ML20249C414
| ML20249C414 | |
| Person / Time | |
|---|---|
| Issue date: | 05/11/1998 |
| From: | Rathbun D NRC OFFICE OF CONGRESSIONAL AFFAIRS (OCA) |
| To: | Inhofe J, Schaefer D HOUSE OF REP., ENERGY & COMMERCE, HOUSE OF REP., ENVIRONMENT & PUBLIC WORKS |
| Shared Package | |
| ML20249C412 | List: |
| References | |
| CCS, NUDOCS 9806290261 | |
| Download: ML20249C414 (4) | |
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j pmcarp p h UNIT,ED STATES g j NUCLEAR REGULATORY COMMISSION p $ WASHINGTON. D.C. seseHoot Y+9 ***** ,d May 11, 1998
' The Honorable Dan Schaefer Chairman, Subcommittee on Energy and Power Committee on Commerce United States House of Representatives
-Washington, DC 20515 L
r
Dear Mr. Chairman:
l l Enclosed for the information of the Subcommittee is a copy of a revised version of the NRC's
- General Statement of Policy and Procedure for Enforcement Actions (Enforcement Policy). This l
document will be published in the Federal Register.
This revision makes adjustments to the Policy approved by the Commission based on a review of our experience in the two years since the previous major revision. The changes in this revision address the meaning of safety and compliance as used in the policy statement, reflect l organizational changes, modify the procedures for documenting minor violations and for l conducting predecisional enforcement conferences, make adjustments to civil penalty amounts, l and address mitigation of enforcement sanctions. This revision also incorporates the changes to the Policy that were previously published in the Federal Register since July 1995.
Sincerely, I
D Mk( D l
- F Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Enforcement Policy Revision Notice !
l cc w/ enclosure:
Representative Ralph Hall l
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- p UNITED STATES
- ! j NUCLEAR REGU'LATORY COMMISSION
$ t WASHINGTON, D.C. 20666-0001
%*****/ May 11, 1998 The Honorable James M. Inhofe Chairman, Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety Committee on Environment and Public Works United States Senate Washington, DC 20510
Dear Mr. Chairman:
l Enclosed for the information of the Subcommittee is a copy of a revised version of the NRC's General Statement of Policy and Procedure for Enforcement Actions (Enforcement Policy). This document will be published in the Federal Reaister.
This revision makes adjustments to the Policy approved by the Commission based on a review of our experience in the two years since the previous major revision. The changes in this revision address the meaning of safety and compliance as used in the policy statement, reflect organizational changes, modify the procedures for documenting minor violations, and for conducting predecisional enforcement conferences, make adjustments to civil penalty amounts, and address mitigation of enforcement sanctions. This revision also incorporates the changes to the Policy that were previously published in the Federal Register since July 1995.
Sincerely, L' L U-L Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Enforcement Policy Revision Notice cc w/ enclosure:
Senator Bob Graham i
1
May 11, 1998 -
The Honorable Dan Schaefer Chairman, Subcommittee on Energy and Power Committee on Commerce
. United States House of Representatives Washington, DC 20515
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee is a copy of a revised version of the NRC's General Statement of Policy and Procedure for Enforcement Actions (Enforcement Policy). This document will be published in the Federal Reaister.
This revision makes adjustments to the Policy approved by the Commission based on a review l of our experience in the two years since the previous major revision. The changes in this revision address the meaning of safety and compliance as used in the policy statement, reflect organizational changes, modify the procedures for documenting minor violations and for conducting predecisional enforcement conferences, make adjustments to civil penalty amounts, and address mitigation of enforcement sanctions. This revision also incorporates the changes to the Policy that were previously published in the Federal Register since July 1995.
Sincerely,-
l Dennie K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Enforcement Policy Revision Notice distribution:
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NUCLEAR REGULATORY COMMISSION 1
1 (NUREG-1600, Rev.1) l NRC Enforcement Policy AGENCY: Nuclear Regulatory Commission.
ACTION: Policy Statement: revision.
SUMMARY
- The Nuclear Regulatoiy Commission (NRC) is publishing a complete revision of the agency's Enforcement Policy (NUREG-1600, " General Statement of Policy and Procedure for NRC Enforcement Actions") based on (1) a 2-year review of the revised Enforcement Policy, that was effective June 30,1995, and (2) a consolidation of changes to the Enforcement Policy since June 30,1995.
DATES: This action is effective [date of publication in the Federal Register), while comments are being received. Submit comments on or before (45 days after publication in the Federal Register).
ADDRESSES: Submit written comments to: David L. Meyer, Chief, Rules and Directives Branch, Division of Administrative Services, Office of Administration, Mail Stop:
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cfcedid9! Sopp ]
- k. s T6D59, U. S. Nuclear Regulatory Commission, Washington, DC 20555. Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland, between 7:30 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 June 30,1995, the Commission published a complete revision of the NRC's Enforcement Policy (60 FR 34381). The changes to the Enforcement Policy resulted from the efforts of a review team established in 1994 to assess the NRC's enforcement program. The review team published its recommendations in NUREG-1525, " Assessment of the NRC Enforcement Program," and the Commission made revisions to the Enforcement Policy after considering those recommendations. The revisions to the Enforcement Policy were intended to, among other things:
e Emphasize the importance of identifying problems before events occur, and of taking prompt, comprehensive corrective action when problems are identified; e Direct agency attention at licensees with multiple enforcement actions in a relatively short period; and a Focus on current performance of licensees.
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The revisions to the Enforcement Policy were also intended to better focus the l
inspection and enforcement process on safety, provide greater incentives for strong self-monitoring and corrective action programs in the civil penalty assessment process, provide more predictability and consistency in the civil penalty assessment process, and to better convey clear regulatory messages. '
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l When the Commission published the revised Enforcement Policy in the Federal I
Register on June 30,1995, it stated that it would provide the public an opportunity to comment on the revised Enforcement Policy after it had been in effect for about 18 months.
l On February 5,1997 (62 FR 5495), the Commission published an opportunity for the public l to comment on the revised Enforcement Policy.
The NRC has reviewed approximately 2 years of experience under the revised-Enforcement Policy and considered public comments. The NRC staff prepared a report (NUREG-1622, "NRC Enforcement Policy Review: July 1995 - July 1997," November
' 1997) that concluded that the changes made to the Enforcement Policy in 1995 (especially in the civil penalty assessment process) have helped to improve the predictability and consistency of enforcement actions, while maintaining the agency's desire to use enforcement sanctions for 8
Copies of NUREG-1622 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 report is also included on the NRC's Office of Enforcement's homepage on the Internet at www.nrc. gov /OE/.
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f f providing appropriate emphasis and deterrence in a way that helps to suppon the agency's overall safety mission. This conclusion is reflected in several aspects of the Enforcement Policy:
e The current Enforcement Policy is appropriately geared toward creating deterrence (i.e., taking action in a manner that provides incentives to identify and correct violations that have occurred and discourage future violations) and is properly structured for nuclear regulation.
e The Enforcement Policy recognizes that violations have varying degrees of safety significance, and that in considering the significance of a violation, it is appropriate to consider the technical significance (i.e., actual and potential consequences) and the regulatory significance. In addition, risk is an appropriate consideration in evaluating the technical significance of a violation.
e The Enforcement Policy is appropriately structured to maintain a focus on safety.
e The current civil penalty assessment process is appropriately structured to reflect issues the agency believes are appropriate to consider in assessing whether a civil
. penalty should be proposed, i.e., past performance, identification, corrective action, and those warranting discretion.
e The use of discretion and judgment throughout the deliberative process recognizes that enforcement of NRC requirements does not lend itself to mechanistic treatment.
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3 s Notwithstariding the general satisfaction with the Enforcement Policy, the review included a number of recommendations to the Commission for revisions to the Enforcement Policy and for development of additional enforcement guidance. The Commission is issuing this policy statement after considering those recommendations and the bases for them in NUREG-1622.
The more significant changes to the Enforcement Policy (in the order that they appear in the Policy) are described below:
I. Introduction and Purpose This section has been modified to include a brief discussion on the meaning of " safety" and " compliance" as they are used in the context of this policy statement. This section also i
references a new appendix (Appendix A) that describes the nexus between safety and l compliance.
III. Responsibilities This section has been modified to reflect that the Chief Financial Officer (CFO) is
- delegated the authority to issue orders where licensees violate Commission regulations by nonpayment of license and inspection fees. The Office of the Chief Financial Officer (OCFO) l.
was created as part of the NRC's January 5,1997, reorganization. The Office of the 5
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Controller has now been incorporated into the OCFO and the position of the Director, Office of the Controller (previously identified in the policy as having the issuing authority), has been subsumed by the CFO.
This section has also been modified to emphasize that the technical and regulatory significance of violations are considered in conjunction with the principles of the policy statement and the surrounding circumstances when the agency determines the appropriate enforcement strategy.
This section has also been revised to indicate that the Commission is to be provided notification (where appropriate, based on the uniqueness or significance of the issue) for a plant meeting the criteria of Section VII.B.6 (mitigation for violations involving special circumstances). This is consistent with the policy revision to Section VII issued on
' December 26,1996 (61 FR 68070).
IV. Severity of Violations l
This section has been modified such that minor violations will no longer be noted as Non-Cited Violations (NCVs) when they are documented in inspection reports. Instead, if a minor violation warrants documentation, it will be noted as a violation of minor significance .
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' that is not subject to formal enforcement action. The definition of an NCV included in footnote 6 has also been deleted. The purpose of these changes is to avoid confusion between 6
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l minor violations dispositioned as NCVs in accordance with Section IV and Severity Level IV i
violations dispositioned as NCVs in accordance with Section VII.B.1, " Licensee-Identified Severity LevelIV Violations." Use of the term "NCV" will now be reserved for those Severity Level IV violations that meet the criteria for discretion in Section VII.B.1.
