[Federal Register Volume 64, Number 216 (Tuesday, November 9, 1999)]
[Notices]
[Pages 61142-61167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28595]
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NUCLEAR REGULATORY COMMISSION
[NUREG-1600]
Revision of the NRC Enforcement Policy
AGENCY: Nuclear Regulatory Commission.
ACTION: Policy Statement: revision.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is publishing a
complete revision of its General Statement of Policy and Procedure for
NRC Enforcement Actions (NUREG-1600) (Enforcement Policy or Policy).
This is the third complete revision of the Enforcement Policy since it
was first published as a NUREG document on June 30, 1995; 60 FR 34381.
The NRC publishes the policy statement as a NUREG to foster its
widespread dissemination. This revision: (1) Revises the approach for
assessing the significance of violations; (2) Changes guidance to
conform to recent revisions to the NRC's regulations for operating
reactors regarding changes, tests, and experiments (64 FR 53582;
October 4, 1999); (3) Updates the Policy to reflect the Deputy
Executive Director for Reactor Programs and the Deputy Executive
Director for Materials, Research and State Programs as the principal
enforcement officers of the NRC; (4) Corrects the schedule for
exercising enforcement discretion for findings involving the
completeness and accuracy of licensee Final Safety Analysis Reports
(FSAR); (5) Consolidates the guidance on dispositioning Severity Level
IV violations as either Notices of Violation or Non-Cited Violations;
(6) Reorganizes existing guidance on the relationship between safety
and compliance to improve clarity; (7) Consolidates changes to the
Enforcement Policy since May 1998; and (8) Edits and restructures
existing guidance to assure consistency with recent policy changes and
to facilitate maintenance of the Enforcement Policy. The intent of this
Policy revision is to move towards a more risk-informed and
performance-based approach.
DATES: This action is effective November 9, 1999. Comments on this
revision should be submitted on or before December 9, 1999 and will be
considered by the NRC prior to the next Enforcement Policy revision.
ADDRESSES: Submit written comments to: David L. Meyer, Chief, Rules and
Directives Branch, Division of Administrative Services, Office of
Administration, Mail Stop: T6D59, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001. Hand deliver comments to: 11555 Rockville
Pike, Maryland, between 7:30 a.m. and 4:15 p.m., Federal workdays.
Copies of comments received may be examined at the NRC Public Document
Room 2120 L Street, NW. (Lower Level), Washington, DC.
The NRC's Office of Enforcement maintains the current policy
statement on its homepage on the Internet at www.nrc.gov/OE/.
FOR FURTHER INFORMATION CONTACT: Bill Borchardt, Director, Office of
Enforcement, (301) 415-2741, or Renee Pedersen, Senior Enforcement
Specialist, Office of Enforcement, U.S.
[[Page 61143]]
Nuclear Regulatory Commission, Washington, D.C. 20555-0001, (301) 415-
2741.
SUPPLEMENTARY INFORMATION: The NRC Enforcement Policy was first issued
as a formal policy statement on September 4, 1980. Since that time, the
Enforcement Policy has been revised on a number of occasions. On June
30, 1995; (60 FR 34381), the Enforcement Policy was completely revised
as a result of the recommendations of a high-level review team who
assessed the enforcement program and solicited input from stakeholders
and other government agencies (NUREG-1525, ``Assessment of the NRC
Enforcement Program.'') On May 13, 1998; (63 FR 26630) the Enforcement
Policy was completely republished based on a review of the experience
with the revised policy and consideration of public comment (NUREG-
1600, ``NRC Enforcement Policy Review; July 1995-July 1997''). Most
recently (February 9, 1999; 64 FR 6388), the Policy was modified by
revising the treatment of Severity Level IV violations at power
reactors to help reduce unnecessary regulatory burden. The NRC is
constantly refining and improving its policy and processes to ensure
that enforcement actions are appropriate and contribute to safety.
In developing this Policy revision, the NRC considered comments of
various internal and external stakeholders. Consideration was given to
written comments submitted in response to the May 13, 1998; 63 FR
26630, revision to the Enforcement Policy; Congressional concerns;
information provided during numerous meetings with representatives of
the industry and public interest groups; and several written
submittals.1 The main stakeholder involvement has been with
the Nuclear Energy Institute (NEI), various power reactor licensees,
the Union of Concerned Scientists (UCS), and Public Citizen.
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\1\ See, NEI letters to James Lieberman, dated December 14,
1998, and to William Travers, dated October 23, 1998, and UCS letter
to James Lieberman dated November 11, 1998. These documents are
available at the NRC's Public Document Room (see ADDRESSES section).
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The NRC recognizes that additional changes may be considered as a
result of ongoing efforts to make improvements to the inspection and
performance assessment processes for power reactors. In addition,
changes are anticipated in the materials areas that will conform to the
move toward risk-informed performance-based inspections in this area.
The more significant changes to the Enforcement Policy (in the
order that they appear in the Policy) are described below:
I. Introduction and Purpose
This section has been modified by adding a discussion of the
relationship between safety and compliance. This discussion captures
the essence of the Commission-approved discussion that was previously
included as Appendix A to this policy statement. Moving this discussion
from the back of the Policy to the front improves the logical flow of
information and helps ensure that it will not be overlooked.
III. Responsibilities
This section has been modified to reflect the August 9, 1999,
reorganization of the office of the Executive Director for Operations.
The Deputy Executive Director for Reactor Programs and the Deputy
Executive Director for Materials, Research and State Programs, replace
the Deputy Executive Director for Regulatory Effectiveness as the
principal enforcement officers of the NRC. The Deputy Executive
Director for Reactor Programs is responsible to the Executive Director
for Operations for NRC enforcement programs.
IV. Significance of Violations
This section has been renamed and significantly modified to reflect
the NRC's new approach on how it will assess the significance of
violations.
Because regulatory requirements have varying degrees of safety,
safeguards, or environmental significance, the NRC's Enforcement Policy
uses a graded approach in dealing with noncompliances both in terms of
assessing significance and developing enforcement sanctions. This
section provides that assessing the relative importance or significance
of the violation is the first step in the enforcement process. The NRC
is revising its approach for assessing significance that identifies
four specific issues to consider: (1) Actual safety consequences; (2)
potential safety consequences, including the consideration of risk
information; (3) potential for impacting the NRC's ability to perform
its regulatory function; and (4) any willful aspects of the violation.
This is a change from previous practice that assessed significance
by weighing (1) Actual consequences; (2) potential consequences; and
(3) the regulatory significance of a violation. Although not
specifically defined by the Policy, ``regulatory significance''
historically included issues such as, but not limited to, programmatic
breakdowns (i.e., aggregation of violations 2), repetitive
violations, willful violations and reporting violations. The NRC is
eliminating the use of this term in the context of assessing the
significance of violations. The NRC believes this is warranted given
the nature of stakeholder concerns, which included the term's lack of
sufficient definition, its subjective nature, and its lack of a clear
nexus to safety. There is also a concern that use of regulatory
significance (under the practice of aggregation) is a form of
assessment that should be performed outside the enforcement process.
Under the revised Policy, if the NRC has concerns about a licensee's
performance as a result of a large number of less significant
violations, or repetitive violations based on ineffective corrective
actions, the current and future assessment processes provide the
regulatory tools necessary to address these performance concerns.
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\2\ The previous policy stated that a group of Severity Level IV
violations could be evaluated in the aggregate and assigned a
single, increased severity level, thereby resulting in a Severity
Level III problem, if the violations had the same underlying cause
or programmatic deficiencies.
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Although the NRC believes it is appropriate to eliminate the term,
``regulatory significance'' from this policy statement, some of its
underlying concepts are appropriate to maintain. The NRC will continue
to consider violations that impact or have the potential to impact
NRC's ability to carry out its statutory mission. Examples of cases in
this category would include violations of Secs. 30.9, 50.9, etc.
(completeness and accuracy of information), Secs. 30.34(f), 50.54(a),
50.59, 76.68, etc. (need for NRC approval of changes), and Subpart M of
Part 20, Secs. 30.50, 50.72-73, etc. (reporting requirements). 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 in order to monitor compliance with safety
standards are based primarily on complete, accurate and timely
recordkeeping and reporting. The NRC will continue to consider willful
violations involving licensees and their employees, including the
ability to maintain a safety conscious work environment. Examples of
cases in this category would include violations of Secs. 30.10, 50.5,
etc. (deliberate misconduct), and willful violations of requirements
including Secs. 30.7, 50.7, etc. (discrimination), Secs. 30.9, 50.9,
etc. (completeness and accuracy of information), and reporting
requirements. Willful violations are, by definition, of particular
concern to the
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Commission because its regulatory program is based on licensees and
their contractors, employees, and agents acting with integrity and
communicating with candor.
This section also elaborates on the concept of potential
consequences as a consideration in the significance assessment process.
It emphasizes that the NRC will consider the realistic likelihood of
affecting safety (i.e., the existence of credible scenarios with
potentially significant consequences). It also states that risk
information will be used wherever possible and clarifies that use of
risk information may increase or decrease the severity level of a
violation.
This overall approach to assessing significance preserves the
ability to evaluate violations based on those concepts the NRC believes
important, while minimizing the controversy that surrounds the use of
the term ``regulatory significance.''
VI.B.2.d Exercise of Discretion
The guidance in this section has been rewritten to state that the
NRC may exercise discretion by either escalating or mitigating the
amount of a civil penalty after the normal assessment process to ensure
that the proposed civil penalty reflects all relevant circumstances of
the particular case. The phrases ``reflects the NRC's level of
concern'' and ``conveys the appropriate message to the licensee'' have
been eliminated. Like regulatory significance, these phrases have been
criticized as allowing the regulator to arbitrarily issue sanctions
without a sufficient nexus to safety. This new language is consistent
with the agency's other policy changes and its plain language
initiatives. Similar changes are made throughout the Policy.
VII.A.1 Civil Penalties
Paragraph (h) of this section has been modified to include the
correct schedule the NRC will use when it considers whether it should
exercise escalating enforcement discretion for violations associated
with departures from the FSAR. The previous schedule stated, ``after
two years from October 18, 1996.'' The correct schedule identifies
March 30, 2000, for risk-significant items as defined by the licensee's
maintenance rule program and March 30, 2001, for all other issues. This
change corrects an error in the policy and conforms to the schedule
established by the Commission in a staff requirements memorandum dated
June 30, 1998.
VII.B.1 Non-Cited Violations
This section has been renamed and consolidates the guidance on
dispositioning Severity Level IV violations as either Notices of
Violation or Non-Cited Violations. The definition of a Non-Cited
Violation (NCV) is simplified to state that it is a Severity Level IV
violation for which the NRC chooses to exercise discretion and refrain
from issuing a formal Notice of Violation. It makes it clear that this
discretion is not meant to eliminate either the NRC's emphasis on
compliance or the importance of maintaining safety. Section VII.B.1.a
includes the essence of the guidance on dispositioning power reactor
Severity Level IV violations that was previously included in Appendix
C. Sections VII.B.1.b-g are reserved for future applications. Section
VII.B.1.h includes guidance for dispositioning all other types of
licensees. This subsection captures the guidance that was previously
included under VII.B.1.
VII.B.3 Violations Involving Old Design Issues
Paragraph (a) of this section has been modified to include the
correct schedule the NRC will use when it considers whether it should
exercise mitigating enforcement discretion for violations associated
with departures from the FSAR. The previous schedule stated, ``within
two years after October 18, 1996.'' The correct schedule identifies
March 30, 2000, for risk-significant items as defined by the licensee's
maintenance rule program and March 30, 2001, for all other issues. Like
the schedule in Section VII.A.1.h, this Commission-approved schedule
inadvertently failed to be reflected in a revision to the policy
statement.
VII.C Notice of Enforcement Discretion for Power Reactors and
Gaseous Diffusion Plants
This section has been renamed to more clearly reflect that this
type of discretion applies to both power reactors and gaseous diffusion
plants.
Supplements--Violation Examples
Each of the eight supplements was modified by removing examples of
violations based on the concept of aggregating less significant
violations into one of higher significance and the use of repetitive
violations to increase the severity of a given violation, i.e., ``a
number of violations that are related (or, if isolated, that are
recurring violations) that collectively represent a potentially
significant lack of attention or carelessness toward licensed
responsibilities.''
Supplement I--Reactor Operations
Example B.4 is eliminated because it was unnecessary, given that it
is highly unlikely that Sec. 50.59 violations will rise to Severity
Level II and if operability of equipment is actually affected, then the
severity level of the system inoperability will be based on the actual
and potential consequences of that inoperability.
Example C.2. (b) is eliminated because basing severity level on any
necessary analyses is inconsistent with determining severity level
based on actual and potential consequences.
Example C.9 replaces previous examples C.10 and C.11 (which are no
longer consistent with recent revisions of 10 CFR 50.59). This example
provides that violations of 10 CFR 50.59 will be characterized at
Severity Level III only if the change, which would require Commission
approval prior to implementation, would not have been found acceptable
to the Commission.
Example C.10 replaces previous example C.13 and reflects that
Severity Level III characterization may be appropriate for violations
of 10 CFR 50.71(e) in those situations where the erroneous information
contained in the FSAR resulted in a change to the facility, implemented
without prior Commission approval, that would not be acceptable.
Example C.11 replaces previous example C.14. Given that unreviewed
safety questions and conflicts with technical specifications will not
necessarily be Severity Level III violations under the revised
enforcement guidance pertaining to 10 CFR 50.59, this example simply
reflects that the failure to make required reports associated with any
Severity Level III violation may be characterized at Severity Level
III.
Example D.5 replaces previous examples D.5 and D.6 (which are no
longer consistent with recent revisions of 10 CFR 50.59). This example
provides that Severity Level IV categorization is appropriate for
violations of 10 CFR 50.59 that do not involve circumstances in which a
change that required prior Commission approval would not be found
acceptable had the approval been sought. Any reference to programmatic
failures is unnecessary.
Example D.6 replaces previous examples D.7 and D.8 (which are no
longer consistent with recent revisions of 10 CFR 50.59). This example
provides that Severity Level IV characterization may be appropriate for
violations of 10 CFR 50.71(e) in those situations where the erroneous
information contained in the FSAR is not used to make an
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unacceptable change to the facility or procedures.
Paperwork Reduction Act
This final policy statement does not contain a new or amended
information collection requirement subject to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.). Existing requirements were
approved by the Office of Management and Budget, approval number 3150-
0136.
Public Protection Notification
If a means used to impose an information collection does not
display a currently valid OMB control number, the NRC may not conduct
or sponsor, and a person is not required to respond to, the information
collection.
Small Business Regulatory Enforcement Fairness Act
In accordance with the Small Business Regulatory Enforcement
Fairness Act of 1996, the NRC has determined that this action is not a
``major'' rule and has verified this determination with the Office of
Information and Regulatory Affairs, Office of Management and Budget.
Accordingly, the NRC Enforcement Policy is revised to read as
follows:
General Statement of Policy and Procedure for NRC Enforcement
Actions
Table of Contents
Preface
I. Introduction and Purpose
II. Statutory Authority and Procedural Framework
A. Statutory Authority
B. Procedural Framework
III. Responsibilities
IV. Significance of Violations
A. Assessing Significance
1. Actual Safety Consequences
2. Potential Safety Consequences
3. Impacting the Regulatory Process
4. Willful Violations
B. Assigning Severity Level
V. Predecisional Enforcement Conferences
VI. Enforcement Actions
A. Notice of Violation
B. Civil Penalty
1. Base Civil Penalty
2. Civil Penalty Assessment
a. Initial Escalated Action
b. Credit for Actions Related to Identification
c. Credit for Prompt and Comprehensive Corrective Action
d. Exercise of Discretion
C. Orders
D. Related Administrative Actions
VII. Exercise of Discretion
A. Escalation of Enforcement Sanctions
1. Civil Penalties
2. Orders
3. Daily Civil Penalties
B. Mitigation of Enforcement Sanctions
1. Non-Cited Violations (NCVs)
a. Power Reactor Licensees
b.-g. [Reserved]
h. All Other Licensees
2. Violations Identified During Extended Shutdowns or Work
Stoppages
3. Violations Involving Old Design Issues
4. Violations Identified Due to Previous Enforcement Action
5. Violations Involving Certain Discrimination Issues
6. Violations Involving Special Circumstances
C. Notice of Enforcement Discretion for Power Reactors and
Gaseous Diffusion Plants
VIII. Enforcement Actions Involving Individuals
IX. Inaccurate and Incomplete Information
X. Enforcement Action Against Non-Licensees
XI. Referrals to the Department of Justice
XII. Public Disclosure of Enforcement Actions
XIII. Reopening Closed Enforcement Actions
Supplements--Violation Examples
Interim Enforcement Policies
Interim Enforcement Policy for Generally Licensed Devices Containing
Byproduct Material (10 CFR 31.5)
Interim Enforcement Policy Regarding Enforcement Discretion for Nuclear
Power Plants During the Year 2000 Transition
Interim Enforcement Policy for Use During the NRC Power Reactor
Oversight Process Pilot Plant Study
Preface
The following policy statement describes the enforcement policy and
procedures that the U.S. Nuclear Regulatory Commission (NRC or
Commission) and its staff intends to follow in initiating and reviewing
enforcement actions in response to violations of NRC requirements. This
statement of general policy and procedure is published as NUREG-1600 to
foster its widespread dissemination. 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.
