[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
[[Page 35390]]
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
[[Page 35391]]
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
[[Page 35392]]
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.
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\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.
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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