[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Notices]
[Pages 45907-45912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21043]


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NUCLEAR REGULATORY COMMISSION

[NRC-2015-0176]


Abnormal Occurrence Reports

AGENCY: Nuclear Regulatory Commission.

ACTION: Policy revision; issuance.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing a 
revision to its policy statement on reporting abnormal occurrences 
(AOs) to Congress. The revised policy statement adds more specific 
criteria for determining those incidents and events that the Commission 
considers significant from the standpoint of public health or safety 
for reporting to Congress and the public, and makes the policy 
consistent with recent changes to NRC regulations. The revised AO 
criteria contain more discrete reporting thresholds, making them easier 
to implement and ensuring more consistent reporting.

DATES: This revision to the policy statement is effective on October 2, 
2017.

ADDRESSES: Please refer to Docket ID NRC[dash]2015[dash]0176 when 
contacting the NRC about the availability of information regarding this 
action. You may obtain publicly-available information related to this 
action using any of the following methods:
     Federal Rulemaking Web Site: Go to http://www.regulations.gov and search for Docket ID NRC[dash]2015[dash]0176. 
Address questions about NRC dockets to Carol Gallagher; telephone: 301-
415-3463; 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 http://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``ADAMS Public Documents'' and 
then 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, 301-415-4737, or by email to [email protected]. The 
ADAMS accession number for each document referenced in this document 
(if that document is available in ADAMS) is provided the first time 
that a document is referenced. For the convenience of the reader, the 
ADAMS Accession numbers are provided in a

[[Page 45908]]

table in Section VIII, ``Availability of Documents,'' of this document.
     The NRC's PDR: You may examine and purchase copies of 
public documents at the NRC's PDR, Room O1-F21, One White Flint North, 
11555 Rockville Pike, Rockville, Maryland 20852.

FOR FURTHER INFORMATION CONTACT: Tanya Palmateer Oxenberg, Office of 
Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001; telephone: 301-415-2437; email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Background
II. Opportunity for Public Participation
III. Coordination With NRC Agreement States
IV. Coordination With the Advisory Committee on the Medical Uses of 
Isotopes
V. Congressional Review Act
VI. Availability of Documents

I. Background

    Section 208, ``Abnormal Occurrence Reports,'' of the Energy 
Reorganization Act of 1974, as amended (Pub. L. 93[dash]438) (the Act), 
defines an AO as an unscheduled incident or event that the NRC 
determines to be significant from the standpoint of public health or 
safety. The Federal Reports Elimination and Sunset Act of 1995 (Pub. L. 
104[dash]66) requires that AOs be reported to Congress annually. As 
required by Section 208, the discussion for each reported 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.

Abnormal Occurrence Reporting

    The Commission has developed the AO policy statement to comply with 
Section 208 of the Energy Reorganization Act. The intent of the Act is 
to keep Congress and the public informed of unscheduled incidents or 
events that the Commission considers significant from the standpoint of 
public health or safety. The policy reflects a range of health and 
safety concerns and applies both to incidents and events involving a 
single individual and to those having an overall impact on the general 
public. The AO criteria use a high 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 policy statement do not change the reporting 
requirements for NRC licensees in Commission regulations, license 
conditions, or technical specifications. The NRC 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 public 
health or safety but that provide data useful to the Commission in 
monitoring the 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

    To develop 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 coordinated with Agreement States. The NRC staff 
undertook this effort to ensure that it was properly identifying those 
events that have the potential for significant health or safety 
consequences are reported to Congress.
    After an evaluation, the NRC staff incorporated several comments 
provided by the States and ACMUI into the draft revision in SECY-15-
0040, ``Proposed Revisions to Policy Statement on Reporting Abnormal 
Occurrence Criteria,'' dated March 19, 2015 (ADAMS Accession No. 
ML12166A091). The proposed AO policy statement that was published for 
comment included the Commission's subsequent direction in the staff 
requirements memorandum (SRM) for SECY-15-0040, dated June 30, 2015 
(ADAMS Accession No. ML15181A030). The proposed AO criteria was 
published in the Federal Register (FR) on August 17, 2015 (80 FR 
49177), for a 90[dash]day public comment period.
    The NRC received three comment letters on the proposed AO criteria 
published in the FR from the Organization of Agreement States (OAS) 
(ADAMS Accession No. ML16209A194), Washington State Department of 
Health (WDH) (ADAMS Accession No. ML16209A199), and the Commonwealth of 
Virginia Department of Health (VDH) (ADAMS Accession No. ML16209A196). 
Each letter contained multiple comments. In summary, the comments asked 
the NRC to (1) revise and/or remove the dose threshold for reporting AO 
events to Congress on unintended exposures to an adult and a minor or 
an embryo/fetus, (2) add ``medical physicist'' or revise ``independent 
physician'' in the requirement to obtain the determination of an 
independent physician, (3) remove the requirements for ``irretrievable 
well logging sources,'' (4) clarify the applicability of the 
``substantial breakdown'' provision in Criterion I.C.4 to materials 
licensees, and (5) remove or modify Criterion III.C medical events.

