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

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URL: https://www.frixlaw.com/law-library/documents/fr%3A96-32210

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** December 19, 1996
- **Citation:** 61 FR 67072

## Text

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.

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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.
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\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
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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.
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\2\ Ionizing Radiation Exposure of the Population of the United
States, NCRP Report No. 93, National Council on Radiation Protection
and Measurements, September 1987.
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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.
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\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.''
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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 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
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\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.
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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).
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\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.
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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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A96-32210. Public record. Not legal advice.