[Federal Register Volume 60, Number 126 (Friday, June 30, 1995)]
[Notices]
[Pages 34381-34403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15952]
Federal Register / Vol. 60, No. 126 / Friday, June 30, 1995 /
Notices
[[Page 34381]]
NUCLEAR REGULATORY COMMISSION
Revision of the NRC Enforcement Policy
AGENCY: Nuclear Regulatory Commission.
ACTION: Policy statement.
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SUMMARY: As a result of an assessment of the Nuclear Regulatory
Commission's (NRC) enforcement program, the NRC has revised its General
Statement of Policy and Procedure for Enforcement Actions (Enforcement
Policy or Policy). By a separate action published today in the Federal
Register, the Commission is removing the Enforcement Policy from the
Code of Federal Regulations.
DATES: This action is effective on June 30, 1995, while comments are
being received. Submit comments on or before August 14, 1995.
Additionally, the Commission intends to provide an opportunity for
public comments after this revised Enforcement Policy has been in
effect for about 18 months.
ADDRESSES: Send written comments to: The Secretary of the Commission,
U.S. Nuclear Regulatory Commission, Washington, DC 20555. ATTN:
Docketing and Service Branch. Hand deliver comments to: 11555 Rockville
Pike, Rockville, Maryland, between 7:45 am and 4:15 pm, Federal
workdays. Copies of comments received may be examined at the NRC Public
Document Room, 2120 L Street, NW. (Lower Level), Washington, DC.
FOR FURTHER INFORMATION CONTACT: James Lieberman, Director, Office of
Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555,
(301) 415-2741.
SUPPLEMENTARY INFORMATION: On May 13, 1994, the NRC's Executive
Director for Operations established a review team to assess the NRC
enforcement program. In its report (NUREG-1525,1 ``Assessment of
the NRC Enforcement Program,'' April 5, 1995), the review team
concluded that the existing NRC enforcement program, as implemented, is
appropriately directed toward supporting the agency's overall safety
mission. This conclusion is reflected in several aspects of the
program:
\1\ Copies of NUREG-1525 may be purchased from the
Superintendent of Documents, U.S. Government Printing Office, Mail
Stop SSOP, Washington, DC 20402-9328. Copies are also available from
the National Technical Information Service, 5285 Port Royal Road,
Springfield, Virginia 22161. A copy is also available for inspection
and copying for a fee in the NRC Public Document Room, 2120 L
Street, NW. (Lower Level), Washington, DC 20555-0001.
The Policy recognizes that violations have differing
degrees of safety significance. As reflected in the severity levels,
safety significance includes actual safety consequence, potential
safety consequence, and regulatory significance. The use of
graduated sanctions from Notices of Violation to orders further
reflects the varying seriousness of noncompliances.
The enforcement conference is an important step in
achieving a mutual understanding of facts and issues before making
significant enforcement decisions. Although these conferences take
time and effort for both the NRC and licensees, they generally
contribute to better decision-making.
Enforcement actions deliver regulatory messages
properly focused on safety. These messages emphasize the need for
licensees to identify and correct violations, to address the root
causes, and to be responsive to initial opportunities to identify
and prevent violations.
The use of discretion and judgment throughout the
deliberative process recognizes that enforcement of NRC requirements
does not lend itself to mechanistic treatment.
However, the Review Team found that the existing enforcement
program at times provided mixed regulatory messages to licensees, and
room for improvement existed in the Enforcement Policy. The review
suggested that the program's focus should be clarified to:
Emphasize the importance of identifying problems before
events occur, and of taking prompt, comprehensive corrective action
when problems are identified;
Direct agency attention at licensees with multiple
enforcement actions in a relatively short period; and
Focus on current performance of licensees.
In addition, the review team found that the process for assessing
civil penalties could be simplified to improve the predictability of
decision-making and obtain better consistency between regions.
As a result of its review, the review team made several
recommendations to revise the NRC Enforcement Policy to produce an
enforcement program with clearer regulatory focus and more
predictability. The Commission is issuing this policy statement after
considering those recommendations and the bases for them in NUREG-1525.
The more significant changes to the current Enforcement Policy are
described below:
I. Introduction and Purpose
This section has been modified to emphasize that the purpose and
objectives of the enforcement program are focused on using enforcement
actions:
(1) As a deterrent to emphasize the importance of compliance with
requirements; and
(2) To encourage prompt identification and prompt, comprehensive
correction of violations.
