents immediately available to the public and categorized as potential AOs in advance of a final Commission decision, with minimal resource impact on the staff.

SECY NOTE: THIS SRM, SECY-96-197, AND THE VOTE SHEETS OF ALL COMMISSIONERS WILL BE MADE PUBLICLY AVAILABLE 5 WORKING DAYS FROM THE DATE OF THIS SRM.

]{jf4y /SUU mDr f

. . - . . . . .. . - . _. . - ~

The staff should begin to develop conforming changes to the final -

AO policy statement to cover fuel cycle facilities that may receive NRC certification. Specifically, the staff should determine whether modifications to criteria III., "For Fuel Cycle Licensees," are necessary to explicitly include fuel cycle facilities that are not licensed but are otherwise regulated such as the gaseous diffusion plants (GDPs). These conforming changes should be in place if and when NRC accepts jurisdiction for the GDPs.

4EDGF (AE0D/NMSS) (SECY Suspense: 3/3/97) 9600172 Following issuance of the FY 1997 AO report to Congress (in early 1998), the staff should report to the Commission on how NRC will -

identify unintended medical radiation exposures to an embryo / fetus or a nursing child and describe the staff's experience with voluntary reporting. In the staff's report, the i' staff should address whether the final AO policy criteria should be revised to omit reference to these types of incidents, if the staff does not recommend a mechanism to identify unintended medical radiation exposures to an embryo / fetus or a nursing child.

-(eDet (RES/AE0D/NMSS) (SECY Suspense: 3/13/98) 9600173

Attachment:

As stated cc: Chairman Jackson Commissioner Rogers Commissioner Dicus Commissioner Diaz Commissioner McGaffigan OGC OCA OIG Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail) n g>

15 i

Response: The revised criteria were presented to ACMUI and coments received l were incorporated before publishing them in the Federal Register (January 9,  !

1996: 61 FR 661). Bec=0 cQnly minor changes have been made to the criteria since ACMUI's revieWI--t.. ......,..... . .. . ,, .. . ..... .. . .. ...,

for fCMUI tc further c = fr. the criteric.

Coment: Add a third condition to the medical A0 criteria to read: "and (c) is a radiation exposure that has resulted in unintended permanent functional damage to an organ or a physiological system as determined by a physician" to eliminate reporting events to Congress that do not have any medical significance.

Response: The NRC believes that the dose thresholds of the revised criteria have sufficient margin included to limit the reporting of insignificant events. In addition, the NRC considers it important to report events that -

have the ootential to result in adverse public health and safety. The inclusion of the recommended criterion would preclude reporting of these events. Therefore, the NRC does not intend to include the proposed language.

Coment: Insignificant medical events have been included in the past A0 reports to Congress.

Response: The NRC understands the commenters' concerns with the implementation of the medical A0 policy before the revision. Because of the low dose thresholds established in the previous criteria, medical events that have not had the potential to result in significant radiation consequences to l

l l

i I

I i

e _ _ _ _ _ _ .._ ___ . _ _ _ _ _ _ _ _ _ _ .

4 19

' setting, as a patient who was not intended to receive a prescribed dose, or as

.a member of the public.  ;

l Coment: Three States suggested providing credentials for a " physician" as listed in criterion I.A.3. l Response: For general purposes the term " physician" is defined in 10 CFR Part 35.2, where " Physician means a medical doctor or doctor of osteopathy licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine."

Although the NRC regulations do not specify the detailed credentials of a " physician" for incident evaluation purposes, the NRC staff has developed an NRC Inspection Manual Chapter (IMC 1360) "Use of Physicians and Scientific Consultants in the Medical Consultant Program" that lict a group of

, j physician: that the NRC staff my obtm,n :: p....

.n

..rovj .... . .,.d,,, h...emsejo

,.. ddi?gD]da.... ncelo ,. .. .+ ,f  :

NRC consultants in case of an incident. 16[idditidiE@C]5fifff hh5TdeVil o. -p_s..d.. ,

$CiMaiiadeMQRDjf5dMyE]8110CNRClHediEaliEishQ5fdisiiisntIProgram%f6 ,

enssteXims]iah66dipfehedsfj@f Vi$ZofmidMil@idntQ The NRC :t:ff h:

revic;cd the credenti:10 of the c phy:ician and h:: determined that they have the experti:0 in- $ccialized cre : using byproduct =teri:1 for the evaluation of radiction consequences. The In pection Manual 1: IKjl360]shdM55bekht Directfi(8110? pts available in the NRC public document room, 2120 L Street, ,

j NW. (Lower Level), Washington, DC 20555-0001.

l 1  ;

4 I

I i

l i

l 22 \

l unintended radiation exposures include any exposure to a nursing irf=t @)), l fetus, or embryo as a result of an exposure (other than an occupational

exposure to an undeclared pregnant woman) to a nursing mother or pregnant )

i woman bb6f G R Jf M @ @ .

j 1 j

• 3. Abnormal occurrence aeneral statement of oolicy. The Commission ,

will apply the following policy in determining whether an incident or event at a' facility or involving an activity that is licensed or otherwise regulated by

the Comission is an A0 within the purview of Section 208 of the Energy Reorganization Act of 1974, as amended.

An incident or event will be considered an A0 if it involves a major reduction in the degree of protection of the public health or safety. This '

I type of incident or event would have a moderate or more severe impact on the l d

i public health or safety and could include, but need not be limited to the following:

l

, (1) Moderate exposure to, or release of, radioactive material licensed ,

l by or otherwise regulated by the Comission;  :

. (2) Major degradation of essential safety-related equipment; or i (3) Major deficiencies in design, construction, use of, or management controls for licensed facilities or material, i Criteria by type of event used to determine which incidents or events will be considered for reporting as A0s are set out in appendix A of this

. policy statement.

t

~

l l

l 67072 Federal Register / Vol. 61, No. 245 / Thursday, December 19, 1996 / Notices l

Certificates Offered Criteriafor the Skill Standards Commission will use in submitting the l Although there is the potential for In rder to qualify fo. Board annual abnormal occurrence (AO) l three lovels of knowledge and skills' endorsement, the skill standards system reports to Congress and the public in a i recommended by the voluntary timely manner as stated in Section 208 there will be only two types of pannerships (or the outside groups in of the Energy Reorgamzation Act of certificates: a basic certificate will encompass either the core alone (if there the case of the specialties) will have to 1974, as amended. The AO policy l meet the foilwi :g criteria (in addition statement has been revised to provide are no concentrations) or the core Pl us

, to other criteria specified in the mom specific cntena for determining one concentration certificate level, will cover the a specialt{ National Skill Standards Act)'. those incidents and events that the and leve specialty

• Follow a common nomenclature Commission considers significant from of knowledge and skills. A voluntary the standpoint of public health and partnership could establish basic identified by the Board',

. Describe in clear terms the critical safety for reporting to Congress, and to artificates for up to six concentrations. 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 establish the standards for the basic

• Describo the academic, revised AO criteria contain more certificate (s), which will then be employability, and occupational discrete reporting thresholds making

+ endorsed by the NSSB ifit meets the them easier to use and ensurmg more

' )

knowledge and ski!!s necessary to i

, 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 i accredited educational institutions and

• Adhere to statutory requirements Commission. [,  !

training providers, and recognized and Board policy on assessment; EFFECTWE DATE: December 19,1996.  ?

third. party assessment groups) will . De consistent with civil rights law: ADDRESSES:The proposed policy j l recommend the standards for specialty

• ht r exceed the highest statement published in the Federal  ?

y certificates. These groups will present applicable standards used in the United Register (January 9,1996: 61 FR 661),

standards for prospective specialty States, including registered and the comments received may be s I certificates to the voluntary partnerships apprenticeship standards; examined at the NRC Public Document l for review and endorsement, in the e De benchmarked to the best Room,2120 L Street, NW. (Lower int a 0na and same manner that the voluntary . 9, ) n :and ""' ** " E' "'

partnershi s will present standards for . Include a plan for!he updating and FOR FURTHER INFORMATION CONTACT: , j baric certi icates to the NSSB for mview continuous improvement of standards liarriet Karagiannis, Office for Analysis  ; j and endorsement. and Evaluation of Operational Data U.S.  ; '

and certificates.

Nuclear Regulatory Commission, In their review of prospective These criteria will pertain to all three Washmgton, DC 20555, telephone: (301)

{

specialty cedificates, the voluntary levels of standards, as well as the two g partnerships will use the same criteria types of certificates. liowever, as noted 415-6377, inteme hMmngov.

that the NSSB will use to review the earlier, the voluntary partnerships--not SUPPLEMENTARY INFORMATION: 4 work of the voluntary partnerships the NSSB-would review the specialty themselves (these criteria are described certificates for adherence to the NSSB's j $'u r f Public Comments and NRC s below). The voluntary partnerships also pohcies.

Respemse will ensure that the standards for Some of these criteria are required by 10. Summary of Agreement state Comments l

prospective specialty certificates build the National Skill Standards Act, and NRCs Response

, directly on the standards for the basic including consistency with civil rights IV. The Commission Policy artificate(s). Specialty certificates could law; meeting or exceeding the highest i*Back 8"""d cover overlapping--or even identical- applicable U.S. standards; and 4 jobs or functions. Ily allowing procedures to periodically revise and Section 208 of the Energy .

competition among those who develop up,date the system. Reorganization Act of 1974 (Pub. L. 93-standards at the detailed specialty level, M. 2 E. SM, as amenM Signed at Washington, DC this 13th day of ,

the skill standards system can adapt to December,1996. required the Commission to submit to j ,

changes in technology, work Edie west, Congress each quarter a report listing for organization, and customer preferences. ExecutiveDirwtor Nationalskinstandard" "

it faci i y which is e e or

The Board will require each voluntary Board' otherwise regulated pursuant to the partnership to develop a plan to meet IFR Doc. 96-32224 Filed 12-18-96; a 4'5 aml Atomic Energy Act of 1954, as amended, the needs of experienced workers. The anmo coos 4sm 7 plan will include in its skill standards or pursuant to this Act. In a letter to the Senate Subcommittee on Oversight of -

system an opportunity to acquire and Government Management, dated demonstrate through assessment the NUCLEAR REGULATORY October 1,1993, the NRC recommended ,

skill and knowledge required for the COMMISSION to Congress a change in the AO report p basic certificate.

' publication frequency from quarterly to ~

~ Voluntary partnerships may begin the Abnormal Occurrence Reports: yearly. As a result, Senate 790," Reports sing implementation of Section 208 Energy Elimination Act," Public Law 104-66,

• analytical standards at process of develofevel(s),

the broad core or Reorganization Act of 1974; Final was signed by President Clinton on i by reviewing the narrower specialties if Policy Statement December 21,1995, changing the AO

, these already exist in the sector. AGENCY: Nuclear Regulatory report to a yearly publication.

liowever, the NSSB will only endorse Commission. For the purposes of Section 208 of the the work of voluntary partnerships that Acim Final policy statement. Energy Reorganization Act of 1974, as submit basic certificates to the Board amended, an AO is an unscheduled before the voluntary partnership

SUMMARY

This final policy statement incident or event which the endorses specialty certificates. . presents the revised criteria the Commission has determined to be b

4 hg .

