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National Materials Program

Options and

Recommendations

Final Report of the Working Group

SECY 99-250

Volume I

May 2001
National Materials Program

Working Group Report

examines

* impacts of increasing number of Agreement States

* six options for a National Materials Program structure

and

* the following six issues as specified in SECY-99-250

Development of an overall program mission statement with defined

top level goals and objectives.

Delineation of the respective roles and legal responsibilities of

NRC and the Agreement States, including the Organization of

Agreement States and the Conference of Radiation Control

Program Directors, Inc.

Delineation of the scope of activities to be covered by the program

and the need for statutory changes at both state and federal levels.

Establishment of formal program coordination mechanisms.

Establishment of performance indicators and a program assessment

process to both measure program performance and to ensure

program evolution.

Provision/budgeting of resources at both state and federal levels.
lll

National Materials Program

Working Group Members

Kathy Allen, Co-Chair

Jim Myers, Co-Chair

Fred Combs, Advisor

Carol Abbott

Chip Cameron

Cindy Cardwell

Joe DeCicco

Elizabeth Drinnon

Tom Hill

Linda Howell

Jake Jacobi

Bob Walker

Duncan White

Illinois Department of Nuclear Safety

U.S. Nuclear Regulatory Commission

U.S. Nuclear Regulatory Commission

U.S. Nuclear Regulatory Commission

U.S. Nuclear Regulatory Commission

Texas Department of Health

U.S. Nuclear Regulatory Commission

Georgia Department of Natural Resources

Georgia Department of Natural Resources

U.S. Nuclear Regulatory Commission, Region IV

Colorado Department of Public Health and

Environment

Massachusetts Department of Public Health

U.S. Nuclear Regulatory Commission, Region I

Special Assistance From:

Charlie Cox

Jim Lieberman

Hampton Newsome

Brooke Poole

U.S. Nuclear Regulatory Commission

U.S. Nuclear Regulatory Commission

U.S. Nuclear Regulatory Commission

U.S. Nuclear Regulatory Commission

Steering Committee Members

Carl Paperiello, Chair

Edgar Bailey

Douglas Collins

Donald Cool

Jesse Funches

Joseph Gray

Robert Hallisey

William Kane

Paul Lohaus

Cynthia Pederson

Martin Virgilio*

U.S. Nuclear Regulatory Commission

California Department of Health Services

U.S. Nuclear Regulatory Commission, Region 11

U.S. Nuclear Regulatory Commission

U.S. Nuclear Regulatory Commission

U.S. Nuclear Regulatory Commission

Massachusetts Department of Public Health

U.S. Nuclear Regulatory Commission

U.S. Nuclear Regulatory Commission

U.S. Nuclear Regulatory Commission, Region Ill

U.S. Nuclear Regulatory Commission

(*replaced William Kane)
iv

Acknowledgments

First, we wish to thank the families of the Working Group members for their support.

Without it this project would not have been successful. This project required a lot of

travel and a lot ofyourfamily member's personal time, late at night and on weekends,

away from you. We truly appreciate your sacrifice and the many special arrangements

you made to allow us to complete this report.

We also thank the members of the Working Group for their vision, insight and

dedication to this project. From the very beginning, you recognized the scale and

importance of the project and setforth to complete it on time. You gave your best and

characteristically, our meetings were full of enthusiasm and synergy. The Co-Chairs

thank you foryour effort and contribution.

The National Materials Program Working Group would like to thank the states of

Colorado, Georgia, Illinois, Massachusetts and Texas, and the Nuclear Regulatory

Commission's (NRC's) Office of State and Tribal Programs, Office of Nuclear

Material Safety and Safeguards, Office of General Council, Office of Chief Financial

Officer, and Regions I and IVfor allowing their staff the time to participate in this

important effort. We also thank the NRCfor thefunding to support travel of the

working group members and especially Brenda Usilton, who processed the travel

vouchers.

The states of Colorado, Georgia, Illinois, South Carolina, NRC Regions III and IV,

and NRC Headquarters staff hosted our meetings. Because this was a large Working

Group with a complex task, our meeting needs were often complicated. Your hosting of

our meetings was a big help. Your contributions made our meetings successful.

We thank the Conference of Radiation Control Program Directors, Inc., the

Organization ofAgreement States, and the New England Radiological Health

Committee for providing time during your annual meetings for the Working Group to

discuss its efforts and obtain comments and suggestions. These organizations

recognize the importance of the role of the states in a National Materials Program and

have been very supportive of the Working Group's efforts.
V

Acknowledgments - continued

We sincerely appreciate the suggestions and comments we received from licensees,

consultants, non-government organizations, states, co-workers and other stakeholders

during tabletop exercises, public meetings, and outreach sessions. We appreciate the

work done by the Health Physics Society in providing information about the project to

its members via their Newsletter and at local Health Physics Society chapter meetings.

The Working Group would like to thank the Steering Committee for its comments and

guidance. We have done our best to incorporate your perspective on the project.

Bob Moody, Sherri Miotla, and Cathy Colleli of NRC's Inspector General's office

receive our thanks for their objective review of the working group's process,

preliminary work and draft report. Your concise comments were especially valuable

and improved the quality of our report.

We are especially blessed to have Margaret Henderson, Texas Department of Health,

as our editor. Margaret took our draft text and turned it into a beautiful, easy to read,

document. She has, thanks to her special talents, made us "look good." Thanks,

Margaret!

A special note of thanks also goes to Jim Drinnon, Georgia, for his assistance in using

the relative value decision matrix, and to Ann Frescura of Illinois for the Working

Group logo design.

* *

Kathy Allen, Co-Chair Jim Myers, Co-Chair
Vi

Executive Summary

In November 1999, NRC Commissioners approved the staff plan (SECY-99-250) to

form a working group to address the impacts of the increased number of Agreement

States and to provide advice to the NRC on the "National Materials Program."

Currently, 32 Agreement States regulate approximately 16,500 radioactive materials

licensees and NRC regulates approximately 5,000 licensees. As the number of

Agreement States continues to increase, the number of licensees under NRC

jurisdiction will continue to decrease. This trend has resulted in:

• shifting expertise from NRC to Agreement States

* decreasing numbers of licensees to support NRC's infrastructure

* increasing likelihood that new technologies will emerge in an Agreement State,

rather than in an area under NRC jurisdiction

The National Materials Program Working Group, consisting of six representatives from

states and six NRC representatives and an NRC advisor, first met in early 2000. The

Steering Committee consisted of nine senior NRC managers and two Agreement State

program directors.

Because there is no clear definition of a "National Materials Program," the Working

Group defined the attributes of a national program. SECY-99-250 directed the Working

Group to address the following six issues:

1. Development of an overall program mission statement with defined top level goals

and objectives.

2. Delineation of the respective roles and legal responsibilities of NRC and the

Agreement States, including Organization of Agreement States and Conference of

Radiation Control Program Directors, Inc.

3. Delineation of the scope of activities to be covered by the program and the need for

statutory changes at both state and federal levels.

4. Establishment of formal program coordination mechanisms.

5. Establishment of performance indicators and a program assessment process to both

measure program performance and to ensure program evolution.

6. Provision/budgeting of resources at both state and federal levels.
Vii

Executive Summary-cont'd

The Working Group defined its mission to "develop options for the Commission's

consideration for creating a National Materials Program that will implement the following philosophy:

To create a true partnership of the NRC and the States that will ensure

protection of public health and safety and the environment..."

The Working Group's mission and philosophy is consistent with NRC's Strategic Goals

and Objectives.

The Working Group then identified the program elements necessary for a National

Materials Program. These included, but were not limited to, elements such as licensing and inspection programs, rule and guidance development, and mechanisms for

communicating with stakeholders. The current methods for implementing various

program elements were defined and alternatives identified. These alternatives were

evaluated against the current methods using the following objectives:

* Optimize resources of federal, state, professional, and industrial organizations * Account for individual agency needs and abilities

* Promote consensus on regulatory priorities

* Promote consistent exchange of information

* Harmonize regulatory approaches

* Recognize state and federal needs for flexibility

Once basic program elements were identified, the Working Group developed options for

a National Materials Program. After defining the current national regulatory program, five other options were developed and discussed. Options ranged from allowing all

states to independently regulate all radioactive materials without federal oversight to

having only one regulatory entity with jurisdiction over all radioactive material in the

United States.

The Working Group sought input from stakeholders at several meetings, and conducted

a tabletop exercise at the October 2000 Organization of Agreement States meeting to

test a consensus-based national program. One of the comments repeated at various

meetings with stakeholders reflected the need to have a leadership presence at the

national level.
viii

Executive Summary-cont'd

After evaluating comments from stakeholders, considering the advantages and

disadvantages for each of the structural options, and the potential resource implications

for each option, the National Materials Program Working Group recommends that the

Commission adopt the Alliance Option, a cooperative, consensus process for a National

Materials Program. The Alliance serves as a basis for achieving NRC's current

strategic goals and objectives, as well as the future goals and objectives of a National

Materials Program. The Alliance offers the prospect of leveraging NRC's program by

joining in a continuing collaborative process with other regulators. The process would

jointly establish national priorities and agendas, share resources, and develop common

regulatory products. Implementation of the Alliance Option will assist NRC by

continuing its presence in a National Materials Program, as its share of licensees

nationwide decreases.

An Implementation Plan should also be developed and used to ensure that the

Commission's directions regarding a National Materials Program are fully enacted.

In addition to the structure for a National Materials Program, the Working Group

identified several enhancements that could be used with or without changes to the

national program. Regardless of which option the Commission selects, NRC should

encourage the use of Centers of Expertise to supplement its abilities and should

continue its role in maintaining an information infrastructure. In addition, NRC should

create a Standing Compatibility Committee to ensure consistency of compatibility

determinations for all rules. Finally, NRC should seek authority to regulate discrete

naturally-occurring or accelerator produced radioactive material in order to ensure

national consistency in the regulation of all radioactive material.
ix

Table of Contents

Volume One

National Materials Program ....................

Working Group Members ....................

Steering Committee Members ................

.................... iii .

..................... iii

....................... 

Acknowledgments................................................. iv

Executive Summary ..................................... . vi

SECTION I....................................

Relationships Between NRC and States .........

Figure 1.1 - Active Materials Licensees . .

Relationships of Regulatory Programs ...........

National Materials Program - Current Approaches

Comparison of Three Approaches ...............

Coordinating Organizations ....................

.................... .1.1

.................... .1.2

.................... .1.2

.................... .1.3

.................... 1.4

.................... 1.5

.................... 1.6

Conference of Radiation Control Program Directors, Inc.............

Organization of Agreement States ...............................

Future Challenges for a National Materials Program ...................

Resources Budgeted for Materials Regulation ........................

Figure 1.2 - 2001 Resource Data ...........................

Effects of an Increasing Number of Agreement States on NRC Resources

Figure 1.3 - Current NRC Resource Structure ................

Figure 1.4 - Impact of New Agreement States

on NRC Resources ......................................

. 1.6

. 1.8

. 1.9

1.10

1.11

1.12

1.13

1.13

SECTION II ................................. 2.1

Mission and Philosophy of the Working Group ........................ 2.2

Goals of the NRC ............ .......................... 2.3

Goals of the Working Group ...................................... 2.4

Process to Develop and Evaluate Options ............... .............. 2.5

Essential Program Elements ...................................... 2.6

Enhancements to Existing Program Elements ......... ................ 2.7

Common Themes ............. ......................... 2.8

Sharing of Resources . ...................................... 2.9

Stakeholder Outreach - NRC's Process ............ ................. 2.10

Stakeholder Outreach - Communication Plan ........................ 2.11

Stakeholder Outreach - Opportunities ................ I.............. 2.13

Stakeholder Outreach - Tabletop Exercise ...

Stakeholder Outreach - Public Meeting .

........................ .2.14

........................ .2.15
x

Table of Contents

Volume One

SECTION III ...........................................

Options for a National Materials Program ..................

Comparison of Options .................................

Current Program ....................................

Figure 3.1 - NRC Resources for Current Program .

Independent States .................................

Figure 3. 2 NRC Resources for Current Program

and Independent States Option ................

Minimum NRC Involvement ...........................

Figure 3.3 - NRC Resources for Current Program

and Minimum NRC Involvement ...............

Alliance ...........................................

Figure 3.4 - NRC Resources for Current Program

and Alliance Option .........................

Alliance Makeup and Structure .....................

Delegated Program ..................................

Figure 3.5 - NRC Resources for Current Program

and Delegated Program ......................

Single Regulatory Agency ............................

Figure 3.6 - NRC Resources for Current Program

and Single Regulatory Entity ..................

3.1 

........

3.4 

3.6 

...... 

...... 

...... 

...... 

............. 3.29

............. 3.31

............. 3.36

............. 3.38

3.46 

............. 3.52

............. 3.54

............. 3.59

SECTION IV .....................................................

Recommendations for a National Materials Program ................

The Alliance as a National Materials Program ......................

Relative Value Decision Matrix ..................................

Figure 4.1 - Evaluation of National Materials Program Options

Costs Savings with the Alliance Option ...........................

Assumptions Regarding the Alliance Option .......................

Recommendations for a National Materials Program ................

SECTION V .....................................................

Use Centers of Expertise .......................................

Seek Authority to Regulate NARM ...............................

Maintain an Information Infrastructure ............................

Create a Standing Compatibility Committee .......................

SECTION VI .....................................................

Responses to SECY-99-250 Directives ............................

... 4.1

... 4.2

... 4.3

... 4.4

... 4.4

... 4.5

... 4.6

... 4.7

... 5.1

... 5.2

... 5.3

... 5.5

... 5.6

6... 1.

... 6.2
1.1

SECTION I

In Section 1, the Working Group considers the impact of the increasing

number of Agreement States. The Group examines the current materials

program and the relationships between NRC and states. The section

presents the history, current status, and future challenges of the program.

Current models and voluntary organizations are examined with specific

details about the contributions of the Conference of Radiation Control

Program Directors and Organization of Agreement States. The impact of

the increasing number of Agreement States on resources of NRC and

Agreement States is estimated.
1.2

Relationships Between NRC and States

History, Current Status, and Future Challenges

History, current models, future challenges, and relationships between NRC and

states were considered in developing options for a National Materials Program

History

In 1959, Section

274 was added to

the Atomic Energy

Act

Section 274(g). of the Atomic

Energy Act, authorizes and

directs the Nuclear Regulatory

Commission..."to cooperate

with the States in the

formulation of standards for

protection against hazards of

radiation to assure that State

and Commission programs for

protection against hazards of

radiation will be coordinated

and compatible."

This was the culmination of

early efforts by the U.S.

Congress, states, federal

officials, and other

organizations to coordinate

the regulation of radiation.

The tradition of cooperative regulation of radioactive

materials originated over 40 years ago. Relationships and

cooperation between the Atomic Energy Commission (AEC)

and the states were formally defined by federal statute when

the Atomic Energy Act (AEA) was amended with Section

274. These relationships have evolved over time.

Currently, 32 states have signed formal agreements with the

Nuclear Regulatory Commission (NRC) or its predecessor,

the AEC, and regulate radioactive materials as "Agreement

States." The historical progression of state and federal

relationships is shown on page 1.3. Figure 1.1 shows the

change in the number of NRC and Agreement State licenses

over time.

Figure 1.1-Active Materials Licensees

1800o

16000

14000

CO

° 12000 r

a)

_ 10000

16

8000 0 

6000

4000 T1965 1970 1975 1980 1985 1990 1995 2000

Year

NRC licensees .. , Agreement State Licensees
1.3

Relationships of Regulatory Programs

NRC and states have a long history of cooperation.

1950s Relationships and cooperation began between AEC and the states. AEC

recognized the need to consult with the states on emerging radiation safety

issues. A few states were regulating some radioactive materials prior to the

addition of Section 274 to the AEA.

1955 AEC Director of Operations formed an advisory committee of state officials to

advise AEC regarding federal/state relations. The committee's work continued

for a period of time after enactment of Section 274 and the committee was later

disbanded in the mid to late 1960s.

1959 Section 274 was added to the AEA. The purpose of Section 274 was, in part:

1. to recognize the interests of the states in the peaceful uses of atomic energy

2. to clarify the respective responsibilities of the states and the Commission

under AEA with respect to the regulation of byproduct, source, and special

nuclear materials

3. to recognize the need for and establish programs for cooperation between

the states and the Commission

4. to promote an orderly regulatory pattern between the states and the

Commission

5. to provide a mechanism for discontinuance of certain Commission authority

and state assumption of authority for activities involving byproduct, source,

and specified quantities of special nuclear material

6. to recognize that additional legislation may be desirable as the states

improve their capabilities to effectively regulate such materials

7. to authorize and direct the Commission to cooperate with the states in the

formulation of standards for protection against radiation hazards

1962 Kentucky became the first Agreement State and assumed responsibility for

regulating AEA material (byproduct, source and specified quantities of special

nuclear material) within its borders.

1971 The number of Agreement State licensees exceeded the number of AEC

licensees.

1975 The Nuclear Regulatory Commission was formed.

2000 The number of Agreement States grew to 32.
1.4

National Materials Program - Current Approaches

Multiple governmental systems perform regulatory functions for the academic,

medical, and industrial use of radioactive materials.

Multiple

approaches....

*NRC

* Agreement States

* Non-Agreement

States

* Other Regulatory

Agencies

Through combined authority and

resources, this network of

organizations addresses the

regulation of:

1. radioactive material,

including AEA materials,

NARM (naturally-occurring or

accelerator produced

material)

2. radiation produced by

machines (x-ray)

3. nonionizing radiation

Current Status

Governmental systems that perform regulatory functions in

the United States reside in federal and state programs. They

are:

1. NRC - The federal agency that regulates use of

byproduct, source, and special nuclear material in nonAgreement States and U.S. territories, by federal entities,

and in areas of exclusive federal jurisdiction.

2. Agreement States - State governments that have signed

agreements with NRC to regulate AEA material within

their respective jurisdictions, with exception of activities

exclusive to NRC or those specified in their agreements.

The Agreement States also regulate NARM and

machine-produced radiation (accelerators and x-ray

equipment).

3. Non-Agreement States - State governments that have

not signed agreements with NRC, but can regulate

NARM. Most non-Agreement States also regulate

machine-produced radiation.

4. Other Regulatory Agencies -The Department of

Energy has its own set of standards for sites under its

jurisdiction. The Environmental Protection Agency has

air and water emissions standards that may differ from

NRC rules. The Occupational Safety and Health

Administration and the Department of Transportation

both have requirements for handling, using, or

transporting radioactive material. The Food and Drug

Administration regulates mammography and evaluates

drugs and devices used in medicine.

No national program

comprehensively

covers the full

spectrum of radiation

which is regulated for

the purposes of health

and safety in the

United States.
1.5

Comparison of Three Approaches

NRC, Agreement States, and non-Agreement States have different approaches and

responsibilities.

Agreement States

States promulgate rules, policies,

and procedures to implement and

manage their programs, respond to

incidents and events, issue licenses,

and conduct inspections.

Most Agreement States conduct

sealed source and device

evaluations that are documented in

NRC's database; however, a few

Agreement States have chosen not

to perform these evaluations.

Agreement States must maintain

programs that are adequate to

protect public health and safety.

Byproduct, source, and special

nuclear material rules are required

to be compatible with NRC rules, as

determined during NRC's

rulemaking process.

Some Agreement State and NRC

program functions must be

compatible.

Non-Agreement States

Non-Agreement States can regulate

NARM and machine-produced

radiation as required by state

statutes.

Nuclear Regulatory Commission

NRC exercises regulatory jurisdiction over AEA materials

in non-Agreement States. In Agreement States, NRC retains

authority over federal agencies, production and utilization

facilities, export and import activities, disposal in the

oceans, high level waste handling and disposal, transfer of

materials to persons exempt from licensing (consumer

products), large quantities of special nuclear material, offshore waters, certain aspects of mill tailings management,

and certain activities conducted within some Agreement

States, as specified in the respective agreements. NRC also

maintains an oversight function for determining adequacy

and compatibility of Agreement State programs.

NRC interfaces with federal agencies and Congress about

the nationwide materials program.

NRC maintains the lead in establishing priorities and policy

for developing rules and standards for the use of AEA

material for the nation. NRC responds to incidents and

events, issues licenses, conducts sealed source and device

evaluations, and conducts inspections of its licensees.

NRC also reviews certain transportation packaging, issues

exempt distribution licenses, and maintains national

databases for:

* sealed source and device certificates issued by NRC and

states

* incidents and events reported by NRC and Agreement

State licensees

* certificates of compliance issued for transportation

packages

NRC is the primary contact for most incidents and events

that cross regional and Agreement State boundaries, and

also provides technical assistance to states for event

response when needed.
1.6

Coordinating Organizations

Conference of Radiation Control Program Directors, Inc., and Organization ofAgreement

States facilitate coordination of radiation control activities.

The Conference of Radiation Control Program Directors, Inc. (CRCPD), is a voluntary

professional organization whose primary membership is made up of individuals in state and local

government who regulate the use of radiation sources. Other members include individuals with an

interest in radiation protection.

CRCPD was established in 1968 and its membership is open

to representatives from all state, local, and federal

governments who regulate and control the use of sources of

radiation. Individuals, regardless of employer affiliation,

.a1 \who have expressed an interest in radiation protection may

join. CRCPD also has international members.

CRCPD is directed by a seven-member Board of Directors,

whose membership is elected from state radiation control

SSRCRs help to establish personnel. Day-to-day operations of the organization are

consistency in radiation administered by the Executive Director and staff who are

rules. Stakeholders have employees of the organization.

stated that variations in rules

between states leads to CRCPD sponsors committees that write and publish

confusion for the regulated Suggested State Regulations for Control of Radiation

community, particularly for (SSRCRs), making them available for use by the states.

those licensees who have Other CRCPD committees research technical issues,

operations in several develop guidance documents, and prepare background

Agreement and non- information for SSRCR committees. A CRCPD committee

Agreement States. also reviews applications from states requesting Licensing

State status.

SSRCRs provide a tool to aid states in development of rules that are consistent across the nation. Both

Agreement and non-Agreement States use SSRCRs published by CRCPD as a guide to writing state

rules. These suggested rules include NRC's compatibility determinations. NRC participates with states

in the development of SSRCRs for radioactive materials. This effort is consistent with purposes

specified in Section 274 of the AEA. Despite the compatibility requirements determined by NRC and

the efforts of CRCPD to establish consistency in radiation protection standards nationwide, differences

exist due to varying state laws. These differences have not led to a decrease in public health and safety.
1.7

Coordinating Organizations - cont'd

Conference of Radiation Control Program Directors, Inc., and Organization of

Agreement States facilitate coordination of radiation control activities.

Licensing State Status

CRCPD may confer Licensing State status to

Licensing States states. To become a Licensing State, a state

are those states promulgates rules and procedures for control of

radiation hazards for non-AEA materials that are that have been similar to those rules and procedures used by NRC,

designated by the other Agreement States, or other Licensing States.

CRCPD pursuant Licensing State status assures other states that

to criteria found in licensees and/or sources and devices are subject to

Publication 94-8 equivalent licensing practices with respect to

"CRCPD discrete sources of NARM, including an adequate i of quality control program. Vendors in a Licensing Recognition of State may be granted reciprocal recognition of their

Licensing States license or acceptance of their product. Upon the

for the Regulation recommendation of the CRCPD Licensing State

and Control of committee, CRCPD confers Licensing State status.

NARM."

Currently, no non-Agreement States are recognized

as Licensing States. This creates a potential

problem because some non-Agreement States

allow companies to produce and distribute NARM

products to users in other states. In those

situations, there is no guarantee that quality

assurance programs that control the manufacturing

and distribution of such products have been

approved by any licensing authority.
1.8

Coordinating Organizations - cont'd

Conference of Radiation Control Program Directors, Inc., and Organization of

Agreement States facilitate coordination of radiation control activities.

Organization of Agreement States (OAS)

OAS is a voluntary organization of individuals from

! &Agreement States. Its primary purpose is to provide a

( °mechanism - for Agreement States to work with each

S other and with NRC on regulatory issues associated

with the agreements.

Organization of Agreement States

The AEC and Agreement States began holding annual

meetings in 1964. In 1971, when states chose to meet

separately from AEC for about half a day during these

meetings, OAS began to develop. States elected a

chairman whose main tasks were to organize the state

portion of the meeting and send a letter with

recommendations to the Director of the Office of State

' p r Programs. The current Executive Board includes the

QAS's primary chair, chair-elect, past chair, secretary and secretarypurpose is to elect. These positions are held by Agreement State

provide a forum representatives.

for Agreement

States to work Prior to the 1990s, NRC set the agenda for these

together and meetings and funded travel costs for Agreement State t Rrepresentatives' attendance. During the 1990s, NRC with NRC. funding ceased and Agreement States began funding

their attendance at the meetings. This change also

resulted in the Agreement States taking a more active

role in determining the meeting agendas. Today, OAS

determines the agenda with input from NRC. The OAS

Executive Board and NRC have monthly conference

calls during which participants discuss the status of

activities of interest. In addition, the OAS Executive

Board and the CRCPD Chair brief the Commission

annually.
1.9

Future Challenges for a National Materials Program

NRC and Agreement States must create a structure to accommodate shifting licensee

populations and regulatory expertise.

32 Agreement

States are

responsible for

75% of the total

licensees and by

FY 2003 that

number is

expected to

increase to over

80%.

Changing Status of Agreement State and NRC

Programs

At the present time, NRC exercises regulatory

responsibility over approximately 5,000 materials

licensees, and the 32 Agreement States regulate

approximately 16,500 materials licensees. NRC staff

expects three additional states to become Agreement

States by FY 2003 and estimates that the number of NRC

licensees will drop to approximately 4,000. At that time,

the Agreement States will be regulating about 17,500

licenses. This continuing shift in licensee population,

both in number and type of radioactive material user, has

the following implications:

$ the shift in expertise for certain types of licenses from

NRC to the states could affect NRC's ability to

effectively regulate that technology

$ NRC may find it more difficult to maintain a

regulatory infrastructure with a decreasing number of

licensees

/ the decreasing number of NRC licensees increases the

licensee fee burden

/ increased state experience in regulating AEA and

non-AEA sources of radiation is shifting expertise to

the Agreement States

/ new technologies are more likely to emerge in an

Agreement State than in an NRC-regulated

jurisdiction

The continuing shift in

licensee population has

implications for both NRC

and Agreement State

programs.

To develop and maintain the infrastructure of rules and

supporting guidance, NRC will need to use a process that

reflects this shift.
1.10

Resources Budgeted for Materials Regulation

Assumptions were necessary to compare NRC and state resources.

Comparison:

FTE per 100

specific

licenses

States -

2.0 to 3.2 FTE

NRC - 3.0 FTE

NRC and Agreement State Resources

Resources currently budgeted by states and NRC in materials

programs were compared using NRC FY 2001 materials

budgeted resources. Differences in how NRC and the states

prepare and report on budget items, as well as the scope of

the programs, required the Working Group to make

assumptions in order to compare the number of full time

equivalent (FTh) NRC and state positions per 100 licenses.

Assumption: Scope of Programs

Differences in the scope of programs have an impact on

resources. Certain assumptions were made in order to

compare similar efforts. For example, low-level waste and

uranium recovery resources were omitted because they are

not common to all states. NRC Site Decommissioning

Management Plan resources were omitted because the states

do not individually have the legacy of these sites. Also,

NRC maintenance of the national infrastructure was not

included in the comparison.

The Working Group considered separating resources

associated with the regulation of discrete NARM from the

materials license totals for the individual states. However, it

decided to include NARM totals for these reasons:

1. An infrastructure already exists in terms of

licensing/inspection. Therefore, the Working Group

concluded that, outside of start-up costs for NRC, regulation

of NARM was not a significant resource issue.

State and NRC resources are

compared in terms of FTE per

100 licensees. Resource data in

Figure 1.2 on the following

page shows a range of program

sizes and are reported in:

* full time equivalent

positions (FTE)

* numbers of specific

licensees

2. Agreement States do not differentiate between AEA

materials and NARM when licensing and inspecting. The

resource implications for licenses with both NARM and AEA

materials would be insignificant because the radiological

hazards associated are similar.

NOTE: State personnel from Agreement and non-Agreement States indicated that most licensees have both AEA material and

NARM. A majority of licensees with only NARM appears to be associated with sealed sources of low activity. For example,

New Jersey, a non-Agreement State, has 382 NARM licensees. Approximately 230 of these licensees also have NRC licenses

for AEA material. Approximately 100 of the remaining NARM-only licenses authorize the use of sealed sources in x-ray

fluorescence and lead paint analyzers that are of minor radiological significance. The remaining approximately 50 licensees

would require regulatory attention similar to that for AEA material licensees.
1.11

Reference Table

-1

Figure 1.2 - 2001 Resource Data

State/NRC Specific licenses* FTE FTE/100 Specific Licenses

Rhode Island 63 1.9 3.0

Maine 129 2.75 2.1

Colorado 312 6.2 2.0

Georgia 481 11 2.3

Massachusetts 524 17 3.2

Illinois 740 20 2.7

Texas 1480 42 2.8

NRC 5000 149 3.0

* State numbers include specific licenses for NARM.

Notes:

1. Illinois, Colorado, Texas, and NRC resources are approximate and do not include 11 .e.(2) byproduct

material or low-level radioactive waste programs.

2. Georgia and Illinois resources do not include environmental monitoring and emergency response

program costs.

3. Resources do not include corporate overhead (e.g., indirect FTE).

Note that the range in FTE/1 00 licenses for states and NRC reflect the emphasis or challenges

unique to a program, the distribution in the type of materials licensees, and each agency's

budgeting process. For example, the Massachusetts program has several staff members assigned

to the evaluation of sealed sources and devices due to the concentration of manufacturers in the

Commonwealth.
1.12

Effects of an Increasing Number of Agreement States on

NRC Resources

Currently, NRC must maintain a national materials infrastructure regardless of the

number of NRC licensees.

As the number of Agreement States increases, the NRC license base decreases. To evaluate the impact

of this change, the Working Group used the NRC FY 2001 budget in the Materials Arena. Because the

NRC budget is not organized in terms of those program elements subject to agreements under Section

274, the Working Group eliminated those activities that are not impacted by the agreements (fuel cycle

activities and support for spent nuclear fuel) and added resources from the 2001 budget in areas which

were determined to be common to NRC and Agreement State materials programs (low-level waste and

uranium recovery activities). The Working Group also included resources to maintain the framework for

materials regulation and those NRC efforts to support the materials program. The additions are

represented in the left column, "Analysis of Impacts Includes:" below.

In order to more accurately predict the manner in which NRC resources would vary under conditions of a

changing licensee base, the Working Group divided the NRC resources into two groups, those which can

reasonably be expected to change in a linear fashion with the number of licensees and those whose

change is more complicated. These directly variable and indirectly variable resources are defined below.

This concept was also used when evaluating the resource implications of options in Section III.

Analysis of Impacts Includes:

* decommissioning

* low-level waste

* uranium recovery

* direct support of materials activities,

including

-legal

-enforcement

-event assessment

-investigations

-research

-state and tribal programs

* indirect support of materials activities,

including

-financial

-administrative

-information technology infrastructure

-personnel

-physical plant

Directly Variable Resources and Indirectly

Variable Resources

As used in evaluation, directly variable resources are

those NRC resources that change directly as the number

of NRC licensees change (e.g., FTE dedicated to

licensing, inspection, etc.).

Indirectly variable resources are those NRC resources

that are dependent on program or policy decisions and

are not necessarily directly affected by the number of

NRC licensees. Indirectly variable resources also

represent regulatory activities particular to NRC's

oversight role and implementation of the current

materials program.

When both directly and indirectly variable resources are

combined, NRC has a total resource of 336 FTE in FY

2001 or 6.7 FTE per 100 licenses. Projected for FY

2004, the total FTE will be 316 or 7.9 per 100 licenses.

Figures 1.3 and 1.4 provide a summary of resources and

impacts data.
1.13

Reference Tables

Figure 1.3 depicts the current NRC resource structure. Figure 1.4 depicts the projected change in NRC

resources for directly and indirectly variable resources under the existing materials program if NRC

policies and program activities implementing those policies do not change as the anticipated number of

NRC licensees decreases. Decreases in NRC licensees are predicted to result from the addition of three

new Agreement States by FY 2004.

Figure 1.3 - Current NRC Resource Structure

Activity Directly Variable FTE Indirectly Variable FTE Total

NMSS, Regions 71 126 197

Direct Support* 27 36 63

Agency Overhead** 0 76 76

Total 98 238 336

* These resources include Office of State and Tribal Programs, Materials Research, Incident Response,

Enforcement, Investigations, Legal Advice, and Adjudications.

** These include indirect resources providing policy, financial, administrative, information technology

infrastructure, personnel support, and physical plant support.

Figure 1.4 - Impacts of New Agreement States on NRC Resources

FY 2001 FY 2004***

Number of NRC Licensees 5000 4000

Number of Agreement States 32 35

NRC Indirectly Variable 238 238

resources (FTE)

NRC Directly Variable 98 78

Resources (FTE)

Total NRC Resources (FTE) 336 316

FTE/100 Licensees 6.7  7.9** **

* ** This data was not part of the FY 2002 budget review process, but those resources for FY 2004 will be

identified by the respective offices in this year's FY 2003 budget formulation effort.

**** These numbers reflect total resources for the NRC that includes overhead and support resources for the

materials program.
2.1

SECTION 11

In Section 11, the Working Group describes the process it used to examine

options for a National Materials Program. The Working Group adopted a

mission, philosophy, process, and criteria for evaluating options and

conducted stakeholder outreach.
2.2

Mission and Philosophy of the Working Group

The Working Group adopted a mission statement that incorporates a philosophy

used in evaluating options.

Fundamental Background

goal: The Working Group recognized that optimizing the use of state

and federal resources and accommodating differing regulatory

Resources priorities would be important for state and federal agencies

should be applied working within the framework of a National Materials

to a common Program.

agenda of Currently, the materials program is largely directed by NRC,

mutually agreed- which establishes regulatory priorities for byproduct, source,

upon goals and and special nuclear materials. Although Agreement States

objectives. enjoy a participatory arrangement with NRC in some areas

(e.g., rulemaking, use of working groups, etc.) under the

current process, little consideration is given to Agreement State

Examples of regulatory priorities that would include, in addition to AEA

duplication... materials, NARM, x-ray and accelerator generated radiation,

- several states have and non-ionizing radiation hazards/sources.

independently

developed guidance Both NRC and Agreement States expend resources in an effort

for positron emission

tomography to accommodate differing priorities. Often, regulatory agencies

- industrial resolve the same issues independently, which results in a

radiography rules duplication of efforts and resources. Resources should be

were adopted by applied to a common agenda of mutually agreed-upon goals

states, then NRC. and objectives. With this in mind, the Working Group

This required many developed this mission statement, "The mission is to develop

states to make options for the Commission's consideration for creating a

conforming changes national materials program that will implement the following

solely for compatibility philosophy:..."

purposes.

