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DoE Handbook: Enforcment of Nuclear Safety Requirm
DOE HANDBOOK
NOT MEASUREMENT SENSITIVE
DOE-HDBK-1087-95
JUNE 1995
DOE HANDBOOK
DOE ENFORCEMENT OF NUCLEAR SAFETY REQUIREMENTS
U.S. Department of Energy
Washington, D.C. 20585 AREA MISC
DISTRIBUTION STATEMENT A. Approved for public release;
distribution is unlimited.
------------------------------------------------------------------------
FOREWORD
The purpose of the DOE Enforcement Program is to promote and
protect the radiological health and safety of the public and workers
at DOE facilities by:
a. Fostering compliance with applicable DOE nuclear safety
requirements;
b. Providing positive incentives for contractors, subcontractors and
suppliers who perform the following tasks:
1.Timely self-identification of nuclear safety deficiencies,
2.Prompt and complete reporting of such deficiencies to DOE,
3.Root cause analyses of nuclear safety deficiencies,
4.Prompt correction of nuclear safety deficiencies in a manner
which precludes recurrence, and
5.Identification of modifications in practices or facilities that can
improve public or worker radiological health and safety.
c. Deterring future violations of DOE nuclear safety requirements
by DOE contractors; and,
d. Encouraging the continuous overall improvement of operations
at DOE nuclear facilities.
------------------------------------------------------------------------
TABLE OF CONTENTS
FOREWORD
CHAPTER 1 - GENERAL
1.1. Purpose of the Handbook
1.2. Uses of the Handbook
1.3. Interim Enforcement Guidance
1.4. Definitions
CHAPTER 2 - RESPONSIBILITIES AND AUTHORITIES
2.1. Scope of the Chapter
2.2. Assistant Secretary, Environment Safety and Health
2.3. Director, Enforcement and Investigation Staff
2.4. Enforcement and Investigation Staff
2.5. Secretarial Notification and Consultation
CHAPTER 3 - EVALUATION AND INVESTIGATION OF
POTENTIAL VIOLATIONS, AND CONDUCT OF
ENFORCEMENT CONFERENCES
3.1. Scope of the Chapter
3.2. General Overview of Enforcement Process
3.3. Identification of Nuclear Safety Noncompliances
3.4. Evaluation of Noncompliances
3.5. Investigation of Potential Violations
3.6. Informal EnforcementConferences
CHAPTER 4 - ENFORCEMENT ACTIONS
4.1. Preliminary and Final Notices of Violation
4.2. Severity Level 29
4.3. Base Civil Penalties
4.4. Adjustment of Base Civil Penalty
4.5. Administrative Matters
CHAPTER 5 - ADDITIONAL ENFORCEMENT POLICY
GUIDANCE
5.1. Notices of Violation for Suppliers and Subcontractors
5.2. Department of Justice (DOJ) Referrals
5.3. Discrimination for Engaging in Protected Activities
5.4. Accuracy of Information
5.5. Willful Violations
APPENDIX A - NONCOMPLIANCE REVIEW FORM
APPENDIX B - CHECKLIST FOR PREPARATION OF
ENFORCEMENT ACTIONS
APPENDIX C - SUGGESTED FORMATS FOR
ENFORCEMENT ACTIONS
APPENDIX D - 10 CFR PART 820 ENFORCEMENT POLICY
Key to Format Notation
FORM 1: Cover letter for Enforcement Action Without a Civil
Penalty
FORM 2: PNOV* (for all violations without a civil penalty)
Preliminary Notice of Violation
FORM 3: Cover Letter for Enforcement Action with Civil Penalty
FORM 4: Preliminary Notice with all Violations Assessed a
Civil Penalty
FORM 5: Preliminary Notice with some Violations Assessed a
Civil
Penalty and some Violation
FORM 6: Cover Letter for Order Imposing Civil Monetary Penalty
FORM 7: Order Imposing Civil Monetary Penalty
------------------------------------------------------------------------
CHAPTER 1 - GENERAL
1.1. Purpose of the Handbook
This Handbook provides detailed guidance and procedures to
implement the General Statement of DOE Enforcement Policy
(Enforcement Policy or Policy), described in 10 CFR 820
Appendix A 58FR 43680 (August 17, 1993). A copy of this
Enforcement Policy is included for ready reference in Appendix D.
The guidance provided in this Handbook is qualified, however, by
the admonishment to exercise discretion in determining the proper
disposition of each potential enforcement action. As discussed in
subsequent chapters, the Enforcement and Investigation Staff will
apply a number of factors in assessing each potential enforcement
situation. Enforcement sanctions are imposed in accordance with
the Enforcement Policy for the purpose of promoting public and
worker health and safety in the performance of activities at DOE
facilities by DOE contractors (and their subcontractors and
suppliers) who are indemnified under the Price-Anderson
Amendments Act, 42 U.S.C. 2210(d) (PAAA). These indemnified
contractors, and their suppliers and subcontractors, will be referred
to in this Handbook collectively as "DOE contractors." It should be
remembered that the purpose of the Department's enforcement
policy is to improve nuclear safety for our workers and the public,
and this goal should be the prime consideration in exercising
enforcement discretion.
1.2. Uses of the Handbook
a. This Handbook is administered by the Enforcement and
Investigation Staff currently located in the Office of Environment,
Safety and Health. The Enforcement and Investigation Staff has
responsibility for enforcing nuclear safety requirements at
applicable DOE facilities and has also been assigned enforcement
adjudication responsibility under 10 CFR Part 820, Subpart B.
