[Federal Register Volume 74, Number 214 (Friday, November 6, 2009)]
[Notices]
[Pages 57525-57529]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-26816]
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NUCLEAR REGULATORY COMMISSION
[NRC-2009-0485]
Draft Safety Culture Policy Statement: Request for Public
Comments
AGENCY: Nuclear Regulatory Commission (NRC).
ACTION: Issuance of draft safety culture policy statement and notice of
opportunity for public comment.
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DATES: Comments are requested 90 days from the date of this Federal
Register Notice. Comments received after this date will be considered
if it is practical to do so, but the NRC is able to assure
consideration only for comments received on or before this date. Please
refer to the SUPPLEMENTARY INFORMATION section for additional
information including questions for which the NRC is requesting
comment.
ADDRESSES: You may submit comments by any one of the following methods.
Please include Docket ID NRC-2009-0485 in the subject line of your
comments. Comments submitted in writing or in electronic form will be
posted on the NRC Web site and on the Federal rulemaking website
Regulations.gov. Because your comments will not be edited to remove any
identifying or contact information, the NRC cautions you against
including any information in your submission that you do not want to be
publicly disclosed.
The NRC requests that any party soliciting or aggregating comments
received from other persons for submission to the NRC inform those
persons that the NRC will not edit their comments to remove any
identifying or contact information, and therefore, they should not
include any information in their comments that they do not want
publicly disclosed.
Federal Rulemaking Web site: Go to http://www.regulations.gov and
search for documents filed under Docket ID NRC-2009-0485. Address
questions about NRC dockets to Carol Gallagher 301-492-3668; e-mail
[email protected].
Mail comments to: Michael T. Lesar, Chief, Rulemaking and
Directives Branch (RDB), Division of Administrative Services, Office of
Administration, Mail Stop: TWB-05-B01M, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, or by fax to RDB at (301) 492-
3446.
FOR FURTHER INFORMATION CONTACT: Alexander Sapountzis, Office of
Enforcement, Mail Stop O-4 A15A, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, or by e-mail to
[email protected].
SUMMARY: The NRC is issuing a draft policy statement that sets forth
the Commission's expectation that all licensees and certificate holders
\1\ establish and maintain a positive safety culture that protects
public health and safety and the common defense and security when
carrying out licensed activities. The Commission defines safety culture
as that assembly of characteristics, attitudes, and behaviors in
organizations and individuals which establishes that as an overriding
priority, nuclear safety and security issues \2\ receive the attention
warranted by their significance. The Commission also considers nuclear
safety and security issues to be equally important in a positive safety
culture. The importance of treating safety and security in an equal
manner within NRC's regulatory framework is clearly evident in our
mission and strategic goals. Experience has shown that certain
organizational characteristics and personnel attitudes and behaviors
are present in a positive safety culture. These include, but are not
limited to, individuals demonstrating ownership and personal
responsibility for maintaining safety and security in their day-to-day
work activities; the implementation of processes for planning and
controlling work activities such that safety and security are
maintained; a work environment in which personnel feel free to raise
safety and security concerns without fear of retaliation; prompt and
thorough identification, evaluation, and resolution of nuclear safety
and security issues commensurate with their significance; the
availability of the resources needed to ensure that safety and security
are maintained; decision-making processes that protect safety and
security; clearly defined roles and responsibilities for maintaining
safety and security; and the seeking out and implementation of
opportunities to improve safety and security. The NRC expects its
licensees and certificate holders to foster these characteristics,
attitudes, and behaviors in their organizations and among individuals
who are overseeing or performing regulated activities commensurate with
the safety and security significance of their activities and the nature
and complexity of their organization and functions.
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\1\ Throughout this document, the phrase ``licensee and
certificate holders'' includes licensees, certificate holders,
permit holders, authorization holders, holders of quality assurance
program approvals and applicants for a license, certificate, permit,
authorization, or quality assurance program approval.
\2\ Throughout this document, the terms ``safety'' or ``nuclear
safety,'' ``security'' or ``nuclear security,'' and ``safety
culture'' are used. These terms refer to matters that are related to
NRC-regulated activities, including radiation protection,
safeguards, material control and accounting, physical protection,
and emergency preparedness.