Philosophy

To create a true partnership of the NRC and the States that

will ensure protection of public health, safety, and the environment while:

optimizing resources of federal, state, professional and industrial organizations

accounting for individual agency needs and abilities

promoting consensus on regulatory priorities

promoting consistent exchange of information

harmonizing regulatory approaches

recognizing state and federal needs for flexibility
2.3

Goals of the NRC

The NRC strategic and performance goals were incorporated in criteria

developed by the Working Group for evaluating potential options.

The Working Group incorporated NRC's strategic and performance goals as discussed below.

Maintain safet& by establishing a regulatory oversight framework that ensures that materials

licensees continue to conduct activities involving use of radioactive materials and radiation

sources in a safe manner. Maintaining regulatory programs that are adequate to protect public health and safety is a priority in evaluating potential changes.

Improve the effectiveness and efficiency of regulatorev rograms nationwide by enhancing

collaboration through exchange of information and resources, promoting consensus among regulatory agencies, and optimizing use of resources on a national level. A national program should seek to balance use of resources among the states and NRC and distribute the resource

burden more equitably among Agreement State and NRC licensees. A national program should

also account for individual or unique program needs and provide flexibility, which may be

needed to expand or modify existing regulatory programs to ensure adequate oversight of unique

or emerging technologies.

Enhance public confidence by 1) increasing consistency and predictability in regulatory

approaches, while recognizing the need for flexibility among state and federal regulatory

programs, and 2) improving efficiency in implementing our regulatory oversight responsibilities.

Reduce unnecessary regulatory burden by promoting a consistent regulatory approach

nationwide which will offer efficiencies for licensees and greater predictability for stakeholders.
2.4

Goals of the Working Group

The Working Group identified several objectives that were used to guide its

efforts in developing recommendations for a National Materials Program

1. Optimize resources of

federal, state,

professional, and

industrial organizations

2. Account for individual

agency needs and

abilities

3. Promote consensus

on regulatory priorities

4. Promote consistent

exchange of information

5. Harmonize regulatory

approaches

6. Recognize state and

federal needs for

flexibility

NRC Strategic Plan, Goals and Missions of

Agreement States

The primary goal of maintaining public health and

safety was consistent among NRC and state programs,

although other goals identified in the various strategic

plans and mission statements were not consistent

throughout. They were however, generally compatible.

Based on this examination, the Working Group

identified six objectives that were used to guide its

efforts in evaluating options and developing

recommendations for a National Materials Program.

These objectives incorporate the NRC's strategic goals

and are reflected in the Working Group's philosophy

statement on page 2.2.
2.5

Process to Develop and Evaluate Options

The Working Group developed and evaluated options for a National Materials

Program

Process

The Working Group initially examined the NRC

Strategic Plan and strategic goals or mission

statements established by some Agreement

States. Based on this information, the Working

Group decided to:

Boffom-Up 1. focus on creating a functional, rather than

Approach... programmatic structure by identifying

outcomes (e.g., protection of public health)

identify what is and outputs (e.g., rules and guidance),

needed in terms neededf o o n mes o2. use a bottom-up approach by looking at of outcomes or basic program elements common to all

outputs rather radiation control programs and evaluating than immediately methods to accomplish those tasks.

defining

relationships or Functional Structure

processes The Working Group focused on evaluating between NRC relationships and processes that could be used

and states by the Agreement States and NRC to achieve

specific outcomes rather than initially creating

new organizational structures.

Bottom-Up Approach

The Working Group wanted to identify what

was needed in terms of outcomes or outputs

rather than immediately defining the

relationships or processes required to be formed

between and used by NRC and Agreement

States. The Working Group first determined

what a National Materials Program should do to

achieve or maintain state and federal strategic

goals. This method was followed rather than

using a top-down approach by immediately

defining a framework for a National Materials

Program.
2.6

Essential Program Elements

The Working Group began by defining essential program elements for the National

Materials Program

Essential program elements

program The Working Group began by defining essential program

elements elements for a National Materials Program. The elements were

derived from... taken from Criteriafor an Adequate Radiation Control

Program, April 1999, CRCPD Publication 99-2, and from NRC

Management Directive 5.6, Integrated Materials Performance Criteria for an Evaluation Program. These defined the program elements to be

Adequate evaluated.

Radiation

Control For each program element, the Working Group identified the current methods used by Agreement States and NRC to Program, April accomplish the program element; then the group brain stormed

1999, and alternative methods for accomplishing each program element.

NRC The alternatives were initially assessed to ensure they supported

the primary, common strategic goal of maintaining health and

Management safety. If an alternative was not consistent with this primary

Directive 5.6, goal, it was eliminated from further evaluation.

Integrated

Materials Alternatives for

Performance each program

Evaluation element are

Program described in detail

in Appendix C.

Evaluating Options: Alternatives for each program element were compared to current practices,

considering the six objectives of the Working Group. The alternatives were rated as being equal to,

better than, or worse than the current practice. For example, each alternative for issuing materials

licenses was rated with regard to optimizing resources offederal and state agencies, and professional

and industrial organizations. The alternative was then rated against the existing practice for each of

the remaining criteria. Based on the evaluation results, a preferred alternative, or "enhancement,"

was made for each program element. For some elements, the enhancement was the status quo, for

some it was a new way of doing business, andfor others it was a combination of alternatives.
2.7

Enhancements to Existing Program Elements

The Working Group identified multiple enhancements that could be made to the

existing methods for accomplishing these program elements.

Enhancements

Licensing and Inspection

Guidance

Performing Inspections

Performing Licensing

Rule and Guidance

Development

Training, Qualifications,

and Experience Standards

* NRC and Agreement States jointly develop an agenda and

priorities for developing licensing and inspection guidance.

* Use working groups to develop guidance.

* Accept consensus standards (following review and

revision, if needed).

* Contract with other organizations to develop guidance

when appropriate.

* Allow licensees to perform self-audits that may be

accepted in lieu of inspection by NRC or an Agreement State.

* Allow other entities to contract with NRC and Agreement

States to perform inspections and report results to the

appropriate regulatory agency.

* Accept audits performed by other organizations and use

these as a supplement to NRC and Agreement State

inspections.

* Use "Centers of Expertise" (see page 2.9) to perform

inspections of specific technical areas.

* Use contracted entities to perform some license reviews or

portions of reviews for specific technical areas.

* Use Centers of Expertise to perform some license reviews

or portions of reviews for specific technical areas.

* Jointly establish agenda and priorities.

* Use working groups or Centers of Expertise.

* Promote development of consensus standards.

* Contract with other organizations for technical support.

* Use a clearinghouse of training ideas, resources, and

opportunities designed for or employed by NRC and

Agreement States.

* Allow licensees to provide training.

* Contract with licensees to train staff in specific technical

areas.

* Encourage a regulatory agency exchange program to

develop staff in specific technical areas.
2.8

Common Themes

After reviewing the evaluations ofprogram elements, six common themes or

attributes were identified.

Consensus process - Decisions concerning regulatory goals

and framework should be made through a process involving

both Agreement States and NRC in which general agreement

is reached through a cooperative effort.

Consensus Jointly establishing regulatory priorities - Regulatory does not priorities should be set with common goals in mind.

Agreement States and NRC should jointly, through a

necessarily consensus process, determine regulatory priorities (research,

mean rulemaking, guidance development, etc.). The schedule or

unanimity, but plan for achieving those priorities and the best use of resources to accomplish those priorities should be implies general coordinated.

agreement and

provides an Recognition of current successes - Agreement States and

opportunity for NRC have individual regulatory successes as well as successful efforts that are cooperative. Some program all parties to elements are working successfully as they now exist. Many

bring issues, current practices could be more successful with modifications

ideas, and or when enhanced with alternatives.

concerns to the Recognition of individual legal and jurisdictional issues -

table for Despite the need for consistency and cooperation, there will

consideration. be situations in which Agreement States and NRC have

unique legal or jurisdictional obligations that must be met.

These specific obligations must not be impeded by a National

Materials Program.

Shared Responsibility - Several structural options for a

National Materials Program that are discussed in Section III,

if fully implemented, would require more uniform resource

commitment among the states and NRC.

Sharing of Resources - For a National Materials Program to

be successful, all materials regulatory programs must

participate. Participation means a commitment of resources,

such as staff time or financial support.
2.9

Sharing of Resources

The Working Group identified several methods for sharing of resources.

Identify and use Centers of Expertise within the

existing regulatory community

Some Agreement States and NRC regions have, over

time, developed considerable experience and expertise

with specific uses of radioactive materials. Examples of

areas of expertise include well logging, industrial

radiography, positron emission tomography, and

Reduce duplicate intravascular brachytherapy. Agreement States and

efforts... NRC regions that have developed expertise in specific

uses should be identified and used as a resource by other

The concepts regulatory programs. These "Centers of Expertise " may

discussed under change over time as others develop expertise.

"Sharing of

Resources" will assist Use alternative resources where possible

regulatory programs When appropriate, alternative resources should be used

to reduce duplicative in conjunction with or in place of the current regulatory efforts and save methods. Alternative resources can include consensus

resources. standards or enlisting the resources and cooperation of

professional and industry organizations.

Establish an information infrastructure

A centralized "clearinghouse" of regulatory products

should be established for use by Agreement States and

NRC staffs. This could serve as a centralized source of

information on the availability of rules, guidance

documents, industry and professional standards, etc.,

and could facilitate dissemination of information.
2.10

Stakeholder Outreach - NRC's Process

The Working Group examined the current NRC stakeholder outreach process.

As part of its process, the Working Group conducted stakeholder outreach to gain comments about the

Working Group's process and possible options for a National Materials Program. The Working Group

began by examining the NRC stakeholder outreach process.

NRC's Stakeholder Outreach Process

Regulatory decisions NRC decides when to begin rulemaking or develop policy or

must be informed guidance and informs other entities that the process will begin.

decisions-- it is NRC solicits voluntary input from Agreement States and other

necessary to actively stakeholders. Not all stakeholders choose to participate. The

seek and consider input Commission evaluates all input appropriate in making

from those persons who decisions. The Commission also sets priorities and decides

would be affected. compatibility on the issues under development.

In addition to consulting with Agreement States and other

stakeholders, the Commission uses advisory committees, such

Input from other federal as the Advisory Committee on Nuclear Waste and the Advisory

and state agencies Committee on Medical Uses of Isotopes. These advisory

(Environmental Protection committees are independent and autonomous from the

Agency, Department of Commission; they recommend priorities or actions that they

Energy, and equivalent feel the Commission should take. The Commission may accept

state environmental or or reject advisory committee recommendations.

health agencies) charged

with regulating radiation The Commission contracts with various organizations for

issues is sought. research when members believe it necessary or advisable in

developing rules and guidance. This research furthers the

effectiveness and efficiency of the Commission and the

Other stakeholders Agreement States in performing their regulatory functions.

include..

- licensees The other federal and state agencies are considered

- public stakeholders because at this time, the effort towards - professional establishing a National Materials Program is being driven by

organizations the NRC and representatives from the state radiation regulatory

- industry organizations agencies. It is envisioned that many of the stakeholders, i.e.,

- other federal and state other federal and state agencies and professional and industrial

agencies with an interest organizations, could become participants in the National

in radiation issues Materials Program in the future.
2.11

Stakeholder Outreach - Communication Plan

The Working Group sought stakeholder involvement in evaluating the options for a

National Materials Program

Stakeholder Outreach

Outreach Methods...

- Electronic Communications

- Written Communications

- Tabletop Exercise

- Public Meeting

- Focus Groups

The Working Group developed a communication plan

(see Appendix B) to guide its approach in delivering its

key messages and engaging the various stakeholder

groups. The plan identified overall objectives,

stakeholders, communication tools and opportunities,

and key messages.

The Working Group provided information to various

stakeholder groups on the development of the options for

a National Materials Program. To obtain feedback, the

Working Group used electronic and written

communications, conducted counterpart and professional

society meetings, tested a pilot project, met with NRC

senior management, and held a public meeting.

Many stakeholders expressed satisfaction with current

practices and offered suggestions that the Working

Group considered in evaluating options for a National

Materials Program.

A summary of the

Working Group

Outreach Activities

is in Appendix B.
2.12

Stakeholder Outreach - Communication Plan - cont'd

Electronic and written communications were important to the Working Group's

outreach efforts.

Electronic Communications

An important component of the Working Group's

Outreach outreach efforts was the establishment of an Internet site

publications... at the beginning of the process. The Working Group

used the site to provide access for stakeholders to its

Internet information during the development phase of the options for a National Materials Program. The Internet

site was also used to announce all Working Group

Federal meetings. List servers focusing on radiation issues for

Register state and federal regulators were also used to solicit

input during product development and to obtain

Health Physics information on specific issues.

Newsletter Written Communications The Working Group published notices in the Federal

Register announcing its initial meeting in March 2000

CRCPD and the public meeting in February 2001. All other

Newsletter meetings were posted at the Working Group's Internet

site

Three articles on the National Materials Program

appeared in the November 2000 Health Physics Society

Newsletter. One of the Working Group's Co-chairs and

the Chair of the Working Group Steering Committee

were interviewed. The articles discussed the current

regulation of radioactive material in the United States

and the pros and cons of regulation by Agreement States

or the NRC. These articles were available to the health

physics community (regulatory and non-regulatory

stakeholders) nationwide. Articles on the activities of

the Working Group also appeared in the CRCPD and

NRC Office of Nuclear Material Safety and Safeguards

newsletters.
2.13

Stakeholder Outreach - Opportunities

The Working Group provided many opportunities for stakeholders to participate.

May 2000

Presented a poster at the annual CRCPD meeting

in Tampa, Florida. The poster session

introduced the mission and planned activities of

the Working Group to state radiation program

managers and staff.

July 2000

Provided information on the current status and

activities at a meeting of standards development

organizations.

July through November 2000

Provided information on the current status and

activities of the Working Group to materials

staff at each of the four NRC regions and at

NRC Headquarters.

October 2000

Presentation and table-top exercise at the annual

OAS meeting in Charleston, South Carolina.

November 2000

Provided information on the current status and

activities of the Working Group at the annual

New England Radiological Health Committee

meeting in Mystic, Connecticut. The meeting is

attended by the staff and management of the six

New England states and regional federal

representatives from the Food and Drug

Administration, Environmental Protection

Agency, Federal Emergency Management

Agency, NRC, and Canada.

January 2001

Presented information to the regulated

community in Georgia at a meeting of the

Atlanta Chapter of the Health Physics Society.

February 2001

The Working Group held a public meeting in

Arlington, Texas, to discuss the various options

for a National Materials Program. The Working

Group obtained feedback from a focus group of

individuals who represented a wide spectrum of

regulatory and non-regulatory stakeholders.

After a presentation on the options described in

Section III of this paper, the Working Group

facilitated a discussion using a set of questions

to obtain feedback and comments.

March 2001

Presented information to the regulated

community at a meeting of the New Jersey

Chapter of the Health Physics Society.

April 2001

Presented update on the status of the Working

Group activities at the annual CRCPD meeting

in Anchorage, Alaska.

Presented information to the regulated

community in Texas at a meeting of the South

Texas Chapter of the Health Physics Society. A

focus group session was held after the

presentation to obtain feedback on specific

questions.
2.14

Stakeholder Outreach - Tabletop Exercise

A tabletop exercise provided an opportunity to apply some of the National Materials

Program concepts and obtain feedback

Consensus Building with Tabletop Exercise

On October 2 and 3, 2000, the Working Group held Participants brought a tabletop exercises for consensus building on determining

list of their three top the agenda for regulatory priorities at the annual OAS regulatory priorities meeting. In addition, the Working Group gave a

over the next 7 to 28 presentation on the current status and activities of the months. Working Group.

The priorities were Prior to the OAS meeting, the Working Group requested consolidated into a that each Agreement State and NRC bring a list of their

single list. three top priorities over the next 7 to 28 months in the

e .n areas of regulations and guidance development. The The partcipants priorities for each state and NRC were collected and

re ahed conses. consolidated into a single list. Copies of the on the priorities, consolidated list were given to each agency participant.

A group of states Working Group members facilitated an exercise with the

decided to pool their participants to reach consensus on the priorities provided

resources to work on by each agency.

one of the priorities. A priority item identified by a number of states was the

need for licensing guidance for positron emission

tomography (PET). The Working Group considered the

tabletop exercise a success because, as a result of this

exercise, a group of states led by the State of

Washington decided to pool their resources and develop

the necessary PET licensing guide.

The interaction, discussion, and action taken on the PET

licensing guidance was an important event for the

Working Group in terms of stakeholder outreach because

it was an opportunity to have stakeholders apply some of

the National Materials Program concepts and obtain

their feedback. Continuing feedback to the Working

Group has been positive and development of PET

guidance is ongoing.
2.15

Stakeholder Outreach - Public Meeting

Options for a National Materials Program were discussed during a public meeting.

A public meeting was held February 21 and 22, 2001,

in Arlington, Texas, to discuss the various options for a

National Materials Program and obtain feedback from

a focus group of individuals representing a wide

spectrum of regulatory and non-regulatory

Feedback from public stakeholders. The stakeholders included representative

meeting... from NRC, Agreement States, non-Agreement States,

licensees, professional societies, environmental groups,

* federal agencies should other non-governmental organizations, and

stop creating conflicting organizations representing specific categories of

standards licensees.

NRC should regulate For each potential National Materials Program option,

discrete NARM the focus group participants discussed how it impacted

* Some entity should be "in the following:

charge" of a National - access to decision makers

Materials Program - budget/resource implications

* NRC should be willing to - legal authority

modify the AEA - efficiency

* a National Materials - uniformity/consistency

Program should improve - flexibility

consistency, but allow - comprehensiveness

flexibility - stability

- role of NRC, Agreement States, and other

organizations

- rationale for change

- accountability

- practicality

The focus group participants recognized that there are

options within each option for a National Materials

Program and, in some situations, options can be

combined. Input from the participants helped the

Working Group define the options for a National

Materials Program that are outlined in Section III.
3.1

SECTION III

In Section 111, the Working Group discusses six options for a National

Materials Program structure. The options were developed through

discussions with and comments from stakeholders and reflect the

combined expertise of the Working Group members.

Section III begins with a brief description of each option followed by a table

comparing the six options. Next a written comparison summarizes some

key considerations. Following the summary, each option is discussed in

depth, starting with the Current Program, which is used as the base case

for comparison, and continuing through the range of options.
3.2

Options for a National Materials Program

Options for a National Materials Program were examined by the Working Group after

considering discussions with and comments from stakeholders. In this report, the following six options were evaluated, beginning with the current program, which is used as a base case.

1. Current Program

2. Independent States

3. Minimum NRC Involvement

4. Alliance

Current NRC and Agreement State programs remain in

effect. No policy changes are involved. This is the "Base

Case" used by the Working Group for comparison of the

other options.

NRC has jurisdiction over federal facilities, areas of

exclusive federal jurisdiction, and over certain quantities of

special nuclear material. NRC does not provide regulatory oversight of materials programs. "Agreement States" as

such do not exist; however, states could regulate materials

based on state needs and priorities.

NRC may reduce efforts and resources from the current

level to a minimal program by making changes to policies concerning implementation of program elements. States

continue to become Agreement States and NRC maintains

oversight function. Certain elements of a radiation

protection program, such as performing inspections, are

not directly specified in the AEA, but are necessary to

protect public health and safety.

Current NRC and Agreement State programs continue, but

work to develop national regulatory priorities and products in a collaborative manner. Decisions are based on group

consensus. Agreement States assume greater responsibility for decisions and for devoting resources to

develop regulatory products.

5. Delegated Program

6. Single Regulatory Agency

State Agreements as they exist today would cease. NRC

develops rules and maintains authority over all licensing and inspection functions. NRC may authorize states to

implement the licensing and inspection portion of the

program under contract to NRC. Authority is delegated to

the state for the term of the contract or agreement.

Regulatory authority over radioactive materials nationwide

is the responsibility of a single federal entity. This entity could be NRC, the Environmental Protection Agency, the

Food and Drug Administration, or some new entity responsible for regulating all radioactive material.
3.3

Options for a National Materials Program

The Working Group considered the current regulatory program structure and a range

of other options.

The Working Group included the current regulatory program in evaluating options for a National Materials Program

as a base case. The Working Group also considered extremes to bound its assessment. For example, "Independent

States" eliminates NRC oversight and most of its involvement in materials regulation. Conversely, "Single

Regulatory Agency" eliminates state authority for radioactive materials regulation.

Comparison of Options Table

Current Independent Minimum Alliance Delegated Single

Program States NRC Program Regulatory

(Base Case) Involvement Agency

Change in AEA No Yes No Yes Yes Yes

required (Agreements) (NARM) (Agreements (Agreements

and NARM) and NARM)

Agreement States Yes No Yes Yes No No

# of Agreement States 32 0 32 32/50 0 0

Assumed

NRC jurisdiction over Yes Yes Yes Yes Yes Yes

federal facilities

No. of state programs 32 50 32 32/50 0 0

possible

No. of states where 18 0 18 18/0 50 50

NRC has jurisdiction

NRC licensing Yes Yes Yes Yes Yes Yes

NRC physical Yes Yes Policy Yes Yes Yes

inspection Dependent

Guidance Yes Yes Policy Yes Yes Yes

development Dependent

Rule development Yes Yes Yes Yes Yes Yes

Evaluation of state Yes No Yes Yes Yes Yes

regulatory programs

IMPEP Yes No No Yes No No

Estimated NRC $55(336) $3.7(23) min. support 32 states - $76(368) $113(744)

resources in millions $36.7(269) $51.6(315)/

and (FTE) min. program 50 states -

$32.0(200) $24.7(135)
3'.4

Comparison of Options

The Working Group compared and contrasted various attributes of the six options

detailed in this report.

In contrast to the Current Program, the NRC would probably not support a national radioactive materials program

in the Minimum NRC Involvement Option. This option considered NRC regulating only AEA material and

continuing a voluntary Agreement State program with 32 states. Under this scenario, NRC would retain

approximately five thousand licensees, would resemble a very large Agreement State and would maintain only

minimum oversight of the Agreement States. In the Minimum NRC Involvement Option, NRC would be

involved in inspections and guidance development to a limited degree. Because the AEA does not require the

review of Agreement States to be as comprehensive as the current IMPEP, NRC would discontinue its use of the

IMPEP. The Working Group recognizes the limitations of this option, but it was included to illustrate the impact

of policy decisions on resources.

In contrast to the above option, the Alliance Option reflects an evolution of the Current Program and offers many

enhancements to the current regulatory programs of both NRC and the Agreement States. The Alliance Option

includes the collaborative development of regulatory products (rules and guidance) to enhance the development of

a consistent national program. Agreement States, industry and other stakeholders could participate more fully by

jointly setting national priorities and agendas. More resources and people would be shared among all agencies to

accomplish the common goals, as defined by the national priorities and agenda, while protecting public health and

safety and providing the maximum flexibility when meeting those national goals and priorities. Although IMPEP

would be retained in the Alliance, it is possible that it may be changed to reflect new performance indicators

required under a National Materials Program.

The three remaining options considered would require changes to the AEA if they were to be implemented. In the

Independent States Option, a change in the AEA would abolish NRC's materials program for non-federal

entities. NRC would not conduct any state oversight. Some states would need to modify their legislation to

assume authority over AEA material and may need to adopt a radioactive materials program similar to the program

conducted by Agreement States today. Some states may not choose to support a radioactive materials program,

and this would create a regulatory gap for AEA materials nationally. The Working Group included this as an

extreme to bound the options, though the group determined that it does not meet the mandatory goal of protecting

public health and safety. It is possible that states would maintain a voluntary version of the IMPEP. However,

without national performance standards, or a mechanism for assuring compliance, the Working Group believes

that the IMPEP program would survive only as a set of voluntary guidelines.
-3.5

Comparison of Options - cont'd

The Working Group compared and contrasted various attributes of the six options detailed in

this report.

Another option requiring a change to the AEA would be the Delegated Program. This program would abolish the

Agreement States program, leaving the entire regulatory program to be run by NRC. This program is envisioned

to be similar to the current FDA delegated programs for mammography. Input from stakeholders at the meeting in

Arlington, Texas revealed many problems associated with the operation of a delegated program. While many

problems can be overcome, the effort to abolish the current program and reconstitute a delegated program across

50 states would be very challenging from cost, organizational and political perspectives. Considerable effort

would be expended to change the AEA, abrogate existing agreements, set up a delegated program, negotiate the

terms of a delegated program with each state, and to set up a policing function to assure consistency across the

delegations. It is possible that a modified form of IMPEP could be retained; however, the Working Group

observes that this process would probably be prescriptive and not performance based. In the Working Group's analysis, this option would consume resources at a rate almost equal to that of the Single Regulatory Agency

Option.

The third option requiring a change to the AEA is the Single Regulatory Agency for AEA material. This would

be a reversion to the regulatory program for AEA material of the early 1 960's. A change in the AEA would

abolish the Agreement State Program and NRC would resume regulation of all byproduct material. A modified

IMPEP could be continued on a regional basis; however, the number of regions cannot be estimated. Conceivably,

there could be one region for each state (50), or at least a region in larger states and some consolidation of groups of smaller states. When considering this option, the Commission would need to account for reconstituting a large training program to prepare the number of staff necessary to administer such a large centralized program. In

general, changes to statutes (of either NRC or Agreement States), costs, time, effort, and effect to the AEA would

need to be considered.

Under the Single Regulatory Agency Option, NRC resources are projected to increase to absorb work currently

conducted under Agreement State programs. This option is inconsistent with the present trend where the federal

government is transferring responsibility for all, or parts, of its programs to the states. It also appears to provide

the least degree of public confidence as it seeks little input from affected stakeholders and would not accommodate

state views.

The following portions of this Section describe each option in more detail.
3.6

Current Program

NRC and 32 Agreement States regulate AEA materials. NRC has leadership

responsibility for AEA material and certain oversight functions over Agreement States.

The 32 Agreement States and the 18 non-Agreement States have jurisdiction over NARM.

What are the roles/responsibilities of NRC is responsible for regulation of AEA materials, licensing,

the NRC for each program element? inspection, rule promulgation, guidance development,

incident/allegation investigation, and Agreement State oversight. NRC

also has regulatory responsibility for federal entities, areas of exclusive

federal jurisdiction and materials subject to international safeguards.

What are the roles/responsibilities of States have authority for regulation of all radioactive material, licensing,

Agreement States for each program inspection, rule promulgation, guidance development, and

element? incident/allegation investigation.

Are statutory changes required? No.

What coordination is required? Coordination exists between the NRC and states individually or through

the OAS and CRCPD.

What resources are needed (federal Each regulator provides workforce and financial resources to perform

and state)? their respective legislative mandates. On joint projects, the NRC pays

per diem and travel and states pay salaries and provide time away from

Who would pay? routine work.

Accountability NRC is accountable to Congress, licensees, and public. Agreement States

are accountable to State legislative and executive branches of their

respective governments, licensees and the public. Agreement States are

subject to NRC oversight.

Program Assessment Agreement States, NRC Regional Offices, and Headquarters sealed source

and device (SS&D) evaluation program are periodically reviewed using the

IMPEP process.

Program Gaps NARM is not regulated uniformly, if at all, in non-Agreement States and

at federal facilities.
3.7

Current Program

Advantages Disadvantages

The Current Program functions in a

semi-consultative/advisory way, with

NRC assuming a strong leadership

role. Section 274 of the AEA

emphasized cooperation between

NRC and Agreement States. NRC

sets standards, determines

compatibility for these standards and

evaluated adequacy and compatibility

of Agreement State programs. The

Current Program has established a

high nationwide standard for radiation

protection for AEA materials.

Agreement States apply these

standards to non-AEA materials they

regulate.

No mandate exists in a consultative/advisory

relationship for NRC to accept solicited

advice, whether it comes from the states,

licensees or other stakeholders. The Current

Program is not an equal partnership between

NRC and Agreement States. Historically, the

Current Program has not encouraged NRC to

identify and use expertise from states nor has

it provided a means for NRC and states to

jointly establish a national regulatory agenda.

The Current Program creates duplication of

efforts. For example, in Agreement States,

licensees that distribute devices to persons

who are exempt from licensing must obtain

two licenses:

* one from the NRC to distribute devices

* one from the Agreement State to possess

radioactive material

Another duplication occurs in writing

regulatory guidance. Rules currently are

drafted a minimum of three times:

* by NRC

* by CRCPD as a Suggested State

Regulation

* by each Agreement State according to its

own administrative procedures
3.8

Current Program

1. Roles and Responsibilities of NRC and States for Each Program Element

A. Performing Materials Licensing (including Sealed Source and Device Reviews, Lowlevel Radioactive Waste, Uranium Recovery, and Decommissioning)

States

Agreement States license

byproduct, source and

special nuclear material in

certain quantities, as well as

NARM.

Specific licenses are issued.

Mechanisms used in specific

licensing are reasonably

consistent among the states.

However, mechanisms for

general licenses and the

level of communication and

contact with general

licensees varies widely

among Agreement States.

Most Agreement States also

have SS&D evaluation

programs that include

NARM.

The licensed waste disposal

facilities in the United States

are located in and regulated

by the Agreement States of

South Carolina, Washington,

and Utah.

NRC

NRC licenses:

* AEA materials in non-Agreement States

* activities at most federal facilities

* distribution of radioactive devices to persons

exempt from licensing

* use and possession of special nuclear material

greater than certain quantities

* disposal at sea of byproduct, source and special

nuclear materials

* import and export of AEA materials

NRC regions evaluate and issue license for byproduct,

source and special nuclear materials. NRC issues specific

licenses. NRC uses different mechanisms with General

Licensees.

NRC conducts SS&D evaluation program and the exempt

distribution program from NRC headquarters office.

NRC does not currently regulate a low-level radioactive

waste licensee. NRC does maintain a minimal program that

supports 10 CFR Part 61 and provides input to the

Commission on policy matters.
3.9

Current Program

A. Performing Materials Licensing (including Sealed Source and Device Reviews, Lowlevel Radioactive Waste, Uranium Recovery, and Decommissioning) - cont'd

States

Currently only four

Agreement States,

Colorado, Texas, Illinois and

Washington, have regulatory

programs for uranium mining

and milling.

Decommissioning licensed

facilities in Agreement

States is generally an

integral part of their licensing

and inspection programs.

NRC

NRC licenses and inspects uranium recovery facilities in

non-Agreement States. NRC also makes final determination

on site closures for uranium recovery facilities in all states.

NRC ensures the decommissioning of licensed facilities in

accordance with its rules and guidance for formerly licensed

sites, the Site Decommissioning Management Plan (SDMP). Decommissioning licensed facilities is performed by NRC

licensing and inspection programs. NRC has recently

implemented a grant program to Agreement States. Grants

will fund evaluation of the remaining formerly licensed

AEC/NRC licensees within a state's jurisdiction.
3.10

Current Program

B. Performing Materials Inspections

States

Agreement States inspect

facilities located in their

jurisdictions using

procedures similar to NRC's

IMC 2800. -States also

conduct inspections of

licensees working under

reciprocity in their

jurisdictions. Reciprocity

notifications are required.

Each state can establish

how long a licensee may

operate under reciprocal

recognition in their state.

The duration for reciprocity

ranges from 30 to 365 days

in a year.

NRC

NRC performs inspections of specific licensees as specified

in Inspection Manual Chapter (IMC) 2800. NRC also

performs inspections of exempt distribution licensees

located in both non-Agreement States and Agreement

States.

Reciprocity notifications are required. NRC conducts

reciprocity inspections of Agreement States licensees when

licensees are working in NRC jurisdictions. NRC may

choose to conduct inspections at Agreement States

licensee's home office to review activities conducted in

areas under NRC jurisdiction. Reciprocity is limited to 180

days in any calendar year.

In FY 2001, NRC implemented rules to register and track

certain general licensees using the General License

Tracking System.

Agreement States use

different mechanisms for

providing regulatory

oversight for general

licensees. The type and

frequency of inspection of

general licensees varies

among the existing

regulatory programs.
3.11

Current Program

C. Incidents/Allegations

States

Agreement State inspection

programs investigate

incidents and allegations.

As a matter of compatibility,

Agreement States are

required to report any

reportable events to the

NRC on a monthly basis.

Incidents involving NARM

and machine produced

radiation may also be

reported to NRC to be

included in NMED. Incidents

involving media attention are

also reported.

NRC

NRC's inspection programs investigate incidents and

allegations; NRC tracks allegations separately. The Nuclear

Materials Event Database (NMED) is used by the NRC to

trend and evaluate events involving equipment and

licensees. NRC and Agreement State events are tracked

and evaluated by the Generic Assessment Panel to identify

safety significant events and generic issues. NRC reports

annually to Congress on abnormal occurrences on behalf of

NRC and Agreement State licensees. NRC uses some

event data to demonstrate accomplishments under its

Strategic Plan.
3.12

Current Program

D. Materials Licensing Guidance, Inspection Guidance and Rulemaking

States

Agreement States develop and share

guidance with other states. CRCPD

coordinates with states through Working

Groups that develop some licensing

guidance. Some Agreement States

develop guidance for their programs

independently or by modifying guidance

in the NRC's IMC 2800 or NUREG 1556

series. Some states choose to use the

NRC's guidance without modification.

States also adopt or use guidance in a

manner similar to NRC.

Agreement States provide comments to

NRC on its rulemaking agenda and on

proposed rules. After NRC has

established the compatibility level for a

rule and adopted it, Agreement States

typically have three years from the

effective date of that rule in which to

adopt the rule or implement other legally

binding requirements.

NRC

NRC develops licensing and inspection

guidance for AEA material licenses and

requests input from Agreement States. Most

licensing guidance is found in the NUREG 1556

series. In developing its guidance, NRC must

consider use of existing guidance from

standards developing organizations. Guidance

from other entities, such as the International

Commission on Radiological Protection (ICRP),

National Council on Radiation Protection and

Measurements (NCRP), International Atomic

Energy Agency (IAEA) or International

Standards Organization (ISO), and other

professional organizations is also considered

when appropriate. NRC responds to

documented trends, incidents, inspection

findings, petitions, technological advancements

and research. NRC establishes the rulemaking

agenda, drafts the rule (with Agreement State

participation and input for some rules),

establishes the compatibility categories for or

within each rule, and monitors implementation in

keeping with its oversight function.

E. Training, Qualifications and Experience Standards for Regulatory Personnel

States

Agreement States develop and train staff

to meet their program requirements.

Many states use training programs

developed by NRC. When needed

training programs are unavailable,

states either contract with groups within

their state or join with other states to

provide specific training for their staffs.

The adequacy of each Agreement

State's training program is evaluated

during IMPEP reviews.