V. Predecisional Enforcement Conferences i
This section has been modified to indicate that a predecisional enforcement conference is not required if the NRC has sufficient information to make an informed enforcement decision. If a conference is not held, the licensee may be requested to provide a written response to an inspection report as to the licensee's views on the apparent violations and their root causes and a description of planned or implemented corrective actions. (The previous discussion indicated that the licensee will normally be requested to provide a written response.)
It is the NRC's intent that this approach will normally be taken in the event a civil penalty is under consideration. This section has also been modified to include an additional option when
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l a conference is not held, such that the NRC may proceed to issue an enforcement action !
without first obtaining the licensee's response to the inspection report, if the NRC has sufficient information_to conclude that a civil penalty is not warranted. This approach would still: (1) provide licensees an opportunity to request a conference to dispute the action, (2) provide licensees an opportunity to dispute the action in writing through the provisions of 10 CFR 2.201 (as with any Notice of Violation), (3) allow the NRC to conduct a conference where matters are disputed or where the licensee's documented corrective actions are not 7
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P r sufficiently prompt and comprehensive, and (4) provide for modification or recision of the NOV, if appropriate.
I It should be noted that these modifications are not meant to be constnied as exclusive enforcement options. In other words, it does not change the existing practice whereby the NRC may choose to ir se an enforcement action (including civil penalties and orders) without conducting a conference. These changes are being made in an effort to make the enforcement process more efficient (by reducing the number of conferences and reducing the workload of both the NRC and licensees and improving the timeliness of enforcement actiois).
VI. Enforcement Actions This general discussion of the NRC's philosophy and approach to taking enforcement has been modified by including the recognition that circumstances regarding a violation may warrant discretion such that the NRC may refrain from issuing a Notice of Violation or other enforcement action. This discussion was previously included in Section VI.A, " Notice of Violation," and has been more appropriately relocated to this section.
A. Notice of Violation The NRC has had a long-standing policy that licensees are not ordinarily cited for violations resulting from matters not within their control, such as equipment failures that are 8
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! 4 not avoidable by reasonable licensee quality assurance measures or management controls.
This discussion has been deleted from this section and more appropriately included in the
! discussion on mitigation of sanctions in Section VII.B.6, " Violations Involving Special Circumstances."
l B. CivilPenalty
- 1. Base Civil Penalty .
i Table 1 A has been revised to correct the inadvertent omission of a footnote that indicates that large firms engaged in manufacturing or distribution of byproduct, source, or special nuclear material be considered as industrial processors. Table 1 A had included this footnote prior to the 1995 policy revision and this footnote was included in the table in the draft Federal Register notice that the Commission approved for publication and in the table in j Section II.D 7.c of NUREG-1525. Table 1A has also been revised to include additional j~ guidance in determining which category material users should be considered under by l
i including "other large material users" in category "c" and "other small materials users" in I category "d."
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L_-__ ___._ _ _ _ _ _ _ . _ _ _ _ _ . _ _ _ _ _ . _ . . . _ _ _ _ . . _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _____ _ _ _ _
f f VII. Exercise of Discretion .
B. Mitigation ofEnforcement SanctionsSection VII.B.1, " Licensee-Identified Severity Level IV Violations," is being modified to address licensee-identified violations that are identified as a result of an event. On December 10,1996 (61 FR 65088), the Commission issued a revision to the Enforcement Policy that included a modification to the criterion in Section VII.B.1.a. Specifically, the phrase " including identification through an event" was deleted from the criterion. The modification was intended to make it clear that use of discretion is not automatic if the violation is identified through an event. A footnote is being included to the criterion to address how the NRC will normally consider violations that are identified as a result of an event.
The Commission recognizes that there may be panicular circumstances in a case where discretion is warranted and the NRC should refrain from issuing enforcement action. Sections VII.B.3, VII.B.4, and VII.B.6 of the Enforcement Policy provide that discretion may be warranted for certain Severity level II and III violations. If the circumstances of a particular case may. warrant discretion at Severity Level II or III, then discretion may also be appropriate at Severity Level IV. Therefore, changes have been made to the examples to refiect that the NRC may choose to refrain from issuing a Notice of Violation for a Severity Level IV violation.
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Section VII.B.6 was also modified to include additional factors for consideration,
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including whether the regulatory requirement that was violated was clear, or given the NRC's current information, appropriate. As previously addressed, this section also includes that the NRC may refrain from issuing enforcement action for violations resulting from matters beyond a licensee's control. However, licensees are generally responsible for the actions ofits ,
employees. The revised text, consistent with long-standing NRC interpretation, makes it clear that licensees are also responsible for the actions of their contractors.
Appendix A: Safety and Compliance This appendix has been added to address the NRC's philosophy on the nexus between safety and compliance.
Appendix B: Supplements - Violation Examples This appendix was administratively created as a result of the addition of Appendix A and includes the previous guidance included in the Supplements section of the policy.
i Supplement VII - Miscellaneous Matters l
Examples B.4 and C.4 have been revised to reflect NRC practice in applying Severity 11
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i i Level II and III categorization for violations involving discrimination. In particular, Severity Level II categorization is appropriate for discriminatory acts by middle to upper management, not simply any level above first-line supervision. Severity Level III categorization is appropriate for low-level supervision and management, even if they are above a first-line supervisor.
Paperwork Reduction Act This policy statement does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
Existing requirements were approved by the Office of Management and Budget, approval number 31504)l36. The approved information collection requirements contained in this policy statement appear in Section VII.C.
Public Protection Notification The NRC may not ccnduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
Small Business Regulatory Enforcement Fairness Act In accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, 12
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the NRC has determined that this action is not a major rule and has verified this determination with the Office ofInformation and Regulatory Affairs of OMB.
Accordingly, the NRC Enforcement Policy is revised to read as follows:
GENERAL STATEMENT OF POLICY AND PROCEDURE FOR NRC ENFORCEMENT ACTIONS Table of Contents Preface I. INTRODUCTION AND PURPOSE II. STATUTORY AUTHORITY A. Statutory Authority B. Procedural Framework III. RESPONSIBILITIES IV. SEVERITY OF VIOLATIONS 13 j 1
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 14
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- 2. Orders 1
- 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 Enforcement Action 1
- 5. Violations Involving Discrimination
- 6. Violations Involving Special Circumstances C. Exercise of Discretion for an Operating Facility i
VIII. ENFORCEMENT ACTIONS INVOLVING INDIVIDUALS l
l IX. INACCURATE AND INCOMPLETE INFORMATION j X. ENFORCEMENT ACTION AGAINST NON-LICENSEES XI. REFERRALS TO THE DEPARTMENT OF JUSTICE
! XII. PUBLIC DISCLOSURE OF ENFORCEMENT ACTIONS l
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i XIII. IEOPENING CLOSED ENFORCEMENT ACTIONS APPENDIX A: SAFETY AND COMPLIANCE APPENDIX B: SUPPLEMENTS - VIOLATION EXAMPLES 16
f f
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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.8 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.
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:
, e As a deterrent to emphasize the importance of compliance with requirements, and l
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' Antitrust enforcement matters will be dealt with on a c.ase-by-case basis.
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s s e 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, contractors,2 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 this enforcement policy. In no case, however, will licensees who cannot achieve and maintain adequate levels of safety be permitted to conduct licensed activities.
For purposes of this policy statement, safety means avoiding undue risk, i.e., providing reasonable assurance of adequate protection for the public in connection with the use of source, byproduct and special nuclear materials. Compliance means meeting regulatory requirements. Appendix A to this policy statement describes the nexus between safety and compliance.
2 The term " contractor" as used in this policy includes vendors who supply products or services to be used in an NRC-licensed f acility or activity.
- 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. These non-licensees include contractors and subcontractors, holders of, or applicants for, NRC approvals, e.g., certificates of compbnce, early site permits, or standard design certificates and the employees of these non-licensees. Specific guidance regarding enforcement action against individuals and non licensees is addressed in Sections Vill and X, respectively.
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~ II. STATUTORY AUTHORITY AND PROCEDURAL FRAMEWORK 1
i A. Statutory Authority }
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l 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 u' nder 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
, i authorizes the NRC to impose civil penalties not to exceed $100,000 per violation per day for i
L- 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 l
- 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.
I Section 232 authorizes the NRC to seek injunctive or other equitable relief for violation of regulatory requirements.
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s s Section 206 of the Energy Reorganization Act authorizes the NRC to impose civil penalties for knowing and conscious failures to provide certain safety information to the NRC.
Notwithstanding the $100,000 limit stated in the Atomic Energy Act, the Commission may impose higher civil penalties as provided by the Debt Collection Improvement Act of 1996. Under the Act, the Commission is required to modify civil monetary penalties to reflect
' inflation.' The adjusted maximum civil penalty amount is reflected in 10 CFR 2.205 and this Policy Statement.
Chapter 18 of the Atomic Energy Act provides for varying levels of criminal penalties (i.e., monetary fines and imprisonment) for willful violations of the Act and regulations or orders issued under sections 65,161(b),161(i), or 161(o) of the Act. Section 223 provides that criminal penalties may be imposed on certain individuals employed by firms constructing or supplying basic components of any utilization facility if the individual knowingly and willfully violates NRC requirements such that a basic component could be significantly impaired. Section 235 provides that criminal penalties may be imposed on persons who interfere with inspectors. Section 236 provides that criminal penalties may be imposed on persons who attempt to or cause sabotage at a nuclear facility or to nuclear fuel. Alleged or l suspected criminal violations of the Atomic Energy Act are referred to the Department of Justice for appropriate action. 1 B. Procedural Framework 20
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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 1 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 1
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 21 l . _ - _ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ _ - - - - _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ ______ ___ ____
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, s 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 1
The Executive Director for Operations (EDO) and the principal enforcement officer of the NRC, the Deputy Executive Director for Regulatory Effectiveness, hereafter referred to as the Deputy Executive Director, has been delegated the authority to approve or issue all escalated enforcement actions.' The Deputy Executive Director is responsible to the EDO for the NRC enforcement program. The Office of Enforcement (OE) exercises oversight of and implements the NRC enforcement program. The Director, OE, acts for the Deputy Executive Director in enforcement matters in his absence or as delegated.
