[Federal Register Volume 81, Number 106 (Thursday, June 2, 2016)]
[Notices]
[Pages 35388-35395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13006]


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NUCLEAR REGULATORY COMMISSION

[NRC-2016-0094]


Policy Statement for the Agreement State Program

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed policy statement; request for comment.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has revised and 
consolidated two policy statements on NRC's Agreement State Programs: 
the ``Policy Statement on Adequacy and Compatibility of Agreement State 
Programs'' and the ``Statement of Principles and Policy for the 
Agreement State Program.'' The resulting proposed single policy 
statement has been revised to add that public health and safety 
includes physical protection of agreement material.\1\
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    \1\ The term `agreement material' means the materials listed in 
Subsection 274b. of the Atomic Energy Act of 1954, as amended (AEA), 
over which the States may receive regulatory authority.

DATES: Submit comments by August 16, 2016. Comments received after this 
date will be considered if it is practical to do so, but the NRC is 
able to assure consideration only for comments received on or before 
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this date.

ADDRESSES: You may submit comments by any of the following methods 
(unless this document describes a different method for submitting 
comments on a specific subject):
     Federal Rulemaking Web site: Go to 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.
     Mail comments to: Cindy Bladey, Office of Administration, 
Mail Stop: OWFN 12-H08, U.S. Nuclear Regulatory Commission, Washington, 
DC 20555-0001.
    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: Lisa Dimmick, Office of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001; telephone: 301-415-0694, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Obtaining Information and Submitting Comments
II. Background
III. Discussion of Proposed Changes
IV. Proposed Policy Statement for the Agreement State Program

I. Obtaining Information and Submitting Comments

A. Obtaining Information

    Please refer to Docket ID NRC-2016-0094 when contacting the NRC 
about the availability of information for this action. You may obtain 
publicly-available information related to this action by any of the 
following methods:
     Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2016-0094.
     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 publicly 
available in ADAMS) is provided the first time that it is mentioned in 
the SUPPLEMENTARY INFORMATION section.
     NRC's PDR: You may examine and purchase copies of public 
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 
Rockville Pike, Rockville, Maryland 20852.

B. Submitting Comments

    Please include Docket ID NRC-2016-0094 in your comment submission.
    The NRC cautions you not to include identifying or contact 
information that you do not want to be publicly disclosed in your 
comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into 
ADAMS. The NRC does not routinely edit comment submissions to remove 
identifying or contact information.
    If you are requesting or aggregating comments from other persons 
for submission to the NRC, then you should inform those persons not to 
include identifying or contact information that they do not want to be 
publicly disclosed in their comment submission. Your request should 
state that the NRC does not routinely edit comment submissions to 
remove such information before making the comment submissions available 
to the public or entering the comment into ADAMS.

II. Background

    The ``Adequacy and Compatibility of Agreement State Programs'' (62 
FR 46517; September 3, 1997) presents the NRC's policy for determining 
the adequacy and compatibility of Agreement State programs. The 
``Statement of Principles and Policy for the Agreement State Program'' 
(62 FR 46517; September 3, 1997) describes the respective roles and 
responsibilities of the NRC and the States in the administration of 
programs carried out under the 274b. State Agreement.\2\ The

[[Page 35389]]

