Policy Statement on Adequacy and Compatibility of Agreement State Programs; Statement of Principles and Policy for the Agreement State Program, 33122-33132 [2013-13066]
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33122
Federal Register / Vol. 78, No. 106 / Monday, June 3, 2013 / Notices
implements this statutory prohibition,
providing that any person who is a
citizen, national, or agent of a foreign
country, or any corporation, or other
entity which the Commission knows or
has reason to believe is owned,
controlled, or dominated by an alien, a
foreign corporation, or an foreign
government, shall be ineligible to apply
for and obtain a license. (emphasis
supplied).
With respect to combined license
applications, the Commission’s
regulations under 10 CFR 52.75(a)
further state any person (except one
excluded by § 50.38 of the
Commission’s regulations) may file an
application for a combined license for a
nuclear power facility with the Director,
Office of New Reactors or Director,
Office of Nuclear Reactor Regulation, as
appropriate.
On March 11, 2013, in SRM–12–0168,
‘‘Calvert Cliffs 3 Nuclear Project, LLC &
UniStar Nuclear Operating Services,
LLC (Calvert Cliffs Nuclear Power Plant,
Unit 3), Docket No. 52–016–COL,
Petition for Review of LBP–12–19,’’ the
Commission directed the staff to
provide a fresh assessment on issues
relating to FOCD including
recommendations on any proposed
modifications to guidance or practice on
FOCD that may be warranted.
Specifically, the Commission is
looking for comments on the limitation
on FOCD as contained in Section 103d.
of the AEA and the potential to satisfy
statutory objectives through an
integrated review of foreign ownership,
control, or domination issues involving
up to and including 100 percent indirect
foreign ownership; criteria for assessing
proposed plans or actions to negate
direct or indirect foreign ownership or
foreign financing of more than 50
percent but less than 100 percent, and
the adequacy of guidance on these
criteria; the availability of alternative
methods such as license conditions for
resolving—following issuance of a
combined license—FOCD; and the
agency’s interpretation of the statutory
meaning of ‘‘ownership,’’ and how that
definition applies in various contexts,
such as total or partial foreign
ownership of a licensee’s parent, coowners, or owners who are licensed to
own but not to possess or operate a
facility.
It is the desire of the NRC to receive
comments of a high quality from all
stakeholders on issues relating to FOCD.
The 60-day comment period is
reasonable and is not anticipated to
affect NRC deadlines. The allotted time
will allow adequate time for the NRC to
review comments, and organize and
conduct a Category 3 Public Meeting on
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June 19, 2013, to facilitate additional
stakeholder engagement and input.
For the Nuclear Regulatory Commission.
Dated at Rockville, Maryland, this 21st day
of May 2013.
Christopher Regan,
Chief, Financial Analysis and International
Projects Branch, Division of Inspection and
Regional Support, Office of Nuclear Reactor
Regulation.
[FR Doc. 2013–12596 Filed 5–31–13; 8:45 am]
BILLING CODE 7590–01–P
NUCLEAR REGULATORY
COMMISSION
[NRC–2013–0081]
Policy Statement on Adequacy and
Compatibility of Agreement State
Programs; Statement of Principles and
Policy for the Agreement State
Program
Nuclear Regulatory
Commission.
ACTION: Policy statements; draft
revisions and request for comment.
AGENCY:
The U.S. Nuclear Regulatory
Commission (NRC) is proposing
revisions to its policy statements on
Agreement State Programs. Both the
‘‘Policy Statement on Adequacy and
Compatibility of Agreement State
Programs’’ and the ‘‘Statement of
Principles and Policy for the Agreement
State Program’’ have been revised to add
information on security of radioactive
materials and incorporate changes in the
NRC’s policies and procedures since the
last revision in 1997. In addition to
requesting comments on the revisions
made to the policy statements, the NRC
is specifically requesting comments on
(1) Compatibility Category B in the
‘‘Policy Statement on Adequacy and
Compatibility of Agreement State
Programs,’’ (2) consideration of a
performance based approach in
determining Agreement State
compatibility, and (3) performance
based metrics in the adequacy
determination of an Agreement State
program.
SUMMARY:
Submit comments by August 19,
2013. 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.
ADDRESSES: You may submit comment
by any of the following methods (unless
this document describes a different
method for submitting comments on a
specific subject):
• Federal Rulemaking Web site: Go to
https://www.regulations.gov and search
DATES:
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for Docket ID NRC–2013–0081. Address
questions about NRC dockets to Carol
Gallagher; telephone: 301–492–3668;
email: Carol.Gallagher@nrc.gov. For
technical questions, contact the
individual(s) listed in the FOR FURTHER
INFORMATION CONTACT section of this
document.
• Email comments to:
Rulemaking.Comments@nrc.gov. If you
do not receive an automatic email reply
confirming receipt, then contact us at
301–415–1677.
• Fax comments to: Secretary, U.S.
Nuclear Regulatory Commission at 301–
415–1101.
• Mail comments to: Secretary, U.S.
Nuclear Regulatory Commission,
Washington, DC 20555–0001, ATTN:
Rulemakings and Adjudications Staff.
• Hand deliver comments to: 11555
Rockville Pike, Rockville, Maryland
20852, between 7:30 a.m. and 4:15 p.m.
(Eastern Time) Federal workdays;
telephone: 301–415–1677.
For additional direction on accessing
information and submitting comments,
see ‘‘Accessing Information and
Submitting Comments’’ in the
SUPPLEMENTARY INFORMATION section of
this document.
FOR FURTHER INFORMATION CONTACT: Lisa
Dimmick, Office of Federal and State
Materials and Environmental
Management Programs, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555–0001; telephone: 301–415–
0694, email: Lisa.Dimmick@nrc.gov.
SUPPLEMENTARY INFORMATION:
I. Accessing Information and Submitting
Comments
II. Background
III. Discussion
IV. Proposed Revision to Policy Statement on
Adequacy and Compatibility of
Agreement State Programs
V. Proposed Revision to Statement of
Principles and Policy for the Agreement
State Program
VI. Topics for Additional Comment
VII. Paperwork Reduction Act
I. Accessing Information and
Submitting Comments
A. Accessing Information
Please refer to Docket ID NRC–2013–
0081 when contacting the NRC about
the availability of information for the
proposed revisions of the policy
statements. You may access information
related to the proposed revisions of the
policy statements, which the NRC
possesses and is publicly available, by
any of the following methods:
• Federal Rulemaking Web site: Go to
https://www.regulations.gov and search
for Docket ID NRC–2013–0081.
• NRC’s Agencywide Documents
Access and Management System
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(ADAMS): You may access public
documents online in the NRC Library at
https://www.nrc.gov/reading-rm/
adams.html. To begin the search, select
‘‘ADAMS Public Documents’’ and then
select ‘‘Begin Web-based ADAMS
Search.’’ For problems with ADAMS,
please contact the NRC’s Public
Document Room (PDR) reference staff at
1–800–397–4209, 301–415–4737, or by
email to pdr.resource@nrc.gov. The
ADAMS accession number for each
document referenced in this notice (if
that document is available in ADAMS)
is provided the first time that a
document is referenced.
• NRC’s PDR: You may examine and
purchase copies of public documents at
the NRC’s PDR, Room O1–F21, One
White Flint North, 11555 Rockville
Pike, Rockville, Maryland 20852.
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B. Submitting Comments
Please include Docket ID NRC–2013–
0081 in the subject line of your
comment submission, in order to ensure
that the NRC is able to make your
comment submission available to the
public in this docket.
The NRC cautions you not to include
identifying or contact information that
you do not want to be publicly
disclosed in your comment submission.
The NRC will post all comment
submissions at https://
www.regulations.gov as well as enter the
comment submissions into ADAMS.
The NRC does not routinely edit
comment submissions to remove
identifying or contact information.
If you are requesting or aggregating
comments from other persons for
submission to the NRC, then you should
inform those persons not to include
identifying or contact information that
they do not want to be publicly
disclosed in their comment submission.
Your request should state that the NRC
does not routinely edit comment
submissions to remove such information
before making the comment
submissions available to the public or
entering the comment submissions into
ADAMS.
II. Background
On August 25, 1993, the Commission
requested the NRC staff to recommend
improvements to the NRC’s Agreement
State Program to assure adequate
protection of public health and safety.
Among these improvements, the NRC
staff, with participation from Agreement
State representatives, developed two
policy statements. The policy
statements are entitled ‘‘Policy
Statement on Adequacy and
Compatibility of Agreement State
Programs’’ and ‘‘Statement of Principles
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and Policy for the Agreement State
Program.’’ The Commission approved
both policy statements on June 29, 1995,
but deferred their implementation until
all implementing procedures were
completed and approved by the
Commission. These policy statements
became effective on September 3, 1997
(62 FR 46517).
In Staff Requirements Memorandum
(SRM), ‘‘SECY–10–0105, Final Rule:
Limiting the Quantity of Byproduct
Material in a Generally Licensed
Device’’ (ADAMS Accession No.
ML103360262) dated December 2, 2010,
the Commission directed the NRC staff
to update the Commission’s ‘‘Policy
Statement on Adequacy and
Compatibility of Agreement State
Programs’’ and associated guidance
documents to include both safety and
source security considerations in the
determination process. Because
Agreement State adequacy and
compatibility are key components of the
Integrated Materials Performance
Evaluation Program (IMPEP) process,1
the Commission’s Policy Statement on
the ‘‘Statement of Principles and Policy
for the Agreement State Program’’ is
being revised concurrently. Two
Working Groups operating in
accordance with NRC Management
Directive 5.3, ‘‘Agreement State
Participation in Working Groups,’’ dated
August 22, 2007 (ADAM Accession No.
ML070940610), are drafting the
revisions to these policy statements. The
two Working Groups met concurrently
and periodically interfaced in
developing the proposed revisions. The
revisions include adding information on
security of radioactive materials and
updating the policy statements to reflect
subsequent changes in the NRC policies
and procedures.
III. Discussion
The Commission tasked the staff with
updating the Commission’s Policy
Statement, ‘‘Policy Statement on
Adequacy and Compatibility of
Agreement State Programs,’’ and
associated guidance, to include both
safety and source security in the
determination process. The Policy
Statement as issued in 1997 continues
to remain relevant and effectively serves
the mission of the agency. However, the
staff concluded that the ‘‘Policy
Statement on Adequacy and
Compatibility of Agreement State
Programs’’ and the ‘‘Statement of
Principles and Policy for the Agreement
1 The NRC developed the IMPEP process to
evaluate the adequacy and compatibility of
Agreement State Programs and the adequacy of the
NRC’s nuclear materials program activities.
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State Program’’ both required revision to
meet the intent of the SRM by clarifying
that security is part of the agency’s
health and safety mission and update
the policy statements to include current
policies, procedures, and practices.
Following the events of September 11,
2001, the NRC’s regulatory oversight
was enhanced. Additional security
measures were developed and
implemented. While safety and source
security have always been inherent to
the protection of public health and
safety, the Working Groups recognized
that the two policy statements needed to
specifically acknowledge that the NRC
and Agreement State oversight of these
enhanced security measures should not
be confused with the NRC’s mission to
promote the common defense and
security. The Working Groups revised
the purpose sections of the policy
statements to indicate that public health
and safety includes physical protection
of ‘‘agreement material.’’
The two Working Groups also
reconciled a difference in terminology
in the policy statements as they were
originally published. The ‘‘Policy
Statement on Adequacy and
Compatibility of Agreement State
Programs’’ used the term ‘‘agreement
material’’ to refer to byproduct, source,
and small quantities of special nuclear
material as defined in Section 274b. of
the Atomic Energy Act (AEA) of 1954,
as amended. The ‘‘Statement of
Principles and Policy for the Agreement
State Program’’ used the term ‘‘AEA
material’’ to describe the same material.
While the terms ‘‘agreement material’’
and ‘‘AEA material’’ are generally
viewed as synonymous, using different
terms in the policies may be construed
as an indication that the NRC intended
the terms to have different meanings.
The Working Groups decided to use the
term ‘‘agreement material’’ throughout
both policy statements.
Policy Statement on Adequacy and
Compatibility of Agreement State
Programs
As explained in greater detail in
Section VI, ‘‘Topics for Additional
Comment,’’ of this document, the NRC
is requesting comments on the language
used to describe and define
Compatibility Category B. The language
from the 1997 version of the Policy
Statement was left in place in the draft
revision so that the input requested
could be based on the description
currently used when making a
determination of Compatibility Category
B. For Compatibility Category C, the
Working Group felt it was important to
clarify that program elements and
regulations assigned this category of
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compatibility could be more restrictive
than the equivalent NRC program
element or regulation. Additionally, the
NRC is requesting comments on what
types of program elements should be
designated as a Compatibility Category
B. The NRC is also requesting comment
as to whether the number of
Compatibility Category B program
element should be limited.
The NRC expects to hold two public
meetings during the public comment
period. The agendas for the two public
meetings, including the dates and
locations, will be posted on the NRC’s
public meeting schedule Web site at
https://www.nrc.gov/public-involve/
public-meetings/index.cfm.
Statement of Principles and Policy for
the Agreement State Program
Several changes were made
throughout the Policy Statement to
demonstrate a clear connection between
public health, safety, and security. The
NRC and Agreement State radiation
control programs maintain regulatory
oversight for the safe and secure
handling of nuclear materials. These
programs have always included the
security of nuclear materials as an
integral part of their health and safety
mission as it relates to minimizing the
risk of exposure to workers and the
public. Throughout the 1997 Policy
Statement, the phrase ‘‘safe use’’ of
material was used. To impart the
concept that security is a necessary
component of public health and safety,
the phrase ‘‘safe use’’ of material was
replaced with ‘‘safe and secure use’’ of
material.
Several updates were made to align
the Policy Statement with current
practices under IMPEP. The Working
Group expanded the text addressing the
actions taken by the NRC as a result of
program review findings to include
options to address performance such as
monitoring, heightened oversight,
probation, suspension, and termination.
IV. Proposed Revision to Policy
Statement on Adequacy and
Compatibility of Agreement State
Programs
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Purpose
Section 274 of the AEA of 1954, as
amended, provides for a Federal-State
regulatory framework for the control of
byproduct, source, and small quantities
of special nuclear material (hereinafter
termed ‘‘agreement material’’) as
identified by Section 274b. of the AEA.
The NRC, by agreement with a State
under Section 274 of the AEA,
relinquishes its regulatory authority in
certain areas and allows the State
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Government to assume that regulatory
authority, as long as the State program
is adequate to protect public health and
safety and compatible with the
Commission’s 2 program. For the
purpose of this Policy Statement,
‘‘public health and safety’’ includes
physical protection of agreement
material.