Subject to the oversight and direction of OE, and with the approval of the Deputy Executive Director, where necessary, the regional offices normally issue Notices of Violation and proposed civil penalties. However, subject to the same oversight as the regional offices, the Office of Nuclear Reactor Regulation (NRR) and the Office of Nuclear Material Safety and Safeguards (NMSS) may also issue Notices of Violation and proposed civil penalties for certain activities. Enforcement orders are normally issued by the Deputy Executive Director or the Director, OE. However, orders may also be issued by the EDO, especially those
- 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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a e involving the more significant matters. The Directors of NRR and NMSS have also been delegated authority to issue orders, but it is expected that normal use of this authority by NRR and NMSS will be confined to actions not associated with compliance issues. The Chief Financial Officer has been delegated the authority to issue orders where licensees violate Commission regulations by nonpayment of license and inspection fees.
In recognition that the regulation of nuclear activities in many cases does not lend itself to a mechanistic treatment, judgment and discretion must be exercised in determining the severity levels of the violations and the appropriate enforcement sanctions, including the decision to issue a Notice of Violation, or to propose or impose a civil penalty and the amount of this penalty, after considering the general principles of this statement of policy and the technical and regulatory significance of the violations and the surrounding circumstances.
Unless Commission consultation or notification is required by this policy, the NRC staff may depart, where warranted in the public's interest, from this policy as provided in Section VII, " Exercise of 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 the first time that discretion is exercised for a plant meeting the criteria of Section VII.B.2. The Commission is also to be provided notification (where appropriate, based on the uniqueness or significance of the issue) for a plant meeting the criteria of 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 23
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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 I
potential radiological or other hazards associated with continued operation; (2) Proposals to impose a civil penalty for a single violation or problem that is greater than 3 times the Severity Level I value shown in Table 1 A for that class of licensee; (3) Any proposed enforcement action that involves a Severity I2 vel I violation; (4) Any action the EDO believes warrants Commission involvement; (5) Any proposed enforcement case involving an Office ofInvestigations (OI) report where the NRC staff (other than the OI staff) does not arrive at the same conclusions as those in the OI report concerning issues of intent if the Director of 01 concludes that Commission consultation is warranted; and (6) Any proposed enforcement action on which the Commission asks to be consulted.
IV. SEVERITY OF VIOLATIONS 24
- P Regulatory requirements5 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 Erst step in the enforcement process. In considering the significance of a violation, the staff considers the technical significance, i.e., actual and potential consequences, and the regulatory significance. In evaluating the technical significance, risk is an appropriate consideration.
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.
l 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.
l 25 l
l l
i 1
, ~
Licensed activities will be placed in the activity area most suitable in light of the i
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., ifleft 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 will be noted as violations of minor significance that are not subject to formal enforcement action.
26
s e 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 i i
I 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 i
adjustment to the severity level categorization.
A. Aggregation of Violations A group of Severhy 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 l
the violations have the same underlying cause or programmatic deficiencies, or the violations 1
l l
27 l
l E________________.
4 83 l
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.
1 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-L III, if the violation can be considered a repetitive violation.6 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, l
the similarity of the violations and their root causes, the acequacy of previous corrective actions, the period of time between the violations, and the significance of the violations.
- 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.
28
L
- e. o l.
l l C. Willful Violations l Willful violations are by definition of particular concern to the Commission because its 1
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 i
' the Commission or a licensee. Licensees are expected to take significant remedial action in l-responding to willful violations commensurate with the circumstances such that it demonstrates .
l the seriousness of the violation thereby creating a deterrent effect within the licensee's l
! _ organization. Although removal of the person is not necessarily required, substantial L
i disciplinary action is expected.
Therefore, the severity level of a violation may be increased if the circumstances L
j 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 L of violations ranging from deliberate intent to violate or falsify to and including careless L 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 i
i 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 l violation (e.g., licensee official 7or non-supervisory employee), the significance of any j l
i l
' The term " licensee official" as used in this policy statement means a first-Ime 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 ;
29
underlying violation, the intent of the violator (i.e., careless disregard or deliberateness), and the economic or other advantage, if any, gained as a result of the violation. The relative weight given to each of these factors in arriving at the 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.
D. Violations ofReporting 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.
l 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.
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 individu#s responsibilities relative to the oversight of licensed activities and to the use of licensed material.
30 1
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ._____-_-___________________ - _ - ___ - ~
l V. PREDECISIONAL ENFORCEMENT CONFERENCES l Whenever the NRC has learned of the existence of a potential violation for which escalated enforcement action appears to be warranted, or recurring nonconformance on the part of a contractor, the NRC may provide an opportunity for a predecisional enforcement conference with the licensee, contractor, or other person before taking enforcement action.
The purpose of the conference is to obtain information that will assist the NRC in determining the appropriate enforcement action, such as: (1) a common understanding of facts, root causes and missed opportunities associated with the apparent violations, (2) a common understanding of corrective actions taken or planned, and (3) a common understanding of the significance of
. issues and the need for lasting comprehensive corrective action.
If the NRC concludes that it has sufficient inforrnation to make an informed enforcement decision, a conference will not normally be held. However, an opportunity for a conference will normally be provided before issuing an order based on a violation of the rule on Deliberate Misconduct or a civil penalty to an unlicensed person. If a conference is not held, the licensee may be requested to provide a written response to an inspection report, if issued, as to the licensee's views on the apparent violations and their root causes and a i description of planned or implemented corrective actions. However, if the NRC has sufficient information to conclude that a civil penalty is not warranted, it may proceed to issue an :
i enforcement action without first obtaining the licensee's response to the inspection report.
31
- I
- e During the predecisional enforcement conference, the licensee, contractor, 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, contractors, or other persons will be told when a meeting is a predecisional enforcement conference.
A predecisional enforcement conference is a meeting between the NRC and the licensee. Conferences are normally held in the regional offices and are normally open to j
public observation. Conferences will not normally be open to the public if the enforcement action being contemplated:
(1) W ould 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 l
j .
I individual (s) involved be present at the conference; I
(3) Is based on the findings of an NRC Office of Investigations report that has not been i
i publicly disclosed; or 32 i
e (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: 1 i
(5) The conference involves medical misadministration or overexposure and the i
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.
I Notwithstanding meeting any of these criteria, a conference may still be open if the conference involves issues related to an ongoing adjudicatory proceeding with one or more interveners or where the evidentiary basis for the conference is a matter of public record, such as an adjudicatory decision by the Department of Labor. In addition, notwithstanding the above normal criteria for opening or closing conferences, with the approval of the Executive Director for Operations, conferences may either be open or closed to the public after balancing the benefit of the public's observation against the potential impact on the agency's decision-making process in a particular case.
The NRC will notify the licensee that the conference will be open to public observation. Consistent with the agency's policy on open meetings, " Staff Meetings Open to 33 L______________________- _
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-%74, (3) >
a toll-free electronic bulletin board at 800-952-%76, and on the World Wide Web at the NRC Office of Enforcement homepage (www.nrc. gov /OE). 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 may observe but may not participate in the conference. It is noted that the purpose of conducting open conferences is not to maximize public attendance, but rather to provide the public with opportunities to be informed of NRC i
activities consistent with the NRC's ability to exercise its regulatory and safety responsibilities. Therefore, members of the public will be allowed access to the NRC regional i
offices to attend open enforcement conferences in accordance with the " Standard Operating Procedures For Providing Security Support For NRC Hearings and Meetings," published I
November 1,1991 (56 FR 56251). These procedures provide that visitors may be subject to i
personnel screening, that signs, banners, posters, etc.,' not larger than 18" be permitted, and l that disruptive persons may be removed. The open conference will be terminated if disruption interferes with a successful conference. NRC's Predecisional Enforcement Conferences 1
(whether open or closed) normally will be held at the NRC's regional offices or in NRC Headquarters Offices and not in the vicinity of the licensee's facility.
l J
34 l
v For a case in which an NRC Office of Investigations (OI) report finds that i i
discrimination as defined under 10 CFR 50.7 (or similar provisions in Parts 30,40, 60, 70, or !
k
- 72) has occurred, the 01 report may be made public, subject to withholding certain J information (i.e., after appropriate redaction), in which case the associated predecisional d
enforcement conference will normally be open to public observation. In a conference where a particular individual is being considered potentially responsible for the discrimination, the conference will remain closed. In either case (i.e., whether the conference is open or closed),
' the employee or former employee who was the . subject of the alleged discrimination (hereafter referred to as " complainant") will normally be provided an opportunity to participate in the predecisional enforcement conference with the licensee / employer. This participation will normally be in the form of a complainant statement and comment on the licensee's presentation, followed in turn by an opportunity for the licensee to respond to the l' complainant's presentation. In cases where the complainant is unable to attend in person, arrangements will be made for the complainant's participation by telephone or an opportunity given for the complainant to submit a written response to the licensee's presentation. If the licensee chooses to forego an enforcement conference and, instead, responds to the NRC's i findings in writing, the complainant will be provided the opportunity to submit written !
comments on the licensee's response. For cases involving potential discrimination by a contractor, any associated predecisional enforcement conference with the contractor would be handled similarly. These arrangements for complainant participation in the predecisional enforcement conference are not to be conducted or viewed in any respect as an adjudicatory 1
hearing. The purpose of the complainant's participation is to provide information to the NRC 35
l o y to assist it in its enforcement deliberations. I A predecisional enforcement conference may not need to be held in cases where there is a full adjudicatory record before the Department of Labor. If a conference is held in such cases, genera!!y the conference will focus on the licensee's corrective action. As with discrimination cases based on OI investigations, the complainant may be allowed to participate.
Members of the public attending open conferences will be reminded that (1) the apparent violations discussed at predecisional enforcement conferences are subject to further review and may be subject to change prior to any resulting enforcement action and (2) the statements of views or expressions of opinion made by NRC employees at predecisional enforcement conferences, or the lack thereof, are not intended to represent final determinations or beliefs.
When needed to protect the public health and safety or common defense and security, escalated enforcement action, such as the issuance of an immediately effective order, will be taken before the conference. In these cases, a conference raay be held after the escalated enforcement action is taken.
