[Federal Register Volume 75, Number 180 (Friday, September 17, 2010)]
[Notices]
[Pages 57081-57086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-23249]


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NUCLEAR REGULATORY COMMISSION

[NRC-2010-0282]


Revised Draft Safety Culture Policy Statement: Request for 
Comments

AGENCY: Nuclear Regulatory Commission (NRC).

ACTION: Issuance of revised Draft Safety Culture Policy Statement and 
notice of opportunity for public comment.

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DATES: Comments are requested 30 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 only able to assure 
consideration of comments received on or before this date. Please refer 
to the SUPPLEMENTARY INFORMATION section for additional information 
including specific 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-2010-0282 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 Web site 
www.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. Additionally, 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-2010-0282. Address 
questions about NRC dockets to Carol Gallagher 301-492-3668; e-mail 
<a href="/cdn-cgi/l/email-protection#89cae8fbe6e5a7cee8e5e5e8eee1ecfbc9e7fbeaa7eee6ff"><span class="__cf_email__" data-cfemail="97d4f6e5f8fbb9d0f6fbfbf6f0fff2e5d7f9e5f4b9f0f8e1">[email protected]</span></a>.
    Mail comments to: Cindy K. Blady, Chief, Rules, Announcements, and 
Directives Branch (RADB), 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 RADB at (301) 492-
3446.

FOR FURTHER INFORMATION CONTACT: Maria E. Schwartz or Catherine 
Thompson at the U.S. Nuclear Regulatory Commission, Office of 
Enforcement, Mail Stop O-4 A15A, Washington, DC 20555-0001 or by e-mail 
or telephone to <a href="/cdn-cgi/l/email-protection#1b567a69727a354878736c7a696f615b756978357c746d"><span class="__cf_email__" data-cfemail="2a674b58434b047949425d4b585e506a445849044d455c">[email protected]</span></a>, (301) 415-1888, or 
<a href="/cdn-cgi/l/email-protection#cc8fadb8a4a9bea5a2a9e298a4a3a1bcbfa3a28ca2beafe2aba3ba"><span class="__cf_email__" data-cfemail="337052475b56415a5d561d675b5c5e43405c5d735d41501d545c45">[email protected]</span></a>, (301) 415-3409.

SUMMARY: On November 6, 2009, the NRC published a draft policy 
statement,'' Safety Culture Policy Statement,'' in the Federal Register 
(FRN) (74 FR 57525; NRC ADAMS Accession Number ML093030375).\1\ The 
Statement of Policy (SOP) contained in the FRN focuses on the interface 
of nuclear safety and security in a positive safety culture, and 
highlights the Commission's expectation that all licensees and 
certificate holders \2\ 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 FRN requested 
that interested persons provide comments within 90 days of its 
publication. On January 12, 2010, the comment period was extended to 
March 1, 2010 (75 FR 1656; ML100050288). As part of its outreach 
activities, the NRC held a Safety Culture Workshop in February 2010 
that provided a venue for interested parties to provide comments on the 
draft safety culture policy statement. The additional goal of the 
workshop was for panelists representing a broad range of stakeholders 
to reach alignment on a common definition of safety culture and a high-
level set of traits that describe areas important to a positive safety 
culture. The workshop panelists, with the assistance of the other 
workshop participants, developed both. Following the February workshop, 
the staff evaluated the public comments that were submitted in response 
to the November 2009 FRN. Additionally, the staff participated on 
panels and made presentations at various industry forums in order to 
provide information to stakeholders about the development of the safety 
culture policy statement and/or to obtain additional input and to 
ascertain whether the draft definition and traits developed at the 
workshop accurately reflect a broad range of stakeholders' views.
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    \1\ The Commission may use a policy statement to address matters 
relating to areas that are within NRC jurisdiction and are of 
particular interest to the Commission in order to guide staff's 
activities and to express its expectations; however, policy 
statements, unlike regulations/rules are not binding upon, or 
enforceable against, NRC or Agreement State licensees and 
certificate holders.
    \2\ The reference in the November 2009 FRN to ``licensee and 
certificate holder'' included 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.
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    In its ongoing effort to continue this dialogue with stakeholders, 
the NRC is publishing this FRN containing the revised draft SOP for a 
30-day public comment period. The revised draft SOP, including the 
revised definition and traits, is based on careful consideration of the 
Commission guidance in the October 2009 Staff Requirements Memorandum 
(SRM) for SECY-09-0075 (ML092920099), the NRC staff's evaluation of the 
public comments received on the November 2009 FRN, the revised 
definition and traits developed at the February 2010 workshop, and the 
outreach efforts the NRC staff has engaged in since February 2010.
    The information contained in this FRN will be used to focus 
discussions at a public meeting the NRC is holding on September 28, 
2010, at its Las Vegas, Nevada, hearing facility. Both this FRN and the 
September meeting are intended to provide additional opportunities for 
stakeholders to provide comments on the revised draft SOP, including 
the revised draft definition and traits.

