Agreement State Program Policy Statement; Correction, 48535-48539 [2017-22514]
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[FR Doc. 2017–22543 Filed 10–17–17; 8:45 am]
BILLING CODE 7515–01–P
Agreement State Program Policy
Statement; Correction
Nuclear Regulatory
Commission.
ACTION: Revision to policy statement;
correction.
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AGENCY:
The correction is effective
October 18, 2017.
Attachment
DATES:
Please refer to Docket ID
NRC–2016–0094 when contacting the
NRC about the availability of
information regarding this document.
You may obtain publicly-available
information related to this document
using any of the following methods:
• Federal Rulemaking Web site: Go to
https://www.regulations.gov and search
for Docket ID NRC–2016–0094. Address
questions about NRC dockets to Carol
Gallagher; telephone: 301–415–3463;
email: Carol.Gallagher@nrc.gov. For
technical questions, contact the
individual listed in the FOR FURTHER
INFORMATION CONTACT section of this
document.
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ADDRESSES:
Jkt 244001
In the FR
on October 6, 2017, in FR Doc. 2017–
21542, please add the Agreement State
Program Policy statement.
The text of the Agreement State
Program Policy statement is attached.
SUPPLEMENTARY INFORMATION:
The U.S. Nuclear Regulatory
Commission (NRC) is correcting a notice
that was published in the Federal
Register (FR) on October 6, 2017,
regarding consolidation of two policy
SUMMARY:
17:50 Oct 17, 2017
For the Nuclear Regulatory Commission.
Helen Chang,
Acting Branch Chief, Rules, Announcements
and Directives Branch, Division of
Administrative Services, Office of
Administration.
Lance Rakovan, Office of Nuclear
Material Safety and Safeguards, U.S.
Nuclear Regulatory Commission,
Washington, DC 20555–0001; telephone:
301–415–2589, email: Lance.Rakovan@
nrc.gov.
[NRC–2016–0094]
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statements on the NRC’s Agreement
State programs. This action is necessary
to provide the policy statement revision
which was inadvertently left out of the
previously published FRN.
FOR FURTHER INFORMATION CONTACT:
NUCLEAR REGULATORY
COMMISSION
48535
Dated at Rockville, Maryland, this 12th day
of October 2017.
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Agreement State Program Policy Statement
A. Purpose
The purpose of this policy statement for
the Agreement State Program is to describe
the respective roles and responsibilities of
the U.S. Nuclear Regulatory Commission
(NRC) and Agreement States in the
administration of programs carried out under
Section 274 of the Atomic Energy Act of
1954, as amended (AEA).1 Section 274
provides broad authority for the NRC to
establish a unique Federal and State
relationship in the administration of
regulatory programs for the protection of
public health and safety in the industrial,
medical, commercial, and research uses of
agreement material. This policy statement
supersedes the September 1997 ‘‘Policy
Statement on Adequacy and Compatibility of
Agreement State Programs’’ and ‘‘Statement
of Principles and Policy for the Agreement
State Program.’’
This policy statement addresses the
Federal-State interaction under the AEA to
(1) establish and maintain agreements with
States under Subsection 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 use of agreement material; (2) ensure
that post-agreement interactions between the
NRC and Agreement State radiation control
programs are coordinated; and (3) ensure
Agreement States provide adequate
protection of public health and safety and
maintain programs that are compatible with
the NRC’s regulatory program.
Although not defined in the AEA, the
National Materials Program (NMP) is a term
used to describe the broad collective effort
within which both the NRC and the
Agreement States function in carrying out
their respective regulatory programs for
agreement material. The vision of the NMP
is to provide a coherent national system for
the regulation of agreement material with the
goal of protecting public health and safety
through compatible regulatory programs.
Through the NMP, the NRC and Agreement
States function as regulatory partners.
B. Background
This policy statement is intended solely as
guidance for the NRC 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
1 Subsection 274b. of the AEA authorizes the NRC
to enter into an agreement by which the NRC
discontinues and the State assumes regulatory
authority over some or all of these materials. The
material over which the State receives regulatory
authority under such agreement is termed
‘‘agreement material.’’
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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
pursuant to this policy statement shall be
consistent with the legal authorities of the
NRC and the Agreement States.
This policy statement presents the NRC’s
policy for determining the adequacy and
compatibility of Agreement State programs.
This policy statement clarifies the meaning
and use of the terms ‘‘adequate to protect
public health and safety’’ and ‘‘compatible
with the NRC’s regulatory program’’ as
applied to Agreement State programs. The
terms ‘‘adequate’’ and ‘‘compatible’’
represent fundamental concepts in the
Agreement State programs authorized in
1959 by Section 274 of the AEA. Subsection
274d. states that the NRC shall enter into an
Agreement under Subsection 274b. that
discontinues the NRC’s regulatory authority
over specified AEA radioactive materials and
activities within a State, provided that the
State’s program is adequate to protect public
health and safety and is compatible with the
NRC’s regulatory program. Subsection 274g.
authorizes and directs the NRC to cooperate
with States in the formulation of standards to
assure that State and NRC programs for
protection against hazards of radiation will
be coordinated and compatible. Subsection
274j.(1) requires the NRC to periodically
review the Agreements and actions taken by
States under the Agreements to ensure
compliance with the provisions of Section
274.
The NRC and Agreement State radiation
control programs maintain regulatory
authority for the safe and secure handling,
use, and storage of agreement material. These
programs have always included the security
of agreement material as an integral part of
their health and safety mission as it relates
to controlling and minimizing the risk of
exposure to workers and the public.
Following the events of September 11, 2001,
the NRC and Agreement States developed
and implemented enhanced security
measures. For the purposes of this policy
statement, public health and safety includes
the physical protection of agreement
material.
C. Statement of Legislative Intent
In 1954, the AEA did not initially specify
a role for the States in regulating the use of
nuclear material. Many States were
concerned as to what their responsibilities in
this area might be and expressed interest in
clearly defining the boundaries of Federal
and State authority over nuclear material.
