[Federal Register Volume 90, Number 153 (Tuesday, August 12, 2025)]
[Notices]
[Pages 38828-38831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-15293]
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
[NRC-2023-0075]
Abnormal Occurrence Reporting
AGENCY: Nuclear Regulatory Commission.
ACTION: Policy statement; issuance.
-----------------------------------------------------------------------
SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing a
limited revision to its policy statement on reporting abnormal
occurrences (AOs) to Congress. The revised policy statement provides
more specific language to the medical event criteria to better identify
those incidents and events that the Commission considers significant
from the standpoint of public health or safety. The revised AO criteria
contain additional language to add clarity, helping to delineate
abnormal occurrence events from nonreportable events which may have
been reviewed under the previous criteria.
DATES: The policy statement is effective on August 12, 2025.
ADDRESSES: Please refer to Docket ID NRC-2023-0075 when contacting the
NRC about the availability of information for this action. You may
obtain publicly available information related to this action by any of
the following methods:
Federal Rulemaking website: Go to https://www.regulations.gov and search for Docket ID NRC-2023-0075. Address
questions about NRC dockets to Helen Chang; telephone: 301-415-3228;
email: [email protected]. For technical questions, contact the
individual listed in the FOR FURTHER INFORMATION CONTACT section of
this document.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may obtain publicly available documents online in the
ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``Begin Web-based ADAMS
Search.'' For problems with ADAMS, please contact the NRC's Public
Document Room (PDR) reference staff at 1-800-397-4209, at 301-415-4737,
or by email to [email protected]. The ADAMS accession number for
each document referenced (if it is available in ADAMS) is provided the
first time that it is mentioned in the SUPPLEMENTARY INFORMATION
section.
NRC's PDR: The PDR, where you may examine and order copies
of publicly available documents, is open by appointment. To make an
appointment to visit the PDR, please send an email to
[email protected] or call 1-800-397-4209 or 301-415-4737, between 8
a.m. and 4 p.m. eastern time, Monday through Friday, except Federal
holidays.
FOR FURTHER INFORMATION CONTACT: Rigel Flora, Office of Nuclear
Regulatory Research, U.S. Nuclear Regulatory Commission, Washington DC
20555-
[[Page 38829]]
0001; telephone: 301-415-3890; email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 208 of the Energy Reorganization Act of 1974, as amended
(Public Law 93-438), defines an AO as an unscheduled incident or event
that the NRC determines to be significant from the standpoint of public
health or safety. As required by Section 208, the discussion for each
event includes the date and place, the nature and probable
consequences, the cause or causes, and the action taken to prevent
recurrence. The Commission must also widely disseminate the AO report
to the public within 15 days of publishing the AO report to Congress.
The Federal Reports Elimination and Sunset Act of 1995 (Pub. L. 104-66)
requires that AOs be reported to Congress annually.
Abnormal Occurrence Reporting
The Commission developed the AO policy statement to comply with
Section 208 of the Energy Reorganization Act of 1974, as amended. The
annual AO report is developed based upon the criteria in the AO policy
statement. The AO report keeps Congress and the public informed of
unscheduled incidents or events that the Commission considers
significant from the standpoint of public health or safety. This policy
addresses a range of health or safety concerns and applies to incidents
and events involving a single individual, as well as those having an
overall impact on the general public. The AO criteria set out in the
policy use a reporting threshold so that only those events considered
significant from the standpoint of public health or safety are reported
to Congress.
Licensee Reports
The changes to the general policy statement do not change the
reporting requirements for licensees in NRC or Agreement State
regulations, license conditions, or technical specifications. The
licensees will continue to submit required reports on a wide range of
events, including instrument malfunctions and deviations from normal
operating procedures that may not be significant from the standpoint of
the public health or safety but provide data useful to the NRC in
monitoring operating trends of licensed facilities and in comparing the
actual performance of these facilities with their design and/or
licensing basis.
II. Opportunity for Public Participation
The NRC is revising the AO criteria for medical events to improve
conformance with current regulatory requirements and reflect new
developments in medical radiation treatments. In developing the revised
AO criteria, the NRC staff consulted with experts in the reactor and
nuclear material areas, including the Advisory Committee on the Medical
Uses of Isotopes (ACMUI), and coordinated with Agreement States. The
NRC staff undertook this effort to ensure events that have the
potential for significant health or safety consequences are properly
identified and reported to Congress.