I. Background

Previous Policy Statements

    While the NRC has increased its attention on the importance of a 
positive safety culture, the agency has long recognized the importance 
of a work environment with a safety-first focus. In 1989, in response 
to an incident involving operators sleeping in the control room, the 
NRC issued a policy statement on the conduct of operations which 
describes the NRC's expectation that licensees place appropriate 
emphasis on safety in the operations of nuclear power plants. The 
``Policy Statement on the Conduct of Nuclear Power Plant Operations'' 
(54 FR 3424; January 24, 1989) states the Commission's expectations of 
utility management and licensed operators with respect to the conduct 
of operations, noting that it applies to all individuals engaged in any 
activity which has a bearing on the safety of nuclear power plants. The 
Commission issued the policy statement to help foster the development 
and maintenance of a positive safety culture at these facilities.

[[Page 57082]]

    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 establish and maintain safety-conscious work 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 applies to the regulated activities of all NRC licensees and 
their contractors and subcontractors. A safety conscious work 
environment is an important attribute of a positive safety culture and 
is one of the safety culture characteristics in the initial draft 
safety culture policy statement. It is also one of the revised traits 
captured by the February 2010 workshop participants as an ``Environment 
for Raising Concerns.''

Events Underscoring the Importance of a Positive Safety Culture

    The importance of a positive safety culture has been demonstrated 
by a number of significant, high-visibility events world-wide involving 
civilian uses of radioactive materials that have occurred in the 20-
year period since the Commission published its 1989 policy statement. 
These events are not confined to a particular type of licensee or 
certificate holder as they occurred at nuclear power plants and fuel 
cycle facilities and during medical and industrial activities involving 
regulated materials. Because of their significance to public health and 
safety, the Commission has required the regulated entity involved to 
determine the underlying root causes of the problem and, in some 
instances, to commit to having a third-party assessment of its safety 
culture in order to establish appropriate corrective actions. These 
assessments have revealed that weaknesses in the regulated entities' 
safety culture were an underlying root cause of the problem or 
increased the severity of the problem. These root causes included, for 
example, inadequate management oversight of process changes, perceived 
production pressures, lack of a questioning attitude, and poor 
communications.
    One such incident indicated the need for additional NRC efforts to 
evaluate whether it should increase its attention to reactor licensees' 
safety cultures. During a planned outage, a nuclear power plant 
licensee discovered a cavity caused by boric acid corrosion in the top 
of the reactor pressure vessel. In response to this serious 
deterioration, the NRC required the licensee to determine the 
underlying root causes of the problem. The licensee's evaluation 
identified that the root causes for the failure to take appropriate 
corrective actions included an inadequate safety culture and an 
emphasis on production over safety. NRC lessons learned from this 
incident indicated the need for additional NRC efforts to evaluate 
nuclear power plant licensees' safety cultures. In SRM-SECY-04-0111 
(ML042430661), dated August 30, 2004, the Commission approved the 
staff's plan to enhance the Reactor Oversight Process (ROP) treatment 
of cross-cutting issues to more fully address safety culture. As part 
of this effort, the staff made important changes to the ROP to address 
Commission direction, including: (1) Enhancements to problem 
identification and resolution initiatives; (2) inspector training on 
safety culture; (3) establishment of processes for revising the ROP 
while involving stakeholders; (4) evaluation of safety culture at 
plants in the Degraded Cornerstone Column of the ROP Action Matrix; and 
(5) the treatment of cross-cutting issues to more fully address safety 
culture. Commission paper SECY-06-0122, dated May 24, 2006, 
(ML061320282) describes the NRC's safety culture activities at that 
time and the outcomes of those activities. On July 31, 2006, the agency 
issued Regulatory Issue Summary 2006-13, ``Information on the Changes 
Made to the Reactor Oversight Process to More Fully Address Safety 
Culture,'' (ML061880341) to provide information to nuclear power 
reactor licensees on the revised ROP.