Further, the Enforcement and Investigation Staff has criminal
referral responsibilities pursuant to the PAAA, as described in
Section 1.2(d) below.
b. This Handbook outlines the authority and responsibilities
assigned to the Enforcement and Investigation Staff, the Office of
Environment, Safety and Health. The Assistant Secretary for
Environment, Safety and Health implements DOE's statutory
enforcement program (Section 17 of the Price-Anderson
Amendments Act of 1988 (PAAA) which authorizes citations and
civil monetary penalties for violations of DOE nuclear safety
regulations). The Director, Enforcement and Investigation Staff, has
been delegated the authority to issue Notices of Violation and
recommend proposed civil penalties (10 CFR 820.24,.25) for
PAAA violations. Before issuing Notices of Violation, the Director
will obtain signatures of other DOE officials as necessary.
c. The Enforcement Program described in this Handbook is
applicable to DOE contractors for violations of nuclear safety
requirements under the authority of PAAA.
d. Section 18 of the PAAA (42 U.S.C. 2273©) also makes DOE
contractors subject to criminal penalties for knowing and willful
violations of applicable DOE nuclear safety rules, regulations and
orders. Since suspected criminal violations are referred to the
Department of Justice (DOJ) for appropriate action, this Handbook
addresses only civil matters. Referrals to DOJ do not preclude DOE
from taking civil enforcement actions, appropriately coordinated
with DOJ.
e. PAAA is applicable to all indemnified DOE contractors;
however, provisions for civil penalties do not apply to DOE
contractors currently operating the following DOE National
Laboratory sites:
Argonne Los Alamos Lawrence Livermore Lawrence Berkeley
Fermi Princeton Plasma Physics Brookhaven Pacific Northwest
It should be noted that these contractors are not exempt from
citations (i.e., Notices of Violation) or criminal penalties. All other
nonprofit educational institutions that are DOE contractors have
automatic remission of civil penalties but are also not exempt from
citations or criminal penalties.
f. This Handbook uses both mandatory and permissive terms.
Mandatory terms (e.g., "shall") require specific actions or decisions
in the enforcement process consistent with the guidance in this
Handbook. Permissive terms (e.g., "should") recognize the
flexibility needed in the enforcement process. Terms such as
"should" and "normally" establish the normal or expected course of
action. To provide the necessary oversight and agency wide
consistency, exceptions to the mandatory guidance and procedures
in this Handbook may be authorized only by the Director,
Enforcement and Investigation Staff.
g. DOE will exercise appropriate discretion in determining the
disposition of any potential enforcement action, which may vary
from the guidance and procedures in this Handbook. It should be
recognized that the guidance and procedures contained in this
Handbook are internal to DOE only. Therefore, the failure to
follow the guidance and procedures in this Enforcement Handbook
is not a basis to invalidate an enforcement action.
h. In general, all records and correspondence related to a pending
enforcement action prior to the issuance of a Preliminary Notice of
Violation (PNOV) are considered "predecisional" and shall be
clearly labeled "Predecisional - Not for Public Disclosure."
1.3. Interim Enforcement Guidance
From time to time, enforcement issues will arise that will require
the Enforcement and Investigation Staff to issue guidance to clarify
the guidance and procedures set forth in this Handbook. The
Director, Enforcement and Investigation Staff, will endeavor to
provide such guidance in a timely manner, and assure its wide
distribution. Such supplemental guidance will generally be
forwarded to PAAA Coordinators at each site.
1.4. Definitions (See also 10 CFR 820.2)
a. Contractor - Any person or entity under indemnification with
DOE with the responsibility to perform activities in connection
with any DOE facility, laboratory, or program subject to nuclear
safety requirements. As used in this Handbook, reference to a
contractor also includes its subcontractors or suppliers.
b. Director, Enforcement and Investigation Staff - Director,
Enforcement and Investigation Staff, refers to the Director of the
Enforcement and Investigation Staff in the Office of Environment,
Safety and Health.
c. EH-1 - EH-1 refers to the Assistant Secretary for Environment,
Safety and Health.
d. Enforcement Adjudication - The adjudication process and
procedures are set forth in 10 CFR Part 820, Subpart B. Includes
adjudication of contested violations issued pursuant to the PAAA.
e. Excluded Facility or Activity - A facility or activity that is not
subject to a DOE nuclear safety requirement as a result of
exclusionary provisions in a substantive rule. This category may
also include facilities or activities that do not meet an enforcement
threshold that would make it appropriate for an enforcement action.
f. Exemption - Relief, waiver, or release from DOE nuclear safety
requirements, either temporary or permanent, as granted by the
responsible Secretarial Officer pursuant to the provisions of 10
CFR Part 820, Subpart E.
g. Price-Anderson Noncompliance (Violation) - The term
noncompliance and violation are essentially interchangeable in that
both terms connote a failure to comply with an applicable nuclear
safety requirement. Noncompliances having the requisite safety
significance will be subject to Notices of Violation and, if
appropriate, civil penalties. Isolated minor noncompliances
involving minimal or low safety significance will be tracked by the
contractor and are subject to periodic review.
h. Nuclear Safety Requirements - Legally binding obligations
which are set forth in applicable statutes, DOE regulations, and
PAAA Compliance Orders, that govern specific nuclear activities
and are subject to PAAA enforcement actions. DOE facilities and
activities subject to DOE nuclear safety requirements may be
subject to other requirements set forth in orders, notices, standards,
safety guides, and Handbooks of "good practice." These other
requirements are not enforceable through PAAA provisions. These
other requirements may also be referred to elsewhere as "nuclear
safety requirements" if they are related to nuclear activities, and,
thus, care should be exercised as appropriate to differentiate the
statutorily mandated PAAA enforceable requirements from other
requirements.
i. PAAA Adjudication - The adjudication process and procedures
set forth in 10 CFR Part 820, Subpart B. May also be defined as an
enforcement adjudication.