.i

Federal Register / Vol. 61, No. 245 / Thursday, December 19, 1996 / Notices 67073 significant from the standpoint of public Imlicy on a number of ocx:asions to The policy statement contains criteria health and safety. Each such report shall reflect changes in regulation and policy. that include the reporting thresholds for I contain: On the basis of these criteria, and as determining those incidents and events i (t)The'date and place of each occurrence: required by Section 208 of the Energy that are reportable by NRC for the (2) The nature and probable consequence Reorganization Act of1974,as purposes of Section 208 of the Energy of each occurrence: amended, the Commission has issued Reorganization Act of 1974, as (3J The cause or causes of each; and - quarterly reports to Congress on AOs amended. The Commission has (4) Any action taken to prevent recurrence. since March 1977. These reports, established the reporting thresholds at a l The Commission also shall provide as " Report to Congress on Abnormal level that will ensure that all events that wide dissemination to the public of the Occurrences," fiave been issued in should be considered for reporting to infortnation specified in clausps (1) and NURE40090-6 through to and Congresc 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 i within 15 days of its receiving Based on its experience in the the normal level of reporting to NRC to l information of each AO and shall preparation and issuance of AO reports, exclude those events that involve some i!

'I 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 j; information specified in clauses (3) and Energy Reorganization Act of 1974, as public health and safety. jj (4) as soon as such information becomes amended, can be carried out more  !

available. appropriately if the existing AO criteria Lycensee Reports In July 1975,in the exercise of the are revised to reflect changos in the This final general statement of policy 8 i; authority conferred upon the Commission's policy and changes to the will not change the reporting Commission by Congress to determine regulations, ruquirements imposed on NRC licensees which unscheduled incidents or events The NRC staff proposed to the by Commission regulations, license cre significant from the standpoint of Commission the final revision of the AO conditions, or technical specifications pubile health and safety and are criteria in 1995. The Commission (TS). NRC licensees will continue to I reportable to Congress as AOs, the approved publication in the Federal submit required reports on a wide l Commission developed interim criteria Register of the AO criteria (January 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 legan issuing quarterly reports to this final general statement of policy Commission in monitoring operating Congress on AOs. These reports,' that describes the manner in which the trends oflicensed facilities and in Commission will,as part'of the routine the actual performance of

" Report to Con ress on Abnormal comparinfities with the potential Occurrences," ave been issued in conduct of its business, carry out its these faci l NUREG 75/090 and NUREG-0090-1 msponsibilities under Section 208 of the performance for which the facilities l Energy Reorganization Act of 1974, as were designed and/or licensed. l through 5 for the period from January Information pertaining to all events 1975 through September 1976. On the amended, foridentifying AOs and j basis of its experience in the reparation making the mquisite information reported to the NRC will continue to be l concerning each occurrence available to made available and placed in the pubhc l end issuance of AO reports, t e document rooms for pubhc perusal. In Commission issued a general statement Congress and the public in a timely manner. Included in this policy addition, the NRC publishes annual of policy that described the manner in reports on events (NUREG-1272 series).

statement are criteria that the ,

which it would, as part of the routine Information can also be obtained by Commission will use in determining conduct ofits business, carry out its writmg to the U.S. Nuclear Regulatory responsibilities under Section 208 of the whether a particular event is a Commission, Public Document Room, reportable AO within the meaning of Energy Reorganization Act of 1974, as 2120 L Street, NW. (Lower Level)

Secti n 208 of the Energy amended, for identifying AOs and Reorganir.ation Act of 1974, as Washington, DC 20555-0001,. In m: king the requisite information addition, the Commission will continue concerning each occurrence available to amended. It is expected that as additiomil experience is gained, changes to issue news announcements on events Congress and the public in a timely that seem to be newsworthy whether or in the critena may be required.

m:nner. This eneral statement of n t they are reported as AOs.

policy was pu lished in the Federal Abnormal Occurrence Reporting Register on February 24,1977 (42 FR The general statement of policy has II. Summary of Public Conunents and 10950) and provided criteria and been developed to comply with the the NkC's Response ex:mples of types of events that the 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 reportable amended, to keep Congress and the regulations and policy. liefore arriving to Congress as an AO. 'I he Commission ublic informed of unscheduled to the revised AO criteria, the NRC staff h:s since refined this statement of facidents or events which the evaluated several AO approaches and Commission considers significant from consulted with experts in tne reactor shnIe*n It otNu~e# '$."tYE c',o rn%f the standpoint of public health and and nuclear material areas, including ni Printing Ofhce, tr.O DOX 370a2). Washington. DC safety. The policy reflects a range of the Advisory Committee on the Medical zo4ez-932s copies are .1:a available from the health and safety concerns and is Uses ofIsotopes (ACMUI), and held National Tot hnical Information Serviu. 5285 Port applicable to incidents and events workshops with Agreement States to involving a single occupational workbr obtain their comments. This effort was s i bl rn ion an / yn r a fee lh the NRC Public Document Roo n. 2120 L Street. NW as well as those havmg an overall to ensure that only events that have the (Lower level), Washington, Dc. 20e37 impact on the general public, potential for significant health and

i 3

67074 Federal Register / ~Vol. 61 No. 245 / Thursday, December 19, 1996 / Notices 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, changing 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 04-275," Revised AbnormalOccurrence Elimination and Sunset Act," the NRC consistent with 10 CFR Part 20, using Criteria" that provided the Commission concludes that the AO report remains the revised AO dose threshold for other a draft of the revised AO criteria 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) the NRC does not have a five times the annual regulatory limits

. Reorganir.ation Act of 1974; Proposed fair mechanism for ascertaining public during the individual's lifetime. Based g

f Policy Statement" was published for a 90-day public comment period, that perception; and (c) events may be perceived as AOs and give the ,

on NRC's experience, unlike a PSE, an AO unintended exposure event is based p, 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 ACMUI on the Response: 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

• wide Congressional and public interest. the AO dose threshold to the lens of the

" 7ublished in the FRN. Examples are events that resulted in The NRC received five lettem of a comment on the revised AO policy petitions to the Commission by publ'c e[e,

, ouldthe bone marrow, be increased. To be and the gonads; consistent statement published in the FRN from interest groups, events that may have with the AO thmshold used for medical 2 the following orEanizations: Virginia resultod in power reductions or misadministrations, the threshold to the i Power; the Clean Water Fund of North shutdowns for safety-related reasons, . lens of the eye is raised to 1 Sv (100 I Carolina; the American College of and events involving widespread media rem)instead of the proposed 500 mSv  !

Nuclear Physicians, California Chapter; coverage. Some of these events have f (50 rem). The 1 Sv (100 rem) dose the Government Relations Office of the also resulted in significant regulatory threshold is still below the dose for  ;*

American College of Nuclear effort, such as an NRC incident known deterministic effects in the lens l

Physicians / Society of Nuclear Medicine; investigation Team response. Although of the eye such as cataracts. [NCRP f and the Nuclear Energy Institute. These these events are not required by law t Commentary No.7j I

comments may be examined at the U.S. be listed in AO reports, the Also, the dose threshold for the bone J

Nuclear Regulatory Commission, Public Commission, as a matter of marrow and gonads will be revised to 1 p;

l Document Room,2120 L Street, NW. discretionary policy, directed the NRC Sv (100 rem)instead of the 2500 mSv i I

(Lower Level) Washington, DC 20555- staff to include them to keep Congress (250 rem) recommended in the b l

0001. Each letter contained more than and the ublic fully informed. comment. The revised dose is still at the }

j The C has not developed specific

, one comment, and these comments are threshold for temporar bone marrovi i categorized into three groups: (1) modify criteria for the appendix of the AO , depression but below t e dose threshold I and/or discontinue the AO reporting report on "Other Events of fnterest.. for permanent sterility from a single  !

process; (2) revise the dose threshold for This allows discretion on the part of 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 rnarrow h.

I unintended exposums 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 ofInterest, listing will have a full from the rest of the organs (unlike 10 medical licensees. Public comments on description of the basis forinclusion of CFR Part 20), due to the deterministic the proposed policy statement and each event in the report and a clear effects to these organs at the revised AO NRC s response are presented below indication 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 I Reporting AO Events to Congress on dose equivalent (TEDE) for AO reporting NRC s response. y,,,,,,g,g g,po,u,,, ,o ,, , guy, ,,g go, ,, ,9 ,7,og,g , pug;;c ,youyg 9, A. Modify and/or Discontinue the AO a Minor or on Embrp/ Fetus reduced to less than 4.50 mSv (0.450  ;

Reporting Pmss mm)instead of the proposed TEDE of Comment: a. Because the revised .

unintended AO dose threshold values 250 mSv (25 rem). p Comment: Because people who receive the quarterly AO reports do not for the whole body and any individual Response: According to the National Council on Radiation Protection and y

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 little true value, are genern!!y consistent with the j

effective dose equivalent rate to a gi the NRC should request legislation to " Planned special exposures" (PSEs) of discontinue the AO reporting process. 10 CFR Part 20 (five times the annual Person in the United States from natural r radiation and man-made sources is j Response:The value of the AO report regulatory limits), for consistency the to Congress was recently examined in dose threshold for the lens of the eye appmximately 360 mrem per year.2 This i the legislation reducing the publication should be revised to 750 millislevert . dose value is about the same as the j frequency of the report from quarterly to (mSv)(75 rem),instead of the proposed c mmenter s suggested dose threshold annually as recommended by the NRC f r mp rting Aos involving members of AO threshold of 500 mSv (50 rem).

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

• Government Management. As a result, sum of deep-dose equivalent and the ,,th (foi1 kPRe$ItIoIs Nn"al I

Senate 790 Reports Elimm, ation and committed-dose equivalent to any council on Radiation Protection and Measurements. l Sunset Act," Public Law 104-66, was individual organ or tissue except the septemtw 1987.

?

Federal Register / Vol. 61 No. 245 / Thursday Deccmber 19, 1996 / Notices 67075 Congress each exposure of a member of C. Reevaluate the AO Criteria '

eliminate reporting events to Congress

the public due to NRC-licensed Applicable,to Medico / Ucensees that do not have any medical cctivities at the level of the average dose Comment

The oposed medical AO significance.

received annually from natural and criteria are worse fian the current Response:The NRC believes that the man.made sources of radiation in the criterin because they will continue to dose thresholds of the revised criteria United States is inappropriate. The NRC inappropriately designate non. have sufficient margin included to limit selected the revised AO dose on the significant events as AOs. the reporting ofinsignificant events. In basis of the potential for radiation addition, the NRC considers it Response:The revised medical AO

• ndverse health effects to an individual, criteria should result in fewer AOs than important to report events that have the independent of the individual's status have been reported previously to Potentiolto result in adverse public as a radiation worker in an occupational Congress. These revisions wem made in health and safety.The inclusion of the environment or as a member of the response to NRC staff rec nition of the recommended criterion would preclude public. This threshold is below the level previous low dose threshhds thatm; orting of these events. Therefore, the of dose for which the potential for resulted in reporting events that did not NRC does not intend to include the morbidity is considered significant for have significant radiation consequences. PmPosed language.