NRC

NRC staff are trained and qualified as specified

in IMC 1246. The adequacy of training for

regional staff is evaluated during IMPEP

reviews.
3.13

Current Program

2. What are the Roles/Responsibilities of NRC and States in the Current FederallStates

Relationships?

NRC communicates with others by working with organizations and groups and by distributing

information. NRC works with OAS and CRCPD. NRC distributes documents such as All

Agreement States Letters, enforcement notices, the Regulatory Agenda, and bulletins to convey

information.

Agreement State representation in NRC working groups is often solicited through OAS. NRC

and OAS Executive Board review the status and progress of joint Working Groups, receiving

information monthly from Working Group chairs. NRC provides no direct funding to the OAS, but

funds the transcription services provided for the OAS annual meeting.

NRC has worked with CRCPD for many years. NRC provides funding directly to CRCPD

thorough a federal umbrella grant administered by the Food and Drug Administration (FDA).

NRC provides a liaison to the CRCPD's Board of Directors. The liaison participates in all

meetings of the Board and serves as a conduit for the flow of information between NRC and

CRCPD. CRCPD's working groups modify NRC rules to adapt for state use. CRCPD Working

Groups draft rulemaking, guidance and other documents for non-AEA materials which are usually

adopted by the states. The CRCPD's SSRCRs are available for use by states.

Individual Agreement State programs coordinate with NRC on routine regulatory issues. States

respond to NRC requests for comment on activities such as rulemaking plans, proposed rules,

and guidance documents. Agreement States provide personnel to serve on various NRC

working groups. Agreement States provide information on incidents, misadministrations, and

other activities that assist NRC in evaluating current trends and in fulfilling its responsibility in

reporting to Congress. Agreement States must conduct activities such that NRC finds them

adequate to protect public health and safety and compatible with the NRC. States, either

independently or in groups, may also draft rules as necessary.

3. Are Statutory Changes Required for this Option?

No statutory changes are needed to maintain the current program.

4. What Coordination is Required?

No additional coordination efforts were identified to maintain the current program.
3.14

Current Program

5. Resources Needed and Who Pays?

NRC resources support materials licensing, inspection, guidance development,

incident/allegations investigations, research, legal advice, adjudication, enforcement, and IMPEP

(travel and per diem for state members). Agreement State resources support materials licensing,

inspection, guidance development, incident/allegations investigations, legal advice, adjudication,

enforcement, and IMPEP (salary for state members). NRC pays travel and per diem for state

members on working groups, advisory committee members, and steering committees. States

pay the salary for their staff who serve and allow them the time to perform the duties.

NRC resources are also used to support the NMED and SS&D Registry databases with the

information being provided by NRC and the Agreement States. NRC and Agreement State

resources also support their respective rulemaking processes, including public meetings and the

cost of publishing and distributing rules.

CRCPD uses funds provided by NRC to CRCPD through the FDA umbrella grant to develop SSRCRs and technical support documents. NRC resources for various program functions are

shown in Figure 3.1. These numbers will be used to compare relative changes to resources for

various options described.

Figure 3.1 - NRC Resources for Current Program

Activity Costs*

$ in FTE

millions

NMSS**, Regions $ 26.6 197

Direct Support*** $ 10.0 63

Agency Overhead**** $ 18.4 76

Total $ 55.0 336

* These resource estimates are based on NRC's FY 2001 budget, and used as the base case for comparison of the various options throughout this section. Costs are the sum of contract support, travel costs and staff

salaries and benefits.

** NMSS means NRC's Office of Nuclear Materials Safety and Safeguards. These resources include State and Tribal Programs, Materials Research, Incident Response, Enforcement,

Investigations, Legal Advice, and Adjudication. **** These include indirect resources providing policy, financial, administrative, information technology infrastructure, personnel support, and physical plant support (rent, utilities, building maintenance, etc.).
3.15

Current Program

6. Accountability

NRC is accountable to Congress for all activities under the AEA. States are accountable to their

respective legislative and executive branches of government. State accountability involves

activities within state jurisdictions regarding state radiation control statutes and rules. All

regulatory agencies are accountable to their licensees and members of the public. Agreement

States are required to report certain information to NRC as a matter of compatibility.

7. Program Assessment

NRC is responsible for evaluating Agreement State radiation control programs and NRC

Regional materials programs. NRC uses an integrated method using common and non-common

performance indicators as specified in Management Directive 5.6, Integrated Materials

Performance Evaluation Program (IMPEP). NRC's Office of State and Tribal Programs has the

leadership responsibility for coordinating Agreement State IMPEP reviews; NRC's Office of

Nuclear Materials Safety and Safeguards coordinates NRC regional materials program IMPEP

reviews. NRC and Agreement State members are trained to conduct IMPEP reviews. NRC

schedules the reviews, assigns the review team members and manages the entire process.

Review teams are comprised of three or more members, one of whom is from an Agreement

State. A team, comprised of three Agreement State staff and one NRC staff member, was used

for the review of Headquarter's SS&D program. The IMPEP review of states evaluates the

adequacy and compatibility of the state's programs. NRC uses its IMPEP process to review

regional materials programs for adequacy.

8. Program Gaps

The AEA does not address NARM. NARM licensees of the NRC located in non-Agreement

States and federal facilities are subjected to widely varying regulatory practices. Some nonAgreement States have aggressive licensing or registration programs for these non-AEA

materials, while other states have no programs. Federal facilities and Indian tribes located in

either Agreement or non-Agreement States can use non-AEA materials without regulatory

oversight. For example, an employee of a federal agency (in the performance of official duties)

can use a portable device containing NARM without regulatory oversight in any state.
3.16

Independent States

____ M_

Independent States assume responsibility for AEA materials in their jurisdictions.

Section 274 of the AEA, which includes the Agreement State program, is abolished. No

NRC oversight of state programs exists. NRC relinquishes control of AEA materials to

the states and maintains authority over federal facilities and certain quantities of special

nuclear material. The resulting national program could be either separate independent

groups of states that function as one unit but separate from NRC, or fully autonomous

states operating independently from one another.

This option does not include a mechanism that ensures uniform protection of public

health and safety on a national level, but it is included as an extreme to help bound the

remaining options.

What are the roles/responsibilities of NRC is responsible for regulation of AEA materials, licensing, inspection,

NRC for each program element? rule promulgation, guidance development, and incident/allegation

investigation only at federal facilities and in areas of exclusive federal

jurisdiction. NRC continues to have authority over materials subject to

international safeguards. NRC is not responsible for state oversight.

What are the roles/responsibilities of States have authority for regulation of all radioactive material, including

an Agreement State for each program licensing, inspection, rule promulgation, guidance development, and

element? incident/allegation investigation functions.

Are statutory changes required? Changes to the AEA are needed to disassociate NRC from some AEA

materials responsibilities. The Agreement State program ceases and states

may need to obtain statutory authority to regulate AEA materials.

What coordination is required? In its purest form, this option would involve no coordination. In practice, 1

states may decide to coordinate through an entity such as OAS or CRCPD.

What resources are needed (federal Each entity would fund its own program as necessary to meet its own

and state)? needs.

Who would pay?

Accountability NRC and states are accountable to the same entities described in the]

Current Program. I

Program assessment Federal and state regulatory programs would be self-assessing. No federal

oversight exists and therefore no assessment of the national program

occurs.

Program Gaps Possible gaps when interstate issues are involved for NARM and AEA

materials.
3.17

Independent States

Advantages

Independent States option saves

some NRC resources because NRC

would be relieved of its

responsibilities for regulating AEA

materials in the states.

States gain complete control over all

uses of radioactive materials within

their borders, allowing them to

develop a homogenous program.

States develop regulatory products

and tailor their programs to fit their

own needs and have ultimate

flexibility.

Regulatory requirements for all

radioactive materials are consistent

within each state if coordination

occurs.

Disadvantages

NRC retains all of the elements of a materials

program because it continues to regulate federal

facilities and certain quantities of special nuclear

material. However, the scope of NRC's

materials program changes because of the

different mix of types of licenses and the smaller

licensee base. There may be an erosion of

expertise within NRC.

Not all states would be willing or able to accept

responsibility for regulating AEA materials.

Statutory or financial barriers could prevent

establishing a more comprehensive program. In

addition, a small number of AEA materials

licensees in a particular state would also make it

impractical to implement a program. As a result,

AEA materials may go unregulated in some

states.

Lack of compatibility or consistency between

state programs could adversely affect licensees

who operate in several states to an even greater

extent than it currently does. Licensees would be

faced with an even greater degree of

inconsistency than at present, resulting in higher

costs as they deal with these different and

possibly divergent programs. Their ability to

maintain a compliant operation would be

hampered.

Without interstate coordination between

individual state regulatory programs, duplication

of effort would be unavoidable as each entity

took it upon itself to "reinvent the wheel" to

respond to radiation safety challenges of

changing and new technologies.
3.18

Independent States

1. Roles and Responsibilities of NRC and States for Each Program Element

Under this Option, states have the responsibility for addressing radiation protection program elements. NRC has the responsibility for addressing radiation protection program elements only at

federal facilities and in areas of exclusive federal jurisdiction. NRC continues to have authority over

materials subject to international safeguards.

2. What are the Roles/Responsibilities of NRC and States in the Current Federal/States

Relationships?

NRC discontinues its regulatory authority over AEA material in all states, as it does now in

Agreement States. In addition, NRC relinquishes its oversight role for adequacy and compatibility of

state regulatory programs. However, in several areas NRC may need to retain control:

a. radioactive material at federal entities, such as VA hospitals and government departments b. radioactive material in areas of exclusive federal jurisdiction, such as tribal lands

c. radioactive material subject to international safeguards such as special nuclear materials in

quantities sufficient to form a critical mass and certain other materials, which are the subject of

nuclear non-proliferation treaties. Note that the federal government has international treaty obligations related to safeguards of these materials and it is unlikely that these obligations can be

transferred to a state.

NRC is responsible for licensing including SS&D evaluations, compliance inspections, investigations, enforcement and development of rulemaking and guidance only to the extent necessary for

regulation of materials specified in (a), (b) and (c).

To the extent that each state is willing or able to accept the responsibility, NRC transfers control to

each state for all AEA material not covered in (a), (b) and (c) above. Each participating state would

be responsible for licensing, compliance inspections, investigations, enforcement, and developing rules and guides. States would also continue to be responsible for low-level waste facilities within

their borders.

3. Are Statutory Changes Required for this Option?

Changes to the AEA would be required. Revision to relieve NRC of the responsibility for regulating AEA material in all states, and for the oversight of state programs, currently required by Section 274,

would be necessary.

For each state to accept this responsibility, state legislation may be needed in order to incorporate AEA materials into their program. Programs may also need to be restructured to accommodate the

change.
3.19

Independent States

4. What Coordination is Required?

With one or more independent groups of states operating autonomously, a coordinated national

effort to harmonize programs would be needed. However, unless all states participated in this

coordinated effort, problems of inconsistency and duplication would exist. A redesigned CRCPD

could provide the basis for nationwide coordinated effort. On the other hand, if 50 separate states

operated their programs autonomously, no coordination would be required.

5. Resources Needed and Who Pays?

Each entity would fully fund its own program as necessary, either from license fees, general revenue

funds, or combinations of sources. Figure 3.2 compares NRC resources currently expended on

various program elements and the resulting change to program costs under this Independent States

option.

Figure 3. 2 NRC Resources for Current Program and Independent States Option

Activity Current Current Independent Independent

Costs* FTE States Costs States

($ in ($ in FTE

millions) millions)

NIVMSS, Regions $ 26.6 197 $ 2.0 14

Direct Support** $ 10.0 63 $ 0.4 4

Overhead*** $ 18.4 76 $ 1.3 5

Total $ 55.0 336 $ 3.7 23

Source: NRC's FY 2001 budget

* Costs are the sum of contract support, travel costs and staff salaries and benefits .

** Resources include State and Tribal Programs, Materials Research, Incident Response,

Enforcement, Investigations, Legal Advice, and Adjudication.

Resources include indirect resources providing policy, financial, administrative, information

technology infrastructure, personnel support, and physical plant support (rent, utilities, building

maintenance, etc.).
.3.20

Independent States

NRC continues to be responsible for approximately 500 materials licenses held by federal government departments and in the areas of exclusive federal jurisdiction. This represents approximately 10% of the number of licenses currently under the NRC's control, and because of this, the number of NRC FTE required would decrease. When the reduction would result in less than one FTE, the working group assigned one FTE so that a presence would be maintained. Because NRC's oversight of state programs would no longer be required, and virtually all AEA materials licenses would be turned over to the states, many program elements currently residing at NRC, such as the Office of State and Tribal Programs and NMSS support of state activities would disappear completely. Additional resource decreases are found in the areas of research, licensing, inspection, and writing guidance.

6. Accountability

NRC and states are accountable to the same entities described in the Current Program.

7. Program Assessment

Section 274 of the AEA would be abolished, along with NRC's oversight authority. NRC would not have oversight responsibility and without a lead federal entity, there would be no formal regulatory program review. However, states might find it beneficial to know the abilities and scope of other state programs. For instance, how out-of-state licenses or SS&D evaluations are accepted from other states would be of interest. In such cases, CRCPD might implement some form of voluntary program review. CRCPD has such a role in Licensing State designations.

8. Program Gaps

Significant gaps in radiation protection programs could occur. Seriousness would depend on the degree to which states choose to undertake responsibility for regulating either NARM, AEA material, or both. States may choose to:

* regulate neither AEA material nor NARM

* register NARM

* license NARM

* register (former) AEA material

* license (former) AEA material

* use any combination of the above to regulate the use of radioactive material

In addition to gaps in individual programs, additional gaps due to the lack of formal coordination between state programs could occur. For example, gaps could develop when interstate issues such as reciprocity are involved.
3.21

Minimum NRC Involvement

Minimum NRC Involvement requires NRC to maintain authority over AEA materials. NRC maintains a

voluntary Agreement State program. NRC streamlines its operations to continue to meet the minimum

requirements of the AEA. NRC can determine the intensity and level of its activity. Depending on how NRC

modifies its policies to meet the minimum requirements of an adequate program, cost savings may occur.

NRC maintains authority at federal facilities, in non-Agreement States, and over AEA material in Guam,

Puerto Rico, U.S. Virgin Islands, and the District of Columbia (unless those entities desired to become an

Agreement "State" as provided by Section 274(n)).

Uniform core regulatory requirements would exist in the United States to ensure a consistent approach to

regulating the use of AEA material, especially in "basic radiation protection standards and definitions."

Promulgation of new rules or modification of existing rules in 10 CFR Parts 19, 30-40, 61, 71, and 150 would

either not occur, or occur only when there is a significant need for modification.

Other regulatory activities such as guidance development and research can be modified to allow NRC to

meet its minimum legislative requirements. These other activities were not evaluated by the Working

Group for their health and safety significance, but could serve as examples for later consideration.

What are the roles/responsibilities of Most program elements common to NRC and states are not specified in the AEA, but exist as

NRC for each program element? policy decisions to execute NRC's charge for maintaining health and safety. NRC modifies its

current policies and requires less resources to implement the AEA. The role of NRC in each

program element changes due to policy changes. The number of NRC licensees and the

number of Agreement States continues to change.

What are the roles/responsibilities of Agree ment States have responsibility for all elements within their jurisdiction.

Agreement States for each program

element?

Are statutory changes required? No. This Option assumes the current AEA status, with some NRC policy changes.

What coordination is required? NRC's OSTP eventually has a larger number of Agreement States to work with, but the basic

program structure already exists. Better coordination among Agreement States and with NRC

results in better use of resources.

What resources are needed (federal Federal resource requirements decrease, but resources continue to be necessary to carry out

and state)? activities specified in the AEA. NRC needs appropriated funding because of smaller licensee

Who would pay? fee base. States continue to fund their own programs.

Accountability Accountability does not change from the Current Program.

Program assessment Program assessments can be significantly reduced to match NRC's reduction in resources.

IMPEP may be reduced to a telephone call or self-evaluation.

Program Gaps Program gaps are the same as those identified in the Current Program. Experience and

expertise may continue to shift away from NRC with the declining licensee base.
3.22

Minimum NRC Involvement

Advantages Disadvantages

NRC and Agreement States would

save resources. NRC probably would

decrease rulemaking which decreases

corresponding state efforts.

NRC must develop less resource-intensive

methods to assure that public health and safety is

maintained.

If NRC reduced or eliminated IMPEP and NMED,

there might not be a centralized source of

information for NRC to assess the efficacy of the

national program.

Some licensees will continue to be subject to more

than one regulatory agency, and licensees with

interstate activities will continue to deal with

multiple jurisdictions and rules.

Minimum NRC involvement reduces coordination

between NRC and States.
3.23

Minimum NRC Involvement

1. Roles and Responsibilities of NRC and States for Each Program Element

A. Performing Materials I

Radioactive Waste, Urain

States

Minimal changes would be

required in Agreement State

programs. If NRC issues more

types of general licenses, states

would be requested by industry

to do the same. If exempt

distribution could be authorized

by Agreement States, minimal

effects to Agreement States and

savings for licensees could

result.

Agreement States that perform

safety evaluations would

continue to do so. States that

have agreed to let NRC do such

evaluations may need to develop

an evaluation program.

States would be responsible for

addressing all new issues

developing in the waste arena.

There would be no change to

uranium recovery or

decommissioning programs.

Licensing (including Sealed Source and Device Reviews, Low-level

dium Recovery, and Decommissioning)

NRC

NRC could modify how it licenses AEA material. For

example, the number and frequency of licenses

reviewed and issued could be decreased by

expanding general licensing and/or establishing a

registration program.

The a priori safety evaluation of SS&Ds containing

AEA material is not specified in the AEA, therefore,

NRC could evaluate each device every time a

licensee wishes authorization to use such a device.

However, this is not an efficient mechanism for

licensing. NRC continuing to issue SS&D evaluations

would be the best alternative. On the other hand, the

requirement for NRC to maintain a SS&D registry is

not specified in the AEA. This task could be

eliminated, contracted, or published on a website,

with each regulatory agency voluntarily posting

information.

The Low-Level Radioactive Waste Policy Amendments

Act of 1985 gave states responsibility to dispose of lowlevel waste generated within their borders. It allows

states to form Compacts to locate facilities to serve a

group of States. Staff in the reactor arena could assist

with some low-level waste issues.

There would be no change to the current uranium

recovery and decommissioning programs.
3.24

Minimum NRC Involvement

B. Performing Materials Inspections

States

There would be no change required

in the Agreement State programs.

NRC

Inspection of licensees is not specified in the AEA; however,

the Working Group has identified an inspection program to be

a necessary component of an adequate program. The scope

of NRC's inspection program is policy driven; therefore, NRC

could modify its method of performing inspections by

contracting inspections, or by allowing self-inspections by

licensees, with NRC retaining the final determination of public

health and safety. In addition, NRC could modify the scope

and frequency of inspection of licensees, including reciprocity

inspections in the non-Agreement States, territories, and the

District of Columbia.

C. Incidents/Allegations

States

No change would be required in the

Agreement State incident response

programs. Agreement States would

no longer be required to report to

NRC if NMED is eliminated, or would

be required to report only the most

egregious incidents to a scaled-back

NMED.

NRC

NRC response would be limited to licensees under NRC

jurisdiction. The NMED system, used for generic assessment

and event tracking, is not required under the AEA, and could

be limited to NRC-licensee events. Under the most far

reaching changes to NRC's program, NMED could be deleted.
3.25

Minimum NRC Involvement

D. Materials Licensing Guidance, Inspection Guidance and Rulemaking

States

As NRC generates fewer changes to

rules, state rulemaking will decrease

and fewer compatibility issues will

result. Agreement States would

continue to develop individualized

rules, but would continue to be

required to be compatible with NRC's

basic radiation protection standards.

Agreement States would use sources

of information from CRCPD's

SSRCRs, standard developing

organizations, and other federal and

state agencies.

NRC

NRC would need rulemaking resources for basic radiation

protection standards and amending 10 CFR Parts 19, 30

through 40, 61,71 and 150. NRC would rely heavily on other

entities for developing standards and rules; NRC would follow

the Administrative Procedures Act for final adoption of rules.

NRC's activity in developing or maintaining guidance

documents could range from non-existent to limited, for

instance, to developing some basic documents related to

radiation safety.

E. Training, Qualifications and Experience Standards for Regulatory Personnel

States

Each state is responsible for

maintaining a level of staffing that is

adequate to provide public health and

safety. Therefore, each state must

make sure that staff have adequate

training. This option would affect

those states that use NRC's current

training program because NRC would

reduce training opportunities.

NRC

Depending on the assumptions made, NRC's staffing could

change dramatically. Increasing the use of general licensing

and performing fewer inspections would decrease the number

of staff requiring training and qualifying in accordance with

NRC's IMC 1246. NRC's Technical Training program would be

significantly decreased for the materials arena.
3.26

Minimum NRC Involvement

2. What are the Roles/Responsibilities of NRC and States in the Current Federal/States Relationships?

NRC responsibilities continue under the current AEA in:

* standard setting

* oversight of Agreement State programs for adequacy and compatibility

* regulation of licensees in non-Agreement States

* regulation of Federal agencies, areas of exclusive federal jurisdiction, tribal lands

* production and utilization facilities, special nuclear materials (above certain amount)

* disposal in the ocean

* high level waste disposal

* off-shore waters

* certain aspects of mill tailings

This option would require NRC to make dramatic policy changes for executing its obligations. For instance,

the AEA requires that NRC take the leadership role in regulation of AEA material throughout the U.S., but

it does not define the level of effort required of NRC to meet that statutory obligation. NRC's focus on

regulatory research would be in support of the basic radiation safety standards contained in 10 CFR Part

20. Therefore, NRC resource requirements for materials programs would decrease significantly because

basic radiation safety would be addressed in the reactor safety arena, with assistance from the materials

arena when needed.

This Option requires the NRC to fulfill its obligations under the AEA, but would also include program elements identified by the Working Group as being necessary for an adequate radiation protection program. The Working Group considered more radical changes that were determined not to be protective of public health and safety. For this reason, these were not pursued further.

3. Are Statutory Changes Required for this Option?

This Option assumes no changes to statutory requirements are necessary for NRC, or for the states.

Without change to the AEA, NRC would establish a minimum level of resources necessary to perform its

duties, regardless of the number of licensees or the number of Agreement States. With changes in certain

policy decisions, NRC could minimize its current level of effort. This could include elimination of NMED and

IMPEP.
3.27

Minimum NRC Involvement

4. What Coordination is Required?

With the potential minimization of the NRC's program, more collaborative interactions among the states

would be required. NRC may continue to need to gather information from all states for unusual events

and abnormal occurrences, depending upon policy changes made. Coordinated training would be

necessary because the expertise will be shifting from NRC to the states for many categories of

licensees.

5. Resources Needed and Who Pays?

The overall effect is minimal for states, but could result in savings for the NRC because fewer NRC

resources would be required to support this program. As indicated earlier in this document, the Working Group used the current program as the base case. Compared to the current program, NRC could

reduce its resource needs by changing regulatory policy, thus varying the scope of activities, ratherthan

changing statutes. A "minimum" NRC presence could include a wide range of options, depending on

the degree to which NRC policy might change.

Because it is impossible to predict what level of regulatory oversight NRC would adopt by policy under

a given minimum program, the Working Group evaluated a range of options. Two variations are

presented in Figure 3.3 below.
3.28

Minimum NRC Involvement

Figure 3.3 - NRC Resources for Current Program and Minimum NRC Involvement

Activity Current Program Minimum Support Minimum NRC

Costs* Option+ Program Option++

($ in millions) (FTE) ($ in millions) (FTE) ($ in millions) (FTE)

NMSS, Regions $ 26.6 (197) $ 16.7 (158) $ 15.0 (105)

Direct Support** $ 10.0 (63) $ 5.3 (50) $ 6.0 (50)

Agency Overhead*** $18.4 (76) $ 14.7 (61) $ 11.0 (45)

Total $ 55.0 (336) $ 36.7 (269) $ 32.0 (200)

* These resource estimates are based upon NRC's FY 2001 budget, and are used as the base case for comparison

of the various options throughout this section. Costs are the sum of contract support, travel costs and staff salaries

and benefits.

These resources include State and Tribal Programs, Materials Research, Incident Response, Enforcement,

Investigations, Legal Advice, and Adjudication.

These include indirect resources providing policy, financial, administrative, information technology infrastructure,

personnel support, and physical plant support (rent, utilities, building maintenance, etc.).

+ This option assumes the NRC licensing and inspection programs do notchange, but rule and guidance development

are reduced substantially, the general license program is assumed to support follow up for a second round of

registrations, NMED and event evaluation support only NRC's licensees, the orphan source and low level

radioactive waste programs are eliminated and state program activities are limited to interactions with perspective

Agreement States, review of Agreement States and reduced interactions with OAS and CRCPD.

++ This option assumes no materials research, guidance development, IMPEP, orphan source program, or grants for

terminated sites in Agreement States; no NMED and no onsite inspections other than in response to incidents. In

addition, rulemaking and support to Agreement States are reduced.

6. Accountability

NRC and states are accountable to the same entities described in the Current Program.
3.29

Minimum NRC Involvement

7. Program Assessment

The AEA requires NRC to evaluate the adequacy and compatibility of Agreement State programs but

the AEA does not specify the depth or scope of reviews. This program effort could be minimized through the modification or elimination ofthe currentAgreement State oversight program, including IMPEP. For

example, during the initial years of the Agreement State program, evaluations consisted of only a short

visit from a regional NRC representative. Agreement State reviews could be reduced to a visit from an

NRC representative, a telephone call update, or the state could be requested to complete a

questionnaire for NRC to review and maintain on file.

This Option would require no change to existing agreements between NRC and the States.

8. Program Gaps

Similar to the current structure, non-AEA material at facilities, territories, and states not entering into

Agreements is not addressed by this option.
3.30

Alliance

An Alliance is a cooperative process between the States and NRC that identifies radiation safety

regulatory priorities and the means to address those priorities. The process may operate

between the States and NRC or it may involve other federal and state regulatory agencies on

radiation issues.

The Alliance Option is the structure that most completely encompasses the common attributes

of shared goals and decision-making, shared resources, and shared responsibility.

The Alliance requires a consensus structure, one based on general agreement and consists of

decisionsljudgements arrived at by most of those concerned. Consensus does not indicate

unanimity of a group, but is a process that provides an opportunity for all parties in the group to

bring their individual ideas, opinions, and input to the table so that participants are empowered

and can agree to accept decisions made by the group.

What are the NRC and states share responsibility for

roles/responsibilities of the - identification of regulatory products

NRC for each program - prioritization of product development

element? - development of corresponding rules and guidance.

NRC would obtain authority for discrete NARM.

What are the NRC and states share responsibility for

roles/responsibilities of - identification of regulatory products

Agreement States for each - prioritization of product development

program element? - development of corresponding rules and guidance.

Are statutory changes Yes, to eliminate the regulatory gap for NARM.

required?

What coordination is More efficient coordination between the NRC, states, OAS and CRCPD is required.

required?

What resources are needed Each regulator provides the workforce and financial resources to carry out their respective

(federal and state)? legislative mandates.

Who would pay? On joint projects, NRC pays for per diem and travel and states pay salaries and provide

time to work on Alliance activities.

NRC also covers most of infrastructure, e.g., publications, national databases, etc.

Accountability No change from the Current Program.

Program assessment Program assessment through IMPEP, including review of states, Regions and NRC

Headquarters for SS&D review.

Program Gaps AEA would need to be amended to include NARM. The only gap regarding radioactive

materials would be diffuse NORM.

NOTE CONCERNING RESOURCES: For states, out-of-state travel is more than just a budgetary issue. Often

because of policy/political issues, unless funded by someone other than the state, state employees are not allowed to

travel out-of-state.
3.31

Alliance

Advantages

The Alliance option most

completely encompasses the

common attributes desired in a

National Materials Program.

Attributes consist of shared

goals and decision-making,

shared resources, and shared

responsibility.

Advantages to a consensus

structure are that all parties have

an opportunity, if not an

obligation, to participate

meaningfully in a spirit of true

partnership.

Disadvantages

Negotiations to achieve consensus require time and

resources. Sometimes these costs could be significant. Individuals who participate would need the authority to

make the decisions necessary to reach consensus.

This may not always be the case.

This option assumes NRC would obtain authority to

regulate discrete NARM. This could result in some

non-Agreement State radioactive materials programs being dissolved, unless the option encouraged or

forced non-Agreement States to seek Agreement State

status.

Benefits of consistency in the

program result, demands on

resources are spread among the

participants, and sharing of

responsibility occurs. These

accomplishments inspire public

confidence.

Obvious resource savings

accrue when resources are

shared.
3.32

Alliance

1. Roles and Responsibilities of NRC and States for Each Program Element

A. Performing Materials Licensing (including Sealed Source and Device Reviews, Lowlevel Radioactive Waste, Uranium Recovery, and Decommissioning)

These activities would be performed as they are in the Current Program. Contracted entities or

Centers of Expertise could be used to perform some license reviews or portions of reviews for

specific technical areas.

B. Performing Materials Inspections

The current inspection program would be maintained, but would be supplemented with other

options. NRC would perform inspections for all facilities authorized to possess and use

radioactive materials (now including NARM) in non-Agreement States and at federal facilities in

Agreement States. NRC would also perform inspections of general licensees and exempt distribution licensees located in non-Agreement States and Agreement States.

Other options include:

1. allowing other entities to contract with NRC and Agreement States to perform inspections and report results to the appropriate regulatory agency;

2. allowing licensees to perform self-audits which may be accepted in lieu of inspection by NRC

and Agreement States or reduce inspection effort by NRC and Agreement States*;

3. accept audits performed by other organizations and use these as a supplement to NRC and

Agreement State inspections to reduce inspection effort by NRC and Agreement States*; or

4. use Centers of Excellence to perform inspections of specific technical areas.

*Acceptance of licensee audits or audits performed by independent organizations to modify NRC

and Agreement State inspection effort would be determined by the appropriate regulatory

agency in a selective manner. Centers of Expertise could be either Agreement State or NRC

organizations and would be jointly recognized by NRC and Agreement States.

C. Incidents/Allegations

A national Information Infrastructure regarding incidents will need to be maintained.
3.33

Alliance

D. Materials Licensing Guidance, Inspection Guidance and Rulemaking

Development of rules and guidance is discussed in detail in "Regulatory Process Under the

Alliance" later in this section.

E. Training, Qualifications and Experience Standards for Regulatory Personnel

The current training, qualifications, and experience standards would be maintained and be

enhanced with:

1. use of an Information Infrastructure for training ideas, resources, and opportunities designed

for or employed by NRC and Agreement States

2. allowing licensees to provide training, on a voluntary basis, for specific technical issues or

consider contracting with licensees to train staff in specific technical areas

3. encouraging a regulatory agency exchange program to develop staff in specific technical

areas

2. What are the Roles/Responsibilities of NRC and States in the Current Federal/States

Relationships?

NRC and States share responsibilities except where noted. NRC maintains oversight for

adequacy. NRC funds and continues to coordinate and participate in the IMPEP process. Equal

participation under the IMPEP process, with voting status on the management review board for

States, should be considered.

The roles and responsibilities of the CRCPD and OAS can vary under the Alliance, depending

upon decisions made by the Commission regarding a National Materials Program.

3. Are Statutory Changes Required for this Option?

Congress would need to make statutory changes to authorize NRC authority for NARM. A few

Agreement States may have to amend laws so that they may adopt Alliance products. Some

laws currently require states to adopt SSRCRs developed by CRCPD.
3.34

Alliance

4. What Coordination is Required?

Activities of CRCPD that could be impacted by the Alliance are development of the SSRCRs and the products developed by many of the Environmental Council Committees. In anticipation of potential changes, the CRCPD Board created a committee to evaluate the CRCPD's role in radioactive materials rulemaking and make recommendations to the Board concerning changes in that role. This committee is coordinating its efforts with the National Materials Program Working Group.

OAS activities involving assignment of persons to NRC working groups could be similarly impacted. OAS issues could potentially be addressed through the Alliance process.

Both organizations are involved with the Working Group and are aware of the potential need to evaluate and change the functions of the organizations. Any changes made will be dependent upon the Commission's decision regarding a National Materials Program. If that decision incorporates the Alliance, changes in the organizations will be geared toward reducing duplicate efforts and increasing efficient use of resources.

5. Resources Needed and Who Pays?

Sharing responsibilities with the states would reduce costs to the NRC. While NRC would be required to issue rules, developing them in collaboration with the states will reduce NRC costs. For areas not involving the "core" concerns of the NRC, NRC may not need to be involved in a rulemaking at all, or be involved at a minimum level of effort. The NRC could then choose to adopt the rule through its normal rulemaking process.

Priorities set by decision-makers for the NRC and states are set by those who can commit

resources. Resources committed by the states are expected to be the same type of resources currently committed. For example, when a state representative participates on a working group or an IMPEP team, the state pays the position costs and NRC pays the travel and per diem. Because many states have difficulty is funding out-or-state travel, it is preferable that NRC continue to cover travel and per diem. With proper planning and use of conference calls, the majority of the expense for developing a regulation or guidance document would fall to the states that had the leadership role.

Both licensees and taxpayers would pay for the cost of a National Materials Program. The mix between the two will depend on the legislature controlling each agency's budget. It is not expected that all agencies will be equally involved in all areas. On priorities that are high, several agencies will participate, thus spreading the cost. An agency may work on a product independently, either because it chooses to, it is required to by legislation, or as a result of a petition that is not related to a national priority. In that case, the agency, and its licensees and its taxpayers, will cover the entire cost of the work.
3.35

Alliance

NRC will regulate NARM. This should not result in a significant increase in resources for the

NRC in most categories of licenses. The vast majority of non-Agreement State NORM licensees

are already licensed by the. NRC because of the AEA materials they use. Regulatory burden for

those licensees that are now licensed by both NRC and the non-Agreement States would be

reduced. NRC currently devotes resources to NARM. For instance, NRC investigated

Mallinckrodt overexposures from NARM. NRC has been involved in issues concerning pre-1978

mill tailings.

Budgeting would be similar to the Current Program. Each regulatory agency would continue to

be responsible for the budget necessary to carry out its licensing and inspection activities.

Likewise, each agency would be responsible for directions imposed on it by its legislature and

for responding to petitions for rulemaking. Activities conducted jointly among agencies through

the Alliance as national priorities are those that the other agencies would have supported

independently.

Funding for the Alliance Administrative Core should be evaluated by an implementation

committee after CRCPD, NRC, and OAS agree to a formal working relationship with formal

communication channels. The functions of the Administrative Core (discussed in detail later in

this section) are currently being performed and funded, sometimes in duplication, among states,

NRC, CRCPD, and OAS. Some roles will be increased and some will decrease. Efficiencies

should reduce overall costs.