I. Introduction and Purpose
The Atomic Energy Act of 1954, as amended, establishes ``adequate
protection'' as the standard of safety on which NRC regulations are
based. In the context of NRC regulations, safety means avoiding undue
risk or, stated another way, providing reasonable assurance of adequate
protection of workers and the public in connection with the use of
source, byproduct and special nuclear materials.
While safety is the fundamental regulatory objective, compliance
with NRC requirements plays an important role in giving the NRC
confidence that safety is being maintained. NRC requirements, including
technical specifications, other license conditions, orders, and
regulations, have been designed to ensure adequate protection--which
corresponds to ``no undue risk to public health and safety''--through
acceptable design, construction, operation, maintenance, modification,
and quality assurance measures. In the context of risk-informed
regulation, compliance plays a very important role in ensuring that key
assumptions used in underlying risk and engineering analyses remain
valid.
While adequate protection is presumptively assured by compliance
with NRC requirements, circumstances may arise where new information
reveals that an unforeseen hazard exists or that there is a
substantially greater potential for a known hazard to occur. In such
situations, the NRC has the statutory authority to require licensee
action above and beyond existing regulations to maintain the level of
protection necessary to avoid undue risk to public health and safety.
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 occurs, the NRC must evaluate the
degree of risk posed by that noncompliance to determine if specific
immediate action is required. Where needed to ensure adequate
protection of public health and safety, the NRC may demand immediate
licensee action, up to and including a shutdown or cessation 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, issuing orders, or providing input to other
regulatory actions or assessments, such as increased oversight (e.g.,
increased inspection). 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.
The primary purpose of the NRC's Enforcement Policy is to support
the NRC's overall safety mission in protecting the public health and
safety and the environment. Consistent with that purpose, the policy
endeavors to:
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Deter noncompliance by emphasizing the importance of
compliance with NRC requirements, and
Encourage prompt identification and prompt, comprehensive
correction of violations of NRC requirements.
Therefore, licensees,1 contractors,2 and
their employees who do not achieve the high standard of compliance
which the NRC expects will be subject to enforcement sanctions. Each
enforcement action is dependent on the circumstances of the case.
However, in no case will licensees who cannot achieve and maintain
adequate levels of safety be permitted to continue to conduct licensed
activities.
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\1\ This policy primarily addresses the activities of NRC
licensees and applicants for NRC licenses. However, this policy
provides for taking enforcement action against non-licensees and
individuals in certain cases. These non-licensees include
contractors and subcontractors, holders of, or applicants for, NRC
approvals, e.g., certificates of compliance, early site permits, or
standard design certificates, and the employees of these non-
licensees. Specific guidance regarding enforcement action against
individuals and non-licensees is addressed in Sections VIII and X,
respectively.
\2\ The term ``contractor'' as used in this policy includes
vendors who supply products or services to be used in a NRC-licensed
facility or activity.
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II. Statutory Authority and Procedural Framework
A. Statutory Authority
The NRC's enforcement jurisdiction is drawn from the Atomic Energy
Act of 1954, as amended, and the Energy Reorganization Act (ERA) of
1974, as amended.
Section 161 of the Atomic Energy Act authorizes the NRC to conduct
inspections and investigations and to issue orders as may be necessary
or desirable to promote the common defense and security or to protect
health or to minimize danger to life or property. Section 186
authorizes the NRC to revoke licenses under certain circumstances
(e.g., for material false statements, in response to conditions that
would have warranted refusal of a license on an original application,
for a licensee's failure to build or operate a facility in accordance
with the terms of the permit or license, and for violation of an NRC
regulation). Section 234 authorizes the NRC to impose civil penalties
not to exceed $100,000 per violation per day for the violation of
certain specified licensing provisions of the Act, rules, orders, and
license terms implementing these provisions, and for violations for
which licenses can be revoked. In addition to the enumerated provisions
in section 234, sections 84 and 147 authorize the imposition of civil
penalties for violations of regulations implementing those provisions.
Section 232 authorizes the NRC to seek injunctive or other equitable
relief for violation of regulatory requirements.
Section 206 of the Energy Reorganization Act authorizes the NRC to
impose civil penalties for knowing and conscious failures to provide
certain safety information to the NRC.
Notwithstanding the $100,000 limit stated in the Atomic Energy Act,
the Commission may impose higher civil penalties as provided by the
Debt Collection Improvement Act of 1996. Under the Act, the Commission
is required to modify civil monetary penalties to reflect inflation.
The adjusted maximum civil penalty amount is reflected in 10 CFR 2.205
and this Policy Statement.
Chapter 18 of the Atomic Energy Act provides for varying levels of
criminal penalties (i.e., monetary fines and imprisonment) for willful
violations of the Act and regulations or orders issued under sections
65, 161(b), 161(i), or 161(o) of the Act. Section 223 provides that
criminal penalties may be imposed on certain individuals employed by
firms constructing or supplying basic components of any utilization
facility if the individual knowingly and willfully violates NRC
requirements such that a basic component could be significantly
impaired. Section 235 provides that criminal penalties may be imposed
on persons who interfere with inspectors. Section 236 provides that
criminal penalties may be imposed on persons who attempt to or cause
sabotage at a nuclear facility or to nuclear fuel. Alleged or suspected
criminal violations of the Atomic Energy Act are referred to the
Department of Justice for appropriate action.
B. Procedural Framework
Subpart B of 10 CFR Part 2 of NRC's regulations sets forth the
procedures the NRC uses in exercising its enforcement authority. 10 CFR
2.201 sets forth the procedures for issuing Notices of Violation.
The procedure to be used in assessing civil penalties is set forth
in 10 CFR 2.205. This regulation provides that the civil penalty
process is initiated by issuing a Notice of Violation and Proposed
Imposition of a Civil Penalty. The licensee or other person is provided
an opportunity to contest in writing the proposed imposition of a civil
penalty. After evaluation of the response, the civil penalty may be
mitigated, remitted, or imposed. An opportunity is provided for a
hearing if a civil penalty is imposed. If a civil penalty is not paid
following a hearing or if a hearing is not requested, the matter may be
referred to the U.S. Department of Justice to institute a civil action
in District Court.
The procedure for issuing an order to institute a proceeding 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
is set forth in 10 CFR 2.202. The licensee or any other person
adversely affected by the order may request a hearing. The NRC is
authorized to make orders immediately effective if required to protect
the public health, safety, or interest, or if the violation is willful.
Section 2.204 sets out the procedures for issuing a Demand for
Information (Demand) to a licensee or other person subject to the
Commission's jurisdiction for the purpose of determining whether an
order or other enforcement action should be issued. The Demand does not
provide hearing rights, as only information is being sought. A licensee
must answer a Demand. An unlicensed person may answer a Demand by
either providing the requested information or explaining why the Demand
should not have been issued.
III. Responsibilities
The Executive Director for Operations (EDO) and the principal
enforcement officers of the NRC, the Deputy Executive Director for
Reactor Programs (DEDR) and the Deputy Executive Director for
Materials, Research and State Programs (DEDMRS) have been delegated the
authority to approve or issue all escalated enforcement
actions.3 The DEDR is responsible to the EDO for NRC
enforcement programs. The Office of Enforcement (OE) exercises
oversight of and implements the NRC enforcement program. The Director,
OE, acts for the Deputy Executive Director in enforcement matters in
his absence or as delegated.
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\3\ The term ``escalated enforcement action'' as used in this
policy means a Notice of Violation or civil penalty for any Severity
Level I, II, or III violation (or problem) or any order based upon a
violation.
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Subject to the oversight and direction of OE, and with the approval
of the Deputy Executive Director, where necessary, the regional offices
normally issue Notices of Violation and proposed civil penalties.
However, subject to the same oversight as the regional offices, the
Office of Nuclear Reactor Regulation (NRR) and the Office of Nuclear
Material Safety and Safeguards (NMSS) may also issue Notices of
Violation and proposed civil penalties for certain activities.
Enforcement orders are normally issued by the Deputy Executive Director
or the Director, OE.
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However, orders may also be issued by the EDO, especially those
involving the more significant matters. The Directors of NRR and NMSS
have also been delegated authority to issue orders, but it is expected
that normal use of this authority by NRR and NMSS will be confined to
actions not associated with compliance issues. The Chief Financial
Officer has been delegated the authority to issue orders where
licensees violate Commission regulations by nonpayment of license and
inspection fees.
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, including the
decision to issue a Notice of Violation, 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 and the surrounding circumstances.
Unless Commission consultation or notification is required by this
policy, the NRC staff may depart, where warranted in the public's
interest, from this policy as provided in Section VII, ``Exercise of
Discretion.''
The Commission will be provided written notification for the
following situations:
(1) All enforcement actions involving civil penalties or orders;
(2) The first time that discretion is exercised for a plant that
meets the criteria of Section VII.B.2;
(3) (Where appropriate, based on the uniqueness or significance of
the issue) when discretion is exercised for violations that meet the
criteria of Section VII.B.6; and
(4) All Notices of Enforcement Discretion (NOEDs) issued involving
natural events, such as severe weather conditions.
The Commission will be consulted prior to taking action in the
following situations (unless the urgency of the situation dictates
immediate action):
(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 (cases involving
severe weather or other natural phenomena may be addressed by the staff
without prior Commission consultation in accordance with Section
VII.C);
(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 1A for that class of licensee;
(3) Any proposed enforcement action that involves a Severity Level
I violation;
(4) Any action 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 of OI concludes that
Commission consultation is warranted; and
(6) Any proposed enforcement action on which the Commission asks to
be consulted.
IV. Significance of Violations
Regulatory requirements 4 have varying degrees of
safety, safeguards, or environmental significance. Therefore, the
relative importance or significance of each violation is assessed as
the first step in the enforcement process. Following this assessment, a
commensurate severity level may be assigned to help determine and
develop the appropriate enforcement sanction.
---------------------------------------------------------------------------
\4\ The term ``requirement'' as used in this policy means a
legally binding requirement such as a statute, regulation, license
condition, technical specification, or order.
---------------------------------------------------------------------------
A. Assessing Significance
In assessing the significance of a noncompliance, the NRC considers
four specific issues: (1) actual safety consequences; (2) potential
safety consequences, including the consideration of risk information;
(3) potential for impacting the NRC's ability to perform its regulatory
function; and (4) any willful aspects of the violation.
1. Actual Safety Consequences
In evaluating actual safety consequences, the NRC considers issues
such as actual onsite or offsite releases of radiation, onsite or
offsite radiation exposures, accidental criticalities, core damage,
loss of significant safety barriers, loss of control of radioactive
material or radiological emergencies.
2. Potential Safety Consequences
In evaluating potential safety consequences, the NRC considers the
realistic likelihood of affecting safety, i.e., the existence of
credible scenarios with potentially significant actual consequences.
The NRC will use risk information wherever possible in assessing
significance and assigning severity levels. A higher severity may be
warranted for violations that have greater risk significance and a
lower severity level may be appropriate for issues that have low risk
significance. Duration is an appropriate consideration in assessing the
significance of violations.
3. Impacting the Regulatory Process
The NRC considers the safety implications of noncompliances which
may impact the NRC's ability to carry out its statutory mission.
Noncompliances may be significant because they may challenge the
regulatory envelope upon which certain activities were licensed. These
types of violations include failures such as: failures to provide
complete and accurate information, failures to receive prior NRC
approval for changes in licensed activities, failures to notify NRC of
changes in licensed activities, failure to perform 10 CFR 50.59
analysis, reporting failures, 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 in order
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 safety significant. 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 reasonableness of the failure given
their position and training, and whether the failure invalidates the
licensing basis. Factors to consider for failures to provide complete
and accurate information are addressed in Section IX of this policy.
Unless otherwise categorized in the Supplements to this policy
statement, the severity level of a violation involving the failure to
make a required report to the NRC will be based upon 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
surrounding the matter. A licensee will not normally be cited 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. A licensee
will, on the other hand, normally be cited for a failure to
[[Page 61148]]
report a condition or event if the licensee knew of the information to
be reported, but did not recognize that it was required to make a
report.
4. Willful Violations
Willful violations are by definition of particular concern to the
Commission because its regulatory program is based on licensees and
their contractors, employees, and agents acting with integrity and
communicating with candor. Willful violations cannot be tolerated by
either the Commission or a licensee. Therefore, a violation may be
considered more significant than the underlying noncompliance if it
includes indications of willfulness. The term ``willfulness'' as used
in this policy embraces a spectrum of violations ranging from
deliberate intent to violate or falsify to and including careless
disregard for requirements. Willfulness does not include acts which do
not rise to the level of careless disregard, e.g., negligence,
inadvertent clerical errors in a document submitted to the NRC. In
determining the significance of a violation involving willfulness,
consideration will be given to such factors as the position and
responsibilities of the person involved in the violation (e.g.,
licensee official 5 or non-supervisory 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 arriving at the significance
assessment will be dependent 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 it demonstrates the
seriousness of the violation thereby creating a deterrent effect within
the licensee's organization.
---------------------------------------------------------------------------
\5\ The term ``licensee official'' as used in this policy
statement 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, severity level
categorization for willful acts involving individuals who can be
considered licensee officials will consider several factors,
including the position of the individual relative to the licensee's
organizational structure and the individual's responsibilities
relative to the oversight of licensed activities and to the use of
licensed material.
---------------------------------------------------------------------------
B. Assigning Severity Level
For purposes of formal enforcement action, violations are normally
categorized in terms of four levels of severity to show their relative
importance or significance within each of the following eight activity
areas:
I. Reactor Operations;
II. Facility Construction;
III. Safeguards;
IV. Health Physics;
V. Transportation;
VI. Fuel Cycle and Materials Operations;
VII. Miscellaneous Matters; and
VIII. Emergency Preparedness.
Licensed activities will be placed in the activity area most
suitable in light of the particular violation involved including
activities not directly covered by one of the above listed areas, e.g.,
export license activities. Within each activity area, Severity Level I
has been assigned to violations that are the most significant and
Severity Level IV violations are the least significant. Severity Level
I and II violations are of very significant regulatory concern
6. In general, violations that are included in these
severity categories involve actual or high potential consequences on
public health and safety. Severity Level III violations are cause for
significant regulatory concern. Severity Level IV violations are less
serious but are of more than minor concern. Violations at Severity
Level IV involve noncompliance with NRC requirements that are not
considered significant based on risk. This should not be misunderstood
to imply that Severity Level IV issues have no risk significance.
---------------------------------------------------------------------------
\6\ Regulatory concern pertains to primary NRC regulatory
responsibilities, i.e., safety, safeguards, and the environment.
---------------------------------------------------------------------------
The Commission recognizes that there are other violations of minor
safety or environmental concern which are below the level of
significance of Severity Level IV violations. These minor violations
are not the subject of formal enforcement action and are not usually
described in inspection reports. To the extent such violations are
described, they will be noted as violations of minor significance that
are not subject to formal enforcement action.
Comparisons of significance between activity areas are
inappropriate. For example, the immediacy of any hazard to the public
associated with Severity Level I violations in Reactor Operations is
not directly comparable to that associated with Severity Level I
violations in Facility Construction.
