```
[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]

=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: 
[email protected].

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.
---------------------------------------------------------------------------

    \\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.
---------------------------------------------------------------------------

    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).
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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).
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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
```