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 AEA
radioactive materials—defined as byproduct,
source, and special nuclear material—the
States maintained the responsibility for
protecting the public from the radiation
hazards of other sources such as x-ray
machines and naturally occurring radioactive
material.
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Consequently, in 1959, Congress enacted
Section 274 of the AEA to establish a
statutory framework under which States
could assume, and the NRC could
discontinue, regulatory authority over
byproduct, source, and small quantities of
special nuclear material insufficient to form
a critical mass. The NRC continued to retain
regulatory authority over the licensing of
certain facilities and activities, including
nuclear reactors, quantities of special nuclear
material sufficient to form a critical mass, the
export and import of nuclear materials, and
matters related to common defense and
security.
The legislation did not authorize a
wholesale, immediate relinquishment or
abdication by the Commission 2 of its
regulatory responsibilities but only a gradual,
carefully considered turnover. 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 NRC to provide training, with
or without charge, and other services to State
officials and employees as the Commission
deems appropriate. However, in rendering
this assistance, Congress did not intend that
the NRC 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 under their
Agreement and to permit the NRC to
discontinue its regulatory responsibilities in
those areas.
In order to discontinue its authority, the
NRC must find that the State program is
adequate to protect public health and safety
and compatible with the NRC program for the
regulation of agreement material. In addition,
the NRC has an obligation, pursuant to
Subsection 274j. of the AEA, to periodically
review existing Agreement State programs to
ensure continued adequacy and
compatibility. Subsection 274j. of the AEA
provides that the NRC may terminate or
suspend all or part of its agreement with a
State if the NRC finds that such termination
is necessary to protect public health and
safety or that the State has not complied with
the provisions of Subsection 274j. In these
cases, the NRC must offer the State
reasonable notice and opportunity for a
hearing. In cases where the State has
requested termination of the agreement,
notice and opportunity for a hearing are not
necessary. In addition, the NRC may
temporarily suspend all or part of an
agreement in the case of an emergency
situation.
D. Program Implementation
1. Implementation of the Agreement State
Program is described below and includes (a)
Principles of Good Regulation; (b)
performance evaluation on a consistent and
systematic basis; (c) the responsibility to
2 For the purposes of this policy statement,
‘‘Commission’’ means the five member Commission
or a quorum thereof sitting as a body, as provided
by Section 201 of the Energy Reorganization Act of
1974 (42 U.S.C. 5841).
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ensure adequate protection of public health
and safety, including physical protection of
agreement material; (d) compatibility in areas
of national interest; and (e) sufficient
flexibility in program implementation and
administration to accommodate individual
State needs.
i. Principles of Good Regulation
In 1991, the Commission adopted the
‘‘Principles of Good Regulation’’ to serve as
a guide to both agency decision making and
the individual behavior of 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 and are 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. Such
principles are useful as a part of a common
culture of the NMP that the NRC and the
Agreement States share as co-regulators.
Accordingly, the NRC encourages each
Agreement State to adopt a similar set of
principles for use in its own regulatory
program. These principles should be
incorporated into the day-to-day operational
fabric of the NMP.
ii. Performance Evaluation
To ensure that Agreement State programs
continue to provide adequate protection of
public health and safety and are compatible
with the NRC’s regulatory program, periodic
program evaluation is needed. The NRC, 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 and integrated evaluations of the
strengths and weaknesses of their respective
radiation control programs and identification
of areas needing improvement.
iii. 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, including physical protection of
agreement material. 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.
iv. Compatible in Areas of National Interest
The NRC and the Agreement States have
the responsibility to ensure that the radiation
control programs are compatible. Such
radiation control programs should be based
on a common regulatory philosophy
including the common use of definitions and
standards. The programs should be effective
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and cooperatively implemented by the NRC
and the Agreement States and also should
provide uniformity and achieve common
strategic outcomes in program areas of
national significance.
Such areas include aspects of licensing,
inspection and enforcement, response to
incidents and allegations, and safety reviews
for the manufacture and distribution of
sealed sources and devices. Furthermore,
communication using a nationally accepted
set of terms with common understanding,
ensuring an adequate level of protection of
public health and safety that is consistent
and stable across the nation, and evaluation
of the effectiveness of the NRC and
Agreement State programs for the regulation
of agreement material with respect to
protection of public health and safety are
essential to maintaining the NMP.
v. Flexibility
With the exception of those compatibility
areas where programs should be essentially
identical, Agreement State radiation control
programs have flexibility in program
implementation and administration to
accommodate individual State preferences,
State legislative direction, and local needs
and conditions. A State has the flexibility to
design its own program, including
incorporating more stringent, or similar,
requirements provided that the requirements
for adequate protection of public health and
safety are met and compatibility is
maintained. However, the exercise of such
flexibility should not preclude a practice
authorized by the AEA, and in the national
interest.
2. 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 that would be covered by the
proposed agreement. This certification will
be provided in a letter to the NRC that
includes supporting documentation. This
documentation includes the State’s enabling
legislation; the radiation control regulations;
the radiation control program staffing plan; a
narrative description of the State program’s
policies, practices, and procedures; and a
proposed agreement.
The NRC’s policy statement, ‘‘Criteria for
Guidance of States and NRC in
Discontinuance of NRC Regulatory Authority
and Assumption Thereof by States Through
Agreement’’ (46 FR 7540, January 23, 1981;
as amended by policy statements published
at 46 FR 36969, July 16, 1981; and 48 FR
33376, July 21, 1983), describes the required
content of these documents. 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 NRC determines that the
proposed State program is adequate for
protection of public health and safety and
compatible with the NRC’s regulatory
program, the Governor and Chairman of the
NRC sign the agreement.
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3. 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 their request for entering into an
Agreement and to help them prior to the
assumption of regulatory authority.