IV. Severity of Violations
Severity Level V violations have been eliminated. The examples at
that level have been withdrawn from the supplements. Formal enforcement
actions will now only be taken for violations categorized at Severity
Level I to IV to better focus the inspection and enforcement process on
safety. To the extent that minor violations are described in an
inspection report, they will be labeled as Non-Cited Violations (NCVs).
When a licensee does not take corrective action or repeatedly or
willfully commits a minor violation such that a formal response would
be needed, the violation should be categorized at least at a Severity
Level IV.
The NRC staff will be reviewing the severity level examples in the
supplements over the next 6 months. The purpose of this review is to
ensure the examples are appropriately focused on safety significance,
including consideration of actual safety consequence, potential safety
consequence, and regulatory significance.
V. Predecisional Enforcement Conferences
Enforcement conferences are being renamed ``predecisional
enforcement conferences.'' These conferences should be held for the
purpose of obtaining information to assist NRC in making enforcement
decisions when the agency reasonably expects that escalated enforcement
actions will result. They should also normally be held if requested by
a licensee. In addition they should normally be held before issuing an
order or a civil penalty to an unlicensed individual.
In light of the changes to the Enforcement Policy, the Commission
has decided to continue a trial program of conducting approximately 25
percent of eligible conferences open to public observation pending
further evaluation. (See 57 FR 30762; July 10, 1992, and 59 FR 36796;
July 19, 1994). The intent of open conferences is not to maximize
public attendance, but is rather for determining whether providing the
public with an opportunity to observe the regulatory process is
compatible with the NRC's ability to exercise its regulatory and safety
responsibilities. The provisions of the trial program have been
incorporated into the Enforcement Policy.
[[Page 34382]]
VI. Enforcement Actions
A. Notice of Violation
This section was modified to clarify that the NRC may waive all or
portions of a licensee's written response to a Notice of Violation to
the extent relevant information has already been provided to the NRC in
writing or documented in an NRC inspection report and is on the
applicable docket in the NRC Public Document Room.
B. Civil Penalty
1. Base Civil Penalty
Tables 1A and 1B have been revised. In Table 1B the percentage for
Severity Level IV violations has been deleted since such violations
will not be subject to civil penalties. If a violation that would
otherwise be categorized at a Severity Level IV violation merits a
civil penalty because of its significance, the violation would normally
be categorized at a Severity Level III.
Table 1A has been simplified to combine categories of licensees
with the same base penalty amounts. The base penalty amounts have
generally remained unchanged. The revised policy notes that the base
penalties may be adjusted on a case-by-case basis to reflect the
ability to pay and the gravity of the violation. 10 CFR Part 35
licensees (doctors, nuclear pharmacies, and other medical related
licensees) are combined into an overall medical category, based on the
similarity of hazards. Because transportation violations for all
licensees are primarily concerned with the potential for personnel
exposure to radiation, the violations in this area will be treated the
same as those in the health physics area.
The $100,000 base civil penalty amount for safeguards violations,
which applies to only two categories of licensees, fuel fabricators and
independent fuel and monitored retrievable storage installations, has
been deleted. The penalty amount for safeguards should be the same as
for other violations at these facilities. NRC has not had significant
safeguards violations at these facilities. If the penalty that would
normally be assessed for operational violations is not adequate to
address the circumstances of the violation, then discretion would be
used to determine the appropriate penalty amount.
The base civil penalty for ``other'' materials licensees, currently
set at $1000, has been increased to $5000. The primary concerns for
these licensed activities are individual radiation exposure and loss of
control of material to the environment, both of which warrant a more
financially meaningful penalty. A $500 civil penalty for a Severity
Level III violation (at 50% of the Severity Level I base amount) does
not reflect the seriousness of this type of violation for this category
of licensee. It is noted that with the revised assessment approach,
these licensees will not normally receive a civil penalty if prompt and
comprehensive corrective action is taken for isolated non-willful
Severity Level III violations.
