[Federal Register Volume 62, Number 29 (Wednesday, February 12, 1997)]
[Notices]
[Pages 6677-6680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-3465]
Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 /
Notices
[[Page 6677]]
NUCLEAR REGULATORY COMMISSION
[NUREG-1600]
Policy and Procedure for Enforcement Actions; Policy Statement
AGENCY: Nuclear Regulatory Commission.
ACTION: Policy Statement; amendment.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its
General Statement of Policy and Procedure for Enforcement Actions
(Enforcement Policy) to modify Supplement VI, ``Fuel Cycle and
Materials Operations,'' as well as to reflect recent NRC organizational
changes. The Supplement VI amendment is warranted to reflect experience
gained through fuel cycle enforcement actions and as a result of the
Commission's recently designated responsibility for jurisdiction over
the Gaseous Diffusion Plants (GDPs). The Enforcement Policy is also
being amended to establish base civil penalties for GDPs. By a separate
action published in this issue in the Federal Register, the Commission
has issued a final rule amending the current regulations that govern
GDPs. The revision to the Enforcement Policy reflects those amendments.
In addition, the Enforcement Policy is being amended to reflect
recent NRC organizational changes. These changes redesignate which NRC
officials are delegated the responsibility for performing certain
enforcement functions. A clarification is also being made to remove
ambiguity as to when the Commission is to be consulted prior to
issuance of certain actions proposing civil penalties.
DATES: This amendment is effective on February 12, 1997. Comments are
due on or before March 14, 1997.
ADDRESSES: Send written comments to: The Secretary of the Commission,
U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. ATTN:
Docketing and Service Branch. Hand deliver comments to: 11555 Rockville
Pike, Rockville, Maryland, between 7:45 am and 4:15 pm, Federal
workdays. Copies of comments received may be examined at the NRC Public
Document Room, 2120 L Street, NW (Lower Level), Washington, DC.
FOR FURTHER INFORMATION CONTACT: James Lieberman, Director, Office of
Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001, (301) 415-2741.
SUPPLEMENTARY INFORMATION:
The Commission's Enforcement Policy was first issued on September
4, 1980. The Enforcement Policy is published as NUREG-1600, ``General
Statement of Policy and Procedure for NRC Enforcement Actions (60 FR
34381; June 30, 1995).'' The Enforcement Policy has been amended on a
number of occasions, most recently on October 18, 1996 (61 FR 54461).
As a result of experience gained through fuel cycle enforcement actions
and amendments to 10 CFR part 76 being published today as a final
regulation, an amendment to the Enforcement Policy is warranted to
provide guidance on categorizing potential violations of 10 CFR part 76
and establish base civil penalties for violation of part 76. This
amendment to the Enforcement Policy is being issued concurrently with
the new rule.
Base Civil Penalties
Table 1A of the policy, which establishes base civil penalties for
different types of licensees, is being modified to add GDPs to category
``a.'' The amended table will provide that the base civil penalty for a
Severity Level I violation of the Commission's requirements by a GDP
will be at the statutory limit of $110,000. In accordance with Table
1B, base civil penalties for Severity Level II and III violations are
lesser amounts. In determining the proper civil penalty amount, the
Commission considered the structures of these tables, which generally
take 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 to
workers receive higher civil penalties. In the case of GDPs, there are
large numbers of workers at the sites, significant source term present
(i.e., inventory of licensed material), and various chemical and toxic
substances used as part of the GDPs operations. Therefore, in the event
of an accident, there is the potential for significant radiological and
non-radiological hazards to members of the public, including workers,
and the environment.
With regard to the secondary factor of ability to pay, it is not
the NRC's intention that the economic impact of a civil penalty be so
severe that it puts the licensee or certificate holder out of business
1 or adversely affects a licensee's or certificate holder's
ability to safely conduct licensed activities. The deterrent effect of
civil penalties is best served when the amount of penalties take into
account a licensee's or certificate holder's ability to pay. In this
case, issuing a civil penalty of less than $110,000 to the Corporation
for a significant violation would be disproportionate to the
Corporation's significant revenues. In other words, a civil penalty of
$110,000 for a Severity Level I violation would be financially
appropriate, but not financially crippling. In addition, a penalty
based on this amount should get more attention from the Corporation and
should have a greater deterrent effect.
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\1\ Orders, rather than civil penalties, are used when the
intent is to suspend or terminate licensed activities.