III. Coordination With NRC Agreement States

    The NRC coordinated with the Agreement States throughout the 
development of this final policy statement. In October 2013, the NRC 
provided a preliminary proposed policy statement to the Agreement 
States for their review and comment. The Agreement States provided 
comments on the preliminary proposed policy statement. Several comments 
resulted in revisions to the proposed AO criteria. A summary of the 
Agreement State comments and the NRC staff responses to those comments 
are available at ADAMS Accession No. ML14346A274.
    The NRC received comment letters on the proposed AO criteria, which 
was published in the FR on August 17, 2015 (80 FR 49177). The NRC 
received comments from OAS, WDH, and VDH. Each letter contained 
multiple comments. The NRC staff analyzed and categorized these 
comments according to the AO criterion to which they apply. A summary 
of the Agreement States' comments and the NRC staff responses to the 
comments are available in ADAMS under Accession No. ML16209A049. The 
staff did not make any changes in response to the comments.
    The AO criteria are designed to identify those events that could 
signal a potential public health or safety issue and evaluate events in 
a broad industrywide perspective. In response to comments regarding the 
requirement that an independent physician determine whether permanent 
functional damage occurred, the NRC staff did not agree to add 
``authorized medical physicist'' because medical physicists are neither 
qualified nor credentialed to make a medical determination that 
unintended permanent functional damage to an organ or a physiological 
system has occurred. The criterion requires a determination by an 
independent physician ``deemed qualified by the NRC or Agreement 
State,'' which takes into account all pertinent credentialing aspects 
of the individual, including specialty in the relevant field.

[[Page 45909]]

    The staff disagreed with removing or modifying requirements for 
``irretrievable well logging sources'' and Criterion III.C medical 
events. The staff disagreed with modifying the criterion regarding 
``irretrievable well logging sources'' as NRC and Agreement State 
regulations require the licensee to evaluate the potential threat to 
public health or safety from an abandoned irretrievable source. This 
evaluation and dose assessment would be used as a basis to evaluate 
these events as potential AOs for irretrievable well logging sources. 
The NRC previously added Criterion III.C for medical AO because the 
Commission considered misadministrations to be a concern. The current 
criteria are based on doses that would likely have a significant 
potential for resulting in permanent deterministic effects.
    In response to a comment that requested clarification of the 
applicability of the ``substantial breakdown'' provision in criterion 
l.C.4 to materials licensees, the staff explained that this criterion 
is principally for licensees that possess special nuclear material and 
whose activities are included in a security plan required by part 73 of 
title 10 of the Code of Federal Regulations (10 CFR). Criterion I.C.1 
is the principal criterion for security incidents involving materials 
subject to 10 CFR part 37 for NRC or Agreement State radioactive 
materials licensee events to determine if an AO has occurred.

IV. Coordination With the Advisory Committee on the Medical Uses of 
Isotopes

    The ACMUI submitted comments on the proposed AO policy statement in 
a letter dated November 6, 2015 (ADAMS Accession No. ML15356A087). 
These comments concerned the reporting of incidents and events related 
to medical use that the ACMUI found may not be significant for public 
health or safety. The NRC prepared a response to the ACMUI 
recommendations (ADAMS Accession No. ML16209A061). Most of ACMUI's 
comments indicated agreement with the proposed revisions to the policy 
statement. However, ACMUI had three comments recommending changes to 
the AO criteria. The staff disagreed with two comments and partially 
agreed with one comment. The staff agreed to add ``and human research 
subjects'' to footnote 2 to Criterion 1, but it disagreed with 
excluding events reported under Sec.  35.3047 from Criterion I.A.2. The 
staff also disagreed with adding Sec.  35.3047 to the footnote text 
because this would establish two different thresholds for reporting an 
AO involving exposure to an embryo/fetus: one for an embryo/fetus 
unintentionally exposed due to a medical administration to a pregnant 
individual and one for an embryo/fetus exposed from all other sources 
of licensed material.