application of these two policy statements has significant influence on 
the safety and security of agreement material and on regulation of the 
more than 22,000 Agreement State and NRC materials licensees.
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    \2\ Section 274 of the AEA provides a statutory basis under 
which the NRC discontinues portions of its regulatory authority to 
license and regulate byproduct materials; source materials; and 
quantities of special nuclear materials under critical mass. The 
mechanism for the transfer of NRC's authority to a State is an 
agreement signed by the Governor of the State and the Chairman of 
the Commission, in accordance with Subsection 274b. of the AEA.
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    In the 1990s, the ``Policy Statement on Adequacy and Compatibility 
of Agreement State Programs'' and the ``Statement of Principles and 
Policy for the Agreement State Program'' were developed by working 
groups consisting of Agreement States representatives and the NRC 
staff. A number of workshops and meetings were also held to gather 
stakeholder input. The Commission approved both policy statements in 
the Staff Requirements Memorandum (SRM) to SECY-95-112, ``Final Policy 
Statement on Adequacy and Compatibility of Agreement State Programs,'' 
and SECY-95-115, ``Final `Statement of Principles and Policy for 
Agreement State Program' and `Procedures for Suspension and Termination 
of an Agreement State Program','' dated June 29, 1995 (ADAMS Accession 
No. ML003759325), but deferred implementation until all implementing 
procedures were completed and approved by the Commission. In the June 
30, 1997, SRM to SECY-97-054, ``Final Recommendations on Policy 
Statements and Implementing Procedures for: `Statement of Principles 
and Policy for the Agreement State Program' and `Policy Statement on 
Adequacy and Compatibility of Agreement State Programs','' the 
Commission approved the accompanying implementing procedures for the 
policy statements (ADAMS Accession No. ML051610710). The policy 
statements became effective on September 3, 1997 (62 FR 46517).
    The NRC staff's efforts to update the Agreement State policy 
statements began with the Commission's direction provided in the SRM to 
SECY-10-0105, ``Final Rule: Limiting the Quanitity of Byproduct 
Material in a Generally Licensed Device (RIN 3150-AI33),'' issued on 
December 2, 2010 (ADAMS Accession No. ML103360262). The Commission 
directed the NRC staff to update the Commission's ``Policy Statement on 
Adequacy and Compatibility of Agreement State Programs'' and associated 
guidance documents to include both safety and source security 
considerations in the determination process. Because Agreement State 
adequacy and compatibility are key components of the Integrated 
Materials Performance Evaluation Program (IMPEP),\3\ the Commission's 
``Statement of Principles and Policy for the Agreement State Program'' 
was revised concurrently. As directed, the NRC staff's revisions to the 
policy statements added that public health and safety includes physical 
protection of agreement material.
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    \3\ The NRC developed the IMPEP to evaluate the adequacy and 
compatibility of Agreement State programs and the adequacy of the 
NRC's nuclear materials program activities.
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    The Commission approved publication of the proposed updates to the 
two policy statements in the revised SRM to SECY-12-0112, ``Policy 
Statements on Agreement State Programs,'' dated May 28, 2013 (ADAMS 
Accession No. ML13148A352). The NRC staff published the two proposed 
policy statements on June 3, 2013 (78 FR 33122), for a 75-day comment 
period. After receiving requests from the Organization of Agreement 
States (OAS) and the State of Florida to extend the public comment 
period, the NRC extended the comment period to September 16, 2013 (78 
FR 50118; August 16, 2013). The NRC held two public meetings (July 18 
and August 6, 2013), and a topical session during the OAS annual 
meeting in Reno, Nevada on August 28, 2013. The NRC staff specifically 
solicited comment on Compatibility Category B, and whether or not the 
policy statements should maintain the language from the 1997 ``Policy 
Statement on Adequacy and Compatibility of Agreement State Programs'' 
describing the adoption and number of compatible regulations.
    The NRC staff received 51 comments on the policy statements, in 
general, and 45 comments on Compatibility Category B from 13 
commenters, including Agreement States, industry organizations, and 
individuals. Consistency and flexibility were underlying themes 
expressed in the comments. The need for consistent application of the 
NRC's policies and flexible implementation of these policies was 
mentioned in written comments, and was also expressed orally during the 
public meetings and OAS topical session. The NRC changed the policy 
statements as a result of the written comments and input from attendees 
to the two public meetings and the OAS topical session.
    In COMSECY-14-0028, ``Agreement State Program Policy Statements: 
Update on Recent Activities and Recommendations for Path Forward,'' 
dated July 14, 2014 (ADAMS Accession No. ML14156A277), the NRC staff 
proposed a plan to provide a consolidated policy statement. The 
Commission approved this plan in the SRM to COMSECY-14-0028, dated 
August 12, 2014 (ADAMS Accession No. ML14224A618). Accordingly, the NRC 
staff developed a single consolidated proposed policy statement for 
comment. In finalizing the policy statement, NRC staff identified and 
eliminated redundant language between the two policy statements, and 
removed detailed information on IMPEP and the ``Principles of Good 
Regulation'' (ADAMS Accession No. ML15083A026), as this material is not 
typically included in a high-level policy statement. The proposed 
single policy statement is included in its entirety in Section IV, 
``Proposed Policy Statement for the Agreement State Program,'' of this 
document.

