Abnormal Occurrence Reports: Implementation of Section 208 Energy Reorganization Act of 1974; Final Policy Statement

NUCLEAR REGULATORY COMMISSION

Abnormal Occurrence Reports: Implementation of Section 208 Energy

Reorganization Act of 1974; Final Policy Statement

AGENCY: Nuclear Regulatory Commission.

ACTION: Final policy statement.

-----------------------------------------------------------------------

SUMMARY: This final policy statement presents the revised criteria the

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 Energy Reorganization Act of 1974, as amended. The

AO policy statement has been revised to provide more specific criteria

for determining those incidents and events that the Commission

considers significant from the standpoint of public health and safety

for reporting to Congress, and to make the AO policy consistent with

recent changes to NRC regulations. The revised AO criteria contain more

discrete reporting thresholds making them easier to use and ensuring

more consistent application of the intended AO reporting policy set

forth by the Commission.

EFFECTIVE DATE: December 19, 1996.

ADDRESSES: The proposed policy statement published in the Federal

Register (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.

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:

[email protected].

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 (Pub. L. 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 AOs 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 change in the AO report publication frequency from quarterly

to yearly. As a result, Senate 790, ``Reports Elimination Act,'' Public

Law 104-66, was signed by President Clinton on December 21, 1995,

changing the AO report to a yearly publication.

For the purposes of Section 208 of the Energy Reorganization Act of

1974, as amended, an AO is an unscheduled incident or event which the

Commission has determined to be

[[Page 67073]]

significant from the standpoint of public health and safety. Each such

report shall contain:

(1) The date and place of each occurrence;

(2) The nature and probable consequence of each occurrence;

(3) The cause or causes of each; and

(4) Any action taken to prevent 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 reasonably possible within 15 days of its receiving

information of each AO 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 significant from the standpoint of public health and safety

and are reportable to Congress as AOs, 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, the Commission began issuing

quarterly reports to Congress on AOs. These reports,1 ``Report to

Congress on Abnormal Occurrences,'' have been issued in 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 AO reports, the Commission issued a general statement of

policy that described the manner in which it would, 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 AOs and making the 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 and examples

of types of events that the Commission would use in determining whether

a particular event is reportable to Congress as an AO. The Commission

has since refined this statement of policy on a number of occasions to

reflect changes in regulation and policy. On the basis of these

criteria, and as required by Section 208 of the Energy Reorganization

Act of 1974, as amended, the Commission has issued quarterly reports to

Congress on AOs since March 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.

---------------------------------------------------------------------------

\1\ Copies of NUREGS may be purchased from the Superintendent of

Documents, U.S. Government Printing Office, (P.O. BOX 37082),

Washington, DC 20402-9328. Copies are also available from the

National Technical Information Service, 5285 Port Royal Road,

Springfield, VA 22161. A copy is available for inspection and/or

copying for a fee in the NRC Public Document Room, 2120 L Street, NW

(Lower Level), Washington, DC. 20037

---------------------------------------------------------------------------

Based on its experience in the preparation and issuance of AO

reports, the Commission has decided that its responsibilities under

Section 208 of the Energy Reorganization Act of 1974, as amended, can

be carried out more appropriately if the existing AO 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

AO criteria in 1995. The Commission approved publication in the Federal

Register of the AO criteria (January 9, 1996, 61 FR 661), for a 90-day

public comment period. The NRC staff evaluated public comments and

developed the final AO 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 AOs 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 AO 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 occupational worker as well as

those having an overall impact on the general 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

This final general statement of policy will not change the

reporting 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 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 continue to issue news

announcements on events that seem to be newsworthy whether or not they

are reported as AOs.

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

The NRC decided to revise the AO criteria to reflect changes in NRC

regulations and policy. Before arriving to the revised AO criteria, the

NRC staff evaluated several AO approaches and consulted with experts in

the reactor and nuclear material areas, including the Advisory

Committee on the Medical Uses of Isotopes (ACMUI), and held workshops

with Agreement States to obtain their comments. This effort was to

ensure that only events that have the potential for significant health

and

[[Page 67074]]

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 Commission a draft of the revised AO criteria as

requested in an SRM of May 19, 1994. A Federal Register Notice (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 comment

period, that included the proposed AO criteria. No additional comments

were received from Agreement States or ACMUI on the proposed AO policy

statement as published in the FRN.

