[Federal Register Volume 62, Number 170 (Wednesday, September 3, 1997)]
[Notices]
[Pages 46517-46525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23330]
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NUCLEAR REGULATORY COMMISSION
Statement of Principles and Policy for the Agreement State
Program; Policy Statement on Adequacy and Compatibility of Agreement
State Programs
AGENCY: Nuclear Regulatory Commission.
ACTION: Final policy statements.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is publishing two
final policy statements: the ``Statement of Principles and Policy for
the Agreement State Program,'' and ``Policy Statement on Adequacy and
Compatibility of Agreement State Programs.''
EFFECTIVE DATE: September 3, 1997.
ADDRESSES: Documents referenced in this notice are available for
inspection in the Public Document Room, 2120 L Street, NW (Lower
Level), Washington, DC, between 7:45 am and 4:15 pm.
FOR FURTHER INFORMATION CONTACT: Ms. Cardelia Maupin, Sr. Project
Manager, Office of State Programs, U.S. Nuclear Regulatory Commission,
Washington, DC 20555, telephone (301) 415-2312.
SUPPLEMENTARY INFORMATION:
I. Background
A. Statement of Principles and Policy for the Agreement State Program
On August 25, 1993, the Commission requested the NRC staff to
recommend improvements to the NRC's Agreement State Program to assure
adequate protection of public health and safety. The draft Policy
Statement was published in the Federal Register on August 5, 1994 (59
FR 40058). At the Commission's request, the public comment period
scheduled to end on October 4, 1994, was extended to December 19, 1994
(59 FR 52316).
A final Policy Statement was prepared based on the public comments,
other activities and issues before the Commission, e.g., the ``Policy
Statement on Adequacy and Compatibility of Agreement State Programs,''
issues discussed at public briefings of the Commission by the
Organization of Agreement States (OAS), and the Commission's
deliberations on the Integrated Materials Performance Evaluation
Program. On May 5, 1995, the NRC staff submitted to the Commission the
``Final Statement of Principles and Policy for the Agreement State
Program'' and ``Procedures for Suspension and Termination of an
Agreement State Program'' (SECY 95-115) that contained the full
analysis of
[[Page 46518]]
comments. By Staff Requirements Memorandum dated June 29, 1995, the
Commission provided comments on the Statement of Principles and Policy
for the Agreement State Program and directed staff to develop
procedures for placing an Agreement State in probationary status and
for implementing the phase-in of a new Agreement State program.
On October 3, 1996, the NRC staff submitted to the Commission the
Statement of Principles and Policy for the Agreement State Program that
had been modified as directed by the Commission (SECY 96-213). Further
revisions were made to ensure consistency with the revised Policy
Statement on Adequacy and Compatibility of Agreement State Programs.
The procedures for suspension, emergency suspension and termination of
agreements were finalized on April 25, 1996, and the procedure for
placing an Agreement State in probationary status was finalized on July
3, 1996.
B. Statement on Adequacy and Compatibility of Agreement State Programs.
On July 21, 1994 (59 FR 37269), the Commission published in the
Federal Register, for public comment, a draft Policy Statement
regarding the adequacy of Agreement State programs to protect public
health and safety and compatibility with NRC regulatory programs. The
comment period for the draft Policy Statement was scheduled to expire
on October 19, 1994, but was extended to December 19, 1994 (59 FR
52317). In addition, a public workshop was held on November 15, 1994
(59 FR 52321) to provide an opportunity for Agreement States and
interested members of the public to provide comments on the draft
Policy Statement.
A final ``Policy Statement on Adequacy and Compatibility of
Agreement State Program'' was prepared based on the public comments and
other activities and issues before the Commission. On May 3, 1995, the
NRC staff submitted to the Commission the ``Final Policy Statement on
Adequacy and Compatibility of Agreement State Programs'' (SECY 95-112)
that contained the full analysis of comments.
C. Status of the Policy Statements
The Commission approved both policy statements in principle with a
Staff Requirements Memorandum dated June 29, 1995, but deferred their
implementation until all implementing procedures were completed and
approved by the Commission. On August 2, 1995 (60 FR 39463), the
Commission published in the Federal Register the status of these two
policy statements and a notice of their availability.
NRC staff also prepared draft implementing procedures for phased
implementation of a new Agreement State program that contained language
for a standard agreement (Management Directive 5.8 and its associated
handbook). Comments on the draft implementing procedures for phased
implementation of new agreements and the standard agreement were
requested from the Agreement States on November 15, 1996. The complete
analysis of these comments is included in ``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''
(SECY 97-054, dated March 3, 1997) that is available for inspection at
the NRC Public Document Room. A summary of the comments appears with
the text of the final policy statement in this notice.
In October 1995, a Working Group consisting of representatives of
Agreement States and the NRC was formed to develop implementing
procedures for the ``Policy Statement on Adequacy and Compatibility of
Agreement State Programs.'' The formation of this Working Group was
announced in the Federal Register on December 1, 1995 (60 FR 61716). A
notice announcing availability of the initial Working Group report
(August 21, 1996) and implementing procedures was published in the
Federal Register on September 19, 1996 (61 FR 49357). Comments also
were requested specifically from Agreement States and panelists who
participated in the November 15, 1994, public workshop. The analysis of
State and public comments is part of the supplemental report of the
Working Group dated January 27, 1997, that is available for inspection
at the NRC Public Document Room. A summary of the comments appears with
the text of the final policy statement in this notice.
