[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