Section 274 further directs the
Commission to periodically review State
programs to ensure compliance with the
provisions of Section 274. This Policy
Statement presents the NRC’s policy for
determining the adequacy and
compatibility of Agreement State
programs established in accordance
with Section 274. This Policy Statement
clarifies the meaning and use of the
terms ‘‘adequate to protect public health
and safety’’ and ‘‘compatible with the
Commission’s regulatory program’’ as
applied to the Agreement State program.
The Policy Statement also describes the
general framework that will be used to
identify those program elements that
Agreement State programs should
implement to adequately protect public
health and safety and to be compatible
with the Commission’s regulatory
program. For the purposes of this Policy
Statement, ‘‘program element’’ means
any component or function of a
radiation control regulatory program,
including regulations and/or other
legally binding requirements imposed
on regulated persons, which contributes
to implementation of that program.
Finally, the Policy Statement reflects
principles discussed in the
Commission’s ‘‘Statement of Principles
and Policy for the Agreement State
Program,’’ which should be considered
in conjunction with this Policy
Statement.
This Policy Statement is solely
guidance for the Commission and the
Agreement States in the implementation
of the Agreement State program. This
Policy Statement does not itself impose
legally binding requirements on the
Agreement States. In addition, nothing
in this Policy Statement expands the
legal authority of Agreement States
beyond that already granted to them by
Section 274 of the AEA and other
relevant legal authority. Nor does this
Policy Statement diminish or constrain
the NRC’s authority under the AEA.
Implementation procedures adopted
under this Policy Statement shall be
consistent with the legal authorities of
2 For the purposes of this Policy Statement the
definition of Commission is equivalent to Title 10
of the Code of Federal Regulations: Commission
means the five members of the NRC or a quorum
thereof sitting as a body, as provided by Section 201
of the Energy Reorganization Act of 1974, as
amended.
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the Commission and the Agreement
States.
Background
The terms ‘‘adequate’’ and
‘‘compatible’’ represent fundamental
concepts in the Agreement State
program authorized in 1959 by Section
274 of the AEA. Subsection 274d. states
that the Commission shall enter into an
Agreement under subsection 274b.,
relinquishing the NRC’s regulatory
authority over certain materials in a
State, provided that the State’s program
is adequate to protect public health and
safety and is compatible, in all other
respects, with the Commission’s
regulatory program. Subsection 274g.
authorizes and directs the Commission
to cooperate with States in the
formulation of standards to assure that
State and Commission standards will be
coordinated and compatible. Subsection
274j(1) requires the Commission to
review periodically the Agreements and
actions taken by States under the
Agreements to ensure compliance with
the provisions of Section 274. Therefore,
the Commission must review the actions
taken by States under the Agreements to
ensure that the programs continue to be
adequate to protect public health and
safety and compatible with the
Commission’s program.
In identifying those program elements
for adequate and compatible programs,
or any changes thereto, the NRC staff
will seek the advice of the Agreement
States. The Commission will consider
such advice in its final decision.
Discussion
Section 274 of the AEA requires that
Agreement State programs be both
‘‘adequate to protect the public health
and safety’’ and ‘‘compatible with the
Commission’s program.’’ In accordance
with Section 274 of the AEA, an
Agreement State program should
provide for an acceptable level of
protection of public health and safety in
an Agreement State (the ‘‘adequacy’’
component). The Agreement State
should also ensure that its program
serves an overall nationwide interest in
radiation protection (the
‘‘compatibility’’ component).
Program elements for adequacy focus
on the protection of public health and
safety within a particular State while
program elements for compatibility
focus on the impacts of an Agreement
State’s regulation of agreement material
on a nationwide basis or its potential
effects on other jurisdictions. Many
program elements for compatibility also
impact public health and safety;
therefore, they may also be considered
program elements for adequacy.
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1. Adequacy
An ‘‘adequate’’ program should
include those program elements not
required for compatibility but necessary
to maintain an acceptable level of
protection of public health and safety
within an Agreement State. These
program elements make up the category
Health and Safety. An Agreement State’s
radiation control program is adequate to
protect public health and safety if
administration of the program provides
reasonable assurance of protection of
public health and safety in regulating
the use of agreement material. The level
of protection afforded by the program
elements of the NRC’s materials
regulatory program is presumed to be
that which is adequate to provide a
reasonable assurance of protection of
public health and safety. Therefore, the
overall level of protection of public
health and safety provided by a State
program should be equivalent to, or
greater than, the level provided by the
NRC program. To provide reasonable
assurance of protection of public health
and safety, an Agreement State program
should contain the five essential
program elements, identified in Sections
A. through E., that the Commission will
use to define the scope of its review of
the program. The Commission will also
consider, when appropriate, other
program elements of an Agreement State
that appear to affect the program’s
ability to provide reasonable assurance
of public health and safety protection.
Such consideration will occur only if
concerns arise.
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A. Legislation and Legal Authority
State statutes should:
(1) Authorize the State to establish a
program for the regulation of agreement
material and provide authority for the
assumption of regulatory responsibility
under an Agreement with the
Commission;
(2) Authorize the State to promulgate
regulatory requirements necessary to
provide reasonable assurance of
protection of public health and safety;
(3) Authorize the State to license,
inspect, and enforce legally binding
requirements such as regulations and
licenses; and
(4) Be otherwise consistent with
applicable Federal statutes.
In addition, the State should have
existing legally enforceable measures
such as generally applicable rules,
license provisions, or other appropriate
measures, necessary to allow the State
to ensure adequate protection of public
health and safety in the regulation of
agreement material in the State. For
those items that have significant health
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and safety implications, the NRC shall
identify legally binding requirements
that should be adopted by Agreement
States. The NRC expects that there will
be a limited number of such
requirements. In adopting such
requirements, Agreement States should
adopt the essential objectives of those of
the Commission.
B. Licensing
The State should conduct appropriate
evaluations of proposed uses of
agreement material, before issuing a
license, to assure that the proposed
licensee’s operations can be conducted
safely and securely. Licenses should
provide for reasonable assurance of
public health and safety protection in
relation to the licensed activities.
C. Inspection and Enforcement
The State should periodically conduct
inspections of licensed activities
involving agreement material to provide
reasonable assurance of safe licensee
operations and to determine compliance
with its regulatory requirements. When
determined to be necessary by the State,
the State should take timely
enforcement action against licensees
through legal sanctions authorized by
State statutes and regulations.
D. Personnel
The State should be staffed with a
sufficient number of qualified personnel
to implement its regulatory program for
the control of agreement material.
E. Incidents and Allegations
The State should respond to and
conduct timely inspections or
investigations of incidents, reported
events, and allegations involving
agreement material within the State’s
jurisdiction to provide reasonable
assurance of protection of public health
and safety.
1. Compatibility
A ‘‘compatible’’ program should
consist of those program elements
necessary to meet a larger nationwide
interest in promoting an orderly pattern
of regulation of radiation protection.
Those program elements are generally
limited to areas of regulation involving
radiation protection standards and
activities with significant transboundary
implications. An Agreement State
radiation control program is compatible
with the Commission’s regulatory
program when its program does not
create conflicts, duplications, gaps, or
other conditions that would jeopardize
an orderly pattern in the regulation of
agreement material on a nationwide
basis. For purposes of compatibility, the
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State should address the following
Categories A, B, and C:
A. Category A—Basic Radiation
Protection Standards
For purposes of this Policy Statement,
this category includes ‘‘basic radiation
protection standards’’ meaning dose
limits, concentration and release limits
related to radiation protection in Part 20
of Title 10 of the Code of Federal
Regulations (10 CFR), that are generally
applicable, and the dose limits in 10
CFR 61.41.3 Also included in this
category are a limited number of
definitions, signs, labels, and scientific
terms that are necessary for a common
understanding of radiation protection
principles among licensees, regulatory
agencies, and members of the public.
Such State standards should be
essentially identical to those of the
Commission, unless Federal statutes
provide the State authority to adopt
different standards. Basic radiation
protection standards do not include
constraints or other limits below the
level associated with ‘‘adequate
protection’’ that take into account
permissible balancing considerations
such as economic cost and other factors.
B. Category B—Program Elements With
Significant Transboundary Implications
The Commission will limit this
category to a small number of program
elements (e.g., transportation
regulations and sealed source and
device registration certificates) that have
significant transboundary implications.
Agreement State program elements
should be essentially identical to those
of the Commission.
C. Category C—Other Commission
Program Elements
These are other Commission program
elements that are important for an
Agreement State to have in order to
avoid conflicts, duplications, gaps, or
other conditions that would jeopardize
an orderly pattern in the regulation of
agreement material on a nationwide
basis. Such Agreement State program
elements should embody the essential
objective of the corresponding
Commission program elements.
Agreement State program elements may
be more restrictive than Commission
program elements; however, they
3 The Commission will implement this category
consistent with its earlier decision in the low-level
waste area to allow Agreement States flexibility to
establish pre-closure operational release limit
objectives, as low as is reasonably achievable goals
or design objectives at such levels as the State may
deem necessary or appropriate, as long as the level
of protection of public health and safety is at least
equivalent to that afforded by Commission
requirements.
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should not be so restrictive as to
prohibit a licensed activity.
D. Category D—Program Elements Not
Required for Compatibility
An Agreement State has the flexibility
to adopt and implement program
elements within the State’s jurisdiction
that are not addressed by the NRC, or
program elements not required for
compatibility (i.e., those NRC program
elements not assigned a Compatibility
A, B, or C). However, such program
elements of an Agreement State relating
to agreement material should:
(1) Be compatible with those of the
Commission (i.e., should not create
conflicts, duplications, gaps, or other
conditions that would jeopardize an
orderly pattern in the regulation of
agreement material on a nationwide
basis);
(2) Not preclude, or effectively
preclude, a practice 4 in the national
interest without an adequate public
health and safety or environmental basis
related to radiation protection; and
(3) Not preclude, or effectively
preclude, the ability of the Commission
to evaluate the effectiveness of the NRC
and Agreement State programs for
agreement material with respect to
protection of public health and safety.
E. Category NRC—Areas of Exclusive
NRC Regulatory Authority
These are program elements that
address areas of regulation that cannot
be relinquished to Agreement States
pursuant to the AEA or provisions of
Title 10 of the Code of Federal
Regulations. However, an Agreement
State may inform its licensees of these
NRC provisions through a mechanism
that is appropriate under the State’s
administrative procedure laws as long
as the State adopts these provisions
solely for the purposes of notification,
and does not exercise any regulatory
authority as a result.
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Summary and Conclusions
To foster and enhance a coherent and
consistent nationwide program for the
regulation of agreement material, the
Commission encourages Agreement
States to adopt and implement program
elements that are patterned after those
adopted and implemented by the
Commission. However, the fact that an
Agreement State’s program is
4 For the purposes of this Policy Statement,
‘‘practice’’ means a use, procedure, or activity
associated with the application, possession, use,
storage, or disposal of agreement material. The term
‘‘practice’’ is used in a broad and encompassing
manner in this Policy Statement but does not
include economic considerations. The term
encompasses both general and specific activities
involving the use of agreement materials.
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compatible with that of the Commission
does not affect that State’s obligation to
maintain an adequate program as
described in this Policy Statement.
By adopting the criteria for adequacy
and compatibility as discussed in this
Policy Statement, the Commission will
provide Agreement States a broad range
of flexibility in the administration of
individual programs. Recognizing the
fact that Agreement States have
responsibilities for radiation sources
other than agreement material, the
Commission allows Agreement States to
fashion their programs so as to reflect
specific State needs and preferences.
The Commission will minimize the
number of NRC regulatory requirements
that the Agreement States will be
requested to adopt in an identical
manner to maintain compatibility. The
expectation is that these requirements
will be limited. Requirements in these
compatibility categories allow the
Commission to ensure that an orderly
pattern for the regulation of agreement
material exists nationwide. The
Commission believes that this approach
achieves a proper balance between the
need for Agreement State flexibility and
the need for coordinated and compatible
regulation of agreement material across
the country.
V. Proposed Revisions to Statement of
Principles and Policy for the Agreement
State Program
A. Statement of Principles and Policy
for the Agreement State Program
Purpose
The purpose of this Statement of
Principles and Policy for the Agreement
State Program is to clearly describe the
respective roles and responsibilities of
the NRC and States in the
administration of programs carried out
under Section 274 of the AEA of 1954,
as amended. Section 274 provides broad
authority for the NRC to establish
Federal and State cooperation in the
administration of regulatory programs
for the protection of public health and
safety in the industrial, medical,
commercial, and research uses of
nuclear materials.
This Policy Statement addresses the
Federal-State interaction under the
AEA: (1) to establish and maintain
agreements with States under Section
274b. that provide for discontinuance by
the NRC, and the assumption by the
State, of responsibility for
administration of a regulatory program
for the safe and secure use of byproduct,
source, and small quantities of special
nuclear material; and (2) ensure that
post-agreement interactions among the
NRC and Agreement State radiation
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control programs are coordinated,
compatible, and continue to provide
adequate protection of public health and
safety.
Section 274 of the AEA provides for
a special Federal-State regulatory
framework for the control of byproduct,
source, and small quantities of special
nuclear material as identified by Section
274b. of the AEA. The NRC, by
agreement with a State, relinquishes its
authority under Section 274 of the AEA
over practices involving some or all of
these materials. The material over
which the State receives regulatory
authority under such agreements is
hereinafter termed ‘‘agreement
material.’’
The NRC and Agreement State
radiation control programs maintain
regulatory oversight for the safe and
secure handling, use, and storage of
agreement material. These programs
have always included the security of
nuclear materials as an integral part of
their health and safety mission as it
relates to minimizing the risk of
exposure to workers and the public.
Following the events of September 11,
2001, the NRC’s regulatory oversight has
included developing and implementing
enhanced security measures. For the
purposes of this policy statement,
public health and safety includes these
enhanced security measures.
This Policy Statement establishes
principles, objectives, and goals that the
Commission expects will be reflected in
the implementing guidance and
programs of the NRC and Agreement
States to meet their respective program
responsibilities and that should be
achieved in the administration of these
programs.
This Policy Statement is intended
solely as guidance for the Commission
and the Agreement States in the
implementation of the Agreement State
program. This Policy Statement does not
itself impose legally binding
requirements on the Agreement States.
In addition, nothing in this Policy
Statement expands the legal authority of
Agreement States beyond that already
granted to them by Section 274 of the
AEA and other relevant legal authority.