II. Statement of Principles and Policy for the Agreement State
Program
A. Comment Summary
Comment letters were received from twelve Agreement States on the
implementing procedures for phased agreements (Management Directive
5.8). There was strong opposition from the Agreement States on the
inclusion of mandatory phased agreements for states seeking Agreement
State status. Staff analyzed the comments and agreed with the concerns
associated with the use of phased agreements. Changes were made to the
Policy Statement to remove the phased agreement concept and to include
revisions offered by the Agreement States, as appropriate. The Policy
Statement was also edited to conform it to the position that Agreement
States have flexibility to impose legally binding requirements on its
licensees through mechanisms other than rules.
The text of the final policy statement follows.
B. The Commission Policy
Statement of Principles and Policy for the Agreement State Program
1. Purpose: The purpose of this Statement of Principles and Policy
for the Agreement State Program is to clearly describe the respective
roles and responsibilities of the U.S. Nuclear Regulatory Commission
(NRC) and States in the administration of programs carried out under
Section 274 of the Atomic Energy Act of 1954, as amended. Section 274
provides broad authority for the NRC to establish Federal and State
cooperation in the administration of regulatory programs for the
protection of public health and safety in the industrial, medical, and
research uses of nuclear materials.
This Policy Statement addresses the Federal-State interaction under
the Atomic Energy Act to: (1) Establish and maintain agreements with
States under Section 274(b) that provide for discontinuance by the NRC,
and the assumption by the State, of responsibility for administration
of a regulatory program for the use of byproduct, source, and small
quantities of special nuclear material; and (2) ensure that post-
agreement interactions among the NRC and Agreement State radiation
control programs are coordinated and compatible and that Agreement
State programs continue to provide adequate protection of public health
and safety.
This Policy Statement establishes principles, objectives, and goals
that the Commission expects will be reflected in the implementing
guidance and programs of the NRC and Agreement States to meet their
respective program responsibilities and that should be achieved in the
administration of these programs.
This Policy Statement is intended solely as guidance for the
Commission and the Agreement States in the implementation of the
Agreement State program. This Policy Statement does not itself impose
legally binding
[[Page 46519]]
requirements on the Agreement States. In addition, nothing in this
Policy Statement expands the legal authority of Agreement States beyond
that already granted to them by Section 274 of the AEA and other
relevant legal authority. Implementation procedures adopted pursuant to
this Policy Statement shall be consistent with the legal authorities of
the Commission and the Agreement States.
2. Statement of Legislative Intent: The Atomic Energy Act of 1954
did not specify a role for the States in regulating the use of nuclear
materials. Many States were concerned as to what their responsibilities
in this area might be and expressed interest in seeing that the
boundaries of Federal and State authority were clearly defined. This
need for clarification was particularly important in view of the fact
that although the Federal government retained sole responsibility for
protecting public health and safety from the radiation hazards of
byproduct, source, and special nuclear material, the responsibility for
protecting the public from the radiation hazards of other sources such
as x-ray machines and radium had been borne for many years by the
States.
Consequently, in 1959 Congress enacted Section 274 of the Atomic
Energy Act to establish a statutory framework under which States could
assume certain regulatory jurisdiction over byproduct, source, and
special nuclear material in quantities less than a critical mass. The
primary purpose of the legislation was to authorize the Commission to
discontinue its regulatory authority over the use of these materials
and for assumption of this authority by the States. The Commission
retained regulatory authority over the licensing of certain facilities
and activities such as nuclear reactors, larger quantities of special
nuclear material, and the export and import of nuclear materials.
In considering the legislation, Congress recognized that the
Federal government would need to assist the States to ensure that they
developed the capability to exercise their regulatory authority in a
competent and effective manner. Accordingly, the legislation authorized
the Commission to provide training and other services to State
officials and employees. However, in rendering this assistance,
Congress did not intend that the Commission would provide any grants to
a State for the administration of a State regulatory program. This was
fully consistent with the objectives of Section 274 to qualify States
to assume independent regulatory authority over certain defined areas
of regulatory jurisdiction and to permit the Commission to discontinue
its regulatory responsibilities in those areas.
In order to relinquish its authority to a particular State, the
Commission must find that the program is compatible with the
Commission's program for the regulation of radioactive materials and
that the State program is adequate to protect public health and safety.
In addition, the Commission has an obligation, pursuant to Section
274(j) of the Act, to review existing Agreement State programs to
ensure continued adequacy and compatibility. Section 274(j) of the Act
provides that the NRC may terminate or suspend all or part of its
agreement with a State if the Commission finds that such termination is
necessary to protect public health and safety or that the State has not
complied with the provisions of Section 274(j). In these cases, the
Commission must offer the State reasonable notice and opportunity for a
hearing. In addition, the Commission may temporarily suspend all or
part of an agreement in the case of an emergency situation.
C. Principles of Program Implementation
1. Good Regulation Principles
In 1991, the Commission adopted ``Principles of Good Regulation''
to serve as a guide to both agency decision making and to individual
behavior as NRC employees. Adherence to these principles has helped to
ensure that NRC's regulatory activities have been of the highest
quality, appropriate, and consistent. The ``Principles of Good
Regulation'' recognize that strong, vigilant management and a desire to
improve performance are prerequisites for success, for both regulators
and the regulated industry. The Commission believes that NRC's
implementation of these principles has served the public, the Agreement
States, and the regulated community well. The Commission further
believes that such principles may be useful as a part of a common
culture that NRC and the Agreement States share as co-regulators.
