82 FR 48535 - Agreement State Program Policy Statement; Correction

NUCLEAR REGULATORY COMMISSION

Federal Register Volume 82, Issue 200 (October 18, 2017)

Page Range		48535-48539
FR Document		2017-22514
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.
Federal Register, Volume 82 Issue 200 (Wednesday, October 18, 2017)
[Federal Register Volume 82, Number 200 (Wednesday, October 18, 2017)]
[Notices]
[Pages 48535-48539]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-22514]


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NUCLEAR REGULATORY COMMISSION

[NRC-2016-0094]


Agreement State Program Policy Statement; Correction

AGENCY: Nuclear Regulatory Commission.

ACTION: Revision to policy statement; correction.

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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 http://www.regulations.gov and search for Docket ID NRC-2016-0094. Address 
questions about NRC dockets to Carol Gallagher; telephone: 301-415-
3463; email: [email protected]. 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 http://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 [email protected]. 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: 
[email protected].

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.''
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    \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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    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.
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    \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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    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]
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Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Notices 48537

and cooperatively implemented by the NRC 3. Program Assistance and compatibility. An MRB also includes an
and the Agreement States and also should The NRC will offer training and other Agreement State liaison, provided by the
provide uniformity and achieve common assistance to States, such as assistance in Organization of Agreement States (OAS), as
strategic outcomes in program areas of developing regulations and program a non-voting member.
national significance. descriptions to help individual States As a part of the performance evaluation
Such areas include aspects of licensing, prepare their request for entering into an process, the NRC will take necessary actions
inspection and enforcement, response to Agreement and to help them prior to the to help ensure that Agreement State radiation
incidents and allegations, and safety reviews assumption of regulatory authority. control programs remain adequate and
for the manufacture and distribution of Following approval of the agreement and compatible. These actions may include more
sealed sources and devices. Furthermore, assumption of regulatory authority by a new frequent IMPEP reviews of Agreement State
communication using a nationally accepted Agreement State, to the extent permitted by programs and providing assistance to help
set of terms with common understanding, address weaknesses or areas needing
resources, the NRC may provide training and
ensuring an adequate level of protection of improvement within an Agreement State
offer other assistance (such as review of
public health and safety that is consistent program. Monitoring, heightened oversight,
proposed regulatory changes to help
and stable across the nation, and evaluation probation, suspension, or termination of an
Agreement States administer their regulatory
of the effectiveness of the NRC and agreement may be applied for certain
responsibilities). Nevertheless, it is the
Agreement State programs for the regulation program deficiencies or emergencies (e.g. loss
responsibility of each Agreement State to
of agreement material with respect to of funding, natural or man-made events,
ensure that it has a sufficient number of
protection of public health and safety are pandemic). The NRC’s actions in addressing
qualified staff to implement its program. If
essential to maintaining the NMP. program deficiencies or emergencies will be
the NRC is unable to provide the training, the
v. Flexibility Agreement State will need to do so. implemented through a well-defined process
The NRC may also use its best efforts to that is consistently and fairly applied.
With the exception of those compatibility
areas where programs should be essentially provide specialized technical assistance to 5. Program Funding and Training
identical, Agreement State radiation control Agreement States to address unique or Section 274 of the AEA permits the NRC
programs have flexibility in program complex licensing, inspection, incident to offer training and other assistance to a
implementation and administration to response, and limited enforcement issues. In State in anticipation of entering into an
accommodate individual State preferences, areas where Agreement States have particular Agreement with the NRC. Section 274 of the
State legislative direction, and local needs expertise or are in the best position to AEA does not allow Federal funding for the
and conditions. A State has the flexibility to provide immediate assistance to the NRC or administration of Agreement State radiation
design its own program, including other Agreement States, they are encouraged control programs. Given the importance to