j. Cognizant Secretarial Officers (CSOs) - The heads of DOE
offices with responsibility for specific DOE facilities. These
include the Assistant Secretaries, Environmental Restoration and
Waste Management (EM), and Defense Programs (DP), and the
Directors of Energy Research (ER), and Civilian Radioactive
Waste Management (RW).
k. Secretarial Officer (SO) - The head of a Secretarial Office such
as the Assistant Secretary for Environment, Health, and Safety or a
CSO as defined above.
l. Similar Violation - A violation that reasonably could have been
prevented by a contractor's implementation of corrective action for
a previous violation.
m. System - As used in this Handbook, includes systems of
administrative and managerial controls, as well as physical systems.
n. Willfulness - An attitude toward compliance with DOE nuclear
safety requirements that ranges from deliberate intent to violate
regulatory requirements or conduct that is so egregious that it
constitutes a reckless disregard for a requirement. (Willfulness
does not include acts that do not rise to the level of ordinary
carelessness, for example, inadvertent clerical errors.)
------------------------------------------------------------------------
CHAPTER 2 - RESPONSIBILITIES AND AUTHORITIES
2.1. Scope of the Chapter
This chapter summarizes the responsibilities and authorities for
enforcement activities established in the DOE Enforcement
Program Procedural Rules (10 CFR 820) and the Enforcement
Policy (10 CFR Part 820, Appendix A). Further detail on
supporting roles to the Office of Enforcement and Investigation
Staff is contained in a separate DOE Handbook, titled DOE
Enforcement Program - Roles and Responsibilities.
2.2. Assistant Secretary, Environment, Safety and Health
The Office of the Assistant Secretary, Environment, Safety and
Health DOE, has been assigned the responsibility by the Secretary
of Energy to implement the enforcement authority provided to the
Department in the PAAA. The Assistant Secretary, has the
responsibility to provide personnel and resources for PAAA
enforcement activities, except for those which are the specific
responsibility of the Deputy Assistant Secretary for Naval Reactors
as set forth in 10 CFR Part 820.
2.3. Director, Enforcement and Investigation Staff
The Director, Enforcement and Investigation Staff, has been
designated principal officer for DOE enforcement activities for the
PAAA. The Director manages all DOE enforcement activities
pursuant to these statutes and delegations; directs the technical and
legal reviews; supervises investigations; prepares enforcement
actions; is responsible for the administrative litigation of contested
enforcement actions, the issuance of Consent Orders to resolve
contested issues, and the appropriate referral of criminal
enforcement actions to DOJ. The Director obtains signatures of
other DOE officials as necessary before issuing Notices of
Violation. The Director is also responsible for providing guidance
and training for implementation of Department's PAAA
Enforcement Programs.
2.4. Enforcement and Investigation Staff
As directed by the Director, The Enforcement and Investigation
Staff, performs the following tasks; among other things:
a. Reviews and evaluates available information on noncompliances
and potential violations, including, information reported to the
Noncompliance Tracking System. Completes the Noncompliance
Review Form and recommends whether to conduct an investigation
or initiate enforcement actions to the Director, Enforcement and
Investigation Staff.
b. Investigates potential violations of nuclear safety requirements as
identified by internal or external sources, and prepares investigative
reports and/or technical evaluations with appropriate findings and
recommendations up to and including the recommendation of
enforcement actions. These investigations are conducted in
accordance with the DOE Investigation Handbook.
c. Prepares for the Director's signature, all recommended
enforcement actions, including PNOV's, FNOV's, civil penalties
and appropriate transmittal letters to the contractor.
d. Prepares an advance notification to the Secretary for all
enforcement actions involving a civil penalty.
e. Chairs and participates in enforcement conferences as directed
by the Director, consistent with the guidance in this Handbook.
g. Prosecutes contested enforcement actions consistent with the
procedures set forth in 10 CFR Part 820, Subpart B, as directed by
the Director.
h. Resolves contested issues and actions through settlement
between and among the parties and prepares Consent Orders for
issuance by the Director.
i. Periodically issues a DOE Report entitled "Resolution of DOE
Enforcement Actions Taken Against Contractors, Subcontractors,
and Suppliers."
j. Maintains the Noncompliance Tracking System (NTS).
k. Maintains a docket for (1) enforcement actions commencing with
the filing of a PNOV; (2) interpretations issued pursuant to 10
CFR 820, Subpart D (interpretations of nuclear safety regulatory
requirements issued by the Office of General Counsel); and (3)
exemptions to nuclear safety requirements issued pursuant to 10
CFR 820, Subpart E. Docketing functions will be performed by the
Office of Docketing Clerk.
l. Maintains files for implementation plans developed pursuant to
the Rules, exception decisions and legal interpretations of the
General Counsel's Office.
2.5. Secretarial Notification and Consultation
For all enforcement actions involving proposed civil penalties (See
Section XI of the Enforcement Policy), the Secretary will be
notified in advance of service of an enforcement notification (EN).
In addition, consultation with the Secretary is required before
enforcement action is taken in any of the following cases:
1.Any proposed enforcement action where civil penalties in the
aggregate are equal to or greater than $100,000.
2.Any proposed enforcement action that involves a Severity Level I
violation.
3.Any enforcement action that the Assistant Secretary, EH-1,
concludes warrants the Secretary's involvement.
4.Any proposed enforcement action on which the Secretary asks to
be consulted.
------------------------------------------------------------------------
CHAPTER 3 - EVALUATION AND INVESTIGATION OF
POTENTIAL VIOLATIONS, AND CONDUCT OF
ENFORCEMENT CONFERENCES
3.1. Scope of the Chapter
This chapter provides guidance on the evaluation and investigation
of potential violations, and the use of enforcement conferences.
Guidance on preparation of enforcement actions is provided in
Chapter 4.
