Draft Policy Statement on Agreement State Program

Federal RegisterAug 5, 1994

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NUCLEAR REGULATORY COMMISSION

Draft Policy Statement on Agreement State Program

AGENCY: Nuclear Regulatory Commission.

ACTION: Draft policy statement on Agreement State Program.

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The Nuclear Regulatory Commission staff is releasing the proposed

policy statement on the Agreement State Program for public comment. The

draft policy statement establishes Agreement State program principles,

and describes the respective roles and responsibilities of the NRC and

the States in the administration of this program, which is authorized

by Section 274 of the Atomic Energy Act of 1954, as amended. Agreement

States are States which have assumed regulatory authority from NRC over

the possession and use of certain radioactive materials.

On August 25, 1993, the Commission requested the NRC staff to

recommend improvements to the NRC's Agreement States Program to assure

adequate protection of the public health and safety. This draft policy

statement responds to the first area the Commission requested be

considered, ``improvements in guidance and principles of operations for

the Agreement State Program.'' This draft document is an ``umbrella''

policy statement which will serve as broad guidance in delineating the

NRC's and the State's respective responsibilities and expectations. In

this regard, the NRC especially requests comments on the following:

The Commission has proposed that the categories of findings made

about adequacy of an Agreement State's program be Adequate,

Marginally Adequate and Inadequate. For the Marginally Adequate

finding, the NRC action could be either (a) followup reviews, or (b)

probation with followup reviews, depending on whether or not NRC

were confident that the State would address the program deficiencies

in an expeditious and effective manner. Comment is requested as to

whether these three categories are appropriately and sufficiently

descriptive of the performance, or whether the ``Marginally

Adequate'' category needs to be subdivided such that States placed

on probation are not identified in the same category as those which

are not placed on probation.

In addition to the draft proposed ``Statement of Principles and

Policy For the Agreement State Program,'' a document provided to the

Commission entitled ``Specific Review Area Recommendations,'' and draft

internal procedures on the NRC process to be applied when a State

agreement is suspended or terminated, also are being made available for

public comment. We also request specific comments on the use of 10 CFR

Part 2, Subpart L ``Informal Hearing Procedures for Adjudications in

Materials and Operator Licensing Proceedings'' for suspension and

termination decisions, in lieu of the hearing procedures detailed in

the internal procedures published with this Notice for suspension and

termination of an agreement, sections V and VI, respectively.

The staff is soliciting comments from the Agreement States and the

public at this informal stage by publishing the documents and also

placing them in the Nuclear Regulatory Commission's Public Document

Room located at 2120 L Street, NW. (Lower Level), Washington, DC.

Comment period expires October 4, 1994. Comments received after this

date will be considered if it if practical to do so, but the Commission

is able to assure consideration only for comments received on or before

this date. Mail written comments to: Secretary, U.S. Nuclear Regulatory

Commission, Washington, D.C. 20555, Attention: Docketing and Services

Branch. Deliver comments to: 11555 Rockville Pike, Rockville, Maryland,

between 7:45 am and 4:15 pm on Federal workdays. For further

information contact Ms. Maria Lopez-Otin, Federal Liaison, Office of

State Programs, U.S. Nuclear Regulatory Commission, Washington, DC

20555, telephone (301) 504-2598. Once the comments are received, the

staff will develop a final draft of the policy statement for Commission

review. After obtaining Commission approval, the proposed policy

statement will once again be issued for a final round of public

comment.

Two other policy statements continue to be applicable, in large

part, but future revisions to these existing policy statements will be

necessary to reflect the new ``umbrella'' policy statement. The two

existing policy statements are: ``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) and ``NRC Review of Agreement State

Radiation Control Programs, Final General Statement of Policy'' (57 FR

22495; May 28, 1992).

This draft statement of policy does not contain a new or amended

information collection requirement subject to the Paperwork Reduction

Act of 1980 (434 U.S.C. 3501 et seq.).

Dated at Rockville, Maryland this 29th day of July, 1994.

For the Nuclear Regulatory Commission.

John C. Hoyle,

Acting Secretary of the Commission.