incorporating more stringent, or similar, to do so. In addition, the NRC and Agreement public health and safety of having well
requirements provided that the requirements States will keep each other informed about trained radiation control program personnel,
for adequate protection of public health and relevant aspects of their programs. the NRC may offer certain relevant training
safety are met and compatibility is If an Agreement State experiences courses and notify Agreement State
maintained. However, the exercise of such difficulty in implementing its program, the personnel of their availability. These training
flexibility should not preclude a practice NRC will, to the extent possible, assist the programs also help to ensure compatible
authorized by the AEA, and in the national State in maintaining the effectiveness of its approaches to licensing and inspection and
interest. radiation control program. Under certain thereby strengthen the NMP.
2. New Agreements conditions, an Agreement State can also
6. Regulatory Development
Section 274 of the AEA requires that once voluntarily return all or part of its Agreement
State program. The NRC and Agreement States will
a decision to request Agreement State status cooperate in the development of both new
is made by the State, the Governor of that 4. Performance Evaluation and revised regulations and policies.
State must certify to the NRC that the State Under Section 274 of the AEA, the NRC Agreement States will have early and
desires to assume regulatory responsibility retains oversight authority for ensuring that substantive involvement in the development
and has a program for the control of radiation Agreement State programs provide adequate of regulations affecting protection of public
hazards adequate to protect public health and protection of public health and safety and are health and safety and of policies and
safety with respect to the materials within
compatible with the NRC’s regulatory guidance documents affecting administration
the State that would be covered by the
program. In fulfilling this statutory of the Agreement State program. The NRC
proposed agreement. This certification will
responsibility, the NRC will determine and Agreement States will keep each other
be provided in a letter to the NRC that
whether the Agreement State programs are informed about their individual regulatory
includes supporting documentation. This
adequate and compatible prior to entrance requirements (e.g., regulations, orders, or
documentation includes the State’s enabling
legislation; the radiation control regulations; into a Subsection 274b. agreement and will license conditions) and the effectiveness of
the radiation control program staffing plan; a periodically review the program to ensure it those regulatory requirements so that each
narrative description of the State program’s continues to be adequate and compatible has the opportunity to make use of proven
policies, practices, and procedures; and a after an agreement becomes effective. regulatory approaches to further the effective
proposed agreement. To fulfill this responsibility, the NRC, in and efficient use of resources. In order to
The NRC’s policy statement, ‘‘Criteria for cooperation with the Agreement States, avoid conflicts, duplications, gaps, or other
Guidance of States and NRC in established and implemented the IMPEP. As conditions that would jeopardize an orderly
Discontinuance of NRC Regulatory Authority described in Management Directive 5.6 pattern in the regulation of agreement
and Assumption Thereof by States Through ‘‘Integrated Materials Performance Evaluation material on a nationwide basis, Agreement
Agreement’’ (46 FR 7540, January 23, 1981; Program (IMPEP),’’ IMPEP is a performance States should inform the NRC of, and provide
as amended by policy statements published evaluation process that provides the NRC and the opportunity to review and comment on,
at 46 FR 36969, July 16, 1981; and 48 FR Agreement States with systematic, integrated, proposed changes in regulations and
33376, July 21, 1983), describes the required and reliable evaluations of the strengths and significant changes to Agreement State
content of these documents. The NRC weaknesses of their respective radiation programs, policies, and regulatory guidance.
reviews the request and publishes notice of control programs and identification of areas Two national organizations composed of
the proposed agreement in the Federal needing improvement. The same criteria are State radiation control program personnel
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Register to provide an opportunity for public used to evaluate and ensure that regulatory facilitate participation and involvement with
comment. After consideration of public programs are adequate to protect public the development of regulations, guidance,
comments, if the NRC determines that the health and safety and that Agreement State and policy. The OAS provides a forum for
proposed State program is adequate for programs are compatible with the NRC’s Agreement States to work with each other
protection of public health and safety and program. The IMPEP process employs a and with the NRC on regulatory issues,
compatible with the NRC’s regulatory Management Review Board (MRB), including centralized communication on
program, the Governor and Chairman of the comprised of senior NRC staff members to radiation protection matters between the
NRC sign the agreement. make a determination of program adequacy Agreement States and the NRC. The