.
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The NRC is requesting comments on the draft safety culture policy
statement and associated questions.
SUPPLEMENTARY INFORMATION:
(1) Background
The Commission has long expressed its expectations for safety
culture in previous policy statements. In 1989, the Commission
published its ``Policy Statement on the Conduct of Nuclear Power Plant
Operations'' (54 FR 3424; January 24, 1989) to make clear the
Commission's expectations of utility management and licensed operators
with respect to the conduct of operations. The policy statement stated,
``the phrase safety culture refers to a very general matter, the
personal dedication and accountability of all individuals engaged in
any activity which has a bearing on the safety of nuclear power
plants.'' The policy statement further stated that the Commission
issued the policy statement to help foster the development and
maintenance of a safety culture at every facility licensed by the NRC.
[[Page 57526]]
In 1996, the Commission published a policy statement, ``Freedom of
Employees in the Nuclear Industry to Raise Safety Concerns Without Fear
of Retaliation'' (61 FR 24336; May 14, 1996), to set forth its
expectations that licensees and other employers subject to NRC
authority will establish and maintain safety-conscious environments in
which employees feel free to raise safety concerns, both to their
management and to the NRC, without fear of retaliation. This policy
statement applied to NRC-regulated activities of all licensees and
their contractors and subcontractors. A safety conscious work
environment is an important attribute of safety culture and is one of
the safety culture characteristics in the draft safety culture policy
statement.
The importance of a positive safety culture for activities
involving civilian uses of radioactive materials and other potential
hazards has been demonstrated by a number of significant, high-
visibility events world-wide that have occurred in the 20-year period
since the Commission published its 1989 policy statement addressing
safety culture in nuclear power plants. The events occurred across
multiple industries including at nuclear power plants, fuel cycle
facilities, and in other industries such as chemical processing plants
and aerospace. Examples of nuclear industry events include those that
occurred at the Davis-Besse Nuclear Power Station and the Peach Bottom
Atomic Power Station. Workers at the Davis-Besse Nuclear Power Station
discovered a cavity in the reactor pressure vessel head caused by boric
acid corrosion. The corrosion developed over a period of several years
but was not discovered before the cavity developed. The licensee's
analysis of the event identified weaknesses in the station's safety
culture as the root cause of the event. It particularly noted that
management prioritized ``production over safety.'' At the Peach Bottom
Atomic Power Station, personnel behaviors adverse to the security of
the plant were identified, specifically, inattentiveness by security
officers.
Other licensees have had recurring problems resulting in violations
of NRC regulations. Through a Commission confirmatory order, a fuel
cycle facility licensee committed to having a third-party assessment of
its safety culture to determine the causes of its continuing problems
in order to establish appropriate corrective actions. The third-party
assessment identified weaknesses in areas important to safety culture.
In addition, weaknesses in the safety culture of licensees and
certificate holders have contributed to unscheduled events or incidents
that the Commission has determined to be significant from the
standpoint of public health and safety. Examples linked to
characteristics and attitudes in organizations and individuals
associated with weak safety cultures include inadequate procedures;
procedures not being followed; inadequate supervision; decision-making
that does not ensure that safety and security are maintained; and
ineffective problem identification, evaluation, and resolution. They
have included medical misadministrations (such as giving iodine-131 to
lactating females that resulted in the uptake by their infants and
multiple events associated with prostate brachytherapy treatment) and
overexposures arising from the loss of control of radiography or well
logging sources.
(2) Statement of Policy
It is the Commission's policy that a strong safety culture is an
essential element for individuals, both internal to the NRC and
external, performing or overseeing regulated activities. As such, the
NRC will include appropriate means to monitor safety culture in its
oversight programs and internal management processes. The NRC defines
safety culture as that assembly of characteristics, attitudes, and
behaviors in organizations and individuals, which establishes that as
an overriding priority, nuclear safety and security issues receive the
attention warranted by their significance. Further, it is important for
all organizations to provide personnel in the safety and security
sectors with an appreciation for the importance of each, emphasizing
the need for integration and balance to achieve optimized protection.