I. Purpose

The purpose of this Statement of Principles and Policy 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) to 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) guide post-agreement

interactions to ensure that NRC and Agreement State radiation control

programs are coordinated and compatible and that Agreement State

programs continue to ensure adequate protection of the public health

and safety.

This policy statement establishes principles, objectives, and goals

that should be reflected in the implementing guidance and programs of

the NRC and Agreement States to meet their respective program

responsibilities and which should be achieved in the administration of

these programs.

II. 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 the 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 for many years been borne 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

relinquish to the States its regulatory authority over the use of these

materials. 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, the

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 the public health and

safety. In addition, the Commission has an obligation 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 the

public health and safety or 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 hearing. In addition,

the Commission may temporarily suspend all or part of an agreement in

the case of an emergency situation.

III. Principles of Program Implementation

III.1. Regulatory Program Excellence

The principles of excellence contained in this section provide a

common philosophical basis on which Agreement States and NRC regulatory

programs should be formulated and implemented. NRC and the Agreement

States should strive for excellence in the administration of their

programs and in their collective efforts to establish a credible,

coherent, consistent program for the regulation of Atomic Energy Act

materials throughout the United States. Both the NRC and the Agreement

States should continually improve their regulatory program

effectiveness and efficiency based on their respective and collective

experience. Excellence in radiation safety regulation should include

striving to improve assurance of the adequacy of public health and

safety. In order to achieve excellence, the highest standards of public

accountability, ethical conduct, and professionalism should be applied

to individual and organizational performance.

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, and appear to be, independent and

impartial in its actions and free from pressure and inappropriate

influences from the regulated community. 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 should be documented with

the rationale for such decisions explained. 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, or appropriate, to assure

safety, and should be clear, coherent, logical, and practical.

Regulatory actions should be fully consistent with regulations 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 excellence 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.

There is an obligation by all involved to identify and express concerns

relating to a program that appears to be operating contrary to these

principles of excellence.

It is not intended that these principles of excellence 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 materials program

managers and staff in the self assessment of their programs and to use

in the establishment of goals and objectives for the continual

improvement of their respective programs. However, in the normal

conduct of NRC Region and Agreement State formal program performance

reviews, any deficiencies that indicate the program is not adhering to

these principles of excellence should be noted.

III.2. Coherent National Program

NRC acknowledges its responsibility to ensure that there is a

coherent national radiation control program and NRC through this

program establishes national radiation protection standards. The basic

elements of such a program include ability to ensure adequate

protection of the 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 excellence in program administration.

Each of these elements is reflected and addressed in specific

sections of this policy statement.

III.3. Adequate to Protect the Public Health and Safety

NRC and Agreement State radiation control programs share a

responsibility to ensure adequate protection of the public health and

safety in the administration of their respective regulatory programs

controlling the uses of nuclear materials and facilities. 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 the

public health and safety.

III.4. Compatible in Areas of National Interest

NRC and Agreement State radiation control programs share a

responsibility to ensure that a consistent and compatible radiation

control program is administered. Such a radiation protection program

should be based on a common regulatory philosophy including use of

common definitions and standards. It should not only be 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. 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 national radiation control program. States will

not have the flexibility to deviate from the program elements that the

Commission requires for compatibility.

III.5. Flexibility

With the exception of national radiation protection standards, to

the extent possible, Agreement State radiation control programs 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 bar or 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 requirements provided that the

requirements for adequacy are still met, and the more stringent

requirements do not preclude or effectively preclude a practice within

the national interest without an adequate public health and safety or

environmental basis.

IV. New Agreements

IV.1. Overall Process of Becoming an Agreement State

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 the public health and safety with

respect to the materials within the State covered by the proposed

agreement and compatible with the Commission's program. This

certification will be provided in a letter to the NRC which 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.

IV.2. Phased Implementation

The NRC believes that a formal phased implementation process,

during which a State initially assumes authority over smaller, less

complex licenses, would be advantageous to both NRC and the Agreement

State. It would provide the NRC an opportunity to obtain important

information on the State's program and validation of the State's

capabilities before turning over a major portion of the program. At the

end of the initial phase, the NRC would have greater confidence in the

State's ability to protect the public health and safety and to

administratively manage the program. From the State perspective, it

should provide new States an opportunity to work out start up problems

with their program prior to having responsibility for more complex

licenses.