Following approval of the agreement and
assumption of regulatory authority by a new
Agreement State, to the extent permitted by
resources, the NRC may provide training and
offer other assistance (such as review of
proposed regulatory changes to help
Agreement States administer their regulatory
responsibilities). Nevertheless, it is the
responsibility of each Agreement State to
ensure that it has a sufficient number of
qualified staff to implement its program. If
the NRC is unable to provide the training, the
Agreement State will need to do so.
The NRC may also use its best efforts to
provide specialized technical assistance to
Agreement States to address unique or
complex licensing, inspection, incident
response, 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.
If an Agreement State experiences
difficulty in implementing its program, the
NRC will, to the extent possible, assist the
State in maintaining the effectiveness of its
radiation control program. Under certain
conditions, an Agreement State can also
voluntarily return all or part of its Agreement
State program.
4. Performance Evaluation
Under Section 274 of the AEA, the NRC
retains oversight authority for ensuring that
Agreement State programs provide adequate
protection of public health and safety and are
compatible with the NRC’s regulatory
program. In fulfilling this statutory
responsibility, the NRC will determine
whether the Agreement State programs are
adequate and compatible prior to entrance
into a Subsection 274b. agreement and will
periodically review the program to ensure it
continues to be adequate and compatible
after an agreement becomes effective.
To fulfill this responsibility, the NRC, in
cooperation with the Agreement States,
established and implemented the IMPEP. As
described in Management Directive 5.6
‘‘Integrated Materials Performance Evaluation
Program (IMPEP),’’ IMPEP is a performance
evaluation process that provides the NRC and
Agreement States with systematic, integrated,
and reliable evaluations of the strengths and
weaknesses of their respective radiation
control programs and identification of areas
needing improvement. The same criteria 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),
comprised of senior NRC staff members to
make a determination of program adequacy
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48537
and compatibility. An MRB also includes an
Agreement State liaison, provided by the
Organization of Agreement States (OAS), as
a non-voting member.
As a part of the performance evaluation
process, the NRC will take 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 providing assistance to help
address weaknesses or areas needing
improvement within an Agreement State
program. Monitoring, heightened oversight,
probation, suspension, or termination of an
agreement may be applied for certain
program deficiencies or emergencies (e.g. loss
of funding, natural or man-made events,
pandemic). The NRC’s actions in addressing
program deficiencies or emergencies will be
implemented through a well-defined process
that is consistently and fairly applied.
5. Program Funding and Training
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. Section 274 of the
AEA does not allow Federal funding for the
administration of Agreement State radiation
control programs. Given the importance to
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. These training
programs also help to ensure compatible
approaches to licensing and inspection and
thereby strengthen the NMP.
6. 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 and
guidance documents 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, orders, 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. 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, Agreement
States should inform the NRC of, and provide
the opportunity to review and comment on,
proposed changes in regulations and
significant changes to Agreement State
programs, policies, and regulatory guidance.
Two national organizations composed of
State radiation control program personnel
facilitate participation and involvement with
the development of regulations, guidance,
and policy. The OAS provides a forum for
Agreement States to work with each other
and with the NRC on regulatory issues,
including centralized communication on
radiation protection matters between the
Agreement States and the NRC. The
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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. One product of the
CRCPD is the Suggested State Regulations for
use by its members. The NRC reviews
Suggested State Regulations for
compatibility.
E. Adequacy and Compatibility
In accordance with Section 274 of the
AEA, any State that chooses to establish an
Agreement State program must provide for an
acceptable level of protection of public
health and safety. This is the ‘‘adequacy’’
component. The Agreement State must also
ensure that its program supports an overall
nationwide program in radiation protection.
This is the ‘‘compatibility’’ component.
By adopting the criteria for adequacy and
compatibility as discussed in this policy
statement, the NRC provides a broad range of
flexibility in the administration of individual
Agreement State programs. Recognizing the
fact that Agreement States have
responsibilities for radiation sources other
than agreement material, the NRC allows
Agreement States to fashion their programs to
reflect specific State needs and preferences.
The NRC will minimize the number of
NRC regulatory requirements that the
Agreement States will be requested to adopt
in an identical manner to maintain
compatibility. At the same time,
requirements in these compatibility
categories allow the NRC to ensure that an
orderly pattern for the regulation of
agreement material exists nationwide. The
NRC believes that this approach achieves a
proper balance between the need for
Agreement State flexibility and the need for
an NMP that is coherent and compatible in
the regulation of agreement material across
the country.
Program elements 3 for adequacy focus on
the protection of public health and safety
within a particular Agreement 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. Some program elements
for compatibility may also impact public
health and safety; therefore, they may also be
considered program elements for adequacy.
In identifying those program elements for
adequate and compatible programs, or any
changes thereto, the NRC staff will
coordinate with the Agreement States.
1. Adequacy
An ‘‘adequate’’ program includes those
program elements of a radiation control
regulatory program necessary to maintain an
acceptable level of protection of public
health and safety within an Agreement State.
An Agreement State’s radiation control
program is adequate to protect public health
and safety if administration of the program
3 For the purposes of this policy statement,
‘‘program element’’ means any component or
function of a radiation control regulatory program,
including regulations and other legally binding
requirements imposed on regulated persons, which
contributes to implementation of that program.
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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 adequate to provide for
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 in some cases can be 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
items i. through v. of this section, that the
NRC and Agreement States will use to define
the scope of the program. The NRC and
Agreement States 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 the protection of public health
and safety.
On the basis of this policy statement, NRC
program elements (including regulations) can
be placed into five compatibility categories
(A, B, C, D, and NRC). In addition, NRC
program elements can also be identified as
having particular health and safety
significance (H&S). These six categories (A,
B, C, D, NRC, and H&S) form the basis for
evaluating and classifying NRC program
elements.
i. Legislation and Legal Authority
Agreement State statutes shall: (a)
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 NRC; (b) authorize the State to
promulgate regulatory requirements
necessary to provide reasonable assurance of
protection of public health and safety; (c)
authorize the State to license, inspect, and
enforce legally binding requirements such as
regulations and licenses; and (d) be otherwise
compatible with applicable Federal statutes.