Safety and security activities are closely intertwined, and it is
critical that consideration of these activities be integrated so as not
to diminish or adversely affect either safety or security. A safety
culture that accomplishes this would include all nuclear safety and
security issues associated with NRC-regulated activities including
radiation protection, safeguards, material control and accounting,
physical protection, and emergency preparedness issues among the issues
that receive attention as a matter of priority.
The Commission's regulations are designed to protect both the
public and workers against radiation hazards from the use of
radioactive materials. The Commission's scope of responsibility
includes regulation of commercial nuclear power plants; research, test,
and training reactors; nuclear fuel cycle facilities; medical,
academic, and industrial uses of radioactive materials; and the
transport, storage, and disposal of radioactive materials and wastes.
The Commission carries out these responsibilities in numerous ways
including through such regulatory activities as inspecting licensed and
certified facilities and activities; collecting, analyzing, and
disseminating information about operational safety and security;
investigating nuclear incidents; and developing policy and providing
direction on safety and security issues.
The Commission believes that, because licensees and certificate
holders use or provide services related to the use of radioactive
material, they bear the primary responsibility for safely handling and
securing these materials. It is, therefore, each licensee's and
certificate holder's responsibility to develop and maintain a positive
safety culture which establishes that nuclear safety issues and nuclear
security issues, as an overriding priority, receive the attention
warranted by their significance. Therefore, licensees and certificate
holders should foster a positive safety culture in their organizations
and among individuals who are overseeing or performing regulated
activities. However, as the regulatory agency, the Commission has an
independent oversight role (through inspection and assessment
processes) including addressing licensees' and certificate holders'
performance related to areas important to safety culture.
(3) Safety Culture Concept
In 1991, as a result of the 1986 Chernobyl accident, the
International Nuclear Safety Group (INSAG) emphasized the concept of
safety culture for the nuclear industry in its report, INSAG-4,
``Safety Culture.'' INSAG is an advisory group to the International
Atomic Energy Agency (IAEA). The INSAG-4 definition of safety culture
is, ``that assembly of characteristics and attitudes in organizations
and individuals which establishes that, as an overriding priority,
nuclear plant safety issues receive the attention warranted by their
significance.''
Implied in the INSAG definition of safety culture is the
recognition that every organization is continually faced with resolving
conflicts among its goals for cost, schedule, and quality (or safety).
The organization's members (groups and individuals) also face conflicts
among different goals in performing their jobs. Management establishes
the framework (management systems, programs, processes) and
communicates its priorities for resolving
[[Page 57527]]
conflicts among different goals. Members of the organization work
within that framework and are influenced by management's priorities,
but they have their own beliefs and attitudes about what is important
and make individual choices on how to proceed when faced with multiple
competing goals. The INSAG definition emphasizes that in a positive
safety culture, the goal of maintaining nuclear safety receives the
highest priority in the organization's and individuals' decision-making
and actions when faced with a conflict with other organizational or
individual goals.
The Commission modified the INSAG definition of safety culture
which refers to ``nuclear plant safety.'' The Commission is strongly
committed to promoting positive safety cultures among its nuclear
reactor licensees; however, the Commission regulates many other
organizations and processes involving civilian uses of radioactive
materials. These regulated activities include industrial radiography
services; hospitals, clinics and individual practitioners involved in
medical uses of radioactive materials; research and test reactors;
large-scale fuel fabrication facilities; as well as nuclear power
plants. The Commission also regulates the construction of new
facilities where operations will involve radioactive materials with the
potential to affect public health and safety and the common defense and
security. Therefore, by revising the INSAG definition of safety culture
to replace ``nuclear plant safety'' with ``nuclear safety,'' the
Commission is emphasizing that it expects all of its licensees and
certificate holders to place the highest priority on nuclear safety
commensurate with the risks inherent in the regulated activities.
