ML20134B897

Requests Commission Approval to Publish Final Policy Statement That Includes Revised Abnormal Occurrence Criteria to Be Used by NRC & Agreement State Staff

ML20134B897
Person / Time
Issue date:	09/04/1996
From:	Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
References
SECY-96-193, SECY-96-193-R, NUDOCS 9609120157
Download: ML20134B897 (46)

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POLICY ISSUE September 4, 1966 SECY-96-193 g

g FOR:

The Commissioners FROM:

James M. Taylor Executive Director for Operations

SUBJECT:

ABNORMAL OCCURRENCE REPORTS: IMPLEMENTATION OF SECTION 208 ENERGY REORGANIZATION ACT OF 1974; FINAL POLICY STATEMENT PURPOSE:

To obtain Commission approval to publish the final policy statement that includes revised abnormal occurrence criteria to be used by NRC and Agreement State staff.

BACKGROUND:

In the Staff Requirements Memorandum (SRM) dated November 27, 1995, SECY 244, the Commission approved publication in the Federal Recister of the proposed revised abnormal occurrence (AO) criteria. The revision includes changes to the misadministration A0 criteria and provides consistency with recent changes in NRC regulations.

It is consistent with the Commission's initial guidance provided in SRMs dated January 30, 1992; May 19, 1994; February 21, 1995; June 29, 1995; and November 27, 1995. These SRMs included the following Commission guidance:

The changes made to the NRC's amended 10 CFR Part 20 should be taken into consideration for the revision of the A0 criteria (SRM dated May 19, 1994, on SECY-93-259).

NOTE: TO BE MADE PUBLICLY AVAILABLE WHEN THE FINAL SRM IS MADE AVAILABLE

Contact:

Harriet Karagiannis, AE0D 415-6377 0

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e A single-dose threshold value should be established to identify doses to an occupational worker, a member of the public, and a wrong individual,' that are significant from a health and safety standpoint (SRM dated May 19, 1994, on SECY-93-259).

Multiple misadministrations should not be considered as A0s unless they result in significant potential for harm to individuals (SRM dated May 19, 1994, on SECY-93-259).

e The A0 report to Congress should have a section entitled "Other Events of Interest" to include events of broad public interest that require significant regulatory attention and do not meet the A0 criteria (SRM dated June 29, 1995, on SECY-95-083).

e The Commission approved publication of the proposed revision to the A0 policy statement for public comment including "Other Events of Interest" (SRM dated November 27, 1995, on SECY-95-244).

The Agreement States and the Advisory Committee on the Medical Uses of Isotopes (ACMUI) were provided an early opportunity to submit comments on the proposed A0 criteria and the proposed specific guidelines of the section on "Other Events of Interest." At Agreement State meetings and workshops, the States provided substantial comments on the A0 criteria including negative comments on the guidelines for "Other Events of Interest" and recommended elimination of this section on the basis of no legal justification and because it is an unnecessary expenditure of the already strained Agreement State resources.

Written comments were submitted by seven Agreement States:

Arkansas, Georgia, Kentucky, New York, Texas, Tennessee, and Washington.

These comments were evaluated and several were incorporated in SECY-94-275,

" Revised Abnormal Occurrence Criteria" that provided the Commission a draft of the revised A0 criteria as requested in an SRM dated May 19, 1994.

The staff revised the section on "Other Events of Interest" as directed by the Commission and published the proposed policy statement " Abnormal Occurrence Reports:

Implementation of Section 208 Energy Reorganization Act of 1974; Proposed Policy Statement" (Attachment 1) in the Federal Reaister on January 9, 1996 (61 FR 661). The Federal Reaister notice (FRN) included the revised "Other Events of Interest" (Attachment 1, page 669) and called for a 90-day public comment period.

Because the published FRN did not differ significantly from that discussed with the Agreement States or ACMUI, no additional comments were received from either group.

DISCUSSION:

Five letters of comment were submitted to the NRC on the proposed A0 policy statement as published in the Federal Reaister (January 9, 1996; 61 FR 661).

The staff has reviewed the public comments and prepared the attached FRN (Attachment 2) which addresses the public comments and announces the " Abnormal Occurrence Reports:

Implementation of Section 208 Energy Reorganization Act of 1974; Final Policy Statement."

' in the Federal Reoister notice dated September 20,1995 (60 FR 48623), *10 CFR Parts 20 and 35, Medical Administration of Radiation and Radioactive Material

• the term

• Wrong patient" was replaced by the term

• Wrong individual."

I 3

The majority of the comments supported the approach that the staff has taken to revise the criteria and offered specific comments.

Each letter listed more i

than one comment and they are categorized into three groups: 1) modify and/or discontinue the A0 reporting process; 2) revise the dose threshold for i

reporting A0 events to Congress on unintended exposures to an adull and a minor or an embryo / fetus; and 3) rewaluate the A0 criteria applicable to medical licensees. There was only one public comment on "Other Events of i

Interest" suggesting its deletion.

i The final policy statement also addresses a summary of the written comments provided by the Agreement States on an earlie* A0 revision before the proposed j

policy statement was published (January 9, 1996; 61 FR 661). These comments j

are categorized into two groups: 1) modify, reevaluate, and/or discontinue items of the A0 reporting process; and 2) be consistent with the regulations and reconsider the dose threshold for a minor, or an embryo / fetus.

Four States provided comments on "Other Events of Interest" suggesting its deletion.

There is no substantive change to the proposed final A0 policy statement. One change'was made to the pneral A0 criterion I.A.1, " Human Exposure to Radiation from Licensed riaterial" applicable for all licensees, revising the proposed A0 dose threshold to the lens of the eye, bone marrow, and gonads, based on a public comment and further staff consideration of the deterministic effects to these organs (Attachment 2, II. Summary of Public Comments and the NRC's Response, section B, first comment).

COORDINATION:

The Office of the General Counsel (0GC) has reviewed the final policy statement and has no legal objection.

In addition, 0GC has advised the staff that the A0 policy statement is not a " rule" under the "Small Business Regtlat% Enforcement Fairness Act" because it establishes agency practice and procedare in the area of A0 reporting and does not substantially affect the right, and obligations of non-agency parties.

RECOMMENDATION:

The staff recommends that the Commission approve the attached final policy statement on " Abnormal Occurrence Reports:

Implementation of Section 208 Energy Reorganization Act of 1974; Final Policy Statement" including the A0 policy statement section on "Other Events of Interest" to be published in the Federal Reaister.

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f67 or E ecutive irector for Operations Attac'hments:

1.

Published A0 Policy Statement (FRN Vol. 61, No. 6, January 9, 1996) 2.

Proposed Federal Reaister Notice

4 D

Commissioners' comments or consent should be provided directly to the Office of the Secretary by COB Thursday, September 19, 1996.

Commission Staff Office comments, if any, should be submitted to the Commissioners NLT September 12, 1996, with an information copy to the Office of the Secretary.

If the paper is of_such a nature that it requires additional review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected.

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Fed:r;] Register / Vol. 61. No. 6 / Tuesday, January 9,1996 / Notices 661 i

to report on ongoing Council initiatives, and events that the Commission (4) Any action taken to prevent

)

and to plan for future directions.

considers significant from the recurrence.

Dated: January 4,1996, standpoint of public health and safety The Commission shall also provide as j

Sandra Perlmutter for reporting to Congress, and to make wide dissemination to the public of the 1

Executive Director, President's Council on the AO policy consistent with recent information specified in clauses (1) and j

Physicof fitness andSports.

changes to NRC regulations. The revised (2) of this section as reasonably possible j

wh y @f each AO and shall Ms Mkg a n ain mom hte

[FR Doc.96-288 Filed 1-6-96; 8:45 ami information o reporting thresholds making them easier to use and ensuring more consistent Provide as wide dissemination to the

- - - application of the intended AO Public as reasonably possible of the reporting policy set forth by the information specified in clauses (3) and i

DEPARTMENT OF THE INTERIOR Commission.

(4) as soon as such information becomes i

availa DATES:The public comment period on Bureau of 1.and Management this roposed pohcy statement ends

)uly 9 5,in the exercise of the (CA-083-1150-00)

Apri 8,1996. Comments received after authority conferred upon the the public comment period will be Commission by Congress to determine which unscheduled incidents or events Cancellation of Public Workshops for addressed ifit is practicable to do so' j

the Northern and Eastern Colorado but the Commission is able to ensure are significant from the standpoint of Desert Cooroinated Management Plan consideration of only those comments Public health and safety and are reportable to Congress as AOs, the The following public meetings received on or before the last day of the announced in the Federal Register will comment period.

Commission developed interim criteria for evaluating licensee incidents or not be held because of the furlough of ADDRESSES: Send comments to:

events. On the basis of these interim

. BLM employees during the partial Secretary, U.S. Nuclear Regulatory criteria and as required by Section 208, I'

shutdown of the Federal governmant:

Commission, Washington DC 20555, the Commission began issuing quarterly January 8, Riverside Attn: Docketing and Service Branch.

reports to Congress on AOs. These

~l January 9, Long Beach Iland deliver comments to 11555 reports 8 " Report to Congress on i

January 10.Twentynine Palms Rockville Pike, Rockville, Maryland, Abnormal Occurrences," have been l

January 11 Palm Springs between 7:45 a.m. and 4:15 p.m. Federal issued in NUREG 75/090 and NUREG-I 4

I January 16, Needles workdays.

0090-1 through 5 for the period from January 17, Blythe Examine comments received at the January 1975 through September 1976.

January 18, El Centro NRC Public Document Room,2120 L On the basis ofits experience in the January 22. Rancho Bernardo Street NW (Lower Level), Washington, preparation and issuance of AO reports, DC.

For More Infonnation: Contact the the Commission issued a general Bureau of Land Management, California FOR FURTHER INFORMATION CONTACT:

statement of policy that described the Desert District. External Affairs Office, Harriet Karagiannis, Office for Analysis manner in which it will, as part of the 6221 Box Springs Boulevard, Riverside, and Evaluation of Operational Data. U.S.

routine conduct ofits business, carry l

California 92507,(909) 697-5217.

Nuclear Regulatory Commission, out its responsibilities under Section Dated:I""""#I 3* I" Washington, DC 20555, telephone: (301) 208 of the Energy Reorganization Act of f

415-6377.

1974, as amended, for identifying AOs

-"A s rict ManoBer-SUPPLEMENTARY INFORMATION:

concernmg each such occurrence J

(FR Doc.96-278 Filed U-8-96: 8:45 aml

Background

available to Congress and the public in Section 208 of the Energy a timely manner. This general statement I olicy was published in the Federal P

Reorganization Act of 1974 (Public law 93-438, 42 U.S.C. 5848), as amended, Register on February 24,1977 (Vol. 42, i

NUCLEAR REGULATORY provides that:

No. 37, pages 10950-10952) and COMMISSION The Commission shall submit to Provides enteria and examples of types fmn3s determm,that the Commission uses in Abnormal Occurrence Reports:

Congress each quarter a report listing for mg whether a particular event implementation of Section 208 Energy that period any AOs at or associated with any facility which is licensed or is reportable to Congress as an AO. The

, l Reorganization Act of 1974; Proposed i

Commission has since refined this i

Policy Statement otherwise regulated pursuant to the Atomic Energy Act of 1954, as amended, statement of policy on a number of

" s ons AGENCY: Nuclear Regulatory or pursuant to this Act. For the purposes y 9n an Po Cy t e basis of Commission, of this Section,an AOis an AcnON: Proposed policy statement.