3.2. General Overview of Enforcement Process
The steps in the enforcement process are outlined below. Although
it is important to issue enforcement actions as promptly as possible,
there may be circumstances in which the magnitude and/or
complexity of a matter and the need for thoroughness may
unavoidably delay the conclusion of an investigation. Consistent
with DOE policy that encourages settlement of enforcement
proceedings at any time, the Director, Enforcement and
Investigation Staff, and the contractor can meet at any stage of the
process and reach a settlement. Such a settlement would be set
forth in a Consent Order (Ref. 10 CFR 820.23). If the Consent
Order is signed before the commencement of an enforcement
adjudication, it is final upon signature by the affected parties and
the Director, Enforcement and Investigation Staff. If a Consent
Order is signed after commencement of an enforcement
adjudication, it will be final upon completion of the processes set
forth in 10 CFR 820.23.
Enforcement Process Steps
1.Evaluate potential noncompliances reported in the
Noncompliance Tracking System or identified by other sources,
and complete Noncompliance Review Form to document
evaluation.
2.Determine whether to initiate an investigation based on results of
NTS Report evaluation, considering safety significance and other
related factors.
3.Conduct investigation of a potential or alleged violation and
prepare investigation report.
4.Determine whether there is a specific violation and, if so, identify
the specific violation.
5.Decide whether or not to proceed after an assessment of
investigation findings on safety significance, related factors,
severity level and potential civil penalty as appropriate.
6.Conduct enforcement conference initiated by the Director,
Enforcement and Investigation Staff, or upon request by contractor
against whom the enforcement action is being considered.
7.Reevaluate whether the matter constitutes a noncompliance which
merits preparation of an enforcement action.
8.Where warranted, the Director, Enforcement and Investigation
Staff, recommends issuance of a PNOV, with or without civil
penalty. Other proposed remedies may be set forth to correct the
violation.
9.The contractor responds in writing within 30 days and may
contest the notice with substantive evidence, contest the civil
penalty, if applicable, or waive the right to contest.
10.The Director, Enforcement and Investigation Staff, recommends
a determination on the matter, based on the entire evidence of
record. As applicable, this includes issuance of a Final Notice of
Violation (FNOV), civil penalty and other remedies to correct the
violation.
11.An FNOV (without a civil penalty) becomes a Final Order 15
days after service, unless modified by an order from the Secretary.
FNOV's with a civil penalty become a Final Order if the contractor
does not contest the Notice of within 30 days, and agrees to pay the
civil penalty and perform the other remedies set forth in the FNOV.
12.The contractor may request an on-the-record adjudication of an
FNOV and civil penalty. This request will initiate a PAAA
adjudication with an Administrative Law Judge appointed by the
Secretary to serve as presiding officer. Alternatively an action can
be commenced in Federal District Court. Responsibility for
prosecuting matters in Federal District will be coordinated with the
DOE General counsel and DOJ. (The PAAA adjudication process
is set forth in 10 CFR Part 820, Subpart B, and will not be
discussed further in this Handbook)
3.3. Identification of Nuclear Safety Noncompliances
Conditions that are not in compliance with nuclear safety
requirements may be identified through various activities and
sources, including the following:
Information reported by contractors, in DOE's Noncompliance
Tracking System;
Formal inspections or assessments by the contractors, DOE Field
Offices, or Environment, Safety and Health
Reports from DOE field personnel and EH site representatives;
Information provided by the DOE Office of Inspector General or
the Office of Contractor Employee Protection;
Allegations communicated to DOE from outside the organization;
Media reports of nuclear facility activities;
Congressional inquiries;
Defense Nuclear Facilities Safety Board (DNFSB) inquiries or
reports; and,
Information from other agencies, including the Nuclear Regulatory
Commission, Department of Labor, Department of Transportation
or state and local officials.
It is anticipated that the primary source of such information will be
the contractors themselves since 10 CFR Part 820, Appendix A
provides positive incentives for the prompt identification and
reporting of all potential nuclear safety violations. The primary
vehicle that will be used by contractors is the Noncompliance
Tracking System that is maintained by DOE. Guidance on
contractor self-tracking and reporting through NTS is provided in a
separate DOE Handbook, Identification, Reporting and Tracking of
Nuclear Safety Noncompliances. That Handbook also provides
guidance for a contractor self-tracking process and the use of
threshold guidance for only reporting the most safety significant
noncompliances into the NTS system if a contractor implements an
appropriate self-tracking process.
The preferred path is for the contractor to report potential
noncompliances into the NTS. Thus, if DOE or another external
entity identifies a noncompliance condition, the preferred process
would be for that entity to notify the contractor so that it could
report the noncompliance into the NTS. The contractor reporting
into NTS will include a summary of the noncompliance, duration
since occurrence, corrective actions, and other information related
to the noncompliance to support DOE's review to make an initial
determination of safety significance. Guidance on DOE's review of
contractor's NTS reports is provided in the following section.
Matters that constitute a significant regulatory concern and could
involve high or potential impact on the public or workers are
categorized as severity level I or II violations. Severity level III
violations involve events or activities that have the potential to
result in localized impact on workers or the environment. They are
less serious, but of more than a minor nature. They will be
monitored to determine whether, in aggregate in discrete areas, they
could lead to more serious problems. In such circumstances, they
will be escalated for enforcement purposes. When a category I, II or
III violation has occurred, the contractor will be required to respond
within 45 days of the occurrence, describing any corrective actions
taken to prevent recurrence and stating the date by which the
corrective action will be complete.