36
e v l 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.
However, circumstances regarding the violation findings may warrant discretion being exercised such that the NRC refrains from issuing a Notice of Violation or other enforcement j i
action. (See Section VII.B, " Mitigation of Enforcement Sanctions.")
37 l
l
u ,
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 fonnalizing the existence of a violation. Issuance of a Notice of Violation is normally the only enforcement action taken, except in cases where the criteria for issuance of civil penalties and orders, as set forth in Sections VI.B and VI.C, respectively, are met.
B. Civil Penalty A civil penalty is a monetary penalty that may be imposed for violation of (1) certain specified licensing provisions of the Atomic Energy Act or supplementary NRC rules or 38
u ..
l l
I 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 correc ive action.
i Civil penalties are considered for Severity Level III violations. In addition, civil penalties will normally be assessed for Severity Level 1 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 i
regulatory concern. I i
Although management involvement, direct or indirect, in a violation may lead to an 1
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 in~volvement in licensed activities and a decrease in protection of the public health and safety.
l l
l
- 1. Base Cint Penahy 39
)
.. u The NRC imposes different levels of penalties for different severity level violations and different classes of licensees, contractors, and other persons. Tables l A and IB show the base I
civil penalties for various reactor, fuel cycle, and materials programs. (Civil penalties issued to individuals are determined on a case-by-case basis.) The structure of these tables generally takes into account the gravity of the violation as a primary consideration and the ability to pay as a secondary consideration. Generally, operations involving greater nuclear material inventories and greater potential consequences to the public and licensee employees receive higher civil penalties. Regarding the secondary factor of ability of various classes of licensees to pay the civil penalties, it is not the NRC's intention that the economic impact of a civil penalty be so severe that it puts a licensee out of business (orders, rather than civil penalties, are used when the intent is to suspend or terminate licensed activities) or adversely affects a licensee's ability to safely conduct licensed activities. The deterrent effect of civil penalties is best served when the amounts of the penalties take into account a licensee's ability to pay. In determining the amount of civil penalties for licensees for whom the tables do not reflect the ability to pay or the gravity of the violation, the NRC will consider as necessary an increase or decrease on a case-by-case basis. Normally, if a licensee can demonstrate financial hardship, the NRC will consider payments over time, including interest, rather than reducing the amount of the civil penalty. However, where a licensee claims financial hardship, the licensee will normally be required to address why it has sufficient resources to safely conduct licensed activities and pay license and inspection fees.
- 2. Civil Penalty Assessment 40
u ..
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 1 A and IB for Severity Level I,-II, and III violations as described below.
The civil penalty assessment process considers four decisional points: (a) whether the licensee has had any previous escalated enforcement action (regardless of the activity area) during the past 2 years or past 2 inspections, whichever is longer; (b) whether the licensee should be given credit for actions related to identification; (c) whether the licensee's corrective actions are prompt and comprehensive; and (d) whether, in view of all the circumstances, the matter in question requires the exercise of discretion. Although each of these decisional points may have several associated considerations for any given case, the outcome of the assessment process for each violation or problem, absent the exercise of discretion, is limited to one of the following three results: no civil penalty, a base civil penalty, or a base civil penalty escalated by 100%. The flow chart presented below is a graphic representation of the civil penalty assessment process.
l l
41
.. u YES I O
CP YES CA CREDIT
?
1st NON-WILLFUL SL lli NO IN YES 2Yl21 SE ID CP
/ REDIT
- 7 YES NO CA CREDIT
?
BASE NO CP
+100%
- should the licensee be given credit for actions related to identification?
Diecretion, e_ft., SL I and la vloistions should norme#y resuN in a civil penalty i.y -": . x of ID and CA.
- 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 42
u ..
4 l 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.
1 i
- b. Creditfor Actions Related to identification (I) If a Severity I2 vel I or 11 violation or a willful Severity Ixvel III violation has i occurred--or if, during the past 2 years or 2 inspections, whichever is longer, the licensee has l 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 l
corrective action. In other words, although giving credit for Idennfication and Corrective 43
Action should be separate decisions, the concept ofIdentification 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-8 identified, or revealed through 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; 8
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 discl> sed an l overexposure, the issue would be considered an event.
44
u .. l (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 1
(vii) For cases in which the NRC identifies the overall problem requiring corrective l l
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 opponunities existed to identify the problem.
l (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 45
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 cf the NRC inspector's discovery (e.g., conducting a walkdown, observing in the control room, performing a 46
confirmatory NRC radiation survey, hearing a cavitating pump, or finding a valve obviously out of position). In some cases, the licensee's missed oppormnities to identify the problem might include a similar previous violation, NRC or industry notices, internal audits, or readily observable trends.
1 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 1
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 l of the problem.
(iv) . Mixed Identification. For " mixed" identification situations (i.e., where multiple violations exist, some NRC-identified, some licensee-identified, or where the NRC prompted the licensee to take action that resulted in the identification of the violation), the NRC's evaluation should normally determine whether the licensee could reasonably have been expected to identify the violation in the NRC's absence. This determination should consider, ,
l 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 I NRC's path of analysis had been dismissed or was being pursued in parallel by the licensee.
1 l
( 47 l
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 surveillance, 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 opponunities 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).
48
m ..
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 l
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 l
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")
- l. unless the number of opportunities missed was particularly significant.
The timing of the missed opportunity should also be considered. While a rigid time-l frame is unnecessary, a 2-year period should generally be considered for consistency'in implementation, as the period reflecting relatively current performance.
l (3) When the NRC determines that the licensee should receive credit for actions related L
I.
to Identifcatior, the civil penalty assessment should normally result in either no civil penalty or a base civil penahy, 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, !
1 the civil penalty assessment should normally result in a Notice of Violation with either a base )
49 i
i
action is focused narrowly to the specific violation or broadly to the general area of concern).
Even in cases when the NRC, at the time of the enforcement conference, identifies additional peripheral or minor corrective action still to be taken, the licensee may be given credit in this area, as long as the licensee's actions addressed the underlying root cause and are considered sufficient to prevent recurrence of the violation and similar violations.
Normally, the judgment of the adequacy of corrective actions will hinge on whether the NRC had to take action to focus the licensee's evaluative and corrective process in order to obtain comprehensive corrective action. This will normally be judged at the time of the predecisional enforcement conference (e.g., by outlining substantive additional areas where corrective action is needed). Earlier informal discussions between the licensee and NRC inspectors or management may result in improved corrective action, but should not normally be a basis to deny credit for Corrective Action. For cases in which the licensee does not get credit for actions related to Identr]ication 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 ideritified, corrective action would not be considered prompt and comprehensive.
51
.s - ,.
Corrective action for violations involving discrimination should normally only be considered comprehensive if the licensee takes prompt, comprehensive corrective action that (1) addresses the broader environment for raising safety concerns in the workplace, and (2) provides a remedy for the particular discrimination at issue.
In response to violations of 10 CFR 50.59, corrective action should normally be considered prompt and comprehensive only if the licensee (i) Makes a prompt decision on operability; and either (ii) Makes a prompt evaluation under 10 CFR 50.59 if the licensee intends to maintain
. the facility or procedure in the as found condition; or (iii) Promptly initiates corrective action consistent with Criterion XVI of 10 CFR 50, Appendix B, if it intends to restore the facility or procedure to the FSAR description.
- d. Exercise of Discretion 1
- . As provided in Section VII, " Exercise of Discretion," discretion msy 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 52
_ _ _ . _ _ _ _ _ _ _ _ _ _ _ = _ _ - _ - _-_-- -. - . _ _ - .- - __. - - - . _ _ _ _ _ . _ - ._
' licensee. However, in no instance will a civil penalty for any one violation exceed $110,000 per day.
TABLE 1A-BASE CIVIL PENALTIES
- a. Power reactors and gaseous diffusion plants...... 5110,000
- b. Fuel fabricators, industrial processors,'
and independent spent fuel and monitored retrievable storage installations . . . . . . . . . . . . . . . . . . . . . . . 527,500
- c. Test reactors, mills and uranium conversion facilities, contractors, waste disposal licensees, industrial radiographer, and other large material users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $11,000
- d. Research reactors, academic, medical, or other small material users . . . . .2 . . . . . . . . . . . . . . . . . . . . . . . $5,500 3 Large firms engaged in manufacturing or distribution of byproduct, source, or special nuclear material.
2 This applies to nonprofit institutions not otherwise categorized in this table, mobile nuclear services, nuclear pharmacies, and physician offices.
53
(a) To remove a threat to the public health and safety, common defense and security, or the environment; l (b) To stop fa'cility construction when, l
(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 t
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 1 licensed activity is not suspended (nor is a suspension prolonged) for failure ~to comply with 55 l
l l
I
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; l
(c) When licensee does not respond to a Notice of Violation where a response was required; i
(d) When a licensee refuses to pay an applicable fee under the Commission's regulations; or !
)
I (e) For any other reason for which revocation is authorized under section 186 of the Atomic Energy Act (e.g., any condition which would warrant refusal of a license on an original application).
- 4. Cease and Desist Orders may be used to stop an unauthorized activity that has continued after notification by the NRC that the activity is unauthorized.
- 5. Orders to non-licensees, including contractors and subcontractors, holders of NRC 56
1 approvals, e.g., certificates of compliance, early site permits, standard design certificates, or i applicants for any of them, and to employees of any of the foregoing, are used when the NRC 1
has identified deliberate misconduct that may cause a licensee to be in violation of an NRC l l
requirement or where incomplete or inaccurate information is deliberately submitted or where j the NRC loses its reasonable assurance that the licensee will meet NRC requirements with that l person involved in licensed activities. j Unless a separate response is warranted pursuant to 10 CFR 2.201, a Notice of l
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.
l Orders are made effective immediately, without prior opponunity for hearing, whenever it is determined that the public health, interest, or safety so requires, or when the !
i order is responding to a violation involving willfulness. Otherwise, a prior opportunity for a f i
hearing on the order is afforded. For cases in which the NRC believes a basis could l reasonably exist for not taking the action as proposed, the licensee will ordinarily be afforded i 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 57 l
orders, the NRC also uses administrative actions, such as Notices of Deviation, Notices of Nonconformance, Confirmatory Action Letters, Letters of Reprimand, and Demands for Information to supplement its enforcement program. The NRC expects licensees and contractors to adhere to any obligations and commitments resulting from these actions and_will not hesitate to issue appropriate orders to ensure that these obligations and commitments are met.
