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pdfNRC Enforcement Policy
January 28, 2013
Revised July 9, 2013
Interim Enforcement Policy (Section 9.2)
U. S. Nuclear Regulatory Commission
Office of Enforcement
Washington, DC 20555-00
NRC Enforcement Policy
NRC ENFORCEMENT POLICY
CONTENTS
PREFACE ............................................................................................................................... 3
1.0
INTRODUCTION ...................................................................................................... 4
1.1
1.2
1.3
1.4
1.5
1.6
2.0
NRC ENFORCEMENT PROCESS ........................................................................ 7
2.1
2.2
2.3
2.4
3.0
Purpose ................................................................................................................ 5
Applicability .......................................................................................................... 5
Statutory Authority ................................................................................................ 6
Regulatory Framework ......................................................................................... 6
Adequate Protection Standard ............................................................................. 6
Responsibilities……………………………………………………………………...... 7
Identification of Violations ................................................................................ 8
Assessment of Violations ................................................................................ 8
2.2.1 Factors Affecting Assessment of Violations......................................... 8
2.2.2 Traditional Enforcement.................................................................... 10
2.2.3 Operating Reactor Assessment Program .......................................... 11
2.2.4 Exceptions to Using Only the Operating Reactor
Assessment Program ........................................................................ 11
2.2.5 Export and Import of Nuclear Material
and Equipment .................................................................................. 12
2.2.6 Construction ...................................................................................... 12
Disposition of Violations ................................................................................ 13
2.3.1 Minor Violation ................................................................................... 13
2.3.2 Noncited Violation .............................................................................. 13
2.3.3 Notice of Violation ............................................................................. 15
2.3.4 Civil Penalty ....................................................................................... 15
2.3.5 Orders ............................................................................................... 23
2.3.6 Demand for Information ..................................................................... 23
2.3.7 Administrative Actions ....................................................................... 24
2.3.8 Reopening Closed Enforcement Actions ........................................... 24
2.3.9 Enforcement Guidance Memoranda .................................................. 24
2.3.10 Commission Notification and Consultation on Enforcement Actions . 24
2.3.11 Inaccurate and Incomplete Information ............................................. 25
2.3.12 Reporting Defects and Noncompliance ............................................. 27
Participation in the Enforcement Process...................................................... 27
2.4.1 Predecisional Enforcement Conference ............................................ 28
2.4.2 Regulatory Conference ...................................................................... 28
2.4.3 Alternative Dispute Resolution........................................................... 28
USE OF ENFORCEMENT DISCRETION ........................................................... 29
3.1
3.2
3.3
3.4
3.5
3.6
Violations Identified during Extended Shutdowns or Work Stoppages.......... 30
Violations Involving Old Design Issues ......................................................... 30
Violations Indentified Due to Previous Enforcement Actions......................... 31
Violations Involving Certain Discrimination Issues ........................................ 31
Violations Involving Special Circumstances .................................................. 32
Use of Discretion in Determining the Amount of a Civil Penalty ................... 32
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NRC Enforcement Policy
3.7
3.8
3.9
4.0
Exercise of Discretion To Issue Orders ........................................................ 33
Notices of Enforcement Discretion for Operating Power Reactors and
Gaseous Diffusion Plants .............................................................................. 33
Violations Involving Certain Construction Issues........................................... 34
ENFORCEMENT ACTIONS INVOLVING INDIVIDUALS ................................ 35
4.1
4.2
4.3
4.4
Considerations in Determining Enforcement Actions Involving Individuals ... 36
Notices of Violation and Orders to Individuals ............................................... 37
Civil Penalties to Individuals… ...................................................................... 38
Confirmatory Orders to Individuals ................................................................ 39
5.0
PUBLIC AVAILABILITY OF INFORMATION REGARDING
ENFORCEMENT ACTIONS ................................................................................. 39
6.0
VIOLATION EXAMPLES ...................................................................................... 39
6.1
6.2
6.3
6.4
6.5
6.6
6.7
6.8
6.9
6.10
6.11
6.12
6.13
6.14
6.15
Reactor Operations ....................................................................................... 40
Fuel Cycle Operations .................................................................................. 41
Materials Operations .................................................................................... 43
Licensed Reactor Operators ........................................................................ 47
Facility Construction (10 CFR Part 50 and 52 Licensees and Fuel Cycle
Facilities) ....................................................................................................... 50
Emergency Preparedness ............................................................................ 51
Health Physics ............................................................................................... 54
Transportation .............................................................................................. 57
Inaccurate and Incomplete Information or Failure to Make a Required
Report ........................................................................................................... 58
Discrimination ................................................................................................ 63
Reactor, Independent Spent Fuel Storage Installation,
Fuel Facility, and Special Nuclear Material Security ..................................... 65
Materials Security .......................................................................................... 66
Information Security ..................................................................................... 70
Fitness for Duty ............................................................................................. 71
Export and Import Activities……………………………………………………...72
7.0
GLOSSARY ............................................................................................................ 74
8.0
TABLE OF BASE CIVIL PENALTIES ................................................................ 79
9.0
INTERIM ENFORCEMENT POLICIES ............................................................... 80
9.1
9.2
10.0
Enforcement Discretion for Certain Fire Protection Issues (10 CFR 50.48)...80
Enforcement Discretion for Permanent Implant Brachytherapy
Medical Event Reporting (10 CFR 35.3045).................................................. 82
PAPERWORK REDUCTION ACT STATEMENT and
PUBLIC PROTECTION NOTIFICATION …………………………………………..83
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NRC Enforcement Policy
PREFACE
The U.S. Nuclear Regulatory Commission (referred to as the NRC, Commission, or
Agency) Enforcement Policy sets forth the general principles governing the NRC’s enforcement
program and the Commission’s expectations regarding the process to be used by the NRC to
assess and disposition violations of NRC requirements. However, this is a policy statement and
not a regulation. The Commission may deviate from this statement of policy as appropriate
under the circumstances of a particular case. The Policy also describes how organizations and
individuals subject to NRC enforcement actions can provide input to the process. A glossary is
provided which defines specific terms or words as they are used in the context of this Policy.
The NRC Enforcement Manual contains specific processes and guidance for implementing this
Policy. The guidance provided in the Enforcement Manual has been written to be consistent
with this Enforcement Policy. The Enforcement Manual appears on the NRC’s public Web site,
http://www.nrc.gov (select Public Meetings and Involvement, then Enforcement, then
Guidance, then Enforcement Manual or select Electronic Reading Room, ADAMS
Documents, and search ADAMS using accession number ML102630150).
A compilation of the statutes and materials pertaining to current nuclear regulatory legislation
can be found on the NRC webpage.
Changes to the NRC Enforcement Policy since it was first published with links to a summary of
each change and the Federal Register notice for each change are maintained on the NRC
Office of Enforcement (OE) webpage.
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NRC Enforcement Policy
1.0
INTRODUCTION
The mission of the NRC is to license and regulate the Nation’s civilian use of byproduct, source,
and special nuclear materials to ensure adequate protection of public health and safety,
promote the common defense and security, and protect the environment.
The following are some of the activities that the NRC performs as part of its mission:
a.
establishing requirements and guidance addressing the possession and use of source,
byproduct, and special nuclear material
b.
licensing applicants to use source, byproduct, and special nuclear material and construct
and operate licensed facilities in accordance with NRC requirements and specific license
conditions
c.
promoting the transparency and openness of the NRC’s enforcement program for all
stakeholders
Oversight of licensed activities ensures that licensees are complying with NRC requirements
and license conditions. Enforcement is an important part of the NRC’s oversight activities.
Figure 1. How the NRC Regulates
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NRC Enforcement Policy
1.1
Purpose
The NRC Enforcement Policy supports the NRC’s mission to ensure adequate protection of
public health and safety, promote the common defense and security, and protect the
environment. Adequate protection is presumptively assured by compliance with NRC
requirements. Compliance with NRC requirements, including regulations, technical
specifications, license conditions, and Orders, provides reasonable assurance to the NRC and
the public that safety and security are being maintained. The application of this Policy ensures
that associated enforcement actions properly reflect the safety or security significance of such
violations. Consistent with this objective, the Enforcement Policy endeavors to do the following:
a.
Deter noncompliance by emphasizing the importance of compliance with NRC
requirements.
b.
Encourage prompt identification and prompt comprehensive correction of violations of
NRC requirements.
1.2
Applicability
The Enforcement Policy applies to all NRC licensees and applicants, to various categories of
nonlicensees, and to individual employees of licensed and nonlicensed entities involved in
NRC-regulated activities. These include, but are not limited to the following:
a.
organizations and individuals holding NRC licenses
b.
license applicants
c.
contractors and subcontractors to NRC licensees
d.
holders of and applicants for various NRC approvals, including, but not limited to:
1.
2.
3.
4.
5.
6.
7.
8.
NRC certificates of compliance
early site permits
standard design certifications
quality assurance (QA) program approvals
certifications
limited work authorizations (LWA)
construction authorizations
other permits and forms of NRC approval
e.
vendors supplying safety-related components to NRC licensees
f.
employees of any of the above
Not all NRC requirements apply to all of the categories listed above; however, the Agency will
use the Enforcement Policy, as appropriate, to address violations of NRC requirements.
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NRC Enforcement Policy
It is NRC policy to hold licensees, certificate holders, and applicants responsible for the acts of
their employees, contractors, or vendors and their employees, and the NRC may cite the
licensee, certificate holder, or applicant for violations committed by its employees, contractors,
or vendors and their employees.
The NRC may use the term “licensee” in this Policy to generally refer not only to licensees, but
also to certificate holders and applicants.
1.3
Statutory Authority
The NRC derives its principal authority to license and regulate the civilian use of nuclear
materials from two statutes: (1) the Atomic Energy Act (AEA) of 1954, as amended, which
provides broad authority to license and regulate the civilian use of nuclear materials, and (2) the
Energy Reorganization Act (ERA) of 1974, as amended, which established the Agency and its
major offices. The Administrative Dispute Resolution Act of 1996 (ADRA), 5 U.S.C. §§ 571-584,
provides the statutory framework for the Federal Government to use alternative dispute
resolution (ADR).
1.4
Regulatory Framework
The NRC’s enforcement program is governed by its regulations. Title 10 of the Code of Federal
Regulations (10 CFR) Part 2, “Rules of Practice for Domestic Licensing Proceedings and
Issuance of Orders,” Subpart B, “Procedure for Imposing Requirements by Order, or for
Modification, Suspension, or Revocation of a License, or for Imposing Civil Penalties,” describes
the formal procedures that the NRC uses to implement its enforcement authority.
1.5
Adequate Protection Standard
Adequate protection of the public health and safety and assurance of the common defense and
security and protection of the environment are the NRC’s fundamental regulatory objectives.
Compliance with NRC requirements plays a critical role in giving the NRC confidence that safety
and security are being maintained. While adequate protection is presumptively assured by
compliance with NRC requirements, circumstances may arise where new information reveals
that an unforeseen hazard or security issue or security event exists or that a substantially
greater potential exists for a known hazard to occur. In such situations, the NRC has the
statutory authority to require action by licensees, their employees and contractors, and
certificate holders above and beyond existing regulations to maintain the level of protection
necessary to avoid undue risk to public health and safety, and to ensure security of materials.
The NRC also has the authority to exercise discretion to permit continued operations—despite
the existence of a noncompliance—where the noncompliance is not significant from a risk
perspective and does not, in the particular circumstances, pose an undue risk to public health
and safety. When noncompliance with NRC requirements occurs, the NRC must evaluate the
degree of risk posed by that noncompliance to determine whether immediate action is required.
If the NRC determines that the noncompliance itself is of such safety significance that adequate
protection is no longer provided, or that the noncompliance was caused by a failure of licensee
controls so significant that it calls into question the licensee’s ability to ensure adequate
protection, the NRC may demand immediate action, up to and including a shutdown or
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NRC Enforcement Policy
suspension of licensed activities. Based on the NRC’s evaluation of noncompliance, the
appropriate action could include refraining from taking any action, taking specific enforcement
action including the use of civil penalties, issuing Orders, or providing input to other regulatory
actions or assessments, such as increased NRC oversight of a licensee’s activities. Since
some requirements are more important to safety than others, the NRC endeavors to use a
risk-informed approach when applying NRC resources to the oversight of licensed activities,
including enforcement activities.
1.6
Responsibilities
The Executive Director for Operations (EDO) and the principal enforcement officers of the NRC,
the Deputy Executive Director for Reactor and Preparedness Programs (DEDR) and the Deputy
Executive Director for Materials, Waste, Research, State, Tribal, and Compliance Programs
(DEDMRT), have been delegated the authority to approve or issue all escalated enforcement
actions. The DEDMRT is responsible to the EDO for NRC enforcement programs. The Director,
OE, with some limitations, is delegated the authority by the DEDMRT to approve, sign, and
issue all enforcement actions and to oversee and implement the NRC enforcement program.1
Subject to the oversight and direction of the Director, OE, and with the approval of the
DEDMRT, where necessary, the regional offices normally issue notices of violation (NOVs) and
proposed civil penalties. Subject to the same oversight as the regional offices, the Directors of
the Office of Nuclear Reactor Regulation (NRR), the Office of Nuclear Material Safety and
Safeguards (NMSS), the Office of Federal and State Materials and Environmental Management
Programs (FSME), the Office of New Reactors (NRO), and the Office of Nuclear Security and
Incident Response (NSIR) may also approve, sign, and issue certain enforcement actions as
delegated by the Director, OE. The Director, OE, has delegated authority to the Directors of
NRR, NMSS, FSME, NRO, and NSIR to issue Orders not related to specific violations of NRC
requirements (i.e., nonenforcement-related Orders.) The Chief Financial Officer has been
delegated the authority to issue Orders where licensees violate Commission regulations by
nonpayment of license and inspection fees. (See NRC Enforcement Manual for a discussion of
delegation of enforcement authority.)
2.0
NRC ENFORCEMENT PROCESS
The NRC’s enforcement process has the following basic steps.
a.
b.
c.
First, violations must be identified.
Next, the NRC must assess the severity or significance of the violation.
Finally, the NRC must disposition the violation.
Throughout the process, an organization or individual subject to an NRC enforcement action
has multiple opportunities to provide input.
1
See NRC Enforcement Manual for additional information regarding the authority delegated to the Director,
OE.
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NRC Enforcement Policy
2.1
Identification of Violations
The enforcement process begins with the identification of violations, either through NRC
inspections or investigations, or through a licensee report, or by substantiation of an allegation.
All violations are subject to consideration for civil enforcement action; some violations may also
be considered for criminal prosecution by the U.S. Department of Justice. After a potential
violation is identified, it is assessed in accordance with this Policy. The NRC’s enforcement
assessment process is fact driven, performance based, and, when appropriate and possible,
risk informed. The NRC reviews each case being considered for enforcement action on its own
merits to ensure that the severity of a violation is characterized at the level appropriate to the
safety significance of the particular violation.
2.2
Assessment of Violations
After a violation is identified, the NRC assesses its severity or significance (both actual and
potential). Under traditional enforcement, the severity level (SL) assigned to the violation
generally reflects the assessment of the significance of a violation, and is referred to as
traditional enforcement. For most violations committed by operating power reactor licensees,
the significance of a violation is assessed using the significance determination process (SDP)
under the Reactor Oversight Process (ROP), as discussed below in Section 2.2.3, “Operating
Reactor Assessment Program.” All other violations will be assessed using traditional
enforcement as described in Section 2.2.4, “Exceptions to Using Only the Operating Reactor
Assessment Program.” Power reactor facilities under construction, independent spent fuel
storage installations (ISFSI), and nuclear materials facilities are not subject to the SDP and,
thus, traditional enforcement will be used for these facilities.
2.2.1
Factors Affecting Assessment of Violations
In determining the appropriate enforcement response to a violation, the NRC considers the four
specific factors discussed below. Whenever possible, the NRC uses risk information in
assessing the safety significance of violations and assigning severity levels. A higher severity
level may be warranted for violations that have greater risk, safety, or security significance,
while a lower severity level may be appropriate for issues that have lower risk, safety, or
security significance. Duration of the violation is also an appropriate consideration in assessing
the significance of the violation.
a.
Whether the violation resulted in actual safety or security consequences. In evaluating
actual consequences, the NRC considers issues such as whether the violation resulted
in the onsite or offsite releases of radiation or radiation exposures exceeding 10 CFR
Part 20, “Standards for Protection Against Radiation,” regulatory limits, onsite or offsite
chemical hazard exposures resulting from licensed or certified activities, accidental
criticality, core damage, loss of significant safety barriers, loss of control of radioactive
material or radiological emergencies, any violations during an actual General Emergency
that prevents offsite response organizations from implementing protective actions (under
their emergency plans) to protect public health and safety, or whether the security
system did not function as required and, as a result of the failure, a significant event or
an event that resulted in an act of radiological sabotage occurred.
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NRC Enforcement Policy
b.
Whether the violation had potential safety or security consequences. In evaluating
potential consequences, the NRC considers whether the violation created a credible
accident, security failure, or exposure scenario that could potentially have significant
actual consequences. For facilities under construction, the NRC considers the actual or
potential impact of the violation on the quality of construction and its resulting effect on
the safety and security of the facility.
c.
Whether the violation impacted the ability of the NRC to perform its regulatory oversight
function. The NRC considers the safety and security implications of noncompliances
that may affect the NRC’s ability to carry out its statutory mission. These types of
violations include failures to provide complete and accurate information; failures to
receive prior NRC approval for changes in licensed activities, when required; failures to
notify the NRC of required changes in licensed activities, when required; failures to
perform 10 CFR 50.59, “Changes, Tests and Experiments,” and similar analyses;
failures to maintain an up-to-date and accurate FSAR; and failures to comply with
reporting requirements, etc. Even inadvertent reporting failures are important because
many of the surveillance, quality control, and auditing systems on which both the NRC
and its licensees rely to monitor compliance with safety standards are based primarily on
complete, accurate, and timely recordkeeping and reporting. The existence of a
regulatory process violation does not automatically mean that the issue is significant to
safety or security. In determining the significance of a violation, the NRC will consider
appropriate factors for the particular regulatory process violation. These factors may
include the significance of the underlying issue, whether the failure actually impeded or
influenced regulatory action, the level of individuals involved in the failure and the reason
why the failure occurred given their position and training, and whether the failure
invalidates the licensing basis.
Unless otherwise categorized in the violation examples contained in this Policy (i.e.,
Section 6.0), the severity level of a violation involving the failure to make a required
report to the NRC will depend on the significance of and the circumstances surrounding
the matter that should have been reported. However, the severity level of an untimely
report, in contrast to no report, may be reduced depending on the circumstances. The
NRC will not normally cite a licensee for a failure to report a condition or event unless
the licensee was actually aware of the condition or event that it failed to report. On the
other hand, the Agency will normally cite a licensee for a failure to report a condition or
event if the licensee knew of the information to be reported and did not recognize that it
was required to make a report.
d.
Whether the violation involved willfulness. Willful violations are of particular concern
because the NRC’s regulatory program is based on licensees and their contractors,
employees, and agents acting with integrity and communicating with candor. The
Commission cannot tolerate willful violations. Therefore, a violation may be considered
more significant than the underlying noncompliance if it includes indications of
willfulness. Violations with willful aspects will typically be considered for escalated
enforcement (i.e., SL I, II, or III). The term “willfulness” as used in this Policy refers to
conduct involving either a careless disregard for requirements or a deliberate violation of
requirements or falsification of information. In determining the significance of a violation
involving willfulness, the NRC will consider such factors as the position, training,
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NRC Enforcement Policy
experience level, and responsibilities of the person involved in the violation (e.g.,
licensee official or nonsupervisory employee), the significance of any underlying
violation, the intent of the violator (i.e., careless disregard or deliberateness), and the
economic or other advantage, if any, gained as a result of the violation. The relative
weight given to each of these factors in the significance assessment will depend on the
circumstances of the violation. However, if a licensee refuses to correct a minor violation
within a reasonable time such that it willfully continues, the violation should be
considered at least more than minor. Licensees are expected to take significant
remedial action in responding to willful violations commensurate with the circumstances,
such that the action reflects the seriousness of the violation, thereby creating a deterrent
effect within the licensee’s organization.
2.2.2
Traditional Enforcement
Under its traditional enforcement process, the NRC assesses significance by assigning a
severity level to all violations by those subject to the NRC’s enforcement authority as defined in
Section 1.2, “Applicability of the Enforcement Policy,” and to some violations by operating power
reactor licensees. However, the Agency assesses most violations by operating power reactor
licensees under the ROP using the SDP (see Section 2.2.3). (Section 6.0 of this Policy
provides examples of SL I, II, III, and IV violations in 15 activity areas. These examples are not
intended to be exhaustive or controlling.)
In recognition that the regulation of nuclear activities in many cases does not lend itself to a
mechanistic treatment, judgment and discretion must be exercised in determining the severity
levels of the violations and the appropriate enforcement sanctions. This judgment and
discretion include the decision to issue an NOV, or to propose or impose a civil penalty and the
amount of this penalty, after considering the general principles of this statement of policy and
the significance of the violations, as well as the surrounding circumstances.
Severity level designations reflect different degrees of significance depending on the activity
area in which the severity level is designated. For example, the immediacy of any hazard to the
public associated with SL I in reactor operations is not directly comparable to that associated
with SL I violations in facility construction.
a.
SL I violations are those that resulted in or could have resulted in serious safety or
security consequences (e.g., violations that created the substantial potential for serious
safety or security consequences or violations that involved systems failing when actually
called on to prevent or mitigate a serious safety or security event).
b.
SL II violations are those that resulted in or could have resulted in significant safety or
security consequences (e.g., violations that created the potential for substantial safety or
security consequences or violations that involved systems not being capable, for an
extended period, of preventing or mitigating a serious safety or security event).
c.
SL III violations are those that resulted in or could have resulted in moderate safety or
security consequences (e.g., violations that created a potential for moderate safety or
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NRC Enforcement Policy
security consequences or violations that involved systems not being capable, for a
relatively short period, of preventing or mitigating a serious safety or security event).
d.
SL IV violations are those that are less serious, but are of more than minor concern, that
resulted in no or relatively inappreciable potential safety or security consequences (e.g.,
violations that created the potential of more than minor safety or security
consequences).
e.
Minor Violations are those that are less significant than a SL IV violation. Minor
violations do not warrant enforcement action and are not normally documented in
inspection reports. However, minor violations must be corrected.