Individuals with an increased organ and In addition, the new criteria also Comment: Insignificant medical tissue sensitivity to radiation. respond to previous public criticism events have been included in the past Comi and to changes in other NRC regulations AO reports to Congress.

minor o,nent:The r embryo / fetus annualshouldTEDEbe to any relating to radiation protection. Response:The NRC understands the 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 mSv (5 rem). from the AO policy statement because policy before the revision. Because of the NRC does not have sufficient the low dose thresholds established in Response:The NRC understands the sensitivity of an unintended exposure to competence in medicine and pharmacy the previous criteria, medical events to determine public safety significance that have not had the potential to result a minor or an embryo / fetus and of medical events. In significant radiation consequences to recognir.es that the radiation health sffects are age dependent because Response: Decause the NRC regulates patients were determined to be AOs and byproduct materialincluding the were reported to Congress. As a result, organs and tissues in minors, fetuses, cnd embryos are more radiosensitive medical use of this material, criteria for the Commission is revising the AO medical events have been developed criteria dose thresholds for medical than a typical adult. Therefore, a dose evente m xclude insignificant events.

threshold of 50 mSv (5 rem) was and must be included in the AO policy established for any minor or embryo / statement to comply with Section 208 of III. Summary of Agreement State fetus, which is lower than the adult AO the Ene y Reorganization Act of 1974' Comments and NRC's Response threshold of 250 mSv (25 rem). as amen ed.The revised criteria are .

based on widely accepted standards for Seven Agreement States submitted 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 rem)is at or below the average dose that believes that events exceeding the SECY-94-275 , Revised Abnormal I c person (including minors)in the criteria are sufficiently important to Occurrence Criteria.* These States were

! United States receives annuall from inf rm Congress and the public. Arkansas, Georgia, Kentucky, New York, I n:tural radiation and man-ma e sources C mment:Congmss may obtain Texas, Tennessee, and Washington.

l as stated in the response to an earlier inf nnation on significant medical After evaluating the comments, several comment. The threshold established by events from the FDA instead of the NRC. were incorporated in the Comm,ssion i i NRC is below the minimum threshold Re8Ponse:Section 208 of the Energy paper. A summary of the Agreement

! doses for permanent detenninistic Reorganization Act of 1974, as State , comments applicable to the AO sffects in selective organs for a minor or amended, requires reporting to Congress cntena listed in the proposed policy rn embryo / fetus' licensee events that the NRC dete'rmines statement as published in the FRN, and Comment:The criteria related to a to be significant from the standpoint of NRC's response are presented below:

nursing child, fetus, or embryo as a result of an exposure to a nursing public health and safety. An enactment' yo ify, Rm uote and/or oflaw would be necessary to change Discontinue Items of the AO Reporting mother or pregnant woman should be this requirement and appoint another cess deleted arom the criteria until the agency such as the FDA to undertake propose.d rule addressing these the AO responsibility. Comment: Four States commented on exposures is resolved through the Comment: ACMUI should review the the specific guidelines of a prior advice of the Advisory Committoe on medical AO criteria. revision of the proposed appendix of the Medical Daea ofIsotopes (ACMUI) and Response:The revised criteria were AO report on "Other Events of Interest" e separate pablic comment period. presented to ACMUI and comments or wanted "Other Events of Interest" Respons s:The NRC recognizes the received were incorporated before deleted, lack of a r pecific regulation to address publishing them in the Federal Register Response:It should be noted that the cxPosures as a result of an unintended (January 9,199% 61 FR 661). Only section on "Other Events of Interest" administration of radioactive material to minor changes have been made to the contained in this final AO policy a patient that is pregnant or nursing. criteria since ACMUI's review. statement has been revised since the Based on NRC's experience, some of Comment: Add a third condition to time that Agreement States provided these events have the potential for the medical AO criteria to read:"and (c) comments, and therefore comments on significant health and safety is a radiation exposure that has resulted the specific guidelines of the section do c:nsequences to 6 minor or an embryo / in unintended permanent functional not apply. In reference to the fetus and should be reported to damage to an organ or a physiological elimination of"Other Events of Congress, sys?em as determined by a physician" to Interest," see NRC's response to the

- . - - . = _ _ _ - _ __ - _ _ _ _ - _ _ _ _ _ _ _ _

i i'

67076 Federal Register / Vol. 61, No. 245 / Thursday, December 19, 1996 / Notices k .

4 second public comment under Category establish a single dose threshold value 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 reporting these events to the NRC.

wrong individual (wrong patient)? Response: See response to fourth

/

the AO criteria should apply to which are significant from a health and public comment under Category B.

exposures from non-Atomic Energy Act (AEA) material. safety standpoint. The basis was that, IV. The Commission Policy-General Response:Section 208 of the E,nergy for the purpose of reporting to Congress' Statement of Policy on implementation Reorganization Act of 1974, as the potential for physical harm to an of Section 208 of the Energy amended, provides that the Lommiss, ion individual resulting from the Reorganization Act of1974, as shall submit to Longress each yeal a unmtended exposure is the same A"*"ded report listing for that period any AOs at whether the exposure was received in q 1. A PPlicabihty. Implementation of or associated with any facility which is an occupational setting, as a patient Section 208 of the Energy licensed or otherwise regulated who was not intended to receive a Reorganization Act of 1974, as pursuant to the Atomic Energy Act of prescribed dose, or as a member of the amended AbnonnalOccurrence 1954, as amended, or pursuant to this public.

Comment:Three States suggested Reports, involves the conduct of Act.Therefore,the AO criteria will not Commission business and does not apply to events involving the use of providing credentials for a " physician" Impose requirements on licensees.

non AEA material since this material is as listed in criterion I.A.3. Reports will cover certain unscheduled not regulated by the NRC. Response:For general purposes the Comment:One State nommented that term " physician" is defined in 10 CFR incidents or events related to the Part 35.2, where " Physician means a manufacture, construction, or operation the AO policy statement imposes of a facility or conduct of an activity medical doctor or doctor of osteopathy additional requirements on licensees, subject to the requirements of Parts 20, Response:The AO policy statement licensed by a State or Territory of the United States, the District of Columbia, 30 through 36,39,40,50,61,70,71,or will not change the reporting requirements imposed on NRC licensees or the Commonwealth of Puerto Rico to 72 of Chapter 1, Title 10 Code of Federal prescribe drugs in the practice of Regulations (to CFR).

by Commission regulations, license Through an exchange of information.

medicine."

conditions, or tecimical specifications.

Although the NRC regulations do not Agreement States provide information The NRC licensees will ccntinue to to the NRC on lucidents and events submit required event reports. The AO specify the detailed credentials of a "P hysician" for incident evaluation involving applicable nuclear materials criteria will only be used by the NRC Purposes, the NRC staff has developed that have occurred in their States. Those during internal review and evaluation events reported by Agreement States an NRC Inspection Manual Chapter for reporting significant events to (IMC 1360) "Use of Physicians and that reach the threshold for reporting as Congress. an AO are also published in the " Report Comment: One State commented that Scientific Consultants in the Medical criterion I.A 3 is arbitrary, Consultant Program" that provides to Congress on Abnor.nal Occurrences."

Response:The NRC disagrees. guidance on the use of NRC consultants 2. Definition of terms. As used in this Because 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 I

l.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 ensure timely and comprehensive that is licensed or otherwise regulated, functional damage to an organ or a review of medical events. IMC 1360 and pursuant to the Atomic Energy Act of physiological system at thresholds below those listed in the AO criteria. Management Directive 8.10 are available 1954, as amended, or the Energy l

flowever, the NRC believes that there in the NRC public document soom,2120 Reorganization Act of 1974, as amended, that the Commission will be very few of these events. In most L Street, NW, (lower Level),

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. Be Consistent With the Regulations and doses above the proposed AO and Reconsider the Criterion for a (b) an _ unintended radiat.ion I

thresholds. Minor, or an Ernbryo/ Fetus exposure, includes any occupational Comment: One State commented that Comment: One State commented that exposure, exposure to the general criterion I.D.3 is arbitrary. public, or exposure as a result of a Response:The NRC disagrees. Based the AO criteria should be consistent  !

! medical misadministration (as defined on NRC's experience, certain reported with to CFR Part 20.

events, although they did not result in Response:To the extent practical, the in S 35.2) involving the wrong NRC has been consistent with 10 CFR individual that exceeds the reporting significant radiation consequences, had Part 20 and at the same time has values established in the regulations.

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 serious failure of the licensees's radiation protection program and lack of in deterministic effects due to for reporting as an AO under the criteria '

unintended exposures. for medical licensees. In addition, management control and oversight and Comment:Two States expressed unintended radiation exposures include should be reported to Congress. conarn about developing an AO dose Comment: Two States commented any exposure to a nursing child, fetus, threshold for events regarding a minor- or embryo as a result of an exposure that " wrong patient" should be considered in the misadministration AO or an embryo / fetus since the NRC has (other than an occupational exposure to criteria instead of the general AO an undeclared pregnant woman) to a criteria applicable to all licensnes. 5 in the Federal Register notice dated September nursing mother or nregnant woman Response:In the SRM of May 19 "WdNN* E b Parts 20_ and 3s, eK bd da 1994, on SECY-93-259, the NRC staff Radioactive Maiertal," the term wrong patient" 3. Abnortnal occurrence general was directed by the Commission to ... replaced by the terrn " Wrong individual." statement of policy. The Commission L __ _________ - ___-______ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

b Federal Register / Vol. 61, No. 245 / Thursday, December 19, 1996 / Notices 67077 will be considered for reporting as AOs greater than the regulatory limits in to f 11 ap ly the following oficy in determfrd g whether an fncident or are as follows: - CFR 71.51(a)(2).

I, For AllLicensees C. Theft, Diversion, or Loss of, Licensed cti ity that is licensed or erwise Material, or Sabotage or Secunty regulated by the Commission is an AO A. Iluman Exposure to Radiation From Breach

• within the purview of Section 208 of the Licensed Material

• 1. Any lost, stolen, or abandoned En:rgy Reorganization Act of 1974, as 1. Any unintended radiation exposure sources that exceed 0.01 times the Ai amended. to an adult (any individual 18 years of values, as listed in 10 CFR Part 71, An incident or event will be age or older) resulting in an annual total appendix A, Table A-1, for speciel form considered an AO f fit involves a major effective dose equivalent (TEDE) of 250 (3,aled/nondispersible) sources, or the reduction in the degree of protection of millislevert (mSv) (25 rem) or more; or smallrr of the A2 or 0.01 times the As 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 /disporsible) moderate or more severe impact on the committed 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 be lim!ted to the organ or tissue other than the lens of the reporting under this criterion are those following: eye, bone marrow and the gonads,of events involving sources that are lost, i11 Moderate exposure to. or release of, 2500 mSv (250 rem) or more; or an stolen, or abandoned under the r:dloactive maternal licensed by or otherwise annual dose equivalent to the lens of the following conditions: sources regulated by the Commission; eye, of 1 Sv (100 rem) or more; or an (2) Major degradation of essential safety. abandoned in accordance with the rekted equipment; or annual sum of the deep dose equivalent requirements of 10 CFR 39.77(c); sealed (3) Major deficiencies in design, and committed dose equivalent to the sources contained in labeled, rugged omstruction, use of, or management controls bone marrow, and the gonads, of 1 Sv source housings; recovered sources with for licensed facilities or material. (100 rem) or more; or an annual sufficient indication that doses in excess Criteria by type of event used to shallow-dose equivalent to the skin or of the reporting thresholds specified in extremi;ies of 2500 mSv (250 rem) or A0 criteria I.A.1 and I.A.2 did not occur determine which incidents or events will be considered for reporting as AOs more. during the time the source was missing; are set out in appendix A of this policy 2. Any unintended radiation exposure and unrecoverable sources lost under l

striement- to any minor (an individual less than 18 such conditions that doses in excess of

4. Commission disseminotw, n of years of age) resulting in an annual the reporting thresholds specified in A0 potential AO and AO information. TEDE of 50 mSv (5 rem) or more, or to criteria I.A.1 and I.A.2 were not known (a)The Commission will provide as an embryo / fetus resulting in a dose ~ to have occurred.

wide a dissemination of information to equivalent of 50 mSv (5 rem) or more.