It should be noted that although the following sections refer to the
identification, documentation, and significance of violations, the
use of the term "violation" in the context of these sections refers to
"potential violations" of DOE nuclear safety rules or other PAAA
enforceable nuclear safety requirements. The term noncompliance
and violation are essentially interchangeable in that both terms
connote a failure to comply with an applicable nuclear safety
requirement. In general DOE will use the term "noncompliance" for
those matters in which the contractor has identified a condition that
does not comply with nuclear safety requirements. Noncompliances
having the requisite safety significance, as determined by DOE,
will be subject to Notices of Violation, and if appropriate, civil
penalties. Isolated minor noncompliances involving minimal or low
safety significance will not be subject to enforcement actions but
will be subject to periodic review, such as to identify recurring
noncompliances.
3.4. Evaluation of Noncompliances
DOE's Enforcement and Investigation Staff is responsible for
reviewing noncompliance reports for consideration of more
comprehensive investigation and potential enforcement action. The
objectives of the review follow:
1.Review of the facts contained in the available information to
confirm that a DOE nuclear safety requirement has actually been
violated.
2.Evaluate the safety significance of the noncompliance to
determine if a more comprehensive investigation is warranted.
This evaluation is to be performed for NTS and other reports that
are above the minimum thresholds established in DOE Handbook
Identification, Reporting and Tracking of Nuclear Safety
Noncompliances. For those reports above the threshold, and other
noncompliance conditions that are judged to be potentially safety
significant, DOE will perform an evaluation using the
"Noncompliance Review Form" in Appendix A to this Handbook.
The evaluation and preparation of the "Noncompliance Review
Form" will be performed by the Enforcement and Investigation
Staff, and recommendations reviewed and approved by the Director,
Enforcement and Investigation Staff.
Where the evaluation concludes that a more comprehensive
investigation is required for consideration of enforcement action,
an investigation would be initiated by the Enforcement and
Investigation Staff. Guidance for this investigation is contained in
the following section.
3.5. Investigation of Potential Violations
3.5.1. Investigation of Circumstances of the Noncompliance
Once a violation that warrants investigation has been identified, the
facts surrounding the matter must be investigated and assembled.
The information documented should be specific regarding times,
dates, titles of persons, and the structures, systems and components
involved in the violation. The investigation documentation should
contain a detailed discussion of the findings to substantiate any
health and safety issues and violations of nuclear safety
requirements subject to DOE enforcement actions. In most matters,
there may be need to supplement information initially received from
others. In order to develop the appropriate enforcement action,
information for each violation (or group of violations) should be
documented to address the following questions, as applicable and
appropriate, considering the significance and complexity of the
violation(s) and available resources:
a. What DOE nuclear safety requirement was violated?
b. How was the requirement violated?
c. When was the requirement violated and what was the duration of
the violation?
d. Who violated the requirement?
e. How and by whom (contractor, DOE or other) was the violation
discovered?
f. Was the violation required to be reported by the contractor and, if
so, what was the applicable reporting requirement?
g. Was the violation reported by the contractor and, if so, when and
by whom was it reported?
h. If the violation was reported by the contractor, but the report was
not timely, why was the report not timely?
i. Was the report complete and accurate?
j. What was the apparent root cause and contributing causal factors
for the violation? Did the contractor aggressively pursue this
information?
k. Were there multiple examples of a particular violation?
l. Is the evidence indicative of programmatic problems or is it an
isolated case?
m. Was the contractor's management aware or should it have been
aware of the violation?
n. What were the opportunities and when did they exist for the
contractor's staff and management to be aware of the violation?
o. Is there evidence that any level of the contractor's management
was involved directly or indirectly in the violation and to what
extent?
p. What were the circumstances surrounding the violation, such as
system configuration and operational conditions, which would
affect its significance?
q. Are there other circumstances surrounding the violation which
increase or decrease its significance?
r. What short-term corrective and remedial action was taken by the
contractor and when was it taken?
s. Did DOE have to intervene to accomplish satisfactory short-term
correction and remedial action?
t. Did the contractor aggressively pursue long-term remedies with
the department including proper scheduling and funding of such
remedies?
u. Were there previous, similar DOE or contractor inspection,
assessment, or audit findings and, if so, should the corrective
actions from those findings have prevented this violation?
v. Was the noncompliance condition identified in any
implementation plan for the affected facility or for any facility at
the site (i.e., a close-out or process control failure)?
w. Did any action (or failure to act) by DOE contribute to this
violation?
3.5.2. Consideration of Safety Significance
Once the circumstances surrounding a violation are understood and
documented, the significance and the commensurate severity level
should be determined as part of the investigation. The following
provide several factors to be considered in a determination of safety
significance and severity level.
If an Immediate Hazard to Workers or the Public:
If facility workers, the public or the environment are likely to be
endangered by the continuation of the conditions created by the
violation, or if there is a lack of reasonable assurance that activities
will be properly conducted, the responsible CSO or other
appropriate official should initiate immediate action to correct the
condition and promptly discuss with the Director, Enforcement and
Investigation Staff, as appropriate, the need for an immediately
effective order or other formal directive such as a Compliance
Order issued by the Secretary. In these instances 10 CFR Part 820,
Subpart C provides that the action may be taken before issuing an
investigation report or holding an enforcement conference.
Violations of conditions in Compliance Orders may subject the
contractor to a separate enforcement action or may increase the
severity of enforcement action associated with the underlying
noncompliance condition.