Increased Focus on Security Issues

    Following the terrorist attacks of September 11, 2001, the 
Commission increased its focus on the security of regulated facilities 
whose operations can have an impact on public health and safety. The 
Commission issued orders enhancing security at these facilities. During 
the early years of implementation of these security enhancements, 
several violations of the Commission's security requirements were 
identified, in which the licensee failed to cultivate an effective 
safety culture in its security program. The most visible of these 
involved a culture of complacency involving security officers sleeping 
while on shift at a nuclear power plant. Most of these violations 
involved inadequate management oversight of security, lack of a 
questioning attitude within the security organization, inability to 
raise concerns about security issues, and inadequacy of training for 
security personnel. These issues prompted the Commission in SECY-09-
0075 to direct the staff to evaluate ``[w]hether publishing NRC's 
expectations for safety culture and for 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 interfaces.'' Based on the staff's 
review and stakeholder feedback, the staff concluded that the 
Commission's expectations for safety culture should be published in one 
policy statement entitled, ``A Safety Culture Policy Statement,'' but 
should emphasize that safety and security be treated in a balanced, 
commensurate with the significance, manner, within the overarching 
safety culture. Thus, while the term ``security'' is not included in 
the revised draft definition of safety culture, as the preamble to the 
traits points out, the traits of an effective safety culture should be 
balanced commensurate with their significance in ensuring that the 
security program is effectively implemented.
    Additionally, one of the insights gained from the increased 
emphasis on security is the importance of incorporating security 
considerations into a safety culture and effectively managing the 
safety and security interface. An effective safety and security 
interface integrates safety and security activities so as not to 
diminish or adversely affect either. Capturing both safety and security 
activities under an overarching safety culture policy statement is 
important because, while many safety and security activities complement 
each other, there may be instances in which safety and security 
interests create competing goals. Mechanisms should be established to 
identify and resolve these differences.

II. Development of the Current Statement of Policy

Commission Direction

    In February 2008, the Commission issued SRM-COMGBJ-08-0001 
(ML080560476) directing the NRC staff to expand the Commission's policy 
on safety culture to address the unique aspects of security and to 
ensure the resulting policy is applicable to all licensees and 
certificate holders. The Commission posed several additional questions 
for the staff to answer including (1) whether safety culture as applied 
to reactors needs to be strengthened; (2) how to increase attention to 
safety culture in the materials area; (3) how stakeholder involvement 
can most effectively be used to address safety culture for all NRC and 
Agreement State licensees and

[[Page 57083]]