2. A substantiated case of actual or thi public as reasonably possible. 3.An radiation exposure that has attempted theft or diversion of licensed Information on olential AOs (events resulte in unintended permanent material or sabotage of a facility.

th:1 may meet t te AO criteria) will be functional damage to an organ or a 3. Any substantiated loss of special

, sent to the NRC Public Document Room physiological system as determined by a nuclear material or any substantiated and all local ublic document rooms as physician. inventory discrepa.ncy that is judged to soon as possi le after the staff be significant relative to normally determines that the incident is a B. Discharge or Dispersal of Radioactive ec om e, d potential AO. A Federal Register notice Material From its Intended Place of , g , eit o diversion will be issued on each AO report with Confinement or by substantial breafdown of the copies distributed to the NRC Public L The release of radioactive material accountability system.

Document Room and all local publi 4. Any substantial breakdown of to an unrestricted area in concentrations document rooms. When additional which,if averaged over a period of 24 hysical security or material control hours, exceed 5000 times the values fi.e., access control containment or 11 ate at the n o tion n specified in Table 2 of appendix B to 10 accountability systems) that obtained at the NRC Public Document CFR Part 20, unless the hcensee has sigmficantl weakened the protect,on i Room and in oillocal public document dem nstrated compliance with against the t, diversion, or sabotage.

rooms, 5 20.1301 using S 20.1302 (b) (1) or D. Other Events (i.e., Those concerning (b) Each year, the Commission will 20.1302 (b) (2) (ii). . Design, Analysis, Construction, Testing, submit a report to Congress listing for that period any AOs at or associated 2. Radiation levels in excess of the Operation, Use, or Disposal of Licensed with any facility or activity which is design values for a package, or the loss Facilities or Regulated Materials) licensed or otherwise regulated of confinement of radioactive material 1. An accidental criticality 110 CFR pursuant to the Atomic Energy Act of resulting in one or more of the 70.52(a)).

1954, as amended, or the Energy following:(a) A radiation dose rate of10 2. A major deficiencym, design, mSv (1 rem) per hour or more at 1 meter construction, control, or operation Reorganization Act of1974,as amended. This report will contain the (3.28 feet) from the accessible external surface of a package containing dite, place, nature, and probable radioactive material;(b) a radiation dose ainformation pertainin to certain incidents rnay consequence of each AD, the cause or c:uses of each AO, and any action taken rate of 50 mSv (5 rem) por hour or more $,'j'y.*ciannined information will bej" on the accessible external surface of a implications to prevent recurrence.

package containing radioactive material wHhheld when formally reporting these incidents in accordance with section zoa or,the Enersy Appendix A-AbnormalOccurrence and that meet the requirements for Criteria h *"i2*"

3 " ^*' ' 84 ** ***"d'd" ^" Y . t

" exclusive use" as defined in to CFR '

Criteria by types of events used to 71.47; or (c) release of radioactive N'laYbletItN5h.uNr est$ndiI material from a package in amounts appropriate curity arrangements.

determine which incidents or events

n

~~

l', ,.

i

\

87078 Federal Register / Vol. 61, No. 245 / Thursday, December 19, 1996 / Notices (a) Results in a dose that is (1) equal having significant safety implications requiring immediate remedial action, to or greater than 1 gray (Gy) (100 rads) y to a major portion of the bone marrow,

3. A serious deficiency in to the lens of the eye, or to the gonads, management or procedural controls in major areas.

or (2) equal to or greater than 10 Cy r,

(1000 rada) to any other organ: and i 4. Series of events (where individual

• events are not of major importance). (b) Represents either (1) a dose or recurring incidents, and incidents with dosa8e that is at least 50 percent greater s

implications for similar facilities than that prescribed in a written I directive or (2) a prescribed dose or

') y (generic incidents) that create a major safety concern.

dosage that (1)is the wrong r8di P harmaceutical,5 or(ii)is delivered

! II. For Commercial Nuclear Power Plant by the wrong route of administration, or

! Dans ees (111)is delivered to the wrong treatment A. Malfunction of Facility, Structures, site, or (iv) is delivered by the wrong treatment mode, or (v) is from a leaking or Equipment source (s).

1. Exceeding a safety limit of license technical specification (TS) ($ 50.36(cll. V. Culdelines for "Other Events of

2. Serious degradation of fuel Interest" integrity, primary coolant pressure The Commission may determine that boundary, or primary containment events other than AOs may be ofinterest boundary. to Congress and the public and be

3. Loss of plant capability to perfonn included in an appendix to the AO essential safet,y functions so that a report as Other Events of Interest."

release of radioactive materials, which Guidelines for events to bo included in could result in exceeding the dose limits the AO report for this purpose are items l of to CFR Part 100 or 5 times the dose limits of 10 CFR Part 50, appendix A, that publicmay to ofbossibly be perceived by the health or safet l

General Design Criterion (GDC) 19, significance. Such items wou d not  ;

could occur from a postulated transient involve a major reduction in the level of j or accident (e.g., loss of emergenc core protection provided for public health or .

cooling system, loss of control ro safety; therefore, the would not tw l system). reported as abnorma occurrences. An B. Design or Safety Analysis Deficiency, example is an event where upon final PersonnelError, or Procedural or evaluation by an NRC Incident Administrative Inadequacy Investigation Team, or an Agreement State equivalent response, a

1. Discovery of a major condition not determination is made that the event specifically considered in the safety does not meet the criterla for an analysis report (SAR) or TS that requires abnormal occurrence.

i ed dlal d' '

2 Pe nne error o edural og$'emte deficiencies that result in loss of plant For the Nuclear Regulatory Commission.

capability to perform essential safety Jo Hoyle, functions so that a release of radioactive 8'C"'"'T / d C **I88' "-

materials, which could result in exceeding the dose limits of to CFR Part IFR Doc. W32210 Filed 12-18-96: 8:45 aml

' P'Luseo caos ressai-e l

100 or 5 times the dose limits of to CFR

Part 50. appendix A.GDC 19,could occur from a postulated transient or J' accident (e.g., loss of emergency core cooling system, loss of control rod I system). I fil. For Fue'l Cicle Ucensees

1. A ret, .ed plant shutdown as a result of violating a license condition or other safety limit.

2. A major condition not specifically considered in the license that requires immediate remedial action.

3. An event that seriously compromises the ability of a #

confinement system to perfonn its 'N =fa radiophannaceutical as un'ed in the designated function. AO criteron for medical misadrninistrations refers to any radiopharmaceutical other than the one IV. For Medical Ucensees listed in the mitten directive or in the clinical prucedures manuat A medical mit) administration that:

ALL AGREEMENT STATES $6N 171997 )

MASSACHUSETTS, OHIO, OKLAHOMA, PENNSYLVANIA j

!- TRANSMITTAL OF STATE AGREEMENTS PROGRAM INFORMATION

(SP 003) l r

l- Your attention is invited to the attached correspondence which contains:

i INCIDENT AND EVENT INFORMATION............ XX REVISED ABNORMAL OCCURRENCE CRITERIA l- PROGRAM MANAGEMENT INFORMATION....... j

. TRAINING COURSE INFORMATION.................

i l I TECHNICAL INFORMATION........................... '

l OTHER I NFO R MATI O N . . ...... . ... . . .. . . . . . . . . . . .. . . .. . . l l

This letter is to inform you that the final policy statement covering abnormal occurrence ,

i (AO) reports has been published in the Federal Reaister. Vol. 61, No. 245, December 19, l t 1996 (copy enclosed), and is effective as of December 19,1996. l

) l 1 '

l Also enclosed is a copy of the November 7,1996, Commission Staff Requirements j Memorandum (SRM) response to the Staff Requirements-SECY 96193, Abnormal j j Occurrence Reports: Implementation of Section 208 Energy Reorganization Act of 1974, j Final Policy Statement. The SRM contains direction to staff to " file incident information on potential AOs in the Public Document Room's (PDRs) as soon as possible after the staff

! determines that the incident is a notential AO because it may meet the AO criteria."

If you have any questions regarding this correspondence, please contact me or the individual named below.

i- POINT OF CONTACT: Patricia M. Larkins

TELEPHONE

(301) 415 2309 .

. FAX: (301) 415-3502 Ot!nal sigm n,.

RfCHED L BANGW

! Richard L. Bangart, Director

! Office of State Programs

Enclosures:

As stated Distnbution D4R MF - (Assigned 11/12/96) DCD (SP03)

RLBcngart PDR (YES_X_ NO_,)

PLohaus SDroggitis RSOAs i E-Mailed PLarkins RSLOS ) 1/17/97 p

, HKaragiannis, AEOD f r g ', j pN' @'O AD.98e#

DOCUMENT NAME:

As. me.@ in m. m.a:G*\pmi\ / P97003.PL

v. h. . n e en e c A :(4 wuout .ei. chm.nu. ace.w. je con we ett. chm.nu.new.w. m - No e.n OFFICE m QSPl@, Og $ OSP:D[/ q l NAME PMikfkins:ndb PlWL6fiaus RLBan{l5rtl" DATE 01/15/97 01/))97 01/)QG7 OSP FILE CODE: SP A-4; SP;A-1 &g4f 4f/ - .

pgYmigRNRCOPY r A

"# 2PP .. _ _ _ _ _ __ __l

I UNITED STATES

. y+)Z2l[tjg g NUCLEAR HEGULATORY COMMISSION WASHINGTON. D.C. "a8 "1 o )

% y,,, # January 17, 1997 ALL AGREEMENT STATES MASSACHUSETTS. OHIO, OKLAHOMA, PENNSYLVANIA TRANSMITTAL OF STATE AGREEMENTS PROGRAM INFORMATION (SP-97 003)

Your attention is invited to the attached correspondence which contains:

INCIDENT AND EVENT INFORMATION............. XX REVISED ABNORMAL OCCURRENCE CRITERIA PROGRAM MANAGEMENT INFORMATION........

TRAINING COURSE INFORMATION..................