""Sched"I*d inca' dent or event which these criteria, and as required by the Comm.ission has determmed to be Section 208 of the Ene'EY

SUMMARY

This policy statement significant from the standpoint of public Reorgamzadon Act of1974,as amended, the Commission has issued presents the revised criteria the health and safety. Nothinfimit the 9.uarterly reports to Congress on AOs in the Preceding sentence shall Commission is considering for use in submitting the quarterly abnormal authority of a court to review the smce March 1977. These reports, occurrence (AO) reports to Congress and determination of the Commission. Each the public in a timely manner as stated such report shall contam:

' copies of the NUREG-4090 series may tw obiained from the superiniendent of Documents, in Section 208 of the Energy (1) The date and place of each u.s. covernment Printins omce. Mail Stop SSOP, Reorganization Act of1974,as occurrence; washington. DC 20402-9328. the National rech ini i s 5p y.i amended.The AO policy statement has (2) The nature and probable gQi pn jn:

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been revised to provide more specific consequence of each occurrence; Document Room. 2220 t. street. NW (tower LeveU.

criteria for determining those incidents (3) The cause or causes of each; and washington, oc. 20o27

662 Federal Register / Vol. 61. No. 6 / Tuesday, January 9,1996 / Notices

" Report to Congress on Abnormal Commission considers significant from revise the policy statement accordingly Occurrences " have been issued in the standpoint of public health and and then resubmit it to the Commission NUREG-0090-6 through to and safety. The policy reflects a range of for final approval. The policy statement NUREG-0090, Volumes 1 through 18.

health and safety concerns and is is currently scheduled to be presented i

Based on its experience to date in the applicable to incidents and events to the Commission for final approval l

preparation and issuance of AO reports, involving a single occupational worker during the summer of 1996.

th Commission has decided that its as well as those having an overall a

responsibilities under Section 208 can act on the general publicc Genwal Staternent of Policy on j

imfhe policy statement contains criteria hs carried out more appropriately if the l

imp ementation Enugy Reorgam,of Section 208 of the existing AO criteria are updated to that include the reporting thresholds for zation Act of1974, as reflect changes in the Commission's determining those incidents and events Amended policy and changes to the regulations.

that are reportable by NRC for the

1. Applicobility-Implementation of Accordingly, the Commission is issuing purposes of Section 208 of the Energy Section 208 of the Energy this general statement of policy that Reorganization Act of1974,as Reorganization Act of1974,as describes the manner in which the amended.The Commission has amended. Abnormal Occurrence Commission will, as part of the routine established the reporting thresholds at a Reports, involves the conduct of i

conduct of its business, carry out its level which will assure that till events Commission business and does not responsibilities under Section 208 of the that should be considered for reporting impose requirements on licensees.

Energy Reorganization Act of 1974, as to Congress will be identified. At the ' Reports will cover certain unscheduled amended, for identifying AOs and same time, the thresholds are generally incidents or events related to the j

making the requisite information above the normal level of reporting to manufacture, construction, or operation concerning each such occurrence NRC to exclude those events which of a facility or conduct of an activity available to Congress and the public in involve some variance from regulatory subject to the requirements of Parts 20, a timely manner. Included in the policy limits, but are net significant from the 30 through 36, 39, 40, 50, 61, 70, 71, or statement are criteria that the standpoint of public health and safety, 72 of Chapter I, Title 10. Code of Federal Commission will use in determining whether a particular event is a 1.icensee Reports Rebulations (10 CFR).

nder an exchange ofinformation reportable AO within the meaning of This general statement of policy will program Agreement States provide Section 208. It is expected that as not change the reporting requirements information to NRC on incidents and additional experience is gained, changes imposed on NRC licensees by events involving applicable nuclear in the criteria may be required.

Commission regulations, license materials that have occurred in their conditions, or technical specifications States. Those events reported by Paperwork Reduction Act Statement (TS). NRC licensees will continue to Agreement States that reach the This proposed policy statement does submit requirest reports on a wide threshold for reporting as an AO are also not contain a new or amended spectrum of events, including events published in the quarterly " Report to information collection requirement such as instrument malfunctions and Congress on AbnormalOccurrences."

subject to the Paperwork Reduction Act deviations from normal operating

2. Definition of terms-As used in this of 1995 (44 U.S.C. 3501 et seq.). Existing Procedures that are not significant from policy statement:(a) An abnormol requirements were approved by the the standpoint of the public health and occurrence means an unscheduled Office of Management and Budget, safety but which provide data useful to incident or event at a facility or approval 3150-0014,10 CFR Part 20; the Commission in monitoring operating associated with an activity that is i

3150-0017,10 CFR Part 30;3150-0016, trends oflicensed facilities and in licensed or otherwise regulated, l

to CFR Part 31; 3150-0001, to CFR Part comparing the actual performance of pursuant to the Atomic Energy Act of 32; 3150-0015,10 CFR Part 33;3150_

these facilities with the potential 1954, as amended, or the Energy 0007,10 CFR Part 34; 3150-0010.10 performance for which the facilities Reorganization Act of1974,as CFR Part 35; 3150-0158,10 CFR Part 36; were designed and/or licensed.

amended, that the Commission 3150-0130,10 CFR Part 39;3150-0020, Information pertaining to all events determines to be significant from the 10 CFR Part 40; 3150-0011,10 CFR Part reported to NRC will continue to be standpoint of public health and safety; 50; 3150-0135,10 CFR Part 61; 3150-made available and placed in the public and (b) an unintended rodiotion 0009, to CFR Part 70; 3150-0008,10 document rooms for public perusal. In exposure includes any occupational CFR Part 71; and 3154-0132,10 CFR addition, NRC publishes annual reports exposure, exposure to the general Put 72; 3150-0002,10 CFR Part 73; and on events (NUREG-1272 series).

public, or exposure as a result of a 3150-0093,10 CFR Part 100.

Information can also be obtained by medical misadministration (as defined Public Protection Notification writing to the U.S. Nuclear Regulatory in 10 CFR 35.2) involving the wrong Commission, Public Document Room, individual that exceeds the reporting The NRC may not conduct or sponsor, Washington, DC 20555. In addition, the values established in the regulations.

and a person is not required to respond Commission will continue to issue news All other reported medical to, a collection of information unless it announcements on events that seem to misadministsations will be considered displays a currently valid OMB control be newsworthy whether or not they are for reporting as an AO under the criteria number reported as ads.

for medical licensees. In addition, The Commission invites all interested unintended radiation exposures include Abnormal Occurrence Reportmg persons who wish to submit written any exposure to a nursing infant, fetus.

The general statement of policy has comments or suggestions on the AO or embryo as a result of an exposure been developed to comply with the criteria in this policy statement. A (other than an occupational exposure to legislative intent of Section 208 of the period of 90 days from the date of an undeclared pregnant woman) to a Enrrgy Reorganization Act of 1974, as publication has been established for nursing mother or pregnant woman.

uninded, to keep Congress and the receiving comments pertaining to this

3. Abnormoloccurrencegeneral public informed of unscheduled proposed policy statement. The NRC statement of policy--The Commission incidents or events which the staff will analyze all comments and will apply the following policy in

~

Federal Register / Vol. 61, No. G / Tuesday, January 9,1996 / Notices 003 ditermining wh:ther an incident or

1. Any unintended r:diation exposure

1. Any lost, stolin, or abandoned event at a facility or involving an to an adult (any individual 18 years of sources that exceed 0.01 times the Ai activity that is licensed or otherwise age or older) resulting in an annual total values, as listed in 10 CFR Part 71, regulated by the Commission is an AO effective dose equivalent (TEDE) of 250 Appendix A, Table A-1, for special within the purview of Section 208 of the millisievert (mSv) (25 rem) or more: or fona (sealed /nondispersible) sources, or Energy Reorganization Act of 1974, as the sum of the annual deep dose the smaller of the A2 or 0.01 times the

amended, equivalent and committed dose Ai values, as listed in Table A-1, for An incident or event will be equivalent to any individual organ or normal form (unsealed / dispersible) considerod an AO ifit involves a major tissue, other than bone marrow, the lens sources or for sources for which the reduction in the degree of protection of of the eye, or gonads of 2500 mSv (250 form is not known. Excluded fmm the public health or safety. Such an rem) or more; or an annual dose reporting under this criterion are those incident or event would have a equivalent to bone marrow, the lens of events savolving sources that are lost, moderate or more severe impact on the the eye, or gonads of 500 mSv (50 rem) stolen, or abandoned under the public health or safety and could or more; or an annual shallow-dose following conditions: sources include but need not be limited to the equivalent to the skin or extremities of abandoned in accordance with the following:

2500 mSv (250 rem) or more.

requirements of 10 CFR 39.77(c); sealed (1) Moderate exposure to, or release

2. Any unintended radiation exposure sources contained in labeled, rugged of, radioactive material licensed by or to any minor (an individual less than 18 source housings; recovemd sources with otherwise regulated by the Commission; years of age) resulting in an annual sufficient indication that dc.,es in excess (2) Major degradation of essential TEDE of 50 mSv (5 rem) or more, or to of the reperting thresholds specified in safety-related equipment; or an embryo / fetus resultmg in a dose AO criteria LA.1 and LA.2 did not occur (3) Major deficiencies in design, equivalent of 50 mSv (5 rem) or more.

during the time the source was missing-I 1

msult[in unintendradiation exposure that has and unrecoverable sources lost under j

3. A construction, use of, or management permanent such conditions that doses in excess of 1

controls for licensed facilities or material functional, damage to an organ or a the reporting thresholds specified in AO P ysiol cal system as determmed by a criteria I.A.1 and LA.2 were not known h

Criteria by type of event used to determine which incidents or events Ph m have occurred.

will be considered for reporting as AOs Radioactivo Material from its Intended

2. A substantiated, case of actual or j

are set out in Appendix A of this policy Place of Confinement:

attempted theft or diversion of hcensed i

1. The release of radioactive material matenal or sabotage of a facility.

statement.

4. Commission dissemination of AO to an unrestricted area in concentrations

3. Any substantiated loss of special l

infonnation, which,if averaged over a period of 24 nuclear material or any substantiated (a) The Commission will provide as

' hours, exceed 5000 times the values irwentory discrepancy that is judged to wide a dissemination ofinformation to specified in Table 2 of Appendix B to be signifiumt relative to normally the public as reasonably possible. A 10 CFR Part 20, unless the licensee has expected performance, and that is Federal Register notice will be issued clamonstrated compliance with 10 CFR judged to be caused by theft or diversion on each AO with copies distributed to 20.1301 using 20.1302(b)(1) or or by substantial breakdown of the the NRC Public Document Room and all 20.1302(b)(2)(ii).

accountability system.

local public document rooms. When

2. Radiation levels in excess of the

4. Any substantial breakdown of additional infonnation is anticipated, design values for a package, or the loss P ysical security or materia.1 control h

the notice will state that the information of confinement of radioactive material (i.e., access control containment or can be obtained at the NRC Public resulting in one or more of the accountabihty systems) that Document Room and in alllocal public following: (a) A radiation dose rate of 10 significantly weakened the protection document rooms.

mSv (1 rem) pu hour or more at 1 meter against theft, diversion, or sabotage.

(b) Each quarter, the Commission will (3.28 feet) from the accessible external D. Other Events (i.e., those concerning submit a report to Congress listing for surface of a package containing design, analysis, construction, testing, that period any AOs et or associated radioactive material. (b) a radiation dose operation, use, or disposal of licensed with any facility or activity which is rate of 50 mSv (5 rem) per hour or more facilities or regulated materials):

licensed or otherwise regulated on the accessible external surface of a

1. An accidental criticality (10 CFR pursuant to the Atomic Energy Act of Package containing radioactive material 70.52(a)).

1954, as amended, or the Energy and that meet the requirements for

2. A major deficiency in design, i

l Reorganization Act of 1974, as

" exclusive use" as defined in 10 CFR construction, control, or operation 6

amended. This report will contain the 71.47, or (c) release of radioactive having significant safety implications I

date, place, nature. and probable material from a package in amounts requiring immediate remedial action.

consequence of each AO, the cause or greater than the regulatory limits in to

3. A serious deficiency in causes of each AO, and any action taken CFR 71.51(a)(2).

management or procedural controls in I

to prevent recurrence.