Implementation procedures adopted
pursuant to this Policy Statement shall
be consistent with the legal authorities
of the Commission and the Agreement
States.
Statement of Legislative Intent
The AEA did not initially specify a
role for the States in regulating the use
of nuclear materials. Many States were
concerned as to what their
responsibilities in this area might be
and expressed interest in seeing that the
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boundaries of Federal and State
authority were clearly defined. This
need for clarification was particularly
important in view of the fact that
although the Federal Government
retained sole responsibility for
protecting public health and safety from
the radiation hazards of byproduct,
source, and special nuclear material, the
responsibility for protecting the public
from the radiation hazards of other
sources such as x-ray machines and
radium had been borne for many years
by the States.
Consequently, in 1959 Congress
enacted Section 274 of the AEA to
establish a statutory framework under
which States could assume certain
regulatory jurisdiction over byproduct,
source, and special nuclear material in
quantities less than a critical mass. The
primary purpose of the legislation was
to authorize the Commission to
relinquish its regulatory authority over
the use of these materials and for
assumption of this authority by the
States. The Commission retained
regulatory authority over the licensing
of certain facilities and activities such as
nuclear reactors, larger quantities of
special nuclear material, the export and
import of nuclear materials, and matters
related to common defense and security.
In considering the legislation,
Congress recognized that the Federal
Government would need to assist the
States to ensure that they developed the
capability to exercise their regulatory
authority in a competent and effective
manner. Accordingly, the legislation
authorized the Commission to provide
training and other services to State
officials and employees. However, in
rendering this assistance, Congress did
not intend that the Commission would
provide any grants to a State for the
administration of a State regulatory
program. This was fully consistent with
the objectives of Section 274 to qualify
States to assume independent regulatory
authority over certain defined areas of
regulatory jurisdiction and to permit the
Commission to discontinue its
regulatory responsibilities in those
areas.
In order to relinquish its authority to
a particular State, the Commission must
find that program is compatible with the
Commission’s program for the
regulation of agreement materials and
that the State program is adequate to
protect public health and safety. In
addition, the Commission has an
obligation, pursuant to Section 274j. of
the AEA, to review existing Agreement
State programs periodically to ensure
continued adequacy and compatibility.
Section 274j. of the AEA provides that
the NRC may terminate or suspend all
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or part of its agreement with a State if
the Commission finds that such
termination is necessary to protect
public health and safety or that the State
has not complied with the provisions of
Section 274j. In these cases, the
Commission must offer the State
reasonable notice and opportunity for a
hearing. In addition, the Commission
may temporarily suspend all or part of
an agreement in the case of an
emergency situation.
B. Principles of Program
Implementation and Program
Assessment
The NRC is responsible for ensuring
that the regulatory programs of the NRC
and the Agreement States collectively
establish a coherent nationwide effort
for the control of agreement material.
The basic elements of such regulatory
programs include principles of good
regulation in program administration
and the ability to assess program
performance on a consistent and
systematic basis; the ability to ensure
adequate protection of public health and
safety including security of these
nuclear materials; compatibility in areas
of national interest; and sufficient
flexibility to accommodate local needs
and conditions. Each of these elements
is reflected and addressed in specific
sections of this Policy Statement.
1. Good Regulation Principles
In 1991, the Commission adopted
’’Principles of Good Regulation’’ to
serve as a guide to both agency decision
making and to individual behavior as
NRC employees. There are five
Principles of Good Regulation:
independence, openness, efficiency,
clarity, and reliability. Adherence to
these principles has helped to ensure
that the NRC’s regulatory activities have
been of the highest quality, appropriate,
and consistent. The ’’Principles of Good
Regulation’’ recognize that strong,
vigilant management and a desire to
improve performance are prerequisites
for success, for both regulators and the
regulated industry. The NRC’s
implementation of these principles has
served the public, the Agreement States,
and the regulated community well. The
Commission further suggests that such
principles may be useful as a part of a
common culture that the NRC and the
Agreement States share as co-regulators.
Accordingly, the Commission
encourages each Agreement State to
adopt a similar set of principles for use
in its own regulatory program.
For a regulator to achieve
independence nothing but the highest
possible standards of ethical
performance and professionalism
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should influence regulation. However,
independence does not imply isolation.
All available facts and opinions must be
sought openly from licensees and other
interested members of the public. The
many and possibly conflicting public
interests involved must be considered.
Final decisions must be based on
objective, unbiased assessments of all
information and must be documented
with reasons explicitly stated.
Nuclear regulation is the public’s
business and it must be transacted
publicly and candidly. The public must
be informed about and have the
opportunity to participate in the
regulatory processes as required by law.
Open channels of communication must
be maintained with Congress, other
government agencies, licensees, and the
public, as well as with the international
nuclear community.
The American taxpayer, the ratepaying consumer, and licensees are all
entitled to the best possible
management and administration of
regulatory activities. The highest
technical and managerial competence is
required and must be a constant agency
goal. The NRC must establish means to
evaluate and continually upgrade its
regulatory capabilities. Regulatory
activities should be consistent with the
degree of risk reduction they achieve.
Where effective alternatives are
available, the option which minimizes
the use of resources should be adopted.
Regulatory decisions should be made
without undue delay.
Regulations should be coherent,
logical, and practical. There should be
a clear nexus between regulations and
agency goals and objectives whether
explicitly or implicitly stated. Agency
positions should be readily understood
and easily applied.
Regulations should be based on the
best available knowledge from research
and operational experience. Systems
interactions, technological
uncertainties, and the diversity of
licensees and regulatory activities must
all be taken into account so that risks
are maintained at an acceptably low
level. Once established, regulation
should be perceived to be reliable and
not unjustifiably in a state of transition.
Regulatory actions should always be
fully consistent with written regulations
and should be promptly, fairly, and
decisively administered so as to lend
stability to the nuclear operational and
planning processes. Failure to adhere to
these principles of good regulation in
the conduct of operations should be a
sufficient reason for a regulatory
program to self-initiate program changes
that will result in needed
improvements. All involved should
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welcome expressions of concern that
indicate a program may not be operating
in accordance with these principles and
revise their program to more completely
reflect these principles.
It is not intended that these principles
of good regulation be established as
formal criteria against which the NRC
and Agreement State programs would be
assessed. Rather, these principles
should be incorporated into the day-today operational fabric of the NRC and
Agreement State materials programs.
These principles should be used in the
formulation of policies and programs,
implementation of those policies and
programs, and assessments of program
effectiveness. Application of these
principles will ensure that complacency
will be minimized, that adequate levels
of protection of public health and safety
are being provided, and that
Government employees tasked with the
responsibility for these Federal and
State regulatory programs serve the
public in an effective, efficient, and
responsive manner. These principles are
primarily for the use of the NRC and
Agreement State materials program
managers and staff in the selfassessment of their respective programs
and to use in the establishment of goals
and objectives for the continual
improvement of their respective
programs. Deficiencies identified during
the conduct of the NRC Region and
Agreement State formal program
performance reviews may indicate that
the program is not adhering to these
principles of good regulation. The
organization being assessed should
factor the need for these principles into
its actions to address identified
deficiencies.
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2. Coherent Nationwide Effort
The mission of the NRC is to assure
that civilian use of nuclear materials in
the United States is carried out with
adequate protection of public health and
safety. NRC acknowledges its
responsibility, shared with the
Agreement States, to ensure that the
regulatory programs of the NRC and the
Agreement States collectively establish
a coherent nationwide effort for the
control of agreement material. The basic
elements of such regulatory programs
include the ability to ensure adequate
protection of public health and safety,
compatibility in areas of national
interest, sufficient flexibility to
accommodate local needs and
conditions, the ability to assess program
performance on a consistent and
nationwide basis, and principles of good
regulation in program administration.
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3. Adequate To Protect Public Health
and Safety
The NRC and the Agreement States
have the responsibility to ensure
adequate protection of public health and
safety in the administration of their
respective regulatory programs
controlling the safe and secure use of
agreement materials. Accordingly, the
NRC and Agreement State programs
shall possess the requisite supporting
legislative authority, implementing
organization structure and procedures,
and financial and human resources to
effectively administer a radiation
control program that ensures adequate
protection of public health and safety.
4. Compatible in Areas of National
Interest
The NRC and the Agreement States
have the responsibility to ensure that
consistent and compatible radiation
control programs are administered.
Such radiation control programs should
be based on a common regulatory
philosophy including the common use
of definitions and standards. They
should not only be effective and
cooperatively implemented by the NRC
and the Agreement States, but also
should provide uniformity and
consistency in program areas having
national significance.
Such areas include those affecting
interstate commerce, movement of
goods and provision of services, security
of Category 1 and 2 radioactive sources,
and safety reviews for the manufacture
and distribution of sealed sources and
devices. Also necessary is the ability to
communicate using a nationally
accepted set of terms with common
understanding, the ability to ensure an
adequate level of protection of public
health and safety that is consistent and
stable across the nation, and the ability
of the NRC and each Agreement State to
evaluate the effectiveness of the NRC
and Agreement State programs for the
regulation of agreement material with
respect to protection of public health
and safety.
5. Flexibility
With the exception of those
compatibility areas where all programs
should be essentially identical, to the
extent possible, Agreement State
radiation control programs for
agreement materials should be provided
with flexibility in program
implementation to accommodate
individual State preferences, State
legislative direction, and local needs
and conditions. However, the exercise
of such flexibility should not preclude,
or effectively preclude, a practice
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authorized by the AEA, and in the
national interest. That is, a State would
have the flexibility to design its own
program, including incorporating more
stringent, or similar, requirements
provided that the requirements for
adequacy are still met and compatibility
is maintained, and the more stringent
requirements do not preclude or
effectively preclude a practice in the
national interest without an adequate
public health and safety or
environmental basis related to radiation
protection.
C. New Agreements
Section 274 of the AEA requires that
once a decision to request Agreement
State status is made by the State, the
Governor of that State must certify to
the NRC that the State desires to assume
regulatory responsibility and has a
program for the control of radiation
hazards adequate to protect public
health and safety with respect to the
materials within the State covered by
the proposed agreement. This
certification will be provided in a letter
to the NRC that includes a number of
documents in support of the
certification. These documents include
the State’s enabling legislation, the
radiation control regulations, a narrative
description of the State program’s
policies, practices, and procedures, and
a proposed agreement.
The NRC has published criteria
describing the necessary content these
documents are required to cover. The
NRC reviews the request and publishes
notice of the proposed agreement in the
Federal Register to provide an
opportunity for public comment. After
consideration of public comments, if the
Commission determines that the State
program is adequate and compatible,
and approves the agreement, a formal
agreement document is signed by the
Governor and the Chairman of the NRC.
D. Program Assistance
The NRC will offer training and other
assistance to States, such as assistance
in developing regulations and program
descriptions to help individual States
prepare for entrance into agreements
and to help them prior to the
assumption of regulatory authority.
Following assumption of regulatory
authority by a new Agreement State, to
the extent permitted by resources, the
NRC may provide training opportunities
and other assistance such as review of
proposed regulatory changes to help
States administer their regulatory
responsibilities. The NRC may also use
its best efforts to provide specialized
technical assistance to Agreement States
to address unique or complex licensing,
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inspection, and limited enforcement
issues. In areas where Agreement States
have particular expertise or are in the
best position to provide immediate
assistance to the NRC or other
Agreement States, they are encouraged
to do so. In addition, the NRC and
Agreement States will keep each other
informed about relevant aspects of their
programs. The NRC will provide an
opportunity for Agreement States to
have early and substantive involvement
in rulemaking, policy, and guidance
development activities. Agreement
States should provide a similar
opportunity to the NRC to make it aware
of, and to provide the opportunity to
review and comment on, proposed
changes in regulations and significant
changes to Agreement State programs,
policies, and regulatory guidance.
If an Agreement State experiences
difficulty in program administration, the
Commission would use its best efforts to
assist the State in maintaining the
effectiveness of its radiation control
program. Such assistance could address
an immediate difficulty or a chronic
difficulty affecting the State’s ability to
discharge its responsibility to continue
to ensure adequate protection of public
health and safety. Under certain
conditions Agreement States can also
voluntarily return part or all of its
Agreement State program, e.g., Sealed
Source and Device evaluations and
uranium recovery regulatory oversight
(SECY–95–0136).
programs are adequate to protect public
health and safety and that Agreement
State programs are compatible with the
NRC’s program. The IMPEP process
employs a Management Review Board
(MRB), composed of senior NRC
managers and an Agreement State
Liaison to make a determination of
program adequacy and compatibility.
As a part of the performance
evaluation process, the NRC will take
any necessary actions to help ensure
that Agreement State radiation control
programs remain adequate and
compatible. These actions may include
more frequent IMPEP reviews of
Agreement State programs and
provision of assistance to help address
weaknesses or areas needing
improvement within an Agreement
State program. Enhanced oversight,
suspension, or termination of an
agreement may be considered for
serious program deficiencies or
emergencies. The NRC’s actions will be
based on a well-defined and predictable
process and a performance evaluation
program that will be consistently and
fairly applied.
E. Performance Evaluation
Under Section 274 of the AEA, as
amended, the Commission retains
authority for ensuring that Agreement
State programs continue to provide
adequate protection of public health and
safety. In fulfilling this statutory
responsibility, the NRC will periodically
evaluate Agreement State radiation
control programs to determine whether
the programs are adequate and
compatible prior to entrance into a
Section 274b. agreement and ensure
they continue to be adequate and
compatible after an agreement becomes
effective.
The Commission, in cooperation with
the Agreement States, established and
implemented the Integrated Materials
Performance Evaluation Program
(IMPEP). The IMPEP is a performance
evaluation process that provides the
NRC and Agreement State management
with systematic, integrated, and reliable
evaluations of the strengths and
weaknesses of their respective radiation
control programs and identification of
areas needing improvement.
Performance indicators are used to
evaluate and ensure that regulatory
Finding 1—Adequate To Protect Public
Health and Safety
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F. Levels of Agreement State Program
Review Findings
The following discussion outlines the
nature of the NRC findings regarding the
NRC’s Agreement State review process.
1. Adequacy
If the NRC finds that an Agreement
State program has met all of the IMPEP
review criteria or that only minor
deficiencies exist, the NRC would find
that the Agreement State’s program is
adequate to protect public health and
safety.
Finding 2—Adequate To Protect Public
Health and Safety With Improvement
Needed
If the NRC finds that an Agreement
State program protects public health
and safety, but is deficient in meeting
some of the IMPEP review criteria, the
NRC may find that the Agreement
State’s program is adequate with
improvement needed. The NRC would
consider in its determination plans that
the State has to address any of the
deficiencies noted during the review. In
cases where less significant Agreement
State deficiencies previously identified
have been uncorrected for a significant
period of time, the NRC may also find
that the program is adequate with
improvement needed.