In addition, the State should have existing
legally enforceable measures such as
generally applicable rules, orders, license
conditions, 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. Specifically, Agreement States
should adopt legally binding requirements
based on those identified by the NRC because
of their particular health and safety
significance. In adopting such requirements,
Agreement States shall implement the
essential objectives articulated in the NRC
requirements.
ii. Licensing
The Agreement State shall conduct
appropriate evaluations of proposed uses of
agreement material, before issuing a license
to authorize such use, to ensure that the
proposed licensee’s need and proposed uses
of agreement material are in accordance with
the AEA and that operations can be
conducted safely. Licenses shall provide for
reasonable assurance of public health and
safety protection in the conduct of licensed
activities.
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iii. Inspection and Enforcement
The Agreement State shall 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
through legal sanctions authorized by State
statutes and regulations.
iv. Personnel
The Agreement State shall be staffed with
a sufficient number of qualified personnel to
implement its regulatory program for the
control of agreement material.
v. Incidents and Allegations
The Agreement State shall 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.
2. Compatibility
A ‘‘compatible’’ program consists of those
program elements necessary to sustain an
orderly pattern of regulation of agreement
material. An Agreement State has the
flexibility to adopt and implement program
elements within the State’s jurisdiction (i.e.,
those items that are not areas of exclusive
NRC regulatory authority) that are not
addressed by the NRC, or program elements
not required for compatibility (i.e., those
NRC program elements not assigned to
Category A, B, or C). However, such program
elements of an Agreement State relating to
agreement material shall (1) be compatible
with those of the NRC (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 a practice authorized by the AEA
and in the national interest; and (3) not
preclude the ability of the NRC to evaluate
the effectiveness of Agreement State
programs for agreement material with respect
to protection of public health and safety. For
purposes of compatibility, the State shall
adopt program elements assigned
Compatibility Categories A, B, and C.
i. Category A—Basic Radiation Protection
Standards
This category includes basic radiation
protection standards that encompass 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 for land disposal of
radioactive waste in 10 CFR 61.41.4 Also
4 The NRC will implement this category
consistent with its earlier decision in the low-level
waste area to allow Agreement States the 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
essentially identical to that afforded by NRC
requirements.
E:\FR\FM\18OCN1.SGM
18OCN1
ethrower on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Notices
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 NRC,
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 considerations such as
economic cost and other factors.
ii. Category B—Cross Jurisdictional Program
Elements
This category pertains to a limited number
of program elements that cross jurisdictional
boundaries and that should be addressed to
ensure uniformity of regulation on a
nationwide basis. Some examples include
sealed source and device registration
certificates, transportation regulations,
radiography certification, access
authorization, and security plan
requirements. Agreement State program
elements shall be essentially identical to
those of the NRC. Because program elements
used in the Agreement State Program are
necessary to maintain an acceptable level of
protection of public health and safety,
economic factors 5 shall not be considered.
iii. Category C—Other NRC Program
Elements
This category includes NRC program
elements that are important for an Agreement
State to implement 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 shall
embody the essential objective of the
corresponding NRC program elements.
Agreement State program elements may be
more restrictive than NRC program elements;
however, they should not be so restrictive as
to prohibit a practice authorized by the AEA
and in the national interest without an
adequate public health and safety or
environmental basis related to radiation
protection.
iv. Category D—Program Elements Not
Required for Compatibility
This category pertains to program elements
that do not meet any of the criteria listed in
Compatibility Category A, B, or C above and
are not required to be adopted for purposes
of compatibility.
v. Category NRC—Areas of Exclusive NRC
Regulatory Authority
This category consists of program elements
over which the NRC cannot discontinue its
regulatory authority pursuant to the AEA or
provisions of 10 CFR. However, an
Agreement State may inform its licensees of
these NRC requirements through an
5 For the purposes of this policy statement,
economic factors are those costs incurred by the
regulated community to comply with regulations
that impact more than one regulatory jurisdiction in
the NMP.
VerDate Sep<11>2014
17:50 Oct 17, 2017
Jkt 244001
appropriate mechanism 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.
F. Conclusion
The NRC and Agreement States will
continue to jointly assess the NRC and
Agreement State programs for the regulation
of agreement material to identify specific
changes that should be considered based on
experience or to further improve overall
safety, performance, compatibility, and
effectiveness.
The NRC encourages Agreement States to
adopt and implement program elements that
are patterned after those adopted and
implemented by the NRC to foster and
enhance an NMP that establishes a coherent
and compatible nationwide program for the
regulation of agreement material.
[FR Doc. 2017–22514 Filed 10–17–17; 8:45 am]
BILLING CODE 7590–01–P
NUCLEAR REGULATORY
COMMISSION
[NRC–2017–0173]
Information Collection: Domestic
Licensing of Production and Utilization
Facilities
Nuclear Regulatory
Commission.
ACTION: Renewal of existing information
collection; request for comment.
AGENCY:
The U.S. Nuclear Regulatory
Commission (NRC) invites public
comment on the renewal of Office of
Management and Budget (OMB)
approval for an existing collection of
information. The information collection
is entitled, ‘‘Domestic Licensing of
Production and Utilization Facilities.’’
DATES: Submit comments by December
18, 2017. Comments received after this
date will be considered if it is practical
to do so, but the Commission is able to
ensure consideration only for comments
received on or before this date.
ADDRESSES: You may submit comments
by any of the following methods:
• Federal Rulemaking Web site: Go to
https://www.regulations.gov and search
for Docket ID NRC–2017–0173. Address
questions about NRC dockets to Carol
Gallagher; telephone: 301–415–3463;
email: Carol.Gallagher@nrc.gov. For
technical questions, contact the
individual listed in the FOR FURTHER
INFORMATION CONTACT section of this
document.