Supplements I through VIII provide examples and serve as guidance
in determining the appropriate severity level for violations in each of
the eight activity areas. However, the examples are neither exhaustive
nor controlling. In addition, these examples do not create new
requirements. Each is designed to illustrate the significance that the
NRC places on a particular type of violation of NRC requirements. Each
of the examples in the supplements is predicated on a violation of a
regulatory requirement.
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 best suited to the significance of the
particular violation.
V. Predecisional Enforcement Conferences
Whenever the NRC has learned of the existence of a potential
violation for which escalated enforcement action appears to be
warranted, or recurring nonconformance on the part of a contractor, the
NRC may provide an opportunity for a predecisional enforcement
conference with the licensee, contractor, or other person before taking
enforcement action. The purpose of the conference is to obtain
information that will assist the NRC in determining the appropriate
enforcement action, such as: (1) A common understanding of facts, root
causes and missed opportunities associated with the apparent
violations; (2) a common understanding of corrective actions taken or
planned; and (3) a common understanding of the significance of issues
and the need for lasting comprehensive corrective action.
If the NRC concludes that it has sufficient information to make an
informed enforcement decision, a conference will not normally be held.
However, an opportunity for a conference will normally be provided
before issuing an order based on a violation of the rule on Deliberate
Misconduct or a civil penalty to an unlicensed person. If a conference
is not held, the licensee may be requested to provide a written
response to an inspection report, if issued, as to the licensee's views
on the apparent violations and their root causes and a description of
planned or implemented corrective actions. However, if the NRC has
sufficient information to conclude that a civil penalty is not
warranted, it may proceed to issue an enforcement action without first
obtaining the licensee's response to the inspection report.
During the predecisional enforcement conference, the licensee,
contractor, or other persons will be given an
[[Page 61149]]
opportunity to provide information consistent with the purpose of the
conference, including an explanation to the NRC of the immediate
corrective actions (if any) that were taken following identification of
the potential violation or nonconformance and the long-term
comprehensive actions that were taken or will be taken to prevent
recurrence. Licensees, contractors, or other persons will be told when
a meeting is a predecisional enforcement conference.
A predecisional enforcement conference is a meeting between the NRC
and the licensee. Conferences are normally held in the regional offices
and are normally open to public observation. Conferences will not
normally be open to the public if the enforcement action being
contemplated:
(1) Would be taken against an individual, or if the action, though
not taken against an individual, turns on whether an individual has
committed wrongdoing;
(2) Involves significant personnel failures where the NRC has
requested that the individual(s) involved be present at the conference;
(3) Is based on the findings of an NRC Office of Investigations
report that has not been publicly disclosed; or
(4) Involves safeguards information, Privacy Act information, or
information which could be considered proprietary;
In addition, conferences will not normally be open to the public
if:
(5) The conference involves medical misadministrations or
overexposures and the conference cannot be conducted without disclosing
the exposed individual's name; or
(6) The conference will be conducted by telephone or the conference
will be conducted at a relatively small licensee's facility.
Notwithstanding meeting any of these criteria, a conference may
still be open if the conference involves issues related to an ongoing
adjudicatory proceeding with one or more interveners or where the
evidentiary basis for the conference is a matter of public record, such
as an adjudicatory decision by the Department of Labor. In addition,
notwithstanding the above normal criteria for opening or closing
conferences, with the approval of the Executive Director for
Operations, conferences may either be open or closed to the public
after balancing the benefit of the public's observation against the
potential impact on the agency's decision-making process in a
particular case.
The NRC will notify the licensee that the conference will be open
to public observation. Consistent with the agency's policy on open
meetings (included on the NRC's Public Meeting Web site), the NRC
intends to announce open conferences normally at least 10 calendar days
in advance of conferences. Conferences will be announced on the
Internet at the NRC Office of Enforcement's homepage (www.nrc.gov/OE)
and on the Public Meeting Web site (www.nrc.gov/NRC/PUBLIC/meet.html).
Individuals who do not have Internet access may get assistance on
scheduled conferences by contacting the NRC staff at the Public
Document Room, by calling toll-free 1-800-397-4209. In addition, the
NRC will normally issue a press release and notify appropriate State
liaison officers that a predecisional enforcement conference has been
scheduled and that it is open to public observation.
The public attending open conferences may observe but may not
participate in the conference. It is noted that the purpose of
conducting open conferences is not to maximize public attendance, but
rather to provide the public with opportunities to be informed of NRC
activities consistent with the NRC's ability to exercise its regulatory
and safety responsibilities. Therefore, members of the public will be
allowed access to the NRC regional offices to attend open enforcement
conferences in accordance with the ``Standard Operating Procedures For
Providing Security Support For NRC Hearings and Meetings,'' published
November 1, 1991 (56 FR 56251). These procedures provide that visitors
may be subject to personnel screening, that signs, banners, posters,
etc., not larger than 18'' be permitted, and that disruptive persons
may be removed. The open conference will be terminated if disruption
interferes with a successful conference. NRC's Predecisional
Enforcement Conferences (whether open or closed) normally will be held
at the NRC's regional offices or in NRC Headquarters Offices and not in
the vicinity of the licensee's facility.
For a case in which an NRC Office of Investigations (OI) report
finds that discrimination as defined under 10 CFR 50.7 (or similar
provisions in Parts 30, 40, 60, 70, or 72) has occurred, the OI report
may be made public, subject to withholding certain information (i.e.,
after appropriate redaction), in which case the associated
predecisional enforcement conference will normally be open to public
observation. In a conference where a particular individual is being
considered potentially responsible for the discrimination, the
conference will remain closed. In either case (i.e., whether the
conference is open or closed), the employee or former employee who was
the subject of the alleged discrimination (hereafter referred to as
``complainant'') will normally be provided an opportunity to
participate in the predecisional enforcement conference with the
licensee/employer. This participation will normally be in the form of a
complainant statement and comment on the licensee's presentation,
followed in turn by an opportunity for the licensee to respond to the
complainant's presentation. In cases where the complainant is unable to
attend in person, arrangements will be made for the complainant's
participation by telephone or an opportunity given for the complainant
to submit a written response to the licensee's presentation. If the
licensee chooses to forego an enforcement conference and, instead,
responds to the NRC's findings in writing, the complainant will be
provided the opportunity to submit written comments on the licensee's
response. For cases involving potential discrimination by a contractor,
any associated predecisional enforcement conference with the contractor
would be handled similarly. These arrangements for complainant
participation in the predecisional enforcement conference are not to be
conducted or viewed in any respect as an adjudicatory hearing. The
purpose of the complainant's participation is to provide information to
the NRC to assist it in its enforcement deliberations.
A predecisional enforcement conference may not need to be held in
cases where there is a full adjudicatory record before the Department
of Labor. If a conference is held in such cases, generally the
conference will focus on the licensee's corrective action. As with
discrimination cases based on OI investigations, the complainant may be
allowed to participate.
Members of the public attending open conferences will be reminded
that (1) The apparent violations discussed at predecisional enforcement
conferences are subject to further review and may be subject to change
prior to any resulting enforcement action and (2) the statements of
views or expressions of opinion made by NRC employees at predecisional
enforcement conferences, or the lack thereof, are not intended to
represent final determinations or beliefs.
When needed to protect the public health and safety or common
defense and security, escalated enforcement action, such as the
issuance of an immediately effective order, will be taken before the
conference. In these cases, a conference may be held after the
escalated enforcement action is taken.
[[Page 61150]]
VI. Enforcement Actions
This section describes the enforcement sanctions available to the
NRC and specifies the conditions under which each may be used. The
basic enforcement sanctions are Notices of Violation, civil penalties,
and orders of various types. As discussed further in Section VI.D,
related administrative actions such as Notices of Nonconformance,
Notices of Deviation, Confirmatory Action Letters, Letters of
Reprimand, and Demands for Information are used to supplement the
enforcement program. In selecting the enforcement sanctions or
administrative actions, the NRC will consider enforcement actions taken
by other Federal or State regulatory bodies having concurrent
jurisdiction, such as in transportation matters.
Usually, whenever a violation of NRC requirements of more than a
minor concern is identified, enforcement action is taken. The nature
and extent of the enforcement action is intended to reflect the
seriousness of the violation involved.
However, circumstances regarding the violation findings may warrant
discretion being exercised such that the NRC refrains from issuing a
Notice of Violation or other enforcement action. (See Section VII.B,
``Mitigation of Enforcement Sanctions.'')
A. Notice of Violation
A Notice of Violation is a written notice setting forth one or more
violations of a legally binding requirement. The Notice of Violation
normally requires the recipient to provide a written statement
describing (1) the reasons for the violation or, if contested, the
basis for disputing the violation; (2) corrective steps that have been
taken and the results achieved; (3) corrective steps that will be taken
to prevent recurrence; and (4) the date when full compliance will be
achieved. The NRC may waive all or portions of a written response to
the extent relevant information has already been provided to the NRC in
writing or documented in an NRC inspection report. The NRC may require
responses to Notices of Violation to be under oath. Normally, responses
under oath will be required only in connection with Severity Level I,
II, or III violations or orders.
The NRC uses the Notice of Violation as the usual method for
formalizing the existence of a violation. Issuance of a Notice of
Violation is normally the only enforcement action taken, except in
cases where the criteria for issuance of civil penalties and orders, as
set forth in Sections VI.B and VI.C, respectively, are met.
B. Civil Penalty
A civil penalty is a monetary penalty that may be imposed for
violation of (1) certain specified licensing provisions of the Atomic
Energy Act or supplementary NRC rules or orders; (2) any requirement
for which a license may be revoked; or (3) reporting requirements under
section 206 of the Energy Reorganization Act. Civil penalties are
designed to deter future violations both by the involved licensee as
well as by other licensees conducting similar activities and to
emphasize the need for licensees to identify violations and take prompt
comprehensive corrective action.
Civil penalties are considered for Severity Level III violations.
In addition, civil penalties will normally be assessed for Severity
Level I and II violations and knowing and conscious violations of the
reporting requirements of section 206 of the Energy Reorganization Act.
Civil penalties are used to encourage prompt identification and
prompt and comprehensive correction of violations, to emphasize
compliance in a manner that deters future violations, and to serve to
focus licensees' attention on significant violations.
Although management involvement, direct or indirect, in a violation
may lead to an increase in the civil penalty, the lack of management
involvement may not be used to mitigate a civil penalty. Allowing
mitigation in the latter case could encourage the lack of management
involvement in licensed activities and a decrease in protection of the
public health and safety.
1. Base Civil Penalty
The NRC imposes different levels of penalties for different
severity level violations and different classes of licensees,
contractors, and other persons. Tables 1A and 1B show the base civil
penalties for various reactor, fuel cycle, and materials programs.
(Civil penalties issued to individuals are determined on a case-by-case
basis.) The structure of these tables generally takes into account the
gravity of the violation as a primary consideration and the ability to
pay as a secondary consideration. Generally, operations involving
greater nuclear material inventories and greater potential consequences
to the public and licensee employees receive higher civil penalties.
Regarding the secondary factor of 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 puts a
licensee out of business (orders, rather than civil penalties, are used
when the intent is to suspend or terminate licensed activities) or
adversely affects a licensee's ability to safely conduct licensed
activities. The deterrent effect of civil penalties is best served when
the amounts of the penalties take into account a licensee's ability to
pay. In determining the amount of civil penalties for licensees for
whom the tables do not reflect the ability to pay or the gravity of the
violation, the NRC will consider as necessary an increase or decrease
on a case-by-case basis. Normally, if a licensee can demonstrate
financial hardship, the NRC will consider payments over time, including
interest, rather than reducing the amount of the civil penalty.
However, where a licensee claims financial hardship, the licensee will
normally be required to address why it has sufficient resources to
safely conduct licensed activities and pay license and inspection fees.
Table 1A.--Base Civil Penalties
------------------------------------------------------------------------
------------------------------------------------------------------------
a. Power reactors and gaseous diffusion plants.............. $110,000
b. Fuel fabricators authorized to possess Category I or II 55,000
quantities of SNM..........................................
c. Fuel fabricators, industrial processors,\1\ and 27,500
independent spent fuel and monitored retrievable storage
installations..............................................
d. Test reactors, mills and uranium conversion facilities, 11,000
contractors, waste disposal licensees, industrial
radiographers, and other large material users..............
e. Research reactors, academic, medical, or other small 5,500
material users\2\..........................................
------------------------------------------------------------------------
\1\ Large firms engaged in manufacturing or distribution of byproduct,
source, or special nuclear material.
\2\ This applies to nonprofit institutions not otherwise categorized in
this table, mobile nuclear services, nuclear pharmacies, and physician
offices.
Table 1B.--Base Civil Penalties
------------------------------------------------------------------------
Base civil
penalty
amount
Severity level (Percent of
amount
listed in
Table 1A)
------------------------------------------------------------------------
I.......................................................... 100
II......................................................... 80
III........................................................ 50
------------------------------------------------------------------------
2. Civil Penalty Assessment
In an effort to (1) emphasize the importance of adherence to
requirements and (2) reinforce prompt
[[Page 61151]]
self-identification of problems and root causes and prompt and
comprehensive correction of violations, the NRC reviews each proposed
civil penalty on its own merits and, after considering all relevant
circumstances, may adjust the base civil penalties shown in Table 1A
and 1B for Severity Level I, II, and III violations as described below.
The civil penalty assessment process considers four decisional
points: (a) Whether the licensee has had any previous escalated
enforcement action (regardless of the activity area) during the past 2
years or past 2 inspections, whichever is longer; (b) whether the
licensee should be given credit for actions related to identification;
(c) whether the licensee's corrective actions are prompt and
comprehensive; and (d) whether, in view of all the circumstances, the
matter in question requires the exercise of discretion. Although each
of these decisional 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%. The flow chart
presented below is a graphic representation of the civil penalty
assessment process.
BILLING CODE 7590-01-P
[GRAPHIC] [TIFF OMITTED] TN09NO99.003
BILLING CODE 7590-01-C
a. Initial escalated action. When the NRC determines that a non-
willful Severity Level 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 2 inspections, whichever 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 VI.B.2.c, below). Using
2 years as the basis for assessment is expected to cover most
situations, but considering a slightly longer or shorter period might
be warranted based on the circumstances of a particular case. The
starting point of this period should be considered the date when the
licensee was put on notice of the need to take corrective action. For a
licensee-identified violation or an event, this would be when the
licensee is aware that a problem or violation exists requiring
corrective action. For an NRC-identified violation, the starting point
would be when the NRC puts the licensee on notice, which could be
during the inspection, at the inspection exit meeting, or as part of
post-inspection communication.
If the corrective action is judged to be prompt and comprehensive,
a Notice of Violation normally should be issued with no associated
civil penalty. If the corrective action is judged to be less than
prompt and comprehensive, the Notice of Violation normally should be
issued with a base civil penalty.
b. Credit for Actions Related to Identification. (1) If a Severity
Level I or II violation or a willful Severity Level III violation has
occurred--or if, during the past 2 years or 2 inspections, whichever is
longer, the licensee has been issued at least one other escalated
action--the civil penalty assessment should normally consider the
factor of identification in addition to corrective action (see the
discussion under Section VI.B.2.c, below). As to identification, the
NRC should consider whether the licensee should be given credit for
actions related to identification.
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:
(i) Whether the problem requiring corrective action was NRC-
identified, licensee-identified, or revealed through an event;
7
---------------------------------------------------------------------------
\7\ An ``event,'' as used here, means (1) an event 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, the failure to have a system 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 discovered, through quarterly dosimetry readings, that
employees have been inadequately monitored for radiation, the issue
would normally be considered licensee-identified; however, if the
same dosimetry readings disclosed an overexposure, the issue would
be considered an event.
---------------------------------------------------------------------------
(ii) Whether prior opportunities existed to identify the problem
requiring corrective action, and if so, the age and number of those
opportunities;
(iii) 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;
(iv) 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;
(v) 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;
[[Page 61152]]
(vi) For NRC-identified issues, whether the licensee should have
identified the issue (and taken action) earlier; and
(vii) For cases in which the NRC identifies 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.