III. Discussion of Proposed Changes

    The NRC's proposed consolidated policy statement addresses the 
Commission direction in the SRMs to SECY-10-0105, SECY-12-0112, and 
COMSECY-14-0028 and reflects written public comments and input received 
from public meetings and the OAS topical session. The NRC staff's 
disposition of comments is presented in a comment resolution table 
(ADAMS Accession No. ML14073A549).
    The Commission's proposed consolidated policy removes details on 
IMPEP and the ``Principles of Good Regulation.'' The NRC added context 
and makes the proposed policy statement clearer and more consistent 
with other recent NRC policy statements. Lastly, the Commission added a 
description of the National Materials Program (NMP).
    In response to the Federal Register notice (FRN) on June 3, 2013 
(78 FR 33122), 45 comments were received on the description of 
Compatibility Category B in the proposed policy statement. In the FRN, 
the NRC specifically solicited comment on the following topics 
concerning Compatibility Category B:
    1. To clarify the meaning of a ``significant transboundary 
implication,'' \4\ the NRC is proposing to define a significant 
transboundary implication as ``one which crosses regulatory 
jurisdictions, has a particular impact on public health and safety, and 
needs to be addressed to ensure uniformity of regulation on a 
nationwide basis.'' However, the NRC

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recognizes that the use of the word ``particular'' can be vague and 
cause confusion. The NRC is requesting specific comments on the 
proposed draft definition of ``significant transboundary implication'' 
and whether the word ``particular'' should be replaced with the phrase 
``significant and direct.''
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    \4\ The NRC staff solicited public comment on the phrase 
``significant transboundary implication'' in the Federal Register on 
June 3, 2013 (78 FR 33122).
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    Based on comments received, the NRC staff noted that there is a 
wide variation on the interpretation of the description of 
Compatibility Category B and of the definition of significant 
transboundary implication. In light of this, the Commission is 
proposing a new description of Compatibility Category B to eliminate 
the phrase ``significant transboundary implication.'' The new language, 
(i.e., ``cross jurisdictional boundaries'') embodies the original 
description of Compatibility Category B and eliminates the confusion 
surrounding the language incorporated into the 1997 version of the 
policy statement.
    2. Program elements with significant transboundary implications are 
illustrated by examples in the 1997 version of the policy statement. 
The NRC staff concluded the examples listed are not all-inclusive and 
could lead to misinterpretation by stakeholders, Agreement States, and 
the NRC staff. The NRC staff is seeking additional comment on whether 
or not the examples should be retained in this section of the policy 
statement.
    The majority of commenters requested that examples of program 
elements considered Compatibility Category B continue to be included in 
the description. No changes were made to the policy statement. The 
Commission retained examples in Section E.2.ii.
    3. The NRC is requesting comments on the description of 
Compatibility Category B as written in Section IV. of this notice and 
whether or not the movement of goods and services, which historically 
has been a main factor in determining whether an issue has 
transboundary implications, should be considered in the definition of 
significant transboundary implication.
    Specific comments were received regarding the consideration of the 
movement of goods and services. The majority of the commenters felt 
that it was not necessary to include the consideration of the movement 
of goods and services in the description of Compatibility Category B. 
The Commission has concluded that the movement of goods and services 
should not be considered in assessing compatibility and made no change 
to the proposed policy statement.
    4. The NRC is requesting comments on whether or not economic 
factors should be a consideration when making a Compatibility Category 
B determination. The NRC believes that health and safety should be the 
primary consideration in making a Compatibility B determination and 
that economic factors should not be a consideration.
    The comments included several comments that differed on whether or 
not economic factors should be considered. Based on the comments 
