[Federal Register Volume 71, Number 197 (Thursday, October 12, 2006)]
[Notices]
[Pages 60198-60200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-16871]
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
Abnormal Occurrence Reports: Implementation of Section 208 of the
Energy Reorganization Act of 1974; Revised Policy Statement
AGENCY: Nuclear Regulatory Commission.
ACTION: Issuance of Revised Policy Statement on Abnormal Occurrence
Criteria.
-----------------------------------------------------------------------
SUMMARY: This policy statement presents the revised abnormal occurrence
(AO) criteria the Commission uses for selecting AO's for the annual
report to Congress as required by Section 208 of the Energy
Reorganization Act of 1974 (Pub. L. 93-438). Section 208 of the act
defines an AO as an unscheduled incident or event which the U.S.
Nuclear Regulatory Commission (NRC) determines to be significant from
the standpoint of public health or safety. The AO criteria have been
amended to ensure that the criteria are consistent with the NRC's
Strategic Plan for Fiscal Year (FY) 2004-2009 and the NRC rulemaking on
Title 10, Part 35, of the Code of Federal Regulations (10 CFR Part 35),
``Medical Use of Byproduct Material.'' Additionally, risk-informed
criteria based on the NRC Accident Sequence Precursor (ASP) Program and
Reactor Oversight Process (ROP) have been added for selecting abnormal
occurrences at commercial nuclear power plants for the report to
Congress. The ASP program assesses the risk significance of issues and
events. The ROP is a risk-informed, tiered approach to ensuring the
safety of nuclear power plants. The ROP is a process for collecting
information about licensee performance, assessing the safety
significance of the information, taking appropriate actions, and
ensuring that licensees correct deficiencies. Some sections of the AO
criteria have been restructured. The restructuring accommodates the
changes in the criteria and minimizes duplication.
DATES: Effective Date: All revisions included in this publication are
complete and accurate as of September 21, 2006.
FOR FURTHER INFORMATION CONTACT: Sheryl A. Burrows, telephone: (301)
415-6086; e-mail: [email protected]; USNRC, Office of Nuclear Regulatory
Research, Mail Stop T9-F31, Washington, DC 20555-0001.
SUPPLEMENTARY INFORMATION:
I. Background
Section 208 of the Energy Reorganization Act of 1974 (Pub. L. 93-
438) defines an abnormal occurrence (AO) as an unscheduled incident or
event which the U.S. Nuclear Regulatory Commission (NRC) determines to
be significant from the standpoint of public health or safety. The
Federal Reports Elimination and Sunset Act of 1995 (Public Law 104-66)
requires that AOs be reported to Congress annually. Section 208
requires that the discussion of each event include 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 sending it to
Congress.
Abnormal Occurrence Reporting
The AO policy statement has been developed 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 which 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 overall impact
on the general public. The AO criteria results in reports to Congress
only for those events considered significant from the standpoint of
public health and safety.
Licensee Reports
This general policy statement will not change the reporting
requirements for NRC licensees in Commission regulations, license
conditions, or technical specifications (TS). NRC licensees will
continue to submit required reports on a wide range of events,
including instrument malfunctions and deviations from normal operating
procedures that are not significant from the standpoint of the public
health and safety but provide data useful to the Commission in
monitoring operating trends at licensed facilities and in comparing the
actual performance of the facilities with their design and/or licensing
basis.
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 36, 39, 40, 50, 61, 70, 71, 72 or 76 of 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. Events
reported by Agreements States that reach the threshold for reporting as
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 is an AO.
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 or otherwise regulated by the Commission,
(2) Major degradation of essential safety-related equipment, or
(3) Major deficiencies in the design, construction, or use of
management controls for facilities or radioactive material.
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 AO Information
The Commission widely disseminates the AO reports to the public.
The Commission submits an annual report to Congress on AOs at or
associated with any facility or activity which is licensed or otherwise
regulated pursuant to the Atomic Energy Act of 1954, as amended, or the
Energy Reorganization Act of 1974, as amended. This report gives the
date, place, nature, and probable consequences of each AO, the cause or
causes of each AO, and any actions taken to prevent recurrence.