The NRC staff provided multiple opportunities for public
participation. Staff shared the preliminary proposed change with the
Organization of Agreement States (OAS) for comment. Several
coordination meetings were held with ACMUI providing updates on the
process and allowing opportunity for comments. Additionally, the
proposed AO criteria were published in the Federal Register (FR) on May
19, 2023 (88 FR 32144), for a 90-day public comment period. No comments
were received.
III. Coordination With NRC Agreement States
The NRC coordinated with the Agreement States throughout the
development of this final policy statement. On May 5, 2021, the NRC
provided a preliminary proposed policy statement to the Agreement
States for their review and comment. The OAS Executive Board (Board)
provided comments dated July 26, 2021. The NRC staff did not make any
changes in response to the comments.
While the Board was generally supportive of the 2021 preliminary
proposed changes, it suggested edits to the AO criteria that would be
inclusive of nuclear medicine extravasations, which are currently
excluded from medical event reporting requirements. The NRC staff
considered the Board's recommendations and concluded that revision of
the AO criteria to capture extravasations is outside the scope of the
Commission's direction to make limited changes to the medical AO
criteria in the policy statement on AO reporting. However, the NRC
staff submitted SECY-24-0067, Proposed Rule: Reporting Nuclear Medicine
Injection Extravasations as Medical Events (ADAMS Accession Package No.
ML24016A290) on August 13, 2024, to the Commission for its
consideration. The proposed rule would amend the regulations in title
10 of the Code of Federal Regulations (10 CFR) Part 35, ``Medical Use
of Byproduct Material,'' to require reporting of certain nuclear
medicine injection extravasations as medical events.
IV. Coordination With the Advisory Committee on the Medical Uses of
Isotopes
The ACMUI submitted comments on the preliminary proposed policy
statement in a final report dated June 1, 2021 (ADAMS Accession No.
ML21227A001). These comments concerned the reporting of events that the
ACMUI may not find to be significant for public health or safety. The
ACMUI recommended that criteria in Section III.C ``For Medical
Licensees'' be adjusted to remove dose-based criteria and instead focus
on radiation induced injuries, significant adverse health effects, or
death. In response to SRM-SECY-22-0009 (ADAMS Accession Package No.
ML23088A089), NRC staff retained previous Section III.C criteria (ADAMS
Accession No. ML12166A196) and did not make any changes in response to
ACMUI's recommendation. The final ACMUI comment concerned moving
reporting of embryo/fetal exposure from Section I.A ``Human Exposure to
Radiation from Licensed Material'' to Section III.C. The NRC staff did
not make any changes in response to this comment.
V. Congressional Review Act
This policy statement is not a rule as defined in the Congressional
Review Act (5 U.S.C. 801-808).
Dated: August 8, 2025.
For the Nuclear Regulatory Commission.
Carrie Safford,
Secretary of the Commission.
Attachment--Abnormal Occurrence Statement of Policy
Appendix A
Abnormal Occurrence Criteria; Abnormal Occurrence General Statement of
Policy
The U.S. Nuclear Regulatory Commission (NRC) 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 or an Agreement State is an abnormal
occurrence (AO): \1\
---------------------------------------------------------------------------
\1\ Events reported to the NRC by Agreement States that reach
the threshold for reporting as AOs will be reported as such by the
Commission.
---------------------------------------------------------------------------
An incident or event is considered an AO if it involves a major
reduction in the protection of public health or safety. The incident
or event has a moderate or severe impact on 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 or Agreement
State;
[[Page 38830]]
(2) Major degradation of essential safety-related equipment;
(3) Major deficiencies in design, construction, use of, or
management controls for, facilities or radioactive material licensed
by or otherwise regulated by the Commission or Agreement State; or
(4) Substantiated case of actual loss, theft, or diversion of
risk-significant radioactive material licensed by or otherwise
regulated by the Commission or Agreement State.
Abnormal Occurrence Criteria
The following presents the criteria, by types of events, used to
determine which events will be considered for reporting as AOs.
I. All Licensees 2
---------------------------------------------------------------------------
\2\ Medical patients and human research subjects are excluded
from consideration under these criteria, and these criteria do not
apply to medical events defined in Sec. 35.3045 of Title 10 of the
Code of Federal Regulations (10 CFR), ``Report and notification of a
medical event,'' which are considered in AO Criteria III.C.
