[Federal Register Volume 62, Number 74 (Thursday, April 17, 1997)]
[Notices]
[Pages 18820-18824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-9912]
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NUCLEAR REGULATORY COMMISSION
Abnormal Occurrence Reports: Implementation of Section 208 Energy
Reorganization Act of 1974; Revision to Policy Statement
AGENCY: Nuclear Regulatory Commission.
ACTION: Revise policy statement.
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SUMMARY: This policy statement presents the revised criteria the
Commission will use in submitting the annual abnormal occurrence (AO)
reports to Congress and the public in a timely manner as stated in
Section 208 of the Energy Reorganization Act of 1974, as amended. The
AO policy statement incorporates minor changes to implement the
Commission's direction to develop conforming changes as necessary and
revise criteria III., ``For Fuel Cycle Licensees,'' to include
facilities that are not licensed but are
[[Page 18821]]
otherwise regulated and will receive NRC certification such as gaseous
diffusion plants. The revision clarifies the AO criteria for all fuel
facilities including gaseous diffusion plants. Such revision provides
criteria which are more specific for fuel facilities in determining
those incidents and events that the Commission considers significant
from the standpoint of public health and safety for reporting to
Congress.
EFFECTIVE DATE: April 17, 1997.
ADDRESSES: The final policy statement published in the Federal Register
(December 19, 1996; 61 FR 67072) may be examined at the NRC Public
Document Room, 2120 L Street, NW. (Lower Level), Washington, DC.
FOR FURTHER INFORMATION CONTACT: Harriet Karagiannis, Office for
Analysis and Evaluation of Operational Data, U.S. Nuclear Regulatory
Commission, Washington, DC 20555, telephone: (301) 415-6377, internet:
hxk@nrc.gov.
SUPPLEMENTARY INFORMATION:
I. Background
II. The Commission Policy
I. Background
Section 208 of the Energy Reorganization Act of 1974 (Public Law
93-438, 42 U.S.C. 5848), as amended, required the Commission to submit
to Congress each quarter a report listing for that period any AOs at or
associated with any facility which is licensed or otherwise regulated
pursuant to the Atomic Energy Act of 1954, as amended, or pursuant to
this Act. In a letter to the Senate Subcommittee on Oversight of
Government Management, dated October 1, 1993, the NRC recommended to
Congress a change in the AO report publication frequency from quarterly
to yearly. As a result, Senate 790, ``Reports Elimination Act,'' Public
Law 104-66, was signed by President Clinton on December 21, 1995,
changing the AO report to a yearly publication.
For the purposes of Section 208 of the Energy Reorganization Act of
1974, as amended, an AO is an unscheduled incident or event which the
Commission has determined to be significant from the standpoint of
public health and safety. Each such report shall contain:
(1) The date and place of each occurrence;
(2) The nature and probable consequence of each occurrence;
(3) The cause or causes of each occurrence; and
(4) Any action taken to prevent recurrence.
The Commission also shall provide as wide dissemination to the
public of the information specified in clauses (1) and (2) of this
section as reasonably possible within 15 days of its receiving
information of each AO and shall provide as wide dissemination to the
public as reasonably possible of the information specified in clauses
(3) and (4) as soon as such information becomes available.
In July 1975, in the exercise of the authority conferred upon the
Commission by Congress to determine which unscheduled incidents or
events are significant from the standpoint of public health and safety
and are reportable to Congress as AOs, the Commission developed interim
criteria for evaluating licensee incidents or events. On the basis of
these interim criteria and as required by Section 208 of the Energy
Reorganization Act of 1974, as amended, the Commission began issuing
quarterly reports to Congress on AOs. These reports,1 ``Report to
Congress on Abnormal Occurrences,'' have been issued in NUREG-75/090
and NUREG-0090-1 through 5 for the period from January 1975 through
September 1976. On the basis of its experience in the preparation and
issuance of AO reports, the Commission issued a general statement of
policy that described the manner in which it would, as part of the
routine conduct of its business, carry out its responsibilities under
Section 208 of the Energy Reorganization Act of 1974, as amended, for
identifying AOs and making the requisite information concerning each
occurrence available to Congress and the public in a timely manner.