2. Civil Penalty Assessment
This section has been renamed to reflect that the process for
assessing civil penalties has been substantially changed. The revised
process is intended to:
Continue to emphasize compliance in a manner that deters
future violations;
Encourage prompt identification and prompt, comprehensive
correction of violations and their root causes;
Apply the recognition of good past performance to give
credit to a licensee committing a non-willful SL III violation who has
had no previous significant violations during the past 2 years or 2
inspections (whichever is longer);
Place greater attention on situations of greater concern
(i.e., where a licensee has had more than one significant violation in
a 2-year or two-inspection period, where corrective action is less than
prompt and comprehensive, or where egregious circumstances, such as
where it is clear that repetitiveness or willfulness, are involved);
Streamline the NRC decisional process in a manner that
will preserve judgment and discretion, but will provide a clear
normative standard and produce relatively predictable results for
routine cases; and
Provide clear guidance on applying fewer adjustment
factors in various types of cases, in order to increase consistency and
predictability.
Once a violation has been categorized at a Severity Level III or
above, the assessment process considers four basic decisional points:
(1) Whether the licensee has had a previous escalated enforcement
action during the past 2 years or past 2 inspections, whichever is
longer;
(2) Whether the licensee should be given credit for actions related
to identification;
(3) Whether the licensee's corrective actions may reasonably be
considered prompt and comprehensive; and
(4) Whether, in view of all the circumstances, the case in question
warrants the exercise of discretion. As described in the Enforcement
Policy, each of these decisional points may have several associated
considerations for any given case. However, the outcome of a case,
absent the exercise of discretion, is limited to three results: no
civil penalty, a base civil penalty, or a base civil penalty escalated
by 100%.
D. Related Administrative Actions
The reference to related administrative mechanisms have been
replaced with related administrative actions to clarify the documents
as actions.
VII. Exercise of Discretion
The ability to exercise discretion is preserved with the revised
policy. Discretion is provided to deviate from the normal approach to
either increase or decrease sanctions where necessary to ensure that
the sanction reflects the significance of the circumstances and conveys
the appropriate regulatory message. This section has been modified to
provide examples where it is appropriate to consider civil penalties or
escalate civil penalties notwithstanding the normal assessment process
in Section VI of the Enforcement Policy. One significant example to
note involves the loss of a source. This example is being added to
emphasize the importance of licensees being aware of the location of
their sources and to recognize that there should not be an economic
advantage for inappropriate disposal or transfer. As to mitigation of
sanctions for violations involving special circumstances, mitigation
can be considered if the licensee has demonstrated overall sustained
performance which has been particularly good. The levels of approval
for exercising discretion are described in this section. Finally, Table
2, ``Examples of Progressions of Escalated Enforcement Actions for
Similar Violations in the Same Activity Area Under the Same License,''
has been withdrawn from the Enforcement Policy. The guidance in that
table is not needed because the policy is clear that each case should
be judged on its own merits, especially those repetitive violation
cases to which the table applied.
VIII. Enforcement Actions Involving Individuals
The Enforcement Policy has been clarified to provide that some
action is normally to be taken against a licensee for violations caused
by significant acts of wrongdoing by its employees, contractors, or
contractors employees. The Policy has also been modified to state that
the nine factors in Section VIII
[[Page 34383]]
should be used to assist in the decision on whether enforcement action
should be taken against an unlicensed individual as well as the
licensee. The Policy currently uses these factors to determine whether
to take enforcement action against an unlicensed person rather than the
licensee. These changes are consistent with the intent of the
Commission in promulgating the rule on deliberate misconduct (56 FR
40664, 40666, August 15, 1991). Less significant cases may be treated
as an NCV under Section VII.B.1. A Letter of Reprimand is not a
sanction and is now referred to as an administrative action consistent
with Section VI.D of the Policy.
The Commission expects that the changes to the Enforcement Policy
should result in an increase in the protection of the public health and
safety by better emphasizing the prevention, detection, and correction
of violations before events occur with impact on the public. In about 2
years the Commission intends to review the Enforcement Policy. In that
regard, it is expected that in about 18 months an opportunity will be
provided to receive public comments on the implementation of this
Policy.