certificate holders, including any unique aspects of security; and (4) 
whether publishing NRC's expectations for safety culture and for 
security culture is best accomplished in one safety/security culture 
statement or in two separate statements while still considering the 
safety and security interfaces.
    To address the Commission's direction, NRC staff reviewed domestic 
and international safety culture related documents, considered NRC 
lessons learned, and obtained wide ranging stakeholder input on 
questions related to the issues in the SRM. In February 2009, the NRC 
held a public workshop on the ``Development of a Policy Statement(s) on 
Safety and Security Culture'' in which a broad range of stakeholders 
participated, including a representative from the Agreement States 
(Meeting Summary: ML090930572). The 2009 workshop developed a draft 
definition and characteristics \3\ of a positive safety culture. 
Additionally, mindful of the increased attention to the important role 
of security, the staff also sought input from the workshop participants 
on whether there should be a single safety culture policy statement or 
two policy statements addressing safety and security independently 
while considering the interface of both. The staff also sought input on 
the additional questions the Commission posed to the staff in SRM-
COMGBJ-08-0001.
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    \3\ At the February 2010 workshop, the panelists referred to the 
characteristics (NRC term) or principles (INPO term) as traits. The 
term ``traits'' is used in the revised draft SOP and throughout this 
FRN and describes areas important to a positive safety culture.
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    The staff provided its recommendations to the Commission in May 
2009 in Commission paper SECY-09-0075, ``Safety Culture Policy 
Statement'' (ML091130068). Based on its review and stakeholder 
feedback, the staff (1) concluded that the NRC's oversight of safety 
culture as applied to reactors has been strengthened, is effective, and 
continues to be refined in accordance with the existing reactor 
oversight process (ROP) self-assessment process; (2) described actions 
taken and planned for increasing attention to safety culture in the 
materials area; (3) described actions taken and planned for most 
effectively utilizing stakeholder involvement to address safety 
culture, including any unique aspects of security, for all NRC and 
Agreement State licensees and certificate holders; and (4) developed 
one draft safety culture policy statement that acknowledges the equal 
importance of safety and security within the overarching safety 
culture.
    In SRM-SECY-09-0075 (ML092920099), the Commission directed the 
staff to: (1) Continue to engage a broad range of stakeholders, 
including the Agreement States and other organizations with an interest 
in nuclear safety, to ensure the final policy statement presented to 
the Commission considers a broad spectrum of views and provides the 
necessary foundation for safety culture applicable to the entire 
nuclear industry; (2) make the necessary adjustments to encompass 
security within the statement; (3) seek opportunities to comport NRC 
terminology, where possible, with that of existing standards and 
references maintained by those that the NRC regulates; and (4) consider 
incorporating suppliers and vendors of safety related components in the 
safety culture policy statement.

February 2010 Workshop

    The February 2010 workshop was part of the staff's efforts to 
further engage all NRC-regulated entities as well as the Agreement 
States, the Indian Tribes, and organizations and individuals interested 
in nuclear safety. The goals of the February workshop were to (1) 
provide an additional opportunity for comments on the November 2009 FRN 
and (2) develop a common definition of safety culture and a high-level 
set of traits describing areas important to a positive safety culture. 
The workshop participants represented a wide range of stakeholders 
regulated by the NRC and/or the Agreement states including medical, 
industrial, and fuel cycle materials users, and nuclear power reactor 
licensees, as well as the Nuclear Energy Institute (NEI), the Institute 
of Nuclear Power Operations (INPO), and members of the public. The 
workshop panelists reached alignment with input from the other meeting 
attendees on a common definition of safety culture and a high-level set 
of traits describing areas important to a positive safety culture.

Additional Outreach Activities

    Following the February workshop, the staff evaluated the public 
comments that were submitted in response to the initial draft SOP. 
Additionally, the staff participated on panels and made presentations 
at various industry forums in order to provide information to 
stakeholders about the development of the safety culture policy 
statement and/or to obtain additional input and to ascertain whether 
the draft definition and traits developed at the workshop accurately 
reflect a broad range of stakeholders' views. These outreach activities 
included, for example, participation in a Special Joint Session on 
Safety Culture at the Health Physics Society Annual Meeting, and 
presentations on the development of the Safety Culture Policy Statement 
at the Annual Fuel Cycle Information Exchange, the Conference of 
Radiation Control Program Directors' Annual National Conference on 
Radiation Control, the Institute of Nuclear Materials Management's 
Annual Meeting, the 2nd NRC Workshop on Vendor Oversight for New 
Reactors, and the Organization of Agreement States Annual Meeting.