TECH NI CAL IN FO R M ATI O N. .... . . ....... ... . ...... .....

OTH E R I N FO R MATI O N. . .. .. . . . . . . .. . . .. . . . . . . . . . . . . . . .. . .

This letter is to inform you that the final policy statement covering abnormal occurrence (AO) reports has been published in the Federal Reaister, Vol. 61, No. 245, December 19, 1996 (copy enclosed), and is effective as of December 19,1996.

Also enclosed is a copy of the November 7,1996, Commission Staff Requirements Memorandum (SRM) response to the Staff Requirements-SECY 96193, Abnormal Occurrence Reports: Implementation of Section 208 Energy Reorganization Act of 1974, Final Policy Statement. The SRM contains direction to staff to " file incident information on

, potential AOs in the Public Document Room's (PDRs) as soon as possible after the staff j determines that the incident is a notential AO because it may meet the AO criter.E,."

i If you have any questions regarding this correspondence, please contact me or the individual named below. l POINT OF CONTACT: Patricia M. Larkins TELEPHONE: (301) 415 2309 FAX: (301) 415-3502 (I J t Ric lard C. Bangar ,hirector j V1 fit Office of State Programs ,/f

Enclosures:

As stated

UNITED STATES

1. g

,* f , NUCLEAR REGULATORY COMMISSION g ] WAGON, D.C. 20$55-0001

.... 96 NOV QfM '),4 1996 CFFICE OF THE SECMETARY MEMORANDUM TO: James M. Taylor Exec ve Di ctor for Operations FROM: John . Hoylv, cretary

SUBJECT:

STAFF REQUIREMENTS - SECY-96-193 - ABNORMAL OCCURRENCE REPORTS: IMPLEMENTATION OF SECTION 208 ENERGY REORGANIZATION ACT OF 1974; FINAL POLICY The Commission has approved publication of the final Policy statement on " Abnormal Occurrence Reports: Implementation of Section 208 Energy Reorganization Act of 1974; Final Policy Statement" subject to the changes noted in the attachment. Also, throughout the policy statement, all uses of the term " nursing infant" should be replaced with " nursing child."

-(4iOGt (AEOD) (SECY Suspense: 12/13/96) 9100142 The staff should file incident information on potential abnormal occurences (AOs) in the Public Document Rooms (PDRs) as soon as possible after the staff determines that the incident is a notential AO because it M c meet the AO criteria. The staff should not wait until an AO determination is made by the Commission, once a year, to make the incident information available to the public through the PDRs. In following this direction, the staff should place already-existing documents on these incidents in the PDRs and identify the incident as a potential AO. Preliminary Notifications, press releases, or morning report information filed in the PDRs will satisfy this directive. The staff should not develop lengthy, new documents for the PDRs on eac' incident to satisfy this Commission direction. Insteac6 che intent is to make information on major incidents immediately available to the public and categorized as potential AOs in advance of a final Commission decision, with minimal resource impact on the staff.

SECY NOTE: THIS SRM, SECY-96-193, AND THE VOTE SHEETS OF ALL COMMISSIONERS WILL BE MADE PUBLICLY AVAILABLE 5 WORKING DAYS FROM THE DATE OF THIS SRM.

4 The staff should begin to develop conforming changes to the final l AO policy statement to cover fuel cycle facilities that may  :

receive NRC certification. Specifically, the staff should j determine whether modifications to criteria III., "For Fuel Cycle l Licensees," are necessary to explicitly include fuel cycle facilities that are not licensed but are otherwise regulated such as the gaseous diffusion plants (GDPs). These conforming changes should be in place if and when NRC accepts jurisdiction for the GDPs.

4EDG) (AE0D/NMSS) (SECY Suspense: 3/3/97) 9600172 i

Following issuance of the FY 1997 AO report to Congress (in early 1998), the staff should report to the Commission on how NRC will identify unintended medical radiation exposures to an embryo / fetus or a nursing child and describe the staff's experience with voluntary reporting. In the staff's report, the staff should address whether the final AO policy criteria should be revised to omit reference to these types of incidents, if the staff does not recommend a mechanism to identify unintended medical radiation exposures to an embryo / fetus or a nursing t child.

-(GDG) (RES/AE0D/NMSS) (SECY Suspense: 3/13/98) 9600173

Attachment:

As stated cc: Chairman Jackson Commissioner Rogers Commissioner Dicus Commissioner Dia:

Commissioner McGaffigan OGC i OCA OIG Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)

5 15 i

Response: The revised criteria were presented to ACMUI and coments received I were incorporated before publishing them in the Federal Register (January 9, 1996: 61 FR 661). Sec u:0 00nly minor changes have been made to the criteria since ACMUI's revief, the C0-10:100 doc not belicyc th:t it is necc ::ry for ?C"UI to further c=ine the critcMa-Coment: Add a third condition to the medical A0 criteria to read: "and (c) is a radiation exposure that has resulted in unintended permanent functional damage to an organ or a physiological system as determined by a physician" to eliminate reporting events to Congress that do not have any medical significance. ,

l Response: The NRC believes that the dose thresholds of the revised criteria have sufficient margin included to limit the reporting of insignificant  !

events. In addition, the NRC considers it important to report events that have the ootential to result in adverse public health and safety. The inclusion of the recommended triterion would preclude reporting of these events. Therefore, the NRC does not intend to include the proposed language.  !

Coment: Insignificant medical events have been included in the past A0 reports to Congress.

Response: The NRC understands the commenters' concerns with the implementation of the medical A0 policy before the revision. Because of the low dose thresholds established in the previous criteria, medical events that have not had the potential to result in signific;nt radiation consequences to i

e

4 19 setting, as a patient who was not intended to receive a prescribed dose, or as a member of the public. .

i '

1 I

Conment: Three States suggested providing credentials for a " physician" as .

i listed in criterion I.A.3.  ;

i Response: For general purposes the term " physician" is defined in 10 CFR Part l 35.2, where " Physician means a medical doctor or doctor of osteopathy licensed

-by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine."

Although the NRC regulations do not specify the detailed credentials of  ;

a " physician" for incident evaluation purposes, the NRC staff has developed an NRC Inspection Manual Chapter (IMC 1360) "Use of Physicians and Scientific Consultants in the Medical Consultant Program" that ltt: a grcup cf phy icir; th:t the NRC St:ff my cbtain = pfdidss[ghidanbEMthelpsl5Mf l P_IRC consultants in case of an incident. M_sdd_it_id._iU_NR,C_:'stia_ff? hh51d.e_ Vel o. ped

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ensu[eitimelDMidsprfheis19QefieRopedidireiuntg The NRC :t:ff hn rev1=d the credentub cf th=0 phy;ti=: =d hr determi=d th:t they have the crpertte in :pecul1=d arcr =tg byprod=t =tcrtl for the Ovaluaticn Of radutien con:cquc cc . The Inspect 10- M=ual 21K1MaMMhii;jEiiiisnt  ;

DifectiVel8;]Ojare available in the NRC public document room 2120 L Street, l l

NW. (Lower Level), Washington, DC 20555-0001. i l

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unintended radiation exposures include any exposure to a nursing ef=t @]d, j fetus, or embryo as a result of an exposure (other than an occupational exposure to an undeclared pregnant woman) to a nursing mother or pregnant woman iti69$specjfiedjya]DM.

i

• 3. Abnormal occurrence ceneral statement of oolicy. The Commission  !

will apply the following policy in determining whether an incident or event at l

a facility or involving an activity that is licensed or otherwise regulated by the Comission is an A0 within the purview of Section 208 of the Energy Reorganization Act of 1974, as amended.

1 1

1 An incident or event will be considered an A0 if it involves a major j reduction in the degree of protection of the public health or safety. This 1 type of incident or event would have a moderate or more severe impact on the ,

i public health or safety and could include, but need not be limited to the  !

following:

(1) Moderate exposure to, or release of, radioactive material licensed ,

by or otherwise regulated by the Commission: .

l (2) Major degradation of essential safety-related equipment: or (3) Major deficiencies in design, construction, use of, or management '

controls for licensed facilities or material.

Criteria by type of event used to determine which incidents or events

will be considered for reporting as A0s are set out in appendix A of this policy statement.

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a 67072 Federal Register / Vol. 61, No. 245 / Thursday, December 19,1996 / Netes Certificates Offered Criteriafor the Skill Standards Commission wilI use in submitting the Although there is the potential for in order to qualif for Board annual abnorrnal occurrence (AO) three levels of knowledge and skills' endorsement, the sfill standards system reports to Congress and the public there will be only two types of recommended by the voluntary timely manner as stated in Section 208 Partnershi s (or the outside groups in of the Energy Reorganization Act of artificates: a basic certificate will encompess either the core alone (if there t o es alt " 1974 as amended. The AO policy

. {9 9w te n add n statebient has been revised to provide are no concentrations) or the core plus

' fs " h* m re specific criteria for determining one conantration level, and a specialty N i nb I St d .

those incidents and events that the cenificate will cover the specialty level Commission considers significant from of knowledge and skills. A volu:.tary e Follow a common nomer5clature pannership could establish basic identified by the Board'. the standpoint of public health and e Descrioe in clear terms the critical safety for reporting to Congress, and to artificates for up to six concentrations. make the AO policy consistent with work functions specific to the core, i

'Ihe voluntary partnership will concentrations, and specialties; recent changes to NRC regulations. The establish the standards for the basic e Describe the academic, revised AO criteria contain more artificate(s), which will then be employability, and occupational discrete reporting thresholds making ,

endorsed by the NSSD ifit meets the knowledge and skills necessary to them easier to use and ensuring more s 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 pohcy set forth by the j

accredited educationalinstitutions and e Adhere to statutory requirements Commission, training providers, and recognized and Board policy on assessment: EFFECTWE DATE: December 19,1996 third-party assessment groups) will e Bo consistent with civil rights law: ADORESSES: The proposed policy recommend the standards for specialty e Meet or exceed the highest 1l statement published in the Federal g certificates. These groups will present

' applicable standards used in the United Register (January 9,1996: 61 FR 661), --

standards for prospective specialty States, including registered and the comments received may be certificates to the voluntary partnerships 8Pprenticeship standards; examined at the NRC Public Document {~

for review and endorsement,in the e De benchmarked to the best Room,2120 L Street, NW. (Lower international standards: s same manner that the volunta

• Level), Washington, DC. .

partnerships will present stan ards for cj fp ,g T," updating and FOR FURTHER INFORMATION CONTACT: i basic certificates to the NSSB for review Ifarriet Karagiannis, Office for Analysis and endorsement. continuous improvement of standards '

l and certificates. and Evaluation of Operational Data. U.S.

la their review of prospective

{

specialty certificates, the voluntary These criteria will pertain to all three Nuclear Regulatory Commission, levels of standards, as well as the two Washington, DC 20555, telephone: (301)

,{ ,

9 partnerships will use the same criteria 415-6377, internet: hxk@nrc. gov.