V. Congressional Review Act

    This policy statement is not a rule as defined in the Congressional 
Review Act (5 U.S.C. 801-808).

VI. Availability of Documents

    The documents identified in the following table are available as 
indicated.

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                                                  ADAMS Accession No./FR
          Date                   Document                citation
------------------------------------------------------------------------
03/19/2015.............  SECY-15-0040, Proposed   ML12166A091
                          Revisions to Policy
                          Statement on Reporting
                          Abnormal Occurrence
                          Criteria.
06/30/2015.............  Staff Requirements--     ML15181A030
                          SECY-15-0040--Proposed
                          Revisions to Policy
                          Statement on Reporting
                          Abnormal Occurrence
                          Criteria.
08/17/2015.............  Proposed revision to     80 FR 49177
                          policy statement
                          issued for a 90 day
                          public comment period..
11/16/2015.............  OAS letter to NRC, RE:   ML16209A194
                          Opportunity to Comment
                          on Proposed Revision
                          to Abnormal Occurrence
                          Policy Statement.
11/17/2015.............  State of Washington      ML16209A199
                          Comment for Docket ID
                          NRC[dash]2015-0176
                          Abnormal Occurrence
                          Criteria Revision.
11/12/2015.............  Virginia Comments on     ML16209A196
                          Abnormal Occurrence
                          (AO) Reporting
                          Revision.
03/19/2015.............  Summary of Major         ML14346A274
                          Agreement State
                          Comments.
                         and Staff Response.....
07/08/2016.............  Summary of Organization  ML16209A049
                          of Agreement State
                          (OAS), State of
                          Washington, and
                          Commonwealth of
                          Virginia Comments and
                          Staff Response.
11/06/2015.............  Final ACMUI Comments on  ML15356A087
                          Proposed Revision of
                          the NRC Policy
                          Statement on Reporting
                          Abnormal Occurrences
                          to Congress.
10/09/2015.............  Meeting Summary, ACMUI   ML15294A461
                          Meeting,.
                         October 8-9, 2015......
08/08/2016.............  Staff's Response to the  ML16209A061
                          Advisory Committee on
                          the Medical Uses of
                          Isotopes' November 6,
                          2015, Recommendations
                          to Final Comments on
                          Proposed Revision of
                          the NRC Policy
                          Statement on Reporting
                          Abnormal Occurrences
                          to Congress.
06/24/2014.............  Management Directive     ML13175A294
                          8.3, ``NRC Incident
                          Investigation
                          Program''.
04/11/2014.............  Management Directive     ML13319A133
                          8.9, ``Accident
                          Investigation''.
10/03/2010.............  Management Directive     ML101400045
                          8.13, ``Reactor
                          Oversight Process,''
                          DT-10-14.
12/23/2015.............  Inspection Manual        ML15317A147
                          Chapter (IMC) 0305,
                          ``Operating Reactor
                          Assessment Program''.
12/15/2006.............  IMC 350, ``Oversight of  ML063400076
                          Reactor Facilities in
                          a Shutdown Condition
                          Due to Significant
                          Performance and/or
                          Operational Concerns''.
06/30/2015.............  NUREG-1520 Rev. 2,       ML15176A258
                          ``Standard Review Plan
                          for Fuel Cycle
                          Facilities License
                          Applications,'' Final
                          Report.
------------------------------------------------------------------------


[[Page 45910]]

    The final policy statement is attached.

    Dated at Rockville, Maryland, this 26th day of September 2017.

    For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.