[[Page 60199]]
Appendix A: Abnormal Occurrence Criteria
The following criteria are used to determine whether to consider
events for reporting as AOs:
I. For All Licensees
A. Human Exposure to Radiation from Licensed Material
1. Any unintended radiation exposure to an adult (any individual 18
years of age or older) resulting in an annual total effective dose
equivalent (TEDE) of 250 mSv (25 rem) or more; or an annual sum of the
deep dose equivalent (external dose) and committed dose equivalent
(intake of radioactive material) to any individual organ other than the
lens of the eye, the bone marrow, and the gonads of 2,500 mSv (250 rem)
or more; or an annual dose equivalent to the lens of the eye of 1 Sv
(100 rem) or more; or an annual sum of the deep dose equivalent and
committed dose equivalent to the bone marrow of 1 Sv (100 rem) or more;
or a committed dose equivalent to the gonads of 2,500 mSv (250 rem) or
more; or 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 a physician.
B. Discharge or dispersal of radioactive material from its intended
place of confinement which results in the release of radioactive
material to an unrestricted area in concentrations which, if averaged
over a period of 24 hours, exceeds 5,000 times the values specified in
Table 2 of Appendix B to 10 CFR Part 20, unless the licensee has
demonstrated compliance with Sec. 20.1301 using Sec. 20.1302(b)(1) or
Sec. 20.1302(b)(2)(ii).
This criterion does not apply to transportation events.
C. Theft, Diversion, or Loss of Licensed Material, or Sabotage or
Security Breach1 2
---------------------------------------------------------------------------
\1\ Information pertaining to certain incidents may be either
classified or under consideration for classification because of
national security implications. Classified information will be
withheld when formally reporting these incidents in accordance with
Section 208 of the ERA of 1974, as amended. Any classified details
regarding these incidents would be available to the Congress, upon
request, under appropriate security arrangements.
\2\ Due to increased terrorist activities worldwide, the AO
report would not disclose specific classified information and
sensitive information, the details of which are considered useful to
a potential terrorist. Classified information is defined as
information that would harm national security if disclosed in an
unauthorized manner.
---------------------------------------------------------------------------
1. Any unrecovered lost, stolen, or abandoned sources that exceed
the values listed in Appendix P to Part 110, ``High Risk Radioactive
Material, Category 2.'' Excluded from reporting under this criterion
are those events involving sources that are lost, stolen, or abandoned
under the following conditions: sources abandoned in accordance with
the requirements of 10 CFR 39.77(c); sealed sources contained in
labeled, rugged source housings; recovered sources with sufficient
indication that doses in excess of the reporting thresholds specified
in AO criteria I.A.1 and I.A.2 did not occur while the source was
missing; and unrecoverable sources (sources that have been lost and for
which a reasonable attempt at recovery has been made without success)
lost under such conditions that doses in excess of the reporting
thresholds specified in AO criteria I.A.1 and I.A.2 are not known to
have occurred and the agency has determined that the risk of theft or
diversion is acceptably low.
2. A substantiated \3\ case of actual theft or diversion of
licensed, risk-significant radioactive sources or a formula quantity
\4\ of special nuclear material; or act that results in radiological
sabotage.\5\
---------------------------------------------------------------------------
\3\ ``Substantiated'' means a situation where an indication of
loss, theft, or unlawful diversion such as: an allegation of
diversion, report of lost or stolen material, statistical processing
difference, or other indication of loss of material control or
accountability cannot be refuted following an investigation; and
requires further action on the part of the Agency or other proper
authorities.
\4\ A formula quantity of special nuclear material is defined in
10 CFR 70.4.
\5\ Radiological sabotage is defined in 10 CFR 73.2.