C. Theft Diversion, or Loss of major areas.

Licensed Material, or Sabotage or

4. Series of events (where individual i

Appendix A-AbnormalOccurrence Security Breach 2:

events are not of major importance),

recurring incidents, and incidents with la'"m'ua" P""aining to censin iricidenis may implications for similar facilities

$,'*[i$"c '3,',"$","jd" j,d,'y," '"

Criteria by types of events used to l

determine which incidents or events (generic incidents) that create a major i

,c 6

willbeconsidered forreportingas AOs implications. classified information witi be safety concern.

j am as follows:

withheld when formally reporting these incidents in accordance with Section zoo of the energy

11. For Commercial Nuclear Power Plant I. For All Licensees Reorganization Act of 1974, as amended. Any Licensees A. Human Exposure to Radiation from N[Neiolh C A. Malfunction of Facility, Structures, upon r u un r Licensed Materiah apprepriate security arrangements, or Equipment:

664 Federal Register / Vol. 01. No. 6 / Tuesday. lanuary 9.19m / Notices

1. Exceeding a safety limit of license by the wrong route of administration. or potential AOs to the Commission is TS [10 CFR 50.36(c)).

(iii) is delivered to the wrong treatment important and regt. ires established

2. Serious degradation of fuel site, or (iv) is delivered by the wrong reporting thresholds whenever integrity, primary coolant pressure treatment mode, or (v)is from a leaking practicable. These reporting thresholds I

boundary, or primary containment source (s).

were selected with the intent of boundary.

3. Loss of plant capability to perform V. Guidelines for "Other Events of capturing the majority of the significant events and elimmatmg nonsigmficant essential safety functions such that a events from those to be proposed to the release of radioactive materials, which The Commission may determine that Commission.

could result in exceeding the dose limits events other than AOs may be of interest An additional criterion has been of 10 CFR Part 100 or 5 times the dose to Congress and be included in an added for those uncommon significant limits of to CFR Part 50, Appendix A.

A pendix to the AO report as "Other events that could occur without P

General Design Criterion (GDC) 19 Events ofInterest". Guidelines for triggering a reporting threshold. This could occur from a postulated transient events to be included in the AO report new criterion would require radiation or accident (e.g., loss of emergency core for this purpose are as follows:

exposures that have resulted in cooling system, loss of control rod Items that may possibly be perceived unanticipated permanent functional system).

by the public to be of health or safety damage of an organ or physiological B. Design or Safety Analysis '

significance. Such items do not involve system, as determined by a physician, Deficiency, Personnel Error, or a major reduction in the level of be reported to Congress. See Criterion Procedural or Administrative Protection provided for public health or 1.A.3 in Appendix A.

Inadequacy:

safety; therefore, they are not reportable The pohcy statement has also been

1. Discovery of a major condition not as abnormal occurrences. An example is revised to include changes that have specifically considered in the safety an event where upon final evaluation by been made to the re6ulations.

an11ysis report (SAR) or TS that requires an NRC Incident investigation Team, or The revised critena have been applied immidiate remedial action.

an Agmement State equivalent response, to events previously considered as

2. Personnel error or procedural a determination is made that such event potential AOs to ensure that the new deficiencies that result in loss of plant does not meet the criteria for an criteria will identify significant events capability to perform essential safety abnormal occurrence.

and eliminate nonsignificant events functions such that a release of Supplemental Information-Bases for from those to be proposed to the radioactive materials, which could Revised AbnormalOccurrence Commission. A similar review of events result in exceeding the dose limits of 10 Reporting Policy Statement involving 1 st, stolen, and abandoneo CFR Part 100 or 5 times the dose limits source events has also been performed.

1. Discussion-The AO reporting of 10 CFR Part 50, Appendix A GDC 19, could occur from a postulated transient Policy has been developed to comply " The results of these reviews were documented in Attachments 2, and 3 to or cccident (e g., loss of emergency core with the legislative intent,of Section 208 the Commission paper, SECY-95-083, cooling system, loss of control rod of the Energy Reorganization Act of

" Revised AbnormalOccurrence system).

1974, as amended, to keep Congress and Criteria." dated April 5,1995.

the public informed of unscheduled

2. Definition of terms-Terms relating 111. For Fuel Cycle L,censees incidents or events which the to the bases for the AO reporting criteria

t. A required plant shutdown as a Commission considers significant from are defined as follows:

result of violating a license condition the standpoint of public health and (a) Nonstochastic eIfects are those saf ty limit.

safety. The policy reflects a range of health effects, the severity of which

2. A major condition not specifically health and safety concerns related to varies with the dose, and for which a considered in the SAR or TS that production and utilization facilities and threshold is believed to exist. Radiation-requires immediate remedial action.

the possession and use of byproduct, induced cataract formation is an

3. An event that seriously source, and special nuclear. materials example of a nonstochastic effect (also compromises the ability of a licensed or otherwise regulated called deterministic effect). [10 CFR.

confinement system to perfonn its pursuant to the Atomic Energy Act of 20.1003) designated function.

1954, as amended, or to the Energy (b) Stochastic effects are those health Reorganization Act of1974, as effects that occur randomly and for IV. ForMedicalL.censees amended. These safety concerns can which the probability of the effect A medical misadministration that:

include events ranging from an occurring, rather than its severity. is (t) results in a dose that is (1) equal overexposure of a single occupational assumed to be a linear function of dose to or greater than 1 gray (Gy) (100 rads) worker to those having an overall without threshold. Hereditary effects i

to a major portion of the bone marrow, impact on the general public.

and cancer incidence are examples of to the lens of the eye, or to the gonads.

The revised policy statoment provides stochastic effects. (10 CFR 20.1003]

or(2) equal to or greater than 10 Gy a more usable policy for determining (c) Threshold dose denotes the (1000 rads) to any other organ: and which events will be reported to amount of radiation below w!uch no (b) represents either (1) a dose or Congress as AOs. The revised AO effect under consideration is likely to dosage that is at least 50 percent greater criteria in Appendix A contain more occur. Threshold dose is applicable to than that prescribed in a written discrete reporting thresholds than those deterministic effects, directive or(2) a prescribed dose or previously provided in the examples of (d) Reporting threshold denotes a dosage that (i)is the wrong AOs for easier and consistent discrete value at or above which an radiopharmaceutical.2 or (ii)is delivered application of the provisions established occurrence will be considered for by the policy statement for reporting to reporting as an AO.

• Tim wrons radiopharmaceutical as used in the Congress.

3. Abnormaloccurrence criteria-

^0 cri*ia for n= dical misadministratimmf" The consistent application of the AO The AO criteria provide the reporting isSIiNt7 Ni or t hId sn stic criteria by the staff, Agreement States, threshold for determining those events

~

cliniejprocedures manual and licensees for proposing events as that are reportable for purposes of

Federil Reght:r / Vol. 61, No. 6 / Tuesday, January 9,1996 / Notices 665 Section 208 of tha Energy adult (18 years of ag3 and older) lens of the eye. [NCRP Commentary No.

Reorganization Act of 1974, as resulting in an annual TEDE of 250 mSv 71 amended.The Commission has (25 rem) or more, is based on the e it is below the threshold dose for established criteria that contain following:

permanent sterility from a single dose to reporting thresholds intended to a It is greater than the regulatory the gonads. [NCRP Commentary No. 7]

Identify those events that are likely to be allowable TEDE limit (50 mSv 15 reml)

(d) The reporting threshold for an significant from the standpoint of public for annual occupational expot,ure unintended annual shallow-dose health and safety. At the same time, the established in 10 CFR 20.1201(a)(1)(i).

equivalent to the skin or extremities AO mporting thresholds established by

• It is equal to the generally accepted (extremities include the hand, elbow, the. criteria are generally above the level of exposure that is considered by arm below the elbow, foot, knee, leg normal level of reporting events to NRC the industry to be a significant below the knee) of an adult, resulting in to exclude those events which involve unplanned occupational overexposum.

2500 mSv (250 rem) or more is based on some variance from regulatory limits,

• It is at a level of exposure for which the following:

but are not significant enough from the the potential for morbidity is considered

• It is greater than the allowable standpoint of public health and safety to for individuals with an increased organ regulatory limit (500 mSv 150 reml) for be reported to Congress.

and tissue sensitivity to radiation (e.g.,

annual occupational shallow-dose

4. Basis-The following discussion a genetic condition causing an equivalent to the skin or to any provides the basis for the changes to the individual to be heterozygous as a result extremity as established in to CFR AO reporting criteria as documented in of the ataxia telangiectasia gene d).

20.1201(a)(2)(ii).

Appendix A of the policy statement.

(b) The reponing threshold for an

• It is below the threshold dose for

}

I.For AllLicensees:

unintended radiation exposure to an detrimental deterministic effects in the organ of an adult (other than bone tissue of the skin, and the bone (other A. liuman Exposure to Radiation from marrow, lens of the eye, and gonads) than the bone marrow) and muscle of Licensed Material:

resulting in the sum of the annual deep the extremities. [NCRP Commentary No.

Criterion I.A.1: Any unintended dose equivalent and committed dose 71 radiation exposure to an adult (any equivalent to any individual organ or Criterion I.A.2 has been added in individual 18 years of age or older) tissue of 2500 mSv (250 rem) or more response to the Commission's request in resulting in an annual total effective is based on the following:llowable the SRM of May 19,1994 on SECY dose eqt.ivalent (TEDE) of 250

• It is greater than the a 259, to reaffirm that a single reporting millisievert (mSv) (25 rem) or more; or regulatory limit for occupational threshold for unintended exposure is the sum of the annual deep dose exposure (500 mSv [50 rem]) for the acceptable. The potential for adverse equivalent and committed dose sum of the deep-dose equivalent and the health effects from radiation is

'l equivalent to any individual organ or committed dose equivalent to an organ independent of an individual's status as tissue, other than bone marrow, the lens or tissue (other than the lens of the eye) a radiation worker, wrong individual, or I

of the eye, or gonads of 2500 mSv (250 established by to CFR 20.1201(a)(1)(li).

member of the general public.

rem) or more; or an annual dose

• It is below the different morbidity Therefore, assigning a single dose value equivalent to bone marrow, the lens of threshold doses for deterministic effects for unintended radiation exposures is the eye, or gonads of 500 mSv (50 rem) in radiosensitive organs such as consistent with the requirements of l

or more; or an annual shallow-dose gastrointestinal track mortality, Section 208 of the Energy equivalent to the skin or extremities of pulmonary lethality, and mental Reorganization Act of1974,as j

2500 mSv (250 rem) or more.110 CFR incapacitation. [ National Council on amended. However, health effects are 1

20.1201(a)(1). 20.1201(a)(2), and 35.2)

Radiation Protection and Measurements age dependent because organs anc'.

Criterion I.A.2: Any unintended (NCRP) Commentary No. 71 l

radiation exposure to any minor (an (c) The reporting threshold for an tissues in minors, fetuses, end mbryos are more radiosensitive than in a typical individualless than 18 years of age) unintended radiation exposure to bone adult. Because of increased i

resulting in an annual TEDE of 50 mSv marrow, lens of the eye, or gonads of an radiosensitivity, a lower dose threshold (5 rem) or more, or to an embryo / fetus adult resulting in 500 mSv (50 rem) or for minors (including occupational resulting in a dose equivalent of 50 mSv more is based on the following:

exposures to minors), fetuses, and l

(5 rem) or more. [10 CFR20.1207, and

• It is equal to the allowable embryos has been included for AO 20.1301]

regulatory limit for the sum of the

?

Criterion I.A.1 and Criterion I.A.2 annual deep dose equivalent and reportig.

Critenon I.A.2 contains the reporting 1

have been revised to reflect guidance committed dose equivalent for thresholds for unintended radiation j

provided by the Commission, and to occupational exposures (0.5 Sv 150 exposures to any minor. This criterion incorporate the changes to 10 CFR Part um)) to the bone marrow or gonads; and considers both deterministic and 20, that became mandatory on January greater than the allowable regulatory stochastic effects for the purpose of 1,1994.

limit (150 mSv (15 reml) for an annual radiation protection.