---------------------------------------------------------------------------
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:
a. An annual total effective dose equivalent (TEDE) of 250
millisieverts (mSv) (25 rem) or more;
b. An annual sum of the deep dose equivalent (external dose) and
committed dose equivalent (intake of radioactive material) to any
individual organ other than the lens of the eye, the bone marrow,
and the gonads of 2,500 mSv (250 rem) or more;
c. An annual dose equivalent to the lens of the eye of 1 Sievert
(Sv) (100 rem) or more;
d. An annual sum of the deep dose equivalent and committed dose
equivalent to the bone marrow of 1 Sv (100 rem) or more;
e. A committed dose equivalent to the gonads of 2,500 mSv (250
rem) or more; or
f. An annual shallow-dose equivalent to the skin or extremities
of 2,500 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 an independent physician \3\ deemed qualified by the
NRC or Agreement State.
---------------------------------------------------------------------------
\3\ ``Independent physician'' is defined as a physician not on
the licensee's staff and who was not involved in the care of the
patient involved.
---------------------------------------------------------------------------
B. Discharge or Dispersal of Radioactive Material From Its Intended
Place of Confinement
The release of radioactive material to an unrestricted area in
concentrations that, if averaged over a period of 24 hours, exceed
5,000 times the values specified in Table 2 of Appendix B, ``Annual
Limits on Intake (ALIs) and Derived Air Concentrations (DACs) of
Radionuclides for Occupational Exposure; Effluent Concentrations;
Concentrations for Release to Sewerage,'' to 10 CFR part 20,
``Standards for protection against radiation,'' unless the licensee
has demonstrated compliance with Sec. 20.1301, ``Dose limits for
individual members of the public,'' using Sec. 20.1302(b)(1) or
Sec. 20.1302(b)(2)(ii). This criterion does not apply to
transportation events.
C. Theft, Diversion, or Loss of Licensed Material; Sabotage; or
Security Breach 4 5 6
---------------------------------------------------------------------------
\4\ Information pertaining to certain incidents may either be
classified or under consideration for classification because of
national security implications. Classified information will be
withheld when formally reporting these incidents in accordance with
Executive Order 13526, ``Classified National Security Information,''
as amended (75 FR 707; January 5, 2010), or any predecessor or
successor order to require protection against unauthorized
disclosures. Any classified details about these incidents would be
available to Congress upon request, under appropriate security
arrangements.
\5\ Information pertaining to certain incidents may be
Safeguards Information as defined in Sec. 73.2 because of safety
and security implications. The AO report would withhold specific
Safeguards Information in accordance with Section 147 of the Atomic
Energy Act of 1954, as amended. Any safeguards details regarding
these incidents would be available to Congress upon request, under
appropriate security arrangements.
\6\ Reporting lost or stolen material is based on the activity
of the source at the time the radioactive material was known to be
lost or stolen. If, by the time the AO report is due to Congress,
the radioactive material has decayed below the thresholds listed in
Appendix A to 10 CFR part 37, the report will clarify that the
radioactive material has decayed below the thresholds.
---------------------------------------------------------------------------
1. Any stolen, diverted, abandoned, or unrecovered lost
radioactive material that meets or exceeds the thresholds listed in
Appendix A, ``Category 1 and Category 2 Radioactive Materials,'' to
10 CFR part 37, ``Physical Protection of Category 1 and Category 2
Quantities of Radioactive Material.'' Excluded from reporting under
this criterion are those events involving sources that are lost or
abandoned under the following conditions: sources that have been
lost and for which a reasonable attempt at recovery has been made
without success, or irretrievable well logging sources as defined in
Sec. 39.2, ``Definitions.'' These sources are only excluded if
there is reasonable assurance that the doses from these sources have
not exceeded, and will not exceed, the reporting thresholds
specified in AO Criteria I.A.1 and I.A.2 and the agency has
determined that the risk of theft or diversion is acceptably low.
2. An act that results in radiological sabotage as defined in
Sec. 37.5 and Sec. 73.2.
3. Any substantiated \7\ case of actual theft, diversion, or
loss of a formula quantity of special nuclear material,\8\ or an
inventory discrepancy of a formula quantity of special nuclear
material that is judged to be caused by theft or diversion.