l types of certificates. However, as noted b that the NSSB will use to review the earlier, the voluntary partnerships-not SUPPLEV"!NTARY INFORMATION:

work of the voluntary partnerships the NSSB-would review the specialty 4 themselves (these criteria are described 1 Back d i certificates for adherence to the NSSB's li. SurNary of Public Comments and NRC's '

below). The voluntary partnerships also policies. *

Response

will ensure that the standards for Some of these criteria are required by III. Summary of Agreement state comments 4 prospective specialty certificates build the National Skill Standards Act, and NRC's Response l directly on the standards for the basic including consistency with civil rights IV. The Commission Policy mrtificate(s). Specialty certificates could law; meeting or exceeding the highest cover overlapping-or even identical- applicable U.S. standards; and I.BacN,round "  !

jobs or functions. By allowing 4 i procedures to periodically revise and Section 208 of the Energy ,

competition among those who develop up,date the system. Reorganization Act of 1974 (Pub. L. 93- .

standards at the detailed specialty level, Signed at weshington, DC this 13th day of 438,42 U.S.C. 5848), as amended, -

the skill standards system can adapt to December,1996. required the Commission to submit to changes in technology, work Edie West Congress each quarter a report listing for -

organization, and customer gireferences. that period any AOs at or associated Executive Director, National Skill Standards The Board will require each voluntary Board. with any facility which is licensed or l partnership to develop a plan to meet (FR Doc. 96-32,224 Filed 12-18-96; 8i5 aml therwise regulated pursuant to the the needs of experienced workers. The su.seo coos ass" l plan will include in its skill standards frp uan o tiis A t a" ette o Ie system an opportunity to acquire and Senate Subcommittee on Oversight of a y demonstrate through assessment the NUCLEAR REGULATORY Government Management, dated a il and dge required for the COMMISSION October 1,1993, the NRC recommended -

to Congress a change in the AO report i Voluntary partnerships may begin the Abnormal Occurrence Reports: Pu ca n ncy analytical process of developing implementation of Section 208 Energy g, , 9n te 7ho, Reports standards at the broad core level (s), or %rganization Act of 1974; Final Elimination Act," Public Law 104-66,

', by reviewing the narrower specialties if Policy Statement was signed by President Clinton on I these already exist in the sector. December 21,1995, changing the AO

' AGENCY: Nuclear Regulatory report to a yearly publication.

Ifowever, the USSB will only endorse Commission. For the purposes of Section 208 of the the work of voluntary partnerships that ACTION: Final policy statement. Energy ReorEanization Act of 1974, as submit basic certifimtes to the Board amended, an AO is an unscheduled before the voluntary partnership

SUMMARY

This final policy statement endorses specialty certificates. incident or event which the presents the revised criteria the Commission has determined to be W

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Federal Register / Vol. 61 No. 245 / Thursday, December 19, 1996 / Notices 67073 significant from the standpoint of pub!!c policy on a number of occc.slons to The policy statement contains criteria health and safety. Each such report shall reflect changes in regulation and policy. that include the reporting thresholds for 4 contain: On the basis of these criteria, and as determinin8 those incidents and events l (t) The'date and place of each occurrence; required by Section 208 of the Energy that are reportable by NRC for the j (2) The nature and probable consequence ReorEanir.ation Act of1974,as purposes of Section 208 of the Energy i of each occurrence; amended, the Commission has issued Reorganization Act of 1974, as j (31 The cause or causes of each; and quarterly reports to Congress on AOs amended. The Commission has j (4) Any action taken to prevent recurrence. since March 1977 These reports, established the reporting thresholds at a j The Commission also shall 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 clauws (1) and NUREG-0090-6 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 ofit+ receiving Based on its experience in the the normal level of reportin8 to NRC to information of eact' AO and shall Preparation and issuance of AO reports, exclude those events that involve some iI provide as wide dissemination to the the Commission has decided that its variance from regulatory limits, but are !l pub!!c as reasonably possible the responsibilities under Section 208 of the not significant from the standpoint of 'l Information specified in clauses (3) and Energy Reorganization Act of 1974, as public health and safety. , I (4) as soon as such information becomes amended, can be carried out more available' appmpriately if the existing AO criteria UCen8ee Reports In July 1975,in the exercise of the are revised to reflect changes in the This final general statement of policy 8 suthority conferred upon the Commission's policy and changes to the will not change the reporting Commission by Congress to determine regulations. Aquirements imposed on NRC licensees 4 which unscheduled incidents or events The NRC staff proposed to the by Commission regulations, license l are significant from the standpoint of Commission 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 j Commission developed interim criteria Register of the AO criteria (January 9, spectrum of events, including events I 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 began issuing quarterly reports to this final general statement of policy Commission in monitoring operating Congress on AOs. These reports,' that descrites the manner in which the trends oflicensed facilities and in

" Report to Congress on Abnormal Commission will,as part'of the routine comparing the actual performance of Occurrences," have been issued in c nduct ofits business, carry out its these facilities with the potential NUREG 75/090 and NUREG-0090-1 responsibilities under Section 208 of the performance for which the facilities through 5 for Qe period from January Energy Reorganization Act of 1974, as were designed and/or licensed.

1975 through September 1976. On the amended, foridentifying AOs and Information pertaining to all events tesis ofits experience in the preparation makin8 the requisite information reported to the NRC will continue to be and issuance of AO reports, the concerning each occurrence available to rrade available and placed in the public Commission issued a general statement Congress and the public in a timely document rooms for public perusal. In of policy that described the manner in manner, included in this policy addition, the NRC publishes annual J which it would, as part of the routine statement are criteria that the reports on events (NUREG-1272 series). j conduct ofits business, carry out its Commission will use in determining Information can also be obtained by responsibilities under Section 208 of the whether a particular event is a writing to the U.S. Nuclear Regulatory ,

Energy Reorganization Act of 1974, as reportable AO within the meaning of Commission, Public Document Room, amended, for identifying AOs and Section 208 of the Energy 2120 L Street, NW. (Lower level) m: Ling the requisite information Reorganir.ation Act of 1974, as Washington, DC 20555-000t. In concerning each occurrence available to ***".ded. It is expected that as addition, the Commission will continue Congress and the public in a timely additional experience is gained, changes to issue news announcements on events minner. This general statement of in the criteria may be required. that seem to be newsworthy whether or policy was published in the Federal Abnormal Occurrence Reporting n t they are reported as AOs.

Register on February 24,1977 (42 FR II. Summary of Public Comments and The general statement of policy has 10950)and rovided criteria and been developed to comply with the the NRC's Response examples o types of events that the legislative intent of Section 208 of the The NRC decided to revise the AO Commission would use in determininR EnerEy Reorganization Act of 1974, as criteria to reflect changes in NRC whether a particular event is reportable amended, to keep Congress and the regulations and policy. Before arriving Public informed of unscheduled to the revised AO criteria, the NRC staff ha in ref ed th s s ten nt f incidents or events which the evaluated several AO approaches and

, Commission considers significant from consulted with experts in the reactor super nInde$t o[o cu2nIU erNn'f' the standpoint of public health and and nuclear material areas, including rrenting office. fr.o nox 37on2L washington. nc safety. The policy reflects a range of the Advisory Committee on the Medical 20402-9328 Copma are also avellable from the health and safety concerns and is Uses ofIsotopes (ACMUI), and held a

NIrNfUtN2 I*17Ip$Pon applicable to incidents and events workshops with Agreement States to N1 involving a single occupational workbr avallable for inspection and/or copyins for a fee in obtain their comments. This effort was the NRC Public Docunwnt Room. 2120 L Street. NW as well as those having an overall to ensure that only events that have the (Lower teelt washingion, tx 20027 impact on the general public. potential for significant health and 1

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l' 87074 Federal Registst /'Vol. 61, No. 245 / Thursday, December 19, 1996 / Notices

? asfety 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, changing 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 j' consistent with to CFR Part 20, using ti 94-275," Revised Abnormal Occurrence Elimination and Sunset Act," the NRC 1,' Criteria" that provided the Commission concludes that the AO report remains the revised AO dose threshold for other a draft of the revised AO criteria 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;fb) the NRC does not have a five times the annual regulatory limits t Reorganization 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 f

, 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 imm Agreement States or ACMUI on the Response: 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 wide Congressional and public interest. the AO dose threshold to the lens of tha

'Jublished in the FRN. Examples are events that resulted in The NRC received five letters of comment on thv revised AO policy petitions to the Commission by public e[e,

, ouldthe bone marrow, be increased. and the gonads To be consistent statement published in the FRN frorn Interest groups, events that may have with the AO threshold used for medical the following organizations: Virginia resulted in power reductions or misadrninistrations, the threshold to tie Power; the Clean Water Fund of Nerth shutdowns for safety-related reasons, lens of the eye is raised to 1 Sv (100 Carolina; the American College of and events involving widespread media rem)instead of the proposed 500 mSv Nuclear Physicians, California Chapter; coverage. Some of these events have (50 rem). The 1 Sv (100 rem) dose the Government Relations Office of the also resulted in significant regulatory threshold is still below the dose for American College of Nuclear effort, such as an NRC Incident known detenninistic effects in the lens }

Physicias,s/ Society of Nuclear Medicine; investigation Team response. Although of the eye such as cataracts. [NCRP }

and the Nuclear Energy Institute. These these events are not required by law to Commenta No.7) comments may be examined at the U.S. be listed in AO reports, the Also, the dose threshold for the bone A Nuclear Regulatory Commission, Public Commission, as a matter of Document Room,2120 L Street, NW. discretionary policy, directed the NRC marrow and gonads will be revised to 1 l(

Sv (100 rem)instead of the 2500 mSv (Lower Level) Washington, DC 20555- staff to include them to keep Congress (250 rem) recommended in the 0001. Each letter contained more than and the pubilc fully informed. comment. The revised dose is still at the one comment, and these comments are The NRC has not developed specific threshold for tem orar bone marrow '

cat orized into three groups:(1) modify criteria for the appendix of the AO ,, I depression but be ow t e dose threshe,!d and or discontinue the AO reporting report on 'Other Events ofinterest.

process; (2) revise the dose threshold for This allows discretion on the part of the d for permanent sterility from a single h d I

reportin AO events to Congress on NRC in the selection of the events t co uen due to I ne marrow f uninten ed exposures to an adult and a ensure exclusion of unimportant events. depression. For AO p rposes, the bone minor or an embryo / fetus; and (3) To avoid c,onfusion, the Other Events reevaluate the AO critena applicable to ofinterest listing will have a full marrow and thegonads are separatedn medical licensees. Public comments on description of the basis for inclusion of t 0) due t det inist c l the roposed policy statement and each event in the report and a clear effects to these organs at the revised AO (

NR s response ara presented below indication that these events are not AO::. dose thresholds. I followed by a section on the summary Comment:The annual total effective

• t State comments and B. Revise the Dose Thresholdfor

^ 8' Reporting AO Events to Congress on dose equivalent (TEDE) for AO reporting 4 fRCs Po - Unintended Exposures to on Adult and for members of the public should be e A. Modify and/or Discontinue the AO a Minor or on Embryo /Fe us reduced to less than 4.50 mSv (0.450 Reporting Process rem)instead of the proposed TEDE of Comment: a. Because the resised 8 250 mSv (25 rem).