(2) 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:
(i) Licensee-Identified. When a problem requiring corrective action
is licensee-identified (i.e., identified before the problem has
resulted 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.
(ii) Identified Through an Event. When a problem requiring
corrective action is identified through an event, the decision on
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 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. As a
second instance, 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 ferreting out the
root cause and associated violations, or simply because no prior
opportunities (e.g., procedural cautions, post-maintenance testing,
quality control failures, readily observable parameter trends, or
repeated or locked-in annunciator warnings) existed to identify the
problem.
(iii) NRC-Identified. When a problem requiring corrective action is
NRC-identified, the decision on 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 might include a similar previous violation, NRC or
industry notices, internal audits, or readily observable trends.
If the NRC identifies the violation but concludes that, under the
circumstances, the licensee's actions related to Identification were
not unreasonable, the matter would be treated as licensee-identified
for purposes of assessing the civil penalty. In such cases, the
question of Identification credit shifts to whether the licensee should
be penalized for NRC's identification of the problem.
(iv) Mixed Identification. For ``mixed'' identification situations
(i.e., where multiple violations exist, some NRC-identified, some
licensee-identified, 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 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 NRC's path of
analysis had been dismissed or was being pursued in parallel by the
licensee.
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 taken the necessary
comprehensive action. Where this is true, the decision on whether to
give 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.
(v) 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 quality
assurance (QA) activities; (2) through 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. It 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 take action to identify or prevent similar problems at
the facility subject to the enforcement action at issue. In assessing
this factor, consideration will be given to, 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. Missed
opportunities is normally not applied where the licensee appropriately
reviewed the opportunity for application to its activities and
reasonable action was either taken or planned to be taken within a
reasonable time.
In some situations the missed opportunity is a violation in itself.
In these cases, unless the missed opportunity is a Severity Level III
violation in itself, the missed opportunity violation may be grouped
with the other violations into a single Severity Level III ``problem.''
However, if the missed opportunity is the only violation, then it
should not normally be counted twice (i.e., both as the violation and
as a missed opportunity--``double counting'') unless the number of
opportunities missed was particularly significant.
The timing of the missed opportunity should also be considered.
While a rigid time-frame is unnecessary, a 2-year period should
generally be considered for consistency in implementation, as the
period reflecting relatively current performance.
(3) 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, based on
[[Page 61153]]
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 a Notice of Violation with either a base civil penalty or a
base civil penalty escalated by 100%, depending on the quality of
Corrective Action, because the licensee's performance is clearly not
acceptable.
c. Credit for Prompt and Comprehensive Corrective Action. 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 and compliance with the license,
regulation(s), or other requirement(s); and (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 issuing at least a base civil penalty.
In assessing this factor, consideration will be given to 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 to the
specific violation or broadly to the general area of concern). Even in
cases 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.
Normally, the judgment of the adequacy of corrective actions will
hinge on whether the NRC had to take action to focus the licensee's
evaluative and corrective process in order to obtain comprehensive
corrective action. This will normally be judged 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 get 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
good 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.
Corrective action for violations involving discrimination should
normally only be considered comprehensive if the licensee takes prompt,
comprehensive corrective action that (1) addresses the broader
environment for raising safety concerns in the workplace, and (2)
provides a remedy for the particular discrimination at issue.
In response to violations of 10 CFR 50.59, corrective action should
normally be considered prompt and comprehensive only if the licensee
(i) Makes a prompt decision on operability; and either
(ii) Makes a prompt evaluation under 10 CFR 50.59 if the licensee
intends to maintain the facility or procedure in the as found
condition; or
(iii) Promptly initiates corrective action consistent with
Criterion XVI of 10 CFR 50, Appendix B, if it intends to restore the
facility or procedure to the FSAR description.
d. Exercise of Discretion. As provided in Section VII, ``Exercise
of Discretion,'' 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 $110,000 per day.
C. 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 may
also be issued in lieu of, or in addition to, civil penalties, as
appropriate for Severity Level I, II, or III violations. Orders may be
issued as follows:
1. License Modification orders are issued when some change in
licensee equipment, procedures, personnel, or management controls is
necessary.
2. Suspension Orders may be used:
(a) To remove a threat to the public health and safety, common
defense and security, or the environment;
(b) To stop facility construction when,
(i) Further work could preclude or significantly hinder the
identification or correction of an improperly constructed safety-
related system or component; or
(ii) The licensee's quality assurance program implementation is not
adequate to provide confidence that construction activities are being
properly carried out;
(c) When the licensee has not responded adequately to other
enforcement action;
(d) When the licensee interferes with the conduct of an inspection
or investigation; or
(e) For any reason not mentioned above for which license revocation
is legally authorized.
Suspensions may apply to all or part of the licensed activity.
Ordinarily, a licensed activity is not suspended (nor is a suspension
prolonged) for failure to comply with requirements where such failure
is not willful and adequate corrective action has been taken.
3. Revocation Orders may be used:
(a) When a licensee is unable or unwilling to comply with NRC
requirements;
(b) When a licensee refuses to correct a violation;
(c) When licensee does not respond to a Notice of Violation where a
response was required;
(d) When a licensee refuses to pay an applicable fee under the
Commission's regulations; or
(e) For any other reason for which revocation is authorized under
section 186 of the Atomic Energy Act (e.g., any condition which would
warrant refusal of a license on an original application).
4. Cease and Desist Orders may be used to stop an unauthorized
activity that has continued after notification by the NRC that the
activity is unauthorized.
5. Orders to non-licensees, including contractors and
subcontractors, holders of NRC approvals, e.g., certificates of
compliance, early site permits, standard design certificates, or
applicants for any of them, and to employees of any of the foregoing,
are used when the NRC has identified deliberate misconduct that may
cause a licensee to be in violation of an NRC requirement or where
incomplete or inaccurate information is
[[Page 61154]]
deliberately submitted or where the NRC loses its reasonable assurance
that the licensee will meet NRC requirements with that person involved
in licensed activities.
Unless a separate response is warranted pursuant to 10 CFR 2.201, a
Notice of Violation need not be issued where an order is based on
violations described in the order. The violations described in an order
need not be categorized by severity level.
Orders are made effective immediately, without prior opportunity
for hearing, whenever it is determined that the public health,
interest, or safety so requires, or when the order is responding to a
violation involving willfulness. Otherwise, a prior opportunity for a
hearing on the order is afforded. For cases in which the NRC believes a
basis could reasonably exist for not taking the action as proposed, the
licensee will ordinarily be afforded an opportunity to show why the
order should not be issued in the proposed manner by way of a Demand
for Information. (See 10 CFR 2.204)
D. Related Administrative Actions
In addition to the formal enforcement actions, Notices of
Violation, civil penalties, and orders, the NRC also uses
administrative actions, such as Notices of Deviation, Notices of
Nonconformance, Confirmatory Action Letters, Letters of Reprimand, and
Demands for Information to supplement its enforcement program. The NRC
expects licensees and contractors to adhere to any obligations and
commitments resulting from these actions and will not hesitate to issue
appropriate orders to ensure that these obligations and commitments are
met.
1. Notices of Deviation are written notices describing a licensee's
failure to satisfy a commitment where the commitment involved has not
been made a legally binding requirement. A Notice of Deviation requests
a licensee to provide a written explanation or statement describing
corrective steps taken (or planned), the results achieved, and the date
when corrective action will be completed.
2. Notices of Nonconformance are written notices describing
contractors' failures to meet commitments which have not been made
legally binding requirements by NRC. An example is a commitment made in
a procurement contract with a licensee as required by 10 CFR Part 50,
Appendix B. Notices of Nonconformances request non-licensees to 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.
3. Confirmatory Action Letters are letters confirming a licensee's
or contractor's agreement to take certain actions to remove significant
concerns about health and safety, safeguards, or the environment.
4. Letters of Reprimand are letters addressed to individuals
subject to Commission jurisdiction identifying a significant deficiency
in their performance of licensed activities.
5. Demands for Information are demands for information from
licensees or other persons for the purpose of enabling the NRC to
determine whether an order or other enforcement action should be
issued.
VII. Exercise of Discretion
Notwithstanding the normal guidance contained in this policy, as
provided in Section III, ``Responsibilities,'' the NRC may choose to
exercise discretion and either escalate or mitigate enforcement
sanctions within the Commission's statutory authority to ensure that
the resulting enforcement action takes into consideration all of the
relevant circumstances of the particular case.
A. Escalation of Enforcement Sanctions
The NRC considers violations categorized at Severity Level I, II,
or III to be of significant regulatory concern. If the application of
the normal guidance in this policy does not result in an appropriate
sanction, with the approval of the Deputy Executive Director and
consultation with the EDO and Commission, as warranted, the NRC may
apply its full enforcement authority where the action is warranted. NRC
action may include (1) escalating civil penalties; (2) issuing
appropriate orders; and (3) assessing civil penalties for continuing
violations on a per day basis, up to the statutory limit of $110,000
per violation, per day.
1. Civil Penalties
Notwithstanding the outcome of the normal civil penalty assessment
process addressed in Section VI.B, the NRC may exercise discretion by
either proposing a civil penalty where application of the factors would
otherwise result in zero penalty or by escalating the amount of the
resulting civil penalty (i.e., base or twice the base civil penalty) to
ensure that the proposed civil penalty reflects the significance of the
circumstances. The Commission will be notified if the deviation in the
amount of the civil penalty proposed under this discretion from the
amount of the civil penalty assessed under the normal process is more
than two times the base civil penalty shown in Tables 1A and 1B.
Examples when this discretion should be considered include, but are not
limited to the following:
(a) Problems categorized at Severity Level I or II;
(b) Overexposures, or releases of radiological material in excess
of NRC requirements;
(c) Situations involving particularly poor licensee performance, or
involving willfulness;
(d) Situations when the licensee's previous enforcement history has
been particularly poor, or when the current violation is directly
repetitive of an earlier violation;
(e) Situations when the violation results in a substantial increase
in risk, including cases in which the duration of the violation has
contributed to the substantial increase;
(f) Situations when the licensee made a conscious decision to be in
noncompliance in order to obtain an economic benefit;
(g) Cases involving the loss of a source. In addition, unless the
licensee self-identifies and reports the loss to the NRC, these cases
should normally result in a civil penalty in an amount at least in the
order of the cost of an authorized disposal of the material or of the
transfer of the material to an authorized recipient; or
(h) Severity Level II or III violations associated with departures
from the Final Safety Analysis Report identified after March 30, 2000,
for risk-significant items as defined by the licensee's maintenance
rule program and March 30, 2001, for all other issues. Such a violation
or problem would consider the number and nature of the violations, the
severity of the violations, whether the violations were continuing, and
who identified the violations (and if the licensee identified the
violation, whether exercise of Section VII.B.3 enforcement discretion
is warranted.)
2. Orders
The NRC may, where necessary or desirable, issues orders in
conjunction with or in lieu of civil penalties to achieve or formalize
corrective actions and to deter further recurrence of serious
violations.
3. Daily Civil Penalties
To recognize the added significance for those cases where a very
strong message is warranted for a significant violation that continues
for more than one day, the NRC may exercise discretion and assess a
separate violation and attendant civil penalty up to the statutory
limit of $110,000 for each day the violation continues. The
[[Page 61155]]
NRC may exercise this discretion if a licensee was aware or clearly
should have been aware of a violation, or if the licensee had an
opportunity to identify and correct the violation but failed to do so.
B. Mitigation of Enforcement Sanctions
The NRC may exercise discretion and refrain from issuing a civil
penalty and/or a Notice of Violation after considering the general
principles of this statement of policy and the surrounding
circumstances. The approval of the Director, Office of Enforcement,
with consultation with the Deputy Executive Director as warranted, is
required for exercising discretion of the type described in Sections
VII.B.1.a and VII.B.1.h where a willful violation is involved, and of
the types described in Sections VII.B.2 through VII.B.6. The
circumstances under which mitigation discretion should be considered
include, but are not limited to the following:
1. Non-Cited Violations (NCVs)
A Non-Cited Violation (NCV) is defined as a Severity Level IV
violation for which the staff chooses to exercise discretion in
accordance with the Enforcement Policy and refrain from issuing a
Notice of Violation pursuant to 10 CFR 2.201.
Severity Level IV violations are defined in the Enforcement Policy
as violations of more than minor concern. Violations at Severity Level
IV involve noncompliance with NRC requirements that are not considered
significant based on risk. This should not be misunderstood to imply
that Severity Level IV issues have no risk significance.
Exercising this type of discretion for Severity Level IV violations
does not eliminate the NRC's emphasis on compliance with requirements
nor the importance of maintaining safety. NRC inspectors will continue
to identify and document Severity Level IV violations associated with
matters they inspect. Doing so prompts licensees to take corrective
actions and assures the public that violations are not ignored. This
type of discretion is merely an option for dispositioning Severity
Level IV violations; it does not change the threshold for Severity
Level IV violations. This approach will allow licensees to dispute
violations described as NCVs.
The specific criteria for exercising NCV discretion is described in
the sections below.
a. Power Reactor Licensees. Severity Level IV violations at power
reactors will normally be dispositioned as NCVs. Notwithstanding that
this is the normal policy, the disposition of a Severity Level IV
violation as an NCV is still an exercise of discretion, in that the
agency is making a conscious decision not to issue a legal citation
(Notice of Violation) for a violation of the requirements. Severity
Level IV violations will be described in inspection reports, although
the NRC will close these violations based on their being entered into
the licensee's corrective action program. At the time a violation is
closed in an inspection report, the licensee may not have completed its
corrective actions or begun the process to identify the root cause and
develop action to prevent recurrence. Licensee actions will be taken
commensurate with the established priorities and processes of the
licensee's corrective action program. The NRC inspection program will
provide an assessment of the effectiveness of the corrective action
program. In addition to documentation in inspection reports, violations
will be entered into the Plant Issues Matrix (PIM) that the NRC
maintains for each facility to assist in identifying declining
performance and determining repetitiveness.
Because the NRC will not normally obtain a written response from
licensees describing actions taken to restore compliance and prevent
recurrence of Severity Level IV violations, this enforcement approach
places greater NRC reliance on licensee corrective action programs.
Therefore, notwithstanding the normal approach of treating most
Severity Level IV violations as NCVs, the NRC has identified four
circumstances in which a written response to a Severity Level IV
violation may be important. Any one of the following circumstances will
result in consideration of a Notice of Violation (NOV) requiring a
formal written response from a licensee.
1. The licensee failed to restore compliance within a reasonable
time after a violation was identified.
2. The licensee did not place the violation into a corrective
action program to address recurrence.
3. The violation is repetitive as a result of inadequate corrective
action, and was identified by the NRC.
4. The violation was willful. Notwithstanding willfulness, an NCV
may still be appropriate if:
(i) The licensee identified the violation and the information
concerning the violation, if not required to be reported, was promptly
provided to appropriate NRC personnel, such as a resident inspector or
regional section or branch chief;
(ii) The violation involved the acts of a low-level individual (and
not a licensee official as defined in Section IV.A);
(iii) 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; and
(iv) Significant remedial action commensurate with the
circumstances was taken by the licensee such that it demonstrated the
seriousness of the violation to other employees and contractors,
thereby creating a deterrent effect within the licensee's organization.
b.-g. [Reserved]
h. All Other Licensees. The NRC, with the approval of the Regional
Administrator or his or her designee, may refrain from issuing an NOV
for a Severity Level IV violation that is documented in an inspection
report (or official field notes for some material cases) and described
therein as an NCV provided that the inspection report includes a brief
description of the corrective action and that the violation meets all
of the following criteria:
1. It was identified by the licensee; 8
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\8\ Discretion is not warranted when a licensee 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. Discretion may be warranted if the licensee demonstrated
initiative in identifying the violation's root cause.