- 1. Notices of Deviation are written notices describing a licensee's failure to satisfy a commitment where the commitment involved has not been made a legally binding requirement.
A Notice of Deviation requests a licensee to provide a written explanation or statement describing corrective steps taken (or planned), the results achieved, and the date when corrective action will be completed.
- 2. Notices of Nonconformance are written notices describing contractors' failures to meet commitments which have not been made legally binding requirements by NRC. An L example is a commitment made in a procurement centract with a licensee as required by 10 CFR Part 50, Appendix B. ' Notices of Nonconformances request non-licensees to provide written explanations or statements describing corrective steps (taken or planned), the results achieved, the dates when corrective actions will be completed, and measures taken to preclude recurrence.
- 3. Confirmatory Action Letters are letters confirming a licensee's or contractor's 58
agreement to take certain actions to remove significant concerns about health and safety, safeguards, or the environment.
l l 12tters of Reprimand are letters addressed to individuals subject to Commission 4.
jurisdiction identifying a significant deficiency in their performance of licensed activities.
- 5. Demands for Information are demands for information from licensees or other persons for the purpose of enabling the NRC to determine whether an order or other enforcement action should be issued.
VII. EXERCISE OF DISCRETION Notwithstanding the normal guidance contained in this policy, as provided in Section III, " Responsibilities," the NRC may choose to exercise discretion and either escalate or mitigate enforcement sanctions within the Commission's statutory authority to ensure that the resulting enforcement action 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 59
not result in an appropriate sanction, with the approval of the Deputy Executive Director and consultation with the EDO and Commission, as warranted, the NRC may apply its full enforcement authority where the action is warranted. NRC action may include (1) escalating civil penalties, (2) issuing appropriate orders, and (3) assessing civil penalties for continuing violations on a per day basis, up to the statutory limit of SI10,000 per violation, per day.
- 1. Civilpenalties. 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 1
circumstances and conveys the appropriate regulatory message to the licensee. The l Commission will be notified if the deviation in the amount of the civil penalty proposed under this discretion from the amount of the civil penalty assessed under the normal process is more than two times the base civil penalty shown in Tables 1 A and IB. Examples when this discretion should be considered include, but are not limited to the following:
i 1
(a) Problems categorized at Severity Level I or II; (b) Overexposure, or releases of radiological material in excess of NRC requirements; 60 l
i (c) Situations involving particularly poor licensee performance, or involving willfulness; (d) Situations when the licensee's previous enforcement history has been particularly poor, or when the current violation is directly repetitive of an earlier violation; (e) Situations when the violation results in a substantial increase in risk, including l
cases in which the duration of the violation has contributed to the substantial increase; j i
I (f) Situations when the licensee made a conscious decision to be in noncompliance i
in order to obtain an economic benefit; i
(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 i
transfer of the material to an authorized recipient; or (h) Severity Level II or III violations associated with departures from the Final Safety Analysis Report identified after two years from October 18,1996. Such a violation or problem would consider the number and nature of the violations, the severity of the violations, whether the violations were continuing, and who identified the violations (and if the licensee l
identified the violation, whether exercise of Section VII.B.3 enforcement discretion is I 61 l
l -_ . _ - _ _ - _ _ - -
warranted).
- 2. Orders. The NRC may, where necessary or desirable, issues orders in conjunction with or in lieu of civil penalties to achieve or formalize corrective actions and to
- deter further recurrence of serious violations.
- 3. Daily civilpenalties. In order to recognize the addeci 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 $110,000 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 Sections VI.A and 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 th: licensee's failure to make a required report. The approval of the Director, Office of Enforcement, with 62
- consultation with the 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 6. Commission notification is required for exercising discretion of the type described in: (1)Section VII.B.2 the first time discretion is exercised during that plant shutdown, and (2)Section VII.B.6 where appropriate based on the uniqueness or significance of the issue. Examples when discretion should be considered for departing from the normal approach in Sections VI.A and VI.B include, but are 2
not limited to the following:
- 1. Licensee-Identified Severity LevelIV Violations. The NRC, with the approval of the Regional Administrator or his or her 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;'
(b) It was not a violation that could reasonably be expected to have been prevented l
' Discretion is not warranted when a licensee identifies a violation as a result of an event where the root cause of the event is obvious or the licensee had prior opportunity to identify the problem but failed to take action that would have prevented the event. Discretion may be warranted if the licensee demonstrated initiative in identifying the violation's root cause.
63
. ,o 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);
1 64
(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) Signi0 cant 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 Identyled During Extended Shutdowns or Work Stoppages. The NRC may refrain from issuing a Notice of Violation or a proposed civil penalty for a violation that is identified after (i) the NRC has taken significant enforcement action based upon a major safety event contributing to an extended shutdown of an operating reactor or a material licensee (or a work stoppage at a construction site), or (ii) the licensee enters an extended shutdown or work stoppage related to generally poor performance over a long period of time, provided that the violation is documented in an inspection report (or official field notes for some material cases) and that it meets all of the following criteria:
(a) . It was either licensee-identified as a result of a comprehensive program for problem identification and correction that was developed in response to the shutdown or 65
identified as a result of an employee allegation to the licensee; (If the NRC identifies the violation and all of the other criteria are met, the NRC should determine whether enforcement action is necessary to achieve remedial action, or if discretion may still be appropriate.)
(b) It is based upon activities of the licensee prior to the events leading to the shutdown; (c) It would not be categorized at Severity Level I; (d) It was not willful; and (e) The licensee's decision to restart the plant requires NRC concurrence.
- 3. Violations involving Old Design issues. The NRC may refrain from proposing a civil penalty for a Severity Level II or III violation involving a past problem, such as in engineering, design, or installation, provided that the violation is documented in an inspection report (or official field notes for some material cases) that includes a description of the corrective action and that it meets all of the following criteria:
(a) It was a licensee-identified as a result of its voluntary initiative; 66
l (b) It was or will be corrected, including immediate corrective action and long term comprehensive corrective action to prevent recurrence, within a reasonable time followmg i I
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 i licensee efforts cuch as normal surveillance or quality assurance (QA) activities.
In addition, the NRC may refrain from issuing a Notice of Violation for a Severity Level II, III, or IV violation that meets the above criteria provided the violation was caused by conduct that is not reasonably linked to present performance (normally, violations that are at least 3 years old or violations occurring during plant construction) and there had not been prior notice so that the licensee should have reasonably identified the violation earlier. This exercise of discretion is to place a premium on licensees initiating efforts to identify and correct subtle violations that are not likely to be identified by routine efforts before degraded safety systems are called upon to work.
Section VII.B.3 discretion would not normally be applied to departures from the FSAR if: i l
l (a) The NRC identifies the violation unless it was likely in the staff's view that the l l
l licensee would have identified the violation in light of the defined scope, thoroughness, and 67 l
schedule of the licensee's initiative (provided the schedule provides for completion of the licensee's initiative within two years after October 18, 1996; (b) The licensee identifies the violation as a result of an event or surveillance or other required testing where required corrective action identifies the FSAR issue; (c) The licensee identifies the violation but had prior opponunities to do so (was aware of the departure from the FSAR) and fciled to correct it earlier:
(d) There is willfulness associated with the violation; (e) The licensee fails to make a report required by the identification of the departure from the FSAR; or (f) The licensee either fails to take comprehensive corrective action or fails to appropriately expand the corrective action program. The corrective action should be broad with a defined scope and schedule.
- 4. Violations dennfied Due to Previous Enforcement Action. The NRC may refrain from issuing a Notice of Violation or a proposed civil penalty for a violation that is 68
1 identified after the NRC has taken enforcement action, provided that the violation is documented in an inspection report (or official field notes for some material cases) that j l !
l includes a description of the corrective action and that it meets all of the following criteria: ;
l 1
(a) It was licensee-identified as part of the corrective action for the previous enforcement action; (b) It has the same or similar root cause as the violation for which enforcement action was issued; (c) It does not substantially change the safety significance or the character of the regulatory concern arising out of the initial violation; and (d) It was or will be corrected, including immediate corrective action and long term comprehensive corrective action to prevent recurrence, within a reasonable time following identification.
(e) It would not be categorized at Severity Level I;
- 5. Violations involving Cenain 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, 69
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 di",crimination 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, 'he NRC may exercise its discretion not to take enforcement action when the licensee has addressed the overall work envirotunent 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 (n, 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 violr: ions), allegations of discrimination where a history of findings of discrimination (by the DOL or the NRC) or 70
settlements suggests a programmatic rather than an isolated discrimination problem, or ,
allegations of discrimination which appear particularly blatant or egregious.
)
- 6. Violations Involving Special Circumstances. Notwithstanding the outcome of the normal enforcement process addressed in Section VI.A or the normal civil penalty assessment process addressed in Section VI.B, the NRC may reduce or refrain from issuing a civil penalty or a Notice of Violation for a Severity Level II, III, or IV violation based on the merits of the case after considering the guidance in this statement of policy and such factors as the age of the violation, the technical and regulatory significance of the violation, the clarity of the requirement, the appropriateness of the requirement, the overall sustained performance of the licensee has been particularly good, and other relevant circumstances, including any that may have changed since the violation. This discretion is expected to be exercised only where application of the normal guidance in the policy is unwarranted. In addition, the NRC may refrain from issuing enforcement action for violations resulting from matters not within a licensee's control, such as equipment failures that were not avoidable by reasonable licensee quality assurance measures or management controls. Generally, however, licensees are held responsible for the acts of their employees and contractors. Accordingly, this policy should not be construed to excuse personnel or contractor errors.