General Statement of Policy and Procedure for NRC Enforcement
Actions
Table of Contents
Preface
I. Introduction and Purpose
II. Statutory Authority
A. Statutory Authority
B. Procedural Framework
III. Responsibilities
IV. Severity of Violations
A. Aggregation of Violations
B. Repetitive Violations
C. Willful Violations
D. Violations of Reporting Requirements
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. Licensee-Identified Severity Level IV Violations
2. Violations Identified During Extended Shutdowns or Work
Stoppages
3. Violations Involving Old Design Issues
4. Violations Identified Due to Previous Escalated Enforcement
Action
5. Violations Involving Discrimination
6. Violations Involving Special Circumstances
C. Exercise of Discretion for an Operating Facility
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
Preface
The following statement of general policy and procedure explains
the enforcement policy and procedures of the U.S. Nuclear Regulatory
Commission (NRC or Commission) and the NRC staff (staff) in initiating
enforcement actions, and of the presiding officers and the Commission
in reviewing these actions. This statement is applicable to enforcement
in matters involving the radiological health and safety of the public,
including employees' health and safety, the common defense and
security, and the environment.1 This statement of general policy
and procedure will be published as NUREG-1600 to provide widespread
dissemination of the Commission's Enforcement Policy. However, this is
a policy statement and not a regulation. The Commission may deviate
from this statement of policy and procedure as appropriate under the
circumstances of a particular case.
\1\ Antitrust enforcement matters will be dealt with on a case-
by-case basis.
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I. Introduction and Purpose
The purpose of the NRC enforcement program is to support the NRC's
overall safety mission in protecting the public and the environment.
Consistent with that purpose, enforcement action should be used:
As a deterrent to emphasize the importance of compliance
with requirements, and
To encourage prompt identification and prompt,
comprehensive correction of violations.
Consistent with the purpose of this program, prompt and vigorous
enforcement action will be taken when dealing with licensees,
vendors,2 contractors, and their employees, who do not achieve the
necessary meticulous attention to detail and the high standard of
compliance which the NRC expects.3 Each enforcement action is
dependent on the circumstances of the case and requires the exercise of
discretion after consideration of these policies and procedures. In no
case, however, will licensees who cannot achieve and maintain adequate
levels of protection be permitted to conduct licensed activities.
\2\ The term ``vendor'' as used in this policy means a supplier
of products or services to be used in an NRC-licensed facility or
activity.
\3\ This policy primarily addresses the activities of NRC
licensees and applicants for NRC licenses. Therefore, the term
``licensee'' is used throughout the policy. However, in those cases
where the NRC determines that it is appropriate to take enforcement
action against a non-licensee or individual, the guidance in this
policy will be used, as applicable. Specific guidance regarding
enforcement action against individuals and non-licensees is
addressed in Sections VIII and X, respectively.
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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.
Chapter 18 of the Atomic Energy Act provides for varying levels of
criminal
[[Page 34384]]
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
Nuclear Material Safety, Safeguards and Operations Support (DEDS) and
the Deputy Executive Director for Nuclear Reactor Regulation, Regional
Operations, and Research (DEDR), have been delegated the authority to
approve or issue all escalated enforcement actions.4 The DEDS is
responsible to the EDO for the NRC enforcement programs. The Office of
Enforcement (OE) exercises oversight of and implements the NRC
enforcement programs. The Director, OE, acts for the Deputy Executive
Directors in enforcement matters in their absence or as delegated.
\4\ 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 appropriate 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 a Deputy Executive Director
or the Director, OE. 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
Director, Office of the Controller, 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 technical
significance of the violations and the surrounding circumstances.
Unless Commission consultation or notification is required by this
policy, the staff may depart, where warranted in the public's interest,
from this policy as provided in Section VII,''Exercise of Enforcement
Discretion.'' The Commission will be provided written notification of
all enforcement actions involving civil penalties or orders. The
Commission will also be provided notice in those cases where discretion
is exercised as discussed in Section VII.B.6. In addition, 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 with the potential radiological or other
hazards associated with continued operation;
(2) Proposals to impose civil penalties in amounts greater than 3
times the Severity Level I values shown in Table 1A;
(3) Any proposed enforcement action that involves a Severity Level
I violation;
(4) Any enforcement action that involves a finding of a material
false statement;
(5) Exercising discretion for matters meeting the criteria of
Section VII.A.1 for Commission consultation;
(6) Refraining from taking enforcement action for matters meeting
the criteria of Section VII.B.2;
(7) Any proposed enforcement action that involves the issuance of a
civil penalty or order to an unlicensed individual or a civil penalty
to a licensed reactor operator;
(8) Any action the EDO believes warrants Commission involvement;
(9) Any proposed enforcement case involving an Office of
Investigation (OI) report where the 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
(10) Any proposed enforcement action on which the Commission asks
to be consulted.