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Finding 3—Not Adequate To Protect
Public Health and Safety
If the NRC finds that an Agreement
State program is significantly deficient
in some or all of the review criteria, the
NRC would find that the Agreement
State’s program is not adequate to
protect public health and safety.
2. Compatibility
Finding 1—Compatible
If the NRC determines that an
Agreement State program contains all
required NRC program elements for
compatibility, or only minor
discrepancies exist, the program would
be found compatible.
Finding 2—Not Compatible
If the NRC determines that an
Agreement State has a program that
disrupts the orderly pattern of
regulation among the collective
regulatory efforts of the NRC and other
Agreement States (i.e., creates conflicts,
gaps, or duplication in regulation), the
program would be found not
compatible.
G. NRC Actions as a Result of These
Findings
The following discussion outlines the
options available to the NRC as a result
of making any of the above findings.
The appropriate action will be
determined on a case-by-case basis by
the MRB. Subsequent to an Agreement
State program review, the findings
would be recounted in a letter to senior
level State management.
If the NRC finds that a State program
is adequate and compatible, no further
action would be required, except a
response by the State to any
recommendations.
If serious performance issues are
noted during the program review, NRC
may increase the frequency of contacts
with the State to keep abreast of
developments and conduct onsite
follow-up reviews to assure that
progress is being made on correcting
those issues. Circumstances that can
lead to more frequent contact between
the NRC and the Agreement State
program include the following:
identification of serious program
deficiencies, previously identified
deficiencies that have gone uncorrected
for a significant period of time, and/or
deficiencies in adopting required
compatibility program elements.
If findings of subsequent reviews
show that the State has taken
appropriate corrective actions and that
these actions have shown a sustained
improvement in performance, the MRB
will determine whether the status of an
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Agreement State program may be moved
to another level of oversight. If the MRB
finds that all deficiencies have been
corrected, it may determine that the
Agreement State program is adequate
and/or compatible.
Options to address serious
performance issues include one or more
of the following actions: monitoring,
heightened oversight, probation,
suspension, and termination.
1. Monitoring
Monitoring is an informal process that
allows the NRC to maintain an
increased level of communication with
an Agreement State Program through
periodic (usually bimonthly) calls
between the NRC and State managers/
staff. Monitoring is implemented in
cases where weaknesses in a program
have resulted in, or are likely to result
in, less than satisfactory performance for
one or more performance indicators.
Monitoring may be considered based on
results of a routine IMPEP review, a
follow-up IMPEP review, a periodic
meeting or other interaction with the
Agreement State program. In cases
where one or more performance
indicators remain less than satisfactory
or further degraded, the MRB will
consider placing a State on Heightened
Oversight.
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2. Heightened Oversight
Heightened Oversight is a formalized
process that allows the NRC to maintain
an increased level of communication
with an Agreement State usually
through monthly calls between the NRC
and State managers/staff. Heightened
Oversight is implemented in cases
where significant program weaknesses
are identified, but are not determined to
be serious enough to find the program
inadequate to protect public health and
safety. In addition to the monthly calls,
a State placed on Heightened Oversight
is required to submit a Program
Improvement Plan describing actions to
be taken by the State to address the
program deficiencies, including specific
goals and milestones. The Program
Improvement Plan allows the NRC to
monitor the actions being taken and the
implementation schedule for those
actions that address the weaknesses
identified based on the results of an
IMPEP review, a periodic meeting, or
other interaction with the Agreement
State program. If programmatic
weaknesses are serious enough to find
the program inadequate to protect
public health and safety, or if
weaknesses continue throughout the
period of heightened oversight, the MRB
may elect to make a recommendation to
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the Commission to place the Agreement
State on probation.
3. Probation
Probation is a formalized process,
requiring Commission approval and
notification to the Agreement State’s
governor, which allows the NRC to
maintain an increased level of
communication with an Agreement
State program. Probation is considered
in cases where the State’s program is
found to be not adequate to protect
public health and safety, or not
compatible with the NRC’s program. An
Agreement State may also be placed on
probation when it has not addressed
previously identified program
weaknesses. The process allows the
NRC to monitor the actions being taken
by the State to correct the identified
weaknesses and the implementation
schedule for those actions.
Probation would include all the
requirements for Heightened Oversight
previously described. In addition, the
NRC would communicate its findings to
a higher level of State management.
Written notification of probationary
status would be sent to the Governor of
the State, a notice published in the
Federal Register, and a press release
issued. Notice would also be given to
the State’s Congressional delegation, the
appropriate Congressional committee(s),
and all Agreement and non-Agreement
States.
If requested, the NRC may provide
technical support for the maintenance of
the regulatory program. The
probationary period would normally be
one year or less. At the end of that time,
if the State has not addressed the
deficiencies, the NRC may extend the
probationary period or institute
suspension or termination proceedings.
4. Suspension
Section 274j. of the AEA gives the
Commission authority to suspend all or
part of its agreement with a State if the
suspension is required to protect public
health and safety, or if the State has not
complied with one or more of the
requirements of Section 274 of the AEA.
In cases where program deficiencies are
such that the Commission must take
action to protect public health and
safety, or if the program has not
complied with one or more of the
requirements of Section 274 of the AEA,
the Commission may suspend all or part
of its agreement with the State. In cases
where a State has failed to respond in
an acceptable manner during the
probationary period, suspension may be
considered.
Before reaching a final decision on
suspension, the Commission will notify
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the State and provide the State an
opportunity for a hearing on the
proposed suspension. Notice of the
proposed suspension will also be
published in the Federal Register.
Suspension, rather than termination,
would be the preferred option in those
cases where the State provides evidence
that the program deficiencies are
temporary and that the State is
committed to correcting the deficiencies
that led to the suspension.
In addition to the normal suspension
authority, Section 274j(2) of the AEA
also addresses emergency situations and
gives the Commission authority to
temporarily suspend all or part of its
agreement with a State without notice or
hearing if an emergency situation exists
requiring immediate action to protect
public health and safety, and the State
has failed or is unable to take necessary
action within a reasonable time.
In cases where the Commission
decides to suspend the agreement, the
NRC would communicate its findings to
a higher level of State management. The
NRC would issue an order temporarily
suspending all or part of the 274b.
agreement and an order to State
licensees notifying them of the
temporary suspension of all or part of
the 274b. agreement. Written
notification of suspension would be sent
to the Governor of the State, a notice
published in the Federal Register, and
a press release issued. Notice would
also be given to the State’s
Congressional delegation, the
appropriate Congressional committee(s),
and all Agreement and non-Agreement
States.
5. Termination
Section 274j. of the AEA gives the
Commission authority to terminate all
or part of its agreement with a State if
such termination is required to protect
public health and safety, if the State
program has not complied with one or
more of the requirements of Section 274
of the AEA (e.g., is found to be not
compatible with the Commission’s
program for regulation of agreement
materials), or by State request. When the
Commission finds such significant
program deficiencies, the Commission
would institute formal proceedings to
terminate its agreement with the State.
In cases where the State has requested
termination of the agreement, notice and
opportunity for a hearing are not
necessary.
In cases where a State has failed to
respond in an acceptable manner during
the probationary period and there is no
prospect for improvement, termination
will be considered. Before reaching a
final decision on termination, the
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Commission will notify the State and
provide the State an opportunity for a
hearing on the proposed termination.
Also, notice of the proposed
termination will be published in the
Federal Register. There may be cases
where termination will be considered
even though the State program has not
been placed on probation.
H. Program Funding
Section 274 of the AEA does not
allow Federal funding for the
administration of Agreement State
radiation control programs. Section 274
of the AEA permits the NRC to offer
training and other assistance to a State
in anticipation of entering into an
Agreement with the NRC. However, it is
the NRC policy not to fund the
establishment of new Agreement State
programs. Regarding training, given the
importance in terms of public health
and safety of having well trained
radiation control program personnel, the
NRC may offer certain relevant training
courses and notify Agreement State
personnel of their availability.
J. Program Evolution
The NRC-Agreement State program is
dynamic and the NRC and Agreement
States will continue to jointly assess the
NRC and Agreement State programs for
the regulation of agreement materials to
identify specific changes that should be
considered based on experience or to
further improve overall performance
and effectiveness. The changes
considered may include possible
legislative changes. The program should
also include the formal sharing of
information and views such as briefings
of the Commission by the Agreement
States.
VI. Topics for Additional Comment
The NRC is requesting additional
comments on key topics in response to
direction received from the Commission
on the development of both Policy
Statements (SRM–SECY–12–0112,
‘‘Policy Statements in Agreement State
Programs’’). Specifically, the NRC is
seeking comments on the following
topics:
sroberts on DSK5SPTVN1PROD with NOTICES
I. Regulatory Development
The NRC and Agreement States will
cooperate in the development of both
new and revised regulations and
policies. Agreement States will have
early and substantive involvement in
the development of regulations affecting
protection of public health and safety
and of policies affecting administration
of the Agreement State program. The
NRC and Agreement States will keep
each other informed about their
individual regulatory requirements (e.g.,
regulations or license conditions) and
the effectiveness of those regulatory
requirements so that each has the
opportunity to make use of proven
regulatory approaches to further the
effective and efficient use of resources.
The Conference of Radiation Control
Program Directors, Inc. (CRCPD) assists
its members in their efforts to protect
the public, radiation workers, and
patients from unnecessary radiation
exposure. CRCPD’s mission, in part, is
‘‘to promote consistency in addressing
and resolving radiation protection
issues.’’ The CRCPD provides a forum
for centralized communication on
radiation protection matters between the
States and the Federal Government and
between individual States. One product
of this forum is the development of the
CRCPD Suggested State Regulations for
use by its members. The NRC also
reviews Suggested State Regulations for
compatibility.
1. Section IV. Policy Statement on
Adequacy and Compatibility of
Agreement State Programs, Item 1.B.
Compatibility Category B
(1) To clarify the meaning of a
‘‘significant transboundary
implication,’’ the NRC is proposing to
define a significant transboundary
implication as ‘‘one which crosses
regulatory jurisdictions, has a particular
impact on public health and safety, and
needs to be addressed to ensure
uniformity of regulation on a
nationwide basis.’’ However, the NRC
recognizes that the use of the word
‘‘particular’’ can be vague and cause
confusion. The NRC is requesting
specific comments on the proposed
draft definition of ‘‘significant
transboundary implication’’ and
whether the word ‘‘particular’’ should
be replaced with the phrase ‘‘significant
and direct.’’
(2) Program elements with significant
transboundary implications are
illustrated by examples in the 1997
version of the Policy Statement.
(3) The NRC staff concluded the
examples listed are not all-inclusive and
could lead to misinterpretation by
stakeholders, Agreement States, and the
NRC staff. The NRC staff is seeking
additional comment on whether or not
the examples should be retained in this
section of the policy statement.
(4) The NRC is requesting comments
on the description of Compatibility
Category B as written in Section IV. of
this notice and whether or not the
movement of goods and services, which
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33131
historically has been a main factor in
determining whether an issue has
transboundry implications, should be
considered in the definition of
significant transboundry implication.
(5) The NRC is requesting comments
on whether or not economic factors
should be a consideration when making
a Compatibility Category B
determination. The NRC believes that
health and safety should be the primary
consideration in making a Compatibility
B determination and that economic
factors should not be a consideration.
(6) The NRC is requesting comments
on alternative versions of wording
regarding what types of program
elements will be assigned a
Compatibility Category B designation as
well as how limited in number these
will be. The original Policy Statement
published in 1997 stated, in part: ‘‘The
Commission will limit this category to
a small number of program elements
(e.g., transportation regulations and
sealed source and device registration
certificates) that have significant
transboundary implications.’’ The
Working Group proposed keeping the
language in the 1997 version of the
Policy Statement; however, some
believed that this statement could be
interpreted to imply that the
Commission is limited in its ability to
assign rules in this compatibility
category. Therefore, alternative language
was proposed as follows: ‘‘The
Commission will limit this category to
program elements that have significant
transboundary implications. The
Commission expects that these will be
limited in number.’’ Some members of
the working group disagreed with this
alternative language and believed that
the original language should be
retained. The details of this discussion
are in Enclosure 3 of SECY–12–0112,
‘‘Policy Statements on Agreement State
Programs.’’ In summary, some members
of the Working Group believed that the
original language in the 1997 version of
the Policy Statement was not intended
to dictate the Commission’s authority
but rather was to remind those staff
proposing designations of compatibility
B to the Commission for consideration
that program elements of this
designation should be few as opposed to
many and should involve only
significant transboundary implications.
Additionally, by removing the
distinction that there should be a small
number of program elements, it
deemphasizes the idea that Agreement
States should be given flexibility when
addressing the majority of program
elements necessary for a compatible
program.
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2. Section IV. Policy Statement on
Adequacy and Compatibility of
Agreement State Programs, Item.
Summary and Conclusions
The NRC is requesting comments on
alternative versions of wording
regarding the expectation on the number
of regulatory requirements that
Agreement States will be requested to
adopt in an identical manner to
maintain compatibility. This language
would cover all regulatory requirements
as compatibility category A, B, and C.
(Agreement States are required to adopt
regulatory requirements listed as Health
and Safety to ensure their program is
adequate to protect public health and
safety, but not for compatibility
purposes). In the third paragraph under
‘‘Summary and Conclusions’’ of the
original Policy Statement published in
1997, it stated, in part: ‘‘The
Commission will minimize the number
of NRC regulatory requirements that the
Agreement States will be requested to
adopt in an identical manner to
maintain compatibility.’’ The Working
Group proposed keeping this sentence
as written; however, some members of
the Working Group believed that that
this sentence could be interpreted to
imply that there is a requirement that
the Commission minimize such requests
to Agreement States, rather than a
statement that reflects the expectation
that situations justifying such requests
will not arise frequently. The sentence
was revised as follows: ‘‘The
Commission will identify regulatory
requirements that the Agreement States
will be requested to adopt in an
identical manner to maintain
compatibility. The expectation is that
these requirements will be limited.’’
Some members of the Working Group
disagreed with this revision and
believed that the original language
should be retained. The details of this
discussion are in Enclosure 3 of SECY–
12–0112, ‘‘Policy Statements on
Agreement State Programs.’’ In
summary, some members of the
Working Group believed that the
original text places emphasis on the
effort to minimize unnecessary burden
on the Agreement States’ means to
accomplish the same goals as the NRC.