2.2.3
Operating Reactor Assessment Program
The assessment, disposition, and subsequent NRC action related to inspection findings
identified at operating power reactors are determined by the ROP, as described in NRC
Inspection Manual Chapter (IMC) 0305, “Operating Reactor Assessment Program.” Inspection
findings identified through the ROP are assessed for safety significance using the SDP
described in IMC 0609, “Significance Determination Process.” The SDP uses risk insights,
where possible, to assist the NRC staff in determining the safety or security significance of
inspection findings identified within the ROP. Inspection findings processed through the SDP,
including associated violations, are documented in inspection reports and are assigned one of
the following colors, depending on their safety significance
a.
b.
c.
d.
red—inspection findings with high safety or security significance
yellow—inspection findings with substantial safety or security significance
white—inspection findings with low-to-moderate safety or security significance
green—inspection findings with very low safety or security significance
With the exceptions noted below in Section 2.2.4, violations associated with ROP inspection
findings are not normally assigned severity levels, nor are they normally subject to civil
penalties, although civil penalties are considered for any violation that involves actual
consequences.
2.2.4
Exceptions to Using Only the Operating Reactor Assessment Program
Some aspects of inspection findings and their associated violations at operating power reactors
cannot be addressed only through the Operating Reactor Assessment Program. Operating
reactor inspection findings are assigned significance and any associated violations involving
traditional enforcement are assigned severity levels and can be considered for civil penalties
(see IMC 0612). In determining the severity level assigned to such violations, the NRC will
consider information in this Policy and the violation examples in Section 6.0 of this Policy, as
well as SDP-related information, when available. Typically, the types of violations dispositioned
using traditional enforcement include the following:
a.
violations that resulted in actual safety or security consequences (as described in
Section 2.2.1.a)
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NRC Enforcement Policy
b.
violations that may impact the ability of the NRC to perform its regulatory oversight
function (as described in 2.2.1.c)
c.
violations involving willfulness (as described in Section 2.2.1.d)
d.
violations of NRC requirements for which there are no associated SDP performance
deficiencies (e.g., a violation of TS which is not a performance deficiency.) These
violations are normally dispositioned using discretion, similar to that described in
Section 3.2 of this Policy.
2.2.5
Export and Import of Nuclear Equipment and Material
The NRC will normally take enforcement action for violations of the Agency’s export and import
requirements in 10 CFR Part 110, “Export and Import of Nuclear Equipment and Material,” for
radioactive material and equipment within the scope of the NRC’s export and import licensing
authority (10 CFR 110.8, 110.9, and 110.9a) for (1) completeness and accuracy of information,
(2) reporting and recordkeeping requirements (10 CFR 110.23, 110.26, 110.50, and 110.54),
and (3) adherence to general and specific licensing requirements (10 CFR 110.20-27 and 10
CFR 110.50).
2.2.6
Construction
In accordance with 10 CFR 50.10, no person may begin the construction of a production
or utilization facility on a site on which the facility is to be operated until that person has
been issued either a construction permit under 10 CFR Part 50, a combined license
under 10 CFR Part 52, an early site permit authorizing the activities under
10 CFR 50.10(d), or a limited work authorization under 10 CFR 50.10(d). In an effort to
preclude unnecessary regulatory burden, while maintaining safety, the Changes during
Construction (CdC) Process, as developed in Interim Staff Guidance (ISG)- 025, permits
the licensee to proceed with the installation and testing of structures, systems or
components different from the current licensing basis while the license amendment
request (LAR) is under NRC review. Any activities undertaken under the CdC process
are at the risk of the licensee, and the licensee is obligated to return to the current
licensing basis (CLB) if the related LAR is subsequently not approved by the NRC.
Failure to timely restore the CLB may be subject to separate enforcement, such as an
order, a civil penalty, or both.
In accordance with 10 CFR 70.23(a)(7) and 10 CFR 40.32(e), commencement of
construction before the NRC finishes its environmental review and issues a license for
processing and fuel fabrication, conversion of uranium hexafluoride, or uranium
enrichment facility construction and operation is grounds for denial to possess and use
licensed material in the plant or facility. Additionally, in accordance
with10 CFR 70.23(b), failure to obtain Commission approval for the construction of the
principal structures, systems, and components of a plutonium processing and fuel
fabrication plant before the commencement of construction may also be grounds for
denial of a license to possess and use special nuclear material.
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NRC Enforcement Policy
2.3
Disposition of Violations
This section describes the various ways that the NRC can disposition violations.
2.3.1
Minor Violation
Violations of minor safety or security concern generally do not warrant enforcement action or
documentation in inspection reports but must be corrected. Examples of minor violations can
be found in the NRC Enforcement Manual and in IMC 0612, “Power Reactor Inspection
Reports” (Appendix E, “Examples of Minor Issues”). Guidance for documenting minor violations
can be found in the NRC Enforcement Manual; IMC 0610, “Nuclear Material Safety and
Safeguards Inspection Reports”; IMC 0612; IMC 0613, “Documenting 10 CFR Part 52
Construction and Test Inspections”; IMC 0616, “Fuel Cycle Safety and Safeguards Inspection
Reports”; and IMC 0617, “Vendor and Quality Assurance Implementation Inspection Reports.”
2.3.2
Noncited Violation
SL IV violations and violations associated with green ROP findings (for operating reactors) are
normally dispositioned as noncited violations (NCVs). Inspection reports or inspection records
document NCVs and briefly describe the corrective action the licensee or nonlicensee has taken
or plans to take, if known. Licensees and nonlicensees are not required to provide written
responses to NCVs; however, they may provide a written response if they disagree with the
NRC’s description of the NCV or dispute the validity of the NCV. Typically, all of the criteria in
either 2.3.2.a or b must be met for the disposition of a violation as an NCV.
For all SL IV violations identified by the NRC at fuel cycle facilities (under construction or
in operation) in accordance with 10 CFR Part 70 or 10 CFR Part 40 and reactors under
construction in accordance with 10 CFR Part 50 or 10 CFR Part 52, before the NRC
determines that an adequate corrective action program has been implemented, the NRC
normally issues a Notice of Violation. Until the determination that an adequate corrective
action program has been implemented, NCVs may be issued for SL IV violations if the
NRC has determined that the applicable criteria in 2.3.2.b. below are met. For reactor
licensees, after the NRC determines that an adequate corrective action program has
been implemented, the NRC will normally issue an NCV in lieu of an SL IV violation,
whether that violation is identified by the licensee or the NRC.
a.
Licensees and Nonlicensees with a Corrective Action Program2
1.
The licensee or nonlicensee must place the violation into a corrective action
program to restore compliance and address recurrence.
2.
The licensee or nonlicensee must restore compliance (or demonstrate objective
evidence of plans to restore compliance) within a reasonable period of time (i.e.,
in a timeframe commensurate with the significance of the violation) after a
violation is identified.
2
The NRC will credit a formal corrective action program that has been inspected and found to meet regulatory
guidance, industry standards, or both.
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NRC Enforcement Policy
3.
The violation must either not be repetitive3 as a result of inadequate corrective
action, or, if repetitive, the repetitive violation must not have been identified by
the NRC. This criterion does not apply to violations associated with green ROP
findings.
4.
The violation must not be willful. Notwithstanding willfulness, an NCV may still
be appropriate in the following circumstances:
(a)
The licensee or nonlicensee identified the violation and promptly provided
the information concerning the violation, if not required to be reported, to
appropriate NRC personnel, such as a resident inspector or regional
branch chief.
(b)
The violation involved the acts of an individual in a low-level position
within the licensee’s or nonlicensee’s organization (and not a licensee or
nonlicensee official as defined in Section 7.0, “Glossary”).
(c)
The violation appears to be the isolated action of the employee without
management involvement, and the violation was not caused by lack of
management oversight as evidenced by either a history of isolated willful
violations or a lack of adequate audits or supervision of employees.
(d)
The licensee or nonlicensee took significant remedial action
commensurate with the circumstances. This action demonstrated the
seriousness of the violation to other employees and contractors, thereby
creating a deterrent effect within the licensee’s or nonlicensee’s
organization.
The approval of the Director, OE, is required to disposition willful violations as
NCVs.
b.
All Other Licensees and Nonlicensees
1.
The licensee or nonlicensee identified the violation.4
2.
The licensee or nonlicensee corrected or committed to correcting the violation
within a reasonable period of time by specific corrective action committed to by
the end of the inspection, including immediate corrective action and
comprehensive action to prevent recurrence.
3
A violation is considered “repetitive” if it could reasonably be expected to have been prevented by the
licensee's corrective action for a previous violation. In addition, a violation is considered “repetitive” if a previous
licensee finding occurred within the past 2 years of the inspection at issue, or the period between the last two
inspections, whichever is longer.
4
An NOV is warranted when a licensee or nonlicensee identifies a violation as a result of an event where the
root cause of the event is obvious or the licensee had prior opportunity to identify the problem but failed to take action
that would have prevented the event. Disposition as an NCV may be warranted if the licensee or nonlicensee
demonstrated initiative in identifying the violation’s root cause.
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NRC Enforcement Policy
3.
The violation is not repetitive as a result of inadequate corrective action.
4.
The violation is not willful. Notwithstanding willfulness, an NCV may still be
appropriate if it meets the criteria in Section 2.3.2.a.4 above.
The approval of the Director, OE, is required to disposition willful violations as NCVs.
2.3.3
Notice of Violation
A Notice of Violation (NOV) (see 10 CFR 2.201, “Notice of Violation”) is a written notice setting
forth one or more violations of a legally binding requirement and normally requires the recipient
to provide a written response describing (1) the reasons for the violation or, if contested, the
basis for disputing the violation, (2) the corrective steps that have been taken by the licensee or
other person and the results achieved, (3) the corrective steps that will be taken, and (4) the
date when full compliance will be achieved. The NRC may waive all or portions of a written
response to the extent that relevant information has already been provided to the NRC in writing
or documented in an NRC inspection report or inspection record. The NRC may require
responses to NOVs to be under oath; however, normally, responses under oath will be
considered necessary only for SL I, II, or III violations; violations assessed using the SDP as
white, yellow, or red; or violations of NRC Orders. A civil penalty may be issued in conjunction
with an NOV.
2.3.4
Civil Penalty
A civil penalty (see 10 CFR 2.205, “Civil Penalties”) is a monetary penalty that the NRC may
impose for violations of (1) certain specified licensing provisions of the AEA or supplementary
NRC rules or Orders, (2) any requirement for which a license may be revoked, (3) reporting
requirements under Section 206 of the ERA, or (4) any NRC rule adopted under Section 147 of
the AEA with respect to safeguards information. Based on the circumstances of a specific case,
the NRC may increase a civil penalty where application of the guidance in this Policy would
normally result in a zero penalty or a base civil penalty, to ensure that the proposed civil penalty
reflects the safety significance of the case. The NRC’s policy of imposing graduated civil
penalties generally takes into account the gravity of the violation as the primary consideration
and the ability to pay as a secondary consideration. Thus, operations involving greater nuclear
material inventories, significantly higher consequences resulting from a release or exposure to
radioactive material, and consequences to the public and workers receive higher civil penalties.
Regarding the secondary factor of the ability of various classes of licensees to pay the civil
penalties, it is not the NRC’s intention that the economic impact of a civil penalty be so severe
that it adversely affects a licensee’s ability to safely conduct licensed activities or puts a licensee
out of business (Orders, rather than civil penalties, are used when the NRC’s intent is to
suspend or terminate licensed activities).
Civil penalties are considered for all SL I, II, and III violations. The civil penalty assessment
process described in this section and depicted in Figure 2 should be followed to determine the
appropriateness of a civil penalty for any escalated enforcement action. Notwithstanding the
outcome of the normal civil penalty assessment process, discretion, as discussed in this section
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NRC Enforcement Policy
and in Section 3.6, “Use of Discretion in Determining the Amount of a Civil Penalty,” may be
exercised by either escalating or mitigating the amount of the civil penalty.
Violations assessed under the SDP normally are not considered for civil penalties. However,
civil penalties are considered for violations associated with inspection findings evaluated
through the ROP’s SDP that involve actual consequences.
The NRC may exercise discretion and assess a separate violation and attendant civil
penalty up to the statutory limit for each day the violation continues (i.e., daily civil
penalties). The NRC may exercise this discretion when a licensee was aware of a
violation of at least moderate significance (i.e., at least a SL III) and had a clear
opportunity to prevent, identify, and correct the violation but failed to do so.
In evaluating whether daily civil penalties are appropriate, the NRC will consider such
factors as whether the violation resulted in actual consequences to public health and
safety or to the common defense and security, the safety significance of the violation,
whether the violation was repetitive because of inadequate corrective actions, the
degree of management culpability in allowing the violation to continue or in not
precluding it, the responsiveness of the licensee once the violation and its significance
were identified and understood, whether the continuing violation was willful, and the
duration of the violation. These evaluation factors are not necessarily of equal
significance; therefore, for each case, the NRC will weigh the relative importance of each
contributing factor, as well as any extenuating circumstances, to determine whether it is
appropriate to use daily civil penalties.
When the NRC determines that the use of daily civil penalties is appropriate as part of
an enforcement action, the Agency will assess a base civil penalty for the first day of the
violation in accordance with the civil penalty assessment process discussed in this
section and Section 8.0, “Table of Base Civil Penalties,” of the Policy. Then, to
determine the total civil penalty for the continuing violation, the NRC will supplement the
base civil penalty determination with a daily civil penalty for some or all of the days the
violation continues. The NRC will determine the amount of the daily civil penalty on a
case-by-case basis after considering the factors noted in the preceding paragraph and
any relevant past precedent for similar violations. The daily civil penalty may be less
than the maximum statutory daily limit in effect at the time of the violation.
The NRC considers civil penalties for violations associated with loss of regulated material (i.e.,
the NRC’s lost source policy). The loss of NRC-regulated material is a significant regulatory and
security concern because of the potential unauthorized possession or use of the material and
because of the potential for overexposure to members of the public from its misuse. Such
violations may include but are not limited to the loss, abandonment, improper
transfer, or improper disposal of a device, source, or other form of regulated material.
Notwithstanding the normal civil penalty assessment process, in cases where a licensee has
lost its regulated radioactive material, the NRC may exercise discretion and impose a civil
penalty. However, the Agency may mitigate or escalate a civil penalty amount based on the
merits of a specific case. When appropriate, the NRC may consider, for example, information on
the estimated or actual cost of authorized disposal and the actual consequences of the material
remaining out of the control of the licensee, as well as any effect on radiation workers or the
environment. Normally, the NRC will not apply the lost source policy to generally licensed
16
NRC Enforcement Policy
devices that are not required to be registered in accordance with 10 CFR 31.5(c)(13)(i). The
NRC will continue to apply the normal Enforcement Policy in those cases where licensees have
lost control of regulated material.
The Commission recognizes that violations occur in a variety of activities and have varying
impacts; therefore, the civil penalty Tables A and B in Section 8.0 of this Policy contain
graduated sanctions based on the severity level of the violation. The tables present the base
civil penalty (i.e., normal civil penalty, for any severity level violation for each type of licensee
before consideration of factors to either escalate or use discretion to increase or decrease those
amounts). The civil penalty amounts applied should be those in effect at the time of the
violation.
The flow chart (Figure 2) presented below is a graphic representation of the civil penalty
assessment process.
The civil penalty assessment process considers four decision points. Although each of these
decision points may have several associated considerations for any given case, the outcome of
the assessment process for each violation or problem, absent the exercise of discretion, is
limited to one of the following three results: no civil penalty, a base civil penalty, or a base civil
penalty escalated by 100 percent. The four decision points are the following:
a.
Did the licensee have any previous escalated enforcement action (regardless of the
activity area) within the past 2 years of the inspection at issue, or the period between the
last two inspections, whichever is longer? When the NRC determines that a nonwillful
SL III violation or problem has occurred, and the licensee has not had any previous
escalated actions (regardless of the activity area) during the past 2 years or two
inspections, whichever period is longer, the NRC will consider whether the licensee’s
corrective action for the present violation or problem is reasonably prompt and
comprehensive (see the discussion under Section 2.3.4.c, below). Using 2 years as the
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NRC Enforcement Policy
basis for assessment is expected to cover most situations, but considering a slightly
longer or shorter period may be warranted based on the circumstances of a particular
case. For a licensee-identified violation or an event, the starting point of this period is
when the licensee becomes aware that a problem or violation exists that requires
corrective action. For an NRC-identified violation, the starting point is when the NRC put
the licensee on notice of the need to take corrective action for the previous violation,
which could be during the inspection, at the inspection exit meeting, or as part of post
inspection communication with the licensee. The 2 year period typically ends on the
date of the second violation.
b.
Should the licensee be given credit for actions related to identification of the violation?
A stated purpose of this Policy is to encourage prompt identification of violations of NRC
requirements. While the decision regarding credit for identification can become
complicated, the overarching consideration is whether the NRC should give credit for a
licensee’s efforts to identify the violation. It is the responsibility of the licensee to bring
information on efforts to identify the violation to the attention of the NRC. The NRC will
not undertake an inquiry to obtain information on whether identification credit is
warranted.
1.
The civil penalty assessment should normally consider the factor of identification,
in addition to corrective action (see the discussion in Section 2.3.4.c, below). In
these circumstances, the NRC should consider whether the licensee should be
given credit for actions related to identification when any of the following
conditions exist:
(a)
the violation is a SL I or II
(b)
the violation is a willful SL III
(c)
the licensee has been issued at least one other escalated action during
the past 2 years or 2 inspections, whichever is longer.
In each case, the decision should be focused on identification of the problem
requiring corrective action. In other words, although giving credit for identification
and corrective action should be separate decisions, the concept of identification
presumes that the identifier recognizes the existence of a problem and
understands that corrective action is needed. The decision on identification
requires considering all the circumstances of identification including the following:
(a)
whether the problem requiring corrective action was identified by the
NRC, identified by the licensee, or revealed through an event
(b)
whether prior opportunities existed to identify the problem requiring
corrective action, and if so, the age and number of those opportunities
(c)
whether the problem was revealed as the result of a licensee
self-monitoring effort, such as conducting an audit, a test, a surveillance,
a design review, or troubleshooting
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NRC Enforcement Policy
2.
(d)
for a problem revealed through an event, the ease of discovery and the
degree of licensee initiative in identifying the root cause of the problem
and any associated violations
(e)
for NRC-identified issues, whether the licensee would likely have
identified the issue in the same time period if the NRC had not been
involved
(f)
for NRC-identified issues, whether the licensee should have identified the
issue (and taken action) earlier
(g)
for cases in which the NRC identified the overall problem requiring
corrective action (e.g., a programmatic issue), the degree of licensee
initiative or lack of initiative in identifying the problem or problems
requiring corrective action
Although some cases may consider all of the above factors, the importance of
each factor will vary based on the type of case, as discussed in the following
general guidance:
(a)
Licensee Identified—When a problem requiring corrective action is
licensee identified (i.e., identified by the licensee before the problem
results in an event), the NRC should normally give the licensee credit for
actions related to identification, regardless of whether prior opportunities
existed to identify the problem.
(b)
Identified through an Event—When a problem requiring corrective action
is identified through an event (i.e., the problem is self-revealing), the
decision as to whether to give the licensee credit for actions related to
identification normally should consider the ease of discovery, whether the
event occurred as the result of a licensee’s self-monitoring effort (i.e.,
whether the licensee was “looking for the problem”), the degree of
licensee initiative in identifying the problem or problems requiring
corrective action, and whether prior opportunities existed to identify the
problem.
Any of these considerations may be overriding if particularly noteworthy
or particularly egregious. For example, if the event occurred as the result
of conducting a surveillance or similar self-monitoring effort (i.e., the
licensee was looking for the problem), the licensee should normally be
given credit for identification. Even if the problem was easily discovered
(e.g., revealed by a large spill of liquid), the NRC may choose to give
credit because noteworthy licensee effort was exerted in discovering the
root cause and associated violations, or simply because no prior
opportunities, for example, procedural cautions, post-maintenance
testing, quality control failures, readily observable parameter trends, or
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NRC Enforcement Policy
(c)
repeated or locked-in annunciator warnings) existed to identify the
problem.
NRC Identified—When a problem requiring corrective action is NRC
identified, the decision as to whether to give the licensee credit for actions
related to identification should normally be based on an additional
question: should the licensee have reasonably identified the problem
(and taken action) earlier?
In most cases, this reasoning may be based simply on the ease of the
NRC inspector’s discovery (e.g., conducting a walkdown, observing in the
control room, performing a confirmatory NRC radiation survey, hearing a
cavitating pump, or finding a valve obviously out of position). In some
cases, the licensee’s missed opportunities to identify the problem may
include a similar previous violation, NRC or industry notices, internal
audits, or readily observable trends.
If the NRC identified the violation but concludes that, under the
circumstances, the licensee could not have reasonably identified the
problem earlier, the matter would be treated as licensee identified for
purposes of assessing the civil penalty.
(d)
Mixed Identification—For “mixed” identification situations (i.e., where
multiple violations exist, some identified by the NRC and some by the
licensee, or where the NRC prompted the licensee to take action that
resulted in the identification of the violation), the NRC’s evaluation should
normally determine whether the licensee could reasonably have been
expected to identify the violation in the NRC’s absence. This
determination should consider, among other things, the timing of the
NRC’s discovery, the information available to the licensee that caused the
NRC’s concern, the specificity of the NRC’s concern, the scope of the
licensee’s efforts, the level of licensee resources given to the
investigation, and whether the licensee had dismissed the NRC’s analysis
or was pursuing it in parallel.
In some cases, the licensee may have addressed the isolated symptoms
of each violation (and may have identified the violations), but failed to
recognize the common root cause and to take the necessary
comprehensive action. In this case, the decision as to whether to give the
licensee credit for actions related to identification should focus on
identification of the problem requiring corrective action (e.g., the
programmatic breakdown). As such, depending on the chronology of the
various violations, the earliest of the individual violations might be
considered missed opportunities for the licensee to have identified the
larger problem.
(e)
Missed Opportunities To Identify—Missed opportunities include prior
notifications or missed opportunities to identify or prevent violations such
as (1) through normal surveillances, audits, or QA activities, (2) through
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NRC Enforcement Policy
prior notice (i.e., specific NRC or industry notification), or (3) through
other reasonable indication of a potential problem or violation, such as
observations of employees and contractors, and failure to take effective
corrective steps. A missed opportunity may include findings of the NRC,
the licensee, or industry made at other facilities operated by the licensee
where it is reasonable to expect the licensee to act to identify or prevent
similar problems at the facility subject to the enforcement action at issue.
In assessing this factor, the NRC will consider, among other things, the
opportunities available to discover the violation, the ease of discovery, the
similarity between the violation and the notification, the period of time
between when the violation occurred and when the notification was
issued, the action taken (or planned) by the licensee in response to the
notification, and the level of management review that the notification
received (or should have received).
The evaluation of missed opportunities should normally depend on
whether the information available to the licensee should reasonably have
caused action that would have prevented the violation. A missed
opportunity to identify is normally not applied where the licensee
appropriately considered the information available to it and took, or
planned to take, reasonable action within a reasonable time.