received and in reviewing previous rationale on this topic as discussed 
in SECY-95-112 ``Final Policy Statement on Adequacy and Compatibility 
of Agreement State Programs,'' the Commission determined that economic 
factors (i.e., those costs incurred by the regulated community to 
comply with regulatory requirement(s)) should not be considered. No 
change to the proposed policy statement has been made.
    The NRC also solicited specific comment on the use of alternative 
wording regarding the expectation on the number of regulatory 
requirements that Agreement States will be requested to adopt in an 
identical manner to maintain compatibility. The 1997 version of the 
policy statement had specific text in three places regarding the 
expectation for adopting requirements in an identical manner to 
maintain compatibility. Six commenters supported returning the wording 
back to the text that was originally published in 1997. Based on 
comments received, the Commission retained the original language from 
the 1997 version in the proposed policy statement.
    Two commenters questioned the description of Compatibility Category 
D and indicated the description in the policy statement as published in 
the Federal Register on June 3, 2013 (78 FR 33122), appears to discuss 
compatibility in general and does not describe Compatibility Category D 
as it is defined in Management Directive 5.9, ``Adequacy and 
Compatibility of Agreement State Programs'' (ADAMS Accession No. 
ML041770094). The Commission agreed and moved the language listed under 
Compatibility Category D, in the proposed policy statement, to the 
introductory paragraph of Section E.2., ``Compatibility,'' and revised 
the description of Compatibility Category D in Section E.2.iv.
    The criteria for adequacy and compatibility as proposed in this 
policy statement will provide Agreement States with flexibility in the 
administration of their individual programs. Recognizing that Agreement 
States have responsibilities for radiation sources other than agreement 
material, this proposed policy statement would allow Agreement States 
to fashion their programs so as to reflect specific State needs and 
preferences while accomplishing a compatible national program 
consistent with Section 274 of the AEA.
    The requirements in Compatibility Categories A, B, and C will 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 Agreement States' need 
for flexibility and the need for coherent and compatible regulation of 
agreement material across the country.

IV. Proposed Policy Statement for the Agreement State Program

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).\5\ 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 ``Policy Statement on Adequacy and 
Compatibility of Agreement State Programs'' and the ``Statement of 
Principles and Policy for the Agreement State Program.''
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    \5\ 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 and secure 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

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term to describe the broad collective effort within which both NRC and 
the Agreement States function in carrying out their respective 
regulatory programs for agreement material. The mission 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. Under the NMP, the NRC and Agreement 
States function as regulatory partners. The roles and responsibilities 
of the NRC and the Agreement States are based on their legislative 
authority, program needs, and expertise. Two national organizations--
the Organization of Agreement States (OAS) and Conference of Radiation 
Control Program Directors, Inc. (CRCPD)--which are composed of State 
radiation protection programs, also play important roles within the 
NMP.

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 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., which 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 
Commission'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's regulatory oversight has included developing and 
implementing enhanced security measures. For the purposes of this 
policy statement, public health and safety includes 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 relinquishment or 
abdication by the Commission 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 compatible with the NRC program for the regulation of 
agreement material and that the State program is adequate to protect 
public health and safety. 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 
assessment 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