C. Exercise ofDiscretionfor an Operating Facility i
On occasion, circumstances may arise where a licensee's compliance with a Technical 71 l
Specification (TS) Limiting Condition for Operation or with other license conditions would -
involve an unnecessary plant transient or performance of testing, inspection, or system realignment that is inappropriate with the specific plant conditions, or unnecessary delays in plant startup without a corresponding health and safety benefit. 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 l
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 72 l
l
f e. ..
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 l
l 73
chosen to issue a NOED. enforcement action will noimally 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 sta'ff 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 knowi- .< careless disregard (i.e., with more than mere negligence) failed to take requirr ' . ., o '
- h have actual or potential
l %. .
l 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.
e Inadvenently 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.
e Individual error directly resulting from following the technical advice of an 75
,. ,r expert unless the advise was clearly unreasonable and the licensed individual should have recognized it as such. Y
- e. 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:
e Willfully causing a licensee to be in violation of NRC requirements, e 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.
e Recognizing a violation of procedural requirements and willfully not taking i
corrective action. )
e Willfully defeating alarms which have safety significance.
- e Unauthorized abandoning of reactor controls. i e Dereliction of duty.
76
_______________ _ __ )
sg . ,,
e Falsifying records required by NRC regulations or by the facility license.
e 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.
e Willfully withholding safety significant information rather than making such information known to appropriate supervisory or technical personnel in the licensee's
- organization.
e Submitting false information and as a result gaining unescorted access to a nuclear power plant.
e 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.
e Willfully providing false certification that components meet the requirements of their intended use, such as ASME Code, e Willfully supplying, by contractors of equipment for transportation of radioactive material, casks that do not comply with their certificates of compliance.
e Willfully performing unauthorized bypassing of required reactor or other facility safety systems, o 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 77 l'
I
considering all the relevant circumstances surrounding the emergency.)
r 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.
78
<. a
- 7. The attitude of the wrongdoer, e.g., admission of wrongdoing, acceptance of responsibility.
- 8. The degree of management responsibility or culpability.
- 9. Who identified the misconduct.
Any proposed enforcement action involving individuals must be issued with the concurrence of the Deputy Executive Director. The particular sanction to be used should be determined on a case-by-case basis.* 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.
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:
l
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.
79 l
l
- 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.
1 o Require notification to the NRC before resuming work in licensed activities.
e 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 iss.ie 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 i ;nsed operator 80
- i. .,
exceeds those cutoff levels. A licensed operator or applicant who refuses to participate in the drug and alcohol testing programs established by the facility licensee or who is involved in the sale, use, or possession of an illegal drug is also subject to license suspension, revocation, or denial.
In addition, the NRC may take enforcement action against a licensee that may impact an individual, where the conduct of the individual places in question.the NRC's reasonable assurance that licensed activities will be properly conducted. The NRC may take enforcement action for reasons that would warrant refusal to issue a license on an original application.
Accordingly, appropriate enforcement actions may be taken regarding matters that raise issues of integrity, competence, fitness-for-duty, or other matters that may not necessarily be a violation of specific Commission requirements.
In the case of an unlicensed person, whether a firm or an individual, an order modifying the facility license may be issued to require (1) the removal of the person from all licensed activities for a specified period of time or indefinitely, (2) prior notice to the NRC before utilizing the person in licensed activities, or (3) the licensee to provide notice of the issuance of such an order to other persons involved in licensed activities making reference inquiries. In addition, orders to employers might require retraining, additional oversight, or independent verification of activities performed by the person, if the person is to be involved in licensed activities.
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i 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 i
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.
82
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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, enforceinent 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 I 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 I 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 l the misinformation is identified after the NRC relies on it, or after some question is raised I
regarding the accuracy of the information, then some enforcement action normally will be i taken even if it is in fact corrected. However, if the initial submittal was accurate when made i
I 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 83
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 tmstworthiness, the Commission may exercise its authority to issue orders i 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. i X. ENFORCEMENT ACTION AGAINST NON-LICENSEES The Commission s enforcement policy is also applicable to non-licensees, including contractors and subcontractors, holders of NRC approvals, e.g., certificates of compliance, early site permits, standard design certificates, quality assurance program approvals, or 84 l
applicants for any of them, and to employees of any of the foregoing, who knowingly provide components, equipment, or other goods or services that relate to a licensee's activities subject to NRC regulation. The prohibitions and sanctions for any of these persons who engage in deliberate misconduct or knowing submission of incomplete or inaccurate information are provided in the rule on deliberate misconduct, e.g.,10 CFR 30.10 and 50.5.
Contractors who supply products or services provided for use in nuclear activities are subject to certain requirements designed to ensure that the products or services supplied that could affect safety are of high quality. Through procurement contracts with licensees, suppliers may be required to have quality assurance programs that meet applicable requirements, e.g.,10 CFR Part 50, Appendix B, and 10 CFR Part 71, Subpart H.
Contractors supplying certain products or services to licensees are subject to the requirements of 10 CFR Part 21 regarding reporting of defects in basic components.
When inspections determine that violations of NRC requirements have occurred, or that contractors have failed to fulfill contractual commitments (e.g.,10 CFR Part 50, Appendix B) that could adversely affect the quality of a safety significant product or service, enforcement action will be taken. Notices of Violation and civil penalties will be used, as appropriate, for licensee failures to ensure that their contractors have programs that meet applicable requirements. Notices of Violation will be issued for contractors who violate 10 CFR Part 21.
Civil penalties will be imposed against individual directors or responsible officers of a contractor organization who knowingly and consciously fail to provide the notice required by 85
(
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.. .a 10 CFR 21.21(b)(1). Notices of Nonconformance will be used for contractors who 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 w.i th 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 ac ions 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 86
l ". . j l
i If significant new information is received or obtained by NRC which indicates that an l 1
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 I
a sanction or to correct the record. Reopening decisions will be made on a case-by-case basis, l
are expected to occur rarely, and require the specific approval of the Deputy Executive Director.
I APPENDIX A: SAFETY AND CO.41PLIANCE j As commonly understood, safety means freedom from exposure to danger, or 1
protection from harm. In a practical sense, an activity is deemed to be safe if the perceived risks are judged to be acceptable. The Atomic Energy Act of 1954, as amended, establishes
" adequate protection" as the standard of safety on wnich NRC regulation is based. In the context of NRC regulation, safety means avoiding undue risk or, stated another way, providing reasonable assurance of adequate protection for the public in connection with the use of source, byproduct and special nuclear materials.
The definition of compliance is much simpler. Compliance simply means meeting applicable regulatory requirements. The relationship between compliance and safety is I
discussed below.
e Safety is the fundamental regulatory objective, and compliance with NRC requirements 87
.. .s plays a fundamental role in giving the NRC confidence that safety is being maintained.
NRC requirements, including technical specifications, other license conditions, orders, and regulations, have been designed to ensure adequate protection--which corresponds l
to "no undue risk to public health and safety"--through acceptable design, construction, l
1 operation, maintenance, modification, and quality assurance measures. In the context i
)
l of risk-informed regulation, compliance plays a very important role in ensuring that key assumptions used in underlying risk and engineering analyses remain valid.
l
- Adequate protection is presumptively assured by compliance with NRC requirements.
Circumstances may arise, however, where new information reveals, for example, that i
an unforeseen hazard exists or that there is a substantially greater potential for a known l
i I hazard to occur. In such situations, the NRC has the statutory authority to require licensee action above and beyond existing regulations to maintain the level of protection necessary to avoid undue risk to public health and safety.
e The NRC has the authority to exercise discretion to permit continued operations--despite the existence of a noncompliance--where the noncompliance is not significant from a risk perspective and does not, in the particular circumstances, pose l
an undue risk to public health and safety. When non-compliances occur, the NRC must evaluate the degree of risk posed by that non-compliance to determine if specific l
immediate action is required. Where needed to ensure adequate protection of public health and safety, the NRC may demand immediate licensee action, up to and including 88 l
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a shutdown or cessation of licensed activities. In addition, in determining the 1
appropriate action to be taken, the NRC must evaluate the non-compliance both in terms of its direct safety and regulatory significance and by assessing whether it is part i
of a pattern of non-compliance (i.e., the degree of pervasiveness) that can lead to the j i
l determination that licensee control processes are no longer adequate to ensure 1 protection of the public health and safety. Based on the NRC's evaluation, the appropriate action could include refraining from taking any action, taking specific enforcement action, issuing orders, or providing input to other regulatory actions or assessments, such as increased oversight (e.g., increased inspection).
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- Since some requirements are more important to safety than others, the Commission should use a risk-informed approach when applying NRC resources to the oversight of 1
licensed activities (this includes enforcement). l APPENDIX B: SUPPLEMENTS - ENFORCEMENT EXAMPLES I
i I
This appendix provides examples of violations in each of four severity levels as guidance in determining the appropriate severity level for violations in each of eight activity areas (reactor operations, Part 50 facility construction, safeguards, health physics, transportation, fuel cycle and materials operations, miscellaneous matters, and emergency l
preparedness).
l 89 l
l
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 I
i provided by a licensee official. However, enforceinent action may be taken for an t
(
unintentionally incomplete or inaccurate oral statement provided to the NRC by a heensee j 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.
I 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 83
- t. *.
If significant new information is received or obtained by NRC which indicates that an enforcement sanction was incorrectly applied, consideration may be given, dependent on the circumstances, to reopening a closed enforcement action to increase or decrease the severity of a sanction or to correct the record. Reopening decisions will be made on a case-by-case basis, are expected to occur rarely, and require the specific approval of the Deputy Executive Director.
APPENDIX A: SAFETY AND CO.\1PLIANCE As commonly understood, safety means freedom from exposure to danger, or protection from harm. In a practical sense, an activity is deemed to be safe if the perceived risks are judged to be acceptable. The Atomic Energy Act of 1954, as amended, establishes
" adequate protection" as the standard of safety on which NRC regulation is based. In the context of NRC regulation, safety means avoiding undue risk or, stated another way, providing reasonable assurance of adequate protection for the public in connection with the use of source, byproduct and special nuclear materials.