III. Statement of Policy

    The purpose of this Statement of Policy is to set forth the Nuclear 
Regulatory Commission's expectation that individuals and organizations, 
performing or overseeing regulated activities involving nuclear 
materials, establish and maintain a positive safety culture 
commensurate with the safety and security significance of their 
activities and the nature and complexity of their organizations and 
functions. This applies to all licensees, certificate holders, permit 
holders, authorization holders, holders of quality assurance program 
approvals, vendors, suppliers of safety related components, and 
applicants for a license, certificate, permit, authorization, or 
quality assurance program approval, subject to NRC authority. 
Additionally, it is the Commission's expectation that the Agreement 
States and other organizations interested in nuclear safety will 
support the development and maintenance of a positive safety culture, 
as articulated in this Statement of Policy, within their regulated 
communities.
    The Commission defines Nuclear Safety Culture as the core values 
and behaviors resulting from a collective commitment by leaders and 
individuals to emphasize safety over competing goals to ensure 
protection of people and the environment. The Commission considers 
nuclear safety and nuclear security issues to be equally important in a 
positive safety culture. Thus, as part of this collective commitment, 
organizations should ensure that personnel in the safety and security 
sectors have 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. A safety culture that 
accomplishes this would include

[[Page 57084]]

all nuclear safety and security issues associated with NRC-regulated 
activities.
    Individuals and organizations performing or overseeing regulated 
activities involving nuclear materials bear the primary responsibility 
for safely handling and securing these materials. The Commission, as 
the regulatory agency, has an independent oversight role that reviews 
the performance of those individuals and organizations through its 
inspection and assessment processes, including their performance as it 
relates to areas important to safety culture.
    Experience has shown that certain personal and organizational 
traits are present in a positive safety culture. A trait, in this case, 
is a pattern of thinking, feeling, and behaving that emphasizes safety, 
particularly in goal conflict situations, e.g., production vs. safety, 
schedule vs. safety, and cost of the effort vs. safety. It should be 
noted that although the term ``security'' is not expressly included in 
these traits, safety and security are the primary pillars of the NRC's 
regulatory mission. Consequently, consideration of both safety and 
security issues, commensurate with their significance, is an underlying 
principle of this Statement of Policy. The traits of a positive safety 
culture include, but are not limited to: (1) Leadership Safety Values 
and Actions in which leaders demonstrate a commitment to safety in 
their decisions and behaviors; (2) Problem Identification and 
Resolution in which issues potentially impacting safety are promptly 
identified, fully evaluated, and promptly addressed and corrected 
commensurate with their significance; (3) Personal Accountability in 
which all individuals take personal responsibility for safety; (4) Work 
Processes in which the process of planning and controlling work 
activities is implemented so that safety is maintained; (5) Continuous 
Learning in which opportunities to learn about ways to ensure safety 
are sought out and implemented; (6) Environment for Raising Concerns in 
which a safety conscious work environment is maintained where personnel 
feel free to raise safety concerns without fear of retaliation, 
intimidation, harassment or discrimination; (7) Effective Safety 
Communication in which communications maintain a focus on safety; and 
(8) a Respectful Work Environment in which trust and respect permeate 
the organization. It is the Commission's expectation that all 
individuals and organizations, performing or overseeing regulated 
activities involving nuclear materials should take the necessary steps 
to promote a positive safety culture by fostering these traits as they 
apply to their organizational environments.