Accordingly, the Commission encourages each Agreement State to adopt a
similar set of principles for use in its own regulatory program.
Regulatory decisions and actions should be developed and
implemented in an open and publicly credible manner and should be able
to withstand scrutiny. Such scrutiny should be welcomed by the
regulator. The regulator should be independent and impartial in its
actions, and this should be clearly evident. Regulations and regulatory
decisions should be based on assessments of the best available
information from affected and interested individuals and organizations,
as well as on the best available knowledge from research and
operational experience. Significant decisions, for example, a change in
enforcement policy, should be documented explaining the rationale for
such decisions. The public should have an opportunity for early
involvement in significant regulatory program decisions. Where several
effective alternatives are available, the alternative that best assures
safety while considering differing views should be adopted, considering
the resources needed to implement that alternative. Regulations should
be necessary, and appropriate, to assure safety, and should be clear,
coherent, logical, and practical. Regulatory actions should be fully
consistent with regulations or other legally binding requirements and
good public policy and should lead to stability and predictability in
the planning and implementation of radiation control programs.
Failure to adhere to these principles of good regulation in the
conduct of operations should be a sufficient reason for a regulatory
program to self-initiate program changes that will result in needed
improvements. All involved should welcome expressions of concern that
indicate a program may not be operating in accordance with these
principles and revise their program to more completely reflect these
principles.
It is not intended that these principles of good regulation be
established as formal criteria against which NRC and Agreement State
programs would be assessed. Rather, the expectation is that these
principles will be incorporated into the day-to-day operational fabric
of NRC and Agreement State materials programs. These principles should
be used in the formulation of policies and programs, implementation of
those policies and programs, and assessments of program effectiveness.
Application of these principles will ensure that complacency will be
minimized, that adequate levels of protection of public health and
safety are being provided, and that government employees tasked with
the responsibility for these Federal and State regulatory programs
serve the public in an effective, efficient, and responsive manner.
These principles are primarily for the use of NRC and Agreement State
materials program managers and staff in the self assessment of their
respective programs and to use in the establishment of goals and
objectives for the continual improvement of their respective
[[Page 46520]]
programs. Deficiencies identified during the conduct of NRC Region and
Agreement State formal program performance reviews may indicate that
the program is not adhering to these principles of good regulation. The
organization being assessed should factor the need for these principles
into its actions to address identified deficiencies.
2. Coherent Nationwide Effort
The mission of the NRC is to assure that civilian use of nuclear
materials in the United States is carried out with adequate protection
of public health and safety. NRC acknowledges its responsibility,
shared with the Agreement States, to ensure that the regulatory
programs of the NRC and the Agreement States collectively establish a
coherent nationwide effort for the control of AEA materials. The basic
elements of such regulatory programs include ability to ensure adequate
protection of public health and safety, compatibility in areas of
national interest, sufficient flexibility to accommodate local needs
and conditions, ability to assess program performance on a consistent
and systematic basis, and principles of good regulation in program
administration.
Each of these elements is reflected and addressed in specific
sections of this Policy Statement.
3. Adequate to Protect Public Health and Safety
NRC and the Agreement States have the responsibility to ensure
adequate protection of public health and safety in the administration
of their respective regulatory programs controlling the uses of AEA
materials. Accordingly, NRC and Agreement State programs shall possess
the requisite supporting legislative authority, implementing
organization structure and procedures, and financial and human
resources to effectively administer a radiation control program that
ensures adequate protection of public health and safety.
4. Compatible in Areas of National Interest
NRC and the Agreement States have the responsibility to ensure that
consistent and compatible radiation control programs are administered.
Such radiation control programs should be based on a common regulatory
philosophy including the common use of definitions and standards. They
should be not only effective and cooperatively implemented by NRC and
the Agreement States, but also should provide uniformity and
consistency in program areas having national significance.
Such areas include those affecting interstate commerce, movement of
goods and provision of services, and safety reviews for sealed source
devices sold nationwide. Also necessary is the ability to communicate
using a nationally accepted set of terms with common understanding, the
ability to ensure an adequate level of protection of public health and
safety that is consistent and stable across the nation, and the ability
of NRC and each Agreement State to evaluate the effectiveness of the
NRC and Agreement State programs for the regulation of agreement
material with respect to protection of public health and safety.
5. Flexibility
With the exception of those compatibility areas where all programs
should be essentially identical, to the extent possible, Agreement
State radiation control programs for AEA materials should be provided
with flexibility in program implementation to accommodate individual
State preferences, State legislative direction, and local needs and
conditions. However, the exercise of such flexibility should not
preclude, or effectively preclude, a practice authorized by the Atomic
Energy Act, and in the national interest. That is, a State would have
the flexibility to design its own program, including incorporating more
stringent, or similar, requirements provided that the requirements for
adequacy are still met and compatibility is maintained, and the more
stringent requirements do not preclude or effectively preclude a
practice in the national interest without an adequate public health and
safety or environmental basis related to radiation protection.
D. New Agreements
Section 274 of the Atomic Energy Act requires that once a decision
to seek Agreement State status is made by the State, the Governor of
that State must certify to the NRC that the State desires to assume
regulatory responsibility and has a program for the control of
radiation hazards adequate to protect public health and safety with
respect to the materials within the State covered by the proposed
agreement. This certification will be provided in a letter to the NRC
that includes a number of documents in support of the certification.