The following chart shows current costs and the cost of an Alliance option depending upon the

number of Agreement States.

Figure 3.4 - NRC Resources for Current Program and Alliance Option

Activity Current Program Alliance (32 States)* Alliance (50 States)**

Costs* ($ in millions) (FTE) ($ in millions) (FTE)

($ in millions) (FTE)

NMSS, Regions $ 26.6 (197) $ 24.3 (181) $ 9.4 (58)

Direct Support $ 10.0 (63) $ 10.0 (63) $ 7.9 (46)

Agency Overhead $ 18.4 (76) $ 17.3 (71) $ 7.4 (31)

Total $ 55.0 (336) $ 51.6 (315) $ 24.7 (135)

* These resource estimates are based upon NRC's FY 2001 budget, and are used as the base case for comparison of

the various options throughout this section. Costs are the sum of contract support, travel costs and staff salaries and

benefits.

** These resources include State and Tribal Programs, Materials Research, Incident Response, Enforcement,

Investigations, Legal Advice, and Adjudication.

*** These include indirect resources providing policy, financial, administrative, information technology infrastructure,

personnel support, and physical plant support (rent, utilities, building maintenance, etc.).
3.36

Alliance

The Alliance requires a greater commitment of resources compared to other options, but the benefits are significant. Measurement of public confidence is difficult, but the Working Group believes this Option promotes harmony among regulators, encourages public participation, utilizes Centers of Expertise, and makes setting national priorities a very open and participatory process. These things build a stronger national program, which can then enhance public perception of efforts to protect workers and public health and safety.

6. Accountability

NRC and states are accountable to the same entities described in the Current Program.

7. Program Assessment

NRC would retain its responsibility to evaluate Agreement State radiation control programs and NRC regional materials programs using IMPEP. Under an Alliance, NRC may consider allowing an Agreement State representative to be a voting member of the Management Review Board.

8. Program Gaps

If the AEA is amended to incorporate discrete NARM, as recommended by the Working Group and stakeholders, the Working Group does not envision any program gaps other than the regulation of diffuse NORM.
3.37

Alliance Makeup and Structure

The Alliance consists of three groups: regulatory decision-makers, other stakeholders, and an

administrative core.

Regulatory decision-makers are state radiation regulatory program managers and NRC materials

program managers. Regulation of sources of radiation is a regulatory function. By statute, federal

and state agencies are charged with this regulatory responsibility. Therefore, these agencies are

the ultimate decision-makers regarding radiation regulation, are essential to the regulatory process,

and are the central component of the Alliance.

It is also hoped that under the Alliance, regulatory decision-makers would include, or seek the input

of other federal and state agencies charged with regulating radiation issues. Other agencies could

include EPA, DOE, and equivalent state environmental or health agencies depending on where the

state radiation control program is organizationally located.

Other stakeholders include licensees, the public, professional organizations, industry organizations,

and other federal and state agencies with an interest in radiation issues. The other federal and

state agencies are considered stakeholders because at this time, the effort towards establishing a

National Materials Program is being driven by NRC and representatives from the state radiation

regulatory agencies. Regulatory decisions by federal and state agencies must be informed

decisions. To make such decisions, it is necessary to actively seek and consider input from those

persons who would be effected. Stakeholders are also essential to the regulatory process and

should be considered as such by the Alliance, as they currently are by individual federal and state

agencies.

The administrative core can be considered the support staff for the Alliance membership and is

essential to the logistical process of the Alliance.

The Role of the Regulatory Decision-Makers

The responsibilities of the regulatory decision-makers within the Alliance include:

1. jointly establishing regulatory priorities and agenda

2. identifying Centers of Expertise

3. recognizing current regulatory successes

4. identifying alternate resources

5. defining/making assignments and committing resources

6. evaluating progress on assignments

7. maintaining a "group" to serve as a coordination interface on Alliance issues
3.38

Alliance Makeup and Structure

1. Jointly establishing regulatory priorities and agenda

The Alliance structure supports consensus and provides an opportunity for all parties to bring their individual ideas, opinions, and input to the table. This creates an open forum for regulatory decision-makers to disucss issues. Presumably, the regulatory decision-makers are aware of federal or state agency radiation control priorities and resources. In an open forum created by the Alliance, all the decision-makers may become aware of pertinent regulatory issues across the nation concerning ionizing radiation (both AEA designated radioactive materials and NARM). As has been the case, issues involving NARM can be of higher priority to the state programs that have authority to regulate those materials than other issues involving AEA-designated materials. By bringing all issues to the table, regulatory priorities, an agenda for resolving them, and suggested regulatory products can truly represent national priorities rather than priorities limited to those radioactive materials that NRC has the authority to regulate. (Regulatory productssuggested may include rules, licensing, inspection, and technical guidance documents, etc.)

Jointly establishing priorities and an agenda does not prohibit regulatory agencies from addressing other issues that are identified. For example, during the 2000 OAS meeting, a group of states representatives volunteered to work together and have developed guidance on positron emission tomography (PET), although it was not identified as one of the top three priorities during the tabletop exercise.

2. Identifying Centers of ExDertise

Using Centers of Expertise to develop regulatory products was identified as an efficient and preferred method during the evaluation of the essential program elements of a National Materials Program. The most up-to-date knowledge and experience involving any one given use of radioactive material does not lie within any one federal or state agency. Since the inception of the Agreement State concept, Agreement State regulatory programs have not only increased in number, but have matured in knowledge and experience with the various uses of radioactive materials. In numerous situations, Agreement States have the most current knowledge and experience because the uses of radioactive material are often concentrated in certain parts of the country. For instance, well-logging and industrial radiography are more unique to the oil-producing states. Regulation of certain radioactive material is located only in Agreement States, as with licensing and inspection of existing waste disposal sites. Agreement States and Non-Agreement States have knowledge, experience, and statutory authority and responsibility that NRC does not have. Therefore, the Centers of Expertise primarily reside at the state level in those situations. The regulatory decision-makers will identify those Centers of Expertise on a nationwide basis for a particular radiation regulatory issue.
3.39

Alliance Makeup and Structure

3. Recognizing current regulatory successes

It is rarely of benefit to "reinvent the wheel" that is turning effectively and efficiently. In

evaluating the program elements, the Working Group determined that the current method of

accomplishing several of the elements was the most effective or was one of several effective

options. Individual agencies, federal or state, have developed alternative methods for

accomplishing program elements. The Alliance allows identification and recognition of current

successes, and ultimately, more efficiently-produced regulatory products.

4. Identifying alternate resources

The Alliance provides an opportunity to create a collection point for alternate resources that can

be used by regulatory agencies. It is not necessary for each federal and state regulatory agency

to produce a regulatory product from scratch. It is inefficient to operate under the presumption

that a regulatory product can only be valid and recognized by regulatory agencies if that product

is initiated, reviewed, and produced by a particular regulatory agency. Federal agencies are

required to use consensus standards, unless other options are justified. State agencies

frequently share regulatory products. Both federal and state regulatory products often reference

other rules and guidance documents, and industry standards. This collection of alternate

resources should include not only regulatory products and consensus standards, but also

professional and industry organizations that can be used in the developing regulatory products.

5. Defininq/making assignments and committing resources

Under the Alliance, groups of regulatory staff members would be assigned to develop a

regulatory product for a particular issue. Membership on those work groups would be made

considering the Centers of Expertise for that particular issue, the availability of staff to participate

on the work group and a regulatory agency's statutory jurisdiction to regulate that particular

issue. Creating these work groups focuses the pertinent national resources for particular issues.

The Alliance establishes work groups and makes assignments. The work groups are also made

cognizant of and should use, where appropriate, the current successes and alternate resources

identified by the Alliance.

Because assignment of federal and/or state personnel to a work group involves a commitment

of resources, those individuals making the assignment must be empowered to commit those

resources. For this and other reasons, the primary membership of the Alliance consists of the

regulatory decision-makers. Whether the committed resources involve money, staff member

time, or both, assignment of such resources is a commitment towards a mutually established

national radiation control priority.
3.40

Alliance Makeup and Structure

6. Evaluating progress on assignments

Progress on those priorities must be evaluated to ensure that the mutually agreed upon national

radiation control priorities are addressed in a timely and appropriate manner. The regulatory decision-makers in the Alliance have committed the appropriate resources and should evaluate

whether the progress is satisfactory or not. For instance, if time lines were established and not

met, the regulatory decision-makers would evaluate the reasons why and make appropriate adjustments to ensure the product is developed and the national radiation control priority is met.

7. Maintaining a "group" to serve as a coordination interface on Alliance issues

Regulatory decision-makers constitute a large group which will require a coordination interface

for communicating within the Alliance. The "interface group" will act as a spokesperson for

Alliance issues. The regulatory decision-makers as a whole will designate the membership "group," which should include representatives from both states and NRC.

Role of the Administrative Core

The Alliance requires an administrative component of the regulatory core. The administrative

component could consist of a few representatives of states and NRC, or could be a separate entity,

as employed by the CRCPD or the Health Physics Society. No decisions or actions on technical or

policy issues or established priorities may be made by the administrative component of the Alliance; this would negate the consensus nature of the Alliance.

The responsibilities of the administrative core within the Alliance include:

1. Planning, coordination and logistics

A support staff function is necessary for Alliance members. The support staff functions must

include coordinating the logistics of Alliance meetings, whether those meetings are physical or

virtual meetings. Meeting locales and reservations must be arranged and notification of the

arrangements must be made to the Alliance members. An agenda for the meeting must be

created and distributed. The support group could provide facilitation for these meetings.

Because the primary membership of the Alliance represents multiple organizations, no one

organization should represent the Alliance. However, the membership of the Alliance, including stakeholders, need a centralized point of contact for logistical purposes.
3.41

Alliance Makeup and Structure

2. Tracking Alliance assignments/products

Regulatory decision-makers are tasked with identifying priorities and making assignments.

Support staff must maintain documentation of those priorities and assignments, including the

desired products, the individuals assigned, and any time lines associated with the assignments.

The administrative core will need access to this information and be able to report to the

regulatory decision-makers who are responsible for evaluating progress.

3. Maintaining Information Infrastructure

The roles of the regulatory decision-makers include identifying Centers of Expertise and

alternative resources and recognizing current successes. The work groups assigned the

development of regulatory products should utilize these Centers of Expertise, alternative

resources, and current successes. An Information Infrastructure provides a centralized point for

collection of this information and any such data collection needs maintenance. Maintenance of

the Information Infrastructure is a support staff function and therefore, a role of the

administrative core of the Alliance.

Role of the Stakeholders

Federal and state agencies must make informed regulatory decisions, and under the Alliance would

still be required to actively seek and consider input from those persons who would be affected.

Stakeholder input would be directed to the Alliance for the regulatory products being developed.

For example, if the Alliance work product were a rule, comments on the rule would be directed to

the work group assigned to the rule. Any comments directed to NRC or an individual state agency

should be forwarded to the work group.

The Alliance in no way negates the opportunity for stakeholders to seek information and provide

input to the NRC or to any individual state agency. Developing regulatory products under the

Alliance allows stakeholders input and access to a larger audience of decision-makers.

Alliance Characteristics and Functions

Although the Alliance is not a structure in itself, it must operate within a framework. It must have

operating procedures in order to function. The framework can vary depending upon the

commitment or resources by those involved.
3.42

Alliance Makeup and Structure

The Alliance can conduct physical or virtual meetings with the decision-makers from all states and

the appropriate managers from NRC. The meetings could be held at an established frequency, such as annually. This provides an opportunity for true consensus because everyone comes to the

table and has opportunity for input. Not all states are expected to fully participate, as is the case

now. Some states may be more active than others.

Instead of having each individual decision-maker present, representatives of the states and NRC

could meet. Decision-makers not present would need to agree to having a representative present their input. It would also require the representative to make greater preparation prior to the meeting by soliciting the opinions and feedback from those decision-makers being represented. From an

operational standpoint, the Alliance would need to determine a method of designating the

representatives. However, representatives will not be able to commit resources on behalf of all

Alliance members. Furthermore, caution would need to be exercised to ensure the consensus of

the Alliance was represented.

Work groups assigned regulatory products by the regulatory decision-makers could consist of

varying combinations of state and NRC staff, depending on the issue and product being developed. The work groups could consist solely of members from interested states, especially for an issue or

product over which NRC has no statutory jurisdiction (non-AEA sources of radiation). Or the work

group could consist solely of NRC staff for an issue or product over which state staff have no

jurisdiction (federal facilities). The work groups could consist solely of Centers of Expertise for a

particular technical issue or could have Centers of Expertise and additional resource members.

The administrative core of the Alliance is a support staff function and can operate in varying ways. It can exist within NRC, in which case, those administrative core members would be federal

employees, specifically NRC employees. They could be located within Office of State and Tribal

Programs because of that program's existing relationship with the Agreement State programs. However, the non-Agreement States are ideally also a part of the Alliance and would need to be

considered. The administrative core functions could be managed by a non-regulatory entity and be

funded through contractual funds, such as the current relationship between the Health Physics Society and Burke and Associates. The administrative core

functions could also be managed through an existing organizational entity such as NRC or

CRCPD's Office of Executive Director, with the addition of FTE(s) and monetary support. The NRC

& CRCPD already perform these functions in support of a national regulatory program. Regardless of how the administrative core is staffed and where it is located, compatible information technology capabilities will be required in order to fulfill the responsibilities of maintaining the Information

Infrastructure and being the central coordination/contact point for the Alliance.
3.43

Alliance Makeup and Structure

Regulatory Process under the Alliance

Work for the Alliance will be done on a voluntary basis. While each agency must develop rules and

guidance based on its own needs, legislation and political necessities, the Alliance will allow

agencies with similar needs to work together cooperatively. When they work together, resources of

staff, money and time are saved.

Under the Alliance, certain fundamental principals will apply for the development of rules and

guidance.

1. Rules and guidance will be developed in partnership using Centers of Expertise.

A standing committee made up of Alliance members - both state and NRC will determine

compatibility.

2. Not all Centers of Expertise may want to participate.

3. Each agency must still meet its administrative procedures for the adoption of rules.

4. The Commission will maintain its role in ensuring the framework for a National Materials

Program through its ultimate adoption of criteria for adequacy and compatibility for rules

The process will be as follows:

1. Alliance meets and establishes priorities.

2. Regulatory change is identified.'

3. Define the work product - e.g., regulation or guidance, scope and depth.

4. Identify Centers of Expertise and establish a working group.

5. Set schedule.

5. The working group drafts the rule, statement of consideration and regulatorv analysis, and

7.

8.

9.

proposes the level of compatibility.

The Alliance's Standing Compatibility Committee assigns compatibility category.

Peer review - Alliance and interested stakeholders.

Working group reviews comments. If major changes to rule are needed, or, if based on

comments, the Working Group believes the proposed compatibility should be changed, the

process goes back to step 6.

I A change may be identified as a national priority, or some states may agree to cooperate on

one of their priorities that did not elevate to a national priority.
3.44

Alliance Makeup and Structure

10. If there are no major changes to the rule and no changes to compatibility, the draft is

distributed to Alliance members, Agreements States and NRC, with a description of changes

since the draft was reviewed.

11. Each agency adopts the rule dependent on desire, internal needs, and compatibility,

pursuant to its own administrative procedures.2

The role of the Alliance will be to:

1. identify priorities (these may be national priorities, or the alliance may facilitate several agencies

working together on priorities that are not elevated to a "national priority"

2. define work product, e.g. rule, guidance or procedure

3. establish the scope, depth and time frame for the product development

4. identify resources needed, e.g. stakeholders, "associates"

The Working Group established to develop the rule Suggested Regulation or guidance will:

1. select a chair(s)

2. develop product

3. report progress

4. have the product peer reviewed and evaluate comments

5. submit the product to the Alliance core

The Alliance's Administrative Core will track and report on the working group's progress, and when

finalized, distribute the product to the Alliance members and the Alliance's Information

Infrastructure.

2 The Working Group proposes that the current 3-year implementation criteria will be continued

under the Alliance.
3.45

Delegated Program

NRC or some other federal entity establishes requirements for licensing and inspection of all radioactive material. States would no longer hold Agreements with NRC, but NRC would be able to delegate certain duties to states. Note that this Option allows for delegation of duties, not authority.

What are the roles/responsibilities NRC is responsible for developing a National Materials Program to meet all

of the NRC for each program program elements.

element?

What is the role/responsibility of an Agreement States would cease to exist. States could contract with NRC to

Agreement State for each program perform some duties from program elements.

element?

Are statutory changes required? The AEA must be amended to include NARM, delete the Agreement State

program, and add provisions to include delegated programs. States may also

need to modify their legislation.

What coordination is required? NRC must coordinate efforts on a national level to ensure no program gaps

are created.

What resources are needed (federal Licensees would pay, and NRC would provide funding to states according to and state)? the terms of each contract.

Who would pay?

Accountability NRC would be accountable to the licensees and the public. States would be

accountable to NRC under the terms of their contracts.

Program Assessment NRC would assess the performance of each state performing delegated duties

at the time of contract renewal at a minimum.

Program Gaps This Option assumes the AEA is amended to include NARM. NRC

essentially has responsibility for regulating all radioactive material in the US

under this Option, therefore eliminating program gaps.
3.46

Delegated Program

Examples of Two Existing Delegated Programs

The Environmental Protection Agency (EPA) currently delegates some of its programs

to states. The Food and DrugAdministration (FDA) also delegates programs under the

Mammography Quality Standards Act (MQSA). The Working Group chose to model the

Delegated Program option after the FDA 's MQSA program because:

1. many of EPA 's delegated programs are split among several different state agencies;

2. MQSA is a radiation protection program and typically resides in the same state

agency as the state 's x-ray program.

Under MQSA, states can sign contracts with FDA to perform inspections for FDA at

facilities performing mammography. These contracts must be reviewed annually. In

exchange, states are provided training, equipment (instruments and phantoms), and

laptop computers for filing inspection reports. States also receive fundsfrom the FDA

for each inspection performed. State personnel inspectfacilities against FDA 's rules

and in accordance with FDA 's procedures. Inspection data are provided to FDA.

FDA is responsible for enforcement and issuance of certificates for mammography

facilities.

The Working Group recognizes that there are many obstacles to implementing this Option;

however, it has been presented as a program that has worked for other federal agencies

and states. The Delegated Program option could be used to supplement the current

Agreement State system and NRC's efforts to verify a consistent approach to regulating

radioactive materials. For example, NRC could contract with states to perform inspections

at VA hospitals or other federal jurisdictions. NRC would retain authority, but in essence,

contract with the states to supplement NRC staff.
3.47

Delegated Program

Advantages

One entity develops and publishes

rules. Rules become more uniform

across the country and the process is

more streamlined. Likewise,

greater consistency in training and

interpretation of rules results. This

especially benefits licensees with

facilities in multiple jurisdictions. Those

companies would hold a single NRC

license for multiple locations in the U.S.

One entity has comprehensive

understanding of the National Materials

Program, and Congress and licensees

may turn to the program when seeking

the national perspective.

A Delegated Program provides an

alternative solution to a funding problem

states experience when they start their

Agreement programs. States wishing to

become Agreement States find it difficult

to get personnel trained and programs

in place once a letter of intent has been

signed by their governor. States have

historically requested funding or"seed

money" to get their programs started.

NRC has not provided such funding in

the past. Under a delegated program

contract for certain types of licensees,

state personnel could be trained by

NRC staff. This could also be used by

NRC as a mechanism for encouraging

states to develop regulatory programs.

Disadvantages

Responsibility for public health and safety related to

radiation control moves from state-level to federallevel. It is unlikely that states would voluntarily give

its authority to a federal entity. States have no

authority to regulate radioactive material within their

borders unless delegated to them.

The number of states signing contracts may vary

from year to year.

A single regulatory entity makes it more difficult to

address regional needs.

Variability in licensing and inspection techniques will

occur. Assessing federal reimbursement to states

for resources used to implement delegated duties

may vary. Variations occur based on the number

and types of licensees and cost of living factors in

different areas of the country.
3.48

Delegated Program

1. Roles and Responsibilities of NRC and States for Each Program Element

A. Performing Materials Licensing (including Sealed Source and Device Reviews, Lowlevel Radioactive Waste, Uranium Recovery, and Decommissioning)

States

States no longer have

authority to license the use of

radioactive materials within

their borders. If a state

participates in a delegated

program for licensing, the state

is required to evaluate

applications in accordance

with NRC's procedures. The

state does not issue state

licenses, but NRC licenses.

NRC

NRC has authority to license all uses of radioactive

material in the U.S. NRC can delegate licensing activities

to states that have requested to participate in such a

program. This delegation may include the entire suite of

licensing activities, or may apply only to certain types of

licenses (such as specifically and generally licensed

gauges).

It would not be cost effective to train staff in three

different states to regulate low-level waste disposal;

therefore, the NRC would probably not delegate these

programs.

It would not be cost effective to train staff in four different

states to regulate uranium recovery facilities; therefore,

the NRC would probably not delegate these programs.

NRC may delegate monitoring of decommissioning

activities and verification surveys at decommissioned

sites; however, final approval of decommissioning is the

responsibility of the NRC.
3.49

Delegated Program

B. Performing Materials Inspections

States

States would no longer have

authority to inspect the use of

radioactive materials within

their borders. If a state

participates in a delegated

program for inspection, the

state must inspect according

to NRC's procedures. The

state would not have any

enforcement authority.

NRC

NRC has the authority to inspect all uses of radioactive

material in the U.S. NRC can delegate inspection

activities to states. This delegation may include the entire

suite of licensed activities, or may apply only to certain

types of licensees (such as specifically and generally licensed gauges).

C. Incidents/Allegations

States

Response to incidents would

be dependent on delegated

authority.

NRC

NRC may delegate the response to incidents within

states, but would probably retain responsibility for

responding to allegations.

D. Materials Licensing Guidance, Inspection Guidance and Rulemaking

States

States would not be required

or allowed to develop guidance

or rules. If a state determined

that guidance was needed,

they must ask NRC to take

action.

NRC

NRC would be responsible for developing and publishing licensing and inspection guidance and rules. NRC may wish to ask states for input on these products, based

upon the state's experience.
3.50

Delegated Program

E. Training, Qualifications and Experience Standards for Regulatory Personnel

States NRC

Each state is responsible for Because NRC has authority to regulate the use of

tracking training their own radioactive material, NRC must ensure staff has received

staff. States must make sure adequate training. This includes NRC staff and staff in

that qualified individuals states with delegated duties as well.

perform delegated activities

under the contract.

2. What are the Roles/Responsibilities of NRC and States in the Current Federal/States

Relationships?

This Option allows for any existing or future federal entity to run a National Materials Program.

The entity is NRC for purposes of this comparison.

The roles of NRC and states changes from co-regulators to an employer/contractor relationship.

NRC, as the federal entity, establishes regulation for the use, storage and transfer of radioactive

material as well as guidance for licensees. NRC has responsibility for performing license

reviews, issuing licenses and performing inspections. States or territories can "contract" with the

NRC to perform license reviews and/or inspections for certain categories of licenses, according

to NRC's procedures. NRC maintains enforcement authority. NRC collects fees from licensees.

States receive training and funding to fulfill terms of the contract. NRC performs activities in

states/jurisdictions that have not assumed delegated duties.

3. Are Statutory Changes Required for this Option?

The AEA would need to be revised to delete Agreement State program authority, and allow

delegated program authority. States may need to modify their legislation in order to participate

in a delegated program. NRC currently regulates only AEA material, but this Option requires

changes to the AEA, and the scope of radioactive materials covered by the AEA could be

modified at that time to include NARM.

4. What Coordination is Required?

Coordination would be needed to make sure states are meeting contract obligations and to

provide instruction to NRC Regions and delegated states.
3.51

Delegated Program

5. Resources Needed and Who Pays?

Licensees would pay fees that would offset the expenses in states with delegated duties. States could try to supplement their contracts by charging fees for duties such as incident response or performing additional inspections when there has been a problem at a facility.

The following table compares the current NRC program resources and NRC resources to be expended if all 50 states participate in a Delegated Program. The estimate assumes 1) states would be responsible for implementing NRC's licensing, inspection and incident response functions, and 2) NRC does not delegate regulatory activities at uranium recovery and low-level radioactive waste facilities.

Figure 3.5 - NRC Resources for Current Program and Delegated Program

Activity Current Current Program Delegated Delegated Program Costs* Program Program Costs* FTE $ in FTE

$ in millions

millions

NMSS, Regions $ 26.6 197 $ 38.7 149

Direct Support** $ 10.0 63 $ 18.8 143

Agency Overhead*** $ 18.4 76 $ 18.5 76

Total $ 55.0 336 $ 76.0 368 Source: NRC's FY 2001 budget - These resource estimates are based upon NRC's FY 2001 budget, and are used as the base case for comparison of the various options throughout this section

* Costs are the sum of contract support, travel costs and staff salaries and benefits.

** These resources include State and Tribal Programs, Materials Research, Incident Response, Enforcement, Investigations, Legal Advice, and Adjudication.

These include indirect resources providing policy, financial, administrative, information technology infrastructure, personnel support, and physical plant support (rent, utilities, building maintenance, etc.).

The changes in FTE from the Current Program in NMSS and the regions are a result of NRC's decreased effort in licensing and inspection activities. The resources necessary to write rules, guidance and procedures would remain the same as the Current Program. Additional resources would be necessary to administer the contracts associated with a delegated program.
3.52

Delegated Program

6. Accountability

NRC would be responsible for making sure that all delegated programs were functioning as

specified in contracts and that the "national" program was meeting the NRC's strategic goals.

7. Program Assessment

Program reviews are conducted and frequency corresponds with the contract expiration date. If

a program has not performed its duties according to the terms of the contract, the contract will

not be renewed. There may be some provisions for terminating a contract if there are significant

health and safety concerns.

8. Program Gaps

If the AEA is amended to incorporate discrete NARM, as recommended by the Working Group

and stakeholders, the Working Group does not envision any program gaps other than the

regulation of diffuse naturally-occurring radioactive material.
3.53

Single Regulatory Agency

A Single Regulatory Authority, NRC, becomes the pre-eminent regulator of radioactive

materials covered under the Atomic Energy Act. NRC seeks authority to regulate NARM

materials in discrete form for a more comprehensive radiation regulatory program as

stakeholders suggested in a meeting in Arlington, Texas.

What are the NRC reassumes regulatory responsibility in former Agreement States and assumes the

roles/responsibilities of the role as the single regulator for all radioactive material. This Option assumes NRC

NRC for each program obtains authority for NARM. NRC interacts primarily only with its licensees and

element? stakeholders. There would be few direct interactions with states or state organizations

over regulatory issues.

What are the States have no regulatory responsibility for radioactive materials. They retain

roles/responsibilities of an responsibility for regulating other sources of ionizing radiation.

Agreement State for each

program element?

Are statutory changes Yes, the Agreement State Program must be eliminated from the AEA. Agreements required? need to be abrogated on a individual basis. NRC would need NARM authority to

establish a comprehensive national materials program. States need to enact legislation

to exclude AEA and NARM, yet retain authority for other sources of radiation.

What coordination is An extensive federal and state effort is necessary to revise AEA. Substantial

required? stakeholder involvement is required at both state and federal levels. An equally

extensive effort is needed to abrogate each agreement under revised statutes and to

convert state licenses to NRC licenses.

What resources are needed Present and future NRC licensees pay all program costs.

(federal and state)? The significant heavy cost of conversion becomes an "equity issue" for present NRC

Who would pay? licensees. New licensees coming under NRC's regulatory authority could object to

paying for the transition.

NRC would also fully fund infrastructure to support its national program. States pay

nothing, except for their costs to change legislation and terminate agreements.

Accountability NRC accountability is similar to the Current Program. State accountability is similar

to the Current Program, but only for diffuse naturally-occurring radioactive material.

Program Assessment NRC needs to develop a new assessment program that would focus its evaluation on

regional activities. IMPEP could be used as a model.

Program Gaps AEA would need to be amended to include NARM. The only gap regarding

radioactive materials would be diffuse NORM.
3.54

Single Regulatory Agency

Advantages

If NRC has authority to regulate NARM,

it provides an immediate framework for

a centralized National Materials

Program.

In a centralized operation, the

rulemaking, policy, guidance and

decision making process would be less

encumbered. NRC would not have to

rely upon, or ask for states opinions or

take into account their regulatory

experience when conducting business.

NRC would only have to be responsive

to stakeholders, standards development

organizations and the public.

While little direct savings would accrue

from this "improved" process, states

would no longer participate, thus saving

some time and effort. The issue of

compatibility of rules would be moot; the

only applicable rules would be those

enacted by NRC.

Disadvantages

To maintain an effective program and provide

reasonable service to its stakeholders, NRC would

need to redesign its existing structure.

NRC will take regulatory authority over

approximately 15,000 licensees in the continental

United States. In the mid-1990's, when NRC

licensed approximately 6- 7,000 licensees, NRC

decreased from five Regions to four to

accommodate a changing business environment. As

the Single Regulatory Agency, NRC must devise

ways to service the additional territory and licensees

from the former Agreement States. Agreement

States currently regulate about three times as many

licensees as NRC (15,000 to 5,000). One option for

NRC is to increase the number of Regional offices.

Another set of options, such as the use of satellite

offices, or extensive work-at-home arrangements

could be employed. Another idea, expressed by one

stakeholder, would be to establish an NRC office in

each State. The administrative costs for such a

large organization would be much more expensive

than the Current Program.

NRC would be faced with an immediate need to

increase the size of its management, professional

and support staff and infrastructure. Cost of initial

efforts are expected to be proportional to the

number of existing licensees.

The extensive Agreement State knowledge base

would be quickly dissipated and lost with this Option.
3.55

Single Regulatory Agency

Advantges - cont'd

A stakeholder pointed out that having

a single license issued by a national

entity would be preferable to the

present system where a licensee has

to have several licenses or have

reciprocity recognition from different

regulators. Manufacturers and

distributors of sources and devices

expect positive benefits because only

one license would be required.

Reconsolidating NRC's regulatory authority and including NARM could

improve a discordant business

environment, especially businesses

whose activities cross regulatory

boundaries.

Disadvantages - cont'd

Some state programs are heavily subsidized by state

general revenue funds. If the cost of a reunified

program is passed on to those licensees, they may actually see an increase in fees.

Stakeholders believe that the cost of

business would be lower and more

consistent if radiation regulatory

activities were administered by a

single regulator. On average, the

costs to licensees would decrease due

to an economy of scale. Costs of a reunified regulatory program would be

shared by a much larger licensee

base.

Additional cost savings would be

realized only for states in the areas of

rulemaking, guidance and policy

because single, national rules,

guidance and policy would need to be

developed instead of those for 32

individual states.
3.56

Single Regulatory Agency

1. Roles and Responsibilities of NRC and States for Each Program Element

Under this Option, only NRC has responsibility for addressing radiation protection program

elements. There would be no change from NRC's current procedures, but there would be

significant changes to the size of NRC's program.

NRC's role and responsibility remains the same as it was prior to the amendment of the AEA

that permitted the development of Agreement States. Currently, NRC has relinquished its

regulatory authority in 32 states. The change from the current program to a Single Regulatory

Agency could be made voluntarily or required by legislation.

2. Are Statutory Changes Required for this Option?

A revision of the AEA to eliminate the Agreement State Program and for NRC to assume

responsibility for regulating discrete NARM sources would be needed.

To terminate the Agreement State program through legislation, Congress would need to amend

the AEA. NRC would abrogate the existing agreements, thus restoring NRC as the single

regulator for AEA materials. Some states could object to any change to the AEA that would

eliminate what they believe to be their highly successful state run radiation protection programs.

Although some states favor having NRC assume control over discrete NARM to further the

development and consistency of a National Materials Program, this belief may not be universally

held. Some Agreement States believe that they are already regulating both AEA and NARM in a

consistent manner. What is needed, they believe, is for a more comprehensive process that

would regulate similar risks from dissimilar materials in a like manner.

3. What Coordination is Required?

To voluntarily reassume its role, NRC would cancel its existing agreement with each Agreement

State, likely spending considerable time and funds explaining the need to reverse the current

program. NRC would need to obtain some form of consensus among the states, business, and

the public. Thereafter, a smooth transition would result only if all existing Agreement States

would readily agree to abandon each of their agreements with NRC. Should one or more

Agreement States disagree with NRC's proposal, legal action would be likely. An individual state

or a group of states could sue to prevent NRC's proposed change in the Agreement State

program. The result would be a period of disharmony not conducive to operating an effective

regulatory program.
3.57

Single Regulatory Agency

4. Resources Needed and Who Pays?

NRC licensees will fully fund the program unless Congress authorizes greater "off fee base"

funding for certain aspects of a National Materials Program. Former Agreement States will have

no responsibility for operating or funding a regulatory program. Although costs of the larger, nationalized program would be shared among the larger licensee base, it is unlikely that the

licensees would see a marked decrease in fees from the present level. It's equally likely that

fees may increase substantially. Increases would be needed to increase infrastructure and

staffing, train more staff in licensing and inspection, increase management to support the

increase in staff, and the increased costs for renting, leasing or buying more facilities to support

a presence throughout the U.S. These increases could be necessary to support NRC in

assuming authority for licensees formerly under Agreement State control.

For former Agreement State licensees, little change may occur because states tend to include

NARM and AEA materials under a single license.

A Single Regulatory Agency assumes that NRC would implement a program sufficient to

regulate all radioactive material in the US. The total number of AEA materials licenses in the US

is approximately 20,000. NRC's current resources in the materials arena would need to

increase fourfold. Costs for regulating discrete NARM have not been included in these

estimates because the bulk of the impact is in the increase in number of licenses from

Agreement States, and those licenses treat NARM and AEA material in a similar manner. NRC

resource implications are given in Figure 3.6 on the following page.
3.58

Single Regulatory Agency

1111111-

Figure 3.6 - NRC Resources for Current Program and Single Regulatory Entity

Activity Current Current Single Single

Costs* Costs* Regulatory Regulatory

$ in million FTE Costs* Costs*

$ in million FTE

NMSS, Regions $ 26.6 197 $ 57.4 456

Direct Support** $10.0 63 $ 14.8 120

Overhead*** $ 18.4 76 $40.8 168

Total $ 55.0 336 $113.0 744

* These resource estimates are based on NRC's FY 2001 budget and used as the

base case for comparison of the various options throughout this section.

Costs are the sum of contract support, travel costs and staff salaries and benefits.

** Resources include State and Tribal Programs, Materials Research, Incident Response,

Enforcement, Investigations, Legal Advice, and Adjudication.

Resources include indirect resources providing policy, financial, administrative, information

technology infrastructure, personnel support, and physical plant support (rent, utilities,

building maintenance, etc.).

5. Accountability

NRC would be accountible for all radioactive material uses in the United States. States would

only be accountable for other ionizing radiation.