• Mail comments to: David Cullison,
Office of the Chief Information Officer,
Mail Stop: T–2 F43, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555–0001.
SUMMARY:
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
48539
For additional direction on obtaining
information and submitting comments,
see ‘‘Obtaining Information and
Submitting Comments’’ in the
SUPPLEMENTARY INFORMATION section of
this document.
FOR FURTHER INFORMATION CONTACT:
David Cullison, Office of the Chief
Information Officer, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555–0001; telephone: 301–415–
2084; email: INFOCOLLECTS.Resource@
nrc.gov.
SUPPLEMENTARY INFORMATION:
I. Obtaining Information and
Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC–2017–
0173 when contacting the NRC about
the availability of information for this
action. You may obtain publiclyavailable information related to this
action by any of the following methods:
• Federal Rulemaking Web site: Go to
https://www.regulations.gov and search
for Docket ID NRC–2017–0173.
• NRC’s Agencywide Documents
Access and Management System
(ADAMS): You may obtain publiclyavailable documents online in the
ADAMS Public Documents collection 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
seven supporting statements associated
with the part 50 information collections
and the burden table are available in
ADAMS under Accession Nos.
ML17207A259, ML17201K067,
ML17201K126, ML17201K169,
ML17201J977, ML17201K214,
ML17201K024, and ML17283A044,
respectively.
• 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.
• NRC’s Clearance Officer: A copy of
the collection of information and related
instructions may be obtained without
charge by contacting the NRC’s
Clearance Officer, David Cullison,
Office of the Chief Information Officer,
U.S. Nuclear Regulatory Commission,
Washington, DC 20555–0001; telephone:
301–415–2084; email:
INFOCOLLECTS.Resource@nrc.gov.
E:\FR\FM\18OCN1.SGM
18OCN1
Agencies
[Federal Register Volume 82, Number 200 (Wednesday, October 18, 2017)]
[Notices]
[Pages 48535-48539]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22514]
=======================================================================
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
[NRC-2016-0094]
Agreement State Program Policy Statement; Correction
AGENCY: Nuclear Regulatory Commission.
ACTION: Revision to policy statement; correction.
-----------------------------------------------------------------------
SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is correcting a
notice that was published in the Federal Register (FR) on October 6,
2017, regarding consolidation of two policy statements on the NRC's
Agreement State programs. This action is necessary to provide the
policy statement revision which was inadvertently left out of the
previously published FRN.
DATES: The correction is effective October 18, 2017.
ADDRESSES: Please refer to Docket ID NRC-2016-0094 when contacting the
NRC about the availability of information regarding this document. You
may obtain publicly-available information related to this document
using any of the following methods:
Federal Rulemaking Web site: Go to https://www.regulations.gov and search for Docket ID NRC-2016-0094. Address
questions about NRC dockets to Carol Gallagher; telephone: 301-415-
3463; email: Carol.Gallagher@nrc.gov. For technical questions, contact
the individual listed in the FOR FURTHER INFORMATION CONTACT section of
this document.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may obtain publicly-available documents online in the
ADAMS Public Documents collection 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 (if it is available
in ADAMS) is provided the first time that it is mentioned in this
document.
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.
FOR FURTHER INFORMATION CONTACT: Lance Rakovan, Office of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001; telephone: 301-415-2589, email:
Lance.Rakovan@nrc.gov.
SUPPLEMENTARY INFORMATION: In the FR on October 6, 2017, in FR Doc.
2017-21542, please add the Agreement State Program Policy statement.
The text of the Agreement State Program Policy statement is
attached.
Dated at Rockville, Maryland, this 12th day of October 2017.
For the Nuclear Regulatory Commission.
Helen Chang,
Acting Branch Chief, Rules, Announcements and Directives Branch,
Division of Administrative Services, Office of Administration.
Attachment
Agreement State Program Policy Statement
A. Purpose
The purpose of this policy statement for the Agreement State
Program is to describe the respective roles and responsibilities of
the U.S. Nuclear Regulatory Commission (NRC) and Agreement States in
the administration of programs carried out under Section 274 of the
Atomic Energy Act of 1954, as amended (AEA).\1\ Section 274 provides
broad authority for the NRC to establish a unique Federal and State
relationship in the administration of regulatory programs for the
protection of public health and safety in the industrial, medical,
commercial, and research uses of agreement material. This policy
statement supersedes the September 1997 ``Policy Statement on
Adequacy and Compatibility of Agreement State Programs'' and
``Statement of Principles and Policy for the Agreement State
Program.''
---------------------------------------------------------------------------
\1\ Subsection 274b. of the AEA authorizes the NRC to enter into
an agreement by which the NRC discontinues and the State assumes
regulatory authority over some or all of these materials. The
material over which the State receives regulatory authority under
such agreement is termed ``agreement material.''
---------------------------------------------------------------------------
This policy statement addresses the Federal-State interaction
under the AEA to (1) establish and maintain agreements with States
under Subsection 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 use of agreement
material; (2) ensure that post-agreement interactions between the
NRC and Agreement State radiation control programs are coordinated;
and (3) ensure Agreement States provide adequate protection of
public health and safety and maintain programs that are compatible
with the NRC's regulatory program.
Although not defined in the AEA, the National Materials Program
(NMP) is a term used to describe the broad collective effort within
which both the NRC and the Agreement States function in carrying out
their respective regulatory programs for agreement material. The
vision of the NMP is to provide a coherent national system for the
regulation of agreement material with the goal of protecting public
health and safety through compatible regulatory programs. Through
the NMP, the NRC and Agreement States function as regulatory
partners.
B. Background
This policy statement is intended solely as guidance for the NRC
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
[[Page 48536]]
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 pursuant to this policy statement shall be
consistent with the legal authorities of the NRC and the Agreement
States.