---------------------------------------------------------------------------
\7\ ``Substantiated'' means a situation in which there is an
indication of loss, theft, or unlawful diversion, such as an
allegation of diversion, report of lost or stolen material, or other
indication of loss of material control or accountability that cannot
be refuted following an investigation, and requires further action
on the part of the agency or other proper authorities.
\8\ ``Formula quantity of special nuclear material'' is defined
in Sec. 70.4, ``Definitions.''
---------------------------------------------------------------------------
4. Any substantial breakdown \9\ of physical security, cyber
security, or material control and accountability programs that
significantly weakens the protection against loss, theft, diversion,
or sabotage.
---------------------------------------------------------------------------
\9\ A substantial breakdown is defined as a red finding under
the Reactor Oversight Process (ROP) in the physical security
inspection program or any plant or facility determined to have
overall unacceptable performance.
---------------------------------------------------------------------------
5. Any significant unauthorized disclosures (loss, theft, and/or
deliberate disclosure) of classified information that harms national
security or of Safeguards Information that threatens public health
or safety.
D. Initiation of High-Level NRC Team Inspection 10
---------------------------------------------------------------------------
\10\ This item addresses the initiation of any incident
investigation teams, as described in NRC Management Directive (MD)
8.3, ``NRC Incident Investigation Program'' (ADAMS Accession No.
ML13175A294), or initiation of any accident review groups, as
described in MD 8.9, ``Accident Investigation'' (ADAMS Accession No.
ML13319A133).
---------------------------------------------------------------------------
II. Commercial Nuclear Power Plant Licensees
A. Malfunction of Facility, Structures, or Equipment
1. Exceeding a safety limit of a 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 that could
result in exceeding the dose limits of 10 CFR part 100, ``Reactor
site criteria,'' or five times the dose limits of General Design
Criteria (GDC) 19, ``Control Room,'' in Appendix A, ``General Design
Criteria for Nuclear Power Plants,'' to 10 CFR part 50, ``Domestic
licensing of production and utilization facilities,'' 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 or TS that requires immediate remedial
action.
2. Personnel error or procedural deficiencies that result in the
loss of plant capability to perform essential safety functions such
that a release of radioactive materials exceeding the dose limits of
10 CFR part 100 or five times the dose limits of GDC 19 in Appendix
A to 10 CFR part 50, could occur from a postulated transient or
accident (e.g., loss of emergency core cooling system, loss of
control rod drive mechanism).
C. Any operating reactor events or conditions evaluated by the
NRC ROP to be the result of or associated with licensee
[[Page 38831]]
performance issues of high safety significance.\11\
---------------------------------------------------------------------------
\11\ The NRC ROP uses four colors to describe the safety
significance of licensee performance. As defined in NRC MD 8.13,
``Reactor Oversight Process'' (ADAMS Accession No. ML17347B670),
green is used for very low safety significance, white is used for
low to moderate safety significance, yellow is used for substantial
safety significance, and red is used for high safety significance.
Reactor conditions or performance indicators evaluated to be red are
considered AOs.
---------------------------------------------------------------------------
D. Any operating reactor events or conditions evaluated by the
NRC Accident Sequence Precursor (ASP) program to have a conditional
core damage probability (CCDP) or change in core damage probability
([Delta]CDP) of greater than or equal to 1 x 10-\3\.\12\
---------------------------------------------------------------------------
\12\ Results from the NRC Accident Sequence Precursor program
are used to monitor agency performance against the agency's
strategic safety goal (e.g., ensure the safe use of radioactive
materials) and objectives (e.g., prevent and mitigate accidents and
ensure radiation safety). A precursor event with a CCDP or
[Delta]CDP of greater than or equal to 1 x 10-3 is used
as a performance indicator for the strategic safety goal by
determining that there have been no significant precursors of a
nuclear reactor accident and that there have been no more than one
significant adverse trend in industry safety performance.