Criterion I.A.1 has been revised to occupational dose equivalent to the lens (a) The reporting thresholds for an establish reporting thresholds for of the eye as established in to CFR unintended radiation exposure resulting unintended exposures to adults 20.1201(a)(2)(1).

In an annual TEDE of 50 mSv (5 rem) including TEDEs, and individual doses

• It is at the thivshold dose for initial to organs, lens of the eye, skin, and signs of temporary bone marrow or more to a minor or a dose equivalent of 50 mSv (5 rem) or more to an embryo /

extremities. The changes to this depression. INCRP Commentary No. 71 fetus are based on the potential for criterion takes into consideration

• It is at the minimum threshold dose permanent adverse health effects during deterministic and stochastic e~fec's for for known deterministic effects in the the most radiosensitive period from the the purposes of radiation protection.

point of conception to adulthood and The bases for the reporting thresholds

• TJ Mcuittian:-The Mo!.cular Basis or include the following:he allowable NN%,h]g[i,8,$$$ 3,,,g*

8 are as follows.

• It is greater than t (a) The reporting threshold for an c E. Adams, and A. Horwicht IAevier science regulatory limit (1 mSv 10.1 rem) or 10 unintended radiation exposure to an Pubhshers B.V.: copyright 1989.

percent of the limits established in 10

666 Fed:r:1 Register / Vol. 61, No. 6 / Tuesday, January 9,1996 / Notices CFR 20.1201) for annual exposures to gestation) of embryo or fetus 20.1207. The 50 mSv (5 rem) TEDE individuals other than radiation workers development. The reporting threshold reporting threshold for minors is 20 and occupational dose limits for minors (50 mSv [5 rem])is at the threshold dose percent of the threshold dose as established in 10 CFR 20.1301 and for reduced head size but no adverse established for adults in Criterion I.A.1.

20.1207, respectively.

health effects are anticipated at this Ifindividual organ reporting thresholds e It is below the minimum threshold dose. (NCRP Commentary No. 71 doses for permanent deterministic (b) Organ doses limits are not for minor occupational workers were effects in selective organs of minors provided in this criterion because the also reduced by 20 percent (Refer to because the annual TEDE reporting intent of Section 208 is addressed with Table 1, Conversion from TEDE to threshold for minors of 50 mSv (5 rem) the single TEDE limit based on the Organ Dose"), the resulting dose values equates to individual organ doses less followmg would be close in magnitude or more thm the known doses that will result in

• Individual organ doses for minors as c nservative than organ doses that I

dIterministic effects. (Refer to item (b) members of the general public would w uld equate to the 50 mSv (5 rem) below.) INCRP Commentary No. 7) not be consistent with the requirements TEDE reporting threshold. This e It is below the individual threshold of to CFR 20.1301," Dose limits for assessment is based on the " Organ Dose dose (100 mSv 110 reml) for known individual members of the general Weighting Factors" as provided in 10 permanent adverse health effects public."

CFR 20.1003 which result in the (mental retardation) during the most

. Individual occupational organ doses following data:

radiosensitive period (8 to 15 weeks of for minors are defined in to CFR TABLE 1.-CONVERSION FRou TEDE TO ORGAN DOSE Organ Rew*

Criterion Or9an Weghting dose to reporting g

factor yield 50 for rru, hold thres yg mSv*

nors Whole Body 1.0 50 mSv 50 mSv 250 mSv Gonads 025 200 mSv 100 mSv 500 mSv Breast 0.15 330 mSv 500 mSv 2500 mSv Bone marrow -

0.12 420 mSv 100 mSv 500 mSv Lungs 0.12 420 mSv 500 mSv 2500 mSv Thyroid 0.03 1670 500 mSv 2500 mSv mSv Bone surface 0.03 1670 500 mSv 2500 mSv mSv

• Organ Dose / Weighting Factor.

• • 0.2 x Cntenon I.A.1 report.ng thresholds.

(to CFR 20.1003,20.1201,20.1207, and the licensee has demonstrated containing radioactive material. (b) a 20.1301) compliance with 10 CFR 20.1301 using radiation dose rate of 50 mSv (5 rem)

• Individual organs that do not have 20.1302(b)(1) or 20.1302(b)(2)(ii).110 per hour or more on the accessible a weighting factor are still considered in CFR 20.1301, 20.1302(b)(1), or external surface of a package containing tha revised criteria by Criterion I.A.3, 20.1302(b)(2)(ii))

radioactive material and that meet the which requires reporting to Congress Criterion I.B.1 has been revised to requirements for " exclusive use" as any permanent functional damage as a reflect changes to 10 CFR Part 20 that defined in 10 CFR 71.47, or (c) release result of an exposure to an individual became mandatory on January 1,1994, of radioactive material from a package organ.110 CFR 20.1003 and 20.1301]

and to maintain the same thresholds for in amounts greater than the regulatory Criterion 1.A.3: Any radiation reporting as required by the existing AO limits in 10 CFR 71.51(a)(2). [10 CFR exposure that has resuhed in criterion. The existing reporting 71.47(a) and 71.51(I)(1)]

unintended permanent functional threshold of"500 times the regulatory Criterion I.B.2 has been revised to damage to an organ or a physiological limit of Appendix B, Table II, to CFR take into consideration additional system as determined by a physician.

Part 20" was increased to "5000 times regulatory requirements in 10 CFR Part (Generall the values specified in Table 2 of

71. This criterion has been changed to Criterion 1.A.3 has been added to Appendix B to 10 CFR Part 20" because. include limits for packages that meet the idatify for reporting' those incidents or the implied dose limit of 5 mSv (500 requirements for " exclusive use" as svznts that have resulted in an organ or mrem) used to calculate the defined in 10 CFR 71.47, a radiation physiological system morbidity or concentration' values in Table 2 of dose rate of 50 mSv (5 rem) per hour or mortality at dose levels below the Appendix B was decreased to 0.5 mSv more on the accessible external surface established AO reporting thresholds.

(50 mrem)in the revision to 10 CFR Part of a package containing radioactive B. Discharge or Dispersal of 20.

material, or the loss of confinement of Radioactive Material from its latended Criterion I.B.2: Radiation levels in radioactive material from a package in PIIce of Confinement:

excess of the design values for a amounts greater than the regulatory Criterion 1.B.1:.The release of package, or the loss of confinement of limits.

radioactive material to an unrestricted radioactive material resulting in one or The contamination requirement was t.rea in concentrations that,if averaged more of the following:(a) a radiation removed from this criterion because over a period of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, exceed 5000 dose rate of to mSv (1 rem) per hour or certain shipping casks often experience times the values specified in Table 2 of more at 1 meter (3.28 feet) from the contamination beyond licensee control Appendix B to 10 CFR Part 20, unless accessible external surface of a package after decontamination requirements had I

l.

Feder;l Regisier / Vol. 61, No. 6 / Tursday, J:nuary 9,1996 / Notices 667 been met as a result of contaminants equivalent of 50 mSv (5 rem); a ingestion of an improper transfer or j

" leaching" from the pores of the outer committed dose equivalent to any disposal of an unsealed (dispersible) surface of the shipping cask.This individual organs including the skin of source was calculated to be 2 x 10-+.

leaching effect typically occurs as a 0.5 Sv (50 rem); or in special cases, a This calculated value was based on the result of condensation on the exterior of 0.15 Sv (15 rem) dose to the lens of the review of an actual accident with the shipping cask that occurs during eye of any member of the general public, extensive uptake information (for 194 shipping. Contamination from this assuming that an exposure occurs as a cleanup workers and 77 members of the s

phenomena is not a public health and result of a source being stolen or lost.

general public). Both average fraction-safety concern and will not be reported (a) The Ai values in 10 CFR Part 71, taken-in values for transportation to Congress.

Appendix A, Table A-1, represent the accidents, and events involving lost or C. Theft. Diversion, or Loss of source strength for sealed stolen sources are comparable.

1.icensed Material, or Sabotage or (nondispersible) sources that will result Therefore, the A2 values can be used Security Breach:

in exceeding an effective dose directly to determine the source Criten,on 1.C.1:Any lost, stolen, or equivalent of 50 mSv (5 rem), from an strengths for lost and stolen unsealed abandoned sources that exceed 0.01 exterior exposure at 1 meter (3.28 feet sources that will result'in a deep dose times the A i values, as listed in 10 CFR (ft]) for 30 minutes. The proximity and equivalent, committed dose equivalent.

Part 71. Appendix A Table A-1, for duration factors of 1 meter (3.28 ft) for or shallow dose equivalent of 0.5 Sv (50 special form (sealed /non-dispersible) 30 minutes are based on the estimated rem).

sources, or the smaller of the A2 or 0.01 exposure conditions during a The smaller of the two values, the A2 times the As values, as listed in Table transportation accident involving or 0.01 times the Ai values, is used for A-1, for normal form (unsealed /

licensed materials, typically a a dispersible source because the dispersible) sources or for sources for controlled situation, material may not be dispersed and can which the form is not known. Excluded For the loss or theft of a sealed source, perform as a sealed source resulting in from reporting under this criterion are it has been conservatively calculated in external exposure. Therefore, if the those events involving sources that are a study 8 performed by Oak Ridge source strength is greater than the 0.01 lost, stolen, or abandoned under the Institute for Science and Education times the As value or greater than the A2 following conditions: sources (ORISE) that the accident weighted value, the potential exists for exceeding abandoned in accordance the average exposure proximity and an effective or committed effective dose requirernents of to CFR 39.77(c); sealed duration factors are 1 meter for 4G hours equivalent of 50 mSv (5 rem); a sources contained in labeled, rugged for the improper transfer or disposal of committed dose equivalent to any i

source housings; recovered sources with licensed material. To account for the individual organs, including the skin, of sufficient indication that doses in excess longer duration at 1 meter, from 30 0.5 Sv (50 rem); or in special cases, a of the reporting thresholds specified in minutes to 46 hours5.324074e-4 days <br />0.0128 hours <br />7.60582e-5 weeks <br />1.7503e-5 months <br /> (approximately 0.15 Sv (15 rem) dose equivalent to the AO criteria I.A.1 and I.A.2 did not occur 1:100), conservatively assuming that the lens of the eye. If the form of the source j

during the time the source was missing; entire exposure is received by one material is unknown, the smaller of the and unrecoverable sources lost under individual, the As values in 10 CFR Part two values is also used to ensure all l

such conditions that doses in excess of

71. Appendix A, Table A-1, will need potentially reportable incidents and j

the reporting thresholds specified in AO to be decreased by a factor of 100. The events are submitted to the Commission criteria I.A.1 and I.A.2 were not known multiples (0.01 x Ai values) of the As for consideration as an AO.

l to have occurred.110 CFR 20.2201(a)(i), values in to CFR Part 71, Appendix A, (c) Sources abandoned in accordance l

30.50(a),40.60(a), and 70.50(a)]

Table A-1, will determine the source with the requirement of to CFR 39.77(c) i Criterion I.C.1 has been revised to strength of a source that will result in are excluded from reporting because j

include the reporting of lost or stolen exceeding an effective dose equivalent these sources do not represent an sources that exceed 0.01 times the As of 50 mSv (5 rem) from external uncontrolled condition or potential j

values, as listed in to CFR Part 71, exposures.

effects adverse to public health and Appendix A. Table A-1,for"special (b) The A2 values in 10 CFR Part 71, safety.

form" (sealed /nondispersible) sources, Appendix A. Table A-1, represent the.