This policy statement presents the NRC's policy for determining
the adequacy and compatibility of Agreement State programs. This
policy statement clarifies the meaning and use of the terms
``adequate to protect public health and safety'' and ``compatible
with the NRC's regulatory program'' as applied to Agreement State
programs. The terms ``adequate'' and ``compatible'' represent
fundamental concepts in the Agreement State programs authorized in
1959 by Section 274 of the AEA. Subsection 274d. states that the NRC
shall enter into an Agreement under Subsection 274b. that
discontinues the NRC's regulatory authority over specified AEA
radioactive materials and activities within a State, provided that
the State's program is adequate to protect public health and safety
and is compatible with the NRC's regulatory program. Subsection
274g. authorizes and directs the NRC to cooperate with States in the
formulation of standards to assure that State and NRC programs for
protection against hazards of radiation will be coordinated and
compatible. Subsection 274j.(1) requires the NRC to periodically
review the Agreements and actions taken by States under the
Agreements to ensure compliance with the provisions of Section 274.
The NRC and Agreement State radiation control programs maintain
regulatory authority for the safe and secure handling, use, and
storage of agreement material. These programs have always included
the security of agreement material as an integral part of their
health and safety mission as it relates to controlling and
minimizing the risk of exposure to workers and the public. Following
the events of September 11, 2001, the NRC and Agreement States
developed and implemented enhanced security measures. For the
purposes of this policy statement, public health and safety includes
the physical protection of agreement material.
C. Statement of Legislative Intent
In 1954, the AEA did not initially specify a role for the States
in regulating the use of nuclear material. Many States were
concerned as to what their responsibilities in this area might be
and expressed interest in clearly defining the boundaries of Federal
and State authority over nuclear material. 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
AEA radioactive materials--defined as byproduct, source, and special
nuclear material--the States maintained the responsibility for
protecting the public from the radiation hazards of other sources
such as x-ray machines and naturally occurring radioactive material.
Consequently, in 1959, Congress enacted Section 274 of the AEA
to establish a statutory framework under which States could assume,
and the NRC could discontinue, regulatory authority over byproduct,
source, and small quantities of special nuclear material
insufficient to form a critical mass. The NRC continued to retain
regulatory authority over the licensing of certain facilities and
activities, including nuclear reactors, quantities of special
nuclear material sufficient to form a critical mass, the export and
import of nuclear materials, and matters related to common defense
and security.
The legislation did not authorize a wholesale, immediate
relinquishment or abdication by the Commission \2\ of its regulatory
responsibilities but only a gradual, carefully considered turnover.
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 NRC to provide training,
with or without charge, and other services to State officials and
employees as the Commission deems appropriate. However, in rendering
this assistance, Congress did not intend that the NRC 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 under their Agreement and to permit the
NRC to discontinue its regulatory responsibilities in those areas.
---------------------------------------------------------------------------
\2\ For the purposes of this policy statement, ``Commission''
means the five member Commission or a quorum thereof sitting as a
body, as provided by Section 201 of the Energy Reorganization Act of
1974 (42 U.S.C. 5841).
---------------------------------------------------------------------------
In order to discontinue its authority, the NRC must find that
the State program is adequate to protect public health and safety
and compatible with the NRC program for the regulation of agreement
material. In addition, the NRC has an obligation, pursuant to
Subsection 274j. of the AEA, to periodically review existing
Agreement State programs to ensure continued adequacy and
compatibility. Subsection 274j. of the AEA provides that the NRC may
terminate or suspend all or part of its agreement with a State if
the NRC finds that such termination is necessary to protect public
health and safety or that the State has not complied with the
provisions of Subsection 274j. In these cases, the NRC must offer
the State reasonable notice and opportunity for a hearing. In cases
where the State has requested termination of the agreement, notice
and opportunity for a hearing are not necessary. In addition, the
NRC may temporarily suspend all or part of an agreement in the case
of an emergency situation.
D. Program Implementation
1. Implementation of the Agreement State Program is described
below and includes (a) Principles of Good Regulation; (b)
performance evaluation on a consistent and systematic basis; (c) the
responsibility to ensure adequate protection of public health and
safety, including physical protection of agreement material; (d)
compatibility in areas of national interest; and (e) sufficient
flexibility in program implementation and administration to
accommodate individual State needs.
i. Principles of Good Regulation
In 1991, the Commission adopted the ``Principles of Good
Regulation'' to serve as a guide to both agency decision making and
the individual behavior of 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 and
are 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. Such principles are useful as a part
of a common culture of the NMP that the NRC and the Agreement States
share as co-regulators. Accordingly, the NRC encourages each
Agreement State to adopt a similar set of principles for use in its
own regulatory program. These principles should be incorporated into
the day-to-day operational fabric of the NMP.
ii. Performance Evaluation
To ensure that Agreement State programs continue to provide
adequate protection of public health and safety and are compatible
with the NRC's regulatory program, periodic program evaluation is
needed. The NRC, 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 and integrated evaluations of the strengths and
weaknesses of their respective radiation control programs and
identification of areas needing improvement.
iii. 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, including
physical protection of agreement material. 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.
iv. Compatible in Areas of National Interest
The NRC and the Agreement States have the responsibility to
ensure that the radiation control programs are compatible. Such
radiation control programs should be based on a common regulatory
philosophy including the common use of definitions and standards.
The programs should be effective
[[Page 48537]]
and cooperatively implemented by the NRC and the Agreement States
and also should provide uniformity and achieve common strategic
outcomes in program areas of national significance.
