[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)]
[Proposed Rules]
[Pages 49177-49181]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20260]
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NUCLEAR REGULATORY COMMISION
10 CFR Chapter I
[NRC-2015-0176]
Abnormal Occurrence Reports
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed revision to policy statement; request for comments.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is proposing
revisions to its policy statement on reporting abnormal occurrences
(AO) to Congress. The proposed revisions would clarify and restructure
the criteria used by the NRC and Agreement States for determining
whether to consider an incident or event as an AO. The proposed
revisions to the policy statement would ensure consistency with current
NRC guidance and
[[Page 49178]]
regulations. The NRC is requesting public comments on the proposed
revision to the policy statement at this time.
DATES: Submit comments by November 16, 2015. Comments received after
this date will be considered if it is practical to do so, but the
Commission is able to assure consideration only for comments received
on or before this date.
ADDRESSES: You may submit comments by any of the following methods
(unless this document describes a different method for submitting
comments on a specific subject):
Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0176. 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.
Mail comments to: Cindy Bladey, Office of Administration,
Mail Stop: OWFN-12-H08, U.S. Nuclear Regulatory Commission, Washington,
DC 20555-0001.
For additional direction on obtaining information and submitting
comments, see ``Obtaining Information and Submitting Comments'' in the
SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: Luis A. Benevides, Office of Nuclear
Regulatory Research, U.S. Nuclear Regulatory Commission, Washington DC
20555-0001; telephone: 301-415-2457; email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Obtaining Information and Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC-2015-0176 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 Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0176.
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 (if it is available
in ADAMS) is provided the first time that it is mentioned in the
SUPPLEMENTARY INFORMATION section.
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.
B. Submitting Comments
Please include Docket ID NRC-2015-0176 in the subject line of your
comment submission.
The NRC cautions you not to include identifying or contact
information that you do not want to be publicly disclosed in your
comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into
ADAMS. The NRC does not routinely edit comment submissions to remove
identifying or contact information.
If you are requesting or aggregating comments from other persons
for submission to the NRC, then you should inform those persons not to
include identifying or contact information that they do not want to be
publicly disclosed in their comment submission. Your request should
state that the NRC does not routinely edit comment submissions to
remove such information before making the comment submissions available
to the public or entering the comment into ADAMS.
II. Background
Section 208 of the Energy Reorganization Act of 1974, as amended
(Pub. L. 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. The Federal Reports Elimination and Sunset Act of
1995 (Pub. L. 104-66) requires that AOs be reported to Congress
annually. 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.
Abnormal Occurrence Reporting
The Commission has developed the AO policy statement to comply with
Section 208 of the Energy Reorganization Act of 1974, as amended. 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 and safety. The policy
reflects a range of health and 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 use a high
reporting threshold so that only those events considered significant
from the standpoint of public health and safety are reported to
Congress.
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 or
certified facilities. The reports 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 37, 39, 40, 50, 61, 70, 71, 72, or 76 in chapter I of
Title 10 of the Code of Federal Regulations (10 CFR).
Agreement States provide information to the NRC on incidents and
events involving applicable nuclear materials in their 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 AOs are also published in the ``Report to Congress on
Abnormal Occurrences.''
Proposed Revisions
The NRC is proposing revisions to the AO criteria to clarify the
criteria for determining events that are significant from the
standpoint of public health and safety and should therefore be
considered AOs. The proposed revisions would also make the criteria
consistent with NUREG-1614, Volume 6, ``U.S. Nuclear Regulatory
Commission's Strategic Plan for Fiscal Years 2014-2018,'' issued August
2014 (ADAMS Accession No. ML14246A439), and new NRC requirements in 10
CFR part 37, ``Physical protection of category 1 and category 2
quantities of radioactive material.'' Further, the NRC proposes to
revise the AO criteria to separate ``Other Events of Interest'' from
the AO criteria to clearly delineate that events considered ``Other
Events of Interest'' are not AOs, but do represent significant
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events that the Commission deems appropriate to report to Congress.
Finally, restructuring and minor editorial changes are proposed to some
sections for clarity.
The NRC is requesting public comments on the proposed revision to
the policy statement at this time. The NRC is specifically seeking
public comments on screening all reports for exposures to embryo/fetus
or nursing child as an AO under Criteria l.A.2, unintended radiation
exposure, versus screening reports required by 10 CFR 35.3047 for
exposures to embryo/fetus or nursing child resulting from treatment to
a patient as an AO under Criteria III.C, ``Events involving the Medical
Use of Radioactive Materials in Patients or Human Research Subjects.''
The entire text of the proposed revision of the policy statement is
available as an attachment to this document.
Licensee Reports
The proposed changes to the general policy statement would 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
the public health and safety but provide data useful to the Commission
in monitoring operating trends of licensed facilities and in comparing
the actual performance of these facilities with their design and/or
licensing basis.
