80 FR 49177 - Abnormal Occurrence Reports

NUCLEAR REGULATORY COMMISSION

Federal Register Volume 80, Issue 158 (August 17, 2015)

Page Range		49177-49181
FR Document		2015-20260
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 regulations. The NRC is requesting public comments on the proposed revision to the policy statement at this time.
Federal Register, Volume 80 Issue 158 (Monday, August 17, 2015)
[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)]
[Proposed Rules]
[Pages 49177-49181]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20260]


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

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.

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

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

[[Page 49179]]

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\
---------------------------------------------------------------------------

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

    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\
---------------------------------------------------------------------------

    \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.''
---------------------------------------------------------------------------

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

    \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.

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

[[Page 49180]]

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}
---------------------------------------------------------------------------

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

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

    \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.''
---------------------------------------------------------------------------

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

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

    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\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

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

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\
---------------------------------------------------------------------------

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

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\
---------------------------------------------------------------------------

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

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

[[Page 49181]]

(generic incidents) that raise a major safety concern.

B. Fuel Cycle Facilities \14\
---------------------------------------------------------------------------

    \14\ Criterion III.A also applies to Fuel Cycle Facilities.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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/).
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \16\ Criteria III.A.2, III.A.3, and III.A.4 also apply to 
medical licensees.
---------------------------------------------------------------------------

    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
Federal Register / Vol. 80, No. 158 / Monday, August 17, 2015 / Proposed Rules 49177