These documents include the State's enabling legislation, the radiation
control regulations, a narrative description of the State program's
policies, practices and procedures, and a proposed agreement.
The NRC has published criteria describing the necessary content
these documents are required to cover. The NRC reviews the request and
publishes notice of the proposed agreement in the Federal Register to
provide an opportunity for public comment. After consideration of
public comments, if the Commission determines that the State program is
adequate and compatible, and approves the agreement, a formal agreement
document is signed by the Governor and the Chairman of the NRC.
E. Program Assistance
NRC will offer training and other assistance to States, such as
assistance in developing regulations and program descriptions to help
individual States prepare for entrance into agreements and to help them
prior to the assumption of regulatory authority. Following assumption
of regulatory authority by a new Agreement State, to the extent
permitted by resources, NRC can provide training and other assistance
such as review of proposed regulatory changes to help States administer
their regulatory responsibilities. NRC would also use its best efforts
to provide specialized technical assistance to Agreement States to
address unique or complex licensing, inspection, and enforcement
issues. In areas where Agreement States have particular expertise or
are in the best position to provide immediate assistance to the NRC,
the Agreement States are encouraged to do so. In addition, NRC and
Agreement States will keep each other informed about relevant aspects
of their programs. NRC will provide an opportunity for Agreement States
to have early and substantive involvement in rulemaking, policy, and
guidance development activities. Agreement States should provide a
similar opportunity to the NRC to make it aware of, and to provide the
opportunity to review and comment on, proposed changes in regulations
and significant changes to Agreement State programs, policies, and
regulatory guidance.
If an Agreement State experiences difficulty in program
administration, the Commission would use its best efforts to assist the
State in maintaining the effectiveness of its radiation control
program. Such assistance could address an immediate difficulty or a
chronic difficulty affecting the State's ability to discharge its
responsibility to continue to ensure adequate protection of public
health and safety.
F. Performance Evaluation
Under Section 274 of the Atomic Energy Act of 1954, as amended, the
[[Page 46521]]
Commission retains authority for ensuring that Agreement State programs
continue to provide adequate protection of public health and safety. In
fulfilling this statutory responsibility, NRC will provide oversight of
Agreement State radiation control programs to ensure that they are
adequate and compatible prior to entrance into a Section 274(b)
agreement and that they continue to be adequate and compatible after an
agreement is effective. The Commission, in cooperation with the
Agreement States, will establish and implement a performance evaluation
program to provide 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.
As a part of this performance evaluation process, the Commission
will take any necessary actions to help ensure that Agreement State
radiation control programs remain adequate and compatible. These
actions include: (1) Periodic assessments of Agreement State radiation
control programs against established review criteria; (2) provision of
assistance to help address weaknesses or areas within an Agreement
State radiation control program requiring improvement, to the extent
permitted by NRC resources; (3) placing a State on a probationary
status for serious program deficiencies that require heightened
oversight; (4) temporary suspension of an agreement and reassertion of
NRC regulatory authority in an emergency if an Agreement State program
experiences any immediate program difficulties preventing the State
from continuing to ensure adequate protection of public health and
safety; and (5) suspension or termination of an agreement and
reassertion of NRC regulatory authority if the Agreement State program
experiences difficulties that jeopardize the State's ability to
continue to ensure adequate protection of public health and safety or
to continue to maintain a compatible program. The basis for NRC's
actions will be based on a well defined and predictable process and a
performance evaluation program that will be consistently and fairly
applied.
G. Levels of Agreement State Program Review Findings
The following discussion outlines the nature of NRC findings
regarding the NRC's Agreement State review process.
Finding 1--Adequate To Protect Public Health and Safety and (or not)
Compatible
If the NRC finds that a State program has met all of the Agreement
State program review criteria or that only minor deficiencies exist,
the Commission would find that the State's program is adequate to
protect public health and safety. If the NRC determines that a State
program contains all required NRC program elements for compatibility,
or only minor discrepancies exist, the program would be found
compatible. If the NRC determines that a State has a program that
disrupts the orderly pattern of regulation among the collective
regulatory efforts of the NRC and other Agreement States, i.e., creates
conflicts, gaps, or duplication in regulation, the program would be
found not compatible.
Finding 2--Adequate, but Needs Improvement and (or not) Compatible
If the NRC finds that a State program protects public health and
safety, but is deficient in meeting some of the review criteria, the
NRC may find that the State's program is adequate, but needs
improvement. The NRC would consider in its determination plans that the
State has to address any of the deficiencies noted during the review.
In cases where less significant Agreement State deficiencies previously
identified have been uncorrected for a significant period of time, NRC
may also find that the program is adequate but in need of improvement.
If the NRC determines that a State program contains all required NRC
program elements for compatibility, or only minor discrepancies exist,
the program would be found compatible. If the NRC determines that a
State has a program that disrupts the orderly pattern of regulation
among the collective regulatory efforts of the NRC and other Agreement
States, i.e., creates conflicts, gaps, or duplication in regulation,
the program would be found not compatible.