In some situations, the missed opportunity is a violation in itself. In these
cases, unless the missed opportunity is a SL III violation in itself, the
missed opportunity violation may be grouped with the other violations into
a single SL III “problem.” However, if the missed opportunity is the only
violation, then it should not normally be counted twice (i.e., counting it as
both a violation and a missed opportunity constitutes “double counting”),
unless the number of opportunities missed was particularly significant.
The timing of the missed opportunity should also be considered. While a
rigid timeframe is unnecessary, for consistency in implementation,
2 years should generally be considered as the period reflecting relatively
current performance.
3.
c.
When the NRC determines that the licensee should receive credit for actions
related to identification, the civil penalty assessment should normally result in
either no civil penalty or a base civil penalty, depending on whether corrective
action is judged to be reasonably prompt and comprehensive. When the licensee
is not given credit for actions related to identification, the civil penalty assessment
should normally result in an NOV with either a base civil penalty or a base civil
penalty escalated by 100 percent, depending on the quality of corrective action.
Were the licensee’s corrective actions prompt and comprehensive?
The purpose of the corrective action factor is to encourage licensees to (1) take the
immediate actions necessary upon discovery of a violation that will restore safety,
security, and compliance with the license, regulation(s), or other requirement(s) and
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NRC Enforcement Policy
(2) develop and implement (in a timely manner) the lasting actions that will not only
prevent recurrence of the violation at issue, but will be appropriately comprehensive,
given the significance and complexity of the violation, to prevent occurrence of violations
with similar root causes.
Regardless of other circumstances (e.g., past enforcement history, identification), the
licensee’s corrective actions should always be evaluated as part of the civil penalty
assessment process. As a reflection of the importance given to this factor, an NRC
judgment that the licensee’s corrective action has not been prompt and comprehensive
will always result in the issuance of at least a base civil penalty.
In assessing this factor, the NRC will consider the timeliness of the corrective action
(including the promptness in developing the schedule for long-term corrective action),
the adequacy of the licensee’s root cause analysis for the violation, and, given the
significance and complexity of the issue, the comprehensiveness of the corrective action
(i.e., whether the action is focused narrowly on the specific violation or broadly on the
general area of concern).
Normally, the judgment of the adequacy of corrective actions will hinge on whether the
NRC had to act to focus the licensee’s evaluative and corrective process to obtain
comprehensive corrective action. This will normally be determined at the time of the
predecisional enforcement conference (e.g., by outlining substantive additional areas
where corrective action is needed). Earlier informal discussions between the licensee
and NRC inspectors or management may result in improved corrective action but should
not normally be a basis to deny credit for corrective action. For cases in which the
licensee does not receive credit for actions related to identification because the NRC
identified the problem, the assessment of the licensee’s corrective action should begin
from the time when the NRC put the licensee on notice of the problem. Notwithstanding
eventual effective comprehensive corrective action, if immediate corrective action was
not taken to restore safety and compliance once the violation was identified, corrective
action would not be considered prompt and comprehensive.
The NRC, in considering the comprehensiveness of the corrective action, will consider
whether the licensee applied the corrective actions to all its similarly licensed operations
that could be susceptible to the same failure (for those licensees having more than one
facility or location). When the NRC, at the time of the enforcement conference, identifies
additional peripheral or minor corrective action still to be taken, the licensee may be
given credit in this area, as long as the licensee’s actions addressed the underlying root
cause and are considered sufficient to prevent recurrence of the violation and similar
violations.
Corrective action for violations involving discrimination should normally be considered
comprehensive only if the licensee takes prompt, comprehensive corrective action that
(1) appropriately addresses the broader environment for raising safety concerns in the
workplace and (2) provides a remedy for the particular discrimination at issue.
If the corrective action is judged to be prompt and comprehensive, an NOV normally
should be issued with no associated civil penalty. If the corrective action is judged to be
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NRC Enforcement Policy
less than prompt and comprehensive, the NOV normally should be issued with a base
civil penalty.
In response to violations of 10 CFR 50.59, corrective action should normally be
considered prompt and comprehensive only if the licensee makes a prompt decision on
operability and does either of the following:
d.
1.
makes a prompt evaluation under 10 CFR 50.59 if it intends to maintain the
facility or procedure in the as-found condition
2.
promptly initiates corrective action consistent with Criterion XVI of
10 CFR Part 50, Appendix B, “Quality Assurance Criteria for Nuclear Power
Plants and Fuel Reprocessing Plants,” if it intends to restore the facility or
procedure to the final safety analysis report (FSAR) description
In view of the circumstances of the violation, should the NRC exercise enforcement
discretion to either escalate or mitigate the amount of the civil penalty?
As discussed in Section 3.6, “Use of Discretion in Determining the Amount of a Civil
Penalty,” discretion may be exercised by either escalating or mitigating the amount of
the civil penalty determined after applying the civil penalty adjustment factors to ensure
that the proposed civil penalty reflects all relevant circumstances of the particular case.
However, in no instance will a civil penalty for any one violation exceed the statutory
daily limit.
2.3.5
Orders
An Order is a written NRC directive to modify, suspend, or revoke a license; to cease and desist
from a given practice or activity; or to take such other action as may be proper (see
10 CFR 2.202, “Orders”). Orders may be issued in lieu of, or in addition to, civil penalties, as
appropriate, for SL I, II, and III violations. Unless a separate response is warranted pursuant to
10 CFR 2.201, the NRC does not need to issue an NOV in addition to the Order when the NOV
is based on violations described in the Order. Orders may be made immediately effective,
without prior opportunity for a hearing, whenever the NRC determines that the public health,
safety, interest, or common defense and security so requires, or if the violation or conduct
causing the violation is willful. In such cases, the Order may provide, for stated reasons, that
the proposed action be immediately effective pending further action. Otherwise, the Agency
grants a prior opportunity for a hearing on the Order.
The NRC may also issue Orders to nonlicensees, including contractors and subcontractors,
holders of NRC approvals (e.g., certificates of compliance, early site permits, standard design
certifications, or applicants for any such approvals), and to employees of any of the foregoing
and to licensed individuals, such as licensed reactor operators, and nonlicensed individuals.
A more detailed discussion of Orders is available in the Enforcement Manual.
2.3.6
Demand for Information
The Commission may also issue a demand for information (DFI) (see 10 CFR 2.204, “Demand
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NRC Enforcement Policy
for Information”) to determine whether an Order under 10 CFR 2.202 should be issued or
whether other action should be taken.
2.3.7 Administrative Actions
The NRC also uses administrative actions, such as confirmatory action letters, notices of
deviation, and notices of nonconformance, to supplement its enforcement program. These
administrative actions are explained in the Enforcement Manual and defined in the glossary of
this Policy. The NRC expects licensees and other persons subject to the Commission’s
jurisdiction to adhere to any obligations and commitments resulting from administrative actions
and will consider issuing additional Orders, as needed, to ensure compliance.
2.3.8
Reopening Closed Enforcement Actions
Under special circumstances (e.g., when the NRC receives significant new information
indicating that an enforcement sanction was incorrectly applied), the Agency may consider, on a
case-by-case basis, reopening a closed enforcement action to increase or decrease the severity
of a sanction or to correct the record.
Special circumstances include but are not limited to (1) a situation where persons provided
incomplete or inaccurate information that would have been considered material to the NRC’s
disposition of a case, (2) information was deliberately withheld or obscured, or (3) the licensee
made errors in calculations that would not have normally been reviewed by the NRC. Special
circumstances do not normally include the discovery of additional information that was
reasonably available to the NRC at the time the Agency made its initial enforcement decision
unless the Commission determines that action is necessary to ensure that the facility provides
adequate protection to the health and safety of the public and is in accord with the common
defense and security.
2.3.9
Enforcement Guidance Memoranda
Enforcement guidance memoranda (EGM) are used to provide the NRC staff with temporary
enforcement guidance, including, in some instances, enforcement discretion, when the criteria
specified in the EGM are met. EGM normally describe the situation that has occurred that
requires the use of such guidance, as well as the length of time the EGM will be in effect. For a
list of current EGM, see Appendix A of the NRC Enforcement Manual.
2.3.10 Commission Notification and Consultation on Enforcement Actions
Certain enforcement actions require either advance written notification to the Commission or
advance consultation with and approval by the Commission depending on the nature of the
proposed sanction. Specific enforcement actions requiring prior Commission notification and
consultation include, but are not limited to, the following:
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NRC Enforcement Policy
a.
b.
Enforcement Actions Requiring Written Notification to the Commission:
1.
all enforcement actions involving civil penalties or Orders
2.
all notices of enforcement discretion involving natural events, such as severe
weather conditions
3.
the first time that discretion is exercised for a plant that meets the criteria of
Section 3.1, “Violations Identified during Extended Shutdowns or Work
Stoppages”
4.
where appropriate, based on the uniqueness or significance of the issue, when
discretion is exercised for violations that meet the criteria of Section 3.5,
“Violations Involving Special Circumstances”
Enforcement Actions Requiring Advance Consultation with the Commission:
1.
an action affecting a licensee’s operation that requires balancing the public
health and safety or common defense and security implications of not operating
against the potential radiological or other hazards associated with continued
operation
2.
proposals to impose a civil penalty for a single violation or problem that is greater
than 3 times the Severity Level I value shown in Table A of Section 8.0 for that
class of licensee
3.
any proposed enforcement action that involves a SL I violation
4.
any action that the EDO believes warrants Commission involvement
5.
any proposed enforcement case involving an Office of Investigations (OI) report
where the NRC staff (other than the OI staff) does not arrive at the same
conclusions as those in the OI report concerning issues of intent if the Director,
OI, concludes that Commission consultation is warranted
6.
any proposed enforcement action on which the Commission asks to be consulted
7.
any proposals to use discretion to impose a daily civil penalty
2.3.11 Inaccurate and Incomplete Information
A violation of the regulations involving the submittal of incomplete or inaccurate information can
result in the full range of enforcement sanctions. The labeling of a communication failure as a
material false statement will be made on a case-by-case basis and will be reserved for
egregious violations. Violations involving inaccurate or incomplete information or the failure to
provide significant information identified by a licensee or applicant normally will be categorized
based on the guidance herein, in Section 2.2, “Assessment of Violations,” and in Section 6.9,
“Inaccurate and Incomplete Information or Failure To Make a Required Report.”
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The Commission recognizes that oral information may in some situations be inherently less
reliable than written submittals because of the absence of an opportunity for reflection and
management review. However, the Commission must be able to rely on oral communications
from a licensee or applicant official concerning significant information. Therefore, in determining
whether to take enforcement action for an oral statement, the Commission may consider factors
such as (1) the degree of knowledge that the communicator should have had regarding the
matter, in view of his or her position, training, and experience, (2) the opportunity and time
available before the communication to ensure the accuracy or completeness of the information,
(3) the degree of intent or negligence, if any, involved, (4) the formality of the communication,
(5) the reasonableness of NRC reliance on the information, (6) the importance of the information
that was inaccurate or not provided, and (7) the reasonableness of the explanation for not
providing complete and accurate information.
In the absence of at least careless disregard, an incomplete or inaccurate unsworn oral
statement normally will not be subject to enforcement action unless it involves significant
information provided by a licensee or applicant official (e.g., information to support a Notice of
Enforcement Discretion). However, enforcement action may be taken for an unintentionally
incomplete or inaccurate oral statement provided to the NRC by a licensee or applicant official
or others on behalf of a licensee or applicant, if a record was made of the oral information and
provided to the licensee or applicant, thereby permitting an opportunity to correct the oral
information. An example of such a situation would be a case in which the licensee or applicant
had available a transcript of the communication or meeting summary containing the error and
did not subsequently correct the error in a timely manner.
When a licensee or applicant has corrected inaccurate or incomplete information, the decision
to issue an enforcement action for the initial inaccurate or incomplete information normally will
depend on the circumstances, including the ease of detection of the error, the timeliness of the
correction, whether the NRC or the licensee or applicant identified the problem with the
communication, and whether the NRC relied on the information prior to the correction.
Generally, if the matter was promptly identified and corrected by the licensee or applicant before
the NRC relies on the information, or before the NRC raises a question about the information,
no enforcement action will be taken for the initial inaccurate or incomplete information. On the
other hand, if the misinformation is identified after the NRC relies on it, or after some question is
raised regarding the accuracy of the information, then some enforcement action normally will be
taken even if the information is corrected. However, if the initial submittal was accurate when
made but later turns out to be erroneous because of newly discovered information or an
advance in technology, a citation normally would not be appropriate if, when the new
information became available or the advance in technology was made, the initial submittal was
corrected. The failure to correct inaccurate or incomplete information that the licensee or
applicant does not identify as significant normally will not constitute a separate violation.
However, the circumstances surrounding the failure to correct may be considered relevant to
the determination of enforcement action for the initial inaccurate or incomplete statement. For
example, an unintentionally inaccurate or incomplete submission may be treated as a more
severe matter if the licensee or applicant later determines that the initial submittal was in error
and does not correct it, or if there were clear opportunities to identify the error. If a licensee or
applicant recognizes that information not corrected is significant, a separate citation may be
made for the failure to provide significant information. In any event, in serious cases where the
licensee’s or applicant’s actions in not correcting or providing information raise questions about
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NRC Enforcement Policy
the licensee’s or applicant’s commitment to safety or its fundamental trustworthiness, the
Commission may exercise its authority to issue orders modifying, suspending, or revoking the
license. Enforcement determinations are made on a case-by-case basis, taking into
consideration the issues described in this section.
2.3.12 Reporting of Defects and Noncompliance
Licensees and entities that supply products or services for use in nuclear activities are subject
to certain requirements designed to ensure that products or services that could affect safety
meet regulatory standards. Through procurement contracts with licensees or their contractors,
suppliers may be required to have quality assurance programs that meet applicable quality
assurance requirements (e.g., 10 CFR Part 50, “Domestic Licensing of Production and
Utilization Facilities,” Appendix B, “Quality Assurance Criteria for Nuclear Power Plants and Fuel
Reprocessing Plants,” or 10 CFR Part 71, “Packaging and Transportation of Radioactive
Material,” Subpart H, “Quality Assurance”). Contractors supplying basic components or
services to licensees or their contractors are subject to the requirements of 10 CFR Part 21,
“Reporting of Defects and Noncompliances,” for reporting defects and failures to comply
associated with a substantial safety hazard. Contractors constructing or modifying 10 CFR Part
50 construction permit holder or 52 licensee facilities, up to the 52.103(g) finding, are subject to
the additional requirements of 10 CFR 50.55(e) for reporting of defects and failures to comply
associated with a substantial safety hazard, and any significant breakdown in the quality
assurance program that could cause a defect in basic components when contractually imposed.
When inspectors determine that violations of NRC requirements (e.g., 10 CFR Part 50,
Appendix B) have occurred that could adversely affect the quality of a safety-significant product
or service, the NRC will typically take enforcement action. NOVs and civil penalties will be
used, as appropriate, for licensee failures to ensure that their contractors have programs that
meet applicable requirements. The NRC may also issue NOVs to contractors and vendors who
violate 10 CFR Part 21 and may also issue NOVs for other violations such as those resulting
from deliberate misconduct. Civil penalties may be imposed against individual directors or
responsible officers of a contractor organization who deliberately fail to provide the notice
required by 10 CFR 21.21(d)(1). The NRC may issue NOVs or orders to nonlicensees who are
subject to the specific requirements of 10 CFR Part 71 and 10 CFR Part 72, “Licensing
Requirements for the Independent Storage of Spent Nuclear Fuel, High-Level Radioactive
Waste, and Reactor-Related Greater than Class C Waste.” Notices of Nonconformance will be
used for contractors who fail to meet commitments related to NRC activities but are not in
violation of specific requirements.
2.4
Participation in the Enforcement Process
Before making a final enforcement decision in cases where the NRC is considering taking
escalated enforcement action (i.e., a SL III or higher NOV or a greater-than-green ROP finding),
the NRC will typically offer the organization or individual subject to the enforcement action a
conference with the NRC to present facts relevant to the assessment and disposition of the
apparent violations. The NRC may also request a conference if additional information is needed
to make a determination relevant to the assessment and disposition of the apparent violations
(e.g., whether violations occurred, the severity level of the violations, willfulness of any
violations, and whether credit should be given for corrective actions or self-identification). The
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NRC Enforcement Policy
conference is normally held at an NRC regional office and is normally open to public
observation except when the proposed enforcement action involves discussions of classified or
Safeguards Information, an enforcement action against an individual, proprietary information, or
other sensitive, nonpublic information. In addition, licensees, nonlicensees, and individuals can
be offered ADR (see Section 2.4.3, “Alternative Dispute Resolution”).
2.4.1
Predecisional Enforcement Conference
A predecisional enforcement conference (PEC) is a conference held with a licensee for
violations assessed using traditional enforcement. (The term “licensee,” as used in Section
2.4.1, is applied broadly and includes NRC licensees, applicants, licensed and nonlicensed
individuals, contractors, vendors, and other persons.) The purpose of the PEC is to obtain
information from the licensee to assist the NRC in determining whether an enforcement action is
necessary and, if so, what the appropriate enforcement action is. The PEC focuses on areas
such as (1) a common understanding of the facts, root causes, and missed opportunities
associated with the apparent violation and (2) a common understanding of the corrective actions
taken or planned. If held, a PEC is normally the final step in the NRC’s fact-finding process
before making an enforcement decision.
When the NRC determines that there is a violation for which escalated enforcement action
appears warranted, the Agency normally offers the licensee the opportunity to attend a PEC or
provide a written response to the apparent violation, or both, before the NRC makes an
enforcement decision. If the NRC concludes that it has sufficient information to make an
informed enforcement decision involving a licensee, the NRC will notify the licensee that a PEC
does not appear to be necessary, and unless the licensee specifically requests a PEC, one will
not be held. The NRC may specifically request a PEC if it needs additional information before
making a final enforcement decision. If the NRC does not request a PEC or if the licensee does
not accept the NRC’s offer to attend a PEC, the licensee may choose to respond in writing to a
documented apparent violation (including its root causes and a description of planned or
implemented corrective actions) before the NRC takes enforcement action. To the extent
practicable, the NRC will consider the licensee’s response before taking enforcement action.
A more detailed discussion of PECs is available in the Enforcement Manual.
2.4.2
Regulatory Conference
A regulatory conference is conducted, in lieu of a PEC, for power reactor inspection findings
assessed using the SDP. For reactor inspection findings that are preliminarily assessed as
greater than green, the licensee will normally be given an opportunity to meet with the NRC to
exchange information related to that assessment. Because the significance assessment
typically requires a determination as to whether violations occurred, a subsequent PEC is not
normally required.
2.4.3
Alternative Dispute Resolution
The Administrative Dispute Resolution Act of 1996 (ADRA) authorizes and encourages the use
of ADR by Federal agencies. ADR refers to a variety of processes that emphasize creative,
cooperative approaches to handling conflicts in lieu of adversarial procedures. Mediation is the
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NRC Enforcement Policy
form of ADR typically used by the NRC. The use of ADR in the NRC’s enforcement program is
available for cases involving discrimination and other wrongdoing cases (which in some
wrongdoing cases also include any nonwillful violation identified during an OI investigation) after
the NRC OI has completed an investigation (i.e., postinvestigation ADR), and the NRC
concludes that pursuit of an enforcement action appears warranted. Post-investigation ADR
may also be used for discrimination violations based solely on a finding by DOL; however, the
NRC will not negotiate the DOL finding. Individuals within the Commission’s jurisdiction may
also be offered ADR. Post-investigation ADR complements, and works in conjunction with, the
traditional NRC enforcement process. ADR may be offered (1) before a PEC, (2) after the
initial enforcement action is taken (i.e., an NOV or proposed imposition of a civil penalty), or
(3) with the imposition of a civil penalty and prior to a hearing request. Use of the postinvestigation ADR program is voluntary for all parties, including the NRC; any participant may
end the process at any time. Mediation activities are kept confidential in accordance with
5 U.S.C. § 574; however, the terms of the settlement agreement are normally formalized in a
Confirmatory Order, which is published in the Federal Register. Normally, there is also a press
release providing information about the settlement agreement.
In some circumstances, it may not be appropriate for the NRC to engage in post-investigation
ADR (e.g., the U.S. Department of Justice has substantial involvement in the case, cases in
which the subject matter is such that a Confirmatory Order detailing the terms of a settlement
agreement cannot be made public, or other particularly egregious cases in which the public
interest is not served by engaging in ADR). The approval of the Director, OE, is required in
those cases where the staff proposes not to offer post-investigation ADR.
Additional information concerning the NRC’s post-investigation ADR program is available in the
NRC Enforcement Manual and on the NRC Web site.
In addition, an individual and his or her employer (or former employer) can use ADR to resolve
discrimination complaints (under Section 211 of the ERA) before the initiation of investigative
activities by OI (i.e., pre-investigation ADR, commonly referred to as “early ADR”) (see NRC
Management Directive 8.8, “Management of Allegations”) or a licensee-sponsored ADR
program that is similar in nature to the NRC’s early ADR program. If the parties reach a
settlement agreement using early ADR or licensee-sponsored ADR, the NRC subsequently
reviews the agreement to ensure that it does not include any provisions in violation of the NRC’s
“Employee Protection” regulations. If no such restrictive provisions exist, the NRC will not
investigate the discrimination complaint or take enforcement action.
3.0
USE OF ENFORCEMENT DISCRETION
The NRC may choose to exercise discretion and either escalate or mitigate enforcement
sanctions or otherwise refrain from taking enforcement action within the Commission’s statutory
authority. The exercise of discretion allows the NRC to determine what actions should be taken
in a particular case, notwithstanding the guidance contained in this statement of policy. After
considering the general tenets of this Policy and the safety and security significance of a
violation and its surrounding circumstances, judgment and discretion may be exercised in
determining the severity levels of violations and the appropriate enforcement sanctions to be
taken.
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3.1
Violations Identified during Extended Shutdowns or Work Stoppages
Notwithstanding the outcome of the normal NOV and civil penalty assessment processes, the
NRC may reduce or refrain from issuing an NOV or a proposed civil penalty for a SL II, III, or IV
violation that is identified after one of the following:
a.
The NRC has taken significant enforcement action based on a major safety event
contributing to an extended shutdown of an operating nuclear reactor or a material
licensee (or a work stoppage at a construction site).
b.
The licensee enters an extended shutdown or work stoppage related to generally poor
performance over a long period of time, provided that the violation is documented in an
inspection report (or inspection records for some materials cases) and meets all of the
following criteria:
1.
The violation was either identified by the licensee as a result of a comprehensive
program for violation identification and correction developed in response to the
shutdown or work stoppage or identified as a result of an employee or contractor
concern identified to the licensee through its internal processes.
2.
The violation was based on activities of the licensee before the events leading to
the shutdown.
3.
The violation would not be categorized at SL I.
4.
The violation was not willful.
5.