The definition of compliance is much simpler. Compliance simply means meeting applicable regulatory requirements. The relationship between compliance and safety is discussed below.
- Safety is the fundamental regulatory objective, and compliance with NRC requirements 87
8
.i SUPPLEMENT I-REACTOR OPERATIONS l
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!- Violations involving for example:
- 1. A Safety Limit, as defined in 10 CFR 50.36 and the Technical Specifications being exceeded;
- 2. A system" designed to prevent or mitigate a serious safety event not being able to perform its intended safety functioniz when actually called upon to work;
- 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 r.sult of subsequent testing, receives a confirmed positive test result for drugs or alcohol.
" The term " system" as used in these supplements, includes administrative and managerial control systems, as well as physical systems.
'2
? 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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(a) In a pressurized water reactor, in the applicable modes, having one j
' high pressure safety injection pump inoperable for a period in excess of that allowed by the L action statement; or I
i 1
)
(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 l
(b) Being degraded to the extent that a detailed evaluation would be required to
- detennine 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; 92
-__________________-______-_-__-__=__-_ _ _ _ _ _ _ _ _ _ - _ _ _ - _ - - .. . _ . _ - _ _ _ - _
)
- 5. -[ Reserved]
- 6. A licensee failure to conduct adequate oversight of contractors resulting in the use of products or services that are of defective or indeterminate quality and that have safety significance;
- 7. A 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 licensed operator's confirmed positive test for dmgs 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;
- 10. The failure to meet 10 CFR 50.59 where an umeviewed safety question is involved, or a conflict with a technical specification, such that a license amendment is required; .
I
- 11. The failure to perform the required evaluation under 10 CFR 50.59 prior to 93
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implementation of the change in those situations in which no unreviewed safety question existed, but an extensive evaluation would be needed before a licensee would have had a reasonable expectation that an unreviewed safety question did not exist;
)
- 12. Programmatic failures (i.e., multiple or recurring failures) to meet the requirements of 10 CFR 50.59 and/or 50.71(e) that show a significant lack of attention to l
l detail, whether or not such failures involve an unreviewed safety question, resulting in a 1
current safety or regulatory concern about the accuracy of the FSAR or a concern that 10 CFR 50.59 requirements are not being met. Application of this example requires weighing factors such as: a) the time period over which the violations occurred and existed, b) the number of failures, c) whether one or more systems, functions, or pieces of equipment were involved and l the importance of such equipment, functions, or systems, and d) the potential significance of the failures; l 13. The failure to update the FSAR as required by 10 CFR 50.71(e) where the unupdated FSAR was used in performing a 10 CFR 50.59 evaluation and as a result, an inadequate decision was made demonstrating a significant regulatory concern; or
- 14. The failure to make a report required by 10 CFR 50.72 or 50.73 associated with l (a) an unreviewed safety question, (b) a conGict with a technical specification, or (c) any other Severity 12 vel III violation.
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D. Severity LevelIV- 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:
L (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; l
- 2. [ Reserved]
- 3. A failure to meet regulatory requirements that have more than minor safety or environmental significance;
- 4. A failure to make a required Licensee Event Report;
- 5. Relatively isolated violations of 10 CFR 50.59 not involving severity level II or III violations that do not suggest a programmatic failure to meet 10 CFR 50.59. Relatively l-isolated violations or failures would include a number of recently discovered violations that 95 l
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6 a impact on safety or licensed activities. The focus of the minor violation is not on the actual l
change, test, or experiment, but on the potential safety role of the system, equipment, etc.,
that is being changed, tested, or experimented on.
SUPPLEMENT II--PART 50 FACILITY CONSTRUCTION This supplement provides examples of violations in each of the four severity levels as l'
I guidance in determining the appropriate severity level for violations in the area of Part 50 facility construction.
l l
l A. Severity LevelI- Violations involving structures or systems that are completed'3 l
l in such a manner that they would not have satisfied their intended safety related purpose.
B. Severity LevelII- Violations involving for example:
l
- 1. A breakdown in the Quality Assurance (QA) program as exemplified by i deficiencies in construction QA related to more than one work activity (e.g., structural, _
\
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piping, electrical, foundations). These deficiencies normally involve the licensee's failure to ,
I 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 I
l " 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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. quality due to inadequate program implementation; or l
- 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 LevelIII- 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 :o make a required 10 CFR 50.55(e) report.
. D. -Severity LevelIV- 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.
98
SUPPLEMENT III--SAFEGUARDS 1
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 LevelI- 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; i
- 2. The theft, loss, or diversion of a formula quantity" of special nuclear material (SNM); or i
l " See 10 CFR 73.2 for the definition of " formula quantity."
99 o____________:_____..___________ _ _ _ . _ . .
1
- 3. Actual unauthorized production of a formula quantity of SNM B. Severity LevelII- Violations involving for example:
5
- 1. The entry of an unauthorized individual who represents a threat into a vital area 6from outside the protected area;
- 2. The theft, loss or diversion of SNM of moderate strategic significance" in which the security system did not function as required; or
- 3. Actual unauthorized production of SNM. !
I 1
C. Severity LevelIII- 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 access8 into a vital area from outside the protected
" 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.
The phrase " vital area" as used in this supplement includes vital areas and material access areas.
See 10 CFR 73.2 for the definition of "special nuclear material of moderate strategic significance."
" In determining whether access can be easily gained, factors such as predictability, identifiability, and ease of passage should be considered.
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area;
- 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; J
- 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 1
be significant while the information is outside the protected area and accessible to those not authorized access to the protected area; i
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- 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;
~/ . 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 LevelIV- 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 102 I
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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; l
- 6. A failure to properly secure or protect classified or safeguards information I 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 l unauthorized and undetected access into the protected area but which was neither easily or likely to be exploitable; i
L
- 8. A failure to conduct an adequate search at the exit from a material access area:
1
- 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 103 j I
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- 10. Other violations that have more than minor safeguards significance.
SUPPLEMENT IV-HEALTH PHYSICS (10 CFR PART 20) i l
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.
A. ~ Severity LevelI- Violations involving for example:
I
- 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. u. radiation 11posure 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;
-1
Personnel overexposure and associated violations incurred during a life-saving or other emergency response effon will be treated on a case-by-case basis.
104 J
- 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 I
20.1302(b)(2)(i); or i
- 6. Disposal of licensed material in quantities or concentrations in excess of 10 )
I times the limits of 10 CFR 20.2003.
B. Severity LevelII- 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 tem total effective dose equivalent; l
los.
- 3. A radiation exposure during any year of a minor in excess of I rem total l
effective dose equivalent: 3.0 rems to the lens of the eye, or 10 rems to the skin of the whole l
body, or to the feet, ankles, hands or forearms, or to any other organ or tissue; v
- 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 LevelIII- 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 106 l
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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 ren 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 l
the Commission under Section 20.1301(c)); I
- 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 l
Section 20.1301(c));
l 107
- 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.
108
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)-
l (except when operation up to 0.5 rem a year has been approved by the Commission under Section 20.1301(c));
1 1
- 3. A radiation dose rate in an unrestricted or controlled area in excess of 0.002 rem in any I hour (2 millirem / hour) or 50 millirems in a year;
- 4. Failure to maintain and implement radiation programs to keep radiation j exposures as low as is reasonably achievable; 1
- 5. ' Doses to a member of the public in excess of any EPA generally applicable environmental radiation standards, such as 40 CFR Part 190; 1
1
- 6. A failure to make the 30-day notification required by 10 CFR 20.2201(a)(1)(ii) or 20.2203(a);
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- 7. A failure to make a timely written report as required by 10 CFR 20.2201(b).
20.2204, or 20.22%:
- 8. A failure to report an exceedance of the dose constraint established in 10 CFR 20.1101(d) or a failure to take corrective action for an exceedance, as required by 10 CFR 20.1101(d); or
- 9. Any other matter that has more than a minor safety, health, or environmental significance.
SUPPLEMENT V - TRANSPORTATION This supplement provides examples of violations in each of the four severity levels as guidance in determining the appropriate severity level for violations in the area of NRC 2
transportation requirements ".
A. Severity Level 1 - Violations involving for example:
- 1. Failure to meet transportation requirements that resulted in loss of control of 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 require; ment 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.
110
radioactive material with a breach in package in egrity such that the material caused a radiation exposure to a member of the public and there w;ts 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 LevelII- Violations invcIving for example:
- 1. Failure to meet transportation requirements that resulted in loss of control of radioactive material with a breach in package it.tegrity 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 l
l limit; l
l l 3. External radiation levels in excess of five, but not more than 10 times the NRC l limit; or l~
- 4. A failure to make required initial notifications associated with Severity Level I i
or II violations.
1 111 l'
L L_.___-______-___-__ _ _ _ _ _ _ _
( .. . .
C. Severity LevelIII- 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; L .(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 q
i-
- 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 112
r<,
violations) that collectively reflect a potentially significant lack of attention or carelessness toward licensed responsibilities.
D. Severity LevelIV- Violations involving for example:
I
- 1. A breach of package integrity without external radiation levels exceeding the NRC limit or without contamination levels exceeding five times the NRC limits; I
- 2. Surface contamination in excess of but not more than five times the NRC limit; l
- 3. A failure to register as an aitthorized user of an NRC-Certified Transport I 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 113
)
- 7. Other violations that have more than minor safety or environmental significance.
I 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 LevelI- Violations involving for example:
- 1. Radiation levels, contamination levels, or releases that exceed 10 times the limits specified in the license; i 2. A system designed to prevent or mitigate a serious safety event not being operable when actually required to perform its design function;
- 3. A nuclear criticality accident:
- 4. A failure to follow the procedures of the quality management program, required by
'10 CFR 35.32, that results in a death or serious injury (e.g., substantial organ impairment) to
- 1. a patient; 114 L
( ' '.1 .