IV. Changes to the Initial Draft Statement of Policy

    Like the initial draft SOP, the revised draft SOP begins by 
indicating to whom the policy applies as a general matter. In the 
initial draft SOP, licensees and certificate holders are listed; 
however, earlier in the FRN, there is a footnote indicating that 
throughout the document, the phrase ``licensees and certificate 
holders'' includes licensees, certificate holders, permit holders, 
authorization holders, etc. The revised draft SOP refers to 
``individuals and organizations, performing or overseeing regulated 
activities involving nuclear materials,'' which includes vendors and 
suppliers of safety-related components. Additionally, the revised draft 
SOP notes the Commission's expectation that the Agreement States and 
other organizations interested in the safe use of nuclear materials 
also develop and maintain a positive safety culture within their 
regulated communities as well.
    The definition of safety culture in the initial draft SOP is based 
on the International Atomic Energy Agency (IAEA) definition of safety 
culture, modified to broaden its applicability to materials users and 
to include security. The definition of safety culture has been changed 
in the revised draft SOP to the definition that was developed during 
the February 2010 workshop. This definition is broad enough to apply to 
all individuals and organizations, performing or overseeing regulated 
activities involving nuclear materials. Additionally, the February 2010 
workshop definition does not include the term ``security.'' The revised 
definition resonated with the workshop panelists. Additionally, it was 
the preferred definition in the comments received on the initial draft 
policy statement and the comments received during several industry 
forums held after the February 2010 workshop. The initial draft SOP, 
like the revised draft SOP, discusses the importance of providing 
personnel in both the safety and security sectors with an appreciation 
for the importance of each. Both SOPs also discuss the importance of 
recognizing how closely intertwined safety and security activities are 
and the importance of integrating these activities so as not to 
diminish or adversely affect either. The initial draft SOP indicates 
areas that should receive the greatest attention as a matter of 
priority. The revised draft SOP is silent on this point because each 
entity should examine its specific regulated activities to determine 
the areas that should receive the greatest attention.
    Both SOPs stress the fact that those entities that use or provide 
services related to the use of radioactive materials bear the primary 
responsibility for safely handling and securing such materials; 
however, the revised draft SOP, as noted above, expands those entities 
to include individuals and organizations performing regulated 
activities to support the ability of the Agreement States to apply this 
SOP to their licensees. Both SOPs also point out that the NRC, as the 
regulatory agency, has an independent oversight role of those 
individuals and organizations through their inspection and assessment 
processes including their performance as it relates to areas important 
to safety culture.
    Based on responses to a question posed in the FRN containing the 
initial draft SOP, the revised draft SOP contains the traits (i.e., 
descriptions of areas important to safety culture). The November 2009 
FRN describes the traits in another section of the policy statement 
rather than in the actual Statement of Policy (SOP) section. The traits 
that are included in the revised draft SOP, while similar to those 
proposed by the NRC in the November 2009 FRN, are based on the traits 
developed by the February workshop panelists. Taking into consideration 
the public comments on the initial draft safety policy statement, the 
NRC staff revised the workshop traits to make them clearer but made no 
substantive changes. Additionally, the revised draft SOP contains a 
preamble to the traits explaining what is a trait, and a discussion of 
the use of the term ``security'' in the traits, noting that although 
not expressly included in the traits, consideration of both safety and 
security issues commensurate with their significance is an underlying 
principle of the SOP.
    The initial draft SOP also refers to the scope of the Commission's 
responsibilities as well as how it carries out these responsibilities. 
This paragraph was removed from the revised draft SOP to avoid 
confusing the SOP with a regulation; rather, the SOP provides the 
Commission's expectations regarding the applicability of this statement 
to individuals and organizations, performing or overseeing regulated 
activities involving nuclear materials.

V. Evaluation of Public Comments

    Sixty-six public comments were received on the initial draft policy

[[Page 57085]]