Factors Affecting Safety Significance:
In determining the safety significance of a violation, the evaluation
should consider the potential hazard to workers inside and outside
the facility, to the public and to the environment. In addition, the
managerial policies and practices that may represent contributing
factors should be considered. Consideration should be given to the
matter as a whole in light of the circumstances surrounding the
violation. There may be cases in which the hazard is low, but the
failures of management are significant in light of the circumstances
surrounding the violation and, therefore, the severity level should
be based on the management failure(s) and not simply the apparent
hazard. The following factors should also be considered:
a. Did the violation actually or potentially have an impact on health
and safety? A violation that involves no actual threat but which had
the potential to have an impact on health and safety may be very
significant, depending upon the risk of the potential threat, i.e., its
likelihood,and the possible consequences involved.
b. What was the root cause of the violation? Was it caused by
training deficiencies? Failure to follow procedures? Inadequate
procedures? Failure to properly follow-up on activities or
commitments? These broader programmatic weaknesses may have
more significance than the particular hardware or equipment
affected by the violation.
c. Is the violation an isolated incident or were there multiple
examples of similar violations in the same time frame? Is it
indicative of a management or programmatic breakdown?
Management or programmatic breakdowns may be more severe than
an isolated incident.
d. Was management aware of or involved in the violation and, if it
was involved, at what level of management, and to what extent?
Violations in which management was directly involved, in general,
are more significant han those of which management was unaware.
Violations involving upper-level management should be considered
more significant than those involving first-line supervisors.
Inattentiveness on the part of management should also be
considered, i.e., should management have been aware of the
violation?
e. What was the duration of the violation? If the condition existed
for an extended period, without discovery and correction, the risk
generally will be proportional to the duration of the violation and
the severity level of the violation should be increased.
f. Was DOE notified promptly and provided complete information
by the contractor when a violation was found? Delay in providing a
comprehensive report to DOE may indicate lack of contractor
initiative to improve safety at a facility. Furthermore, failure of a
contractor to report a violation to DOE in accordance established
reporting requirements may be considered a violation itself, in
addition to the violation that occurred.
g. Was the violation inadvertent or did it involve willfulness and, if
it did, to what extent? (See Section 1.4. for the definition of
willfulness and Section 5.5. for guidance regarding willful
violations.)
h. Was the violation related to a condition in a Compliance Order?
See 10 CFR 820.40 - 820.43. These violations may be more
significant because contractors have prior notice of the violation
and have not taken appropriate actions to correct it after having
been directed to do so by the Secretary.
Aggregation of Violations for Increased Severity Level:
A group of violations may be evaluated in the aggregate: (1) if they
have the same underlying cause or are attributable to management
deficiencies, or (2) they contributed to the same underlying effect,
and (3) the resulting severity level is a I, II or III.
Any circumstance involving numerous violations should be
considered for aggregation at a Severity Level II or III and when
appropriate, Severity Level I. However, both the number and nature
of the violations should be considered. Numerous violations that
are related, for example, those involving training, procedures, safety
evaluations, or management controls should be considered for
aggregation. A group of noncompliances can also be aggregated and
designated a violation at the appropriate severity level; if the facts
and circumstances merit such an action.
(Aggregation of violations to a higher severity level should not be
confused with the use of multiple examples in Notices of Violation
or the use of the multiple-occurrences in determining a severity
level.)
Repetitive Violations
Repetitive violations are of concern because DOE expects a
contractor's corrective actions to be effective in eliminating the
source of the problem causing the violation. DOE expects
contractors to learn from their past failures and not depend on
DOE's assessment programs to identify and correct violations of
nuclear safety requirements. Therefore, special attention is
appropriate for repetitive violations and escalated action should be
considered. At the same time, it is recognized that there are many
different circumstances that need to be considered. The following
general guidance is provided. It should be noted that for purposes
of this Handbook, the term "repetitive" violations is interchangeable
with the term "similar" violations.
a. A "similar" or "repetitive" violation is defined as a violation that
reasonably could have been prevented by a contractor's corrective
action for a previous noncompliance condition or violation of
nuclear safety requirements.
b. Previous noncompliance reports, enforcement actions,
assessment reports, or "open items" listings from assessment
reports, etc., should be used, as appropriate, to evaluate the
contractor's prior enforcement history, including noncompliance
items, to identify repetitive violations.
3.5.3. Incorporation of Related Violations
During the course of the development of an enforcement action,
additional information may be developed by DOE or the contractor
involving other violations of DOE nuclear safety requirements
related to the action being considered for enforcement.
These related violations are to be incorporated, if practical, into the
pending enforcement action. The purpose of incorporating these
violations into the pending action is to focus the contractor's
attention on the problem area, ensure that all relevant violations are
considered whenever the enforcement action is being evaluated, and
ensure that the safety significance of the violations is evaluated
appropriately.
The related violations may be identified at any stage of the
enforcement process. If new evidence is identified after the
enforcement action has been transmitted to the contractor, the
additional related findings are to be brought to the attention of the
contractor through a supplemental preliminary notice of violation.
If inclusion in the current enforcement action is deemed to be
practical and appropriate, the additional violation, the background
or reference material, and any clarifying information should be
forwarded to the contractor. If not considered feasible to be
included in the current enforcement action, the Director,
Enforcement and Investigation Staff, may initiate a separate
enforcement action, making appropriate reference to the current
one.
3.5.4. Investigation Preliminary Recommendations on Enforcement
Action
Based on the information obtained in the investigation, the
consideration of other factors affecting safety significance, and any
particular history of performance by the contractor, the
investigation needs to draw conclusions and put forth a
recommendation on enforcement action. This should include a
recommendation on severity level and consideration of monetary
civil penalty and mitigation factors, as appropriate.
Chapter 4 provides guidance on the determination of severity level
and corresponding civil penalty and adjustments. Preliminary
recommendations should be based on this guidance, and
subsequently adjusted if further information becomes available in
the enforcement process.
3.5.5. Enforcement Actions by other Agencies
DOE contractors may be subject to enforcement action by other
federal agencies (such as NRC, DOT, DOL-OSHA, or EPA), state,
or local government agencies. Sometimes, the violation of a DOE
nuclear safety rule may also constitute a violation of another
federal, state or local requirement. DOE may consider these other
actions in formulating its own enforcement action to assure that the
overall remedy is appropriate for the infraction, except if restricted
from doing so by legal restraints or agreements between DOE and
other agencies.