6. Program Assessment

Agreement States would not exist as NRC assumed its prior authority; therefore, program

assessment is not required under this option. NRC may, if it chooses to do so, institute a selfassessment of programs and quality assurance to assure consistency between its offices

nationwide.

7. Program Gaps

If NRC assumes responsibility for NARM, most gaps in a National Materials Program are

eliminated.
4.1

SECTION IV

I

The Working Group recommends a structural option for implementing a National Materials Program and four components for a National Materials Program.

Adopt the Alliance Option

and Develop an Implementation Plan

and

Use Centers of Expertise Seek Authority to Regulate NARM

Maintain an Information Infrastructure

Create a Standing Compatibility Committee
4.2

Recommendations for a National Materials Program

The Working Group recommends the Alliance as a structure for a National

Materials Program

Adopt the Alliance Option

and Develop an Implementation Plan

The Working Group recommends that the Commission adopt the Alliance Option as a

sound basis for achieving its strategic goals, maintaining a national presence, and

meeting the objectives of a National Materials Program as the NRC enters into more

agreements with states. The Alliance Option is a flexible structure that permits "task

organization" of national resources and expertise to quickly address any future health

and safety issue.

An Implementation Plan should also be developed and used to ensure that the

Commission's recommendations are fully enacted. Due to the significant changes

involved in using the Alliance Option as the approach to a National Materials Program,

the Commission will need to give the staff strong, clear direction for implementation.

The Working Group recommends development of an Implementation Plan, regardless

of the option the Commission chooses.
4.3

The Alliance as a National Materials Program

The Working Group recommends the Alliance Option based on numerous advantages,

cost savings, and enhanced ability to share expertise.

Advantages and

Justifications

for the Alliance Option

* best suited for essential

development of common

goals and objectives, joint

decision-making, shared

resources and responsibilities

- greatest potential to achieve

on a national level the goals

in NRC's strategic plan

* highest rank in the

analytical criteria used to

evaluate the six options for a

National Materials Program

Recommendation

The Working Group has determined through its

evaluations that the Alliance Option provides the most

assurances for meeting the needs of NRC, states, and a

National Materials Program.

Strengths of the Alliance Option

The Alliance takes advantage of the many positive

features found in the current program, which already

enjoys a high level of familiarity and acceptance among

regulators, licensees, stakeholders, and the public.

The Alliance Option leverages the collective experience

and expertise of all stakeholders to accomplish the

common goals, meet national priorities and schedules,

and maintain an infrastructure essential to protect public

health and safety.

The Alliance Option's flexible structure permits "task

organization" of national resources and expertise to

quickly address any future health and safety issue.

Rank Compared to Other Options

In order to assure it did not bias its recommendations,

the Working Group also used a well proven analytical

method, the relative value decision matrix, to evaluate

the six options presented in Section III. The matrix

helps ensure bias and subjectivity are minimized in the

decision process; it is widely used in business and the

military.

The results of the matrix analysis indicate that the

Alliance Option is most consistent with the objectives

of a National Materials Program. See Figure 4.1 on the

following page. A description of the decision matrix

and how it operates are found in Appendix D.
4.4

Relative Value Decision Matrix

The Working Group used the matrix to further analyze its recommendations.

The relative value decision matrix technique was used to mathematically analyze the options considered by the Working Group. This tool objectively analyzes the six options considered in

Section III and reduces the subjectivity errors that occur when several options are simultaneously considered. The eight Evaluation Criteria are based on NRC's strategic goals, and the objectives of a National Materials Program previously identified by the Working Group.

Figure 4.1 - Evaluation of National Materials Program Options

Weight 4.68 2.06 1.04 1.04 1.04 1.04 1.00 1.04 Total

Evaluation Criteria Maintains Optimize Promote Account Flexibility Exchange Harmonize Public Safety Resources Consensus for of Regulatory Confidence

Individual Information Approaches Program

Needs

Options

Current 

(Base 

Program 4 3 2 3 3 4 4 2 44 Case)

Minimum 

Involvement

NRC 5 5 3 4 4 5.5 5 4 60

Independent States 6 6 5 1 1 5.5 6 5.5 65

Delegated Program 2 4 5 5 5 2 2 3 41

Alliance 2 1.5 1 2 2 3 2 1 24

Single 

Agency 

Regulatory 2 1.5 5 6 6 1 2 5.5 39 IIII

Relative Values Matrix (Less is Better)

Consistency Ratio = 99.28%
4.5

Costs Savings with the Alliance Option

The Working Group believes the Alliance Option will best use existing

resources.

Cost Savings

The Working Group believes that with the Alliance

Option, some cost savings will be realized for both

Two NRC factors NRC and Agreement States because it creates an

greatly influence improved process for rulemaking, rule reviews,

costs in the current compatibility determinations, and developing common

a pregulatory products. Actual savings depend on the level

materials program: of participation in the development of regulatory

* policy decisions products.

* degree or The Alliance Option spreads the responsibility for

intensity of how determining the direction and focus of a National

policies are Materials Program among a wider group of participants.

implemented This provides two advantages which should result in

cost savings. The Alliance allows participants to:

1. affect policy decisions that direct the National

Materials Program, and

2. control the degree or intensity of individual program

participation.

The Alliance also offers the flexibility to use existing

resources in a more focused manner. The Alliance

Option offers the best opportunity for NRC to

economically continue as a significant player in a

National Materials Program as more and more states

become Agreement States.
4.6

Assumptions Regarding the Alliance Option

The Working Group recommends the Alliance Option with the assumption that expertise

and responsibilities will shift

Assumptions Necessary for Success

1. States develop and maintain a level of technical

and regulatory expertise at least equal to, or

The Alliance Option greater than, that of NRC.

is a necessary and 2. The federal government transfers regulatory

practical solution to authority to states competent in developing and

the issues NRC faces organizing programs that are adequate to protect with the continued workers and the public.

growth in the number

of Agreement States These assumption are in keeping with the trend that of Agreement Stbegan in 1971 with the number of licensees regulated and declining by Agreement States exceeding the number of NRC

licensee base. licensees. As states gain expertise and statutory

authority, the federal agency transfers authority.

As more states become Agreement States, states will

regulate even larger numbers of licensees. This will

require states to develop and maintain more regulatory

and technical expertise to meet emerging technologies.

With fewer licensees and fewer types of uses of

radioactive materials, it may become difficult for NRC

to maintain an awareness of current and emerging

technologies and to develop appropriate regulatory

responses unless it significantly changes the way it

interfaces with its stakeholders, the states, and the

public. The experience base in many technical areas

now lies outside NRC.

The Alliance Option offers the prospect of leveraging

NRC's program by joining in a continuing collaborative

process with other regulators. The process would

jointly establish national priorities and agendas, share

resources, and develop common regulatory products.
4.7

Recommendations for a National Materials Program

The Working Group recommends these components of a National Materials Program for

Commission consideration.

The Working Group identified four components of a National Materials Program it

believes the Commission should adopt. The Alliance is the structural option that most

effectively incorporates these four components. However, the Working Group believes

that these components should be adopted regardless of the option or combination of

options the Commission chooses for the structure of the National Materials Program.

Each of these components is discussed in greater detail in Section V.

Use Centers of Expertise

Seek Authority to Regulate

NARM

Maintain an Information

Infrastructure

Create a Standing

Compatibility Committee

This concept optimizes resources of federal, state,

professional, and industrial organizations and

reduces duplicate efforts.

Radioactive material is not regulated consistently

on a national basis. The Working Group is aware

that NRC is currently evaluating the issues

involved with seeking authority to regulate NARM.

In order to create consistency nationwide, the AEA

would ideally authorize the regulation of NARM.

An information infrastructure would maximize the

sharing of information and resources. Such a

clearinghouse would consolidate resources,

reduce duplication, promote Centers of Expertise,

and provide alternative resources to stakeholders

in a timely manner.

The Standing Compatibility Committee would

consist of individuals who would not be directly

involved in the development of a rule. The

compatibility recommendations to the Commission

would then represent a broader range of input and

would provide consistency in designating

compatibility levels across the range of rules.
5.1

SECTION V

In Section V, the Working Group explains in further detail the four

components of the National Materials Program recommended in

Section IV. These components are most effectively incorporated in the

Alliance Option, but should be considered regardless of the option or

combination of options chosen for a National Materials Program.

* Use of Centers of Expertise

* Seek Authority to Regulate NARM

* Maintain an Information Infrastructure

* Create a Standing Compatibility Committee
5.2

Use Centers of Expertise

Using Centers of Expertise optimizes resources.

Centers of Expertise

Centers of Centers of Expertise are an integral component of Centier the recommended Alliance Option for the National ExpMaterials Program. The Centers of Expertise

Regardless of concept optimizes resources of federal, state, R egardle or notprofessional, and industrial organizations and whether or not the reduces duplicate efforts.

Alliance Option is

adopted, the Some Agreement States and NRC regions have,

Centers of over time, developed considerable experience and

Expertise concept expertise with specific uses of radioactive

should be materials. Examples of areas of expertise include

implemented in a well logging, industrial radiography, positron

National Materials emission tomography, and intravascular

Program. brachytherapy. Agreement States and NRC regions

that have developed expertise in specific uses

should be identified and used as a resource by other

regulatory programs. These Centers of Expertise

may change over time as others develop expertise.

A specific process for identifying and utilizing

Centers of Expertise should be developed in the

implementation plan for the National Materials

Program.
5.3

Seek Authority to Regulate NARM

NRC should seek legislative authority to regulate discrete sources of NARM.

Regulation of NARM

The Working Group recommends that the NRC seek

Inconsistency in legislative authority to regulate discrete sources of NARM.

NARM Regulation This does not include diffuse naturally-occurring radioactive

material.

A fragmented

regulatory scheme Variations in Regulation of NARM

treats similar

radioactive materials The Working Group recognizes that radioactive material is

(and in some cases the not regulated consistently on a national basis. NARM

same radioisotope) oversight varies among states, and in some states, the

differently based on oversight is not based on risk.

how the material is Some non-Agreement States license and inspect NARM

produced. Wide similarly to the oversight provided by NRC and Agreement

disparities in the way States.

materials are regulated

exist among states, Some non-Agreement States only register NARM sources

although the risks of and may not conduct any inspections.

the materials are the

same. This is NRC regulation of NARM would meet three of NRC's

inconsistent with the strategic goals by:

concept and goals of a

National Materials * maintaining public health and safety through National Mestablishment of a regulatory oversight framework that

Program. ensures that materials licensees continue to conduct

activities involving the use of radioactive materials in a

safe manner;

* improving the effectiveness of regulatory programs

nationwide; and

* reducing unnecessary regulatory burden.

The Working Group understands that NRC is currently looking into the issue of

regulation of NARM, and believes in an ideal situation, the AEA would authorize the

regulation of all NARM. However, it may be more practical for NRC to seek authority

for only discrete NARM sources.
5.4

Seek Authority to Regulate NARM - cont'd

Regulation of NARM by NRC would require startup resources and ongoing costs,

both believed to be minor in relation to the overallprogram.

If granted Resources

statutory The Working Group considered resources when determining authority, NRC the relative value of regulating NARM. See Appendix C. could begin to Regulation of NARM by NRC would require startup regulate NARM without resources, but the Working Group does not believe these

hou snif sig t will be significant. The ongoing cost of regulating discrete ican NARM is predicted to be minor in relation to the overall

existing rules and program, as is the case in Agreement States.

guidance. Impacts on NRC

The Working Group believes regulating NARM will have

limited impacts on NRC.

NRC for the most part already licenses the same type of

The Chair of the activities with AEA materials. For uses of radioactive S imaterials QAS for which NRC does not have a history, they can Informally look to the Centers of Expertise - those states that already asked Agreement license NARM.

State and nonAgreement State Cost Savings

managers and staff There would be a potential resource saving for some about their licensees and for some non-Agreement States, as most opinions on NRC NARM licensees also have an NRC license. Elimination of licensing NARM. dual regulation would result in savings to the licensee and to

the state. A consequence of including NARM in the Of those program materials regulated by NRC could be the dissolution of

managers who some non-Agreement State radioactive materials programs responded, unless the option encouraged or forced non-Agreement most favored States to seek Agreement State status.

regulation of NARM in the National Materials Program NARM by NRC, but The Working Group recognizes that not all states will want

were concerned NRC to seek this new authority. However, a true National

about compatibility Materials Program must be based on risk and must maintain

issues. safety, improve effectiveness, and reduce regulatory

burdens. A nationally uniform process that regulates similar

risks from similar radioactive materials in a consistent

manner will best assure this.
5.5

Maintain an Information Infrastructure

Mechanisms for an Information Infrastructure and a new Working Group are recommended

The National Materials Program Working Group recommends that a new Working Group be established.

The task of this group would be to further define the Information Infrastructure necessary to support the

existing nationwide regulatory structure program or any option or combination of options the

Commission chooses.

Information Infrastructure

An Information Infrastructure, or clearinghouse, could include

Create an rules, guidance documents, forms, industry and professional

Information standards, incidents and events (for tracking performance and

Infrastructure that identification of generic safety issues), numbers and types of

would consolidate licensees for regulatory agencies, sealed source and device

resources, reduce registration sheets, escalated enforcement actions, certification,

duplication, personnel directory information, services (waste brokers,

promote Centers recycling), program information, training, etc. The distribution

of Expertise, and can be either active, as in visiting a website, or passive, as when

provide alternative information is automatically distributed to users.

resources to On-Line Resources

stakeholders in a Many regulatory agencies have statutes, rules, and other

timely manner. information on-line. Some states and NRC also have policies,

procedures, and guidance on-line. CRCPD maintains lists of

contacts for a wide variety of radiological assistance and

technical information at its website. Professional organizations

Develop and maintain on-line resources. NRC also maintains several

share on-line specialized national databases on-line, such as the Nuclear

information and Materials Events Database and the Sealed Source & Device

resources Registry. Over time, experienced stakeholders have learned what

essential to a information is available and where to locate it. No on-line

National mechanism exists to make it easy to identify, collect, access, or

Materials distribute relevant information from the many sources.

Program. The Working Group suggests that NRC should continue to

maintain and improve current on-line resources and should seek

methods and technology to include, link to, or search other online resources and information. State radiation control programs

should also link to the NRC's web pages.

The working group believes that information requirements should be

determined by consensus, with the NRC serving as a center of activity in the

area of information distribution. NRC has demonstrated experience in

developing and maintaining this vast amount of information on-line.
5.6

Create a Standing Compatibility Committee

A Standing Compatibility Committee will improve the compatibility determination

process.

Recommendations:

* A Standing Compatibility

Committee should consist of

individuals representing both NRC

and Agreement States.

* Individuals should be

specifically trained in making

compatibility determinations

based on the principles of the 1997

Compatibility Working Group.

* In order to maintain objectivity,

Committee members should not

be directly involved in the

development of the particular rule

being evaluated for compatibility

designations.

* The Standing Compatibility

Committee should establish the

recommended compatibility levels

using Management Directive 5.9.

* Committee recommendations for

each rule should be presented to

the Commission when the rule is

presented.

Standing Compatibility Committee

A Standing Compatibility Committee could enhance

the existing compatibility determination process. Such

a committee offers these benefits:

* Membership would represent a broader range of

input by including others in addition to NRC staff.

* Membership would provide consistency in

designating compatibility levels across the range of

rules.

This concept of a Standing Compatibility Committee

is consistent with the objectives of a National

Materials Program.

Current Process

NRC determines compatibility using Management

Directive 5.9, adopted in February 1998. This

directive outlines the process by which compatibility

recommendations are currently made. Unless statutes

are changed, the Commission will continue to have

responsibility to establish compatibility for rules.

Beginning in 1995, a Compatibility Working Group of

Agreement State and NRC representatives evaluated

the level of compatibility of NRC rules. Most states

believed the results of this compatibility review were

valuable. However, since that time, NRC has been

making compatibility decisions, with some

disagreement between NRC and states resulting.
5.7

Create a Standing Compatibility Committee - cont'd

A Standing Compatibility Committee will provide a broader range of input, consistency in

designating compatibility levels, and increased objectivity.

Disagreements Concerning Compatibility

Some states believe the understandings and the

Criteria exist for intent of the compatibility review group have

determining compatibility not been strictly followed. They believe that

requirements. However, NRC has inadvertently misapplied the intent of

states believe that the Management Directive 5.9. This could occur,

criteria have been for instance, if an individual who drafted a rule

misapplied in some elevated the compatibility level for that rule

instances. A Standing beyond the level an objective and impartial

Compatibility Committee reviewer would designate.

could remedy this

situation. Some in the Agreement States believe the

misapplications of the intent of Management

Directive 5.9 are demonstrated by the excessive

use of compatibility category H&S (Health and

Under the Alliance Safety). A number of rules that otherwise have

Option, rules may be a compatibility category of D have been also

developed by Centers of designated as H&S. This designation then

Expertise. These centers requires the Agreement States to adopt a rule

may consist primarily or they might otherwise not have a need to adopt.

solely of Agreement The following rules in 10 CFR are offered as

State and/or non- examples:

Agreement State staff - 20.1101(b)

members. A Standing - 20.1501(a)(2)(i)

Compatibility Committee - 20.1502

would provide - 20.1906(d)

consistency in

compatibility Benefits

determinations. A standing compatibility committee would

serve to minimize disagreement and would

optimize resources by providing consistency.
6.1

Section VI

In Section VI, the Working Group specifically responds to each of the six

directives from SECY-99-250.
6.2

Responses to SECY-99-250 Directives

SECY-99-250 directed the Working Group to respond to six issues.

When the Commission established the National Materials Program Working Group in SECY-99-

250, it indicated that the following six issues were key to defining and implementing future state

and federal roles under a National Materials Program and should be addressed by the Working Group's report. The Working Group's response to each of the directives follows.

1. Development of an overall program mission statement with defined top level

goals and objectives.

Mission The mission of a National Materials Program is to provide a coherent national

framework for the regulation of hazards associated with radioactive material.

Goal Protection of public health and safety while effectively using regulatory

resources.

Obiectives * Optimize resources of federal, state, professional, and industrial

organizations

* Account for individual agency needs and abilities

* Promote consensus on regulatory priorities

* Promote consistent exchange of information

* Harmonize regulatory approaches

* Recognize state and federal needs for flexibility

2. Delineation of the respective roles and legal responsibilities of NRC and the

Agreement States, including OAS and CRCPD.

The roles and responsibilities of NRC, Agreement States, and other organizations will vary depending on the option or combination of options chosen by the Commission.

Under the recommended Alliance Option, NRC and Agreement States will function as

partners. The roles and responsibilities of NRC and states will be based on their program needs and expertise. There would be no changes to legal responsibilities, except for the

acquisition by NRC of the authority to regulate discrete NARM.

Adoption of the Alliance Option could serve as the framework for participation and

involvement of other stakeholders, including OAS, CRCPD, HPS, and standards developing organizations.
6.3

Responses to SECY-99-250 Directives - cont'd

SECY-99-250 directed the Working Group to respond to six issues.

3. Delineation of the scope of activities to be covered by the program and the

need for statutory changes at both state and federal levels.

In order to establish a comprehensive national regulatory program, discrete NARM would be

regulated similarly to AEA materials, which would require statutory authorization.

Under an Alliance, the scope of types of activities performed by the NRC and states would

remain essentially the same, but the intensity of those activities may vary.

4. Establishment of formal program coordination mechanisms.

An Alliance consists of regulatory decision-makers from state and NRC program managers,

an administrative core to coordinate and provide logistical support, and stakeholders to

provide information and support to the Alliance.

The Alliance would be a structure through which national program goals and objectives are

established and resources are coordinated to implement those goals and objectives.

5. Establishment of performance indicators and a program assessment process

to both measure program performance and to ensure program evolution.

The Integrated Materials Performance Evaluation Program (IMPEP), which is designed to

assess individual regulatory programs, should be retained.

In addition, the Alliance should develop a National Materials Program assessment process

using IMPEP-type principals to evaluate at least the following nationwide program

indicators.

* Meet strategic health and safety goals

* Decrease time to develop regulatory products

* Increase participation by state programs in development of regulatory products

* Decrease the time for implementation of rules nationwide

* Decrease resources necessary for development of regulatory products

* Evaluate participation by licensees, stakeholders and other federal agencies in the

development of regulatory products

* Maintain an adequate Information Infrastructure.
6.4

Responses to SECY-99-250 Directives - cont'd

SECY-99-250 directed the Working Group to respond to six issues.

6. Provision/budgeting of resources at both state and federal levels.

Resource implications for NRC are included in the discussion of the Alliance Option in Section 111. The resource needs are dependent upon the intensity of NRC's involvement in

a National Materials Program. Overall, an Alliance would provide for better utilization of existing resources at both the state and federal level.
, - -National Materials Program

Appendices :

Final Report of the Working Group

SECY 99-250

Volume II

May 2001
National Materials Program

Appendices

Final Report of the Working Group

SECY 99-250

Volume II

May 2001
National Materials Program

Working Group Report

examines

* impacts of increasing number ofAgreement States

* six optionsfor a National Materials Program structure

and

* the following six issues as specifled in SECY-99-250

Development of an overall program mission statement with defined

top level goals and objectives.

Delineation of the respective roles and legal responsibilities of

NRC and the Agreement States, including the Organization of

Agreement States and the Conference of Radiation Control

Program Directors, Inc.

Delineation of the scope of activities to be covered by the program

and the need for statutory changes at both state and federal levels.

Establishment of formal program coordination mechanisms.

Establishment of performance indicators and a program assessment

process to both measure program performance and to ensure

program evolution.

Provision/budgeting of resources at both state and federal levels.
iii

National Materials Program

Working Group Members

Kathy Allen, Co-Chair

Jim Myers, Co-Chair

Fred Combs, Advisor

Carol Abbott

Chip Cameron

Cindy Cardwell

Joe DeCicco

Elizabeth Drinnon

Tom Hill

Linda Howell

Jake Jacobi

Bob Walker

Duncan White

Illinois Department of Nuclear Safety U.S. Nuclear Regulatory Commission

U.S. Nuclear Regulatory Commission

U.S. Nuclear Regulatory Commission

U.S. Nuclear Regulatory Commission

Texas Department of Health

U.S. Nuclear Regulatory Commission

Georgia Department of Natural Resources

Georgia Department of Natural Resources

U.S. Nuclear Regulatory Commission, Region IV Colorado Department of Public Health and

Environment

Massachusetts Department of Public Health

U.S. Nuclear Regulatory Commission, Region I

Special Assistance From:

Charlie Cox

Jim Lieberman

Hampton Newsome

Brooke Poole

U.S. Nuclear Regulatory Commission

U.S. Nuclear Regulatory Commission

U.S. Nuclear Regulatory Commission

U.S. Nuclear Regulatory Commission

Steering Committee Members

Carl Paperiello, Chair

Edgar Bailey

Douglas Collins

Donald Cool

Jesse Funches

Joseph Gray

Robert Hallisey

William Kane

Paul Lohaus

Cynthia Pederson

Martin Virgilio*

U.S. Nuclear Regulatory Commission

California Department of Health Services

U.S. Nuclear Regulatory Commission, Region 11 U.S. Nuclear Regulatory Commission

U.S. Nuclear Regulatory Commission

U.S. Nuclear Regulatory Commission

Massachusetts Department of Public Health

U.S. Nuclear Regulatory Commission

U.S. Nuclear Regulatory Commission

U.S. Nuclear Regulatory Commission, Region Ill U.S. Nuclear Regulatory Commission

(*replaced William Kane)
iv

Table of Contents

Volume Two

SECTION VII ....................................................... 7.1

Acronyms Appearing in the Appendices ......... ....................... 7.2 A. Directives and References .......... ......................... 7.4 National Materials Program Working Group Charter .... ........ 7.5 National Materials Program Secy-99-250 ..................... 7.6 Section 274 of the Atomic Energy Act ....................... 7.8 B. Working Group Interactions and Communications ..... .......... 7.14 Communication Plan ..................................... 7.15 Meetings and Outreach Activities of the Working Group ....... 7.22 Questions and Comments from NRC Staff ..... ............. 7.24 Responses to Stakeholder Questions at NERHC Meeting ...... 7.26 Input from Health Physics Society Focus Groups ..... ........ 7.30 South Texas Chapter of the Health Physics Society ...... 7.30

Atlanta Chapter of the Health Physics Society .... ...... 7.35

New Jersey Chapter Health Physics Society .... ........ 7.38 C. Evaluation of Program Elements .7.41

Summary of Program Element Evaluations .7.42

Materials Licensing Guidance .7.48

Materials Inspection Guidance .7.49

Materials Licensing and Inspection .7.50

Performing Materials Inspection .7.51

Reciprocity. 7.55

Technical Guidance Documents .7.56

Training, Qualifications & Experience Standards .7.57

Regulatory Program Reviews .7.58

Regulatory Program for General Licensees - Regulatory Agency .7.59

Regulatory Program for General Licensees - Implementation .7.60

Certification Programs .7.61

Rulemaking .7.62

Information Infrastructure .7.64

Incident/Event Response .7.66

Generic Assessment for Events .7.68

Materials Research .7.70

D. Relative Decision Matrix ..................... 7.71
V

Table of Contents - cont'd

Volume Two

SECTION VIII ............. 8.1 Bibliography ............. 8.1
7.1

SECTION VII

1

Appendices

Section VII contains the reference materials and detailed appendices supporting the explanations in the text of the report.
7.2

APPENDIX A

Acronyms Appearing in the Appendices

AEA Atomic Energy Act

AEC Atomic Energy Commission

AMA American Medical Association

ANSI American National Standards

Institute

AS Agreement States

ASME American Society of Mechanical

Engineering

ANSI American National Standards

Institute

ASNT American Society of

Nondestructive Testing

CDC Centers for Disease Control

CRCPD Conference of Radiation Control

Program Directors, Inc.

DOE U.S. Department of Energy

DOI U.S. Department of Interior

DOL U.S. Department of Labor

DOT U.S. Department of

Transportation

EDO NRC Executive Director of

Operations

EPA U.S. Environmental Protection

Agency

FDA U.S. Food and Drug

Administration

FTE Full-Time Equivalent

HPS Health Physics Society

HQ NRC Headquarters

IAEA International Atomic Energy

Agency

IMC Inspection Manual Chapter

IMNS NRC Division of Industrial and

Medical Nuclear Safety

IMPEP Integrated Materials

Performance Evaluation

Program

ICRP International Commission on

Radiological Protection

MARSSIM Multi-Agency Radiation Survey

and Site Investigation Manual

MQSA Mammography Quality

Standards Act

MSHA U.S. Mine Safety and Health

Administration

NARM Naturally Occurring and

Accelerator Produced

Radioactive Material

NAS National Academy of Sciences

NCRP National Council on Radiation

Protection

NEI Nuclear Energy Institute

NERHC New England Radiological

Health Committee

NESHAPS National Emission Standards for

Hazardous Air Pollutants

NIST National Institute of Standards

and Testing

NMA National Mining Association

NMED Nuclear Materials Events

Database

NMP National Materials Program

NMPWG National Materials Program

Working Group

NMSS NRC Office of Nuclear Materials

Safety and Safeguards

NORM Naturally Occurring Radioactive

Material

NOV Notice of Violation

NRC U.S. Nuclear Regulatory

Commission

OAS Organization of Agreement

States

OGC NRC Office of General Counsel

OMB Office of Management and

Budget

OSHA U.S. Occupational Safety and

Health Administration

OSTP NRC Office of State and Tribal

Programs

PET Positron Emission Tomography

RSO Radiation Safety Officer

SDO Standards Developing

Organization

SNM Society of Nuclear Medicine

SSRCR Suggested State Regulations for

Control of Radiation

TENORM Technologically Enhanced

Naturally Occurring

Radioactive Material
7.3

Appendices

A. Directives and References

This subsection provides documents that are background materials.

B. Working Group Interactions and Communications

This subsection describes in depth the stakeholder outreach

activities of the Working Group. Comments and responses are

summarized.

C. Evaluation of Program Elements

This subsection gives in depth information about program elements

and suggested alternatives.

D. Relative Decision Matrix

This subsection explains the relative decision matrix technique.
7.4

A. Directives and References

* National Materials Program Working Group Charter

* SECY-99-250

* Section 274 of the Atomic Energy Act
7.5

APPENDIX A

National Materials Program Working Group Charter

NRC formed a working group to provide the Commission with options for maintaining an infrastructure of supporting rules, guidance and other program elements needed for the nationwide materials program considering the anticipated increase in the number of Agreement States. The working group is composed of representatives of state governments and NRC. The Working Group will produce a report for the Commission's consideration.

The Working GrouD Mission

The mission is to develop options for the Commission's consideration for creating a National Materials Program that will implement the following philosophy:

To create a truepartnership of NRC and states that will ensureprotection ofpublic health, safety, and the environment while:

* optimizing resources offederal, state, professional and industrial organizations; * accountingfor individual agency needs and abilities;

* promoting consensus on regulatory priorities;

* promoting consistent exchange of information; and

* harmonizing regulatory approaches while recognizing state andfederal needsforflexibility.

To accomplish the mission, the working group will consider the following issues: 1. the continuing trend for states to assume authority for the regulation of radioactive materials;

2. the potential impact of this trend on maintaining the infrastructure of the existing state and federal regulatory programs in the current fiscal environment and the increased fee burden on a decreasing number of NRC licensees to support generic activities;

3. the roles and legal responsibilities of NRC, Agreement States, Organization of Agreement States, Conference of Radiation Control Program Directors, Inc., and other organizations;

4. the need for statutory changes in federal and state programs for a National Materials Program;

5. the required elements and scope of activities in a materials regulatory program such as licensing, inspection, enforcement, training, event reporting, emergency response and program support activities including developing licensing and inspection guidance, developing program policy and guidance, developing standard review plans, providing laboratory support, and rulemaking activities;

6. the assessment process and performance indicators that could be used to measure the performance of a National Materials Program considering the current Integrated Materials Performance Evaluation Program process;

7. mechanisms for program coordination and program evolution;

8. the resource needs required for a National Materials Program and options for meeting those

resource needs at both state and federal levels; and

9. accommodation of federal and state strategic performance goals and outcomes under a National Materials Program.
7.6

APPENDIX A

National Materials Program Secy-99-250

SECY-99-250 October 14,1999

FOR: The Commissioners

FROM: William D. Travers IsA Executive Director for Operations

SUBJECT: NATIONAL MATERIALS PROGRAM:REQUEST APPROVAL OF THE FORMATION OF A

WORKING GROUP ON THE INCREASE IN THE NUMBER OF AGREEMENT STATES AND

IMPACT ON NRC'S MATERIALS PROGRAM

PURPOSE:

To inform the Commission of the staff's plan to form a working group to address the impacts of the increased

number of Agreement States and to provide advice to the Nuclear Regulatory Commission (NRC) on the

National Materials Program.

BACKGROUND:

Presently, NRC exercises regulatory responsibility over about 5,310 material licensees. The 31 Agreement States

regulate about 16,550 material licensees. Staff expects four additional States will become Agreement States by

Fiscal Year (FY) 2003 and estimates that the number of NRC licensees will drop to approximately 4,000. At that

time, the Agreement States will be regulating about 17,860 licenses. This shift in responsibility has significant

implications for both NRC's materials program and the Agreement States. The process that NRC will use in the

future to develop and maintain the infrastructure of regulations and supporting guidance applied by NRC and the

Agreement States in their respective licensing and inspection programs should reflect this shift.

DISCUSSION:

Agreement State licenses currently comprise approximately 75% of the national total. With the forecast of four

more States signing agreements by FY 2003, Agreement State licenses soon may comprise over 80% of the

national total. In acknowledgment of this reallocation of licenses, NRC is placing more emphasis on program

activities in support of the national infrastructure, particularly with emphasis on program activities such as

rulemaking and guidance development activities, information technology systems, technical support, event

follow-up, and Integrated Materials Performance Evaluation Program (IMPEP). These activities have a fee impact on an increasingly smaller number of NRC licenses.

Although NRC and Agreement State staff refer to a "National Materials Program," or use similar references (e.g.,

coherent nationwide effort), no clear definition has been established to define what is meant by a National

Materials Program (e.g., its structure, characteristics, makeup, functions and resources). Staff believes the

following six issues are key to defining and implementing future State and Federal roles under a National Materials

Program and need to be addressed:

1. Development of an overall program mission statement with defined "top level" goals and objectives.

2. Delineation of the respective roles and legal responsibilities of NRC and the Agreement States, including the

Organization of Agreement States (OAS) and the Conference of Radiation Control Program Directors, Inc.,

(CRCPD).

3. Delineation of the scope of activities to be covered by the program and the need for statutory changes at both

State and Federal levels.

4. Establishment of formal program coordination mechanisms.

5. Establishment of performance indicators and a program assessment process to both measure program

performance and to ensure program evolution.

6. Provision/Budgeting of resources at both State and Federal levels.
7.7

APPENDIX A

National Materials Program SECY-99-250 - cont'd

To address the future of a National Materials Program, staff will establish a working group in accordance with

Management Directive 5.3, "NRC and Agreement State Working Groups," to examine the impacts of the

increased number of Agreement States and develop options for Commission consideration. The working group

would examine potential frameworks through which the regulation of nuclear materials can be accomplished in the

future when the size of Agreement State programs will collectively be significantly larger than that of NRC. The

working group would need to address these six issues within the context of other related activities. For example,

the group's actions must track with the appropriate materials arena goals, measures, and strategies from the new

NRC Strategic Plan, once this new Plan is completed by NRC staff, reviewed by our stakeholders, and approved

by the Commission. Regarding item 5, in establishing performance indicators and a program assessment process,

the working group will need to be sensitive to the ramifications of its output on the indicators already in place in

the IMPEP program. These IMPEP indicators were developed with significant input from NRC and the

Agreement States, and have proven to be a highly-successful means by which we assess the technical adequacy,

and consistency of our regional materials programs, and those in Agreement States.

The working group will be comprised of NRC, Agreement State, and CRCPD staff as follows:

Office of State Programs (OSP) - one representative (.5 FTE)

Office of Nuclear Material Safety and Safeguards (NMSS) - one representative (.25 FTE)

Office of the General Council (OGC) - one representative (.25 FTE)

Regional Office - one representative (.25 FTE)

CRCPD - one-two representatives (.25-.5 FTE)

OAS - one-two representatives (.25-.5 FTE)

RESOURCES:

Staff believes agency resources of approximately 1.25 FTE, would be required to characterize and frame these

issues for Commission review. This effort can be accommodated within the existing budget.

COORDINATION:

The Office of the General Counsel has no legal objections. The Office of the Chief Financial Officer has reviewed

this Commission paper for resource implications and has no objections.