records’’ is a group of any records under investigatory and law enforcement circumstances and where it would not appear
the control of an agency from which activities. Specifically, the exemptions to interfere with or adversely affect the law
information is retrieved by the name of are required to: Preclude subjects of enforcement purposes of the systems from
the individual or by some identifying investigations from frustrating the which the information is recompiled or in
which it is contained. Exemptions from the
number, symbol, or other identifying investigative process; avoid disclosure above particular subsections are justified, on
particular assigned to the individual. In of investigative techniques; protect the a case-by-case basis to be determined at the
the Privacy Act, an individual is defined identities and physical safety of time a request is made, when information in
to encompass U.S. citizens and lawful confidential informants and of law this system of records is may impede a law
permanent residents. As a matter of enforcement personnel; ensure DHS’s enforcement, intelligence activities and
policy, DHS extends administrative and other federal agencies’ ability to national security investigation:
Privacy Act protections to all obtain information from third parties (a) From subsection (c)(3) (Accounting for
individuals where systems of records and other sources; protect the privacy of Disclosure) because making available to a
maintain information on U.S. citizens, third parties; and safeguard sensitive record subject the accounting of disclosures
lawful permanent residents, and non- from records concerning him or her would
information. specifically reveal any investigative interest
immigrant aliens. Nonetheless, DHS will examine each in the individual. Revealing this information
The Privacy Act allows government request on a case-by-case basis, and, could reasonably be expected to compromise
agencies to exempt certain records from after conferring with the appropriate ongoing efforts to investigate a violation of
the access and amendment provisions. If component or agency, may waive U.S. law, including investigations of a known
an agency claims an exemption, applicable exemptions in appropriate or suspected terrorist, by notifying the record
however, it must issue a Notice of circumstances and where it would not subject that he or she is under investigation.
Proposed Rulemaking to make clear to appear to interfere with or adversely This information could also permit the
the public the reasons why a particular affect the law enforcement or national record subject to take measures to impede the
exemption is claimed. investigation, e.g., destroy evidence,
security investigation.
DHS is claiming exemptions from intimidate potential witnesses, or flee the
Again, DHS will not assert any area to avoid or impede the investigation.
certain requirements of the Privacy Act exemption with respect to information (b) From subsection (e)(8) (Notice on
for DHS/CBP–001 Import Information maintained in the system that is Individuals) because to require individual
System System of Records. collected from a person and submitted notice of disclosure of information due to
No exemption shall be asserted with by that person’s air or vessel carrier, if compulsory legal process would pose an
respect to information maintained in the that person, or his or her agent, seeks impossible administrative burden on DHS
system as it relates to data submitted by access or amendment of such and other agencies and could alert the
or on behalf of a person who travels to information. subjects of counterterrorism or law
visit the United States, nor shall an enforcement investigations to the fact of
exemption be asserted with respect to List of Subjects in 6 CFR Part 5 those investigations when not previously
the resulting determination (authorized known.
Freedom of information, Privacy.
to travel, not authorized to travel, (c) From subsection (g)(1) (Civil Remedies)
For the reasons stated in the to the extent that the system is exempt from
pending).
preamble, DHS proposes to amend other specific subsections of the Privacy Act.
Some information in DHS/CBP–001
Chapter I of Title 6, Code of Federal Dated: July 31, 2015.
Import Information System System of
Records relates to official DHS national Regulations, as follows: Karen L. Neuman,
security, law enforcement or PART 5—DISCLOSURE OF RECORDS Chief Privacy Officer, Department of
intelligence activities. This system may Homeland Security.
AND INFORMATION
contain records or information [FR Doc. 2015–19726 Filed 8–14–15; 8:45 am]
pertaining to the accounting of ■ 1. The authority citation for Part 5 BILLING CODE 9111–14–P
disclosures made from IIS to other law continues to read as follows:
enforcement or intelligence agencies
Authority: Pub. L. 107–296, 116 Stat.
(Federal, State, local, foreign, 2135, 6 U.S.C. 101 et seq.; 5 U.S.C. 301. NUCLEAR REGULATORY COMMISION
international, or tribal) in accordance Subpart A also issued under 5 U.S.C. 552.
with the published routine uses. For the 10 CFR Chapter I
accounting of these disclosures only, in ■ 2. At the end of Appendix C to Part
accordance with 5 U.S.C. 552a(j)(2) and 5, add paragraph ‘‘74’’ to read as [NRC–2015–0176]
(k)(2), DHS will claim the original follows:
Abnormal Occurrence Reports
exemptions for these records or Appendix C to Part 5—DHS Systems of
information from subsection (c)(3), Records Exempt From the Privacy Act. AGENCY: Nuclear Regulatory
(e)(8), and (g) of the Privacy Act of 1974, Commission.
* * * * *
as amended, as necessary and 74. DHS/CBP–001, Import Information ACTION: Proposed revision to policy
appropriate to protect such information. System (IIS). A portion of the following statement; request for comments.
Moreover, DHS will add this exemption system of records is exempt from 5 U.S.C.
to Appendix C to 6 CFR part 5, DHS 552a(c)(3), (e)(8), and (g)(1) pursuant to 5 SUMMARY: The U.S. Nuclear Regulatory
Systems of Records Exempt from the U.S.C. 552a(j)(2), and from 5 U.S.C. Commission (NRC) is proposing
Privacy Act. Such exempt records or 552a(c)(3) pursuant to 5 U.S.C. 552a(k)(2). revisions to its policy statement on
information may be law enforcement or Further, no exemption shall be asserted with reporting abnormal occurrences (AO) to
mstockstill on DSK4VPTVN1PROD with PROPOSALS

national security investigation records, respect to information maintained in the Congress. The proposed revisions would
law enforcement activity and encounter system as it relates to data submitted by or clarify and restructure the criteria used
on behalf of a person who travels to visit the by the NRC and Agreement States for
records, or terrorist screening records. United States and crosses the border, nor
DHS needs these exemptions in order shall an exemption be asserted with respect
determining whether to consider an
to protect information relating to law to the resulting determination (approval or incident or event as an AO. The
enforcement investigations from denial). After conferring with the appropriate proposed revisions to the policy
disclosure to subjects of investigations component or agency, DHS may waive statement would ensure consistency
and others who could interfere with applicable exemptions in appropriate with current NRC guidance and