statement published in the November 2009 FRN. Several of the comments 
were statements of agreement on the information and/or draft SOP that 
was published in the November 2009 FRN. Although the NRC staff used 
these comments to validate work the staff had already completed, these 
comments did not require further clarification. Of the remaining public 
comments, most fell into one of three themes: (1) More guidance is 
needed on implementation issues; (2) should the term ``security'' be 
included in the definition and, if not, should there be a separate 
security policy statement; and, (3) how will the NRC use a policy 
statement (which is voluntary) to enforce implementation of safety 
culture.
(1) Implementation Comments
    Several of the comments requested clarification on the NRC's plans 
to implement the SOP. After the Commission has approved the policy 
statement, the Commission will issue an SRM to provide direction to the 
staff regarding next steps. The NRC offices that are responsible for 
overseeing regulated activities will assess their inspection and 
oversight programs to determine whether (and if so, how) to revise 
their programs based on the Commission's direction. The Commission is 
aware that there are many different settings in which the policy 
statement will be implemented and that implementation will be more 
complex in some settings than others. For example, as discussed above, 
the NRC's Reactor Oversight Program (ROP) already addresses safety 
culture in the inspection of nuclear power reactors. In addition, the 
power reactor community has ongoing programs and activities in place 
for assessing safety culture and implementing improvement strategies. 
This may not be the case with other categories of regulated activities, 
such as industrial radiography and medical use of isotopes. Variants 
such as these will be factored into the agency's approach and schedule 
for implementing the policy statement.
(2) Security Comments
    As noted above, the panelists at the February workshop aligned on a 
common definition of safety culture. That definition, however, differs 
from the draft definition proposed in the November 2009 FRN which 
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.'' The 
initial draft definition includes the terms ``safety'' and 
``security,'' underscoring the significance the Commission places on 
consideration of both within NRC's regulatory framework. In subsequent 
internal discussions and during the various outreach activities with 
stakeholders, the February workshop definition, which does not include 
the term ``security'', has been well received and thus, has been 
adopted in the revised draft SOP. The workshop definition is as 
follows: ``Nuclear safety culture is the core values and behaviors 
resulting from a collective commitment by leaders and individuals to 
emphasize safety over competing goals to ensure protection of people 
and the environment.'' Deletion of the term ``security'' was 
deliberate. The panelists believe that leaving it in the definition 
would cause unnecessary confusion, particularly for smaller regulated 
entities that do not have to consider the same security issues as a 
nuclear power plant or fuel processing facility, for example. Their 
position is that security, like radiation protection, safeguards, 
material control and accounting, physical protection, and emergency 
preparedness, falls under an overarching definition of safety and 
should not be singled out. These views on removing the term 
``security'' from the definition were also expressed by several members 
of a stakeholder panel during the Safety Culture Commission Briefing on 
March 30, 2010 (ML100950527).
    Likewise, the traits that are included in the revised draft SOP, 
while similar to those proposed by the NRC, do not include the term 
``security'' wherever the term ``safety'' is used. In recognition of 
the importance the agency places on security in a post ``9/11'' 
environment, the staff developed a preamble to the traits which points 
out that while the term ``security'' is not expressly included in each 
of the traits, safety and security are the primary pillars of the NRC's 
regulatory mission.
    Finally, unlike the initial draft safety culture policy statement, 
the revised traits are included in the revised draft SOP itself. The 
November 2009 FRN specifically asked whether commenters would prefer 
this approach. There was almost unanimous agreement that the traits 
should be included to clarify the SOP.
(3) Policy Statement vs. Regulation/Rule Comments
    Because public comments reflected some misunderstanding regarding 
the Commission's use of a policy statement rather than a regulation or 
rule, the following clarification is offered: The Commission may use a 
policy statement to address matters relating to activities that are 
within NRC jurisdiction and are of particular interest and importance 
to the Commission. Policy statements help to guide the activities of 
the NRC staff and can express the Commission's expectations. The NRC's 
Enforcement Policy, for example, describes the policy and procedures 
the agency intends to follow in initiating and reviewing enforcement 
actions in response to violations of NRC requirements.
    Policy statements are not regulations/rules and are not accorded 
the status of a regulation/rule within the meaning of the 
Administrative Procedure Act (Pub. L. 79-404), the primary goal of 
which is to ensure that agencies observe procedural due process (i.e., 
fairness), in conducting their regulatory and administrative affairs. 
For example, Agreement States that are responsible for overseeing 
materials licensees are not required to implement the elements of a 
policy statement because such statements, unlike NRC regulations, are 
not a matter of compatibility. Additionally, policy statements cannot 
be considered binding upon, or enforceable against, NRC or Agreement 
State licensees and certificate holders.
    While the option to consider rulemaking exists, the NRC believes 
that, at this time, developing a policy statement is a more effective 
way to engage stakeholders.