The NRC received five letters of comment on the revised AO 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 Regulatory Commission, Public

Document Room, 2120 L Street, NW. (Lower Level) Washington, DC 20555-

0001. Each letter contained more than one comment, and these comments

are categorized into three groups: (1) modify and/or discontinue the AO

reporting process; (2) revise the dose threshold for reporting AO

events to Congress on unintended exposures to an adult and a minor or

an embryo/fetus; and (3) reevaluate the AO 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 AO Reporting Process

Comment: Because people who receive the quarterly AO 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 AO

reporting process.

Response: The value of the AO 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, Senate 790, ``Reports Elimination

and Sunset Act,'' Public Law 104-66, was signed by the President on

December 21, 1995, changing the AO report to a yearly publication.

Because the report was not eliminated in the ``Federal Reports

Elimination and Sunset Act,'' the NRC concludes that the AO report

remains valuable to Congress.

Comment: Discontinue the appendix of the AO 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 AOs and give the appearance of safety significance when no

such finding was assigned to them.

Response: Based on NRC's experience, some events have attracted

wide Congressional and public interest. Examples are events that

resulted in 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 AO reports, the

Commission, as a matter of discretionary policy, directed the NRC staff

to include them to keep Congress and the public fully informed.

The NRC has not developed specific criteria for the appendix of the

AO report on ``Other Events of Interest.'' This allows discretion on

the part of the NRC in the selection of the events to ensure exclusion

of unimportant 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 AOs.

B. Revise the Dose Threshold for Reporting AO Events to Congress on

Unintended Exposures to an Adult and a Minor or an Embryo/Fetus

Comment: a. Because the revised unintended AO 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 threshold for the lens of the eye

should be revised to 750 millisievert (mSv) (75 rem), instead of the

proposed AO threshold of 500 mSv (50 rem).

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 individual 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 except the lens of the eye, to be consistent with 10

CFR Part 20, using the revised AO dose threshold for other organs of

2500 mSv (250 rem).

Response: The NRC did 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 AO

unintended exposure event is based on radiation consequences from that

single event and not the radiation consequences over the individual's

lifetime. The NRC agrees, however, that the AO dose threshold to the

lens of the eye, the bone marrow, and the gonads should be increased.

To be consistent with the AO 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 rem). 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. [NCRP Commentary

No.7]

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 dose to the gonads or serious

consequences due to bone marrow depression. For AO purposes, the bone

marrow and the gonads are separated from the rest of the organs (unlike

10 CFR Part 20), due to the deterministic effects to these organs at

the revised AO dose thresholds.

Comment: The annual total effective dose equivalent (TEDE) for AO

reporting for members of the public should be reduced to less than 4.50

mSv (0.450 rem) instead of the proposed TEDE of 250 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 approximately 360 mrem per year.2 This dose value is

about the same as the commenter's suggested dose threshold for

reporting AOs involving members of the public to Congress. Reporting to

[[Page 67075]]

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 AO dose on the basis of the

potential for radiation adverse health effects to an individual,

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.

---------------------------------------------------------------------------

\2\ Ionizing Radiation Exposure of the Population of the United

States, NCRP Report No. 93, National Council on Radiation Protection

and Measurements, September 1987.

---------------------------------------------------------------------------

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 the adult AO

threshold of 250 mSv (25 rem).

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 below the minimum threshold doses for

permanent deterministic effects in selective organs for a minor or an

embryo/fetus.

Comment: The criteria related to a nursing child, fetus, or embryo

as a result of an exposure to a nursing mother or pregnant woman should

be deleted from the criteria until the proposed rule addressing these

exposures is resolved through the advice of the Advisory Committee on

Medical Uses of Isotopes (ACMUI) and a separate public comment period.