III. Paperwork Reduction Act
This policy statement does not contain information collection
requirements that are subject to the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
Public Protection Notification
The NRC may not conduct or sponsor, and a person is not required to
respond to, a request for information or an information collection
requirement unless the requesting documents displays a currently valid
Office of Management and Budget control number.
Dated at Rockville, Maryland, this 10th day of August, 2015.
For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
Attachment--Abnormal Occurrence 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 abnormal occurrence (AO).\1\
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\1\ Events reported to the U.S. Nuclear Regulatory Commission
(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, 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.
The criteria for determining whether to consider an incident or
event for reporting as an AO are set forth in Appendix A of this policy
statement.
Commission Dissemination of Abnormal Occurrence Information
The Commission widely disseminates the AO reports to the public.
The Commission will submit an annual report to Congress on AOs that
occur at or are associated with any facility or 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.
This report gives the date, place, nature, and probable consequences of
each AO; the cause or causes of each AO; and any action taken to
prevent recurrence.
Appendix A: Abnormal Occurrence Criteria
An accident 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, 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 \2\
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\2\ Medical patients are excluded from consideration under this
criterion 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), which are considered in AO Criteria III.C, ``Events involving
the Medical Use of Radioactive Materials in Patients or Human
Research Subjects.''
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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
millisievert (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 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.
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\3\ Independent physician is defined to be 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, exceeds
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 10 CFR 20.1301, ``Dose limits for
individual members of the public,'' using 10 CFR 20.1302(b)(1) or 10
CFR 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 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
Executive Order 13526, as amended (``Classified National Security
Information'' (75 FR 707), or any predecessor or successor order to
require protection against unauthorized disclosures. Any classified
details about these incidents would be available to the Congress,
upon request, under appropriate security arrangements.
\5\ Information pertaining to certain incidents may be
Safeguards Information as defined in 10 CFR 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 the 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 to below the thresholds listed
in appendix A of 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 meets or exceeds the thresholds listed in
appendix A of 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 10 CFR 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 10
CFR 73.2, ``Definitions.''
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.
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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
10 CFR 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) of classified information that harms national security
or safeguards information that threatens public health and safety.
D. Initiation of High-Level NRC Team Inspection \10\
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\10\ This item addresses initiation of any incident
investigation teams, as described in NRC Management Directive (MD)
8.3, ``NRC Incident Investigation Program'' (see http://www.internal.nrc.gov/policy/directives/toc/md8.3.htm), or initiation
of any accident review groups, as described in MD 8.9, ``Accident
Investigation'' (see http://www.internal.nrc.gov/policy/directives/toc/md8.9.htm).
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II. Commercial Nuclear Power Plant Licensees
A. Malfunction of Facility, Structures, or Equipment
1. Exceeding a safety limit of license technical specification
(TS) (10 CFR 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, ``Reactor
Site Criteria,'' or five times the dose limits of General Design
Criteria (GDC) 19 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
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 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
Reactor Oversight Process (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'' (see http://www.internal.nrc.gov/policy/directives/toc/md8.13.htm), 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.
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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\
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\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.
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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\
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\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'' (see http://pbadupws.nrc.gov/docs/ML1508/ML15089A315.pdf), or under the NRC IMC
0350, ``Oversight of Reactor Facilities in a Shutdown Condition Due
to Significant Performance and/or Operational Concerns'' (see http://pbadupws.nrc.gov/docs/ML0634/ML063400076.pdf). This assessment of
safety performance is based on the number and significance of NRC
inspection findings and licensee performance indicators.
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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
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(generic incidents) that raise a major safety concern.
B. Fuel Cycle Facilities \14\
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\14\ Criterion III.A also applies to Fuel Cycle Facilities.
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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\
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\15\ High-consequence events for facilities licensed under 10
CFR part 70 are those that could seriously harm the worker or a
member of the public in accordance with 10 CFR 70.61. The integrated
safety analysis (ISA) conducted and maintained by the licensee or
applicant of 10 CFR part 70 fuel cycle facilities identifies such
hazards and the safety controls (10 CFR 70.62(c)) applied to meet
the performance requirements in accordance with 10 CFR 70.61(b)
through (d). Fuel cycle facilities licensed under 10 CFR part 40 or
certified under 10 CFR part 76 have licensing basis documents that
describe facility specific hazards, consequences, and those controls
utilized 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 NUREG-1520, Revision 2, Appendix A to Chapter 3, Section
A.2, under ``Consequence Category 3 (High Consequences)'' (see
http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1520/).
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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 10 CFR 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 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 10 CFR 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 AO criteria in Appendix A. 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 and safety significance, have received significant media
coverage, or have caused the NRC 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. 2015-20260 Filed 8-14-15; 8:45 am]
BILLING CODE 7590-01-P