---------------------------------------------------------------------------
E. Any operating reactor plants that are determined to have
overall unacceptable performance or are in a shutdown condition as a
result of significant performance problems and/or operational
event(s).\13\
---------------------------------------------------------------------------
\13\ Any plants assessed by the ROP to be in the unacceptable
performance column, as described in NRC Inspection Manual Chapter
(IMC) 0305, ``Operating Reactor Assessment Program'' (ADAMS
Accession No. ML19256A191), or under NRC IMC 0350, ``Oversight of
Reactor Facilities in a Shutdown Condition Due to Significant
Performance and/or Operational Concerns'' (ADAMS Accession No.
ML17116A273). This assessment of safety performance is based on the
number and significance of NRC inspection findings and licensee
performance indicators.
---------------------------------------------------------------------------
III. Events at Facilities Other Than Nuclear Power Plants and All
Transportation Events
A. Events Involving Design, Analysis, Construction, Testing,
Operation, Transport, Use, or Disposal
1. An accidental criticality.
2. A major deficiency in design, construction, control, or
operation having significant safety implications that require
immediate remedial action.
3. A serious safety-significant deficiency in management or
procedural controls.
4. A series of events (in which the individual events are not of
major importance), recurring incidents, or incidents with
implications for similar facilities (generic incidents) that raise a
major safety concern.
B. Fuel Cycle Facilities 14
---------------------------------------------------------------------------
\14\ Criterion III.A also applies to fuel cycle facilities.
---------------------------------------------------------------------------
1. Absence or failure of all safety controls (engineered and
human) such that conditions were present for the occurrence of a
high-consequence event involving an NRC-regulated hazard
(radiological or chemical).\15\
---------------------------------------------------------------------------
\15\ High-consequence events for facilities licensed under 10
CFR part 70, ``Domestic licensing of special nuclear material,'' are
those that could seriously harm the worker or a member of the public
in accordance with Sec. 70.61, ``Performance requirements.'' The
integrated safety analysis conducted and maintained by the licensee
or applicant of 10 CFR part 70 fuel cycle facilities identifies such
hazards and the safety controls (Sec. 70.62(c)) applied to meet the
performance requirements in accordance with Sec. 70.61(b) through
(d). Fuel cycle facilities licensed under 10 CFR part 40, ``Domestic
licensing of source material,'' or certified under 10 CFR part 76,
``Certification of gaseous diffusion plants,'' have licensing basis
documents that describe facility specific hazards, consequences, and
those controls used to prevent or mitigate the consequences of such
accidents. For these facilities, a high-consequence event would be a
release that has the potential to cause acute radiological or
chemical exposures to a worker or a member of the public similar to
that defined in Appendix A to Chapter 3, Section A.2, of NUREG-1520,
Revision 2, ``Standard Review Plan for Fuel Cycle Facilities License
Applications--Final Report,'' issued June 2015, under ``Consequence
Category 3 (High Consequences)'' (ADAMS Accession No. ML15176A258).
---------------------------------------------------------------------------
2. An NRC-ordered safety-related or security-related immediate
remedial action.
C. Events Involving the Medical Use of Radioactive Materials in
Patients or Human Research Subjects 16
---------------------------------------------------------------------------
\16\ Criteria III.A.2, III.A.3, and III.A.4 also apply to
medical licensees.
---------------------------------------------------------------------------
1. A medical event, as defined in Sec. 35.3045 or in conditions
of a license,\17\ which results in an unintended dose:
---------------------------------------------------------------------------
\17\ ``In conditions of a license'' means either the specific
35.1000 medical criterion can be written out in a license condition,
or a license condition can incorporate a commitment to use the
applicable criteria.
---------------------------------------------------------------------------
a. That is equal to or greater than 1 gray (Gy) (100 rad) to a
major portion of the bone marrow or to the lens of the eye; or equal
to or greater than 2.5 Gy (250 rad) to the gonads; or
b. To any other organ or tissue from the administration that
exceeds, by 10 Gy (1,000 rad), the intended dose or the dose that
would have resulted from delivery of the prescribed dose, prescribed
dosage, or prescribed activity; and
2. A medical event, as defined in Sec. 35.3045 or in conditions
of a license 17
a. A dose or dosage that is at least 50 percent greater than
that prescribed, or
b. A prescribed dose or dosage that:
(i) Uses the wrong radiopharmaceutical or unsealed byproduct
material; 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 or sources; or
(vi) is delivered to the wrong individual or human research
subject.
[FR Doc. 2025-15293 Filed 8-11-25; 8:45 am]
BILLING CODE 7590-01-P