The licensee’s decision to restart the plant from the shutdown or work stoppage
requires NRC coordination and/or action.
c.
Notwithstanding the discretion criterion described above in 3.1.b.4, enforcement
discretion for violations involving willfulness may still be appropriate under the
specific circumstances of a case. However, the Director, OE, must approve the
exercise of such discretion when a willful violation is involved.
3.2
Violations Involving Old Design Issues
For operating facilities, the NRC may exercise discretion to refrain from proposing a civil penalty
for a SL II or III violation involving a past problem, such as in engineering, design, or installation,
if the violation is documented in an inspection report (or inspection records for some material
cases) that describes the corrective action and it meets all of the following criteria:
a.
It was identified by the licensee as a result of a voluntary initiative.
b.
It was or will be corrected, including immediate corrective action and long-term
comprehensive corrective action to prevent recurrence, within a reasonable time
following identification (this action should involve expanding the initiative, as necessary,
to identify other failures caused by similar root causes).
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NRC Enforcement Policy
c.
It was unlikely to be identified (after the violation occurred) by efforts such as normal
surveillances or routinely scheduled QA activities.
In addition, the NRC may refrain from issuing an NOV for a SL II, III, or IV violation that meets
the above criteria, provided that the violation was caused by conduct that is not reasonably
linked to the licensee’s present performance (normally, violations that are at least 3 years old or
violations occurring during plant construction) and that there had not been prior notice so that
the licensee could not have reasonably identified the violation earlier. This exercise of
discretion is to encourage licensees to initiate efforts to identify and correct subtle violations that
are not likely to be identified by routine efforts before degraded safety systems are called on to
work.
3.3
Violations Identified Because of Previous Enforcement Action
The NRC may refrain from issuing an NOV or a proposed civil penalty for a SL II, III, or IV
violation that is identified after the NRC has taken enforcement action, if the violation is
identified by the licensee as part of the corrective action for the previous enforcement action and
the violation has the same or similar root cause as the violation for which enforcement action
was previously taken. Additionally, the new example must not substantially change the safety
significance or the character of the regulatory concern arising out of the initial violation and must
be corrected, including immediate corrective action and long-term comprehensive corrective
action to prevent recurrence, within a reasonable time following identification.
3.4
Violations Involving Certain Discrimination Issues
For violations of the NRC’s employee protection regulations (e.g., 10 CFR 30.7, 50.7 and
10 CFR 52.5), the NRC may exercise discretion to mitigate enforcement sanctions and refrain
from issuing a civil penalty or an NOV, or both, when a licensee who, without the need for
Government intervention, identifies an issue of discrimination and takes prompt,
comprehensive, and effective corrective action to address both the particular situation and, if
required, the overall work environment for raising safety concerns.
Similarly, the NRC may exercise discretion when a licensee settles a complaint filed with DOL
under Section 211 of the ERA before DOL makes an initial finding of discrimination and, as
necessary, addresses the overall work environment. Alternatively, if DOL makes a finding of
discrimination, the licensee may choose to settle the case before the evidentiary hearing begins.
In such cases, the NRC may exercise its discretion not to take enforcement action when the
licensee has addressed the overall work environment for raising safety concerns and has
publicized that a complaint of discrimination for engaging in protected activity was made to DOL,
that the matter was settled to the satisfaction of the employee, and that, if the DOL area office
found discrimination, the licensee has acted to positively reemphasize that discrimination will
not be tolerated.
After the initiation of an OI investigation and subsequent substantiation of the discrimination
complaint, the NRC may also exercise discretion (i.e., mitigate enforcement sanctions) in
discrimination cases in which a licensee settles a matter promptly after a person comes to the
NRC without going to DOL. The NRC would normally not exercise such discretion in cases in
which the licensee does not appropriately address the overall work environment or in cases that
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NRC Enforcement Policy
involve the following: allegations of discrimination as a result of providing information directly to
the NRC, allegations of discrimination caused by a manager above first-line supervisor,
allegations of discrimination where a history of findings of discrimination (by DOL or the NRC) or
settlements suggests a programmatic rather than an isolated discrimination problem, or
allegations of discrimination that appear particularly blatant or egregious.
3.5
Violations Involving Special Circumstances
Notwithstanding the outcome of the normal enforcement process, the NRC may reduce or
refrain from issuing a civil penalty or an NOV for a SL II, III, or IV violation based on the merits
of the case after considering the guidance in this statement of policy and such factors as the
age of the violation, the significance of the violation, the clarity of the requirement and
associated guidance, the appropriateness of the requirement, the overall sustained performance
of the licensee, and other relevant circumstances, including any that may have changed since
the violation occurred. This discretion is expected to be exercised only where application of the
normal guidance in the Policy is unwarranted. In addition, the NRC may refrain from issuing
enforcement action for violations resulting from matters not within a licensee’s control, such as
equipment failures that were not avoidable by reasonable licensee QA measures or
management controls. Generally, however, licensees are held responsible for the acts of their
employees and contractors. Accordingly, this Policy should not be construed to excuse
personnel or contractor errors.
3.6
Use of Discretion in Determining the Amount of a Civil Penalty
Notwithstanding the outcome of the normal civil penalty assessment process addressed in
Section 2.3.4, “Civil Penalty”, the NRC may exercise discretion5 by either proposing a civil
penalty where application of the civil penalty assessment factors would otherwise result in zero
penalty or by escalating the amount of the resulting civil penalty to ensure that the proposed civil
penalty appropriately reflects the significance of the issue. In accordance with Section 2.3.10,
“Commission Notification and Consultation on Enforcement Actions”, of this Policy, the
Commission must be notified of all enforcement actions involving civil penalties and must be
consulted for any proposed civil penalty for a single violation or problem that is greater than 3
times the value in Tables A and B in Section 8.0 for the severity level violation being considered.
Civil penalty discretion should be considered for, but is not limited to, the following:
a.
violations or problems originally categorized at a SL I or II
b.
overexposures or the release of licensed material in excess of NRC limits
c.
particularly poor licensee performance
d.
situations when the licensee’s previous enforcement history has been particularly poor,
or when the current violation directly repeats an earlier violation
5
In the context of Section 3.6, “discretion” refers to the escalation or mitigation of an enforcement action or
sanction. This differs from the typical use of the term “discretion” to indicate the NRC’s choice to mitigate or not take
enforcement action for an issue.
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NRC Enforcement Policy
e.
willfulness, particularly instances where the licensee made a conscious
decision to be in noncompliance with NRC requirements in order to obtain
an economic benefit
f.
situations where the violation resulted in a substantial increase in risk, including cases in
which the duration of the violation has contributed to the substantial increase in risk
g.
violations involving a Master Materials Licensee (MML)—Discretion not to issue a civil
penalty may be used in cases where the MML’s oversight program resolved the issue
appropriately. In recognition of the scope, level of responsibility, and independence
entrusted to MMLs, the NRC may use discretion to increase a civil penalty by multiples
of the normal base civil penalty. This increase would normally be applied in cases
where a programmatic failure occurred in the MML’s oversight program.
h.
loss of control of regulated material
3.7
Exercise of Discretion to Issue Orders
The NRC may exercise discretion, where necessary or desirable, by issuing Orders with or in
lieu of civil penalties to achieve or formalize corrective actions and to deter further recurrence of
serious violations.
3.8
Notices of Enforcement Discretion for Operating Power Reactors and Gaseous
Diffusion Plants6
The NRC may choose not to enforce the applicable technical specification (TS) limiting
condition for operation (LCO) or other license conditions, in circumstances where compliance
would involve an unnecessary plant transient or the performance of a test, inspection, or system
realignment that may not be the most prudent action to take under the specific plant conditions,
or unnecessary delays in plant startup, without a corresponding health and safety benefit.
Similarly, for example, for a gaseous diffusion plant, circumstances may arise where compliance
with a technical safety requirement or TS or other certificate condition would unnecessarily call
for a total plant shutdown or, notwithstanding that a safety, safeguards, or security feature was
degraded or inoperable, compliance would unnecessarily place the plant in a transient or
condition where those features could be required.
The NRC will issue a notice of enforcement discretion (NOED) only if the staff is clearly satisfied
that the action is consistent with protecting the public health and safety or security. The NRC
staff may also grant enforcement discretion in cases involving severe weather or other natural
phenomena, based upon balancing the public health and safety or common defense and
security of not operating against the potential radiological or other hazards associated with
continued operation, and a determination that safety will not be impacted unacceptably by
exercising this discretion. The staff shall inform the Commission expeditiously following the
granting of a NOED in these situations.
6
NOEDs will not be used at reactors during construction before the Commission’s 10 CFR 52.103(g) or
10 CFR 50.57 finding, as applicable. However, the NRC may choose to exercise discretion and either
escalate or mitigate enforcement sanctions or otherwise refrain from taking enforcement action within the
Commission’s statutory authority, as identified in Section 3.0 of this Enforcement Policy.
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NRC Enforcement Policy
Issuance of an NOED does not change the fact that a violation will occur, nor does it imply that
enforcement discretion is being exercised for any violation that may have led to the violation at
issue. In each case where the NRC has chosen to issue an NOED, enforcement action will
normally be taken for the root causes, to the extent violations were involved, that led to the
noncompliance for which enforcement discretion was used.
Additional guidance on the process for issuing an NOED is found on the NRC’s web site.
3.9
Violations Involving Certain Construction Issues
a.
Fuel Cycle Facilities
The NRC may choose to exercise discretion for fuel cycle facilities under construction
(construction is defined in 10 CFR 40.4 for source material licensees and in 10 CFR 70.4
for special nuclear material licensees) based on the general enforcement discretion
guidance contained in Section 3 of this Enforcement Policy.
b.
Part 50 Construction Permit and LWA Holders
The NRC may exercise discretion for Construction Permit and LWA holders during
construction using the general enforcement discretion guidance in Section 3 of the
Enforcement Policy.
c.
COL Holders (Reactor Facilities)
The NRC may exercise discretion for COL holders during construction using the general
enforcement discretion guidance in Section 3 of the Enforcement Policy, as applicable.
Additionally, the NRC may reduce or refrain from issuing an NOV/NCV for a violation associated
with an unplanned change that deviates from the licensing basis that is implemented during
construction7 and that would otherwise require prior NRC approval (in the form of a license
amendment) when all of the following criteria are met:
•
The licensee identifies the unplanned changes implemented, which the staff
would normally disposition as a Severity Level IV violation of NRC
requirements8,
•
The licensee submits the necessary information without delay to the NRC so
that it can conduct a timely evaluation of the change as part of the license
amendment review process, or submits information to the NRC stating that it
will restore the current licensing basis.
7
The NRC may issue an enforcement action, including consideration of willfulness, for the cause of these
unplanned changes, such as a failure to implement appropriate work controls or quality control measures,
or a failure to adhere to procedures, processes, instructions, or standards that implement NRC
requirements. This enforcement may be appropriate for the actions that led to the CdC issue.
8
NRC-identified violations that result in a “use as built” determination or that result in an unplanned
change (or both) will normally be dispositioned as a cited, noncited, or minor violation, whether or not the
unplanned change issue is resolved by a subsequently approved license amendment.
34
NRC Enforcement Policy
•
Either (1) the cause of the deviation was not within the licensee’s control,
such that the change was not avoidable by reasonable licensee quality
assurance measures or management controls, or (2) the licensee placed the
cause of the unplanned change in its corrective action program to ensure
comprehensive corrective actions to address the cause of the change to
preclude recurrence.
For similar issues not identified by the licensee, the NRC may refrain from issuing an NOV/NCV
on a case-by-case basis depending upon the circumstances of the issue, such as whether the
requirements were clearly understood or should have been understood at the time, the cause of
the issue, and why the licensee did not identify the issue.
When the NRC determines that an unplanned change during construction associated with a
violation of requirements meets the outlined criteria above and the licensee without delay
submits the necessary information for NRC evaluation, the licensee’s continued failure to meet
the current licensing basis will not be treated as a willful or continuing violation only while the
licensee prepares the license amendment request and the NRC reviews the submittal. (Note: If
the NRC subsequently denies a requested license amendment change, or if the NRC requires
additional measures to be taken for the change to be considered acceptable, then a separate
NOV or order may be issued to ensure appropriate corrective actions are taken, including
restoring the configuration to the CLB).
4.0
ENFORCEMENT ACTIONS INVOLVING INDIVIDUALS
Any individual may be subject to NRC enforcement action if the individual (1) deliberately
causes or would have caused, if not detected, a licensee to be in violation of any, regulation, or
Order, or any term, condition, or limitation of any license issued by the Commission related to
NRC-licensed activities or (2) deliberately submits materially inaccurate or incomplete
information to the NRC, a licensee, an applicant or a licensee, or a contractor or subcontractor
of a licensee or applicant for a license (e.g., see “Deliberate Misconduct” regulations in
10 CFR 30.10, 10 CFR 50.5, 10 CFR 52.4, and 10 CFR 76.10).
The Agency will normally take enforcement actions against nonlicensed individuals only in
cases involving deliberate misconduct by the nonlicensed individual, in cases involving a lack of
reasonable assurance, as discussed below in Section 4.2,” Notices of Violation and Orders to
Individuals,” and in cases in which an individual violates any requirement directly imposed on
him or her (e.g., a violation of any rule adopted under Section 147, “Safeguards Information,” of
the AEA). However, the NRC may take enforcement action against NRC-licensed reactor
operators even if the violation does not involve deliberate misconduct, since operators licensed
by the NRC are subject to all applicable Commission requirements (see 10 CFR 55.53(d)).
The NRC considers enforcement actions against individuals to be significant actions that will be
closely evaluated and judiciously applied. Typically, the NRC will take an enforcement action
involving an individual, either licensed or nonlicensed, only when the violation has actual or
potential safety or security significance. NOVs and Orders are examples of enforcement actions
that may be issued to individuals. Enforcement actions issued to individuals will normally be
placed on the NRC OE Web site. Generally, before taking enforcement action against an
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NRC Enforcement Policy
individual, the NRC will seek to gather information to determine whether an Order or other
enforcement action should be issued. The Agency may gather such information by conducting
a PEC, by requesting a written response from the individual, or by issuing a Demand for
Information. If the violation was deliberate, the individual may also be provided the opportunity
to address the apparent violation during ADR. The exact nature of the opportunity to address
the apparent violation will depend on the circumstances of the case, including the significance of
the issue, the enforcement sanction that the NRC is contemplating, and whether the individual
has already had an opportunity to respond to the apparent violation.
If the NRC discovers (through inspections or investigation-related material) potentially damaging
or disqualifying information regarding an individual’s trustworthiness and reliability, and the
individual currently possesses Unescorted Access (UA) or is in the process of obtaining
Unescorted Access Authorization (UAA), the NRC will consider, on a case-by-case basis,
notifying the licensee that has granted, or is processing the UA or UAA of the information. This
notification may occur in the preliminary or final determination stage of the enforcement
process, as appropriate, with approval of the Director, OE. The NRC will strongly consider the
degree of certainty associated with the information in making this decision. If the NRC makes
such a notification, it nevertheless remains the licensee’s responsibility to evaluate the
information provided in accordance with its access authorization program to determine the
appropriate actions regarding individual access authorizations. A licensee may reasonably
reach a conclusion that the information provided by the NRC is not disqualifying under the
circumstances (e.g., based on additional facts, based on a different assessment of the facts, or
based upon the final resolution of the enforcement process).
Since it is NRC policy to hold licensees responsible for the acts of their employees and
contractors, in most cases, the NRC will cite the licensee for violations committed by their
employees and contractors. Violations with a significance that would typically warrant escalated
enforcement action against the licensee may warrant an enforcement action against an
individual (e.g., deliberately providing inaccurate or incomplete information or deliberate
falsification of documents). Typically, the NRC will not take enforcement action against the
employee or contractor if failures of licensee management (e.g., improper training or inadequate
procedures) are responsible for the individual’s improper actions. In deciding whether to issue
enforcement actions both to a licensee and a nonlicensed individual, the NRC will make
decisions on a case-by-case basis.
4.1
Considerations in Determining Enforcement Actions Involving Individuals
The NRC recognizes that decisions regarding enforcement actions against individuals will have
to be made on a case-by-case basis. The NRC may propose an enforcement action or refrain
from taking an enforcement action after considering all the relevant circumstances of each case.
The primary factors considered by the NRC in considering whether to take action or what action
to take are (1) the significance of the underlying violation or technical issue (not considered in
discrimination cases) and (2) the individual’s position within the organization (i.e.,
notwithstanding an individual’s job title, consider the position of the individual within the
licensee’s organizational structure and the individual’s responsibilities related to the oversight of
licensed activities and to the use of licensed material).
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Other factors include, but are not limited to, whether the violation was the result of deliberate
misconduct (typically a prerequisite for taking action against a nonlicensed individual), the
benefit to the wrongdoer (e.g., direct personal or corporate gain), the degree of management
responsibility or culpability, and the attitude of the wrongdoer (e.g., admission of wrongdoing,
acceptance of responsibility).
4.2
Notices of Violation and Orders to Individuals
Although the NRC has the authority to issue NOVs to any individual who holds an NRC license
and violates NRC requirements, regardless of whether willfulness, either deliberate misconduct
or careless disregard, was involved, actions against licensed individuals for nonwillful violations
are rare. In the case of a licensed operator’s failure to meet applicable fitness-for-duty
requirements (i.e., 10 CFR 55.53(j)), the NRC may issue an NOV to the individual, or an Order
to suspend, modify, or revoke the individual’s 10 CFR Part 55 operator’s license. The Agency
may also issue to licensed individuals Orders containing provisions that would modify or revoke
the individual’s license or prohibit involvement in NRC-licensed activities for a specified period
of time (normally the period of suspension would not exceed 5 years) or until certain conditions
are satisfied (e.g., completing specified training or meeting certain qualifications).
The Commission may also take enforcement action (e.g., an Order or NOV) against
nonlicensed individuals, including contractors and subcontractors and their employees, who
knowingly provide components, equipment, or other goods or services that relate to a licensee’s
activities subject to NRC regulations. However, the NRC will not normally issue an enforcement
action against a nonlicensed individual unless the individual’s actions were a result of deliberate
misconduct. When needed to ensure adequate protection of public health and safety and the
common defense and security or the public interest, the NRC may issue an Order to an
unlicensed person, whether a firm or an individual, requiring (1) the removal of the person from
all NRC-licensed activities for a specified period of time (normally, the period of suspension
would not exceed 5 years) and (2) prior notice to the NRC before engaging in NRC-licensed
activities. In addition, Orders to employers who are NRC licensees could require retraining,
additional oversight, independent verification of activities performed by the individual, if the
individual is to be involved in licensed activities, and to inform other persons or NRC licensees
who make reference inquiries (e.g., employment reference inquiries) regarding the nonlicensed
individual or firm, of the issuance of such an Order.
For either a licensed or nonlicensed individual, the initial determination of a period of prohibition
from NRC-licensed activities is normally based on the significance of the underlying violation
and the individual’s level of responsibility within the organization. A high level of significance
combined with a high degree of responsibility results in initially considering a 5-year prohibition
period. Depending on the circumstances of the case, the NRC may consider either escalation
(including a permanent ban from NRC-licensed activities in significant cases) or mitigation of the
prohibition period.
In addition to the above, the NRC may take enforcement action against a licensee that may
affect an individual, where the conduct of the individual calls into question the NRC’s reasonable
assurance that licensed activities will be properly conducted. The NRC may take enforcement
action for reasons that would warrant refusal to issue a license on an original application.
Accordingly, appropriate enforcement actions may be taken regarding matters that raise issues
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of integrity (e.g., lying to the NRC), competence, fitness for duty, or other matters that may not
necessarily be a violation of specific Commission requirements.
4.3
Civil Penalties to Individuals
Except for individuals subject to civil penalties under Section 206 of the ERA, as amended, the
NRC will not normally impose a civil penalty against an individual. However, Section 234 of the
AEA gives the Commission authority to impose civil penalties on “any person.” Furthermore,
any person, whether or not a licensee of the Commission, who violates any regulations adopted
under Section 147, “Safeguards Information,” of the AEA will be subject to the full range of
enforcement sanctions, including civil penalties. Section 11s of the AEA broadly defines
“person” to include individuals, a variety of organizations, and their representatives or agents.
The NRC may issue a civil penalty to any individual who deliberately releases
Safeguards Information (SGI), including SGI-M, regardless of whether that individual is
employed by a licensee. If an individual deliberately released or failed to properly
control SGI after employment ends with a licensee, the NRC will typically consider
individual enforcement actions, including civil penalties in accordance with this Policy, as
described below.
The NRC will typically not issue a civil penalty to an individual for non-deliberate
violations of SGI requirements if that individual’s employer (a licensee, certificate holder,
applicant for a license or a certificate of compliance, or contractor) places the violation in
its corrective action program and has taken, or plans to take, corrective actions to
restore compliance. The NRC will consider, based on the circumstances of a case, the
appropriateness of a civil penalty for non-deliberate releases of SGI by an individual in
which the employer failed to take or plan to take corrective actions and for cases
involving deliberate or non-deliberate releases of SGI by an individual after employment
has ended with a licensee.
The NRC considers an individual’s reasons and potential motivations for disclosing SGI
and the willingness of the individual to correct or mitigate the release of information in
determining if a civil penalty is to be issued and in determining the final civil penalty
amount. The NRC typically reserves civil penalties for cases involving egregious
violations and for individuals who refuse to correct or mitigate the release of information.
Table A in Section 8.0 of this Policy lists the base civil penalty to individuals who release
SGI. The intent of civil penalties to individuals is to serve as a deterrent; these penalties
generally do not require a base civil penalty as high as that issued to a licensee or
contractor. However, willful violations may support a civil penalty outside of the range
listed in Section 8.0.
Section 6.13, “Information Security,” of this Policy provides examples of violations to
help determine the severity levels of violations. Also, in determining the appropriate SL
for the release of SGI, the NRC will consider the type of SGI information disclosed, its
availability to the public, the damage or vulnerability that the information caused or may
cause to the licensee that possessed ownership of the SGI, and the damage that the
information caused or could cause to public health and safety. The NRC will also use
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SGI-related significance determination process (under the Reactor Oversight Process)
information, when available, to inform the SL determination.
4.4
Confirmatory Orders to Individuals
Agreements with individuals reached as a result of the ADR process are normally formalized by
the issuance of a Confirmatory Order. ADR is typically offered to individuals consistent with the
process used for licensees (see Section 2.4.3 of this Policy).