3.6. Informal Enforcement Conferences
Informal enforcement conferences may be called at any time at the
discretion of the Director, Enforcement and Investigation Staff, or
requested by the contractor. The primary purpose of an informal
enforcement conference is to discuss the preliminary conclusions of
an investigation, inquiry, inspection, or other documented sources
of information which provide a basis for concluding that a violation
of DOE nuclear safety requirements may have occurred. The initial
enforcement conference should take place prior to issuance of a
PNOV. The conference will include discussion of the safety
significance and cause(s) of the violation, any mitigating or
aggravating circumstances along with any other relevant
information. As appropriate, more than one enforcement conference
can be scheduled.
3.6.1. Enforcement Actions that Generally Will Require
Enforcement Conferences
An enforcement conference will normally be held in each of the
following cases:
a. Those involving potential Civil Penalty actions at any severity
level.
b. Selected Severity Level III violations which, if repeated, could
lead to an enforcement action at a high severity level.
c. Significant numbers of recurring noncompliances.
d. Similar Severity Level III violations for which a civil penalty may
be considered.
In addition, the Director, Enforcement and Investigation Staff, may
require a conference in any circumstance in which it is appropriate
for the clarification of matters in controversy and/or may lead to an
improvement in nuclear safety for workers and the public. A
contractor may request a conference at any time if none has been
set by the Director and such requests should be liberally granted.
3.6.2. Scheduling and Notification of Enforcement Conferences
In general, if an initial enforcement conference is planned, it should
be held before the PNOV is issued, usually within four weeks after
completion of the Enforcement and Investigation Staff investigation
that supports the basis for the proposed enforcement action. The
contractor should normally be informed of the staff's intent to
conduct an enforcement conference at least two weeks in advance
of the scheduled conference.
Refer to Section 5.2. for special procedures for cases that have been
referred to DOJ because these cases require coordination with DOJ
and approval of the Director, Enforcement and Investigation Staff,
prior to scheduling an enforcement conference.
If immediate enforcement action is necessary, the action may be
taken before an enforcement conference (See Section 3.5.).
Subsequent to taking immediate enforcement action, an
enforcement conference may be held.
An enforcement conference should normally be held at DOE-HQ
unless documentation is so voluminous that it is appropriate for
such a conference to be held on the site of the documentation. In
situations where numerous personnel may need to be consulted
during a course of a conference, consideration should be given to
scheduling the conference either at the DOE Operations Office or
the site. In general, such conferences should be informal without a
formal transcript of the proceedings.
3.6.3. Attendance at Enforcement Conferences
a. DOE Personnel
1.The Assistant Secretary, EH-1, may attend all conferences at his
or her discretion.
2.Designated Enforcement and Investigation Staff shall attend all
enforcement conferences in person. The Director, Enforcement and
Investigation Staff, will normally chair the enforcement conference
or designate a staff individual to chair the conference.
3.The Cognizant Secretarial Officer (CSO) or other DOE Field
Management representatives should attend enforcement
conferences to provide input regarding the safety significance of the
violation, root causes, special circumstances and
comprehensiveness of corrective action.
4.In order to promote fulfillment of its responsibilities under 10
CFR Part 820 Subpart D, representatives of the Office of General
Counsel may be invited by the Director, Enforcement and
Investigation Staff, to attend those conferences involving complex
or novel legal issues or those involving a complex or significant
investigation.
5.Investigatory organizations may be invited by the Director,
Enforcement and Investigation Staff, to attend those enforcement
conferences that involve a complex or significant investigation, or
those that could potentially result in referral for special
investigation.
6.Other EH personnel may attend the conference at the request and
under the direction of the Director, Enforcement and Investigation
Staff.
b. DOE Contractor Personnel
1.In order to assure a positive outcome from such activity the
Director, Enforcement and Investigation Staff, shall ensure that
contractor management participates in the enforcement conference
at the appropriate level. This may require participation by senior
management of the parent organization of the DOE contractor, if
determined to be appropriate by the Director.
2.The Director, Enforcement and Investigation Staff, should give
consideration to requiring attendance of the person(s) involved at
the enforcement conference. It may be beneficial for DOE
management to hear firsthand that individual's explanation for the
actions taken to understand more completely the circumstances of
the violation.
3.Contractors may invite their attorneys or consultants to attend
conferences. However, if classified information is disclosed or
discussed, appropriate clearances must be exhibited to DOE
personnel.
c. Media and Members of the Public
As stated in the Enforcement Policy, enforcement conferences are
predecisional actions and may involve classified information.
Therefore, they are normally closed meetings between DOE and the
contractor (including the parent organization's management). This
excludes the media and public from enforcement conferences,
although in some instances, a press conference may be held
afterwards or a press release issued if the Director, Enforcement
and Investigation Staff, or the Secretary believes it is appropriate.
3.6.4. Notification to Contractor of Informal Enforcement
Conference
DOE will generally prepare Notification of Scheduled Enforcement
Conference to inform the contractor and DOE personnel of the
plans and schedule for the Enforcement Conference. The
notification should describe the issues to be discussed to help
focus the conference on the issues and make it as meaningful as
possible. It is important to ensure that the contractor understands
what is expected of them at the conference. In general, telephone
discussions with the contractor may supplement the notification
letter to convey and/or clarify the issues to be discussed.
The notification should include the following:
(a) Schedule and location for the Enforcement Conference;
(b) DOE attendees planned for the conference, and personnel who
should attend from the contractor organization;
© Summary of DOE's conclusions and basis on the potential
violation based on information received to date;
(d) Any particular points or information the contractor should
address in the Enforcement Conference;
(e) If time prermits, the Notification should include an outlinre or
agenda of the specific issues to be discussed.