This general statement of policy was published in the Federal Register
on February 24, 1977 (42 FR 10950) and provided criteria and examples
of types of events that the Commission would use in determining whether
a particular event is reportable to Congress as an AO. The Commission
has since refined this statement of policy on a number of occasions to
reflect changes in regulation and policy. On the basis of these
criteria, and as required by Section 208 of the Energy Reorganization
Act of 1974, as amended, the Commission has issued quarterly reports to
Congress on AOs since March 1977. These reports, ``Report to Congress
on Abnormal Occurrences,'' have been issued in NUREG-0090-6 through 10
and NUREG-0090, Volumes 1 through 18.
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\\1 Copies of NUREGS may be purchased from the Superintendent of
Documents, U.S. Government Printing Office, (P.O. BOX 37082),
Washington, DC 20402-9328. Copies are also available from the
National Technical Information Service, 5285 Port Royal Road,
Springfield, VA 22161. A copy is available for inspection and/or
copying for a fee in the NRC Public Document Room, 2120 L Street, NW
(Lower Level), Washington, DC 20037.
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The Commission published a further revision to the AO policy
statement and criteria in the Federal Register on December 19, 1996 (61
FR 67072) to reflect changes in the Commission's policy and changes to
the regulations. In the Staff Requirements Memorandum dated November 7,
1996, SECY-96-193, approving this most recent revision to the AO
criteria the Commission directed the NRC staff to determine whether
modifications to criteria III., ``For Fuel Cycle Licensees,'' were
necessary to explicitly include fuel cycle facilities that are not
licensed but are otherwise regulated by NRC such as the gaseous
diffusion plants. The NRC staff evaluated the criteria applicable to
fuel cycle facilities and has revised the criteria as follows:
A. AO criteria published December 19, 1996:
III. For Fuel Cycle Licensees.
1. A required plant shutdown as a result of violating a license
condition or other safety limit.
2. A major condition not specifically considered in the license
that requires immediate remedial action.
3. An event that seriously compromises the ability of a confinement
system to perform its designated function.
B. Revised AO criteria to include gaseous diffusion plants:
IV. For Fuel Cycle Facilities.
1. A shutdown of the plant or portion of the plant resulting from a
significant event and/or violation of a law, regulation, or a license/
certificate condition.
2. A major condition or significant event not considered in the
license/certificate that requires immediate remedial action.
3. A major condition or significant event that seriously
compromises the ability of a safety system to perform its designated
function that requires immediate remedial action to prevent a
criticality, radiological or chemical process hazard.
It is expected that as additional experience is gained, further
changes in the criteria may be required.
Abnormal Occurrence Reporting
The AO statement of policy has been developed to comply with the
legislative intent of Section 208 of the Energy Reorganization Act of
1974, as amended, 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
[[Page 18822]]
health and safety concerns and is applicable to incidents and events
involving a single occupational worker as well as those having an
overall impact on the general public.
The policy statement contains criteria that include the reporting
thresholds for determining those incidents and events that are
reportable by NRC for the purposes of Section 208 of the Energy
Reorganization Act of 1974, as amended. The Commission has established
the reporting thresholds at a level that will ensure that all events
that should be considered for reporting to Congress will be identified.
At the same time, the thresholds are generally above the normal level
of reporting to NRC to exclude those events that involve some variance
from regulatory limits, but are not significant from the standpoint of
public health and safety.
Licensee Reports
This general statement of policy will not change the reporting
requirements imposed on NRC licensees by Commission regulations,
license conditions, or technical specifications (TS). NRC licensees
will continue to submit required reports on a wide spectrum of events,
including events such as instrument malfunctions and deviations from
normal operating procedures that are not significant from the
standpoint of the public health and safety, but do provide data useful
to the Commission in monitoring operating trends of licensed facilities
and in comparing the actual performance of these facilities with the
potential performance for which the facilities were designed and/or
licensed. Information pertaining to all events reported to the NRC will
continue to be made available and placed in the public document rooms
for public perusal. In addition, the NRC publishes annual reports on
events (NUREG-1272 series). Information can also be obtained by writing
to the U.S. Nuclear Regulatory Commission, Public Document Room, 2120 L
Street, NW. (Lower Level) Washington, DC 20555-0001. In addition, the
Commission will continue to issue news announcements on events that
seem to be newsworthy whether or not they are reported as AOs.