Additionally, the suggested changes do
not encourage careful consideration as
to whether there are other possible
options to meet the same intended goal.
3. Performance Based Approach for
Determining Compatibility
Currently, Agreement States are
afforded some flexibility to use
approaches other than rulemaking, such
as license conditions or orders, to
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implement requirements. The NRC staff
is seeking additional input on whether
a performance-based approach for
determining compatibility of an
Agreement State’s radiation control
program should be developed.
Agreement States could be afforded
additional flexibility to use other
approaches to implement requirements.
A performance-based approach would
not rely on a requirement to adopt
within 3 years from the effective date of
the NRC regulation in order to
determine compatibility of an
Agreement State program. In a separate
Commission vote paper, the NRC staff
will use input from comments received
on this topic to create a
recommendation and an
implementation plan to provide to the
Commission for approval.
4. Adequacy Determinations of
Agreement State Programs
The NRC staff is seeking additional
input on whether: (1) a revised set of
performance metrics could be used to
replace, supplement, or expand upon
IMPEP in determining adequacy of an
Agreement State’s radiation control
program; and (2) a single holistic
determination can be made that would
accurately reflect the overall adequacy
and compatibility of a program. Given
the current environment of limited
resources, it is imperative that the NRC
be able to develop a clear set of
performance based metrics that consider
the limitations of an Agreement State
program and provide increased
flexibility without compromising public
health and safety. In a separate
Commission vote paper, the NRC staff
will use input from comments received
on this topic to create a
recommendation or series of
recommendations for Commission
approval.
VI. Paperwork Reduction Act
This Policy Statement does not
contain information collection
requirements that are subject to the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
Public Protection Notification
The NRC may not conduct or sponsor,
and a person is not required to respond
to, a request for information or an
information collection requirement
unless the requesting documents
displays a currently valid Office of
Management and Budget control
number.
Dated at Rockville, Maryland, this 28th day
of May, 2013.
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For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary for the Commission.
[FR Doc. 2013–13066 Filed 5–31–13; 8:45 am]
BILLING CODE 7590–01–P
NUCLEAR REGULATORY
COMMISSION
[NRC–2012–0072]
Quality Verification for Plate-Type
Uranium-Aluminum Fuel Elements for
Use in Research and Test Reactors
Nuclear Regulatory
Commission.
ACTION: Regulatory guide; issuance.
AGENCY:
The U.S. Nuclear Regulatory
Commission (NRC) is issuing a revision
to Regulatory Guide (RG) 2.3, ‘‘Quality
Verification for Plate-Type UraniumAluminum Fuel Elements for Use in
Research and Test Reactors.’’ This guide
describes a method that the staff of the
NRC considers acceptable for complying
with the Commission’s regulations
concerning establishing and executing a
quality assurance program for verifying
the quality of plate-type uraniumaluminum fuel elements used in
research and test reactors (RTRs).
ADDRESSES: Please refer to Docket ID
NRC–2012–0072 when contacting the
NRC about the availability of
information regarding this document.
You may access information related to
this document, which the NRC
possesses and is publicly available,
using any of the following methods:
• Federal Rulemaking Web site: Go to
https://www.regulations.gov and search
for Docket ID NRC–2012–0072. Address
questions about NRC dockets to Carol
Gallagher; telephone: 301–492–3668;
email: Carol.Gallagher@nrc.gov. For
technical questions, contact the
individual(s) listed in the FOR FURTHER
INFORMATION CONTACT section of this
document.
• NRC’s Agencywide Documents
Access and Management System
(ADAMS): You may access publicly
available documents online in the NRC
Library at https://www.nrc.gov/readingrm/adams.html. To begin the search,
select ‘‘ADAMS Public Documents’’ and
then select ‘‘Begin Web-based ADAMS
Search.’’ For problems with ADAMS,
please contact the NRC’s Public
Document Room (PDR) reference staff at
1–800–397–4209, 301–415–4737, or by
email to pdr.resource@nrc.gov. The
ADAMS accession number for each
document referenced in this notice (if
that document is available in ADAMS)
is provided the first time that a
SUMMARY:
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Agencies
[Federal Register Volume 78, Number 106 (Monday, June 3, 2013)]
[Notices]
[Pages 33122-33132]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13066]
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
[NRC-2013-0081]
Policy Statement on Adequacy and Compatibility of Agreement State
Programs; Statement of Principles and Policy for the Agreement State
Program
AGENCY: Nuclear Regulatory Commission.
ACTION: Policy statements; draft revisions and request for comment.
-----------------------------------------------------------------------
SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is proposing
revisions to its policy statements on Agreement State Programs. Both
the ``Policy Statement on Adequacy and Compatibility of Agreement State
Programs'' and the ``Statement of Principles and Policy for the
Agreement State Program'' have been revised to add information on
security of radioactive materials and incorporate changes in the NRC's
policies and procedures since the last revision in 1997. In addition to
requesting comments on the revisions made to the policy statements, the
NRC is specifically requesting comments on (1) Compatibility Category B
in the ``Policy Statement on Adequacy and Compatibility of Agreement
State Programs,'' (2) consideration of a performance based approach in
determining Agreement State compatibility, and (3) performance based
metrics in the adequacy determination of an Agreement State program.
DATES: Submit comments by August 19, 2013. 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.
ADDRESSES: You may submit comment by any of the following methods
(unless this document describes a different method for submitting
comments on a specific subject):
Federal Rulemaking Web site: Go to https://www.regulations.gov and search for Docket ID NRC-2013-0081. Address
questions about NRC dockets to Carol Gallagher; telephone: 301-492-
3668; email: Carol.Gallagher@nrc.gov. For technical questions, contact
the individual(s) listed in the FOR FURTHER INFORMATION CONTACT section
of this document.
Email comments to: Rulemaking.Comments@nrc.gov. If you do
not receive an automatic email reply confirming receipt, then contact
us at 301-415-1677.
Fax comments to: Secretary, U.S. Nuclear Regulatory
Commission at 301-415-1101.
Mail comments to: Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, ATTN: Rulemakings and
Adjudications Staff.
Hand deliver comments to: 11555 Rockville Pike, Rockville,
Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal
workdays; telephone: 301-415-1677.
For additional direction on accessing information and submitting
comments, see ``Accessing Information and Submitting Comments'' in the
SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: Lisa Dimmick, Office of Federal and
State Materials and Environmental Management Programs, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-
0694, email: Lisa.Dimmick@nrc.gov.
SUPPLEMENTARY INFORMATION:
I. Accessing Information and Submitting Comments
II. Background
III. Discussion
IV. Proposed Revision to Policy Statement on Adequacy and
Compatibility of Agreement State Programs
V. Proposed Revision to Statement of Principles and Policy for the
Agreement State Program
VI. Topics for Additional Comment
VII. Paperwork Reduction Act
I. Accessing Information and Submitting Comments
A. Accessing Information
Please refer to Docket ID NRC-2013-0081 when contacting the NRC
about the availability of information for the proposed revisions of the
policy statements. You may access information related to the proposed
revisions of the policy statements, which the NRC possesses and is
publicly available, by any of the following methods:
Federal Rulemaking Web site: Go to https://www.regulations.gov and search for Docket ID NRC-2013-0081.
NRC's Agencywide Documents Access and Management System
[[Page 33123]]
(ADAMS): You may access public documents online in the NRC Library at
https://www.nrc.gov/reading-rm/adams.html. To begin the search, select
``ADAMS Public Documents'' and then select ``Begin Web-based ADAMS
Search.'' For problems with ADAMS, please contact the NRC's Public
Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or
by email to pdr.resource@nrc.gov. The ADAMS accession number for each
document referenced in this notice (if that document is available in
ADAMS) is provided the first time that a document is referenced.
NRC's PDR: You may examine and purchase copies of public
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland 20852.
B. Submitting Comments
Please include Docket ID NRC-2013-0081 in the subject line of your
comment submission, in order to ensure that the NRC is able to make
your comment submission available to the public in this docket.
The NRC cautions you not to include identifying or contact
information that you do not want to be publicly disclosed in your
comment submission. The NRC will post all comment submissions at https://www.regulations.gov as well as enter the comment submissions into
ADAMS. The NRC does not routinely edit comment submissions to remove
identifying or contact information.
If you are requesting or aggregating comments from other persons
for submission to the NRC, then you should inform those persons not to
include identifying or contact information that they do not want to be
publicly disclosed in their comment submission. Your request should
state that the NRC does not routinely edit comment submissions to
remove such information before making the comment submissions available
to the public or entering the comment submissions into ADAMS.
II. Background
On August 25, 1993, the Commission requested the NRC staff to
recommend improvements to the NRC's Agreement State Program to assure
adequate protection of public health and safety. Among these
improvements, the NRC staff, with participation from Agreement State
representatives, developed two policy statements. The policy statements
are entitled ``Policy Statement on Adequacy and Compatibility of
Agreement State Programs'' and ``Statement of Principles and Policy for
the Agreement State Program.'' The Commission approved both policy
statements on June 29, 1995, but deferred their implementation until
all implementing procedures were completed and approved by the
Commission. These policy statements became effective on September 3,
1997 (62 FR 46517).
In Staff Requirements Memorandum (SRM), ``SECY-10-0105, Final Rule:
Limiting the Quantity of Byproduct Material in a Generally Licensed
Device'' (ADAMS Accession No. ML103360262) dated December 2, 2010, the
Commission directed the NRC staff to update the Commission's ``Policy
Statement on Adequacy and Compatibility of Agreement State Programs''
and associated guidance documents to include both safety and source
security considerations in the determination process. Because Agreement
State adequacy and compatibility are key components of the Integrated
Materials Performance Evaluation Program (IMPEP) process,\1\ the
Commission's Policy Statement on the ``Statement of Principles and
Policy for the Agreement State Program'' is being revised concurrently.
Two Working Groups operating in accordance with NRC Management
Directive 5.3, ``Agreement State Participation in Working Groups,''
dated August 22, 2007 (ADAM Accession No. ML070940610), are drafting
the revisions to these policy statements. The two Working Groups met
concurrently and periodically interfaced in developing the proposed
revisions. The revisions include adding information on security of
radioactive materials and updating the policy statements to reflect
subsequent changes in the NRC policies and procedures.
---------------------------------------------------------------------------
\1\ The NRC developed the IMPEP process to evaluate the adequacy
and compatibility of Agreement State Programs and the adequacy of
the NRC's nuclear materials program activities.
---------------------------------------------------------------------------
III. Discussion
The Commission tasked the staff with updating the Commission's
Policy Statement, ``Policy Statement on Adequacy and Compatibility of
Agreement State Programs,'' and associated guidance, to include both
safety and source security in the determination process. The Policy
Statement as issued in 1997 continues to remain relevant and
effectively serves the mission of the agency. However, the staff
concluded that the ``Policy Statement on Adequacy and Compatibility of
Agreement State Programs'' and the ``Statement of Principles and Policy
for the Agreement State Program'' both required revision to meet the
intent of the SRM by clarifying that security is part of the agency's
health and safety mission and update the policy statements to include
current policies, procedures, and practices.
Following the events of September 11, 2001, the NRC's regulatory
oversight was enhanced. Additional security measures were developed and
implemented. While safety and source security have always been inherent
to the protection of public health and safety, the Working Groups
recognized that the two policy statements needed to specifically
acknowledge that the NRC and Agreement State oversight of these
enhanced security measures should not be confused with the NRC's
mission to promote the common defense and security. The Working Groups
revised the purpose sections of the policy statements to indicate that
public health and safety includes physical protection of ``agreement
material.''
The two Working Groups also reconciled a difference in terminology
in the policy statements as they were originally published. The
``Policy Statement on Adequacy and Compatibility of Agreement State
Programs'' used the term ``agreement material'' to refer to byproduct,
source, and small quantities of special nuclear material as defined in
Section 274b. of the Atomic Energy Act (AEA) of 1954, as amended. The
``Statement of Principles and Policy for the Agreement State Program''
used the term ``AEA material'' to describe the same material. While the
terms ``agreement material'' and ``AEA material'' are generally viewed
as synonymous, using different terms in the policies may be construed
as an indication that the NRC intended the terms to have different
meanings. The Working Groups decided to use the term ``agreement
material'' throughout both policy statements.
Policy Statement on Adequacy and Compatibility of Agreement State
Programs
As explained in greater detail in Section VI, ``Topics for
Additional Comment,'' of this document, the NRC is requesting comments
on the language used to describe and define Compatibility Category B.
The language from the 1997 version of the Policy Statement was left in
place in the draft revision so that the input requested could be based
on the description currently used when making a determination of
Compatibility Category B. For Compatibility Category C, the Working
Group felt it was important to clarify that program elements and
regulations assigned this category of
[[Page 33124]]
compatibility could be more restrictive than the equivalent NRC program
element or regulation. Additionally, the NRC is requesting comments on
what types of program elements should be designated as a Compatibility
Category B. The NRC is also requesting comment as to whether the number
of Compatibility Category B program element should be limited.
The NRC expects to hold two public meetings during the public
comment period. The agendas for the two public meetings, including the
dates and locations, will be posted on the NRC's public meeting
schedule Web site at https://www.nrc.gov/public-involve/public-meetings/index.cfm.
Statement of Principles and Policy for the Agreement State Program
Several changes were made throughout the Policy Statement to
demonstrate a clear connection between public health, safety, and
security. The NRC and Agreement State radiation control programs
maintain regulatory oversight for the safe and secure handling of
nuclear materials. These programs have always included the security of
nuclear materials as an integral part of their health and safety
mission as it relates to minimizing the risk of exposure to workers and
the public. Throughout the 1997 Policy Statement, the phrase ``safe
use'' of material was used. To impart the concept that security is a
necessary component of public health and safety, the phrase ``safe
use'' of material was replaced with ``safe and secure use'' of
material.
Several updates were made to align the Policy Statement with
current practices under IMPEP. The Working Group expanded the text
addressing the actions taken by the NRC as a result of program review
findings to include options to address performance such as monitoring,
heightened oversight, probation, suspension, and termination.
IV. Proposed Revision to Policy Statement on Adequacy and Compatibility
of Agreement State Programs
Purpose
Section 274 of the AEA of 1954, as amended, provides for a Federal-
State regulatory framework for the control of byproduct, source, and
small quantities of special nuclear material (hereinafter termed
``agreement material'') as identified by Section 274b. of the AEA. The
NRC, by agreement with a State under Section 274 of the AEA,
relinquishes its regulatory authority in certain areas and allows the
State Government to assume that regulatory authority, as long as the
State program is adequate to protect public health and safety and
compatible with the Commission's \2\ program. For the purpose of this
Policy Statement, ``public health and safety'' includes physical
protection of agreement material.
