[Federal Register Volume 61, Number 245 (Thursday, December 19, 1996)]
[Notices]
[Pages 67072-67078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32210]


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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