Such areas include aspects of licensing, inspection and
enforcement, response to incidents and allegations, and safety
reviews for the manufacture and distribution of sealed sources and
devices. Furthermore, communication using a nationally accepted set
of terms with common understanding, ensuring an adequate level of
protection of public health and safety that is consistent and stable
across the nation, and evaluation of the effectiveness of the NRC
and Agreement State programs for the regulation of agreement
material with respect to protection of public health and safety are
essential to maintaining the NMP.
v. Flexibility
With the exception of those compatibility areas where programs
should be essentially identical, Agreement State radiation control
programs have flexibility in program implementation and
administration to accommodate individual State preferences, State
legislative direction, and local needs and conditions. A State has
the flexibility to design its own program, including incorporating
more stringent, or similar, requirements provided that the
requirements for adequate protection of public health and safety are
met and compatibility is maintained. However, the exercise of such
flexibility should not preclude a practice authorized by the AEA,
and in the national interest.
2. 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 that would be covered by
the proposed agreement. This certification will be provided in a
letter to the NRC that includes supporting documentation. This
documentation includes the State's enabling legislation; the
radiation control regulations; the radiation control program
staffing plan; a narrative description of the State program's
policies, practices, and procedures; and a proposed agreement.
The NRC's policy statement, ``Criteria for Guidance of States
and NRC in Discontinuance of NRC Regulatory Authority and Assumption
Thereof by States Through Agreement'' (46 FR 7540, January 23, 1981;
as amended by policy statements published at 46 FR 36969, July 16,
1981; and 48 FR 33376, July 21, 1983), describes the required
content of these documents. 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 NRC determines that the proposed State
program is adequate for protection of public health and safety and
compatible with the NRC's regulatory program, the Governor and
Chairman of the NRC sign the agreement.
3. 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 their request for entering into an
Agreement and to help them prior to the assumption of regulatory
authority. Following approval of the agreement and assumption of
regulatory authority by a new Agreement State, to the extent
permitted by resources, the NRC may provide training and offer other
assistance (such as review of proposed regulatory changes to help
Agreement States administer their regulatory responsibilities).
Nevertheless, it is the responsibility of each Agreement State to
ensure that it has a sufficient number of qualified staff to
implement its program. If the NRC is unable to provide the training,
the Agreement State will need to do so.
The NRC may also use its best efforts to provide specialized
technical assistance to Agreement States to address unique or
complex licensing, inspection, incident response, 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.
If an Agreement State experiences difficulty in implementing its
program, the NRC will, to the extent possible, assist the State in
maintaining the effectiveness of its radiation control program.
Under certain conditions, an Agreement State can also voluntarily
return all or part of its Agreement State program.
4. Performance Evaluation
Under Section 274 of the AEA, the NRC retains oversight
authority for ensuring that Agreement State programs provide
adequate protection of public health and safety and are compatible
with the NRC's regulatory program. In fulfilling this statutory
responsibility, the NRC will determine whether the Agreement State
programs are adequate and compatible prior to entrance into a
Subsection 274b. agreement and will periodically review the program
to ensure it continues to be adequate and compatible after an
agreement becomes effective.
To fulfill this responsibility, the NRC, in cooperation with the
Agreement States, established and implemented the IMPEP. As
described in Management Directive 5.6 ``Integrated Materials
Performance Evaluation Program (IMPEP),'' IMPEP is a performance
evaluation process that provides the NRC and Agreement States with
systematic, integrated, and reliable evaluations of the strengths
and weaknesses of their respective radiation control programs and
identification of areas needing improvement. The same criteria 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), comprised of senior NRC staff members
to make a determination of program adequacy and compatibility. An
MRB also includes an Agreement State liaison, provided by the
Organization of Agreement States (OAS), as a non-voting member.
As a part of the performance evaluation process, the NRC will
take 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
providing assistance to help address weaknesses or areas needing
improvement within an Agreement State program. Monitoring,
heightened oversight, probation, suspension, or termination of an
agreement may be applied for certain program deficiencies or
emergencies (e.g. loss of funding, natural or man-made events,
pandemic). The NRC's actions in addressing program deficiencies or
emergencies will be implemented through a well-defined process that
is consistently and fairly applied.
5. Program Funding and Training
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. Section 274 of the AEA does not allow
Federal funding for the administration of Agreement State radiation
control programs. Given the importance to 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. These training programs also
help to ensure compatible approaches to licensing and inspection and
thereby strengthen the NMP.
6. 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 and guidance documents 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, orders, 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. 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, Agreement States should inform the NRC of, and
provide the opportunity to review and comment on, proposed changes
in regulations and significant changes to Agreement State programs,
policies, and regulatory guidance.
Two national organizations composed of State radiation control
program personnel facilitate participation and involvement with the
development of regulations, guidance, and policy. The OAS provides a
forum for Agreement States to work with each other and with the NRC
on regulatory issues, including centralized communication on
radiation protection matters between the Agreement States and the
NRC. The
[[Page 48538]]
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.
One product of the CRCPD is the Suggested State Regulations for use
by its members. The NRC reviews Suggested State Regulations for
compatibility.
E. Adequacy and Compatibility
In accordance with Section 274 of the AEA, any State that
chooses to establish an Agreement State program must provide for an
acceptable level of protection of public health and safety. This is
the ``adequacy'' component. The Agreement State must also ensure
that its program supports an overall nationwide program in radiation
protection. This is the ``compatibility'' component.
By adopting the criteria for adequacy and compatibility as
discussed in this policy statement, the NRC provides a broad range
of flexibility in the administration of individual Agreement State
programs. Recognizing the fact that Agreement States have
responsibilities for radiation sources other than agreement
material, the NRC allows Agreement States to fashion their programs
to reflect specific State needs and preferences.
The NRC will minimize the number of NRC regulatory requirements
that the Agreement States will be requested to adopt in an identical
manner to maintain compatibility. At the same time, requirements in
these compatibility categories allow the NRC to ensure that an
orderly pattern for the regulation of agreement material exists
nationwide. The NRC believes that this approach achieves a proper
balance between the need for Agreement State flexibility and the
need for an NMP that is coherent and compatible in the regulation of
agreement material across the country.