William D. Travers

Executive Director for Operations
7.8

APPENDIX A

Section 274 of the Atomic Energy Act

ATOMIC ENERGY ACT OF 1954

Sec. 274. Cooperation With States.

a. It is the purpose of this section-

(1) to recognize the interests of the States in the peaceful uses of atomic energy, and to clarify the respective responsibilities under this Act of the States and the Commission with respect to the regulation of byproduct, source, and special nuclear materials;

(2) to recognize the need, and establish programs for cooperation between the States and the

Commission with respect to control of radiation hazards associated with use of such materials;

(3) to promote an orderly regulatory pattern between the Commission and State governments with

respect to nuclear development and use and regulation of byproduct, source, and special nuclear

materials;

(4) to establish procedures and criteria for discontinuance of certain of the Commission's regulatory responsibilities with respect to byproduct, source, and special nuclear materials, and the assumption thereof by the States;

(5) to provide for coordination of the development of radiation standards for the guidance of Federal agencies and cooperation with the States; and

(6) to recognize that, as the States improve their capabilities to regulate effectively such materials, additional legislation may be desirable.

b. Except as provided in subsection c., the Commission is authorized to enter into agreements with the Governor of any State providing for discontinuance of the regulatory authority of the Commission under Chapters 6, 7, and 8, and Section 161 of this Act, with respect to any one or more of the following materials within the State-

(1) byproduct materials as defined in section 11e.(1);

(2) byproduct materials as defined in section Ile.(2);

(3) source materials;

(4) special nuclear materials in quantities not sufficient to form a critical mass.
7.9

APPENDIX A

Section 274 of the Atomic Energy Act - cont'd

During the duration of such an agreement it is recognized that the State shall have authority to regulate the

materials covered by the agreement for the protection of the public health and safety from radiation hazards.

c. No agreement entered into pursuant to subsection b. shall provide for discontinuance of any authority and

the Commission shall retain authority and responsibility with respect to regulation of-

(1) the construction and operation of any production or utilization facility or any uranium

enrichment facility;

(2) the export from or import into the United States of byproduct, source, or special nuclear

material, or of any production or utilization facility;

(3) the disposal into the ocean or sea of byproduct, source, or special nuclear waste materials as

defined in regulations or orders of the Commission;

(4) the disposal of such other byproduct, source, or special nuclear material as the Commission

determines by regulation or order should, because of the hazards or potential hazards thereof, not be

so disposed of without a license from the Commission. The Commission shall also retain authority

under any such agreement to make a determination that all applicable standards and requirements

have been met prior to termination of a license for byproduct material, as defined in section lle.(2).

Notwithstanding any agreement between the Commission and any State pursuant to subsection b., the

Commission is authorized by rule, regulation, or order to require that the manufacturer, processor, or

producer of any equipment, device, commodity, or other product containing source, byproduct, or special

nuclear material shall not transfer possession or control of such product except pursuant to a license issued

by the Commission.

d. The Commission shall enter into an agreement under subsection b. of this section with any State if-

(1) The Governor of that State certifies that the State 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 that the State desires to assume regulatory

responsibility for such materials; and

(2) the Commission finds that the State program is in accordance with the requirements of subsection

o. and in all other respects compatible with the Commission's program for regulation of such

materials, and that the State program is adequate to protect the public health and safety with respect

to the materials covered by the proposed agreement.

e. (1) Before any agreement under subsection b. is signed by the Commission, the terms of the proposed

agreement and of proposed exemptions pursuant to subsection f. shall be published once each week

for four consecutive weeks in the Federal Register; and such opportunity for comment by interested

persons on the proposed agreement and exemptions shall be allowed as the Commission determines

by regulation or order to be appropriate.
7.10

APPENDIX A

Section 274 of the Atomic Energy Act - cont'd

(2) Each proposed agreement shall include the proposed effective date of such proposed agreement or exemptions. The agreement and exemptions shall be published in the Federal Register within thirty days after signature by the Commission and the Governor.

f. The Commission is authorized and directed, by regulation or order, to grant such exemptions from the licensing requirements contained in chapters 6, 7, and 8, and from its regulations applicable to licensees as the Commission finds necessary or appropriate to carry out any agreement entered into pursuant to subsection b. of this section.

g. The Commission is authorized and directed to cooperate with the States in the formulation of standards for protection against hazards of radiation to assure that State and Commission programs for protection against hazards of radiation will be coordinated and compatible.

h. There is hereby established a Federal Radiation Council, consisting of the Secretary of Health, Education, and Welfare, the Chairman of the Atomic Energy Commission, the Secretary of Defense, the Secretary of Commerce, the Secretary of Labor, or their designees, and such other members as shall be appointed by the President. The Council shall consult qualified scientists and experts in radiation matters, including the President of the National Academy of Sciences, the Chairman of the National Committee on Radiation Protection and Measurement, and qualified experts in the field of biology and medicine and in the field of health physics. The Special Assistant to the President for Science and Technology, or his designee, is authorized to attend meetings, participate in the deliberations of, and to advise the Council. The Chairman of the Council shall be designated by the President, from time to time, from among the members of the Council. The Council shall advise the President with respect to radiation matters, directly or indirectly affecting health, including guidance for all Federal agencies in the formulation of radiation standards and in the establishment and execution of programs of cooperation with States. The Council shall also perform such other functions as the President may assign to it by Executive order.

i. The Commission in carrying out its licensing and regulatory responsibilities under this Act is authorized to enter into agreements with any State, or group of States, to perform inspections or other functions on a cooperative basis as the Commission deems appropriate. The Commission is also authorized to provide training, with or without charge, to employees of, and such other assistance to, any such State or political subdivision thereof or group of States as the Commission deems appropriate. Any such provision or assistance by the Commission shall take into account the additional expenses that may be incurred by a State as a consequence of the State's entering into an agreement with the Commission pursuant to subsection b.
7.11

APPENDIX A

Section 274 of the Atomic Energy Act - cont'd

j. (1) The Commission, upon its own initiative after reasonable notice and opportunity for hearing to

the State with which an agreement under subsection b. has become effective, or upon request of the

Governor of such State, may terminate or suspend all or part of its agreement with the State and

reassert the licensing and regulatory authority vested in it under this Act, if the Commission finds

that (1) such termination or suspension is required to protect the public health and safety, or (2) the

State has not complied with one or more of the requirements of this section. The Commission shall

periodically review such agreements and actions taken by the States under the agreements to insure

compliance with the provisions of this section.

(2) The Commission, upon its own motion or upon request of the Governor of any State, may, after

notifying the Governor, temporarily suspend all or part of its agreement with the State without

notice or hearing if, in the judgment of the Commission:

(A) an emergency situation exists with respect to any material covered by such an agreement

creating danger which requires immediate action to protect the health or safety of persons

either within or outside of the State, and

(B) the State has failed to take steps necessary to contain or eliminate the cause of the danger

within a reasonable time after the situation arose.

A temporary suspension under this paragraph shall remain in effect only for such time as the

emergency situation exists and shall authorize the Commission to exercise its authority only to the

extent necessary to contain or eliminate the danger.

k. Nothing in this section shall be construed to affect the authority of any State or local agency to regulate

activities for purposes other than protection against radiation hazards.

1. With respect to each application for Commission license authorizing an activity as to which the

Commission's authority is continued pursuant to subsection c., the Commission shall give prompt notice to

the State or States in which the activity will be conducted of the filing of the license application; and shall

afford reasonable opportunity for State representatives to offer evidence, interrogate witnesses, and advise

the Commission as to the application without requiring such representatives to take a position for or against

the granting of the application.

m. No agreement entered into under subsection b., and no exemption granted pursuant to subsection f., shall

affect the authority of the Commission under subsection 161b. or i. to issue rules, regulations, or orders to

protect the common defense and security, to protect restricted data or to guard against the loss or diversion

of special nuclear material. For purposes of subsection 161i., activities covered by exemptions granted

pursuant to subsection f. shall be deemed to constitute activities authorized pursuant to this Act; and special

nuclear material acquired by any person pursuant to such an exemption shall be deemed to have been

acquired pursuant to section 53.
7.12

APPENDIX A

Section 274 of the Atomic Energy Act - cont'd

n. As used in this section, the term "State" means any State, Territory, or possession of the United States, the Canal Zone, Puerto Rico, and the District of Columbia. As used in this section, the term "agreement" includes any amendment to any agreement.

o. In the licensing and regulation of byproduct material, as defined in section le. (2) of this Act, or of any activity which results in the production of byproduct material as so defined under an agreement entered into pursuant to subsection b., a State shall require-

(1) compliance with the requirements of subsection b. of section 83 (respecting ownership of byproduct material and land), and

(2) compliance with standards which shall be adopted by the State for the protection of the public health, safety, and the environment from hazards associated with such material which are equivalent, to the extent practicable, or more stringent than, standards adopted and enforced by the Commission for the same purpose, including requirements and standards promulgated by the Commission and the Administrator of the Environmental Protection Agency pursuant to sections 83, 84, and 275, and

(3) procedures which-

(A) in the case of licenses, provide procedures under State law which include-

(i) an opportunity, after public notice, for written comments and a public hearing, with a transcript,

(ii) an opportunity for cross examination, and

(iii) a written determination which is based upon findings included in such

determination and upon the evidence presented during the public comment period and which is subject to judicial review;

(B) in the case of rulemaking, provide an opportunity for public participation through written comments or a public hearing and provide for judicial review of the rule;

(C) require for each license which has a significant impact on the human environment a written analysis (which shall be available to the public before the commencement of any such proceedings) of the impact of such license, including any activities conducted pursuant thereto, on the environment, which analysis shall include-

(i) an assessment of the radiological and nonradiological impacts to the public health

of the activities to be conducted pursuant to such license;

(ii) an assessment of any impact on any waterway and groundwater resulting from

such activities;
7.13

APPENDIX A

Section 274 of the Atomic Energy Act - cont'd

(iii) consideration of alternatives, including alternative sites and engineering

methods, to the activities to be conducted pursuant to such license; and

(iv) consideration of the long-term impacts, including decommissioning,

decontamination, and reclamation impacts, associated with activities to be

conducted pursuant to such license, including the management of any byproduct

material, as defined by section 11e.(2); and

(D) prohibit any major construction activity with respect to such material prior to

complying with the provisions of subparagraph (C).

If any State under such agreement imposes upon any licensee any requirement for the payment of

funds to such State for the reclamation or long-term maintenance and monitoring of such material,

and if transfer to the United States of such material is required in accordance with section 83b. of

this Act, such agreement shall be amended by the Commission to provide that such State shall

transfer to the United States upon termination of the license issued to such licensee the total amount

collected by such State from such licensee for such purpose. If such payments are required, they must

be sufficient to ensure compliance with the standards established by the Commission pursuant to

section 161x. of this Act. No State shall be required under paragraph (3) to conduct proceedings

concerning any license or regulation which would duplicate proceedings conducted by the

Commission.

In adopting requirements pursuant to paragraph (2) of this subsection with respect to sites at which

ores are processed primarily for their source material content or which are used for the disposal of

byproduct material as defined in section 11e.(2), the State may adopt alternatives (including, where

appropriate, site-specific alternatives) to the requirements adopted and enforced by the Commission

for the same purpose if, after notice and opportunity for public hearing, the Commission determines

that such alternatives will achieve a level of stabilization and containment of the sites concerned, and

a level of protection for public health, safety, and the environment from radiological and

nonradiological hazards associated with such sites, which is equivalent to, to the extent practicable,

or more stringent than the level which would be achieved by standards and requirements adopted

and enforced by the Commission for the same purpose and any final standards promulgated by the

Administrator of the Environmental Protection Agency in accordance with section 275. Such

alternative State requirements may take into account local or regional conditions, including geology,

topography, hydrology and meteorology.
7.14

B. Working Group Interactions and Communications

* Communication Plan

* Meeting Schedule

* Meetings and Outreach Activities

* Questions and Comments from NRC Staff

* Responses to Stakeholder Questions NEHRC Meeting

* Input from Health Physics Society Focus Groups South Texas Chapter

Atlanta Chapter

New Jersey Chapter
7.15

APPENDIX B

Communication Plan

General Overview

The NRC and States are in the process of developing options for a National Materials

Program which will potentially offer opportunities for NRC, Agreement and non-Agreement

States to work together in a more collaborative manner to achieve efficiencies in implementing

our individual and joint responsibilities for regulating the use of radioactive materials and

radiation sources. A Working Group has been formed, at the direction of the NRC

Commission, to develop various options for implementing such a program. The Working

Group has identified a need to provide information to various stakeholders on development of

options that will be presented to the Commission and to seekfeedbackfrom its stakeholders

during product development and once a draft product is completed. This communication

plan provides an approach for meeting this need.

Objectives

1. Provide information to stakeholders in a timely manner, as the product is developed

2. Create positive stakeholder perception by seekingfeedbackfrom stakeholders as

products are developed and working in a collaborative manner with all stakeholders to

develop recommendations for the Commission

3. Engage misconceptions, correct inaccurate information, and reduce uncertainty

4. Actively engage stakeholders at all levels by soliciting feedback and maintaining

positive relationships

5. Identify issues involving a cultural transition of NRC, State and other stakeholders and

seekfeedback on how these issues can be addressed

6. Consider stakeholder comments in Working Group products

Stakeholders

* NRC Staff. HQ, Various Program Offices, Regions

* Agreement and non-Agreement State Staff

* Other Regulatory Agencies: EPA, OSHA, DOT, FDA, DOE, DOL, MSHA, DOI

* Licensees

* The Public

* Industry Representatives: Manufacturers, Consultants, Professional

Organizations (SNM, AMA, HPS, ASNT, SMA4, NMA, NEI)

* Standards Organizations: NIST, ASME, ASNT, ANSI, ICRP, NCRP, IAEA

* OMB

* Congress and State legislatures

Citizen and Environmental Groups
7.16

APPENDIX B

Communication Plan - cont'd

Communication Tools and Opportunities

* NRC Web Site and Written Communications: OSTP/NMPWG site, NMSS Newsletter,

Regional Web Sites or Newsletters, NR& C

* State Web Sites and Written Communications: Radrap, CRCPD Newsletter

* Federal Register

* Industry/Professional Written Communications: HPS Newsletter, ASNT Newsletter,

Journal of Nuclear Medicine, etc.

* Industry and Professional Meetings: HPS, ASNT, SNM, etc.

* State/NRC Interface: CRCPD meeting/poster session, OAS meetings and conference

calls, NERHC, NRC Counterpart Meetings

* Public Affairs Interface

* Pilot Projects: OAS tabletop exercise

* Senior Management Interface: EDO, Commissioner Technical Assistants, Senior

Management Meeting, IMfNS Director's Conference Calls, Commission Briefing

Message Development and Objectives

* Provide information on draft product, while in progress, to stakeholders and obtain

feedback

* Distribute messages directly to all levels of stakeholders and encourage individual

participation

* Consider stakeholder comments in developing Working Group products and provide

feedback to stakeholders regarding resolution or outcome

* Provide consistent messages by various communicators

* Provide a planned/structured communication approach corresponding to the various

stages of product development; the communication plan should accountfor the

challenges associated with the scope and complexity of the project at various stages in

development

* Account for the different perspectives of and needs for communication with external

stakeholders
7.17

APPENDIX B

Communication Plan - cont'd

Key Messages

Maintain safety by establishing a regulatory oversight framework that ensures that materials licensees continue to conduct activities involving use of radioactive materials and radiation sources in a safe manner. The States and NRC have done an excellent job in regulating materials users; however, due to the continued shift in regulatory oversight responsibilities and authorities from NRC to Agreement States, a more collaborative approach is needed. This approach should seek to balance use of resources between the States and NRC and distribute the resource burden more equitably between Agreement State and NRC licensees. Maintaining regulatory programs that are adequate to protect public health and safety is a priority in evaluating potential changes.

* Enhance public confidence by 1) increasing consistency and predictability in regulatory approach, while recognizing the needforflexibility among State and Federal regulatory programs, and 2) improving efficiency in implementing our regulatory oversight responsibilities.

* Improve the effectiveness and efficiency of regulatory programs nationwide by enhancing collaboration, through exchange of information and resources, promoting consensus among regulatory agencies and optimizing use of resources on a national level.

* Reduce unnecessary regulatory burden by promoting a consistent regulatory approach nationwide which will offer efficienciesfor licensees and greater predictabilityfor stakeholders.

NRC Stakeholders:

* Keeping NRC employees informed of current Working Group activities * Enhance stakeholder understanding of the draft product being developed and the process used by the Working Group

* Minimize concerns regarding potential changes in their roles as a regulator and potential transition in organization or activities

* Seek and respond to comments andfeedback of stakeholders
7.18

APPENDIX B

Communication Plan - cont'd

State Regulatory Stakeholders:

* Keeping State radiation control program staffs informed of current Working Group

activities

* Enhance stakeholder understanding of the draft product being developed and the

process used by the Working Group

* Minimize concerns regarding potential changes in their roles as a regulator and

potential transition in organization or activities

* Seek and respond to comments andfeedback of stakeholders

Other Regulatory Stakeholders (EPA, OSHA, DOT, FDA and others):

* Informing other potentially affected regulatory stakeholders of current Working Group

activities

* Enhance stakeholder understanding of the draft product and its potential impact on

any shared responsibilities or areas of interest

* Seekfeedback on potential impacts on other regulated activities or relationships

between regulatory agencies (State and Federal)

Industry and Licensee Stakeholders

* Keep regulated stakeholders informed of Working Group activities

* Enhance stakeholder understanding of potential impacts of the draft product on

stakeholder licensed activities

* Seek input on areas where regulatory burden can be decreased and eff ciency

enhanced

* Seekfeedback and respond to stakeholders

Public

* Inform public stakeholders of the issues and Working Group activities

* Seek feedback on whether proposed options meet strategic goals (e.g., maintain public

health and safety, increase efficiency and effectiveness, etc.)

* Seek feedback and respond to stakeholders
7.19

APPENDIX B

Communication Plan - cont'd

Citizen and Environmental Groups

* Inform public stakeholders of the issues and Working Group activities

* Seek feedback on whether proposed options meet strategic goals (e.g., maintain public health and safety, increase efficiency and effectiveness, etc.) * Seekfeedback and respond to stakeholders

Working with Regulatory Stakeholders

The Working Group recognizes that options developed for the National Materials Program and adopted by the Commission may change relationships between the Regions, XMSS, OSTP and the States. Since these changes will affect how administrative and technical staffs for NRC and States perform their work, it is important that the Working Group provide these

groups with information on the screening process and options and solicit their comments and input during the process of developing recommendations. Although dissemination of information will primarily be done using electronic and written communications, the Working Group considers it important to meet with stakeholders and make presentations atNRC and Agreement State offices and regional and national meetings to transmit key messages, provide updates on current activities and solicit inputfrom staff supervisors and management.

The Working Group plans to visit each of the NRC regional offices and headquarters during the development phase of the project and when the draft Commission Paper is prepared to make a presentation to NRC regulatory stakeholders to solicit their input. Outreach targeted at State regulatory stakeholders will include a poster presentation at the CRCPD annual meeting, a table top exercise at the annual OAS meeting, and a presentation and poster at the annual NERHC meeting. The Working Group has also scheduled its meetings atNRC and State offices to provide ready access for regulatory stakeholders.

Working with Non-Regulatory Stakeholders (licensees and public)

The Working Group recognizes that non-regulatory stakeholders' activities may also be impacted by options developedfor the National Materials Program and adopted by the Commission. NRC andAgreement State licensees may be affected by changes in regulatory programs at the State and Federal level; therefore, it is important that licensees be made

aware of the Working Group's efforts and provided opportunities to give their input during the development of options and recommendations. The Working Group is seeking opportunities to receive inputfrom licensees, particularly regarding issues relating to improving efficiencies
7.20

APPENDIX B

Communication Plan - cont'd

and identifying areas where changes in the materials regulatory program could lead to

reduction in regulatory burden while maintaining the current safety goals.

Consistent with the common goal of enhancing public confidence in our regulatory programs,

the Working Group also recognizes that it is desirable to seek inputfrom public stakeholders

regarding any proposed changes to the materials regulatory program. Thus, the Working

Group will examine methods by which we can actively engage public stakeholders by both

providing information and seeking their input.

Although dissemination of information will primarily be done using electronic and written

communications, the Working Group will seek opportunities to meet with non-regulatory

stakeholders during the development phase of the project. This will include opening Working

Group meetings to attendance by the public and presentations during industry and licensee

workshops and meetings.

Pilot Projects

The Working Group plans to conduct a pilot project in conjunction with the annual OAS

meeting. The pilot project will consist of an exercise involving representatives of the

Agreement States and NRC in which the representatives will attempt to reach a consensus

decision on regulatory priorities based on each agency's rulemaking and guidance

development agendas. This pilot will provide the Working Group the opportunity to 'field

test" a key component of a national materials program. It will also provide the regulatory

stakeholders the opportunity to compare individual agency agenda with their own and provide

the Working Group feedback on the viability of sharing regulatory priorities and reaching a

common agenda.

CRCPD G-34 Committee proposed a process for establishing a certification committee

comprised of OAS, CRCPD and NRC members. The committee would act as certifying entity

to review and approve certification regulations submitted by other agencies or groups.

Electronic Communications

The use of electronic communications is a key mechanism for providing stakeholders

information and soliciting input and feedback from regulatory and non-regulatory

stakeholders. The Working Group has established a web page, located with the OSTP web

page, which is accessible to both regulatory and non-regulatory stakeholders. The web page
7.21

APPENDIX B

Communication Plan - cont'd

includes the Group's charter, membership, screening criteria, evaluation ofprogram elements, meeting summaries and schedule of meetings, among other products. The web page is maintained with up-to-date information and provides contact information to solicitfeedback on the group's products. The Working Group plans to add links to other regulatory and non- regulatory stakeholder web pages.

Stakeholder Communication Issues

The Working Group has also utilized a joint State and NRC list server (Radrap) as aforum to communicate with regulatory stakeholders and plans to continue to use this resource to solicit inputfrom regulatory stakeholders.

Written Communications

In addition to the web page, the Working Group plans to prepare articles for CRCPD and HPS newsletters which will include an overview of events and policies leading up to the creation of the Working Group and the development of options and the screening processes used. The articles will also provide information on how stakeholders can provide input to this project.

Meetings

All working meetings of the Working Group are open to the public and are posted on NRC's web page. A list of planned meetings and presentations are attached.

Interface with Commission Staff

In order to keep the Commission staff informed, the Working Group will invite the Commissioners' technical assistants to Working Group meetings held in NRC headquarters. The Working Group will brief the technical assistants on the current status of the Working Group's products and solicit their input.

Commission Briefing

The Commission will be briefed on the recommendations of the Working Group at the conclusion of the project, which is projectedfor May 2001.
7.22

APPENDIX B

Meetings and Outreach Activities of the Working

Group

March 6-8, 2000, Rockville, MD (NRC headquarters) Working Group Meeting

April 10-12, 2000, Arlington, TX (NRC Region IV) Working Group Meeting

May 15-17, 2000, Tampa, FL CRCPD Annual Meeting

Poster Session

June 5-7, 2000, Denver, CO (State of Colorado Offices) Working Group Meeting

June 14, 2000, Rockville, MD Steering Committee Briefing

July 25, 2000, Lisle, IL (NRC Region l1l) Presentation to NRC Region IlIl Staff

July 27, 2000, Rockville, MD Presentation to NRC Standards

Developing Organization

August 7, 2000, King of Prussia, PA (NRC Region I) Presentation to NRC Region I Staff

August 21, 2000, Rockville, MD Steering Committee Briefing

August 22-24, 2000, Rockville, MD Working Group Meeting

August 24, 2000, Rockville, MD Technical Assistants Briefing

September 6, 2000, Atlanta, GA (NRC Region II) Presentation to NRC Region II Staff

September 11-13, 2000, Lisle, IL Working Group Meeting

October 2-5, 2000, Charleston, SC OAS Annual Meeting Presentation to States and Table Top Exercise

Working Group Meeting

November 2000, HPS Newsletter Articles on NMP and NMPWG seen by regulatory and non-regulatory stakeholders

November 2, 2000, Rockville, MD Presentation to NRC Headquarters Staff

November 11, 2000, Austin, TX South Texas Chapter Health Physics Society Presentation to Non-Regulatory Stakeholders

November 15, 2000, Mystic, CT Annual NERHC Meeting Presentation to States and Regional Federal Staff

November 2000, Arlington, TX Presentation to NRC Staff
7.23

APPENDIX B

Meetings and Outreach Activities of the Working

Group - cont'd

December 5-7, 2000, Rockville, MD Steering Committee Briefing

Working Group Meeting

December 2000/January 2001, NMSS Newsletter Articles on NMPWG

February 20-23, 2001, Arlington, TX Working Group Meeting

February 21-22, 2001, Arlington, TX Public Meeting (transcript available at OSTP website)

January 2001, Atlanta, GA Atlanta Chapter Health Physics Society Presentation to Non-Regulatory Stakeholders

March 20-22, 2001, Rockville, MD Steering Committee Briefing

Working Group Meeting

March 22, 2001, Princeton, NJ New Jersey Chapter Health Physics Society Presentation to Non-Regulatory Stakeholders

April 3-6, 2001, Atlanta, GA (State of Georgia Offices) Working Group Meeting

April 29-May 2, 2001, Anchorage, AK Annual CRCPD Meeting

Presentation to States
7.24

APPENDIX B

Questions and Comments from NRC Staff

The following questions were asked by NRC Staff during outreach presentations on the

July 

activities and status of the National Materials Program Working Group (NMPWG) from through November 2000. Since the NMPWG continued to develop a National Materials Program (NMP) as it interacts with the NRC staff, the questions and comments raised were invaluable to the NMPWG in refining the NMP and clearly communicating NMP the at later meetings with stakeholders. The questions are grouped into four categories: historical, process, structure, and implementation.

Historical

* Has 

CRCPD?

there ever been an example of a major rule making initiated by the States or the

* Have otherfederal entities or agencies pursued the NMP concept with the states?

Process

* Why are all State National Materials Program Working Group (NMPWG) members from Agreement States?

* 

Commission?

Who initiated the NMP effort? How will the NMPWGfindings be presented to the

* What will the NMPWG use as evaluation criteriafor options? * Has the OAS or CRCPD expressed support and needfor an NMP? * Who in NRCpromoted the SECYpaper to initiate the NMPWG? * Does senior NRC management support the NMPWG process? * 

* 

Is there some way to involve more non-Agreement States in the NMPWG process? Is 

recommendations?

there an expectation that the NMPWG propose options to the Commission and give

* 

what 

The WG should meet with large non-Agreement states and provide a presentation on

doing 

the 

with 

NMPWG 

NRC 

is doing and trying to accomplish (Le., same outreach the WG is staf]). * The NMPWG should return to the Regions when the draft paper is completed.

Structure

* 

Organization 

What is the Conference of Radiation Control Program Directors (CRCPD) and ofAgreement States (CAS)? * What are Centers of Excellence/Expertise? * How are State radiation programsfunded? * What is meant by an NMP?

* The NMPWG needs to consider plural statutes (Le., those statutes with overlapping interests) when looking at changing the Act. * 

Office 

Will the NMP be an advisory committee or will it bring forth the things that NRC's of Nuclear Materials Safety and Safeguards (NMSS) does now?
7.25

APPENDIX B

Questions and Comments from NRC Staff - cont'd

* Can you give us any insight into what the NMP will look like?

* Doesn 't the NRC write regulations because they are needed?

* The NMPWG should be aware that some states have no infrastructure to participate in

an NMP.

* Has the NMPWG considered outside sources such as the National Academy of Science

(NAS) report on medical regulation by the NRC?

* What is compatibility and how is it determined?

Implementation

* Have all Agreement States bought into the NMPWG process?

* If States don 'tparticipate in the National Materials Program (NMP), will they still get

the benefits?

* Why not use a "Work Control Center" to distribute NMP work?

* How will the NMP befunded?

* If Centers of Excellence/Expertise are used to share resources, how does one address

consistency if the compatibility requirements allow States to be more restrictive with

some NRC requirements?

* Has the NMPWG considered enforcement in the NMP, particularly the needfor consistent

application of enforcement across jurisdictions and sharing of information?

* How would the NMP handle a situation that occurred several years ago when some states

explored regulating Veterans Administration (VA) hospitals and the VA shot down the idea in

a hurry?

* Can the states tell the NRC that a regulation is needed?

* How would the NMP handle a recent situation where the NRC went to the States to get

consensus on writing a radiography certification exam in Spanish? Although there was

compromise reached that was not adequate, consensus did not work on this simple problem

The entire episode was embarrassing and complicated by some states having English only

laws.

* The NMPWG needs to consider how the NMP will affect the U.S. Territories (Puerto

Rico, Guam, etc.).

* The NMPWG needs to consider the impact of States entering Indian Tribal lands.

* Has the NMPWG considered specif c changes needed to the Act?

* How long will it take to change the Atomic Energy Act?

* If NRC activities are restructured, how will that apply to States and other federal

agencies?

* The NMP must track andfollow centers of excellence/expertise. These centers must be

identified rapidly and effectively response to changes in these centers.

* How will the NMP identify centers of excellence/expertise? Will the NMPWG come up

with the criteria?

* Does geography have to be a constraint to identifying centers of excellence/expertise?

Can there be multiple centers of excellence/expertise for the same element?
7.26

APPENDIX B

Responses to Stakeholder Questions at NERHC

Meeting

Responses to Questions Distributed to Participants Meeting November 15,2000

How 

What problems have you encountered with interactions with government agencies (State/Federal)? could it be fixed?

Lack of uniformity with standards, philosophy, approach to radiation regulatory matters in all Federal agencies. I submit there may be more variation here than between the individual states in many areas.

Interagency federal bickering. The fix, have one agency set limits

Communication 

Agreement 

between the NRC and States, i.e., notification of NRC inspection in an State only after the NRC conducts inspection (no chance for accompaniment) and 

their 

inconsistent site release standards between federal agencies - States are coming up with own.

Are 

Materials 

there any 

Program 

other programs (regulatory or other) that could be used as a model for the National (NMP)?

Have seen great things develop under the NRC/Agreement State program. The present IMPEP 

much 

situation is very good. I have noticed recently however that the states seem to have less respect or consideration from the NRC Commissioners. Maybe 

elected 

one 

official.

of the NRC Commissioners should be the CRCPD Chairperson or a CRCPD

How could consistency between regulatory programs be improved?

Start at the federal levels, more resources

You 

OAS. 

need 

The buy-in of the States. This may be increased with more tie-ins to the CRCPD or

the breadth 

reason I emphasize the CRCPD is because of the suggested state regulations and of the working groups.

Have only one set of regulations - this set of regulations should be agreed upon by all parties involved.

How do you feel about NRC concurring with States on regulatory priorities?

Uncomfortable if the NRC is the controlling agency with the States as second class partners. 

Nations? 

Will we develop a relationship similar to Federal government and Indian States provide funding with major NRC control?

Constitutional issues here.

I believe that some States do have better ideas when it comes to regulation and enforcement. I think that IMPEP can adequately identify these areas.

This is very important, especially with nuclear power plant decommissioning.
7.27

APPENDIX B

Responses to Stakeholder Questions at NERHC

Meeting - cont'd

Does NRC need a "lead" function?

Too broad an interpretation for an intelligent response

Certainly NRC has a national interest and congressional requirements. There should be a

lead function but the states need more input. In a democratic society, maybe the states

need as much pull in materials issues as we also issue machine licenses and material

licenses.

Yes

Are there additional responsibilities that States should assume?

Not known

I believe that states already assume all the required responsibilities. We know, however,

that some of the CRCPD work done on say, SSRCR Part D, that is not as important as the

NRC's Part 20 work being done and thus gets put on the back burner. Maybe we need to

integrate the process by elevating the CRCPD process and get better buy-in to the NRC

process.

What problems do regulatory agencies have working with each other?

Turf battles, perverse human nature

Lack of definitive direction from above. The agency heads act in a nearly autonomous

manner. We understand that the NRC and EPA need to work together on limits for

example. The fact that they haven't and that it will only be solved by congressional action

eliminates science from the process and is directly the responsibility of the agency heads - a

national disservice.

How can information sharing among agencies be improved?

Continue with the quasi-neutral ground the CRCPD provides.

Regular meetings together at a range of different levels.

E-mail and web site - RadRap is a great tool now.

How would you identify a Center of Expertise?

I do not see this as a major issue. Expertise is usually apparent. Perhaps the issue may be

to accept the apparent.

Rough identification could be based on experience and time. The Texas industrial

radiography test is an example. They have the most people with the longest experience.

Looking at how much work they have done and how long on a particular issue -, i.e., PET

licensing and inspection.
-- .- - 

7.28

APPENDIX B

Responses to Stakeholder Questions at NERHC

Meeting - cont'd

What are the alternatives to the current system of compatibility designation?

Abolish 

Control 

the concept of "Agreement States" as now seen, as having served its purpose. over weapons, source material and such could be returned by the Federal government.

The compatibility designation I think can work very well. The application of the designation 

problem 

and the assignment of the designation are the areas of disagreement. The is the subjectivity in the process.

Do you know of any statutes that would impact the Alliance?

I 

regarding 

am sure there are many. Start with the point that an individual state is the final authority the health, safety, and welfare of its citizen.

I am unclear on the Alliance and don't feel I can answer this question yet.

Should the Alliance be a regulatory function? Or should the role be extended to "outreach" (i.e., funding a study, etc.)?

At 

crammed present, 

with 

with the current climate, developing a regulatory operation will see their results fish hooks.

included 

If the state were to specifically be included in the process then I expect it would need to be

the Commission. 

in the NRC regulations and statutes so as not to be at the whim of the OED and

available 

But the Alliance shouldn't need to have a regulatory part - Just tie all the staff together.

If 

that 

we 

you 

can't 

would 

implement 

want?

the complete Alliance concept as envisioned, what are the minimum changes

Abolish 

Control 

the concept of "Agreement States" as now seen, as having served its purpose. over weapons, source material as such could be returned by the Federal government.

CRCPD on the NRC Commission.

Regulatory

What role should Non-Agreement States have in the Alliance?

A key question: We see little in this effort that serves non-Agreement States.

I 

office 

believe that no one should be specifically excluded. I think that they should not hold or official positions, but they should not be left out. They can still have good ideas.
7.29

APPENDIX B

Responses to Stakeholder Questions at NERHC

Meeting - cont'd

What role should industry/professional groups have in the Alliance?

Same as any other regulatory process. The regulated community, out of necessity, must be

fully involved. U.S. philosophy, in part, is consent of the governed to be governed.

As the Alliance sees fit. We may need professional help!

Their voice should be heard and implement changes they recommend.

How can the Working Group best exchange information with State staffs?

Through CRCPD.

RadRap works well in our State - additional information can be transmitted through

CRCPD e-mail.

Additional comments and suggestions

Just seems on the surface to further the agreement process with incentives to become an

Agreement State. Further, assumes radionuclides are the radiation control issue. I submit

that machines are an important component, probably larger. Where are they? Radon?