(d) Sealed (nondispersible) sources i

or the smaller of the A2 or 0.01 times the source strength for an unsealed source contained in labeled, rugged source Ae values, as listed in Table A-1, for (dispersible) that will result in a deep housings are excluded from reporting to

" normal form"(unsealed /dispersible) dose equivalent or committed dose Congress because public health and sources. Excluded from reporting under equivalent to any individual organs of safety have been shown to be reasonably this criterion are those events involving 0.5 Sv (50 rem), a shallow dose protected during the loss or theft of sources that are lost, stolen, or equivalent to the skin of 0.5 Sv (50 rem), sources that are maintained in source abandoned under the following or in special cases, a 0.15 Sv (15 rem) housings. This exclusion is based on the j

conditions: sources abandoned per the dose equivalent to the lens of the eye.

following reasons:

i requirement of to CFR 39.77(c); sealed These dose values are based on the e A sealed source as defined'in NRC sources contained in labeled, rugged assumptions that the estimated release Regulatory Guide 10.10 is radioactive i

source housings; recovered sources with fraction ranges from 10-8 to 10-2 and material contained in a protective j

sufficient indication that doses in excess the uptake fraction ranges from 10" to envelope (capsule), contained in a foil, of the reporting thresholds specified in 10-3 from inhalation and/or ingestion or plated on an inactive surface that AO criteria I.A.1 and I.A.2 did not occur (average fraction-taken-in = 10-6).

serves as a dispersion barrier, during the time the source was missing:

In the ORISE study, the average e A source housing as defined in and unrecoverable sources lost under fraction taken-in from Inhalation and American National Standard Institute such conditions that doses in excess of (ANSI) N538 is an enclosure containing the reporting thresholds specified in AO s Daniel J. Strom. Ph.D., C.H.P., Staff Scientist.

Or incorporating the source, source criteria I.A.1 and 1.A.2 were not known Operational Health Physics Group. Health holder,and a means of attenuation

$*i,".y,D'gp",Q,.r *[ns1erIDso, cener tly ucensed Devices stu A source housing is generally to have occurred. These reporting (shielding) of the radiation.

Scenarios thresholds are based on not exceeding an effective or committed effective dose

3. m4.

required to be designed and constructed

]

668 Fediral Regist:r / Vol, 61, No. 6 / Tuesday, January 9,1990'/ Notices with " rugged" characteristics so that its criteria I.A.1 and I.A.2 were not known could result in exceeding the dose limits integrity will be maintained under to have occurred is not significant from of 10 CFR Pan 100 or 5 times the dose normal conditions of use and under the standpoint of public health and limits of to CFR Part 50, Appendix A, lik:ly accident conditions and with safety.

GDC 19, could occur from a postulated saf:ty mechanisms installed to prevent Criterion I.C.2: No change to this transient or accident (e.g., loss of accid:ntal access to the source. In criterion.

emergency core cooling system, loss of addition, many generallicensed Criterion I.C.3:No change to this control rod system). (10 CFR 50.34(a)(1) housings are designed to restrict access criterion.

and 50.73(b)(2)(ii)0))

to th3 source for other than its specific Criterion I.C.4: No change to this Criterion II.B.2 has been revised to l

intInded use.

criterion.

include a reference to 5 times the dose e ANSI N538 3.4.1 recommends D. Other Events (i.e., those concerning limits in 10 CFR Part 50, Appendix A, j

sufficient shielding for shielded gauges design, analysis, construction, testing, GDC 19. This reference adds control to limit dose rates to 0.05 mSv (5 mrem) operation, use or disposal oflicensed room habitability reporting per h:ur at 30 centimeters (cm)(11.8 facilities or regulated materials):

requirements consistent with the AO l

inches), and 10 CFR 34.21(a) requires Criterion I.D.1:No change to this overexposure reporting requirements sufficient shielding for radiography criterion.

established in Criterion LA.1,"For All s;urces to limit exposure rates to 12.9 Criterion LD.2. No change to this Licensees."

x 10-scoulombs per kilogram (50 criterion.

milliroentgen) per hour at 15.2 cm (6 Criterion LD.3: No change to this HL ForFuel Cycle Licensees inchis). Assuming a conversion factor of criterion.

Criterion HL1:A required plant 1 roentgen to 1 rem, these shielding Criterion I.D.4: No change to this shutdown as a result of violating a reccmmendations will ensure that an criterion.

license condition safety limit. (10 CFR tifective dose equivalent of 50 mSv (5 H. For Commercial Nuclear Power Plant }0.36(c))

\\

rem) is not exceeded, or in special cases, Licensees Criterion III.1 has been revised to I

a 0.15 Sv (15 rem) dose equivalent to the more appropriately reference all license IIns of the eye from a 46-hour exposure A. Malfunction of Facilities, conditions rather than just TS.

i to these shielded sources at 1 meter.

Structures, or Equipment:

Criterion 111.2: No change to this

• The As values in 10 CFR Part 71 Criterion II.A.1: No change to this criterion.

Appendix A, Table A-1, assumes that criterion.

Criterion III.3: No change to this thn shielding and containment are Criterion ll.A.2: Serious degradation criterion, completely lost. This loss, however, on of fuel integrity, primary coolant l

the basis of a historical review of 1991-Prossure boundary, or primary IV. ForMedicolLicensees 1993 avents involving lost and stolen containment boundary.

The criterion for AO reporting of sources that were later found. is Criterion II.A.2 was edited to better medical misadministrations to patients unliksly for sources contained in source Paraphrase the wording in 10 CFR intended to receive a diagnostic or housings.

50.72(b)(B)(ii).

therapeutic exposure has been revised

• The source housings typically used Criterion !!.A.3: Loss of plant as follows:

i in these applications make it difficult to capability to perform essential safety A medical misadministration that:

I rccess the source.

functions such that a release of (a) results in a dose that is (1) equal

• Source housings with the proper radioactive materials, which could to or greater than 1 gray (Gy) (100 rads)

"r:dioactive labels" displayed have result in exceeding the dose limits of to to a major portion of the bone marrow, oftIn been reported by members of the CFR Part 100 or 5 times the dose limits to the lens of the eye, or to the gonads, genrral public to the proper authorities. of10 CFR Part 50, Appendix A General or(2) equal to or greater than 10 Gy Th3 ridiation symbolis easily Design Criterion (CDC) 19, could occur (1000 rads) to any other organ; ond id:ntified, relatively well known, and from a postulated transient or accident (b) represents either (1) a dose or rezdily recognized as an indicator of a (e.g., loss of emergency core cooling dosage that is at least 50 percent greater saf;ty hazard.

system, loss of control rod system). [10 than that prescribed in a written

• A review of the events reported for CFR Part 50.34(a)(1),50.72(b)(2)(iii), and directive or(2) a prescribed dose or 1991-1993 that involved the loss or 50.73(a)(2)(v)j dosage that (i)is the wrong thift of portable gauges and radiography Criterion fl.A.3 has been revised to

~ radiopharmaceutical, or (ii) is delivered dIvices contained in rugged source include a reference to 5 times the dose by the wrong route of administration, or housings verified that no known limits in to CFR Part 50, Appendix A, (iii)is delivered to the wrong treatment exposure from the loss of these types of GDC 19.This reference adds control site, or (iv) is delivered by the wrong d1 vices had occurred.

room habitability reporting treatment mode, or (v)is from a leaking

(:) Many lost or stolen sources are requirements consistent with the AO source (s). [10 CFR Part 35. International recov: red with sufficient indication that overexposure reporting requirements Council on Radiation Protection (ICRP) doses in excess of the reporting established in Criterion I.A.1,"For All 41, and NCRP Commentary No. 7]-

thresholds specified in AO criteria I.A.1 Licensees."

Medical uses of radiation result in' rnd I.A.2 did not occur during the time B. Design or Safety Analysis diagnostic or therapeutic exposures for thi source was missing. A recovered Deficiency, Personnel Error, or the purpose of diagnosing or treating a sourca,without any indication of Procedural or Administrative disease, alleviating pain, and/or exceeding the dose thresholds specified Inadequacy:

minimizing the spread of disease. With in AO criteria I.A.1 or I.A.2 is not Criterion II.B.1:No change to this this in mind, the AO reporting criterion significant from the standpoint of public criterion.

has been revised to provide a simpler health and safety, Criterion II.B.2: Personnel error or method for evaluating medical (f) Any unrecoverable source lost procedural deficiencies that result in misadministrations, and to assure that under such conditions (e.g., plane crash, loss of plant capability to perform only those events determined to be fire, etc.) that doses in excess of the essential safety functions such that a significant from the standpoint of public l

reporting thresholds specified in AO release of radioactive materials, which health and safety are reported. The l

Federal Register / Vol. 61, No. 6 / Tuesday, January 9,1996 / Notices 669 threshold doses that were selected are

.may be seen from a single exposure.

For the Nuclear Regulatory Commission.

sufficiently below the thresholds for (NCRP Commentary No. 7]

John C. Hoyle, deterministic effects recognizing the (b) The reporting threshold of10 Gy Secretaryofthe Commission.

normal treatment practice of collimation (1000 rads) selected for all organs other (FR Doc.96-283 Filed 1-6-96; 8:45 ami and fractionation of doses, where one than bone marrow, lens of the eye, and

. co,,,

would expect to see permanent organ gonads,is based on the following:

and tissue damage for most

• It is below the threshold doses at radiosensitive organs in a typical adult, which one would expect to see

[ Docket Nos. 50-237 and 50-249]

and provide a margin of error to identify permanent organ or tissue damage from the potential for harm.

normaltreatment practices for most Commonwealth Edison Company; Doses used for diagnostic purposes radiosensitive organs in adults. INCRP Dresden Nuclear Power Station, Units are relatively small and result in limited Commentary No. 7]

2 and 3 Ervironmental Assessment risk of adverse health effects. However.

• It provides a margin of safety for and Finding of No Significant impact the risk, albeit small, that exists for errors in establi,shed threshold doses for The U.S. Nuclear Regulatory selected diagnostic procedures has been most radiosensitive organs in adults.

considered during the selection of the

• It is at the estimated threshold dose Commission (the Commission)is reporting thresholds for the revised for some clinically detrimental considering issuance of an exemption from certain 29uirements ofi regulations to Facility Operatm.tsg 1.icens critenon determmistic effects from Doses dised for therapeutic purposes conventionally fractionated therapeutic in treating cancer customarily approach irradiation that can result in permanent Nos. DPR-19 and DPR-25, issued to or exceed the tolerance of normal tissue. adverse health effects in 1 to 5 percent Commonwealth Edison Company Therefore, because therapeutic radiation of the patients treated. The permanent (Comed. the licensee), for operation of doses are intended to kill cells, harmful effects seen at this threshold dose the Dresden Nuclear Power Station, side-effects might be expected from the include the absence of development and Units 2 and 3, located in Grundy radiation dose prescribed. The arrested growth in the breast and County,Ilhnois, difference between the intended and cartilage of children, respectively.

Environmental Assessment most misadministered doses has little INCRP Commentary No. 7]

added effect on long-term risk such as These values arehased on the Identification of the Proposed Action cancer. The demonstrated benefits from minhnal normal tissue tolerance dose, The proposed action is in accordance the use of byproduct materials in which is defined as the dose to which with the licensee's application dated medical applications and the long-term a given population of patients is November 20,1995, for an exemption and/or short-term consequences as a exposed, under a standard set of from certain requirements of 10 CFR result of a medical misadministration, treatment conditions, resulting in no 73.55 " Requirements for Physical were considered in developing the more than a 5-percent severe Protection of1.icensed Activitiesin revised criterion.

complication rate within 5 years after Nuclear Power Reactors Against The criterion for medicallicensees treatment. These threshold doses apply Radiological Sabotage." The requested has been revised to consider dose limits to conditions of irradiation relevant to exemption would allow the that are applicable to teletherapy, radiotherapy, that is, doses of implementation of a hand geometry

- brachytherapy, gamma stereotactic conventionally fractionated "x" or -

biometric system of site access control radiosurgery, radiopharmaceutical gamma radiation that must be delivered in conjunction with photograph therapy, and sodium iodide and to tissue to cause a serious deterministic identification badges and would allow diagnostic misadministrations. A effect. In addition, these thresholds the badges to be taken off site.

medical misadministration (as defined allow for a higher dose to be delivered by 10 CFR 35.2) involving the wrong differentially to the tumor. (ICRP 41 The Needfor the Proposed Action individual will be considered for and NCRP Commentary No. 7]

Pursuant to 10 CFR 73.55(a), the reporting as an AO under the revised

y. Guidelinesfor "OtherEvents of licensee is required to establish and, criteria for unintended exposure Interest" maintam an onsite physical protection system and secun,ty)orgamt.ation.