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Given the financial resources of GDPs, it is appropriate to utilize
significant civil penalties to provide an effective deterrence from
violating the Commission's requirements such that the likelihood of
performance necessitating a shutdown order would be minimal.
Accordingly, a base civil penalty of $110,000 is appropriate in view of
the potential consequences during an accident and the ability to pay.
In addition, establishing the base civil penalty at the statutory limit
would provide, at the outset, a clear message concerning the cost of
noncompliance and additional motivation to maintain safety and
compliance.
Severity Levels
The policy recognizes that regulatory requirements have varying
degrees of safety, safeguards, or environmental significance.
Therefore, the relative importance of each violation, including both
the technical significance and the regulatory significance, is
evaluated as the first step in the enforcement process. In considering
the significance of a violation, the staff considers the technical
significance (i.e., actual and potential consequences) and regulatory
significance. Supplement VI, ``Fuel Cycle and Materials Operations,''
is being amended to provide additional examples for categorizing the
severity levels of violations.
The changes are:
Severity Level I
1. Example A.5, which is being added to Supplement VI, is
consistent with Supplement I guidance. This example is applicable for
the Gaseous Diffusion Plants (GDPs) because other fuel facilities do
not have Technical Safety Requirements (TSRs). Safety limits are those
bounds within which the process variables must be maintained for
adequate control of the operation and that must not be exceeded in
order to protect the integrity of the physical
[[Page 6678]]
system that is designed to guard against the uncontrolled release of
radioactivity.
2. Example A.6 is being added to Supplement VI to emphasize that 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, is of very significant regulatory concern.
This concern exists because an actual impact to the health and safety
of the public or workers has occurred from activities related to the
processing of radioactive material.
Severity Level II
1. Example B.4 is being added to Supplement VI to emphasize that,
although less significant than Example A.3 in Supplement VI, the
absence of all the criticality safety controls for a single anticipated
or unanticipated nuclear criticality scenario is of very significant
regulatory concern when the availability of fissile material makes a
nuclear criticality accident possible.
2. Example B.5 is being added to Supplement VI to underscore that
events which do not involve actual significant injuries or loss of
life, but reasonably could have if circumstances had been different,
are considered of very significant regulatory concern.
Severity Level III
1. Example C.5 is being modified in Supplement VI so that it is
consistent with Supplement IV guidance. The NRC considers that a
substantial potential for exposures, radiation levels, contamination
levels, or releases (including releases of toxic material) caused by
the failure to comply with NRC regulations or with procedures
established to comply with license conditions to be a significant
regulatory concern because it could have serious consequences to the
public and licensee employees.
2. Example C.12 is being added to Supplement VI to emphasize that
the failure of a certified facility to comply with a limiting condition
for operation is considered a significant regulatory concern. This
example is similar to Supplement I guidance and has been selected for
the GDPs because other fuel cycle facilities do not have TSRs.
3. Example C.13 is being added to Supplement VI to emphasize that
the loss of defense-in-depth over licensed or certified activities is
considered a significant regulatory concern. This example is consistent
with Supplement I guidance and is applicable to both fuel cycle and
gaseous diffusion operations.
4. Example C.14, which is consistent with Supplement I guidance, is
being added to Supplement VI. This example is generally applicable to
the fuel cycle facilities.
5. Example C.15 is being added to Supplement VI. The failure to
meet the requirements of 10 CFR 76.68 is significant because of the
importance of certificate holders using the required process for
maintaining and operating the facilities in accordance with the design
and procedures described in their safety analysis report when there is
uncertainty as to whether an unreviewed safety question is present. An
after-the-fact evaluation that demonstrates that an unreviewed safety
question was not involved would, in general, not mitigate the
regulatory significance of failing to perform an appropriate evaluation
prior to implementation of the change.
6. Example C.16 is being added to Supplement VI to emphasize that
adequate control over vendors or contractors performing safety-related
work or providing safety-related services is a significant regulatory
concern. This example amplifies the NRC's concern that all safety-
related activities, whether performed by the certificate holder or by
one of its contractors, be conducted in accordance with the
requirements in the application, TSRs and certificates.
7. Example C.17, which is consistent with the Supplement I
guidance, is being added to Supplement VI. This example points out that
equipment failures caused by inadequate or improper maintenance that
substantially complicates recovery from a plant transient is a
significant regulatory concern.