3.6.5. Conduct of Enforcement Conferences
a. Management Participation
Once a decision is made to hold an enforcement conference, the
Director, Enforcement and Investigation Staff, determines the level
of management representation required of the contractor, as well as
the level of DOE management participation in coorperation with
other DOE offices.
b. Conference Procedures
Enforcement conferences will be chaired by members of the
Enforcement and Investigation Staff. The Enforcement and
Investigation Staff shall be responsible for directing the
Enforcement Conference and as such, all positions on the proposed
enforcement action shall be presented by the DOE Chair or, at the
discretion of the Chair, by other appropriate DOE staff. This will
assure preparation of an appropriate agenda and assure that DOE
enforcement positions are not compromised.
c. Areas of Discussion
1. DOE's understanding of the facts and circumstances surrounding
the violation or problem should be discussed at the enforcement
conference. These discussions should include the safety
significance of the violation and the contractor's understanding of
the violation (i.e., whether or not the contractor agrees that the
violation occurred, and, if not, what additional facts it believes are
relevant). In addition, the contractor's explanation of the causes of
the violation, its views of its safety significance of the violation, the
corrective actions taken to correct the immediate problems and to
prevent future occurrences; and, if appropriate, any aggravating or
mitigating factors should be discussed. The contractor should
provide documented support of its positions if this information has
not been submitted earlier.
2. The primary purpose of the conference is to obtain information
relevant to the enforcement action and to have an open, frank
discussion of all elements of the violation. Its primary purpose is
not to negotiate sanctions. Although the contractor may provide
information that may be relevant to determining severity levels and
civil penalty amounts, in general the discussion will not focus on
issues such as specific severity levels, civil penalty amounts,
mitigation percentages, or the nature and content of any orders.
(See Section 3.14. for additional guidance concerning the release of
predecisional enforcement information to contractors.) If the
contractor offers its views on such issues, the Enforcement and
Investigation Staff will make clear that final DOE decisions on
such matters will be made subsequent to the conference and will be
provided to the contractor at a later date.
d. Depth of Detail
1.The following guidelines are appropriate to consider with respect
to the depth of detail and degree of debate permitted at enforcement
conferences.
2.The depth of detail of the discussion should be related to the
complexity and significance of the issues. Most of the detailed
information discussed should have been included in the
documented basis for the violation.
3.The information discussed should be sufficient to highlight the
alleged violation, any related violations, how the violation was
discovered, how DOE was notified of the violation, the cause of the
violation, and the corrective actions planned or taken including
whether or not those corrective actions, including the promptness
of such actions, are considered by DOE to be adequate.
4.An enforcement conference is not to be used as a forum for
protracted debate. Once the pertinent facts have been established,
the DOE Chair should recognize that a difference of opinion may
exist, and keep the enforcement conference moving forward.
5.If a contractor's stated position or the facts it presents are
different from those of DOE, this should be acknowledged to
preclude silence on the Enforcement and Investigation Staff's part
being misunderstood as a sign of agreement. This can be done in a
summary statement which recognizes the differences in position
between DOE and the contractor without prolonging debate of an
issue or point of fact.
3.6.6. Identification of Additional Violations
In the event additional facts are disclosed or developed at or after
the enforcement conference that could lead to the identification of
additional violations, special efforts should be taken to substantiate
these violations with probative evidence before they are included in
a proposed enforcement action. In addition, the contractor should
have an opportunity to discuss the apparent violation(s) in a
subsequent informal enforcement conference before it is formalized
and should provide any additional relevant information. Likewise,
the Director, Enforcement and Investigation Staff, may request a
follow-up enforcement conference. (See the guidance in Section
3.12. for the related issue of development of additional enforcement
actions.)
3.6.7. Enforcement Conference Summary Report
After the enforcement conference, a brief report is to be prepared
by the Enforcement and Investigation Staff to document the
conference discussions. It is not necessary to summarize all
discussion but all relevant discussion should be included. The
summary report should include the following information, as
applicable:
1.The date and place of the Enforcement Conference.
2.A list of the Enforcement Conference attendees from DOE and
the contractor.
3.A brief description of the contractor's position, i.e., if the
contractor agrees with the findings or if the contractor takes issue
with the potential violation(s).
4.A list of any doucments presented at the conference.
5.A summary of the factual information which provides the basis
for the violation.
6.A brief description of significant additions or corrections to the
factual information which is the basis for the violation.
7.A brief description of any significant additional information
which affects the management causes or safety significance of each
violation.
8.A description of any other points of significant disagreement.
9.A brief description of the contractor's short-term and long-term
corrective and remedial actions that it has implemented or has
committed to implement.
10.An analysis of all of the above information establishing DOE's
conclusion on the violation at that point in time.
The summary is especially important for those cases in which new
information is provided, errors are identified in the documented
basis for the violation, or significant clarifications of information
are provided. In some limited circumstances, it is possible that
providing a copy of documents produced at the conference may be
sufficient to summarize the enforcement conference discussions.
This summary report should be prepared so that it may be issued to
all DOE Enforcement Conference attendees no later than the date
the PNOV is issued, if the issuance of a PNOV is warranted by the
facts and circumstances. The report should be clearly marked as
"Predecisional Information, Not for Public Release." In the event it
is decided that a PNOV should not be issued, the summary report
should be provided to attendees within 21 days of the enforcement
conference.
Finally, enforcement conference summary reports should be
screened to make sure that classified information is not included. A
copy of the summary report should be provided to EH-1. A letter
should be sent to the contractor, including such information about
the enforcement conference as may be appropriate under the
circumstances of the matter in controversy.
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