---------------------------------------------------------------------------
\2\ For the purposes of this Policy Statement the definition of
Commission is equivalent to Title 10 of the Code of Federal
Regulations: Commission means the five members of the NRC or a
quorum thereof sitting as a body, as provided by Section 201 of the
Energy Reorganization Act of 1974, as amended.
---------------------------------------------------------------------------
Section 274 further directs the Commission to periodically review
State programs to ensure compliance with the provisions of Section 274.
This Policy Statement presents the NRC's policy for determining the
adequacy and compatibility of Agreement State programs established in
accordance with Section 274. This Policy Statement clarifies the
meaning and use of the terms ``adequate to protect public health and
safety'' and ``compatible with the Commission's regulatory program'' as
applied to the Agreement State program. The Policy Statement also
describes the general framework that will be used to identify those
program elements that Agreement State programs should implement to
adequately protect public health and safety and to be compatible with
the Commission's regulatory program. For the purposes of this Policy
Statement, ``program element'' means any component or function of a
radiation control regulatory program, including regulations and/or
other legally binding requirements imposed on regulated persons, which
contributes to implementation of that program. Finally, the Policy
Statement reflects principles discussed in the Commission's ``Statement
of Principles and Policy for the Agreement State Program,'' which
should be considered in conjunction with this Policy Statement.
This Policy Statement is solely guidance for the Commission and the
Agreement States in the implementation of the Agreement State program.
This Policy Statement does not itself impose legally binding
requirements on the Agreement States. In addition, nothing in this
Policy Statement expands the legal authority of Agreement States beyond
that already granted to them by Section 274 of the AEA and other
relevant legal authority. Nor does this Policy Statement diminish or
constrain the NRC's authority under the AEA. Implementation procedures
adopted under this Policy Statement shall be consistent with the legal
authorities of the Commission and the Agreement States.
Background
The terms ``adequate'' and ``compatible'' represent fundamental
concepts in the Agreement State program authorized in 1959 by Section
274 of the AEA. Subsection 274d. states that the Commission shall enter
into an Agreement under subsection 274b., relinquishing the NRC's
regulatory authority over certain materials in a State, provided that
the State's program is adequate to protect public health and safety and
is compatible, in all other respects, with the Commission's regulatory
program. Subsection 274g. authorizes and directs the Commission to
cooperate with States in the formulation of standards to assure that
State and Commission standards will be coordinated and compatible.
Subsection 274j(1) requires the Commission to review periodically the
Agreements and actions taken by States under the Agreements to ensure
compliance with the provisions of Section 274. Therefore, the
Commission must review the actions taken by States under the Agreements
to ensure that the programs continue to be adequate to protect public
health and safety and compatible with the Commission's program.
In identifying those program elements for adequate and compatible
programs, or any changes thereto, the NRC staff will seek the advice of
the Agreement States. The Commission will consider such advice in its
final decision.
Discussion
Section 274 of the AEA requires that Agreement State programs be
both ``adequate to protect the public health and safety'' and
``compatible with the Commission's program.'' In accordance with
Section 274 of the AEA, an Agreement State program should provide for
an acceptable level of protection of public health and safety in an
Agreement State (the ``adequacy'' component). The Agreement State
should also ensure that its program serves an overall nationwide
interest in radiation protection (the ``compatibility'' component).
Program elements for adequacy focus on the protection of public
health and safety within a particular State while program elements for
compatibility focus on the impacts of an Agreement State's regulation
of agreement material on a nationwide basis or its potential effects on
other jurisdictions. Many program elements for compatibility also
impact public health and safety; therefore, they may also be considered
program elements for adequacy.
[[Page 33125]]
1. Adequacy
An ``adequate'' program should include those program elements not
required for compatibility but necessary to maintain an acceptable
level of protection of public health and safety within an Agreement
State. These program elements make up the category Health and Safety.
An Agreement State's radiation control program is adequate to protect
public health and safety if administration of the program provides
reasonable assurance of protection of public health and safety in
regulating the use of agreement material. The level of protection
afforded by the program elements of the NRC's materials regulatory
program is presumed to be that which is adequate to provide a
reasonable assurance of protection of public health and safety.
Therefore, the overall level of protection of public health and safety
provided by a State program should be equivalent to, or greater than,
the level provided by the NRC program. To provide reasonable assurance
of protection of public health and safety, an Agreement State program
should contain the five essential program elements, identified in
Sections A. through E., that the Commission will use to define the
scope of its review of the program. The Commission will also consider,
when appropriate, other program elements of an Agreement State that
appear to affect the program's ability to provide reasonable assurance
of public health and safety protection. Such consideration will occur
only if concerns arise.
A. Legislation and Legal Authority
State statutes should:
(1) Authorize the State to establish a program for the regulation
of agreement material and provide authority for the assumption of
regulatory responsibility under an Agreement with the Commission;
(2) Authorize the State to promulgate regulatory requirements
necessary to provide reasonable assurance of protection of public
health and safety;
(3) Authorize the State to license, inspect, and enforce legally
binding requirements such as regulations and licenses; and
(4) Be otherwise consistent with applicable Federal statutes.
In addition, the State should have existing legally enforceable
measures such as generally applicable rules, license provisions, or
other appropriate measures, necessary to allow the State to ensure
adequate protection of public health and safety in the regulation of
agreement material in the State. For those items that have significant
health and safety implications, the NRC shall identify legally binding
requirements that should be adopted by Agreement States. The NRC
expects that there will be a limited number of such requirements. In
adopting such requirements, Agreement States should adopt the essential
objectives of those of the Commission.
B. Licensing
The State should conduct appropriate evaluations of proposed uses
of agreement material, before issuing a license, to assure that the
proposed licensee's operations can be conducted safely and securely.
Licenses should provide for reasonable assurance of public health and
safety protection in relation to the licensed activities.
C. Inspection and Enforcement
The State should periodically conduct inspections of licensed
activities involving agreement material to provide reasonable assurance
of safe licensee operations and to determine compliance with its
regulatory requirements. When determined to be necessary by the State,
the State should take timely enforcement action against licensees
through legal sanctions authorized by State statutes and regulations.
D. Personnel
The State should be staffed with a sufficient number of qualified
personnel to implement its regulatory program for the control of
agreement material.
E. Incidents and Allegations
The State should respond to and conduct timely inspections or
investigations of incidents, reported events, and allegations involving
agreement material within the State's jurisdiction to provide
reasonable assurance of protection of public health and safety.
1. Compatibility
A ``compatible'' program should consist of those program elements
necessary to meet a larger nationwide interest in promoting an orderly
pattern of regulation of radiation protection. Those program elements
are generally limited to areas of regulation involving radiation
protection standards and activities with significant transboundary
implications. An Agreement State radiation control program is
compatible with the Commission's regulatory program when its program
does not create conflicts, duplications, gaps, or other conditions that
would jeopardize an orderly pattern in the regulation of agreement
material on a nationwide basis. For purposes of compatibility, the
State should address the following Categories A, B, and C:
A. Category A--Basic Radiation Protection Standards
For purposes of this Policy Statement, this category includes
``basic radiation protection standards'' meaning dose limits,
concentration and release limits related to radiation protection in
Part 20 of Title 10 of the Code of Federal Regulations (10 CFR), that
are generally applicable, and the dose limits in 10 CFR 61.41.\3\ Also
included in this category are a limited number of definitions, signs,
labels, and scientific terms that are necessary for a common
understanding of radiation protection principles among licensees,
regulatory agencies, and members of the public. Such State standards
should be essentially identical to those of the Commission, unless
Federal statutes provide the State authority to adopt different
standards. Basic radiation protection standards do not include
constraints or other limits below the level associated with ``adequate
protection'' that take into account permissible balancing
considerations such as economic cost and other factors.
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\3\ The Commission will implement this category consistent with
its earlier decision in the low-level waste area to allow Agreement
States flexibility to establish pre-closure operational release
limit objectives, as low as is reasonably achievable goals or design
objectives at such levels as the State may deem necessary or
appropriate, as long as the level of protection of public health and
safety is at least equivalent to that afforded by Commission
requirements.
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B. Category B--Program Elements With Significant Transboundary
Implications
The Commission will limit this category to a small number of
program elements (e.g., transportation regulations and sealed source
and device registration certificates) that have significant
transboundary implications. Agreement State program elements should be
essentially identical to those of the Commission.
C. Category C--Other Commission Program Elements
These are other Commission program elements that are important for
an Agreement State to have in order to avoid conflicts, duplications,
gaps, or other conditions that would jeopardize an orderly pattern in
the regulation of agreement material on a nationwide basis. Such
Agreement State program elements should embody the essential objective
of the corresponding Commission program elements. Agreement State
program elements may be more restrictive than Commission program
elements; however, they
[[Page 33126]]
should not be so restrictive as to prohibit a licensed activity.
D. Category D--Program Elements Not Required for Compatibility
An Agreement State has the flexibility to adopt and implement
program elements within the State's jurisdiction that are not addressed
by the NRC, or program elements not required for compatibility (i.e.,
those NRC program elements not assigned a Compatibility A, B, or C).
However, such program elements of an Agreement State relating to
agreement material should:
(1) Be compatible with those of the Commission (i.e., should not
create conflicts, duplications, gaps, or other conditions that would
jeopardize an orderly pattern in the regulation of agreement material
on a nationwide basis);
(2) Not preclude, or effectively preclude, a practice \4\ in the
national interest without an adequate public health and safety or
environmental basis related to radiation protection; and
---------------------------------------------------------------------------
\4\ For the purposes of this Policy Statement, ``practice''
means a use, procedure, or activity associated with the application,
possession, use, storage, or disposal of agreement material. The
term ``practice'' is used in a broad and encompassing manner in this
Policy Statement but does not include economic considerations. The
term encompasses both general and specific activities involving the
use of agreement materials.
---------------------------------------------------------------------------
(3) Not preclude, or effectively preclude, the ability of the
Commission to evaluate the effectiveness of the NRC and Agreement State
programs for agreement material with respect to protection of public
health and safety.
E. Category NRC--Areas of Exclusive NRC Regulatory Authority
These are program elements that address areas of regulation that
cannot be relinquished to Agreement States pursuant to the AEA or
provisions of Title 10 of the Code of Federal Regulations. However, an
Agreement State may inform its licensees of these NRC provisions
through a mechanism that is appropriate under the State's
administrative procedure laws as long as the State adopts these
provisions solely for the purposes of notification, and does not
exercise any regulatory authority as a result.
Summary and Conclusions
To foster and enhance a coherent and consistent nationwide program
for the regulation of agreement material, the Commission encourages
Agreement States to adopt and implement program elements that are
patterned after those adopted and implemented by the Commission.
However, the fact that an Agreement State's program is compatible with
that of the Commission does not affect that State's obligation to
maintain an adequate program as described in this Policy Statement.
By adopting the criteria for adequacy and compatibility as
discussed in this Policy Statement, the Commission will provide
Agreement States a broad range of flexibility in the administration of
individual programs. Recognizing the fact that Agreement States have
responsibilities for radiation sources other than agreement material,
the Commission allows Agreement States to fashion their programs so as
to reflect specific State needs and preferences.
The Commission will minimize the number of NRC regulatory
requirements that the Agreement States will be requested to adopt in an
identical manner to maintain compatibility. The expectation is that
these requirements will be limited. Requirements in these compatibility
categories allow the Commission to ensure that an orderly pattern for
the regulation of agreement material exists nationwide. The Commission
believes that this approach achieves a proper balance between the need
for Agreement State flexibility and the need for coordinated and
compatible regulation of agreement material across the country.
V. Proposed Revisions to Statement of Principles and Policy for the
Agreement State Program
A. Statement of Principles and Policy for the Agreement State Program
Purpose
The purpose of this Statement of Principles and Policy for the
Agreement State Program is to clearly describe the respective roles and
responsibilities of the NRC and States in the administration of
programs carried out under Section 274 of the AEA of 1954, as amended.
Section 274 provides broad authority for the NRC to establish Federal
and State cooperation in the administration of regulatory programs for
the protection of public health and safety in the industrial, medical,
commercial, and research uses of nuclear materials.
This Policy Statement addresses the Federal-State interaction under
the AEA: (1) to establish and maintain agreements with States under
Section 274b. that provide for discontinuance by the NRC, and the
assumption by the State, of responsibility for administration of a
regulatory program for the safe and secure use of byproduct, source,
and small quantities of special nuclear material; and (2) ensure that
post-agreement interactions among the NRC and Agreement State radiation
control programs are coordinated, compatible, and continue to provide
adequate protection of public health and safety.
Section 274 of the AEA provides for a special Federal-State
regulatory framework for the control of byproduct, source, and small
quantities of special nuclear material as identified by Section 274b.
of the AEA. The NRC, by agreement with a State, relinquishes its
authority under Section 274 of the AEA over practices involving some or
all of these materials. The material over which the State receives
regulatory authority under such agreements is hereinafter termed
``agreement material.''
The NRC and Agreement State radiation control programs maintain
regulatory oversight for the safe and secure handling, use, and storage
of agreement material. These programs have always included the security
of nuclear materials as an integral part of their health and safety
mission as it relates to minimizing the risk of exposure to workers and
the public. Following the events of September 11, 2001, the NRC's
regulatory oversight has included developing and implementing enhanced
security measures. For the purposes of this policy statement, public
health and safety includes these enhanced security measures.
This Policy Statement establishes principles, objectives, and goals
that the Commission expects will be reflected in the implementing
guidance and programs of the NRC and Agreement States to meet their
respective program responsibilities and that should be achieved in the
administration of these programs.
This Policy Statement is intended solely as guidance for the
Commission and the Agreement States in the implementation of the
Agreement State program. This Policy Statement does not itself impose
legally binding requirements on the Agreement States. In addition,
nothing in this Policy Statement expands the legal authority of
Agreement States beyond that already granted to them by Section 274 of
the AEA and other relevant legal authority. Implementation procedures
adopted pursuant to this Policy Statement shall be consistent with the
legal authorities of the Commission and the Agreement States.
Statement of Legislative Intent
The AEA did not initially specify a role for the States in
regulating the use of nuclear materials. Many States were concerned as
to what their responsibilities in this area might be and expressed
interest in seeing that the
[[Page 33127]]
boundaries of Federal and State authority were clearly defined. This
need for clarification was particularly important in view of the fact
that although the Federal Government retained sole responsibility for
protecting public health and safety from the radiation hazards of
byproduct, source, and special nuclear material, the responsibility for
protecting the public from the radiation hazards of other sources such
as x-ray machines and radium had been borne for many years by the
States.