Program elements \3\ for adequacy focus on the protection of
public health and safety within a particular Agreement 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. Some program
elements for compatibility may also impact public health and safety;
therefore, they may also be considered program elements for
adequacy.
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\3\ For the purposes of this policy statement, ``program
element'' means any component or function of a radiation control
regulatory program, including regulations and other legally binding
requirements imposed on regulated persons, which contributes to
implementation of that program.
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In identifying those program elements for adequate and
compatible programs, or any changes thereto, the NRC staff will
coordinate with the Agreement States.
1. Adequacy
An ``adequate'' program includes those program elements of a
radiation control regulatory program necessary to maintain an
acceptable level of protection of public health and safety within an
Agreement State. 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 adequate to provide
for 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 in
some cases can be 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 items i. through v.
of this section, that the NRC and Agreement States will use to
define the scope of the program. The NRC and Agreement States 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 the protection of public health and
safety.
On the basis of this policy statement, NRC program elements
(including regulations) can be placed into five compatibility
categories (A, B, C, D, and NRC). In addition, NRC program elements
can also be identified as having particular health and safety
significance (H&S). These six categories (A, B, C, D, NRC, and H&S)
form the basis for evaluating and classifying NRC program elements.
i. Legislation and Legal Authority
Agreement State statutes shall: (a) 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 NRC; (b) authorize the State to
promulgate regulatory requirements necessary to provide reasonable
assurance of protection of public health and safety; (c) authorize
the State to license, inspect, and enforce legally binding
requirements such as regulations and licenses; and (d) be otherwise
compatible with applicable Federal statutes. In addition, the State
should have existing legally enforceable measures such as generally
applicable rules, orders, license conditions, 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. Specifically, Agreement States should adopt legally
binding requirements based on those identified by the NRC because of
their particular health and safety significance. In adopting such
requirements, Agreement States shall implement the essential
objectives articulated in the NRC requirements.
ii. Licensing
The Agreement State shall conduct appropriate evaluations of
proposed uses of agreement material, before issuing a license to
authorize such use, to ensure that the proposed licensee's need and
proposed uses of agreement material are in accordance with the AEA
and that operations can be conducted safely. Licenses shall provide
for reasonable assurance of public health and safety protection in
the conduct of licensed activities.
iii. Inspection and Enforcement
The Agreement State shall 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 through legal sanctions authorized by State statutes and
regulations.
iv. Personnel
The Agreement State shall be staffed with a sufficient number of
qualified personnel to implement its regulatory program for the
control of agreement material.
v. Incidents and Allegations
The Agreement State shall 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.
2. Compatibility
A ``compatible'' program consists of those program elements
necessary to sustain an orderly pattern of regulation of agreement
material. An Agreement State has the flexibility to adopt and
implement program elements within the State's jurisdiction (i.e.,
those items that are not areas of exclusive NRC regulatory
authority) that are not addressed by the NRC, or program elements
not required for compatibility (i.e., those NRC program elements not
assigned to Category A, B, or C). However, such program elements of
an Agreement State relating to agreement material shall (1) be
compatible with those of the NRC (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 a practice authorized by the AEA
and in the national interest; and (3) not preclude the ability of
the NRC to evaluate the effectiveness of Agreement State programs
for agreement material with respect to protection of public health
and safety. For purposes of compatibility, the State shall adopt
program elements assigned Compatibility Categories A, B, and C.
i. Category A--Basic Radiation Protection Standards
This category includes basic radiation protection standards that
encompass 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 for land disposal of radioactive waste in 10 CFR 61.41.\4\
Also
[[Page 48539]]
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 NRC, 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 considerations such as economic cost and
other factors.
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\4\ The NRC will implement this category consistent with its
earlier decision in the low-level waste area to allow Agreement
States the 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 essentially identical to that afforded by NRC
requirements.
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ii. Category B--Cross Jurisdictional Program Elements
This category pertains to a limited number of program elements
that cross jurisdictional boundaries and that should be addressed to
ensure uniformity of regulation on a nationwide basis. Some examples
include sealed source and device registration certificates,
transportation regulations, radiography certification, access
authorization, and security plan requirements. Agreement State
program elements shall be essentially identical to those of the NRC.
Because program elements used in the Agreement State Program are
necessary to maintain an acceptable level of protection of public
health and safety, economic factors \5\ shall not be considered.
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\5\ For the purposes of this policy statement, economic factors
are those costs incurred by the regulated community to comply with
regulations that impact more than one regulatory jurisdiction in the
NMP.
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iii. Category C--Other NRC Program Elements
This category includes NRC program elements that are important
for an Agreement State to implement 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 shall embody
the essential objective of the corresponding NRC program elements.
Agreement State program elements may be more restrictive than NRC
program elements; however, they should not be so restrictive as to
prohibit a practice authorized by the AEA and in the national
interest without an adequate public health and safety or
environmental basis related to radiation protection.
iv. Category D--Program Elements Not Required for Compatibility
This category pertains to program elements that do not meet any
of the criteria listed in Compatibility Category A, B, or C above
and are not required to be adopted for purposes of compatibility.
v. Category NRC--Areas of Exclusive NRC Regulatory Authority
This category consists of program elements over which the NRC
cannot discontinue its regulatory authority pursuant to the AEA or
provisions of 10 CFR. However, an Agreement State may inform its
licensees of these NRC requirements through an appropriate mechanism
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.
F. Conclusion
The NRC and Agreement States will continue to jointly assess the
NRC and Agreement State programs for the regulation of agreement
material to identify specific changes that should be considered
based on experience or to further improve overall safety,
performance, compatibility, and effectiveness.
The NRC encourages Agreement States to adopt and implement
program elements that are patterned after those adopted and
implemented by the NRC to foster and enhance an NMP that establishes
a coherent and compatible nationwide program for the regulation of
agreement material.
[FR Doc. 2017-22514 Filed 10-17-17; 8:45 am]
BILLING CODE 7590-01-P