Statement of Policy

General Statement of Policy on the Implementation of Section 208 of the 
Energy Reorganization Act of 1974, as Amended

Applicability

    Implementation of Section 208, ``Abnormal Occurrence Reports,'' of 
the Energy Reorganization Act of 1974, as amended, involves the conduct 
of Commission business and does not impose requirements on licensees or 
certified facilities. The reports cover certain unscheduled incidents 
or events related to the manufacture, construction, or operation of a 
facility or the conduct of an activity subject to the requirements of 
parts 20, 30 through 37, 39, 40, 50, 61, 70, 71, 72, or 76 of title 10 
of the Code of Federal Regulations (10 CFR).
    Agreement States provide information to the U.S. Nuclear Regulatory 
Commission (NRC) on incidents and events involving nuclear materials in 
those States. Agreement States are those States that have entered into 
formal agreements with the NRC, pursuant to Section 274 of the Atomic 
Energy Act of 1954, as amended (AEA) (Pub. L. 83-703), to regulate 
certain quantities of AEA material at facilities located within their 
borders. Events reported by Agreement States that reach the threshold 
for reporting as abnormal occurrences (AOs) are also published in the 
``Report to Congress on Abnormal Occurrences.''

Abnormal Occurrence General Statement of Policy

    The Commission will apply the following policy in determining 
whether an incident or event at a facility or involving an activity 
that is licensed or otherwise regulated by the Commission or an 
Agreement State is an AO.\1\
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    \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.
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    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 
States;
    (2) Major degradation of essential safety-related equipment;
    (3) Major deficiencies in design, construction, or use of, or 
management controls for, facilities or radioactive material licensed by 
or otherwise regulated by the Commission or Agreement States; or
    (4) Substantiated case of actual loss, theft, or diversion of 
risk[dash]significant radioactive material licensed by or otherwise 
regulated by the Commission or Agreement States.
    Appendix A to this policy statement sets forth the criteria for 
determining whether an incident or event is as an AO.

Commission Dissemination of Abnormal Occurrence Information

    The Commission widely disseminates AO reports to the public. The 
Commission submits an annual report to Congress on AOs at or associated 
with any facility or activity that is licensed or otherwise regulated 
by the NRC. This report provides the date, place, nature, and probable 
consequences of each AO; the cause or causes of each AO; and any action 
taken by the licensee to prevent recurrence.

Appendix A: Abnormal Occurrence Criteria

    An incident or event is considered an abnormal occurrence (AO) 
if it involves a major reduction in the degree of protection of 
public health or safety. This type of 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 
States;
    (2) Major degradation of essential safety-related equipment;
    (3) Major deficiencies in design, construction, or use of, or 
management controls for facilities or radioactive material licensed 
by or otherwise regulated by the Commission or Agreement States; 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 States.

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.[bds2]
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    \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.
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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 
U.S. Nuclear Regulatory Commission (NRC) or Agreement State.
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    \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.
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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
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    \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.
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    1. Any stolen, diverted, abandoned, or unrecovered lost 
radioactive material that

[[Page 45911]]

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.  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\8\ that is judged to be caused by theft or diversion.
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    \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.''
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    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.
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    \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.
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    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
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    \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).
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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.  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 performance 
issues of high safety significance.11
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    \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. ML101400045), 
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 ASP 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. ML15317A147), or under NRC IMC 0350, ``Oversight of 
Reactor Facilities in a Shutdown Condition Due to Significant 
Performance and/or Operational Concerns'' (ADAMS Accession No. 
ML063400076). 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

[[Page 45912]]

NRC[dash]regulated hazard (radiological or chemical).\15\
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    \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).
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    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\
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    \16\ Criteria III.A.2, III.A.3, and III.A.4 also apply to 
medical licensees.
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    1. A medical event, as defined in Sec.  35.3045, which results 
in a dose that:
    (a) 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) Exceeds, by 10 Gy (1,000 rad), the expected dose to any 
other organ or tissue from the administration defined in the written 
directive; and
    2. A medical event, as defined in Sec.  35.3045, which involves:
    (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.

Appendix B: Other Events of Interest

    This appendix discusses other events of interest that do not 
meet the criteria for abnormal occurrences (AOs) in Appendix A to 
this policy statement. The Commission may determine that events 
other than AOs may be of interest to Congress and the public and 
should be included in an appendix to the AO report as ``Other Events 
of Interest.'' Such events may include, but are not necessarily 
limited to, events that do not meet the AO criteria but that have 
been perceived by Congress or the public to be of high health or 
safety significance, have received significant media coverage, or 
have caused the U.S. Nuclear Regulatory Commission to increase its 
attention to or oversight of a program area, or a group of similar 
events that have resulted in licensed materials entering the public 
domain in an uncontrolled manner.

[FR Doc. 2017-21043 Filed 9-29-17; 8:45 am]
BILLING CODE 7590-01-P