(criteria I.A.1 and I.A.2) because it involves an individual who did not give The Commission may determine that in 10 CFR 73.55(d," Access prior consent to being exposed, and who events other than AOs may be ofinterest Requirements," it specifies in part that is not expected to receive any benefit to Congress and the public and therefore "The licensee shall control all points.of should be included m,an Appendix to personnel and vehicle access into a from an exposure to radiation. However, 0

'Other Events of an administration to the wrong Interest, report as,delines for 'Other protected area."In 10 CFR 73.55(d)(5),

individual must meet the requirements

. The gui it specifies in part that "A numbered for a medical misadministration as Events ofInterest have been revised to picture badge identification system shall specified in 10 CFR 35.2 before being include events that may be perceived by be used for allindividuals who are orting as an AO.

the public to be of health and safety authorized access to protected areas considered for re$d dose of 1 Gy (100 (a) The thresho sigmficance and involve substantial without escort." It further indicates that 8

rads) for bone marrow, lens of the eye, regulatory response, but do not an individual not employed by the ottierwise meet the AO criteria. An licensee (e.g., contractors) may be i

or gonads is based on the following:

e It is below the threshold (1.5 Gy example is an event where upon final authorized access to protected areas (150 reds]) for bone marrow mortality evaluation by an NRC incident without an escort provided the with minimum medical care. lNCRP Investigation Team, or an Agreement individual," receives a picture badge Commentary No. 7]

State equivalent response, a upon entrance into the protected area e 11is equal to the thieshold where determination is made that such event which must be retumed upon exit from cataracts begin to form. [NCRP does not meet the criteria for an the protected area."

Commentary No. 7]

abnormal occurrence.

Currently, unescorted access for both

• It is below the initial threshold (3 pared at Rockville, Maryland, this 3rd day employee and contractor personnel into l

Gy (300 rads]) where permanent sterility of January 1996.

the Dresden Station, Units 2 and 3, is

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[7590-01-P]

Nuclear Regulatory Commission Abnormal Occurrence Reports:

Implementation of Section 208 Energy Reorganization Act of 1974; i

Final Policy Statement Agency:

Nuclear Regulatory Commission.

Action:

Final policy statement.

1 Sununary:

This final policy statement presents the revised criteria the j

Commission will use in submitting the annual abnormal occurrence (AO) reports to Congress and the public in a timely manner as stated in Section 208 of the i

Energy Reorganization Act of 1974, as amended. The A0 policy statement has i

been revised to provide more specific criteria for determining those incidents and events that the Commission considers significant from the standpoint of j

public health and safety for reporting to Congress, and to make" the A0 policy j

consistent with recent changes to NRC regulations..The revised A0 criteria j

contain more discrete reporting thresholds making them easier to use and ensuring more consistent application of the intended A0 reporting policy set forth by the Commission.

Effective Date: (Date of publication.)

i

2 Addresses: The proposed policy statement published in the Federal Reaister (January 9, 1996; 61 FR 661), and the comments received may be examined at the NRC Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC.

1 For Further Information

Contact:

Harriet Karagiannis, Office for Analysis and Evaluation of Operational Data, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone: (301) 415-6377, internet: hxk@nrc. gov.

Supplementary Information:

I.

Background.

II. Summary of Public Comments and NRC's Response.

III. Summary of Agreement State Comments and NRC's Response.

IV. The Commission Policy.

I.

Background.,

Section 208 of the Energy Reorganization Act of 1974 (Public Law 93-438, 42 U.S.C. 5848), as amended, required the Commission to submit to Congress each quarter a report listing for that period any A0s at or associated with any facility which is licensed or otherwise regulated pursuant to the Atomic Energy Act of 1954, as amended, or pursuant to this Act.

In a letter to the Senate Subcommittee on Oversight of Government Management, dated October 1, 1993, the NRC recommended to Congress a cFange in the A0 report publication frequency from quarterly to yearly. As a result, Senate 790, " Reports l

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Elimination Act," Public Law 104-66, was signed by President Clinton on-December 21, 1995, changing the A0 report' to a yearly publication.

For the purposes of Section 208 of the Energy Reorganization Act of 1974, as amended, an A0 is an unscheduled incident or event which the Comission has determined to be significant from the standpoint of public health and safety. Each such report shall contain:

f.

(1)

The date and place of each occurrence; (2)

The nature and probable consequence of each occurrence; 4

(3)

The cause or causes of each; and (4)

Any action taken to prevent recurrence.

)

The Commission also shall provide as wide dissemination to the public of the information specified in clauses.(1) and (2) of this section as 4

reasonably possible within 15 days of its receiving information of each A0 and shall provide as wide dissemination to the public as reasonably possible the information specified in clauses (3) and (4) as soon as such information becomes available.

In July 1975,-in the exercise of the authority conferred upon the Commission by Congress to determine which unscheduled incidents or events are I

significant from the standpoint of public health and safety and are reportable to Congress as A0s, the Commission developed interim criteria for. evaluating licensee incidents or events. On the basis of-these interim criteria and as required by Section 208 of the Energy Reorganization Act of 1974, as amended,

i i

i the Comission began issuing quarterly reports to Congress on A0s. These reports,' " Report to Congress on Abnormal 0ccurrences," have been issued in i

NUREG 75/090 and NUREG-0090-1 through 5 for the period from January 1975 through September 1976. On the basis of its experience in the preparation and issuance of A0 reports,-the Comission issued a general statement of. policy l

that described the manner in which it would, as part of the routine conduct of f

its business, carry out its responsibilities under Section 208 of the Energy l

Reorganization Act of 1974, as amended, for identifying A0s and making the j

requisite information concerning each occurrence available to Congress and the public in a. timely manner. This general statement of policy was published in.

the Federal Register on February 24, 1977 (42 FR 10950) and provided criteria l

and examples of types of events that the Commission would use in determining j

I whether a particular event is reportable to Congress as an A0. The Comission has since refined this statement of policy on a number of occasions to reflect i

changes in regulation and policy. On the basis of these criteria, and as i

required by Section 208 of the Energy Reorganization Act of 1974, as amended,.

j the Comission has issued quarterly reports to Congress on A0s.since March l

1977. These reports, " Report to Congress on Abnormal Occurrences," have been issued in NUREG-0090-6 through 10 and NUREG-0090, Volumes 1 through 18.

f i

i Based on its experience in the preparation and issuance of A0 reports, i

a the Comission has-decided that its responsibilities under Section 208 of the Energy Reorganization Act of 1974, as amended, can be carried out more l

' Copies of NUREGS may be purchased from the Superintendent of Documents, U.S.

I Government Printing Office, (P.O. BOX 37082), Washington, DC 20402 9328. Copies are also j

available from the National Technical Information Service, 5285 Port Royal Road, Springfrid, VA 22161. A copy is available for inspectii,.i and/or copying for a fee in the NRC Public Document Room,

~ 2120 L Street, NW (Lower Level), Washington, DC. 20037 i

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5 appropriately if the existing A0 criteria are revised to reflect changes in the Commission's policy and changes to the regulations.

The NRC staff proposed to the Commission the final revision of the A0 criteria in 1995. The Commission approved publication in the Federal Register of the A0 criteria (January 9,1996, 61 FR 661), for a 90-day public comment period. The NRC staff evaluated public comments and developed the final A0 policy statement. The Commission is issuing this final general statement of policy that describes the manner in which the Commission will, as part of the routine conduct of its business, carry out its responsibilities under Section 208 of the Energy Reorganization Act of 1974, as amended, for identifying A0s and making the requisite information concerning each occurrence available to Congress and the public in a timely manner.

Included in this policy statement are criteria that the Commission will use in determining whether a particular event is a reportable A0 within the meaning of Section 208 of the Energy Reorganization Act of 1974, as amended.

It is expected that as additional experience is gained, changes in the criteria may be required.

Abnormal Occurrence Reporting The general statement of policy has been developed to comply with the legislative intent of Section 208 of the Energy Reorganization Act of 1974, as amended, to keep Congress and the public informed of unscheduled incidents or events which the Commission considers significant from the standpoint of public health and safety. The policy reflects a range of health and safety concerns and is applicable to incidents and events involving a single

1 6

l occupational worker as well as those having an overall impact on the general

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'public.

The policy statement contains criteria that include the reporting thresholds for determining those incidents and events that are reportable by NRC for the purposes of Section 208 of the Energy Reorganization Act of 1974, as amended. The Commission has established the reporting thresholds at a level that will ensure that all events that should be considered for reporting to Congress will be identified. At the same time, the thresholds are generally above the normal level of reporting to NRC to exclude those events that involve some variance from regulatory limits, but are not significant from the standpoint of public health and safety.

Licensee Reports j

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.This final general statement of policy will not change the reporting

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a requirements _ imposed on NRC licensees by Commission regulations, license conditions, or technical specifications (TS). NRC licensees will continue to submit required reports on a wide spectrum of events, including events such as instrument malfunctions and deviations from normal operating procedures that are not significant from the standpoint of the public health and safety, but do provide data-useful to the Commission in monitoring operating trends of licensed facilities and in comparing the actual performance of these

facilities with the potential performance for which the facilities were designed and/or licensed.

Information pertaining to all events reported to the NRC will continue to be made available and placed in the public document

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7 rooms for public perusal.

In addition, the NRC publishes annual reports on events (NUREG-1272 series).

Information can also be obtained by writing to the U.S. Nuclear Regulatory Commission, Public Document Room, 2120 L Street, NW. (Lower Level) Washington,-DC 20555-0001.

In addition', the Commission will l

continue to issue news announcements on events that seem to be newsworthy

[

whether or nnt they are reported as A0s.

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II. Summary of Public Comments and the NRC's Response.

The NRC decided to revise the A0 criteria to reflect changes in NRC regulations and policy.

Before arriving to the revised A0 criteria, the NRC staff evaluated several A0 approaches and consulted with experts in the reactor and nuclear material areas, including the Advisory Comittee on the Medical.Uses of Isotopes (ACMUI), and held workshops with Agreement States te obtain their coments. This effort was to ensure that only events that have the potential for significant health and safety consequences are reported to Congress. After an evaluation several of the early written comments provided by the States were incorporated in SECY-94-275, " Revised Abnormal Occurrence Criteria" that provided the Comission a draft of the revised A0 criteria as requested in an SRM of May 19, 1994. An FRN (January 9, 1996; 61 FR 661) on

'" Abnormal Occurrence Reports:

Implementation of Section 208 Energy Reorganization Act of 1974; Proposed Policy Statement" was published for a 90-day public coment period, that included.the proposed A0' criteria. No additional coments were received from Agreement States or ACMUI on the proposed A0 policy statement as published in the FRN.

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The NRC received five letters of comment on the revised A0 policy statement published in the FRN from the following organizations: Virginia Power; the Clean Water Fund of North Carolina; the American College of Nuclear Physicians, California Chapter; the Government Relations Office of the American College of Nuclear Physicians / Society of Nuclear Medicine; and the Nuclear Energy Institute. These comments may be examined at the U.S. Nuclear i

Regulatory Ccmmission, Public Document Room, 212C L Street, NW. (Lower Level)

Washington, DC 20555-0001.

Each letter contained more than one comment, and j

i these comments are categorized into three groups: 1) modify and/or discontinue i

the A0 reporting process; 2) revise the dose threshold for reporting A0 events to Congress on unintended exposures to an adult and a minor or an embryo / fetus; and 3) reevaluate the A0 criteria applicable to medical licensees.

Public comments on the proposed policy statement and NRC's response are presented below followed by a section on the summary of Agreement State comments and NRC's response.

A.

Modify and/or Discontinue the A0 Reporting Process.