This appears to be money driven in part with the advent to non-Agreement States. Perhaps

the "Agreement State" concept approaches moribundity.
7.30

APPENDIX B

Input from Health Physics Society Focus Groups

South Texas Chapter of the Health Physics Society November 11, 2000

What types of issues/problems have you had interacting with government agencies (state or federal)?

A key element that needs to be considered with this effort is a continual reassessment of existing rules, answering the question "do they add any value to the public health?" Ex. Common violation in Texas has to do with package receipt and survey of packages, yet the fact is that packages don't leak, especially single use packages. Maybe the levels could be change in rule. Consider not adding additional layers of bureaucracy, but look at taking out layers that aren't adding to public health.

This Alliance should be considering compliance associated with license conditions imposed in lieu of rulemaking. This is considered unconstitutional by circumventing rulemaking process so the violations don't hold water. Consider a "parking ticket" for that instead of a notice of violation (NOV) process. Licensees are judged by NOVs received because there

are no dead bodies in this industry.

We respond to proposed rules based on workload. Using consensus standards has merit. For instance, the Health Physics Society (HPS) guidance on decommissioning compared to MARSSIM, which is gross and unusable...uranium orders of magnitude more restrictive than MARSSIM. Rely more on industry than on internal government promulgation (rulemaking/guidance).

Compatibility rules come with assumption that rule is going to improve public health and I would argue that point. Is it truly improving public health? Look at any regulatory action to see if really necessary first, regardless of what type of structure implements it.

What has changed with the increased volumes of rules, with exception of radiographers, that has actually done something to improve radiation safety? I would argue that the vast majority of rules have done nothing to directly to improve public health. Go towards performance-based rules, i.e., do you have a program to ensure such and such and are you following it, rather than writing detailed rules. Define the desired outcome rather than the how of getting there and spend time inspecting to ensure licensees are following their safety programs.

Approach should be performance-based using consensus standards...don't need to reinvent wheels. As long as the outcome is accomplished, fine.
7.31

APPENDIX B

Input from Health Physics Society Focus Groups -

cont'd

Should a National Materials Program include all types of radiations?

Yes... a licensee finds itself trying to develop policies for their facility and explaining them

to several different agencies. It's also hard to explain to users why three different sets of

rules apply to radioactive materials. For instance, NESHAPS were written with power

plants in mind and those assumptions don't always fit hospitals, academic institutions. It is

impossible to manage rules like that.

A VA hospital is an NRC licensee in Texas with x-ray machines and other than

byproduct...the NRC jurisdiction very incomplete...if we have problem with something

other than byproduct, they throw their hands up and walk away because they don't have

jurisdiction. What role has the NRC agreed to play in this (Alliance)? Since AEA limits

their role, if they decide not to participate, can they just walk away and do what they do

now?

The NRC should get out of the medical side altogether because their oversight's not

complete.

I worked at a research reactor and it was NRC inside reactor and TX outside. This creates

a lot of unnecessary paperwork which would certainly be eased with one set of regulators.

What do you see as your role in the Alliance (as a professional society and as a licensee)?

How much do professional society's have a role in this? Like BPS, what is their input and

what has their involvement been so far?

Does one entity need to have a lead function in the Alliance?

In TX, we went from BRC handling all waste issues to having it split out into several state

agencies and then coming back together, but its still not under one roof. How many other

states are in the same boat? Do you have everybody at the table to address these kinds of

issues across all RAM issues (like Texas Railroad Commission and Texas Natural

Resources Conservation Commission) ...rather than forming a fiefdom system where

someone can say, wait a minute I'm not playing that game because you didn't ask my

opinion, so I'm not letting the rad waste folks into the new world order.

I think there should be one lead agency/group and it should be responsible for setting goals

and holding the other agencies/groups accountable. This would help lead to consistent

regulation and hopefully interpretation. Should it be NRC? I don't think it would have to

be. CRCPD or OAS would be possible...or maybe all three together. I believe this would

keep everyone focused. I have some concerns that it will be difficult to get everyone (NRC,

Agreement states, EPA, waste agencies, etc.) together and work as a consensus group...too

many conflicting agendas and it might be difficult to develop a usable product for licensees.
7.32

APPENDIX B

Input from Health Physics Society Focus Groups - cont'd

How is a National Materials Program going to be evaluated/assessed?

The challenge you face in getting this group together is how a bunch of regulators are going to 

what 

identify what a good program is. Each has its own biases towards being regulators and a good program is. I think it would be nice to have an objective measure of that. The only indication that regulators have is that our rules are a little thicker...how many violations 

objective measure 

we issue...but evaluation is all within regulatory community. You have to get an outside of that....something outside of IMPEP. Maybe dosimetry data?...doses per workers in Texas vs. others. Otherwise, an evaluation would be like a bunch 

wants.

of car dealers assessing what's a good car without knowing what the customer

How are you going to know if this works? How are you going to know if the Alliance is a success or failure? What will it be measured against?

Are there other organizations, etc. that could be evaluated as model for a National Materials Program?

I can't think of another health-related entity that gets outside objective evaluation to be able to quantify it to management and other outside stakeholders, but this is an opportunity to take a professional leadership role and say we're going about things that are prudent. Its pretty tough to compare the radiation gig to tangibles in other programs such as vaccinations, heart disease. I don't think regulatory agencies across the country fully appreciate the pressures practicing professionals are under because we can't produce a 

management 

body count...all that can be produced are violations, license fees, etc. So upper tends to view it as a paper tiger. Think about objective measures.

ISO 1400 standards might be considered as a model because they are performance-based, not prescriptive. You read two pages before you get to the first "thou shall" and only on last page was the word "record."

Try looking at FFA. They regulate from the manufacturer to operation, but I'm not sure if they're as performance-based as needed.

Make every state an agreement state and leave NRC with reactors.

What are the positive things/negative things you see with the Alliance?

We tend to respond to proposed rules based on our workload. Using consensus standards is a good idea. For instance, the HPS guidance on decommissioning MARSSIM is much better than which is gross and unusable. You should rely more on industry standards than on internal government workings (government development of rulemaking/guidance).

Approach should be performance-based using consensus standards. You don't need to reinvent wheels. As long as the desired outcome is accomplished, fine.
7.33

APPENDIX B

Input from Health Physics Society Focus Groups -

cont'd

I would hate to see us lose, as a consequence of "nationalizing," some of the latitudes that

states have that allow us to operate in a more reasonable fashion. For instance, Texas' 300-

day half-life rule is risk-based, safe, and provides cost savings. If a national structure can

allow that latitude for positive and pragmatic rules! guidance, that's a good thing.

If this group could come up with consistent set of rules that apply to all radiation and can

do it as briefly as possible that would give us the flexibility to develop our own programs.

It would be a tremendous help and allow use of consensus standards. You could shorten

the rules by consolidating regulation of different uses into one set of rules, which would

allow one inspector from one agency to inspect all radiation use at a facility. This not only

saves time, but also gives us better feeling. However, if consensus means putting everyone's

opinion down, you will end up with documents that are thicker than what we have now.

Beware of building consensus by adopting everyone's opinions.

Is public safety any better because we have to jump through all the hoops now required

under expanded rules for license applications, operation, etc.? Our program is basically

the same thing. The rules are so prescriptive that they have removed the flexibility of the

RSO at a facility to come up with a program to achieve an outcome. The only way to get

consensus is to have more performance-based rules rather than very detailed rules.

I am often frustrated by differences in knowledge of regulators on certain topics. No one

regulator can be knowledgeable on every single topic. If I have ten radiation "topics" in

my facility, I'm very knowledgeable about those and I've hit regulator that's not...I get

frustrated. By using centers of expertise, our jobs would be easier because we would be

communicating on same plane and we wouldn't have to explain or teach along the way.

Using centers of excellence might make the process easier. It would be unreasonable to

believe that any one licensee could be expert in all health physics areas, so its also

unreasonable to believe that regulators should be expert in all fields.

Would the Alliance have any implications for getting individual states to get their waste

disposal acts together?

Waste is a system that's broken. NRC separated the issue of power plant waste vs.

everyone else's waste so the power plants have more of a solution, but we in the states can't

separate the two. NRC is doing things for power plants...entombment, rubblization...but

these give no relief to waste problems other entities face. We need to bring those back

together.

In the Alliance, we could have more of opportunity to input (just like we're doing here).

What we would like to see in rulemaking is to get consensus from licensees and more

consistency in rules...a uniform set of rules.

What's working with the system now? Dose limits/standards. The rules should just set out

standards and don't prescribe how to meet those. Be consistent with standards and use

compliance with those standards as an objective measure.
7.34

APPENDIX B

Input from Health Physics Society Focus Groups - cont'd

Who 

stakeholders?

are the stakeholders and what kind of input has the working group received from

Other stakeholders? Possibly IAEA...consider 

structure international agencies in terms of the and allowing input from those global entities.

Who 

has general 

is the public..who are you going to approach? The Texas Radiation Advisory Board public members...you could invite input from folks like that.

They 

There 

have 

are a lot of people that are industrial hygienists that are assigned the role of RSO.

particularly 

an interest, but don't tend to get involved in groups like HPS because they don't associate themselves as health physicists. Consider other safety professionals that may be in the RSO role. Use list of RSO's that you (Texas BRC) have.

Has any of the work or input been put on the web site to solicit information/input?

Put a link to the NMP web site at BRC web site and at the STCHPS web site.
7.35

APPENDIX B

Input from Health Physics Society Focus Groups -

cont'd

Atlanta Chapter of the Health Physics Society

January 2001

What types of issues/problems have you had interacting with government agencies (state or

federal)?

The biggest obstacle I can see is where different agencies (federal'state/local) have

conflicting regulations. Normally, the most restrictive is applied, but it would be nice to

have one set of rules to follow.

One set of rules & regulations for all states to follow, updated and put into action all at the

same time. I think NRC should do this.

Occasional problem of getting a definite answer within a week's time. Often a problem

getting copies of government publications that are cited by Agencies, but are no longer in

print or on the Internet.

Having worked on both sides, I can appreciate the blinders that can develop in one

particular position (job). Effort needs to be constantly placed on looking at the other guy's

position/purpose. A balance needs to be struck between the 'law' and true safety and

effectiveness, not just meeting the letter of the law. I have, in the past, had difficulty

getting access to not only the regulations, but supporting guides and policies.

Staff may not be empowered to work with staff of other groups, leaving intergroup

communications to top management rather than to intergroup teams who could be more

productive.

Should a National Materials Program include all types of radiations?

A National Materials Program should include all types of radiation, including natural. All

radiation should be treated the same in the regulations, regardless of its origin.

No (maybe microwave & laser) really not sure where other radiations should be.

No. I have a concern of everything being micro-managed, over-regulated out of all

proportion to actual risk levels and harm, as the NRC has done with nuclear medicine. The

burdens of paperwork (etc.) in cost, time and manpower have always been grossly under

estimated by the government.

I tend to be slow to warm up to change and will have to be convinced that the benefit of

including all radiations will result in either more efficient programs or safety and less

needless 'paperwork'.

Yes. Medical x-ray and radioactive material should be included under same regulatory

umbrella for consistent national protection of the population. A child would not know less

harm if their radiation dose was delivered by an unnecessary computerized tomography

operation or an unnecessary x-ray than an inadequately shielded radioactive source.
7.36

APPENDIX B

Input from Health Physics Society Focus Groups - cont'd

What do you see as your role in the Alliance (as a professional society and as a licensee)?

To show government how radioactivity is used in the 'real world'; how it should be realistically managed to achieve the user's purposes without undue risk to the public. The government should be made aware of the results of studies showing radioactivity's effects

on the human body (much less than ever estimated). We should keep government updated on results/benefits achieved from our work with radioactivity.

As a consultant, I will need to try to keep the lines of communication open both ways - to the regulators and to the clients.

Providing advice, guidance, and volunteer time to support radiation safety activities

Does one entity need to have a lead function in the Alliance?

There should be a lead entity in order to resolve potential disputes. The national body (NRC) is the natural choice to lead such an Alliance.

Yes (NRC)

There are both advantages to having one lead but there are also disadvantages. I think that the radiation field is so diverse that it will be a major adjustment to put all in one basket. The corporate history at most institutions will fight the change to a one-agency program. Just look a how long it is taking to change over to metric from the OLD ENGLISH.

Yes. Without a lead activity, the program will lack focus. The lead activity should receive Congressional funding for this effort. Perhaps Congress should provide incentives for all states to come under the same regulatory net.

How is a National Materials Program going to be evaluated/assessed?

By the NRC (we still need a strong central group)

The NMP will have to be evaluated in a manner to allow three things to still work: (1) Separation of State and Federal; (2) Programs and policies that are based on function not just resources and simple plans to reorganize; (3) Clear and reasonable objectives need to be established and delineated before sweeping changes are put into place.

Under revised NRC regulations under which the Agreement States would function. This would likely require a re-enactment of the Atomic Energy Act under another name (Radiation Oversight Act) to pull in NORM and TENORM.
7.37

APPENDIX B

Input from Health Physics Society Focus Groups -

cont'd

Are there other organizations, etc. that could be evaluated as model for a National Materials

Program?

No (need only one, NRC)

I have limited knowledge of materials programs but, the MQSA/FDA fee for servicecontracted-to-states has potential. Major harmonization with Fed law and the ability of

states to modify their laws need to be included in the process.

As a concept model, CDC has centers for specific tasks, such as National Center for

Environmental Health, National Center for Infectious Diseases, etc. Centers for licensee

support could be established (perhaps by a bid process) in various states, such as a National

Center for Radiography located in Texas or Louisiana where radiography companies are

quite active. Others could include the Center for Medical Therapy, Center for X-Rays,

Center for Calibration, Center for Licensing, Center for Operational Oversight, etc. Those

centers could specialize in supporting one type or group of licensees, and inter-center

functional interfaces would be beneficial. - Amend the Atomic Energy Act to give the

licensee overseer authorization to control, manage, license, and audit x-rays, acceleratorproduced RAM, NORM, TENORM, etc. - Then change the title of Nuclear Regulatory

Commission to break the past mold and lead into a new future. An example is the

Radiation Safety Agency, with subgroups called the Centers for Radiation Safety. The

emphasis is that radiation can and will be used safely and consistently. - Lean toward using

general funds rather than licensee fees, or a combination to ease pressure from both sides.

What are the positive things/negative things you see with the Alliance?

The Alliance's greatest benefit is probably as an information-sharing group. States and

NRC should share their analyses and data so that others do not have to reexamine the same

problems or issues.

Maybe hard to get agreement if too many folks get involved. Some group needs to step in

and say: 'this is the way it is going to be' & all licensees, states, etc., follow the same book of

rules at the same time.

See all the above

Positive: More consistent and manageable set of regulations, more uniform protection of all

facets of the public (child health, under represented populations, sensitive populations),

reduction or elimination of duplicate effort by multiple regulators with different focuses

(reduced size of government), lower cost of regulation. -Negative: Overcoming the rice

bowl effect may be emotional, change may initially be painful.
7.38

APPENDIX B

Input from Health Physics Society Focus Groups - cont'd

New Jersey Chapter Health Physics Society

March 22, 2001

What types of issues/problems have you had interacting with government agencies (state or

federal)?

Different sets of regulations and standards

NRC - very professional; New York State - somewhat political, not professional and

misinterprets its own regulations

None (2 times)

Poorly worded regulations; difficult to follow, need to get interpretation from regulatory

agency

Inconsistent requirements (e.g., decontamination and decommissioning total effective dose

equivalent of 25 mrem/yr for NRC, 15 mrem/yr for New Jersey). Redundant regulations

or obsolete regulations that are not updated

Both - technical knowledge isn't as well as I would like

None on routine basis. Lack of consistency from inspector to inspector when they come on

site.

Can be inflexible, especially with new or unique situations. Several times I've been told the

regulation was not written for that situation, but try to comply anyway.

Should a National Materials Program include all types of radiations?

Yes (3 times)

Yes, because New Jersey is implementing draconian dose limits for NORM in soil (e.g. 3

mrem/yr)

Yes, otherwise, there will always be regulatory agencies against the Alliance (e.g., DOE)

Yes. One consistent voice is the best way to go. Multiple agencies and federal and state

involvement is too complicated (just look at asbestos regulations)

No. Neutron sources should be regulated by a single agency. Much more dangerous then

the three other types

Should include NORM, accelerator and reactor. Not x-ray, microwave, NMR

Yes, it would make it easier for a safety department

All ionizing radiation sources that are not natural
7.39

APPENDIX B

Input from Health Physics Society Focus Groups - cont'd

How is a National Materials Program going to be evaluated/assessed?

How realistic and practical the ultimate program is; Will it have money; How it encourages

or discourages commerce

Take evaluations from each license holder

Will it improve on the current way of doing business

Performance indicators

Did anything bad happen? Is everything accounted for?

Force States into uniform response to licensees. Between states, NY State Department of

Labor does not issue license or regulations to licensees, Massachusetts requires HP

consultants to register. Use federal money to research and publish new regulations

consensus

Unfortunately, money will be a primary factor

Performance based - are there problems out there and are they being addressed properly?

How could consistency between regulatory program be improved.

It would be nice to have overall consistency

A council that involves each state regulation makers might be able to help in consistency

Keep basics uniform across the country. Hard to be consistent with everything in each

state. Agreement on this would be hard to achieve

Have one set of standards for all as viable and feasible. Avoid multiple inspections by different regulatory agencies

If I had a good answer to this question, I'd be rich (or at least a decent politician)

Ensure good science goes into regulations. Force a state to perform a justification of

regulations on doses that are more stringent then NRC regulations - must include risk

based assessment.

Use a consensus committee

Base concentration limits on dose - period! One agency could control all exposure to

radiation doses.

Design a single agency for radiation; state or federal or clear demarcations, i.e., all air

emissions are EPA, occupational exposure NRC, all medical programs by the states

Are there other organizations, etc. that could be evaluated as model for a National Materials

Program?

State EPA agencies

Perhaps organizations outside the United States

Development of MARSSIM manual
7.40

APPENDIX B

Input from Health Physics Society Focus Groups - cont'd

What do you see as your role in the Alliance (as a professional society and as licensee)?

Provide 

To give feedback as far as how well they are doing and what changes are needed comments/insights 

Not 

to be used in formation of policies and regulations

input

as a licensee, but a society should have a voice in rule making through commentary and

The 

State 

Health 

and NRC 

Physics 

and 

Society 

corporations/business. 

should be separate equal member in the alliance. Separate from

through the political Licensees (as businesses) already have a voice entities that would be in the alliance Open minded to listen to issues from another member's viewpoint As 

Victim, 

a licensee, 

vocal 

one 

participant

set of regulations, especially when one has facilities in a number of states

Does one entity need to have a lead function in the Alliance?

Yes (2 times)

Depends on what and extent of lead function means The Alliance should have a Commission representing its constituency Yes, federal NRC to ensure overall consistency and a steady driver

Yes, 

Yes, it 

probably 

is all well to have it as a committee decision, but there needs to be one leader at the federal level

What are the positive things/negative things you see with the Alliance?

Greater freedom for each State is a positive, difficulty with compatibility Will be is a negative hard to get consensus

Positive: 

adequate 

standardization of statutes, optimal use of resources; Negative: possible lack of representation for Non-Agreement States Positive: 

Negative: stop redundancy, move NRC from parent to adult role in dealing with licensees.

more on 

a consensus decision is hard to come by (no quick decision), will probably cost

Some 

administrative costs, loss of good science to balance view states will resist any change I need to hear more about it
7.41

C. Evaluation of Program Elements

* Summary of Program Element Evaluations

* Materials Licensing Guidance

* Materials Inspection Guidance

* Materials Licensing and Inspection

* Performing Materials Inspection

* Performing Materials Licensing

* Reciprocity

* Technical Guidance Documents

* Training, Qualification and Experience Standards

* Regulatory Program Reviews

* Regulatory Program for General Licensees - Regulating Agency * Regulatory Program for General Licensees - Implementation * Certification Program

* Rulemaking

* Information Infrastructure
7.42

APPENDIX C

Summary of Program Element Evaluations

The Working Group identified and evaluated potential program elements required to

support a "National Materials Program" as part of its initial evaluation process. Candidates for the group of program elements were selected by the Working Group

based on current program elements common to NRC and Agreement State regulatory

programs. The group used IMPEP and CRCPD guidance as a basis for identifying

program elements. The following program elements were evaluated:

Materials licensing, with particularfocus on guidance governing the licensing

process;

* Materials inspection, with particular focus on guidance governing the inspection

process;

* Alternative options for States to perform licensing and inspection functions for all

facilities within their respective State;

* Implementation of the materials inspection program;

* Implementation of the materials licensing program;

Reciprocity, or the States' and NRC's process for allowing a materials licensee to

conduct licensed operations in areas under another regulatory agency's jurisdiction; * Technical Guidance, with specific focus on procedural guidance for specific

activities that may be used by licensees in support of their programs or license

application submittals;

* Training, Qualification and Experience Standards for regulatory personnel;

Regulatory program reviews;

* Regulatory program for general licensees;

Certification Programs;

Rulemaking;

* Information Infrastructure;

* Incident/Event Response and Coordination;

* Generic Event Assessment; and

* Research (anticipatory and confirmatory)

It should be noted that the program elements were intended to be sufficiently broad to

capture a full spectrum of activities. For instance, material licensing is intended to include

licensing source, byproduct, and special nuclear material. Thus, these elements include

consideration of specific byproduct materials licensees, uranium recovery facilities, and

sealed source and device reviews, among other types of licensing activities.
7.43

APPENDIX C

Summary of Program Element Evaluations - cont'd

Summary of Recommended Alternatives for Program Elements

Materials Licensing Guidance

NRC/Agreement States (AS) should jointly develop an agenda and priorities for developing

licensing guidance. NRCIAS either use working groups to develop guidance or direct

other organizations/entities to develop guidance when appropriate.

Materials Inspection Guidance

NRC/AS should jointly establish priorities and develop inspection guidance. Joint working

groups should be used to develop guidance. Alternatively, NRCIAS may also accept

consensus standards (following review and revision, if needed) or contract with other

organizations to develop guidance when not available and needed.

Materials Licensing and Inspection - Alternative for States to Perform Licensing and

Inspection for All Facilities within Their Respective State

The Working Group requires input from OGC regarding legal issues that may be

associated with AS either being granted statutory authority or delegated authority to

perform licensing, inspection and enforcement for Federal and other facilities normally

regulated by NRC.

Performing Materials Inspections

Maintain the current inspection program, but supplement the existing program with other

options. NRC would perform inspections for all facilities authorized to possess/use AEA

materials in non-AS and at federal facilities in AS. NRC would also perform inspections of

general licensees and exempt distribution licensees located in non-AS and AS. AS would

inspect facilities located in their respective states. Supplemental options would include: 1)

allowing other entities to contract with NRC/AS to perform inspections and report results

to the appropriate regulatory agency; 2) allowing licensees to perform self-audits which

may be accepted in lieu of inspection by NRCIAS or reduce inspection effort by NRC/AS; 3)

accept audits performed by other organizations and use these as a supplement to NRC/AS

inspections to reduce inspection effort by NRC/AS; and 4) use "Centers of Excellence" to

perform inspections of specific technical areas. Acceptance of licensee audits or audits

performed by independent organizations to modify NRC1AS inspection effort would be

determined by the appropriate regulatory agency in a selective manner. "Centers of

Excellence" could be either AS or NRC organizations and would be jointly recognized by

AS/NRC.
7.44

APPENDIX C

Summary of Program Element Evaluations - cont'd

Performing Materials Licensing

Maintain the current program and enhance both NRC and AS reviews through use of

contracted entities or "Centers of Excellence" to perform some license reviews or portions

of reviews for specific technical areas.

Reciprocity

The Working Group solicited comments from State stakeholders on this issue since NRC

is the only regulatory agency that enters another agency's domain to conduct inspections

of licensees working under reciprocity. (Note: AS cannot enter another State to conduct

inspections of AS or NRC licensees working within their State.) Based on comments

received, the Working Group determined that a recommendation for change in this area

was not warranted at this time. The Working Group's conclusion would not preclude

examination of this process under a separate initiative.

Technical Guidance Documents

Some organization would maintain a clearinghouse of technical documents evaluated and

approved by the National Materials Program for use. Consensus on priorities, needs and

recommendations for organizations to develop guidance should be jointly established by

NRC/AS.

Training, Qualifications & Experience Standards for Regulatory Personnel

Maintain the current program and enhance with: 1) use of a clearinghouse of training

ideas, resources and opportunities designed for or employed by NRCIAS; 2) allowing

licensees to provide training, on a voluntary basis, for specific technical issues or

consider contracting with licensees to train staff in specific technical areas; and 3)

encourage a regulatory agency exchange program to develop staff in specific technical

areas.

Regulatory Program Reviews

Utilize team (NRC/AS) effort in conducting program reviews using IMPEP guidance, but

fully implement use of "Centers of Excellence" to assist with team composition.

Regulatory Authority for General Licensees - Regulatory Agency

This needs to be examined concurrently with the following element. The Working Group

recommends that this be discussed with the Steering Committee for consideration of

whether a second working group should evaluate the General License program.
7.45

APPENDIX C

Summary of Program Element Evaluations - cont'd

Regulatory Program for General Licensees - Implementation

Some of the options were rated by the Working Group; however, given the discrepancies in how these items are regulated and the number of questions regarding the basis for

authorizing distribution and use of generally licensed items, the Working Group elected to

discuss this element with the Steering Committee. The Working Group is seeking advice

on whether this issue should be reviewed by a separate group.

Certification Programs

Use CRCPD's G-34 Committee Certifying Entity process as an example (with minor

modification) of how an element of a National Materials Program could work. Evaluate

successes and problems identified by G-34 during initial implementation of the process, and document input received from G-34 with the working group's report.

Rulemaking

NRC/AS jointly develop a rulemaking agenda and establish a cooperative group to draft

rules, using "Centers of Excellence" where possible.

Incident/Event Response

Maintain certain aspects of the current system, i.e., use of a centralized public event

reporting system, consolidated reports to Congress and coordination of contacts between

Federal and State agencies, with enhancements. Enhancements would include joint development of guidance and procedures for posting event reports to public information

systems and AS assuming greater responsibility for entering event data in public systems. Continued coordination of event response between NRC and AS when necessary would

facilitate prompt notification of all affected parties for events which cross jurisdictional boundaries or involve generic safety concerns. AS would also assume greater responsibility for preparing input for the annual Abnormal Occurrence report.

Generic Assessment for Events

Maintain some elements of the current program with enhancements, including: 1) have AS

assume greater responsibility for generic assessment and for drafting proposed actions; 2) have AS assume a more active role in making decisions on appropriate responses to

significant generic issues; and 3) seek broader input in decision making for long-term actions. Elements of the existing program that would be retained include NRC internal use

of a Generic Assessment Panel (GAP) process and centralized review of proposed actions

for both short- and long-term. This contributes to consistency in regulatory approach over

a period of time and allows all parties an opportunity to participate in decision making.
7.46

APPENDIX C

Summary of Program Elements Evaluations - cont'd

Materials Research

AS and NRC identify research priorities and needs and jointly prioritize common research activities on a national level. Specific individual needs could continue to be funded and carried our as is currently done. Joint, collaborative work could be funded through shared resources, and product scope and acceptance would be jointly determined. For those research projects representing emerging needs for several parties, funding and resource expenditures could be pro-rated for regulatory programs, based on the number of licensees that might benefit from the research product.
7.47

APPENDIX C

Summary of Program Element Evaluations - cont'd

Process for Evaluation of Program Elements

The process used by the Working Group included identification of existing processes or methods

for accomplishing program goals within State and NRC regulatory programs, as well as other

options for each program element. Additional options evaluated by the Working Group included,

in some instances, elimination of the program element as well as alternatives for accomplishing

the specified outcome. Each option, including the existing mechanisms, was evaluated against

criteria defined in the Working Group's Mission Statement. These included:

A. whether the option optimized resources of Federal, State, professional and industry

organizations;

B. whether the option recognized individual program needs and abilities;

C. whether the option promoted consensus on regulatory priorities;

D. whether the option promoted consistent exchange of information between regulatory

programs;

E. whether the option promoted harmonization of regulatory approaches; and

F. whether the option recognized State and Federal needs for flexibility.

The Working Group created a matrix to evaluate options for each Program Element against the

evaluation criteria described above. These evaluation criteria appear as items A through F

(corresponding to the criteria listed above) across the top of each matrix.

Each set of options begins by defining the current methods for accomplishing each program

element. Row I of each matrix represents a baseline from which to evaluate other options.

Subsequent rows represent other options identified for each program element. "O" means the

option was rated equivalent to the existing method or option; "+" means the option was rated as

an improvement for the specific criteria; and "-" means the option was rated as less desirable than

the existing method or option.

Based upon the ratings of all options, the Working Group summarized the results into

recommendations, which are summarized on pages 6.42 through 6.45.
7.48

APPENDIX C

Materials Licensing Guidance

Options

1. No change from current. NRC develops licensing guidance for byproduct, source and special nuclear

material licenses and requests input from AS, and AS also develop guidance for activities that NRC

does not regulate and shares guidance with other States (CRCPD coordinates with States on some

licensing guidance development).

2. NRC/AS jointly develop an agenda and priorities for developing licensing guidance and establish

joint working groups to develop guidance.

3. NRC/AS jointly develop an agenda and priorities for developing licensing guidance and provide direction to an independent entity (CRCPD, ICRP, NCRP, HPS, professional organizations, etc.) that

would develop the guidance documents.

4. No coordination between NRC and AS; NRC and individual AS develop guidance based on

determined needs, including developing no guidance.

5. NRC/AS accept consensus standards for licensing guidance without further evaluation.

A B C D E F

I 0 0 0 0 0 0

2 + + I+ + + 0

3 + + + + + 0

4 1 - 0 - - - 0

5 1+ + 0 + 0 0

Recommendations: NRC/AS jointly develop an agenda and priorities for developing licensing guidance. NRC/AS either use working groups to develop guidance or direct other organizations/entities to develop guidance when appropriate. This recommendation is a combination of options 2 and 3.

Note: One additional potential option was identified and dismissed by the Working Group. This option was

to discontinue licensing certain categories of material (currently authorized under specific licenses) without

substitution of another form of regulatory oversight. The Working Group eliminated this as a viable option and did not screen it. This potential option, if implemented, could have an adverse impact on public health

and safety and is not risk-informed. Thus, it was found to be inconsistent with the strategic goal of protecting health and safety.
7.49

APPENDIX C

Materials Inspection Guidance

.

Options

1. No change from current. NRC develops inspection guidance for its programs and AS develop

guidance for their programs (recognizing that some States choose to adopt guidance in IMC 2800).

2. NRC/AS jointly develop guidance and establish priorities for this work; joint working groups would

be assigned the task of developing guidance.

3. NRC/AS jointly establish priorities for inspection guidance development and either accept available

consensus standards (after revision or approval) or contract other organizations to develop guidance

under NRC/AS direction.

A B C D E F

1 0 0 0 0 0 0

2 + 0 + + + 0

3 1 + I 0 I + + 0O

Recommendations: NRC/AS should jointly establish priorities and develop inspection guidance. Joint

working groups should be used to develop guidance. Alternatively, NRC/AS may also accept consensus

standards (following review and revision, if needed) or contract with other organizations to develop guidance

when not available and needed. This recommendation is a combination of options 2 and 3.
7.50

APPENDIX C

Materials Licensing and Inspection

Alternative for States to Perform Licensing and Inspection

for Al Facilities Within Their Respective State

Options:

1. No change from current. NRC regulates federal facilities and other entities (i.e., exempt distribution

licensees) located within AS.

2. AS is granted statutory authority to perform licensing, inspection and enforcement for Federal

facilities and other entities normally regulated by NRC (i.e., exempt distribution licensees and

others).

3. AS are delegated authority (AS acts as NRC's agent) to perform licensing and inspection for Federal

facilities and other entities normally regulated by NRC (i.e., exempt distribution licensees).

A B C D E F

1 0 0 0 0 0 0

2 0 0 0 0 0

3 0 0 10 0 0 0

Note: Option 2 was found to result in increased resource utilization for regulatory agencies since Master

Materials Licensees, large broad-scope licensees and certain multi-site licensees (i.e., USDA and some U.S.

Army facilities) would no longer perform permitting and inspection activities for their facilities.

Recommendation: No recommendations for change. The Working Group requires input from OGC

regarding legal issues that may be associated with AS either being granted statutory authority or delegated

authority to perform licensing, inspection and enforcement for Federal and other facilities normally

regulated by NRC.
7.51

APPENDIX C

Performing Materials Inspection

Options:

1. No change from current. NRC performs inspections for all facilities authorized to possess/use AEA

material in non-AS and at federal facilities in AS. NRC also performs inspections of general licensees

and exempt distribution licensees located in non-AS and AS. AS inspect facilities located in their

respective States under existing programs.

2. NRC performs all inspections of all licensees in non-AS and AS.

3. AS perform inspections of facilities licensed by the AS, as well as at facilities licensed by NRC within

their respective States. (This option does not take into account any legislative changes required for

AS to perform inspections of federal facilities.)

4. Maintain the current inspection program (Option 1) and allow other entities to contract to perform inspections and report back to the appropriate regulatory agency (i.e., NRC or AS, depending on

facility).

5. Maintain the current inspection program (Option 1) and allow licensees to perform selfinspections/audits (in lieu of inspection by regulatory agency) and report results to appropriate

regulatory agency. Licensee self-audits conducted in lieu of inspection by regulatory agency would

be determined by regulatory agency.

6. Require all States (non-AS and existing AS) to perform inspections of all licensed facilities located

within their respective State.

7. AS performs inspections of AS-licensed activities and NRC-licensed activities when conducting

routine inspections of commercial/academic entities that hold AS and NRC licenses. (No change in

licensing structure, so no legislative changes would be required.)

8. Accept inspections/audits performed by other organizations and use these inspections to supplement

AS/NRC inspection programs. AS/NRC would be selective in accepting results of such inspections.

This could narrow the scope of AS/NRC inspections. (Examples of these organizations include other

regulatory agency inspections or professional/industry organizations.)