Finding 3--Inadequate to Protect Public Health and Safety and (or not)
Compatible
If the NRC finds that a State program is significantly deficient in
some or all of the review criteria, the NRC would find that the State's
program is not adequate to protect public health and safety. If the NRC
determines that a State program contains all required NRC program
elements for compatibility, or only minor discrepancies exist, the
program would be found compatible. If the NRC determines that a State
has a program that disrupts the orderly pattern of regulation among the
collective regulatory efforts of the NRC and other Agreement States,
i.e., creates conflicts, gaps, or duplication in regulation, the
program would be found not compatible.
H. NRC Actions as a Result of These Findings
The following discussion outlines the options available to the NRC
as a result of making any of the above findings. The appropriate action
will be determined on a case-by-case basis by NRC management.
Letters
In all cases, subsequent to an Agreement State program review, the
findings would be recounted in a letter to senior level State
management. In the event that the NRC finds that a State program is
adequate and compatible, no further action would be required, except a
response by the State to any suggestions or recommendations. In the
case where minor deficiencies are noted or areas for improvement are
identified, the State would be requested to describe their proposed
corrective action. If the corrective action appears appropriate, no
further NRC action is required. If additional clarification of the
corrective actions is needed, additional correspondence may be
necessary.
Follow-up Reviews
In the event that deficiencies are noted during the program review,
NRC may increase the frequency of contacts with the State to keep
abreast of developments and conduct onsite follow-up reviews to assure
that progress is being made on correcting program deficiencies. If,
during follow-up reviews, it is shown that the State has taken
corrective actions, a letter finding the State adequate and compatible
would be provided.
Probationary Status
There are three circumstances that can lead to an adequate but
needs improvement or incompatible State program being placed in a
probationary status: (1) There are cases in which program deficiencies
may be serious enough to require immediate heightened oversight; (2) in
other cases, Agreement State program deficiencies previously identified
may have been uncorrected for a significant period of time; and (3) if
the NRC determines that a State program has been late in adopting
required compatibility program elements and significant disruption in
the collective nationwide efforts to
[[Page 46522]]
regulate AEA materials has occurred. If the NRC was not confident that
the State would address the program deficiencies in an expeditious and
effective manner, the Commission would place the State program on
probation.
As a result of placing a State program on probation, the NRC would
communicate its findings to a higher level of State management. Notice
of such probationary status would normally be addressed to the Governor
of the State. Notice would also be published in the Federal Register. A
copy of the letter to the Governor would be placed in the Public
Document Room and a press release would be issued.
Once a State program is placed on probation, the NRC would heighten
its oversight of the program. This would include obtaining commitments
from the State in the form of a management plan to describe actions to
be taken by the State to address the program deficiencies, including
specific goals and milestones. The NRC would increase observation of
State program activities under the agreement to assure adequate
protection of public health and safety. If requested and in accordance
with terms agreed to by the parties, the NRC would consider providing
technical support for the maintenance of the regulatory program. The
probationary period would last for a specified period of time. This
period would not normally be more than one year, but could be extended
based on extenuating circumstances. At the end of that time, if the
State has not addressed the deficiencies, the NRC would institute
suspension or termination proceedings.
Suspension
Section 274j of the Atomic Energy Act gives the Commission
authority to suspend all or part of its agreement with a State if the
suspension is required to protect public health and safety, or if the
State has not complied with one or more of the requirements of Section
274 of the Act. In cases where the Commission finds that program
deficiencies related to either adequacy or compatibility are such that
the Commission must take action to protect public health and safety, or
if the program has not complied with one or more of the requirements of
Section 274 of the Act, the Commission would suspend all or part of its
agreement with the State. In cases where a State has failed to respond
in an acceptable manner during the probationary period, suspension
would be considered. If the situation is not resolved, termination will
be considered.
Before reaching a final decision on suspension, the Commission will
notify the State and provide the State an opportunity for a hearing on
the proposed suspension. Notice of the proposed suspension will also be
published in the Federal Register. Suspension, rather than termination,
would be the preferred option in those cases where the State provides
evidence that the program deficiencies are temporary and that the State
is committed to correcting the deficiencies that led to the suspension.
In addition to the normal suspension authority, Section 274j(2) of
the Act also addresses emergency situations and gives the Commission
authority to temporarily suspend all or part of its agreement with a
State without notice or hearing if an emergency situation exists
requiring immediate action to protect public health and safety, and the
State has failed to take necessary action within a reasonable time.
Termination
Section 274j of the Atomic Energy Act gives the Commission
authority to terminate its agreement with a State if such termination
is required to protect public health and safety, or if the State
program has not complied with one or more of the requirements of
Section 274 of the Act (e.g., is found to be not compatible with the
Commission's program). When the Commission finds such significant
program deficiencies, the Commission would institute proceedings to
terminate its agreement with the State.
In cases where a State has failed to respond in an acceptable
manner during the probationary period and there is no prospect for
improvement, termination will be considered. Before reaching a final
decision on termination, the Commission will notify the State and
provide the State an opportunity for a hearing on the proposed
termination.
Also, notice of the proposed termination will be published in the
Federal Register. There may be cases where termination will be
considered even though the State program has not been placed on
probation.
I. Program Funding
Currently, Section 274 does not allow federal funding for the
administration of Agreement State radiation control programs. Section
274 permits the NRC to offer training and other assistance to a State
in anticipation of entering into an Agreement with NRC, however, it is
NRC policy not to fund the establishment of new Agreement State
programs. Regarding training, given the importance in terms of public
health and safety of having well trained radiation control program
personnel, the NRC offers certain relevant training courses and
notifies Agreement State personnel of their availability.