Response: The NRC recognizes the lack of a specific regulation to

address 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 AO Criteria Applicable to Medical Licensees

Comment: The proposed medical AO criteria are worse than the

current criteria because they will continue to inappropriately

designate non-significant events as AOs.

Response: The revised medical AO criteria should result in fewer

AOs than have been reported previously to Congress. These revisions

were made in 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 criticism and to changes in other NRC

regulations relating to radiation protection.

Comment: The AO criteria applicable to medical licensees should be

excluded from the AO 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 AO 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.

Comment: Congress may obtain information on significant medical

events from the 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

AO responsibility.

Comment: ACMUI should review the medical AO criteria.

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). Only minor changes have been

made to the criteria since ACMUI's review.

Comment: Add a third condition to the medical AO criteria to read:

``and (c) is a radiation exposure that has resulted in unintended

permanent functional damage to an organ or a physiological system as

determined by a physician'' to eliminate reporting events to Congress

that do not have any medical significance.

Response: The NRC believes that the dose thresholds of the revised

criteria have sufficient margin included to limit the reporting of

insignificant events. In addition, the NRC considers it important to

report events that have the 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.

Comment: Insignificant medical events have been included in the

past AO reports to Congress.

Response: The NRC understands the commenters' concerns with the

implementation of the medical AO 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 patients were determined to be AOs and were

reported to Congress. As a result, the Commission is revising the AO

criteria dose thresholds for medical events to exclude insignificant

events.

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

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 AO criteria listed in

the proposed policy statement as published in the FRN, and NRC's

response are presented below:

A. Modify, Reevaluate and/or Discontinue Items of the AO Reporting

Process

Comment: Four States commented on the specific guidelines of a

prior revision of the proposed appendix of the AO 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 AO 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

[[Page 67076]]

second public comment under Category A.

Comment: One State suggested that the AO criteria should apply to

exposures from non-Atomic Energy Act (AEA) material.

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 AOs 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 AO criteria will not apply to events involving the use

of non-AEA material since this material is not regulated by the NRC.

Comment: One State commented that the AO policy statement imposes

additional requirements on licensees.

Response: The AO 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 AO 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 AO criteria. 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 above the proposed AO thresholds.

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

Response: The NRC disagrees. Based on NRC's experience, certain

reported events, although they did not result in significant radiation

consequences, had the potential for adverse impacts on public health

and safety because of a serious failure of the licensees's radiation

protection program and lack of management control and oversight and

should be reported to Congress.

Comment: Two States commented that ``wrong patient'' should be

considered in the misadministration AO criteria instead of the general

AO criteria 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 individual (wrong patient),3 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 setting, as a

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

member of the public.

---------------------------------------------------------------------------

\3\ In the Federal Register 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.''

---------------------------------------------------------------------------

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 provides guidance on the use of NRC

consultants in case of an incident. In addition, the NRC staff has

developed NRC Management Directive 8.10, ``NRC Medical Event Assessment

Program'' to ensure timely and comprehensive review of medical events.

IMC 1360 and Management Directive 8.10 are available in the NRC public

document room, 2120 L Street, NW. (Lower Level), Washington, DC 20555-

0001.

B. Be Consistent With the Regulations and Reconsider the Criterion for

a Minor, or an Embryo/Fetus

Comment: One State commented that the AO 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 unintended exposures.

Comment: Two States expressed concern about developing an AO 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. Applicability. 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 to the manufacture, construction, or

operation of a facility or conduct of an 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).

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 AO are also published in the ``Report to Congress on Abnormal

Occurrences.''

2. Definition of terms. As used in this policy statement:

(a) An ``abnormal occurrence'' means an unscheduled incident or

event at a facility or associated with an activity that is licensed or

otherwise regulated, pursuant to the Atomic Energy Act of 1954, as

amended, or the Energy Reorganization Act of 1974, as amended, that the

Commission determines 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 Sec. 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 AO under the criteria for medical licensees. In

addition, unintended radiation exposures include any exposure to a

nursing child, fetus, or embryo as a result of an exposure (other than

an occupational exposure to an undeclared pregnant woman) to a nursing

mother or pregnant woman above specified values.