VerDate Sep<11>2014 16:52 Aug 14, 2015 Jkt 235001 PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 E:\FR\FM\17AUP1.SGM 17AUP1
Federal Register / Vol. 80, No. 158 / Monday, August 17, 2015 / Proposed Rules 49179

events that the Commission deems For the Nuclear Regulatory Commission. incident or event has a moderate or severe
appropriate to report to Congress. Annette L. Vietti-Cook, impact on public health or safety and could
Finally, restructuring and minor Secretary of the Commission. include, but need not be limited to, the
following:
editorial changes are proposed to some
Attachment—Abnormal Occurrence (1) Moderate exposure to, or release of,
sections for clarity. Statement of Policy radioactive material licensed by or otherwise
The NRC is requesting public The Commission will apply the regulated by the Commission or Agreement
comments on the proposed revision to States;
following policy in determining
the policy statement at this time. The (2) major degradation of essential safety-
whether an incident or event at a facility related equipment;
NRC is specifically seeking public or involving an activity that is licensed (3) major deficiencies in design,
comments on screening all reports for or otherwise regulated by the construction, use of, or management controls
exposures to embryo/fetus or nursing Commission or an Agreement State is an for facilities or radioactive material licensed
child as an AO under Criteria l.A.2, abnormal occurrence (AO).1 by or otherwise regulated by the Commission
unintended radiation exposure, versus An incident or event is considered an or Agreement States; or
screening reports required by 10 CFR AO if it involves a major reduction in (4) substantiated case of actual loss, theft,
35.3047 for exposures to embryo/fetus the protection of public health or safety. or diversion of risk-significant radioactive
or nursing child resulting from The incident or event has a moderate or material licensed by or otherwise regulated
treatment to a patient as an AO under severe impact on public health or safety by the Commission or Agreement States.
Criteria III.C, ‘‘Events involving the and could include, but need not be Abnormal Occurrence Criteria
Medical Use of Radioactive Materials in limited to, the following:
The following presents the criteria, by
Patients or Human Research Subjects.’’ (1) Moderate exposure to, or release
types of events, used to determine which
of, radioactive material licensed by or events will be considered for reporting as
The entire text of the proposed otherwise regulated by the Commission
revision of the policy statement is AOs.
or Agreement States;
available as an attachment to this (2) major degradation of essential I. All Licensees 2
document. safety-related equipment; A. Human Exposure to Radiation From
(3) major deficiencies in design, Licensed Material
Licensee Reports
construction, use of, or management
1. Any unintended radiation exposure to
The proposed changes to the general controls for facilities or radioactive
an adult (any individual 18 years of age or
policy statement would not change the material licensed by or otherwise older) resulting in:
reporting requirements for NRC regulated by the Commission or (a) An annual total effective dose
licensees in Commission regulations, Agreement States; or equivalent (TEDE) of 250 millisievert (mSv)
license conditions, or technical (4) substantiated case of actual loss, (25 rem) or more;
theft, or diversion of risk significant (b) an annual sum of the deep dose
specifications. The NRC licensees will
radioactive material licensed by or equivalent (external dose) and committed
continue to submit required reports on
otherwise regulated by the Commission dose equivalent (intake of radioactive
a wide range of events, including or Agreement States. material) to any individual organ other than
instrument malfunctions and deviations The criteria for determining whether the lens of the eye, the bone marrow, and the
from normal operating procedures that to consider an incident or event for gonads of 2,500 mSv (250 rem) or more;
may not be significant from the reporting as an AO are set forth in (c) an annual dose equivalent to the lens
standpoint of the public health and Appendix A of this policy statement. of the eye of 1 Sv (100 rem) or more;
safety but provide data useful to the (d) an annual sum of the deep dose
Commission in monitoring operating Commission Dissemination of Abnormal equivalent and committed dose equivalent to
trends of licensed facilities and in Occurrence Information the bone marrow of 1 Sv (100 rem) or more;
The Commission widely disseminates (e) a committed dose equivalent to the
comparing the actual performance of
the AO reports to the public. The gonads of 2,500 mSv (250 rem) or more; or
these facilities with their design and/or (f) an annual shallow dose equivalent to
licensing basis. Commission will submit an annual
the skin or extremities of 2,500 mSv (250
report to Congress on AOs that occur at rem) or more.
III. Paperwork Reduction Act or are associated with any facility or 2. Any unintended radiation exposure to
activity that is licensed or otherwise any minor (an individual less than 18 years
This policy statement does not
regulated pursuant to the Atomic Energy of age) resulting in an annual TEDE of 50
contain information collection Act of 1954, as amended, or the Energy mSv (5 rem) or more, or to an embryo/fetus
requirements that are subject to the Reorganization Act of 1974, as resulting in a dose equivalent of 50 mSv (5
Paperwork Reduction Act of 1995 (44 amended. This report gives the date, rem) or more.
U.S.C. 3501 et seq.). place, nature, and probable 3. Any radiation exposure that has resulted
consequences of each AO; the cause or in unintended permanent functional damage
Public Protection Notification
causes of each AO; and any action taken to an organ or a physiological system as
The NRC may not conduct or sponsor, to prevent recurrence. determined by an independent physician 3
deemed qualified by the NRC or Agreement
and a person is not required to respond
Appendix A: Abnormal Occurrence State.
to, a request for information or an Criteria
mstockstill on DSK4VPTVN1PROD with PROPOSALS