J. Regulatory Development
NRC and Agreement States will cooperate in the development of new
regulations and policy. Agreement States will have early and
substantive involvement in the development of new regulations affecting
protection of public health and safety and of new policy affecting
administration of the Agreement State program. Likewise, the NRC
expects to have the States provide it with early and substantive
involvement in the development of new Suggested State Regulations. NRC
and Agreement States will keep each other informed about their
individual regulatory requirements (e.g., regulations or license
conditions) and the effectiveness of those regulatory requirements so
that each has the opportunity to make use of proven regulatory
approaches to further the effective and efficient use of resources.
K. Program Evolution
The NRC-Agreement State program is dynamic and the NRC and
Agreement States will continue to jointly assess the NRC and Agreement
State programs for the regulation of AEA materials to identify specific
changes that should be considered based on experience or to further
improve overall performance and effectiveness. The changes considered
may include possible legislative changes. The program should also
include the formal sharing of information and views such as briefings
of the Commission by the Agreement States.
III. Policy Statement on Adequacy and Compatibility of Agreement State
Programs
A. Comment Summary
Ten comment letters were received, one from the Organization of
Agreement States, six Agreement State program directors, two industry
organizations and one environmental group. The Joint NRC-Agreement
State Working Group for Development of Implementing Procedures for the
Final Policy Statement on Adequacy and Compatibility of Agreement State
Programs analyzed the comments and changes were made to the Policy
Statement (1) to add additional clarifying language for the terms
``adequacy'' and ``compatibility'' and the cooperative nature of the
NRC--Agreement State relationship; (2) to
[[Page 46523]]
conform it to the position that Agreement States have flexibility with
respect to the legally binding mechanism by which regulatory
requirements needed for adequacy or compatibility are adopted; and (3)
to simplify the language describing compatibility categories. Changes
also were made in response to the June 30, 1997 Staff Requirements
Memorandum. These changes (1) reflect that program elements for
compatibility also impact public health and safety and may also be
considered program elements for adequacy; (2) clarify the definition of
basic radiation protection standard; and (3) clarify that States may
not adopt program elements reserved exclusively to NRC. The
implementing procedures were changed to reflect the final Policy
Statement.
One Agreement State specifically commented that it did not believe
that Section 274 of the AEA required compatibility of programs or
program elements after an agreement is effective except for
requirements pertaining to the Uranium Mill Tailings Radiation Control
Act in section 274(o). This position also was reflected in the
recommended changes to the Policy Statement submitted by the
Organization of Agreement States.
The Commission does not agree with this interpretation of the AEA.
Both Sections 274d.(2) and 274g. indicate that the Commission must find
a State program to be compatible with that of NRC in order to enter
into a Section 274b. agreement with the State. It is the Commission's
view that, pursuant to Section 274, an Agreement State's program should
be compatible with NRC's program for the duration of the Agreement for
the following reasons:
Subsection 274g. authorizes and directs the Commission to
cooperate with the States in the formulation of radiation protection
standards ``to assure that the State and Commission programs for the
protection against hazards of radiation will be coordinated and
compatible.'' This provision demonstrates Congress' intention that
the compatibility between the NRC and Agreement State programs
should be maintained on a continuing basis.
Section 274j.(1) calls on the Commission to suspend or terminate
an Agreement State's program if ``the State has not complied with
one or more of the requirements'' of the Section 274. The Commission
believes that this phrase ``one or more of the requirements,''
encompasses all requirements of Section 274, including the
requirement for compatibility.
Under subsection 274d.(2), the Commission is authorized to enter
into an agreement with a State if the Commission makes both
requisite findings that the State program is compatible with the
NRC's program and adequate to protect public health and safety.
Absent a continuing compatibility requirement, an Agreement State
could divert from having a compatible program the day after any
agreement is signed with NRC. This would render the Commission's
initial compatibility finding required by Section 274d.(2)
meaningless.
Therefore, the Commission does not believe that Congress intended
such meaning for the compatibility requirement and no changes were made
to the Policy Statement in response to this comment.
The text of the final policy statement follows.
B. The Commission Policy
Policy Statement on Adequacy and Compatibility of Agreement State
Programs
Purpose: Section 274 of the Atomic Energy Act (AEA) of 1954, as
amended, provides for a special Federal-State regulatory framework for
the control of radioactive materials under which the NRC, by agreement
with a State, relinquishes its authority in certain areas to the State
government as long as the State program is adequate to protect public
health and safety and compatible with the Commission's program. Section
274 further directs the Commission to periodically review State
programs to ensure compliance with provisions of Section 274. This
Policy Statement presents the Nuclear Regulatory Commission's policy
for determining the adequacy and compatibility of Agreement State
programs established pursuant to Section 274. This Policy Statement
clarifies the meaning and use of the terms ``adequate to protect public
health and safety'' and ``compatible with the Commission's regulatory
program'' as applied to the Agreement State program. The Policy
Statement also describes the general framework that will be used to
identify those program elements \1\ that Agreement State programs
should implement to be adequate to protect public health and safety and
to be compatible with the Commission's regulatory program. Finally, the
Policy Statement reflects principles discussed in the Commission's
Statement of Principles and Policy for the Agreement State Program
which should be considered in conjunction with this Policy Statement.