---------------------------------------------------------------------------
2. It was not a violation that could reasonably be expected to have
been prevented by the licensee's corrective action for a previous
violation or a previous licensee finding that occurred within the past
2 years of the inspection at issue, or the period within the last two
inspections, whichever is longer;
3. It was or will be corrected within a reasonable time, by
specific corrective action committed to by the licensee by the end of
the inspection, including immediate corrective action and comprehensive
corrective action to prevent recurrence; and
4. It was not a willful violation or if it was a willful violation;
(i) The information concerning the violation, if not required to be
reported, was promptly provided to appropriate NRC personnel, such as a
resident inspector or regional section or branch chief;
(ii) The violation involved the acts of a low-level individual (and
not a licensee official as defined in Section IV.A);
(iii) The violation appears to be the isolated action of the
employee without
[[Page 61156]]
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; and
(iv) Significant remedial action commensurate with the
circumstances was taken by the licensee such that it demonstrated the
seriousness of the violation to other employees and contractors,
thereby creating a deterrent effect within the licensee's organization.
2. Violations Identified During Extended Shutdowns or Work Stoppages
The NRC may refrain from issuing a Notice of Violation or a
proposed civil penalty for a violation that is identified after (i) the
NRC has taken significant enforcement action based upon a major safety
event contributing to an extended shutdown of an operating reactor or a
material licensee (or a work stoppage at a construction site), or (ii)
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 official field
notes for some material cases) and that it meets all of the following
criteria:
(a) It was either licensee-identified as a result of a
comprehensive program for problem identification and correction that
was developed in response to the shutdown or identified as a result of
an employee allegation to the licensee; (If the NRC identifies the
violation and all of the other criteria are met, the NRC should
determine whether enforcement action is necessary to achieve remedial
action, or if discretion may still be appropriate.)
(b) It is based upon activities of the licensee prior to the events
leading to the shutdown;
(c) It would not be categorized at Severity Level I;
(d) It was not willful; and
(e) The licensee's decision to restart the plant requires NRC
concurrence.
3. Violations Involving Old Design Issues
The NRC may refrain from proposing a civil penalty for a Severity
Level II or III violation involving a past problem, such as in
engineering, design, or installation, provided that the violation is
documented in an inspection report (or official field notes for some
material cases) that includes a description of the corrective action
and that it meets all of the following criteria:
(a) It was a licensee-identified as a result of its 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); and
(c) It was not likely to be identified (after the violation
occurred) by routine licensee efforts such as normal surveillance or
quality assurance (QA) activities.
In addition, the NRC may refrain from issuing a Notice of Violation
for a Severity Level II, III, or IV violation that meets the above
criteria provided the violation was caused by conduct that is not
reasonably linked to present performance (normally, violations that are
at least 3 years old or violations occurring during plant construction)
and there had not been prior notice so that the licensee should have
reasonably identified the violation earlier. This exercise of
discretion is to place a premium on licensees initiating efforts to
identify and correct subtle violations that are not likely to be
identified by routine efforts before degraded safety systems are called
upon to work.
Section VII.B.3 discretion would not normally be applied to
departures from the FSAR if:
(a) The NRC identifies the violation, unless it was likely in the
staff's view that the licensee would have identified the violation in
light of the defined scope, thoroughness, and schedule of the
licensee's initiative provided the schedule provides for completion of
the licensee's initiative by March 30, 2000, for risk-significant items
as defined by the licensee's maintenance rule program and by March 30,
2001, for all other issues;
(b) The licensee identifies the violation as a result of an event
or surveillance or other required testing where required corrective
action identifies the FSAR issue;
(c) The licensee identifies the violation but had prior
opportunities to do so (was aware of the departure from the FSAR) and
failed to correct it earlier;
(d) There is willfulness associated with the violation;
(e) The licensee fails to make a report required by the
identification of the departure from the FSAR; or
(f) The licensee either fails to take comprehensive corrective
action or fails to appropriately expand the corrective action program.
The corrective action should be broad with a defined scope and
schedule.
4. Violations Identified Due to Previous Enforcement Action
The NRC may refrain from issuing a Notice of Violation or a
proposed civil penalty for a violation that is identified after the NRC
has taken enforcement action, provided that the violation is documented
in an inspection report (or official field notes for some material
cases) that includes a description of the corrective action and that it
meets all of the following criteria:
(a) It was licensee-identified as part of the corrective action for
the previous enforcement action;
(b) It has the same or similar root cause as the violation for
which enforcement action was issued;
(c) It does not substantially change the safety significance or the
character of the regulatory concern arising out of the initial
violation; and
(d) 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.
(e) It would not be categorized at Severity Level I.
5. Violations Involving Certain Discrimination Issues
Enforcement discretion may be exercised for discrimination cases
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 the overall work environment for raising safety concerns.
Similarly, enforcement may not be warranted where a complaint is filed
with the Department of Labor (DOL) under Section 211 of the Energy
Reorganization Act of 1974, as amended, but the licensee settles the
matter before the DOL makes an initial finding of discrimination and
addresses the overall work environment. Alternatively, if a finding of
discrimination is made, 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 the DOL, that the matter was
settled to the satisfaction of the employee (the terms of the specific
settlement agreement need not be posted), and that, if the DOL Area
Office found discrimination, the licensee has taken action to
positively reemphasize that
[[Page 61157]]
discrimination will not be tolerated. Similarly, the NRC may refrain
from taking enforcement action if a licensee settles a matter promptly
after a person comes to the NRC without going to the DOL. Such
discretion would normally not be exercised in cases in which the
licensee does not appropriately address the overall work environment
(e.g., by using training, postings, revised policies or procedures, any
necessary disciplinary action, etc., to communicate its policy against
discrimination) or in cases that involve: allegations of discrimination
as a result of providing information directly to the NRC, allegations
of discrimination caused by a manager above first-line supervisor
(consistent with current Enforcement Policy classification of Severity
Level I or II violations), allegations of discrimination where a
history of findings of discrimination (by the DOL or the NRC) or
settlements suggests a programmatic rather than an isolated
discrimination problem, or allegations of discrimination which appear
particularly blatant or egregious.
6. Violations Involving Special Circumstances
Notwithstanding the outcome of the normal enforcement process
addressed in Section VI.A or the normal civil penalty assessment
process addressed in Section VI.B, the NRC may reduce or refrain from
issuing a civil penalty or a Notice of Violation for a Severity Level
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, the appropriateness of the requirement, the
overall sustained performance of the licensee has been particularly
good, and other relevant circumstances, including any that may have
changed since the violation. 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 quality assurance 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.
C. Notice of Enforcement Discretion for Power Reactors and Gaseous
Diffusion Plants
On occasion, circumstances may arise where a power reactor's
compliance with a Technical Specification (TS) Limiting Condition for
Operation or with other license conditions would involve an unnecessary
plant transient or performance of testing, inspection, or system
realignment that is inappropriate with the specific plant conditions,
or unnecessary delays in plant startup without a corresponding health
and safety benefit. Similarly, for a gaseous diffusion plant (GDP),
circumstances may arise where compliance with a Technical Safety
Requirement (TSR) or technical specification 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.
In these circumstances, the NRC staff may choose not to enforce the
applicable TS, TSR, or other license or certificate condition. This
enforcement discretion, designated as a Notice of Enforcement
Discretion (NOED), will only be exercised if the NRC staff is clearly
satisfied that the action is consistent with protecting the public
health and safety. The 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
Commission is to be informed expeditiously following the granting of an
NOED in such situations. A licensee or certificate holder seeking the
issuance of a NOED must provide a written justification, or in
circumstances where good cause is shown, oral justification followed as
soon as possible by written justification, which documents the safety
basis for the request and provides whatever other information the NRC
staff deems necessary in making a decision on whether to issue a NOED.
The appropriate Regional Administrator, or his or her designee, may
issue a NOED where the noncompliance is temporary and nonrecurring when
an amendment is not practical. The Director, Office of Nuclear Reactor
Regulation or Office of Nuclear Materials Safety and Safeguards, as
appropriate, or his or her designee, may issue a NOED if the expected
noncompliance will occur during the brief period of time it requires
the NRC staff to process an emergency or exigent license amendment
under the provisions of 10 CFR 50.91(a)(5) or (6) or a certificate
amendment under 10 CFR 76.45. The person exercising enforcement
discretion will document the decision.
For an operating reactor, this exercise of enforcement discretion
is intended to minimize the potential safety consequences of
unnecessary plant transients with the accompanying operational risks
and impacts or to eliminate testing, inspection, or system realignment
which is inappropriate for the particular plant conditions. For plants
in a shutdown condition, exercising enforcement discretion is intended
to reduce shutdown risk by, again, avoiding testing, inspection or
system realignment which is inappropriate for the particular plant
conditions, in that, it does not provide a safety benefit or may, in
fact, be detrimental to safety in the particular plant condition.
Exercising enforcement discretion for plants attempting to startup is
less likely than exercising it for an operating plant, as simply
delaying startup does not usually leave the plant in a condition in
which it could experience undesirable transients. In such cases, the
Commission would expect that discretion would be exercised with respect
to equipment or systems only when it has at least concluded that,
notwithstanding the conditions of the license: (1) The equipment or
system does not perform a safety function in the mode in which
operation is to occur; (2) the safety function performed by the
equipment or system is of only marginal safety benefit, provided
remaining in the current mode increases the likelihood of an
unnecessary plant transient; or (3) the TS or other license condition
requires a test, inspection or system realignment that is inappropriate
for the particular plant conditions, in that it does not provide a
safety benefit, or may, in fact, be detrimental to safety in the
particular plant condition.
For GDPs, the exercise of enforcement discretion would be used
where compliance with a certificate condition would involve an
unnecessary 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. Such regulatory flexibility is needed
because
[[Page 61158]]
a total plant shutdown is not necessarily the best response to a plant
condition. GDPs are designed to operate continuously and have never
been shut down. Although portions can be shut down for maintenance, the
staff has been informed by the certificate holder that restart from a
total plant shutdown may not be practical and the staff agrees that the
design of a GDP does not make restart practical. Hence, the decision to
place either GDP in plant-wide shutdown condition would be made only
after determining that there is inadequate safety, safeguards, or
security and considering the total impact of the shutdown on safety,
the environment, safeguards, and security. A NOED would not be used for
noncompliances with other than certificate requirements, or for
situations where the certificate holder cannot demonstrate adequate
safety, safeguards, or security.
The decision to exercise enforcement discretion 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 staff has chosen to
issue a 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. The
enforcement action is intended to emphasize that licensees and
certificate holders should not rely on the NRC's authority to exercise
enforcement discretion as a routine substitute for compliance or for
requesting a license or certificate amendment.
Finally, it is expected that the NRC staff will exercise
enforcement discretion in this area infrequently. Although a plant must
shut down, refueling activities may be suspended, or plant startup may
be delayed, absent the exercise of enforcement discretion, the NRC
staff is under no obligation to take such a step merely because it has
been requested. The decision to forego enforcement is discretionary.
When enforcement discretion is to be exercised, it is to be exercised
only if the NRC staff is clearly satisfied that such action is
warranted from a health and safety perspective.
VIII. Enforcement Actions Involving Individuals
Enforcement actions involving individuals, including licensed
operators, are significant personnel actions, which will be closely
controlled and judiciously applied. An enforcement action involving an
individual will normally be taken only when the NRC is satisfied that
the individual fully understood, or should have understood, his or her
responsibility; knew, or should have known, the required actions; and
knowingly, or with careless disregard (i.e., with more than mere
negligence) failed to take required actions which have actual or
potential safety significance. Most transgressions of individuals at
the level of Severity Level III or IV violations will be handled by
citing only the facility licensee.
More serious violations, including those involving the integrity of
an individual (e.g., lying to the NRC) concerning matters within the
scope of the individual's responsibilities, will be considered for
enforcement action against the individual as well as against the
facility licensee. Action against the individual, however, will not be
taken if the improper action by the individual was caused by management
failures. The following examples of situations illustrate this concept:
Inadvertent individual mistakes resulting from inadequate
training or guidance provided by the facility licensee.
Inadvertently missing an insignificant procedural
requirement when the action is routine, fairly uncomplicated, and there
is no unusual circumstance indicating that the procedures should be
referred to and followed step-by-step.
Compliance with an express direction of management, such
as the Shift Supervisor or Plant Manager, resulted in a violation
unless the individual did not express his or her concern or objection
to the direction.
Individual error directly resulting from following the
technical advice of an expert unless the advise was clearly
unreasonable and the licensed individual should have recognized it as
such.
Violations resulting from inadequate procedures unless the
individual used a faulty procedure knowing it was faulty and had not
attempted to get the procedure corrected.
Listed below are examples of situations which could result in
enforcement actions involving individuals, licensed or unlicensed. If
the actions described in these examples are taken by a licensed
operator or taken deliberately by an unlicensed individual, enforcement
action may be taken directly against the individual. However,
violations involving willful conduct not amounting to deliberate action
by an unlicensed individual in these situations may result in
enforcement action against a licensee that may impact an individual.
The situations include, but are not limited to, violations that
involve:
Willfully causing a licensee to be in violation of NRC
requirements.
Willfully taking action that would have caused a licensee
to be in violation of NRC requirements but the action did not do so
because it was detected and corrective action was taken.
Recognizing a violation of procedural requirements and
willfully not taking corrective action.
Willfully defeating alarms which have safety significance.
Unauthorized abandoning of reactor controls.
Dereliction of duty.
Falsifying records required by NRC regulations or by the
facility license.
Willfully providing, or causing a licensee to provide, an
NRC inspector or investigator with inaccurate or incomplete information
on a matter material to the NRC.
Willfully withholding safety significant information
rather than making such information known to appropriate supervisory or
technical personnel in the licensee's organization.
Submitting false information and as a result gaining
unescorted access to a nuclear power plant.
Willfully providing false data to a licensee by a
contractor or other person who provides test or other services, when
the data affects the licensee's compliance with 10 CFR Part 50,
Appendix B, or other regulatory requirement.
Willfully providing false certification that components
meet the requirements of their intended use, such as ASME Code.
Willfully supplying, by contractors of equipment for
transportation of radioactive material, casks that do not comply with
their certificates of compliance.
Willfully performing unauthorized bypassing of required
reactor or other facility safety systems.
Willfully taking actions that violate Technical
Specification Limiting Conditions for Operation or other license
conditions (enforcement action for a willful violation will not be
taken if that violation is the result of action taken following the
NRC's decision to forego enforcement of the Technical Specification or
other license condition or if the operator meets the requirements of 10
CFR 50.54 (x), (i.e., unless the operator acted unreasonably
considering all the relevant circumstances surrounding the emergency.)
Normally, some enforcement action is taken against a licensee for
violations
[[Page 61159]]
caused by significant acts of wrongdoing by its employees, contractors,
or contractors' employees. In deciding whether to issue an enforcement
action to an unlicensed person as well as to the licensee, the NRC
recognizes that judgments will have to be made on a case by case basis.
In making these decisions, the NRC will consider factors such as the
following:
1. The level of the individual within the organization.
2. The individual's training and experience as well as knowledge of
the potential consequences of the wrongdoing.
3. The safety consequences of the misconduct.
4. The benefit to the wrongdoer, e.g., personal or corporate gain.
5. The degree of supervision of the individual, i.e., how closely
is the individual monitored or audited, and the likelihood of detection
(such as a radiographer working independently in the field as
contrasted with a team activity at a power plant).
6. The employer's response, e.g., disciplinary action taken.
7. The attitude of the wrongdoer, e.g., admission of wrongdoing,
acceptance of responsibility.
8. The degree of management responsibility or culpability.
9. Who identified the misconduct.
Any proposed enforcement action involving individuals must be
issued with the concurrence of the Deputy Executive Director. The
particular sanction to be used should be determined on a case-by-case
basis.9 Notices of Violation and Orders are examples of
enforcement actions that may be appropriate against individuals. The
administrative action of a Letter of Reprimand may also be considered.
In addition, the NRC may issue Demands for Information to gather
information to enable it to determine whether an order or other
enforcement action should be issued.
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\9\ Except for individuals subject to civil penalties under
section 206 of the Energy Reorganization Act of 1974, as amended,
NRC will not normally impose a civil penalty against an individual.
However, section 234 of the Atomic Energy Act (AEA) gives the
Commission authority to impose civil penalties on ``any person.''
``Person'' is broadly defined in Section 11s of the AEA to include
individuals, a variety of organizations, and any representatives or
agents. This gives the Commission authority to impose civil
penalties on employees of licensees or on separate entities when a
violation of a requirement directly imposed on them is committed.