4 Comment: Because people who receive the quarterly A0 reports do not even read them, and the few that do believe the reports have little true value, the NRC should request legislation to discontinue the A0 reporting process.

Response: The value of the A0 report to Congress was recently examined in the legislation reducing the publication frequency of the report from quarterly to annually as recommended by the NRC in a letter of October 1, 1993, to the Senate Subcommittee on Oversight of Government Management. As a result,

1 9

Senate 790, " Reports Elimination and Sunset Act," Public Law 104-66, was signed by the President on December 21, 1995, changing-the A0 report to a yearly publication. Because the report was not eliminated in.the " Federal 4

Reports Elimination and Sunset Act," the NRC concludes that the A0 report remains valuable to Congress.

Comment: Discontinue the ar9endix of the A0 report on "Other Events of Interest" because (a) there is no legal justification for the development of this appendix; (b) the NRC does not have a fair mechanism for ascertaining public perception; and (c) events may be perceived as A0s and give the appearanca of safety significance when no such finding was assigned to them.

Response: Based on NRC's experience, some events have attracted w W Congressional and public interest.

Examples are events that resulted in l

petitions to the Commission by public interest groups, events that may have resulted in power reductions or shutdowns for safety-related reasons, and

[

events involving widespread media coverage.

Some of these events have also resulted in significant regulatory effort, such as an NRC Incident Investigation Team response. Although these events are not required by law to be listed in A0 reports, the Commission, as a matter of discretionary policy,

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i directed the NRC staff to incluae them to keep Congress and the public fully i

informed.

The NRC has not devehped specific criteria for the appendix of the A0 report on "Otheer Events of Interest." This allows discretion on the part of q

i the NRC in the selection of the events to ensure exclusion of unimportant 4

10 events. To avoid confusion, the "Other Events of Interest" listing will have a full description of the basis for inclusion of each event in the report and a clear indication that these events are not A0s.

B.

Revise the Dose Threshold for Reporting A0 Events to Congress on Unintended Exposures to an Adult e d a Minor or an Embryo / Fetus.

Coment:

a.

Because the revised nintended A0 dose threshold values for the whole body and any individual organ or tissue except the lens of the eye are generally consistent with the " Planned special exposures" (PSEs) of 10 CFR Part 20 (five times the annual regulatory limits), for consistency the dose l

threshold for the lens of the eye should be revised to 750 millisievert (mSv)

(75 rem), instead of the proposed A0 threshold of 500 mSv (50 ram).

b.

10 CFR 20.1201(a)(1)(ii) specifies the annual occupational limit for the sum of deep-dose equivalent and the committed-dose equivalent to any individua~i organ or tissue except the lens'of the eye. Thus, the bone marrow and the gonads should be in the category of any individual organ or tissue j

except the lens of the eye, to be consistent with 10 CFR Part 20, using the revised A0 dose threshold for other organs of 2500 mSv (250 rem).

l Response: The NRC Jid not intend to be consistent with the dose thresholds as listed in 10 CFR Part 20, " Planned special exposures," which impose doses five times-the annual regulatory limits during the individual's lifetime. Based on NRC's experience, unlike a PSE, an A0 unintended exposure event is based on radiation consequences from that single event and not the radiation y

h i

i 11 consequences over the individual's. lifetime. The NRC agrees, however, that the A0 dose threshold to the lens of the eye, the bone marrow, and the gonads i

should be increased. To be consistent with the A0 threshold used for medical misadministrations, the threshold to the lens of the eye is raised to 1 Sv (100 rem) instead of the proposed 500 mSv (50 r '. The 1 Sv (100 rem) dose threshold is still below the dose for known deterministic effects in the lens

]

of the eye such as cataracts. [t!CRP Commentary No.7) i Also, the dose threshold for the bone marrow and gonads will be revised to 1 Sv (100 rem) instead of the 2500 mSv (250 rem) recommended in the comment. The revised dose is still at the threshold for temporary bone marrow depression but below the dose threshold for permanent sterility from a single i

dose to the gonads or serious consequences due to bone marrow depression.

For

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A0 purposes, the bone marrow and the gonads are separated from the rest of the j

organs (unlike 10 CFR Part 20), due to the deterministic effects to these i

organs at the revised A0 dose thresholds.

Comment: The annual total effective dose equivalent (TEDE) for A0 reporting for members of the public should be educed to less than 4.50 mSv (0.450 rem) instead of the proposed TEDE of 25u mSv (25 rem).

Response: According to the National Council on Radiation Protection and Measurements, the estimated average effective dose equivalent rate to a person in the United States from natural radiation and man-made sources is

12 approximately 360 mrem per year.2 This dose value is about the same as the l

commenter's suggested dose threshold for reporting A0s involving members of the public to Congress. Reporting to Congress each exposure of a member of the public due to NRC-licensed activities at the level of the average dose received annually from natural and man-made sources of radiation in the United States is inappropriate. The NRC selected the revised A0 dose on the basis of the potential for radiation adverse heal +h effects to an individual, l

independent of the individual's status as a radiation worker in an occupational environment or as a member of the public. This threshold is below the level of dose for which the potential for morbidity is considered significant for individuals with an increased organ and tissue sensitivity to radiation.

Comment: The annual TEDE to any minor or embryo / fetus should be reduced to less than 3.50 mSv (0.350 rem) instead of the proposed TEDE of 50 mSv (5 rem).

Response: The NRC understands the sensitivity of an unintended exposure to a minor or an embryo / fetus and recognizes that the radiation health effects are age dependent because organs and tissues in minors, fetuses, and embryos are more radiosensitive than a typical adult. Therefore, a dose threshold of 50 mSv'(5 rem) was established for any minor or embryo / fetus, which is lower than l

the adult A0 threshold of 250 mSv (25 rem).

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In addition, the commenter's suggested threshold of 3.50 mSv (0.350 rem) is at or below the average dose that a person (including minors) in the United States receives annually from natural radiation and man-made sources as stated in the response to an earlier comment. The threshold established by NRC is A

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• lonizing Radiation Exposure of the Population of the United States, NCRP Report No. 93, National Council on Radiation Protection and Measurements, September 1987.

13 below the' minimum threshold doses for permanent deterministic effects in selective organs for a minor or an embryo / fetus, i

i Comment: The criteria related to a nursing infant, fetus, or embryo as a result of an exposure to a nursing mother or pregnant woman should be deleted j

from the criteria until the proposed rule addressing these exposures is j

resol'ved through the advice of-the Advisory Committee on Medical Uses of

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I Isotopes (ACMUI) and a separate public comment period.

Response: The NRC-recognizes the lack of a specific regulation to:dddress exposures as-a result of an unintended administration of radioactive material to a patient that is pregnant or nursing. Based on NRC's experience, some of

-these events have the potential for significant health and safety consequences to a minor or an embryo / fetus and should be reported to Congress.

C.

Reevaluate the A0 Criteria' Applicable to Medical Licensees.

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' Comment: The proposed medical A0 criteria are worse than the current criteria because they will continue to inappropriately designate non-significant events

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as A0s.

.Rerponse: The revised medical A0 criteria should result in fewer A0s than have been reported previously to Congress. These revisions were made in i

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response to NRC staff recognition of the previous low dose thresholds that resulted.in reporting events that did not have significant radiation consequences.

In addition, the new criteria also respond to previous public 1

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criticism and to changes in other NRC regulations relating to radiation protection.

Coment: The A0 criteria applicable to medical licensees should be excluded from the A0 policy statement because the NRC does not have sufficient competence in medicine and pharmacy to determine public safety significance of medical events.

Response: Because the NRC regulates byproduct material including the medical use of this material, criteria for medical events have been developed and must be included in the A0 policy statement to comply with Section 208 of. the Energy Reorganization Act of 1974, as amended. The revised criteria are based on widely accepted standards for radiation protection and were reviewed by the ACMUI. Therefore, the NRC believes that events exceeding the criteria are sufficiently-important to inform Congress and the public.

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Coment: Congress may obtain information on significant medical events from tl.e FDA instead of the NRC.

Response: Section 208 of the Energy Reorganization Act of 1974, as amended, requires reporting to Congress licensee events that the NRC determines to be significant from the standpoint of public health and safety. An enactment of law would be necessary to change this' requirement and appoint another agency such as the FDA to undertake the A0 responsibility.

i Coment: ACMUI should review the medical A0 criteria.

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15 Response: The revised criteria were presented to ACMUI and comments received were incorporated before publishing them in the Federal Register (January 9, 1996; 61 FR 661).

Because only minor changes have been made to the criteria since ACMUI's review, the Commission docs not believe that it is necessary for ACMUI to further examine the criteria.

Coment: Add a third condition to the medical A0 criteria to read: "and (c) is a radiation exposure that has resulted in unintended permar.ent functional damage to an organ or a physiological system as cetermined 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 potential 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 16 patients were determined to be A0s and were reported to Congress. As a result, the Commission'is revising the A0 criteria dose thresholds for medical events to exclude insignificant events.

III. Summary of Agreement' State Comments and NRC's Response.

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'Seven Agreement States submitted comments to the NRC before development of the Commission paper, SECY-94-275, " Revised Abnormal Occurrence Criteria."

These States were Arkansas, Georgia, Kentucky, New York, Texas, Tennessee, and Washington. After evaluating the comments, several were incorporated in the Commission paper. A summary of the Agreement State comments applicable to the 1

A0 criteria listed in the proposed policy statement as published in the FRN, and NRC's_ response are presented below:

j A.

Modify, Reevaluate and/or Discontinue Items of the A0 Reporting Process.

I i

i Comment: Four States commented on the specific guidelines of a prior revision of the proposed appendix of the A0 report on "Other Events of. Interest" or wanted "Other Events of Interest" deleted.

Response

It should be noted that the section on "Other Events of Interest" contained in this final A0 policy statement has been revised since the time that Agreement States provided comments, and therefore comments on the specific guidelines of the section do not apply.

In reference to the elimination of "Other Events of Interest," see NRC's response to the second public comment under Category A.

4 37 Comment: - One State suggested that the A0 criteria should apply to exposures from non-Atomic Energy Act (AEA) material.

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Response: Section 208 of the Energy Reorganization Act of 1974, as amended, provides that the-Commission shall submit to Congress each year a report listing for that period any A0s at or associated with any facility which is licensed or-otherwise regulated pursuant to the Atomic Energy Act of 1954,' as amended, or pursuant to this Act. Therefore, the A0 criteria will not apply to' events involving the use of non-AEA material since this material is not regulated by the NRC.

Comoent: One State commented that the A0 policy statement imposes additional

. requirements on licensees.

Response: The A0 policy statement will not change the reporting requirements imposed on NRC licensees by Commission regulations, license conditions, or-technical specifications. The:NRC licensees will continue to submit _ required event reports. The A0 criteria will only be used by the NRC during internal review and evaluation for reporting significant events to Congress.

Comment: One State commented that criterion I.A.3 is arbitrary.

Response: The NRC disagrees. Because individual sensitivity to radiation varies, the basis of. criterion I.A.3 is to capture those events that have resulted in unintended, permanent functional damage to an organ or a physiological system at thresholds below those listed in the A0 criteria.

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18 However, the NRC believes that.there will be very few of these events.

In most cases permanent organ and physiological damage will occur only at doses

-l above the proposed A0 thresholds.

Comment: 'One State-commented that criterion,I.D.3 is arbitrary.

Response: The NRC disagrees.

Based on NRC's experience, certain reported events,'a'1though they did not result in significant radiation consequences, had the potential for' adverse impacts oc public health and safety because of a j

serious failure of the licensees's radiation. protection program and lack of-management control and oversight and.should be reported to Congress.

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j Comment: Two States' commented that " wrong patient" should be considered in-the misadministration A0 criteria instead of the general A0 criteria i

applicable to all licensees.