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\1\ For the purposes of this Policy Statement, ``program
element'' means any component or function of a radiation control
regulatory program, including regulations and/or other legally
binding requirements imposed on regulated persons, that contributes
to implementation of that program.
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This Policy Statement is solely guidance for the Commission and the
Agreement States in the implementation of the Agreement State program.
This Policy Statement does not itself impose legally binding
requirements on the Agreement States. In addition, nothing in this
Policy Statement expands the legal authority of Agreement States beyond
that already granted to them by Section 274 of the Atomic Energy Act
and other relevant legal authority. Implementation procedures adopted
pursuant to this Policy Statement shall be consistent with the legal
authorities of the Commission and the Agreement States.
Background: The terms ``adequate'' and ``compatible'' represent
fundamental concepts in the Agreement State program authorized in 1959
by Section 274 of the Atomic Energy Act of 1954, as amended (AEA).
Subsection 274d. states that the Commission shall enter into an
Agreement under subsection b., discontinuing NRC's regulatory authority
over certain materials in a State, provided that the State's program is
adequate to protect public health and safety and compatible, in all
other respects, with the Commission's regulatory program. Subsection
274g. authorizes and directs the Commission to cooperate with States in
the formulation of standards to assure that State and Commission
standards will be coordinated and compatible. Subsection 274j.(1)
requires the Commission to review periodically the Agreements and
actions taken by States under the Agreements to ensure compliance with
provisions of Section 274. In other words, the Commission must review
the actions taken by States under the Agreements to ensure that the
programs continue to be adequate to protect public health and safety
and compatible with the Commission's program.
Section 274 of the AEA requires that Agreement State programs be
both ``adequate to protect the public health and safety'' and
``compatible with the Commission's program.'' These separate findings
are based on consideration of two different objectives. First, an
Agreement State program should provide for an acceptable level of
protection of public health and safety in an Agreement State (the
``adequacy'' component). Second, the Agreement State should ensure that
its program serves an overall nationwide interest in radiation
protection (the ``compatibility'' component). As discussed in more
detail below, an ``adequate'' program should consist of those program
elements necessary to maintain an acceptable level of protection of
public health and safety within an Agreement State. A ``compatible''
program should consist of those program elements necessary to
[[Page 46524]]
meet a larger nationwide interest in radiation protection generally
limited to areas of regulation involving radiation protection standards
and activities with significant transboundary implications. Program
elements for adequacy focus on the protection of public health and
safety within a particular State, whereas program elements for
compatibility focus on the impacts of an Agreement State's regulation
of agreement material on a nationwide basis or its potential effects on
other jurisdictions. Many program elements for compatibility also
impact public health and safety; therefore, they may also be considered
program elements for adequacy.
In identifying those program elements for adequate and compatible
programs, or any changes thereto, the Commission will seek the advice
of the Agreement States and will consider such advice in its final
decision.
Adequacy: 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 source, byproduct, and small
quantities of special nuclear material (hereinafter termed ``agreement
material'') as identified by Section 274b. of the AEA. The level of
protection afforded by the program elements of NRC's materials
regulatory program is presumed to be that which is adequate to provide
a reasonable assurance of protection of public health and safety. 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 five essential program elements, identified below, that
the Commission will use to define the scope of its review of the
program. The Commission also will consider, when appropriate, other
program elements of an Agreement State which appear to affect the
program's ability to provide reasonable assurance of public health and
safety protection. Such consideration will occur only if concerns
arise.
A. Legislation and Legal Authority
State statutes should:
Authorize the State to establish a program for the regulation of
agreement material and provide authority for the assumption of
regulatory responsibility under an Agreement with the Commission;
Authorize the State to promulgate regulatory requirements
necessary to provide reasonable assurance of protection of public
health and safety;
Authorize the State to license, inspect, and enforce legally
binding requirements such as regulations and licenses; and
Be otherwise consistent with Federal statutes, as appropriate,
such as Pub. L. 95-604, The Uranium Mill Tailings Radiation Control
Act (UMTRCA).
In addition, the State should have existing legally enforceable
measures such as generally applicable rules, license provisions, or
other appropriate measures, necessary to allow the State to ensure
adequate protection of public health and safety in the regulation of
agreement material in the State. Specifically, Agreement States should
adopt a limited number of legally binding requirements based on those
of NRC because of their particular health and safety significance. In
adopting such requirements, Agreement States should adopt the essential
objectives of those of the Commission.
B. Licensing
The State should conduct appropriate evaluations of proposed uses
of agreement material, before issuing a license, to assure that the
proposed licensee's operations can be conducted safely. Licenses should
provide for reasonable assurance of public health and safety protection
in relation to the licensed activities.
C. Inspection and Enforcement
The State should periodically conduct inspections of licensed
activities involving agreement material to provide reasonable assurance
of safe licensee operations and to determine compliance with its
regulatory requirements. When determined to be necessary by the State,
the State should take timely enforcement action against licensees
through legal sanctions authorized by State statutes and regulations.
D. Personnel
The State should be staffed with a sufficient number of qualified
personnel to implement its regulatory program for the control of
agreement material.
E. Response to Events and Allegations
The State should respond to and conduct timely inspections or
investigations of incidents, reported events, and allegations involving
agreement material within the State's jurisdiction to provide
reasonable assurance of protection of public health and safety.