8. Example C.18 is being added to Supplement IV. This example
indicates that the absence of all but one criticality safety control
for a single anticipated or unanticipated nuclear criticality scenario
is a significant regulatory concern when a critical mass of fissile
material was present or reasonably available, because a nuclear
criticality accident was possible.
Severity Level IV
1. Although less significant than the above examples, examples D.5
through D.8 are being added to Supplement VI to stress that such
failures are more than a minor concern because they could lead to a
more serious concern if left uncorrected.
Organizational Changes
In addition to the above changes, recent NRC organizational changes
have redistributed certain staff functions reporting to the Executive
Director for Operations. Under the previous organization, the Deputy
Executive Director for Nuclear Material Safety, Safeguards, and
Operations Support (DEDS) was delegated the authority to approve and/or
issue escalated enforcement actions associated with licensees of the
Office of Nuclear Material Safety and Safeguards (NMSS). Similarly, the
Deputy Executive Director for Nuclear Reactor Regulation, Regional
Operations, and Research (DEDR) was delegated the authority to approve
and/or issue escalated enforcement actions associated with licensees of
the Office of Nuclear Reactor Regulation (NRR). Based on this
distribution of functions, these two Deputy Executive Directors were
designated as the principal enforcement officers of the NRC.
The NRC organizational changes have replaced the previous two
Deputy Executive Director positions with three new Deputy Executive
Director positions. Under the new organizational arrangement, the NRC
Office of Enforcement (OE) reports to the Deputy Executive Director for
Regulatory Effectiveness, Program Oversight, Investigations, and
Enforcement (DEDO), and NMSS and NRR both report to the Deputy
Executive Director for Regulatory Programs (DEDR). This change in
reporting responsibilities consolidates the technical office oversight
under the new DEDR, and redesignates a single deputy, the DEDO, as the
NRC's principal enforcement officer.
Consistent with this change, the NRC Enforcement Policy is being
modified to replace all previous references to either Deputy Executive
Director with references to the DEDO. As such, the Enforcement Policy
will designate the DEDO as having the authority to approve and/or issue
escalated enforcement actions associated with either NRR or NMSS
licensees. These changes will be reflected in the amendment to NUREG-
1600.
Clarification
The Commission previously published (61 FR 65088, December 10,
1996) changes to the Enforcement Policy concerning consultation with
the Commission prior to issuance of enforcement actions that proposed a
civil penalty more than three times the Severity Level value shown in
Table 1A for a single violation. The Commission is re-publishing that
portion of the Policy (Section III.2) with slightly revised language to
remove ambiguity and make clear that the requirement applies to a
single violation or problem and not the total of multiple penalties
[[Page 6679]]
that may be proposed in one enforcement action. This is consistent with
the Commission's original understanding and intent.
Paperwork Reduction Act Statement
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 3150-0136. The
approved information collection requirements contained in this policy
statement appear in Section VII.C.
Public Protection Notification
The NRC may not conduct 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, the NRC has determined that this action is not a
``major rule'' and has verified this determination with the Office of
Information and Regulatory Affairs, Office of Management and Budget.
Accordingly, the NRC Enforcement Policy is amended by:
a. Changing the first paragraph under Section III,
``Responsibilities,'' by designating the principal enforcement officer
of the NRC as ``the Deputy Executive Director for Regulatory
Effectiveness, Program Oversight, Investigations, and Enforcement
(DEDO), hereafter referred to as the Deputy Executive Director,'' and
deleting the references to the former Deputy Executive Director for
Nuclear Material Safety, Safeguards, and Operations Support (DEDS) and
the former Deputy Executive Director for Nuclear Reactor Regulation,
Regional Operations, and Research (DEDR).
b. Revising all subsequent references to ``the appropriate Deputy
Executive Director'' to read ``the Deputy Executive Director.''