Consequently, in 1959 Congress enacted Section 274 of the AEA to
establish a statutory framework under which States could assume certain
regulatory jurisdiction over byproduct, source, and special nuclear
material in quantities less than a critical mass. The primary purpose
of the legislation was to authorize the Commission to relinquish its
regulatory authority over the use of these materials and for assumption
of this authority by the States. The Commission retained regulatory
authority over the licensing of certain facilities and activities such
as nuclear reactors, larger quantities of special nuclear material, the
export and import of nuclear materials, and matters related to common
defense and security.
In considering the legislation, Congress recognized that the
Federal Government would need to assist the States to ensure that they
developed the capability to exercise their regulatory authority in a
competent and effective manner. Accordingly, the legislation authorized
the Commission to provide training and other services to State
officials and employees. However, in rendering this assistance,
Congress did not intend that the Commission would provide any grants to
a State for the administration of a State regulatory program. This was
fully consistent with the objectives of Section 274 to qualify States
to assume independent regulatory authority over certain defined areas
of regulatory jurisdiction and to permit the Commission to discontinue
its regulatory responsibilities in those areas.
In order to relinquish its authority to a particular State, the
Commission must find that program is compatible with the Commission's
program for the regulation of agreement materials and that the State
program is adequate to protect public health and safety. In addition,
the Commission has an obligation, pursuant to Section 274j. of the AEA,
to review existing Agreement State programs periodically to ensure
continued adequacy and compatibility. Section 274j. of the AEA provides
that the NRC may terminate or suspend all or part of its agreement with
a State if the Commission finds that such termination is necessary to
protect public health and safety or that the State has not complied
with the provisions of Section 274j. In these cases, the Commission
must offer the State reasonable notice and opportunity for a hearing.
In addition, the Commission may temporarily suspend all or part of an
agreement in the case of an emergency situation.
B. Principles of Program Implementation and Program Assessment
The NRC is responsible for ensuring that the regulatory programs of
the NRC and the Agreement States collectively establish a coherent
nationwide effort for the control of agreement material. The basic
elements of such regulatory programs include principles of good
regulation in program administration and the ability to assess program
performance on a consistent and systematic basis; the ability to ensure
adequate protection of public health and safety including security of
these nuclear materials; compatibility in areas of national interest;
and sufficient flexibility to accommodate local needs and conditions.
Each of these elements is reflected and addressed in specific sections
of this Policy Statement.
1. Good Regulation Principles
In 1991, the Commission adopted ''Principles of Good Regulation''
to serve as a guide to both agency decision making and to individual
behavior as NRC employees. There are five Principles of Good
Regulation: independence, openness, efficiency, clarity, and
reliability. Adherence to these principles has helped to ensure that
the NRC's regulatory activities have been of the highest quality,
appropriate, and consistent. The ''Principles of Good Regulation''
recognize that strong, vigilant management and a desire to improve
performance are prerequisites for success, for both regulators and the
regulated industry. The NRC's implementation of these principles has
served the public, the Agreement States, and the regulated community
well. The Commission further suggests that such principles may be
useful as a part of a common culture that the NRC and the Agreement
States share as co-regulators. Accordingly, the Commission encourages
each Agreement State to adopt a similar set of principles for use in
its own regulatory program.
For a regulator to achieve independence nothing but the highest
possible standards of ethical performance and professionalism should
influence regulation. However, independence does not imply isolation.
All available facts and opinions must be sought openly from licensees
and other interested members of the public. The many and possibly
conflicting public interests involved must be considered. Final
decisions must be based on objective, unbiased assessments of all
information and must be documented with reasons explicitly stated.
Nuclear regulation is the public's business and it must be
transacted publicly and candidly. The public must be informed about and
have the opportunity to participate in the regulatory processes as
required by law. Open channels of communication must be maintained with
Congress, other government agencies, licensees, and the public, as well
as with the international nuclear community.
The American taxpayer, the rate-paying consumer, and licensees are
all entitled to the best possible management and administration of
regulatory activities. The highest technical and managerial competence
is required and must be a constant agency goal. The NRC must establish
means to evaluate and continually upgrade its regulatory capabilities.
Regulatory activities should be consistent with the degree of risk
reduction they achieve. Where effective alternatives are available, the
option which minimizes the use of resources should be adopted.
Regulatory decisions should be made without undue delay.
Regulations should be coherent, logical, and practical. There
should be a clear nexus between regulations and agency goals and
objectives whether explicitly or implicitly stated. Agency positions
should be readily understood and easily applied.
Regulations should be based on the best available knowledge from
research and operational experience. Systems interactions,
technological uncertainties, and the diversity of licensees and
regulatory activities must all be taken into account so that risks are
maintained at an acceptably low level. Once established, regulation
should be perceived to be reliable and not unjustifiably in a state of
transition. Regulatory actions should always be fully consistent with
written regulations and should be promptly, fairly, and decisively
administered so as to lend stability to the nuclear operational and
planning processes. Failure to adhere to these principles of good
regulation in the conduct of operations should be a sufficient reason
for a regulatory program to self-initiate program changes that will
result in needed improvements. All involved should
[[Page 33128]]
welcome expressions of concern that indicate a program may not be
operating in accordance with these principles and revise their program
to more completely reflect these principles.
It is not intended that these principles of good regulation be
established as formal criteria against which the NRC and Agreement
State programs would be assessed. Rather, these principles should be
incorporated into the day-to-day operational fabric of the NRC and
Agreement State materials programs. These principles should be used in
the formulation of policies and programs, implementation of those
policies and programs, and assessments of program effectiveness.
Application of these principles will ensure that complacency will be
minimized, that adequate levels of protection of public health and
safety are being provided, and that Government employees tasked with
the responsibility for these Federal and State regulatory programs
serve the public in an effective, efficient, and responsive manner.
These principles are primarily for the use of the NRC and Agreement
State materials program managers and staff in the self-assessment of
their respective programs and to use in the establishment of goals and
objectives for the continual improvement of their respective programs.
Deficiencies identified during the conduct of the NRC Region and
Agreement State formal program performance reviews may indicate that
the program is not adhering to these principles of good regulation. The
organization being assessed should factor the need for these principles
into its actions to address identified deficiencies.
2. Coherent Nationwide Effort
The mission of the NRC is to assure that civilian use of nuclear
materials in the United States is carried out with adequate protection
of public health and safety. NRC acknowledges its responsibility,
shared with the Agreement States, to ensure that the regulatory
programs of the NRC and the Agreement States collectively establish a
coherent nationwide effort for the control of agreement material. The
basic elements of such regulatory programs include the ability to
ensure adequate protection of public health and safety, compatibility
in areas of national interest, sufficient flexibility to accommodate
local needs and conditions, the ability to assess program performance
on a consistent and nationwide basis, and principles of good regulation
in program administration.
3. Adequate To Protect Public Health and Safety
The NRC and the Agreement States have the responsibility to ensure
adequate protection of public health and safety in the administration
of their respective regulatory programs controlling the safe and secure
use of agreement materials. Accordingly, the NRC and Agreement State
programs shall possess the requisite supporting legislative authority,
implementing organization structure and procedures, and financial and
human resources to effectively administer a radiation control program
that ensures adequate protection of public health and safety.
4. Compatible in Areas of National Interest
The NRC and the Agreement States have the responsibility to ensure
that consistent and compatible radiation control programs are
administered. Such radiation control programs should be based on a
common regulatory philosophy including the common use of definitions
and standards. They should not only be effective and cooperatively
implemented by the NRC and the Agreement States, but also should
provide uniformity and consistency in program areas having national
significance.
Such areas include those affecting interstate commerce, movement of
goods and provision of services, security of Category 1 and 2
radioactive sources, and safety reviews for the manufacture and
distribution of sealed sources and devices. Also necessary is the
ability to communicate using a nationally accepted set of terms with
common understanding, the ability to ensure an adequate level of
protection of public health and safety that is consistent and stable
across the nation, and the ability of the NRC and each Agreement State
to evaluate the effectiveness of the NRC and Agreement State programs
for the regulation of agreement material with respect to protection of
public health and safety.
5. Flexibility
With the exception of those compatibility areas where all programs
should be essentially identical, to the extent possible, Agreement
State radiation control programs for agreement materials should be
provided with flexibility in program implementation to accommodate
individual State preferences, State legislative direction, and local
needs and conditions. However, the exercise of such flexibility should
not preclude, or effectively preclude, a practice authorized by the
AEA, and in the national interest. That is, a State would have the
flexibility to design its own program, including incorporating more
stringent, or similar, requirements provided that the requirements for
adequacy are still met and compatibility is maintained, and the more
stringent requirements do not preclude or effectively preclude a
practice in the national interest without an adequate public health and
safety or environmental basis related to radiation protection.
C. New Agreements
Section 274 of the AEA requires that once a decision to request
Agreement State status is made by the State, the Governor of that State
must certify to the NRC that the State desires to assume regulatory
responsibility and has a program for the control of radiation hazards
adequate to protect public health and safety with respect to the
materials within the State covered by the proposed agreement. This
certification will be provided in a letter to the NRC that includes a
number of documents in support of the certification. These documents
include the State's enabling legislation, the radiation control
regulations, a narrative description of the State program's policies,
practices, and procedures, and a proposed agreement.
The NRC has published criteria describing the necessary content
these documents are required to cover. The NRC reviews the request and
publishes notice of the proposed agreement in the Federal Register to
provide an opportunity for public comment. After consideration of
public comments, if the Commission determines that the State program is
adequate and compatible, and approves the agreement, a formal agreement
document is signed by the Governor and the Chairman of the NRC.
D. Program Assistance
The NRC will offer training and other assistance to States, such as
assistance in developing regulations and program descriptions to help
individual States prepare for entrance into agreements and to help them
prior to the assumption of regulatory authority. Following assumption
of regulatory authority by a new Agreement State, to the extent
permitted by resources, the NRC may provide training opportunities and
other assistance such as review of proposed regulatory changes to help
States administer their regulatory responsibilities. The NRC may also
use its best efforts to provide specialized technical assistance to
Agreement States to address unique or complex licensing,
[[Page 33129]]
inspection, and limited enforcement issues. In areas where Agreement
States have particular expertise or are in the best position to provide
immediate assistance to the NRC or other Agreement States, they are
encouraged to do so. In addition, the NRC and Agreement States will
keep each other informed about relevant aspects of their programs. The
NRC will provide an opportunity for Agreement States to have early and
substantive involvement in rulemaking, policy, and guidance development
activities. Agreement States should provide a similar opportunity to
the NRC to make it aware of, and to provide the opportunity to review
and comment on, proposed changes in regulations and significant changes
to Agreement State programs, policies, and regulatory guidance.
If an Agreement State experiences difficulty in program
administration, the Commission would use its best efforts to assist the
State in maintaining the effectiveness of its radiation control
program. Such assistance could address an immediate difficulty or a
chronic difficulty affecting the State's ability to discharge its
responsibility to continue to ensure adequate protection of public
health and safety. Under certain conditions Agreement States can also
voluntarily return part or all of its Agreement State program, e.g.,
Sealed Source and Device evaluations and uranium recovery regulatory
oversight (SECY-95-0136).
E. Performance Evaluation
Under Section 274 of the AEA, as amended, the Commission retains
authority for ensuring that Agreement State programs continue to
provide adequate protection of public health and safety. In fulfilling
this statutory responsibility, the NRC will periodically evaluate
Agreement State radiation control programs to determine whether the
programs are adequate and compatible prior to entrance into a Section
274b. agreement and ensure they continue to be adequate and compatible
after an agreement becomes effective.
The Commission, in cooperation with the Agreement States,
established and implemented the Integrated Materials Performance
Evaluation Program (IMPEP). The IMPEP is a performance evaluation
process that provides the NRC and Agreement State management with
systematic, integrated, and reliable evaluations of the strengths and
weaknesses of their respective radiation control programs and
identification of areas needing improvement. Performance indicators are
used to evaluate and ensure that regulatory programs are adequate to
protect public health and safety and that Agreement State programs are
compatible with the NRC's program. The IMPEP process employs a
Management Review Board (MRB), composed of senior NRC managers and an
Agreement State Liaison to make a determination of program adequacy and
compatibility.
As a part of the performance evaluation process, the NRC will take
any necessary actions to help ensure that Agreement State radiation
control programs remain adequate and compatible. These actions may
include more frequent IMPEP reviews of Agreement State programs and
provision of assistance to help address weaknesses or areas needing
improvement within an Agreement State program. Enhanced oversight,
suspension, or termination of an agreement may be considered for
serious program deficiencies or emergencies. The NRC's actions will be
based on a well-defined and predictable process and a performance
evaluation program that will be consistently and fairly applied.
F. Levels of Agreement State Program Review Findings
The following discussion outlines the nature of the NRC findings
regarding the NRC's Agreement State review process.
1. Adequacy
Finding 1--Adequate To Protect Public Health and Safety
If the NRC finds that an Agreement State program has met all of the
IMPEP review criteria or that only minor deficiencies exist, the NRC
would find that the Agreement State's program is adequate to protect
public health and safety.
Finding 2--Adequate To Protect Public Health and Safety With
Improvement Needed
If the NRC finds that an Agreement State program protects public
health and safety, but is deficient in meeting some of the IMPEP review
criteria, the NRC may find that the Agreement State's program is
adequate with improvement needed. The NRC would consider in its
determination plans that the State has to address any of the
deficiencies noted during the review. In cases where less significant
Agreement State deficiencies previously identified have been
uncorrected for a significant period of time, the NRC may also find
that the program is adequate with improvement needed.
Finding 3--Not Adequate To Protect Public Health and Safety
If the NRC finds that an Agreement State program is significantly
deficient in some or all of the review criteria, the NRC would find
that the Agreement State's program is not adequate to protect public
health and safety.
2. Compatibility
Finding 1--Compatible
If the NRC determines that an Agreement State program contains all
required NRC program elements for compatibility, or only minor
discrepancies exist, the program would be found compatible.
Finding 2--Not Compatible
If the NRC determines that an Agreement State has a program that
disrupts the orderly pattern of regulation among the collective
regulatory efforts of the NRC and other Agreement States (i.e., creates
conflicts, gaps, or duplication in regulation), the program would be
found not compatible.
G. NRC Actions as a Result of These Findings
The following discussion outlines the options available to the NRC
as a result of making any of the above findings. The appropriate action
will be determined on a case-by-case basis by the MRB. Subsequent to an
Agreement State program review, the findings would be recounted in a
letter to senior level State management.