[[Page 34385]]
IV. Severity of Violations
Regulatory requirements 5 have varying degrees of safety,
safeguards, or environmental significance. Therefore, the relative
importance of each violation, including both the technical significance
and the regulatory significance is evaluated as the first step in the
enforcement process.
\5\ The term ``requirement'' as used in this policy means a
legally binding requirement such as a statute, regulation, license
condition, technical specification, or order.
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Consequently, for purposes of formal enforcement action, violations
are normally categorized in terms of four levels of severity to show
their relative importance 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. In
general, violations that are included in these severity categories
involve actual or high potential impact on the public. Severity Level
III violations are cause for significant regulatory concern. Severity
Level IV violations are less serious but are of more than minor
concern; i.e., if left uncorrected, they could lead to a more serious
concern.
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 are noted as Non-Cited Violations.6
\6\ A Non-Cited Violation (NCV) is a violation that has not been
formalized into a 10 CFR 2.201 Notice of Violation.
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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. In some cases, special circumstances may warrant
an adjustment to the severity level categorization.
A. Aggregation of Violations
A group of Severity Level IV violations may be evaluated in the
aggregate and assigned a single, increased severity level, thereby
resulting in a Severity Level III problem, if the violations have the
same underlying cause or programmatic deficiencies, or the violations
contributed to or were unavoidable consequences of the underlying
problem. Normally, Severity Level II and III violations are not
aggregated into a higher severity level.
The purpose of aggregating violations is to focus the licensee's
attention on the fundamental underlying causes for which enforcement
action appears warranted and to reflect the fact that several
violations with a common cause may be more significant collectively
than individually and may therefore, warrant a more substantial
enforcement action.
B. Repetitive Violations
The severity level of a Severity Level IV violation may be
increased to Severity Level III, if the violation can be considered a
repetitive violation.7 The purpose of escalating the severity
level of a repetitive violation is to acknowledge the added
significance of the situation based on the licensee's failure to
implement effective corrective action for the previous violation. The
decision to escalate the severity level of a repetitive violation will
depend on the circumstances, such as, but not limited to, the number of
times the violation has occurred, the similarity of the violations and
their root causes, the adequacy of previous corrective actions, the
period of time between the violations, and the significance of the
violations.
\7\ The term ``repetitive violation'' or ``similar violation''
as used in this policy statement means a violation that reasonably
could have been prevented by a licensee's corrective action for a
previous violation normally occurring (1) within the past 2 years of
the inspection at issue, or (2) the period within the last two
inspections, whichever is longer.
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C. 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. 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. Although removal of the person is not
necessarily required, substantial disciplinary action is expected.
Therefore, the severity level of a violation may be increased if
the circumstances surrounding the matter involve careless disregard of
requirements, deception, or other 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., inadvertent clerical errors in a document submitted to the NRC.
In determining the specific severity level 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 8 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
[[Page 34386]]
factors in arriving at the appropriate severity level 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 categorized at least at a
Severity Level IV.
\8\ 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.
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D. Violations of Reporting Requirements
The NRC expects licensees to provide complete, accurate, and timely
information and reports. Accordingly, unless otherwise categorized in
the Supplements, 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
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.
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 vendor, the NRC
may provide an opportunity for a predecisional enforcement conference
with the licensee, vendor, 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 action 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
unless the licensee requests it. 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 will
normally 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 action.
During the predecisional enforcement conference, the licensee,
vendor, or other persons will be given an 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, vendors, 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 not normally open to public observation. However, a trial
program is being conducted to open approximately 25 percent of all
eligible conferences for public observation, i.e., every fourth
eligible conference involving one of three categories of licensees
(reactor, hospital, and other materials licensees) will be open to the
public. 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; 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 intervenors 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,
with the approval of the Executive Director for Operations, conferences
will not be open to the public where good cause has been shown after
balancing the benefit of the public observation against the potential
impact on the agency's enforcement action in a particular case.