Comment: Because people who receive the quarterly AO reports do not unintended AO dose threshold values for the whole body and any individual Response: According to the National lI ,

even read them, and the few that do organ or tissue except the lens of the eye Council on Radiation Protection and Measurements, the estimated average fl i

believe the reports have little true value, are generally consistent with the effective dose equivalent rate to a the NRC should request let;islation to " Planned special exposures" (PSEs) of Person in the United States from natural  ; I discontinue the AO reporting process. 10 CFR Part 20 (five times the annual Respor:se:The value of the AO report mgulatory limits), for consistency the radiation and man-made sources is j l to Congress was recently examined in done threshold for the lens of the eye approximately 360 mrem per year.2 This j l the legislation reducing the publication should be revised to 750 millislevert .d se value is about the same as the pl frequency of the report from quarterly to (mSv)(75 rem),instead of the proposed commenter's suggested dose threshold annually as recommended by the NRC I r r* Porting AOs involving members of AO threshold of 500 mSv (50 rem).

in a letter of October 1,1993, to the b.10 CFR 20.1201(a)(1)(li) specifies the public to Congress. Reporting to Senate Subcommittee on Oversight of the annual occupational limit for the 8 loniring Radiation Exposure of the Population Government Management. As a result, sum of deep-dose equivalent and the Senate 790," Reports Elimination and committed-dose equivalent to any $,h*[N2,$,E,cI,F,$nU,M,*,7,"j,,

,c Sunset Act," Public Law 104-66, was individual organ or tissue except the s.ptember soa7.

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p 67075 Federal Register / Vel. 61, No. 245 / Thursday, Dec:mber 19, 1996 / Notic:s Congress each exposure of a member of C. Reevaluate the AO Criterio

• eliminate reporting events to Congress the public due to NRC licensed App #coble,to Afedicolueensees that do not have any medical ,

activities at the level of the average dose Comment:The P oposed medical AO significance.

received annually from natural and cdteda are worse tl en the current Response:The NRC believes that the man-made sources of radiation in the criteria because they will continue to dose thresholds of the revised criteria United States is inappropriate. The NRC inappropriately designate non. have sufficient margin included to limit selected the revised AO dose on the significant events as AOs. the reporting of insignificant events. In basis of the potential for radiation addition, the NRC considers it Response:The revised medical AO

• adverse health effects to an Individual, criteda should result in fewer AOs than important to report events ths.t have the independent of the individual's status tentiolto result in adverse public heve been reported reviously to as a radiation worker in an occupational Congress. These revfslons were made Ithinand safety.The inclusion of the environment or as a member of the nition of the recommended criterion would preclude public. This threshold is below the level response previous lowtodoseNRC staff re-)ds that thresh re orting of these events.Therefore, the of dose for which the potential for resulted in reporting events that did not NkC does not intend to include the morbidity is considered significant for have significant radiation consequences. PmPosed language.

,c tividuals with an increased organ and in addition, the new criteria also Comment: Insignificant medical tissus sensitivity to radiation. respond to previous public criticism events have been included in the post Comncent:The annual TEDE to any and to changes in other NRC regulations AO reports to Congress.

minor or ombryo/ fetus should be relating to radiation protection. Response:The NRC understands the reduced to Ns 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 mSv (5 rem), from the AO policy statement because policy before the revision. Because of Response:Tha NRC understands the the NRC does not have sufficient the low dose thresholds established in sensitivity of an unintended exposure to competence in medicine and pharmacy the previous criteria, medical events to determine public safety significance that have not had the potentialIo result a minor or an embryo / fetus and recognizes that the radiation health of medical events, in significant radiation consequences to effects e:e age dependent because Response: Because the NRC regulates patients were determined to be AOs and byproduct materialincluding the were reported to Congress. As a result, orpns and tissues in minors, fetuses, and embryos are more radiosensitive medical use of this material, criteria for the Commission is revising the AO than a typical adult. Therefore, a dose medical events have been developed criteria dose thresholds for medical and must be included in the AO policy events to exclude insignificant events.

l threshold of 50 mSv (5 rem) was est:blished for any minor or embryo / statement to comply with Section 208 of 111. Summary of Agreement State fetus, which is lower than the adult AO the Ene y Reorganization Act of 1974' Commenta and NRC's Response threshold of 250 mSv (25 rem). as amen ed. The revised criteria are based on widely accepted standards for Seven Agreement States submitted 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.

rem)is at or below the average dose that by the ACMUI.Therefore,the NRC SECY-94-275," Revised Abnormal believes that events exceeding the a person (including minors)in the criteria are sufficiently important to Occurrence Criteria. , These States were United States receives annuall frorn Arkansas, Georgia, Kentucky, New York, natural radiation and man.ma e sources inf rm Congress and the public. Texas. Tennessee,and Washington.

Comment: Congress may obtain as stated in the res onse to an earlier inf nnation on significant medical After evaluating the comments, several comment. The threshold established by events from the FDA instead of the NRC. were incorporated in the Commission NRC is below the minimum threshold paper. A summary of the Agreement Response: Section 208 of the Energy doses for permanent detenninistic Reorganir.ation Act of1974,as State comments applicable to the AO effects in selective organs for a minor or amended, requires reporting to Congress criteria listed in the proposed policy sn embryo / fetus' licensee events that the NRC determines statement as published in the FRN and Comment:The criteria elated to a to be significant from the standpoint of NRC's response are presented below:

nursing child, fetus, or embryo as r, result of an exposure to a nursing public health and safety. An enactment' AE d@, Reedste and/or oflaw would be necessary to chan se nunw hems oMe AO Reporung mother or pregnant woman should be this requirement and appoint anotke er deleted from the criteria until the agency such as the FDA to undertake proposed rule addressing these the AO responsibility. Comment: Four States commented on cxposures is resolved through the Comment: ACMUI should review the the specific guidelines of a prior advice of the Advisory Committee on medical AO criteria. revislon of the proposed appendix of the Medical Uses ofIsotopes (ACMUlj and Response:The revised criteria were AO report on "Otber Events of Interest" a separate public comment period. }rresented to ACMUI and comments or wanted "Other Events of Interest" Response:The NRC recognizes the received were incorporated before deleted. ,

lack of a specific regulation to address publishing them in the Federal Register Response:It snould be noted that the exposures as a result of an unintended (January 9,1996; 61 FR 661).Only section on "Other Events of Interest" aininistration of radioactive material to minor changes have been made to the contained in this final AO policy a patient that is pregnant or nursing. criteria since ACMUI's review. statement has been revised since the Based on NRC's experienm, some of Comment: Add a third condition to time that Agreement States provided these events have the potential for the medical AO criteria to read:"and (c) comments, and therefore comments on i significant health and safety is a radiation exposure that has resulted the specific guidelines of the section do consequences to a minor or an embryo / in unintended permanent functional not apply. In reference to the fetus and should be reported to damage to an organ or a physiological elimination of"Other Events of Congress. system as determined by a physician" to Interest." see NRC's response to the l

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{s 87076 Federal Register / Vol. 61, No. 245 / Thursday, December 19,'1996 / Notices L

not yet developed a regulation second public comment under Category establish a single-dose threshold value establishing a dose threshold for A. to identify doses to an occupational Comment:One State suggested that worker, a member of the public, and a reporting these events to the NRC.

wrong individual (wrong patient),2 Response: See response to fourth i the AO criteria should apply to which are significant from a health and public comment under Category B.

exposures from non-Atomic Energy Act (AEA) material. safety standpoint. The basis was that' s. IV. The Commission Policy-General Response: Section 208 of the Energy for the purpose of reporting to Congres Statement of Policy on implementation Reorganization Act of 1974, as the potential for physical harm to an of Section 208 of the Energy amended, provides that the Commission individual resulting from the Reorganization Act of 1974, as shall submit to Congress each yeal a umntended exposure is the same Am'"ded report listing for that period any AOs at whether the exposure was received in 1. APPli cability. Implementation of or associated with any facility which is an occupational setting, as a patient Section 208 of the Energy licensed or otherwise regulated who was not intended to receive a Reorganization Act of1974,as pursuant to the Atomic Energy Act of prescribed dose, or as a member of the amended, Abnormal Occurrence 1954, as amended, or pursuant to this public. Reports, involves the conduct of Act.Therefore,the AO criteria will not Comment:Three States suggested providing credentials for a " physician" Commission business and does not apply to events involving the use of Impose requirements on licensees.

non-AEA material since this material is as listed in criterion LA.3. Reports will cover certain unscheduled Response:For general purposes the not regulated by the NRC. incidents or events related to the Comment:One State commented that term " physician"is defined in to CFR manufacture, construction, or operation Part 35.2, where " Physician means a the AO policy statement imposes medical doctor or doctor of osteopathy of a facility or conduct of an activity additional requirements on licensees, subject to the requirements of Parts 20, Response:The AO policy statement licensed by a State or Territory of the will not change the reporting United States, the District of Columbia, 30 through 36,39,40,50,61,70,71,or requirements imposed on NRC licensees or the Commonwenith of Puerto Rico to 72 of Chapter I, Title 10, Code of F Regulations (10 CFR).

by Commission regulations, license prescribe drugs in the practice of medicine." Through an exchange of information, conditions, or technical specifications.

Although the NRC regulations do not Agreement States provide information The NRC licensees will continue to to the NRC on incidents and events submit required event reports. The AO specify the detailed credentials of a

" physician" for incident evaluation involving applicable nuclear materials criteria will only be used by the NRC Purposes, the NRC staff has developed that have occurred in their States. Those during internal review and evaluation events reported by Agreement States an NRC Inspection Manual Chapter for reporting significant events to (IMC 1360)"Use of Physicians and that reach the threshold for reporting as Congress. an AO are also published in the " Report Comment: One State commented that Scientific Consultants in the Medical ,

Consultant Program" that provides to Congress on Abnormal Occurrences."

criterion I.A.3 is arbitrary.

Response:The NRC disagrees, guidance on the use of NRC consultants 2. Definition of terms. As used in this Because 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 I.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 ensure timely and comprehensive that is licensed or otherwise regulated, functional damage to an organ or a review of medical events. IMC 1360 and pursuant to the Atomic Energy Act of physiological system at thresholds below those listed in the AO criteria. Management Directive 8.10 are available 1954, as amended, or the Energy llowever, the NRC believes that there in the NRC public document room,2120 Reorganization Act of1974,as amended, that the Ccmmission will be very few of those events. In most L Street, NW. (Lower level), determines to he significant from the cases permanent organ and Washington, DC 20555-0001.

standpoint of public health and safety; physiological damage will occur only at B. Be Consistent with the Regulations and doses above the proposed AO and Reconsider the Criterion for o i (b) an _ unintended radiat,on thresholds. Minor, or an Embryo / Fetus

- exposure, includes any occupational Comment:One State commented that exposure, exposure to the general Comment:One State commented that criterion I.D.3 is arbitrary. public, or exposure as a result of a Response:The NRC disagrees. Based the AO criteria should be consistent on NRC's experience, certain reported with 10 CFR Part 20. medical rnisadministration (as defined events, although they did not result in Response:To the extent practical, the in 3r 35.2) involving the wrong NRC has been consistent with 10 CFR individual that exceeds the reporting significant radiation consequences, had values established in the regulations.

the potential for adverse impacts on Part 20 and at the same time has established thresholds to include only All other reported medical public health and safety because of a events ttut have the potential to result misadministrations will be considered serious failure of the licensees's <

radiation protection program and lack of in deterministic effects due to for reporting as an AO under the criteria unintended exposures. for medical licensees. In addition, management control and oversight and Comment:Tv o States expressed unintended radiation exposures include should be reported to Congress. concern about developing an AO dose Comment: Two States commented any exposure to a nursing child, fetus, threshold for events regarding a minor- or embryo as a result of an exposure that " wrong patient" should be considered in the misadministration AO or an embryo / fetus since the NRC has (other than an occupational exposure to criteria instead of the general AO en undeclared pregnant woman) to a s in the Federal Resiseee notice dated septemter nursing mother or nregnant woman

- criteria applicable to all licensees.