Compatibility
An Agreement State radiation control program is compatible with the
Commission's regulatory program when its program does not create
conflicts, duplications, gaps, or other conditions that would
jeopardize an orderly pattern in the regulation of agreement material
on a nationwide basis. For purposes of compatibility, the State should
address categories A, B, and C identified below:
A. Basic Radiation Protection Standards
For purposes of this Policy Statement, this category includes
``basic radiation protection standards'' meaning dose limits,
concentration and release limits related to radiation protection in 10
CFR part 20 that are generally applicable, and the dose limits in 10
CFR 61.41.2 Also included in this category are a limited
number of definitions, signs, labels and scientific terms that are
necessary for a common understanding of radiation protection principles
among licensees, regulatory agencies, and members of the public. Such
State standards should be essentially identical to those of the
Commission, unless Federal statutes provide the State authority to
adopt different standards. Basic radiation protection standards do not
include constraints or other limits below the level associated with
``adequate protection'' that take into account permissible balancing
considerations such as economic cost and other factors.
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\2\ The Commission will implement this category consistent with
its earlier decision in the LLW area to allow Agreement States
flexibility to establish pre-closure operational release limit
objectives, ALARA goals or design objectives at such levels as the
State may deem necessary or appropriate, as long as the level of
protection of public health and safety is at least equivalent to
that afforded by Commission requirements.
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B. Program Elements with Significant Transboundary Implications
The Commission will limit this category to a small number of
program elements (e.g., transportation regulations and sealed source
and device registration certificates) that have significant
transboundary implications. Agreement State program elements should be
essentially identical to those of the Commission.
C. Other Commission Program Elements
These are other Commission program elements (e.g., reciprocity
procedures) that are important for an Agreement State to have in order
to avoid conflicts, duplications, gaps, or other conditions that would
jeopardize an orderly pattern in the regulation of agreement material
on a nationwide basis. Such Agreement State program elements should
embody the essential objective of the corresponding Commission program
elements.
[[Page 46525]]
D. Program Elements not Required for Compatibility
An Agreement State has the flexibility to adopt and implement
program elements based on those of the Commission (other than those
identified in A, B, and C above) or other program elements within the
State's jurisdiction that are not addressed by NRC.
All program elements of an Agreement State relating to agreement
material should:
Be compatible with those of the Commission (i.e., should not
create conflicts, duplications, gaps, or other conditions that would
jeopardize an orderly pattern in the regulation of agreement
material on a nationwide basis);
Not preclude, or effectively preclude, a practice \3\ in the
national interest without an adequate public health and safety or
environmental basis related to radiation protection; or
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\3\ ``Practice'' means a use, procedure, or activity associated
with the application, possession, use, storage, or disposal of
agreement material. The term ``practice'' is used in a broad and
encompassing manner in this Policy Statement. The term encompasses
both general activities involving use of radioactive materials such
as industrial and medical uses and specific activities within a
practice such as industrial radiography and brachytherapy.
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Not preclude, or effectively preclude, the ability of the
Commission to evaluate the effectiveness of the NRC and Agreement
State programs for agreement material with respect to protection of
public health and safety.
E. Areas of Exclusive NRC Regulatory Authority
These are program elements that address areas of regulation that
cannot be relinquished to Agreement States pursuant to the AEA or
provisions of Title 10 of the Code of Federal Regulations. However, an
Agreement State may inform its licensees of certain of these NRC
provisions through a mechanism that is appropriate under the State's
administrative procedure laws as long as the State adopts these
provisions solely for the purposes of notification, and does not
exercise any regulatory authority pursuant to them.
Summary and Conclusions
To foster and enhance a coherent and consistent nationwide program
for the regulation of agreement material, the Commission encourages
Agreement States to adopt and implement program elements that are
patterned after those adopted and implemented by the Commission.
However, the fact that an Agreement State's program is compatible with
that of the Commission does not affect that State's obligation to
maintain an adequate program as described in this Policy Statement.
By adopting the criteria for adequacy and compatibility as
discussed in this Policy Statement the Commission will provide
Agreement States a broad range of flexibility in the administration of
individual programs. In doing so, the Commission allows Agreement
States to fashion their programs so as to reflect specific State needs
and preferences, recognizing the fact that Agreement States have
responsibilities for radiation sources in addition to agreement
material.
The Commission will minimize the number of NRC regulatory
requirements that the Agreement States will be requested to adopt in an
identical manner to maintain compatibility. At the same time,
requirements in these compatibility categories will allow the
Commission to ensure that an orderly pattern for the regulation of
agreement material exists nationwide. The Commission believes that this
approach achieves a proper balance between the need for Agreement State
flexibility and the need for coordinated and compatible regulation of
agreement material across the country.
* * * * *
Paperwork Reduction Act Statement
These final policy statements do not contain new or amended
information collection requirements subject to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.). Existing requirements were
approved by the Office of Management and Budget, approval number 3150-
0183.
Public Protection Notification
The NRC may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number.
Small Business Regulatory Enforcement Fairness Act
In accordance with the Small Business Regulatory Enforcement
Fairness Act of 1996, the NRC has determined that this action is not a
major rule and has verified this determination with the Office of
Information and Regulatory Affairs of OMB.
Dated at Rockville, Md., this 27th day of August, 1997.
For the Nuclear Regulatory Commission.
John C. Hoyle,
Secretary of the Commission.
[FR Doc. 97-23330 Filed 9-2-97; 8:45 am]
BILLING CODE 7590-01-P