5.0
PUBLIC AVAILABILITY OF INFORMATION REGARDING ENFORCEMENT ACTIONS
In accordance with 10 CFR 2.390, “Public Inspections, Exemptions, Requests for Withholding,”
enforcement actions and licensees’ responses are normally made publicly available for
inspection. However, some security-related information and medical records, except if obtained
pursuant to the Commission’s regulations, will not be made available to the public. The NRC
Office of Public Affairs is responsible for making final decisions as to whether press releases will
be issued; however, such releases are normally issued for Orders and civil penalties at the
same time that the Order or proposed imposition of the civil penalty is issued. Press releases
may also be issued when a civil penalty is withdrawn or substantially mitigated. Press releases
are not normally issued for NOVs that are not accompanied by Orders or proposed civil
penalties, unless the issue or licensee involved is of some particular interest.
6.0
VIOLATION EXAMPLES
The violation examples in this Policy are intentionally broad in scope so as to serve as a set of
guiding examples that are neither exhaustive nor controlling for making severity level
determinations. Licensed activities are placed in the most appropriate activity area in light of the
particular violation involved, including activities not directly covered by one of the listed areas.
The violation examples are not intended to address every possible circumstance. However,
when an enforcement case scenario very nearly achieves all or some of the criteria set forth in
an example, the case should be considered to be at the severity level of that example. For
example, when using the examples in Section 6.7, “Health Physics”, if the circumstances of a
case are such that one or more of the severity levels in an example were very nearly reached,
and it was only fortuitous that the limit was not actually met or exceeded, then the severity level
for the subject example would be applicable. Additionally, if the circumstances for a case do not
squarely fit any particular violation example, a comparable example in the same activity area
may be considered to determine the severity (e.g., the case for an industrial licensee presents a
set of circumstances and considerations comparable to those for a medical example provided in
Section 6.3, Materials Operations”; hence, the severity level for the medical example can be
applied).
Many examples are written to reflect the risks associated with the use of nuclear
materials. However, violations during construction generally occur before the nuclear
material and its associated risk are present. Therefore, the NRC will consider the lower
risk significance of violations that occur during construction in the areas of emergency
preparedness, reactor operator licensing, and security and may reduce the severity level
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for those violations from that indicated by the examples in those areas. In order to
maintain consistent application, the staff must coordinate with the Office of Enforcement
before applying this lower risk significance concept for violations that occur during
construction.
6.1
Reactor Operations
a.
SL I violations involve, for example:
b.
1.
A system9 that is part of the primary success path and which functions or
actuates to mitigate a Design Basis Accident (DBA) or transient that either
assumes the failure of or presents a challenge to the integrity of a fission product
barrier is unable to perform its licensing basis safety function10 when actually
called on to function;
2.
An inadvertent or unplanned criticality; or
3.
A technical specification safety limit is exceeded.
SL II violations involve, for example:
1.
c.
A system that is part of the primary success path and which functions or
actuates to mitigate a DBA or transient that either assumes the failure of or
presents a challenge to the integrity of a fission product barrier would be unable
to perform its licensing basis safety function had it been called upon to function.
SL III violations involve, for example:
1.
A licensee fails to shut down the reactor or follow remedial actions permitted by a
technical specification action requirement when a Limiting Condition for
Operation (LCO) is not met (i.e., noncompliance with 10 CFR 50.36(c)(2)(i));
2.
A system that is part of the primary success path and which functions or actuates
to mitigate a DBA or transient that either assumes the failure of or presents a
challenge to the integrity of the fission product barrier not being able to perform
its licensing basis safety function because it is not fully qualified (per the IMC
Part 9900, ODP) (e.g., materials or components not environmentally qualified);
3.
Changes in reactor parameters cause unanticipated reductions in margins to
safety;
4.
A licensee fails to adequately oversee contractors, which results in the use of
9
The term “system” as used in these violation examples includes administrative control systems, managerial
control systems, as well as physical systems.
10
“Licensing basis safety function” means the total safety function and is not directed toward a loss of
redundancy. A loss of one subsystem does not defeat the intended safety function as long as the other subsystem is
operable.
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NRC Enforcement Policy
safety-significant products or services that are defective or of indeterminate
quality;
d.
6.2
5.
Equipment failures caused by inadequate or improper maintenance substantially
complicate recovery from a plant transient;
6.
A licensee fails to obtain prior Commission approval required by 10 CFR 50.59
for a change that has a consequence evaluated by the SDP as having
low-to-moderate or greater safety significance (i.e., white, yellow, or red); or
7.
A licensee fails to update the FSAR as required by 10 CFR 50.71(e), and the
un-updated FSAR is used to perform a 10 CFR 50.59 evaluation for a change to
the facility or procedures, implemented without Commission approval, that results
in a condition evaluated as having low-to-moderate or greater safety significance
(i.e., white, yellow, or red) by the SDP.
SL IV violations involve, for example:
1.
A failure to comply with a technical specification action requirement
demonstrates misapplication of the conventions in technical specifications
Section 1.0, “Use and Application”, or the allowances for LCO and surveillance
requirement applicabilities in technical specifications Section 3.0;
2.
Violations of 10 CFR 50.59 result in conditions evaluated as having very low
safety significance (i.e., green) by the SDP;
3.
A licensee fails to update the FSAR as required by 10 CFR 50.71(e) but the lack
of up-to-date information has not resulted in any unacceptable change to the
facility or procedures; or
4.
A licensee fails to adequately assess the risk of plant operations associated with
implementation of a risk-informed technical specification allowance such that the
allowance is implemented inappropriately.
Fuel Cycle Operations
This section provides examples in the area of fuel cycle operations for licensees with an
integrated safety analysis (ISA) under 10 CFR Part 70, “Domestic Licensing of Special Nuclear
Material,” Subpart H, “Additional Requirements for Certain Licensees Authorized To Possess a
Critical Mass of Special Nuclear Material,” and fuel cycle licensees without an ISA. The NRC
will determine the appropriate severity level for a specific violation by using licensee ISAs and
other applicable risk information.
a.
SL I violations involve, for example:
1.
Under 10 CFR Part 70, Subpart H, a high consequence event occurs; or
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2.
b.
c.
For licensees not under 10 CFR Part 70, Subpart H, the occurrence of an event
with a consequence commensurate with a 10 CFR Part 70 high consequence, as
a result of licensed materials or hazardous chemicals produced from licensed
materials.
SL II violations involve, for example:
1.
Under 10 CFR Part 70, Subpart H, a high-consequence event is “not unlikely”
based on a licensee’s ISA;
2.
Under 10 CFR Part 70, Subpart H, an intermediate-consequence event occurs;
3.
For licensees not under 10 CFR Part 70, Subpart H, a very substantial increase
in the likelihood of a consequence commensurate with a Part 70 high
consequence occurs; or
4.
For licensees not under 10 CFR Part 70, Subpart H, an event with a
consequence commensurate with a Part 70 intermediate consequence occurs as
the result of licensed materials or hazardous chemicals produced from licensed
materials.
SL III violations involve, for example:
1.
Under 10 CFR Part 70, Subpart H, a high-consequence event is “unlikely” based
on a licensee’s ISA;
2.
Under 10 CFR Part 70, Subpart H, an intermediate-consequence event is “not
unlikely” based on a licensee’s ISA;
3.
For licensees not under 10 CFR Part 70, Subpart H, a substantial increase in the
likelihood of a consequence commensurate with a Part 70 high consequence
occurs;
4.
For licensees not under 10 CFR Part 70, Subpart H, a significant increase in the
likelihood of a consequence commensurate with a Part 70 intermediate
consequence occurs;
5.
A significant failure to comply with the action statement for a technical safety
requirement LCO results in the appropriate action not being taken within the
required time;
6.
Under 10 CFR 70.72, “Facility Changes and Change Process,” or 10 CFR 76.68,
“Plant Changes,” a significant failure to adequately evaluate a change to the
facility results in implementation of the change without a required license or
certificate amendment;
7.
Under 10 CFR 70.24 or 10 CFR 76.89, both titled “Criticality Accident
Requirements,” a criticality accident alarm system fails to provide either detection
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or annunciation coverage for a substantial time period during which operations
involving handling or using fissile material occurred; or
8.
d.
A licensee fails to meet or implement more than one emergency planning
standard.
SL IV violations involve, for example:
1.
Under 10 CFR Part 70, Subpart H, a licensee fails to meet the requirements of
10 CFR 70.61, “Performance Requirements,” or Appendix A, “Reportable Safety
Events,” to 10 CFR Part 70, and the failure does not result in a SL I, II, or III
violation;
2.
A failure of safety systems or controls occurs such that an acceptable safety
margin has not been maintained, and the failure does not result in a SL I, II, or III
violation;
3.
A less significant failure to comply with the action statement for a technical safety
requirement LCO occurs when the appropriate action was not taken within the
required time;
4.
Under 10 CFR 70.72 or 10 CFR 76.68, a less significant failure to adequately
evaluate a change to the facility results in implementation of the change without a
required license or certificate amendment. The failure does not result in a SL I,
II, or III violation;
5.
Under 10 CFR 70.24 or 10 CFR 76.89, a criticality accident alarm system fails to
provide either detection or annunciation coverage of fissile material operations
during a time period when fissile material was handled, used, or stored;
6.
A licensee fails to meet or implement more than one emergency planning
standard involving assessment or notification during an Alert emergency; or
7.
A licensee fails to meet or implement any emergency planning standard or
requirement not directly related to assessment and notification (e.g., emergency
response training, emergency equipment maintenance).
6.3
Materials Operations
a.
SL I violations involve, for example:
1.
The loss of control over licensed or certified activities, including chemical
processes that are integral to the licensed or certified activity, results in serious
injury or loss of life;
2.
A system designed to prevent or mitigate a serious safety event is inoperable
when actually required to perform its design function, and this results in serious
injury or loss of life;
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NRC Enforcement Policy
b.
c.
3.
Failure to use a properly prepared written directive as required by 10 CFR 35.40,
“Written Directives,” or failure to develop, implement, or maintain procedures for
administrations requiring a written directive as required by 10 CFR 35.41,
“Procedures for Administrations Requiring a Written Directive,” results in serious
injury or loss of life; or
4.
Failure to have or to follow written operating procedures as required by
10 CFR 36.53, “Operating and Emergency Procedures,” results in a serious
injury or loss of life.
SL II violations involve, for example:
1.
The loss of control over licensed or certified activities, including chemical
processes that are integral to the licensed or certified activity, results in the
substantial potential for a significant injury or loss of life, whether or not
radioactive material is released;
2.
A system designed to prevent or mitigate a serious safety event is inoperable
when actually required to perform its design function;
3.
A substantial programmatic failure to implement written directives or procedures
for administrations requiring a written directive, such as a failure of the licensee’s
procedures to address one or more of the elements in 10 CFR 35.40 or
10 CFR 35.41, or a failure to train personnel in those procedures, results in a
medical event; or
4.
Failure to have or to follow written operating procedures as required by
10 CFR 36.53 results in a substantial potential (e.g., an event did not occur, but
no barriers, neither procedural nor system, including interlocks, would have
prevented it, and the event was not highly unlikely to occur) for a serious injury or
death.
SL III violations involve, for example:
1.
2.
A system designed to prevent or mitigate a serious safety event has one of the
following characteristics:
(a)
It is unable to perform its intended function under certain conditions
(e.g., a safety system is not operable unless the required backup power is
available), or
(b)
It is outside design specifications to the extent that a detailed evaluation
would be required to determine its operability;
A programmatic failure occurs to implement written directives or procedures for
administrations requiring a written directive, such as the following:
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NRC Enforcement Policy
(a)
A licensee’s procedures fail to address one or more of the elements in
10 CFR 35.40 or 10 CFR 35.41,
(b)
A licensee fails to train personnel in procedures for administrations
requiring a written directive,
(c)
A nonisolated failure occurs to use and follow written directives or
procedures for administrations requiring a written directive; or
(d)
A licensee fails to have procedures or requirements for written directives
or fails to have procedures for administrations that require written
directives.
3.
A licensee fails to secure a portable gauge with at least two independent physical
controls whenever the gauge is not under the control and constant surveillance of
the licensee as required by 10 CFR 30.34(i));
4.
A significant failure to implement the requirements of 10 CFR Part 34, “Licenses
for Industrial Radiography and Radiation Safety Requirements for Industrial
Radiographic Operations,” during radiographic operations includes, but is not
limited to, the following:
5.
6.
(a)
During radiographic operations at a location other than a permanent
radiographic installation, a licensee fails to have present a radiographer
and at least one additional radiographer or qualified individual,
(b)
A licensee fails, during radiographic operations, to use radiographic
equipment, radiation survey instruments, or personnel monitoring devices
as required by 10 CFR Part 34, or
(c)
During radiographic operations, a failure to stop work occurs, after a
pocket dosimeter is found to have gone off-scale or after an electronic
dosimeter reads greater than 200 millirem (mrem), and before a
determination is made of the individual’s actual radiation exposure;
An unqualified person conducts licensed activities. The unqualified person is
characterized by either of the following:
(a)
lacking adequate qualifications, experience, or training to safely conduct
activities, or
(b)
lacking the required certification or training for positions such as
radiographer; authorized user under 10 CFR Part 35, “Medical Use of
Byproduct Material”; or irradiator operator under 10 CFR 36.51, “Training”
Licensed material is used on humans where such use is not authorized;
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NRC Enforcement Policy
7.
A licensee authorizes the release from its control of an individual who does not
meet the release criteria in 10 CFR 35.75, “Release of Individuals Containing
Unsealed Byproduct Material or Implants Containing Byproduct Material;”
8.
An individual without supervision operates an irradiator when the individual has
not been trained as required by 10 CFR 36.51;
9.
A programmatic failure occurs to have and follow written operating procedures as
required by 10 CFR 36.53;
10.
A programmatic failure occurs to perform inspection and maintenance checks as
required by 10 CFR 36.61, “Inspection and Maintenance;”
11.
A licensee fails to seek required NRC approval before the implementation of a
significant change in licensed activities that has radiological or programmatic
significance, such as the following:
12.
d.
(a)
a change in ownership,
(b)
a change in the location where licensed activities are being conducted or
where licensed material is being stored,
(c)
an increase in the quantity or type of radioactive material being processed
or used that has radiological significance, or
(d)
a change in program status with regard to the RSO named on its license
(e.g., licensee fails to have an RSO; licensee appoints an unqualified
individual as RSO);
Failures occur involving decommissioning requirements, such as the following:
(a)
a significant failure to meet decommissioning as required by regulation or
license condition, or
(b)
failure to meet required schedules without adequate justification
SL IV violations involve, for example:
1.
A licensee fails to use a properly prepared written directive as required by
10 CFR 35.40, or fails to develop, implement, or maintain procedures for
administrations requiring a written directive as required by 10 CFR 35.41,
whether or not a medical event occurs, provided that the failures are
characterized by all of the following:
(a)
are isolated
(b)
do not demonstrate programmatic weaknesses in implementation
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NRC Enforcement Policy
(c)
have limited consequences if a medical event is involved;
2.
A licensee fails to keep the records required by 10 CFR 35.2040, “Records of
Written Directives,” and 10 CFR 35.2041, “Records for Procedures for
Administrations Requiring a Written Directive;”
3.
A licensee fails to implement procedures including, but not limited to,
recordkeeping, surveys, and inventories;
4.
A licensee fails to comply with the U.S. Department of Transportation
requirement to provide hazardous material (HAZMAT) employee training as
required by 10 CFR 71.5(a);
5.
There is an isolated failure to have and to follow written operating procedures as
required by 10 CFR 36.53;
6.
A licensee fails to document the required certification or training for positions
such as radiographer, authorized user under 10 CFR Part 35, or irradiator
operator under 10 CFR 36.51;
7.
A licensee fails to seek required NRC approval before the implementation of a
change in ownership that results in little or no adverse impact on radiological or
programmatic activities or on the NRC’s ability to inspect licensed activities, such
that the locations and types of activities are unaffected by the unauthorized
license transfer;
8.
A licensee fails to seek required NRC approval prior to replacement of the RSO,
where the RSO was evaluated as qualified; or
9.
A licensee fails to seek NRC approval, when required, before changing the
location where licensed activities are being conducted or where licensed material
is being stored that has little or no radiological or programmatic significance, and
all other safety and security requirements have been met.
6.4
Licensed Reactor Operators
a.
SL I violations involve, for example:
1.
A licensed operator, or a senior operator actively performing the functions
covered by that position, is involved in procedural errors that result in, or
exacerbate the consequences of, an Alert or higher level emergency, and, at the
time the procedural errors occurred, was determined to be either of the following:
(a)
unfit for duty as a result of a confirmed positive test for drugs or alcohol at
cutoff levels established by the licensee, or
(b)
under the influence of any prescription or over-the-counter drug as
described in 10 CFR 55.53(j), or
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(c)
b.
SL II violations involve, for example:
1.
2.
3.
c.
unfit for duty as determined by a post event fatigue assessment required
by 10 CFR 26.211(a)(3).
A licensed operator, or a senior operator actively performing the functions
covered by that position, is involved in procedural errors, and, at the time the
procedural error occurred, was determined to be any of the following:
(a)
unfit for duty as a result of a confirmed positive test for drugs or alcohol at
cutoff levels established by the facility licensee,
(b)
under the influence of any prescription or over-the-counter drug as
described in 10 CFR 55.53(j),
(c)
in noncompliance with a condition stated on the individual’s license, or
(d)
unfit for duty as determined by a post event fatigue assessment required
by 10 CFR 26.211(a)(3);
A deliberate compromise (see 10 CFR 55.49, “Integrity of Examinations and
Tests”) occurs of an application, test, or examination required by 10 CFR Part 55,
“Operators’ Licenses,” or inaccurate or incomplete information is deliberately
provided to the NRC and has any of the following effects:
(a)
in the case of initial operator licensing, contributes to an individual being
granted an operator or senior operator license, or
(b)
in the case of operator requalification, contributes to an individual being
permitted to continue to perform the functions of an operator or senior
operator, or
(c)
contributes to a medically unqualified individual performing the functions
of a licensed operator or senior operator; or
A licensed operator or senior operator, while within the protected area, is
involved in the use, sale, or possession of illegal drugs or the consumption of
alcoholic beverages.
SL III violations involve, for example:
1.
A licensed operator, or a senior operator actively performing the functions
covered by that position, is determined to be any of the following:
(a)
unfit for duty as a result of a confirmed positive test for drugs or alcohol at
cutoff levels established by the licensee,
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d.
(b)
under the influence of any prescription or over-the-counter drug as
described in 10 CFR 55.53(j),
(c)
in noncompliance with a condition stated on the individual’s license, or
(d)
unfit for duty as determined by a post event fatigue assessment required
by 10 CFR 26.211(a)(3);
2.
A licensed operator, or a senior operator actively performing the functions
covered by that position, is inattentive to duty;
3.
A licensed operator or senior operator is involved in the use, sale, or possession
of illegal drugs;
4.
A nonwillful compromise (see 10 CFR 55.49, “Integrity of Examinations and
Tests”) of an application, test, or examination required by 10 CFR Part 55, or
inaccurate or incomplete information inadvertently provided to the NRC,
subsequently contributes to the NRC making an incorrect regulatory decision,
such as the following:
(a)
in the case of initial operator licensing, contributes to an individual being
granted an operator or senior operator license, or
(b)
in the case of operator requalification, contributes to an individual being
permitted to continue to perform the functions of an operator or senior
operator, or
(c)
contributes to a medically unqualified individual performing the functions
of a licensed operator or senior operator.
SL IV violations involve, for example:
1.
A nonwillful compromise (see 10 CFR 55.49) of an application, test, or
examination required by 10 CFR Part 55. For example,
(a)
cases of inaccurate or incomplete information inadvertently provided to
the NRC that do not contribute to the NRC making an incorrect regulatory
decision as a result of the originally submitted information; or
(b)
an individual operator who did not meet the American National Standards
Institute/American Nuclear Society (ANSI/ANS) 3.4, “Medical Certification
and Monitoring of Personnel Requiring Operator Licenses for Nuclear
Power Plants,” Section 5, “Health Requirements and Disqualifying
Conditions,” as certified on NRC Form 396, “Certification of Medical
Examination by Facility Licensee,” required by 10 CFR 55.23,
Certification, but who did not perform the functions of a licensed operator
or senior operator while having a disqualifying medical condition; or
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(c)
an individual operator who did not meet ANSI/ANS 3.4, Section 5, as
certified on NRC Form 396, “Certification of Medical Examination by
Facility Licensee,” required by 10 CFR 55.23, due to an incomplete
medical examination, but was subsequently found to meet the health
requirements for licensing; or
(d)
an individual operator who met ANSI/ANS 3.4, Section 5, as certified on
NRC Form 396, required by 10 CFR 55.23, but failed to report a condition
that would have required a license restriction to establish or maintain
medical qualification based on having the undisclosed medical condition.
6.5
Facility Construction (10 CFR Part 50 and 52 Licensees and Fuel Cycle Facilities)
a.
SL I violations involve, for example:
1.
b.
c.
A significant breakdown of a licensee’s QA program that results in multiple
structures, systems, or components being completed11 in a manner such that
they would not have satisfied their intended safety purpose.
SL II Violations involve, for example:
1.
A significant breakdown occurs in the QA program, as exemplified by multiple
deficiencies in construction QA related to more than one work activity (e.g.,
structural, piping, electrical, foundations). These deficiencies involve the
licensee’s failure to provide adequate oversight or take prompt corrective action
and involve multiple examples of deficient construction or construction of
unknown quality as the result of inadequate program implementation; or
2.
Multiple structures, systems, or components are completed in a manner that
would have an adverse impact on the safety of operations.
SL III violations involve, for example:
1.
A breakdown occurs in a licensee’s QA program for construction related to a
single work activity (e.g., structural, piping, electrical, foundations). This
significant deficiency involves the licensee’s failure to provide adequate oversight
or take prompt corrective action and entails multiple examples of deficient
construction or construction of unknown quality as the result of inadequate
program implementation;
2.
A failure to confirm the design safety requirements of a structure, system, or
component as the result of inadequate preoperational test program
implementation;
3.
Ineffective corrective actions result in multiple examples of recurring significant
11
The term “completed” as used in this supplement means completion of a construction activity,
including review and acceptance by the construction Quality Control or Quality Assurance organization.
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NRC Enforcement Policy
deficiencies associated with a single construction activity;
d.
4.
A licensee fails to obtain prior Commission approval required by 10 CFR 50.59 or
10 CFR Part 52, Appendix A-D for a change that results in a condition evaluated
as having low-to-moderate or greater safety significance; or
5.
A licensee fails to update the FSAR as required by 10 CFR 50.71(e), and the
FSAR is used to perform a 10 CFR 50.59 or 10 CFR Part 52, Appendix A-D
evaluation for a change to the facility or procedures, implemented without
Commission approval, that results in a condition evaluated as having
low-to-moderate or greater safety significance.
SL IV violations involve, for example:
1.
A licensee fails to meet regulatory requirements, including one or more QA
criteria that have more than minor safety or security significance;
2.