As soon as it is determined that a conference will be open to
public observation, the NRC will notify the licensee that the
conference will be open to public observation as part of the agency's
trial program. Consistent with the agency's policy on open meetings,
``Staff Meetings Open to Public,'' published September 20, 1994 (59 FR
48340), the NRC intends to announce open conferences normally at least
10 working days in advance of conferences through (1) notices posted in
the Public Document Room, (2) a toll-free telephone recording at 800-
952-9674, and (3) a toll-free electronic bulletin board at 800-952-
9676. In addition, the NRC will also 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 under the trial program may
observe but not participate in the conference. It is noted that the
purpose of conducting open conferences under the trial program is not
to maximize public attendance, but rather to determine whether
providing the public with opportunities to be informed of NRC
activities is compatible 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.
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.
[[Page 34387]]
Persons attending open conferences will be provided an opportunity to
submit written comments concerning the trial program anonymously to the
regional office. These comments will be subsequently forwarded to the
Director of the Office of Enforcement for review and consideration.
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.
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. For the vast majority of violations, a Notice of
Violation or a Notice of Nonconformance is the normal action.
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. However,
special circumstances regarding the violation findings may warrant
discretion being exercised such that the NRC refrains from issuing a
Notice of Violation. (See Section VII.B, ``Mitigation of Enforcement
Sanctions.'') In addition, licensees are not ordinarily cited for
violations resulting from matters not within their 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.
Accordingly, this policy should not be construed to excuse personnel
errors.
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 violations of significant regulatory
concern.
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, vendors,
and other persons. Tables 1A and 1B show the base civil penalties for
various reactor, fuel cycle, materials, and vendor 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.
2. Civil Penalty Assessment
In an effort to (1) emphasize the importance of adherence to
requirements and (2) reinforce prompt 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.
[[Page 34388]]
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
[[Page 34389]]
[GRAPHIC][TIFF OMITTED]TN30JN95.052
BILLING CODE 7590-01-P
[[Page 34390]]
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; 9
\9\ 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 had 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;
(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-
[[Page 34391]]
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 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
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
[[Page 34392]]
environment for raising safety concerns in the workplace, and (2)
provides a remedy for the particular discrimination at issue.
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 the NRC's concern regarding the violation at issue and
that it conveys the appropriate message to the licensee. However, in no
instance will a civil penalty for any one violation exceed $100,000 per
day.
Table 1A.--Base Civil Penalties
------------------------------------------------------------------------
------------------------------------------------------------------------
a. Power reactors.......................................... $100,000
b. Fuel fabricators, industrial processors, and independent
spent fuel and monitored retrievable storage installations 25,000
c. Test reactors, mills and uranium conversion facilities,
contractors, vendors, waste disposal licensees, and
industrial radiographers.................................. 10,000
d. Research reactors, academic, medical, or other material
licensee \1\.............................................. 5,000
------------------------------------------------------------------------
\1\ 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
------------------------------------------------------------------------
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 unlicensed persons, including vendors and contractors,
and employees of any of them, 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
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 vendors 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
vendor's 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 vendor'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.
[[Page 34393]]
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 appropriately reflects the level of
NRC concern regarding the violation at issue and conveys the
appropriate message to the licensee.
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 appropriate 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
$100,000 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 and conveys the
appropriate regulatory message to the licensee. Consultation with the
Commission is required 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 excessive duration of a problem has
resulted in a substantial increase in risk;
(f) Situations when the licensee made a conscious decision to be in
noncompliance in order to obtain an economic benefit; or
(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.
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. In order to recognize the added technical
safety significance or regulatory 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 $100,000 for each day the violation continues. The
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, if the outcome of the normal
process described in Section VI.B does not result in a sanction
consistent with an appropriate regulatory message. In addition, even if
the NRC exercises this discretion, when the licensee failed to make a
required report to the NRC, a separate enforcement action will normally
be issued for the licensee's failure to make a required report. The
approval of the Director, Office of Enforcement, with consultation with
the appropriate Deputy Executive Director as warranted, is required for
exercising discretion of the type described in Section VII.B.1.b where
a willful violation is involved, and of the types described in Sections
VII.B.2 through VII.B.5. Commission consultation is required for
exercising discretion of the type described in Section VII.B.2 and the
approval of the appropriate Deputy Executive Director and Commission
notification is required for exercising the discretion of the type
described in Section VII.B.6. Examples when discretion should be
considered for departing from the normal approach in Section VI.B
include but are not limited to the following:
1. Licensee-Identified Severity Level IV Violations. The NRC, with
the approval of the Regional Administrator or his designee, may refrain
from issuing a Notice of Violation 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 a Non-Cited Violation
(NCV) provided that the inspection report includes a brief description
of the corrective action and that the violation meets all of the
following criteria:
(a) It was identified by the licensee, including identification
through an event;
(b) 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;
(c) 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;
(d) 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.C);
(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.