Therefore, upon the effective date of a full agreement, a mandatory

phased implementation process will be used. In the initial phase, the

State will assume full regulatory authority over categories of

licensees programs of lesser complexity. During this phase, the State

will perform all regulatory functions for the transferred licenses. At

the end of this phase, the NRC will evaluate the State program to

determine that the State program continues to be adequate to protect

public health and safety and compatible with the Commission's program.

If, at the end of the initial implementation phase, the Agreement State

program is adequate and compatible, and the State has demonstrated an

ability to assume authority for more complex licensed activities, the

remaining categories of licensees will be transferred to the State.

V. Mutual Program Assistance

NRC will provide 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

during transition periods of assumption of regulatory authority.

Following assumption of regulatory authority, NRC will continue to

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. Similarly,

Agreement States will assist the NRC and other Agreement States in

addressing areas where Agreement States have particular expertise or

are in the best position to provide immediate assistance. In addition,

NRC and Agreement States shall use their best efforts to 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 will 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 Agreement State programs, regulations,

policies, and regulatory guidance.

Following assumption of regulatory authority by an Agreement State,

if it experiences difficulty in program administration, NRC 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 the public health and safety.

VI. Performance Evaluation

Under Section 274 of the Atomic Energy Act of 1954, as amended, NRC

retains authority for ensuring that Agreement State programs continue

to provide adequate protection of the 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. NRC, 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 safety control programs and identification of

areas needing improvement.

As a part of this performance evaluation process, NRC will take any

necessary actions to ensure that Agreement State radiation control

programs remain adequate and compatible. These actions include: (1)

biennial 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; (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 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 the 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 which jeopardize the State's ability

to continue to ensure adequate protection of the public health and

safety. The basis for NRC's actions will be based on a well defined and

predictable process and a performance evaluation program which will be

consistently and fairly applied.

VII. 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 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 the 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.

Finding 2--Marginally Adequate1

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 marginally adequate. 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 marginally adequate.

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\1\Since the compatibility finding is made on the basis of a

State having program elements which are ``identical'', ``essentially

identical'', or ``essentially verbatim'', there can be no

intermediate finding between compatible and not compatible. In terms

of the compatibility evaluation, and the need for possible NRC

action, the significance of an individual element in a State program

will be judged on the basis of its impact on the national radiation

protection program.

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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 the public health and safety. If the

NRC determines that a State, after a substantial period of time, has

either failed to adopt a significant item(s) of compatibility or has

failed to adopt several of the required compatibility items, or has

refused to revise state regulations which are inconsistent with the

required NRC compatibility elements, the program would be found not

compatible.

VIII. 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. None of these actions

are automatic. 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. In the

case where minor deficiencies are noted, the State would be requested

to describe their proposed corrective action. If the corrective action

appears appropriate, no further NRC review 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 which can lead to a marginally

adequate 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 either a

significant item(s) of compatibility or has not adopted several of the

required compatibility elements. 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 the public health and safety. In some cases, 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 the public health and safety, or if

the State has not complied with one or more of the requirements 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 due to a lack of confidence in the State's

ability to protect the public health and safety, the Commission would

suspend all or part of its agreement with the State. 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 the public health and safety, or if the State

program has not complied with one or more of the requirements 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.

IX. Program Funding

NRC will continue to provide training and other assistance to

Agreement States to the extent permitted by statute and budgetary

resources. Currently, Section 274 does not allow federal funding for

the administration of Agreement State radiation control programs.

Section 274 does authorize the NRC to offer training and other

assistance to a State in anticipation of entering into an Agreement

with NRC, however, it is NRC practice not to fund the establishment of

new Agreement State programs.

Given the importance in terms of protection of the public health

and safety to have a uniform national program of well trained radiation

control program personnel, the NRC intends to continue funding training

and travel for Agreement State staff. NRC staff would also provide

technical assistance to Agreement States to address complex licensing

and compliance issues and other specialized technical assistance.