A licensee fails to establish, maintain, or implement adequate controls over
procurement, construction, examination, or testing processes that are important
to safety;
A licensee fails to adequately implement QA processes or procedures;
3.
6.6
4.
A licensee fails to maintain QA records to demonstrate the adequacy of
construction;
5.
A licensee fails to implement adequate 10 CFR Part 21 processes or procedures
that have more than minor safety or security significance;
6.
Violations of 10 CFR 50.59 or 10 CFR Part 52, Appendix A-D result in conditions
evaluated as having very low safety significance; or
7.
A licensee has failed to update the FSAR as required by 10 CFR 50.71(e) but the
lack of up-to-date information has not resulted in any unacceptable change to the
facility or procedures.
Emergency Preparedness
These examples are appropriate for violations at operating power reactor facilities for those
violations that are dispositioned under traditional enforcement rather than under the ROP. For
operating power reactors, the NRC treats participant performance deficiencies identified in
emergency exercises under the ROP. This section also provides examples of violations in the
area of emergency preparedness at nonpower reactor facilities.
a.
SL I violations involve, for example:
1.
During an actual General Emergency, a licensee fails to promptly do any of the
following:
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b.
(a)
correctly classify and declare the event,
(b)
make required notifications (i.e., notifications required by the licensee’s
emergency plan, 10 CFR 50.72, “Immediate Notification Requirements for
Operating Nuclear Power Reactors,” or 10 CFR Part 50, Appendix E,
“Emergency Planning and Preparedness for Production and Utilization
Facilities”) to responsible Federal, State, and local agencies, or
(c)
respond to the event (e.g., assess actual or potential offsite
consequences, activate emergency response facilities, and augment shift
staff).
SL II violations involve, for example:
1.
During an actual Site Area Emergency, a licensee fails to promptly do any of the
following:
(a)
correctly classify and declare the event,
(b)
make required notifications (i.e., notifications required by the licensee’s
emergency plan, 10 CFR 50.72, or 10 CFR 50, Appendix E) to
responsible Federal, State, and local agencies, or
(c)
respond to the event (e.g., assess actual or potential offsite
consequences, activate emergency response facilities, and augment shift
staff);
2.
A licensee loses its ability to meet or implement any regulatory requirement
related to assessment (other than emergency classification) or notification12 such
that the required function would not be implemented during the response to an
actual emergency; or
3.
An emergency action level (EAL) initiating condition (IC) has been rendered
ineffective such that any General Emergency would not be declared for a
particular off-normal event.13
12
As used in this example, “assessment” includes classification, assessment of the impact of a release of
radioactivity, and the making of protective action recommendations; “notification” includes initial and followup
notifications to offsite response organizations. For power reactors, this includes the risk-significant planning
standards in 10 CFR 50.47(b)(4), (b)(5), (b)(9), and (b)(10). See Inspection Manual Chapter 0609, Appendix B,
Emergency Preparedness Significance Determination Process, Section 5.0, for examples of conditions that may
cause a required function not to be implemented or to be implemented in a degraded manner.
13
An IC/EAL may be rendered ineffective by changes to facility procedures, systems, or equipment; errors in
numeric thresholds; or any other cause that could result in an IC that should be declared not being declared in a
timely and accurate manner following the change.
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c.
SL III violations involve, for example:
1.
d.
During an actual Alert emergency, a licensee fails to promptly do any of the
following:
(a)
correctly classify and declare the event,
(b)
make required notifications (i.e., notifications required by the licensee’s
emergency plan, 10 CFR 50.72, or 10 CFR 50, Appendix E) to
responsible Federal, State, and local agencies, or
(c)
respond to the event (e.g., assess actual or potential offsite
consequences, activate emergency response facilities, and augment shift
staff);
2.
A licensee’s ability to meet or implement any regulatory requirement related to
assessment (other than emergency classification) or notification is degraded
such that the effectiveness of the emergency plan decreases. Although the
regulatory requirement could be implemented during the response to an actual
emergency, the implementation would be degraded (e.g., not fully effective,
inappropriately delayed);
3.
An EAL IC has been rendered ineffective such that any General Emergency
would not be declared for a particular off-normal event, but because of redundant
EALs for that IC, an appropriate declaration could be made but not within the
15-minute requirement;
4.
An EAL IC has been rendered ineffective such that any Site Area Emergency
would not be declared for a particular off-normal event; or
5.
A licensee’s ability to meet or implement any regulatory requirement not related
to assessment or notification is lost such that the required function would not be
implemented during the response to an actual emergency.
SL IV violations involve, for example:
1.
The licensee’s ability to meet or implement any regulatory requirement not
related to assessment or notification such that the effectiveness of the
emergency plan decreases. Although the regulatory requirement could be
implemented during the response to an actual emergency, the implementation
would be degraded (e.g., not fully effective, inappropriately delayed);
2.
An EAL IC has been rendered ineffective such that any General Emergency
would not be declared for a particular off-normal event, but because of redundant
EALs for that IC, an appropriate declaration could be made in an accurate and
timely manner;
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6.7
3.
An EAL IC has been rendered ineffective such that any Site Area Emergency
would not be declared for a particular off-normal event, but because of redundant
EALs for that IC, an appropriate declaration could be made but not within the
15-minute requirement; or
4.
An EAL IC has been rendered ineffective such that any Alert Emergency or
Notice of Unusual Event would not be declared for a particular off-normal event,
or declared in a degraded manner for a particular off-normal event.
Health Physics
Personnel overexposures and associated violations incurred during a lifesaving or other
emergency response effort will be treated on a case-by-case basis.
a.
b.
SL I violations involve, for example:
1.
An adult worker receives a radiation exposure during any year in excess of
25 rem (0.25 sievert (Sv)) total effective dose equivalent; 75 rem (0.75 Sv) to the
lens of the eye; or 250 rem (2.5 Sv) to the skin of the whole body, or to the feet,
ankles, hands, or forearms, or to any other organ or tissue;
2.
A declared pregnant woman receives a radiation exposure over the gestation
period of the embryo/fetus of 2.5 rem (0.025 Sv) total effective dose equivalent;
3.
A minor worker (i.e., an individual less than 18 years of age) receives a radiation
exposure during any year in excess of 2.5 rem (0.025 Sv) total effective dose
equivalent; 7.5 rem (0.075 Sv) to the lens of the eye; or 25 rem (0.25 SV) to the
skin of the whole body, or to the feet, ankles, hands or forearms, or to any other
organ or tissue;
4.
A member of the public receives an annual exposure in excess of 1 rem
(0.01 Sv) total effective dose equivalent;
5.
A release of radioactive material occurs to an unrestricted area in annual
average concentrations in excess of 50 times the limits for members of the public
as stated in 10 CFR 20.1302(b)(2)(i); or
6.
Disposal of licensed material occurs in quantities or concentrations in excess of
10 times the limits of 10 CFR 20.2003, “Disposal by Release into Sanitary
Sewerage.”
SL II Violations involve, for example:
1.
An adult worker receives a radiation exposure during any year in excess of
violations 10 rem (0.1 Sv) total effective dose equivalent; 30 rem (0.3 Sv) to the
lens of the eye; or 100 rem (1.0 Sv) to the skin of the whole body, or to the feet,
ankles, hands, or forearms, or to any other organ or tissue;
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c.
2.
A declared pregnant woman receives a radiation exposure over the gestation
period of the embryo/fetus in excess of 1.0 rem (0.01 Sv) total effective dose
equivalent;
3.
A minor worker receives a radiation exposure during any year in excess of
1.0 rem (0.01 Sv) total effective dose equivalent; 3.0 rem (0.03 Sv) to the lens of
the eye; or 10 rem (0.1 Sv) to the skin of the whole body, or to the feet, ankles,
hands, or forearms, or to any other organ or tissue;
4.
A member of the public receives an annual exposure in excess of 0.5 rem
(5 millisieverts (mSv)) total effective dose equivalent;
5.
Release of radioactive material occurs to an unrestricted area in annual average
concentrations in excess of 10 times the limits stated in 10 CFR 20.1302(b)(2)(i)
(except when the Commission has approved operation up to 0.5 rem (5 mSv) per
year under 10 CFR 20.1301(c)); or
6.
Disposal of licensed material occurs in quantities or concentrations in excess of
5 times the limits of 10 CFR 20.2003.
SL III Violations involve, for example:
1.
An adult worker receives a radiation exposure during any year in excess of 5 rem
(0.05 Sv) total effective dose equivalent; 15 rem (0.15 Sv ) to the lens of the eye;
or 50 rem (0.5 Sv) to the skin of the whole body or to the feet, ankles, hands, or
forearms, or to any other organ or tissue;
2.
A declared pregnant woman receives a radiation exposure over the gestation
period of the embryo/fetus in excess of 0.5 rem (5 mSv) total effective dose
equivalent (except when doses are in accordance with the provisions of
10 CFR 20.1208(d));
3.
A minor worker receives a radiation exposure during any year in excess of
0.5 rem (5 mSv) total effective dose equivalent; 1.5 rem (0.015 Sv) to the lens of
the eye; or 5 rem (0.05 Sv) to the skin of the whole body, or to the feet, ankles,
hands or forearms, or to any other organ or tissue;
4.
An annual exposure of a member of the public in excess of 0.1 rem (1 mSv) total
effective dose equivalent (except when operation up to 0.5 rem (5 mSv) per year
under 10 CFR 20.1301(c));
5.
A release of radioactive material occurs to an unrestricted area in annual
average concentrations in excess of 2 times the effluent concentration limits
referenced in 10 CFR 20.1302(b)(2)(i) (except when the Commission has
approved operation up to 0.5 rem (5 mSv) per year under 10 CFR 20.1301(c));
6.
A substantial potential exists for exposures or releases in excess of the
applicable limits in 10 CFR 20.1001–20.2401, whether or not an exposure or
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release occurs;
d.
7.
Disposal of licensed material occurs in quantities or concentrations in excess of
the regulatory limits of 10 CFR 20.2003;
8.
A licensee releases, for unrestricted use, contaminated or radioactive material or
equipment that poses a realistic potential for exposure of the public exceeding
the annual dose limits for members of the public;
9.
A technically unqualified person conducts licensee activities; or
10.
A violation involves failure to secure, or maintain surveillance over, licensed
material in the following situations:
(a)
involves licensed material in any aggregate quantity greater than
1,000 times the quantity specified in Appendix C, “Quantities of Licensed
Material Requiring Labeling,” to 10 CFR Part 20, “Standards for
Protection against Radiation,”
(b)
involves licensed material in any aggregate quantity greater than 10 times
the quantity specified in Appendix C to 10 CFR Part 20, where the failure
is accompanied by the absence of a functional program to detect and
deter security violations that includes training, staff awareness, detection
(including auditing), and corrective action (including disciplinary action), or
(c)
results in a substantial potential for exposures or releases in excess of
the applicable limits in 10 CFR Part 20.
SL IV violations involve, for example:
1.
Intakes exceed those specified in 10 CFR 20.1201(e) or the equivalent for
10 CFR 20.1207, “Occupational Dose Limits for Minors;”
2.
A release of radioactive material occurs to an unrestricted area in annual
average concentrations in excess of the limits for members of the public as
referenced in 10 CFR 20.1302(b)(2)(i) (except when the Commission has
approved operation up to 0.5 rem (5 mSv) per year under 10 CFR 20.1301(c));
3.
A radiation dose rate in an unrestricted or controlled area exceeds 0.002 rem
(0.02 microsieverts) in any 1 hour (2 mrem/hour) or 50 mrem (0.5 mSv) in a year;
4.
A licensee fails to conduct required leakage or contamination tests or to use
properly calibrated equipment, although the failure does not contribute to an
event;
5.
Doses to a member of the public exceed any of the U.S. Environmental
Protection Agency’s generally applicable environmental radiation standards in
40 CFR Part 190, “Environmental Radiation Protection Standards for Nuclear
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Power Operations,” as required by 10 CFR 20.1301(e); or
6.
6.8
An isolated failure occurs to secure, or maintain surveillance over, licensed
material in any aggregate quantity greater than 10 times the quantity specified in
Appendix C to 10 CFR Part 20, provided that both of the following apply:
(a)
The material is labeled as radioactive or located in an area posted as
containing radioactive materials, and
(b)
Such failure occurs despite a functional program to detect and deter
security violations that includes training, staff awareness, detection
(including auditing), and corrective action (including disciplinary action);
Transportation
Some transportation requirements apply to more than one licensee involved in the same activity
(e.g., a shipper and a carrier). When such a violation occurs, the NRC will direct enforcement
action against the responsible licensee or licensees.
a.
b.
SL I violations involve, for example:
1.
Failure to meet transportation requirements results in loss of control of
radioactive material with a breach in package integrity such that the material
causes a radiation exposure to a member of the public in excess of the
regulatory limits;
2.
Surface contamination exceeds 50 times the NRC limit; or
3.
External radiation levels exceed 10 times the NRC limit.
SL II violations involve, for example:
1.
Failure to meet transportation requirements results in loss of control of
radioactive material with a breach in package integrity such that there is a clear
potential for a member of the public to receive a radiation exposure in excess of
the regulatory limits;
2.
Surface contamination exceeds 10 times, but not more than 50 times, the NRC
limit;
3.
External radiation levels exceed 5 times, but not more than 10 times, the NRC
limit; or
4.
A licensee fails to make required initial notifications associated with SL I or II
violations.
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c.
SL III violations involve, for example:
1.
Surface contamination exceeds 5 times, but not more than 10 times, the NRC
limit;
2.
External radiation exceeds 1 times, but not more than 5 times, the NRC limit;
3.
A violation involves labeling, placarding, shipping paper, packaging, loading, or
other requirements that could reasonably result any of the following:
4.
d.
(a)
a significant failure to identify the type, quantity, or form of material
(b)
a failure of the carrier or recipient to exercise adequate controls
(c)
a substantial potential for either personnel exposure or contamination
above regulatory limits or improper transfer of material
A licensee fails to make required initial notification associated with SL III
violations.
SL IV Violations involve, for example:
1.
A breach of package integrity occurs without external radiation levels exceeding
the NRC limit or without contamination levels exceeding the NRC limits;
2.
Surface contamination is in excess of, but is not more than 5 times, the NRC
limit;
3.
A licensee fails to register as an authorized user of an NRC-Certified Transport
package;
4.
A licensee fails to demonstrate that packages for special-form radioactive
material meet applicable regulatory requirements; or
5.
A licensee fails to demonstrate that U.S. Department of Transportation
specifications are met for 7A Type A packages as required by 10 CFR 71.5,
“Transportation of Licensed Material.”
6.9
Inaccurate and Incomplete Information or Failure to Make a Required Report
a.
SL I violations involve, for example:
1.
A licensee official deliberately provides or maintains information known by the
licensee official to be incomplete or inaccurate. If the information had been
completely and accurately provided or maintained, it would likely have caused
the NRC to issue an Order requiring suspension or cessation of licensed activity
or other immediate action to protect the public health and safety or common
defense and security;
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(a)
2.
A deliberate withholding of information or a deliberate failure to make a required
report occurs. If the information had been provided or the report been made, it
would likely have caused the NRC to issue an Order requiring suspension or
cessation of licensed activity or other immediate action to protect the public
health and safety or common defense and security;
3.
A licensee official provides or maintains information with careless disregard of its
completeness or accuracy. If this information had been completely and
accurately provided or maintained, it would likely have caused the NRC to issue
an Order requiring suspension or cessation of licensed activity or other
immediate action to protect the public health and safety or common defense and
security;
(a)
b.
For example, deliberately incomplete or inaccurate information associated
with an inspections, tests, analyses, and acceptance criteria (ITAAC)
notification letter is submitted in accordance with 10 CFR 52.99,
“Inspection during Construction.” If the information had been complete
and accurate, it would likely have caused the NRC to issue an Order
halting a significant portion of construction activities;
For example, a licensee official submits incomplete or inaccurate
information associated with an ITAAC notification letter, in accordance
with 10 CFR 52.99, with careless disregard for its completeness and
accuracy. If this information had been complete and accurate, it would
likely have caused the NRC to issue an Order halting a significant portion
of construction activities;
4.
A withholding of information or a failure to make a required report occurs, with
careless disregard of the underlying requirement. If the information had been
provided or the report been made, it would likely have caused the NRC to issue
an Order requiring suspension or cessation of licensed activity or other
immediate action to protect the public health and safety or common defense and
security; or
5.
A deliberate failure to notify the Commission as required by 10 CFR Part 21,
“Reporting of Defects and Noncompliance,” occurs.
SL II violations involve, for example:
1.
A licensee official deliberately provides or maintains information known by the
licensee official to be incomplete or inaccurate. If the information had been
completely and accurately provided or maintained, it would likely have caused
the NRC to reconsider a regulatory position or undertake a substantial further
inquiry;
(a)
For example, a licensee official deliberately provides incomplete or
inaccurate information associated with an ITAAC notification letter,
submitted in accordance with 10 CFR 52.99. If this information had been
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NRC Enforcement Policy
complete and accurate, it would likely have caused the NRC to reject
closure of that ITAAC;
2.
A licensee official provides or maintains information with careless disregard of its
completeness or accuracy. If this information had been completely and
accurately provided or maintained, it would likely have caused the NRC to
reconsider a regulatory position or undertake a substantial further inquiry.
(a)
c.
For example, a licensee official provides incomplete or inaccurate
information associated with an ITAAC notification letter, submitted in
accordance with 10 CFR 52.99, with careless disregard for its
completeness and accuracy. If this information had been complete and
accurate, it would likely have caused the NRC to reject closure of that
ITAAC;
3.
A deliberate withholding of information or a deliberate failure to make a required
report occurs. If the information had been provided or the report been made, it
would likely have resulted in reconsideration of a regulatory position or
substantial further inquiry;
4.
A withholding of information or a failure to make a required report occurs with
careless disregard of the underlying requirement. If the information had been
provided or the report been made, it would likely have resulted in reconsideration
of a regulatory position or substantial further inquiry;
5.
Inaccurate or incomplete information is provided or maintained. If this
information had been completely and accurately provided or maintained, it would
likely have caused the NRC to issue an Order requiring suspension or cessation
of licensed activity or other immediate action to protect the public health and
safety or common defense and security;
6.
A withholding of information or a failure to make a required report occurs. If the
information had been provided or the report been made, it would likely have
caused the NRC to issue an Order requiring suspension or cessation of licensed
activity or other immediate action to protect the public health and safety or
common defense and security; or
7.
A licensee fails to make an immediate notification as required by
10 CFR 20.2202(a)(1) or (a)(2).
SL III violations involve, for example:
1.
Inaccurate or incomplete information is provided or maintained. If this
information had been completely and accurately provided or maintained, it would
likely have caused the NRC to reconsider a regulatory position or undertake a
substantial further inquiry;
(a)
For example, incomplete or inaccurate information associated with an
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NRC Enforcement Policy
ITAAC notification letter, submitted in accordance with 10 CFR 52.99, is
submitted. If this information had been complete and accurate, it would
likely have caused the NRC to reject closure of that ITAAC;
2.
A withholding of information or a failure to make a required report occurs. If this
information had been provided or the report been made, it would likely have
caused the NRC to reconsider a regulatory position or undertake a substantial
further inquiry. The following are examples:
(a)
failure to make required notifications and reports pursuant to
10 CFR 50.55(e);
(b)
failure to make a 24-hour notification required by 10 CFR 20.2202(b) or
an immediate notification required by 10 CFR 20.2201(a)(1)(i);
(c)
failure to make any report required by 10 CFR 73.71, “Reporting of
Safeguards Events,” or Appendix G, “Reportable Safeguards Events,” to
10 CFR Part 73, “Physical Protection of Plants and Materials,” or
10 CFR Part 26, “Fitness for Duty Programs,” except for
10 CFR 26.719(d);
(d)
failure to submit an initial NRC Form 241, “Report of Proposed Activities
in Non-Agreement States,” as required by 10 CFR 150.20, “Recognition
of Agreement State Licenses”;
(e)
for materials licensees, failure to make an immediate or 24-hour report or
notification when required; or
(f)
failure to make a report required by 10 CFR 50.72, “Immediate
Notification Requirements for Operating Nuclear Power Reactors,” or
10 CFR 50.73, “Licensee Event Report System,” associated with any
SL III violation;
3.
A programmatic failure to comply with 10 CFR 20.2207, “Reports of Transactions
Involving Nationally Tracked Sources,” occurs;
4.
A 10 CFR Part 50 licensee submits inaccurate or incomplete performance
indicator (PI) data to the NRC. Accurate or complete information would have
caused a PI to change from green to either yellow or red, white to either yellow or
red, or yellow to red; or
5.
A failure to provide the notice required by 10 CFR Part 21, for example:
(a)
An inadequate review or failure to review such that, if an appropriate
review had been made as required, a 10 CFR Part 21 report would have
been required; or
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(b)
d.
A withholding of information or a failure to make a required interim report
by 10 CFR 21.21, “Notification of Failure to Comply or Existence of a
Defect and Its Evaluation,” occurs with careless disregard.
SL IV violations involve, for example:
1.
A licensee fails to make a required report that, had it been submitted, would have
resulted in, for instance, increasing the inspection scope of the next regularly
scheduled inspection;
2.
A licensee fails to make a timely written report as required by
10 CFR 20.2201(b), 20.2204, 20.2206, or 20.2207;
3.
A licensee fails to report an exceedance of the dose constraint established in
10 CFR 20.1101(d);
4.
A licensee fails to report indicators of programmatic weaknesses as required in
10 CFR 26.719(d);
5.
A licensee fails to make a report required by 10 CFR 76.120(d)(2), Appendix A to
10 CFR Part 70, or 10 CFR 70.50(c)(1);
6.
A licensee fails to make a written event report, as required by
10 CFR 70.50(c)(1), Appendix A to 10 CFR Part 70, or 10 CFR 76.120(d)(2);
7.
A materials licensee fails to provide or make a 15-day or 30-day written report or
notification; fails to include all information required by regulation or license
condition in a 15-day or 30-day report or notification; or is late making a report to
the NRC required by 10 CFR 35.3045, “Report and Notification of a Medical
Event,” or 10 CFR 35.3047, “Report and Notification of a Dose to an
Embryo/Fetus or a Nursing Child,” that does not impact the regulatory response
by the NRC;
8.
A licensee fails to make the 30-day notification required by
10 CFR 20.2201(a)(1)(ii) or 10 CFR 20.2203(a);
9.
A licensee fails to make a report required by 10 CFR 50.72 or 10 CFR 50.73;
10.
A failure to identify all applicable reporting codes on a Licensee Event Report
that may impact the completeness or accuracy of other information (e.g.,
performance indicator data) submitted to the NRC;
11.
A 10 CFR Part 50 licensee submits inaccurate or incomplete PI data to the NRC
that would have caused a PI to change from green to white;
12.
A licensee fails to make an interim report required by 10 CFR 21.21(a)(2); or
13.