Additional Recommendations Based on Public Comments

    Based on its evaluation of the public comments, the NRC staff made 
several additional recommendations. These recommendations have been 
included in the revised draft SOP or are addressed elsewhere in this 
FRN.
    <bullet> In SRM-SECY-09-0075, the Commission directed the staff to 
consider incorporating vendors and suppliers of safety related 
components in the safety culture policy statement. Although there is 
strong support for doing so, some stakeholders have raised 
implementation issues. While implementation issues (particularly in 
cases where such vendors and suppliers are outside of NRC jurisdiction) 
may be complicated, most comments indicated that vendors and suppliers 
of safety-related components should be developing and maintaining a 
positive safety culture in their organizations for the same reasons 
that NRC licensees and certificate holders should be doing so. Thus, 
the revised draft SOP indicates that it is applicable to vendors and 
suppliers of safety-related components.
    <bullet> Because of the emphasis that the public comments place on 
strong

[[Page 57086]]

leadership, the NRC staff recommended moving the trait ``Leadership 
Safety Values and Actions'' to the top of the traits list to give it 
visual prominence.
    <bullet> Several comments indicated that there should be a 
discussion of complacency in the SOP. Complacency can occur because of 
long term success and repetition. Although this is already indirectly 
addressed in the traits (e.g., Effective Safety Communication and 
Personal Accountability are traits that prevent complacency), the NRC 
staff recommended further discussion of complacency in the revised 
draft SOP. The NRC is asking for comments as to whether it is useful to 
add a discussion on this aspect of safety culture to the SOP.

VI. Questions for Which NRC Is Seeking Input

    (1) The revised definition of Nuclear Safety Culture is: ``Nuclear 
Safety Culture is the core values and behaviors resulting from a 
collective commitment by leaders and individuals to emphasize safety 
over competing goals to ensure protection of people and the 
environment.'' Should this be retained, as currently written, or should 
it be revised?
    (2) Does including the safety culture traits in the SOP itself 
clarify your understanding of what the Commission means by a positive 
safety culture? If not, what additional guidance do you think is 
needed?
    (3) Does the revised draft SOP provide a clear statement of the 
NRC's expectations that the regulated community should maintain a 
safety culture that includes balanced consideration of safety and 
security? If not, what changes or additions should be made?
    (4) Should a discussion regarding complacency be added to the SOP 
and/or to the traits that describe areas important to safety?
    (5) In late August 2010, the Institute of Nuclear Power Operations 
(INPO) completed a validation study to assess the extent to which the 
factors that emerged from analyzing responses to a safety culture 
survey match the traits that were identified during the February 2010 
workshop. Only individuals working at nuclear reactors participated in 
the survey.
    The study provides general support for the traits developed at the 
workshop; however, the study provides a slightly different grouping. 
Under the validation study, there are nine traits: (1) Management 
Responsibility/Commitment to Safety; (2) Willingness to Raise Concerns; 
(3) Decision-making; (4) Supervisor Responsibility for Safety; (5) 
Questioning Attitude; (6) Safety Communication; (7) Personal 
Responsibility for Safety; (8) Prioritizing Safety; and (9) Training 
Quality. Four of these are consistent with the eight traits developed 
by the workshop participants, i.e., Management Responsibility is 
consistent with Leadership Safety Values and Actions; Willingness to 
Raise Concerns relates to Environment for Raising Concerns; Safety 
Communication relates to Effective Safety Communication; and Personal 
Responsibility for Safety is consistent with Personal Accountability. 
The remaining five traits identified in the study, i.e., Decision-
making, Supervisor Responsibility for Safety, Questioning Attitude, 
Prioritizing Safety, and Training Quality, are not as closely related 
(although they are not completely dissimilar). This is new information. 
The NRC is seeking stakeholder comments on this information though the 
FRN and through the public meeting scheduled for September 28 in Las 
Vegas.
    To ensure efficient consideration of your comments, if you are 
responding to a specific question, please identify it by number with 
your comment. 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.

    For the Nuclear Regulatory Commission.

    Dated at Rockville, Maryland, this 10th day of Sept, 2010.
Roy P. Zimmerman,
Director, Office of Enforcement.
[FR Doc. 2010-23249 Filed 9-16-10; 8:45 am]
BILLING CODE 7590-01-P


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