The Commission also modified the INSAG definition to adequately
capture or communicate the equal importance of nuclear security and
nuclear safety in a positive safety culture. Following the terrorist
attacks of September 11, 2001, the Commission increased its attention
to the important role of security in regulated facilities whose
operations can have an impact on public health and safety. The
Commission issued orders enhancing security at its NRC-regulated
facilities to further ensure public health and safety and the common
defense and security. One of the insights gained from the greater
emphasis on security is the importance of incorporating security
considerations into a safety culture and effectively managing the
safety and security interface. In general, the safety and security
interface refers to the organizational and individual awareness that
the functions and goals of safety and security must be considered
together so that actions to achieve either set of functions and goals
do not inadvertently compromise the other. Therefore, to emphasize the
equal importance of nuclear security and nuclear safety in a positive
safety culture, the Commission has added ``nuclear security'' to the
safety culture definition. The NRC's modified INSAG definition is
provided in the Statement of Policy section above.
(4) Stakeholder Outreach
The Commission's February 28, 2009, Staff Requirements Memorandum
(SRM)-COMGBJ-08-0001, ``A Commission Policy Statement on Safety
Culture,'' (ML080560476) stated in part that the staff should, as part
of its public stakeholder outreach, reach out to all types of licensees
and certificate holders. In the development of the draft policy
statement, the NRC staff sought insights and feedback from
stakeholders. This was accomplished by providing information in a
variety of forums such as stakeholder organization meetings,
newsletters, and teleconferences and by publishing questions in Federal
Register Notices entitled ``Safety Culture Policy Statement: Public
Meeting and Request for Public Comments'' (ML090260709) that were
related to the Commission's SRM. In addition, a significant stakeholder
outreach activity was accomplished by a public workshop held on
February 3, 2009, at NRC Headquarters in Rockville, Maryland. The staff
reviewed and considered the stakeholder feedback derived from these
different forums and incorporated it into the development of the draft
policy statement and recommendations.
(5) Safety and Security Culture
In SRM-COMGJB-08-0001, the Commission also considered whether
publishing the NRC's expectations for safety and security culture is
best accomplished in one safety/security culture statement or in two
separate statements, one each for safety and security, while still
considering the safety and security interface.
Based on a variety of sources including document reviews and
stakeholder feedback, the Commission concluded there is no one
definitive view of this issue, but the results weighed heavily toward a
single policy statement to be titled a ``Safety Culture Policy
Statement.'' Document reviews and stakeholder feedback suggested that a
single policy statement (1) builds on the fact that safety and security
have the same ultimate purpose of protecting people and the environment
from unintended radiation exposure and (2) encourages attention to the
ways safety and security interface. For these reasons, the Commission
determined that the term ``safety culture'' should include both safety
and security.
Safety and security have been the primary pillars of NRC's
regulatory programs. However, in the current heightened threat
environment, there has been a renewed focus on security, and the staff
has implemented a number of efforts to enhance security and strengthen
the safety and security interface. It is important to understand that
both safety and security share a common purpose of protecting public
health and safety. In today's environment, safety and security
activities are closely intertwined, and it is critical that
consideration of these activities be integrated so as to complement
each other and not diminish or adversely impact either safety or
security. Further, it is important for licensees and certificate
holders to provide personnel in the safety and security sectors with an
appreciation for the importance of each, emphasizing the need for
integration and balance to achieve optimized protection. The importance
of both safety and security in an equal and balanced manner within
NRC's regulatory framework is clearly evident in the Commission's
mission and strategic goals.
While many safety and security activities complement each other or
are synergistic, there remain areas where potential conflicts may
arise. It is then imperative that mechanisms be established to resolve
these potential conflicts to assure the adequate protection of public
health and safety and promote the common defense and security. Hence,
safety and security have implications for each other in connection with
all aspects of nuclear activities.
One potential challenge is the way in which individuals involved in
safety and security activities approach the goal of risk mitigation and
protection of public health and safety. The safety staff is typically
focused on preventing errors that would result in an inadvertent
accident while the security staff is focused on preventing deliberate
attacks or diversion of certain materials that could cause harm.
Another challenge is that the organization/facility must ensure that
the existence of motivated and capable persons with ill intent is
recognized and that the importance of nuclear security to prevent such
persons from unauthorized access is understood.