Response:In the SRM of May 19, 2

y4 3{1o g

and 35. g.gg 1994, on SECY-93-259, the NRC staff Radioactive Materiat." the term -wrons patient"

3. Abnormaloccurrencegeneml was directed by the Commission to was replaced by the term "wrons indwidual." statement ofpolicy. The Commission

l l

Federal Register / Vol. 61. No. 245 / Thursday, December 19, 1996 / Notices 67077 u

will apply the following policy in will be considercd for reporting as AOs greater than the regulatory limits in to detemuni g whether an incident or are es follows: - CFR 71.511a)(2).

1. For All Licensees C. Theft. Diversion, or Loss of Licensed a iv t that is licensed or herwise Material, or Sabotage or Security reEulated by the Comn.ission is an AO A. Human Exposure to Radiation From Breach

• within the purview of Section 208 of the Licensed Material

• 1. Any lost, stolen, or abandoned Energy Reorganir.ation Act of 1974, as 1. Any unintended radiation exposure sources that exceed 0.01 times the Ai amended. to an adult (any individual 18 years of values, as listed in 10 CFR Part 71, l An incident or event will be  !

considered an AO if it involves a ma}or age or older) resulting in an annual total appendix A, Table A-1, for special form effective dose equivalent (TEDE) of 250 (sealed /nondispersible) sources, or the l reduction in the degree of protection of millislevert (mSv) (25 rem) or more; or smaller of the A2 or 0.01 times the A I

thi public health or safety. This type of an annual sum of the deep dose values, as listed in Table A-1, for I incident or event would have a equivalent (extemal dose) and normal form (unsealed /dispersible) l moderate or more severe impact on the committed dose equivalent (intake of sources or for sources for which the public health or safety and could .

radioactive material) to any individual include,but need not be limited to the form is not known. Excluded from following: organ or tissue other than the lens of the reporting under this criterion are those '

eye, bone marrow and the gonads, of events involving sources that are lost, ill Moderate exposure to, or release of, 2500 mSv (250 rem) or mom or an stolen, or abandoned under the a radioactive material licensed by or otherwise annual dose equivalent to the lens of the following conditions: sources renulated by the Commission; 121 Major degradation of essential safety. eye, of 1 Sv (100 rem) or more; or an abandoned in accordance with the rel:ted equipment; or annual sum of the deep dose equivalent requirements of to CFR 39.77(c); sealed 131 Mejor deficiencies in design, and committed dose equivalent to the sources contained in labeled, rugged construction. use of, or management controls bone marrow, and the gonads, of 1 Sv source housings; recovered sources with '

for licensed facilities or material. (100 rem) or more; or an annual sufficient indication that doses in excess Criteria by type of event used to shallow dose equivalent to the skin or of the reporting thresholds specified in det:rmine which incidents or events extremities of 2500 mSv (250 rem) or Ao criteria I.A.1 and I.A.2 did not occur will be considered for reporting as AOs more. during the time the source was missing; are set out in appendix A of this policy 2. Any unintended radiation exposure and unrecoverable sources lost under st:t: ment. , ,

to any minor (an individual less than 18 such conditions that dosos in excess of

4. Commission dissemination of years of age) resulting in an annual the reporting thresholds specified in A0  ;

pot:nfial AO ond AO information. TEDE of 50 mSv (5 rom) or more, or to criteria I.A.1 and I.A.2 were not known l I

,(a)The Commission will provide as an embryo / fetus resulting in a dose ' to have occurred.

wide a dissemination ofinformation to equivalent of 50 mSv (5 rem) or more. 2. A substantiated case of actual or i l

thz public as reasonably possible. 3. An radiation exposure that has attempted theft or diversion of licensed '

Information on tential AOs(events resulte in unintended permanent material or sabotage of a facility.

that may meet t e AO criteria) will be functional damage to an organ or a 3. Any substantiated loss of special sent to the NRC Public Document Room physiological system as determined by a nuclear rnaterial or any substantiated 1 and all local ublic document rooms as physician, inventory discrepancy that is judged to -

l soon as possi le after the staff be significant regative to normaggy det:rmines that the incident is a B. Discharge or Dispersal of Radioactive na l pot:ntial AO. A Federal Register notice Material From its Intended Place of Confinement ef[r ,db'b diofemion

{orby substantialbreafdown the will be issued on each AO re rt with copies distributed to the NR Public 1. The release of radioactive material accountability system.

Document Room and all local public 4. An substantialbreakdown of to an unrestricted area in concentrations document rooms. When additional which,if averaged over a period of 24 hysicaf security or material control

' h* " hours, exceed 5000 times the values fi.e. access control containment or il ate at t e in o tion ]n specified in Table 2 of appendix B to 10 accountability systems) that obt:Ined at the NRC Public Document CFR Part 20, unless the licensee has significant! weakened the protection Room and in all local public document demonstrated compliance with against the , diversion, or sabotage.

rooms 6 20.1301 using S 20.1302 (b) (1) or D. Other Events (i.e., Those concerning l (b) Each year, the Commission will 20.1302 (b)(2) (11). . Design. Analysis, Construction, Testing, i submit a report to Congress listing for l th t period any AOs at or associated 2. Radiation levels in excess of the Operation, Use, or Disposal of Licensed with any facility or activity which is design values for a package, or the loss Facilities or Regulated Materials) I licensed or otherwise regulated of confinement of radioactive material 1. An accidental criticality 110 CFR l pursuant to the Atomic Energy Act of resulting in one or more of the '

following:(a) A radiation dose rate of 10 70.52(a)).

1954, as amended, or the Energy 2. A rne,or j deficiency in design, Reorganir.ation Act of 1974, as mSv (1 rem) per hour or more at 1 meter construction, control, or operstwn arnended. This report will contain the (3.2B feet) from the accessible extemal date, place, nature, and probable surfaw of a package containing radioactive material;(b) a radiation dose *taformation putainigo cwtain incidents may consequence of each AO,the cause or c:uses of each AO, and any action taken rate of 50 mSv (5 rem) per hour or more $"c,CI',"$d

, ,e " bu In ujn on the accessible external surface of a impucauons cuisined infonnation will be to prevent recurrence, package containing radioactive material withheld when formally reportins these incidents l in accordance with S*ction 20s of.the Energy Appendix A-Abs.ormalOccurrence and that meet the requirements for Criteria " exclusive use" as defined in 10 CFR Rewganizauon Act ohn as amended Any ih n d.nt wou gl

" d Criteria by types of events used to 71.47; or (c) release of radioactive N.),rgi ., u ,t nd material from a package in amounts appropriate curity arrange,nents. l determine which incidents or events

a.

~~

e

.e,'

87078 Federal UC / Vol. 61, No. 245 / Thursday, December 19, 1996 / Notices having significant safety implications (a) Results in a dose that is (1) equal requiring immediate remedial action. to or greater than 1 grey (Gy)(100 reds) 3 A serious deficiency in to a major portion of the bone marrow, snanagement or procedural controls in to the lens of the eye, or to the gonads,

< major areas. or (2) equal to or greater than to Gy (1000 rads) to any other organ; and

4. Series of events (where individual

• events are not of major importance), (b) Represents either (1) a dose or securring incidents, and incidents with dosage that is at least 50 percent greater e

implications for similar facilities than that prescribed in a written I directive or (2) a prescribed dose or (generic incidents) that create a major

)* safety concern. dosage that (i)is the wrong radiopharmaceutical,5 or (ii) is delivered I 11 For Commercio! Nuclear Pcver Plant by the wrong route of administration, or

1. UC " *'8 (iii) is delivered to the wrong treatment A. Malfunction of Facility, Structures, site, or (iv) la deliverr,d by the wrong

treatment mode, or (v) is from a leaking or Equipment source (st

1. Exmeding a safety limit oflicense technical specification (TS) Il 50.36(c)l. V. Guidelines for "Other Events of

2. Serious degradation of fuel Interest" integrity, primary coolant pressure The Commission may determine that boundary, or primary containment events other than AOs may be ofinterest to Congress and the public and be boundary,

3. Loss o f plant capability to perfonn ndix to the AO 1

essential safety functions so that a included in an ap[ents ofinterest."

report as Other release of radioactive materials, which Guidelines for events to be included in

could result in exceeding the dose limits the AO report for this purpose are items of to CFR Part 100 or 5 times the dose limits of to CFR Part 50, appendix A, that "blicmayto of bossibly health or safet be perceived by the General Design Criterion (GDC) could occur from a postulated tran 19'sient fignificance. Such items woufd not involve a major reduction in the level of or accident (e.g., loss of eme enc core protection provided for public health or cooling system, loss of contro r would not b safety; therefore, thef occurrences.e reported as abnorma An

'Y 8"I*

B. Design or Safety Analysis Deficiency, example la an event where upon final Personnel Error, or Procedural or evaluation by an NRC Incident Administrative inadequacy Investigation Team, or an Agreement State equivalent response, a

1. Discovery of a major condition not determination is made that the event specifically considered in the safety does not meet the criteria for an analysis report (SAR) or TS that requires abnormal occurrence.

immediate remedial action.

2. Personnel error or procedural og$',d, *h"fg* , lema @and, this 13th

[ day deficiencies that result in loss of lant For the Nuclear Regulatory Commission.

capability to perform essential sa ety N C#*N

functions so that a release of radioactive 8'C"*'T l'h' C***i883 "-

materials, which could result in IFR Doc. 96-32210 Filed 12-18-96; 8:45 aml exceeding the dose limits of to CFR Part 100 or 5 times the dose limits of to CFR e .tsuo caos tese ow Part 50, appendix A,GDC 19, could occur from a postulated transient or accident (e.g., loss of emergency core cooling system, loss of control rod systeml.

IIL For Fue's Cycle Licensees

1. A required plant shutdown as a result of violating a license condition or other safety limit.

j 2. A major condition not specifically I considered in the license that requires immediate remedial action.

3. An event that seriously compromises the ability of a #

connnement system to perform its

'Th' '*d'aP harmacautic*l ** **'*d la 'h*

- designated function. A0 crit a for medical misedministrations refers to enr radiopharmaceutical other than the one IV,ForMedico1 Licensees listeef in the written directive or in the clinical A medical migadministration that: procedures manual

._