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Orders to NRC-licensed reactor operators may involve suspension for
a specified period, modification, or revocation of their individual
licenses. Orders to unlicensed individuals might include provisions
that would;
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.
Require notification to the NRC before resuming work in
licensed activities.
Require the person to tell a prospective employer or
customer engaged in licensed activities that the person has been
subject to an NRC order.
In the case of a licensed operator's failure to meet applicable
fitness-for-duty requirements (10 CFR 55.53(j)), the NRC may issue a
Notice of Violation or a civil penalty to the Part 55 licensee, or an
order to suspend, modify, or revoke the Part 55 license. These actions
may be taken the first time a licensed operator fails a drug or alcohol
test, that is, receives a confirmed positive test that exceeds the
cutoff levels of 10 CFR Part 26 or the facility licensee's cutoff
levels, if lower. However, normally only a Notice of Violation will be
issued for the first confirmed positive test in the absence of
aggravating circumstances such as errors in the performance of licensed
duties or evidence of prolonged use. In addition, the NRC intends to
issue an order to suspend the Part 55 license for up to 3 years the
second time a licensed operator exceeds those cutoff levels. In the
event there are less than 3 years remaining in the term of the
individual's license, the NRC may consider not renewing the
individual's license or not issuing a new license after the three year
period is completed. The NRC intends to issue an order to revoke the
Part 55 license the third time a licensed operator exceeds those cutoff
levels. A licensed operator or applicant who refuses to participate in
the drug and alcohol testing programs established by the facility
licensee or who is involved in the sale, use, or possession of an
illegal drug is also subject to license suspension, revocation, or
denial.
In addition, the NRC may take enforcement action against a licensee
that may impact an individual, where the conduct of the individual
places in 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 of integrity, competence,
fitness-for-duty, or other matters that may not necessarily be a
violation of specific Commission requirements.
In the case of an unlicensed person, whether a firm or an
individual, an order modifying the facility license may be issued to
require (1) the removal of the person from all licensed activities for
a specified period of time or indefinitely, (2) prior notice to the NRC
before utilizing the person in licensed activities, or (3) the licensee
to provide notice of the issuance of such an order to other persons
involved in licensed activities making reference inquiries. In
addition, orders to employers might require retraining, additional
oversight, or independent verification of activities performed by the
person, if the person is to be involved in licensed activities.
IX. Inaccurate and Incomplete Information
A violation of the regulations involving submittal of incomplete
and/or inaccurate information, whether or not considered a material
false statement, 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 normally will be categorized based on the guidance herein, in
Section IV, ``Significance of Violations,'' and in Supplement VII.
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 licensee officials concerning significant information. Therefore,
in determining whether to take enforcement action for an oral
statement, consideration may be given to 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 prior to the communication to assure
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 which was wrong or
not provided; and (7) the reasonableness of the explanation for not
providing complete and accurate information.
[[Page 61160]]
Absent 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 official. However, enforcement action may be taken for an
unintentionally incomplete or inaccurate oral statement provided to the
NRC by a licensee official or others on behalf of a licensee, if a
record was made of the oral information and provided to the licensee
thereby permitting an opportunity to correct the oral information, such
as if a transcript of the communication or meeting summary containing
the error was made available to the licensee and was not subsequently
corrected in a timely manner.
When a licensee has corrected inaccurate or incomplete information,
the decision to issue a Notice of Violation for the initial inaccurate
or incomplete information normally will be dependent on the
circumstances, including the ease of detection of the error, the
timeliness of the correction, whether the NRC or the licensee
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 prior to
reliance by the NRC, or before the NRC raised 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 it is in fact
corrected. However, if the initial submittal was accurate when made but
later turns out to be erroneous because of newly discovered information
or advance in technology, a citation normally would not be appropriate
if, when the new information became available or the advancement in
technology was made, the initial submittal was corrected.
The failure to correct inaccurate or incomplete information which
the licensee 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 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
information not corrected was recognized by a licensee as significant,
a separate citation may be made for the failure to provide significant
information. In any event, in serious cases where the licensee's
actions in not correcting or providing information raise questions
about its commitment to safety or its fundamental trustworthiness, the
Commission may exercise its authority to issue orders modifying,
suspending, or revoking the license. The Commission recognizes that
enforcement determinations must be made on a case-by-case basis, taking
into consideration the issues described in this section.
X. Enforcement Action Against Non-Licensees
The Commission's enforcement policy is also applicable to non-
licensees, including contractors and subcontractors, holders of NRC
approvals, e.g., certificates of compliance, early site permits,
standard design certificates, quality assurance program approvals, or
applicants for any of them, and to employees of any of the foregoing,
who knowingly provide components, equipment, or other goods or services
that relate to a licensee's activities subject to NRC regulation. The
prohibitions and sanctions for any of these persons who engage in
deliberate misconduct or knowing submission of incomplete or inaccurate
information are provided in the rule on deliberate misconduct, e.g., 10
CFR 30.10 and 50.5.
Contractors who supply products or services provided for use in
nuclear activities are subject to certain requirements designed to
ensure that the products or services supplied that could affect safety
are of high quality. Through procurement contracts with licensees,
suppliers may be required to have quality assurance programs that meet
applicable requirements, e.g., 10 CFR Part 50, Appendix B, and 10 CFR
Part 71, Subpart H. Contractors supplying certain products or services
to licensees are subject to the requirements of 10 CFR Part 21
regarding reporting of defects in basic components.
When inspections determine that violations of NRC requirements have
occurred, or that contractors have failed to fulfill contractual
commitments (e.g., 10 CFR Part 50, Appendix B) that could adversely
affect the quality of a safety significant product or service,
enforcement action will be taken. Notices of Violation and civil
penalties will be used, as appropriate, for licensee failures to ensure
that their contractors have programs that meet applicable requirements.
Notices of Violation will be issued for contractors who violate 10 CFR
Part 21. Civil penalties will be imposed against individual directors
or responsible officers of a contractor organization who knowingly and
consciously fail to provide the notice required by 10 CFR 21.21(d)(1).
Notices of Violation or orders will be used against non-licensees who
are subject to the specific requirements of Part 72. 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.
XI. Referrals to the Department of Justice
Alleged or suspected criminal violations of the Atomic Energy Act
(and of other relevant Federal laws) are referred to the Department of
Justice (DOJ) for investigation. Referral to the DOJ does not preclude
the NRC from taking other enforcement action under this policy.
However, enforcement actions will be coordinated with the DOJ in
accordance with the Memorandum of Understanding between the NRC and the
DOJ, 53 FR 50317 (December 14, 1988).
XII. Public Disclosure of Enforcement Actions
Enforcement actions and licensees' responses, in accordance with 10
CFR 2.790, are publicly available for inspection. In addition, press
releases are generally issued for orders and civil penalties and are
issued at the same time the order or proposed imposition of the civil
penalty is issued. In addition, press releases are usually issued when
a proposed civil penalty is withdrawn or substantially mitigated by
some amount. Press releases are not normally issued for Notices of
Violation that are not accompanied by orders or proposed civil
penalties.
XIII. Reopening Closed Enforcement Actions
If significant new information is received or obtained by NRC which
indicates that an enforcement sanction was incorrectly applied,
consideration may be given, dependent on the circumstances, to
reopening a closed enforcement action to increase or decrease the
severity of a sanction or to correct the record. Reopening decisions
will be made on a case-by-case basis, are expected to occur rarely, and
require the specific approval of the Deputy Executive Director.
[[Page 61161]]
Supplements--Violation Examples
This section provides examples of violations in each of four
severity levels as guidance in determining the appropriate severity
level for violations in each of eight activity areas (reactor
operations, Part 50 facility construction, safeguards, health physics,
transportation, fuel cycle and materials operations, miscellaneous
matters, and emergency preparedness).
Supplement I--Reactor Operations
This supplement provides examples of violations in each of the
four severity levels as guidance in determining the appropriate
severity level for violations in the area of reactor operations.
A. Severity Level I--Violations involving for example:
1. A Safety Limit, as defined in 10 CFR 50.36 and the Technical
Specifications being exceeded;
2. A system 10 designed to prevent or mitigate a
serious safety event not being able to perform its intended safety
function 11 when actually called upon to work;
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\10\ The term ``system'' as used in these supplements, includes
administrative and managerial control systems, as well as physical
systems.
\11\ ``Intended 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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3. An accidental criticality; or
4. A licensed operator at the controls of a nuclear reactor, or
a senior operator directing licensed activities, involved in
procedural errors which result in, or exacerbate the consequences
of, an alert or higher level emergency and who, as a result of
subsequent testing, receives a confirmed positive test result for
drugs or alcohol.
B. Severity Level II--Violations involving for example:
1. A system designed to prevent or mitigate serious safety
events not being able to perform its intended safety function;
2. A licensed operator involved in the use, sale, or possession
of illegal drugs or the consumption of alcoholic beverages, within
the protected area; or
3. A licensed operator at the control of a nuclear reactor, or a
senior operator directing licensed activities, involved in
procedural errors and who, as a result of subsequent testing,
receives a confirmed positive test result for drugs or alcohol.
C. Severity Level III--Violations involving for example:
1. A significant failure to comply with the Action Statement for
a Technical Specification Limiting Condition for Operation where the
appropriate action was not taken within the required time, such as:
(a) In a pressurized water reactor, in the applicable modes,
having one high-pressure safety injection pump inoperable for a
period in excess of that allowed by the action statement; or
(b) In a boiling water reactor, one primary containment
isolation valve inoperable for a period in excess of that allowed by
the action statement.
2. A system designed to prevent or mitigate a serious safety
event not being able to perform its intended function under certain
conditions (e.g., safety system not operable unless offsite power is
available; materials or components not environmentally qualified).
3. Inattentiveness to duty on the part of licensed personnel;
4. Changes in reactor parameters that cause unanticipated
reductions in margins of safety;
5. A non-willful compromise of an application, test, or
examination required by 10 CFR Part 55 that:
(a) In the case of initial operator licensing, contributes to an
individual being granted an operator or a senior operator license,
or
(b) In the case of requalification, contributes to an individual
being permitted to perform the functions of an operator or a senior
operator.
6. A licensee failure to conduct adequate oversight of
contractors resulting in the use of products or services that are of
defective or indeterminate quality and that have safety
significance;
7. A licensed operator's confirmed positive test for drugs or
alcohol that does not result in a Severity Level I or II violation;
8. Equipment failures caused by inadequate or improper
maintenance that substantially complicates recovery from a plant
transient;
9. A failure to obtain prior Commission approval required by 10
CFR 50.59 for changes that would not be found acceptable by the
Commission;
10. The failure to update the FSAR as required by 10 CFR
50.71(e) where the unupdated FSAR was used in performing a 10 CFR
50.59 evaluation for a change to the facility or procedures,
implemented without prior Commission approval, that would not be
found acceptable had approval been sought; or
11. The failure to make a report required by 10 CFR 50.72 or
50.73 associated with any Severity Level III violation.
D. Severity Level IV--Violations involving for example:
1. A less significant failure to comply with the Action
Statement for a Technical Specification Limiting Condition for
Operation where the appropriate action was not taken within the
required time, such as:
(a) In a pressurized water reactor, a 5% deficiency in the
required volume of the condensate storage tank; or
(b) In a boiling water reactor, one subsystem of the two
independent MSIV leakage control subsystems inoperable;
2. A non-willful compromise of an application, test, or
examination required by 10 CFR Part 55 that:
(a) In the case of initial operator licensing, is discovered and
reported to the NRC before an individual is granted an operator or a
senior operator license, or
(b) In the case of requalification, is discovered and reported
to the NRC before an individual is permitted to perform the
functions of an operator or a senior operator, or
(c) Constitutes more than minor concern.
3. A failure to meet regulatory requirements that have more than
minor safety or environmental significance;
4. A failure to make a required Licensee Event Report;
5. Violations of 10 CFR 50.59 that do not involve circumstances
in which a change that required prior Commission approval would not
be found acceptable had the approval been sought; or
6. A failure to update the FSAR as required by 10 CFR 50.71(e)
in cases where the erroneous information is not used to make an
unacceptable change to the facility or procedures.
E. Minor Violations: A failure to meet 10 CFR 50.59 requirements
that involves a change to the FSAR description or procedure, or
involves a test or experiment not described in the FSAR, where there
was not a reasonable likelihood that the change to the facility or
procedure or the conduct of the test or experiment would ever be an
unreviewed safety question. In the case of a 10 CFR 50.71(e)
violation, where a failure to update the FSAR would not have a
material impact on safety or licensed activities. The focus of the
minor violation is not on the actual change, test, or experiment,
but on the potential safety role of the system, equipment, etc.,
that is being changed, tested, or experimented on.
Supplement II--Part 50 Facility Construction
This supplement provides examples of violations in each of the
four severity levels as guidance in determining the appropriate
severity level for violations in the area of Part 50 facility
construction.
A. Severity Level I--Violations involving structures or systems
that are completed 12 in such a manner that they would
not have satisfied their intended safety related purpose.
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\12\ The term ``completed'' as used in this supplement means
completion of construction including review and acceptance by the
construction QA organization.
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B. Severity Level II--Violations involving for example:
1. A breakdown in the Quality Assurance (QA) program as
exemplified by deficiencies in construction QA related to more than
one work activity (e.g., structural, piping, electrical,
foundations). These deficiencies normally involve the licensee's
failure to conduct adequate audits or to take prompt corrective
action on the basis of such audits and normally involve multiple
examples of deficient construction or construction of unknown
quality due to inadequate program implementation; or
2. A structure or system that is completed in such a manner that
it could have an adverse effect on the safety of operations.
C. Severity Level III--Violations involving for example:
1. A deficiency in a licensee QA program for construction
related to a single work activity (e.g., structural, piping,
electrical or foundations). This significant deficiency normally
involves the licensee's failure to conduct adequate audits or to
take prompt corrective action on the basis of such audits,
[[Page 61162]]
and normally involves multiple examples of deficient construction or
construction of unknown quality due to inadequate program
implementation;
2. A failure to confirm the design safety requirements of a
structure or system as a result of inadequate preoperational test
program implementation; or
3. A failure to make a required 10 CFR 50.55(e) report.
D. Severity Level IV--Violations involving failure to meet
regulatory requirements including one or more Quality Assurance
Criterion not amounting to Severity Level I, II, or III violations
that have more than minor safety or environmental significance.
Supplement III--Safeguards
This supplement provides examples of violations in each of the
four severity levels as guidance in determining the appropriate
severity level for violations in the area of safeguards.
A. Severity Level I--Violations involving for example:
1. An act of radiological sabotage in which the security system
did not function as required and, as a result of the failure, there
was a significant event, such as:
(a) A Safety Limit, as defined in 10 CFR 50.36 and the Technical
Specifications, was exceeded;
(b) A system designed to prevent or mitigate a serious safety
event was not able to perform its intended safety function when
actually called upon to work; or
(c) An accidental criticality occurred;
2. The theft, loss, or diversion of a formula quantity
13 of special nuclear material (SNM); or
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\13\ See 10 CFR 73.2 for the definition of ``formula quantity.''
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3. Actual unauthorized production of a formula quantity of SNM
B. Severity Level II--Violations involving for example:
1. The entry of an unauthorized individual 14 who
represents a threat into a vital area 15 from outside the
protected area;
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\14\ The term ``unauthorized individual'' as used in this
supplement means someone who was not authorized for entrance into
the area in question, or not authorized to enter in the manner
entered.
\15\ The phrase ``vital area'' as used in this supplement
includes vital areas and material access areas.
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2. The theft, loss or diversion of SNM of moderate strategic
significance 16 in which the security system did not
function as required; or
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\16\ See 10 CFR 73.2 for the definition of ``special nuclear
material of moderate strategic significance.''
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3. Actual unauthorized production of SNM.
C. Severity Level III--Violations involving for example:
1. A failure or inability to control access through established
systems or procedures, such that an unauthorized individual (i.e.,
not authorized unescorted access to protected area) could easily
gain undetected access 17 into a vital area from outside
the protected area;
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\17\ In determining whether access can be easily gained, factors
such as predictability, identifiability, and ease of passage should
be considered.