X. 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 the 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 (i.e., 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.

XI. Program Evolution

The NRC-Agreement State program is dynamic and the NRC and

Agreement States will continue to jointly assess the overall national

program to identify specific changes which should be considered based

on experience or to further improve overall performance and

effectiveness of the national program. The changes considered should

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.

Specific Review Area Recommendations

Whether two separate policies, one for entering into an

agreement and one for evaluation of existing state programs, are

needed.

The PAG has considered this issue and recommends that a single

``umbrella'' policy covering the NRC and Agreement State Program be

issued. The existing policy statements that address entering into an

Agreement and the evaluation of State programs will be modified or

converted to procedures.

Evaluation of whether a formal transition period should be

established during which new Agreement State programs could be phased

gradually.

The PAG recommendation, which includes a formal transition period

for new Agreement State programs, has been incorporated as section IV

of the draft Policy Statement.

Reevaluation of the criteria and elements used for

adequacy and compatibility reviews so that the less significant items

are eliminated and the focus is on those things which must be complied

with to provide reasonable assurance of adequate protection of the

public health and safety.

The new compatibility policy and criteria are being developed. The

pilot program under the Integrated Materials Performance Evaluation

Program (IMPEP) will consist of gathering information on the common

performance indicators in addition to the normal program reviews.

Criteria for adequacy are contained in the IMPEP procedures. The PAG

will maintain cognizance of these initiatives and serve as an

integrative mechanism.

Identification of the information which NRC needs from the

Agreement States and establishment of a requirement for the reporting

of such information. In addition, why this information is needed and

how it benefits health and safety.

The PAG review of existing Agreements between the NRC and Agreement

States found that the Agreements contain a commitment for the Agreement

State and the NRC to use their best efforts to keep each other informed

on regulatory changes to assure that the State and Commission programs

are coordinated and compatible. Currently, representatives of the

Agreement States and NRC staff in AEOD, OSP, and NMSS are evaluating

options for the development of a database on events involving Atomic

Energy Act-regulated materials. The database is intended to provide

Agreement State and NRC staffs with information to assist in the

evaluation of regulatory effectiveness, and aid in the prediction of

safety trends.

The PAG will consider the current initiatives to obtain information

on events in conjunction with its examination of the merits of

codifying State agreement practices in a new part of the NRC rules and

regulations, including the need to codify a requirement for reporting

of event data by Agreement States. The PAG will factor in the

information derived from these initiatives when it examines the

codification issue.

Identification of the minimum administrative-type

provisions the NRC will consider necessary in assessing the adequacy

and compatibility of Agreement State programs. This covers such things

as: hearing opportunities, rulemaking procedures, environmental

assessments, the separation of regulatory and promotional

responsibilities, investigative capabilities, enforcement policies,

criminal sanctions, and other similar provisions.

In establishing compatibility criteria, the staff will address

these issues. IMPEP is also considering a number of these areas. The

PAG will maintain cognizance of these initiatives and serve as an

integrative mechanism.

Evaluation of the present practice of placing Agreement

State approved devices on the NRC registration list so that they can be

used nationwide.

OSP, NMSS, and OGC are evaluating the current practice and will

provide recommendations to the Commission describing approaches which

will result in improved effectiveness and efficiency in sealed source

and device reviews.

Review and make appropriate recommendations on the

adequacy of the documentation and control procedures currently being

used by the NRC for the Agreement State program.

Although Commission regulations do not specifically impose data

reporting requirements on Agreement States, the NRC criteria for the

approval of new programs and the periodic review of existing State

programs, necessitate that a State provide sufficient documentation to

the NRC for the evaluation of the program. In addition to the

documentation needed for the NRC to evaluate a State program against

the NRC approval or review criteria, existing State programs routinely

submit a wide variety of information and documentation, including

copies of licenses and orders issued by the State, statistical data on

licensing and inspection activities, draft and proposed regulations,

copies of sealed source and device registrations, licensing guides, and