Response

In the SRM of May 19, 1994, on SECY-93-259, the NRC staff was directed by the Commission to establish a. single-dose threshold value to identify doses to an occupational worker, a member of the public, and a wrong

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individual (wrong patient),8 which are significant from a health and safety standpoint. The basis was that, for the purpose of reporting to Congress, the potential for physical harm to an. individual resulting from the unintended

. exposure is the same whether the exposure was received in. an occupational i

• In the Federal Register notice dated September '20,1995 (60 FR 48623), *10 CFR Parts 20

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. and 35, Medical Administration of Radiation and Radioactive Material," the term " Wrong patient" was replaced by the term

• Wrong individual.*

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l 19 setting, as a patient who was not intended to receive a prescribed dose, or as l

a member of the public.

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Comment: Three States suggested providing credentials for a " physician" as listed in criterion I.A.3.

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 lists a group of physicians that the NRC staff may obtain as consultants in case of an incident. The NRC staff has reviewed the credentials of these physicians and has determined that they have the expertise in specialized areas using.

byproduct material for the evaluation of radiation consequences. The Inspection Manual is available in the NRC public document room, 2120 L Street, NW. (Lower Level), Washington, DC 20555-0001.

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l 20 B.

Be Consistent with the Regulations and Reconsider the Criterion for a Minor, or an Embryo / Fetus.

Coment: One State commented that the A0 criteria should be consistent with 10 CFR Part 20.

Response: To the extent practical, the NRC has been consistent with 10 CFR Part 20, and at the same time has established thresholds to include only events that have the potential to result in deterministic effects due to i

unintended exposures.

Coment: Two States expressed concern about developing an A0 dose threshold,

for events regarding a minor, or an embryo / fetus since the NRC has-not yet developed a regulation establishing a dose threshold for reporting these events to the NRC.

Response: See response to fourth public comment under Category B.

IV. The Commission Policy - General Statement of Policy on Implementation of Section 208 of the Energy Reorganization Act of 1974, as Amended.

1.

Apolicability.

Implementation of Section 208 of the Energy Reorganization Act of 1974, as amended, Abnormal Occurrence Reports, involves the conduct of Commission business and does not impose requirements on licensees. Reports will cover certain unscheduled incidents or events related

t 21 l

i t'o'the manufacture, construction,.-or operation of a facility or conduct of an l

i activity subject to the requirements of Parts 20, 30 through 36, 39, 40, 50, 61, 70, 71, or 72 of Chapter I, Title 10, Code of federal Regulations (10 CFR).

-i Through an exchange of information, Agreement States provide information' to the NRC on incidents and events involving applicable nuclear materials that have occurred in their States. _Those. events reported by Agreement States that reach the threshold for reporting as an A0 are also published in the " Report to Congress on Abnormal Occurrences."

2.

Definition of terms. As used in this policy statement:

(a) An " abnormal occ-rence" means an unscheduled incident or event at a facility or' associated r'to an activity that is licensed or otherwise regulated. pursuant to tt.e Atomic Energy Act of 1954, as amended,-or the

.l Energy Reorganization Act of 1974, as amended, that the Commission determines i

to be significant from the standpoint of public health and safety; and (b) an " unintended radiation exposure" includes any occupational exposure, exposure to the general public, or exposure as 'a result of a medical misadministration (as defined in 6 35.2) involving the wrong individual that exceeds the reporting values established in the regulations.

All other reported medical misadministrations will be considered for reporting as an A0 under the criteria for medical licensees.

In addition,

22 i

unintended radiation exposures include any exposure to a nursing infant, fetus, or embryo as a. result of an_ exposure (other than an occupational i

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

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

An incident or egent will be considered an A0 if it involves a major i

reduction in the degree of protection of the public health or safety. This l

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 j

following:

(1)

Moderate exposure to, or release of, radioactive material licensed by or otherwise regulated by the Commission; I

(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.

I 23 4.

Commission' dissemination of A0 information.

(a) The Commission will provide as wide a dissemination of information to the public as reasonably possible. A Federal Register notice will be i

issued cn each A0 with copies distributed to the NRC Public Document Room and all. local public ' document rooms. When additional information is anticipated, the notice will state that the information can be obtained at the NRC Public Document Room and in all local public document rooms.

(b)-

Each year,- the Commission will submit a report to Congress listing

{

i for that period any A0s at or associated with any facility or activity which 1s licensed or otherwise regulated pursuant to the Atomic Energy _ Act of 1954, as amended, or the Energy Reorganization Act of 1974,~as amended. This report will contain the date, place,' nature,s and probable consequence of each A0, the cause or causes of each A0, and any action taken to prevent recurrence.

Appendix A - Abnormal Occurrence Criteria I

Criteria by types of events used to determine which incidents or events will be considered for reporting. as A0s are as follows:

i

24-l <

I. For All Licensees.

i'

.A. Human Exposure'to Radiation from Licensed Material.

l. Any unintended radiation exposure to an adult (any individual 18 years i

of' age or older) resulting in an annual total effective dose equivalent (TEDE) of 250 millisievert (mSv) (25 rem) or more; or an annual sum of the deep dose equivalent (external dose) and committed dose equivalent L

i (intake of radioactive material) to any individual organ or tissue other

.than the; lens of the eye, bone marrow and the gonads, of 2500 mSv (250 rem) or. more; or. an annual dose equivalent to the lens of the eye, iof:

1 Sv:(100 rem)1or more; or an annual sum of.the deep dose equivalent and

. committed dose equivalent to the bone marrow, and the gonads, of.1 Sv.

.(100 rem).or more; or. an annual shallow-dose equivalent to the skin or extremities of 2500 mSv (250 rem) or more.

2.LAny unintended radiation exposure to any minor (an individual less.than 18 years: of age) resulting in an annual TEDE of 50 mSv (5 rem) or more, or to an embryo / fetus resulting in a dose equivalent of 50 mSv (5 rem) or more.

1 3.'Any radiation exposure that has resulted in unintended permanent 4

functional damage to an organ or a physiological system as determined by a physician.

25 B. Discharge or Dispersal of Radioactive Material from its Intended Place of Confinement.

1. The release of radioactive material to an unrestricted area in concentrations which, if averaged over a period of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, exceed 5000 times the values specified in Table 2 of appendix B to M CFR Part 20, unless the licensee has demonstrated compliance with 9 20.1301 using 6 i 20.1302 (b) (1) or 20.1302 (b) (2) (ii).

l 1

2. Radiation levels in excess of the design values for a package, or the loss of confinement of radioactive material resulting in one or more of i

the following: (a) a radiation dose rate of 10 mSv (1 rem) per hour or more at I meter (3.28 feet) from the accessible external surface of a package containing radioactive material; (b) a radiation dose rate of 50 mSv (5 rem) per hour or more on the accessible external surface of a package containing radioactive material and that meet the requirements for " exclusive use" as defined in 10 CFR 71.47; or (c) release of radioactive material from a package in amounts greater than the regulatory limits in 10 CFR 71.51(a)(2).

4 m-

26 i

C. Theft, Diversion, or Loss of Licensed Material, or Sabotage or Security Breach.'

1. Any_ lost, stolen, or abandoned sources that exceed 0.01 times the A -

3 values, as listed in 10 CFR Part 71, appendix A, Table A-1, for special

' form (sealed /nondispersible) sources, or the smaller of the A2 or 0.01 times the A, values, as listed in Table A-1, for normal form (unsealed /

dispersible) sources or for sources for which the form is not known.

Excluded from reporting under this criterion are those evants involving sources that are lost, stolen, or abandoned under the following conditions: sources abandoned in accordance with the requirements of 10 CFR 39.77(c); sealed sources contained in labeled, rugged source housings; recovered sources with sufficient indication that doses in i

excess of the reporting thresholds specified in A0 criteria I.A.1 and i

1.A.2 did not' occur during the time the source was missing; and unrecoverable sources lost under such conditions that doses in excess of the reporting thresholds specified in A0 criteria I.A.1 and I.A.2 were not known to have occurred.

2. A substantiated case of actual or attempted theft or diversion of licensed material or sabotage of a facility.

' inforrnation pertaining to certain incidents may be either classified or under consideration for

' classification because of national security irnplications. Classified information will be withheld when formally reporting these incidents in accordance with Section 208 of the Energy Reorganization Act of

' 1974, as amended. Any classified details regarding these incidents would be available to the Congress, upon request, under appropriate security arrangements.

1 o-27

3. Any. substantiated loss of special nuclear material or any substantiated-j inventory discrepancy that is' judged to be significant relative to normally expected performance, and that is judged to be caused by theft or diversion or by substantial breakdown of the accountability system.

4. Any substantial breakdown of physical security or material control (i.e., access control containment or accountability systems) that j

significantly weakened the protection against theft, diversion, or sabotage.

D. Other Events (i.e., those concerning design, analysis, construction, testing, operation, use, or disposal of licensed facilities.or regulated materials).

1. An accidental criticality [10 CFR 70.52(a)].

2. A major deficiency in design, construction, control, or operation having i

i significant safety implications requiring immediate remedial action.

3. A serious deficiency in management or procedural controls in major areas.

i

4. Series of events (where individual events are not of major importance),

recurring incidents, and incidents with implications for similar facilities (generic incidents) that create a major safety concern.

j i

u

28 II. For Commercial Nuclear Power Plant Licensees.

A. Malfunction of Facility, Structures, or Equipment.

1. Exceeding a safety limit of license technical specification (TS)

[l 50.36(c)].

2. Serious degradation of fuel integrity, primary coolant pressure boundary, or primary containment boundary.

l

3. Loss of plant. capability to perform assential safety functions so that.a release of-radioactive materials, which could result in exceeding the dose limits of 10 CFR Part 100 or 5 times the dose limits of 10 CFR Part 50, appendix A, General Design Criterion (GDC) 19, could occur from a postulated transient or accident (e.g., loss of emergency core cooling system, loss of control rod system).

B. Design or-Safety Analysis Deficiency, Personnel Error, or Procedural or Administrative Inadequacy.

1. Discovery of a major condition not specifically considered in the safety analysis report (SAR) or TS that requires immediate remedial action.

2. Personnel error or procedural. deficiencies that result in ~1oss of plant capability to perform essential safety functions so that a release of radioactive materials, which could result in exceeding the dose limits

1 i

29 of 10 CFR Part 100 or 5 times the dose limits of 10 CFR 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 system).

III. For.' Fuel Cycle Licensees.

1 i

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

2 A

i

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 perform its designated function.

4

-IV. For Medical Licensees.

A medical misadministration that:

(a) results in a dosa that i: (1) equal to or greater than 1 gray (Gy)

(100 rads) to a major portion of the bone marrow, to the lens of the eye, or to the gonads, or (2) equal to or greater than 10 Gy (1000. rads) to any other organ; and

l 30 t

(b)

-represents either (1) a dose or dosage that is at least 50 percent i

greater than that prescribed 'in a written directive or (2) a l

prescribed dose or dosage that (i) is the wrong radiopharmaceutical,5 or (ii)'is delivet J by the wrong route of l

administration, or (iii) is delivered to the wrong treatment site, or (iv) is delivered by the wrong treatment mode, or (v) is from a leaking source (s).

5 5

V. Guidelines for "Other Events of Interest."

The Commission may determine that events other than A0s may be of interest to Congress and the public and be included in an appendix to I

the A0 report as "Other Events of Interest." Guidelines for events to be included in the A0 report for this purpose are items that may possibly be perceived by the public to be of health or safety significance. Such items would not involve a major reduction in the level of protection provided for public health or safety; therefore, they would not be reported as abnormal occurrences. An example is an event where upon final evaluation by an NRC Incident Investigation Team, or an Agreement State equivalent response, a determination is made that the event does not meet the criteria for an abnormal occurrence.

Dated at Rockville, Maryland, this day of 1996.

l' For the Nuclear Regalatory Commission.

l l

John C. Hoyle, Secretary of the Commission.

• The wrong radiopharmaceutical as used in the AO c..terion for medical misadministrations refers to any radiopharmaceutical other than the one listed in the written directive or in the clinical procedures manual.