Although removal of the employee from licensed activities is not
necessarily required, substantial disciplinary action is expected.
2. Violations Identified During Extended Shutdowns or Work
[[Page 34394]]
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 a severity level higher than
Severity Level II;
(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 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 cases that meet 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.
4. Violations Identified Due to Previous Escalated 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 escalated enforcement action for a Severity Level II or III
violation, 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 escalated enforcement action;
(b) It has the same or similar root cause as the violation for
which escalated 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.
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 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 civil penalty assessment process addressed in
Section VI.B, as provided in Section III, ``Responsibilities,'' the NRC
may reduce or refrain from issuing a civil penalty or a Notice of
Violation for a Severity Level II or III 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 safety significance
of the violation, 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.
C. Exercise of Discretion for an Operating Facility
On occasion, circumstances may arise where a licensee's compliance
with a Technical Specification (TS) Limiting Condition for Operation or
with other license conditions would involve an
[[Page 34395]]
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. In these circumstances, the
NRC staff may choose not to enforce the applicable TS or other license
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. A licensee 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 or not 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 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). The person
exercising enforcement discretion will document the decision.
For an operating plant, 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.
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 should not
rely on the NRC's authority to exercise enforcement discretion as a
routine substitute for compliance or for requesting a license
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 advice 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.
[[Page 34396]]
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 vendors 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 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 appropriate Deputy Executive
Director. The particular sanction to be used should be determined on a
case-by-case basis.10 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.
\10\ 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
[[Page 34397]]
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, ``Severity 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.
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 employees of licensees, to contractors and
subcontractors, and to employees of contractors and subcontractors, 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 submission of incomplete or inaccurate
information are provided in the rule on deliberate misconduct, e.g., 10
CFR 30.10 and 50.5.
Vendors of 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 reactor licensees, vendors
may be required to have quality assurance programs that meet applicable
requirements including 10 CFR Part 50, Appendix B, and 10 CFR Part 71,
Subpart H. Vendors supplying products or services to reactor,
materials, and 10 CFR Part 71 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 vendors 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 vendors have programs that meet applicable requirements.
Notices of Violation will be issued for vendors that violate 10 CFR
Part 21. Civil penalties will be imposed against individual directors
or responsible officers of a vendor organization who knowingly and
consciously fail to provide the notice required by 10 CFR 21.21(b)(1).
Notices
[[Page 34398]]
of Nonconformance will be used for vendors which fail to meet
commitments related to NRC activities.
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 appropriate Deputy Executive
Director.
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 11 designed to prevent or mitigate a serious
safety event not being able to perform its intended safety function
12 when actually called upon to work;
\11\ The term ``system'' as used in these supplements, includes
administrative and managerial control systems, as well as physical
systems.
\12\ ``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:
(a) 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); or
(b) Being degraded to the extent that a detailed evaluation would
be required to determine its operability (e.g., component parameters
outside approved limits such as pump flow rates, heat exchanger
transfer characteristics, safety valve lift setpoints, or valve stroke
times);
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 significant failure to meet the requirements of 10 CFR 50.59,
including a failure such that a required license amendment was not
sought;
6. A licensee failure to conduct adequate oversight of vendors
resulting in the use of products or services that are of defective or
indeterminate quality and that have safety significance;
7. A breakdown in the control of licensed activities involving 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; or
8. A licensed operator's confirmed positive test for drugs or
alcohol that does not result in a Severity Level I or II violation.
9. Equipment failures caused by inadequate or improper maintenance
that substantially complicates recovery from a plant transient.
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 failure to meet the requirements of 10 CFR 50.59 that does not
result in a Severity Level I, II, or III violation;
3. A failure to meet regulatory requirements that have more than
minor safety or environmental significance; or
4. A failure to make a required Licensee Event Report.
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 13 in such a manner that they
[[Page 34399]]
would not have satisfied their intended safety related purpose.