information collection requirement 2 Medical patients are excluded from
unless the requesting documents An accident or event is considered an
consideration under this criterion and these criteria
displays a currently valid Office of abnormal occurrence (AO) if it involves a
do not apply to medical events defined in § 35.3045
major reduction in the degree of protection of Title 10 of the Code of Federal Regulations (10
Management and Budget control of public health or safety. This type of CFR), which are considered in AO Criteria III.C,
number. ‘‘Events involving the Medical Use of Radioactive
Dated at Rockville, Maryland, this 10th day 1 Events reported to the U.S. Nuclear Regulatory Materials in Patients or Human Research Subjects.’’
of August, 2015. Commission (NRC) by Agreement States that reach 3 Independent physician is defined to be a

the threshold for reporting as AOs will be reported physician not on the licensee’s staff and who was
as such by the Commission. not involved in the care of the patient involved.

VerDate Sep<11>2014 16:52 Aug 14, 2015 Jkt 235001 PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 E:\FR\FM\17AUP1.SGM 17AUP1
49180 Federal Register / Vol. 80, No. 158 / Monday, August 17, 2015 / Proposed Rules

B. Discharge or Dispersal of Radioactive special nuclear material 8 or an inventory times the dose limits of GDC 19 in appendix
Material From Its Intended Place of discrepancy of a formula quantity of special A to 10 CFR part 50, could occur from a
Confinement nuclear material that is judged to be caused postulated transient or accident (e.g., loss of
The release of radioactive material to an by theft or diversion. emergency core cooling system, loss of
unrestricted area in concentrations that, if 4. Any substantial breakdown 9 of physical control rod drive mechanism).
averaged over a period of 24 hours, exceeds security, cyber security, or material control
and accountability programs that C. Any Operating Reactor Events or
5,000 times the values specified in Table 2 Conditions Evaluated by the NRC Reactor
of appendix B, ‘‘Annual Limits on Intake significantly weakens the protection against
loss, theft, diversion, or sabotage. Oversight Process (ROP) To Be the Result of
(ALIs) and Derived Air Concentrations or Associated With Licensee Performance
(DACs) of Radionuclides for Occupational 5. Any significant unauthorized
disclosures (loss, theft, and/or deliberate) of Issues of High Safety Significance 11
Exposure; Effluent Concentrations;
Concentrations for Release to Sewerage,’’ to classified information that harms national D. Any Operating Reactor Events or
10 CFR part 20, ‘‘Standards for protection security or safeguards information that Conditions Evaluated by the NRC Accident
against radiation,’’ unless the licensee has threatens public health and safety. Sequence Precursor (ASP) Program To Have
demonstrated compliance with 10 CFR D. Initiation of High-Level NRC Team a Conditional Core Damage Probability
20.1301, ‘‘Dose limits for individual members Inspection 10 (CCDP) or Change in Core Damage
of the public,’’ using 10 CFR 20.1302(b)(1) or Probability (DCDP) of Greater Than or Equal
10 CFR 20.1302(b)(2)(ii). This criterion does II. Commercial Nuclear Power Plant to 1 × 10¥3 12
not apply to transportation events. Licensees
E. Any Operating Reactor Plants That Are
C. Theft, Diversion, or Loss of Licensed A. Malfunction of Facility, Structures, or Determined To Have Overall Unacceptable
Material; Sabotage; or Security Breach 4 5 6 Equipment Performance or Are in a Shutdown Condition
1. Any stolen, diverted, abandoned, or 1. Exceeding a safety limit of license as a Result of Significant Performance
unrecovered lost radioactive material that technical specification (TS) (10 CFR Problems and/or Operational Event(s) 13
meets or exceeds the thresholds listed in 50.36(c)).
appendix A of 10 CFR part 37, ‘‘Physical III. Events at Facilities Other Than Nuclear
2. Serious degradation of fuel integrity,
protection of category 1 and category 2 Power Plants and All Transportation Events
primary coolant pressure boundary, or
quantities of radioactive material.’’ Excluded primary containment boundary. A. Events Involving Design, Analysis,
from reporting under this criterion are those 3. Loss of plant capability to perform Construction, Testing, Operation, Transport,
events involving sources that are lost or essential safety functions so that a release of Use, or Disposal
abandoned under the following conditions: radioactive materials, which could result in
Sources that have been lost and for which a 1. An accidental criticality.
exceeding the dose limits of 10 CFR part 100,