[[Page 57528]]
To manage these potential conflicts of challenges, the Agency has
recently issued regulations on the safety/security interface. An
overarching safety culture policy statement which encompasses security
supports and further enhances those regulations.
Based on the above considerations, the Commission concluded that a
single policy statement would accomplish its goal that, as an
overriding priority, safety issues and security issues receive the
attention warranted by their significance. Although, in some cases,
issues relating to security might be handled differently than issues
related to safety. A single policy statement recognizes there is one
overarching culture in an organization; however, safety and security
functions and goals must be treated equally within that overarching
safety culture.
(6) Characteristics of a Positive Safety Culture
Experience has shown that certain organizational attributes and
personnel attitudes and behaviors are present in a positive safety
culture. Therefore, in 2006, when the NRC implemented an enhanced
reactor oversight process (ROP) that more fully addressed safety
culture, it identified and incorporated safety culture components that
are overarching characteristics of a positive safety culture. The NRC
based its development of the safety culture components on a review of a
variety of sources of information including the Institute of Nuclear
Power Operations; the IAEA; the Nuclear Energy Agency; the regulatory
approaches of other domestic and international organizations; and the
organizational behavior, safety culture, and safety climate research
literature. The Commission presented drafts of the safety culture
components and aspects in frequent public meetings and modified them in
response to stakeholder feedback.
For the purpose of this policy statement, the NRC modified the ROP
safety culture components (termed ``safety culture characteristics'')
to explicitly address security in the safety culture characteristics
descriptions, create a more generic description for each safety culture
characteristic that would apply to the range of NRC licensees and
certificate holders, and maintain all the safety culture concepts in
the safety culture components. The staff presented the draft safety
culture characteristics for stakeholder comment in a February 3, 2009,
public workshop and on the NRC's public safety culture Web site (http://www.nrc.gov/about-nrc/regulatory/enforcement/safety-culture.html).
Although the safety culture characteristics themselves are
applicable to all licensees and certificate holders, there may be other
examples that more specifically address the unique characteristics of a
licensee's or certificate holder's environment (i.e., unique for
medical and industrial applications, operating reactors, research and
test reactors, fuel cycle facilities, and new reactor construction
environments). Hence, the Commission recognizes that these safety
culture characteristics are not all inclusive; other characteristics
and attitudes in organizations and individuals may be indicative of a
positive safety culture. However, the Commission expects its licensees
and certificate holders to consider the extent to which these
characteristics and attitudes are present in their organizations and
among individuals who are overseeing or performing regulated activities
and to take steps, if necessary, to foster a positive safety culture
commensurate with the safety and security significance of activities
and the nature and complexity of the licensee's or certificate holder's
organization and functions.
The following characteristics that are indicative of a positive
safety culture, are relevant across the broad range of activities
carried out by the nuclear industry, the Agreement States and the NRC,
and address the importance of nuclear safety and security:
Personnel demonstrate ownership for nuclear safety and
security in their day-to-day work activities by, for example, ensuring
that their day-to-day work activities and products meet professional
standards commensurate with the potential impacts of their work on
safety and security. They proceed with caution when making safety- or
security-related decisions and question their assumptions, especially
when faced with uncertain or unexpected conditions, to ensure that
safety and security are maintained.
Processes for planning and controlling work ensure that
individual contributors, supervisors, and work groups communicate,
coordinate, and execute their work activities in a manner that supports
safety and security. For example, individuals and work groups
communicate and cooperate during work projects and activities to ensure
their actions do not interact with those of others to adversely affect
safety or security. In addition, managers and supervisors are
accessible to oversee work activities, including those of contractors
or vendors, and they challenge work activities and work products that
do not meet their standards.
The organization maintains a safety conscious work
environment in which personnel feel free to raise safety and security
concerns without fear of retaliation. For example, claims of
harassment, intimidation, retaliation, and discrimination are
investigated consistent with the regulations regarding employee
protection. If an instance of harassment, intimidation, retaliation, or
discrimination for raising a safety or security concern is identified,
corrective actions are taken in a timely manner.
The organization ensures that issues potentially impacting
safety or security are promptly identified, fully evaluated, and
promptly addressed and corrected, commensurate with their significance.