9. Maintain current inspection program and supplement with use of "Centers of Expertise" for

performing inspections of specific technical areas. Centers of Expertise could be either AS or NRC

organizations, and would be jointly recognized by AS/NRC.
7.52

APPENDIX C

Performing Materials Inspection

A B C D  ____FF E

1I 0 0 0 0

2 - - l _ - -

3 + _ _ 0 _

4 + + 0 0 +

5 + + 0 0 0 +

6 _ 0 0 0 _

7 + 0 0 + 0 0

8 + + 0 0 0 +

I

I

l I I + I OI+ 0 +

other 

Recommendations: Maintain the current inspection program, but supplement the existing program with

non-AS 

options. NRC would perform inspections for all facilities authorized to possess/use AEA materials in

distribution 

and at federal facilities in AS. NRC would also perform inspections of general licensees and exempt

Supplemental 

licensees located in non-AS and AS. AS would inspect facilities located in their respective states.

inspections 

options would include: 1) allowing other entities to contract with NRC/AS to perform and report results to the appropriate regulatory agency; 2) allowing licensees to perform selfaccept 

audits which may be accepted in lieu of inspection by NRC/AS or reduce inspection effort by NRC/AS; 3)

reduce 

audits performed by other organizations and use these as a supplement to NRC/AS inspections to inspection effort by NRC/AS; and 4) use "Centers of Expertise" to perform inspections of specific technical areas. Acceptance of licensee audits or audits performed by independent organizations NRC/AS to modify inspection effort would be determined by the appropriate regulatory agency in a selective manner. "Centers 

AS/NRC. 

of Expertise" could be either AS or NRC organizations and would be jointly recognized by This recommendation is a combination of options 1, 4, 5, 8 and 9.
7.53

APPENDIX C

Performing Materials Licensing

Options:

1. No change from current. NRC licensed AEA materials in non-AS, all federal facilities, exempt

distribution, and SNM in greater than formula quantities. AS license AEA & NARM in AS and

SNM in less than formula quantities.

2. *Place all program requirements in regulations; require only notification or registration of materials

licensees (name, location, materials to be used).

3. Maintain current program and supplement with contracted entities to perform some license reviews

or portions of reviews for specific technical areas.

4. *Licensees submit abbreviated license applications, indicating program commitments, and

regulatory agencies review for completeness. This option would not require a detailed submittal of

procedures to be used by the licensee.

5. *Maintain the existing license application process, but regulatory agencies perform administrative

reviews for completeness, detailed reviews of licensee procedures would occur during inspections.

6. AS license all facilities within their State (would require change in legislation, but this was not

considered for this program element evaluation).

7. NRC licenses all facilities using AEA material.

8. Maintain current program but supplement with "Centers of Expertise" that could be used to

perform reviews of specific technical activities.

9. Establish "Centers of Expertise," consisting of AS/NRC organizations, that conduct all license

reviews, based on expertise of each organization.

*Options 2, 4, and 5 were not evaluated further because they represent methods for performing materials

licensing rather than organizations that may be assigned responsibility for materials licensing. The Working

Group determined that a change in the level of licensing control should be considered by other working or

task groups. This issue is currently being considered by the Phase II Byproduct Material Task Group.
7.54

APPENDIX C

Performing Materials Licensing

A B C-D E F

I1 0 0 0 0 0 0

3 + I O O O

6 - I 0 0 0 -

7 _ O 0 O

8 + + + 0 + +

9 0 0 0 + -

Recommendation: Maintain the current program and enhance both NRC and AS reviews through use of contracted entities or "Centers of Expertise" to perform some license reviews or portions of reviews for specific technical areas.
7.55

APPENDIX C

Reciprocity

Options

1. No change from current: NRC/AS conduct inspections of licensees when working in respective

jurisdictions, NRC may choose to conduct inspections at AS licensee's home office (to review

activities conducted in areas under NRC jurisdiction), and reciprocity is required and limited to 180

days in any calendar year.

2. NRC/AS do not conduct inspections of licensees working under reciprocity in their respective areas

of jurisdiction and instead contact the licensing/regulating agency to exchange inspection histories.

3. NRC/AS require that the licensee establish an office or record location within the respective area of

jurisdiction.

4. NRC/AS contract with appropriate regulating agency to conduct inspection of activities conducted

under another agency's jurisdiction.

5. Abandon reciprocal recognition of NRC/AS licenses by other regulating agencies and require that

licensees seek a specific license if they choose to conduct licensable activities in areas under another

agency's jurisdiction.

6. Do not limit activities conducted under the provisions of reciprocity to 180 days.

7. Defer this issue to another working group.

The Working Group solicited comments from State stakeholders on this issue since NRC is the only

regulatory agency that enters another agency's domain to conduct inspections of licensees working under

reciprocity. (Note: AS cannot enter another State to conduct inspections of AS or NRC licensees working

within their State.) Based on comments received, the Working Group determined that a recommendation

for change in this area was not warranted at this time. The Working Group's conclusion would not preclude

examination of this process under a separate initiative.
7.56

APPENDIX C

Technical Guidance Documents

Note: Technical guidance documents refer to guidance developed for use by licensees and industry in meeting regulatory requirements. Such guidance may be adopted by licensees to support their program requirements or licensing requirements for both NRC and AS.

Options

1. No change from current. NRC and States develop such guidance or adopt guidance from Standards Development Organizations (SDOs), ICRP, NCRP, or allow licensees to propose guidance; regulatory agencies would review the documents to ensure that they meet agency/regulatory needs. IAEA or ISO guidance would also be considered.

2. Create a Technical Document clearinghouse for submission, evaluation and development of technical documents. 

make 

The clearing house would publish the guidance in a catalog or comprehensive volume to the guidance available to regulatory agencies. IAEA or ISO guidance would also be considered.

3. Allow SDOs to develop guidance and make the guidance available for use by regulatory agencies. (This option would not require acceptance review by NRC/AS.)

4. Contract development of guidance from SDOs based on NRC/AS needs.

| -I-Bi- CJ0D J E IF

1 0 0 10 0 0 0

2 + 0 0 +- 0

3 - - +/0 

4±. 0 ± + I+ F0

1 5 I + I 1 =I _

5. NRC/AS develop guidance documents themselves.

Recommendation: 

approved 

Some organization would maintain a clearinghouse of technical documents evaluated and by the National Materials Program for use. Consensus on priorities, needs and recommendations for organizations to develop guidance should be jointly established by NRC/AS. This recommendation is a combination of options 1 and 2.
7.57

APPENDIX C

Training, Qualifications & Experience Standards

Options

1. No change from current. NRC staff is trained and qualified in accordance with MC 1246, and AS develop and

train staff in accordance with their program requirements. NRC/OAS continue to develop training programs as

an option for States to use. Adequacy of training would be developed during IMPEP reviews.

2. Create central organizations to conduct all training.

3. Maintain Option I and create a clearinghouse of training ideas, resources and opportunities designed for or

employed by regulatory agencies.

4. Allow licensees to provide training, on a voluntary basis, for specific technical issues/activities. Alternatively,

consider contracting with licensees to train regulatory staff in specific technical areas/activities if voluntary

initiatives by licensees are not available.

5. Maintain Option 1 and encourage regulatory agency exchange program to develop staff in specific technical

areas.

6. Have the NMP coordinate and establish priorities for training, with NRC paying for training to "ensure

uniformity." This was determined to be similar to Option 2 with regard to offering flexibility. In addition, it is

based on an underlying assumption that by requiring one regulating agency to pay for all training, uniformity

would be ensured because of contracting constraints and decisions made by a single agency.

A B C D E F

...

1 0 0 0 0 0 0

2 +-+ 0 + _

3 1+ + 0 + ±

4 + + 0 0 0 +

5 + + + + + +

6 - - I - - I - i - I

Recommendation: Maintain the current program and enhance with: 1) use of a clearinghouse of training

ideas, resources and opportunities designed for or employed by NRC/AS; 2) allowing licensees to provide

training , on a voluntary basis, for specific technical issues or consider contracting with licensees to train staff

in specific technical areas; and 3) encourage a regulatory agency exchange program to develop staff in

specific technical areas. This recommendation is a combination of options 3, 4, and 5.
7.58

APPENDIX C

Regulatory Program Reviews

Options

1. No change from current; maintain IMPEP reviews.

2. Eliminate IMPEP reviews and do not replace with alternative; rely upon individual programs to function effectively.

3. NRC/AS implement self-audit programs, evaluating performance against common defined criteria and report to a National Materials Program entity that would be empowered to require corrective action to address deficiencies.

4. NRC/AS implement self-audit programs, evaluating performance against common defined criteria and report to NRC, with NRC empowered to require corrective action to address deficiencies.

5. NRC/AS jointly perform regulatory program reviews more fully utilizing "Centers of Expertise" concept.

6. NRC performs audits of all regulatory programs.

7. NRC/AS contract with an independent entity to perform audits of regulatory programs with results reported to the National Materials Program entity.

Recommendation: Utilize team (NRC/AS) effort in conducting program reviews but fully implement use of "Centers of Expertise" to assist with team composition.
7.59

APPENDIX C

Regulatory Program for General Licensees -

Regulatory Agency

Note: This element refers only to the entity that would regulate general licensees and the general license

program.

Options:

1. No Change from current. NRC and AS use different mechanisms for providing regulatory oversight

for General Licensees, and the level of communication and contact with General Licensees varies

widely among the existing regulatory programs.

2. Return the full General License program to the NRC.

3. Regulatory agencies require that manufacturers of generally licensed devices maintain information

on entities that have received generally licensed devices. This would include maintaining current

information on where the device is located, what entity possesses the device, and information

regarding radionuclides and quantities in an entity's possession.

4. An independent entity could be used to track and monitor use of generally licensed devices for all AS

and NRC.

A B C D E F

1 0 0 0 0 10 0

2 + ° 0 -+-

3 + ± 0 0 + +

4 + + 0 + + +

Recommendation: This needs to be examined concurrently with the following element. The Working Group

recommends that this be discussed with the Steering Committee for consideration of whether a second

working group should evaluate the General License program.
7.60

APPENDIX C

Regulatory Program for General Licensees -Implementation

Note: This element refers only to how the general license program is implemented.

Options:

1. No Change from current. NRC and AS use different mechanisms for providing regulatory oversight for General Licensees, and the level of communication and contact with General Licensees varies widely among the existing regulatory programs.

2. Modify the regulatory program and make all generally licensed devices exempt from regulation.

3. Modify the regulatory program and make all generally licensed devices specifically licensed items.

4. Staff each agency (AS and NRC) sufficiently to implement a general licensee program (this does not consider pending implementation of the registration program for NRC).

5. Require the manufacturers, who are specifically licensed, to monitor and record the distribution and transfer of generally licensed devices and provide reports to the existing regulatory agencies for review.

6. Require that generally licensed devices be leased and not sold. This would result in the

manufacturers retaining some responsibility.

7. Require that manufacturers identify their customers' locations as an additional location of use on the manufacturers' specific licenses. This would result in the manufacturers retaining some

responsibility.

Some of the options were rated by the Working Group; however, given the discrepancies in how these items

are regulated and the number of questions regarding the basis for authorizing distribution and use of generally licensed items, the Working Group elected to discuss this element with the Steering Committee. The Working Group is seeking advice on whether this issue should be reviewed by a separate group.
7.61

APPENDIX C

Certification Programs

Options

Use CRCPD's G-34 Committee Certifying Entity process as an example (with minor modification) of how an

element of a National Materials Program could work. Evaluate successes and problems identified by G-34

during initial implementation of the process, and document input received from G-34 with the working

group's report.
7.62

APPENDIX C

Rulemaking

Options:

1. No change from current. NRC establishes rulemaking agenda, drafts the rule (with AS participation

& input for some rules), establishes compatibility category and requires implementation. CRCPD

working groups modify NRC rules to adapt for state use. CRCPD drafts rulemaking for non-AEA

materials, and States usually adopt these rules. States may also draft rulemaking as needs are

identified.

2. NRC/AS jointly develop a rulemaking agenda and establish a cooperative group to draft rules, using

"Centers of Expertise" where possible.

3. NRC/AS jointly develop a rulemaking agenda, but NRC drafts rules.

4. NRC/AS jointly develop rulemaking agenda, but NRC and States draft rules independently.

5. NRC/AS jointly develop a rulemaking agenda, but an independent entity (NCRP, HPS, CRCPD)

drafts rules for NRC and AS to adopt. (NMEPWG determined that this would not optimize resources

because of the complications involving contracting the entity.)

6. AS jointly develop a rulemaking agenda, and NRC and AS cooperate in drafting rules.

7. AS jointly develop a rulemaking agenda, and NRC drafts rules.

8. AS jointly develop a rulemaking agenda, and states draft rules independently.

9. AS jointly develop a rulemaking agenda, and an independent entity drafts rules for NRC and AS to

adopt. (NMPWG determined that this would not optimize resources because of the complications

involving contracting the entity.)
7.63

APPENDIX C

Rulemaking - cont'd

A B C D E F

1 0 0 0 0 0 0

2 + + + + + 0

3 0 I 0 0 0 0

4 T ± ± I - +

5 = 0 + 0 0 0

6 + 0 + + + 0

7 0 - + 0 + +

8 + + +

9 -0 + 0 0 0

Recommendation: NRC/AS jointly develop a rulemaking agenda and establish a cooperative group to draft

rules, using "Centers of Expertise" where possible.
7.64

APPENDIX C

Information Infrastructure

The Working Group identified the following type of information as necessary to support a National Materials

Program

* Incidents and Events

Used for identification of Generic Safety Issues and to track performance

* Number and Type of Licensees

Specific and General licensees

* Sealed Source and Device Registration Sheets

* Escalated Enforcement Actions

* Regulations

* Licensing and Inspection Guidance

* Radiography Certification Process

For both individual radiographers and States/Organizations approved for certification

* Directory Information

Identifying regulatory agencies, individuals and addresses

* Service Providers

Waste brokers, recycling organizations/facilities, and sealed source recovery services

* OSTP procedures

* Technical Guidance documents

* Program Information (such as provided in OSTP letters)

* Training Information (provided by NRC and other organizations)

* SNM database
7.65

APPENDIX C

Information Infrastructure

The following information systems are currently maintained, but to serve a National Materials Program

effectively, they should have linked access through websites.

Information Maintained by

Rulemaking NRC, SSRCR, States

Radiography Certification OSTP

(States/Organizations approved as certifying entities)

Sealed Source and Device Registration NRC

Licensing and Inspection Guidance NRC, State

Directory Information HPS, CRCPD, STP

Services CRCPD, some States

OSTP Procedures STP, some States

Technical Guidance Documents NRC

Program Information STP, NRC, States

Training NRC, HPS. CRCPD. States
7.66

Appendix C

Incident/Event Response

Options

1. No change from current. NRC maintains centralized information and communication systems to

support receipt of event reports from NRC licensees and AS. These systems are also used to facilitate communication between various State and Federal organizations regarding events that occur nationwide. NRC establishes processes with other Federal and State agencies to support interagency communication and response to events of mutual interest. NRC facilitates contact between AS and Federal agencies regarding events of mutual interest when needed, although AS may contact Federal agencies for assistance independent of NRC. NRC coordinates event response with other Federal agencies when needed, for both AS and NRC licensees. AS report events to NRC, and NRC

determines criteria for reporting event information in public information systems. NRC compiles data for AS and NRC licensee events that meet Abnormal Occurrence criteria and produces an annual report for Congress.

2. AS independently establish and maintain information and communication systems capable of linking with NRC's system, and States upload data required to support a national event reporting database (with public access equivalent to the current systems). AS become responsible for soliciting support from Federal agencies, independent of NRC, through direct contact with the appropriate Federal

agency. Any costs incurred as a result of Federal assistance would be borne by the AS. AS work independently to coordinate event response by multiple States and agencies when incidents or events involve multiple regulatory jurisdictions. AS submit information directly to public information

systems in accordance with criteria established by NRC. NRC compiles data for AS and NRC licensee events that meet Abnormal Occurrence criteria and produces an annual report for Congress.

3. NRC and AS receive event notifications and respond independently. Each regulatory agency maintains information and communication systems as deemed necessary to support individual

agency functions. No centralized event notification/reporting database exists. Responsibility for coordinating communications and response for events that cross jurisdictional boundaries would rest with the affected agencies. AS submit annual reports of events that meet Abnormal Occurrence

criteria to NRC and NRC forwards State reports to Congress collectively with NRC's annual report.

4. NRC and AS jointly establish and maintain an event reporting information system that is accessible

to the public. (This would not necessarily replace internal systems used by States or NRC.) NRC and AS review and establish criteria and procedures for posting event reports in public information

systems. NRC and AS jointly establish and maintain communications networks to facilitate coordinated communications and response, at State and Federal levels, to events for which an AS

may need Federal assistance and those which cross jurisdictional boundaries. NRC and AS

collaborate on producing an annual report on those events that meet Abnormal Occurrence criteria.
7.67

Appendix C

Incident/Event Response - cont'd

-- M --- -

A B C D E F

1 0 0 0 0 0 0

1 O a

2 0- - -0 _

3+ I+ +I

4 ± 0 ± + +I0

Recommendations: Maintain certain aspects of the current system, i.e., use of a centralized public event

reporting system, consolidated reports to Congress and coordination of contacts between Federal and State

agencies, with enhancements. Enhancements would include joint development of guidance and procedures

for posting event reports to public information systems and AS assuming greater responsibility for entering

event data in public systems. Continued coordination of event response between NRC and AS when

necessary would facilitate prompt notification of all affected parties for events which cross jurisdictional

boundaries or involve generic safety concerns. AS would also assume greater responsibility for preparing

input for the annual Abnormal Occurrence report. This recommendation is a combination of options 1 and

4.
7.68

Appendix C

Generic Assessment for Events

Options

1. No change from current. NMSS reviews incoming event reports (ENs, PNOs and MRs) and discusses the reports and related information with regional counterparts. Information is developed for each event through interactions with regional and OSTP staffs who, in turn, have gathered additional information from NRC licensees and AS counterparts to support generic risk/safety assessments. NMSS also uses information from the NMED database, Department of Energy weekly reports and other 

NMSS 

operational 

managers 

data to support weekly reviews by a Generic Assessment Panel (GAP) consisting of and staff. The GAP makes decisions regarding significance of the issue and forwards the issue to a lead division for review, which may result in a short-term follow up action, or recommends 

Monthly 

that the issue be discussed during a monthly briefing with senior NMSS management. operational event briefings are supported by NMSS, regional and OSTP staffs, with occasional support from AS staffs. Senior NMSS management determines whether significant issues should be considered for long-term action, such as revision to existing guidance or rulemaking. Events requiring long-term actions are tracked for implementation status by NRC.

2. The NMSS regional coordinator(s) works with regional counterparts to develop information to support generic risk/safety assessments from existing sources (i.e., licensees, NMED, AS staff, and other operational data sources). Regional staffs work with AS representatives as needed to develop information about events reported by AS licensees. The GAP conducts weekly event reviews, with support from regional and HQ staffs, and determines whether an event should be assigned to a lead division for review (events of lesser significance which may require short-term action) or referred for briefing at the monthly Operational Events briefing. Monthly Operational Event briefings are supported by NMSS and regional staff. Senior NMSS management determines whether significant issues should be considered for long-term action, such as revision to existing guidance or rulemaking. Events requiring long-term actions are tracked for implementation status by NRC.

3. NRC regional and NMSS staff develop information relating to events reported by NRC licensees and other 

managers 

operational data to support generic risk/safety assessment. NRC regional and NMSS staff and

licensee 

conduct generic risk/safety assessment (this may be done using the GAP process) for NRC events. AS develop information relating to events reported by AS licensees and conduct generic risk/safety assessments. NRC and AS determine which of their licensees' events should be reviewed for potential short-term action, based on potential generic implications, and which events

actions 

are significant enough to be considered for long-term action based on common criteria. Short-term are implemented by the NRC and AS, but the substance of the action and information concerning the event is shared between AS and NRC. Information relating to significant events identified as candidates for long-term action is reviewed monthly during a joint Operational Events briefing in which AS and regional staff provide input regarding their respective events and perspectives on appropriate long-term actions. NMSS determines what long-term action should be implemented 

NRC 

(with input from AS and regions) when NRC has the lead for implementing the action. would track the status of implementation for these actions. AS could implement actions within their respective programs, as deemed appropriate.

i
7.69

Appendix C

Generic Assessment for Events

4. NRC regional and NMSS staff and managers conduct generic risk/safety assessment (this may be

done using the GAP process) of events reported by NRC licensees. AS develop information relating

to events reported by AS licensees and conduct generic risk/safety assessments. NRC and AS

independently determine which of their licensee's events should be reviewed for potential short-term

action, based on potential generic implications, and which events are significant enough to be

considered for long-term action. Each agency provides recommendations on proposed actions (i.e.,

indication that there is no generic implication, draft Information Notice or recommendation for rule

change) to NMSS, which serves as a point of contact for monthly Operational Events briefings.

Recommendations for action are reviewed jointly (NMSS, regions and AS) during the monthly

briefing and a decision is reached on the appropriate course of action.

A B C D E F

1 0 0 0 0 0 0

2 1+ 0 10 + I0 0

3 1+ 0 i- + - +

4 1+. 0 + + + 0

Recommendations: Maintain some elements of the current program with enhancements, including: 1) have

AS assume greater responsibility for generic assessment and for drafting proposed actions; 2) have AS

assume a more active role in making decisions on appropriate responses to significant generic issues; and 3)

seek broader input in decision making for long-term actions. Elements of the existing program that would be

retained include NRC internal use of a GAP process and centralized review of proposed actions for both

short- and long-term. This contributes to consistency in regulatory approach over a period of time and

allows all parties an opportunity to participate in decision making. This is a combination of options 1 and 4.
7.70

Appendix C

Materials Research

ODtions

1. NRC conducts or contracts research projects with costs passed through to NRC licensees. Products

of these efforts are generally used to develop generic guidance or, less frequently, to address licensespecific issues. Products are public documents and are therefore available for the benefit of AS

regulatory programs and licensees, as needed. Research products developed by AS generally benefit

State licensees and funding mechanisms are determined in accordance with State requirements.

2. AS continue to identify and fund research activities according to each AS's priority or need. NRC

continues to identify and fund research activities according to its priorities or need. AS and NRC

make the research products available to all through a centralized information "clearing house" for

the benefit of all regulatory programs and licensees.

3. AS and NRC identify research priorities and needs and jointly prioritize common research activities

on a national level. Specific individual needs could continue to be funded and carried out as is

currently done. Joint, collaborative work could be funded through shared resources, and product

scope and acceptance would be jointly determined. For those research projects representing emerging needs for several parties, funding could be pro-rated for regulatory programs, based on the

number of licensees that might benefit from the research product.

A B C D I E F

1 o 0 1 0 I0 0

2 + 0 0 + 0 0

3 + 0 + + + +

Recommendation: AS and NRC identify research priorities and needs and jointly prioritize common research

activities on a national level. Specific individual needs could continue to be funded and carried out as is

currently done. Joint, collaborative work could be funded through shared resources, and product scope and

acceptance would be jointly determined. For those research projects representing emerging needs for several

parties, funding and resource expenditures could be pro-rated for regulatory programs, based on the number

of licensees that might benefit from the research product.
7.71

Appendix D

Relative Decision Matrix

The decision matrix is a tool decision-makers can use to assist them in solving problems with

multiple, and often competing, evaluation criteria or options. This decision tool is taught at

Harvard University and is used among many groups including federal agencies such as the

Department of Agriculture and the United States Army. The decision matrix software used by the Working Group was developed for use at the Combined Arms and Services Staff School

(CAS3) at the U.S. Army Command and General Staff College, Fort Leavenworth, Kansas. The

program author was a 1997 graduate of CAS3. The program is considered freeware and is

intended for dissemination throughout the U.S. Army.

The Working Group used simple non-weighted decision matrices to evaluate the program elements. The Working Group used a "Relative Value" decision matrix to compare all of the

final options for a National Materials Program against weighted criteria. The matrix reveals that

the logic used by the Working Group was sound when the Working Group recommended the

Alliance Option.

The purpose of this appendix is to explain how a decision matrix works and how it can be used in

making decisions. A decision matrix compares available options against chosen evaluation

criteria that all of the options must meet. Usually in a decision matrix, one criterion is more

important in the decision making process than all of the others and a weight factor is assigned to

the criterion. For the National Materials Program, protecting public health and safety is the most

important evaluation criterion considered. All other criteria being evaluated follow in order of

priority and are assigned a weighting factor in the pairwise comparison chart, with the larger values having the most weight. The assignment of weighting factors will make some evaluation

criteria more important and some less important. The pairwise comparison chart of the decision

matrix process is a structured approach that establishes criteria weights and then applies these

weights within the decision matrix. A discussion of the pairwise comparison chart is detailed

below.

A basic decision matrix shell is shown in Figure 7.1. Evaluation criteria are shown along the top of the matrix. By convention, evaluation criteria are shown in order of descending weight from

left to right in the matrix. Options are shown along the left side of the matrix.

The decision matrix program calculates the totals of each option and shows the values in the far

right column of the matrix. Within the decision matrix the lower values are better. The program also re-calculates the option totals whenever a value is changed. The type of matrix selected

(Relative Value (RV) or Multiplication) and the Consistency Ratio is shown at the bottom right of the matrix.
7.72

Appendix D

Relative Decision Matrix

Figure 7.1

Weight WI W2 Total

Criterina _______

Option_ _ __ _ _

RVI RV2 Total RV

RVl RV2 Total

Type of Nhtrix Relative Valu

Less Is Better

Consistency Ratio =

Either a relative value matrix (RV) or a multiplication matrix can be used for the decision

making process. The relative value matrix is the easier of the two methods to use. It is the

method of choice when evaluating criteria that do not have a real number values associated with

the criteria, i.e. comparing intangibles such as protecting public health and safety, improving

public confidence or promoting consensus.

The multiplication matrix is more accurate and used when comparing the magnitude of

difference between measurable values. For example, when comparing different types of cars one

may be interested in purchasing, a multiplication matrix may contain criteria such as a

comparison of actual miles per gallon, cost of the vehicle, cubic feet of cargo space, and mean

time between maintenance. This method cannot be used if the Evaluation Criterion cannot be

expressed with a numerical value.

The type of matrix used for the Decision Matrix in Section IV is the relative value matrix. This

matrix ranks the option based on the value obtained by ranking each option against each of the

evaluation criteria. The best option for a particular criterion is assigned a value of one (1). The

remaining options are then ranked, ordering them within that evaluation criterion. If two or more

options have the same value within a given evaluation criterion, their rankings are averaged and

the average is assigned to each of the options. For Example: Two options are tied for the 2nd

and 3rd ranking. ((2+3) /2 = 2.5) Therefore 2.5 would be assigned to the two options and the

next option would be assigned a value of four (4), etc.
7.73

Appendix D

Relative Decision Matrix

Each relative value is put in the appropriate box corresponding to that combination of option and

evaluation criterion. The relative value method computes the total for each option by adding the

products of each relative value of the evaluation criterions multiplied times the evaluation

criterion's weight for each evaluation criterion along an option row as follows:

(RVl)(W1) + (RV2)(W2) + . + (RVn)(Wn) = Total REL VAL

Where: RVn = Relative Value for the assigned value of the nth Evaluation Criterion

Wn = Weight of the nth Evaluation Criterion

The pairwise comparison is the technique used to translate a comparison of the relative

importance of the evaluation criteria into numerical values and then a mathematical model

determines an appropriate weight to accurately reflect the logic. The pairwise comparison lends

objectivity to what otherwise would be a simultaneous subjective ranking of many criteria -- something the human mind has difficulty doing. The completed pairwise comparison chart that

was used for the relative value matrix in Section IV is shown in Figure 7.2 of this appendix.

To determine criteria weights using the pairwise comparison techniques the evaluation criteria

are ranked in order of general importance. Factors and their values for criteria comparison are:

(1) Equal, (2) Slightly Favored, (3) Favored, and (4) Strongly Favored. These are used to input

the numerical importance factor into the chart by comparing each of the evaluation criteria

against each of the other criteria. The following example shows the process by which one can

determine the pairwise comparison:
7.74

Appendix D

Relative Decision Matrix

EXAMPLE:

Which evaluation criterion (EC) is more important ... EC #1 or EC#2?

Answer: EC#1

By what importance factor?

Answer: 4 (Strongly Favored)

The importance factor 4 is entered in the box at the EC #1 -EC#2 intersection.

II C#2 | EC#3 I EC#4

BC#l 4 4 4

EC#2 2 3

EC#3 ]

The evaluation of all pairs is continued until the chart is complete.

Next a logic check is conducted. In general, importance factors increase in value or are equal in

value as you move from left to right along a row of the chart. If the importance factors do not

consistently increase or remain the same as you move from left to right in the chart one of two

conditions could exist:

(a) Evaluation criteria ranking are out of order: To solve this problem, reorder the order

the evaluation criteria and repeat the pairwise comparison; or

(b) The logic of the pairwise comparison is incorrect. To solve this problem, the

importance factors must be reevaluated.

An additional logic check is conducted within a given evaluation criterion. The values should

decrease or remain the same as you move from top to bottom in the chart. Once all of the values

are entered in the pairwise comparison chart, the computer calculates the weights for each of the

evaluation criteria and imports those values to the decision matrix. The mathematical model that

determines the criteria weighting is based on the Eigenvector method described in the

monograph "Lecture Notes in Economics and Mathematical Systems." The methodology for

solving the Eigenvalues for a specific Eigenvector is described in the book, Matrices and

Transformations.
7.75

Appendix D

Relative Decision Matrix

Figur 7.2

Pairwse Coprison Clt

otini2e Pitnu Axmt for exibdW Fcwgecf Hamiize Public

RaUrc Cono-as Indivicdw Infcmkion Reguliy Conficmre

Nees Approw

Sbirtairs

Saf*

4 4 4 4 4 4 4

4 4 + 4I

qmini

RobAZeS

2 2 2 2 3 2 1 .4. 4

PrOn~te

Consaa 1 1 1 1 1

urfoulfor

Individual

Needs

1 1 1 I

4 4- 4

Flexibility 1 1 1 - . o.

hfTntim 1 1

Hareiz

Roultye

AIwdrs

1

Lerad of hnportase Factors

1 -Equal

2- SligWyFavored

3 - Favored

4- SitonglyFawred

After the criteria weights have been determined, the program determines the consistency ratio.

The consistency ratio uses a least squares method to measures how well the pairwise comparison

values maintain a logical series of relationships.

The consistency ratio is shown as a percentage below the right side of the decision matrix. For

this mathematical model, a consistency ratio of 95% or more means the logic of the pairwise

comparison is acceptable using the weighting factors produced by the decision matrix program.

If a consistency ratio below 95% results, an error box appears in the program. If a value below

95% occurs, the pairwise comparison must be re-evaluated for logic errors. The mathematical

model that determines the consistency ratio is based on the method described in the book,

Spreadsheet Modeling and Decision Analysis: A Practical Introduction to Management Science.
7.76

Appendix D

Relative Decision Matrix

With a large number of evaluation criteria, the program model may not catch a single, obvious

error in the pairwise comparison logic. This limitation of the model makes conducting the logic check very important, i.e. the user must ensure the pairwise comparison importance factors generally increase or are equal in value, as you move from left to right along a row of the chart.

Together with the consistency ratio, sensitivity analysis is a measure of the subjectivity of the

decision matrix. Sensitivity analysis identifies the degree to which the decision matrix results are

subject to change with only small changes in the evaluation criteria weights. A solution that is

not sensitive to changes in weights provides the decision-makers with confidence that they have

a valid solution. A solution that is "sensitive" to changes in weights is a red flag for the

decision-maker. With a sensitive solution, the decision-maker must review the Pairwise

relationships of the criteria to see if they really reflect the decision-maker's understanding of the

relative importance of each criteria.

The program conducts sensitivity analysis by changing each Evaluation Criterion weight of 1.0

or more independently, within a range of plus or minus three points, and recalculates the matrix

to determine whether the solution changes. The program resets the criterion weight to its original value and proceeds to analyze the sensitivity of the next Evaluation Criterion.

For example: For an Evaluation Criterion weight of 2.38, the program:

Sets the weight incrementally lower by hundredths of a point (e.g., 2.37, 2.36, etc.), it

recalculates, and determines the weight where the solution may change. NOTE: In this

example, the program does not set the value lower than 1.00 and therefore does not

complete the calculation within the full range of -3.

Next the program sets the weight incrementally higher by hundredths of a point (e.g., 2.39, 2.40, etc.), recalculates, and determines the weight where the solution may change. The program stops calculating at the weight of 5.38 to complete the range of +3.

After this calculation is completed the program resets the weight to the original value of

2.38 and moves to analyze the next Evaluation Criterion.

The Sensitivity Analysis for the decision matrix used in Section IV, Recommendations, is shown

in Figure 7.3.
7.77

Appendix D

Relative Decision Matrix

N

Figure 7.3

SENSfIIIYANALYSIS

Nhintains Safety Not Sensitive

Optimizes Resources Not Sensitive

Promrte Consensus Not Sensitive

Regulatony Approaches Not Sensitive

Exchange of Infopmtion Nt Sensitive

Public Confidence Not Sensitive

Account for Individual Needs Not Sensitive

Flexibility Not Sensitive

The decision matrix program calculates the totals of each option and shows the values in the far right column of the matrix. The program will re-calculate new totals whenever a value is

changed.

The decision matrix is an important tool for making decisions more objective, especially when

there are numerous evaluation criteria to be compared to a number of possible options. By using

a decision matrix, or similar method, a high degree of confidence is built into the decision

making process.
8.1

Section Vill

Bibliography

Atomic Energy Act of 1954

Combined Arms and Services Staff School (CA) U.S. Army Command and General Staff

College, Ft. Leavenworth, Kansas. Decision Matrix Program (DECMAT) and DECMAT Help

file.

Code of Federal Regulation, Title 10.

Conference of Radiation Control Program Directors. Criteria for an Adequate Radiation

Control Program. CRCPD Publication 99-2, April 1999.

Hwang, Ching-Lai and Kwangsun Yoon. "Lecture Notes in Economics and Mathematical

Systems." (186: Multiple Attribute Decision Making: Methods and Applications). SpringerVerlag, Berlin, 1981.

M. Broderick (OK Dept of Environmental Quality), J. Jacobi, (CO Dept of Public Health and

Environment), V.D. Jeffs (KY Dept for Public Health). Rational for a Single Radiation Control

Agency: A Report of Task Force on Radiation Priorities. Task Force on Radiation Priorities, G44, CRCPD, Draft October 6, 1999.

NRC Management Directive 5.6, Integrated Materials Performance Evaluation Program.

NRC Management Directive 5.9, "Adequacy and Compatibility of Agreement State Programs."

February 27, 1998.

Nuclear Licensing Reports, Vol. 14, No. 1, January 2000.

OSP Procedure SA-200. "Compatibility Categories and Health and Safety Identification for

NRC Regulations and Other Program Elements." February 6, 2001.

Pettofrezzo, Anthony J. Matrices and Transformations. Dover Publications, Inc. NY, 1966.

Ragsdale, Cliff T. "Spreadsheet Modeling and Decision Analysis: A Practical Introduction to

Management Science, 2nd Edition," South-Western College Publishing, Stamford, Connecticut,

1997.

SECY-99-250 "National Materials Program: Request Approval of the Formation of a Working

Group on the Increase in the Number of Agreement States and Impact on NRC's Material

Program," October 14,1999.

Topical Discussion of NRC Agreement State Programs, OAS, 1994.