II. The Commission Policy--General Statement of Policy on
Implementation of Section 208 of the Energy Reorganization Act of
1974, as Amended
1. 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 2 or certified facilities. Reports will
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, or 72 of Chapter I, Title 10, Code of Federal
Regulations (10 CFR).
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\2\ In addition to the criteria listed in Appendix A, section
III, ``For Fuel Cycle Facilities,'' which are applicable to
licensees and certificate holders, such as the gaseous diffusion
plants (GDPs), other criteria of the policy statement which
reference ``licensees'' or ``licensed facility'' or ``licensed
material'' may also be applied to events at certified facilities
such as the GDPs.
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Through an exchange of information, Agreement States provide
information to the NRC on incidents and events involving applicable
nuclear materials that have occurred in their States. Those events
reported by Agreement States that reach the threshold for reporting as
an AO are also published in the ``Report to Congress on Abnormal
Occurrences.''
2. Definition of terms. As used in this policy statement:
(a) An ``abnormal occurrence'' means an unscheduled incident or
event at a facility or associated with an 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, that the
Commission determines to be significant from the standpoint of public
health and safety; and
(b) An ``unintended radiation exposure'' includes any occupational
exposure, exposure to the general public, or exposure as a result of a
medical misadministration (as defined in Sec. 35.2) involving the wrong
individual that exceeds the reporting values established in the
regulations.
All other reported medical misadministrations will be considered
for reporting as an AO under the criteria for medical licensees. In
addition, unintended radiation exposures include any exposure to a
nursing child, fetus, or embryo as a result of an exposure (other than
an occupational exposure to an undeclared pregnant woman) to a nursing
mother or pregnant woman above specified values.
3. 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 within the purview of
Section 208 of the Energy Reorganization Act of 1974, as amended.
An incident or event will be considered an AO if it involves a
major reduction in the degree of protection of the public health or
safety. This type of incident or event would have a moderate or more
severe impact on the 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;
(2) Major degradation of essential safety-related equipment; or
(3) Major deficiencies in design, construction, use of, or
management controls for facilities or radioactive material licensed by
or otherwise regulated by the Commission.
Criteria by type of event used to determine which incidents or
events will be considered for reporting as AOs are set out in Appendix
A of this policy statement.
4. Commission dissemination of AO information.
(a) The Commission will provide as wide a dissemination of
information to the public as reasonably possible. Information on
potential AOs (events that may meet the AO criteria) will be sent to
the NRC Public Document Room and all local public document rooms as
soon as possible after the staff determines that the incident is a
potential AO. A Federal Register notice will be issued on each AO
report with copies distributed to the NRC Public Document Room and all
local public document rooms. When additional information is
anticipated, the notice will state that the information can be obtained
at the NRC Public Document Room and in all local public document rooms.
(b) Each year, the Commission will submit a report to Congress
listing for that period any 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 will contain the date, place, nature,
and probable consequence of each AO, the cause or causes of each AO,
and any action taken to prevent recurrence.
Appendix A--Abnormal Occurrence Criteria
Criteria by types of events used to determine which incidents or
events will be considered for reporting as AOs are as follows:
[[Page 18823]]
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 millisievert (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 or tissue other than the lens of the eye, bone
marrow and the gonads, of 2500 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, and the gonads, of 1 Sv (100 rem) or
more; or an annual shallow-dose equivalent to the skin or
extremities of 2500 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
1. The release of radioactive material to an unrestricted area
in concentrations which, if averaged over a period of 24 hours,
exceed 5000 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 Secs. 20.1302 (b) (1) or 20.1302 (b) (2) (ii).
2. Radiation levels in excess of the design values for a
package, or the loss of confinement of radioactive material
resulting in one or more of the following: (a) a radiation dose rate
of 10 mSv (1 rem) per hour or more at 1 meter (3.28 feet) from the
accessible external surface of a package containing radioactive
material; (b) a radiation dose rate of 50 mSv (5 rem) per hour or
more on the accessible external surface of a package containing
radioactive material and that meet the requirements for ``exclusive
use'' as defined in 10 CFR 71.47; or (c) release of radioactive
material from a package in amounts greater than the regulatory
limits in 10 CFR 71.51(a)(2).