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48538 Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Notices

Conference of Radiation Control Program provides reasonable assurance of protection iii. Inspection and Enforcement
Directors, Inc. (CRCPD) assists its members in of public health and safety in regulating the The Agreement State shall periodically
their efforts to protect the public, radiation use of agreement material. The level of conduct inspections of licensed activities
workers, and patients from unnecessary protection afforded by the program elements involving agreement material to provide
radiation exposure. One product of the of the NRC’s materials regulatory program is reasonable assurance of safe licensee
CRCPD is the Suggested State Regulations for presumed to be adequate to provide for operations and to determine compliance with
use by its members. The NRC reviews reasonable assurance of protection of public its regulatory requirements. When
Suggested State Regulations for health and safety. Therefore, the overall level determined to be necessary by the State, the
compatibility. of protection of public health and safety State should take timely enforcement action
provided by a State program should be through legal sanctions authorized by State
E. Adequacy and Compatibility equivalent to, or in some cases can be greater statutes and regulations.
In accordance with Section 274 of the than, the level provided by the NRC program.
AEA, any State that chooses to establish an To provide reasonable assurance of iv. Personnel
Agreement State program must provide for an protection of public health and safety, an The Agreement State shall be staffed with
acceptable level of protection of public Agreement State program should contain the a sufficient number of qualified personnel to
health and safety. This is the ‘‘adequacy’’ five essential program elements, identified in implement its regulatory program for the
component. The Agreement State must also items i. through v. of this section, that the control of agreement material.
ensure that its program supports an overall NRC and Agreement States will use to define
v. Incidents and Allegations
nationwide program in radiation protection. the scope of the program. The NRC and
This is the ‘‘compatibility’’ component. Agreement States will also consider, when The Agreement State shall respond to and
By adopting the criteria for adequacy and appropriate, other program elements of an conduct timely inspections or investigations
compatibility as discussed in this policy Agreement State that appear to affect the of incidents, reported events, and allegations
statement, the NRC provides a broad range of program’s ability to provide reasonable involving agreement material within the
flexibility in the administration of individual assurance of the protection of public health State’s jurisdiction to provide reasonable
Agreement State programs. Recognizing the and safety. assurance of protection of public health and
fact that Agreement States have On the basis of this policy statement, NRC safety.
responsibilities for radiation sources other program elements (including regulations) can 2. Compatibility
than agreement material, the NRC allows be placed into five compatibility categories
(A, B, C, D, and NRC). In addition, NRC A ‘‘compatible’’ program consists of those
Agreement States to fashion their programs to
program elements can also be identified as program elements necessary to sustain an
reflect specific State needs and preferences.
having particular health and safety orderly pattern of regulation of agreement
The NRC will minimize the number of
significance (H&S). These six categories (A, material. An Agreement State has the
NRC regulatory requirements that the
B, C, D, NRC, and H&S) form the basis for flexibility to adopt and implement program
Agreement States will be requested to adopt
evaluating and classifying NRC program elements within the State’s jurisdiction (i.e.,
in an identical manner to maintain
elements. those items that are not areas of exclusive
compatibility. At the same time,
NRC regulatory authority) that are not
requirements in these compatibility i. Legislation and Legal Authority addressed by the NRC, or program elements
categories allow the NRC to ensure that an Agreement State statutes shall: (a) not required for compatibility (i.e., those
orderly pattern for the regulation of Authorize the State to establish a program for NRC program elements not assigned to
agreement material exists nationwide. The the regulation of agreement material and Category A, B, or C). However, such program
NRC believes that this approach achieves a provide authority for the assumption of elements of an Agreement State relating to
proper balance between the need for regulatory responsibility under an Agreement agreement material shall (1) be compatible
Agreement State flexibility and the need for with the NRC; (b) authorize the State to with those of the NRC (i.e., should not create
an NMP that is coherent and compatible in promulgate regulatory requirements conflicts, duplications, gaps, or other
the regulation of agreement material across necessary to provide reasonable assurance of conditions that would jeopardize an orderly
the country. protection of public health and safety; (c) pattern in the regulation of agreement
Program elements 3 for adequacy focus on authorize the State to license, inspect, and material on a nationwide basis); (2) not
the protection of public health and safety enforce legally binding requirements such as preclude a practice authorized by the AEA
within a particular Agreement State, while regulations and licenses; and (d) be otherwise and in the national interest; and (3) not
program elements for compatibility focus on compatible with applicable Federal statutes. preclude the ability of the NRC to evaluate
the impacts of an Agreement State’s In addition, the State should have existing the effectiveness of Agreement State
regulation of agreement material on a legally enforceable measures such as programs for agreement material with respect
nationwide basis or its potential effects on generally applicable rules, orders, license to protection of public health and safety. For
other jurisdictions. Some program elements conditions, or other appropriate measures, purposes of compatibility, the State shall
for compatibility may also impact public necessary to allow the State to ensure adopt program elements assigned
health and safety; therefore, they may also be adequate protection of public health and
Compatibility Categories A, B, and C.
considered program elements for adequacy. safety in the regulation of agreement material
In identifying those program elements for in the State. Specifically, Agreement States i. Category A—Basic Radiation Protection
adequate and compatible programs, or any should adopt legally binding requirements Standards
changes thereto, the NRC staff will based on those identified by the NRC because This category includes basic radiation
coordinate with the Agreement States. of their particular health and safety protection standards that encompass dose
significance. In adopting such requirements, limits, concentration, and release limits
1. Adequacy
Agreement States shall implement the related to radiation protection in Part 20 of
An ‘‘adequate’’ program includes those essential objectives articulated in the NRC Title 10 of the Code of Federal Regulations
program elements of a radiation control requirements. (10 CFR), that are generally applicable, and
regulatory program necessary to maintain an ii. Licensing the dose limits for land disposal of
acceptable level of protection of public radioactive waste in 10 CFR 61.41.4 Also
health and safety within an Agreement State. The Agreement State shall conduct
An Agreement State’s radiation control appropriate evaluations of proposed uses of
4 The NRC will implement this category
program is adequate to protect public health agreement material, before issuing a license
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to authorize such use, to ensure that the consistent with its earlier decision in the low-level
and safety if administration of the program waste area to allow Agreement States the flexibility
proposed licensee’s need and proposed uses
to establish pre-closure operational release limit
3 For the purposes of this policy statement,
of agreement material are in accordance with
objectives, as low as is reasonably achievable goals,
‘‘program element’’ means any component or
the AEA and that operations can be or design objectives at such levels as the State may
function of a radiation control regulatory program, conducted safely. Licenses shall provide for deem necessary or appropriate, as long as the level
including regulations and other legally binding reasonable assurance of public health and of protection of public health and safety is
requirements imposed on regulated persons, which safety protection in the conduct of licensed essentially identical to that afforded by NRC
contributes to implementation of that program. activities. requirements.

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Document Created: 2017-10-18 01:37:55
Document Modified: 2017-10-18 01:37:55
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Revision to policy statement; correction.
Dates		The correction is effective October 18, 2017.
Contact		Lance Rakovan, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2589, email: [email protected]
FR Citation		82 FR 48535