reasonable attempt at recovery has been 2. A major deficiency in design,
‘‘Reactor Site Criteria,’’ or five times the dose
made without success or irretrievable well construction, control, or operation having
limits of General Design Criteria (GDC) 19 in
logging sources as defined in 10 CFR 39.2, significant safety implications that require
appendix A, ‘‘General Design Criteria for
‘‘Definitions.’’ These sources are only immediate remedial action.
Nuclear Power Plants,’’ to 10 CFR part 50,
excluded if there is reasonable assurance that 3. A serious safety-significant deficiency in
‘‘Domestic licensing of production and
the doses from these sources have not management or procedural controls.
utilization facilities,’’ could occur from a
exceeded and will not exceed the reporting 4. A series of events (in which the
postulated transient or accident (e.g., loss of
thresholds specified in AO Criteria I.A.1 and individual events are not of major
emergency core cooling system, loss of
I.A.2 and the agency has determined that the importance), recurring incidents, or incidents
control rod system).
risk of theft or diversion is acceptably low. with implications for similar facilities
2. An act that results in radiological B. Design or Safety Analysis Deficiency,
sabotage as defined in 10 CFR 73.2, Personnel Error, or Procedural or 11 The NRC ROP uses four colors to describe the
‘‘Definitions.’’ Administrative Inadequacy safety significance of licensee performance. As
3. Any substantiated 7 case of actual theft, 1. Discovery of a major condition not defined in NRC MD 8.13, ‘‘Reactor Oversight
diversion, or loss of a formula quantity of specifically considered in the safety analysis Process’’ (see http://www.internal.nrc.gov/policy/
directives/toc/md8.13.htm), green is used for very
report or TS that requires immediate low safety significance, white is used for low to
4 Information pertaining to certain incidents may
remedial action. moderate safety significance, yellow is used for
be either classified or under consideration for 2. Personnel error or procedural
classification because of national security substantial safety significance, and red is used for
implications. Classified information will be
deficiencies that result in loss of plant high safety significance. Reactor conditions or
withheld when formally reporting these incidents capability to perform essential safety performance indicators evaluated to be red are
in accordance with Executive Order 13526, as functions so that a release of radioactive considered AOs.
12 Results from the NRC ASP program are used to
amended (‘‘Classified National Security materials, which could result in exceeding
Information’’ (75 FR 707), or any predecessor or the dose limits of 10 CFR part 100 or five monitor agency performance against the agency’s
successor order to require protection against strategic safety goal (e.g., ensure the safe use of
unauthorized disclosures. Any classified details radioactive materials) and objectives (e.g., prevent
about these incidents would be available to the diversion, such as: An allegation of diversion, and mitigate accidents and ensure radiation safety).
Congress, upon request, under appropriate security report of lost or stolen material, or other indication A precursor event with a CCDP or DCDP of greater
arrangements. of loss of material control or accountability that than or equal to 1 × 10¥3 is used as a performance
5 Information pertaining to certain incidents may cannot be refuted following an investigation; and indicator for the strategic safety goal by determining
be Safeguards Information as defined in 10 CFR requires further action on the part of the agency or that there have been no significant precursors of a
73.2 because of safety and security implications. other proper authorities. nuclear reactor accident and that there have been
8 Formula quantity of special nuclear material is
The AO report would withhold specific safeguards no more than one significant adverse trend in
information in accordance with Section 147 of the defined in 10 CFR 70.4, ‘‘Definitions.’’ industry safety performance.
Atomic Energy Act of 1954, as amended. Any 9 A substantial breakdown is defined as a red 13 Any plants assessed by the ROP to be in the
safeguards details regarding these incidents would finding under the Reactor Oversight Process (ROP) unacceptable performance column, as described in
be available to the Congress, upon request, under in the physical security inspection program or any NRC Inspection Manual Chapter (IMC) 0305,
appropriate security arrangements. plant or facility determined to have overall
mstockstill on DSK4VPTVN1PROD with PROPOSALS