---------------------------------------------------------------------------
3. Any substantiated \3\ loss of a formula quantity \4\ of special
nuclear material or a substantiated \3\ inventory discrepancy of a
formula quantity \4\ of special nuclear material that is judged to be
caused by theft or diversion or by a substantial breakdown \6\ of the
accountability system.
---------------------------------------------------------------------------
\6\ A substantial breakdown is defined as a red finding in the
security inspection program, or any plant or facility determined to
have overall unacceptable performance, or in a shutdown condition
(inimical to the effective functioning of the nation's critical
infrastructure) as a result of significant performance problems and/
or operational events.
---------------------------------------------------------------------------
4. Any substantial breakdown \6\ of physical security or material
control (i.e., access control containment or accountability systems)
that significantly weakened the protection against theft, diversion, or
sabotage.
5. Any significant unauthorized disclosures (loss, theft, and/or
deliberate) of classified information that harms national security or
safeguards information that harms the public health and safety.
D. Initiation of High-Level NRC Team Inspections \7\
---------------------------------------------------------------------------
\7\ Initiation of any Incident Investigation Teams, as described
in NRC Management Directive (MD) 8.3, ``NRC Incident Investigation
Program,'' or initiation of any Accident Review Groups, as described
in MD 8.9, ``Accident Investigation.''
---------------------------------------------------------------------------
II. For 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 or 5 times the dose limits
of 10 CFR Part 50, Appendix A, General Design Criterion (GDC) 19, could
occur from a postulated transient or accident (e.g., loss of emergency
core cooling system, loss of control rod system).
B. Design or Safety Analysis Deficiency, Personnel Error, or Procedural
or Administrative Inadequacy
1. Discovery of a major condition not specifically considered in
the safety analysis report (SAR) or TS that requires immediate remedial
action.
2. Personnel error or procedural deficiencies that result in loss
of plant capability to perform essential safety functions so that a
release of radioactive materials which could result in exceeding the
dose limits of 10 CFR Part 100 or 5 times the dose limits of 10 CFR
Part 50, Appendix A, GDC 19, could occur from a postulated transient or
accident (e.g., loss of emergency core cooling system, loss of control
rod drive mechanism).
C. Any reactor events or conditions that are determined to be of
high safety significance.\8\
---------------------------------------------------------------------------
\8\ The NRC ROP uses four colors to describe the safety
significance of licensee performance. As defined in NRC Management
Directive 8.13, ``Reactor Oversight Process,'' 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 Abnormal Occurrences. Additionally, Criterion II.C also
includes any events or conditions evaluated by the NRC ASP program
to have a conditional core damage probability (CCDP) or change in
core damage probability (CDP) of greater than 1x10-3.
---------------------------------------------------------------------------
[[Page 60200]]
D. Any operating reactor plants that are determined to have overall
unacceptable performance or that are in a shutdown condition as a
result of significant performance problems and/or operational
event(s).\9\
---------------------------------------------------------------------------
\9\ Any plants assessed by the ROP to be in the unacceptable
performance column, as described in NRC Inspection Manual Chapter
0305, ``Operating Reactor Assessment Program.'' 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 of Licensed Facilities or Regulated
Materials
1. An accidental criticality [10 CFR 70.52(a)].
2. A major deficiency in design, construction, control, or
operation 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. For Fuel Cycle Facilities
1. Absence or failure of all safety-related or security-related
controls (engineered and human) for an NRC-regulated lethal hazard
(radiological or chemical) while the lethal hazard is present.
2. An NRC-ordered safety-related or security-related immediate
remedial action.
C. For Medical Licensees A medical event that:
1. Results in a dose that is
a. Equal to or greater than 1Gy (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. Equal to or greater than 10 Gy (1,000 rad) to any other organ or
tissue; and
2. Represents either
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.
IV. Other Events of Interest
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.
5 U.S.C. 552(a)]
Dated at Rockville, Maryland, this 5th day of October 2006.
For the U.S. Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. E6-16871 Filed 10-11-06; 8:45 am]
BILLING CODE 7590-01-P