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serve as a guide to both agency decision making and to 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 Assessment
    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 assessment is needed. 
The NRC, in cooperation with the Agreement States, established and 
implemented the IMPEP. The IMPEP is a performance evaluation process 
that provides the NRC and Agreement State management with systematic, 
integrated, and reliable evaluations of the strengths and weaknesses of 
their respective radiation control programs and identification of areas 
needing improvement.
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 and cooperatively implemented by the NRC and the 
Agreement States and also should provide uniformity and achieve common 
strategic outcomes in program areas having national significance.
    Such areas of national significance 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 a strong 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 a number of documents in support of the certification. 
These documents include the State's enabling legislation, the radiation 
control regulations, 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 content these documents 
are required to cover. The NRC reviews the request and publishes notice 
of the proposed agreement in the Federal Register to provide an 
opportunity for public comment. After consideration of public comments, 
if the 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 a formal 
document memorializing 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 opportunities and offer other 
assistance such as review of proposed regulatory changes to help 
Agreement States administer their regulatory responsibilities. However, 
it is the responsibility of the Agreement State to ensure that they 
have a sufficient number of qualified staff to implement their 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.

[[Page 35393]]

    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 they continue to be 
adequate and compatible after an agreement becomes effective.
    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 
State management with systematic, integrated, and reliable evaluations 
of the strengths and weaknesses of their respective radiation control 
programs and identification of areas needing improvement. 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, composed of senior NRC managers and 
an Agreement State liaison provided by the OAS to make a determination 
of program adequacy and compatibility.
    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 a well-defined predictable 
process that is consistently and fairly applied.
5. Program Funding
    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 provide a similar opportunity to the NRC to make it aware 
of, and to provide the opportunity to review and comment on, proposed 
changes in regulations and significant changes to Agreement State 
programs, policies, and regulatory guidance.
    Two national organizations composed of State radiation protection 
programs 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 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 Compatibilty

    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 serves an overall nationwide interest 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 \6\ 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.
---------------------------------------------------------------------------

    \6\ 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

[[Page 35394]]

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 a reasonable 
assurance of protection of public health and safety. Therefore, the 
overall level of protection of public health and safety provided by a 
State program should be equivalent to, or greater than, the level 
provided by the NRC program. To provide reasonable assurance of 
protection of public health and safety, an Agreement State program 
should contain the five essential program elements, identified in items 
i. through v. of this section, that the NRC and Agreement States will 
use to define the scope of the review 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.
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 consistent with 
applicable Federal statutes. In addition, the State should have 
existing legally enforceable measures such as generally applicable 
rules, orders, license provisions, or other appropriate measures, 
necessary to allow the State to ensure adequate protection of public 
health and safety in the regulation of agreement material in the State. 
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 against 
licensees 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 radiation 
protection. An Agreement State has the flexibility to adopt and 
implement program elements within the State's jurisdiction that are not 
addressed by the NRC, or program elements not required for 
compatibility (i.e., those NRC program elements not assigned to 
Compatibility 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 Commission 
to evaluate the effectiveness of the NRC and 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.\7\ Also 
included in this category are a limited number of definitions, signs, 
labels, and scientific terms that are necessary for a common 
understanding of radiation protection principles among licensees, 
regulatory agencies, and members of the public. Such State standards 
should be essentially identical to those of the 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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    \7\ 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 small number of program elements that 
cross jurisdictional boundaries and that should be addressed to ensure 
uniformity of regulation on a nationwide basis. Examples include, but 
are not limited to, sealed source and device registration certificates, 
transportation regulations, and radiography certification. 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

[[Page 35395]]

protection of public health and safety, economic factors \8\ should not 
be considered.
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    \8\ 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.
---------------------------------------------------------------------------

iii. Category C--Other NRC Program Elements
    These are other 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 should 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
    These are 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
    These are program elements over which the NRC cannot discontinue 
its regulatory authority pursuant to the AEA or provisions of title 10 
of the Code of Federal Regulations. However, an Agreement State may 
inform its licensees of these NRC 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.

    Dated at Rockville, Maryland, this 25th day of May, 2016.

    For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary for the Commission.
[FR Doc. 2016-13006 Filed 6-1-16; 8:45 am]
 BILLING CODE 7590-01-P