3. Abnormal occurrence general statement of policy. The Commission

[[Page 67077]]

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 AO within the purview of

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

An incident or event will be considered an AO if it involves a

major reduction in the degree of protection of the public health or

safety. This type of incident or event would have a moderate or more

severe impact on the public health or safety and could include, but

need not be limited to the following:

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

licensed by or otherwise regulated by the Commission;

(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 AOs are set out in appendix

A of this policy statement.

4. Commission dissemination of potential AO and AO information.

(a) The Commission will provide as wide a dissemination of

information to the public as reasonably possible. Information on

potential AOs (events that may meet the AO criteria) will be sent to

the NRC Public Document Room and all local public document rooms as

soon as possible after the staff determines that the incident is a

potential AO. A Federal Register notice will be issued on each AO

report 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 for that period any AOs at or associated with any facility or

activity which is 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,

and probable consequence of each AO, the cause or causes of each AO,

and any action taken to prevent recurrence.

Appendix A--Abnormal Occurrence Criteria

Criteria by types of events used to determine which incidents or

events will be considered for reporting as AOs are as follows:

I. For All Licensees

A. Human Exposure to Radiation From Licensed Material

1. Any unintended radiation exposure to an adult (any individual 18

years 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 (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, of 1 Sv (100 rem) or 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. Any 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.

3. Any radiation exposure that has resulted in unintended permanent

functional damage to an organ or a physiological system as determined

by a physician.

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 hours, exceed

5000 times the values specified in Table 2 of appendix B to 10 CFR Part

20, unless the licensee has demonstrated compliance with Sec. 20.1301

using Sec. 20.1302 (b) (1) or 20.1302 (b) (2) (ii).

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 the following: (a) A radiation dose rate of 10 mSv (1 rem) per

hour or more at 1 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).

C. Theft, Diversion, or Loss of Licensed Material, or Sabotage or

Security Breach 4

---------------------------------------------------------------------------

\4\ Information pertaining to certain incidents may be either

classified or under consideration for classification because of

national security implications. 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. Any lost, stolen, or abandoned sources that exceed 0.01 times

the A1 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 A1 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 events 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 excess of the reporting thresholds specified

in A0 criteria I.A.1 and I.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.

3. Any substantiated loss of special nuclear material or any

substantiated 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 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

[[Page 67078]]

having significant safety implications requiring immediate remedial

action.

3. A serious deficiency in management or procedural controls in

major areas.

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.

II. For Commercial Nuclear Power Plant Licensees

A. Malfunction of Facility, Structures, or Equipment

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

[Sec. 50.36(c)].

2. Serious degradation of fuel integrity, primary coolant pressure

boundary, or primary containment boundary.

3. Loss of plant capability to perform essential 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 loss

of plant capability to perform essential 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, 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. A required plant shutdown as a result of violating a license

condition or other safety limit.

2. A major condition not specifically considered in the license

that requires immediate remedial action.

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

system to perform its designated function.

IV. For Medical Licensees

A medical misadministration that:

(a) Results in a dose that is (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

(b) Represents either (1) a dose or dosage that is at least 50

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

prescribed dose or dosage that (i) is the wrong

radiopharmaceutical,5 or (ii) is delivered by the wrong route of

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\ The wrong radiopharmaceutical as used in the AO criterion

for medical misadministrations refers to any radiopharmaceutical

other than the one listed in the written directive or in the

clinical procedures manual.

---------------------------------------------------------------------------

V. Guidelines for ``Other Events of Interest''

The Commission may determine that events other than AOs may be of

interest to Congress and the public and be included in an appendix to

the AO report as ``Other Events of Interest.'' Guidelines for events to

be included in the AO 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 13th day of December, 1996.

For the Nuclear Regulatory Commission.

John C. Hoyle,

Secretary of the Commission.

[FR Doc. 96-32210 Filed 12-18-96; 8:45 am]

BILLING CODE 7590-01-P