If the NRC finds that a State program is adequate and compatible,
no further action would be required, except a response by the State to
any recommendations.
If serious performance issues are noted during the program review,
NRC may increase the frequency of contacts with the State to keep
abreast of developments and conduct onsite follow-up reviews to assure
that progress is being made on correcting those issues. Circumstances
that can lead to more frequent contact between the NRC and the
Agreement State program include the following: identification of
serious program deficiencies, previously identified deficiencies that
have gone uncorrected for a significant period of time, and/or
deficiencies in adopting required compatibility program elements.
If findings of subsequent reviews show that the State has taken
appropriate corrective actions and that these actions have shown a
sustained improvement in performance, the MRB will determine whether
the status of an
[[Page 33130]]
Agreement State program may be moved to another level of oversight. If
the MRB finds that all deficiencies have been corrected, it may
determine that the Agreement State program is adequate and/or
compatible.
Options to address serious performance issues include one or more
of the following actions: monitoring, heightened oversight, probation,
suspension, and termination.
1. Monitoring
Monitoring is an informal process that allows the NRC to maintain
an increased level of communication with an Agreement State Program
through periodic (usually bimonthly) calls between the NRC and State
managers/staff. Monitoring is implemented in cases where weaknesses in
a program have resulted in, or are likely to result in, less than
satisfactory performance for one or more performance indicators.
Monitoring may be considered based on results of a routine IMPEP
review, a follow-up IMPEP review, a periodic meeting or other
interaction with the Agreement State program. In cases where one or
more performance indicators remain less than satisfactory or further
degraded, the MRB will consider placing a State on Heightened
Oversight.
2. Heightened Oversight
Heightened Oversight is a formalized process that allows the NRC to
maintain an increased level of communication with an Agreement State
usually through monthly calls between the NRC and State managers/staff.
Heightened Oversight is implemented in cases where significant program
weaknesses are identified, but are not determined to be serious enough
to find the program inadequate to protect public health and safety. In
addition to the monthly calls, a State placed on Heightened Oversight
is required to submit a Program Improvement Plan describing actions to
be taken by the State to address the program deficiencies, including
specific goals and milestones. The Program Improvement Plan allows the
NRC to monitor the actions being taken and the implementation schedule
for those actions that address the weaknesses identified based on the
results of an IMPEP review, a periodic meeting, or other interaction
with the Agreement State program. If programmatic weaknesses are
serious enough to find the program inadequate to protect public health
and safety, or if weaknesses continue throughout the period of
heightened oversight, the MRB may elect to make a recommendation to the
Commission to place the Agreement State on probation.
3. Probation
Probation is a formalized process, requiring Commission approval
and notification to the Agreement State's governor, which allows the
NRC to maintain an increased level of communication with an Agreement
State program. Probation is considered in cases where the State's
program is found to be not adequate to protect public health and
safety, or not compatible with the NRC's program. An Agreement State
may also be placed on probation when it has not addressed previously
identified program weaknesses. The process allows the NRC to monitor
the actions being taken by the State to correct the identified
weaknesses and the implementation schedule for those actions.
Probation would include all the requirements for Heightened
Oversight previously described. In addition, the NRC would communicate
its findings to a higher level of State management. Written
notification of probationary status would be sent to the Governor of
the State, a notice published in the Federal Register, and a press
release issued. Notice would also be given to the State's Congressional
delegation, the appropriate Congressional committee(s), and all
Agreement and non-Agreement States.
If requested, the NRC may provide technical support for the
maintenance of the regulatory program. The probationary period would
normally be one year or less. At the end of that time, if the State has
not addressed the deficiencies, the NRC may extend the probationary
period or institute suspension or termination proceedings.
4. Suspension
Section 274j. of the AEA gives the Commission authority to suspend
all or part of its agreement with a State if the suspension is required
to protect public health and safety, or if the State has not complied
with one or more of the requirements of Section 274 of the AEA. In
cases where program deficiencies are such that the Commission must take
action to protect public health and safety, or if the program has not
complied with one or more of the requirements of Section 274 of the
AEA, the Commission may suspend all or part of its agreement with the
State. In cases where a State has failed to respond in an acceptable
manner during the probationary period, suspension may be considered.
Before reaching a final decision on suspension, the Commission will
notify the State and provide the State an opportunity for a hearing on
the proposed suspension. Notice of the proposed suspension will also be
published in the Federal Register. Suspension, rather than termination,
would be the preferred option in those cases where the State provides
evidence that the program deficiencies are temporary and that the State
is committed to correcting the deficiencies that led to the suspension.
In addition to the normal suspension authority, Section 274j(2) of
the AEA also addresses emergency situations and gives the Commission
authority to temporarily suspend all or part of its agreement with a
State without notice or hearing if an emergency situation exists
requiring immediate action to protect public health and safety, and the
State has failed or is unable to take necessary action within a
reasonable time.
In cases where the Commission decides to suspend the agreement, the
NRC would communicate its findings to a higher level of State
management. The NRC would issue an order temporarily suspending all or
part of the 274b. agreement and an order to State licensees notifying
them of the temporary suspension of all or part of the 274b. agreement.
Written notification of suspension would be sent to the Governor of the
State, a notice published in the Federal Register, and a press release
issued. Notice would also be given to the State's Congressional
delegation, the appropriate Congressional committee(s), and all
Agreement and non-Agreement States.
5. Termination
Section 274j. of the AEA gives the Commission authority to
terminate all or part of its agreement with a State if such termination
is required to protect public health and safety, if the State program
has not complied with one or more of the requirements of Section 274 of
the AEA (e.g., is found to be not compatible with the Commission's
program for regulation of agreement materials), or by State request.
When the Commission finds such significant program deficiencies, the
Commission would institute formal proceedings to terminate its
agreement with the State. In cases where the State has requested
termination of the agreement, notice and opportunity for a hearing are
not necessary.
In cases where a State has failed to respond in an acceptable
manner during the probationary period and there is no prospect for
improvement, termination will be considered. Before reaching a final
decision on termination, the
[[Page 33131]]
Commission will notify the State and provide the State an opportunity
for a hearing on the proposed termination.
Also, notice of the proposed termination will be published in the
Federal Register. There may be cases where termination will be
considered even though the State program has not been placed on
probation.
H. Program Funding
Section 274 of the AEA does not allow Federal funding for the
administration of Agreement State radiation control programs. Section
274 of the AEA permits the NRC to offer training and other assistance
to a State in anticipation of entering into an Agreement with the NRC.
However, it is the NRC policy not to fund the establishment of new
Agreement State programs. Regarding training, given the importance in
terms of public health and safety of having well trained radiation
control program personnel, the NRC may offer certain relevant training
courses and notify Agreement State personnel of their availability.
I. Regulatory Development
The NRC and Agreement States will cooperate in the development of
both new and revised regulations and policies. Agreement States will
have early and substantive involvement in the development of
regulations affecting protection of public health and safety and of
policies affecting administration of the Agreement State program. The
NRC and Agreement States will keep each other informed about their
individual regulatory requirements (e.g., regulations or license
conditions) and the effectiveness of those regulatory requirements so
that each has the opportunity to make use of proven regulatory
approaches to further the effective and efficient use of resources.
The Conference of Radiation Control Program Directors, Inc. (CRCPD)
assists its members in their efforts to protect the public, radiation
workers, and patients from unnecessary radiation exposure. CRCPD's
mission, in part, is ``to promote consistency in addressing and
resolving radiation protection issues.'' The CRCPD provides a forum for
centralized communication on radiation protection matters between the
States and the Federal Government and between individual States. One
product of this forum is the development of the CRCPD Suggested State
Regulations for use by its members. The NRC also reviews Suggested
State Regulations for compatibility.
J. Program Evolution
The NRC-Agreement State program is dynamic and the NRC and
Agreement States will continue to jointly assess the NRC and Agreement
State programs for the regulation of agreement materials to identify
specific changes that should be considered based on experience or to
further improve overall performance and effectiveness. The changes
considered may include possible legislative changes. The program should
also include the formal sharing of information and views such as
briefings of the Commission by the Agreement States.
VI. Topics for Additional Comment
The NRC is requesting additional comments on key topics in response
to direction received from the Commission on the development of both
Policy Statements (SRM-SECY-12-0112, ``Policy Statements in Agreement
State Programs''). Specifically, the NRC is seeking comments on the
following topics:
1. Section IV. Policy Statement on Adequacy and Compatibility of
Agreement State Programs, Item 1.B. Compatibility Category B
(1) To clarify the meaning of a ``significant transboundary
implication,'' the NRC is proposing to define a significant
transboundary implication as ``one which crosses regulatory
jurisdictions, has a particular impact on public health and safety, and
needs to be addressed to ensure uniformity of regulation on a
nationwide basis.'' However, the NRC recognizes that the use of the
word ``particular'' can be vague and cause confusion. The NRC is
requesting specific comments on the proposed draft definition of
``significant transboundary implication'' and whether the word
``particular'' should be replaced with the phrase ``significant and
direct.''
(2) Program elements with significant transboundary implications
are illustrated by examples in the 1997 version of the Policy
Statement.
(3) The NRC staff concluded the examples listed are not all-
inclusive and could lead to misinterpretation by stakeholders,
Agreement States, and the NRC staff. The NRC staff is seeking
additional comment on whether or not the examples should be retained in
this section of the policy statement.
(4) The NRC is requesting comments on the description of
Compatibility Category B as written in Section IV. of this notice and
whether or not the movement of goods and services, which historically
has been a main factor in determining whether an issue has transboundry
implications, should be considered in the definition of significant
transboundry implication.
(5) The NRC is requesting comments on whether or not economic
factors should be a consideration when making a Compatibility Category
B determination. The NRC believes that health and safety should be the
primary consideration in making a Compatibility B determination and
that economic factors should not be a consideration.
(6) The NRC is requesting comments on alternative versions of
wording regarding what types of program elements will be assigned a
Compatibility Category B designation as well as how limited in number
these will be. The original Policy Statement published in 1997 stated,
in part: ``The Commission will limit this category to a small number of
program elements (e.g., transportation regulations and sealed source
and device registration certificates) that have significant
transboundary implications.'' The Working Group proposed keeping the
language in the 1997 version of the Policy Statement; however, some
believed that this statement could be interpreted to imply that the
Commission is limited in its ability to assign rules in this
compatibility category. Therefore, alternative language was proposed as
follows: ``The Commission will limit this category to program elements
that have significant transboundary implications. The Commission
expects that these will be limited in number.'' Some members of the
working group disagreed with this alternative language and believed
that the original language should be retained. The details of this
discussion are in Enclosure 3 of SECY-12-0112, ``Policy Statements on
Agreement State Programs.'' In summary, some members of the Working
Group believed that the original language in the 1997 version of the
Policy Statement was not intended to dictate the Commission's authority
but rather was to remind those staff proposing designations of
compatibility B to the Commission for consideration that program
elements of this designation should be few as opposed to many and
should involve only significant transboundary implications.
Additionally, by removing the distinction that there should be a small
number of program elements, it deemphasizes the idea that Agreement
States should be given flexibility when addressing the majority of
program elements necessary for a compatible program.
[[Page 33132]]
2. Section IV. Policy Statement on Adequacy and Compatibility of
Agreement State Programs, Item. Summary and Conclusions
The NRC is requesting comments on alternative versions of wording
regarding the expectation on the number of regulatory requirements that
Agreement States will be requested to adopt in an identical manner to
maintain compatibility. This language would cover all regulatory
requirements as compatibility category A, B, and C. (Agreement States
are required to adopt regulatory requirements listed as Health and
Safety to ensure their program is adequate to protect public health and
safety, but not for compatibility purposes). In the third paragraph
under ``Summary and Conclusions'' of the original Policy Statement
published in 1997, it stated, in part: ``The Commission will minimize
the number of NRC regulatory requirements that the Agreement States
will be requested to adopt in an identical manner to maintain
compatibility.'' The Working Group proposed keeping this sentence as
written; however, some members of the Working Group believed that that
this sentence could be interpreted to imply that there is a requirement
that the Commission minimize such requests to Agreement States, rather
than a statement that reflects the expectation that situations
justifying such requests will not arise frequently. The sentence was
revised as follows: ``The Commission will identify regulatory
requirements that the Agreement States will be requested to adopt in an
identical manner to maintain compatibility. The expectation is that
these requirements will be limited.'' Some members of the Working Group
disagreed with this revision and believed that the original language
should be retained. The details of this discussion are in Enclosure 3
of SECY-12-0112, ``Policy Statements on Agreement State Programs.'' In
summary, some members of the Working Group believed that the original
text places emphasis on the effort to minimize unnecessary burden on
the Agreement States' means to accomplish the same goals as the NRC.
Additionally, the suggested changes do not encourage careful
consideration as to whether there are other possible options to meet
the same intended goal.
3. Performance Based Approach for Determining Compatibility
Currently, Agreement States are afforded some flexibility to use
approaches other than rulemaking, such as license conditions or orders,
to implement requirements. The NRC staff is seeking additional input on
whether a performance-based approach for determining compatibility of
an Agreement State's radiation control program should be developed.
Agreement States could be afforded additional flexibility to use other
approaches to implement requirements. A performance-based approach
would not rely on a requirement to adopt within 3 years from the
effective date of the NRC regulation in order to determine
compatibility of an Agreement State program. In a separate Commission
vote paper, the NRC staff will use input from comments received on this
topic to create a recommendation and an implementation plan to provide
to the Commission for approval.
4. Adequacy Determinations of Agreement State Programs
The NRC staff is seeking additional input on whether: (1) a revised
set of performance metrics could be used to replace, supplement, or
expand upon IMPEP in determining adequacy of an Agreement State's
radiation control program; and (2) a single holistic determination can
be made that would accurately reflect the overall adequacy and
compatibility of a program. Given the current environment of limited
resources, it is imperative that the NRC be able to develop a clear set
of performance based metrics that consider the limitations of an
Agreement State program and provide increased flexibility without
compromising public health and safety. In a separate Commission vote
paper, the NRC staff will use input from comments received on this
topic to create a recommendation or series of recommendations for
Commission approval.
VI. Paperwork Reduction Act
This Policy Statement does not contain information collection
requirements that are subject to the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
Public Protection Notification
The NRC may not conduct or sponsor, and a person is not required to
respond to, a request for information or an information collection
requirement unless the requesting documents displays a currently valid
Office of Management and Budget control number.
Dated at Rockville, Maryland, this 28th day of May, 2013.
For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary for the Commission.
[FR Doc. 2013-13066 Filed 5-31-13; 8:45 am]
BILLING CODE 7590-01-P