A materials licensee fails to provide the NRC with a Form 241, where:
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6.10
(a)
the licensed activity is not of a type designated as NRC Priority 1, 2, or 3
inspection (as identified in Enclosure 1 of NRC Manual Chapter 2800);
and
(b)
the licensee has not previously violated the requirement; and
(c)
the facts of the specific case would not have otherwise resulted in the
NRC conducting an onsite inspection; and
(d)
the circumstances of the case generally include either the failure to file an
amended Form 241 for additional work locations of limited scope, or the
failure to provide an initial Form 241 for work of very limited scope and
single occurrence of a few days within NRC jurisdiction (e.g., portable
radiological gauge use).
Discrimination
In certain cases, the severity level of a violation may be escalated based on unique escalating
factors such as whether the adverse action was taken because the employee had contacted the
NRC or whether the applicable NRC employee protection regulation (e.g., 10 CFR 50.7 or
similar NRC employee protection regulations) was deliberately violated. Conversely, the
severity level of a violation of an NRC employee protection regulation may be mitigated to a
lower severity level based on factors unique to the specific facts and circumstances of the case.
a.
SL I violations involve, for example:
1.
2.
b.
An executive-level corporate manager (or equivalent) (which for this definition
includes a site vice president) is the decisionmaker or plays a significant role in
the adverse action decisionmaking process regardless of the severity of the
adverse action, but with at least one of the following escalating factors:
(a)
The adverse action against the employee had a widespread site impact
on other employees’ willingness to raise concerns, or
(b)
The employer failed to take meaningful action to investigate and address
the allegation of discrimination, if such allegation was first raised internally
within the employer’s processes addressing employee concerns; or
A mid- or a senior-level plant manager (or equivalent) or a corporate-level line
manager (or equivalent) is the decisionmaker or plays a significant role in the
adverse action decisionmaking process; the employment action is relatively more
adverse to the employee’s terms, conditions, compensation, or privileges of
employment (e.g., suspension without pay); and either a.1(a) or a.1(b) above is
cited, or other unique factors are present.
SL II violations involve, for example:
1.
An executive-level corporate manager (or equivalent) (which for this definition
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includes a site vice president) is the decisionmaker or plays a significant role in
the adverse action decisionmaking process regardless of the severity of the
adverse action but without an escalating factor present;
c.
d.
2.
A mid- or senior-level plant manager (or equivalent) or a corporate-level line
manager (or equivalent) is the decisionmaker or plays a significant role in the
adverse action decisionmaking process; the employment action is relatively more
adverse to the employee’s terms, conditions, compensation, or privileges of
employment (e.g., suspension without pay); and no escalating factor is present;
3.
A mid- or senior-level plant manager (or equivalent) or a corporate-level line
manager (or equivalent) is the decisionmaker or plays a significant role in the
adverse action decisionmaking process; the employment action is relatively less
adverse to the employee’s terms, conditions, compensation, or privileges of
employment (e.g., verbal counseling); and either a.1(a) or a.1(b) above is cited,
or other unique escalating factors are present; or
4.
A lower level plant manager (or equivalent) or supervisor (or equivalent) is the
decisionmaker or plays a significant role in the adverse action decisionmaking
process; the employment action is relatively more adverse to the employee’s
terms, conditions, compensation, or privileges of employment (e.g., suspension
without pay); and either a.1(a) or a.1(b) above is cited, or other unique escalating
factors are present.
SL III violations involve, for example:
1.
A mid- or senior-level plant manager (or equivalent) or a corporate-level line
manager (or equivalent) is the decisionmaker or plays a significant role in the
adverse action decisionmaking process; the employment action is relatively less
adverse to the employee’s terms, conditions, compensation, or privileges of
employment (e.g., verbal counseling); and no escalating factor is present;
2.
A lower level plant manager (or equivalent) or supervisor (or equivalent) is the
decisionmaker or plays a significant role in the adverse action decisionmaking
process; the employment action is relatively more adverse to the employee’s
terms, conditions, compensation, or privileges of employment (e.g., suspension
without pay); and no escalating factor is present; or
3.
A lower level plant manager (or equivalent) or supervisor (or equivalent) is the
decisionmaker or plays a significant role in the adverse action decisionmaking
process; the employment action is relatively less adverse to the employee’s
terms, conditions, compensation, or privileges of employment (e.g., verbal
counseling); and either a.1(a) or a.1(b) above is cited, or other unique escalating
factor(s) are present.
SL IV violations involve, for example:
1.
A lower level plant manager (or equivalent) or supervisor (or equivalent) is the
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decisionmaker or plays a significant role in the adverse action decisionmaking
process; the employment action is relatively less adverse to the employee’s
terms, conditions, compensation, or privileges of employment (e.g., verbal
counseling); and no escalating factor is present.
6.11
Reactor, Independent Spent Fuel Storage Installation, Fuel Facility, and Special Nuclear
Material Security
a.
SL I violations involve, for example:
b.
c.
1.
The theft, diversion, or act of sabotage involves a formula quantity of special
nuclear material (SNM), spent nuclear fuel or a very significant quantity of other
radioactive material having the potential for substantial impact on the public; or
2.
Any failure of a licensee’s security program as outlined in their security plan or
insider mitigation program results in an act of sabotage against one or more
target sets or target set elements.
SL II violations involve, for example:
1.
An act of radiological sabotage that results in the loss or destruction of a quantity
of SNM of moderate strategic significance or a quantity of other radioactive
material determined equally or similarly significant by the NRC;
2.
The theft, diversion, or act of radiological sabotage involves a quantity of SNM of
moderate strategic significance or a quantity of other radioactive material
determined equally or similarly significant by the NRC, in which one or more
attributes of the security program did not function as required;
3.
A licensee fails to involve its reviewing official in developing an unescorted
access authorization determination or determination of fitness for duty, following
a for-cause action by a licensee that results in an individual’s voluntary or
involuntary loss of employment; or
4.
A licensee fails to maintain the high assurance standard of 10 CFR 73.20 and
10 CFR 73.55.
SL III violations involve, for example:
1.
An insider (e.g., licensee employee, licensee contractor or subcontractor)
attempts an act of radiological sabotage to any radiological material;
2.
The security or insider mitigation program has a failure, but the failure does not
amount to a SL I or II violation that challenges the high assurance standard of
10 CFR 73.20, “General Performance Objective and Requirements,” or
10 CFR 73.55, “Requirements for Physical Protection of Licensed Activities in
Nuclear Power Reactors against Radiological Sabotage;”
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d.
3.
A licensee fails to develop and maintain records concerning the denial of access,
or fails to respond to inquiries concerning denials of access, so that, as a result
of the failure, a person previously denied unescorted access or unescorted
access authorization is improperly granted such access;
4.
A licensee fails to ensure that a licensee-approved contractor or vendor access
authorization program is operating in accordance with regulatory and licensee
requirements;
5.
A licensee fails to complete more than one of the requirements of an access
authorization program before granting an individual unescorted access or
unescorted access authorization;
6.
An individual is assigned to a job task related to implementing the licensee’s
protective strategy without the person being qualified in accordance with
regulatory requirements;
7.
A reviewing official relies on a deliberate falsification of information to make an
unescorted access or unescorted access authorization determination;
8.
The safeguards or security systems designed or used to prevent, detect, or
assess, and respond to the theft, loss, or diversion of strategic SNM, or
significant quantities of other radioactive material, experiences a significant
failure; or
9.
A licensee fails to conduct a search or conducts an inadequate search at any
protected area access control point, and this failure results in the introduction of
firearms, explosives, or incendiary devices or reasonable facsimiles thereof that
could assist in committing radiological sabotage or theft or diversion of strategic
SNM.
SL IV violations involve, for example:
1.
A failure of the licensee security or insider mitigation program, as outlined in a
licensee’s security plan, results in an attempted act of radiological sabotage
against one or more target set elements; or
2.
A loss of SNM of low strategic significance or less significant quantities of other
radioactive material was not detected within the time period specified in the
security plan, other relevant document, or regulation.
6.12
Materials Security
a.
SL I violations involve, for example:
1.
The theft, diversion, or sabotage of a Category 1 quantity of radioactive material
results from the failure to establish or implement one or more requirements, such
as the following:
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b.
(a)
failure to control unescorted access to a Category 1 quantity of
radioactive material so that only individuals deemed trustworthy and
reliable and having job duties that require unescorted access to the
radioactive material are granted such access;
(b)
failure to immediately respond (e.g., without undue delay in accordance
with the licensee’s prearranged plan) to an attempted theft, sabotage, or
diversion of a Category 1 quantity of radioactive material, including
requesting assistance from the local law enforcement agency;
(c)
failure to provide enhanced monitoring during periods of source delivery
and shipment of a Category 1 quantity of radioactive material; or
(d)
failure to implement the Radioactive Material Quantities of Concern (RAM
QC) requirements before shipping a consignment containing a Category 1
quantity of radioactive material.
SL II violations involve, for example:
1.
The theft, diversion, or sabotage of a Category 2 quantity of radioactive material
results from the failure to establish or implement one or more increased control
requirements, such as the following:
(a)
failure to control unescorted access to a Category 1 or Category 214
quantity of radioactive material so that only individuals deemed
trustworthy and reliable and having job duties that require unescorted
access to the radioactive material are granted such access;
(b)
failure to immediately respond (e.g., without undue delay in accordance
with the licensee’s prearranged plan) to an attempted theft, sabotage, or
diversion of a Category 1 or Category 2 quantity of radioactive material,
including requesting assistance from the local law enforcement agency;
(c)
shipping a consignment of a Category 2 quantity of radioactive material
by a carrier, other than the licensee, without first verifying that the carrier
uses a package tracking system, implements methods to ensure
trustworthiness and reliability of drivers, maintains constant control and/or
surveillance during transit, and has the capability for immediate
communication to summon appropriate response or assistance;
(d)
failure to provide enhanced monitoring during periods of source delivery
and shipment of a Category 1 quantity of radioactive material;
14
Violation examples 6.12. b. 1. (a), (b), and (f) recognize that a licensee may possess a total of either
Category 1 or Category 2 quantity of radioactive material at the time of the subject incident, but only a Category 2
quantity was actually involved with theft, diversion, or sabotage. Hence, the severity level is determined by the
category of material involved in the theft, diversion, or sabotage.
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c.
(e)
failure to implement the RAM QC Additional Security Measures before
shipping a consignment containing a Category 1 quantity of radioactive
material; or
(f)
failure to use a method to disable a vehicle or trailer, in or on which a
Category 1 or Category 2 quantity of radioactive material is stored, when
not under direct control and constant surveillance by the licensee.
SL III violations involve, for example:
1.
A licensee fails to immediately respond (e.g., without undue delay in accordance
with the licensee’s prearranged plan) to an attempted theft, sabotage, or
diversion of a Category 1 or Category 2 quantity of radioactive material, including
a failure to request assistance from the local law enforcement agency, but the
failure does not result in actual theft, sabotage, or diversion of radioactive
material;
2.
A licensee fails to determine the trustworthiness and reliability of individuals
having unescorted access to radioactive material quantities of concern and
devices;
3.
A licensee fails to limit access to physical protection information to only those
persons with an established need-to-know and who have been determined to be
trustworthy and reliable;
4.
A licensee fails to verify that a carrier uses package tracking systems,
implements methods that ensure trustworthiness and reliability of drivers,
maintains constant control and/or surveillance during transit, and has the
capability for immediate communication to summon appropriate response
or assistance, before shipping a Category 2 quantity of radioactive material, per
consignment, by the carrier;
5.
A licensee fails to provide enhanced monitoring during periods of source delivery
and shipment of a Category 1 quantity of radioactive material;
6.
A licensee fails to initiate an investigation to determine the location of a shipment
of licensed material containing a Category 2 quantity of radioactive material when
the shipment does not arrive on or about the expected arrival time;
7.
A licensee fails to notify the NRC Operations Center promptly after initiating a
response to any actual or attempted theft, diversion, or sabotage of sources or
devices containing a Category 1 or Category 2 quantity of radioactive material;
8.
A licensee fails to implement the RAM QC before shipping a Category 1 quantity
of radioactive material, per consignment;
9.
A licensee fails to use a method to disable a vehicle or trailer, in or on which a
Category 1 or Category 2 quantity of radioactive material is stored, when not
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under direct control and constant surveillance by the licensee;
d.
10.
A licensee fails to contact the local law enforcement agency and does not
attempt to establish a prearranged response plan with the local law enforcement
agency, or a programmatic failure occurs in the implementation of the plan;
11.
A licensee fails to establish a program to monitor and immediately detect,
assess, and respond to unauthorized access to a Category 1 or Category 2
quantity of radioactive material, or a programmatic failure occurs during
implementation;
12.
A licensee fails to have a dependable means to transmit information between
and among the various components of the intrusion detection system or to
summon the appropriate responder; or
13.
A licensee fails to verify that a recipient licensee is authorized to possess the
material being transferred.
SL IV Violations involve, for example:
1.
A licensee fails to document the basis for concluding that an individual was
determined to be trustworthy and reliable for the purposes of granting unescorted
access to a Category 1 or Category 2 quantity of radioactive material;
2.
A licensee fails to perform a complete and adequate trustworthiness and
reliability determination for an individual, such that information relevant to access
approval was not obtained or considered, but the individual would likely have
been granted unescorted access if the required information had been obtained or
considered;
3.
A licensee fails to limit approval for unescorted access with respect to a
Category 1 or Category 2 quantity of radioactive material to individuals with job
duties requiring unescorted access;
4.
A licensee fails to maintain a list of persons approved for unescorted access;
5.
A licensee fails to confirm receipt of transferred/shipped radioactive material;
6.
A licensee fails to document the prearranged plan with the local law enforcement
agency or to update the prearranged plan when changes to the facility design or
operation affect the potential vulnerability of sources;
7.
An isolated failure occurs in the as-designed operation of the dependable means
to transmit information between and among the various components of the
intrusion detection system or to summon the appropriate responder. This is a
violation if caused by a failure of the licensee in the design, construction,
operation, or maintenance of the system. (This example does not include
isolated failures caused by means outside the licensee’s control, such as service
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disruptions;)
8.
A licensee fails to contact the recipient or originator of a shipment to coordinate
an expected arrival time for a shipment of a Category 2 quantity of radioactive
material;
9.
An isolated failure occurs in implementing a portion of the licensee’s program to
monitor and immediately detect, assess, and respond to unauthorized access to
a Category 1 or Category 2 quantity of licensed radioactive material, such that an
opportunity exists for unauthorized and undetected access to the material, but
the opportunity is neither easily nor likely to be exploitable;
10.
An isolated failure occurs in limiting access to physical protection information to
only those persons with an established need-to-know and who are considered
trustworthy and reliable, where with a high degree of confidence it is determined
to be unlikely that an unauthorized individual who represents a predictable threat
to circumvent or defeat the licensee’s physical protection program could use the
information; or
11.
A licensee fails to comply with an element of its procedure to provide enhanced
monitoring during periods of source delivery and shipment of a Category 1
quantity of radioactive material, and this failure does not seriously degrade the
enhanced monitoring capability.
6.13
Information Security
a.
SL I violations involve, for example:
1. Failure to control TOP SECRET or SECRET matter where the matter is removed
from a controlled area (i.e., an area controlled for the use of classified material) by,
or disclosed to, an unauthorized person.
b.
c.
SL II violations involve, for example:
1.
Failure to control TOP SECRET or SECRET matter results in the removal of the
matter from a controlled area (i.e., an area controlled for the use of classified
material) with the possibility that the matter could have been disclosed to an
unauthorized person; or
2.
Failure to control CONFIDENTIAL classified matter, Safeguards Information
(SGI), or Safeguards Information-Modified Handling (SGI-M) results in the matter
or information being removed from a controlled area (i.e., an area controlled for
the use of classified material) and disclosed to an unauthorized person.
SL III violations involve, for example:
1.
Because of failure to control classified matter, SGI (including SGI-M), there is a
substantial potential that the matter or information could have been removed
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from a controlled area (i.e., an area controlled for the use of classified material)
by or disclosed to an unauthorized person; or
2.
d.
A licensee fails to protect, control, or mark classified matter, SGI (including
SGI-M) while the matter or information is outside the protected area and
accessible to those not authorized access to the protected area.
SL IV violations involve, for example:
1.
A failure to properly secure, protect, or mark classified matter, SGI (including
SGI-M) inside the protected area in a case where the matter or information was
not removed from the protected area.
6.14
Fitness for Duty15
a.
SL I violations involve, for example:
b.
c.
15
1.
A licensee fails to substantially implement or substantially maintain reasonable
assurance of fitness-for-duty program performance in two or more subparts of
10 CFR Part 26; or
2.
A licensee fails to substantially implement a licensee employee assistance
program (EAP).
SL II violations involve, for example:
1.
A licensee fails to remove an individual from unescorted access status when this
person has been involved in the sale, use, or possession of illegal drugs within
the protected area, or a licensee fails to take action in the case of an on-duty
misuse of alcohol, illegal drugs, prescription drugs, or over-the-counter
medications; or
2.
A licensee fails to take action to meet a regulation or a licensee behavior
observation program requirement when observed behavior within the protected
area or credible information concerning the activities of an individual indicates
possible unfitness for duty based on drug or alcohol use.
SL III violations involve, for example:
1.
A licensee fails to take the required action for a person confirmed to have tested
positive for illegal drug use or to take action for onsite alcohol use, in cases that
do not amount to a SL II violation;
2.
A licensee fails to ensure that a licensee-approved contractor’s or vendor’s
fitness-for-duty program is operating in accordance with regulatory and licensee
requirements;
See Section 6.4 for examples of fitness-for-duty violations specific to licensed reactor operators.
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d.
6.15
3.
A licensee fails to complete or maintain more than one of the requirements of a
program for individuals listed in 10 CFR 26.4, “FFD Program Applicability to
Categories of Individuals;”
4.
A licensee fails to develop and maintain records concerning the denial of access
or to respond to inquiries concerning denials of access so that, as a result of the
failure, a person previously denied fitness-for-duty authorization is improperly
granted such access;
5.
A licensee’s EAP staff fails to notify licensee management when the EAP staff is
aware that an individual’s condition may adversely affect the safety or security of
the facility; or
6.
A individual covered by 10 CFR Part 26, Subpart I, involved in a human error
that caused or contributed to an actual event or a potential degradation of the
level of safety of the plant, who at the time the error occurred, was determined to
be fatigued as a result of a fatigue assessment as defined in 10 CFR 26.211.
SL IV violations involve, for example:
1.
Failure to prepare, implement, and maintain written procedures that describe the
methods to be used implementing the FFD policy;
2.
A licensee fails to take an action required by the licensee’s behavior observation
program in cases that do not amount to a SL I, II, or III violation; or
3.
Failures to appropriately implement any of the requirements (e.g., work hours,
waivers, self declarations, or fatigue assessment) of 10 CFR Part 26, Subpart I
that do not result in an actual event or a degradation of a level of safety, but are
more than minor in that they are not isolated or demonstrate programmatic
weaknesses in implementation.
Export and Import Activities
Several of the following violation examples involve deliberateness or careless disregard.
For those examples, the normal Enforcement Policy process for discretion to potentially
escalate the severity level of the violation based on willfulness is not necessary.
a.
SL I violations involve, for example:
1.
Deliberate misrepresentation of facts, with the knowledge of a licensee
official, that led to the export of licensable and sensitive equipment or
material in quantities of concern to a destination that, if represented
accurately, would not have been authorized by the NRC (or other
authority); or
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2.
b.
c.
d.
Deliberate misrepresentation of facts that led to unauthorized individuals
obtaining sensitive nuclear equipment or materials in quantities of
concern.
SL II violations involve, for example:
1.
Failure to provide notice of 10 CFR Part 110, Appendix P, material import
as required by 10 CFR 110.50 that, if the notice had been provided,
would have prompted the NRC to take action to block the import;
2.
Misrepresentation of facts in careless disregard of requirements, with the
knowledge of a licensee official, for the export or import of radioactive or
byproduct materials, such as those involving the completeness or
accuracy of the information that, if represented accurately, would not
have been authorized by the NRC (or other authority); or
3.
Inaccurate or incomplete information provided or maintained that led to
unauthorized individuals possessing radioactive materials. If this
information had been completely and accurately provided or maintained,
it would likely have caused the NRC to terminate or deny a license, to
issue an Order requiring suspension or cessation of licensed activity, or
to take action to block an export or import, to protect the public health and
safety or common defense and security.
SL III violations involve, for example:
1.
Failure to submit timely notification of the import of 10 CFR part 110,
Appendix P material, as required by 10 CFR 110.50, where, if this
information had been provided, it would likely have caused the NRC to
take further action or inquiry;
2.
Inaccurate or incomplete information on exports or imports of radioactive
or byproduct materials such that, if the information had been represented
accurately, it would likely have resulted in the NRC reconsidering the
authorization of the activity, issuing a request for additional information
(RAI), or conducting an inspection to resolve the matter;
3.
Export of byproduct material identified in 10 CFR part 110, Appendix P, to
individuals or entities not authorized to receive such materials; or
4.
Failure to obtain a specific license before the export or import of any NRC
licensable equipment, special nuclear material, and source or byproduct
materials, when required.
SL IV violations involve, for example:
1.
Failure to submit timely reports as specified in 10 CFR 110.54;
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7.0
2.
Export or import of nuclear equipment or materials in excess of the limits
specified in a specific license or license amendment, when such activity
would have been authorized by the NRC (or other authority); or
3.
Unauthorized export of foreign-obligated material or equipment in
violation of 10 CFR 110.50(b)(3) requirements.
GLOSSARY
This glossary, while not exhaustive, contains many of the terms commonly used throughout the
NRC enforcement process.
Activity Area refers to the area of NRC-licensed activity that a licensee (or other person)
engages in (e.g., radiography, reactor operations).
Actual Consequences include such effects as actual, exposures to workers or members of the
public exceeding regulatory limits (e.g.,10 CFR 20.1201, ”Occupational Dose Limits for Adults”
and 10 CFR 20.1301, “Dose Limits for Individual Members of the Public”), onsite or offsite
releases of material exceeding regulatory or license limits, accidental criticality, core damage,
loss of significant safety barriers, and loss of control of radioactive material.
Adverse Action is any action that may adversely impact the compensation, terms, conditions,
or privileges of employment including but not limited to a failure to receive a routine annual pay
increase or bonus; demotion or arbitrary downgrade of a position; transfer to a position that is
recognized to have a lesser status or be less desirable (e.g., from a supervisory to
nonsupervisory position); failure to promote; overall performance appraisal downgrade; verbal
or written counseling, or other forms of constructive discipline.
Alternative Dispute Resolution (ADR) refers to a variety of processes that emphasize
creative, cooperative approaches to handling conflicts in lieu of adversarial procedures.