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- 5. A safety limit, as defined in 10 CFR 76.4, the Technical Safety Requirements, or
! the application being exceeded; or
- 6. Significant injury or loss of life due to a loss of control over licensed or certified
-activities, including chemical processes that are integral to the licensed or certified activity, whether radioactive material is released or not.
L l B. Severity Level H - Violations involving for example:
l 1. Radiation levels, contamination levels, or releases that exceed five times the l
l limits specified in the license; -
1
- 2. A system designed to prevent or mitigate a serious safety event being inoperable; I
l l
' 3. A substantial programmatic failure in the implementation of the quality management l program required by 10 CFR 35.32 that results in a misadministration; i- 1 l
- 4. A failure to establish, implement, or maintain all criticality controls (or control l systems) for a single nuclear criticality scenario when a critical mass of fissile material was i
present or reasonably available, such that a nuclear criticality accident was possible; or i
!!5 l
e
- ~
- 5. The potential for a significant injury or loss of life due to a loss of control over licensed or certified activities, including chemical processes that are integral to the licensed or certified activity, whether radioactive material is released or not (e.g., movement of liquid UF6 cylinder by unapproved methods).
C. Severity LevelIII- Violations involving for example:
- 1. A failure to control access to licensed materials for radiation protection purposes as specified by NRC requirements;
- 2. - Possession or use of unauthorized equipment or materials in the conduct of licensee activities which degrades safety;
- 3. Use of radioactive material on humans where such use is not authorized; f
- 4. Conduct of licensed activities by a technically unqualified or uncertified person:
- 5. A substantial potential for exposures, radiation levels,' contamination levels, or releases, including releases of toxic material caused by a failure to comply with NRC regulations, from licensed or certified activities in excess of regulatory limits; 116
- 6. Substantial failure to implement the quality management program as required by 10 CFR 35.32 that does not result in a misadministration; failure to report a misadministration; or programmatic weakness in the implementation of the quality management program that results in a misadministration;
- 7. A 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 at least two qualified individuals or to use radiographic equipment, radiation survey instruments, and/or personnel monitoring devices as required by 10 CFR Part 34;
- 9. A failure to submit an NRC Form 241 as required by 10 CFR 150.20; i
- 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 I
licensed material is being stored where the new facilities do not meet the safety guidelines; or a change in the quantity or type of radioactive material being processed or used that has I
117 1
,. ,. 5 radiological significance;
- 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 corsduct and/or complete decommissioning activities in accordance with regulation or license condition, or failure to meet required schedules without adequate justification;
' 12. A significant failure to comply with the action statement for a Technical Safety Requirement Limiting Condition for Operation where the appropriate action was not taken within the required time, such as:
(a) In an autoclave, where a containment isolation valve is inoperable for a period in excess of that allowed by the action statement: or (b) Cranes or other lifting devices engaged in the movement of cylinders having inoperable safety components, such as redundant braking systems, or other safety devices for a .
period in excess of that allowed by the action statement;
- 13. 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.,
118 l
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i ., .,
safety system not operable unless utilities available, materials or components not according to specifications); or (b) Being degraded to the extent that a detailed evaluation would be required to determine its operability;
- 14. Changes in parameters that cause unanticipated reductions in margins of safety; i
l
- 15. A significant failure to meet the requirements of 10 CFR 76.68, including a failure l l
such that a required certificate amendment was not sought; i
- 16. A failure of the certificate holder to conduct adequate oversight of contractors 1
resulting in the use of products or services that are of defective or indeterminate quality and that have safety significance;
- 17. Equipment failures caused by inadequate or improper maintenance that i
substantially complicates recovery from a plant transient; I l
- 18. A failure to establish, maintain, or implement all but one criticality control (or l
control systems) for a single nuclear criticality scenario when a critical mass of fissile material was present or reasonably available, such that a nuclear criticality accident was possible; or h
119
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- 19. A failure, during radiographic operations, to stop work after a pocket dosimeter is found to have gone off-scale, or after an electronic dosimeter reads greater than 200 mrem.
and before a determination is made of the individual's actual radiation exposure.
D. Severity LevelIV- Violations involving for example:
- 1. A failure to maintain patients hospitalized who have cobalt-60, cesium-137, or iridium-192 implants or to conduct required leakage or contamination tests, or to use properly calibrated equipment;
- 2. Other violations that have more than minor safety or environmental significance;
- 3. Failure to follow the quality management (QM) program, including procedures, whether or not a misadministration occurs, provided the failures are isolated, do not demonstrate a programmatic weakness in the implementation of the QM program, and have limited consequences if a misadministration is involved; failure to conduct the required program review; or failure to take corrective actions as required by 10 CFR 35.32;
- 4. A failure to keep the records required by 10 CFR 35.32 or 35.33; 5.' A less significant failure to comply with the Action Statement for a Technical Safety Requirement Limiting Condition for Operation when the appropriate action was not taken 120
>., .y, within the required time; 1
1
- 6. A failure to meet the requirements of 10 CFR 76.68 that does not result in a Severity Level I, II, or III violation;
- 7. A failure to make a required written event report, as req:' ired by 10 CFR ,
1 76.120(d)(2); or
- 8. A failure to establish, implement, or maintain a criticality control (or control system) for a single nuclear criticality scenario when the amount of fissile material available was not, but could have been sufficient to result in a nuclear criticality.
SUPPLEMENT VII-MISCELLANEOUS MATTERS This supplement provides examples of violations in each of the four severity levels as guidance in determining the appropriate severity level for violations involving miscellaneous matters.
A. Severity LevelI- Violations involving for example:
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- 1. Inaccurate or incomplete information2 : that is provided to the NRC (a) deliberately with the knowledge of a licensee official that the mformation 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;
- 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 regulatcry action such as an immediate order required by public health arid safety considerations;
- 3. Information that the licensee has identified'as having significant implications for pubiic 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 cr similar regulations against an employee;
- 5. A knowing and intentional failu'e to provide the notice required by 10 CFR Part 2' 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.
122 i
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? 21; or i 1
! 6. A failure to substantially implement the required fitness-for-duty program.22
- B. Severity Level # - Violations involving for example:
l l
- 1. Inaccurate or incomplete information that is provided to the NRC (a) by a 1
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
(. regubtory position;-
- 2. Incomplete or inaccurate information that the NRC requires be kept by a L ' 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; 22 The example for violations for fitness-for-duty relate to violations of 10 CFR Pan 26.
123 p
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'4.~ An action by plant management or mid-leve) management in violation of 10 CFR 50.7 or similar regulations against an employee;
-5. _ A failure to provide the notice required by 10 CFR Part 21; f
- 6. A failure to remove an individual from unescorted access who has been involved in the sale, use, or possession of illegal dmgs 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 LevelIII- Violations involving for example:
124
I o., ..
l \
l l 1. Incomplete or inaccurate information that is provided to the NRC (a) because of 1
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 thzt 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 I resulted in a reconsideration of a regulatory position or substantial further inquiry such as an additional inspection or a formal request for information; i
l 1
- 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; I
- 4. An action by first-line supervision or other low-level management in violation t
l of 10 CFR 50.7 or similar regulations against an employee; i
- 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; 125 l
. ,t
- 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 11 violation:
- 8. A failure to assure, as required, that contractors have an effective fitness-for-duty program; I
- 9. A break.down 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 meeting the objectives of 10 CFR 26.10; or i
- 10. Threats of discrimination or restrictive agreements which are violations under !
NRC regulations se:h as 10 CFR 50.7(f).
D. Severity LevelIV- Violations involving for example:
- 1. Incomplete or inaccurate information of more than minor significance that is 126 l
L .. . .. . . ..
a
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 I significance;
- 4. Violations of the requirements of Part 26 of more than minor significance; i
?
I
! 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 l
Categorization.
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e ' . '. ;'
SUPPLE 31ENT VIII~ESIERGENCY 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 healdi and safety, or (iii) poor self critiques of the licensee's exercises, enforcement action may be appropriate.
A. Severity LevelI- Violations involving for example:
In a general emere.ency, 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, activete emergency response facilities, and augment shift staff.)
B. Severity Level # - 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) 128 a
I ,, .,.
respond to the event (e.g., assess actual or potential offsite consequences, activate emergency response facilities, and augment shift staff); or
- 2. A licensee failure to meet or implement more than one emergency planning standard involving assessment or notification.
C. Severity LevelIII- Violations involving for example:
- 1. In an alert, licensee failure to promptly (1) correctly classify the event, (2) make iequired 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 one emergency planning standard involving assessment or notification; or l 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.
129
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-D. Severity LevelIV- 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 day of May,1998.
For the Nuclear Regulatory Commission. l
/
Jol9 .CHoyle, / l Secretary of the Commission. j l
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CONGRESSIONAL CORRESPOND 5YG SYSTEM DOCUMENT PREPARATION GECKLIST This check list is to be submitted with each document (or group of Qs/As) sentfor proces into the CC5'.
- 1. BRIEFDESCRIPT7ON OFDOCUMENT(S) ,
- n. (L
- 2. TYPE OFDOCUMENT X CORRESPONDING RE4 RINGS (Qs/As)
- 3. DOCUMENT CONDlOL _ SENSITIVE (NRC ONLY) X NON. SENSITIVE
- 4. CONGRESSIONAL COMMIT 1EE AND SUBCOMMITTEE ((fapplicable)
Congressional Comminee Subcommittee 5, SUBJECT CODES l
i (A) l (B) l (C)
- 6. SOURG OFDOCUMEVTS (A) 5520 (DOCUMEVT NAME )
,(B) SC4N (C) ATTAGMEVIS (D) OTHER
\
LOG DA7E5' >
- 7. SQ) IeI7UM9 DATA OC4 SENTDOCUMENT TO CCS (A
n ,
- (B) DATE CCS RECE7VED DOCUMLVT (C) _
DATE RETURNED TO OC4 FOR ADDITIONAL INFORMATION l (D) DATE RESUBMITTED BY OC4 TO CCS (E) DATE EN7ERED INTO CC5' BY
! (F) DATE OC4 NOTIFIED THATDOCUMENT15IN CCS C0 u u E Nis: KDC?S RELEASE TO PDR I
J