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2. A failure to conduct any search at the access control point
or conducting an inadequate search that resulted in the introduction
to the protected area of firearms, explosives, or incendiary devices
and reasonable facsimiles thereof that could significantly assist
radiological sabotage or theft of strategic SNM;
3. A failure, degradation, or other deficiency of the protected
area intrusion detection or alarm assessment systems such that an
unauthorized individual who represents a threat could predictably
circumvent the system or defeat a specific zone with a high degree
of confidence without insider knowledge, or other significant
degradation of overall system capability;
4. A significant failure of the safeguards systems designed or
used to prevent or detect the theft, loss, or diversion of strategic
SNM;
5. A failure to protect or control classified or safeguards
information considered to be significant while the information is
outside the protected area and accessible to those not authorized
access to the protected area;
6. A significant failure to respond to an event either in
sufficient time to provide protection to vital equipment or
strategic SNM, or with an adequate response force; or
7. A failure to perform an appropriate evaluation or background
investigation so that information relevant to the access
determination was not obtained or considered and as a result a
person, who would likely not have been granted access by the
licensee, if the required investigation or evaluation had been
performed, was granted access.
D. Severity Level IV--Violations involving for example:
1. A failure or inability to control access such that an
unauthorized individual (i.e., authorized to protected area but not
to vital area) could easily gain undetected access into a vital area
from inside the protected area or into a controlled access area;
2. A failure to respond to a suspected event in either a timely
manner or with an adequate response force;
3. A failure to implement 10 CFR Parts 25 and 95 with respect to
the information addressed under Section 142 of the Act, and the NRC
approved security plan relevant to those parts;
4. A failure to conduct a proper search at the access control
point;
5. A failure to properly secure or protect classified or
safeguards information inside the protected area which could assist
an individual in an act of radiological sabotage or theft of
strategic SNM where the information was not removed from the
protected area;
6. A failure to control access such that an opportunity exists
that could allow unauthorized and undetected access into the
protected area but which was neither easily or likely to be
exploitable;
7. A failure to conduct an adequate search at the exit from a
material access area;
8. A theft or loss of SNM of low strategic significance that was
not detected within the time period specified in the security plan,
other relevant document, or regulation; or
9. Other violations that have more than minor safeguards
significance.
Supplement IV--Health Physics (10 CFR Part 20)
This supplement provides examples of violations in each of the
four severity levels as guidance in determining the appropriate
severity level for violations in the area of health physics, 10 CFR
Part 20.18
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\18\ Personnel overexposures and associated violations incurred
during a life-saving or other emergency response effort will be
treated on a case-by-case basis.
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A. Severity Level I--Violations involving for example:
1. A radiation exposure during any year of a worker in excess of
25 rems total effective dose equivalent, 75 rems to the lens of the
eye, or 250 rads to the skin of the whole body, or to the feet,
ankles, hands or forearms, or to any other organ or tissue;
2. A radiation exposure over the gestation period of the embryo/
fetus of a declared pregnant woman in excess of 2.5 rems total
effective dose equivalent;
3. A radiation exposure during any year of a minor in excess of
2.5 rems total effective dose equivalent, 7.5 rems to the lens of
the eye, or 25 rems 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 1.0
rem total effective dose equivalent;
5. A release of radioactive material to an unrestricted area at
concentrations in excess of 50 times the limits for members of the
public as described in 10 CFR 20.1302(b)(2)(i); or
6. Disposal of licensed material in quantities or concentrations
in excess of 10 times the limits of 10 CFR 20.2003.
B. Severity Level II--Violations involving for example:
1. A radiation exposure during any year of a worker in excess of
10 rems total effective dose equivalent, 30 rems to the lens of the
eye, or 100 rems to the skin of the whole body, or to the feet,
ankles, hands or forearms, or to any other organ or tissue;
2. A radiation exposure over the gestation period of the embryo/
fetus of a declared pregnant woman in excess of 1.0 rem total
effective dose equivalent;
3. A radiation exposure during any year of a minor in excess of
1 rem total effective dose equivalent; 3.0 rems to the lens of the
eye, or 10 rems 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 0.5
rem total effective dose equivalent;
5. A release of radioactive material to an unrestricted area at
concentrations in excess of 10 times the limits for members of the
public as described in 10 CFR 20.1302(b)(2)(i) (except when
operation up to 0.5 rem a year has been approved by the Commission
under Section 20.1301(c));
6. Disposal of licensed material in quantities or concentrations
in excess of five times the limits of 10 CFR 20.2003; or
[[Page 61163]]
7. A failure to make an immediate notification as required by 10
CFR 20.2202 (a)(1) or (a)(2).
C. Severity Level III--Violations involving for example:
1. A radiation exposure during any year of a worker in excess of
5 rems total effective dose equivalent, 15 rems to the lens of the
eye, or 50 rems to the skin of the whole body or to the feet,
ankles, hands or forearms, or to any other organ or tissue;
2. A radiation exposure over the gestation period of the embryo/
fetus of a declared pregnant woman in excess of 0.5 rem total
effective dose equivalent (except when doses are in accordance with
the provisions of Section 20.1208(d));
3. A radiation exposure during any year of a minor in excess of
0.5 rem total effective dose equivalent; 1.5 rems to the lens of the
eye, or 5 rems 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 total effective dose equivalent (except when operation up to 0.5
rem a year has been approved by the Commission under Section
20.1301(c));
5. A release of radioactive material to an unrestricted area at
concentrations in excess of two times the effluent concentration
limits referenced in 10 CFR 20.1302(b)(2)(i) (except when operation
up to 0.5 rem a year has been approved by the Commission under
Section 20.1301(c));
6. A 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);
7. A substantial potential for exposures or releases in excess
of the applicable limits in 10 CFR Part 20 Sections 20.1001-20.2401
whether or not an exposure or release occurs;
8. Disposal of licensed material not covered in Severity Levels
I or II;
9. A release for unrestricted use of contaminated or radioactive
material or equipment that poses a realistic potential for exposure
of the public to levels or doses exceeding the annual dose limits
for members of the public;
10. Conduct of licensee activities by a technically unqualified
person; or
11. A significant failure to control licensed material.
D. Severity Level IV--Violations involving for example:
1. Exposures in excess of the limits of 10 CFR 20.1201, 20.1207,
or 20.1208 not constituting Severity Level I, II, or III violations;
2. A release of radioactive material to an unrestricted area at
concentrations in excess of the limits for members of the public as
referenced in 10 CFR 20.1302(b)(2)(i) (except when operation up to
0.5 rem a year has been approved by the Commission under Section
20.1301(c));
3. A radiation dose rate in an unrestricted or controlled area
in excess of 0.002 rem in any 1 hour (2 millirem/hour) or 50
millirems in a year;
4. Failure to maintain and implement radiation programs to keep
radiation exposures as low as is reasonably achievable;
5. Doses to a member of the public in excess of any EPA
generally applicable environmental radiation standards, such as 40
CFR Part 190;
6. A failure to make the 30-day notification required by 10 CFR
20.2201(a)(1)(ii) or 20.2203(a);
7. A failure to make a timely written report as required by 10
CFR 20.2201(b), 20.2204, or 20.2206;
8. A failure to report an exceedance of the dose constraint
established in 10 CFR 20.1101(d) or a failure to take corrective
action for an exceedance, as required by 10 CFR 20.1101(d); or
9. Any other matter that has more than a minor safety, health,
or environmental significance.
Supplement V--Transportation
This supplement provides examples of violations in each of the
four severity levels as guidance in determining the appropriate
severity level for violations in the area of NRC transportation
requirements.19
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\19\ Some transportation requirements are applied to more than
one licensee involved in the same activity such as a shipper and
carrier. When a violation of such a requirement occurs, enforcement
action will be directed against the responsible licensee which,
under the circumstances of the case, may be one or more of the
licensees involved.
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A. Severity Level I--Violations involving for example:
1. Failure to meet transportation requirements that resulted in
loss of control of radioactive material with a breach in package
integrity such that the material caused a radiation exposure to a
member of the public and there was clear potential for the public to
receive more than .1 rem to the whole body;
2. Surface contamination in excess of 50 times the NRC limit; or
3. External radiation levels in excess of 10 times the NRC
limit.
B. Severity Level II--Violations involving for example:
1. Failure to meet transportation requirements that resulted in
loss of control of radioactive material with a breach in package
integrity such that there was a clear potential for the member of
the public to receive more than .1 rem to the whole body;
2. Surface contamination in excess of 10, but not more than 50
times the NRC limit;
3. External radiation levels in excess of five, but not more
than 10 times the NRC limit; or
4. A failure to make required initial notifications associated
with Severity Level I or II violations.
C. Severity Level III--Violations involving for example:
1. Surface contamination in excess of five but not more than 10
times the NRC limit;
2. External radiation in excess of one but not more than five
times the NRC limit;
3. Any noncompliance with labeling, placarding, shipping paper,
packaging, loading, or other requirements that could reasonably
result in the following:
(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; or
(c) A substantial potential for either personnel exposure or
contamination above regulatory limits or improper transfer of
material; or
4. A failure to make required initial notification associated
with Severity Level III violations.
D. Severity Level IV--Violations involving for example:
1. A breach of package integrity without external radiation
levels exceeding the NRC limit or without contamination levels
exceeding five times the NRC limits;
2. Surface contamination in excess of but not more than five
times the NRC limit;
3. A failure to register as an authorized user of an NRC-
Certified Transport package;
4. A noncompliance with shipping papers, marking, labeling,
placarding, packaging or loading not amounting to a Severity Level
I, II, or III violation;
5. A failure to demonstrate that packages for special form
radioactive material meets applicable regulatory requirements;
6. A failure to demonstrate that packages meet DOT
Specifications for 7A Type A packages; or
7. Other violations that have more than minor safety or
environmental significance.
Supplement VI--Fuel Cycle and Materials Operations
This supplement provides examples of violations in each of the
four severity levels as guidance in determining the appropriate
severity level for violations in the area of fuel cycle and
materials operations.
A. Severity Level I--Violations involving for example:
1. Radiation levels, contamination levels, or releases that
exceed 10 times the limits specified in the license;
2. A system designed to prevent or mitigate a serious safety
event not being operable when actually required to perform its
design function;
3. A nuclear criticality accident;
4. A failure to follow the procedures of the quality management
program, required by 10 CFR 35.32, that results in a death or
serious injury (e.g., substantial organ impairment) to a patient;
5. A safety limit, as defined in 10 CFR 76.4, the Technical
Safety Requirements, or the application being exceeded; or
6. Significant injury or loss of life due to a loss of control
over licensed or certified activities, including chemical processes
that are integral to the licensed or certified activity, whether
radioactive material is released or not.
B. Severity Level II--Violations involving for example:
1. Radiation levels, contamination levels, or releases that
exceed five times the limits specified in the license;
2. A system designed to prevent or mitigate a serious safety
event being inoperable;
3. A substantial programmatic failure in the implementation of
the quality management program required by 10 CFR 35.32 that results
in a misadministration;
4. A failure to establish, implement, or maintain all
criticality controls (or control systems) for a single nuclear
criticality scenario when a critical mass of fissile material was
present or reasonably available, such that a nuclear criticality
accident was possible; or
[[Page 61164]]
5. The potential for a significant injury or loss of life due to
a loss of control over licensed or certified activities, including
chemical processes that are integral to the licensed or certified
activity, whether radioactive material is released or not (e.g.,
movement of liquid UF6 cylinder by unapproved methods).
C. Severity Level III--Violations involving for example:
1. A failure to control access to licensed materials for
radiation protection purposes as specified by NRC requirements;
2. Possession or use of unauthorized equipment or materials in
the conduct of licensee activities which degrades safety;
3. Use of radioactive material on humans where such use is not
authorized;
4. Conduct of licensed activities by a technically unqualified
or uncertified person;
5. A substantial potential for exposures, radiation levels,
contamination levels, or releases, including releases of toxic
material caused by a failure to comply with NRC regulations, from
licensed or certified activities in excess of regulatory limits;
6. Substantial failure to implement the quality management
program as required by 10 CFR 35.32 that does not result in a
misadministration; failure to report a misadministration; or
programmatic weakness in the implementation of the quality
management program that results in a misadministration;
7. A failure, during radiographic operations, to have present at
least two qualified individuals or to use radiographic equipment,
radiation survey instruments, and/or personnel monitoring devices as
required by 10 CFR Part 34;
8. A failure to submit an NRC Form 241 as required by 10 CFR
150.20;
9. A failure to receive required NRC approval prior to the
implementation of a change in licensed activities that has
radiological or programmatic significance, such as, a change in
ownership; lack of an RSO or replacement of an RSO with an
unqualified individual; a change in the location where licensed
activities are being conducted, or where licensed material is being
stored where the new facilities do not meet the safety guidelines;
or a change in the quantity or type of radioactive material being
processed or used that has radiological significance;
10. A significant failure to meet decommissioning requirements
including a failure to notify the NRC as required by regulation or
license condition, substantial failure to meet decommissioning
standards, failure to conduct and/or complete decommissioning
activities in accordance with regulation or license condition, or
failure to meet required schedules without adequate justification;
11. A significant failure to comply with the action statement
for a Technical Safety Requirement Limiting Condition for Operation
where the appropriate action was not taken within the required time,
such as:
(a) In an autoclave, where a containment isolation valve is
inoperable for a period in excess of that allowed by the action
statement; or
(b) Cranes or other lifting devices engaged in the movement of
cylinders having inoperable safety components, such as redundant
braking systems, or other safety devices for a period in excess of
that allowed by the action statement;
12. A system designed to prevent or mitigate a serious safety
event:
(a) Not being able to perform its intended function under
certain conditions (e.g., safety system not operable unless
utilities available, materials or components not according to
specifications); or
(b) Being degraded to the extent that a detailed evaluation
would be required to determine its operability;
13. Changes in parameters that cause unanticipated reductions in
margins of safety;
14. A significant failure to meet the requirements of 10 CFR
76.68, including a failure such that a required certificate
amendment was not sought;
15. A failure of the certificate holder to conduct adequate
oversight of contractors resulting in the use of products or
services that are of defective or indeterminate quality and that
have safety significance;
16. Equipment failures caused by inadequate or improper
maintenance that substantially complicates recovery from a plant
transient;
17. A failure to establish, maintain, or implement all but one
criticality control (or control systems) for a single nuclear
criticality scenario when a critical mass of fissile material was
present or reasonably available, such that a nuclear criticality
accident was possible; or
18. A failure, during radiographic operations, to stop work
after a pocket dosimeter is found to have gone off-scale, or after
an electronic dosimeter reads greater than 200 mrem, and before a
determination is made of the individual's actual radiation exposure.
D. Severity Level IV--Violations involving for example:
1. A failure to maintain patients hospitalized who have cobalt-
60, cesium-137, or iridium-192 implants or to conduct required
leakage or contamination tests, or to use properly calibrated
equipment;
2. Other violations that have more than minor safety or
environmental significance;
3. Failure to follow the quality management (QM) program,
including procedures, whether or not a misadministration occurs,
provided the failures are isolated, do not demonstrate a
programmatic weakness in the implementation of the QM program, and
have limited consequences if a misadministration is involved;
failure to conduct the required program review; or failure to take
corrective actions as required by 10 CFR 35.32;
4. A failure to keep the records required by 10 CFR 35.32 or
35.33;
5. A less significant failure to comply with the Action
Statement for a Technical Safety Requirement Limiting Condition for
Operation when the appropriate action was not taken within the
required time;
6. A failure to meet the requirements of 10 CFR 76.68 that does
not result in a Severity Level I, II, or III violation;
7. A failure to make a required written event report, as
required by 10 CFR 76.120(d)(2); or
8. A failure to establish, implement, or maintain a criticality
control (or control system) for a single nuclear criticality
scenario when the amount of fissile material available was not, but
could have been sufficient to result in a nuclear criticality.
Supplement VII--Miscellaneous Matters
This supplement provides examples of violations in each of the
four severity levels as guidance in determining the appropriate
severity level for violations involving miscellaneous matters.
A. Severity Level I--Violations involving for example:
1. Inaccurate or incomplete information 20 that is
provided to the NRC (a) deliberately with the knowledge of a
licensee official that the information is incomplete or inaccurate,
or (b) if the information, had it been complete and accurate at the
time provided, likely would have resulted in regulatory action such
as an immediate order required by the public health and safety;
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\20\ In applying the examples in this supplement regarding
inaccurate or incomplete information and records, reference should
also be made to the guidance in Section IX, ``Inaccurate and
Incomplete Information,'' and to the definition of ``licensee
official'' contained in Section IV.C.