‘‘Operating Reactor Assessment Program’’ (see
6 Reporting lost or stolen material is based on the unacceptable performance. http://pbadupws.nrc.gov/docs/ML1508/
activity of the source at the time the radioactive 10 This item addresses initiation of any incident ML15089A315.pdf), or under the NRC IMC 0350,
material was known to be lost or stolen. If, by the investigation teams, as described in NRC ‘‘Oversight of Reactor Facilities in a Shutdown
time the AO report is due to Congress, the Management Directive (MD) 8.3, ‘‘NRC Incident Condition Due to Significant Performance and/or
radioactive material has decayed to below the Investigation Program’’ (see http:// Operational Concerns’’ (see http://
thresholds listed in appendix A of 10 CFR part 37, www.internal.nrc.gov/policy/directives/toc/ pbadupws.nrc.gov/docs/ML0634/
the report will clarify that the radioactive material md8.3.htm), or initiation of any accident review ML063400076.pdf). This assessment of safety
has decayed below the thresholds. groups, as described in MD 8.9, ‘‘Accident performance is based on the number and
7 ‘‘Substantiated’’ means a situation in which Investigation’’ (see http://www.internal.nrc.gov/ significance of NRC inspection findings and
there is an indication of loss, theft, or unlawful policy/directives/toc/md8.9.htm). licensee performance indicators.

VerDate Sep<11>2014 16:52 Aug 14, 2015 Jkt 235001 PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 E:\FR\FM\17AUP1.SGM 17AUP1
Document Created: 2015-12-15 11:07:18
Document Modified: 2015-12-15 11:07:18
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Proposed revision to policy statement; request for comments.
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.
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]
FR Citation		80 FR 49177