C. Theft, Diversion, or Loss of Licensed Material, or Sabotage or
Security Breach 3
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\3\ 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 Energy Reorganization Act of 1974, as amended.
Any classified details regarding these incidents would be available
to the Congress, upon request, under appropriate security
arrangements.
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1. Any lost, stolen, or abandoned sources that exceed 0.01 times
the A1 values, as listed in 10 CFR Part 71, Appendix A, Table
A-1, for special form (sealed/nondispersible) sources, or the
smaller of the A2 or 0.01 times the A1 values, as listed
in Table A-1, for normal form (unsealed/dispersible) sources or for
sources for which the form is not known. 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 during the time the source was missing; and
unrecoverable sources lost under such conditions that doses in
excess of the reporting thresholds specified in AO criteria I.A.1
and I.A.2 were not known to have occurred.
2. A substantiated case of actual or attempted theft or
diversion of licensed material or sabotage of a facility.
3. Any substantiated loss of special nuclear material or any
substantiated inventory discrepancy that is judged to be significant
relative to normally expected performance, and that is judged to be
caused by theft or diversion or by substantial breakdown of the
accountability system.
4. Any substantial breakdown of physical security or material
control (i.e., access control containment or accountability systems)
that significantly weakened the protection against theft, diversion,
or sabotage.
D. Other Events (i.e., Those Concerning Design, Analysis,
Construction, Testing, Operation, 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 requiring immediate
remedial action.
3. A serious deficiency in management or procedural controls in
major areas.
4. Series of events (where individual events are not of major
importance), recurring incidents, and incidents with implications
for similar facilities (generic incidents) that create a major
safety concern.
II. For Commercial Nuclear Power Plant Licensees
A. Malfunction of Facility, Structures, or Equipment
1. Exceeding a safety limit of license technical specification
(TS) [Sec. 50.36(c)].
2. Serious degradation of fuel integrity, primary coolant
pressure boundary, or primary containment boundary.
3. Loss of plant capability to perform essential safety
functions so that a release of radioactive materials, 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 system).
III. For Fuel Cycle Facilities
1. A shutdown of the plant or portion of the plant resulting
from a significant event and/or violation of a law, regulation, or a
license/certificate condition.
2. A major condition or significant event not considered in the
license/certificate that requires immediate remedial action.
3. A major condition or significant event that seriously
compromises the ability of a safety system to perform its designated
function that requires immediate remedial action to prevent a
criticality, radiological or chemical process hazard.
IV. For Medical Licensees
A medical misadministration that:
(a) Results in a dose that is (1) equal to or greater than 1
gray (Gy) (100 rads) to a major portion of the bone marrow, to the
lens of the eye, or to the gonads, or (2) equal to or greater than
10 Gy (1000 rads) to any other organ; and
(b) Represents either (1) a dose or dosage that is at least 50
percent greater than that prescribed in a written directive or (2) a
prescribed dose or dosage that (i) is the wrong
radiopharmaceutical,4 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(s).
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\4\ The wrong radiopharmaceutical as used in the AO criterion
for medical misadministrations refers to any radiopharmaceutical
other than the one listed in the written directive or in the
clinical procedures manual.
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V. Guidelines for ``Other Events of Interest''
The Commission may determine that events other than AOs may be
of interest to Congress and the public and be included in an
Appendix to the AO report as ``Other Events of Interest.''
Guidelines for events to be included in the AO report for this
purpose are items that may possibly be perceived by the public to be
of health or safety significance. Such items would not involve a
major reduction in the level of protection provided for public
health or safety; therefore, they would not be reported as abnormal
occurrences. An example is an event where upon final evaluation by
an NRC Incident Investigation Team, or an Agreement State equivalent
response, a determination is made that the event does
[[Page 18824]]
not meet the criteria for an abnormal occurrence.
Dated at Rockville, Maryland, this 11th day of April, 1997.
For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Acting Secretary of the Commission.
[FR Doc. 97-9912 Filed 4-16-97; 8:45 am]
BILLING CODE 7590-01-P