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2. Incomplete or inaccurate information that the NRC requires be
kept by a licensee that is (a) incomplete or inaccurate because of
falsification by or with the knowledge of a licensee official, or
(b) if the information, had it been complete and accurate when
reviewed by the NRC, likely would have resulted in regulatory action
such as an immediate order required by public health and safety
considerations;
3. Information that the licensee has identified as having
significant implications for public health and safety or the common
defense and security (``significant information identified by a
licensee'') and is deliberately withheld from the Commission;
4. Action by senior corporate management in violation of 10 CFR
50.7 or similar regulations against an employee;
5. A knowing and intentional failure to provide the notice
required by 10 CFR Part 21; or
6. A failure to substantially implement the required fitness-
for-duty program.21
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\21\ The example for violations for fitness-for-duty relate to
violations of 10 CFR Part 26.
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B. Severity Level II--Violations involving for example:
1. Inaccurate or incomplete information that is provided to the
NRC (a) by a licensee official because of careless disregard for the
completeness or accuracy of the information, or (b) if the
information, had it been complete and accurate at the time provided,
likely would have resulted in regulatory action such as a show cause
order or a different regulatory position;
2. Incomplete or inaccurate information that the NRC requires be
kept by a licensee which is (a) incomplete or inaccurate because of
careless disregard for the accuracy of the
[[Page 61165]]
information on the part of a licensee official, or (b) if the
information, had it been complete and accurate when reviewed by the
NRC, likely would have resulted in regulatory action such as a show
cause order or a different regulatory position;
3. ``Significant information identified by a licensee'' and not
provided to the Commission because of careless disregard on the part
of a licensee official;
4. An action by plant management or mid-level management in
violation of 10 CFR 50.7 or similar regulations against an employee;
5. A failure to provide the notice required by 10 CFR Part 21;
6. A failure to remove an individual from unescorted access who
has been involved in the sale, use, or possession of illegal drugs
within the protected area or take action for on duty misuse of
alcohol, prescription drugs, or over-the-counter drugs;
7. A failure to take reasonable action when observed behavior
within the protected area or credible information concerning
activities within the protected area indicates possible unfitness
for duty based on drug or alcohol use;
8. A deliberate failure of the licensee's Employee Assistance
Program (EAP) to notify licensee's management when EAP's staff is
aware that an individual's condition may adversely affect safety
related activities; or
9. The failure of licensee management to take effective action
in correcting a hostile work environment.
C. Severity Level III--Violations involving for example:
1. Incomplete or inaccurate information that is provided to the
NRC (a) because of inadequate actions on the part of licensee
officials but not amounting to a Severity Level I or II violation,
or (b) if the information, had it been complete and accurate at the
time provided, likely would have resulted in a reconsideration of a
regulatory position or substantial further inquiry such as an
additional inspection or a formal request for information;
2. Incomplete or inaccurate information that the NRC requires be
kept by a licensee that is (a) incomplete or inaccurate because of
inadequate actions on the part of licensee officials but not
amounting to a Severity Level I or II violation, or (b) if the
information, had it been complete and accurate when reviewed by the
NRC, likely would have resulted in a reconsideration of a regulatory
position or substantial further inquiry such as an additional
inspection or a formal request for information;
3. A failure to provide ``significant information identified by
a licensee'' to the Commission and not amounting to a Severity Level
I or II violation;
4. An action by first-line supervision or other low-level
management in violation of 10 CFR 50.7 or similar regulations
against an employee;
5. 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 made;
6. A failure to complete a suitable inquiry on the basis of 10
CFR Part 26, keep records concerning the denial of access, or
respond to inquiries concerning denials of access so that, as a
result of the failure, a person previously denied access for
fitness-for-duty reasons was improperly granted access;
7. A failure to take the required action for a person confirmed
to have been tested positive for illegal drug use or take action for
onsite alcohol use; not amounting to a Severity Level II violation;
8. A failure to assure, as required, that contractors have an
effective fitness-for-duty program; or
9. Threats of discrimination or restrictive agreements which are
violations under NRC regulations such as 10 CFR 50.7(f).
D. Severity Level IV--Violations involving for example:
1. Incomplete or inaccurate information of more than minor
significance that is provided to the NRC but not amounting to a
Severity Level I, II, or III violation;
2. Information that the NRC requires be kept by a licensee and
that is incomplete or inaccurate and of more than minor significance
but not amounting to a Severity Level I, II, or III violation;
3. An inadequate review or failure to review under 10 CFR Part
21 or other procedural violations associated with 10 CFR Part 21
with more than minor safety significance;
4. Violations of the requirements of Part 26 of more than minor
significance;
5. A failure to report acts of licensed operators or supervisors
pursuant to 10 CFR 26.73; or
6. Discrimination cases which, in themselves, do not warrant a
Severity Level III categorization.
Supplement VIII--Emergency Preparedness
This supplement provides examples of violations in each of the
four severity levels as guidance in determining the appropriate
severity level for violations in the area of emergency preparedness.
It should be noted that citations are not normally made for
violations involving emergency preparedness occurring during
emergency exercises. However, where exercises reveal (i) training,
procedural, or repetitive failures for which corrective actions have
not been taken, (ii) an overall concern regarding the licensee's
ability to implement its plan in a manner that adequately protects
public health and safety, or (iii) poor self critiques of the
licensee's exercises, enforcement action may be appropriate.
A. Severity Level I--Violations involving for example:
In a general emergency, licensee failure to promptly (1)
correctly classify the event, (2) make required notifications to
responsible Federal, State, and local agencies, or (3) respond to
the event (e.g., assess actual or potential offsite consequences,
activate emergency response facilities, and augment shift staff.)
B. Severity Level II--Violations involving for example:
1. In a site emergency, licensee failure to promptly (1)
correctly classify the event, (2) make required notifications to
responsible Federal, State, and local agencies, or (3) respond to
the event (e.g., assess actual or potential offsite consequences,
activate emergency response facilities, and augment shift staff); or
2. A licensee failure to meet or implement more than one
emergency planning standard involving assessment or notification.
C. Severity Level III--Violations involving for example:
1. In an alert, licensee failure to promptly (1) correctly
classify the event, (2) make required notifications to responsible
Federal, State, and local agencies, or (3) respond to the event
(e.g., assess actual or potential offsite consequences, activate
emergency response facilities, and augment shift staff); or
2. A licensee failure to meet or implement one emergency
planning standard involving assessment or notification.
D. Severity Level IV--Violations involving for example:
A licensee failure to meet or implement any emergency planning
standard or requirement not directly related to assessment and
notification.
Interim Enforcement Policies
Interim Enforcement Policy for Generally Licensed Devices Containing
Byproduct Material (10 CFR 31.5)
This section sets forth the interim enforcement policy that the NRC
will follow to exercise enforcement discretion for certain violations
of requirements in 10 CFR Part 31 for generally licensed devices
containing byproduct material. It addresses violations that persons
licensed pursuant to 10 CFR 31.5 identify and correct now, as well as
during the initial cycle of the notice and response program
contemplated by the proposed new requirements published in the Federal
Register on December 2, 1998 (63 FR 66492), entitled ``Requirements for
Those Who Possess Certain Industrial Devices Containing Byproduct
Material to Provide Requested Information''.
Exercise of Enforcement Discretion
Under this interim enforcement policy, enforcement action normally
will not be taken for violations of 10 CFR 31.5 if they are identified
by the general licensee, and reported to the NRC if reporting is
required, provided that the general licensee takes appropriate
corrective action to address the specific violations and prevent
recurrence of similar problems.
Exceptions
Enforcement action may be taken where there is: (a) failure to take
appropriate corrective action to prevent recurrence of similar
violations; (b) failure to respond and provide the information required
by the notice and response program (if it becomes a final rule); (c)
failure to provide complete and accurate information to the NRC; or (d)
[[Page 61166]]
a willful violation, such as willfully disposing of generally licensed
material in an unauthorized manner. Enforcement sanctions in these
cases may include civil penalties as well as Orders to modify or revoke
the authority to possess radioactive sources under the general license.
Interim Enforcement Policy Regarding Enforcement Discretion for Nuclear
Power Plants During the Year 2000 Transition
This section sets forth the interim enforcement policy that will
govern the exercise of enforcement discretion by the NRC staff when
licensees of operating nuclear power plants find it necessary to
deviate from license conditions, including technical specifications
(TSs), in those cases in which year 2000 (Y2K) related complications
would otherwise require a plant shutdown that could adversely affect
the stability and reliability of the electrical power grid. This policy
does not extend to situations in which a licensee may be unable to
communicate with the NRC.
The policy is effective August 30, 1999, and will remain in effect
through January 1, 2001. This policy only applies during Y2K transition
or rollover periods (December 31, 1999, through January 3, 2000;
February 28, 2000, through March 1, 2000; and December 30, 2000,
through January 1, 2001). During these periods, a licensee may contact
the NRC Headquarters Operations Center and seek NRC enforcement
discretion with regard to the potential noncompliance with license
conditions, including TSs, if the licensee has determined that:
(a) Complying with license conditions, including TSs, in a Y2K-
related situation would require a plant shutdown;
(b) Continued plant operation is needed to help maintain a reliable
and stable grid; and
(c) Any decrease in safety as a result of continued plant operation
is small (considering both risk and deterministic aspects), and
reasonable assurance of public health and safety, the environment, and
security is maintained with the enforcement discretion.
Licensees are expected to follow the existing guidance as stated in
NRC Inspection Manual Part 9900 for Notices of Enforcement Discretion
to the maximum extent practicable, particularly regarding a safety
determination and notification of NRC. A licensee seeking NRC
enforcement discretion must provide a written justification, or in
circumstances in which good cause is shown, an oral justification
followed as soon as possible by written justification. The
justification must document the need and safety basis for the request
and provide whatever other information the NRC staff needs to make a
decision regarding whether the exercise of discretion is appropriate.
The NRC staff may grant enforcement discretion on the basis of
balancing the public health and safety or common defense and security
of not operating against potential radiological or other hazards
associated with continued operation, and a determination that safety
will not be unacceptably affected by exercising the discretion. The
Director of the Office of Nuclear Reactor Regulation, or designee, will
advise the licensee whether the NRC has approved the licensee's request
and, if so, will subsequently confirm the exercise of discretion in
writing. Enforcement discretion will only be exercised if the NRC staff
is clearly satisfied that the action is consistent with protecting
public health and safety and is warranted in the circumstances
presented by the licensee.
If the volume of requests to the NRC Headquarters Operations Center
is such that the NRC staff cannot review and approve all licensee
requests in a timely fashion, the NRC staff will obtain the safety-
significant information from the licensee to enable the NRC staff to
make a prompt initial assessment. Unless the assessment is unfavorable,
the licensee would be permitted to proceed with its planned course of
action. The NRC staff will complete these assessments as time permits
and the licensee will be advised of the results orally, if possible,
and then in writing. If the NRC staff's prompt initial assessment or
subsequent assessment determines that a licensee's actions raise safety
concerns, the licensee would be so informed. The licensee would then be
required to follow its license conditions, including TSs.
If there are communications difficulties between the licensee and
the NRC, the licensee is encouraged to interact with the NRC inspector
onsite who will have a dedicated satellite telephone. The inspector
should be able to facilitate communication with the NRC Headquarters
Operations Center and/or the NRC Regional Incident Response Centers
(IRCs). If communication with the NRC Headquarters Operations Center is
not possible, then the licensee should contact the IRC in NRC Region IV
to discuss enforcement discretion. Similarly, if the Region IV IRC
cannot be reached, then the licensee should attempt to contact the
Region I, II and III IRCs. Although it is considered highly unlikely,
if communication with NRC is not possible, the licensee should follow
the plant license conditions, including technical specifications.
In conducting its assessments, the licensee should follow, to the
extent practicable, the guidance in NRC Inspection Manual Part 9900 for
Notices of Enforcement Discretion. Contrary to Part 9900 Section B.3
guidance, it is not necessary for an emergency to be declared by a
government entity. Licensees are encouraged to contact NRC early in
their evaluation process, particularly if time is of the essence, even
though complete information as specified in Part 9900 may not be
available.
The decision to exercise enforcement discretion does not change the
fact that the licensee will be in noncompliance nor does it imply that
enforcement discretion is being exercised for any noncompliance that
may have led to the noncompliance at issue. To the extent noncompliance
was involved, the NRC staff will normally take enforcement action for
the root causes that led to the noncompliance for which enforcement
discretion was granted. Enforcement action will also be considered in
those cases in which incorrect or incomplete information was provided
to the NRC staff by a licensee in its justification. The NRC recognizes
that a licensee will need to exercise judgment in making a
determination under this discretion provision. Consistent with the
NRC's position involving 10 CFR 50.54(x), enforcement action for a
violation of a license condition, including a TS, will not be taken
unless a licensee's action was clearly unreasonable considering all the
relevant circumstances. Enforcement action could include assessment of
civil penalties and the issuance of orders.
Interim Enforcement Policy for Use During the NRC Power Reactor
Oversight Process Pilot Plant Study
This section sets forth the interim enforcement policy that the NRC
will use to address violations of the requirements of 10 CFR Part 50
and associated license conditions at nine power reactor sites
participating in the NRC reactor oversight process pilot plant study
beginning in June 1999. This policy approaches enforcement for the
plants participating in the pilot plant study by dividing identified
violations into two groups.
I. Violations Evaluated by the Significance Determination Process
The first group consists of those violations that the Reactor
Oversight Program's Significance Determination Process (SDP) can
evaluate. For these
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violations, the SDP will determine the significance of the violation
and the Agency Action Matrix will determine the appropriate agency
response. These violations will be cited or non-cited. Normally, no
severity levels and civil penalties will be used to characterize these
violations.
A. Violations of Low Significance
Violations that the SDP evaluates as not being risk significant
(i.e., green) will be described in inspection reports as Non-Cited
Violation (NCVs) and be categorized by the assessment process within
the licensee response band. However, a Notice of Violation (NOV) will
be issued if:
(1) The licensee fails to restore compliance within a reasonable
time after they identified the violation;
(2) The licensee fails to place the violation into the corrective
action program; or
(3) The violation was willful. An NCV may be appropriate if the
violation meets the criteria in Section VII.B.1.a.4 of the Enforcement
Policy.
The three exceptions are consistent with items (1), (2), and (4) of
Section VII.B.1.a.
B. Significant Violations
Violations that the SDP evaluates as risk significant (i.e., white,
yellow, or red) will be assigned a color band related to its
significance for use by the assessment process. Because of being risk
significant, an NOV will be issued requiring a formal written response
unless sufficient information is already on the docket. The Commission
reserves the use of discretion for particularly significant violations
(e.g. an accidental criticality) to assess civil penalties in
accordance with Section 234 of the Atomic Energy Act of 1954, as
amended.
II. Violations Not Evaluated by the SDP and Those Having Actual
Consequences
In the second group of violations, the Enforcement Policy will be
retained, along with severity levels and the potential for the
imposition of civil penalties or other appropriate enforcement action.
Three categories of violations are within this group:
(A) Violations that involve willfulness including discrimination,
(B) Violations that may impact the NRC's ability for oversight of
licensee activities such as those associated with reporting issues,
failure to obtain NRC approvals such as for changes to the facility as
required by 10 CFR 50.59, 10 CFR 50.54(a), 10 CFR 50.54 (p), and
failure to provide the NRC with complete and accurate information or to
maintain accurate records, and
(C) Violations that involve actual consequences such as an
overexposure to the public or plant personnel, failure to make the
required notifications that impact the ability of federal, state and
local agencies to respond to an actual emergency preparedness or
transportation event, or a substantial release of radioactive material.
To the extent the above does not modify the NRC Enforcement Policy,
the NRC Enforcement Policy remains applicable to power reactor
licensees.
Dated at Rockville, Maryland, this 26th day of October, 1999.
For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 99-28595 Filed 11-8-99; 8:45 am]
BILLING CODE 7590-01-P