The organization ensures that the personnel, equipment,
tools, procedures, and other resources needed to assure safety and
security are available. For example, training is developed and
implemented or accessed to ensure personnel competence. Procedures,
work instructions, design documentation, drawings, databases, and other
job aids and reference materials are complete, accurate, and up-to-
date.
The organization's decisions ensure that safety and
security are maintained. For example, production, cost, and schedule
goals are developed, communicated, and implemented in a manner which
demonstrates that safety and security are overriding priorities.
Roles, responsibilities, and authorities for safety and
security are clearly defined and reinforced. For example, personnel
understand their roles and responsibilities in maintaining safety and
security. Programs, processes, procedures, and organizational
interfaces are clearly defined and implemented as designed. Leaders at
all levels of the organization consistently demonstrate that safety and
security are overriding priorities.
The organization maintains a continuous learning
environment in which opportunities to improve safety and security are
sought out and implemented. For example, individuals are encouraged to
develop and maintain current their professional and technical
knowledge, skills, and abilities and to remain knowledgeable of
industry standards and innovative practices. Personnel seek out and
implement opportunities to improve safety and security performance.
[[Page 57529]]
(7) Implementation of Policy
This policy statement describes areas important to safety culture,
but it does not address how the nuclear industry, the Agreement States,
and the NRC should establish and maintain a positive safety culture in
their organizations. The nuclear industry, the Agreement States, and
the NRC differ in their size and complexity, infrastructure, and
organizational frameworks. Therefore, a single approach for
establishing and maintaining a positive safety culture is not possible.
Nevertheless, the Commission expects that nuclear safety and security
issues receive the attention warranted by their significance, and all
organizations consider and foster the safety culture characteristics
(commensurate with the safety and security significance of activities
and the nature and complexity of their organization and functions) in
carrying out their day-to-day work activities and decisions.
Questions for Which NRC Is Seeking Input
(1) The draft policy statement provides a description of areas
important to safety culture, (i.e., safety culture characteristics).
Are there any characteristics relevant to a particular type of licensee
or certificate holder (if so, please specify which type) that do not
appear to be addressed?
(2) Are there safety culture characteristics as described in the
draft policy statement that you believe do not contribute to safety
culture and, therefore, should not be included?
(3) Regarding the understanding of what the Commission means by a
``positive safety culture,'' would it help to include the safety
culture characteristics in the Statement of Policy section in the
policy statement?
(4) The draft policy statement includes the following definition of
safety culture: ``Safety culture is that assembly of characteristics,
attitudes, and behaviors in organizations and individuals which
establishes that as an overriding priority, nuclear safety and security
issues receive the attention warranted by their significance.'' Does
this definition need further clarification to be useful?
(5) The draft policy statement states, ``All licensees and
certificate holders should consider and foster the safety culture
characteristics (commensurate with the safety and security significance
of activities and the nature and complexity of their organization and
functions) in carrying out their day-to-day work activities and
decisions.'' Given the diversity among the licensees and certificate
holders regulated by the NRC and the Agreement States, does this
statement need further clarification?
(6) How well does the draft safety culture policy statement enhance
licensees' and certificate holders' understanding of the NRC's
expectations that they maintain a safety culture that includes issues
related to security?
(7) In addition to issuing a safety culture policy statement, what
might the NRC consider doing, or doing differently, to increase
licensees' and certificate holders' attention to safety culture in the
materials area?
(8) How can the NRC better involve stakeholders to address safety
culture, including security, for all NRC and Agreement State licensees
and certificate holders?
To ensure efficient consideration of your comments, please identify
the specific question numbers with your comments when applicable. When
commenting, please exercise caution with regard to site-specific
security-related information. Comments will be made available to the
public in their entirety. Personal information such as your name,
address, telephone number, and e-mail address will not be removed from
your submission.
Dated at Rockville, Maryland, this 30th day of October 2009.
For the Nuclear Regulatory Commission.
Cynthia A. Carpenter,
Director, Office of Enforcement.
[FR Doc. E9-26816 Filed 11-5-09; 8:45 am]
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