c. Revising Section III, ``Responsibilities,'' Section VI,
``Enforcement Actions,'' Subsection B., Table 1A, Category a., and
Supplement VI, ``Fuel Cycle and Materials Operations,'' as follows:
General Statement of Policy and Procedure for NRC Enforcement
Actions
* * * * *
III. Responsibilities
* * * * *
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. In addition, the Commission will be consulted prior to taking
action in the following situations (unless the urgency of the situation
dictates immediate action):
* * * * *
(2) Proposals to impose a civil penalty for a single violation or
problem that is greater than 3 times the Severity Level I value shown
in Table 1A for that class of licensee;
* * * * *
VI. Enforcement Actions
* * * * *
B. Civil Penalty
Table 1A--Base Civil Penalties
a. Power reactors and gaseous diffusion plants............. $110,000
b. Fuel fabricators, industrial processors, and independent
spent fuel and monitored retrievable storage installations 27,500
c. Test reactors, mills and uranium conversion facilities,
contractors, vendors, waste disposal licensees, and
industrial radiographers.................................. 11,000
d. Research reactors, academic, medical, or other material
licensee \1\.............................................. 5,500
\1\ This applies to nonprofit institutions not otherwise categorized in
this table, mobile nuclear services, nuclear pharmacies, and physician
offices.
* * * * *
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, gaseous diffusion
plants, and materials operations.
A. Severity Level I--Violations involving for example:
* * * * *
3. A nuclear criticality accident;
4. A failure to follow the procedures of the quality management
program, required by 10 CFR 35.32, that results in a death or serious
injury (e.g., substantial organ impairment) to a patient;
5. A safety limit, as defined in 10 CFR 76.4, the Technical Safety
Requirements, or the application being exceeded; or
6. Significant injury or loss of life due to a loss of control over
licensed or certified activities, including chemical processes that are
integral to the licensed or certified activity, whether radioactive
material is released or not.
B. Severity Level II--Violations involving for example:
* * * * *
2. A system designed to prevent or mitigate a serious safety event
being inoperable;
3. A substantial programmatic failure in the implementation of the
quality management program required by 10 CFR 35.32 that results in a
misadministration;
4. A failure to establish, implement, or maintain all criticality
controls (or control systems) for a single nuclear criticality scenario
when a critical mass of fissile material was present or reasonably
available, such that a nuclear criticality accident was possible; or
5. The potential for a significant injury or loss of life due to a
loss of control over licensed or certified activities, including
chemical processes that are integral to the licensed or certified
activity, whether radioactive material is released or not (e.g.,
movement of liquid UF6 cylinder by unapproved methods).
C. Severity Level III--Violations involving for example:
1. A failure to control access to licensed materials for radiation
protection purposes as specified by NRC requirements;
* * * * *
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;
* * * * *
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
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location where licensed activities are being conducted, or where
licensed material is being stored where the new facilities do not meet
safety guidelines; or a change in the quantity or type of radioactive
material being processed or used that has radiological significance;
11. A significant failure to meet decommissioning requirements
including a failure to notify the NRC as required by regulation or
license condition, substantial failure to meet decommissioning
standards, failure to conduct and/or complete decommissioning
activities in 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., 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;
15. A significant failure to meet the requirements of 10 CFR 76.68,
including a failure such that a required certificate amendment was not
sought;
16. A failure of the certificate holder to conduct adequate
oversight of vendors or contractors 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 substantially complicates recovery from a plant transient; or
18. A failure to establish, maintain, or implement all but one
criticality control (or control systems) for a single nuclear
criticality scenario when a critical mass of fissile material was
present or reasonably available, such that a nuclear criticality
accident was possible.
D. Severity Level IV--Violations involving for example:
* * * * *
2. Other violations that have more than minor safety or
environmental significance;
3. Failure to follow the quality management (QM) program, including
procedures, whether or not a misadministration occurs, provided the
failures are isolated, do not demonstrate a programmatic weakness in
the implementation of the QM program, and have limited consequences if
a misadministration is involved; failure to conduct the required
program review; or failure to take corrective actions as required by 10
CFR 35.32;
4. A failure to keep the records required by 10 CFR 35.32 or 35.33;
5. A less significant failure to comply with the Action Statement
for a Technical Safety Requirement Limiting Condition for Operation
when the appropriate action was not taken within the required time;
6. A failure to meet the requirements of 10 CFR 76.68 that does not
result in a Severity Level I, II, or III violation;
7. A failure to make a required written event report, as required
by 10 CFR 76.120(d)(2); or
8. A failure to establish, implement, or maintain a criticality
control (or control system) for a single nuclear criticality scenario
when the amount of fissile material available was not, but could have
been sufficient to result in a nuclear criticality.
* * * * *
Dated at Rockville, Maryland, this 6th day of February, 1997.
For the Nuclear Regulatory Commission.
John C. Hoyle,
Secretary of the Commission.
[FR Doc. 97-3465 Filed 2-11-97; 8:45 am]
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