\13\ 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, 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 14 of
special nuclear material (SNM); or
\14\ 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 15 who represents a
threat into a vital area 16 from outside the protected area;
\15\ 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.
\16\ 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 17 in which the security system did not function as
required; or
\17\ 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 18 into a vital area from outside the protected
area;
\18\ 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;
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; or
8. A breakdown in the security program involving a number of
violations that are related (or, if isolated, that are recurring
violations) that collectively reflect a potentially significant lack of
attention or carelessness toward licensed responsibilities.
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 make, maintain, or provide log entries in
accordance with 10 CFR 73.71 (c) and (d), where the omitted information
(i) is not otherwise available in easily retrievable records, and (ii)
significantly contributes to the ability of either the NRC or the
licensee to identify a programmatic breakdown;
5. A failure to conduct a proper search at the access control
point;
6. 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;
7. 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;
8. A failure to conduct an adequate search at the exit from a
material access area;
[[Page 34400]]
9. 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
10. 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
20.19
\19\ 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
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. A worker exposure above regulatory limits when such exposure
reflects a programmatic (rather than an isolated) weakness in the
radiation control program;
5. 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));
6. 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));
7. 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);
8. 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;
9. Disposal of licensed material not covered in Severity Levels I
or II;
10. 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, or that reflects a programmatic (rather than an
isolated) weakness in the radiation control program;
11. Conduct of licensee activities by a technically unqualified
person;
12. A significant failure to control licensed material; or
13. A breakdown in the radiation safety program involving a number
of violations that are related (or, if isolated, that are recurring)
that collectively represent a potentially significant lack of attention
or carelessness toward licensed responsibilities.
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; or
8. 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
[[Page 34401]]
in the area of NRC transportation requirements 20.
\20\ Some transportation requirements are applied to more than
one licensee involved in the same activity such as a shipper and a
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;
4. A failure to make required initial notification associated with
Severity Level III violations; or
5. A breakdown in the licensee's program for the transportation of
licensed material involving a number of violations that are related
(or, if isolated, that are recurring violations) that collectively
reflect a potentially significant lack of attention or carelessness
toward licensed responsibilities.
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; or
4. A failure to follow the procedures of the quality management
program, required by Section 35.32, that results in a death or serious
injury (e.g., substantial organ impairment) to a patient.
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; or
3. A substantial programmatic failure in the implementation of the
quality management program required by 10 CFR 35.32 that results in a
misadministration.
C. Severity Level III--Violations involving for example:
1. A failure to control access to licensed materials for radiation
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
person;
5. Radiation levels, contamination levels, or releases that exceed
the limits specified in the license;
6. Substantial failure to implement the quality management program
as required by Section 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 breakdown in the control of licensed activities involving 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;
8. A failure, during radiographic operations, to have present or to
use radiographic equipment, radiation survey instruments, and/or
personnel monitoring devices as required by 10 CFR Part 34;
9. A failure to submit an NRC Form 241 in accordance with the
requirements in Section 150.20 of 10 CFR Part 150;
10. 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 safety guidelines; or a change in the quantity or type of
radioactive material being processed or used that has radiological
significance; or
11. 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
[[Page 34402]]
accordance with regulation or license condition, or failure to meet
required schedules without adequate justification.
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; or
3. Failure to follow the quality management 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
Section 35.32; or
4. A failure to keep the records required by Sections 35.32 or
35.33.
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 21 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.
\21\ 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.22
\22\ 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 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 above first-line supervision 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 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 or vendors
have an effective fitness-for-duty program;
9. A breakdown in the fitness-for-duty program involving a number
of violations of the basic elements of the fitness-for-duty program
that collectively reflect a significant lack of attention or
carelessness towards
[[Page 34403]]
meeting the objectives of 10 CFR 26.10; or
10. 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 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);
2. A licensee failure to meet or implement more than one emergency
planning standard involving assessment or notification; or
3. A breakdown in the control of licensed activities involving 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.
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.
Dated at Rockville, Maryland, this 23rd day of June 1995.
For the Nuclear Regulatory Commission.
John C. Hoyle,
Secretary of the Commission.
[FR Doc. 95-15952 Filed 6-29-95; 8:45 am]
BILLING CODE 7590-01-P