Mediation and arbitration are the most widely recognized processes. The NRC’s ADR program
uses mediation rather than arbitration (i.e., the parties develop mutually agreeable corrective
actions rather than being obligated by an arbitrator’s decision).
Apparent Violation is a situation or circumstance that does not appear to meet NRC
requirements and for which the NRC staff has not made a final enforcement determination.
Careless Disregard refers to situations in which an individual acts with reckless indifference to
at least one of three things: (1) the existence of a requirement, (2) the meaning of a
requirement, or (3) the applicability of a requirement. Careless disregard occurs when an
individual is unsure of the existence of a requirement, the meaning of a requirement, or the
applicability of the requirement to the situation, but nevertheless proceeds to engage in conduct
that the individual knows may cause a violation. Although aware that the action might cause a
violation, the individual proceeds without first ascertaining whether a violation would occur.
Certificate Holder is any person or entity that has been issued a certificate by the NRC.
Certificate holders include, but are not limited to, those issued certificates in accordance with
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the requirements of 10 CFR Parts 32, 71, or 76. For the purposes of this Policy, where not
addressed specifically, Certificate Holders are typically handled the same as Licensees.
Civil Penalty is a monetary penalty that may be imposed for violations of (1) certain specified
provisions of the AEA or supplementary NRC rules or Orders, (2) any requirements for which a
license may be revoked, or (3) reporting requirements under Section 206 of the ERA.
Confirmatory Action Letter (CAL) is a letter confirming a licensee’s or contractor’s agreement
to take certain actions to remove significant concerns regarding health and safety, safeguards,
or the environment.
Confirmatory Order is an Order that confirms the commitments made by a license or individual
to take certain actions. Before issuance of the Confirmatory Order, the licensee or individual
and the NRC mutually agree on the terms of the Order.
Contractor, as used in this Policy, includes vendors who supply products or services to be used
in an NRC-licensed facility or activity.
Corrective Action Program is a licensee’s process for tracking, evaluating, and resolving
deficiencies.
Deliberate Misconduct occurs when an individual voluntarily and intentionally (1) engages in
conduct that the individual knows to be contrary to a requirement, procedure, instruction,
contract, purchase order, or policy of a licensee, applicant for a license, or a contractor or
subcontractor of a licensee or applicant for a license or (2) provides materially inaccurate or
incomplete information to a licensee, applicant for a license, or a contractor or subcontractor of
a licensee or applicant for a license.
Demand for Information (DFI), as defined in 10 CFR 2.204, requires a licensee or other
person subject to the jurisdiction of the Commission to respond with specific information for the
purpose of enabling the NRC to determine whether an Order should be issued or whether other
action should be taken.
Discrimination, as described in 10 CFR 50.7 (or similar provisions in 10 CFR Parts 30, 40, 52,
60, 61, 63, 70, 71, 72, and 76), is the taking of an adverse action against an employee because
the employee engaged in certain protected activities.
Escalated Enforcement Actions include SL I, II, and III NOVs; NOVs associated with an
inspection finding that the SDP evaluates as having low to moderate (white) or greater safety
significance; civil penalties; NOVs to individuals; Orders to modify, suspend, or revoke NRC
licenses or the authority to engage in NRC-licensed activities; and Orders issued to impose civil
penalties.
Event, as used in this Policy, means (1) an occurrence characterized by an active adverse
impact on equipment or personnel, readily obvious by human observation or instrumentation, or
(2) a radiological impact on personnel or the environment in excess of regulatory limits, such as
an overexposure, a release of radioactive material above NRC limits, or a loss of radioactive
material. For example, an equipment failure discovered through a spill of liquid, a loud noise,
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NRC Enforcement Policy
the failure of a system to respond properly, or an annunciator alarm would be considered an
event; a system discovered to be inoperable through a document review would not. Similarly, if
a licensee discovers, through quarterly dosimetry readings, that employees had been
inadequately monitored for radiation, the issue would normally be considered licensee identified;
however, if the same dosimetry readings disclose an overexposure, the issue would be
considered an event.
Fuel Cycle is the series of steps involved in supplying fuel for nuclear power reactors. It can
include mining, milling, isotopic enrichment, fabrication of fuel elements, use in a reactor,
chemical reprocessing to recover the fissionable material remaining in the spent fuel,
reenrichment of the fuel material, refabrication into new fuel elements, waste disposal, storage,
and transportation.
Impacts the NRC’s Ability To Perform Its Regulatory Function refers to a situation that
prevents the NRC from using appropriate regulatory tools to address a noncompliance because
the Agency is unaware that the noncompliance exists (e.g., provision of inaccurate and
incomplete information or failure to submit a required report).
License Applicant, as used in this statement of policy, means any person who submits an
application for review.
Licensee is any person or entity authorized to conduct activities under a license issued by the
NRC.Licensees include, but are not limited to, facilities licensed under 10 CFR Parts 30-36, 39,
40, 50, 52, 60, 61, 63, 70 or 72. However, in most cases in the Policy the term is applied
broadly to refer to any or all of entities listed in Section 1.2, “Applicability.”
Licensee Official, as used in this statement of policy, in general, means a first-line supervisor
or above, a licensed individual, a radiation safety officer, or an authorized user of licensed
material whether or not listed on a license. Notwithstanding an individual’s job title, the NRC will
consider the individual’s responsibilities relative to the oversight of licensed activities and the
use of licensed material.
Licensed Reactor Operator, as used in this Policy, includes NRC licensed reactor operators
(ROs) and NRC licensed senior reactor operators (SROs).
Lost Source Policy is the NRC’s policy that a civil penalty may be issued for violations
resulting in regulated material being out of the control of the licensee regardless of the use,
license type, quantity, or type of regulated material (e.g., loss, abandonment, improper transfer,
or improper disposal of regulated material).
Minor Violation is a violation that is less significant than a SL IV violation. Minor violations do
not warrant enforcement action and are not normally documented in inspection reports.
However, minor violations must be corrected.
Noncited Violation (NCV) is a nonrecurring, typically nonwillful, SL IV violation or a violation
associated with a Green ROP finding that is not subject to formal enforcement action if, for a
reactor licensee, the licensee places the violation in a corrective action program to address
recurrence and restores compliance within a reasonable period of time and, for all other
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licensees, the licensee corrects or commits to correcting the violation within a reasonable period
of time.
Nonescalated Enforcement Actions include NOVs that are dispositioned by the NRC as SL IV
or minor violations.
Nonlicensee includes, but is not limited to, applicants, contractors, subcontractors, and
vendors.
Notice of Deviation (NOD) is a written notice describing a licensee’s failure to satisfy a
commitment where the commitment involved has not been made a legally binding requirement.
An NOD requests that a licensee provide a written explanation or statement describing
corrective steps taken (or planned), the results achieved, and the date when corrective action
will be completed.
Notice of Nonconformance (NON) is a written notice describing the failure of a licensee’s
contractor to meet commitments that have not been made legally binding requirements by the
NRC (e.g., a commitment made in a procurement contract with a licensee or applicant as
required by 10 CFR Part 50, Appendix B). (If the contractor deliberately fails to meet the terms
of a procurement contract, the NRC may issue a violation under the Deliberate Misconduct Rule
in 10 CFR 50.5.) NONs request that nonlicensees provide written explanations or statements
describing corrective steps (taken or planned), the results achieved, the dates when corrective
actions will be completed, and measures taken to preclude recurrence.
Notice of Violation (NOV) is a written notice setting forth one or more violations of a legally
binding requirement (see 10 CFR 2.201).
Order is used to modify, suspend, or revoke a license, or to take other action against a licensee
or other person subject to the jurisdiction of the Commission (see 10 CFR 2.202).
Potential Safety or Security Consequences include potential outcomes based on realistic and
credible scenarios (i.e., the staff considers the likelihood that safety or security could have been
negatively impacted under these scenarios).
Predecisional Enforcement Conference (PEC) is normally conducted with a licensee or
individual before the NRC makes an enforcement decision when escalated enforcement action
may warranted (i.e., SL I, II, or III violations, civil penalties, or Orders). The purpose of a PEC is
to obtain information that will assist the NRC in determining the appropriate enforcement action,
if any.
Regulatory Conference is conducted with a reactor licensee to discuss the significance of
findings evaluated through the SDP, with or without associated violations. These meetings
focus on the safety significance of the issues and not necessarily on the corrective actions
associated with the issues. Because the significance assessment from the SDP determines
whether escalated enforcement action will be taken, a subsequent PEC is not normally
necessary.
Requirement, as used in this Policy, means a legally binding requirement such as a statute,
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regulation, license condition, technical specification, or Order.
Repetitive Violation is one that could reasonably be expected to have been prevented by a
licensee’s corrective action for the same, or a similar, previous violation or a previous licensee
finding that occurred within the past 2 years of the current violation, or that occurred within the
period covered by the last two inspections, whichever period is longer.
Risk Information is used wherever possible to develop realistic and credible scenarios to use
when assessing the safety significance of a violation and assigning severity levels.
Severity Levels are used (1) to indicate the significance of a violation assessed under
traditional enforcement and (2) to determine the appropriate enforcement action to be taken.
Significance, as used in this Policy for violations that do not involve application of the ROP,
describes the seriousness of the violation. The significance of violations assessed under the
ROP is determined by the SDP, described in IMC 0609 and related documents.
Substantial Potential for Overexposure describes a situation where it was fortuitous that the
resulting radiation exposure did not exceed the dose limits of 10 CFR Part 20. The concern is
not the significance of the resulting or potential exposure, but whether the licensee provided
adequate controls over the situation, as required, to prevent exceedance of the 10 CFR Part 20
limits.
Traditional Enforcement, as used in this Policy, refers to the process for the disposition of
violations of NRC requirements, including those that cannot be addressed only through the
Operating Reactor Assessment Program. Traditional enforcement violations are assigned
severity levels and typically include, but may not be limited to, those violations involving
(1) actual safety and security consequences, (2) willfulness, (3) impeding the regulatory
process, (4) discrimination, (5) issues for which no ROP performance deficiency can be
identified, (6) materials regulations, and (7) deliberate violations committed by individuals.
Violation is the failure to comply with a requirement.
Willful violations involve either a deliberate violation of NRC requirements or deliberately
falsifying information, or careless disregard of NRC requirements or of the completeness and
accuracy of information provided.
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8.0
TABLE OF BASE CIVIL PENALTIES
TABLE A
______________________________________________________________________
a.
Power reactors, gaseous diffusion uranium enrichment plants, and
high-level waste repository ....................................................................... $140,000
b.
Fuel fabricators authorized to possess Category I
or II quantities of SNM and uranium conversion facilities ........................... $70,000
c.
All other fuel fabricators, including facilities under construction,
authorized to possess Category III quantities of SNM, industrial processors,1
independent spent fuel and monitored retrievable storage installations, mills,
gas centrifuge and laser uranium enrichment facilities............................... $35,000
d.
Test reactors, contractors, waste disposal licensees, industrial
radiographers, and other large material users............................................ $14,000
e.
Research reactors, academic, medical,
or other small material users2 ....................................................................... $7,000
f.
Loss, abandonment, or improper transfer or disposal of regulated
material, regardless of the use or type of licensee3:
1. Sources or devices with a total activity greater than
3.7 × 104 MBq (1 Curie), excluding
hydrogen-3 (tritium) ................................................................................ $54,000
2. Other sources or devices containing the materials and quantities
listed in 10 CFR 31.5(c)(13)(i) ................................................................ $17,000
3. Sources and devices not otherwise described above .............................. $7,000
g.
Individuals who release safeguards information .......................................... $3,500
_______________________________
1
2
3
Large firms engaged in manufacturing or distribution of byproduct, source, or special nuclear material.
This applies to nonprofit institutions not otherwise categorized in this table, mobile nuclear services, nuclear
pharmacies, and physician offices.
These base civil penalty amounts have been determined to be approximately 3 times the average cost of
disposal. For specific cases, the NRC may adjust these amounts to correspond to 3 times the estimated or
actual cost of authorized disposal for the particular material in question.
TABLE B
______________________________________________________________________
Severity Level
Base Civil Penalty Amount
(Percent of amount listed in Table A)
I ………………………………………………… 100%
II………………………………………………......80%
III………………………………………………….50%
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9.0
INTERIM ENFORCEMENT POLICIES
9.1
Enforcement Discretion for Certain Fire Protection Issues (10 CFR 50.48)
This section contains the interim Enforcement Policy that the NRC will follow to exercise
enforcement discretion for certain noncompliances with the requirements in Title 10 of the Code
of Federal Regulations (10 CFR) 50.48, “Fire Protection” (or fire protection license conditions),
that are identified as a result of a licensee’s transition to the new risk-informed, performancebased fire protection approach included in 10 CFR 50.48(c) and for certain existing identified
noncompliances that reasonably may be resolved by compliance with 10 CFR 50.48(c). Under
10 CFR 50.48(c), reactor licensees may voluntarily comply with the risk-informed, performancebased fire protection approaches in National Fire Protection Association Standard 805,
“Performance-Based Standard for Fire Protection for Light Water Reactor Electric Generating
Plants” (NFPA 805), 2001 Edition (with limited exceptions stated in the rule language).
Enforcement discretion may apply to noncompliances identified during the licensee transition
process. This timeframe starts on the date as specified in the licensee’s letter of intent to
transition to 10 CFR 50.48(c) and ends (1) 3 years after that initial start date or (2) on the date
as specified in the licensee’s commitment letter, as amended and approved by the NRC. If the
licensee is unable to submit its license amendment request (LAR) within the timeframe stated
above, it will lose its enforcement discretion. However, licensees with appropriate justification
and staff approval may regain enforcement discretion once an acceptable16 LAR is submitted. If
enforcement discretion is not granted, any identified noncompliances may be subject to
enforcement action.
Once an acceptable LAR is submitted, enforcement discretion for previously identified
noncompliances17 and any newly identified noncompliances discovered either by the licensee or
the NRC while the LAR is under review will continue to be in place until the NRC dispositions
the LAR.18 If the NRC finds the amendment request unacceptable but gives the licensee an
opportunity to provide supplemental information, the enforcement discretion will continue while
the licensee prepares the supplemental information, provided that it submits the information
within the timeframe stipulated by the staff. If the NRC finds the amendment acceptable after
receipt of the supplemental information, enforcement discretion will continue until the NRC
dispositions the amendment. A licensee that submits an LAR that is not acceptably
supplemented or an LAR that was initially characterized as unacceptable with no opportunity to
provide supplemental information will lose its enforcement discretion. However, licensees with
appropriate justification and NRC approval may regain enforcement discretion once an
acceptable LAR is submitted. If enforcement discretion is not granted, any indentified
noncompliances may be subject to enforcement action.
16
The agency will use the Office of Nuclear Reactor Regulation’s (NRR) Office Instruction, LIC-109,
“Acceptance Review Procedures,” to evaluate the LAR for acceptability.
17
These are noncompliances that were previously granted enforcement discretion before submittal of the LAR.
18
Noncompliances that are identified during the LAR review process and that are determined to be either
associated with a finding of high safety significance or willful will be considered for potential enforcement
action.
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NRC Enforcement Policy
Once the NRC accepts an LAR for licensing review, the timeliness and quality of the responses
to requests for additional information (RAI) will significantly affect the LAR review schedule.
Licensees that do not respond in a timely fashion to staff RAIs or do not provide quality RAI
responses may lose enforcement discretion.
If, after submitting the letter of intent to comply with 10 CFR 50.48(c) and before submitting the
LAR , a licensee decides not to complete the transition to 10 CFR 50.48(c), the licensee must
submit a letter stating its intent to retain its existing licensing basis and withdrawing its letter of
intent to comply with 10 CFR 50.48(c). After the licensee’s withdrawal from the transition
process, the NRC, as a matter of practice, will not take enforcement action against any
noncompliance that the licensee corrected during the transition process and will, on a case-bycase basis, consider refraining from taking action if reasonable and timely corrective actions are
in progress (e.g., an exemption has been submitted for NRC review). The NRC will disposition
noncompliances that the licensee has not corrected, and noncompliances that were identified
after the date of the withdrawal letter, in accordance with normal enforcement practices.
a.
Noncompliances Identified During the Licensee’s Transition Process
Under this interim Enforcement Policy, the NRC will normally not take enforcement
action for a violation of 10 CFR 50.48(b) (or the requirements in a fire protection license
condition) involving a problem in an area such as engineering, design, implementing
procedures, or installation if the violation is documented in an inspection report and
meets all of the following criteria:
1.
The licensee identified the violation as a result of a voluntary initiative to adopt
the risk-informed, performance-based fire protection program under
10 CFR 50.48(c), or, if the NRC identified the violation, the NRC found it likely
that the licensee would have identified the violation in light of the defined scope,
thoroughness, and schedule of its transition to 10 CFR 50.48(c).
2.
The licensee corrected the violation or will correct the violation after completing
its transition to 10 CFR 50.48(c). Also, the licensee took immediate corrective
action or compensatory measures or both within a reasonable time
commensurate with the risk significance of the issue following identification; this
action should involve expanding the initiative, as necessary, to identify other
issues caused by similar root causes.
3.
Routine licensee efforts, such as normal surveillance or quality assurance
activities, were not likely to have previously identified the violation.
4.
The violation was not willful.
The NRC may take enforcement action when the licensee has not met these conditions
or when a violation that is associated with a finding of high safety significance is
identified.
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NRC Enforcement Policy
Although the NRC may exercise discretion for violations meeting the required criteria, if
the licensee failed to make a required report to the agency, then it will normally issue a
separate enforcement action for the licensee’s failure to make the required report.
b.
Existing Identified Noncompliances
In addition, the licensee may have existing identified noncompliances that could
reasonably be corrected under 10 CFR 50.48(c). For these noncompliances, the NRC is
providing enforcement discretion for the implementation of corrective actions until the
licensee has made the transition to 10 CFR 50.48(c), provided that the noncompliances
meet all of the following criteria:
9.2
1.
The licensee has entered the noncompliance into its corrective action program
and implemented appropriate compensatory measures.
2.
The noncompliance is not associated with a finding that the Reactor Oversight
Process significance determination process would evaluate as red, or otherwise
it would not be categorized at Severity Level I.
3.
The noncompliance was not willful.
4.
The licensee submitted a letter of intent by December 31, 2005, stating its intent
to transition to 10 CFR 50.48(c).
Enforcement Discretion for Permanent Implant Brachytherapy Medical Event
Reporting (10 CFR 35.3045)
This section sets forth the interim policy that the NRC will use for medical event reporting
violations under current 10 CFR 35.3045. Enforcement discretion will typically be exercised for
reporting violations in the following scenarios, subject to criteria specified below, when the
authorized treatment mode is permanent implant brachytherapy: (1) the licensee uses total
source strength and exposure time for evaluating the existence of a treatment site medical
event; or (2) the total absorbed dose to the treatment site equals or exceeds 120 percent of the
prescribed dose. This policy does not provide regulatory relief from complying with any other
aspect of §§ 35.41 or 35.3045, including the requirements related to the evaluation of dose to
normal tissue.
The interim policy applies to violations that result from an otherwise appropriate use of total
source strength and exposure time when determining the existence of a medical event and
when the use of these values does not result in the misapplication of byproduct material by the
licensee.
Specifically, under this interim Enforcement Policy, the NRC will normally not take enforcement
action for using total source strength and exposure time to compare the dose delivered to the
treatment site with the prescribed dose when evaluating whether a medical administration is a
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NRC Enforcement Policy
medical event under § 35.3045(a)(1) if the authorized treatment mode is permanent implant
brachytherapy and all of the following criteria are met:
a.
The licensee's documented procedures required under § 35.41 specify total
source strength and exposure time as the regulatory evaluation values for
treatment site dose comparisons;
b.
The licensee entered both the prescribed dose and the delivered dose into the
written directive as total source strength and exposure time; and
c.
Per § 35.3045, the licensee timely reported the event based on that treatment
site dose comparison, if applicable.
In addition, the NRC will normally not take enforcement action against a licensee for not
submitting a medical event report when the permanent implant brachytherapy treatment site
total dose equals or exceeds 120 percent of the prescribed dose. This enforcement discretion
would only apply if: (1) the licensee used absorbed dose to compare the dose delivered to the
treatment site with the prescribed dose; (2) doses to normal tissues and structures did not
exceed the regulatory dose limits for reporting medical events specified in current
§ 35.3045(a)(3); and (3) the total dose for the treatment site was expressed in the written
directive as absorbed dose.
This discretion will not be exercised for licensees using source strength and exposure time to
compare the dose delivered to the treatment site with the prescribed dose, since it is expected
that the licensee has more control over delivery of the prescribed dose when using source
strength and exposure time. However, this is not intended to limit the physician’s current ability
to make intraoperative adjustments in the quantity of source strength to be implanted based on
the conditions encountered during the surgical procedure and to document such adjustments in
the portion of the written directive required after implantation but before completion of the
procedure.
Licensees shall comply with all other requirements, as applicable, unless explicitly replaced or
amended in this interim policy.
This interim policy will remain in place until the implementation date of a final rule associated
with the medical event reporting requirements.
10.0
PAPERWORK REDUCTION ACT STATEMENT and PUBLIC PROTECTION
NOTIFICATION
Paperwork Reduction Act Statement
This policy statement contains information collection requirements that are subject to the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These information collections were
approved by the Office of Management and Budget (OMB), approval number 3150-0136. This
policy statement references additional mandatory and voluntary information collections
approved by OMB, approval numbers 3150-0002, 3150-0007, 3150-0008, 3150-0009, 31500010, 3150-0011, 3150-0013, 3150-0014, 3150-0016, 3150-0017, 3150-0018, 3150-0032,
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NRC Enforcement Policy
3150-0035, 3150-0036, 3150-0104, 3150-0146, 3150-0151, 3150-0158, 3150-0195.
The burden to the public for the voluntary information collections approved under clearance
number 3150-0136 is estimated to average 166 hours per NOED request and 40 hours per
NFPA 805 letter of intent, including the time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the
information collection. The information provided in a NOED request is needed for the NRC to
determine if the exercise of enforcement discretion is clearly consistent with protecting the
public health and safety. The information in a letter of intent to transition to NFPA 805 is
needed to determine when the licensee’s three years of enforcement discretion begins. Send
comments regarding this burden estimate or any other aspect of these information collections,
including suggestions for reducing the burden, to the Information Services Branch (T-5 F53),
U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by email to
[email protected]; and to the Desk Officer, Office of Information and Regulatory
Affairs, NEOB-10202, (3150-0136), Office of Management and Budget, Washington, DC 20503.
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 document displays a
currently valid OMB control number.
84
| File Type | application/pdf |
| File Title | Revised NRC Enforcement Policy Incorporating Interim Enforcement Policy for Permanent Implant Brachytherapy Medical Event Report |
| File Modified | 2013-08-23 |
| File Created | 2013-08-23 |